Full text of "The Federal Insecticide, Fungicide and Rodenticide Act (S. 958, S. 1478, and S. 2050) : hearing before the Subcommittee on Agricultural Research, Conservation, Forestry, and General Legislation of the Committee on Agriculture, Nutrition, and Forestry, United States Senate, One Hundred Third Congress, first session ... July 28, 1994"

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\\\/ S. Hrg. 103-1065

^ THE FEDERAL INSECTICIDE, FUNGICIDE AND

RODENTICIDE ACT (S. 958, S. 1478, AND
S. 2050)

Y 4. AG 8/3: S. HRG. 103-1065 =^^=^^=^

The Federal Insecticide! Fungicide... ore the

SUBCOMMITTEE ON

AGRICULTURAL RESEARCH, CONSERVATION,

FORESTRY, AND GENERAL LEGISLATION

OF THE

COMMITTEE ON AGRICULTURE,

NUTRITION, AND FORESTRY

UNITED STATES SENATE

ONE HUNDRED THIRD CONGRESS

SECOND SESSION

THE FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT

JULY 28, 1994

Printed for the use oft
Committee on Agriculture, Nutritil

NTING OFFICE' ///*/..,V "' L IHCiA fv

20-127 CC WASHINGTON : 1995 -^^t^^Ef\}rS HtS^'MW

U.S. GOVERNMENT PRINTING

For sale by the U.S. Government Printing Office

Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0-16-052077-0

S. Hrg. 103-1065

THE FEDERAL INSECTICIDE, FUNGICIDE AND
RODENTICIDE ACT ^. 958, S. 1478, AND
S. 2050)

f 4. A5 8/3: S. HRG. 103-1065

he Federal Insecticide. Fungicide... ore the

SUBCOMMITTEE ON

AGRICULTURAL RESEARCH, CONSERVATION,

FORESTRY, AND GENERAL LEGISLATION

OF THE

COMMITTEE ON AGRICULTURE,

NUTRITION, AND FORESTRY

UNITED STATES SENATE

ONE HUNDRED THIRD CONGRESS

SECOND SESSION

THE FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICmE ACT

JULY 28. 1994

F*rinted for the use of^
Committee on Agriculture, Nutritii

U.S. GOVERNMENT PRINTING .OFFI<?&- ;?//l/..~|*' "/ Cll^t^ArS
20-127 CC WASHINGTON : 1995 ^'^--^^-^^TSnCnJI^fS

For sale by the U.S. Govemmenl Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-052077-0

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY

PATRICK J.

DAVID H. PRYOR, Arkansas

DAVID L. BOREN, Oklahoma

HOWELL HEFLIN, Alabama

TOM HARKIN, Iowa

KENT CONRAD, North Dakota

THOMAS A. DASCHLE. South Dakota

MAX BAUCUS, Montana

J. ROBERT KERREY, Nebraska

RUSSELL D. FEINGOLD, Wisconsin

LEAHY, Vermont, Chairman

RICHARD G. LUGAR, Indiana
ROBERT DOLE, Kansas
JESSE HELMS, North Carohna
THAD COCHRAN, Mississippi
MITCH McCONNT:LL, Kentucky
LARRY E. CRAIG, Idaho
PAUL COVERDELL, Georgia
CHARLES E. GRASSLEY, Iowa

Subcommittee on Agricultural Research, Conservation, Forectry, and

General Legislation

THOMAS A. DASCHLE, South Dakota, Chairman

J. ROBERT KERREY, Nebraska
TOM HARKIN, Iowa

LARRY E. CRAIG, Idaho
THAD COCHRAN, Mississippi

(II)

-A ?■

iiL

CONTENTS

Page
Statements

Hon. Thomas A. Daschle, U.S. Senator from South Dakota 1

Hon. Larry E. Craig, U.S. Senator from Idaho 3

Prepared statement 4

Hon. Richard G. Lugar, U.S. Senator from Indiana 5

Hon. Thad Cochran, U.S. Senator from Mississippi, prepared statement ... 6

Hon. David Piyor, U.S. Senator from Arkansas 8

Prepared statement 8

Carolyn Brickey, executive director, National Campaign for Pesticide Pol-
icy Reform, Washington, DC 6

Albert H. MeyerhofT, senior attorney. Natural Resources Defense Council,

San Francisco, CA 9

Jay J. Vroom, president. National Agricultural Chemicals Association,

Washington, DC 11

Philip J. Landrigan, M.D., chairman, Committee on Pesticide in the
Diets of Infants and Children, National Research Council, New York,

NY 13

Stephen A. Ziller, Ph.D., vice president for Science and Technology, Gro-
cery Manufacturers of America, Inc., Washington, DC 15

Juanita Duggan, senior vice president. Government Affairs, National

Food Processors Association, Washington, DC 17

Jim Bender, farmer and author of the Book "Future Harvest", Weeping

Water, NE 19

Keith W. Eckel, farmer and president of the Pennsylvania Farm Bureau

Federation, Clarks Summit, PA 20

APPENDDC

Prepared Statements

Carolyn Brickey 43

Albert H. Meyerhoff and Jennifer Curtis 48

Jay J. Vroom 54

Philip J. Landrigan 63

Stephen A. Ziller 66

Juanita Duggan 68

Jim Bender 73

Keith W. Eckel 74

Ralph Enger 83

Christian Schlect and Mark Maslyn 88

William C. Balek 93

Warren E. Stickle 100

Position Statements

National Association of State Department of Agriculture 123

National Cotton Council of America 128

Additional material submitted for the record

Senators Helms's questions for Dr. Kessler with responses thereto 129

Establishing a Nicotine Threshold for Addiction 135

Letters 138

National Agricultural Chemicals Association 138

United States Environmental Protection Agency 139

Food Safe Program 144

(III)

THE FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT (S. 958, S. 1478, AND S. 2050)

THURSDAY, JULY 28, 1994

U.S. Senate,
Subcommittee on Agricultural Research,
Conservation, Forestry and General Legislation, of
THE Committee on Agriculture, Nutrition, and

Forestry,
Washington, DC.

The subcommittee met, pursuant to notice, at 2:30 p.m., in room
SR-332, Russell Senate Office Building, Hon. Thomas A. Daschle,
Chairman of the subcommittee, presiding.

Present or submitting a statement: Senators Daschle, Pryor,
Lugar, Cochran, and Craig.

STATEMENT OF HON. THOMAS A. DASCHLE, A U.S. SENATOR

FROM SOUTH DAKOTA

Senator Daschle. The hearing will come to order.

Today we meet to gather information for our deliberations on
the reauthorization of the Federal Insecticide, Fungicide, and
Rodenticide Act and also certain provisions of the Federal Food,
Drug and Cosmetic Act.

FIFRA is always a topic of great public concern, and that is as
it should be. Nothing is more fundamental to the quality and quan-
tity of human life than an assured supply of wholesome, appetizing
food. The one near certainty in life is that food will be both a fun-
damental need and a fundamental pleasure for most people.

In America, we are generally fortunate. We do not suffer through
the periodic famines that affiict too much of humanity. That bless-
ing is a tribute both to our natural environment and the unnatural
productivity that allows a tiny fraction of our population to feed not
only our Nation, but to help feed people in other Nations as well.

Indeed, the fruits of the Earth remain the single largest category
in our favor in international trade. Sometimes we tend to forget
that fact.

It is our technology as well as our hardworking farmers who
apply that technology that make all of this possible. However, tech-
nology has the capacity to create ill as well as good if we do not
maintain our vigilance.

That is why FIFRA and FFDCA were created, and why they re-
main essential.

Our technology evolves swiftly, sometimes too swiftly for legisla-
tors and even producers to keep pace. Now we need to reex-
amine our agricultural technology with the purpose of keeping

(1)

our farmers the world's most productive and keeping our agricul-
tural technology the world's best.

The first imperative is safeguarding human health through as-
suring the safety of American food supply.

A great concern in this regard is whether present standards ade-
quately protect infants and children. Children are not just little
adults. They are unique in diet and physiology.

This fact was not taken into account in existing law, some provi-
sions which date back to the 1940's and 1950's. Now we know bet-
ter. The question for us as legislators is what constitutes an ade-
quate standard for food safety for children.

Is it the same standard as applies to adults, or is it a more con-
servative benchmark? Does a sufficient safety margin exist, or
must the margins be withdrawn? That is a fundamental consider-
ation that we must address today that we did not have to address
in the past. On the other hand, there are other considerations —
dozens of them. For with knowledge comes responsibility.

Notably, today's considerations include environmental, enforce-
ment, and economic concerns. Considering the environment we
must ask whether legislation is adequate to encourage and expe-
dite replacing more dangerous pesticides with more benign modern
compounds and with earth -friendly farming practices.

We must ask: "How do we encourage rather than impede the
shift to improved or alternative technologies that both produce '
foods we need and better protect the entire ecosystems that include ;
the cultivated lands that sustain our Nation?" We must decide
whether we are being over- or under-zealous in setting residue re-
quirements for food.

Considering the requirements of producers we must decide how
to speed the registration of much needed minor-use pesticides to
give them the tools they need to produce the foods Americans de-
mand.

The situation regarding the unavailability of minor-use pesticides
is a major problem for those who work on the land.

We must decide whether the rules we enact will make us part-
ners or parole officers to America's farmers. Also, I am certain that
my fellow legislators prefer partnership.

This philosophy also holds true for the industries that sup-
port our agricultural producers and deliver our food products to
con-
sumers. We must make decisions on sound scientific bases and in
ways that minimize economic dislocation. We face many decisions.
We must decide what constitutes "negligible risks" in pesticide resi-
dues, and whether to mandate "zero risk" in some instances.

We must deliberate about the Delaney clause with its mandate
of zero risk ia regard to some carcinogenic compounds. Should we
choose between multiple risk measurements and standards which
ensure food safety, or simpler standards that measure pesticide
residues at a single point in the chain of food production and prep-
aration.

These are tough issues. We are fortunate to have a panel of
distinguished witnesses to guide and help us in our delibera-
tions. I thank each of them for their time and effort, for their prep-

aration and their travel, for the sacrifices that they made to be
with us today.

Testifying are Carolyn Brickey, the executive director of the Na-
tional Campaign for Pesticide Policy Reform; Jay Vroom, the presi-
dent of the National Agricultural Chemicals Association; Dr. Philip
Landrigan, the chairman of the National Academy of Sciences
Committee on pesticides in the Diets of Infants and Children; Dr.
Stephen Ziller, vice president of Scientific and Technical Affairs for
the Grocery Manufacturers of America; Albert Meyerhoff, a senior
attorney for the National — or excuse me — the Natural Resources
Defense Council; Juanita Duggan, the senior vice president for
Government Affairs of the National Food Processors Association;
Jim Bender a farmer from Weeping Water, Nebraska and author
of the book ''Future Harvest"; and Keith Eckel, a farmer from
Clarks Summit, PA and the president of the Pennsylvania Farm
Bureau Federation.

Let me invite all of them to our table this afternoon and as they
are coming to the table let me call upon my Colleague and friend
from Idaho, the Ranking Member in this subcommittee, Larry
Craig.

STATEMENT OF HON. LARRY E. CRAIG, A U.S. SENATOR

FROM roAHO

Senator Craig. Mr. Chairman, thank you very much. Please do
come up and take your seats so that the Chairman can move us
expeditiously. I want to thank you and the Chairman of the Full
Committee for bringing this panel together and holding this hear-
ing.

Mr. Chairman, while I think all of us recognize the importance
of this hearing I hope that we continue to focus on the goal at
hand. Also, that goal is, I think one that all of us share; to ensure
an adequate wholesome and economical food supply for our country
that we can without reservation not only provide the American
consumer, but continue to share with all the world.

Now, when I say that, Mr. Chairman, I think it is very important
that I quote two gentlemen who I have some respect for in the
work they have in areas of safe food, and understanding of pes-
ticides and the issue of chemicals. The Farm Bureau folks quoted
Dr. C. Everett Koop in the hearings in the House and this was the
quote. I thought it was significant. Dr. Koop said: "I do not know
of a single instance where exposure to pesticides on foods in the
marketplace is a source of any danger to children or adults." He
says: "It's a risk of zero."

Dr. Bruce Ames, the University of California at Berkeley says:
"The attempt to prevent cancer by regulating low levels of syn-
thetic chemicals by using worst-case, one-in-a-million risk scenarios
is not scientifically justified. It diverts resources from much more
important risks. Perversely it decreases consumption of food that
might even prevent cancer."

Therefore, I think there are several issues that must be ad-
dressed as we look toward resolving our concerns. The legislation
before us that these ladies and gentlemen will speak to today along
with their own knowledge attempts to address that in a variety of

ways. I'm a supporter of S. 1478 that Senator Lugar, who has just
arrived along with Senator Pryor, have introduced.

Clearly I think, Mr, Chairman, the Delaney clause and FIFRA
section 408 and the contradictions amongst tnose two items have
got to be resolved. Single regulatory standards for fresh and proc-
essed products is an issue that has to be resolved. Length of time
to remove unsafe pesticides as well as approval for newer, safer
products as technology has developed is an issue of importance.

The loss of minor-use pesticides must be resolved.

I come from a State that has a variety of counties that really pro-
vide unique products to the country in the sense of great supplies
of seeds and a variety of food products. Minor-use pesticides are
very important to the well being of those economies by providing
for them and the variable risk benefits considerations that I think
have to be developed. There is a lot to be talked about.

I thank you for calling the hearing. Those are some of my con-
cerns and I would ask unanimous consent that my full statement
become a part of the record.

Senator Daschle. Without objection. Thank you Senator Craig.

[The prepared statement of Senator Craig follows:]

STATEMENT OF SENATOR LARRY E. CRAIG

Mr. Chairman, I would like to thank you for calling this additional hearing. This
is a very important subject and there are many outstanding issues facing American
agriculture and the general public as it relates to the safe and effective use of
chemicals.

I believe, Mr. Chairman, that as we examine this issue we must keep our focus
on the goal. That goal, I believe all share, to ensure that we maintain an adequate,
wholesome and economical food supply that we can, without reservation, not only
provide for the American consumer, but continue to share with the world.

Statements by two recognized professionals, as quoted by Mark Maslyn of the
American Farm Bureau in the House Agriculture Hearing on June 15, could b»e in-
structive to this committee as well:

Dr. C. Everett Koop:

"/ do not know of a single instance where exposure to pesticides on foods in
the marketplace is a source of any danger to children or adults. It's a risk
of zero.

And Dr. Bruce Ames of the University of California at Berkeley:

"The attempt to prevent cancer by regulating low levels of synthetic chemi-
cals by using worst-case, one-in-one million risk scenarios is not scientif-
ically justified. It diverts resources from much more important risks. Per-
versely, it decreases consumption of foods that help to prevent cancer."

There are several issues that must be addressed as we look to resolving this issue:

1. The Delaney clause and FIFRA section 408 contradiction must be re-
solved.

2. Single regulator standards for fresh and process products.

3. Length of time to remove unsafe pesticides as well as approval of
newer, safer products as technologies are developed.

4. The loss of "minor-use" pesticides must be resolved.

5. A viable risk-benefit consideration must be developed.

I have joined with Senators Pryor and Lugar in cosponsoring S. 1478, in an at-
tempted to address these issues.

On the other hand, it appears to me that the administration's approach to resolv-
ing these issues seems to be shifting the burden from the Federal bureaucrats onto
the backs of the individuals it regulates. For example, as I read the administration
proposal, if registration is not renewed by the end of a 15-year deadline, a 1-year
extension could be granted. At the end of that year, the registration would dis-
appear. The effect would be that if EPA fails to act, or if its own roadblocks prevent

the registrant from meeting the deadline, farmers lose the use of safe chemical prod-
ucts and consumers suffer as well. This is a major shift in responsibility.

The administration's pesticide policy proposal would extend current Farm bill pes-
ticide recordkeeping requirements on restricted use chemicals to all chemicals, for
farmers only. At the same time, the proposal would amend the Federal Food, Drug
and Cosmetic Act. The EPA would be required to assess and identify nondietary ex-
posure in the home, water, lawn, work place, and elsewhere, and include these expo-
sures in setting food use tolerances. Agriculture's ability to use a chemical on a
farm, where it can be controlled and measured, would ultimately be limited by other
uses which cannot be controlled or measured on a national basis.

These are important issues before the committee. I look forward to the testimony
of the witnesses and working with the Chairman and other Members of this com-
mittee to resolve the outstanding issues.

Thank you, Mr. Chairman.

Senator Daschle. Our Ranking Member of the Full Committee
is here, Senator Lugar, and I would invite him for any opening re-
marks that he would like to make.

STATEMENT OF HON. RICHARD G. LUGAR, A U.S. SENATOR

FROM INDIANA

Senator Lugar. Thank you very much, Mr. Chairman. I am
pleased to join you and my Colleague, the Senator from Idaho, and
I congratulate you as he does in holding the hearing and taking
testimony on the administration's food safety legislation introduced
by the Chairman of our committee. Senator Leahy and Senator
Kennedy, as well as your consideration of the food safety legislation
which Senator Pryor and I have introduced.

The Senate Agriculture Committee recently heard testimony
from administration witnesses with regard to food safety legisla-
tion. At that hearing, I expressed some concerns with several provi-
sions of the administration's proposal and contrasted that approach
with the Pryor/Lugar legislation. I will not go into the same detail
today, but would note a few differences that are major, I believe,
for the record.

In reforming the Delaney clause we need a science-based, neg-
ligible-risk standard such as that found in S. 1478 which would
give the EPA flexibility to take into account advances in science
when making tolerance decisions. Our bill also allows for the con-
sideration of benefits in setting tolerances and recognizes the role
of pesticides in ensuring an adequate, wholesome, and economical
food supply.

Finally, S. 1478 does address the issues raised in last year's Na-
tional Academy of Sciences Report about pesticides in the diets of
infants and children. The bill directs EPA, FDA, and USDA to im-
plement the recommendations of the report recognizing the need
for obtaining better information on what children eat and what is
in the food they consume.

While we can always work for improvements, it is important to
note that our food supply in this country is safe, that our Nation's
consumers have access to a varied and abundant array of food.

Again, I appreciate the subcommittee holding the hearing and I
look forward to being a part of this hearing today. Thank you, Mr.
Chairman.

Senator Daschle. Thank you. Sir.

Senator Craig. Mr. Chairman, could I ask unanimous consent
also that a statement by Senator Cochran become part of the
record?

Senator Daschle, By all means.

[The prepared statement of Senator Cochran follows:]

STATEMENT OF SENATOR THAD COCHRAN

Thank you, Mr. Chairman for holding this hearing to address a very important
issue. This committee is interested in a commitment to insure that the citizens of
the United States have access to safe and wholesome food. We must base our ac-
tions and our decisions on the facts and reliable research.

I hope that we will be able to use resources, private and public to provide sound
scientific information concerning the food and agricultural policy impacts of the var-
ious pesticide reform proposals.

Consumer fears about the health risks of food have often been influenced by sen-
sational reports, which have not always been based upon sound science.

As this committee begins to address pesticide and food safety reform legislation,
we must not lose sight of its impact on farm income and productivity, while insuring
that our consumers have the safest and most abundant choices of food products.

I look forward to working with the committee, the administration, and with the
various sectors of the food and agricultural community in addressing legislation to
make the safest food supply in the world even safer. I have no doubt that this can
be accomplished without adversely impacting U.S. agricultural production if we are
all committed to working together and base our decisions on sound science.

Thank you again, Mr. Chairman for holding this hearing. I look forward to the
testimony presented here today.

Senator Daschle. We will now proceed with our panel. Let me
begin by welcoming back to this committee someone who is no
stranger, Carolyn Brickey.

STATEMENT OF CAROLYN BRICKEY, EXECUTIVE DIRECTOR,
NATIONAL CAMPAIGN FOR PESTICIDE POLICY REFORM,
WASHINGTON, DC.

Ms. Brickey. Thank you, Mr. Chairman. It is a pleasure to ap-
pear before what has to be the most distinguished committee in
this Congress, and I say that without any bias whatsoever.

Thank you for an opportunity to present the views of the Na-
tional Campaign for Pesticide Policy Reform about the administra-
tion's proposal and other proposals. I am the executive director of
the campaign which is a clearing house for a coalition of 51 local
and national groups including consumer advocacy, environmental,
health, women's civil rights, and pesticide reform organizations.

I am submitting written remarks on the specifics of the legisla-
tion, but I would like to talk more generally about the problems
posed by pesticides and what we need to do to fix the problems.

First of all, why are pesticides a problem and why do we need
to worry about this? Pesticides by definition are fairly dangerous
substances because they are designed to kill living things such as
insects or weeds. As one farmer told me years ago: ''If it don't kill
bugs. Missy, it don't work."

This is Pesticides 101 as far as I am concerned. Sometimes when
pesticides do work they can be potent carcinogens. Research has
shown us that others can cause birth defects, damage to central
nervous system, the immune system or reproductive organs. Some
pesticides have been linked in research to breast cancer in humans
while others interfere with hormonal function and may be associ-

ated with the substantial increases in cancer of the reproductive or-
gans that have occurred over the last 30 years.

Some studies of children born in areas with high pesticide use
suggest higher rates of limb abnormalities in newborns. Other
studies indicate that pesticide use in homes and gardens is related
to a seven-fold increase in the risk of childhood leukemia.

Just as canaries were used to signal that the air in the coal
mines was dangerous to miners, the disturbing events in the repro-
ductive health of wildlife including eagles, alligators, and fish may
be a signal that some pesticides pose a serious threat to human
health over a long period of time.

Meanwhile, EPA regulates exposure to pesticides as though peo-
ple were exposed to one pesticide at a time. In fact, we are all ex-
posed to mixtures of pesticides in our food each day and in our en-
vironment. The health effects of all these pesticides is not known.

As parents you and I make a point of feeding our children fruits
and vegetables as part of a balanced healthy diet and we should.

Yet, according to the National Academy of Sciences, children are
at a greater risk for exposure to pesticides, not only because they
eat a lot more fruits and vegetables than adults per unit of body
weight, but also because of their biological sensitivity. All of their
maior organ systems are still developing, and a child's developing
body is often highly susceptible to damage by the chemicals in pes-
ticides.

Several different pesticides can be found in a single serving of
many foods commonly eaten by children such as apples, bananas,
strawberries, peaches, pears, or potatoes. In many parts of the
country, particularly in the midwest, drinking water supplies are
also contaminated with certain pesticides.

According to data collected by USDA and analyzed by the Envi-
ronmental Group, in certain instances, up to eight different waxing
pesticides have been found on certain fruits and vegetables even
after washing, peeling, and coring the fruits and vegetables. This
means you cannot always wash the stuff off. Unfortunately, the
Government does not currently regulate pesticides on the basis of
health considerations alone, nor does the Government regulate pes-
ticides to specifically protect children.

So, what is the solution? There are five things that need to be
done if we are going to implement comprehensive, effective pes-
ticide reform and wean ourselves from our chemical dependency.
First, there should be a health based standard for raw and proc-
essed food. Only a true lack of alternatives to pesticides or an
averted health risk should ever be considered when EPA says that
a pesticide is actually unsafe; that is, that it exceeds the health
standard.

Mr. Chairman, we are not talking about whether pesticides have
inherent benefits when they are approved for use. We are, instead,
talking about whether more narrow economic consideration should
prevail over health risks.

Second, pesticides must be regulated based on the cumulative
risk they pose. The risks associated with different pesticides that
cause the same health effects can be added together in some in-
stances. For example, if a strawberry has eight different pesticides
on it and four of them have neurotoxic effects, perhaps those effects

should be added together as a cumulative effect rather than being
looked at individually.

In addition, we need to consider multiple exposures to pesticides
not just from food. We drink them in water and our children crawl
around them on our carpets when we exterminate our homes.
Clearly we are exposed to more than minuscule amounts of pes-
ticides in our daily lives.

Third, we need to make EPA's job easier — not because the Agen-
cy is incompetent — it is not — but because there are insufficient re-
sources to overcome a series of regulatory obstacles that the Agen-
cy faces in enforcing the law. The impediments that EPA staff face
in the current law drain the resources and prevent them from get-
ting their work done. The program is a paperwork treadmill, and
the objective becomes managing the paper and not the risk.

Fourth, we need to reduce the overall use of pesticides. Some
farmers have already begun to do this as you will hear from Mr.
Bender today. The best way to make this happen is to have suc-
cessful farmers teach other farmers in their own areas how to re-
duce their use of pesticides.

Some research that we are doing at the National Campaign indi-
cates that the American public is very much behind this idea, Mr.
Chairman. They see the train moving forward, they want to see
progress in this area, and they want to see the levels of pesticides
that people use reduced.

I believe it is important if we are going to talk about substantial
progress in sustainable agriculture to attack the chemical inputs
directly and try to reduce them. Or else the green payment pro-
grams that this committee may explore in the Farm bill will not
do anything meaningful to improve the environment.

Thank you very much.

Senator Daschle. Thank you very much, Carolyn.

As you were presenting your testimony our Colleague from Ar-
kansas and dear friend, David Pryor, has arrived and I would in-
vite him to make any remarks.

Senator Pryor. Tom, let me wait until the witnesses have spo-
ken, and I will be glad to chime in after that.

Senator Daschle. OK Very good.

Senator Pryor. Thank you for calling these hearings, Sir. Thank
you.

[The prepared statement of Senator Pryor follows:]

STATEMENT OF SENATOR DAVID PRYOR

I want to commend Senator Daschle for calling today's hearing on proposed pes-
ticide reform legislation. He and his staff have shown tremendous leadership on this
and many other critical issues facing this country and especially this country's agri-
culture sector.

Today, we are once again looking at just one of those critical issues. Farmers all
across this country are standing by, helplessly watching, as one after another safe
and effective tool to defend their crops is taken away. This circumstance is not oc-
curring because these tools pose a significant risk, but because of a now well-known
provision of law known as the Delaney clause.

As I said at the last hearing, I hope we will all work together on this and not
turn it into a white hat/black nat issue. Afterall, there are so many places where
I believe most of us can agree. For example, we all agree that FIFRA must be re-
formed to give EPA the ability to quickly remove those chemicals from the market-
place that are found to be unacceptable.

Last September, I, along with Senator Lugar and several other Members of the
Agriculture Committee, introduced the Food Quality Protection Act of 1993, S. 1478.

As recommended by the National Academy of Sciences (NAS) report, The Delaney
Paradox, our bill would repeal the Delaney clause and establish a single negligible
risk standard applicable to both raw and processed foods. The Pryor-Lugar bill also
retains the consideration of risk assessment in the important decisions of consumer
and health benefits — which are only made possible by an adequate, wholesome, and
economical food supply. Our bill contains a directive to EPA to implement the rec-
ommendations of the NAS study. Pesticides in the Diets of Infants and Children. As
I understand it, this is the only food safety bill that requires the EPA to implement
the complete list of NAS recommendations. In addition, the bill would establish na-
tional uniformity of pesticide tolerances in order to preserve our national market for
food products moving in interstate commerce. Perhaps most importantly, the bill
significantly streamlines the cancellation and suspension procedures in FIFRA so
that truly harmful chemicals can be removed quicKly from the marketplace, while
maintaining appropriate scientific review and opportunities for public participation
in cancellation proceedings.

I introduced this bill in order to address the essential features of the law needed
to resolve the Delaney clause issues. The scope of the bill is by design limited to
eight or nine major elements. My purpose is to bring balance to the debate as we
attempt to weigh, on the one hand, the need to have available, safe, effective crop
protection tools that have helped create ard sustain the safest food supply and the
most productive agricultural economy in the world, and on the other hand, the need
to protect the public health — Particularly children.

Mr. Chairman, thanks again for calling this hearing. I look forward to hearing
from our distinguished panel of witnesses, as well as continuing to work with all
interested parties on this vital issue.

Senator Daschle. And Now, our second witness, as I indicated
earlier, is the senior attorney of the Natural Resources Defense
Council — Albert Meyerhoff.

Mr. Meyerhoff, thank you for being here,

STATEMENT OF ALBERT H. MEYERHOFF, SENIOR ATTORNEY,
NATURAL RESOURCES DEFENSE COUNCIL, SAN FRANCISCO,
CA

Mr. Meyerhoff. Thanks very much. Senator. I will try to keep
these remarks brief so we will have some time. However, I would
ask that the written testimony be part of the record.

Senator Daschle. Without objection, the entire statement will be
made a part of the record.

Mr. Meyerhoff. I have been working on issues involving pes-
ticides for about 20 years. The other night, I was reading the floor
debates from 1954 to 1958, when the Pesticide Residue Amend-
ment and the Delaney clause was enacted. I must have just not
had a good book or something, but I was reading through them and
what I found rather intriguing was that many of the same issues
that we are debating here today, the same questions were at issue
then: How safe is safe? Do we need pesticides? How many? Where?
What about the water? What about the wildlife? What about the
workers? Whiat about the farmers? The Farm Bureau, the National
Agricultural Chemicals Association, environmental groups, opposite
poles fighting with each other, still fighting with each other 35
years later. I am not sure if that is a comment on organizations
like mine, the industry, the process, whatever, but we are not effec-
tively finding solutions.

Senator Lugar will remember that I participated in 1986 in nego-
tiations between the industry and a coalition of environmental and
labor and consumer organizations where we found common ground
on a variety of testing issues. Much of the debate then, as it is now.

was what are the health effects of these chemicals. Because they
had not been fully tested and many of them still have not been,
now, as the data is coming in, I think the debate is moving to what
do we do? What is the regulatory response as we are finding these
adverse health effects that may result from exposure.

I think, unfortunately, for a variety of reasons, we have now
moved farther apart, and we are back throwing bombs at each
other. I think that is unfortunate. I am not sure there is a solution.
I would like to find one.

After World War II, there were two parallel events that occurred.
One was the biochemical revolution and the introduction of pes-
ticides into American agriculture. The other was the birth of the
'"boomer generation" and many of us in this room are Members of
that generation. We have traveled that road together and we are
now all children of the chemical age, for better or for worse. I think
that is the essence of the debate: for better or for worse.

There is no question that pesticides have changed the face of
American agriculture. There is no question that they have in-
creased yields, there is no question they have been good for the
consumer in many respects, good for the farmer in many respects.
There is a book about technology called "The God That Limps," and
there is no question as well that there has been a down side to this
introduction of chemicals into agriculture.

We now use some two billion pounds of pesticides every year in
this country. In California where I live we use 500 million pounds
of these poisons and they are poisons. That is about 20 pounds for
every man, woman, and child in my State. They have fouled the
rivers, the lakes, drinking water supplies. Over 1,000 drinking
water wells in California have been closed from DBCP contamina-
tion. An EPA survey of ground water found that some 15,000
drinking water wells have been contaminated with pesticides, more
than 9,000 at levels higher than EPA said were safe.

We are, I think, beginning to take some steps and I think the
chemical industry is to be complemented for taking some steps to
try to deal with the chemicals that leach and use them in a more
constructive manner so that we can grapple with this ground water
problem which is a very serious problem.

In discussing food, we focus a great deal on what is the exact
health risk? Is it zero? Is it 1, 10, 100?

Is it in avocados or apples or pears or peaches or milk or meat
or dairy products?

We focus too little on the generic question of what does it do to
the natural environment to put billions of pounds of these chemi-
cals every year onto the earth. Where do they go? Only about 1 per-
cent reach the target organism. That leaves 99 percent. Some of it
evaporates; some of it gets into the water.

Farmers are becoming more like chemical workers; they are
being exposed to the chemicals. We still do not know what the long-
term health effects are.

One new study of the boomer generation found that at least
there is a reason to believe that we male members of the boomer
generation are three times as likely to develop cancer, nontobacco-
related cancer, as were our grandparents.

Is that from toxic chemicals? Is that from pesticides? No one can
say with any certainty. They could not say 30 years ago with any
certainty, and I would imagine that 30 years from now science will
not tell us with certainty whether the increase in so many forms
of cancer is attributable to pesticides.

Ms. Brickey indicates that we should look at the wildlife. I think
that is correct. If you look at places like the Great Lakes where we
are seeing waterfowl and fish — male fish becoming female, her-
maphroditic; in the Everglades, alligators changing sexes, very low
birth rates, behavioral disorders, birth defects; the Everglades leop-
ard developing testicular atrophy — if it can do it to a leopard, I am
going to look at it and I am going to worry.

The policy response to pesticides in 1958 was the Delaney clause.
I am the lead counsel in two cases implementing the Delaney
clause. One v/as called Les v. Reilly. It is now finally decided in the
Ninth Circuit and had Delaney applied to pesticides. The other is
called California v. Browner. It seeks to implement the Les decision
across the board. I have been pleased that this administration, un-
like its predecessor, has taken the Delaney clause seriously. Over
the next several months the Agency will begin to actually act on
pesticides that violate Delaney.

Is Delaney perfect? No, I do not believe it is. It is not a panacea,
but it remains the appropriate policy response to toxic chemicals.
The policy of Delaney, of prevention, the policy of slowly but surely
reducing human exposure to pesticides that cause cancer and nerve
damage and reproductive harm and so many other ills is the proper
policy response.

For any new legislation, I think there are two goals. I almost feel
like this is health care. I do not care how we get there, but there
are two goals that the industry, the environmental groups, the
Congress, and the public, I think, should share. One is to reduce
the overall use of pesticides in agriculture over the coming years
from this 2 billion pounds. Other countries are doing it around the
world, and there is no reason we cannot.

And the other is to slowly phase out those chemicals that are the
worst actors, many of which were developed during World War II.
They have been on the market 50 years, the parathions, and the
like. There are a number of chemicals that there is simply no
longer any excuse to allow in our environment. If those two policy
objectives can be achieved, we will go a long way to finally finding
a solution to these problems.

Thank you.

Senator Daschle. Thank you very much, Mr. Meyerhoff. We ap-
preciate your insight and comments this morning — this afternoon.

Senator Daschle. Jay Vroom, the president of the National Agri-
cultural Chemicals Association, is next. Mr. Vroom, welcome.

STATEMENT OF JAY J. VROOM, PRESIDENT, NATIONAL
AGRICULTURAL CHEMICALS ASSOCIATION, WASHINGTON, DC.

Mr. Vroom. Thank you, Mr. Chairman. I too would like to com-
mend you for holding this hearing and for the keen interest that
we all know this subcommittee and the Full Committee on Agri-
culture and Forestry in the Senate has in the issues that are criti-
cal not only to the members of my organization that account for the

manufacture of nearly 100 percent of all the active ingredients
used to protect crops in American agriculture, but, indeed to our
customers, the American farmer, and our ultimate customers, the
American food consumers.

I too would like to speak from the heart as my friend, Mr. Meyer-
hofif, has just done in a very profound way. I would like to add a
little perspective to what he has just said. I agree with a great deal
if not all of what you just said, Al.

Mr. Meyerhoff. Write that down. Someone write that down.

Mr. Vroom. But I would like to add that in addition to the risks
which we must manage with regard to the use of my industry's
technologies in producing abundant and safe food and fiber, that
we ought to also be reminded of the benefits. From my perspective,
having been bom in the early 1950's on a livestock farm in Illinois,
I can tell you exactly what the use of technologies have meant to
the productivity of corn and soybean output on my home farm.

And I think that it is pretty evident if you look at macroeconomic
data available from USDA, that in my lifetime, over four decades,
American agriculture has more than doubled, perhaps nearly tri-
pled its total output. I think it has got even higher quality values
than a doubling or a tripling in those 40 years, and it is doing that
with 40 percent, maybe 50 percent less labor employed on the farm.

That means that people like myself and quite a few others that
are in this room who grew up on farms — do not work there any
more. I am not sure that I would like to go back to earning a living
the way my father did in the early and mid-1950's with not so tech-
nologically intense agriculture.

We do appreciate the chance to be here. We have likewise got
written testimony that we request be included in the hearing
record. We also have some detailed comments on the legislation
that Mr. Pryor and Mr. Lugar have cosponsored and introduced,
S. 1478, that we would also like to offer for the record.

The benefits of our industry's technologies and other technologies
that farmers use in concert with an ever-varying deployment of
crop protection technologies were exemplified by remarks that Mr.
de la Garza made at the beginning of the Domestic Operations and
Nutrition Subcommittee markup of Food Safety in the House yes-
terday.

At that hearing the Chairman pointed out that Americans are
the best fed consumers in the history of the world, spending the
least amount of disposable income per family for food, and he at-
tributed a lot of those advances to technology and I think he is
right.

EPA Administrator Browner apparently agrees with that state-
ment, in general. In June she told your Full Committee here that
this country enjoys one of the safest and most affordable food sup-
plies, and one of the most abundant in the world. I represent the
industry that provides some of those important technological tools
for ag production. We are proud of our contribution. We believe
that this system of regulation of our industry is sound. It is an im-
portant part of our business. It is a valued part of our business.
It provides predictability and continuity for the important and
long-term investments that are required to stay in this business.

Mr. Lugar has one of our member companies headquartered in
his home town. They just dedicated a new world headquarters and
research facihty. Hundreds of milHons of dollars are committed to
long-term research and development represented there and other
places around this country.

NACA, along with 250 members of the Food Chain Coalition sup-
ports S. 1478, and we think it represents substantial compromise
and progress. I think it is fair to say that all the major participants
agree that Delaney does need to be reformed and we look forward
to hearing more about your thoughts and the thoughts of the other
witnesses about how that might be attacked. It is especially impor-
tant because of the mis-information that we continue to see im-
posed upon the American consumer by supermarket journalism and
tabloid television. It is especially important that these policy deci-
sions, be based on sound science and not hearsay or exaggerated
claims.

In that regard we are deeply concerned about a lot of misleading
statements that are coming from the senior political policymakers
at EPA. In statements at the National Press Club and elsewhere
EPA leaders have declared that the current food safety laws toler-
ances are not health based. That statement and the implication
that tolerances are based on agricultural convenience are benefits
only to the registrant is patently untrue.

My industry is committed to reform and the process of develop-
ing new policy and new law that will make sense not only for our
business but also for our customers and American food consumers
and consumers around the world.

We are committed to working with you, Mr. Chairman. We look
forward to working with this committee and the other committees
of jurisdiction in the Congress that have a critical interest and are
working hard to try to advance progress.

It is a tough issue, one that we all believe passionately in and
we thank you for this opportunity to appear before you.

Senator Daschle. Thank you for your testimony and without ob-
jection all of the testimony that you have brought to the committee
will be made a part of the record at this time.

Senator Daschle. Dr. Philip Landrigan is, as I said, the chair-
man of the committee on Pesticides in the Diets of Infants and
Children for the National Research Council and we are pleased
that he could be with us. Welcome.

STATEMENT OF PHILIP J. LANDRIGAN, M.D., CHAIRMAN, COM-
MITTEE ON PESTICIDE IN THE DIETS OF INFANTS AND CHIL-
DREN, NATIONAL RESEARCH COUNCIL, NEW YORK, >nr

Dr. Landrigan. Thank you, Mr. Chairman. I am pleased to be
here and I applaud you on having called this hearing.

I am a pediatrician trained clinically in pediatrics. I spent 15
years as a commissioned officer in the U.S. Public Health Service.
I have been professor of pediatrics and professor of community
medicine at the Mt. Sinai School of Medicine in New York City
since 1985.

I had the privilege from 1988 to 1993 to chair the Committee on
Pesticides in the Diets of Infants and Children that was convened
by the National Academy of Sciences under a directive from your

committee. Our charge was to examine the current pesticide regu-
latory system in the United States and specifically to look at
whether this regulatory system provides adequate protection to
children.

The major conclusion that we reached is that the regulatory sys-
tem does not provide adequate protection to children. There are
several reasons why we believe that the system fails. I would like
to take a moment to enumerate those factors with you.

The first problem is that this current system fails to recognize
that children are fundamentally different from adults. They differ
from adults in two principal ways.

First of all — and this is the one that was more intuitively obvious
to all of us on the committee as we started our work — is the simple
fact that the children are not little adults. Children, and particu-
larly the very youngest children, are undergoing rapid growth and
development; organ systems are still not fully formed at birth. The
nervous system, for example, still has a long way to go at birth.
If you have ever tried to discuss philosophy with a 2-month-old, the
hardware and the software are not yet there; they are still being
formed. Because this development is an extraordinarily delicate
process, it is highly susceptible to disruption by any one of a num-
ber of factors including chemicals, including physical agents.

An even more important difference between adults and children
is the fact that the dietary exposures of people in different age
groups differ absolutely enormously from each other. For example,
a child under the age of 6 months consumes seven times as much
water, pound per pound of body weight per day, as does an adult.
These are vast differences and generally they tend to be several
times greater than the biological differences between adults and
children.

Unfortunately the pesticide regulatory system that has been in
place for so many years does not consider these differences at all.
It considers all Americans as though we were young adult males
consuming the diet that is typical of a fully formed member of the
species. In consequence of this regulatory oversight, little children
who concentrate on a small number of foods and eat relatively vast
quantities of those few foods can be quite seriously overexposed to
pesticide residues in the diet if any of those few foods happen to
be heavily contaminated. Our committee did spend several years
running computer scenarios that laid out the dimensions of this
problem. We showed quite clearly that potential for serious over-
exposure of children to pesticides exists.

I should emphasize — that the findings of our committee were
arrived at unanimously. We had a committee that differed substan-
tially in their scientific backgrounds, in their life experiences,
and in their political points of view. Yet after 5 years of working
together we reached unanimous conclusions. There was no dissent;
there was no minority report.

We had a lot to say in the committee report about tolerances. We
are very much concerned that the present procedure for setting
pesticide tolerances in foods does not adequately protect children.
Tolerances are set through a balancing process. Health concerns
enter into the judgment but also economic and agricultural factors
enter in.

One of the very striking documents that came into our hands as
we were proceeding through our work was a letter that was sent
to Senator Kennedy by Ms. Linda Fisher, then the Deputy Admin-
istrator of EPA, Hsting several hundred pesticides where the toler-
ances exceeded the so-called reference dose, the number that used
to be called the acceptable daily intake for pesticides.

The committee was really quite shocked by this document. We
were very much concerned that there were many pesticides allowed
to be present on foods in levels that are not safe. We believe that
that is a situation that needs to be remedied. We made it our very
explicit conclusion that the Government must have as its clear goal
in the setting of tolerances that the health of infants and children
be protected.

We made a series of technical recommendations. I will not bore
you with the details of them now, but they had to do with: First,
better collection of food consumption data; second, better testing of
pesticides for toxicity particularly better testing of toxic effects that
would result from early exposure. We made recommendations
about the need to consider the combined effects of pesticides that
have common mechanisms of action, something that is not consid-
ered by the EPA today.

I shall stop there. Mr. Chairman, I would like my full statement
entered for the record.

Senator Daschle. Without objection it will be made part of the
record and we thank you very much. Dr. Landrigan.

Senator Daschle. Dr. Stephen Ziller, the vice president for
Science and Technology of the Grocery Manufacturers of America.
Dr. Ziller, thank you for coming. Please proceed.

STATEMENT OF STEPHEN A. ZILLER, Ph.D., VICE PRESIDENT
FOR SCIENCE AND TECHNOLOGY, GROCERY MANUFACTUR-
ERS OF AMERICA, INC., WASHINGTON, DC.

Mr. Ziller. Thank you, Mr. Chairman. I have submitted a more
detailed statement which I would like to have put in the record.

Senator Daschle. Without objection, it will be made a part of the
record.

Mr. Ziller. I want to thank you and the Members of the sub-
committee for inviting me to speak,

I am the vice president for Science and Technology at the Gro-
cery Manufacturers of America. This group is an 85-year-old na-
tional trade association comprised of more than 130 manufacturers
and companies

Senator Daschle. Dr. Ziller, would you mind pulling the micro-
phone close to you? Thank you.

Mr. Ziller. GMA members employ over 2.5 million people and
our members produce more than 85 percent of the packaged food
sold at retail in the United States. For almost two decades GMA
has supported the concept of revising the statutory provisions gov-
erning Federal regulation of pesticides used in the production of
food. That support has, of course, been conditioned upon new legis-
lative provisions that would strike an appropriate balance between
preserving an abundant food supply and protecting against unsafe
pesticide residues.

My testimony today will deal with these several general prin-
ciples that GMA believes are essential to any successful legislative
approach to revise the current statutes relating to Federal regula-
tion of pesticide residues in foods. Due to a time constraint I will
briefly describe some of those today.

First, national uniformity. It is essential that any legislation es-
tablish a single national policy for the regulation of pesticides used
in food production. We cannot tolerate a system of 50 different pes-
ticide laws. Any legislation lacking national uniformity is not ac-
ceptable to GMA and its members.

Second, safety of pesticides. New legislation should require pes-
ticide tolerances to be established at a level that will adequately
protect the public health. We support the use of reasonable risk as-
sessment procedures to assure that there is a negligible risk. It is
inappropriate and scientifically unacceptable to establish detailed
rules for safety assessment in legislation because science changes
so quickly and the legislation simply cannot keep up with it.

Third, benefits of pesticides. Any new legislation must reflect the
fact that pesticides play a major role in the production of a safe
and wholesome food supply and thus provide substantial benefits
to the American public. Pesticides control disease and preserve an
adequate and affordable food supply.

Fourth, the food pipeline. The presence of pesticides in the food
chain occurs not at a single point in time but over many years. It
is possible to stop using a pesticide or to reduce pesticide use on
the farm at any particular point in time, but nothing can be done
to remove or alter the pesticide residues that exist from prior legiti-
mate use on food that has already entered the food pipeline.

Appropriate legislation must therefore reflect that food contain-
ing pesticide residues that were lawful at the time of use must re-
main lawful throughout the subsequent life of that food unless new
information demonstrates a serious health hazard.

Fifth, enforcement. Both EPA and FDA currently have extraor-
dinarily strong enforcement authority that is more than adequate
to implement any new pesticide legislation. New enforcement au-
thority for EPA and FDA will preclude industry support on legisla-
tion.

Citizen suits and whistleblower provisions are extraneous to pes-
ticide legislation and cannot be justified. Any legislation with en-
forcement provisions of these types will be vigorously opposed.

It is important to pare down pesticide legislation to the bare es-
sentials, if it is to be supported by the food industry.

The principles mentioned today and those included in the written
statement establish the GMA position on these matters. The legis-
lation introduced by Representative Lehman and Senators Pryor
and Lugar here today meet these general principles, and we sup-
port that legislation.

I would note that H.R. 1627 has the support of 222 Members of
Congress, and was marked up yesterday in the House Domestic
Operations and Nutrition Subcommittee of the House Agricultural
Committee.

The legislation recently introduced by the administration violates
virtually all of these principles, and we strongly oppose it.

Thank you.

Senator Daschle. Thank you, Dr. Ziller.

Our next witness is Ms. Juanita Duggan, the senior vice presi-
dent of Government Affairs for the National Food Processors Asso-
ciation.

Ms. Duggan, thank you for being here.

STATEMENT OF JUANITA DUGGAN, SENIOR VICE PRESIDENT,
GOVERNMENT AFFAIRS, NATIONAL FOOD PROCESSORS AS-
SOCIATION, WASHINGTON, DC.

Ms. Duggan. Thank you, Mr. Chairman.

NFPA is a food trade association with a science and technical
background, and we maintain three state-of-the-art food science
laboratories around the country.

Senator Daschle. I am not sure the microphone is picking you
up. You may just want to pull it a little bit closer to you.

Ms. Duggan. Is that better?

Senator Daschle. Yes, I think so.

Ms. Duggan. We represent many of the fruit and vegetable proc-
essors in the United States, and therefore we have a tremendous
interest in food safety procedures and pesticide regulatory stand-
ards at EPA.

We are very happy to be here today to talk about some of the
important pesticide policy decisions that are facing the EPA.

The food processing industry strongly supports the development
of effective alternatives to pesticides, but we would note that even
with ongoing efforts to reduce the pesticide use and to develop al-
ternatives to pesticides, pesticides will be necessary for the produc-
tion of an adequate, wholesome, and nutritious food supply for the
time being.

NFPA has long supported statutory changes to the Food, Drug,
and Cosmetic Act and to FIFRA to reform the Delaney clause to
establish a uniform standard for pesticide residues in both raw and
processed foods and to give EPA sufficient authority to take into
account best scientific information when making those tolerance
decisions.

We have been hopeful that this would be the Congress where we
could produce a piece of pesticide reform legislation. We are a bit
dismayed that we are here in the summer of the second session,
and we have made very little progress to date on moving a piece
of legislation. We are encouraged by the Ag Committee's interest
today, and hopefully we will be able to move forward as the House
subcommittee did yesterday.

The administration has recently released its own proposals, and
you heard from Dr. Ziller that the food industry has many concerns
about those proposals. I would like to discuss why NFPA supports
other bills, namely S. 1478 introduced by Mr. Pryor and Mr. Lugar.

We appreciate the fact that the administration recognizes that
the Delaney clause is outdated and must be reformed, but their bill
would restrict, rather than enhance, EPA's ability to apply the best
scientific in making tolerance decisions.

We also believe that the administration's bill goes far beyond
what is needed to reform the Delaney clause. It is a FIFRA reform
measure, an enforcement piece of legislation, that includes many
things that are not necessary to Delaney reform.

It would eliminate the consideration of benefits. It would revise
most major FIFRA procedures to reduce public participation rights
and scientific review requirements. It would authorize multiple ad-
ditional enforcement powers to both EPA and FDA, and it would
authorize citizen suits in a variety of contexts.

We do not believe there is any demonstrated need for such a
total overhaul of FIFRA.

The administration has argued that immediate legislative action
is needed to avoid the potential crisis that has been created by the
Ninth Circuit Court Decision that Mr. Meyerhoff referred to, the
Les V. Reilly decision that was handed down in 1992.

The administration has stated that unless immediate legislative
changes are made, the Agency will have no choice but to revoke tol-
erances for a large number of valuable pesticides with serious ad-
verse consequences for both agriculture and the food processing in-
dustry.

We maintain, however, that the Agency's hands are not tied bv
the Les v. Reilly decision. The potential devastating loss of agricul-
tural pesticides that are threatened by EPA are not necessarily a
result of the Les v. Reilly decision, but are instead the result of
EPA's concentration and coordination policies. The policies are an
EPA invention, they were never properly adopted as regulation,
and we believe they should be abandoned.

In September of 1992, NFPA filed a petition, along with several
other groups — some of them are represented at this table — in
which we urged EPA to rescind the concentration and coordination
policies and no longer require separate 409 tolerances for pesticides
and processed foods.

Basically we have asked them to follow the language and the in-
tent of the flow-through provision of the Food, Drug, and Cosmetic
Act, which would provide that a pesticide residue in a processed
food, when ready to eat — which is a key concept — is lawful, as long
as the residue is not greater than the tolerance for the raw com-
modity from which the processed food was made.

The petition demonstrates that there is no sound legal or public
policy basis for EPA to continue the concentration and coordination
policies, and we believe that EPA should not be permitted to per-
petrate these policies to create an artificial pesticide crisis in order
to get an unnecessary FIFRA bill.

Moreover, the Administration bill does not address several issues
that are of critical importance to us, one being national uniformity,
which you just heard about, and it does eliminate the consideration
of benefits, which we believe to be a key concept in any meaningful
reform of FIFRA.

In short, we strongly support S. 1478. We believe that it is the
best vehicle to pursue for pesticide reform in this Congress. It
would streamline the cancellation and suspension processes. It
would establish a consistent negligible standard for raw and proc-
essed foods, and it would assure appropriate consideration of bene-
fits and national uniformity for tolerances.

I would like to add that S. 1478 also contains specific provisions
which we strongly support that would require EPA to implement
the recommendations described within the recent National Acad-
emy of Sciences report on pesticides in the diets of infants and chil-

dren. This is the most complete response of any bill before the Con-
gress to the NAS recommendations. It simply directs the adminis-
trator of EPA to implement all of those recommendations. So we
are very strongly supportive of that.

Yesterday, the House subcommittee on — what is generally re-
ferred to as the Donut Subcommittee — Domestic Operations and
Nutrition marked up H.R. 1627, the Pryor-Lugar Companion bill,
and we look forward to similar action here on the Senate side.

That concludes my statement. I have a longer statement that I
would like for you to include in the record.

Senator Daschle. Thank you. Without objection, it will be made
part of the record.

Ms. DUGGAN. Thank you.

Senator Daschle. Mr. Jim Bender is a farmer and author of the
book, "Future Harvest" He is from Weeping Water, NE.

How big is Weeping Water, Mr. Bender?

Mr. Bender. 1,000 people.

Senator Daschle. 1,000.

Senator Pryor. At least it is not Whitewater.

[Laughter.]

Senator Daschle. Whitewater is weeping water.

[Laughter.]

Senator Daschle. Please proceed. With that editorial comment,
we will take your testimony.

STATEMENT OF JIM BENDER, FARMER AND AUTHOR OF THE
BOOK "FUTURE HARVEST," WEEPING WATER, NE

Mr. Bender. Mr. Chairman, and Members of the subcommittee,
I appreciate the opportunity to participate in this hearing this
afternoon.

A central issue for pesticide policy concerns what American agri-
culture would be like with only minim.al reliance upon chemical
pesticides. There are several ways to pursue this subject.

An obvious one would be to study contemporary farms in which
pesticides have been minimized or eliminated. Especially useful
would be farms that are otherwise typical. By "typical," I mean
farms that have developed with their fair share of agronomic chal-
lenges, do not rely upon inputs unavailable to agriculture in gen-
eral, and have not received grants or other special funding.

Our farm comes to mind. It has been free of pesticides on all the
land since 1980 and certified organic since 1990. It is a four-gen-
eration family farm, 642 acres, located between Lincoln and Omaha
at the very western edge of the nonirrigated Corn Belt, which re-
sults in moisture extremes.

Virtually all of the farm has been designated as potentially high-
ly erodible by the Soil Conservation Service. The topsoil on many
of the hillsides of the farm is thin as a result of profound soil ero-
sion during the first decades of this century.

How does this farm perform? In many ways, it is highly produc-
tive and conserving of resources. It competes with our chemical-
based neighbors in yields. It is exceptionally resilient in years with
difficult weather or economic conditions.

We receive visitors and agricultural researchers each year, who
are complimentary about weed control. In addition, aggressive,
multifaceted soil conservation program coincides well with the pes-
ticide-free cropping.

It provided employment opportunities for local youth.

And finally while the farm has enjoyed special organic markets
the last 2 years, prior to that time, mere conventional agricultural
markets paid for land, large modem machinery, buildings, and
other infrastructure.

The success of farms such as ours gives rise to a question: If
these farms effectively address so many problems and offer other
advantages, why, then, do our neighbors continue to farm in ways
heavily reliant upon chemical pesticides?

That is a question with no easy answer. A starting point, how-
ever, is the ways that Federal agricultural policy influences agri-
cultural practice. There are many examples.

Policy penalizes crop rotations that are essential to low and no-
pesticide farming. It generally does not orient research to support
this kind of farming. Federal policy on highly erodible farmland
places high priority on pesticide-based cropping practices. Policy
contributes to overly optimistic views of pesticide risk. Current
policies permit agricultural benefits to override health and safety
concerns.

These things and others influence agricultural practice. They
also begin to explain why farms such as ours are isolated, with so
little influence.

In conclusion, there are currently low and no-pesticide agricul-
tural systems creating solutions to basic agricultural problems.
Their effectiveness will continue to be limited until Congress re-
moves existing obstacles.

Thank you.

Senator Daschle. Thank you, Mr. Bender.

Our final witness is the president of the Pennsylvania Farm Bu-
reau. He is Mr. Keith Eckel from Clarks Summit, PA.

Welcome, Mr. Eckel.

STATEMENT OF KEITH W. ECKEL, FARMER AND PRESIDENT
OF THE PENNSYLVANIA FARM BUREAU FEDERATION,
CLARKS SUMMIT, PA

Mr. Eckel. Thank you, Senator, Mr. Chairman — Senators; my
name is Keith Eckel. I am president of the Pennsylvania Farm Bu-
reau, testifying on behalf of the American Farm Bureau, and I am
a farmer involved in vegetable and grain production in Lacka-
wanna County in Clarks Summit, PA, and we use a variety of tech-
nologies in our production, and we absolutely have been involved
in reductions of pesticides, as have most farmers been, in the oper-
ations of their businesses because of the economic incentives when
that is feasible.

Mr. Meyerhoff indicated that there had not been a lot of change
in the debate. There has been some change in agriculture.

Part of the written testimony that I would ask to be made part
of the record today, as well as the testimony that we would submit
on behalf of the Minor Crop Farmer Alliance — and we would ask
that you would accept that.

Senator Daschle. Without objection, it will be made part of the
record.

Mr. Eckel. One of the changes is, since 1976, in the written tes-
timony that we provide is that pesticide use has declined in real
pounds from 1976 to 1993. So, perception is not reality, and uses
have declined.

There is another occurrence that has occurred, and that is that
the cost, as a basis of income for purchasing food, has declined. In
fact, in the last 10 years, the average consumer has declined from
expending 16 percent of his disposable income for food to less than
11 percent.

The National Health Discussion was mentioned in the testimony
today. I would point out to you that we are studying a "national
health crisis," in quotes, because costs in the last 8 years have es-
calated from 9 to 14 percent. If it was not for agriculture's in-
creased productivity and lower costs, especially for low-income
American consumers, the health care crisis would be much worse.

So you readily recognize that I am not an agricultural apologist.
However, I am an advocate. Also, I am proud to be part of an in-
dustry that has contributed as much to this country and its con-
sumers as we have. We absolutely cannot continue to take that for
granted.

In my own operation, we have reduced pesticides with integrated
pest management. With new management techniques, with a use
of a variety of pesticides, and sometimes there nonuse, it requires
intensified knowledge, as I am sure Mr. Bender would testify to,
as we recognize pests, as we determine the thresholds for the use
of insecticides, and we use a broadbased supply of various products
to control the pests that we are dealing with.

One of my strong concerns in the proposals that we are looking
at is that in nature they seem to be punitive rather than friendly,
punitive in the sense that who would want to be an applicator, a
commercial applicator of pesticides, if the first offense is going to
be considered criminal in nature with penalties up to $25,000 for
use? Who is going to be encouraged to enter into that field and
bring more technology, rather than less, to the application on our
farms?

And so that whole section has concern for us as far as the puni-
tiveness of it. Civil actions indicating that perhaps the EPA and
the Federal Government is unable to enforce their own regulations
would indicate to me that what we are attempting to encourage is
people without technical knowledge coming and looking at our own
farms and determining whether or not those practices are proper
or right, filing complaints, and causing us to expend untold dollars
in legal expenses as we defend ourselves in proper actions.

Minor-use pesticides, — let me give you just one economical exam-
ple— and this is what puzzles me with food safety.

I produce fresh market tomatoes in my own operation, and we
use herbicides in that production. One of the herbicides that we use
for nutgrass control is Tillam. One of the problems with Tillam is
that it does not have any control for a new weed problem that we
have called nightshade.

There is a product on the market today, legal for most major
crops, also legal incidentally for string beans, legal for use in Can-

ada on tomatoes that are shipped into this country and produced,
called Dual. The cost of that product — and that controls
nightshade — the cost of that product is $15-an-acre in comparison
to $40-an-acre for the Tillam.

Because we have created the onerous system for re-registering
pesticides and the uncertainty in our system for whether or not
they are going to be removed — and under the new system that is
proposed by the administration, we would be able to remove pes-
ticides without even the proper due process of the registrant — there
is absolutely no encouragement to add the minor-use of tomatoes
for Dual. So one singular item costs me $25-per-acre, but adds ad-
ditional cost to every consumer in this country.

I see the red light is on, yet, I want to speak; if you will indulge
me one moment to the issue of health.

The first step to good health in this country or around the world
is proper nutrition. To ignore the benefits that are afforded to us
by our technology today is to bury our heads in the sand and not
recognize the immense benefit to the low-income people in this Na-
tion and those in developing Nations around the world who partake
of the bounty of American farmers' production as a result of our
technology.

Gentlemen, we have a major responsibility here, not to reinvent
the wheel, but to create a system that encourages the development
of new and safe technologies that provide an adequate and reason-
able food supply for this Nation and the rest of the world and also
maintain our environmental sensitivity.

