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FOOD QUAUTY PROTECTION AQ OF
HEARINGS
BEFORE THE
SUBCOMMITTEE ON
HEALTH AND EN^TRON'MENT
OP THE
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTH CONGRESS
FmST SESSION
HJl.1627
JUNE 7 AND 29, 1996
Serial No. 104-76
STANFORD
LIBRARIES,
P65-48
PriDted for the lue of the Committee on Commerce
DEPOSITORY '
U.8. OOVERNHENT PRINTING OFFICE J'-'^^'^ "-' ' j
^ WASHINOTON : IMS
For uile by Ibc U.S. Oovcmmenl Prinltng Office
Supoiniendem of IXxnarrniivConEresskinal Sales Office. Washington, DC 20«2
ISBN 0-16-052e71-X
COMMITTBE ON COMMERCE
THOMAS J. BULEY, JR.. VlrginU, Chairman
CARLOS J. MOORHEAD. CalifbriiU,
Viet Cliairman
JACK FIELDS, Tazai
MICHAEL G. OXLEY, Ohio
MICHAEL BILIRAKIS, Florida
DAN SCHAEFER. Colorado
JOE BARTON, Tou
J. DENNIS HASTERT, Illinoii
FRED UPTON, Michigjio
CLIFF STEARNS, Florida
BILL FAXON, New York
PAUL E. GILLMOR, Ohio
SCOTT L. KLUG. WiMoiuiii
GARY A. FRANKS, Connacticut
JAMES C. GREENWOOD, Pnuuybani*
MICHAEL D. CRAPO. Idaho
CHRISTOPHER COX, California
RICHARD BURR, North Carolina
BRUN P. BILBRAY, Califonua
ED WHITFIELD, Keotudv
GREG GANSKE, Iowa
DAI4 Fltl^A, Now Yorii
CKABin tKOmQOD. QMTiia
RICK WHITE, Waahincton
TOMnOOBURt^ OUhhoma
J/MSa E. OtaDtMJiH, Chitf rf Staff
C1URLB8 L. iNaBBBETBON, Oentral Counaei
Auw J. Roth, liiaarity Staff Dinctor and Chief Caunttl
JOHN D. DINGELL, Michigan
HENRY A. WAXMAN, CallfbmU
EDWARD J. MARKEY, Maaaachuaetta
WJ. -BILLY" TAUZm. Louiaiana
RON WYDEN, Oregon
RALPH M. HALL, Texas
JOHN BRYANT, Taa«
RICK BOUCHER, ^^rgima
THOMAS J. MANTON, New Yorit
ED0LPHU8 TOWNS, New York
GERRY E. STUDDS, Maaaaehuaetta
FRANK PALLONE, Ja, New Jersey
SHERROD BROWN, Ohio
BLANCHE LAMBERT LINCOLN, Aikanaaa
BART GORDON, Tenneaaee
ELIZABETH FUR^, Oregon
PETER DEUTSCH, Florida
BOBBY L. RUSH. lUinda
ANNA G. ESHOO, California
RONKLINK, Peniwylvaiiia
BART STUPAK. Michigan
SUBCOHUITTEE ON HEALTH AND ENVIBONHENT
MICHAEL BILIRAKIS, Fknida, Ckairman
J. DENNIS HASTEST, Rliwria,
Vice Chairman
JOE BARTON, Teiaa
FRED UPTON, MichigM
CLIFF STEARNS, Florida
SCOTT L- KLUG, Wiaconain
GARY A FRANKS, Connecticut
JAMES C. GREENWOOD, Pemiaylvania
RICHARD BURR, North Carolina
BRIAN P. BILBRAY, Califomia
ED WHITFIELD, Kantucky
GREG GANSKE, Iowa
CHARLIE NORWOOD, OwirgU
TOM COBURN, Oklahoma
THOMAS J. BUIXY, JR., Virginia,
(Es Offido)
HENRY A. WAXMAN, CaUfomla
SHERROD BROWN, Ohio
BLAN CHE LAMBERT LINCOLN, Ai^anaas
PETER DEUTSCH, Florida
BART STUPAK, Michigan
RON WYDEN, Oregon
RALPH M. HALL. Te>a*
JOHN BRYANT, Tocai
EDOLPHUS TOWNS, New York
GERRY E, STUDDS, MaMMbtisett*
FRANK PALLONE, Jr., New Jeraey
JOHN D, DINGELL, Michigan
(ExOfBdo)
CONTENTS
Hearings hdd on:
June 7, 1996 1
June 29, 1996 129
Testimony of:
Briekey, Caroljm, Executive Direcbs', National Campaign Ra Pesticide
Policy Refbnn 103
Chuda, Nancy Gould, on behalf of Colette Chuda Environmental Fund
and Children's Health Environmental Coalition 133
Dagmn, Juanita, Executive Vice President for Government Affairs and
PuUlc CommunicationB, National Pood Processors Association 60
Eichler, Bob, Portage, MI 143
Elworth, Larry, Special Assistant for Pesticide Policy, Departinent of
Aariculture 11
Feldman, Jay, Executive Director, National Coalition Agoinat the Misuse
of Pesticides 91
Gianessi, Leonard P., Seniu- Research Associate, National Center fbr
Food and Agricultural PoUct 37
Goldman, Lynn R., Assistant Administrator, OfBce of Prevention, Pes-
ticides, and Toxic Substances, Environmental Protection Agency 8
Gray, George M., Harvard Center for Risk Analysis, Harvard School
of PubUc Health 41
Hopkins, Edward, Environmental PoUcy Director, Citizens Action 149
Landrigan, Philip J., Chaitman, Department of Communis Medicina,
Mount Snai Medical Center 138
Olson, Erik, on behalf of Natural Resources Defense Council 77
Reigart, J. Routt, onbehalf of American Academy of Pediatrics 144
Schultz, WiUiam B., Deputy Commissioner for Poli<7, Food and Drug
Administration 10
Smith-DeWaal, Caroline, Director, Food Safe^ Program, Center for
Science In the Public Interest 164
Stolte, Dennis, American Farm Bureau Federation 67
Vroom, Jay J., President, American Crop Protection Association 107
Winter, Carl K., Director, FoodSafe Pnwram, University of California 34
Wolff, Mary S., Mount Sinai School of Medicine 147
Ziller, Steven, Vice President, Science and Technical AfEkira, Groceiy
Manufacturers Association of America 66
Material submitted for the record by:
Chemical Producers and Distributmv Association, prepared statement
of 118
National Association of State Departments of Agriculture, prepared state-
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DiBiiizcdbjGoogle
FOOD QUALITY PROTECTION ACT OF 1995
wednesday. june 7, isob
House of Representativbs,
Committee on Commerce,
Subcommittee on Health and Environment,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:10 a.m., in room
2 123 , Raybum House Office Building, Hon. Michael Bilirakis
(chairman) presiding.
Members present: Representatives BUiralus, Burr, Bilbray,
Whitfield, Ganske, Cobum, Bliley (ex officio), Waxman, Brown,
Lincoln, Towns, and Pallone.
Staff present: Mary M. McGrane, m^ority counsel; Howard
Cohen, miuority counsel; and Kay Holcombe, minority professional
staff member.
Mr. Bilirakis. Good morning. I am pleased to call this hearing
on H.R. 1627, the Food Quality Protection Act of 1995 to order, and
I'm pleased that this bill, introduced by Mr. Bliley and Mr. Towns,
enjoys strong bipartisan support.
I would liKe to announce in advance that since we have a long
day ahead of us, with four different panels, I'm going to try to stick
to S-minute rules. Insofar as opening statemehts are concerned, I
will afford 5 minutes to myself and to the ranking member and
then 3 minutes to other members of this panel and then go on
down to the witnesses.
In 1968 Congress passed the Delaney Clause which establishes
a zero cancer risk standard for food additives including pesticide
residues. As we are aware from the current court decisions, the
Delaney Clause does not allow consideration of whether the cancer
risk is negligible, meaning extremely small, or whether there are
other beneficial characteristics of the product.
Since the passage of the Delaney clause, science has developed
sophisticated methods to detect snialler and smaller residues. For
example, today we routinely measure in parts per trillion, so we
can find some of these carcinogens in fooos even though they are
present in such minuscule levels that they pose no hazard whatso-
ever.
Until recently, the Environmental Protection Agency regulated
pesticide residues using a de minimis standard. This standard al-
lowed EPA to avoid applying the terms of the Delaney standard lit-
erally when to do so would yield pointless results. In effect, the
agency said that pesticide residues at certain levels were harmless.
But because of a court decision, EPA can no longer take a de
minimis approach and must strictly enforce the 1968 law. Con-
(1>
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sequently, today we are in a position where all sides admit that the
Delaney Clause must be reformed. This was clearly the position of
the National Academy of Sciences which issued a report several
years ago which made a convincing case for the necessity and bene-
nts of reforming the Delaney Clause.
The Food Quality Protection Act of 1996 will modernize, I think,
our pesticide laws, keep our food supply safe, and permit EPA to
take speedier action when the agency decides a haz^dous chemical
must be taken off the market. By simplifying and strengthening
current law, H.R. 1627 will result in less regulation, less bureauc-
racy at both the Federal and State level, and be less costly to o>n-
sumers and taxpayers.
I look forward to the testimony and comments of our witnesses
today and call upon the ranking member, Mr. Waxman.
Mr. Waxman. Thank vou very much, Mr. Chairman.
Our pesticide laws ao need reform. The National Academy of
Sciences told us that 2 years ago when it released its report on pes-
ticides in the diets of infants and children. The simple fact is, our
current system doesn't ensure that the health of our children is
adequately protected. Unfortunately, the bill before us is not the
kind of reform we need. It is an extreme measure that would sub-
stanti£itly weaken protection against pesticides. It is the agricul-
tural lobbyist's dream and potentially the consumer's nightmare.
In this Congress we have seen a deliberate and sickening on-
slaught on our Nation's food safety laws. Each year thousands of
people die from contaminated meat and poultry; millions of con-
sumers are made sick. The Department of Agriculture proposed
regulations in February to deal with this health emergenqf by im-
proving the quality of meat inspections, and how did the House of
Representatives respond? We passed legislation imposing a morato-
rium on the meat safety regulations. We specifically rejected an
amendment to exempt these regulations from the moratorium.
Seafood safety is another big problem. Tens of thousands of
Americans get sick from eating contaminated seafood each vear.
The FDA is trying to issue regulations to ensure the safety of sea-
food. The agency told us that this effort would be delayed by years
if we paralyzed the regulatory system by enacting H.R. 9. what
was our response? Again we ignored public health and pEtssed H.R.
9 without exempting vital health regulations like the seafood safety
regulations.
The bill before us today, H.R. 1627, is another assault on food
safety. As drafted, it would virtually repeal the pesticide provisions
of the and Federal Food, Drug, and Cosmetic Act, the cornerstone
of our food safety laws. It does this by prohibiting EPA from acting
under this law until after that agency has taken action under the
far looser standards of FIFRA.
I believe we need a balanced bill. If we Eire going to repeal the
Delaney Clause, then we also need to adopt changes that strength-
en our food safety laws. For this reason, I m introducing today new
food safety legislation, the Pesticide Safety and Right to Know Act.
This bill has three simple provisions.
First, it says EPA must use a common sense test to protect kids.
The agency must determine whether a pesticide is reasonably an-
ticipated to harm children. If it is reasonably anticipated that chil-
dbJt^OOgle
dren will be hurt, the tolerance cannot be issued. To ensure that
sound science is used in making these common sense determina-
tions, the bill directs EPA to follow the recommendations of the Na-
tional Academy of Sciences. Second, the bill provides that this same
common senae test must be used to protect women from breast can-
cer; and, finally, the bill has a right to know provision.
Because H.R. 1627 would repeal the Delaney Clause, it will be-
come possible for pesticides containing carcinc^ns to enter the
processed food supply. The right-to-know provision says that if the
worst of these pesticides is known and probable human carcinogens
are used on foods a labd notifying the consumer must be put on
the food.
Under H.R. 1627, it will be legal for foods like baby foods and
apple sauce to be sprayed with known human carcinogens. If our
Government wont be allowed to stop this practice, then we need
to give consumers the ability to fend for themselves. Consumers
ought to have a right to know whether these proven dangerous
chemicals have been added to their food. The Pesticide Safety and
Right to Know Act will give them that right.
We should have an opportunity to consider whether H.R. 1627
would be improved by amending to it incorporate the policies in
this Pesticide Safety and Right to Know Act, and for this reason
it is important that this subcommittee schedule a second day of
hearings on this matter.
Mr. Chairman, I look forward to working with you on this legis-
lation, but before we pass a bill I hope it will be a balanced one
to protect the consumers.
I yield back the balance of my time.
Mr. BnjRAKis. The gentleman's time has expired. I thank the
gentleman.
Mr. Bliley, the chairman of the full committee.
Mr. Bliley. Thank you, Mr. Chairman. I appreciate your calling
this hearing on £in issue of importance to all Americans.
The United States enjoys the world's safest most abundant and
affordable food supply. Maintaining the wholesomeness, the vari-
ety, and the low cost of our Nation's foods is critical. Each year
American farmers lose about 30 percent of their harvest to pests,
disease, and spoUage even with pesticides. Therefore, it is critical
that farmers be allowed to continue using safe and effective crop
{)rotection tools. But because of our Nation's outdated pesticide
aws, the potential exists for farmers to lose many of the vital crop
protection tools they need and for foods to become more expensive
to grow and sell, less abundant, and poorer in quality.
This hearing is particularly timely because of recent court deci-
sions involving the Delaney Clause which could prohibit the use of
a growing number of chemicals that pose little or no risk of cancer
wmle allowing the Food and Drug Administration and the Environ-
mental Protection Agency no discretion in their food safety policies.
Existing pesticide regulations greatly exaggerate the degree of
risk and ignore imy benefits to society from the use of safe crop
protection tools. We need laws that will give EPA the flexibility it
needs to regulate pesticide use as well as ensuring that strong safe-
ty standards will remain in place, particular^ safeguards for the
health of infants and children. The benefits of'^a diet high in fruits
DigilizcdbyGoOgle
and vegetables are well documented, but our existing pesticide
laws could bave the unintended effect of making these foods more
expensive and less readily available.
We need to ensure that all American consumers have an ade-
quate, affordable supply of &uits and vegetables and in fact are en-
couraged to include more fruit fruits find vegetables in their diets.
I believe that the bill which is the subject of today's hearing, H.R
1627, would accomplish many of these objectives.
Mr. Chairman, I applaud you for holding this hearing, and I
stand ready to work with you on this important issue. I yield back
the balance of my time.
Mr. BiLKAKis. I thank my chairman.
Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman. Let me begin
by thanking you for calling this hearing.
This hearing gives us an important opportunity to begin the
process of updating and modernizing our Nation's pesticide laws.
As a cosponsor of this legislation for the past two Congresses, I am
pleased that we finally appear to be moving forward with a reform
measure which will allow the EPA to base its regulation of pes-
ticides on a sound science based assessment of refil world risk. H.R.
1627 will replace the outdated Delaney Clause with a flexible
standard that makes a risk determination based on modem science
and allows the use of substances that pose a negligible risk to pub-
lic health as recommended by the National Academy of Sciences.
In recognition of the fact that the Food, Drug, and Cosmetics Act
should be amended to include specific provisions to ensure ade-
quate consideration of the health of infants and children, this bill
grants reasonable discretion to the EPA to determine appropriate
safety testing requirements for infants and children. This measure
also responds to earlier recommendations that the dual standards
for raw and processed food tolerances be replaced with a single
science-based standard. That makes sense, and I support it.
Mr. Chairman, I look forward to workiiig with you in trying to
strengthen our laws because I think the time has come for us to
do that, and I applaud you for moving forward. I look forward to
hearing from our witnesses because I think the time has come
when we should make these changes.
I yield back.
Mr. BnjRAKis. I thank the gentleman and wanted to make it
clear he not only is a cosponsor of the legislation, he is a chief origi-
nal cosponsor of the legislation.
Mr. Ganake — ^Dr. Ganske — 3 minutes please.
Mr. Ganske. Thank you, Mr. Chairman.
I'm very pleased to be a cosponsor of H.R. 1627, the Food Quality
Protection Act. This important common sense legislation is long
overdue. Although I'm new to Congress, I understand that in the
past 16 years Congress has held more than 25 hearings that in-
cluded testimony that impacted on the Delaney Clause. While there
is an extensive record on why this outdated relic needs to be
changed, I understand the need to continue to reeducate certain
members of the committee on the latest changes in the field of
science.
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Ab I aaid, the Delaney Clause is a relic that is scientifically out-
dated and should be changed. Since 1977 two National Academy of
Science reports have been published that recommended Delaney
Clause reform. Following the 1987 NAS report "Regulating Pes-
ticides in Food, the Delanev Paradox," the EPA announced it would
incorporate the recommendations of the report. Several groups and
individuals, including the Nationzil Cancer Institute, the American
Cancer Society, the American Medical Association, and former Sur-
geon General C. Everett Koop, supported changing the existing pol-
icy. Unfortunately, the EPA's actions were challenged in court and
we find ourselves here today.
The old era of congressional policy by committee command with-
out the complete scientific facts is over. Today's technology and the
level of scientific enertise requires ua to act. The use of sound
science will ensure uiat our Nation's food safety policy flows from
a rational, logical basis. Sound science will also ensure that our
Nation's food supply will continue to remain safe.
Carol Browner, the current EPA Administrator, herself stated in
a February 1993 New York Times article, "We do not believe that
consumption of these pesticides as residues in processed food prod-
ucts is a threat. These foods are safe." Before we hear any horror
stories today about Republican efforts to turn back food safety and
how this legislation will poison our children, our spouses, and our
parents, let me point out that H.R. 1627 has received strong bii)ar-
tisan support. Nearly 30 members from the other side of the aisle
have cosponsored this legislation already. This is a bill about com-
mon sense, it is a bill about ensuring s^ety, and it is a signal that
reform has come.
Mr. Chairman, I thank you for your efforts on this issue, and I
appreciate your leadership.
Mr. BiURAKls. I thank the gentleman, and his time has expired.
Mr. Brown, 3 minutes please.
Mr. Brown. Thank you, Mr. Chairman.
It is good to see George Orwell is back in front of our committee.
First the Republican leadership opposes an increase in the mini-
mum wage and they call it the Job Creation and Wage Enhance-
ment Act. Then the Republicans propose lowering the earned in-
come tax credit and they call that the American Dream Restoration
Act. Then they refuse to take Social Security off budget in the bal-
anced bucket amendment and call that the Senior Citizens Fair-
ness Act. And now that they are moving forward in their typically
extreme way on fbod safety issues and pesticide issues, they call
that the Food Quali^ Protection Act of 1995. That kind of Orwell-
ian thinking is fi*anUy what makes people cynical about this proc-
ess, about t£iB Congress, about this new mEgority.
I agree that the Delaney Clause needs reform. I think we can
move forward in doing that. But it doesn't mean rolling back the
kinds of food safety and health laws around which this society has
built a consensus.
Just recently Government, over the opposition of the food indus-
try year after year after year, put nutrition labeling on virtually
every food iton you buy in the grocery store. I think every one rf
us knows more about dietary fiber and more about fat and more
about sodium when you pi^ ^P ^ ^^^^ o^ soup at the grocery 8t<H>e
DigilizcdbyGoOgle
and you look at this brand and that brand, and how much Bodium,
and how much dietary fat, and how much sugar content, and in all
of nutrition labeling that the food industry opposed that govern-
ment finally was able to do to get more information into consumers'
hands, that same kind of move, when government can be involved
and can help to build a consensus on making the Eiir cleaner and
tibe water safer and our food purer, only meikes sense.
I represent an area of Ohio whi(ii has some of the highest breast
cancer rates in the country and some of the highest prostate cancer
rates in the country, and I represent an £irea where a lot of preg-
nant women gave birth to babies with birth defects because it was
attributed in one m^jor study over the last mstny years to consump-
tion of \arge amounts of fish from Lake Erie, and I don't want to
see us move in the wrong direction. I think we need to reform the
Delaney Clause, but this Orwelllan double apeak and calling this
the Food Quality Protection Act just begs the question a little bit
too much, Mr. Chairman.
Thank you.
Mr. BiLiRAKis. The gentleman's time has expired.
Mr. Whitfield.
Mr. Whitfibld. Thank you, Mr. Chairman.
I'm just going to commend the chairman for bringing this meas-
ure to the committee for consideration. I think it is a balanced ap-
proach that looks after the benefit of the farming community which
18 vital to this Nation's economy, as well as display our concern for
the safety of children and citizens across the country. So, I com-
mend the chairman and look forwEuxl to the hearing.
Mr. BILIRAKIS. I thank the gentleman.
Mr. Bilbray.
Mr. Bilbray. Mr. Chairman, I appreciate the chance to be able
to participate in this process.
As a cosponsor, my interest is not in the protection of those who
may use certain products for the production of agricultural activi-
ties. My concern here comes from a background of over a decade
of trying to protect the public health for a population larger than
the State of Kansas, and though some of our colleagues may feel
that overregulation or regulation cannot be overdone from a public
health point of view, let me assure my colleagues that there is a
mqjor, major threat to the public well-being by not having regula-
tions based on science. Too often, there has been in the past this
concept that if we overregulate we will still have an added safe^
factor. Well, that same mentality was used by a boy who cried wou
again and again and again, and we all know what happened to that
boy.
