PAGENO="0001" 1980 AUTHORIZATION FOR THE OFHCE OF RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY DEPOSITORY HEARINGS BEFORE THE SUBCOMMITTEE ON NATURAL RESOURCES AND ENVIRONMENT OF THE COMMITTEE ON SCIENCE AND TECHNOLOGY U.S. HOUSE OF REPRESENTATIVES NINETY~SIXTH CONGRESS FIRST SESSION FEBRUARY 13 AND 15, 1979 [No. 5] Printed for the use of the Committee on Science and Technology UIGERS LAW SCHOOL UBRM~ K CAMDE~~ J. 08102 t~OVERNME~ DOCUMENI U.S. GOVERNMENT PRINTING OFFICE 43-7780 WASHINGTON: L979 A~G 201979 `4b c~1 ~i~i~r PAGENO="0002" COMMIII'EE ON SCIENCE AND TECHNOLOGY ROBERT A. ROE, New Jersey MIKE McCORMACK, Washington GEORGE E. BROWN, JL,~Cal1fornla JAMES IL SCHEUER, New York RICHARD L. OTTINGER, New York TOM HARKIN, Iowa JIM LLOYD, California JEROME A. AMBRO, New York MARILYN LLOYD BOUQUARD, Tennessee JAMES J. BLANCHARD, Michigan DOUG WALGREN, Pennsylvania RONNIE G. FLIPPO, Alabama DAN GLICKMAN, Kansas ALBERT GORE, Ja., Tennessee WES WATKINS, Oklahoma ROBERT A. YOUNG, Missouri RICHARD C. WHITE, Texas ~IAROLD L~ VOLKMER, Missouri DONALD J. PEASE, Ohio HOWARD WOLPE, Michigan NICHOLAS MAVROULES, Massachusetts BILL NELSON, Florida - BERYL ANTHONY, JR., Arkansas STANLEY N. LUNDINE, New York ALLEN E. ERTEL, Pennsylvania KENT HANCE, Texas .T~HN W. WYDLIIII, New York LARRY WINN,JL, Kansas ~BARRY M~ GOLDWATER, JR., California HAMILTON FISH, JR., New York MANUEL LUJAN, Ja., New Mexico HAROLD C. HOLLENBECK, New Jersey ROBERT K. DORNAN, California ROBERT S. WALKER, Pennsylvania EDWIN B. FORSYTHE, New Jersey KEN KRAMER, Colorado WILLIAM CARNEY, New York ROBERT W. DAVIS, Michigan TOBY ROTE, Wisconsin DONALD LAWRENCE RITTER, Pennsylvania DON FUQUA, Florida, Chairman HAROLD A. GOULD, Executive Director PHILIP B. YEAGER, General Counsel REGINA A. DAVIS, Chief Clerk PAUL A. VANDER MYDE, Minority Etaff Director SUBCOMMITTEE ON NATURAL RESOURCES AND ENVIRONMENT JEROME A. AMBRO, New York Chairman GEORGE E. BROWN, JR., California ROBERT S. WALKER, Pennsylvania JAMES J. BLANCHARD, Michigan EDWIN B. FORSYTHE, New Jersey WES WATKINS, Oklahoma DONALD LAWRENCE RITTER, STANLEY N. LUNDINE, New York Pennsylvania IAN W. MARCEAT, Staff Director RADFORD BYERLY, Jr., Science Consultant LOREN D. LANGE, Congressional Fellow (II) PAGENO="0003" C.. ~ Z 4~ -P -~ C) rP (I) CD -* D ~ C) C) CD) )0CD00CCD-- CD CD000 CD 0cD-,CDCD0O.CDCD CD )flCDCDCD 0 3 --3 CD 03 -~ 09--* CD C) C) < -~- > CD ~ CD -. -~. 0 ~P 0 CD ~+(L) .0 CD -~ + CD -~ CD CDDj~ ~ ~ 0) CD-~.CDCD0CD-CDCD OCD ~C) 3 CD (+0 ~< * 0 CD CD C) CD ~`1 CD (*OCD - 0)3 CD~ 0 C )+ CD 0 CD -C CD CD -)- 3 -~ CD CD .0 0 CD CD ~P 0. 0 CD -~ )* -~- ~ C CD CD CDCO-P ) -U) CD ,-C ~O)-- 9 (~t C) -~. 0 = CD (7 0 0 CD CD C) -~ 0CC CD~-- CDCDCDO to CD -CD ~ CDCD~ C) - CD0.C)CD(+0.CD N3CD C_C_CD )p_p~CDCDCD (JCCD CD -lCDm -~ (7)0. -1 * C_p (7 to (+0 to CD ) )* -4 CD~ CD 0)0(0 CD mo >C) -= <2 plo U1r 0 C) -C PAGENO="0004" PAGENO="0005" CONTENTS WITNESSES February 13, 1979: Page Dr. Stephen J. Gage, Assistant Administrator for Research and Devel- opment, EPA; accompanied by Dr. William Murray, Acting Deputy Administrator for Health and Ecological Effects; Dr. Thomas A. Murphy, Deputy Assistant Administrator for Air, Land, and Water Use, and Dr. Courtney Riordan, Associate Deputy Assistant Admin- istrator for Air, Land, and Water Use; Dr. Steven P. Reznek, Acting Deputy Assistant Administrator for Energy, Minerals, and Industry; and Mr. Albert C. Trakowski, Deputy Assistant Administrator for Monitoring and Technical Support 2 February 15, 1979: Dr. James N. Pitts, Jr., Director, Statewide Air Pollution R~esearch Center, University of California, Riverside 133 PANEL ON DRINKING WATER Robert J. Flynn, Chairman, Suffolk Couuty Water Authority, Hunting- ton, N.Y.; accompanied by Walter Hazlitt, William Schickler, and August Guerrera; Foster S. Burb4, President, Louisville Water Co., Louisville Ky.; accompanied by Mr. George Pendygraft 157 PANEL FROM THE SCIENCE ADVISORY BOARD'S HEALTH EFFECTS RESEARCH REVIEW GROUP Dr. James L. Whittenberger, Professor of physiology, School of Pub- lic Health, Harvard University, Boston, Mass.; Dr. Julius E. John- son, cOnsultant (formerly Vice President of research and develop- ment) Dow Chemical Co., Midland, Mich 174 APPENDIXES 1. EPA Report, "The Planning and Management of Research and Develop- ment Activities Within EPA: A Report to the President and the Con- gress," June 30, 1978 186 2. Letter to Hon. George E. Brown, Jr., from Douglas M. Costle, January 3, 1979, transmItting "Status Report to the Congress: Pilot Study of the Revised Planning and Management System for Research and Develop- ment in the Environmental Protection Agency." 234 3. Letter to Hon. Jerome A. Ambro, from Basil Snider Jr., president, Garden State Paper Co., Inc., March 27, 1979 248 4. Report of the Health Effects Research Review Group, U.S. Environ- mental Protection Agency, Science Advisory Board, February 1979~ 250 5. Summary statement from the EPA Advisory Panel on Hea~lth Effects of Photocl~emical Oxidants, January 1978 354 6. Revision of the National Ambient Air Quality Standards for Photo~ chemical Oxidants, final rule, U.S. Environmental Protection Agency, January 1979. (Summary, availability of related information, supple- mentary information, background, and summary of general findings from air quality criteria for onone and photochemical oxidants.) 378 7. Letter from S. L. Terry, Vice President, Public Responsibility and Con- sumer Affairs, Chrysler Corporation 892 (V) PAGENO="0006" PAGENO="0007" 1980 AUTHORIZATION FOR THE OFFICE OF RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY TUESDAY, FEBRUARY 13, 1979 U.S. HOUSE OP REPRESENTATIVES, COMMITTEE ON SCIENCE AND TEChNOLOGY, SUBCOMMITTEE ON NATURAL RESOURCES AND ENVIRONMENT, Wa~1iington, D.C. The subcommittee met, pursuant to call, at 10 a.m., in room 2825, Rayburn House Office Building, Hon. Jerome A. Ambro (chairman) presiding. Present: Representatives Ambro, Brown, Blanchard, Walker, and Ritter. Mr. AMBRO. I think it is about time to get started. If I may, I would like to say that today's hearing opens a new Congress with a subcom- mittee with a new chairman. The Subcommittee on Natural Eesourc~s and Environment has the same jurisdiction as the Subcommittee on the Environment and the Atmpsphere had in the 95th Congress with the addition of water, materials, and agricultural research. Therefore, there is a certain amount of continuity in the subcommittee and the appearance of Dr. Stephen Gage, a familiar face, to present the En- vironmental Protection Agency's research budget continues the Sci- ence Committee's oversight over that program. I want to welcome to the subcommittee Congressman Donald Ritter of Pennsylvania and say, too, that we have, it seems to me, a quality subcommittee in that we have the good fortune of having on it George Brown of California who was the previous chairman of this subcom- mittee, now the chairman of the Subcommittee on Science, Research, and Technology. We have Mike McCormack, another subcommittee chairman, and Bob Walker will be back and who was the ranking minority member last time. I think that we can say to the EPA that we look forward to a fruit- ful relationship. Because there have been several changes, I want to go quickly over our schedule for the balance of the week. At 4 this after- noon in this room we will have a subcommittee planning meeting. The hearings will continue tomorrow at 4 p.m. in this room if we don't complete our business today and it becomes necessary that Dr. Gage and staff reappear tomorrow at 4 p.m. On Thursday afternoon at 2~ in room 2253 we will have several public witnesses testifying on the various aspects of EPA's research program~ (1) PAGENO="0008" 2 There are a great many issues in the EPA budget, but I want to men- tior~ one broad issue that has many specific manifestations. The budget shows a major increase in health effects. The issue, therefore, is should the Agency continue to work to identify environ- mental hazards without developing the necessary control technologies to deal with those hazards and take. remedial action? That is an issue in which, of course, I am most interested. Should there not be, in other words, a linkage between the development of health-based standards and the development of technology to miti- gate the hazard or perceived hazard? Concerning public health, one must ask whether the public health is served more by looking for potential health threats, or by developing technology to eliminate the~ health threats that we already know. As I say, there are many other issues and plans. The best thing is to hear about the budget and get to the specifics. I would like to wel- come Dr. Stephen Gage, the Assistant Administrator for Research and Development, Environmental Protecti~m Agency. STATEMENT OP STEPHEN ~r. GAGE,. ASSISTANT ADMINISTRATOR FOR RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL PRO- TECTION AGENCY, ACCOMPANIED BY WILLIAM MU~RAY, ACT- ING DEPUTY ASSISTANT ADMINISTRATOR FOR HEALTH AND ECOLOGICAL EFFECTS; THOMAS A. MURPHY, DEPUTY ASSISTANT ADMINISTRATOR FOR AIR, LAND, AND WATER USE, AND Dk COURTNEY RIORDAN, ASSOCIATE DEPUTY ASSISTANT ADMINIS- TRATOR IN THAT OFFICE; STEVEN R. REZNEK, ACTING DEPUTY ASSISTANT ADMINISTRATOR FOR ENERGY, MINERALS, AND IN- DUSTRY; AND ALBERT C. TRi~KOWSKI, DEPUTY ASSISTANT AD- MINISTRATOR FOR MONITORING AND TECHNICAL SUPPORT Dr. GAGE. Thank you, Mr. Chairman.. I am pleased to be here today with my colleagues from the Office of Research and Development. I would like to introduce them at the onset. On my right is Dr. Courtney Riordan, Associate Deputy Assistant Administrator for Air, Land, and Water Use. Next to him is Dr. Steven R. Reznek, Acting Deputy Assistant Administrator for En- ergy, Minerals, and Industry. Next to him is Dr. Thomas A. Murphy, Deputy Assistant Administrator for Air, Land and Water Use. To my left is Dr. William Murray, Acting Deputy Assistant Administra- tor for Health and Ecological Effects; and next to him Albert C. Trakowski, Deputy Assistant Administrator for Monitorin.g and Technical Support. I would like to begin by reviewing several highlights of our ac- tivities during the past year. This past year saw us focusing a great deal on a number of management issues which we thought we had to come to grips with in order to improve the planning and implementa- tion of the large number of Office of Research and Development programs. As we discussed several times last year before this subcommittee, we did initiate a series of pilot research committees which could be PAGENO="0009" 3 used to effect joint planning of the research and development efforts with our regulatory program offices. We established five committees, as I indicated, in the areas of pesticides, industrial waste water, mo- bile source air pollution, inhalable particulates, and drinking water. These 5 pilot research committees worked quite successfully, and we are in the process now of expanding those 5 to 12 to cover substan~ tially all of the research and development efforts that we conduct in support of Our regulatory colleagues. These new research committees are being started right now, and we will have joint membership with the Agency's regulatory, regional, enforcement, and planning and management offices. Mr. Chairman, the relevant program offices are shown around the outside of the chart, and our regional offices will be represented on each committee. In the inner part of the chart are the 12 research commit~ tees-there are actually 13, but we are deferring starting one in chemi- cal control until that program grows and takes on a greater confirma- tion than it has at this particular point. These research committees are responsible for developing 3- to 5-year plans in the several areas. In addition, these research committees iden- tify the actual tasks and projects that have to be performed in the up'- coming budget year, and participate in the preparation of the decisio~i units which we use in our zero-based budgeting process. [The following question and answer were submitted for the record:] Question. Will the three to five year plans developed by the research planning committees eventually become the building blocks for the five year plan? Will the five year plan and your budget eventually be organized according to the research~ planning committee structure? Please supply a matrix showing how the 12 re- search committees interact with the present budget request program categories. Answer. We expect the committees to impact our planning in two respects. First, we envision a strong and dynamic relationship between our overall five year plan and the three to five year plans developed by the individual committee~. We regard the committees' plans as a major factor in the preparation of the over-j all plan. Second, as I indicated earlier, the committee's efforts will be strongly reflected in our Decision Units. With these two things in mind, we are considering improving our program presentation by aligning the structure of our Decision Units, budget submission, and five year plan with the overall committee structure. We have thus taken a first step in mapping our program against the committe~e structure. I shall leave copies of a chart which lists the committees which will be operational this year. The chart shows those portions of our program, by category from the FY 1980 budget submission, to be addressed by each committee. Activi- ties such as "Health Effects" research, are aligned by the respective committees' subject areas, such as "oxidants" or "hazardous air pollutants". Activities of the Office Of Research and Development to be planned bij research committees Activities as given in the flscai year 1980 budget Research Committee subject areas submission to the Congress Mobile source air pollution__ Air/health effects, air/characterization and measurement methods development, air/trans. port and fate of pollutants, air/monitoring methods and systems, air/technical support, air/quality assurance. Oxidants Air/health effects, air/ecological processes and effects, air/characterization and measurement methods development, air/transport and fate of pollutants, air/industrial processes, air/ monitoring methods and systems, air/technical support, air/quality assurance. PAGENO="0010" N 4 Activities of the 0/flee of Research avid Development to be planned by research committees-Continued Actlvitie~ as given in the fiscal year 1980 budget Re8earch Committee 8ubjeot areas submission to the Congre8s Gaseous and inhalable particu- Air/health effects, air/ecological processes and late pollutants, effects, air/characterization and measurement methods development, air/transport and fate of pollutants, air/industrial processes, alr/ monitoring methods and systems, air/tech- nical support, air/quality assurance. Hazardous air pollutants Air/health effects, air/ecological processes and effects, air/characterization and measurement methods development, air/transport and fate of poll~itants, air/industrial processes, air/ monitoring methods and systems, air/tech- nical support, air/quality assurance. Nonionizing radiation Radiation/health effects. Water quality Water quality/health effects, water quality/ ecological processes and effects, water quality/ transport and fate of pollutants, water qual- ity/renewable resources, water quality/char- acterization and measurement methods devel- opment, wat~r quality/Chesapeake Bay, water quality/Great Lakes, water quailty/monltor- ing methods and systems, water quality/ technical support, water quality/quality assurance. Municipal wastewater, ocean Water quality/health effects, water quality/. disposal and spill preven- ecological processes and effects, water quality/ tion. urban toxics and residuals management, water quality/wastewater control technology, water quality/industrial processes, water quality/technical support. Imlustrial processes Water quality/health effects, water quality/ ecological processes and effects, water quallty/ characterization and measurement methods development, water quality/Industrial proc- esses, water quality/monitoring methods and systems, water quality/technical support, water quality/quality assurance. Drinking water Drinking water/health effects, drinking water/ treatment and groundwater protection, drink- ing water/quality assurance. Solid waste Solid waste/control technology, water quallty/ industrial processes. Pesticides Pesticides/health effects, pesticides/ecological processes and effects, pesticides/integrated pest management, pesticides/quality assur- ance. Chemical testing and assess- Toxic substances/health effects, toxic sub- ment. stances/ecological processes and effects, toxic substances/industrial processes, toxic sulk- stances/characterization and measurement methods development, toxic substances/trans- port and fate of pollutants, toxic substances,' technical support. Dr. GAGE. Therefore, what we have effected during this past year is a partnership with our regulatory offices, and we want to enhance our support to them. This worked quite well during our past zero-based budgeting review, and we hope it will be working even more success- fully in the future. In addition, we have taken several other steps which I think will provide a very firm foundation for our planning in the. several time horizons that we must address. PAGENO="0011" 5 First, we have established an interdisciplinary strategic planning and analysis group which addresses a 15- to 20-year time horizon in order to give us the kinds of insight for the 5-year plan. This 5-year plan, entitled the "Research Outlook," has already been submitted to the Congress in typed form. We just got the actual printed proofs of~ yesterday and will be leaving copies of the 5-year plan with this subcommittee. [The following question and answer were submitted for the record;] Question. Addressing the 15 to 20 year time horizon to identify future prob- lems is one aspect of long-term planning. Long-term planning is also appropriate for today's problems as many will be with us for many years to come. Specifically, in an area such as photochemical oxidants, do long-term research plans exist today to provide the necessary Information so that the Administrator of EPA may be in a better position to revise the oxidant standard In 1984 than he was in 1979? What research projects on photochemical oxidants can be l4entified Ill the FY 1980 budget request? (See page 7 of the transcript). Answer. During the past year, the Office of Research and Development ha~ initiated a pilot effort to ensure better coordination between the Agency's re- search program and its regulatory program. Five joint planning and review com- mittees were initiated in the areas of pesticides, drinking water, inhalable par- ticles, mobile source emissions and industrial wastewater research; each com- mittee represented abatement and control, enforcement, regional, and research interests. Each of these bodies reviewed the research program currently being implemented and addressed what new research would be required in the next fe* years to support the regulatory timetable in each area. These committees have been considered quite successful, and we are now moving ahead to Institute similar plannig committees for the remaining portions of the research and d~- velopment program. (A full list of the existing five and newly established seven committees is appended.) One of these new committees will address specifically the research necessary to support the revision of the photochemical oxidant standard. Under t-h~e direc- tion of a chairman from the Office of Research and Development, this committee will examine research both underway and planned on the health effects, environ- mental processes, transport and fate, characterization, monitoring and control Of photochemical oxidants, and propose both the necessary mix and timetable O~ research activities to bring us to 1984 with a more reliable and comprehensive data base than we had In 1979~ Activities proposed in the 1980 budget request for photochemical oxidants include: HEALTH EFFECTS The impact of oxidants on human blood system as well as respiratory functions. Biochemical consequences of repeated human exposure to oxidants. Cellular changes/Immunological changes In humans exposed to oxidants. ECoLoGIcAL EFFECTS Acute and chronic Impacts of oxidants on natural vegetation, agricultural crops and other biological processes with emphasis on alteration of productivity, quality reduction and economic consequences. The impact of urban generated oxidants on San Bernardino, California forest system. The impact of oxiclants In combination with other gaseous air pollutants on terrestrial ecosystem. TRANSPORT AND FATE Smog chamber studies simulating real atmospheric conditions to determine the role of hydrocarbons and nitrogen oxides in producing oxidant pollution will be studied. Air quality simulation modeling (AQSM) focusing on two aspects of the oxidant problem: urban and regional scales. PAGENO="0012" 6 Northeast regional oxidant `study, a major field study being conducted in the northeastern portion of the U.S. to address the problem of long-range regional transport and transformation of oxidants and their precursors. An evaluation of the role of potential natural sources of photochemical oxi- dants. The research will focus on quantifying the role Of natural emissions of hydrocarbons (e.g., terpenes) on producing oxidants in rural areas. Special urban field studies, such asthe Houston project in which 50 percent of the study is devoted to oxidant transport and fate studies. CHARACTERIZATION Studies of volatile organic chemicals industrjes to characterize, quantify and identify those compounds which are contributing to the oxidant problem. CONTROL TECHNOLOGY Continued development and demonstration of the low NOx coal burner. Field testing of combustion modification concepts. Development of energy efficient NO~ control concepts for stationary internal combustion engines and stationary gas turbines. Module title Client program office Water Quality (includes nonpoint sources, areawide planning, modeling, loading prediction, dredge and fill, wa- ter quality criteria, lake restoration). Municipal Wastewater and Spill Pre- vention (includes wastewater, sludge, spill prevention, ocean disposal). Drinking Water. Industrial Processes. Solid Waste. Pesticides. Testing and Assessment. Nonionizing Radiation. Mobile Source Air Pollution. Dr. GAGE. In addition, this past year we made several `large strides in starting up our anticipatory research program, albeit somewhat re- duced because of the budget reduction taken in the Appropriations Committee. We received roughly one-half of the resources that we had asked for, but nonetheless, we did undertake, I think, some quite inno- vative activities in that area. I would like now to review the overall research and development budget by the major functions and to highlight the changes, both in- creases and decreases, as we look at the total program here by function. [Showing of charts. The charts are reproduced below in Dr. Gage's prepared statement.] Office of Water Planning and Standards (OWWM). Office of Water Program Operations (OWWM). Office of Drinking Water (OWWM). Office of Water Planning and Standards (OWWM). Office of Solid Waste (OWWM). Office of Pesticides Programs (OTS). Office of Testing and Evaluation, Office of Program Integration (OTS). Office of Radiation Programs (OANR). Office of Mobile Source Air Pollution Control (OANR). Office of Air Quality Planning and Standards (OANR). Office of Air Quality Planning and Standards (OANR). Office of Air Quality Planning and Standards (OANR). Oxidants (includes NON, ozone, hydro- carbons as precursors). Gaseous and Inhalable Particles (in- cludes ~ suspended particles, lead). Hazardous Air Pollut~tnts (includes hydrocarbons as toxics, metals such as Hg, As, Be, Cd, and asbestos). PAGENO="0013" Dr. GAGE. First of all, the total budget for fiscal year 1980 will be $345.6 million (excluding prorated Agency sup port). This is a net in- crease of $33.2 million over fiscal 1979. The positions available to us for the conduct of this research remain essentially the same for fiscal 1980 as 1979, with a net loss of 1, leaving us 1,751 permanent full-time positions. As you can see, the large increase is in the area of health effects as pointed out in our opening statement, Mr. Chairman. There was an increase of $23.1 million and 47 positions in health effects. While there are increases in other areas, that is the main highlight of the budget ~`presentation. There are, I should hasten to point out, important corol- laries to the increase in health effects which are shown in the ecological effects and transport and fate categories. There is a $1.3 million iii- crease in transport and fate research, Mr. Chairman. These increases are tied very closely to what we are terming our public health research initiative in which we will be looking not only at the effects due to direct exposure of human beings to toxic chemicals in the environ- ment, but also exposure via indirect routes, via the environmental transport, fate and enviromental routes that we in EPA must be par- ticularly concerned with. Mr. AMBRO. Dr. Gage, I wonder if I can just interrupt for a littl~ housekeeping? Dr. GAGE. Please do. Mr. AMBRO. The statement that you have prepared, I would like if there is no objections, to completely make this a part of the record and I would like to suggest that maybe you can have say three-quarters of an hour or an hour so that we could leave another half to three-quarters of an hour for questioning and we can get through the entire process with respect to your testimony today and there will be no need for you to come back tomorrow. If that is acceptable to you and everyone else on the subcommittee I would like to proceed in that way. Is that all right? ~Dr. GAGE. You are giving us a great deal of incentive to move rap- idly, and I will try to keep my remarks as brief as I can. Mr. AMBRO. And then the second bit of housekeeping is that I would like to request that the 5-year plan which you held up be submitted for the committee files. Dr. GAGE. If you will, please. Mr. AMBRO. Without objection, so ordered. [The full prepared statement of Mr. Gage follows:] PAGENO="0014" 8 STATEMENT OF STEPHEN J. GAGE ASSISTANT ADMINISTRATOR FOR RESEARCH AND DEVELOPMENT U.S. ENVIRONMENTAL PROTECTION AGENCY BEFORE THE SUBCOMMITTEE ON NATURAL RESOURCES AND ENVIRONMENT COMMITTEE ON SCIENCE AND TECHNOLOGY HOUSE OF REPRESENTATIVES FEBRUARY 13, 1979 Good morning, Mr. Chairman and members of the Subcommittee. I art happy to meet with you to present the fiscal year 1980 research and development program of the Environmental Protection Agency (EPA). Accompanying me are Dr. William Murray, Acting Deputy Assistant Administrator for Health and Ecological Effects; Dr. Thomas A. Murphy, Deputy Assistant Administrator for Air, Land, and Water Use, and Dr. Courtney Riordan, Associate Deputy Assistant Administrator in that office; Dr. Steven R. Reznek, Acting Deputy Assistant Administrator for Energy, Minerals, and Industry; and Mr. Albert C. Trakowski, Deputy Assistant Administrator for Monitoring and Technical Support. In describing our fiscal 1980 research activities, I will discuss our major programs in turn health effects, ecological effects, trans- port and fate, control technology, monitoring, and anticipatory research, For each program, I will highlight changes in funding and program emphases. First, however, I would like to discuss some management issues, parti- cularly the progress of EPA's research planning and management study, and the public health initiative, which is the focal point of our budget proposal. PAGENO="0015" 9 During this past year, we initiated several actions designed to improve R&D planning and to ensure that our R&D program both supports the Agency's regulatory mission and better prepares the Agency to deal with longer-term problems. The first action was to expand the research committee structure from the five pilots described in our January, 1979 report to the Congress. As that report indicates, the five pilot research planning committees have been successful in developing more coherent regulatory pro- gram/research strategies and improving relationships and communi- cation between the Office of Research and Development and the regulatory offices. Consequently, the five pilot research planning committees are being retained and seven additional committees are being established. Figure 1 displays the planned research committee structure in relation to the regulatory program office organizations. A second initiative is the establishment of an interdisciplinary strategic planning and analysis group to improve the Agency's capa- bility to identify potential future environmental problems. This group is currently developing a long-range environmental forecasting capability. The forecasts produced and analyzed by the group will he used by both the research planning committees and the Anticipatory Research Program to identify future research needs. Our third initiative to improve the Agency's P&D program is focused in the Anticipatory Program area. A program has been estab- lished to encourage innovative, exploratory research by EPA scien- PAGENO="0016" ORD REGULATORY OFFICE COORDINATION OFFICE OF WATER S WASTE MANAGEMENT OFFICE OF AIR, NOISE, AND RADIATION C FIGURE 1 PAGENO="0017" 11 tists, and an institutional support centers program has been developed. I will address this program in more detail later. The aspects of R&D planning addressed above will come together in the development of the next "Research Outlook" report. The strategies produced by the research planning committees, the forecasts and analyses produced by the strategic planning end analysis group, the professional expertise of the chapter (program area) authors, and the results of the exploratory research performed by the Anticipatory Research Program will be integrated into, and help to guide the development of, the overall environmental R&D plan. Collectively, the persons responsible for the separate elements of this report, constitute an agency-wide expert-review panel. In short, in producing the Research Outlook, we will be subjecting our entire R&D program to an intensive review to ensure that it is properly designed to achieve our stated research objectives. Turning now to our budget proposals, I would like briefly to survey the program across the several media categories, then discuss in detail our public health initiative and the major research program categories. Figures 2 and 3 show program changes between FT 79 and 80, by media, in dollars and positions respectively. Our total request for FY 19~O is $345.6 million and 1,751 positions. This a net increase of $33.2 million and a decrease of one position compared to last year's budget. Increases in Air of $18,ROO,000 and 9 positions are for the Public Health Initiative, transport and fate characterization, and monitoring (to accelerate work on measurement techniques for inhalable particulate matter). In Air, five positions were reprogrammed out of Technical Support. 43-718 0 - 79 - 2 PAGENO="0018" TOTAL PROGRAM : Dollars (millions) by media ____________ total 79: 312.4 total 80: 345.6 net+33i AIR WATER DRINKING SOUD PESTICIDES RADIATION 1NTERD1SCIP. TOXICS ENERGY QUAUTY WATER WASTE - FIGURE 2. PAGENO="0019" TOTAL PROGRAM: Positions by media _______________ 600 - total 79: 1752 total 80: 1751 500 - -28 net-i 400 - :~ 200- 5 ~[tLLLLL~[Iii!1[tIi ~ WATER DIUNKINO SOUD ~$TIcIP~& RADIATION INThRDI$ckP. TUXI~$ ENERGY FIGURE 3. PAGENO="0020" 14 In Hater Ouality, the decline of $3,100,000 is the result of increases for wastewater reuse (+$4 million), decreases in some aspects of the ecological program, and the fact that we did not seek the FY 79 SR million add-on for potable water reuse. Eleven positions were reprogrammed from the Technical Support activity to support other activities. In Prinking Water, the substantial increases support the Public Health Initiative as well as increased research on treatment techniques. The Solid Waste program remains level. In pesticides, the funding reduction results primarily from deletion of the FY 79 Congressional add-on of $2.5 million for integrated pest management. The Radiation increases of $900,000 and 3 positions carry forward last year's Congressional add-on of $1 million and add an additional S1 million as part of our health initiative. The interdis- ciplinary category provides a S7.5 million increase for the Anticipatory program balanced against reductions in the funding of the Scientific Assessment and Technical Information programs. Major increases in Toxic Substances of $19,200,000 and 31 positions support our Public Health Initiative, increase ecological effects studies and increase work on toxics transport and fate. Finally, in Energy, we have reductions in work on environmental pollutant control technology as well as in some aspects of the health and ecological effects programs. There are some small offsetting, increases for work on oil shale development, coal liquefaction and gasification. PAGENO="0021" 15 As you can note, there has been considerable reprogramming of personnel across the program with the majority of the new positions going to Toxics and the Air program. These changes were in support of our Public Wealth Initiative, which I would now like to discuss in detail. Public Health Initiative This year we are requesting some ~37 million and have allocated 46 positions to an important new initiative in preventive public health. This request, spanning health effects work in air, drinking water, toxic substances and non-ionizing radiation, as well as a portion of our toxic substances ecological effects program, is the culmination of several forces within and outside the EPA to iniprove the health data base on which costly regulatory decisions are made. The increasing controversy over the high cost of pollution control versus the relative benefits to man of a cleaner environment have caused us to seriously reevaluate the body of knowledge concerning the relationship between health and environmental pollution. Our proposal represents a consensus of Federal Agencies concerned with environmental health problems as to the nature of the gaps in our scientific data base. Last winter, four agencies, EPA, the Food and Drug Administration, the Consumer Product Safety Commission, and the Occupational Safety and Health Administration, founded a voluntary alliance, the Interagency Regulatory Liaison Group (IRLO) to coordinate and jointly plan research. After thorough review, PAGENO="0022" 16 they determined that there were several gaps in their collective research programs and identified three najor foci for new research and development. These are: (1) the development of tests which will allow us to identify quickly and inexpensively those pollutants which are most toxic; (2) the refinement of techniques for conducting human population studies to confirm the results of laboratory tests; and (3) the development of data on the movement of toxic pollutants through the environment which will allow us to better predict the amount of that substance which will reach mao. The IRLC agencies were joined lastJummer by the three institutes which contribute to environmental he~Ith research (National Cancer Institute, National Institute of Occupational Safety and Health, and National Institute of Environmental Health Sciences) in a cross- agency budget exercise directed by the Office of I4anagement and Budget. Extensive discussions amongst these agencies about their research plans and unmet needs reconfirmed the findings of the IRLC Agencies about critical gaps in the Federal research effort. The Public Health Initiative proposals embedded in this year's budget request are EPA's highest priority for new resources. We have redirected substantial dollar and personnel resources within our existing ceiling as evidence of our commitment to this initiative. Figures 4 through ~ summarize the activities in each medium which comprise this new research effort; more detailed descriptions are included in the relevant portions of my testimony, and, of course, in the budget document we have provided to you. PAGENO="0023" FIGURE 4. (,d) = Cu E Cu Cu PUBLIC HEALTH INITIATIVE 15 10 5 - Dollars (millions) ~J Positions 25 20 15 Cu Cu In t~ UI Cu a. 5 PAGENO="0024" PUBLIC HEALTH INITIATIVE AIR QUALITY ($1 5M, 21 POSITIONS) * MAJOR INITIATIVE IN ASSESSMENT OF HUMAN EXPOSURE TO TOXIC AIR POLLUTANTS * NEW MODELS AND METHODS FOR STUDYING IMPAIRMENT OF HUMAN BREATHING AND OTHER EFFECTS * MORE SENSITIVE AND RAPID SCREENING TESTS FOR TOXIC EFFECTS OF AIR POLLUTION * IMPROVED EPIDEMIOLOGI~AL METHODOLOGIES FOR HUMAN POPULATION STUDIES FIGURE 5. PAGENO="0025" PUBUC HEALTH INITIATIVE TOXIC SUBSTANCES ($15M, 16 POSITIONS) - * MAJOR INITIATIVE IN ASSESSMENT F HUMAN EXPOSURE, EITHER DIRECT OR THROUGH. ENVIRONMENTAL PATHWAYS, TO MAN-MADE TOXIC CHEMICALS * IMPROVED PREDICTIVE AND EVALUATIVE METHODS FOR DETERMINING FATE AND EFFECTS OF TOXIC CHEMICALS, BOTH IN HUMAN ORGANS AND IN CRITICAL PORTIONS OF HUMAN FOOD CHAIN * COMPLETION (WITH FDA) OF NATIONAL. NEUROTOXICOLOGIcAL RESEARCH FACiLiTY * MORE SENSITIVE AND RAPID SCREENING TESTS FOR HEALTH EFFEcTS; IMPROVED CHEMICAL MEASUREMENT TECHNIQUES FIGURE 6. PAGENO="0026" PUBLIC HEALTH INITIATIVE DRINKING WATER ($5M, 6 POSITIONS) *IMPROVED EPIDEMIOLOGICAL STUDIES OF POPULATIONS EXPOSED TO MAN-MADE ORGANIC CHEMICAL CONTAMINATION OF DRINKING WATER * EXPANDED TOXICOLOGICAL STUDIES OF ORGANIC CONTAMINANTS NEWLY DISCOVERED IN DRINKING WATER * SUPPUES * IMPROVED SCREENING METHODS FOR CHRONIC EFFECTS ASSOCIATED WiTH DRINKING WATER CONTAMINANTS____ FIGURE 7. PAGENO="0027" PUBLIC HEALTH INITIATIVE NONIONIZING RADIATION ($2M, 3 POSITIONS) * IDENTIFICATION OF THE HUMAN BIOLOGICAL SYSTEMS MOST SENSITIVE TO MICROWAVE RADIATIONS AND THE MECHANISMS OF INTERACTION * EXPANDED EXPOSURE, EPIDEMIOLOGICAL, AND MONITORING STUDIES OF THE GENERAL POPULATION NEAR MICROWAVE SOURCES ________ FIGURE 8. PAGENO="0028" 22 I would like now to describe in some detail the major research ptogram categories in turn. Resource totals for these programs in dollars and positions are given in figures 9 and 10 respectively, indicating major emphases and changes. PAGENO="0029" FIGURE 9. TOTAL PROGRAM : Dollars (millions) by function ______ ________ total 79: 312.4 total 80: 345.6 net 33,2 HEALTH ~COLOG1C~L TRANSPORT MONITORING CONTROl. ANTICIPATORY EFFECTS EFFECTS ~FAT~ Ft TECH SUPPORT TECHNOLOG" PAGENO="0030" FIGURE 10. TOTAL PROGRAM : Positions by~fnction total 79: 1752 total 80: 1751 net-i PAGENO="0031" 25 1~EALT~1 EFFECTS ~PA's research program on the health effects of pollutants is respon- sive to both the implicit and explicit directives of EPA's authorizing legislation to protect public health and welfare. We believe that to be effective in this role, a scientifically valid data base relating adverse research effects to causative pollutant exposures is necessary. Our ability to establish and to measure these relationships is funda- mental to our ability to control pollution and to evaluate our control efforts. As I noted earlier, we are embarking this year upon a major new initiative to protect the public health. The overall theme addresses a systematic, integrated approach which bridges the several media through which human beings are exposed to pollutants and employs the full range of environmental disciplines to predict, measure and assay exposure; to determine the impact and significance of true exposures on human health; and to develop strategies which prevent, interdict or reduce the detrimental effects. The initiative encompasses a total in health effects and related ecological research of $37 million and 46 positions. The overall program in health effects also includes research in air quality, water quality, pesticides, energy, and the interdisci- plinary program areas, and is displayed by figures 11 and 12. Air EPA's air health effects research program identifies pollutants which threaten human health, identifies and quantifies the effects of PAGENO="0032" FIGURE 11. 1.7 c~ HEALTH EFFECTS : Dollars (millions) AIR WATER: DRINKING RADIATION QIJAUTY WATER INTERDIScIP. TOXICS ENERGY PAGENO="0033" FIGURE 12. HEALTH EFFECTS : Positions 240 - +_16 200 160 120 80 ~°: iflIl[Tihiif~1iT1rUL#1L~I AIR WATER DRINKING RADIATION INTERDISCIP. TOXICS ENERGY DUALiTY WATER PAGENO="0034" 28 exposure to those pollutants, and documents the public health benefits of reducing this exposure. Our principal research approaches are toxico- logical, clinical, and epidemiological studies, addressing criteria pollutants, non-criteria pollutants, and pollutants associated with transportation sources. The information developed provides the scientific basis upon which ambient air quality standards are established, maintained, or revised as required by the Clean Air Act Amendments of 1.77. If these standards are not set for harmful air pollutants, or if once set, they are too lax, the health of the public may be adversely affected; if they are too stringent, the economy may be adversely affected by unnecessary costs for pollution control equipment. The fiscal 1980 air health budget is $31.3 million and 213 po~tions, providing an increase of S13.2 million and 16 positions over fiscal 1979. Of the total program, $15 million and 21 positions are components of the Public Health Initiative. The base program includes: 1) animal and human studies on the effects of short-term exposures, and animal studies of effects from long-term exposures, to combinations of criteria pollutants in order to better define the health data base for these pollutants (and therefore, to better determine the adequacy of existing pollutant standards); 2) toxicologic, clinical, and epidemiological studies of the effects of exposure to sulfates, nitrates, metal oxides, and other inhalable particulate pollutants in order to determine which particulate compounds and/or which particle sizes present the greatest PAGENO="0035" 29 hazards and may therefore require regulation; and 3) animal toxicologic studies of the effects of exposure to diesel exhaust, and its components, in order to determine if any of these components pose a potential threat to public health. In support of the Agency's Public Health Initiative, we will improve our capability for exposure measurement and effects measurement. These improved capabilities will be applied in human exposure studies and animal toxicologic studies on genetic, biochemical, and immune responses, and studies to better characterize susceptible human populations and relate studies of these populations to studies of impaired animal systems. We will also conduct population studies on indoor air pollutants, rural and urban dusts, and pollutants near industrial sources. Water Quality Our research on health effects associated with water pollution supports the Agency's efforts under the Clean Water Act to ensure the safe treatment, disposal, and potential reuse of municipal wastewater and sludge. We evaluate the health implications of various technologies and establish health effects data bases for effluent guidelines and water quality criteria. In l9RO, to support the national goal of zero discharge of pollutants, we will increase by $757,000 our research evaluating the potential health effects of ~astewater reuse for industrial and aquacultural purposes. We will begin our studies of industrial reuse with food processing plants. PAGENO="0036" 30 We will also address the health effects of priority toxic organic pollutants. In reviewing the literature on these pollutants we found many areas where little or no information was available. To fill these data gaps, we plan to start studies on ten of these pollutants in 1980. Because the Clean Water Act requires consideration of alternative technologies, we will continue to research health effects associated with the land application of wastewater and sludge. The Act emphasizes studies assessing the potential for harm to man from metals, parasites, and viruses in treated wastes. We will continue also our research on health effects associated with microbial water pollutants to support recreational water quality criteria, and our work on developing rapid screening tests for extrapolating tnutagenesis in short-lived species to man. Drinking Water In the health portion of our drinking water program, we investigate the relationship of hazardous effects to the presence of contaminants in water supplies. Primarily through epidemiological and toxicological studies, we help the Agency determine whether there is a need to regulate given contaminants and if so, to what degree. The results of our studies thus contribute to EPA's efforts to insure that drinking water supplies are as safe as possible. Our public health initiative for FT 80 includes an increase of nearly $5 million and 6 positions over the FY 79 level for health PAGENO="0037" 31 research in this program. These resources will be used to intensify our efforts on the health risks posed by organic, inorganic, and microbiological contaminants. A strong emphasis will be placed on organic compounds and their carcinogenic potential. We will initiate the development of an investigative strategy which will ultimately help to systematically address the numerous organic compounds that have been identified. The outputs of these studies will benefit the regulatory process through, for example, the adaptation of short-term tests for carcinogencity and mutagenicity to drinking water problems. In addition to studies related to cancer, the initiative will expand our program on the relationship of organics, inorganics, and micro- biologicals to the risk of other diseases as well -- cardiovascular disease, neurological disease, and birth defects as examples. We have already expanded our research on the reuse of wastewater for potable purposes to determine the feasibility of establishing criteria for safe reuse. In F? RO, we will continue in this direction. Our plans also call for studies on nitrates. These compounds are found in groundwater and associated with methemoglobinemia. a disorder related to impaired oxygen-carrying capacity of the blood. We intend to continue a series of projects on ingested asbestos and its con- tribution to cancer rates. We will, in addition, sustain a series of projects on microbiological, contaminants. For example, we will investigate the occurrence and transmission of ~~rdia la~~ka, the principal microbiological agent of waterborne disease in this country. PAGENO="0038" 32 We will continue our efforts to improve tests for viral agents thought to be associated with disease outbreaks so that the health significance of viruses in drinking water can be determined. It nay be noted that the microbiological part of this program is coordinated with and provides assistance to the Center for Disease Control in investigating waterborne disease outbreaks. Pesticides The program supports the Agency's pesticides regulatory activities. It includes the development of data required to support administrative reviews and litigation on the major classes of pesticides in common use, and now registered by EPA, and on chemicals considered as possible substitutes for cancelled pesticides. In addition, our research obtains data to permit safety evaluations of the "new generation" pest control agents such as insect viruses, sterility agents, and insect hormones. The program also addresses levels of exposure to pesticides of persons either occupationally or environmentally exposed, and develops standards and protocols for exposure limitations during routine use. We intend to develop analytical chemical methods, for a broader variety of pesticides, that will detect metabolites in human and animal tissues, excreta, air and other environmental media. We will undertake pharmacokinetic studies as guides for the development of predictive mathematical models which can be used to assess human dose/response effects from exposure to selected pesticides. PAGENO="0039" 33 The program studies the potential carcindgenicity of pesticides and particularly the relationship between mutaget~esis and carcino- genesis to reinforce our assessment capabilities. We will explore use of this r.elationship as a short-term screening test method. ~1e will refine animal and cell culture models for assessing potentially carcinogenic pesticides through use of an accepted battery of short- term screening and validation tests. The FY 80 request for pesticides health effects shows a decrease of $112 thousand, reflecting a reduced emphasis on predictive modeling. The remainder of the program will be continued at the FY 79 level. Radiation The radiation research program focuses on the potential biological effects of human exposure to non-ionizing electromagnetic radiation from environmental sources with emphasis on chronic, low-level exposures. Additionally, we are studying the mechanisms of inter- action of electromagnetic radiation, including frequency dependence, with biological and biochemical systems. The health effects being investigated include neurophysiologic, behavioral, immunologic, teratologic and mutagenic responses. The fiscal 1980 budget has a net increase of $960,000 and 3 positions in this area. This results from carrying forward the FY 1979 add-on (Si million) and providing an additional $960,000 and 3 position increase to support the public health initiative. PAGENO="0040" 34 The public health initiative will provide a more stable funding environment in which to conduct long-term studies. These will include animal studies which can be used as potential indicators of human health effects. Epidemiologic studies are being conducted to complement these toxicological investigations. These population studies could not be accomplished without this initiative. We also are expanding our capability for monitoring and assessing the possible health effects of the ambient radio frequency environment to which the general public is exposed. Interdisciplinary - Scientific Assessment The scientific assessment activity is a relatively new program which incorporates both existing health and environmental assessment functions and several new initiatives for 1979 and 1980. The program provides the EPA's regulatcry offices with a centralized capability for evaluating information on health and ecological effects from exposure to pollutants and estimating the level of health risk involved. The program reviews known information about pollutant effects, interprets this information, and produces scientific data summaries for subsequent risk assessment or other regulatory decision making. The hazard assessment portion of the program is responsible for maintaining consistency and quality among the risk assessments prepared throughout the Agency. To insure this, the program establishes Agency-wide guidelines and reviews completed assessments. In certain media, the program itself conducts risk PAGENO="0041" 35 assessments and prepared criteria documents. Typical outputs from the scientific assessment program include: reviews, guidelines (including guidelines on exposure assessment), health criteria documents, aquatic effects criteria documents, health assessments, reports on special health/exposure situations and both preliminary and full risk assessments dealing with carcinogenic potential, as well as a new initiative dealing with mutagenic effects. The funding of the scientific assessment program decreases by S2.6 million, following completion of Consent Decree water quality criteria documents, whereas staffing is increased by 8 positions to support the Agency in its need for risk assessments and provide the new capabilities required. Toxic Substances The toxic substances health effects research program focuses on pollutant screening tests to support the requirements of the Toxic Substances Control Act (TSCA). Specifically, the program is oriented toward ensuring that adequate methodologies and data are available to implement the regulatory and testing elements of the Act. The fiscal 1980 budget provides an increase of $7.4 million and 14 positions, of which $6.0 million and 6 positions will support the Agency's public health initiative. This toxics portion of the initiative provides an integrated approach to assessing human exposure and subsec~uent health effects of toxic chemicals. It will enable rapid PAGENO="0042" 36 expansion of the development of screening techniques for prediction of neurotoxicological effects, and it will also provide new studies for determining the relationship between the absorbed dose of toxic substances and the impact of this exposure on humans. The remainder of the increase will be in the base program, for research studies which will provide a better understanding of carcino- genic processes, screening techniques and regulatory testing protocols that predict toxicant effects. In our base program we will emphasize epidemiological methods development, the validation of protocols for study of human sterilants, screening methods for industrial chemicals, and development of analytical chemical methods for assessment of human exposure. There is also a $130 thousand increase for research to evaluate health implications, such as skin cancer, thought to be caused by increased solar ultraviolet (TJV) exposure (resulting from depletion of the stratospheric ozone layer). We will carry on our UV monitoring network and start new studies on the health impacts of increased radiation. Energy The energy-related health effects research program identifies the long-term adverse impacts that can ensue from increased domestic energy development and use. Of major concern are those health effects that may occur as a consequence of long-term, low-level exposures and that PAGENO="0043" 37 manifest themselves only after long periods of time cancer, birth defects, and cardiopulnonary system disorders. The necessary data are obtained through a coordinated program of clinical, epideniological, and toxicological studies undertaken by EPA, the T)epartnent of Energy, the National Institute for Environmental F~ealth Sciences, and the National Institute for Occupational Safety and Health under the Inter- agency Energy/Environment Program. The fiscall980 budget provides a decrease of $1.7 million below the fiscal 1979 level. This reduction reflects the completion in fiscal 1979 of several projects dealing with exposures to oxides of sulfur and nitrogen. PAGENO="0044" 38 ~~QLOGICAL EFFECTS As with our research efforts devoted to the effects of pollutants on human health, EPA is also responsible for conducting research related to their ecological effects. These two programs are coriple- mentary in that the ecological effects research is concerned with the extent to which environmental pollution damages the structure, function and dynamics of freshwater, marine and terrestrial ecosystems (includ- ing stratospheric modifications); the degree to which these eco- systems can recover from pollutant stress; and the effects on human health resulting from the altered or damaged ecosystems. Within the ecological effects program, we are also supporting the public health initiative through efforts designed to advance the state-of-the-art in defining and predicting the effects upon humans from exposures to toxic chemicals which are released or escape into the environment. Outputs from this program are used in developing water quality standards, effluent guidelines for toxic and hazardous materials, ocean discharge criteria, secondary air quality standards, and dose response relationships for pesticides and other toxicants. Figures 13 and 14 summarize resource level changes by media. Air The major goal of the air ecological effects research program is to protect the terrestrial ecosystem for the benefit of man. Con- sequently, this program focuses upon the effects of air pollutants on PAGENO="0045" ECOLOGICAL EFFECTS: Dollars (millions) 15 10 20 2A 1.4 5 AIR WATER TOXICS. ENERGY QUAUTY FIGURE 13. PAGENO="0046" FIGURE 14. ECOLOGICAL EFFECTS: Positions 240 200 -15 160 120 80 40 +11 _________ il__u_Il - AIR WATER TOXICS ENERGY 79 80 (IUAUTY PAGENO="0047" 41 the structure and functions of the flora, fauna and soil, components of the ecosystem, particularly on economically significant agricultural and forest plants. It provides the scientific basis upon which to establish and continually evaluate secondary ambient air quality standards. The fiscal 1980 budget provides an increase of $727,000 for this program. The increase expands the extramural activities to assess the effects of gaseous airborne pollutants, and investigate the impact of selected non-criteria pollutants. We will maintain emphasis on the study of sulfur dioxide, ozone and nitrogen oxides, and their longer-term effects at low levels and in various combinations, and complete our analysis of the effects of photo-chemical oxidants on the San Bernardino Forest. This project will provide significant information for developing and strengthening air quality control strategies. Other laboratory and field studies will determine the impact on productivity, quality alteration and economic losses associated with pollutant exposure and will generate predictive models for forecasts of future pollutant impact. Research on non-criteria pollutants such as halogen gases, heavy metals and particulates will include evaluations of their potential bioaccumulation and their essential impacts on biological and/or physiological processes. Investigations will assess, where applicable, methods which will alleviate extreme damage to floral, faunal and soil systems. PAGENO="0048" 42 A critical part of the air ecological effects research program is to relate these effects to the important pathways, such as food- chains, leading to man. Water Quality The water quality ecological effects program is designed to determine the effects of pollutants in freshwater and marine ecosystems. This program contains four major research categories: freshwater and marine ecological effects, the Great Lakes, and the Chesapeake Bay. The freshwater ecological effects research program resources for fiscal 1980 are decreased by $1,116,800 and 11 positions. The decrease of 11 positions eliminates the cold climate research effort, and significantly reduces the Clean Lakes demonstration program. Research on the ecological assessment of the land appli- cation of wastewater and sludge will also be curtailed. The freshwater ecological effects program will focus primarily on environmental exposure assessment, which includes ecological effects and human food chain analyses; methods development in environmental toxicology; and the characterization of pollutants. We will identify and attempt to fill research data gaps for the 129 Consent Decree chemicals in support of the effort of the Agency to prepare Water Quality Criteria documents to comply with the Court's Consent Decree. PAGENO="0049" 43 The resources allocated for the fiscal 1980 Great Lakes program are decreased by $2,000,000 from fiscal 1979. This decrease is the result of the $1,500,000 Congressional add-on in fiscal 1979 which is not being carried forward and $500,000 reduction in the base pro- gram. It will reduce the work effort in the areas of eutrophication, hazardous materials and fundamental processes of pollutant transfer, accumulation, fate and effects. The fiscal 1980 budget for marine ecological effects has an increase of $282,000 which is devoted to ocean outfall research, and a four-position decrease related to the development of criteria for polluted sediments, the impact of urban storm water runoff on estuaries, and the movement of pollutants from sediments contami- nated by waste disposal activities. The program will continue to emphasize research on the development and validation of techniques to determine the effects of pollutants, to address questions of productivity and function of wetlands, and to focus on ocean dump- ing problems related to disposal of dredged materials. The Chesapeake Bay Program will receive an additional $500,000 to emphasize a continued program of integrated study in the areas of toxics management, eutrophication and submerged aquatic vegetation and the initiation of a program with other Agencies to evaluate water quality problems induced by dredging and spill disposal and various hydrological modifications. 43.778 0 - 79 . 4 PAGENO="0050" 44 Pesticides The pesticides ecological effects research program emphasizes assistance to the Agency in the registration/reregistration of pest control agents and in the formulation of policies involving the registration process. Our work deals with marine, freshwater and terrestrial organisms, and embraces the multiplicity of effects of commonly used pesticides and their metabolites. Included also are new generation pesticides and substitute pesticide chemicals which may be used in place of those whose use has been limited or banned. The research concentrates on development, standardization, and validation of an array of methods for assessing environmental exposure and effects of pesticides. In fiscal 1980, the program will be reduced by $82,000, re- flecting a decrease in funding for analytical services in support of effects and residue studies. The remainder of the program will be supported at the fiscal 1979 level. Toxic Substances The toxic substances ecological effects program presently empha-' sizes development of accurate procedures for screening chemical sub- stances to provide the scientific basis for decision-making regarding safety and acceptability of chemicals in the environment. A variety of tests for marine, freshwater and terrestrial organisms and communi- ties are under development to examine toxic and sub-lethal effects on growth and development. Validation and calibration of new, as well as existing procedures, are emphasized. PAGENO="0051" 45 An increase of $9,000,000 and ten positions is added to this program to support the public health initiative. This new work is oriented toward human exposure to toxics from the environment and deals with the role and movement of envirotunental toxics toward man. The resources will be used to implement an integrated program of lab- oratory and field studies aimed at providing an array of screening tests, models, monitoring approaches, and data bases which can be used to predict human exposures to substances once they are released to the environment. We will expand studies of the effects of increased ultraviolet (UV) radiation reaching earth (as a result of stratospheric ozone depletion) with an additional $104,000 to improve our understanding of ecological and climate effects of ozone depletion. The program will deal with field crop sensitivity and UV effects on photosynthesis. Damage to these systems would be a direct threat to mankind's food production. Energy /Eco The energy-related ecological effects program determines the effects of present and proposed energy development and use activities on freshwater, surface water and groundwater, marine and estuarine environments, and atmospheric and terrestrial organisms and eco- systems. The program includes research on the effects of coal and oil shale extraction on terrestrial and aquatic ecosystems; the ef- fects on marine and estuarine environments of oil and gas exploration PAGENO="0052" 46 and production; and the effects on rivers, lakes, and ponds of runoff or leachate from coal stockpiles and mining wastes, as well as of rainout of fuel combustion emissions. The fiscal 1980 budget provides a $1.4 million decrease from the 1979 level. This reduction reflects completion in fiscal 1979 of several projects dealing with long-term effects of hydrocarbons in the marine ecosyster~s, and trace contaminant effects in freshwater and terrestrial systems. PAGENO="0053" 47 TRANSPORT MID FATE The transport and fate research program develops analytical and empirical techniques relating pollution emissions to ambient exposure levels. We examine the biological, chemical, and physical phenomena affecting pollutants as they migrate from source to receptor, and determine their ultimate fate in the environment. This provides the basis for translating ambient environmental quality goals into pollutant control requirements at the source. This research also provides major input to our health effects research effort. because of the chemical/physical transformation process which occurs in the natural environment, the actual agent causing health impacts may be different than would be suspected from identifying emissions and discharges at their source. The transport and fate program is targeted to atmospheric, aquatic, and terrestrial pollutants, with activities in the air, water quality, toxics and energy media. Figures 15 and 16 highlight resource changes by media. Air The air transport and fate program identifies the sources, formation, transformation, removal processes, and ultimate repositories for airborne gaseous and particulate pollutants. Using the data developed on these basic processes, we develop air quality simulation models which predict ambient exposure levels under various conditions and regulatory strategies. PAGENO="0054" FIGURE 15. TRANSPORT 8 FATE: Dollars (millions) 30 25 20 15 +2.1 `: ~ ____ +0.4 1!~ ___ AIR TOXI~S ENERGY PAGENO="0055" FIGURE 16. TRANSPORT & FATE: Positions 240 120 AIR TOES ENERGY PAGENO="0056" 50 The fiscal 1980 budget provides an increase of $2 million. This increase will primarily support special studies to predict pollutant concentrations over complex or rough terrain. Also, we will continue to investigate the long-range oxidant transport phenomenon, study the role of man-made and natural sources of oxidants and hydrocarbons (oxidant precursors) and use smog chambers to simulate the photo- chemistry of oxidant formation in urban and rural atmospheric conditions. Work will be conducted on inhalable particulate matter, including sulfates and nitrates, to determine their spatial and temporal concentrations in the air environment, their sources and sinks, and their contribution to deteriorating visibility in various urban areas in the United States. Water Ouality EPA's water quality transport and fate program provides methods and data to predict water quality impacts resulting from the discharge of point and nonpoint source pollution into fresh surface waters, to determine maximum allowable loadings of pollutants to a given water body segment, and to evaluate the costs and benefits of alternative management strategies. We emphasize developing procedures and mathe- matical models for area-wide or basin-wide assessment of water quality problems and pollution management strategies. EPA Regional Offices and State and local planning and pollution control agencies use the outputs of the program to prepare water quality management plans for achieving and maintaining desired water quality goals in the most cost-effective manner as required by the PAGENO="0057" 51 Clean Water Act. These methods and data also assist in the identi- fication of both water quality limited stream segments and appropriate effluent limitations to be stipulated in National Pollutant Discharge Elinination System permits. The proposed 1980 budget provides an increase of $78,500 and one position for acceleration of the expansion of existing models to address selected toxic chemicals of interest to the Office of Water and Waste Management. Toxic Substances EPA's toxic substances transport and fate program is designed both to characterize environmental processes which transform toxic chemicals and to determine the ultimate fate of these substances in the environment. The 1980 budget provides an increase of $416 thousand and 2 positions for the characterization of environmental processes that control the transport and transformation of toxic substances in soils and sediments and for development of an environmental forecasting system to predict potential environmental problems associated with toxic substances in multimedia environments. Expansion of the research efforts in this area will substantially enhance our support of the Office of Toxic Substances. This support consists primarily of providing the methods and related data for assessing human and environmental risks associated with the production, use, and disposal of toxic substances, an essential step in their regulation. PAGENO="0058" 52 Energy The energy-related transport and fate program identifies the physical and chemical changes in pollutants from energy sources as they move through air, water and soil to accumulate in the environment and to expose man. The goals of the program are to identify the sources and characterize emissions of pollutants into the air, water and soil from both conventional and advanced energy technologies, such as coal liquefaction and gasification, oil shale extraction, and geothermal energy development. Also included in the program is the determination of the rates and mechanisms of transformation of primary pollutants into secondary pollutants by means of their interaction with ambient air, water vapor, rain, ice, and through solar irradiation. The fiscal 1980 budget provides a $1.2 million decrease below last year's level. This reduction reflects completion in fiscal 1979 of projects dealing with development of remote sensing techniques for studying the transport and transformation of secondary pollutants in the atmosphere. PAGENO="0059" 53 MONJTORING AND TECHNICAL S1JPPQ~ In administering Federal environmental legislation, EPA requires reliable, quantitative information on the extent, concentration and trends of environmental pollution. This information is obtained through environmental monitoring. ORD's research programs, in support of the monitoring requirements of the Agency, provide information and technology used to determine how pollution parameters and pollutants can be accurately identified, measured and monitored. T~PA's monitoring research program has as its primary goals the development of measurement methods, the demonstration and evaluation of monitoring systems under field conditions, the provision of quality assurance tools to assure the accuracy of data which is used for regulatory purposes, and the provision of technical support to the regional and program offices. Figures 17 and 18 detail changes in the program's resource level. Air The Agency's Air Monitoring and Technical Support Program includes characterization and measurement methods development, monitoring~ systems development, quality assurance and technical support. The 1980 budget for the Air Characterization and Methods Develop ment Program provides an increase of ~2.4 million. Most of this increase reflects a planned acceleration of work being undertaken on carbon fibers in 1979. In addition, a portion of the increase will PAGENO="0060" MONITORING ~ TECHNICAL SUPPORT: Dollars (millions) 30 25 + 32 20~ J Oi +1.2 10 5: ~ ~fr-~~LJrn AIR WATER DRINKING INTERDISCIP. GUAUTY WATER FIGURE 17. PAGENO="0061" FIGURE 18. MONITORING Et TECHNICAL SUPPORT: Positions 240 200 160 -11 120 - 80 40 FT7 AIR WATER DRINKING INTERDISCIP. QUALITY WATER PAGENO="0062" 56 be used in characterizing the inhalable particulate matter emitted from sources, and in determining, through field studies, how various particulate sources have an impact on ambient air quality. The remainder will be used to expand work on characterizing organics in various localities and developing sampling methods for these potentially hazardous substances. The total increase of $866,000 for Monitoring Methods and Systems and Ouality Assurance reflects continued growth and expansion of systems for monitoring inhalable particulates, for augmenting research to improve air monitoring networks, and to provide for additional support for on site evaluation and data audits of the State, local and National Air Monitoring Stations and for the Enhalable Particulate Network. The Technical Support Program will be decreased by approximately ~112,O00 and five positions to accommodate shifting priorities in the air monitoring program.. In 1980, this program will focus on provision of support services to the Office of Air Quality Planning and Standards and the Office of Enforcement. Water Quality EPA's Water Quality Monitoring and Technical Support program encompasses characterization and methods development research, moni- toring systems development, quality assurance and technical support. Our fiscal 1980 budget for this program provides for a net increase of $1.199 million and a net decrease of 11 positions. PAGENO="0063" 57 $864,100 of the increase of $1.2 million and one additional posi tion will be applied to our characterization and methods development activity. Of the $864,100, $500,000 will be devoted to the development of much more cost effective measurement techniques for organic chemicals in water and wastewaters. The remainder of the increase ($364,000 and one position) will be used to accelerate our assistence to the Office of Water and Waste Management in the identification of toxic organic chemicals commonly present in industrial effluents. The decrease of $913,000 for Monitoring Methods and Systems reflects a reduction in the effort for development of new field monitoring methods for toxic pollutants in this fiscal year as portions of this work are phased to completion. The increase of $1,210,000 for Quality Assurance, coupled with a one position decrease, will be used to assure the validity of priority pollutant measurements with greater reliance on contractors for work performance. The Technical Support Program will be decreased by eleven positions. This results from a focusing of this support effort on the Agency's spill prevention attd countermeasures program and a transfer of the remaining positions to other, higher priority program areas. Drinkiflg Water The Drinking Water Quality Assurance program focuses on supporting the Agency's Drinking Water Program through provision of standard reference materials, standardization of monitoring methods, the PAGENO="0064" 58 development of quality control procedures and manuals, the conduct of laboratory performance tests, and the development of criteria and procedures for certifying laboratories, and test and evaluation of equivalent analytical methods. Our 1980 request reflects a reduction of ~265,0O0 and 7 positions (as initial efforts on laboratory certification procedures have been completed and implemented). Pesticides The pesticides Quality Assurance program serves to document the quality of physical, chemical and biological pesticides data in terms of precision and accuracy. Our fiscal l~8O budget for this program provides for an increase of ~27,6OO and 1 position to initiate development of a repository of reference materials for use by biological testing laboratories. In addition, the increase will support a refinement of quality assurance procedures for these same laboratories. Toxic Substances The Toxic Substances monitoring program improves analytical methods, instrumentation, and sample collection and separation. It provides ways to identify, quantify, and monitor toxic chemicals in air, water and soil. The main components of this program are characterization and measurement methods development, and technical support. The fiscal 1980 budget request for this program reflects an increase of $512 thousand. Of this increase, $46 thousand will be PAGENO="0065" 59 used to initiate development of measurement methods for toxic chemicals in sediments, and ~466 thousand will be used to provide additional technical support to the Agency to identify and document the nature and extent of the toxic burden in the environment. As in F! 1Q79, our first priority will continue to he assisting the Agency's Office of Toxic Substances in determining the presence and concentration to toxic compounds. Energy The energy-related monitoring program is directed toward identifying and quantifying ambient pollutants associated with expanding energy development and developing associated pollutant measurement capabilities for both air and water. The two major goals of the program are to establish an adequate air and water quality data base in areas undergoing rapid energy resource development and to develop validated sampling and analytical methods to detect and measure energy-related pollutants at environmental levels. The fiscal 1980 budget provides a $272,000 increase over the fiscal 1979 level. This increase will be used to expand the quality assurance and air monitoring support activities for areas of the ~`idwest and Eastern United States. Technical Information The mission of the technical informaticn and technology transfer program is to assure the effective dissemination of the products of 43-778 0 - 79 - 5 PAGENO="0066" 60 the Agency's research and development programs to users within the Agency and throughout the public and private sectors. This activity includes the publication and general distribution of EPA's scientific and technical reports, response to requests for specific information on our programs, and information transfer wherein available information, n~aterials or technology is matched to the needs of officials who frequently do. not possess a technical or scientific background. Specialized publications and symposia are also developed to be most useful and readily understandable to the targeted user. The program also provides coordination and support for such Congressionally mandated efforts as the Small Wastewater Flows Information Clearing- house and the annual EPA Research Outlook (Five-year Plan). The fiscal l9$O budget request for this area incorporates a decrease of some $900 thousand and 7 positions from the 1979 level. In the future, only the resources necessary to maintain policy coordination and quality control, along with those information support activities which are most effectively and efficiently managed on a centralized basis, will be identified within this budget category. Funding will be drawn from the programs to which the work is most closely aligned. PAGENO="0067" 61 CONTROL~ TEC}ThTQLOGY Research on control technology and techniques is conducted in the industrial, urban or "public sector," and energy program areas. The energy portion of the program assesses the potential for environS. mental insult associated with conventional as well as emerging energy technologies. This program evaluates the degree of control needed to reduce the potential impact and assesses costs associated with various pollution abatement technologies. Results of this research are utilized by the Agency's regulatory program to develop standards of performance, Effluent (uidelines, and waste disposal practices for activities concerned with energy production. The information obtained is also used by the private and public sector to expand the use of coal while minimizing associated environmental insults. The industrial component develops and evaluates technologies to reduce pollution from manufacturing, agricultural and service industries, and from the extraction and processing of non-energy-.related raw materials. We place high priority on the elimination or control o~ toxic pollutants and on devising ways to reuse wastewater for industrial purposes. Through this program, we develop ways to reduce the release of pollutants from both point, and nonpoint area'-.wide, sources and to control spills of hazardous materials. The results of this research also support the development of New Source Performance Standards and Effluent (uidelines. PAGENO="0068" 62 The third component of the Control Technology program, the urban or "public sector" research area, develops technology to improve municipal wastewater treatment systems, determines suitable means of managing urban runoff, develops technology to disinfect or decontaminate drinking water supplies and develops technology for solid and hazardous waste disposal. These activities support the Agency's strategy for achieving the goals of the Clean Uater Act, and EPA's regulatory efforts under the Safe Drinking water and Resource Conservation and Recovery Acts. Figures 19 and 20 in- dicate resource level changes for the Control Technology program. Air The air Control Technology program is executed primarily as an extramural effort responsive to legislative mandates of the Clean Air Act. Our objective is to develop and demonstrate pollution con- trol technologies capable of reducing or eliminating potentially hazardous air pollutant emissions from industrial point sources. The program provides technical and cost information to the regula- tory offices of the Agency. The program focuses on a few critical emissions known to have detrimental effects on human health and the environment ~- such as hydrocarbon emissions which are precursors to oxidant formation. Also, to accelerate acceptance of new technology, we demonstrate applicability of techniques such as surfactant enhanced scrubbing to control emissions from the automotive industry. The reduction of two positions and $481,000 will result in decreased emphasis on developing data for new source performance standards and assisting EPA regional offices to evaluate new source permit applications. PAGENO="0069" FIGURE 19. CONTROL TECHNOLOGY : Dollars (millions) 5 ioxics ENERGY AIR WATER QUALITY PAGENO="0070" CONTROL TECHNOLOGY: Positions -3 NH +4 -.9 WATER DRINKING QUAUTY WATER FIGURE 20. PES11~IDES TXIS ENERGY PAGENO="0071" 65 Water 0ual~ The industrial research program encompasses development and demonstration of new or improved, cost-effective technologies and practical management systems for industrial, agricultural, and silvicultural production activities. As a result of the EPA/Natural Resources Defense Council Consent Decree in June 1976, and the 1977 Amendments to the Clean Water Act, we have shifted the current industrial program emphasis toward developing the data required to regulate the discharge of toxic pollutants. The new program direction focuses on developing complete waste stream assessments, which include chemical and bioassay data, and on developing treatment alternatives for industrial waste efflu-' ants. tn addition, this program develops technology for the preven- tion and control of accidental spills of hazardous materials. In FY 80, we will continue our efforts on optimizing currently available treatment methods and on developing innovative technologies to reduce the level of, destroy or beneficially reuse pollutants. Outputs will contribute to revisions of the effluent guidelines. The PY 80 budget request for industrial control technology reflects a S4.2 million increase over the 1979 level. The funds will be used to establish a major program to demonstrate reuse and recycle PAGENO="0072" 66 options for industrial wastewater discharges. We will concentrate specifically on three of the 21 industries suspected of contributing a high number of the 129 priority pollutants in their discharges. This effort will incorporate existing treatment methods and new technology in demonstrations of reuse and recycle systems for the selected industries and will result in widely applicable benefits such as: (1) reduction of wastewater volume, (2) reduction of intake water, (3) cost and energy savings, (4) conservation of water and other natural resources, (5) containment of conventional and toxic pollutants, and (6) progress towards the national goal of "zero discharge of pollutants." An important part of the effort will involve addressing ways in which to minimize impacts from the waste- water pollution abatement practices themselves. Such impacts will include those on energy consumption, air quality, and land. That part of the water quality program devoted to the agricultural industry supports research on agricultural activities with respect to their point and nonpoint contribution to area-wide pollution. The activities covered include animal production, irrigated and non- irrigated crop production, and forestry. Sufficient progress has been made on the development of methodology to assess nonpoint source loading to begin a field evaluation effort. The series of projects will test the applicability of water quality planning tools which we have developed for selecting Best ~anagement Practices (BMP's). The ultimate objective is to demonstrate their usefulness to achieving water quality goals in a cost-effective way. PAGENO="0073" 67 As noted earlier, our Control Technology program also addresses pollution problems assooiated with urban or "public sector" kinds of activities -- treatment and disposal of municipal wastewater, provi- sion of safe drinking water, and disposal of solid waste and hazardous materials. En the municipal area, we develop and demonstrate technology for treating and disposing of wastewater and sludge. We ~till continue to develop new treatment processes which are efficient, reliable, energy conservative, and economical. As is now the case, our main focus will be on sludge disposal and toxics control. Our FY 80 request provides for an increase of $1,250,000. A total of $650,000 will be used for limited evaluations of innovative sludge disposal technologies built with construction grants. The evaluations will study technolo- gies which offer reduced costs and beneficial uses of sludge. The remaining $600,000 increase will allow for grants to support excessive operations and maintenance costs for certain demonstration projects previously funded by OPD. We will also be expanding efforts on data collection on the levels of toxics which may be in municipal wastewaters. This informa- tion will help in other studies underway which involve identifying and solving pretreatment and combined treatment problems. Our ultimate goal is to improve the design and operation of treatment plants so that the presence of toxic substances can be minimized. PAGENO="0074" 68 Drinking Water The drinking water research program provides methods for identify- ing and measuring contaminants in drinking water and develops, evaluates, and improves the control technology necessary for achieving drinking water standards at reasonable cost. We also perform research to establish a scientific base for regulatory decisions to protect sources of drinking water. Our research on treatment methods concentrates on organics with emphasis on full-scale treatment processes. In addition, we work on methods to control inorganics, particulates and microbiological con- taminants with attention to treatment costs. Distribution sys~em effects on inorganic and microbiological quality of drinking water are also studied. In the groundwater protection research area, efforts are di- rected toward providing a data base for regulatory decisions to protect aquifers from pollution. Central to this effort is research devoted to understanding the movement of viruses and organics in the underground environment and guidance for control of pollutant sources. In FY 80, a $1 million increase is provided to continue a program initiated in FY 79 on reuse of wastewater for potable purposes. The program's objective is to examine and demonstrate the feasibility of modifying existing wastewater renovation plants. This research, coupled with an effort on means for conserving municipal water use, will form the technical basis to support Agency policy on water con- servation amd, in turm, support national policy on water resources. PAGENO="0075" 69 Solid Waste The purpose of the solid waste research program is to insure that there are adequate environmentally sound practices for solid and hazardous waste disposal to prevent air and water pollution, eliminate hazards to health, and conserve land and other natural resources. To this purpose, the research supports the Agency's strategy for achieving the goals of the Resource Conservation and Recovery Act of 1976 (RCRA). Included in the program is the assess~ ment of emerging technologies for: (1) improving land disposal practices for solid and hazardous wastes; (2) reducing the harmful environmental effects of inactive or existing unsound landfills, and of hazardous material spills; (3) alternatives to land disposal; (4) the destruction of hazardous wastes or the rendering of such waste environmentally safe; and (5) the production and recovery of usable resources from solid waste. In addition, the program generates data which are necessary to support Agency regulations, criteria and guidelines mandated by RCRA. The regulatory responsibilities contained in RCRA relating to hazardous wastes caused our research direction to begin a redirec- tion in F! 1978 from municipal solid wastes to hazardous wastes. Today, about 80 percent of the program addresses the problems of hazardous wastes. Seginning in F! 1979, additional research effort was initiated in the area of hazardous industrial wastes, as opposed to hazardous wastes which enter the municipal waste stream. That shift has been sustained in FT 1980 so that approximately $2 million PAGENO="0076" 70 of an $8 million program will be directed to solutions for industrial hazardous waste problems. We are directly addressing the problem areas identified by the Agency's Office of Solid Waste and aim to provide the analytical methods, remedial technology and management capability needed to prevent future catastrophies such as the Love Canal, and to correct the problems of past poor management practices of hazardous waste. Pesticides The Integrated Pest Management (1PM) program supports studies which develop information on the biological and ecological inter- actions among pests, crops, and man, leading to alternate pest management strategies with reduced usage of pesticide chemicals. 1PM techniques are applicable not only in agricultural production but also in urban environments. Among the cost-effective 1PM tech- niques developed are the use of biological controls (e.g., insect and weed disease organisms), chemical attractants and lures, and chemicals which disrupt the normal maturation or reproductive cycles of the pests. Also of significant value has been the development of accurate, on-farm information by field-scouting for use in con- junction with predictive models for pest control decision making. Until recently, the 1PM program concentrated on single insect pests and single crop ecosystems. In cotton and apple ecosystems, for example, we have achieved field applied practices for eco- nomically controlling certain insects, with substantial reduction in chemical pesticide use. The emphasis of the program has been PAGENO="0077" 71 changed, and more attention is being directed to investigating both weeds and insect pests in multiple crop ecosystems, to study~ ing urban pests such as tree, turf, and household pests, and to accelerating the transfer of 1PM strategies to the user community. We have established coordination with the U.S. Department of Agri- culture (USDA) components involved in 1PM research and implementation to assure that our resources are used effectively. The USDA is seeking additional funds for this purpose in FY 80. The program will experience a reduction of $2.8 million in FT 1980, reflect discontinuance of the FT 1979 Congressional add-on for 1PM ($2,500,000), and a reduction of $300,000 in the base program. Toxic Substanc~S~ The toxic substances industrial research program, now in its second year, supports directly the current needs of the Office of Toxic Substances (OTS). It provides (1) technical assistance to identify and quantify toxic chemicals in industrial manufacturing processes and products; (2) evaluations of process alternatives in terms of environmental acceptability based on toxic pollutant cri- teria; (3) definition of the occurrence of toxic substances as impurities in commercially available chemicals; and (4) information on the availability of substitute chemicals to replace those for which TSCA mandates decreased consumption. PAGENO="0078" 72 FY 1980 activities will increase by $1,290,000 and four posi- tions. This supports: (1) assessments of alternative processing routes and in-process modifications required to minimize production of toxic contaminants in chemical feedstocks, intermediates, and products, and (2) development of a "new" chemical manufacture pre- dictive model based on the unit process approach. The energy Control Technology program will, in accordance with the President's Environmental Message and the National Energy Plan, allow for the expanded use of coal while minimizing its adverse environmental impacts. This program includes control technology assessment and control technology development for conventional combustion processes and emerging energy technologies. The research and assessment activities in the former area encompass evaluation of flue gas desulfurization (FGD) processes, nitrogen oxides (NOx) control technology development, control of fine particulate emissions, and the assessment of the socio-econornic-environmental impacts of expanded use of coal in conventional combustion processes. Control technology research and environmental assessment of emerging energy technologies includes the study of fluidized bed combustion (FBC), oil-shale processing and coal liquefaction and coal gasification processes. PAGENO="0079" 73 As a result of our zero-based budget analysis, the energy Control Technology program decreases by $5,500,000. The sulfur dioxide control program, the assessment of non-criteria polluta~ts from conventional combustion, development of wastes-as-fuel tech- nology, and the environmental assessment of tar sands processing will be curtailed. Partly balancing this reduction, the Department of Energy (DOE) will expand its funding for energy-related environ- mental control technology for conventional combustion processes in fiscal 1980. EPA will participate in the planning, review and implementation of the DOE program. We will continue to pursue the existing NOx control technology to its conclusion, but the remaining technology program will shift emphasis to bench scale research and control technology assessments. During fiscal 1980 we will continue the low NOx coal burner development and demonstration program for industrial and utility boiler applications. The evaluation of flue gas desulfurization processes is being curtailed and the program is shifting to assess- ing the status of inplace processes and overseeing DOE's flue gas desulfurization program. The fine particulate control program will emphasize the development of inhalable particulate matter emission factors to support EPA's Office of Air, Noise and Radiation. Waste- as-fuel R&D will be limited to the highest priority problems identi- fied by DOE. Efforts to identify the environmental threats posed by unregulated emissions from cor~ventional combustion will also be limited. PAGENO="0080" 74 In the emerging energy control technology development and envi.. ronmental assessment program, we will continue to emphasize the characterization of effluents and emissions, the assessment of related environnental impacts, and the evaluation of necessary pollution control technology for various synthetic fuel processes. The results of this effort are used as input to the Agency's stand.. ard setting process. PAGENO="0081" 75 ANTICIPATORY RESEARCH This program was initiated in fiscal 1978 in response to concerns of the National Academy of Sciences and the Congress that EPA was not conducting enough research of a long-term nature nor enough research on newly emerging problems. It is the principal vehicle within EPA for implementing the President's basic research initiative. The program is not aimed at identifying new problems to regulate; rather, its goals are to identify and assess new problems and to develop fundamental understanding needed to make better informed judgments in the future. The fiscal 1980 budget for this activity provides for an increase of S7.5 million for the areas of Innovative Research, Center Support programs and Directed Research (see figures 21 and 22). In the Innovative Research program, we will expand opportunities for individual scientists within and outside the Agency to conduct fundamental environmental research. During 1979, we initiated within the Agency a competitive procedure which allows our own scientists to submit proposals for the conduct of basic research. These proposals were reviewed by outside experts and a limited number of scientists were selected. We believe this kind of opportunity will allow our own researchers to explore new scientific areas of concern to EPA at minimal cost. In PY 80, we will utilize the maximum flexibility allowed to us to take advantage of innovative assignment and personnel mobility to allow a three (3) position decrease to be absorbed by the 43-778 0 . 