We, today, are producing on the same number of cultivated acres
that we were in 1900, not in small part due to the fact that tech-
nology, part of which is pesticides, has allowed us to enhance that
and improve the wildlife habitat instead of destroy it.

Gentlemen, I appreciate the opportunity to testify before the
committee. I look forward to your questions. I am confident that
you will work together to give us a bill that will maintain the con-
fidence of American farmers as they face a very uncertain future.

Senator Daschle. Thank you, Mr. Eckel, for your comments.

We appreciate the testimony and the contribution made by all of
our witnesses this afternoon.

We like to encourage a good healthy discussion at these hearings,
and that is why we have set it up as we have. We appreciated very
much your opening remarks, but we would like very much now to
enter into a good discussion about a number of the issues that have
already been raised in testimony and in our opening remarks.

Let me again invite Senator Pryor to make any comments. He
had indicated that he perhaps would wait until the end of testi-
mony before he said anything. If he has some remarks to make at
this time, I would invite him to do so.

Senator Pryor. Yes, please. I would like to start our discussion
and then maybe I could enter into it a little later.

Senator Daschle. OK

Senator Pryor. It is not that I am afraid of these people or any-
thing.

[Laughter.]

Senator Pryor. I have enjoyed hearing the various statements,
and I think it is very instructive to listen a Httle further.

Senator Pryor. Thank you, Mr. Chairman.

Senator Daschle. Thank you, Senator Pryor.

Let me just begin. I have a lot of questions, and I would encour-
age all of our Colleagues to interject here.

Let us go back to the Delaney clause for just a minute. I am not
sure I understand the collective perspective of this group. I would
be interested if we could, maybe beginning with Mr. Meyerhoflf,
talk about whether it is the view of this panel that EPA specifically
needs more regulatory authority in order to regulate the Delaney
clause, given the rulings, especially the Les v. Reilly ruling, or is
it your view that EPA has the ability to do it unilaterally without
additional authorization?

Mr. Meyerhoff?

Mr. Meyerhoff. Well, Jay — Jay Vroom — indicated at the begin-
ning of his testimony that he agreed with almost everything I said,
so

Mr. Vroom. Almost.

Mr. Meyerhoff [continuingl. I think I could speak for both of us,
perhaps.

Mr. Vroom. Almost.

[Laughter.]

Mr. Meyerhoff. The Delaney clause, the essential premise of
the Delaney clause, is that of a substance induces cancer in man
or animal, its presence in processed foods is not permitted. That
was because of an amendment in 1958 dealing with processed
foods.

The conflict that the NAS pointed to in its 1987 report on the
Delaney clause is that we have two fundamentally inconsistent
standards between processed foods and raw commodities.

Section 408, which regulates raw commodities, is, as Dr.
Landrigan indicated, a cost-benefit standard.

Right now, I think the administration — we have had numerous
meetings, the White House and at EPA, about how Delaney will be
implemented. Carol Browner, at the beginning of this administra-
tion, stated for the public record that the administration supported
changes in the Delaney clause, but only if those changes would im-
prove protection of public health.

If no changes were forthcoming, however, the administration in-
dicated its intention to obey the law as written. That is what I be-
lieve they are now about to do, and I believe that is long overdue.

They have not identified 35 or more pesticides used on roughly
100 crops where their current data indicates that the chemicals in
question, chemicals like Alachlor and Captan and DDVP, the
EDBC—EBDC—EB— ethylene diborochloride

[Laughter.]

Mr. Meyerhoff [continuing]. Are violative of Delaney.

Senator Daschle. But I guess what I am asking — and you are

giving a good answer — but just to

Mr. Meyerhoff. You want to know whether or not

Senator Daschle. Well, is it necessary, or is it desirable?

Mr. Meyerhoff. Delaney itself?

Senator Daschle. No, no. Is additional clarification in law hav-
ing to do with the Delaney clause a requirement, or is it simply de-
sirable?

Mr. Meyerhoff. Jay and I may disagree on this one.

The current law — we are quite content with the current law for
processed foods. Delaney is the most health-protective statute
adopted anywhere in the world.

Senator Daschle. But does EPA have the ability to respond with
some flexibility to the Delaney clause, given current interpretation?

Mr. Meyerhoff. In our view, after the Ninth Circuit Decision in
Les V. Reilly, they do not. In fact, that was the unequivocal holding
of the court.

The administration and EPA at the time asserted that they had
the right to find a de minimis risk exception to Delaney. That was
rejected by a court made up of three Judges, somewhat like this de-
bate— one Judge from the Eisenhower administration, one Judge
from the Reagan administration, and one Judge from the Carter
administration.

They reached agreement that Delaney was absolute and prohib-
ited pesticides that induce cancer and that concentrate from being
present in processed foods. Absent legislative change, EPA now
have to obey that law as written.

Senator Daschle. But you say in spite of that ruling you would
not be opposed to keeping the Delaney clause just as it is now au-
thorized?

Mr. Meyerhoff. That is correct. We do not believe that Delaney
is an absolute panacea. It does not deal with a variety of other end
points like nerve damage and reproductive failure, and it particu-
larly does not deal with the cost-benefit standard that is in 408,
and we would and do support legislation that would replace
Delaney with another approach, the one that I talked about in my
testimony. If not, we are quite willing to work together with the
administration to ensure they obey the law.

Senator Daschle. Mr. Vroom?

Mr. Vroom. Well, again, I think we agree that there are two an-
swers.

We might disagree with regard to the detail of what those two
answers or alternatives would be, and as we see it, the EPA has
ignored both statutory as well as regulatory fundamentals in tak-
ing it to the point where they have taken the execution of the strict
interpretation of Delaney in the Les v. Reilly case. Also, in my writ-
ten testimony there are six major points enumerated and identified
in great detail.

I think one of the most important points — is the "coordination
policy" with regard to 408 and 409 tolerances and the intensive sci-
entific knowledge about these particular compounds and the dozens
of other pesticides that EPA has also identified on a potential
Delaney target list beyond the seven in the Les v. Reilly case. They
are ignoring the scientific evidence of what fits the definition of "in-
duces cancer" as defined explicitly in the Federal Food, Drug, and
Cosmetic Act as it currently is on the books.

They ignore the differences between human species and labora-
tory animal species. When tumors occur in certain laboratory spe-

cies, organs that have no parallel to human species, then there
ought to be some kind of accepted scientific flexibility to make an
interpretation about what induces cancer in the translation to hu-
mans.

Those factors have been totally ignored by the Agency, and we
think they are incorrect; in some specific cases, we believe they are
illegal.

Given the strict interpretation of Delaney, based on the way the
Agency has indicated it is heading so far, we believe that the Con-
gress will be in a position to have to act in order to avert the so-
called train wreck.

On the other hand, we believe that the Agency does possess the
flexibilities within the law to take a different track, and we believe
that they may have the opportunity to consider those options in the
very near future.

Ms. DuGGAN. Senator Daschle?

Senator Daschle. Ms. Duggan?

Ms. Duggan. These are the issues that are found within the
NFPA petition. We are trying to take a step back in the wake of
the Les v. Reilly decision and look at the statute from a de novo
perspective, and our viewpoint is that Congress never really in-
tended for pesticide residues in processed foods to be treated as
food additives in the first place. EPA sort of backed into this policy
over the course of about 20 years by trying to interpret a de
minimis policy out of Delaney which the court has now said they
cannot do. They backed into this by developing these two policies,
what is referred to as the concentration and the coordination poli-
cies.

And the issue of whether or not pesticide residues concentrate in
processed foods above the raw product tolerances is a very con-
troversial one.

Yet, we do not believe that, number one, there is a whole lot of
evidence that they do concentrate above the raw product tolerance,
and moreover that EPA should be looking at that on a ready-to-eat
basis, which they do not do right now. EPA makes these deter-
minations on commodities such as flour and tomato paste, and peo-
ple do not sit down to meals of tomato paste and flour,

Mr. Meyerhoff. I do, actually.

Ms. Duggan. You do?

Mr. Meyerhoff. It is quite a good snack.

[Laughter.]

Ms. Duggan. OK

Mr. Meyerhoff. It is just very nutritious.

Ms. Duggan. It sounds great. I will have dinner with you some-
time.

[Laughter.]

Ms. Duggan. But they have the flexibility to make changes like
that in the way they decide if they need a 409 tolerance in the first
place. Not once have they set a 409 tolerance, does the Delaney
clause apply or not, but how do you get into 409? What policies
draw you into 409 in the first place?

The NFPA petition sets out a legal pathway under the current
statute that would allow them to avoid the most devastating poten-
tial that would be the result of the Les v. Reilly decision.

That being said, the NFPA also believes that the only way out
of this paradox that the NAS described years ago is to reform the
law: the Delaney clause is outmoded; it is antiquated. Approving
the NFPA petition and establishing those regulatory policies would
be a partial fix. You have to have a change in the law to dispense
with this whole notion that zero risk a possibility in today's world.
Science has moved way beyond that.

So we have a strong interest in trying to develop a policy in the
law, in a pesticide reform law, that would give us negligible risk
authority and that would avoid creating arbitrary and capricious
standards that are very similar to what the Delaney clause was in
the first place.

We are very concerned that if we do something very restrictive
and arbitrary, we will find ourselves in the next 10 years with a
new Delaney clause, and that is why we strongly support the neg-
ligible risk policies that are in S. 1478 as opposed to the more pre-
scriptive approaches that freeze today's science into the statute. We
are very, very concerned about that.

Senator Daschle. There appears to be unanimity that modifying
the Delaney clause is either something we could support or at least
not oppose. I think that is — is that an accurate statement with ev-
erybody at the table?

Mr. Eckel. Senator, that is correct.

Senator Daschle. Well, let us talk a little bit, then, about what
we define as negligible risk. As I understand it, there appears to
be sort of a consensus that we can achieve a negligible risk stand-
ard for pesticide residues, even for carcinogens, that regulators and
environmentalists and processors and farmers all are somewhat in
concert with regard to their confidence about determining that
standard. Is that accurate?

Ms. DUGGAN. I think there is a

Dr. Landrigan. Senator, could I speak to that?

Senator Daschle. Let us do it all at once.

[Laughter.]

Dr. Landrigan. Four-part harmony.

Senator Daschle. Go ahead.

Dr. Landrigan. I think that in theory it might be possible, but
we have to recognize that there are some profound practical limita-
tions.

Our committee from the NAS was silent on the issue of Delaney
versus some alternative to Delaney. It was not within our charge
to express an opinion on that very important issue, and we did not.

What we did observe — and there is simply no question about
this — is that there are great gaps in our knowledge today about the
hazards of pesticides to the American public. These gaps are espe-
cially great when it comes to understanding the effects of pesticides
on cnildren.

One sort of study that has been done for almost no pesticides is
a study in which your experimental animals of some particular spe-
cies, like rats, would be exposed in early life to a pesticide and then

allowed to live for their normal life span, which is several years,
depending on the species. The end point would be to see what hap-
pened to the animals at the end of their lives.

This is a situation that is totally analogous to exposing an infant
to a pesticide and then waiting 75 years to observe effects until the
infant grows into old age.

In the absence of that sort of testing — and it has not been done,
except for very few chemicals — we are much flying blind when we
talk about developing very sophisticated paradigms for risk assess-
ment. Sure, we can come up with lovely mathematics and lay out
beautiful equations. EPA is skilled at that.

However, the problem is that if the data that are going into those
equations are faulty and if many, many datapoints are simply ab-
sent, then the exercise is a gamble. That is something we must
bear in mind as we talk about this subject.

Sure, science has advanced, as several of the witnesses around
this table have said. We know more about toxic effects than we did
in the past. Yet, at the same time, even as we know more, we know
there is more that we do not know; 30 or 40 years ago, most of the
concern about pesticides concerned cancer. Cancer, of course, is the
only endpoint that is mentioned in Delaney.

Today we know from laboratory testing that chemicals can cause
chronic damage to the nervous system. There is no proof, but there
certainly is a lot of suspicion that some cases of chronic neurologic
diseases like Parkinson's disease might, in some cases, be caused
by chemical exposures. We will probably have better information on
that in a few years.

Reproductive problems have been hinted at. The evidence has
been elusive because the experiments are hard to do. Yet, anybody
who says that there is no risk of reproducing damage from pes-
ticides is being rash, in my opinion.

Senator Daschle. How do we define — I mean — I think we can go
on at some length about the hazards of negligible risk is, we fail
to appreciate that negligible risk is still risk. The question is, "How
do we define 'negligible risk', and how could we achieve a consen-
sus on that definition?"

I sense that there is a belief that a consensus may be possible,
but I am not sure that I am satisfied that there is a consensus even
at this table. So if there is not a consensus at this table, how would
there be a consensus outside the room?

Carolyn?

Ms. Brickey, I think this is a very difficult issue, Mr. Chairman,
and you have, as usual, come to the heart of the problem.

I think that there is a great deal of concern on the part of the
organizations that I work with about the use of negligible risk as
confronted through the process of risk assessment. There are a lot
of unknowns about some of these chemicals, and we do have a lot
of years for these chronic health effects to take effect before we
know how serious they are.

I think before any kind of system like that could be acceptable,
there would have to be some severe limitations and safeguards
built into it.

The regulatory experience at EPA has also not been as positive
as some of us in this room would like it to have been. EPA has
been moving very slowly in looking at these old chemicals.

As you know, this committee enacted legislation in 1988 telling
EPA to reexamine hundreds of old chemicals by 1997.

Mr. Chairman, EPA is not going to meet this deadline. EPA will
tell you that. There are lots of problems, including resources, that
have slowed the progress down.

On the other hand, there are a lot of really serious concerns
about how you could possibly replace the Delaney clause as it ap-
plies to processed food and build enough safeguards in to protect
people from these other health effects. It is very difficult.

Senator Daschle. Well, somebody come forth with their defini-
tion. Let us work on a definition here.

Mr. Vroom. Mr. Chairman?

Senator Daschle. Yes, Mr. Vroom.

Mr. Vroom, We have referenced the National Academy reports
twice here — one, Dr. Landrigan's report on infants and children
and also the Delaney paradox report of the late 1980's.

Also in 1983 the Academy issued a report at the request of Con-
gress where they focused on the question of risk assessment in gen-
eral, and that has become a bit of a Bible in terms of risk assess-
ment reference. I think an important point to lift out of that for
the benefit of this discussion is that they pointed out in that report,
as I recall, that there should be a separation between risk assess-
ment and risk management.

Now risk assessment is something that Dr. Landrigan and his
Colleagues in the scientific community, from a variety of different
scientific disciplines, are always perfecting and attempting to ad-
vance every day in the laboratory and in debate, healthy debate,
amongst themselves, and it is something that I doubt that those of
us in the lay world really can fully understand or comprehend on
a day-to-day basis.

However, risk management is something that Congress and the
EPA implement and that Congress now has an opportunity, with
the potential of Delaney reform, not only for the benefit of agri-
culture but many other industries as well, to take a hard look at.

I would suggest that the underlying carcinogenic threshold is one
in a million — that is what the Delaney paradox report referenced.

I think all of us, at least on my side of the issue, would believe
that it would be incorrect to write "one in a million" into the Fed-
eral statute, because risk assessment is changing all the time, and
the use of that particular mathematical equation approach could be
vastly different in 5 to 10 years from now than it is today. It could
be report language and is currently the reference threshold that
EPA uses in establishing tolerances not applied to 409 processed
food.

Senator Daschle. Mr. Bender? Let me ask Mr. Bender for a com-
ment.

Mr. Bender. Thank you, Mr. Chairman. Before we finalize our
definition, would you accept one more criticism?

Senator Daschle. Absolutely.

Mr. Bender. Thank you. We have been focusing on the problem
of measuring risk, and that is a very serious problem associated
with this mode of risk assessment.

On the other hand, I think another is that the negligible risk
standard focuses only on probability of risk. When we think about
risk assessment, there are other dimensions, such as, for example,
whether it is equitably incurred, voluntarily incurred, how dev-
astating the risk would be if it were incurred. This focuses on one
sole aspect of the problem of risk.

Senator Daschle. Good point. Dr. Meyerhoff?

Mr. Meyerhoff. Just, Mister. I do not think this is a legal defi-
nition. A policy or ethical definition, to me, is an involuntary and
unnecessary exposure to a toxic chemical, and that if you can,
through an informed public policy, eliminate or reduce that expo-
sure wherever you can, you should do so.

And I think the example I would point to — I was just sitting here
thinking about it — one of the great success stories, in my opinion,
in environmental law and in public health over the last 20 years
has been lead. We have not won that battle, quite clearly. As the
report that was released this week indicated, lead levels in human
blood are down dramatically, and that is because the Congress and
the Government and the courts, in enforcing those laws, have
taken steps to eliminate lead in gasoline and a lot of other expo-
sures to lead.

Now we still have a lot of problems, particularly in the inner
city, with lead. We have dealt with at least the initial problem of
lead poisoning in the society — and Dr. Landrigan is one of the
world's experts on lead — ^by reducing those kinds of exposures.

And I think as he was also indicting, we cannot simply focus on
cancer. Cancer is a very serious problem. One out eight women in
this country will develop breast cancer in her lifetime. It is some-
thing we have to look at hard, why that is.

Neurotoxicity from these chemicals and other adverse effects are
perhaps of more importance. Look at what is happening to the nat-
ural environment. These are chemicals that are a problem beyond
how much is in food. We have been debating for 30 years which
number should we put on this food, this chemical, that food, that
chemical.

The reality of life is, we are exposed to a multiplicity of chemi-
cals. There are over 300 active ingredients alone of pesticides.
There are some 1200 poorly examined inert ingredients. I think it
is a fool's errand in a long-term policy to simply try to say what
precise risk for each one of these substances is, irrespective of what
their combination is, in every food, set those numbers, and then
walk away like we have solved the problem. We have not.

Ms. DuGGAN. If I could make a comment?

Senator Daschle. Yes, Ms. Duggan?

Ms. Duggan. What Mr. Meyerhoff brings up here is specifically
one of the reasons why the food industry was very supportive of the
recommendations in the NAS study for infants and children, be-
cause we strongly believe that the data gaps are very wide in the
way that the Government is able to calculate exposure. There are
manv, many things we do not know, and we need to direct EPA to
fill those data gaps, so that exposure assumptions can be based on

5n-T 01 n - oc, - o

actual exposure as opposed to these wild guesses that are overly
conservative that torque the picture of risk sometimes by many or-
ders of magnitude.

The more information we have, the better the risk assessment is
going to be. It is going to be very expensive to collect the kind of
data that is recommended by the NAS. However, this debate is
never going to go away until we do so.

NFPA has been maintaining for many, many years one of the
largest pesticide residue databases in tne country, possibly even
the world, because we want to know what the picture is of the ac-
tual residues that are out in the marketplace in the products that
our members produce.

And our data is entirely consistent with FDA's data. It is entirely
consistent with the State of California's data, which also does an
extensive amount of testing in the marketplace, and we have
found, you know, 98 percent of the food out there has no residues,
no detectable residues whatsoever, and when you do have detects,
they are so far below tolerance that they are irrelevant.

Mr. Meyerhoff. What was the source of the 98 percent — I am
just curious — ^from California?

Ms. DuGGAN. That is the NFPA database. It may not be the spe-
cific number. I can provide that for the committee. Yet, it is very,
very consistent across the board — the NFPA, the FDA, and Califor-
nia— and it is in the high 90's where there are no detects.

Mr. Meyerhoff. No residues at all?

Ms. DuGGAN. No detects, no detects.

Mr. Meyerhoff. I believe — I think the data is closer to 50 per-
cent.

Ms. DuGGAN. Multiple — no, no, no.

Mr. Meyerhoff. The data I am familiar with.

Ms. DuGGAN. No. It is way up in the high 90's.

Senator Daschle. Well, let us submit that for the record.

Mr. Meyerhoff. That would surprise me.

Senator Daschle. You think it is closer to 50?

Mr. Meyerhoff. Every market basket survey I am aware of —
FDA and CDFA's market basket data of where they found resi-
dues— has been 40, 50 percent. So the fact that it would be more
than 90 percent with no residue at all would greatly surprise me.

Ms. DuGGAN. Are you talking about detects or the level of detect?

Mr. Meyerhoff. No, you said — I believe you said— I believe the
witness said that 90 percent or more of the food had no detectable
residues of pesticides.

Ms. DUGGAN. Yes, that is our information, and I will be happy
to provide that for the record. The FDA, NFPA, and the State of
California databases are all perfectly consistent, within a few
points of each other. We are not going to

Mr. Vroom. Could that have been residues above tolerance? Is
that what you

Senator Daschle. You mean illegal residues.

Ms. DuGGAN. Yes, illegal residues.

Mr. Vroom. That is a fundamentally different-

Senator Daschle. Aha! We are making progress.
I know that Senator Pryor has another engagement that he
needs to be getting on to.

Senator Pryor. Thank you, Mr. Chairman.

First, I want to say, Mr. Chairman, I did not want to come to
this meeting this afternoon. I have been to too many meetings, as
has Senator Daschle, in the last 15 years at this table in this room.
When we left, there was blood all over the table and all over the
floor, and everyone left mad, and we did not speak again for an-
other 2 or 3 years.

[Laughter.]

Senator Pryor. And the media all wrote about the white hats
and the black hats. They characterized various parties and groups
in that way.

Now I felt it to be very unfair. Sometime back when I was asked
to be a part of attempting to move out into the middle some way
some legislation and to try to find a solution to the Delaney
clause — and I think most of our people here seem to think that the
Delaney clause needs some attention one way or the other — I was
very reticent to do it.

However, I want to say this to you, Mr. Chairman, I think that
this has been one of the more constructive meetings that I have
been to in a long time. It is not one of those typical formal meet-
ings when the Senators and the politicians get up there and talk
a long time. I think it has been an exchange. I think we have just
seen a situation here were we are looking at definitions and char-
acterizations, and at least we are coming to terms with some of the
terminology. I think that, in itself, is good.

Finally, I would like to say that I think that this committee has
attempted and is attempting — I know that Senator Lugar and my-
self are — we are attempting to find some solutions to the problems
that we face, not based on political rhetoric, but based on scientific
evidence, trying to find something based on fact. That is what we
are attempting.

We are not attempting to take the food chain, the greatest food
chain that civilization has ever known, and to contaminate it. We
are not doing that. We want to keep it the best and the cleanest
and the safest.

Yet, we do think that we have based our proposal on what we
thought, Dr. Landrigan, was many of the recommendations by the
National Academy of Sciences and the studies that you have com-
pleted and that we rely on. This is kind of where we are going
from.

Also, I just wanted you to know, as our participants, kind of
where Senator Lugar and I are coming from. This meeting, I think,
has been extremely helpful to me. We ought to do it again some-
time.

[Laughter.]

Senator Pryor. Really, I mean, I think we have made some real
progress because of your leadership in designing the way this was
augmented, and I very much appreciate it.

Senator Daschle. Thank you, Senator Pryor.

Senator Pryor. Thank you.

Senator Daschle. I want to move on to other issues, but before
we do, I am still not quite satisfied we are there in terms of maxi-

mizing our advantages in having you all with us this afternoon, to
give us your guidance on defining that negligible risk standard.

I mean, I think we are so close, and yet we are not quite there,
and I just want to nail that down to the extent that I can prior to
moving on.

So — yes, Mr. Vroom?

Mr. Vroom. One perhaps most important fundamental about
that computation is — and I think this is widely accepted in the sci-
entific community and elsewhere — is that risk is a function of tox-
icity times exposure.

Now Mr. Meyerhofif referred to the analogy of lead and the
progress that has been made in minimizing exposure. OK, how
does the toxicity of lead and the exposure of lead through phasing
out of lead-based or lead content in automobile fuel or lead-based
paints that children inadvertently ingested — how does that com-
pare with the risk times — the exposure times toxicity of very min-
uscule and many times nonexistent residues of active ingredient
pesticides in our food?

We need to put those kinds of things in the broad perspective,
and I think we also all agree that we need to have more uniformity
in terms of the standard between raw and processed food, that
those dual standards are very anachronistic.

They are putting an unfair disadvantage on our farmers and the
food sector in particular, because our dependence in the American
diet on fresh fruits and vegetables has grown substantially since
1958 when Congressman Delaney introduced this clause. We had
a much greater dependence on processed food in our diets at that
time. Now we have much greater availability of fresh fruits and
vegetables, thanks in large part to widespread refrigeration abili-
ties to preserve and bring those products right into our homes and
into our kitchens than we had 35 years ago.

All of those are very important factors. But the real basics are:
Risk equals toxicity times exposure. All those are important vari-
ables that we can work on, but we need a new standard from Con-
gress, and we need it sooner rather than later for the benefit not
only of agriculture, but a lot of other industries that are going to
be troubled by the Delaney clause.

And I suspect that NRDC has plans to litigate the Delaney
clause against other important exposure factors, and perhaps that
is not widely known, but it is not just a pesticide issue.

Senator Daschle. So there is no disagreement with the formula:
Risk equals toxicity times exposure?

Mr. Meyerhoff. No, I think there is disagreement. I mean, our
view and the view that is reflected by the Waxman legislation in
the House is that the fundamental goal of any pesticide reform
should be to prevent unnecessary exposure to categories of particu-
larly hazardous chemicals, and those are the probable human car-
cinogens, the nerve toxins, reproductive toxins.

Senator Daschle. But why? That is not in conflict with what Mr.
Vroom said, is it?

Mr. Meyerhoff. Well, maybe it is not. If it is not, we have legis-
lation language we would be glad to sit down and share with him
after this hearing.

Senator Daschle. Dr. Landrigan?

Dr. Landrigan. This distinction between risk assessment and
risk management that Mr. Vroom mentioned was the subject of a
1983 report from the National Academy of Sciences. I was a mem-
ber of the Oversight Board at the NAS that oversaw the production
of that report, so I am quite famihar with it. In a nutshell, risk as-
sessment is science. It involves doing studies on exposed people; it
involves doing studies on exposed animals; and calculating how
many excess cancers or how many excess birth defects or how
many excess cases of neurologic disease are going to occur in a mil-
lion people who are exposed to a chemical at a certain level. That
is what risk assessment is, and it is something that we achieve
through toxicity testing.

Risk management is what I pay you to do. It consists of the Con-
gress sitting down and saying that as a matter of public policy, we
are going to manage risk so that no more than one excess cancer
occurs in 10 people or in 1000 people or in a million people.

That is not science at all. It is public policy. The two should not
be confused.

I would argue that there is a good case to be made for writing
into legislation the statement — and it is a policy statement, not a
scientific statement — and it is not subject to change as science ad-
vances— that this Nation will not allow more than one excess case
of cancer or more than one excess case of birth defects to arise per
million people exposed to pesticide chemicals.

That is your call, not mine.

Senator Daschle. But setting the standard is really a function
of both management and assessment, and, I mean

Dr. Landrigan. Well, it is based on the assessment. It is based
on the scientific data. But when the Agency sets the standard, they
have to adhere to whatever benchmark you and the Congress pre-
scribe.

Senator Daschle. And that is your standard? Your recommenda-
tion for a standard is to prescribe it in terms of lives per million;
is that it?

Dr. Landrigan. One excess case per million, yes, which is the
same number that Mr. Vroom seemed to accept a few minutes ago.

I think we differ, though, in our approach as saying: Do not write
it into law. I am saying: "By all means, do write into law, so it does
not get eroded in the future."

Senator Daschle. Carolyn?

Ms. Brickey. Yes. One thing that I think gets missed in discuss-
ing this issue is that in a discussion of benefits, it is important to
point out that we are not talking about how many benefits a pes-
ticide has when it comes onto the market. If EPA has evaluated the
pesticide and has decided it is safe enough to be approved, the
product goes on the market. If it is a good product and people want
to use it, they will buy it. Those are economic benefits.

It is not, however, the same thing to say that once a pesticide
has been looked at by EPA and EPA says that pesticide does not
meet the safety standard, that we ought to create an exception for
that product and keep it on the market indefinitely because it has,
quote, "benefits" in the marketplace. That is a position that the
groups that I work with find unacceptable. I do not think it serves
the public health to do it that way.

Senator Daschle. Yes, Mr. Bender?

Mr. Bender. Mr. Chairman, I have almost missed the moment
with this comment. But given your continuing interest in finding
a definition of negligible risk, I would like to partially move back
to something.

Another one of the worries about negligible risk is that it is —
whatever definition we come up with is inherently arbitrary. For
some reason, it tends to converge and has historically on this one
in a million number.

I think that one of the problems with that is that we probably
have not yet found a way to subject that definition to democratic
processes. That is, I am not sure that we have found a way to ask
the American people whether they would prefer to be exposed to,
let us say, a 1-in-a-million risk or 1 in 500,000 or 1 in 2 million.

Senator Daschle. Yes, Mr. Eckel?

Mr. Eckel. Well, Senator, I have remained silent on the issue,
because I believe very firmlv that these decisions as far as food
safety are concerned have to be decisions based on good science and
medical research. I am a farmer. I'm not a scientist nor a doctor.

Having said that, the construction of your question limits my
comment because you did not bring the benefit question into it
until Ms. Brickey did.

The American public could not make a decision on what risk is
acceptable unless they looked at the benefit.

Each of us sitting around this table took a risk in coming here
today. I flew. Then I rode in an automobile. I crossed the street.
Those were very real risks that the scientists and mathematicians
can compute, what risk I took with my life.

I weighed that against the benefits or nonbenefits of the 3 mil-
lion or 4 million farmers in this country who belong to American
Farm Bureau would have if we did not represent ourselves here
today and had agriculture structured without the benefit of our
input. I said: "I will accept the risk."

And so I do not know how we can construct any analysis that
does not take into account the benefit versus the risk. It puzzles
me that while in this area we have been assessing risk and benefit
for over 30 years, and now we think we have to regress, in most
other areas of Government today when I hear issues being debated,
we are saying: Well, we have to analyze the risk against the benefit
and the risk against the cost.

And I would urge you that as you wrestle with the academic
question of the establishment of the risk, to recognize that we must
absolutely include in the legislation the analysis of the benefit, and
I am not just talking about production in agriculture; I am talking
about the consuming public.

Senator Daschle. Well, there is a consensus among the group
that modification of the Delaney clause is appropriate or at least
acceptable.

There is also a consensus that negligible risk, rather than zero
tolerance, ought to be the standard.

There is some degree of agreement, I think, on the way in which
one defines how you establish negligible risk. But I do not think
that there is a consensus in this room with regard to that at this
point.

I wanted to try to do it outside the context of the bills themselves
and see if we could arrive at that before we politicize the defini-
tions by associating them with the bills. But I think we will be here
until midnight just trying to do that, if I were to pursue this any
further.

But I want to depart from this issue, unless somebody else has
a profound closing comment they would like to share with us with
regard to negligible risk and what guidance you would give us.

Let us be honest. I do not think we are there yet. I think one
of the reasons that this committee is not as far along in the process
is because we are still talking out there, rather than toward one
another. Until we start grappling with some of these tough defini-
tions and issues, I think we will be back here, as Senator Pryor
said, years from now.

And so we need to seize the opportunity, and you need to give
us as much of your wisdom and experience as you can in trying to
deal with it as effectively as possible.

I think we have made marginal progress this afternoon. But
frankly I would like to keep the record open, and I would like to
continue to solicit your guidance in this regard.

But it is very important that we address this issue. We cannot
put it in writing unless we understand it in concept and have a
better appreciation of the ramifications of what it is we are writing.
Obviously, judging from the significant degree of concern with the
way that is written, that is a profound problem that has yet to be
addressed effectively in this committee.

Mr. Meyerhoff. Let me just add one point, I think, because I
do not want to get into "the Emperor has no clothes" here.

I am not sure that there is agreement even at this table that so
long as we could define something as negligible risk, we would
have solved the underlying policy questions that are here.

I think that I would talk about perhaps unnecessary risk or un-
necessary exposure, because what I am thinking of when I am say-
ing those words is: How do you drive the technology in agriculture,
which I think benefits the American farmer and the consumer, so
that over the next decade, as we go into the 21st Century, fewer
chemicals are used on the farm, which is to everyone's benefit, I
think perhaps to the farmer most of all?

How we get to that point, we are still far apart, I think.

Ms. Brickey. Could I suggest, Mr. Chairman, just two quick
things that I think are important for this committee to do that
could help this debate?

The first thing is that this committee needs to do everything pos-
sible to assist, promote, cajole, push EPA to reexamine these older
products and get the unsafe ones off the market.

How are we going to create the market for new technologies if
we keep these old, unsafe technologies out there? There is no way.

Farmers are businessmen. They are stewards of the land, but
they are businessmen. They run their farms that way — with prac-
tices that they think are profitable and make it work. If newer
technologies come out and older chemicals go away, those tech-
nologies will be transmitted and adopted.

The second way this committee could help this process is to do
everything possible to promote reduction strategies in the use of

pesticides. As I said in my statement, if we do not attack the use
of chemical inputs directly, we will never really do anything in sus-
tainable agriculture that will benefit the environment and public
health.

Senator Daschle. Good suggestions. Yes, Mr. Eckel?

Mr. Eckel. Mr. Chairman, I would encourage you and your com-
mittee— and I recognize it is the Research Committee — to do as
much as you can to create an environment for our farmers that
provides us the best research and technology possible in the pro-
duction of our food and fiber and to create a system that is consist-
ent and predictable as far as its regulatory functions and that is
not arbitrary or centrally planned in its decisions as far as what
to remove or what to keep, be it an old product or a new product.

One of the problems that we have today is not the reluctance of
farmers to use the new technology; as I indicated, I am using that
every day.

The problem is that companies are discouraged from investing.
When you talk about arbitrarily taking products off the market,
who is going to invest in the new one? And that is part of the prob-
lem that I see that we are creating today with this doubt.

There is one other thing that I want to emphasize to you as the
Chairman of this committee, and that is that this agricultural sys-
tem that we have is a highly productive unit, but I think unfortu-
nately taken for granted and far more fragile than what one would
assess.

The fragility comes from the uncertainty of the farmer producer
as far as his future and as far as his liabilities. The considered leg-
islation proposed by the administration in this area is not different
than it is in areas of labor and the environment or the Clean Water
Act, where we talk about civil suits and civil actions and the liabil-
ity of the agricultural producer, which is creating an environment
back home where we do not know whether to stay in the business
or not.

In 1982, Penn State University recognized myself, my brother,
and my father as master farmers. We run a successful, profitable
farming operation. I am 47 years old and should be investing in the
future.

I have a friend in that same situation, another master farmer.
Five are selected from about six northeast States each year — a
select, successful group. He has the same feelings.

One might ask why? And the answer is very simple. We have
been willing to endure the uncertainty of weather and of markets.
We are becoming unwilling to accept the uncertainty of Govern-
ment regulation and the economic uncertainty of financial success
in the future as everyone zeroes in on us as an improper steward
or operator.

One last concern — we will check the record to see if it is accu-
rate.

When the Alar scare was raised a few years ago, before I made
a comment on it as President of the Pennsylvania Farm Bureau,
I asked for a meeting with Dr. Charles Kroger from Penn State
University's College of Food Science, not agriculture, to discuss the
risks that were involved and implied with the Alar situation. I told

him: "Try to create it in layman's language that I, as a farmer,
could understand." I also asked him to assess those risks.

He indicated to me that the risk from consuming that Alar-
treated apple was the same as drinking water out of the public
water supply. It was out of five times the same as breathing the
air in this room. -

He made one other comment that I cannot help but think, sitting
at this table. He said: "94 percent of the carcinogenic risk from con-
suming food is naturally-occurring; 6 percent comes from pesticide
use."

We sit here today and seem convinced that we will eliminate all
of our concerns if we deal with the pesticide question.

I urge the committee to take a strong look at the direction we
are going, the environment we create, and give strong consider-
ation of weighing the benefits against the risk.

Senator Daschle. Let me move on to kids. I know that several
wits made reference to children and the recognition that children
are not adults and that we need to appreciate tolerance accept-
ability in a different context when it comes to children.

I was interested in the report, "Pesticide in the Diet of Infants
and Children." The quote that caught my attention was: "To ensure
compliance with good agricultural practices, tolerances are not
based primarily on health considerations." That is a quote from
"Pesticide in the Diet of Infants and Children."

Dr. Vroom, in testimony — or Mr. Vroom, in testimony before the
House, suggested precisely the opposite, that "pesticide tolerances
are not set at particular levels in order to provide agricultural ben-
efits," end quote.

So there seems to be some difference of opinion as to what it is
that determines tolerance levels. Is it production or is it health, es-
pecially as it relates to children?

I would be interested in a discussion on that point.

Mr. Vroom, do you want to start? Are the two comments at odds
with one another?

Mr. Vroom. The system by which our industry's products are
regulated are required under the protocols developed by the EPA,
published in the FEDERAL Register and of longstanding existence.
So the threshold that is established for the tolerance is computed
off of a model based in laboratory analysis exposing laboratory ani-
mals at a "no-effect" level, but we are also required to test and ex-
pose animals at much higher doses than that.

And all of that data is weighed by EPA scientists. At the no-ef-
fect level, we are then forced by the Agency's approach and proto-
cols to put a safety factor on top of the no-effect level, which gives
you an additional margin of safety, below the no-effect level.

At this point the registrant (the manufacturer of the compound)
has to figure out what crops to put on the label within the avail-
able exposure acceptance, known as the tolerance level.

So we believe fundamentally and firmly that tolerances are in-
deed based in a health assessment and knowledge that comes out
of hundreds of millions of dollars of laboratory testing conducted
under protocols published by EPA.

We also believe that Dr. Landrigan and his panel are correct in
suggesting that improvements can be made. They are incremental

improvements, not improvements that would suggest that the sky
is falHng and that Chicken Little would predict that American agri-
culture is poisoning all of us.

But incremental improvements can be made, should be made,
and the system can be changed. That flexibility exists in the cur-
rent law for EPA to make those regulatory changes.

They have already made some changes in the process and new
legislation is not required to force EPA to do that. I think there is
adequate public pressure from the Academy, as well as the news
media coverage of the Academy's report. Progress is being made.

Senator Daschle. Do you share that view. Dr. Landrigan?

Dr. Landrigan. Well, not completely. Tolerance, of course, is like
a speed limit; 55 miles an hour, at least in my State, is the toler-
ance for driving on the highways, 65 in some Western States.

The basic problem is that some of the tolerances for some chemi-
cals are set at several hundred miles an hour or even 1000 miles
an hour.

Under section 408, tolerances are established through a bal-
ancing process. Health considerations figure in, and toxicity test re-
sults figure in. But these factors are then weighed against eco-
nomic considerations and considerations of agricultural practice.
The unfortunate reality is that in that balancing process, the
health concerns often lose out.

Let me talk in a little bit more detail about a document I men-
tioned earlier. Senator Kennedy asked Ms. Linda Fisher, who in
the previous administration was the assistant administrator of
EPA for Pesticides and Toxic Substances, to provide the Senate Ag-
riculture Committee with a listing of pesticides for which the toler-
ance exceeded what is called the reference dose. The reference dose
is also referred to as the "acceptable daily intake"; it is a number
that is more or less health-based that tries to quantify the con-
centration of pesticide that can be safely allowed in a food.

There were a couple of pesticides at the top of this list for which
the level tolerance exceeded the reference dose by a factor of more
than 1000. There were 2 or 3 single-spaced pages of chemicals for
which the tolerance exceeded the reference dose by a factor of more
than 100. In short, there are a lot of chemicals where too much
pesticide is allowed in food to be safe for children.

Now I accept what Mr. Eckel has been saying. The American
food supply is, to be sure, the best in the world. I have worked in
Third World countries. I have seen children with kwashiorkor
dying of malnutrition. I have been in Nigeria; I have been in El
Salvador; I have seen malnutrition there close up. Also I have seen
malnourished kids in our inner cities in this countrv.

But these are two different issues. We are talking here about
making the world's best food supply better. We are not comparing
the United States with a Third World country.

And I really think that the power exists within our Nation's agri-
cultural enterprise and within this Congress to accomplish just
that.

Senator Daschle. Is it possible to set a single safety standard
for kids and adults?

Dr. Landrigan. Well, as a pediatrician I would proceed by identi-
fying children as the most vulnerable members of our population

and then I would set the standard low enough so that the members
of the most vulnerable group are protected. If the most vxilnerable
are protected, then everybody is protected and you achieve the goal
of a single standard.

Senator Daschle. Mr. Vroom, I saw you shaking your head, that
you thought it was. Is that the standard you would use?

Mr. Vroom. Not exactly, but I think — we are certainly in the
same universe and on the same page and within the same book of
answers.

Unfortunately my scientific advisors are not here, and so I am
struggling to try to remember what I know about the reference
dose number that is in the letter that Linda Fisher submitted to
Congress that Dr. Landrigan is referring to.

It is a separate set of numbers that were devised primarily, as
I recall, for an acute exposure measurement and were devised sep-
arately from carcinogenic effects considerations. I would like to be
able to submit to you our perspective from a scientific standpoint
about those comparisons of tolerance versus reference dose, and I
am just not in a position to be able to give you any more informa-
tion than that, because I do not have my experts with me.

But let me say again that I believe that Dr. Landrigan and our
industry agree fundamentally on the fact that we can get there. I
think that his statements today might lead one to believe that the
sky is falling and that some kind of wholesale change is required,
that perhaps Congress needs to jump in and force action.

It is our belief that EPA is carrying out, in an orderly fashion,
the recommendations of the NAS report on infants and children
and that incremental progress is underway and that no extraor-
dinary pressure additionally from Congress or change in law is nec-
essary, given what we are seeing in the way of progress.

And I would be interested to know whether you agree with the
fact that the Agency is progressing, Dr. Landrigan?

Dr. Landrigan. Well, the sky is not falling, nor does the Na-
tional Academy report say that it is.

What we said is that the present pesticide tolerance-setting sys-
tem needs to be improved. The Agency is making some progress.
They could perhaps use some prodding from the Congress.

Mr. Vroom. They could certainly use more resources from the
Congress.

Dr. Landrigan. They could use more resources. We agree on
that.

Senator Daschle. If there is no other comment on that issue, let
me just

Mr. Meyerhoff. Let me say one thing on Alar, since it was
brought it up.

Senator Daschle. Yes, Mr. Meyerhoff?

Mr. Meyerhoff. Because I think it is a good — maybe it is a text-
book case of why the existing system does need reform, and you
can cry wolf, but you can also cry sheep. Every committee of this
Congress that has looked at the pesticide law for the last 30
years — I can go back to the Moss Committee, you know, more than
20 years ago that found that the American pesticide laws — and this
is a direct quote — "are an abysmal failure and in need of a com-
plete overhaul."

I do not think we need to debate at much greater length that the
existing system does not work, at least not work as well as it could.
I do not think it benefits the American farmer, frankly, to have ag-
riculture be the number one source of surface water pollution in
the country, to have drinking water wells in California being closed
down because of DBCP, to have problems in the Great Lakes where
we are finding wildlife that are being deformed in all likelihood be-
cause of DDT and other chemicals.

I think that we do need to change things here. When it comes
to infants and young children, I would first point out that the risk
to infants and young children, as quantified by EPA from Alar,
were greater than 1 in 10,000. Our assessment was 1 in 4000. You
know, Mr. Vroom's number was 1 in a million.

And EPA recently reaffirmed, based upon the industry's own test
data, that that chemical, using a cost-benefit standard, should be
off the market. So I believe that the acted correctly on Alar, al-
though 20 years too late, and an entire generation of children was
exposed unnecessarily to a chemical that was a probable human
carcinogen.

And I go back to lead. I think the model for infants and children
should be the model we have used for lead. We would not say: Let
us have a little bit of lead in infant formula. We would not say: Let
us have a little bit of lead in gasoline, when we can remove it. If
you can reduce or eliminate exposure to these compounds, whether
it is lead or dioxin or the 73 pesticides EPA has now said cause
cancer, the policy should be to find ways to reduce or eliminate
that exposure.

Senator Daschle. Thank you, Mr. Meyerhoff.

I want to finish our hearing here this afternoon. But I would like
to throw out one last issue that critics and advisors alike have
given us a good deal to think about, and that has to do with en-
forcement powers and the time within which decisions are made.
Obviously that has a profound effect as well on everybody at the
table.

Is there a consensus about the need for enhanced enforcement in
some circumstances and the need as well for expedited decision-
making?

Ms. Brickey. I do not think there is any question that we need
expedited decisionmaking. A chemical that triggers what EPA calls
a "special review," which means there is a health problem here we
have to deal with, can sit over there for 7, 10, 12 years before final
action occurs. That is unacceptable.

The legal procedures that are involved in taking a chemical off
the market once the Agency decides the chemical is unsafe are hor-
rendous. There are all kinds of barriers to leap through to get that
done.

The law is broken and needs an overhaul. This committee knows
very well how difficult and tough these issues are. But the law is
not working the way it was intended to work.

Senator Daschle. Does everybody share that point of view?

Mr. Vroom. No, Senator.

Senator Daschle. You do not.

Mr. Vroom. I agree that special review is what consumes great
amounts of time in terms of analyzing a theoretical or a potential
problem with regard to one of our compounds.

Special review does not exist within FIFRA. It is a policy that
was manufactured by the Environmental Protection Agency and
not prescribed by law passed by this Congress.

The law says that you take three steps in cancellation. One is
consultation with USDA. Number two is that EPA consults with a
science advisory panel. Number three, it goes to an administrative
law adjudicatory hearing.

There have been three cancellations of products in recent years.
In the provisions that are prescribed by FIFRA, those 3 steps, the
average amount of time that those 3 steps have taken is 21 days
for the cancellation hearings. The longest was 35 days. It is not
several years.

What takes time, in terms of special review are in many cases
EPA requiring tests to be redone because they lost the data that
was submitted originally, or there is a change in the thought proc-
ess at EPA with regard to the protocols under which a test was
done. Sometimes these are 3-year animal studies. You cannot redo
a 3 -year animal study in 90 days.

So Congress ought to give some encouragement to the Agency to
streamline the special review process and perhaps bring it further
out into the open. But that which is prescribed in law on cancella-
tion does not take that much time.

Mr. Meyerhoff. We said support an amendment to FIFRA that
would require that cancellation hearings be completed within 30
days.

Senator Daschle. Within 30 days?

Ms. DuGGAN. Absolutely.

Mr. Meyerhoff. If 21 days is the model, I would fully support
that.

Senator Daschle. Does anyone disagree with that?

Ms. DuGGAN. The food industry is very supportive of trying to
streamline the cancellation process, and we have traditionally sup-
ported moving to a notice and comment type system instead of the
adjudicatory hearing.

But these are really splitting hairs. I mean, what we want to do
is get from something below 6 years to maybe 16 months, and we
think that those kinds of provisions are in 1478 and in some of the
other bills — this is actually a place where there is some conceptual
agreement with the administration in the industry.

You also need to be able to give them the ability to decouple sus-
pension from cancellation, so they can move forward on one with-
out having to do both.

And from our point of view, that was one of the biggest issues
in Alar, is that they could not decouple suspension from cancella-
tion, and if they had had that ability, it would not have taken so
long.

Ms. Brickey. The suspension provisions in the administration's
bill and in your bill would not address the suspension issues that
were part of the Alar controversy.

Ms. DuGGAN. Perhaps. But they still need to be done. But it still
needs to be done. We think that will go a long way to improve the
decisionmaking.

Senator Daschle. Well, this has been an extraordinarily produc-
tive session for me and I know for my colleagues. I really appre-
ciate everyone's willingness to share their views with us and to
present the testimony. We have got quite a diverse group, but I do
believe that through that diversity comes education, and we have
certainly been educated this afternoon.

The record will remain open for 5 days. If anyone wishes to make
additional comment, they are welcome to do so.

Again, my thanks to all of you for being here.

[Whereupon, at 4:39 p.m., the subcommittee was adjourned.]

APPENDIX

PREPARED STATEMENTS

Carolyn Brickey

Mr. Chairman, and Members of the subcommittee, thank you for this opportunity
to express the views of the National Campaign for Pesticide Policy Reform about
the administration's proposal and the need for pesticide reform. I am executive di-
rector of the Campaign which is a clearinghouse for a coalition of 51 organizations.
A list of the coalition is attached. ^ 1 think that an important first step before evalu-
ating any pesticide proposal is to ask ourselves what is wrong with current law.

First, too many regulatory burdens fall on EPA. This is important not because we
are sajdng "poor agency," but because there are insufiicient resources to overcome
the burdens. The consequences of this overburdening are real. Some examples of it
include:

(1) There is a bias toward old chemicals that stay on the market. This results in
a critical stumbling block to replacing bad technologies with newer, better ones. You
cannot drive the development and adoption of a safer method (less pesticide reliant
pest management systems) with "old tools" (conventional farming practices and
heavy chemical applications).

(2) The Agency has a heavy legal burden to show that the risks of a pesticide do,
or do not, exceea the so-called "benefits standard." As a result, EPA scientists tend
to ask for another study when confronted with new information about the health
risk of a pesticide. It takes a year or two to obtain and evaluate the new study that
may result in yet another study, and so on. This is a kind of data deadlock that
prevents the job from getting done, and is why a pesticide may sit in special review
for 10 or 12 years.

(3) The cumbersome procedures of FIFRA add to the difiiculties presented in A
and B above. The resource drain and time involved, and adjudicatory loopholes
available in suspending or cancelling a pesticide far exceed other health and safety
statutes. It's a lawyer's paradise if ne or she is representing a pesticide manufac-
turer, but it does not serve the public.

The result is that little gets done. The program becomes a paperwork treadmill.
The objective becomes managing the paper not the risk. This is the primary function
of the current program.

The solution is to place the burden on the registrant where data are inadequate.
The responsibility to turn the "unknown" into the "known" should be on the reg-
istrant. For example, EPA is examining hundreds of older active pesticide ingredi-
ents in the reregistration program. If the registrant does not provide requested data
within EPA's deadline, the product is suspended. This is a data forcing mechanism.

Second, "new science" is not taken into account. For all of the industry's talk
about sound science and how outdated the Delaney clause is, there is little decision-
making in the pesticide program to reflect the newer public health concerns about

1 Retained in Committee files.

(43)

health effects beyond cancer. A grossly over valued risk assessment system prides
itself on the use of "Q Stars" (risk factors) and other terminology that does not take
multiple exposures into account, assumes that cancer is always the most sensitive
endpoint that must be used to regulate pesticides, and does not adequately protect
children and farmworkers from pesticide exposures.

The concept embedded in the Delaney clause of preventing exposures by keeping
a harmful pesticide out of our food, water, and environment seems prudent to me.
More to the point, however, new science is not about blasting Delaney. It is about
pesticides and other chemicals that may cause irreversible damage to developing
embryos leading to loss of function of the endocrine, immune, and nervous systems
in exposed individuals. It takes only an extremely small quantity of these chemicals
at a critical time during development to lead to these functional deficits. The efTects
are often not visible at birth and are more often expressed as the individual ma-
tures, leading to neurological and immune problems, and reproductive dysfunction,
including reduced fertility. These effects tnat appear to be hormone-like, causing
disruption of the endocrine system, are serious health effects that we are only begin-
ning to understand how to test and detect, much less regulate.

Third, sound science tells us that the current tolerance-setting system isn't pro-
tecting children from unsafe pesticide exposures. A set of carefully considered rec-
ommendations from the National Academy of Sciences (NAS) must be thoroughly
implemented to protect children. There should be no room for politics here. A little
bit of discretion can be too much of a bad thing. The law must put the burden on
the manufacturer to provide the data when the company wants to keep a pesticide
on the market and EPA says the product is too risky for exposure to children. In
the absence of data proving safety for children, the pesticide should be removed
from the market. The only way to drive the production of data is to put the burden
on the registrant.

Fourth, both F'IFRA and FFDCA as currently constructed are overlv discretionary.
Is this an indictment of EPA? No. There are many well-intentioned., hard-working
folks at EPA who try to do the right thing, but without a legal mandate, individual
decisions become too politicized to make. The manufacturer complains, certain agri-
business interests complain, and the system becomes mired in red tape.

I must say that those farmers who actually use pesticides and complain about los-
ing unsafe ones remind me of airline patrons who scream because thev can't get
flights in hurricane weather. Does one really want to fly in that weather? Some-
times members of Congress complain and threaten to intervene legally. Historically,
0MB complained, USDA complained . . . the result was that resources were used
to defend a decision that is designed to protect the public and subject it to undue
delay, weakening, or even inaction. This is not about which party is in power; it
is about the ability to act quickly and decisively to protect public health.

Every knowledgeable person in Congress can think of examples where this inter-
vention in the process occurs. Does this mean that I think there should be no in-
volvement by affected groups, inter-agency process, or that registrants shouldn't
have their say? Of course not. But it does mean that once meaningful public partici-
pation is over and EPA has concluded that the pesticide has one or more unsafe
health impacts, decisive and swift action should occur. That seldom happens.

Fifth, new action-forcing mechanisms are needed that require regulatory action
once an administrative finding is made that a pesticide has one or more unsafe ef-
fects.

Changing the food safety law will not be effective if substantial and concurrent
amendments are not made to FIFRA. FIFRA is too much about managing the use
of pesticides instead of reducing the dependence of on chemical pesticides. The new
law needs to implement a reduction in the overall use of pesticides where possible.
Research and technology transfer must be connected to replace pesticides that are
unsafe particularly where current alternatives are limited or are not readily avail-
able.

Sixth, we need to end the double standard which results in the annual export of
at least 100 million pounds of pesticides too dangerous for our own use here. These
include those which have been banned or never even get on the domestic market.
One recent example is the insecticide mevinphos (Phosdrin) which was taken o IT the
domestic market June 30 for causing farmworker poisonings in the United States
but may continue to be made and exported for use by farmworkers overseas.

The double standard is both a moral and economic one — moral because current
law implies that the lives of others overseas are less important than those of people
in the United States and economic because farmers overseas will continue to be aole
to use pesticides like mevinphos which are illegal for use by our own farmers.

These are the yardsticks that I believe must be used to evaluate any new pro-
posal. The Administration bill meets some of these tests, but not all. Recommended

FIFRA reforms represent an improvement over current law however, with impor-
tant exceptions where provisions should be strengthened or deleted. FFDCA provi-
sions that set timetables for revisiting tolerances that EPA finds will meet a new
health standard are the most important reforms in either Administration bill. Other
provisions take progressive steps to protect children from pesticide residues but do
not go far enough to eliminate barriers to change.

EXPORT CONTROLS

Some needed changes in the way pesticide exports are regulated are proposed in
the Administration bill. For example, a more aggressive United States leadership
role is envisioned in this proposal than in previous administrations'. It would be ille-
gal to export pesticides banned for human health efTects as well as other pesticides
if a country requested us to stop their export. However, unregistered exports are not
treated stringently enough to ensure that citizens in other countries and food im-
ported to the United States are not harmed by United States pesticide exports. Too
many exceptions and loopholes exist in this plan. There are often health and safety
reasons that block the approval of a product in the United States that may be ap-
proved in another country.

PHASE-OUT AND PHASE-DOWN AUTHORITY

This new authority is an improvement over current law. It is, however, an exam-
ple of good intentions that must go further. It does not require or trigger a strong
regulatory response to newly discovered information about serious health effects.
The provisions of H.R 4091, the Waxman bill, better reflect an approach to require
action by the administrator when pesticides are classified as "highly hazardous"
health threats.

These triggers would be activated when pesticides cause serious reproductive
harm, are probable carcinogens, endocrine disrupters, bioaccumulative, highly per-
sistent, or are Toxicity Class 1 pesticides. The Waxman approach represents a rea-
sonable action-forcing mechanism which would remove some of the worst pesticides
from the market, and allow some additional time to develop alternatives for those
pesticides truly without substitutes. S. 1478, the Lugar-Pryor bill, includes no new
action-forcing mechanisms.

Providing for an orderly marketplace transition from 1950's technologies to prac-
tices that will take agriculture progressively into the 21st century is desperately
needed. We are not helping farmers by encouraging the status quo — just like we
wouldn't be doing a favor for the airline passenger who gets his or her wish to fly
in a hurricane.

MINOR-USE PESTICIDES

First, the issue and then the concern. There is a real anxiety on the part of cer-
tain producers that will or are "losing" pesticides in the reregistration process. I con-
tinue to believe that there are three primary reasons for such losses by minor crop
producers. The first is that a registrant decides that a certain pesticide will not
meet newer health and safety requirements and so the registrant drops the rereg-
istration effort.

The second is that a company has had a registration that is only marginally prof-
itable because the "major" uses — wheat, corn, cotton, or rice — have been overtaken
by newer products, and it is not worth the cost to perform core health and safety
tests on the product.

The third situation exists when the registrant registers or reregisters a product
for one or more "major" uses but is delayed or reluctant to pay several hundred
thousand dollars for residue chemistry tests for one or more minor uses.

In neither of the first two cases is it feasible or reasonable to ask the taxpayer
to foot the bill for these expensive tests. So what then is the minor use answer?
There are two things that public and private sector research can agree to — develop-
ing and transferring newer nonchemical alternatives to farmers of minor crops and
assisting them to access residue chemistry more quickly for safer, new pesticides in
the short-term.

The answer cannot be to allow unsafe pesticides on the market longer just to sat-
isfy the needs of producers for older, cheaper pesticides. Instead, gaining access to
new products and technologies is the answer for farmers. Producers of minor crops
should get on the front of the train, not ride on the caboose.

SECTION 18 AUTHORITY

While we recognize that farmers and public health ofiicials can meet with unex-
pected emergencies for which the registered pest control tools available cannot do
the job, the section 18 program continues to fail in its protection of public health
and the environment. Since the adoption of regulations in 1986, which were in-
tended to rein in the program, we have seen a significant increase in the issuance
of permits across the board. This raises serious questions about the effectiveness of
the program, not only in its response to pest problems, but as a means of promoting
the adoption of practices that prevent future emergencies.

When evaluating EPA's emergency permits, we see that the problem of repeat
emergency exemptions persists. EPA estimates that more than half of the section
18 exemptions granted during fiscal year 1988-91 were granted for at least two con-
secutive years.

Section 18 may be used to either promote or discourage the implementation of
pesticide use reduction strategies. States and EPA shoula be required to showcase
successful management systems that use a minimum of toxic chemicals, and these
should be complete systems. If the law and its implementation addresses the system
as a whole and requires States to undertake preventive action, then reduced use
systems can be enhanced. The program must consider nonchemical controls, and
prohibit consideration of the contribution of agricultural practices that constitute ob-
vious mismanagement, which could be used to promote biological approaches to pest
management. Beyond changing the basic thrust of the program to ensure that the
section 18 program breaks the cycle of pesticide reliance on increasingly toxic mate-
rials, the program should: (i) notify all interested parties, including the public, of
the opportunity to comment on all applications for exemptions; (ii) not allow the use
of unregistered products or those with significant health and environmental testing
data gaps; (iii) ensure enhanced Federal enforcement of use restrictions and other
compliance questions; and (iv) require use records and improved oversight of State
enforcement of the program.

PESTICIDE RECORDKEEPING

The significant difference the Campaign has with the administration's bill is that
we need use reporting as well as recordkeeping. Reporting is clearly a victim of po-
litical rhetoric, because farmers already keep records for business and tax purposes.
The largest States already require that such data be reported. These data can help
inform us about the nature oi pesticide use — ^how much and where. If pesticide use
is to be regulated in a more specialized way to enlaance ground water protection,
for example, reporting of records is needed. Furthermore, if we want to require im-
porters to provide more information, we need to require our own producers to meet
similar recordkeeping requirements.

Most savvy farmers do not fear use reporting because they know that use records
will show that they are running their businesses by the book. They are not afraid
to report and share their records with the public. It is time that Washington, DC
catches up with the real world on this issue.

CITIZEN SUITS

This is a good concept from which no farmers should be exempted. Why? Because
its real purpose is to get State agencies to enforce the law. It is also a good incentive
to get everyone to follow the law when all parties are on notice that a lax enforce-
ment agency won't protect their illegal action. Finally, we have to remember that
there are few field personnel and small budgets to enforce the law. We are almost
dependent on the good will of producers. There is a lot of that but not enough to
always protect the workers and neighbors of some farmers. In addition, provisions
for citizen suits in other environmental laws, despite dire predictions to the con-
trary, have been implemented and the sun stiU rises in the morning.

