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S. HRG. 102-252
SAFETY OF PESTICIDES IN FOOD ACT OF 1991
HEARING ~ "~~?
OF THE
COMMITTEE ON
LABOR AND HUMAN RESOURCES
UNITED STATES SENATE
ONE HUNDRED SECOND CONGRESS
FIRST SESSION
ON
S. 1074
TO AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO REVISE
THE AUTHORITY UNDER THAT ACT TO REGULATE PESTICIDE CHEMI-
CAL RESIDUES IN FOOD
JULY 10, 1991
Printed for the use of the Committee on Labor and Human Resources
U.S. GOVERNMENT PRINTING OFFICE
47-693 WASHINGTON : 1991 ~ -~j3 G
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-035800-0
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COMMITTEE ON LABOR AND HUMAN RESOURCES
EDWARD M. KENNEDY, Massachusetts, Chairman
ORRIN G. HATCH, Utah
NANCY LANDON KASSEBAUM, Kansas
JAMES M. JEFFORDS, Vermont
DAN COATS, Indiana
STROM THURMOND, South Carolina
DAVE DURENBERGER, Minnesota
THAD COCHRAN, Mississippi
CLAIBORNE FELL, Rhode Island
HOWARD M. METZENBAUM, Ohio
CHRISTOPHER J. DODD, Connecticut
PAUL SIMON, Illinois
TOM HARKIN, Iowa
BROCK ADAMS, Washington
BARBARA A. MIKULSKI, Maryland
JEFF BINGAMAN, New Mexico
PAUL D. WELLSTONE, Minnesota
NICK LITrLEFIELD, Staff Director and Chief Counsel
KRISTINE A. IVERSON, Minority Staff Director
(II)
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CONTENTS
STATEMENTS
WEDNESDAY, JULY 10, 1991
Page
Wargo, John P., professor of public policy and environmental studies, Yale
University, New Haven, CT; and Dr. Richard J. Jackson, chairman, Ameri-
can Academy of Pediatrics Committee on Environmental Hazards, Sacra-
mento, CA
Prepared statements of:
Mr. Wargo 9
Dr. Jackson 26
Kassebaum, Hon. Nancy Landon, a U.S. Senator from the State of Kansas,
prepared statement 36
Fisher, Linda J., Assistant Administrator, Office of Pesticides and Toxic Sub-
stances, U.S. Environmental Protection Agency, Washington, DC; Fred R.
Shank, Director, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, Washington, DC; and Daniel D. Haley, Administra-
tor, Agricultural Marketing Service, U.S. Department of Agriculture, Wash-
ington, DC
Prepared statements of:
Ms. Fisher
Mr. Shank 52
Mr. Haley 57
Hathaway, Janet, senior attorney, Natural Resources Defense Council, Wash-
ington, DC; Enrique J. Guardia, senior vice president of scientific relations,
Kraft General Foods, on behalf of the National Food Processors Association,
Washington, DC, accompanied by Clausen Ely, counsel; Sherwin Gardner,
senior vice president, science and technology, Grocery Manufacturers of
America, Washington, DC; and Jay Vroom, president, National Agricultur-
al Chemicals Association, Washington, DC 67
Prepared statements of:
Ms. Hathaway 70
Mr. Guardia 91
Mr. Gardner 97
Mr. Vroom 101
Chemical Producers and Distributors Association, prepared statement 109
National Corn Growers Association, American Soybean Association, National
Association of Wheat Growers, National Barley Growers Association, and
the National Cotton Council, joint prepared statement 113
National Council of Farmer Cooperatives, prepared statement 117
National AgriChemical Retailers Association, Larry Thomsen, president, pre-
pared statement 114
American Frozen Food Institute, prepared statement 128
U.S. Chamber of Commerce, prepared statement 130
United Fresh Fruit and Vegetable Association, prepared statement 131
ADDITIONAL MATERIAL
Communications to:
Kennedy, Hon. Edward M., a U.S. Senator from the State of Massachu-
setts, from Chris Myrick, director, legislative/regulatory affairs, Na-
tional AgriChemical Retailers Association, dated July 11, 1991 116
(III)
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SAFETY OF PESTICIDES IN FOOD ACT OF 1991
WEDNESDAY, JULY 10, 1991
U.S. SENATE,
COMMITTEE ON LABOR AND HUMAN RESOURCES,
Washington, DC.
The committee met, pursuant to notice, at 10:12 a.m., in room
SD-430, Dirksen Senate Office Building, Senator Edward M. Ken-
nedy (chairman of the committee) presiding.
Present: Senators Kennedy, Dodd, Simon, Hatch, Kassebaum,
and Cochran.
OPENING STATEMENT OF SENATOR KENNEDY
The CHAIRMAN. The committee will come to order.
Today's hearing addresses the safety of the Nation's food supply.
The measure before us, the Safety of Pesticides in Food Act of 1991,
would institute long overdue reforms in the Federal regulation of
pesticide residues. These reforms are designed to provide a greater
protection for the public, especially children, from the hazards of
pesticides.
The Federal Government has not been doing an adequate job of
protection in this area, and the American people know it. It is un-
satisfactory that families cannot receive a definitive response that
the food on their tables is safe. The debate over pesticides can
easily become a sea of numbers, confusing to Congress and citizens
alike. What we need is a credible system to regulate pesticides, and
we need it soon.
Under current Federal regulations, residues from over 300 pesti-
cides are permissible on the food we eat. Up to 25 percent may
cause cancer in animals. What does this mean for human health?
We don't know-and that is the problem.
Two basic principles underlie this legislation. The public has a
right to demand of chemical manufacturers, the food industry, and
Government: If you don't know what the health risks of a pesticide
are, find out. Once you determine that the risk is substantial, take
the product off the market.
In 1976 I sat on the Judiciary Committee's Subcommittee on Ad-
ministrative Practice and Procedure, which issued a report detail-
ing the inadequate health and safety database for pesticides. Now,
15 years later, we still have serious doubts about which pesticides
are safe and which are not. It is unacceptable when it takes dec-
ades-not years-to resolve basic questions about food safety.
(1)
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The bill I have introduced establishes a standard specifying that
pesticide residues on food cannot exceed levels that contain more
than a "negligible risk" of causing adverse human health effects.
An important provision of the bill establishes a mechanism to
assure that infants and children up to the age of 5 are not exposed
to more than a negligible risk from pesticides. Over the 4th of July
recess, I noticed that many of my young relatives were eating large
numbers of apples and bananas, and I wondered whether they were
consuming residues that might harm them. I want to be sure that
our regulatory system protects the safety of all children.
Because of their food consumption patterns and low body
weights, children can receive a disproportionate share of lifetime
cancer risk from a pesticide at an early age. Also, since latency pe-
riods are so crucial in determining cancer risk, exposures in chil-
dren pose the greatest potential harm. This bill will prevent the
unacceptable front-end-loading of risk.
There are also concerns about other toxic effects of pesticides. As
the American Academy of Pediatrics noted in expressing its sup-
port for a "children's standard", the tissues and organs of young
children under 5 are "exquisitely sensitive" to toxins, and exposure
in early years can cause permanent and serious health effects. We
cannot consider the food supply to be truly safe unless we are con-
fident that it is safe for infants and children too, and this bill will
take a major step toward that goal.
The bill also requires timely decisions about pesticide tolerances,
and tolerance decisions must be supported by scientifically sound
data. By simplifying the procedures for removing unsafe pesticides,
the legislation ensures that the status quo will no longer favor pes-
ticides for which there is incomplete or unreliable data.
The restoration of public confidence in the food supply will serve
the interests of farmers, the food industry and chemical manufac-
turers as well as consumers. Everyone loses when we face intermit-
tent panics which do nothing more than show the failure of our
current system and the mistrust of the public in Government's
claim that there is no need to worry.
The need for action is obvious, and it is up to Congress and the
administration to respond.
Senator Hatch.
OPENING STATEMENT OF SENATOR HATCH
Senator HATCH. Thank you, Mr. Chairman.
I am pleased that we are continuing our discussions on the need
to revise our Nation's food safety laws, and I look forward to the
testimony of these witnesses here today.
For over a decade I have sought changes in the food safety laws,
and I think we have to be aggressive in resolving any conflicts
among consumers, producers, processors, etc.
During the last session of Congress, there were fruitful discus-
sions. The Bush Administration proposed meaningful and good leg-
islative policies to revise the Federal Food, Drug and Cosmetic Act.
Senator Kennedy and I participated in these discussions, and we
nearly formulated a bipartisan agreement. I hope that this Con-
gress will finally be able to forge a bill.
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If I could craft a bill to change the food safety laws, I believe
that we must start at the basics. The American consumers want to
know that their food supply is safe. I believe there are two pillars
that must be constructed to restore consumer confidence.
First, we must establish a strict and uniform food safety stand-
ard that is based on sound science, the best available science, in en-
suring that our products only pose a negligible risk of harm.
Our current law, which utilizes a "zero risk" standard, is no
longer scientifically feasible. Further, this Delaney paradox is
working to keep safer products off the market which could replace
older, less safe products. Every Commissioner of the Food and Drug
Administration for the past 29 years has called on Congress to
remove the rigidity of the Delaney clause. The current Commis-
sioner, David Kessler, has already shown his commitment to a safe
and reliable food policy for this country with his actions on any
possible mislabeling of food products.
These past commissioners are scientists, appointed by presidents
of both parties, who recognize that we must have workable, scien-
tifically accurate Federal laws in order to protect the safety and
health of American consumers.
The second pillar we must construct is to pass stronger enforce-
ment laws that allow the removal of unsafe products with prudent
dispatch. Our current system requires a process which takes four
to 8 years before a product can be suspended or canceled for use.
That is too long, and it is not surprising that States are now under-
taking efforts to protect their citizens because our Federal laws are
so erratic. Rather, we need a strict and uniform safety standard
with strong enforcement tools so that we protect citizens in Utah
as well as the citizens in Massachusetts or any other State.
I recognize that there will be give and take. And I want to par-
ticipate in those discussions, and I am prepared to resolve them.
And, after we complete our action we will need to involve the Agri-
culture Committee in resolving the FIFRA modifications.
I urge you, Mr. Chairman, to resume these negotiations because
there is no more important consumer need than ensuring our food
safety laws provide adequate protection for Americans.
Again, I look forward to the testimony of the witnesses today,
and I urge my fellow members of the committee to listen to the
men and women who have come before us today. I think that we
will hear a clear message that science has taken us to a new realm
and that we must abandon the "zero risk" standard for one of
more reasonable application.
I thank you for holding these hearings and appreciate the leader-
ship you have provided in this area.
The CHAIRMAN. Thank you. I certainly want to underscore what
Senator Hatch has mentioned. We worked closely together during
the last Congress with the administration, and I think that if we
hadn't had the rush of the adjournment there was a good possibili-
ty that we might have made some important progress. I am not
quite sure we would have met all of our responsibilities, particular-
ly with regard to the children's issues that have emerged into
greater profile. Still, we certainly look forward to working with all
the members of the committee this Congress.
Senator Simon.
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OPENING STATEMENT OF SENATOR SIMON
Senator SIMoN. Thank you, Mr. Chairman. I want to join Senator
Hatch in commending you, and I also want to join you in com-
mending Senator Hatch. The two of you have provided solid leader-
ship in this area, and I think it is extremely important.
We clearly have to do a better job. We are doing a better job
than we were decades ago, but we have to do a still better job, in
protecting the safety of our food and in restoring public confidence.
I am particularly pleased that the legislation hits on the aspect
of children and that our testimony today will do that.
I'm not sure whether we are going to get into the other areas of
concern that I have, and whether this is the vehicle for them, but I
am concerned about a couple of other things. I visited a migrant
camp over the 4th of July recess and was told about migrant work-
ers getting sick from pesticides. We have to protect them. But the
very pesticides that can make migrant workers sick-what does
that do to the people who consume these foods?
I don't know the answer. Maybe there is no relationship-but
maybe there is.
I am also concerned that we permit the exportation of pesticides
that we do not permit farmers to use here in our country. Why
should we permit pesticides to be sent to Mexico or Chile or any
other country if we say they are not safe for the people of the
United States?
And in that connection, how do we then protect the safety of food
that we bring in from Mexico or Chile, or other countries? I re-
member taking up with the former head of the FDA the whole
question of safety of imported food,, who said that we just don't
have the resources to provide even token protection for the Ameri-
can public.
I think we do need some strengthening of the laws in this area,
or at least some improvement of how we enforce the present laws.
But these are areas that I assume we can get into during the tes-
timony. Mr. Chairman, I thank you for once again providing solid
leadership in an area to protect the public.
The CHAIRMAN. Thank you very much, Senator Simon.
For our first panel, we are pleased to have Professor John Wargo
from the Yale School of Forestry and Environmental Studies, as
well as Richard Jackson, chairman of the American Academy of
Pediatrics Committee on Environmental Health.
Professor Wargo, welcome.
STATEMENTS OF JOHN P. WARGO, PROFESSOR OF PUBLIC
POLICY AND ENVIRONMENTAL STUDIES, YALE UNIVERSITY,
NEW HAVEN, CT; AND DR. RICHARD J. JACKSON, CHAIRMAN,
AMERICAN ACADEMY OF PEDIATRICS COMMITTEE ON ENVI-
RONMENTAL HAZARDS, SACRAMENTO, CA
Mr. WARGO. Thank you, Senator Kennedy.
I am honored to appear before you today to discuss the merits of
proposed changes in legislation. I am appearing today as a faculty
member at Yale University, where I hold appointments in the
school of forestry and environmental studies, the political science
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5
department, and where I am director of undergraduate studies for
Yale College's New Studies in the Environment Program.
My appearance today is conditioned by several important reser-
vations. I have been working with the National Academy of Sci-
ences Committee on Pesticides in the Diets of Infants and Children,
which has been charged by Congress and EPA with the task of de-
termining if children are sufficiently protected from potentially
harmful exposures to pesticides by current law. In an ideal world,
Senator, the committee's conclusions and recommendations would
be available for presentation today. Obviously, this is not the case.
The comments I am making today reflect only my own opinions.
I am not a spokesperson for the committee. Also, I must refrain
from divulging findings, conclusions and recommendations of this
committee, which may make it in the future necessary for me to
decline to respond to certain specific questions. And if I sense a
conflict between the question and the possibility of disclosing these
findings, I hope you will understand.
The CHAIRMAN. We appreciate that. There are many important
areas of public policy that are being addressed by the National
Academy of Sciences, and all of us value very much the conclusions
the academy will reach. But, many of those individuals who are
most knowledgeable are on various panels, and we have a responsi-
bility in terms of the timeliness of public policy questions. So we
certainly respect your position, but we know that your knowledge
as well as Dr. Jackson's has been built upon a long lifetime of con-
cern for these issues, and that's really what we are interested in
drawing upon here.
Mr. WARGO. Thank you. The data that I am going to present
today is actually data that was compiled before the National Acad-
emy of Sciences committee was put together, and as you have sug-
gested, I have been working in this area for nearly a decade.
If you carefully look at the 1977 and 1978 food consumption
survey developed by the Department of Agriculture, and you break
that survey down, looking at food consumption patterns by chil-
dren and compare them to adults, some rather striking results
occur.
Kids have a much lower level of dietary diversity than adults do.
They simply eat fewer foods, and therefore they eat more of those
fewer foods. They eat more; their consumption is higher per unit of
body weight than for adults for fruits and vegetables in particu-
lar-apple juice, orange juice, milk products, apples, peaches,
pears, plums and bananas.
In fact, if you look at the first chart on your right, you will see a
simple graph of consumption of apple juice over different age peri-
ods. The "x" axis shows us ages one, 2, 3, on up through 20, and at
the end you see U.S. average consumption. You see that the zero-
to-i year-old consumes 3.3 grams per kilogram body weight per day
of apple juice, compared to the 20 year-old, who consumes about .3.
So there is a substantial difference in the intake of foods, par-
ticularly fruits and vegetables, as well as liquids.
Another important point here is that no one eats an average
amount of food. And EPA, in their exposure estimation process,
when they try to figure out how many chemicals we are exposed to
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and at what levels, particularly for chronic cancer risk assessment,
would presume an average intake value over a 70-year period.
No one, from the data that I have looked at, eats an average
amount of every food. In fact, people eat higher amounts of fewer
foods.
There are several substantial limitations to the consumption
data that we have available to us today to estimate exposure. The
current consumption data set is a three-day survey conducted in
1977 and 1978. So right off the bat, you understand that this survey
data is now 13 or 14 years old. And with the changes in food tech-
nology, changes in marketing techniques, changes in simply taste,
you find rather dramatic differences across time.
Another limitation is that we're not tracking individuals' con-
sumption patterns over time. So we are not tracking "Jane Doe"
from age one to age 10, so we don't really know how that individ-
ual's consumption is changing. Instead, we do a one-time survey,
say in 1978, and then we look at individual age classes and then
attempt to project out over long periods of time what the risk
might be.
Now, remember that the tradition in cancer risk assessment is to
project risks out over a 70-year period. My argument is that we cer-
tainly don't want to use data that is that old to protect our risks
over such a long period of time. Part of my expertise lies in the
area of computer modelling, and one of the maxims of computer
modelling is that you don't model or forecast into the future fur-
ther than your data would permit, or looking back too far at the
data trying to project too far into the future what the risk might
be. This is a serious problem.
Let me mention several residue issues. In my mind, of the three
major components of the risk equation-consumption data, residue
data and toxicity data-the consumption data is in the best shape;
residue data is not in good shape. The limitations are primarily re-
lated to the fact that FDA collects data for the purposes of moni-
toring and enforcement-not for the purposes of exposure assess-
ment. So that the sample, the survey design, is not statistically ap-
propriate for estimating exposure of the general population to pes-
ticides, let alone exposure of small children to pesticides.
We have very little knowledge about distribution of foods, track-
ing where they are grown, what pesticides are used on them, and
where they end up. Also, EPA is constantly struggling under budg-
etary constraints in their attempts to figure out what happens to a
residue when it moves from a raw food such as apples to a proc-
essed food form on apple juice. They often require detailed tests to
be able to tell them whether or not the residue values are concen-
trating or diminishing.
The data sets are also plagued by small sample sizes. If you take
a look at the 300 foods, Senator, that you mentioned-or, 300
chemicals on, say, 376 different foods-you find that for a single
chemical on a single food, often the sample size of residue is far too
small to be able to project back exposure estimates on the entire
population.
I am going to let my colleague, Dick Jackson, talk about toxicity
issues in the interest of time.
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The basic reason this committee has convened here today is to
try to come to a conclusion about whether or not the current stand-
ard is reasonable. Is the Delaney amendment, the zero risk stand-
ard, a reasonable way to approach this problem?
My argument is that, no, it is not, and let me offer you several
options as potential solutions.
You could set a health-based standard, an acceptable level of
risk, and it has become a term of art or a tradition in Washington
now to talk about a 10 to the minus 6th risk or a one in a million
risk. That presumes that a person is exposed for an entire lifetime.
Their chance would increase by one in one million of gaining a
tumor at some point during that period.
Well, where do you want to set this standard? This is a critical
question. Do you want to set this standard based on a single chemi-
cal and a single food-say, alar in apple juice, or benamil on toma-
toes. If you do that, you are going to allow risk to build up across
all of the chemical food combinations that exist in the system. If
you go to the Code of Federal Regulations, and you look at how
many chemical food tolerances are on the book, the last time I
checked it was 8,843. So are you going to allow a 10 to the minus
6th risk to accumulate over 8,843 different cases? My argument is
no, and nobody is arguing that that should be the case.
Option number two is to set that standard, 10 to the minus 6th,
per chemical, and say that all of the uses of benamil or aldicarb-
not aldicarb; it's not an oncogen-benamil or, say, alar should not
result in a total risk greater than 10 to the minus 6th. In fact, that
is commonly thought to be a very reasonable solution to this
problem.
However, remember again there are 320-odd food use chemicals
that are permitted for use in the food supply, and if you define the
standard as 10 to the minus 6th or one in one million per chemical,
then you basically are not regulating how that might accumulate
across the entire diet, which I think is a very important point.
In my mind, if I were going to design a vision for where our food
supply risk level ought to be set, I would say a 10 to the minus 6th
standard over the entire diet. Now, obviously, I'm surprised toma-
toes are not hitting me in the back of the head, but in my view, no
one is interested in having an increased incidence of cancer risk
from a pesticide in the diet.
I teach 250-300 students per year, so say over the last decade I
have taught several thousand students, and I teach pesticide regu-
lation, and I teach exposure modelling, and I have consistently
asked those students whether or not they are willing to assume an
increase in cancer risk. And they don't want to if they have an
option, particularly if it is a no-cost option.
So the basic question is this: How much cancer risk should the
U.S. population bear without its consent? And this is a very deli-
cate issue since one group is reaping the benefits while the entire
population is bearing the risks. And the question here today that
we are confronting directly is are children bearing a higher risk
than we think is reasonable.
EPA will tell you that these are technical matters and that they
should be handled administratively. My argument to you is that
these are not technical matters. The establishment of a risk stand-
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ard at 10 to the minus 6th by food, by the diet, or by chemical is
inherently a political issue. It is something that I think this com-
mittee is well-positioned to take on.
Let me apprise you of several recent findings that you have in
charts behind you. If you look at the dietary differences, you find
in Chart 1-again, let me just refresh your memory-children are
consuming more as 1 year-olds than they are as 5 year-olds, and by
the time they approach the age of 20 they are consuming a much
lower level of apple juice. If I put up a chart of orange juice, peach-
es, pears, the chart would look quite similar.
If you then factor in residue data, actual market basket residue
data as well as cancer potency factors, to develop a risk estimate,
you have the results in Chart 2, the middle chart. What I have
done here is simply to annualize the risk so that the risk is being
presented year by year.
The message here from the middle chart is that kids are accumu-
lating risk at a more rapid rate than one would assume if one
looked at the U.S. average level. The U.S. average amount of risk
is demonstrated on the far right-hand side of the middle chart.
The far right chart demonstrates the proportion of lifetime risk
that is accumulated in different age periods. Again, the "x" axis is
simply ages. So that you see for 1 year-olds, they had been accumu-
lating according to EPA's estimates approximately 36 percent of
lifetime cancer risk while aJar was permitted for use. And my un-
derstanding is that its tolerances have now been completely can-
celed as of May 31, 1991. So this is not a problem today, and I am
choosing this example because this is an example that the National
Academy of Sciences is not choosing, but it demonstrates very
clearly that a 10 to the minus 6th risk can be accumulated for one
chemical on one food for 1 year in life, and that this rate of accu-
mulation is something that needs to be regulated. And I think that
the standard that has been proposed in your legislation of allowing
a 10 to the minus 6th risk per chemical, but not permitting its rate
of accumulation for any age class, ages one to 5, to exceed 10 to the
minus 6th divided by 70 would be a very protective device.
Let me briefly conclude my testimony by saying that what is
clearly at stake here is the credibility of the entire regulatory
system. We had the merits of using alar being debated on the Phil
Donahue show and on "60 Minutes" rather than within EPA hear-
ing rooms. This demonstrates to me system failure.
Loss of public trust in regulators charged with protecting our
food supply is a very dangerous situation, and it is my belief that a
clear, protective health-based standard such as the one that you
have proposed would restore that public trust.
Thank you very much.
[The prepared statement of Mr. Wargo follows:]
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Prepared Statement of Mr. Wargo
I. INTRODUCTION
Thank you Senator Kennedy. I am honored to appear before you today to discuss
the merits of proposed changes to the PIFRA and FPDCA. As you are aware, I have
spent the pact 7 years researching childhood patterns of food consumption and
associated pesticide exposure, as a basis for evaluating the safety of the nations
food supply. My academic expertise lies in the area of public policy.
Particularly, I etudy how scientific uncertainty is exploited by special interests
in the setting of regulatory policy.
I should also tell you that I have been as critical of environmental and
consumer groups as I have of private corporations in their methods of data analysis
and interpretation of results. My "Opocial interest" is simply the environmental
health of children.
I am appearing here today as a faculty member at Yale University, where I hold
appointments in the School of Forestry and Environmental Studies, the Political
Science Department and where I am Director of Undergraduate Studies for Yale
College's Studies in the Environment Program. My appearance in conditioned by
several important reservations. I have been working with a National Academy of
Sciences Committee on Pesticides in the Diets of Infants and Children, which has
been charged by Congress and EPA with the task of determining if children are
sufficiently protected from potentially harmful exposures to pesticides by current
law. In an ideal world, the committees conclusions and recommendations would be
available for presentation at this hearing. Obviously this is not the case.
The comments I am making today reflect only my own opinions and
interpretations, not those of the NAS Committee. I am not appearing as a
spokesperson for the Committee. Also, I must refrain from divulging findings,
conclusions and recommendations of the Committee, which may make it necessary for me
to decline to respond to certain specific cpiestione. It I sense a conflict and
declino to respond, please understand that it is my respect for scientific process
including full and fair peer review of the Committee analyses which is the cause.
It is my understanding from conversations with your staff that euch a response would
be acceptable.
Also, all of the data which I am presenting ia available to the public. The
food consumption data has been available now for nearly 13 years.
I have been a student of pesticide policy for eight years, having taught both
undergraduate and graduate courses in pesticide regulation and computer modelling at
Yale and before that at Dartmouth college.. My knowledge of childhood patterns of
food consumption, and the implications for pesticide exposure and regulation,
predates the NAS Coimaittcb'e formation by at least five years.
1
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II. AGE RELATED VARIANCE IN FOOD CONSUMPTION
If one looks at Table B~2 on page 192 of the Delaney Paradox study published
by the National Academy Press, you will find a table prepared by me in 1987
demonstrating differences in patterns of food consumption if childhood and us
average intake are compared. There is an interesting footnote to that table, which
suggests one reason why we are all here today. It reads:
"Differences in mean consumption estimates among subpopulations will result in
differences in chemical intake estimates."
Only a brief acquaintance with food consumption data sate makes it obvious
that consumption patterns vary significantly with age, region of the country,
ethnicity and income levels. The idea that there is a stable pattern of food
consumption which would permit the estimation of risk across 70 years is patently
ridiculous.
The following tables summarize ag. related variance in patterns of food
consumption derived from the 1977-78 National Food Consumption Survey. These data
were published by me along with Daniel Krewaki, Chief of Biostatistics at Health and
Welfare, Canada and Robert Rizek, of the Human Nutrition and Information Service,
USDA.
Two different research strategies were then employed. First, for each age
class, the data were arrayed from molt consumed to least consumed food, by
percentage of the total diet. The consumption estimate for each age class and food
type was then compared to the entire sample to estimate a multiple of U.S. average
consumption, again for each food. These data are arrayed in the tables which appear
at the end of this article. Significant findings for each age class are described
briefly below.
TABX.U 1
FOODS REPRESENTING GREATER THAN 1% 0? US AVERAGE DIET (77-78)
AND AGE CLASS CONSUMING BIGREST MULTIPLE AHOVE US AVERAGE CONSUMPTION
PAGENO="0015"
11
AGE CLASS MULTIPLE
OP US AVG
HIGHEST MULTIPLE CONSUMPTION
TABLE 2
NURSING INFANTS
FOODS CONSTITUTING UXOREST PERCENTAGES OF DIET
1977-1978
COMMODITY
% US AVG
DIET
CONSUMING
OP US AVERAGE
1
WHEAT-FLOUR
0.074
CHILDREN 1-6
2.25
2
BEEF-LEAN
0.069
CHILDREN 1-6
1.82
3
ORANGES-JUIC
0.067
CHILDREN 1-6
3.08
4
MILK-NON-FAT
0.054
NON-NURSING INFANTS
7.33
S
POTATO(WH)-P
0.047
CHILDREN 1-6
2.14
6
CANE SUGAR
0.044
CHILDREN 1-6
2.49
7
EGGS-WHOLE
0.033
CHILDREN 1-6
2.30
8
TOMATOES-WHO
0.029
CHILDREN 1-6
1.68
9
APPLES-FRESH
0.028
NON-NURSING INFANTS
6.91
10
MILK-FAT SOL
0.025
NON-NURSING INFANTS
3.62
11
PORK-LEAN
0.023
CHILDREN 1-6
1.84
12
CHICKEN+SKIN
0.023
CHILDREN 1-6
2.15
13
BEEF-FAT
0.022
CHILDREN 1-6
1.81
14
POTATO(WH)-W
0.021
CHILDREN 1-6
1.79
15
BEET SUGAR
0.019
CHILDREN 1-6
2.49
16
SOYBEANS-OIL
0.019
NON-HORSING INFANTS
4.55
17
APPLES-JUICE
0.014
NON-NURSING INFANTS
16.65
18
CORN,SWEET
0.014
CHILDREN 1-6
2.39
19
BANANAS-FRES
0.014
NON-NURSING INFANTS
4.96
20
PEACHES-FRES
0.013
NON-NURSING INFANTS
10.50
21
LETTUCE-HEAD
0.013
NURSING FEM 13+
1.57
22
PORK-FAT
0.012
CHILDREN 1-6
2.10
23
BEANS-SUCC-G
0.012
NON-NURSING INFANTS
4.V~5
24
FISH,FIN-SAL
0.011
NURSING FEM 13+
2.41
25
PEAS 50CC-GA
0.010
NON-NURSING INFANTS
3.72
26
CARROTS
0.010
HON-NURSING INFANTS
9.05
27
TOMATOES-PUR
0.010
CHILDREN 1-6
2.15
28
CORN,GRAIN-E
0.010
HISPANICS
3.37
29
RICE-MILLED
0.010
NON-HORSING INFANTS
8.69
PAGENO="0016"
12
(n109)
FOOD TYPE % DIET MULTIPLE OF
US AVERAGE
1 APPLES-JUICE 0.119 14.9
2 APPLES-FRESH 0.097 6.3
3 ORANGES-JUICE 0.063 1.7
4 PEARS-FRESH 0.061 i4.4
S MILK-NON-FAT SOL 0.059 2.0
6 PEACHES-FRESH 0.057 7.7
7 CARROTS 0.046 7.9
S BEEF-LEAN 0.043 1.1
9 MILK SUG (LACT) 0.039 27.9
10 BANANAS-FRESH 0.037 4.8
11 RICE-MILLED 0.025 4.7
12 PEAS SUCC-GABDEN 0.018 3.1
13 BEANS-SUCC-GREEN 0.018 2.6
14 OATS 0.016 5.9
15 SOYBEANS-OIL 0.015 1.5
TABLE 3
NON-NURSING INFANTS
FOODS CONSTITUTING MORE TERN 1% 0? AVERAGE DIET
FOOD TYPE % DIET MULTIPLE OF
US AVERAGE
1 MILK-NON-FAT SOLIDS 0.123 7.3
2 APPLES-JUICE 0.075 16.7
3 MILK SOS (LACT) 0.063 79.1
4 APPLES-FRESH 0.060 6.9
5 ORANGES-JUICE 0.059 2.9
6 PEACHES-FRESH 0.044 10.6
7 PEARS-FRESH 0.036 15.0
B CARROTS 0.029 9.1
9 MILK-FAT SOLIDS 0.029 3.6
10 BEEF-LEAN 0.028 1.3
11 SOYBEANS-OIL 0.027 4.6
12 RICE-MILLED 0.027 8.7
13 COCONUT-OIL 0.025 49.8
14 BANANAS-FRESH 0.021 5.0
15 WHEAT FLOUR 0.018 .8
4
PAGENO="0017"
13
TABLE 4
CHILDREN 1-6
(i1.3,663)
FOODS CONSITITUTING TEE HIGHEST PERCENTAGE OF DIET
AND MULTIPLE ABOVE US AVERAGE CONSU?4PTION ESTIMATE
FOOD TYPE % DIET MULTIPLE OF
US AVERAGE
1 ORANGES-JuicE 0.091 3.1
2 WHEAT-FLOUR 0.074 2.3
3 MILK-NON-FAT SOLIDS 0.072 3.0
4 BEEF-LEAN 0.056 1.8
5 CANE SUGAR 0.048 2.5
6 POTATO(WN)-pULp 0.045 2.1
7 APPLES-FRESH 0.035 2.8
8 EGGS-WHOLE 0.034 2.3
9 MILK-FAT SOLIDS 0.032 2.8
10 APPLES-JUICE 0.030 4.8
11 CHICKEN+$2CIN 0.022 2.2
12 TOMATOES-WHOLE 0.022 1.7
13 BEET SUGAR 0.022 2.5
14 BANANAS-FRESH 0.020 3.3
15 PORK-LEAN 0.019 1.8
TABLE 5
CEILDREN 7-12
FOOD CONSUMPTION BY PERCENT OF AVERAGE DIET 1977-78
FOOD TYPE % DIET MULTIPLE OF
US AVERAGE
1 WHEAT-FLOUR 0.085 1.7
2 ORANGES-JUICE 0.072 1.6
3 BEEF-LEAN 0.067 1.4
4 MILK-NON-FAT SOL 0.066 1.8
5 POTATO(WH)-PULP 0.052 1.6
6 CANE SUGAR 0.052 1.7
7 APPLES-FRESH 0.032 1.7
8 MILK-FAT SOLIDS 0.031 1.8
9 EGGS-WHOLE 0.028 1.2
10 TOMATOES-WHOLE 0.026 1.3
11 BEET SUGAR - 0.023 1.7
12 CHICKEN+SKIN 0.021 1.4
13 BEEF-FAT 0.021 1.4
14 PORE-LEAN 0.020 1.3
15 SOYBEANS-OIL 0.019 1.5
PAGENO="0018"
% DIET MULTIPLE OF
US AVERAGE
TABLE 7
ADULTSX 20 YEARS AND OLDER
FOOD CONSUMPTION BY PERCENT OF AVERAGE DIET 1977-78
% DIET MULTIPLE OF
US AVERAGE
14
TABLE 6
TEENAGERS AGES 13-19
FOOD CONSUMPTION BY PERCENT OF AVERAGE DIET 1977-7B
FOOD TYPE
WHEAT-FLOUR
0.086
1.07
BEEF-LEAN
0.077
1.03
ORANGES-JUICE
0.063
0.07
POTATO(WH)-PULP
MILK-NON-FATSOL
0.057
0.056
1.10
0.97
CANE SUGAR
0.052
1.10
EGGS-WHOLE
0.031
0.87
TOMATOES-WHOLE
0.030
0.96
NILK-FPiTSOLIDS
0.028
1.01
PORK-LEAN
0.025
1.01
BEEF-FAT
0.024
1.04
APPLES-FRESH
0.024
0.79
CNICKEN+SKIN
0.024
0.95
BEETSUGAR
0.023
1.10
POTATO(WH)-WHOLE
0.020
0.92
FOOD TYPE
BEEF LEAN
0.076
0.83
WHEAT-FLOUR
0.070
0.71
ORANGES-JUICE
0.055
0.61
POTATO(WH)-PULP
0.047
0.74
CANE SUGAR
0.037
0.64
EGGS-WHOLE
0.037
0.83
TOMATOES-WHOLE
0.034
0.88
MILK-NOH-FATSOL
0.033
0.47
PORK-LEAN
0.027
0.87
POTATO(WH)-WHOLE
0.025
0.90
BEEF-FAT
0.024
0.83
CHICKEN+SKIN
0.024
0.79
APPLES-FRESE
0.021
0.58
MILK-PATSOLI0S
0.019
0.57
SOYBEANS-OIL
0.019
0.75
PAGENO="0019"
15
since EPA currently is using the 1977-78 NFCII data as a basic for
exposure and risk assessment I initially explored variance among the age classes
which they employ. This survey has numerous deficiencies including its age, the
fact that it was conducted only over one three-day period, and the small sample size
of the nursing infant age class. Perhaps the most important limitation is the fact
that the survey ref lects consumption patterns for only a single alice in time, while
it is likely that dietary patterns change with considerable speed. Also, there is
little reason to believe that one three-day period is an accurate reflection of
either long-term consumption patterns which might be used for chronic exposure and
risk assessment, or short-term single-day high consumption levels which might be
used for acute exposure and risk assessment. Still, this survey constitutes the
most comprehensive data set currently available to compare all age classes in our
population.
Individual consumption reports were broken into 376 different types of foods
and 691 forms of those foods. Average consumption was calculated for 376 different
types of food, and for 22 different population subgroups, and then aggregated into
five age classes including non-nursing infants, children 1-6, children, 7-12,
teenagers and adults over 20. Food consumption patterns have also been aggregated
yearly between the ages of birth and 20, however the aggregation just described was
performed to make comparisons possible between these anslyeos and analyses commonly
performed by EPA using their tolerance assessment process.
Twenty-two foods constitute more than 1% of the average non-nursing infant's
diet. Six of these are fruits which together account for 29% of the diet while nine
foode are fruits or vegetables making up 37% of the diet. Soy and coconut oil
together account for 5.2% of th. diet, most likely from infant formulae. Non-
nureing infant consumption of soy oil is 4.6 times higher than the 13.6. average
level, while coconut consumption is 50 times the U.S. average, a fact which could
have significant implications for the regulation of fat solublo pesticides. Milk
products consititute 21.5% of the average non-nursing inf ante diet, 7.3 times the
U.S. average for non-fat milk solids intake and 3.6 times the U.S. average for fat
milk solids. Of the 376 foods surveyed, only 148 were positively reported am
consumed for non-nursing infants while 375 were reported for the entire 30,770
person sample, indicating a relatively low level of dietary diversity. Those data
immediately suggest the importance of monitoring both the percentage of total diet
and the multiple of the U.S. average consumption level as critical indicators of
concern for estimating dietary exposure to pesticides. It is important to recall
that for the overwhelming majority of tolerances currently in effect, exposure and
risk estimates related to tolerance are founded upon U.S. moan food consumption
levels by food type.
Children between the ages of 1 and 6 consume 26 different foods which
individually account for mor. than 1% of their diet. Seven of these are fruits or
fruit juices totalling 21% of the diet. For once it may be appropriate to compare
apples end oranges since together they constitute 16% of the diet. Dietary
diversity has increased in this age class through the inc'easod dominance of wheat,
beef, sugar, eggs and chicken and increased variety of vegetable consumption. The
number of foods consumed above the U.S. average level has declined, as have the
magnitudes of the multiples above average levels. Thie is likely a response to two
variables: first, a rapid increase in dietary diversity after the age of 1, and
second, a diminishing effect of the bodyweight conversion factor es average
childhood weights approach average adult weightri.
7
PAGENO="0020"
16
Children between the ages of 7 and 12 have even a greater level of dietary
diversity and diminishing dominance of any single food. Wheat flour, beef, and
potatoes constitute a higher percentage of the diet, while orange juice and apple
products have fallen, though only slightly. The 15 most consumed foods for children
1-6 and those 7-12 are almost identical, although the relative rankings differ
slightly. The average intake for children 7-12 approaches the U.S. average intake.
For teenagers (13-19 years old) wheat flour, beef, potatoes and eggs, continue
their ascendance in relative importance over fruits and vegetables with the
exceptions of orange juice (which is still among the three most consumed foods, and
tomatose. Again, dietary diversity expands with age while the consumption
estimates, when expressed as multiples above U.S. average levels, continue to
decline with age. Also, for the first time, 7 of the top 10 foods are consumed at a
1ev~l lees than the U.S. average.
Adult food consumption patterns reflect a continuation of the trends noted
above. Beef becomes the most consumed food, while intake of wheat flour, orange
juice, potatos and milk decline slightly from teenage levels. The list of the 15
most consumed £ood~ is almost identical for both teenagers and adults; and diversity
of foods increases again with age, although this may be the result of the large
adult sample size. Similarly, the level of adult food intake is extremely close to
the U.S. average estimate.
A closer examination of the consumption patterne of children Lees than 12
years of age reveals that for each of the 15 most consumed foods, childhood intake
is higher than adult intake end U.S. average intake, demonstrated by Table 1. This
finding raises a serious question cencarning the selection of the most appropriate
food consumption level to use as m basis for estimating pesticide exposure. Choice
of the U.S. average consumption lmvel may dramatically underestimate food
consumption and associated pesticide exposure for children.
Nearly 45% of nursing infantadiet is composed of fruit products. Six of the
ten most consumed foods are fruits constituting 43% of the average diet. Nursing
infants consume over five times the U.S. average consumption level for 22 different
commodities. Half of these foods are either fruits or vegetables which collectively
represent over 44% of the average nursing infant diet.
III. RESIDUE DATA
Similarly, there is tremendous variance among sources of residue data: field
trial, warehouse, marketbaskot, domestic, import, compliance and surveillance
residue surveys are likely to yield quite variable results. This variance is often
significant within a year, let alone across a 70 year period, chemical use patterns
may also vary substantially from one year to the next, and from one region of the
country to another, making the projection of a 70 year pattern of exposure and
associated risk equally absurd.
8
PAGENO="0021"
17
IV. RISI( ESTIMATION
TO understand the reasonableness of various risk standards, one needs briefly
to consider how risks are calculated. This is a very simple piece of algebra. The
amount of food consumed is multiplied by the expected residue value and the product
is an exposure estimate. Thus if you ate one kilogram of apples (obviously an
exaggeration), and there was 1 mg of chemical X per kilogram of apples (1 ppm) then
your exposure would be the product, or 1 mg of chemical X. This exposure would then
be adjusted based upon your bodyweight and expressed as ~ mg/kg bw/day.
The resulting exposure, adjusted by safety factàre, may then be compared with
acceptable daily intake levels derived from toxicity studies or it may be translated
into an estimate of cancer risk. The cancer risk estimate is derived by multiplying
the exposure by a "cancer potency factor" which is simply an estimate of the
expected number of tumors associated with any given exposure. So if one knows the
exposure to Chemical X, and the cancer potency of Chemical X, then one can multiply
the two to yield an estimate of expected cancer risk.
V. NEGLIGIBLE RISK STANDARD
The tradition in cancer risk assessment has been to presume consistent
exposure across a lifetime to yield a lifetime risk estimate. This estimate is
commonly expressed as "one tumor in one million people exposed at dose x over 70
years, or an average lifetime." Not only does this approach assume consistency in
food consumption, but also consistency in chemical residue levels on the dinner
plate.
In the area of cancer risk assessment, the level of complexity is similarly
enormous. Variance in risk estimates may be due to differences in physiological
susceptibility, food consumption patterns, residue levels in food, and variance in
toxicity studies.
The appropriate public policy response to this variance seems quite simple.
1. use the best available data.
2. Characterize the uncertainty in the data accurately.
3. Characterize the variance in exposure and risk among
groups which arc physiologically most sensitive to the
toxins.
4. Choose a time horizon that the data supports.
5. Establish a standard which overprotscts.
For all of those reasons, the ].06/70 annual risk ceiling seems reasonable.