79 - 6 PAGENO="0082" ANTICIPATORY R S 0 : Dollars (millions) *4 FIGURE 21. PAGENO="0083" ANTICIPATORY R ~ D : Positions 240 200 160 120 if INTEWIScIP, FIGURE 22. PAGENO="0084" 78 program. A comparable competitive program to provide a select few outside scientists similar opportunities in exploratory areas will be initiated in fiscal 1980. An example of such an area is research into the application of the identification of cancer `hot spots." In fiscal 1980, the budget also provides increase~I resources for our Center of Scientific Excellence Program. This program is conducted at leading scientific institutions throughout the country. Puring 1979, we will start three institutional centers in the areas of epidemiology, advanced technology and groundwater research. In fiscal 1980, we are expanding this effort to include centers for intermedia transport, ultimate disposal of pollutants, watershed dynamics, and integrated exposure monitoring. We hope through these efforts to establish long-term research into fundamental problems and to further develop our relationships with the outside scientific community by taking advantage of the excellent talent available at various institutions. We also envisage many positive working relationships and exchanges evolving between our own staff and these institutions. For these activities, we are requesting an increase of $2.65 million within the program. Finally, the fiscal 1980 budget proposes increases for several T)irected Programs. These multidisciplinary programs are expected to develop from the findings of our Center of Scientific Excellence and Innovative Research programs. Two examples of areas for proposed increases are our National ~id Rain Assessment Program and our PAGENO="0085" 79 Cancer Research Program. These are the foremost new problems needing assessment in the immediate future. As you may recall, EPA first proposed the establishnent of a ~3.O million Acid Rain Progratn in the fiscal 1979 budget. The specific aim of the program was to conduct an assessnent of the effects on aquatic, soil, agriculture and forest ecosystems. While we did not receive specific support for this research last year, our perceptions of and concerns over the problem have risen dramatically in the intervening time. We haveevidence of low pR value rainfall in some Western states, reports of significant damage to many lakes in the Adirondacks, and information to indicate that soil systems and some crops can be severely impacted. Our concern is that fossil fuel combustion over extended periods may result in irreversible losses in soil fertility with commensurate losses in food and forest productivity. Accordingly, we internally reprogrammed resources to begin an assessment of the problem during FY-.79. We are working with the Pepartment of Energy, U.S. Ceological Survey, the Department of Agriculture, the National Oceanic and Atmospheric Administration and others on this problem. Within this budget we are proposing an increase of $~OO thousand to further supplement this effort. The Anticipatory Cancer Pesearch Program was started because of the growing suspicion that environmental pollutants play a significant role in cancer causation. The unique aspect of this program is that PAGENO="0086" 80 we are taking a multimedia approach toward examining the links between carcinogens in water supplies, ambient air and other sources and cancer in man. In fiscal 1980, we are proposing to expand our field activities aimed at examining "hot spot" areas. We will continue to support laboratory studies to develop techniques for use in field evaluations and will coordinate these efforts with the ~Tational Cancer Institute and other health agencies. The program will be reduced by four positions. Finally, in fiscal 1980, we will expand our forecasting and strategic planning activities. This expansion will be based on a review of environmental forecasting activities in other agencies. We believe strongly that improvements can be made in our ability to identify trends likely to have significant environmental consequences in the future. Special analytical studies of the long~~term impacts of the actions of other government agencies, and of societal and industrial trends, will be part of this effort. The results will play an important role in helping us identify areas of fundamental research to be pursued through our Innovative Research and Center Support Programs. \ This concludes my prepared statement, Mr. Chairman. I will be glad to answer any questions you may have. PAGENO="0087" 81 Mr. AMBRO! You may proceed. Dr. GAGE. I would like to move then very quickly to look at the total research progran~ from the point of view of what we call media. The media in our jargon are the various legislative authorities under which we seek appropriations for the research areas, for example, air under the Clean Air Act, the water quality under the Federal Water Pollution Control Act, as amended, et cetera. On this slide you can see that there are also a large number of in- creases and decreases. The major increases are in air, drinking water, radiation, and toxic substances. These four areas also comprise all of the increases for public health research initiatives. In the air area, we will be requesting increases for transport and fate work to improve our understanding of atmospheric processes. We will be asking for increased funding in the area of health effects of air pollutants of both the conventional health air pollutants that we are concerned with and the new toxic air pollutants we are increasingly becoming aware of. In the drinking water area, we have a substantial increase to sup- port the public health initiative as well as increased research on treat- ment techniques. In the radiation area, we will be carrying forward the Congres- sional mandate for non-ionizing radiation research which we received from the Congress last year and additional work to give us an extra- mural capability to look at exposures to non-ionizing radiation and effects on human populations. Finally, the other major increases are in the area of toxic substances where we are quite dramatically expanding our work in support of the many new activities we have to undertake to carry out the man- dates of the Toxic Substances Control Act. If I could move quickly to the public health initiative and give a different perspective here, you will see that we are requesting in an identifiable block of additional resources to the extent of $8't million and 46 positions. These again, as I mentioned, fall in the area of air quality, toxic substances, drinking water and non-ionizing radiation. This year's public health research initiative is really the culmina- tion of a number of forces at work within EPA as well as across the Federal Government to substantially improve our health data base on which so many of the costly reulatory decisions have to be made. The areas in which we will be strengtheningour health effects research and development represent a consensus of Federal agencies concer~ied ~with environmental health problems. Let me give you a little background. Last winter, four regulatory agencies were convened in a voluntary alliance called the Interag~ncy Regulatory Liaison Group. These four agencies were EPA, the i~ ood and Drug Administration, the Consumer Product Safety Commission, and the Occupational Safety and Health Administration. Under the IRLG we established a subcommittee which reviewed *the research conducted by all four of the agencies. Through this effort we identified a set of critical research gaps: short-term and screening test development, approved epidemiological methods, and a serious need for more accurate ways to predict hnman exposure. to toxic chemicals, PAGENO="0088" 82 Following the IRLG effort, the Office of Management and Budget convened those four agencies and the three health research institutes, the National `Cancer Institute, National Institute of Environmental Health Sciences and National Institute of Occupational Health and Safety for a cross agency toxic ZZB. That effort, which went on for a number of months, basically reconflrmed the findings of the IRLG study that, in fact, there were some major gaps in the environmental health research conducted by the Federal Government. [The following question and answer were submitted for the record:] Question: Did the IRLO subcommittee focus only on health effects research gaps or did they also identify research gaps in control technology or in the process modifications needed to control exposure to carcinogens and other toxics? Has the IRLO working group on research planning been phased out? It so, what mechanisms now exist to coordinate the longer-term en~vironmental health research conducted by the Federal Government, as ZZB efforts seem to focus on short-term needs? Is there a report documenting the IRLG findings? If so, please supply it for the Committee's files. Answer. The IRLO research planning group focused on research topics pri- marily in the health effects area, however, certain other categories such as ecosystems `risk benefit analysis, and systems for research priority setting were also included. The group did not address control technology or process modifi- cation research. Although that group has continued to meet since the November, 1978 IRLG report recommending increased attention to those areas identified as research "gaps", with the completion of two additional reports in the next several months, the group is scheduled to conclude its activities. The November, 1978 report is forwarded for the Committee's files; the forthcoming reports on toxi- cology testing and heavy metals research will `be made available to the Com- mittee as soon as they are completed. Within EPA, longer term environmental health research will be coordinated by internal agency research planning com- mittees, representing both regulatory and research interests in each major area. We expect that the IRLG will continue to play a key role coordinating research plans among the regulatory agencies and ensuring that research out- puts are made available to all potential users. Dr. GAGE. As a result of that cross agency ZZB, the EPA did receive in its budget this public health research initiative as identified on the screen in front of you. In addition, we have a commitment from the National Cancer Insti- tute to direct some $15 million worth of work in its budget re- quest to support the Environmental Protection Agency in its general regulatory programs. Our Administrator, Douglas Costle, has gone on record a number of times stating the concern that he has with the in- adequate state of the health data on which he has to rely to make these critical regulatory judgments on the precise timetables specified by Congress; and Administrator Costle and I have vowed we are going to leave our successors in a markedly better position than we happen to be in. We have been putting off making the long-term investments in the health effects and ecological effects research over the past 8 years of EPA's history and now we are determined to start making that long-term investment so that at least our successors will have a better data base on which to make these very difficult regulatory decisions. If I could go briefly through the public health initiative, the first area-air quality research-would have an additional $5 million atid 21 positions addressing the four items shown on the chart to the right: First, the major initiative in the assessment of human exposure to toxic air pollutants; second, new models and methods for studying the im- PAGENO="0089" 83 pairment of human breathing and other effects; third, more sensitive and rapid screening tests for the toxic effects of air pollution, and fourth, improved epidemiology methodologies. In the second area, toxic substances we are also undertaking a major initiative in the assessment of human exposure, either direct or through environmental pathways to manmade toxic chemicals. We will be work- ing on improved predictive and evaluative methods to determine fate and effect of toxic chemicals in human organs and in critical portions of the human food chain. I am very pleased with the third item shown here which will be completed with this research initiative and that is the establishment of a neurological research effort jointly with the Food and Drug Adinmis- tration. This will be located in our Research Triangle Park in North Carolina and will be jointly funded by the FDA and EPA. Fourth will be the development of more sensitive and rapid scree~i- ing tests for health effects and improved chemical measurement tech- niques to carry out the mandate of the Toxic Substances Control Act. In the third area, drinking water, we will be seeking an additional $5 million and six positions to conduct improved epidemiological studies of populations exposed to manmade organic contaminants of water which we find increasingly in drinking water supplies throughout the country. We also need to have more toxicological information on these contaminants, and finally, one of the tools we will be using in the toxicological studies will be improved screening methods for the chronic effects associated with such contaminants. In the last area, nonionizing radiation, we will be undertaking the identification of which human biological systems are most sensitive to microwave radiation and will be studying the mechanisms of interaction. Finally, we will be expanding, as I mentioned earlier, the extramural portion of that program which has been primarily in-house up to this point. We will be conducting exposure epidemiological monitoring studies of the general population near microwave sources. If I can turn quickly to the individual portions of the budget, look- ing first at health effects and ecological effects, et cetera, you will have a little more detail as to where the major increases and decreases are occurring. These charts, I might mention, have, been worked into the text, ~f the testimony, and that may be of some assistance to you in following these notes and following my presentatiQn here. First, in the health effects area the major increases again follow the public health research initiative trends: an increase of $13.2 million and 16 positions, in air quality; an increase of $4.9 million and 6 posi- tions in drinking water; an increase of $900,000 and 3 positions in nonionizing radiation; and a $7.6 million increase in toxic substances along with a 14 position increase. If I can turn to ecological effects now, here we again see the influence of the public health initiative. In particular, the $9.3 million increase and 11 position increase in the toxic substances control area bring into place this complementary portion of the public health initiative which will be looking at how toxic chemicals move through the human food chain and thereby, in many instance.s~ eventually expose human beings to those toxic chemicals or their derivatives. PAGENO="0090" 84 There is also in this portion of the budget a $700,000 increase in the air ecology area which will restore, we hope, the viability of the extra- mural portion of that ecology program which was reduced very se- verely last year first by position decreases taken by the Agency and 0MB, and then by a funding decrease taken by the congressional Ap- propriation Committees. There are decreases here in the water quality and energy area, the most marked being in the water quality area where we will be de- creasing by 15 positions. But I might point out quickly that in this particular instance many of the individuals who are working in the water quality area now can be reprogramed to work in the toxic sub- stances research area, so we will not be disturbing people who will be essentially working on tasks very similar to those they are doing now, Turning next to the transport and fate area, we have an increase, the major purpose of which will be to conduct special studies to develop improved air quality models to predict pollutant concentrations in complex and rough terrains and improve our ability to simulate the movement of ozone over longer distances. In the next area, monitoring and technical support, we have a major increase in the air quality area. We have increases in water quality as well. The major increase in air quality will be to improve our efforts to provide the highest quality environmental data we possibly can. We will be expanding our work in quality assurance for the na- tional air quality network and, in particular, for the new inhalable particulate network which we are now in the process of deploying. When we came before the committee last year, we asked for the re- sources to begin that new network, and by the end of this year we will have quite a few stations in place and want to make sure that data is of high quality. In addition, we will be continuing our work on carbon fiber research which was initiated in the supplement voted for EPA this past year. The reductions in manpower as shown on the right-hand chart are one of the few consistent patterns for reductions in personnel levels in the ORD budget. In all cases the positions which are being deleted in the monitoring and technical support program are those associated with the technical support activities and those individuals now pro- vide technical support to the program offices and to our regional offices where they bring their special technical expertise to bear, on helping the regulatory and regional offices carry out the technical studies they have to do in support of regulation. This was a decision which was taken jointly with the regulatory and regional offices through our zero-based budget process and reflects an assignment of these slots to higher priority efforts within the Agency. In the next area, control technology, we do have an apparent de- crease in the water quality area and in the pesticides area and a real decrease in the energy control category. In the water quality area, the apparent decrease is due to the fact that we are not carrying forward in our budget an $8 million one-time add-on made by the Appropriations Committee for a potable water reuse demonstration project voted by the Appropriations Committee this past year. That project will be completely funded with the fiscal 1979 funds and with matching funds from private sources. Therefore, we will not carry that $8 million forward. PAGENO="0091" 85 That reduction as you can see is not a full $8 million, so there are some healthy increases in that area. There is a $4.2 million increase to establish a major new program to demonstrate the methods for recycling industrial waste water to be used for industrial purposes and an additional $1.25 million increase to provide support for opera- tion and maintenance costs beyond those for conventional treatment plants funded under title II for certain previously funded research and development demonstrations; and also for new projects involv- ing the innovative and alternative technology sections of the Clean Water Act for sludge disposal. The reduction in the pesticide area is again an apparent reduc- tion due to the fact that we are not carrying forward a $2.5 million add-on which was made in the appropriations last year for a special integrated pest management study. We are continuing our activity iii integrated pest management at roughly the same level we had in 1978 and had envisaged in 1979 before the add-on. The decrease in the energy control technology area of $5.5 million is again the major decrease in the control. technology program. What we are going to be doing to accommodate that decrease will be phas- ing down even further our work in sulfur oxides control technology as we wind down the 10-year research and development and demon- stration program we have ha4 in that area. We will be deleting our work on waste fuel in which we have been conducting numerous stud- ies over the last few years where we take municipal solid waste and use it as a fuel supplement in coal fired boilers. The Department of En~gy has been expanding its program in the use of all types of wa~te, not just municipal waste, but the so- called biomass, and we feel that program has reached a critical mass at this point. We will be deleting our work in an area. We will also have to reduce some of our work on assessing the potential environ- mental impact of some of the emerging energy technologies. Finally, I would like to mention just a little bit about our antic- ipatory research program. As I indicated in my opening remarks~ we have been able to move ahead fairly vigorously with our anticipa- tory research program, even though we had roughly half of the re- sources requested in our 1979 budget because of cuts in the Appropria- tions Committee. We did undertake our innovative research program which we are ex- tending the opportunities to EPA researchers to conduct fundamental research of their own planning. In fact, on Thursday morning we will be announcing.the seven individuals who have been selected for this innovative research program, and I am very pleased with the quality of the proposals that these individuals have put forward. [The following question and answer were submitted for the record.] Que3tion. Please supply the criteria used in selecting individuals for the In- novative Research Program. Does this program generate long-term projects or do they only last for one year? If they only last one year, how are they part of the long-term research program? Answer. The Innovative Research Program is a special mechanism for solicit- Ing unique research ideas and approaches, for investigating a problem that may be only faintly perceived, and for providing ORD scientists the opportunity to conduct relevant studies for long-term problems which may not match immediate regulatory needs. An advisory panel of experts in appropriate scientific/engineering fields was utilized in the selection of proposals. The panel consisted of scientists from PAGENO="0092" 86 within and outside the agency to assure a balance between external and internal perspectives. The criteria used for selection of projects Included: Scientific/technical merit; Uniqueness/innovation; Research approach; Capability of investigator; Adequacy of facilities; and Overall relevance to agency mission. Projects within the Innovative Research Program are generally funded for 2 years. At the end of the funding period, a project may be resubmitted far com- petitive review. In this manner, a long-term project can be successsfully mon- itored for progress and relevancy. However, the Innovative Program is primarily a mechanism for surfacing fundamental and long-term research proposals as re- lated to EPA's overall mission, Major problems identified by the Innovative Pro- gram are expected to grow into long-term efforts and be supported by either the Center Support Program or the Directed Program of Anticipatory Research. It is hoped that the Innovative Research Program can give many ORD scientists an op- portunity to participate and thus give a broadly based "bottoms-up" approach to identify' future or long-term research problems. I think we are going to have the opportunity to give those indi- viduals a chanëe to hone their scientific skills to the sharpness we are going to need if, in fact, we are going to continue to provide the high quality scientific and technical efforts the Agency needs. We are also going to be funding with the 1979 funds three new research centers in the areas of epidemiological methods, ground water research, and advanced control technology. We have already received, I think, close to 200 applications from universities and nonprofit institutions from across the country, and are in the process of screening those applications before we make the award sometime in late spring. With the remainder of the money, roughly $3 million, we have been able to initiate. I think, a very aggressive acid rain research program. This program will be studying the impact of acid precipitation which seems to be due, in large part, by combustion of fossil fuels in this country. On lakes, soils, and vegetation, particularly in the North- eastern part of the United States, we already are beginning to see some very severe impacts of such acid precipitation. The increase of $7.5 million in this area will basically restore the anticipatory research program back to the level we had requested in fiscal 1979, and I think that with the extra year of planning we will be able to launch a very aggressive program in fiscal year 1980. Mr. Chairman, I have moved through the testimony very rapidly and I think it is for all probably to the better to give more opportunity for those questions about specific projects which my colleagues and I will be happy to answer. Mr. AMBRO. I would like to say for all of us, Dr. Gage, you have done a commendable job in extemporaneously synopsizing. I am sure `we do have questions and I would like to turn to Mr. Brown if I may to get things rolling here. Mr. BROWN. Your very comprehensive statement, Dr. Gage, raises a number of questions with regard to the overall program. I think we will come to the increased focus on the health effects and the various initiatives aimed at quantifying the relationship between health and environmental pollution in various ways. The recent action of the Administrator in changing the oxidant standard to an ozone standard and increasing the limits from 0.08 to PAGENO="0093" 87 0.12 raises the question of the amount of data that we have which jus- tifies this kind of regulatory action. Of `course, your own structuring of the research planning committee operation, as you `mentioned, to bring together the research and regu- latory personnel in a joint effort to focus planning on this subject, it seems to me, to be a very desirable process to follow. Dealing specifically with that modest change in numbers, can you describe briefly the nature of that data which leads you to feel that the number 0.12 is `better than the number 0.08? What is the relative assurance of these numbers? What degree of cer~ainty can we `have that one is any better than the other? Dr. GAGE. What we did within the Agency in developing the final standard was a very rigorous review of all of the health data which had been done before the 1970 standard and the intervening period after that standard. What we found by and large was that there had been some very useful and very powerful experiments done within the past 3 years which we primarily had to focus on. As you may or may iiot know, the one study which had been done by Shetland and Landow, an epideiniological study in the Los Angeles basin area which had been used as the primary basis for the 1970 standard, on closer scrutiny turned out to have some errors in it. In particular, there `was measure- ment error which indicated the ozone level or the oxidant level M which health effects were seen in the populations was not in the vicinity of 0.1 but rather in the vicinity of 0.2 ozone. Mr. BROWN. A slight 100-percent error. Dr. GAGE. Like a 100-percent error in the measurement. So the util- ity of that particular study had to be put in quite different perspective. Mr. BROWN. What `was the population Size of the sample, do you recall? Dr. GAGE. Of the Shetland and Landow study I do not know oil? the top of my head. I remember it was quite a large population study that they did in the 1960's in Los Angeles. What we focused on primarily were very carefully controlled clini- cal studies, several of which were conducted at the Rancho Los Amio~os Hospital in the Los Angeles area as well as several other studies. WIat we determined `from those studies was that under various regimes of exercise, symptoms and possibly even effects begin to set in very clearly in the range of 0.2 to 0.25, and there was `also some indication that that range might extend down to about 0.15 on up to 0.25. Looking at those clinical results along with several other types of studies-such as some epidemiological studies done in Japan which reported a variety of symptoms in schoolchildren in Japan, together with a variety o'f animal studies where animals were first exposed to ozone and then subjected to a bacteriological challenge and seeing the much increased mortality rate in the test animals at ozone levels as low as 0.01-and taking all these things tOgether the Administrator de- cided was the most appropriate level at that particular time `was 0.12 parts per million of ozone. This would, he felt, give a reasonable mar- gin of safety, which `he is required to do under the Clean Air Act, below ~hich we could see as the onset of effects in human beings. This is what he said he had to do as a prudent man in the face of quite considerable uncertainty. PAGENO="0094" 88 Mr. BROWN. Well, I am not nitpicking about a particular regulatory decision. I am interested in having the record reflect the adequacy of the data base on which decisions of this sort are made and if I may follow up very briefly, was there taken into consideration the other side of the coin; namely, the regulatory impact on cities and industries measured in some way, quantified in dollars or what have you, of this change in the standard? In other words, is there a process that is beginning to give us a risk benefit kind of an assessment in this regulatory area? Dr. GAGE. I think you have asked two separate questiOns. First, were the studies of the economic effect and other impacts of this new regu- lation done in the Agency? Yes, they were done quite carefully. They were also done by several other groups and the results were debated and the assumptions were contested. In any event I think we had a ballpark figure of what the various levels of ozone control would require. However, I must point out that the Clean Air Act does not allow the Administrator to take into account the economic impact of the decision. Let me make that very clear, that the Conpess has very care- fully proscribed the Administrator from considering anything other than the protection of public health in the establishment of national ambient air quality standards. So while, as responsible public officials, we feel that we `have to know what the economic impacts are as part of that process, those economic impacts cannot, by law, be used in the establishment of those standards. If Congress would like to have that done otherwise, then Congress will have to change that law. Mr. BROWN. Correct. Getting back just to the health effects data and again merely for the purpose of illuminating the process rather than nitpicking, was the broad scope of currently available health effects data subjected to any sort of review by a qualified scientific panel in order to advise the Administrator as to what the weight of the data might prescribe? Dr. GAGE. The process for developing an ambient air quality standard in EPA is quite lengthy and quite complex. The first step is the preparation of a criteria document. Responsibility for that falls to the Office of Research and Development, in fact, to our Office of En- vironmental Criteria and Assessment located at the Research Triangle Park in North Carolina. That document is prepared with the help of the best outside scientists we can find. On this particular document, 12 outside scientists participated in its preparation. Once the criteria document is completed, it is submitted to our Science Advisory Board, the body your subcommittee. helped write into law as the official review body within the EPA. After se+eral reviews and adjustments by the Board and adjust- ments in the text of the criteria document by our staff, that criteria document then is essentially completed and submitted to the Admin- istrator for his consideration along with the regulatory control options prepared by the Office of Air, Noise, and Radiation which is the regu- latory office required to prepare the recommendations for such standards to the Administrator. So, the Administrator gets a statement of the best knowledge that we have today on the health effects of an individual air pollutant along PAGENO="0095" 89 with the recommendation for either one or more options for him to consider in his decisionmaking process. Mr. BROWN. In a recent visit to the Health Effects Research Lab- oratory down at Research Triangle Park I observed the process of evaluating respiratory effects from particular concentrations of ozone and I, of course, made no effort to analyze the scope of the experiment, but I was told that one item that respresented a relatively new aspect of this was, in what I assumed were ordinary healthy males, that there was a substantial variation in pulmonary effect resulting from the same concentration of ozone which leads one to the assumption that if there is a substantial difference in effect in ordinary healthy males, the same phenomenon might express itself in ordinary unhealthy males or unhealthy females, or children and so forth. In other words, there may be a wider range of effects from the same concentration than we had previously factored into our considerations, you see? Was that point explicitly considered in the change in the standard? Dr. GAGE. It was explicitly considered to the extent that it was one of the factors used by the Administrator in the margin of safety which he set in establishing the 0.12 parts per million of ozone; that and a variety of other factors were considered in the margin of safety. I think what you saw as a result of our experimentation there in Research Triangle Park is one of the more powerful discoveries that we have made in this air pollution effects area for some time. It has some very real implications. It shows that even among the six of us sitting here at this table there might be some considerable variation. I should also point out that while a number of the studies which have been done indicate that ozone and other air pollutants do cat~se effects on the ability of people to breathe, the vital capacity of the lungs or certain blood changes might vary quite widely in individuala One of the key studies we had to rely on used only six patients. Another study used 20 patients. Those studies were compounded some- what in that in the case of the six individuals, one probably did have a compromised respiratory history to the degree that he had asthma. and had to take medication up to the age of 18, although he had de- veloped into a long distance runner after that time. All of these factors have to be taken into account and I think what that is going to lead us to is taking much larger samples, much larger groups of individuals that we put through these clinical studies, and hopefully be able to confirm or deny those studies by looking at literally thousands of people in the human population. [The following question and answei' were submitted for the record:] Queation. What funding Is programed for clinical studies at the Health Effects Research LaboratOry at Research Triangle Park, in the fiscal year 1.80 bu~lget request? What projects are planned? Where are they Identified In the budget request? Answer. Funding for clinical studies at the Health Effects Research Labora- tory at Research Triangle Park for fiscal year 1980 Is programed from two parts of the Air-Re&~earch and Development-Health and Ecological Effects portion of the budget request: Health Effects.Criterja Pollutants and Health Effects-Non- Criteria Pollutants. These parts appear on pages A-13 through A-17 of the Environmental Protection Agency 1980 Budget Estimate and the clinical studies are identified on those pages. The proposed budget for clinical studies for fiscal year 1980 is approximately $7.5 million. Approximately $3.00 million Is planned for Intramural projects and $4.5 million for extramural research. PAGENO="0096" 90 The clinical research program Includes work on human short-term chamber exposures to inhalable particulate pollutant aerosols and criteria pollutant gases alone and in combination which resemble realistic ambient exposures. The design of these studies will produce Information relevant to actual temperatures and humidities experienced by people and will use both normal populations and populations more sensitive to the ill effects of the pollutants. We will also conduct studies to improve pharmacologic simulation of diseased respiratory airways and identify cardlorespiratory physiologic effects from pol- lutant exposures. The program also includes the following studies: -hematologic and enzymatic biochemical. metabolic, and Immunologic studies of persons exposed to various concentrations of air pollutants; -developmental studies for personal pollutant dosimeters to support population studies; -pulmonary cellular and chromosomal studies of exposed individuals; -studies of the effects of bacterial infections in combination with pollutant exposure. Mr. BROWN. I will not belabor this and will yield to my colleagues for their questions. I have a number of other questions, but I am inter- ested in focusing first on adequacy of the research process, and ob- viously, I have a particular interest in air health effects, and there are many other aspects of this, including the question of the adequacy of the population samples and the need for much stronger epidemiolog- ical programs, that need to be explored, but I will not explore them at this point. Let me just ask one additional question. You refer in your written statement under air ecological effects to the fact that the study on- going over many years on the ecological effects of air pollution in pine forests of southern California will be completed. As you know, there was some questions of this last year. This was very disturbing because I think to curtail the final analysis phase of an ongoing 5- or 10-year program which will produce the results is very shortsighted in terms of research. May I just ask you to affirm that that type of approach to the greatest degree possible will be avoided in the future; that is, curtailing a long-term project at the time when its results are due for completion? Dr. GAGE. Well, Mr. Brown, I wish I could assure you of that. The fact of the matter is I have to lay that right back at the doorstep of Congress. The reductions that we took in our appropriations last year cut almost $2 million out of the air ecology program. We were also faced during that same period of time with reducing the number of individuals we had working in that area from 32 to 5, and yet, no money was made available for paying the salaries of the individuals who were to be let go from the beginning of the fiscal year until the point through the year when they can actually be given their reduction-in-force notice. The process of conducting that reduction in force is taking place, and we have been trying to do that in the most humane way possible and give the individuals a chance to relocate if we can possibly find them other jobs. So, we have had those additional salary costs of those individuals through the better part of this year. The fact of the matter was we had to scrounge down to the last nickel to find the $130,000 to extend that grant for 1 more year. It is not something that was arbitrary and capricious on the part of our Office. The fact of the matter is that two-thirds of the resources that we asked for last year were not voted by the Congress and that probably places long-term research much' PAGENO="0097" 91 more in jeopardy than any capricious decision made on the part of a bureaucrat. Mr. BROWN. I recognize the culpability of the appropriations proc- ess in this respect and we will seek to address that problem where we can. Dr. GAGE. We are very sorry the reserves in that particular case were quite upset. We did reprogram resources and did find the $120,000 to carry that project through the data analysis phase. Hopefully, with the $700,000 increase in that area, we will again, as I mentioned ear- lier, have a viable air ecology program in the future. Mr. BROWN. Perhaps this subcommittee will be able, in its wisdom, to avoid making any cuts in an area like that, and I hope the Ap- propriations Committee will do the same. May I ask that the new ozone criteria document you referred to be submitted for the committee's files? Dr. GAGE. Yes; you certainly can. Mr. BROWN. Thank you, Mr. Chairman. Mr. AMBRO. Thank you, Mr. Brown. I said at the outset that the subcommittee was fortunate in having on it the previous ranking minority member once more, and I would like to turn to him now for his round of questioning. Mr. Walker? Mr. WALKER. Thank you, Mr. Chairman. I would like to join my colleagues and thank you for your com~ prehensive statement, Dr. Gage, and welcome you back for another round of discussion on budgetary priorities. One of the things, as you know, that I discussed in years past on this subject is how research can be utilized in* a way to make better use of tax dollars, and I think we see ourselves in a budget crunch sit- uation where it becomes even more apparent that there is some need to do that; primarily research that can be used in a way of monitoring what is already going on to see that we are making the best use of our dollars in the environmental area. One thing that has come to my attention recently, that I wonder if we could discuss a little here today, is the whole area of the construc- tio4 grants program, particularly the sewage treatment plans pro- gra~m. I have become increasingly concerned that some of the money that is now being devoted to that and, of course that makes up the largest portion of the EPA budget, some of the money that is going into that may be resulting in duplication of effort. That is, there is existing sewage treatment capacity in areas and regions where we then go in and add new sewage treatment facilities. My questioning involves whether or not there is any research program for monitoring what is available in terms of treatment capacity in regions, so that as grants are allocated, or as applications are received, whether somebody at EPA is checking to find out whether or not maybe, instead of building whole new facilities, we could be tying into existing facilities at a much lower cost and with a much more, efficient use of tax dollars. Dr. GAGE. Mr. Walker, I am far from being an expert on the con- struction grant program. The responsibility for the construction grants falls under the Office of Water and Waste Management and our regional offices. In fact, I know relatively little about the review process 43-7780-79.? PAGENO="0098" 92 for the award of those grants. I would be happy to pass any questions that you have on to my colleague, the Assistant Administrator in that area, and ask him to respond in any detail. Mr. WALKER. Are you aware, though, if you have ever been asked to do any research with regard to what exists, and whether or not there is some internal safeguard mechanism for assuring that, as we build these extremely expensive projects, we are not duplicating effort unnecessarily? Dr. RIORDAN. Maybe I can address that, Mr. Walker. The Agency relies heavily upon the States' priorities for choosing projects to fund under the sewage treatment grant program. `Those lists are established within each State based upon criteria they develop for ranking of projects. The criteria differ from State to State so I cannot generalize about their treatment of excess capacity or du- plication of facilities. I do know that recently some very rigorous regu- lations were being developed by EPA in the cost-effectiveness area having to do with availability and capacity related to the projected population growth in the area. I cannot give you the exact criteria for projecting population use to available capacity, but they are designed to avoid the problems you are concerned with; that is, either expansion of capacity beyond reasoable projected needs, or duplication of existing capacity which could meet the water quality needs. Mr. WALKER. If I am not mistaken, one of the problems with those regulations is that they are using population projections based upon 1960 census data rather than using updated material. I am familiar with one situation in my area `where there is a plant that is only using 25 percent of its capacity when it was built, and yet, we have a whole series of new EPA grants coming on line in that community where, in some cases, the interconnection could involve maybe 500 feet if, in fact, the communities were instructed that they have to tie into existing treatment capacity rather than build new treatment capacity. What I am wondering is why somebody is not taking a look at what may be available all the way across the Nation of this type, and there- by save us literally millions of dollars. In my own perspective I think part of the problem is with engineers who are not advising communities in any way that they could tie in with existing capacity. They want to build new plants and they are interrelated to the grant program, but I am looking at it from the standpoint of some research. Would it not be valuable to have some data on hand to tell commu- nities, to say, in fact, we are not granting you money for new construc- tion because there is existing treatment capacity within your area that you could tie into; but at this point I am not sure we have that kind of data.. Dr. MURPHY. I think there is a question of whether or not this could be called a research problem. The data is reasonably available. The several grant programs, such as sections 208 and 201 facility plans, provide a mechanism for obtaining that data. We have never `been approached to go out and survey what data are reasonably available. It's probably available for anyone who would take the time to look. The deficiency might be more on the decision process than the collec- tion of data. PAGENO="0099" 93 Mr. WALKER. Are you saying data exists? Dr. MURPHY. Well, it certainly is easily obtainable, even in terms of existing treatment capacity and facilities; yes, sir. Dr. GAGE. The Congress intended that the construction grant pro- gram be carried out very strongly at the State level. The EPA Head- quarters and EPA Regional Offices' primary function is in the role of a review capacity where they look at the detailed applications and justifications which are prepared by the individual cities and munici- palities and even at that, we have relatively few people to look at the very detailed literally volumes and volumes of applications that come in in this kind of a program. I think, very frankly, that the first line effort has to be done at the State level; that that is where the review really has to take place. That was the intention of Congress and if there is a breakdown, then we have to get involved. We cannot take the responsibility for those. pro- grams away from the States. That was also written into the law, but that is a little bit like the first strike nuclear capability. You really do not want to use that, or you end up inheriting a program at the Federal level where you do not have the resources to do a better job than at the State level. Mr. WALKER. Ultimately, what I am concerned about is, and we had some discussion in this subcommittee the last time, and I indicated at that time that I was pleased that EPA has finally decided to go ahead and use some of the innovative technology in sewage treatment that has been developed along the lines, primarily the kind of work done in the research and development programs, but if we are con- tinually tied to decisions being made by engineers in the field to spend all of this money, we will never get back to utilizing all of the gOod work done in the research area, and I am wondering whether or not there is some overlap here that really involves some discourse between you and the program people. I do not think you can slide this off to the program people and say there has been failing in the States when, in fact, we are concerned about bringing innovative, and in some cases much less expensive tech- nology on line, and the whole sum total of it adds up to getting more bang for the buck. Dr. GAGE. In the first instance, I do think the responsibility for reviewing existing grants does fall on the program office in the States. In the latter instance, we have an active cooperative program be- tween the Office of Water and Waste Management and Research and Development in advancing innovative technologies. The program of- fice has given us positions, and in some cases, people to help with the program. I would like Courtney or Tom to make a comment on this. Dr. RIORDAN. The section under the new Clean Water Act which calls for grants and which provjdes extra money for innovative and alternative projects is now being implemented. The program officers have looked to the Office of Research and Development for assistance in two ways. In the first place, Mr. Walker, we were asked to develop a guidance manual for use in the review of these projects to assure they are inno- vative or alternative. We have already developed the manual and are now in the process of getting it in place in the regions to carry out the reviews. PAGENO="0100" 94 Mr. WALKER. Let me interrupt. Is any part of that review checked to see if the new technology is needed at all? Dr. RIORDAN. Absolutely. We have developed an extensive array of new technologies and that is one of the important barriers that a new project would have to pass, i.e., that it is innovative, or cost effective. That is built into the review process. In addition, we have built into the process post-construction evalua- tion after some of these projects are in place to assure that they come up to expected performance. ORD's involvement is extensive, but it is solely from the point of view of technology and science. We do not address the question of whether a project should be in an individual community or tied into a regional system. That is not part of the ORD review system. ORD helps only to determine whether a project is innovative or alternative in terms of technology or costs. [The following question and answer were submitted for the record:] Question. Is EPA the only source of "innovative technology" for sewage treat- ment? If not, who else supports RD&D in this area? Answer. Essentially EPA is the only agency that supports the research and development of innovative technology for sewage treatment. We have tradition- ally been the lead agency in this area through our program of research and devel- opment grants to universities, municipalities and indirectly by contracts with industry and consulting engineers. No other agency has a program to develop new technology for sewage treatment at the pilot plant scale. The National Science Foundation, until recently, supported a small program for basic research; however, because of other priorities they will no longer be supporting any re- search in the sewage treatment area after fiscal year 79. The research efforts of waste water equipment manufacturers are concentrated primarily on product improvements and cost reduction rather than on basic research or process development. Where new products are involved, much of their marketing strategy frequently depends on demonstrating the new developments through the EPA grant programs. ORD has not engaged in many demonstrations for the past 6 years, because of other priority demands on resources. Mr. WALKER. All right, I am going to have some additional ques- tions in the area and I'll probably make sure they get directed to the right shop down there, but I do think there are some severe problems, and severe questions have been raised in my mind with regard to specific kinds of projects. I have seen in recent months where, in one case, we went ahead with an $11 million project that could have been accomplished for $4 mil- lion simply with a tie in, in pumping stations. I do not understand that kind of thing and I really think it is time to begin to assure that the taxpayers' dollars are being well spent in this area. The results are the same. We. still get the sewage treatment. We just do it for a lot less cost. Let me turn if I can, Mr. Chairman, to the rainwater runoff prob- lem. I would like to know what efforts, if any, EPA has underway now to determine the impact of rainwater runoff on the ouantity and quality of available drinking water supplies in the United States. Dr. MURPHY. We have two efforts, one dealing with urban runoff in a metropolitan situation. We are not looking specifically at drink- ing water. However, we are looking at the discharge of pollutants, including toxics of any sort, to surface waters which can be used for any of several purposes-recreation, drinking water, or whatever. Our primary effort is on the problem of toxics. This includes matters such as the accumulation of toxics in sediments. The problem varies PAGENO="0101" 95 widely from area to area, depending on the industries that are present and the hydrologic conditions. With regard to runoff in rural situations, such as agricultural areas we are combining our studies with a number of pilot projects that EPA has underway with the Department of Agriculture. These are examining best management practices for agricultural systems and examining the actual improvement of water quality that will result when those projects are put in place. This would include not only the traditional pollutants like sediments and other nutrients, but also toxicants, such as pesticides. [The following question and answer were submitted for the record:] Questioa, The JfY 1980 budget request shows a decrease of $134,900 in urban runoff and aquaculture research. How much is programmed for the urban runoff problem in FY 1979-FY 1980? How much is programmed for the agriculture run- off problem? Answer: Urban runoff Aquaculture Agriculture FIscal year: 1979 $1,421,000 $340,000 $3,097,000 1980 1354 000 272,100 3,217,000 Difference -67, 000 -67, 900 +120, 000 Mr. WALKER. I am particularly concerned about the urban runoff problem. Has it been identified what the major urban sources of pollut- ants are in the runoff problem, and are there any ideas as to how we are going to go about reducing it? Dr. MURPHY. One of the problems is the wide variability in the data. Sources include discharges to surface of the land, such as spills as well as pollutants which may come with precipitation. This includes air pollutants such as heavy metals that wash off the surface of the land. The analyses we have carried out in the last several years indicate that the data is so wide ranging that it is hard to draw conclusions as to specific sources. Dr. GAGE. I might mention, Mr. Walker, in connection with the studies for the new effluent guidelines required by the Clean Water Act of 1977 there are a number of mass balance studies which are now being carried' out in the Office of Water and Waste Management. They are looking at a number of cities, several dozen's of cities if I recall the rough number, and trying to determine what are the various sources of these toxic materials that we are most concerned about within the Agency now, where do they accumulate within the urban storm water collection system, and where do they go from there? I think these studies should be out within the next few months and we will probably have a much better data base in a very short period of time. , Mr. WALKER. Does any of this include any look at the impact of building a 100-acre shopping `center or building suburban develop- ments, and the impact they have on the runoff problem? Is that included within these studies? Dr. MURPHY. I do not think our scientific capability allows us that precision. The data to date have been so sparse and variable that we PAGENO="0102" 96 are a number of years away from being able to predict the impact with that level of specificity. Mr. AMBRO. I wonder if I could interrupt you? Mr. WALKER. Certainly. Mr. AMBRO. Long Island extends from Coney Island 120 miles out to Montauk Point. It sits on the same geological substructure throughout. From the time that Brooklyn and Queens were developed and paved over, the lack of water permeating into their aquifers caused those two boroughs to lose their aquifers. They dried up and collapsed. Once they are gone, they are gone forever. It seems to me that occurred many, many years ago and the problem was pointed up quite clearly in the reality and it seems to me, too, that nobody seems to look at those kinds of clear-cut losses and that is the kind of thing, I think, that leads Mr. Walker to ask his question. We do know that when one paves over a community which requires the permeation of rainwater into its aquifers to continue to build them up, that that problem is the most pressing problem. The other has to do with rainwater runoff with respect to a couple of simple ingredients. For example, now calcium chloride and sodium chloride are being poured all over our roads. Runoff with respect to that in estuaries, streams, ponds and other bodies of water as well as leaching into the groundwater should be something that is pointed up and looked at right off the bat with respect to this, because we have had the problem ongoing for years and years. We have all sat here and talked about this same problem year in and year out, and I do not see any specific focus with respect to it. We have an awful lot of interesting and esoteric programs ongoing but the thing that is of significance to municipal managers and where we have the capability at the Federal level to do something about it, seems to go untouched. I do not know if that specifically is the thrust of what you are saying but it seems to me that that kind of a problem is one that affects us all when we go back. It is something that should. be evaluated in the minds of all of those who run this office. Mr. WALKER. I certainly agree with that, Mr. Chairman, and I would follow that up by saying I come from an area where we have seen an increasing amount of urbanization in recent years. During that period of time we have gone to things like sewage treat- ment systems and all of this and yet, with the urbanization, at the time of heavy rains we see what used to be small runs through fields become almost major rivers. All the work that has been done is lost when you introduce into the streams a great deal of polluted runoff from subur- ban developments and shopping centers, and so on. Certainly, this kind of nonpoint pollution needs to be looked at as a major kind of problem in increasingly urbanized areas. Dr. MURPHY. We have looked at a number of things, specifically salt runoff from road deicing operations. We did a study several years ago which pointed out the cost and benefits from the pollution standpoint including the greatly increased costs from rust to automobiles. I think the uncertainties now relate to how you quantify the safety factors- the protection of human life from the increased use of salt-EPA does not have a broad mandate for water resource management. Our statu- tory responsibilities focus on the water quality. Therefore, we don't do PAGENO="0103" 97 research dealing with broad water resource problems, except those directly impacted by projects we may fund or manage, such as con- struction grant projects. We do try to consider the broader water resource implications, but that is primarily a responsibility of the States. It is not a direct man- date to EPA. Mr. AMBR0. If you will yield, Dr. Murphy, it seems to me that we are dealing with the Office of Research and Development here and while the States can do some things, do you not think we ought to have the capability of developing alternatives to the kinds of toxic substances that we use through the capability of one or another of your offices to develop those kinds of alternatives? For example, if we say that we should ban the use of all the chlori- nated hydrocarbons as pesticides, DDT and the others, is there not someone looking into the efficacy of developing an alternative which is not toxic? If we say that salt does a variety of things to automobiles, that is wonderful. The stress here is on health effects on people and if we use salt and calcium chloride to an inordinate degree, there is no question we have to effectuate a balance. Is there not someone looking at developing alternatives to all the new developments of chemicals is that are less toxic or less harmful? Why is there not a relationship in EPA's ORD between the identi- fication of contaminants on the one hand and the kind of remedial ac- tion, either through technology or the development of less harmful or unharmful sources on the 9ther hand? Do you not think that i~ where we should be going? Dr. GAGE. Certainly, with pollution control technologies, we have tried to maintain our very viable program there. But in terms of devel- oping alternative chemicals which might serve as substitutes for cer- tain commercial uses which are causing environmental problems, we have gotten time and tIme again very clear messages from the Office of Management and Budget and from the Congress that those are areas we should not be working at from the point of view of letting the free market provide the incentive for industrial research along those lines. I think that message has been quite consistent. Mr. WALKER. Well, I certainly understand that basically water quality has been the mission assigned to EPA and I would assume we can take it then that water quantity is the mission of the Interior Department. Do you~not ever cooperate where the two questions overlap? I think what I have really stated here is a question where you have overlapping kinds of problems that you know is one problem for the community that faces it. Could there not be some kind of cooperative arrangement here to begin to look at some of these things which are really increasingly great problems, at least here in the East? Dr. GAGE. We do have many cooperative programs with the Geo- logical Survey. I do not believe we have any in the area of urban run- off since the Geological Survey has typically tended to work in the areas other than urbanized industrial belts of the country. Most of their water quality stations lie far outside of the SMSA (Standard Metro- politan Statistical Area). PAGENO="0104" 98 Mr. WALKER. Maybe we need them back where the people live. Dr. MURPHY. I do not think we mean to imply, Mr. Walker, that the two are separate. Certainly, the relationship is very close. If we set water quality standards assuming a certain flow in a river and there is no water in the river at certain times of the year, our standards have very little meaning. In many cases we have to consider the hydrology or flow rate of a. river in setting rational water quality requirements. We work very closely with Interior on this. Mr. WALKER. Let me get to one general management question and I would like to yield back to our chairman. Can you tell me, Dr. Gage, how many positions in Grade GS-14 and above are currently unfilled or filled with acting incumbents in ORD? Dr. GAGE. I would have to provide that for the record, but would be pleased to do so. Mr. WALKER. I would appreciate having that for our record. Are there a number of such vacancies? Dr. GAGE. I would say relatively small numbers compared to our large base of 1,751. Mr. WALKER. Thank you, Mr. Chairman. [The information referred to is as follows:] As of April 1979 there were 15 vacancies in ORD at the GS-14 level or above. Six of these vacancies were being filled with acting incumbents. Mr. AMBRO. Mr. Blanchard? Mr. BLANCHARD. Thank you, Mr. Chairman. I am relatively new to the whole area and am interested in it. I am wondering when someone comes to you-or is there a place to come to in your office and say they know of a toxic substance that is either being sold or thrown around the water or air supply, or whatever-what do you do? How does all that work? Is there a place where somebody can go to lodge a complaint? Then what is the process followed? I guess I am curious as to how many other agencies get involved in that along the way. Dr. GAGE. It is our impression that nearly everyone gets involved at one time or another, Mr. Blanchard. Very frankly, we take it seriously and receive such complaints wher- ever we are in the organization. If they get to us because we are sup- posed to be the scientists in the Agency, we accept the concerns and try to get it to the appropriate office. The latter phrase is the key thing. We have to apply a certain amount of judgment as to what is the nature of the problem and what would be the likely redress. If it is a haz- ardous waste disposal problem, we get that to the Office of Solid Waste as quickly as possible. If it is a problem. of a spill, we get that to our Spill Coordination Office within the Agency. Generally, we can find some way to help or give advice to get the in- dividual into a much more knowledgeable position. Mr. BLANCHARD. Do you have an Office of Complaints? I assume peo- ple make comp'aints, and these people may be in a position to know something about science or they may be people who do not-but do you test, or what do you do? What is your mission under the Toxic Substances Control Act? PAGENO="0105" 99 Dr. GAGE. In the Office of Research and Development our mandate is quite broad to conduct research and development which supports the various sections of that act, all the way from developing new chemical testing protocols to advising the Office of Toxic Substances on the quality control used in industrial processes. Mr. BLANCHARD. I do not have a specific question, but I am just wondering when somebody writes me, who do I tell them to go see? Dr. GAGE. In most instances, the offices out in the regions, the 10 Federal regions are those in the best position to get somebody on the spot more quickly to help if, in fact, we in EPA are to respond, and they have good tie-in with the other Federal organizations in the re- gions, such as the Occupational Safety and Health Administration. If you get those kinds of questions they should be. referr I directly into the regional administrator of region X. In your case, is would be the regional administrator in Chicago who has people who deal with these kinds of calls every day, day in, day out. Mr. BLANCHARD. How do you go about testing, though? I assume all this R. & D. leads up to something. I am delighted to see your emphasis in moving into the anticipatory research area. My colleagues have pointed out this should receive more attention and there are limits as to money. I think the last time I saw you fellows, I was sit- ting with a panel that was worried you were doing too much, contrary to the feelings of this panel. I assume you are conducting some tests, right? Dr. GAGE. We conduct many types of tests under many different parts of our programs. I am not exactly sure of the focus of your question. Is it a matter of conducting tests on chemicals which might have been identified in someone's drinking water? Yes; we do that and similar things like that. The first line of ac- tivity is usually done at the State level, if you have a well-developed State environmental department. I believe in the State of Michigan the State programs are very well advanced and typically testing would be done on well water or surface water in a State laboratory. If that capability is not there, it is typically done at our regional surveillance and analysis laboratories which are typically located in the same cities as the Federal regional headquarter~s. In very specialized cases we will do those kind of tests in some of our laboratories where we have special instrumentation or special expertise to conduct such tests. Mr. BLANCHARD. When you say "our laboratories" what do you mean? Dr. GAGE. The 15 research laboratories which fall under the pur- view of Office of Research and Development. Mr. BLANCHARD. You have 15 laboratories under your domain in addition to regional offices. How many regions are there? Dr. GAGE. There are 10. Mr. BLANCHARD. That have laboratories? Dr. GAGE. Yes. Mr. BLANCHARD. Not under your domain, but you work with them? Dr. GAGE. Yes; they are surveillance and analysis labs. They do quick-turn-around chemical analysis. Mr. BLANCHARD. Most States or many at least have their own health departments or their environmental departments. PAGENO="0106" 100 Dr. GAGE. Yes. Mr. BLANCHARD. Some sort of research laboratories that could be used? Dr. GAGE. Yes. Mr. BLANCHARD. Then I take it that you contract out. To what de- gree do you gather, publish, disseminate, and work with universities in testing, or industry, or some other institutions? Dr. GAGE. We use universities very broadly in the conduct of our extramural research which constitutes over two-thirds of our research effort. In fact, I think that projected for this next fiscal year we will have something like $70 million dollars' worth of research activity in the universities around the country. Such projects do involve testing in one way or another. We do not retain universities for routine testing activities if that is the thrust of your question, but many times we do call on the universities or contractors to perform very specalized testing if the need arises and it seems to arise quite often. Mr. BLANCHARD. How many different committees are you dealing with in the House of Representatives to get your authority and money or that you are called before? We are dealing with your budget, or at least part of your budget. How many different panels do you have to appear before to get authority? Dr. GAGE. Well, three fairly regularly-this committee which writes our authorization in the House and takes a very close look at our budget; the Appropriations subcommittee which prepares our appropriation, and then many times we also are called to appear before the House Commerce subcommittee, the one which was chaired most recently by Mr. Rogers who just left the Congress, and I believe now by Mr. Waxman. Those are the three in the House that we deal with, although I have personally appeared before at least another half dozen subcommittees at one time or another on specialized issues. Then there is the Senate. Mr. BLANOHARD. How many in the Senate, the same three? Dr. GAGE. Typically, it is the same sort of pattern on the Senate side as well. It pretty closely reflects the activity on the House side. Mr. BLANCHARD. How many programs are you working with? I hope you will excuse me for asking such basic elementary ques- tions but having been here 4 years I still do not know it all yet. How many programs are you administering, relating to, or covered by in whole or in part, do you know, offhand? Dr. GAGE. Well, we conduct research, as I indicated in the first slide, under 8 different legislation authorizations and when you throw in 2 other budget categories, we have at least 10 different budget cate- gories. Now, how that actually breaks down, is that what you are asking? Mr. BLANCHARD, Budget subfunctions you mean. Dr. CAGE. As far as how that breaks down in terms of actually implementing the program we have to take the research moneys which are associated with, for example, drinking water, and we do work on health effects and drinking water control technology in drinking water. That looks like two budget subcategories there, but, in fact, we have to call on five of our laboratories to add different parts of those activi- PAGENO="0107" 101 ties. That is about a $16 million or $17 million budget as I recall and a good part of that goes outside to private contractors and universities. We may have in that area alone, 50 or 60 more different entities contributing to providing the outputs from our so-called drinking water research program. Mr. BLANCHARD. On the subject of anticipatory research what other departments or agencies are in that? I recall seeing somewhere that HEW has an office of toxic substances and they are getting into that. Are you familiar with that or did I misunderstand something I read? Dr. GAGE. Well, of course, the bulk of the more basic research spon- sored by the Federal Government is done in other agencies, and I sup- pose that you could term a good part of that more basic research as anticipatory, at least in the broadest sense of the term. The National Science Foundation, the National Cancer Institutes and a number of other Institutes of Health are typical agencies which fund the basic research. We, of course, get many of the intellectual breakthroughs that allow us to understand the nature of the problems we face in the future or the nature of the solutions for those problems. We are going to have to deal with 10,15, or 20 years in the future. Mr. BLANCHARD. I am curious as to what you are doing and what you have in mind. I would assume if we have all of these different pollutants and the chemicals and drugs and the additives in our daily lives operating, all of which individually may be adjudged safe at low levels you run the risk of accumulating all of those together and it would be extremely hazardous. Theorizing, my chance of having cancer is much greater than my mother and my son's chances are probably greater than mine because of the accumulative effect. Are you into that type of situation? Dr. GAGE. Yes; we are. Your chance of getting cancer is about one in four. Your chance of probably dying of, cancer is probably one in seven. Environmental factors beyond your life style-factors such as smoking and nutrition, et cetera-really suggest that there are prpb- ably a host of environmental toxicants which may cause cancer or may contribute to the cause of cancer, and we are very much in the middle of that work. I think tO a very great extent that was the impetus for the passage of the Toxic Substances Control Act and the amendments to the Fed- eral Insecticide, Fungicide, and Rodenticide Act to make sure we keep under control as many of these human carcinogens and human toxi- cants as we possibly can. I would say we are right square in the middle of that activity. [The following question and answer were submitted for the record:] Question. You stated that the bulk of the more basic research is sponsored by other agencies. In recent years NIEHS has initiated a program that includes the development of short-term or screening tests, test validation, mutagenesis testing, etc., many of the same activities conducted by EPA's R&D program for Health Effects under Toxic Substances. In this area, are the EPA and NIEHS Programs similar or is the NIEHS Program a more fundamental basic type of research? How would one briefly characterize the relationship of these two programs? Do they fit together? Answer. The missions of the National Institute for Environmental Health Sciences (NIEHS) and the Environmental Protection Agency (EPA) are funda- PAGENO="0108" 102 mentally different. EPA's authority to regulate toxic substances is drawn from the Clean Air and Clean Water Acts, the Safe Drinking Water Act, the Resource Conservation and Recovery Act, the Toxic Substances Control Act. t~e Food, Drug and Cosmetic Act, and the Federal Insecticide, Fungicide and Rodenticide Act. Our health effects research is designed specifically to provide data required to meet our regulatory responsibiliites. NIEHS has as its central mission the conduct and support of biomedical research to identify, assess and prevent the adverse effects of environmental agents on human health. The principal recipients of the basic research findings generated by NIEHS are the regulatory agencies with authority to control the dissemination and use of toxic agents or the exposure of segments of the popu- lation to them. Thus, the orientation of EPA differs from that of NIEHS. While some aspects of our research and theirs may appear similar, both the Interagency Regulatory Liaison Group and the cross-agency toxics research ZBB found little evidence of duplication between these two programs. A report on the toxics cross-agency ZBB will be provided to the Committee by March 23, 1979. This report will offer a more detailed explanation of each of the Agency's roles in the overall Federal toxics research effort and the analyses and findings of the ZBB deliberations last summer. Mr. BLANCHARD. I have a lot of other questions that I would like to submit. Mr. AMBRO. I would like to go around and if we have time, we can come back. Mr. Bitter? Mr. RITTER. Thank you, Mr. Chairman. I would like to thank you, Dr. Gage, and your colleagues for providing this comprehensive report. I would suggest for the ease of filing and for going back to the report it has been my experience that an abstract is very helpful, something on a front page that takes up maybe two or three para- graphs and summarizes what you feel are the outstanding problems and opportunities facing the agency in this particular budget au- thorization process. Another small item of housekeeping, what is the percentage, or what are the percentages of intramural versus extramural research support that make up the EPA ORD budget? In other words, how much is done in-house and how much is done in the proverbial out-house? Dr. GAGE. If I can have 1 second here to confer. Mr. RITrER. I might add I am quite new to this committee, so if some of these questions seem overly general, please excuse the high level of ignorance I bring to the committee. Dr. GAGE. Just roughly, one-fourth of our total resources in this new budget-fiscal year 1980-will be used to support the in-house activities. This, Mr. Ritter, is the support of our headquarters staff and the 15 laboratories. Roughly, one-third will be issued through Federal procurement arrangements and will result in contracts primarily with profitmaking organizations. Mr. BITTER. That is basically with industry. Dr. GAGE. That is right. Roughly one-fourth will be going out into grants or cooperative agreements, and these are with universities or nonprofit research institutes. Finally, about one-sixth, and I hope I have been able to add these up correctly, will be transferred to other Federal agencies under interagency agreements whereby we use the personnel in these other agencies to conduct research for us. Mr. RITTER. Do you see these percentages as remaining relatively constant, going in either one or the other direction, or is there no sem- blance of movement discernible? PAGENO="0109" 103 Dr. GAGE. Well, the research personnel we have had available to us for the last several years has remained essentially constant, around 1,800. We have also seen during that same period of time roughly a tri- pling of our budget which means there has been a fairly massive shift away from support of in-house research to contract for research, or issuance of research grants under the private sector. This has been a trend and very frankly, with the very strong pres- sures to keep Federal manpower at the current level or even lower levels, I would see this trend probably continuing. We see a shift in- creasingly towards contracts and yet also, a fairly steady growth in grants as well. Mr. AMBRO. Would you yield? Mr. RrrEER. Surely, Mr. Chairman. Mr. AMBRO. Dr. Gage, in a couple of these areas we find in terms of net dollars there are decreasing amounts, say in water quality and in others. You also point out in your testimony that a number of these decreases result from not including the congressional add ons of pre- vious years. Is there a direct relationship between the diminution of positions a*id the reduction in the dollars without the add ens? Dr. GAGE. No. Mr. AMBRO. Do you follow me? Dr. GAGE. I think I follow you and I would say no. In general, we do tie together in our zero based budgeting process the level of people and the level of dollars in each level of our decision unit. and we have so many dollars and so many people. However, in the special instances where we gOt 1 year appropriations for special purposes we have decoupled that process so we do not take a congres- sional add on, bring some people to bear against that and then lop that all off and lose both the people and the dollars. Mr. AMBRO. So when you answered Mr. Bitter and said your person- nel remains about constant when you put so much emphasis, for ex- ample on health initiatives and health effects, and you shift consider- ,ably, more money to that area, does that mean that you just shift per- sonnel in EPA from one program to another? I know this is a sensitive question in a sensitive area, but we are dealing with very difficult topics which require a great deal of, it seems to me, expertise and background, and I just want to know if you are maintaining in-house levels of personnel and in some cases, shifting people who do not have the specific kinds of experiences that you want when y.ou are shifting moneys and making the policy statements that the shift of moneys indicates. Dr. GAGE. The pattern, Mr. Ambro, until the past year has been to try to reprogram people as totally as possible within the total com- plement of personnel slots. Mr. AMBRO. What is "reprogram?" Dr. GAGE. That is shift them from one area of activity back to an- other area of activity. In other words, there had never been a reduction in force taken by the EPA in any area in order to free up additional new positions in another area. This past year, we did make the decision to conduct reductions in force in three research areas which resulted in reductions in force in three research laboratories. One of those ac- PAGENO="0110" 104 tions is afready complete. The other two will be done within the next few months. In other words, we have finally gotten to a point that there is just no more resiliency within the organization to reprogram people from one activity to another activity, and what we are having to do when we make shifts within the program is literally fire some people from one area of low priority in order to hire people with the skills we need in another area. Mr. AMBRO. And you are doing that ~ Dr. GAGE. Yes. Mr. AMBRO. Thank you, Mr. Ritter. Mr. RITTER. I hope when you talk of reprograming you are talking about something other than reindoctrinating our personnel at EPA. I assume they are not indoctrinated like the "Moonies" or other cultists. Dr. GAGE. We tend to work with robots and it is quite simple. Mr. RIrTER. Seriously, technology effects language and we talk about people the way we talk about machines. I want to say that I share the concern of the gentleman from Pennsylvania, my distinguished col- league Bob Walker, about the idea of duplication in what is a massive public works effort, certainly one of the largest public works efforts, and I would hope that in this enormous dichotomy of responsibility between State and local and this agency and that agency, we do not lose sight of the fact that the kind of problems that Congressman Walker brings up are problems that perhaps research can help to mitigate. I, myself, have seen in my own district the intense competition for existing sewage facilities, the fact that there may be availability in one community and not availability in another community; the fact that there is political competition for these grants and there are special interests served by who gets them and who gets the con- tract, and I think this kind of overview of the impact of these kinds of grants could be an area where research can perhaps assist the public's knowledge of what some of these problems are and can per- haps assist in gaining a greater efficiency in the use of these billions of dollars of public funds. I also am concerned about the decision process that underlies the setting of standards. Obviously, research is one major part of that decision process and I was intrigued by the movement of the standard from 0.8 parts per million to 0.12 parts per million and I guess I am curious about what kind of sample numbers go into setting a standard, how many people are actually investigated in this medical sense. I heard you mention something about 6 and 20 and that did not sound like it had a great statistical base to it and I was curious as to how many thousands of people actually get investigated medically in the setting of such a standard. Dr. GAGE. It very much depends on the type of pollutant we are dealing with, Mr. Ritter, and on the amount of research resources that have been available and the type of research that has been conducted. When we are able to carry out successful epidemiological studies we may have sample sizes that run into the thousands of individuals who are observed in real life situations. However, because of the large num- ber of variables in real life situations it is quite difficult to identify on PAGENO="0111" 105 a one-for-one basis the relationship between observed effects and any one of the various pollutants to which the subjects may be exposed. Mr. RITTER. The cause and effect relationship? Dr. GAGE. That is right. If you just think very quickly about the problems we have in unraveling the many effects which may be caused by the many different air pollutants in any one of our major indus- trialized cities, you are able to see the type of situation we are faced with. We turn increasingly toward the use of clinical studies where you can expose individuals under very carefully controlled situations and monitor the effects very carefully, attempting to screen out to the maxi- mum extent possible all of the subjective factors. For instance, one of the confounding factors is that ozone itself is not an appreciable irri- tant, although it is a major constituent of other oxidants in the urban smog, that is, peroxyacetylnitrates (PAN) are much more irritating to tissue. How do you handle that? It is easier to handle that in the lab- oratory. You go in and expose the patients only to ozone and look at what changes the ozone makes in the pulmonary function, the blood chemistry, et cetera. Mr. RITTER. You have to do a great deal of extrapolation in those experiments because obviously you cannot subject human subjects to dangerous doses. Dr. GAGE. That is precisely the point, but that is not quite as difficult as it may seem. What we are focusing on is the extreme lower end of the effects level, Mr. Ritter. We are not concerned about the effects that might occur if the pollutants are allowed to rise up to a point where half the popula- tion would be crippled or would die. We are not determining the so- called LD50 (lethal dose-50 percent). We are trying to find out what is the lower edge of the effects range. We have used, up to this point within our own clinical laboratories, only healthy individuals. There have been several other studies in hos- pitals which have allowed the use of people who have had impaired pulmonary function, people who have had asthma or other types of respiratory problems in the past. It is difficult to get ethical committees to pass on the test procedures for working with impaired individuals. We are attempting to work with healthy asthmatics, if you will, in some of our studies to try to look at the range of variability in the populations we are studying. Mr. RITTER. Your comment on these effects of different pollutants; sometimes I get the impression that you know we have got on our hands a rampaging elephant and what we are doing is sort of grab- bing it by the tail and, of course, we cannot control it really and we pull off its tail thinking well, we got one of them out of there and they will all go away. The percentages of people that are actually affected in your test studies; obviously not everybody is affecthd in the test group and there is a certain threshold percentage beyond which a certain dosage is all of a sudden considered dangerous to health. What kind of percentages are those? Dr. GAGE. I really am in no position to speak in any kind of, a gen- eneral sense about that. If you have some specific questions on mdi- vidual pollutants, we can provide that. PAGENO="0112" 106. Mr. RITTER. Let me talk about, for the monent, particulate pollution which is intetesting to me for a number of reasons. What kind of percentages were involved, for example, in the coke oven standard . setting for particulates or, for example, some of the other gaseous pollutants that might have been given off in that process? Dr. GAGE. If I recall that particular situation-and if I am incorrect, I will submit a corrected version for the record-the concern with coke oven emissions was for the polycyclic organic materials which were attached or involved with the particulates. These are human carcino- gens and what we were able to turn to in that particular case for our data were occupational exposures of workers who actually had labored for some time on the tops of the coke batteries. There the incident of lung cancer rates was so extraordinarily high that you were talking about not a large number of those workers, but something like 60 or 70 percent of those workers who did have lung cancer. The connection with the exposures there to the emissions from the coke batteries was really quite extraordinary. We did not have control over exposures to the workers themselves. That falls under the OSHA. But usng very good extrapolation models, we were able to use those kinds of exposure results to get some sense of what would be the effect on the people living outside of the coke batteries in the general population. Using those kinds of scaling rela- tionships, we then devised risk estimates to the populations in the vicinity of the coke batteries. Since they are distributed throughout a number of the fairly highly urbanized areas throughout the country, another number we came up with was something like 17,000 people in the United States who were at risk at a high enough level that we felt we had to take some actk~n under section 112 of our Clean Air Act, which requires us to bring1about the control of hazardous air emissions. Each case is somewhat different. In that particular case, we had very good epidemiological data which guided the POM's-polycyclic organic matter and in 9any other cases, we have to turn to other types of correlation. / Mr. Rirrr~. Are the particular correlations good, for example, from stack gases. What kind of percentages of people whom you studied are affected? I am just trying to get a handle on the whole standards thing be- cause it is very, very meaningful to so many of our industries in this country; to a whole way of life. Somebody mentioned economic impact of these deci&ons and obviously, some of your legislation does not allow for this, but there is a gross economic impact on an entire. community, a health impact I might add, when an entire community loses its source of employment. I would say the depression and mental health factor of people who have been working for 15 or 20 years is enormous. ~The following question and answer were submitted for the record.] Qu~$tion. Under which legislation can economic impact be considered in regu- latory decisions and to what extent? What laws allow only the consideration of health effects? Answer. The Statutory provisions in the attached list do not explicitly permit the `agency to consider the economic in~uact of regulatory action, although `agency interpretation does permit some consideration of costs where noted. In our other regulatory actions, including all actions under the Toxic Substances Control Act, the Federal Insecticide, Fungicide, and Rodenticide Act, the Noise Control Act, and the Marine Protection, Research, `and Sanctuaries Act, we may consider economic impact, `and we do. PAGENO="0113" 107 FEDERAL ENVIRONMENTAL, SAFETY, AND HEALTH STATUTORY PROVISIONS WHICH DO NOT EXPLICITLY PERMIT THE REGULATORY AGENCY TO CONSIDER THE COST OF REGULATION (ENVIRONMENTAL PROTECTION AGENCY Responsible Statute and provision(s) agency Description Clean Air Act, 42 U.S.C. 1857, et seq: Secs. 108, 109 EPA Sec. 110 EPA Sec. 1122 EPA Federal Water Pollution Control Act (Clean Water Act), 33 U.S.C. 1251, et seq: Sec. 304(a)3 EPA Sec. 307(a)3 EPA Sec. 307(b)2 EPA Sec. 3112 EPA Sec. 3122 EPA Ambient air quality criteria and standards. Emission limitations for State implementation plans (implementing secs. 108, 109).1 Hazardous air pollutants. Water quality criteria. Toxic pollutant effluent standards. Pretreatment standards. Discharges of oil and hazardous substances. Marine sanitation devices. Sec. 403(c)3 EPA Sec. 404(c)3 EPA Resource Conservation and Recovery Act, 42 U.S.C. 6901, et seq:. Sec. 1008 EPA Sec. 3001 EPA Sec. 3002 EPA Sec. 3003 EPA Sec. 3004 EPA Ocean discharge criteria. Dredge or fill disposal sites. Solid waste guidelines. Hazardous waste list and hazardous waste characteristics. Standards for generators of hazardous wastes. Standards for transporters of hazardous waste. Standards for treaters/storers/disposers of hazardous waste. Sec. 4004 EPA Safe Drinking Water Act, 42 U.S.C. 300 et Criteria for sanitary landfills. seq.: Sec. 1412(b)(1) EPA Sec. 1421 EPA Recommended maximum contaminant levels. Regulations for State underground injection control programs. 1 These requirements usually are imposed by States. The States have the authority to allocate the necessary amount of pollution control. Consideration of cost is precluded only when emission reductions by a particular source are necessary to meet standards. 2 Agency interpretation permits some consideration of costs. 3Statute lists criteria for regulation; costs or technology not among criteria listed. Dr. GAGE. That is right, and that certainly has to be a factor in the overall approach that we take toward the devising of pollution con- trol strategy., In the case of particulates, I would have to supply a statement for the record which would synopsitize the status of our knowledge on particulate pollution. Mr. RIrr~R. Is there any action between EPA and its standards set- t.ing devices along with other agencies to begin the consideration of economic impact or some of the other impacts? Dr. GAGE. One of the results of the establishment of the Interagency Regulatory Liaison Group this past year has been a number of joint efforts undertaken by EPA and OSHA, in particular, to look at the economic impact of applying both occupational environmental con- trols at the same time to that given industrial sector. I think that is a very wise thing to in that there could hypo- thetically be the case where something which EPA would require could cause greater threat to the workers of vice versa, something that OSHA. would require could cause greater effect to the surrounding environment. So, first of all, we are trying to get our control ap- proaches on the same route and then look at the economic impact of those approaches under the same route. Mr. RirreR. I think that would be very good for the overall health of our Nation. I have one quickie, that is on the materials. What exactly is the materials functions-materials policy function in this subcommittee going to be, or what is it, Dr. Reznek? 