A NEW HEALTH STANDARD IN THE FFDCA

Use of the "reasonable certainty of no harm" standard is an improvement over the
standard in current law, section 408, which encompasses a version of risk-benefit
analysis. However, a great deal of discretion is allowed in the proposed standard
which is premised on the very imprecise concept of negligible risk. S. 1478, the
Lugar-Pryor bill, allows even more discretion. Numbers are the name of the game
in this arena, and they can move the risk up or down — mostly down — dramatically.
Also, don't forget that to get this new discretionary standard, the Delaney clause
would be deleted — a trade that is too expensive unless strong health-based man-
dates that expand tough protection for other health effects besides cancer are in-

eluded in the law. Further, delaying the health standard or phasing it in to re-
place— finally — economic benefits is not good policy. Economic benefits, as defined
in current practice, are too narrow and parochial. Remember that we are talking
about exceeding the new health standard in order to use these benefits. Only a true
lack of alternatives or an averted health risk should ever be figured into the cal-
culus of eliminating a pesticide based on its health risk.

TOLERANCE ASSESSMENT DEADLINES

This is the heart of the administration's bill. Damage it and the body stops work-
ing. Without these new requirements to force registrants to show that tolerances
meet the new standard, reregistration will continue to rattle along at a stultifying
pace — one that does not reflect risk reduction priorities.

Yet too many of the administration proposed provisions are based on evaluation
of data "where it is available." These provisions do not drive data; they merely re-
quire its use where it exists. This is a major difficulty in the way in which the ad-
ministration proposes to reassess pesticide residues to better protect children. The
lack of provisions driving the development of new data and making it the respon-
sibility of the registrant is a major failure of the Administration bill. Remember,
this is one of the yardsticks I mentioned — ^burden shifting to the registrant and end-
ing the data deadlock.

RISK REDUCTION VERSUS USE REDUCTION

While risk reduction is an important goal of EPA activities, it is limited in scope
in several ways. First, the process of regulating one pesticide at a time is like tying
your shoes together and trying to walk around the world. Could anything be slower?
Second, the lack of cumulative risk evaluation means that often exposure to a num-
ber of different types of compounds is truly understated and ignored.

Third, one has to know or suspect that there is a specific problem in order to act
on it under the risk reduction paradigm. Fourth, despite the presence of pesticides
in ground and surface water nationwide, little is being done to eliminate pesticide
leachers.

Despite the new devotion to the concept of Integrated Pest Management (IPM),
pesticide use per acre is going up. Since 1966, the pounds per acre of active pesticide
ingredients applied to United States cropland have increased 125 percent. In 1966,
1.2 pounds per acre of active ingredients were applied. By 1991, the amount had
increased to 2.7 pounds per acre. One in 10 wells is contaminated with at least one
pesticide, and more than 440,000 rural wells contain pesticides. Levels of Atrazine
and Alachlor have exceeded Federal drinking water standards in the Mississippi
river basin by 52 and 32 percent, according to USGS. On a one time/one hit basis,
the levels are far higher: 1000 times the E!pA standards for Atrazine, for example.

Reducing the use of pesticides in our environment is an important, cost-effective
pesticide-related act of pollution prevention we as a society can take. Two recent re-
ports document the wisdom of this approach — NAS' Soil and Water Quality: An
Agenda for Agriculture and the Office oi Technology Assessment's Beneath the Bot-
tom Line: Agricultural Approaches to Reduce Agrichemical Contamination of
Groundwater.

This approach is one that benefits farmers, their families, workers, and commu-
nities. When they adopt alternative approaches, farmers can save input costs and
eliminate contamination risks to their own or their neighbors' wells, as well as sur-
face water near their land. It is the right way to go. This is the way to take high
quality, safe agriculture into the next century. Other countries have already begun
programs to reduce use.

RESEARCH, EDUCATION, AND TECHNOLOGY TRANSFER

How can use be reduced without hurting farm viability? Farmers have been ac-
tively participating in on-farm demonstration and research projects for the last dec-
ade. Small grants provided directly to farmers through the USDA Sustainable Agri-
culture Research and Education Program (SARE), State funded Sustainable Agri-
culture Demonstration Programs and Foundation Grants have shown that profitable
alternatives exist that significantly reduce pesticide use. These on-farm research
projects coupled with field days and farmer led workshops have also demonstrated
that farmers are more likely to implement sustainable practices after being "edu-
cated" by fellow farmers. The concept is "letting the best teach the rest." Using doc-
umentea successes of farmers in a particular region growing specific crops, measur-
able use reduction goals can be implemented. The involvement of State agencies and
the USDA extension service can help promote new strategies. USDA research needs
to focus on experimentation and implementation of environmentally sound agricul-

tural practices. Programs such as SARE need to be expanded and fully funded and
coupled with other USDA programs like the Water Quality Incentives Program
(WQIP) and the Integrated Farm Management Program Option (IFMPO) which pro-
vide incentives and cost sharing for the implementation of proven, environmentally
sound practices. Those actions need to occur now, not in 10 or 20 years.

Clearly, neither use reduction nor risk reduction alone is enough. Both must be
implemented together to have the safest possible food and water supply and a clean-
er environment.

NEW FIFRA CANCELLATION AND SUSPENSION, FFDCA PROCEDURES

These procedures would be vastly improved by the enactment of the Administra-
tion bills. However, there is still no new emergency authority for suspensions. The
bill would not solve the dilemma presented by Alar — a pesticide presenting a chron-
ic health risk to children that EPA repeatedly said should be removed from the mar-
ket more expeditiously than in a regular cancellation. The ridiculous outcome in the
Dinoseb case — where EPA was required to document the impact on every crop use
of a pesticide that was causing serious reproductive hazards — would be overridden
by this bill. S. 1478, the Lugar-Pryor bill does little to remedy this problem. A bill
Senator Lugar introduced 3 years ago better addressed this problem.

COORDINATION BETWEEN FIFRA AND FFDCA

The administration's FIFRA bill makes it clear that if a pesticide tolerance is re-
voked or a petition is denied, the registration must be cancelled or amended to re-
flect this action. However, the administration's FFDCA bill does not include a provi-
sion to revoke a tolerance if a registration is cancelled. Why? Some kind of interim
food chain pipeline can be provided for in addition to this needed corresponding
change. Again, this should not be a discretionary matter. It takes time and re-
sources to act affirmatively on this matter. Sometimes the action is far from expedi-
tious.

NEW LABEUNG AUTHORITY

EPA badly needs new authority and control over product labeling. In certain cir-
cumstances the Agency has in the past not known the actual contents of an older
product it is asked to register. Nor could it insure that the label actually met the
requirements of the law.

Albert H. Meyerhoff and Jennifer Curtis

INTRODUCTION

I am Albert H. Meyerhoff, senior attorney with the Natural Resources Defense
Council (NRDC), a national nonprofit environmental organization dedicated to pro-
tecting the public health and the environment with over 170,000 members. For more
than two decades, NRDC has been actively involved in the host of issues presented
by the increasing use of pesticides and their impact on the environment. I appre-
ciate this opportunity to testify today regarding legislation proposed by the Clinton
administration to amend Federal pesticide laws. Before addressing the Administra-
tion bill, however, I would like to briefly summarize the administration plans to
obey the law as written.

THE DELANEY CLAUSE: A CLEAR AND PRESENT MANDATE

As one of her first acts following confirmation as EPA Administrator on February
2, 1993 Carol Browner indicated that one of her top priorities was to achieve com-
prehensive reform of the Nation's antiquated food safety laws. However, as a condi-
tion of that reform, which included replacement of the Delaney clause, she indicated
that the pesticide laws should be amended only if to do so would "give the public
more protection, not less." {New York Times, February 1, 1993 at p. 1.^)

Absent legislation, and unlike its predecessor, this administration has repeatedly
emphasized its conunitment to comply with and fully implement existing law, in-
cluding the Delaney clause. Thus, at a September joint hearing of the Senate Labor
and Human Resources Committee and the House Energy and Commerce Conunit-
tee, Subcommittee on Health and the Environment, Administrator Browner stated
EPA's intent to comply with the precedent established in Les v. Reilly and imple-

2 Retained in Committees.

ment Delaney in a timely fashion. (Hearing on Legislation to Amend the Food, Drug
and Cosmetic Act, Washington DC, September 21, 1993.)

At an October 1993 House Government Operations Subcommittee hearing, Dr.
Goldman spelled out the Agency's intention in more detail:

[EPA will] immediately discontinue processing applications for experimental use
permits, product registrations, and petitions for tolerances for chemicals that
are potentially aflected by the Delaney clause. It makes little sense to expend
Agency resources to process applications for the same sorts of uses which we
are in the process of revoking . . . [T]he clear legal interpretation of the U.S.
Ninth Circuit Court's decision plainly applies to a number of other chemicals
and their tolerances. Although there are a number of legal and policv issues
which EPA has not yet settled, I have decided that we can quickly begin to
make the policy choices and initiate actions on a number of existing tolerances.
Accordingly, I expect that additional notices to revoke section 409 tolerances
will be proposed within a matter of months. (House Environment, Energy and
Natural Resources Subcommittee, Government Operations Committee, October
29, 1993.)

In response to questions from Subcommittee Chairman Synar, Dr. Goldman then

grovided^a list of carcinogens potentially subject to Delaney, indicating that under
PA's plan for these chemicals, the Agency ' will establish priorities and schedules
over the next year for revoking food additive regulations and raw food tolerances,
as well as possibly canceling registrations."

Responding elsewhere to industry criticism of EPA's intention to act on §408 as
well as § 409 tolerances in order to fully ensure compliance with the Delaney clause,
the Assistant Administrator has also stated that:

The EPA disagrees that it is mistaken to invoke the Delaney clause for raw
tolerances under all circumstances. We are aware that, in many cases, the
farmer does not know ahead of time whether a given crop is destined for
the raw or processed market. It would be misleading and disruptive for the
EPA to grant raw tolerances in circumstances where later the crop is des-
tined for the processed market and, therefore, would have violative resi-
dues. (Pesticide and Toxic Chemical News, November 10, 1993, at 20.)

This administration's express commitment to Delaney implementation is refresh-
ing since, in the past, at least for pesticides, the Delaney clause has been honored
in the breach. The Agency's consistent approach throughout the 1980's with respect
to carcinogens in food was to ignore or evade that historic statute. This approach
is no longer legally permissible. The United States Court of Appeals has held, in
Les V. Reilly, that pesticides present in processed foods, either diie to concentration
during processing or postharvest application, are subject to Delaney. The Agency's
purported de minimis policy, allowing carcinogens based on the purported level of
cancer risk, was rejected because "the language of the Delaney clause, its history
and purpose, all reflect that Congress intended the EPA to prohibit all additives
that are carcinogens, regardless of the degree of risk involved." (,Les v. Reilly)

Moreover, under the Agency's well-established policy, and because EPA is unable
to determine which raw commodities will or will not be processed, the presence of
carcinogenic pesticides in raw commodities that are subject to processing is fore-
closed as well.

Beginning to fulfill this commitment to Delaney compliance, EPA has now issued
an updated list of those carcinogenic pesticides that have been identified as subject
to the Delaney clause (copy attached). This is an important first step. However, in
order to obey the law and protect the public health, it is now incumbent upon the
Agency to take all appropriate steps, in a timely fashion, to revoke those onending
tolerances. It has been 18 months since this administration first announced its in-
tention to obey the law. It is now time to start actually doing so.

THE PROMISE OF THE DELANEY CLAUSE REMAINS UNFULFILLED

The essential premise of the Delaney clause of the Food, Drug and Cosmetic
Act is as simple as it is powerful: what we understand best about carcinogens is
the limited extent of our knowledge. {See "No More Pesticides for Dinner," New York
Times, March 9, 1993, copy attached.^) Accordingly, the famous clause is
grounded in a policy of prevention: prohibiting the addition of carcinogens in the
food supply to prevent avoidable cancers in humans. This approach was deemed nec-
essary by Congress, since the entire Nation's population would otherwise be

3 Retained in Committee files.

routinely exposed to carcinogens in their daily diet. That premise remains as valid
today as it was in 1958.

Accordingly, the philosophy behind the Delaney clause — preventing unnecessary
exposure to hazardous substances — should be preserved — either by implementation
of the existing law or in any new legislation. Prevention is worth a pound of cure.
We still do not know whether humans are more or less sensitive than laboratory
animals to carcinogens and whether one carcinogen may increase the cancer-causing
effects of another. We still do not know the cumulative impact of dozens of carcino-
gens permitted in the food supply and the environment. Our existing tolerance-set-
ting system is entirely predicated on a chemical-by-chemical, crop-by-crop, risk-by-
risk approach, grounded in myopia, "managing" cancer, rather than preventing it.

The reality of life is that we are exposed to a multiplicity of toxic substances. Cal-
culating the combined risks of these exposures is problematic at best; some 300 pes-
ticide active ingredients are used on food as well as an imperfectly examined large
number of "inert" ingredients. For the most part, existing EPA pesticide tolerances
for allowable pesticide residue levels do not even attempt to calculate the aggregate
human health risks presented, nor do they address the cumulative and synergistic
effects on multiple pathways of exposure.

This is the fundamental flaw in the Nation's pesticide laws. And it is the fun-
damental flaw in the administration's proposal which, while improving the current
system, keeps its essential "management" approach intact. We, instead, should fol-
low Rachel Carson's advice of three decades ago:

The ultimate answer is to use less toxic chemicals. This system of delib-
erately poisoning our food and then policing the result is too reminiscent
of Lewis Carroll's White Knight who thought of a plan to dye one's whiskers
green and always use so large a fan that they could not be seen.

THE NEED FOR PHASE-OUT

Since the time the Delaney clause was enacted:

• Conventional pesticide use in the United States has increased dramatically,
from 511 million to more than one billion pounds. Total pesticide use, including
wood preservatives, disinfectants and sulfur now exceeds two billion pounds an-
nually, eight pounds for every man, woman and child in the United States.

• EPA estimates that one out of every 10 public drinking water wells in the Unit-
ed States contains at least one pesticide; their data indicate that nearly 10,000
community drinking water wells and over 440,000 domestic water wells contain
pesticides. Seventy-four diflerent pesticides have been found in groundwater
which supplies drinking water for 32 States. Agriculture is also now the No. 1
source of pollution of surface water; pesticides have found their way into count-
less lakes, rivers, and waterways throughout the Nation.

• According to the FDA, at least 38 percent of the food supply contains pesticide
residues. This understates the actual amount because routine lab tests detect
fewer than half of the pesticides applied to food. Many foods sampled by FDA
had more than one pesticide residue; some had as many as twelve.

• The bugs are winning. At the time the Delaney clause was enacted, 137 species
of insects and mites had become resistant to chemical pesticides. Today, the
number of resistant pests is almost 500 (as well as 100 species of plant patho-
gens and 48 species of weeds).

In 1972, Congress required that the chemical industry test their products and the
Government reassess their safety. For 15 years, this requirement went largely ig-
nored. Finally, in 1988, Congress established explicit timetables by which such test-
ing must be comoleted, to be concluded by 1997, and for pesticides to be
"reregistered" based on the results. Yet, to date, only 27 of 600 active ingredients
have been reregistered (and EPA may miss this deadline by a decade or more).
Nonetheless, in laboratoiy tests, 71 different pesticides allowed in food and the envi-
ronment have now been found to cause cancer.

Mounting evidence suggests a strong correlation between pesticide exposure and
the development of cancer in humans. A National Cancer Institute (NCI) study
found that farmers exposed to herbicides had a six times greater risk than
nonfarmers of contracting one type of cancer. Another study found a link between
breast cancer in women and elevated levels of DDE, a metabolite of the pesticide
DDT, in their fat tissue. Research also indicates that children in homes where
household and garden pesticides are used are seven times as likely to develop child-
hood leukemia. There are still unexplained clusters of cancer among farmworker
children at places such as McFarland and Earlimart, CA.

Those of us bom afler World War 11 — ^the "boomers" — have been accurately called
"the children of the chemical age." It always seemed something of a compliment. But
in a disturbing new study, researchers have found that "baoy boomers" bom be-
tween 1948 and 1957 are far more likely to contract cancer than members of their
grandparents' generation. These scientists found persistent increases in cancer that
could not be accounted for by smoking, aging, or better diagnostic tests. The types
of tumors found to be increasing in the general population were also strikingly simi-
lar to those found in earlier studies of farmers who were exposed to a variety of
carcinogens, such as fertilizers, pesticides, and other solvents.

Authored by epidemiologist Devra Lee Davis, the study, published recently in the
Journal of the American Medical Association, found that cancers unrelated to smok-
ing— that affect parts of the body other than the lungs, throat, and mouth — were
occurring in white male "boomers" at triple the rate of their grandfathers. White
women in the same age group had 30 percent more nonsmoking related cancer than
their grandmothers. {The study was conducted only of whites to avoid statistical
problems having to do with diet.)

Given this record, the case is compelling to, once and for all, end business as
usual. American agriculture must move in a new direction — a direction that simply
relies far less on toxic chemicals to produce our food. The first step in that journey
must be the slow, but eventual, phase-out of "worst actor" pesticides, chemicals
whose hazards have been well-known for up to 50 years. See White Paper: The Need
for a Phase-Out of Carcinogenic Pesticides, Natural Resources Defense Council (copy
attached).^

Thus, while many approaches to do so are feasible, the linchpin of any comprehen-
sive reform legislation must be the accomplishment of the following three goals:

• Comprehensively deal with chronic health hazards from pesticides by phasing
out those toxic substances identified as presenting known hazard to human
health and the environment;

• Respond to the special risks pesticides pose to children as most recently recog-
nized in the National Academy of Sciences report on that subject; and

• Substantially reduce overall pesticide use in American agriculture.

Absent such reforms, the Delaney clause should be left intact and its terms com-
plied with to the full extent of the law. Consider the following:

PESTICIDE REDUCTION: THE POLLUTION PREVENTION SOLUTION

Current regulatory programs have been unable to reduce the hazards caused by
pesticides. Ultimately, the most effective method for protecting public health and
the environment is to reduce the use of pesticides at their source. Numerous reports
document the potential and importance of reducing overall use of pesticides. ' Ac-
cording the National Academy of Science's Soil and Water Quality: An Agenda for
Agriculture NAS report.

Source control to reduce the total mass of pesticides applied to cropping systems
should be the fundamental approach to reducing pesticide losses from farming
systems.^

Several European countries including Sweden, Denmark and the Netherlands
have adopted national programs that incorporate the fundamental approach of pes-
ticide use reduction. Concern about environmental pollution has prompted these
countries to initiate programs aimed at reducing the use and emissions of, and de-
pendence on, pesticides while maintaining viable levels of crop protection without
decreasing crop yields.

Althougn not perfect, these programs are models for what is possible in the Unit-
ed States. The Swedish program achieved a 50 percent reduction in the weight of
active ingredient applied between 1986 and 1991 and an additional 50 percent cut
is currently being implemented. The Danish program achieved a 25 percent reduc-
tion between 1986 and 1990.'

Numerous methods are available to reduce agriculture's use of and reliance on
pesticides. The National Academy of Sciences in tneir report, Alternative Agriculture

■* Retained in Committee files.

^National Research Council, Soil and Water Quality: An Agenda for Agriculture, Washington,
DC. 1993.

Office of Technology Assessment, Beneath the Bottom Line: Agricultural Approaches to Reduce
Agrichemical Contamination of Groundwater, Washington, DC, 1991.

8 Soil and Water Quality, p. 82.

'World Wildlife Federation, Pesticide Reduction Programmes in Denmark, The Netherlands,
and Sweden, November 1992, pp. 2»-34.

documented the potential for reducing pesticide use through the adoption of inte-
grated pest management and other practices and systems for agricultural sustain-
ability. Such practices can lower costs for farmers and pest managers and in many
cases increase the quality, productivity and yields.®

According to a 1991 NRDC report, Harvest of Hope: The Potential for Alternative
Agriculture to Reduce Pesticide use, techniques are available to reduce the use of
pesticides between 25 and 80 percent on nine different cropping systems throughout
the United States.^ Depending on the crop, methods such as integrated pest man-
agement and biological, cultural, mechanical and physical controls can be imple-
mented without significantly effecting crop yields or production costs (Executive
Summary attached). ^°

Federal programs have failed to encourage and, in many cases, have impeded the
adoption of pest management methods that reduce the use of pesticides. Farmers
are interested in implementing new approaches but poorly funded and uncoordi-
nated Federal programs have been of little assistance.

The public is looking to Congress for action. A comprehensive Federal program
that encourages the trend toward reduced use of pesticides is long overdue. Legisla-
tion is needed to mandate a program that includes, at a minimum, the following
major components:

(1) Measurable and enforceable pesticide reduction goals.

(2) Regional, ecosystem-based and crop-specific pesticide reduction programs that
broadly involve farmers and other experts m integrated pest management and sus-
tainable agricultural systems.

(3) Substantial resources directed toward technology transfer for pesticide reduc-
tion, including model demonstration farms and cost-share assistance.

(4) FVioritization of existing pest management research and extension activities
toward development of integrated pest management and sustainable agricultural
systems.

(5) Complete pesticide recordkeeping and use reporting.

(6) Establishment of pesticide reduction goals and programs for all Federal agen-
cies.

(7) Creation of market incentives for farmers including through government pro-
curement of certified-organically grown food.

(8) Development of nationwide initiative to reduce the use of nonagricultural pes-
ticides.

ENVIRONMENTAL ESTROGENS: A WAKE UP CALL

For the reason why pesticide reform is critical, one need look no further than the
Great Lakes, the source of 20 percent of the Earth's fresh water. Due to pollution
from DDT (banned in the 1970's but still "out there") and other "environmental
estrogens," male wildlife are literally being "feminized," born hermaphroditic with
reproductive parts of both sexes or even female entirely. Waterfowl, turtles and fish
also are suffering infertility, gross birth defects, and behavior abnormalities. Else-
where, in the Florida Everglades, alligator eggs are failing to hatch. Male alligators
are being bom with extremely small phalluses, one quarter the normal size, and tes-
tosterone levels so low they are probably sterile. Florida panthers exposed to estro-
genic pesticides have likewise experienced such reproductive failure; lemales are in-
fertile, males sterile with low sperm counts. The "why" is no mystery.

Numerous pesticides and other compounds, like dioxin, lead, chlorine and mer-
cury, have been found to mimic the female hormone estrogen, wrecking havoc on
these animals' reproductive ability. Structurally similar to real estrogen, these com-
pounds fit into estrogen "receptors" in the body, adversely afi'ecting the endocrine
system, disrupting normal sexual development. The most serious reproductive
threat of these toxic substances is not to adults but to the developing fetus, by cross-
ing the placenta during prenatal development. Levels of environmental exposure
causing such effects are surprisingly low, equivalent to those also found in our own
food and water. In other words, what we are doing to the wildlife, we may be doing
to ourselves.

Consider the following:

8 Alternative Agriculture.

^Curtis, Jennifer, et al., Harvest of Hope: The Potential for Alternative Agriculture to Reduce
Pesticide Use, Natural Resources Defense Council, May 1991, p. iii.
1° Retained in Committee files.

• A Danish study of 21 industrialized countries documented a 50 percent drop in
sperm count worldwide between 1938 and 1991. At the same time, the number
01 testicular cancers has tripled.

• In Taiwan, 118 boys born to mothers exposed to PCB's in their diet suffered
reproductive defects including abnormally small penises — the same effect pre-
viously found in both wildlife and laboratory animals.

• Breast cancer will now strike 1 in 9 women. A Mount Sinai School of Medicine
study showed that women with higher levels of the environmental estrogen
DDE (a breakdown product of DDT) in their breast tissue were more likely than
others to get breast cancer. Other studies are to the contrary.

Virtually all of us have measurable quantities of DDE, PCBs and other environ-
mental estrogens in our bodies. "It's very possible and it's frightening that we might
be drowning in a sea of estrogens" said Stanford endocrinologist David Feldman. Is
the evidence conclusive? No. But multiple exposure to literally hundreds of different
chemicals that can turn male animals into females, reduce sperm count, and cause
infertility must be taken seriously. By what right do we risk the reproductive ability
of future generations?

In late July 1991, a multi-disciplinary group of some of the Nation's leading sci-
entists met in Wingspread, Wisconsin to discuss "Chemically Induced Alterations in
Sexual Development: The Wildlife / Human Connection." They concluded they were
"certain of the following: a large number of man-made chemicals . . . have the po-
tential to disrupt the endocrine system of animals, including humans. These impacts
include . . . decreased fertility, decreased hatching success, gross birth deformities,
feminization, and compromised immune systems. The effects are most often mani-
fested in offspring, not in the exposed parent. [HJumans may be at risk to the same
environmental hazards as wildlife."

THE ADMINI^RATION'S PROPOSAL: ONLY A STARTING POINT

In Earth in the Balance, Vice President Al Gore wrote this about agrichemicals:
Over the past 50 years, herbicides, pesticides, fungicides and thousands of
other compounds have come streaming out of the laboratories and chemical
plants faster than we can possibly keep track of them. All of them are sup-
posed to improve our lives . . . But too many have left a legacy of poison
that we will be coming to terms with for many generations.

The Vice President had it right. Last fall, the Clinton administration admirably
chose to break the logjam over pesticides. But, unfortunately, their initial proposal,
reflecting an interagency compromise on agricultural interests and public health,
missed the mark. At best, it is a first step. The proposal is opposed by every major
environmental, consumer and labor organization in tne country. Here's why.

Under current law, residues of dozens of cancer-causing pesticides are routinely
allowed in raw foods, such as fruits and vegetables, through application of a notori-
ously weak, "cost -benefit" standard. On the other hand, as a result of a recent court
decision, pesticides in processed foods are subject to the Nation's most health-protec-
tive statute, the Delaney clause, prohibiting any residue of a known carcinogen. The
Clinton proposal would replace tnis admittedly schizophrenic scheme with a "neg-
ligible risk" standard to apply to all foods — raw and processed.

As always, the devil is in the details. First, the administration proposal does not
specify precisely what constitutes such a negligible cancer risk — or even agree to in-
clude a definition in the statute itself. Instead, identifying the "acceptable" number
of cancers permitted from daily exposure to pesticides in the Nation's food supply
would be left to the discretion of both this and future administrations. Given typical
industry influence over government regulators and the open hostility oi prior admin-
istrations to pesticide regulation, this proposal offers little comfort.

Moreover, for at least the next decade, the administration's new standard will
apply only when it will not result in "disruption of agricultural production." This
loophole is left vague and undefined. But historically, for 30 years or more, virtually
eacn time EPA has attempted to regulate a pesticide — from DDT to DBCP to EDB
to Alar — efforts were stymied by overstated industry claims of just such predicted
"disruptions."

The administration's proposal also responds only with vague generalities to a re-
cent National Academy of Sciences study concluding that existing pesticide laws do
not adequately protect infants and children from their daily dose of these poisons.
And it does not adequately address the cumulative impact of exposure to tne mul-
tiple pesticides found in our foods, including the ability of one toxin to greatly in-
crease the hazard of another, called synergism. Rather than simply assigning indi-
vidual "acceptable" residue levels, on a chemical-by -chemical basis, for the 300+ pes-

ticides used in food, any reform proposal should, instead, gradually eliminate the
use of pesticides already known to pose the gravest threat to numan health.

In addition, the administration's proposal falls short of developing a nationwide
program to reduce the use of and reliance on pesticides. While an important first
step, the administration's proposal is limited to authorizing establishment of re-
duced use pilot projects. Both farmers and the public deserve a comprehensive Fed-
eral program that establishes measurable goals for pesticide reduction, provides
substantial resources for technology transfer and cost-share assistance for farmers
and requires Federal agencies to take the lead in pesticide reduction eflbrts.

Conclusion

Years ago, a House committee found American pesticide laws "to be an abysmal
failure in need of a conriplete overhaul." That conclusion remains accurate. Opinion
polls conducted for the Food Marketing Institute and others confirm that public con-
cern over pesticides is at an all-time high. Serious Congressional reform is required
but will be accomplished only through leadership from the White House. Fortu-
nately, time remains for the Clinton administration to fulfill its campaign promise
to achieve tough and meaningful environmental protection, including long over-due
pesticide reform. Otherwise, an historic opportunity — as well as the critical goal of
reducing human exposure to these most toxic of chemicals — may be lost.

Jay J. Vroom

Mr. Chairman, and Members of the subcommittee, on behalf of the member com-
panies of the National Agricultural Chemicals Association (NACA), I would like to
thank the subcommittee Tor the opportunity to comment on S. 2084 (the "Pesticide
Reform Act of 1994"), S. 2050 (the "Federal Insecticide, Fungicide, and Rodenticide
Act Amendments of 1994"), and S. 1478 (the "Food Quality Protection Act of 1994").
As you know, NACA is the not-for-profit trade organization of United States manu-
facturers, formulators and distributors of agricultural crop protection and pest con-
trol products. Our membership is composed of those companies which produce, dis-
tribute and sell virtually all of the active conipounds used in crop protection chemi-
cals registered for use in the United States. Clearly, NACA's members have a vital
interest in continuing to improve the processes which govern the testing, review,
and approval of their products. These comments discuss the improvements to the
present system which are truly needed, the consequences of not making those im-
provements, and how the specific proposals in S. 2084 and S. 2050 will, or will not,
result in overall improvement.

THE NEED FOR LEGISLATION

The current legislative debate exists because the science which supports pesticide
regulation has continued to evolve, while the laws and regulations governing pes-
ticides largely have not. At the root of this debate is the 1958 "Delaney" clause, an
anachronism which not only renders the FFDCA internally inconsistent, but also
conflicts with FIFRA, the primary statute under which pesticides are regulated.
NACA believes that there are two ways to resolve this inconsistency: Congress can
modernize the FFDCA by eliminating the Delaney clause (replacing it with a single
negligible risk standard for raw and processed food as recommended by the NAS
in their 1987 report 'The Delaney clause"), or EPA can modernize its policies which
implement the Delaney clause (including a affirmative ruling on "the NFPA" peti-
tion). Either option will largely avoid the disruption to America agriculture which
some have predicted if action is not taken.

This is not to say that other aspects of our pesticide laws could not benefit from
improvement. To the contrary, through the ongoing legislative debate several areas
of general agreement have emerged among EPA, the regulated community, and en-
vironmental activists.

Areas of agreement include:

• Delaney's "zero-risk" standard is no longer scientifically justified, is virtually
impossible to achieve, and should be replaced with a negligible risk standard.

• A single standard must be set for raw and processed food. Current law treats
them differently, and this makes neither scientific nor regulatory sense.

• Newer products, developed using state-of-the-art research and understanding,
must be brought more quickly to the market. NACA has worked closely and ef-
fectively with EPA to improve certainty in efficiency in data requirements, and
this process must continue.

• The administrative process for removing problem pesticides from the market
takes too long. We need a new process that can allow EPA to take action
cpiicker, while preserving essential due process rights.

• Re-registration is taking too long. The burden on EPA of reviewing mountains
of data is staggering, but the task is essential to public safety and confidence.
All parties have agreed that delays in this process serve no one, and real im-
provement must be found.

• Adverse effects from the loss of minor use pesticides are real, and growing. As
this subcommittee well understands, this issue must be addressed.

• The process for making routine improvements in pesticide usage, such as minor
label changes, could be improved.

WhUe these issues are important, the single issue which brings us together year
after year is repeal of the Delaney clause. If Congress cannot resolve that issue this
year, the job of implementing Delaney in the wake of the Les v. Reilly decision will
fall squarely upon EPA. As explained below, EPA has shown little willingness to re-
consider old policies, or to incorporate modem scientific principles into its Delaney-
implementation plans.

EPA APPEARS PREPARED TO PRESIDE OVER A REGULATORY "TRAIN WRECK"

One apparent consequence of the Les v. Reilly decision on Delaney policy is the
review, and possible revocation, of a number of valuable food use tolerances. Be-
cause EPA may no longer utilize a de minimis exception to the Delaney clause when
making tolerance decisions under the FFDCA, tolerances previously grated under
that exception must be reviewed to determine whether they violate a strict reading
of Delaney. However, rather than determining whether their preLes policies are still
justified (or legal), and rather than focusing on the ramifications of not reviewing
those policies, EPA has instead concentrated its efTorts entirely on obtaining a "leg-
islative solution." This blind focus on legislation unnecessarily places the entire bur-
den of reform on Congress. EPA should reevaluate what it can do to practically, and
legally, implement existing law. Without such a reevaluation, EPA will create confu-
sion, lose additional public confidence, and cause significant unnecessary disruption
to agriculture.

For instance, EPA has consistently interpreted the Les decision in the most ex-
pansive manner possible, claiming that the decision itself actually requires specific
regulatory actions, including the revocation of tolerances and cancellation of reg-
istrations. While denying that existing tolerances are a public health concern, EPA
has warned that without sweeping legislative reform it will be forced to revoke doz-
ens of needed tolerances, causing widespread disruption of agriculture, food process-
ing, and pesticide industries.

Yet EPA continues to overlook the plain language of other sections of the FFDCA
which would decrease the adverse effect of the Les decision on agriculture and the
America public. EPA also has failed to implement policy changes which would rec-
oncile agency practice with current law, and allow the Agency to focus scarce re-
sources on areas of true concern. Many now believe that EPA has deliberately cho-
sen to ignore these statutes and policies in order to create pressure for their many
legislative recommendations. This tactic will also allow EPA to avoid responsibility
when it begins to revoke large numbers of tolerances, and agricultural markets are
disrupted.

EPA claims it has two options: massive tolerance revocation, or their legislative
recommendations. In fact, there are at least six nonlegislative strategies to avoid
significant disruption, all consistent with current law:

Grant the "NFPA Petition." In the fall of 1992, the National Food Processors Asso-
ciation (NFPA) and others filed an administrative petition asking EPA to
(1) abandon its concentration and coordination policies (because they are illegal,
and amount to improperly promulgated regulations), and (2) recognize the "flow
through" provision of FFDCA §402. The petition was not published for comment
until February 1993. Although a response is not required by a specific date, nearly
2 years have now passed without EPA action. Ignoring comments on the petition
filed by hundreds of affected parties, assistant administrator Goldman glossed over
the importance of the petition in testimony before Congress on October 29, 1993,
stating that EPA was reluctant to break new ground administratively" with the
"interpretations" suggested by NFPA. This statement reflects a dangerous and un-
lawful unwillingness to consider proposals on nonlegislative solutions to the predica-
ment caused by the Delaney clause.

Rescind its Policy of Intentional Inaction. On April 6 of this year, EPA announced
via Federal Register notice that it had ceased review and processing of tolerance

petitions, as well as the associated FIFRA registration applications, if any of the
uses "appear" to result in a residue that needs a food additive regulation which
Delaney would bar. Without actually making a fact-based finding, EPA has arbitrar-
ily blacklisted products and completely disregarded the rights of registrants and the
needs of growers. Of course, the primary importance of this policy will be to slow,
if not stop outright, the introduction of several newer and possibly safer pesticides.
In so doing, EPA has illegally read the Delaney standard into both FIFRA and sec-
tion 408 of the FFDCA, and denied registrants the opportunity to adequately defend
their products before either the public or EPA.

Reconsider Outdated Policies. Many of the policies EPA has adopted in order to
implement FIFRA and FFDCA mandates include unrealistic, conservative assump-
tions and unnecessarily stringent definitions. In some cases, the policies lead to con-
tradictory results. For instance, many section 409 tolerances are required for foods
which are not commonly understood to be "processed." While EPA has proposed re-
designating dried hops as a raw food, it did so only after being required oy Congress
to do so in a appropriations bill. To date, EPA has failed to take similar action for
dried raisins and figs. Additionally, current EPA policy requires section 409 toler-
ances for many food byproducts, even if they represent only a small portion of the
food in a animal's diet. Although the law requires a tolerance only if the byproduct
"is a substantial source of nutrients in the diet of the animal," EPA requires a toler-
ance for all such byproducts, even though many are no longer used in animal feeds
{e.g., dried apple and grape pomace, and dried citrus pulp), or constitute only a in-
significant part of the animal's diet.

Other areas EPA has failed to address include (1) the "ready to eat" language of
FFDCA, which, if given effect, would lead to more realistic exposure and risk (and
therefore tolerance) assumptions, and (2) EPA's continuing focus on the theoretical
possibility of concentration rather than on actual data or residues. Challenges to all
of these outdated policies have been pending before EPA — ^unanswered — since at
least September of 1992.

Recognize Advances in the Understanding of Cancer. EPA's reliance on overly sim-
plistic category-based definitions of carcinogenicity fails to consider advances in sci-
entific understanding, unique properties of various compounds, and mechanisms of
action that may differ from one compound or test subject to another. Use of Maxi-
mum Toleratea Dose ("MTD") testing in regular protocol, and routine reliance on
exaggerated exposure assumptions leads to results which have no real world signifi-
cance, and are irrelevant to a determination of whether a compound "induces
cancer ... in man ... by tests which are appropriate for the evaluations of the
safety of food additives," and contribute to loss of consumer confidence in food safe-
ty. Other countries with modern scientific and regulatory systems no longer rely
solely on MTD.

Grant Hearings to Registrants Whose Compounds are Suspected of Violating the
Delaney clause. A announced last year the proposed revocation of the seven toler-
ances involved in the Les decision without first giving the registrants an opportunity
to present evidence on whether those residues did in fact concentrate above the level
of the raw product tolerance, or whether they "induce cancer" within the meaning
of the Delaney clause. Thereafter, the registrants filed requests for hearings, claim-
ing that their rights to supply data and make legal and lactual arguments against
revocation and been violated. On June 30, 1994, EPA denied those hearing requests.
Worse, EPA has also announced that it intends to revoke upwards of 70 additional
tolerances in the same manner, presumably without affording the registrants an op-
portunity to defend their products in an administrative hearing.

Revise the Current "section 18" Policy. EPA's first act implementing the Les deci-
sion was not against the tolerances named in that case. Instead, EPA moved against
the FIFRA section 18 "emergency" exemptions that farmers need to address unfore-
seen pest damage, for which alternative defenses often do not exist. On May 7,1993,
EPA revoked five existing section 18 tolerances, and denied applications for 16 oth-
ers because they "appear to meet" the Delaney clause "induces cancer" standard.
This action was taken without actual findings that the residues in fact "concentrate"
or "induce cancer" in violation of the Delaney clause, and without notice or oppor-
tunity for comment, as the FFDCA and the Administrative Procedure Act would re-
quire.

EPA acknowledged that its action would have an adverse impact on growers of
up to $70 million in 1993 alone. Those losses, and impacts such as product "black-
listing" and loss of needed, effective products could have been mitigated if EPA had
first (1) determined whether the residue actually violated the Delaney clause,
(2) resolved the tolerances at issue in Les, or (3) addressed the issues then still pend-
ing in the NFPA petition. Instead, EPA embarked upon a course designed to create

the need for their particular legislative agenda, even saying boldly at the time that
"The necessity of this [action] highlights tne need for new legislation that addresses
food safety. The Clinton administration will . . . develop a proposal." At that time,
at least two separate proposals were already pending before Congress.

EPA could easily extricate itself from the massive administrative challenges it
faces, avoid putting food production at risk, insure the public safety, and do so in
full compliance with existing law and regulations if it were to:

• Grant the NFPA petition. Current concentration and coordination policies are
illegal and no longer justified;

• Rescind its policy of intentional inaction.

• Abandon outdated policies (including definitions of "raw" and "processed" foods,
and implementing the "fiow-through" and "ready to eat" provisions of FFDCA),
and redefining what "induces cancer" means for purposes of the Delaney clause;

• Stop regulating on the basis of exaggerated risks and assumptions;

• Grant the hearing requests sought by the registrants in the "Les" and subse-
quent tolerance revocation actions; and

• Rescind the Current section 18 policy, or make it applicable to only those prod-
ucts which in fact are prohibited by Delaney.

NACA'S response to S. 2084 AND S. 2050

NACA well appreciates the time, efTort and attempts at inter-agency coordination
which have gone into development of the administration's FEFRA/Food Safety pro-
posal. However, by bringing omnibus new legislation to virtually every aspect of pes-
ticide regulation, the bills amount to a wholesale overhaul. Rarely will a system
which needs improvement be helped by adding layers and layers of untested new
authority. By failing to focus on the areas of true concern, these bills will have the
unintended affect of bringing the registration of new products (and the reregistra-
tion of existing products) to a halt, and they may not actually speed the removal
pesticides found subsequently to exceed society's acceptable risk-oenefit standard.
They will, however, clog EPA and the courts with citizen suits and other litigation,
and create confusion among EPA staff, the regulated community and public when
EPA attempts to act under one or more of the multitude of new authorities.

Nevertheless, NACA will address each of the major components of the two bills,
and explain why many of their provisions will not assist in the overall objective of
improving the system of pesticide regulation, or the safety of America's food.

FFDCA AMENDMENTS (S. 2084H

Risk Standard for Tolerances. Under the administration's proposal, a tolerance
may be established for a raw or processed food if the residue is "safe." Safety is then
defined as presenting "a reasonable certainty of no harm" when evaluating risks
from cancer, risks otner than cancer, and establishing tolerances for children and
other sub-populations. Because it would fundamentally alter the standard for evalu-
ating tolerances, the public deserves to understand precisely what this standard
means, how it will be interpreted, and what the net eiTect will be on individual ex-
isting tolerances.

For instance, the definition of "safe" was taken from a section of the Code of Fed-
eral Regulations dealing with food additives. However, there is language in that def-
inition which acknowledges that "intended conditions of use" are relevant, and that
it is "impossible to establish with complete certainty the absolute harmlessness of
the use of any substance." NACA is curious why the entire definition was not taken.
Furthermore, the plain language of the phrase "no harm" appears to establish a
zero-risk standard. If so, this bill merely replaces the Delaney clause with another
"zero-risk" standard. While we appreciate that EPA has proposed replacing the
Delaney clause with a single risk standard, NACA is very concerned with what this
new standard means, and how it will be interpreted.

Finally, as this subcommittee knows, the current system for setting and maintain-
ing tolerances is a "health-based" system. Consequently, the administration's in-
creasingly vocal pleas for a "health-based" system are patently misleading. Pes-
ticides are among the most heavily researched and regulated products on the mar-
ket today. Before a pesticide may be registered for use, manufacturers must perform
over 120 tests designed to protect human health and the environment. The registra-
tion standard requires protection of "human health," and pesticide tolerances are
NOT set at particular levels in order to provide agricultural benefits. Although im-
provements are always welcomed (and have been continuously added under current
law), we have a strong health-based system in place today.

Elimination of Benefits Consideration. Although the administration has never ex-
plained why limited consideration of benefits poses a public health concern, its bills
preclude consideration of pesticide benefits when establishing tolerances and in reg-
ulating pesticide use. Although an extension of time for an existing tolerance may
technically be grated using benefits, that extension would be virtually impossible to
obtain. For instance, the registrant would have to show that loss of that particular
tolerance would "severely disrupt domestic food production." Rarely, if ever, would
loss of one product tolerance create a nationwide disruption. But over time, this pro-
vision coula severely affect agriculture through the attrition of "a thousand paper
cuts" which together would oe devastating. Furthermore, proposals on so-called
"label call-in" and "phase-down/phase-out" would eliminate consideration of pesticide
benefits altogether.

Lost in botn bills is the concept that decisions regarding risk cannot be accurately
made without also evaluating tne benefit which acceptance of that risk provides. A
detailed consideration of benefits — which comes into play only when test results are
very close to the safety standard — allows EPA to make informed decisions. After all,
blind reliance on numbers alone is responsible for the Delanev dilemma we face
now. Congressional debate concerning the value of a cost-benefit analysis in other
legislation this year has shown that it is an extremely important undertaking.

Overly Restrictive Standards for Children and Sub-populations. Last summer's
NAS report made several basic recommendations, including that more/better data
be developed on pesticide use and on the foods children eat; that additional toxicity
testing procedures be developed which evaluate the vulnerability of infants and chil-
dren; and that improvements be made in the risk assessment process. NACA largely
agrees with these recommendations, as does the 220-member Food Chain Coalition
through the legislation which they support.

However, in subtle but important ways this bill goes beyond the recommendations
of the NAS. For instance, the NAS recommended an additional 10-fold safety factor
for infants and children for those instances where "there is evidence of postnatal
developmental toxicity, and . . . data from toxicity testing relative to children are
incomplete." By contrast, this bill requires the additional safety factor as a matter
of course. The NAS report also did not suggest that EPA be required to make spe-
cific "findings" that tolerances are "fully protective" of infants and children. We
question whether such a determination could actually be made, and fear that it will
unnecessarily slow the review and approval processes without providing real, added
protection, because EPA will be hesitant to certify that a tolerance is indeed "fully"
protective.

Rather than first evaluating which of the NAS recommendations are already
being done, which may be correct in concept but need more evaluation, whether
methods exist to carry out the particular recommendations, and whether each rec-
ommendation provides added benefit or protection for the cost, EPA simply put the
recommendations into legislative language. Although NACA understands EPA's de-
sire to be responsive, blindly fixing each recommendation in legislation is dangerous
because (as with the Delaney clause) it will prohibit EPA from adapting to changes
in scientific understanding.

Exaggerated Exposure Assumptions. By requiring use of exaggerated exposure as-
sumptions (100 percent of fooa contains residues at the tolerance level every day
for a lifetime), EPA guarantees that its risk estimates will be vastly overstated. Al-
though tolerances are set at the maximum use pattern (percent of crop, full label
rate, etc.), this does not always result in residues at the tolerance level. Thus, these
exposure assumptions would negate the use of actual or average residues, which
have long been agreed to by almost everyone who has dealt with this issue. The ad-
ministration's obsession with ultra-conservatism grossly overstates exposure, and
makes no scientific sense.

Separate Tolerances. This bill allows EPA to establish separate tolerances for resi-
dues at any point in the food production chain. This new concept was merely alluded
to in earlier testimony on the bill, and the language of the bill raises more questions
than it answers. For instance, under what conditions and/or for what food forms
would separate tolerances be required? Would separate tolerances be required for
the same food at different stages in the distribution chain? What new or additional
residue testing requirements would exist? And importantly, how will FDA conduct
(and pay for) enforcement? Until these questions are adequately debated and an-
swered, NACA believes this provision is premature.

No Uniform National Tolerances. This legislation fails to provide for national uni-
formity of tolerances. Without such uniformity, the varying laws of State and local
governments will place an unfair burden on agriculture, food processing and trans-
portation industries.

Tolerances for All Inert Ingredients and Metabolites. While failing to so acknowl-
edge in previous testimony, the administration's bill wiU require a separate toler-
ance for each and every inert ingredient and metabolite in a pesticide product, re-
gardless of toxicity. Under current law, EPA may chose to require a tolerance if the
inert ingredient or metabolite presents a risk meriting such regulatory action.
S. 2084 will require registrants to undertake massive additional testing and data
development, and the data review will exhaust years of EPA staff time. By focusing
scarce resources on real risk, the current system makes infinitely more sense.

Tolerance Reevaluation. This proposal requires EPA to review literally hundreds
of existing tolerances and exemptions within 180 days, ad identify those which do
not appear to meet the new standards. To maintain an "apparently unacceptable"
tolerance, registrants would be required to submit data within 2 years; within 3
years EPA must make a fmal decision on 75 percent of those tolerances, and within
4 years for the remaining tolerances. Tolerances and exemptions which do not meet
the new standard will be revoked.

In addition to the administrative burden, it is not at all clear how this new au-
thority will relate to the reregistration program. Since EPA is currently making
similar evaluations in that context, this additional authority is redundant. NACA
members have already invested approximately $100 million dollars, and EPA has
worked very hard to make reregistration a success. Failure to coordinate these ef-
forts would be a shameful waste of both money and time. If tolerance reevaluation
is not being adequately addressed through reregistration, then the solution is to fix
that process, rather than creating a rival program in mid-stream.

Further, the task which EPA proposes is enormous, the deadlines strict, and the
consequences (revocation) are severe. We believe EPA's self-imposed deadlines are
unrealistic.

Unless EPA proposes to give the data only a cursory review, or adhere to a rigid
numerical standard to determine whether a tolerance is safe, sufficient time simply
does not exist to adequately analyze the data. We are also concerned that regulatory
action (and "listing") will be initiated on what amounts to no more than whim. The
proposed "appears to meet" standard is virtually unprecedented in its vagueness.
SufTicient time will not exist in the 180 days following passage of the bill to set the
standards and actually accomplish a review of all current tolerances and exemp-
tions.

FIFRA AMENDMENTS (S. 2050)

Phase-Out / Phase-Down. Under this extraordinary new authority, EPA niay re-
strict, reduce or eliminate the use or production of a pesticide if "credible scientific
evidence indicates that use of the pesticide is reasonably likely to pose a significant
risk to humans or the environment." The standard used in this section is vague, and
the consequence of EPA action severe. For instance, does the "credible scientific evi-
dence" trigger mean "some" evidence, or a preponderance of the evidence? What if
that evidence was disputed by other "credilole" evidence? Must "credible" evidence
be peer-reviewed? These important questions are left unanswered in the legislation.

Other definitions which are unworkably vague are "reasonably likely to pose" and
"significant risk." By "reasonably likely" does EPA mean any amount greater than
50 percent? By "significant risk" does EPA intend something less than or more than
would be required to sustain a cancellation action? NACA also is concerned that the
"use" of the pesticide which leads to risk does not contemplate that phase-out/phase-
down would only apply when the pesticide was not being used "in accordance with
widespread and commonly recognized practice" as is currently required under
FIFRA.

This authority is also redundant with both current and proposed new authorities.
For instance, if EPA discovered a new risk, why would existing cancellation and/
or suspension authorities not suffice? If cancellation or suspension are inadequate,
why not amend them? Regarding the proposed new authorities, it is unclear when
EPA would choose to proceed with a data call-in, label call-in, phase-out/phase-
down, prescription use, cancellation, or suspension authorities.

In a final irony, this legislation expressly prohibits common-sense application of
the phase-out/phase-down authority. This bill prohibits EPA from taking into ac-
count differences between various classes of pesticides, differences in environmental
risk, and differences between agricultural and nonagricultural pesticides. At a time
when the entire production of a pesticide could be eliminated, these considerations
are extremely important. Because it ignores the significant investment of time and
money which registrants make in their products, tramples the fundamental due
process rights necessary to challenge unfounded government action, and denies a

company the ability to legally produce basic chemicals — possibly for other uses —
NACA strongly opposes this provision of the bill.

Cancellation Procedures. Under S. 2050, FEFRA's current formal cancellation pro-
cedures would be replaced by informal rulemaking, a process which provides none
of the procedural protection necessary to adequately defend a product's registration.
Whereas the cancellation process under current law allows an adversely afTected
party to request an adjudicatory hearing (involving an opportunity to present testi-
mony and cross examine witnesses before an impartial decisionmsQcer), the informal
rule making proposed here is little more than the familiar "notice and comment"
process.

In the past, EPA has argued that disregarding these procedural protections is jus-
tified because the formal hearing process is "too burdensome." However, since 1980,
EPA has issued approximately 40 cancellation notices under FIFRA, and a hearing
with cross examination was requested in only three of those proceedings. Testimony
in those hearings averaged only 21 days. Although S. 2050 does allow an affected
party to request an informal hearing, EPA may decline to hold the hearing. If held,
the hearing would not allow for cross examination or other procedures which pro-
vide important due process rights. As such, the protection offered is inadequate to
a full and fair evaluation of agency action.

In addition, the burden of proof in a cancellation proceeding is inexplicably shifted
from the challenger to the registrant, who must show why a cancellation should not
go forward. This turns the concept of fundamental fairness on its head. Once EPA
has granted a registration, having reviewed all required data, it is only fair that
the party initiating a cancellation should have the burden of showing the standard
for cancellation has been met.

Finally, this bill changes the standard for challenging agency action in court from
whether the action is supported by "substantial evidence" to whether the action was
"arbitrary and capricious." Particularly when combined with the inability to enter
testimony and examine witnesses, this change is significant. By stacking the deck
entirely in favor of the Agency, EPA has effectively eliminated a registrant's ability
to defend its products.

To the degree data show that current procedures-are inadequate or do not protect
the public health, NACA has been willing to support improvements. However, the
wholesale revisions contained in this bill have stripped all that is fair from the proc-
ess, making a cancellation under this process a fait accompli. For those reasons,
NACA opposes them.

Suspension by Order. Similar to the proposed cancellation language, S. 2050
would replace current suspension procedures with "suspension by order." In short,
this proposed process eliminates the expedited hearing (including the opportunity to
present evidence and examine witnesses on the record), allows EPA to proceed with-
out simultaneously filing a notice of intent to cancel, and lowers the standard for
challenging agency action from "substantial evidence" to "arbitrary and capricious."

Particularly in light of the proposed cancellation amendments, NACA questions
the need for such drastic change. If cancellation is expedited, what value is there
to changing suspension? Since 1972, EPA has suspended the registration of only five
pesticides. One explanation why suspension may not have been used more often is
that improved registration requirements, reregistration, and existing cancellation
and other regulatory authorities have avoided pesticide emergencies and "imminent
hazards." EPA should first be required to show how current law has failed to protect
the public health, and specifically, how current suspension authority is inadequate.
This is especially true, since FIFRA amendments in 1988 were designed specifically
to address weaknesses in EPA's ability to use its suspension authority. If defi-
ciencies remain, then they should be fixed in a manner wnich is tailored to address-
ing a particular need. Rather than seeking specific improvements, the cancellation
and suspension provisions oflered under S. 2050 abandon virtually all of the con-
cepts of fairness in current law, in favor of a process which focuses only on adminis-
trative expediency for the Agency.

Label Call-In. In testimony before Congress last September (and when soliciting
support for its proposal), EPA cast its label call-in proposal in terms of "relatively
small changes" such as "additional warning statements." However, when reduced to
legislative language, the proposal encompassed wholesale changes in labeling, pack-
aging and even composition of a pesticide. Under S. 2050, EPA is authorized to
order such changes ii the Administrator "determines that the risks associated with
the use of a pesticide can be reduced." The only limitation on EPA's authority would
be if the change effectively prohibits or makes economically unfeasible substantially
all use of the pesticide on one or more use sites.

The concepts of "cost" or corresponding "benefit" have not been linked to the par-
ticular risk reduction effort. (The only mention of cost is to "society" at large, which
is meaningless in the context of specific agency action.) For instance, assume that
EPA determines that risk could be reduced by eliminating aerial application or by
a difierent type of formulation. Would not the cost of such changes, and the amount
of benefit from the changes, be relevant considerations? By failing to include these,
or some form of "least burdensome" requirement, the administration has given itself
unnecessarily broad authority and placed an unnecessary burden on registrants,
users and dealers, and the public at large. "

Registration Renewal ("Sunset"). S. 2050 recasts FIFRA's current reregistration
program as a system where pesticide registrations must be reviewed and renewed
every 15 years. To accomplish this, registrations would be divided into three cat-
egories: pre-1984, post- 1984, and postamendments. Each category would have stag-
gered deadlines for EPA to complete its review. By the deadline, EPA must let the
registration expire because the application is incomplete or supported by insufiicient
information, renew the registration, or initiate a cancellation proceeding. If EPA
fails to act within the prescribed timeframe, the registration may receive an exten-
sion of one additional year. Fees paid by registrants would support this program.
While NACA understands that some type oi periodic review makes common sense,
we have fundamental concerns the content, structure and scope of this proposal.
First and foremost, we believe that any successful review or renewal effort must be
built on first completing the existing reregistration program. Once that program is
complete or substantially complete, all interested parties should review the program
shortcomings, to avoid repeating any of the initial program mistakes. The rereg-
istration has already taugnt that (1) there must be certainty, at the beginning, on
what constitutes a complete data package, (2) EPA must be realistic in the time it
takes and allows the registrant to develop the required data, and (3) EPA must
allow itself sufficient time and resources to analyze that data properly. This pro-
posal learns from none of those lessons. By setting strict deadlines in legislation,
without first estimating which or how much data will be required or submitted, or
the time and resources necessary to review that data, EPA is setting itself up for
failure and fiber loss of public confidence. Because of the strict, possibly unrealistic
deadlines, product registrations which actually meet the existing standards will be
put at unnecessary risk.

We also fail to see how this process coordinates with timetables and existing or
proposed authorities regarding tolerance decisions. Without careful coordination, tol-
erance and registration decisions will not be consistently reviewed, resulting in
wasted time, money and eflbrt. Without careful coordination and honest evaluation
of the ongoing reregistration program, this proposal threatens to disrupt public con-
fidence, and what is universally recognized as the safest, most efficient and produc-
tive food safety and production system in the world.

Reduced Risk Pesticides. S. 2050 directs EPA to develop criteria for designating
a pesticide as "reduced risk." Registration applications which meet the criteria
would be eligible for priority review, and if other conditions are met, would receive
two additional years of exclusive use of data. That this provision even exists is proof
that it takes too long to bring new pesticide products to market. It is unacceptable
that even simple applications can take over 2 years after all necessary data has
been submitted. If all applications were reviewed and acted upon with reasonable
speed, "priority review" would not be necessary. NACA would prefer that EPA find
ways to speed the existing registration system, rather than speeding the system
only as a '^onus."

On its face, this provision has certain appeal because the public wants (and EPA
would be able to claim it is approving) "safer" pesticides. We ask "safer than what?"
If all products registered are indeed "safe" (having submitted data and "passed"
some 120 difierent tests required under FIFRA) this bill establishes a two tier sys-
tem. Rather than increasing public confidence, this provision will actually increase
public fear, because (if the program is successful) the number of "safer" pesticides
will always be fewer than the other" pesticides. Importantly, this bill also fails to
recognize that once registered under FIFRA, all pesticides have shown themselves
to be "safe."

We also question whether it is truly possible to develop criteria which fairly deter-
mine which pesticide is "safer" than another. Will safety be judged to the applicator
or consumer/ Is one form of application "safer" than another? What about pesticides
which clearly decrease the risK in one area, but arguably increase risk in another?
We raise these questions because we know how difficult it will be for EPA to fairly
develop criteria and administer the program. There is no question that we all want
"safer pesticides. The only question is how to develop and bring them to market.

20-127 O - gs - ^

New products and technologies, and those currently "in the pipeline," prove that the
market is already quickly moving in that direction. However, until we understand
what standards and criteria EPA intends to use to implement this program, and
until more experience is gained through EPA's current 'pilot program," we believe
that legislation on this subject would be premature.

Fees. In addition to the fees imposed for tolerance review and approval activities
under S. 2084, S. 2050 imposes at least five new user fees. New fees are assessed
for registration renewal (sunset"), exports, new supplemental reregistration fees
(except for biological pesticides and minor uses), an extension of the annual mainte-
nance fees, and a new fee on pesticides eligible for reregistration.

NACA is sympathetic to the resource demands upon EPA. However, in spite of
repeated requests for an accounting of the millions of dollars already paid to support
reregistration, EPA has failed to provide any such document or report. Nevertheless,
NACA member companies have continued to honor the fee structures put in place
through FIFRA '88 and its amendments. It is most disturbing that there is no evi-
dence in this legislation, or in testimony to date, that the administration has made
even a token effort to estimate how much any of these new programs and authori-
ties will cost. In fairness, registrants cannot be expected to come to the table with
a blank check, and receive no guarantee that their investment is sufficient, or is
being well managed. As new sources of revenue are discussed, industry and govern-
ment alike must nonestly address the cost to fully find existing programs, the addi-
tional cost to find new programs, and then carefully evaluate the incremental bene-
fits derived from that added cost.

Prescription Use. For pesticides classified under the "restricted use" provisions,
S. 2050 would allow EPA to impose a condition that the pesticide be applied only
by prescription. While the goals behind the provision are worthy of discussion,
NACA douDts that sufficient structures are currently in place to ensure that such
a system could currently be administered fairly and efTectively, and without signifi-
cant disruption of agricultural practices. Adequate statutory guidance (absent in
this proposal), and available and affordable commercial services are absolute pre-
requisites to a workable prescription use plan. At present, this proposal is at best
premature.