My concern is that we need to get the science base when we
make these evEtluations, because it is not just the credibility of
those of us who are Members of Congress but the credibility of the
entire system that warns our consumers of potential problems. As
somebody who comes from a public health background, the credibil-
ity of our warnings have been systematically destroyed by irrespon-
sible use of the warning system, and California probably ranks
bluest, Mr. Chairman, in that. We have posted that anything and
eveiything may have a potential problem, and thus the public re-
fiises to acknowledge that a warning carries any wei^t any more.
DigilizcdbyGoOgle
So I would say to my colleagues who point out that they want
to protect the public health that we not only have a right, we have
a reaponBibility to make sure that when we post a wamine that it
is based on saence. We should not be confused with the belief that
somehow an overreaction creates an element of safety.
When a citizen reads a warning, they need to know that that
warning is based on science so that they can take it with some
credibilily, and believe in what we as people in government have
asked to be posted. If not, ell the warnings that we place out there
have no credibility with our citizens. I think that that is the issue
here, that our warnings do bear science so our citizens can feel
comfortable with the fact that when they see a warning it is appro-
priate, rather than what we have seen more and more, especially
in my home State where they don't even bother to consider a warn-
ing because it has no credibility with the average citizen.
Mr. Chairman, I appreciate this chance to participate, and for
the public health, I look forward to moving this legislation.
Mr. BILIRAKIS. I thank the gentleman for his opening statement
based on his own personal grassroots experience in the State of
California.
Mr. Burr, 3 minutes please.
Mr. Burr. Mr. Chairman, I would ask unanimous consent to put
my opening remarks in the record.
Mr. BiLiRAKiS. Without objection.
Mr. Burr. I find myself cramming a piece of paper once again
from a Federzil agency on testimony that we had hoped to get 48
hours in advance only to receive it a little over 12 hours in ad-
vance, and I hoi>e, Mr. Chairman, that in the future we will stress
this because it seems that every agency of the Federal Government
that comes in puts us in a situation where we have absolutely no
idea what their remarks or their testimony is going to be.
I yield back.
Mr. BiLIRAKIS. I thank the gentleman.
[The prepared statements of Hon. Richard Burr and Hon. Fred
Upton follow:
Thank you, Mr. Chaiiman.
I appreciate thia opportunity to work with my coUeanies toward repealing an an-
ti<niated relation which has long since outiived it* efl«ctiveneM.
Mr. Chairman t^ repeal of the Delaney Clause follows the precedent that this
committee haa eatablished throui^out the 104th Congress. H.R 1627 attempts to
invoke common aenae along with acme sound science in the determination of pes-
ticide aafet^. It takes into consideration the risk^en^t analysis that thia committee
helped establiah thia year, while keeping in mind the end goal of producing a safe,
adeiquate, wholeeome and economical domestic food supply. In a nutahell, under this
bill, everyone wins.
As an original coaponaor of H.R. 1627, I look forward to the expeditious consider-
ation of thia bill, whidi keeps modem technology from becoming a hindrance to sue-
ceasfiil food production. By aetUng one tolerance standard for pesticide residues in
both raw and processed food, ana by baaing it on the risk to numans rather than
laboratory rata, we are codiMng the long awaited step that even the EPA haa at-
tempted to take — replacing the Delaney Clause with a negligible risk standard that
makes good senae,
ThaiUE you to all of our witneaaes. I look forward to tbe Inai^t you have to oSisr
on thia timely and n o cesaary change to current poli^.
DigilizcdbyGoOgle
^lunk yoUj Mr. Chairmui.
Ab on (Humal coaponstr of H.R. 1627, Choimuui Bliley's Food Quality Protection
Act, I am ffM to tM this iMue come before the Bubeommittee tod&jr and I look for-
wud to the testimony rfour witnoMee.
H.R. 1627 ia an important atep in reforming food safety laws. While the ooal c^
the Delaney Clause ia commendable, the science used in fonning this 1968 law is
obsoleto. It Is hifdi time to re-exomme this issue usin^ the best available science
todajr. I am coimdent that the Food Quality Protection Act makes the needed
cbansea to laws governing peetiddes and food safely.
As we woi^ on this Important issue that will Impact vwvrj peraon living in Amw-
ica, m; aim will be to ensure a food supply that remains safe, as well as affordable.
Thank you and I yield back the balance of my time.
Mr. BnJRAKIS. Dr. Cobum.
Mr. COBUBN. I have no opening statement, Mr. Chairman.
Mr. BiLlRAKis. I thank the gentleman.
That completes, I believe, our opening statements for this morn-
ing. We will go then to our first panel. Dr. I^n Goldman, who is
the assistant administrator of the Office of Prevention, Pesticides,
and Toxic Substances with the EPA. She is accompanied by Mr.
Bill Schultz, an alumnus of the staff of this committee.
It is good to see you again. Bill.
He is the deputy commissioner for policy with FDA. And also Mr.
Lawrence Elworth, special assistant for pesticide policy with the
Department of Agriculture.
Dr. Goldman, why don't we start with you, and, as I understand
it, the gentlemen wish to make brief statements in addition to
yours. Why don't we start with you for 6 minutes please.
STATEMENT OF LYNN R. GOLDMAN. ASSISTANT ADMDaS-
TRATOR, OFFICE OF PREVENTION, PESTICIDES, AND TOXIC
SUBSTANCES, ENVIRONMENTAL PROTECTION AGENCY; AC-
COMPANIED BY WILLIAM R SCHULTZ. DEPUTY COMMIS-
SIONER FOR POUCY, FOOD AND DRUG ADMINISTRATION;
AND LARRY ELWORTH, SPECIAL ASSISTANT FOR TOSTICIDE
POUCY, DEPARTMENT OF AGRICULTURE
Ms. Goldman. Good morning. Chairman Bilirakis and sub-
committee members.
We are pleEised to appear before you tod^ to discuss the Food
Quality Protection Act of 1995, H.R. 1627. The administration ap-
fireciates your interest in reforming our pesticide and food safety
aws to ensure that they provide consumers with a safe, abundant,
and affordable food supply and allow for advances in science.
As you know, the administration proposed comprehensive pes-
ticide reform legislation in the last Congress amending both FIFRA
and FFDCA, legislation that was developed in coordination be-
tween FDA, EPA, and USDA. While I understand that amendment
of FFDCA is the primary focus of today's hearing, I will also briefly
discuss the FIFRA provisions of this bul.
We must modernize FFDCA in order to establish a single health-
based standard for residues in food. This public health standard
must take into account potentially sensitive populations, especially
infants and children, the most vulnerable members of our society.
Sound pesticide reform legislation must also provide the fees re-
quired to complete reregistration mandated by Congress to ensure
DigilizcdbyGoOgle
that pesticide registrations are current with scientific standards of
today. Some proposed FFDCA changes may not adequately pre-
serve the food safety safeguards that American consumers expect
and deserve.
H.R 1627 would establish a single ne^gible risk standard for
tolerances for raw and processed foods. Although we agree on the
need for single health-based standard, it is unclear how the concept
of negligible risk would apply to noncancer risks. We believe that
a standard of a reasonable certainty of no harm makes more sense.
This does mestn a negligible risk for cancer, but it also means that
for noncancer effects, birth defects, neurotoxicity, and other effects,
we would have a reasonable certainty that none of those effects
would result from eating foods that have been legally treated with
pesticides. H.R. 1627 would allow risks that exceed a negligible
level to continue indefinitely if they were outweighed by the bene-
fits of the pesticide.
We believe that the broadly construed economic benefits lan-
guage contained in H.R. 1627 is not appropriate in a food safety
statute. H.R. 1627 would amend FFDCA to establish a single neg-
ligible risk standard for tolerances for pesticide residues in raw and
processed foods but would allow risks that exceed a negligible level
to continue indefinitely. The administration's proposalB for toler-
ance setting contain additional requirements direcuy responsive to
recommendations contained in the NAS report on pesticides in the
diets of infants and children.
While we acknowledge the efforts to collect the information, we
need to actually use the information to consider risks to children.
That is, we feel it is not enough to just gather the information on
children's diets and pesticide residues but we would like to see a
requirement that the EPA considers the diets and sensitivities of
children in setting tolerances.
We are concerned about the very broad scope of preemption
under H.R. 1627 because it extends to State and local statements
about the presence of pesticide residues in food like California's
Proposition 65, and we believe that the Codex language needs to
be clarified to ensure that American standards are not jeopardized.
Also, the coordination language in H.R. 1627 between FIFRA and
FFDCA could be interpreted to negate all of the FFDCA safe-
guards, including those aimed at protecting children.
Turning to the FIFRA provisions very briefly, while some of the
amendments reflect improvements over previous versions, others
would make achievement of public heiilth and environmental goEils
more difficult than current law. Notably, the cancellation provi-
sions in Title I combine the time-consuming features of both rule-
making and formal adjudicatory hearing procedures. Although it
specifies strict time limits, the bill simultaneously makes adher-
ence to these deadlines impossible. For example, provisions limiting
hearings to 20 days are unlikely to prove workable.
Also, and even more troubling is the conforming amendment
which appears to shift the burden of proof of a pesticide's safety
from the manufacturers to EPA not only for cancellation but also
for calling in data, and, as I said earlier, we feel that any FIFRA
provisions should address the need for renewal of the rer^stration
DigilizcdbyGoOgle
10
In conclusion, the administration and Congress must work to-
gether for common sense reform of our pesticide laws. We need to
reach agreement on legislation that will protect health, especially
the health of children. If we succeed, we will also maintain and en-
hftnce public confidence in the safety of the food supply, provide a
predictable environment for the agricultural community, and facili-
tate the development and adoption of safer, effective pest control
technologies.
Thank you again for the opportunity to join you this morning. 111
be pleased to answer any questions.
Mr. BiLiRAKlS. Thank you. Dr. Goldman. I'm sorry to cut you off,
but during the process of questioning I'm sure you will be able to
get more in.
Mr. Schultz, very briefly, a couple of minutes, please.
STATEMENT OF WILLIAM B. SCHULTZ
Mr. Schultz. Thank you, Mr. Chairman. I appreciate the oppor-
tunity to testify on H.R. 1627.
As the committee well knows, the Food and Drug Administration
is the principal agency charged with ensuring the safety of the food
supp^, but with regard to pesticides we don't set the Etllowable lim-
its, liie tolerances that regulate the residues that are allowed on
pesticides are set by EPA. Our job is to enforce those tolerances,
so it is within that context that I want to say a few things about
the bill. I would like to address both the enforcement provisions
and then just the experience we have in food safety.
We believe that H.R. 1627 is very constructive, and we are very
pleased that the subcommittee is holding this hearing, but the tes-
timony will identify the problems that we have with the bill. While
doing that, I want to emphasize that we are ready to work with
the members of the subcommittee, and we think there is a real op-
[lortunity to find common ground here, and to actually move legis-
ation that could have broad support. ,
Now in terms of the enforcement provisions, I want to just make
two points, identify two deficiencies. One is, when EPA approves a
pesticide it is essential that a way of detecting the amount of the
pesticide on the food also be identified. So if EPA says we are going
to allow there to be one part per million or one part per billion or
one part per trillion of the pesticide on the food, then when we do
our enforcement there has to be a method to ensure that we can
identify that. This bill does not have that requirement, Etnd it is
one that could be easily added.
Second, there need to be enforcement tools that allow the penalty
to fit the violation. Currently the FDA has a sledgehammer and a
flv swatter. When there is a violation we can have a criminal pen-
alty or we can send a letter, but we have very little in between.
For example, civil money penalties, an in-between penalty, I think
would be very useful in terms of effective enforcement.
Now I would like to turn to the substantive standard which is
so critical in this kind of legislation.
Mr. BiLiRAKis. Without objection, I'll give you another minute,
but try to finish it up, plesise.
Mr. Schultz. I was told we had 6 minutes, Mr. Chairman.
Mr. BILIRAKIS. Oh, were you told you had 5 minutes?
icd'bTGoOgle
11
Mr. SCHULTZ. Yes, I was.
Mr. BILIRAKIS. If you were told you have 5 minutes, you have 6
minutes.
Mr. SCHULTZ. Okay. Thank you.
Mr. BiLlRAias. So you have another 3 minutes.
Mr. ScHULTZ. Okay. Thank you very much.
The substantive standard is critical, and generally our laws have
a health-based standard for food additives, color additives, and ani-
mal drugs. That is a standard that works very well, find we believe
that it would be useful and very protective of the public hezilth to
look at that kind of standard which has worked and is absolutely
not being criticized.
In particular, we are concerned about the benefits provision in
this bill, which is quite broad. It has no limit on the amount of risk
that can be overridden by benefits, and there is no match. Mr.
Chairman, you can be the consumer, and maybe you are taking the
risk, but mjr benefit can override that risk, and there is no match
there. That is a huge problem.
I'm going to tick off a number of issues. First, the bill would
allow ^e FIFRA labeling provisions to override the food safety pro>
visions in the Food, Drug, and Cosmetic Act.
Second, there is a presumption that appears to allow inter-
national standards set by Codex to override the higher U.S. stand-
ards set by EPA and Congress.
Third, there is insufficient protection of children.
Fourth, ttie procedural provisions make it easier to get a pes-
ticide on the market than to take it off and really allow a field day
for lawyers in terms of delay.
And, finally, there are no provisions that assist EPA in its review
of existing pestiddes.
In conclusion, Mr. Chairman, the FDA and the administration
are committed to the reform of pesUdde laws in a way that works
for consumers and for fanners. We believe it is possible to achieve
this bfilance, and we are anxious to work with the committee to-
ward this end.
Thank you.
Mr. BnjRAKis. I thank you. Bill.
Mr. Elworth, you have 5 minutes.
STATEMENT OF LARRY ELWORTH
Mr. Elworth. Thank you. Thank you, Mr. Chairman.
The Department of Agriculture appredates your efforts and the
efforts of the members of your subrommittee to resolve issues of
long standing importance to USDA and to the agriculture commu-
nity as a whole. American farmers have an enormous stake in the
debate over food safety and pestidde legislation. Producers need a
regulatory system that provides them with safe and effective
means to manage pests in an environmentally and economically
sound manner.
That system must also account for the fact that pesticides are de-
liberately used for critical needs over a wide range of crops and
growing conditions. In that sense, the regulation of pestidde resi-
dues under the Food, Drug, and Cosmetic Act differs from the regu-
lation of other food additive residues.
DigilizcdbyGoOgle
12
More than anything else, farmers need a regulatory system that
provides assurance to consumers that their producte, Doth fresh
and processed, are safe and wholesome. Although agricultural pro-
ducers are not directly involved in the registration of pesticides or
the granting of tolerances, they have found that public controversy
and regulatory actions can have eeriouB conseauences for their abil-
ity to raise and market their crops. The laws tnat guide the evalua-
tion of pesticides must result in the confidence of consumers that
the fooa thev and their families eat is safe. This requirement as-
sumes added importance as our markets become more global. The
acceptance of our agricultural products as safe and wholesome in
the increasingly important international marketplace also depends
on our ability to adopt substantive scientifically based food safety
standards.
Mr. Chairman, it is clear that our food safety laws are in need
of reform. The Federal Insecticide, Fungicide, and Rodenticide Act
needs to be revised to ensure that producers have sufficient pest
management tools and to ensure that pesticides receive complete
review by current scientific standards. In FFDCA the current and
potential impacts stemming from the Delaney Clause smd the need
to account for pesticide residues in the diets of infants and children
are issues that require significant legislative attention. USDA be-
lieves that these issues should be addressed substantively and that
reform of the statute should reflect the basic concerns of all parties
that have a stake in these issues.
Although the authors of H.R. 1627 have made a substantial ef-
fort to reform both FIFRA and FFDCA, there remain significant is-
sues that merit additional attention and revision. Those concerns
are set out in detail in our written statement. At the same time,
we support the provisions for minor use and public health pes-
ticides as well as the efforts to ensure protection for the diets of
infants and children.
USDA is particularly heartened to see support for its efforts to
collect information on food consumption, pesticide residues, and
pesticide use, for the IR4 program for minor crop registrations, and
for the m^or commitment USDA has made to increase adoption of
integrated pest management. The President's budget has requested
the funds for these programs, and we hope to receive the necessary
resources to cany out tne work that Congress expects us to accom-
plish.
The main question before all of us today is whether we can con-
tinue to make additional progress in the drafting of legislation.
USDA and the administration have clearly stated our interest in
working with Congress to craft reasonable, common sense legisla-
tion. We are pleased to note that work has already begun with
members of the Agriculture Committee to resolve several important
iasues, and we look forward to working with the members of this
committee, as well, in the interest of sound legislative reform.
The issues, Mr. Chairman, before this committee are not new.
For virtually everyone in this room the issues have an all too famil-
iar and almost shopwom character. However, we once again have
the opportunity to make long overdue reforms which will move us
toward meeting the needs of agricultural producers and consumers.
Taking advantage of this opportunity will require a significant in-
DigilizcdbyGoOgle
13
vestment of time and good faith on the part of every party involved
to resolve these long-standing issues. We look forwsird to working
with you in that effort, Mr. Chairman, and with others who have
a sincere interest in improving our pesticide taws.
Thank you for your time, and we will be glad to answer any
questions you may have.
[The combined statement of Lynn R. Goldman, William B.
Sdiultz and Larry Elworth follows:]
Phepared Statement of Lynn R. Goldman, M.D., Assistant Adhinibtrator for
PsEVENrnoN, PE9nciDES AND Toxic Substances, Envibonhental Protection
AOENCr
1. INTRODUCTION
Good mornliig, Chairman BiliraUa and Subcommittee mombers. We an pleaaed
to aro«ar befbre you today to diwuac H.R. 1627, the Pood Quality Protection Act
of 1996. We appredat* your interest in k«r iaaues relating to pesticides and food
■afbty, and your dedication to the goal of refonning our pestldde laws to enaure that
Uiey rrilect current science and provide American consumers with assurance that
our food nvply >■ and will ranoln aafe, abundant, and affordable.
The iunies addressed in this legislation are complex-, some have been before Con-
grass for mcR« than two decades. Many stakehtdoos are involved. Consensus has
been difficult to achieve. The science underiying pesticide riak aaaesament is contin-
ually evolving, but our laws at times do not adequately accommodate scientific ad-
At tlw same time, it Is important to acknowledge that the Administration and
Congress have embraced common goals of maintaining and enhancing food safe^,
and ensurimt that the le^slatave dianges we make wiil allow for future progreas
in edence. 'ntese shored goals must be at the core of any peatiddafood safety re-
fbnn legislation. Althou^ there are many stakeholders with special interests, we
must never lose sight of our fiindamental purpose: to serve the public and protect
puUic health and the environment from unreasonable pesticide risks. Legislation
that embodies that purpose will sa£(«uard our food supply and maintain public con-
Bdenee in fbod safo^, while ensuring that health and the environment are protected
and producers have access to effoctive pest control technologies.
As you know, the Administration proposed conntrdienslve pestidde refwm legisla-
tion in the last Congress, amending both the Federal Insecticide, Fungicide, and
Redy tldde Act (FIFBA) and the Federal Food, ttpig. and Cosmetic Act (FFDCA).
FIFRA governs pesticide registration or Ucensiiu, indudinglabeling that prescribes
conditio^ under which pestiddea may be legalN used. F^X^ governs Mersnces,
or iMTiniiiin legally p ermia aible levels, for pestiade residues in foods.
We understand the FFDCA amendments In H.R. 1627 are the primary focus of
todv's hearing since they are und^ the jurisdiction of this Committee. We share
the bdief that changes are needed to achieve our goal of a sound, consistent statu-
tory flvmewoA for pestidde regulation. We must modernize FFDCA in particular
to estdilish a sinde, health-baaed standard for reslduaa in food. This public health
standard must take into account potential effods on significant subpopulations, es-
pecially Infknts and children— the most vulnerable members of our sodet^^-and re-
flect the recommendations of the 1998 National Academy of Sdences (NAS) report
on PttHadta in tha DitU oftnfiinti and Chiidrtn.
Finally, sound pestidde rsform legislation must provide the fees required to com-
plete on-floing raregiatTatian reviews mandated by Congress in 1986, and to ensure
that, in ue future, pestidde r^istrations are kept up to date with studlea reflecting
current scientific advances.
While the sponsors of H.R. 1627 share many of these goals, some provisions of
the bill as currently drafted would actually be mors unworkable than current law.
Othn provisions do not go fkr enou^ to achieve needed reforms, <x would have per-
verae, in all likelihood unintended, consequences. The Administration cannot sup-
port HJL 1^7 unless significant dioiwes are made.
Our testimony today will MghUght key pnivisiona of the pending bill. We hope to
worii with you, and with your colbagues on the Agriculture Committee, to develop
legislation that will advance our common goals and achieve meaningful refbrm.