43-778 0 - 79 - 8 PAGENO="0114" 108 What is EPA's relationship to materials at this point? Dr. RDZNEK. The industrial processes, from,extraction all the way to processing, must deal with a variety of environmental problems and a variety of regulatory requirements. Supporting each of those regu- latory requirements is a research effort. For example, in extraction and processing, the Agency sets air pollution emission standards and re- search programs support the development of these regulations. Re- search documents the capability and cost of controlling the emissions of both air and water pollution. The disposal, storage, and transportation of hazardous waste- waste which is associated principally with the processing of ma- terials-also comes under new regulations, the Hazardous Waste Provisions of the Resource Conservation and Recovery Act. We will be doing research in the area also on the cost and capabilities of tech- nologies for dealing with hazardous solid waste. [The following question and answBr were submitted for the record:] Que8tion: The ORD budget request contains $8,148,000 for Environmental RD&D un:der the Resource Conservation and Recovery Act down from $8,148,000 In FY 1979. How much of this is directed at municipal solid wastes? How much is directed at hazardous wastes in total, at cleaning up existing hazardous wastes sites, and at developing improved methods for new land disposal sites? Given the overall concern for hazardous wastes, why is there a decrease in Solid Wastes-Public Sector Activities? Answer: Of the $8,143 million in the budget request, 20% or approximately $1.6 million is directed at municipal waste. The balance, or approximately $6.5 million, is applicable to hazardous wastes. Of the $6.5 million approximately $4 million Is directed towards cleaning up existing hazardous waste sites and im- proved methods for new disposal sites. It is pointed out that some of the research for improved methods for new disposal sites is applicable to both municipal and hazardous wastes. Research associated with hazardous wastes has not suffered as a result of the small reduction in solid waste research. In fact, the amount of research associated with hazardous waste has increased approximately $500,000 over that contained In the FY 1969 budget; however research In resource recovery has been decreased a like amount. Finally, the Agency has two authorities for regulating commercial products on the basis of hazard, an older, very large program on req- ulating pesticides and the newer program on regulating toxic substances. Mr. RITTER. So the materials effort is basically a review of the ex- tractive industries and also of toxic chemical industries themselves - which clasify as materials and perhaps not organics, is that right? Dr. REzNEic. That is correct. There is major policy review underway nf the non-fuel mineral industries in the United States. Mr. RIrrER. So the whole question of environmental control within say the steel industry will now be isolated a little hit more in EPA with this materials office? Dr. REzNEK. The research support will be in one office. The Office of Air, Noise, and Radiation will regulate air pollution problems under the Air authority. The Office of Water and Waste Management and its Solid Waste Office will regulate the disposal of hazardous solid waste. We have centralized the engineering support and the health support into one organization, the Office of Research and Development; ORD looks at the way in which any particular industry operates and the PAGENO="0115" 109 types of controls that can be applied, and the air problems in relation to water problems. Mr. RITTER. So you are looking at more specific industries? Dr. REZNEK. Yes; the organization of the Office of Energy, Min~ erals, and Industry is industry by industry. Mr. RITTER. Thank you. Mr. AMBRO. Thank you, Mr. Ritter. I do not mean to stifle anyone, butT did w~tnt to go around and make sure everyone had the oppor- tunity to get their questions in and we will do it once more if we have time. I am told we might have to suspend, although that is not all sure. If we do, of course, we will break for that. I wonder, Dr. Gage, if you would be kind enough to accept written questions and respond in written answers for the record in order to round it out? Dr. GAGE. Certainly we would. Mr. AMBRO. Just one more point. We have received a few budget justifi~ation books, but not enough to go around, Can we get another 10 copies? Dr. GAGE. I believe we can. It was a matter of getting them out of the printer at this point. Mr. AMBRO. As I understand it, the 1979 budget was $334,034,000. We are going up to an overall of $368,741,000 or about an increase of $34.7 million, correct? Dr. GAGE. Yes; including prorated agency support. Mr. AMBRO. The major shift would be an increase in health effects and a decrease in a couple of other items which I find most significant. I recognize that under certain laws the Administrator cannot be con- cerned with the economic impacts in developing health standards, but the law does not say, and maybe I can have Dr. Reznek's attention with respect to this, the development of and research in technologies to remedy the impact cannot be emphasized. We now see a cut in control technology. An awful lot of us come from local government and those municipalities do have the financial responsibility, even though they have contributory funds from the Federal and State level, for sewage treatment and clean drinking water, and it seems to me that with the great emphasis that we have on identifying contaminants and analyzing and monitoring contami- nants, we cannot afford a reduction in our efforts to develop remedial technologies. - [The following question and answer were submitted for the record :j Question~ In the area of organics In drinking water, is it correct that the FY i980 budget request includes an additional $5 million for health effects research to identify contaminants and only an additional $1 million for drinking water treatment and groundwater protection? Answer. The $5 million increase requested for health effects research In drink- ing water Is part of. a Public Health Initiative to expand our research In several critical areas. We know that over the long term, information on the health effects of organic in drinking water will be one of our most Important research needs. The funds are requested to expand our health program, with a strong emphasis on organics, Investigating the association between contaminants In water supplies and health risks such as that of cancer and cardiovascular disease. The $1 million increase requested for drinking water treatment and ground- water protection is to continue demonstration of technology for potable reuse of wastewater which was initiated In FY 1979. The information expected from this effort will ultimately contribute to the preparation of safe and acceptable PAGENO="0116" 110 drinking water from wastewater, and thus to a national water conservation effort. The remainder of the treatment and groundwater program will be main- tained essentially at the present level. Our current knowledge about ground- water contamination is so limited that our research must concentrate on informa- tion gathering and analysis. As we learn more about the nature and extent of the problem, we will reevaluate our resource needs in this area, so that we can move quickly to establish the scientific basis for methods to prevent ground- water contamination. Mr. AMBRO. As I understand it, Dr. Reznek, the industrial compo- nent in control technology develops and evaluates technologies, et cetera, and the urban or public sector research area develops tech- nologies to improve municipal waste-water systems and determines suitable means of managing urban runoff, develops technologies to decontaminate drinking water supplies, and develops technologies for toxic waste disposal. Well, the question is, in your opinion do you have sufficient funding and manpower to meet the public sector mandate? Dr. REZNEK. Mr. Ambro, the part of the program I currently administer is the part associated with industry and energy; I do not have the municipal part. I would ask Dr. Murphy or Mr. Riordan to respond. Mr. AMBRO. Either one. Dr. MURPHY. I will try first. Could we do more? Certainly, we always could do more, but we have to allocate our budget in terms of competing projects and what resources are available. One fact to consider with regard to sewage treatment research is that development and demonstration of new sewage treatment sys- tems is not limited to the budget within ORD. Indeed, the Congress has set aside a certain amount of construction grants money for this purpose. Er, AMBRO. Does that include tertiary treatment? Dr. MURPHY. if required by water quality standards, it does. Any treatment process is eligible if it meets the criteria set to determine innovativeness. Mr. AMBRO. But it does not now? Dr. MURPHY. I think the regulations as written now do not provide for that. Mr. AMBRO. Well, I do not know that I should shift from Dr. Gage to you with respect to this business of a balance between the escalating numbers of new contaminants that we are identifying through in-S creased health effects research and the moneys required by local mu- nicipal managers, raised for the most part by impacts on a regressive property tax rate, to remedy that which we daily find is carcinogenic or polluting or toxic or what-have-you. Now, do you not think that is a most significant area where we should have a great deal more emphasis than we have, or is that ques- tion loaded? Maybe Dr. Gage is better qualified, or I should say equipped, to handle the policy aspect of it because I recognize, Dr. Riordan, you do not have the money, you cannot do very much about it, but you do have the money in terms of Dr. Gage's testimony-you have a man- date and it seems to me that we should be able to answer the question, whoever would like to try it. . PAGENO="0117" 111 Dr. MtJnPHY. Mr. Chairman, I think part of the problem is how much it is a research versus an operational problem. We are in the process now of trying to get a hold of the toxics problem; what toxics are out there, their potential impact, how effective treatment facilities are in handling them. A great deal of toxics can be removed from the water stream by traditional secondary treatment. We have underway a number of short-term research projects in cooperation with our program office colleagues trying to get ahold on how much and which ones. I think we mentioned before that the data are highly variable. The problem is severe in some areas, but it becomes difficult to make gen- eralizations at the national level. Before we would want to embark on a major and costly research and development program, we want to have a better handle on what the problem is and where the payoffs may be. That is where we are focusing our attention right now, Mr. AMBRO. Suppose you are now in the process of funding dem- onstration programs for the removal of industrial organics from drinking water, which you are. Dr. MURPHY. Yes. Mr. AMBRO. Aeration and carbon filtration and things like that. Dr. MURPHY. Yes. Mr. AMBRO. How do you move from the empirical evaluation of that program to providing that which you develop to localities and to the public sector as we define it here? How does that become available to them and you might weave into that answer what happens to the studies such as the waste fuel studies or the biomass studies, but are they available to even the private sec- tor to take advantage of in terms. of economies and efficiencies and things like that? How does that work? Dr. MURPHY. The results of studies are made widely known, We have a limited number of people within EPA's Office of Research and Development and cannot literally deliver to all of the potentially in- terested users of this information so we use ~everai mechanisms. Among others we tr,v to communicate through the established con- sulting engineering community, who are constantly at our door finding out what information we have and providing expert consultation to the localities. `%~Te have a specific effort, the Technology Transfer program from municipal waste water, where we set aside a certain amount of re- sources and people to spread the word both to consulting engineers and to local municipal officials. This has traditionally focused on waste water treatment, hut is being expanded into other areas. Dr. GAGE. Under the Clean Water Act of 1977, we were required to set up a clearinghouse to make available information on the inno- vative and alternative treatment methods for waste water systems. I offer this as one possible model for future efforts in the area of disseminating drinking water treatment information around the coun- try. We will be doing those kind of things in a varied and ad hoc fashion anyway; possibly a clearinghouse might be of some real use. Mr. AMBRO. Well, precisely, if you identify a contaminant and if a State health director then decides that the existence of this contami- PAGENO="0118" 112 nant in some parts per million has deleterious health effects, they then decide to close a variety of number of wells, and we are going to hear about this in these hearings. Are you suggesting to me now that the R. & D, that you do in other parts of the Nation and the. technologies you evaluate and determine are effective in re.movin~ that contaminant., that knowledge is through some easy process available to people on the `local level who are responsible for assuring clean drinking water? How does that work? You know, if a mayor hires a consulting engi- neer, he can devise all manner of plans to meet the. iieed, but is there an easy way to ask EPA for the benefit of their wisdom, their research and their knowledge? Dr. MURPHY. Certainly there is. We have mentioned some of these mechanisms, including the technology transfer program and our clear- inghouse. One of the difficulties is that the situation varies from lo- cality to locality. You cannot pick up a study from one are'a and take it and apply it in another area without using some technical judgment. Here is where the consulting engineer serves a very useful purpose. In some cases, the data are more easily applied over a broader area than others, but in other cases, one has to consider the local condi- tions-the flow of the waste, the nature of the waste and other condi- tions that are locally specific. Mr. AMBRO. Well, I am not going to pursue this at the moment be- cause I want to yield to Mr. Brown for a line of questioning, but maybe if we have a few seconds we will get back to it because IL am most inter- ested in the widening gap and thee conomic impacts on municipal managers and local taxpayers of the increasing identification of new contaminants, but that does not mean we should not clean it up. What it means, I hasten to say, is that I think we should have a much stronger effort at his level where we do have the resources or should have the resources to develop the technologies necessary to take remedial action. Mr. Brown? Mr. BROWN. Thank you, Mr. Chairman. I wanted to commend Congressman Ritter for the line of question- ing which he had initiated with regard to the research methodologies and validity and the connection between research results and regula- tory practices. I do not know to what extent he is aware of it, but other members of the subcommittee have been interested in some analysis of this kind of question and I trust that the subcommittee will be able to get into it in greater detail as we emerge from the pressures of the authorization hearing because these kinds of questions are `being asked more and more frequently by the public and by, of course, Members of Congress who may not have the opportunity to delve into the re- search as deeply as members of this subcommittee do. There are a number of things, Dr. Gage, in your presentation which I am very pleased with and I want you to be aware of that-the general increase in effort on the health issues, the public health initiative I think is highly desirable. Your move toward improving the strategic planning and analysis capability is a matter which we have probably commented on ad nauseam in the past and we appreciate the fact that you are moving strongly in that direction. I still feel and I think that other members feel concerned about what we might call the general problems of coordination or linkage between research and regulation, research in this agency and research in other PAGENO="0119" 113 agencies, and the degree to which we have sought to broaden the in- volvement of other levels of government in the collection and analysis of the data that might be useful in our overall effort. Let me be more specific. Is my understanding that HEW has under the mandate of the Secretary developed a new national toxiocology program which involves the various agencies in HEW that have re- sponsibilities in this area? Is there a linkage between the toxicological research being done in EPA and the planning and conduct of toxicological investigations and the use of scarce resources for that purpose in HEW? Dr. GAGE. There is a very close connection between our activities in EPA and the new, so-called national toxicology program. The EPA has a seat on the executive board of the national toxi- cology program as do the heads of the Occupational Safety and Health Administration, the Food and Drug Administration and the Commis- sion for Consumer Product Safety. This program was devised within the Department of Health, Edu- cation, and Welfare to try to make more of the very considerable acti~- ities of the Department more responsive to the need for better scientific information by the regulatory agencies. We are going to be working quite closely with the natiQnal toxi- cology program to set the priorities for the chemicals which must be subjected to the chemical bioassays, and also the priorities for the vali- dat~on of screening methods which might give us new techniques which are more cost effective and more rapid in determining the toxic ef- fects of chemicals withoi$ having to go through the whole animal test, which takes 2 to 3 ye~rs. We also had a very rigorous inspection of the toxic research con- ducted not only by the j!our regulatory agencies, but by the three Na- tional Institutes of Health during this past summer, as I mentioned in my opening statem,ènt. We scrutinized our work very carefully first, and under OMB's watchful eyes scrutinized our work again and also the work of the National Institutes of Health. I think what came out of that effort was a much better under- standing of what we can do jointly. Very frankly, there was a much better appreciation on the part of the Health Research Institutes that our needs in the regulatory programs are indeed, massive and nondis- cretionary; that we have to have research results by a certain date. In many instances, a date is set by the Congress or the court in imple- menting the laws passed by the Congress which is nothing we can de- lay, or else the Administrator is hauled into court for contempt. This is going to probably increase adjustments of some of our na- tional research priorities to focus more on research to provide better answers to the questions posed in the regulatory process. Mr. BROWN. I was pleased to note the effort to establish the national toxicology program. It is an interesting exercise in organizational co- ordination within a single department and with some attention to functions outside of the department and it includes a planning process and a review process and the allocation of resources to the various agencies. Does your participation go so far as to identify some EPA resources that are made a part of the overall research program? PAGENO="0120" 114 Dr. GAGE. At this point, the resources which are being used by the national toxicological program are completely under the HEW bud- get. We will consider in the future contributing to that program after we think we have given it :a fair chance and see what it does. We are working jointly with the Food and Drug Administration on several efforts; the National Center for Toxicological Research in Arkansas and our new neurotoxicology research program, and in these areas we feel very comfortable in contributing additional dollars. Mr. BROWN. Well, I think that the efforts being made to improve co- ordination, represented by the interagency regulatory liaison and the national toxicology program and so on are highly commendable and I hope we can follow the progress and evaluate the degree to which they are succeeding or failing, as the case may be. [The following question and answer were submitted for the record:] Questio~v. To what extent is FDA supporting the Neurotoxicological Research Facility planned for RTP in North Carolina? How much of the fiscal year 1980 Public Health Initiative applies to this facility? Will the projects at this facility be jointly planned'? Is there a mandate that EPA provide $4 million of support at the National Center for Toxicological Research in Arkansas? Does EPA control how these funds are spent? Answer. The Food and Drug Administration (FDA) and EPA have jointly ini- tiated and are establishing the Neurotoxicological Research Facility at Research Triangle Park, North Carolina. The Facility will combine the limited resources in funds and research personnel currently available in both agencies and will be co- sponsored by both FDA and EPA. This cooperative action is a direct outgrowth of deliberations of the Interagency Regulatory Liaison Group (IRLG). FDA has provided $600,000 and five man years for establishing and operating the Facility in fiscal year 1979. Approximately $460,000 and five man years will be made avail- able by FDA for the Facility in fiscal year 1980. The EPA contribution for the Facility is $1.2 million and 10 man years in fiscal year 1979, approximately twice that amount of funds and 10 man years will be made available in fiscal year 1980. The fiscal year 1980 EPA Public Health Initiative includes $1.5 million and two man years to be provided to the Neurotoxicological Research Facility for short- term neurological and behavioral methods development. All work of the Facility is jointly planned by FDA and EPA. A research pro- gram has been designed by scientists from each agency to meet common research needs. Yes, there is a mandate from Congress to provide a continuing funding level of $4 million to support the long-term research at the National Center for Toxi- cological Research (NCTR) in Jefferson, Arkansas. In a letter dated March 11, 1974) the Chairman of the House Committee on Appropriations declared the "Realistic testing" at NCTR to be of "highest priority" and denied an EPA re- quest to adjust its budget through a reduction in the amount appropriated for NCTR. The $4 million is provided as support of the base program for NCTR. EPA control of use of the funds is exercised through equal representation of EPA with the Food and Drug Administration on the NCTR Policy Board. The Policy Board advises the Center Director. Specific research to be funded is also nego- tiated by an EPA research project officer in developing annual interagency agree- ments for transfer of the $4 million to FDA and for fulfilling specific research needs. May I go on for a moment to the general issues of research method- ologies, I guess. You made reference to the growing importance of clinical studies and the focus on clinical studies because of the difficul- ties involved in epidemiological analysis, and so on. You did not point out any weaknesses in clinical studies as modes for providing answers to the problems of pollution effects on individuals. Would you care to indicate some of the weaknesses in this approach? PAGENO="0121" 115 Dr. GAGE. Well, I believe I did, at least in passing in one of my comments to Mr. Ritter and that was that we have been able to work at this point only with healthy individuals. Yet, at least the Clean Air Act very explicitly indicates we are to provide protection for the most vulnerable parts of the population as well. Determining how those more vulnerable parts of the population would respond to different air pollution represents a very real research problem that we have not been able to master in the clinical area as well as we would like. I do think that we are going to be recommitting ourselves, with this public health initiative, to improving our efforts in epidemio- logical studies. After all, that is the real world and if there are effects there singularly or in combination we ought to see them out there. This is sort of the ultimate and we need to improve those efforts. Mr. BROWN. The question that comes to my mind in a discussion of clinical studies is represented by the polycyclic organics you me~i- tioned. There are carcinogens. The normal period for a cance.r to mani- fest itself is long and indeterminate. It may be 10 to 15 years, or longer in some cases. You have a real problem in doing clinical studies to de- termine what the effects, human health effects, of say exposure to a low level of polycyclic organics would be. First of all, you probably could not do the experiment. Dr. GAGE. We would not want to do that. Mr. BROWN. So you cannot take tile clinical approach to that kind of problem. Dr. GAGE. That is right. Mr. BROWN. Yet, you mention that we have coke oven regulations based upon some studies that indicate there is a population at risk of 17,000 and on the basis of limited occupational epidemiological studies indicating there is a high potential for cancer. There is also a high potential for cancer from smoking pipes, cigars, and cigarettes and the question arises, how do you relate these risks? Is a concentration of polycyclic organics that has an estimated im- pact on 17,000 people and will take say $1 million to correct; are we justified in mandating that $1 million, when we do not mandate any- thing for say the 170 million or whatever the number is of people who are exposed to cancer from some other source and which may also be polycyclic organics, as a matter of fact? Now, that is a hard question to answer, but basically I am focusing on the risk assessment and the policy aspects of making these kinds of decisions. Dr. GAGE. I think this is the heart of it; the most difficult problem we face in EPA today. If you look at the several handsful of risk assessments we have completed over the last 2 years, you will see that the risk factor varies from 1 in 100 to 1 in 100 million in terms of lifetime risk of getting cancer. You also see that the exposed popula- tion may vary from a few pesticide applicators to some 200 million Americans in other instances. Trying to make sense out of what is the most intelligent public policy to exercise in a given time is a very difficult problem. We are attempt- ing to at least approach these risk assessments with as much intelli- gence as we can. We are just establishing a new office of Health and Environmental Assessment which will include some of our cancer assessment group PAGENO="0122" 116 which has been operating for the last several years in the Agency and our Environmental Assessment Office which has been preparing the criteria documents. We hope to bring some uniformity in these risk approaches and make sure we ask ourselves all the tough questions we can before we put the risk assessment documents forth as documents on which very highly impacting public policy decisions must be made. Mr. BROWN. Well, I am not discouraging this. I am encouraging it. I am pointing out the kind of simple lay approach that a lot of people are going to take and wonder if we are doing the right thing, includ- ing some very simple lay people on this committee I am afraid. Getting to the question of epidemiology for a moment, I am con- cerned that we are not providing research networks, and that includes some of the elements best able to give us integrated epidemiological data. For example, we have in the priyate medical profession and say local public health departments, a vast amount of data with regard to the health of the population in a given area. What they generally lack is first, accurate measures of exposure which research ought to be able to provide and as an example, you held recently a conference on individual dosimeters which is the ideal direction to go to begin to give us adequate data on exposure to a large population in a given area and also to correlate individual exposure with centrally measured indexes of the level of pollutants so that we can have that aspect of the epidemiological data base. The other aspect is the health effect on individuals and what you need as, for example, in the coke oven thing is a large amount of data on how many noncoke oven workers who may be at risk have actually deveolped cancer. I did not hear in the question and the answer which you gave to Mr. Bitter whether or not there actually was such data, but it is con~ ceivable that it exists or that if it does not exist, it could be collected fairly easily through the efforts of a local public health department. the county health agency, for example. I mention these to illustrate the importance of developing these linkages if we are going to have a national epidemiological program and I ask you only to comment if you see that I am seriously ofF base in thinking that this is a logical way to proceed. Dr. GAGR. I will only comment because I think you are going down the right track here very definitely. We appreciate your participation on the personal dosimeters, Mr. Brown. I would ask Dr. Murray to speak on what I think is an exciting develonment that has occurred during the past year. We supported some legislation that went through the House Com~ merce Committee reauthorizing the Public Health Act and helped get some additional language written into that act to hrin~ the very considerable health data base of the Department of Ilcoith, Educa~ Hon and Welfare to focus on these environmental nrohlerns. rThe following question and answer were submitted for the record :1 Question. What specific language was added to the Public Health Act to bring the health data bases of HEW to focus on environmental problems? What Public Law are you referring to? Identify the primary data bases at HEW that can provide input for addressing environmental problems. PAGENO="0123" 117 4riswer. I am referring to provisions of Public Law 95-623 related to the em' vironment and epidemiology. With regard to the Public Health Services Act, the language has broad implications to the design and coordination of statistical and epidemiological systems within several agencies, including the Department of Health, Education and Welfare, and EPA. In summary, the language to which I referred addresses approaches for understanding the relationships between environmental factors, human activities and diseases, using statistical and epidemiological tools. We in EPA, of course, have major concerns in this area. HEW has a number of data bases which can be brought to bear on the problem, data obtained by the National Center for Health Statistics as a notable example. In April of last year, I testified before the House Subcommittee on Health and the Environment on points in the legislation involving EPA. A major one, for example, concerns a cooperative effort to determine the costs of diseases to as- sure an effective program for protecting health. We In EPA support the princi- ples of preventive medicine as a means for protecting health from environ- mentally related diseases. We welcome joint efforts among the agencies having mutual concerns, and will strengthen our existing cooperation with HEW to implement this legislation as far as possible. Mr. BROWN. May I say before he starts that I am posing this area in distinction to the clinical area. We need both very badly, but need them within an integrated framework that gives us a basis for policy judgment. Dr. MURRAY. I am very interested in the clinical work. Certainly, the clinical work will give us a pretty good indication of acute effects. The chronic effects you mentioned, in terms of coke oven exposure, is best determined by epidemiological studies, preferably retrospective studies You will be interested to know that one of our physician epidemi- ologists, located at Cincinnati, is spending a good deal of his time rela- tive to diesel experimentations in determining what other organiza- tions have developed data concerning diesels and a cancer index. [The following question and answer were submitted for the record:] Question. What are the regulatory time frames or deadlines that affect EPA'S research on the health effects of diesel exhaust? Is the EPA research being co- ordinated with health effects research on diesel exhaust at DOE? Is it possible that research projects of different duration (short-term versus long-term) will yield conflicting results? Answer. General Motors tells us that they are planning to make large financial commitments to diesel automobile engine production by the end of 1979. ThIs time scale, they say, is being forced on them by the fuel economy laws and regulations. This Implies that EPA may have to make an initial regulatory judgment on die- sels in late 1979, based on the health effects Information then available. The health effects research on diesel exhaust is being coordinated with DOE. Their health effects research is in the planning phase and will be getting under- way shortly. The DOE/EPA coordination has been occurring both at the Wash- ington planning level and between the actual researchers. It is possible that research projects of different duration (short-term versus long-term) will yield conflicting results. Such conflicts occur, quite often In en- vironmental effects research where the threat to public health comes from wide.. spread exposure with a relatively low individual risk. Epidemiological studies are very expensive so that is why we want to find out whether other data bases are available. We are conceriied that we have only 16 epidemiologists. We have several vacancies and are making considerable effort now to fill those vacancies because we feel a need for a more vigorous approach to epidemiology. Mr. BROWN. Well, I understand there are shortages both of epidemi- ologists and toxicologists and in some cases, even medical doctors; med- ical doctors who have an interest in the type of research you need, but that is a broader problem we can explore more fully later. PAGENO="0124" 118 I have a feeling I am taking more time than I should, Mr. Chairman, despite the interest I have in this area and I will yield to my colleagues Mr. AMBR0. Thank you, Mr. Brown. I said at the outset, Dr. Gage, that we would go to conclusion here if that is all right with you to spare us both the meeting tomorrow at 4 o'clock. I do not mean this to be a test of endurance. If you would like to break for a couple of minutes and come back, that is all right. If you want to, we will go on. Mr. BLANCHARD. Mr. Chairman, I have a meeting at 4 o'clock today. Mr. AMBRO. That is different. That is a planning session. I was talk- ing about the meeting scheduled with Dr. Gage tomorrow. Dr. GAGE. We are here at your disposal, Mr. Chairman. Mr. AMBRO. Want to break for 5 minutes? Dr. GAGE. We can continue. Mr. AMBRO. You mention that you worked with 0MB and developed a zero based budget which is Mr. Blanchard's specific area of expertise. You have moneys, though, coming in from other sources that are not specifically highlighted here. For example, does not the National Can- cer Institute provide som.e moneys? Dr. GAGE. Yes; in this year's budget the National Cancer Institute has committed an additional $15 million to be directed toward helping us in the area we were just talking about, increased support in the area of cancer epidemiology, but the bulk of the effort will be focused toward studying the way in which chemicals move through the human body and are transformed by our various organs into different chemi- cals and therefore, eventually to cause toxic effects within the human organs. NCI does have a very excellent research capability and we are very pleased. [The following question and answer were submitted for the record:] Question. Why was the special financial arrangement established with only NOl and not the other health research Institutes such as NIEHS and NIOSH? Would a similar arrangement with them be desirable? Answer. One major focus of the cross agency toxics research ZBB, in which EPA, FDA, CPSC, OSHA, NIOSH, NIEHS, and NOl participated with the Office of Management and Budget last summer, was the interface between the basic health research institutes and the four agencies authorized to regulate toxic sub- stances. The view was expressed that to the extent that the basic research organi- zations can provide certain types of health data to support regulatory agency con- tz'ol strategy development, the regulatory agencies will not have to develop basic health effects capabilities of their own. As a consequence, relatively more regula- tory dollars and personnel can be devoted to sound standard setting than to more basic health related research. The outcome of the cross agency process was a ZBB ranking of the toxics re- search conducted by the seven participating agencies. Portions of NCI's basic science program were ranked relatively lower than other research, primarily be- cause the regulatory agencies did not find those products useful to them in either developing or implementing control strategies. As a result, a more direct financial arrangement between NCI and EPA appeared to be one mechanism which would promote a more effective Interface. NOl will devote the majority of the $15 mil- lion identified to the study of interspecies relationships of metabolism, pharma- cokinetics and toxicities. This is an area in which NOl possesses expertise, and one in which the products will be highly useful to EPA. Although such an arrange- ment exists only with NOl, if it proves constructive to both agencies there is no reason why similar agreements could not be effected between other agencies. An information paper on the cross agency toxics research ZBB will be provided to the Committee by March 23, 1979. This document will offer a more detailed explanation of the process and will discuss in more depth the genesis of the arrangement with NOl. PAGENO="0125" 119 Mr. AMBRO. How much more money comes from these kinds of sources that we do not see directly here? Dr. GAGE. That is the primary one. We are the source rather than the sink of such funds. We have the interagency program. We provide $4 million to the National Center for Toxicological Research which, in the main, is supported by FDA. We are pleased to have some of the other agencies contribute. Mr. AMBRO. Can you estimate the real increase in this budget ad- justed for inflation?. Dr. `GAGE. Probably somewhere between 3 and 4 percent above Fiscal Year 1979. The increase is just around 10 percent and scientific research is run- ning at a minimum of 7 percent inflation. In some instances with very high costs in some areas, the inflation rate has run to 10 percent or higher. So just conservatively, I would say the difference between our 10 percent increase and cost of adjustment of 7 percent would come out about 3 percent net. Mr. AMBRO. So, for those segments of the budget where there is an increase that would follow through, and in those segments of the budget where there is a decrease, the decrease is considerable. Dr. GAGE. That is right. Mr. AMBRO. Getting back to health effects research, when do you pro- propose that we will have a good ongoing program under stable leadership? Dr. GAGE. Well, if by that you mean when we will have the new Deputy Administrator for Health Effects, I have been very busy re- cruiting for that particular position since Dr. Barth, who was the Deputy Assistant Administrator, left our organization on an assigfl- ment out of Las Vegas. I think that within the next 2 to 3 months I should have that selection process completed. Dr. Murray has been selected as the Deputy in that area and his papers-and that, Mr. Chairman was back about the first of Septem- ber-were sent directly to the Civil Service Commission. They have been reviewed over there since then but we are operating on the basis that Dr. Murray will continue in that position, subject to Civil Service Commission approval. We do not see any reason why they have not approved it to this point. Mr. AMBRO. Talking about the Civil Service Commission, is there a I)roblem at all with respect to the Civil Service Commission and our earlier colloquy about personnel? Dr. GAGE. There are, I would say, a variety of difficulties that arise from time to time, some of which get resolved after a time and some of which appear to be almost irresolvable. I am putting aside the question now completely of manpower ceil- ings which are mandated by the President and speaking more to the functioning of the Civil Service Commission (now the Office of Per- sonnel Management). We have had one of the most nagging problems in that we have had a great deal of difficulty convincing the Civil Service Commission to establish a new functional category of toxicologist. They have been wanting to carry all of our toxicologists under the category they es- PAGENO="0126" 120 tablished many years ago of pharmacologist. Now, toxicology and pharmocology, are as defined by the Civil Service Commission, each very narrow bands of activities and the kind of toxicologist we are interested in might well have had quite a different background from these bands. He may have come out of biological research or out of any research background dealing with the way in which we assimilate drugs or chemical substances in our body. We have been wrestling with the Civil Service Commission on that and hopefully, we will prevail eventually. It would be very, very useful to us to have a new register within the Civil Service Commission so we can get up-to-date, modern tox- icologists on that new register rather than have this long list of phar- macologists who have already filled up the register, which we have to go through and screen before we can select anybody. Mr. AMBRO. Did not the old Atomic Energy Commission have an exemption or an arrangement whereby they could develop staff to meet their sophisticated needs? Dr. GAOL Certain agencies like the old AEC did get special exemp- tion. Very few other agencies have been able to get such legislation, and we had not gotten any special treatment. Mr. AMBRO. Did that come from legislation developed here and approved? Is that the way that worked? Dr. GAGE. I think that probably dates back to the Atomic Energy Act amendments of 1949 if I recall correctly I have not worked in the nuclear area for awhile and they got most of their civilian man- dates out of that set of amendments and that exemption dates to about that period. Mr. AMBRO. Have you recommended it here, and has it been turned down or what? Dr. GAGE. We have had a great deal of discussion on this particular point. We have brought this to the attention of many in 0MB. I think there is heightened concern for the shortages of toxicologists in the country. There is also admittedly a real resistance to going into any special- ist training programs since the Government seems always to overshoot the mark whenever it goes into any specialized training programs, and ends up with surpluses after a few years. I would think there are probably a handful of measures that could be taken to improve our capability to attract very good people into these areas of toxicology and epidemiology over the longer term. Mr. AMBRO. How much of the energy related health effects research is run by a different office? Dr. dAGE. Well, all of it in the sense that the planning is done under the auspices of the Office of Energy, Minerals, and Industry and the implementation is done in part by the Office of Health and Ecologi- cal Effects and in part by the other agencies that receive money from the passthrough process. Mr. AMBRO. Does that create any problems? Dr. GAGE. I will ask Steve and Bill to speak to this. I will take a crack at it first. We felt we had to have some coherency in that mission-directed pro- gram which had been assigned to us by 0MB so we established a very PAGENO="0127" 121 small staff in the then new Office of Energy, Minerals, and Industry to oversee the coordination of those activities in order to one, present a coordinated budget to the Congress and two, bring about the inte- gration of the results from those activities. We set that up so the planning would be done within one office, but the actual execution of the project would be done under the purview of the other Deputy Assistant Administrator. It was not a matter of one office meddling in the actual research conducted in the other offices. Mr. .&MBRO. Now that the author has spoken he has no pride 0± ownership. Dr. REZNEK. In the Agency, the establishment of the energy pro- gram,, particularly the health portions of it, was a first experiment in placiug the Agency in a central management role or coordination role to deal with all of the Federal programs and health research activities. At that time this was a very highly visible problem and a separate office was set aside to deal with the planning and allocation of the re- sources. This required communication and cooperation with HEW, the Department of Energy, the Department of the Interior, and sev- eral other agencies to coordinate all the energy research, to direct that research, and to try to assure the entire Federal effort was organized and well directed. In some sense this was a new experiment for the Ag~ncy and one that went off quite well. The results were quite valuable. We went through a set of audits periodically to make sure that the program that we were administer- ing did not overlap, conflict or reproduce programs in a wide variety of agencies. I think that experience we gained went quite far toward smoothing the way for implementing the cross-agency ZZB. It was a trial period. We showed it could be done and gained a reputation for being able to handle multiagency management and review. [The following question and answer were submitted for the record:] - Question. The DOE, of course, participated in the valuable experience you are talking about. They also support a considerable amount of health effects re- search. Why doesn't the DOE participate in the cross-agency ZBB on health effects research? Answer. The Office of Management and Budget conducted two interagency ZBB reviews. One examined the energy/environment research programs in DOE and EPA. This review treated both environmental processes and effects includ- ing health research, and environmental control technology. The other ZBB review was the seven agency review of health research. The energy/environment review was initiated first and was well underway when 0MB decided to undertake the cross-agency health review. Since the energy review already encompassed almost all of DOE's resources, 0MB elected not to include them in the health review. The downside is the extra t~me requirement when you participate in intera~rency arenas-you take the time to make sure people produce enough information, that you go over your information and their in- formation; all this slows you down. T}'ere were, in `fact, cases where our inability to maintain the closeness of control we would have liked resulted in investments in some research projects which were not as productive as we would want. On the whole, I think the program has been very beneficial. The benefits have come in being able to move the entire Federal area and PAGENO="0128" 122 the ability to recognize major problems that many agencies can par- ticipate in through a process that produces quite a sensible discussion of those things rather than bureaucratic fighting. Dr. MURPHY. I will not take as much time, since I have discerned no major pr~ble~ms. We are working more closely with other offices and are much more democratic in our approach to the way we do things. It does complicate our management, but we are accommodating to that and the end product is considerably better for it. Mr. AMBRO. Under whose auspices was the Union Electric pro)ect in St. Louis utilizing coal dust and solid waste for fuel? Dr. REZNEK. That program was under joint participation by us and the Office of Solid Waste. Mr. AMBRO. Is that program over? Dr. REZNEK. Yes. Mr. AMBRO. What do you do with it? Dr. REZNEK. The results of the cost and capabilities of that particu- lar demonstration juIreceiving wide interest. There is interest on the part of many rnuiiicipalities in pursuing that type of a system to reduce costs; namely, separating waste and using burnable waste as part of the fuel for an electric utility. I could do a followup and find out if there are any municipalities moving to establish such a system. I am not sure, now, if the St. Louis system is being adopted. Mr. AMBRO. Well, it gets back to where we were before. We have had certain programs that now have been completed. I suppose we `have a report, do we not, with respect to this? It now rests with the munici- pality to take the initiative to come back up here and say let me have a copy of this, or how does it work, or tell us about it, and things like that. Is that the way it works? Dr. REZNEK. Partially. In this case, there is another mechanism. The Office of Solid Waste has a $15 million appropriation to pro- vide money for planning grants for resource recovery and solid waste handling systems. They have signed interagency agreements with the Department of Energy. DOE has money to do demonstrations such as that in St. Louis. The jnformation that we generated is combined into guidance packages on the use of these planning grants. Past demonstrations are a major source of technical information. If a municipality wishes to undertake a demonstration using DOE re- sources, there are procedures for using both EPA planning and DOE hardware money. The result o~the St. Louis demonstration has been made available to the people who are using those planning grants. The result is that planning grants are not only attempting to make funds available to solve some real problems; they also provide a very effective tech- nology transfer mechanism for the results of previous demonstrations. This information has been made available to local governments. [The following question and answer were submitted for the record:] Que8tion: Will EPA spend $20 million at the National Laboratories in fiscal year 1980? What are the financial arrangements involved? Are there any sys- tematic personnel exchanges with the National Laboratories? Please give examples.' PAGENO="0129" 123 Answer: Current plans call for spending between $15 million and $16 million In the National Laboratories in fiscal year 1980. Programmatically, the antici- pated distribution of these funds is as follows: In m4flions Effects of combustion pollutants on terrestrial ecosystems $1. 3 Effects of petroleum hydrocarbons and drilling muds on marine eeosystems. 1.0 Marine/estuarine effects of cooling system biocides . 2 Effects of combustion related pollutants on freshwater ecosystems 1. 8 Transport and transformation of combustion pollutants In the atmosphere_ 2. 7 Human health effects of energy processes 8. 5 Total `15. 5 The financial arrangements are handled through interagency agreements and associated subagreements with the Department of Energy. While the 1'financial flow" is through DOE Headquarters, EPA personnel maintain a close manage- ment overview of the research being performed. This Is accomplished through formal program reviews and site visits as well as numerous informal interactions. I should point out that as part of the Interagency Energy Health and Environ- mental Effects Program, which is administered by EPA, we have similar arrange- ments with nine other Federal agencies, in addition to DOE, and anticipate spend- ing approximately $16 million In these agencies in fiscal year 1980. We have had no systematic exchange of personnel with the National Lab- oratories. We have, however, recently initiated a system whereby our research personnel can be given sabbaticals to pursue specific research activities in othei~ Institutions. Mr. AMBRO. What is the relationship `between your office and that of the National Laboratoti~s doing work in, let us say, resource recovery with respect to the utilization of certain ingredients, for example, to separate glass out and `grind it up and mix it with a polymer to get brick building blocks and sewer pipes and things like that. How is it all wov'en together so that both the private sector can take advantage of it and the pu'blic sector can as well? How does that all `work? Dr. REZNEK. Frankly, sir, there have `been a series of attempts over the last 3 years to produ'ce a formal `mechanism, a memorandum of understanding, of how, in fact, the two agencies would cooperate in this area. This memorandum of understanding has not been con- summated. Mr. AMBRO. Why? Dr. REZNEK. There are two major problems for which maybe there is an actual solution. The two major problems `have `been territoriality and DOE's lack of experience in the area. Mr. AMBRO. Territoriality? Dr. REZNEK. Yes; on whether it was our program or their program. In several cases the working level stopped communication which should have taken place. Secondly, they have been going through a birth. period w'here, in fact, `they are learning and developing some of the organizational concerns that are necessary to take over the program. Mr. AMBRO. Who is "they"? Dr. REzNEx. The DOE. Our funding for `St. Louis has gone down considerably. Our role will not `be as a major source of grants to or- ganizations wishing to demonstrate new technologies. More and more we will rely on the DOE for the resources `for dem- onstration facilities, and our role will be assessment and technology transfer. 43-778 0 - 79 - 9 PAGENO="0130" 124 ~ Part of that will be the environmental assessment ; for example, whether or not there are air pollution problems So our role in making funds available is, in fact, decreasing in importance Our role will be assessment. [The following questions and answers were submitted for the record:] In your oral statement you say that EPA is deleting the work in waste as fuel. Qae8tion. What specific projects or activities are programed for the Energy `Oontrol Technology Program under the Resource conservation and Recovery Act? Answer There will be no activities planned for the energy control technology program under fiscal year 1980 `RORA funding. Questwn What is the current role in Resource Recovery vis a vis the DOE? Answer The current EPA program in resource recovery under RORA appro~ prtlations is limited to baSic developmental efforts of marketable products from municipal wastes Preliminary assessments of industrial hazardous waste con tributions were just initiated in fiscal year 1979 therefore no major activity is planned in this sector A memorandum of understanding denoting DOE s and EPA's interests in this area is currently in preparation Oeneraily capital in tensive commercialization of recovery approaches will be undertaken by DOE. Que8tIos If EPA won t be funding demonstration facilities will EPA have any influence in what new energy Resource Recovery technologies are demon- strated? Does EPA want any influence in this area? Answer I believe that EPA can realize its interests in preventing or minimiz lug environmental impacts through judIcious interagency planning without the dependence on funding full scale demonstration projects Questwn There ~s also RORA funding in the Interdisciplinary Program What activities or projects are planned with these funds9 Answer. This effort is part of the President's continuing program to increase support for basic research The new fiscal year 1980 center will address the re search needs in integrated exposure monitoring, ultimate wastes disposal prac- tices intermedia transport and integrated watershed studies Mr. AMBRO. Well, this committee, it seems to me, has jurisdiction over a wide variety of agencies and departments with respect to re~ search and development. We ask all kinds of silly questions, as you can see, azid stick our nose into the executive branch as well It would seem to me that if these problems cannot be solved solely within the executive branch, if they have real meaning to the efficiency of a particular program, we could develop a congressional mandate There is a reluctance on the part of an agency to say to a congres sional committee, we would like you to help us with another agency in the executive branch. I suppose that is what you called territorialities. Dr. REZNEK. Sir,. one of the reasons for expressing it as bluntly as I have is I believe that these questions should be examined Mr AMBRO I thought you were singularly not very blunt You got the picture Dr REZNEK I believe that a lot of these problems are on the road to solution The degree of cooperation and the definition of the roles are becoming clearer all the time They are certainly considerably clearer now than they were, and I believe the status on these types of questions is certainly acceptable at this point In a generic sense I believe that is the role of the Congress, cer~ tamly to overview, our function and to settle the major questions of that sort. I think in this area, though, I would be glad to submit the informa- tion necessary to convince you about the relationship I think in this area the problem is well on the road to being solved, if not solved. [The following questions and answers were submitted for the record] PAGENO="0131" 125 Question. What is the current status of the transfer of energy related control technology projects proposed by OEMI in a memorandum of January 11, 1978? What projects were discontinued at EPA in FY-1979? Were these projects con- tinued by DOE? Answer. EPA's Research and Development Authorization Act specifically pro- hibits EPA from transferring energy control technology projects to the Depart- ment of Energy. No projects have been transferred, nor will any be. Because of funding reductions, EPA has had to discontinue certain energy control tech- nology activities. The major areas of curtailment have been (1) discontinuance of the chemical coal cleaning program and all support of the Meyers process test facility, (2) a very reduced testing program for the chemically active fluidized bed residual oil, lignite test unit, (3) a shortened test schedule and probably discontinuance of pressurized fluidized bed combustion mini-plant, (4) a Cur- tailed test program at the Homer City coal cleaning plant and (5) elimination of scheduled new projects in mined land reclamation techniques. The EPA projects in ph~si~cal coal cleaning and chemically active fluidized bed combus- tion will be partially supported with funds transferred from the Department .of Energy. The ` projects remain totally under EPA direction, however. Question. What is the status of the EPA/DOE Memorandum of Understand- ing concerning coordinating procedures for establishing environmental protec- tion standards fOr new energy technologies? AnsWer. Working groups within EPA and DOE are meeting regularly to com- plete the memorandum. A final draft should be completed and ready for signa- ture within a few weeks. All the major questions regarding such isSues as process initiation, guidance and standards for pilot demonstration or cominer- cial facilities, and access to facilities and review of data have been resolved. The two remaining, points are the standards or guidelines applicable to succes- sive technology modules later constructed at the site of an initial demonstration unit and the standards or guidelines applicable to technologies that are unduly delayed in their design and/or construction. No fundamental differences exist and the staffs `are now drafting acceptable language. Question. If it has been difficult to produce a Memorandum of Understanding with DOE, then what information can you submit to convince the subcommittOe that the problems of roles, territories, and cooperation are being solved? Answer. The DOE and EPA staffs have engaged in continuing conversations and exchanges to assure that the energy control technology program will be planned, reviewed and implemented in the best possible manner. More impor- * tantly, the Assistant Secretary for Energy Technology has met with EPA staff and assured continued cooperation and expedited handling of a general inter- * agency agreement for the control technology program. The Office of Fossil Energy (DOE) has stated on numerous occasions that they intend to operate in a' mode that will assure open communication and cooperation in planning and Implementing the program. Mr. AMBRO. Well, as you know, we are under a time constraint to mark up and report out these authorizing budgets by March 15. We have three of them here. We are under a more immediate time con- straint at 1 o'clock to remove ourselves' from these premises because another subcommittee is coming in for an organizing and planning meeting, so I will end this line of questioning. It may be that during the course of the year after we meet our com- mitments for the authorizing legislation, we can get into this in greater depth, and I know that you are up here all the time testifying, and I do not know when you get time to do anything else, and that is why I wanted to go as long as we could to give you a day off tomorrow. I do not know that I have really touched all of the things that might produce questions either in the full committee or on the floor later on, but we will be in close touch with written questions through staff interface and see how it goes. I see Mr. Blanchard is still here. If you want to use 3 of the 4 remaining minutes, please do so, and I will wrap it up. Mr. BLANCHARD. I would like to, if I could, Mr. (~hairman. PAGENO="0132" 126 Do you do noise research? Dr. GAGE. No; we do not, Mr. Blanchard. The noise research activi- ties in ORD had been very minimal in the first years of the Agency, and I think most of them were terminated in 1975. Mr. BLANCHARD. Where is that done now? Dr. GAGE. We. do not have a noise research program in the Agency to any significant extent. However, it is my understanding that the Office of Noise Abatement and Control [ONAC] has a small program and that the President's budget for 1980 includes a modest increase in this activity for health effects. Mr. BLANCHARD. Do you know if it is going on in some other agencies? Mr. TRAKOWSKI. It has been many years since I left the area of knowledge of the noise research. The intent of the Noise Control Act is that EPA will not duplicate efforts conducted by other agencies. Mr. BLANCHARD. That is interesting. Mr. TRAK0WSKT. At the time the decision was made to foreclose the ORD research on noise. ONAC made ample use and continues to make use of work which is done by OSHA, FAA, NASA, and DOT. EPA has taken an active role in coordinating the noise research of all FedS eral agencies. [The following question and answer were submitted for the record:] Question. Enforcement of the regulations under the Noise Control Act began in January 1978. Have there been any challenges to these regulations on the ba~is of inadequate health effects data or lack of demonstrated control tech- nologies? Do you foresee any future problems for which research may be needed? Will any of the research planning committees be given the responsibility for monitoring the area of noise research? Answer. Enforcement of EPA's noise emission regulations for newly manu- factured trucks and portable air compressors began in January 1978. The only legal challenge to these regulations after their promulgation has centered on the enforcement provisions of the promulgated regulations. There were, of course, submissions to the rulemaking docket prior to promulgation of these regulations which commented on the health and welfare analysis and the availability of technology. However, these never reached the point of serious challenge. The reason that these issues have not been an impediment to the promulga- tion of the noise regulations so far has been that these regulations represent the first serious attempt at controlling the emissions from these products. For all intents and purposes, these products were uncontrolled at the time the regulation went into effect. Consequently, it has not been difficnlt to identify technological changes which can be made to the equipment nor to justify the reduced levels on the basis of health and welfare data which i~ already available. As we return in the 1980's to look at these products a~iain with the possibility of requiring further reductions, however, we expect there will be a need for tech- nology development and further health and welfare data. Such a re-visit to these products will be necessitated in most cases by the fact that the number of these sources in the environment is growing so rapidly that unless further reductions are made beyond these initial levels, there will be little total relief offered to the American people. Needless to say, the primary justification for more research In the health and welfare area is the possibility of quantification arid documentation of very serious health effects associated with noise. Specfically, there are a number of European studies which show a strong correlation between noise and cardiovascular disease and related diseases and If in fact this relationship does exist, as we suspect it does, then it is Important to confirm this and make this information available both to the Federal rulemakers and State and local decsion-inakers. In addition, in~ dividuals have a need for this information since, in the case of noise more than other pollutants, individuals `have considerable control over their exposure. PAGENO="0133" 127 In summary, both technology demonstration and health effects research are Important components in the future national noise control effort if we are to make further advances in the reduction of exposures to the public and the avoid ance of adverse health effects. For the present, because a noise research program does not exist in ORD, none of the research planning committees has been given the responsibility for monitoring noise research. The situation will be reexamined when a noise re- search program comes into being. Mr. BLANCHARD. Thank you. Earlier you alluded to the percentages of moneys being spent, some in-house and some in procurement. What was that? What was the percentage of your research budget? Dr. GAGE. The amount planned for in-house in fiscal year 1979 is 29.3 percent of our total budget. Mr. BLANCHARD. Of your total R & D. budget? Dr. GAGE. That was $312,400,000 in fiscal year 1979, excluding pro.. rated agency support. Mr. BLANCHARD. Fine. I just wanted to know the total amount the percentages applied to. The only other thing I have is I am still not clear en the extent to which you actually test the chemicals under your health effects re- search. / [The following question and answer was submitted for the record:] Question. It would be helpful to know the approximate dollar amounts in the Health Effects Research program that fit into categories such as the following: I. Short-term tests and screening techniques: A. Development of short-term tests/techtiiques. B. Validation of existing tests/techniques. C. Conducting tests and screening techniques. II. Long-term tests: A. Conducting long-term bioassays in laboratory animals B. Improved methodology III. Epidemiology: A. Improved methodology B. Conducting studies IV. Clinical studies: A. Developing methodology B. Conducting studies V. Testing for exposure or accumulation: Can you supply the approximate amounts by these or similar categories? Answer. As part of the cross-agency toxics research ZBB exercise conducted by the Office of Management and Budget to develop the 1980 President's Budget% EPA partitioned its health effects research (excluding non-Ionizing radiation, but Including all other media) into subcategories which although not Identical to those identified in this question, are somewhat similar. We have provided that existing Information below; if resource estimates for the categories Identi- fied in this question are required we can supply them shortly. (Dollars in millions] F~8oai year 1980 Cross-agency categories budget requeat Mechanisms and actions 2.9 Short term (screening) tests 24. 3 Submammalian tests 2. 6 Mammalian tests 21. 0 Lab assessments 4.0 Extrapolation of submammalian and mammalian test results . 9 Clinical studies ~ 3 Epidemiology studies 20. 8 Exposure 8.5 (Nonlonizing research would increase the following categories:) Mammalian tests +1.5 Epidemiology +. `~ Mechanisms and action +1.0 PAGENO="0134" 128 How much do you do yourself and how much is farmed out to in- dustry or universities, and how does that really work; and as I said, if I were to come to you and said I am a person with a scientific back- ground and someone has told me something is poisonous, can you test it, just how does that get done? Dr. GAa]~. Let me clarify. The Toxic Substances Control Act put the burden of responsibility on U.S. industry for testing the chemicals that they are developing and wish to introduce into commerce. What EPA has the responsibility of doing is putting out the rules and guidelines for the actual conduct of those tests by industry. We receive, then, the results of those tests. That takes care of new tests, all new chemicals coming onto the market. Mr. BLANCHARD. You receive the results? Dr. GAGE. We receive the results. Mr. BLANCHARD. Obviously, you review them. Dr. GAGE. We review them and if it looks like they are hazardous, we may have the industry do the longer term animal studies. Mr. BLANCHARD. Do you have some resources of your own you can use for testing? If you receive samples, can you do your own testing? Dr. GAGE. That leaves roughly 70,000 chemicals which are in com- merce today which we have discovered through the inventories that are being published. Those 70,000 represent the problems of the past and the present, if you wifl, and those are the ones we are having to deal with. It was a lot more burdensome task than we realized about a year ago before the inventory was put together.. We have capability of probably testing a few thousand of those 70,000 at best and that would be only in qualitative sense. Mr. BLANCITARD. A few thousand a year? Dr. GAGE. A few thousand of the 70,000. Mr. BLANCHARD. Are you talking about a few thousand a year or forever? Dr. GAGE. Of the total universe of 70,000 we might be able to test several thousand of those. Several hundred we can test very well and we have a standardized test procedure for those. Mr. BLANCHARD. One final question and I know I am stretching it. Do you publish? Do you have a source, an office or a person in your shop who collects published studies on the testing going on of all sorts, and where I could get these studies or a scientist in Michigan could get them to see what has been done? Is there some central focal point of publication so that the universe of data that you are dealing with could be available to your own people, to us, or someone else? Dr; GAGE. They are just in the process of setting up this new effort within our Office of Toxic Substances but they will have a group on chemical information under the Deputy Assistant Administrator Marilyn Bracken. They will have the most extensive data base on what tests have been performed on what chemicals. Individual inquires through the regions can help on the more com- mon chemicals and the more exotic ones. Mr. BLANCIXARD. Thank you. PAGENO="0135" 129 Mr. AMBRO. One final point. You have some unique research facili- ties. The public interest might be served by time-shared operations. Does EPA have the ability to be reimbursed by outsiders for ex- penses incurred in sharing facilities and if you do not, would it be help- ful to have that authority? Dr. GAGE. We do not have that authority at this point, Mr. Ambro. We have raised questions about that authority in the past, particularly in connection with our oil spill testing facility up in New Jersey. I can see the question broadening a great deal more now with our highly unusual clinical test facility for human inhalation down in North Carolina and our unique engineering test and evaluation facility in Cincinnati we are bringing on line. The question is how. Mr. AMBRO. Well, I do not know exactly where or how we can pro- vide that authority. Maybe we can talk about it. Indeed, we will be in touch during this intensive work period. I would like to thank you, Dr. Gage, and everyone who came with you and those on this panel and indeed, everyone who sat through it for spending so much time with us and we will stand adjourned until ~ p.m. on Thursday. [The following additional questions and answers were submitted for the record:] Question. Under the Clean Air Act, EPA has certain responsibilities to set ionizing radioactivity standards. Exactly what is EPA's, authority? Does EPA do research in this area? Why or why not? If not, who does EPA rely on to conduct the research necessary to set these standards? Answer. The Clean Air Act Amendments of 1977 authorize EPA to regulate radioactive air pollutants through the standard setting authorities of that Act, including National ~Amblent Air Quality Standards, New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants. These authorities relate to situations in which the public health is or may be endan- gered. The Uranium Mill Tailings Radiation Control Act of 1978 provides author- ity for the comprehensive coverage of mill tailings at active and inactive uranium mills, and requires a report and recommendations on any necessary steps to elimi- nate hazards at uranium mills. These legislative authorities set out a standard setting, environmental assess- ment, and technology assessment role for EPA. Research and Development re- sponsibilities related to ionizing radiation are set out for other agencies, notably the Nuclear Regulatory Commission, Department of Energy. EPA does not allocate funds for research on ionizing radiation, but rather focuses its attention on the effects of exposure to nonionizing, or electromagnetic, radiation. Question. What are the indications that ambient levels of nonionizing, micro- wave radiation will have health effects? What projects have been initiated with the Congressional add-on for fiscal year 1979? This seems to be an area likely to yield rather fundamental research, i.e., research on the mechanism of the effect done at the cellular level. Answer. Although available information indicates that adverse health effects from current ambient levels of nonlonizing radiation (NIR) are unlikely, the levels of NIR in the environment have been increasing significantly each year. On the average, 99 percent of the general population is thought to be exposed to ambient levels below one microwatt per square centimeter at this time. This is lower than levels reported by Johns Hopkins University in a study of the U.S. Embassy in Moscow, where no adverse health effects were found. In addition, a study conducted by the U.S. Navy showed no significant differences in cause of death or life span between twenty thousand radar workers and a matched population not exposed. 11 must be remembered, however, that while these two studies yield Important information, they must be corroborated in order to ensure that exposure guidance for the general population Is adequately protective. Our research will help deter- PAGENO="0136" 130 mine whether regulations are necessary to curb increases in environmental ex- posures, and If so, our program will help provide a basis for establishing permi~si- ble exposure levels. The kind of information needed for this task includes that on parameters more subtle than mortality data. Further, it is true that the mechanisms of interaction between nonionizing radiation and biological tissue are not well understood. Obtaining such information will, over the long term, con- tribute to determining whether future revisions of exposure guidance will be necessary. The fiscal year 1979 CongressIonal add-on is being devoted In part to studies of interactive mechanisms, where low Intensity exposures are being used. The funds are also being devoted to determining, in animals, whether infant mortality may be associated with prenoted microwave exposures, to investigating delayed effects in humans, and to studying the effects of low-level exposures on immune responses. In addition, the add-on is being used to compare effects from pulsed vs. continuous exposures to determine whether exposure guidance should incor- porate provisions for exposure mode. Question. The Subcommittee has an overall interest in seeing that there is adequate support for R.D. & D. in control technology and in understanding what role EPA can and does play. There is concern that if EPA does not support con- trol technology R.D. & D. then no one else will. To what extent do universities and the private sector support control technology research? Do either of these sources support the demonstration phase? What about other Federal agencies? It is recognized that EPA can play several different roles and this raises the follow- ing questions. Does the responsibility for the development of control techniques belong with EPA or should EPA merely get performance standards and let in- dustry meet them? Should EPA's role focus on using basic research to generate new ideas? Or should the EPA role be one of promoting technology transfer or quality assurance? Answer. EPA's major role in control technology is to support the development of new innovative processes and to promote new technology utilization through a system of research grants and contracts. The following paragraphs exemplify this In two major R.D. & D. areas: (a) municipal control technology in support of the construction grants program; and (b) Industrial control technology in support of the Effluent Guidelines and New Source Performance Standards programs. For the municipal sector, performance standards have been set for Publicly owned Treatment Works (POTW) in the form of the requirements for secondary treatment. Experience has shown that the incentives for development of improved wastewater pollution control equipment have not been great enough to stimulate a viable private sector research program. Since the municipal construction grants program Is federally funded, it Is in EPA's interest to have ORD assist the municipalities by developing cost-effective control technologies In order to insure that the construction grants program Is a totally Integrated and planned pro- gram. We do this in two ways. First, our research efforts generate new Ideas by supporting basic research as well as pilot plant demonstrations, and, in some cases, full scale demonstration projects. Second, once an Idea has been proven through demonstration projects, we make the additional effort of promoting it among municipalities and engineers who are continuously Involved in designing and building new POTW's. Over the past six years, we have tried to emphasize supporting bench and pilot scale projects while leaving the large scale demonstrations to Industry and local governments. Universities and other Federal agencies have mostly limited their efforts In this control area to R.D. & D. projects which are either solely funded through EPA grants and contracts or are jointly funded. In the industrial control technology area two types of firms have an Incen- tive for Investing In pollution control RD&D. Manufacturing firms often support some control technology development in order to reduce the cost of complying with environmental regulations. Firms which sell pollution control equipment also Invest in developing new or improved technologies. The most important source of private research support Is directed toward product development, e.g.. water treatment chemicals, carbon absorption, flue gas desulfurization, lead free gasoline and catalytic converters. For the most part, the research Is applied engineering and Is supported by vendors rather than polluting Industries. The incentive for firms to develop truly new control technology when the market for that technology has to be created by rerulatory action is small. The uncertainty of regulatory requirement has meant that with a few exceptions, firms have not PAGENO="0137" 131 invested In control technology R&D unless the performance of the concept was fairly well established. Industrial associations also play a small role in pollution control research and development. The largest Industrial organization R&D program is that of the Electric Power Research Institute. The National Coal Association and the Amen- can* Iron and Steel Institute, for example, have small programs. Other Federal agencies coiktnibute to the support of pollution control RD&D. There is a sub- stantiàl program in the Department of Energy, while the Department of the Interior has small programs in the Bureau of Mines, the Office of Surface Mining and the Office of Water Research and Technology. EPA must have several roles In the industrial pollution control research and development area. In cases such as control of combustion emissions of nitrogen oxides and flue gas desulfunizatlon, EPA has Identified promising concepts, proved their feasibility in the laboratory and demonstrated the technology at both pilot and commercial sizes. In other cases, for example, particulate control, the EPA program has focused on evaluating existing facilities and technologies and has analyzed the available data. The results of these studies has been a systematic alternative for calculating the costs and performance of alternative technologies and designs. Another important function Is information evaluation and dissemination, parS ticularly for technology users, such as small towns or small firms. Federal re~ search and development programs are the most, If not the unique, source of technical Information on industrial pollution control and waste management. It Is difficult to draw firm conclusions which will not contain contradictions. However the Incentive for private interests to undertake RD&D is small and the structure of many polluting and control equipment supply firms or organiza- tions does not allow them to accumulate the capital needed for research Invest- ments. Question. What is the primary mission of the EPA Large Lake Research Laboratory In Grosse lie, Michigan? Answer. The Large Lakes Research Station in Grosse lie, Michigan is re- sponsible for characterizing the pollution problems of the Great Lakes, deter- mining the dynamic processes affecting pollution of large lakes, and developing predictive models for describing the fate and effects of pollutants In the Great Lakes. The Great Lakes Program addresses the following specific areas: Euthrophlcatlon (or nutrient enrichment) and its effects. Problems associated with power reduction (such as entrainment of planktonlc organisms and larval fish in once-through cooling systems.) Disposal of dredging spoil, and the ecological effects on wetlands of shoreline construction and hydrologic modifications. The source, fate and effects of toxic substances associated with Great Lakes water, sediments and blota; and the environmental exposure of toxic substances to humans. Question. What primary programs and activities would be curtailed as a result of EPA's proposed $2 million cut In this facility's fiscal year 1980 budget? Answer. The $2 million reduction In Great Lakes program is `the result of two actions: a $1.5M Congressional add-on in fiscal year 1979 that was not carried forward to 1980 and $525,000 reduction in the base program. The reduction In the base program Is possible because It has progressed to the model simulation stage whereby fewer EPA funds are necessary to accomplish Intended program objectives. The $1.5 million reduction will reduce work on: Establishment of a human effects testing program t~ identify toxic organic substances and their impact upon the aquatic ecosystem and upon humans as a result of environmental exposure. Eutrophication verification a's well as Uladophora control demonstration pro- grams which are intended to form the basis for future Great Lakes hazardous substances models. Question. What are some of the immediate practical effects of the research being conducted at this facility that would not be realized as a result of this budget cut? Answer. As Indicated earlier, we will proceed on a limited basis to verify and update eutrophication models developed to date. Some specific studies such as those on selected hazardous substances for the Great Lakes will not be under- taken. However, ongoing studies of hazardous substances which will be continued include those to establish pathways and reservoirs, estimates of the persistence of PAGENO="0138" 132 hazardous substances, and modeling of such substances in Great Lakes food chains. Que8tian. If the laboratory's budget Is cut, who will be responsible for continu- ing research In the areas of eutrophication; hazardous materials; and the funda. mental processes of pollutant transfer, accumulation, and fate and effects as they relate to the Great Lakes? What are some of the problems inherent In having the States assume these research activities in terms of data consistency and quality control? Answer. The Large Lakes Research Station would still be responsible for con- ducting research in these areas, but It will be at a reduced level. In addition, Individual States and the Canadian Confederation would continue research in these areas. Question. What is the rationale for scaling down EPA's Involvement in Great Lakes research? Answer. The internal EPA ZBB budget ranking procedure for fiscal year 1980 recommended that the EPA fund the Great Lakes Research Program below the fiscal year 1979 resource base level. The rationale for this decision was that the eutrophication thodeling program had achieved major objectives and there were more pressing operational program and regional needs with higher priorities. Question. What percentage of the total Great Lakes research effort conducted by the Federal Government takes place at the Grosse Ile facility? Answer. We estimate that the Large Lake Research Station funds about 40 percent of the total Great Lakes research effort conducted by the Federal Gov- ernment in fiscal year 1979. This takes Into consideration research performed by Fish and Wildlife, National Oceanic and Atmospheric Administration and the Corps of Engineers. It does not include other Great Lakes activities which are classified as field monitoring and surveillance such as that performed by EPA's Region V offices. Question. Has the EPA performed a risk assessment for the proposed regula- tions for organic substances In drinking water? If not, does the EPA plan to? How can the EPA proceed with these regulations without sound risk assessment techniques? How does the EPA justify a decrease of $2.6 million In the Inter- disciplinary Scientific Assessment Program at a time when the need for care- fully weighing risks, benefits, and costs Is being emphasized? Answer. The EPA Office of Drinking Water has referenced several risk esti- mations In the development of Its proposed regulations for trihalomethanes. The assessments were done by the Science Advisory Board-EPA, the Carcinogen Assessment Group-EPA and the National Academy of Sciences. The discussion of risk can be found in "Statement of Basis and Purpose of an Amendment to the National Interim Primary Drinking Water Regulations on Trihalomethanes, ~anuary 1978." The Scientific Assessment Program has as one of Its objectives the develop- ment and improvement of risk assessment teshniques. The $2.6 million reduction for fiscal year 1980 does not Impact this activity but rather reflects the comple- tion of a one-year program to develop water quality criteria for the 65 Consent Decree Pollutants. [Whereupon, at 1 :10 p.m., the subcommittee recessed, to reconvene at 2 p.m., on Thursday, February 15, 1979.] PAGENO="0139" 1980 AUTHORIZATION FOR THE OFFICE OF RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY THtIRSDAY, PEBRUARY 15, 1979 U.S. HOUSE o~ REPRESENTATIVES, COMMITTEE ON SCIENCE AND TECHNOLOGY, SUBCOMMITTEE ON NATURAL RESOURCES AND ENVIRONMENT, Washington D.C. The subcommittee met, pursuant to call, at 2 p.m., in room 2253, Rayburr~/ House. Office Building, Hon. Jerome A. Ambro (chairman) presiding. Present: Representatives Ambro, Watkins, Lundine, and Walker. Mr. AMBRO. If we can get started I would like to do so because we have a time limitation on the use of this room. I would like to welcome each of you today. Today, the Subcommittee on Natural Resources and Environment continues its oversight of the Environmental Protection Agency and its review of their fiscal year 1980 budget request by hearing testimony from five public witnesses. We call these public witnesses not because we expect them to pro- vide us with analysis of EPA's budget but rather because each of them has particular experience `which we believe will provide very useful context to us as we proceed with our authorization of EPA's research and development programs. Dr. James Pitts, Director of the Statewide Air Pollution Research Center at the University of California, Riverside, is a distinguished scientist with many publications dealing with photochemical smog. We will honor Dr. Pitts, who needs to catch an early flight to Cali- fornia by having him as our first witness. Dr. Pitts will discuss EPA's recent revision of the National Ambient Air Quality Standard for Photochemical Oxidants. There is some question as to whether or not this revision is supported by adequate scientific information and we therefore have an interest as this deals with the output and utilization of research results. Dr. Pitts, we welcome you and thank you for coming all this way and ask you to, in your own way, proceed. STATEMENT OF DR. IAMES PITTS, DIRECTOR, STATEWIDE AIR POLLUTION RESEARCH CENTER, UNIVERSITY OF CALIFORNIA, RIVERSIDE, CALIF. Dr. Pirrs. Thank you, sir. It is a ~privilege to be here and I am happy to respond to the invitation from this subcommittee. (133) PAGENO="0140" 134 My entire printed testimony has been submitted for the record so in my verbal testimony, in the interest of time, I shall simply sum- marize the major points, if that is acceptable with you. Mr. AMBRO. That is fine. Without objection, we will make your en- tire written testimony a part of the record at this point. [The full prepared statement of Dr. Pitts follows:] PAGENO="0141" * 135 TESTIMONY TO THE SUBCOMMITTEE ON NATURAL RESOURCES AND THE ENVIRONMENT OF THE COMMITTEE ON SCIENCE AND TECHNOLOGY OF THE U. S. HOUSE OF REPRESENTATIVES JAMES N. PITTS, JR., Ph.D., DIRECTOR STATEWIDE AIR POLLUTION RESEARCH CENTER UNIVERSITY OF CALIFORNIA, RIVERSIDE FEBRUARY 15, 1979 INTRODUCTION IT IS A PRIVILEGE TO RESPOND TO YOUR INVITATION TO DISCUSS THE RECENT CHANGE IN THE AIR QUALITY STANDARD FOR PHOTOCHEMICAL OXIDANT AS WELL AS SEVERAL GENERAL ASPECTS OF PAST, CURRENT AND PROJECTED EPA RESEARCH BUDGETS AND PROGRAMS, ESPECIALLY WITH RESPECT tO THEIR APPLICABILITY TO THE REGULA- TORY FUNCTIONS OF THE EPA. MAY I POINT OUT AT THE OUTSET THAT MY VIEWS ARE NOT NECESSARILY THOSE OF THE UNIVERSITY OF CALIFORNIA. ADDITIONALLY, I SHOULD NOTE THAT MY RESEARCH pROGRAMS IN PHOTOCHEMISTRY AND AIR POLLUTION, CONDUCTED OVER THE LAST TWENTY- FIVE YEARS Al' UC RIVERSIDE, ARE CURRENTLY SUPPORTED NOT ONLY BY THE UNIVER'- SITY BUT ALSO THROUGH EXTRAMURAL GRANTS AND CONTRACTS FROM THE EPA, THE NATIONAL SCIENCE FOUNDATION (THROUGH ITS BASIC AND ITS APPLIED SCIENCE AND RESEARCH APPLICATIONS (ASRA) PROGRAMS), THE CALIFORNIA AIR RESOURCES BOARD, THE AIR FORCE, AND THE MANUFACTURING CHEMISTS ASSOCIATION. I HOPE MY COMMENTS ON THE R&D PROGRAMS OF THE EPA WILL BE TAXEN IN THE POSITIVE CONTEXT IN WHICH THEY ARE OFFERED, THAT IS CONSTRUCTIVE EVALUA- TION OF A MAJOR AGENCY WHICH HAS ENORMOUS RESPONSIBILITIES, MANY OF THEM SHORT-TERM AND "FIRE FIGHTING" IN NATURE, AND INVOLVING DIFFICULT CONFLICTS BETWEEN ENVIRONMENTAL, ECONOMIC AND ENERGY INTERESTS. ON BALANCE THE EPA HAS PLAYED A CRUCIAL ROLE IN PROTECTING OUR NATION#S ENVIRONMENT. PAGENO="0142" 136 MY TESTIMONY WILL DEAL WITH TWO SEPARATE BUT RELATED AREAS. FIRST, I SHALL DISCUSS THE CHANGE IN THE OXIDANT STANDARD AND CITE CERTAIN PROBLEMS ASSOCIATED WITH THIS DECISION. SECOND, I WILL POINT OUT WHAT I CONSIDER TO BE SERIOUS DEFICIENCIES IN SEVERAL PAST AND PRESENT EPA RESEARCH PROGRAMS. HOST OF THESE HINGE ON THE LACK OF EFFECTIVE LONG-RANGE RESEARCH EFFORTS DEVOTED TO OBTAINING DATA ESSENTIAL FOR DEVELOPING AIR QUALITY CRITERIA AND BASED ON THESE, FOR ESTABLISHING AIR QUALITY STANDARDS. IT IS AXIOMATIC THAT DEFICIENCIES AND INACCURACIES IN THIS DATA BASE ARE DIRECTLY REFLECTED IN THE RELIABILITY OF AIR QUALITY STANDARDS * THESE IN TURN HAVE PROFOUND IMPLICATIONS. OVERKILL IN CONTROLLING AIR POLLUTION IS UNACCEPTABLE, BUT FAILURE TO ADEQUATELY PROTECT THE PUBLIC HEALTH WOULD BE TRAGIC. FROM THIS PERSPECTIVE LET US FIRST CONSIDER THE OXIDANT STANDARD CON- TROVERSY. THE PROBLEM OF THE AIR QUALITY STANDARD FOR OXIDANT/OZONE FOR THE PAST TWO YEARS A NUMBER OF RESEARCHERS INVOLVED IN VARIOUS ASPECTS OF AIR POLLUTION --- FROM HEALTH EFFECTS TO ATMOSPHERIC CHEMISTRY HAVE BEEN DEEPLY CONCERNED OVER THE POSSIBILITY THAT THE EPA MIGHT SIGNIFI- CANTLY RELAX THE NATIONAL AIR QUALITY STANDARD FOR OXIDANT. THIS WAS ORIGIN- ALLY PROMULAGATED IN 1971 TO PROTECT THE PUBLIC FROM THE HEALTH EFFECTS OF PHOTOCHEMICAL SMOG. THESE CONCERNS WERE STIMULATED BY TWO CHANGES DISCUSSED WITHIN THE EPA AND ITS ADVISORY COMMITTEES, AS WELL AS IN THE SCIENTIFIC COMMUNITY AT LARGE: FIRST, TO REGULATE THE SPECIFIC COMPOUND OZONE, RATHER THAN THE COLLECTION OF SPECIES GENERICALLY TERMED PHOTOCHEMICAL OXIDANT AS IN THE PAST: SECOND, TO RAISE THE EXISTING PRIMARY STANDARD WHICH, AS YOU ENOW, IS BASED ON HEALTH EFFECTS. ON JUNE 22, 1978, EPA PROPOSED TO IMPLEMENT BOTH OF THESE CHANGES, RAISING TEE STANDARD TO 0.10 PPM OZONE. PAGENO="0143" 137 THUS, ON AUGUST 24, 1978, DR. ARTHUR WINER AND I, IN OUR CAPACITIES AS ATMOSPHERIC CHEMISTS, TESTIFIED AT AN EPA HEARING IN LOS ANGELES ON THE PROPOSED CHANGES. WE POINTED OUT THAT OUR PRIME CONCERN WAS NOT THE PROPOSED SHIFT FROM 0.08 PPM TO 0 * 10 PPM --- ALTHOUGH WE STRENUOUSLY OPPOSED ANY VALUE HIGHER THAN 0.10 PPM -~ BUT RATHER THE CRITICAL SUBSTANTIVE CHANGE FROM PHOTOCHEMICAL OXIDANT TO OZONE. WE STATED: * THE HEALTH IMPACT OF PHOTOCHEMICAL AIR POLLUTION RESULTS NOT JUST FROM OZONE BUT FROM THE ENTIRE SPECTRUM OF GAS PHASE AND PARTICULATE POLLUTANTS WHICH COEXIST WITH IT IN AMBIENT SMOG * THUS, ALTHOUGH SOME LABORATORY INVESTIGATIONS INVOLVING HUMAN EXPOSURES HAVE APPARENTLY NOT DEMONSTRATED "SIGNIFICANT" EFFECTS AT LEVELS BELOW ABOUT 0 * 25 PPM, WE UNDERSTAND THAT CERTAIN OF THESE STUDIES WERE CARRIED OUT WITH HEALTHY SUBJECTS BREATHING OZONE-AIR MIXTURES --- NOT WITH "PULMONARY RISK" SUBJECTS BREATHING REAL PHOTOCHEMICAL SMOG OR A SURROGATE FOR SMOG. WE THEN POINTED OUT: * TODAY THERE IS UNAMBIGUOUS SPECTROSCOPIC EVIDENCE FOR THE PRESENCE IN AMBIENT PHOTOCHEMICAL SMOG OF A HOST OF POTEN- TIALLY HARMFUL COMPOUNDS -- INCLUDING SPECIES SUCH AS FORMALDEHYDE, NITRIC ACID AND FORMIC ACID. IN ADDITION, A NUMBER OF OTHER POTENTIALLY TOXIC SPECIES ARE BELIEVED TO BE PRESENT. IN SUPPORT OF THIS STATEMENT WE ATTACHED TO OUR TESTIMONY PLOTS OF MEASUREMENTS MADE AT OUR LABORATORY IN SOUTHERN CALIFORNIA DURING A TYPICAL SMOG EPISODE IN THE FALL OF 1977. A FOURIER TRANSFORM INFRARED (FT-IR) SPECTROMETER WITH AN OPTICAL PATH OF ABOUT ONE KILOMETER, ON LOAN FROM PAGENO="0144" 138 DR HANST OF THE EPA, WAS EMPLOYED -- AND THE EPA SUPPORTED OUR RESEARCH. OUR SPECTRA SHOWED NOT ONLY THE CRITERIA POLLUTANTS --- CARBON MONOXIDE, NITROGEN DIOXIDE AND OZONE -- BUT ALSO SIGNIFICANT AMOUNTS OF NITRIC ACID, FORMAL- DEHYDE, FORMIC ACID AND THE COMPOUND PEROXYACETYL NITRATE (PAN). SEVERAL OF THESE ARE STRONG LACHRYMATORS, HARMFUL TO VEGETATION AND P~ROBABLY TO NAN. THESE STUDIES WERE EXPANDED IN 1978. THUS ATTACHED TO THIS STATEMENT ARE NEW FT.-IR SPECTROSCOPIC MEASUREMENTS OF THESE POLLUTANTS MEASURED CON- CURRENTLY WITH OZONE, WHICH DR. TUAZON MADE AT CLAREMONT, CALIFORNIA, ON OCTOBER 12, AND 13, 1978. THE POLLUTANT LEVELS WERE SIGNIFICANTLY HIGHER THAN THOSE EXPERIENCED THE PREVIOUS YEAR. INDEED, ONE CAN SEE FROM THESE PLOTS THAT ON THIS PARTICULAR OCCASION THE AGGREGATE OF THESE REAL, OR POTENTIALLY TOXIC SPECIES ACTUALLY APPROACHED THE LEVELS OF THE OZONE ITSELF. FOR EXAMPLE, ON THE AFTERNOON OF THE 13TH WHEN THE OZONE LEVEL WAS 0.12 PPM, THE SUN OF FORMALDEHYDE, FORMIC ACID, NITRIC ACID AND PAN WAS 0 * 11 PPM! IN OUR TESTIMONY WE FURTHER POINTED OUT: e ALTHOUGH THE PRESENCE OF THESE COMPOUNDS IN AMBIENT SMOG IS NOW FIRMLY ESTABLISHED, LITTLE CAN BE SAID CON- CERNING THEIR INDIVIDUAL HEALTH EFFECTS -- MUCH LESS ABOUT POSSIBLE SYNERGISTIC EFFECTS WHICH MAY OCCUR IN THIS COMPLEX MIXTURE OF OXYGENATED AND NITROGENOUS POLLUTANTS. HOWEVER, WE SHOULD ALL RECOGNIZE THAT RAISING THE OZONE/OXIDANT STANDARD FROM 0.08 to 0.10 PPM IS TANTAMOUNT TO A DE FACTO INCREASE IN THE ALLOWABLE LEVELS OF THESE POTENTIALLY HARMFUL POLLUTANTS." IN SHORT WE BELIEVE THAT THE AIR QUALITY STANDARD SHOULD BE BASED ON THE HEALTH IMPACT OF ACTUAL PHOTOCHEMICAL SMOG ON A WIDE SPECTRUM OF THE PUBLIC --- INCLUDING THE VERY YOUNG AND OLD, ASTHMATICS AND THOSE AFFLICTED PAGENO="0145" 139 WITH EMPHYSEMA. OUR FEAR WAS THEN, AND CONTINUES TO BE, THAT IN CHANGING FROM OXIDANT TO OZONE FAR TOO MUCH EMPHASIS WOULD BE PLACED ON STUDIES OF HEALTHY SUBJECTS BREATHING ARTIFICIAL MIXTURES OF OZONE AND AIR WHICH HAD ALREADY BEEN SHOWN IN SOME STUDIES TO HAVE LITTLE OR NO HEALTH EFFECT AT LEVELS BELOW 0 * 25 PPM. INDEED, WE PREDICTED THAT IF THE CHANGE TO OZONE WERE PROMULGATED THE DOOR WOULD BE OPEN FO1~ INDUSTRY AND ITS CONSULTANTS TO DEMAND A FAR MORE RELAXED STANDARD THAN 0 * 10 OR EVEN 0 * 12 PPM. THUS, WE STRONGLY URGED THAT WHILE THE STANDARD MIGHT BE RELAXED SOMEWHAT TO 0 * 10 PPM, IT SHOULD BE WRITTEN AS "PHOTOCHEMICAL OXIDANT MEASURED AS OZONE." FINALLY, WHILE A MEMBER OF THE EPA' S SUBCOMMITTEE ON SCIENTIFIC CRITERIA FOR PHOTOCHEMICAL OXIDANTS, I POINTED OUT, IN FEBRUARY 1978, ANOTHER PROBLEM INHERENT IN THE PROPOSED CHANGE FROM OXIDANT TO OZONE, WHICH IS AS FOLLOWS: TO SET AN AIR QUALITY STANDARD FOR A GIVEN POLLUTANT, ONE REQUIRES, AMONG OTHER DATA, DETAILED AIR QUALITY MEASUREMENTS FOR ~tHAT POLLUTANT AT VARIOUS LOCATIONS AND TIMES. HOWEVER, IN THE ABSENCE OF AN AIR QUALITY STANDARD FOR A POLLUTANT, THE EPA IS GENERALLY NOT REQUIRED TO EXPEND A SIGNIFICANT EFFORT TO MEASURE ITS ATMOSPHERIC LEVELS AND HEALTH EFFECTS * IN OTHER WORDS, IF A POLLUTANT IS NOT REGULATED, YOU ARE NOT REQUIRED TO MEASURE IT --- BUT UNTIL YOU'VE MEASURED IT, IT CAN'T BE REGULATED! A CONCURRENT VIEW HAS RECENTLY BEEN EXPRESSED BY AN INTERNATIONALLY RECOGNIZED RESEARCHER IN HEALTH EFFECTS. THUS, IN A LETTER TO CONGRESSMAN GEORGE E. BROWN, JR., DR. RODNEY R. BEARD, PROFESSOR EMERITUS OF PREVENTIVE MEDICINE, STANFORD UNIVERSITY, STATED: * IF OZONE IS ACCEPTED AS THE STANDARD, THE IMPETUS TO IDENTIFY THE OTHER "OXIDANTS" AND TO STUDY THEIR EFFECTS WILL BE LOST. IF OZONE BECOMES THE STANDARD, IT WILL BE MORE DIFFICULT TO OBTAIN SUPPORT FOR STUDIES ON THE OTHER 43.778 0 . 79 . 10 PAGENO="0146" 140 AGENTS, SINCE THEY WILL NOT BE SUBJECT TO REGULATION. DR. BEARD WENT ON TO STATE: o "IT HAS BEEN SAID, AND I BELIEVE IT TO BE TRUE, THAT INDUSTRY REPRESENTATIVES ARE ARGUING STRONGLY FOR THE ADOPTION OF THE OZONE STANDARD, AND THAT THEY ARE ALREADY ATTACKING THE VALIDITY OF THE STANDARD TENTA-. TIVELY PROPOSED BY THE AGENCY." IN VIEW OF THESE CONSIDERATIONS IT IS CLEAR WHY ~WE WERE DEEPLY DISTRESSED AT MR. COSTLE' S ANNOUNCEMENT ON JANUARY 26, 1979, THAT THE NEW AIR QUALITY STANDARD WILL BE 0.12 PPM OF OZONE. AS WE PREDICTED, SHORTLY AFTER HIS ANNOUNCE-. MENT, SEVERAL CONSULTANTS FOR INDUSTRY WERE QUOTED AS SAYING THAT EVEN 0 * 12 PPM OF OZONE WAS TOO STRICT AND THAT IN FACT THE AIR QUALITY STANDARD SHOULD BE 0.25 PPM (LOS ANGELES TINES, JANUARY 29, 1979). THIS ATTITUDE SEEMS REMARKABLE WHEN IN CALIFORNIA A FIRST STAGE SMOG IS CALLED WHEN OXIDANT LEVELS (MEASURED AS OZONE) REACH 0.20 PPM AND SCHOOL CHILDREN ARE PROHIBITED FROM PARTICIPATING OUTDOORS IN PHYSICAL EDUCATION CLASSES. THIS ~ LEVEL IS BASED ON THE MISERABLE EXPERIENCES OF HEALTHY PEOPLE EXERCISING IN REAL SMOG NOT TO MENTION ASTHMATIC CHILDREN, THOSE WITH EMPHYSEMA, ETC. IT IS NOT BASED ON PEOPLE BREATHING OZONE IN AIR IN ARTIFICIAL CHAMBERS! IN SUEMARY, WE SINCERELY HOPE THAT DURING THE ENSUING MONTHS MR. COSTLE WILL REEXAMINE THIS ISSUE AND REVISE THE AIR QUALITY STANDARD BACK TO "PHOTO- CHEMICAL OXIDANT MEASURED AS OZONE". ROLE OF THE EPA IN FUNDAMENTAL AND APPLIED RESEARCH RELEVANT TO AIR POLLUTION IN LIGHT OF THE ABOVE DISCUSSION, AND GIVEN THE PRESENT GOVERNMENTAL STRUCTURE AND DIVISION OF RESEARCH RESPONSIBILITIES AMONG ITS AGENCIES, LET ME NOW RAISE SOME PROBLEM AREAS THAT SHOULD BE CONSIDERED IN THE DISCUSSIONS OF THIS SUBCOMMITTEE WITH REPRESENTATIVES OF THE EPA. PAGENO="0147" 141 (1) THE MAJOR PROBLEM IN DEVELOPING, ASSESSING AND PROMULGATING AIR QUALITY STANDARDS FOR AIR POLLUTANTS HAS BEEN AND, AS IS CLEAR FROM THE OXIDANT DISCUSSION ABOVE, CONTINUES TO BE THE LACK OF A RELIABLE DATA BASE CONCERNING THE HEALTH EFFECTS OF THESE POLLUTANTS. AN EXAMPLE OF THE PROBLEMS IN THIS AREA IS THE ILL-'FATED CHESS (COMMUNITY HEALTH AND ENVIRON- MENTAL SURVEILLANCE SYSTEM) PROGRAM FOR SULFUR OXIDES, WHICH WAS TEE SUBJECT OF A DETAILED REPORT BY THIS SUBCOMMITTEE IN NOVEMBER 1976. WHILE MANY COGENT RECOMMENDATIONS WERE MADE IN THIS REPORT, IT IS NOT ALTOGETHER CLEAR AS TO WHETHER THESE HAVE BEEN IMPLEMENTED IN ON-GOING RESEARCH PROGRAMS, NOT ONLY FOR SOx BUT FOR OTHER POLLUTANTS * THUS, IN A PARALLEL AND EXTEN- SIVE CHESS STUDY SEVERAL YEARS AGO, THE EPA INVESTIGATED THE HEALTH EFFECTS OF PHOTOCHEMICAL OXIDANTS. UNFORTUNATELY, ALTHOUGH THE RESULTS OF THIS RESEARCH PROGRAM COULD BE OF GREAT VALUE TO ALL CONCERNED WITH REASSESS- MENT OF THE OXIDANT STANDARD, NO INFORMATION OR CONCLUSIONS HAVE BEEN MADE GENERALLY AVAILABLE FROM THIS STUDY. IT IS ALSO WORTH NOTING THAT ALTHOUGH THE EPA HAS SET UP AND FUNDED SOME VERY USEFUL LONG TEEM RESEARCH PROJECTS, THE PROJECTS MAY BE TERMINATED BEFORE THE PROGRAM IS COMPLETE AND MAXIMUM BENEFITS CAN BE GAINED * FOR EXAMPLE, RECENTLY A MAJOR SEVEN YEAR ECOSYSTEM STUDY SPONSORED BY THE EPA WAS TERMINATET) AFTER ITS SIXTH YEAR --- JUST WHEN ANALYSIS OF THE DATA, ACCUMU- LATED AT EXPENSE AND EFFORT, WAS TO BE ANALYZED AND UTILIZED IN THE DEVELOP- MENT OF A MODEL OF POLLUTANT DAMAGE TO FOREST ECOSYSTEMS -- THE ULTIMATE PROJECT GOAL. THIS TERMINATION, ACCORDING TO THE EPA ITSELF, WAS NOT BASED ON TECHNICAL GROUNDS OR THE QUALITY OF THE PROGRAM. ALTHOUGH THIS ILL-TIMED AND ILL-CONCEIVED DECISION WAS SUBSEQUENTLY REVERSED, TEE INTERRUPTION OF FUNDING CAUSED MAJOR DELAYS AS WELL AS GREAT CONCERN AMONG THE TECHNICAL TEAM ON THE PROJECT, SOME OP WHOM HAD TO BE LAID OFF AND SUBSEQUENTLY REHIRED. PAGENO="0148" 142 (2) A "CATCH 22" PHILOSOPHY PRESENTLY EXISTS IN TERMS OF ASSIGNING WHICH FEDERAL AGENCY IS RESPONSIBLE FOR THE CONDUCT OF FUNDAMENTAL RESEARCH IN AIR POLLUTION. MANY TINES COLLEAGUES OF MINE HAVE SUGGESTED RESEARCH PROGRAMS IMPORTANT TO THE ELUCIDATION OF HEALTH EFFECTS, FOR EXAMPLE, ONLY TO HAVE EPA STAFF SAY, "THAT IS TOO FUNDAMENTAL; IT SHOULD CO TO THE NATIONAL SCIENCE FOUNDATION." IMAGINE ONE'S DISTRESS WHEN ONE SUBMITS THE SAME PROPOSAL TO THE NATIONAL SCIENCE FOUNDATION AND LEARNS THAT "IT IS TOO APPLIED; IT SHOULD GO TO THE EPA". LET ME CITE A SPECIFIC EXAMPLE WHICH HAS FAR REACHING AND DEEPLY DIS- TURBING CONSEQUENCES. THE CLASS OF COMPOUNDS KNOWN AS NITROSAMINES HAVE BEEN RECOGNIZED FOR OVER TEN YEARS AS VERY POWERFUL CARCINOGENS IN ALL TYPES OF ANIMALS. ONE WOULD THU$ EXPECT THAT STUDIES OF THE LEVELS OF NITROSAHINES IN AIR, WATER AND SOIL, AS BY PRODUCTS OF INDUSTRIAL PROCESSES, WOULD HAVE BEEN ONE OF THE EARLY HIGH PRIORITY ITEMS FOR EPA RESEARCH. HOWEVER, IT FELL TO THE NATIONAL SCIENCE FOUNDATION (RANN) THROUGH ITS "CHEMICAL THREATS TO MAN AND THE ENVIRONMENT" PROGRAM TO RECOGNIZE THE URGENCY OF THE PROBLEM AND TO FUND A LONG-TERM RESEARCH EFFORT DEALING WITH THE ROLE OF NITROSAMINES, AND THEIR PRECURSORS, IN THE ENVIRONMENT. TODAY THIS WORK OF DR. DAVID FINE AND HIS COLLEAGUES, SUPPORTED BY NSF(RANN) AND CURRENTLY BY NSF(ASRA), IS RECOGNIZED IN THE SCIENTIFIC AND MEDICAL COMMUNITY AS HAVING PAID GREAT DIVIDENDS IN THE PROTECTION OF THE GENERAL PUBLIC, AS WELL AS SPECIFIC OCCUPATIONAL EXPOSURE GROUPS SUCH AS MACHINISTS, FROM THIS DANGEROUS CLASS OF COMPOUNDS * FURTHERMORE, AS PART OF THEIR RESEARCH DR. FINE AND HIS ASSOCIATES PROPOSED INEXPENSIVE BUT HIGHLY EFFECTIVE PROCEDURES WHICH WOULD ELIMINATE TEE EXPOSURE OF THESE MACHINISTS TO NITROSAMINES IN THE CUTTING FLUIDS THEY EMPLOY. PAGENO="0149" 143 IN LIGHT OF SUCH CONTRIBUTIONS, IT COMES AS A GREAT SHOCK TO LEARN THAT THE CHEMICAL THREATS TO MAN AND THE ENVIRONMENT PROGRAM WILL BE TERMI- NATED AT THE END OF THE CURRENT FISCAL TEAR. WHERE THEN, ONE MIGHT WELL ASK, WILL SCIENTISTS GO IN THE FUTURE TO SEEK SUPPORT FOR SUCH INNOVATIVE AND RELEVANT RESEARCH? WILL THEIR IDEAS BE CLASSIFIED AS "TOO APPLIED FOR THE NATIONAL SCIENCE FOUNDATION" AND "TOO FUNDAMENTAL FOR THE EPA"? IN MY OPINION BOTH AGENCIES SHOULD BE SUPPORTING FUNDAMENTAL AND APPLIED RESEARCH * INDEED, ANY REDUNDANCIES WOULD BE WELCOME, AS THE OPPORTUNITY TO COMPARE AND CONTRAST RESULTS FROM PARALLEL PROGRAMS IS ALL TOO INFREQUENT IN AIR POLLUTION. (3) IT IS OF INTEREST THAT MAJOR ELEMENTS OF U.S. INDUSTRY WHO ARE VITALLY AFFECTED BY EPA'S REGULATIONS --- E.G. THE ELECTRIC POWER UTILITIES, THE PETROLEUM COMPANIES AND THE AUTOMOBILE MANUFACTURERS -- ALL FUND MAJOR EXTRAMURAL RESEARCH EFFORTS ON THE NATURE OF POLLUTANTS AND THEIR HEALTH EFFECTS * FOR EXAMPLE THE ELECTRIC POWER RESEARCH INSTITUTE (EPRI) IS NOW SPENDING MILLIONS OF DOLLARS ANNUALLY IN UNIVERSITIES AND RESEARCH INSTITUTES ON PROBLEMS THAT EPRI DEEMS IMPORTANT (E.G. HEALTH EFFECTS) AND IN WHICH QUALIFIED RESEARCHERS ARE INTERESTED. THE INFORMATION DERIVED FROM THESE STUDIES WILL UNDOUBTEDLY BE OF GREAT VALUE. HOWEVER, A SERIOUS CONCERN IN THE SCIENTIFIC COMMUNITY IS THAT THERE IS NO COMPARABLE EFFORT SUPPORTED BY THE EPA. FOR EXAMPLE, I PERSONALLY KNOW OF A CASE IN WHI~H A HIGHLY COMPETENT MEDICAL RESEARCHER WHO ORIGINALLY HAD EPA SUPPORT, HAD HIS RESEARCH PROGRAM TERMINATED AND WAS UNABLE TO OBTAIN A NEW GRANT FROM THIS AGENCY * HE THEN TURNED TO EPRI AND OTHER INDUSTRY BASED FUNDING GROUPS FOR SUPPORT --- WHICH WAS GIVEN. IF SUCH ACTIONS DO INDEED SUGGEST A TREND, THEY RAISE THE DISTINCT POSSIBILITY THAT, IN THE NOT TOO DISTANT FUTURE A MAJOR PORTION OF THE DATA PAGENO="0150" 144 UPON WHICH AIR QUALITY STANDARDS ARE BASED WILL BE GENERATED BY THE PRIVATE SECTOR --- RATHER THAN BY THE GOVERNMENT AGENCY RESPONSIBLE FOR ESTABLISHING THE EFFECTS OF AIR POLLUTANTS ON PUBLIC HEALTH. IN THIS CONTEXT IT IS IMPORTANT TO RECOGNIZE THAT DURING THE 1950'S AND 1960'S MAJOR RESEARCH CONTRIBUTIONS IN ALL ASPECTS OF THE AIR POLLUTION PROBLEM --- EMISSIONS, TRANSPORT, ATMOSPHERIC REACTIONS, INSTRUMENTATION FOR MONITORING, ELUCIDATION OF EFFECTS ON MAN, ANIMALS AND AGRICULTURE AND RELATED SOCIO-ECONOMIC ASPECTS --- CAME FROM THE U.S * UNIVERSITY COMMUNITY. FURTHERMORE, THE WORK OF FACULTY RESEARCHERS, ASSISTED BY GRADUATE STUDENTS AND POSTDOCTOR~ FELLOWS, WAS FUNDED TO A GREAT EXTENT BY AGENCIES WITHIN THE PUBLIC HEALTH SERVICE ANT) ESPECIALLY BY THE NATIONAL AIR POLLUTION CONTROL ADMINISTRATION. TODAY, DESPITE RECENT INCREASES IN FUNDING BY CONGRESS, I REGRET TO SAY THAT THE PROBABILITY OF OBTAINING UNSOLICITED, LONG-TERM FUNDAMENTAL RESEARCH GRANTS IN AIR POLLUTION FROM THE EPA -- PROPOSALS THAT HAVE TO PASS THROUGH AN INDEPENDENT PEER REVIEW SYSTEM --- SEEMS SMALL OR NON-EXISTENT, TO MANY TOP-NOTCH UNIVERSITY RESEARCHERS. IN CLOSING MAY I REPEAT THAT I APPRECIATE THIS OPPORTUNITY TO EXPRESS MY VIEWS, WHICH HOPEFULLY MAY BE OF SOME USE IN YOUR CONSIDERATION OF POSSIBLE APPROACHES BY WHICH THE EPA MAY OPTIMIZE ITS RESEARCH AND REGULATORY RESPONSIBILITIES. THANK YOU. PAGENO="0151" 145 NITRiC ACID FORMALDEHYDE BACKGROUND 9:20AM 2Oppb 36ppb 4:18 PM (PEAK OF SMOG) 49ppb 7lppb I I L~I I 890 905 2775 2785 cm~' cm~ Infrared spectroscopic identification of nitric acid (1~NO3) and formaldehyde (HCHO) in photochemical smog. --Claremont, California, October 13, 1978 PAGENO="0152" 0~ 0. z I 0 0 0 I .0 0. 0. r~) 0 z I -o 0. 0. 0 0 I .0 0. 