Citizen Suits. S. 2050 would authorize any person (with or without a financial in-
terest in the matter) to bring suit in Federal Court against EPA, a pesticide reg-
istrant, or any pesticide user except for certain agricultural producers engaged in
production, for any alleged violation of FIFRA or any EPA pesticide regulatory re-
Quirement. However, a citizen may make a request (not subject to judicial review)
tnat the Administrator or a State, take action against a producer. Provisions exist
for the payment of attorney fees, expert witness fees, and litigation costs to any
party wno "substantially prevails." NACA believes that this is an invitation for
gridlock. We fail to see how this provision is consistent with the administration's
goals of reinventing government, or of forging a partnership with the regulated com-
munity.

Civil and Criminal Penalties. Current civil penalties for registrants, commercial
applicators and distributors of $5,000 per violation are increased under S. 2050 by
500 percent, to $25,000 per day, up to a maximum of $400,000. Furthermore, the
current warning requirement prior to imposition of a fine has been eliminated. For
criminal penalties, current law provides or fines (maximum of $25,000) and jail
(maximum 1 year) for knowing violations by registrants, commercial applicators and
distributors. S. 2050 not only increases the fines (to $50,000), but also makes them

fier day, and allows for double fines for second violations. Jail time is also increased
rom 1 year to 5 years. However, by far the most troubling aspect is that the stand-
ard for any violation of FIFRA has changed from a knowing violation to merely a
negligent violation.

NACA agrees that EPA should have strong, meaningful authority to punish inten-
tional violators, as well as repeat offenders. But we question, on grounds of fun-
damental fairness, whether such unprecedented, stringent authority (particularly as
applied to smaller, commercial applicators or dealers) is necessary to deter neg-
ligence. The proposed scheme establishes virtual strict liability, with severe pen-
alties. We wonder if improved training and education are not better approaches to
decreasing actual risk and protecting the environment. This approach is also more
consistent with the administration's goal of reducing pollution at its source. This
proposal, on the other hand, is clearly designed for its punitive effect.

Inspection and Record Keeping. Under current law, EPA has authority to require
pesticide producers to maintain certain records (FIFRA Sec. 8), and to inspect estab-
lishments where pesticides are held for sale or distribution (FEFRA section 9).
S. 2050 expands both authorities, to require and inspect records of distributors, pes-

ticide testing facilities, commercial applicators. EPA would also have new authority
to inspect pesticide user premises ana pesticide testing facilities. Inspection of pri-
vate residences and farms would be limited to instances of "suspected violations."
In addition, EPA would have the authority to require record keeping for all agricul-
tural pesticide use.

Of these provisions, and many other not listed, NACA is most concerned about
inspection of private residences without a warrant. If a "suspected violation" is
enough to initiate a search, and refusal (even on good faith grounds) to consent to
a search constitutes a separate violation, it is not difficult to imagine that an anony-
mous complaint (whether founded or not) could lead to $25,000 or more in penalties
against a farmer who refuses to consent to a warrantless search. We believe the ad-
ministration's proposal is rife with such possibilities, and represents a dangerous in-
cursion into the privacy and personal liberty of its citizens.

Nevertheless, NACA understands, and has no objection to the administration's de-
sire to encourage safe production and use of pesticide products. We believe that a
system where everyone adheres to the highest level of professionalism serves the
regulated community, the regulators, and the public. However, when seen in light
of the new civil and criminal penalties (particularly for negligent violations), these
requirements are ominous. As with the penalty provisions, a system which educates
and rewards compliance would be infinitely preferable.

Exports. Under new regulations put in place during this administration, any pes-
ticide made in the United States (including unregistered pesticides) may be exported
as long as it is labeled in accordance with EPA regulations and the exporter receives
from the foreign purchaser a written acknowledgement of the pesticide's unregis-
tered status. Under S. 2050, export of pesticides banned for use in the United States
would be prohibited, subject to two narrow exceptions. As we have testified repeat-
edly in the past (and will elaborate on if you desire), we believe that current law
is working well, that these restrictions are unwarranted, and that further restric-
tions will drive jobs, production and research out of the United States.

Further, the proposal to raise $4 million through a find which amounts to an ex-
port tax for foreign technical assistance programs is simply a bad idea. To our
knowledge, no other country taxes its own exports — for any reason. Further, these
programs would be largely redundant, duplicating many of the product stewardship
efforts already in place and/or in development by many NACA member companies.

Conclusion

Mr. Chairman, we sincerely wish we could tell you that this bill could easily be
fixed. It cannot. By creating too many new authorities with vague and ambiguous
standards and triggers, failing to coordinate with existing authority, and generally
operating without adequate due process protection, NACA cannot ofTer its support.
As we have said repeatedly in the past, NACA does stand ready to work with this
committee and any other interestea party. We believe that starting with S. 1478,
a bill with the support of 22 cosponsors, ofiers the best possibility Tor real reform.

Philip J. Landrigan

Mr. Chairman, and Members of the subcommittee, my name is Philip J.
Landrigan, M.D., M.Sc. I am professor and chair of the Department of Community
Medicine and director of the Division of Environmental ana Occupational Medicine
of the Mount Sinai School of Medicine in New York City. Also I am a pediatrician
and professor of Pediatrics at the Mount Sinai School of Medicine. Formerly I was
a member and then the chair of the Committee on Environmental Hands of the
American Academy of Pediatrics.

From 1988 through 1993, I was the chair of the National Research Council (NRC)
Committee on Pesticides in the Diets of Infants and Children. This committee
issued its final report in June 1993, and at the time of release of that report I and
other members of our committee had the honor to present testimony describing our
findings and recommendations before the Full Senate Committee on Agriculture. I
have also collaborated with more than 30 pediatricians, public health specialists and
other physicians convened-by Physicians for Social Responsibility to develop and
support legislation to implement the recommendations of the NRC report.

I am pleased to appear before you today to discuss issues relating to the reform
of pesticide policy in the United States. As a pediatrician, I believe that the subject
of this legislation is of great significance to the health of all of America's children.
The NRC Pesticide Report

Last year's NliC study concluded that the Federal Government's decisionmaking
process for regulating pesticides in the diet does not pay sufficient attention to the

protection of human health, especially the health of infants and children. The Gov-
ernment's current pesticide regulatory program takes a one-size-fits-all approach. It
ignores the great diversity in diet that exists among people of different age groups,
and fails to take cognizance of the fact that children diner greatly from adults not
only in their size but also in their metabolism and in what they eat.

A fundamental tenet of pediatric medicine is that children are not just little
adults. They are in many respects truly different. Unfortunately, current pesticide
regulation in the United States does not adequately reflect that understanding. To-
day's regulatory system does not specifically consider variations in pesticide expo-
sure between adults and children. Neither does it consider the ways in which chil-
dren's bodies may react differently to foreign substances.

To better protect the health of infants and children, the NRG report recommended
that the Federal Government change some of its scientific and regulatory procedures
for limiting pesticide residues in children's diets. It also recommended that the regu-
latory agencies adopt a new method of risk assessment to more accurately gauge
the population at risk. And it urges that toxicity testing of pesticides be more com-
prehensive.

The goal of our report was to make the very good food supply of the United States
even better. We dia not say that parents should radically change their children's
diets to avoid certain foods. On the contrary, parents should continue to emphasize
fruits and vegetables in their children's diets. Nonetheless, basic changes are needed
in the current regulatory system to ensure that foods eaten by infants and children
are safe.

Tolerances — the levels of pesticide residues legally allowed on or in foods when
they leave the farm — constitute the only mechanism for regulating pesticide resi-
dues in foods. Thus our committee recommended that the Government have as its
clear goal the setting of tolerances that more fully protect human health, including
the health of infants and children.

Children tend to eat fewer kinds of foods as compared to adults and they consume
more of certain foods per unit of body weight. In addition, they drink more water,
both alone and mixed with other foods. For example, children under the age of 6
months consume 7 times more water pound per pound of body weight than do
adults. The current regulatory system aoes not consider these dilTerences. Neither
does it do a good job oi considering the differences in diets between children of dif-
ferent ages, ethnic backgrounds, and regions of the country.

The NRC Committee suggested a new approach to pesticide risk assessment and
thus to tolerance setting that would look at the diets of infants and children sepa-
rately from those of adults. Current risk assessments use a single number to rep-
resent the average exposure to pesticides of the entire American population. But
this method overlooks children on both ends of the spectrum — those who receive
above-average exposure as well as those who receive below-average exposures. We
recommended, instead, a statistical technique that combines data on the kinds and

?[uantities of foods eaten by children with data on the pesticide residues on those
oods. This combined analysis would help regulators determine actual exposure lev-
els is for children in a variety of circumstances, rather than looking only at average
exposure. It would provide a rational basis for setting more effective tolerance lev-
els.

The NRC Committee noted that a major obstacle to the use of this new approach
is a lack of data in certain areas. Clearly, more accurate risk assessments will not
be forthcoming without better information on food consumption patterns, pesticide
residues, and toxicity. Specifically, the NRC Committee recommended that measure-
ments of pesticide residues in foodstuffs should be standardized across the Nation
and computerized. These measurements need to reflect foods eaten by children, the
different rates and methods of pesticide applications and the effects of food process-
ing on pesticide application, and the effects of food processing on pesticide con-
centrations.

The NRC Committee recommended that regulators must take into account chil-
dren's exposure to pesticides from nondietary sources. Water, air, soil, lawns, and
indoor surfaces all must be considered as potential sources of exposure.

The NRC Committee urged regulators to recognize that children may be exposed
to multiple pesticides with common toxic effects. The NRC report recommended that
EPA treat pesticides that are pharmacologically related or have a common toxic
mechanism or eflect as being additive in their action in the absence of evidence to
the contrary.

The NRC Committee recommended that toxicity testing procedures should be de-
veloped that specifically evaluate the vulnerability of children. Of particular impor-
tance are tests for toxicity to the developing immune, nervous, and reproductive sys-
tems.

The NEC report recommended that there should be a presumption of greater sus-
ceptibility of infants and children in the absence of evidence to the contrary- Cur-
rently u animal tests show no adverse efiects for a pesticide at a certain expo-
sure level, then the level that is thought to be safe is determined by dividmg that
no-effect level by 100. This accounts for differences between humans and animals
as well as variation among humans. EPA then divides this number again by 10 if
studies have shown effects on the developing fetus. The NRC report recommended
use of an additional 10-fold safety factor to account for differences between adults

and children. , , , . r ^■ • i r

Finally, the NRC Committee recommended that estimates of disease nsk from
pesticides' take into account changes in exposure and susceptibility that occur
throughout a person's life. Children who are exposed to a carcinogen early in life
have many more years of life ahead of them than do adults to manifest a cancer
or other chronic illness that may be triggered by early exposure. Risk assessment
procedures and the standard setting process need to take cognizance of thisbiologi-
cal difference. This difference constitutes an further rationale for the NKC rec-
ommendation of an additional 10-fold safety factor.

THE ADMINISTRATION PROPOSAL

Overall, the administration's pesticide reform proposal is well intentioned and in-
corporates many of the recommendations of the NRC Committee, but lacks kev de-
tail. The adininistration's general emphasis upon the special sensitivity of children
to pesticide residues is overdue. Elements of the administration's proposal are wor-
thy of specific praise. Thus, the administration proposal for better data collection
on foods infants and children eat, pesticide residues in those foods and for paying
attention to differences in sensitivity to these residues, will enhance our under-
standing of the full range of toxic effects of pesticides. Also the administration s call
for wider application ofhealth standards to raw and unprocessed food and expand-
ing food safety testing from the farm gate through the retail level will be very use-

f I

In at least three specific areas, however, the administration proposal makes note
of, but fails to fully implement the recommendations of the NRC Committee. In each
of these important areas— standard setting, multiple exposures and specific testing
protocols— the administration's good intentions are undermined by excess discretion
or by a willingness to allow a lack of information to perpetuate unnecessary expo-
sures of children to pesticides. In each area, applying a more protective presumption
against continued pesticide exposures would more accurately reflect the preventive
public health recommendations of the NRC Committee and more effectively reform
Federal pesticide policy.

STANDARD SETTING

Acknowledging the particular vulnerability of infants and children to pesticides,
the administration proposal includes up to an additional 10-fold margin of safety for
pesticide residues. Superficially, this provision would appear to implement the rec-
ommendation of the NRC Committee. But the administration proposal merely sug-
gests that the additional 10-fold margin of safety "take into account ... the c^
pleteness of the data with respect to infants and children." By contrast, the NRC
more explicitly prescribed the additional margin of safety "when data from toxicity
testing are incomplete." The administration proposal should specify that the addi-
tional margin of safety shall be applied, unless there exists evidence that it is un-
necessary.

MULTIPLE EXPOSURES

The administration proposal notes that EPA "shall fully account for available in-
formation on the cumulative effect of such residue and any chemically or pharma-
cologically related substances in the human diet, and other ways in which the
consumer may be exposed to such residues . . . including, to the extent data per-
mit, throu^ drinking water." More specifically, the proposal would require EPA to
"assess the risk of the pesticide chemical residue based on . . . available informa-
tion concerning the cumulative effects on infants and children of such residues and
other substances Uiat have common mechanisms of toxicity."

Although appearing to satisfy the NRC recommendation, this component of the
administration proposal falls short because it would continue to allow a pesticide
the benefit of the doubt if toxicity testing for combined action has not been under-
taken. To fully implement the NRC recommendation, the administration proposal
should prevent unnecessary childhood exposure to pesticide residues by requiring
EPA to treat pesticides that are pharmacologically related or have a common toxic

mechanism or effect as having an additive deleterious effect, in the absence of evi-
dence to the contrary. This provision — omitted from the administration proposal —
would implement the NRC recommendation that in the absence of data to tne con-
trary, there should be a presumption of greater toxicity to infants and children.

CHILD-SPECIFIC TESTING PROTOCOLS

Although the administration's proposal seeks additional data on the effects of pes-
ticides on children, it requires no specific protocols for tests to assess whether a pes-
ticide poses particular risks to children. The administration proposal would require
collection of additional data only for general determinations of whether a pesticide
might compromise the "soecial vulnerabilities of children and other sensitive popu-
lations." By contrast, the NRC Committee endorsed more ambitious testing protocols
to better protect children from unnecessary pesticide exposures. Legislation should
require EPA to develop protocols for tests that would specifically determine whether
a pesticide poses particular risks to infants and children. This provision — omitted
in the administration proposal — would ensure that pesticide data submitted to EPA
satisfy children-specific safety requirements.

Summary

In summary, children deserve special consideration when it comes to pesticide
regulation. By including some of the specific recommendations outlined in the NRC
report, the administration pesticide reform proposal would advance our understand-
ing of the risks infants and children face from pesticide residues. In several impor-
tant respects, however, the administration proposal — while echoing the language of
the NAS report — would not ensure that the report's recommendations would be fully
adopted. By more firmly implementing the NRC's recommendation of a protective
presumption against continued exposure to pesticide residues, the administration
and Congress could do much to ensure that children's health is not compromised
and that America's future is conserved.

Mr. Chairman, I shall be pleased to answer any questions.

Stephen A- Ziller

Mr. Chairman, and Members of the subcommittee, I am Stephen Ziller, the vice
president for Science and Technology of the Grocery Manufacturers of America
(GMA). I am appearing today on behalf of GMA to testify on Federal regulation of
pesticides that are used in the production of food.

GMA is an 85-year-old national trade association comprised of over 130 companies
which manufacture food and other products sold in retail stores throughout the
United States. Member companies employ over 2.5 million people nationwide and
have annual sales in excess of $360 billion. Our members produce more than 85 per-
cent of the packaged food sold at retail in the United States.

For almost two decades, GMA has supported the concept of revising the statutory
provisions governing Federal regulation of pesticides used in the production of food.
That support has, of course, been conditioned upon new legislative provisions that
would strike an appropriate balance between preserving an abundant and whole-
some food supply and protecting against unsafe pesticide residues.

An unusually large member of bills are now pending before Congress that would
change the way that EPA and FDA regulate pesticides. Rather than address any
particular bill, my testimony will deal with ten general principles that GMA be-
lieves are essential to any successful legislative approach to revise the current stat-
utes relating to Federal regulation of pesticide residues in food. GMA is committed
to support legislation that embodies these principles, and we will oppose legislation
that fails to reflect these principles.

1. National Uniformity. It is essential that any new legislation establish a single
national policy for the regulation of pesticides used in food production. We cannot
tolerate a system under which each oi 50 different States can have its own separate
requirements. The food industry cannot market 50 different products in this coun-
try, one for each State. Without national uniformity, no legislation relating to pes-
ticide residues in food can be acceptable to GMA and its members.

2. Safety of Pesticides. New legislation should require pesticide tolerances to be
established at a level that will adequately protect the public health. For a carcino-
gen, we support the use of reasonable risk assessment procedures to assure that
there is a negligible risk. Human exposure assessments should be based on actual
data whenever possible, and where such data are lacking on the basis of reasonable

assumptions. It is inappropriate and scientifically unacceptable to establish detailed
rules for safety assessment in legislation, because science changes so quickly that
the legislation simply cannot keep up with it. EPA must be entrusted to use the
best available safety assessment procedures as they are developed and become ac-
cepted within the scientific community. Arbitrary and rigid rules, such as speciiic
safety factors, frozen into law, are incompatible with sound scientific decisions.

3 Benents of Pesticides. Any new legislation must reflect the fact that pesticides
olav'a major role in the production of a safe and wholesome food supply and thus
provide substantial benefits to the American public. Pesticides contrd disease and
preserve an adequate and affordable food supply. It is therefore important that any
new legislation reflect these important benefits.

4 Periodic Review of Pesticide Tolerances. GMA has no objection to the periodic
review of pesticide tolerances, to assure that the tolerances continue to reflect ade-
quate protection of the public health in light of new information. There should l^
So set time for this review, no penalty for the failure of EPA to conduct such a re-
view no need for a formal proceeding where none is justified, and no sunset on tof-
erances where a review is not justified and thus not underi,aken. Arbitrary time-
tables and schedules must be avoided. It is sufficient to authorize periodic review
within EPA priorities and resources. Experience shows that arbitrary schedules set
bv legislation are invariably unrealistic and cannot be met. Legislative schedules
impose political priorities upon a Federal agency that do not necessarily represent
sound soentific priorities. \^ise public policy requires that EPA be free to take all
scientific information into account in establishing its priorities for periodic review.

5 Phasing In the New Legislation. It will take time for EPA to assimilate the
new legislation into its existing systems, to propose and promulgate regulations, and
then to begin to implement the changes that are made to existing law, po icy, and
procedure.TTiis cannot be done immediately or according to a ngid timetable set by
Congress It must be done according to scientifically based priorities established by
EPA itself. Rigid timetables imposed by legislation wiU not represent true scientific
priorities and will ultimately be unworkable.

6 The Food Pipeline. The presence of pesticides in the food chain occurs not at
a single point in time, but over many years. A pesticide can be apphed to a food
today the food may be processed a year or more aRer that, the processed food be-
comes available to consumers still later, and it can remain in the marketplace and
kitchens throughout the country for many years. It is possible to stop using a pes-
ticide or to reduce pesticide use, on the farm at any particular point in time, but
nothing can be done to remove or alter the pesticide residues that exist from prior
legitimate use on food that has already entered the food pipeline. Appropriate legis-
lation must therefore reflect that food containing pesticide residues that were lawful
at the time of use must remain lawful throughout the subsequent lif^e of that food
unless new information demonstrates a serious health hazard. Any failure to do this
would represent an extraordinary disruption in the food supply.

7 Scientific Peer Review. Under present law, the cancellation of a pesticide toler-
ance can be challenged in a formal trial-type administrative heanng that is both
costly and time-consuming. GMA supports the use by EPA of scientific Peej review
to resolve issues relating to pesticide tolerances before EPA m^es a final cancella-
tion decision, in place of a trial-type hearing aRer that decision has been made. Con-
sistent with the view that all aspects of pesticide regulation must be based on sound
science GMA strongly believes that the use of scientific peer review to resolve toler-
ance issues will greatly enhance the ultimate decision. New administrative ap-
proaches such as phase-out/phase-down and label call-in are not justified. Suspen-
sion and cancellation are sufficiently fiexible procedures to permit EPA to apply new
information to existing pesticides.

8 Enforcement. Both EPA and FDA currently have extraordinarily strong en-
forcement authority that is more than adequate to implement any new pesticide leg-
islatfon New enforcement authority for EPA and FDA will preclude industiy sup-
port of legislatfon. Citizen suits and whistleblower provisions are extraneous to pes-
ticide le^slation and cannot be justified. Any legislation with enforcement provi-
sions of these types will be vigorously opposed.

9. International Harmonization. International scientific bodies also review the
safety of pesticides and establish tolerances for pesticide residues in food. Ihe Unit-
ed States officially participates, for examnle, in the Codex Alimentanus Commis-
sion which undertakes this task on a worldwide basis. New safety legislation should
therefore require that Codex determinations on pesticide safety be taken into con-
sideration by EPA, and that EPA explain any difference between the tolerances that
it sets and the determinations that are made by Codex.

10. User Fees. Federal regulation of pesticides should be accomplished by EPA
and FDA out of general appropriations, not from special taxes imposed on the regu-
lated industry. Pesticide regulation is intended to benefit the entire American pub-
lic, not just some small segment of the pesticide and food industries. User fees
would represent nothing more than a poorly disguised tax on food.

Conclusion

It is important to pare down pesticide legislation to the bare essentials, if it is
to be supported by the food industry. These ten principles establish the GMA posi-
tion on these matters. The legislation introduced by Representative Lehman (H.R.
1627) and Senator Pryor (S. 1478) meet these general principles, and we support
that legislation. The legislation recently introduced by the administration violates
virtually all of these principles and we strongly oppose it.

Juanita Duggan

Mr. Chairman and Members of the subcommittee, I am Juanita Duggan, senior
vice president for Government Affairs of the National Food Processors Association
(NFPA). NFPA appreciates the opportunity to appear today and to address the im-

{)ortant topics of pesticide regulation and food safety. We commend the Chairman's
eadership in holding a hearing on pesticide reform legislation and in providing a
forum for discussion of the critical pesticide policy choices facing EPA.

NFPA is the Nation's largest food trade association, representing the $400 billion
food processing industry. Our 500 member companies include food processors and
food packaging and equipment manufacturers. NFPA maintains and operates three
research laooratories, employing more than 80 Ph.D.'s and other scientific personnel
involved in a wide range of food processing research, including pesticide residue
analysis and investigation.

NFPA represents the vast majority of fruit and vegetable processors in the United
States, including processors of many minor crops. Consequently, NFPA has a vital
interest in pesticide regulatory procedures and food safety standards. NFPA strong-
ly supports programs to develop economical and effective alternatives to pesticides.
The food processing industry is making concerted efforts to develop alternatives pest
control techniques, including biological, cultural and mechanical controls, to support
integrated pest management (IPM) programs and to minimize pesticide use. NFPA
siipports further research and funding of these efforts, as well as steps to facilitate
EPA registration of effective biological control agents to further reduce pesticide use.
It is important to recognize, however, that, even with ongoing efforts to reduce pes-
ticide use, the responsible use of pesticides will continue to be necessary for the pro-
duction in the United States of an adequate, wholesome and nutritious food supply.

Consistent with the recommendations of the 1987 National Academy of Sciences
(NAS) "Delaney paradox" Report, NFPA supports statutory changes to establish a
uniform negligible risk standard for pesticide tolerances for raw and processed food,
and to give EPA sufficient authority to take into account the best available scientific
information in tolerance decisions. The Ninth Circuit Court of Appeals Decision in
Les v. Reilly confirms the need for legislation giving EPA additional flexibility in
tolerance decisionmaking in light of modem advances in safety testing and risk as-
sessment methodology.

NFPA supports reasonable efforts to reform the pesticide regulatory process, as
well as to resolve the Delaney paradox. We support legislation that streamlines the
procedure for removing hazardous pesticides from the market, promotes sound sci-
entific judgment in pesticide tolerance decisions, assures that tolerance decisions are
based on accurate exposure data, requires renewal of pesticide tolerances to assure
compliance with current safety standards, facilitates minor use registrations and
provides for national uniformity of pesticide tolerances.

Consistent with these objectives, NFPA strongly supports S. 1478, introduced by
Senators David Pryor and Richard Lugar, and its counterpart the Lehman-Bliley-
Rowland bill (H.R. 1627), which has broad bipartisan support in the House. We be-
lieve these bills provide the best vehicle for pesticide reform. These bills would make
important improvements in both the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFD&C Act). They
would streamline the pesticide cancellation and suspension processes, establish a
consistent negligible risk standard for pesticide tolerances for raw and processed
food, assure appropriate consideration of pesticide benefits and provide for national
uniformity for tolerances meeting current safety standards. Moreover, S. 1478 con-
tains specific provisions, which we strongly support, that would require EPA to im-

plement recommendations described within the recent NAS Report on Pesticides in
the Diets of Infants and Children.

The strength of S. 1478 and H.R. 1627 are reflected by the fact that they are en-
dorsed by a broad coalition of food industry organizations, including growers, proc-
essors and retailers, and have attracted solid Congressional support, with 20 Senate
co-sponsors and 222 House co-sponsors. The bills provide a solid foundation from
which to enact reasonable food safety legislation.

The administration recently released its own legislative proposals for pesticide re-
form. The focus of my testimony this morning will be to explain why NFPA supports
S. 1478 and H.R. 1627, rather than the administration's proposals. The administra-
tion's bill would restrict, rather than enhance, EPA's ability to employ the best sci-
entific evidence in tolerance decisions. Moreover, the administration's bill would go
far beyond reform of pesticide tolerance standards, as recommended by the NAS,
and would eliminate consideration of pesticide benefits, revise most major FIFRA
procedures to reduce public participation rights and scientific review requirements,
grant multiple additional enforcement powers to EPA and FDA and authorize citi-
zen suits in a variety of contexts. There is no demonstrated need for such a total
overhaul of FIFRA. Moreover, the administration's bill does not address an issue of
critical importance to the food industry; national uniformity of pesticide tolerances.
The broad, sweeping amendments in the administration's bill are contrary to the in-
terests of the food industry and consumers, and would serve to accelerate the loss
of safe and effective minor use pesticides, which are of particular importance to our
members.

We have made it clear that we support a uniform negligible risk standard for pes-
ticide 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 Delaney
clause with an equally rigid and arbitrary safety standard, to superimpose a dif-
ferent tolerance reevaluation schedule on top of the FIFRA reregistration process,
to abandon consideration of benefits in tolerance decision or to impose further data
requirements and cost pressures on minor uses.

The adjninistration nas argued that immediate legislative action is needed to
avoid the potential "crisis" created by the Ninth Circuit Court Decision in Les v.
Reilly. The Agency would have the Congress believe that unless immediate legisla-
tive changes are made the Agency will nave no choice but to revoke tolerances for
a large number of valuable pesticides with serious adverse consequences for agri-
culture and the food industry. In fact, however, the Agency's hands are not tied by
Les V. Reilly. EPA has sufficient authority under existing law to regulate pesticide
tolerances in a manner that would minimize the impact of the Delaney clause, and
there is no need to consider food safety legislation in a crisis atmosphere.

The potential devastating loss of agricmtural pesticides threatened by EPA is not
a necessary result of the Les v. Reilly decision but of EPA's concentration and co-
ordination policies. These policies are an EPA invention that has never been prop-
erly adopted as a regulation and should be abandoned. EPA's concentration policy
requires issuance of a section 409 food additive tolerance whenever there is a possi-
bility that a pesticide residue might concentrate in a processed food and its coordi-
nation policy mandates that, if a section 409 tolerance cannot be issued (because
of the Delaney clause or otherwise), EPA must also revoke the section 408 raw prod-
uct tolerance and cancel the underlying pesticide registration for the pesticide.

In September 1992, NFPA, the United Fresh Fruit and Vegetable Association and
other groups filed a petition urging EPA to rescind its concentration and coordina-
tion policies and no longer to require separate 409 tolerances for pesticides in proc-
essed food. The NFPA petition urges EPA to follow the language and intent of the
"flow-through" provision of the FD&.C Act, which provides that a pesticide residue
in processed food when ready to eat is lawful as long as the residue is not greater
than the tolerance for the raw commodity from which the processed food is made.
The NFPA petition demonstrates that the EPA policy was never envisioned by Con-
gress, and is based upon erroneous factual assumptions. Extensive data submitted
in support of the petition show that actual residue levels in agricultural commod-
ities and in processed food are well below raw product tolerances. The petition dem-
onstrates that continuation of current EPA policy will require numerous costly toler-
ance revocation proceedings, will force the Agency to prohibit the use of beneficial
pesticides that pose trivial risks and will thereby reduce the availability and in-
crease the cost to consumers of nutritious fruit, vegetable and grain products, at the
very time that FDA and the medical community are recommending greater con-
sumption of these foods to prevent disease. There, thus, is no sound legal or public
policy basis for EPA to continue its concentration and coordination policies, and
EPA should not be permitted to perpetrate these policies to create an artificial pes-
ticide crisis.

Although we believe that focused and reasonable legislation is the best way to re-
form the pesticide tolerance system, the administration's bill is clearly the wrong
vehicle for this purpose. The Administration bill does little to improve the pesticide
tolerance system, while incorporating numerous unnecessary and unjustified
changes to FIFRA. Our specific objections to the Administration bill and reasons for
favoring the Pryor-Lugar bill include the following:

OVERLY CONSERVATIVE AND RIGID FOOD SAFETY STANDARD

The Administration bill would impose an overly conservative and rigid safety
standard for pesticide tolerances. The bill would require a separate safety standard
for potential carcinogens, broadly defined to include any pesticide found to induce
cancer in man or animals, or found to pose "a potential dietary risk of cancer in
humans." The bill would specify the safety factors, uncertainty factors, and exposure
assumptions that must be used in risk assessment, including the use of a tenfold
safety factor and special risk factors for infants and children. This inflexibility in
risk assessment methodology would generate exaggerated risk estimates and under-
mine the soundness of regulatory decisionmaking. It would inhibit the EPA's ability
to exercise expert judgment, to take account of evolving scientific standards and to
consider all relevant safety and exposure information. S. 1478, on the other hand,
assures a science-based standard for pesticide tolerances and therefore represents
the better approach to resolving the Delaney clause problem.

EXAGGERATED EXPOSURE ASSUMPTIONS

The Administration bill would require EPA to use worst-case exposure assump-
tions in tolerance determinations. EPA would be required to assume that food con-
tains pesticide residues at full tolerance levels and that 100 percent of each crop
is treated. Extensive data collected by FDA, USDA and the food industry over the
past decade show that these assumptions are inaccurate, that pesticide residues in
raw foods are far below tolerance levels and that residues in processed foods are
often undetectable.

Under the Administration bill, actual crop treatment data could only be used in
exposure assessments where a registrant could prove that no subpopulation group
had higher exposure, and this determination would be subject to reevaluation at
least every 5 years. This would effectively preclude use of realistic pesticide expo-
sure data. The bill's artificial exposure assumptions would generate nighly inflated
risk estimates and would lead to unnecessary loss of many valuable pesticides, par-
ticularly for minor uses. By contrast, under S. 1478, EPA would be required, to the
extent possible, to calculate dietary exposure on the basis of the percent of food ac-
tually treated with a pesticide, and on the basis of the actual residue levels detected
in the food.

ESTABUSHMENT OF UNNECESSARY MULTIPLE TOLERANCES
FOR A PESTICIDE ON A SINGLE FOOD

Under the administration's bill, EPA would be authorized to set multiple toler-
ances for a pesticide on a single food at difTerent points in the distribution chain
{i.e., at harvest, at retail and after processing). In addition, the bill would authorize
EPA to establish numerous separate tolerances for different processed forms of the
same food. This would impose unnecessary additional registration burdens on pes-
ticide companies and would create substantial enforcement difficulties for FDA.
There is no need for a multiple tolerance system, and the public is likely to be con-
fused by establishment of separate tolerances for a single pesticide on different
forms of the same food.

Moreover, the Administration bill would require tolerances or exemptions for each
pesticide chemical residue in food, including each substance that is present in food
as a result of the metabolism or other degradation of a pesticide chemical. By con-
trast, S. 1478 would codify EPA's existing policy of considering pesticide metabolites
and degradation products to be subject to tne established tolerance for the precursor
chemical, unless EPA has determined that the metabolite or degradation product is
likely to pose different or greater health risks. The approach taken under S. 1478
would avoid the increased registration costs, administrative burdens and enforce-
ment complexities of establishing multiple separate tolerances for metabolites and
degradation products where there is no valid public health reason for doing so.

ELIMINATION OF BENEFITS CONSIDERATIONS IN TOLERANCE DECISIONS

The Administration bill would greatly limit the types of benefits that could be con-
sidered in pesticide tolerance decisions, would prohibit the continuation of a toler-

ance based on exceptional benefits beyond 5 years and would prohibit any consider-
ation of benefits in tolerance decisions after 10 years. The bill would prohibit EPA
from taking into account the value of a pesticide in maintaining an adequate, whole-
some and economical food supply even though scientists and public health authori-
ties now agree that adequate consumption oifruits and vegetaoles is a critical factor
in disease prevention. Prohibition of consideration of benefits for pesticide tolerances
would deprive growers of pesticides for which there are no alternatives, would un-
dermine the health and welfare of consumers and would not achieve a meaningful
risk reduction.

The Administration bill would permit consideration of benefits during a limited
transitional period only where it could be proven that loss of a pesticide would cause
"a significant disruption in domestic food production." This narrow standard would
ignore substantial regional or seasonal disruptions and would efliectively preclude
benefits considerations.

The administration's proposal to eliminate benefits considerations in pesticide tol-
erance decisions is inconsistent with the basic registration standard under FIFRA
and contravenes the fundamental policy set forth in section 1 of the administration's
own Executive Order 12366, which directs Federal agencies to consider the costs
and benefits of available regulatory alternatives and to adopt approaches that
"maximize net benefits" to society.

DECOUPLING OF TOLERANCE REVIEWS FROM FIFRA REREGISTRATION

The Administration bill would require EPA, within 180 days of enactment, to re-
view all existing pesticide tolerances and to identify each tolerance which does not
appear to meet the requirements of the law. EPA would be required to call-in data
and make a final determination with respect to most such tolerances within a 3-
year period. This accelerated review provision is impractical, would conflict with the
FIFRA re registration process and would give EPA discretion to eliminate valuable
food use pesticides without adequate procedural protections or a determination of
unreasonable risk. Accelerated tolerances renewal would impose heavy burdens on
EPA and pesticide registrants, and would create additional pressures for registrants
to decline to support valuable food use pesticides. By contrast, S. 1478 would syn-
chronize the schedule for reregistration and tolerance review decisions to ensure
that EPA's tolerance decisionmaking benefits from the data being developed under
the reregistration process.

NO TOLERANCE UNIFORMITY PROVISION

Under S. 1478, States and political subdivisions would be precluded from issuing
different tolerance limits, warning requirements or other restrictions on pesticide
residues in food, for pesticides registered or reregistered by EPA after April 25,
1985. This would secure EPA leadership in pesticide tolerance decisionmaking and
would avoid the consumer confusion and substantial burdens on interstate com-
merce caused by special State requirements. Consumer protection would be assured
by limiting required uniformity to pesticide tolerances supported by full scientific
testing and recent EPA approval. States would be permitted to petition EPA for ap-
proval of a diflerent tolerance on the basis of compelling local conditions. The Ad-
ministration bill contains no national uniformity provision, thus inviting States to
issue different and conflicting tolerance limits, which would undermine the Federal
regulatory system.

NO INTERNATIONAL HARMONIZATION PROVISION

S. 1478 would require EPA, in establishing a pesticide tolerance, to take into ac-
count CODEX recommended international residue limits and to explain any depar-
ture from the CODEX limits. Setting United States tolerances consistent with estab-
lished CODEX limits, where adequate safety data is available, would foster harmo-
nization of international pesticide standards and would promote increased inter-
national trade in agricultural products. In spite of the administration's professed
commitment to international harmonization, the Administration bill does not con-
tain a comparable provision.

UNNECESSARY EXPANSION OF FDA ENFORCEMENT AUTHORITY

The Administration bill would grant FDA broad new enforcement power, includ-
ing recall, embargo and civil penalty authority, with respect to pesticide tolerance
violations for food products. FDA would be empowered to embargo food products for
up to 30 days anci to require immediate recall of food products on the basis of a
"reason to believe" that the product is adulterated without any right to a

preenforcement hearing or review, and regardless of the magnitude of the alleged
violation. Civil penalties of up to $250,000 per violation could be imposed against
companies for any pesticide tolerance infraction, regardless of whether a potential
health risk were involved. FDA already possesses ample enforcement power, includ-
ing seizure, injunction and broad criminal penalty authority. There is no dem-
onstrated need to grant FDA additional enforcement authority for pesticide toler-
ance violations.

ILL-CONSIDERED PHASE-OUT AUTHORITY

The Administration bill would grant EPA new authority to "restrict, reduce or
eliminate" the use of a pesticide where "credible scientific evidence" indicates that
use of the pesticide is reasonably likely to pose a significant risk to humans or the
environment. This would empower EPA to limit or prohibit the use of a pesticide
without the external scientific review and procedural protections guaranteed under
the cancellation process, without any consideration of the pesticide's benefits, and
on the basis of evidence that is too weak, incomplete or inconsistent to support a
cancellation. Phase-out orders would generate damaging adverse publicity, cUsrupt
sales of food products and cause irreparable harm to food producers and consumers.

Phase-out authority is unnecessary. Existing proposals to streamline the cancella-
tion process would provide ample authority for prompt cancellation of pesticides that
pose demonstrated risks and would assist in promoting consumer confidence in the
food supply.

CITIZEN SUITS

The Administration bill would authorize any person to bring a lawsuit in Federal
court against EPA, a pesticide registrant or any pesticide user, except for a farmer,
for any alleged violation of FIFRA or of any EPA pesticide regulatory requirement.
This provision would increase the litigation burdens of Federal courts, would inter-
fere with EPA's enforcement prerogatives and would subject pesticide producers and
users other than farmers to expensive and burdensome lawsuits.

WHICTLE BLOWER PROVISION

The Administration bill would give broad legal rights to any employee who alleges
that he has been terminated, or that his employment status has been adversely af-
fected, in retaliation for his bringing a legal action, or threatened legal action, for
an alleged FIFRA violation. This provision would impair employer-employee rela-
tionships and impose further unnecessary burdens on employers and agricultural
producers.

REVISED SUSPENSION PROCEDURE

The Administration bill would eliminate the current right of pesticide registrants
for an expedited hearing on a proposed suspension order. EPA would be authorized
to suspend a pesticide registration without a hearing for 180 days. If a cancellation
proceeding was initiated within the 180 day period, the suspension would remain
in effect until the completion of the cancellation process. This provision would give
EPA excessive discretionary authority, would deny registrants a fair hearing and
would cause irreparable harm to food producers who market products containing a
suspended pesticide. Post-suspension court review, as provided for in the bill, would
not offer a meaningful substitute for a presuspension hearing.

Proposed improvements to the cancellation procedure will give EPA sufficient
power and flexibility to remove hazardous pesticides from the market in a timely
manner. In true emergencies, EPA would retain its current authority to suspend a
registration pending the conclusion of the expedited hearing.

By contrast, S. 1478 would retain existing suspension procedures, but would au-
thorize EPA to issue an emergency suspension order before issuing a proposed can-
cellation notice. This would permit EPA to take prompt action against truly hazard-
ous pesticides without the delay inherent in developing the full risk-benefit evalua-
tion required for a cancellation notice. This provision, coupled with the 1988 FIFRA
amendment which eliminated EPA's obligation to indemnify owners of existing
stocks of suspended pesticides, would provide EPA sufficient authority to suspend
registrations for pesticides that pose a true imminent hazard. EPA has shown no
justification for granting the additional extraordinary suspension authority in the
Administration bill.

BURDENSOME FEES

The Administration bill would require EPA to collect fees to cover the costs of ad-
ministering the pesticide tolerance provisions of the Act, and would amend FIFRA
to mandate additional reregistration and maintenance fees for food use pesticides.
User fees of this kind unfairly penalize the regulated industry, undermine con-
fidence in EPA's enforcement integrity and create additional disincentives for reg-
istrants to support valuable food use pesticides, particularly for minor crops.

We commend the subcommittee for opening a dialogue on pesticide reform and we
stand ready to work with the Congress to develop food safety legislation that will
give EPA the tools necessary to reach reasonable and scientifically defensible toler-
ance decisions. The Administration bill is not, in our view, the right vehicle for
achieving this goal. We strongly believe that S. 1478 ofiers a reasonable, balanced
and focused pesticide reform package, and we urge this committee to adopt S. 1478
as the model for crafting any legislation.

Jim Bender

Mr. Chairman, and Members of the subcommittee, I appreciate the opportunity
to participate in this hearing. I am Jim Bender, an organic farmer from Weeping
Water, Nebraska.

A central issue for pesticide policy concerns what American agriculture would be
like with only minimal reliance upon chemical pesticides.

There are several ways to pursue this subject. An obvious one would be to study
contemporary farms in which pesticides have been minimized or eliminated. Espe-
cially useful would be farms that are otherwise typical. Bv typical I mean farms
that have developed with their fair share of agronomic challenges, do not rely upon
inputs unavailable to agriculture in general, and have not received grants or otner
special funding.

Our farm comes to mind. It has been free of pesticides on all the land since 1980,
and certified organic since 1990. It is a four generation family farm, 642 acres, lo-
cated between Lincoln and Omaha at the very western edge of the nonirrigated
corn-belt, which results in moisture extremes. Virtually all of the farm has been des-
ignated as potentially highly erodible by the Soil Conservation Service. The topsoil
on many of the hillsides of the farm is thin as a result of profound soil erosion dur-
ing the first decades of this century.

How does this farm perform? In many ways it is highly productive and conserving
of resources. It competes with our chemical based neighbors in yields. ^^ It is excep-
tionally resilient in years with difiicult weather or economic conditions. We receive
visitors and agricultural researchers each year who are complimentary about weed
control. An aggressive, multifaceted soil conservation program coincides well with
the pesticide-free cropping. It provides employment opportunities for local youth. Fi-
nally, while the farm nas enjoyed special organic markets the last 2 years, prior to
that mere conventional agricultural markets paid for land, large modern machinery,
buildings, and other infrastructure.

The success of farms such as ours gives rise to a question. If these farms effec-
tively address so many problems and offer other advantages, why then do our neigh-
bors continue to farm in ways heavily reliant upon chemical pesticides? That is a
question with no easy answer. A starting point, nowever, is the ways that Federal
agricultural policy influences agricultural practice. There are many examples. Policy
penalizes crop rotations that are essential no low and no-pesticide farming ^2; it gen-
erally does not orient research to support this kind of farming i^. Federal Policy on
highly erodible farm land places high priority upon pesticide based cropping prac-
tices ^'*. Policy contributes to overly optimistic views oi pesticide risk ^^. Current poli-

^'^For additional data about yields and other performance indicators, see Bender, Jim. 1994.
Future Harvest, University of Nebraska Press. Lincoln and London, p. 123-13L

^See National Research Council. 1993. Soil and Water Quality, National Academy Press,
Washington DC. chapter 4. especially p. 153-6.

13 See National Research Council. 1989. Alternative Agriculture. Washington, DC. National
Academy Press, p. 6.

"See, for example, Schertz, D.L., Bushnell, J.L. 1993. "USDA Crop Residue Management Ac-
tion Plan," Journal of Soil And Water Conservation. Volume 48. Number 3. May-June. pp. 175.

1^ An example of regulatoiy laxity which results in unfounded optimism is the Environmental
Protection Agency's treatment of the issue of inert ingredients of pesticides. See, for example.
General Accounting Office. 1986. Pesticides: EPA's Formidable Task To Assess and Regulate:
Their Risks. GAO/RCED-86-125. Washington, DC, U.S. Government Printing Office. Chapter
5.

cies permit agricultural benefits to override health and safety concerns. These
things and others influence agricultural practice. ^^ They also begin to explain why
farms such as ours are isolated, with so little influence.

In conclusion, there are currently low and no pesticide agricultural systems creat-
ing solutions to basic agricultural problems. Their efliectiveness will continue to be
limited until Congress removes existing obstacles.

Keith W. Eckel

The American Farm Bureau Federation appreciates the opportunity to address
the issues raised by the administration's pesticide reform package and related pro-
posals. Farm Bureau is the Nation's largest general farm organization, representing
producers of all commodities in 50 States and Puerto Rico.

The concern over pesticide policy is intensifying due to several significant forces
influencing the regulatory process. These forces include:

• Reregistration mandates created by the 1988 amendments to the Federal Insec-
ticide, Fungicide and Rodenticide Act (FIFRA) have forced safe and effective
pesticides off the market, not for safety reasons, but for economic reasons. Pes-
ticide losses are impacting growers throughout the country.

• The Les vs. Reilly Ninth Circuit Court of Appeals Decision forcing the Environ-
mental Protection Agency (EPA) to enforce the zero tolerance Delaney clause
could dramatically impact the availability of fruits and vegetables, especially if
EPA implements its coordination policy.

Farm Bureau supports efforts to enact reasonable reforms to the Federal Insecti-
cide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cos-
metic Act, (FFDCA). We believe the task of amending FIFRA and FFDCA should
be done with clear purpose and intent of designing solutions to identified problems.
The process simply is not able to sustain a "wish list" approach to reauthorization.

Several difierent pesticide proposals are currently pending before Congress. Farm
Bureau supports the Pryor/Lugar bill, S. 1478, and H.R. 1627, by Representatives
Lehman, Bliley and Rowland. This legislation has broad bipartisan support in both
the Senate and the House, where it is now cosponsored by more than a majority
of House Members.

The Federal Government has primary responsibility for safeguarding the food
supply, but farmers are responsible for growing food safely. Growing and raising
safe food is our top goal, and we are confident that new research breakthroughs and
innovations will continue to yield a host of products and agricultural technologies
that will help farmers provide an even safer, more healthful and affordable food
supply. However, it is critical to remember that until research advances reach the
farm gate, policies that arbitrarily reduce pesticide use will affect the supply and
aflbrdability of our food supply. These changes will afiect low income Americans
first, those who already consume 20 percent less fresh fruits and vegetables than
people in higher income brackets. ^"^

While a number of reforms to current law are needed, our pesticide policies are
fundamentally protective of public health. Any reforms ought to be by design, in-
tended to make a safe system safer and more efficient, not simply more bureau-
cratic. We share the views of former U.S. Surgeon General, Dr. C. Everett Koop
when he said:

"/ do not know of a single instance where exposure to pesticides on foods in
the marketplace is a source of any danger to children or adults. It's a risk
of zero."

Dr. Bruce Ames of the University of California at Berkeley adds a word of caution
to those who believe that tighter regulation will improve food safety:

"The attempt to prevent cancer by regulating low levels of synthetic chemicals by
using worst-case, one-in-one-million-risk scenarios is not scientifically justified.
It diverts resources from much more important risks. Perversely, it decreases con-
sumption of foods that help to prevent cancer."

i^For further elaboration upon the relationship between policy and agricultural practice, see
"The Power of Policy," in National Research Council. 1989. p. 65-^4. The Pesticide Food Safety
Act of 1994 (H.R. 4091), introduced by Representative Henry Waxman, avoids this and other
problems.

^^ Steven M. Lutz, David M. Small wood, James R. Blaylock, Mary Y. Hama, Changes in Food
Consumption and Expenditures in Low-Income American Households During the 1980's, USDA/
ERS Human Nutrition Information Service, 1993.

THE GOAL OF LEGISLATION

The goal of legislation should be to design improvements to the current regulatory
system. Several important areas should be addressed.

First, the primary objective of this effort should be to resolve the differences be-
tween FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA) as they relate
to pesticide registration and the tolerance setting process. The "Delaney Paradox,"
as described by the National Academy of Sciences (NAS) in its 1987 report, stems
from the contradictory regulation in the zero risk Delaney clause vs. the risk -benefit
standard in FIFRA and section 408 of the FFDCA. The "paradox" in the law is that
strict compliance to the Delaney clause prevents newer, safer but minutely carcino-
genic pesticides from reaching farms to replace older, riskier pesticides. Continued
adherence to a "zero risk" public policy is neither scientifically credible nor achiev-
able. Coordinating efforts in FIFRA and FFDCA through a negligible risk standard
is an essential component for pesticide reform.

Second, legislative reform should create a single regulatory standard applicable
for both fresh and processed foods.

Third, there is general consensus that the process for removing pesticides deter-
mined to present an unreasonable risk to health or the environment takes too long
and should be expedited.

Fourth, it is essential that newer, safer products and technologies be developed
and approved more quickly to replace those being lost. The lack of replacement
products is the most frequently voiced concern by farmers when discussing pesticide
policy.

Fifth, the loss of pesticides for "minor uses" is acute and needs to be resolved.
Separate legislation, sponsored by Senators Inouye and Lugar, would alleviate this
concern. The problem is time-sensitive and needs to be addressed in this Congress.

Sixth, is the need to retain the risk-benefit consideration in the registration and
tolerance setting process. The most compelling description of the benefits from pes-
ticide use was given by Nobel laureate Norman Borlaug:

". . . [I]f U.S. farmers used the agricultural technology of the 1930's and
1940's to produce the harvest of 1985, they would have to convert 75 per-
cent of the permanent pasture lands in the United States or 60 percent of
the American forests and woodland areas to cropland. Even this may be an
underestimation, since the pasture and forestlands are potentially less pro-
ductive than the land now planted to crops. This would greatly accelerate
soil erosion and destroy wildlife habitats and recreational areas."

The benefits of pesticides accrue to all of society, not just to farmers, and their
consideration in pesticide regulatory decisions is critical for a reasoned and coordi-
nated policy. The benefits of pesticide use must be balanced with risks along with
the need to feed a world population that is growing by nearly 100 million people
every year.

REDUCING PESTICIDE USE

According to National Agricultural Statistics Service surveys, total pesticide use
has trended downward since 1982. (Appendix 1) i® This is an important factor that
should be considered when setting policy. Farmers have adopted new technologies
that have resulted in tremendous efficiencies over the last decade. Further effi-
ciencies will come through new technologies and public policies that encourage,
rather than impede their development and use. We are troubled by what appears
to be a prevailing attitude so heavily weighted toward the removal of products, rath-
er than the introduction of newer, safer replacements. We continue to support inno-
vation in farm practices that will reduce pesticide use. Some of the ideas and op-
tions that Farm Bureau has advocated during the past several years that will re-
duce total pesticide use include research to find alternative pest control products
such as biological control agents, microbial pesticides, resistance management in-
cluding the use of genetic engineering, growth regulators and breeding for host
plant resistance. We also believe that improvements in pesticide application tech-
nology and improved applicator training in reduced use methods will also substan-
tially decrease the need for pesticides without burdensome new regulations aimed
at limiting a farmer's control options.

Dollars are needed to fund this type of eflbrt, and the administration's package
does not specify the dollar commitment its intend to seek as part of its use reduction

18USDA/ERS Report #622 and USDA/NASS reports "Agricultural Chemical Usage, Field
Crops Summary" for 1990, 1991, 1992 and 1993.

strategy. The need for research dollars for alternatives to pesticides must be the be-
ginning portion of any strategy that has as its goal substantial reductions in pes-
ticide use.

The lack of new moneys for research on pesticide reduction projects is critical.
Right now, the American Farm Bureau Research Foundation is reviewing eight new
research projects totaling $370,000 that will develop information that larmers can
use to reduce pesticide use. One project is to examine biological control for cotton
insect pests in Texas. We can finance only a fraction of the research projects that
come tnrough our foundation. The National Coalition for IPM estimates that the
total dollar commitment to achieve meaningful results so that farmers can further
reduce pesticide use is $50 million per year for the next 5 years.

Already much is being done. In April, at the National Symposium for Integrated
Pest Management, over 200 research projects highlighted the vast array of new
ideas that will help farmers reduce total pesticide use. We have long been an advo-
cate of U'M and ot reducing the many constraints to broader utilization of this pest
management philosophy. For the record, I would like to submit and call your atten-
tion to two items. First is a report prepared by Dr. Michael Fernandez of the Senate
Agriculture Committee staff summarizing some of the many successes attributable
to IPM. Second, a report from last year by the National Foundation for Integrated
Pest Management exploring the many constraints which hamper greater utilization
of IPM. This information was gathered through a series of regional producer work-
shops. We need to build upon the vast and impressive research network throughout
the land-grant university system to develop sound production and management
practices uiat will enable farmers to minimize pesticide use.

Farm Bureau policy for minimizing pesticide use is clear and supportive of the
following:

1. The widespread promotion and use of integrated pest management (IPM) as a
method of reducing costs, risks, liability and total dependence on farm chemicals.
Expanded educational and pesticide training certification programs should encour-
age the adoption of IPM.

2. Continued research and development of pesticides which degrade more rapidly,
are less environmentally persistent and are compatible with accepted Il'M practices.

3. Increased biological pest control research to determine where biological pest
control measures can provide practical and feasible substitutes for nonbiological pes-
ticides.

4. A beneficial insects category in USDA's competitive grants program.

5. Improved training programs on the proper handling and safe use of pesticides
to ensure the safety of handlers, applicators and agricultural workers.

6. A well funded IR-4 program. Funding for the IR-4 program has crept up, but
it is still far short of the $14 million needed to remove the oacklog of outstanding
requests.

7. Continued research on the effects of farm chemicals on the environment. Con-
gress can also create incentives for farmers to reduce pesticide use and to find safer
alternatives. Incentives could include:

• Streamlining the EPA registration priorities for EPA. Right now EPA
has registration priorities for pesticides that replace section 18's, for
"safer" pesticides, for pesticides that reduce use, for pesticides used on
minor crops and for biological pesticides. Because EPA has so many reg-
istration priorities, nothing becomes a real priority. We suggest EPA
focus in on the areas where farmers' control options are most limited
and where risk is highest without classifying registration priorities by
pesticide type.

• EPA should work to harmonize State/Federal/intcrnational research and
development incentives for pesticide registrants.

Farmers will continue to reduce pesticide use by achieving greater efficiencies
from the adoption of new technologies and information transfers. The administra-
tion has taken some positive steps toward meeting some of our goals, but more is
needed. A greater focus is needed on increasing the number of pioduct registrations
approved for use. The loss of key products without approved replacements is jeop-
ardizing much of the progress we have made. Farmei-s nave shown that when prov-
en new technologies become available, they will adopt them.

BUILDING UPON OUR CURRENT FOOD SAFETY S\'STEM

The central question to the pesticide debate is "How can our current food safety
system be improved, without undermining what is generally viewed as successful

in producing the safest and most abundant food supply in the world?" This is also
the question Congress must answer if it expects to resolve the gridlock. Our perspec-
tive is clear. While our current system needs improvement, the evidence is over-
whelmingly in favor of building upon what we have, rather than making drastic
changes.

There is a lot of good news for the American food consumer: the supply of food
is safe and bountiful, quality is unparalleled, variety is ever-expanding and prices
are reasonable. The American farmer/govemment/university food production system
is unrivaled. The quality of life and health provides sufficient evidence and argu-
ment to build upon our current system.

It is important to note that while modem technology has greatly improved our
ability to measure or detect the tiniest trace of chemicals in food, we have had no
increase in our ability to make these numbers useful or meaningful to the food pol-
icy process. This results in periodic food safety scares. They do not mean that our
current system needs an overhaul. Residue testing is a good example.

In May 1991, the U.S. Department of Agriculture implemented the Pesticide Data
Program (PDP) to collect objective, comprehensive data on pesticides in fresh fruits
and vegetables. In April, results from 1992 were released. ^® In 1992, the PDP ana-
lyzed 5,750 fruit and vegetable samples and found that 61.2 percent of the samples
contained detectable residues.

At first glance, this may seem high, but closer examination reveals otherwise.
Only 63 of 5,750 samples contained residues in violation of the tolerance. Keep in
mind that the tolerance is the safe and legal limit of the amount of pesticide residue
that may be present in raw or processed foods. Fifteen of those 63 samples with ille-
gal residues were from imported food. Fifty-three examples had residues where no
tolerance was established by the EPA. Only 10 samples contained residues in excess
of the established tolerance.

The PDP also compared detected residues with the pesticide tolerance for 40 pes-
ticide/commodity pairs. Of those pairs, only five pairs resulted in a mean concentra-
tion which exceeded 10 percent of the tolerance, with the highest value representing
just 22.5 percent of the established tolerance. In other words, a minimum tenfold
safety margin could be added to the tolerance for 35 of the pesticide/commodity
pairs and the mean detection would be under the established tolerance. For some
pesticide/commodity pairs, the safety margin could be increased by as much as 200
times and residues would still be under tolerance. Regrettably, some groups have
used our increasing ability to detect as a means to generate interest among the
media and fear among the public.

This data indicates that our current food safety system works and changes need
to build upon what is already a solid foundation.

In reviewing the many issues addressed in the pending legislation, we are trou-
bled by much of what is in the administration proposal. We believe that there is
a need for reasoned, careful reforms in both FIFRA and FFDCA. We do not believe
the administration's proposal accomplishes the challenge of improving our current
system. Rather, it proposes a number of new authorities and changes to FIFRA and
FFDCA that are simply unjustified. The challenge is to improve the regulatory sys-
tem, not merely to make it more difficult to navigate.

Our specific concerns with the administration proposal include the following.

Loss of Benefits Consideration in the Registration and Tolerance Setting Proc-
ess. The administration proposal will not allow the consideration of benefits of a
pesticide in excess of the risk standard, and will eventually phaseout benefits con-
sideration altogether. A risk-only approach to pesticide regulation does not reflect
the contribution of pesticides to our food supply. It is important to note the benefits
society derives from the safe and judicious use of crop protection chemicals. Among
them:

• Agricultural chemicals reduce the risks of crop failure and stabilize food pro-
duction. Farm Bureau has catalogued a list of crops affected by the loss of
minor use pesticides to demonstrate the role pesticides play in food production.
"The Loss of Safe Pesticides for Minor Crops" cites examples from 32 States,
and we have provided the subcommittee with copies of the report. We have also
submitted research from Texas A&M University entitled "The Economic Im-

1^ Pesticide Data Program (PDP), Summary of 1992 Data, U.S. Department of Agriculture, Ag-
ricultural Marketing Service, 1994.

pacts of Reduced Pesticide Use on Fruits and Vegetables" "^^ as further evidence
of the benefits derived from pesticide use.

• Agricultural chemicals allow food to be produced on less land. Land that would
otherwise be needed for food production can be devoted to wildlife habitat and
other beneficial uses. Pesticides also allow environmentally fragile lands to be
idled. Fewer farmed acres reduce the amount of water needed for irrigation.

• Agricultural chemicals allow the use of soil conserving practices that reduce the
soil erosion that results from increased cultivation to control weeds.

• Agricultural chemicals reduce farm costs. Reduced costs allow us to compete in
world markets. Lower farm costs also translate to lower food costs which en-
courage consumption of foods important to health. There is a growing body of
evidence that greater consumption of fruits and vegetables help prevent cancer.
Higher food costs are likely to limit the production of foods we should be con-
suming most. In 1988, the Surgeon General's Report on Nutrition and Health
said this:

"Some epidemiologic evidence suggests that frequent consumption of vegeta-
bles and fruits, particularly dark green and deep yellow vegetables and
cruciferous vegetables, may lower risk for cancers of the lung and bladder
as well as some cancers of the alimentary tract."

• Agricultural chemicals allow food to be grown domestically, rather than depend-
ing on imports where we have little to no control over food production metnods.

• Agricultural chemicals improve the quality and storability of food. Consumers
can expect more perishability at the marketplace as a result of pest infestation and
consumer rejection of products with poor appearance and quality if farmers are
forced to arbitrarily reduce pesticide use. Consumers can expect poorer quality of
foods that are typically stored for long periods, like apples. High quality foods are
essential for meeting export standards as well. Customer countries will restrict
United States products if they do not meet quality or phytosanitary standards.

• Agricultural chemicals have substantially decreased farm labor requirements,
as well as associated costs.