The standard would allow an individual to accumulate a 1/1,000,000 risk over 70
years, however, it governs the RATE OF ACCDMtJLATION, ensuring that riok is not built
up more rapidly during critical childhood years.
I havo a colleague here at Yale, Charles Lindblom, who is femoue in part due
to him articulation of a theory of dscioionmaking now known as "disjointed
incramontaliem". The tolerance~setting process is both disjointed and incremental.
While there are some 320 pesticides allowed for use on food (along with 1200 inert
ingrediente), EPA considers only one chemical at a time.
9
PAGENO="0022"
18
Please recall that the 106/70 risk standard in this bill applies only to a
single chemical, despite the existence of 319 other chsmical~ which the A~ency
allows to exist as residues in our nations food supply. In 1987 during the
preparation of the Delaney Paradox report, the NAS Committee found it necessary to
limit their review to only 28 chemicals which were then classified by EPA as either
possible or probable cancer inducing compounds. EPA has published a more recent
list of suspected carcinogenic pesticides which includes 75 compounds. Clearly, as
toxicity testing protocols become more stringent, more compounds are being tested,
yielding positive oncogenic results. Also, advances in residue detection technology
is allowing us to find residues where, using older methods, we thought they did not
exist. It is my opinion that thie trend is likely to continue.
For the sake of simplicity, let us assume that within the next 5 years we all
agree that 70 of the 320 compounds are found to be oncogenic, and therefore require
the application of the l06/70 standard. Thu means that a simple the standard we
are considering today would allow the accumulation of io(6, risk per year, per
individual, or 70 times 10 6 risk over a lifetime (7 * 10 ~)). This would be an
average level
VI. CONCLUSION
The negligible risk standard proposed within this bill would offer substantial
additional protection to children. By contrast, choosing a aimply one in one
million risk standard per chemical fails to regulate the rate of accumulation of
risk, essentially allowing a "front-end loading" of risk during childhood. Also,
the a simple one in one million risk standard neglects the fact that there are over
300 food use chemicals permitted to exist as residues on foods, and as many as 25%
of these may be oncogenic. Total dietary risk from all oncog.nic compounds could
easily exceed 1 in 100,000, perhaps even 1 in 10,000. Thie concludes my testimony
and I would happy to entertain questions.
10
PAGENO="0023"
19
CONSUMPTION (G/KGBW/DAY)
z
(N
-a~
>
-~
:7
(..` z
H8 .
LU -
(f)~
z~
LL~ __
-~-~
~88888~~
0 __________ -
PAGENO="0024"
3c
(flr
0r9
190
I~3
CFIILDFIOOD PATTERNS OF RISK ACCU MULATIION
77-78 MEAN CONSUMPTION DA1A
1.5
1 .4
1.3
1.2
1.1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
2
4
6 8 10 12 14
ACE CLASS
APPLE JUICE (UDMH)
16 18 20
PAGENO="0025"
PROPOIRTION OF LiFE~I~IME ACCUMU LATF~D HISK
0.4 - _________
0.35
0.3
0
11
0
0.25
0
z
0
0.2 -9
-9
19
H
0.15
19
(~/1
0.1
0.05
0
BY AGE CLASS: 77-78 MEAN CONSUMPTION
2 4
6-10
AGE CLASS
~ APPLE JUICE (uDMH)
16-20
61-70
51-60
PAGENO="0026"
22
The CHAIRMAN. Thank you.
Dr. Jackson.
Dr. JACKSON. Good morning, and thank you, Senator.
I am Dr. Richard Jackson. I am a pediatrician with expertise in
epidemiology, toxicology and public health. I am chairman of the
American Academy of Pediatrics committee on environmental haz-
ards. I am also president of the Association of State and Territorial
Health Risk Assessors, an affiliate of the State health officials or-
ganization. I am also branch chief for the California Department of
Health Services, dealing with risk assessment for air, water, pesti-
cides, food and Proposition 65.
But today I am speaking on behalf of the American Academy of
Pediatrics. I am also privileged to serve on the same National
Academy of Sciences committee that Dr. John Wargo is, and noth-
ing in my statement should be construed as reflecting the opinions
of that National Academy of Sciences committee or of the Academy
of Sciences. Those deliberations are obviously confidential.
The thrust of my testimony today is that while the food supply
appears to be generally safe, the legal allowable limits for pesticide
residues in food, the tolerances, do not always reflect safe levels for
everyone, especially children.
Because of the large amount of food and drink, the increased ca-
loric intake, the increased fluid intake, the increased oxygen use by
children that Dr. Wargo has talked about, and because kids are
more sensitive to certain toxicants than are adults, if we protect
kids we are going to protect all consumers.
There was an interesting episode last year in Michigan where a
chemical, mercury, has been used for years in paint. It was used to
keep fungus down in paint. A child was discovered to have a dis-
ease called acrodynia, which is where the face, the tongue, the
hands and the feet turn red, and the skin starts peeling, and it
turned out to be due to the mercury in this paint.
The point of this is that it wasn't an adult, it wasn't the painters
that showed up as the most sensitive organism or the sentinel
event. It was a child. And if we are protecting kids, we are going to
protect everyone, and that's one of the points I want to make here.
I have some secondary points that I want to discuss for just a
minute, and then I'll come back to the main point about tolerances.
One point is that acute toxicants, things that make someone sick
right away-the aldicarbs, the Guthions, the Phosdrins, the chemi-
cals that were found in the potatoes and the bananas-need to be
scrutinized much more than they have been up until now.
Senator Simon talked about going into the migrant camps, and
clearly-I have investigated a lot of farm worker poisonings-it is
the acute chemicals, the people who go into the field and begin
vomiting right away. These are the same chemicals that I don't
think are really being looked at adequately in terms of food resi-
dues, and I think we could take care of both workers and the
public at the same time by scrutinizing these chemicals more.
I think also that the folks who are regulating these acute chemi-
cals tend to look at them one at a time, and yet some of you will go
home, and your home has been treated for termites with a chemi-
cal called chlorpyrifos, or Dursban, which slowly breaks down and
can get into the home environment. If you go into the local cafete-
PAGENO="0027"
23
na-and I'm sure the chef's kitchen downstairs-the floor has been
sprayed with this same chemical to control roaches. If your home
happens to have fleas, and someone sets off a flea bomb in that
home, and it filters down onto the rug, and you have a baby that is
crawling around or rolling around on the floor, it is that same
chemical chlorpyrifos.
If you have your lawn treated with various pesticides, chemicals
of the same chemical category are used in that lawn treatment.
And by looking at each chemical individually and not looking at
the overall impact of these chemicals, we are not serving children
very well. So I'd like to see much more scrutiny of these chemicals
as a group, particularly because a lot of them operate through the
same chemical pathways or same human health pathways.
Now I am going to come back to my main point, because this is a
point that is required already in law. The Federal Food, Drug and
Cosmetic Act requires that the tolerances, the legal limits for pesti-
cides in food, be health-protective. And I think they should be
health-protective. They ought to be health-protective for adults, for
children, for vegetarians, for ethnic minorities. I mean, what's the
purpose of having a legal limit if it is not protective?
In fact, we recommend as public health authorities that people at
lots of fruits and vegetables and grains. If they do that, if their
doctor tells them to eat lots of bananas because you are on diure-
tics for your heart disease, it ought to be safe for the elderly person
who is being told to eat bananas, or the baby who is being told to
eat your broccoli.
I indicated that the Federal Food, Drug and Cosmetic Act re-
quirement that these allowable limits be safe is being disregarded.
Let me give you an example.
There was a flap recently about aldicarb. This is a chemical that
inhibits an enzyme in the body and causes salivation and diarrhea
and other acute illness symptoms. Aldicarb is allowed on bananas
at .3, three-tenths of a part per million. If a 17-pound baby eats one
banana at the legal allowable limit, they are getting 30 times the
acceptable daily intake of this chemical. They are getting about 6
micrograms per kilogram, and that is about the level that we
began to see symptoms in the great watermelon outbreak in Cali-
fornia. It is about one-tenth the level that we saw someone almost
die in the aldicarb episode in California.
So there is clearly not an adequate margin of safety for some of
these chemicals, especially for kids.
Now, you are going to hear a lot of arguments about why these
legal limits should not be safe. One argument is that, well, there is
lots of testing. We have these fancy datasets that tell us that the
actual residues in food are much lower than the legal limits. As
someone pointed out, it is sort of like saying that the speed limit is
350 miles an hour, but everything is fine because most people only
drive 100 miles an hour.
I would argue that if you really sit down and scrutinize the sys-
tems where they actually sample food and look at the pesticides in
food, that no one really knows what the actual residues in food are.
A chemical like aldicarb, the most seriously toxic chemical that is
sold, was used for a dozen years before it was discovered that hot
potatoes, toxic potatoes, could get into a child's diet. It was used for
PAGENO="0028"
24
a dozen years before it was discovered that toxic bananas could get
into a child's diet.
So telling me that everything is safe because it meets tolerances
is very cold reassurance.
The other argument you are going to hear is that, look, these
chemicals have been used for years, and where are the bodies. We
don't see anyone really being proven as sick from pesticides. I
heard this over the aldicarb and bananas argument.
We investigated a case in 1988 where two people ate taquitos, a
snack food, in Orange County, and within a few minutes the stepfa-
ther and son developed generalized seizures, grand mal convul-
sions, and had to be taken away by ambulance to a hospital. They
were put on anticonvuisant drugs. The uncle lost his driver's li-
cense. It was discovered to be due to a chemical, the illegal use of
endrin, someone had contaminated the food with endrin, an insecti-
cide.
When we heard about that, we did a followback, public notifica-
tion in that county, several months later, and we discovered three
more people who had had to be carried by ambulance to a hospital,
had to be treated for generalized seizures, who had lost or were in
the process of losing their driver's licenses, and they had never
been discovered.
Now, imagine with an illness episode of that severity, when they
go undetected, not picked up, what happens when a pediatrician
sees a baby with a little too much diarrhea or a little tearing or a
little too much urination. Who would think of sending off a banana
for a $500 pesticide analysis? It really just doesn't happen. So you
don't have a reasonable system to track down acute illness epi-
sodes, and anyone who tells you that the fact that we don't have
bodies means everything is fine, I think they are basically dissem-
bling to you.
In the case of aldicarb in bananas and in potatoes, where we
found these individual food samples-and some of them high
enough to be within one-tenth of the level that would be lethal-
my assessment is over the last dozen years or so that Americans
have been becoming ill from residues in food, and it was just too
difficult to pick these up, but in fact, illness has been occurring.
I have some other arguments that I can go through about why
things ought to be fixed; they are in my written testimony, and you
can look at it yourselves.
I think the point of aldicarb in bananas shows that out-of-date
and nonprotective tolerances hurt everyone. They hurt the public,
of course. They also hurt chemical companies that are seeking to
get licensed new and safer products, and they also hurt farmers
who are growing food in the belief that they are doing the best
they can and adhering to the law and then finding out that the
food they are producing has no safety margin, and they run the
risk of the loss of public acceptance.
In situations where it can be shown-I have heard arguments-
in fact, I read the former surgeon general's testimony that there
have been great health benefits from having cheap food because of
pesticides. I am not sure how much cheaper food is actually be-
cause of pesticides. And clearly, if there are health-health trade-
offs that need to be made-and by that I mean if you can show
PAGENO="0029"
25
that there are health benefits from the use of various chemicals,
then I think we ought to make these trade-offs.
In the area of chlorination of drinking water, we chlorinate
water in order to prevent typhoid, and we know that that leaves a
long-term cancer risk, a low but long-term cancer risk. And that
trade-off is made explicitly in the public record. Everyone is aware
that this trade-off is made. And I'd like to see the same set of
trade-offs made publicly for pesticides in food.
I think in summary the point I'd like to make and leave you
with is that the regulatory limit on food, the pesticide food toler-
ance, should be the tool for health protection.
I thank you very much for your interest in the protection of chil-
dren and for allowing me to testify.
[The prepared statement of Dr. Jackson follows:]
PAGENO="0030"
26
1
Prepared Statement of Dr. Jackson
Good Morning, 1 am Dr. Richard J. Jackson. I am a pediatrician with
espertise in epidemiology toxicology and public health. I sin Chairman of the
American Academy of Pediatrics (AAP) Committc,c, on Environmental Hazards,
president of the Association of State and Territorial health Risk Assessors
(ASTHRA), and head of the Risk Assessment Branch for the California Department
of Health Services. Today 1 am Speaking on behalf of American Academy of
Pediatrics (AAP). I am also privileged to serve on the National Academy of
Sciences (NAS) Committee that is working on issues related to this hearing,
but- those deliberations are confidential, and my testimony should not be
construed as reflecting the opinions of the committee or of the NAS.
The American Academy of Pediatrics is an organization of 40,000
pediatricians dedicated to the well-being of children. The Academy has had a
Icng standing and core membership interest in the issue of children's diets,
aid concern about toxicologic hazards to children.
The main points of my testimony today are that while the food supply
appears to be generally safe, the legal allowable limits for pesticide
residues in food the pesticide, do not always reflect safe levels for
everyone, especially children. Because of the large amount of food and drink
that children consume relative to body weight, because they consume a limited
variety of foods, and because of their increased sensitivity at certain
developmental stages, if pesticide tolerances are sale for children,
tolerances will then be safe for all consumers.
Children drink more fluids, consume more calories, eat more of certain
fc,ods, especially milk, soy, and fruit, thati do adults. They are more
sensitive to certain pesticides than are adults. For example, last year a
child was found with the acrodynia, a scriouc i]lnese related to mercury
toxicity that resulted from the fungicidal compound. phenyl mercuric acetate,
(PHA) in indoor latex paints. The greater sensitivity of the developing human
PAGENO="0031"
27
2
brain to lead or mercury, or the developing bone marrow to radiation are
further examples of the sensitivity of the growing child.
Some secondary and specific points which I will mention but will not
discuss further in my testimony arc:
that acute toxicants used on foods require more scrutiny. The
experiences with aldicarb in potatoes and bananas are forewarnings that we
should pay attention to acutely toxic pesticides, at least as much as we are
concerned about long term effects.
that those agencies deciding allowable- levels in food should assure
that some margin of safety be provided for non-food exposures to these same
chemicals. For example, ch]o~p~rifosis used extensively on food, but it is
also used throughout a child's environment: as a terrniticide, as a flea bomb,
a roach spray, and as a lawn pest treatment. when we decide acceptable
levels for chemicals in drinking water, we always assume exposure by other
routes, especially food, in contrast, acceptable food levels are decided
without consideration of other routes of exposure. and
that chemicals having the same toxicologic effects, such as the
organophosphate and carbamate pesticides, should be regulated as a group, and
not o:~ly as individual and unrelated compounds. For example, chlorpyrifos,
the pesticide I mentioned above, shares its toxic pathway, cholinesterase
inhibition, with many other pesticides used on food and in the home.
I now return to my main point. It would seem self-evident, in fact, it
i~ already required under kood and Drug law, but not adhered to. Legal
allowable limits for pesticide residues in food, the pesticide tolerances,
should he safe, that is, they should afford an adequate margin of safety for
any consumer, adult, child, vegetarian or ethnic minority.
Discs rich in fruits, grains, and vegetables are the very diets that we
health authorities recommend (.0 the public. Clearly, the highest amount of
pesticide residue legally permitted in food should be a level that would allow
a child to consume apples or poaches ad libiturn, or an elderly person on
medication to consume bananas or bran as needed, or a vegetarian to consume
lcgumes and grains, as required.
I indicated that the Federal Food Drug and Cosmetic Act requiring that
allowable limits be safe is being disregarded. For example, with the example
of sldicarb sulfoxide in banaxias, a 17 pound child (7.6 kg) eating one banana
at the legal allowable limit of 0.3 ppm would be getting a dose of 6 mcg per
kg, 30 times the Acceptable Daily Intake or reference dose for aldicarb
suifoxide. As we learned from the aldicar'b in watermelons outbreak in
California, this was the range where symptoms such as nausea and diarrhea
PAGENO="0032"
28
3
appeared. In that outbreak the most severely ii] person was one woman who
nearly died from eating 56 mcg per kg of aldicarb.
Opponents to these reforms offer the following excuses for why the legal
limits do not have to reflect safety; let us examine these arguments:
Argument 1. Extensive, residue food sampling shows that actual residues are
far lower then the legal tolerances, therefore the tolerances need not reflect
safe limits.
Response 3. The problems with this argument are that no-one truly knows
what the actual residues are. Aldicarb Was u~ett for years on potatoes and
bananas before any sampling of individual food items was performed and it was
discovered that residues could he very high in individual bananas or potatoes
as people actually ate them, rather than as the average of a boxcar load, the
more likely sampling routine.
Residue testing is generally used as a regulatory compliance tool and is
not, intended to adequately profile actual residues. It is generally not
timely or extensive enough to be a true consumer protection tool. It works to
signal pesticide users that if they misuse, they might get caught, and to
protect those who use the pesticide properly.
There is extensive testing of food by FDA, USDA, the States, especially
California, and by private Industry.
The problems with much of this sampling are that:
Acutely toxic chemicals are sampled for in food batches, rather than in
individual food items, as the consumer would likely eat them,
the level of sensitivity used to test for the chemicals is often set at,
or within an order of magnitude of, the too-lenient tolerance,
the lab methods are used to scan for some hut not all chemicals used on
that crop, or they scan for chemicals not used with the consequent false
assurance about the pesticides not found,
the results are not collected with background data or reported to any
central repository,
the methods used vary by laboratory and we do not really know what the
ac-called negative results actually mean.
The reality is that no one truly knows what actual residues in food are
in domestically produced food and even less is known about imports.
Argument 2
There is virtually no evidence of human illness from legal residues of
pesticides in foods, therefore there is no iteed for concern.
Response 2
Dramatic episodes, such as 1000 people made ill, and two fetal deaths,
from illegal contamination of watermelons with aldicarb in 1985 in California
are fortunately very rare. On the. other hand, if this contamination had been
PAGENO="0033"
29
4
with a chronic Loxicant potent carcinogen or reproductive toxicant, the human
disease following months or years later would have gone unidentified.
Even in the case of severe acute poisonings, cause and effect is very
dii'ficult to identify. As an example, in 1988 in Orange County there was an
episode of contamination of a snack food called taquitos with the. powerful
insecticide, endrin. Two members of a one family, a stepfather and son who
had eaten these snacks developed generalized convulsions, grand, inal seizures,
end required emergency treatment, The stepfather faced loss of his driver's
license because of a diagnosed seizure disorder. Believing this to be a local
contamination incident, FDA did not notify other local purchasers of the
product. When the California Department of Health Services learned of the
episodes and followed up it, was discovered that 3 other people had also
become 1)1, were facing loss of drivers' licenses end were receiving
anticonvuiscant therapy. if pesticide food poisoning cases as sovere.as
smhu~ance-requiring generalized seizures go unrecognized as pesticide
poisoning, as it did in the later cases, howdo we expect more subtle
symptoms to be identified? How do we expect an elderly woman on heart
medications to identify her diarrhea, muscle twitching, or mood changes as
related to dietary pesticides. How is any pediatrician going to make this
diagnosis in a toddler?
In the cases of aldicarb in bananas and in potatoes, individually
sampled foods were found well over the inadequate and nonprotective tolerance,
a young child consuming the most seriously contaminated foods could receive a
dose within an order of magnituda. (Len times) of the LI)50. My assessment of
these findings is that, in fact, over the years Americans have been becoming
111 from these residues in potatoes and bananas, hut that it was too difficult
to discriminate these symptoms from other causes of headache, nausea,
diarrhea, muscle and mood symptoms.
There is a lack of real post-market illness surveillance. It is very
poor for pesticide worker illnesses, and virtually nonexistent except for the
most obvious and dramatic food related illnesses,
Argument 3
Only a limited portion of a crop will be treated with a specific
pesticide and therefore assuming all foods have the legal allowable ]lmit will
grossly overestimate the population's exposure.
Response 3
This point is well taken, except for a child living in Florida it is
likely that all her green beans will be treated with fungicide: fungicide use
patterns in California or New York are irrelevant to her.
Because pesticide use patterns change so dramatically year-to-year
and place-to-place, the only way to account for the issue of "proportion of
crop treated" is to cap or limit use iii the pesticide permitting procoes, and
this is infeasible.
47-693 0 - 91 - 2
PAGENO="0034"
30
Argument 4
The tolerances for food are actually enforcement. tools to ensure
compliance with the legally required conditions for use of the chemical in
agriculture. They are. not intended as health standards.
Rssponse. 4
Today will you hear that `the food supply is `safe' because 99% of
domestic and 97% of imported food is below tolerance". This argument only
works if the tolerances are set, as required in law, at safe levels.
The reality is that as long as the tolerance is the only regulatory
standard, the only legally enforceable limit, the FD&C Act and the California
Health and Safety Code are correct in requiring these standards represent
safety. As the example of aldicarb in banenas shows, out-of-date and non~
protective tolerances hurt everyone: the public of course, but also companies
socking to register bcttcr replacement chemicals, and farmers who grow food
with pesticides that may leave residues with no safety margin and who run the
risk of loss of public acceptance.
This committee will hear arguments that the proposed reforms are too
extreme, that they will affect. a cheap and abundant supply of food, and that
they will affect minor crop uses.
We have heard these arguments for a long time. The loss of the
carcinogenic food contaminant EDB did not lead to grain shortages or weevil-
filled flour, it led to clean-up of milling operations so that vermin control
was done with hygiene rather than with a worker and consumer-endangering gas.
The cancellation ten years ago of the speristoxic and carcinogenic ground water
contaminant DBCP did not result in the end of California grape or tree fruit
production -- there are still plenty of grapes and oranges; and apples are
still delicious and plentiful and profitable without Alar.
in those situations where it can he shown that a more stringent
pesticide tolerance would endanger rather that improve public health, this
rationale should be presented explicitly and publicly. In the case of
drinking water chlorination, society rightly trades off the risks of
chloroform residues to obtain the benefits of waterborne-disease prevention;
the same should be done with pesticides in food, but openly, not covertly, and
with the health benefits accruing to those who bear the health risks.
On the issue of "minor uses" I suggest that suitable compromise language
can be worked out. There should be some way both to protect our kids and to
save our Kiwi fruit.
In summary, the only regulatory limit on food, the pesticide food
t,,lerance, should the tool of health protection. Protection of crops is
important, but not more important that the protection of our children.
I am grateful for the opportunity to speak to the committee today. I
and the members of the Academy of Pediatrics, commend and support your
interest in the well-being of children.
PAGENO="0035"
31
The CHAIRMAN. We'll follow a 10-minute rule.
Let me ask you this-even if we establish these standards that
both of you refer to, how are we going to be able to really ensure
the safety of children in the general population, when we don't
know how much is being used on various products?
We can develop a standard here that only if "x" amount of any
of these pesticides is used will the product fall into a standard that
we decide is safe. Yet, some may still use more, some may use less.
Doesn't this sort of get into "never-never-land"? How are we going
to deal with those kinds of issues and questions?
Mr. Wargo.
Mr. WARGO. I think my response would be that the standard
should be based upon health criteria. In other words, you would set
the tolerance to be health-protective. And therefore all of the
guidelines of how the chemicals should be used in the field for all
the different crops would be clearly specified by EPA to minimize
the possibility of having residues above that health-protective level.
I think Dr. Jackson's point that the tolerances should be health-
based is a crucial point, and I think that would solve the problem.
The CHAIRMAN. Dr. Jackson, would you agree?
Dr. JACKSON. Absolutely. I mean, why deal with the complicated
issues of what percentage of the crop is treated, or devising an in-
credibly complicated system to do extensive sampling when in fact
just set the legal standards at the health level, and you cut the
Gordian knot.
The CHAIRMAN. That's making the assumption that those stand-
ards are being followed, but that is obviously something that has to
be pursued by a regulatory process.
What is your response to those in EPA who say we're already
providing these kinds of evaluations of children's needs? These
people believe that, basically, all we need to make it work is the
mandate of Congress, and that as such, we must fashion and shape
a process or a system that will be able to take this into account.
Above all, they believe that what we don't need is a lot of micro-
management in terms of establishing these tolerances for the vari-
ous chemicals. How do you respond to them?
Dr. JACKSON. I number one want to commend the EPA leader-
ship. They recently have done a very good job in this area, and I
want to verbalize that, number one. No. 2, since they are already
doing it, what is the problem with this bill? I mean, if this is
simply codifying what is existing practice, then just let it be. And
number three, if they need to relax or seek a different risk assess-
ment number in various situations, give them an explicit trap door
to allow them to do that. But if this is existing practice, then let it
be.
Mr. WARGO. Senator, if I could respond to that.
The CHAIRMAN. Yes.
Mr. WARGO. It is not possible for EPA to be capable right now of
accurately assessing childhood exposure because of the lack of
availability of good residue data as well as recent consumption
data, and also the way they have structured their data allows them
only to assess exposures and risks in gross age classes-say, kids
between the ages of one to 5, or 2 to 6.
PAGENO="0036"
32
If you look at this chart over here on the left, you see some
rather dramatic changes occurring between that period that could
have toxicological significance to a young child. So the limitations
in the data that they have available to them as well as the way
they use that data all would cause them not to be able to assess
these risks, and I don't believe that their current methods are ap-
propriately protective.
The CHAIRMAN. I think, Professor Wargo, you mentioned the
data available is 13 years old; is that correct?
Mr. WARGO. Yes, that's correct.
The CHAIRMAN. Do you have recommendations as to how that
can be upgraded? I suppose it is by simply requiring the producers
to make that information available, much as we try to do in the
legislation. But how do we address that particular challenge? The
FDA is inundated at the present time. We've got a good director
there now, attempting to do the job, but how are we going to get
that kind of information? Whose responsibility is it?
Mr. WARGO. Well, if you require that residue data be collected
that is statistically reliable for the purposes of exposure assess-
ment, and you require that consumption data be collected that is
statistically reliable that allows you to go back and project these
risks onto subpopulations of children or, as Dick Jackson was sug-
gesting, children who are vegetarians who live in California, this
data needs to be recent, it needs to be designed statistically specifi-
cally for the purpose of exposure and risk assessment. It is not a
difficult thing to do. It takes money, and it takes time.
If I were going to characterize the current regulatory system, I
would say that it was either designed by Rube Goldberg or Oliver
North in terms of legislative responsibility allocated to the differ-
ent agencies.
EPA sets standards. USDA is responsible for assessing benefits.
FDA is responsible for monitoring and enforcement. My gosh, you
are setting up a system here that is so complex, that requires these
people to talk to one another. They all use different computer
coding systems that make it very, very difficult to come to a con-
clusion about what the level of exposure is out there. This responsi-
bility, in my mind, should be centralized.
The CHAIRMAN. How do you respond, both of you, to the sugges-
tion that if we follow this kind of criteria which you have indicated
to be necessary in terms of the protection of children, aren't we
really looking for confusing arithmetic? What's wrong with spread-
ing this risk over 70 years? So admittedly, there is greater risk in
the early years and less going on, but we're talking about impreci-
sion and about these particular pesticides. If we decide that it is
over a lifetime of 70 years, it is somewhat front-loaded to an
extent, but it is over a longer period of time. Plus we show that
though there is a special sensitivity in children due to their body
weight, rapid organ development, and eating patterns, it is still a
one in one million standard: it is a pretty safe standard. Why don't
we just look at it over that period of time? What's wrong with
that? Otherwise we're going through this complicated arithmetic
and bureaucratic regulatory process, which is going to mean a con-
siderably more costly food supply for the American consumer, and
that the American consumer may very well eat other kinds of
PAGENO="0037"
33
products which won't be as healthy for them. Therefore, in terms
of the total issue, we are really acting counterproductively.
Mr. WARGO. One response is that most tumors seem to take a la-
tency period of 20-40 years to develop. And most theories of how
tumors do develop are thought of as being multistaged in their
character. In other words, a cell would have to be hit by an onco-
genic agent on more than one occasion, and there are various theo-
ries about how many times that must occur. But I think quite
clearly you could understand that if a child were initiated, so to
speak, if a child's cells were hit by a toxic agent early on, they
have a much longer period of life when later stages might occur.
So it is a statistical issue of increasing the probability of tumor
development over longer periods of time.
The CHAIRMAN. Dr. Jackson.
Dr. JACKSON. The practical reality is that radiation exposure,
known carcinogen, if it occurs early in life greatly increases a
child's risk of cancer. Diethylstilbestrol exposure, if it occurs
during a little girl's development in utero, greatly increases her
risk of ultimately developing genitourinary cancer.
Early cancer is a tragedy for the family where it occurs, and
clearly we ought to be focusing on protecting at the early phases.
The CHAIRMAN. I am well aware of that.
Let me just ask you-and then my time is up-whether you feel
that the sense of urgency about this particular issue is sufficient
that we would be acting responsibly-in establishing the kinds of
standards which you both have commented on, before the Academy
of Science makes its recommendation? I imagine that this is really
a political judgement, but it is a judgement that must be made by
people who know this question and issue well.
Dr. JACKSON. My suggestion, Senator, if I may is that I believe
the system is broken. I believe it needs to be fixed. If the Academy
of Sciences report comes out that would change anything, perhaps
the committee would want to think about a way to leave some lati-
tude to adjust certain of the risk assessments to accommodate what
came out in that report.
But I don't see anything in this piece of legislation that doesn't
appear to me to be obvious common sense. I would just recommend
that you go with it now, and then if adjustments need to be made
later, go ahead.
The CHAIRMAN. Professor Wargo?
Mr. WARGO. I would agree with that. Another way of interpret-
ing Chart 2 here is to think about the implications of regulatory
delay. A one-year delay for a single chemical could cause a substan-
tial increment in risk, one that I think people are not comfortable
with. So I guess my argument would be that I would like to see the
standard in place as quickly as possible; that the improvement in
making the tolerances health-based occur as quickly as possible.
These 10-, 15-, 20-year delays in the regulatory process allow in
my mind unacceptable levels of risk to be accumulated, particular-
ly in children.
The CHAIRMAN. Senator Kassebaum.
Senator KASSEBAUM. Thank you, Mr. Chairman.
I am sure those of us who followed this through last year's
debate, many had hoped that there could have been compromises
PAGENO="0038"
34
worked out last year to resolve the issue, and it seems like deja vu
all over again.
On the other hand, I think we all agree that the legislation that
we're talking about, the Federal Food, Drug and Cosmetic legisla-
tion, has not been significantly changed in the last 20 years, and it
is important to address the issue in a way that the public has some
confidence that indeed we are trying to, as you say, make sure that
the current methods are protective-I think, Dr. Jackson, that was
the word that you used-and that the current methods that we are
using, you both question.
I would simply say-and I'd like to make my full statement a
part of the record, Mr. Chairman--
The CHAIRMAN. It will be included in the record.
Senator KASSEBAUM. [continuing]. That before everybody stops
eating bananas, that I don't believe you added that aldicarb has
been temporarily stopped and voluntarily withdrawn from the
market. That didn't occur until the first part of June, and I'm sure
that the questions that were raised prompted this action, but I
think that the manufacturers are to be complicated for taking that
action and recognizing that further research needed to be done.
Dr. JACKSON. I would like to clarify that point that as soon as the
information was brought by the manufacturer to EPA that clearly
the manufacturer and the banana producers acted in an extremely
responsible way, did not allow entry of bananas from aldicarb-
treated fields into the United States-even the suggestion that
someone could become ill caused them to change their marketing
patterns-and I absolutely agree that they should be commended,
and I'd like to make that clear.
Senator KASSEBAUM. Because I think it is important. Something
like this goes out, and everybody then gets alarmed, and that's my
concern with this issue, that out of our desire to try to find some-
thing that works and put a legislative vehicle together that allows
for some flexibility, we don't also raise such alarm bells which
cause people to stop eating bananas or stop eating apples, and we
try to address it in a responsible way, that we don't use the worst-
case scenario necessarily because I think the public as a whole has
become absolutely-it's a little like the little boy crying "Wolf'.
They don't understand, and each week there seems to be something
new that may be hazardous to one's health.
And I think if we want to convince the public that we're all re-
sponsible in this issue, we have to do it in such a way that, as I say,
we don't take a worst-case scenario and let it become the headline.
And as we sort through the solution in these hearings, I hope that
this will be valuable.
I was interested in your suggestion, Dr. Jackson, that the trade-
offs be made public, that without just sort of alarmist bells going
off all the time that there is again a greater sense of perhaps ac-
countability in what is made public so that the public can assess
and understand exactly what is happening, and for the public's
protection of health, there may be tradeoffs that have to be made.
But given that, at least we have addressed it in an honest fash-
ion. I come from an agricultural State, Kansas, and this has fre-
quently been an issue that has pitted the environmentalists, so to
PAGENO="0039"
35
speak, against the agriculture interest or agriculture-related inter-
ests. We all have agricultural interests in our States.
But I think those who are engaged in agriculture want to be re-
sponsible as well, and finding the best legislative compromises to
do so, so that we can make sure the health problems are addressed.
When you were talking about the bananas, I couldn't help think-
ing of my 15-month-old grandson, who eats a lot of bananas. Well,
again, I think it is terribly important that we make sure that the
public is not going to become so frightened of this that we all
wonder whether we should or should not eat bananas.
Dr. JACKSON. Senator, I have sort of a cognitive dissonance about
this because I end up wearing two hats. As a physician who is
called by fellow physicians saying their patients are coming in, and
people are in a panic about something, my response is, no, you
don't need to run out and dump the apple juice down the drain.
You don't need to worry about individual bananas. But from the
public health side, the people who are organizing or in charge of
this system, who are deciding what is allowed, who are making de-
cisions for 200-300 million people at a time, have very serious re-
sponsibilities, and when those fail to be met-and frankly, I think
they were not met in the whole issue around alar-it ends up on
the individual mother's breakfast table when she is trying to make
sense out of something that should have been dealt with in a regu-
latory process years before.
So I couldn't agree with you more. This is not something that we
in any way want to put before the public and alarm them with. It
ought to be fixed before that.
Mr. WARGO. Senator, if I could comment briefly, I think you are
raising a very important issue with respect to benefits, and the
standard that is being proposed is an alternative to risk-benefit bal-
ancing. It is simply a health-based standard rather than a risk-ben-
efit balancing standard.
Let me make two points about benefits. There are no clear guide-
lines on how benefits associated with the use of a chemical should
be expressed. Traditionally, if you look in the Federal Register at
the technical documents, they are expressed in terms of crop pro-
duction, potential job losses, farm income loss-all very important.
But there are other cost considerations that I think of when I think
of the concept of benefit. I don't think really of this process of risk-
benefit balancing as being that simple. I think of it as being risk-
benefit cost-balancing, because there are health care costs that are
associated with treatment of tumors-I had a student who went to
our medical school and found that the average cost of treating a
tumor at Yale University is $50-$100,000. If you take some of the
projections of number of tumors that are expected over a fair
number of years, you come to very large dollar figures, yet those
estimates are not included in the benefits equation.
So my argument really is that an expanded conception of bene-
fits and costs has to be considered.
Now, the other worry is if you implemented this standard, what
would the economic effects be. Would there be certain specific
crops that would take a much harder hit than others. I think the
answer is yes. But there are ways of mitigating that, including
phasing in the standard over time to allow for the introduction of
PAGENO="0040"
36
less risky chemicals and also to allow farmers to learn techniques
that do not require as extensive use of chemicals.
There is a very important and very interesting publication by
the National Academy Press that came out last year on alternative
agriculture, demonstrating the potential for maintaining crop
yields across a diverse set of crops without the use of agricultural
chemicals or with dramatically lower levels of chemical use. So
that this phasing in process of the regulation I think could mitigate
the distribution of costs that might be associated with the stand-
ard.
Senator KASSEBAUM. I think you both have had very valuable
testimony, and I certainly appreciate it.
Thank you.
[The prepared statement of Senator Kassebaum follows:]
PREPARED STATEMENT OF SENATOR KASSEBAUM
Mr. Chairman, I appreciate having the opportunity to express
my concerns regarding 5. 1074.
Given that the Federal Food, Drug, and Cosmetic Act has not
been significantly am,ended in 20 years, it is no surprise that prob-
lems in the current regulations have surfaced. But I do urge cau-
tion in that the new legislation should allow ample flexibility in de-
termining risk/benefit calculations and should be based on sound,
reasonable science.
The current debate has often pitted those typically known as the
environmentalists against many in agriculture and agriculture-re-
lated industries. Overwhelmed by mostly good intentions and a bar-
rage of misconstrued statistics and reports, we are being confronted
with a number of misconceptions.
Dduring the past few years, those depicted as environmentalists
and those depicted as representatives of agriculture, including
farmers, have been "preaching to their own choir" in an attempt to
address this dilemma. Unfortunately, we have only succeeded in
blaming each other. I do, however, believe that it is clear that
changes in current law need to be made. I am hopeful that
throughout this dialogue common sense will prevail, thus allowing
us to address pesticide problems and many related misconceptions.
Now, I would like to comment briefly on 5. 1074. This bill con-
cerns me for several reasons. First, in order to address the concerns
of many consumers, I believe that risk standards must be devel-
oped which not only ensure that we have a safe food supply but
allow for flexibility to cope with new scientific developments. I
urge other members of this committee to recall that just 15 years
ago scientists could detect up to 35 parts per billion. Today, they
can identify one part per quintillion, due to these new scientific de-
velopments, provisions, such as the Delany Clause, which mandates
zero risk for carcinogens in processed food, must be revised. I am
pleased that 5. 1074 addresses the Delany Clause, but I am con-
cerned that other risk standards are too strict. One must keep in
mind that dietary factors, excluding pesticide residues, tobacco use,
and other infections are, by far, the biggest contributors to cancer
in our society today. Consequently, I believe that we must keep this
issue in perspective by allowing the environmental Protection
PAGENO="0041"
37
Agency to adopt reasonable risk assessment models with allowed
flexibility to accommodate evolving science.
Regarding risk/benefit analysis, I firmly believe it is vital that
we include both health and economic benefits in determining al-
lowable tolerance levels. Unfortunately, this legislation contains
neither. Although I agree that we must try to lessen the use of ag-
ricultural chemicals, I believe that we must also face the reality
that pesticides can provide vital health and economic benefits to all
consumers.
I am disappointed that 5. 1074 fails to address national uniformi-
ty of tolerances. As we are all aware, this issue has created much
controversy. Although there may be circumstances whereby States
may desire stricter tolerances, I believe that, in general, uniform
tolerances are needed. If a substantial number of States were to
start establishing a myriad of tolerances, I am concerned that the
impact on trade and agriculture could be substantial. The issue of
national uniformity has been debated for some time, and I am
hopeful that a reasonable compromise can be reached. But I do be-
lieve that any pesticide legislation will have to face this problem.
Mr. Chairman, this is an important and complex issue which is
being addressed by several pieces of legislation in various commit-
tees. Because this issue affects everyone from the farmer to the
consumer, I believe we should be careful and deliberate in our ac-
tions. I am hopeful that the final outcome will produce some har-
mony between FFDCA and FIFRA. Both of these acts concern pes-
ticides and their use, and it is of paramount importance ton ensure
that both acts work together.
The CHAIRMAN. On that last point, with the children's standard,
we're not talking about many items, are we? We're talking about
15 or 18 or so?
Mr. WARGO. We don't really know yet, Senator. My guess is that
if you chose the 10 most consumed foods by children, and you
looked carefully at the chemicals that were allowed for use on
those 10 foods, you would find that there were maybe half a dozen
chemicals to a dozen chemicals that would be influenced by this
standard.
The CHAIRMAN. But I think it is important that while we're talk-
ing about the children's standard we establish that we're talking
about a rather limited, although very important area in regard to
the kinds of items being consumed by children, are we not?
Mr. WARG0. Yes, that's very accurate.
The CHAIRMAN. We don't want it to be thought that this is just
going to be a broad-based agricultural kind of an issue. I think that
is important.
Senator Dodd.
Senator DODD. Mr. Chairman, I would just thank you for holding
the hearing and note that one of your witnesses here is a professor
at Yale and not at Harvard, which is encouraging.
I read your testimony, and one can get lost-I was particularly
interested in "disjointed incrementalism" which you made refer-
ence to here.
I have a particular interest, of course, in children, and we held
hearings here a year or so ago on alar-in fact in this very room-
and I was stunned to discover that EPA was only considering one
PAGENO="0042"
38
chemical at a time. There is always a danger with those of us who
really are laymen in this kind of a debate. But, it did seem to me
on its face to not make a great deal of sense if what you were
trying to determine were the cumulative effects-particularly on
infants.
I guess the only question I'd raise-although Senator Kennedy's
last question mitigates it to some extent-is to what extent we're
in sort of a bureaucratic gridlock here. According to your testimo-
ny, we're looking at some 320 pesticides allowed for use on food,
along with some 1,200 inert ingredients. It seems to me there ought
to be some sense of priority.
Prior to getting into all of this, is there enough knowledge to
work off of that you or someone who is knowledgeable enough,
could take a look at that list and say, well, at least based on what
we know right now, our attention and our priorities ought to be fo-
cused on these 10, or these 5, or these 20, or whatever the number
may be. Would someone be able to get some sense of. priority, given
the fact that there has not been enough support and funding for
the personnel levels?
We have all heard from the EPA the difficulties they have just
in managing and doing a good job, and I have a certain degree of
sympathy for that. It seems to me, though, that facing this reality,
there ought to be some way to prioritize this list a bit. We need to
give those who are least able to defend themselves or who are most
dependent on a relatively small amount of food sources, and at
their earliest stages of their development the highest priority.
Then as the danger lessens as you point out in your testimony, that
list of priorities expands.
Is that possible, or am I being terribly naive by suggesting that
there is a way of dealing with the problems of lack of personnel
and at the same time prioritizing a list?
Mr. WARGO. I think it is an outstanding suggestion. EPA officials
should not take any of my comments as criticism of them. I have
numerous friends and colleagues inside EPA and also many stu-
dents inside EPA, and my impression of the quality of work is out-
standing.
Senator DODD. I agree with you.
Mr. WARGO. This problem is not their problem. The problem is
the result of the way the law is structured and also the allocation
of budgetary resources. They are not in the business of trying to
push risk on kids. They are trying to do the best job they can,
given extremely limited resources.
The jdea about establishing priorities is an outstanding idea.
They have done that within the agency. Unfortunately, the regula-
tory review process proceeds chemical by chemical. The last time I
counted, the number of chemicals that are allowed for use on
apples was 110. For oranges, it was about 105. This is the number
of tolerances that exist in the Code of Federal Regulations.