0. w z 0 N 0 Concentrations of ozone and other toxic pollutants present in photochemical smog (i.e. photo- chemical oxidant) determined with 1 kilometer path length, Fourier transform infrared spectroscopic system. --Claremont, California, October 1978 PAGENO="0153" 147 Dr. Pirrs. I will go to page 2, the problem of the air quality standard for oxidant/ozone. For the past 2 years a number of researchers involved in various aspects of air pollution-from health effects to atmospheric chemis- try-have been deeply concerned over the possibility that the EPA might significantly relax the national air quality standard for oxidant, originally promulgated in 1971 to protect the public from the health effects of photochemical smog. These concerns were stimulated by two changes discussed within the EPA and its advisory committees, as well as in the scientific community at large: First, to regulate the spe- cific compound ozone, rather than the `collection of species generally termed photochemical oxidant, and second, to raise the existing primary standard which, as you know, is based on health effects data. On June 22, 197~, EPA first proposed to implement both of these changes by raising the standard to 0.10 ppm ozone. On January 26, 1979, this was formally increased to 0.12 ppm ozone. On August 24, 1978, Dr. Arthur Winer and I, acting in our capaci- ties as atmospheric chemists, testified at an EPA hearing in Los Angeles on the proposed changes. We pointed out that our prime con- cern was not the proposed shift at that time from 0,08 ppm to 0,10 ppm-although we strenuously opposed any value higher than 0.10 ppm-but rather the critical substantive change from photochemical oxidant to ozone. We stated: The health impact of photochemleal air pollutant results not just from o~one but from the entire spectrum of gas phase and particulate po1lutan~s which ~o- exist with it in ambient smog. Thus, although some laboratory investigations involving `human exposures have apparently not demonstrated "significant" effects at levels below about 0.25 ppm, we understand that certain of these studies were carried out with healthy subjects breathing ozone-air mixtures-not with "pulmonary risk" subjects breathing real photochemical smog or a surrogate for smog. I have attached to today's statement, Mr. Ambro, some new infrared spectra of potentially toxic trace pollutants that were taken at Clare- mont, Calif., October 12 and 13, 1978. Essentially, what we do is pass an infrared beam through the smog over a distance of about 1 kilometer; this gives us high sensitivity and by our infrared techniques we can "fingerprint" the chemical species present. If you will turn to the end of my formal testimony you will see these "fingerprints." The top curve is the reference spectrum, that is, the background befOre the smog came in. Now, if you look at the spectra taken at 9:20 a.m., the arrows indicate 20 ppb [parts per billion] of nitric acid and 36 ppb of formaldehyde. At 4:18 in the afternoon these rose.to 49 ppb of nitric acid in the air along with the ozone, as well as 71 ppb formaldehyde. On the next page are actual plots of the concentrations of these compounds, as well as formic acid and peroxyacetyl nitrate [PAN], as a functionof the time of day. You can see how the levels rise during the daylight hours and fall at night. Obviously we will not have time to go into details, but I wanted to show you there is hard spectroscopic evidence for these toxic, or po- tentially toxic, compounds being present along with ozone in real photochemical smog. PAGENO="0154" 148 One interesting point, if you add up the concentrations of these co pollutants you will find when the ozone level in Claremont was 0 12 ppm-that is the new air quality standard-the sum of formaldehyde nitric acid, formic acid, and PAN was 01 ppm One was breathing al most as much of these pollutants as of the ozone itself. In short, revising the standard from 0.08 ppm ovidant to 0.12 ppm ozone is tantamount to a de facto increase in the allowable levels of all of these other toxic or potentially toxic pollutants, they go together Let me point out some of the consequences of this fact There are two major factors involved in the change in the air quality standard One is a change in the actual number itself It ~ as raised from 008 to 012 ppm I am not going to discuss this in detail because I do not think that it is as important as the other change, namely the manner in which the air quality standard is now going to. be written. Previously, it was written as photochemical oxidant and it included, along with ozone, all of these compounds I have discussed with you, and more When one goes to ozone alone, one is dealing with an artificial atmosphere, that is, ozone in air. In a sense it deals with a synthetic world, one does not have a situation comparable to what the public faces in the real world Starting at the top of page 6 of my written testimony we make this point to set an air quality standard for a given pollutant, one re quires, among other data, detailed air quality measurements for that pollutant at various locations and times However, in the absence of an air quality standard for a pollutant, the EPA is generally not re quired to expend a significant effort to measure its atmospheric levels and health effects In other words, if a pollutant is not regulated, you are not required to measure it-but until you have measured it, it cannot be regulated. In view of these considerations it is clear why we were deeply dis tressed at Mr Costle's announcement on January 26, 1979, that the new air quality standard will be 012 ppm of ozone As we predicted, shortly after his announcement, several consultants for industry were quoted in the press as saying that even 0 12 ppm of ozone was too strict and that in fact the air quality stanthrd should be 025 ppm This attitude seems remarkable when in California a first stage smog alert is called when oxidant levels, measured as ozone, reach 0.20 ppm and schoolchildren are prohibited from participating out- doors in physical education classes This alert level is based on the miserable experiences of healthy people exercising in real smog-not to mention asthmatic children, those with emphysema, et cetera It is not based on people breathing artificial atmospheres of ozone in air, in artificial chambers We sincerely hope that during the ensuing months Mr Costle will review this issue and ievise the air quality standard back to photo chemical oxidant measured as ozone Now, let us turn to the next general area, the role of the EPA in fundamental and applied research relevant to air pollution. Turning to page 7 of my printed testimony, the main point is stated in the first sentence-"The maior problem in developing, assessing, and pro mulgating air quality standards for air pollutants has been and, as is clear from the oxidant discussion heretofore, continues to be the lack of a reliable data base concerning the health effects of these pollutants PAGENO="0155" 149 This reflects the lack of well managed, medium to long term, for ex~ ample, 5-year research programs, necessary to generate a reliable data base upon which can be developed air quality criteria and, I should stress, rational and cost-effective air pollution control strategies. To endanger public health would be tragic, but to overkill by excessively stringent standards would put an unnecessary economic penalty on the public. Thus we need a reliable data base established over a period of time so that when representatives of various parts of the scientific community, the EPA, industry, universities, et cetera, testify to you gentlemen we can all speak from a common data base- one that is accurate and comprehensive. This would permit us to make improved predictions for your use as policymakers, as well as for the EPA Administrator, Mr. Costle-for whom I have a great deal of sympathy in this debate. One of his problems, and that of his scientific staff, with this whole oxidant issue is exactly this-the data base on health effects is poor. One of my concerns in terms of EPA research is that for many years now the EPA has put a great deal of money into health effects studies of oxidants but unfortunately, the results were not very useful to those of us on the Advisory Committee of the EPA who were examining all available data. Indeed,, data from some of these research programs were simply not available in useful form. This created a difficult situation. In this respect, one major program you and your subcommittee should examine is the so-called CHESS program for determining health effects of photo~hemical oxidant [Community Health Envi- ronmental Surveiilan~e System] which the EPA initiated and managed. Unfortunately, although this program apparently was com- pleted several years ago the results are not available as yet to ad- visory committees or the public. I do not mean to he overly critical, however, because the design and execution of such large scale and complex efforts is a very difficult task. My point is simply that we need more long term, well designed, and well executed research programs that address issues that are very fundamental to the health effects of smog. It is also worth noting that, although in the past the EPA has set up some very useful projects-it is not that key health issues have been ignored-a major problem is that such projects often are terminated before the entire program can be completed and before maximum benefits can be obtained. Let me give you an example. Recently a major IT-year ecosystem study was sponsored by the EPA to study the effects of photochemi- cal smog on an entire region of the San Bernardino Mountains. This is an important recreational area downwind from Los Angeles. For example, more "people-days" are spent in that national forest than anywhere else in the United States. Six years of research were carried out in this program. Then, re- cently, the EPA terminated it, 1 year ahead of completion-just when the data, accumulated at great expense and effort, was going to be analyzed and utilized in the development of a most important model of pollutant damage to forest ecosystems. I need go no further to indicate the trauma this caused to the en- tire research team. Subsequently, the program was reinstated and the PAGENO="0156" 150 last year was funded, but only after people were laid off and difficult times ensued. Now, let me comment on another general problem which involves the conduct of air pollution research in the United States today as supported by various Federal agencies. A catch-22 philosophy seems to operate in terms of defining which Federal agency is responsible for the conduct of fundamental research in air pollution. Many times colleagues of mine have suggested re- search programs, some potentially very important to the elucidation of health effects of smog, only to have EPA staff say, "That is too fun- damental; it should go to the National Science Foundation." Imagine one's distress when one submits the same proposal to the National Science Foundation and learns that "It is too applied; it should go to the EPA." Let me give you a specific example where research that has im- portant implications to public health might fall through such bureau- cratic cracks. Consider the class of compounds known as nitrosamines. These have been recognized for over 10 years as very powerful car- cinogens in all types of animals. One would thus expect that studies of the levels of nitrosamines in air, water, and soil as byproducts of in- dustrial processes would have been one of the early high priority items for EPA research. However, it fell to the RANN Division of the National Science Foundation through its "Chemical Threats to Man and the Environment" program to recognize the urgency of the prob- lem and to fund a long-term research program dealing with the role of nitrosamines and their precursors in the environment. Today, the work of Dr. David Fine and his colleagues, first sup- ported by NSF-RANN and currently by NSF-ASRA, is recognized by many in the scientific and medical community as having paid great dividends in the protection of the general public, as well as specific occupational exposure groups such as machinists, from this dangerous class of compounds. Furthermore, as part of their research Dr. Pine and his associates not only identified the problems but also came up with effective solutions to deal with them. For example, they also showed that nitrosamines were present in large and frightening quan- tities in a widely used herbicide. They then proposed an inexpensive but highly effective procedure to eliminate the carcinogen-one simply changed the containers in which the cutting fluid was stored, going to a plastic-lined can so that sodium nitrite was no longer required as an antioxidant. That solved the problem. In light of such contributions as this, it comes as a great shock to learn that the chemical threats to man and the environment program will be terminated at the end of the current fiscal year. Where then, one might well ask, will scientists go in th~ future to seek support for such innovative and relevant research? Will their ideas be classed as "too applied for the National Science Foundation" and "too funda- mental for the EPA?" I should note, however, that Dr. George Pimental. Deputy Director of the National Science Foundation, has recently told me that, in fact, proposals for research in areas previously in the Chemical Threats program would be sent to other NSF divisions. including their Di- vision of Applied Science and Research Applications IASRA]. PAGENO="0157" 151 It was good news to hear this. Furthermore, Dr. Pimental made another important point. The NSF will continue to be receptive to re- ceiving from qualified researchers all types of unsolicited, imaginative research proposals in the environmental sciences. Actually, in my opinion, both agencies, the EPA and NSF, should be supporting both fundamental and applied research in air pollution. Indeed, and I want to underscore this point because I think Govern- ment administrators often get unduly upset over redundancy in re- search, some overlapping of research efforts between these, and other agencies would be welcome. The opportunity to èompare and contrast the results from parallel programs is all too infrequent in the air pollu- tion field. Indeed, I would welcome two parallel studies on health effects of photochemical oxidant conducted in different laboratories. Decisions on air quality standards depend on such information and may involve billions of our dollars as well as the public health. It would be highly gratifying to see mutually confirming results coming out of two independent research efforts. The last point I want to make is this. It is of interest that major elements of tT.S. industry who are vitally affected by EPA's regula- tions, that is the electric power utilities, the petroleum companies and the automobile manufacturers, all support major extramural research efforts on the nature of pollutants and their health effects. For example, the Electric Power Research Institute is spending millions of dollars annually in universities and research institutes on problems, for exam- ple, health effects, that EPRI deems important and in which qualified researchers are interested. The information derived from these studies will undoubtedly be of great value. However, a serious concern in the scientific community is that today the EPA is not supporting a comparable effort in our uni- versities. For example, I personally know of a case in which a highly competent medical researcher who originally had EPA support, had his research program terminated and was unable to obtain a new grant from this agency. He then turned to EPRI and other industry based funding groups for support-which was given. Now, if such actions do indeed suggest a trend, they raise the distinct possibility that in the not too distant future a major portion of the data upon which air quality standards are based will be generated by the private sector-rather than by the Government agency responsible for establishing the. effects of air pollutants on public health. As a sort of final line illustrating my point, despite recent increases in funding by Congress, the probability of obtaining unsolicited, long term fundamental grants for air pollution research from the EPA- grants that must go through an independent extramural peer review system like that of the Public Health Service or the NSF-seems small or nonexistant, at least to the many top-notch scientists in the United States today. In closings may I say that I appreciate this chance to be present today to express my views. I hope they will be taken in the helpful manner in which I have intended to advance them. Thus, I have great respect for the EPA and many of my friends and colleagues over there. They are on the "front line" of a very demanding situation in which they have to be concerned with a proper balance between energy, environmental PAGENO="0158" 152 and economic constraints. That is a great deal more difficult than the lot of a university professor such as myself who comes here and testi- lies. Mr. AMBRO. Doctor Pitts, I want to thank you for taking time to do this and thank you for your statement which as 1 said at the outset will be incorporated into the record. A couple of questions with respect to the oxidant. standard. Do you think that the proposed revised standard provides protection against intense visibility loss from photochemical smog.? Dr. PITTS. That is a good question. Any increase in oxidant levels in photochemical smog usually involves a corresponding decrease in visi- bility. Thus the answer is that if the smog were 0.08 ppm one would in almost all cases have better visibiliy than if it were 0.12 ppm. Mr. AMBRO. On the same subject, will the revised oxidant standard in your opinion provide protection against say eye irritation in places as far apart as Washington, D.C. and Los Angeles? Dr. PITTS. That is the bottom line. My concern is that when one shifts from oxidant to ozone one is shifting to an artificial situation. Ozone is. not an eye irritant~ However, certain other species present in oxidant such as PAN and formaldehydeare lachryrnators. So the shift frOmoxidant to ozone would, at the least, imply less emphasis on, and control ~f eye irritants. :Mr, AMBR0. The EPA budget seeks a substantial increase in health effecth research. Will that new budget in your opinion provide the funding for de- veloping a less miserable data base on health effects? Dr. PITT5. It may provide the funding, but unless it is accompanied by very strict management by people who understand how to manage scientific research-and with the philosophy that says we will fully support this research for the number of years that are necessary to complete the effort, analyze the results and make them generally avail- able to the ~cientiflc community and public officials-unless those things happen oneT~ould have millions go down the drain, Mr. AMBRO. how long would it take to provide or establish a data base, that is of qualityt Dr. PrrTs; Perhaps 3 to 5 years, but for the biological and medical side of health effects research I think you should ask Professor Whittenberger. Let me make another point. In considering health effects one deals with dose-response curves. Our job as atmospheric scientists is t~ de- fine the dose portion-for example what are the chemicals and what are their physical forms at the point where they are inhaled through one's nose and mouth. Characterizing the chemical and physical aspects of the "dose" ib complex, as you see from our infrared spectra of ambient smog, but it is a less complex and demanding task than establishing the health effects of these pollutants on man. I would say one is talking intermns of 3- to 5-year programs for making a significant improvement on specific pollutants. In such a time frame one will probably not discover the detailed mne4~hanism of cancer formation in man-but in a well conceived and executed 3-year program one could, for example, explore a number of aspects of the relative health effects in animals of diesel exhaust versus PAGENO="0159" 153 that from a spark-ignition engine. Basically, one could use laboratory dynamometers and run a diesel alongside a spark-ignition engine for the same distance and the same rate of speed, expose paired sets of animals to the two exhausts, and then look for relative effects such as possible formation of cancers, emphysema, et cetera in the two popu- lations-and, of course, the control group. Actually, the EPA has a fine laboratory in Cincinnati, set up some years ago to perform this very experiment. The research staff are first class pathologists, engineers, chemists, et cetera. Apparently they were well into the program several years ago but their funds were cut off. Then all of a sudden the diesel exhaust flap hit and now pressure is put on for a crash program to go back and start it up again. That is a real concern-those data, diesel versus spark-ignition engines, would be most valuable today to scientists, control agencies and public officials who are deeply concerned with the energy-economics-environmental impacts of the two types of engines. Let me make another point, however2 in defense of the EPA ad- ministrators. The EPA has set up some first class programs with some first class scientists and engineers deeply involved in them. But, some- where along the line Congress encounters a new and potentially im- portant environmental issue-for example, the fluorocarbon problem. The possibility of serious depletion of the ozone layer is raised and the problem gets dropped on the EPA on an "emergency" basis-with perhaps little or no increase in skilled manpower assigned to them to tackle this very complex issue. The EPA administrators then have to make crucial decisions as to how to realign their ongoing research programs and staff to meet the new concern of Congress-quite kgit- imate, I stress-about the stratosphere. While speaking of the impact of anthropogenic emissiOns on the stratosphere, let me illustrate to you how important good, funda- mental research can be in deciding problems of great economic impoi~t. All of us remember the SST problem. Based on the best data avail' able around 1970 it was proposed that their emissions of oxides of nitrogen might seriously deplete the stratospheric ozone layer. Then, a "funny thing happened on the way to the laboratory" 2 years a~go. Simultaneously at Cambridge University in England and at U.S. Government laboratories in Boulder, Cob., teams of scientl9ts ifl~ dependently determined a new value for the rate of a crucial reaction. It was 30 times higher than the old value. When this new chemical information is inserted into the stratospheric model, using the same rules for the modeling game the SST now makes ozone! I am nOt criticizing the earlier researchers, because they used the best data available at that time-and in a scientifically sound manner. But, it is clear one has to be very careful when one draws scientific concitsiolis of major importance based upon a technically weak data base. Mr. AMBRO. You just made the strongest argument for reconsider- ing the B-i bomber. I will not dwell on that, but just one last question. with respect to this management problem. Give us your views as to why projects are terminated before the program is completed. We will try and figure out who they are, but give us a clue as to where to look. Dr. Pirrs. Part of the problem inherently lies inthe structure of the EPA. One has in the top level EPA administration in Washington a PAGENO="0160" 154 number of lawyers-first class professiomds-but--generally-~ not trained as scientists. Then at the various EPA laboratories throughout the United States one gets down to the level of the working scientist. It seems to a significant fraction of the extramural scientijic com- munity that there may be a lack of communication up and down this whole, very complex structure. Furthermore, and let me stress that as a university professor with tenure and not on the firing line of real world control actions, I'm very sympathetic to EPA administrators who have great responsibilities- at times there seems to be what some consider to be undue sensitivity on their parts to crash programs proposed by you Congressmen and to some of your committees. Thus the EPA will get some first-class, long-term research programs set up and just as they are running well, another most urgent directive comes down from you. The EPA response may be-and I fully understand and sympathize with the EPA-"Now we have to alter our programs and priorities to look at a new crisis !" Well, that affects the top management-and things filter down. Thus instead of Congress or the executive branch mandating, for ex- ample., "You must study fluorocrabons on a crash basis but you can't have significantly more seientific manpower," I would hope such requests would be in terms of "We in Congress need this information, and will provide additional manpower and funds so that we do not disturb your current critical, ongoing, long-term research programs." Maybe the EPA needs more insulation to protect their long-term re- search missions. Mr. AMBRO. I will turn it over to Mr. Walker at this point. Mr. WALKER, I will pursue that for a minute, please. There is a ques- tion I jotted down to myself concerning the dollars that have gone into research and the data base that is not there when needed. Is part of that a response to the legislative system that demands ac- tion on something that all of a sudden becomes highly visible in the domain? The regulations are then written before any data base is developed. Dr. Pirrs. In terms of the lack of a comprehensive and reliable data base, that may, in some instances, be correct. Someone will discover a new toxic compound and all of a sudden EPA is told do something about it on a crash basis. Your point is well taken-the EPA scientists now have to go to the literature, but all too often, few reliable data are available for an accurate assessment. Nevertheless, the EPA has to do something fast. Mr. WALKER. In that case the legislative process is really frustrat- ing, because here we are, dumping money into research which may never be able to be used, because we have trouble modifying regula- tions once they become law, because we start hearing then about back- ing off on commitments made and all this kind of thing, regardless of whether research down the pike shows those regulations to be on base. Dr. Prr'rs. That is why one needs several types of effort in the EPA. One needs unsolicited, extramural, long-term, fundamental efforts that are handled-as with the NSF-under a strict peer review system. One also requires short-term, highly directed research programs handled by the EPA in-house, or through specific contracts. Finally, the EPA needs a range of research efforts that fall in between these extremes. PAGENO="0161" 155 Mr. WALKER. If we were wise in terms of responding to something that becomes publicly visible in the environmental area, what we should be doing would be authorizing additional funding initially in order to get the required data base. Dr. Pirrs. Yes. Mr. WALKER. Let me ask another kind of follow-through question on that. I have understood that there are some research efforts within EPA that come up with data which EPA does not want to have pub- lic, and that data then gets buried, because it does not fit the direction that the regulations are going to go, and that direction is impossible when much of the data looks like that, Is that a problem you have observed ~ Dr. Pirrs. Well, I prefer to have the EPA answer that question. I know of one instance that you may be referring to-natural versuS anthropogenic hydrocarbons in smog formation. However, since ap- parently there are law suits dealing with this issue perhaps the EPA should respond. However, I will say this: I think the response of the EPA staff scientists involved with that particular issue was honest. In my personal opinion, they are not suppressing data and they are prepared to discuss all aspects of the issue. Let me also say this: Never in my contacts with them have I seen EPA scientists and administrators suppress or bury data, nor have I ever heard of anyone in the EPA talk about doing so. Mr. WALKER. Thank you, Mr. Chairman. Mr. AMBRO. Mr. Watkins? Mr. WATKINS. Thank you, Mr. Chairman. Welcome, Dr. Pitts. I have a concern about this and I would like to ask you some questions here. Does there need to be a longer period of time to establish reliable data? For how long a period ol time was data collected for the current ozone standard to be reached? Dr. PITI~. Some of the data used in 1971 in setting the first air quality standard was taken around the midfif ties or late fifties. One of the recent concerns that bothProfessor Whittenburger and I had-hav- ing been involved with the first air quality criteria document-was that when discussions of a possible revision took place last year our Ad- visory Committee was handicapped by the lack of a substantial im- provement including new additions to the data base on health effects of oxidant. Mr. WATKINS. What specific events of last year are you talking about? Dr. PITTS. Those dealing with the oxidant-ozone air quality stand- ard. There was an EPA Science Advisory Committee that was charged with reviewing and evaluating existing information on photochemical oxidant to assist Mr. Costle in making his decision on the air quality standard. Mr. WATKINS. Wasn't the criteria document completely rejected 3 times by the science advisory board on that, and found unaccept- able? Dr. Pirrs. Certain aspects of it were not acceptable to me and others. Mr. WATKINS. It is true they used the Adams study? 43-778 0 - 79 - 11 PAGENO="0162" 156 Dr. Pirrs. I cannot go into that as I do not have the expertise in that area. Ask me about the chemistry and I will be glad to respond. Mr. WATKiNS. I agree with you on this thing. I think the data base is miserable. Dr. Prrrs. It is tough on everybody. It is tough on industry and on the EPA. Mr. WATKINS. It is going to be tough on the pine trees in my part of the country, because in this natural area, the national park has an ozone level that exceeds the revised standard. In your testimony you are saying we have to keep it below 0.12, that we cannot go up to 0.25, when most studies have looked at 0.25 and say it does have adverse health effects on the population. Dr. Pn'rs. That may be true if, in fact, it is ozone alone one con- siders. That is the problem. If it is oxidant containing all these com- pounds I have shown you today I am sure that some healthy people in a photochemical smog attack in Denver, Cob., for example, will get sick playing tennis, jogging, or engaging in other active forms of exercise. Thus 0.20 ppm of oxidant is a first stage alert in California. Mr. WATKINS. The standard that Dr. Costle proposed the other day in his press release was based on ozone. Dr. Pirrs. Yes. Mr. WATKINS. It was 0.12. You disagree with that also. Dr. Prrrs. I disagree with the ozone part of it. I feel it should be written as oxidant as it was in 1971 and be. set no higher than 0.10 ppm. Mr. WATKINS. But this standard is for ozone at 0.12, which has no scientific, intellectual integrity about it as such, and there are studies that prove you do have any adverse effects at 0.25 and 0.30 and the standard is therefore unbelievable. Dr. Pirrs. We have made this point to EPA, and it has been on the record for over 2 years. If the EPA changes from oxidant to ozone, one is changing the standard from one reflecting the real world to one reflecting an unreal situation. Furthermore, when one takes that action we have consistently pointed out that the EPA is wide open for attack. I feel that the EPA cannot make a legitimate defensible stand- ard on the basis of only ozone in air. So you are right in one sense, the new standard should not have been for ozone alone. The trap was sprung. Industry can sue by the way, and I hear that they may do so. Their lawsuit, i~ the standard remains written as ozone, will be interesting indeed. As I said earlier today, I feel the standard should be 0.10 ppm oxidant me.asured as ozone. Mr. WATKINS. The basis for the revised standard is unbelievable, and if I were a scientist in this room and dealt with this I would high- ly question Dr. Costle's opinion and that of his people, because the en- tire scientific community's integrity is at stake. Dr. PITTS. Well, on February 22, 1978, in a mee.ting of an EPA ad- visory committee when we reviewed this document, Dr. Whittenberger and I made several of the major points I presented today. They were not acted on-but of course we were simply acting in an advisory capacity. Mr. WATKINS. I have a lot more questions for Dr. Whittenberger be- cause I have been reading more of his comments and background, and PAGENO="0163" 157 I know he is a member of the SAB, which as been set up to review the criteria documents and the standards. The flat statement to be. made here by my colleagues is that the EPA has violated the. law in setting these standards on ozone. Mr. AMBRO. Well, rather than get into litigation let us proceed. Mr. WATKINS. Mr. Chairman, that is all I have at this time. Mr. AMBRO. Thank you, Dr. Pitts. We have a colleague here, my dear friend from New York, Mr. Lundine. Mr. LTJNDINE. I have no questions. Thank you, Mr. Chairman. Mr. AMBRO. Again, Dr. Pitts, 1 hope you make your plane. Is Dr. Johnson here yet? [No response.] Let us proceed with Mr. Flynn, chairman of the Suffolk County Water Authority and wait for Dr. Johnson's arrival. We will also hear from Foster S. Burba, president, Louisville Water Co., Louis- ville, Ky. As we all know, EPA has proposed standards for contaminants in drinking water and yet, there is no practical water treatment equip- ment available at reaJistic cost that will enable a water authority to meet these standards. This specific drinking water problem is typical of a broad range of problems in which EPA is better able to identify potential hazards than to correct them. So, with my pet peeve on the record, I would like to ask Mr. Flynn first to provide us with his statement and then I will call on Mr. Burba and we will open into questions both for Mr. Flynn and Mr. Burba. STATEMENTS OP A PANEL ON DRINKING WATER, CONSISTING OP ROBERT ~. FLYNN, CHAIRMAN, SUFFOLK COUNTY WATER Au- THORITY, HUNTINGTON, N.Y., ACCOMPANIED BY WALTER HAZLITT, WILLIAM SCIIICKLER, AND AUGUST GUERRERA; AN]) FOSTER S. BURBA, PRESIDENT, LOUISVILLE WATER CO., LOUXS~ VILLE, KY., ACCOMPANIED BY GEORGE PENDYGRAPT Mr. FLYNN. Thank you, Mr. Chairman. Mr. Chairman and members of the subcommittee and others here who are dedicated to the delivery of pure drinking water and to the people of America. First, I would like to mention some of my colleagues from the Suffolk County Water Authority who are here with me. Our executive director, Mr. Walter Hazlitt, who served 5 years as chairman of our authority, ~~/2 years in t.he Suffolk County Legislature in whose predecessor, the Suffolk County Board of Supervis~a you and I both served, Mr. Chairman, and prior to that he was the manager of the Stony Brook Water District. Also with me is Mr. William Schickler, our chief engineer. It 1~as been his responsibility to design and monitor the construction of what is now the second largest water utility in the State of New York, exceeded in size only by the delivery system operated by the city of New York. As you are no doubt aware, Mr. Chairman, we now service 230,000 customers, spread over a county 90 miles long. PAGENO="0164" 158 The people of Suffolk live on top of a huge geological bowl contain- ing trillions of gallons of superb drinking water. Our financial advisors estimate that our physical plant has a value of about $2~0 million. We have 150 well fields and some 400 wells in operation. Our total delivery capacity is now about 500 million gallons a day. Last year we pumped o~er 32 billion gallons. I wish to stress the uniqueness of Suffolk County, its unique geology, its unique development of the water resource with many sources of sup- p1y interspersed within our distribution system. It can be easily seen therefore that we bear an extraordinary degree of responsibility to preserve and protect our water supply. The daily lives of almost 1 million people depend on it. So I trust that our comments here today will be accepted' in that light. We support the Pure Water Act. We join with everyone, any- where, and furnish all of our technical resources to insure the delivery of pure water and to fight any threat to the water supply. Remember, we are not dealing with the drawing of rules and regulations in the abstract. We have hundreds o~ people in our employ managing pump stations, laying mains, making service calls, and monitoring the quality everyday. We operate the most sophisticated bacteriology and chemistry labo- ratories on Long Island headed by our brilliant, nationally respected chief chemist, Mr. August Guerrera, who is also present here today. So we will take a back seat to no one when it comes to our desire to deliver pure water. Yet we do reserve a right to question the methods being imposed on water suppliers to protect the product. In fact, Mr. Chairman, there is almost an air of deja' vu about my testimony today. I am sure you can recall almost two decades ago when some voices cried'in the wil- derness trying to convince Suffolk County not to start the now tragic $1 billion sewer project, which is now, because of its expense, driving thousands of people from their homes and from neighborhoods where they were born and raised. One major voice urging moderation was that of our chief chemist, Mr. Guerrera, warning of the limited bene- fits of the reduced sewer project to protect the drinking water. I might also point out, Mr. Chairman, that the detergent ban, which you were supportive of, was originally suggested as a result of a study in which the Water Authority took `an active role. So I repeat, we have been out front consistently when it comes to protecting our water supply. There are two main thrusts to the proposed amendments to the interim primary drinking water regulations. The first deals with the proposed regulation to establish a maximum contaminant level of 100 parts per `billion for total trihalomethanes. Since we chlorinate we are affected by this regulation. We feel strongly that we can demonstrate that precursor compounds are not present, so that trihalomethanes will not be generated even with chlorination. We should be allowed to demonstrate this once, and then not waste our analytical capabilities in useless routine monitoring. The second thrust of these new regulations has to do with organia compounds which only recently were subject to detection and some of PAGENO="0165" 159 which still cannot be detected. We understand and accept this fact that this will be our ongoing problem for some time to come. In Suffolk County, the types of organic compounds so far detected have generally fallen into two categories: Industrial degreasers, such as the ethylenes; and other degreasing agents, such as methylene chlo- ride and the chloroethanes, which are presently packaged for the purpose of cleaning cesspools and opening clogged drains. Although no standards exist for these compounds, we have removed a few wells from service when concentrations exceeded a State guide- line of 50 parts per billion. We feel the industrial degreasers can be controlled by more rigorous enforcement of permit systems already in place. I should interject here that most of our problems to date stem from the degreaser type contaminant to which I just alluded. Hence, we have requested both our county legislature and our State legislature to ban their sale and use in our county. Such action by our legislators can have direct, positive effect of preventing future damage. We are also in the process of commencing a massive product liability suit against the manufacturers of these products. In other words we are not just standing around wringing our hands. We are taking steps to prevent the contamination of the ground water. We do not want to wait until we have to filter it. Thus, we are here today because we are different from most of the water suppliers to whom these regulations were addressed. The main area addressed by the proposed regulations is that of the water com- panies who obtain their product from surface waters. The comments accompanying the regulations all demonstrate that we are different and that' our problems are different. Yet, we are covered by this enor- mous regulatory blanket even though ~t was not designed for us. A simple analogy would be if the Department of Transportation determined that the skidding of automobiles `was a national hazard. It then determines that most skidding occurs in winter because of ice. It then decrees that all cars must have snow tires from November to April whether they are registered in the Florida Keys or Anchorage, Alaska. We have already furnished you, Mr. Chairman. with our cost esti- mates to install the GAO and to maintain it. However, we have examined with dismay, the EPA's estimates of cost both in the February 9, 1978, publication by Mr. Costle and the June 23, 1978, upward amendment of those projections by Mr. Jorhng. Taking Mr. Jorling's revised figures on page 27, he estimates that the national cost of having to treat for both trihalomethanes and organics would be from $616 million to $831 million. That is sup- posed to be national costs. Yet, we estimate that our cost alone in our county of 9~0 square miles will be $263 million to install the system. He estimates the annual expenses nationwide to maintain the sys- tem at $62 million to $86 million. We estimate our expenses alone to be $50 million. His annual revenue requirement is $124 million-$169 million na- tionally. Ours alone~ would be $60 million for maintenance. Our cost i~er family will not increase from* $7 to $23 per annum. Rather, it will be an increase of more than $200 per family per year. PAGENO="0166" 160 And, bear. in mind that the estimate is that for each 1 million- gallon-per-day capacity, we will need 50 tons of GAO. That would mean that we would need to obtain and consistently treat 25,000 tons of GAO. Now, I am sure that someone is going to tell you that if the financial p~cture is as bad as we paint it, we would be entitled to a variance. But, if you examine carefully the bases for variances, you will find that the authors of this legislation just do not want to let go corn- pletel~. By that I refer to the wording of section 141.54. It appears to provide that the State may grant us a variance if it is found that we draw our raw water from deer ground water. A careful reading of the section shows that this can be done only in the absence of information that our sources are subject to signifi- cant contamination from synthetic organic chemicals. What is signifi- cant? In whose opinion? We concede that in our neighbor, Nassau County and in a few places in our county, certain wells near some major industrial areas have been contaminated. Is that significant in relation to our wells in Montauk 100 miles away? Is it significant in relation to a well 2 miles away where tests show the water to be free from or~anics? Because I know time is important here today, Mr. Chairman, and you are anxious to devote a major amount of time to questions, let me sum up our position briefly. 1. The EPA has tried to be all encompassing with these regulations. They should have drawn up one set of reo'ulations to deal with sur- face water systems and another to deal wit'~i ground water systems. A review of these regulations clearly indicates that they are aimed at surface water systems but someone decided that they might just as well throw us and the Great Lakes into the environmental bouillabaisè. If another Federal agency such as the U.S. Geological Survey in- forms us that we are drawing water from a geological formation, where the water is several hundred years old, then the likelihood of encountering synthetic organic chemicals must be small. 2. The criteria for variances or exemptions should be clarified and enough flexibility allowed the local agency to grant variances or ex- emptiolis based on its knowledge of local geology without requiring the very expensive analyses of a laundry list of 114 "priority pollut- ants" and without requiring public notification. 3. We have every right to the presumption in our favor that we are doing and will do everything necessary to protect our water supply and our customers. We should be exempt from these regulations until the EPA proves that we should be subject to them. `lie way it stands now, we will have to spend millions of dollars to prove we are entitled to a variance. In other words, under these rules, we are guilty until we prove ourselves innocent. No one agency is the embodiment of all wisdom in this field. As I have indicated before, we were fighting to protect our water before most regulation writers learned how to spell "ecology." 4. The simple answer is to exempt us and the others listed under section 141.54(c) from these regulations until such time as the EPA has devoted the same time and effort to the conditions that apply to those classes of suppliers as it has to the surface water suppliers. PAGENO="0167" 161 And, at all times, bear in mind that there is not even a guarantee that if we spend $263 million that the proposed system will work. As indi- cated in the preamble, the authors feel pretty sure it will work but none knows for sure. If they are wrong and our cost figures are right, many centuries in the. future, visitors to Suffolk County like the thousands of visitors to Mexico who now examine the Mayan Pyramids and wonder what happened to that lost civilization, will wonder about 90-mile-long de- serted village and wonder what strange people built a $1 billion sewer system and $250 million filtering system and then disappeared leaving not a pyramid, but a mound of 25,000 tons of granulated activated carbon. Thank you again for your interest. We welcome any questions. Mr. AMBRO. I would like to call now on Mr. Foster S. Burba, presi- dent, Louisville Water Co. of Louisville, Ky. Mr. BURBA. Thank you, Mr. Chairman and members of the subcom- mitte. I think Congressman Walker has essentially given my talk with his comments on some problems regarding regulations and lack of research. I am Foster Burba, president of the Louisville, Ky., Water Co. which is owned by the city of Louisville. I appear here today on behalf of the American Water Works Asso- ciation, a scientific and educational society concerned with advance- ments in the public water supply field. Our 30,000 members are mostly managers, engineers, and other employees of water utilites, but also include scientists, consultants, manufacturers, contractors, and local, State and Federal government employees-all interested and involved in supplying water to the public. As public water suppliers, we are dedicated to providng drinking water that is safe, and at rates no higher than necessary. Additionaly, I am co-chairman of the Coalition for Safe Drinking Water which was formed to comment meaningfully and beneficially upon the pro- posed regulation to control organics in drinking water. On my right is Mr. George Pendygraft, attorney for the coalition. He has a Ph. D. in organic chemistry and since I wear two hats we have submitted two comments, one on behalf of the coalition which will not be presented orally, but it is given to you because it has con- siderably more technical information, more detailed information than this general information I am presenting today on behalf of the American Water Works Association. Mr. WATKINS [presiding]. The statement will be made a part of the record at this point. [The statement referred to follows:] COMMENTS OF THE COALITION FOR SAFE DRINKING WATER The Coalition for Safe Drinking Water is a nationwide group of some 90 municipal and investor owned drinking water systems. As public water suppliers, we are dedicated to providing drinking water that is safe, and at rates no higher than necessary. On February 9, 1978, the EPA proposed an amendment to the National Interim Primary Drinking Water Regulations. The Coalition's participation in this rule- making procedure has made it knowledgeable of several aspects of EPA's re- search and development ("R. & D.") programs. We would like to share with you PAGENO="0168" 162 some of our observations. They center on what we perceive as abuses which should be addressed by this Subcommittee. A first concern that we wish to share with you is EPA's funding and use of re- search and development studies whose primary purpose appears to be to support already proposed or promulgated EPA regulations. The House Appropriations Subcommittee on HUD and Independent Agencies notes this tendency In Its Committee Report on the fiscal 1979 Appropriation for the EPA, where 1* observed: EPA's research and development programs have been directed more toward a legal defense of regulations rather than Information for their development. . To give you some Insight on the problem. EPA through this regulation is pro- posing to establish a standard, a maximum contaminant level ("MCL"), of 100 ppb for trihalomethanes ("THM5"), a class of organic chemicals. EPA predicates this trihalomethane standard upon a hypothetical cancer risk. But there is no evi- dence that three of these trihalomethanes (bromoform, bromodichloromethane, chlorodibromomethane) are carcinogenic. For the other THM, chloroform, there is rather convincing evidence that it is not carcinogeilic. Indeed, the most in-depth studies made to date consistently showed that survival of the test animals was Improved by exposure to chloroform. EPA merely ignores this data. Instead, EPA chooses the rely upon a 1976 preliminary screening study to support its assertion that chloroform, and by inference all trihalomethanes, in drinking water are car- cinogenic. This preliminary screening study, performed by Hazelton Laboratories America, Inc., for the National Cancer Institute, was never intended to do more than identify those chemicals which need further research. The study was not in- tended to be used to extrapolate the health effects observed at extremely high dose of the tested chemicals to the very low levels that might be found In drinking water. The Director of NCI, himself, has admitted that the Hazelton bioassay on chloroform was "a preliminary screening test and not a definitive study." Yet, EPA proposed the regulation, relying totally on the Hazelton study, and then com- menced the required, in-depth research. In June 1978, EPA undertook to have Stanford Research Institute study the question of the carcinogerUcity of chloroform in drinking water. The cost of this study-$408,000--suggests its importance. In requesting those funds, EPA stated: [TJhe risk to ~iuman health from the possible carcinogenic impact to the human population cannot be completed without the data from the proposed SRI study. * * * All reviewers have agreed that the investigations will achieve the stated objectives of providing suitable data for the evaluation of any hazard or risk associated with chloroform as a carcinogen. We suggest that EPA has put the cart before the horse, by first proposing the trihalomethane standard and then doing the necessary research. Another example of EPA research now underway that should have preceded the proposed drinking water regulations is the National Academy of Science re- view of the adverse health aspects of the granular activated carbon treatment ("GAC") process, which the proposed drinking water regulation would require nationally. This study also was begun after the GAC requirement was proposed, So here, we have a new treatment process requirement being proposed before we iqiow whether the proposed "cure" is not worse than the presumed "problem." EPA's approach to research has another aspect we would like to share with you. If the research does not support EPA's hypotheses, EPA attempts to ignore or minimize its conclusions, even if EPA sponsored the research. For example, when EPA first proposed its drinking water regulations, It asserted that "based upon the epidemlological data presently available * * * the presence of organic chem- icals indrinking water may have an adverse effect on human health." This state. ment, very simply, is unfounded and was shown to be so by the Coalition's expert, Dr. Timothy DeRouen, of the University of Washington. His conclusions were supported three months later by the National Academy of Sciences Subcommittee on Epidemiology. The NAS Subcommittee was commissioned by EPA to review the existing epidemiological studies. In October 1978, this subcommittee reported that it was not possible to establish a link between the presence of trihalometh- anes or synthetic organic chemicals ("SOCs") normally found in drinking water and cancer in humans. EPA's response was that it really was not relying on epi- demiology studies, after all. The recently released epidemiological study by Pro- fessors Tuthill and Moore of the University of Massachusetts Is the most relevant epidemiological study of chlorination and cancer mortality to date. It is an eco- PAGENO="0169" 163 logical time-lag study to assess the cancer mortality of Massachusetts communi- ties exposed to chlorinated surface water supplies. Because it uses actual data rather than theoretical data, it is of great significance. It concludes that there is no evidence of statistical association between cancer and chlorination of drinking water. There are elaborate studies of chloroform underway at the Medical College of Virginia ("MCV"). A number of preliminary findings have been released. Be- cause of the breadth of the MCV studies, as reflected by its $500,000 cost, one would expect EPA to have followed the results closely. However, the results have been less than supportive of the proposed regulation and EPA has attempted to bury them.. A statement by the study's chief toxicologist suggests why. Dr. Joseph Borzelleca, the toxicologist heading the MCV research team, is reported to have concluded: "It's my feeling that there is a safe level for chloroform. You could never drink enough water to get an effect from it." EPA has ignored the conclusions of other National Academy of Sciences research teams when the answers were contrary to EPA's desires. The NAS Panel On Low Molecular Weight Halogenated Hydrocarbons ("Panel") was paid approximately $175,000 to assess whether the assumed benefits of the pro- posed drinking water regulations justify the cost of the regulation. The Panel concluded that a trihalomethane standard of less than 409 parts-per-billion was not cost-benefit justified if GAO were required. This conclusion obviously undermines the proposed THM standard. EPA has concluded that the study is not relevant. Using the Panel's methodology of assessing costs and benefits, it is a foregone conclusion that the GAC treatment is not cost effective in removing negligible quantities of other synthetic organic chemicals that might be found in drinking water. Needless to say, EPA has made no effort to use the Panel's methodology in connection with the proposed drinking water regulations. In some important respects, EPA has not even ordered essential research. In the proposed regulation, there are extreme uncertainties as to which synthetic organic chemicals might be present in drinking water, and whether or not the levels of such chemicals in drinking water constitute a potential health risk. The National Academy of Sciences has recommended further health effects re- search of synthetic organic chemicals. We agree with the statement of Stephen J. Gage of EPA, made before this Subcommittee on February 13, 1979, that EPA should predicate standards on "a scientifically valid data base relating adverse research effects to causative pollutant exposures. . . ." EPA has failed to provide this scientifically valid data upon which to predicate the proposed drinking water regulations. To deal with synthetic organic chemicals in drinking water, EPA proposes to require the use of the radically different and enormously expensive GAO water treatment. Only recently have a few preliminary pilot plant studies of GAO treatment been undertaken. Results from these studies are either sketchy or not available. GAO is completely untested on full scale size for EPA's intended purpose. Thus, EPA is leapfrogging over a demonstration plant phase which could tell us whether the GAO proposal is feasible and effective. EPA's proposed use of GAO is not unlike placing wings onto a car and expecting it to fly. If such a device is to perform as an airplane, it would be prudent to build a demonstration model first and prove it before building a fleet of "air-cars" and having the passengers climb aboard for the initial run. Demonstration plants should be established around the nation to prove the efficacy, if any, of GAO. As we touched upon earlier, the health effects of GAO have not been researched at all. Dr. Joshua Lederberg, a Nobel Laureate and President of Rockefeller University, has warned: [Y]ou could make a horror story of the chemistry of what's in char- coal. . . . If you were to take charcoal and disaggregate it and hydrogenate it, you would end up with a lot of horror substances that we would really seriously like to avoid. EPA, itself, has acknowledged the need for "a thorough chemical and toxicologi- cal evaluation of the organic content of the effluent from fresh GAO beds." The National Drinking Water Advisory Council, established by Oongress to advise EPA, has similarly recommended that a health evaluation of the GAO treated effluent precede its implementation. EPA itself has expressed concern over the bacteriological hazard posed by GAO. Edwin Geidreich, chief of the microbiological treatment branch of the J~PA Water Supply Research Division specifically predicted that GAO: PAGENO="0170" 164 [W)ill modify the composition of the standard plate count population, increase the number of disinfectant resistant strains passing into the dis- tribution system and be the source of Increased endotoxins in finished water. Only after the complete lack of information regarding the adverse health effects posed by the GAO treatment was exposed, did EPA contract with the National Academy of Sciences to formulate a subcommittee on carbon adsorption to review these questions. That was after the GAO requirement was proposed. The NAS Subcommittee has not yet reported its findings. It also appears that EPA is ignoring or minimizing research and development programs that will aid in Implementing its broad authority to regulate the dis- charge of pollutants under the Federal Water Pollution Control Act. That Act re- quires EPA to develop comprehensive programs that will, where necessary, improve such waters for the withdrawals of public water supply. Although EPA continues "to support the national goal of zero discharge of pollutants," it has not participated in a comprebensive monitoring program for the purpose of de- termining what really Is in the water. EPA is proposing to reduce its drinking water monitoring programs drastically even before these preliminary studies are undertaken. Where toxic organics are found in drinking water, EPA should prevent their discharge into streams. Under the Federal Water Pollution Control Act and the Toxic Substances Control Act, EPA has the authority and direction by Congress to control much of the problem at the source. What limited research EPA has done, or is doing to support its proposed drink- ing water regulation appears to have given but a "passing nod" to its costs. The (Joalitlon, with its own funds, had to retain the engineering firm, Black & Veatch, of Kansas City, Missouri, to study the costs of the proposed regulations. EPiA's figures were totally without foundation. Black & Veatch estimated that national costs will be in the billions and water rate increases of 40 percent to 70 percent will be common. And that's at mid-1978 cost levels. Five months after proposing the regulation, EPA doubled its cost estimates. They are still woefully low. EPA estimated a GAO capital cost of approximately $82 million for the City of New Orleans. After severe criticism from that city's engineers, EPA hired am~ outside engineering firm to estimate `the New Orleans capital costs. That firm ~stimated the costs at $55.8 million. In `a joint statement, the American Society of Mechanical Engineers and the National Society of `Pro- fessional Engineers ("ASME/NSPE") observed, ". . . as engineers, we cringe at the very loose economic `guessing' which EPA has done here." EPA's Barbara Blum has characterized this regulation as among EPA's worst efforts `at assessing economic impact. Many cities will be required to make very large rate increases without any assutance whatever that GAO is necessary, will accomplish the intended results, `and will not be outmoded by the time It is installed and ready for use. How cities, already hard pressed for funds, will raise the vast sums required for these capital outlays, has not been researched by EPA, much less answered. GAO is also energy Intensive. EPA has conducted little or no research on this problem. The joint statement by ASME/N5PE states that the proposed regulation could require "10 million barrels of oil equivalent annually." Our tenuous energy situation, emphasized by the present crisis in Iran and OPEC's announced price increases, underscores the need to scrutinize any program as energy intensive as The abuses pointed out today do not reflect, we believe, malice on the part of EPA. Nor it is clear whether these abuses run throughout EPA's research and development program. Rather, they reflect knowledge of inadequate research and development programs that results from one experience in dealIng with EPA- the prqposed drinking water regulations. It is possible that these abuses reflect a conflict of purpose that exists In all of EPA's research and development pro- grams, and which finds its genesis in EPA's dual responsibility of administering the environmental laws and funding vast research and development programs. With this arrangement, EPA can direct research and development along whatever lines it wishes and thereby exercise control over the findings. In other words, EPA can direct research so as to support its position rather than basing its posi- tion upon the total and relevant scientific data available. An equally important concern is that such EPA control of research and development programs dis- courages knowledgeable persons from expressing their views for fear of possible loss of research funds. PAGENO="0171" 1.65 An answer might be to divorce EPA's research function from the EPA regula- tory and enforcement function, to assure that the former Is not used merely as a tool to support the latter. Most certainly, EPA needs to be urged to exert more research effort into the inflationary impact of what It is doing. Thank you for the opportunity of expressing these concerns. We hope that EPA has not closed Its mind to these concerns and that It will address the fail- ings of Its proposed regulation of organics in drinking water, especially as those deficiencies are centered around Inadequate research and development. The Coalition would be pleased to resopnd to any questions that the Subcom- mittee might have or to provide any information the Subcommittee might desire. Respectfully submitted. RAYMOND L. WILLIAMS, FosTER S. BUEBA, Co-chairman, Coalition for Bafe Drinicing Water. Mr. BU1U3A. On behalf of the Water Association, I would like to thank you for the opportunity to relate our concerns about regulation and research, since there will be many regulations subsequent to the currently proposed regulation to control organics. The association has long held that standards for drinking water quality must be established on sound, adequate information. However, it appears that the present EPA regulation is not a scientific approach to water quality and health effects concerns. As a result, we have regu- lation which reflects opinions and theories rather than sound con- clusions. After being heavily involved for the past year in the proposed regulation to control organics in drinking water, it seems to us that EPA is sometimes putting the cart before the horse. That is, research and development moneys are directed to support proposed regulation rather than serving as bases for regulation. Also, EPA appears to ignore or minimize certain research data and does not view results of studies in their entirety. Rather, it often selects those aspects which fit some preconceived hypothesis. An example is the assumption that chloroform at low dose levels is harm- ful. EPA has relied almost entirely upon a National Cancer Institute preliminary screening study of chloroform made to determine whether or not additional studies should be made. It was not intended to be used for extrapolating health effects of chloroform at low levels. A more definitive study is underway by the Stanford Research Institute, but the results are unknown as yet. How- ever, EPA proceeded with establishing a limit on trihalomethanes despite evidence from studies which refute the assumption that chloro- form at levels normally found in drinking water constitute a cancer risk. We believe these and other data should not be ignored until sound and sufficient health effects studies are performed. EPA has indicated the permitted level of trihalomethanes must be further reduced below the level currently proposed simply because trihalomethanes occur in drinking water and not because of any known or proven health risk. In proposing the drinking water regulations, EPA based the need on epidemiological data. Recently, the National Academy of Sciences' Subcommittee on Epidemiology reported that it was not possible to establish a link between the presence of trihalomethanes or synthetic organic chemicals normally found in drinking water and cancer in humans. EPA's response was that is really was not relying on epidemology studies after all. PAGENO="0172" 166 I would like to mention the recently released Tuthull-Moore epi- demiological study-the most relevant epidemiological study of chlo- rination and cancer mortality to date. This is an ecological time-lag study to assess the cancer mortality of Massachusetts communities exposed to chlorinated surface water sup- plies. Because it uses actual data rather than theoretical data, it is of great significance. The study concludes there is no evidence of statisti- cal association between cancer and chlorination of drinking water. These new data, among other things, reinforces our concern that adequate and proper data should be obtained prior to involving public water supplies in a "crash" program such as GAO contactors. To deal with synthetic organic chemicals, EPA is mandating na- tionally the use of an enormously expensive water treatment technique utilizing granulate activated carbon in a deep bed contactor. This is a shotgun approach to deal with a "may be" problem on the premise that it might do some good. There is no proof that the system will work for the purposes intended by EPA, and there is no assurance that it might not create more health problems than it wifl solve. In this regard, EPA is not even following its own recommendation made in 1975. That is, before going forward with GAO studies should be done to evaluate its effluent first. Unfortunately, such work has not been done even though the National Drinking Water Advisory Council likewise expressed this same concern to EPA last September. The National Academy of Sciences' Subcommittee on Absorption has not completed its studies regarding GAO efficiency and effective- ness. Yet, EPA is about to promulgate GAO in accordance with its proposal a year ago. Before proceeding with mandating GAO, there should be several full-scale demonstration GAO plants with attendant regeneration to determine the efficacy of GAC treatment. Also, there should be health-effects studies on the water both before and after GAO treatment to evaluate the health effects of regenerated GAO, whether positive or negative. EPA's proposed use of GAO-_for the intended purpose-is not dis- similar to that of placing wings onto a car and expecting it to fly. If such a device is to perform as an airplane, it. seems prudent to build a demonstration model first and prove it before building a fleet of "air-cars" and having the passengers climb abroad for the initial run. There should be a comprehensive monitoring program for the pur- pose of determining what really is in the water. This is fundamental in approaching the overall problem of organics. We believe that EPA should give greater emphasis to source con- trol which may be the best and. most equitable solution to the organics problem. EPA has such authority from Congress under the Water Pollution Control Act and the Toxic Substances Control Act. Yet, it has failed to effectively utilize the authority it already has in control- ling discharge. of organics ~t the source. We believe the overall approach to organics control is not scientific. It precludes innovation and flexibility to act in light of newly acquired data. The use of maximum contaminant levels is a far more scientific- ally sound and progressive procedure than the "shotgun" GAO treat- ment requirement of EPA. PAGENO="0173" 167 In stipulating GAO, EPA prevents treatment alternatives which may be more effective and less costly than GAO. EPA has not properly determined the economic impact of what it is proposing. We believe realistic economic considerations are important and should be a part; of research efforts. The Safe Drinking Water Act requires that costs be taken into consideration. The association deplores the lack of proper economic assessment of the organics regulation. EPA is proposing that the larger cities and water systems foot the multibiflion dollar cost of this nationwide ex- periment, oblivious to whether the costs justify the benefits, if any, as well as how these entities, already hard pressed for funds, will raise the vast sums requested. I would like to point out that Louisville will be required to spend an estimated $106 million and raise its raise 80 percent in order to comply with the regulations. We are not soliciting, nor do we wish, Federal subsidy in this mat- ter. But we do request that there be aecom~panying benefit as well as reasonableness and soundness in water quality matters. EPA should not dictate treatment techniq1ues. Rather, EPA should establish appropriate and meaningful maximum contaminant levels which are based upon sound scientific data and then let the individ- ual water supply implement the means of meeting the standard. CONCLUSIONS We are faced with the need to get good and proper answers con- cerning drinking water. We regret that basic health effects studies and water treatment research have been overlooked in the Nation's water quality program until fairly recently. But we are appreciative of recent increased funding of research in these areas. Any criticisms made today are intended to be constructive so that we may have ap- propriate and adequate programs for dealing with water quality. Drinking water quality and health effects considerations should be based on adequate research and sound scientific conclusions rather than fear of the unknown. EPA should make available to the public, on a timely basis, the results of their research and development programs. We must have comprehensive monitoring of water to determine what it contains. We must have proper health effects knowledge based upon reliable epidemiological and animal studies. Unfortunately, this aspect of health effects research has been sorely neglected so we have a lot of catching up to do. Since cancer is a disease of concern, we need a special effort in this field but we should not neo~lect other concerns. We reiterate that U.S. EPA should set stan~ards and goals for drinking water quality, but it should not dictate treatment techniques. There should be research on treatment techniques with appropriate demonstration plants. Specifically, there should be several demon- stration full scale. GAO plants, utilizing carbon regeneration, in order to determine the effectiveness and cost of GAO treatment. These units should be accompanied by health effects studies of water treated and not treated with GAO. PAGENO="0174" 168 We have tried to stay away from many of the regulatory specifics, but we will be glad to answer any questions you may have about the drinking water regulations or the preceding statements. Thank you, Mr. Chairman. Mr. AMBRO [presiding]. Thank you both, gentlemen. I would like to undeline the fact, of course, that these are not regulatory hearings. Mr. BURBA. I understand. Mr. AMBRO. It is proper, of course, in the context of what we are talking about here, to get into the research component that supports EPA regulations and that, indeed, is something that we are looking into in great depth. Just for the sake of argument, Mr. Burba, let us stipulate that there are certain industrial organics that have been proven to be carcino- genic if they exceed certain parts per million in the drinking water supply. With respect to your statement that EPA should set standards and goals for drinking water quality, not ~1ictate treatment technique; I noticed that you tempered that later on with the thought that EPA should, indeed, investigate and develop control technologies which might be available; but you are not suggesting at all here that local water districts throughout the United States have the financial or the professional resources to develop their own control technology; are you? Mr. BURBA. No, sir, and I selected a rather specific item of GAO. We think there should be research of several techniques. We are also concerned that there are no alternatives permitted, in my view, to GAO to deal with the organic problems but there should be the research, the basic research on the alternatives, for dealing with organics. We are opposed to U.S. EPA's mandating a specific treat- ment technique. However, any treatment technique that looks very promising, perhaps having some universal application, should be re- searched at a fufl plant scale size. This is what we are saying. Mr. AMBRO. I agree with that and it is my understanding that with respect to industrial organics, EPA has ongoing a number of pilot projects for their removal such as carbon filtration and aeration and others. I know that from sad experience, because I had a number of wells closed in a city in my district because of the promulgation of standards with respect to industrial organics, and EPA told us that there were a number of pilot programs throughout the country to determine the most effective method for their removal. With respect to the kinds of things that come up before this sub~ committee in its review of the Office of Research and Developn~nt budget in EPA, perhaps you could deal with the question of increased moneys for health effects research, diminished moneys for control technology or tell us in more practical terms why a 100-mile long county serving 1 million people is unique. Are you questioning the cost of removing carcinogens from water supplies? Mr. FLYNN. No. I am not questioning the fact that if money has to be spent to remove carcinogens from the water supply it should be spent. I am saying in our case it does not have to be spent and that is just one thing. PAGENO="0175" 169 The second thing I am saying is that more money should be spent on. research for the prevention of these contaminants, to prevent them from getting into the water supply and second, to research the study of their removal so that wells which are now closed because they meet this standard of 50 parts per million or 100 parts per million can be put back in service. Let me explain. Our county which you know is 90 miles long with Montauk Point at one end and the town of Babylon at the other end. We have an integrated water system and that is our problem insofar as these regulations are concerned since we have some 440 wells in opera- tion and we have 150 well fields. Therefore, we have 150 points of entry into an integrated system so we are not like somebody on a river and I do not want to put Mr. Burba in the box here because he is on the Ohio River, but we are on 150 rivers. We are getting water into an integrated system from 150 different places so we have to put in 150 separate filtration systems under these regulations. What I am saying is if a well in the village in an industrialized area becomes contaminated and if we find these organics, we shut the well and that area is serviced by a well from an area not containing these organics. Mr. AMBR0. Maybe Mr. Guerrera can help us. Are you suggesting that in an integrated system, if one finds 50 parts per million of tn- chloroethylene in one portion of your system, that the same count does not exist in another portion, so you can utilize it? Mr. FLYNN. That is correct. We are saying that the fact that we might have trichloroethylene in a well in Babylon does not mean our well 90 miles away in Montauk is contaminated, or our wells in Hunt- ington. We can find some of these contaminants as they were found at Grumman in Bethpage as you know and that caused a lot of hys~ teria 2 or 3, or 4 miles away, where we have wells delivering absolutely organic free water. So, we can solve our problem wherever we do find organics by simply shutting the well contaminated at the moment. But, we would like to find out and what we would like research done in once we shut that one well is how to get it back into our system some day. We have actually done that. We have had a well we have closed and through flushing techniques and other ways we have found that what- ever caused the initial reading in the analysis disappeared and the health department has allowed us to put the well back into our sys- tem. But since we have 440 wells and 150 well sites, we can balance the problem. We can eliminate the problem by simply shutting a well. Mr. AMBRO. What you are saying then is that if you find that one of your well sites contains too many parts per million of industrial or- ganics, then all 440 wells should not be affected. Mr. FLYNN. Even other wells at the same location may not be affected. Mr. AMBRO. Do you find that flexibility with EPA or with your State health department? Mr. FLYNN. Our concern is under this regulation and that gives us great concern. The statement in the regulation says in the absence of any significant information a variance can be granted. Well, we will bankrupt our community because some organic con- taminant found in one town we will have to put in this system say in the town of Huntington. PAGENO="0176" 170 Mr. AMBRO. So, you have a large water district with a number of wells and with water being retrieved from the aquifers, and Mr. Burba represents a water supply retrieved from a river. We have no one here from a small water district. Mr. GUERRERA. The small district, water district within our own dis- trict had a problem and was an unusual situation in that it did not vio- late the total trihalomethanes regulation and it would not be required to install GAO because it serves less than `15,000 people yet they had an industrial degreaser that the State of New York in an extrapolation of data on trihalomethanes established a 50 parts per million number and that was originally enforced upon that little district. Even without any regulations or without any standards the mere presence of a small amount of that material without any evidence of epiderniological effect caused that water utility to be in the trouble it was. Mr. AMBRO. I will just comment that that is precisely the problem, because New York State standards are more stringent than EPA, and that is going to give all municipal water managers the fits if we do not have greater research in remedial treatment techniques. Mr. Walker? Mr. WALKER. Thank you, Mr. Chairman. We were just commenting here a minute ago on the fact that public visibility of issues sometimes results in regulatory authority and then you all can find yourselves in difficulty. The only point I have is to make one comment and that is, that it seems to me, that what you are saying to us is something we have heard with regard to the EPA before, and that was when EPA got into the whole business of sewage treatment and locked communities into mechanical treatment processes for their sewage treatment, and the regulations flowed from that, but then, even when it was shown that smaller communities might be able to use another kind of sewage treatment, it became almost impossible to fit that into the process. Engineers, regulators and everybody else was geared up for one par- ticular kind of process. Now the EPA is backing away from that and saying that there are other acceptable processes that can be used in this treatment, but we are still finding, the problem of getting the idea accepted within the whole mechanical treatment community. I get the feeling you are saying that we all are going in the same direction, but locking everybody into one program, when in the end, we all want clean water. Mr. BURBA. Yes. Mr. WALKEL And that locks you into essentially one control technology. Mr. Bt~BA. Yes; without any demonstration it will work outside the laboratory and this is what concerns us. This is why if we do get locked into one process, and we are certainly against that, let us see a demonstration plant somewhere that works. Mr. WALKER. Let us have some research to back up the regulations. Mr. BURBA. Yes; I think if we do what we would like to see done which is go the MCL route and let us select the technology, we would urge the research ai~d the proof, the demonstration of treatment alter- PAGENO="0177" 171 natives. Then let us select the alternative that we think would suit our yartieular situation and do the job that we should. Mr. WALKER. Thank you, Mr. Chairman. Mr. AMBRO. Mr. Lundine? Mr. LtTNDINE. Just to follow up on that point, Mr. Burba, do you know of other technologies which should be examined and possibly demonstrated to achieve the same results? Mr. BURBA. This same result is what is frustrating. This is due to EPA's effort to remove something you cannot identify or quantify but which if they exist, may be harmful. How do you develop something that is equal to that first? Second, two of the three operating criteria for the proposed GAO system involved total organic carbon which appears to be completely unrelated to any health effects. If you remove harmless carbon, what have you accomplished? But you would have to do it with any other system. There are far more effective and efficient methods of removing specific compounds of con- cern but they do not remove the total organics and would not meet EPA's proposed requirement for GAO. Yet, such a system would be far more effective and efficient in removing specific contaminants than would GAO. For example, reticular synthetic organics might do a good job of removing certain synthetic compounds, but not total organ- ics. A particular carbon might be efficient in removing chloroform but not total organics. Aeration, for example, might be all right for carbon tet or other volatile organics. I think you might accomplish prevention through treatment chemistry. One thing we are looking at is a shallow well system, but again, this could not conform to EPA's operating criteria by which it might measure what is to be accomplished by GAO. What I am saying is we are locked in and frustrated with EPA's fixation for GAO as the only treatment technique. The thing that concerns me is that a GAO plant will be financed with 40-year bonds. By the time we get it built it may not operate, or there may be a better technology. What do we do with that system for which we have to pay for 40 years? We cannot walk away from it and the financial obligation. Mr. LtTNDINE. One thing that concerns me, too, is that there are a whole lot of smaller water systems in this country that do not begin to have the technical competence represented here at this table. As the analogy was made, I think, by the chairman, these smaller water systems may be in the same situation here as they were with regard to sewage treatment, in that what makes sense for a certain scale may not at another scale, and I am concerned about locking in on a single technology for a number of reasons, but among them is the fact that we may be able to develop relatively more efficient systems to meet a particular need. Mr. BURBA. Let me respond, sir. The regulations for organics remov- al really apply to systems serving over 75,000 persons. Those below have to do some monitoring, but they really do not have to get involved in the treatment requirement under the proposed EPA regulation. 43~778 0 - 79 . 12 PAGENO="0178" 172 Mr. LUNDINE. I understand that, but still there can be a vast differ- ence between systems. Mr. BURBA. Yes. Mr. LUNDINE. I have no further questions. Mr. AMBRO. Thank you. You know I have often thought of this whole process of hearings as being rather stilted, because in the first instance, we have the agencies come in and make their justification for line items in their budgets and then we have public witnesses come in and criticize a variety of line items or parts of the budget, and we kind of act as a sounding board or conduit to take your arguments and bring them back to the agency which, because of the time constraints, are not able to respond in depth. That is one problem. Then we have the problem that each of you raise, that of Federal and State regula- tions impacting on local water districts and the requirement on the part of the local municipal managers to raise the money to take correc- tive action. That money is usually generated on a regressive tax base. We have the problem of internal interface among agencies and a lack of coordination or duplication among them, and we have Dr. Pitts suggesting that we may, indeed, benefit from a dual approach, so we can see a variety of problems/solutions coming from a number of groups, and you get an idea of the complexity and the size of this whole interrelated tangle that we have here. I am not suggesting by virtue of this monolo~ that we confine our- selves to the specific areas that we are dealing with in this budget, but I would like to zero in, if I could, on just a couple of things. With respect to, again, this whole business of not wanting EPA to mandate a solution, I am not sufficienfly knowledgeable2 to tell you the truth, that they have the ability legally to mandate specific technology. Do you know, Mr. Flynn? Mr. FLYNN. Part of Public Law 95-2~3. Mr. `AMBRO. They can say, remove the organics and we want you to use a certain treatment? Mr. PENDYGRAFT. Mr. Chairman, we specifically think they do not have the authority to impose the treatment technique under the Safe Drinking Water Act. As we read the act, it requires EPA to impose maximum contaminant levels unless the specific contaminant cannot be monitored feasibly which means it cannot be monitored tech- nologically or is not economically feasible to monitor. From witnesses at the various hearings we have presented testi- mony that we think the compounds they express concerns about can be monitored. Consequently, we think they do not have the legal authority to impose the treatment technique. Mr. AMBRO. Let us assume that you are correct. I have been long concerned even as a member of this subcommittee, but before that, as one who was required to raise the money to meet certain standards and regulations, with the notion that, as I said earlier, at the level at which we are required to raise the money to take remedial action we do not have the resources, either in funding or professionals to do it, and that in-house, in those agencies at the Federal level, especially those agencies that develop control technology, that we do not have the kind of balance between the identification of contaminants and pollutants PAGENO="0179" 173 on the onehand, and the ability economically through modular units, to say to each of you here are a variety of choices forcontrolling them. Now, I recognize as do you, that EPA has limited responsibility for determining the economic impact of the identification and regulation of contaminants. That is clear, but in terms of the control technology for which we provide money at the Federal level, I am concerned about the ever-widening gap between increasing identification of con- taminants, on the one hand, and the inability, without economic dev- astat1ion, of your ability of implement treatment techniques at the local level, on the other hand. In that kind of a recitation one immediately says, or characterizes that kind of discourse, as being the end of all in terms of economics vis-a-vis environmental safeguards, and I do not want to sound that way because I am very protective of EPA's function, but maybe you would like to say a word about this business so we can have a record which is rounded out in this regard. Mr. FLYNN. Simply as I said before, Mr. Chairman, I think that they have tried to throw this blanket over too many people in too many different situations and because as I have demonstrated and we can demonstrate that we do not need this system that they are proposing in Suffolk County and the Suffolk County Water Authority can meet these goals and deliver pure water without spending all of this money. We feel that we should be given the opportunity by EPA. to de- monstrate that and having demonstrated it, to be left alone except to do regular monitoring to demonstrate regularly that we are deliver- ing purewater. Mr. AMBRO. Well, you have said that, and I say to you that that is not the specific function of this subcommittee, and if you could be more general, in terms of your comments, as we are dealing with the whole Nation. I will tell EPA as one of your representatives to . leave Suffolk County alone. Mr. FLYNN. What I am saying is they simply have not done enough research into the problems facing suppliers who get their raw water from ground water supplies. In other words, they should be doing research, for example, in that one section where they say variances can be given in the Great Lakes or a protected watershed or you get your water from deep ground water except they then say in the absence of significant information that there are contaminants. All I am saying is they simply have not done enough homework in the field which directly affects us. Mr. AMBRO. That is directly related to the B. & D. component of our jurisdiction. Mr. BtTRBA. A real basic deficiency is the lack of research on health effects. We are acting presumptiously, that is, EPA is. It is acting before it gets the proper data. We have to have good data because otherwise, we are operating like a baseball game with a blind umpire. Mr. AMBRO. There is an increase in the health effects research fund- ing in this budget. Whether or not the administrative or management group will, indeed, attack the problem successfully is quite another thought, PAGENO="0180" 174 If money can be considered as one ingredient in targeting that prob- lem, there is, as I say, a recommendation for a healthy increase in health effects R. & D. Mr. BURBA. But then they have to look at the results and come. up with a good decision based upon the facts that are obtained rather than looking for information that will support their previously taken position. Mr. AMBRO. Gentlemen, I could talk to you at length about this, but I must get on with these hearings because we do have two very dis- tinguished people who have been sitting here patiently, as Dr. John- son is now here, and I would like to get to them. Before I do that, I would like to thank Mr. Flynn for coming up and giving us the benefit of his wisdom. Our last panel will report to us on a study performed in response to the fiscal year 1978 Research Authorization Act. That act called for .a study of EPA's health effects research program by the Science Advisory Board. Dr. Whittenberger was chairman of the panel mak- ing the study and Dr. Johnson was a member of the panel. We are particularly interested in their testimony today as it reintes to the issue identified previously. That is, it seems to be easier to iden- tify potential health threats than to do something about them. The problem of course is the word "potential." We need to know very certainly whether or nOt `a contaminant will have health effects at a certain level of exposure. We need vigorous accountable research, to find out if expensive control methods are justified. These two gentlemen-both distinguished health scientists-will provide us with a useful record in this regard. STATEMENTS OP A PANEL PROM THE SCIENCE ADVISORY BOAED'S HEALTH EFFECTS RESEARCH REVIEW GROUP, CONSIST. ING OF DR. NAMES L. WHITTENBERGER, PROFESSOR OP PHYSIOL.. OGY, SCHOOL OF PUBLIC HEALTH, HARVARD UNIVERSITY, AND DR. flJLIUS E. J~OHNSON,. CONSULTANT (FORMERLY VICE PRESI- DENT FOR RESEARCH AND DEVELOPMENT), DOW CHEMICAL CO., MIDLAND, MICH. Dr. WHIITE*BEROE.R. Thank you very much, Mr. Ambro. I under- stand our time is very short. Mr. AMBRO. We have no time problem now. Dr. WHITTENBERGER. I will dispense with most of the first page of my statement and start near the bottom and indicate that the Congress has repeatedly expressed concern about EPA's research and develop- ment activities since the Agency was established. One expression of this concern was the extensive study by the National Academy of Sciences-National Research Council, which led to a series of reports in 1977. We found the Academy study very helpful in our examination of EPA health effects research. In April 1978, the Science Advisory Board established a health effects research review group, under my chairmanship, with Dr. Roger" McClellan as cochairman, to carry out the mandate of the authoriza- tion act. PAGENO="0181" 17ö [The report from the health effects research review group is included as appendix 4.] Dr. WHITTENBEaGER. Our first step was to meet Congressmen Brown, Wirth, and members of this subcommittee staff, and with staff of the Senate Committee on Environment and Public Works, to determine as clearly as possible the objectives of the study. The review group was chosen to represent the major disciplines and specialties in environmental health and management of environmental health research. We supplemented the core group as needed for special tasks. We met as a group or in subgroups at EPA headquarters and at all of the laboratories where health effects research is conducted. We are aware that only a small part of the health effects research relevant to environmental protection and regulation is done by EPA, but we considered it impractical to do anything beyond a cursory sur- vey of work outside EPA in the time available to us. In the last study, Mr. Chairman, only about 12 percent was funded by EPA. The greater part of the research was done by the National Institutes of Health. That is of particular interest in connection with some of the subjects that have been considered earlier this afternoon; that is, the relevance of the research that EPA does to the setting of standards. The fact that EPA does so little of the environmental health re- search makes it all the more important that that research be relevant to the mission of EPA. The principal guide to our discusions with EPA staff-and we did talk to individuals at all levels of the Agency, from Mr. Costle down to bench scientists-was a checklist prepared by Dr. Julius Johnson and accepted by the group. The checklist is included in the report and is designed to test the two main attributes of sound research in a regulatory agency-the responsiveness of the research to the regulatory program needs, and the quality of research, which is so important if regulation is to be defensible. The report [appendix 4] is only now available, so I know you have not had an opportunity to study it. I shall summarize briefly some of the highlights and will be glad to answer questions now or at a later date when you have had time to study the report. As you gentlemen know, there are very special problems of health effects. research in the regulatory agency. The research has to be re- sponsive to the needs of regulation which are determined by legislation. The implementation of the law is in the hands of program offices~ of EPA, which means the program office is the driving force in the identification of research needs, the planning of research, the alloca- tion of resources, et cetera. It is exceedingly important that there be a close partnership between the program offices and the Office of Research and Development which, since the agency was first established, was supposed to be the branch which conducted the research in support of regulation. We observed, as others have before us, that EPA does not have a good record for responsiveness. That is known to the Assistant Ad- PAGENO="0182" 176 niinistrator of ORD and to senior staff. We did not tell them anything they did not already know. We do think that conditions have improved substantially in the past year or two and this is attributable to the establishment of the pilot research committees. These have established communication that did not exist before and they have helped to set common goals and priorities and plans. They are an important step in the right direc- tion. We do not think they are adequate as the answer to the long- term needs for much better coordination between ORD and the program offices. There needs to be a mechanism that can be institution- alized. An important point that came up repeatedly in our discussions was the need for this kind of coordination. Dr. Pitts, I thought, gave an excellent example of this need in his testimony earlier in connection with the development of a standard for photochemical oxidant. Numerous examples could be given of the absence of the long-term kind of research that answers questions that come up inevitably in the development of regulations. Our report cails attention to a number of problems in the allocation of resources, both personnel and funds. We repeatedly found prob- lems relating to the allocation of funds without any increase in posi- tions, large fluctuations from 1 year to another, and changes within the year that were substantially disturbing to the research effort. The implicatio~is are fairly evident. We saw marked variation in the quality of extramural grants and contracts and how they are a~Jministered. The variability in morale and enthusiasm and sense of mission from one part of the agency to another is also very striking. One of the important criteria of quality is the method of reportin research results. The results must not only be timely and relevant an properly inthrpreted to the program offices, but must have the quality and integrity that will stand up in court when a regulation is chal- lenged, which seems to be almost routine these days. The importance attached to publication in peer reviewed journals varies substantially from one part of the agency to another and there was quite a good correlation between the emphasis placed upon that and the level of morale and the sense of mission among the scientists. When we had virtual.ly completed our study we thought it would be interesting to look anew at the 1977 report of the Academy on R. & P. in the EPA; a section of our report quotes the Academy rec- ommendations and identifies our observations as they compare with those made by the Academy. We found that many of the recommenda- tions in the Academy document still have not been implemented and in our view, should be. Referring once again to Dr. Pitts' testimony about EPA I had the feeling several times that he was talking about EPA and its research and research management as if he had been a member of our study group. I will be happy to answer any questions. Mr. AMBRO. Without objection, I would like to insert your entire statement in the record along with your opening remarks. [The full prepared statement of Dr. Whittenberger follows:] PAGENO="0183" 177 STATEMENT OF JAMES L. WHITTENBERGEB, M.D., BEFORE THE SIJBCOMMITTEE ON THE ~INVIR0NMENT AND THE ATMOSPHERE OF THE COMMITTEE ON SCIENCE AND TECHNOLOGY, U.S. HOIJSE OF REPRESENTATIVES I am James L. Whittenberger, Professor and Head of the Department of Physi~ ology and James Stevens Simmons Professor of Public Health at the Harvard University School of Public Health. I am also Director of the Kresge Center for Environmental Health, which focuses an extensive program of research, research training and teaching on problems of environmental and occupational health. I~iy responsibilities in research are primarily research management of programs in epidemiologic and toxicologic studies. Since 1956 I have served the Federal Government in a number of advisory roles, particularly on health effects of air pollution, but including a variety of other health problems as well. Since 1969 I. served as co-chairman with Dr. Norton Nelson on two Task Forces of the National Institute of Environmental Health Sciences to define Research Needs in Environmental Health and was a member of the President's Science Advisory Committee Panel that prepared the report, Chemicals and Health, published in 1973. I have reviewed two research programs at EPA's request, the Community Studies program of the Office of Pesticides Pro- grams and the Community Health and Environmental Surveillance System pro- gram of the Office of Research and Development. As a member of the Executive Committee of the Science Advisory Board of EPA since its establishment, I've participated in several projects including a study of the sulfate problem and chairmanship of the review committees for the Criteria Documents on Photo- chemical Oxidants and short-term exposures to Nitrogen Dioxides. The study under discussion today was requested in the Authorization Act for the 1978 R. `& D. budget of EPA. The Congress has repeatedly expressed concern about EPA's Research and Development activities since the Agency was estab- lished. One expression of this concern was the extensive study by the National Academy of Sciences--National Research Council, which led to a series of reports In 1977. We found the Academy study very helpful in our examination of EPA health effects research. In April 1978 the Science Advisory Board established a Health Effects Research Review Group, under my Chairmanship, with Dr. Roger McClellan as Co-chair- man, to carry out the mandate of the Authorization Act. Our first step was to meet Congj~essman Brown, Congressman Worth and members of this Subcommittee stalY, amJ~ with staff of the Senate Committee on Environment and Public Works, to determine as clearly as possible the objectives of the study. The Review Group was chosen to represent the major disciplines and specialties In environmental health and management of environmental health research. We supplemented the core group as needed for special tasks. We met as a group or In subgrOups at EPA headquarters and at all of the laboratories where health effects research is conducted. We are aware that only a small part of the health effects research relevant to envirOnmental protection and regulation Is done by EPA, a~ little as one-eighth according to the latest survey, but we considered it lmpract~*J~ to do anything beyond a cursory survey of work outside EPA in the timeavailaMe to us. The principal guide to our discussions with EPA staff at all levels from Assist- ant Administrators to bench scientists was a check list prepared by Dr. Julius Johnson and accepted by the group. The check list Is included in the report and Is designed to test the two main attributes of sound research In a regulatory agency-the responsiveness of the research to the regulatory program needs, and the quality of research, which Is so important If regulation is to be defensible. The report is only now available, so I know you have not had an opportunity to study It. I shall summarize briefly some of the highlights and will be glad to answer questions now or at a lt~ter date when you've had time to study the report. It's important to note the special problems of health effects research in a regu- latory agency. By definition the research must be relevant to regulation, which in turn is defined by a dozen or So acts of Congress. Implementation of the legIsla~ tion involves the Program~Offices (for example, Office of Air, Noise and Radiation, Office of Water and Waste Management, Office of Toxic Substances.) The Program Office Is then the driving force in terms of a regulatory calendar that has to be met. In Identifying research needs, planning a research program. allocating resources; obtaining results and Interpreting results for regulatory PAGENO="0184" 178 purposes, It is essential that a close partnership exist between the Program Office and O.R. & D. If ORD is not responsive, in terms of timeliness, relevance and quality, the Program Office will look elsewhere for its H. & D. needs. In the past O.R. & D. has not had a good record for responsiveness. Some of the Program Offices have conducted their own research. It is our observation that the situation has improved substantially under Stephen Gage's leadership. The pilot research committees have established communication that is essential to establishing common goals, priorities and plans. Further evolution Is necessary however to institutionize, In a less cumbersome way, the linkages between pro- gram offices and O.R. & D., the latter to include laboratory directors and senior ectentists as well as headquarters personnel. We believe that such coordination of research planning would identify long- term research needs as well as the short-term needs tied to specific regulations. Some examples are given in the report. We also identified problems in the allocation of resources~ personnel and funds. In some Instances the problem arises from allocation of funds without increase of positions, or from large fluctuations in budget from one year to another. Some implications of this situation are compromises in quality of extramural grants and contracts, and interference with desirable development of scientific careers. Improvement in these areas is essential if EPA is to attract and retain scientists of high quality, working with a sense of mission and high morale. We found such conditions in some laboratories but not in others. One of the important criteria of quality is the method of reporting research results. These results must not only be timely, relevant, and properly interpreted, but must have the quality and integrity that will stand up In court when a regula- tion is challenged. Many of the scienists we talked to recognized the value of having their research published in peer-reviewed journals. We strongly endorse this perception and recommend that the policy of peer-reviewed research be more widely stressed throughout the agency. We also make other recommendations in the report about quality assurance and accountabiltty. Near the end of our study we reviewed the Academy recommendations about research and development, to see whether our perceptions differed, and to deter- mine the extent to which the recommendations have been implemented. Although some have been implemented, we found that by and large we could restate most of the Academy recommendations as still relevant and appropriate. Mr. AMBRO. I would like to ask Dr. Johnson if he would like to say anything at the outset. Di:. JOHNSON. I believe I should respond to your questions. Mr. AMBRO. Well, you came all .this.way. Dr. JOHNSON. I have one question. Do you, as the new Chairman, have jurisdiction over fog in the Midwest? Mr. AMBRO. Let me start by performing a task that I said I would for Mr~ Watkins who left a number of questions here, and I suppose they are geared to elicit certain kinds of responses, but I told him I would ask these questions and I shall. First, is it true your Science Advisory Board subcommittee reviewed the criteria document three times and rejected it three times? Dr. WHITrENBERGER. I will qualify that by saying we re)ected two successive drafts of the criteria document for photochemical oxidants. We were not entirely satisfied with the third draft that was presented to us, but when we asked for additional rewriting, we were told there was no tune for that to be done. We just could not accept it. I do not know whether I should say we rejected it three times in the sense he is implying. Mr. AMBRO. Let us run through these and maybe develop a pattern. Last June, EPA issued its final criteria document associated with the proposed standard for photochemical oxidants. Did the EPA submit the final criteria document and the proposed standard for review by your subcommittee? Dr. WHITTENBERGER. No. PAGENO="0185" 179 Mr. AMBRO. EPA's proposed standard relied primarily on t~te Adams' study. Did you advise EPA that the proposed standard shou~!