The Clinton plan would not permit approval of any pesticide tolerance with a
greater than one-in-one million lifetime cancer risk, regardless of benefits. Ignoring
the benefits of crop protection chemicals in the registration process presumes that
a widely available and affordable food supply plays no role in human health. In
choosing to eliminate benefits consideration, EPA has failed to make its case. Why
after three decades is this change of course warranted? Where is the evidence sup-
porting this? What measurable gain in food safety wUl be seen from this? Farm Bu-
reau supports the consideration of both the risks and the benefits of pesticides in
the evaluation of chemical products and cannot support the administration's pro-
posal.

Negligible Risk. The administration's proposal defines negligible risk as a one-in-
one million cancer risk over a lifetime using 100 fold safety factors. This rigid safety
standard is an inflexible standard that cannot be changed with improvements in
science and technology. In some cases, the new standard may be worse than the
Delaney clause due to its inflexibility.

It is impossible for Farm Bureau to predict the impact and loss of current reg-
istrations if EPA were forced to implement the new standard. We urge the sub-
committee to ask EPA to analyze the outcome to current tolerances and registra-
tions and ultimately, the impact on food production under the proposed negligible
risk standard.

Farm Bureau supports a flexible negligible risk standard. One of the primary les-
sons from Delaney is that rigid standards do not adapt to changing science. A flexi-
ble risk standard recognizes that risk assessment is constantly evolving and improv-
ing. A flexible standard that allows the EPA to update its methodology to keep pace
with the developing science of risk assessment is an essential part of a coherent food
safety policy.

Tolerance Uniformity. The administration's plan has no provision for tolerance
uniformity. States would not be prohibited from setting pesticide tolerances that are
more restrictive than Federal standards. Farm Bureau supports provisions that pro-
hibit States from establishing pesticide tolerances that are more stringent than Fed-
eral tolerances, unless very special local conditions warrant consideration for a more
restrictive tolerance.

20 Ronald D. Knuteon, Charles R. Hall, Edward G. Smith, Samuel D. Cotner, John W. Miller,
Economic Impacts of Reduced Pesticide Use on Fruits and Vegetables, 1993.

Exposure Analysis. Farm Bureau supports the use of actual pesticide use data in
exposure analysis, wherever possible. We strongly disagree with the administration
over its intention to use exaggerated exposure assumptions, such as 100 percent of
crop treated at full label rate and minimum preharvest intervals. We question the
purpose of the data collection provisions if worst-case assumptions are mandated
anyway. As written, this provision will result in the continuation of overstated and
unrealistic risk estimates.

Phase-Out /Phase-Down. Farm Bureau disagrees with the administration's plan
that would allow EPA, without a complete scientific review, to phase-out/phase-
down a pesticide by imposing production caps or eliminating uses. This new author-
ity is extremely vague and loose. This is seemingly a "catch-all" provision that pro-
vides the Agency with new authority for arbitrary action. From the perspective of
a farmer, this provision would add even more uncertainty and risk to our farm man-
agement decisions. We believe it would also hinder the mutual goal of greater adop-
tion of integrated pest management and other similar strategies. It is unclear what
situations this is intended to address and why existing or proposed expedited can-
cellation and suspension authority are inadequate.

Enforcement Provisions. The administration proposal spells out a broad new set
of enforcement guidelines, including requiring all private applicators to keep records
of all pesticides they use, both general and restricted use.

Farmers will be required to notify EPA where records are maintained and will
be required to furnish EPA a copy of the records on written request. Any employee
of the United States or States who has been designated by the EPA will have the
authority "to enter and inspect" to obtain: a) Samples of any pesticide; b) Copies of
any records or of any pesticide labels; c) Copies of documents related to compliance
under the Act; d) Copies of any data or samples of any specimens involved in the
testing of any pesticide; and e) Samples of any places where pesticide residues may
be found, including, without limitation, agricultural commodities, animals, pests,
soil, or water.

Equally troubling is the elimination of the first offense warning to farmers now
required in current law. The overwhelming volume of regulations under FEFRA
makes it essential that farmers be given a notice and warning of a violation in the
first instance.

We are also troubled by the substantial increase in civil and criminal penalties
to registrants, commercial applicators and dealers, especially the smaller family
businesses. Particularly threatening is that the standard for any FEFRA violation
has been changed from a "knowing violation" to a mere act of negligence. This will
surely afiect manv small, family owned dealerships and commercial applicators
throughout rural America, and also the ability of farmers to obtain the tools, infor-
mation and services they need.

The administration's enforcement provisions are excessive and unjustified. There
has been no demonstrated need for such drastic changes in policy.

Whistleblower Provision. The Administration bill proposes to establish broader
authority and rights to any employee who alleges wrongful termination of employ-
ment, or that the employee's status has been adversely affected in retaliation for
bringing, or threatening to bring, a legal action alleging a violation of FEFRA.

Again, there has been no documented need or justification for such sweeping new
authority in FEFRA. It will add substantial new risk for farmers and impair em-
ployee/employer relationships.

Citizen Suits. Farm Bureau opposes provisions in the administration's plan that
provides an opportunity for citizens to ask the EPA "to commence an action against
any agricultural producer who is alleged to have violated . . . any provision of the
Act." Enforcement by citizen action implies that the Government is incapable of en-
forcing the law by itself and needs help from citizens to uphold the law. Citizens
are not trained or qualified to properly enforce or even report on suspected viola-
tions of Federal pesticide law and is a provision that Farm Bureau strongly opposes.
If Congress sees fit to create Federal laws that the Government cannot enforce, then
certainly citizen action is not the answer. Allowing citizen action against farmers
is unnecessary, punitive and forces farmers to delend themselves against alleged
violations that will be prosecuted by the Federal Government.

Pesticide Cancellation. We support changes in FIFRA, outlined in 8. 1478, that
will streamline the process for cancellation of potentially dangerous pjesticides. The
existing cancellation process is lengthy and hampers EPA's ability to remove poten-
tially dangerous pesticides from the market in a timely manner. The cancellation
process should move quickly if a full and complete analysis of the data supports the
cancellation of specific pesticide products. However, in fairness to both the reg-
istrant who has invested millions of dollars in research and development, and

farmers who depend on the availability of these tools, the cancellation process
should continue to include adjudicatory hearings and the opportunity to present evi-
dence and to cross examine. Farmers rely on the registration process for safe, effec-
tive pest control products. If new evidence supports the cancellation of products,
that process should move quickly. Much of the integrity of pesticide registration re-
lies on the ability to deal quickly with products determined to pose unreasonable
risks.

Suspension. The administration's bill would eliminate the right of a registrant to
an expedited hearing on a proposed suspension order. EPA would be authorized to
suspend a pesticide registration for 180 days without a hearing and without requir-
ing a notice of intent to cancel. This provision would deny registrants a fair expe-
dited hearing and would create unnecessary confusion and uncertainty for farmers
who market products containing a suspended pesticide. For these reasons Farm Bu-
reau opposes the bill's suspension provisions.

Label Call-in. We support the concept of a label call-in program as long as this
authority extends only to minor label changes. Label call-in should not remove crop
uses or substantively alter the use of the product. While a label call-in program
might be one area where agreement could be forged, the current language of the
Administration bill is much too broad and gives EPA virtually unlimited authority
to make changes.

Integrated Pest Management. Last September, the administration set a goal of im-
plementing IPM programs on 75 percent of crop acreage by the year 2000, but the
new bill properly sets no such numerical goal. To accomplish the IPM goals, the ad-
ministration proposes to require pesticide training and certification programs to in-
clude instruction in integrated pest management techniques. Pesticides critical for
IPM programs, but which may pose higher risks, may be available for prescription
uses. Such changes are encouraging but must be accompanied by an on-going com-
mitment to overcome numerous impediments. Farm Bureau is fully committed to
working with the Agency on this.

We are concerned that the bill does not identify any specific actions or Federal
funds to develop research and new technologies that will allow farmers to achieve
wider adoption of IPM. We strongly encourage that additional Federal research
moneys be appropriated for IPM research and technology transfers.

Farm Bureau has been a strong proponent of efTorts to expand the utilization of
integrated pest management. We applaud the administration for their work in this
area.

Pesticide Use Data Collection. The administration plans to collect additional pes-
ticide use data to improve pesticide regulatory decisions. Farm Bureau supports the
collection of actual residue data from farm products to establish use patterns for
pesticides. This data should be used in the pesticide registration, reregistration, can-
cellation and special review process only. We cannot support the administration's
mandatory record keeping proposal for all pesticides, due in large part to its ouni-
tive nature that includes inspections of records by Federal employees and others.
We also find it inconsistent that the legislation emphasizes data collection, yet fails
to allow, for practical purpose, the use of that data in determining exposure assump-
tions.

Minor Use Pesticides. Farm Bureau is a member of the Minor Crop Farmer Alli-
ance and strongly supports the "Minor Crop Pesticides Act of 1993," (S. 985 and
H.R. 967) introduced by Senator Inouye and Representative de la Garza. The admin-
istration recognizes the minor use problem and has incorporated some provisions
similar to the reforms advocated by the Inouye/de la Garza proposal. While gen-
erally positive and consistent with those of S. 985/H.R. 967, we oelieve they need
to be strengthened in order to achieve the intended solutions so desperately needed.
Under their plan, exclusive data use will be extended for 2 years instead of 10. IR-
4 funding will be expanded. Transitional registrations will continue until reregistra-
tion is complete for specific pesticides. These reforms move toward our objective.
Farm Bureau encourages the committee to act on this very time-sensitive problem
this year. A copy of the Minor Crop Farm Alliance statement has been submitted
for the record.

Reduced Risk Pesticides. We support the efi'ort to establish guidelines for reduced
risk pesticides. We also support provisions that create incentives for registrants to
develop safer pesticides so farmers can use them once they are registered. We are
concerned about the potential for creating a stigma on products that may not meet
subsequent guidelines to qualify as "reduced risk" but nonetheless are safe and law-
fully registered for use. Furthermore, we would urge caution and consideration over
the potential for such a designation to be misused by retailers or food processors

in dictating which products should be used. The objective of a reduced use policy
should be to expedite the approval process for those products that meet such guide-
lines.We support the administration's plan to give registration applications that
meet the new criteria priority and expedited review and thus also qualify for exclu-
sive data use. We also support conditional registrations for biologically based pes-
ticides before a full data set is developed.

Conclusion

The concern over pesticide policy is a concern that farmers share. But our view
is tempered by two fundamental considerations.

First is the knowledge that agricultural chemicals and bio-pesticides will remain
essential tools to control pests for the foreseeable future. They will continue to be
needed to protect our food supply from insect, disease and weed pests.

Second, our public laws governing pesticide policy are fundamentally sound and
protective of public health and the environment. While it is always prudent to seek
refinements where known problems exist, it should be done with a clear purpose,
intent and design. There is not a need for drastic reform, rather changes should be
reasoned and deliberate. Your approach should be laser-like in its focus.

The Administration bill proposes a major overhaul of FIFRA with virtually no jus-
tification for many of the proposed changes. Among the changes are the elimination
of benefits consideration, limits on public participation rights, new arbitrary author-
ity to phaseout pesticides, and the establishment of new enforcement authorities,
such as citizen suits and the elimination of the first offense warning to farmers.
Many of these proposals are excessive and punitive in their design.

In contrast, the need to replace the Delaney clause with a single, flexible standard
of negligible risk is clear and widely acknowledged. However, the administration
has proposed a similarly rigid and arbitrary safety standard to replace it. It further
proposes to reevaluate tolerances on a schedule that is inconsistent with the rereg-
istration schedule required by this Committee in the 1988 FIFRA amendments. This
makes no sense and will serve only to increase the costs and pressures against man-
ufacturing a product. The effect will be to accelerate the rapidly declining number
of pesticide options currently available to farmers. This proposal goes well beyond
the reforms to the tolerance setting process recommended by the National Academy
of Sciences in its 1987 report Regulating Pesticides in Food.

EPA has chosen to place the burden and responsibility for action squarely on Con-
gress, to avoid the potentially harsh effects of a strict policy application of the
Delaney clause stemming from the Ninth Circuit Court Decision in Les. v. Reilly.
While we agree that clearly targeted and reasonable legislation is the best way to
address these issues, the Agency has chosen to ignore otner nonlegislative remedies
that could avoid or soften the impact on farmers and consumers. In fact, it has
taken every action to increase the potentially harsh economic impact upon the farm
community in order to create pressure on Congress to reform the law. We believe
this to be a particularly unnecessary and irresponsible action with unknown con-
sequences to agricultural producers.

The impacts of Les vs. Reilly case and the Delaney clause should and can be
avoided. Neither farmers nor consumers will benefit from the "train-wreck" ap-
proach to policy that is currently being pursued.
Thank you for the opportunity to comment.

Appendix 1

U.S. Agricultural Crop Protection Product Use From 1964 to 1993

On Major Crops

Year

1964

1966

1971

1976

1982

1990

1991

1992

1993

klilUan Pounds Active Ingredient

HERBICIDES

Corn

26.5

46.0

101.1

207.1

243.4

217.2

189.10

199.10

181.90

Wheat

9.2

8.3

11.6

21.9

18.1

11.8

9.90

12.60

14.20

Kc*

2.8

8.0

8.6

14.1

9.7

10.40

11.30

11.30 •

Soybean!

4J2

10.4

36.5

81.1

127.0

74.3

63.10

68.60

67.10

Subtotal

38.9

67.6

167i

318.6

402.6

313.0

272.60

281.60

264.50

Other Herbicides

31.6

33.7

66.9

55.3

63.0

63.0*

63.00 •

53.00 •

Total Herbiddee

70.S

101.2

213.1

373.9

466.6

366.0

325.60

334.50

317.50

INSECTICIDES

Com

16.7

23.6

26.6

32.0

30.1

23.3

20.90

18.40

16.60

Wheat

0.9

1.7

7.2

2.6

0.0 ••

0.16

0.90

0.12

Rice

0.3

1.0

0.6

0.1

0.16

0.09

0.09 •

Soybean*

6.0

3.2

6.6

7.9

11.1

0.0"

0.37

0.13

0.31

Subtotal

20.7

28.0

33.8

47.6

44.4

23.4

21.68

19.52

17.12

Cotton Ineecticidefl

78.0

64.9

73.4

64.1

16.9

IBS'

6.30

11.00

USO

Other Ineectiddei

18.0

16.3

20.7

18.6

9S*

9.90 •

9.90*

Total Inaectiddes

116.7

108.2

127.9

130.3

71.2

60.2

37.78

40.42

38.92

ALL FUNGICIDES

5.8

6.0

6.4

8.1

6.6

6.6 •

6.60*

6.60'

ALL OTHER PESTICIDE

31.7

36.7

29.8

36.3

24.3

24.3*

24.30*

24.30 •

US. 'IX/rAL

224.7

261.1

377.2

647.6

667.7

447.1

394.18

406.82

387.32

* Auumed to stay the eame aa in pr*vioua year becauae ftill data was not available for indicatsd year.

** Some inaectiddes were used, but no amount* were reported by the National Agricultural Statistics Service because
those inaectiddes were used on less than one percent of the acres plantad.

Sources: USDA ERS Report #622 and USDA/NASS reports "Agricultural
Chemical Usage, Field Crops Summary' for 1990, 1991, 1992, & 1993.

plNpesttren

Total Insect
Control Products

1S0r

100-

Mil.
lbs.
A.I.

76 82 90 93
Year

Weed Control Products
for C, W, R, Sb

76 82 90 93
Year

U.S. Total Crop
Protection Product Use

78 82 90 93

Compiled by Public Pohcy Division. American Farm Bureau Federation, April, 1994

Ralph Engel

My name is Ralph Engel. I am president of the Chemical Specialties Manufac-
tures Association (CSMA) located at 1913 Eye Street, Northwest, Washington, DC.

CSMA has membership of some 440 firms engaged in the manufacture, formula-
tion, distribution and sale of pesticides, antimicrooial products, automotive chemi-
cals, detergents and cleaning compounds and polishes and floor finishes for house-
hold, institutional and industrial use. A significant number of these products have
pesticidal claims and are therefore subject to EPA jurisdiction pursuant to the re-
quirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

Specifically, CSMA represents the nonagricultural pesticide industry, including
disinfectants and sanitizers, home, lawn and garden pesticides and a wide variety
of pesticides for home, industrial and institutional use. Our testimony today focuses
on three areas: The Clinton Proposal, antimicrobial products and other issues affect-
ing the pesticide registration process.

THE CLINTON PROPOSAL

Mr. Chairman, at the outset I want to note that the Clinton administration has
expended considerable effort in assembling a comprehensive FIFRA and Federal
Food, Drug and Cosmetic Act (FFDCA) reform package. There are difficult public
policy questions addressed in this package and the administration's willingness to
engage these issues is to be recognized.

Having said that, the chemical specialties industry cannot support the Clinton
legislation and feels that it is not the balanced Middle of the road" proposal that
its proponents would have you believe.

We wish to note that over the past few years, the Environmental Protection Agen-
cy (EPA) has expressed concern over what it considers to be the cumbersome and
time-consuming process required to cancel or suspend a registration. CSMA under-
stands the Agency's concern and believes it must be provioed the tools to promptly
address pesticides which pose an unreasonable adverse effect to human health or
the environment. We also believe that the continued safeguards afforded through
administrative adjudicatory hearings are in fact absolutely necessary and proper.
This process ensures an aaec^uate chance for rebuttal by the registrants as well as
a proper forum for consideration of all relevant factors for cancellation or suspension
of a pesticide.

CSMA will continue to objectively look at any reasonable proposal proffered by
EPA and others concerning tnis issue but remains committed to maintaming appro-
priate procedural safeguards. Unfortunately, many of the provisions in the Clmton
Package attempt to circumvent administrative protections. Accordingly, we in the
chemical specialties industry have very serious concerns with the legislation. Among
these concerns are:

Elimination of Benefits Considerations. The administration has essentially pro-
posed the phase-out and elimination of benefits considerations in registration, sus-
pension, and cancellation decisions over a period of 10 years. FIFRA is the last
major environmental statute which provides for a risk-benefit standard. Flexible
consideration of benefits in these decisions is consistent with the FIFRA's societal
risk-benefit requirements and is essential to preserving EPA's ability to take into
account the value of a pesticide in determining whether or not to register the prod-
uct or to let stand an existing registration.

In fact, an analysis of benefits of such products as antimicrobial which provide
public health benefits is a legitimate and important consideration which must be
preserved in the regulatory process. Antimicrobial pesticides (disinfectants,
sterilants, industrial biocides) account for approximately 30 percent of all active in-
gredients and products registered under Fn-liA. These pesticides provide substan-
tial public health benefits by preventing or destroying bacteria, fungi, viruses and
other dangerous microorganisms (legionella, salmonella, etc.). Preserving the consid-
eration of those health benefits is absolutely critical to the public health and to this
industry. Dropping this factor from the regulatory process would be a disservice to
the public and would actually weaken protections tar the public presently afforded
under FIFRA.

The administration's proposed elimination of benefits considerations is inconsist-
ent with the fundamental goals of its own Executive Orders 12866 on Regulatory
Reform which directs Federal agencies to consider the costs and benefits of available
regulatory choices and to select approaches that "maximize net benefits" to society.
Specifically, Executive Order 12866 signed by President Clinton on September 30,
1993, requires any agency developing a regulation to: 1) assess both the cost and
benefits of the intended regulation and proposed and adopt it only if its benefits jus-
tify its costs, 2) base its decisions on the best reasonable scientific, technical, and

economic information, 3) identify and assess alternative forms of regulation,
4) avoid duplicative regulations, and 5) tailor it regulations to be the least burden-
some on society. We submit that elimination of benefits considerations clearly vio-
lates this Order and on this basis alone should not be included in any FIFRA legis-
lative package.

Rigid Negligible Risk Standard. The narrative standard "reasonable certainty of
no harm" as advocated by EPA is actually severely restricted by a statutorily pre-
scribed numerical margin of safety (lxlO~^) and very conservative exposure as-
sumptions, particularly for children and infants. CSMA would continue to support
a narrative definition of "negligible risk" consistent with present risk ranges
(1x10"' to 1x10"^) used by EPA, FDA, and other Federal agencies. The risk assess-
ment process, for cancer and noncancer risks, should not be prescribed in statute;
it should instead provide EPA with appropriate scientific flexibility and discretion.

Phase - Down f Phase -Out. The administration proposal gives EPA authority to "re-
strict, reduce, or eliminate" the use of a pesticide where "credible scientific evidence
indicates that the use of the pesticide is reasonably likely to pose a significant risk
to humans or the environment." This authority would accelerate the extinction of
the FIFRA cancellation process by encouraging EPA to limit or ban the use of a pes-
ticide based upon a diminished scientific threshold.

The proposed standard itself is overly broad and would result in a reduction in
the use oi appropriate scientific standards to make regulatory decisions. Moreover,
data upon which the decision would be based would not have undergone outside sci-
entific peer review. The due process protections under FEFRA's cancellation process
would be eliminated. Phase-out/Phase-down actions would severely damage the af-
fected consumer products with adverse publicity, from which it would be difficult to
recover even if it were later determined that the Agency was in error. Such actions
would be grossly unfair and are not needed in view of current protections which
mandate that regulatory actions be predicated on good science.

Fees. One year ago, EPA testified that it needed $20 million through 1997 in new
fees to complete its FIFRA 1988 reregistration mandates. Today, the administration
outlined its revised fees proposal which now calls for more than $60 million through
1999 in three categories (maintenance fee extension, a $750 per product registration
fee, and new active ingredient reregistration fees).

Let me simply emphasize that this subcommittee and the Congress should with-
hold assessing any additional fees on registrants, or granting any additional fee au-
thority to EPA pending a thorough review of the registration and reregistration pro-
grams. Such a review should include an examination of the funds collected and uti-
lized in both programs thus far and a specific documented accounting of the use of
fees collected in previous years.

EPA Assistant Administrator Goldman's recent decision to contract with an out-
side management consultant to give her an operational assessment of Ofiice of Pre-
vention, Pesticides and Toxic Substances (OPPTS) is a courageous and valuable step
in the right direction. That outside management review must contain a serious fi-
nancial audit component. We look forward to working with EPA and the manage-
ment consultants on this, and related issues.

Reduced Risk Pesticides. CSMA and the chemical specialties industry support the
goal of encouraging the development and production of pesticides presenting lower
risks than those presently on tne market. We believe, however, that if the registra-
tion process itself were functioning properly, much of EPA's "safer pesticides policy"
would not be needed.

Frankly, we fail to understand why EPA is posturing itself to take on the creation
of yet another manpower intensive project to catapult, perhaps wrongfully, some ap-

F)lications for registrations of pesticide actives ana products ahead oi others (risking
itigation in the process) when the competitive market place would accomplish this
very same goal if the Agency would streamline the unnecessarily burdensome and
often nonfunctioning registration program. For example, in the antimicrobial sec-
tor— with generally low risk/low exposure pesticides being used indoors — only eight
active ingredients have been registered in the past 10 years (6.5 percent of the 127
new active ingredients registered in the last 10 years).

Faced with virtually no prospect of attaining registration in a useable timeframe,
companies have significantly restricted research and development activity on new
antimicrobials. These delays hinder market introduction of new antimicrobial active
ingredients and products posing even lower risks and providing greater efficacy than
those chemicals presently in use. Similar problems with the registration process in
other segments of the pesticide industry have also reduced research in new chemi-
cals and nave stymied the competitive marketplace.

Finally, the Clinton bill authorizes a cooperative agreement program under which
the Federal Government would make grants to private groups, institutions, and in-
dividuals pursing reduced pesticide use. The establishment, at this time, of a new
Federal grant program for this purpose, seems at best out of place given the inter-
nal problems with Office of Pesticide Program's (OPPs) registration system which
demand attention.

Label Call-in. The administration proposes a new Label Call-in Authority which
would allow EPA through a simple notice procedure to require changes in the "label-
ing, packaging, or composition of the pesticide." The threshold to be met bv the Ad-
ministrator before taking such action is minimal; The Administrator need only de-
termine that "the risks associated with the use of a pesticide can be reduced." In
case of noncompliance, suspension without hearing is authorized and recalls and
compensation can be ordered by the Agency.

Since pesticide use of any kind will generally involve some level of risk, this provi-
sion would grant the Administrator broad authority to delete or restrict pesticide
use which EPA has explicitly previously approved as being within an acceptable
negligible risk range.

The Agency womd be under no obligation to demonstrate an "imminent hazard"
or even an adverse eflect on man or the environment but merely that risks can be
reduced. The Label Call-in procedure outlined in the bill affords the registrant scant
due process protections. This provision is thus a further method to reduce due proc-
ess and fairness in the regulatory process and must therefore be rejected.

Export Restrictions. CSMA supports a ban on the export of pesticides which have
been suspended or canceled due to human health concerns. The Clinton bill appears
to include nonfood use pesticides in its "Circle of Poison" provision, allowing only
for an exemption by the EPA Administrator on a case-by-case basis. This is ineffi-
cient and unnecessary to address the stated issue of concern — that is dietary expo-
sure from pesticide residue in or on imported foods, nonfood use pesticides should
be specifically exempt from this provision.

Citizen Suits. The legislation would authorize any person to bring a Federal law-
suit against EPA or a pesticide manufacturer for any alleged FIFRA violation, be
it statutory or regulatory in nature. The consequences of this new authority are like-
ly to be expanded and frequent, frivolous litigation tying up Federal courts and con-
fusing EPA enforcement priorities at large cost to producers and ultimately consum-
ers is a certainty. The bill's whistle-blower provision would further exacerbate these
concerns. With all the regulatory restrictive provisions built into the EPA Pesticide
Program, this provision is unnecessary and will foster further delays in research
and the marketing of pesticide products.

Pesticide Recordkeeping. The bill greatly expands FIFRA recordkeeping require-
ments by moving from "certified and individual applicators" to all "pesticide and in-
dividual users." This a potentially costly and burdensome new requirement with out
any corresponding recognizable environmental or public health benefit. It should be
deleted.

ANTIMICROBIAL REGISTRATION REFORM

Mr Chairman, CSMA has for the past 18 months worked with the Chemical Man-
ufacturers Association (CMA), the Soap and Detergent Association (SDA), and the
International Sanitary and Supply Association (ISSA) in a coalition known as the
Antimicrobial Industry Coalition (AIC). We have demonstrated the severe problems
which plague EPA's pesticide registration program. We have put forward a legisla-
tive proposal which would streamline the antimicrobial registration process without
compromising the integrity of scientific review or public health. Many of the ideas
contained in the AIC legislation, in fact, are reasonably consistent with the underly-
ing principles of Assistant Administrator Goldman's own streamlining effort now
underway at the Agency, and we are actively engaged in a dialogue with her staff.

The need for thislegislation became apparent to us as a result of the unacceptable
backlog in antimicrobial applications pending within the Agency with little or no
chance to evolve within a reasonable time. The extent of paralysis became evident
when it came to light that only eight new antimicrobial active ingredients have been
registered by EPA within the last 10 years; while approximately 120 new
nonantimicrobial active ingredients were registered for use in other types of pes-
ticide products. This is not to indicate that this latter figure itself is reasonable but
merely shows the problem facing the antimicrobial active ingredient producers.

The problem, however, also extends into end-use products where applications re-
main locked up within the Agency for unreasonable periods of time and the expe-
dited review provisions of the 1988 amendments remain largely dysfunctional. With

little aspect of obtaining registrations within a reasonable time period, new research
and development activity on antimicrobials has been severely curtailed. The result
is that the use of new antimicrobial active ingredients in formulated products which
may pose reduced risks as advocated by EPA are not progressing through the pipe-
line to the end-use consumer. Thus, as we have repeatedly said in every hearing
for the past 15 years, something must be done about the registration process within
EPA. If the Agency really wants to spur on the introduction of products posing re-
duced risks, then it must address this registration process. Its inability to do this
over the last 15 years, despite the 1988 amendments to FIFRA, dictate that this
subcommittee move forward and address this problem now in new legislation.

Among the most serious problems with in Ofiice of Pesticide Programs
antimicrobial registration process are: 1) inadequate stalling and resources, 2) un-
necessary, repetitive reviews of staff actions, 3) EPA's low priority treatment of
antimicrobial applications, and 4) shifting data requirements which change without
scientific justification. Our understanding is that the Registration Division's
Antimicrobial Branch has had only two product managers attempting to handle
2600 product registrations and amendments each, while nonantimicrobial product
managers handle approximately 1500 product decisions. In short, EPA has not as-
signed sufficient staff personnel to handle the volume of applications and amend-
ments for these products in a reasonable time period.

With respect to staff priorities, EPA has focused its resources on the registration
and reregistration of agricultural chemicals which the Agency has concluded pre-
sents the greatest public health and environmental risks and similarly the greatest
opportunity for risk reductions. Under this system, applications and amendments
for antimicrobial products experience unreasonable delays awaiting EPA staff ac-
tion. Once actions are finally taken the system is plagued by consecutive reviews
by several layers of EPA management. Finally, once actions have been taken, appli-
cants often find themselves caught in the dilemma of having data requirements
changed by EPA staff without scientific justification with additional studies de-
manded which in many cases, are irrelevant to a product's proposed use. Reg-
istrants experience unconscionable delays as a result of EPA request for clarifica-
tion, raw data, and imposition of additional data requirements. All of these factors
combine to keep these products from the marketplace because of failure to obtain
registration witnin a reasonable timeperiod. The irony of the situation is that many
of the products have cleaning and detergent capabilities which, absent the disinfect-
ant claim, are available without any prior approval from EPA for sale to consumers.

The Antimicrobial Industry Coalition bill seeks to address these shortcomings by
significantly streamlining the registration process by establishing:

— A statutory definition for antimicrobial pesticides which appropriately distin-
guishes the unique uses and benefits of anitimicrobials from those of other pes-
ticides;

— A new division of antimicrobial pesticides to clarify, improve and consolidate
regulatory requirements. This division would be provided with staff and resources
adequate to permit timely and consistent decisionmaking on the large volume of
antimicrobial registration applications. These resource allocations, would more equi-
tably reflect the fees contribution of the antimicrobial pesticide industry;

— A registration process for antimicrobial pesticides recognizing unique uses,
limited risks and societal benefits of this pesticide class without compromising sci-
entific review of data necessary to maintain or establish public health and environ-
mental standards;

— A process emphasizing from-end agreement between the registrants and EPA
concerning data requirements and schedules for decisionmaking. This would provide
certainty and finality and would be subject to EPA dispute resolution procedures
and judicial enforcement;

— A regulatory program whereby applicants can certify compliance with specified
EPA requirements or in some cases notify EPA of compliance thus freeing EPA per-
sonnel to address registration health related reviews.

I wish to emphasis the need for inclusion of antimicrobial registration reform
amendments to FIFRA in whatever markup vehicle is chosen. CSMA believes these
problems need to be addressed in 1994, whether or not comprehensive food safety
legislation is completed this year.

OTHER AREAS NEEDING SUBCOMMITTEE ATTENTION

There are a few other areas in the regulation of pesticides which warrant sub-
committee attention. These points and suggested remedies are as follows:

Expedited Review. The 1998 FIFRA amendments, under section 3(cX3)(B) created
and expedited review" for registration applications which are identical, or substan-
tially similar, to a currently registered pesticide product. FIFRA now requires that
the applicant receive notification from the Agency as to whether or not the applica-
tion is complete within 45 days and subsequent to such determination, that these
applications be approved or denied within 90 days. This process is not working and
thus even simple label changes and applications to register products which are iden-
tical to other previously registered products can take over a year to complete. Con-
gress created expedited review and specifically earmarked $2 million to eliminate
registration backlogs in 1988. Yet nearly 6 years later, EPA is still not utilizing this
tool.

CSMA recommends that the subcommittee legislatively compel EPA to implement
a procedure whereby under FIFRA section (3)(c)(3XB)(ii)(I), any applicant who does
not receive notification within 45 days after EPA's receipt of an application as to
whether or not the application is or is not complete, then such application must be
deemed by EPA as complete. Furthermore, in tne event that the applicant does not
receive notification as to the acceptance or denial of the application within 90 days
after receipt by EPA of the complete application, then pursuant to FIFRA section
(3)(c)(3XBXii)(II), such application must be deemed by EPA as approved.

Under this suggested procedure, which follows the times mandated by Congress
under the current law, EPA should be permitted to only refuse to issue and ap-
proved application after expiration of 90 days if the Agency, within 15 days, was
planning to issue a Notice of Intent to Suspend or Cancel the active ingredient reg-
istration for the same uses. The deadlines set forth could not be extended by EPA
for reasons having to do with administrative workload. Furthermore, in the event
of a new registrant wishes to obtain a stamped approved label for use in the States,
it could do so by merely having an agent present such label for appropriate stamp-
ing at an EPA designated office.

Under this suggested procedure, hundreds of applications for products which are
similar or identical to those already registered and on the market would move
quickly. Implementation of this procedure would therefore greatly assist in breaking
the EPA registration log jam which is precisely what this subcommittee and Con-
gress directed EPA to accomplish nearly 6 years ago.

Certification and Training. In past FIFRA hearings, there has been some discus-
sion concerning certification and training requirements and whether these should
be extended to persons using general use pesticides. Some interests have advocated
that commercial application of any pesticide should be made subject to certification
and training standards even if the pesticide is applied incidental to employment.

Implementation of such a policy would be folly and would require certification and
special training for persons such as:

— A busboy in a restaurant who wipes table tops with a disinfectant cleaner;

— A school custodian who cleans the rest rooms with a tile and bowl cleaner;

— A building superintendent who eradicated a hornets nest with general use
wasp and hornet spray;

— A nurse or doctor using a hospital disinfectant; or even a housekeeper who
freshens up a room with a disinfectant spray.

In each of these instances, the pesticide applied is a general use product under
section 3 of FIFRA, registered as such because EPA has reviewed it and determined
that it will not cause unreasonable adverse effects to man or the environment. Such
factors as low toxicity, when compared to other pesticides that may be classified as
restricted use, are already taken into account. EPA also approves the label and spe-
cific directions for use.

Consumers of general use pesticides can be expected to use the products safely
in accordance with directions without costly and burdensome training and certifi-
cation. It is not necessary or appropriate to burden the public with such require-
ments, which would limit an individual's ability to quickly, easily, and inexpensively
solve pest problems affecting public health and safety.

We Delieve that certification and training requirements are appropriate for "com-
mercial applicators" who apply pesticides as the principal part of their business and
we believe any legislation concerning such certification and training should reflect
this distinction.

Conclusion

I want to close by emphasizing the need for consideration of our suggested
changes and inclusion of antimicrobial registration reform amendments to FIFRA.

We believe that these problems can and need to be addressed in 1994, whether or
not comprehensive food safety legislation is completed this year.

Christian Schlect and Mark Maslyn

The Minor Crop Farmer Alliance (MCFA or Alliance) comprises 134 local, regional
and national commodity organizations interested in solutions to the minor use issue.

The Alliance, representing organizations that grow and market agricultural com-
modities, was formed in November 1991 to address legislative and administrative
policies to ensure the continued availability of crop protection chemicals for minor
use crops. Although the Alliance's focus is on addressing proposed changes to the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the MCFA also ad-
dresses other issues to achieve its objectives. These include funding for agricultural
research, harmonized international agricultural chemical standards, support for in-
tegrated pest management, and any needed reorganization of existing Federal de-
partments or agencies to make them more efficient in addressing crop protection is-
sues.

In summary, when we talk about the minor use pesticide issue, what is meant
is the loss of crop protection tools, not for safety reasons but for economic reasons.
Basically, the costs of generating data to satisfy the U.S. Environmental Protection
Agency's (USEPA) requirements for either registering or re-registering crop protec-
tion tools for a particular use outweighs the return that the agricultural chemical
manufacturer expects from the sale of that product. For example, if it costs $100,000
to develop data to support a particular minor use pesticide and sales for that use
are $75,000, clearly there is an economic disincentive for the manufacturer to de-
velop the required data. This problem applies to both obtaining registrations for new
uses and maintaining existing registrations. Over the past 5 years, this issue has
become particularly acute.

According to the National Association of State Departments of Agriculture
(NASDA), a member of the AlUance, the lack of sufficient minor crop pesticides has
two added impacts. The first impact is on State resources, in that State personnel
must be devoted to the development of requests for section 24c and section 18 ex-
eniptions, most of which are in response to minor crop pest control needs.

The second impact is on pesticide investigation and enforcement efforts. States
must pursue cases of label violation where the pesticide is not registered on the crop
subject to the investigation, but is labeled for use on similar crops. Civil penalties
are imposed for violations such as the application of Ronilan on blackberries, al-
though it is labeled on strawberries and raspberries, or the application of Lorox on
celery, which is labeled for celery application east of the rocky mountains only. The
end result is that crops are embargoed and civil penalties can be levied although
the violation is primarily technical in nature. In most instances, economics is the
reason why a product is not on the label.

We would like to focus now on the legislative solutions to the minor use pesticide
issue which we believe can and must be enacted this year.

House bill H.R. 967 by Congressman de la Garza, Roberts, Stenholm and Smith
has 128 cosponsors. The companion Senate bill, S. 985 by Senators Inouye and
Lugar has 43 cosponsors.

The Minor Crop Pesticides Act would essentially:

(1) Define minor uses to include those noneconomic uses involved on commercial
agricultural crops or sites, on animals, or for public health.

(2) It would extend exclusive data protection for 10 years when such data relate
solely to a minor use pesticides. For instance, when a manufacturer registers a pes-
ticide for the first time, EPA is required to maintain their data in confidence. Com-
petitors can rely on those data only after a certain time period, i.e., after 10 years
have elapsed, or if the original data submitter voluntarily allows them access. The
legislation would provide additional protection for data relating to minor use pes-
ticide information.

(3) The legislation would extend the time for submission of residue chemistry
data for minor use pesticides for 2 years after the final deadline for submission of
data for the major pesticide uses. Basically, this would establish two categories of
pesticide information, one for major uses and the other for the minor uses. The pes-
ticide manufacturers have indicated that it would be beneficial if they would be al-
lowed to complete the re-registration process by developing the data necessary to
support their major uses first, and then subsequently supply the data necessary for
supporting the remaining minor uses.

(4) The legislation would expedite minor use pesticide registration decisions in
three instances: (1) if there are three or more minor pesticide uses per mmor use,
(2) if the use would serve as a replacement for a use that has been cancelled within
5 years of the application, or (3) the use would avoid the re-issuance of an emer-
gency exemption. I think that makes sound public sense. If the USEPA is going to
cancel a particular chemical or if the USEPA, which has been under much criticism
lately for continually issuing emergency exemptions for pesticide uses, can get uses
addressing those circumstances registered, registration applications for those uses
should receive a priority.

(5) The legislation would also authorize the conditional registration of minor
pesticide uses that were previously cancelled or proposed for cancellation or deletion
after December 24, 1988. Essentially this would return to the market for a period
of time certain chemicals that were previously cancelled where a clear determina-
tion that no safety triggers were exceeded can be made.

(6) The legislation would also provide a temporary extension of unsupported
minor pesticide uses to the final deadline for submission of data for uses being sup-
ported. This is a transition period provision. In other words, what is needed in the
farmer community is early notice that a particular chemical is being eliminated.
Manufacturers have a reason not to provide that notice. When pesticide manufactur-
ers decide not defend a particular pesticide use, sometimes they wait until they sub-
mit their voluntary cancellation request to the Agency prior to notifying user com-
munity of the loss of a use. There needs to be a better communication system, a
warning system that identifies when a particular use is going to be lost at the earli-
est possible time.

(7) The legislation would also establish USEPA and USDA minor pesticide use
programs. It is important that those two agencies cooperate. As strange as it
sounds, in Washington, D.C., the USDA and USEPA may not always talk to one
another. As a matter of fact, often they talk at one another, if they talk at all, and
that has to change. This is not good for farmers or for the regulated community or
any other parts of our society. Both Federal entities have an opportunity to do great
good or great harm. We would suggest that they focus on doing the greater good,
and one way they're going to achieve that is by coordinating their efforts in the pes-
ticide area.

(8) The legislation would also provide a matching fund for data development
with industry and the USDA. If minor use data are required, under a matching pro-
gram a grower organization, for example, could put up half the money with the Gov-
ernment putting up the other half. The growers would then repay the Government
share over a longer period of time, e.g., 10 or 20 years.

(9) The Minor Crop Farmer Alliance also wants an increase in ftindine for the
IR^ program and have additional funds devoted to the IPM programs. We think
these are very important.

(10) We would also support expedited treatment of biologicals and so-called re-
duced risk chemicals.

As a solution to the minor use issue, some have suggested simply increasing ex-
emptions from data submission for a number of these minor uses. If EPA does not
require so much data, the potential economic impact would be addressed. However,
pesticide uses associated with fruits and vegetables are those that are in the public's
mind. If a residue problem comes up, you normally don't hear about it in reference
to Christmas trees. You hear about it developing on fruits, vegetables and specialty
crop foods that people typically consume. The publicity is particularly intense if it
involves children. The Alliance supports those actions necessary to protect the
health and safety of our food supply and will work with the administration to de-
velop a comprehensive approach necessary to assure the consuming public of the
safety products we grow.

The minor use provisions in the administration's proposed pesticide/food safety re-
form legislation are a major step forward. We are encouraged by the administra-
tion's recognition of the minor use problem by including many of the provisions of
H.R. 967 and S. 985 in its proposed legislation.

We look forward to continued discussions with the Congress and the administra-
tion regarding these provisions. It is imperative that reasonable changes in the proc-
ess for minor uses be made this year.

Attached to our testimony is a revised chart comparing the Minor Crop Farmer
Alliance (MCFA) proposals contained in H.R. 967 and S. 985 with the administra-
tion's proposals contained in H.R. 4329 and S. 2050. ^^ Based upon a review of the
administration's proposals, the following comments are offered for your consider-
ation:

1. Section 10 Minor Use of Pesticides (a) Definition, p. 74. The Agency has estab-
lished criteria by which a pesticide use is automatically considered a minor use (a
"bright line"). There are problems with the criteria. First it does not relate to use
of a pesticide on a site, on an animal or for the protection of public health. Those
uses would have to qualify under the second part of the definition, namely that the
use does not provide sufficient economic incentive for its maintenance. It is rec-
ommended that the criteria be revised to also create a "bright line" to address sites,
animals and to protect the public health. Additionally, the farm gate value or poten-
tial return to the crop on an annual basis should be dropped from the definition.
It simply is an unnecessary restriction. Further, the higher this value is in relation
to the acreage of production, the greater the negative impact on the availability of
crop protection tools due to liability concerns.

2. Sec. 10 Minor Use of Pesticides (a) Definition, p. 74. The second part of the def-
inition of a minor use is an economic definition i.e., the use does not provide sufii-
cient economic incentive for its maintenance. However, the definition adds three ad-
ditional criteria, any one of which most also be met namely, (a) there are insufTi-
cient eflicacious alternative registered pesticides available for the use, (b) the alter-
natives to the pesticide pose greater risks to the environment or human health, or
(c) the pesticide plays a significant part in managing pest resistance. It is rec-
ommended that these three criteria be eliminated. If a pesticide use is shown to be
noneconomic, it should qualify as a minor use. The minor use problem is an eco-
nomic problem. It should not be saddled with additional unnecessary limiting cri-
teria. For example, the criteria that there are insufficient efficacious alternative reg-
istered pesticide products available perpetuates making just one potential crop pro-
tection tool available for a minor use. Minor uses should not be limited to one pes-
ticide. This can place the affected commodity at risk particularly if questions about
that single pesticide ever arise jeopardizing the continued use of the pesticide.

If the criteria are to remain, another alternative criteria should be added, namely
that the pesticide is included as part of an Integrated Pest management ("EPM")
program.

3. Section 9 Reduced Risk Pesticides, (g) Use of Research Funds, p. 71. This provi-
sion would authorize use of grower funds for pesticide research and technology
transfer plans. However an exclusion exists namely "[n]o moneys under this section
may be made available to persons directly or indirectly engaged in the registration
of pesticides under this Act for profit." It is not clear what "directly or indirectly"
mean. There may be grower associations or organizations which may register pes-
ticides for profit as a small adjunct to the traditional nonprofit activities of the orga-
nization. In any event, it is suggested that this sentence be amended to read "[n]o
moneys under this section may be made available to persons whose business sub-
stantially involves the sale of pesticides for profit." This should eliminate chemical
companies which are the entities at which the provision is presumably aimed.

4. Section 10 Minor Use of Pesticides (b) Adequate Time For Submission of Minor
Use Data, p. 75. The first sentence of subparagraph (n)(l) should be revised to indi-
cate that the Administrator, on the request of a registrant "or at the request of a
user with the consent of the registrant," may delay action to delete a minor food
or feed use. This would provide user community greater direct involvement in the
extension process.

In addition to the foregoing, consideration should be given to requesting Congress
to modify the administration's bill to add a number of provisions included in
H.R. 967 and S. 985 which are not yet part of the administration proposals. In par-
ticular, the proposed grant program and the establishment of minor use programs
within both EPA and USDA should be included by the Congress.

In conclusion, Mr. Chairman, we believe that the differences between S. 985 and
the minor use provisions of S. 2050 the Administration bill, quickly resolvable. We
believe this issue can and should be resolved this year and we look forward to work-
ing with you and Chairman de la Garza to enact minor use legislation this year.

*^See page 91.

OUTLINE OF MINOR CROP PESTICIDES ACT (MCFA)
WITH ADMINISTRATION PROPOSALS

MCFA

ADMINISTRATION

1. Minor use defined and based on lack of
economic incentive to maintain the use.

1. Minor use defined both as a "bright line" and
as an economic problem. The "bright line"
definition includes qualifiers i.e. To
automatically be considered a minor use, the
total acreage of the crop must be less than
300,000 acres and the average annual
production value of the crop must be less than
$500,000,000. Another way to qualify as a
minor use is to demonstrate that the use does
not provide sufficient economic incentive to
support the use. In addition, in such
circumstance, one of three other criteria must
be met i.e. (a) lack of efficacious alternatives,
(b) alternatives pose greater risk to the
environment or public health or (c) the
pesticide has a significant role in managing pest
resistance.

2. Minor use includes use on animals,

commercial agricultural crop or site, or for
public health.

2. Minor use includes use on a commercial
agricultural crop, on an animal, or for the
protection of public health.

3. Exclusive data use protection extended for
10 years if such data relate solely to a
minor use. Includes new registrations and
existing registrations.

3. Extend exclusive data use protection for two
years for those pesticides for which the
Administrator has approved at least three minor
uses prior to the expiration of the original
exclusive use period, i.e. within 10 years of the
date the first use of the chemical was
registered.

4. Extend time for submission of residue
chemistry data for minor uses for 2 years
after final deadline for submission of data
for other uses.

4, Extend the time for development of residue
chemistry data for minor uses until the last
study date for the chemical.

5. Administrator may waive minor use data
requirements in certain circumstances.

5. Not discussed. (Essentially in current
regulations).

MCFA

ADMINISTRATION

6. Expedite minor use registration if active
ingredient is to be registered solely for
minor use or if there's 3 or more minor
uses for every non minor use, use would
serve as a replacement for any use that has
been cancelled within 5 years of application
or minor use would avoid re-issuance of an
emergency exemption.

6. Prioritize pesticide applications as follows:

(a) those that would replace the need to issue a
§ 18 emergency exemption

(b) those that reduce risks for pesticides in a
cancellation or suspension proceeding

(d) minor use pesticides

(e) other applications

7. Conditional registrations for minor uses
shall be granted in certain circumstances.

7. Not directly discussed.

8. Administrator may conditionally register
minor uses that were previously cancelled,
proposed for cancellation or deleted after
December 24, 1988.

8. Not discussed.

9. Temporary extension of unsupported minor
uses to final deadline for submission of data
for uses being supported.

9. Allow minor uses to continue until the due date
of the final study required in the re-registration
process.

10. Utilizing data for voluntarily cancelled
chemicals.

10. Not discussed.

1 1 . Establish EPA minor use program and
USDA minor use program.

11. Not discussed. (USDA reorganization plan
would include parts of the USDA minor use
program).

12. Matching fund for data development with
industry and USDA.

12. Not discussed.

\32082\010\80STAJCH.001

-2-

WiUiam C. Balek

INTRODUCTION

My name is William C. Balek and I am the director of Legislative Affairs for the
International Sanitary Supply Association (ISSA). ISSA is a nonprofit trade associa-
tion comprised of over 4,000 member companies located across the Nation. The vast
majority of these companies are small businesses, 68 percent of which have annual
gross revenues of less than $2 million.

These companies manufacture and distribute a wide spectrum of institutional and
industrial cleaning and maintenance products, including antimicrobial pesticide
products such as disinfectants, sanitizers, and germicides which are regulated by
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Our membership
distributes antimicrobial pesticides for use in hospitals, nursing homes, schools, food
and beverage processing plants, hotels, restaurants, day care centers, and other in-
stitutional anci industrial establishments. As such, these products play an essential
role in maintaining public health and the quality of Hfe.

Of the many benefits of antimicrobial pesticides, none is more important than the
role played in the protection of public health. Microorganisms exist virtually every-
where. The uncontrolled growth of bacteria, fungi, viruses, and a host of other orga-
nisms would have a severe negative impact on public health as well as detrimental
economic consequences. Fortunately, this potential impact can be minimized by the
proper use of antimicrobial products.

Disinfectants, sanitizers, germicides and sterilants are antimicrobial products de-
signed specifically to control pathogenic organisms which can be harmful, even fatal,
to humans and the environment. Modern sanitation and hygienic practices are one
of the reasons for the longer life expectancies and general good health and sanitary
conditions we enjoy. A significant aspect of these practices includes the use and ap-
plication of antimicrobial pesticides.

ISSA appreciates this opportunity to testify and we thank Chairman Daschle and
the Subcommittee on Agricultural Research, Conservation, Forestiy, and General
Legislation for conducting hearings on the reauthorization of the Federal Insecti-
cide, Fungicide and Rodenticide Act (FIFRA). In our testimony here today, we would
like to address certain elements contained in S. 2050 including the fee and labeHng
provisions. In addition, we would also like to comment on improvements to the prod-
uct registration process.

PESTICIDE FEES

ISSA strongly opposes the creation of additional pesticide fees and the extension
of existing maintenance fees as contemplated by S. 2050. We ask Congress not to
grant EPA the authority to impose additional fees upon industry until the Agency
provides a detailed accounting of the revenues it collected and expended in further-
ance of the pesticide registration program. In fact the House Agriculture Sub-
committee on Department Operations and Nutrition recently rejected similar fee
provisions when it marked up its version of FIFRA legislation. Furthermore, we op-
pose any fee provisions, such as those contained in S. 2050, that do not address the
disproportionate burden placed upon small businesses.

Over the past several years, ElPA has repeatedly declared that it is experiencing
a shortfall of revenues necessary to complete its reregistration program. In fact,
such a declaration gave rise to a compromise fee package that was adopted in 1991.

In 1991, ISSA and several other trade associations negotiated a compromise on
maintenance fees with EPA that was ultimately signed into law. In essence that
compromise fee package maintained the maintenance fee at $650 for the first prod-
uct, and $1,300 for each additional product. These fees are subject to limitations.
Small businesses with 50 registered products pay no more than $38,500, while small
businesses with 51 or more products pay no more than $66,500. This fee structure
generated $15.1 million, $1.1 million more than the statutory goal of $14 million.

Once again, appearing before a joint House-Senate Congressional committee hear-
ing on September 23, 1993, EPA estimated that the current reregistration shortfall
was $20 million. The fee provisions of S. 2050 are intended to address this shortfall
by extending EPA's authority to levy maintenance fees for 2 years. In addition, S.
2050 would impose a $120,000 supplemental reregistration fee on an active ingredi-
ent registered for a major food or feed use, and a $60,000 supplemental reregistra-
tion fee for active ingredients registered for nonagricultural uses. Furthermore, S.
2050 would establish a $750 per product fee which could be adjusted by EPA to en-
sure that at least $4 million would be generated over the 4 year period following
enactment.

Based on these fee proposals, we estimate that total revenues of over $60 million
will be generated, substantially more than the $20 million shortfall declared by the
Agency. We base our estimate on the following. First, it is proposed that the mainte-
nance fee provisions be extended for 2 years. Presently, maintenance fees generate
$15.1 million per year. Extending EPA's authority to levy this fee for 2 years would
raise an additional $30.2 million.

second, the proposed supplemental reregistration fees of $120,000 and $60,000 are
set at approximately 80 percent of the original reregistration fees enacted in 1988.
When one considers that in 1989 EPA collected $35 million in reregistration fees,
we can expect to collect approximately $28 million, or roughly 80 percent of the
1989 levels. Last, the proposed product registration fee of $750 is designed to gen-
erate $4 million.

Based on these calculations, the proposed fee provisions of H.R. 4329 would gen-
erate $62.2 million, over $40 million more than EPA's estimated shortfall. This glar-
ing inconsistencv, alone, demonstrates the need for a complete explanation of ex-
penditures for tne registration and reregistration programs including expenditures
for expedited registrations {i.e., "fast track" registrations). ISSA urges Congress to
require EPA to provide a clear and detailed accounting of how moneys have been
spent since the reregistration program was created under the 1988 amendments to
FEFRA. Once we have a clear understanding of the costs and expenditures associ-
ated with the reregistration program, we can determine if there is a need to gen-
erate additional revenues. To enact fees as contemplated by S. 2050 without the
benefit of such an assessment would be premature.

Furthermore, EPA's declared need for additional revenues must also be viewed in
the context of EPA's present efforts to "reinvent" the Agency. Like all other Federal
agencies, EPA is attempting to streamline its operations to create a more effective
and efficient Agency. In essence, EPA is restructuring itself so that it can do more
with less resources. We commend EPA for these efforts, and in fact have been work-
ing with the Agency to help develop specific proposals.

EPA has responded positively to many of industry's suggestions and is proceeding
at an aggressive pace to implement various recommendations. In fact we expect
EPA to implement a number of changes within the next 4 to 6 months. For example,
the Agency is proceeding with procedures that would allow simple amendments to
product registrations to be handled by notification. The Agency is also working to
implement process improvements in regard to acute toxicity reviews and the label-
ing review process.

It is our belief that these and other proposed changes will streamline the oper-
ations of the Office of Pesticide Programs (OPP) by improving certain efficiencies
and eliminating unnecessary waste of limited Agency resources. It is likely that
many of these dianges will result in savings to the Agency. Conseauently, ISSA be-
lieves that it would be best to first evaluate the results of the administrative im-
provements EPA is attempting to implement before we assess EPA's declared need
for additional resources.

More specifically, ISSA strongly believes that it is premature to address the con-
tinuation of maintenance fees at this time. An extension of EPA's authority to levy
maintenance fees until 1999 does not have to be considered until we move closer
to that date. In fact, there will be additional opportunities to review this issue prior
to 1998 during additional FIFRA reauthorizations. At that time Congress will have
the benefit to see what impact the various streamlining reforms have had on OPP
resources, and will be in a better position to judge the need for additional resources.

Moreover, it is important to note that EPA is seeking an extension of maintenance
fees until 1999, but it is not seeking an extension of the prohibition of registration
fees during the same time period. Therefore, under S. 2050, registrants would have
to pay both maintenance fees and the new product registration fees.

The consequences of such a fee system are especially burdensome to small busi-
nesses who produce low volume antimicrobial pesticides. In effect, under S. 2050,
these companies will have to pay an annual fee of $2050 to maintain their product
registration (i.e., a $1300 maintenance fee and the proposed $750 registration fee).
To understand the true impact of this proposal we need to place it in the context
of State registration fees. It now costs well over $5,000 to register one pesticide
product in each State. Therefore, the total cost to a firm who wishes to market its
product nationally would be $7,050.

As mentioned previously, ISSA is comprised primarily of small businesses, the
majority of which generate less than $2 million per year in the sales of cleaning and
maintenance products. Furthermore, antimicrobial pesticides are produced in low
volumes. The specialty market in antimicrobial products has been successful be-
cause small formulators have been able to produce minimum quantities of
antimicrobial products for limited uses. Many oi these products generate annual

sales that are measured in the tens of thousands of dollars. These products must
pay the same fee as agricultural pesticides that generate sales in the millions of dol-
lars.

Therefore, the pesticide fee provisions of S. 2050 would have an unreasonably dis-
proportionate adverse economic impact on small formulators of antimicrobial prod-
ucts because the fees paid by these companies represent a substantially higher per-
centage of their total sales compared to larger companies. Such a fee system upsets
the competitive balance between large and small firms. Therefore, ISSA opposes any
fee system that does not take into consideration small business concerns.

ISSA encourages the Subcommittee on Agricultural Research, Conservation, for-
estry, and general Legislation to reject the fee provisions of S. 2050. In fact, the
House Agriculture Subconmiittee on Department Operations and Nutrition rejected
similar fee provisions when it completed its markup of FIFRA legislation, H.R. 1627.

LABEL CALL-IN AUTHORITY

ISSA supports the proposed language in S. 2050 that would establish a uniform
compliance date for label changes intended to reduce potential risk associated with
the use of a pesticide. However, we strongly object to the creation of new suspension
and recall authorities which would allow the Agency to take drastic action against

gesticide products sold or distributed in violation of the label call-in provisions of
. 2050.

Over the past few years, ISSA has advocated the adoption of a uniform compli-
ance date for label changes required by EPA to reduce the burden of multiple label
changes that may be reauire over the course of a year. To this end we support those
provisions in S. 2050 which would set one annual date by which registrants must
comply with EPA mandated label changes intended to reduce potential risk associ-
ated with the use of a pesticide product.

While we applaud this proposal, we believe it should be expanded upon by estab-
lishing an office within EPA that would be responsible for coordinating all EPA re-
quired label changes. ISSA believes such an office is necessary because there are
numerous offices and programs within EPA that require modification to existing
pesticide product labels, but there is no internal coordination of these various label
changes.

EPA requires, at various times, numerous amendments to existing labels. The
changes might reflect a new active ingredient, an inert or a difTerent use. Other
changes are made to incorporate a new set of directions or warnings about use or
specific health and safety mstructions. At other times, EPA may require the label
to be modified to include new instructions for proper disposal of the container. In
addition, specific programs within EPA, such as tne Label Improvement Program,
also require changes to labeling content.

In essence, many difierent offices and programs within the Agency require reg-
istrants to alter their labels. However, there is no mechanism in place through
which the Agency is able to coordinate these various label changes. As a con-
sequence, companies may modify their label to address one program's requirements,
only to find several months later that they must, once again, alter their label to
comply with another EPA requirement.

This lack of coordination is especially burdensome to ISSA members who formu-
late and distribute private label products. It is not uncommon for formulators to sell
one product under as many as 20 to 30 different private labels. Furthermore, com-
panies may have as many as 100 product registrations. As a result, one label change
required by EPA results in the printing of thousands of new labels, only to find that
another program or department requires additional changes just a short time later.
This lack of coordination often results in a company discarding thousands of dollars
in labels because they are made obsolete by another EPA directive.

Moreover, there is a distinct lack of coordination between product managers.
Label Improvement Program personnel and other EPA staff in formulating label re-

?[uirements. This internal lack of coordination often leads to conflicting instructions
rom various Agency personnel as to specific labeling language for virtually identical
products. The result can be confusing and frustrating for industry in its attempts
to comply with its labeling responsibilities.

ISSA, therefore, recommends that S. 2050 be revised to establish one office within
the Agency that would be responsible for coordinating all label changes required by
the various programs and divisions within EPA so that there is no confusion about
the necessary elements needed to comply with the various EPA required label
changes.

Despite the positive move in establishing one uniform compliance date for label
changes, ISSA takes exception with those provisions of S. 2050 that would authorize

EPA to suspend and recall pesticide products that are sold or distributed in viola-
tion of the requirements issued pursuant to the label call-in provisions of S. 2050.

Under current law, only those pesticides that are suspended or canceled for health
and safety concerns can be made subject to a mandatory EPA recall. S. 2050, as
drafted, however, would expand the scope of products which could be subject to a
mandatory recall to virtually any pesticide with any labeling violation, no matter
how minor. As a matter of policy, we should not subject a minor labeling violation
to the same penalties as those that apply to products suspended and canceled be-
cause of health and safety concerns. ISSA, therefore, encourages Members of the
subcommittee to reiect those provisions that would allow for the recall of pesticide
products for even the most minor oversights in complying with labeling directives.