If you use computer simulation to see what the effect of cancel-
ling one chemical that you think of as a bad chemical, posing too
much of a risk at one point in time, without consideration of the
possible substitutes, you run the risk of actually increasing risk be-
cause a farmer is forced into using a more risky chemical. So these
chemicals have to be looked at in concert across foods, and it is a
PAGENO="0043"
39
very difficult thing to do because of the way that the data has been
requested chemical by chemical.
The other question you raised was is it possible to isolate particu-
lar foods and particular chemicals so that we can attack this thing
quickly. My answer is yes. My guess is that if we chose 10 foods,
primarily fruits and vegetables, that we would not have to deal
with more than perhaps a dozen chemicals to substantially reduce
the level of exposure in the food supply. I think it is an outstanding
idea and one that is clearly feasible given the State of computer
technology as well as the State of data that is available to the
agency and now to other people.
Senator DODD. Dr. Jackson.
Dr. JACKSON. I agree. We ended up doing the same thing in Cali-
fornia when a bill went through called the "Birth Defects Preven-
tion Act" that said fill the data gaps on pesticides. There were
meetings where it was decided that trying to fill the data gaps on
1,200 active ingredients all at once didn't make any sense. Priority
needed to be set for those that had the most use and people were
the most exposed to.
Senator DODD. Thank you.
Thank you very much, Mr. Chairman.
The CHAIRMAN. Senator Cochran.
OPENING STATEMENT OF SENATOR COCHRAN
Senator COCHRAN. Mr. Chairman, let me thank you for conduct-
ing the hearing and bringing the committee to look at the issues
that we're debating and discussing this morning.
I am hopeful that this exercise will produce a consensus for some
changes that are needed in regulations and the laws on which
those regulations are based to help ensure that we do have a scien-
tifically based approach to improving the safety of our food supply.
I think that is an important goal, and if that is the goal that we
are seeking to achieve then I fully support the effort.
I want to say also that I think the bill that is the subject of this
hearing takes some very positive steps in the right direction. Its
provisions to eliminate the inconsistencies in the regulation of raw
and processed foods, for example, is encouraging, and the acknowl-
edgement I think implied in the bill as well that the Delaney
clause is an unrealistic and unnecessary means of ensuring safe
food is also encouraging. That requirement is a zero risk standard.
It may sound good, but from a practical standpoint it is not very
realistic as a standard.
The fact is that some carcinogens occur naturally in foods, but
the level is so low that there is statistically no risk of cancer to
anyone who consumes those foods. Consequently, to require .a zero
risk standard is to be more stringent than nature is itself in the
production of food.
I compliment the chairman on his leadership in directing atten-
tiOn to problems like this, and I want to be a part of the effort that
the committee is making to ensure that American foods that are
available to consumers in this country are the safest possible.
I am encouraged when you look at comments that have been sub-
mitted to the committee. I think already in the record, Dr. Everett
PAGENO="0044"
40
Koop, our former surgeon general, states in a comment for the
hearing record, and I'll quote: "There is no scientific evidence
showing that residues from the lawful application of pesticides to
food have ever caused illness or death."
I understand that already one of the witnesses has talked about
the problems that have been caused that have come to his atten-
tion because of illegally applied pesticides. That's not something
that is addressed by this bill. We are not talking here today about
trying to deal with that. Those are already illegal applications and
illegal uses which would be sanctioned under current law, not this
legislation.
So I hope that what we try to do is keep our attention focused on
the issue before the committee, and that is the legislation and what
we are seeking to do to improve the possibility for making safe
American food even safer.
The CHAIRMAN. Fine. We'll be glad to receive those questions and
include the statement in its entirety.
Senator Simon.
Senator SIMoN. Thank you, Mr. Chairman.
First, just so I understand, Professor Wargo, when you say "mul-
tiple U.S. average" for apple juice, 14.9, for instance, that means
that an infant consumes 14.9 times as much as the average citizen;
is that correct?
Mr. WARGO. That is the result of the 1977-78 food consumption
survey, which basically means that in 1977 and 1978, the children
who were surveyed at that time on average consumed that amount
more than the U.S. average.
Senator SIMON. You both referred to the National Academy of
Sciences committee report. When is that going to be coming out?
Mr. WARGO. My best guess now is sometime early in the winter.
Senator SIMON. In response to Senator Dodd's question, you both
talked about having a priority of a dozen things that are really
consumed. And you also talked about the Rube Goldberg structure
that we have. Right now, how do we get that decision made? Who
makes that decision?
Mr. WARGO. Well, my guess would be that EPA would make that
choice; that they would decide to regulate not chemical by chemi-
cal. I may be wrong. You could ask Linda Fisher that question. But
my sense is that if they wanted to regulate many chemicals at the
same time, they could do that. They could establish a multichemi-
cal priority list and multifood priority list.
Senator SIMON. I know this is going out of order, Mr. Chairman,
but Linda Fisher is right back there. This makes so much sense to
me. Is this something that EPA can do, and something that we
don't need to be directed by statute to do?
Ms. FISHER. Thank you, Senator. It is intuitively a very good
idea, but it is a very difficult one. Two points. First of all, in 1988
the Congress passed amendments to FIFRA which put the agency
on a very strong timetable to regulate chemicals, so over the next
10 years we will be getting a lot of data on all the chemicals that
are currently in use. So we are kind of bringing together the
review of all these pesticides in, I think, a pretty prompt time
frame, much quicker than we've ever dealt with them before.
PAGENO="0045"
41
In meeting those time frames, we have already started request-
ing data from the chemical companies, and we have established a
priority. For instance, the first target chemical group were the food
use chemicals. There are about 194 of those. They are called the
"List A" chemicals. Within that, each chemical is on a little bit dif-
ferent time frame mainly because of the data and the amount of
tests that are required to be done. So for instance, for one chemical
that we have a lot of data gaps, it may take three or 4 years for the
chemical companies to perform the necessary tests. That means de-
cisions on those chemicals will be a little bit more delayed.
So we have tried to set some priorities. We have focused on food
use. But there are some problems that we are going to run into just
in terms of getting the information we need to make decisions.
Senator SIMON. But when you say you focus on food use, are you
focusing on those that are most used?
Ms. FISHER. Within the food use category, we have not necessari-
ly set a priority. Again, part of it depends on when the information
will come to us to make a decision. So we have not looked to see
what is used most on apples versus milk, or that would show up in
milk or something else.
Senator SIMON. I think this just makes an awful lot of good
sense, and I would simply urge that what is used the most be deter-
mined, and then let's make a priority out of those things. Let's
move in that direction. It doesn't mean you don't continue your
studies in the other things.
Ms. FISHER. We can try to do that. The information is probably
our biggest challenge to do that.
Senator SIMoN. All right. Maybe between EPA and the National
Academy of Sciences Committee somehow we can get that informa-
tion together. OK. Thank you.
I have just two other questions. Dr. Jackson, you mentioned
going to a migrant camp, and three people were sick from some
chemical. Has that been reported to someone, or is it required that
it be reported?
Dr. JACKSON. There is what is called the Pesticide Illness Surveil-
lance System, which is in place in the Federal Government. Cali-
fornia has had a much more stringent and aggressive one than
what exists in the rest of the country. In fact, we report about half
the pesticide poisonings in the Nation because such episodes are
aggressively reported. In fact, doctors are fined if they fail to report
pesticide poisoning.
Several other States have obligatory reporting laws where they
are tracked down. But in general the surveillance, particularly in
some States, for worker illnesses is very, very poor.
If I may, I just want to come back to Senator Cochran's point. I
had pointed out that illness episodes in the past, yes, had been due
to illegal uses-the watermelons-but I guarantee you if a press re-
lease had gone out saying if you think you had gotten sick from a
banana, and 10,000 or 100,000 bananas arrived at EPA's doorstep
for analysis, that we would have found illness associated with resi-
dues in bananas. It just would be a dumb way to detect the cases. It
makes much more sense just not to have the problem, to prevent
the stuff from being there in the first place.
PAGENO="0046"
42
Senator SIMON. But if I can get back to my question, right now
the option is with the State?
Dr. JAcKsON. The Federal Government runs the system, but its
penetration into the various States is very variable. Some States do
it well; some States don't do it at all.
Senator SIMON. So that we ought to be looking at strengthening
that.
Dr. JACKSON. I would agree with that. In fact, if I may, the Na-
tional Institute of Occupational Safety and Health has a project in
place called the "Sensor Project" where they are trying to beef up
the tracking down of pesticide illness cases because for every
severe episode, there are many more that are much more subtle
that really could be prevented at the same time.
Senator SIMON. Professor Wargo, you said we have a terrible
structure, one that needs to be centralized. I have just one very
simple question: Who takes charge in the centralization?
Mr. WARGO. In my mind, the leadership in this area is found
inside EPA. They have the expertise to design the consumption
surveys. They have the expertise in the area of chemical residues.
This fragmented, as Senator Dodd paraphrased me, "disjointed in-
cremental regulatory approach" is going to be a very difficult maze
to work out of unless centralization occurs.
Senator SIMoN. Thank you.
Thanks for excellent testimony.
The CHAIRMAN. Dr. Jackson, Senator Cochran isn't here, and I
don't know whether there is any comment you wish to make in
terms of Dr. Koop's statement.
Dr. JACKSON. I agree with Dr. Koop that in general the food
supply is safe. I think that commercial aircraft is safe, but no one
is saying that it couldn't be better. And I think that is what this
bill is after, is to make it better.
The CHAIRMAN. OK. We'll probably have some additional ques-
tions, and we'll try not to overburden you, but we hope to be able
to take advantage of your expertise as we move the legislative
process forward.
We thank you very, very much. Your testimony has been enor-
mously helpful.
Our second panel is comprised of Linda J. Fisher, assistant ad-
ministrator of the Office of Pesticides and Toxic Substances at the
EPA; Fred R. Shank, director of the Center for Food Safety and
Applied Nutrition at the Food and Drug Administration, and
Daniel Haley, administrator of the Agricultural Marketing Service,
Department of Agriculture.
We'll start off with Ms. Fisher.
PAGENO="0047"
43
STATEMENTS OF LINDA J. FISHER, ASSISTANT ADMINISTRATOR,
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES, U.S. ENVI-
RONMENTAL PROTECTION AGENCY, WASHINGTON, DC; FRED R.
SHANK, DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED
NUTRITION, FOOD AND DRUG ADMINISTRATION, WASHINGTON,
DC; AND DANIEL D. HALEY, ADMINISTRATOR, AGRICULTURAL
MARKETING SERVICE, U.S. DEPARTMENT OF AGRICULTURE,
WASHINGTON, DC
Ms. FISHER. Thank you, Mr. Chairman.
I am pleased to have the opportunity to appear before the com-
mittee today to discuss your bill dealing with pesticide and food
safety.
The administration has made food safety a priority, and we
strongly support legislation to effect the President's seven-point
food safety plan. It has long been a priority of yours and the other
members of this committee, and I do appreciate your continued in-
terest in trying to improve the laws that govern this issue.
Our approach to the legislation does differ from yours in several
important respects, and I'd like to focus both on the differences as
well as the similarities.
Although we differ on our approach to risk standards, there are
certain important areas of agreement. Your bill and the adminis-
tration approach both replace the Delaney clause with a uniform
negligible risk standard. The general safety clause of your bill re-
quires that a tolerance be reasonably certain to cause no harm to
human health, and that is essentially consistent with the adminis-
tration approach to food safety.
The bill's basic requirement for negligible risk, or one in one mil-
lion for carcinogens and a 100-fold safety factor for threshold ef-
fects, while too inflexibly applied, do not differ drastically from
EPA's current standard practice.
In the great majority of cases we do regulate cancer risks near
one in one million, and we do apply a 100-fold safety factor to pro-
tect against other risks.
The problem we see is that under your bill the actual risk stand-
ards could end up being far more stringent in practice than they
appear. In other words, while the bill seems to establish a risk
level of one in one million, it could force EPA to regulate at an
actual level of one in 100 million or lower. This is because of the
bill's various provisions on risk assessment and risk management,
that are both highly restrictive and cumulative.
Specifically, the bill's exposure provisions require us to use only
full tolerance values, which tend to be much higher than actual
residues in calculating exposure. This assumption alone could lead
to an overstatement of risk by 10- to 100-fold.
In addition, the bill's treatment of childhood exposure would
make the risk standard even more restrictive. Under EPA's cur-
rent approach we do take into account the fact that children eat
more of certain foods and more per pound of body weight than
adults do, and therefore can be more highly exposed during their
first 5 years of life. This does weigh heavily in our risk assessment
calculations and in our regulatory decisions.
PAGENO="0048"
44
Under your approach, we would have to go even further and
limit risk for each of the first 5 years to one-seventieth of one in
one million. For a given pesticide, this added limitation could make
the standard two to ten times more stringent.
We recognize that the bill seeks to achieve two worthy goals in
protecting children and in improving the quality of our databases,
and here again the administration supports the goals but takes a
different approach to meeting them.
We now take children's higher exposure into account in our risk
assessment and our decisions, and we have asked the National
Academy of Sciences to advise us on whether our process is protec-
tive enough. We are unsure as to the scientific merit of the year-
by-year approach set out in your bill, but perhaps the National
Academy of Sciences report will shed some light on this as well.
We also agree that food consumption data on which we base our
decisions needs to be stronger than it is today, and we are working
with FDA to improve it.
The administration approach to the FFDCA amendments also
contains two important elements which are not reflected in your
bill. First, we believe that the benefits of the use of a pesticide
should be considered along with risks in setting tolerances provided
that any tolerance we set is protective of public health.
Second, the administration has proposed national uniformity for
pesticide tolerances that are set prospectively and on the basis of a
complete data set.
The President's food safety plan also contains a number of key
amendments to FIFRA which would make our pesticide regulatory
program far more effective. We propose to strengthen FIFRA's pro-
vision to suspend and cancel pesticides, strengthen our enforce-
mént authorities and provide better interagency consultation as
well as a periodic review for pesticide registrations. FIFRA needs
these changes if we are to address pesticide and food safety issues.
There are also additional portions of your bill which we support.
It does clarify several EPA authorities and improves current proce-
dures. The deadlines for review of existing tolerances are also in
general accord with our registration scheduled under FIFRA 1988,
although I think it is important to point out that we have already
raised to the Agriculture Committee the fact that our resource con-
straints may threaten our ability to meet the FIFRA 1988 dead-
lines.
In sum, the administration approach to pesticides and food safety
does differ from those provided in your bill in several important re-
spects. We do, however, believe that legislation in this area is es-
sential, and we do look forward to working with you and other
members as we address this issue.
Thank you.
[The prepared statement of Ms. Fisher follows:]
PREPARED STATEMENT OF LINDA J. FISHER
I appreciate the opportunity to testify before you this morning on the need for
legislation that will effectively address important issues related to pesticides and
food safety. Clearly, food safety is a priority matter for U.S. consumers, and public
interest in these issues remains high. Food safety has long been a high priority for
this Administration, and we are continuing our efforts to make the U.S. food
supply-already one of the safest in the world-even safer.
PAGENO="0049"
45
Those of us involved in pesticide regulation and food safety matters share some
common legislative goals. We want to maintain and enhance food safety and con-
sumer confidence in the food supply. We want to ensure that our regulatory deci-
sions are sound, timely, and reflect the best, most up-to-date science. We also want
to ensure that the laws governing pesticide regulation and use can be administered
and enforced in a consistent and efficient manner that protects public health and
the environment. Legislation that advances these objectives will help ensure that
U.S. consumers will continue to enjoy a safe, wholesome, abundant and economical
food supply.
The Environmental Protection Agency (EPA), working in concert with the U.S.
Department of Agriculture (USDA) and the Department of Health and Human
Services and its Food and Drug Administration (HHS/FDA), is taking steps to
achieve these ends within the constraints of current law. But existing statutes are
far from ideal.
To be effective, regulatory agencies require workable statutes that give us both
the authority we need to make sound decisions based on the best available data, and
the tools we need to enforce our regulatory requirements. The Administration be-
lieves that new legislation amending both the Federal Food, Drug, and Cosmetic Act
(FFDCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIF) is neces-
sary to advance our efforts. Obviously, we are not alone in thinking that improve-
ments are needed. We want to work with Congress to enact effective, workable legis-
lation that will allow us to make further progress, bringing our pesticide laws more
in line with current science and providing a framework for continuing progress in
future years.
We are concerned, however, that as currently drafted, certain key provisions of S.
1074 have the potential to cause serious disruption that cannot be justified in terms
of anticipated food safety or public health gains. Our principal concerns relate to
the overly stringent standards set for risk management decision-making; the effect
of these standards in terms of exacerbating inconsistencies between FIFRA and
FFDCA; the omission of benefits considerations in the tolerance-setting process; the
lack of any provision for national uniformity of tolerances; and the inflexibility of
provisions that prescribe how EPA must conduct risk assessments.
I want to discuss each of these issues this morning and describe how EPA believes
our common legislative goals can be addressed most effectively. As legislative con-
sideration proceeds, I hope we will be able to make constructive progress toward the
development of the kind of legislation that will best serve the public interest and
lead to meaningful improvements in how pesticides are regulated.
STANDARDS FOR RISK ASSESSMENT AND TOLERANCE SETTING
As I indicated earlier, we are concerned that the laws under which we regulate
pesticide use work together efficiently. Central to our concern is the need for com-
patible standards to guide our decision-making under both FIFRA and FFDCA. As
you know, one critical point is how the llzero-risk" standard of the Delaney clause
of FFDCA can be reconciled with the risk-benefit balancing approach embodied in
FIFRA. The Administration strongly supports legislation that will bring the stand-
ards for pesticide regulation under FIFRA and the FFDCA into greater harmony by
eliminating the Delaney clause and establishing one consistent standard for negligi-
ble risk.
One area where we have reached some consensus with the sponsors of the legisla-
tion before your Committee is that a "zero risk" approach to regulating substances
that may be associated with cancer in laboratory animals is no longer appropriate.
We support the bill's elimination of the literal "zero risk" provisions of the Delaney
clause and the establishment of a negligible risk standard. However, the standards
that 5. 1074 would put in place of the clause raise new problems.
A major area of concern relates to the risk standards that the bill establishes. The
Administration supports legislation that will harmonize the inconsistent standards
that now apply to pesticide residues on raw and processed foods and establish a
single, protective standard for all residues in food. We interpret 5. 1074's statement
of the general safety standard, a reasonable certainty of no harm, as a positive step
in this direction.
For cancer risks, regulatory agencies like EPA have adopted conservative carcino-
genic risk assessment techniques that allow us to extrapolate from high dose animal
bioassays to the expected lower levels of human exposure. Generally, we have re-
garded carcinogenic risks in the range of 10 to the minus 6th-or an upper bound
increase in lifetime risk on the order of one in one million-as negligible, i.e., not of
significant regulatory concern. Both EPA and FDA have accepted this benchmark,
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while noting that the imprecision inherent in the assumptions generally made in
our risk assessments, and the relative strengths or weaknesses in the underlying
data, militate against the false sense of precision implied by adoption of a "bright
line" standard such as one in one million. We believe risks in this range, estimated
using our current risk assessment methodologies, clearly meet or exceed the bill's
general safety standard of "reasonable certainty of no harm.
At first blush, S. 1074 appears to accept 1 x 10 to the minus 6th as an appropriate
safety standard for pesticide residues in food. Upon closer examination, however,
the bill prescribes such rigid assumptions in the calculation of risk estimates, par-
ticularly in terms of how EPA must assess exposure, that the net effect is to estab-
lish a much more stringent standard, perhaps as much as several orders of magni-
tude more conservative than 10 to the minus 6th. Even if EPA had sound data that
would enable us to refine our exposure analyses and arrive at a more realistic esti-
mate of risk, S. 1074 would not allow the Agency to use many types of data we now
rely on in making tolerance decisions.
For example, EPA's current practice in its initial estimation of exposure for
chemicals that raise chronic toxicology concerns (such as carcinogenic risk) is to
assume that all pesticide residues are present at tolerance levels on foods for which
there are tolerances, unless we have empirical data (e.g. from "market basket" or
supermarket surveys) that more closely represent actual dietary exposure. We rec-
ognize that using this "theoretical maximum residue concentration" (TMRC) in
most cases significantly overstates actual, risk, in a number of instances by factors
of 10 to 1000.
If there are no apparent risk concerns assuming worst case scenarios, we will gen-
erally proceed no further with our exposure analysis. If there are potential con-
cerns, we will seek to obtain additional information to more accurately refine our
exposure estimate. This information includes data on average field residues; percent
of crop treated; actual residue levels in food at the time of sale; chemical degrada-
tion over time; or the effects of processing, washing, peeling or other food handling
and storage practices.
As we read the terms of S. 1074, EPA would no longer be able to use most of these
types of data in risk assessment. The only adjustments to our worst case scenarios
would be for percent of crop treated (in certain limited circumstances), and for the
effects of food processing to the extent that EPA could use data from processing
studies to establish separate tolerances for processed foods at a lower level. Data on
residue levels at the point of sale of food could not be used. Nor would 5. 1074 allow
EPA to consider information indicating that pesticides may be used less frequently
and at lower application rates than permitted by the label, or that residues decline
over time. EPA could not consider the fact that residues from even the highest ap-
plication rates are, on average, 3 to 5 times lower than tolerance. (This is. because
the Agency's practice is to set tolerances at levels designed to ensure that farmers
who use pesticides in accordance with EPA-approved labeling will not be subject to
product seizures or other enforcement actions.)
The effect of these proposed statutory constraints on calculating exposure is sig-
nificant. It could transform the nominal standard of 10 to the minus 6th into a
standard of perhaps 10 to the minus 7th to 10 to the minus 8th or more over a life-
time. Other provisions defining the negligible risk standard, and prescribing the as-
sumptions that EPA must make, could further exaggerate the calculation. Notably,
provisions establishing a second risk standard for nonthreshold effects based on ex-
posure to young children and data requirements for subgroup analyses compound
the effect. These provisions are discussed in greater detail later in my statement.
The overall result of compounding all of these assumptions and standards would
force the Agency to regulate at levels that would eliminate many pesticide uses,
without achieving meaningful incremental reductions in risk.
The bill's provisions for establishing tolerances for chemicals that induce "thresh-
old" effects for which EPA has identified an apparent "no observable effect level"
(NOEL), need flexibility. The Agency generally uses an uncertainty factor of 100
when extrapolating from animal data. However, there are situations in which a
smaller uncertainty factor can be justified on the basis of scientific data. For exam-
ple, if we know that humans and the tested species react in much the same way at
the same dose, there may be no need for the full order of magnitude uncertainty
factor commonly used to allow for between-species differences.
A final concern in terms of the risk standards imposed by S. 1074 relates to the
treatment of chemicals that may induce non-cancer, non-threshold effects. The bill
places any toxic effect for which EPA has not established a NOEL, or apparent
threshold dose, into the same category as carcinogenic effects. Such effects include
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idiosyncratic reactions and other effects, such as mutagenesis, for which we are not
always able to identify a NOEL.
The techniques used in carcinogenic risk assessment and the associated 10 to the
minus 6th benchmark figure were developed over the last 15 years or so, based on
conservative methods of extrapolating data from high dose animal bioassays to
lower dose human exposures and the default assumption that all carcinogenic re-
sponses are without an apparent threshold. The resulting numbers do not represent
actuarial risks, but theoretical upper bound projections based on protective assump-
tions about carcinogenesis.
The original techniques developed for assessing potential carcinogens may have
no scientific validity if applied to other effects. In fact, we are beginning to suspect
that these methodologies may be inappropriate for certain specific carcinogenic re-
sponses.
Although we recognize the need to rigorously regulate for these types of health
effects, carcinogenic risk assessment techniques are not appropriate for the assess-
ment of these types of risks. EPA must have flexibility to evaluate potential idiosyn-
cratic reactions and other effects for which no clear dose-response or NOEL can be
described. The science for studying and assessing non-cancer effects must be given
the opportunity to develop, and not forced indiscriminately into the cancer mold.
Neither of the two categories in S. 1074 is necessarily appropriate for these kinds of
risks, and therefore we suggest the Agency be allowed flexibility in dealing with
non-cancer, non-threshold effects.
One of the major criticisms of a literal approach to the Delaney clause in recent
years has been that it tended to "freeze the science," making it difficult for EPA to
use the latest advances in our understanding of risk assessment and carcinogenesis
in regulatory decision-making. S. 1074 should be amended to delete provisions which
could have the effects of freezing scientific risk assessment and retarding EPA's
ability to reflect advances in scientific understanding of both cancer and non-cancer
effects in our regulatory decisions.
PROTECTING CHILDREN FROM PESTICIDE RISKS
S. 1074 places particular emphasis on infants and young children. Clearly, we at
EPA agree that our tolerance decisions should ensure that no element of the popu-
lation, including the very young, is subject to unreasonable risk from dietary expo-
sure to pesticide residues. The provisions included in S. 1074, however, impose new
standards that, while aiming at a commendable goal, go beyond what can be justi-
fied in terms of current science. Particularly when placed on top of other provisions
of the bill, the compound effect of these provisions would be an overly rigid, overly
stringent standard for tolerance setting.
As we have already discussed, S. 1074 sets a nominal overall risk standard for
cancer and other non-threshold effects of 10 to the minus 6th. In addition, the bill
would require a second standard to be met, "one in a million divided by 70 for any
single year of exposure during the first 5 years of life." As a practical matter, for
many if not most foods eaten by children, this second standard will drive the toler-
ance decision. Again, the effect is to go beyond the nominal 10 to the minus 6th
standard, making it 2 to 10 times more stringent, depending on how commonly the
food is consumed by children. The reason for this is that children, in general, con-
sume proportionally more food for their size than adults.
EPA has historically paid particular attention to potential effects on children in
our regulatory decision-making. We pioneered the concept of assessing risks by age
group. Our DRES subgroups include nursing and non-nursing infants less than 1-
year old; children in the age groups 1-6 years and 7-12 years; adolescents 13-19
years (males and females separately); and nursing and pregnant females. Routinely,
in assessing pesticide risks, we evaluate children's proportionally higher exposures.
EPA will take regulatory action when data exist to indicate that children may be
particularly vulnerable to adverse effects; examples include our lead strategy and
the establishment of maximum contaminant levels for nitrates in water supplies.
EPA is also taking steps to increase our scientific understanding of factors that
may make children more, less, or differentially susceptible to adverse effects, and
how best to evaluate dietary risks to this special population group in our pesticide
regulatory decisions. The National Academy of Sciences (NAS) is conducting an on-
going study for EPA on this issue, and we expect to receive the report early in 1992.
Our food safety laws must provide the flexibility EPA will need not only to act ap-
propriately on the NAS recommendations, but also to adapt our policies in the
future as new knowledge is developed.
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48
At this time we know of no valid scientific basis for S. 1074's special risk standard
of 1/70th of 1 in a million for each of the first 5 years of life. It appears to be based
on an assumption that children are, in all cases, more sensitive to nonthreshold ef-
fects than are adults. To date, the science simply does not support such an assump-
tion. The limited data available indicate that in some cases there may be greater
sensitivity; in some cases children may be less sensitive, (for example, due to their
higher metabolic rate); and in still other instances children may respond in a
manner completely different from adults. In any event, differences in sensitivity are
not likely to be as significant as differences based on the relatively larger quantities
of food children consume for their size, an effect EPA does take into account.
A second provision aimed at children is the requirement for data on exposure/
consumption for the age groups 0-1 year, 1-2 years, 3-4 years, 4-5 years, 6-10 years,
and 11-18 years. As discussed below, the Dietary Risk Evaluation System (DRES)
does not now provide breakdowns for all of these subgroups, and there are likely to
be too few observations in the individual year-by-year age categories for a number of
foods. We are unsure of the value of requiring such specific information on narrow
age groups, and as stated above, we believe it could potentially have an adverse
effect on the food supply.
BENEFITS CONSIDERATIONS
A third major focus of concern regarding 5. 1074 is the lack of any provision al-
lowing consideration of the benefits of pesticide use in tolerance setting. EPA
strongly supports a change in the law to allow consideration of benefits in all toler-
ance decisions, provided that any tolerance we set must protect the public health.
Under current FFDCA, benefits are considered in the establishment of tolerances
for pesticide residues on raw agricultural commodities as required by the law's pro-
vision that we take into account the need for the production of an "adequate, whole-
some, and economical food supply." While we will only set tolerances which we be-
lieve are protective of the public health, our decisions reflect consideration of the
overall societal benefits of a pesticide's use. Failure to continue this policy only ex-
acerbates the existing inconsistencies between our two key pesticide regulatory stat-
utes, FIFRA and FFDCA.
IMPROVING THE DATA BASE FOR REGULATORY DECISION-MAKING
A recurring theme in 5. 1074 is the need to improve the data bases underlying
EPA's pesticide tolerance decisions. Here, too, we are in agreement on the funda-
mental principles: we do need better data, especially as we continue to consider pop-
ulation subgroups in performing our analyses of potential pesticide risks. When we
turn to considerations of practical implementation, however, the specific provisions
of S. 1074 raise some concerns.
We need to focus on the issue of what data can reasonably be expected to be ob-
tained and what incremental benefits can reasonably be anticipated from their use.
As currently drafted, for example, 5. 1074 contains provisions that require EPA to
have "reliable, statistically significant data regarding the dietary exposure to per-
sons who have consumed the food for which the tolerance for the residue is pro-
posed or is in effect," at a minimum for each of a number of age groups listed in the
bill. If there are too few observations in any category of consumers (say, squash
eaters aged 1-2 years) to qualify as "reliable, statistically significant data," then ap-
parently no tolerances could be set for any pesticide on that food.
EPA's current practice is to use the ORES to assess potential exposure to the pop-
ulation as a whole as well as appropriate subgroups. ORES currently allows us to
look at over 20 subgroups as well as the general population when considering toler-
ance decisions. The data in DRES are drawn from the Nationwide Food Consump-
tion Survey conducted by USDA, and include approximately 88,000 data points,
based on a one-day recall and 2-day food diary survey of 30,770 respondents. Even
with this data base, some foods may not be eaten frequently enough by enough re-
spondents in a given subgroup to meet a rigorous test of "statistical significance" of
representativeness.
EPA should have the flexibility to make reasonable "default" assumptions about
exposure when necessary. 5. 1074 as introduced would not allow EPA to use avail-
able data and reasonable default assumptions.
We are particularly concerned about the possible impact of these provisions on
the ability of growers to produce fruits and vegetables. Fruits and vegetables gener-
ally represent relatively "minor uses" of pesticides. Already, pesticide manufactur-
ers have abandoned a number of these minor uses, rather than generate the data
PAGENO="0053"
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EPA is requiring as part of our reassessment of older pesticides under amendments
to FIFRA enacted in 1988. The cost of data generation do not appear justified to the
registrant in terms of expected revenues from pesticide sales for minor uses. Enact-
ment of legislation that imposes significant new data requirements could exacerbate
the minor use problem, at a time when health authorities are urging Americans to
increase their consumption of many of these foods.
In summary, while we agree that improvements to DRES are needed, EPA does
not believe that all of the new data requirements in S. 1074 are justified, when rea-
sonable default assumptions will protect the public health. We have undertaken de-
velopment of a number of DRES enhancements; for example, we are developing the
capability to estimate the standard error of the mean consumption, which will help
us evaluate when there are too few data points in the food consumption survey to
make a reliable estimate of exposure. We will continue to work to develop sound
approaches that will enhance our data bases.
UNIFORMITY OF TOLERANCES
S. 1074 fails to establish national uniformity for pesticide tolerances. Without
such a provision, states could set tolerances for pesticide residues in food that vary
from those established by EPA, regardless of whether there were sound environ-
mental or public health reasons for the differences. This situation creates the poten-
tial for considerable consumer confusion and disruption of interstate commerce in
food products, if our food distribution and marketing systems must cope with a
patchwork of inconsistent state-by-state requirements. Inconsistent tolerances could
also complicate international trade in raw agricultural commodities and processed
food.
The Administration has proposed that national uniformity be established by stat-
ute on a strictly prospective basis, for tolerances that are set as a result of EPA's
ongoing reregistration efforts, and for new pesticide tolerances established based on
complete data and in accordance with the updated standards for tolerance setting
that we have proposed. Under our proposals, there would be a presumption in favor
of uniformity, but states would still be able to obtain waivers and establish their
own tolerances if special local circumstances exist. In addition, EPA would have the
option of revising the national tolerances on the basis of a State's proposal for more
stringent limitations, thus enhancing food safety for all Americans.
OTHER PROVISIONS
I would like to comment briefly on certain other issues raised by the bill.
First, we believe the deadlines and requirements imposed by 5. 1074 may raise
resource concerns for EPA that are not fully alleviated by the inclusion of a fee pro-
vision. As you know, under the FIFRA amendments passed by Congress in 1988, we
are requiring up-to-date data and reevaluating all of the older pesticides first regis-
tered before many of our current scientific data requirements were in effect. FIFRA
`88 placed this reregistration program on a series of strict deadlines. We appreciate
the fact that 5. 1074's deadline provisions are much closer to the FIFRA `88 sched-
ule than the comparable provisions of previous food safety bills. As we have testified
before the House Agriculture Committee, however, resource constraints threaten
EPA's ability to meet the FIFRA `88 deadlines. Moreover, S. 1074 would greatly
expand the number of chemicals subject to review by adding inert ingredients and
newer food use active ingredients.
Second, the bill contains a new provision that would shift the burden of proof in
certain judicial proceedings to EPA. It is not completely clear what this change is
intended to accomplish. Under existing law, of course, EPA decisions are already
subject to judicial review. The proposedchange appears out of step with long-stand-
ing principles governing judicial review of regulatory decisions based on complex
scientific data, and we believe it is not appropriate in this case.
Finally, we support a variety of provisions of the bill which clarify the Agency's
authority in several areas and which provide a more efficient administrative process
for tolerance-setting. For example, the bill provides explicit statutory authority for
EPA to set expiration dates for tolerances; to require data; to reevaluate existing
tolerances and exemptions; to demand practical methods of residue analysis; to col-
lect fees for the maintenance of tolerances; and to allow food containing residues
from legal uses of pesticides to clear the channels of trade after a tolerance has
been reduced or revoked.
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THE ADMINISTRATION'S FOOD SAFETY PLAN
I'd like to turn now to a brief discussion of the Administration's Food Safety Plan,
as developed and submitted to the Congress during the last session.
Two of our key goals in the food safety plan are to bring FIFRA and the FFDCA
into greater harmony and to enhance our ability to take prompt, effective action
when we find that a pesticide poses unreasonable risk. For these reasons, we believe
it is imperative that we work to amend both statutes.
I have already covered our two major FFDCA proposals. First, we support enact-
ment of legislation that would establish a single, protective standard for the estab-
lishment of tolerances for pesticide residues in foods, eliminating the obsolete De-
laney clause standard and introducing the concept of negligible risk in a way that
will permit future advances in our scientific understanding to be reflected in our
regulatory policies. EPA would assess both risks and benefits in making tolerance
decisions under the FFDCA and registration decisions under FIFRA. We also pro-
posed to amend FFDCA to establish, prospectively, national uniformity for toler-
ances that EPA sets or reaffirms based on a complete data set, pre-empting incon-
sistent State standards except where a waiver is justified based on special local cir-
cumstances.
Our proposed FIFRA changes would enable EPA to use its suspension authority
more effectively when the data warrant immediate suspension of pesticide use;
streamline the time-consuming cancellation process; establish the principle of peri-
odic review of pesticides to ensure that the data supporting registration are regular-
ly reviewed against current scientific standards; strengthen our enforcement au-
thorities; and increase penalties for FIFRA violations. Finally, the Administration
plan provides for enhanced interagency consultation among EPA, USDA, and HHS
on pesticide, public health, and food safety issues.
The Administration continues to support enactment of food safety legislation that
addresses each of these points. We recognize that the approach we have outlined,
amending both FIFRA and FFDCA, complicates consideration in a jurisdictional
sense, but we urge you and your colleagues on the Agriculture Committee to join
with the Administration in working toward comprehensive legislation.
CONCLUSION
EPA supports enactment of strong food safety legislation that will update and up-
grade our authorities under both FFDCA and FIFRA. We cannot, however, support
enactment of 5. 1074 as currently drafted.
Taken together, the provisions of 5. 1074 significantly restrict flexibility in using
the best available scientific data and information in regulatory decision-making, and
may inhibit scientific progress. The net effect of eliminating all benefits consider-
ations and compounding the many conservative assumptions required by the bill
would produce an unnecessarily stringent system of regulation. In that sense, its
actual implementation may in fact be more stringent than under current law with
the Delaney Clause. Many important pesticide uses could be lost, for no meaningful'
public health gain.
For these reasons, we urge that 5. 1074 in its current form not be enacted. We
stand ready to work with you toward the development and passage of food safety
legislation that addresses the important issues I have outlined in a more workable
and effective way. Building on some of the themes contained in your legislation, as
well as the key points of the Administration's food safety plan, we can act together
to make significant improvements in our current system of pesticide regulation.
This concludes my statement Mr. Chairman, I would be pleased to answer any
questions that you or the other members of the committee may have.
Senator SIMON [presiding.] Thank you.
Fred Shank, director of the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration. We are pleased to
have you here, Mr. Shank.
Mr. SHANK. Good morning, Senator.
I appreciate the opportunity to testify today on 5. 1074, the
"Safety of Pesticides in Food Act of 1991".
FDA has long been a leader in food safety. We have been in the
forefront in making estimates of exposure and using contemporary
PAGENO="0055"
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scientific knowledge to assess the risk of chemicals added intention-
ally or inadvertently to foods.
For many years, we have collected data on the incidence and
levels of residues. The high quality and consistency of our analyti-
cal results as well as the sensitivity of our analytical methods in
detecting and measuring residues in the parts per billion range are
recognized worldwide.
We are further strengthening our pesticide program in line with
the "Pesticide Monitoring and Improvements Act of 1988". We be-
lieve the committee has in S. 1074 identified several of the areas in
the regulation of pesticide residues that are in greatest need of
reform, such as the application of a negligible risk standard to the
pesticide residues in both raw and processed foods.
This and other issues were part of the administration's food
safety plan announced by President Bush in 1989.
While we applaud the opening of the food safety debate, in this
case, legislation pertaining to pesticide residues, we have serious
concerns about the impact of the legislation generally as well as
several concerns specific to FDA's program.
S. 1074 would update the statutory safety standard applicable to
carcinogens by applying the concept of negligible risk to pesticide
residues on both raw agricultural commodities and processed foods.
And we support the use of this concept as the basis for establish-
ment of pesticide residue tolerances, but we believe that there are
serious drawbacks to the bill's highly prescriptive, very conserva-
tive approach and procedure for risk assessments. My written re-
marks elaborate on these issues.
We are also concerned that S. 1074 would require FDA to concen-
trate the bulk of its monitoring effort and existing resources on rel-
atively few chemicals. The bill seems to suggest that pesticides for
which tolerances have been established pose the greatest public
health risk and thus warrant the greatest monitoring effort. Our
monitoring data over the years have shown that tolerances are
rarely exceeded. Indeed, the vast majority of the illegal pesticide
residues that we detect each year involve the pesticide residue-food
combinations for which a tolerance has not been established.
Residue data generated by the States and collected into an FDA-
funded database show very much the same thing, that is, very few
residues exceed the tolerances.
We are also concerned that S. 1074 would appear to give lower
priority to monitoring of residues resulting from misuse and moni-
toring for pesticides that are used in other countries, but not in the
U.S. Indeed, we agree that food safety law reform with respect to
pesticides is warranted. Further, we join EPA and USDA in the
belief that rational, comprehensive food safety reform requires
amendments of both the Food, Drug and Cosmetics Act and FIFRA.
However, in accomplishing the reform, flexibility must be pre-
served for the regulatory agencies to use the latest scientific knowl-
edge and judgment in arriving at food safety decisions. In other
words, we urge that legislation outline the framework, but not pre-
scribe a recipe for food safety.
We stand ready to work with committee staff to develop effec-
tive, workable legislation that will bring our pesticide laws into
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line with the current science and provide a framework for continu-
ing progress in the future.
Senator, we commend the committee for opening the discussion
on these vital issues and thank you for affording us this opportuni-
ty to testify.
[The prepared statement of Mr. Shank follows:]
PREPARED STATEMENT OF FRED R. SHANK, PH.D.
Mr. Chairman, I appreciate the opportunity to testify today on 5. 1074, the
"Safety of Pesticides in Food Act of 1991." This legislation would revise the author-
ity of the Environmental Protection Agency (EPA) under the Federal Food, Drug,
and Cosmetic Act (FDC Act) to regulate pesticide residues in food. The bill would
also have both a direct and an indirect impact on the programs of the Food and
Drug Administration (FDA).
EPA, FDA, and USDA share responsibility for the Federal regulation of pesticides
used on food or feed. EPA registers pesticides for use and establishes tolerances,
which are the maximum amounts of residues that may legally remain in or on a
food when a pesticide chemical is used according to label directions. FDA enforces
compliance with EPA's tolerances by sampling and analyzing both domestic and im-
ported food to determine whether any pesticide residues remaining in or on the food
conform with established limits. USDA carries out this function for meat and poul-
try products.
FDA has watched closely and participated in the debate on regulation of pesti-
cides that has occurred over the past several years in Congress as well as in the
public arena. Moreover, FDA has long been involved in the broader issues of food
safety. Indeed, although we agree that food safety law reform with respect to pesti-
cides is warranted, we caution that this effort not divert attention from other food
safety problems, such as microbiological hazards, which equal or exceed the risks
posed by pesticide residues.
This debate over regulation of pesticides has generated a wide range of proposed
revisions to food safety law, but also has highlighted some areas of general agree-
ment. For example, there is agreement about the need to streamline the process for
taking regulatory action against pesticide registrations and associated tolerances for
pesticides about which serious safety considerations have arisen, and for harmoniza-
tion of discrepancies in current law.
As you may recall, in October 1989, President Bush urged that changes to food
safety law include improvements to enhance EPA's authority to suspend pesticide
use; streamline cancellation procedures; establish periodic review of pesticide regis-
trations; increase consultation among the agencies having responsibility for regulat-
ir~g pesticides; strengthen EPA's enforcement authorities; eliminate inconsistent
standards for pesticide residues in raw and processed foods through implementation
of a "negligible risk standard;" and establish prospectively, national uniformity for
pesticide tolerances. 5. 1074 also addresses several of these points.
FDA is keenly aware that absolute safety can never be guaranteed. The role of
Federal agencies must be to assure that agricultural pesticides pose no unreason-
able risks, to set protective limits for pesticide residues, and to enforce these limits.