=1 be based primarily on that study? Dr. WHITTBNBERGER. No; I feel about that study as I do some of the others, that there are significant qualifications that should be made to the interpretation of the study. It is not very strong evidence on which to base a standard. Mr. AMBRO. Did you ever accept the criteria document? Dr. WHITTENBERGER. Not as such. Mr~ AMBRO. EPA's final standard issued in January relies heavily on the. Durham study which was a project conducted by undergraduate students at Stanford. Did EPA rely heavily on the Durham study in setting the standard? Did you review that study? Dr. WHITTENBERGER. I would like to comment that since the meeting in February at which we asked for revisions of the document and were told that was not possible, I have not reviewed the individual studies that EPA. is depending on for its present recommendation. I have specifically not reviewed the Durham study and cannot com- ment specifically on it. Mr. AMBRO. Let me hasten to say Doctor Johnson, that any time you would like to comment on any of this, please feel free to do so. In January 1978 EPA held a meeting to announce it would base the revised standard partly on the conclusion of an advisory panel led by Dr.. Carl Shy and partly on a novel risk assessment method being de- veloped by the agency. Was your subcommittee asked to review the conclusions of the Shy panel or this new risk assessment method? Dr. WHITTENBERGER. The subcommittee was not. The Science Advisory Board was asked to review the risk assessment method but has not done so yet. [A summary statement from the EPA Advisory Panel is included as appendix 5.] Mr. AMBRO. Mr. Watkins says that obvIously an issue~of crucial im- portance is the lowest ozone level at which human effects have been demonstrated. During your subcommittee's deliberations, Dr. James MCCarroll repeatedly noted that no human effects have been demonstrated at ozone exposure below 0.25 part per million. During the meeting of February 1978 EPA was asked if effects had been observed below 0.24 part per million. However, in issuing its final standard last month EPA said that at levels in the range of 0.15 to 0.25 part per million, adverse health effects will be experienced by significant numbers of sensitive persons. Do you think EPA has followed your subcommittee's advice? Dr. WHITTENBERGER. I think typically they have used a wide enough range that what they say is correct, but I do not think there is much basis for the lower margin for that interval. Mr. AMBRO. Let me interrupt this and say if it smacks of an inquisi- tion, I do not want it to, and if you pefer, I will just mail you these questions and you can respond or you can do precisely what you are doing IIQW. PAGENO="0186" 180 Do you want to finish this'? Dr. WHITTENEERGER. I am perfectly willing either way. Mr. AMBRO. Then let us run through them. In March 1978 members of your subcommittee voted on the adequacy of the revised criteria document. You voted to reject the document saying, "The health risk assess- ments are largely speculative, incomplete and heavily dependent on speculative treatment." Do you have any examples of speculative treatment of health evidence? Dr. WHITTENBERGER. There were many examples in the criteria docu- ments, especially in the first draft. The improvement of the health effects portion of the later drafts in general was a toning down of the speculation they were making. They did not completely eliminate it. I do not mind their speculating so long as it is labeled as such. Mr. AMBRO. An important issue in setting the standard is what should be considered an adverse health effect. Dr. Robert Frank also warned EPA about the need to define a health effect. However, in issuing its revised standard, EPA has taken the position that any effects including only symptomatic responses are adverse health effects. Do you feel the criteria document adequately defined adverse health effects or do you feel EPA has followed the subcommittee's advice in setting the standard? Dr. WHITTENBERGER. I think that one of the weak parts of the cri- teria document is the inadequate attempt to define adverse health effects. Mr. AMBRO. At a meeting of the Science Advisory Board Executive Committee on March 3, 1978, you said that the standard setting part of this process got uncoupled from the criteria document part. The last question is what did you mean by that? Dr. WHITTENBERGEB. During the period in which members of the Office of R. & P. were preparing the second draft of the criteria docu- ment I learned, that there was a public meeting scheduled for a date in January by the Office of Strategy and Standards, Mr. Pagett's office,. at which a new photochemical oxidant or ozone standard was to be considered. I was very puzzled because the Science Advisory Board was in the process of looking at the criteria document which was supposed to be found acceptable as the scientific basis for the standard before a stand- ard was promulgated. On inquiry I found that the scientific basis for the January meeting was the report [see app. 5] of a panel under Dr. Carl Shy's chairman- ship which was the result of a contract of EPA with the University of North Carolina. That activity was independent of the Science Ad- visory Board and represented an activity of the program office. I saw that as an uncoupling of the ORD Science Board role and the stand- ard-setting process itself. Mr. AMBRO. What is a good health effects research laboratory? Can you tell us in your opinion, what is a quality health effects research laboratory at EPA? Dr. WHrFTENBERGER. There were high quality areas in all of the laboratories I visited, Research Triangle Park, Gulf Breeze? Cincin- PAGENO="0187" 181 nati, and others. I did not visit Duluth but I know Duluth is of high quality. Mr. AMBRO. Then the quality of the health effects research laboratory is not a particular problem here, is it? Dr. WHITTENBERUER. In some parts of the agency I think it is. Mr. AMBRO. Is there any way that we can develop those ingredients which, on the one hand, make for a quality health effects research lab- oratory and try to extend that to the other laboratories? Is there some way that we can define those ingredients that make a cpiality laboratory. Dr. WHITrI~INBERGER. That is a question that has concerned, me very much. We felt that there were characteristics of some of the better units in EPA and in general, they were the units which had a very clear sense of mission. They did work very effectively both with. the Washington office of ORD and also with the program office, They tended to have better contacts with the scientific community outside of EPA than other units, They included personnel from universities working in the lab; all of the criteria were present for a very good scientific climate. I perhaps should give you an example of the oJ?posite. One of the unique resources of EPA is the human studies inhalation chamber facility on the campus of North Carolina at Chapel Hill. The agency is completely unequipped to use that facility for the kind of research that is very important in regulation. If you look for studies that were relevant to setting of the ozone standard you find that they did studies at 0.6 ppm instead of 0.1 or 0.2 and 0.6 is ir- relevant to standard setting. [The following question and answer were submitted for the record:] Que8tion. How much of the research that formed the basis for the revised oxidant standard was conducted by the EPA? How many major studies have been conducted since the original standard was promulgated? How many of these were conducted or supported by the EPA. Answer. I do not have ready access to the detailed information which is neces- sary for an exact answer. I shall give opinions based upon my own knowledge and suggest that a quantitative answer about EPA support might be sought from the EPA, Office of Research and Development. I also have to restrict my answer to health effects research, since I'm not an expert on the atmospheric chemistry, modelling, or other research which formed the basis for the revised oxidant standard. I also limit my attention to the studies which seem most relevant to standard setting. It is my impression that EPA support play a major role In laboratory studies of ozone but a very minor role In controlled human exposeure research and epi- demiologic studies. In answer to the part of the question about "major studies" conducted since 1970, I find it difficult to classify research that way, preferring to think in terms of a series of publications from a particular individual, group, or labora- tory. One such important series of papers has come from Bates and his co-workers. Most of this research was almost certainly supported by the Canadian government, although one of Dr. Bates' associates is now at EPA on an IPA arrangement. Dr. Hackney and his group are another source of important papers on controlled human exposures to ozone; I believe this work was supported largely by the California Air Resources Board and NIH, with a small amount from EPA. I think the same comments would apply to Dr. Horvath's group, although I'm less sure of their sources of support. I know that DOT and the Air Force supported Dr. Lucia's research but I don't know if EPA contributed. EPA. supported Dr. Kerr at the University of Maryland but I don't believe this would be considered a major study. PAGENO="0188" 182 In laboratory studies of ozone there have been important series of publications by Drs. Goldstein (B.D.), Menzel, Ehrlieh, Gardner and Coffin. Bartlett also did an important study on newborn mice. I do not know how much of the support for this work came from EPA, except that Coffin and Gardner are EPA em- ployees and both have aggressively attempted to involve university scientists in ozone research. My overall impression is that EPA has supported only a small fraction of the national research effort on the health effects of ozone, but that the fraction may be somewhat higher for ozone than for all environmental health research (EPA's share was about 12 percent in the most recent survey I've seen, based on a 1978 report). A very important study in relation to setting a short-term standard for nitrogen dioxide is a study that was reported 3 years ago, a study -conducted at a university in France. EPA has not gotten around to planning a duplication of that crucial study. Something needs to be done about that laboratory. Mr. AMBRO. Can you suggest some reasons why that laboratory is unequipped and others might be? Is is money? Dr. WHITrENBEaGER, Frequent changes of leadership I think is the main reason. Mr. AMBRO. Maybe Dr. Johnson can contribute something here. Dr. JoHNsoN. In the conduct of this study, as indicated in the re- ports, we concluded as a committee, that the relationship of research to the regulatory mission of the agency was prime. It was not research for the sake of research, but research for information to support the regulation recognizing that certain long-term research may be neces- sary in order to support long-term regulatory needs. Therefore, in t.ryin~ to aproach this task as indicated by Dr. Whit- tenberger in the outline, we tried to identify the mission as a very important aspect-. The elements are described in the report so I will not repeat them. Also, the quality was examined with a very strong feeling that quality is represented by the scientific integrity of the people. doing the work; the scientific integrity of the papers and reports being published as determined by peer review, and, the ultimate test is the quality of defensibility in a court of law where these matters are challenged. I might add, I think, it is in the interest of the Agency, the interest of the Academy of Science, and interest of the regulated industries to try to have scientific quality, the common ground on which these issues can be decided. In looking at this study we were interested in the cross coupling between what was going on in the laboratories and what was desired by the program office. Early in the studies we interviewed the Various program leadership to ask: "What do you expect from research; what are your needs; what are your data gaps for the future?" This helped us to get a feel for how they regarded research; to try to get a feel for whether pro- gram office leadership looked at research as a supporting element or as something on the side brought in when convenient. I would say, to answer your question, that good results came from those laboratories which were closely coupled, where there was a good understanding by people at lower levels in the laboratory and their counterparts in the program offices w&rking on regulations as to what their objectives, goals, and plans were. Where objectives, goals and PAGENO="0189" 183 plans were well understood you found a better spirit in the organization. I think the drinking water program was a case in point; inhalation toxicology at Research Triangle Park was another example where there was close coupling and understanding. The research people themselves were excited. They did not feel put upon by requests from outside. They were excited because it related to the Agency's mission and the Agency's mission became their mission. The leadership of Steve Gage has made some progress with pilot research committees. [Progress reports, see app. 1 and 2.] He has five. Some have done better than others. Mr. AMBRO. What are some, just to interrupt? Dr. JOHNSON. One, pesticides; two, drinking water; three, inhalable particulates; four, mobile source&-air pollution; and five, complex effluents-industrial wastewater. Although these five committees were awkward because they included lots of people from various sectors of the Agency, they provided an essential communication to define objectives, goals, and plans. Where the committees were beginning to work, it was a very helpful form of communication. I think what our group feels is that such committees may be a means to an end, but somehow close coupling of communication needs to be institutionalized in order to cause the program office and the labora- tories to be more directly and closely coupled. Mr. AMBRO. Well, let us say that we believe there should be funda- mental research to support the promulgation of regulations. Is there a common thread among those areas where there is less dis- play of quality in the laboratories? Is that thread as you put it, no defined sense of mission, too broad a scope that they have and thus they do not know specifically where they are or why they are doing this? Is this a management flaw or does it result because of the diversity of review that the Agency has? Can it, indeed, be coupled in that sense? Dr. JOHNSON. I think it is both a management flaw and a situation of complexity. It would be unfair to say this is simply a management problem because, if you look at the mission of the Agency, it crosses a whole universe of subjects, very difficult to define in coherent bits. That complexity will remain as long as the demands on the Agency are as they are. My own opinion is that close coupling has occurred where there is a natural communication between the laboratories and the program office and that somehow the management could assist that process to happen. I think it is also necessary to examine how strongly the Wash- ington staff of 0. R. & D. becomes involved in "reprocessing" of in- formation. It may be there is an intervention that is not always necessary. Mr. AMBRO. Is the lack of communication a function of geography? Dr. JOHNSON. Geography can be used as an excuse and with restric- tion of travel funds, geography does become a problem but I have seen large organizations overcome geographical difficulties. Dr. WHITTENBERGER. There was substantial evidence that the success of the pilot research committee had to do with the leadership, which PAGENO="0190" 184 really involved two people-the chairman who was from ORD and who might be a laboratory director, and the cochairman who was from the program office. If those two people had good leadership qualities and wanted to work together then the activity was likely to be successful. Mr. AMBRO. It seems to me that when you deal with EPA as man- agers and you report your attitudes and views to them, are they sensitive to this and do they understand it and do they make an effort to remedy it? How does that work? I said earlier that you can tell us and we will tell them. Dr. JOHNSON. I would say not sensitive enough. I think there is a tendency to protect the research function. Mr. AMBRO. Protect and insulate? Dr. JOHNSON. Insulate, yes. Mr. AMBRO. Why? Dr. JOHNSON. I do not know. It is a phenomenon I do not understand. Mr. AMBRO. Are the research types those that seek insulation? Dr. JOHNSON. Sometimes it depends on their degree of self-con- fidence, but you must realize that this is a diffuse organization. It is difficult to get these communications through. We have communicated this observation back to the leadership of ORD and pointed out that they have some excellent examples of programs that are working ex- tremely well. These examples need to be examined and used as models. In our opinion, management by objective, which is now an old fashioned system of management, but effective, might be better util- ized. As part of the verbal report to the Grievence Advisory Board and Mr. Cöstle, I tried to put myself in his position and say, "all right, here is my research organization. What would I like in terms of results and what would be the indicators of whether these results are being achieved?" S The next step would be to establish goals, definite times or measure- ments amounts, but I did not go that far. I did give examples of results and indicators. Would you care to hear just a few of these? Mr. AMBRO. I would. I think you are right. It sounds like an improve- ment in management techniques. It is shocking that you would have to suggest this to anyone. S Dr. JOHNSON. Mr. Ambro, I am still part of a large organization. We spent 15 years trying to turn this complex organization around to utilize management by objective. It is complicated and requires very hard work. It does not happen automatically especially in research. Mr. AMBRO. Why it is shocking, is because one who sits as a member of this committee, reviews the efforts that we have made in space and the tremendous strides that we have made in the management of that program; that program and its management is light years ahead of that which any other nation has, and while we transfer technology, there is no question other nations would like that. One of the most prized things we have to offer to other nations in this area of tech- nology is the management of these kinds of programs; that we do not learn internally the basics of that kind of management and carry it over to another agency is astounding. PAGENO="0191" 185 Dr. JOHNSoN. I would like to pick up that philosophical point be- cause the space program had behind it all the necessary elements of science, no. new discoveries had to be made. It was a question of trans- lating science into engineering and technology. In a great many of the issues that EPA is facing, the science has not yet been developed. Moreover, the target is not that crisp and clear and singular. Therefore, the space program did have a distinct advantage, you see. Besides, it was new; it was not a creation of agencies from the past. Mr. AMm~o. That is most interesting~ E~r. JOHNSON. You might be inte~ested in some of these results and indicators as I would see them. IThe information follows:] Result Indicator Defensible data (and meth- Reports and publication accepted by peers. Data ods) for decisionmaking. sustained in court. Reduced controversy. Pro- gram office support. Agreed priorities. Fewer (or no) surprises Information available on time. Projects started in anticipation of need. Reduced controversy. Supportive Congressional oversight. Scientific integrity (credit- Peer support. Support of the regulated. Less con- able research base). troversy. EPA seen as a good place to develop a career. Publications in peer review journals. Cost effectiveness Favorable ratios compared with other labs. 0MB opinion. Professional research manager opin- ion. GAO opinion. Peer opinion. The foregoing are just examples. One could go to the "bottom line" and work backward to establish management by objective. These processes of thinking have happened in the water program and some other programs of EPA. I just hope that the Agency can catalyze a similar type of relationship throughout. Mr. AMBRO. What did Mr. Costle have to say? Dr. JOHNSON. He seemed interested. Mr. AMBRO. I think we are all interested and on that happy note I would like to once more, for what is left of the subcommittee, thank you very much for your appearance on a difficult day, and I know it mposed a hardship on you to get here, but I hope in reviewing your testimony we will be able to make a contribution. Dr. JOHNSON. Thank you. Mr. AMBRO. The subcommittee stands in recess, subject to the call of the Chair. [Whereupon, at 4:15 p.m., the subcommittee recessed to reconvene at the call of the Chair.] PAGENO="0192" 186 APPENDIX 1. THE PL~NNI~3 AND MANAGEMENT OF RESEAICH AND DEVELOPMENT ACTIVITIES WITHIN EPA A Report to the President and the Congress U.S. Environmental Protection Agency June 30, 1978 PAGENO="0193" 187 EXE~72IVE SUW~RY This report describes a study conducted by EPA in response to a directive contained in Section 7(c) of the Envirormental Research, Develop- ment, and Demonstration Authorization Act of 1978. Specifically, this study has two objectives: 1) to determine the causes of the operational problems identified in recent studies of EPA' s research management process; and 2) to develop specific corrective measures to alleviate these problems and assure the most effective use of the Agency's substantial research and developsent (R&D) resources. ~o intra-Agency groups were formed last year to achieve these two objectives. The first group was a policy-level cc*nmittee consisting of all th~ Assistant Administrators, the Executive Director of the Science Advisory Board and key Regional and laboratory representatives. This group was responsible for overall direction and decision-making. The second group consisted of Agency-wide senior staff members, whose function was to provide necessary analysis and support to the policy-level group. The analysis of the causes of the operational problems within EPA'S research management process revealed that the Agency lacked the fllowing fundamental cemponents: 1) a coherent research strategy which related program objectives and priorities to research activities; 2) effective canmunication and decision-making mechanisms between researchers and 43.778 0 - 79 - 13 PAGENO="0194" 188 programs; 3) an edequate program of long term and anticipatory research; 4) edequately responsive research results; and 5) consistent research quality. In order to gain insight into the specific mechanimus which might be used to alleviate these problems, the R&D management systems of the Fish and Wildlife Service, the Nuclear Regulatory Canmission, the Food and Drug Administration, and the Occupational Safety and Health Administration were examined. Certain aspects of each of these systems were incorporated into EPA's revised R&D planning and management system. The policy group determined that the Pqency' s R&D problems have not resulted fran the way the R&D program is organized so no provisions for major reorganizations are included in the revised system. The revised R&D planning and management system does, however contain five major canponents which differ significantly fran previous EPA R&D systems, and which are clearly linked to the five major deficiencies identified above. Specifically, these canponents are: 1) the identification of distinct research planning units around which coherent regulatory progranVresearch strategies can be developed; 2) the establisheent of permanent Research Committees for each research planning unit and a separate Research Oversight Committee composed of top EPA managers who will review strategy develop- ment and provide oversight throughout the R&D planning and iinple- mentation cycle; PAGENO="0195" 189 3) the tying of ~R&D planning and management processes into ~qency- wide management processes with decision rules focused on these connections; 4) a Research Incentive System designed to encourage responsiveness to Program and Regional research needs; and 5) the incorporation of peer review mechanisms throughout the plann- ing and management process to improve research quality. Since the revised system for R&D planning and management represents a major departure fran previous EPA systems, the policy-level group decided that it should be tested on a pilot-study basis. Five pilot projects ~re, therefore, initiated on March 15 and will be monitored closely for a six month period. The pilot areas include research activities in the areas of drinking water, industrial wastewater control, mobile source air pollutants, pesticides, and respirable particulate matter. A report on the pilot-study results will be provided to the Committee on Envirorinent and Public Works and the Committee on Science and Technology by October 31, 1978. This report will include a description of the experience of each pilot area, recommended changes in the R&D planning and management system based on the pilot experience, and steps undertaken to extend the approach to other EPA research and development activities. PAGENO="0196" 190 THE PLANNING AND MANAGEMENT OF RESEA~L AND DEVELOPMENT ACTIVITIES WITHIN EPA A Report to the President and the Congr~ I. P~~DUCTI~~ A. ~çpq~~ This report has been prepared in response tç) a directive contained in Section 7(c) of the Environmental Research, Development, and Demonstration Authorization Act of 1978. It also reflects more ~i&. ianging efforts by EPA to improve its research management capabilities. The purpose of the report is twofold: (1) To determine the causes of the operational problems identified in recent studies of EPA's research management process; and (2) To describe the specific corrective measures that are now being implemented in order to alleviate these problems and assure the most effective possible use of the Agency's substantial R&D resources. PAGENO="0197" 191 B. Recent Activities Two intra-Agency groups were formed last year to address the various concerns that have been raised in recent years. The first was a policy level canmittee consisting of all the Assis- tant Administrators, the Executive Director of the Science Advi- sory Board and key Regional and laboratory representatives with an interest in the coordination of program and research activity. This group was responsible for overall direction and decision- making. The second group was at the working level am ~ of senior Agency staff members, whose function was to provide the necessary analysis and support to the policy-level group. At the direction of the policy group, the staff had three major responsi- bilities: (1) Identify current problems in the planning and management of R&D activities; (2) Examine systems used by selected other agencies to plan and manage their R&D activities; and (3) Develop organization and management options for the conduct of the R&D program at EPA. PAGENO="0198" 192 II. ANALYSIS OF P~BLEMS A. Sunvuary of Problems The problems facing EPA's R&D program have been described and discussed by several Congressional ccxnmittees, the National Academy of Sciences, and the Office of Thchnology Assessment arid were confirmed by the EPA internal working group in its review. These problems include insufficient attention to long-term anticipatory research, a general lack of responsiveness to the programs' regulatory concerns and the uneven quality of EPA research. An analysis was undertaken of each of these problems to determine the underlying causes, looking particularly at the inadequacies of past EPA research planning arid management systems. A summary of this analysis is presented below. B. Causes of Problems 1. Inadequacy of EPA's Program of Long-Term and Anticipatory Research Both the Ccnunittee on Envirorinent and Public Works and the Committee on Science and Technology have expressed a special concern about the inadequacy of EPA's long-term and anticipa- PAGENO="0199" 193 tory research program. At the heart of this problem is the need for a clear EPA ccuuuithent to devote a significant part of its resources to well-t1xught-~out research projects which identify and address `potentially significant environ~ mental hazards. The appropriate balance between longer~terrn anticipatory and shorter~term programmatic research is largely a matter of experience and judgement. As described more fully below, EPA's early experience was that of attempting to ~ pieces of existing programs and organizations while at the same time trying to implement new legislation. The urgency of legislative mandates and the demands of forming a new organizational structure ccebined to create, an athosphere in which immediate concerns inevitably assumed priority over long-'range needs. In the past EPA has tried to improve research management and coordination by reorganizing various elements of its research program and by introducing a number~ of different planning and control metheds. *ile each of these changes was designed to correct one or more perceived problems, one aggregate result of so much change was to create the sense of continuing instability, which prcwoted sbort~'term problem solving, but worked against a longer range perspective,. PAGENO="0200" 194 Both the Agency aed the Congressional Committees with over- sight responsibility are now agreed on the need to correct this imbalance in EPA's research perspective. 2. Unresponsiveness The staff group identified the fqllowing causes for allegations that the research program is unresponsive to EPA's regulatory needs: (1) inedequate future planning by the regulatory programs; (2) inherent differences in perspec- tive between research ar~ program staff; aed (3) inedequate camnunications between the two staffs. Review of Agency program plans aed interviews with Agency program aed research staff strongly ir~icate that the Agency simply did not develop its program strategies in enough detail arx3 with specificity sufficient to permit identif i- cation of research needs aed priorities. Early research planning was characterized by solicitation of research ideas fran the regulatory program of fi~es. Although such a relatively common approach did yield numerous "research needs," it prpved impossible to manege, since there was no programmatic framework within which to assess potential utility aed to establish relative priorities. PAGENO="0201" 195 The secoed source of problems relates to the inherent dichotomy between researchers ar~ regulators. Researchers texx~ to approach problems fran a longer'~term perspective, whereas regulators must focus on more immediate concerns. Even when attempting to eddress immediate needs, researchers often require long leed-tixnes, both in coeducting aed in redirecting their research efforts. Regulators, on the other hard, are faced with immediate, often inflexible dem3lines which are established in legislation or court decisions or which grow out of the need to eddress unantic- ipated hazards. Regulators demaed a degree of respon- siveness which is antithetical to a stable research environment. Furthermore, researchers, by training ar~3 in response to the staedards of the research community, are deeply concerned with quality of the research. Their motivation aed pro- fessional recognition is based on the quality, not the timing of the work. Regulators, however, are primarily interested in the timeliness ar~ utility of information. They are sometimes forced to make judgments on the basis of the data which is available at the time the decision has to be made. PAGENO="0202" 196 Thus, an inherent set of tensions is created because of different professional experiences of and deiriands on researchers and regulators. While these tensions can never be fully resolved, they can be brought into a reasonable balance that best supports the agency's regulatory mission. Finally, and perhaps most significantly, there were few effective canmunications channels at the appropriate oper- ating levels of the organization. Effective linkages between laboratory directors and their research staffs with relevant program divisions and regional offices often did not exist. The complex, discipline-oriented organizational structure of the Office of Research and Development (OPD), with its fifteen laboratories, complicated communications problems. While the discipline orientation is not an insuperable problem itself, the lack of organizational alignment, with the structure of the regulatory program of f ices tends to exacerbate the communications problems. Without a systematic planning and management process to compensate for these organizational complexities, decisions have often been forced to the top of the organization, often to the. Assistant Administrator level, for resolution. But PAGENO="0203" 197 because of the limited time of top management to respond to the demand for ad hoc problem solving, many problems are simply never resolved, adding further to perceptions of unresponsiveness ard organizational isolation of ORD within the program and regional offices. Because of these long-standing canmunications problems, there is great skepticism within the ?i~ency as to whether any research management system can function effectively. Fears of paper-intensive planning systems, of undelivered pranises fran ORD, of the unwillingness or inability of the regulatory. programs to pay sufficient and knowledgeable attention to identifying their research needs, of the conduct of "closet" research by the program offices, and of the continued "isolation" of ORD fran the rest of the Agency reflect a history which must be appreciated in order to be overcane. 3. Uneven Quality of Pesearch. Under these circumstances the review, evaluation and quality control of research activities has been extremely difficult. This has resulted in the dissemination of research results of uneven quality. Also canplicating the problem of obtaining high quality research are the inter-related problems of attracting and keeping highly qualified staff within the constraints of civil service salaries and rules and requiring that senior staff assume supervisory duties in order to be pranoted. PAGENO="0204" 198 This report addresses the research quality issues that can be impacted by the planning and management process. The research personnel issues are being addressed in an associated study of EPA' s overall personnel management efforts. C. The Changing Situation A brief look at the history of EPA shows that the athtospheçe for program and research coordination has changed significantly over the last seven years. During its early years, EPA tended to operate in a crisis mode. The enactment of a continuous stream of new legislation during EPA' s formative years demanded that the top agency priority be the developoent and Implementation of regulations. This occurred while EPA was simultaneously attempt- ing to integrate a diverse set of programs and administrative units into a viable and rational new organization. While the research effort contributed vital information during this era and provided expert witnesses for judicial proceedings, much of ORD became increasingly detached frau regulatory concerns and came to be viewed as a bystander while the program and regional offices struggled to put the major regulatory building blocks in place. Thday, the legislative mandates of EPA are relatively stable. All parts of the Agency have attained greater organizational maturity. r~ore time can now be devoted to the interaction of PAGENO="0205" 199 research with the regulatory efforts. Furthermore, the exper~ ience gained in the early years of the Agency's existence has brought about a change in perspective that will be of great assistance in this effort. A heightened awareness of the importance of timely, credible research is developing. There is also a recognition of the need to use the Agency' s research resources more effectively. Finally, and most importantly, top management now has a camuit- ment to manage the Agency. Research management is only one of many activities under careful scrutiny. A wide range of reforms are now being proposed and implemented which include regulatory reforms, ZBB process improvements and personnel management reforms. The reform of the research management process is a significant element in this agenda for action. D. Relating Solutions to Problems In order to have impact, proposed solutions must be directly related to, and able to solve, the problems being addressed. While this seems obvious, organizational solutions are pre- scribed, more often than not, when, in fact, the underlying problems call for quite different remedies. This analysis includes a careful linking of identified problems with proposed solutions. PAGENO="0206" 200 The lack of a programmatic context for envirorinental research calls for the developnent of a coordinated program/research strategy. Only then can major goals and objectives be iden- tified, coherent plans developed and Implemented, and results evaluated. The lack of adequate calununication channels and decision-making procedures underscores the need for structured and meaningful interactions among the appropriate research, program, and regional staff, as well as outside experts. The inadequacy of the current program of exploratory research calls for provisions in the planning and management process to protect and enhance those longer-term efforts which have the potential to help solve future envirorinental problems. The perceived inadequacy of research findings in terms of usefulness and timeliness calls for innovative approaches through which program and regional offices can assure responsiveness to their regulatory and enforcement needs. Finally, the uneven quality of research results emphasizes the need for qualified peer review of research plans, protocols, and findings-in fact, that quality must be built into each step of the research planning and management process was an inescapable conclusion. PAGENO="0207" 201 ¶rhe following matrix sununarizes the results of our analysis. Problem Corrective Action Lack of research strategy - Program context for research management Lack of adequate cc*ninuni~ - Conununications ar~ cations arx3 decisior~-inaking problem solving at operational levels Inadequate program of long- - protection of long- term anticipatory tesearch term research activi- ties Inadequately responsive --~ Greater program ar~ research results regional influence arx~ responsibility Uneven research quality --- Incorporation of peer review throughout planning and management process E. Review of Systems. Used in Other Agencies In order to gain insight into the specific mechanisms which might be used to address the problems identified above, the R&D planning and management systems used in four other regulatory agencies were examined: PAGENO="0208" 202 * Fish and Wildlife Service (EWS) * Nuclear Regulatory Commission (NRC) * Food and Drug Administration (EDA) * Occupational Safety and Health Administration (OSHA) For each agency, the review consisted of two components: 1) interviews with key staff in the research office, in a program office, and in an edministrative or planniog office; and 2) an examination of relevant agency documentation such as organizational charts, functional statenents and planning manuals. As shown in Table A, the missions of these four agencies are quite different. There are also fundamental differences in the way each agency obtains R&D support for its programmatic activi- ties. In ~S, control of R&D funds rests with the program offices while all research is performed by ~WS's research office. The NRC, on the other hand, gives funding control for R&D to its research office which in turn "contracts" with the Department of Energy (DOE), where most of the work is performed. At FDA, R&D responsibilities are assigned to the program offices, which have their own research labs. Finally, OSRA, which is part of the Department of Labor, essentially has no research capability. Instead, OSHA relies on HEW's National Institute of Occupational Safety and Health (NIC~H) for the research needed to support its activities. PAGENO="0209" 203 While it was determined that it would be impractical and inappro- priate for EPA to adopt any of these R&D systems ~ ~ there are features of each model which~ were found to be of significant merit and were therefore incorporated into the design of EPA's new R&D planning and management system. Table B presents a summary of the major features of each agency's R&D planning and management process. Those features which are particularly relevant to EPA's R&D c~oncerns are marked with asterisks. These are the features that best addressed the basic problems identified above. 1. Program/Research Strategies. The review of the four agencies indicated that none of their R&D planning and management systems had evolved to the point where future planning such as required for the development of well-coordinated strategies was consistently being performed. Some, however, do have formal planning procedures which show particular promise for EPA. At NIOSH, the Director prepares a yearly research strategy in cooperation with an OSfl~-NICSH policy group. However, the strategy is quite broad in scope. FWS, on the other hand, requires its prcgram managers to prepare detailed strategy papers during the ZEB year which specify program 43-778 0 - 79 - 14 PAGENO="0210" 204 objectives and required R&D su~çort. These strategies are relatively narrew in scope since they relate only to one program manager's area of responsibility. If a middle ground could be found between these two forms of strategy developuent, .a viable metbed of preparing well-coordinated prcgranVresearch strategies could be developed. 2. Coninunications Between Researchers and Programs. Each agency examined hed at least one mechanism in place for resolving problems between program office and research managers. The mechanism employed by NRC appears to us to be the most edaptable to EPA's situation. Specifically, NRC uses standing Research Review Groups which meet on a periodic basis to resolve policy and technical issues encountered in the research program. Each Research Review Group, which consists of high level staff fran the program offices, the research office, and DOE laboratories, is responsible for reviewing a particular research area. The Research Group is also assisted by outside experts. 3. Ways to Assure Responsiveness and Protect Long-term Research. Since responsiveness of research to program needs and the maintenance of long-term research capabilities are inter- dependent, both will be discussed here. The mechanism used in PWS offers one metbod for ensuring research respon- PAGENO="0211" 205 siveness. FWS gives R&D fundiog control to its program offices. FWS feels that this arraagement gives the program offices a vested interest in research since they must take responsibility for seeir~ that R&D funds are spent on research which supports their needs. At the same tine, the researcher feels the incentive to be responsive since fundiag could be withdrawn if he does not perform in accordance with the program's requests. EWS has no formal mechanism for protectiog bog-term research. However, agency staff stated that there is an informal under- standing that some of the program offices' R&D funds will, in fact, be spent on long term research. 4. Research Quality. Maintenance of a consistent quality of research is a goal that is not unique to the four agencies examined or to regulatory agencies in general. Cach of the four agencies does have a procedure to be followed in the evaluation of research (Table B). Some of the agencies also have procedures established to ensure transfer of research results. For example, at the NRC following the evaluation of research, a Research Information Letter (RIL) is prepared which includes a brief technical description and identifica- tion of the user need, an executive sunnary of principal PAGENO="0212" 206 results and their significance to NRC, and a concise descrip~ tion of the evaluation of the results including the rarqe of applicability. F. Analysis of "Organizational Solutions" In reviewing the organizational arrangements in other agencies and in CPA, the issue of a possible reorganization of the EPA research program was addressed. Both centralized and decentralized systems were analyzed. While there are advantages and disadvantages to each approach, the critical issue beccines whether or not the problems facing EPA's R&D program have resulted fran the way it is organized. The Policy Group reviewed a number of options for R&D in EPA which paralleled the organizational arrangements in other agencies, but ultimately rejected them. The reasons for rejecting options requiring reorganization were: o Current organizational arrangements are not at the core of the problems facing the Agency's R&D effort. o ORD has, in its short existence, already gone through several reorganizations, each with an increasingly severe impact on morale. o A reorganization always disrupts ongoing activity. When that ongoing activity consists of research projects typi- cally lasting two to four years, the potential costs in PAGENO="0213" 207 terms of projects that are aborted or seriously disrupted is considerable. * In examining the possibility of reorganizing EPA's research function along program lines in a manner similar to that of FDh, it was found that: - Such a reorganization would be hindered by EP1~'s large number of geographically dispersed laboratories and by the fact that many are simultaneously supportive of several different programs. - A decentralized research program such as FDA's nay result in duplication of research effort. * EWS's, and to a certain extent NRC's, organizational arrangements are similar to EPA's. * The OSHA/NIOSH arrangement where research and operational programs are located in separate Departments does not seem to offer a useful model for enhancing the responsive- ness of research activities to regulatory needs. The Policy Group, in rejecting solutions which were dependent on major reorganization, asked rather that management system changes be proposed which would bring about the desired improvements in the functioning of the Agency' s research program. PAGENO="0214" 208 III. R MMENDED SYSTEM The system that is being recaiunended for implementation in the planning and management of research and develope~nt in EPA has five major canponents: 1) the identification of distinct research planning units based on regulatory programs; 2) the establishment of permanent Research Canmittees for each research planning unit and of a separate Research Oversight Ccminittee canposed of EPA's top management; 3) the tying of R&D planning and management processes to P~ency~ wide management processes with decision rules focused on those connections; 4) a Research Incentive System designed to assure responsiveness to program and regional research needs; and 5) the incorporation of peer review mechanisms throughout the planning and management process to improve research quality. These design features are directly linked to the five major problem areas identified earlier (See Table C). Each of these features is discussed in detail below. PAGENO="0215" 209 A. Research Planning Uni This analysis has shown that many of the problems associated with EPA's R&D program would be alleviated if a set of carefully laid-out regulatory progranVresearch strategies were to be developed around a logical planning framework. The conceptual basis for the EPA R&D planning and management system will be clusters of R&D activities which, because of their inherent interdependencies, should be planned and managed as a unit. The following are examples of possible research planning units: * hazardous air pollutants * toxic pollutant control * nonpoint source pollution control o hazardous waste disposal * safe drinking water In many cases, research planning unit~ will be "multi-media" and will cross program lines or research category and budgetary boundaries. "~xic pollutant control" is an obvious example since three program offices have a stake in this area of research activity. Within these research planning units, major goals and objectives can be defined and relative roles and responsibilities for the conduct of research clarified. It is expected that 15-20 such research planning units will eventually be identified with each having $l0-25 million in resources. PAGENO="0216" 210 B. Research CaTinittees In order to facilitate effective canmunication between ORD, Program Of f ices, aed Regions in overseeing the planning arx~ coeduct of research during ZBB, planning, and implementation years, Research Committees will be established for each research planning unit. Each Research Camnnittee will be chaired by a Research Manager designated by ORD and will have representatives fran relevant client offices (Program Offices and Regions). Regional representatives will be selected by the Regions collectively. The services of experts fran other Agencies and fran outside the Federal Goverrinent will also be used. Each Research Canmittee will be a permanent body with continuing responsibilities throughout all phases of the R&D cycle. Specifically, the Research Ccmnmittee will be responsible for: * developing a multi-year research strategy which is based on the relevant regulatory Program strategy, and which identifies Agency research goals and objectives as well as broad Program and Regional research output requirements, * reviewing and suggesting appropriate modifications in related ORD, Program Office and Regional EBB decision units which include research canponents in order to assure their respon- PAGENO="0217" 211 siveness to approved research strategies and their consistency with regulatory canponents of those same and other decision units; * analyzing relevant research decision units in the ZEB process; * monitoring progress during the planning and implementation years against approved strategies and implemention plans and suggesting corrections for significant deviations to the relevant ORD unit; * serving as the primary forum for resolving R&D issues enc.~"~- tered by the Program Offices, the Regional Offices, or ORD during the planning and implementation years, or if unsuccessful, referring the issues to the Research Oversight Committee; * as tine allows, reviewing and evaluating research results; and * as time allows, reccirunerx3ing the appropriate timing and means for disseminating specific R&D products. The Research Committees, however, will act in an edvisory capacity only and will raise major unresolved issues to the Assistant Pdminis- trator for Research and Development, who will negotiate a resolution with the appropriate Assistant and Regional Administrators. Issues still unresolved will be raised to the Research Oversight Committee. Research PAGENO="0218" 212 Coennittees will not assume the operational responsibilities of CRD, the Program Offices, or the Regional Offices. The developoent of Program strategies, ZBB decision units, implementation plans, project workplans, routine project evaluation, etc., will remain line management responsi- bilities. Research Coennittee Purview. Research arx3 developeent activities in EPA ate grouped into three basic categories, not all of which may be relevant to any particular research planning unit. These categories are defined as follows: a. Exploratory R&D* - research which is corx~ucted primarily for the purpose of developing fundamental knowledge arxi principles appli- cable to the solution of currently intractable problems or scien- tific questions, or research which is aimed at identifying or understanding envirornnental problems on the horizon for which no specific regulatory activity is currently contemplated. b. Regulatory/Operational Support R&D-research in response to identified program or regional office operational requirements, or research designed to test current ~ency, Program or Regional assumptions but which is not immediately required in support of ~he Exploratory category will include, but not be limited to, the Anti- cipatory Research activities funded under the Interdisciplinary budget category. PAGENO="0219" 213 planned regulatory actions. It also includes technical assistance support services --- in response to ad hoc needs or special requirements that cannot be planned in detail during normal budgeting and planning cycles. c. Assigned Mission R&D-research in response to missions speci- fically assigned to EPA by Congress, the White House or ~1B beyond the general requirements of the Pqency's enabling legis1~on. Examples include the Interagency Reergy/E~virc~ent Program and the Biological and Climatic Effects of Radiation (BACER) Program. Most Research Committees will be responsible for research which is primarily regulatory/operational áupport in nature. Nevertheless, these Committees will be expected to address relevant activities fran all research categories that fall within the purview of the Committee's research planning unit. This will include appropriate portions of the Exploratory R&D and Assigned Mission R&D categories. In addition, the Office of Research and Development will establish Research Committees for the Exploratory R&D and Assigned Miggions R&D categories. These two Research Committees, which will be chaired by the Assistant Mministrator for Research and Development, will include Program and Regional representatives and draw on outside experts for consultation. The jurisdictions of these two committees will partially overlap with those of the other Research Committees. (See Table D). PAGENO="0220" 214 In addition to conducting their own independent deliberations, the Exploratory and Assigned Mission Research Canmittees Will receive recanmerx~ations fran the other Research Camnittees and will integrate then into their priorities. The Exploratory R&D Canmittee will also receive and incorporate recommendations fran a "bottom-up" planning process as called for in the report of the National Academy of Sciences. Such a process would allow laboratories and bench-level scientists to propose implenentation of specific longer-term research projects. In the case of Assigned Mission R&D, the Research Committee will assure the consistency of its recaninendations with priorities set by Congress, the White House, and 0MB. As with all Research Caninittees, the activities and recatunendations of these last two Committees will be subject to review by the Research Oversight Ccxnmittee (see below). The Office of Research and Development will normally be responsible for the detailed planning and implementation of projects in the Exploratory and Assigned Mission categories. However, when changes are made in the programs in either of these categories which night directly or indirectly affect Regulatory Support R&D, it is the' responsibility of the Assistant administrator for Research and Development to inform the affected Research Committees. PAGENO="0221" 215 In eddition to the Research Committees, a Research O~,ersight Committee composed of the Assistant Administrators and of those Regional Adminis- trators naned by the Deputy Administrator will also be established. It will be chaired by the Assistant Administrator for Research and Developeent and have general responsibility for reviewing the activi- ties and recommendations of all Research Committees and for resolving all issues that cannot be resolved at lo~r levels. Specifically, it will be responsible for: o reviewing and approving multi-year strategies developed by Research Committees; o giving overall policy direction to the Research Committees and to the agency with regard to research activities and resolving major operational problems regarding the conduct of research or research planning; and o overseeing, with the Science Advisory Board, evaluation by the Research Committees of research products and, as neces- sary, reviewing and approving Research Committee recanmen- dations regarding the appropriate timing and means for disseminating research products. C. Inteqration of R&D Management and Planning with EPA Planning Process It is considered crucial that the planning and management system for R&D be carefully tied to the ongoing management system of EPA and that PAGENO="0222" 216 clear well-defined decision rules be applied. Some of these decision rules will act to foster long-term research aid assure its relevance to potentially significant regulatory needs. The following section describes the relationship of the new R&D planning and manegement System to the Pgency strategy formulation aid ZBB processes and to planning aid implementation activities. 1. Pre-ZBB Strategy Developnent. Each Research Committee will develop a strategy that aiIdresses all phases of the relevant research activity. The research strategy will delineate the major goals and objectives for the relevant areas of research activity. Sti~ 6 research strategy will, whenever possible, be developed within the context of a pre-existing program strategy. Outside experts will be asked to play a significant role in the developoent aid evaluation of this strategy. All EPA research funds (e.g., ORD, Program, Regional) will be encompassed in the research strategy document as appropriate. Prior to the developnent of multi-year research strategies by the Research Committees, it will be necessary for the Program and Regional Offices to have carried out the following preliminary activities: * prepare an inventory of all statutorily mandated or court ordered program requirements aid of all other specific program needs, PAGENO="0223" 217 * prepare a tinetable of required completion dates for each of the above activities, * identify all technical information needed to carry out the above activities, and * identify all information gaps and the tine frame within which these gaps must be filled. This last item will be the major Program/Regional input to the Research Committees' strategy developsent process. Completed strategies will then be reviewed and approved by the Research Oversight Committee. The Assistant ~dministrator for Research and Developuent, with the edvice of the Research Oversight Committee and after consultation with the administrator, will define the general resource levels by planning unit, for the Exploratory R&D and Assigned Mission R&D categories. 2. EBB. The R&D elements of the ZJ3B decision units will be based on the specific research planning unit strategies devel~ed by the Research Committees. They must also be consistent with any asSociated program decision units. Program decision units should, if possible, be drafted prior to the drafting of research decision units. 3. Planning Year. Detailed research planning and execution in response to approved strategies and objectives will normally be the responsibility of ORD. Accomplishment plans for R&D activities will PAGENO="0224" 218 be prepared by ORD or the -responsible Program or Regional office and submitted to the Research Ccmmittee for review and canment. Reorien- tation of the plans, as appropriate, will be recorunended to ORD or the other responsible office by the Research Committee. In the case where Program or Regional Offices wish to implement specific extramural R&D activities independently, ORD will be given the opportunity to review the research proposals to determine if there is any duplication with past, ongoing, or planned ORD activities, and to comment on the technical quality of the proposed activities. Finally, under the Research Incentive System, a portion of the research funds may be allotted to a Program or Regional Office rather than to ORD. ~en this does occur, ORD will, within agreed-.upori time constraints, be given a1equate opportunity to negotiate for the opportunity to conduct that research intramurally or to provide contract monitoring services to the sponsoring Program or Regional Office. If the Program or Regional Office accepts ORD's offer, the management details (costs, timing, form of output) will be negotiated between ORD and the client office. 4. Implementation years. The Research Committees will review progress periodically in response to the research strategy and implementation plans during the ii~plementation phase of the R&D cycle, and report on - an exception basis to the Research oversight Committee. PAGENO="0225" 219 As time allows, the Research Ccmimittees will also review ar~ evaluate results in terms of technical quality aod operational responsiveness. Both Pqency aod outside experts will be used to cor~3uct such reviews. The Research CQlunittees will also, as time allows, identify the appropriate timing ai~ method of dissemination of specific R&D outputs. D. Research Incentives System The Research Incentives System (RIS) will constitute an important element of the proposed R&D planning ar~3 management system. The primary purpose of the RIS is to establish a mechanims to encour~ age ORD to be responsive to Program ar~ Regional needs ar*3 to encourage Program aod Regional Offices to take seriously their responsibilities for clearly articulating their research needs and for following the progress of key research projects. The RIS would establish a client-V contractor relationship between ORD and the Program and Regional Of fices. It would require ORD and Program and Regional Offices to work together effectively, to avoid the results of failureS-loss of research resources by ORD, and assumption of day-.to-day research management duties by the Programs or Regions. We are now considering a number of variants of the RIS, one of which will be discussed for illustrative purposes. During strategy develop- ment, Program and Regional Offices would identify areas of research 43-778 0 - 79 - 15 PAGENO="0226" 220 that they feel they should more closely man~e because those areas are key to the success of their regulatory efforts in the near-term. Program aud Regional Offices, with the assistance of OPD, would develop appropriate proposals to incorporate into the ZBB decision units. The ZBB ranking process would then be used to determine the relative priority of such proposals. Based on ZBB decisions ar~ Congressional action, implementation plans for activities assigned to Program or Regional Offices would be developed by those Offices. The Offices would then negotiate with ORD to couduct the research within its laboratories or to proczide contract management services for the Progra~fRegional Office projects. Ai~ernatively, the ProgranVRegional Offices, after consultation * with ORD, could contract directly with outside firms to couduct the desired research. Through judicious use of the RIB, all managers - Assistant Administra- tors, Deputy Assistant Administrators, aud Division Directors - can be given a greater say in project direction for those projects that will contribute significantly to meeting their program needs. The effect of establishing a Research Incentive System will therefore be to enhance the impact of the Research Committee System in promoting openess arx3 responsiveness in ccinmonications between research managers aud program managers at all three management levels. PAGENO="0227" 221 In order not to overshadow the positive effects of increased research responsiveness which would grow out of this system, however, it is necessary to build in safeguards against potentially negative conse-~ quences. Tb avoid undue instability in ORD research efforts, it could be specified that a percentage of research funds managed by ORD in the previous year would continue to be managed by that organization. For example, the ProgranVRegional Offices could be required to spend 90% of those funds within ORD. Further limits could be placed on the extent of reprogramming of ongoing projects by the Program or Regional Of f ices without the concurrence of the Assistant ~ministrator for ORD. Since the Research Inôentive System would be operated within the context of agree&-upon research strategies, ZBB decision units and implementation plans, changes in program emphasis or direction would not be made beyond those necessitated by unanticipated needs. Such an approach to the Research Incentive System would have obvious benefits for the Program and Regional Offices which depend upon research findings for their regulatory efforts. These Offices could participate as they chose in the development and approval of research protocols, thereby enhancing the likelihood that the outputs will be specifically tailored to their needs. PAGENO="0228" 222 ORD also has much to gain fran a Research Incentive System. Under the current arrangement, requests for new research support are often made to ORD without regard to the relative priority of those requests and without a sense of what research activities are delayed or disrupted by the new requests. The new system instead requires that the Programs/ Regions articulate and set priorities among the requests that they make of CIRD. By allowing ORD to choose whether or not to "bid" on key projects, the P15 will allow ORD to set its prices canpetitively in order to develop in-house research capability, especially in emerging areas. Clearly, whatever variants are selected by the pilot studies, the P15 will have to be applied flexibly in order to meet th~ special condi-' tious of each research planning unit. In general, however, growth areas or those with many short-term projects can probably respond most effectively to such a system. E. Research Quality. The incorporation of peer review mechanisms throughout the planning and management process is fundamental to the success of the proposed R&D planning and management system. Each research cartmittee will use such mechanisms during the planning, implementation, evaluation and dissemination stages of research. Ccnunittees will address the following questions: PAGENO="0229" 223 How should "technical quality" be measured? * ~that is the appropriate mechanism for making the tra5e-off between timeliness of response and thoroughness of analysis? * How and by whom should the product of research be presented to the client/user? * ~at mechanisms should be used to ensure that researchers receive feedback on the timeliness, quality, and utility of the products of ongoing or completed research efforts? IV. ACTIVITIES UNDE1~AY TO IMPLEME~ THE SYSTEM The Policy Group, after agreeing to the R&D planning and n~nageeent approach decribed above, concluded that it would be prudent to test the system in several pilot projects. In this way, the many facets of the system can be thoroughly tested and modified or possibly rejected in order to increase the prospect for the system to work effectively as it is applied to other parts or all of EPA's R&D progran. Five pilot areas have been selected. They represent five "natural" areas of research planning which are of major importance in EPA's regulatory and research efforts. They include one, area (respirable particulates) which both is specific to a regulatory progran (air quality) and cuts across all areas of research disciplines. The PAGENO="0230" 224 other four are also specific to a single regulatory program but are concentrated in only one or two research disciplines (drinking water, industrial wastewater control, mobile source air pollutants and pesticides). The jurisdiction Qf each of the five pilots falls within the boun-~ daries of a single Program Office but this need not always be the case. When the pilot project is completed and additional Research Cosunittees are established to cover the bulk of EPA's research activity, some Committees may have responsibilities which cross program boundaries. During the pilot period, the recommended R&D planning and manage- ment ~tem is being applied within each of the five pilot areas. The Research Committee established for each pilot is composed of relevant ORD, Program, and Regional staff and will be assisted by outside experts. Each Research Committee will develop a brief research strategy, participate in the 1980 ZBB process, and review and, where appropriate, make recommendations for reprogramming of research activities planned for FY-~79 and of research underway in FY-78. To the extent possible, variants of the Research Incentives System will be tested. The pilot projects were formally initiated on March 15, and will be monitored closely for a six-month period. A report on the pilot experience will be provided to the Congress by October 31, 1978. PAGENO="0231" 225 This report will include a description of the experience of each pilot study, reccinmerded changes in the R&D planning arid management systøn based on the pilot experience, arid steps taken to extend the system to other parts of EPA's research and development activities. PAGENO="0232" Table A. Target Agencies for R&D Progran Analysis AGENCY MISSION 1~ conserve the Nation's fish ard wildlife resources AGENCY O1~ANIZATION Three Progran Offices, Six Regions arK3 the Alaska Area Office (which include approx- mately 600 field stations) report directly to the Director of F~'E in Headquarters. R&D P~)GRAM CHARACTERISTICS FUND Tk4D1 ~ CO~fl~1OL I. Nuclear Regulatory Commission (NRC) 1~ regulate all civilian rvclear activities Five Progran Offices: o Office of Nuclear Material Safety ard Safeguards o Office of Nuclear Reactor Regulation o Office of Nuclear Regulatory Research (RES) o Office of Stardards Development o Office of Inspection ard Enforcenent All report ta the Execu- tive Director of NRC Assigned to Centralized mana~enent RES responsibility in RES. Centralized iinplenentation responsibility in Department of Energy (mardated by legis- lation) * Fish ard Wildlife Service (F~) Assigned to operatiog progran manajers in Headquarters RES~NSIBILITY Centralized urder the direct control of the Associate Director for Research in Headquarters PAGENO="0233" Table A. Target Agencies for R&D Progran Analysis IV. Occupational Safety and Health I~dminis- tration (OSHA) ¶Lb regulate tte safety of tbs Nation's fi)Ods, cosmetics, drugs, medical de~rices, biolcgics, and electronic raiio- logical products 1~ as&re that no worker suffers diminisbsd health, reduced fu~ction capacity, or decreased life mcpectancy as a result of his work experience. Six Agency Bureaus: o Foods o Drugs o .Veterinary Medicine o Raliological Health o Biologics o Medical Devices o DiajnostiC Products report directly to the Commissioner. Also reportir~j directly to the Com- missioner are tha National Center for ~xicological Researth (NCTR) and the Executive Director of Regional Operations (EDRO) OSHA located organiz- ationally within the Department of Labor and has no researth capability. OSHA gets researth support from the National Instithte for Occupational Safety and Health (NIOSH) ~thich is a part of tbs Deparbient of Health, Education, a~f Welfare. R&D PROGRAM CHARACFERISTICS FUND IMPW4E~ATICN CONTROL RESRONSIBILIT! Centralized in progran office labs Assigned to Centralized impiemen- NICSH tation responsibility in NIOSFI AGENCY III. Food and Drug Administration (F~) MISSION AGENCY OIGANIZATION Assigned to Bureaus and EDRQ PAGENO="0234" Table B. Features of R&D Plannirj aid Mana3eiuent Systeus Used in Target Agencies R&D PLANNING ~\ND M1\NAGEMEI~TI' P1~)CESS I. FWS 0 Prograti strategy state- ments prepared by progran manajers on a year-to- year basis * "Bottom up" aid "top dc~,n" mechanians for surfacing R&D proposals to support strategy * Progran Manager Strategy Papers prepared by progran to stxw which R&D projects support progran objectives. * Associate Director fOr Research "costs out" - proposals * Decision units prepared by area aid regional offices o Detailed project planning performed by Research Of fice with fran progran of fices *J~fl research funds assigned to Progran Manajers o Progran advice pre- pared by Progran Manajers which makes funds available to Research Office o Formal progran reviews every 6 months o Progran review~ of completed research every 6 to 12 months AGENCY STRATNGY LEVELOPMENT ZBB PLANNING IMPLEMEt~ATION EVALãI~TIGN PAGENO="0235" Table B. Features of R&D Planninj and Mana)ement Systens Used in Target Agencies R&D H~ANNING AND M NN3EMENT P1~)CESS sTRATaiY AGEPCY 1~VEUPINT ZBB PLANNIND IMPLE]4ERfATION ~VMLWFION (.NRC/DOE. 0 Coordinators designated 0 Coordinators "weed * RES does all 0 RES mana~es all 0 RES Assistant by progran offices to out" usnecessary plannirN bet research projects Director chairs oversee identification duplication must have pro- conmittee canpos- of research needs and coordinate gras office * RIGs reviews ed of progran actions required "sponsor" interim outputs offices aid RES to arrive at before plans and progress representation ajreenent on can be final- reports aid which may proposed research ized include meabers o Research proposals * Stariliog Re- of RIG aid cut- stt*nitted to search Review side experts to Off ice of Nuclear Groups, (RIGS) review respon- Research (RES) of high-level siveness of o RES rules on staff fran pro- research validity of pro- gras offices, posals; Prograns RES labs, otber have appeal ajencies and rights to Execu- outside experts tive Director sot as over- o RES prepares sight panels decision usits on technical problems encountered (br- irg tbe planniog year PAGENO="0236" Table B. Features of R&D Planni.-ij aed Management Systems Used in Target Agencies R&D PLANNING AND MAN~EMENT PROCESS SThATFIW AGE~Y rmVEL~f~ENT ZBB PLANNING IMPLEMENTATION EVALtWI~ION III. LDA 0 Progran managers within the bureaus recanneed progran goals arx3 objec- tives. Subject to concurrence by the bureau management, the plans are prepared aed presented to the Ccmnnission during the planning process as the Bureau's Pr~osed Accanplishnent Objec- tives. o pp~ updated annually to assure coverage of problem areas o Level of effort for R&D defined during the Accanplisheient Objective pbase of the Planning Process prior to ZBB. o Progran managers prepare decision units. o UBottOffi -up" mechanisa for surfacing arni rarEing R&D proposals. along with all other progranmatic proposals. o Office of Planning ard Evaluation ard Of fice of Administration identify allocation decisions for Ccinmissioner o Canmissioner designates fiscal year priorities an3 deter- mines needs for realloca- tion of funds. o Detailed plan- ning performed by progran managers. o All research implemented by progran office labs, one or more of the 20 field labs, or 1~CTR. o Face-to-face brief jag of Canmissione ard his top staff by progran nanajec on progran accon- plisheents. C PAGENO="0237" Table B. Features of R&D Plannin3 aed Mana3ement Systems Used in Target Agencies R&D H~ANNING AND MANAGEMEif2 P1~JCESS STRATEDY AGENCY 1EVELCP('E~1f ZBB PLANND~ IMPL84EtIfATICN FWMA~TION IV. OSHA/ * Research develcpsent * Management Ccimuit- 0 Appropriate 0 All research ~OSW~-NI(~H workin NIOSH performed by NICEH tee chaired by NIOSH Research implemented by Groups evaluate Director with imputs NIOSH Director Division appropriate quality aid from CS~-NIC6li- Policy aed composed of Directors do NIOSH Research responsiveness Group top NIOSH officials detailed plan- Division of research prod- appoints members niog bet must o PCCR reviews urts aid brief of Progran Commit- get PCCR interim outputs OSI~ officials. tee for Coordinat- ajreenent on aed progress iog Research (PCCRs) outputi for reports * PCCR5 surface allocation of o OSHA representatives research needs, f~mds aid are also invited aid Mwsed outw positions to participate in duplicative tCCR reviews research o NIOSH Division Directors pre- pare decision uaits PAGENO="0238" Table C: RELATIONSHIP OF PROPOSED SYS'IEM TO DEFINED PROBLEMS AND SOLUTIONS PROBLEMS LACK OF RESEARCH STRATEGY INADEQUATE COMMUNICATIONS AND DECISION-MAKING MECHANISMS INADEQUATE LONG-TERfl RESEARCH PROGRAM INSUFFICIENTLY TIMELY/USEFUL RESEARCH FINDINGS UNEVEN RESEARCH QUAL ITY APPROACH PROGRAM CONTEXT FOR RESEARCH COMMUNICATIONS AND PROBLEM SOLVING AT OPE RATIONAL LEVKLS PROTECT LONG-TERM RESEARCH GREATER PROGRAM AND REGIONAL INFLUENCE AND RESPONSIBILITY MORE QUALITY REVIEW THROUGHOUT PLANNING AND MANAGEMENT PROCESS SYSTEM FEATURES NATURAL MODULES FOR RESEARCH PLANNING RESEARCH COMMITTEES R&D PLANNING TIED TO EXPLORATORY RESEARCH COMMITTEE; AGENCY SYSTEMS IN DECISION RULES AND SAFEGUARDS RESEARCH INCENTIVES SYSTEM PEER REVIEW THROUGH RES EARCU COMMITTEES PAGENO="0239" TABLE D: RELATIONSHIPS AMONG THE PROPOSED RESEARCH COMMITTEES PAGENO="0240" 234 APPENDIX 2. I ~ TI ~ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 JAN 31979 THE ADMINISTRATOR Honorable George E. Brown, Jr. Chairman, Subcommittee on the Environment and the Atmosphere Committee on Science and Technology House of Representatives Washington, D.C. 20515 Dear Mr. Chairman: In response to a directive contained in Section 7(c) of the Envi- ronmental Research, Development, and Demonstration Authorization Act of 1978, a report entitled "The Planning and Management of Research and Development Activities Within the Environmental Protection Agency" was submitted to the Congress on June 30, 1978. That report describes a study, ~hicb began in July of 1977, aimed at: 1) determining the causes of the operational problems identified by the Congress, the National Academy of Sciences, the Office of Technology Assessment, and the Environmental Protection Agency; and 2) developing specific corrective measures to alleviate these problems and assure the most effective use of the Agency's substantial research and development (R&D) resources. The enclosed report summarizes both the specifics of the problems addressed in the June 30 Report and the actions taken to alleviate those problems. Specifically, it outlines the basic elements of the Research Committee Pilot Study initiated. on~March 15, 1978,. and. will provide, you with a status report on that Research Committee system. This status report was promised. to you in our report of June 30. - The Subcommittee on Resource Protection of the Senate Committee on Environment and Public Works identified two primary problem areas with which they were concerned: 1) the widespread perception that EPA's research program did not adequately support the Agency's regulatory mission; and 2) the inadequacy of the Agency's long-term and anticipatory research. The first of these problems has been characterized as a lack of responsiveness of the Office of Research and Development (ORD) PAGENO="0241" 235 to the Agency's regulatory offices. 14y recent testimony and that of the Agency's Assistant Administrators before your Subcommittee clearly reflected the improved relationship between ORD and the regulatory offices.* I believe that this is a result of the close working rela- tionship which has developed among the senior rnanagers of the Agency. It is my firm belief that the Research Committee system, which we plan to expand significantly, is providing the mechanism needed to encourage a similarly close relationship between researchers and regulatory of fi.~ cials at lower levels in the Agency. The second problem area-the perceived inadequacy of the Agency's exploratory research program-has been mdre difficult to alleviate. We have received mixed signals from the Congress with regard to the importance placed on exploratory research. We at EPA feel that anti- cipatory research has been slighted in the past and that we need to significantly expand this program. The Senate Committee on Environment and Public Works reinforced this position. However, our request for additional funding for anticipatory research for fiscal year 1979 was drastically reduced leaving us with an inadequate program. We hope that the Congress will reaffirm its support for the expansion of explo- ratory research in EPA. In the interim, I intend to convene an Exploratory Research Committee which, when added to the Research Committee system, will provide EPA with an improved program o~ anticipating future environmental problems. If you have questions concerning the enclosed report, I certainly wil~. be happy to respond to then. I look forward to updating_af~eport on the Research Committee system in both t authorizati~p.4~nd appropri- ationa hearings in early 1979. :~~:: Enclosure I 43-778 0 - 79 - 16 PAGENO="0242" 236 Status Report To The Congress . . Pilot Study of: the Revised' ` ` .. * " Planning and Management System `. . .. * . . . . For `Research and Development in the Environmental Protection Agency , ``. . ." .. As the second phase of a ccmprehensive review of' research planning and management, the Environmental Protection Agency (EPA) initiated a series of pilot research planning studies in March 1978. These pilot studies were' undertaken as' a result of the findings of the first ph~se of the review (as - reported in "The Planning and Management of Research and Development Within EPA," submitted to the Congress on June 30, 1978). `~ The primary purpose of the canprehensive review is to. address two critical perceptions of EPA's research and development. (R&D) efforta: (1)' that EPA'S R&D activities did not adequately support thà Agency' s" rigulátory pràgrans, and (2) that the longer-'term and anticipatory ccmponents of the- R&D program were insufficient. As described' in the June 1978 report, the Phase I study proposed a revised R&D planning and management system as a response to the criticisms. The revised system embodied five malor ccmpo- *nents, namely: -: ```:::~.``~` . *.` .. .. . ` 1) the identification of distinct research planning units around which :... coherent regulatory program/research strategies can be developed; PAGENO="0243" 237 2) the establishment of permanent Research Committees for each. research planning unit and a separate Research Oversight Committee canposed Of top EPA managers who will review strategy development and provide oversight throughout the R&D planning and implementation cycle; 3)~ the integration of R&D planning and management processes with Agency-' wide management processes, with decision rules focused on these con~ nections: 4) the use of a Research Incentive System designed to encourage respon- * siveness to Program and Regional research needs: and * 5) the incorporation of peer review mechanisms thrqiaghout the planning and management process to improve research quality. As the June 1978. report indicated, Research Committees were formed . around five research planning units-'-Drinkin~ Water, Industrial Wastewater Control, MobiLe Source Air Pollutants, Pesticides, and Respirable Parti-' culate . Matter (later renamed as Inhalable Particles). Each Research Committee was ccmposed of~ appropriate research, regulatory program, and regional staff members. A listing of the membership of the respective ccsnmittees is attached. . * .. * . -... . .: . Each of the Research Committees was asked to perform four primary tasks.* First, they were to review the current FV-78 program in order to determine whether or not any immediate research redirection was PAGENO="0244" 238 desirable. Second, each committee was asked to review the' FY~79 operat~ `ing plan.,' including `review of the F!-~79 decision units `(Du's).., Third, the committees were charged with the task of fully participating in the formulation of fl-SO research decision units, and with providing a wstraw..man~ ranking of decision levels within those DU's which fell under * the purview* of their respective, committees. Finally, and sost important, each committee was asked to formulate a multi-year research strategy `which could provide the basis for the Agency's future plaàning. . To date, we feel that ccmmitteeà have successfully performed the first three of these tasks and that, by doing so, they have greatly' enhanced the responsiveness of EPA'S research program ~o the `needs of the regulatory programs.. For example, activities of the Mobile Source Research Committee led directly to a significant redirection `of the fl-78 `research program. Funds were `redirected into a study on carbon monoxide intrusion into motor vehicles and into assessing the carcinogenic risk Of parti late matter' ftcat `diesel engines. The Mobile Source Research Committee also affected the FY-1~ research operating plan by identifying the need for reprogramming of $1.0 million of ORD resources to support diesel particulate research. Similarly, the Committee influenced an Agency decision to add a second' $1.0 million from other Agency funds to the diesel research effort. Both the FY-78 redirection and the FY-79 reprogramming respond directly to the shift in priorities within the Office of Air, Noise and Radiation. PAGENO="0245" 239 There are other substantive examples of improved research responsive-' mess resulting fran Research Committee deliberations * The entire inhalable particles health affects research program, including the substances to be tested, the type of exposures to be assessed, and the timing of tests in the clinical and toxicological programs, has been restructured. The Agency's FY-80 Congressional budget submission will reflect these and other changes in the research program, jointly determined by the regulatory *offices and research staffs. In the words of William Drayton, EPA's Assistant Administrator for Planning and Management, before the House Subcommittee on the Environment and the Atmosphere (September 14, 1978), "Our initial pilot tests of this approach have quite successfully drawn the participants fran distant adversary roles into growing collaboration-" The completion of initial Research Strategy documents will certainly add to this growing collaboration. Drafts of the five Research Strategies have now been submitted by each committee and are being reviewed throughout the Agency. These strategies are expected, in final form, to include pro'- jections of the regulatory research needs of the program and regional `offices described with sufficlent precision to explain the formulation of `a responsive research program for three to five years into the future. `Upon completion of each Research Strategy, the Assistant Administrator for *Reh and Development and the Assistant Administrator, of the relevant `program office will submit the document to the Research Oversight Committee, `ccmposed of EPA's top managers, for approval. - PAGENO="0246" 240 Although we feel we have already taken major steps toward correcting identified deficiencies, we plan to continue to move ahead in the next year. With regard to the responsiveness of the rest of the research program, we intend to expand the Research Committee system to other areas. Although additional research planning units (committees) have not been officially designated, we have plans underway to expand the system from the approximately twentyfive percent of EPA's research covered by the five existing committees to a system encompassing over seventy percent of the research budget. There are several elements of our proposed system which have not yet been fully investigated. In our June 1978 report we suggested that we would give considerable attention to the development of a "Research Incentive System." The primary purpose would be "to establish a mechanism to encourage ORD to be responsive to Program and Regional needs." Addi-~ tionally, the system would: 1) further promote detailed mutual under- standing of missions and constraints by both program and research staff; 2) encourage further responsiveness by both groups to each other's needs; and 3) help assure satisfactory conduct and delivery of critical program support research. The five pilot Research Committees were unable to devote sufficient time to the development of such a mechanism in the initial stage of the program. We will examine the Research Incentive Systen, and other enhancements, over the next six to twelve months. PAGENO="0247" 241 We are taking two additional actions which should favorably impact the quality of EPA's research program. The first of these is an experiment in a "matrix" form of management. Under such a system, a manager is designated for an area of research which is not producing results which are timely or of adequate quality. Such a matrix manager is charged with coordinating and delivering all research results in the specified area, while the work is actually performed by the functional line unita. We have already begun a limited experiment with this potential management tool. The chairman of the Mobile Source Research Committee has been named as matrix manager for all mobile sources pollution research, especially the diesel particulate characterization and effects research discussed earlier. Re has been assigned to the staff office of the Assistant Administrator of ORD for 1~O days to plan and implement all research activities in this area. While we believe that the creation of matrix managers might be a partial solution to assuring quality implementation of research plans, we also feel that we need to expand our efforts to obtain systematic peer review. Toward that end we hope to more fully incorporate peer review mechanisms into the activities of Research Committees during the next six months. PAGENO="0248" 242 Another element of our revised research planning and management system which has not been fully implemented is our proposed Exploratory Research Committee. This Committee will be convened within the next several months. An issue to be dealt with is the adequacy of EPA's anticipatory research program. Mixed signals fran the Congress are causing some problems in for-P mulating an adequate, cohesive anticipatory research program. The Congress has encouraged us to expand our efforts in this area, but. has failed to support the President's initiative to enhance this research. Specifically, both the Senate Subcommittee on Resource Protection and the House Subcan- mittee on the Environment and Atmosphere have encouraged us to expand our anticipatory research efforts. The full Congress, however, reduced our FY 1979 budget request for these programs by $6 million. Despite thié diffi- culty, we believe the initiation of the program, though modest, represents a conceptual breakthrough behind which the entire Agency management team is united. Because the funding to date has been inadequate, we hope the Congress will reaffirm its support for an expansion of the program as a key element within the research program. In summary, then, the revised planning and management system described in the June 1978 report to the Congress has encouraged the research and regulatory program staffs of EPA to become more responsive to their mutual needs. Although the revised system has not been fully implemented, we feel that the Research Committee resuits are sufficiently encouraging to warrant expansion of the system, and to continue our evaluation during the caning months. PAGENO="0249" RESPIRABLE PARTICULATES RESEARCH COMMITTEE MEMBERSHIP MEMBERS ROGER CORTESI, CHAIRMAN JAMES ABBOT PAUL ALTSCHULLER* JOHN BACHMAN FRANK BIROS FRANZ BURMANN ELISSA FELDMAN, PILOT COORDINATOR ROBERT LEE ART SPRATLIN PAUL STOLPMAN DEBORAH TAYLOR JAMES WEIGOLD ORGANIZATION OFFICE OF HEALTH AND ECOLOGICAL EFFECTS/ORD INDUSTRIAL ENVIRONMENTAL RESEARCH LABIORD/RTP ENVIRONMENTAL SCIENCES RESEARCH LAB/ORD/RTP * OFFICE OF AiR QUALITY PLANNING AND STANDARDSIOAWM/RTP OFFICE OF GENERAL ENFORCEMENT/OE/HQ - ENVIRONMENTAL SCIENCE RESEARCH LAB/ORD/RTP OFFICE OF RESEARCH PROGRAM MANAGEMENT/ORD HEALTH EFFECTS RESEARCH LAB/QRDIRTP AIR BRANCH/REGION VII OFFICE OF PROGRAM MANAGEMENT OPERATIONSIOAWM OFFICE OF PROGRAM EVALUATION/OPMIHQ OFFICE Of AiR QUALITY PLANNING~AND STANDARDS/OAWM/RTP PAGENO="0250" MEMBERS DRINKING VVATER RESEARCH COMMITTEE_MEMBERSHIP ORGANIZATION GORDON ROBECK, CHAIRMAN. ROBERT BOOTH JOE COTRUVO' WM. DONALDSON NM. GALAGER EDGELDREICH -lEND GORCHEV EDHOCKMAN VICTOR KIMM `\RNIE KUZMACK ~L LEVIN JEANIE LOVING, PILOT COORDINATOR )ON MADDOX McCABE ~OM MURPHY IOMPADDEN 3ILL ROSENBERG ~OM STANLEY JIM SYMONS \LVAROYAMHURE MUNICIPAL ENVIRONMENTAL RESEARCH LAB/ORD ENVIRONMENTAL MON1TORING AND SUPPORT LAB/ORD CRITERIA AND STANDARDS DIVISION/ODW ENVIRONMENTAL RESEARCH CENTER, ATHENS/ORQ ROBERT S. KERR RESEARCH LAB/ORD MUNICIPAL ENVIRONMENTAL RESEARCH LAB/ORD HEALTH EFFECTS DIVISION/ORD GROUNDWATER PROTECTION BRANCH/ODW OFFICE OF DR1N KING WATER (ODW)/OWHM OFFICE OF PROGRAM DEV, ANDE VALUATION STATE PROGRAMS DIVISION OFFICE OF RESEARCH PROGRAM MANAGEMENT/ORO .