DigilizcdbyGoOgle
tolerancea for peitidde residues in raw and proceeaed fooda. b
in defining what would qviali^ u "naglizible and allowa toler
poM greater than negliipole nski. It is also unclear how the o
duatrias hava compUad with thia standard which has aasured consumers that sub-
stanoaa pennittad to be uaed in fboda are, in Cut, safe.
n. FFDCA PROVISIONS
While thia Committee's jurisdiction focusee on FFDCA propoeala, it is clear that
ther e can be no effective peatidde regulatory reform legislation unless both FIFRA
and FFDCA are amended. Thia ptAnt waa evident to the aponaors of H.R. 1627, and
aa a reault they included substantial FFDCA changes in tue bill. We are concerned,
however, that oitae changes may not adequately preaerve the food aafe^ safeguards
that American consumers expect and deaerve.
Standards for ToUrance-aetting
H.R. 1627 would amend FFDCA to establlab a single netdi|pble risk standard for
* " " ' ' " ' ' '>oda. but it is leas specific
„ ^ _ —r^v — ' tolerances to be set that
pose greater than negli|pDle risks. It is alao unclear how the concept of "negligible
risk" would apply to non-cancer riska.
Under the Administration's proposals, tolerances for pesticide residues in all types
of food would be baaed on a strong, health-based standard, defined as "a reasonable
certain^ of no hBim" to consumers of the food. Thia is the standard of that cur-
rentlv appUea to many pesticides used in procesaed fooda. This new unifonn safe^
standara would replace the current standards in Sectiona 408 and 409 of FFDCA
and «n>uld be the baaia for regulating pesticide residuea in all ^rpes of fooda, wheth-
er raw tr proceaaad.
It ia significant that this standard haa been used by FDA since 1958 to evaluate
the aaiety of food additives and, since 1960, the safety of color additives, both of
which are widely used in procesaed fboda. Over the past 3D years, the regulated ii
,_.._,__ ,_ .,^ ^yj thiaatandard vi' ^ " " "--' '
... ^ jeuaedinfi>odsare,infii__.
Further, the AdminiBtration bellevet tJiat the q>pr(^rlate standard ia that toler-
ancea should provide a reasonable cwtain^ that no birth defocta, neurotozid^, or
other ntmcancar etfecte will reault fiimi eating fboda that have been legally treated
with paatiddes. To do thia, we ap^y "uncertainly' or "aafety" bctora whni we are
rearing on animal data alone, 'me National Research Council in ita report entitled
Science and Judgment in Ritk AtMaammU endorsed this approach.
Benefits CoTiaiderationg
Our Btarting point is that the FFDCA ahould have a health-based standard appli-
cable to pestiddea. Anv deviation from that prindple should be carefully juatined
uid specmcally tailored
However, H.K. 1627 doee not meet thia standard. It would allow uee of a pestidde
which poaea a greater than negU^le dietary risk, if the dietary riska to the
consumer are outweighed by the peatidde's "benefits." The specific lainguage of H.R.
1627 ia problematic for several reaaons.
First, H.R. 1627 requires EPA te consider the direct or indirect benefite of a pea-
tidde when the dietan riak fivm the peatidde is not aa great as the risks to health
or the environment of not uaing the pestidde. The le(ulation doee not place any
limit on how much dietary riak is acceptable to trade uf in this situation, and far-
ther, it is not dear aa to what "indiractr protection might iadude.
..... _. . .>. . ... ^gyjft^ ™
J , . ult to make eape-
. _-.y when environmental benefite are hard to determine and quantify but it ia alao
problematic in a food aaft^ stetuto. Hie billa language impliea that a benefit may
outwei^ the riaka aaaodated with atiy ris^ pastidde. It is not dear what criteria
should De applied to the other ris^ pestidde.
'Hie language <rf' H.R. 1627 also ezpanda current law, which requires the Adminis-
trator to comuder tiie "necessity for the production of an adequate, wholesome, and
economical food supply" and would require the Administrator to take "national and
regional efCects" into account It is not dear what problem this broader language in-
tenda to reaolve.
The Administration haa proposed esteblishment of a strictly health-based stand-
ard for food safe^, while providing for a transitional period during which benefits
could be considered in drcumstances involving significant benefits to consumers or
irnpacts on domestic (bod production.
We believe that a single health-based standard for food safe^ is critical to guiding
decjslon-malcers, as wul as providing credlbili^ to producers and assurance to con-
Burners, that the pestidde uaed in fbod producbon will protect health.
In abort, the American public should nave confidence in the safety of the food sup-
ply, but the kind of broad economic benefite language contained in H.R. 1627 is
problematic in a food safety stetuto
■dbyC-
16
Special Provisiotia for Infant* and Childrtn
H.R. 1627 includes some proviaionB in responae to the NAS report on Pesticidet
in tkt Diett of InftmU and Children, and in that respect ia an advance over the
House bill presented in the last Conpeaa. However, we believe that more ia naeded
to enaure odequato protection. H.R. 1627 provides meaaurea to ensure that needed
infomiation about uiildren's diets and pesticide residues are available. We would
like to see requirements that this informatian, along with information about auacep-
libility, be used in developing tolerances.
lite Administration's proposals for tolerance setting contained additional require-
menta directly Fsaponsive to recommendationa contained in the NAS report. E!PA
would be required to consider unique aapects of children's diets and potential aen-
aitivitiea to pesticide riaks. EPA would issue specific findings Hiat tolerances are
safo (br in&nts and children. We want to work with Congress to enact the necessary
aafeguarda.
Tolerance Procedurea
Under current law, a tolerance may be revoked through uae of a ftiU, formal evi-
dentiary hearing, which litigants have uaed successfully to delay action on pesticide
tolerances.
As drafted, H.R. 1627 not only retains dme-consuming hearing procedures but ac-
tually sets up inconsistent procedures, depending on whether the tolerance action
is initiated by EPA or an outside par^. For example, if objections are filed to a rule
ettabUthing new tolerances requested by a pesticide manufacturer, the tolerances
go into e^ct and the hearing takes place afterwards. However, if EPA initiates a
revocation proceeding, ottjections to the revocation entitle Qie objector to a hearing
prior to finalization of the revocation. This kind of inconmstency is a double stand-
ard that undercuts the basic premise of a puUic health/fbod safety protection law.
The Administration's proposal contained a straightforward notice and comment
procedure with Judicial review for petitions or actions on EPA's own initiative to es-
tablish, modiQ', or revoke tderances, which should be adequate to protect the inter-
este of producers, growers, and conaumera alike.
Consistent with the Administration'B proposed PIFRA amendments, time-consum-
ing hearing requiremente wmild be drq>ped.
Finally, H.R. 1627 is silent with reqiect to the review of existing tolerances. The
Administration, however, proposed to review existing tolerances to ensure that th^
meet the health-based standud. Further, the Administration also proposed that aU
pesticide applications be updated periodically to ensure that tolerances keep pace
with advances in adentific knowleoge. Without these provisions, there is no guaran-
tee that 16 years from now. Congress and the regulatory agencies will not face a
situation siimlar to the one we face today.
FFDCAfFIFRA 'Coordination'
As drafted, the coordination provisionB of H.R. 1627 could be read to have the
practical e^ect ofnwating all of (he safeguards, including those aimed at protecting
children, in the FFWiJA provisions of the bill with respect to existing tolerances. If
this ia not the intended result, these provisions need to be clarified.
KR. 1627 contains provisions designed to coordinate r^ulatery proceedings und^
the FIFRA and FPDCA, with EPA being required to take action first against a pes-
ticide's registration before finalizing a tolerance revocation. In terms of timing, this
makes good sense and is the practice generally followied by EPA currently. It should
be made clear, however, Qiat any "cocwdinatjon" provision for timing regulatory sc-
tions under the two atotutes does not affect the substantive provisions of FFOCA.
The language in H.R. 1627 states liiat even if EPA has determined thst s toler-
ance should be revoked under the FFDCA the Agen^ can be required to conduct
cancellation proceedings before the revocation becomes final. However, the stend-
ards for r^ist^tw pesticides under FIFRA can be less protective of consimiers sub-
ject to dietary risks than the standard for tolerance setting under the FFDCA be-
cause FlKKA allows for a broader rai^fe of considerations. Because H.R. 1627 pro-
vides thst FIFRA must be complied with first, we ore concerned that if the FIFRA
provisions are not the basis for proceeding against a pesticide, the Agency csnnot
move to revoke s tolerance or limit the pestidde's use.
Tlw Administration's proposals also addressed the issue of FIFRA/FFDCA coordi-
nation, and achieving greater consistency in statutory standards. Our position is
simple: if a tolerance is not safe, the registration must be addressed so that formers
following label instiuetionB do not run the risk of producing adulterated food crops.
DigilizcdbyGoOgle
EnfoTcemtnt AuthoritUs
H.R. 1627 would allow iwuiovce of & peatidde tolennc« even if a practical analyt-
ical method for detecting and measuring the peatidde reaidue were \mavailable' or
"not feanUe." In short, Qw bill doM not requira industij to identify analTtJcal roeth-
oda (br new peatiddea. Thua, the Ull would allow the aetting ofa bMt»net fin- a
peatidde that ia impoaaible to detect Tbaniim, EPA could approve a pesticide as
taSt, anUdpating low r«aldue levela. However, afnce FDA would have no wav of de-
tarmining whet&r reaidue levels were actually aa low as •zpected, we would have
no way <f knowiiw whether the fbod supply was actually saA.
In addition, H.R. 1^7 has no provisions comparable to the Administration's pro-
powers with respec* '' ---'-" ^"-' =
, „ jO remiire recalls, ei _ ,. _
levy dvil penalties for violations. The Aoministration believes that the peatidde
comparable b
poaala for enhanced FDA enforcement powers with respec ,
dues in fi>od, induding the authoriht to reouire recalls, embargo violative fiwds, and
atatutea need to be reformulated and that providing FDA with proper analytical
methoda and enforcement tools is a critical and essential part of that reform.
We believe that it makes no sense to reform tlie law if, because of a lack of ade-
quate enforcement authoritieB, the laws cannot be property enforced.
Uniformity /preemption of State Toleramx-aetting Authority
Aa you know, the Administration has taken no formal position on the specific
issue of pre-emption of state authority under FFDCA. H.R 1627 extends preemption
to warnings or other statements about the presence of peatidde residuea m food and
conaequently appears intended to over-ride state laws such as California's Propo-
sition 66 requirements.
International Standards
Aa a matter of policy, EPA takes the standards for pestidde reaidue levels set by
the international Codex Alimentarius Commission into account wbea re-evaluating
tolerances in connection with pestidde rereostration eligibility decisions. All toler-
ances must, however, continue to meet U.S. food safety standarda established under
the FFDCA. EPA also must comply with (^ligations regarding the use of inter-
national standarda under international trade agreements (North American Free
Trade Agreement and World Trade Organization's Samtaiy and Phytoeanitary
Ajpeement), but these agreements clearly allow EPA to set tolerances to achieve a
mgW level of protection for U.S. consumers than might be afforded by uae of the
Codex standarda.
H.R. 1627 could potentially alter existing practice, pladng a burden on EPA to
Juatl^ any departure from Codex levels. Perhaps unintentionallv, the bill as drafted
ooea even ftutner and could conceivably compel EPA to accept Codex levels that vio-
lata H.R. 1627'a com safM? standard, that tolerances must be "adequate to protect
public healtii,'' if beneflta outwei^ risks.
U.S. tolerances may differ bmn Codex standards because of unique pest centred
condiliona in (he U.S., different dietary patterns, or because of different health and
•afoty standards. U.S. ttderancea may therefore appropriately be hieher or lower
than Codax atandards, which do not take these factors into account. H.R. 1627, as
drafted, may result in registration and tolw«nce chanses that could inhibit effective
peat control In some growing reigns, and ipwre U.S. oietaiy patterns.
Conalstant with our trade agreement obugationa to conaider international stand-
anla in aetting peatidde reaidue tolerances, we believe it is appropriate for tolerance
pMittonan to addreas thia issue in their submissions to EPA, and to explain their
raaaona fl>r requesting tolerances that ma^ differ from Codex levels. EPA would then
eonaldwr and reapond to this issue when it publishes final tolerance regulations. We
4o not belleva that new legislation is needed to accomplish this.
UI. FIFSA PROVISIONS
While >oma of the FIFRA amendments in the current version of H.R. 1627 reflect
a^wntea over previous Iterations proposed eince 1989, others would encumber rath-
er tttan straiunllne regulatory processes. Others may make achievement of public
^«^th and environmental goals more difficult, compared to current law.
>4M^ly, the eonoatiatton procedures in H.R. 1627 combine the time-consuming
<MMm* «f Nrth rule-making and formal a<]iudicatory hearing procedures. While
MMiM^tmg alrict Una llmiUtiona for stws in uie r^ulatoiy process, the bill's provi-
«iMM niMMttaRSDUabr make adherence to these deadlines Impossible. For exai '
MWrt Www IMtli«Muings to 20 d^ ere likely to prove unworkable in practice,
sHM* liwiMn^ haaitnc preaantationa or cross-examination may be grounda for over
*IMMC « «MW«a»tten nila.
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Wefuppartdusoalof ■tTiMBiliiiingi«gulatoi7prDC*diiraB. But (ha bill u draftad
■Impljr doM not KiiisTC that goal, mnd In &ct may fUither prolong cancellatiaii pro-
cacainp. Both &nnen and tu puUic nitSar whion peatidM rlik ooncenu remain
unrMoIvMl toot long pcoioda oftijiM.
ILR. 1627 u eumntly draftMl doaa not adiieve ita atated atraamlining objectivei.
A ■trai^tfbrward notice and coounant proceduM a> used under other regulatory
atatutea, as propoaed b; the Adminiatration, would be a mora appropriate wur U>
reaol>« the klDda of adentific iaauea likely to ariae in a cancellation proceeding. Such
a procedure would of courae allow fin- promptjudicdal review of EPA'sdedalona. Un-
law thaae cancellation proviaions in H.R. 1627 are modified mibatantiaUy, we would
prrin awlgtiiiy Uw.
"Burden of PnoT
A provision contained in H.R. 1627'i "oonfimning amendments" appears to shift
the burden of proof of a pesticide's safety from the pesticide manu&cbirerAvgistrant
to EPA. Lomr-atanding regulation (adopted after notice and ccnnmant), case law and
1 the responsibility for showing that a pestidda meats the stand-
ion on die proponent of ragiatratiDn. This ia simply commcm sense.
Tlie public should not bear the risk of exposure to questionable peatiddes; it is up
to tliosa «4io maiket pesticid e s to demonstrate that safe^ standarda are mat.
Other "conforming amendments" as well as the detslled cancellation provisions
deaerve careflil scrutiny to ensure that existtng protections sre not eompromiaed.
For example, one provision could complicate ana poaaibly attenuate the effectiveneaa
of EPA's asi sting suthority to requira remstrsnts to submit data about the health
and anvlronmantal affects of pesticides and suspend registrations n4uch are not sup-
pOTted by timely and adequate data. Any change in existing law should be sup-
ported by clear evidence that there is a problem requiring coirection in the statute,
and that our ability to addreas health and environmental concerns would not be
compromised.
Minor Vaea
The AdminiBtration supparta loduaion of proviaionB to encourage the registration
and maintenance of pestuddea fbr important "minor uaes," providM that certain cri-
teria are met to Misure that these uses are in the public interest maintain effoctive
means of pest control and do not raise health or environmental risk concerns. If risk
questions arise, EPA must be able to act quickly. H.R. 1627 meets this requirement
IGnor use pesticides whose primary flinction is to control public health problems
(e.g. vectorJxmw disaaass) shwld also be covered bv minor use incentives, provided
that data are sufBcienl In aome caaaa, the economic incentivea fbr developing such
data may be lacking, and it ia fiir this reaaon that the Administration's proposals
in the last Congress induded proviaions for consultation with the Department of
Health and Human Services/Public Health Service and support for neceasary data
development. Such a mogram would be analogous to USDA\ IR-1 protP'sm for agri-
cultural minor uaea. The Subcmnmittee may wish to incorporate such a program
into H.R. 162Ts current minor use provisions.
Ftf
tiM pointed out in previous testimony by this Administration as well as by my
predecessors in previous Administrations, EPA needs a reliable resource baae in
order to accomplish its ststuton mandate to cata^Mit reredstration of otder pee-
tiddea on an aecalerated basis. HJt. 1627 contslns no PIFRA fee pr ' '
port this work. Should authorteatifm for exialing fees be allowed to expire in 1997,
the result would be disruption, significant decnases in EPA's scientific stsfT, de-
layed dedBion-niaking, and loas of confldenca in the pestidde regulatory system.
As Cu as growers and the public are concerned, it is never a good anawer for EPA
to say that we have not been able to assess a pestldde'a safety based on current
adentific standards. When questions arise, public confidence can be maintained only
if EPA can respond that it has completed its assessment end found the pestidde
use to be safe.
Updating Rigulatory Pmxdurta
While H.R 1627 addresses a number of critical issues, there are other important
changes that would make our regulatory ftamework more responsive to sdentific ad-
vaneea and provide the Agency with flexible tools to achieve public health and envi-
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eondititnu of ngiKtratioii and to maintain the avallabflity of peatiddes under eon-
trolM^conditions to praaarve efibctivenaas in IPM pnsrama.
FiFRA'a enforcement and penalty proviiiona are outdated and badly need upgrad-
wnh the nature and aeveri^ oL . .,. „„„
Finally, the AdminiBtastion propoaed changea to FIFRA to encouraee sound pes-
ticide product stewardship throufliout the worid, reduce the posdbLU^ that pee-
ticidea exported from the U.S. would return as unsafe residues on fbod impcoled mto
tiiis counb^, and enhance the abilit? of pesticide-imporling countries to make In-
fonned decuions on potentially hazardoua pesticides that may be shipped to them.
We urge Congresa to seriously consider such reforms as it attempts to craft com-
prehensive pratidde legialation.
tV. DATA COLI^CnON
While we appreciate H.R. 1627's attempt to place statutory priority on Integrated
Peat Management (IPM) approaches, better putidde use data, and improved infor-
mation on actual pesticide residues in foods (eapedally foods consumed by infanta
and diildren}, we oo not believe that the current Dili goes far enou^ in this respect
In particular, there are no provisionB to encourage the development and regiatraticKi
of roduced-riik. safer or bluogical pestiddes, or to provide resources fto* unproved
data collection adivities. The Preddenfs budget has consistently requested the
funding required to cany out the taaks mandated in HR 1627 such as IPM pro-
grams, IR-4 pesticide uee survey*, and dietary intake studies. Unfbrtunately, Con-
greas has not provided the neceaaary funds, mthout appropriations commensurate
to the tasks presented in this bill, very little of the legislation's intent can be acctsn-
plished.
V, CONCLUSION
It is time for the Administration and Congress to woric together for common sense
refbrm of our pesticide laws, to reach agreement on legislation that will protect pub-
lic health and the environment, maintam and enhance public confidence in the safe-
ty of the fbod supply, and facilitate the development and adoption of safer, eSbctive
peat control techndodes.
Any new pestidde l^slation should establish a single, health-based standard for
pestidde residues in food. It should also ensure protection of our children from pes-
tidde risks consistent with the NAS report and provide for fees to support comple-
tion of rereglatration. Together, we need to w<»n( out and resolve our difierences,
make changes where necessary, and focus on these common goals.
Thank you again for the op^rtuni^ to jdn you this morning. We look forward
to working with this Subcommittee and others in Congress to enact meaningful re-
forms. Change is long overdue.
Mr. BlLIRAKIS. Thank you, Mr. Elworth.
Ill start the questioning, and, as I've indicated at the outset, I'm
going to hold aUictly to the 5-minute rule in the interests of time.
Dr. Goldman, EPA does consider health effects other than cancer
in making tolerance decisions right now, do they not?
Ms. Goldman. Yes, we do.
Mr. BlLIRAKIS. All right. I'd just like to run down the checklist
of issues that the EPA considers in registering the use of a specific
gestidde on a specific food to make sure we all understand^ what
ealth effects the agencv currently examines. Does the agency re-
quire the submission of data concerning a pesticide's acute oral,
dermal and inhalation effects, reproductive ^tem effects, chronic
effects from dietary exposure, oncogenicity efrects, mutagenesis ef-
fects, fetal effects, delayed neurological effects, plant and animal
metabolism effects?
Ms. Goldman. All those are required to register a pesticide un-
less a pesticide fits in certain categories. We have some pesticides
for which we do not require all those data that we have issued PR
notices on, but for the ones that we Uiink are likely to be toxic, yes,
we require all those data.
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19
Mr. BiLiRAKlS. All rieht. Given the wide rfinge of health effects
that the agency currently considers, I'm not sure that I understand
EPA's concern that the negligible risk standard in this bill, H.R.
1627, is unclear with respect to noncancer risks. Are you saying
that under the language of H.R. 1627, the agency would somehow
no longer be able to consider all the factors we just went through
or would not be able to consider new factors?
Ms. Goldman. Let me sum up what the concern is. The term
"negligible risk" was developed in order to deal with a problem that
we nave when we regulate carcinoeens where we assume there is
not a threshold, we assume that there is no level at which there
is no effect. In toxicology for most health effects we have something
that we call a no observed adverse effect level. That is a level below
which nothing happens to the animals who are tested. Above that
level there are adverse effects.
For some — ^it used to be all, but now it is still most — carcinogens,
we assume there is no such thing as a threshold, and therefore we
can't guarantee a no effect level. Instead, what we go for is a neg-
ligible risk which is that the risk is so small that m essence it is
nejriigible, but theoretically there is still some risk there.