Through proper risk assessment and risk management, risks can be reduced to in-
significant or "negligible" levels.
We, therefore, believe that any changes to the existing statutory framework for
pesticide regulation should be consistent with current scientific principles and
public health goals, be flexible enough to allow regulatory decisions to reflect ad-
vances in scientific understanding, and be enforceable. The latter can be accom-
pushed only if Federal regulatory agencies are provided with adequate tools to do
the job.
We have serious concerns about the impact of the legislation generally, as well as
several concerns specific to FDA's programs.
NEGLIGIBLE RISK
As you know, under the current law, pesticides which are applied to or concen-
trate in processed foods are subject to the Delaney clause in section 409 of the FDC
Act, while pesticide residues in raw agricultural commodities are subject to a risk!
benefit determination under section 408. The Delaney clause, read literally, requires
absolute safety and would prevent the establishment of any tolerance for a residue
in a processed food of any pesticide that is a human or animal carcinogen.
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At the time the Food Additive Amendments were enacted (1958), the Delaney
clause, literally interpreted, was consistent with the scientific knowledge and tech-
nology of the day: the number of known or postulated carcinogens was fairly small,
and the then state-of-the-art capability to detect a substance at a level of a few parts
per million was considered ultrasensitive. As testing methods have become more so-
phisticated, however, it has become abundantly clear that a new approach for ad-
dressing risk is needed. Increasingly sensitive analytical methods allow detection of
substances at the level of parts per trillion.
An appropriate negligible risk approach allows these scientific advances to be
taken into account. FDA is quite familiar with this type of approach, as we use or
have proposed its use in a number of cases. For instance, advances in risk assess-
ment enable scientists to conclude that some substances shown to be carcinogens in
high-dose animal studies represent no risk to human health when present in minute
quantities in the food supply under specified conditions of use of the substances.
This conclusion was also reached by the National Academy of Sciences in its 1987
report, Regulating Pesticides in Foods: the Delaney Paradox.
5. 1074 defines "negligible risk" as a reasonable certainty that "no harm to
human health" will be caused by exposure to a pesticide chemical residue, thus rec-
ognizing the need to update the statutory safety standard applicable to carcinogens
by applying this concept to pesticide residues. The bill also addresses the need for a
consistent standard for regulating pesticide residues in both raw agricultural com-
modities and processed foods by applying negligible risk to all pesticide residues.
While we support the use of this concept as the basis f~or establishment of pesticide
residue tolerances, we believe there are serious drawbacks to the bill's highly pre-
scriptive definitions of "negligible risk."
The bill differentiates between pesticide residues for which EPA can identify a
lavel at which the pesticide will not cause or contribute to any known or anticipated
harm to human health ("threshold" pesticides), and "non-threshold" substances, for
which such a level cannot be identified. All carcinogens are placed into the latter
category regardless of their mechanism of action. We believe that this wholesale
treatment of all carcinogens as non-threshold substances is contrary to the evolving
scientific knowledge about carcinogens. We believe that for some carcinogenic pesti-
cide residues, a threshold may be identified, and that such threshold carcinogens
should be regulated like all other threshold chemicals.
Another issue that we would raise as a point of general concern is found in Sec-
tion 408(m) (2) (C), which would require EPA to have the burden of proof in any
judicial proceeding pertaining to tolerances, including revocation or denial of a tol-
erance. Currently, the FDC Act requires the proponent of a food additive petition or
the sponsor of a new drug to show that a food additive or drug is safe for its intend-
ed use. FDA's regulations for administrative hearings reflect this, in that the propo-
nent of safety is required to bear the burden of proof in any administrative proceed-
ing. We suggest that the provision be deleted.
BACKGROUND ON FDA'S PESTICIDE PROGRAM
Before discussing the rest of our concerns about the bill with respect to FDA's
existing program, some general background on FDA's pesticide residue monitoring
program and strategy might be helpful.
Over 300 pesticides have tolerances for use on food crops in the United States,
and an additional 200-300 pesticides may be used in foreign countries. Over 100
countries export foods to the United States annually, and crops are produced in all
50 states and in U.S. territories each year. The challenge for FDA is to seJect from
this universe of literally hundreds of thousands of possible pesticide/commodity/lo-
cation combinations those which should be given priority.
The agency has developed a sampling strategy to focus its resources as efficiently,
comprehensively and cost-effectively as possible. In general, the agency emphasizes
commodities that have relatively high dietary importance, for example, potatoes
rather than artichokes because potatoes are consumed in much greater amounts.
FDA also considers factors such as the toxicity of a pesticide and its metabolites and
degradation products, volume of usage, the types of crops likely to be treated, prior
residue findings and violations, and state monitoring programs.
FDA routinely cooperates with EPA and includes in its sampling program chemi-
cals identified by EPA as being of special interest. For example, FDA provides EPA
with monitoring data for pesticides undergoing "Special Review," initiated when
new evidence suggests that use of the pesticide may present a previously unrecog-
nized risk.
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While we are certainly aware of the need and desirability of continuing coopera-
tion with EPA, we stress that FDA needs regulatory flexibility to determine the
most appropriate sampling strategies, direct our pesticide monitoring resources in
the most cost-effective, efficient manner possible, and still be able to respond in a
timely fashion to specific concerns or issues that arise. The basis for sampling as set
forth by 5. 1074 could preclude this.
Section 408(k) of 5. 1074 would require FDA to give priority to foods containing
residues identified by EPA as either above the negligible risk standard, or "which
may under certain circumstances reach or exceed such standard."
We are concerned with the potentially significant impact this might have on the
agency's monitoring resources. Strict FDA compliance with the wording of the bill
could have FDA concentrating the bulk of its monitoring effort and existing re-
sources on relatively few chemicals.
This provision also seems to suggest that certain pesticides for which tolerances
have been established pose the greatest public health risk, and thus warrant the
greatest monitoring effort. Our monitoring data over the years have shown that tol-
erances are rarely exceeded. The vast majority of the illegal pesticide residues we
detect each year involve pesticide residue/food combinations for which no tolerance
has been established. We are concerned that this provision appears to give lower
priority to monitoring for residues resulting from misuse and monitoring for pesti-
cides that are used in other countries but not in the United States. We therefore
question whether the monitoring priorities in the proposed bill will enhance con-
sumer protection. We also respectfully note that Congress, the General Accounting
Off ice, and others have repeatedly urged FDA to expand its sampling of imported
foods. The bill's monitoring provisions appear to contradict this goal.
EXPOSURE DATA
Several sections of 5. 1074 refer to "statistically significant data" with regard to
estimating dietary exposure to pesticide residues. Section 408(b)(2)(E) identifies nine
population groups (primarily children) for which such data are expected to be avail-
able and used by EPA in evaluating risk. While we support the intent of the bill to
prevent children from bearing a disproportionate risk from exposure to residues, we
question the codification of the divisions in the groups identified in the bill. Agen-
cies need flexibility to define food consumption groupings based on valid scientific
criteria.
We further question whether data regarding the food consumption patterns of
groups with "special consumption patterns" are available. Given the wide range of
potential diets for extant ethnic populations, vegetarians, etc., the task of evaluating
dietary exposure for all these potential populations, even if the data were available,
takes on monumental proportions.
METHODS OF ANALYSIS
FDA supports the concept of formal consultation with EPA to assure that an ana-
lytical method suitable for enforcement exists before a pesticide tolerance is estab-
lished or allowed to remain in effect. FDA and EPA have for many years consulted
on analytical methods and maintain an interagency task group, which includes rep-
resentatives from USDA, for the regular exchange of information about analytical
methodology. FDA agrees with the bill's proposal that analytical methods be consid-
ered early on in the tolerance setting process, and that multiresidue methods be em-
phasized.
We note, however, that the bill does not require EPA consultation with FDA
when a method is identified under the "Special Rule" or when an analytical method
is reevaluated. We see no reason for absence of consultation in the "Special Rule"
situation and during the reevaluation of a method. We believe that the same level
of consultation is necessary in any situation involving an analytical method that
FDA may use in its enforcement program.
We are also concerned that the "Special Rule" could potentially force upon the
agency an inappropriate, albeit the most sensitive, analytical method, regardless of
that method's cost, complexity, or validity. The acceptability of a method should not
be based solely on its sensitivity use. Moreover, the "Special Rule" provision, as
written, requires only that a method detect a residue. FDA needs analytical meth-
ods capable of both detection and measurement to enforce tolerances and monitor
the incidence and levels of pesticide residues.
We are also concerned that the consultation contemplated in the bill will compel
FDA to conduct laboratory trials of methods.
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FEES
The bill authorizes EPA to impose and collect fees related to registering and es-
tablishing tolerances for pesticides. We believe this authorization should be expand-
ed to include the costs of the additional activities required of FDA under this bill.
For example, as mentioned previously, S. 1074 would require FDA to perform moni-
toring over and above the Agency's regulatory program to determine if residues are
in compliance, and also to evaluate the suitability of analytical methods. To carry
out additional sampling and analyses and evaluate analytical methods without af-
fecting the current program would require additional resources. We believe the
costs of these additional activities should be covered by user fees.
CONCLUSION
In sum, we believe that S. 1074's incorporation of the concept of negligible risk to
be a significant first step toward updating the law to reflect changes in scientific
knowledge and methodologies. Rational food safety law reform is warranted in light
of what we now know about chronic exposure to chemicals and the progress science
has made since the Delaney clause was first enacted.
As currently written, however, we oppose enactment of S. 1074 because of the con-
cerns outlined by the administration at this hearing. Nevertheless, the administra-
tion is ready to work with committee staff to discuss ways in which our concerns
might be resolved.
Mr. Chairman, we commend the committee for opening the discussion on these
vital issues, and thank you for affording us this opportunity to testify. I would be
pleased to answer any questions that you or members of the committee have.
Senator SIMON. Thank you, Mr. Shank.
Next, Daniel D. Haley, administrator of the Agricultural Market-
ing Service at the Department of Agriculture.
Mr. HALEY. Good morning, Senator Simon and other members of
the committee. I welcome the opportunity also to be with you today
to present the department's views for legislative reform for our
food safety laws concerning pesticides and to discuss how this
reform will affect American agriculture.
My testimony will focus on certain key provisions in S.1074
which the department feels could cause dietary hardships and eco-
nomic burdens for our consumers and our producers.
The judicious application of pesticides plays an important role in
providing the safest, most abundant and affordable food supply of
any place in the world-in fact, we are the envy of the world. Our
shared goals are to ensure public health and environmental protec-
tion and maintain confidence in the safety of the food supply.
Obviously, the way we achieve that goal differs dramatically.
The food safety plan announced by President Bush 2 years ago is
a comprehensive package of reforms that taken together will mark
a major step forward in public health and environmental protec-
tion.
In the interest of time let me just reiterate what my colleagues
have said and, consistent with the President's plan, say that we
support national uniformity of tolerances prospectively; we support
a single pesticide tolerance for both raw and processed foods, ac-
cording to the NAS recommendation, and we support the concept
of a negligible risk standard.
It should be made clear, however, that EPA can establish a toler-
ance for a pesticide residue posing greater than a negligible risk if
EPA determines that the tolerance is protective of the public
health-and I stress that again-protective of the public health-
and that the risk is reasonable.
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Consideration of pesticide benefits is, as you know, of major im-
portance to the Department of Agriculture. Pesticides provide im-
portant societal benefits to consumers and producers. These are
health benefits. These benefits are nutritional. And yes, these bene-
fits are economic.
The loss of important food use pesticides can result in heightened
risk of disease-causing organisms in food such as fungus, molds and
bacteria; they can result in food price increases, adverse effects on
food quality, and reduction in the availability of nutritional food
choices.
I want to emphasize that these benefits should be considered.
They should not drive the process. They should not overwhelm the
process. But they need to be considered.
In the short time I have left, let me just take a moment and
highlight an extremely important area, and that is the problems
associated with pesticides for minor use crops. As a result of re-reg-
istration, many registrants who respond to the increased cost of
testing and tight deadlines have canceled pesticides for numerous
fruit and vegetable crops-literally thousands. These include live-
stock and grain uses as well. Many more uses are expected to be
dropped in the near future. USDA and EPA have recognized that
much needs to be done if agricultural producers are to deal success-
fully with the consequences of re-registration. Unfortunately, we
feel that S. 1074 would exacerbate what already promises to be a
train wreck for American agriculture if we don't get a handle on
this.
Overall, to summarize, our concerns are basically threefold. This
bill would eliminate the current system of balancing benefits of
pesticides against the risks they pose to society. It would establish
an unnecessarily prescriptive method of calculating negligible
risks, and it would remove the flexibility to look at real residues,
real exposures, and constantly react to the science in that area.
We must remember the scientific community has reiterated time
and time again that minuscule amounts of pesticides in our food
supply is not a problem. In addition, pesticide residues generally do
not exceed tolerances according to the Food and Drug Administra-
tion or the National Research Council-in fact, just the opposite.
I'd like to take a moment if I could, Senator, to respond to sever-
al things that were discussed by the previous two witnesses. I think
they said on half a dozen occasions we don't have a statistically-
based information database on residues. Last year, this Congress
authorized a program that we in agriculture are implementing as
we speak. We are taking samples right now, not the enforcement
modes of the States and FDA, but a comprehensive, statistically
based sampling of those residues across this country.
We have six States that we have cooperative agreements with.
We are doing it on 105 pesticide combinations. So I think we are in
the process of getting that database that was said does not exist.
Another thing that was raised was that there are 105 uses for
apples and 110 for citrus. That's a very good point. The fact of the
matter is any given grower might use two or three or five of them,
not 105 of them. And should we be regulating on what they use or
the theoretical maximums that we must revert to that every, single
one of those are used on an orange crop at the maximum tolerance
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and consumed for 70 years. That's the kind of reality we hope to
bring to the process.
One more thing in the written testimony that was raised here by
Dr. Jackson, who stated that there were some 1,000 illnesses from
aldicarb, confirmed illnesses. Well, I was the department official in
the California State department of agriculture when that case was
put to rest. I was in charge of the litigation and the settlement in
that case, and nowhere did we ever have 1,000 confirmed illnesses
of aldicarb. So I wanted to make that clear for the record.
In conclusion, the department does not support the prescriptive
standards of 5. 1074. We agree that the Federal laws on food safety
and pesticide use need to be revamped so as not to severely impact
the credibility of the current system and the new scientific and
technological breakthroughs in the chemical industry. It is impera-
tive that we proceed in a responsible manner and not jeopardize
the Nation's agricultural industry, which represents some 20 per-
cent of our GNP.
We urge the committee in its deliberations to consider the ad-
verse impacts of 5. 1074 on American agriculture and the consum-
ing public.
Thank you, Mr. Chairman. That concludes my verbal statement.
[The prepared statement of Mr. Haley follows:]
PREPARED STATEMENT OF DANIEL D. HALEY
Good morning, Mr. Chairman and Members of the Subcommittee. I welcome the
opportunity to be with you today to present the Department's views for legislative
reform of our food safety laws concerning pesticides and to discuss how this reform
will affect American agriculture. I am accompanied today by Dr. Craig Reed, Direc-
tor of the Science Division, Agricultural Marketing Service.
My testimony will focus on certain key provisions in S. 1074 which the Depart-
ment feels could cause dietary hardships and economic burdens for our consumers
through the denial of the beneficial use of pesticide tools and lost productivity to
our Nation's producers. We believe the impacts which would result from S. 1074 out-
weigh any potential health benefits from the legislation.
The U.S. food supply is the safest, most abundant, and most affordable anywhere
in the world. The judicious application of pesticides plays an important role in pro-
viding this food supply. We fully recognize the importance of continuing to strive to
do an even better, more effective job of evaluating potential risks from pesticides,
and reducing those risks. The Administration shares your goals to ensure public
health and environmental protection and to maintain and enhance public confi-
dence in the safety of the food supply. This means we must make regulatory deci-
sions based on the best state-of-the-art science we can bring to bear, through a proc-
ess and within a time frame that respects the interests and the expectations of all
concerned parties, including consumers and farmers.
The Food Safety Plan announced by the President 2 years ago is a comprehensive
package of reforms that, taken together, will mark a major step forward in public
health and environmental protection. Enactment of the plan will allow EPA to act
more promptly and effectively, based on sound science, to deal with problem chemi-
cals and establish a credible system of pesticide regulation.
The President's plan called for:
1. Establishing "negligible risk" tolerance levels which would be applicable to raw
commodities as well as processed foods, moving away from the "zero" risk standard
of the Delaney clause;
2. Establishing prospectively national uniform pesticide tolerance standards to
maximize the efficiency and effectiveness of our domestic and global markets;
3. Requiring periodic review of pesticide registrations to ensure pesticides contin-
ue to meet contemporary standards for health and safety;
4. Improving EPA's flexibility in exercising its suspension authority;
5. Revising the cancellation process, replacing the adjudicatory hearing with
notice-and-comment procedures;
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6. Enhancing the enforcement provisions of Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), providing for improved authorities and increased penalties
for violations; and
7. Providing for early and appropriate coordination and consultation among Envi-
ronmental Protection Agency (EPA), U.S. Department of Agriculture (USDA) and
Health and Human Services (HHS) in the pesticide cancellation and suspension
process.
KEY PROVISIONS
Single Pesticide Tolerance Standard. USDA supports legislation that would
amend the Federal Food, Drug and Cosmetic Act (FFDCA) to make the same safety
standard applicable to pesticide residues in both raw agricultural commodities and
processed food.
Under current law, there are two different legal standards for pesticide residues
in food. Tolerances for pesticide residues in raw agricultural commodities are sub-
ject to risk/benefit determinations under Section 408 of FFDCA. Tolerances for pes-
ticide residues that concentrate in, or are applied to, processed food are issued
under Section 409 of the FFDCA, which contains the Delaney clause which if literal-
ly interpreted would mean a "zero risk" standard.
In 1987, the National Academy of Sciences (HAS) recommended that pesticide res-
idues in raw and processed food should be regulated on the basis of consistent stand-
ards and that a negligible risk standard should apply to all pesticide residues in
food. Consistent with the HAS recommendations, this Administration supports
elimination of application of the Section 409 "Delaney Clause" to pesticide residues
in processed food and supports a uniform negligible risk standard for all pesticide
residues in food.
Negligible Risk Standard. USDA supports a negligible risk standard that would
require EPA to set pesticide tolerances at a level adequate to protect the public
health and the environment.
We support legislation that would implement the NAS recommendation for a uni-
form negligible risk standard for pesticide residues in food and, in addition, clearly
establish a risk/benefit standard. This would give EPA explicit statutory authority
to ignore de minimis or insignificant dietary risks and permit the Agency to focus
attention on the highest risk pesticides.
The definition of "negligible risk" should not identify a specific level of risk that
would be considered negligible or a numerical expression of that level. Because sci-
ence and the degree of knowledge and confidence in risk assessment is constantly
evolving and improving, it is important to preserve EPA's ability to keep pace with
the evolving science of risk assessment.
Contrary to the requirements in S. 1074, EPA should continue to have the flexibil-
ity to calculate dietary exposure on the basis of the (1) percent of raw agricultural
commodities or processed food actually treated with a pesticide, and (2) other data to
more closely approximate actual exposure, including information on actual residue
levels detected in the treated commodities and the processed food produced from
those commodities. This would help avoid unrealistic exposure assessments and
would assist in developing more accurate risk projections.
Consideration of Pesticide Benefits. It should be made clear that EPA may estab-
lish a tolerance for a pesticide residue posing greater than a negligible risk if EPA
determines that the tolerance is protective of public health, and the risk is reasona-
ble in light of both risks, societal benefits, and that reasonable efforts are made to
develop alternatives.
This would assure, as is the case for most tolerance determinations, that pesticide
tolerance decisions are not made in isolation, and that EPA may fully consider all
relevant factors. In this manner, EPA will be able to set reasonable priorities and
use its resources to regulate the pesticides with unacceptable risks.
USDA provides information to EPA on the necessity of the use of the chemical for
the production of an adequate, wholesome and economical food supply. EPA then
considers this information in making tolerance decisions for pesticide residues on
raw agricultural commodities. The President's plan would extend that authority to
tolerance decisions for pesticide residues on processed food. EPA is currently pre-
cluded from taking into account the benefits of pesticides that are applied to or that
concentrate in processed food.
Pesticides provide important societal benefits to consumers and producers, e.g.,
health, nutritional, economic. The loss of important food use pesticides can result in
heightened risk of disease causing organisms in food, food price increases, adverse
effects on food quality and reduction in the availability of nutritional food choices.
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The impact on consumers and their diet can cause particular hardship on the low
income sector of our society. In view of the broad range of benefits of food use pesti-
cides, it is important that EPA balance benefits against risks in all pesticide toler-
ance decisions.
Pesticide Data Program. USDA's Pesticide Data Program (PDP) will improve
upon the quality and quantity of food safety information that exists by gathering
more information on actual pesticide residue levels in foods. The actual residue data
will be provided to EPA for use in conducting risk analysis and in setting pesticide
tolerances.
The PDP will use statistically-based product sampling to permit inferences to be
made about the larger "population" of products. The sampling process is crucial to
obtaining an objective "picture" of pesticide residues and other toxic substances in
food.
The pesticide use data collected by the National Agricultural Statistics Service
(NASS) compliments the data on pesticide residues collected by USDA's Agricultur-
al Marketing Service (AMS). The NASS data will also assist in identifying pesticide
commodity pairs for residue sampling and in devising risk reducing strategies for
pest control produced by the Economic Research Service.
National Tolerance Uniformity. Under current law, States may set tolerances for
pesticide residues in foods that are lower than those established by EPA. In recent
years, a number of States have set lower tolerances for certain pesticides (including
EBDC and Alar), creating significant burdens on interstate commerce. We support
legislation that sets national uniformity of tolerances for pesticides registered or
reregistered under the comprehensive safety data requirements adopted by EPA in
1985. This uniformity would avoid the consumer confusion and substantial burdens
on interstate commerce caused by special tolerance requirements set by States and
political subdivisions that may not be warranted by any public health or food safety
consideration. Consumer protection would be assured by limiting required uniformi-
ty to pesticide tolerances supported by current and complete scientific testing and
recent EPA approval.
We support a mechanism for States to petition the EPA for an exemption from a
uniform Federal tolerance where the State could establish adequate justification.
Exemptions should be authorized where EPA has concluded that a special State tol-
erance is justified by compelling local conditions, such as unusual food consumption
patterns.
Pass-through Provision. It is important that food safety legislation retain the pro-
vision of current law that if a tolerance or exemption is in effect for a pesticide
chemical in a raw agricultural commodity, a residue of that chemical in a processed
food made from the raw agricultural commodity shall not be considered unsafe as
long as the concentration of the residue in the processed food is not greater than the
tolerance prescribed for the agricultural commodity. This provision avoids the neces-
sity of establishing separate tolerances for pesticide residues in processed food and
provides recognition of the fact that the majority of pesticide residues do not concen-
trate in processed food. Where residues are found to concentrate or break down into
harmful metabolites, EPA should set tolerances for the processed food on the same
basis as on the raw commodities.
The Administration will work with Congress to develop sound legislative language
to deal with these issues.
5. 1074 would eliminate the current system of balancing the benefits of pesticides
against the risks they pose to society. It would establish an unnecessarily prescrip-
tive method of calculating aggregate negligible risks based on total food uses of a
pesticide and on total risks from all pesticides used on a specific crop. The effect
would be fewer pesticides available to producers, decreased production, and lower
farm income and higher consumer prices. The bill also poses significant risks to the
continued viability of U.S. agriculture and threatens to increase the costs to con-
sumers. Pesticide residues generally do not exceed tolerance levels according to the
Food and Drug Administration and the National Research Council.
Problems with Pesticides for Minor Use Crops. While the legislation attempts to
improve food safety, its value to consumers would be minimal. It could lead to addi-
tional burdens by eliminating a wide spectrum of essential crop protection products
for many minor use crops and threaten the continued availability of those crops.
This will be especially true for consumers of "minor crops," such as most fruits and
vegetables, and for producers who rely upon pesticides for which there is a limited
market.
.This situation is the result of a process by which EPA must reevaluate all existing
agricultural pesticides. Amendments passed by Congress in 1988 to the Federal In-
secticide, Fungicide, and Rodenticide Act set a series of deadlines for completing the
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reregistration process. Those amendments not only placed significant new require-
ments on EPA but required registrants to pay a significant portion of the reregistra-
tion costs.
The legislation in S. 1074 could compound the difficulty faced in reregistration ef-
forts for minor use pesticides by requiring extensive new data on food consumption
which could be difficult to obtain for food not widely consumed. In addition, the new
restrictive negligible risk standards and exposure assumptions could force the can-
cellation of uses without significant actual risks.
As a result, many registrants will respond to the increased cost of testing and
tight deadlines by reducing the number of pesticide uses they support for reregistra-
tion. Under the provisions of reregistration, registrants have the option of deleting
pesticide uses by voluntarily withdrawing registration of product uses that are not
economically desirable to maintain. In those cases, EPA has the responsibility to
cancel the registration for crop use.
Pesticide registrations already have been canceled for numerous fruit and vegeta-
ble crop uses. Often these cancellations are due to the cost of data requirements
rather than risk concerns. Many more uses are expected to be dropped in the near
future. USDA and EPA have recognized that much needs to be done if agricultural
producers are to deal successfully with the consequences of reregistration. We are
working aggressively with the chemical companies and producer groups to deal with
current and anticipated problems so that we may better identify and meet the needs
of minor use chemical customers.
CONCLUSION
While the department opposes the prescriptive standards of 5. 1074, we agree that
the Federal laws for food safety and pesticide use need to be revamped in a manner
that will not severely impair new scientific and technological breakthroughs in the
agricultural chemical industry. It is imperative that we proceed in a responsible
manner so as not to jeopardize this Nation's agricultural industry which represents
some 20 percent of our GNP. We urge the committee in its deliberations to consider
the adverse impacts of 5. 1074 on American agriculture and the consuming public.
Mr. Chairman, this concludes my statement. I will be glad to respond to any ques-
tions the committee may have. -
The CHAIRMAN [presiding.] Thank you very much. I apologize for
my brief absence.
Let me ask you, Ms. Fisher, why is it inappropriate to have a
- children's standard in the legislation?
Ms. FISHER. Senator, we believe that there should be additional
protections for children, and under our current system we do take
into account the fact that children eat more and eat more of cer-
tain foods per pound of body weight than adults do. So we think
our current process does take into account the fact that their
eating habits are not the same.
We have asked the National Academy of Sciences to advise us on
whether or not the process we use, even with those additional pro-
tections, is adequate enough-in other words, are we doing enough
to protect children-and I think based on the information we get
from that study we may be able to better assess both as an agency
and you as the legislative branch what additional protections need
to be taken.
Our concern with the standard in your bill is that we are not
sure of the scientific underpinning for it, and we're not sure wheth-
er or not it is in fact the right way to go or necessary.
The CHAIRMAN. Well, what exactly is your standard for the pro-
tection of children?
Ms. FISHER. Well, what we take into account--
The CHAIRMAN. Well, "take into account" are rather general
words. We all take into account various considerations. I am inter-
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61
ested specifically in what are the processes, procedures, the tests
that are followed with regard to children.
Ms. FISHER. OK. I'll even use any one of the charts up there.
When we do our mathematical calculations to determine what the
exposure is of children, we look at their consumption factors, which
I think Dr. Wargo shows as much higher in the first few years. He
has broken it down into individual years. We have age grouping of
infants, children one to 6, so we are not quite as precise as he is.
But in our mathematical calculation we do take into account the
higher consumption factors that he has shown on his charts there
for categories of ages, not individual years.
We have used categories because as he correctly pointed out,
that's what we have the data for. We do not have very precise data
to look at consumption on a year by year basis as he has laid out.
The CHAIRMAN. Is your database the same one that he referred
to as going back to the 1970's?
Ms. FISHER. That's correct.
The CHAIRMAN. Has there been any attempt to upgrade it?
Ms. FISHER. There was an attempt. USDA did try to update it in
the late 1980's. There was a survey that was done I believe in 1987
and 1988, but it has some significant flaws with it, and we have
worked with USDA to try to come up with improvements to sur-
veys over the next couple years. So we are in the process of trying
to improve our database, but there are definitely flaws in the most
recent data.
The CHAIRMAN. Could you tell us how many tolerances are cur-
rently in existence that have been established or revised specifical-
ly on the basis of data on children's exposures?
Ms. FISHER. Senator, I don't have a number right offhand that I
can give you that shows numbers of tolerances that have been re-
vised lately. When we do review a pesticide and take a regulatory
action on it--
The CHAIRMAN. Well how many-are we talking about a dozen,
or 100--
Ms. FISHER. There are thousands of tolerances on the book. All of
those will be revised as we review each of the chemicals under our
FIFRA 1988 procedure.
The CHAIRMAN. My specific question is what has been revised on
the basis of data on children's exposures. You have indicated you
consider the' unique sensitivities of children, and I think there is a
fair point to be raised about micromanagement and over-regulation
by establishing precise formulas and mathematical formulas, and
you have indicated that you think it can be much better done by
just taking into consideration some of these matters and demon-
strating sensitivity to them. I'm just asking you if you could tell us
about any tolerances that are currently in existence that have been
established or revised specifically on the basis of children's expo-
sures.
Ms. FISHER. Our computer system that takes this kind of infor-
mation into account is relatively new; I think it has only been up
and running for the past couple years, so the number is rather
small. I would have to provide for the record what the exact count
is.
47-693 0 - 91 - 3
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The CHAIRMAN. All right. Couldn't many of your concerns about
the collection of data in children be resolved by having registrants
collect information which EPA could analyze?
Ms. FISHER. Yes. They could provide more information in terms
of the toxic effect. We have started to ask for more information on
the neurological problems caused by individual pesticides. Current-
ly the registrants do not give us consumption data, which might be
the issue that you are talking about. We rely on the USDA for the
consumption data.
The CHAIRMAN. Mr. Haley, from your own perspective, do you
think it is inappropriate to have a children's standard in the legis-
lation?
Mr. HALEY. I think we are all awaiting the NAS report which.
would point out the problems with children.
The CHAIRMAN. Are you prepared to support it if NAS recom-
mends it?
Mr. HALEY. If it is reasonable, no doubt in my mind we are will-
ing to adopt it. Mr. Chairman, I think this administration is as con-
cerned about children, and if children are more at risk in the food
supply, they deserve more protection. I don't think anyone is going
to deny that. I think the question comes at what level and to what
degree.
The CHAIRMAN. Given what you know about the increasing risk
for children, you are still going to leave it up to the Academy of
Sciences, and you are not prepared yourself, understanding what
you do understand in terms of the health needs of children, to
make any specific additional recommendations for their protection.
Mr. HALEY. We are working as we speak with EPA to develop
food consumption surveys that would incorporate subpopulations
including children, the elderly and others. So we are working on
that right now.
The CHAIRMAN. But you are not prepared to mention any of
them today.
Mr. HALEY. We do not have the results of those studies to make
those recommendations today.
The CHAIRMAN. And what studies are these?
Mr. HALEY. These are the food consumption surveys where we
actually look at food consumption around the country, and we are
in the process of--
The CHAIRMAN. Are you doing it specifically with regard to chil-
dren?
Mr. HALEY. I believe we are working directly right now on subpo-
pulations including children.
The CHAIRMAN. Do you have examples of those surveys that you
could submit now for the record?
Mr. HALEY. We do have some surveys that we could submit for
the record that we have done, food consumption surveys.
The CHAIRMAN. Do you have them here with you?
Mr. HALEY. No, we do not have them here.
The CHAIRMAN. Are these the 1987-'88 surveys?
Mr. HALEY. That's correct.
The CHAIRMAN. But you don't have anything following that. Are
you familiar with the GAO's evaluation of those studies?
Mr. HALEY. I am, Senator.
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The CHAIRMAN. What was it?
Mr. HALEY. They were critical of it and for a very good reason. I
think the GAO study points out that the study as a whole for the
general population was an accurate one, or one that we could rely
on. What they did is they said the response rate to the subpopula-
tions we used was inappropriate and not enough. We agree with
that, and that is the basis of my statement that we are currently
working with~ EPA to remedy that situation and deal with the rec-
ommendations of the GAO report.
The CHAIRMAN. What I am hearing from you is that you don't
like our program, that you are doing some additional reviews and
surveys, that they are basically the 1987 and 1988 surveys which
have been discounted by GAO, and that you are doing additional
studies as to how to reach the children's group-combined with the
statement that this administration is as interested as anybody else
in the problems of children. Well, I'll let the record stand on that
unless you want to give me an additional response, because that I
think is a pretty weak one.
Do you understand why we are troubled?
Mr. HALEY. I understand your point. Can we do better? The
answer is yes, we are in the process of doing just that.
The CHAIRMAN. No, I'm not satisfied with your point that we can
always do better. We can't always do better. What we're talking
about is a very special, identifiable, vulnerable group in our society
that have very special vulnerabilities in terms of tolerance levels,
and what the USDA is doing about it.
Mr. Shank, the FDA supports the bill's adoption of a negligible
risk standard but argues that the one in one million or any specific
standard is too restrictive and that there will always be a signifi-
cant possibility for better science in the future. But shouldn't we
adopt a clear standard now that will restore confidence in how pes-
ticides are regulated?
Mr. Shank. Mr. Chairman, yes, I think we should. And I don't
want to suggest that one in one million might not be an appropri-
ate standard. In the vast majority of cases, I think the one in one
million would be. But the prescriptive nature in which the risk as-
sessment is mandated within the bill is what we find most trouble-
some. It is a very conservative assessment that would probably
result in a standard that is much more severe than one in one mil-
lion as we currently know it.
The CHAIRMAN. Have you formed any position with regard to the
need for a children's standard for pesticide exposure?
Mr. SHANK. The Food and Drug Administration is looking for-
ward to the receipt of the National Academy of Science report. We
will consider the recommendations contained therein because we
too are concerned that we provide the appropriate standards for
the children of our Nation.
The CHAIRMAN. It is interesting that we can't make some judg-
ments about these matters. I think the Academy of Sciences, by
and large and in a wide range of different areas, has given us enor-
mously valuable and helpful information, but as we have heard,
many of those who are on that panel, who have spent most of their
professional lifetimes in these areas, have demonstrated the impor-
tance of developing that standard.
PAGENO="0068"
64
You are familiar with the 1986 GAO study that documented that
the routine, analytical method of FDA's monitoring program could
not monitor over 40. percent of the pesticide residues in food. Does
the FDA now have the capacity to routinely analyze all the chemi-
cals likely to become residue on food?
Mr. SHANK. Mr. Chairman, we are completely familiar with that
report. FDA does have the analytical capabilities to analyze for all
pesticide residues. The point that is being made is that with the
large volume of different chemicals and commodity combinations,
the multiresidue methods that we routinely rely upon account for
somewhere between 40-50 percent on a routine basis. But we can go
to the other commodity-pesticide combinations which we routinely
do if we have a reason to suspect or have a need to do so.
The CHAIRMAN. So you "routinely" do that?
Mr. SHANK. That may have been a poor choice of words-which
we often do whenever we have a reason to look at that particular
pesticide residue.
The CHAIRMAN. How frequently?
Mr. SHANK. Senator, the basis of our program is the multiresidue
methods which cover approximately 50 percent of the tolerances
that have been established.
The CHAIRMAN. Ms. Fisher, let me ask, what is the administra-
tion's plan for moving on food safety this year? Do they have any?
Ms. FISHER. Yes, Senator. As you know, the President has sup-
ported amending both FIFRA and FFDCA, focusing particularly on
seven points. We are working within the administration and hope-
fully shortly, sometime this summer, we will have clarified our po-
sitions and get them up to you.
The CHAIRMAN. Fine.
Senator Simon.
Senator SIMoN. May I take advantage of your presence to ask
you about something that is not included at the present time in the
proposal? May I ask you about the whole question of imports and
what we do in this area.
What percentage of the fruits and vegetables that we consume
are imported? Do any of you know?
Mr. HALEY. About one-third.
Senator SIMON. About one-third. Any comments from any of you
on the safety of the fruits and vegetables we consume that are im-
ported?
Mr. HALEY. Senator, through our monitoring program-and I
would suggest that we probably don't look at as many samples as
we'd like-but we find very comparable rates as far as those resi-
dues that are on produce or on product that would violate the tol-
erance. We're talking in the range of one to 4 percent of those that
we look at that we have problems with domestic imports. It is
slightly higher for imported, but in the same ball park.
Senator SIMON. When you say you don't do as much as you
would like, do you do enough so that you feel confident in telling
me that it's slightly higher but not significantly higher than what
is accurate?
Mr. SHANK. The confidence that we have comes from the history
and the data that we have accumulated. Year after year, we see
similar results. The data that the States provide to the system,
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65
which is more than what FDA generates themselves, their results
are consistent with ours. It is through that manner of the accumu-
lation of evidence, if you would, that we feel comfortable, not nec-
essarily what we do any 1 year.
Senator SIMON. And do you feel a similar comfort with meats
that are imported?
Mr. HALEY. Senator, let me see if I can answer your question.
When I was with the State of California no more than 2 years ago,
we did a lot of food inspection, 16,000 samples, and we did a lot of
imports. And I think to corroborate what~Mr. Shank has said, we
found very similar results. Approximately 85 percent of the food
coming in had no residues; 13 to 14 percent had residues under 50
percent of the tolerances, and we had some violation rates of one or
2 percent. It doesn't mean that those problems were health viola-
tions; they were because of drift or other things.
That is FDA's findings; it is the State of California's general find-
ings; it is the State of Florida's general findings, Texas, Michigan
and New York. You'd think somewhere around the country we
would have a blip in it, but it is an actual picture of our food
supply.
Senator SIMON. And are you talking about fruits and vegetables
only?
Mr. HALEY. Fruits and vegetables. In regard to meat, we have a
system at USDA that requires and "equal to" inspection system
that we verify for those meats coming into the country, so we have
some confidence that the meat coming in here is as safe as the do-
mestic supply.
Senator SIMON. A former director of the FDA told me that in
terms of meat supply, there just weren't have adequate protections
in terms of inspections. That is not accurate?
Mr. HALEY. I am not saying that that does not happen on occa-
sion, and while we go around and monitor these inspection facili-
ties, we have that inspection here coming into the country. So our
meat inspectors are involved in that process.
Senator SIMON. Mr. Shank, do you wish to comment?
Mr. SHANK. Yes, Senator. I yielded the floor to USDA because
they are responsible for the meat products, and I don't take excep-
tion with what he said.
Senator SIMoN. Let me ask all three of you: what about the abili-
ty to send pesticides to other countries that are prohibited in this
country?
Ms. FISHER. Under current law EPA does not have the authority
to prohibit the export of a pesticide that we have banned here. The
administration has supported an amendment to FIFRA that would
give us that authority. But today it is legal-if I ban a pesticide in
America because of its health risks, manufacturers can still
produce it here and sell it overseas.
Senator SIMON. And you would support a change in the law in
that regard?
Ms. FISHER. Yes. We have supported changing FIFRA to allow us
to ban the export of a pesticide that we have banned for use in
America.
Senator SIMoN. What about not only permitting you to do it, but
requiring you to do it?
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66
Ms. FISHER. The same, yes.
Senator SIMoN. OK. Any comments from Mr. Shank or Mr.
Haley on that? [Pause.] I gather you concur with Ms. Fisher by
your silence.
Mr. SHANK. Yes, I support the fact that additional controls in
these areas would be beneficial. However, I would hasten to point
out that through our monitoring data and the data we have avail-
able to us, this so-called "circle of poison" does not demonstrate
itself in the data.
The residues for those persistent pesticides that remain behind
are very low, and we have not seen any evidence of potential public
health concern.
Senator SIMON. But is it not a fact that there are areas in other
countries where they use pesticides for products locally consumed,
but do not export these products to the United States because they
know they would have problems here? Aren't we in fact endanger-
ing citizens in those other countries?
Mr. HALEY. I think it is important to note that the administra-
tion position agrees substantially with the . language of that bill
that prohibits the export of "bad actors", those that are environ-
mentally and toxicologically of significance. So we support that
concept. What we don't support is the prohibition of pesticides that
are used in a different country for a variety of other reasons-cli-
matic, soil types and the like-that have OECD registration, as
Linda said, have analytical methods, have a prior informed consent
law, and that information is available to us.
We still maintain that any of those products that are not regis-
tered in this country cannot come into this country, but we do not
dictate our system on other areas of the world.
Senator SIMON. I understand.
I thank you. I think this is an area where, frankly, we do need
some action, and I hope we can get it.
Thank you, Mr. Chairman.
The CHAIRMAN. I would agree with Senator Simon. The complex
reality is that a lot of these companies, when we do ban certain
pesticide use, go overseas and produce it and ship it. That's what
we've seen with the pharmaceutical companies over a period of 25
or 30 years. So it is a difficult and challenging issue, and I'm basi-
* cally in strong support of the points that Senator Simon has made.
I want to thank all of you very much for your responsiveness and
your help.
On the third panel we'll hear from Janet Hathaway, Natural Re-
sources Defense Council; Enrique Guardia, representing the Na-
tional Food Processors Association; Sherwin Gardner from Grocery
Manufacturers of America, and Jay Vroom, president of the Na-
tional. Agricultural Chemical Association.
We'll start with Ms. Hathaway. If you'd be good enough to sum-
marize your testimony, we'd be very grateful for that.
Ms. HATHAWAY. I'd be happy to do that, Mr. Chairman.
The CHAIRMAN. We appreciate very much your presence, and
we'll include all the statements in their entirety in the record.
PAGENO="0071"
67
STATEMENTS OF JANET HATHAWAY, SENIOR ATTORNEY, NATU-
RAL RESOURCES DEFENSE COUNCIL, WASHINGTON, DC; ENRI-
QUE J. GUARDIA, SENIOR VICE PRESIDENT OF SCIENTIFIC RE-
LATIONS, KRAFT GENERAL FOODS, ON BEHALF OF NATIONAL
FOOD PROCESSORS ASSOCIATION, WASHINGTON, DC, ACCOM-
PANIED BY CLAUSEN ELY, COUNSEL; SHERWIN GARDNER,
SENIOR VICE PRESIDENT, SCIENCE AND TECHNOLOGY, GRO-
CERY MANUFACTURERS OF AMERICA, WASHINGTON, DC; AND
JAY VROOM, PRESIDENT, NATIONAL AGRICULTURAL CHEMI-
CALS ASSOCIATION, WASHINGTON, DC
Ms. HATHAWAY. Mr. Chairman, I appreciate the opportunity to
testify before this committee about the risks that children face
from pesticides in food.