For essentially the same reasons, ISSA also opposes those provisions of S. 2050
that would allow EPA to issue a suspension notice for even relatively minor inad-
vertent label violations. Under present law, EPA may issue a suspension notice only
if the Agency determines that a product poses an "imminent hazard." 8. 2050, how-
ever, would expand the Agency's authority to suspend products that had even the
most minor of labeling violations regardless as to whether it had an adverse impact
on health and safety. ISSA opposes any attempt to expand its suspension power to
cover such minor labeling violations.

IMPROVEMENTS TO EPA REGISTRATION PROCESS

EPA pesticide product registrations are not being processed in the most effective
and efficient manner. These circumstances have created a backlog of registrations
which has had a disproportionate impact upon antimicrobial products. ISSA, in con-
junction with other industry groups, has been working with EPA in developing ad-
ministrative policies which would streamline the OPP registration program. Specifi-
cally, ISSA has proposed that EPA adopt strategies that would allow the Agency
to meet the requirements of the "fast track" registration program. In addition, we
believe the notification process should be broadened to encompass relatively minor
registration activities.

Antimicrobial products have been unreasonably adversely affected by the backlog
in the EPA registration process. Disinfectants, germicides, sanitizers and other
antimicrobial products provide substantial public liealth benefits by preventing or
destroying bacteria, fungi, viruses, and other dangerous microorganisms such as
legionella and salmonella. These products play an essential role in the maintenance
of sanitary and healthful conditions in hospitals, nursing homes, schools, day care
centers, food and beverage processing plants, restaurants, hotels, and many other
institutional and industrial establishments and even private homes. In a very sub-
stantial way, these products contribute to the overall quality of life that we enjoy
today.

Despite these significant benefits, EPA assigns antimicrobial products a low prior-
ity in the registration process because of the low risk associated with these prod-
ucts. Unlike other pesticide products, antimicrobials are considered low risk for
many reasons:

1. Applications of antimicrobials are generally indoors and in very small quan-
tities, resulting in minimal exposure to the environment and man.

2. Dietary exposure is not a concern with this category of products.

3. In general, antimicrobials are formulated in a manner to provide for their safe
use by minimizing the amount of active ingredient present in the product.

4. Industrial biocides are generally used in closed or controlled systems (i.e.,
water cooling systems, or product preservation uses) which virtually eliminate risks
to human health and the environment.

As a pesticide class, antimicrobials provide substantial societal benefits while pre-
senting minimal hazards to man or the environment. Ironically, EPA's policies have
frustrated the introduction of significant new antimicrobial products. In fact, during
the past 8 years only one new antimicrobial active ingredient has been registered
by EPA. By comparison, during that same time period approximately 100 new
nonantimicrobial active ingredients were registered.

Antimicrobial pesticides account for approximately 35 percent of all active ingredi-
ents and pesticiae products currently registered under FIFRA, and generate about
$4 million in annual maintenance fees out of a total of $15 million in fees collected
annually. At the present, the EPA Registration Division's Antimicrobial Branch has
only two product managers attempting to handle 35 percent of registered active in-
gredients. The other two registration review branches handling the remaining 65
percent of registered actives and products are manned by nine product managers.
Consequently, each of the two antimicrobial product managers is responsible for

about 3,500 registrations, while each of the product managers handling other pes-
ticides are responsible for less than 1,400 registrations.

This disproportionate skewing of resources has virtually paralyzed the registra-
tion of antimicrobial products. Not only has EPA's policy thwarted the timely intro-
duction of new products and active ingredients, but it has frustrated the timely fil-
ing of minor amendments to existing registrations. A recent survey of ISSA mem-
bers reveals that registrations for minor amendments that could literally take 15
minutes to process are taking anywhere from 6 months to up to IVa years. The pri-
mary reasons for these delays as cited by survey respondents include:

1. Inadequate number of personnel.

2. EPA's claim of lost mail or paperwork requiring the need for resubmission.

3. Inconsistent requirements for labeling language and data.

One respondent pointed out that it has repeatedly taken approximately 1 year for
it to receive approval for its "me-too" antimicrobial registrations. However, the same
company has oeen able to receive approval for a nonantimicrobial product "me-too"
registration in just over 3 weeks.

These delays are not only inequitable but are also unacceptable. The EPA reg-
istration process must be improved and not continue to operate as a barrier to mar-
ket entry thereby denying the public access to better products. ISSA suggests that
Congress direct the Agency to make improvements to the "fast track" registration
program as well as expand the scope of registrations that could be handled by a no-
tification process.

FAST TRACK REGISTRATION

For the past 6 years, EPA has been attempting to implement the provisions of
the 1988 amendments to FIFRA which require the Agency to expedite me-too" reg-
istrations and other minor amendments. To date, EPA has been unsuccessful in exe-
cuting this Congressional mandate. Fast track registration requires EPA to expedite
the processing of product registrations that are identical or substantially similar to
existing pesticide products and for which no scientific review of data is required.

Under this expedited process, EPA must inform the registrant within 45 days as
to the completeness of the application. EPA then has 90 days to approve or deny
the application for registration. Although EPA has complied with the 45 day limita-
tion, it is rare that the 90-day deadline is met by EPA. As described previously,
ISSA members have pointed out numerous instances where it has taken 6 months
to 18 months to process their fast track registration. This delay creates an anti-
competitive situation, especially for a small company whose only advantage is the
speed with which they can bring a product to market. More importantly, this situa-
tion denies the public the benefit of new and improved products.

In order to address these shortcomings, ISSA suggests that existing resources
within OPP should be used to address tne backlog of fast track registrations. As-
signments of specific personnel to handle fast track registrations should be made.
For instance, one person on a product manager's team should be designated to proc-
ess expedited review registrations. When that person has relieved the backlog, he
or she can be returned to other team assignments. In addition, ISSA encourages
EPA to devote stafT and resources adequate to permit timely and consistent deci-
sionmaking on the relatively large volume of antimicrobial registrations. Resource
allocations should more equitably reflect the amount of fees generated by
antimicrobial products.

Furthermore, under present processing of me-too applications and simple amend-
ments not requiring scientific review, each of these fast track registrations is placed
in one stack with all other applications. ISSA believes that EPA should institute a
two stack approach: one for last track registrations and another for other applica-
tions. This process would help ensure that fast track registrations are not lost in
the crowd and are given the proper attention.

Under present policy, EPA uses a seven step review process for all registrations
including fast track. Such a process is unnecessary for most fast track registrations
because a decision can often be made early on in the process. Consequently, the
seven step process unreasonably adds to the length of time necessary to process a
fast track registration. ISSA encourages EPA to provide a first level reviewer with
the authority to complete the process at the first step thus avoiding undue delay.

ISSA also believes that the color coding of fast track registrations would help en-
sure their expeditious processing of fast track registrations so that they can be more
easily recognized. In the alternative, a pressure sensitive "tab" can be attached to
the application. Either one of these alternatives would allow for the fast track reg-
istration to be more readily distinguishable. At the present, a fast track registration

application is virtually indistinguishable from other registrations increasing the
likelihood of it not being processed in a timely fashion.

Lastly, we believe FIFRA should be amended such that if the Agency fails comply
with the 90 day fast track deadline that such application should be deemed granted.
At the very least, EPA should be required to provide the registrant with an update
and an expected timetable for completion. Such information is essential for reg-
istrants to make calculated business decisions. At the present, no such communica-
tions exist.

To this end, ISSA strongly encourages the subcommittee to adopt section 112 of
H.R. 1627 entitled "Requirements for Registration of Substantially Similar or Iden-
tical Pesticides and Antimicrobial Pesticides and Products." This provision addresses
the shortcomings of the current "fast track" registration system and will instill a
sense of equity in the registration process.

EXPANSION OF NOTIFICATION PROCESS

In order to reduce the present backlog and to free up Agency resources for other
more important tasks, ISSA strongly believes that the notification process should be
broadened in order to expedite common product amendments which do not involve
the introduction or increase in risk. ISSA has recommended to EPA that the Agency
establish a certification process by which a registrant could certify that its registra-
tion application meets tne EPA's requirements for registration. The following are
some examples of the types of registration activities that should be accomplished
through the notification process:

— New areas (i.e., site) or use within the same category not requiring additional
data (i.e., hard surface kitchen; hard surface bathroom).

— EPA initiated label changes (e.g., new container disposal regulations).

— Environmental marketing descriptions subject to FTC restrictions.

— Notification or self-certification of acute toxicology studies, except for inhala-
tion and dermal sensitization.

ISSA strongly believes that the expansion of the notification process is essential
to reduce the existing backlog so that the Agency is able to free up valuable but
limited resources. Just as important, the expansion of the notification process
should also help ensure that any future registration backlogs are avoided.

COORDINATION AND SYNCHRONIZATION OF PESTICIDE DATA REQUIREMENTS
BETWEEN EPA AND THE STATES

ISSA encourages the subcommittee to approve legislative language which would
facilitate the coordination and synchronization of data between the States and the
U.S. Environmental Protection Agency. Such coordination and synchronization is es-
sential to avoid redundant testing ana unnecessary and substantial expenses.

The present problem is exemplified by California's Birth Defects Prevention Act,
S.B. 950. This legislation requires the filling of data gaps for all pesticides including
antimicrobial products. In order to implement S.B. 950, California adopted a defini-
tion of a "data gap," established a list of tests needed to be completed, and set a
time table for filling these gaps. In so doing, the State has disregarded the efforts
of Congress in establishing its own expedited reregistration program in the 1988
amendments to FIFRA which were designed to fill essentially the same data gaps.

In effect, California has established an agenda and time table that duplicates and
conflicts with Federal requirements. Such inconsistent requirements result in un-
necessary, repetitive and redundant testing that not only consumes valuable time
and resources but also delays the closing of data gaps. Valuable time and resources
that could be used to develop new data are wasted in refocusing on gaps that have
already been or are in the process of being filled.

The additional and conflicting data requirements artificially raise the cost of man-
ufacturing and distributing pesticide products. It is important to note that many low
volume, low profit specialty antimicrobial pesticides may be discontinued because
neither the registrant, the formulator, nor the State will pay for the additional tests
required on active ingredients. In fact these additional costs have resulted in the
cancellation of numerous antimicrobial product registrations in California. This pat-
tern is likely to continue as other States enter the picture once again forcing other
necessary and useful products off the market.

Therefore, ISSA strongly encourages the subcommittee to explore legislation that
would facilitate the coordination and synchronization of data requirements between
the States and the EPA. Such legislative action will help stabilize the cost of pes-
ticide products by precluding unnecessary and redundant testing, thereby ensuring

the continued availability of a wide range of antimicrobial products. Specifically we
urge the subcommittee to adopt the language contained in section 113 of H.R. 1627
entitled "Synchronization and Coordination of Data Between Federal and State
Agencies."

PUBLIC HEALTH PESTICffiES

S. 2050 contains a provision, supported by ISSA, which recognizes the need to
protect the continued availability of public health pesticides. Specifically, S. 2050
would direct the Department of Health and Human Services and EPA to collaborate
in identifying critical public health minor uses that might otherwise be lost and to
arrange for necessary data support. In this regard, S. 2050 authorizes appropria-
tions in the amount of $12 million to be used in providing support for the required
studies needed to continue the registration of public health pesticides.

ISSA supports the public health pesticide provisions contained in S. 2050. In sup-
porting these provisions, we suggest that the subcommittee incorporate into FIFRA
amendments the provisions of H.R. 1867 introduced by Representatives Dooley and
Herger, and more formally known as the Public Health Pesticides Protection Act.
This legislation ensures that EPA establish guidelines that take into consideration
the benefits of public health pesticides, and to ensure that these products are not
lost in the rcregistration process due to economic reasons alone.

H.R. 1867 was introduced to provide recognition and relief for pesticides reg-
istered for public health purposes. The legislation would extend special consider-
ation and protection to pesticide products used to maintain good mosquito and other
vector programs. In addition, H.R. 1867 would extend the same treatment to certain
disinfectants, sanitizers, and other antimicrobial products.

ISSA supports H.R. 1867 because it recognizes the importance of these products
in maintaining safe and healthful conditions in society. These products, however,
have experienced tremendous regulatory burdens because they are treated just like
agricultural pesticides in many cases. These burdens have become so substantial
that many products have been dropped from the market because it is no longer eco-
nomically feasible to maintain their EPA registration. Consequently, many products
essential to the maintenance of safe and healthful conditions will continue to be lost
unless some relief is provided.

ISSA believes that H.R. 1867 provides that relief. Specifically, H.R. 1867 would
accomplish the following:

— The bill would define "public health pesticides" in the context of minor use to
include a pesticide which is used in the prevention or mitigation of viruses, bacteria,
or other microorganisms that pose a threat to public health.

— Create a separate class of pesticide registration for public health pes-
ticides with a risk benefit analysis, separate and distinct from that utilized
for agricultural pesticides.

— Expedite the registration of pesticides necessary for public health protec-
tion.

— Require EPA to take into consideration the difierences in concept and
usage between agricultural, nonagricultural, and public health pesticides.

— Require EPA to consult with the Secretary of Health and Human Serv-
ices on pesticides for public health uses.

For these reasons, ISSA seeks the inclusion of H.R. 1867 into any set of FIFRA
amendments the subcommittee ultimately approves.

Conclusion

ISSA commends the subcommittee for conducting these hearing and encourages
it to move forward and markup a FIFRA bill as soon as possible. ISSA objects to
any FIFRA package that would create new pesticide fees or extend existing mainte-
nance fees. Such action is premature and snould only be considered after we have
received an accounting from the Agency.

ISSA supports the provision in S. 2050 that establishes one uniform compliance
date for label changes. However, we encourage the subcommittee to incorporate lan-

Bage that would establish a central office within the Agency to coordinate all such
Del changes. We firmly believe such an ofTice is essential not only to address tim-
ing problems, but also to address inconsistent labeling language requirements.
While we support the uniform labeling compliance date, we oppose those provisions
of S. 2050 that would expand the EPA's authority to suspend and recall products
whose label may deviate even slightly from the Label Call-in provisions of the biU.

100

ISSA also encourages the subcommittee to incorporate provisions that would fa-
cilitate the coordination and synchronization of data requirements between the
State and Federal Governments. Last, ISSA urges the sulKommittee to expand on
the public health pesticide provisions of S. 2050 by incorporating the language of
H.R. 1867.

We thank the Members of the subcommittee for this opportunity to express our
views on this subject of utmost concern to our industry.

Warren E. Stickle

INTRODUCTION

I am Warren E. Stickle, president of the Chemical Producers and Distributors As-
sociation (CPDA). We at CPDA are delighted to have the opportunity to submit our
testimony for the record in response to the July 28, 1994 pesticide hearings con-
ducted by the Senate Subcommittee on Agricultural Research, Conservation, For-
estry and General Legislation of the Committee on Agriculture. In our testimony,
we will discuss the administration's pesticide legislation as well as a number of re-
lated issues of importance to our association.

By way of introduction, CPDA is a voluntary, nonprofit membership association
consisting of about 90 member companies engaged in the manufacture, formulation,
distribution and sale of some $3.5 billion worth of products used on food, feed and
fiber crops, and for lawn, garden and turf care.

Before we share with Members of this subcommittee our thoughts regarding
S. 2050 and S. 2084, we would first like to commend you, Chairman Daschle, for
moving forward with hearings on this legislation. We look to your leadership to
bring together the many divergent views regarding the regulation of pesticides in
reaching a fair and reasonable consensus on FIFRA.

We will first turn to S. 2050, the administration's legislation to amend FIFRA. We
at CPDA have a number of concerns with this legislation and today we will offer
our thoughts on how this legislation could have a severe impact on CPDA mem-
bers— many of whom are small to medium-sized companies. In discussing the many
changes proposed in the administration's bill to amend FEFRA, we will also share
with the subcommittee some alternative proposals developed by CPDA which, we
believe, will accomplish the common goal shared by all — namely, the preservation
of the integrity of our nation's food supply and the increased efficiency and improve-
ment of EPA's pesticide programs. Many of these initiatives have already been in-
corporated into legislation, H.R. 1627, as amended by the House Subcommittee on
Department Operations and Nutrition (DON) during its July 27, 1994 FIFRA mark-
up.

Our other comments will focus on S. 2084, the administration's bill to amend the
Federal Food, Drug and Cosmetic Act (FFDCA). CPDA's testimony will address the
concept of negligible risk in setting tolerances for pesticide residues in foods and we
will examine related food safety issues which include the national uniformity of tol-
erances and inerts. Again, we thank you for the opportunity to submit CPDA's
statement for the hearing record.

PESTICIDE REGULATION UNDER FIFRA
PHASE-OUT/PHASE-DOWN

CPDA is strongly opposed to the provisions contained in S. 2050 which would
allow the EPA Administrator to phase-out or phase-down the use or production of
a pesticide if scientific evidence indicates that its use is "reasonably likely to pose
a significant risk to humans or the environment." In fact, the House Subcommittee
on Department Operations and Nutrition rejected these provisions in its recent
markup of FEFRA legislation.

First, we at CPDA believe that other safeguards in FIFRA exist which allow the
Administrator to address potentially harmful chemicals. For example, current
FEFRA already allows the Administrator the authority to place certain restrictions
on the use of a pesticide as a condition of its registration. Second, we believe that
the improvement of the present cancellation procedures so as to provide a more ex-
pedient method for removing bad actors from the marketplace would obviate the
need for any provisions calling for a phase-out or phase-down of the use and produc-
tion of a chemical for which EPA has concerns pertaining to its safety.

Third, the administration's phase-out/phase-down provisions are based on a com-
paratively lenient standard that a chemical is "reasonably likely" to pose a "signifi-
cant" risk to humans or the environment. We at CPDA do not believe that it is pru-

101

dent to proceed with a regulatory action against a chemical which could have a seri-
ous adverse impact on growers and other end-users simply on the premise that a
product is "reasonably IDtely" to pose a "significant" risk. Rather than a regulatory
standard based on "significant" risk, it should be an "unreasonable" risk. The grave
consequences that would result from eliminating or capping the production of a pes-
ticide necessitates that a higher degree of certainty relating to any risk associated
with use of that pesticide be adopted. The standard contained in the administra-
tion's bill could be abused by those who would advocate a total ban of all pesticides
and lead to a modem day witch hunt targeting hundreds of necessary and beneficial
products which have been in common use for years without resulting in any harm
to man or the environment.

We at CPDA agree with the remarks of Representative Robert F. Smith (R-OR),
ranking minority member of the House Subcommittee on Department Operations
and Nutrition, which appear in the record of that panel's July 27, 1994 FIFRA
markup. Representative Smith states, ". . . In addition to my concern that it would
encourage EPA to circumvent the FIFRA cancellation process, I believe that a gray
area for pesticide registration status, which would be created by the administra-
tion's phaseouty phase down is irresponsible. A chemical is either safe for use or it
isn't. To further confuse the issue by instituting a 'phase-out' does a disservice to
producers, possessors, and consumers. With 'phase-out' the EPA may just want a
tool it can use to manage public opinion disasters, but it wiU come at the expense
of sound public policy."

Fourth, the Clinton phase-out/phase-down proposal erroneously equates the elimi-
nation of pesticide use with a reduction in risk. Science has clearly demonstrated
that such a correlation cannot be made. The curtailment or elimination of a pes-
ticide product from the marketplace could have an adverse impact on a farmer's
ability to exercise Integrated Pest Management (IPM). The success of IPM is de-

fiendant, in part, on a wide range of pest control tools being made available to the
armer. The disappearance of one product from the farmer's arsenal could actually
result in a shift m use patterns to other products which may pose an even greater
potential risk.

Finally, we at CPDA believe that careful consideration must be given to the po-
tential economic impacts which would occur if production caps were to be placed on
Eesticides marketed primarily for export. By far, the regulatory standards of the
United States are much stricter than those of many of our global trading partners.
The higher cost basis for United States producers who must incur significant capital
expenditures to comply with stringent Federal regulatory standards already places
domestic manufacturers at somewhat of an economic disadvantage compared to
their foreign competitors. We at CPDA believe that it would be unwise to adopt leg-
islation calling for caps on American production which could further erode the posi-
tion of domestic pesticide manufacturers in the global markets. Such legislative pro-
visions would place American jobs in serious jeopardy at a time when the United
States is seeking to strengthen its economy. CPDA strongly recommends that this
subcommittee to reject the phase-out/phase-down provisions of S. 2050.

Fees. We at CPDA are adamantly opposed to those provisions of S. 2050 which
would provide EPA with additional pesticide fee authority. The House Subcommit-
tee on Department Operations and Nutrition rejected a similar fee provision in its
deliberations over H.K. 1627. CPDA members believe that it is premature to create
additional fees when the Agency has not yet provided a detailea cost accounting of
how and where the moneys collected in the reregistration program have been spent.

In the last 3 years, the EPA has maintained that its reregistration program is
experiencing a snortfall of revenues. Three years ago, this deficit was estimated at
$160 million, then $100 million, and then ^0, $35 and $32 million. Appearing be-
fore a joint House-Senate Congressional committee hearing on September 22, 1993,
administration officials estimated that the current reregistration shortfall was $20-
million. Now, however, it would appear that the fee provisions in S. 2050 are cal-
culated to generate in excess of $60 million in additional fees. CPDA asks that the
subcommittee take a closer look at the numbers.

First, S. 2050 provides for a 2-year extension of EPA authority to levy mainte-
nance fees through September 30, 1999. We would like to point out to this sub-
committee that back in the fall of 1991, CPDA and four other industry trade groups
negotiated a compromise on maintenance fees with EPA. This compromise was ulti-
mately adopted as part of the technical corrections package amendment to the 1990
Farm bill which was signed into law by President Bush.

The compromise package included provisions which:

• adjust the cap for the first 50 products from $20,000 to $55,000, and increase
the cap for products 51 or more to $95,000;

102

• maintain the fee at $650 for the first product, and $1,300 for each additional
product up to the adjusted caps;

• establish a small business cap at $38,500 for the first 50 products, and $66,500
for products 51 or more. A small business registrant is a corporation, partner-
ship, or unincorporated business that has 150 or fewer empbyees ana during
the last 3-year period had an average annual gross revenue from chemical sales
that did not exceed $40,000,000;

• beginning in 1992 and continuing through 1997, adjust the payment timetable
from March 1 to January 15, thus allowing the Agency to collect fiinds earlier
to mitigate its existing cash-flow problems;

• allocate one-seventh of the maintenance fees collected by EPA in 1992, 1993
and 1994, and in 1995, 1996 and 1997 up to $2 million annually to accelerate
reregistration (Fast Track) and expedited processing of funds.

This amendment package raised $15.1 million thus fulfilling its statutory require-
ments included in tne 1988 FIFRA amendments. In fact, it created a surplus of at
least $1.1 million beyond the $14 million required under FIFRA. As such, a 2-year
extension of maintenance fee authority, as proposed by S. 2050 can be expected to
generate an additional $30.2 million (i.e., $15.1 million>year x 2 years).

Second, S. 2050 calls for a $120,000 supplemental reregistration fee on an active
ingredient registered for a major food or feed use and a $60,000 supplemental rereg-
istration fee lor active ingredients registered for nonagricultural uses. If two or more
registrants are required to pay the supplemental reregistration fee, the fee would
be apportioned among the registrants on the basis of United States sales of the ac-
tive ingredient during 1990-1992. The active ingredient fees set forth in S. 2050
represent levels which stand at about 80 percent of the fees adopted by Congress
in enacting FIFRA "Lite" in 1988. If one considers that in 1989, EPA collected some
$35 million in active ingredient fees as a result of the fee levels established by
FEFRA Lite, we can expect to collect some $28.0 million, or 80 percent of the 1989
levels, under the adjusted active ingredient fees proposed under S. 2050.

Third, the administration's legislation calls for a $750 per product reregistration
fee which would apply to all products deemed eligible for reregistration. Under
S. 2050, the Administrator of EPA would be given the authority to adjust this fee
to a level that would generate at least $4,000,000 during the 4-year period following
enactment of the legislation.

Below is a summary of the total revenues that can be expected if the three fee
authorities detailed in section 11 of S. 2050 were to be adopted:

[In millions of dollars]

• A 2-year extension on maintenance fees: $15.1 million/year x 2 years 30.2

• A $750 reregistration fee per product 4.0

• AI: $120,000 (food uses); AI: $60,000 (nonfood uses); (80 percent of $35
million collected in 1989!) 28.0

Total: 62.2

The $62.2 million as calculated above, far exceeds the $20 million shortfall stated
by EPA officials in testimony presented to Congress last September.

The lack of consistency in EPA's funding estimates illustrates the strong need for
a full and complete explanation of expenditures for the registration and reregistra-
tion programs, including Fast Track expenditures. We at CPDA believe that Con-
gress should require EPA to provide a clear and detailed accounting of where and
how the moneys have been spent since the reregistration program was created
under the 1988 FIFRA amendments. It is only when we obtain a full accounting of
the program that we can then come up with an accurate cost of the reregistration
program and a definite assessment of tne shortfall.

In testimony presented before the House Subcommittee on Department Oper-
ations and Nutrition last year, Ralph Engel, President of the Chemical Specialties
Manufacturers Association (CSMA), recommended that a provision be written into
FEFRA which would require EPA to contract with appropriate outside management
personnel to conduct a thorough examination of the registration and reregistration
process and to make recommendations in a report to Congress as to how to specifi-
cally improve program performance and meet the 1997 statutory deadline. CPDA
agrees with CSMA and would support the initiation of an outside, independent re-
view of OPP prior to any determination regarding a new request for additional fees.

Like all other Federal agencies, EPA is attempting to "reinvent" government by
seeking ways to streamline its operations to do more with less resources, thus creat-
ing a more efTective and eflicient process. As described more fully elsewhere in this

103

testimony, CPDA has been working with EPA in developing several specific propos-
als which, we believe, will streamline OFF activities by improving certain effi-
ciencies and eliminating the unnecessary waste of limited Agency resources, both fi-
nancial and manpower. We at CFDA are pleased to report that the Agency has re-
sponded in a very positive manner to many of our recommendations and has ex-
pressed a willingness to implement some of our suggestions. Moreover, EFA officials
have indicated that some of these changes could be put in place in as short a time-
frame as four to 6 months. Among the CPDA recommendations which EFA is now
considering include the feasibility of allowing simple registration amendments to be
made through notification and improvements in the process for review of acute tox-
icity data. The changes now under consideration would reduce the employee to man-
ager ratio from its current level of 6 to 1 down to 11 to 1. We at CPDA believe that
the results of this streamlining process should be evaluated before determining the
necessity for any additional EPA resources.

CFDA does not believe that an extension of maintenance fees to 1999 should be
considered until we move closer to these dates and have had the opportunity to see
what impact the various streamlining reforms have had on OPP activities. It is pre-
mature to address the continuation of maintenance fees at this time. There will be
additional FIFRA reauthorizations prior to 1998 at which time this issue can be re-
visited if Congress deems it necessary. Moreover, although the EFA seeks an exten-
sion of maintenance fees for 1998 and 1999, it does not seek an extension of the
prohibition of registration fees for the same timeframe. Thus, under the present
EPA proposal, registrants would have to pay both extended maintenance fees and
new registration lees.

CPDA remains committed to fulfilling its current statutory obligation of raising
$14-million-a-year to fund the reregistration program through September 30, 1997
as provided by FIFRA. However, we strongly believe it is premature to enhance
EPA's fee authority until we have had a full review of how and where EPA has allo-
cated industry fees already collected, and until we assess the impact of the Agency's
present OPP streamlining initiatives.

Rather than the creation of additional fees, the immediate focus of FIFRA should
be on streamlining the reregistration program, improving efficiencies, and eliminat-
ing waste and duplication.

CITIZEN SUITS

CPDA opposes the provisions in S. 2050 which would allow a private individual
to file civil suit against EPA for failure to enforce the requirements of FEFRA. We
at CPDA believe that a citizen suit provision in FIFRA could lead to a proliferation
of frivolous lawsuits brought by every activist group seeking the total elimination
of pesticides. A provision allowing for citizen suits under FIFRA would keep EPA
firmly ensconced in court proceedings and would consume a significant share of
Agency resources which would go toward legal and court fees. CPDA does not be-
lieve that this is an appropriate use of limited Agency funds and manpower. It
would appear that a majority of the House Subcommittee on Department Oper-
ations and Nutrition share this sentiment as evident in the panel's rejection of the
administration's citizen suit provisions during its July 27, 1994 markup of FIFRA
legislation.

REGISTRATION SUNSET

CPDA is opposed to the registration sunset provision contained in S. 2050. This
provision would require that active ingredients be reviewed periodically to ensure
that they are in conformity with scientific standards. If EPA determines that the
pesticide does not meet all applicable requirements, the Agency would be required
to initiate cancellation proceedings. We at CPDA believe that this provision would
create an unnecessary burden for the Agency and the industry alike. We agree that
it is important to address any questions pertaining to the safety and efficacy of reg-
istered chemicals as these questions arise. However, we do not believe that it makes
sense to engage in a wholesale review of every registered chemical. Much of the in-
formation we have on chemicals and the scientific testing methodologies will not
change within the relatively short timeframes set forth in the administration's pro-

Sosal. If EPA has a specific concern pertaining to a chemical, the Agency already
as the authority under the data call-in provisions of F'IFRA section 3(c)(2)(B) to re-
quest the appropriate testing. It is a waste of limited resources to require the resub-
mission of scientific data which will provide little if any additional new information.
CPDA opposes the registration sunset provisions as presently drafted in S. 2050.
We do not oelieve that it makes sense to engage in the wholesale review of every
currently registered chemical. The provisions in the administration's bill would
place the enormous burden on registrants to submit potentially vast amounts of
data to the Agency, much of which might have, at best, marginal value. While fu-

104

ture technology promises to provide the tools to generate ever increasing amounts
of information, some of this "new" data may not represent a significant change from
what we already know about a chemical today.

CPDA recognizes that as science evolves and technology allows for testing at high-
er levels of sensitivity, so will certain data recruirements to support pesticide reg-
istrations change over time. To this end, some of the information necessary to main-
tain pesticide registrations should be updated periodically. However, it is unneces-
sary to duplicate data which is scientifically valid. Once a pesticide has passed the
rigorous requirements of the present reregistration program and the Agency has ob-
tained a complete set of scientifically valid data on a particular product, it is unnec-
essary to generate a repeat battery of tests to obtain information which has already
been accepted and approved by EPA. Instead, further data requirements should
focus on specific and significant toxicological concerns over a pesticide should they
arise in the future. As such, EPA and industry resources can be more effectively
utilized by focusing on specific concerns based on significant evidence of a chemical s
possible unreasonable adverse effect on man or the environment.

When the House Subcommittee on Department Operations, Research and Foreign
Agriculture conducted a markup of FIFRA legislation (H.R. 3742) during the 102d
Congress, it considered a similar provision wnich would have called upon EPA to
perform a "periodic update" of information to support pesticide registrations. At the
time, CPDA endorsed a substitute proposal which would have required EPA to re-
view pesticide registrations and to utilize its existing data call-in authority under
FIFRA section 3(cX2)(B) to obtain information deemed necessary for continued sup-

F)ort of pesticide registration. The proposal also gave EPA a second option of pub-
ishing an order in the FEDERAL Regi^ER which would have identified specific data
requirements and would have described the significant evidence of unreasonable ad-
verse effects to human health or the environment upon which EPA was basing its
request for data. We understand that the intent of the administration's registration
renewal or "sunset" provision is to avoid the type of logpam that has occurred with
today's reregistration program. CPDA believes that this can be achieved through
such an alternative mechanism, as described above, which safeguards against the
unnecessary duplication of data.

CANCELLATION

We at CPDA applaud the administration for including a discussion of benefits in
its recommendations to revise current cancellation procedures under FIFRA. Specifi-
cally, S. 2050 contains a requirement that EPA consider the potential impact of the
proposed cancellation action on consumers, retail food prices, production of agricul-
tural commodities, and the agricultural economy. Dr. John D. Graham, Director of
Harvard University's Center lor Risk Analysis, discussed the importance of benefits
during his testimony presented before the House Subcommittee on Department Op-
erations and Nutrition on July 14, 1993. "If farmers are suddenly unable to use pes-
ticides," he stated, "their crop yields (per acre) may decline due to insufficient pest
control. Since the costs of producing the same level of output would then be higner,
farmers would be forced to charge higher prices for the crops they produce."

"The benefits of lower food prices are not simply financial," said Graham. "[T]hey
impact the health of parents and their children. For example, if higher prices for
fruits and vegetables cause dietary habits to shift away from these foods, an in-
crease in the risk of cancer, heart disease, and other diet-related diseases can be
expected. This outcome is more likely among low-income populations, where price
sensitivity is highest and knowledge of the health efTects of poor nutrition may be
lower."

Dr. Graham further testified that "... In some situations, the loss of a pesticide
may cause direct harm to public health as a result of consumer exposure to the
fungi that thrive without the pesticide. For example, although many fungicides have
been shown to cause cancer in animals at high doses, some of the toxins produced
by fungi, such as afiatoxin, are also known to cause cancer. One of the benefits of
pesticides is the human health protection resulting from the destruction of fungi."
CPDA shares the sentiments conveyed by Dr. Graham. We believe that any changes
to the current cancellation procedures must take into consideration the health and
nutritional benefits to be derived from the use of pesticides. We are pleased that
the administration has seen fit to include this important provision requiring EPA
to consider the benefits of pesticide use before proceeding with a proposed cancella-
tion.

We at CPDA are also pleased that the administration has included in its bill a
process whereby EPA would be required to consult with the Secretary of Agriculture
before proposing the cancellation of an agricultural use pesticide, and the Secretary
of Health & Human Services before initiating cancellation proceedings on a pesticide

105

registered for public health uses. CPDA also supports the directive contained in
S. 2050 which would require EPA to consider changing the classification of a pes-
ticide from general to restricted use as an alternative to cancellation.

Without question, CPDA agrees with the administration that the current cancella-
tion procedures should be streamlined and simplified so as to allow the Agency to
move quickly to remove "bad actors" from the marketplace. The experience of the
last 15 years has clearly demonstrated that the cancellation process has taken too
long, with some products taking more than a decade to remove from the market-
place. However, we feel that in revising the cancellation provisions of FIFRA, cau-
tion must be ttdcen to fully protect the due process rights of the registrant and end
users who depend on the availability of the cnemical in question.

the administration's legislation, S. 2050, would replace the current formal adju-
dicatory hearing process with a notice-and-comment cancellation process which in-
cludes an informal hearing. A registrant would have to request an informal hearing
within 21 days of publication of a proposed cancellation order in the FEDERAL Reg-
ister. Comments on the proposed action would have to be submitted to the Agency
within 90 days of pubhcation in the FEDERAL Register. In the absence of a proce-
dure which would provide for an advance notice ofproposed rulemaking to be issued
prior to a notice of proposed rulemaking, we at CPDA believe that the short time
periods set forth in the administration's legislation are inadequate. Under S. 2050,
registrants, end-users and other interested parties would have only one opportunity
to examine the complex issues inherent in any cancellation action. As such, we
would like to suggest longer time periods during which interested parties could re-
quest an informal hearing and/or submit comments regarding a proposed cancella-
tion.

Moreover, S. 2050 would allow the EPA Administrator to deny a registrant's re-
quest for an informal hearing if "holding a hearing would not be in the public inter-
est." CPDA is concerned that the inclusion of such language could deny a registrant
of his due process rights to hear arguments on all sides as they relate to tne pro-
posed cancellation of a pesticide. It is imperative that any revisions to the cancella-
tion procedures under FIFRA preserve a mechanism which protects the right of a
registrant to defend his product and to present supporting scientific evidence.

While we support the administration s goal of expediting and simplifying current
cancellation procedures, we believe that the cancellation provisions of S. 1478, the
"Food Quality Protection Act of 1993," introduced by Senators Pryor and Lugar, pro-
vide a better alternative for achieving this same objective. In fact, in amending H.R.
1627 during its recent FIFRA markup, the House Subcommittee on Department Op-
erations and Nutrition adopted many provisions which resemble those found in S.
1478.

Like the administration's proposal, S. 1478 would eliminate the current formal ad-
judicatory hearing requirement for cancellation of pesticide registrations. It would
also provide for consultation between EPA, USDA and HHS.

However, unlike the administration's bill, S. 1478 provides for scientific committee
peer review of the evidence supporting proposed cancellation, precancellation notice
to pesticide registrants that includes a summary of the validated test or other sig-
nificant evidence upon which the Administrator proposes its action, an advance no-
tice of proposed rulemaking (to be followed by a notice of proposed rulemaking), and
the rignt to seek judicial review of a final cancellation order. CPDA strongly sup-
ports all of these provisions contained in S. 1478.

In addition, CPDA believes that it is critically important that registrants be given
an opportunity to cross-examine witnesses in any informal hearing adopted as part
of the cancellation process so as to build a complete hearing record. As amended
by the House Subcommittee on Department Operations and Nutrition on July 27,
1994, H.R. 1627 contains such a provision allowing for cross-examination of wit-
nesses. We at CPDA believe that similar language, if incorporated into the cancella-
tion provisions of S. 1478, would provide appropriate protection of a registrant's due
process rights.

SUSPENSION

CPDA is opposed to the suspension provisions contained in S. 2050. the adminis-
tration's bill seeks to decouple suspension from cancellation procedures. S. 2050
would allow a suspension order to remain in effect for a period of 180 days during
which time the EPA Administrator could proceed with initiation of cancellation pro-
ceedings. The suspension order would automatically terminate at the end of 180
days ii the Administrator does not move forward with a proposed cancellation ac-
tion. CPDA does not believe that the current suspension provisions of FIFRA need
to be revised at this time. Suspension, even if temporary, or for a short time, with-
out an opportunity for a public hearing or a fact-based decisionmaking process.

106

would effectively destroy the product and its public credibility. In the absence of the
initiation of a proposed cancellation action, the 180 day suspension period set forth
in S. 2050 is tantamount to placing a chemical in limbo. This provision would mere-
ly serve to unnecessarily undermine public confidence in the safety of America's food
supply and it would generate misgivings concerning the integrity of EPA's regu-
latory framework.

CPDA does not believe that EPA's cancellation and suspension authorities should
be de-linked. As CPDA stated in testimony delivered before the House Subcommit-
tee on Department Operations and Nutrition on March 19, 1992, "An 'easier' sus-
pension authority would subvert the cancellation process by encouraging EPA to use
the 'path of least resistance.'" Suspension authority is an emergency procedure, es-
tablished under FIFRA, which allows EPA to suspend a product deemed to pose an
"imminent hazard" during cancellation proceedings. Current law requires tnat the
Agency issue a proposed cancellation notice before or at the same time it issues a
suspension order. This process ensures that suspension actions will not be taken too
hastily before the full body of scientific evidence is completely evaluated.

The Clinton proposal to decouple the two authorities could result in the potential
misuse of EPA's suspension authority and undermine the science-based cancellation
process. We believe that FIFRA reform efforts should focus instead on streamlining
the sometimes long and protracted cancellation process, thus ensuring that prob-
lem chemicals are removed from the marketplace in an expeditious manner.
CPDA believes that the cancellation provisions of S. 1478 can accomplish this objec-
tive.

LABEL CALL-IN AND LABEL CHANGES

While CPDA supports efforts to streamline EPA mandated label revisions, we
have serious concerns pertaining to the Label Call-in provisions of the administra-
tion's bill. Specifically, we strongly oppose the creation of new suspension and recall
authorities which would allow the EPA Administrator to take action against any
pesticide distributed or sold in violation of the requirements promulgated pursuant
to the label call-in provisions of the bill.

Under current FIFRA, only those pesticides that are suspended and canceled can
be made subiect to a mandatory EPA recall. The language in S. 2050, however,
would expand the scope of products which could be subject to a mandatory recall
to virtually any pesticide with a label violation — no matter how minor the trans-
gression. A product which bears incorrect labeling through perhaps an unintentional
oversight on the part of the registrant certainly cannot be made subject to the same
penalties as that which apply to a product suspended and canceled because of
health or safety concerns. As such, we strongly urge Members of the subcommittee
to reject any legislative language providing for mandatory recall of products under
any legislation which seeks to revise EPA labeling procedures.

Similarly, CPDA believes that the label call-in provisions of the administration's
bill would significantly relax the circumstances under which the EPA could initiate
suspension proceedings. Present FIFRA allows the Agency to issue a suspension no-
tice only if EPA deems that a product poses an "imminent hazard." Again, the ad-
ministration's legislation makes it mucn easier for the EPA to suspend a product
by removing the criteria that a product poses an "imminent hazara." As with the
recall authority contained in S. 2050, the new suspension powers could be used
against a number of products for relatively minor, inadvertent label violations.
CPDA opposes any efforts to weaken the criteria under which EPA is allowed to pro-
ceed with a suspension action.

As mentioned earlier in our testimony, CPDA supports the administration's goal
of streamlining label changes and establishing uniform label compliance dates. In
particular, CPDA applauds the administration for proposing that one annual date —
October 1st — ^be designated as the date by which registrants must comply with sim-
ple mandated label changes aimed at reducing the potential risk associated with the
use of a pesticide.

We at CPDA would like to see this proposal broadened to also stipulate that one
ofTice within EPA be established to coordinate all mandated label changes for pes-
ticide products. During its markup of FIFRA legislation (H.R. 1627) on July 27,
1994, the House Subcommittee on Department Operations and Nutrition adopted
legislative language which establishes a labeling program within the Office of Pes-
ticide Programs (OPP). Section 119 of the subcommittee passed bill requires that
all specific label changes mandated by the EPA Administrator be coordinated
through this program. The measure requires the EPA Administrator to publish, on
October 1st of each year, a list of all label changes mandated for the following year.
All afi'ected pesticidfe products initially released for shipment two or more years
after the final announcement would contain the revised laoel language. We at CPDA

107

strongly support the label reform language adopted by the House Subcommittee on
Department Operations and Nutrition in its markup of FIFRA legislation, H.R.
1627. We urge Members of this Senate subcommittee to include the House provi-
sions on labeling reform when it comes time to vote on a set of amendments to
FIFRA.

Many different offices and programs within EPA's OfTice of Pesticide Programs
(OPP) require, at different times, changes on a pesticide oroduct's label. Some of
these EPA mandated changes might be to change an ingreaient, an inert, or a use.
Sometimes a label might need to reflect some new set of directions or warnings
about use or specific health and safety instructions. Sometimes the Agency may re-
quire that the registrant reshape the label or reduce its size, or place new instruc-
tions for proper disposal of the container on the label.

Specific programs also address specific needs to change the label, such as the En-
dangered Species Program, container rinsing proposals from the new FIFRA "Lite"
requirements, and other programs. In addition, label changes may be requested
from the Air and Water Divisions of EPA to conlorm with the Clean Air and Water
Acts. Many different offices and programs require the registrant to make changes
on the label, but no one part of the Agency coordinates appropriate label changes.
These various programs do not know what the other parts of the Agency are doing
about label changes.

A company frequently makes a label change in response to an EPA office's re-
quest, and prints thousands of new labels, only to find that another EPA office, pro-
fram or division is requiring additional changes. Many companies print up new la-
els just in time to throw them in the trash. It can be an expensive, time-consuming
and frustrating experience and means money and jobs for many small businesses
who are fighting to compete in a tough market.

To give you some idea of the magnitude of this problem, a random sampling of
CPDA companies indicates that, on average, they spent in excess of $808,600 oyer
the past 6 years on labels which were ultimately discarded. For these companies,
this translates to approximately 5,600 wasted man-hours and represented more
than 1,613,000 labels which never saw the light of day. When one extrapolates these
figures to the entire industry, it becomes very apparent that a problem exists which
needs to be addressed quickly.

A number of CPDA member companies cite a definite lack of coordination between
product managers. Label Improvement Program (LIP) personnel, and other Agency
staff in formulating label requirements. Representatives of one CPDA member com-
pany, for example, report that they have oeen required to write the Confidential
Statement of Formula (CSF) for the same pesticide in different ways for different
EPA personnel. This same company also notes that it has received conflicting in-
structions from various Agency personnel regarding the wording of the Precaution-
ary Statements found on pnenoxy labeling.

Other OPP programs which afTect reregistration, the container disposal program,
the regulation of inerts, farm worker protection standards, certification and training
requirements, and product reclassification will certainly have an impact on the fate
of present labels or the re-labeling of existing stocks.

One small-sized formulator of lawn and garden products responds that it seeks
to reduce waste in its labeling operations by printing small quantities of labels on
a more frequent basis. However, the company also notes that it is then faced with
the disadvantage of having to pay a significantly higher unit cost per label. In these
troubled economic times, a small business cannot afford to incur such needless and
unnecessary costs.

In an effort to improve the way in which the Agency handles label revisions, we
at CPDA suggest that one office in OPP, within the Registration Department,
should coordinate all label changes from all programs, all product managers, and
all divisions so that there is no confusion about the necessary changes needed to
comply with EPA's mandates. At present, many difTerent offices and programs re-
quire the registrant to make changes on the label, but no one part of the Agency
coordinates appropriate label changes.

Second, one date each year should be selected for all EPA-mandated label
changes. We support October 1st, the date set forth in S. 2050, as a good date be-
cause it represents the end of the growing season as well as the beginning of a new
fiscal year. All label changes could be effective on this date, so that companies can
start production in the fourth quarter for the following Spring's use. We would like
to point out that this date is also found in the labeling reform provisions of H.R.
1627, as amended by the House Subcommittee on Department Operations and Nu-
trition.

Third, companies need enough lead time to implement the Agency's requirements
for both new product labeling and for the re-labeling of existing stocks. We support

108

the timeframes set forth in H.R. 1627, as amended in subcommittee, whereby all
affected pesticide products initially released for shipment two or more years after
the final announcement would be required to bear the revised label language.

The Agency ha^ already taken steps to improve its labeling process by assembling
a team of six staffers to work on label improvement. CPDA would like to recommend
that this process be taken one step further and that Congress adopt legislation to
establish a formal oflice to handle labeling streamlining so that EPA receives the
appropriate funding and resources to effectively implement a label improvement
program.

REDUCED RISK PESTICIDES

We at CPDA support efforts to promote the safe use of pesticides. However, we
have several concerns pertaining to the administration's legislation which would es-
tablish a 180-day priority review of pesticide registrations deemed "reduced risk."
Specifically, we believe that EPA's already limited resources would be severely
strained under the registration priority schedule set forth in S. 2050. The registra-
tion of many effective and beneficial products would be delayed if EPA resources
were to be focused primarily on chemicals meeting the criteria of "reduced risk." The
registration of specialized, niche-oriented minor use pesticides could suffer the most.
The economics of developing low volume minor uses is already cost prohibitive due
to expensive testing requirements. It takes about $50 million and five to 10 years
to bring a pesticide proauct onto the market. Delays in the registration of minor use
pesticides in deference to so-called "reduced risk" chemicals would further erode the
profitability of many minor uses and take away any incentive to develop these
chemicals.

Moreover, we at CPDA believe that the designation of a new product as a "re-
duced risk" pesticide could misguide the public's perception of older chemicals, many
of which have been used for years without significant harm to man or the environ-
ment. EPA's role is to ensure that all pesticide registrations meet the same stand-
ard under current FIFRA of posing no unreasonable adverse effects to human health
or the environment. If EPA is allowed to make a public judgment that one chemical
is safer than another, the Agency would indirectly play a role in influencing market-
place trends. We at CPDA do not believe that EPA should be involved in shaping
the market by favoring one product over another.

Many older pesticides should qualify for designation as reduced risk pesticides.
Some products are being developed that significantly reduce the use of active ingre-
dient, with reduction oi 25 to 50 percent. Some products shift to new delivery sys-
tems, while others change their packaging to reduce exposure. Products in water
soluble bags reduce exposure to handlers and applicators. Each of these types of
"old" chemicals actually reduces risk and should be considered "reduced risk pes-
ticides."

In addition, the elimination of older pesticides from the marketplace could have
a negative impact on Integrated Pest Management as farmers are left with fewer
tools to combat pests effectively. A broad, diverse product line which includes the
continued availability of older chemicals must be preserved so that farmers may en-
gage in IPM practices as a means of preventing the buildup of resistance to pes-
ticides.

EXPORTS

We at CPDA do not believe that the laws governing the export of pesticides needs
to be changed at this time. Indeed, at a time when the United States is seeking
to promote its trading status in the global markets, the implementation of unneces-
sary export restrictions could have a negative impact on American jobs.

While we support the administration's goals of ensuring that chemicals banned
for health or safety reasons do not make their way onto foods imported into the
United States from foreign countries, CPDA believes that the Agency has already
embarked on a number of initiatives aimed at improving the regulation of pesticide
exports. For example, the EPA is working with OECD member countries on several
pilot projects aimed at achieving uniformity in international pesticide regulation. In
addition, on January 1, 1992, the Food and Agricultural Organization (FAO) and
United Nations Environment Programme (UNEP) jointly implemented the inter-
national program on Prior Informed Consent (PIC). The PIC program embraces
many of the concepts set forth in the export provisions of S. 2050 by allowing par-
ticipating nations to receive information about pesticide exports that have been
banned domestically for health or safety reasons. Participating nations would have
the opportunity to prohibit these chemicals from moving across their borders.

In other activities, the United States has negotiated a set of sanitary and
phytosanitary standards under NAFTA and the Uruguay Round trade discussion

109

aimed at protecting the integrity of foodstuffs entering our country. The focus of
these talks has been to harmonize standards, faciUtate compliance, and eliminate
any unnecessary nontariff barriers to trade.

In the last 3 years, considerable progress has been made concerning the increased
regulation of pesticide exports. We at CPDA oppose the inclusion of section 3 of
S. 2050, and recruest that it be deleted.

Section 3(b)(4) states that "no person may export a pesticide to a foreign country
if any ingredient of the pesticide has not been and is not the subject of any registra-
tions under section 3 . . ." We interpret this language to mean that unregistered
pesticides can be exported as long as the active ingredient and/or end use product
has been registered by another entity. For example, company A registers product
Y and sells it in the United States and abroad. Formulator B buys product i from
company A, but only exports the product (not for use in the United States). Con-
sequently, unregistered products should not be labeled as unsafe pesticides.

There are numerous reasons why a product may not be registered with EPA.
These include, but are not limited to:

• The producer does not want to subject himself to current FIFRA data compensa-
tion liabilities. With the threat of millions of dollars in data compensation pay-
ments, many would-be competitors back away from the U.S. market.

• The producer is concerned with the current wave of product liability litigation
in the United States and does not want to fall victim to potential lawsuit.

• The producer does not feel the costs involved in generating EPA data can be
justified by potential United States sales.

• Many foreign pesticide manufacturers have made arrangements with large
multi-national firms to compete in the U.S. market. Thus, they will not allow
their products to be registered in the United States and will only sell manufac-
turer goods which are to be formulated and exported.

• Different analytical methods used by countries in measuring active ingredients.

• Crops are not grown in the United States or the particular pests do not exist
domestically.

Thus, this legislation could have great impact on many companies. For example,
one of our companies sells natural pyrethrins in the United States and Canada, via
an EPA registered pesticide, according to an EPA accepted AOAC method of analy-
sis. These products can be sold in the United States and Canada because they con-
form to standards accepted in these countries, but cannot be sold anywhere else in
the world with an EPA registration, its EPA label or its AOAC method of analysis.
The exact same product, with the identical six esters, is not analytically measured
by the same standard. The rest of the world abides by the analytical method devel-
oped and approved by the Pyrethrin Board of Kenya (PBK). The internationally ac-
cepted PBK creates a differential of 10 percent in favor of PBK. For example, a 100
percent concentration in the United States might be 10 ounces, but the identical
concentrate in Kenya would be recorded as 11 ounces. A standard 20 percent pjT^-
thrin extract measures 22.11 percent in Kenya, despite the fact that they are an
identical product.

For 60 years, a conflict over analytical measurement has existed between the
United States and Kenya, and for almost 35 years, this company has exported a py-
rethrin product, identical to its United States counterpart, to the rest of the world
with a label approved and accepted by PBK and the world.

Because of the differences in analytical methods, these products are NOT reg-
istered in the United States or Canada. Provisions of S. 2050, requiring the export
of only EPA registered pesticides, would prevent the sale of these products overseas.
If the company could not export these products, we feel confident that other compa-
nies in the United Kingdom, France, West Germany and Australia would imme-
diately step forward to fill the void, further reducing American export opportunities.

To register this identical pyrethrin product in the U.S., according to EPA's accept-
ed AOAC analytical methods, the concentrations would have to be labeled 22.11 per-
cent concentrate (not 20 percent). Since there would be a perceived "difference ' in
concentration, the EPA would probably treat this product as a "new" product, re-
quiring a complete set of data based on the testing of this concentrate. It would not
be a "me-too" registration. Consequently, it could take between two and 3 years or
more to register this "new" product, during which time period the product could not
be sold on the international market. The cost of this registration effort, with product
chemistry testing, and other testing, could run between $75,000 to $100,000.

Although S. 2050 supposedly is designed for agricultural uses {i.e., food, feed or
fiber crops), it groups all pesticides together, including nonagricultural products
such as sanitizers, disinfectants, cleaners, etc. Any pesticide export section, by defi-

110

nition, should be restricted to agricultural food uses such as those products used on
food, feed or fiber crops.

We at CPDA strongly oppose the establishment of "fees on pesticide registrants"
for the purpose of covering the costs of this EPA program.

First, at a time when, as a Nation, we are attempting to create more jobs here
at home, while stimulating exports abroad, it is ludicrous to tax our own exports,
thereby driving up their costs and making them less desirable.

Second, the legislation gives the Agency the power "to assess fees on pesticide reg-
istrants." Thus, it broadly applies to all registrants, including those tnat don't ex-
port. Why should a small American formulator who does not export be forced to sub-
sidize the exports of a larger, international company that is exporting? It is unfair
to subject any company that does not export pesticides to the same fees that apply
to those companies that do export.

Finally, we do not support the creation of a $4-million technical assistance pro-
gram. Ii the Agency is looking for a home for $4 million, it can "reinvest" it in the
registration or reregistration program.

THE administration's AMENDMENTS TO THE FEDERAL
FOOD, DRUG AND COSMETIC ACT

We at CPDA would now like to address S. 2084, the Pesticide Reform Act of 1994,
introduced by Senator Edward M. Kennedy (D-MA) as part of the Clinton adminis-
tration's key proposals to amend the Federal Food, Drug and Cosmetic Act
(FFDCA). This legislation raises many concerns by: (1) creating unnecessary and du-
plicative EPA regulations; (2) stimulating significant additional costs; (3) increasing
the burden on Agency resources; (4) creating a "new" Delaney clause; (5) delaying
the reregistration process by superimposing a new tolerance review process;
(6) encouraging the worst case assumptions on exposure data and pesticide residues
on food; and, (7) containing no uniform national tolerances.

THE DELANEY CLAUSE AND THE NFPA PETITION

Over the past several years EPA has publicly stated that without legislative inter-
vention, it is bound to implement the court decree from Les v. Reilly, which inter-
prets the Delaney clause under a zero risk standard. Under current EPA policy, this
could require EPA to revoke large numbers of food tolerances subject to the Delaney
clause and could result in a disturbance of the Nation's food supply. In regards to
the court mandate, EPA has stated that the Ninth Circuit Decision "does not reflect
good public policy or good science policy" and that the pesticides subject to Delaney
pose only a negligible risk to public health."

Yet EPA has failed to implement administrative changes which would mitigate
the adverse effect of Delaney on agriculture and the Nation's food supply. Despite
2 years of deliberation, the Agency nas failed to respond to the National Food Proc-
essors Association (NFPA) administrative petition to decouple 408 tolerances from
409 tolerances. Because the Delaney clause only applies to 409 tolerances, a decou-
pling of 409 and 408 tolerances would leave many safe and beneficial pesticide raw
food uses and registrations undisturbed. However, under current Agency policy a
408 tolerance and its registration may be revoked if the 409 tolerance is revoked
and the pesticide concentrates in processed food.

The decoupling of 408 and 409 tolerances represents the exercise of sound sci-
entific and legal practice by EPA and could be accomplished administratively with-
out legislative intervention.

Instead, EPA has declined to release a public statement on the NFPA petition and
continues to revoke, in a piecemeal fashion, 409 tolerances. In all likelihood, the re-
luctance of EPA to fix Delaney from a regulatory perspective, stems from its desire
to gain political pressure for passing its legislative agenda.

Although CPDA believes the Delaney clause's "zero-risk standard is no longer sci-
entifically justified and is virtually impossible to achieve, we do not believe the ad-
ministration's proposed health based tolerance standards, which ignore a benefits
evaluation, will satisfactorily solve the Delaney problem. The FFDCA can be amend-
ed in a simple manner to reinstate the flexible concept of "negligible risk" (a concept
which EPA has long supported) when setting permissible tolerances for pesticides
in processed food. A strict health based standard, as proposed by the Administra-
tion, will likely cause the revocation of tolerances which do not pose a real health
threat to the American public and will likely cause a disruption of the Nation's food
supply.

Ill

We at CPDA strongly support S. 1478, the Food Quality Protection Act of 1993.
The bill would create a single negligible risk standard for tolerances for pesticide
residues in raw commodities and processed food. EPA would be responsible for de-
fining negligible risk in light of evolving science, taking into account different routes
of exposure to a pesticide and sensitivities of population subgroups. EPA would be
required, where reliable data are available, to calculate the dietary risk posed to
food consumers by a pesticide on the basis of the percent of food actually treated
with the pesticide ana the actual residue levels of the pesticide that occur in food.

These provisions of S. 1478 resemble the tolerance setting provisions of H.R. 1627,
as it was amended by the House Subcommittee on Department Operations and Nu-
trition during its recent markup of pesticide legislation.

BACKGROUND ON THE DELANEY CLAUSE

The U.S. Court of Appeals for the Ninth Circuit ruled in Les v. Reilly on July 8,
1993 that section 409 of the Federal Food, Drug, and Cosmetic Act, the 'TDelaney
clause," requires EPA to apply a "zero-risk" standard for carcinogens when setting
permissible tolerances for pesticides in processed food.

The Les ruling could have a disastrous effect on the abundance and safety of our
nation's food supply and the agrichemical industry as a whole. The decision could
lead to the cancellation of thirty five different pesticides, which comprise more than
10 percent of the basic pesticide ingredients used in agriculture, and hundreds of
different uses which were previously approved by EPA.

In 1958 Congress passed the Delaney clause, which states in part that "no addi-
tive shall be deemed to be safe if it is found to induce cancer when ingested by man
or animal." EPA had previously construed this clause using a de minimis standard
for pesticide residues in processed food.

Under the de minimis standard a tolerance was granted if the human dietary risk
from a pesticide was so remote that the threat ofcontracting cancer was "at most
negligible." The Ninth Circuit, however, has interpreted the Delaney language
"found to induce cancer" to mean no traces of carcinogens in residues for processed
food, regardless of how borderline the response in test animals or how marginal the
risk may be to consumers.

The zero risk" standard is simply unworkable for establishing reasonable risk
evaluation. When Delaney was promulgated, almost thirty 5 years ago, the usual
scientific testing standards measured in the parts per million. Scientific detection
standards now measure in the parts per trillion and greater, resulting in the detec-
tion of carcinogens which present at the most a remote and negligible threat to the
public.

A mass revocation of these pesticides will likely lead to fruit, grain, and vegetable
price increases and a decline in the quality of our food. A subsequent reduction in
the consumption of these products by our citizens could lead to the erosion of our
health and the nutritional integrity of our diets. The American Cancer Society
strongly maintains that Americans need to double their present consumption of
fruits, vegetables, and fiber to reduce the incidence of various types of cancers. Im-
plementation of a "zero-risk" Delaney clause would therefore likely increase the inci-
dence of cancer across the country.