The standard that we proposed last year of a reasonable cer-
tainty of no harm means for tne noncancer risks that we are below
that threshold of effect, and for cancer we have a negligible risk.
That has a clear legal interpretation, and we just don't understand
what the le^ interpretation of neellgible rie^ would be for those
noncancer enects, those effects for which there is a threshold.
Mr. Bujrakis. As I understand it, you get to set that, don't you?
Isnt that part of your responsibility?
Ms. Goldman, well, I think that part of what we need to engage
in as a part of working out this legislation is a dialog, because
what wiU happien is that in court, if this legislation were enacted,
they would want to know what was the legal intent of Congress,
what does Congress intend.
I think part of why we are raising the issue and we want to dis-
cuss this issue of the standard with you is to understand what the
intent of Congress would be in est^lishing a standard of a neg-
ligible risk for a noncarcinogen.
Mr. BnjRAKls. I would hope that in the interests of protecting
the public health which we are all interested in — both Republicans
and Democrats — that that is something that can be worked out.
But, again, it seems that the responsibility basically is yours and
we shouldn't be getting away from that.
Tm concerned — end Mr. Bilbray, among others, accented this —
that the administration doesn't seem to want the appropriate flexi-
bility, for the agency to take advantage of the best science, which
is the goal of Hll. 1627.
The administrator testified before this subcommittee pre-
viously — and I quote, "that in order to ensure that future EPA deci-
sions and risk assessments will reflect the best of evolving science,
the statute itself should not prescribe in detail the risk assessment
assumptions and methodology that the agency should use in evalu-
ating whether a pesticide meets the safe^ standard." The question
is, how does H.R 1627 not reflect this philosophy? I think it is in-
tended to, and isn't EPA better qualified to make scientific deter-
DigilizcdbyGoOgle
20
miniit vwf than the Ctngies^ So if we get too definitiTe we cer-
tainly are makiog those acientific detominatioiu in this ivory
tower here. I would aak you in the intossta (rf time to withhold the
answo- to thia question, but possibly before we finiah up you might
get to it.
Ma. GOLOHAN. I can actuaUy do it very briefly.
Mr. BiURAios. All ri^t.
Ha. GoLDHAN. We do appreciate that HJL 1627 does not pre-
acribe in detail how we should do the risk assessment procedures,
and we are in agreement with the chairman that legislation should
not do that so toat our hands are not tied in the fiture when the
science changes.
Mr. BlURAlos. All ri^t l^iank you.
Mr. Waxman.
Mr. Waxman. Thank yon very mudi. Mr. Chairman.
I think we ou^t to be concerned ^lout basing our decisions on
sound scirace, and what worries me about this l^islation, which
I thhik is quite extreme, is, it is not baaed on sound science.
We naked the Natitmal Academy of Sciences, the premier sci-
entific institution in this country, to look at the problems of pes-
ticides in children, and they have given us recommendations, and
it is my contention that those recommendations are absolutely ig-
nored in this l^pslation.
Mr. Schults, I woold like to aak you this question about H.R.
1627 and its relationship to the NAS report on pesticides in the
diets of infants and chiloren. On page 1 of the NAS report it says
'^lerances omstitute the sin{^ roost important mechanism by
which EPA limits levels of pesticide residues in food. Unfortu-
nately, under thia bill tolerances would no longer appear to be the
most important medianism for protecting the rood supply. Instead,
we vrould have a &ir weakor standard m FIFRA which would ap-
pear to take precedence." And I would like to direct your attention
to the harmonizatioo, so called, provision on page 80 of tiie bill
which s^s that the administration must act first under FIFRA,
not the tolerance provisions of the Federal Food, Drug, and Cos-
metic Act. Are these provisions consistent with the Academy rec-
ommendation that tolerances serve as the most important mecha-
nism for limiting pesticides in food?
Mr. SCHULIZ. Mr. Waxman, we don't believe they are, and we
don't believe they are consistent with the current law either. The
bill seems to say that before you could take a pestidde off the mar-
ket you would nave to go tnroueb the entire FIFRA process and
find that it doesn't meet the weaker FIFRA standards, so it seems
to do exactly the opposite.
Mr. Waxman. On pages 8 and 9 of the academy report it says
"Children should be aUe to eat a healthful diet containii^ le^al
residues without encroaching on safety margins." Do you think
H.R 1627 achieves this goal?
Mr. ScHULTZ. It mentions children, but it doesn't seem to require
EPA to do anything specific, make specific findings or do the unds
of thin^ that the report envisioned.
Mr. WAXMAN. Dr. Goldman, do you agree with Mr. Schultz on
this fundamental point?
DigilizcdbyGOOglc
21
Ms. Goldman. Yes, we think that it could be strengthened in
that reeard, and, as I said before, we are also concerned not only
about the coordination but also about the very broad benefits lan-
guage which doesn't set a specific limit on uie kinds of benefits
that would be considered in allowing more than a negligible risk.
Mr. Waxman. The NAS also made a number of specific rec-
ommendations, one of which was on page 11 of the report, and it
says, "All exposures to pesticides, dietary and nondietary, need to
be considered when evaluating the potential risks to infants and
children." Mr. Schultz, does H7R. 1627 require EPA to consider all
exposures to pesticides as NAS recommended?
Mr. Schultz. It doesn't appear to require that or anything very
specific.
Mr. Waxman. On page 11 the NAS also recommends that EPA
consider synergistic ^ects of pesticides with common toxic effects.
Dr. Goldman, does H.R. 1627 require you at EPA to consider these
effects?
Ms. Goldman. There is no specific requirement in that regard.
Mr. Waxi^ian. Dr. Goldman, H.R. 1627 treats the inert ingredi-
ents that make up over 90 percent of most pestiddes. As I under-
stand it, these inert ingredients are regulated but they could be es-
sentially deregulated under H.R. 1627. Could you comment on this?
Ms. Goldman. We think that it is very important that we assess
the inerts as well as the active ingredients in pesticidea. Some of
the inert ingredients, although they may not be active against the
pest that is Deing controlled, may have activity in terms of biologi-
cal activity for humans.
Mr. Waxhan. Why is that?
Ms. Goldman. Basically, the definition of inert just identifies
whetiber it is targeted against either the insect or the weed or the
other pests that the pesticide is trying to control. The definition of
an inert has nothing to do with the tocology for humans, and we
do need to look at toxicology for humans for any product that is
going to be on food.
Mr. Waxman. Are we talking about product ingredients like ben-
zene or formaldehyde that might be an inert ingredient?
Ms. Goldman. In the past there have been ingredients like that,
and there are still inert ingredients that we need to look at today.
Mr. Waxhan. And would H.R. 1627 let these dangerous chemi-
cals back into pesticides as so-called inert ingredients?
Ms. Goldman. We think that H.R. 1627 would tend to relax the
standards and make it more difficult for us to control the levels of
the inert ingredients.
Mr. Waxman. Mr. Chairman, let's adopt I^slation based on
sound science and take to heart the recommendations of NAS.
I yield back my time.
Ku:. BnJRAKlS. The gentleman's time has expired.
Mr. Bliley.
Mr. Bliley. Thank you.
Ma. Goldman, I'm confused by EPA characterization of the risk
standard in H.R. 1627. The bill establishes a single negli^ble risk
standard for tolerances for pesticide residues in both agricultural
conunoditieB and processed foods. It states that a tolerance m^ not
be established that is at a higher level than one which the adminis-
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trator determines is adequate to protect the public health. The bill
further states that the phrase "adequate to protect the public
health" means that the risk cannot be more than neRligible. The
bill further requires the EPA administrator to set forth by regula-
tion the factors and methods used to determine negligible risk.
The administration's testimony expresses concerns that the bill
is not specific in defining negligible risk, yet EPA had in place a
negligible risk policy defined as one in a million risk that it went
to great lengths to defend in court. Indeed, the current EPA admin-
istrator testified before this subcommittee last Congress and stated
that in terms of carcinogens the administration's recommended
standard, reasonable certainty of no harm, meant that the dietary
risk is negligible. Further, the administrator stated that the agency
would implement this n«[ligible risk standard with a risk calcula-
tion of one in a million. What would prevent the agency from im-
plementing the negligible risk standard for carcinogens as a risk
calculation of one in a million?
Ms. Goldman. I think that in terms of the way the statute has
been drafted, clearly for a carcinogen we would probably do the
same thing that we do today, and that is, today we would use the
models that we use and probably interpret the risk that we are
targeting as somewhere around one in a million. But the problem
is that the issue is for noncancer risks where we don't use those
kinds of models and extrapolations. Instead, for those risks there
is actually a threshold, there is actually a dose below which you
don't have an effect, and that is where I think we need to have a
dialog with the authors to understand how we would interpret the
term 'Negligible risk" as a standard when it is not a carcinogen.
Clearly if it is a carcinogen would do as we do today, and, as we
argued in court, we should do, but the real question is for
noncancer risks, for neurotoxicity, birth defects, miscarriages, how
we would interpret a negligible risk standard.
Mr. BuLEY. In terms of benefits, Ms. Goldman, does EPA make
the assumption that any loss of production in the U.S. can be made
up by imports from other countries?
Ms. Goldman. No, we do not. When we do our FIFRA registra-
tion activities we do not look at that issue of imports. Under
FIFRA, which, as you know, is a risk-benefit balancing law, we
look at the availability of alternatives for the farmers and what we
think they are going to be — what we project to be the costs of the
decision as opposed to the benefits of the decision.
Now in terms of FFDCA today in terms of setting tolerances, we
do not use benefits considerations. We tend to set tolerances based
on health concerns alone, and we think that that is generally an
appropriate way to do this.
It has been pointed out to us that there may be times that there
are health considerations theoretically — ^that there are direct
health benefits to consumers from the use of a pesticide on food,
and we think that that is a benefit to the consumer that we ought
to be willing to think about. But in terms of other kinds of benefits,
I think we nave to be very careful about weighing benefits to one
group of people in exchange for risks to another jnroup, and that is
why, when we see the very broad language in H.R. 1627, we are
DigilizcdbyGoOglL^
auite concerned because it would be a departure from current prac-
ce.
Mr. Bliley. Tliank you.
Thank you, Mr. Chairman.
Mr. BnJRAKIS. I thank the gentleman.
Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman.
Dr. Goldman, do you believe that this bill gives you sufficient
flexibility to develop standards that will respond to the special
needs of children and infants?
Ms. Goldman. I think that in terms of actually using data on
kids' risks that we would be able to do that. I think the greatest
concern about children is in two areas: One, how the negligiole risk
standard would be interpreted, say, in a court of law, £ina I think
that is something we are going to work out with the committee; I
feel confident that we can work out what the standard should be.
And, two, how the benefits language would be construed in terms
of allowing economic benefits to outweigh protections for children,
and that is an area about which we have a lot of concern and that
we want to work with Congress on.
Mr. Towns. Thank you.
Would you agree that once a Federal standard is established by
EPA that we should not have States coming in with warning sij^ns
and requirements of other measures that prohibit the sale of mod
that EPA has established as safe through a national science-based
standard?
Ms. Goldman. We believe that there is a balancing here that
needs to be done, that States have the obligation and the right to
protect their own citizens, but that we also need to have a national
food safety program that protects all Americans.
Tm aware that there are issues that are raised by H.R. 1627 in
terms of the ability of States to set tolerances, and we have been
having discussions with some of the Stetes about this. Some of
them feel that if they don't have that ability, that that removes
from them some of their ability to either protect people in their
own States or to even leverage the Federal Government to set tol-
erances when they feel that the Federal tolerances are not strin-
gent enough. I think this is something that we need to work out
with the States so that we end up with the appropriate balance of
responsibility between the Federal and Stete government in this
area.
Mr. Towns. I think about the production and marketing, and
also I think about the fact that there is a history of some States
sort of being selfish for reasons other than health or safety. What
are your views on that? I mean I'm sure you have experienced it
somewhere along the line.
Ms. Goldman. Well, the reality today is that although States are
allowed to set tolerances if they want to, we don't have any situa-
tion where there are separate tolerances for Stetes, and so al-
though I think it could be complicated if the States were £(oing off
creating their own standards, they haven't actualhr been doing that
so we havent seen misbehavior by the States, if^you want to put
it that way, in this area at all. In fact, we have found that the
States are extremely reluctant to set their own tolerances.
DigilizcdbyGoOgle
24
Mr. Towns. The point Pm makine is that I've seen it in other
areas and I think uiat we have to be concerned and sensitive to
the fact that it could happen in this particular area as well, and
I think that is something that you, I'm certain, would he very sen-
sitive to as well.
Ms. Goldman. Yes. I would juat say that the rights way to work
this out would be to include the States in develoj^in^ a solution
that prc^rly recognizes their authorities and their junsdictJons in
terms of protecting their citizenry.
Mr. Towns. Right.
Even though our committee lacks jurisdiction over these provi-
sions of the bill, if we did not enact pesticide reform this vear what
economic impact do you believe recent court decisions will have on
agriculture, particularly, I guess, in the minor crops?
Ms. Goldman. The impact is goin^ to be on the use of apprraci-
mately 35 pesticides, and it is approximately 80 pesticide food com-
binations that currently have tolerances which, as a result of the
court ruling, will possibly not exist in the future. What we are
doing is — you know, the court ruling from 2 years ago is systemati-
cally reviewing these, making sure that they are covered under
Delaney and making sure that indeed we do need to revoke them,
and then we have promised the court that we will in a very system-
atic way cany out those actions. This will have an economic impact
on certain crops, certmnlv on certain pesticide producers as well.
What we are trying to do to mitigate that is to do this in as pre-
dictable a way eis possible. We have signaled every step of the w^
what we are going to do and when we are going to do it to allow
people to make any adjustments that need to be made.
Mr. Towns. Mr. Chairman, I see my time has expired, and I
yield back.
I think that what I gather from your statement is you are saying
that this wagon is broken and it needs to be fixed.
Ms. Goldman. We said that last year with the reform bill that
we sent forward. We feel that there needs to be fundamental re-
form in the food safety laws, both the food law and FIFRA.
Mr. Towns. Thank you.
Mr. Bilirakis. I thank the gentleman.
Mr. Whitfield.
Mr. Whitfield. Thank you, Mr. Chairman.
Ms. Goldman, I wanted to ask you a question relating to your
1992 U.S. Court of Appeals decision out in California wmch ruled
illegal the de minimis rule relating to section 409, but it didn't say
anything about section 408 on the raw commodities side. Is that be-
cause the Delaney Clause is not there on that. Why, then did the
EPA enter into a consent degree voluntarily to expend scarce funds
and resources defending the revocation of these 80 or so pesticides
that you are going to require not to be used any more? Why did
you ail enter into a consent decree on that when you probably could
have done it in another way?
Ms. Goldman. I think your question really has two parts, and
m start out with the part of why did we enter into in a consent
decree. We did not want to end up in a situation, as the agency
often has, where the court is managing our administrative proc-
esses, and we felt that a consent decree would be far preferable to
DigilizcdbyGoOgle
losing and then ending up having a process micromanaged by the
court — ^what has happened to the EPA in many, many instances in
the past, as I'm sure you are well aware.
In terms of the issue of 409*s, the tolerances on processed foods,
versus the 408's, which are the tolerances on fresh miits and vege-
tables, what we agreed to do was to, by some date certain, articu-
late our poUcv on those, on coordination of those, and then act ap-
propriately after we did that.
Iiie issue — and it is really an issue between EPA and FDA and
USDA is that the legal use of a pesticide should result in legal
food, and many have contended that foods could be segregated, that
there could be treatment of foods and some of those msh fruits
and vegetables can go into the fresh fruit and vegetable market,
others go into the processing market, and thus not nave a problem
with the 408*B as a result of Delaney, but that has consequences
for the farmers in terms of the actum ability to guarantee that. It
also has consequences for the FDA in terms of being able to enforce
that
So that is an issue that we have to work on across the Govern-
ment in t^ins of deciding what our policy is and how we will han-
dle that question. But ft is a veiy serious question, because it
would not De right for the farmers if they follow the rules and use
pesticides as legally allowed and then have the food that is pro-
duced end up being illegal food. That would not be right for the
fanners.
Mr. Whitfield. But you are actually going to eliminate the use
of about 80 pesticides which your agency has basically said are
safe, and have been used in the past. Now you all are voluntarily
agreeing to a consent decree that is going to require that these not
be used.
Ms. Goldman. We are not eliminating 80 pesticides from the
market. They are 80 individual uses, use of an individual pesticide
on an individual commodity that are at issue, and we have not
made final decisions on these as well. What we have pledged to do
is to make the decisions, and, in addition to that, we nave pledged
to look at other data that we have where we haven't necessarily
made a determination that a 409 would be needed and examine
those as well.
Mr. Whitfield. Back in 1992 I know some of the food industry
groups filed a petition urging EPA to rescind its coordination and
concentration policies. That has been pending now for about 3
yefu*8, and yet you all have not taken any action. Why would it be
taking so long to address that issue?
Ms. Goldman. We felt as an administration that our first prior-
ity was one of putting together reform legislation and actually try-
ing to change the law.
What the court told us is that we couldn't change the law by tak-
ing administrative action, that the only way that the law could be
clunged is if Congress changed the law, and so we felt that our
highest priority would be to put together some reform legislation
that would change the law and that would then obviate tne need
for responding to that petition. Because we were not successful last
year in doing so, we are proceeding with the response to the peti-
tion, and we did promise the court that we would issue a response
DigilizcdbyGoOgle
<m a schedule along with the schedule for doing revocations. Frank-
ly, we are still hopeful that we will see reibnn legislation.
Mr. BiIiiRAKIS. l^e gentleman's time has ezpirad.
I thank the gentlenun.
Mr. Brown.
Mr. Brown. Thank you, Mr. Chainnan.
Mr. Schultz, I want to ask about the role overall of FDA in pes-
ticide regulation. Run throu^ this very, very complicated issue, if
you would, and it was touc&d on a little bit by Mr. Towns' ques-
tion on the economic impact — but run through, if you would, more
precisely what Delaney means, the impact of Delaney as it stands
now, and what H.R. 1627 does in replacing Delaney and sort of de-
lineate that if you would.
Mi. Schultz. Okay, and let me make clear, I think we are just
talking about pesticides.
Mr. Brown. Yes.
Mr. EICHULTZ. The Delaney Clause applies to food additives in
color additives and smimal drugs, and there's a lot of confusion
about that.
But as to pesticides, the Delaney Clause in the food additive pro-
vision that we are talking about, in the way the law works, there
is a separate section for pesticides. Section 408. When pesticides
are on a fresh crop or raw crop the Delaney Clause does not apply.
When the apple is made into apple sauce, so now it is in processed
food, and when the pesticide actually concentrates so it is at a
higher level, there is more pesticide per product than in the apple.
At this time the pesticide eul of a sudden becomes a food additive,
and now it is regulated under 409, and now EPA has to set a sepa-
rate tolerance. When it is a food additive the Delaney Clause ap-
plies.
You are looking at me like a lot of people at this point as if to
say, "why do we have all these inconsistent standards?" I think one
thing that this bill does that makes a whole lot of sense is, what-
ever the standard is — we can argue about that — it ought to be the
same in the apple sauce as in the apple.
Mr. Brown. And that is what the Academy of Sciences suggested
in the report correct?
Mr. Schultz. Yes, and they said that the tolerance system, the
health-based standard ought to be the one that drives food sE^ety.
Mr. Brown. Thank you, Mr. Chairman.
Mr. BnjRAKls. I thank the gentleman.
Mr. Bilbray.
Mr. Bilbray. No questions, Mr. Chairman.
Mr. BnjRAKls. Mrs. Lincoln.
Mrs. Lincoln. Thank you, Mr. Chairman, and thanks for holding
the hearing.
I would like to ask unanimous consent to have an opening state-
ment in the record.
Mr. BlURAKlS. Without objection.
Mrs. Lincoln. Thank you, sir.
Dr. Goldman, in regara to, I guess, Mr. Wazman's questions ear-
lier in terms of what you are required to do and your answers
there, is there anything here that precludes you from doing that?
byG(^)gIe
27
Ms. Goldman. No. Hie only worrisome language in terms of pre-
cluding us from using any health-based data for a standard is the
benefits language in the bill, and that is an area where I think we
need to have much more discussion with Congress, because as writ-
ten it is very broadly construed.
Mrs. Lincoln. Yes. In the SecMon 301 under Title III it seems
to me that you are required or certainly that there is nothing there
that precludes you from being involved and certainly doing the
testing and the research or looking into the issues of what Mr.
Waxman brought up.
Ms. Goldman. Right. The issue is whether other considerations
would supersede considerations such as protecting children and
other health issues.
Mrs. Lincx>ln. But again, you would b<e in charge of that, as Mr.
Bilirakis pointed out.
Ms. Goldman. You have to keep in mind that when you are ad-
ministering these statutes that one of the very important consider-
ations is, what was the intent of Congress when the bill was writ-
ten, and if we have challenges to our decisions it is very helpful
to point to either very clear statutory language about intent or to
have other discussions that axe on record t£at support our interpre-
tations of the statute. That is why we want to oe very careful in
discussing these issues with Congress to make sure that we all
have a complete understanding and that it is not simply up to the
discretion of the agency later on.