*~` REGION V1,WATER SUPPLY BRANCH HEALTH EFFECTS RESEARCH LAB/ORD OFFICE OF AIR, LAND AND WATER USE/ORD WASTE MANAGEMENT DIVISION/ORD OFFICE OF PLANNING AND MANAGEMENT OFFICE OF MONITORING AND TECHNICAL SUPPORT/ORO MUNICIPAL ENVIRONMENTAL RESEARCH LAB/ORD OFFICE OF ENFORCEMENT PAGENO="0251" INDUSTRIAL WASTEVVATER CONTROL RESEARCH COMMITTEE MEMBERSHIP MEMBERS DAVE G. STEPHAN, CHAIRMAN ROBERT SCHAFFER ,` CARL SCHAFER DONALD EHRETH Et.AINE FITZBACK, PILOT CqORDINATOR KEN I-IUFFMAN RALPH BLACK MAVIS BRAVO RO8ERTM~DZ ORGANIZATION , INDUSTRIAL ENVIRONMENTAL RESEARCH LAB.CI/ORD EFFLUENT 9PIDELINES DIVISION/OWHM OFFICE OF ENERGY, MINERALS AND INDUSTRY/ORD OFFICE OF AIR; LAND, AND WATER USE/ORD OFFICE OF RESEARCH PROGRAM MANAGEMENT/ORD REGION VI `~ OFF ICE OF SOLID WASTE/OAWM STANDARDS AND REGULATORY EVALUATIO1~J DI VISION! .OPM " OF!JCL OF MQN1TQRING AND TgC1INICAI. $UPPQRT1ORD OFFICE OF ENFORCEMENT HARRY THRON PAGENO="0252" MEMBERS FRANK PRINCIOTTA, CHAIRMAN STAN BLACKEJI *1 RON BRADOW DICK BR ICELAND FRANK BURMANN ELISSA FELDMAN, P1 LOT'COORDINATOR CHARLES GRAY BEN JACKSON KURT JAKOBSON CHRIS KIRTZ GEORGE KITTREDGE DUKE MOORE 1306 PAPETTI LANCE WALLACE ORGANIZATION OFFICE OF ENERGY MINERALS AND INDUSTRY/ORD OFFiCE OF HEALTH AND ECOLOGICAL EFFECTS/ORD . f'~ ENVIRONMENTAL SCIENCES RESEARCH LABORATORY/ORD OAWM EN VIRONMENTAL MONITORING SUPPORT LABORATORY/ORD/RTP OFFICE OF RESEARCH PROGRAM MANAGEMENT/ORD OMSAPC/ECTD (A~ : OFFICE pF ENFORCEMENT OFFiCE QF ENERGY, MINERALS AND INDU~TRY/ORD SPED/OPM OMSAPC/OAWM. HEALTH EFFECTS RESEARCH LABORATORY/ORD/CIN OFFICE AIR, LAND AND WATER USE/ORD OFFICE OF M0NITORIN~ AND TECHNICAl. SUPPORT V... MOBILE SOURCE RESEARCH COMMITTEE MEMBERSHIP PAGENO="0253" ORGANIZATION GULF BREEZE ENVIRONMENTAL RESEARCH LAB/ORD HEALTH EFFECTS DIVISION/ORD OFFICE OF PESTICIDES PROGRAM/OTS HEALTH EFFECTS RESEARCH LAB (RTP)/ORD ENVIRONMENTAL RESEARCH LAB (ATHENS)/ORD OFFiCE OF ENFORCEMENT STANDARDS AN~ REGULATORY EVALUATION DIVISION/OPM MONITORING TECHNOLOGY DIV1S1ON/OPM PESTICIDES BRANCH/REGION I MEDIA QUALITY MANAGEMENT DIV.IORD OFFICE OF RESEARCH PROGRAM MANAGEMENT/ORD PESTICIDES RESEARCH COMMITTEE MEMBERSHIP MEMBERS TOM DUKE, CHAIRMAN GEORGE ARMSTRONG *` MIKE CONLON BILL DURHAM DAVE DUTTWEILLER' PHYLLIS FLAHERTY ALAN JENN1NGS BOB MEDZ DAN MIAELLO COURTNEY RIODAN DENISE SWINK, PILOT COORDINATOR PAGENO="0254" 248 APPENDIX 3. GARDEN STATE PAPERCOMPANY, INC. 2020 NORTH FOURTEENTH STREET. ARLINGTON. VIRGINIA. 22201/TELEPHONE (703) 528~8444 March 27, 1979 The Honorable Jerome A. Ambro, Chairman Subcommittee on Natural Resources and Environment Committee on Science and Technology Washington, D. C. 20515 Dear Mr. Chairman: We have read with a great deal of interest House Committee on Science and Technology Report No. 96-58 on H. R. 2676, "Authorizing Fiscal Year 1980 Appropriations to the Office of Research and Develop- ment, Environmental Protection Agency." We note particularly the discussion of the solid waste program, Section 2(a)(15) Solid Waste/Public Sector Activities. The Committee notes that EPA .. . "has already shifted some resources away from waste management activities and into hazardous waste activities." The Com- mittee notes also that "There is concern, however, that a proper balance be struck between the hazardous waste and municipal waste management/resource recovery activities of the program." We share this concern and have so testified before the Senate Sub- committee on Resource Protection and the House Subcommittee on Trans- portation and Commerce. We have expressed concern also about the threat to the availability of sourue separated recyclable materials by what is per- ceived to be a headlong rush to adopt urban waste disposal programs that are weighted heavily in favor of energy recovery. We are concerned that energy recovery only emphasis denies consideration of a comprehensive balanced approach to resource recovery; that such an approach ignores the compatibility of source separated materials/energy recovery systems and the energy conserva- tion potential of recycled waste materials recovered through source separation. These concerns are shared also by other member companies of the American Paper Institute, and member companies of the Can Manufacturers Institute and the Glass Packaging Institute. A review of the position of these organizations on the importance of recognizing the resource recovery value and potential of source separated recyclable materials Is contained In a land- mark Joint statement dated March 12, 1979. A copy of this statement together SUBSIDIARY OF MEDIA GENERAL. INC.. RICHMOND. VIRGINIA PAGENO="0255" 249 The Honorable Jerome A. Ambro Page Two March 27, 1979 with a copy of the testimony of the Garden State Paper Company, noted above, accompanies this Letter. Mr. Chairman, we are particularly gratified by the Committee's obser- vatioa about the yet to be implemented important mission of the Department of Commerce under the Resource Conservation and Recovery Act. The Committee wisely recognizes that the development of markets for recovered materials is basic to the achievement of the materials recovery objectives of the law. You will note that we endorse this judgment wholeheartedly. We have recommended, in our testimony, that the DepartmentO~ Commerce be given specific authority, in the reauthorization bill, to seek appropriations for carrying out its important mandate under the law. We believe that an effective Department of Commerce effort in carrying out its market assessment functions can enhance the practicality and economic viability of urban resource recovery projects of both the Department of Energy and the Environmental Protection Agency. We believe that the activation of the Subtitle E functions of the Department are essential to developing a balanced materialsknergy approach for the achievement of the resource recovery objectives of the law. We urge the Committee to support our recommendations concerning the activation of the Department of Commerce's functions pursuant to Subtitle E of Public Law 94-580. We would be pleased to answer any questions or provide further Infor- mation on any of the matters discussed in this letter. Sincerely, Basil Snider, Jr. f President BS,Jr. Imp Enclosures CC: Honorable Don Fuqua, Chairman Committee on Science and Technology PAGENO="0256" 250 APPENDIx 4. Report of the Health Effects Research Review Group U.S. Environmental Protection Agency ~ Science Advisory Board February 1979 \~~I ~ PRO~ PAGENO="0257" 251 EPA NOTICE This report has been written as a part of the activities of the Agency's Science Advisory Board, a public advisory group providing extramural scientific information to the Admin- istrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency, and hence its contents do not necessarily represent the views and policies of the Environmental Protection Agency. `43-778 0 - 79 - 17 PAGENO="0258" 252 TABLE OF CONTENTS Page I. Introduction 4 II. Summary and Recommendations 6 A. Summary 6 B. Recommendations 8 III. Committee Membership, Approaches, and Procedures 14 A. Committee Membership 14 B. Approach to the Assessment of R&D and Procedures Utilized 14 IV. Research in a Regulatory Agency: The Conflict Defined.... 17 A. Present and Future Agency Needs for Data 17 B. Investigatory Time Frames 18 C. Investigator and Program Staff Interactions 18 D. Evaluating the Responsiveness of ORD 19 £. What is an Investigatory Product in a Regulatory Agency 21 V. Observations of Current EPA Research and Development 22 A. Identification of Research Needs 22 B. Planning the Research Program 24 1. Budget Formulation 24 2. Research Program Formulation 25 3. Pre-project Evaluation of Productivity and Costs 26 4. Good and Poor Planning 26 C. Performance of Research 28 1. Adequacy of Facilities for Research 28 2. Staffing for Research 29 3. Accountability for Expenditures 30 D. The Quality of Health Effects Research 31 1. Publication and Reporting of Research Results.... 32 2. Quality Assurance in Grants and Contracts 33 3. Career Opportunities 36 4. Other Components of Quality Assurance 36 5. Interagency Agreements 37 E. Other Relevant Topics 38 1. Long-range, or Core, Research 38 2. ORD/Congressional Staff Information Transfer 38 VI. Utilization of ORD Results 39 VII. Status of Implementation of Two Sets of National Academy of Sclences(NAS) Recommendations to EPA 40 A. Recommendations from the Environmental Research Assessment Committee of 1975 40 B. Recommendations of the Review Committee on Management of EPA's Research and Development Activities 44 PAGENO="0259" 253 page VIII. Community Health and Environmental Surveillance System (CHESS): An Investigative Report 55 A. Background of the CHESS Program 55 B. Findings of the Subgroup 56 C. Steps Taken by EPA to Meet Brown Committee Recommendations 57 APPENDICES A. Charge to Committee and Authorization for Charge in Public Law 95-155 A-i B. Committee Membership and Consultants A-9 C. Chronology of Committee Visits to Facilities and Meetings A-ll D. List of Principals Interviewed and/or Supplying Information A-13 E. Agenda of Major Regulations Being Considered by EPA. * A.-29 PAGENO="0260" 254 I. INTRODUCTION The Congress required an evaluation of the health effects research efforts of the U.S. Environmental Protection Agency in section 8(d) of Public Law 95-155, enacted November 8, 1977.* Subsequent to the passage of the Act, EPA's Science Advisory Board formed a special committee to perform the mandated evaluation. This Committee, named the Health Effects Research Review Group (HERRG) and composed of experienced scientists and research managers, began their task in May 1978. The Act stated that the evaluation include the following: 1) The health effects research authorized by this Act and other laws; 2) The procedures generally used in the conduct of such research; 3) The internal and external reporting of the results of such research; 4) The review procedures for such research and resul ts; 5) The procedures by which such results are used in internal and external recommendations on policy, regulations, and legislation; and 6) The findings and recommendations of the report to the House Committee on Science and Technology entitled "The Environmental Protection Agency's Research Program with Primary Emphasis on the Community Health and Environmental Surveillance System (CHESS): An Investigative Report." The Act further stated that "the review shall focus special attention on the procedural safegards required to preserve the scien- tific integrity of such research and to insure reporting and use of the results of such research in subsequent recommendations. The report shall include specific recommendations on the results of the review to ensure scientific integrity throughout the Agency's health effects research, review, reporting, and recommendation process." The word "research" takes on a broad meaning in a regula- tory agency. For the purpose of this evaluation, health effects research will be defined as requested by Mr. Costle in his letter of June 17, 1978, to the Chairman of the Science Advisory Board. A quotation from that letter follows. - *Section 8(d) of this Act requires that a special evaluation of EPA's health effects research be prepared by the Science Advisory Board (SAB) and the report be submitted to the Administrator, the President and the Congress. 4 PAGENO="0261" 255 "To delineate the Congress' charge more sharply, I urge the Study Group to define health effects research to include all planned activities, collection and analyses of data done within the Agency for the purpose of adding to the scientific basis for understanding the effects of environmental factors on human health. This definition would include those activities within the Agency which may be used to assess human risk, and which support standard setting and regulatory deci- sion and any activity which gathers new knowledge about human health, or improves our understanding of human health either directly or which can be used to extrapolate to human health impacts." In view of the limited time available to the Committee, this study focused on the collection and analysis of data primarily to add new knowledg~. The analysis of existing information and dita, which already satisfies generally acceptable criteria for scientific adequacy, was not considered to be within the scope of the charge to the Committee. Some requested data were unavailable or not provided to the Committee, therefOre,the evaluation is not as complete as initially anticipated or desired. 5 PAGENO="0262" 256 II. SUMMARY AND RECOMMENDATIONS A. Summary The purpose of this report is to summarize the nature of health effects research in a regulatory agency, to describe the current status of that function in EPA, and to present conclu- sions and recommendations. Supporting data and reports relating to individual ORD facilities are available but are not included. The Committee visited (either as a full or partial committee) all EPA laboratories performing health effects research. Interviews were conducted with senior laboratory staff, managers, and bench scientists as well as with senior managers in the Office of Research and Development (ORD) and in the Program Offices. For the purposes of this report, a "Program Office" refers mainly to the Offices of Water and Waste Management; Air, Noise, and Radiation; and Toxic Substances, as these are the offices responsible for developing regulations and setting standards or tolerances in response to specific legislative acts. A list of the facilities visited, Committee members visiting each facility, and those EPA employees interviewed or providing information can be found in Appendices C and D. The Committee also utilized the services of SAB members, other scientists, and research managers on an ad hoc basis (Appendix B). Programs and facilities were evaluated using a number of criteria relating to the objectives of the research and the quality of facilities, staff and results. Among these criteria were responsiveness of the research function, research influence in the decision making process, coherence of planning and goal-setting between ORD and the Program Offices, and quality assurance through peer review and publications. The Committee interviewed many competent and dedicated people with a real desire to work in a more effective, efficient and involved way. Research and development in a regulatory agency is a complex task, one requiring research targeted to regulatory requirements usually having short (six month to two year) time frames. Research and development must be related to specific regulatory needs. Identification of gaps in data and needed research effort necessitates cooperative planning between 6 PAGENO="0263" 257 program managers*, often unfamiliar with research, and research managers, who are often insensitive to regulatory pressures and requirements. Researchers, as professionals, may have difficulty in identifying results which will satisfy regulatory needs when these results are not in their scientific specialties. Constantly altering budgetary allocations to adapt to rapidly changing regulatory needs aggravates research- program staff relations. For these and other reasons, ORD has frequently been viewed as unresponsive by many program managers, who do not, in general, depend Upon ORD to support their regulatory efforts. The Committee concluded that it would require far greater joint planning and coordination of ORD and Program Office staffs if ORD outputs, useful to regulation, were to be commensurate with the funds allocated. At present, it is not an effective or an efficient system. The dilemma of research in a regulatory agency is further treated in Chapter IV. The most successful and useful research programs were found where there was a close working relationship and understanding between scientists in the laboratories and their counterparts in the Program Offices. Such communications are essential to an understanding of priorities, quality demands, timing and what was truly needed to back up the regulatory process in the short and long terms. Poor results were seen all too often, however, because cl6se relationships did not exist. - Pilot research committees have helped to establish essential communications between those who have direct and indirect responsibilities. Where successful, the resulting agreements, e.g., Drinking Water and Pesticides, have helped to make research more responsive and have cut across juris- dictional barriers to establish objectives, goals and plans. The pilot research committees are one means to an end, but shorter and more direct communications lines are needed between data generators and data users. Beyond a committee approach, there seemed to be little consideration of organizational structures designed to streamline decision making. Hopelessness was expressed many times by those concerned when faced with the seemingly obdurate character of the civil service system and the highly placed, inflexible, and sometimes less than adequate individuals who occupy unessential positions. Inflexibility makes it difficult, indeed, to place people properly. and to transfer or get rid of people not performing up to expectations in their jobs. - *A program manager is defined as that person in the Program Office who is responsible for developing the regulatory or standard-setting activity for a specific program as mandated by legislation. A research manager is that person in ORD who is responsible for formulating, planning, and executing specific research programs. PAGENO="0264" 258 Recent changes in the civil service laws were not seen as adequate to effect much improvement. Desirable changes can occur, but they will require enormous effort, training in, and application of the principles of management by objective and job performance evaluation to establish a clear understanding, of what is expected of each employee. B. Recommendations The Committee recommends that: (1) ORD and Program Office leadership take immediate steps to coordinate all research planning and activities in the Agency. Joint planning to identify information needs must begin as soon as a decision is reached to prepare a regulatory proposal. Immediately following a program decision to develop a regulatory proposal, Program Office and ORD staff should be assigned to review existing information needs. This group should be given authority to organize Program Office-ORD staff to identify regulatory needs for specific proposals and outline the required research to fill the gaps. (2) ORD continue to use - appropriate research committees, but they should no.t be ORD's exclusive planning mechanism. Research committees, initiated on a pilot scale in 1978 to help ORD plan and coordinate its research activities with the Program Offices, should be used sparingly. These research committees, really task forces, will be most useful when research needs relate to multiple Program Offices and laboratories. The research committees should be used for identification and prioritization of needs. These committees should not be involved with research implementation. Key managers within ORD should devise mechanisms to develop well understood objectives, goals, plans and measures of performance for how r~esearch should be conducted. The Committee does not believe that it will be possible for ORD to fulfill its function without extensive agreement by key personnel on objectives, goals, plans, and measures of performance. It might be helpful for ORD to hire experienced management specialists, as consultants, to help address some of the difficult managerial problems which currently exist. 8 PAGENO="0265" 259 ORD leadership must take steps as soon as possible to work out an understanding with Assistant Administrators in the Program Offices to simplify and shorten lines of communication and to cut to a minimum the reprocessing of decisions by the Washington ORD staff. (3) The scientific staff of ORD identify subject areas and establish active investigatory groups to pursue long term research essential to regulatory needs. (Implementation of recommendation 1 will ensure that long term research efforts remain relevant.) S There should be a long-term ORD investment in researchers and facilities to develop highly active and productive groups in those research areas which are central to large segments' of the Agency's regulatory activity. Allocation of a specific percentage, at least 10%, of the ORD budget for relevant research in case subject areas seems to be reasonable. (4) The incorporation of ORD research results into criteria, standards, and regulations be strengthened. ORD must stress, at all levels, the importance of producing results and assisting with their incorporation into regulations and standards. ORD has neither fully recognized or accepted this criterion for judging its efficiency, nor developed mechanisms for efficient utilization of research results by Program Offices. ORD does not maintain records of results which have been incorporated into regulations. The formation of the Environmental Assessment Groups is a step in the right direction. Part of the responsibility of - these groups should be the documenting of which research results have been utilized, the continuing audit of the usefulness of ORD results to regulations and standard setting, and getting feedback from the Program Offices about the research and research planning activities. The Committee found the model, outlined on page 9 of Volume III of "Research and Development in the Environmental Protection Agency," to be still relevant for Agency use. (5) Responsibility and authority for implementation of research and reporting of research be vested in the laboratory directors and the staff scientists, after agreement on research plans. 9 PAGENO="0266" 260 The Committee feels that too many specific directions regarding research implementation come from headquarters. This prevents the scientists from using their talents and diminishes the scientific climate for *innovative research. (6) After agreement on responsibilities for research implementation, laboratory directors and their scientific staff be permitted to performed their assigned tasks. (See recommendation 5.) Laboratory staff need protection against unwarranted mandates, incursions into allotted time for research, and reorganizations and spurious changes in policies that occur with the all-too-frequent changes in leadership. The scientists also need a sense of the Agency's long range commitment to its stated goals. (7) An expansion of the Interagency Regulatory Group (IRLG) activities be carried out. The excellent planning initiatives of IRLG should be extended to include environmental health research. The IRLG is seen as an excellent beginning with the potential of reducing duplication and confusion among agencies. This effort should be extended to strengthen coordination of research planning by all agencies conducting environmental health research. (8) A simple, easily under- stood accounting system be established for planning, assigning and monitoring use of funds and personnel relative to ORD's intramural and extramural programs. Effective use of 1imited funds and personnel requires that they be carefully managed. The accounting systems now in use are inadequate. At the present time, analyses are not performed to place in perspective salaries, equipment costs, services, etc. Those cost breakdowns are necessary to give ORD information about responsive and nonresponsive work at the different laboratories performing health effects rese~arch. (9) Standard procedures for awarding contracts, grants, and cooperative agreements, and monitoring extramural research be simplified and enforced. 10 PAGENO="0267" 261 Current elaborate rules for contract and grant awards should be reviewed and revised to promote efficiency and timeliness of extramural awards. All personnel must adhere to these new procedures. This would end the current abuses of the extramural award system. Procedures should be adopted to ensure adherence to the new requirements after revisions are made. The monitoring procedures should indicate methods for evaluating the performance of contractors and grantees during and after completion of their work. Furthermore, the extramural research results should be published in peer reviewed scientific journals. EPA-published reports are no substitute for open literature publications. Adequate travel funds should be allocated for proper site visits and for monitoring of extramural work. Presently, there is no routine, operational audit of the quality of extramural research. Responsibility for extramural research (planning, awards, and monitoring) should be made according to the staff's capabilities to effectively plan and monitor such research. This should take into account the amount of independent in-house research expected from the staff scientists. Extramural monitoring assignments should only be made to scientists who have demonstrated professional competence and are thoroughly familiar with how research is conducted in the field being monitored. (10) Scientific peer review of proposals, programs, and intramural and extramural research be greatly intensified. Scientific credibility and defensibility of research done in support of regulations are key elements of the success and acceptance of the Agency's role by the public. The Committee feels that, to the maximum extent practical, scientific peer review mechanisms should be utilized to improve the quality of final research results. All programs and organizational units should be periodically subjected to peer review by qualified scientists from outside the Agency. All proposals and completed research should be reviewed by peer scientists within the Agency, and representative items should be reviewed by scientists outside the Agency. The quality of research in EPA is Important not only because anyresearch should meet standards acceptable to the scientific community but also for reasons derived from the regulatory nature of the Agency. 11 PAGENO="0268" 262 To ensure acceptability of research results, the studies must be reviewed by one's scientific peers and published in reputable scientific journals. Failure to so treat results of research investigations involves the risk that review will occur at a later date, in a adversary situation, with possible refutation of results and embarrassment to the Agency. (11) A dual-ladder promotional system be implemented for qualified scientists to advance in grade and salary without having to undertake supervisory or managerial responsibilities. Presently EPA has a promotion ladder inadequate to allow * scientists to remain in the laboratory and be promoted strictly on the basis of their scientific excellence. EPA suffers from a poor reputation as far as the scientific quality of its health effects research is concerned. This reputation is not totally deserved. There does need to be a system whereby both qualified scientists and qualified managers can each advance and be rewarded in their own fields. Well qualified personnel are the key ingredient to the conduct of a scientifically sound research program. At the present time, there are both formal and informal procedures that encourage scientists seeking promotions to accept supervisory and administrative responsibilities, thereby reducing the amount of time they have to spend on laboratory research. When personnel are assigned to senior management positions, primary consideration should be given to individuals who have demonstrated scientific and managerial capabilities; an understanding of how research is planned, conducted and reported; and the ability to communicate research information and needs to both scientists and non-scientists. (12) Research management give immediate attention to instituting, in the laboratories, a variety of procedures to create an atmosphere conducive to scientific excellence. Even though the laboratories are located on Or near university campuses or other research institutions, EPA scientists were somewhat outside the mainstream of scientific ~events. The Committee, therefore, urges management to regularly schedule seminars in which both outside scientists and Agency scientists participate, invite outside scientists to spend time in EPA laboratories (in addition to use of the Interagency Personnel Agreement--IPAs), encourage EPA scientists to spend time in outside laboratories (an exchange program), sponsor workshops and symposia, and generally institute a closer interaction with geographically close institutions. 12 PAGENO="0269" 263 (13) ORD and senior Program Office staff rotate assignments, preferably on the basis of those ORD and Progam organizational units which consistently interact. It is essential for effective performance that Program Office and ORD managers understand the problems and capabilities in each organization. Program managers are often unfamiliar with research planning, laboratory work and the inherent time constraints. Likewise, research managers are often unaware and insensitive to regulatory pressures and requirements and with the dilemma of how to present data in a form useful to the Programs. (14) The research program using the clinical inhalation exposure facility at Chapel Hill, North Carolina, be fully staffed and a sound research program implemented as soon as possible. The clinical inhalation facility at Chapel Hill is a unique facility, engineered to deliver the desired exposure levels; however, the scientific program, staffing, and plans to utilize the facility are totally ipadequate--a very conspicuous waste, as it now stands. ORD should immediately assess the future need for and use of this facility, establish goals and support for the facility, and assure that the facility is not wasted--even if EPA has to make it available to outside groups.. This facility was designed for long range studies to accurately assess and predict the potential adverse effects of selected environmental chemical agents. The inhalation program, once developed, should be scientifically peer reviewed and approved. 13 PAGENO="0270" 264 III. COMMITTEE MEMBERSHIP, APPROACHES AND PROCEDURES A. Committee Membership The Health Effects Research Review Group (HERRG) consisted of core members and consultants selected for their scientific expertise and research management skills. The consultants supplemented core members and were used to provide specific expertise for the evaluation of individual laboratory programs or special topics of research. A list of Committee members and consultants is Appendix B. B. ~pproach to the Assessment of R&D and Procedures Used It was apparent from the outset that the Committee needed a clear understanding of the mission of health effects research as seen from the viewpoints of the personnel in both the various Program Offices and ORD. Responsiveness of the research function to the pressing (often mandated) needs of the Program Offices has been inadequate in the past; this problem has been clearly described in a report by a committee of the National Academy of Sciences, Analytical Studies of the U.S. Environmental Protection Agency, ~1olume III: "Research and Development in the Environmental Prote~i~1on Agency,' 1977. Of necessity, the Committee had to subdivide much of its investigation into small study group activities. A common approach was taken to make it easier to analyze and assemble the findings of the various study groups into an integrated final report. Thus, the research function of the Agency was to be analysed inthe context of the regulatory responsibilities of the A9enç~~hich in turn requfres a reliible and defensible data base for decision making. The Committee agreed that research can only be understood if the reciprocal relationship between the users of the information (the Program Offices) and the generators of the information (ORD) was examined. The perceptions of both~the generators and the users were, therefore, to be probed to determine if there were shared goals and a shared understanding of what is known, what is un1~ñown, and whatThiids to be known. It was also necessary to determine whether there was a shared understanding of the time frame necessary to generate or~ssemble the needed data. These perceptions were to be examined at several hierarchical levels to determine if the intentions of the supervisors were accepted in a way that motivated the respective organizational units regardless of location or attitudinal preferences. While conducting interviews and fact-finding sessions, Committee members tried to use some of the following checkpoints as they were appropriate for the various situa-tions. These points were the basis for the formulation of this report. 14 PAGENO="0271" 265 a. Checkpoints relating to the mission of health- related research as i't supports short-term and long-term Agency needs: 1. Responsiveness of the research function (as defined at the outset) 2. Sense of urgency and commitment of the research function 3. Research influence on, judgments made on the decision making process (level of influence and dependence by the program offices) 4. Coherence of planning and goal setting be-. tween the Program Offices and ORD (Are budgets really reconciled and supported by both' the Program Oflices and ORD?) 5. Examples of good and poor responses by ORD 6. How and by whom is the decision made to initiate and conduct specific research investigations? 7. How are information gaps i~dentified? How are long-term trends with potential environmental, impacts identified? How are long-term research needs defined and planned to assure budgetary support? 8. Beyond the Program Offices and the ORD functional organizations, what other factors help influence what research is to be, done? b. Checkpoints relating to the gualit~ of health effects research as It supports short-term and long-term Agency needs: 1. Quality assurance; a) Good laboratory practices b) How is quality assurance implemented to Improve the defensibility of results? c) Evidence of attention to detail and carefulness (facilities, work flow, housekeeping, attitude, safety program) d) Personal.. scientific integrity, including quality of planning and experimental design, rigor of analysis, courage to disprove one's hypotheses (or hypotheses of a superior), and acceptance of opinions of qualified peers e) Can the most qualified people be quickly identified? f) Is the civil service system seen as a positive factor in the encouragement of a good research program within EPA? 15 PAGENO="0272" 266 2. Publication of results (reporting) a) In journals requiring scientific peer review, internal government publications, journals or meetings not requiring scientific peer review b) Methods for approving manuscripts before release or publication c) Is publication seen as helpful to career development? With these checkpoints in mind, the Committee conducted its assessment through a series of fact-finding sessions and public meetings in Washington and in various EPA laboratories (see Appendix C). The Committee chairman and co-chairman first discussed the charge and the plans for accomplishing the evaluation with the appropriate Congressmen and their staffs. Subsequently, the Committee met with the Administrator, the Assistant Administrators and other senior EPA policy and management staff in various Program Offices, and with representatives from the regions, laboratory directors, senior science managers, and individual laboratory scientists (Appendix 0). The Committee ~members reviewed legislative mandates, various EPA documents, and other papers and memoranda relating to the Committee's charge. 16 PAGENO="0273" 267 IV. RESEARCH IN A REGULATORY AGENCY: THE CONFLICT DEFINED A. Present and Future Agency Needs for Data Volumes have been written on regulatory agency research needs in general and on EPA research needs in particular. Therefore, the Coa~mittee approached the subject of the research and development needs of EPA with trepidation and elected initially to describe the pressures and constraints imposed generally upon a research and development group in a regulatory agency and those imposed upon EPA in particular. Program administrators in regulatory agencies are captives of the calendar deadlines imposed for regulation by the specific statutes they enforce. These agencies routinely deal with Congress, irate constituents, citizen groups, the media, and others. The professional skills which contribute to their success and/or survival are all devoted to integrating immediate pressures and existing knowledge into a set of regulations acceptable to all. This is a difficult situation, one requiring sensitivity to human behavior and appreciation for the relevant available data base. Regulations are usually compromises, their political socio-economic impact and whether they can be enforced. The scientific and technical bases for a regulation will be put to rigorous test if, and only if, the regulation is challenged. Judicial review will incorporate and consider all relevant data; an administrative "gamble" made in the absence of sufficient data to support regulation will very likely lead to remanding the rule to the Agency. Development, promulgation and enforcement of regulations, particularly in an area as underdeveloped and evolutionary as environment, is a difficult exercise. The formal challenges to regulation are cyclical. Because of inflationary pressures on regulatees since 1976, there has been an increasing trend toward challenging environmental regulatory promulgations. The courts have been sympathetic to the innovative promulgations of EPA, but the economic impacts of EPA administrative interpretations of enabling statutes have led to regulatee demands for more complete substantiating data for promulgated rules; those demands will increase in the future. Even those sympathetic to prudent Federal environmental regulations are demanding higher standards of proof during this highly inflationary period of increasingly demanding and varied Federal regulation. Because environmental rules are still perceived by many as a luxury affordable only by a prosperous private sector, EPA must anticipate continuous, more sophisticated private sector challenges because of inflationary pressures. 17 ~t3-778 0 - 79 - 18 PAGENO="0274" 268 These challenges will be overcome only by convincing arguments for regulation, arguments drawing upon defensible data. These data will have to relate specifically to improvements in human health if EPA is to fulfill its mandate as an Agency. In the future EPA will increasingly have to document health gains anticipated from allocation and expenditure of large sums of money for regulation and control of environmental pollution. B. Investigatory Time Frames Specific statutes include timetables for regulation assigned by Congress. The Agency has formulated~a table of regulations scheduled or in progress (Appendix E). Program administrators will formulate these regulations with whatever data are available prior to and until the scheduled completion date. In general, schedules for EPA to write regulations are short; 6-12 months is normal, while 18 months is considered long. These are short time frames for generation of new information in the laboratory or in the field. EPA Research and Development Office (ORD) personnel have had enormous difficulty responding within the time allotted. It is essential that ORD and Program Office personnel carefully evaluate information needs critical to implementation of scheduled regulations. This must be done as soon as a statute is assigned to EPA for enforcement. In this way, ORD will be able to utilize the maximum available time to generate needed data for regulation. We did not perceive that research needs are routinely approached in this manner. C. Investigator and Program Staff Interactions *The perceived needs of program managers are usually very specific and often conflict with needs perceived by researchers. For example, researchers may regard experiments requiring toxicity data from animal exposure to pollutant agents at concentrations far in excess of those likely to occur under normal exposure as of little relevance to scientific understanding. Program personnel, however, may regard demonstrated toxicity data, even at unrealistically high exposure levels, as a rationale for regulation. Sorting out these differing perceptions requires personal interchange if ORD is to respond in a timely and meaningful manner. Too often in the past the Program Offices have perceived ORD as unresponsive because results were of a kind different from what had been anticipated and because research time frames were too long to allow the Program Offices to use the data produced. Under these circumstances, program administrators did not look to ORD for solutions to their problems. 18 PAGENO="0275" 269 Principal Program Office and ORD administrators are located in Washington, D.C. ORD investigators are located in laboratory facilities throughout the nation. Specific administrative mechanisms are required to ensure that communications occur between Program Office administrators and ORD investigators as research in support of specific regulations progresses. In 1978 five research committees were initiated on a pilot basis to help ORD plan and coordinate its research activities and become more responsive to the needs of designated Program Offices. These pilot research committees have helped to provide an essential communication function; furthermore, they have helped to establish understanding and commitment to objectives, goals, and plans. Carefully selected research committees are seen as a means to an end, although a cumbersome one, because their meetings help to educate those who need to know. In the long run, however, the functions served by the pilot research committees need to be institutionalized so that laboratory directors are not excluded from key roles in leadership or from maintaining a high level of competence in their respective laboratories. Program administrators frequently have their primary training in the legal or engineering professions; they are often not familiar with the state-of-the-art of ORD scientific research. ORD utilizes scientifically trained personnel at all levels of the organization, those working at science on a daily basis. One can draw flow diagrams of the decision making processes in a regulatory agency, diagrams illustrating ORD and Program Office personnel interactions. However, in the final analysis, exchange of information and resolution of issues is required of persons with essentially different bases of understanding. There will be a major built-in obstacle to communications between ORD and Programs Offices as long as ORD relies entirely on scientific managers and the Program Offices on managers who pride themselves on their pragmatic approach, managers grounded in law and/or engineering sciences. By one mechanism or another (rotation of assignments, creation of new positions for complementary professionals in each Program Office and ORD), there must be promotion of ORD-Program Office communication by ensuring that senior managers have a common language(s). D. Evaluating the Responsiveness of ORD The responsiveness of ORD is judged by a variety of groups and individuals, including EPA program managers, Congress, citizen groups, and the media, to name a few. The Committee probed primarily EPA program managers perceptions of ORD's responsiveness to their needs. Senior program managers have indicated that there hdve been recent improvements, butmuch 19 PAGENO="0276" 270 remains to be done. In the past,many Program Offices did not participate in ORD planning. Recent joint ORD-Program Office research planning exercises, such as the pilot research committees, have caused Program Offices to be more favorably disposed toward ORD activities. Ultimately, ORD's response to the Program Offices will be more stringently judged by how effectively the research results meet the specific needs of the regulators in a timely and scientifically rigorous fashion. The current auspicious climate for ORD pilot research committee planning must not be confused with future ORD outputs necessary to satisfy hard-pressed Agency program managers. For this reason, the major ingredients of ORD research that would allow ORD to be considered "responsive" to regulatory program needs will be briefly discussed. Following this discussion will be comments on the current EPA research process from the planning stages to the final utilization of results by Agency Program Office staffs. The timing of the delivery of research results to a Program Office is a major factor contributing to the perception of ORD's responsiveness to Agency needs. Regardless of the quality of research results, they are viewed as only marginally useful if available after statutory deadlines have passed. One can argue that in the long run "late" results will be integrated into environmental programs, *but this does not engender Program Office staff confidence in or support for ORD. The scientific and technical soundness of ORD results is crucial if EPA Program Offices are to susta~n their regulatory positions. Transfer of weak results by ORD will lead either to rejection of these results by administrators or to utilization with subsequent public embarrassment upon disclosure of a weakly supported position and/or reversal of the Agency position by the Courts. In addition to being scientifically defensible, research results must be targeted to meet Program Office needs. Needs must be commonly perceived and agreed upon by researchers and program administrators. Dictation of needs by regulatory staff to researchers can result in untimely and fruitless investigations; likewise, researchers with inadequate understanding of program needs may pursue scientifically sound studies which are irrelevant to the Programs. The understanding of ORD results by ~otential users is probably a major ingredient of the perception of responsiveness. ORD must not only deliver sound results in a timely manner, but must also translate these results into terms and concepts understandable to the users, i.e., the Program Offices. ORD has a responsibility to assist its users in understanding the strengths, weaknesses and full significance of those research results transmitted for Agency use. 20 PAGENO="0277" 271 The above ingredients of "responsiveness" relate to the research function as It serves regulatory needs. Each ingredient must be carefully developed and nurtured, literally on a project basis, if expectations of ORD efforts are to be fulfilled. With this brief introduction to the demands placed upon ORD, specific aspects of performance of health effects research and development in the Agency will now be discussed. E. What is an Investigatory Product in a Regulatory Agency? The investigatory product in a regulatory agency Is that body of scientific information and data base which is either available to or resides with the scientific staff. The product must be provided to the Program Office in a form that Is useful, understandable, and defensible in setting reasonable standards and for writing regulations. This scientific information can be provided to the Program Offices in many ways. The best way would undoubtedly be to have the research described and published in professionally peer reviewed journals, but information can also be provided throt~gh monographs, letters and verbal presentations. The key to the desired investigatory product is for the Agency to have an in- house core of capable scientists who understand the regulatory and standard setting requirements, who can perform the necessary literature searches, can perform their own research and evaluation, and can freely attend professional scientific meetings where discussions and information exchanges occur. 21 PAGENO="0278" 272 V. OBSEJ~VATIONS,OF CURRENT EPA RESEARCH AND DEVELOPMENT A. Identification of Research Needs ORD can be viewed as a large multifunction apparatus capable of responding in a variety of modes if appropriate planning of the necessary dynamics and a complete `tune-up" occur prior to "start-up." The initial step is to identify the required outputs. ORD outputs should be responsive to regulatory needs, in the short or long term. At present and, indeed, during the entire history of EPA, short term R&D needs have been stressed. We do not see any conflict between simultaneously sustaining research programs with long (years) and short term (months to years) goals, provided Program Office-ORD concurrence is reached as to these goals. Historically, Program Offices outlined needs according to their perceptions of the problem. It was a hierarchical planning process which gave the scientists at the laboratory little understanding of what was needed or why. Laboratory scientists often communicated with lower level Program Office staff who did not fully understand the needs and priorities of their program. There seems to be no systematic identification of information gaps (research needs) in the Agency. This identification should take place as soon as EPA receives legislation on which it must act; it requires close cooperation between the appropriate Program Office and ORD scientists, especially those in the laboratories. These staff members should carefully analyze the Act to assess what the Agency must do to gather the needed information and to fulfill the requirements of the Act. Additional research needs come from the process of drafting regulations and from writing the criteria documents when perceived needs for information are recognized. Better identification of needs takes place when there is a close association between ORD and the Program Office, but this must be directed throughout the Agency in a systematic way. Long-term (anticipatory) research in subject areas central to Agency responsibilities should be planned as a natural extension of the identification of gaps in the dit~a base. It cannot be designed in a vacuum, as an activ.ity to be initiated or terminated at will. When effective cooperation occurs between ORD laboratory and Program Office personnel and when effort is expended to define common objectives, goals, and plans, opportunities are likely to arise for defining relevant, long-term research programs. The perception of needs for longer term research arises from the interaction of key regulatory people and creative researchers who are in touch with the issues and the scientific literature. People who do research, read scientific literature, 22 PAGENO="0279" 273 attend meetings and work cooperatively with the Program Offices are those with the best resources to define needs. The Committee believes that the stress on identifying long-term research needs must come from ORD and that more attention must be devoted to identifying these needs and pursuing the associated research studies. The pilot research committees have helped to identify gaps deserving further research effort, to date only short term; but even this has helped to gain better insight into Agency priorities. Because of the large number of people involve~1, these pilot research committees are cumbersome, but they have forced a meeting of minds among key people in the Program Offices and ORD. In fact, the identification of research needs by individuals with diverse backgrounds and responsibilities Is *a very strong feature.of the pilot research committee effort and should be retained regardless of the ultimate fate of the activities of these committees. This should be expanded to include identification of long term needs. Several efforts at identifying research gaps and implementing research should be highlighted. The Drinking Water Program has been an example of effective cooperation in identifying and implementing research needs, whereas the Human Inhalation Exposure program at HERL, RTP (Chapel Hill) and the Animal Exposure Program at HERL, Cincinnati are examples of very poor coordination. In the area of pollutant inhalation studies on human subjects, the scientists of the Chapel Hill facility have attempted to implement longer range studies to predict and assess more accurately the potential adverse health effects of selected chemical agents. In general, ORD administrators have been sympathetic to funding short-term inhalation projects, but have not been supportive of longer term inhalation research programs. The Inhalation Toxicology (animal model) Program at HERL, RTP, on the other hand, was enthusiastic about its relationship with the Program Office. This group is well supported, largely as a result of a sustained effort by the section leader to keep close contact with ORD and Program Office personnel in Washington. Development of new methodologies was considered to be a major responsibility of the group working on animal inhalation toxicology; they expressed the desire to be involved in toxic substances support as well. This group also supervised contracts and grants. Management of both grants and contracts in addition to the "in-house' responsibility was seen as a desirable component of the total job done by the Inhalation Toxicology Section. A key element of this program seemed to be the desire on the parts of the Program Office and the laboratory to engage in cooperative planning and goal setting. The result is a very spirited and productive group of researchers. 23 PAGENO="0280" 274 Scientists in the Diesel Exhaust Program at Center Hill (Cincinnati) clear'y foresaw the emerging importance of diesel engines and attempted to start long..range research several years ago. These projects were turned down by ORD staff members in Washington, who have recently recognized the need for such studies. Work is now frantically underway to obtain needed results to meet the statutory deadline for establishment of diesel emissions criteria. B. Planning Research Projects 1. Budget Formulation During the period of our Committee review, the Agency was in the second year of zero based budgeting (ZBB), i.e., fiscal years 1979 and 1980 budgets were in progress. Funds are authorized and appropriated directly to ORD in categories related to enabling legislation or special projects. Prior to the introduction of the ZBB process, senior ORD personnel often established project allocations without communicating with Program Office managers. The zero based budgeting process has been an exasperating (but probably desirable) experience for all concerned..-Program Offices, ORD, and laboratories alike. It has forced a certain amount of communication and has led to some good, though tortured, outcomes, especially in the pilot research committees. However, communications are still occurring only between ORD and Program Office personnel of relative seniority. We perceive that many bench scientists in ORD do not understand the relationship of their work to overall ORD and Agency goals. If communication involved the laboratory investigators doing the work, even more effective decisions could be reached, while simultaneously gaining the commitment of the researchers to the work. An additional budgeting problem is the mismatching of personnel ceilings and funding for specific programs and laboratories. Numerous examples were found in which program areas in specific laboratories had very few or no people assigned and relatively large amounts of funds available. In a few instances, relatively large numbers of personnel were assigned with limited funds available. At the headquarters level, the view was frequently expressed that 0MB had minimized management's latitude for shifting personnel between programs to better match program needs and fund allocations. Laboratory personnel expressed a feeling of hopelessness in dealing with the problem and were, on occasion, forced into the unrealistic posture of showing, for the record, programs with substantial funding managed with zero personnel; obviously this does not happen. The people who are assigned to manage the program simply charge their time to some other program that has a more adequate manpower ceiling. The result is manpower accounting by progam that is suspect, at best, and probably of limited value. 24 PAGENO="0281" 275 Clearly, if laboratory directors are to be effective research managers, they must begiven the latitude to utilize assigned personnel without rigid program area constraints. A change in approach should allow laboratory directors to place Increased emphasis on developing the appropriate mix of disciplinary skills of their staffs to better serve, current and future program needs. Allocation of travel funds is another budget problem. When travel funds are allocated to the laboratories, consideration should be given not only to the number of scientists in the laboratories, the degree of participation in extra laboratory Washington mandated activities, and the required extramural program monitoring required, but also to the geographic location of the laboratories with respect to these activities and to the location of national scientific meetings. Furthermore, increased flexibility should be given to the laboratory directors for control and utilization of travel funds. For example, the laboratory director at the ERL in Duluth should be authorized to approve travel for his staff to go to Canada. One of the major functions of this laboratory is scientific cooperation with their counterparts in Canada. Yet this collaboration is minimal because travel to the Canadian laboratory in Thunder Bay is considered foreign travel and must be approved each time, well in advance, by ORD headquarters in Washi ngton. 2. Research Program Formulation The Committee senses that the major contribution of the pilot research committees in program formulation has been to overcome previous inadequacies in planning and to initiate discussions of research by the many individuals with an interest in the outcome and utilization of the work. The previous "old system" of hierarchical planning failed to establish understanding and commitment by those who should have been involved. The pilot research committee approach to planning has been warmly endorsed by laboratory staffs because they, personally, provided inputs and gained familiarity with and perspective of the entire program and an awareness of.their projected contributions to the entire program. This type of "grass-roots" motivation must be retained, but the leadership must also be involved in the process. Methods need to be established to institutionalize the involvement and commitment of the staff through proper involvement of laboratory directors, as well. Pilot research committees are a useful means to an end, but they are no substitute for accountable leadership, which must be responsible for the integrity and quality of the final product. When laboratory personnel did feel that they had an influence in setting priorities, they became involved with input to the Program Offices, became involved in the objective 25 PAGENO="0282" 276 setting, and became involved in the design of protocols to meet objectives. The drinking water projects are outstanding examples and illustrate many of the elements of success that need to be emulated by others. The reputation of the people, their professional standing, and the history of performance stemming from the Cincinnati laboratory and its predecessor, the Taft Center, are influential factors which command the respect and attention of the Program Office. A critical factor In responsive and quality programs is the need to maintain a continuum of qualified, knowledgeable personnel. Also, it Is Important to recognize that, in the drinking water program office, there are counterparts to ORD staff who understand the scientific and technical issues. 3. Pre-project Evaluation of Productivity and Costs The laboratories in ORD are mostly media oriented, and scientific program projects and resources are assigned accordingly without assessment of the cost-effectiveness of performing research in each specific laboratory. ORD, or an outside agency, should perform a yearly assessment of each laboratory's past performance with respect to the quality of the research information produced, the timeliness of deHvery of research results, the cost- effectiveness of the laboratory, and other factors which deal with a laboratory's performance and productivity. Only after such assessment has been performed and deficiences corrected should the scientific work (decision units) and resources be assigned to a specific laboratory. 4. Good and Poor Planning a. Some examples of good responses b/,Y/ORD -The drinking water program at Cincinnati -The animal inhalation toxicology program at RTP -The pesticide pilot research program involving program and laboratory personnel -The Wenatchee Laboratory studies of field exposure of applicator to pesticides (relevant work goes back in history and should be better utilized) These good responses all have a very important common element; namely, the participants work at good communication. Objectives, goals and plans are understood by the affected parties. Solid scientific approaches are being utilized and researchers in the laboratory are involved with personnel in the Program Offices. 26 PAGENO="0283" 277 Figure Diagrammatic Representation of Old and New Systems to Develop Experimental Protocols at Bench Level of Investigation Old System fpri orit- Lizationi 1fun~T~i1 J~cisi onJ~ I To Laboratories for -I Development of Accom- plishment Plans New System Assessment of Research Needs by ORD Headqtrs (from internal ORD and external sources) Lists of In- dividual Pro- gram Research Priorities Development of Objective Statement by Hdqtrs ORD (includes, statements of scientific objective plus dollars ai~d man~5ower) - Laboratory Development of Work Unit Document for Each Accomplishment Plan (retained at Lab- oratory) ____________ Lab Develop Protocols Individual in-house Projects, Contracts, or Grants 27 PAGENO="0284" 278 b. Some examples of poor responses by ORD The Human Inhalation Facility at Chapel Hill is an unusual facility, engineered to deliver the desired exposure levels, but the scientific program or plan to utilize it is totally inadequate-- a very conspicuous waste. The Diesel Exhaust Program at Center Hill was prevented from doing adequate dosage response tests because of directives from Washington. The Epidemiology Program associated with the Diesel Emissions Program lacked adequate and mature direction. C. Performance of Research EPA's intramural health effects research is conducted in two major laboratories and in portions of three other laboratories, which were established primarily for other purposes. The major laboratories are Research Triangle Park, North Carolina, and Cincinnati, Ohio. Small programs are in effect at the environmental biology laboratories at Duluth, Gulf Breeze, Narragansett, and the Environmental Monitoring and Support Laboratory, Las Vegas. There are also health-related field laboratories in Wenatchee, Washington and W. Kingston, Rhode Island. All of the laboratories have close relationships with neighboring universities; in some cases the laboratories are located on university campuses (the main Cincinnati Laboratory, the W. Kingston Laboratory, and the Human Inhalation Facility at the University of North Carolina, Chapel Hill). 1. Adequacy of Facilities for Research The facilities of the health effects laboratories are generally excellent. The major exceptions are the RTP laboratory and the W. Kingston facility, neither of which was built for biomedical research purposes. Some laboratory buildings, on the other hand, were constructed for biomedical research within the past five years (e.g., Cincinnati). In spite of limitations of physical plant, such as the absence of modern animal care facilities at Research Triangle Park, EPA laboratory staff have improvised and created the pbysical conditions necessary for good research. The laboratories are, in general, notably well-equipped for physical and chemical analysis and modern biologic research; they also appear to have adequate library, data processing and statistical services on the premises or conveniently accessible. The Committee did not conduct a formal audit of good laboratory practice at any laboratory visited. However, the Committee did consider as part of their general review many of the items that would be considered in such an audit. It was the 28 PAGENO="0285" 279 Committee's perception that additional attention is needed in this area if EPA laboratories are to achieve the same standards that EPA expects from research conducted outside the Agency and submitted to the Agency. Some of the specialized physical facilities are unique in the cabability of their chambers to provide accurate concentrations of gasses and aerosols at very low concentrations for human exposure. The inhalation facilities at Cincinnati for experimental animal exposures and the Inhalation Exposure Facility at Chapel Hill for controlled human exposures are good examples. Housekeeping and safety programs were generally quite satisfactory. Animal facilities in only two laboratories were examined (Cincinnati and RTP). The facilities at Cincinnati have been approved by a national animal facility accreditation committee, while no such accreditation has been attempted at RTP due to its many deficiencies. Our Committee agrees with the findings of the accreditation committee and suggests that EPA devote the necessary resources to bring the RTP animal facility into similar compliance. 2. Staffing for Research The Committee recognizes the role of history in present EPA staffing, not only the legacies of personnel from the predecessor agencies and programs that were coalesced into EPA in 1970 but also the effects of legislative actions, 0MB decisions, and civil service regulations. The Committee, therefore, addressed only limited aspects of the total problem, including the effects of imbalance between funds available for extramural research and professional staff available to monitor the research, the availability of research staff to make effective use of special facilities, and the utilization of scientists from academic institutions to supplement EPA research staff. Over the past three years, there have been several increases in research appropriations, without proportional increases in personnel (Energy-Environment Act, TOS.CA, CAA amendments, etc.). One result is an increase in the burden of monitoring extramural grants and contracts. We found great variability from one research program to another in the distribution and intensity of the monitoring load. There was also much variability in attitudes toward an extramural program. Ideally an extramural project should complement and enrich the intramural.scientific endeavor. The individual research worker may or may not wish to expand his (her) own research effort through an extramural grant or two. 29 PAGENO="0286" 280 The Committee found that some EPA scientists were attempting to monitor six or more extramural projects and had no time for their own research. In one instance, every member of a laboratory division was fully occupied monitoring grants or contracts; there was no intramural research. This is an unsatisfactory method for establishing and maintaining a program of high quality; it is made even worse when appropriations are increased without additional staff increases, as frequently happens.' EPA's special inhalation facilities were costly to build and are expensive to maintain (over $1 million annually for one facility). It is important that such facilities be competently and fully staffed to be effectivly used. In fact, these facilities are seriously underutilized, due both to lack of skilled personnel and to lack of funds for research projects. At the same time multi-billion dollar decisions are being made which would benefit greatly from the kind of information these laboratories could provide (for example, the standard setting for ozone and NO2). One practice which increases available manpower and promotes intellectual quality is the exchange of staff between universities, industry, and the Agency (Interagency Personnel Agreement-IPA). The exchange is largely from academic institution to research laboratory, and we found universal enthusiasm for this arrangement within the laboratories. However, there seems to be little systematic effort to recruit IPA5; most of the arrangements develop out of personal acquaintances. While these arrangements are mutually benefical and should be encouraged, EPA has recently adopted a policy which will make university recruitment much more difficult--an academic institution must guarantee a position for a returning IPA. This would severely limit opportunities for young scientists in the early post doctorate period of their careers. 3. Accountability for Expenditures The Committee did not discover any managerial accounting and auditing efforts within ORD to (a) analyze the success or failure of research projects after their conclusion or (b) apply accounting methods to individual projects to determine dollar allocations to equipment, salaries, travel, and services. `There is a remarkable and conspicuous lack of managerial auditing procedures in the ORD operation. After initial formulation of the decision units and their overall budgets, the laboratories are assigned the implementation of projects. In general, it is at the laboratory level that work unit productivity and costs must be tracked on a continuing basis and evaluated for effectiveness and adherence to or departure from categorical costs of ORD operations. The insensitivity to project evaluation after completion of effort was reflected by attitudes of managers and bench scientists. The unawareness of costs was also widespread. 30 PAGENO="0287" 281 D. The Quality of Health Effects Research The quality of research in EPA is important not only because any worthwhile research should meet standards acceptable to the scientific community but also for reasons derived from the regulatory nature of the Agency. Presumably all research supported by EPA should be related in the short or long term to the development of a regulation or standard. In this context scientific information is likely to be examined critically in an adversary relationship. Any sloppiness in conduct or interpretation of the work is likely to weaken or destroy EPA's position. Another characteristic of a regulatory agency is the importance of the credibility of research supported by the Agency. Just as research supported by industry Is often suspected of bias, whether justified or not, so research supported by EPA is often alleged to be biased toward the overzealous protection of public health. This question of credibility is a difficult one and is never easily solved. For EPA it implies a great need not only for the highest standards of quality in scientific work but also for active and constant efforts o-f EPA scientists to participate in and have the support of the scientific community. It was our experience in visiting the health effects research laboratories and Program Offices that EPA has many scientists who would be welcome in the nation's universities and private research institutions. Many of the scientists we talked to were clearly dedicated to the best traditions of public service in carrying out the missions of EPA. The Committee found areas of high morale and sense of accomplishment, but was disturbed to find areas of low morale and frustration from frequent changes of research direction or even the absence of a sense of direction, often stemming from frequent changes in leadership. In trying to assess quality, the Committee used what it could of the usual criteria for evaluation. The legal counsel's interpretation of the Privacy Act did not permit the Committee to request a curriculum vitae of any scientist, but many offered them voluntarily. Th~T~Tlowing Information was usually obtained from each research unit: the number of staff with research doctorates; the scientific publication record of the unit, in peer reviewed journals and others; the statistical and computational resources of the unit; the procedures used for peer review; and a sense of the intellectual climate of the unit. The Committee also~ examined the procedures used in conduct of "extramural" research through grants and contracts. Consultants were added as necessary to evaluate specific programs and special facilities such as animal housing and care.. These and other aspects of quality assurance are described under the headings that follow. 31 PAGENO="0288" 282 1. Publication and Reporting of Research Results Scientific investigators are part of a tradition which places great importance on scientific peer review of results prepared for publication in professional journals. As with other characteristics, there was high variability of attitudes and procedures among the different laboratories and divisions of laboratories. Some resembled university laboratories in their emphasis on scientific peer review of research plans and peer review of manuscripts before submission to high quality journals. In these cases publication was seen as an incentive for promotion and professional advancement. Publicationin peer reviewed journals enhances the probability that a product of research will "stand up in court." These research units usually had strong interactions with local universities and promoted attendance at scientific meetings, development of symposia and workshops, and participation by IPAs. At the other extreme were units that appeared to put no emphasis on publication in the scientific literature and who sensed that there was no incentive in EPA for such publication. Others recognized the desirability of such publication but felt so overwhelmed by other responsibilities that they could not find time to publish. Some felt that internal reports were all that the Agency expected. The policy on review of manuscripts varied from in-house review only to submission of the document to up to five external reviewers. Some' scientists not only met the formal requirements but also sent their manuscripts to one or two personal acquaintances whose opinions they particularly valued. To ensure acceptability of research results, the studies must be reviewed by one's scientific peers and published in a reputable journal. Failure to so treat results of research investigations involves the risk that review will occur at a later date, with possible refutation of results and embarrassment to the Agency. Specific mechanisms must be established to require peer review of ORD results and to encourage prompt publication in peer reviewed journals. Attendance at professional scientific meetings to present research results is not consistently encouraged. It has been argued by some laboratory staff that peer review and publication are not necessary for mission-oriented research, the EPA focus. The Committee rejects this viewpoint; applied research, often with short-term goals, must be reviewed and published as surely as that, related to more fundamental Investigations. Applied research is the final product of years of basic research and should receive even greater, review. 32 PAGENO="0289" 283 2. Quality Assurance in Grants and Contracts Examinations of this important component of the health effects research program revealed serious problems, which affect in-house performance as well as the quality and relevance of extramural research. One aspect is wide variability in funding from year to year and the assignment of funds without any addition of personnel (this happens with the Energy-Environment "pass-through appropriation, for example). Another serious problem is the uneven distribution of monitoring responsibility among scientists in a laboratory unit; some are overloaded to the extent they cannot possibly do a satisfactory job. Both the old and new planning systems give authority to laboratory directors to obtain extramural services through award of contract or grant funds. Laboratory directors rely upon their managers to allocate resources under their juris- diction to complete work unit tasks. Thus there is local or. section management of contractors performing services for ORD. in depth examination of several of the laboratory, sub-unit extramural program procedures for contractor selection, monitoring and evaluation revealed good examples of contractor orgrantee selection based on submissions and competitive selection. There were also examples of selection of weak or incompetent applicants, failure of laboratory staff to monitor performance, and almost a total absence of evaluation of the final submission and its relevance to the ORD program and EPA in general. Some scientists see grants and contracts as a desirable extention of the scope of their personal efforts and en- hancement of their contacts with the scientific community. Indeed, a healthy balance between intramural and extramural work can benefit both EPA and the universities. Th~se kinds of relationships do not currently appear to be the norm. Three kinds of arrangements are used for support of the extramural research program: contracts, grants, and cooperative agreements. Increasingly, contracts have also been used to provide operations and maintenance services directly supporting in-house efforts. The Committee did not systematically examine the quality of contract research and did not look at all of the cooperative agreements, a recent development which has been little used so far. EPA has more specific requirements for the award of contracts than for grants. The Committee was told repeatedly that grants are being used increasingly, because processing them Is easier and takes less time (three or four months, instead of six months to a year for a contract). Examination of selected files indicated that the review procedures for grants were being abused in a~ least one 33 43-778 0 - 79 - 19 PAGENO="0290" 284 laboratory. There were examples of critical reviewers recom- mending that the work not be funded or stating that the proposed project was only marginally acceptable. Yet the project officer proceeded to rationalize the reviewer's comments and indicated alterations in the study protocol of the grant applicants which would overcome the objections of the reviewers. Because the proposed project review and the project officer's revisions were performed near the end of the Federal fiscal year, the funds were awarded without either further submissions or a modified submission by the applicant. In one example, inquiry revealed that one year later the project monitor still did not know if the grantee had modified the protocol, added additional personnel, etc., as was recommended by reviewers and as was rationalized by the project officer in justification of awarding the grant. In other examples the Committee found that external reviews were not obtained before award of grants. (Some EPA staff informed the Committee that soliciting external reviews of contract proposals was illegal, except with permission of the applicants.) Scientists were encountered who had difficulty keeping track of the number of awards they were assigned to monitor; they were not familiar with the details of extramural contract or grant work as it progressed. The quality of investigatory work external to EPA laboratories and supported by ORD funds was highly variable and of great concern, mainly because ORD oversight was usually lacking. It requires project monitoring effort to ensure that contractors or grantees perform re,sponsive work on a timely basis. There is an efficient "mix" of one's own research and that of others that can be effectively monitored. Conversations with ORD laboratory staff suggested that monitoring one or two contracts or grants totalling perhaps $lOO-150,000 per year would be a stimulus to a senior ORD scientist. More extensive monitoring responsibility is a burden to the ORD scientist a.nd, even more important, he/she cannot efficiently discharge the monitoring responsibilities. Some research units are so heavily committed to monitoring grants and contracts that no scientist in the unit has any time for his/her own research. TEe lesson is a clear one; Congress should not increase R&D funding without concomitantly increasing ORD staffing or without identifying alternative approaches. A frequent complaint was that monitoring was handicapped by the absence of travel funds for the project officer to visit the institution where the research was being done. Grant applications are of two types--solicited and unsolicited. The latter presumably represents the spontaneous interest of university scientists todo research on environmental problems in which EPA might be interested. The 34 PAGENO="0291" 285 common response to the Committee's inquiry was that unsolicited grant proposals have almost no chance of being funded, primarily because they are judged "not relevant." It seems clear that EPA scientists are using grants in lieu of contracts, that they monitor them like contracts, and that there is little opportunity for "investigator Initiative." The mechanisms for soliciting grant proposals vary from one unit to another. We found little evidence that EPA has found effective ways to Interest university scientists in its problems on a sustained basis. Another practice, employed to extend the time for longer.. term research but with the potential for abuse, is the "front- end loading" of a newly awarded grant, In this practice the amount of the award may be as much as twice the amount of the first year's budget. The investigator can then request an extension for a second year without additional funds, an action routinely granted without a critical review of research progress. The Committee does recognize the need for assured funding of projects that may require more than one year to complete. However, if funds required for more than the first year's operation must be obligated, the project must be carefully monitored to assure that funds for the second year are required and appropriately used. Another shortcoming of the present EPA system is the absence of a routine operational audit of the quality of extramural research. Individual scientists and laboratory directors told us that a contractor or grantee who performed poorly was not likely to obtain another grant or contract. This informal and spottily used system is not adequate to assure the high quality of extramural performance. ORD's entire program to make extramural awards of funds under contracts, grants or cooperative agreements requires a thorough overhauling. Extensive standard operating procedures for awarding grants and contracts exist in the Agency; they are voluminous, difficult to comprehend, and are avoided by laboratory staff. It is necessary to.establlsh simple, explicit procedures to be followed by laboratory directors and scientists throughout the life of an extramural award. At present, laboratory directors are expected to satisfactorily complete work unit tasks; extramural projects are their choice and responsibility. The Committee recognizes the need for extramural assistance, particularly if the trend continues to increase ORD dollars without increasing the number of positions for investigators, but the procedures for extramural programs must be placed on a more defensible basis throughout ORD. 35 PAGENO="0292" 286 3. Career Opportunities The civil service system was examined as an influence on the quality of research programs and on career opportunities for EPA scientists. There were several examples of negative effects of the civil service system; for example, it does not permit the flexibility to hire new people or to move people as program orientation shifts. Consequently, there are cases in which excellent scientists are placed on projects where their expertise is not needed and where they have to be "re-tooled'. Although the Committee talked to people who had been promoted because of the quality of their research, more frequently promotion related to the assumption or increase of administrative responsibility. Many times a good scientist makes a poor administrator, but the scientist takes the administrative position for the higher salary, not because he or she has management skills. Talented researchers must be encouraged to continue as investigators. Mechanisms must be instituted to further their professional development and their allegiance to the Agency. It appears that the policies and procedures for advancement do not encourage the emergence of either top scientific or managerial performance. The system does encourage job-hopping by bright people, particularly those in Program Offices. A promotion ladder based on scientific achievement rather than administrative responsibility would help to solve this problem. Many industrial research laboratories use dual ladders for advancement-- administrative and research. Senior research personnel are rewarded with remuneration and privileges comparable to those of a senior manager. ORD is experiencing difficulty in retaining research physicians, epidemiologists, and toxicologists, among others. At the time of this writing, the Human Inhalation Laboratory in Chapel Hill, N.C., a unique facility, is virtually without physicians to perform the research vital to scheduled regulations in the air media. Administrative mechanisms should be developed to offer a challenging career ladder to these professionals if first rate health effects research is to be performed in ORD. The Committee recognizes that many of the reforms addressed elsewhere in this report will improve conditions for these professionals, but an explicit analysis of conditions and incentives related to a research career in ORD must be performed and improvements implemented where necessary. 4. Other Components of Quality Assurance Per.formance evaluations of individuals and laboratories are often perfunctory. Many individual scientists were unclear about the criteria applied to their evaluations and advancement. 36 PAGENO="0293" 287 Evaluation of laboratories is not being done in terms of good laboratory practices, rewards and incentives, budget and resource allocations, and accountability. Personal scientific integrity is difficult or Impossible to determine in a study of this kind. To the extent that personal conversations, attitudes expressed, and measures taken to assure the quality of research, design, and analysis can be used to assess scientific integrity, the Committee was favorably impressed. If there were subtle biases in the interpretation of research results, they were not detected in this study. There are periodic "program reviews" in which head- quarters' staff members visit the laboratories. These are described by the laboratory scientists as superficial "show and tell" sessions. There is limited scientific feedback from headquarters' staff, and the only benefit to the laboratory is the stimulus to prepare material for presentation. By contrast, it was noted that when NIH is involved in a jointly sponsored project, there is a visit by NIH staff members, who conduct an intensive critical analysis of the proposed r-esearch project. EPA staff who have thus been "nailed to the wall" to defend their projects say they would welcome this kind of evaluation of EPA projects. There appears to be a general lack of understanding of the Science Advisory Board and its constituent committees by laboratory staff. In view of this, it was not surprising that the Science Advisory Board was criticized for its lack of scientific interaction, failures irv communication, and lack of subsequent feedback. 5. Interagency Agreements The Interagency Regulatory Liaison Group (IRLG) is a new activity which seems to be off to a promising start. Since it is a developing program, no attempt was made to evaluate it. Other programs involving interagency agreements have had mixed success, at best. EPA has substantially supported the National Center for Toxicologic Research since its inception, with little evidence of any product benefiting EPA. Disap- pointment was also expr.essed about interagency agreements with Los Alamos and Oak Ridge National Laboratories and three of the National Institutes of Health. A significant portion of EPA's health effects research is supported by interagency agreement for the special Energy- Environment appropriation. No attempt was made to examine this program in detail. 37 PAGENO="0294" 288 E. Other Relevant Topics 1. Long Range, or Core, Program Research There are subjects for research which are important to several of the media programs. Examples are the properties of particle dispersions, be they in air or water, because of their relevance to collection of the disperse phase prior to effluent discharge, to particle deposition in the human respiratory tract and to particle retention or solubilizatlon in the human gastrointestinal tract; epidemiological methodology because it is a major tool for relating exposures to pollutants to potential effects in the exposed population; and techniques of risk assessment and presentation of the implications prior to judging acceptability of risk. There should be a long term ORD investment in researchers and facilities to develop highly active and productive groups in those areas of research which are central to large segments of Agency regulatory activity. This investment is currently being augmented by initiation of extramural university centers. It is planned to shuttle ORD staff between their resident laboratories and the centers for "leaves of absence" during which they can pursue studies in core areas while upgrading their capabilities on a university campus. We applaud this plan, but also see the need for small, active core research groups in ORD laboratories. Allocation of a specific percentage, at least 10%, of the ORD budget for relevant research in core subject areas, but not on projects specifically traceable to immediate program needs (6 months-2 years), is a reasonable assignment of funds. There is no obstacle to this programming of *funds under the present procedures for funds authorization. They are part of the funds assigned to research for the specific statutes, because results will be applicable to those statutes, as well as to others. 2. ORD/Congressional Staff Information Transfer The relationship and relevance of ORD projects to regulatory needs is not always obvious, particularly to non.. scientists. It is essential that members of Congress and their staffs understand the efforts of ORD. Such understanding does not develop accidentally. ORD should develop .a plan to regularly inform interested members of Congress and their staffs of the results of ORD efforts and the manner in which they further the goals o~ statutes administered by the Agency. ORD's investment in what is essentially an educational program for legislafors should involve ORD's most senior scientific staff. It is critical that this communication effort include laboratory personnel who are directly involved in the conduct of research. We note the 1978 and 1979 Research Outlook efforts by ORD, but believe efforts must go far beyond this and must incorporate personal communications, as well as transfer of printed information. The concepts of chronic disease, multiple etiologies of disease, host factors, and cumulative effects, to name only a few, are complex and crucial to understanding the underlying approaches to research in ORD. 38 PAGENO="0295" 28~ VI. UTILIZATION OF ORD RESULTS Different Program Offices utilize ORD research results to different extents. Senior program managers indicated that they did not look to ORD for results; rather, they sought capable laboratories and investigators related to their needs, be they within or outside the Agency. A Radiation Program manager indicated that ORD has little capability to assist them; ORD has no capabilities in the area of biological effects of noise. ORD appears to have little involvement with the Toxic Substances Office. The Water Program draws heavily on ORD at the present time, and recently ORD had a major involvement in the formulation of criteria documents for 65 water pollutants. The input of research to the screening test and risk assessment process was clearly evident from the Drinking Water Research Program in Cincinnati and the Pesticide Programs at the Gulf Breeze and Wenatchee Laboratories. Their scientific standing is recognized. The respective leadership has maintained the kinds of communication necessary (with the help of pilot research committees) to keep the personnel in Washington knowledgeable and involved. It is not surprising to find that the utilization of results from ORD projects is not carefully tracked when the joint planning of research by Program Offices and ORD Is in its infancy with the pilot research committee program. Program managers elaborated on many needs not being met by ORD; there were few illustrations of ORD responsiveness to programs and subsequent incorporation of results into regulatory programs. On the other hand, ORD staff were often praised for their responses to requests for preliminary review of regulatory documents, consultation on imminent regulatory submissions to the courts and, in general, what can be characterized as technical support to the Program Offices. The Committee was not able to estimate the average percentage of ORD professional staff time devoted to technical support; It varied with individual research sections. It was clear that in some instances it represented a significant portion of some Individuals' time. This technical support has on some occasions played a critical role in the Agency's formulation and defense of regulations. The ORD function in the Agency is defensible mainly on the basis of program utilization, of inslgt~ts and results developed intramurally or extramurally under its auspices and guidance. The Committee found that ORD did not fully recognize or accept this `criterion for judging its efficacy, had not developed mechanisms for efficient utilization of research results by Program Offices, and did not maintain records of results which had been incorporated into regulations. 39 PAGENO="0296" 290 VII. STATUS OF IMPLEMENTATION OF TWO SETS OF NATIONAL ACADEMY OF SCIENCES (NAS) RECOMMENDATIONS TO EPA The analytical study of Research and Development in the Environmental Protection Agency conducted by *the Environmental Research Assessment Committee (John M. Neuhold, Chairman), of the National Academy of Sciences, National Research Council,in 1974 and 1975 set forth a number of useful recommendations.* Before that, a Review Committee on the Management of EPA's Research and Development Activities (Robert W. Berliner, Chairman) had developed recommendations submitted to the Agency on August 27, 1974. Our Committee (HERRG), therefore, in its collective judgment, has attempted to evaluate the extent to which former recommendations have or have not been implemented. This final exercise was undertaken at the. end of our study when all visits had been completed. It was possible by this means to add a different, but closely related, viewpoint against which to compare our own observations of performance and changes during the past four years. Although there has been significant improvement in selected aspects of EPA research planning and management, most notably the development of pilot research committees with representatives from across the Agency, the overall planning and management system is still unsatisfactory. Many of the reasons for inadequacies in the system in 1974 still exist today and will be enumerated in the following. A. Recommendations from the Environmental Research Assessment Committee of 1975 ** (1) "EPA's research and development should concentrate primarily on support of the Agency's decision making and anticipation of future problems." There are improvements arising from better communications between research workers in the laboratories and the Program Offices. The pilot research committees have helped establish communications and understanding. *Analytical Studies for th~ U.S. Environmental Protection Agency, Volume III, "Research and Development in the Environmental Protection Agency," Environmental Research Assessment Committee, Commission on Natural Resources, The National Research Council, National Academy of Sciences, Washington, D.C. 1977. **n~id. page 2. 40 PAGENO="0297" 291 (2) "EPA should supplement its primary research responsibilities with some fundamental research to help advance understanding in environmental sciences and technology." Planning for fundamental or longer term research is still inadequate. However, to achieve the right kind of balance there first needs to be a close and direct relationship between researchers and program managers. Both must understand the research process and information needs of the regulatory process. (3) "A new legislative mandate will be required if EPA is to conduct effective anticipatory and fundamental research." The HERRG Committee does not agree that additional legislation is needed to fund and conduct "anticipatory and fundamental research." (4) "We recommend that the Office of Science and Technology Policy (OSTP) develop a federal environmental research, development, and demonstration strategy that includes designation of the appropriate roles of all participating federal agencies and existing interagency coordinating committees, and delineation of the relationships between federal and nonfederal research and development. The OSTP should coordinate the implementation of the strategy through its mandated consultations with the Office of Management and Budget (0MB) about the scientific programs of federal agencies." This recommendation has not been followed, per se. However, the Interagency Regulatory Liaison Group is seen as an excellent initiative which has the potential of reducing duplication and confusion among agencies. Better coordination of research efforts and better agreement on the methodologies applicable to hazard assessment are encouraged by this Committee. (5) "We recommend that the management of all research and development in EPA be centralized in the Office of Research and Development (OR&D).' There seems to be progress in centralizing the management of R&D within ORD, but a number of Program Offices administer R&D contracts and grants directly. The Committee urges that this Academy recommendation be implemented to assure that proper oversight and scientific peer review be applied whe~never research is conducted by the Agency. 