The EPA has a vast wealth of resources, personnel, and scientific knowledge it
uses to draft pesticide policy. As a Federal agency it has the regulatory discretion
to interpret statutes in order to effectuate this policy. EPA has long determined that
a "negligible risk" standard most effectively protects the health of the American
consumer and maintains the abundance of our nation's food supply.

TOLERANCE SETTING

CPDA strongly objects to the administration's proposal for a health-based safety
standard for setting tolerances which does not take into consideration benefits. A
"reasonable certainty of no harm to consumers of food" standard which the Adnainis-
tration proposes is no difierent in protection than existing law, which bars residues
which are unsafe" and only allows levels which are "necessary to protect the public
health." This new standard, however, does not take into account the wealth of eco-
nomic and public health benefits pesticides provide consumers.

The administration plan requires the consideration of other pesticide risks when
setting tolerances. For example, drinking water or nondietary exposures, risk of
other chemicals causing the same effect and risk to potentially sensitive subpopula-
tions would be considered. CPDA is opposed to this approach because it is purely
speculative as to when and how often the combination of these elements will affect
pesticide exposure in the food supply. We at CPDA believe that it is impossible to
derive a true, scientific measurement of the potential risks caused by such variables.

112

An approach which calls for the consideration of these fluctuating factors would in-
flate tne actual level of risk associated with the presence of pesticide residues in
foods.

The administration plan also requires EPA to assume high food consumption
rates at maximum residue levels to determine the safety factor for setting toler-
ances. The provisions of S. 1478 (which resemble those contained in the amended
version of H.R. 1627) are preferable, for these alternative initiatives take a more
realistic view of setting tolerances. EPA would be reauired under both S. 1478 and
H.R. 1627 to calculate the dietary risk posed to food consumers by a pesticide on
the basis of the percent of food actually treated with the pesticide and the actual
residue levels of tne pesticide that occur in food.

The administration is very committed to maintaining and enhancing food safety
for infants and children. Its proposals for tolerance setting respond directly to rec-
ommendations contained in the NAS report, "Pesticides in the Diets of Infants and
Children," that EPA consider unique aspects of children's diets and nondietary
sources of pesticide exposure.

CPDA fully supports comprehensive USD A funding to collect improved food con-
sumption data for children. We also believe that foods commonly consumed by chil-
dren should be a priority in residue monitoring. It should be noted, however, that
the NAS study indicated there are no identifiable problems with pesticide use in
children's food, but that more in depth studies need to be taken to fully understand
whether this conclusion is correct.

It is the administration's position that where children's data is not available, EPA
will employ "conservative estimates," unless the registrant can provide more accu-
rate data. It is important that tolerances which are soundly justified by scientific
evidence for the general population are not too greatly skewed by unproven sub-
population concerns. In addition, it is important that EPA take a close and reserved
look at considering nonfood exposures when setting food tolerances. A reliable cor-
relation between the two mav be difficult to implement on a consistent basis.

CPDA is opposed to legislation which, in the absence of adequate data on chil-
dren's food consumption patterns, allows EPA to utilize a "worst case" scenario
under which assumptions of maximum dietary exposure are made. CPDA supports
the more desirable alternative as set forth in the provisions of both S. 1478 and the
amended version of H.R. 1627 which would require EPA to establish tolerances on
the basis of the percent of food actually treated with the pesticide and the actual
residue levels of tne pesticide that occur in food.

TIMELY REVIEW AND ACTION ON EXISTING TOLERANCES TO ENSURE
COMPUANCE WITH THE NEW SAFETY STANDARD

A key provision in the administration's proposal is a fundamental change in the
approach to regulating the safety of pesticides in the food supply: a self-executing
statutory requirement that forces all tolerances to meet the new safety standard by
fixed deadlines. The Administration proposes that the review of all tolerances be
completed within 7 years after enactment of a legislative reform package, and that
pesticide tolerances that now appear not to satisfy the safety standard be subject
to special "fast track" review procedures.

The Agency presently has the means to review a pesticide tolerance if a problem
with the pesticide's use is apparent. CPDA does not believe the wholesale review
of every tolerance is a wise or appropriate allocation of EPA's limited resources.
Only if a legitimate concern exists, should a tolerance be reviewed. CPDA is opposed
to immediate cancellation provisions for those tolerances which have not met the
statutory deadline of 7 years but have not shown to be a bona fide health concern.
A review provision must exist for situations in which the manufacturer has not met
the burden in 7 years but no real health concerns have been shown to exist.

TIME-LIMITED TRANSITIONAL TOLERANCES

Under the administration's new tolerance review, however, EPA would have the
authority to maintain tolerances for a nonrenewable period of no more than 5 years
for a chemical that does not satisfy the strict health standard if justified to maintain
direct health benefits to consumers or to avoid significant disruption in the food sup-
ply. EPA should consult with the U.S. Department of Agriculture (USDA) concern-
ing any possible disruption in the food supply.

If a tolerance can justifiably be allowed to be used for 5 years because its benefits
clearly outweigh its risks, it should be permanently established at that level until
a suitable substitute is registered. The Clinton plan provides only for a 10-year pe-
riod for these tolerances to remain on the market. However, CPDA believes that no
time limits should apply to those tolerances which, if revoked, would create a sig-

113

nificant disruption in the food supply. The administration's 5-year tolerance exten-
sion is underlies the fundamental rationale that all benefits must be considered
when setting tolerances or registering pesticides. How can the Administration ig-
nore benefits and believe they are worth considering in some situations and for lim-
ited time periods, but not for all tolerances and all registrations?

INERTS

The administration's legislation to amend FFDCA, S. 2084, would revise the defi-
nition of a pesticide chemical to include inerts. A similar provision is contained in
S. 1478. We at CPDA are strongly opposed to any legislative language which would
expand the definition of a pesticide to include inerts. In fact, when the House Sub-
committee on Department Operations and Nutrition adopted its amended version of
H.R. 1627, it specifically rejected a provision which would have included inerts in
the definition of a pesticide. We at CPDA urge this Senate subcommittee to take
a similar position in opposing any legislation which would incorporate inerts into
the definition of a pesticide.

Under an amendment to section 201 (aXq)(l), the definition of a pesticide chemi-
cal is changed to also include all inert ingredients. The term "inert" should be de-
leted so that we can return to the original definition of a pesticide chemical. Under
this definition, future residue testing could include testing for all inert ingredients,
regardless of their level of toxicity.

All present residue testing for the current reregistration of particular crops and
uses could be invalidated for hundreds of pesticides and thousands of uses, many
of which are minor uses. Present residue testing studies for key metabolics (not
inerts) costs an average of about $150,000 per crop use per product. By adding all
inerts, the cost could jump $50,000 to $100,000 for each crop use for each product.

EPA has an extensive inerts program in which the Agency can require testing on
any or all inerts, and has established a priority program to examine inerts of toxi-
cological concern. In essence, EPA has the present authority to require any testing
of inerts it needs. By lumping all inerts together, there is no distinction between
the four categories of inerts, and no emphasis placed on inerts of toxicological con-
cern.

By driving up the cost of residue testing on all crop uses, we further jeopardize
minor uses, unnecessarily drive up the price of pesticide products to the American
farmer, and place the American pesticide industry at a serious comparative dis-
advantage in a competitive world marketplace.

We also place a massive burden on EPA resources to require review and decision-
making on all inerts, thus placing the Agency in an inflexible straitjacket that un-
necessarily drains money and manpower from already declining resources.

NATIONAL UNIFORMITY OF TOLERANCES

We at CPDA strongly support section 408(1) of S. 1478 because it establishes a
national uniform system of tolerances. Subsection (4) clearly states that "no State
or political subdivision may establish or enforce any regulatory limit on a qualifying
pesticide chemical residue in or on any food if a qualifying Federal determination
applies to the presence of such pesticide chemical residues in or on such food, unless
such State regulatory limit is identical to such qualifying Federal determination."
Similar language was adopted by the House Subcommittee on Department Oper-
ations and Nutrition in its recent markup of H.R. 1627.

THE NEED FOR IMPROVEMENTS IN EPA'S REGISTRATION PROGRAM

We cannot expect to promote interstate commerce in agricultural commodities,
or the processing, storing or transporting of a food, if we allow States or local poli-
tical subdivisions to impose their own tolerances for a pesticide chemical residue.
Otherwise, we could find ourselves in the unacceptable position of allowing States
or local governments to create barriers to interstate commerce, thus returning us
to the pre-U.S. Constitution days of the Articles of Confederation period in Amer-
ican history. Rather than returning to the 18th century, we need to plan for the 21st
century by adopting the national uniformity provisions contained in both S. 1478
and the amended version of H.R. 1627. Unfortunately, S. 2084 contains no similar
language.

We believe that EPA should channel its resources on implementing procedures
which would streamline and expedite the registration process for all chemicals. Over
the past several months, CPDA has worked closely with the Agency in developing
a set of proposals which would help streamline the OPP registration program. Our
association nas submitted to EPA a detailed proposal which makes recommenda-
tions pertaining to the coordination and streamlining of pesticide labeling, uniform-

114

ity in the review of data requirements, the expansion of the Agency's notification
process to allow for registrant certification of simple registration amendments, the
need to fix "fast track," and the creation of single registrations for identical products
in different packaging. We at CPDA believe that reform in these areas will facilitate
the availability of safe, beneficial and efiective products and, at the same time, will
remove many of the barriers which now exist in bringing a product onto the market.
CPDA would like to point out that some of these initiatives have been incor-
porated into the package of amendments adopted by the House Subcommittee on
Department Operations and Nutrition in its recent markup of pesticide legislation,
H.R. 1627. CPDA would like to take this opportunity to detail several of the initia-
tives which we have proposed to EPA.

SINGLE REGISTRATIONS FOR IDENTICAL FORMULATIONS IN
WATER SOLUBLE PACKAGING

For many years the Agency has allowed difTerent products of identical formulation
to be registered under one "master label" at the Agency. Administratively, this pol-
icy made sense, for these products were the same pesticide, but were marketed in
difierent package sizes.

Recently, however, the Agency has required product amended to be sold in dif-
ferent packaging or sizes to maintain its own separate registration. For example,
products packaged in water soluble packaging and rodenticides packaged in closed
"place pack" containers were required to maintain their own registrations, separate
from the registration already established for the exact same pesticide product.

Unfortunately, this policy has dissuaded companies from marketing new products
with safer packaging because of the high State and Federal fees for maintaining a
registration. The Agency's emphasis on safer pesticides, reduced levels of user expo-
sure and decreased container waste, should however, make these technologies lead-
ing candidates for promotion at the Agency.

To streamline the process for registering products with the same active ingredi-
ents and same formulation, but witn different packaging, so as to not require a sep-
arate registration, CPDA urged the Agency to establish procedures for registrants
to notify the Agency about changes in packaging.

The main purpose of this expanded notification process is to avoid the unneces-
sary duplication of the registration process, to utilize the master label concept with
the ability to split the label, and to allow the Agency to utilize its limited financial
resources and declining manpower pool on other, more risk related issues.

The unnecessary duplication of the registration process discourages innovative
ideas in packaging, delays market entry, and increases fees at the Federal and State
levels. By promoting new packaging, such as water soluble bags, it is possible to
promote a closed system approach that enhances safety by reducing mixer loader
exposure for agriculture products. It also complements the Agency's effort to reduce
the number of nonrecyclable pesticide containers and at the same time reduce the
unnecessary use of hazardous landfills. In addition, cereal rodenticides which are
sold in place packs and wax block and rodenticides which are sold precut reduce
exposure to consumers and users.

Existing EPA policy does not encourage or provide incentives for safer, more effi-
cient packaging. In fact, it discourages new innovations in packaging by requiring
separate registrations, delayed market entry, and increased fees at the Federal and
State levels.

Although EPA has consistently held a policy of promoting pesticides with reduced
risk or "safer pesticides," and has recently promulgated new container regulations
to reduce the number of pesticide containers and reduce exposure, it has not taken
similar initiatives for water soluble packaging.

Utilizing water soluble packaging to loaa crop protection chemicals into spray
tanks will result in a "closed" system that will significantly reduce mixer-loader ex-
posure as opposed to the "open-pour" methods.

Across the board, it also reduces container disposal, solid waste collection, and uti-
lization of land fills. By shifting from a liquid to a dry powder, with a water soluble
bag, there is an inherent increase in safety concerning accidents, spillage, and a pos-
sible reduction in groundwater contamination. It is far easier to cleanup a breakage
or spill if the product is in a dry form, compared to a liquid form.

Although rodenticide registrants are utilizing the same active ingredient, same
formulation, they are attempting to develop innovative packaging concepts to meet
consumer demands. The Agency has been requiring separate registrations for cereal
bait formulations packaged in "^ulk containers" or in small packs, commonly known
as "place packs." The application directions differ for bulk bait, which requires

115

placement in terms of ounces, whereas those for "place packs" are described by the
number of packs.

In another example, one formulation of a paraffin based "all-weather" rodenticide
block bait, which is scored to be broken by the user is commonly required to have
a separate registration number from a product with the same formulation which is
sold precut into pieces. The only difference between the products is that the appUca-
tion directions for the first product include instructions for breaking the bait. If the
Agency feels that different application directions are needed to promote consumer
health and safety, registrants do not oppose putting diflerent directions on different
sizes. But many insecticides and many consumer products provide different direc-
tions for users without requiring separate registrations. In fact it is common place
for Agency registered products to have one registration number for different sized
packages of the same products.

Current regulations require the registrant to seek a new separate registration for
each product utilizing water soluble packaging. Even if the registrant is utilizing the
same active ingredient, the same formulation, with the same level of toxicity, the
Agency is arguing that two package types cannot utilize the same EPA registration
number if the use directions are difierent. It is important to note the site and dos-
age rates are usually the same, only the mixing instructions are different. For exam-
ple, rather than require one quarter pound per acre, the registrant is requiring X
number of packets per acre or X number of packets for Y number of acres. For crop
protection chemical the registrant is attempting to restate the use directions by
shilling the mixing instructions, not the site or dosage rate.

By requiring a separate registration for each "new" water soluble packaging prod-
uct or difierent rodenticide size/shape, the Agency is delaying market entry by one
to 2 years, and forcing registrants to go through the costly and timely registration
process.

The Agency is also utilizing its resources, both financial and manpower, to review
and approve these additional registrations at a time of declining budgets and man-
power allotments. By streamlining existing procedures, the Agency could save enor-
mous resources, while preventing the unnecessary duplication of registrations.

Each registrant must pay additional fees at the Federal and State levels for each
"new" product. At the Federal level, it requires $1,300 for each product in additional
maintenance fees. If also registered in 50 States, it can cost up to $5,500 in State
fees for each product.

EPA has recently notified CPDA that it intends to issue a PR Notice which will
allow single registrations for identical products in water soluble packaging. CPDA
is pleased that the Agency is taking this action. We believe that this action will help
reduce the disposal of containers, reduce exposure to mixer-loader employees, reduce
the amount of Agency time spent on reviewing these registration applications, and
save pesticide registrants as much as $50,000 to $100,000.

THE NEED TO FIX "FAST TRACK"

For almost 6 years, the EPA has been implementing the provisions of the 1988
FIFRA "Lite" amendments, but has not been able to clear tne backlogs that exist
in the registration division. This backlog especially impacts "Fast Track" or "expe-
dited review" products, despite Congressional authorization for up to $2 million per
year of reregistration maintenance fees to be used to implement "last track."

On the front-end review process, the Agency has done an adequate job of review-
ing the original documents and determining if they are in order and complete. This
initial review has usually been completed in 45-days. The second phase — requiring
90 days — provides for the finalization and approval or rejection of an "expedited re-
view" application. It appears that "an expedited review" product gets no special han-
dling in this second phase. It seems simply to go to the bottom of the pile.

The "ninety day" second phase has taken anywhere from 6 to 18 months, with
some isolated examples that required more than 2 years. The Agency has not moved
quickly enough to solve these "fast track" problems. Some simple label changes,
such as alternative brand names or the addition of alternate sources of supply to
a confidential statement of formula, that take 15 minutes to review, instead, take
6 months to filter through the process. Many label changes need only prompt re-
sponses, without delegation of responsibility. We see little evidence that the Agency
has moved quickly enough to put the appropriate personnel in place to handle this
workload.

We believe that existing resources within EPA's OPP should be utilized to address
"expedited review" backlogs. Assignments of specific personnel to handle expedited
review should be made. For example, one person on a product manager's team
should be designated for expedited review. When he or she is caught up, then, he

116

or she could return to other team assignments. The amount of time needed would
vary from team to team, depending on the number of cases to be handled.

Under present handling of "me-too" applications or simple amendments, each of
these expedited review applications is placed in one stack with all other applica-
tions. There should be two stacks — one for expedited review, and another for other
applications.

Many "me-too" applications simply take too long to review. Frequently, each appli-
cation goes through a seven step review process, each of which is time consuming.
Rather than a seven step process, a first level reviewer should be given the author-
ity to complete the process.

To facilitate the quick identification of expedited review applications, the applica-
tions should be more easily recognized by color coding the application.

If the Agency fails to comply with the 90-day deadline, for whatever reason, it
should provide the registrant with an up-date, and an expected timetable for com-
pletion. Without this type of status report, registrants cannot make normal business
decisions or marketing plans.

We at CPDA believe that section 112 of H.R. 1627, entitled "Requirements for
Registration of Substantially Similar or Identical Pesticides and Antimicrobial Prod-
ucts," addresses many of the present shortcomings of the 'Tast Track" system. We
at CPDA would strongly urge this Senate subcommittee to give some serious consid-
eration to the merits of legislative language contained in section 112 of H.R. 1627.

THE NEED TO EXPAND THE AGENCY'S NOTIFICATION PROCESS

In order to reduce the backlog in registration applications at the Agency, we at
CPDA believe that the notification process should be broadened in order to expedite
common product amendments which do not involve the introduction or increase in
risk. We have recommended that the Agency establish a certification process bv
which a registrant could certify that its registration application meets the Agency s
requirements and regulations for registration. The following are just a few examples
of the types of registration amendments which could be accomplished through notifi-
cation:

• New areas (site and pest) of use within the same category not requiring addi-
tional data;

• Use precautions related solely to a registrant's liability for efficacy, crop dam-
age, or compatibility;

• nonsubstantive label changes which do not effect the safety or manner in which
the consumer understands how to use the product;

• EPA initiated label changes and environmental marketing descriptions subject
to FTC restrictions; and,

• Changes in inert ingredients.

THE NEED TO ACHIEVE A MORE EFFECTIVE REVIEW OF DATA

We at CPDA believe that the Agency can streamline and improve data review by
adopting the following suggestions:

• Notification or self-certification of acute toxicity studies, except for inhalation
and dermal sensitization;

• Review and approval of data protocols in a timely manner;

• Early warning system for registrants; dialog on issues as they arise; early con-
sultation on PR Notices;

• Consistent review of toxicity studies; and,

• EPA's precautionary labeling reviewers need to follow the stated Agency posi-
tions in the toxicology rejection rate criteria document.

At a time of limited Agency financial resources and declining manpower, it is im-
portant that the Agency do more with less, while not impairing risk or adversely
afiecting man and the environment. We at CPDA believe that the recommendations
set forth here in our testimony will help the Agency achieve this goal.

PUBLIC HEALTH PESTICIDES

In its provisions on pesticide minor uses, S. 2050 includes a provision, wholly sup-
ported by CPDA, whicn recognizes the need to protect the continued availability of
Eublic health pesticides. As such, the administration's legislation would direct the
lepartment oi Health and Human Services and EPA to collaborate in identifying
critical public health minor uses that might otherwise be lost, and to arrange for

117

necessary data support, with HHS adopting a role similar to that filled by USDA's
IR-4 Program for agricultural minor uses. S. 2050 authorizes appropriations of
$12,000,000 for fiscal year 1993 to be used by the Secretary of Health and Human
Services in providing support for the required studies needed to continue the reg-
istration of public health pesticides.

CPDA applauds the public health pesticide provisions contained in S. 2050. In
supporting the administration's provisions on puolic health pesticides, we would also
recommend that the subcommittee incorporate into any FIFRA amendment package
the provisions of H.R. 1867, introduced by Representatives Dooley and Herger dur-
ing this 103d Congress. CPDA would like to point out that the language of H.R.
1867 and the administration's provisions on public health pesticides were adopted
by the House Subcommittee on Department Operations and Nutrition in amending
H.R. 1627 during its recent FIFRA markup.

Titled the "Public Health Pesticides Protection Act of 1993," H.R. 1867 embodies
many of the concepts set forth in the public health provisions of the administration's
bill. We believe that H.R. 1867 afrord.s appropriate protection for many of these low
volume products which are critical to preserving the public health. The Dooley-
Herger bill ensures that EPA establish guidelines that take into consideration the
need for and benefits of public health pesticides used to combat disease-carrying in-
sects and pests and to ensure that these products are not lost in the reregistration
process due to economic reasons alone.

The Dooley-Herger bill contains provisions which would:

• Define public health pesticide uses in the context of minor uses;

• Create a separate class of pesticide registration for public health pesticides with
a risk-benefit balance, which is separate from that utilized for agricultural pes-
ticides;

• Require that the EPA Administrator take into consideration "the differences in
concept and usage" between agricultural, nonagricultural, and public health
pesticides;

• Reauire consultation by the EPA Administrator with the Secretary of Health
ana Human Services on pesticides for public health uses, similar to the existing
consultation between EPA and USDA; and,

• Expedite the registration of products necessary for the protection of public
health.

On April 23, 1991, Dr. WiUiam Hazeltine, Manager-Environmentalist of the Butte
County Mosquito Abatement District in California, appeared before Members of the
House Subcommittee on Department Operation's Research and Foreign Agriculture.
More recently, he appeared before the House Subcommittee on Department Oper-
ations and Nutrition on June 8, 1993 during FIFRA oversight hearings. During each
of his Congressional appearances. Dr. Hazeltine eloquently drew attention to the
need to create a public health provision in FIFRA, with an emphasis on controlling
diseases transmitted by mosquitoes and other vectors.

Dr. Hazeltine's June 8th testimony states, "... It should be obvious that for
good mosquito and other vector control programs to continue, professional public
health decisionmakers need to have a wide array of choices available to them, so
that they can select the best material or method for use when control becomes nec-
essary. If pesticides are not registered by the Federal Environmental Protection
Agency (EPA) they are not going to be available for use to protect the Public's
Health. While we continually look at a wide range of control alternatives, we recog-
nize the need for effective pesticides which are registered and available for our use."

We would also like to point to the comments of Dr. John Graham which were
shared with the House Subcommittee on Department Operations and Nutrition on
July 14, 1993. Dr. Graham is Professor of PoUcy and Decision Sciences at the Har-
vard School of Public Health and founding Director of the Harvard Center for Risk
Analysis. Dr. Graham's July 14th testimony makes a very convincing case for the
human health benefits associated with the use of many pesticides. He states,
"... In some situations, the loss of a pesticide may cause direct harm to public
health as a result of consumer exposure to the fungi that thrive without the pes-
ticide. For example, although many fungicides have oeen shown to cause cancer in
animals at high doses, some of the toxins produced by fungi, such as aflatoxin, are
also known to cause cancer. One of the benefits of pesticides is the human health
protection resulting from destruction of fungi."

Many CPDA companies manufacture, formulate and distribute insecticides and
rodenticides that attack mosquitoes, flies, ticks, mites, fleas and other insects, rats
and other rodents, and that promote public health. Many of these companies, there-
fore, emphasize nonagricultural pesticide production and public health issues. Be-

118

cause we share Dr. Hazeltine's concern about public health issues, we at CPDA be-
lieve that the public health pesticide provisions of H.R. 1867 should be adopted as
an amendment of FIFRA.

In summary, the Dooley-Herger bill recognizes the unique benefits of low volume
minor use pesticide products which are widely used in public health programs to
combat a host of insects and pests which transmit harmful diseases to man. It is
critical that a wide variety of product choices be made available in order to maintain
good mosquito and other vector control programs. Without proper public health pro-
grams, vector borne diseases such as malaria and yellow fever might once again be-
come epidemic in the United States. We believe that the provisions contained in the
Administration bill if adopted in combination with the Dooley-Herger bill will help
ensure that this never happens.

OTHER IMPORTANT PESTICIDE LEGISLATIVE ISSUES

Additionally, we would like to comment on five other pesticide issues: (l)"Me-too"
certification; (2) preemption; (3) synchronization and coordination; (4) minor use; and,
(5) minor use and data compensation.

"ME-TOO" CERTIFICATION

The 1988 FIFRA "Lite" amendments mandated that the Agency establish a "fast
track" or expedited review of "me-too" registrations and simple amendments (label
changes), but the Agency has never fully implemented this provision. We strongly
support section 112 of the amended version of H.R. 1627. This provision incor-
porates many of the initiatives advocated by the Antimicrobial Industry Coalition,
that creates a certification registration process for substantially similar or identical
pesticides. This important reform will expedite pesticide registrations and dramati-
cally reduce the amount of Agency resources needed to register these products.

PREEMPTION

We at CPDA would like to express our support for legislation which would pre-
empt local jurisdictions from enacting their own rules governing the sale and use
of pesticide products. We believe that such regulatory authority over pesticides
should be limited to a partnership between Federal and State governments which
have the appropriate mechanisms in place to promulgate uniform, sensible regula-
tion based on sound science.

On June 21, 1991, the Supreme Court issued its decision in the case of Wisconsin
Public Intervenor v. Mortier. In its opinion written by Justice White, the Supreme
Court ruled that local jurisdictions are not preempted by FIFRA from enacting their
own pesticide ordinances. In essence, the Court's decision threatens to undermine
the existing Federal-State partnership of pesticide regulation by opening up the
field of regulation of these products to more than 80,000 units of local government.

At its July 27, 1994 FIFRA markup of H.R. 1627, the House Subcommittee on
Department Operations and Nutrition passed an amendment which prohibits local
governments from imposing any requirements or regulations regarding pesticides.
The legislation, however, does not prohibit a State from enacting laws or implement-
ing regulations applicable to local governments regarding the sale or use of any reg-
istered pesticide. This provision is identical to an amendment offered by former Rep-
resentatives Charles Hatcher (D-GA) and Ron Marlenee (R-MT) during the May
1992 markup of FIFRA conducted by the House Subcommittee on Department Oper-
ations, Research and Foreign Agriculture (DORFA). At that time, CPDA and other
members of the Coalition for Sensible Pesticide Policy, a broad-based industry alli-
ance, fought very hard for the inclusion of the Hatcher-Marlenee language in
FIFRA.

We remain committed in our support of legislation which would revise FIFRA to
prohibit the local regulation of pesticides and urge the subcommittee to adopt the
language contained in the amended version of H.R. 1627.

COORDINATION AND SYNCHRONIZATION OF FEDERAL/
STATE DATA REQUIREMENTS

We at CPDA strongly support legislation that would facilitate an increase in co-
ordination and synchronization between the various States and the U.S. Environ-
mental Protection Agency. Legislation to achieve these goals was introduced on No-
vember 22, 1991 (H.R. 3882, the "Pesticide Data Coordination and Synchronization
Act of 1991") by Congressmen Steve Gunderson (R-WI) and Pat Roberts (R-KS). An
identical measure was adopted by the House Subcommittee on Department Oper-
ations and Nutrition in its July 27, 1994 markup of H.R. 1627.

119

In 1984, California passed S.B. 950 to require the filling of pesticide data gaps,
for all products, including lawn care chemicals. To implement this law, the State
adopted a definition of a "data gap," created a list of tests that need to be completed,
and established a detailed timetable for filling these data gaps.

The State legislature, however, did not take into consideration the attempt of the
Congress to create their own reregistration timetables when it amended FIFRA in
1988. FIFRA "Lite" was also designed to fill these same data gaps. This is a new
and growing problem. Several States are now considering such legislation and Ari-
zona has followed California's example.

The bill, according to Representative Gunderson, would have required EPA to "co-
ordinate and synchronize" data requirements at the State and Federal levels so as
to "avoid unnecessary repetition and redundancy."

Representative Gunderson stated that the legislation "calls for communication
and consultation concerning requirements for generation and review of specific data
between State and Federal regulatory agencies, and will foster but not require uni-
formity."

In his remarks, appearing in the November 22, 1991 Congressional Record, Rep-
resentative Gunderson said that by "reducing the increased pricing associated with
the cost of unnecessary and redundant testing," the measure would help farmers
and consumers faced with the rising cost of pesticide products.

"To illustrate the need for this legislation," the Congressman stated, "it is impor-
tant to note that States have been adopting laws to establish programs for filling
health and safety data gaps on pesticides registered within its borders."

"In some cases," he continued, 'lay establishing a list of required studies, and by
creating a timetable for filling these gaps, the States will disregard the efforts of
EPA to establish reregistration timetables and data call-ins to fill some of these very
same data gaps."

'In essence," Representative Gunderson stated, "in attempting to establish their
own expedited reregistration programs to fill data gaps, the States may establish
their own data requirements, and those requirements can be at odds with EPA's
and cause hardship for both active ingredient manufacturers and formulators of pes-
ticides. Additionally, standards of review of existing or newly generated data may
difi-er."

"Unnecessary repetitive and redundant testing not only consumes valuable time
and resources, " the Congressman stated, "but also delays the closing of data gaps.
Valuable time and resources which could be used to develop new data are wasted
in refocusing on gaps that have already been or are in the process of being filled."

In his statement. Representative Gunderson also noted that many low-volume,
low-profit specialty products, including antimicrobial products, may be discontinued
because neither the registrant, the formulator, nor the State will pay for additional
tests required on active ingredients.

"Many nonagricultural, minor use products also could disappear," he said. "Unre-
alistic timetables for implementing and generating these needed studies could cause
some of these products to be dropped from the market."

Concluding his remarks. Representative Gunderson stated that, "With adoption of
this provision, pesticide manufacturers can make well-reasoned decisions as to the
generation of additional data. The entire process of filling data gaps will be greatly
enhanced through the exchange of information between State and Federal toxi-
cologists and other regulatory officials."

Coordination and synchronization legislation would help reduce the cost of pes-
ticides, including lawn care chemicals, eliminate duplicative and unnecessary test-
ing, expedite the closing of data gaps and make sure that pesticides for farmers and
consumers, especially minor use products, will be available wherever needed.

We at CPDA are pleased that the provisions of Congressman Gunderson's legisla-
tion from the 102d Congress (H.R. 3882) has been incorporated into H.R. 1627, as
amended by the House Subcommittee on Department Operations and Nutrition. We
would urge this Senate subcommittee to adopt similar legislation in considering any
amendments to FIFRA.

MINOR USE

CPDA supports the concept of the Minor Crop Pesticides Act of 1993, S. 985, in-
troduced during the 103d Cfongress by Senator Daniel K. Inouye. Identical legisla-
tion, H.R. 967, was introduced by Representative E. (Kika) de la Garza, Chairman
of the House Committee on Agriculture. The provisions of H.R. 967 have been adopt-
ed as part of the package of amendments to FIFRA legislation, H.R. 1627, during
a House Subcommittee on Department Operations and Nutrition markup.

120

The retention of minor use pesticides used on low volume commodities should re-
main a key focus of Congress in the reauthorization of FIFRA. Minor crops grown
in the United States constitute an industry with estimated sales of $35 billion at
the farmgate. These include hundreds of different crops ranging from daily foods
(fruits, vegetables, and nuts) to a variety of specialty items (flowers, hops, herbs,
trees, shrubs, and turO.

As you know, under the 1988 amendments to FIFRA, the U.S. Environmental
Protection Agency was charged with reviewing some 600 agricultural chemical ac-
tive ingredients as part of its 9-year accelerated reregistration program targeted for
completion in 1997.

Since its inception, we have witnessed a dramatic reduction in the number of
minor use pesticide registrations. To date, 34 percent of the products originally reg-
istered have been dropped. The majority of these product registrations have been
held by small companies. The financial burden of maintenance and reregistration
fees in combination with the enormous costs of generating the necessary data to
support the continued registrations of these chemicals have contributed to their de-
cline. Today, a number of crucial products remain at risk of disappearing from the
marketplace.

EPA's accelerated reregistration program has subjected registrants to a number
of data submission requirements in defending pesticide registrations for use on
minor crops. The costs associated with fulfilling these requirements is formidable
when one considers that for each active ingredient, there may be a number of dif-
ferent product formulations used on a wide variety of crops.

The members of CPDA see S. 985 as a step in the right direction to ensure cost-
effective chemicals remain available for use on low volume commodities. S. 985 sup-
plies the flexibility to EPA in addressing minor use registrations. Time extensions,
waivers, use of surrogate data, and the creation of a fast track process for these reg-
istrations provides the mechanisms needed to support the continued uses of these
valuable chemicals. At the same time, the bill conditions these allowances on the
certainty that there will be no unreasonable adverse effects on man or the environ-
ment.

Moreover, the measure adopts a very broad definition of minor use, encompassing
uses of a pesticide on animals, commercial agricultural crops and public health pes-
ticides. A determination of minor use activity is based on economic incentives, rath-
er than on specific acreage requirements, a threshold found in previous minor use
bills. As such, current EPA policy is ratified.

Furthermore, we support the creation of minor use programs in both EPA and
USDA. Programs of tnese sort will help in coordinating policies, consulting with
growers and tracking and expediting minor use registrations.

MINOR USE AND DATA COMPENSATION ISSUES

We believe that the mechanisms found in S. 985, such as extensions, certain waiv-
ers and use of surrogate data, in conjunction with the present data compensation
provisions found in FLFRA, provide ample incentive for pesticide registrants to sup-
port these chemicals through the reregistration process and in developing new ac-
tive ingredients.

While we support the major provisions of S. 985 and its counterpart in the House,
H.R. 967, we believe the extension of time periods for exclusive use of data will not
assist minor use protection, and, in fact, will actually exacerbate the problem.

The pesticide industry is similar in many ways to the pharmaceutical industry.
Under FFDCA, there are limited provisions which grant patent term extension to
cover, in part, some of the time lost in the FDA registration process, but it also in-
cludes provisions for generic drug registration, the elimination of data compensation
provisions, and permits the testing of potential products 2 years prior to the expira-
tion of the patent. These arrangements create a balanced package for both basic
manufacturers and generic drug producers.

Currently, under FIFRA we find that in addition to the initial patent, the data
used by a generic producer are compensated not at cost but at fully loaded value
with market considerations such as early market entry. If Congress selected to ex-
tend the period of exclusivity, the result would be an unfair and inequitable solution
that would only drive up the cost to farmers, ranchers, consumers and pesticide end-
users. Moreover, it would destroy competition in the marketplace and would dis-
proportionately impact small businesses that formulate or distribute many regional
or local products.

We believe that these exclusive use provisions should be rejected for the following
reasons:

121

• It will artificially inflate the costs of nearly all pesticides and create a 10-year
period where the registrant can maintain a high price for all consumers and
pesticide uses. This provision will affect millions of farmers, as well as countless
millions of consumers who treat their lawns, shrubs, trees, and gardens.

• This 10-year exclusive use period will broadly aflect most food use pesticides,
including most of the List A and B food use products currently being
reregistered.

• It will create a monopoly for basic registrants that will deny formulators and
distributors an opportunity to market their products for specific minor uses and
prevent entry into the market.

• It will create an economic disincentive to market existing products. For exam-
ple, dealers and distributors will probably want to carry a product with the
largest number of uses, and would not carry a product with 5, 10 or 15 fewer
minor uses. In essence, a formulated product with fewer uses would be at a
competitive disadvantage in the market place.

• It would extend protection far beyond patent term and provide de facto patent
term extension.

• This period of exclusive use would particularly impact old chemicals being
reregistered, and could effectively deny formulators and distributors entry into
the local and regional markets for minor use products.

• The provision covers all data which solely supports a minor use. It is not re-
stricted to just residue data.

• This provision is unneeded and unnecessary because sufficient economic incen-
tives for data production for minor uses already exists under the EPA PR Notice
94_1 which provides for protection of data and compensation for that data.
Under section III of the Notice entitled "Data Compensation Rights of Persons
Who Develop Data," EPA affirms that "data developers who develop generic or
use-specific data in support of registration or reregistration of a product are en-
titled to the same data compensation rights as MP registrants that develop such
data. They may request that they be identified on the Agency's Data Submitters
List, as wanting data compensation from registrants who use their data in sup-
port of registration. The request to be added to the Data Submitters List should
include the name of the active ingredient, data for which compensation is re-
quired, and their firm's name and address." Please see an attached copy of PR
Notice 94-1 as an appendixes to this testimony.

• This provision has a disproportional economic impact on small businesses that
produce, formulate and distribute local and regional products for specific minor
uses.

• Most importantly, this provision reopens the controversial Congressional delib-
erations over data compensation, generic data registration, patent term exten-
sion, and roll-back of the Bolar v. Roche decision that occurred in the 1980's.
It devises a program that one-sidedly benefits large basic producers, and creates
significant economic disadvantages for small producers, formulators and dis-
tributors and denies them an ability to compete in the marketplace.

Conclusion

We at CPDA respectfully urge the Senate Subcommittee on Agricultural Re-
search, Conservation, Forestry and General Legislation to conduct a markup of
FIFRA as soon as possible. We strongly support S^ 1478 for its treatment of Delaney
and tolerance setting, as well as cancellation and suspension. We ask that this sub-
committee develop Senate language which would incorporate the provisions of H.R.
1867, the Dooley-Herger bill on public health pesticides. Similarly, we at CPDA rec-
ommend that this subcommittee adopt provisions found in H.R. 1627, as amended
by the House Subcommittee on Department Operations and Nutrition. Specifically,
CPDA supports those House provisions which address: 1) restrictions on local gov-
ernments from regulating the sale and use of pesticides; 2) the coordination and
synchronization of data between Federal and State agencies; 3) certification of "me-
too" registrations; and, 4) labeling reform within EPA. In addition, we support Sen-
ator Inouye's minor use bill (S. 985), except for the provisions on 10 years of exclu-
sivity. We strongly support fixing the registration and reregistration process so that
products can be handled in an efficient, effective and expedited manner. We also
STipport portions of S. 2050 and S. 2084, the administration's legislation to amend
FIFRA and FFDCA, respectively, especially the public health provisions. We ap-

22 See page 122.

122

plaud this Senate subcommittee for its leadership on pesticide issues and look for-
ward to working with its members during the 103d Congress. We respectfully urge
this subcommittee to draw on the best of the FIFRA and food safety legislative pro-
posals which have been introduced in both the House and Senate as it proceeds in
crafting a fair and reasonable pesticide reform package.

[APPENDIX]

NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS, DISTRIBUTORS, AND
REGISTRANTS OF PESTICIDE PRODUCTS

Effective immediately, EPA is withdrawing PR Notice 91-8, entitled "Revised Pol-
icy To Provide Applicants Other Than Basic Manufacturers An Opportunity To Sub-
mit Generic Data and Receive Data Compensation For It. That notice requested the
use of a generic label statement on manufacturing use product (MPs) to effect this
policy. Persons who have complied with PR Notice 91-8 may retain such statements
or may delete them from product labeling, at their discretion.

BACKGROUND

In the mid-1980's, the Agency developed a policy for Manufacturing Use Product
(MP) labeling that uses supported by the MP registrant should appear on the label
and that reformulation for other uses should be prohibited. During pesticide rereg-
istration many MP registrants have elected not to develop data in support of some
label uses of their products, especially the minor uses. In accordance with Agency
policy, these uses must be removed from MP product labeling.

Certain grower groups and end-use formulators have decided to fill the void them-
selves by submitting generic data to support the registration or reregistration of
those minor uses. However, the Agency's policy for MP labeling could have the unin-
tended consequence of denying these user groups and formulators compensation
from other formulators for this data as provided under the Federal Insecticide, Fun-

ficide, and Rodenticide Act (FIFRA), section 3(c)(1)(F). Because the Agency's MP la-
ding policy prohibits an unsupported use from appearing on an MP label, these
user groups and formulators must provide the data they intend to generate to an
MP registrant in order to ensure that an MP can be reformulated lawfully for the
minor uses that the data support. Once the MP is supported for such uses, however,
other formulators using the MP may claim the formulator's exemption for those
uses, thereby denying compensation to the user groups or formulators that devel-
oped the data. Therefore, several end-use registrants and user groups requested
that the Agency establish a mechanism to ensure that the data compensation rights
of grower groups and formulators generating minor use data are retained.

PR Notice 91-8 was the Agency s attempt to ensure compensation for data devel-
oped by grower groups or formulators by requesting MP registrants to include an
additional generic labeling statement that permits reformulation of their products
for uses other than those specifically listed on the MP label and supported by the
MP registrant, provided the formulator supports such uses. This statement pre-
serves the data compensation rights of grower groups or end-use formulators be-
cause the labeling statement would effectively prevent other formulators that did
not develop data from claiming the formulators exemption for specific uses sup-
ported by user groups or end-use formulators.

These same end-use registrants and user groups have now advised the Agency
that MP registrants should not be required to adopt the generic labeling statement
set forth in PR Notice 91-8. These groups have joined with the representatives of
MP registrants in advising the Agency that MP registrants should be able to control
the uses made of their products by controlling the MP label. They indicated that
the user groups and end-use formulators must work in cooperation with the MP reg-
istrants before developing the necessary data to sustain a use which the MP reg-
istrant no longer intends to support. These groups, have, however, asked that the
Agency affirm that the formulators, coalitions, manufacturers and grower groups
that develop basic data are entitled to data compensation should another person
rely on such data to obtain a registration.

AGENCY ACTION

Because representatives of grower groups and end-use formulators who requested
PR Notice 91-8 believe that the Agency snould not require MP registrants to adopt
the label statements set forth in tne Notice, the Agency sees no reason to continue
the policy. Accordingly, the Agency withdraws PR Notice 91-8 and will not require
MP registrants to incorporate the generic labeling statement set forth in PR Notice
91-8.

123

DATA COMPENSATION RIGHTS OF PERSONS WHO DEVELOP DATA

Although EPA is withdrawing PR Notice 91-8, it is not abandoning the principles
underlying the notice. EPA aflirms that data developers who develop generic or use-
specific data in support of registration or reregistration of a product are entitled to
the same data compensation rights as MP registrantsthat develop such data. They
may request that they be identified on the Agency's Data Submitters List, as want-
ing data compensation from, registrants who use their data in support of registra-
tion. The request to be added to the Data Submitters List should include the name
of the active ingredient, data for which compensation is reouired, and their firm's
name and address. Submit such requests to Ms. Sherada Hobgood at the address
under VI below.

REGISTRANT ACTION

MP registrants who have complied with PR Notice 91-8 may continue to use the
label statement set forth in the notice ^, or may delete it at their discretion. No no-
tification is required solely for this purpose.

Any MP registrants wishing to do so may add one of the following statements to
an MP label under "Directions for Use" to permit the reformulation of their product
for a specific use or aU additional uses supported by a formulator or user group.
Furthermore, provided no other labeling changes are made, no notification to the
Agency is required.

(a) "This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has com-
plied with U.S. EPA data submission requirements regarding the sup-
port of such use(s)."

(b) "This product may be used to formulate products for any additional uses
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA data submission requirements regarding the
support of such uses."

Note: This notice does not alter the Agency's basic labeling policy that MP reg-
istrants include a specific list on the label of those uses for which the MP may be
reformulated.

Effective Date: Efiective immediately PR Notice 91-8 is withdrawn.

Additional Information: For further information, please contact — ^Rosalind L.
Gross, Registration Support Branch, Registration Division (7505-W), EPA, 401 M
Street, SW, Washington, DC. 20460, (703) 308-8354.

POSITION STATEMENTS

The National Association of State Departments
OF Agriculture

The National Association of State Departments of Agriculture (NASDA) is pleased
to submit testimony for the record on the matter of pesticide regulation reform.
NASDA is the nonprofit association of public officials representing the Commis-
sioners, Secretaries and Directors of Agriculture in the 50 States and the territories
of American Samoa, Guam, Puerto Rico, and the Virgin Islands. As the Chief State
Agriculture Ofiicials, NASDA's members are keenly aware of the importance of bal-
ancing agricultural production and natural resource conservation on their State's
and the Nation's economy.

In most cases, under a cooperative agreement with the Environmental Protection
Agency (EPA), the State Departments of Agriculture serve as the Lead State Pes-
ticide Regulatory Agency in each State. Therefore, NASDA brings a unique perspec-
tive on pesticide regulations and the reauthorization of the Federal Insecticide, Fun-
gicide and Rodenticide Act (FIFRA). NASDA members represent the frontline pes-
ticide regulators who must balance human health and environmental protection

""Only for formulation into an , [fill blank with Insecticide, Herbicide, or the applica-
ble term(s) which describes the type of pesticidal use(8)]. For (1) the following U8e(s):

(fill blank(s) with only those uses that are being supported by the MP r«^strant or applicant.)
Conclude this statement by adding. (2) Uses for which U.S. EPA has accepted the required data
and/or citations of data that the formulator has submitted in support of registration; and
(3) Uses for experimental purposes that are in compliance with U.S. EPA requirements."

124

with farmers' needs, and face the State and local anxiety over pesticide use and reg-
ulation.

BACKGROUND

Under FIFRA, EPA is responsible for registering pesticides using risk-benefit
analysis to ensure that pesticide use will not result in unreasonable adverse effects
on health or the environment. EPA registers a pesticide only if it determines that
it will not cause any "unreasonable risk to humans or the environment, taking into
account the economic, social, and environmental costs and benefits of the use of
[the] pesticide. " Basically, registrations are licenses for specific pesticide uses that
state the terms, conditions and cautions of these uses.

To register a pesticide, EPA requires the manufacturer to provide health and en-
vironmental effects data, product labeling information, a confidential statement of
the chemical formula of the pesticide, and child-resistant packaging (if applicable)
to EPA's Ofiice of Pesticide ft-ograms. Registration Division. It may take the appli-
cant a few months to several years to gather the necessary data because of the time
involved in completing the research required to obtain a registration. The Registra-
tions Division decides to approve or deny the registration after reviewing a complete
application. This process can take an average of 2 years if all the necessair data
have been provided, but much longer if data is incomplete and additional data is
needed.

Separate legislation guides the setting of tolerances for residues of pesticides reg-
istered under FIFRA. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires
EPA to establish tolerances — the maximum limits of pesticide residues allowed in
or on raw agricultural commodities, processed foods, or animal feeds. Establishing
a tolerance is a prerequisite to granting registration for food-use pesticides used in
the United States.

In order to establish a tolerance, EPA must determine whether tolerance levels
proposed by pesticide registrants will present a health risk to the consumer. Reg-
istrants are required to submit toxicology and residue data in their tolerance peti-
tions (applications) to assess possible health and environmental risks, to identify the
nature and amount of residue that could occur with proper pesticide use, and to
present analytical methods that the Food and Drug Administration (FDA) can use
to test the food for residues of the pesticides. EPA scientists (reviewers) use this
data to assess the possible health risks of a pesticide's use on food and to determine
whether proposed tolerance levels would protect the public health. FDA enforces the
EPA tolerances for both domestic and imported produce.

CONGRESSIONAL DEBATE

American consumers can be confident that the United States food supply is safe
from unreasonable risks presented by pesticide residues. The food products available
to U.S. consumers are safe, abundant and economical. NASDA does believe, how-
ever, that improvements in our pesticide laws are needed primarily due to advances
in scientific technological capabilities.

As the national association of the State lead pesticide regulatory agencies and offi-
cials, NASDA believes that S. 1478, the Food Quality Protection Act of 1993, will
improve Federal regulation of pesticide use and establish national uniform toler-
ances for residues in food basea upon a "negligible risk" standard, as recommended
by the National Academy of Sciences (NAS). Adoption of this legislation will allow
the United States to continue to produce the safest, most economical, and most
abundant food supply in the world. NASDA strongly supports passage of S. 1478
and encourages the Senate Agriculture, Nutrition and Forestry Committee to move
quickly to favorably report the bill. S. 1478 is the most balanced and responsible

giece of legislation pending before Congress, and should be the vehicle used by this
ommittee in reauthorizing FIFRA.

The current debate over pesticide regulation reform boils down to a simple conflict
between sound science and emotionalism. Responsible scientists from government,
academia, and the industry have shown in no uncertain terms that pesticides can
be safely used to provide strong benefits to consumers in the form of a safe, abun-
dant and afibrdable food supply. Those who worry that any use of jjesticides is
somehow unsafe — despite overwhelming evidence to the contrary — have been over-
come by the sensationalized emotional falsehoods perpetuated by "so-called" experts
whose existence depends upon creating fear among tne American consumer. These
folks believe that pesticides should be eliminated across the board.

In April, the Clinton administration proposed legislation reforming the way pes-
ticides are regulated. S. 2050 (amendments to FIFRA) and S. 2084 (amendments to
the FFDCA) would implement the administration's plan which unfortunately echoes

125

the beliefs of the "chemophobes" lobby. In those bills, emotion and scare tactics seem
to prevail over sound science.

The focus of S. 2050 and S. 2084 is on eliminating the use of pesticides rather
than on ensuring their safe use. Some of the proposals put forward by the adminis-
tration may sound sensible, but most are unworkably rigid and would provide real
problems for farmers and food producers. Most importantly, they are ultimately con-

exist
Adopt

tant, safe crop protection tools to farmers, coupled with an increase in food prices
and a decrease in availability and quality of fooa.

The most disturbing situation that has been created by the administration's bills
is the likely scenario that no pesticide regulation reform will be passed in this Con-
gress. The 103d Congress needs to pass pesticide legislation. The industry faces
problems created by the conflicting and confusing regulations of FIFRA and the
FFDCA, and consumers need to have their confidence in the food supply reassured.
Both of these objectives can only be achieved by passage of a bill which improves
the situation; one which allows producers to enhance the quality and availability of
a safe and nutritious food supply. S. 1478 accomplishes that; S. 2050 and S. 2084
do not.

RIGID NEGUGIBLE RISK STANDARD

NASDA is specifically concerned that a negligible risk standard not be defined by
reference to a specific acceptable numerical risk level, either in statutory language
or legislative history. It is essential that EPA maintain flexibility to take account
of evolving scientific standards and to consider all relevant safety and exposure in-
formation. S. 1478 allows EPA to employ its expert judgment unhindered by a nu-
rnprncfll str&iffrit 13. elect

While S. 331 (the Pesticide Food Safety Act of 1993 introduced by Senator Edward
Kennedy) eliminates the Delaney clause, it replaces Delaney with a so-called bright-
line standard which would prohibit EPA from setting a tolerance under any cir-
cumstances for a pesticide posing more than a one in one million lifetime cancer risk
based on conservative risk assessment methods. This inflexible standard would un-
reasonably restrict EPA's expert iudgment and would preclude consideration of ad-
vances in toxicological science and risk assessment.

The administration's proposal does eliminate the Delaney clause and replaces it
with a narrative negligiole risk standard. It, however, creates a dual tolerance sys-
tem— one tolerance at the farm gate, and the potential for a second tolerance at the
supermarket. This new, undefined two-tolerance system does not meet the objective
of one safety standard for all foods, and, in fact, will cause increased confusion for
consumers as well as regulatory problems.

LIMITATION OF BENEFITS

S. 1478 would make clear that EPA may establish a tolerance for a pesticide resi-
due posing greater than a negligible risk if EPA determines that there are counter-
vailing benefits. EPA would he directed to take into account health, nutritional and
consumer benefits, including the impact of the loss of a pesticide on the availability
of an adequate, wholesome and economical food supply. EPA would be precluded
from considering any impact on pesticide manufacturers or distributors. NASDA be-
lieves this language must be included in any pesticide reform legislation.

The administration proposal would greatly limit the types of benefits that could
be considered in pesticide tolerance decisions, would prohibit the continuation of a
tolerance based on exceptional benefits beyond 5 years, and would prohibit any con-
sideration of benefits in tolerance decisions after 10 years. The proposal would pro-
hibit EPA from taking into account the value of a pesticide in maintaining an ade-
quate, wholesome and economical food supply unless it could be proven that loss of
the pesticide would cause a "significant disruption in the food supply" and would
have a profound effect on consumer prices. This limited benefits consideration will
expire after the 10-year period. NASDA strongly opposes this narrow benefits stand-
ard which would be virtually impossible to satisfy. Prohibition of consideration of
benefits for pesticide tolerances would deprive growers of pesticides for which there
are no alternatives, would undermine the nutritional welfare of consumers and
would not achieve a meaningful risk reduction.

LIMITATION ON USE OF REALISTIC EXPOSURE DATA

NASDA supports the administration's stated goal of using the best available expo-
sure information, including actual pesticide use and residue data, in setting pes-

126

ticide tolerances. However, the administration's proposal would prohibit the use of
actual exposure information (including pesticide use and residue data) and would
require use of worse case assumptions unless the registrant could satisfy a heavy
burden of proof. Tolerances based on actual exposure data would be subject to dis-
cretionary periodic reconsideration and a possible requirement for separate toler-
ances for raw commodities and processed food. NASDA believes these evidentiary
and procedural hurdles would compel the use of exaggerated exposure assumptions
and inflated risk estimates in virtually all tolerance determinations.

ACCELERATED TOLERANCE RENEWAL

The administration proposal would generally provide for renewal of pesticide tol-
erances over a 7-year period in conjunction with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) reregistration. Special expedited renewal, over a 4-
year period, would be required for pesticides identified by EPA as having a high risk
potential. NASDA believes this accelerated review provision is impractical, could
conflict with the FIFRA reregistration process and would give EPA excessive discre-
tion to eliminate valuable food use pesticides without the procedural protections of
the FIFRA cancellation process.

"PHASE-OUT/PHASE-DOWN OF PESTICIDE REGISTRATIONS

NASDA believes it is unnecessary to give EPA entirely new authority to phase-
out/phase-down the use of a pesticide where "credible scientific evidence shows a
pesticide is reasonably likely to pose a significant risk to humans or the environ-
ment." NASDA believes such authority would encourage EPA to circumvent the
FIFRA cancellation process. It would empower EPA to limit or prohibit the use of
a pesticide without the external scientific review and procedural protections in the
cancellation process, without any consideration of the pesticide's benefits and on the
basis of toxicological evidence that is too weak, incomplete or inconsistent to support
a complete risk analysis. Phase-out orders would generate damaging adverse public-
ity, disrupt sales of food products and cause irreparable harm to food producers and
consumers. With the modification proposed to cancellation and suspension by S.
1478 and the administration proposal, this new vaguely defined concept is com-
pletely unnecessary.

CANCELLATION AND SUSPENSION

NASDA believes that statutory changes are necessary to permit EPA to remove
hazardous pesticides from the market with reasonable speed. Both the administra-
tion proposal and S. 1478 would eliminate the adjudicatory hearing process for can-
cellation procedures, and suspension actions would be decoupled from cancellation
procedures. Accordingly, we strongly support these provisions to streamline and
speed-up the suspension and cancellation procedures. NASDA believes a provision
should be included which would provide an expedited process to retrieve chemicals
from the end-user (farmer) which have been canceled and suspended.

REREGICTRATION PROCESS

The administration proposal calls for a reregistration of all products every 12
years. NASDA supports a reregistration program for all pesticides in order to main-
tain current and accurate data on products. EPA should be required to provide ade-
quate lead time for the submission of any new data requirements. Additionally, the
reregistration process should be made less costly and time consuming, allowing the
Agency to achieve reregistration is a more efficient manner.

TOLERANCE UNIFORMITY & FEDERAL PREEMPTION

A tolerance uniformity provision is indispensable to preserve EPA's leadership in
pesticide regulation and to avoid the consumer confusion and unreasonable burdens
on interstate commerce caused by special State tolerance requirements. NASDA
strongly supports the uniformity provisions of S. 1478.

Pesticide use regulations are best enacted and coordinated at the State level or
higher. In this way, conflicting and overlapping regulations may be avoided, and
greater access to scientific expertise and input is available. With greater citizen
input at the State level, action taken will benefit all residents of the State rather
than one isolated town or village. NASDA supports sensible, uniform Federal/State
regulation of pesticides through passage of preemptive legislation, while allowing
local input into the Federal/State regulatory process.

127

FDA ENFORCEMENT AUTHORITY

FDA already possesses ample enforcement power with respect to food violations,
including seizure, injunction and broad criminal penalty authority. NASDA does not
believe there is a demonstrated need for FDA to have the additional enforcement
authority called for in the administration's proposal, such as recall, embargo and
civil penalty authority for pesticide tolerance violations. This would give FDA exces-
sive discretionary authority without protecting the due process rights of regulated
parties. There is also no reason for FDA to have different enforcement authority for
pesticide tolerance violations than for other food infractions.

PRIVATE RIGHT OF ACTION

NASDA strongly opposes the concept of citizen suits against EPA, State regu-
latory agencies and commercial applicators for any violation of FIFRA as provided
for in the administration's proposal. Such a provision is wholly unnecessary and
only encourages frivolous lawsuits and disrupts agricultural production. There is no
evidence that EPA is unable to adequately enforce FIFRA or that a private right
of action provision would meaningfully enhance pesticide safety.

PESTICIDE RECORDKEEPING

NASDA strongly opposes expansion of the 1990 Farm bill recordkeeping reouire-
ments to cover all farmers who apply any general use pesticides as provided for in
the administration's proposal. Claims that such a requirement is necessary because
USDA does not have sufficient data only points to the failure of data collection, not
the failure of farmers to keep records.

As regulators of pesticide application and pesticide recordkeeping, NASDA's mem-
bers believe such a provision would be absolutely impossible to enforce since those
who apply general use pesticides — categorized as such because of their
nonthreatening environmental nature-do not have to, in any way, be identified.

REDUCED USE

The administration proposal calls for a joint EPA-USDA chaired effort to, within
1 year, develop commodity-specific pesticide use reduction goals. Under the pro-
posal, the statute would clearly state a policy goal "favoring reduced use and direct
Federal agencies to take a leadership role in promoting use reduction and IPM [In-
tegrated Pest Management] in their programs." The plan calls for implementation
of IPM practices on 75 percent of all production land.

While NASDA believes that IPM programs need to be encouraged, the administra-
tion uses the terms "IPM," "reduced use," and "sustainable" interchangeably. IPM
programs do not necessarily mean reduced use, but more efiicient and effective use
of crop protection chemicals. Any legislative goals must clearly define EPM and rec-
ognize tne difference in the three terms.

NASDA supports the administration proposal calling for the elimination of the
prohibition on reauiring EPM training as part of the certification and training pro-
grams. NASDA also looks favorably on the concept of "prescription use" of certain
pesticides in an IPM program only as an alternative to complete loss of the pes-
ticide. Such authority allows the retention of pesticides which may otherwise be can-
celed, and should not become yet another mechanism to reduce production tool op-
tions. This administration request for "prescription use" further points out the need
to allow benefits consideration when registering pesticides.

MINOR USE

NASDA strongly supports the minor use provisions contained in S. 985 and be-
lieves this legislation will go a long way toward correcting the problem created inad-
vertently by the 1988 amendments to FIFRA which have led to the loss of necessary
minor use crop protection chemicals. While the minor use issue is an economic one
and not a food safety issue, it is extremely important to resolve the issue. The ad-
ministration proposal includes aspects of the minor use provisions contained in S.
985, but it is incomplete and lacks the specificity of S. 985. NASDA, therefore, rec-
ommends that the language of S. 985 be used in place of the administration's pro-
posal. If a comprehensive Dill cannot be worked out, NASDA suggests that S. 985
be passed as a stand-alone bill.

STREAMUNE LABEL CHANGES

NASDA believes the administration's proposal calling for an annual uniform label-
ing effective date allowing registrants to make label changes in a predictable, or-

128

derly fashion, would dramatically speed and simplify the process for making
changes.

EXPORT OF PESTICIDES

The administration's proposal would ban the export of any pesticide that has been
canceled in the United States based on health concerns or environmental reasons.
NASDA supports a Isan on exports for any pesticide canceled for health based rea-
sons. NASDA believes this broader prohibition is unnecessary and opposes such a
provision. The United States does not allow food products to be shipped into the
United States unless there is a food tolerance, eliminating concerns about
nonregistered products used in a foreign country and then imported to the United
States. It is further inappropriate for a developed country, such as the United States
to mandate its environmental agenda on developing countries whose major produc-
tion goal may well be feeding its people.