Mrs. Lincoln. You have stated in the testimony in the past and
certainly in correspondence with me in regard to the Detaney
C3ause that it should be modernized and sbeamlined — ^you have
eocpressed that here today — ^to reflect a single and uniform public
health standard. Clearly that is the objective of all of us here, to
get broad-based policy goals there. I guess the problem really ties
m the definition as a single uniform public health standard and
prior to the Lea v. Reilly, which I guess was the years 1988 until
1992 — is that correct? — ^you defined negligible risk, correct?
Ms. Goldman. For a carcinogen we have a deax definition of
what we mean by a negligible risk, and we think we would know
what to do. It is for the case of noncarcinogen risks such as birth
defects, 8[>ontaneous abortions, neurotoxicity, that we are not clear
«4iat that means, and that is where
Mrs. Lincoln. In reference to what Mr. Bliley was mentioning,
the chairman was bringing out that you have clearly defined or you
have done that in previous years — correct? — ^in terms of negligible
risk for cardnc^ens.
Ms. Goldman. For a carcinogen, yes, I think we have complete
clarity about what that means.
Mrs. Lincoln. So you don't have any problem with that, it would
be certainly with the noncarcinogen.
Ms. Goldman. Right, and that is whv last year we proposed a
standard. What we said was a standard of a reasonable certaintv
of no harm, which for a carcinogen would mean a negligible risK
standard, and we felt that that broader language woiud cover us
for all public health concerns.
Mrs. Lincoln. So you just want to put a "one size fits all" as op-
posed to really dealing with the differences?
DigilizcdbyGoOgle
Ms. Goldman. We either need language that is broad enough
that it matches with everybody's current understandii e of what we
mean or we need to have it on the record or in the LUI that what
is meant by negligible risk for a noncarcinogen is in essence what
we would do in current practice to protect public health. We are
not looking for channng current practice, we just want to make
sure that the standard wouldn't be interpreted toe wrong way.
Mrs. Lincoln. Prior to 1992 though you did develop the defini-
tion in terms of negligible risk for a carcinogen?
Ms. Goldman. For a carcinogen, yes, and so has FDA. I think
there is a lot of history here in terms of case law and administra-
tive practice that tells us what to do with the concept of n^ligible
risk for a carcinogen.
Mrs. Lincoln. But there is nothing — going back to Mr. Wax-
man's questions, there is nothing that precludes you from' dealing
with those noncarcinogens in terms of
Ms. Goldman. It wouldn't preclude us, except I think if it is not
clear what Congress's intent is in this matter, that our decisions
could be subject to challenge and that that could be very trouble-
some. If you trace back the history of the term ''negligible," what
it really means is that theoretically there are a few cases that
might occur, and we certainly don't want to allow a few birth de-
fects or miscarriages or neurotoxicity cases &om legal use of a pes-
ticide on food because there is a threshold for those effects. We can
do much better than that.
Mrs. Lincoln. I was particularly pleased to see in this legislation
we are reviewing today the inclusion of data collection regarding
the diets of infants and children. I know that last year's Dill did
not have that in it, and I had certainly considered it a weakness,
and that you have indicated some concerns with this provision
Mr. BnjRAKls. The gentlelad/s time has expired.
Ms. Goldman. I should just say we are very supportive of the
provision, and we would just want to go a little further and not
only collect the data but nave a requirement that we use it. Cer-
tainly if we have the data we will use it.
Mr. BnJRAKlS. Thank you.
Mr. Burr.
Mr. Burr. Iliank you, Mr. Chairman.
Dr. Goldman, let mejust read a couple of quotes to you from Ad-
ministrator Browner. Tais was in the New York Times, 2 February
1993. "We have gotten to the point whero we have to say we know
a lot more about these chemicals than we did 36 years ago when
the delay Delaney Clause was passed." And in Februaiv 1993 also
in Time magazine, "Hiere are scientific anachronisms tnat get cre-
ated any time you have a SO-plus-yearnsld environmental regula-
tion. It is time to revisit Delaney with the knowledge we nave
now".
Now if I understand your testimony, you want to see revisions
to Delaney but you don't like H.R. 1627. Is that accurate?
Ms. Goldman. What we are trying to do is to point to areas in
H.R. 1627 where we think we need to work with Congress on areas
that we think are not clear or to identify areas that would make
the law worse than existing law as is the case of some of the
FIFRA provisions.
,yGoO'
.gle
Mr. Burr. What will happen under existing law if there is no
change?
Ms. Goldman. Under existing law if there is no change, one, we
will have to continue carrying out the Delaney Clause, and I should
point out it has now been 37 years since Delaney has been enacted
and we have never had an administration that has taken the
Delaney Clause literally for pesticides. Thirty-seven years — if you
think about that, how many laws there are in that kind of state?
Two, we will continue to nave a situation where there are three
standards for pesticides on foods, which we think is a conAising sit-
uation.
Three, we will continue to have FIFRA provisions that are cum-
bersome and need to be streamlined.
We would like to see a reform bill that would address all of these
concerns. We feel that this particular bill would not streamline
FIFRA, it would actudly make FIFRA even more complicated and
cumbersome. We cannot support that. We — as well as other past
ad^^iistrations — ^have come here to Congress to try to improve
FIFRA. We remain committed to that.
Finally, the bill does not address the need for renewing rereg-
istration fees and bringing up to date the out-of-date pesticides
that remain on the market as one of the most important things
that we are doing. We have dealt with 100 out of the 400 that need
to be brought up to date. Hat is still 300 more. We have not com-
pleted that job.
Mr. Burr. Based upon the court decisions, is there an economic
impact that will hit the American consumer and manufacturing
base if Delaney is not changed?
Ms. Goldman. We have looked at economic impacts, and we do
not prqject impacts to the consumer, but we do project impacts both
to some s^ments of the agricultural community and to some seg-
ments of the pesticide production industry.
Mr. Burr. Well, certainly if there is a cost in the chain I think
the consumer will bear some of that.
I was interested because you stated in our opening remarks that
economic consideration is not appropriate in H.R. 1627. Let me
read you one other quote from a paper, "The Delaney Clause is an
outdated approach for protecting consumers from pesticide resi-
dues. Clearly the loss of selected pesticide uses may affect the price
or seasonal availability of particular commodities. Theoretically, a
zero risk approach to cancer for these pesticides could lead to use
of alternative pesticides with more net risk but no cancer risk.
Iliese costs to socieW buy little in the way of additional public
h^th protection." Lynn Goldman, EPA November 25, 1994,
Science magazine.
Ms. Goldman. I was going to say, I could have written that, but
I guess I did.
Mr. Burr. You did.
So I would ask you, apparently there is an economic consider-
ation that we all must make, because I think that your statement
there alluded to the fact that there was an impact.
Ms. Goldman. Right, and I think that we have supported mod-
ernizing the food safety standard, but we would not support the
kind of broad benefits language that we see in the current version
22-264 -96-2
DigilizcdbyGoOgle
so
of H.R. 1627. When I say that the Delaney approach doesn't make
Bense ia not the same as saying that we would therefore sup[>ort
this other approach.
Mr. BuBR. Okay. Let me say that there was also an Executive
Order 12666 which directs Federal agencies to consider costs and
benefits of available regulatory alternatives.
Mr. BiLiRAKis. The gentleman's time has expired, if you could
finish it up.
Mr. Burr. If I could wrap it up, how does this affect this Execu-
tive Order? Is there an issue there that says we have to look at
the cost versus the benefit?
Ms. Goldman. Yes, and we do follow the Executive Order very
faithfully, and when we do mcyor actions with pesticides we do reg-
ulatory impact analysis where we look at the costs and benefits,
and I will say as a decisionmaker that I find that to be helpful in
making decisions.
Mr. Burr. Very good.
Mr. Chairman, nl just end with a quote in the Detroit News. "If
the Delaney Clause were applied to nature, we'd all starve." Thank
you. I yield back.
Mr. Bujrakis. I thank the gentleman.
Dr. Cobum.
Mr. COBURN. Thank you.
I'm somewhat confused, and see if you can straighten me out. Is
there any language in this bill that precludes you from following
NAS guidelines and recommendations?
Ms. Goldman. None of the Ifinguage in the bill would prevent me
from using data about kids' diets and risks when I make a regu-
latory decision. But some of the language could be construed as
possibly, one, changing the standard that we use today for
noncancer risks and, two, allowing other considerations to override
the health risks.
Mr. CoBURN. Tell me where the language is that will change that
standard.
Ms. Goldman. Well, I think we have had a lot of dialog here
today about our concern over the need to clarify what the term
"negligible risk" would mean for a noncardnogen, and so I dont
think I need to go into that any more in detail.
Mr. COBURN. No, I think you do. I think we need to clarify it,
because what we have done is jumped all around that word and
haven't talked about it. I understand what "negligible risk" means,
and I understand what that means as a carcinogen, as a doctor and
as a physician and as a scientist. I don't have any trouble with you
applying that same language in terms of neurotoxicity or
mutagenesis or teratogenesis. So why is it that you all don't want
to use that language? Make we can change it to where we can
make it where it is something that you can use.
Ms. Goldman. Yes. Let me talk you through it. I think the major
issue for me, as a fellow physician, is, we do our work within a veiy
adversarial system, and we need to have language about the stand-
ard that is understandable not only for us hut also for the attor-
neys, regulated community, the consumer groups, all of those who
might be involved in the process, certainly all of those who might
want to challenge any decisions that we might make. So what we
dbyGoOgle
are looking for is either clarification from Congress about what ex-
actly would be meant by this language or a willingness to consider
language that has already gone through a considerable amount of
that kind of judicial and legal review so that it is clear to all the
parties what it means.
Mr. COBURN. And you do have a recommendation as to that lan-
guage?
Ms. Goldman. Right, we do.
Mr. COBUBN. And our committee staff has seen that rec-
ommendation?
Ms. Goldman. Yes, I think we have had an opportunity in the
last few days to interact with the committee staff on that.
Mr. COBURN. But getting back to Mr. Waxmsm's point in terms
of following the NAS guidelines, there is nothing in this bill that
will preclude you from following those guidelines or recommenda-
tions.
Ms. Goldman. There are two other areas that I should mention,
and one is the language on coordination between FFDCA and
FIFRA which, again, may be an area where we simply need clari-
fication on intent. But it could be read, it could be Interpreted, as
meaning that the FIFRA standards would override FFDCA stand-
ards, and, again, because of the adversarial nature of the system,
we want to be very careful to understand what is meant there and
to clarify it one way or the other. And of course, as I mentioned
before, to understand the benefits language and what Is meant by
that language and what it would override.
For example, there is a mention about environmental benefits
being weighed with the health benefits, and, franklv, I don't know
how to weigh off numbers of birds killed wltn babies with
neurotoxicity, and so we are concerned about very broad benefits
language like the language that is in the bill.
Mr. COBURN. So you would like to see that language tightened
up.
Ms. Goldman. We would like to see that tightened up. We think
we are going to need to work with you on that.
Mr. COBUItN. One other area. Tell me specifically what part of
the bill — ^where is FIFRA made more complicated by this bill?
Ms. Goldman. Yes, let me explain that. Today in current prac-
tice the way FIFRA is written, when we do a c2mceIlation and a
suspension of a pesticide, there is allowed a process that is called
an administrative hearing, and a lot of people involved in the sys-
tem, not just the agency but many attorneys, have looked at this
and felt that this is a very burdensome procedure. Recommenda-
tions have been made that that administrative hearing be replaced
with notice and comment rulemaking — that is what we proposed
last year. What H.R. 1627 does is, it actuEilly does have a provision
for notice and comment rulemaking, but it keeps the hearing proc-
ess as well. That actually then complicates the process by having
not just one but two, and, frsinkly, that is worse thfm current law.
On top of that, the standard for the hearing has changed. Today
the burden is on the maker of the product to prove to the public
that the product is safe. There is reference to coordination with an-
other statute, the Administrative Procedures Act, which we think
would shift the burden of the proof on to the Government to prove
DigilizcdbyGoOgle
82
that the product is not safe. This U done at the very end of the
FIFRApartoftheAct.
It also shifts the burden of the proof not just for hearings, for in-
stance, for suspension and cancelation, but also for what we call
a data call-in, which is one of the more important authorities which
we have under FIFRA. When we have a concern about risk, some-
thing crops up that we didn't predict when we registered the pes-
ticide, we can call in new data, but this language would bring tiie
data call-in procedure also into conformity vrith APA standards,
which would put more of a burden of proof on us. We don't really
think this would benefit the growers because we don't think it is
a good thing when uncertainties about pesticides are prolonged.
Air. BiLiRAKis. The gentleman's time has expired.
Pm going to yield to Mr. Pallone for a couple of minutes. Dr.
Goldman, the staff are available to sit down with you and try to
work out some of these Eireas, which are probably technical areas,
simificant Eireas no less, but something can be worked out.
Ms. Goldman. We appreciate that, Mr. Bilirakis.
Mr. Bilirakis. Mr. Pallone.
Mr. Pallone. Thank you, Mr. Chairman.
I just arrived so I was going to ask to yield my time to Congress-
man Waxmsm.
Mr. Waxman. I thank you for yielding.
There are some things Uiat we want to see if we can have a clear
statement in this bill to become law and that we all know we are
talking about the same thing, and I appreciate the chairman indi-
cating that the m^ority on this committee is willing to work with
you and the administration to clarify these points, and I think they
are important to clarify because you are right, in a lawsuit you
may not be able to do what you tiiink is appropriate to do.
But there is another point too. I think EPA and FDA and De-
partment of Agriculture ought to be told they must do certain
things to protect the public, because otherwise the bureaucrats —
to use a phrase that seems to be in favor at the moment when we
talk about anybody in government service — ^will be under an enor-
mous amount of pressure from industry groups not to do the things
that will protect the broader public healtn.
Dr. Goldman or Mr. Schultz, this issue of whether FIFRA has to
apply before any kind of tolerance would be applicable is not a
minor technical point, is it?
Ms. Goldman. No. We do think that the coordination issue and
how that might be construed Is very important. That is why we in-
cluded that in the testimony. The standard under FIFRA is dif-
ferent than the standard under FFDCA, and we would not want to
see FIFRA override our responsibility for protecting food safety.
Mr. Waxman. Would it be fair to say that if FIFRA did override
the standard, that there is really no health standard at all?
Ms. Goldman. Well, what it would mean is, it would be a very
radical departure from current law and really the laws that we
have had in place for a number of decades now to ensure food safe-
ty.
Mr. COBURN. Would the gentleman yield on just that one ques-
tion for a second?
izcd Dy CTOi
iogle
Mr. Waxman. Let me just get a clarification from the witnesses
and then I will.
Mr. ScHULTZ. I just want to add to that, you can have the best
safety standard in the world, but if then when you allow the bene-
fits to override that, you have lost everything you gained. So you
may have the best standards for children in uie world, but if that
risK is overridden by the benefit then you don't have anything.
Mr. Waxman. I can't imagine a parent in this counti? accepting
the idea that if there is a risk to their child's health from a pes-
ticide residue in food, that that will be ignored because of the eco-
nomic benefits to the agriculture and chemical industries, but isn't
that what we are talking about, Mr. Schultz?
Mr. Schultz. That is the issue we are raising, yes.
Mr. Waxman. We are not going to let a tolerance be set to protect
the public because that tolerance will be weakened because of these
other benefits being balanced in.
Yes.
Mr. COBUBN. I just wanted to get a yes or no answer to your
Suestion to the doctor in terms of — that that is no standard at all
' FIFRA is overridden. I don't think that is quite accurate.
Mr. Waxman. No health standard — ^no health-based standard is
really going to be applicable.
Ms. Gk>LDMAN. Well, FIFRA is a risk-benefit balancing statute,
and 80 there are health considerations that are strong consider-
ations, but it is very clear that we have to balance those health
considerations with economic considerations. FFDCA does not work
quite that way. There are considerations in terms of affordable,
Eibundant food supply.
Mr. COBURN. I understand how that works. I'm just saying in
terms of the response to Mr. Waxman's question, it is not truly a,
yes, there is no health standard at all, because the health standard
IS considered in making that decision.
Mr. Waxman. Again, to reclaim my time, it is considered and
then can be pushed aside while we look at this balancing out of the
economic interest.
What we are going to propose today in legislation is to say if we
are going to have this bill, let's at least have a statement in there
that if a pesticide is reasonably anticipated to harm children, then
the tolerance cannot be issued to allow that pesticide to be used.
"niat just seems to me to be a common sense thing that every
American parent would think makes sense not to let tneir children
be at risk for a neurological problem or birth defects or cancer or
anything else if their kids are at risk. I don't think we ought to bal-
ance it out and say, well, all things considered, we'll sacrifice some
kids in order to make sure that the economic benefits still flow.
Ms. Goldman. Yes, I should respond, I think, that we would
agree that protecting children is of paramount importance. We also
tmnk that the standards should protect adults as well.
The other thine that I would like to respond to
Mr. Waxman. Is that contradictory?
Ms. Goldman. That is not in contradiction at all.
Mr. BiLIRAKIS. Veiy quickly, Doctor. I^e time has expired.
Ms. Goldman. Yes. In terms of Congressman Cobum's comment,
I think that, again, we have to look at the very adversarial nature
DigilizcdbyGoOgle
84
a! the process that we are involved In and the opportunities that
this kind of linkage with FIFRA might give to attorneys who will
seek to overturn decisions, and not mat we wouldn't t^ to do the
right thing, but we just want to make sure that we would be able
to uphold those decisions.
Mr. BnJRAKiS. The gentleman's time has expired.
This panel is excused.
Doctor, I certainly appreciate your taking time to be here along
with Mr. Schultz and Mr. Elworth. We thank you, and we have
learned a lot.
Would the second panel please come forward. Dr. Carl Winter,
director of the FoodSafe Program with the University of California
in Davis, California; Mr. Leonard Gianessi is senior research asso-
ciate wi^ the National Center for Food and A^culture Policv here
in Washington; Dr. Geor^ Gray is deputy director of the Center
for Risk Analyses, Harvard School of Public Health. They are the
panelists for panel two.
Gentlemen, your entire written statement will be made a part of
the record. I will ask that your oral statement be limited to 5 min-
utes if at all possible.
We will start with you. Dr. Winter.
STATEMENTS OF CARL K. WINTER, DIRECTOR. FOODSAFE
PROGRAM. UNIVERSITY OF CALIFORNIA; LEONARD P.
GIANESSI, SENIOR RESEARCH ASSOCL^TE, NATIONAL CEN-
TER FOR FOOD AND AGRICULTURAL POLICY; AND GEORGE
M. GRAY, HARVARD CENTER FOR RISK ANALYSIS, HARVARD
SCHOOL OF PUBLIC HEALTH
Mr. Winter. Good morning, Mr. Chairman and members of the
subcommittee. I'm Dr. Carl Winter, and I'm a food toxicologist on
the faculty of the Department of Food Science and Technology at
the University of California at Davis. I'm also the director of the
University's FoodSafe Program which was established in 1992 to
facilitate the development and sharing of research-based food safe-
ty information. The program receives no funding from the agricul-
tural, chemical, or food industries. The views expressed today are
nw own and do not represent an official position of the University
of California.
I'm pleased to see that the committee is seriously considering
H.R. 1627 as a replacement for the Delaney Clause.
Back in the 16th century the Swiss physician, Paracelsus, estab-
lished the primary principle of toxicology when he wrote that all
substances are poisonous; there is none which is not a poison. The
right dose differentiates a poison and a remedy. To paraphrase
Paracelsus, it is the dose that makes the poison. 'This explains why
one aspirin may relieve your headache but a bottle of aspirin might
put you in the hospital.
Unfortunately, tne logic of such a simplistic statement is ignored
when one considers the Delaney Clause which prohibits the addi-
tion of any potentially carcinogenic additive to food regardless of
the level. Such an approach may have been prudent in 1958 when
our detection capabilities and understanding of the mechanisms of
cancer were less developed. In 1995, however, our continued en-
forcement of the Delaney Clause represents a scientiflc embarrass-
■d Oy Kj
oogle
36
ment which perpetuates misinformation and increases consumer
anxiety rather than providing meaningful public health protection.
JuBt as an aspirin may provide a suitable remedy for a headache,
H.R. 1627 provides a viable mechanism to replace Delaney with a
scientifically defensible approach capable of adapting to the evolv-
ing sciences of toxicology and risk assessment. Unfortunately, your
support of H.R. 1627 may be inappropriately construed by some of
your constituents as an endorsement for a little bit of cancer. This
notion is contradicted by the conclusions of the 1987 National
Academy of Sciences report which maintained that a uniform n^-
ligible risk standard applied to both raw and processed forms could
reduce rather than increase our theoretical risks from exposure to
potentially carcinogenic pesticides.
I mentioned the term "theoretical" in the discussion of potential
cancer risks to illustrate the complicated nature of risk assessment.
Our current practice of cancer risk assessment is an imprecise one.
At best, it is a crude quantitative tool to prioritize risks and allo-
cate resources and contains a ^at deal of uncertainty. In practice,
where uncertainties exist, scientists make conservative assump-
tions designed to increase the risk estimate so that errors are made
on the side of safety. Such a practice, however, may lead to exag-
gerated estimates of the actual risks. Thus, a calculated cancer risk
of one in a million using standard risk assessment techniques does
not mean that one person in a million will actually develop cancer.
liiis estimate represents an upper bound, and the actual risk may
be much lower or even zero. I have submitted for the record a
paper I published in 1994 which explores this issue in more detail.