Two years ago, NRDC conducted a study that has been the sub-
ject of some debate, and I want to take a moment to address that
before we get into some of the details of your legislation.
Just yesterday, there was an unfortunately very misleading and
in some ways very mistaken New York Times front page article
about alar, implying that there was really no risk from alar and
that there had been hysteria in the public that was produced, I
guess, the implication was intentionally by the Natural Resources
Defense Council.
That's just flatly wrong. The study that we conducted was a very
deliberative two-year effort to identify the actual residue levels, the
actual consumption patterns, and the real risks that children face
from pesticides in food. Of the 23 pesticides we looked at, the risk
was much, much higher from alar, and as a consequence that was
the subject of a lot of public attention and media attention.
But let me just go over a couple of the basic assumptions so
people understand there was no way in which that was a worst
case analysis. It was a real world analysis. And in fact Dr. Jackson
just handed me an article that California Department of Health
Services just published, saying that the NRDC study was not a
worst case analysis and that indeed the California Department of
Health Services believes that the risk from alar may be even
higher than we estimate it.
First, the risk that we looked at was only the risk from UDMH,
the breakdown product. Alar itself may or may not be a carcino-
gen. We didn't assume it to be a carcinogen. We just looked at the
risk from the breakdown product which occurs especially in the
processing of apple products.
Second, we looked at not the legal limit, not the actual tolerance
level of the pesticide in food, but the residues that Uniroyal, the
manufacturer itself, said were in the food in 1986. They conducted
a study at the request of EPA.
Third, we looked at actual consumption. People have suggested
that thousands of pounds would have to be consumed of this prod-
uct. Not so. The average consumption of a child under age 6 is
three ounces of apple products. You probably know many children
certainly consume more than that. But we looked at that, and that
was the average, and we used that data in constructing the kind of
risk that was involved.
PAGENO="0072"
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And fourth and I think most importantly, our number does not
significantly differ from EPA's conclusion about alar and UDMH.
EPA said that the risk for the average adult was essentially 50
times the acceptable level, the one in one million level. NRDC said
that the risk for children under age 6. was 250 times the one in one
million level. Both EPA and we agree that kids' risk is much
higher; EPA never put a number on what they thought that kids'
risk would be.
So that's where it stands, and I do think that alar is important to
remember because it is a real world case of what happens when we
don't have an adequate and responsive regulatory program that in
advance averts these kinds of food chemicals from being in the pro-
duction process.
Alar is one instance of it. Aldicarb is another. Aldicarb was re-
moved from the market. I think it was commendable that it was
done by a voluntary cancellation by the companies. But it should
never have been allowed to be used at those levels. And I think
that that is a very important point to be made. There were thou-
sands of poisonings in California as Dr. Jackson said. It is not ap-
propriate to use a chemical like that without having substantial
margins of safety.
That's what this bill does. Let's turn to this bill, and I really
want to ask the other panelists to answer why are they afraid of
this bill. If the food supply really is safe, as they have been saying,
if one in one million is routinely met by the food that is in our gro-
cery stores, on our plates when we have dinner, what are they
afraid of in this bill? This bill simply says systematically go
through the pesticides that are on the market; make sure that the
residue levels that are legal are safe; make sure that they are safe
not just for the average adult but for children and other people
who are heavier consumers of the food. That's just common sense.
If the food supply is safe,, nothing is going to change. If some of
these tolerance levels are unsafe, the tolerance levels are going to
have to be revised. I submit that there are tolerance levels that
will have to be revised. I can't tell you how many. I don't think it
is the majority of foods that will have to have those revisions, but I
think it is some, especially in the fruit and vegetable commodities,
the pesticides used on those foods.
Let's admit that there is a real dysfunction between protecting
kids from pesticides in food and what we have been doing in the
past. In the past we have been looking at average adult exposures.
In the past we have been looking at commonplace agricultural
practices and not at the real residues that remain. We have not
looked at the conc~ntrations that occur in kids' diets because of
their lack of diversity in what they consume, and we've got to do
that, and let's just get with the task. That is what this bill says. I
think it is so common sensical that I am surprised that we contin-
ue to debate it.
EPA says that one in one million is the standard they use. Yes-
terday's New York Times said erroneously that if a chemical poses
more than a one in one million risk, EPA is required by law to ban
it.
I wish that were so. That's not so. This bill would require that
the tolerance levels be such that no one would be experiencing
PAGENO="0073"
69
more than one case of cancer out of a million people exposed kind
of risk. That is prudent. That is a step that goes very far in the
right direction. And I applaud the chairman and other members
who have supported that legislation.
Thank you.
[The prepared statement of Ms. Hathaway follows:]
47-693 0 - 91 - 4
PAGENO="0074"
70
Prepared Statement of Ms. Hathaway
Thank you for the opportunity to testify before this committee about S. 1074, the Safety
of Pesticides in Food Act of 1991. I am Janet Hathaway, a senior attorney with the Natural
Resources Defense Council (NRDC), a national, nonprofit environmental organization dedicated
to protecting public health and the environment. This testimony is also submitted on behalf of
my colleagues, Al Meyerhoff and Lawrie Mott, who have devoted over a decade to improving the
safety of the food supply and the environment, particularly with regard to reforming the use of
agricultural chemicals. Al Meyerhoff is a senior attorney and Lawrie Mott is a senior scientist
with NRDC's San Francisco office.
During the last decade, NRDC has issued a series of reports documenting the hazards of
pesticides in the food supply. In 1989, we released Intolerable Risk: Pesticides in Our Children's
Food which documents that the risks from actual residue levels of 23 pesticides used in 27 fruits
and vegetables greatly exceed even the government's own standards for acceptable risk.1 Earlier
NRDC reports described the unique pesticide risks associated with imported food,2 the extent of
pesticide contamination of fruits and vegetables,3 and the inadequate government regulation of
pesticides on food.4
We have testified many times before the Senate Labor Committee and other Congressional
committees concerning the need to reform federal pesticide laws. We are here today to support
1. Sewall, B., R. Whyatt. and J. Hathaway, Intolerable Risk: Pesticides in Our Children's
Food, 1989.
2. Hearne, S., Harvest of Unknowns: Pesticide Contamination in Imported Foods, 1984.
3. Mott, L. and K. Snyder, Pesticide Alert, 1987.
4. Mott, L. and M. Broad, Pesticides in Food: What The Public Needs To Know, 1984.
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S. 1074 as a positive step on the long road ahead to protect the public from the hazards of
pesticides. By establishing purely health-based standards for pesticides in food, this legislation will
substantially improve the safety of our food supply. This legislation should be strongly and rapidly
endorsed by the Congress and signed by the President. Changes are needed not just in the law
but also in practices used to grow our food at farms and orchards across the country and
throughout the world. In the long term, public health and the environment will be best protected
by phasing out the use of known hazardous pesticides with the use of safer alternative pest
control methods.
PESTICIDES IN FOOD:
THE SLOW POISONING OF THE AMERICAN PUBLIC
Five years ago, the Director of EPA's Pesticide Program during the Reagan administration
said. "Pesticides dwarf the other environmental risks the Agency deals with. Toxic waste dumps
may affect a few thousand people who live around them. But virtually everyone is exposed to
pesticides."5
Recently, Administrator Reilly echoed these remarks, stating:
"The [EPA] Science Advisory Board identified pesticides among the top priority
concerns, both as they affect applicators and also the consumer of food containing
pesticide residues. I propose now that we make food safety a top environmental
legislative priority in the new Congress.... President Bush and I both understand
and share the public's frustration. We ~ national pesticide laws are arcane and
antiquated."6
5. Shabecoff, P., "Pesticide Control Finally Tops the EPA's List of Most Pressing Problems,"
New York Times, March 6, 1986.
6. Address by William K. Reilly, Administrator, United States Environmental Protection
Agency, to the Commonwealth Club, San Francisco, CA, January 9, 1991.
2
PAGENO="0076"
72
But action has not matched rhetoric. Pesticides continue to be routinely allowed in the
nation's food supply with woefully inadequate regulation or e~n detection. According to the
state and federal pesticide monitoring data for the years 1982 to 1985, a total of 110 separate
pesticides were detected in 48 percent of the samples tested. Many of these substances have
been linked to cancer, nerve damage, genetic mutations and other adverse health effects.
However, the full extent of pesticide contamination of the food supply is unknown, primarily
because the government's routinely-used residue monitoring techniques do not detect many
pesticides applied to food. The Congressional Office of Technology Assessment found that the
U.S. Food and Drug Administration's (FDA) primary laboratory method can detect only about half
the pesticides registered for use on food. For the rest, we are regulating -- or not regulating --
out of ignorance.
At least 63 of approximately 300 pesticides used on food have been classified by EPA as
"probable" or "possible" human carcinogens. The cumulative risk to the public health, especially
the health of children, from this daily dose of toxic chemicals is unknown. However, disturbing
new data indicate an increasing incidence of cancer generally.
One out of nine American women will now contract breast cancer during their lifetime, a
more than one-third increase in just this decade. Among children fourteen and younger, the
incidence of cancer in the United States has increased 21.5 percent from 1950-1986, according to
the National Cancer Institute. Other forms of cancer also are on the rise. Even adjusted to
account for increases caused by an aging population, there have been sharp increases in: brain
cancer (up 22.3 percent), bladder cancer (up 49.2 percent), testicular cancer (up 92 percent), skin
cancer (up 263 percent), kidney cancer (up 95 percent) and non-Hodgkins lymphoma (up 130
percent). All new cancer cases combined have risen by 37 percent. New cancer cases, excluding
lung cancer, have risen 27 percent. More than one million Americans will learn they have cancer
PAGENO="0077"
73
this year; half a million will die from it.7 How much of this cancer, and the human suffering it
engenders, resulted from pesticides? While EPA has tried to quantify it at six thcuisand cancers
per year, no one really knows. Prudence and common sense dictate that a sound public policy
should result in reduction or prevention of exposure to substances known to cause cancer,
especially children's exposures.
Regrettably, EPA continues to stress "management" of risk from cancer and other
pernicious diseases rather than prevention. As a result of the 1988 amendments to the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) requiring comprehensive testing of pesticides,
more and more pesticides found in processed foods are now being determined to cause tumors.
They have not been eliminated from our food supply even decades after their cancer-causing
potential was revealed. Yet in enacting the Delaney Clause of the Federal Food, Drug and
Cosmetic Act Congress expressly and unequivocally prohibited such residues. Rather than comply
with the law, the Agency has simply chosen to "amend" it by administrative fiat, both intruding
upon the power of Congress and failing to protect the public health as well. The Agency's failure
is now being tested in the courts,8 As a result, nationwide injunctive relief, rather than thoughtful
regulatory action, may soon be brought to bear on numerous carcinogenic pesticides now being
discovered in food.
7. National Cancer Institute, 1989, American Cancer Society, 1986. "Cancer Facts and
Figures," as cited in Dr. Devra Lee Davis, "Natural Anti-carcinogens: Can Diet Protect
Against Cancer?" Healthy & Environment Digest, February 1990.
8. People of State of California, et al. v. William K. Reilly, et al., No. S-89-0752-RAR-EM
(E.D. Cal. May 25, 1989).
Kathleen E. Less, Petitioner, et al. v. William K. Reilly, et al., Respondent No. 91-70234
(9th Circuit, April 12, 1991).
4
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II.
POLLUTION PREVENTION:
REDUCING THE USE OF PESTICIDES
The question of chemical residues on the food we eat is a hotly debated issue.
The existence of such residues is either played down by the industry as unimportant
or is flatly denied. Simultaneously, there is a strong tendency to brand as fanatics
or cultists all who are so perverse as to demand that there food be free of insect
poisons. In all this cloud of controversy, what are the actual facts? [...]
The system by which the Food and Drug Administration establishes
maximum permissible limits of contamination, called "tolerances," has obvious
defects. Under the conditions prevailing that provides merely paper security and
promotes a completely unjustified impression that safe limits have been established
and are being adhered to. As to the safety of allowing sprinkling of poisons on
our foods -- a little on this, a little on that -- many people contend, with highly
persuasive reasons, that no poison is safe or desirable on food. [...} In effect, to
establish tolerances is to authorize contamination of public food supplies with
poisonous chemicals in order that the farmer and the processor may enjoy the
benefit of cheaper production -- then to penalize the consumer by taxing him to
maintain a policing agency to make certain that he shall not get a lethal dose. But
to do the policing job properly would cost money beyond any legislator's courage to
appropriate, given the present volume and toxicity of agricultural chemicals. So in
the end, the luckless consumer pays his taxes but gets his poisons regardless. [...}
This system, however -- deliberately poisoning our food, then policing the
result -- is too reminiscent of Lewis Carroll's white knight who thought of "a plan
to die one's whiskers green, and always use so large a fan that they could not be
seen." The ultimate answer is to use less toxic chemicals so that the public hazard
from their misuse is greatly reduced. [...] In addition to making this change to less
dangerous agricultural pesticides, we should diligently explore the possibilities of
non-chemical methods. A great many other possibilities exist for effective insect
control by methods that will leave no residues on foods. Until a large-scale
conversion to these methods has been made, we shall have little relief from a
situation that, by any common sense standards, is intolerable. As matters stand
now, we are in little better position than the guests of the Borgias.9
For three decades since Rachel Carson wrote these stirring words, calls for essential reform
of the nation's food safety laws have gone largely unheeded. When governmental agencies or
private groups have demonstrated that pesticide regulation is necessary in order to protect public
9. Rachel Carson, Silent Spring, 1962, pp.182-184.
5
PAGENO="0079"
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health, a "parade of horribles" has been conjured up by the food and agrichemical industries
opposing government action. Chemical by chemical, we have been told that pesticides were
"essential" to food production and that their elimination, despite clear health hazards, would wreck
havoc on segments of American agriculture. Chemical by chemical, after excruciatingly long
bureaucratic delays and public debate, these claims were proven false. In the early years, these
apocalyptic predictions were made for the chlorinated hydrocarbons (e.g., DDT, aldrin and
dieldrin). After years of litigation, these substances were finally removed from the marketplace
with no noticeable impact on agricultural yields or production. During the Nixon and Carter
Administrations, it was DBCP that stirred the greatest controversy. DBCP is a human carcinogen
and potent reproductive toxin. DBCP users and manufacturers claimed that removal of DBCP
from the market would have a devastating impact on the production of citrus and other
commodities. After a decade of controversy, the pesticide was finally banned, first by California
and then by EPA. Citrus yields increased. But Americans continue to be exposed to DBCP,
which has now contaminated some 2,000 drinking water wells in California alone. A lawsuit
brought by the city of Fresno is now pending against DBCP's producers for several hundred
million dollars in damages resulting from DBCP pollution of Fresno's drinking water supply. Birth
defects and other reproductive harm have already been attributed to DBCP; its long-term cancer
impact remains to be seen.
During the Reagan Administration, the spotlight was on ethylene dibromide (EDB), used
to replace DBCP and also a potent carcinogen and reproductive toxin. Again Americans were
told that EDB was vitally necessary for grain fumigation, as a nematicide used on citrus, and for a
variety of other purposes. Again, apocalyptic claims about its proposed removal were made by its
producers and by representatives of the food industry. Following years of litigation and a series
of scandalous closed-door meetings between high-level EPA officials and the regulated industry, a
6
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major public controversy and action by several individual states combined to convince then
Administrator William Ruckeihaus to ban the chemical. Interestingly, grain supply did not dwindle
and citrus yields did not diminish. Also during the Reagan Administration, heptachlor, a known
carcinogen, was found to contaminate much of the milk in the state of Hawaii. Its use had been
permitted on pineapples whose leaves were fed to dairy cows. Before this use was finally banned,
90 percent of Oahu's milk had to be destroyed.
During the Bush Administration, the pattern continues. A few years ago, EPA announced
its intention to ban the pesticide dinoseb because of highly disturbing test data in laboratory
animals demonstrating that it caused deformities of the fetal brain and spine, male sterility and
reproductive harm. Representatives of the agricultural industry, particularly from the Pacific
Northwest, utilized their political muscle to prevent dinoseb's removal from the market. Again, we
were told that the ban of dinoseb would have dramatic adverse economic impacts on the
production of caneberries and other crops for which no alternative pest control method was said
to be possible. Years later, EPA eventually prevailed in the courts, and dinoseb was removed
from the market. The production of caneberries continues unabated.
Perhaps the most notorious case of false claims of "essentiality" is the now well-known case
of the growth regulator Alar. Studies linking Alar and its metabolite UDMH to cancer appeared
as early as 1973. The EPA proposed to cancel all food uses of Alar in the fall of 1985, but
following a series of private meetings with pesticide industry representatives, its use was allowed to
continue. In the spring of 1989, a report issued by the Natural Resources Defense Council
documented the health risks posed by Ajar and UDMH, especially to infants and young children
as a result of children's consumption patterns of apple products at levels ten times or more than
that of adults. The Environmental Protection Agency stated that the cancer risks presented by
Alar were "unacceptable" and EPA's Administrator "found an inescapable correlation between
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exposure to UDMH and life-threatening tumors" in laboratory animals. In response, Alar's
manufacturer, the Uniroyal Corporation. claimed that Alar's removal from the market would have
devastating effects on apple production, yields and quality. Nevertheless, increasing consumer
pressure, as well as the threat by Congress itself to ban the substance, finally convinced its
manufacturer to "voluntarily" withdraw Alar from the market worldwide. Contrary to industry's
claims, since Alar's removal from use, apple yields, price and quality have not diminished. `Indeed,
last year's apple harvest was among the highest in the last 20 years.
It is no wonder that public confidence in the food supply has been shaken. It is no
wonder that opinion polls consistently show deep-seated public support for reform of the nation's
food safety laws. Given this sorry record of crying wolf, claims by industry that purported
"benefits" and "essentiality" of known cancer-causing agents must outweigh their health risks should
be given short shrift. Rachel Carson was right: "The ultimate answer is to use ~ toxic chemicals
so that the public hazard from their misuse is greatly reduced." In the short term, strict controls
should be placed on residues in order to reduce the threat of cancer and other adverse health
effects as much as possible. In the long term, given the vagaries of cancer risk assessment and
the overall adverse environmental impact of pesticides, including by contaminating drinking water
supplies, the workplace, and rural communities, dangerous chemicals should be phased out of usc
entirely. Alternative, safer pest control methods should be researched, promoted and used more
comprehensively in all sectors of agriculture.
In a report describing EPA's accomplishments in the last two years, EPA Administrator
William Reilly announced that pollution prevention is the best way to reduce risk. With
pesticides, numerous alternative agricultural techniques are already available to reduce the use of
these chemicals. Last month, NRDC released Harvest of Hope: The Potential for Alternative
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Agriculture to Reduce Pesticide Use.° This two-year research project revealed that currently
available alternative agricultural methods could reduce pesticide applications between 25 and 80
percent in nine U.S. crops.
The promise of alternative pest control remains unfulfilled. Its implementation, which
could be greatly enhanced by enactment of S. 1074, will not only improve the safety of the food
~supply. It will also reduce the increasing threat agricultural chemicals pose to the nation's public
health, groundwater, and environment as a whole.
III.
THE DELANEY CLAUSE IS VITAL TO THE PROTECTION
OF OUR FOOD SUPPLY FROM CARCINOGENIC COLOR ADDITIVES.
FOOD ADDITIVES AND ANIMAL DRUGS
In addition to the Delaney Clause which pertains to pesticides in processed food, which
this bill would modify, there are three other Delaney clauses in the food law which prohibit
carcinogenic food additives, color additives and animal drugs. Many food industry representatives,
as well as the Food and Drug Administration, have sought to amend or repeal the other three
Delaney clauses in the FFDCA.' NRDC strongly opposes any such effort. An absolute
prohibition on carcinogens is the appropriate standard for regulating food additives, color additives
and animal drugs. We would vehemently oppose amendments, even if coupled with improvements
to the regulation of pesticides, which undermine the strict Delaney prohibition on those
10. Curtis, J., T. Kuhnle and L. Mott, Harvest of Hope: The Potential for Alternative
Agriculture to Reduce Pesticide Use, 1991.
11. In 1988, an FDA official told the House Energy and Commerce Committee, "We believe
that this [negligible risk] reasoning reflects good public policy and should also apply to other
substances regulated by FDA that are subject to Delaney provisions." Testimony of John M.
Taylor, Associate Commissioner for Regulatory Affairs, Food and Drug Administration, before
the Health and Environment Subcommittee, House Energy and Commerce Committee, June
23, 1988, p. 4.
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carcinogenic substances used as food additives, color additives or animal drugs. Improved safety of
the pesticides used in our food supply must not be achieved at the expense of increasing the
hazards from other carcinogenic substances in food.
IV.
5. 1074 IS ESSENTIAL
TO IMPROVE ThE SAFETY OF OUR FOOD SUPPLY
A. S. 1074 REQUIRES PESTICIDE TOLERANCES TO POSE NO MORE THAN A
NEGLIGIBLE RISK, INCLUDING FOR INFANTS AND CHILDREN.
The centerpiece of this bill is the requirement that pesticides used in food must pose no
more than a negligible risk, defined as a rate of adverse human health effects of no more than
one case in a population of one million exposed people. The bill requires that the EPA must
ensure that "identifiable population groups (such as infants and other children)' are not subjected
to a higher risk level. NRDC regards this provision as essential to public health protection.
EPA's pesticide risk assessments and the resultant regulatory decisions generally assume an
"average" diet. Average consumption estimates, which are derived by dividing the total quantity of
a food sold in the United States by the total U.S. population, has very little relevance to the real
consumption by individuals. Virtually every individual's diet deviates considerably from that of an
average American's. Most individuals concentrate their diets on certain "favorite' foods and avoid
other foods altogether. The consequence is that EPA's pesticide tolerances protect the
theoretically average consumer -- but not the actual person who eats an apple, or two, a day.
EPA's tolerances do not protect consumers from developing cancers or other diseases caused by
pesticides remaining on food. S. 1074 would require EPA to ensure that tolerances protect
infants, children and other people who eat more than "average" amounts of food treated with
pesticides.
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1. Explanation of Children's Enhanced Risk
NRDC demonstrated in our Intolerable Risk study that preschoolers have greater exposure
to pesticide residues than adults. This is so because preschoolers eat more food, relative to their
weight, and consume much larger quantities of fruit, which has a high likelihood of being
contaminated with pesticides. Fruit comprises 20 percent of the adult diet and 34 percent of the
preschooler's diet. Preschoolers eat six times as much total fruit, seven times more grape products
and seven times more apples and applesauce, relative to their weight, than adults. Apple juice is
a particular favorite of children. The typical preschool child consumes almost 18 times as much
apple juice and the typical toddler more than 31 times as much apple juice, relative to their
weight, as the average adult woman.
Fruit is highly likely to contain pesticide residues. The 1987 FDA's food monitoring
program found that 50 percent of all fruit samples had detectable levels of pesticides. This
residue rate is higher than that of any other commodity and may significantly underestimate the
full extent of residues because FDA's monitoring program does not routinely monitor for nearly
half of the pesticide residues in food.
NRDC's analysis of exposure, based on a USDA study of food consumption by children
and women, determined that relative to their weight preschoolers receive much greater exposure
than adults to the majority of the pesticides analyzed in this report. The average preschooler
receives more than five times greater exposure to the fungicide mancozeb, nine times greater
exposure to the neurotoxic organophosphate azinphos-methyl and 12 times greater exposure to
UDMH, the carcinogenic metabolite of daminozide, than adults. The typical preschooler receives
four times greater exposure, on average, than adults to the eight carcinogenic pesticides evaluated.
The youngest children receive the greatest pesticide exposure. Relative to adult women, toddlers
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receive more than eight times the exposure to mancozeb, 15 times greater exposure to azinphos-
methyl and 18 times greater exposure to UDMH, than women.
B. S. 1074 REQUIRES ThAT EPA ACCURATELY ASSESS EXPOSURE.
S. 1074 strengthens the federal pesticide regulatory program by requiring a more accurate
assessment of exposure to pesticide residues as a prerequisite to a new pesticide tolerance. The
bill requires that a pesticide legal limit take into account the other uses of the same pesticide on
food and the other exposures to the pesticide the consumer experiences through the diet (such as
through drinking contaminated water). These provisions are vital if the pesticide limits are to
reflect the actual exposures experienced by our citizens.
The bill requires that exposures be evaluated on the assumptions that all commodities on
which the pesticide's use is legal are treated with the pesticide. that the residue levels equal the
pesticide tolerance level, and that exposure at the legal limit is likely to occur over a lifetime.
These are reasonable assumptions which are necessary to ensure that the exposures of some
members of society are not being ignored. The bill provides an exception whenever EPA has
reliable data showing that less of the crop is treated and that the treated portion of the crop is
distributed in a way which ensures that the risk is distributed evenly among consumers of the
commodity.
EPA has not routinely lowered tolerances upon a finding that the legally permissible
concentrations of pesticide residues would cause high risk of cancer or other adverse effects.
EPA often dismisses these findings by stating that residues are normally below tolerance levels,
but EPA does not concomitantly lower the tolerances to what it has declared to be the "normal"
level. Consequently, people today may unwittingly consume foods that, although legal, contain
pesticide levels which EPA's data demonstrate to be unsafe.
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Legal food should be safe food. Without prohibitively expensive chemical analyses of all
food, consumers cannot identify which foods bear high residues and which have lower, safe
concentrations of pesticides. Therefore, EPA should ensure that consumption of food with
residues at the legal maximum is, in every case, safe. EPA should perform risk assessments based
on the assumption that pesticide residues will be present at the maximum legal concentration. If
EPA, growers or the food industry believe that such a risk assessment overstates the risk, they
should demonstrate that actual residues are lower and petition for a lower legal limit. This is how
S. 1074 would function. The bill in effect requires EPA to limit pesticide residues to the level
EPA calculates will result in no more than a negligible risk to any consumer of the food.
C. 5. 1074 REQUIRES THAT EPA ESTABLISH PRACTICAL METHODS OF
ANALYSIS FOR ALL PESTICIDES.
Pesticides should not be used on food if FDA cannot readily detect the residues in food.
Without the ability to detect residues at reasonable cost, FDA cannot enforce EPA's tolerances
and therefore cannot protect the public from pesticide residues in food. S. 1074 recognizes this
fact and corrects the current anomalous situation in which dangerous pesticides are used on food
or which government agencies cannot routinely find by their monitoring methods.
FDA monitoring for pesticides is inadequate to ensure that residues are legal, let alone
safe. Of the 496 pesticides FDA has identified as likely to leave residues in food, FDA's routine
analytical methods can only detect 203 -- only 41 percent.'2 Of the 105 pesticides which FDA
considers to pose a moderate to high health hazard, only 58 (55 percent) are detectible using the
FDA multi-residue methods.'3 Among the commonly used pesticides which cannot be detected by
12. GAO, Pesticides: Need to Enhance FDA's Ability to Protect the Public from Illegal
Residues, October 1986, p. 33.
13. Ibid, p. 36.
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FDA's multi-residue methods are benomyl, daminozide, the EBDC fungicides and paraquat.'4
Twenty-six of the 53 pesticides identified by EPA as potentially oncogenic for the 1987 NAS
report on pesticides in food cannot be detected by FDA's multi-residue method.
EPA should require that manufacturers of pesticides used on food develop practical
methods for detecting pesticide residues. An analytical method should be considered practical only
if the method: (1) reliably and routinely quantifies the level of residue in food with sensitivity
sufficient to enforce the tolerance; (2) provides results in less than eight hours; (3) can be used in
FDA labs with existing FDA laboratory equipment; and (4) costs no more than what is typically
incurred by the FDA in using a multi-residue method. The bill would encourage the development
of multi-residue methods for a wider range of pesticides. S. 1074 would greatly improve FDA's
ability to enforce the pesticide tolerances.
D. S. 1074 REQUIRES THAT PESTICIDE "INERT" INGREDIENTS HAVE
TOLERANCES UNLESS TIIEY ARE CHEMICALS WHICH POSE NO SIGNIFICANT RISK.
The federal pesticide law distinguishes between active ingredients, which kill, repel or
otherwise control pests, and so-called "inert" ingredients, substances which are used to dilute,
propel or stabilize the active ingredient.15 In many instances, the non-active ingredients are
extremely toxic chemicals.16 EPA has broadly exempted ~ii of these "inert" ingredients from
regulation under the FDA. NRDC believes that current law requires EPA to set tolcrances for
14. Ibid, p. 39.
15. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. § 136(a) and
§136(m).
16. EPA has listed 57 inert pesticide ingredients `of toxicological concern." 52 ~gç~gt~.i
Regisici 13305, April 22, 1987. Included on EPA's list were extremely dangerous chemicals,
some of them restricted or cancelled for use as active ingredients by EPA, such as benzene,
carbon tetrachloride, chloroform, formaldehyde, and mercury oleate.
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these ingredients. However, we fear that litigation may be necessary to motivate EPA to set
tolerances for these dangerous pesticide ingredients.
S. 1074 requires EPA to revoke the food uses of dangerous "inert" ingredients unless they
have a tolerance which ensures that they pose no more than a negligible risk. This provision
would greatly enhance food safety. Because many so-called inert ingredients today are actually
toxic chemicals, there may be instances in which the pesticide may pose excessive risks not
because of the active ingredient but instead because of the substance used to dilute, propel, or
stabilize the formulation.
Inert ingredients are generally not essential to the pesticide product. If a manufacturer
wants to continue to use the active ingredient in or on food, the manufacturer should substitute
an innocuous ingredient for the one posing a significant health threat. If an entirely innocuous
ingredient cannot be found, the pesticide manufacturer must have the burden of testing the
ingredients and demonstrating that, at the tolerance level, they will pose no more than a negligible
risk in combination with the active ingredients. EPA should never allow residues of an inert
ingredient to pose a significant health hazard.
E. THE BILL PROVIDES EPA WITH EXPLICIT AUTHORITY TO IMMEDIATELY
REVOKE OR MODIFY TOLERANCES WHEN NEEDED TO AVERT AN "IMMINENT
HAZARD."
In 1988, EPA Assistant Administrator Dr. John A. Moore testified before the House
Energy and Commerce Committee this Committee that under current authorities, EPA's revocation
of a tolerance due to a registrant's failure to submit data promptly is labor-intensive and time-
consuming. He suggested that revocation, when challenged by registrants, may take at least two
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years.'7 Dr. Moore expressed the need for a provision in the law automatically revoking
tolerances where data-submission deadlines are missed." NRDC believes that food safety
legislation should contain provisions automatically revoking tolerances if required data are not
submitted in accordance with statutorily defined deadlines. S. 1074 appropriately provides this
necessary authority.
V.
S. 1074 NEEDS STRENGTHENING IN ORDER TO ENSURE
THAT PESTICIDES IN FOOD DO NOT ENDANGER PUBLIC HEALTH.
NRDC WILL OPPOSE ENACTMENT OF ANY BILL WHICH WOULD ERODE
THE PURELY HEALTH-BASED STANDARD OF S. 1074
OR WEAKEN STATE POWERS OVER PESTICIDES.
A. NRDC URGES THE COMMITFEE TO ADOPT AN AMENDMENT TO REQUIRE
THE ELIMINATION OF ALL PESTICIDES WhICH ARE PROBABLE HUMAN
CARCINOGENS BY TIlE YEAR 2000.
Even though 5. 1074 will help to reduce residues of carcinogenic pesticides in food, NRDC
believes the bill should ultimately eliminate use of pesticides which are probable human
carcinogens. Though the bill is an excellent interim measure, there are reasons to phase out all
substances which EPA believes are likely to cause cancer in humans. First, the new tolerances
which would be developed under the bill rely on risk assessment, which may understate the risk
certain pesticides pose for humans. Furthermore, the bill does not ensure that cumulative,
lifetime exposures to the hundreds of pesticides in every American's diet are safe. Finally, the
public needs assurance that, even if federal agencies' implementation of the new law is no more
diligent than their implementation of the old law, the public will ultimately see a substantial
17. Testimony of Dr. John A. Moore, Assistant Administrator for Pesticides and Toxic
Substances, EPA, Regulation of Pesticide Hearing, House Energy and Commerce Committee,
June 8, 1987, p. 172.
18. Ibid, p. 178.
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reduction in the use of carcinogenic pesticides. Particularly given the ubiquitous and often
involuntary exposure to other, non-pesticidal carcinogens -- from radon and cigarette smoke to
automobile emissions -- NRDC considers it imperative that Congress take steps to minimize each
person's exposure to pesticides and other substances which are carcinogens.
NRDC therefore strongly urges this Committee to require EPA to revoke tolerances for
all pesticides which authoritative federal agencies -- such as the EPA, the National Cancer
Institute, or the National Toxicology Program -- identify as "probable human carcinogens."
Alternative pest control methods should be sought for such substances. Unless there is a
Congressionally-mandated deadline for eliminating these dangerous pesticides, pesticide
manufacturers and growers will have no incentive to develop innovative crop protection processes
as alternatives to carcinogenic pesticides. To allow for the time needed to conduct research in
pest management to establish such alternatives, NRDC would be willing to delay the application
of such a provision for a number of years. Nevertheless, the American people deserve the
assurance that by the year 2000 the foods they consume will not contain any pesticide which has
been identified as a probable human carcinogen.
B. NRDC'S SUPPORT FOR S. 1074 IS CONTINGENT ON REJECTION OF
"ECONOMIC BENEFITS" AS A JUSTIFICATION FOR ALLOWING PESTICIDES IN FOOD TO
POSE GREATER THAN A NEGLIGIBLE RISK.
Tolerances should be set at safe levels. Legal food must be safe food. Economic benefits
of the pesticide are irrelevant to the question of how much residue in food is safe. EPA
currently interprets FFDCA section 408 as enabling the Agency to balance the risks of pesticide
with the benefits of the chemical.'9 NRDC believes such an interpretation is unsupported by the
statute, legislative history, or legal precedents. EPA testified before the House Energy and
19. Testimony of John A. Moore, June 8, 1987, ~ p. 170. -,
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Commerce Committee in 1989 in favor of authority to grant tolerances for dangerous pesticides
based on considerations of benefits!°
Benefits considerations can become an enormous loophole to the strict regulation of widely
used but extremely dangerous pesticides. Those familiar with EPA's implementation of the
FIFRA statute have witnessed EPA repeatedly cite economic benefits as the justification for
continuing the registration of very hazardous pesticides. Benefits analyses appear to be developed
in the absence of reliable data and almost invariably result in retaining dangerous uses. Many of
these analyses rely on unsubstantiated claims from the manufacturers or users about the usefulness
of the chemical. Seldom does the EPA consider that non-pesticidal crop protection strategies may
serve as an alternative to pesticide use. "Economic benefits" to the pesticide industry or to
growers, and particularly not the current highly subjective analyses of supposed benefits, should
not be used to justify hazardous residues in our diets.
C. NRDC'S SUPPORT FOR S. 1074 IS CONTINGENT ON CONGRESS' REJECTION
OF ALL EFFORTS TO PREEMPT STATE AUTHORITY TO SET STRICTER PESTICIDE
TOLERANCES.
Proponents of amendments which would preempt states' authority to set tolerances say that
such amendments are needed to prevent a "crazy quilt" of conflicting legal requirements which
complicate or interrupt interstate commerce of agricultural produce. Unfortunately, this assertion
lacks an empirical foundation. Experience has revealed that states exercise their authority to set
more stringent pesticide tolerances cautiously and only in compelling circumstances.
States have acted to set more stringent tolerances only when faced with extreme federal
inertia in the face of ample evidence that public health was not adequately protected by federal
20. Testimony of John A. Moore, Acting Deputy Administrator, Environmental Protection
Agency, before the Committee on Energy and Commerce, Subcommittee on Health and the
Environment, May l~, 1989.
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tolerances. There are approximately 300 pesticides approved for uses on food. Only two
pesticides have been the subject of state efforts to tighten federal tolerances: ethylene dibromide
(EDB) and daminozide (Ajar).
In both instances where states set tolerances more stringent than the federal limits, many
years of federal inaction or ineffective efforts preceded state action. In both instances, compelling
evidence was available on the basis of which state health authorities concluded that the risks from
these pesticides were great, particularly for children. Both times the states tried to motivate the
federal government to act and probably would have preferred swift and decisive federal action.
The EDB and daminozide incidents did not stem from a surplus of conflicting and overlapping
authorities to set tolerances. Instead, these events demonstrate the confusion and danger which
result from the federal government's failure to exercise its authority to revise tolerances when new
data reveal high risks. State authority must be retained as a "fail safe" in the event that the
federal government fails to diligently and effectively implement the food safety law.
VI.
CONCLUSION
NRDC applauds the Chairman for this important piece of legislation to ensure that
pesticides in food are safe. Legislation of this kind is urgently needed to restore public
confidence in our federal programs to protect our food supply. We urge the Committee to
challenge those who maintain that this bill would result in enormous losses to agriculture to
provide data to support their claims. NRDC believes that there is no evidence indicating that
setting pesticide tolerances at a safe level would result in food scarcities or higher consumer prices
for nutritious commodities. This bill does not require the banning of pesticides whenever they
pose any risk. Instead, the bill wisely requires residues of dangerous pesticides to be limited to a
level which is safe for all members of society. This bill would require EPA to phase out the uses
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of pesticides Qj3jy when the chemicals are so dangerous that they cannot be used in agriculture
effectively at levels which pose less than a negligible risk to the public. The American public is
demanding a vastly safer food supply. We hope to work with this Committee to ensure that the
public's demand is heeded.
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The CHAIRMAN. Thank you very much.
Mr. Guardia.
Mr. GUARDIA. Mr. Chairman and members of the committee, I
am Enrique Guardia, vice president of scientific relations for Kraft
General Foods, which is the largest manufacturer of processed
foods in the United States.
I am testifying today on behalf of the National Food Processors
Association, NFPA. Accompanying me is Clausen Ely, with the
firm of Covington and Burling, legal counsel for the association.
Let me stress at the outset that NFPA recognizes the need for
pesticide tolerance legislation, and we are prepared to work toward
enactment of this reasonable tolerance bill in this Congress.
In January of this year, the NFPA announced the comprehensive
food safety legislative proposal to improve regulation of pesticide
residues in food. The overriding goals of the NFPA proposal are to
establish a consistent and scientifically defensible pesticide safety
standard, to simplify and streamline pesticide cancellation and tol-
erance procedures, and to mandate national uniformity for toler-
ances meeting current safety standards.
We support the provisions of 5. 1074 that would harmonize the
safety standards for pesticide residues in rural and processed foods
that would permit sale of food treated with a pesticide for which a
tolerance is later revoked and that would assure an open and
timely tolerance setting process.
NFPA has made clear its support for a uniform negligible risk
standard for pesticide residues in raw and processed food, but not
at the expense of scientific reason, regulatory order or consumer
welfare.
The NFPA has one of the best pesticide residue data banks for
processed foods, and its data along with FDA, USDA and the State
of California have shown that pesticide residues in processed foods
are far below tolerance levels, are significantly reduced from levels
containing raw ingredients, and are ordinarily undetectable.
Now I will address the specific features of the bill that are of
greatest concern to our members.
Negligible risk standards. 5. 1074 would impose a prescriptive
and highly conservative definition of negligible risk. This would
foreclose considerations of scientific advances and restrict regula-
tory flexibility in the same manner as the Delaney clause. Arbi-
trary numerical risk standards should not be case in statutory
stone.
Dietary exposure calculations. S. 1074 would require EPA to
assume that residues occur in 100 percent of crop for which the
pesticide is approved and at full tolerance levels. Food industry and
FDA studies have shown that these assumptions are simply false.
The worst case exposure assumptions required under 5. 1074
would reduce the incentive for farmers to minimize pesticide use.
Benefits. 5. 1074 would eliminate any consideration of benefits in
pesticide tolerance decisions. We strongly oppose this aspect of the
bill because the proposed prohibition of consideration of benefits in
pesticide tolerance decisions is fundamentally inconsistent with
FIFRA and in effect would amend FIFRA for all food use pesti-
cides.
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Also, food use pesticides contribute important health benefits
that can outweigh the hypothetical risks attributed to consump-
tions of residues. Pesticides provide direct health benefit through
control of disease-carrying insects, harmful molds such as aflatox-
ins, and other toxins.
Pesticides also play an essential role in providing a wholesome,
healthy and nutritious food supply. The methodology for negligible
risk determinations include multiple uncertainties and conserva-
tive assumptions. Because of these assumptions, the calculated one
in one million lifetime risk is equivalent to an extremely low risk
or no risk at all. It is thus appropriate for EPA to retain authority
to take into account the benefits of pesticides that pose greater
than a hypothetical one in one million risk.
The bottom line is that without pesticides we will not have an
adequate, wholesome and economic food supply.
Tolerance and uniformity. The bill fails to address the need for
uniform tolerances for pesticides that have been shown to be safe
under current EPA regulations. Permitting different and inconsist-
ent State and local tolerance causes public fear and confusion, dis-
rupts interstate commerce, creates barriers to international trade,
and undermines EPA's regulatory authority.
In conclusion, while we support the eliminating of the Delaney
clause to pesticide residues in processed foods, 5. 1074 contains a
multitude of false assumptions that would make tolerance decisions
arbitrary and overly restrictive, would inhibit sound science, and
would make the minor use problem even worse.
NFPA is strongly committed to reasonable pesticide tolerance
legislation, but we cannot support the proposals embodied in S.
1074 as introduced. We are prepared to work with the Congress in
fashioning reasonable legislation.
Mr. Chairman, the American people demand and deserve an ade-
quate, wholesome and economical food supply, and this is only pos-
sible with a reasonable, scientifically based pesticide policy.
Thank you.
[The prepared statement of Mr. Guardia follows:]
PREPARED STATEMENT OF DR. ENRIQUE J. GUARDIA
Mr. Chairman and members of the committee, I am Enrique J. Guardia, Vice
President of Scientific Relations for Kraft General Foods, the largest manufacturer
of processed food in the United States. I am testifying today on behalf of the Nation-
al Food Processors Association (NFPA). Accompanying me is Clausen Ely, with the
firm of Covington & Hurling, legal counsel to the Association. We appreciate the
opportunity to appear today and to address the important and timely topic of the
safety of pesticide residues in food.
I hold a Ph.D. in biochemistry, and have served in scientific and research capac-
ities in the food industry for over 25 years. My responsibilities have comprised scien-
tific research, regulatory compliance and quality control, including issues relating to
risk assessment and control of pesticide residues in food.