41 PAGENO="0298" 292 (6) "EPA's research program needs to be better organized for balance and continuity, through planning developed around a logical conceptual framework of environmental protection..." A number of areas within the present EPA research and development program are still not aligned within a logical conceptual framework of environmental protection and thus are not as effective as they could be. The conceptual framework proposed in the earlier NAS/NRC report (1977) still appears to offer a sound framework for the assessment of research needs, the planning and conduct of research, and the utilization of research results. The framework is shown below: Framework for Environmental Protection 42 PAGENO="0299" 293 (7) "A central function of scientific support to decision making should be to provide integrated assessments of available scientific, technical, and economic data pertinent to pending decisions in forms suitable for use by Agency decision makers. We recommend that the importance of this function be recognized by giving it formal status and organization in OR&D." The importance of integrated assessments continues to be recognized, and the Agency is moving toward establishing the formal organization required to make such assessments. When such an organization is fully operational, it should be of major assistance in providing information that is useful to the regulatory decision makers; but of equal importance is inform- *ation that is crucial for the planning of a responsive research program. Carefully conducted assessments can identify gaps in research information or parameters that have the greatest influence on the effects of emissions. In the absence of such assessments there is a risk that research efforts may be directed to developing information that may have limited value in establishing or reassessing standards or in guiding their enforcement. (8) "The research planning system now in use in OR&D, characterized as `top-down" in structure, should be retained for research in support of decision making. For anticipatory and fundamental research, however, we recommend a "bottom-up" scheme that relies on the scientific community to identify research needs." Except for the pilot research committees, the planning process remains "top-down." Substantial improvements are needed to achieve involvement of those generating and using the data. (9) "We recommend that block funding of extramural grants, contracts, and interagency agreements be considered as a mechanism to establish centers of excellence, federally funded contract research and development laboratories, and umbrella interagency agreements to supplement the intra- mural research and development program." To date, block funding mechanisms have not been extensively used by ORD, although legislation has provided the opportunity for use of cooperative agreements that may very well match ORD needs. ORD has made preliminary plans for using such agreements and should proceed expeditiously to implement their use. Such agreements offer a~ji opportunity for a complementary approach to the present system of grants and contracts for extramural performance. 43 PAGENO="0300" 294 (10) "All proposals and completed research should be subjected to review on their technical merits by scientific and technical peers." Peer review of proposals and completed research was inconsistent and, in many cases, inadequate. (11) "We recommend the use of a parallel grade advancement system, based on performance of research, that does not require researchers to assume administrative or managerial tasks to attain promotions." There was little evidence of implementation of a parallel grade system. In some cases, individuals have accepted administrative or managerial assignments based on the perception that such assignments are critical to obtaining promotions. B. Recommendations of the Review Committee on Management of EPA~s Resea~h and Development Activities * The Review Committee report noted that the present (1974) "Office of Research and Development planning and management system fails to meet the needs of the Agency" and proceeded to identify two main categories of failure: (1) the nature of the system itself and (2) external constraints as perceived by the ~0ffice of Research and Development and communicated to the Review Committee, 1. The nature of the system itself. a. "Planning is separated from responsibility for execution, leading to severe resentment among performing researchers. The assignment of responsibility for specific actions and decisions is difficult." There is still an inadequate linkage between planning and responsibility for execution that is apparent, in varying degrees, at all levels of the organization below the Assistant Administrator for Research and Development. An individual researcher charged with responsibility for performing a task may have no input to the planning of that task. b. "Priorities do not reflect the needs of regulatory offices and regional offices because of the `vacuum cleaner' approach to soliciting ideas, and the system-induced barriers to using comm~n sense in the selection process." *If~jcj. page 96. 44 PAGENO="0301" 295 There has been improvement inthe establishment of priorities in selected areas, most notably those for which pilot research committees have been established, to yield a research program potentially more responsive to the needs of the Program Offices. In other areas, the research program is less clearly defined and priorities have not been established. Faced with necessarily limited resources, the responsible individuals have frequently elected to continue work in all areas at a reduced level of effort rather than electing to eliminate or defer the lowest priority projects. The result is a reduced potential for success in the highest priority areas because of lack of funds. c. "Inadequate attention has been paid to the possibility for trade-offs, or modifications in budgeted costs, among various projects. This has aided in the development of a situation where there is only a series of discrete projects and no Agency program. This situation is further aggravated by the absence of long-term (3-5 year) p1 anni ng." Long-range planning within the Agency remains inadequate. The large portion of the planning within ORD is necessarily dependent upon the needs identified by the Program Offices. These long-term needs have often been inadequately stated, if at all, thereby handicapping the development of a responsive long-term research plan. It was originally anticipated that the pilot research committees would develop a strategic plan for their areas of responsibility. However, this was not done, in part because of the timing and pressure of the ZBB process which forced the pilot research committees to take a shorter- term outlook. An additional factor which should also be recognized is the reluctance of some individuals tO engage in defining a strategic plan until they are certain that managers are serious about the effort. d. " The complexity of the system makes It counter-productive. The large amount of paperwork and excessive bureaucratic review is a wasteful consumption of time and energy. The needs of the Agency are complex; however, this does not change--but rather heightens--the need for a simple and understandable planning and reporting system clearly directed by the Assistant Administrator and in which field personnel have a real participatory input." 45 PAGENO="0302" 296 The planning and management system is still extremely complex, involves a large amount of paperwork, and is often a waste of valuable time and energy. An inadequate amount of authority has been delegated downward to the laboratory directors and lower echelons of the Agency. In those cases where authority has been delegated, there appear to be excessive requirements for keeping all upper levels of the Agency informed. One example is the use of the highly structured quarterly "Project Status Reports," which include detail at the task level (tasks ranging in expenditures of less than $10,000 to over $200,000 per year); the volume of material developed at the laboratory scientist's level is passed successively to the Division Director, the Accomplishment Plan Manager, and the Office of Health and Ecological Effects and its various staff units. e. "Accountability is made impossible by the parallel but separate management systems--some for housekeeping and the others for program content--and by the hopelessly complex Program Area Manager-Program Element Di rector- Program Assessment Group-Strategies system which obfuscates management responsibility." The chain of accountability is extremely difficult to trace from the laboratory scientist (either in-house or engaged as a contractor or grantee) to the Assistant Administrator for Research and Development. The "chain of command" is excessive with numerous intermediate steps that serve only to delay or, in some cases, reprocess information without serving any clear management functions to enhance research productivity, efficiency, or responsiveness. Indeed, in many areas the number of information reprocessors and/or relayers makes it difficult to identify the laboratory scientist. f. "Excessive requirements for detail at all planning levels lead to an oversized headquarters staff and to the stifling of innovation in the laboratory." The level of detail required at all levels and the transfer of materials with limited informational or management value continues to contribute to the maintenance of an overly large Washington staff. In what appears to be a contradiction, the Washington staff is understaffed in relation to the amount of material being transferred and processed. Unfortunately, much of this effort is misdirected. Because of the attempts to maintain detailed accountability of even extremely small projects, the innovative responsibilities of the laboratory scientists ~continue to be unfulfilled. 46 PAGENO="0303" 297 g. "The existing management structure does not allow for the corrective feedback and flexibility which are essential to any successful research and development program." Because the "chain of command" is so long and the communication pathways are jammed with trivia, corrective feed- back does not occur at the level required for effective manage- ment. The rigid system of accountability to the laboratory directors diminishes the flexibility needed for operation of a responsive and innovative research program. h. "A long-term program designed to meet stated goals is missing and this is vital for any scientific venture." The ORD program has few clearly stated long-term strategies, specific to each Program Office, with easily identifiable objectives and goals. In the absence of long-term objectives and goals, the Agency's research and development resources seem excessively preoccupied with meeting short-term goals, some of which are restatements of goals not previously attai ned. i. "A false sense of control is generated by the highly structured mechanism for p1 a n n i n g." The highly structured planning and control system, which generates considerable activity, has promoted the feeling that something is happening that is of a positive nature. The widespread lack of clearly stated and agreed upon long-term objectives and goals, however, makes it difficult to determine whether the movement is positive, negative, or random in nature. j. "Relationships between the headquarters and field are strained at best; a state of frustration in the field staff is apparent." Considerable frustration is apparent in many of the organizational units below the *Assistant Administrator's office. In many cases, the individuals have resigned themselves to tolerating a work environment that is constantly, changing, but rarely for the better. 2. External constraints as perceived by the Office of Research and Development. a. "Enabling legislation is noncoherent and mandates a set of unbalanced and uncoordinated research objectives and timetables." 47 PAGENO="0304" 298 The enabling legislation for the Agency has been and continues to be viewed as noncoherent, mandating a set of unbalanced and uncoordinated research objectives and timetables. Since the enabling legislation has not and may not be changed in the near future, ORD has no real choice but to accept the situation that exists and strive to adjust its planning and operations accordingly. b. "The lack of an integrated approach to environmental pollution control in the Agency as a whole makes an integrated research and development program very difficult to form." Although some individuals view the Agency as not having an integrated approach to environmental pollution control, some progress has been made, and the use of approaches such as the pilot research committees offers the opportunity for developing an integrated research program with long-range objectives and goals as recommended in 1974. c. "Civil Service rules, parochial political pressures, and human nature combine as barriers to the simplification, assembly into `critical masses,' and logical organization of the research units which were inherited by EPA when it was created." Civil service rules, parochial political pressures, and human nature continue to be barriers to simplification, assembly into "critical masses," and logical organization of the research units, Of perhaps equal importance has been the failure to recognize that in the absence of a clearly recognizable research and development strategies specific for the Program Offices, the constraints of civil service rules, the influence of political pressures, and human nature will have substantial adverse impacts on the research program. An identifiable strategy with well thought out objectives and goals will go a long way toward minimizing the impact of factors that can push a reaction- oriented program, with ill-defined objectives and goals, off course. As addressed elsewhere in this report, civil service rules do adversely impact the research program, and suggestions for change are offered. However, in the absence of changes in the rules, the situation must be accepted and pLans developed within the constraints of the rules. Parochial political pressures have been, and probably will continue to be, brought to bear. However, it should be recognized that the Agency has strong political supporters, who can counter parochialism if they know that the Agency has a research program that is scientifically and managerially sound and programatically responsible with a plan for the future. Without question human nature may at times offer constraints, but, if properly directed, can also provide forward momentum. 48 PAGENO="0305" 299 d. "A level budget (except for the energy `roller coaster' of FY 74,75,76) prevents transitions which would be possible in a steady growth situation. An internal `roller coaster' budget appears to be particularly disruptive to individual projects." The level budgets of fiscal years 1974, 1975, and 1976 were given as the reason for the failure of the ORD planning and management progression. The level budget was said to prevent transitions that would be possible in a steady growth situation. Recent budgets have shown an increase; however, transitions do not appear to have occurred any more smoothly. A concern raised even more frequently than the shortage of funds is the restriction on the number of full-time employees. Although the impacts of the restriction are real, little has been or is likely to be accomplished by merely accepting the 0MB mandated personnel ceilings until they can be changed. Until changes are made, it would seem prudent to exercise greater care in the use of available personnel and to have a strategic plan for addition of personnel when vacancies do occur. Such a strategy for the management of personnel resources is an essential part of the total A9ency research and development plan and is the only way the personnel resources (as to number of individuals with specific types and levels of disciplinary training) can be matched to the long-term needs of the Agency. The 1974 letter report of the NAS/NRC Review Committee listed four major recommendations.* The recommendations have been implemented to varying degrees and, even where not fully implemented, still seem appropriate. Because they are still germane, each is reviewed below. 1. "The Environmental Research Objective Statement- Research Objective Achievement Plan-Program Area Manager-Program Element Direction-Program Assessment Group-system should be abolished. Responsibility for carrying out a program designed to meet the goals of the Office of Research and Development should be delegated directly to the National Environmental Research Center directors. Resources of manpower and money should be allocated directly to each National Environmental Research Center." *Ibid. page 98. 49 ~3-778 0 - 79 - 20 PAGENO="0306" 300' -- The planning and management system referred to has been largely abolished.. It has not been replaced by a system that is understandable to all parties involved; thus vestiges of the old system remain. The five Pilot Research Committees cover a portion of the ORD program and partially meet the planning function requirement. The National Environmental Research Centers and related field stations in existence in 1974 have since been separated into 15 individual laboratories, which report through four deputy assistant administrators to the Assistant Administrator for Research and Development. Although allocations of resources are made directly to the individual laboratories, there appear to be numerous strings attached which severely restrict the authority of the laboratory directors. 2. "The line reporting within the Office of Research and Development should be from the National Environmental Research Center directors to the Assistant Administrator. The Assistant Administrator should have a small staff to perform only staff functions and not to serve as a filter or layer through which the National Environmental Research Center directors report. This should develop into a simple pyramidal management system through which all direction, supervision, and evaluation is accomplished. This would, in effect, eliminate all layers or parallel management plans and result in a clear chain of authority from the individual researchers to the Assistant Administrator for Research and Development. The pyramid should decentralize quickly from Washington Headquarters to major field units. The Headquarter's staff should be trimmed appropriately and those necessary for "Washington liaison' activities clearly labeled. We did not have sufficient time to evaluate the role and position of the Washington Environmental Research Center. Such an evaluation should be made. `Because of the recent formation of the Agency by coalescence of disparate portions of other agencies, a particular need for intra-agency communication exists. To this end, a planned continuing rotation of field personnel into and back from a small Headquarters staff unit and between other units should be carried out. Short term, non-government talent should also be worked into this rotation system." 50 PAGENO="0307" 301 --The Washington staff of ORD is still quite large with a relatively large number of individuals serving in special staff roles and on numerous ad hoc committees. Clear chains of authority do not exist between TTi~ividual researchers and the Assistant Administrator for Research and Development; rather there are numerous filters through which information exchange must take place. Despite the largeness of the Washington staff, many appear overwhelmed by their work load, while others apparently fill slots for which there are no longer meaningful work assignments. Approximately 90% of the work load seems to be carried by one-half of the staff. Communication between Program Offices and the Office of Research and Development has been virtually non-existent in some areas. The five recently organized pilot research committees appear to have helped improve intra-agency communication and offer considerable promise for further improvement. Rotation of field personnel into and back from head- quarters has occurred to a limited extent, but more exchanges are needed. A limited number of short-term, nongovernment Individuals have rotated through the system, however more exchanges of this type are also needed. 3. "The function of the Assistant Administrator for Research and Development should be to assemble, analyze, and clearly define Agency research and development needs and objectives with the participation of the other Assistant Administrators and the National Environmental Research Center directors as the mechanism to develop goals, programs, and priorities. He should allocate objectives and the resources for their accomplishment to the National Environmental Research Centers. Once allocation is decided upon, the performer of the research or development should be linked directly to the user of the projected output for information exchange. "A performance evaluation should be set up to include continued inputs from users, and outside visiting committees reporting at a high level should be regularly employed. The system o,f visiting committees employed by the National Bureau of Standards should be studied for applicability. "A plan for a 3-5 year period to be revised at least annually should be developed." 51 PAGENO="0308" 302 --The Assistant Administrator for Research and Development has not systematically assembled, analyzed or clearly defined research and development needs and objectives. "The Research Outlook: 1978-1983", which has been published, and "The Research Outlook: 1979-1984", currently nearing completion, are perhaps the most definitive statements of research and development needs and objectives. However, neither document is an adequate statement of near-term, mid-term or long-term plans and objectives. Participatory discussions have apparently occurred with laboratories. Until initiation of the pilot research comm~ttees,most planning activities were carried out in headquarters with only limited and late stage input from the laboratories. With the advent of the pilot research committees, laboratory and Program Office input to near-term research planning has occurred in those research areas for which committees have been developed. This has had a positive impact on planning; however, in most cases where the laboratory director was not involved in the committee's activities, it has minimized the role of the laboratory director in the planning process. For a majority of the research programs, the laboratory directors and staff have been involved primarily in near-term planning and then most frequently at late stages of the budget cycle. In many cases the input has been fragmentary and spurious, i.e., "What would you and your people like to do next year?" Resource allocations (personnel and finances) are in a continuous state of flux. As expected in relation to the Federal budget system, changes are made up to the beginning of the current fiscal year, but frequently continue on throughout the year. The major certainty appears to be that change will take place. The laboratory directors apparently are given little authority for shifting resources within program areas and even less authority for shifting resources between program areas. This lack of flexibility, with continuous management from headquarters, appears to have had a negative impact on the productivity of the programs. EPA scientists, in many cases, are confronted with changes in program direction and level of effort with very short notice. Extramural projects have, in many cases, been treated as the most flexible portion of the system. Contracts that have been expanded or shifted in direction on very short notice have served to alienate substantial portions of the research community. Precipitous actions, discontinuation of programs, or shifting of program direction raises legitimate questions concerning the adequacy of Agency research and development planning. Precipitous increases of funds, although having associated moments of elation, are usually followed by a recognition that the time and personnel resources available do not allow careful selection of new contractors, resulting in projects that are less successful than they should be. 52 PAGENO="0309" 303 4. `Not only the changing nature of environmental problems but also the exigencies of the economy, suggest that it would be inadvisable to build up a large permanent staff. Rather, maintaining the necessary competence to monitor grant and contract work as needed would appear to be a prudent course. "A careful review of the contract and grant procedures should be undertaken." ..The Agency has not given adequate attention to developing a strategy for the implementation of Its research program, i.e., balance among intramural research, contracts, grants and interagency agreements. Although the mandated ceiling on numbers of personnel is. recognized, the Agency has not made adequate plans for living within that ceiling. To circumvent the personnel ceiling, contracted personnel are used on site at many laboratories to perform maintenance operations, thereby extending the work force. There are numerous individuals who are faced with a multitude of competing responsibilities: performing hands-on research; supervising technicians who directly assist them; preparing orders and monitoring the efforts of on-site contract personnel; soliciting and reviewing research grants and proposals; monitoring research being performed by contractors and grantees, either by personal visit or review of innumerable reports expected of the contractors and grantees; and participating in the preparation and review of criteria documents and related material. In some instances, there are experienced scientists and managers available who do an excellent job of balancing and meeting these competing demands. In a few instances, individuals, who have beeh unwilling to accept the demands placed on them, have retreated into their corners to do "their thing," i.e., perform specific research in line with their interests, and are content to let the system go on its own merry way. Although this has solved their immediate problem, it has increased the workload and iemand placed on their colleagues. In many cases, the demands are excessive in relation to the experience and training of the staff member, and one or more of the aspects of the job are performed poorly. The impact on both intramural and extramural research is apparent. The impact on the intramural program is discernible by the fact that many EPA scientists do not publish because they have performed relatively little research. A review of how selected grants and contracts were initiated and monitored suggests that, in some cases, the individuals involved did not have adequate experience or time to perform their assignments. A related and contributing factor has been the development of an "unwritten" set of procedures for promoting the use of grants rather than contracts because of the more cumbersome nature of the contract award process. 53 PAGENO="0310" 304 In summary, a careful review of contract and grant procedures is as much needed now as it was at the time of the NAS/NRC report. A key aspect of such a review should be the development of a strategy dealing with how much research can be appropriately performed in the Agency and how extramural work can best be performed. 54 PAGENO="0311" 305 VIII. COMMUNITY HEALTH AND ENVIRONMENTAL SURVEILLANCE SYSTEM (CHESS): AN INVESTIGATIVE REPORT A. Background of the CHESS Program The Community Health and Environmental Surveiflance System (CHESS) was initiated about 1970 and involved collection of data during the period 1970 to 1975. This research and surveillance program was designed to investigate the relationship, if any, between air pollution and health in human populations (up to a few thousand persons), studied at single contacts or followed for short periods of time (up to two years), for characterization of health status. These observations were coordinated with observations on air pollution in the environments of the study populations. The populations and areas included for study were selected to represent pairs or larger sets of contrasting exposures, for example, a `clean' and a "dirty" town or a series of several communities with a known or suspected substantial range of air pollution conditions. Most populations consisted of persons not previously known to have any special health problems, although some studies within CHESS were directed at groups defined by disease conditions, for example, known asthma patients. The program operated from 1970 to 1975 and resulted in a major publication in May 1974 (Health Consequences of Sulfur Oxide: A Report from CHESS, 197O-~l971). That publication fncTuded analysis and interpretation of the first two data collection years. Other smaller papers and presentations involved these and some later years' data. The major review in 1974 implicated sulfates, sulfuric acid, and sulfur dioxide as causing health effects, chiefly respiratory tract disease or disturbance of pulmonary function, at or near levels of these pollutants commonly considered "safe." That report was extensively reviewed by a number of individuals and groups and received both praise and criticism. In part because of some of the criticism, CHESS, in its original form, was discontinued. It was recommended, however that additional substantial efforts be made to optimally use the collected data. beyond those uses reported in 1974. Special features to be considered in further work were to include: (1) analysis of extensive data collected from 1973 to 1975 and not included in the 1974 report; (2) improvements of statistical data and analytic techniques; (3) assessment of validity of coded data and of extent of coding errors or other correctable problems in the data set; (4) increased objectivity i'n interpretation of findings; and (5) assessment of confidence range of estimates of pollution. 55 PAGENO="0312" 306 B. Findings of the Subgroup During the site visit in September 1978, the status of the CHESS program was reviewed and a summary follows. The mechanism for continuing work on CHESS is a contract from the EnvironS. mental Protection Agency to the University of North Carolina, Chapel Hill, principal investigator Dr. Carl Shy. This contract work is closely followed by members of the epidemiology division and the statistics unit of the Health Effects Research Laboratory, Environmental Protection Agency. Dr. Shy was formerly extensively involved with the CHESS project as a member of the epidemiology unit; he is now a member of the faculty, University of North Carolina. The plan is to review all of the CHESS data collected, for 1970 to 1975. The contract to the University was let in September 1977. To date the-re has been a major effort to validate the CHESS data sets. This was projected to require two years but is now expected to be completed about eight months ahead of schedule because special priority was given to the validation project. This has been accomplished in spite of a budget deletion of the funds planned for this purpose, thereby making It necessary to discontinue other work to meet this mandated task. The validation project is designed to identify discordances between manually recorded original data and tape recordings on exposure (pollution), outcome (health measures), and control demographic and confounding variables. It is being done very effectively under the direction of Mr. Gerald Nehls, Director of the Data Management Unit in the Health Effects Research Laboratory. It must be noted that any validation of these old data is now limited to validation of the previous coding and automating and not to any review of the correctness of initial observations of symptoms and other health effects. A standing committee has been created, reporting to Dr. Shy and supported under the research contract, to review all planned publications of the CHESS data. The committee presently consists of Dr. Warren Winkelstein (University of California), Dr. James Grizzle (University of North Carolina), and Dr. Michael Lebowitz (University of Arizona). This committee has just been funded, and its effectiveness cannot yet be judged. The membership seems appropriate, and the plan for a standing procedure for outside review is a useful move in response to criticism regarding objectivity of reporting. A report of a current analysis of a portion of the CHESS data from the Southeast region (Charlotte, North Carolina and Birmingham, Alabama) was presented to the site group by Ms. Shi- Ping Lan. The analysis and presentation indicated a high degree of statistical competence and good collaboration among Dr. Shy, Ms. Lan, and Dr. Hasselblad of the Health Effects Research Laboratory. The material presented will presumably be in a form for publication soon. A principal feature of the new analysis is more adequate use of the symptoms data from the health survey, employing a 5-level symptom scale rather than the dichotomy used in earlier analyses, 56 PAGENO="0313" 307 The information that can optimally be obtained from this Southeastern study is limited, however, because any possible effect of air pollution on the measured health indices Is lower by factors of 10 to 100 than effects of smoking or job exposure. Even though a pollution (intercity) association is found, it remains possible that this association is not causal but is due to a variable related to the stronger effects of smoking or job exposure or to other confounding variables for which no observations are available. While the acronym CHESS is understood to apply to the 1970 to 1975 group of studies, certain new work in progress follows the general outline of that program. The study most clearly conforming to that design is in four Utah communities, in which 1976 observations are being compared with former 1970 CHESS observations of chronic respiratory disease and of acute lower respiratory tract disease, as related to increasing 502 pollution in the region. A substantial change in the operation of CHESS and related studIes has been made in the past three years with a change in emphasis from in-house research to research grants and contracts. This appears to be a result, in part, of the extensive criticism of the previous CHESS program and is reflected in the entire activity of the Epidemiology Division. Only four professional researchers from a previous epidemiology staff of 15 remain in that division. Three new, young junior investigators have recently joined the division. The reduced staff is essentially completely occupied with their,duties as project officers on contracts and grants. The result of this change from intramural to extramural with regard to CHESS appears not to be obstructive and may offer certain advantages. C. Steps Taken. by EPA to Meet Brown Committee Ric ommendat ions Public Law 95-155, passed by the 95th Congress, mandated a review of and a report on "the findings and recommendations of the report to the House Committee on Science and Technology entitled `The Environmental Protection Agency's Research Program with Primary Emphasis on the Community Health and Environmental Surveillance System (CHESS): An Investigative Report.'" It was further specified that special attention be focused on ."procedural safeguards required to preserve scientific integrity of such research and to insure the reporting and use of such research in subsequent recom- mendations." 57 PAGENO="0314" 308 Although Chairman Brown emphasized the desirability of a positive attitude in the letter of transmittal of the Committee Report, the document impressed some members of the subgroup as often being hypercritical and demanding an approximation to perfection that is not obtainab'e in studies of human populations. The EPA has published a response to the recom~ mendations of the Investigative Committee in the EPA Research Outlook of March 1978. The report of this subgroup will address only those recommendations that deal with on-going activities related to CHESS or other epidemiological and bio- statistical work at HERL/RTP. Recommendations will be ident- ified by the numbers used in the Investigative Report and in the Agency's response. 3(a): EPA should publish an announcement regarding the limitations of the CHESS Monograph. 3(c): EPA should publish an addendum to the CHESS Monograph including most of the Investigative Report. Subgroup findings: It is believed that the EPA response covers these recommendations satisfactorily, although it is difficult to see how the response can be delivered to all holders of the CHESS Monograph. Most scientists, however, will be aware of the limitations of the data in this Monograph. 4(a): Legislation should be reexamined regarding unrealistic procedures and schedules. Subgroup findings: The legislative mandate for a study of air pollution and its effects on the Gulf Coast (Houston) area appears to require an unreasonably rapid approach to a very complex problem. The epidemiology group expressed an interest in investigating this situation in a systematic, planned fashion. They doubted that the mandated crash approach would be maximally productive but stated their intent to obtain as much valid data as possible. It is not known to what extent this legislative mandate was reexamined. No evidence was found at this level to indicate that reexamination was effective in producing any important changes. Current procedures referred to in the Agency's response in the EPA Research Outlook do not appear to be adequate to solve problems caused by unrealistic legislative mandates. 4(d): EPA should advise Congress if budgetary restric- tions will impact completion of major projects. Subgroup findings: Budget restrictions forced the statistical unit at HERL to discontinue other work to "clean" the data tapes for continued CHESS analyses. The response of the Administration and of Congress to this restriction is not known. While it did not affect CHESS, it must have had an adverse effect on other programs. 58 PAGENO="0315" 309 5: 0MB should be asked to develop procedures for prompt review of questionnaires. Subgroup findings: The Population Studies Division has found 0MB responsive to their need for quick approval of questionnaires. The subgroup supports the EPA position that its questionnaires for volunteers in research projects should not require submission to 0MB. 6(a): CHESS data analyses should be carried out only on data with high validity potential. Subgroup findings: Dr. Shy's group at the University of North Carolina and the epidemiologists and statisticians at HERL have reviewed the CHESS data and have decided which data sets warrant analysis for publication. 6(b): EPA should publish research in refereed journals in a timely fashion. 6(c): EPA should not publish large projects solely in monograph form. 6(d): EPA should not initiate projects for policy consideration unless they can be completed in a realistic time frame. Subgroup findings: Staff indicated their desire to see results published in scientific peer reviewed journals but emphasized their lack of time to do or report their research or the findings of contractors. It is reasonable to assume, however, that most grant recipients and contractors will publish their findings in appropri ate journals * It should be noted, however, that a document entitled "CHESS Biblio9raphy, December 1, 1977" lists, for the period 1/75 to 12/77, only one journal article, seven government publications, and ten EPA in-. house publications, plus three more In-house publications that are undated but whose authors or titles suggest that they belong in this time period. For 1977, the bibliography lists only.one government publication, which must have been planned well in advance of the Brown Committee report. It seems unlikely that the EPA responses to this recommendation can be properly assessed until the epidemiologic staff is increased to ~ size more commensurate with its duties. 7(a): EPA should strengthen the CHAMP aerometric and quality control programs. 7(b): EPA should shorten the time between data acquisi- tion and quality assurance analysis of data. 7(c): EPA should stop employing development stage instruments before qualification testing. 7(d): EPA should not use laboratory models of instruments in the field until they have been field checked and operating personnel trained. 59 PAGENO="0316" 310 7(e): EPA should reevaluate the opening of the CHAMP operations contract to competition. Subgroup findings: CHAMP is no longer at HERL. We were informed that it no longer exists as an identifiable unit separate from other monitoring activities. 7(f): EPA research and monitoring personnel should closely coordinate regarding chemical species. Subgroup findings: Coordination of CHAMP with health effects personnel is now potentially more difficult because of the transfer of the responsibilities of CHAMP to another laboratory. It is still too early to tell whether the transfer will help by strengthening this type of monitoring activity or will hinder the accomplishment of the Agencys mission by impeding coordination. 10(a): An interdisciplinary ~task force should draw up an integrated air epidemiology exposure assessment program plan for EPA. Subgroup findings: There is a desire for an advisory group not only to meet this recommendation for assessing health effects of air pollution but also to provide consultation for other epidemiologic studies, both intra- and extramural. 10(c): EPA should have epidemiological questiQnnaires and panel selection criteria approved by peer groups. Subgroup findings: Aside from a comparison of self- admi nistered versus interviewer-administered questionnaires, the work related to this recommendation is limited to the information that can be gathered from the extensive analyses *of CHESS data being carried out by Dr. Shy. The panel data are not scheduled for analysis. Planning for a second round of CHESS or for investigation of air pollution "episodes" was not mentioned. It is difficult to see how very much can be done along this line with the limited staff. It seems reasonable to delay plann~ing for a second round of CHESS until the current analyses are completed. 6i) PAGENO="0317" 311 A?~ENDIX A UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHiNGTON. D.C. 20460 JUL 12 1978 THE ADMINISTRATOR TO: Dr. Emil M. Mrak Chairman Executive Committee, Science Advisory Board THRU: Dr. Richard H. Dowd SUBJECT: Charge to the Science Advisory Board' s Health Effects Research Review Group The Authorization Act of 1978 for Research and Development, PL 95-155, requires that a special evaluation report on the Agency's health effects research efforts be prepared by the Science~ Advisory Board (SAB). The Act specifically outlines whatis expected to be included in the report regarding your assessment of our health effects rés~arch programs, and the procedures for the conduct,. review, reporting and. use of such research. To delineate the Congress's charge more sharply, I urge the Study Group to define health effects research to include all planned activities, col- lection and analyses of data done within the Agency for the purpose of adding to the scientific basis for understanding the effects of environmental factors on human health. This definition would include those activities within the Agency which may be used to assess human risk, and which support standard setting and regulatory decisions, and any activity which gathers new knowledge about human health, or improves our understanding of human health either directly or which can be used to extrapolate to human health impacts. I am happy to hear that .Dr. James Whittenberger and Dr. Roger McClellan will chair and co-chair this review group. I can assure-you that your assessment of the Agency's açtivitie~s'i within the scope of this definition will be apprecj.ated and that you will have our full cooperation in this endeavor. A-i PAGENO="0318" 312 PUBLIC LAW 95.455.-NOV. 8, 1977 91 STAT. 1257 Public Law 95.455 95th Congress An Act To authorize appropriations for activities of the Pnvironruenrtai I'roteetion _~N!~8.i9i!.~ Agency, arid for other purposes. (l4.R. 51011 lie if enacted by the Senate and house of Representatives of the United States 0/ America in Con~p'ess a.~.wnabkd, That this Act inray Environnnentai be cited as the "Envirorunicntal Research, 1)cvcloprnent., and Demon- Research, stratiori Aut horization Act of 1978". Development, Sze. 2. (a) `flare are authorized to be appropriated to the Environ- mental Piotectioni Agency for en vironrnenrtal research, development, AAct and demonstration rut ivitics for fiscal year 1978- of 1978. (1~ $92,500,000 for water quality activities authorized under the 1'edeiaI Wake Pollution Control Act of which- 33 USC 1251 (A) $25,200,000 is for the health and Ecological Efleets note. program; (B) $9,300,000 is for the Industrial Processes program; (C) $6,069,000 is for the Monitoring and Technical Support program; (1.)) $22,300,000 is for the Public Sector Activities pro- grain; and (E) $29,631,000 is for the Energy progriuni. (2) $10,800,000 for activities authorized under the Federal Insecticide, Fungicide, arid Rodenticide Act, iii the Health arid 7 USC 136 note. Ecological Eltect s program. (3~) $16,000,000 for water supply activities authorized un(ler the Safe Drinking Water Act, in the Public Sector program. 42 Usc 300f (4) $8,200,000 for toxic substance control activities autlroriztd note. under the Toxic Substances Control Act, in the Health and Eco- 15 USC 2601 logical Effects progranri. note. (5) $830,000 for radiation activities authorized under the Public Health Act, in the health and Ecological Effects program. 42 USc 201 hole. (6) $35,000,000 for air quality activities authorized under the Clean Air Act., which shitill be in addition to funds previously 42 USC 1857 authorized iii the Clean Air Act Arriendmnents of 1977 (Public Law note. 95-OS), so that the total amount, authorized for such activities in Ante, p. 685. fiscal year 1078 is $155,000,000, of which-- (A) $86,000,000 is for the I [enlth and Ecological I'~tfcets program; (B) $11,000,000 is for tire Monitoring and `rechnical Sup- port program; (C) $7,000,000 is for the Industrial Processes program; and (D) $101,000,000 is for the Energy program. (7) $81,273,000 for interdisciplinary activities, of which- (A) $9,230,000 is for the I fealth and Ecological `Effects pro'ram; (~) $6,066,000 is for tire Industrial Processes program; (C) $1,509,000 is for the Public Sector Activities pi'ogramn; and (~) $14,378,000 is for the Monitoring arid Technical Sup. port program. A-2 PAGENO="0319" 313 91 STAT. 1258 PUBLIC LAW 95~-155-..NOV. 8, 1977 (b) In addition tb any otltei SItIOS ahltItOliZCd by this section Or by other provisions of law- 1) t here are ant horizid to be flpprO~)nated to t he Adtnini~- tiator of the Enviroinnetital Protect on Agency for hscal year 1978, $10,000,000 for long-term research and (leVelOprnCflt In accordance with Section 6 of this Act; (`2) t lute 1111 tilt 1)Ol'izi(t to In ;l~)proprlated to the A(lIlllfllS- trator, for fiscal year 1978, $2,000,000 for training of health sd- (lit ists 11(0(10(1 for (fl V.i rotutitental I'(50fl icli and (Ic V(IoJ)ttient Ill dwl(ls where there are national shortages of t rained petsontid and (3) there arc authorized to be approplIat((l to the AdminiStra- tor for fiscal year 1978, ~3000,00() to 11111)1(Ilteflt. the st tidY nut ho~- ized in section 103(d) of the Clean Air Act AnIeIi(hu)etltS of 1977 Ante, p. 687. (Public Law 95-95). Appropriation (c) There is atithotized to Ito appropriated to the AdiiuiIiistrat~)r authorization. $19,000,000 for fiscal year 1978 for program iminagetnent and support ielated to onvirotnittental itsearch nn(l (kveioptnent.. Transferof funds, (d) No funds titay be trattsfeirid front any particular categoty restriction, listed in subsection (a) or (b) to any other category or categories listed in either stiohu subsection if tite total of the funds so transferred front that I)atticlthttr (Ittogoty ~voitid exceed 10 Per ctntiiin t.hiei'eof, and no funds nay be t i'ansferred to any particular category listed ill subsection (a) or (b) fiotu any other category or categories listed In either such sui)section if the total of the funds so transferred to that particular category would ~cecd 10 per cent nut thereof, unless- (1) a period of thirty legislative (lays has i)ass((1 after the Administrator of t hue En vi toit ii toittal I `roto('t ion Agency or his designee has t ransniitted to the Spoako't' of the I louse of lhpre- sentatives and to the President of the Senate a written report containing a full and coitujtlete st atenuent concerning the nature oI the tIttlis fti al1(l tilt reason there for. or (2) eadi coniiiiittee of the I loitse of 1~eI)reSefltatives and t~te Senate havitig jurisdiction over the subject. matter involved, before the expirat ion of such period has transmitted to the Admin- istratot written notice to the elkct that such (`otnmittee has no objection to the P1oI)os(d act ion, Ssc. 3. Appropriations made j)tllstliint to the authority provided in section `2 of tins Act shall ren~ain available f9r oI)ligation for expenditure, or for obligation and expenditure, for such period or periods as may be specified in the Acts making sneh appropriations Budget Ssc. 4. `Ihe Adiuinistratoi' of the En'jtoninetutal Protection Agency, projections. in each annual revision of the five-year plan tiansnuit ted to the Con- 42 4361a. gross under section 5 of Public Law 94-475, shall include budget pro- 42 4361. jectioius for a "no-growt hi" budget, for a °nio(Iirate-growt hi" budget, and for a "high-growth" budget. In addition, each stith annual revi- sion shall include a detailed explanation of the relationship of each budget I)i0Je~tion to the existing laws which authorize the Admuuinis- trat ion's. environnuenta I resenich, development, and denionst ration programs. Public sector Ssc. 5. (a) The Administrator of the En~'irontuuental Protection agencies, grants. Agency shall offer grants to public sector agencies for tim purposes (1) assisting in the develo1,nient and demonstration (incl~d- ing construction) of any project which will demonstrate a new or unproved method, approach, or technology for l)roviding a dependably safe supply of drinking water to the public; and A- 3 0 PAGENO="0320" 314 PUBLIC LAW 95-.155-..-NOV. 8, 1977 91 STAT. 1259 (2) assisting in the development and demonstration (includ- ing construction) of any })roj(ct which will investigate and dciii- onstrato health and conservation implications involved in the reclamation, recycling, and reuse of wastewaters for drink- ing and the processes and methods for the j)iepaiUtiOfl of safe and acceptable (I tinking water. (li) Giants made by the Administrator under this section shall be Grants, subject to the following limitations: lim~tat~ons. (1) Grants under this section shall not exceed 66% P~ centurn of the total cost of construction of any facility and 75 per cenlum of any other costs, as determined by the Administrator. (2) Grants under this section shall not he made for any proj- ect involving the construction or modification of any facilities for any public water system in a State unless such project has been approved by the State agency (barged with (lie responsi- bility for safety of drinking water (or if there is no such agency in a State, by the State health authority). (3) Grants tinder this section shall not be made for any proj- ect unless th~ Administrator determines, after consultation, that such project will serve a useful purpose relating to the (levelop- meat, and demonstration of new or improved techniques. methods, or technologies for the provision of safe water to the public fm drinking. (e) There are authorized to be appropriated for the 1)U1POSCS of this section $25,000,000 for fiscal year 1918. Szc. 6. (a) The Administrator of the Environmental Protection Research and Agency shall estabhisJi a separately i(lentif:ecl proginul to conduct con- development tinning and long-term environmental research and development. pro~am. Unless otherwise specified by law, at least 15 P~' centuni of any funds 42 SC 4.363. appropriated to the A dministrator for environmentit I resea icli and development under section 2(a) of this Act or under any other Act shall be allocated for long-term environ mental research and devel- opment. under this sect ion. (b) The Administrator, after consultation with tIme Science Advisory Report to Board, shall submit to the President and the Congress a ie1x~it (`Ofl- President and corning the desirability and feasibility of establishing a naional Congress. environmental laboratory, or a system of such laboratories, to assume or su l)l)lemmment. the long-term envi io,mmental resea mcli functions crc- ated by subsection (a.) of this section. Such report shall be submitted Contents. on or before March 31, 1978, and shall include findings and recoin- macmint ions concerning- (1) specific. types of research to be. carried out by such labora- tory or laboratories; (2) the coordinat ion and integration of research to be con- ducted by such laboratory oi- laboratories with research con(lucted by existing F'e(leral ci other ieaenrtlm fa(ilit ies (3) methods for assuring continuing long-range funding for such laboratory or laborntom-ies ; mind (4) other administrative or legislative actions necessary to facilitate the establishment of such laboratory or laboratories. Szc. 7. (a) The Administrator of the Environmental Protection 42 Usc 4364. Agency shall assure that the expenditure of any funds appropriated pursuant to this Act or any other provision of law for envi m'onment ~1 research and (levelnpmnenmt m(late(l (cm regulatory l)mOdria in ~c Iv't ies shall be coordinated with and reflect the research needs and priorities A-4 PAGENO="0321" 315 91 STAT. 1260 PUBLIC LAW 95-155--..NOV. 8, 1977 of the program offices, as ~veIl as the overall research needs and priori- ties of the Agency, including those defined in the live.year research plan. Progtam offices. (b) For purposes of subsection (a), the appropriate prograrli offices are-S (1) the Office of Air and Waste Management, for air quality activities; (2) the Office of Water and Hazardous Materials, for water quality activities and water supply activities; (3) the 0111cc of Pesticides, for cnvironlnent4tl effects of pesticides; (4) the Office of Solid Waste, for solid waste activities; (5) the 0111cc of Toxic Substances, for toxic substance activities; (0) the Office of Radiation Programs, for radiation activities; and (7) the Office of Noise Abatement and Control, for noise activities. Report to (c) The Administrator shall submit to the President and the Con. President and gress a report concerning the most. apl)ropriate means of assuring, on Congress. a continuing l,asis, that the research efforts of the Agency reflect the needs and priorities of the regulatory program offices, while main- taining a high level of scientific quality.. Such report shall be submitted * on or before March 31, 1978. Science Advisory Sac. 8. (a) The Administrator of the Environmental Protection Board~ Agency shall establish a Science Advisory Board which shall provide Establishment, such scientific advice as the A(lminist rator requests.. 42 USC 4365. (b) Such Board shall he composed of at least nine mernbei's, one of Membership. ~s'hom shall be designated Chairman, and shall meet at such times and lilaces as may be designated by the Chairman of the Board in const~l- tation with lhc Administrator. Each member of the Board shall be qualified by education, training, and exl)erience to evaluate scientific and technical information on matters referred to the Board under this section. (c) In ad(lit ion to providing scientific advice when requested by the Administrator under subsection (a), the Board shall review ai~d comm~uit on the Administration's five-year plan for environmental research, development, and demonstration l)ro%?ided for by section 5 42 USC 4361. of Public Law 94-475 and on each annual revision thereof. Such review and comment shall be transmitted t.o the Congress by the Administrator, together with his comments thereon, at the time of the transmission to the Congress of the annual revision involved. Report to (d) `I'hc Board shall conduct a review of and submit a report to the Administrator, Administrator, the President., and the Congress, not later than ~esid:nt, and October 1, 1978, concerning- g . (1) the health effects research authorized by this Act and other laws; (2) the procedures generally used in the conduct of such research; (8) the internal and external reporting of the results of such research; (4) the review proce(lures for such research and results; (5) the procedures by which such results arc used in intermial and extoninl recomnimmendations on policy, regulations, and legisla- tion; and (6) the findings an(l recomrnen(lationS of the i'epoi't. to the Itouso Committee on Science and `I'echnology entitled "The A-5 43-778 0 - 79 - 21 PAGENO="0322" 316 PUBLIC LAW 95455-NOV. 8, 1977 91 STAT. 1261 Envi ronmeittal Protect ion Agency's Research Prof~I'aIfl with l)1'JIflttiY eniplutsis on the Continunity I Icaith an(1 Environmental Survciliaiicc System (CI I ESS) : An Iii vestigat I ye Report". `I'hc review slial I focus special attention on the pi'OcC(tIii'ttl safeguards I'equi 1(51 to ~)tC.S('I'Ve t lit' S('iPnt ific integrity of such i't'search and to insure reporting un(l use of t he results of such research in subsequent reconunendations. The report shall mel tide specific I'CCOmmefl(Iflt ions Ofl I lie results of I he rt'vi('W to ensure scient die integrity throughout he Agency's health I fleets research, review, reporting, and recoin- men(lat 011 l)1'~('es5. (e) (1) The Administrator, at the time any 1)101)05(51 criteria docu- isient, Stan(lflJ(l, limitation, or regulation under the (lean Air Act, the 42 Usc 1857 Federal Water I `ol hit ion Cont tol A('t, the Hesouu rce, Conservation and note. 1{ecovei'y Act of 197(, tin' Noise Control Act, the Toxic Substances 33 USC 1251 (`out tol 1.t, or the Safe J)rinking `Water Act, or under any. other note. authority of the Administrator, is provi(led to any other Federal 42 usc 6901 agency for formal review and comment, shall make available to the 42 UsC 4901 Board such ~)roposecl criteria document, standard, limitation, ~ note regulation, toget het with relevant scientific and technical information is usc 2601 in the pOSSt'SsiOfl of the Environmental Protection Agency on which note. the proposed action is based. 42 usc soor (`2) The Board may make available to the Administrator, within note. the time s1)ecifled by the Administrator, its advice and comments on the adequacy of the scientific an(1 technical basis of the proposed criteria (loctunent, standa id, ii iiiit ~tt ion, or regulation, together with any pertinent information in the Board's possession. (f) in preparing su(ll advice 811(1 comments, the Board Shall avail itself of the technical and scientific cltl)al)ilitie.S of any Federal agency, including (he Environmental Protection Agency nfl(l any national CflViIOi)111C11t81 laI,oratorics. (g) The 13081(1 is IiUthOl1ZV(l to constitute such member committees Member and investigative Panels as the Administrator and the Board find committees and necessary to carry out this section. Each such meinl~er committee 01' investigative investigative panel shall be chaired by a member of the Board. panels. (Ii) (1) Upon the recommendation of the Board, the Administrator Secretary, shall appoint a sectetaiy, and stich ot her enij)iOVe(5 as deemed neces- appointment. sa ry to exercise 1111(1 fulfill the Boa rd's jo~t'e1~ and responsibilities. The compensation of all employees appointed tinder this palaglapli shall be fixetl in aC(Ol(llliRe wit Ii (118 ptei 51 and subchapter III of chapter 53 of tit it' iS of the 1'uite(l States (`ode. S USC 5iOi, (`2) Members of the Board niav be compensated at a rate to be fixed 5331. by the President. butt ziot. in excess of the maximum rate of P8Y for grade. (~S-l8, as provided in the General Schedule under section 5339 of title S of the United States Code. 5 USC 5332 note (i) lit carrying out the functions assigned by this section, the Board shall consult and coordinate its activities with the Scientific Advisory Panel est aid islieci by the Admmist rator pursuant to sect ion 25 (d) of the Fedemal insecticide, Fungicide, anti Rodenticide Act, as anleiRled. 7 USC 136w. Sac. 9. (a) `l'hc Administiator of the Environmental Protection 42 USC 4366. Agency, in consult at ion and coopeint ion wit Ii the hea(lS of ot liet' Fed- ermil agencies, shall take such actions on a coid inning basis as may be fleceSSar.y 01 apj)1O[)I'ittC- (1) to ident ~ *env i toninental i~esca ccli, (levelopment, and demonst ration act ivitios, within and outside the Fe(leral Govern- A-6 PAGENO="0323" 317 91 STAT. 1262 PUBLIC LAW 95-.155-.-NOV. 8, 1977 meat2 which may need to be tisore effectively cLvdinnted in order to m inutnizo unneee.ssary (1(11)1 icatiOn of prog~iuns, l)i0JeCtS, and research facilities; (2) to determine the steps which might be taken under existing law, by him and by the bends of 511(11 ot h(~i age~icies, to ae*unplith ~r promote such coordination, and to provide for or encourage the taking of such steps; and (3) to determine the additional legislative actions which would be needed to assure SUCh coor(Iination to th~ iiittXliflUIfl extent possible. Report. `rho Administrator shall inclu(le in each annual revision of tile five- 42 USC 4361. year plait provided for by section 5 of I'nblie Law 94-475 a full and complete report on the actions taken and ticterniinat ions 11111(10 during the preceding year under this subsection, and may submit internn )`eI)OitS on such actions and (letermuilat iOflS at such other times as ho decots appropriate. (b) `rile Administrator of the Environmental Protection Agency shall coordinate eitvi ronmental research, development, ititti demon- stration programs of such Agency with the heads of other Federal agencies in Oi(k'i to iflifli 01 ize unnecessary (lu~)1 ucat ion of programs, 1)1010(15, 1111(1 resciuch faci lit as. (c) (1) In order to 11iO111(>tO the coordination of environmental research and development activities, anti to assure that the action taken and methods used (under subsect ion (a) and otherwise) to bring about s''ch (OOI(lifliltiOIL Will ls~ QS (`fleet iv(' itS possible for that puipose, the Council on Environmental Quality in consult ation ~~`ithi the 0111cc of Science ii mid Technology Policy sludl p1001 pt 13' undeitako an(l early out. a joint study of all aspects of (he coordi imat ion of en viionniental Report to i'esearcli afl(l (levelOpnleflt. The (`hum oman of the Council shall pvc- I'reeident and pare a report on the results of such st tidy, toget hici with such recoin- ~oftgre8s. mentlations (including legislative recoinmnendittions) as he deems rec~omrneoda. 1, pp~op~u~t(', and sh~tl I Sii1)illit. such report to (lie President and the lions Congress not. later than May 81, 1978. Presidential (2) Not. later than September 30, 1978, the President. shall report report to to the Congress On Stel)S he has taken to inil)lenlent the recomnmentla- Congress. tions include(L ill the report. under paragraph (1), including any icc- Onhmuen(hat ions he may have for legislation. 42 USC 4361b. S}~. 10. The Administrator of the Environmental Protect ion Agency sliitll ifli,pleiiielit the iecoiiirneittlat ions of the report, 1)101)11 red for the house Comniittee on Science and Technology entitled "i'hte Environ- mental Protection Agency Research Program with l)tilflitiY eniphtasis on the Community I Lea it h and Environimiental Surveillance System (ChESS) An investigative Report", unless for any specific ice- omnmen(lation he (leteimnineS (1) that such recommendation has been implemented, (2) thiiit umiiplemiieittatioii of such ieeomnienda( ion would not enhance the quality of the research, or (3) that implementation of such recomnmnentlat ion ~vil 1 10(1 hire funding which is not a vii ilable. Wheic such funding is not available, the Admn joist rater slia II request the 1e(Iu ired authiorizat jolt or appropriat ion for su(hi i lnl)lehmientat ion. The Administrator shall report the status of such implementation in each annual revision of tho five-year plan transmitted to the Con- gre~s immider sect jolt iS of Ptibli~ 1411w 9-1-475. I'er.onnel S~c. 11. The Admit mist rat or of the Environmental Protect ion Agency I~~~fll0ns, shall increase the number of personnel positions in the Health and Ecological Effects program to 862 positions for fiscal year 1978. A- 7 PAGENO="0324" 318 PUBLIC LAW 95-155---NOV. 8, 1977 91 STAT. 1263 Sno. 12. (a) Each officer or employee of the Environmental Protec- Annual tion Agency who- statement, filing. (1) performs any function or duty under this Act; and 42 Usc 4367. (2) has any known financial interest in any person who applies for or receives grants, contracts, or other forms of financial assist- ance under this Act, shall, beginning on February 1, 1978, annually file with the Admin- istrator a written statement concerning all such interests held by such officer or employee during the preceding calendar year. Such statement shall be available to the public. (b) `rue Administrator shall- (1) act within ninety days after the date of enactment of this Act- (A) to define the term "known financial interest" for pur- poses of subsection (a) of this section; and (B) to establish the methods by which the requirement to file written statements specified in subsection (a) of this sec- .tion will be monitored and enforced, including appropriate provision for the filing by such ollicers and employees of such statements and the review by the Administrator of such state- ments; and (2) report to the Congress on June 1 of each calendar year with Report to respect to such disclosures and the actions taken in regard thereto Congress. during the preceding calendar year. (c) In the. rules prescribed under subsection (b) of this section, the Administrator may identify specific positions of a nonpolicymaking nature within the Administration and provide that officers or employ- ees occupying such positions shall be exempt from the requirements of this section. (d) Any officer or employee who is subject to, and knowingly vio- Violation, Iate.s, this section, shall be fined not more than $2,500 or irnprisoned penalty. not more than one year, or both. Szc. 13. It is the national policy that to the maximum extent possible Paperwork the procedures utilized for implementation of this Act shall encourage minimization, the drastic minimization of paperwork. encouragement. Approved November 8, 1977. LEGISLATIVE_HISTORY: HOUSE REPORTS: No. 95-157 (Comm. on Science and Technology) and No. 95-722 (Comm. of Conference). SENATE REPORT No. 95-188 accompanying S. 1417 (Comm. on Environment and Public Works). CONGRESSIONAL RECORD. Vol. 123 (1977): Apr. 19, considered and passed House. May 27. considered and passed Senate. amended, in lieu of S. 1417. Oct. 20. Senate agreed to conference report. Oct. 25, House agreed to conference report. A-8 PAGENO="0325" 319 Appendix B COMMITTEE MEMBERS AND CONSULTANTS 1. Subcommittee Core Members Chairman: Dr. James L. Whittenberger Professor of Physiology School of Public Health Harvard University Cochairman: Dr. Roger 0. McClellan Director of Inhalation Toxicology Research Institute Lovelace Foundation Members: Dr. Peter Bloomfield Associate Professor Department of Statistics Princeton University Dr. George W. Comstock Professor of Epidemiology Johns Hopkins Training Center Dr. Morton Corn Professor of Industrial Health and Air Engineering Graduate School of Public Health University of Pittsburgh Dr. Julius E. Johnson Consultant Dow Chemical Company Dr. Wendell Kilgore Professor of Toxicology Department of Environmental Toxicology University of California at Davis Dr. Robert A. Neal Director, Center in Toxicology Department of Biochemistry Vanderbilt Medical School A~.9 PAGENO="0326" 320 Dr. Gerard A. Rohlich Professor of Environmental Engi neeri ng, Department of Civil Engineering, University of Texas SAB Staff Officer: Dr. Frode Ulvedal Supervisory Toxicologist Office of Research and Development Environmental Protection Agency 2. Consultants Dr. Edwin Lennette, BiomedicalLabs, Cali- fornia State Department of Health expertise: microbiology, virology Dr. Jeanne Manson, Kettering Laboratory University of Cincinnati expert i se: reproduction, teratology Dr. Sol M. Michaelson, Professor of Radiation Biology and Biophysics, University of Rochester expertise: non-ionizing radiation Dr. Steven M. Horvath, Director, Institute of Environmental Stress, University of California expertise: pulmonary physiology, inhalation toxicology Dr. George Hutchinson, Professor of Epidemi- ology, Harvard School of Public Health expertise: epidemiology, m i crob i 01 ogy Dr. James G. Fox, Director, Laboratory of Animal Medicine, Massachusetts Institute of Technology expertise: laboratory animal care and facilities ~r. Jennifer L. Kelsey, Associate Professor of Epidemiology, Department of Epidemiology and Public Health, Yale University School of Medicine expertise: epidemiology of chronic disease Dr. Ralph C. Buncher, University of Cincinnati Medical Center expertise: epidemiology A-lO PAGENO="0327" 321 APPENDIX C MEETING AND TRAVEL SCHEDULE FOR HERRG LOCATION PARTICIPANTS 21 June 78 13-14 July 78 2O~.2l July 78 23 Aug. 78 25 Aug 78 Preliminary meeting, with Dr. Hueter, HER L/RTP Public meeting, Washington, D.C. Envi ronmental Research Lab Duluth, Minn. Office of Water & Waste Management Washington, D.C. Office of Toxic Substances Washington, D.C. Dr. Whittenberger Dr. Ulvedal HERRG Dr. McClellan Dr. Kilgore Dr. Ulvedal Dr. Rohlich Dr. Neal Dr. Johnson Dr. Ulvedal Dr. Neal Dr. Kilgore Dr. Johnson Dr. Ulvedal 25-27 Sept. 78 Health Effects Research Lab Research Triangle Park, N.C. HERRG and Dr. Manson Dr. Michaelson Dr. Horvath Dr. Hutchinson Dr. Fox Dr. Kelsey Dr. Ul vedal 28 Sept. 78 5-6 Oct. 78 16-18 Oct. 78 Preliminary Mtg. with Dr. Garner HERL/Ci ncinnati Envi ronmental Research Lab Gulf Breeze, Fla. Health Effects Research Lab Cincinnat.~, Ohio Dr. McClellan Dr. Ulvedal Dr. Whittenberger Dr. Kilgore Dr. Ulvedal HERRG and Dr. Lennette Dr. Hutchinson Dr. Fox Dr. Buncher 19 Oct. 1978 Health Effects Research Lab. Field Station Wenatchee, Wash. A-li Dr. McClellan Dr. Johnson Dr. Kilgore Dr. Ulvedal DATE PAGENO="0328" 322 DATE LOCATION PARTICIPANTS 24 Oct. 78 Office of Air, Dr. Whittenberger Noise, & Radiation Dr. Corn Dr. Bloomfield Dr. Ulvedal 26 Oct. 78 `Environmental Dr. Whittenberger Research Lab. Dr. Lennette Narragansett, R.I. Dr. Ulvedal 27 Oct. 78 Health Effects Dr. Whittenberger Research Lab Dr. Lennette Field Station Dr. Ulvedal W. Kingston, R.I. 30 Oct. 78 Office of Planning Dr. McClellan and Management Dr. Ulvedal Washington, D.C. 8 Nov. 78 Region I Dr. Whittenberger Boston, Mass. Dr. Ulvedal 9 Nov. 78 Environmental Mon- Dr. McClellan itoring & Support Dr. Ulvedal Laboratory, Las Vegas, Nev. 13-14 Nov. 78 Public Meeting HERRG Washington, D.C. 13 Nov. 78 Office of Planning Dr. Corn and Management Dr. McClellan Washington, D.C. Dr. Johnson Dr. Bloomfield 13 Nov. 78 Office of Research Dr. Whittenberger and Development Dr. Kilgore Washington, D.C. Dr. Neal A-12 PAGENO="0329" 323 APPENDIX D PRINCiPAL EPA PERSONNEL PROVIDING INFORMATION TO HERRG * Interviewed + Provided written information Office of the Administrator Douglas N. Costle*+ Administrator Dr. Richard Dowd* Science Policy Advisor to the Administrator Staff Director, Science Advisory Board Dr. Toby Clark*+ Special Assistant to the Administrator Regional Offices William R. Adams, Jr.* Regional Administrator, Region I Dr. Richard Keppler* Director, ORD, Region I Office of General Counsel James C. Nelson*+ Attorney Advisor John W. Lyon* Attorney Edward Gray* Deputy Associate General Counsel for Program Support Office of Legislation Marianne Thatcher* Congressional Liaison Specialist Alice Whlte+ Legislative Reference Specialist Office of International Activities Jack E. Thompson+ Director, International Organizations and Western Hemisphere Division A-13 PAGENO="0330" 324 Office of International Activities (Continued) Thomas Lepine+ Chief, Scientific Activities Overseas Branch Office of Planning and Management Roy N. Gamse* Deputy Assistant Administrator for Planning and Evaluation Frans J. Kok* Director, Economic Analysis Division Marian Mlay* DirectOr, Program Evaluation Division Matthew Pilzys* Associate Deputy Assistant Administrator for Resource Management Raymond A Pugh*+ Director, Budget Operations Division Donald Hambric+ Chief, Cost Review and Policy Branch Contract Management Division (CMD) Vincent Jay+ Chief, Interagency Agreements Branch, CMD Carlene Foushee+ Grants Specialist, Grants Division Office of Water and Waste Management Thomas C. Jorling* Assistant Administrator for Water and Waste Management Allen Cywin*+ Senior Science Advisor Swep T. Davis* Deputy Assistant Administrator for Water Planning and Standards Albert J. Erickson* Associate Deputy Assistant Administrator for Water Planning and Standards John T. Rhett* Deputy Assistant Administrator for Water Program Operations Henry L. Longest* Associate Deputy Administrator for Water Program Operations A-14 * PAGENO="0331" 325 Office of Water and Waste Management (Continued) Kenneth Mackenthun* Director, Criteria and Standards Division Gary N. Dietrich* Direcotr, Office of Program and Management Operations Victor J. Kimm* Deputy Assistant Administrator for Drinking Water John P. Lehman* Director, Hazardous Waste Management Division Joseph Cotruvo*+ Director, Criteria and Standards Division Office of Drinking Water Shelly Wiiliamson*+ Epidemiologist Office of Air, Noise and Radiation David G. Hawkins* Assistant Administrator for Air, Noise and Radiation Rudolph N. Marrazzo* Science Assistant to the Deputy Assistant Administrator for Noise Abatement and Control William A. Mills* Director, Radiation Criteria and Standards Division Acting Deputy Assistant Administrator for Radiation Programs Walter C. Barber, Jr.* Deputy Assistant Administrator for Air Quality Planning and St andards John O$Connor*+ Strategies and Air Standards Division Joseph Padgett* Director, Strategies and Standards Division Michael P. Walsh* Deputy Assistant Administrator for Mobile Source Air Pollution Control Stan Blacker* Special Assistant to DAA for Mobile Source Air Pollution Control A.15 PAGENO="0332" 326 Office of Toxic Substances Steven D. Jellinek* Assistant Administrator for Toxic Substances Warren R. Muir* Deputy Assistant Administrator for Testing and Evaluation John DeKaney* Deputy Assistant Administrator for Chemical Control Edwin L. Johnson* Deputy Assistant Administrator for Pesticide Programs James M. Conlon* Associate Deputy Assistant Administrator for Pesticide Programs William S. Murray*+ Director, Technical Services Division Jack Griffith* Chief, Human Effects Monitoring Branch, Technical Services Division Don Barnes+ Special Assistant to the Assistant Administrator for Toxic Substances Norbert Page* Director, Health Review Division James R. Beall* Toxicologist, Health Review Division David Gould* Toxicologist, Health Review Division David Anderson* Biochemist, Health Review Division Carl Morris* Pharmacologist, Health Review Division Office of Research and Development Stephen J. Gage*+ Assistant Administrator for Research and Development Sam Rondberg*+ Director, Office of Planning and Review Dennis Tirpak+ Special Assistant to AA for Research and Development A-16 PAGENO="0333" 327 Office of Research and Development (Cont.) Randall W. Shobe+ Director, Technical Information Division Robert W. Lane*+ Special Assistant to AA for Research and Development Delbert Barth* Deputy Assistant Administrator for Health & Ecological Effects William S. Murray* Associate Deputy Assistant Administrator for Health & Ecological Effects Roger Cortesi* Director, Criteria Development and Special Studies Division David Flemer* Director, Ecological Effects Division George Armstrong*+ Director, Health Effects Division Alphonse Forziati+ Director, Stratospheric Modification Research Staff William A. Cawley* Director, Technical Support Division Office of Monitoring and Technical Support Michael Mastracci* Director, Regional Service Staff Office of Monitoring and Technical Support Gerald J. Rausa+ Program Officer, Energy Related Health Effects Office 9f Energy, Minerals and Industry William A. Rosenkranz* Director, Waste Management Division Office of Air, Land and Water Use Wilson Talley* Former Assistant Administrator for Research and Development Mel Myers+ Technical Assistant to AA for Research and Development Richard E. Marland+ Special Assistant to AA for Research and Development A-17 PAGENO="0334" 328 Office of Research and Development (Cont.) George Simon+ Supervisory Health Scientist Administrator Bernie McMahon+ Chief, Administrative Management Staff Robert Edgar+ Chief, Planning Staff Robert Lee+ Management Analyst Denise Zwink+ Health Scientist Jeanie Loving+ Health Scientist Robert E. McGaughy+ Senior Toxicologist, Cancer Assessment Group Health Effects Research Laboratory, Cincinnati, Ohio Dr. R. John Garner*+ Director Dr. James B. Lucas* Deputy Director Dr. Elmer V. Akin* Chief, Viral Disease Group Dr. Peter J. Bercz* Chief, Chemical and Genetic Effects Group Dr. David A. Brashear* Microbiologist Dr. Richard J. Bull*+ Chief, Toxicological Assessment Branch Mr. J,K. Burkard* Chief, Mechanical Group Dr. Kirby I. Campbell* Acting Chief, Functional Pathology Branch Dr. Kenneth P. Cantor* Epidemiologist A~-18 PAGENO="0335" 329 HERL, Cincinnati (Continued) Dr. Norman A. Clark* Director, Laboratory Studies Division Mr. Emile W. Coleman* Research Chemist Mr. Gunther F. Craun* Chief, Epidemiology Branch Dr. B.F. Daniel* Genetic Toxicologist Mr. R.M. Danner* Acting Chief, Biochemistry Group Mr. T.H. Erickson* Microbiologist Mr. D.G. Greathouse*+ Chief, Chronic Diseases and Biostatistics Group Dr. W.E. Grube*+ Acting Director, `Program Operations Staff Mr. A.E. Hammonds* Computer Specialist Mr. W. Paul Heffernan* Chief, Developmental Toxicology GroUp Mr. R.G. Hinnsers* Chief, Exposure Systems Branch Mr. Walter Jakuborwski* Chief, Bacterial and Parasitic Disease Group Dr. F.C. Kopfler* Chief, Exposure Evaluation Branch Dr. Norman Kowal* Research Medical Officer Mr. D.A. Laurie* Physiol ogist Dr. R.D. Lingg* Research Chemist Mr. Edwin Lippy* Chief, Outbreak Investigation Group A-19 PAGENO="0336" 330 HERL,CINCINNATI (Continued) Mr. Myron Malanchuck* Chief, Experimental Aerometry Group Mr. Leland J. McCabe* Director, Field Studies Division Dr. R.G. Milton* Chief., Organics Identification Group Dr. Robert Miday* Medical Officer Mr. G.E. Michael* Environmental Health Scientist Mr. R.G. Mlller* Chief, Tissue Analysis Group Mr. James Millette* Chief, Particulate Analysis Group Dr. John G. Orthoefer*+ Chief, Pathology Group Mr. Herbert L. Pahren* Physical Science Advisor Dr. W.E. Pepelko* Chief, Physiology Group Dr. Michael Pereira* Research Pharmacologist Mr. Merrel Robinson* Biologist Dr. Frank W. Schaefer* Microbiologist Ms. Cynthia Sonich* Environmental Health Scientist Dr. Robet't W. Tuthill* Epidemiol ogist Ms. Nancy S. Ulmer* Research Chemist Dr. Jean M. Wiester* Research Physiologist A. 20 PAGENO="0337" 331 HERL, Cincinnati(Cont.) Mr. F.P. Williams* Microbiologist Health Effects Research Laboratory, Marine Field Station West_Kingston, Rhode Island Dr. Victor J. Cabelli*+ Director, Field Station Dr. Morris Levine* Research Microbiologist Dr. Alfred Dufour* Research Microbiologist Dr. Paul Cohen* Chairman, Microbiology Dept., University of Rhode Island Health Effects Research Laboratory, Research Triangle Park, NC Dr. F. Gordon Hueter*+ D I rector Dr. Robert E. Lee* Deputy Director Dr. R .J.M. Horton* Senior Research Advisor Mr. Orin W. Stopinski* Physical Scientist Mr. James R. Smith* Physical Scientist Dr. Donald K. Hinkle* Vet en nan an Dr. Thomas M. Wagner*+ Acting Director, Program Operations Office Ms. Ann H. Akland* Supervisory Program Analyst Ms. Margaret C. Mickelson* Administrative Officer Dr. William C. Nelson* Acting Chief, Statistics and Data Management Office A- 21 `~3-778 0 - 79 - 22 PAGENO="0338" 332 HERL,RTP (Cont.) Dr. Victor Hasselblad* Supervisory Mathematical Statistican Dr. John P. Creason* Supervisory Mathematical Statistician Dr. Daniel F. Cahill* Director, Experimental Biology Division Dr. Neil Chernoff* Research Biologist Dr. Lawrence Reiter* Research Pharmacologist Dr. John W. Laskey* Supervisory Research Biologist Dr. Joe Elder* Chief, Neurobiology Branch Dr. Carl C. Hayes* Chief, Air Pollutants Branch Dr. D.C. Gillette* Economist Dr. Willson B. Riggan* Research Health Scientist (Statistics) Dr. Dorothy Calafiore* Epidemiologist Dr. Robert S. Chapman* Medical Officer (Research) Dr. G.S. Wilkinson* Epidemiologist Dr. Gregg Prang* Epidemiologi St Dr. Michael D. Waters* Chief, Biochemistry Branch Dr. Joellen L. Huisingh* Supervisory Research Chemist Mr. Larry Claxton* Biologist A..22 PAGENO="0339" 333 HERL,RTP (Cont) Ms. Martha Brown* Biologist Dr. Stephen Nesnow* Supervisory Research Chemist Dr. William F. Durham* Director, Environmental Toxicology Division Dr. Ronald L. Baron* Physical Science Administrator Mr. August Curley* Chief, Toxic Effects Branch Dr. T.M. Scotti* Medical Officer, Pathology Dr. C.Y. Kawanishi* Research Microbiologist Dr. Jeffrey Charles* Research Pharmacologist/Toxicologist Dr. Joseph Roycroft* Pharmacol ogist Dr. John H. Knelson* Director, Clinical Studies Division Dr. Ralph W. Stacy* Research Health Scientist Dr. Donald E. Gardner* Chief, Biomedical Research Branch Dr. John O'Neil* Research Physiologist Mr. Jerome M. Kirtz* Engi neer Dr. Edward Hu* Microbiologist Dr. Mary Jane K. Selgrade* Microbiol ogist A-.23 PAGENO="0340" 334 HERL,RTP (Cont.) Dr. George M. Goldstein* Chief, Clinical Pathology Branch Dr. Mirzda Peterson* Research Microbiologist Dr. E.D. Haak, Jr.* Chief, Physiology Branch Mr. Matthew Petrovick* Research Biomedical Engineer Dr. Vernon A. Benignus* Research Psychologist Dr. David A. Otto* Research Psychologist Dr. Brock 1. Ketcham* Medical Officer Dr. Milan Hazucha* Medical Officer Mr. Walter L. Crider* Chief, Research Services Branch Health Effects Research Laboratory, Field Station Wenatchee, Washington Mr. Homer R. Wolf*+ Director and Research Entomologist Dr. James E. Davis* Deputy Chief and Biochemist Dr. Donald C. Staiff* Research Chemist Dr. Larry Butler* Research Chemist Environmental Research Laboratory, Narragansett, R.I. Dr. Eric D. Schneider*+ Di rector Dr. Richard W. Latimer* Director, Laboratory and Program Operations Division A- 24 PAGENO="0341" .335 ERL, Narragansett (Cont) Dr. J. Prager* Ecologist P. Yevich* Research Biologist and Pathologist Dr. P. Rogerson* Chief, Analytical Chemistry Branch Dr. G. Hoffman* Research Chemist Dr. G. Zaroogian* Research Chemist Dr. G. Gardner* Aquatic Biologist Dr. A.R. Malcolm*+ Research Chemist Dr. E. Jackim* Research Chemist Dr. G. Persch* Aquatic Biologist Environmental Research Laboratory, Duluth, Minn. Dr. J. David Yount*+ Deputy Director Dr. William A. Brungs* Director, Office of Technical Assistance Dr. Kenneth E. Biesinger* Director, Office of Extramural and Interagency Programs Ms. Evelyn P. Hunt*+ Chief, Research Support Section Dr. Gary E. Glass* Research Chemist Dr. James M. McKim* Chief, Physiological Effects of Poillutants Section Mr. James H. Tucker* Aquatic Biologist A- 25 PAGENO="0342" 336 ERL, Duluth (Cont.) Dr. Gilman D. Verth* Research Chemist Dr. William A. Spoor* Aquatic Biologist Mr. Charles E. Stephan* Environmental Scientist Dr. Bernard R. Jones* Director, Duluth Research Branch Mr. Armond E. Lemke* Ecologist Dr. Glenn M. Christiansen* Research Chemist Mr. Frank H. Pulglisi* Chemist Mr. Douglas W. Kuehl* Research Chemist Mr. Richard E. Siefert* Chief, Physical Pollutants and Methods Section Dr. Philip M. Cook+ Research Chemist Dr. Richard L. Anderson* Research Entomologist Mr. Anthony R. Carlson* Aquatic Biologist Mr. John H. McCormick* Aquatic Biologist Mr. John I. Teasley* Research Chemist Mr. John G. Eaton* Chief, Chemical Pollutants Section Mr. Robert W. Andrew* Research Chemist Mr. Leonard H. Mueller* Research Chemist A-26 PAGENO="0343" 337 ERL, Duluth (Cant.) Mr. Robert A. Drummond* Aquatic Biologist Dr. John E. Poldoski* Research Chemist Environmental Research Lab~ratory~ Gulf Breeze,, Fla. Dr. T.W. Duke*+ Di rector Dr. T.T. Davis*+ Deputy Director Dr. N.L. Richards* Associate Director for Extramural Activities Dr. J.A. Couch* Coordinator, Experimental Biology Team Dr. W.P. Schoor* Aquatic Biologist Dr. J.I. Lowe* Chief, Experimental Environments Branch Dr. D.R. Nimmo* Research Ecologist Dr. G.E. Walsh* Research Ecologist Mr. D.J. Hansen* Aquatic Biologist Mr. S.C. Shimmel* Aquatic Biologist Dr. N.R. Cooley* Research Microbiologist Dr. Richard Garner* Research Chemist Environmental Monitoring and Support Laboratory, Las Vegas Dr. G.B. Morgan* Director Dr. R.E. Stanley* Deputy Director A-27 PAGENO="0344" 338 EMSL, Las Vegas (Cont.) Mr. W.E. Petrie+ Director, Office of Program Management and Support Dr. J.A. Santolucito*+ Director, Monitoring Systems Research and Development Division Dr. Pong Lern*, Researach Chemist Dr. J.V. Behar* Director, Monitoring Systems Design and Analysis Staff Dr. Robert Papcher* Medical Officer Dr. E. Meier* Methods Development and Analytical Support Mr. A. Jarvis* Chief, Quality Assurance Branch Dr. G. Wiersma* Chief, Pollutant Pathway Branch E~r. G. Potter* Chief, Exposure/Dose Assessment Branch Dr. D. Smith* Chief, Farm and Animal Investigation Branch A- 28 PAGENO="0345" 389 APPENDIX E THURSDAY, NOVEMBER 30, 1978 PART ii 2 -~ UNITED STATES ENViRONMENTAL PROTECTION AGENCY *~EPA REGULATORY AGENDA A-29 PAGENO="0346" z t I S e o C i ~ oat 3 ~ >~ ~ ~ a - 2> 2 3 1~ a z I a C 0 r t o~ S S 2 0 n 0 S H ~ RE U C S PAGENO="0347" I -. 3 1. I.( z 0 z cc 0 xl 0 cc cc p3 I `-7' CD PAGENO="0348" 342 56160 NOTICES MAJOR EPA REGULATIONS UNDER CONSIDERATION-Continued Name and droeription of regulation Propount date in Foneeoi. Rsosscso Find date In Fsnoosa Rr.usoggs Contuct person andaddreis Too Conan Ass Ace 40 CFR 00 NSI5S-.Ssrfsee Casting Operations/se Fvbru~ry 1079 do Do. data dun-cable Plotdo, CAA ill. Evoparatise rmiouissss frsno rnodag oleralinco lv the auto OCP 6 4 0 hsnotM 10 d Do atuns/ollutncg. CAA ill. S.lsvtioo of a drgrvr of control of mission from manufacture nl 550 mcior uraoosvehsmlealo Is to be made. A series of nlocdardn out he proposed. 40 CFOS 00 NODS-Can CoalIng. CAA Ill. Thu Noes-sober 1070 September 1900 Do. regulation will enlohloh emission otaodardo tar 00 NSFS-Preeasre Ss-s,sillve l'opes and January 1900 November 1900 Do. Labels Cooling. CASt ill. Thin rrnulstlon will eu aobiloh emission standards for nolotlir organic esatuoioau feom prrueure avnsltlir tapes and label 411 CPR 00 NSPS-.iilrlai Fsrnltare Surfove Coal December 1070 December 1979 Do. Isp CAA lii. Ililo vguiatinn will eotabllsh emit. sIan standards for volatile orgunic emissions from metal furniture operations. 40 CFR 60 NSPS-Lesd Pattern Maotfaelarsop. April 1079 February 1959 Do. CAR 111. Thin regulation will eotabliah emission standards for lead sod soifurle acid mlot emis. slons from lend battery musufacturino faculties. Ths setion on H2S04 sill key the renslrcmnct thai Slat es regulate misting sources andre see. 40 CPROO NSPS-Gas Turbines. CAR 111. This Ocl. 3. 1977 February 1979 Do. reguisilon sill establish Ilmitatinno an oxide of nitrogen emisslono framutationary ass iorbisea. 40 CFR 60 tsSPS-Itdassrial Rollers. CAR ill. October 1500 August 5991 Do. This regulation will control the rsnlsuiona of par tlealalru. NOs and 001. 40 CFR 60 NSPS-Phosphaig Rack. CAR 111. Tlou May 1979 March 1900 Do. regulation will eenieol she emituiao at psrtleu. 4OCFR 60 sllusniasm Plasi Flouelde Control- January 1979 NOvember 1979 ...... Do. Erist tog Plsttls. CAA llildl. These are guide. liars for Sense roniral 01 liouride rmloniocs from 40 CPll 60 Guidelines foe g.eieiiop Kraft Ps,ip Feb. 23. 1970 January 1970 Do. Mills. CAA lltldi. Three are guidelines to ran teal sulfur lodorus frem enlstistr Stroll pulp miiiu will allow Stuies fienibiluty in etiabllsiiiisg eon. 4OCyR 60 Liol of New Source Ps~rfortsistsee Aug. 31. 1979 May 1979 Do. Standards. CRA 111111. The 1077 Clean Air Art requIres the Adminitleatar to lint the categories of malor stationary saueees Iliac are not alrruda' eantrelted by NSPS. He moot Shea Issue nlatsd. arde foe there estrgaries within 4 seats. We are deeetcplng emission ulucniurdn tsr iiaeardnio air poilotants andre use. ll2uf the CAA. Tltio seetian requires that also Admlnlatrator deeelcp National Satiation Standards tar Hazaedauo Air Pollutants INESHAPOI far emissions which cause oreastribsite to air satiation which results in an lnfreaseia mortality, or an increase in aerioto nr neapaylauciag liiusus. The standards would appiy to both newuoureea and exiotiaguourees. 40 CFR 61 NESH.OP.5. slshestoo.Irost Ore Beat ~t Ssplrmher 1019 July 1080 Don Onodwin 1MD.13). eislioo. CAA 113. Tltlu rygulalion scald rslub. EnvIronmental Protection Agency, lob limits as aubeotan etttiaulcns tram iran err Research TrIangle Park. S.C. benrfieiatinn turitlairn. 01711. 919-041-0271. FTS 0429- 0271. 40 CFR 01 NESJf.OPS. Vinyl Chloride Amend. June 7.1917 Indeterminate Do. mesis. CAR 112. The prapoard regulaliuns have called tsr itterruerd central of roiositsg saucers. striugrnt central af nra nuttrrec. sad seers emis 40 CFR 61 N~Sle.iPS. Handling sad .liorege. August 1979 June 1900 Do. CAR 112. This rrguiulian wesild ranted the hate dlicg and sucragr at henernt-nno br,occe.rirls liquids. 40 CFR 61 NCSII.5F5. Oaouline Distribatlon Spa ledelrrminste . Iadrtermicate Do. lenta CAR 112. Ttnis rcgulaliaa would eacleat benr.ece emissions from snaler marketing tcstrrrt sarh 00 bulk iermianis. bulk pistIls. nsA orrsire 4OCFR0I NESdf,tF'5-5.llnsc, Scstrtee. CAA 112. Srptember 1970 November 1000 Do. Tllia regulation would Conical the ennusioc of brssttoe Irota taint sources as writ so from fugi. lice sources Ipumps. salvos. rle.l and saole din. 4OCFR 97 NESIIsIPS-alatssednlspdnde, CAR 112. January 1979 Nsnember 1979 _.. Do. Titus regalatlan wotsld eociral sIte rmiuuian of benarne its sIte mnnufueturssaf maine unleadride. 40 CPR 01 NESIC.5PS-Eillul R.'oestie. CAR 112. Mureb 1979 Jaaosry 1950 Do. Titis reasdation weuld rootral tlse emiutiass of bassaeae itt sIte nsatsatat1t55P af ethyl huaaese. FEDERAL REGISTER. VOL. 43. NO. 231-SNURSDAY. NOVEMBER 30. 197$ A-32 PAGENO="0349" 343 NOTICES 56161 MAJOR EPA REGULATIONS UNDEIt CONSII)LItATION-COlttlflUCd Name sad dencrlptl000f regulation Prqposal date Ia Faucets. Rnnssenn Float dat' a F'rnnnus. Olnotoena (toutaet person and addreos TssCs.ncea Ala Ace `0 CFf1 61 NF,$IIAPS-Sloo'ne CAA 112. This June 1979 AprIl 1980 Do re-o'tlution auuid control the eivi.','iioo of henoeao tO CIII 01 NASIL4PS Asfo'alos Reltu.o'd froci Moy 1940 March 1983 Do Crwu)t,'d Sluou CAA 112. Us of eruoht'd oerpea tioe rack foe roadway auelOfiog moy rt'lca.c 010 nificolil quartitlen of sohe'tiu, A noao&torleg pta. aeon I undue way and reaulta indluate ntuod.lrdo will be prapun'd. 40 CFR 61 NESI~APS coke Ocen lehieotun' December 1978 September 1979 Do. Cka,'pieg Cpt'ralloas. CAA 112. Tioc eegolutiot would dime coke ooen ptviuti000 0.55 hnwueti'sn air pollutant. Charging opretti000 would be rca daiod beta. ftegulatloila on top tidc icuka would .10 Cr8 61 NETHAPS:Areenle. CM 112. A hcalth December 1979 Joe Padgelt (MD 121. rivk aetvoveoeot In beleg conducted. I file deipe- Esivleoamentai Peoteetioo Agency, wilted abut acuenio emlooloeta )pelooaeily from Reocaech Teianglr Park. N C copper amclteex) are a haua~dooo air pollutant, 27711 019-541-5204, Fl'S 8-O~l9- then emiuclon ntaadaedu would ho yeopoued. 5204. 40 CIeR 57 Prlmuee Noofurroas Smeller Orderl. December 1978 April 1979 Judith l.,ueoen 270-3411. CAA 119. These regulatiuna will estubiluh the Eootpunmcolul Protection Agenoy. sahutatotlve rcqltiremenl$ Of ioltlal pclmaey woo- Wauhlng000. Cs.C. 20460. 202-759- ferrous smoker ordero tPIOO'st uwd he proce- 2983. durea to be uoed in Imuieg them. 500's will allow certain copper, lead, aad slat noellero to delay compliance wltit the reqomremeotu fur con- slant coatrol of sulfur diunide etolnslonn ond let them use tall atuclss nod aopplemeulaeY control 40 CP'50 96 Nonpompilunee Penutiieu. CAA 120 do Undetermined Sob Siomiak 1EN-341). EPA Is required to eutabiish a penalty progrneo Eeovlronmt'otol Pruteetion Agency. to start collectIng mosey from pollotcra altc'c Waehington. DC. 20409, 202-701- mid-1970 In an amount eqoni to the money the 2542. puliotersanno by failing to obey the law. 40 CFR 51 Tell Sfock Reoaloiioo CAA 123. The Nooember 1978 AprIl 1979 Dick Itloado (MD-IS) regulations will apeelfy what height ttacka may Enoiroameotal ProtectIon Agency, ho' glees reedit for dispeeoioet under hlate imple- Research Triangle Park, NC. nteolution pIano. 27710, 909-041-5251 P'I'S 0-929- 5251. 40 CPIO 91240 Reptalnllooo Pmrldhop for Slole/ Mao 18, 197~ .... December 1978 John Slidlnger)AW445) !oct~1 Cueloallelluu. CAN 121. The rt'gululiuelu flnvleoatuenlal Protectiuo Agency, will aek the cealea to provide a sativioctory proc Wsohtlngtua. D.C. 20490, 202-050- cm of 000uldtotlun with local gooeicmenta, elect- 0481. Cd officlalo. mod l,'e'Jeral land monogeco. `file ecg- utatiuol will alto eeqoirc ICe Ototca to ohooue a lead ylaoalag orgauieatlon to coordinate the - Stale Iecplrmentttiou Plaareviolunu br utldants. lamogl andearbun monoxide. 1370 Llsonc of Rudloueliie Pollaluodw CAN August 1980 .... Undetaemihed - William A. MIlls IAW-4601. 121. DetermIne whether radioaetite poilotaulo Enoironotentul Protection Agehey, Ihail he cloouilird an 500, 111. or 112 poilotneto oe Washltogton, D.C. 20460, 703-007- none of theue categories. 0304 40 CFR 51 £mlsslon Offsel Pol)eo Recnloliooe. Dee. 21, 1976 .,_ November 1978 Kent Perry (MD-Ill. CAA 129. Tb roe regulations addreou the iutoe of Ilnolronmentnl ProtectIon Agency. whether aod to altat rutcltt the natiuteal ambi- Reseacah TrIangle Park. S.C. ent air qualify slandn.cdn eatablialted under CM 27711. 919041-0343. Fl'S 9'029' reotciet or prohIbIt growth of tooler new or en 9340. pnoded air pollution sources. Thyor proymed re visleos reflect the public comments iiociudlog four puhlle heorings on the December 21 rulioa and the ellanges required by CAA Atoendmeolu of 1977). 40 CFR 01 and 52 prewees)Ion of Sicnifieunl Dde- December 1879 October 1080 DIck Rhoads eMD-10l. s'Iorullots tPSDI. Set I I. CAN 100. Tltt'uc rrgoia- Stnelronmeotal Peotection Agefley. tions will insure eliot scs'au which ace ia eampli- Research TrIangle Pack. N C. aveewilh hyitroceel010, yo,'.,o otoawolde. photo' 20011. 9t9b4l42h1, Fl'S 8629 chemical onidont, and nlteogcn onide ntoadurda 5251. remain in cootpiiaoee. Vlssbllllc Ptoleelloel. CM til7in(. EPA Is re Ontuher 1979 August 1550.....-. ,,.,.,,..,.. Sue Padgean qeljred to prepareareport to Cuaaeeuu aad guide- EssolronOtclotal ProtectIon Ageley. liacu witiels requIre SIPs to addresa violbilllp Research Triangle Park, N.C~ problemu, 20711. 919.541-1204, Fl'S 842Pr 1204. 40 CP'It 89 Ot'qstirs'osenl.9 Co Build Detcooslrohioch December 1978 - July 1070 ,.... Karl lOtliman Cued Mete 11t9 ltd (trgot/Mthu' NOx Siuodaetl CAA 93nIloieo Cootral Technology Diol- 203. All manofayaueers wIlls a ltuut a 0.5 pet nloO. EnolronsneOtsl Prott'etion ahare of the U.S. peust'wieer ear mnriuet will have Aneltty, 2065 Plymouth Rd. Ann to build renesreb vehiatu's n-hlch nlet't the 0.4 Arbor, MIob. 40108. 313-649-4246. grams nitrogen dionide per mile reec'nrch obiec- tile. ThIu regulution will be publioht'd In Itlterilo' 4 clnal form. 40 CFIO 86 fluke-Daly Db'sch Puefiealale Siund do .,................................---...-..`." July 1959 ,,... Mere55 Koeth. geds. CAN 202. EPA is ryqitiet'd to tat particulate EssbeIOll Control Technology DId standards bor suoblia' soitrees alortinc In 1901. - nlnn. Fnolroetmentol ProtectIon Tile rs'golnliou wiii eeotatn 1981 alahidneilo nt,d Agrnep. 2065 Plynloltth Rd., Ann more ulrlwai'nt alnodardu for 1003 and loti'r Arbor, Mich. 48105. 313.000.4299. msdcl years. ~EDE0AL 060ISTER VOL 43, HO. 231~THURSDAY, NOVFMSER 30, 197R A~ 33 PAGENO="0350" C,' C, 0 z >9 I C 2 0 0 0 `4 0 z cz ~ 0 z 0 `4 0 z a, i g g .~ ~ 0 z g g32 ~). -~ 11 a PAGENO="0351" 345 NOTICES 56163 MAJOR EPA REGULATIONS UNDER CONSIDCRATION-Contlntccd Namr and dcsncrtpooe of rc'gotailon PeopOoal date to FOneotM. Rr.acoien FInal date in FanenAL 106058088 Contact poroon and address TonCanues Ass Aco 4OCFRO6 35'iet'iae Lit/vet oulAtdiltny v/Nc. Ilcttdiog FrankStauc'irrlkN.338t. Iticcoetet CAd 211Db). TIte eegtclnilon will itch 9icv.trooneintal Pruirttutci Agency. Slab a prorvsnt for tcotlng mofsrc.ji'ten 01 it. cv' Wiehtogton, D.C. 20400. iv2.751- serebty tine to assure euccpfianee cdt emlv.:ivn 0508. ntaadurcls 40 COlit 06 ,Oelvctive Eufacectnent Aoditvuo cv! Decrmbor 1078 FJbeaory 1579 Do. Ikoci Dat's 5~ec~ises cccl Vrhlcles. C~A 2Othb). lice roctctattun wilt eotabtthb a ettcvgratn for Ott log hiary dtty ecgittrn and tcitirtcn at the no. senibty tine to assure complIance with contusion sts.xtitvrds. 40 COSt Ito Engine Poroocsfer Adjustment Erywts. Oct. 21, 1977 November 1978 Ron Itrone. lions. CAd 2011(b). This regulation mitt ttcntt'ihe Envtrnnmentat ProtectIon Atieni'y. adjeotmeot pacumvtern of emlnu~ona.ceiated coo' Ann Arbor. Mteh. 48105, 313608' troinon Vehicles to ensure that altec the vehicles 4317. p055 certittctilvn tests, they are not readjusted in tlefit:v ty detlorutilpo or service statIons to loipieve their drtveabtiity nt the coat of In. 4OCb'ItOG 1144 Hlghdfii 4 S did CAd My1981 14 ions Erect N Obe AW400t bOlt). Theno ergulattons wIll require all vehicles Envteonmefltal Pt'Oteetton Aoenry. to meet standards at alt altttodeu begInning wIth Waohlngton, D.C. 20460. 105.719' 1984 models. 0996. 40 CFR 80 Peacllles far Nsneompleing Heoi'p. December 1978 February 1979 , Prank SttvetertEN-338t. Dale Engines 040 VehIcles. CAd 100151. ThIS reg' . EnVtrOniOe8tal Protection Agency. 0181108 p0014 allow heavy.duty eogine or vehiCle WashIngton. D.C. 20460. 202.7$- manufacturers to sell vehicles or engInes enceed' 1972. ing the standardo If they pay a noncompliance penalty. They stiff would not be cold, however. It they euteod an upporilinit. 40 CON $6 Emission COntrol Wurroelfiv CAd December1978 June 1979 .... Rick FrtedmantEs'340t. lo7taitlt. The regulations acttvate a maoufactue' Lersironmental Protection Agency. ses warranty that becomol eutorceabte If the em Washington. D.C. 20460, 202.424- hIde exceeds enilsltonstaadords as a recoil of 4090: defecttn yresent at the time odssle. 40 COlt 88 4/ternisrkel Peels Cerli/Iueuilon. CAA January1970 August 1979 David FeldmantF.N.340t. bultstt2t. The regulatIon establishes g.cldoiineo Environsnentai Protection Agency. so nttcrmarket parts monu(nctcserru can entIty Washington. D.C. 10460. 202-755- that theIr parts do not degeadn emiy.sions. 0297. 40 CON 80 SOon Deaf for £vitssion tvoeeunliea May 28. 1977 uary 1979 DIck Nash. CAA SO7tbt. The regulation rctobtiuhen proce Envirooeionisi Protdction Agency, Jones for tents of snctsu:vcus from light duty Ansi Arbor, MIni. 48t09. 313.660- truvhu anO light doty vet>icteu to he yorlorcccd iso 4413. n'oecjsocctios wIth inofuiciioo/mtintenaiive pro. 00 CORnS Emission C'nntrol lpv'eforrcuncct War' November 1070 April 1079 _. DavidFrldmauikN340t. fade. CAA 207ub1l21. Tt:in rcgutxtlon eyceiflos 000irOeinentol Protection Agency. cectormnnee warranty rtqulrentents baled 00 Wuuliington. D.C. 29460. 503-755- shortryctes emtsoione teat foe In.tiur vehicles. It 9207. was pcoposed In May 1917 and Is now brIng re praposedtu toke the Clan Air Act Amendsnenis 40 CFR TOG DorIs oud Fart .iddificrs Protocols January 1919 May 1919 Malt nillutfto-euOt. for Teslic~ CAA 211. The prolocols will help do. Eeclronmertai Protection Agency. termtnc ntfrnlo of fuels and furl ndditlvcs tic Wauhlnotun. D.C. 20460, 1o2'420' public health and emloelen rvctroldeu'lnes. 4452. 40 CON 86 Hip?, Atlifude Penfoensovr Adjasi' February 19(9 February 1980 Ernie Rooenbeeg IAW.4uu). carols. CAd 210. EPA is required to set piece. . Environment at Protection Agency. mrnfs to thrtr naru for 1*1gb aititade operation . 0506. 40 CP'R86 Turbine Mecca/I Ous.'oos Emissions blur. 24. 1970 September 1979 , Wiitlam Houtman~. Reirofit and Modi/*caiien 0/ j9?3 Slosdqrds, Environmenlat Protrn(Iun AgeceF. CAA 231. `I'huo rrs.olntinn wIll propose, anti for Ann Arbor. MIrh. 48105. 313-600" come classes of aIrcrsft. repropose emiaoiuft 4272. ntsodards for large aircraft to reduce HC. NOn. wIld CO. `50 CON 10 Jleioonsi 1.'onaisl,.vn. CAd 301. EPA January 1970 Undrlrrmined DareslTylrrtMD-t3i. is enquleed to provide (or enocioten) Icplemetcta EnvIronmentAl Pevtertion Agency. elon of lhc Cleon Air Act by the narioua EPA Re Rcscarrh Triuneis Park. NC. gloonlOetteen. 21711. 919-1415241. P18 8029' 5425. 40 f'FR 51, 13. 52. 59, 00460 Otonllveluq 8e'juts' dog. 7, 1908 January 1979 Robert Nt'(lgnultdD 14). tints. CAd 319. Thrnr rgiduttnnn will revue (he Envlrccmrnlul Protection detect. C4t1.r.'ttten(o (or State sod tnt niP coliuiion Otesi'l*rnn Tvivwgio Pork. S.C. (or p(iepssv't of Ss.iti' inupl,'v'evi:.tioe 27711. 