Scientific advances are needed to improve risk assessment accu-
racy, as is evidenced by the recommendations of the 1993 National
Academy Of Sciences report on pesticides in the diets of infants
and children. H.R. 1627 provides the flexibility for incorporating
evolving and improving science into the dietary pesticide risk as-
sessment process by allowing the EPA to determine appropriate
ne^p^ble risk criteria. Such an approach eliminates the need for
a rigid and prescriptive bright line standard that is sure to become
a r^ulatory dinosaur as improved toxicological and exposure meth-
odologies are developed.
An important provision of H.R 1627 allows EPA the flexibility
to use the best available pesticide use and residue data to estimate
Exposure. Previous risk assessment efforts have commonly focused
on identifying the maximum legal exposures which assume that all
food items are treated with all possible pesticides, that the residues
are always present at the maximum Eillowable levels, and that the
residues in the flelds are the same as those on our plates.
This approach ignores substantial evidence demonstrating that
the w^uu use of pesticides in food crops is much less than 100 per-
cent, that the average residues are present at smalt fractions of the
allowable levels, and that things that you and I may do in our own
kitchens such as washing, peeling, and cooking foods may serve to
decrease residues dramatically. In work I have published pre-
viously, the more refilistic estimates of exposures are commonly
thousands to hundreds of thousands of times lower than those ob-
tained by estimating the maximum legal exposures. H.R. 1627 will
provide regulators Uie opportunity to more accurately estimate ex-
DigilizcdbyGoOgle
posures by considering realistic exposure scenarios rather than ar-
tificial and theoretical ones.
Good science makes good policy. It is now time for Congress to
make appropriate changes in our Nation's food safe^ laws by re-
placing the obsolete zero-risk standard of Delaney wiu a workable,
responsible, and modem negligible risk policy. H.R. 1627 provides
an appropriate vehicle to make this change.
Thank you for providing me the opportunity to share these views.
[The prepared statement of Carl K. Winter follows:]
Prepared Statement of Cabl K Winter, Ph.D., Director, FoodSafe Proorau,
Associate Extension Pood Toxicolooist, Department of Pood Science and
Technolooy. UNivERsmr of California, Davis
Good morning, Mr. Chaimuui and membeia of the Subcommittee. I am E>r. Cari
Winter and I am a food toxicologlat on the Acuity of the Dmartmant of Pood Sdenea
and Technolosv at the Unlvam^ of California at Davia. 1 am alao the Director at
the UniverritT'i FoodSafo Program, which waa eetabUabed in 1992 to fodUtate the
devekqunent and ahariiiK of reaeareh-baaed food aafe^ informaUon. The program re-
eeivea no flmding from uw anicultural, chemical, or food indtiatriea. The newi ez-
preaaed today are my own and do not repreaent an official poaition of the Univeraily
of California.
I am pleaaed to aee that the committee ia aerioualy conaidering H.R. 1627 aa a
re|daeement for the anachroniatic Delaney Claiiae. Back in tlie l6th century, the
Swisi phyaldan Phillipua Aureolus Theopnraatus Bombastua von Hohenheim, alw
known aa Paracelaua, eatabliahed the primary principle of toiicology when he wrote
that "all aubatancea are poiaona; there ia none which ia not a podaon. The ri^t doaa
diS^rentiatea a poiaon and a remedy." To paraphraae Paracelaua, it ia the doae that
makea the poiaon. Thia explaina my one aapirin may relieve your h aa dadi e . but
a battle d aapiiln mi|dit put you in the hoepital. Uiutetunately, the logic of tueh
a iimpliatic atatament la Ignored whan one eonaidera the Delaney Clauae, which pnK
hiblte the addition tt any potentially cardnooenic additive to food, remraleaa of the
1995, however, our continued eruTorcement of Uie Delaney Clause repreeenta an em-
barraasment which undermines our nation's sdentifie integrity and adentiflc lit-
eracy.
Just as an aspirin may provide a suitable remedy for a headache, H.R. 1627 pro-
vides a viable mechanism to replace Delaney with a adentifically-defeasible ^>-
proach capable ai adapting to the evolving sdencea of toxietdogy and risk assess-
ment Unfortunately, support of H.R. 1627 may be inappropriately construed by
tome as an endorsement for 'a little bit of cancer." "niis nobon is contoadicted \^
the condualona of the lEIS? National Research Council repent (1) which maintained
that a uniform n^ligible risk standard applied to both raw and processed fooda
could reduce rather than increase, our theoretical risks from exposure to potentially
carcinogenic pesticidea.
I mention the term "theoretical" in the discussion of potential cancer risks to illus-
trate the complicated nature of risk assessment Our current practice of cancer riak
assessment is an imprecise process requiring a series of judgments based on both
scientific and philosophical grounds. At heist it is a crude Quantitative tool to
prioritise ilska and allocate resources and contains a great deal of uncertain^. In
practice, where uncertainties eiiBt, sdentista make conservative assumptions de-
signed to increase the risk estimate so that errors are made on the side of safoty.
Such a practice, however, may lead to exaggo^ted estimates of the actual tiski.
Thus, a calculated cancer riak of one in a SUion tising standard risk assessment
techniques does not mean that one person In a million will actually develop ceiKer,
thia estimate repreeenta an uwer bound and the actual risk may be much lower
or even sero. 1 have submittea »r the record a paper I published in lEKH which ex-
ptorea this issue in more detail (2).
The uncertainty inherent in the risk assessment process must be appreciated if
aoprmriate science-based polidea are to be developed. Sdentiflc advances are need-
ed to improve risk assessment accural, and RR. 1627 provides the flodUlibr fi»
incorporation rf evolving and in^roving sdence into the dietsiy paslidda rise at-
rporatlon rf evolving and in^roving se
auat process by alltmng the EPA to d
L Su<£ an vinitach dinunatea tJie need
d by Google
standard that ii sura to become a imilatoiy dinouur aa impFovad tozicological and
expoaure methodologies are developed.
An imptntant pm^on of H.R. 1627 is that it allows BPA the flexitW^ to use
the beat avulable pestidde use and residue data to estimate exposure. Previous risk
asaessment ^forts have commonly fbcusad apoa identi^ng the maximum Icsal ex-
posures (thewetieal maximum residue contributiona) which auume that all fiwd
items are treated with all poaaible pestiddea, that the residues are always present
■t the WTimmn allowable levels, and that the reaiduea in the fields are the same
as thoae on our plates (1,3). Tbit approach ignores subatantial evidence demonstrat-
ing that the actaial use d pestiddes on fbod crops is much leaa than 100 percent,
that the average residues are prssant at small fraetioas of the allowable levels, and
that tfaiiwB that you and I m^ do in our own kitchens, such as washing, peeliiu,
and cookmf foods may serve to decrease residues dramatically. In work I have pub-
lished previously (4), the more realistic eatimatea of exposures are commonly thou-
sands to hunmids ^ Aousands times lower than those obtained by eatJmBQiig the
msirimum l^al es^osures. H.IL 1627 wiU provide r^ulators the opportuni^ to
mcve accurately estimate exposures by considering realiatic exposure scenarios rath-
er than artifidal and theoretical ones.
From a toxicoloKica] standpoint. It is critical that potential health raka from pes-
ticide reaidues be Balanced with potential health benefit*. The uae of pesticides may
enable consumers to purdtase an abundance of fruits and vegetables at affordable
coata, encouraging the liberal consumption of these foods, which have been shown
to dacntose certain types of cancer and heart disease. The Delaney Clause, unfortu-
nately, may eliminato many peatidda uses without adequate sdentific justification
leading to a lees abundant and more e:^enBlve (bod suj^ly; such a finding argues
strontfTy for the passage of H.R. 1627. On a more specific note, the use of some pes-
ticides may limit the preduction of naturally-occuiring tmins of far greater toxi-
colo^cal concern. Many fbngi, for ocampte, may produce significant levels of car-
dncgenic nurcotoxinB such aa aflatcmns if not controlled by fiingiddes. The recent
discovery of mycotoxina known as fiimonisins (6) and Allemaria tcniiis (6) in the
fiwd supidy amplify the need to control the production of such toxins by varioua
tschniques, laduding pestiddes.
Id summaiy, itfs now time for Congress to make appropriate chaiiBes in our na-
ticm's fbod safety laws by replacing the obsolete zero nsk standard of Delaney with
a woifcabte, responsible, ana modem negligible risk polli?. H.R. 1627 providea the
appnvriate vehide to make this change.
Tbwik you for providing me the opportunity to share these views.
Mr. Bujrakis. Thank you very much, Doctor.
Mr. GianeBsi.
STATEMENT OF LEONARD P. GIANESSI
Mr. GlANESSI. Thank you, Mr. Chairman.
My name is Leonard Gianessi. I am a senior research associate
at the National Center for Food find Agricultural Policy, an inde-
pendent nonprofit resesirch oi^anization here in Washington.
As a result of court rulings, EPA has announced its intention of
canceling 80 uses of pesticides that violate the Delaney Clause re-
quirements. My organization has recently completed a study which
calculates the potential economic impact of this Delaney enforce-
ment to be over $400 million a year. This study will be released
here next Tuesday, and we will make a copv of uie study available
for your record. Let me provide some examples.
In the U.S., potato growers are facing an epidemic of the potato
blight that caused the Irish potato famine of the last century- The
fbngus that causes potato blight recently mutated and is much
more difficult to control. Over the past few years U.S. potato grow-
ers have increased their use of fungicides to control this problem.
Hie two ^ngicides that are the mainstays of controlling potato
blight are mancozeb and chlorothalonil. EPA has listed both of
thurae chemicals to be canceled under their strict interpretation of
DigilizcdbyGoOgle
the Delaney Clause. Lost potato yields and increased production
costs totally $100 million per year for potatoes are the likely result.
Rice growers stand to lose the only fungicide that is efTective in
controlling rice blast, which is a disrase in the Delta States. In an
average year U.S. growers would lose about $27 million of rice to
Hob usease. Peanut srowere in 'SHrginia, North Carolina, Georgia,
and AJ^ama would lose about $18 million of peanuts every year
due to competition with weeds due to the use of less effective chem-
ical herbicides. Citrus growers in Florida would lose $14 million of
oranges every year to a disease that could not be controlled without
a Delaney targeted fungicide.
But these increased yield losses are just half the story. In addi-
tion, growers will be spending substantially more for alternative
diemicals. There are alternative chemicals for many of the Delaney
targeted uses in many cases. They work as well, but they cost
more. We estimate ^at cotton growers will spend about $40 mil-
lion per year for alternative pesticides as a result of Delaney. Cali-
fornia grape grrowers are likely to spend $22 million year; citrus
growers, $5 million more. So on the whole there will be lost yields
and considerably greater expenditures for pesticides as a result of
the Delaney actions.
Delaney enforcement actions do not consider benefits at all, and
some of the tainted pesticide uses are key to successful integrated
pest management programs. Let me give you an example.
In California ^rape vineyards have several natural predators of
the insect. Certain beneficial insects exist in these vineyards that
eat some of insect pests of grapes. Now when California ^rape
growers have to use a chemical they choose a chemical that is se-
lective in that it kills harmful mites but doesn't damage the bene-
ficial insects. But this pesticide, propargite, is listed for a ban
under EPA's Delaney Clause enforcement. Growers will be forced
into using alternatives that are not so gentle on these predators.
The Department of Agriculture, in a report that they issued just
last year, estimated that without this chemical the use of insecti-
cides in California grape vineyards would double. Grape growers in
California would be forced into using another chemical, spraying
more, spending more for pesticides, and disrupting their integrated
program.
Now one of the first actions that EPA took in enforcing Delaney
was to cancel certain emer^ncy registrations for which there were
Delaney concerns. What would have been the results? In the
Northwest, mint growers were panted the emergency use of an
herbicide to control weeds for which there were no other registered
means of control. EPA then revoked the emergency registration be-
cause of Delaney. Mint yields in Oregon declined by 13 percent in
the first year, 1993.
In North Ciirotina EPA acknowledged an emergency condition for
apple growers by providing a registration for a fungicide to control
a disease that had just recently entered the United States and for
which there was no adequate control. Then EPA canceled that pes-
ticide because of a Delaney concern. 1994 was a very wet year in
North Carolina. The disease flourished in the State. Growers had
no way of controlling this disease. 1994 apple production in North
Carolina was about 60 million pounds below normal production
d by Google
level. The fiuunu, the diaeaee, got about 60 million pounds of ap-
ples in North Carolina because of Delaney enforcement.
Tlie Delaney Clause is a strict requirement. It allows no consid-
eration of the benefits of a chemical use. EPA is moving to cancel
80 pesticide uses. If that poli<7 is carried out there will be substan-
tial losses to U.S. agriculture.
Thank you.
[The prepared statement of Leonard P. Gianessi follows:]
My name ii Leonard GUimn. I un a Senior Reaearch AModato at tbe National
Center for Food and Agricultural Policjr— a imall, indapandant, non-profit naearch
organization liere in Wuhington. My cmninenta addrea* the pctenttal economic im-
pacta of Delaney Clause ei^rcement on U.S. agiieulture. Aa a result i^ court rul-
inn, EPA has announced its intention of fanwiling certain uaea of peaticidea that
viMste IManey Clause requirementa. H.R. Iffi27 would remove the threat of pea-
tidde cancellations under Delaney by specificaUy excluding pestiddes from consider-
ation as food additives. EPA hn identified approximately 86 pesticide uses that
would be canceled under the current strict inten>reta1ion of Delaney. My organixa-
tion has conducted a study which calculates the potential econonuc impact to be
over 400 million dollars a year. This study wiU be releaaed hve next Tuesday. We
mil make a copy of the study available for vour hearing record.
The basic premise of our studv is that ii fBrmers ore unng a chemical on a large
number of crop acree, they are doing so because the chemical is the most cost.efi'ec-
tiva solution to a pest control problem. Thus, if the chemical were to be removed
throu^ government action, growers would select the next-best alternative, often at
consideru)!^ greater ei^ense or loei in efTediveneaf. The loss of these chemicals will
result in himer costs of control for growers, tower yields, and a disruption of pest
maoagement stratenes — some of which are designed to reduce pesticide use. Let me
provide some eiamples.
LOWER YIELDS
In the U.S., potato eroweia are facing an epidemic of the potato blight that caused
the Irish Potato Famine last century. The fungus that causes potato blight recently
mutated and is much more difficult to control. Over the past finv years potato grow-
ers in Pennsylvania, Maine end Wisconsin have increased their use of ninsicideB to
control this disease. The two fungicides that ore the mainstay of potato bfight con-
trol are Mancozeb and Chlorothalonil. Both of these chemicals would be canceled for
use by potato growers under a strict interpretation of the Delaney Clause. U.S. po-
tato growers would be left with less efiective, more expensive mateiiols for control-
ling tnis increasin^y virulent disease problem. Lost potato yields and increased pro-
duction costs totaling $100 million per year are the hxely result.
Rice growers in the Delta states of Mississippi, Louisiana, and Arkansas are fac-
ing an epidemic of a disease called "rice blast, which literally "blasts" the rice ker-
aa out of the rice plants. In uncontrolled rice blast epidemics, rice yields decline
by 75-80%. Rice growers stand to lose the only fungicide that is effective in control-
ling rice blast as a result of a strict interpretation of the Delaney Clause. In an av-
erage year for rice blast, U.S. gmwen would lose $27 million of rice to the disease.
With regard to both potato blight and rice blast, we're talking about virulent, seri-
ous diseases of plants with trillions of d^ase spores floating around in the environ-
ment Todui, growers are controlling these diseases with the use of chemicals. With
a etrict enfcn-cement of Delaney, efiective control disappears; yield losses increase;
rice and potato planta will become diseased and rot
Increased louee of apple production to uncontrolled diseases would also be about
$100 million as a result of Delaney actions. Several years ago, EPA concluded a Spe-
cial Review of the EBDC fiingicides. EPA was higbly complimentaiy to the apple
industry, which had conducted studies of pestiddB residues and found that they
were negligible or non-ezietent. So EPA was convinced that continued use of the
EBDC fungicides would pose no significant risk and that the benefits were substan-
tial. Today, those very same registrationa are targeted for cancellation due to
Delaney concerns. Notiung has changed. The risks of the EBDC fun^ddes on apples
are negligible— are below negligible— and the benefit* are subttantial.
Our study goes crop-by-crop and SUte-by-State and delineates the crop losses that
would occur under the potential Ddan^ enfbrcement
DigilizcdbyGoOgle
• Peanut powen in VirginiaL, North Candina, Georgia and Alabama would kae
about $18 million of peanuta due to competition with weeda, due to the uae of
leaa-effective chemical heririddea.
• Flum growen in California would loee 10% of their pluma on 22% of their acreage
due to the feeding of mitea that would be lesa effectively controlled with alter-
nativea.
• Citrus growers in Florida would lose iU million of orangee to a diaeaae that could
not be controlled without a Delanty-targeted fimgicide.
• Tomato growers in Florida would loee Sir million in tomato production to a dis-
ease that could not be controlled without a Delaney-liated ftingidde.
mOHER COSTS
Increaeed yield losses are only half Ihe story. In addition, growers will be spend-
ing more fiir alternative chemicals. There are alternative cnemicala fbr numv uaet
that are targeted by Delaney Clauae en&wt«ment. In many casee, they would woik
aa well, but they are more ezpwuive. Thus, growers are ciurently using the less-
e»enaive chemicals that are targeted by Delancnr.
We eatimate that cotton growers will «-— ' *'" -
native pestiddesaa a result of Delaney.u ■-- ,- ^- ,
$8 million more per year for alternative fungicides to control mildews. Civus grow-
ers are likdy to spend $5 million mwe in peeUdde purchases as a result of Delaney.
Wheat growos in Arkuiass, Louisiana, Kentucky ioA Tenneetoe are Ukehr to meai
$S million more to control disesses as a result of Delaney. So, on the whole, uiere
will be much greater expenditures for peetlddes as a result of Delaney actions that
remove cheaper compounds.
DISRUPTION OF PRODUCTION PRACTICBB
Delaney enforcement actions do not consider benefits at all. Some of the taiveted
pesticide uses are key to succeMfiil ongoing IPM (Integrated Pest Management) Pro-
grams. Their cancellation will result in negative impacts on the IPM programs. Let
me give you an example;
In Cafifomia grwe vineyarde, several natural predators exist Certain beneficial
inaects eat some oi the insect pests of grapes. So grape erowers don't have to use
chemicals constantly to control certain pests. When Calilomia f^pe growers have
to control mite*, they choose Propargite because this chemical la selective-^t kills
the harmful mites and does not damage the natural predatory insects. Propai^te
use on grapes is listed for a ban under the Delaney Clause niforcement. (lowers
will be forced into usin^ alternatives that are not so gentle on the predators. The
U.S. Department of Agriculture, in a report issued in 1994. estiinated that without
Propargite — the number of insecticide applications in California grape vineyards
woiild double. Grape growers in California would be spraying more often, spending
more for peeticideB, and lolling natural predators. All because of a cancellation due
to Delaney concerns.
PRESENT IMPACTS
off the list. EPA may grant new registratioas, or emergency registration of producta
that would mitigate the ne^tive conaequencea of canceling thMe {testicides. I know
that there are some skepbcs out there who daim that the negative consequences
never seem to materialize when EPA cancels a pestidde. Let me assure you that
some negative eflects have alreachr resulted frmn EPA Delaney actions.
One of the first actions that EPA took with regard to Delaney was to cancel emer-
rancy registrations of compounds for which there were Delaney concerns, EPA took
's action in 1993. Basically, EPA had concluded that growers in certain areas of
ST.
ttie country fitced emernncy pest control problems which the emergency resiatra-
tions would alleviate. EPA granted the emergency registrations under Section 16 of
FIFRA and then revoked them beeauae of Delaney concerns. What have been the
results?
• In the Northwest, mint growers were granted the emergency use of an herbidde
to control weeda fbr which there were no other means of cmitrol. EPA then re-
voked the r^istration because of Delaney. Mint yields in Oregon declined by
13% in 1993— a loss of 625,000 pounds of mint oil due to uncontrolled weeds
which could have been controlled if the emergenqr registration was aUowed.
In North Carolina, EPA acknowled^^ an emergency condition for apple growers
by providing a registration for a fiingidde to contrd a disease that had Just recently
cntarad tbs U.S. and iir wlikfa than w«n no ftdoquata
3 w«a « dry tmt. and th* ftingus didn't do wdl. So North Canliiu upl* produc-
tiiHi did not dedine In 19D3. However, 19M was ■ very w«t jrear. Tht niiwui flour-
ished, and growen wen left with no effective meuu of contiol. 1994 apple produc-
tion in Nnlli Carolina was about 60 million pound* below the normal prodtiction
level.
The Delaney Clause is a itrict requirement that allows no consideration of the
beneSta of a diemical use. EPA is movitw to cancel 86 oeatidde uses for which the
risks are tnilj ne^igible. If that poUc
culture will be greater than $400 miU
pesticide costs.