NFPA is a national trade association representing over 500 companies, including
food processors, and food packaging and equipment manufacturers. NFPA main-
tains three research laboratories, employing over 100 scientific personnel, which
conduct a wide range of important food processing research. NFPA laboratories are
widely recognized as leaders in pesticide residue testing, and NFPA maintains an
extensive pesticide residue data bank.
NFPA maintains active programs to assure that processed foods do not contain
illegal or excessive pesticide residues, to develop pesticide use and residue data nec-
essary for accurate and realistic benefits and exposure assessments, and to promote
Integrated Pest Management (1PM) and other techniques to minimize pesticide use.
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The NFPA Pesticide Screen Program has been widely used in the food industry for
many years for optimum quality procedures for controlling pesticide residues in
food. The emphasis of the Pesticide Screen Program is on measures to assure proper
use of pesticides by growers of crops employed in processed food. The Program in-
cludes regular communication between processors and growers to assure prudent
and legal pesticide use, establishment of procedures for maintenance of accurate
pesticide use records and participation in education programs on proper pesticide
use.
Let me stress at the outset that NFPA recognizes the need for pesticide tolerance
legislation, and we are prepared to work toward enactment of a reasonable toler-
ance bill in this Congress. In January of this year, NFPA announced a comprehen-
sive food safety legislative proposal to improve regulation of pesticide residues in
food. The NFPA proposal builds upon the recommendations of the 1987 National
Academy of Sciences (NAS) Delaney Paradox Report and is consistent with Presi-
dent Bush's food safety plan submitted to Congress last year. The overriding goals of
the NFPA proposal are to establish a consistent and scientifically defensible pesti-
cide safety standard, to simplify and streamline pesticide cancellation and tolerance
procedures, and to mandate national uniformity for tolerances meeting current
safety standards.
NFPA supports the following specific legislative provisions, which will provide a
solid foundation for assuring the availability of safe and beneficial pesticides in the
coming decades.
(1) A uniform negligible risk standard for pesticide residues in both raw and proc-
essed food.
(2) A requirement that EPA employ actual pesticide use and residue data in calcu-
lating dietary exposures.
(3) Continuation of the requirement that EPA conduct a- risk-benefit analysis in
determining whether to issue or revoke a pesticide tolerance.
(4) National uniformity of pesticide tolerances approved by EPA since 1985, with
limited provision for special State tolerances justified by compelling local conditions.
(5) A requirement that EPA adopt CODEX-recommended maximum pesticide resi-
due levels (MRL's) unless there are valid scientific reasons for not doing so.
(6) A pipeline provision that would permit sale of existing stocks of food legally
treated with a pesticide for which the tolerance is subsequently revoked, unless
EPA can establish that the remaining stocks of food pose an unreasonable dietary
risk.
(7) Elimination of the cumbersome and time-consuming adjudicatory hearing re-
quirement in the pesticide cancellation process.
(8) Required periodic-renewal of pesticide registrations and tolerances to assure
continued evidence of pesticide safety.
While we recognize Chairman Kennedy's effort in developing a bill to address pes-
ticide tolerance issues, the bill is inconsistent with many of NFPA's stated objec-
tives and would not advance the public interest.
We support the provisions of the bill that would harmonize the safety standards
for pesticide residues in raw and processed food, that would permit sale of food
treated with a pesticide for which a tolerance is later revoked, and that would
assure an open and timely tolerance setting process. Much of the bill, however, is
contrary to the interests of the food industry and consumers, and is not an improve-
ment over current law. The bill goes far beyond the recommendations of the HAS
and the recognized need to streamline the pesticide tolerance process. The bill
would mandate a rigid and unrealistic negligible risk standard, would unduly limit
EPA's scientific and regulatory discretion, would disrupt the FIFRA reregistration
process and would prohibit EPA from considering any health or consumer benefits
in pesticide tolerance decisions. An important adverse effect of this approach would
be to accelerate the loss of safe and effective minor use pesticidesi which are of par-
ticular importance to our members. On balance, the bill creates many more prob-
lems than it solves, and we can not support it.
We have made it clear that we support a uniform negligible risk `standard for
pesticide residues in raw and processed food, but not at the expense of scientific
reason, regulatory order and consumer welfare. It makes no sense to replace the De-
laney Clause with an equally rigid and arbitrary safety standard, to superimpose a
different tolerance reevaluation schedule on top of the FIFRA reregistration proc-
ess, to abandon consideration of benefits in tolerance decisions, or to impose further
data requirements and cost pressures on minor uses.
Before addressing 5. 1074, I would like to stress several important points. First,
our members are committed to undertake all reasonable efforts to assure that their
products contain no illegal pesticide residues and that pesticide use is reduced to the
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extent feasible, through Integrated Pest Management and other steps. Our surveys
and those of the United States Department of Agriculture (USDA) and other agen-
cies show that farmers carefully limit pesticide use to well below maximum permit-
ted application rates and that pesticides are only applied to the percentage of the
crop for which a real need is demonstrated.
Second, numerous studies conducted by our labs, the Federal Food and Drug Ad-
ministration (FDA) and other agencies have demonstrated that pesticide residues in
processed foods are far below tolerance levels, are significantly reduced from levels
contained in raw ingredients and are ordinarily undetectable. For example, the Cali-
fornia Department of Food and Agriculture conducted extensive surveys-in 1987 and
1988 that showed that over 82 percent of crops grown for processing had no detecta-
ble pesticide residues. Moreover, it is important to bear in mind that the critical
consideration for risk analysis is the level of pesticide residues in food as eaten. For
raw fruits and vegetables, consumers ordinarily undertake preparation, including
washing and trimming, that reduces any pesticide residues prior to consumption.
Third, NFPA supports strong and effective pesticide tolerance laws and allocation
of sufficient resources to permit the Environmental Protection Agency (EPA) and
FDA effectively to implement and enforce those laws.
Finally, there should be no consideration of pesticide tolerance legislation without
serious attention to the potential impact on minor uses. Unfortunately, 5. 1074
would exacerbate, rather than relieve, the minor use problem. The growing loss of
minor use pesticides for fruit and vegetable production poses a serious problem for
the food industry. Minor uses are not economically attractive to the pesticide indus-
try, and there is little incentive for pesticide producers to underwrite the high cost
of defending these uses. The 1988 FIFRA Amendments require that all pesticides
registered prior to 1984 be reregistered over a 9-year period. For reregistration, pes-
ticide producers must develop extensive safety, environmental and residue studies to
support each registered use, and must pay substantial fees to fund EPA's reregistra-
tion program. Because of the costs involved, a growing number of producers are
abandoning minor use registrations, without regard for the relative safety or bene-
fits of those uses.
Two recent examples of the serious dimensions of the minor use problem are the
threatened loss of many valuable uses of the ethylene bisdithiocarbamate (EBDC)
fungicides and of the-insecticide Malathion. The pesticide producers have decided
to abandon support for these minor use registrations to avoid testing costs and, in
the case of some EBDC uses, to assure that all major uses are retained without ex-
ceeding a negligible risk level. These decisions are made without any consideration
of the benefits of the abandoned minor uses to consumers and the agricultural com-
munity.
EPA and USDA released a joint statement on April 15, 1991 regarding the impor-
tance of reregistration of minor uses. The statement stresses that minor use pesti-
cides are of major significance to agricultural production and consumers, that many
fruits and vegetables could not be grown successfully without minor use pesticidesi
and that measures must be adopted to assist in preservation of minor uses. 5. 1074
would undercut the Agencies' efforts and would aggravate the minor use problem by
eliminating consideration of benefits in tolerance decisions, by prescribing rigid and
unduly conservative safety standards and by increasing the costs of supporting
minor use registrations.
With this background, I would like to address several specific features of the bill
that are of great concern to our members. Without substantial improvements in
these aspects of the legislationl the public interest would be better served under
current law.
1. NEGLIGIBLE RISK STANDARD
Although 5. 1074 would eliminate application of the Delaney Clause to pesticide
residues in food, it would impose a prescriptive and highly conservative definition of
negligible risk. This would foreclose consideration of scientific advances and restrict
regulatory flexibility in the same manner as the Delaney Clause. Instead, EPA
should be permitted to take into account all relevant scientific information in
making negligible risk determinations, and arbitrary numerical risk standards
should not be cast in statutory stone.
Under 5. 1074, a negligible, risk for non-threshold pesticides, including those that
cause cancer in man or animals, would be defined as a one in a million lifetime risk,
with a special standard of one in a million divided by 70 for any single year of expo-
sure during the first 5 years of life of an exposed person. EPA also would be re-
quired to use the most conservative risk assessment models and to calculate a sepa-
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rate risk for seven specific age groups of infants and children (e.g., 0 to 1, 1 to 2,
etc.). This rigid definition of negligible risk would preclude EPA from taking into
account biological data on mechanism of action and other relevant scientific infor-
mation. This would squeeze EPA into a regulatory straitjacket and abandon science
in favor of arbitrary limits.
2. DIETARY EXPOSURE CALCULATIONS
Under current law, EPA is free to employ any scientifically defensible exposure
data in making pesticide tolerance decisions. Although EPA often employs conserva-
tive exposure assumptions, it is free to use, and has used, actual pesticide use and
residue data for dietary exposure calculations. By contrast, 5. 1074 would require
EPA to assume that residues occur in 100 percent of commodities for which treat-
ment is legal and at full tolerance levels. Food industry and FDA studies have
shown that these assumptions are false.
5. 1074 would permit calculation of dietary exposure on the basis of the percent-
age of a commodity actually treated under only one narrow exception. EPA would
be required to show that the percentage of food containing residues is not likely to
increase significantly in the subsequent five years, that "the national distribution of
such percent of such food does not vary significantly from the distribution of the
total amount of such food," and that the aggregate risk from all pesticide residues
on the food are negligible. This would establish a virtually insurmountable eviden-
tiary barrier to use of actual crop treatment data. Moreover, the bill would bar use
of actual residue data, in lieu of tolerance levels, under any circumstancesl regard-
less of the quality of available residue data or the difference between actual resi-
dues and the tolerance level.
As noted, there are extensive government and food industry studies on the levels
of pesticide residues in food. The United States Department of Agriculture is cur-
rently undertaking, at Congressional direction and substantial taxpayer expense, a
large survey of pesticide residues in food. This type of information, regardless of its
accuracy and statistical significance, would be rendered useless by 5. 1074.
The worst case exposure assumptions required under 5. 1074 would reduce the hi-
centive for farmers to minimize pesticide use and would precipitate regulatory
action against valuable pesticides for which there are reliable data demonstrating a
negligible exposure risk.
3. BENEFITS
5. 1074 would eliminate any consideration of benefits in pesticide tolerance deci-
sions. We strongly oppose this aspect of the bill. EPA is currently required, in
making pesticide tolerance decisions, to give appropriate consideration to the neces-
sity for the production of any adequate, wholesome and economical food supply.
This provision is fully appropriate and should be retained. There are several impor-
tant reasons why retention of benefits considerations in pesticide tolerance deci-
sions is desirable.
First, EPA is required under the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA) to balance the risks and benefits of pesticide use, and to consider the
impact of registration decisions on the production and prices of agricultural com-
modities. The proposed prohibition of consideration of benefits in pesticide tolerance
decisions is fundamentally inconsistent with FIFRA and would nullify the benefits
feature of FIFRA for all food use pesticides.
Second, food use pesticides provide important benefits for American agriculture
and consumers. Pesticides help make available to United States consumers a wide
range of high quality and affordable food products. Without effective pesticides, food
quality would be reduced and prices increased, with disproportionate adverse impact
on low income consumers. Pesticides enhance agricultural production and income,
and provide support for the international competitiveness of United States food pro-
ducers. Prohibition of benefits assessments in tolerance decisions would harm both
United States agriculture and consumers.
Third, food use pesticides contribute important health benefits that can outweigh
the hypothetical risks attributed to consumption of residues. Pesticides provide
direct health benefits through control of disease-carrying insects, harmful molds
(such as aflatoxin)and other toxins. Pesticides also play an essential role in provid-
ing a wholesome, healthy and nutritious food supply. The Department of Health
and Human Services (HHS), the Surgeon General, other government agencies, and
prominent scientific and medical organizations have increasingly stressed the value
of a balanced and nutritious diet, including ample amounts of fresh fruits and vege-
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tables, in maintaining health and preventing disease. The loss of an important food
use pesticide can decrease crop yield, damage crop quality, increase food costs and
eliminate the availability of certain types of foods. This can have a significant ad-
verse effect on the health and nutrition of consumers. EPA should be required to
take these important health consequences into account in making pesticide toler-
ance decisions. Although pesticide benefits can not be quantified with absolute pre-
cision, there are greater uncertainties in pesticide risk assessments. Moreover, as
noted, risk calculations are based on numerous worst case assumptions.
Finally, consideration of benefits in food regulatory decisions is not unique to pes-
ticide tolerance determinations. Benefits are also integral to FDA's regulation of en-
vironmental contaminants in food. Under section 406 of the FD&C Act, FDA has
authority to set tolerances or action for substances that are required levels in the
production of food or that cannot be avoided under good manufacturing practice. It
is well established that FDA may take into account the benefits of food containing
environmental contaminants, in terms of the likely economic losses from destruc-
tion or unavailability of that food, in fixing tolerances or action levels.
The methodology for negligible risk determinations include multiple uncertainties
and conservative assumptions. Because of these assumptions, a calculated one in a
million lifetime risk is equivalent to an extremely low, or nonexistent, actual risk. It
is thus appropriate for EPA to retain authority to take into account the benefits of
pesticides that pose greater than a hypothetical negligible risk, especially where a
pesticide use itself provides health or nutritional benefits.
4. COORDINATION WITH FIFRA
In 1988, Congress established a comprehensive schedule for reregistration of old
pesticides to assure that they meet modern data requirements. Food use pesticides
are required to be reregistered first, and applicable tolerances are being reevaluated
in conjunction with the reregistration of food use pesticides. The FIFRA reregistra-
tion process is an ambitious, costly and complicated effort that is straining the re-
sources of EPA and the pesticide industry and that is precipitating the loss of valua-
ble food use pesticides that the producers can no longer afford to support. S. 1074
would superimpose upon the FIFRA reregistration requirements an unnecessary
and inconsistent tolerance evaluation scheme and fee structure. This' would impose
further burdens on EPA, pesticide producers and the food industry without any
compensating benefit to the public.
Under Section 4 of 5. 1074, EPA would be required, within one year of the date of
enactment, to evaluate all available data with respect to the safety of each pesticide
tolerance and exemption. Unsafe tolerances or exemptions would be required to be
revoked within one year of such determination. If EPA determined that the avail-
able data were insufficient to make a safety determination, it would be required to
demand new safety studies and to establish a schedule for submission of such stud-
ies that would permit the Agency to make final decisions on 30 percent of tolerances
and exemptions within 2 years of the date of enactment, 60 percent within 4 years,
90 percent within 6 years, and 100 percent within 7 years.
The requirements and timetables for generation of data to support pesticide toler-
ances and exemptions under S. 1074 would be independent of the reregistration re-
quirements under FIFRA. There is no reason to establish separate reevaluation re-
quirements for pesticide registrations and tolerances. Because the tolerance reevalu-
ation requirements under 5. 1074 are inconsistent with the FIFRA reregistration re-
quirements, the bill would interfere with, and unnecessarily complicate, EPA's ad-
ministration of FIFRA. EPA has already indicated that the timetable for pesticide
reregistration will be difficult or impossible to meet. The bill's accelerated schedule
for tolerance reevaluations will exacerbate EPA's burden in accomplishing an order-
ly and rational review of food use pesticides.
5. 1074 would authorize EPA to demand additional tolerance fees, including an
annual maintenance charge, sufficient to cover the Agency's costs in reevaluating
all existing tolerances and exemptions. These fees, on top of FIFRA reregistration
fees, would increase the economic pressures on pesticide producers to abandon safe
and valuable food use pesticides, particularly for minor crops.
5. TOLERANCE UNIFORMITY
S. 1074 fails to address the need for uniform tolerances for pesticides that have
been shown to be safe under the comprehensive data requirements of current EPA
regulations. Permitting different and inconsistent state and local tolerances causes
public fear and confusion, disrupts interstate commerce and undermines EPA's reg-
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ulatory authority. States and local governments should be precluded from issuing
special local tolerances or warning requirements unless they can prove that a differ-
ent standard is justified by compelling local conditions and would not disrupt inter-
state commerce.
A distinguished Advisory Committee to the FDA (the Edwards Committee) issued
a report on May 15th recommending, as an important component of efforts to
strengthen FDA, that steps be taken to preempt additional and conflicting state re-
quirements for all products subject to FDA jurisdiction. The same principle should
apply to EPA regulation of pesticide tolerances for food.
Inconsistent state and local pesticide residue limits, not only disrupt interstate
commerce, but also create barriers to international trade. With the increasing globi-
lization of the food industry and the movement toward uniform food safety stand-
ards in the EC and other regions, the United States can not afford to maintain a
Balkanized pesticide tolerance system.
CONCLUSION
In summary, the bill takes the sensible and long overdue step of eliminating ap-
plication of the Delaney Clause to pesticide residues in processed food. Unfortunate-
ly, this positive feature of the bill is overshadowed by provisions that would make
tolerance regulation more restrictive, would inhibit sound science and would exacer-
bate the minor use problem. NFPA is strongly committed to reasonable pesticide
tolerance legislation, but we cannot support the policies embodied in 5. 1074 as in-
troduced. We are prepared to work with the Congress in fashioning reasonable legis-
lation.
The CHAIRMAN. Thank you very much.
Mr. Gardner, with Grocery Manufacturers of America.
Mr. GARDNER. Thank you, Mr. Chairman.
I am Sherwin Gardner, and I represent the Grocery Manufactur-
ers of America, and 80 year-old national trade association com-
prised of 140 companies that manufacture approximately 85 per-
cent of the packaged foods that are sold in retail stores throughout
the United States, and we do appreciate the opportunity to appear
here today.
Changes in science and technology since 1954, when require-
ments were first established for controlling pesticide residues,
make it entirely appropriate to review and revise section 408 of the
Food and Drug Act to ensure continuation of a high standard of
safety for foods and also to make the process of establishing residue
tolerances more efficient and effective.
The bill would make the much needed change in the Food, Drug
and Cosmetic Act by establishing a negligible risk safety standard
for pesticide residues in both processed and unprocessed foods. The
National Academy of Sciences recommended such a change in its
1987 report regulating pesticides in food.
GMA supports legislation that would adopt the negligible risk
principle recommended by the report, and indeed that principle
has broader application to other provisions of the Food, Drug and
Cosmetic Act.
Our submitted statement comments on several provisions that
are of particular interest to GMA, and I will summarize them very
briefly.
First, there is a need for flexible safety standard. The establish-
ment of a negligible risk standard as the bill proposes is consistent
with the National Academy of Science recommendations. Regretta-
bly, however, the bill does not establish negligible risk in a way
that represents real and meaningful change. In our view the risk
determination provisions of the bill are unduly prescriptive. They
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would replace one form of an inflexible and unscientific standard
the Delaney clause, with another, in which numerical standards
and specific evaluation criteria are prescribed.
Second, there is a need for workable processed food tolerance re-
quirements. This bill appears to require the establishment of a sep-
arate lower tolerance for residues in processed foods than for un-
processed foods. This is inconsistent with the NAS recommendation
for the same single negligible risk standard for processed and un-
processed foods.
Third, there is a need for practical and realistic approaches to
exposure and tolerances. The bill would require EPA to calculate
dietary exposure on the basis that all foods for which a pesticide is
authorized contain residues in amounts equal to the tolerance. This
would be inconsistent with actual practice, and studies have shown
that not all foods grown are treated and also that residues on those
crops that are treated are not present at the full tolerance levels.
Finally, there is a need for national uniformity for pesticide resi-
due controls. Unfortunately, this bill still does not contain much-
needed national uniformity language. GMA believes that any fun-
damental revision in the regulation of pesticide residue tolerances
should be applied uniformly throughout the country. No State
should be permitted to apply a different standard either directly or
indirectly unless it can be shown that due to dietary patterns or
other factors peculiar to a State that the Federal standard does not
adequately protect the citizens of that State.
In conclusion, Mr. Chairman, GMA agrees that the pesticide resi-
due safety provisions of the Food, Drug and Cosmetic Act need to
be modernized to incorporate contemporary scientific standards
and to increase the efficiency of the tolerance-setting process. We
regret, however, that we cannot support this bill as the vehicle to
accomplish that change.
We are, however, ready and willing to work with the committee
to fashion a bill that would preserve and enhance the safety of the
American food supply and better serve the needs of both the food
industry and the general public.
Thank you.
[The prepared statement of Mr. Gardner follows:]
PREPARED STATEMENT OF SHERWIN GARDNER
Mr. Chairman and members of the Committee on Labor and Human Resources, I
am Sherwin Gardner, Senior Vice President for Science and Technology of the Gro-
cery Manufacturers of America, Inc. (GMA). GMA is an 80 year old national trade
association comprised of 140 companies which manufacture approximately 85 per-
cent of the packaged foods as well as nonfood products sold in retail stores through-
out the United States.
GMA has reviewed with great interest the provisions of 5. 1074, the Safety of Pes-
ticides in Food Act of 1991. This bill is patterned after similar legislation, 5. 722,
introduced in the last Congress. Indeed, since 1985, this bill represents the fourth
introduction of major legislation intended to bring about needed change in the re-
quirements for regulating the safety of pesticide residues in foods. We recognize ef-
forts in developing these bills and we have seen a narrowing of issues in some areas.
Nevertheless, major differences unfortunately remain on important provisions.
The Miller Pesticide Amendments of 1954, which added section 408 to the Food,
Drug and Cosmetic Act, constituted a landmark in the history of food regulation.
They represented the first requirements for premarket approval of substances found
in the food supply, and provided strong assurance to the American public for more
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than 30 years that pesticide residues in or on food have not represented a signifi-
cant risk to health.
Notwithstanding this record of consumer protection, changes in science and tech-
nology since 1954 make it entirely appropriate to review and revise section 408 to
ensure continuation of a high standard of safety, and also to make the process of
establishing residue tolerances more efficient and effective.
In this regard, this bill would make a much needed change in the Federal Food,
Drug and Cosmetic Act by establishing a negligible risk safety standard for pesticide
residues in both processed and unprocessed foods. The National Academy of Sci-
ences recommended such a change in its 1987 report "Regulating Pesticides in
Food." GMA supports legislation that would adopt the negligible risk principle rec-
ommended by the report. Indeed, GMA believes that this negligible risk princip]e
also should be adapted for the other Delaney Clause provisions of the Food Drug
and Cosmetic Act.
As noted, 5. 1074 has narrowed some of the issues. For example, it recognizes the
need for a delay in the marketing pipeline for foods when a pesticide residue toler-
ance is changed or revoked.
Thus, in GMA's view, the bill recognizes some important principles of safety and
process. Although we continue to agree that changes in the law are necessary to
improve the effectiveness and efficiency of the pesticide residue safety process, we
believe that this bill does not present a workable solution to that objective.
Today we wish to focus our comments on a few provisions that are of principal
interest to GMA; specifically:
the need for scientifically defensible and workable safety standards;
the need for a single standard for processed and non-pro~essed food tolerances;
the need for a practical and realistic approach to exposure and tolerances; and
the need for national uniformity for pesticide residue controls.
NEGLIGIBLE RISK STANDARD
The bill would establish a negligible risk standard as the basis for establishing
safe pesticide residue levels in foods. This approach is consistent with the findings
and recommendations of two National Academy of Science reports one on risk as-
sessment, issued in March, 1983, and the other on regulating pesticide residues in
food, issued in May, 1987.
We are deeply concerned, however, that 5. 1074 does not establish negligible risk
in a way that represents real and meaningful change. In our view, the risk determi-
nation provisions of the bill are unduly prescriptive. They would replace one form of
an inflexible and unscientific standard, the Delaney clause of section 409, with an-
other, in which numerical standards and criteria are prescribed. Further, they
would unnecessarily foreclose the consideration of new scientific knowledge or un-
foreseen events in the production of food.
The NAS report recognized that the Environmental Protection Agency has adopt-
ed and is applying conservative, contemporary scientific standards for pesticide resi-
due testing and risk assessment. The application of improved scientific methods
should continue to be left to the discretion of the agency, and driven by future scien-
tific development; legislation should not prescribe specific numerical standards nor
methods of scientific evaluation.
In addition, 5. 1074 fails to provide for consideration of health, nutrition and
other consumer benefits in determining whether a tolerance should be permitted for
a pesticide in food products. Instead, the legislation should retain the long standing
recognition of benefits in the tolerance determination process.
PROCESSED FOOD TOLERANCES
The bill appears to require the establishment of a separate, lower tolerance for
residues in processed foods than unprocessed foods. Information demonstrating "the
lowest level that occurs if the residue has been removed to the extent possible in
accord with good manufacturing practice" is required for petitions to establish a tol-
erance. This is inconsistent with the HAS recommendation for the same, single neg-
ligible risk standard for both processed and unprocessed foods, and would impose
additional regulatory burdens on EPA and FDA.
We believe the current provisions of section 402(a)(2), commonly referred to as the
"pass through provision", should be retained. This requires that residues in proc-
essed foods shall be removed to the extent possible with good manufacturing prac-
tices and must not concentrate to a level greater than that approved for the raw
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agricultural commodity. In this way, both processed and unprocessed foods would be
subject to the same negligible risk standard.
EXPOSURE AND TOLERANCES
In determining what tolerance to establish, the bill would require EPA to calcu-
late dietary exposure on the basis that all food for which the pesticide is authorized
contains residues in amounts equal to the tolerance. This would be inconsistent with
actual practice; studies have shown that not all foods grown are treated, and that
residues on those crops that are treated are not at the full tolerance levels.
Alternatively, the bill would permit the calculation of exposure on the basis of
less than 100 percent crop treatment. However, this could only occur where reliable,
statistically valid data could forecast future crop treatment and distribution, and if
the aggregate risks of all pesticide residues on the food are negligible. These condi-
tions would be virtually impossible to satisfy.
In short, these exposure requirements are unduly conservative and would result
in grossly exaggerated and invalid risk projections.
NATIONAL UNIFORMITY
Unfortunately, this new bill still does not contain much needed national uniformi-
ty language. GMA believes that any fundamental revision in the regulation of pesti-
cide residue tolerances should be applied uniformly throughout the country. The bill
provides that the setting of pesticide residue tolerances be conducted in in open and
efficient procedure. It also requires that EPA reevaluate all existing tolerances ac-
cording to updated scientific standards. Accordingly, once a Federal pesticide resi-
due determination is made, that Federal standard should apply uniformly. No state
should be permitted to apply a different standard, either directly or indirectly
through warning requirements, unless it can be shown that due to dietary patterns
or other factors peculiar to a particular state, that the federal standard does not
adequately protect the citizens of that State.
CONCLUSION
In conclusion Mr. Chairman, GMA agrees that the pesticide residue safety provi-
sions of the Food, Drug and Cosmetic Act need to be modernized to incorporate con-
temporary scientific standards and to increase the efficiency of the tolerance setting
process. We regret, however, that we cannot support this bill as the vehicle to ac-
complish that change:
the negligible risk standards of the bill are overly prescriptive, and the exposure
and tolerance setting requirements are unworkable. In addition, the bill lacks provi-
sions to establish national uniformity for residue tolerances that meet new scientific
standards.
We are ready and willing to work with the Committee to fashion a bill that would
preserve and enhance the safety of the American food supply and better serve the
needs of both the food industry and the general public.
Thank you for inviting GMA to participate in this hearing.
The CHAIRMAN. Thank you.
Mr. Vroom.
Mr. VROOM. Thank you, Mr. Chairman.
I believe that you and your committee and NACA's members
share three common concerns as we look at this issue of food safety
and Federal legislation to address it.
First, we all eat the food grown, with the help of my industry's
crop protection products, and we share your concern as individuals
and members of our industry about the safety of our food and the
continued ability of our industry and our farmer customers and
Federal regulators and the food industry itself to continue to im-
prove an already safe food supply.
I personally am the father of two young sons, and have that indi-
vidual concern that I take home with me every night. I am also
part of a family farming operation in Illinois that has a long record
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of safe and effective use of pesticides, so I feel like I have a perspec-
tive from that side as well.
Second, I think there is room for improvement in the current
system both from the legislative and regulatory standpoint.
And third, we believe that the continued safety of America's food
supply is of vital importance, and we are prepared to work with
this Congress to develop and implement fair and appropriate and
effective legislation.
However, we like many others that you have heard from and
others who will submit written testimony and input, are not in a
position to support S. 1074. We don't see it as a rational or appro-
priate means to continue to improve an already safe food supply.
Many of the provisions which we believe cannot be fixed in the
bill have already been identified as unacceptable by a wide cross-
section of the public including farmers and commodity groups, food
processors and distributors, and scientists from both the public and
private sectors.
I'd like to reduce my additional thoughts here to three areas in
the oral statement and appreciate the fact that you will include
our full written testimony in the record.
One point would be to address the rigid negligible risk standard
that is incorporated into S. 1074; second, the failure of the bill to
consider benefits; and third, the unrealistic risk assumptions.
The NAS report, the Delaney paradox, correctly concluded that
strict requirements of the Delaney clause actually interfere with
measures to reduce cancer risks and block introduction of safer
crop protection products. Instead, the report recommended that the
Delaney clause be replaced with a de minimis or negligible risk
standard. While this bill that you have introduced purports to use
a negligible risk standard, we believe that it instead prescribes
methods of calculation which would make negligible risk essential-
ly zero risk standard. Therefore we think that that is a distortion
of the NAS concept of negligible risk.
Further, in the NRS area, we think that prescription of the
"solid bright line" of 10 to the minus 6th in the bill's language
versus a somewhat more flexible, narrative negligible risk standard
is also a flaw in the bill.
In addition, to make a negligible risk determination, EPA under
your bill would be required to take into account the special sensi-
tivities of individuals. We contend that this is part of the current
regulatory process and is within the authorization of current law,
and to the extent that we can find and you can find and the regula-
tors can find scientific evidence that improvements are needed in
the current system, the membership of NACA will support the
system changes which we believe can be made via the regulatory
channels.
S. 1074 also requires a separate negligible risk calculation for
seven specific age groups of infants and children. Yet we are not
acquainted with any scientific evidence that would support those
particular categories. We think that needs further work and explo-
ration.
I think that provision and the whole area may be premature at
this point because of the next NAS report on pesticides in the diet
of infants and children that Congress has requested, as yet to be
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released but is coming very soon, and would agree with the obser-
vations of former Surgeon General Koop, who recently said that to
preempt this study at this point in its final hours of preparation
would be unwise.
The provision that you've got here under negligible risk standard
is especially premature given the fact that EPA currently does ac-
count for special groups and again is looking, I think, in coopera-
tion with industry for ways to improve that existing system.
The elimination of benefits in S. 1074, we also have very grave
concerns about. First of all, we think it would serve to further
create and expand the disharmony between current Food, Drug
and Cosmetic Act standards and FIFRA and exacerbate those in-
consistencies.
Theoretically under your bill a pesticide that today could get a
registration because benefits are used as part of the equation that
might outweigh a known risk that is calculated by the agency and
the regulators could not get on the market under the provisions of
S. 1074, and we believe that your rigid zero risk, negligible risk
standard really creates the potential and likelihood that safer pes-
ticides might be more difficult to get onto the marketplace.
Thank you.
[The prepared statement of Mr. Vroom follows:]
PREPARED STATEMENT OF JAY J. VROOM
Mr. Chairman and members of the committee, on behalf of NACA and its
member companies, I am pleased to have this opportunity to comment on S. 1074,
the "Safety of pesticides in Food Act of 1991."
It is obvious that the authors of 5. 1074 have expended a great deal of effort in
responding to shortcomings, both real and imagined, with the current system of reg-
ulating the permissible level of pesticide residues in America's food supply. NACA's
members are this Nation's leading manufacturers of crop protection chemicals. We
too eat the food grown with the help of our productsl and we share your concern
about the safety of our food.
However, 5. 1074 goes far beyond what is needed. Indeed, is difficult to suggest
amendments that would fix this bill. Accordingly, NACA must oppose 5. 1074. In-
stead, NACA proposes that we start over with a new bill which addresses attainable
goals, which is based on sound science and utilizes realistic risk assumptions, and
which is sensitive to both agriculture and the broader public policy issues involved.
Many of the provisions in 5. 1074 which NACA believes cannot be fixed have al-
ready been identified as unacceptable by a wide cross-section of the public, including
farmers, commodity groups, food processors and distributors, and scientists from
both the public and private sectors. The flaws in 5. 1074 include:
the confusing, rigid and extreme assumptions used in calculating risk assessment;
the bill's failure to consider the benefits from the use of pesticides (which will
have a devastating effect on agriculture);
the misguided attempt to regulate all inert ingredients, metabolites and degrada-
tion products;
deadlines which are not achievable; and
the many damaging inconsistencies between 5. 1074 and current law and practice.
There are other flaws which you and your subcommittee no doubt will hear a
great deal more about during and after these hearings. However, do not misinter-
pret NACA's objections to 5. 1074. We believe that the continued safety of Ameri-
ca's food supply is of vital importancel and we are prepared to work with Congress
to develop and implement fair, appropriate and effective legislation. We simply do
not believe that 5. 1074 is a rational or appropriate means to continue to assure a
safe food supply. In that regard, we shall now discuss in detail the shortcomings of
the proposed legislation.
47-693 0 - 91 - 5
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THE NEGLIGIBLE RISK STANDARD
S. 1074 would replace existing FFDCA standards for tolerance-setting with a new
"negligible risk" standard applicable to both raw and processed food. Currently,
FFDCA Section 408 (raw commodities) encompasses a risk-benefit analysis (by re-
quiring consideration of "the necessity for the production of an adequate, whole-
some and economical food supply), for setting pesticide residues at a level "neces-
sary to protect the public health." Under Section 409, the Delaney Clause bars carci-
nogenic pesticide residues which concentrate in processed foods. The effect of these
two provisions has been discussed, and appropriately criticized, in the National
Academy of Sciences' (NAS) report, Regulating Pesticides in Foods: The Delaney
Paradox. That report concluded that the strict requirements of the Delaney Clause
actually interfere with measures to reduce cancer risks, and block safer product in-
troduction. The report recommended that the Delaney Clause be replaced with a
"de minimis" or "negligible risk" standard.
EPA currently sets tolerance levels under Section 409 by using a "de minimis"
standard. That standard is described in detail in EPA's October 19,1988 policy,
issued in response to the 1987 HAS recommendations, and in their Final Order of
February 15, 1991, issued in response to a petition to revoke certain tolerances.
EPA's use of that standard results in a workable and logical interpretation of the
Delaney Clause, and NACA supports that approach. While S. 1074 purports to use a
"negligible risk standard," the bill prescribes methods of calculation which would
make "negligible risk" essentially a "zero risk" standard. Therefore, rather than
leaving room for discretion to define risk as truly negligible, the bill cleverly defines
negligible risk with a no risk standard. This is a distortion of the concept of "negli-
gible risk."
5. 1074 defines a risk as negligible if "exposure to a residue is reasonably certain
to cause no harm to human health." In addition, the bill mandates that risk from
exposure to residues from non-threshold pesticides is negligible only if the lifetime
risk were 1-in-i million, with a special standard of i-in-i million divided by 70 for
any single year of exposure during the first five years of life of an exposed person.
Neither the HAS nor any of the parties involved in this regulatory process endorses
the concept of a fixed numerical value being stipulated in a statute. In testimony
before the House Agriculture Subcommittee in 1988, the Executive Director of the
HAS Board on Agriculture testified, in part, that:
The NAS committee discussed at virtually every meeting whether to recommend
a quantitative benchmark for negligible risk as part of its definition of this impor-
tant concept. The committee was both sensitive and well aware of valid arguments
both for and against specifying a quantitative benchmark in the definition of negli-
gible risk. In the end, the committee was persuaded that quantitative risk estimates
of oncogenic risks were too fragile and changeable to either assert that risks below a
certain level are truly neghgible"or that risks above the "negligible" level indeed
pose a significant risk of cancer in man. Such judgments, in the committee's view,
can only be made on a case-by-case basis following a thorough review of the com-
plete toxicological database available on a particular chemical.
The reluctance to fix a numerical value for negligible risk is prudent and under-
standable knowledge is rapidly advancing in the science bearing on risk assessment,
and society needs the flexibility to modify its perception as conditions change, and
as views of acceptable risk and the ways to measure it change.
For threshold pesticides, negligible risk is determined using a "no observable
effect level" ("NOEL"). The NOEL is the level of exposure at which reliable experi-
mental data, derived from actual exposure to pesticides, show no adverse effects in
experimental animals. While a safety factor of tenfold has been recognized among
scientific experts as adequate for establishing a safe level of human exposure to cho-
linesterase pesticides, 5. 1074 instead prescribes a 1/100th NOEL (i.e. the NOEL di-
vided by 100) for all risks. A 1/100th NOEL has justification because it provides an
extra measure of prudence. For that reason, NACA continues to support the use of
1/100th NOEL for arriving at an Acceptable Daily Intake (ADI). However, when
taken in conjunction with the conservative risk assessment model requirements
elsewhere in the bill, this level is unreasonably high.
5. 1074 further calls for the use of "conservative" risk assessment models in deter-
mining negligible risk, even though such conservative mathematical risk assessment
models are not necessarily the most accurate. In making the negligible risk determi-
nation, EPA would also be required to take into account the special sensitivities of
individuals. No national legislative scheme can be effective if it attempts to set
standard for the entire population based on the exceptional needs of a few. This pro-
vision alone would bury S. 1074 of its own weight.
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The bill does not stop there. It also requires a separate negligible risk calculation
for seven specific age groups of infants and children. This provision is premature
because the NAS report on pesticides in the diets of infants and children has not yet
been released. It would be highly inappropriate at this time to mandate by legisla-
tion such specific calculations just months before the results of this important study
are made known.
That is not to say that the diets of our children are not currently being considered
in the regulatory process. EPA currently accounts for the needs of these groups in
setting tolerances. When reviewing petitions to establish a tolerance, EPA considers
the special consumption patterns of various age groups. S. 1074, however, has aimed
this provision well beyond the necessary mark. Carving such a detailed data re-
quirement scheme in stone only a few months in advance of the very study which
will verify the need for such regulation is not legislatively responsible. NACA con-
tinues to support the protection of identifiable groups with quantifiable exposure
differences. However, we support such legislation only after release and review of
the NAS report. In the meantime, this bill's proposed use of conservative assess-
ment models, in conjunction with the truly low definition of negligible risk, offers
protection enough to any conceivable population group.
ELIMINATION OF "BENEFITS" FROM CONSIDERATION
EPA is currently required to consider both the risks and benefits of pesticide use
in registering pesticides under FIFRA. Benefits of a pesticide may also be considered
in granting raw commodity and processed food tolerances under FFDCA. Only the
Delaney Clause implicitly prohibits consideration of pesticide benefits for carcino-
gens. S. 1074, however, eliminates all consideration of benefits in setting tolerances
in all foods. Rather than resolving the inconsistency between the two statutes
prompted by the Delaney Clause, the Act actually exacerbates that inconsistency.
Under 5. 1074, a pesticide could receive a F1FRA registration because the benefits of
its use are such that they outweigh a known risk. Yet that same pesticide may fail
to receive a tolerance because the risk exceeds the (now zero-level) negligible risk
standard, and because the benefits are not considered. The incongruous result is
that a pesticide could lawfully be sold and applied under FIFRA, but the treated
produce or crop would be illegal under FFDCA. By eliminating all consideration of
benefits under FFDCA, S. 1074 has merely substituted one paradox for another.
But S. 1074 has an even more basic bailing. Consideration of pesticide benefits,
along with their risks, is good public policy and an appropriate consideration for
making regulatory decisions on pesticides. In the context of FFDCA, decisions on
permissible pesticide residues are directly related to the ability of agriculture to pro-
vide inexpensive and quality food, and to the ability of others to provide clean and
healthy eating, working and living conditions. However, in no case should a benefits
analysis allow an otherwise dangerous product to reach, or stay on, the market. The
key is balance and informed, rational decision making, concepts which this bill's si-
lence on the benefits issue will frustrate.
The benefits from use of pesticides in assuring a safe, wholesome and abundant
food supply are important, relevant factors for consideration. They include:
Pesticides provide America's farmers with a strategic resource in the battle to
control pests that would otherwise cause widespread and significant damage to
almost all crops grown in the United States. They allow for selective control of
harmful insects, nematodes, weeds, rodents and plant pathogens. In the pest man-
agement context, insecticides are the only practical control measure for insect pest
populations approaching or at infestation levels that will cause major crop damage
or health risks. They have rapid curative action, offer a wide variety of uses and
methods of application, are low in cost, and are associated with substantial labor
savings to growers.
Pesticides lead to increased availability, lower prices, and improved quality of
commodities, especially fruits and vegetables. At a time when malnutrition and
hunger are no longer solely remote problems of the third world, this benefit is of
increasing importance. The availability of a wide variety of food all year is an in-
valuable benefit to the public.
Yet even these facts do not tell the real benefits from use of pesticides. Protection
from the devastation of entire local and regional crop loss is available from judi-
cious use of crop protection chemicals. In many areas and on many crops, pesticides
are the only means to control pests whose presence would otherwise prohibit pro-
duction of certain crops. Without these tools to protect crops, many individual farms
may fail. For example, most fruits and vegetables simply cannot be produced in
most parts of the eastern and southeastern United States without insecticides and
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fungicides. This fact was even acknowledged by the NAS Alternative Agriculture
study, and by an eminent organic farmer (Ward Sinclare), who stated that he can't
produce organic potatoes on his farm in Pennsylvania because he can't control the
Colorado Potato Beetle without insecticides.
In current practice, EPA, correctly, does not place primary importance on benefits
analysis. According to the March 7, 1991 GAO report on EPA's use of the benefits
assessment, the agency "bases initial tolerance and registration decisions primarily
on perceived risks to health and on environmental considerations....the principal
role of benefit analysis is to inform EPA decision makers during special review
about the extent of the benefits associated with a specific pesticide's use." However,
by eliminating these important considerations, the agency will be required to make
tolerance and registration decisions in a vacuum.
EXPOSURE ASSUMPTIONS
EPA is free under current law to employ any reasonable and scientifically defen-
sible exposure data in making pesticide tolerance decisions. Although EPA often
employs conservative exposure assumptions, it is free to, and has used, actual resi-
due data for exposure calculations where reliable and accurate information is avail-
able. S. 1074 would virtually prohibit use of such data.