919-5415447. Fl'S 8620' piano ood forrviiorling uirqcvtity Isis to lIPA. 0447. Tics Moton Vgtssns.gleronuutiots onnCoerSnwsncn Art 1MVICSAI 40 COSt 55 Trc)inq Seem/If Dc'l'ia'ro/on Fact Li-eu. Acg. 10. 1077 December 1878 Ernie Rosenberg AW-458). winy Prvlcm*on,'o MVICSA 511. Tf1e ri'oniuuon Environmonfnl ProtrctioO A~n'nry. (irvvidc-s for tPd noatootlsa 01 claims by amoco. Wanbingtofl. D.C. 30400. b02~70n- f:lu'lncu.r thot it too pruoiuredafnc'lrncinomb' eat' 0504. ro(It do-vine. P0010*1 80010701, vol.. 43, NO. 231-THURSDAY. I4OVIM881 30, 1979 A-35 PAGENO="0352" 346 56I~4 NOTICES MAJOR EPAREOULATIONS UNDER CONSIDERATION-Continued Namt and descrIptIon of regolation Proposal date In Feonnot. Retraces Final date In Feoneut. Reosanea Contort person sad address Toa Ct.too Woten Aee (Federal Woter Pollution Control Act an ameoded by the Clean Wafer Act Atoendntenl.s Of 1877) 40 CF5t SteP) Stole Monayctneot Aselatsncc. Apr. 25. 1970, interIor flail. Sept. 27, 1978 Joe Eaatey (W96.947l. CWA lOUb)/205. States stay ton up to 2 percent Enelroasnretal ProtectIon Agrney. of their title II ailotrernt or $400000 whlchecer Washington, D.C. 20400. 252.426- Is greater, to finance the 000rinlatratloa of Sec. 4445. 20$, 203. 200. 212. 402, aod 404 prograton. 7 CFR 634 s0getcttlarst Cost Shut-esp. CWA June22, 1078 Tohedetersnlned Joe KrIt'alaIWU.555) 20t(JI.l. The Departsos,nt of Agrieultorn will pro. EnvIronmental Prolrrtloo' Agency, tide gstntsnocerlag ap to 59 portent of cooto to Washington. D.C. 20440. 252.755- Install bent management practices for water qual. 7000. Ity ma000egeent. The program 0011 be iotple.hy the USDA. The regulations wIll he promoigated by USDA wIth EPAenncorreaes. 40 CFR 35 Waler Qosllsp Mona5eetent Recals. Sept. 12. 1978 Janoary 1979 Linda ElchmtllcriWlg-554). lions. CWA 106. 208. 3031el. Them regolatlono Environmental Pratectloo Agency, reuse and update the water qoolity management Washington. D.C. 25460, 252-7~5- regulationn precIously Issued under 40 CF1O 130 0985. and 131. 40 CFR 35.90 State 208 Regulatory Proprsots fee Januory 1979 July 1979 Jon Keleab. Dredge and Fill Matertrsls. CWA 2051b14l. Those Enelronmental ProtectIon Agenry, regulations will authorize Staten to establish mg Washington. D.C. 20460. 202.705- statory programs fnrthe dinchhrge of dredge and 7000. till material to aopplemssst State 404 permit pro grams. 40 CFR 233 MsdI/teigtloo sf Secuesdsrp Trcuteaent. Ape. St. to~n Docember $978 Tam O'Farrell cwss.nsti. Re006remenfs Jbr dfsetese Dlechuryers. CWA Ennlroomental ProtectIon Agency, 3OIlbI. The $077 amendments of the Cleuo water Washlagtos. D.C. 20460. 202-420. Act allow EPA to modify the treatmeot require. 8976. mOnts for eototlag ocean diucluorgecs from Pub. Ilety On-a Treatment Works (POTW'ti is regard to the reqslrod degree of rentocal of Slologicol Osygen Demand (SOD). Total Suupeoded Solids (T5SI. and pH. Appllcuats are required to meet night spenlfie 301hs criteria In additiso to ant' other applicable crIteria of the Act. The receipt of modifIcatIon moUld not rellet'r a POTW from complIance with performance ntuadaedu o'hich EPA will later publIsh to reflret Best Peactlrable Wastewater Treatment Technology iEPW'lTi. ThIn role eatabllnhes the celterin which EPA mill apply and theprocedurenlt Will follow hilt coal. uatloaof application fore modlfivatios. 40 CF'S 124 £xlessscn of Pollatlots Conical Deud. bloc 16. 1978, loterim ftsal WIll helneorporated lots NPDES Ed lCramerlEyt-3361. lInes for Publicly Owned Tresfmeol Works and pmngeam regulations 4OCPft 122 EnvIronmental Proteetlsa Ageacy. 010cr PoInt Sources Plsnnlsp to Diochstge to to 129, Wsuhlngaon, D.C. 20460, 202.795. Those Pabllclp Own Treatment Works. CWA 0750, 30113). ThIs regulatIon mtabllahes criteria which EPA and NPDES States WIll use In rea'lewiog re quests for 35111) eoteaslooo from the July 1, 1977, treatment reqalretarotu. 45 CPR 120 Reqaltemenfsfor Appllcollon for 301 5ept, 13, t979.loterltu final January 1979, will he Incorporated ScottSleaiogerlEN-336l. (p1 and 191 Vso'isopcs. CWA 301(iglllnl. Theue IntostPDEsprogram Ena-lynasoental Protection Agency, r'rgslatluos requIre dlnehuraeo dcsiyiot 301 el regulations 40 CFR 12210125. WashIngton, D.C. 20460. 202-759- nOd IgI aurlanres to fIle Initiol applications by 0755. Sept. 25, 1915. or 275 dayn after prctnulgntiso of SAT Ilmitatluon wlslobener Is later. Etflurut guidelInes eepreuroting bent available treatment technology, new nosree performance standards, and pretreatmeot ntasdardn am beIng docelaped for tIre following Induotrlrn to yomply wilh tlse Act aud a court order mandatlug euntrol of certain tuuic substances In Industrial effluents. CWA 301, 304 306. sad 307. 40 CF'S 420 Iron ond.ftret Sfsnnfsclorltg November 5950 May1980 Ernst HalllWH-95to. Ennlrsnsaental Prstsctlon Agency. Washington. D.C. 20460, 202.426. 2576, 46 CF'S 435 Pstsnleaeskeftnong March 1979 October 1979 Robert DellloaerW9I-SS2I. EnvIronmental ProtectIon Agency. Washlngion, D.C. 20405. 252-426- 2097. 40 CFR 429 TlmberPsodacfs Pcocesssng May 1979 December 1979 Jobs RIley(W50-552I, Ennlroomental Potectlon Agency. -WashIngton, D.C. 20405. 202-426- 9994. 40 CI'S 423 `Steam Fleceroc PswerPlssts do.~ do John Lam lWlI.552. EnvIronmental Protection Agency. Washington, D.C. 20409 202.426- 4617 46 CPR 425 Lesffier Tsnnfngsnd finIshing Janoary 1970 August 1979 WIllIum SonaettiW9f.993). EnvIronmental Protcetion Agency. WashIngton, D.C. 20469 202-426- 2440. 40 CFR 421 Natsfserots Metals Ufsna)'scloe,ng Aogsst 1979 March inns PatricIa WillIamslWH.5535. Envlrounsoatal Prstmtlun Agency. Wnolilogton. D.C. 25460203-429- 2588. FEDERAL REGISTER, VOL. 43. NO. 231-THURSDAY, NOVEMBER 30, 1979 A-36 PAGENO="0353" 347 NOTICES 56165 MAJOR EPA REGULATIONS UNDER CONSIDERATION-COntinUed tlsmeumddnucrlptlooof regulation Proposal date inPunnnas.ltausmU9 Final datein FilbUaa&R8uioTUA Contact PerOnn and addreua TouCtoan WaTSU Ac? 4oCFlt 46 Poisi and Ink Poenulalion. September 1070 April 1080 Richard Oieoer)WH-502). Environmental Protection Agen~y. Woohinaton. D.C. 30480. 202.426- 3003. 40 CFR 448 P,4*Ungond Pobiiskin0deceicea November 1970 June 1080 DO. 40 CO'S 000 O,ekadogond Dressing do Joly 1980 OnOCoadtW9i 586). Environments) Protection Agene. WOOhiniltOil. D.C. 20480. 303.45 5903. 40(Th'R 434 ConS Mining December 1979 JO)). WH.886) Environmental Protection Agency. Washington. D.C. 30400. 202.426- 2126. 40CFR414 Organic Cesernicu1eMono~oclusing January 980 Augout 1980 Paul Farenthold(WH-092). Environmental Protection Agv'ery. Washington. D.C. 20460. 201-425. 2407. 40CO'R 415 InorganiC Chemicals Msnofeclartog.. September 1079 April 1980 Waiter IIuntlWll-592i. Environmental Protrelien Agency. Wouhlngton, D.C. 20460. 202420- 2724. 4OCFlt 410 7hx646rMWs May 1979 December 1979 JameuOalluptWH-992l. Envlronmeotal Protection Agency.. Waohinnton. D.C. 30460. 202430- 2594 4OCP'5416 Plaslimanddpathe)lc Moieedoi January1990 Aoguut 1980 .. Paul Fahrnntheld iWSl-052i. Environmental Protection Agency. Washington. D.C. 20460. 202-426- 2497. 40CFR439 Pidpand Paper February 1900 do Sob DelllngvriWlt-992l. Environmental Protection Ageocy, Wanhlngton. D.C. 20460. 201-436- 2904. 40 CO'S 420 RabberProcesoing June1970 January 1980 Do. 49CFR 417 despond Detergents Muno/oyinring.. July 1900 ..., July 1981 ... OlnuntY Hg 1WH-0801. Environmental Protection Agency. Wnuhiegton. D.C. 20460. 202-426- 3903. 4OCPR 444 Anloond OlherLoondriee December 1979 JoIy 1000 SlehardOlggeriWH.0831. Environmental Protection Agency. Washinatoo. D.C. 20460. 202.426- 2583 40 CPS 494 Mlaceilaneens Chemicejs-4dhesieei February 1010....... August 1980 Elmood PornhttWH-552l. onddsatania. Envlronmentnl Prolection Agency. Wuhinuton. D.C. 20400. 202.420- 2701. 40 CO'S 497 Ulscellsnmus Cbeeslrols-Sxplosives December 1079 ... July 1980 Elnond Marlio (WH-812i. Jtuaafactarinp. Environmental Proteetiun Ageacy. Wauhington. D.C. 20460.202-426- 2440. 40 CFR 494 lliacrllaneoas Chemieuls-Oan and August 1070 March 1900 Richard WilliamniWH.992l. Woof . Environmental Protection Agency. Waahinotoo. D.C. 20460. 202-026- 1889. 40CO'S4U Mieeeltuncaaa Clteeulcsls-Pcslicides.. March 1000 October 1000 George Jett (Wsl.552i. Environmental Protection Acrncy, Washington. D.C. 20460. 202.4*8.. 2497. 40 CFS 439 slisceeeanecaa Ctenuieals-Phuecse~ Deeambcr 1079 July 1900 Joe Vitalio iWSl-052e eeasicuta. Enviroomrntal Protection Agen~.y. Woalni000on. D.C. 20460. 202-426- 2497. 4OCPR4I3 Xleclroplaiing Mactb t900....~ October1980 - MauriceOwefls tWll-9861. Environmental Protection Aien~y. Washlegton. D.C. 20460. 202.725. 1331. 40 CO'S 499 Muchlnere and Mechaoicac Prod' February 1090 S...... Augont 1980 Ernst Hall IWH-592l. aelu-Photegeopflle Eqalpmeol aud.Iopylies.. Environmental Proieclion dudley. Washbuatoo. D.C. 20460, 202.420- 2576. 40 CFR 433 Muebincre and Mechanical Prod- August 1990 March 1091 DO. nela-Mu'eSuenicalProdaele. 40 CO'S 469 Machinery und Mechoclcs) Prod- March1900 October 1000 Do. urle-0h'ctrlcul and £leclronie Cee,geeenla. 40 CO'S 464 M.v'hinerv sod Mceltonicol Prod. October 1979 May 1080 - Do. mcs-Peondre Ogu',uiiens 40 CO'S 460 Marhleeer and Meehenical ~ey50. April t000 Nocrmber 1900 - Do. uele.-Copp.'eocd Cepsu'r.llheW Prcdae)s. 40 CO'S 408 Olscislneen and Mechanical Prod- Marelu 1000 October 1080 DO. ucle-dotleep Nanufor)aring. 49 CFS 409 Moehineer und Mechanical 15ued. Aoguat 1970 Maceli 1980 00... nris-ChuulCeuliug. 40 CO'S 463 Moebinere and Mechanical Prod- October 1900 May 1901 - DO. urls-Plssvica Processing. 40 CO'S 460 dfau-ltinrrp and MechanIcal Prod- October 1919 May 1090 Ernst IlnIliWIl 992). ocla-Posvrleln Enamel. llnvironmciitnl Protection A.v'm-y. Waahinuttosi, D.C. 20480, 202 426- 2976. 40 CO'S 407 Moehineeg and Mechanical Prod- Mulch 8990 Ouloluer 1000 Do. aule-Alu,moumrecnntng. FEDERAL 1601508.9, VOL 43. NO. 231-TI4U1SDAY. NOVE 90801 30. 970 A-37 L~3-778 0 - 79 - 23 PAGENO="0354" r x C * z 0 0 0 zO 0 0I 0) a g I ! ~ ~ r q ii r I IN ~j~1 I q~ 1r~ a8 s~' ~ g~ PEa ~ `E-. PE~ ~ ~ ~, ~ g~p~ P'e3 P~ ~ P $E ~ ~ .4 a PAGENO="0355" 349 NOTICES . .56167 MAJOR EPA REGULATIONS UNDER CONSIDERATION-Continued Natoe anddeucriptlon of regulation Proposaldatein Fnnnnu. Rausocon Final date in Fgasnas.Rnusnrns Contictpernoe sndaddreeu - ToECi.nan Wu~nn Ace (Frderal Water Pollution Control Act no intended by the Clout Water Act AmendmitotOof *977) 40 CPR 231 Ocrctn DiscOurse 0eiiecis. CWA AprH 1079 December 1979 Tom O'ParrrlliWR4Sii. 403(0). Tiooe goidolinen pertain to discharges to Environmental Protection Agcfley. thn ocean. Thcy are bused on pcrtvntion oc end Wnehiniton. D.C. 20460. 2O2.424~ ronmontal driirudalloo of waters of the trrritorl 9970. ii ecu, the contiguous cone, nod the ocvann. Both Inductrial and municipal dinchargeru would 40 CFII 230 (Jucdeliccez lv Prolecl lice .4eaotic En. January 1979 July 1979.... John CrowdrrlWnt-500i. virunmenl, Including Wellondu, From the Din' Environmental Protection AgenCy. charge of Dredged or Fill Malerlut CWA Wauhinntuo. D.C. 10400. 202-472- 404(bOli. Theuc guidollnm mutt be conaidervd in 2400. the isa since of lodialdual sad genpral permits, in the preparation of Enclrunoveetul Impact State menu eElS's) for Frdrrul actloltiru upec)ivn)ly authorized by tlce Congress. and In preparation of Best Managrment Practiccu 1I1MPti under the State 200(hli4XBi program. P'allare to comply with these guldolinen justifies denlul of permit applications and return of State permit programs to the Corpn of Engineers. Sept. 1. 197$. interim.f(nal guidolloes are being reviacd and enpanded by thinelcort. 40 CFR 123 Procedarui Repalal)vns Coecrrning Oct. 21.1970 December 1970 Office of Water Enforcement. Stole Qaulipieulions for Aooumine lb. Section Environmental ProtectIon Agency. 404 Psrnttl Progrnnt. CWA 404(gi. CertaIn re Wnuhiogton. D.C. 20460, 203~450- gulremento that mutt be met fur States to 6440 assume permitting authority wider sec. 404)gi such no codification of State laws and co'rtifica. tions by theState attorney general are similar to NPDES requIrements. Therefom. the appropri' ate parts of see. 404cg) have been included in the proposed retlulon of eniuting regulations Our NPDES in p1. 123. 40 CFIL 127 Proeednrnl Regulsilono for Sxrrcie' January 1979 July t979 John Crowder. tog the 4ontei Veto. CWA 4O4ici. These regula. Environmental Protection Age~ccy. tlans will establish the proordures fur oreveotlvg WnahiSgton, D.C. 20460. 202-472- the discharge of dredged or fill material into a 3400. defIned areanf the novIces of the United Staten. 40 CFR 120 Sabsiunlice Reccluiious Concecoieg January 1979 July 1979 Do. Stole Imelrecrtsiatiou of Section 404 Percctil Pm. gtnm. CWA 404ig1, ihi. States may propose cor approval by the Admliciutrator of EPA a see. 404 progrnm in lieu of the Federal for permitting the discharge of dredge or fill material in crriain waters of the United States. These regulationo deneribed the components of a State permit pro gram that wIll be minimally aeceptahle to the AdmInistrator. 40 CFR 250 Seseuge Slndgr Dispose). CWA 405 July 1979 August 1990 Bruce Weddle)WI1-364). and RCRA 4004. These rroutnnionu are to suture Envlrnittnentul ProtectIon Ageocy, that munIcipal sludge is managed in-a manner Washington. D.C. 20440. 202751- that will protect public heallh and the environ. 9130. meat and that valuable resources are coeerrved through benefIcial uti)lr.atioe where practicable. TssnaavnDesenseu Wuesn Ace 40 CFR 141 Contml of Organic Cbecnicol Cots. Feb. 9, 1970 January 1979 JoeCutruvoiWll-090l. lamlnunts Its Dc'lnking Wuice. SDWA 1412. The Environmental Protectiosl Agettey, fient part of this regulation sets a matimom con- Washington. D.C. 20460. 202472- tuntinant levels for trlhalomethanen and the 0616. second pact establishes a required treatment teehniqueufor syntbet)curgaaleohemicals. 40 CFIt 141 Tgchnlcutdmendmeols to the Notion' December 1976 April 1979 Do. at Iuierinu-Primurii I.cnvkiog iiulir Rcgaiulsoau. SDWA 1412. Ti) etc ecgulationu will be adjust. Bests to the previausiy published NatIonal In. terim.Primnrp Drinking Watvr regulatlonu. 40 CP'R 143 National Sgeondae.i Drinking Woter. Mar. 31, 19ff February info Prank Sell iWR.114). SDWA 1412(C). Tb ear rcgu(utiono *111 be nones- Eneiroemeotal ProtectIon Agency. forceoblo guldrlineo on evilielic drinkIng water Woahinglan. D.C. 20460. 202472- pettIly. 6820. 40 CPR 144 Uod,'rgnoied Water Source Pmlcc. Aug.31. 1976 Oct. 12, 1976 Tom 941k 1WH-SlOi. lIon Program Grants. ODWA 1443(b). Thin regu- Environmental Protection Agenry. lation would act forth ecqoirentenis for under- Washington. D.C. 20460, 202'420- gfollndinjeftinn control grants. 3934. 40 C9'R 144 Unda'rgroaod Water Soarce Pcotec- January l979irepropoeal) May 1979 Do. lIon Program. SDWA 1421(61. These regulations ace intrndt-d to proirrt grooedoatrr drInking suppliru from contaminatIng cussed hP improper uodrrground inicetion of clams. The a-not major. Ity of in.ipctioo practices necars in the oil and gao Industry. Stales coo apply lee primurp enforce. ment aathnelty if tlu'p m~vt the mInImum crite' eta asn'clf led In the rogulatlanu. Tile rrgulatiuus cnuc-by.cuurdetrrncinatiosc is ncade. PBD6RAI. ggolsigg, VOL. 43e NO. 23L.4HU*SDAY. NOV6M86I 30. 1976 A-39 PAGENO="0356" 350 56168 NOT$CES MAJOR EPA REGULATIONS UNDER CONSIDERATION-ContInued Nsmeanddrnerlptlun 01 regulatIon Proposal dateln FnarjsutRensuTaa Final date In Fensaut Rsnssns Contact person and addrens Tea NuasaCoeccooL Ace 40 COlt 205 54g01 Dale Mylar Vchicleo. RCA 5. Woch plan undue deorlopment William Roper IAW.400). Thin action will result in a decision regardiun Euoirnunsnntal Protection Anroty. whether or not light dily vehiclro arc orayc not Waahistgtao, D.C. 20460, 703.557~ a major nolan source. If they are 10usd to be, 7747. then resulting noise emission and/we atm.' labcl' Ins itandards will he pecparcd. 40 CFR 205 Store. NCA 5/6. Thin regulation will Sept. 12. 1077 June 1079 .. ...... Do. net noise ensionion slsovlucds fuc new latce-Stutas. leasser.city. ned nchoolhusen. 40 CF1t 204 Teackwioiaoled Solid Wosle Contpac' Aug. 26. 1017 Juno 1079 Kvnaoth 000th lAW 4001. lou NCA 5/6. The eeguiatecnaueto noise emission Enuironmental Protection Aocncy. standards for solid waste ooncpactoru. Washington. D.C. 20400, 703-057. 2710. COB 260. 207 Lswsenoa'ero. RCA 5/6. The regula. Octoher 1979 Octaher 1080 58naeyThomaolAW~4n0l. tlan sets noise eminolon utnttdards toe new lao-n. Ens'ironmenl.al Protection Agency. mnwern. Waohinglon, D.C. 20460, 103-557- 7743. 40 CFR 204 Pseenanl DresSers owd Rock DrIlls. June 1979 June 1980 Kenneth Feith lAW-sOul. RCA 5/6. The regulation edt noise ectitsion Envtronmrntul Protection Agency, standaeds for new pasenteat hrenkern sad rock Washington, D.C. 20460, 703.557- drIlls. 2710. 40 CFR 204 Track Transported Re/rleeesliou Douelopmentol work hatted . Do. Unila. RCA 9/0. The regulation arts noise emtn- pendlog analysinof eegs~lakoey gino standaeds for new teamS transport refrigera. alteeostiu'ea, 40 CF0.204 Wheel sod Ceoa'ler Trocloee. RCA 5/ July 11, 1077 June t070 Heery'l'homas IAW-400i. I. The regulation sets a noise emisaion stnwdaed Environmental Protection Agency, fnraew wheelnod crawloe tlsetsca. Wsslalsgtoa, D.C. 20460, 7O3~057- 7743- 40 CFR 205 Motorcycles. NCA 1/6. Thin regiila. Feh. 15, mm Octuher 1070 _.... William Roper IAW-400i. hon sets noIse emission ntaodards for moloccy. Enolronmeatal Protection Agency, elessnd replacement euhauat gyuten,u. Washington. D.C. 20460, 703-557' 7747. 40 CFR 211 Lshollnp Heae-i,ag Prolecloeg. 2OCA 0. June 22, 1077 Januaey 1079 IlearyThomao 5AW-400). The regulation requires the labelng 01 keuriug Eavlrnamenial Protection Agency, proteetoes. Wsshlagton, D.C. 30460, 703-557- 7743. 40 CFR 211 Labeling: t3esaerot RCA 5. The eros. do .,.,,.._ do ......, -.........- DO. latton ewtablinhes general labeling provinicon. 40 COB 210 Adminiolrslice Hess-lug Prceedoreo. Aug. 3.1979 ._.,.,,_,,,,.. December 1070......, .....,. Jim KerrlER-35'fl. RCA 11. These peocedurro u-ill ayely to kcoeinos Environmental Protection Agency, for the lnsuawee of remedial ordees ouster oec. Washington. D.C. 20460.703.557- 11197 of the Aol. So mandated, those are aditadl- 4410, eatory hearings ander the Admlalnteatlce Pesce. dureAct. I U.S.C. 554. 40 CPR 203 Low Robe Zmtoslco Peodoelo. RCA May 27. 1077 May 1970 ,,,.... BenryThomnsiAW-400). 19. ThIs regaiation allowu a detereniaulccu of Eavironmento.l Peotectlnn Agency, when a product Is a low anise emlualon produet Wnshinglasssa, D.C. 20460. 703.507' and whether It Is suitable foe special csauldera. 7743. tIns in Federal purehasing. 40 COB 205 Iulerelole Roll Corrter& NCA 17. December 1979 February 1970.... .. ,.,.. William Roper IAW-4001. This regulatinu sets noise omioaioo standards for Estnlesnmenlal Protection Agency. raIlroad "facllllles." EPA has prepared this reps. Washington, D.C. 20465. 703-507- latinu nsa result nt osoeeeoucstl isosslt brought 7747. by the Anoociation of Asseeicao Raileoado vt-hick saId EPA's regtalatloasn netting name standards for ineomotioes tad cars failed to ad. dress the related problem of noise from faoiillit.'n such as eaileoad yards. Tlae Contra crOoned EPA to adopt final regolations eoatrolliag roilecad facilitles-eteryttaing in addition to the cars nod lncnmolives. 40 COB. 200 Special Loeol CondItions. RCA Non. 26.1976 , .,... lleneyTkomsolAW.400). l7Icl2/lOicl2. TIle eegulaaivn establluken prone. Esanlrnnmental Pententlon Agestny, dures permitting adoption by a Slale or other' Washington. D.C. 20460. 703.057' wine preempted Stole sod local rail nad ntovur 7743. saerler noise regulations when aesesuitated by special loeuleonditions.. 40 COst 202 lola's-else, os-eeoc Cor-eu RCA 10. Work plan under denelopmont ,: , - ,..,,..,,.. William RopcrlAW-490l. This action will atpdate Ike noise emioslvn stand. . Eoulronsoentsl Prnteetion Agency, arda far interstate molar carriers to reflect In' Wsslalngtnn. D.C. 20460. 703-507- creased kasw'ledge shoot avaainhle asise abate. 7747. meat technology. FEDERAL REGISTER, VOL. 43, NO. 231-THURSDAY, NOVEMEER 30, 197R A-40 PAGENO="0357" 351 NOTICES 5t169 MAJOR EPA REGULATIONS UNDER CONSIDERATION-Coatinued Nameaed deneriptlon of regulatIon Proposal date itt Fanastu. Rnxsnn'an Final datr In Fsnsnul. Raciness Contact person sod address Tue P'acnoul. Iooncesnmn. Punosvsnn. cnn RnnlOrlrsas Ace 40 CF'S 502 5PeeIi.'ide llreislrsliqu Oaidrlloee: Itsfrudueeion. FIFIIA 3. thLu subpart 0 Iwlil July 10. 1978 April 1979 Bill Preston (TS-7091. become A) Includes the groerti purpoul'u of all of Envlronsuosstal Protection Agency. the guidelines, degree of fivolbility in reqoirl'- WashIngton. D.C. 30460. 703.997. soçots and in Interim data usage, deflnhtiofl 01 7391. terms uocd lllroughoui the guidelines, and re quIrements for retention of data and toot sum pIes at laboratories. £xperImcnisi Use Prreslio, FIPRA 3. This sub. c DO. part A (will bcconee oobpart Ci upreilien the data that must be submitted in support of an appiica. tion loran experiments) ste permit, Cheesistre Rcensreeleuls. P'IFRA 3. This sub- July 10. 1078 April 1970 DO. part D covers data submission requiremeuls re sting to chemistry of pesticIde producto' active Ingredients and tlseir formulation components and msssufacturing impllrities. lCbeenicai ntudy requirements dealing nub enniroomcntai late of pes0cidea may be included here or be movrd to a nepa.. Wifdll/e snd .4000IiC Or. do May 1970 DO. eunlsess. FIFRA 3. 1105 subpart 0 outlioen the data submission requirements foe studies of pen' tielde effects on birdo, wild mammals, fish, and other aquaticanimals. flossed £cs000eion. ifumoss ssd Doctsslic Aug. 22. 1078 June 1079 DO. ,Oxlmols. FIFRA 3. This subpart F deiineatm the dala ssbmloslon requIrements for studlea nf pes- ticide effects in laboratory animals involving Oral, dermai, and inhalation uptake rootro. bode. sshchronlc, aebd chronic enposurra. and .laclsdissg local or systemic iniury and maiadim loch as oucogenic, teratogenic, mstoaenic, and nesrotonic effects. Pmdact Perjoressner. FI1~RA 3. This subpart Derember 5978 Asgsss 1079 Do, O specifIes the data submission requirements that registrants moot submit to dcmons(rafe Ihat the prospective pestIcide product will control the pests or control undesired growth or behavior as specified in lahel.claims. Label Deerlupenesf, FIFRA 3. This oubpnrt 11 March 1070 October 1079 DO. describeoull essential ports cIa pesticide troduel label. how labeling and label statemrnin must rnmpl~' witii the Act, ond bow ciaimo and direr' tiona must correspond to evidence prearnled oc on handln data on efficacy and safoty. 40 CF'S 102 Peslieidc Use Rsrsirieii000. FIFRA 3. December t079................................... January 1070 Walt WafdroplTS-770). This rrgslation will rlassify pruticldr uses for re . OssvIrossmeatal Ps'otsctloss Agency; stricted use.. Wasbissoton, D.C. 0460, 202-700- 7084,, Cosdllional Reeiserscsms Reeafulips. FIFRA _. _... February 1079 - , BobRoseITS-707I. 3(1071 (Al and (Si. This interim/fInal rrgoiation Issnironmental ProtectIon Agenny. would establish procedures for conditional rrgin. Waslsingtoo. D.C. 20400.258-420- trution 01 pestIcide producfs which ore ideolionl - 2010. or aubstantlaily similar to those csrreasly regis. terrd ornew uaes of enlsting pesticide prodocts. Cosdlllonul Regiscrscios Aegaiullon. Fii'RA July i970 - - Do. 3(cX7OC(. Tills regoiof Ion prol'idm br she condi- tional registration of new chemicals when certain 40 ~;R~~; L73 Rrpisenstioo Dslo Conipenes. Juon 21. 1077 February 1970 Old Gray IA-132I. fion. FIFRA 3iCOluDi. These ruien provide for Environmental Protectioa.Agess4y. compenuu000 when one pessicide registrant Washington, D.C. 20400, Oiis..ina- rell~u on test data genrrufed by anotlxrr `rein- .0040. 40 CPR 172 scale £epeeimenlsi Use Pcrmlls 9rpf, 30, 1071. interim final _. . Phil Orayl'1'8'770I. FlORA (5If. The reglllation drfinm the scope of EnvIronmental Protection .AmossCy. Btnte Jorlsdletion to nllow enprrlmentsl uses of Wssbingten. D.C. 2~400. 202.751- pentlrlden. . . 7014. 40 C~'R 565 Slceere sod Dluposof Pe'srilees (Pro. Dec.15. 1974 Will not be issued Joins t.ehsnan IWll400s. ?slbiiionl. FIF5OA 59. These roles will prollibif Essnirosslssental Prstecttoo Agency. dangrross or environmentally unsound pestIcIde Washington. D.C. 20400. 202-709- storage prustlers. . 9100. 40 CF'S 182 Slsfe Rrelslesllen to Mccl Spu'eIol Sep13. 1975 March 1970 P1511 Oray(TS~7'f05. Loeui Needs. FlORA 24ueI. Tltis port definca tIle EIsvIronmrntal Protection AgenCy. erupt' of Olule isriodleilon uver Ilte rroiotratioc Wssbisqitoo, D.C. 20400. 202.759. of p.'ot(eldes. 7014. 40 CFR 102.10 P,'cflt'idc Sperioc Pcckoel,,g Reqeu- Feb. 10. 1977 December 1975 MaurcenOrimmrrlTS'706I. lslioos. FIFRA 21. Tlsr rule preseribt's whs'o ond Enolronsbotstuh Protedtlun Agency, what form of elcild-prool packaging is rt'qoircd. Waebingtóo. D.C. 20400. 202.755. 0030. 40 CFR 102 ExemptIon of Nec' flames Drops, Oct. 13, 1970 do - Dane BrasdeWein 118-7061. FIFRA 251e1u21. Thin part would exempt from ` `Olnelronmesstnl Protection Agency. FIFRA penticides that are also new drugs ems' Wgolslngton. D.C. 20460. 203455- axed by FDA. 0037. ~6D8RAL UGIST0R, VOL 43, NO. 231-THU850AT, NOVEM880 30~ 1978 A-41 PAGENO="0358" 352 56170 NOTICES MAJOR EPA REOUL.ATIONS UNDER CONSADERATION'-ContlflUed Idame anddnscrlptianot TegaIation 1rupcaal dMa in P'aronot. flnusnnse Final date in Facanut Rausseaa Contact prison and address Too AccBcw Estate Ac': Proicclit.r Aehus OenfNincs/vr Nacleur £mrceea. S..ptemher 1079 February 1730 Jhu ilaidia (AW.460i rice, AF.A 274th). Thh~h. a gnid~ece fnremccgcc' Ewv)rovmrntul Prwirct)ns Agrn,'p. cy recponnc piano )n thn ascot ala nuclear ccci. Waylvactun. D.C. 20460. 700.097. slant.).:. e7iiucnt mien.,; from a eurirarrca'tor. 8010. Cw.luv.,e ftc' Ocacpuilooul Ruciwsli?cs Expoeat'e. Jauuary 1879 Jar 1979 ...,..... Lou (Oarcla(AW'460). AItA a74h). This guidance a'lO update cniuttng Euv)rwnutcotul Protection Ageocy, ((1601 rad)wdnn ccyupull,usnt cilyosure Omits. fur Wuutulagtoa. D.C. 20480. 703.007. Weaker, at Fyd.'cci faeiiilicn and thwan lacililicu 8224. Inoinnied by Fadaral un.';.at"u. Tcueteurunic £lpp,cnic. AEA 274(h). This guidance Nov. 3. 1077 January 1879 O.orc)on Burley (AW-460i. to Fydcer.l ngvl'aicO cnlat7nhco dwue male limits Euai;owtvental Pmnteetios Agency, for ,ece'.nu ;ityu'ivd Sc. trt.c.;urtaiuin cicmcntu in Weuhingtua. D.C. 2b400. 703.097- tic' a. ~ral nncc'nntncnt. `slap fins) guidance is 6610. l.a bca.gnc4 by thvprvoi.ient. loi .Sivcdu.ds for Hiyh.Z.eccl Rudsu' January 1979 July 1979 Sins Martin lAW 460). 0,11cc' Wu.dcs. dEA 274(h). The mygniulius will Ennienamental Protection Agency, set atc,a'ac.le far eciasuc of radloaclialty to the . Wsshington. D.C. 20466, 703.537- eonir..oma'aa i.. a ecuait of storage of waste lou' 8927. topeu. £r,t'irtav'."ill (`-(beta for Rudioueltee Wades. Nuventher 1970 April1939 Harry PettengllllAW'4601. AEA 2141h. 10..' criteria are general guidance au £nvlmonesental Prots'etion Agrv:y. to what cul;n'.c'ii'.s radionctice wasie and faders Washington. D.C. 20460, 703.997. to he cowt'd.rcd in evaluating disposal modes 6927. sod sits.'a. florida Pkouphnte 7'oiliecys. PIOSA 801. A 1970 January 1979 July 1979 Joe Fltngerald iAWO4601. commitment to the Oucernor of Florida by the Environmental Protection Agency. Administrator requrim EPA to estahlish guide' Wsoldngtoa. D.C. 20460,703-507- lines so to whet to do (1) about etiatieg houses 8224. on uranius "eontamieated" tand; 21 about new cogotrurlion ensuch land. lain ltnsoencsCoissnsouesonctsnloacnv66wAce 40 CI'R 241 Gatdellves for Sulid Wsetr li!sssgc' ~ ..... .. .. - BrseeWeddleiWll"tOOi. cacaO Loudcpcsudiug Procures, RCRA t005lat. Envlroonswutal ProtectIon Agency. These are nonee~ulatory technical guideimrs on Wseltiogtost, D.C. 20400, 202-799- landscaping practices Inc the beneficial use of 9120. solid waste so aoilcondiiionee and plant nutrirot. 40 CPR 250 !Ioeordoas Wnolc Crilecio-Idoulifi' January 1979 _. January1900 Alan Carson iWOO-0610. cation and Listing. RCIOA 3001. These rccuia Envlrociosental Pro'.ectlon ~genry. ta)tts define those wsoteo that 0151 he controlled Woshlooton, D.C. 20460. 202.301. u~dcr tile nationwide hoeaedoun vance manage. 9187. meet program. Ccltem)a are provided him idratify- ing chacactcclsiics ef icvcacdoou waats and It: iinting hazardova woutc. The scicctcd ct'.acaclrrlu' tics are; iprflnhilcty. eorrotiarneos, eaatlt'ity, ned iosidity. Testing procedures are inrluded tar de. termination of whether a waste meets the dc sceibed characterisiins. The meuotation aiso huts certain hszarduus wastes or procesoes which are presumed to generate haeardoun wastes. Also. mrons are provided for demonslru(ion of nonin- closion in tile suhtitleCsyotem. 40 CFR 200 *Sissdu,ds/oe Oesrcslers of Rosen- .;....do _..,. ..,... .40... ....-.--..-.-. HaetyTrsskeimfl"969). 005 Weeks. RCRA 3002 ThIa rrguiation eatab- Eavlronsnentul ProtectIon Agency. lisheo natIonal standards for graematoes of has. Ws5hinglna. DC. 20460. 202-795- aedoua wastes. coarring sods iiemu as record 8187. beeping. eoetalnerisstien aim iaheling. wsste ldentifiratiott. and rcpocting. This emulation also eoetains protisl005 ton a haeardousn'aote 40 CFR 200 Siondocds for f'csesywrleme of Rue. Apr. 28.1970 do ....-... ...-.... Do. oodeoe Wuslrs. RCRA 3003. These e,ctionnl stuodords mute trsmsporlems of hsoamdutts wastes responsible for shipping only properly labeled eootainers aadoaly to permuted facihitiro. 40 CFR 2119 .veondu'ee /nc J0reocdocs iVssie January 1979 40 John8rhnom 8WH-Mk. I'Iestnteac. Slactye sad Din~ocel factilliro.' Ennircumcutsl Prctcetisn Acescy. I4CRA 3004. The stoodns'tin eniuh)inh technical Wuhlngtnn. D.C. 20400. 202-799- pc'cfurmancestondardn lee hvuaedowu von? c man 9200. anement faciltitins, edlafite to opemaaios proc tires, locwlivn. rod deolgu. Tilt' ccl)toitt pest'). 01000 for protection of surface n'atcr, ground watcm. atid nieauvifly. 40 CPR 50 Picnic Ri'~ulniienu Joe Iluoocdwae do do -. Solo Morohssi7h'10-504b. O'oei, l'e.-cifancel, Sloreye, acid Dicpoccl Foci))' Enniron.ocutnt Protection Ara'ory. lies. IOCRA 3000. Tltiu rccilil.tioo coabhuhss WsshlndtOit, D.C. 20460, 202-790- penalt presrccnt no 000arc' unIform control by 9020. Stoles ior EPA) ouce ttouurdooo waste otactuge' meol lacihitirs. FIDISAL 90010790. VOL 43. NO. f31-ThURSDAY, NOVIM$6I 30. 997$ A-42 PAGENO="0359" 353 NOTICES 561'~1 MAJOR EPA I~EOULATIONS UNDER CONSIDERATION-ContinUed Wamesssd doncriptlonsfrtgulation Prspusbt dote In Fnnnzs.Raosaenn Ftnaldatrln Fmsez& Rtossrsn Contact person and address Tate RnuonncnConsrsvvrioo AInDRnI'OOSeY Are 40 CFR 250 Gasdelsnee fur .000tr Ilnva,sleuz Fib. 1,1970. January 0975 Dun DcrkisalWte-5051. Wools Prierams. IICOIA 3000. Theuc' gitidytinvu Enviroontrntat Icotertion Auc'cc.v. arc to acnitt Slates in tSr devvioemrnt of their . Washington. D.C. 20400. 202*'fldi own hsosrdoun waste regulatory programs. The sinS, guitirlinnu also specify minimum rcquirc'tnrntu States must moot in order to he authorized by EPA to imsutement their hazardous waute pro. 40 CPR 200 Notificotioss Spslrm for 110zardcas July Ii. 1070 August 1079 Timothy FirtdnlWnl-265t. Wonle Osnsrnlorn. Transporters. hioure. Tieot. Eovironmyntui Proteeltos Agrory. era, sod Diapoesra. RCRA 30~0. The regulation Washington. D.C. 20409. 202.755. describes the onetime notification requiyeno'nl suits. and diuposets of hazuedsuta waste, which sill bring them to the attention of the prruoes ad. minloterlog RCRA's hazardous waste progrom. 40 CP'R 256 Guideiieieufus'Sloie Solsd Waste Pro' Aug. 26. 1078 June 1079 George Garland 1W51-565l. grants. RCRA 4002lbl. These guidelineu are to Ent'ironmeotal Protection Agency. assIst States in the dnvetnpment sod implemen 202.785-0125. tattoo of solid waste management programa. 40 Cl-N 207 Ce'lleris for Clossifteoiion of SOlid Feb. 0, 1978 July 1070 Kenneth ShuaterlWot.904i. Waste and Dispoout Focillllss. RCRA 4004lui. Enaironmetttal Protection Agen~y. Them criteria provide a basis against witieh solid Wsslsingtoo, D.C. 20460. 202.751. waste land disposal facilities can he evaluated in OttO. order to determine probnbility 0f adverse effects on health orthe environment. Oaidrtises for Fcdeml Proearemenl Praclices. Stephen LlnglelWbs-963l. IOCRA 4002tet. Theae guIdelines will nsuiut Fed. Environmental Protection Agesey. coat ageocies to comply with the RCSOA's re Washington. D.C. 20400. 202.755- Quirement that procured materials be eomposed 9140. of the highest perrcntugn of recovered staterials practIcable: UtdfOeslion of Flp.4sh and Sloe April 1970 July 1979 UseofReeycled Paperio PsperPcodsccs Jane 1079 September 1979 Use of Waste is Coostnselion Pecdacls July 1970 October 1970 ... TnsgTousc0nsseance Cossnos. Ace 40 CO'S 740 to-. resiloe of Cfienalcof Substances December 1978 Mar. 1979. 749 Norbert PagelTS-792t. acid Mixfnres. TOCA 4. These regulations require Ennironmeatal Protection Atency. teslla5 of chemical substances that may peesenl . Washington. D.C. 20460. 202.725. an unreasonable risk to human hruilis or the en 604t. nlronment, orare produced In subalonsial ouanti tIes but are 001 ettl,Portrd by adequate test data. EPA Ia preparing two testing reguistionu: on eu genielty testing and envir000tentui fate tenting. 40 CO'S 720 Premanafsclare Nolificsllos. `I'SCA December 1978 April 1979 Slake SileutTS-794l. 9. Thin regulation will establish she procedure Environmental Prntection Agency, whereby a company wilt notify EPA of its intent Washington, D.C. 20460,202-708- to manufarluresnyw chemical. The regulation 9482. will prescribe the rrquired premnnufaeture noti. fication form, describe the procedure fur EPA review. astd contain tentistg guidslinea. 40 COst 761 PCO's MuuW'aelam and Dials'ibalicn. Juoc 7. 1976 January 1979 Peter PrlncipelTS-094t. TSCA 6. This regulation bans the mhoofoeturlng Environmental Protection Mocogy, and distrIbution of PCSo and products noatsia. Washington. D.C. 20400, 202-799. lngPCSa. 0520. Costed sJPstpbremioated Sipl,enauls. TOCA 6. January 1979 July 1979 LagySlhnld ITS-794l. The regulation would control the use of pulybru. Enwlronsonotni Peoteetton Aeengr. minated biphenyla. Washington, D.C. 20460. 202-705- 5903. Ceslornflaomenrbon Emissions. TSCA 6. This Tobe determined Penal BlnboplTS-704l. regulation wsuld apply to noaaerzaol uses of Environmental Protectiols Alency. cblcroflsorooarbons. Wanhinglun. D.C, 20460. 202-799- 8963. 40 CFR 730 Repoefieg on Sahslosces Serum' May 1079 December t079 Ed SruokslTS-753t. mended for Ti-sOny `rOCA 5191. The regoistion EnvIronmental Protection Agency. esquires reportIng of esisling health and safety Washington, D.C. 20440, 201-701- studies for chemical categories as rerommentdod 0932. for testing, 40 CPR 720 Records of Adt'erse Reaction. TSCA March 1970 October 1879 - Do. me). The regulation requires industry to tt_erp records of allegations of nigaiticant adrFrre besith and ellviroslttcelsf at eractions to Ito chemi. sat products. 40 CFR Pet-edna's for jepoel Noltfis'oiiola. Dt'cc'mber 1970 May 1979 Do. TSCA t2lbl. Thruo roles tell enporters bow and whi's tonshmit etport notifications. 40 CF'S 22 Ccesuliivaccd Rules of Produce Don. Attg. 4, t575,intcrlst final October 1079 - Terrell ltuattEst-2420. coning Use Assessment of Cit'il PgsstlIc'w TSCA Environmental Proteettos A*ency. 16. These rotc's would he promtllznted under the Waahintgtuo, D.C. 29460. 302-799- authority of FlORA 14. RC5tA 3008. Mantle Pro. 0970. tectias I5cacoreh and Sanctuaries Act IMPP.SAI 105. CAA 211, andTOCA 10. (FR Dec. 78-33253 Filea 11-29-78; 8:45 amj FEDERAL REGISTERj VOL. 43, NO. 231-THURSDAY. NOVEMBER 30, 1978 A-43 PAGENO="0360" 354 APPENDIX 5. SUMMARY STATEMENT FROM THE EPA ADVISORY PANEL ON HEALTH EFFECTS OF PHOTOCHEMICAL OXIDANTS January, 1978 Prepared for the Environmental Protection Agency under the supervision of the Institute for Environmental Studies of the University of North Carolina at Chapel Hill. PAGENO="0361" 355 I. Composition of the Panel The Advisory Panel on Health Effects of Photochemical Oxidants (here~ after called the `Health Panel") was convened at the request of the Office of Mr Quality Planning and Standards, U. S. Environmental Protection Agency. The Institute for Environmental Studies, University of North Carolina at Chapel Hill, served as advisor in the selection of panel members and as host for the panel meeting held in Chapel Hill, N. C. on June 7th and 8th, 1977. Panel members were: Carl N. Shy, (Panel Chairman), Director, Institute for Environmental Studies, University of North Carolina at Chapel Hill Stephen M. Ayres, Chairman, Department of Internal Medicine, St. Louis Univeristy School of Medicine David V. Bates, Dean, Faculty of Medicine, University of British Columbia T. Timothy Crócker, Chairman, Department of Community and Environmental Medicine, University of California College of Medicine, Irvine Bernard D. Godistein, Associate Professor, Department of Medicine and Department of Environmental Medicine, New York University School of Medicine John R. Goldsmith, Environmental Epidemiology Unit, California State Department of Public Health Staff and scientists of the U. S. Environmental Protection Agency participated in the discussions of the Health Panel; documents prepared by EPA staff were distributed and, where appropriate, commented on. The conclusions and recommended guidelines for protection of public health given in this summary statement represent a consensus of the panel members only. PAGENO="0362" 356 II. Purpose and Scope of the Meeting The purpose of the panel discussions was to interpret the current state of knowledge on health effects of ozone and other photochemical substances, with the objective of developing a guideline to the Environ- mental Protection Agency (EPA) for the protection of public health. These discussions were prompted by EPA's current program for review and re-assessment of the existing air quality standard for photochemical oxi dants. The panel reviewed studies relating to the following .categories of health effects: A. Human studies 1. Mechanical function of the lung (controlled human exposures) 2. Asthma and lung function in children 3. Athletic performance 4. Other effects: mortality, occupational hazards B. Toxicological studies 1. Experimental infection of animals 2. Morphological abnormalities of the respiratory system 3. Biochemical effects 4. Mutagenic and teratogenic potential 5. Performance and behavioral effects In its discussions, the Panel considered several issues bearing on the overall interpretation of reported studies. Among the major issues were: relative weights to be given to published and unpublished reports, concept of threshold concentrations for effects, human health significance of toxicological data, chemical specificity of the air quality standard ("ozone," "oxidants," "photo-chemical substances") margins of safety, and the health significance of exceeding a stated concentration one or more times. PAGENO="0363" 357 III. Format for Discussion of Health Effects The EPA staff requested the Panel to consider three characteristics of population exposure that bear upon protection of public health: the concentration at which human health risk would be increased, the duration of exposure which Is related to this risk, and the temporal exposure pattern that would be associated with increased risk. In its deliberations on each category of health effects, the Panel addressed the probability that the health effects are induced by exposure to ozone or other photo- chemical substances, the severity of each health effect and the uncertainties of the evidence. IV. Concept of Threshold Concentrations A threshold was defined as a concentration between a no-effect level and the lowest concentration at which a health effect was demon- strated. Identification of a threshold relevant to protection of public health requires evidence for specific exposures that produce no effect as well as exposures that produce effects in susceptible segments of the population. The Panel emphasized that biological reactions to pollutants are not characterized by sharp discontinuities in dose-response relationships, and that demonstration of no-effect levels is dependent upon the sensi- tivity of the measurement of effects and exposure, as well as the selection of the most sensitive groups and reaction systems. Since thresholds will depend upon who is studied and what is measured, it is unlikely that scientific eyidence for a specific effects threshold can be satisfactorily derived from existing data. Limited studies can be performed on groups of unusually sensitive persons. Most experimental studies of humans are PAGENO="0364" 358 performed on small numbers of healthy subjects who do not adequately reflect the range of human sensitivity. Toxicological studies usually cannot utilize appropriate models of. sensitive human popu- lations. Thus, the Panel concurred in the statement that thresholds for sensitive persons are difficult or Impossible to determine experi- mentally, while the threshold for healthy persons or animals Is not likely to be predictive of the response of more sensitive groups. The Panel discussed alternatives to the "threshold concept for arriving at recomended guidelines for protection of public health. An acceptable alternative considered by the Panel was (1) to state at what'level health effects have been demonstrated in population groups, in controlled human exposures, and In experimental animals, (2) to evaluate the relationship between the responses of subjects or animals studied and sensitive segments of the population, (3) to assess the severity of each category of effect, (4) t'o recognize the uncertainty in this body of evidence, (5) to propose guidelines for a margin of safety, given the strength of the evidence, the severity of the effects, and the magnitude of the uncertainties, (6) to recognize that decisions on margins of safety Involve more than scientific evidence. V. Acceptabiliy of Cited Reports In their assessment of evidence from the various sources of information on health effects, Panel members agreed that greater weight should be given to peer reviewed publications than to unpublished reports or reports published without this review.. The Panel felt that the latter category of data should be considered, but could not serve as a major contribution to Its recomeendatlons concerning public health protection. Overall, PAGENO="0365" 359 there was a sufficient body of peer reviewed publications to serve alone as the basis for the Panel's recon~endations. In the one instance where a significant human effect was demonstrated at a low ozone exposure, the, Panel took account of the data but made its conclusion primarily on the basis of other published evidence. VI. Human Studies A. Mechanical function of the Lung The Panel focused its discussion on the more recently published human exposure data as reported by von Nieding, et al. (l977a, 1977b), Hackney et al. (1975a, 1975b, l975c, 1977), Bates and Hazucha (Bates and Hazucha 1973, Hazucha 1973, Hazucha et al. 1973, Hazucha and Bates 1975). The Panel agreed that there was convincing evidence for pro~ nounced effects on mechanical function of the lung, as variously measured by flow rates, airway resistance and other parameters of ventilatory function, at ozone exposures of 0.37 to 0.75 ppm for two hours under conditions of intennittent moderate exercise. The Panel also accepted the validity of findings showing an effect on lung function at 0.25 ppm, but recognized that these effects were less pronounced than at higher concentrations and that they occurred In Montreal subjects and not In Los Angeles subjects studied under i.den~ tical protocols. The difference between the dose-response relationships for Los Angeles and Montreal subjects was felt to be explainable by one or more of the following factors: adaptation in Los Angeles subjects, admixture of submicronic aerosols in the Montreal chamber, and/or selective migration away from Los Angeles of persons who could not tolerate previous repeated ambient ozone exposures without undue reactions. PAGENO="0366" 360 The Panel also identified the fact that a plateau in the dose~response relationship in Montreal subjects was not demonstrated, and therefore that effects may be produced at even lower concentrations than those employed. In support of this hypothesis were the data from recent publications of von Nieding et al. (lglla, l977b). Differences from other study protocols in the measurement of airway resistance and of arterial partial pressure of oxygen were recognized. The small standard, error about mean values of airway resistance was also noted. The Panel felt that these aspects of the von Nieding studies required replication of their results by other investigators but that the data was~!hereby invalidated. The Panel concluded that results of the von Nieding studies served to reinforce the conclusion that changes in mechanical function of the lung may well occur in some subjects at ozone concentrations less than 0.25 ppm for two hours, and that there may be some risk of inducing functional changes at levels in the range of 0.15 to 0.25 ppm. The Panel considered the issue of repetitive experimental exposures, and asked whether effects on mechanical function would be more severe with repetition of exposure or would possibly occur at lower concentrations with repetition of exposure. The Panel consensus was that the risk of effect was related to the total dose of ozone delivered to the respiratory tract within a day (but not over long periods), and that this dose Increased with the frequency of exposures, with the concentrations of a single exposure, and with the intensity of exercise of exposed subjects. The Panel concluded that the evidence for a relationship between ozone exposure and effects on mechanical properties was conclusive. In discussing the severity of this effect, the Panel agreed that one exposure PAGENO="0367" 361 ay not portend risk of serious consequences in healthy individuals. How~ ever, a single exposure of a sensitive individual such as an asthmatic, or other persons with airway disease, may induce a serious health effect, and repeated exposures even of healthy individuals may lead to increased risk of respiratory Impairment In the form of irreversible effects or susceptibility to chronic respiratory disease. However, the Panel recognized that judgments concerning repetition of exposures fall in the area of greatest uncertainty because experimental human studies have not been conducted to evaluate repetitions of exposure. The Panel also cited recent experimental evidence that the maximum stimulus to histamine release in the lung occurred 24 hours after ozone exposure, suggesting that exposed persons with sensitive airways may experience untold delayed effects. These findings are not fully understood and generally have not been incorporated into the assessment of ozone induced health effects. B. Asthma and Lung Function in Children The Panel reviewed the air quality data available for interpreting the findings of the Schoettlin and Landau (1961) asthma study. Although there was some confusion in the early reviews of this study, it is now clear that oxidant measurements for each day were made by the Los Angeles Air Pollution Control District, that these data were obtained by the potassium iodide method, and that there were significantly more asthma epidodes In subjects on days when peak oxidant concentrations exceeded 0.25 ppm, and finally that these peak concentrations were associated with average maximum hourly oxidant concentration of about 0.20 ppm. From these data, the Panel agreed that the evidence supported the statement that a proportion of asthmatics will be affected by maximum PAGENO="0368" 362 hourly oxidant concentrations of 0.20 ppm, and that the effect is likely to occur at concentrations in the range of 0.15 to 0.25 ppm in some asthmatics or other persons with sensitive airways. The Panel also considered the recent reports of Kagawa and Toyama (1975) and Kagawa et al. (1976) on the association of changes in lung function of school children with oxidant exposure. These published reports show a decrease in ventilatory function of school children associated with increasingambient ozone concentrations, from 0.1 to 0.30 ppm. The Panel noted that the authors stratified the data into low and high temperature seasons, but could not isolate the effect of ozone from other measured pollutants, since population exposures only occur in the presence of pollutant combinations, not for single pollutants in isolation. The Panel concluded that these studies further supported the evidence for an increased health risk from ozone exposures over the range of 0.15 to 0.25 ppm, and for the likelihood of a lesser but real health risk at even lower concentrations. The Panel expressed additional concern for ozone exposures of young children, in view of the findings of Bartlett et al. (1974) which demonstrated a reduction in lung elasticity and overdistention of the lungs of rats exposed at 3-4 weeks of age for 30 days to G.2 ppm ozone. The Panel felt that these data were particularly signif~icant since there is continuous growth of lung capacity, in humans, both in terms of number of alveoli and ventilatory function from birth to age 8 or 9 years, and, since ozone exposures which compromise lung development at these ages might have serious implications for risk of impairment later in life. PAGENO="0369" 363 The evidence that ozone effects may be enhanced by other concurrent pollutants (Bates and Hazacha 1973) was interpreted by the Panel as indicating the desirability of providing a margin of safety between these observed effects and the primary standard for ozone and other photochemi cal substances. C. Respiratory and Other Symptoms in Human Populations Experimental exposures of humans and epidemiological observations support the conclusion that ozone exposures in the range of 0.15 to 0.25 ppm are associated with increased risk of cough, chest discomfort, susternal soreness, headache and eye Irritation. Respiratory symptoms are enhanced by more Intense exercise. The Panel judged that the attempts to obtain threshold estimates for these effects (Haraner et al., 1974) violated biological evidence for nonlinear dose-response relationships, and that in general, segmental regression analysis ("Hockay-stick" function) is Inappropriate for determining the onset of health risk. In reviewing the several Japanese reports on acute respiratory and other symptoms In school children during "photochemical smog" episodes, the Panel noted the occurrence of acute effects at ozone levels of 0.15 ppm and above. The Panel attributed the high rate of reporting of symptoms In the Japanese episode to a combination of several factors. (1) biological reactions producing manifest symptoms, particularly * in actively exercising school children, (2) Probable combination of ozone with other pollutants which Interact In their biological effects, (3) sociological factors which In one culture may result in repression of perceived symptoms and in another articulation of perceived symptoms, and ~f3-778 0 - 79 - 24 PAGENO="0370" 364 (4) psycholog4cal factors which may alter the individual `s judgment concerning the severity, of symptoms. One or more of these factors may account for the apparently high incidence of chest discomfort and eye irritation in affected juvenile groups and for the associated extrapulmonary mani- festations such as numbness, fainting and necessity for hospitalization. Thus the Panel concluded that the Japanese reports of symptoms at 0.15 ppm should be given due weight in arriving at a guideline for public health protection. The repetition of these episodes with associated symptoms adds to their significance. D. Athletic Performance The Panels previous coments concerning the inappropriateness of segmental regression analysis was stated to apply to Wayne et al.'s (1967) study of athletic performance. The data as presented in the original study do not suggest a plateau in the dose-response function. Never- theless, some members of the Panel were unconvinced of an association between impaired performance and oxidant concentrations less than 0.15 ppm. However, these members stated that their judgment was based on a visual truncation of data points rather than on quantitative statistical analysis. The Panel noted that a recent paper (Folinsbee et al. 1977) has documented a decline in maximal oxygen uptake in healthy young subjects exercising under controlled experimental exposure to 0.75 ppm ozone, thus suggesting a mechanism for the effect on athletic performance. E. Other Effects: Mortality, Occupational Hazards Review of existing studies fails to show any evidence for increased risk of mortality in association with daily oxidant concentrations measured in the Los Angeles basin. The Panel stated that there was no new evidence to alter this conclusion. The Panel expressed concern with the absence of studies of different groups occupationally exposed to ozone. These groups include airline pilots and crews, workers exposed to coronal discharges in the electric PAGENO="0371" 365 utility Industry, and other persons working in the vicinity of ultraviolet lights, e.g., in cold storage rooms. The Panel was quite convinced that some adverse-reactions would be produced in these occupational settings, and expressed concern that the absence of systematic studies will lead tO continued exposures without identification of the induced health risks. F. Conclusions from Human Studies - The Panel reached consensus on the conclusion that short term exposures to ozone in the range of 0.15 ppm to 0.25 ppm may impair mechanical function of the lung, and may induce respiratory and related symptoms in sensitive segments of the population. These symptoms and effects will be more readily Induced in exercising subjects, particularly in a complex urban atmospheric environment in which ozone can interact with other pollutants. Short term exposures only 3 or 4 times this level, that is, exposures to 0.75 ppm for two hours, can induce severe symptoms in exercising sub- jects. Such experiments are ethically unacceptable. - The Panel judged that the occurrence of respiratory symptoms and alteration of mechanical function of the lung have important public health implications, particularly for the developing lungs of young children. Although such effects appear to be reversible in exposed young adults, they represent a potentially serious risk for asthmatics and other Individuals with airway disease. In the population of individuals with varying states of biological adaptability, exposures which produce the above described effects may at times overwhelm the biological defense of some persons. Thus reversibility of effects in experimentally exposed healthy subjects should not be generalized to the entire population. The Panel related many of the experimental human effects to a two-hour averaging time. However, the Panel noted that more intense exercise was PAGENO="0372" 366 likely to bring about respiratory symptoms and ventilatory function effects within a' period of one hour. Panel members concurredth'at it was not possible to perform a fine tuning on the averaging time associated with this category of effects, and agreed that a one-hour averaging time represented a satisfactory estimate of the exposure duration which should be considered in a primary air quality standard aimed at protection of public health. To sOme extent, a one-hour averaging timemay provide a ~desirable addition to the margin of safety, in that it may better protect actively exercising persons. VIII. Animal Toxicology Studie' ` A. `Experimental Infection of Animals Increased susceptibility to bacterial infection following ozone exposure at 0.1 ppm is described by several investigators (Colfin et al. 1968, Ehrlich et al. 1976, Gardner et al. 1974) in reports that do not fulfill the desi- deratum of peer reviewed publications. These reports are, however, con- sistent with-a larger body of published evidence (Coffin and Gardner 1972, Goldstein etal. l9lla, 1971b, Goldstein and Hoeprich 1972, Goldstein et al.. 1974 and others) that establishes indices of infection or of mortaility from bacterial infection as sensitive measures of the effect of ozone in. rodent lung. Additional stress such as heat, exercise or a combination with other pollutants, according to some reports, may enhance the effect of ozone on susceptibility to infection, and may thereby lower the ozone dose at which the organism will be adversely affected. The Panel agreed that these finding have definite human health implications although an exposue level associated with such effects in humans may be different. These reactions In mice represent basic biological responses to infectious agents, and there is no reason to believe that pollutant induced alterations of basic defense mechanisms in experimental mice would not PAGENO="0373" 367 occur In similarly exposed and challenged humans. However, the Panel Is not aware of epidemiological êvidénce that susceptibility to Infection Increases in persons exposed to ozone and other photochemical materials. However, the biàchemical and cellular alterations described below for rodents suggest that multiple epitheli'al and biochemical targets are perturbed by ozone exposure. Since similar epithellal perturbations occur in humans when viral infection precedes the onset of bacterial pneumonia, it Is reasonable to expect that chemical injury to respiratory epithelium will predispose to infection. Ozone induced irritation of the major bronchi in man does occur at ozone concentrations in the range of 0.25 ppm. Hence It Is possible that ozone damage `at the level of respiratory bronchioles and alveoli occurs in man as well as rodents, leading to promotion of sus- ceptibility to bacterial infection of the lower respiratory tract. The Panel observed that It may be particularly difficult to demonstrate these relationships because bacterial pneumonia is a disease of low incidence, occurring more in the winter season when oxidant concentrations are typically low. It is possible that concentrations of ozone high enough to injure macrophages do not `reach the alveoli in man but do so In rodents because of anatomic differences between human and rodent lungs. In this case, the significance of the animal data on ozone-induced susceptibility to infection lies in the demonstration that a measurable effect on a biologically important system.(defense against infection) occurs in rodents at concentrations that also produce measurable responses in man (altered mechanical function of the lung). B. Morphological Abnormalities of the Respiratory System A range of morphological effects was noted in association with experi- mental ozone exposures of 0.2 to 1.0 ppm. These effects varied from replacement of Type I `with Type II alveolar cells, which are not known to PAGENO="0374" 368 have associated harmful consequences, to enphysematous changes and terminal bronchiole `and alveolar damage. These effects occurring after long-tern low concentrations, raise the level of suspicion that repeated or chrønic exposures have the potential for Inducing similar effects in humans. C: Biochemical Effects The Panel observed that there Is an Impressive variety of biochemical alterations associated with ozone exposures over the range of 0.1 to 1.0 ppm. The Panel judged that effects Induced by 0.1 to 0.2 ppm exposures are probably largely adaptive while effects caused by levels of 0.5 ppm and greater have definite toxic potential. The Panel judged that these biochemical changes are significant in demonstrating that there are ozone-induced effects at cellular sites and organ systems distant from the lung. While many of the biological reactions were In the nature of a protective response and could possibly be prevented or reversed with Increased vitamin E levels in the lung or increased antioxidants at other tissue sites, nevertheless they represented the organism's response to stress. The Panel agreed that such perturbations In biological systems may pose a health risk to the population of impaired or susceptible Individuals. One of the panel members noted that, in experimental studies, Canadian subjects who manifested greater change in mechanical function of the lung than in Los Angeles subjects also showed greater hemolysis of red blood cells. These observations suggest that ozone levels which produce lung function changes can also lead to biochemical changes and other reactions of definite concern to health, and vice versa. Overall, the Panel felt that there is not a sharp dividing line between protective responses and potential for pathological consequences. PAGENO="0375" 369 0. Genetic and Teratogenic Potential S S The Panel focused its attention on the reports of chromosomal abnor- malities in peripheral leukocytes first observed upon exposure of intact hamsters to 0.2 ppm ozone for five hours (Zelac, 1971). One experimental study of humans (Merz et al. 1975) found similar abnormalities in individual~ exposed to 0.5 ppm ozone. The significance of chromosomal aberrations in peripheral blood cells has not been determined. Furthermore these studies have not,been replicated, and the Panel agreed that there was insufficient evidence to evaluate the long term implications of these reports. Although confirmation of the results may suggest another category of ozone-induced effects., the preliminary evidence does not suggest these effects occur at. drastically lower levels of exposure. It was further noted that genetic consequences of population exposures to human.mutagens are very difficult to identify, even for such well recognized mutagens as ionizing radiation. Veninga's observation (1967) of increased neonatal deaths and congenital abnormalities in newborn mice was cited by the Panel as grounds for raising the index, of concern over the potential teratogenic effects of ozone. The evidence for the mutagenic effect of ozone in bacterial systems and lung tumorigenesis was also .noted. The Panel observed that, were similar findings demonstrated for food additives or pesticides, these substances would undoubtedly be banned from use.. E.. Performance and Behavioral Effects . Few experimental studies of performance and behavioral effects of ozone have been reported and the Panel considered this category of effects to be a neglected area of research both in animal and human ozone studies. The effects of ozone and other oxidant exposure on athletic performance. (Wayne et al. 1967) and on motor vehicle accidents (liry 1968) provide epidemiological evidence for impact on performance in humans. PAGENO="0376" 370 F. Implications of Animal Toxicology Data The Panel observed that the ozone dose which caused chronic tissue damage in the lungs of experimental animals was much closer to ambient Concentrations than are the doses of carcinogens employed to produce tumors in laboratory animals. The chronic respiratory diseases related to similar tissue changes in humans were felt to be at least as important, from a public health perspective, as respiratory cancer. Thus, it was noted that the margin of difference between ozone concentrations that produce serious toxicological effects in animals (as well as symptomatic and lung function changes in humans) and ambient levels of ozone is much smaller than for any other atmospheric pollutant. The Panel also emphasized that there was a remarkable clustering and convergence of various toxicological experimental human, and epidemiologically observed effects within a narrow ozone concentration i~ange, that is 0.2 to ~. 6 ppm. These findings further reinforce the judgment that there is not a sharp cut-off for ozone dose- response relationship. The Panel hypothesized that exposures above maximum observed baákground levels of 0.05-0.06 ppm may well be associated with some increased health risk; this perception is based on the convergence of various effects at concentrations minimally above background (less than one order of magnitude). *The Panel pointed out that chronic disease effects of long teflii ozone exposure in man cannot bi quantitatively related to specific ozone concentrations of short (hourly or daily) averaging times due to the long period of disease induction and the varied exposures of indiViduals during the period of induction. Epidemiological studies may establish relation- ships betweefl long-term ozone exposure and human chronic disease risk, but we must rely on toxicological studies to guide us in quantifylngthe ozone level that may induce chronic effects. PAGENO="0377" 371 VIII. `Ozone" vs. `Oxidant" Standard The question was raised by the EPA staff whether the Health Panel felt that an ozone standard or a standard for ozone and other photochemical substances was required for protection of public health. The Panel agreed that two characteristics of ozone exposure should be cited with reference to public health protection: (1) ozone itself is a primary cause of most of the health effects reported in toxicological and experimental human studies and the evidence for attributing many health effects to this substance alone is very compelling, and (2) ozone measurements should be considered as an index for the complex of atmospheric photochemical substances some of which are known to produce health effects which either are not attributable to pure ozone, e.g., eye irritation, or which may possibly augment the effects of pure ozone. The Panel judged that it was not appropriate at this time to consider a primary air quality standard for specific photochemical compounds other than ozone. The Panel agreed that when ozone is measured specifically, in contrast to measurements of total oxidants, it should be considered both as a causal agent of adverse health effects in its own right and as an index for the photochemical mixture which is associated with a broader range of health consequences. Beyond this, the Panel did not reach consensus as to whether the primary air quality standard should be expressed solely as an ozone standard or as a standard for ozone and other photochemical substances. Some Panel members were concerned that a standard for ozone alone would lead some to dismiss epidemiological evidence relating health effects to "oxidant" concentrations and further to discount the occurrence of symptoms and effects not attributable to pure ozone. Other Panel members believed that citing ozone as an index as well as primary agent in its own right would obviate these problems. PAGENO="0378" 372 IX Recommended Guidelines for the Protection of Public Health In considering the margin of safety between concentrations that represent a public health risk and the recommended standard the Health Panel called attention to several conslusions that were previously stated: 1 There appears to be a finite probability of health risk associated with population exposure to ozone concentrations above observed maximum background levels i e 0 05 to 0 06 ppm Specifically there is evidence from studies of ozone and other photochemical oxidants for alterations of mechanical function of lung in humans for exacerbation of asthma in humans for alteration of ventilatory function in school children for induction of acute respiratory symptoms in exercising children and young adults for impaired athletic performance in young adults. The Panel judged, as discussed in the previous sections, that these effects may be induced by short term exposures to ozone in the range of 0.15 to 0.25 ppm. An unreplicated study of airway resistance in humans and repeated studies of susceptibility to experimental respiratory infection in animals further suggest the possibility of adverse effects in some persons at short term ozone exposure of 0 10 ppm 2 In contrast to most other atmospheric pollutants there is a convergence of experimental animal experimental human and epidemiological studies demonstrating effects at relatively low ozone concentrations 0 15 to 0 35 ppm These concentrations represent a relatively small margin of difference between observed minimum background levels and concentrations causing Increased health risks. 3. The implications of these demonstrated health risks are significant to the overall health of human populations. 4 There is new evidence for biological reactions to combinations of ozone with other commonly occurring atmospheric pollutants In reviewing the body of evidence on health effects the Health Panel concluded that there is no compelling reason to suggest a change from the concentration defined by the existing primary air quality standard, namely, 0.08 ppm. This conclusion was based upon the previously cited Panel consensus that a variety of adverse effects are likely to occur in some segments of the population from short-term ozone exposures of ) 15 to 0 25 ppm, and upon other evidence that suggests though less conclusively the possibility of effects at concentrations as low as 0 10 PAGENO="0379" 373 ppm. The Pan& recognized that this standard provides very little margin of safety, for the reasons cited ivmnediately. above. In considering the appropriate averaging time to be associated with this recomended concentration limit, the Panel judged that a one-hour exposure limit would provide some slight margin of safety for exercising individuals, whereas two or three hour exposures at the same level would tend to increase the delivered dose and thus raise the level of risk. Thus the Panel concluded that a primary standard of 0.08 ppm for one hour represents a level of exposure which would be consistent with pro- tection of public health. The Issue of how many times the 0.08 ppm one-hour level could be exceeded without increased health risk was addressed. The Panel agreed that the level of health risk increased (1) in proportion to the hourly concentration above 0.08 ppm, (2) in proportion to the number of hours in one day above 0.08 ppm, and (3) in proportion to the frequency of days in which hourly averages exceed.0.08 ppm, though the latter conclusion was recognized to be quite judgmental and generally lacking in confirmatory studies. Nevertheless, the Panel could cite no medical reason to suggest that any exceedances of the standard were without health risk. In offering its recomendation of a 0.08 ppm one-hour exposure limit * as a guideline for the protection of public health, the Panel proposed that this guideline be considered as a public health objective for developing control strategies, rather than a signal for injunctive legal actions. Excursions above the 0.08 ppm hourly limit should call for evaluation of implementation strategies and not for crisis reactions PAGENO="0380" 374 that are disruptive of normal activities. As previously stated, the level of health risk is judged to be proportional to the concentration, duration and frequency of exposures ab&ve the standard. The Panel is not suggesting that small health risks are acceptable, but that occasional excursions should be evaluated in the context of long term goals and the difficulty of reducing the primary emissions necessary to achieve the standards. Overall, however, the Panel judges that there is now more experimental and epidemiological evidence to be concerned with ozone exposures above the standard than when the standard was originally established, and that this concern should reinforce the determination to implement the control strategies required to achieve the primary standard. PAGENO="0381" 375 REFERENCES Bartlett, D., C. S. Faulkner, and K. Cook (1974). Effect of chronic ozone exposure on lung elasticity in young rats. J. Appi. Physiol. 37:92-96. Bates, D. V. and N. Hazucha (1973). The short-term effects of ozone on the human lung. In National Academy of Sciences, Proceedings of the Conference on Health Effects of Air Pollutants, October 3-5, 1973. Senate Conanittee on Public Works Print Serial No. 93-15. Washington, D. C.: U. S. Government Printing Office, pp. 507-540. Folinsbee, L. J., F. Silverman, and R. J. Shephard (1977). Decrease of maximum work performance following ozone exposure. J. Appl. Physiol. 42:531-536. Coffin, D. 1. and D. E. Gardner (1972). Interaction of biological agents and chemical air pollutants. Ann. Occup. Hyg. 15:219-234. Coffin, D. L., E. J. Blomer, D. E. Gardner, and R. Holzman (1968). Effect of air pollution on alteration of susceptibility to pulmonary infection. Proceedings of the Third Annual Conference on Atmospheric Contaminants in Confined Spaces. Wright Patterson Air Force Base, Ohio. Aerospace Medical Research Lab., pp. 71-80. Ehrlich, R., J. C. Findlay, J. P. Fenters, and D. E. Gardner (1976). Health effects of short term exposures to NO~, - O.~ mixtures. Proc. Internat. Conf. on Photochemical Oxidant Poltutioti and its Control. Raleigh, N. C., EPA Publication #EPA-600/3-77-O0l6, pp. 565-575. Gardner, D. E., J. W. Illing, and D. 1. Coffin (1974). Enhancement of effect of exposure to 03 and NO2 by exercise. (Abstract). Toxicol. Appl. Pharm. 29:130. Goldstein, E. and P. Hoeprich (1972), Influence of ozone on pul- monary defense mechanisms of silicotic mice. Arch. Environ. Health 24: 444-448. Goldstein, E., W. Tyler, D. Hoeprich, and C. Eagle (1971a). Ozone and the antibacterial defense mechanisms of the murine lung. Arch. Environ. Med. 128:1099-1102. Goldstein, E., W. Tyler, P. D. Hoeprich, and C. Eagle (l971b). Adverse Influence of ozone on pulmonary bactericidal activity of murine lung. Nature 229:262-263. Goldstein, E., D. Warshaver, W. Lippart, and B. Tarkington (1974). 03 and NO2 exposure. Arch. Environ. Health 28:85-90. Hackney, J. D., W. S. Llnn, R. D. Buckley, E. E. Pedersen, S. K. Karuza, D. C. Law, and A. Fischer (1975a). Experimental studies on human health effects of air pollutants. I. Design consideration. Arch. Environ. Health 30:373-378. PAGENO="0382" 376 Hackney, J. D., W. S. Linn, J. C. Mohier, C. F. Pedersen, P. Breisacher, and A. Russo (19mb). Experimental studies on human health effects of air pollution. II. Four-hour exposure to ozone alone and in combination with other pollutant gases. Arch. Environ. Health 30:379-384. Hackney, J. D., W. S. Ljnn, D. C. Law, S. K. Karuza, H. Greenberg, R. D. Buckley, and [. C. Pedersen (l975c). Experimental studies on human health effects of air pollutants. IlL Two-hour exposure to ozone alone dnd in combination with other pollutant gases. Arch. Environ. Health 30:385-:390. Hackney, J. D., W. S. Linn, S. K. Karuza, R. D. Buckley, D. C. Law, D. V. Bates, M. Ilazucha, L. D. Penqelly and F. Silverman (1977). Effects of ozone exposure in Canadians and Southern Californians. Arch. Environ. Health 32:110-116. Hazucha, M. (1973). Effects of ozone and sulfur dioxide on pulmonary function in man. Ph.D. Thesis, McGill University, Montreal, Canada, pp. 223. Hazucha, M. and D. V. Bates (1975). Combined effect of ozone and sulfur dioxide in human pulmonary function. Nature 257:50-51. Hazucha, M., F. Silverman, C. Parent, S. Field, and 0. Bates (1973). Pulmonary function in man after short-term exposure to ozone. Arch. Environ. Health 27:183-188. Hanmier, D. I., V. Hasselhlad, B. Portnoy, and P. F. Wehrle (1974). Los Angeles student nurse study. Ddily symptom reporting and photochemical oxidcints. Arch. Environ. Health 28:255-260. Kagawa, J. and T. Toyama (1975). Photochemical air pollution: its effects on respiratory function of elementary school children. Arch. Environ. Health 30:117-122. Kagawa, J., T. Toyama, and N. Nakaza (1976). Pulmonary function tests in children exposed to air pollution. In Clinical Implications of Air Pollution Research, A. J. Finkel and W. C. Duel, editors. Acton, Mass.: Publishing Sciencing Group, Inc., pp. 305-320. Merz, 1., N. A. Bender, H. D. Kerr, and T. J. Kulle (1975). Observations of aberrations in chromosomes of lymphocytes from human subjects exposed to ozone at concentrations of 0.5 ppm for 6 and 10 hours. Mutat. Res. 31:299-302. Schoettlin, C. E. and C. Landau (1961). Air pollution and asthmatic attacks in the Los Angeles area. Public Health Repts. 76:545-548. (Jry, H. (1968). Photochemical air pollution and automobile accidents in Los Angeles. Arch. Environ. Health 17:334-342. Veninqa, T. (1967). Toxicity of ozone in comparison with ionizing radiation. Strahlentherapie (Munich) 134:469-477. PAGENO="0383" 377 von Nieding, G., M. Wagner, H. Lollgen, and H. Krekeler (l977a). Zur akuten wirkung von ozon auf die lungenfunktion des menschen. Proceedings of the VDI Commission Colloquium on Ozone and Related Substances in Photochemical Smog, VDI Report No. 270, Dusseldorf: VDI-Verlag GmbH, pp. l23~l29. von Nieding, G. and H. N.* Wagner (1977b). Experimental studies on the short-tenn effect of air pollutants on pulmonary function in man: two.~ hour exposure to NO2, 03 and SO PAGENO="0384" 378 APPENDIX 6. REVISIONS TO THE NATIONAL AMBIENT AIR QUALITY STANDARDS FOR PHOTOCHEMICAL OXIDANTS Federal Register Preamble: SUMMARY: AVAILABILITY OF RELATED INFORMATION: SUPPLEMENTARY INFORMATION: BACKGROUND SUMMARY OF GENERAL FINDINGS FROM AIR QUALITY CRITERIA FOR OZONE AND PHOTOCHEMICAL OXIDANTS U.S. ENVIRONMENTAL PROTECTION AGENCY Office of Air, Noise, and Radiation Office of Air Quality Planning and Standards Research Triangle Park, North Carolina 27711 January 1979 PAGENO="0385" 379 Title 40-Protection of Environment CHAPTER 1.-ENVIRONMENTAL PROTECTION AGENCY Subchapter C-Air Programs [FRL PART 50-NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS Revisions to the National Ambient Air Quality Standards for Photochemical Oxidants AGENCY: Environmental Protection Agency. ACTION: Final Rulemaking. SUMMARY: In accordance with the provisions of Sections 108 and 109 of the Clean Air Act as amended, EPA has reviewed and revised the criteria upon which *the existing primary and secondary photochemical oxidant standards are based. These standards were promulgated in 1971 (36 FR 8186) and were both set at an hourly average level of 0.08 part per million (ppm) not to be exceeded more than 1 hour per year. On June 22, 1978, EPA proposed changes in the standard (43 FR 26962) based on the findings of the revised criteria. The pro.- posed changes included (1) raising the primary standard to 0.10 ppm, (2) retaining the 0.08 ppm secondary standard, (3) changing the chem.- ical designation of the standard from photochemical oxidants to ozone, and (4) changing to a standard with a statistical rather than deter- ministic form. The final rulemaking will make three further changes in the standard: (1) raising the primary standard to 0.12 ppm, (2) raising the secondary standard to 0.12 ppm, and (3) changIng the definition of the point at which the standard is attained to `when the ~3-778 0 - 79 - 25 PAGENO="0386" 380 expected number of days per calendar year with maximum hourly average concentrations above 0.12 ppm is eqUal to or less than one.' EFFECTIVE DATE: This revision Is effective immediately upon publica- tion. The normal 30-day delay in effectiveness is not required, when, as in this case, a restriction is eased. FOR FURTHER INFORMATION CONTACT: Mr. Joseph Padgett, Director (MD-12) Strategies and Air Standards Division Office of Air Quality Planning and Standards U.S. Environmental Protection Agency Research Triangle Park, NC 27711 Telephone: 919-541-5204 (FTS 629-5204) AVAILABILITY OF RELATED INFORMATION: A docket (Number OAQPS 78-8) containing information used by EPA in revising the standards is available for public inspection and copying between 8:00 a.m. and 4:30 p.m. Monday through Friday, at EPA's Public Information and Reference Unit, Room 2922, Waterside Mall, 401 M Street SW, Washington DC 20460. These materials include the "Air Quality Criteria for Ozone and Other Photo- chemical Oxidants" and "Control Techniques for Volatile Organic Emis- sions from Stationary Sources," both of which were issued simultaneously when this standard was proposed. The control techniques document and staff papers pertaining to the form of the ozone standard, risk assess- ment method, secondary standard, and health panel assessment are available upon request from Mr. Joseph Padgett. Statements of the environmental, economic, and energy impacts of implementing this standard revision are also available upon request from Mr. Joseph Padgett, at the address shown above. The air quality criteria document can be obtained from: 2 PAGENO="0387" 381 Mr. Michael. Berry (MD-52) Environmental Criteria and Assessment Office Office of Research and Development U.S. Environmental Protection Agency Research Triangle Park, NC 27711 Telephone: 919-541-2266 (FTS 629-2266) This preamble describes revisions to 40 CFR Part 50, Appendix H, "Interpretation of the National Ambient Air Quality Standards for Ozone," and Appendix D, "Measurement Principle and Calibration Procedure for the Measurement of Photochemical Oxidants Corrected for Interferences Due to Nitrogen Oxides and Sulfur Dioxide," that are related to the revision of the air quality standard for ozone. In addition, elsewhere in this issue of the Federal Register EPA is promulgating revisions to 40 CFR Part 50, Appendix D, replacing (superseding) the current calibration procedure with a new, superior calibration procedure based on ultraviolet photometry. Revisions to 40 CFR Part 51, substituting the word "ozone" for "photochemical oxidants" throughout that part, and to Section 51.14, pertaining to control strategies, are being promulgated by EPA elsewhere in this issue of the Federal ~~ister. SUPPLEMENTARY INFORMATION: BACKGROUND On April 30, 1971, the Environmental Protection Agency promul- gated in the Federal ~ister~ (36 FR 8186) National Ambient Air Quality Standards for photochemical oxidants. The scientific, tech- nical, and medical bases for these standards are contained in the air quality criteria document for photochemical oxidants, published by the U.S. Department of Health, Education, and Welfare in March 1970. 3 PAGENO="0388" 382 Both the primary and secondary standards were set at an hourly average level of 0.08 ppm not to be exceeded more than once per year. The asthma study cited as evidence for the original standard is based on work by Schoettlin and Landau (1961). As discussed in the June 22, 1978, proposed revision to the original standard, EPA has re~ assessed its conclusions regarding this study. This reassessment, plus the evaluation of medical evidence accumulated since 1970, led EPA to propose, on June 22, 1978, a revised primary standard of 0.10 ppm (43 FR 26962). EPA did not propose a change In the secondary welfare standard at that time. The proposal was accompanied by pub~ lication of revised criteria and control techniques documents, as well as various staff papers relating to the standard itself and to im- plernentation of the standard. EPA solicited written comments on the proposed standard and, to accept oral testimony, sponsored four pub- lic hearings (Washington, D C. -July 18; Altanta, Ga. -August 17; Dallas, Tex. -August 22; Los Angeles, Calif. -August 24). Oxidants are strongly oxidizing compounds, which are the pri- mary constituents of photochemical smog. The oxidant found in larg- est amounts Is ozone (03)~ a very reactive form of oxygen. Oxidants also include the group of compounds referred to collectively as peroxy- acylnitrates (PANs) and other compounds, all produced in much smaller quantities than ozone. Most of these materials are not emitted directly into the at- mosphere but result primarily from a series of chemical reacttons 4 PAGENO="0389" 383 between oxidant precursors (nitrogen oxides and organic compounds) in the presence of sunlight. The principal sources of organic com- pounds are the hydrocarbon emissions from automobile and truck ex- hausts, gasoline vapors, paint solvent evaporation, open burning, dry cleaning fluids, chemical plants and other industrial operations. Nitrogen oxides are emitted primarily from combustion sources such as electric power generation units, gas and oil-fired space heaters, and automobile, diesel and jet engines. The reductions in emissions of nitrogen oxides and organic com- pounds are achieved through Federal and State programs that have been formalized in regulations promulgated under the Clean Air Act. The Federal programs provide for reduction in emissions nationwide through the Federal Motor Vehicle Control Program, the Federal program for control of aircraft emissions, National Emission Stand- ards for Hazardous Air Pollutants, and the development of New Source Performance Standards. The State programs provide, for additional control measures through State Implementation Plans in those areas of the country where the Federal programs are not sufficiently stringent to permit attainment of air quality standards.. LEGISLATIVE REQUIREMENTS AFFECTING THIS PROMULGATION Two sections of the Clean Air Act govern the development of a National Ambient Air Quality Standard. Section 108 instructs EPA to document the scientific basis (criteria) for the standard, and Section 109 provides guidance on establishing standards and review- Ing the criteria. 5 PAGENO="0390" 384 Air quality criteria are required by Section 108(a)(2) to re- flect accurately the latest scientific information useful in indicat-. ing the kind and extent of all identifiable effects on public health or welfare that may be expected from the presence of the pollutant in the ambient air. The Administrator is required to propose, simultaneously with the issuance of these criteria, primary and secondary ambient air quality standards based upon such criteria. The primary standard is defined in Section 109(b)(l) as the ambient air quality standard the attainment and maintenance of which in the Administrator's judgment, based on such criteria and allowing an adequate margin of safety, are requisite to protect the public health. The secondary standard (Section l09(b)(2)) must specify a level the attainment and maintenance of which in the Administrator's judgment, based on such criteria, are requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of the pollutant in the ambient air. These adverse welfare effects, which are discussed In Section 302(h) of the Act, Include effects on soils, water, crops, vegetation, man-made materials, animals, weather, visibility, hazards to transportation, economic values, personal comfort and well-being, and other factors. The Clean Air Act specifies that primary National Ambient Air Quality Standards are to be based on scientific criteria relating to the level that should be attained to protect public health adequately. Considerations of cost of achieving those standards or the 6 PAGENO="0391" 385 existence of technology to bring about needed reductions of emissions are not germane to such a determination, as the words of the Act and its legislative history clearly indicate. Sectipn 109(d) directs the Administrator to complete a review of all existing standards and criteria before the end of 1980 and at 5-year intervals thereafter and to revise them in whatever manner that review reveals is neces- sary. This promulgation is the result of such a review. Assuring attainment and maintenance of ambient air qualjty standards is the responsibility of the States. Under Section 110 of the Act, they are to submit to EPA for approval State Implemen- tation Plans (SIPs) that provide for the necessary legal requirements for sources of the relevant pollutant so as to demonstrate attainment and maintenance of the standards by certain deadlines. In many areas of the country the ambient air quality standards are not being attain- ed, despite the fact that the deadline for attainment has long since passed. As a remedy, Part D of the Act requires states. with viola- tions of ambient air quality standards to submit revised SIPs to ensure attainment of the standards and to meet certain new require- ments of Part D by January 1, 1979. (Section 129(c), Pub. L. 95-95, note under 42 U.S.C. 7502.) The Act does not authorize the Admini- strator to extend that deadline, and consequently this revision of the photochemical oxidant standard does not affect the. deadline for submittal of SIP revisions. 7 PAGENO="0392" 386 Section llO(a)(l) requires that SIP revisions be submitted within 9 months after a standard is revised. However, this provision refers to situations where a standard Is tightened, with the result that existing SIPs are no longer adequate to attain and maintain the standard In question. Where a standard is relaxed, no SIP revision isrequired by the law, since states may have more stringent controls than necessary if they choose. Furthermore, the change in the chemical species designation of the standard from photochemical oxidants to ozone does not make this standard subject to the provision of Section llO(a)(l) cited above. The intent of the standard (total oxidant reduction), the* control strategies, and the index of progress toward attainment (measured ozone levels) remain unchanged. SUMMARY OF GENERAL FINDINGS FROM AIR QUALITY CRITERIA FOR OZONE AND PHOTOCHEMICAL OXIDANTS On April 20, 1977, EPA announced (42 FR 20493) that it was reviewing and updating the 1970 criteria document for photochemical oxidants in accordance with provisions of Section 1O9(d)(l) of. theClean Air Act as amended. The notice called for information and data that would be helpful in revising the `document. In- preparing the criteria document, EPA provided a number 0f opportunities for external review and comment. Two drafts of the document have been 8 PAGENO="0393" 387 made available for external review, and EPA received more than 50 written comments on the first draft and approximately 20 on the second draft. The American Petroleum Institute has submitted exten~~ sive information that EPA considered in this standard review. The criteria document was the subject of two meetings of the Subcom- mittee on Scientific Criteria for Photochemical 0~1dants of EPA's Science Advisory Board. Each of these meetings was open to the public, and a number of individuals presented both critical review and new information for EPA's consideration. A full discussion of comments received during the review process, as well as EPA's disposition of these comments, can be found in the docket (OAQPS 78-8) assembled for this rulemaking. From EPA's review of the scientific information presented in the criteria document, several key areas with particular relevance to setting the ozone standard have emerged: 1. Threshold concept -- Although the concept of an adverse health effect threshold has utility In setting ambient air quality standards, the adverse health effect threshold con- centration cannot be identified with certainty. The lowest concentration which causes measured health effects in a 9 PAGENO="0394" 388 scientific experiment depends on the particular subjects who have been studied because sensitivity to pollutants varies among dlf~ ferent members of the population. Only limited studtes can be performed on groups of unusually sensitive persons. Most experi.. mental studies of human subjects are performed on small numbers of relatively healthy persons who do not fully reflect the range of human sensitivity. Also, the air to which the subjects are exposed does not Include the full mix of chemicals other than the pollutant being studied which are In the ambient air, Some of these chemicals may be additive with the given pollutant In causing the idverse health effect, so that lower levels of the pollutant will result in the effect. Animal exposure studies cannot provide precise models of sensitive human populations. Thus, adverse health effect thresholds for sensitive persons are difficult or Impossible to determine experimentally, while the threshold for healthy persons or animals is not likely to be predictive of the response of more sensitive groups. In this notice of rulemaking EPA uses the terminology "probable effects level" to refer to the level that in Its best judgment is most likely to be the adverse health effect threshold concentration. It Is the fact that the adverse health effect threshold concentration Is actually unknown that necessitates the margin of safety required by the Act. 2. Ozone health effects -~ Ozone Is a pulmonary Irritant that affects the respiratory mucous membranes, other lung tissues and respiratory functions. Clinical and epidemlological studies have demonstrated that ozone impairs the normal mechanical function of 10 PAGENO="0395" 389 the human lung and causes clinical symptoms such as chest tightness, coughing and wheezing. These effects may occur in sensitive indi~. viduals, as well as in healthy exercising persons, at short-~term ozone concentrations between 0.15 and 0.25 ppm. The clinical studies data base for these effects is far more extensive than that. which was available in 1970, and these effects have now been demonstrated at lower levels than those cited in the 1970 criteria document. 3. Effects on asthmatics The best available evidence suggestS that an elevated proportion of asthmatics experience attacks on days when the peak hourly oxidant concentrations reach about 0.25 ppm. .This finding is based on a reevaluation of the study by Schoettlin and Landau (1961). 4. Toxicologic.findiflgs The key finding from toxicologic studies is the increased susceptibility to bacterial infection in laboratory animals exposed to 0.10 ppm ozone and a bacterial challenge. Infection rates are lower for animals' exposed only to the bacterial challenge. Other effects such as biochemical changes, morphological abnormalities, and genetic changes have been found in some studies of animals exposed to ozone concen trations as low as 0.1 to 0.3 ppm. While the data from animal studies cannot be directly extrapolated to man, they can be taken as indicators of the full range of effects that may occur in humans. The epidemiology study by Durham (1974) that reported increased rates of illness in college students following 11 PAGENO="0396" 390. periods of elevated air pollution levels (with peak oxidant being the pollution variable most strongly associated with illness) further increases our concern regarding the implications for man of the animal study findings.. 5. Ozone effects on aging p~rocesses A limited amount of data suggests that ozone may accelerate the aging process in living organisms. Exposure of rabbits to unspecified concentrations of ozone for 1 hour per week for a year has been reported to induce premature aging symptoms such as premature cartilage calcification, severe depletion of body fat, and general signs of aging (Stokinge', l965)~ 6. Pollutant interactions The fact that ozone exposure is frequently accompanied by exposure to other pollutants, such as sulfur dioxide (SO2), has prompted several investigators to conduct laboratory evaluations of exposure of human subjects to combinations of 03 and other pollutants, Simultaneous ex~ posures to 0.37 ppm 03 and 0.37 ppm SO2 were reported to pro~ duce larger changes in pulmonary function than exposure to either pollutant alone. No obvious effects were observed in other simultaneous exposure tests using 0.25 ppm 03 and 0.3 ppm nitro~. gen dioxide (NO2), as well *as O3~ NO2, and 30 ppm carbon mono~ xlde (CO). Nevertheless, the SO2 - 03 synergism findings sup- port the need for an adequate margin of safety in the ozone standard. . 7. Mortality studies No studies have conclusively linked exposure to ozone or photochemical oxidants with an increase In PAGENO="0397" 391 hum~n mortality. A number of epidemiologic studies have been designed and conducted to demonstrate this effect, but in each case the results have been negative or inconclusive. 8. Welfare effects Ozone accelerates the aging of many materials, resulting in rubber cracking, dye fading and paint erosion. These effects are linearly related to the total dose of ozone and can occur at very low levels, given long-duration exposures. Damage to vegetation, as expressed by decreased growth and yield, is related to the long-term (growing season) mean of the daily maximum 6-. to 8-.hour-average ozone concentrations. 9. Causes and control of oxidant pollution All presintly available evidence indicates that around urban centers with severe oxidant problems, the major concern Is the formation, Of photochemical oxidants from man-made organic and nitrogen oxide emissions. Control of these emissions will result in signifi- cant reductions in ambient ozone, peroxyacetylni trate (PAN), aldehydes and photochemical aerosol. As is the case with most standard-setting activities, the data base on ozone will continue to expand after the standard is set. EPA will continue to inform I tsel f of new research results and also will accelerate the schedule forits own research on the health effects of ozone and other photochemical oxidants at low exposure levels. The Agency plar~s to make the results of these studies available as they are completed and to Issue an interim report on all new research results in two years. - 13 - PAGENO="0398" 392 APPENDIX 7 CHRYSLER CORPORATION L. TERRY May 23, 1979 The Honorable Jerome A. Ambro Chairman, Subcommittee on Natural Resources & Environment Committee on Science and Technology U. S. House of Representatives 2319 Rayburn House Office Buildina Washington, DC 20515 Dear Congressman Ambro: The purpose of this letter is to try to put some perspective into the arguments over the proper ambient air quality standard for ozone. The reason I'm writing now is because I jest recently read the testimony of Dr. James Pitts which he gave before your subcommittee on February 15 in which he urged that the ozone standard be left at .08 ppm. The reason he cited for his opinion is that the Los Angeles smog is sometimes unpleasant at measured ozone levels of .08 ppm. Let's face it, ozone alone is not a good thing to measure to determine the harmful effects of smog. EPA itself admits that ozone is not a "surrogate" for other oxidants with respect to health' effects. On the other hand, neither is total photochemical oxidant necessarily the thing to measure or the thing that causes the health problems noted in some cities. The recent National Academy of Sciences report on Ozone and Other Photochemical Oxidants stated that, even in Los Angeles, no statistically significant correlation could be found between oxidant levels and mortality from chronic illness, hospital admis- sions, or even asthma attacks. We know that ozone by itself doesn't show any har~iful effects and is not even an eye irritant below 0.25 ppm. If something in the air is impairing the health of Angelenos at ozone concentrations below 0.12 ppm, it's up to health researchers to find Out what those harmful compounds are, and to come up with a practical means of finding out what minimum concentrations cause problems. As Dr. Pitts put it, you can't regulate a compound until you measure it. Neither can you impose a reasonable standard until you measure a compound and determine what concentration of that compound creates an unreasonable health effect. Of course, there's the possibility of negative synergistic effects among all the pollutants present in LA smog, but there is also some evidence of adaptive increased tolerance to ozone and even cross-protection between ozone and other irritants. It's up to the health research people to find out the facts -- not PAGENO="0399" `.393 simply to insist on a lower ozone standard when they themselves admit that ozone is not the problem. The health research people complain about their difficulties in finding money to study requlated pollutants, yet they appear totally blase about setting an overly conservative ozone standard that will cost the people of this country billions of extra, inflationary dollars -- something that may literally affect the public health a lot more adversely than a few cases of eye irritation per year. The big problem is the ozone standard is being applied over th~ whole United States, where ozone is almost always found with far les~ of the other harmful elements in LA smog. Advocating lower standards than 0.25 ppm for ozone may make sense for Los Angeles, where ozone may often be only half the total oxidant level, but it is certainly neither relevant nor fair to the rest of the country. Sincerely yours, CHRYSLER CRPORATION /~1/! S.'L'.1Terry Vice President Public Responsibility and Consumer Affairs /ks P.S. If it's not too late, I would appreciate it if you could get this letter in the hearing record. 0 PAGENO="0400"