Mr. BILIRAKIS. Thank you, Mr. Gianessi, for sharing those stories
ivith us.
Dr. Gray.
STATEMENT OF GEORGE M. GRAY
Mr. Gray. Mr. Chairman, members of the committee, thank you
lor the opportunity to come before you today to support the Food
Quality Protection Act of 1995.
Fm George Gray, deputy director of the Harvard Center for Risk
Analysis at the Harvard School of Public Health. As a toxicologist,
risk analyst, and public health professional, there are three points
I would like to make today.
First, the Delaney Clause is slowing progress toward reducing
risks from pesticide use. You will hear many times that the
Delaney Clause is scientifically and practically nonsensical. This is
true. But not only does it not make sense, the Delaney Clause is
putting consumers and farmers at risk. New generations of pes-
ticides are much aafer for both humans and the environment tnan
those that came before. Even these pesticides, however, when fed
to animals at very high doses, may be considered carcinogens. The
Delaney Clause, oy denying farmers the use of these new mate-
rials, is prolonging the use of more dangerous older pesticides.
In addition to keeping newer pesticides out of the hands of farm-
ers, the Delaney Clause may be causing harm by its focus on can-
cer. It may be that the EPA and the f£u-ming community would
rather see a weakly carcinogenic pesticide with very low risk used
in place of a pesticide with clear neurotoxicity or reproductive tox-
icity, Similju-ly, the focus on cancer risk primarily to consumers
may preclude the introduction of pesticides that could reduce risks
to fanners or farm workers. I believe that the negligible risk stand-
ard developed in H.R. 1627 will allow EPA to move toward lower
risk methods of crop protection.
My second point is that risk assessment is the tool for ensuring
the safe use of pesticides. I'm a strong believer in risk assessment.
Advances in the science and the methods of risk assessment are
improving the quality of information that we can bring to bear in
questions of human and environmental health. Risk assessment for
pesticide regulation must make good use of all available science,
assess fill types of risk, not just cancer, and should evaluate risks
to consumers, workers, and tne environment.
Just for instfmce, a new pesticide product that reduces risk to
consumers may produce harm to farmers or to the environment. As
an example, consider DDT, a pesticide of very low toxicity to hu-
mans, which was banned in 1972 due to concerns about toxicity to
DigilizcdbyGoOgle
fish and birdB. The most common substitute for DDT, parathion,
poses less risks to the environment but caused many poisonings
among farmers. Consideration of the risks of alternative pest con>
trol methods and the way in which those risks can be managed is
key to the safe use of pesticides.
I fully support the goals of H.R. 1627 to develop a better under-
standing or differences in pesticide exposure for children and to
consider this in tolerance setting. However, I ui^e that the consid-
eration of differences in exposure not stop with children. Of course
we are concerned about that part of our population, children, who
consume more apple juice than average, out shouldn't we also be
concerned about the part of our population that consumes more
prune juice than average? Different patterns of food consumptioti
m difTerent age groups, ethnic groups, or regions of the country
should not be ignored.
I also commend the authors of H.R. 1627 for reco^izing that dif-
ferences in risk can be due not only to differences m exposure but
also differences in susceptibility to the toxic effect of pesticides.
Again, the focus on chilmen is good, but I would urge that better
research and risk assessment methods be encouraged for all
groups. For instance, toxicologists know that adult rats are much
more sensitive to the acute toxic effects of DDT thfin are newborns.
Let's make sure that we consider all members of the population.
My final point is that benefits, both economic and Health related,
must be considered as part of a sound pesticide policy. Congress
recommended when first writing FIFRA and FFDCA that the many
benefits of pesticide use must be considered when regulating their
use. I urge that the sections of H.R. 1627 dealing with benefits
make explicit the consideration of benefits to farmers, consumers,
and the environment, and it must also be recognized that these
benefits can be economic or health related, better health due to bet-
ter diet and the reduction of risk from other pesticides or the risks
induced by pests. Others can speak more directly to the clear eco-
nomic benefits of pesticides, but I would like to remind you of the
health and risk reduction benefits of pesticides.
Pesticides make an important contribution to American public
health. For example, fruits that are inadequately protected against
pests have been shown to have lower nutritional value — for exam-
fle, less vitamin C in apples than fruits that have been protected,
n addition, by lowering the price of producing food, pesticides
lower the cost of food for consumers. We know that eating fresh
fruits and vegetables can protect against cimcer, heart disease, and
other ailments, and we must be concerned that higher prices will
reduce consumption of these health protective foods.
It is frequently recognized that pesticides can reduce the risk
from natural toxins. For example, the risks of fungicide use on pea-
nuts must be weighed against the benefit of reducing the carcino-
genic risk of aflatoxin that would grow in its absence.
It is less often recognized that some pesticides have the benefits
of reducing risks to farmers, consumers, and the environment. The
benefit to consumers arises when a less risky pesticide takes the
«lace of a more risk^ alternative. The benefit mr farmers is similar,
^e must consider nsk reduction for farmers as an important bene-
fit of pesticides.
\
DigilizcdbyGoOgle
43
For the environment we must recognize that use of pesticides has
reduced the number of acres of land required to grow food in this
country, increased the use of land to grow the same amount of food.
The consequence of the losses on pesticides is a benefit or in fact
a disbeneflt that should be considered. The benefit is illustrated bv
a case study that I did for a book for the Harvard Center for Risk
Analysis in which the primanr fungicide
Mr. BnjRAKis. Would you nnish up please, Doctor?
Mr. Gray. The primary fungicide used to control mildew on let-
tuce also «)ntrolled several other fungal pests. Since no alternative
did the same, loss of this fungicide would have required at least
two additional pestiddes to control fungi in lettuce, tiiereby in-
creasing the total environmental burden of pesticides.
In conclusion, I would like to say that the bill before you today
will provide a clear benefit to public health. Elimination of the
Delaney Clause through a uniform negligible risk standard will re-
store scientific credibility to i>esticide policy, prevent the problem
of the use of new, safer pesticides being denied to farmers, and
tend the regulatory preoccupation with cancer sometimes to the ex-
clusion of other risks to the nealth of farmers and consumers.
Use of risk assessment especially with a focus on variability in
exposure and differences in susceptibility will ensure pesticide use
will be safe for all members of society. An explicit consideration of
benefits will make sure that the economic and health gains from
pesticides will not be ignored.
Thank you very much.
[The prepared statement of George M. Gray follows:]
h«alth profeMional I have 3 key poiDta that I wouldUke make today. First, the
Ddaney ClauM is Blowing progreBs toward reducing risk from pesticide use. Second,
hik assesameot is the tou tbr ensuttog the safe use of pestiddes. Finally, beneSts —
both economic and health related— must be considered as part of a sound pesticide
policy. I will DOW address each in turn.
Th» Delamy Clauae u Sloioing Pmgreea Totoard Rtduang Ruk From Peatieide Use
You will hear many times today that the Delaney Clauae scientificaUy and prac-
tically makes no sense. This is true. Yet not only does the Delaney Clause not make
■enae, it is alao putting consumers and farmers at risk.
New generations of pestiddes are much safer for both humans and the environ-
ment than those that came before. Even these pesticides, however, when fed to ani-
mals at extreme^ hi^ doses may be considered carcinogens. Many of these new
pestiddea are onqr weaUv carcinosenic, causing tumors cmly when present as sev-
«ral percent of an animal's diet. Tne Delaney Clause, by denying ftrmers the use
of these new materials, is prolonging the use of older, often more dangerous, pes-
ticides. I found an example of this in a case study I wrote for an upcoming book
from the Harvard Center for Riak Analysis. The ease studv focused on control of the
fUngal disease downy milder on lettuce. It was clear in this case that the Delaney
Clause prevented use of a lees risl^ fUngidde leaving only older pestiddes as fiing^
control options.
In addition to keeping newer, safer, pesticides out of the hands of farmers the
Delaney dause m^ harm health by its focus on cancer. It may be that the EPA,
and the forming communis, would rather see a weakly cardnogenic pestidde with
ve^ low risk used in place of a pestidde with clear neurotoxicity or reproductive
toxid^. Similarly, the focus on cancer risk, primarily to consumers, may predude
intro^ction of pestiddes that could reduce risk to farmers uid fkrm workers.
DigilizcdbyGoOgle
vonen.
RiakAMtMment ia Iht Tool for Etuuring the Safe Um of PeatiddeM
I un a strong believer in risk eeaeHment. Advance! In the idence and nwthodi
of risk aaaeaament are improving the quality of the infonnation we can bring to bear
on Queationa of human aim environmental health.
Riak aatewment for peaticide r^iulation muat make good uae of all available
■dence, aaaeaa all typea of riak, not only eanoer, and ahould evaluate riaka to eon-
■umera, workers, and the environment It is important that regulators have the
flexibili^ to consldtt- risks to not only constunars, out workers and the raivironment
aa well. For inatance, new peatidde producta that reduce risk to consumers may
harm workara or the environment. As an example consider DDT, a pestidde otvtrj
tow acute tmodty to humane which was banned in 1973 due to concema about tn-
idt; to fiah andbiiila. The moat ctmunon substitute for DDT, parathion, poaad laas
riak to the environment but caused many poisonings among lannera. Ccmaideration
of the riaks of alternative pest control mettiods, and the ways in which those risks
can be managed, is key to safe use of pestiddee.
I fUlly support the goals of H.R. 1627 to develop better understanding of dif-
ferences in pesticide oqwaure for children and to consider this in tolerance settiiv
However, I would urge that conaiderataon of diSerencea in exposure not stop with
children. Different patterns <^ food conaumption in different age groups, ethnic
groups, or ruiona of the country ahould not be ignored.
I commeniT the authcna of KR. 1627 for reeognising that difforences in riak can
be due not oi^ to differancea in exposure but also to <iiffl»i«in«. in suseeptibili^
to tlie toxic efiects of pestiddes. Again, the fbcua on children is good, but I would
urge that better research and risk sssaa am en t methods be encounged for all age
groups. For instance, toxicolagistB know that adult rats are much more sensitive to
the acute toxid^ of DDT than are newborns. Lets make sure we considn all moa-
bers of the popmation.
Risk a s s es sm ent is th_ ,__^
safe use of pestiddea. Conduct and use o . .
allow EPA to respond to advanced in science and to use its judgment in evaluatiiig
fNMtidde use. H.R. 1627 will lead to improvements in the infbimatiOQ developed by
lirii aaaeaament, allowing better rcsulatory decisiona.
- -Both Eeonomie and Health Related— Mu^ be Cotuidered a* Part ^ o
Sound Pmtiade PoU^
Congress recognized when flrst writing FIFRA and the FFDCA that the many
benefits of peatidde use must be considered when r^ulating their use. I urge that
that benefits can be economic, better heslth due to diet, and roductlon of riuc&om
ol^r pestiddea or hazards induced by pests.
Other* can speak more directly to the dear economic benefits of peatidde use but
1 would like to remind you of the health and riak reduction benefits of many pes-
^Btiddes make an important contribution to American pubUc heslth. For exsm-
Ele, fi^ta that aro inadequately protected againat pesta have been shown to have
nvo- nutritional value, induduig lesa Vitamin C m applea, than fi^ts protected
with pestiddea. In addition, by lowering the price of produdng food pestiddea lower
the coats of food toi consumers. We know that eating freah frtuta and vegetablea can
protect against cancer, heart disease and other ailmisntB and we must be concerned
that hi^er prices will reduce consumption of these health protective foods.
It is &equently recognized that pestiddes can reduce the risks from natural tox-
ins. For example, the risks of fbngidde use on peanuts must be wraghed s^ainst the
benefit of redudng the cardniwenic risk of ailatoxin produced by fiingi m its ab-
sence. It is leaa otteD recognised that some pesticides nave the ben^t of redudng
risk to consumers, formers, and the environment. 'Hie benefit to consumers arises
istive. The benefit
_._ , a SB an important
benefit at pesticide use. Evm organic formers are at risk. Organic formers employ
natural pesttcidee that can be just as trade and carcinogenic a* synthetic pestiddea
even thou|^ they are less thorou^ify tasted for toxidty. For example, in California,
the state with the most thorough system for reporting occupational disesse caused
by pestiddes, the pesticide with the highest number itt reported illnesses in the pe-
Digilizcd by LjC'KIQ IC
4S
liod 1984-1990 wu nilftir, a pesticide widdy us«d on "organic" farms. Use of pes-
ticddes hu reducad the number of acret of land required to grow food in this coun-
try. Increased use of land to grow tbe same amount of food, a eonsaquence of loss
of some pesticides, should be considered in benefit assessment. Another environ-
mental benefit is illustrated by an exampla from my lettuce case study- The primary
fiingidde used to control downy mildew on lettuce also eontroUea sevoral other
flingal pasts. Since no alternative did the same, loss of this fUngidde would have
required at least two additional pesticides to control flingi on lettuce thereby in-
creiuins ttie total environmental bvu-den of pesticides.
I would also encourage the development <» better benefit data to aid dedsion mak-
ing. For example, is t£e already considerable acddent risk to Esnuen increased if
more land tiUing rmlaeos pesticide use? For consumers, are the economic benefits
of pesticide use uniiorm at are some groups more vulnerable to price increases? For
the mvironment, would tiie use of one broad spectrum pesticide reduce the pesticide
load and potential impact on the environment We must cast our net widely in con-
sidering beniafits to ensure appropriate regulation of pesticides.
Condusum
The biU before you today, H.R. 1627, will provide a dear benefit to public health.
Elimination of the Delaney Clause, through a uniform negligible risk standard, will
restore icientifie credibili^ to pesticide pdicy, prevent the problem of the use of
new, nier pesticides being denied to fkrmeis, aiid will end reguletoiv preoccupation
with cancer, sometimes to the exclusion of other risks to the heolu of consumers
and fiumers. Use of risk assessment, especially with a focus on vari^nlity in expo-
sure end difEsreoces in suseeptibaity, will ensure that pesticide use will be safe for
all members of sode^. EnBcit cmsideration rf benefits will make sure that the
economic and health gains from pesticide use will not be ignored.
lluuik you very much for the opportunity to testi^ today.
Mr. BnjRAias. Thank you, Doctor.
ni start off the questioning. Dr. Gray, you are a medical doctor?
Mr. Ghay. No, I'm not; I'm a ttHdcologiat.
Mr. BlUHAKiS. You are a toxicologiat, and you are with the Har-
vard School of Public Health. How long have you been with them?
Mr. Gray. Seven years.
Mr. BruEAKiS. Seven years?
Mr. Gray. Yes.
Mr. BiLiRAKlS. Now, Dr. Winter, are you a medical doctor?
Mr. Winter. No. I'm also a toxicolo^at.
Mr. BiURAKia. They say you should always know the answer to
every question before you ask the question. I guess I should have
known the answers.
I feel certain that you three gentlemen care every bit as much
about public health as we do— that is your field afier all — and you
care suMut the effect of pesticides, the adverse effect that they
could have upon not only children but, as you indicated, the elderly
and the rest of us somewhere in between. I always consider myself
somewhere in between regardless of what age I might reach. You
have no axes to grind as far as I can see.
Do you see a conflict between H.R. 1627 and the public health?
Tve indicated an interest, in sitting down with the administration
and working out some of these areas. But is there a conflict be-
tween public health, the health of children, the health of the elder-
ly, the health of people in general, and what we are trying to do
in H.R. 1627?
Mr. Gray. I certainly do not think that there is. In fact, I believe
that the use of a uniform negligible risk standard is generally a&
captod in the scientific community and in fact was put forth by the
Nati<mal Academjr of Sciences as a way to really make sure that
ws are using pesticides in the safest way possible.
DigilizcdbyGoOgle
Mr. BlLlRAKlS- Getting to some of the testimony given by Dr.
Goldman, should the Congress be more detailed — ^1 mean are we
better scientists than EPA may have on it staff?
Mr. WiNTEB. I would certainly commend EPA for their scientific
leadership in this area. I think they certainly have the tools and
the people to apply the best adenoe that is a'railable provided that
they have the resources necessary to allow them to use the best
data, to generate the best data, to use the best models. I think pro-
vided that they have those resources and that there ia some unaer-
standing about maybe some spedfic language, the issue of neg-
ligible risk versus reasonable certainty of no harm can actual^
have some differences, and I think that is something that hopefully
can be worked out with the committee.
Mr. BnjRAKis. Certainly whatever resources they have, they
have got to have more than we have.
Mr. WiNlSR. Right
Mr. BiLlRAKls. Ithink you would agree.
Mr. Winter. I think they are high^ qualified, they are the lead-
ers in this area, and they are the best people to do this ^pe of lisk
Mr. Bujraeis. The administration points out that H.R. 1627 is
resjwnsive to the NAS report on pesticides in the diets of infants
ana children and that it provides measures to ensure that needed
information about children's diets and pesticide residues are avail-
able. However, the administration would like to see requirements
that this information, along with information about susceptibility,
be used in developing tolerances. Could you please comment?
Mr. Winter. From my perspective, I think that that information
can and should be used, imd I don't see that H.R. 1627 in any way
precludes EPA from using that data.
Mr. BnJRAKLS. Mr. Gianessi?
Mr. Gianessi. I agree with that.
Mr. BnjRAKis. Dr. Gray?
Mr. Gray. I do as well. It seems to me that it is explicitly written
in H.R. 1627 that the administrator shall take account of a variety
of things, including risks to particular subgroups, especially chil-
dren.
Mr. BnjRAKis. Current law seems to be silent insofar as children
are concerned and H.R. 1627, according to some of the questioners
earlier today, is not aa strong in that regard. Is there anything ^at
would preclude EPA today, from expanding basically its role as a
regulator to basically go into the children's safety area?
Mr. Winter. I am unaware of anything.
Mr. BlLlRAKis. There is not, is there?
Mr. Gray. There is not, and in fact in many cases they do look
at risks specifically for children now. In fact, by giving them broad
discretion it has been allowed.
Mr. BiLIRAKIS. Thank you. Thank you gentlemen. My time has
expired. Thftnk you so much for your viewpoints.
Let's see. Mr. Burr, I guess, would be first.
Mr. Burr. Thank you, Mr. Chairman.
Dr. Winter, 37 years ago — and I'm assuming that you are over
37
Mr. Winter. I was bom in the year of Delaney.
dbyGoijgle
47
Mr. Burr. Okay — could you have come up with the same conclu-
sions as you have today about your comments?
Mr. Winter. Well, I think 37 years ago, as I mentioned,
Paracelsus told us back in the 16th centuiy that the dose makes
the poison. I think we have certainly come much further in the
past 37 years in terms of understanding how chemicals may cause
cancer as well as being able to detect chemicals in the environ-
ment. I think what was possibly prudent in 1958 certainly is obso-
lete now.
Mr. Burr. So the technology exists today for us to understand
the effects much better than tney were 37 years ago?
Mr. Winter. Absolutely.
Mr. Burr. And I think all of you have commented on the NSA
Xrt, but let me — you mentioned ranges, and we have certainly
)d with the EPA about the tolerance levels and this ^pe ot
thing. Science is not exact, there is a need for a range, and I think
we err on the side of safety in every case, and can you just com-
ment a little bit about the need for a range and where that target
should be in that range?
Mr. Winter. Ok^. That is a great question. As one toxicologist,
I have my philosophy. I think one of the mfyor principles of toxi-
cology today is that ror every Ph.D., there is an equal and opposite
Ph.D., and as a result of that we will see a wide variety of^ views.
I think it is very prudent to make sure that when we deal with
uncertainty, that we do try to err on the side of safety. However,
there comes a point in which the calculations of risk take on mag-
nification of so many uncertainty factors that the ultimate number
that comes out of a risk assessment hzis very little relationship to
the real world and, if not understood in its proper context, is sub-
ject to misrepresentation, which may ultimately lead to some bad
polity.
I have included for the record a publication that I wrote in 1994
which goes into much more detail about the uncertainties, the need
to correct for them, and also the need to understand them.
Mr. Burr. Thank you.
Mr. Gianessi, Dr. Goldman said consumers would not feel the
economic impact if there were not a change in Delaney, and I think
she alluded to the fact that if there was a change in Delaney. Now
you talked about economics a little bit. Can you expand as to what
the impact would be?
I happen to be from North Carolina and you used quite a few ex-
amples of North Carolina.
Mr. Gianessi. Right. I think what the doctor said was that her
economists didn't ^culate the results through to the consumer
level, that the way the EPA analysis is done is to go through and
calculate in a similar fashion what we have done, the potential
yield losses and the potential coat increases in terms of increfised
expenditures for pesticides. We don't have the economic models to
go all the way through to consumer levels for many of these crops.
The other wild card in a lot of these calculations is, what do you
assume about imports? If you allow imports to come in freely as
substitutes, if you allow shifts in production around the United
States, many of these economic effects would be mitigated. But on
the other hand, these — we try as toxicologists in terms of coming
DigmzcdbyGoOgle
48
up with some proxy to let you know that there would be some eco-
nomic effect.
Mr. Burr. Let me use your example of apples in North Carolina.
"Die yield was down 60 percent from an apple fungus.
Mr. GiANESSi. Rieht.
Mr. Burr. Would common sense tell me that the price of apples
was going to go up if I go to buy them?