The National Cotton Council of America

The National Cotton Council appreciates the opportunity to present testimony to
the Subcommittee on Agricultural Research, Conservation, Forestry and General
Legislation regarding food safety issues and the administration's pesticide reform
proposal.

TTie National Cotton Council is the central organization of the U.S. cotton indus-
try. Membership includes producers, ginners, warehousers, merchants, oilseed
crushers, cooperatives and textile manufacturers. Most of the industry concentrates
in 17 cotton-producing States, reaching from Virginia to California. The downstream
manufacture of cotton apparel and home furnishings and of cottonseed products,
however, occurs throughout the Nation.

While cotton's annual farm gate value is a significant $5 billion, perhaps a more
meaningful measure of the industry's value to the U.S. economy is its retail impact.
The business revenue generated annually by cotton and its products exceeds $50 bil-
lion. Cotton stands above all other field crops in its creation of jobs and its contribu-
tion to the U.S. economy. The industry, its suppliers and the manufacturers of cot-
ton and cottonseed products, account for 1 of every 13 jobs in the workforce.

The Council conmiends the administration for its hard work in developing pes-
ticide reform legislation. The issue of food safety is complex and any attempt to
change the present law will have far reaching consequences, especially in the area
of risk benefit analysis. We have concerns about many of the provisions in the ad-
ministration's bill and therefore cannot support it.

Our concerns about the administration's proposal include provisions which ad-
dress: (1) The way pesticide safety standards are set — ^the Administrations's bill
would impose an unrealistic conservative and all too rigid safety standard for pes-
ticide tolerances. (2) The methods of assessing products already on the market —
phase-out orders could empower EPA to limit or prohibit the use of pesticides with-
out the external scientific review and procedural protection guaranteed under the
cancellation process, and without any consideration for the pesticide's benefits. (3)
Requirements for multiple tolerances — ^EPA would be authorized to set unnecessary
multiple tolerances for a pesticide on a single food at different points in the distribu-
tion chain. (4) Expanded recordkeeping requirements — EPA would also have the au-
thority to add more requirements to the present recordkeeping program and inspec-
tion procedures on pesticide user premises. (5) Enforcement pohcies — FDA is grant-
ed broad new enforcement power, including recall, embargo and civil penalty au-
thority with respect to pesticide tolerance violation. And most importantly, (6) provi-
sions relating to consideration of risks and benefits — "health benefits" would not in-
clude benefits from an adequate, wholesome or economical food supply.

Addressing risk and preserving benefits are essential components to any credible
food safety law or regulation. The administration's proposal limits and eventually
eliminates benefit considerations for tolerances and a rigid negligible risk standard
for tolerances is established. This is of great concern to our organization.

The American consumer has access to the most abundant, nutritious and aflbrd-
able supply of food and fiber in the world. The benefits derived from this food and
fiber supply are essential to a healthy diet and the health of our economy. The con-
tribution that farmers make to feeding and clothing our Nation as well as others
in the world is significant. Most farmers use only inputs that are necessary to
produce the crop, and new techniques have been introduced in all areas of crop pro-
duction.

129

However, American consumers seem to be increasingly concerned about the safety
of their food. Part of this concern may be explained by distance and dependence.
As the farm population shrinks to about 2 percent and more and more of our citi-
zens depend on others to grow and prepare their food, their understanding of farm-
ing practices and food production has decreased. This may result in a decrease of
confidence in the safety of our food supply.

To some extent, this has been exploited and scare tactics have been employed
whereby the public becomes confusecl and misinformed about important issues. For
example, we are all familiar with the controversies associated with Alar on apples
and the use of irradiation in food processing.

Agricultural production has undergone a radical transformation in the last 30
years, especially in the area of cotton production. For example, field preparation
practices reflect the varied environments and production Systems encountered
across the U.S. growing regions. Conservation tillage Systems are gaining in popu-
larity in areas subject to soil erosion. Conservation tillage, which includes, minimum
till, no till and other forms of maintaining residue on the soil surface, has enabled
farmers to increase their production options in response to their specific challenges.
These systems became feasible with the advent of specialized equipment and new
herbicide chemistry that reduce or eliminate the need for extensive tillage.

Integrated Pest Management is practiced throughout the U.S. cotton belt. This
approach optimizes the total pest management system by utilizing all available
tools, including rotation, crop residue destruction, maximum crop competitiveness,
earliness, pest scouting, action thresholds and high selective crop protection chem-
istry. New chemicals coupled with good IPM schemes are helping to reduce grower
reliance on prophylactic, protective treatments in favor of responsive, as-needed
treatments. Insect management continues to evolve as selective chemistry and Bt
transgenic cottons reach commercialization.

Also, cotton fertilization practices have undergone dramatic changes in recent
years. Supplying nutrients as the crop demands has replaced traditional methods,
as soil and tissue testing have become widespread.

The Council supports S. 1478 a bill introduced by Senators Pryor and Lugar. We
believe that the provisions in this bill give regulators the flexibility that they need
to apply the latest scientific data and technology to pesticide standards. The
Delaney paradox is addressed by establishing a single, flexible negligible risk stand-
ard for pesticides residues in raw commodities and processed food. National uni-
formity is provided for setting tolerances and the pesticide cancellation and registra-
tion process is streamlined. However, what is most important is that benefits are
considered when weighing risks.

Provisions in this bill allow EPA to consider benefits in setting tolerances for pes-
ticide residues on raw commodities and would extend that power to tolerances for
pesticide residues on processed food. EPA would be directed to take into account
nealth, nutritional and consumer benefits, including the impact of loss of a pesticide
on the availability of an adequate, wholesome and economical domestic food supply.

The importance of these benefits should not be underestimated. All American con-
sumers should be able to purchase food that is safe, nourishing, and affordable. Fur-
thermore, a realistic assessment of risks and benefits should be part of all food pol-
icy.

We believe that the provisions in S. 1478 support these goals and we urge Con-
gress to act on this legislation and its companion bill, H.R. 1627, introduced by Rep-
resentatives Lehman, Bliley, and Rowland in the House of Representatives.

SENATOR HELMS' QUESTIONS FOR DR. KESSLER
WITH RESPONSES THERETO

REGULATION OF BRANDS

Reference. Dr. Kessler, on February 25, 1994, you said that if the Food and Drug
Administration (FDA) asserts jurisdiction over tobacco as a "drug," the FDA might
ban brands that smokers are currently smoking; but because you recognize the up-
heaval that would cause, you would also consider a so-called weaning period.

I doubt the American people would stand for such a heavy-handed action on the
part of the Federal Government. Certainly this Senator will not.

That said, this preposterous statement raises some questions:

Question 1. Who will enforce this "weaning" period — do you envision some sort
of Federal police force?

130

Question 2. Would the Federal Government inform the many Americans who
smoke how long before they must quit smoking specific brands, allowing for no vari-
ation among individuals?

Question 3. If your claim that many smokers are addicted to tobacco is correct,
would the FDA have a prolonged weaning period for these addicted smokers, and
if so, for how long will the "weaning" period be extended?

Question 4. After the weaning period during which smokers are to abandon the
brands you select is concluded, how will the Federal Gk>vemment enforce compli-
ance, and do you envision searches of smokers homes to be one of the methods of
enforcing compliance?

Question 5. Is it fair to assume that those who continue to smoke brands which
you decide to ban would be engaging in illegal activity, and if so, what penalty do
you envision?

Question 6. Given the physical harm that other substances cause — including al-
cohol— has the FDA ever considered conducting an investigation similar to the one
conducted on tobacco for alcohol, and if not, why not?

Response. The FDA is actively considering whether tobacco products containing
nicotine, an addictive substance, are subject to the requirements of the Federal
Food, Drug, and Cosmetic Act. This undertaking is of paramount public importance
in part because more than 40 million Americans use tobacco products and tobacco
use is considered to be the single leading cause of preventable death in the United
States. It results in more than 400,000 deaths, and considerably more severe dis-
ability each year.

The Agency is engaged in the investigation of nicotine-containing tobacco prod-
ucts, and is evaluating all responsible actions that might be effective in reducing
new addiction to nicotine, which today almost always occurs during childhood, while
at the same time humanely addressing the needs of the 40-50 million people cur-
rently using tobacco products. As you may know, research has revealed that the
overwhelming majority of these individuals desire to quit but cannot because of nic-
otine addiction.

At present, the Agency has made no decision with regard to asserting its jurisdic-
tion nor what courses of action might be appropriate if Jurisdiction is asserted. Your
first set of questions specifically focuses on the idea of gradually reducing nicotine
in cigarettes. That is certainly an interesting idea. We are enclosing a recent article
that appeared in the New England Journal of Medicine on the subject that you may
find useful. Because FDA has not determined that this is the course of action that
we will pursue, it is not possible for us to provide you details of how such a policy
might be implemented.

Regardless of the course of action FDA pursues, the Agency would not take en-
forcement action against consumers as you suggest in questions 1-5. In regulating
drugs, the Agency places responsibility for accurate labeling and responsible mar-
keting on drug manufacturers, not on consumers.

On August 1-3, FDA's Drug Abuse Advisory Committee met to consider questions
relating to nicotine and addiction and reaffirmed the conclusions of the 1988 Sur-
geon General's Report that cigarettes and other forms of tobacco are addicting, and
that nicotine is the drug in tobacco that causes addiction. They also agreed that
there is probably a daily dose of nicotine from cigarettes and other tobacco products
below which addiction is very unlikely, but could not identify what that dose is.
Their deliberations might also be of interest to you.

In regard to question 6, unlike tobacco, all alcohol-containing products intended
for human consumption are already subject to FDA safety regulation.

TOBACCO PROCESSING

Reference. On March 25, 1994, before a House subcommittee, you appeared sur-
prised that a cigarette isn't simply a tobacco leaf rolled into paper. What is well-
known to anyone even remotely familiar with the business is that cigarette manu-
facturers use a variety of processes in producing their products, very much like
other commercial products.

Question 7. Would you have preferred that the companies had not used such
processes, and instead, had offered the consumer their version of a good, old "roll
your own" cigarette?

Question 8. Are you aware that the manufacturing processes you refer to as
"manipulation" have-according to the Federal Trade Commission — resulted in a
sharp decline in tar and nicotine levels over the last 40 years?

Question 9. Are you inferring that smokers are better served by smoking "roll
your own" cigarettes or any other methodology than the brands on the market

131

today, including the low-yield ones, and if so, wouldn't this be even more of a public
health risk?

Response. Our inquiry is focused on the evidence that cigarette companies may
be using a variety of manufacturing processes to manipulate and control nicotine
levels so that many people buy cigarettes to satisfy their nicotine addiction. This
issue is critical to the central question of whether nicotine-containing cigarettes and
other tobacco products should be subject to the requirements of the Federal Food,
Drug, and Cosmetic Act.

In regard to the level of nicotine in cigarettes today compared to 40 years ago,
the critical issue is not whether it has gone up or down, but rather whether the
level set is sufficient to satisfy an addiction on the part of smokers. Virtually aU
of the cigarettes sold in the United States today contain a level of nicotine well in
excess ofwhat is needed to sustain addiction. Smokers interested in quitting smok-
ing or seeking to reduce the harm caused by cigarettes will be better served only
when they have the freedom to choose whether or not to smoke. As most smokers
themselves testify, when you get hooked as a child, as virtually all smokers do, not
much choice is left.

MANIPULATION IN OTHER INDUSTRIES

Reference. Dr. Kessler, you've created a "buzz-word" term in your fight against
tobacco called "manipulation." Except, you seem to apply it only to a means of pro-
ducing products that you don't particularly like — specifically tobacco products.

Question 10. What are the short term and long term effects of alcohol consump-
tion?

Response. The health effects, including risks and even possible benefits, of regu-
lar, low-dose exposure to alcohol is an issue of ongoing discussion in the medical
community.

Heavy and chronic drinking, however, can harm virtually every organ and system
in the body. As the primary site for alcohol metabolism, however, tne liver is par-
ticularly vulnerable to the harmful effects of excessive alcohol consumption. The in-
iurious effects of alcohol on the liver can lead to the development of fatty liver, alco-
lolic hepatitis and fibrosis, and cirrhosis.

Excessive alcohol use can also have harmful effects on the cardiovascular system.
Heavy drinking may be associated with hypertension, weakened heart muscle, and
increased risk of hemorrhagic stroke and arrhythmias.

Chronic alcohol abuse appears to adversely affect the immune system. Research
suggests that alcohol depresses immune function, thus placing heavy drinkers at in-
creased risk for infectious diseases.

Numerous studies have found that alcohol may have deleterious effects on the en-
docrine system and reproductive function. In men, alcohol can suppress testosterone
levels, among other enects. In women, chronic alcohol use is associated with men-
strual cycle msturbances.

Acute and chronic drinking may have multiple neurologic effects. Neurological
consequences of alcohol exposure include acute alcohol intoxication, alcohol with-
drawal, and nutritional diseases of the nervous system secondary to alcoholism.

For additional information you may consult with the National Institute on Alcohol
Abuse and Alcoholism or refer to the Eighth Special Report to the U.S. Congress
on Alcohol and Health from the Secretary of Health and Human Services or the
13th Edition of Public Health and Preventive Medicine, Chapter 43, Alcohol-related
Health Problems.

Question 11. Inasmuch as manufacturers of some alcoholic beverages and prod-
ucts vary the alcoholic content of their products — alcohol-fortified wines being one
example — are these manufacturers "manipulating" their product?

Response. Beverage alcohol is subject to intensive Federal, State, and local con-
trols intended to reduce the risk alcohol poses to vulnerable individuals. There are
many products and beverages, containing varying amounts of alcohol, in three major
categories: wines, distilled spirits, and malt beverages. The alcohol content difTers
widely for products within each category depending on the various fermentation and
distillation processes used, including, among other things, the substances being fer-
mented (sugars, fruits, grains, or any of their parts or products) and storage condi-
tions {charred vs. uncharred and new vs. used oak containers for distilled spirits).
There are many combinations or formulas used in fermenting and distillation, and
each produces a unique product of varying alcohol content and whose identity is de-
fined in Title 27 of the Code of Federal Regulations (C.F.R.). The regulations do not
identify a class or type of wine as "alcohol-fortified;" however, they do identify aperi-
tif and blended wines which contain added brandy or alcohol. The acceptable ranges

132

of alcohol content for these products are stated in the C.F.R. The level of alcohol
in beverage products is strictly regulated to protect the public.

Directive. Please list all alcoholic beverages and products, the contents of which
are "manipulated" by the manufacturer.

Response. The products and beverages containing alcohol are too numerous to
list. Alcohol is present in many drugs and beverages. With respect to beverages,
within the major categories, there are nine classes of wines and 12 classes of dis-
tilled spirits. Within each class there are different types of beverages that have
varying alcohol contents. There are hundreds of different alcoholic beverages, all
currently subject to Federal oversight and safety regulation.

Question 12. What are the short term and long term effects of caffeine consump-
tion?

Response. The most notable effects after intermediate doses of caffeine (100-250
mg) are increased alertness, energy, and ability to concentrate. Higher doses may
induce anxiety, restlessness, insomnia, and tachycardia. Sleep disturbance has also
been described.

Physical dependence on caffeine has been reported. The abstinence sjnmptoms
most frequently associated with caffeine withdrawal are headache, fatigue or leth-
argy, and anxiety. These can vary in intensity from mild to severe. Studies estimate
that 5-10 percent of caffeine users suffer adverse effects or exhibit withdrawal
symptoms.

Long-term effects of coffee or caffeine have been difficult to substantiate, and ini-
tial trials showing coffee's association with coronary disease and myocardial infarc-
tion, as well as other potentially negative outcomes, have been inconclusive.

Question 13. Inasmuch as caffeine is not a naturally occurring component of
cola, are manufacturers of soft drinks containing caffeine "manipulating" their prod-
uct?

Response. The FDA placed caffeine and hundreds of other substances on the
"generally recognized as safe" (GRAS) list in 1961. Over the years, the Agency has
reassessed the GRAS list and commissioned a committee to investigate these sub-
stances. Currently, caffeine is recognized as safe when used in cola-type beverages
in accordance with good manufacturing practices and does not exceed .02 percent
by weight (21 C.F.R. 182.1180). It is well established that a caffeinated beverage
would be deemed adulterated if the quantity of caffeine added created a reasonable
possibility that the beverage was "injurious." Products containing high levels of caf-
feine, or parenteral forms of caffeine, are regulated as drugs.

Directive. Please list all products containing caffeine, the contents of which are
manipulated" by the manufacturer.

Response. Caffeine can be found in a variety of products including coffee, tea,
cocoa, soft drinks, and chocolate. It is also an ingredient in a number ofprescription
drugs and hundreds of over-the-counter drug products, including analgesics, stimu-
lants, diet preparations, and cold products. Drug products which contain caffeine are
labeled in accordance with FDA monographs and/or regulations (21 C.F.R Parts 300
ff.). The amounts of caffeine contained in over-the-counter products are listed on the
product label. Information on the amount of caffeine contained in prescription drugs
can be obtained from the dispensing pharmacy, the package insert, or any number
or pharmaceutical references, such as the Physician's Desk Reference or the Amer-
ican Drug Index. In all such products, the maximum level of caffeine has been regu-
lated to protect the public.

INCOMPLETE PUBLIC STATEMENTS

Reference. During your testimony before a House subcommittee on June 21,
1994, you stated that you were not there to judge what's right or what's wrong or
characterize any statements.

In your testimony, you stated: "A major American tobacco company spent more
than a decade quietly developing a tobacco plant with exceptionally high nicotine
levels, growing it in Central and South America, and ultimately using it in Amer-
ican cigarettes."

Question 14. Why did you omit from your testimony the fact that the brands
containing this particular type of tobacco included essentially the same nicotine
level as the products they replaced?

Also in your testimony beiore the House subcommittee, you stated, "Many people
have wondered why the cigarette industry would add ammonia compounds to to-

133

bacco products. . . Our investigation has revealed another important use: to affect
the delivery of nicotine to the smoker."

The tobacco companies have since then issued press releases saying that ammonia
compounds in cigarettes do not alter the amount of nicotine the smoker inhales.

Who is right, you or the tobacco companies?

Response. Our June 21, 1994, testimony concerning Brown & Williamson's dec-
ade-long interest in the high-nicotine "Y-1 ' variety of tobacco emphasized that the
company and its contractors possessed both the technical capability and the willing-
ness to develop tobacco plants with higher than normal levels of nicotine. In this
particular case, the specially bred Y-1 plant contained approximately twice the level
of nicotine naturally found in similar commercially sold varieties of tobacco.

The patent for the Y-1 tobacco variety stated, in fact, that, 'The nicotine content
of the leaf of this variety is usually higher than 6 percent by weight . . . which
is significantly higher than any normal variety of tobacco grown commercially. "
Moreover, Brown & Williamson characterized its achievement in a patent filing by
describing the Y-1 variety as providing a "pleasant taste and aroma when included
in smoking tobacco products, yet it is possessed of the N. rustica high nicotine at-
tribute. So far as we know, this has not been accomplished before ..."

Previously, when we inquired whether plants were bred specifically for higher nic-
otine content, we were told that this was not feasible. Brown & Williamson officials
told us that their firm did no plant breeding research or development, according to
the sworn statements of four FDA ofTicials present at a visit to the company's
Macon, Georgia, facilities on May 3, 1994.

These facts buttress one of the central points first made in our March 25, 1994,
testimony before Congress: That tobacco companies may be controlling smokers'
choice by controlling the levels of nicotine in their products in a manner that creates
and sustains an addiction in the vast majority of smokers. Previously, Brown &
Williamson and other tobacco companies insisted that "nicotine follows tar" in ciga-
rettes, meaning that tar and nicotine levels are not set independently. The signifi-
cance of the development of the Y-1 plant was that it enabled Brown & Williamson
to maintain the level of nicotine in cigarettes while reducing tar.

As we revealed in our June 21, 1994, testimony before Chairman Waxman's sub-
committee, a major cigarette manufacturer's 1991 handbook states that adding cer-
tain ammonia compounds alters "the ratio of extractable nicotine to bound nicotine
in the smoke ... in favor of extractable nicotine. As we know, extractable nicotine
contributes to impact in cigarette smoke and this is how ammonia can act as an
impact booster." The handoook indicates that this ammonia technology enables
more nicotine to be delivered to the smoker than if the ammonia technology is not
employed.

In his testimony before Chairman Waxman's subcommittee on June 23, 1994,
Brown & Williamson Chairman Thomas E. Sandefur, Jr., testified in response to a
Question from a subcommittee Member that "it is my understanding that ammonia
Qoes have the ability to provide for free nicotine ..." In addition, Mr. Sandefur
testified that "a number of tobacco manufacturers . . . use ammonia."

TAR AND NICOTINE MEASUREMENTS

Reference. The tar and nicotine yields found in cigarettes are based on meth-
odology developed by the Federal Government, not the tobacco industry. In fact, the
Federal Trade Commission measured the levels of tar and nicotine itself

Yet, the FTC closed its laboratory doors because they couldn't justify the cost of
these reports since their results almost always replicated that of the Tobacco Insti-
tute Testing Laboratory. The FTC does, however, oversee the levels that are re-
ported by tne industry and has the authority to verify them or bring an action
against the industry for deceptive advertising practice.

Question 15. When you claim that smokers of low-yield brands of cigarettes do
not receive lower levels of nicotine, are you implying that the FTC, as well as the
tobacco industry, are deceiving smokers into thinking they are getting lower nicotine
levels?

Response. Beginning in 1983, the FTC became aware of questions about the
industry-developed methodology for measuring tar and nicotine yields in cigarettes,
the so-called FTC numbers. As cigarette manufacturers themselves noted in the
matter of Barclay cigarettes, there was reason to question how meaningful these
numbers were. Experts within FTC and elsewhere concluded that these measure-
ments did not refiect actual human intake, and thus had the potential to be mis-
leading.

Recently, the FTC formally raised the issue of the actual utility of the method in
a letter to National Cancer Institute (NCI) Director, Samuel Broder, M.D. The FTC

134

letter 9 article noted broad concern as to whether yield determinations by the FTC
method mislead consumers as to relative risk of smoking cigarettes of varying
yields, and requested that NCI convene a formal consensus conference to evaluate
the utility of FTC's current method and make recommendations based on that eval-
uation.

It is FDA's understanding that NCI has decided to sponsor such a conference in
the fall. We will briefly summarize the basis for the concerns of FDA, FTC, and oth-
ers with the current FTC method.

In our testimony before the House subcommittee on Health and the Environment
on March 25, 1994, we presented independent scientific data demonstrating that the
automated smoking machine method of testing for cigarette tar and nicotine yields,
currently employed by the Tobacco Institute Testing Laboratory and sanctioned by
FTC, produces yields that do not correlate to yields in actual smokers. Specifically,
the data show a lack of correlation between smoking machine nicotine yield and
blood levels of nicotine in smokers. In our testimony, we discussed several confound-
ing factors identified by researchers (smoker compensation, smoker blocking of ven-
tilation holes, increased rate of cigarette paper bum, and extension of the cigarette
overwrap) that contribute to the lack of correlation of smoking machine yields to
nicotine blood levels. Smoker compensation primarily reflects the extent to which
human smoking behavior differs from the FTC machine. Hov/ever, placement of ven-
tilation holes, cigarette paper bum rate, and overwrap length are confounding fac-
tors that are clearly within the control of cigarette manufacturers.

The statements in our testimony are supported by the following peer-reviewed
journal articles.

— Pillsbury HO, Bright CC, O'Connor KJ, Irish FW. Tar and nicotine in cigarette
smoke. J. Assoc. Offic. Analyt. Chem. 1969;52(3), 458-462.

— Benowitz NL, Hall SM, Heming RI, Jacob P, Jones RT, Osman AL. Smokers
of low yield cigarettes do not consume less nicotine. NEJM 7/21183;309(3): 139-
142.

— Heming RI, Jones RT, Bachman J, Mines AH. Puff volume increases when
low-nicotine cigarettes are smoked. Brit. Med. J., 7/18/8 1;283: 187-189.

— Sutton SR, Russell MA, Iyer R. Feyerabend C, Sallojee Y. Relationship between
cigarette yields, puffing patterns, and smoke intake: evidence for tar compensa-
tion? Brit. Med. J., 8/28/82;285: 600-603.

— Wald NJ, Boreham J, Bailey A. Relative intakes of tar, nicotine, and carbon
monoxide from cigarettes of different yields. Thorax 1984;30:361-364.

— Goldfarb T, Gritz ER, Jarvik ME, Stolerman IP. Reactions to cigarettes as a
function of nicotine and "tar." Clin. Pharmacol. 7her. 19(6):767-772.

— Maron DJ, Fortmann SP. Nicotine yield and measures of cigarette smoke expo-
sure in a large population: are lower-yield cigarettes safer? AJPH 5/
87;77(5):546-549.

— Stepney, R. Consumption of cigarettes of reduced tar and nicotine delivery.
Brit. Addiction. 1980;75:81-88.

— Grunberg NE, Morse DE, Maycock VA, Kozlowski LT. Changes in overwrap
and butt length of American filter cigarettes. An influence on reported tar
yields. N. Y. State J. of Med., 7/85:310-312.

Directive. If a new system of measuring nicotine is needed, please give your spe-
cific recommendations for a more accurate methodology.

Response. Although FDA is aware of methods for assessing tar and nicotine
yield that more closely approximate actual nicotine exposure to smokers, the Agency
is not presently in a position to recommend any one methodology, nor is FDA aware
of a consensus in the scientific community as to any one methodology. In light of
concerns with the accuracy of the current method held by FTC, FDA, the Congress,
and members of the scientific community, and the lack of consensus as to alter-
natives, FDA fully supports NCI's plan to evaluate the accuracy and relevance of
the FTC method in a scientific forum. It is the Agency's position that sound science
should be the cornerstone of any consensus building that would underlie regulatory
decisionmaking on this issue.

135
ESTABLISHING A NICOTINE THRESHOLD FOR ADDICTION

THE IMPLICATIONS FOR TOBACCO REGULATION

On February 25, 1994, the Food and Drug Administration (FDA) released a letter
to the Coalition on Smoking or Health announcing its intention to consider regulat-
ing cigarettes. The Agencj^s premises were that the vast majority of tobacco users
self-administer the product for the drug effects of nicotine and to sustain addiction
and that cigarette manufacturers control the levels of nicotine in cigarettes to main-
tain this addiction. The FDA further raised the possibility of regulating cigarettes
on the basis of their nicotine content to prevent addiction.

On February 28, 1994, the ABC news program Day One presented evidence that
tobacco manufacturers manipulate the nicotine content of cigarettes. One way they
do this is by removing nicotine from tobacco and then adding it back in controlled
amounts, using tobacco extracts containing nicotine. It was suggested on the news
program that the amount of nicotine in tobacco was controlled to ensure that the
level was adequate to maintain nicotine addiction. In support of this idea the pro-
gram quoted an internal memorandum from a Philip Morris Tobacco Company sci-
entist that had been discovered in recent litigation: "The cigarette should be con-
ceived not as a product but as a package. The product is nicotine . . . Smoke is
beyond question the most optimized vehicle of nicotine and the cigarette the most
optimized dispenser of smoke." ^ That the pharmacologic actions of nicotine are im-
portant determinants of why people smoke is supported by studies conducted by the
tobacco industry 2^ and by nonindustry researchers.'*

That nicotine addiction sustains tobacco use for most smokers is well established.*
Once a person is addicted to nicotine, quitting smoking is difficult, and more than
90 percent of the smokers who try to quit each year fail.^ An important, if not the
most important, component of a policy to reduce tobacco use in the population is
to prevent the development of nicotine addiction in young people.® Young people do
not start to smoke because they are addicted, but rather because of psychosocial and
environmental influences, particularly peer influences, psychological factors, and ad-
vertising. Young people generally underestimate the addictiveness of nicotine, and
most of them at first intend to smoke only for a few years.® However, once they
begin to smoke, many become addicted to nicotine, and this addiction sustains the
self-injurious behavior into adulthood. The result of nicotine addiction is a 40 per-
cent probability of premature death from illness caused by tobacco.'^ It is difficult
to prevent adolescents from experimenting with cigarettes. However, by regulating
the availability of nicotine in tobacco products, it may be possible to prevent the
transition from experimental or occasional smoking to addiction. This paper exam-
ines the proposition that the level of nicotine likely to produce addiction can be esti-
mated and tnat mandating a nicotine content below that level is a feasible approach
to tobacco regulation.

IS THERE A THRESHOLD LEVEL OF NICOTINE INTAKE ASSOCIATION

WITH ADDICTION?

We define addiction according to the Surgeon General's 1988 Report on Nicotine
Addiction: it is the compulsive use of a drug that has psychoactivity and that may
be associated with tolerance and physical dependence (i.e., may be associated with
withdrawal symptoms after the cessation of drug use).'* For smokers, addiction is
assumed to involve daily smoking of cigarettes, difficulty in not smoking every day,
and a high likelihood of withdrawal symptoms afler cessation of smoking.

Most Americans smokers are believed to be addicted according to these criteria.^
However, approximately 10 percent of current smokers (a group sometimes called
tobacco "chippers") regularly smoke 5 or fewer cigarettes per day and appear not
to be addicted.^ Most do not have withdrawal symptoms when they stop. Typically,
such people smoke in specific situations, can skip smoking for one or more days, and
can quit smoking without great personal distress.

The daily intake of nicotine from tobacco can be estimated from the level of
cotinine, the principal metabolite of nicotine, in blood or saliva. ^° The average blood
cotinine concentration in addicted smokers is about 300 ng per milliliter.^^ ^^ Smok-
ers of 5 or fewer cigarettes per day have average serum cotinine levels of 54 ng per
milliliter and an average consumption of 3.9 cigarettes per day.^^ The cotinine level
normalized for cigarette consumption is 14 ng per milliliter per cigarette, or 70 ng
per milliliter for a person who smokes 5-cigarettes-per-day. Thus, it is reasonable
to estimate a level of 50 to 70 ng of cotinine per milliliter as a cutoff point for the
addictive threshold. Of course, there is no sharply demarcated threshold level and
there are some people who smoke fewer than five cigarettes per day and have great

136

difficulty in quitting and others who can smoke more than five cigarettes per day
and quit with ease.

Studies involving the infusion of nicotine and cotinine into smokers indicate that
the daily intake of nicotine can be estimated as 0.08 times the blood cotinine per
milliliter corresponds to a daily intake of 4 to 6 mg as a threshold level that can
readily establish and sustain addiction.

DELIVERY OF NICOTINE FROM CIGARETTES

On average, an American cigarette contains 8 to 9 mg of nicotine. ^^ The con-
centration oT nicotine in tobacco ranges from 1.5 to 2.5 percent.

Typically, the cigarette delivers about 1 mg of nicotine to the circulation of the
smoker, ^"^ representing an absolute bioavilabiuty of about 12 percent. The variation
in intake per cigarette is considerable, however, ranging from 0.3 to 3.2 mg, rep-
resenting a bioavailability of 3 to 40 percent, depending on how the cigarette is
smoked.^'* ^^ The daily intake of nicotine is poorly correlated with machme-deter-
mined vields.m^ 16 'j^^jg jg because smoking machines smoke cigarettes in a stand-
ardized way, whereas people can take more puffs, pufT more intensively, and occlude
ventilation holes in the filter or on the cigarette in order to obtain the desired dose
of nicotine from most cigarettes. When the number of cigarettes available to an indi-
vidual smoker is reduced from an average of 38 to 5 per day, the intake of nicotine
per cigarette increases an average of threefold,^'^ a figure consistent with the maxi-
mal absolute bioavailability is the percentage of the nicotine contained in the ciga-
rette that can be absorbed systemically by the smoker; it is unrelated to the smok-
ing-machine yield. If the design of cigarettes were to change, bioavailability would
need to be reassessed in people smoking the redesigned cigarettes.

THRESHOLD LEVELS OF NICOTINE IN CIGARETTES AS A WAY
TO AVERT ADDICTION

Although machine-measured cigarette yields are not useful in predicting a smok-
er's intake of nicotine, the absolute level of nicotine in a cigarette could be regulated
to limit the maximal obtainable dose. Studies using cigarettes developed for re-
search purposes to be low in nicotine have demonstrated that intake can be limited
by restricting the amount of nicotine in the tobacco.^ ^^

Assuming that the estimated target daily dose of nicotine should be 5 mg or less
to avert addiction and that a young person may smoke up to 30 cigarettes per day,
one can conclude that a maximal available (i.e., systemic) dose of 0.17 mg of nicotine
per cigarette is the threshold level for a less-addictive cigarette. Assuming a maxi-
mal bioavailability of 40 percent with intensive smoking, an absolute limit of 0.4
to 0.5 mg of nicotine per cigarette should be adequate to prevent or limit the devel-
opment of addiction in most young people. At the same time, it may provide enough
nicotine for taste and sensory stimulation.

A POSSIBLE STRATEGY FOR REGULATION

The rationale behind the strategy for regulating the nicotine content of cigarettes
is to prevent the development of nicotine addiction in young people. To minimize
the hardship to already addicted adult smokers, the level of nicotine in tobacco could
be reduced gradually, with a goal of reaching a target nicotine level over perhaps
10 to 15 years. The intended result of such a strategy would be that cigarettes could
still be sold, but the number of addicted smokers would be markedly reduced. In
the absence of addiction, levels of tobacco consumption should decline sharply, caus-
ing a substantial reduction in the rates of tobacco caused illnesses.

There are, of course, a number of caveats. A threshold-old level for nicotine addic-
tion is a theoretical concept based on observations in current smokers and studies
of the bioavailability of nicotine during smoking restriction. That restricting levels
of nicotine would prevent addiction needs to be verified empirically. There is concern
that for already addicted adult smokers, reducing the nicotine level in tobacco might
result in more intensive compensatory smoking, with increased exposure to toxic
combustion products such as carbon monoxide and tar. Switching from higher-yield
to lower-yield cigarettes has been shown to result in smoking more cigarettes or
smoking more intensively, both of which are associated with increased exposure to
carbon monoxide and other toxins. ^^^^ Overcompensation (i.e., inhaling more smoke
from low-nicotine cigarettes than from higher-yield brands) appears, however, to
persist only for days or weeks. In long-term studies of carbon monoxide exposure
after subjects switched to low-yield cigarettes, compensatory oversmoking appears
not to persist.20 21 it ig also conceivable that cigarettes could be manufactured to re-
duce the delivery of tar and carbon monoxide as well as the nicotine content. Even
if there is some element of overcompensation and smokers are exposed to increased

137

levels of toxins, their short-term (10-year) risk may be offset by the long-term bene-
fit of a greater likelihood that they will stop smoking (as cigarettes become less sat-
isfying) and by the enormous benefit of preventing nicotine addiction in future gen-
erations.

It should be noted that other researchers have proposed the introduction of "safer"
cigarettes that are enriched with nicotine in order to reduce the ratio of tar to nico-
tine.22 jy^Q rationale for such cigarettes is that smokers would need to inhale less
smoke to obtain the desired dose of nicotine, and exposure to toxins would thus be
reduced. A strategy involving nicotine-enriched cigarettes might reduce morbidity
and mortality from cigarette smoking, but the reduction would probably be limited,
because even at reduced doses, tobacco smoke is highly toxic. The goal of that ap-
proach— producing a safer cigarette for those who cannot stop snioking — is the dia-
metric opposite ofours. Our goal is the prevention of nicotine addiction and a reduc-
tion in tne prevalence of cigarette smoking, which in the long term would eliminate
exposure to the toxins in tobacco smoke and reduce tobacco-induced morbidity and
mortality much more.

The measures described in this proposal may seem drastic to some. However, the
problem of one quarter of a billion premature deaths caused by the tobacco use in
developed countries'^ calls for drastic action. Tobacco use is motivated by nicotine
addiction. We offer a strategy for the prevention of nicotine addiction based on re-
cent scientific data. This approach deserves study by the regulatory authorities.

We are intended to Dr. Cnarles R. Schuster, former director of the National Insti-
tute on Drug Abuse and Dr. John Slade, University of Medicine and Dentistry of
New Jersey, Robert Wood Johnson Medical School, for their helpful comments; and
to Ms Kaye Welch for assistance in the preparation of the manuscript.

Address reprint requests to Dr. Benowitz at San Francisco General Hospital,
Bldg. 30, Rm. 3220, 1001 Potrero Ave., San Francisco, CA 94110.

Supported in part by grants (DA02277 and DA01696) from the National Institute
on Drug Abuse.

REFERENCES

1. Dunn, WL., Motives and incentives in cigarette smoking. PlaintifTs exhibit P-
5171. Cipollone v. Liggett. Litigation documents 3.4 TPLR 3.362 (internal
memorandum, Philip Morris Tobacco Company).

2. Robinson, JH, Pritchard WS, Davis RA, Psychopharmacological effects of
smoking a cigarette with typical "tar" and carbon monoxide yields but mini-
mal nicotine. Psychopharmacology (Berl) 1992;108:466-72.

3. Robinson, JH, Pritchard WS, The role of nicotine in tobacco use.
Psychopharmacology (Beri) 1992;108:397-407.

4. Department of Health and Human Services, Public Health Service, The health
consequences of smoking: nicotine addiction: a report of the Surgeon General.
Washington, DC: Government Printing Office, 1988. (DHHS publication no.
(CDC) 88-8406.)

5. Fiore, MC, Trends in cigarette smoking in the United States: the epidemiology
of tobacco use. Med Clin North Am 1992;76:289-303.

6. Department of Health and Human Services, Public Health Service, Preventing
tobacco use among young people: a report of the Surgeon General. Washing-
ton, DC: Government Printing Office, 1994.

7. Peto R, Lopez AD, Boreham J. Thun M, Health C Jr., Mortality from tobacco
in developed countries; indirect estimation from national vital statistics. Lan-
cet 1992;339:1268-78.

8. Henningfield, JE, Clayton R. Pollin W., Involvement of tobacco in alcoholism
and illicit drug use. Br J Addict 1990;85:279-91.

9. Shiffman S., Tobacco "chippers" — individual differences in tobacco dependence.
Psychopharmacology (Berl) 1989;97:539-47.

10. Benowitz, NL, Jacob PL, Metabolism of nicotine to cotinine studied by a dual
stable isotope method. Clin Pharmacol Ther (in press).

11. Benowitz, NL, Hall SM, Heming RI, Jacob P III, Jones RT, Osman A-L.,
Smokers of low-yield cigarettes do not consume less nicotine. N Engel J Med
1983; 309:139-J2.

12. Gori, GB, Lynch CJ., Analytical cigarette yields as predictors of smoke
bioavailability. Regul Toxicol Pharmacol 1985;5:314— 26.

13. Shiffman, S, Fischer LB, Zettler-Segal M, Benowitz NL., Nicotine exposure
among nondependent smokers. Arch Gen Psychiatry 1990;47:333-6.

138

14. Benowitz, NL, Jacob P III, Daily intake of nicotine during cigarette smoking.
Clin Pharmacol Ther 1984;35:499-504.

15. Benowitz, NL, Jacob P III, Denaro C, Jenkins R., Stable isotope studies of nic-
otine kinetics and bioavailability. Clin Pharmacol Ther 1991;49:270-7.

16. Coultas, DB, Stidley CA, Samet JM., Cigarette yields of tar and nicotine and
markers of exposure to tobacco smoke. Am Rev Respir Dis 1993;148:435— 40.

17. Benowitz, NL, Jacob P III, Kozlowski LT, Yu L., Influence of smoking fewer
cigarettes on exposure to tar, nicotine, and carbon monoxide. N Engel J Med
1986;315:1310-3.

18. Benowitz, NL, Jacob P III, Circadian blood nicotine concentrations during cig-
arette smoking. Clin Pharmacol Ther 1982;32:758-64.

19. Stepney, R., Consumption of cigarettes of reduced tar and nicotine delivery. Br
J. Addict 1980;75:81-8.

20. Guyatt, AR, Kirkham AJ. Mariner DC, Baldry AG, Gumming G., Long-term
effects of switching to cigarettes with lower tar and nicotine yields.
Psychopharmacology (Berl) 1989;99:80-6.

21. Russell, MA, Sutton SR, Iyer R, Feyerabend C. Vesey CJ., Long-term switch-
ing to low-tar low-nicotine cigarettes. Br J Addict 1982;77:145— 58.

22. Russell, MA, Low-tar medium-nicotine cigarettes: a new approach to safer
smoking. BMJ 1976;1:1430-3.

LETTERS

National Agricultural Chemicals Association,

Washington, DC, August 4, 1994.

Hon. Thomas A. Daschle,
U.S. Senate, Washington, DC.

Dear Senator Daschle: This letter is in response to my promise at the July 28,
1994 hearing, to provide you with additional information and perspective on the
question of the theoretical maximum residue contribution (TMRC) exceeding EPA's
safety standard (commonly known as the Reference Dose) (RfD).

Research has shown that use of the TMRC (exposure to residues at the tolerance
level on 100 percent of the food for which a tolerance has been established) has been
shown repeatedly to overstate the risk by many orders of magnitude. Also, in most
cases where the TMRC exceeds the RfD, the use of actual or anticipated residues,
combined with percent crop treated, demonstrates no exceedance of the RfD. (Please
see the enclosed Fisher letter for documentation). There are many pesticides where
the TMRC is only a small fraction of the RfD. {See the enclosed Fisher letter and
Table 3 in the Winter article).

Dr. Winter also points out that creating a new tolerance system (as the Clinton
administration has proposed in their legislation) for fresh and processed food at the
retail level will not provide an increase in public health protection over and above
the current system. We agree that our fooa is already safe. Such a scheme would
not make it any safer.

You also asked me to provide you with the definition of negligible risk which we
support. The enclosed language is taken from S. 1478, The Food Safety Act of 1993,
introduced by Senators Pryor and Lugar and cosponsored by 20 additional Senators.

We would be happy to discuss the enclosed material with you and your staff. We
would also be happy to arrange for Dr. Winter to elaborate on his research on food
safety. We also request that this letter and enclosures be entered into the record
of the July 28th hearing.
Sincerely,

Jay J. Vroom.

139

i ^4^^ i UNITED STATES ENVIHONMENTAL PROTECTION AGENCY

% -ik\v2. ° WASHINGTON. D.C. 20460

MW 30 1992

OR=ceof

PESnODeSANOTOXC
SUBSTANCES

Honorable Edward M. Kennedy _ •

Charman

Committee on Labor and Human Resources

United States Senate

Washington, D.C. 20510

Dear Mr. Chairrrian:

Thank you for your letter of February 1Q requesting a Est of all food-use
pesticides comparing tJie TheoretiGal Maximum Residue Contribution (TMRC) to the
Reference Dose (RfD) for all consumer onsufis. Indudif^ children. In responding to
your letter, we believe it is important to put this infcxmation In contexL As we explain
below, simply comparing the TMRC and the RfD can be seriously misleading.
TTierefore, we have tried to stpply not only the infonnation you requested, but also
additional data thai lend perspective to the e>aentaf dietary exposure to pesflddes.

Enclosed is a Kst of ioodnse pestiddes comparing the TMRC to the RfD for the
general population end each of the populaiion subgroups In the ErMronmental
Protection. Agency^ '(EPAIs) Di^ary R^ Evaluafion System (CfRE$) (see Tabfs 1).'
The numbers in this table represent the tfieoretical dietary exposure esfimata as a
percent of the RfD (uq^ TMRC/RfDx100%). Both the TMRC and Effi) are calcUated in
units of milligrams per kilogram of body weight per day. "As you can see, Infants and
children are the two subgroups that typically receiva the most' exposure to pesb'dde
residues in the diet as a percentage of body weight The estimated re^due
contributions for the other subgroups are almost always dose. to the estimates for ttie
general population. ^

A number of pestiddes on the endosed fist have TMRCs which exceed ttieir
RfOs. The Agency uses TMRC/RfD calculations to flag Chemicals wtiich should
receive doser regulatory scrutiny tsecause dietary exposure appears to exceed ■
acceptable levels, but, for several reasons, the Agency does not believe that TMRC
excGodance of an RfD is an indication of actual resk. As has been shown repeatedly,
the TMRC greatly overstates dietary exposure to pestidde residues. In calculating the
TMRC, EPA assumes that the pestidde is present on 100% of each crop for which it
has a tolerance. We also assume that residues on the consumed commodities are at
the tolerance levels. In reaRty, these two assumptions are rarely true. Often, only a
relatively small percentage of crops are treated, and actual pestidde residues on food
at the dinner table are usually much lower than tolerance levels.

Printed on FiecycietJ Paper

140

While we recognize that the TMRC greatly overstates dietary exposure, we think
that there is a use for TMRC calculations. Since a TMRC is dearly an upper Cmit on
exposure and it can be quickly and easily calculated, we use the TTVIRC/RfD
comparison to evaluate whether there is any possible dietary concern. If the TMRC is
below the RfD, we can be certain that actual dietary exposure is far below any level of
concern. In such an instance, determining the actual exposure level would be wasteful
of scarce Agency resourices. On the other hand, If the TMRC exceeds the RfD, some
further considerofion of dietary exposure may be appropriate, as discussed below.

In numerous cases Involving TMRCs which exceed the RfD, EPA has developed
more refined dietary exposure estimates which are based on reliable irrformafion on
levels of resldiies anticipated In food, and which more dosely approadi actual human
exposure to pesticides In the diet Enclosed is a tat>le with reiined percent of RfD
calculations CTable 2) for food-use pestiddes based on evaBable antidpated
residue (AR) data (&g., data on the percentage of crc^ to which the pestidda Is
applied, re^ua monttoring data end field trial data). As you can see, wtien we factor
in these addifional data, we obtain dietary oqjosure estimates that ere 10^ or ItXTs of
times lower than the TMRC. A$ the Agency teceives and reviews addifional residue
data during the reregistrBtion process, we wiH be able to make more reaHstic estimates
of pestidde residue levels In food.

[NOTE: Six pestiddes at the bottom of Tables 1 and 2 do not have accuittte
RfD exceedance numbers for a number of other reasons: EPA has not established
RfDs for fiucythrinate and fsofenphos; the numbers for m^hyl bromide are Inaccurate
' because the TUD Is based on effeots from exposue to methyl bromide, whils the •
tolerances are est^nshed for residues for the bnxr^de ion; and the values forttie
EBDCs (mefiram, maneb and mancozeb) do not reflect the Agencyis recent regulatacy
action to cancel some food uses for these diemfcab.]

Even in the absence of antidpated re^due data, we know that many of tfie
TMRC calculatrans i\ Table 1 overstate actual es^xjsure to pestidde residues In the
diet Several pestiddes on the Tist are no longer registered in the U.S. and are
scheduled to have some or all of their tdenanoes reveled We have endosed a Dst of
those pestiddes wMch have had some or all food use registrations canceled (Table
3a). Also endosed Is a flst of pestiddes whidi are ejq^ected to have some or aD
tderances revoked in 1992 (Table 3b). Although we have Identified these chemicals
for you, we have not yet updated the DRES system to account for many of these
canceled pestidde uses and revoked tolerarxjes. In addition, many of the TMRC and
AR calculations (Tables 1 and 2) indude pestidde uses which have import tolerances .
but no corresponding U.S. registration. For pestiddes with import tolerances, TMRC
calculations do not account for the fact that some Imported commodities may make
up only a small percentage of consumption in the United States. Rnally. in some
cases the TMRC calculations include residue levels from temporary pestidde uses
under emergency exemptions that may no longer be in effect

141

The enclosed information also tends to overstate the dietary risks for pesticides
because of EPA's conservative approach in calculating RfDs. To establish an RfD,
EPA scientists evaluate toMdty data to identify the highest level of exposure which did
not cause any effect in any of the tests. This is called the "No Observed Effect Level,"
or NOEL The Agency then diwdes the NOEL by an uncertainty factor, usually 100, to
calculate the RfD. The uncertainty factor is intended to allow an extra margin of safety
to compensate for (1) the sdentific uncertainty Inherent in the process of extrapolating
potential human responses from animal data, and (2) the possibility of differing
sensitivities to a pesticide in Indiwduals or subgroups (such as children) among the
general population. When EPA has a complete toxicobgy data base on whk^ to base
the RfD, the uncertainty factor reflects a 10-fold margin of safety for each of tfiese two
factors, resulting in a 100-fold margin of safety.

In cases where EPA does rxit have a complete toucity data base, a larger,
provisional uncertainty factor - usuafly 300 or 1,000 - is (ised to cateulate the RfD.
We have Identified the cherrtcals wtK^e RfDs were calculated using a provistonal
uncertainty fector (see Table 4). Th<Me chemicals wftfi Incompleta data bases are
marked with a 'P* ^or Provisional Acceptable Dally Intake or PADQ or an *L* (for
Pno>nslonal Limiting Dose or PLD). It Is the Agenc/s experience that completing a
chemical's toMcity data base usually reduces the exceedarxje. As we receive and
review additional tojddty data In our rereglstration program, we will be-atile to update
the RfDs end the endosed ORES calculations for food-use pestiddes.

EPA's RfD Exceeders Protect . .

While TMRC calctiafions overstate dietary exposure, EPA has used RfD
exceedance based on TMRC calcUations to help detemilne the need for additional
dietary exposure analyses and rsgutetory decisions. Several yeans "ago, EPA
recognized that RfD exceedance posed a coiicem, and we initated'a project to t&ke a'
closer look at some of the highest apparent RfD exceeders. The Agency selected
chemicals that had significant apparent RfD exceedances t>a^ on TMRC
calculations, had fairly complete data bases, had not been canceled, and were not
being examined In another system such as the Special Review process. Using these
criteria, we narrowed the list down to ten pesticides. Using limited available data on
the percent of crops on which tfie pesticides are used and anticipated residues, we
calculated more accurate dietary exposure estimates for these pestiddes. For most of
these new estimates, the calculation reflected a combination of both antidpated
residue values and TMRC values, for those CTops lacking reliable and readily available
data. After conducting these analyses (which, thus, still overstated exposure), seven
out of the ten pestiddes were found not to exceed their RfDs. The RfD exceedances
for two other pestiddes were reduced dramatically, and we expect that additional
residue data will indicate that total dietary exposure estimates for these two pestiddes.
which still exceed their RfDs, will be below their RfDs. For example, the latest
calculations for endosulfan (one of the two chemicals) are based on an assumption

142

that all tea consumed in the United States is imported from India and is treated with
endosutfan (to account for an import tolerance for endosuifan used on dried tea from
India). Even though we know that only some of the tea consumed in the United
States comes from India (and a smaller amount will have been treated with
endosuifan), until we can quantify these factors, we will not revnse our dietary exposure
calculations for endosuifan to reflect these factorB. The import tolerance for tea
contributes heavily (roughly 60%) to the current estimate of dietary exposure to
endosuifan. We are still reviewing additJonal data on the last pesticide in the pilot
project (diazinon). and we expect to complete this analysis soon. More detailed
results of the Agency's analyses to date fty the ten chemicals in the pilot project are In
the table below:

Pesticide

Starting % of RfD Using
TMRC Calculations

% of RfD After Factoring in 1
% Crop Treated and/or |
Anticipated Re^due Data

Dimethoate

6377%

45%

Diuron

518%

27%

Endosutfan

2421%

242%

Fenitnothlon

942%

19%

Malathion .

439%

57%

Methyt ParetWofi

4049%

262%

Naled •

523%

28%

Parathion

636%

30% • •

Profenofos

666%

Diazinon

8304%

incomiplete

While the RfD pilot project does not answer every qiiestion about all RfD
exceeders, it does tell us that more realistic estimates of exposure obtained by using
anticipated residue information generally results in non-exceedance of the RfD.
Therefore, we believe that in most cases our resources would be t>est directed toward
reviewing most RfD exceedance issues during reregistration. EPA expects to receive
much of the data needed to reevaluate tolerances and dietary exposure estimates for
food-use chemicals in the reregistration process.

143

In addition to the exceedance project, EPA uses RfO exceedance based on
TMRC calculations es a basis for regulatory decisions on new food uses. Under the
Registration Standards program (1984-88), when we found chemicals whose TMRCs
greatly exceeded the RfDs, we made decisions not to allow significant new food uses
until we either received more data to show that actual dietary exposure was below the
RfD or the registrant voluntarily canceled other food uses to reduce overall dietary
exposune.-EPA defines a "significant new food use' as any food use that would
Inaease the TMRC by 1% or more. We have enclosed a list of chemicals from the
Registration Standards progrcim where EPA instituted a 'no significant new use* policy
(Table 5). This policy continues to apply to chemicals sutDject to reregistrafiorL In
addition, for chemicals not subject to reregistration. we will not issue a tolerance for a
significant new food use if the TMRC e>a:eeds the RfO and we do not have the data to
make an anticipated residue calculation that shows exposure to be below the RfD.

Rnally, some of the pestiddes on the enclosed tables are b^g evaluated in
ERA'S Special Review process. Enclosed is a list of chemicals cunrently in the Spedal
Review process (Table 6). We will be reviewing the dietary risks of these chemicals as
part of the Spedal Review.

Since TMRC estimates can be vary misleading, the apparent RfO exceeders on
the endosed tables should not be a cause for alarm. As explained above, TMRC
values overestimate acbial dietary exposure to pestidde residues. The latest results of
the Agenc/s RfD exceeders project confirm this conduslon. However, the TMRC/RfO
compatison is a usefui guide to help ftio Agency determine the need fbr additional
regulatory dedsJoris'cr dietary exposure analyses.

If I may be of further assistance, please let me know.

Sincerely yours,

^^^^jj^^^^ c;i><:fe^

LLnda J. Rsher
Asastant Administrator
Enclosures

144

FoodSafe Program,
Davis. CA. July 18, 1994

Ms. Christine L. Gillis,

U.S. Environmental Protection Agency, Office of Pesticide Programs, Policy and Spe-
cial Projects Staff (7501C), 401 M Street SW., Washington. DC.

Dear Ms. Gillis: Thank you for soliciting my comments on the EPA's preliminary
proposal to "reinvent" the process for establishmg pesticide tolerances. I am Dr. Carl
Winter and I direct the FoodSafe Program of the University of California at Davis
in addition to serving as Associate Extension Food Toxicologist in the Department
of Food Science and Technology. My research and outreach activities have focused
upon the scientific, regulatory, and policv aspects of food safety with respect to pes-
ticides; I have published numerous tecnnical and lay articles on the subject and
have twice presented invited Congressional testimony. In my 7 years as a faculty
member at the University of California I have not received any program funding
from the agricultural, chemical, or food industries.

From the proposal's executive summary, it appears that the major goal of the pro-
posed changes is to elicit public confidence in tne protective ness of the food supply
by improving public health protection and by making the tolerance setting system
easier to understand. While the document reads well and incorporates several inter-
esting ideas, I remain skeptical that adoption of the proposed changes would provide
any increase in public health protection. In addition, the processes described to
"reinvent" tolerances would seem to make the system more difficult to understand.

A central premise of the proposal seems to be that creating new tolerances for
processed foods and at the retail level, coupled with reducing some tolerances for
raw agricultural commodities, will provide additional consumer protection from pes-
ticides. From a theoretical standpoint, this can be shown to be the case since the
TMRC (or TMDI) would be lowered. In the real world, however, such changes to the
tolerances would not result in any decrease in consumer exposure to pesticides since
the changes are unlikely to affect pesticide use patterns. (This issue is described in
more detail in a recent article [C.K. Winter, Pesticide tolerances and their relevance
as safety standards. Regulatory Toxicology and Pharmacology, 15: 137-150, 1992]).
Thus, pesticides will continue to be used as they have been in the past, and residue
levels will therefore be unaffected. It may be argued that enforcement of the new
and/or lower tolerances could lead to a greater percentage of illegal residues and sei-
zure of offending food samples would decrease consumer exposure to such residues.
From a practical standpoint, however, given the low anticipated incidence of over-
tolerance residues, the low sampling rates, and the difiiculty in preventing illegal
residues from reaching the consumer, the health benefits to consumers from more
rigorous enforcement of the new tolerances would be negligible and certainly would
not justify the expense of additional monitoring of different food forms.

The procedures described for the establishment of tolerances for processed and re-
tail foods imply that accurate data exist to demonstrate the effects of postharvest
factors such as washing, peeling, cooking, canning, transportation, etc. upon pes-
ticide residue levels. While some data do exist, it is my impression that a majority
of data is lacking when one wishes to consider such postharvest effects on specific
pesticides and specific processed and retail food items. Generation of such data
would be expensive, time-consuming, and of little actual value to consumers given
the insignificant impacts on consumer exposure to pesticides if the new tolerances
are established.

The new tolerances would serve to provide additional confusion, rather than clari-
fication, to consumers, food producers, and food processors by making an already
complicated regulatory system even more difficult to understand. The new toler-
ances could also have ramifications to international trade and could possibly be
viewed as nontariff trade barriers which could trigger retaliation on the parts of
U.S. trading partners through adoption of new standards that would discriminate
against U.S. products.

The major problem with both the existing and proposed tolerance setting systems
is the reliance upon the TMRC (TMDI) approach for estimating consumer exposure.
As is pointed out in the proposal, such an approach yields highly exaggerated expo-
sure estimates and fails to take into account the actual residues consumed. Just as
the inflexibility of the Delaney clause has led to irresponsible regulation of pes-
ticides, continued and prescribed use of TMRCs and TMDIs as regulatory tools will
ensure that pesticide tolerances will not be health-based and may provide obstacles
to the safe and effective use of pesticides which are not justified by scientific con-
cerns.

It is apparent that the procedures described for "reinventing" pesticide tolerances
were crafted to justify continued regulation of pesticides for which the existing

145

TMRCs exceed the reference doses or provide an oncogenic risk of greater than
10 "6. As such, I consider the procedures mathematical manipulations designed to
enhance consumer confidence and satisfy the National Academy of Sciences' rec-
ommendation that tolerances be more "health-based" rather than as blueprints for
serious efforts to enhance the safety of the food supply.

It is not necessary to "reinvent" tolerances. As is mentioned in the proposal, tech-
niques already exist to determine EMDIs and EDIs which incorporate realistic resi-
due, pesticide use, and postharvest data. It is these exposure estimates that EPA
should use to determine if consumers are protected from pesticide residues. If the
EPA concludes that adequate protection exists, tolerances should be established at
the field level necessary to ensure adequate pest control, as is currently the case.
Replacing these more accurate exposure estimates with an unrealistic mathematical
construct such as the TMDI serves no practical purpose but unnecessarily increases
bureaucratic burdens and complicates an already confusing process.

While I do not support your proposal to "reinvent" pesticide tolerances, I am sup-
portive of some of the proposed changes. Changing the terms "tolerances" and "The-
oretical Maximum Residue Contribution" to "Maximum Residue Limits" and 'Theo-
retical Maximum Daily Intake," respectively is certainly warranted. I also applaud
your efforts to reanalyze the residue field trial data used to establish the tolerance
on raw agriculture commodities to eliminate the effects of "outliers" on the tolerance
levels. In some cases, the tolerances are probably far greater than they have to be
to ensure that growers using pesticides properly can be in compliance; it is also like-
ly that improper pesticide use may not result in illegal residues in cases where the
tolerances nave been skewed due to the presence of "outliers."

Thank you for providing me with the opportunity to comment upx)n your proposal.
I agree that the processes for regulating pesticide residues are enormously complex
and difficult to explain to the general population, since tolerances are truly not
health-based but represent enforcement tools designed to determine if pesticide ap-

flications have been made in accordance with label directions. To clarify the issue,
am currently preparing a manuscript for publication in Regulatory Toxicology and
Pharmacology proposing a new system for establishment of "safety" standards for
pesticide residues as companions to the existing enforcement tolerances (or MRLs).
Such an approach could provide the impetus to shift, the focus of regulatory monitor-
ing from field enforcement to health enforcement, and could also assist in the inter-
pretation of differences between United States and foreign residue standards and
allow the health significance of technical residue violations (e.g., pesticides detected
on commodities for which they are not registered) to be determined. I would be
pleased to share some of my ideas on this suoject with you at your convenience.

Sincerely,

Carl K. Wintter.

20-127 (152)

5°fI,Vli;UBUCU8RAnv

3 9999 05981 687 4

ISBN 0-16-052077-0

9 780160"520778

90000

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