The risk posed by a substance depends both on its affect and exposure to it. In
essence, no exposure means no risk. S. 1074 not only assumes that there is always
exposure to a pesticide-a bold and inaccurate assumption-but also assumes the
most extreme case. In calculating exposure to a pesticide S. 1074 requires EPA to
make the following assumptions and considerations:
The residue occurs in 100 percent of commodities for which treatment is legal,
All crops have the maximum permitted residue,
The residue is consumed for a lifetime,
All other dietary exposures, including drinking water, are included,
Consumption by seven different groups of infants and children, and
Consumption by individuals and groups with special food consumption patterns.
Even for those with little knowledge of pesticide risks, these assumptions are
clearly preposterous. No national crop ever tested, much less all authorized crops,
has ever contained the maximum permitted residue. Further, no pesticide has been
used for 70 years. As newer, safer and more effective products are introduced, older
products are removed and replace. Yet, S. 1074 requires EPA to establish tolerances
based on these rigid and extreme assumptions and considerations. By making these
assumptions and considerations mandatory, rather than merely permissiblel EPA is
required to ignore reality.
To blunt criticism of its outrageous and unreasonable exposure calculations, S.
1074 contains a narrow exception to permit use of actual exposure data. Under the
bill, EPA would be allowed to calculate dietary exposure on the basis of the percent-
age of the commodity actually treated only where it had reliable, statistically signif-
icant data on the percentage of food containing residues, and could show (1) that
such percent is not likely to increase significantly in the subsequent five years, (2)
that "the national distribution of such percent of such food...does not vary signifi-
cantly from the distribution of the total amount of that food," and (3) that the ag-
gregate risk from all pesticide residue on the food are negligible. This exception
calls for data that does not exist-making it the "no-exception, exception." Given
the wide disparity of pests, pesticide usage, and marketing of agricultural commod-
ities, it would seem that few foods with residues are distributed evenly throughout
the Nation. Showing that the percent treated would not increase in the next 5 years
is an impossible prediction. These requirements would establish a virtually insur-
mountable evidentiary barrier.
INERT INGREDIENT TOLERANCE REQUIREMENTS
In practice, most inert ingredients are currently subject to tolerance exemptions,
although EPA is reviewing inert ingredients which pose a toxicological concern and
using data call-in procedures to determine conditions of safe use. By amending the
definition of a pesticide chemical to include active and inert ingredients, 5. 1074 will
now require manufacturers to seek and obtain a tolerance or exemption for each
inert ingredient. This is required, notwithstanding the fact that many of these prod-
ucts are currently either "generally recognized as safe," ("GRAS"), or have been
granted exemptions. Nevertheless, under this bill EPA will be forced to review hun-
dreds of inert ingredients, and possibly thousands of toxicity studies, when it could
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and should be focusing its attention on new pesticide chemicals, re-registration, new
active ingredients, or those with the most toxic inert ingredients.
To complicate mailers, EPA would be required to review all existing tolerances
and exemptions, including inerts, within one year. And because the inerts would
have to meet the negligible risk standard, new tolerances and/or exemptions would
have to be established for virtually all inert ingredients. NACA believes that risks
associated with inert ingredients need to be monitored. However, the scheme pro-
posed by this bill would merely create chaos. The reevaluation of all inerts, without
regard to how much could be present or as to toxicity, simply does not make sense.
PRACTICAL METHODS OF ANALYSIS
NACA strongly supports the proposition that FDA should have the necessary ana-
lytical tools to be able to quickly and accurately enforce the FFDCA. Currently, a
tolerance will not be granted unless the petitioner submits a proposed method for
analysis, and EPA has approved that method. This bill, however, insists that manu-
facturers develop only one type of analytical method. S. 1074 requires a "practical
method of analysis," which is later defined as a multi-residue" method that can be
performed on a routine basis as part of surveillance and compliance sampling. What
the drafters apparently have failed to grasp is that some molecules and products are
unique, and either do not lend themselves to such methods, or cannot be detected by
such methods. In its zeal to consolidate residue monitoring, S. 1074 will instead
hamstring FDA. Rather than simply mandate one type of test, NACA supports resi-
due monitoring requirements where the agency would get the most-in terms of ac-
curacy and quantity- for its money.
The only exception is that EPA would be authorized to permit a non-practical
method of analysis only if a practical method was not available. This determination
would have to be reevaluated every two years. This too, is a very limited exception.
Multi-residue methods, when available and practical to use, can represent savings of
time and effort in residue monitoring. However, this inflexible requirement will ac-
tually result in more expensive, less accurate and less efficient monitoring, because
not all residues monitored in a multi-residue test are present in each food or crop
tested. In such a case, the multi-residue method would .be wasteful. EPA must be
given the discretion to work with the petitioner to develop tests deemed appropriate
by the Agency. Consultation with FDA would be only as needed.
S. 1074 simply misses the point on routine residue monitoring. In reality, not all
pesticide chemical residues need to be routinely monitored. Even setting aside the
administrative burden this bill would place on FDA, usage patterns of pesticides do
not require multi-residue methods. It would be pointless to routinely monitor for
substances where there is no reasonable expectation for residues and a tolerance is
set at the sensitivity of the analytical method.
PHASED RISK REDUCTION
Currently, there is no statutory requirement under FFDCA that EPA review ex-
isting tolerances. However, under FIFRA, EPA is involved in a massive reevaluation
of all registrations. That process includes a review of tolerances for food use pesti-
cides.
Nevertheless, with the objective of expediting review of all existing tolerances to
bring them in line with the new "negligible risk" standard, 5. 1074 requires EPA to
reevaluate existing data regarding the safety of each and every tolerance and ex-
emption. Within 1 year, EPA must determine whether existing data is sufficient to
make that determination. If EPA can't determine that the pesticide is "safe," its
tolerance will be revoked. If EPA determines that it needs more data, it can then
demand new safety studies. Under this scenario, EPA must have completed its
review of all such tolerances within 7 years.
These proposed requirements are intended to be separate and distinct from the
F1FRA re-registration process. Assuming that this redundant review is even neces-
sary (which NACA does not believe), absolutely no attempt has been made to coordi-
nate the two processes. NACA can see no reason to establish separate reevaluation
requirements for pesticide tolerances and registrations. In fact, FIFRA re-registra-
tion contemplates review of each pesticide's tolerance. We believe that S. 1074
would interfere with FIFRA's re-registration, which is already behind schedule and
overburdened by inadequate staff and insufficient funds. EPA has already testified
in other hearings that they believe the deadlines established in F1FRA `88 cannot be
met. Because this additional burden on EPA will only serve to exacerbate those
problems, NACA opposes this provision in its entirety.
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DATA CALL-IN
In view of the many complexities and potential for statutory conflicts that it in-
troduces, it is a mystery why S. 1074 grants EPA data call-in authority under
FFDCA. This is especially true since EPA already has broad existing authority to
require the same data under F1FRA.
Scattered throughout the bill, but particularly in Section 408(c), as amended, the
bill gives EPA sweeping power to require new health and safety data in support of
both new and existing tolerances and exemptions. Similar to FIFRA, there are few
limits on the type and quantity of testing requirements. Unlike FIFRA, however,
any failure to submit the data on time (except for "extraordinary circumstances"),
will result in automatic revocation of the tolerance or exemption. This penalty
seems unreasonably harsh, and is unrelated to the severity of the omission.
Also, unlike F1FRA, a hearing on the merits of the data call-in and deadlines
would be available only after the tolerance or exemption is revoked. Since the cost
of data development and potential for legitimate controversy are so great, 5. 1074
goes far beyond what is needed, or indeed, reasonable, in granting EPA both the
authority to require data, and the procedural hammer to argue the equity and law-
fulness of its demand after-the-fact.
DATA CONFIDENTIALITY
5. 1074 utterly fails to protect confidential information from public disclosure,
both before and after EPA acts on a tolerance or exemption. While purportedly pro-
viding "limited public access," even a cursory reading of the "Disclosure" paragraph
reveals that the confidentiality provisions are more accurately described as "limited
confidential treatment."
Currently, FFDCA prohibits public disclosure of data supporting tolerances until
after the agency has taken final action on a petition. This is for good reason. Manu-
facturers spend millions of dollars developing products, conducting in-house safety
tests, and conducting EPA required safety and efficacy testing. Until this data be-
comes a product and receives a patent, or until the manufacturer becomes entitled
to data compensation under FIFRA, this information is arguably the most sensitive
jnformation maintained by the manufacturer.
In practice, data supporting both tolerance and registration petitions are submit-
ted under FIFRA. F1FRA limits public disclosure, at any time, of certain confiden-
tial business information, bars disclosure of registration data to competitors, and
provides for use exclusivity and gives compensation for certain data. Current prac-
tice adequately protects the manufacturer, and provides EPA with all of the infor-
mation it needs to conduct its review of the product.
S. 1074 renders current protection under F1FRA meaningless, and would make it
impossible for manufacturers to keep confidential trade secrets and business infor-
mation out of the public domain. Under this exception-riddled provision, data sub-
mitted in support of a petition would be entitled to confidential treatment for only
45 days-until the Administrator publishes the initial Notice that a petition to es-
tablish a tolerance has been filed. Thereafter, the Administrator is required to pub-
lish a summary of the safety data submitted in support of the petition. In addition,
under Section 408(g), the Administrator shall provide. . "public access to health and
safety data that are submitted or cited in support of such petition." Of course,
anyone requesting that data must attest that they are not a competitor. However, it
does not take much foresight to envision the following scenario. A person wishes to
contest the data supporting a petition, and he files a lawsuit seeking to enjoin issu-
ance of a regulation establishing a tolerance. In the process, the information in the
petition becomes public. And while the person seeking access to the data prior to
EPA action must state that he will not "intentionally or recklessly" violate that
subsection, there is no protection should that person ever negligently disclose confi-
dential information. Therefore, the affirmation is meaningless; this type of protec-
tion is no protection.
Furthermore, data in support of a petition may be released before agency action
on the petition to "either House of Congress or any committee or subcommittee
thereof to the extent of matter within the jurisdiction of the committee or subcom-
mittee." Mr. Chairman, we can imagine absolutely no justification for this intrusion
into the exclusive decision making domain of an agency prior to agency action.
Indeed, this provision does not even limit the information to members of the com-
mittee or subcommittee. Presumably, staff members, who are not bound by the con-
fidentiality provisions of proposed Section 408(g)2, would also have access to this in-
formation. This provision is understandably unacceptable.
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On a more pragmatic level, disclosure of such data (whether before or after final
agency action on the petition), undercuts both the data compensation and confiden-
tiality provisions of F1FRA. Millions of dollars in research and development depend
on the protection provided under F1FRA. Without the guarantee of exclusive use,
companies would not risk the costs associated with the development of any new
product. The effect on safer pesticides, minor use, and eventually all products,
would be devastating.
PROCEDURES FOR ESTABLISHING OR MODIFYING A TOLERANCE
The proposed requirements of S. 1074 for establishing a tolerance are unworkable.
FFDCA tolerance-setting will now be subject to the imprecision, delay and frustra-
tion known as "notice and comment rulemaking." Such rulemaking typically suffers
from lack of agency accountability, indifferent rulemaking records, and arbitrary re-
sults. Taken in combination with (1) provisions for public assess to supporting data,
(2) elimination of the input of the NAS scientific advisory committee, and (3) the
rights of persons with no direct interest to submit comments and participate in the
proceeding, the proposed procedure will quickly cause the administrative wheels to
grind to a halt. Even those petitions which would be entitled to priority under the
bill are given no procedural advantage. Presumably, the drafters were aware of the
certain delays, as they have given the agency fully three times as long to make its
decision establishing a tolerance. Manufacturers have invested heavily in research
and development for new products. To subject them to such long delays gives them
no incentive to bring new products to market. Understandably, these provisions are
also unacceptable.
The provisions of S. 1074 for revocation/modification of a tolerance suffer the
same procedural flaws. Additional problems involve the right of any citizen to peti-
tion to have a tolerance revoked, revocation for failure to pay maintenance fees, and
the revocation of existing residue tolerances without adequate opportunity to defend
their safety.
JUDICIAL REVIEW
5. 1074 contains major deficiencies in its judicial review provisions. Making objec-
tions and requesting a hearing would not be required as a prerequisite to obtaining
judicial review of action on a petition. In fact, a person whose petition was denied
would not even be entitled to file objections or obtain an evidentiary hearing before
the denial becomes final. Additionally, the right to obtain judicial review is substan-
tially enlarged by allowing any person who may be adversely effected to seek judi-
cial review. This, in conjunction with new provisions providing attorney and expert
witness fees (which may be substantial in such technical cases) will no doubt encour-
age frivolous, time consuming and expensive litigation.
However, the most unusual provision regarding judicial review is the inexplicable
shift of the initial burden of proof, typically on the petitioner, to the agency. This
"guilty until proven innocent" approach is fraught with several practical, and po-
tentially legal, pitfalls. For example, the agency may well find itself so inundated
with challenges from disinterested third parties that it will be unable to carry out
its administrative functions in a timely manner. Placing the initial burden of proof
to justify its action only encourages litigation. A petitioner is able to rely on a large-
ly undeveloped administrative record, because there is no provision for an evidentia-
ry hearing prior to appeal. In addition, the person who originally sought the peti-
tion is held captive to a cumbersome judicial process, and products which may have
been a tremendous benefit to production agriculture will be lost. At the very least,
the cost of litigation for the agency in terms of time, money and energy will be sub-
stantial.
It is difficult to see why the issuance, amendment or revocation of tolerances
should be judicially challengeable only after both formal and informal rulemaking,
while petition denials could be the subject to direct judicial review, without opportu-
nity to develop or supplement the administrative record, or without consideration of
the views of other interested persons under either formal or informal rulemaking.
PIPELINE PROVISION
It is true that FFDCA currently does not contain an express pipeline provision
allowing treated crops to "move through the system" if a tolerance is modified or
revoked. However, any potential problem in this area is solved by current EPA and
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FDA authority to delay action, or to utilize "action levels" to trigger discretionary
enforcement action.
Under S. 1074, however, EPA allows a revoked tolerance to remain in effect for
raw agricultural commodities and processed foods which, on the date of publication
of the regulation, contain pesticide residues in compliance with the original toler-
ance. This provision does nothing to protect the majority of existing legally treated
food-including growing but unharvested crops. In addition, it is not clear whether
the exemption would extend to processed food that is made the date of the regula-
tion from raw agricultural commodities which contained legal residues prior to the
date of the regulation.
This provision is wholly inadequate to protect this country's farmers who legally
apply products registered with EPA. On an even more basic level, the bill fails to
coordinate with similar pipeline provisions of F1FRA. F1FRA authorizes EPA, upon
cancellation of a productl and within EPA discretion, to allow pesticides to be used
until supplies are exhausted, on the assumption that limited use over the country is
environmentally preferable to concentration of the product in stopping its use, and
ordering its disposal. S. 1074 counteracts this sound environmental policy by effec-
tively prohibiting use of all unapplied pesticides in storage and inventory.
USER FEES
Current FFDCA provisions require those seeking to establish or lower a tolerance
to pay a fee, typically ranging from $10,000 to modify an existing tolerance, to
$50,000 to establish a new tolerance. S. 1074 will not only continue to assess these
same fees, but also authorizes(1) payment of an annual maintenance fee, and (2)
payment of a fee sufficient to cover the costs associated with reevaluation of all ex-
isting tolerances. This amounts to two new fees. If history is any indication, S. 1074
may well be the death knell for minor use products.
As a result of the additional fees levied on manufacturers through the F1FRA `88
re-registration process, hundreds of product registrations have been and will contin-
ue to be dropped because the manufacturers are unable to afford to keep them. In-
cluded in the lost registrations will be safer pesticides and minor use products. At
best, the additional fees required here will increase the cost of the product to the
manufactures, who will be forced to pass the increase on to the producer, who will
pass them on to the consumer. Higher food prices may not sound an alarm for the
well healed who regulate and advocate. However, for the vast majority of Ameri-
cans, higher food prices are not a realistic option when the result is food no safer
than it was before. Of course, the other possibility is to lose more minor use prod-
ucts.
CONCLUSION
Again, Mr. Chairman, I wish to thank you and the members of this Committee for
the opportunity to present these remarks on S. 1074.
The CHAIRMAN. I appreciate all of the statements and comments,
and we may submit some additional written questions to all of you.
I have been impressed with all of the panelists today indicating
their desire to work with the committee for a safer food supply. I
think there are varying and different opinions about the nature of
the process and procedures which are being followed and whether
existing laws are adequate in terms of continuing to provide safety
in some areas and permitting very careful oversight which I think
is necessary in a number of other areas, particularly with regard to
the children in our society.
We are going to take some action. There are dynamic forces out
of play across this country, and families will continue to be con-
cerned about the safety of the food supply. The question is are we
going to play a type of Russian roulette with certain areas of our
food supply, or are we going to proceed rationally. The States are
going to move ahead. Anyone who doesn't believe that hasn't been
traveling around the country. It is part of the whole political phe-
nomenon over the last 10 years. They've said if the Federal Gov-
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ernment won't do it-let the States do it. Well, the States are doing
it in a variety of different ways all over this country. They may
have defeated a proposal out in California, but there is an inevita-
bility about it.
So if we are not able to bring together in a responsible, reasona-
ble and rational way the various interest groups, I think there is
going to be confusion and disruption, and we will provide a real
disservice to the families in this country. And I think there is an
increasing awareness of this.
I mentioned at the outset of this hearing my appreciation for my
colleague Senator Hatch's willingness to work with us. We worked
with the administration and made important progress in the last
session. We weren't able to really achieve all the things I think all
of us would have liked to do, but we heard spokesmen and women
indicating different interests in this issue, and we will be listening
to you and will be calling on you as we move this process forward.
But the process will be moving forward, and I think the earlier, the
better, as far as I am concerned.
I want to thank all of you very much for your patience this
morning and for your comments. All the statements will be put in
the record in their entirety, and we'll permit a reasonable number
of questions by committee members if they so desire to be directed
toward any of the witness.
[Additional statements and material submitted for the record fol-
lows:]
PREPARED STATEMENT OF THE CHEMICAL PRODUCERS AND DISTRIBUTORS ASSOCIATION
I am, Gregory J. Duerksen, Chairman of the Food Safety Committee of the Chemi-
Cal Producers & Distributors Association. The CPDA is a voluntary, non-profit mem-
bership association consisting of some 75 companies engaged in the manufacture,
formulation, and distribution and sale of products used on food, feed, and fiber
crops, lawn, garden, and turf care, and public health pest control. I an, also Vice
President, Marketing and Development, for Terra International, Inc., one of the Na-
tion's largest crop production product and service marketers.
The CPDA sees several positive attributes in S. 1074, but we also have many seri-
ous concerns. We cannot support the bill as currently written, but believe that with
amendments the bill can be significantly improved. In fact, redefining the issues ad-
dressed in the bill could lead to legislation that would benefit consumers, environ-
mentalists, farmers, and pesticide manufacturers.
Let's look first at redefining the issue, then attributes of S. 1074, and finally con-
cerns regarding this bill.
REDEFINING THE ISSUE
As a father, I am acutely concerned about my kids' health and the safety of the
food they eat. As an environmentalist, I believe we need to continue cleaning up our
environment so people and wildlife will be able to enjoy it in ever-better condition
for generations to come. And as a part of the farm input industry, the CPDA's and
my company's responsibility is to help farmers produce a safe, abundant, affordable,
competitive food supply for the United States and world marketplace. Contrary to
popular opinion, these goals are not mutually exclusive; rather, they are comple-
mentary. But the policies and actions to achieve these goals must be thought
through and implemented carefully. Thus, while we applaud several of the ideals in
5. 1074, we are greatly disturbed by the sole focus of S. 1074 on pesticide residues.
As we consider pesticides and food safety, we must step back and ask ourselves
what the real issue is and what our real goal is. Is the issue pesticide residues? Is it
safety, and nothing else? Or is the real issue and goal the total health and nutrition
of United States and world consumers? We believe it is the latter.
S. 1074 addresses only the risks of using pesticides, but excludes consideration of
any benefits. This is shortsighted, as risks and benefits must be weighed. Moreover,
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comparative risks must be weighed. This simply says that all options have risks as
well as rewards, and these must be balanced. For example, when I took try kids to
the pediatrician for their whooping cough immunization shots, I knew that from the
vaccine there was a 1-in-10,000 risk they would contract whooping cough, which
can be fatal. However, this "sin of commission" was vastly less than the risk of dis-
ease and death. With the same logic, most cities chlorinate their water supply,
knowing that the cancer risk from chlorine-a known carcinogen-is less than the
public health risk of unchecked microbes in drinking water. We all use x-rays to
diagnose various illnesses, but an overdose of X-rays is bad for our health.
Likewise, using pesticides has risk, and not using pesticides has risk. One of
America's most prominent entomologists noted that "I would rather go into a super-
market and, say, find a tenth of a part per million of a certain pesticide on apples
or lettuce than to find a cockroach that is carrying 40 or 50 disease organisms on
his foot crawling over the lettuce. " There is a very good reason we use fungicides
on fruits and vegetables: fungus residues can be infinitely more harmful than pesti-
cide residues. And very importantly, the risk of not using pesticides is that food
costs would rise dramatically. In fact, a recent estimate by GRC Economics predicts
a 45, rise in food costs if synthetic pesticides and fertilizers were banned. This would
have a disastrous effect on the nutrition and health of the 30 million Americans
who already spend 60% of their income on food. And one of America's most signifi-
cant environmental and conservation advances of recent decades would be reversed
because soil erosion would rise dramatically as farmers substitute more cultivation
for pesticides.
Food must be affordable and abundant and safe to truly benefit the United States
and world consumer. One of the keys to economic growth, and the resultant im-
provements in quality and quantity of life, is that food costs as a proportion of
income have been continually dropping. In 1950, food and beverage costs were 19%
of America's GNP, and by 1990 they dropped to 11. On a $5.5 trillion GNP, this sav-
ings is worth over $400 billion annually. That's nearly $600 per year per person, and
enough to pay for 20 Clean Air bills. These savings are at least partially attributa-
ble to productivity improvements from pesticides.
Why is this important? The National Research Council says that nutrition is the
number one food-related public health issue in the United States. Quite simply, af-
fordable food makes better nutrition possible for the people who most need better
nutrition. Conversely, well-intentioned but incomplete pesticide. residue legislation
that leads to higher food costs forces a most cruel and pernicious choice on those
who can afford it the least. Specifically, "Can my family afford fresh fruits and
vegetables? Can my family afford meat?" I speak from experience. Growing up in
rural South Dakota, in winter my parents often had to ask whether they could
afford fresh fruits and vegetables for their kids. Often the answer was "no." No
family should have to make that cruel choice. Properly crafted, S. 1074 could help
ensure that choice must never be made.
Consumers in the United States are only part of the issue. One quarter of our
agricultural production is exported, and much of that to developing countries. If leg-
islation leads to higher commodity prices, the poorest will suffer. Our agricultural
competitiveness will also be undermined, and consequently our balance of trade will
suffer. In 1950, agricultural exports were only $3 billion, but in 1969 they were $40
billion. Loss of these exports would adversely affect our entire economy.
We could spend billions of dollars on higher food prices, wreak havoc on the econ-
omy and labor force, and at best have no safer food supply. That is because, thanks
to our current system, pesticide residues are irrelevant in their contribution of car-
cinogens to the daily diet. Several prominent scientists have estimated that we con-
sume roughly 1,500,000 micrograms daily of naturally-occurring carcinogens, while
the Food & Drug Administration estimates that the average American consumes
150 micrograms of pesticide residues daily, of which 45 micrograms are possibly car-
cinogenic. In comparison, University of California at Berkeley researchers estimate
that one large potato contains 15,000 micrograms of natural carcinogens (various
alkaloids), one cola contains 2,000 micrograms of the natural carcinogen formalde-
hyde, and even a slice of bread has 185 micrograms of the same substance.
This does not mean we should quit eating potatoes or bread, but simply points out
the old toxicologists' maxim that "the dose makes the poison." For example, salt is
essential to life, but the amount you can hold in your hands can kill you. Vitamin A
is essential, but at high enough doses it is a reproductive toxin. Now I do not mean
to imply that pesticides are essential to life, but am simply trying to point out that
infinitesimal amounts are irrelevant.
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ATTRIBUTES OF 5. 1674
The single most important attribute of this bill is that it does indeed recognize
that infinitesimal amounts of pesticide residues are irrelevant, and would replace
the Delaney Clause with the concept of negligible risk for non-threshold pesticides.
This is a very important acknowledgement of our ever-increasing ability to detect
miniscule quantities of substances.
And regarding what level of negligible risk is acceptable, in concept we have no
objection to a target of a one-in-a-million standard, but in practice our regulators
must not be tied to a specific number, because they must be allowed to look at com-
parative risks (The whooping cough vaccine situation cited earlier is a perfect exam-
ple.) and adjust to rapid scientific advances in risk assessment.
Government agencies should not be placed in a numerical straitjacket, but should
be given the flexibility to modify their views of acceptable risks based on scientific
advances. This flexibility is essential because of changing technology, our changing
ability to assess and understand comparative risks and benefits, and the need to un-
derstand what is the appropriate safety factor in each situation. Many argue that,
in the case of pesticides, there must be no more than a one-in-a-million risk. Just
where does this number come from? We suspect it simply sounds "safe." And it may
in fact be the right level of safety. But sometimes not.
This concept of negligible risk was summarized eloquently in 1989 testimony
before the House Agriculture DORFA subcommittee by Dr. Charles Benbrook, then
Executive Director of the National Academy of Science's Board of Agriculture. He
concluded that there were "valid arguments both for and against specifying a quan-
titative benchmark in the definition of negligible risk." Benbrook concluded, that
"... In the end, the committee was persuaded that quantitative risk assessment
methods, and the science underlying estimates of carcinogenic risks, were too fragile
and changeable to either assert that risks below a certain level are truly `negligi-
ble', or that risks above the `negligible' level indeed pose a significant risk of cancer
in man." It is important that these scientific evaluations be made only on a case-by-
case basis after a complete review of the toxicological data base. We believe it is
prudent not to set definitive numerical values for negligible risk within any statuto-
ry provision.
In addition, any negligible risk standard requires fact-based risk assessment. Un-
fortunately, S. 1074 dictates an onerous worst-case scenario that barely qualifies as
theoretically possible: pesticides must be assumed to be used on 100 percent of the
crops and acres labelled, residues are at the maximum allowed, and consumption of
residues occurs at the maximum for 70 years. The chance of any of these worst-case
assumptions occurring is extremely remote, so total residue exposures are vastly
overstated.
We propose a two-point approach to get a realistic handle on pesticide residue ex-
posure: pesticide record-keeping, and a market basket approach to residue monitor-
ing. As a result of the 1990 farm bill, farmers will already be required to keep
records of restricted-use pesticide applications. This process could be expanded to all
pesticides. And the FDA already does limited testing of foods to look for pesticide
residues, which could be broadened to provide a statistically-significant overview of
pesticide residue exposure in the foods we actually eat. The result of this two-point
approach is that we would find some pesticides where the risk is greater than we
had assumed, and others where it would be less, and we could respond accordingly.
With this more realistic risk assessment, we then pave the way for introduction of
safer, more cost-effective pesticides that serve the total health improvement goal de-
scribed earlier.
A "no observable effect level" (NOEL) is proposed for determining negligible risk
for threshold pesticides. Again, we applaud the concept of dividing the NOEL by 100
to establish an Acceptable Daily Intake (ADI), but don't believe we should lock the
EPA into a rigid number, as we need flexibility to respond to our changing knowl-
edge base.
Another attribute of 5. 1074 is that it points out the need to evaluate the expo-
sure of pesticide residues to population subgroups. However, the EPA needs the
flexibility to change the population subgroups evaluated as new information
emerges or specific situations arise, and should not be locked in to a rigid list of
subgroups.
While we are establishing the negligible risk and risk assessment provisions, we
must also establish national uniform tolerances and procedures. The States are
simply not prepared to adequately set up fact-based standards and then review
them. Consequently, leaving them to set their own standards would make 5. 1074's
noble efforts irrelevant in the wake of decisions based on emotion, conjecture, and
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misrepresentation. We believe the EPA should set tough standards, taking into ac-
count specific local situations, but then allow these standards to be uniform, thus
balancing the need to protect our environment and allow cost-effective product de-
velopment and testing. In addition, national uniform tolerances ensure that inter-
state and international barriers to trade are kept to a minimum.
We also approve of most of the provisions and process steps outlined for petitions
and actions by the EPA Administrator. However, we are very concerned about the
judicial review sections. First, there is no objection or hearing step before a denial of
a tolerance becomes final, and the only option is judicial review. And the judicial
review option is opened to any person who may be adversely affected, and specifical-
ly including those who do not have an econOmic interest. This, plus provisions which
allow the recovery of attorney and expert witness fees, is a loud invitation to frivo-
lous lawsuits. The problem is compounded by the placing of the burden of proof on
the EPA rather than the petitioner, even to the point of requiring the court to de-
termine that the defined data are adequate to keep the tolerance. This is quite
simply a "guilty until proven innocent" approach.
CONCERNS WITH 5. 1074
This bill has a number of concerns that we believe can be addressed and correct-
ed.
Under the definitions, for example, negligible risk is defined as "reasonably cer-
tain to cause no harm to human health," and residue tolerances must be established
at a level which "will not cause or contribute to any known or anticipated harm to
human health." These could easily be interpreted as zero-risk standards.
Pesticides are redefined to include inerts, which means manufacturers would be
required to get a tolerance or exemption for each inert, even though many are on
the GRAS list. This is simply a waste of researcher and EPA resources that could be
better spent trying to develop and approve newer, safer pesticides or reregister older
pesticides. We suggest establishing tolerances only for those inerts of toxicological
concern. In fact, the EPA is already reviewing this category through data call-in ac-
tivities.
A proverbial Pandora's box of new taxation is opened in the provisions that au-
thorize new fees to do this work. First, we don't think new fees are needed, because
if any of the activities envisioned in this bill are priorities, the EPA can do them
and let lower priorities wait. Moreover, if new fees are indeed necessary, they must
have a narrowly-defined purpose and the EPA must have tight performance stand-
ards to ensure the money is not wasted.
Lastly, the proposed evaluation of existing tolerances and the accompanying time-
table is an impossible task. Tens of thousands of tolerances will have to be reproven.
The Administrator needs much more flexibility in this entire area to set priorities.
More fundamentally, this task is already being accomplished through the reregistra-
tion process.
We have many other procedures and process concerns, but the above issues are
the most important.
CONCLUSION
In summary, 5. 1074 needs an integrated, balanced approach to pesticide use, food
safety, and the broader and more important issue of the total health and nutrition
of American and world consumers. We need an approach that understands the al-
ternatives of "sins of omission" and "sins of comission". We need to look at real
data (i.e., market basket approach) and real risks, not ivory-tower chemophobe
models. We welcome the opportunity to work with you on 5. 1074 so it truly ad-
vances the long-term health and environment of the United States and the world.
JOINT PREPARED STATEMENT OF THE NATIONAL CORN GROWERS ASSOCIATION, THE
AMERICAN SOYBEAN ASSOCIATION, THE NATIONAL ASSOCIATION OF WHEAT GROWERS,
THE NATIONAL BARLEY GROWERS ASSOCIATION AND THE NATIONAL COTTON COUNCIL
Chairman Kennedy, I am very pleased to address your committee on behalf of the
National Corn Growers Association, the American Soybean Association, the Nation-
al Association of Wheat Growers, the National Barley Growers Association and the
National Cotton Council. Our groups have forged a close working relationship on
many environmental and conservation issues that has been beneficial for our mem-
bers and, we hope, for congressional debates on these topics.
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The issue that initially brought us together involved the wholesomeness of our
Nation's food supply and it is thus with a sense of satisfaction that I address food
safety here. Our farmers turn out the most abundant array of high-quality food and
fiber available on earth. That abundance also allows American consumers to pay a
smaller percentage of their income for food than people in any other country in the
world. Obviously, our Nation's generous resources of land, water and climate de-
serve much credit for the bounty we harvest each year. I'd even like to think farm-
ers' knowledge of the land has a little to do with it. But it is undeniable the use of
pesticides and other chemical inputs plays a major role in helping farmers produce
the food supply Americans take for granted.
We know it is not just the quantity of food we produce that is important. We also
know we must maintain the high quality of our agricultural products. For the most
part, the Federal regulatory system has worked well to ensure our food supply is
safe, and where it has not worked well enough the problem has frequently been a
lack of agency resources. Our organizations realize that skepticism about our ability
to deliver safe food is cause for concern and we reiterate our commitment to work
with you and other government officials to maintain public confidence in our food
supply.
Mr. Chairman, you and your House colleague, Rep. Henry Waxman, have been at
the fore of the food safety debate in Congress, and by introducing S. 1074 you are
again proposing major revisions to our nation's regulation of pesticide use. While
your bill would improve current law in several respects, it also has numerous provi-
sions that would make current law unworkable, seriously harm agriculture and
compromise our food supply.
We submit that the Food Safety Assurance Act, introduced by several members of
the House Agriculture Committee in the last Congress, would bolster consumer con-
fidence through a much more balanced approach toward improving Federal regula-
tion of pesticide use.
At this juncture, I'd like to outline our positions on a wide range of pesticide regu-
lation issues, including observations on some of your proposals. With respect to the
cancellation provisions of the Federal Insecticide, Fungicide and Rodenticide Act,
the Environmental Protection Agency is now empowered to cancel a pesticide regis-
tration if information shows the chemical presents an unreasonable risk to human
health or the environment. But the cancellation process can be unnecessarily time-
consuming and expensive and rarely reduces controversies about either a pesticide's
continued use or EPA's ability to regulate pesticides responsibly. Legislation is
needed to streamline the process while retaining provisions for public participation
that would contribute to valid scientific assessments of pesticide products.
If such improvements to the FIFRA cancellation process are made, changes in the
current suspension authority would be inappropriate. EPA has substantial authority
to temporarily suspend a registration pending permanent cancellation proceedings
if the pesticide poses an "imminent hazard." Changes in either that.hazard thresh-
old or suspension procedures would curtail the public's ability to participate in regu-
latory decisions and could result in the removal of essential pesticides from the mar-
ketplace.
While we feel current suspension authority is adequate, we agree with you that
changes are needed in the outmoded "zero risk" Delaney Clause of the Federal
Food, Drug and Cosmetic Act, which regulates pesticide residues on food. We oppose
your proposal of a rigid numerical risk standard, however. A narrative definition of
"negligible" risk more realistically assesses risks at a time when testing procedures
now can measure truly minuscule residues-down to the part-per-trillion or part-
per- quadrillion. We also find fault with your bill's rigid formulae for risk calcula-
tion, its imposition of arbitrary quantitative standards, use of theoretical assump-
tions on exposure that are known to be false, and preclusion of the use of biological
data on mechanism of action. Instead, we feel all scientific information and known
factual data should be used in determining negligible risk.
Benefits of pesticides should also continue to play a role in regulation of pesticide
use and allowable residues, and your bill's failure to do so is a major cause of con-
cern for our groups. It is only logical to give weight to a pesticide's contribution to
improved public health and welfare through availability of foods that are nutritious,
varied, economical and safe, as well as its role in maintaining a robust agricultural
economy.
The vitality of the farm sector is threatened by a patchwork of different State-set
tolerances. for acceptable pesticide residues that could interrupt food production
and distribution. Unfortunately, your proposal fails to address the need for uniform
tolerances for pesticides that meet the comprehensive data requirements of current
EPA regulations. Any new legislation should provide that, with limited exceptions,
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tolerances established by EPA for pesticides that have been reregistered under up-
dated FIFRA standards be applicable nationwide.
Speaking of the reregistration process, amendments are needed to ensure pesti-
cide registrations and supporting data are current. Pesticide registrants should peri-
odically submit scientific data and other information sufficient for EPA to deter-
mine whether existing registrations are proper. This reregistration provision should
establish benchmarks for data submission and EPA review.
Consultation and coordination within the Federal Government on food and pesti-
cide regulations also needs improvement. Given the linkage between pesticide use,
agricultural production and food safety, regular consultation is needed between
EPA, the Department of Agriculture and the Food and Drug Administration. Our
groups have been encouraged in recent weeks, however, to hear officials from EPA
and USDA praise each other for cooperating in a variety of areas. We hope that
spirit of coordination will flourish in the months ahead.
Finally, looking beyond our borders, current U.S. regulation of pesticide exports
should be amended to guarantee both pesticide use abroad and pesticide residues on
imported food do not endanger human health. The amount of FDA sampling of food
imports needs to be increased and residue monitoring improved. In addition, exports
of pesticides that have been cancelled for human health reasons should be prohibit-
ed.
Mr. Chairman, as was the case when it began 2 years ago, the issues of the food
safety debate continue to be complex and, frequently, emotional. But just as our or-
ganizations have worked together to hammer out common, realistic positions, we
hope you and other Members of Congress can reach consensus on proposals that will
balance legitimate science-based concerns about pesticide use with the enormous
benefits they allow farmers to give our society. Thank you for allowing me to pass
along the views of our Nation's barley, corn, cotton, soybean and wheat farmers.
PREPARED STATEMENT OF LARRY THOMSEN PRESIDENT, NATIONAL AGRICHEMICAL
RETAILERS ASSOCIATION
Mr. Chairman and members of the subcommittee, on behalf of the over 1,500
retail dealer members of the National AgriChemical Retailers Association (NARA)
who market pesticides directly to farmers nationwide, I would like to thank you for
giving our segment of the pesticide industry an opportunity to submit a written
statement regarding 5. 1074, the "Safety of Pesticides in Food Act of 1991."
The members of NARA do not support S. 1074 because the bill would be detrimen-
tal to the production agriculture industry in the United States and the general
economy of our agriculturally dependent rural communities. Many of the small ag-
ribusinesses that are owned and operated by the members I work for, including our
cooperative, would be economically impacted by this bill. By forcing safe pesticides
off of the market due to its overly stringent standards and increasing the cost of
getting much needed crop protection chemicals to market, the bill will negatively
affect agricultural production. Since many of the technical aspects of this bill have
been covered by industry experts on Food Safety, I would like to focus on the poten-
tial "real world" effects 5. 1074 will have on agriculture, and then discuss our spe-
cific objections to the bill.
POTENTIAL REAL WORLD EFFECTS ON AGRICULTURE
Nature makes it difficult for farmers to produce crops in the face of hundreds of
weed species, 1,500 plant diseases, more than 1 million insect species, and at least
1,000 species of nematodes. However, with the development of crop protection
chemicals, one U.S. farmer now feeds over 120 people around the globe and has in-
creased food and fiber productivity more than 230 percent since 1940.
With the restrictions that would be imposed by 5. 1074, products that are now
considered safe and have contributed to our abundant food supply would be taken
off of the market due to overly restrictive risk standards and other stringent re-
quirements. In addition, 5. 1074 may force many domestic crop protection chemical
manufacturers with a global market to move their production facilities overseas. In
turn, American farmers who depend on products developed and produced in the
United States would be forced to depend on products produced overseas. Although
some would dispute this statement as industry rhetoric, I can give you an example
of a situation that currently exists in the crop protection chemical business to sup-
port my claim. This example makes a comparison between the current situation
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with regard to minor-use pesticides and the potential effect S. 1074 could have on
our farm community.
Today, as a result of the reregistration requirements contained in the amend-
ments to the Federal Insecticide, Fungicide and Rodenticide Act in 1988, many
minor use products used in the fruit and vegetable industry will be lost, wreaking
havoc on the consumer market. S. 1074 will only enhance these problems by requir-
ing further testing requirements and overly conservative risk standards, placing
more of the over 2,000 minor use pesticides currently in jeopardy of losing their reg-
istration out of the market. Testing requirements to support registration include
toxicological studies that cost several million dollars. When comparing this multi-
million dollar cost with the $10,000 gross revenue that a minor use product brings
in, it is easy to predict that the registration for that product, no matter how impor-
tant to the U.S. farm community, will be dropped. The ripple down effect of lost
minor-use products will result in lost major use products, causing a greater reliance
on foreign produced food.
By carefully assessing the requirements that S. 1074 proposes and reviewing our
current experiences with minor use products, it is safe to assume that many prod-
ucts will be dropped from the market at great cost to the American consumer and
agricultural industry. The "real world" effects must be considered before the bill is
passed.
SPECIFIC OBJECTIONS TO THE BILL
NARA is opposed to the passage of 5. 1074 for the following specific reasons.
1. Eliminates the consideration of the benefits of pesticides to the public;
2. Establishes overly rigid numerical risk standards;
3. Does not address current problems between Federal, State, and local law; and
4. Proposes overly conservative exposure assumptions.
ELIMINATION OF BENEFITS CONSIDERATION
S. 1074 proposes to eliminate the consideration of benefits when regulators set tol-
erances for a particular pesticide on all food. NARA strongly opposes this particular
aspect of the bill.
Failure to consider the benefits of a pesticide, which may have minimal impact on
human health but enormous benefits in food production, is not sound public policy.
Studies have shown that the economic and social cost of banning the use of certain
pesticides is high. According to a study conducted by the United States Department
of Agriculture's Economic Research Service, banning Alachior and Methachior in
corn and soybean production would cost $2.2 billion per year, and banning Triazines
would result in losses of $3.4 billion per year. In our view, the elimination of benefit
analysis may increase the likelihood that certain safe and beneficial pesticides, like
those mentioned above, could be taken off the market, in light of the more stringent
negligible risk standard that 5. 1074 proposes.
Congress must not only consider the benefits that pesticides provide in food pro-
duction, they must also weigh the economic welfare of rural, agriculturally depend-
ent communities. Just like a drought, flood or other natural disaster, pests can
cause total economic ruin for agricultural producers in a very short period of time.
Without the insurance that pesticides provide, farmers go unprotected, leaving in
their wake the small businesses and communities they support.
ESTABLISHMENT OF RIGID NUMERICAL NEGLIGIBLE RISK STANDARD
Although our members support the establishment of one negligible risk standard
in regulating pesticide residues in all food, 5. 1074 extends beyond what is necessary
and prudent by proposing a rigid one-in-a-million standard for non-threshold risk
and a 100 fold standard for threshold risk. Our members are confused as to why the
authors of this legislation continue to propose the establishment of a concrete risk
standard when the overwhelming consensus among the scientific community rejects
this proposal.
Why is the establishment of a set risk standard opposed by scientists? First, the
science of risk assessment is continually changing, with new and more accurate as-
sessment procedures being developed. A set risk number would become obsolete and
unworkable as science changes. Second, each chemical is unique, presenting a differ-
ent set of variables which must be considered when evaluating risk. A set risk
number unfairly establishes criteria that may or may not be met by a particular
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pesticide, jeopardizing its registration based on inaccurate analysis and inflexible
criterion. From a small agribusiness perspective, the establishment of a concrete
risk number could result in unfair removal of many products from the market.
In addition, the bill calls for a special risk standard for the first 5 years after a
person is exposed. This special standard was established to address concerns over
the potential exposure of children to pesticide residues. We feel that this proposal is
premature in light of the forthcoming National Academy of Sciences (NAS) report
on pesticides in the diets of children. Congress should wait for the results of this
study before it establishes overly conservative risk numbers for children.
UNIFORM TOLERANCE PROVISION
Only exacerbated by the recent U.S. Supreme Court decision which gives local ju-
risdictions the power to write their own pesticide laws, this bill fails to address the
interface between existing Federal and State regulation of food. Currently, States
are setting lower tolerances for pesticide residues in food than those established by
the U.S. Environmental Protection Agency (EPA). This situation, where distribution
and marketing systems must cope with a patchwork of inconsistent State-by-State
requirements, creates the potential for considerable consumer confusion and sub-
stantial disruption of interstate commerce in food production.
In light of the recent Supreme Court decision, Congress must act soon, allowing
already stringent Federal standards to preempt State and local standards. Vari-
ations by States and local jurisdictions only hinder trade, thereby diminishing the
United States' competitiveness on the world agricultural market.
CONSERVATIVE EXPOSURE ASSUMPTIONS
5. 1074 proposes that the EPA make pesticide exposure assumptions which clearly
are unreasonable and would hurt the agricultural industry. For example, 5. 1074,
among its many other overly conservative requirements, requires the EPA to
assume that residues occur in 100 percent of commodities for which treatment is
legal, and that all crops have the maximum permitted residue. From personal expe-
rience, I can tell you that the assumption that the same residue occurs in 100 per-
cent of commodities for which treatment is legal, never happens.
The farm cooperative that I work for in Iowa markets many different pesticides
used on corn for the same agronomic purpose. Taking this fact into consideration,
forcing the EPA to assume that certain residues from particular products are found
on all corn would greatly overestimate the actual residue that exist. Simply stated,
the very conservative exposure assumptions contained in 5. 1074 would detrimental-
ly affect U.S. agriculture. Neither the public nor the food producing industry is
served by assuming worst case scenarios when actual use data is available to pro-
vide more realistic and accurate information. Reality must be an integral part of
establishing food safety standards.
CONCLUSION
5. 1074 goes far beyond what will be workable for the agricultural community and
promises to exacerbate our current problems with minor use pesticides and reregis-
tration efforts. Because the United States produces the safest food in the world, I
think that the goal of Congress, through S. 1074, to predict our citizens' health by
unreasonably governing pesticide use may only diminish our profitable agricultural
industry without increasing our country's health standards.
NATIONAL AGRICHEMICAL RETAILERS ASSOCIATION
Washington, D.C. 20005, July 11, 19111
The Honorable EDWARD KENNEDY,
U.S. Senate,
Washington, DC 20510
DEAR SENATOR KENNEDY: Enclosed is a copy of the written statement of Larry
Thomsen, president of the National AgriChemical Retailers Association (NARA), op-
posing 5. 1074, the "Safety of Pesticides in Food Act of 1991." NARA represents
over 1,400 retail AgriChemical dealers across the United States.
Due to the delayed announcement of the hearing by the Senate Labor and Human
Resources Committee, Mr. Thomsen was unable to present an oral statement. How-
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ever, his written statement was made part of the Record. Below, I would like to
review NARA's problems with the bill.
First, the bill contains a rigid formula for risk calculation, imposes arbitrary
quantitative standards, requires the use of theoretical assumptions on exposure that
are known to be false, and prevents the use of biological data on mechanism of
action. These problems will result in perfectly safe products being taken off the
market.
Second, the bill fails to address the need for uniform tolerances for pesticides that
meet the comprehensive data requirements of current EPA regulations. In light of
the recent Supreme Court Decision granting local jurisdictions the power to make
their own pesticides laws, Congress needs to take action immediately to prevent a
national agricultural catastrophe resulting from thousands of unworkable laws.
Third, the bill fails to provide for consideration of health, nutrition, agriculture,
and other consumer benefits in determining whether a tolerance should be permit-
ted for a pesticide in food products. This proposition is completely unrealistic. Pesti-
cides unquestionably provide tremendous benefits to society.
Fourth, the bill would increase the loss of minor use pesticides and would further
discourage the development of pesticides for minor use. In fact, the over 2,000 minor
use registrations currently in jeopardy would, in most cases, be taken off the market
immediately.
Thank you for taking into consideration our views on 5. 1074. I look forward to
hearing from you regarding your position on the bill.
Sincerely,
CHRIS MYRICK, DIRECTOR
Legislative/Regulatory Affairs
PREPARED STATEMENT OF THE NATIONAL COUNCIL OF FARMER COOPERATIVES
Mr. Chairman and members of the committee, the National Council of Farmer
Cooperatives (National Council) is pleased to submit comments regarding S. 1074,
the "Pesticides in Food Safety Act of 1991," as well as pesticide-related food safety
issues generally as an integral component of successful national food policy.
In our comments, we hope to accomplish three interrelated objectives:
1. Advocate improvements in food safety within the context of overall, national
food policy objectives;
2. Describe the unique partnership between farmers and the cooperatives that
they own, and pro-active programs which provide valuable technical assistance that
help farmer-members utilize crop protectants more safely and effectively;
3. Offer our views on the proposed legislation.
INTEREST OF THE NATIONAL COUNCIL
The National Council of Farmer Cooperatives is a nationwide association of coop-
erative businesses which are owned and controlled by farmers. Its membership in-
cludes over 100 agricultural marketing, supply and credit cooperatives, plus 32 State
councils. National Council members handle practically every type of agricultural
commodity produced in the United States market these commodities domestically
and around the world, and furnish production supplies and credit to their farmer
members and patrons. The National Council represents about 90 percent of the
nearly 5,000 local farmer cooperatives in the nation, with a combined membership
of nearly 2 million farmers.
The farmer cooperative community includes food processors and distributors, as
well as farm input suppliers. Cooperatives account for 80 percent of the milk and a
large portion of the cotton, grain and soybeans produced in the United States. A
large share of the fruits, nuts and vegetables on supermarket shelves, and ultimate-
ly on dinner tables, arrived there through the efforts of cooperatives. Cooperatives
also are in the important business of supplying farmers with fuel, fertilizers, crop
protectants, feed, seed and other important elements of production.
Cooperatives are unique in the agribusiness community, in that farmer-members
comprise the ownership. Farmers and their families are also consumers who have a
direct stake in ensuring that the food products theV consume are safe. Additionally,
as stewards of the land, farmers are "front line' environmentalists, striving for
sound ways to produce food while protecting the natural resource base for them-
selves and future generations.
The National Council believes that the U.S. food supply is among the safest in the
world, and supports responsible efforts to make the food supply even safer. The
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issue of food safety impacts virtually every segment of the National Council mem-
bership-the producer-members who rely on and utilize agricultural chemicals, as
well as the cooperatives responsible for supplying them-and processing and mar-
keting cooperatives which are concerned about their ability to deliver a safe, high
quality product to the retail shelf and ultimately the consumer.
FOOD POLICY OBJECTIVES CRITICAL INGREDIENTS OF DEBATE
OVERAGRICULTURE'S USE OF CROP PROTECTANTS
If the National Council could add one dimension to the discussion concerning food
safety, it would be to urge that full consideration be accorded to possible impacts on
food policy before decisions are made. As indicated in Attachment 1, entitled "Food
Policy in Perspective," the National Council believes that the continued well -being
and security of the United States is dependent on our ability to continue providing
consumers with a safe, dependable, adequate supply of food at reasonable prices.
This is the fundamental national food policy that we have in place today.
We would submit that the key to success in any legislation on food safety is the
achievement of a difficult but critical balance between moving forward with needed
improvements in the food safety arena, while at the same time remaining sensitive
to the need for maintaining access to crop protectants and other critical inputs that
are so necessary for the continued success of American agriculture in sustaining
vital food and agricultural policy objectives.
FOOD SAFETY LEGISLATIVE OBJECTIVES
With this larger perspective in mind, the National Council recommends that legis-
lation on food safety be enacted which responds to the following interdependent ob-
jectives:
1. Establish the Federal Government with primary responsibility for ensuring the
safety of our food supply by providing for nationally uniform tolerances, including
any related labeling considerations;
2. Provide for establishing regulations on the basis of sound, scientific evidence,
together with improvements in monitoring and testing, with equal enforcement for
domestically produced and imported food;
3. Ensure that food safety-related decisions reflect the need for agriculture to
maintain access to the diverse range of critical crop protection chemicals and other
alternatives that are necessary to combat aggressive and highly adaptable crop
pests on a sustainable basis;
4. Provide for increased research and extension efforts aimed at maintaining agri-
culture and the food industry's ability to provide consumers with a dependable, safe
and wholesome supply of food at reasonable prices in an environmentally sound
way; and
5. Provide the necessary resources to allow the Federal Government to better
communicate what is being done to protect consumers and the public at large with
regard to the safety and wholesomeness of our food supply.
We believe coordinated action on these fronts offers real potential to (1) achieve
needed improvements in food safety policy, and (2) maintain consumer confidence,
both in the safety of our food supply and in the ability of the Federal Government
to protect consumers' interests.
TECHNICAL ASSISTANCE AND QUALITY CONTROL ACTION PROGRAMS
Cooperatives in their special partnership with farmer-members treat the critical
food safety and environmental responsibilities which accompany our food mission
most seriously. Cooperatives have responded to food safety and environmental chal-
lenges in a number of ways.
By way of example, the National Council would like to share briefly with the
Committee some highlights about the operations of Cenex/Land O'Lakes Ag Ser-
ices. We do so for two reasons:
1. First, we would respectfully submit that success in achieving food safety goals
starts in the field, through the day-to-day dedication and commitment of those who
must produce that food-American farm families.
2. Second, a number of significant provisions in the proposed legislation being con-
sidered by the Committee are based at least in part on critical assumptions about
how pesticides are used in farm production. Consideration of how contemporary ag-
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riculture operates may be helpful to the committee in deliberating the appropriate-
ness of those assumptions.
Cenex/Land O'Lakes Ag Services is a farm supply and technical services joint
venture involving Cenex and Land O'Lakes, both of which are farmer-owned coop-
eratives. Their 300,000 farmer-members in the upper Midwest and Pacific North-
west are served through a network of 1,250 locally owned and control led coopera-
tives.
Cenex provides petroleum products to farmer-members. Land O'Lakes takes high
quality milk produced by dairy farmers in the Midwest and helps them achieve
higher returns for their milk by manufacturing and marketing dairy products
under the national brand name. However, many people aren't aware that these co-
operatives also work with farmers who raise corn, soybeans, wheat and other crops,
providing them with plant foods crop protection products and technical services.
That's the portion of their business that we'd like to describe for you today.
The Cenex/Land O'Lakes Ag Services environmental mission statement that
drives the cooperative in its everyday operations, reads as follows: "To actively and
responsibly support stewardship of our natural resources, while maintaining a posi-
tive balance between the environment, the economic well being of agriculture and
global food needs."
Scientific information management is a major part of this cooperative sanction
program to assist farmers in carrying out this important mission. Some of the na-
tion's leading experts are employed to help the cooperative system develop a pro-
active approach to environmentally sound crop production practices.
Computer programs have been designed and provided to local cooperatives that
can combine extensive data on crop protection products and nutrients with individ-
ual field histories, yield goals and other pertinent data. Farmers can plug into this
sophisticated system and tailor the soundest application rates on a field by field
basis. In addition, local cooperatives have access to important information and as-
sistance through Cenex/Land O'Lakes, which closely tracks changes in pesticide and
other environmental, regulatory compliance requirements.
Furthermore, Cenex/Land O'Lakes has made a major commitment to provide in-
creased "hands on" assistance to farmer-members. For example, more than 300
trained field technicians working through local co-ops are available to work directly
with individual farmers from planting through harvest in conducting soil tests, eval-
uating pest problems and advising on Best Management Practices.
Best Management Practices, or BMP's, is a term now commonly used in referring
to a range of proven, scientific crop management practices which help farmers con-
trol production costs and protect the environment. Integrated Pest Management, or
1PM, is one type of BMP which involves a philosophy of reducing chemical pest con-
trols while sustaining food production. 1PM techniques include increased crop moni-
toring, pesticide applications targeted at specific pest infestations, and the develop-
ment of new genetic and biological pest controls. For example, one approach in-
volves the introduction of "good bugs" to eat "bad bugs."
Other cooperatives are making similar commitments in partnership with their
farmer-members. Different approaches best fit the special circumstances of various
farming systems and regions. Cooperatives' continuing goal is to work alongside the
research community in looking for improved ways of producing a safe, dependable,
adequate, food supply at reasonable prices, in an environmentally sound manner.
The cooperative community is justifiably proud of its role in going well beyond
the "letter of the law" by attempting to respond to its true spirit through aggressive
programs contributing to the responsible and efficient use of crop protectants, and
the resulting demonstrated safety record of this Nation's food supply.
The National Council believes this is a positive story worth sharing with others
involved in the food safety debate, as it may prove helpful as we all strive to craft
workable solutions. Members of the committee are welcome to experience this story
firsthand. We would be pleased to arrange for you to visit with the real people who
make it happen-farm families and cooperative managers-as well as observe the
programs we have described in operation.
VIEWS ON 5. 1074
It is within the context of cooperatives' hands-on involvement in the science of
food production and a firm conviction that needed food safety improvements must
occur as a coherent component of food policy that the National Council offers com-
ments on the proposed legislation (5. 1074). National food policy objectives have
been and continue to be to provide consumers with a safe, wholesome, dependable
and abundant supply of food at reasonable prices. The overriding question we at-
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tempted to address in reviewing S. 1074 is whether the proposal would make needed
food safety advances and allow American agriculture to continue fulfilling these im-
portant objectives.
We cannot predict exactly what would occur under this proposal if it were to
become law, and it is ultimately up to the scientific community to puzzle over the
critically important question of which pesticides or classes of pesticides might be
lost But it is possible for us to evaluate the appropriateness of the various provi-
sions, as to their likely practical effects.
5. 1074 advances a number of conceptual approaches that offer considerable po-
tential to improve existing law. Most notably, the National Council applauds the
effort to apply a single, negligible risk standard for both raw and processed foods.
Elimination of the so-called "Delaney paradox," created by conflicting provisions in
Sections 408 and 409 of the Federal Food, Drug and Cosmetic Act (FFDCA), is long
overdue.
We must point out, however, several provisions which we believe would function
in a manner that would jeopardize interrelated food policy and safety objectives:
First, the proposed use of arbitrary quantitative standards in rigid formulas im-
plies a level of accuracy and degree of sophistication which simply do not exist in
the scientific arena of evaluating risks associated with long-term exposure to ex-
tremely low levels of pesticide residues.
This is compounded by the required use of assumptions about pesticide applica-
tion practices and exposure that clearly do not reflect what is known. A "cookbook"
approach in automatically applying pesticides to 100 percent of the crop, at the
maximum rate on the label, is clearly not the practice in most of agriculture.
For example, in most instances applications are avoided entirely when possible,
and when necessary are targeted in response to infestations above economic thresh-
old levels. In addition, residue levels on foods tested prove overwhelmingly to be
either zero or well below the maximum allowable. We are confident that surveys
currently being conducted by the U.S. Department of Agriculture and the Environ-
mental Protection Agency (EPA) will reaffirm these assertions.
While the methodologies for risk assessment are the best currently available, they
are based heavily on theories and presumptions that are distinctly lacking in verifi-
able precision. There are no actuarial data of which we are aware to support asser-
tions that theoretical risks are representative of actual risks faced by consumers.
The policy decision process using such methodologies should reflect their limita-
tions.
Second, our concern about these deficiencies is magnified by the fact that the bill
utilizes the risk calculations in establishing a sharply defined risk threshold in a
manner that would override other legitimate considerations, including the many
benefits that legitimate use of pesticides offers. Health, nutrition, agricultural and
other consumer benefits should be part of the equation in determining whether a
tolerance should be permitted for a pesticide residue in food products. While such
benefits may not be readily quantifiable, they are both legitimate and critical.
Third, it would seem desirable policy to reconcile differences in the major statutes
governing pesticides. The proposed bill takes an important step in this direction by
attempting to remedy inconsistencies within the FFDCA. However, it would make
the FFDCA even less compatible with the other major statute governing pesticides,
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Specifically, 5. 1074
proposes a reevaluation of all food-use pesticides on an accelerated time schedule
which we believe is unworkable. It virtually ignores a comprehensive pesticide re-
registration schedule already in operation as a result of the 1988 FIFRA amend-
ments. That schedule is already taxing the resources of the EPA and industry.
Fourth, 5. 1074 is silent on the issue of national uniformity in setting tolerances
for pesticides, as well as related food labeling considerations. The federal govern-
ment should act upon its responsibility to forge needed improvements in food safety,
based on sound science. State and local efforts, while well-intentioned, would likely
add to fear and confusion on the part of consumers, and add to food costs by serious-
ly disrupting interstate commerce.
The National Council is deeply concerned that the bill as proposed would have the
unintended effects of reducing access to critical pesticides, jeopardizing food policy
objectives and increasing food costs-without significantly increasing the safety of
our food supplies.
It would not be any single action, but rather an accumulation of individual regu-
latory decisions under the proposed system and guidelines. In particular, minor use
pesticides, which are instrumental in the production of nutritious fruits and vegeta-
bles so essential for a healthy diet, would be placed at risk. Agriculture is already
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facing serious challenges in retaining critical minor use pesticides and developing
new ones under the existing FIFRA reregistration schedule.
CONCLUSION
In closing, the National Council of Farmer Cooperatives believes that the nation
would be well served through enactment of legislation which would achieve consist-
ent and nationally uniform improvements in FFDCA and FIFRA, with consideration
of food safety needs in the broader national policy context of food policy. Legislation
must be balanced and address all key components if it is to work. By way of exam-
ple, the best designed food safety standards would constitute a failure if food short-
ages or price increases result from loss of critiôal pesticides. And, the benefits of
effective Federal pesticide standards would be severely undermined if 50 different
State standards were to follow.
We respectfully submit that while the objectives of 5. 1074 are laudable, its con-
tents must undergo significant revision to achieve the necessary balance to accom-
plish desirable food/safety policy goals.
We stand ready to work with members of this committee toward the important
objective of balanced, workable food safety legislation. We would reiterate our invi-
tation to each of you to come out and visit a cooperative and its farmer-owners, to
help you gain a better appreciation of the job we must do in producing abundant,
high quality, affordable-and we believe safe-food for the dinner tables of your
families and ours.
Thank you, Mr. Chairman, for this opportunity to present our views. We respect-
fully request that this statement be included as part of the July 10, 1991 hearing
record.
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100
80
60
40
U. S. AGRICULTURAL PRODUCTIVITY
75 YEARS OF GROWTH
C)
r
-1
ND
ND
INDEX (1977=100
1925 1935
1955
YEAR
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WORLD POPULATION GROWTH
MILLIONS
10,000 - .....~.
8,000 -
6,000 -
4,000 - /~..
2,000 -
0 - ____________________
1900 1920 1940 1960 1980 2000 2020 2040
YEAR
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Attachment 1--June 19, 1991 Testimony June 1991
FOOD POLICY IN PERSPECTIVE*
It is essential to remember that one of the primary
responsibilities of the federal government is to assure the
citizens of this country a safe, wholesome and dependable supply
of food at reasonable prices. However, because of our
international leadership, this responsibility goes even beyond
our borders to the world.
With the limitations on resources such as land and water
combined with the increased demand for food associated with
population growth and the need for improved diets, the task we
face in achieving such a food policy is enormous and should not
be taken lightly.
We have made progress meeting this policy goal. World food
production has increased at a rate of 2.5% since 1950 compared
with a population growth rate of 1.9%. This means that on a per
capita basis people have more food available to improve their
diets at a rate of .6% per year. Fortunately, about 75% of Xhis
increase has come from gains in productivity or higher output per
unit of input. With continued increases in the cost of inputs,
such productivity gains have helped hold down average unit costs
and thus the cost of food to consumers.
This is dramatically illustrated by the continued decline in
the share of income spent on food by the citizens of this
country. For example in the early 1960's U.S. citizens spent
nearly 18% of their disposable income on food. Now our citizens
spend only about 12% of their income on food. The rate of
increase in the cost of food has been less than the rate of
increase in disposable income.
This could not have been achieved without continued gains in
productivity. This is illustrated in Chart 1, which traces the
gains in productivity as we have moved from horse power to
mechanical power to science power. It is clearthat in order to
meet the continued growth in world population shown in Chart 2
with increasingly limited resources, the growth trends associated
with science power are critical for the future. Failure to do so
could have substantial implications on our ability to meet future
food needs at affordable prices.
*policy statement by National Council of Farmer Cooperatives
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-b-
Food Policy Perspective (cont.)--
To illustrate, consider the fact that the farm value of
food represented 40% of the retail cost of food in the early
1960's compared with about 25% last year. Without continued
increases in productivity and efficiency this could not have been
achi eyed.
Unfortunately, these averages do not tell the entirety of
the story that must be taken into account when considering
actions that result in less productivity and efficiency and thus
higher consumer food costs. While the average income spent on
food in the U.S. is only about 12 percent, there are 16.8 million
households in the lowest income category that spend nearly 57% of
their income on food. These households represent 32 million
people or 13% of our population.
Even with programs such as food stamps, WIC, and school
lunch, many of those in the lowest income level still have
inadequate diets and thus in many cases suffer health and disease
problems associated with malnutrition. If this is true in the
U.S. where the average income is over $20,000 per year and food
accounts for an average of only 12%, imagine the implications in
countries around the world where the population growth rate is
much higher, the average income is much lower and the share of
income spent on food is much higher.
Despite the progress we have made, agriculture must
accomplish even more. However, future gains are going to be more
difficult. World population is projected to continue to grow at
a rate of about 1.9% per year. This means that by the year 2000
there will be another 1.0 billion people that must be fed. Food
must not only be available, it must be available at affordable
prices. In order to do this we must continue to make progress in
the area of agricultural productivity.
The agricultural community has long recognized that in order
to accomplish food policy objectives on a continuing basis, the
agricultural economy and its resource base must be sustainable.
The responsible use of pesticides and other critical inputs, in a
manner that protects the environment and ensures a safe food
supply, thus has been an ongoing agricultural policy objective.
A number of proposals are now being made in the areas of
food safety, ground water and air quality that could have adverse
implications for the ability of the food industry to continue to
* make progress in meeting the food policy goal outlined above.
While everyone agrees that we should continue to make
improvements that assure safe food, clean water and clean air it
is essential that they be done in a way that also assures that
our food needs continue to be met.
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-C-
Food Policy Perspective (cont.)--
We are in peril that safety and environmental issues will be
looked at in isolation without consideration of their full
implication on food availability and cost. We cannot micro-
manage all these issues. They must be evaluated in the context
of their impact on the food system and thus on our ability to
meet the food needs of consumers at home and abroad.
Food Safety Debate
The current debate on food safety revolves around the
standards for pesticide residues and whether or not they need to
be changed.
Several important questions to consider are:
1) Are the current standards appropriate if
effectively monitored and enforced?
2) If the standards are not appropriate, then what
changes need to be made and what are the
implications for meeting our overall food policy
objecti ye?
3) Is our current system for testing and reporting
adequate?
4) Does the public understand the extent of current
safeguards the government and industry provide to
assure a safe food supply?
Given the fact that the federal government has the
responsibility to assure that our food needs are met, it is
believed that the issue of food safety should be viewed as a
major component of an overall food policy. With this in mind we
recommend the following action:
1) Charging the federal government with primary
responsibility for assuring the public that the
food industry is providing a safe, dependable
supply of high quality food and natural fiber at
reasonable prices;
2) Supporting efforts to strengthen the federal
government's food safety role, with consistent
standards for both domestically produced and
imported food (i.e. improved standards, monitoring,
and testing);
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Food Policy Perspective (cont.)--
3) Ensuring that food safety-related decisions reflect
the need for agriculture to maintain access to the
diverse range of critical crop protection chemicals
and other alternatives that are necessary to combat
aggressive and highly adaptable pests on a
sustainable basis;
4) Supporting increased research and extension
activities aimed at maintaining agriculture's
ability to provide consumers with a dependable,
safe and wholesome supply of food at reasonable
prices in an environmentally sound way;
5) Providing the necessary resources to allow the
Federal government to better communicate what is
being done to protect consumers and the public at
large with regard to the safety and wholesomeness
of our food supply.
These actions, it is believed, are essential if we as a
nation are to continue to meet our food policy objectives and if
public confidence in the safety of our food supply is to be
maintained and strengthened.
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PREPARED STATEMENT OF THE AMERICAN FROZEN FOOD INSTITUTE
The American Frozen Food Institute (AFFI) welcomes this opportunity to com-
ment on S. 1074-the Safety of Pesticides in Food Act of 1991. AFFI is the national
trade association representing frozen food processors. AFFI members produce ap-
proximately 80 percent of the nation's total yearly production of frozen foods, and
process numerous agricultural commodities that are produced with the benefit of
pesticides. Any change in the manner in which pesticide tolerances are regulated by
the Food and Drug Administration (FDA) or the Environmental Protection Agency
(EPA) would have a significant impact on the frozen food industry.
AFFI and its member companies have a long-standing commitment to the safety
of frozen foods. AFFI has consistently endorsed efforts to modernize the food safety
laws, especially as they relate to the regulation of pesticides used on raw agricultur-
al commodities and in processed foods. The goal of our food safety laws is to ensure
that safe foods are readily available to consumers while unsafe substances are not
permitted in foods or are removed from the marketplace without delay. Indeed, it is
the experience of the frozen food industry that there are either no pesticide residues
in frozen foods or the residues are well within the established tolerances. AFFI is
committed to continuing its work with other segments of the food industry to ensure
that only minimum amounts of pesticide residues are present in foods.
While reform of our food safety laws is certainly appropriate, lawmakers must
take great care to ensure that changes are based on sound, flexible scientific princi-
ples that protect the public health while not jeopardizing the availability of an
abundant, safe, and wholesome food supply. There are several proposed provisions
embodied in 5. 1074 that would promote this end-including a single negligible risk
standard applicable to both processed foods and raw agricultural commodities, and
the ability to continue marketing foods when a pesticide tolerance is modified or
revoked-and AFFI endorses these elements of the bill. AFFI, nonetheless, opposes
S. 1074 on the grounds that the bill would establish a negligible risk standard that
is unrealistic and scientifically unsound for measuring risk, would prohibit the con-
sideration of a pesticide's benefits in establishing tolerances, and would fail to estab-
lish a national uniform standard that governs the adoption of pesticide food residue
regulations.
PESTICIDE RESIDUES ON RAW AGRICULTURAL COMMODITIES AND INPRO-
CESSED FOODS SHOULD BE REGULATED UNDER THE SAME SAFETY
STANDARD
AFFI supports the provision in the proposed legislation that would regulate pesti-
cide residues both on raw agricultural commodities and in processed foods under a
single "negligible risk" standard. Evaluation of all such food tolerances should be
conducted under a unified standard which is not dependent on the form of the prod-
uct.
Under current law, EPA may establish a tolerance for a pesticide residue on a
raw agricultural commodity that is deemed safe even if the pesticide is known to be
carcinogenic but is safe nonetheless. That tolerance applies to the pesticide residue
in a processed product made from the raw agricultural commodity and will not
render the finished product adulterated. If, upon processing, the residue becomes
concentrated at a level higher than the established tolerance, however, the higher
amount is considered to be a food additive and is subject to the same safety criteria
that all food additives must satisfy. A carcinogenic pesticide residue at this higher
level must be banned, therefore, because the Delaney Clause-which prohibits the
use in food of any additive found to cause cancer in man or animals regardless of
level of risk-applies to food additives but not to pesticide residues on raw agricul-
tural commodities. This result is known as the "Delaney Paradox."
S. 1074 would provide for the establishment of tolerances for pesticide residues in
accordance with one set of criteria, consistent with the recommendations of the Na-
tional Academy of Sciences, regardless of whether the residue is on the raw agricul-
tural commodity or in the processed food. AFFI fully supports legislative efforts to
resolve the Delaney Paradox and ensure that all foods are regulated under a uni-
form standard for establishing tolerances.
"NEGLIGIBLE RISK" STANDARD SHOULD BE REDEFINED
The zero-risk standard characteristic of the Delaney Clause is simply unrealistic
and scientifically unsound in light of modern methods enabling the detection of sub-
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stances and evaluation of risk at minute levels. It is appropriate, therefore, that this
standard be replaced with a negligible risk approach whereby foods could not con-
tain pesticide residues presenting greater than "negligible risk." A negligible risk
standard has been relied upon by EPA in the context of its pesticide reregistration
and tolerance reassessment programs, and was endorsed by an expert report of the
National Academy of Sciences. AFFI opposes the negligible risk standard as pro-
posed in 5. 1074, however, because it would define that standard numerically in the
law leaving no room for EPA to exercise scientific judgment.
It is unwise public policy to cast in stone a safety standard that is inflexible. Food
safety determinations involve a number of complex factors that are unique to each
pesticide use. Flexibility in determining safe use levels for a particular pesticide is,
therefore, essential. The bill's overly proscriptive approach would preclude EPA
from exercising its independent judgment in regulating pesticide residues. In addi-
tion, an unduly restrictive safety standard could reduce the availability of many
minor use pesticides that pose less than a negligible safety risk.
The assessment of risk is a science-based inquiry subject to change as analytic
procedures and the underlying knowledge concerning health risks associated with
the use of pesticides evolves. The proposed bill would commit to statute an overly
conservative standard that would have to be continually modified and revised by
Congress if the standard were to keep pace adequately with advances in science. As
a result, the proposed standard would not enhance the safety of food and would
most certainly preclude the use of pesticides in many cases where such use would
appropriately be deemed safe under a more flexible and realistic negligible risk ap-
proach.
EPA SHOULD BE PERMITTED TO CONSIDER THE BENEFITS OF PESTICIDES
IN ESTABLISHING TOLERANCES
5. 1074 would prohibit EPA from taking into account the benefits of a pesticide,
including its effects on the costs and availability of food in establishing a tolerance
for the pesticide on the raw agricultural commodity or in the processed food. Cur-
rently, EPA is authorized by statute to consider the benefits of pesticides in setting
tolerances. This is in recognition of the useful function pesticides play in crop pro-
duction. EPA should retain the ability to consider these benefits, while at the same
time ensuring that the use of pesticides does not pose an undue public health risk.
To ignore the benefits of a pesticide is naive and contrary to the public interest.
Pesticides are used primarily to promote the growth of strong and healthy crops.
Pesticides are needed to prevent insect infestation, plant disease, and other growth
of bacteria, all of which threaten the very existence of agricultural crops. Rational
pesticide residue regulation is necessary to ensure the availability of many foods
that health officials are urging consumers to eat. Particular care must be taken to
ensure that the benefits of pesticides used on "minor use" America, are considered
as well. Most frozen foods, with the exception of crops such as corn, are considered
minor use crops and, therefore, would not be likely to receive the attention needed
from chemical manufacturers should existing products which provide important
benefits be removed from the market.
Overall, pesticides provide many important benefits to farmers, food processors,
and the ultimate consumer. These benefits are not limited to economics, but involve
nutritional quality and availability of food as well. Regulators must be permitted to
consider these benefits in setting tolerances.
EFFECTIVE FEDERAL FOOD SAFETY REGULATION REQUIRES NATIONAL
UNIFORMITY
Consistency in all food safety laws is crucial to the viability of the food industry
and the public interest. The continued ability of States to enforce different and
sometimes conflicting risk standards and, therefore prohibit the sale of foods con-
taining residue levels deemed safe by EPA, would undermine the Federal Govern-
ment's ability to regulate the food supply effectively in accordance with rules that
are predictable and uniformly applied throughout the country.
Food processors and manufacturers are, with increasing frequency, subject to a
wide range of State and local food safety laws. Often, these laws impose vastly diver-
gent requirements and make interstate shipment and sale of identical products ex-
tremely burdensome to the food manufacturing and processing industry. For exam-
ple, labels and ingredients must constantly be evaluated for compliance with vari-
ous state and local requirements. The results are consumer confusion, loss of con-
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sumer confidence in the food supply, and substantial and unjustifiable costs burden-
ing an otherwise very efficient food distribution system.
SUMMARY
Americans receive the safest and most abundant food supply in the world. Much
of the credit for this goes to the responsible use of pesticides. AFFI supports the
review of current laws to ensure that consumers continue to have available a varie-
ty of safe, wholesome, and economical foods. AFFI, nonetheless, opposes S. 1074 be-
cause it would imposed impractical risk assessment standards and prohibit the con-
sideration of important benefits in establishing pesticide tolerances. Congress should
make certain that any reforms in our food safety laws will ensure a safe, abundant
food supply. Unfortunately, S. 1074 fails to meet this objective.
PREPARED STATEMENT OF THE U.S. CHAMB'ER OF COMMERCE
The U.S. Chamber of Commerce appreciates this opportunity to express its views
on 5. 1074, the Safety of Pesticides in Food Act of 1991.
The Chamber includes among its membership all links In the food chain from
agrichemical manufacturers and other farm suppliers to growers, processors, whole-
salers, and retailers. Our perspective is the good of the food system as a whole-a
system that accounts for roughly one seventh of total gross national product, more
than 9 million jobs, and the economic well-being of hundreds of rural communities.
The ultimate link in the food chain is the consumer, whose confidence has been
shaken in recent years by a series of media reports about health risks in the food
supply-many of which involve pesticide residues.
The Chamber supports legislation to restore confidence in the food supply by har-
monizing and modernizing health and safety regulations on the basis of the best
available science. Consequently, we commend the committee for its diligent efforts
to address the " Delaney paradox" and develop a consistent risk standard for both
raw and processed foods. 5. 1074 is a step in that direction. However, we suggest
that this bill would be improved by several additions or changes.
NATIONAL UNIFORMITY
Under current law, States have the authority to set tolerances for pesticide resi-
dues in food that are more stringent than those established by EPA. This is a dis-
abling policy for domestic and international food trade. When States set tolerances
inconsistent with national standards and hose of other States, the result is con-
sumer confusion, substantial disruption of interstate commerce, and complications
in international trade. We learned this lesson at great cost during the ethylene di-
bromide (EDB) incident of 1983.
States are an important factor in the food safety equation, and their considerable
personnel and technological resources are needed to help regulate the food supply.
For this reason, States should be allowed to participate in the national, science-
based process of tolerance-setting. However, States should not have authority to set
inconsistent tolerances, except where special local circumstances dictate. The Cham-
ber supports adoption of the President's proposal, outlined in his 1989 Food Safety
Plan, that national uniformity for tolerances be established. We respectfully urge
the committee to make this provision a part of 5. 1074.
NEGLIBLE RISK AND RISK ASSESSMENT
5. 1074 recognizes that the 1950'sra science reflected in the "zero risk" Delaney
Clause cannot be applied constructively in today's scientific context. In its place, S.
1074 substitutes a negligible-risk standard of one-in-one million probability of cancer
over a lifetime of exposure. This definition of negligible risk should serve as a target
or benchmark rather than a statutory mandate. At present, cancer risk assessment
involves extrapolations from animal studies based on a string of conservative as-
sumptions about the shape of the dose response curve at very low doses. Flexibility
is needed, not only to accommodate future advances in the ever-evolving science of
risk assessment, but also to give regulators discretion to factor in their non-quantifi-
able professional judgements and experience. This discretion does not imply a lower-
ing of standards. In some cases, it may result in the rejection of a product that oth-
erwise would have to be approved under the numerical standard imposed in 5. 1074.
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A related concern is the use of even more conservative risk-assessment guidelines.
Under S. 1074, regulators would have to assume that all pesticides approved for use
on a crop have been used and that residues are present at full tolerance levels. This
is rarely the case in practice. If these extremely conservative guidelines are adopted,
regulators will need a measure of flexibility in determining risk. Otherwise, many
safe products will be eliminated from the food production system.
CONSIDERATION OF BENEFITS
S. 1074 would not allow consideration of benefits-even health and nutrition bene-
fits-in tolerance determination. Pesticides have made it possible to provide con-
sumers with a nutrient-rich diet of fruits, vegetables, ad fiber throughout the year
at affordable prices. These benefits should continue to be taken into account.
IMPACT ON MINOR-USE PESTICIDES
Minor-use pesticides are essential to crop production. Without the availability of
these low-volume, low-profit products, fruit, vegetable and other specialty crop grow-
ers will be in severe jeopardy. During recent congressional hearings on implementa-
tion of the 1988 FIFRA amendments, we learned that the reregistration process
mandated by those amendments is having an unintended adverse impact on minor-
use pesticides. Because of the high costs associated with reregistration of these low-
revenue-producing products, many manufacturers are deciding not to reregister
their minor-use products, resulting in their cancellation.I11S. 1074 would uninten-
tionally add to the problem of minor-use pesticides by substantially increasing the
manufacturers' costs of securing and maintaining minor-use registrations. The bill
would require the payment of fees, including annual maintenance fees, to cover all
EPA costs associated with issuing and reevaluating pesticide tolerances.
CONCLUSION
The Chamber supports the Committee's efforts to address the Delaney Clause and
resolve conflicts and inconsistencies in the regulation of pesticide residues, but we
cannot support 5. 1074 in its present form. We respectfully urge you to consider the
problems discussed above and make the needed improvements during the mark-up
process.
Thank you for this opportunity to comment upon 5. 1074, the Safety of Pesticides
in Food Act of 1991.
PREPARED STATEMENT OF THE UNITED FRESH FRUIT AND VEGETABLE ASSOCIATION
The United Fresh Fruit and Vegetable Association is the national trade organiza-
tion representing all sectors of the fresh fruit and vegetable industry. Founded in
1904, United's core membership represents over 2,100 member companies through-
out the United States. Our membership consists of grower/shippers, wholesalers,
importers, exporters, retailers and foodservice operators.
The United Fresh Fruit and Vegetable Association appreciates the opportunity to
submit written comments expounding our views on the "Safety of Pesticides in Food
Act of 1991," which has a direct impact on the fruit and vegetable industry and are
sorry we were not able to testify orally before the committee. Our association fully
supports the passage of new food safety legislation to assure American consumers a
safe, wholesome, and plentiful food supply, to give our regulatory agencies necessary
authority to remove hazardous pesticides from the market in an expedient manner,
and to assure fruit and vegetable producers and marketers a more placid and pre-
dictable future. Although 5. 1074 addresses the safety of pesticides in foods, it's pro-
visions as currently written create very real concern in the minds of many in the
produce industry. The following paragraphs will highlight a few of these misgivings.
First, the fresh fruit and vegetable industry must maintain and even regain the
confidence of the American public. The recent wave of food scares has devastated
parts of our industry and created a credibility gap that is resistant to repair. It is
the responsibility of the food industry to provide an array of safe, healthful, nutri-
tious, and affordable foods to the marketplace. It is the responsibility of government
to set stern, uniform standards which define the safety of the food we grow and
supply to the American public. A necessary balance is needed.
Second, we must clearly define what constitutes a real versus a theoretical health
risk. Risk determinations must be based on sound science and realistic exposure es-
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timates. As mandated by FIFRA `88, the EPA is requiring that substantial amounts
of new data be submitted in its efforts to re-examine the safety of older chemicals.
These new studies are replacing older, less sophisticated ones. New, more sensitive,
methods of detecting pesticide residues in food are replacing mathematical model-
ing. Market basket surveys are replacing field residue studies to estimate pesticide
residues "at the dinner plate." The EPA is asking our growers for benefit and use
information to be incorporated into its regulatory decision-making. Clearly, the
trend is moving toward making regulatory decisions based on more realistic assump-
tions.
Third, we need to set uniform risk standards while retaining the flexibility
needed to make balanced decisions. We support replacing the antiquated Delaney
Clause with a uniform negligible risk standard, but we oppose assigning a specific
number of definition of risk to it. Such a restriction would disallow consideration of
future technological advances in pesticide detection and would prevent EPA from
making regulatory risk decisions on a case-by-case basis-taking into account pesti-
cide benefits-thus potentially resulting in the loss of valuable pesticides used on
fresh fruit and vegetable crops.
Fourth, we advocate a national pesticide tolerance uniformity provision to pre-
empt State laws that conflict or differ with national standards. We cannot win the
confidence of the American public if every State has a different "allowable limit of
pesticide reside" on commodities they grow. Nor can we realistically expect to
market across State or national boundaries. The legislation should also preempt in-
discriminate use of health and safety warnings which undermine the safety of our
food supply.
Fifth, we agree that the EPA should be allowed to move quickly to remove haz-
ardous pesticides from the market without being endlessly fettered in regulatory red
tape. We generally support streamlining the cancellation procedure by replacing the
lengthy hearing process with a notice and comment period. However, when a toler-
ance is revoked we concur with you that a "pipeline" provision be provided to allow
for the marketing of a legally treated food.
We support suspension authority but stress that this vehicle should only be used
in situations where there is a true "imminent hazard" objectively identified by the
best available science. Misuse of this regulatory tool would create unnecessary
public hysteria and result in unjustified damage to the promotion and marketing of
otherwise safe and healthy produce.
And last, we fully support legislation that would provide necessary assistance to
our members who produce "minor crops." As a result of FIFRA `88, many chemical
producers (lacking financial incentives to produce data and pay fees for small
volume chemicals) are dropping registrations for chemicals that our industry must
have. We generally advocate reducing data requirements for minor use crops, com-
bining data requirements, waiving fees, and providing the opportunity for grower
groups to become registrants themselves. Your bill would increase fees for tolerance
and maintenance registrations and would give EPA authority, at any time, to re-
quire additional health and safety data to support tolerances. A provision such as
this would result in even more pesticides for minor crops disappearing from the
marketplace.
These are changes our industry advocates in a comprehensive food safety bill. If
we are to continue to enjoy a safe and varied array of fresh fruits and vegetables,
we must act now to ensure that our standards remain consistently high; that our
growers are given the support they need to produce safe, quality produce; and that
our regulatory system is strong, yet flexible. Again we appreciate the opportunity to
submit written comments to this committee. We look forward to working with you
in crafting legislation that addresses all our concerns.
The CHAIRMAN. The committee stands in recess.
[Whereupon, at 12:30 p.m., the committee was adjourned.]
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