Mr. GlANESSI. Well, m North Carolina those were Red Delicious
apples. I think you are still going to see Red Delicious apples in
all those supermarkets in North Carolina. They are probably not
produced in North Carolina, they are probably coming from Wash-
mgton and other States. They may be priced about the same. Th^
are not North Carolina apples. Growers down there would be tak-
ing losses, workers who pick apples in North Carolina would be
tfuiing losses, packers down there would be taking losses, so in that
case we would expect, because it is a national crop, that there are
localized economic effects, but probably not a price increase.
Mr. Burr. Okay.
Dr. Gray, you talked about the fact that as we substitute pes-
ticides, let's say that 80 some pesticides are taken off the market
by the EPA because of the court decision, that in fact we have some
aitematives that are out there, but, under vftrying usages or the
amount that is used, that the results as far as health could be
worse. Was that a correct understanding on my part?
Mr. Gray. It certainly was, and in fact that echoes the quote I
think used from Science magazine from Dr. Goldman that it is en-
tirely possible that substitution can actually increase risks to pub-
lic health.
There is the example of removing something from Delaney be*
cause of concerns that ctircinogenesis could lead to more wide-
spread use of something with some other toxic effect or somethii^
that might have potential harmful effects on the environment.
Mr. Burr. So just to follow up real quick, Mr. Chairman, if we
substitute a chemical that works 75 percent as well as the last one,
is it likely that a farmer, once he realizes that if he uses twice as
much to get the same results, might do that even though the in-
structions on it say to onlv use X?
Mr. Gray. I can't speak to that. I assume that farmers usually
try and follow
Mr. Burr. Well, let me try and let you speak from what would
happen from the a tcndcology standpoint if 75 percent were equal
to 100 percent of
Mr. Gray. Well, we are not at all sure, but presumably you
would be exceeding the tolerance on that food, the farmer would be
taking a chance on having it confiscated and adulterated, and even
if it weren't it would be increasing the possibility that people could
be harmed.
Mr. Burr. But the habit would exist from a possible agricultural
community that to achieve the same results as the pesticides be-
fore, that they might be more inclined to use those chemicals in a
different way to achieve that?
Mr. Gray. Or plant 126 percent more acres. I mean there are
other ways.
Mr. Burr. Okay.
DigilizcdbyGoOgle
I yield back, Mr. Chairman.
Yea — not in terms of apples.
Mr. BiLiRAKis. Dr. Cobum.
Mr. COBURN. Thank you.
Dr. Gray, I want to concentrate for a minute. You are familiar
with the National Academy of Sciences recommendation?
Mr. Gray. We have been talking about two today, the Delaney
paradox or children.
Mr. COBUSN. Delaney.
Mr. Gray. Delaney, yes.
Mr. COBURN. And is there an^hing in this bill that would keep
the EPA or the FDA irom following those recommendations?
Mr. Gray. No, not at all. In fact, we would encourage them to
do that.
Mr. CoBURN. Okay. So having given that, I want to move to the
next area which is the nej^igibie risk standard. As a physician, if
one of my patients gets something I want to know that it is not
only not cardnt^nic, but it is not toxic, that it is not embryogenic,
I want to know all those things, and it makes sense to me that we
would want to apply the same standards to all risks in terms of
food additives rather than just one standard for carcinogenic and
another standard for something else.
So if we discount the legal auficulties that the doctor related to,
does it not make good sense to have a negligible risk standard
across the board throughout as put forth in this Dill?
Mr. Gray. I think it makes a lot of sense. In fact, the legal ques-
tion aside, it seems to me that as a toxicologist one of the things
we try to do with pesticides with potential noncancer eiTects is to
find a threshold level for the population below which we don't think
anythinfc will happen to anyone. That sounds to me tike a neg-
Umble nsk when you are below that.
Mr. COBURN. So why is that a hard position to defend if you are
a toxicologist working for the EPA or the FDA?
Mr. Gray. I don't biow. It may well have something to do, as Dr.
Goldman alluded, to questions ot legeil interpretation.
Mr. CoBURN. But one of the whole purposes for this legislation
is to slow down the problems of conflict over legal interpretation.
So in your mind there is no reason not to use a negligible risk
standard throughout the entire range of exposures?
Mr. Gray. Absolutely not.
Mr. COBURN. Okay.
Dr. Winter, do you have any comments in regard to those two
questions?
Mr. Winter. I think from a scientific risk assessment standpoint
we have two different series of ways to estimate risk depending
upon whether the chemical is a carcinogen or a noncarcinogen. 1
can see the interpretation of a negligible risk meaning one tjiat is
insignificant, wmch could be possibly challenged in terms of
noncarcinogenic or threshold effect, so I would hope that if a neg-
ligible risk is defmed in perhaps a further version of this legisla-
tion that it really is speciflc, that perhaps a negligible risk meets
a toxicological determination of a reasonable certainty of no harm,
■ometiiing like that. It is a lot of semantics, but I think from a
l^gsl standpoint it is something that does need to be clarified.
DigilizcdbyGoOgle
50
Mr. COBUBN. All right. Thank you.
Mr. BiLlRAKls. The gentleman's time has expired.
Mr. Waxman.
Mr. Waxman. I have no questions.
Mr. BlURAKls. No questions.
Well, gentlemen, thank you so very much for being here today,
taking time to be here. Again, your testimony was very, very help-
ful.
The next panel consists of Ms. Juanita Duggan, executive vice
S resident of government affairs and public communications for the
fational Food Processors Association; Mr. Dennis Stolte, American
Farm Bureau Federation; and Dr. Steven Ziller, vice president for
science and technical affairs. Grocery Manufacturers Association of
America.
Welcome, and we will start with Ms. Duggan. Your written testi-
mony is part of the record, as you know, and if you can stay as
close to 5 minutes as you can, I would appreciate it. Please proceed.
STATEMENTS OF JUANITA DUGGAN, EXECUTIVE VICE PRESI-
DENT FOR GOVERNMENT AFFAIRS AND PUBUC COMMU-
NICATIONS. NATIONAL FOOD PROCESSORS ASSOCIATION;
DENNIS STOLTE. AMERICAN FARM RUREAU FEDERATION;
AND STEVEN ZILLER, VICE PRESIDENT, SCIENCE AND TECH-
NICAL AFFAIRS. GROCERY MANUFACTURERS ASSOCIAHON
OF AMERICA
Ms. Duggan. Thank you. I will summarize.
We appreciate the opportunity to address the important topic of
pesticide regulation today. We commend your leadership in holdii^
this hearing on proposed legislation to update and modernize our
Nation's food safety laws and ensure that those laws provide strong
protections for public health and the environment.
There is widespread agreement among food industry regulatory
agencies, consumer organizations, and scientists alike that existing
food safety law, particularly the 1950's era Delaney Clause, is out-
dated, unworkable, and must be reformed. However, the Court of
Appeals decision in Les v. Reilly requiring a strict zero risk inter-
pretation of the Delaney Clause and the subsequent consent decree
m California v. Browner now threaten to create a food production
crisis in the United States by denying farmers the use of a number
of important and safe crop protection tools. This potential crisis
confirms the need for legislation to reform the antiquated Delaney .
Clause and give EPA additional flexibility in tolerance decision-
making.
My organization, the Nationeil Food Processors Association, \
strongly support H.R. 1627, the Food Quality Protection Act of -.
1995. It makes essential overdue improvements in our Nation's »
food safety laws by streamlining the pesticide cancellation and sus- -l
pension process, establishing a consistent negligible risk standard ,
tor tolerances in both raw and processed food, assuring the appro- i
priate consideration of benefits, and providing for national uniform-
ity for tolerances meeting current safety standards.
In 1993 the National Academy of Sciences published a report :
that recommended the collection of data on food consumption pat-- ^
terns of inf2ints and children as well as improved surveillance of .'.
DigilizcdbyGoOgle
61
pesticide residues, development of toxicity testing procedures to
evaluate the vulnerability of infants and children, and use of im-
proved methods of risk assessment. H.R. 1627 promotes all of these
goals. H.R. 1627 also permits EPA to minimize the loss of valuable
minor use pesticides and to facilitate minor use registrations. We
support that title as well.
Although we strongly support le^slation to eliminate the
Delaney Clause, it is important to bear in mind that EPA has suffi-
cient authority under current law to regulate pesticide tolerances
in a manner that would minimize the impact of the Delaney
Clause. The potential devastating loss of agricultural pesticides
threatened by EPA is not a necessary result of the Ninth Circuit
Court decision in Lea v. ReUly but of EPA's rancentration and co-
ordination policies. These policies have never been properly adopt-
ed as a regulation and, in our view, should be abandoned.
In September 1992 NFPA and other groups filed a petition ui^g-
ingEPA to rescind the concentration and coordination [lolicies. The
NFPA petition urges EPA to follow the language and intent of the
flow-through provision of the Food, Drug, Etnd Cosmetics Act which
provides that a pesticide residue in a processed food when ready to
eat is lawful as long as that residue was not greater than the toler-
ance for the raw commoditv from which the processed food was
Duule. The NFPA petition demonstrates that the EPA policy was
never envisioned by Congress and is based upon erroneous factual
information.
In February 1995, juat a few months ago, the U.S. District Court
in California approved a consent decree in the lawsuit regarding
EPA's application of the Delaney Clause to pesticide tolerances,
■nd under that decree EPA agreed to a rigid schedule for making
tolerance revocation decisions for up to 80 potential carcinogenic
pesticides in crop combinations, all of which the agency acknowl-
adges pose no risk to public health.
a EPA retains its current policy compliance, the decree will pre-
d|dtate the loss of scores of valuable pesticides. Because of this
eonsent decree, a very real potential now exists for foods to become
more expensive to grow and sell, less tOaundant, and poorer in quai-
ls as farmers lose many of the safe and vital crop protection tools
tDBV need. We have continued to urge EPA to grant our petition
■nd to avoid Ein unnecessary food production crisis in this country.
Hieir current new deadline, which is an extension from the original
deadline, is this Friday, June 9. We hope that they will respond to
the NFPA petition for once and for all £md we will know what the
peitidde r^ulatory policies are going to be for our country.
We also urge Congress to pass legislation that establishes a more
ntiminl standard that recognizes the difference between real and
taegined risks.
In ooncluaion, we commend the subcommittee for opening a dia-
llg (HI pesticide reform, but, if I might, I would like to comment on
icoaple of the issues that were raised by the administration.
Ibe first issue that they raised was the question of how the neg-
%iUe risk B'~ndard would apply to acute risks and whether or not
kmild be consistent with their current policy of reasonable cer-
Unty of no harm. I think from our point of view that is something
DigilizcdbyGoOgle
that is easily handled in report language and there really isn't ne^
essarily a conflict there.
The industry supports this bill because it would move to one
standard and one way of handling raw food, processed food, and all
effects from eating foods with pesticide residues. So I don't think
there is a real conflict there between acute and cancer risks, and
I think we stand ready to work with the committee to make sure
that that is well understood in report language.
With regard to the benefits concern that was raised, it seems
that the administration is not willing to discuss the fact that the
beneflts standard in this bill is current law. It is in Section 408,
and there is no evidence that this benefits standard has ever been
abused by EPA's tolerance decisionmaking. This current iteration
of the bill adds the term, "for consumers, which I think was in-
tended to give it a consumer focus and to make sure that consum-
ers are aiffected by the price, the availabiUty, the (quality, the nutri-
tion supply. This is current law, and EPA uses this benefits stand-
ard now and has since 1954 in making its tolerance decisions for
raw commodities. So fm a little confused as to why they now con-
tend that it would override the safety standard in 408, because if
it were overriding the safety standard in 408 then they would be
making some erroneous decisions.
Mr. BiLiRAKis. Possibly you can expand upon that during tbe
round of questioning, but your time has expired. If you would sum-
marize, I would appreciate it.
Ms. DUGGAN. There is just one last issue that I would like to
raise, Etnd that weis the administration's question about how the
Food, Drug, and Cosmetic Act and FIFRA procedures would coordi-
nate and tneir concern that they would have to go through the &a-
tire FIFRA procedure in order to revoke a tolerance.
I think industry's viewpoint and one of the reasons it supports
this bill that if there were no tolerances, if there were a safety
problem and a tolerance couldn't be established, that there would
also not be a registration so that farmers wouldn't have access to
legal applications and then that food would then be illegal. The in-
tent was to try to link those two so that food that was produced
on the farm would then be legal when it got to the marketplace,
and if that is not what that provision does, I think industry would
have a strong desire to work with the committee and to work with
^e administration to clarify it.
But we stand ready to work with the committee on those issues.
[The prepared statement of Juanita Duggan follows:]
Prepared Statement op Juanita Duooan, Executive Vice President for Oov-
ERNHSNT Affairs and CoBOfUNicATioNS, National Food Processors Associa-
tion
todar and to addreM the inwtntant t(q>ica of pCMticide regulatfoii and food ^.
W« commend the Chairman tbr holding this hearing on prmosed legislation to up-
date and modemiae our nation's pesticida laws and ensure that those laws provide
strong protections for public health and the environment.
NfPA is the voice of tbe $400 billion food processing induatiy on scientific and
public policy issues involviiw food safo^, nutrition, technical and regulatory matters
and consumer afEairs. NFPA's three scientific centers, its sdentista and professional
staff represent food industry interests on government and regulatory affolrs and
clbyG(_V>gIc
68
provide roMarch, technical eervlcee, education, communicatiotu and crisis manage-
ment support for Uie asaociatuKi's U.S. and international members, who produce
proce as ed and packaged fbods, drinks and juices.
NFPA's 600 member compaiiieB have a vital interest in pesticide regulatory proce-
dures and food saCsty standarda. NFPA strongly supports programs to develop eco-
nomical and effiNtive alternatives to pesticides. The food processing industry is mak-
' '"' -«»■—.- -^ develop alternative pest control techniques, including biolof'
a
cultnial and medianical controls, to support integrated pest management (IPM)
programs and to ■■rinimlM pesticide use. NlTA supports Airther research and fimd-
.__ ^*i..» .Mi—i. .. —11 .. ^_. t. r^cilitate EPA regiatration of efEective biologi-
itidde use. It is Unportant to recof^niie, how-
I reduce pesticide use^ the reeponaible use of
1 for the production in the Imited States of
"Delutey Pi
n imgHgnila
gtvaEPAsi,
k standard for pesticide tolerances for raw and processed ft
_ K BuiBdent authori^ u
inlbmuition In tolerance decisions. The Court of Appeals decision in Lea v. Reiily
eonfinns the need for l^islation giving EPA additional flexibility in tolerance dea-
■iimiMlring in light of modem advances in safety testing and risk assessment meth-
oddogy.
NrPA supports reasonaUe ^orts to reform the pestidde regulatory process, ss
wdl aa to resolve the Delanqr paradoK. We support legislation that streamlines the
procedure for mnoving hazardous pesticides ftom the maricet, promotes sound sci-
entific judgment in pesticide tolerance decisions, sssures that tolerance decisions are
< .1 ^ (oqMMure data, requires renewal ti pesticide tolerances to assure
f""r^'y"'* with cuinnt safat; standards, fkdlitataa minor use r^istrations and
pnmdes tot ft"' ' ' ~" "''
Conaistant wUli these oldeettvas, NFPA strondv supports H.R 1927, the Bliley-
* ' ~~ od Qualil? Protaction Act of 1998." ILR. 1627 would make important im-
itt both Ute federal Inaectidde, Fungicide, and Rodentidde Act (FIFRA)
and the foderal Food, Drug and Coianatic Act (PDftC Act). It would streamline the
pestidde cancellatitm ana suspension processes, establish a consistent n^iliglble
rlA atandard fat pestidde tolerances fior raw and processed food, assure appropriate
Gonaideration rf peslicids benefits and provide for national unifonni^ (br tolerances
"-g currant safiriy standards. Moreover, H.R. 1627 contains speciSc provisions,
' ' ', that would require EPA to implement praeedur" "^-'
that peafidda tderaneaa adsquata^ safiwuard tlie heal^ of infants and chil-
uld bdUtata the r^pstratiMi of mincv I
mittee is well aware, on June 29, IK .
see (NAS) published a widely published report on Pestiddes in the Diets oi Ii
and Qiildren. The NAS Report recommends collection of additional data o
dran and that would bdUtata the r^pstratiMi of mincv uae pestidde..
Aa the Subcommittee is well aware, on June 29, 1993, the National Academv t£
~ "Btaoiln-
abili^ of inbnts and childrm, and uae of improved methods of risk assessment to
rwulatory deddons and that special emphaais should be placed on the evaluation
of potential risks to infonts and children. H.R. 1627 would promote both of these
nie growing loss of minor use pestiddes for finiit and vegetable production poses
a serious problem for the food industiy and consumers. Minor uses are not economi-
cally attnctive to the pestidde industry, and there is little incentive for pestidde
pTDOucMV to underwrite the hiidt cost of reregistering minor uses under the data
and foa raquirementa of the 1988 FEFRA Amendments. A growing number of pes-
tidda producers are abandoning minor use r^stratioas, wuhout any conaideraQon
of the relative aaf^ or ben^ta of those uses. H.R. 1627 would permit EPA to mini-
mise loss of valuable minor uae pestiddes by estaUiahing a scientifically defendble
wagHgthU riiic standard, by requiring EPA to base its risk assessments on actual
psstldde uae and residue data, and by providing for appnmriate condderation of
pestidde benefits. H.R. 1627 alao contuns a set ^ important provisions that would
odlitats minor use reglBtiations throu^ extendon <u the p^iod of ocdudve data
nae.axtansfonttf data submisnon deadlines, fee waivers and other provisions.
Althou^ we strongly support legislation to nationalise pestidde tolerance r^ula-
tion and to eliminate application of the Delaney Qauae to pestiddes in procMsed
fcnl H is impmtant to bear in mind that EPA has sufficient autiiwitar under esist-
DigilizcdbyGoOgle
64
of the Delaney Clause, and there im do need for EPA to create a criais throu^
wholeaale revocation of peatidde tolerancea.
The potentiel devaatatiiur Iom of agricultural peatiddea threatened fajr EPA is not
a necesaary reault of the Ninth Circuit dedaloii in Lea v. lUilly but <^ EPA'a con-
centration and coordination polidea. Theoe polidea have never Men properiy admt-
ed as a regulation and ahould be abandoneo. EPA'i eoDcentntion poUqr remiires la-
auance of a aection 409 food additive tolerance «4ienever there is a poMibUi^ that
a pesticide residue might concentrate in a prooossed fbod and its coomnatlon pdicj
mandates that, if a section 409 tolerance cannot be issued (because of the Ddsnejr
Clause or otherwise), EPA must also revoke the section 408 raw product tolerance
and cancel the underiyi^pesticide nitration fbr the poatidde.
In September 1992, NFPA, along with several other groups, Sled a petition urging
EPA to resdnd its concentration and coordination polidea and no l onger to require
separate 409 tolerances for pestiddes in processed food. The NFPA petition urges
EPA to follow the language and intent of the 'Vow-throu^' proviaion of the FD&C
Act, which provides that a pestidde residue in processed food when ready to eat is
lawful as lotig as the residue is not greater than the tolerance for the raw commod-
ity from whi& the processed food is made. The NFPA petition demonstrates Out
the EPA policy was never envisioned by Congress, and is based upon erroneous fiu-
tual assumptions. Extensive data submitted m support of the petition show that ac-
tual residue levels in agricultural commodities and in processed food are well below
raw product tolerances. The petition demonstrates that continuation of current EPA
pcdicy will reauire numerous costiy tolerance revocation proceedings, will force tb«
y to pronibit the use of beneficial pestiddes that pose trivial risks and will
)y reduce the availability and increase the cost to consumers of nutritiouB
fiiiit, vegetable, and grain products, at the very time that FDA and the medical
communis are recommending greater conaumption of these foods to prevent dis-
ease, liius. there, is no sound legal or public policy basis for EPA to continue its
concentration and coordinatiDn poudes, and EPA should not be permitted to perpet>
uate these polides to create an artificial pestidde crisis.
In February 1996, a U.S. district court in California approved a consent decree
in a lawsuit brou^t by California and the National Resources Council against EPA
regarding the Agency^ application of the Delansy Clause to peatidde tolerances.
Under the decree, EPA agreed to a rigid schedule for making ttderance revocation
decisions for up to 80 potential cardnc^enic pestiddes that the Agen^ acknowl-
edges pose only a tM^UgiUe risk. If EPA retains its current policy, compuance with
the decree «rill precipitate the loss of scores of valuable pestiddes. However, the con-
sent decree does not dictate how EPA must rule on the NFPA petition. Tlie consent
decree originaUy required that EPA rule on the NFPA petition by ^ril 9, 1996. Hm
court subs^iuently mnted EPA's request to postpone the date fi^ ruling on the
NFPA petition untU June 9, 1996.
With this background, I will describe the major provisions of H.R. 1627 that we
support,
i. CaruxUation Protxdure.
The existing FIFRA cancellatian process is unduly lengthy and cumbersome, has
no statutoiy time limit, and hampers EPA's abilihr to remove potentially hazardous
pestiddes from the market in a tamely manner. Under current law, EPA must sub-
mit a proposed cancellation notice for review by USDA and undertake a notice and
comment rulemaking process, followed, if requested, by a formal adfudicatory hear-
ing and referral of questions of sdentific fact to a committee of the National Acad-
emy of Sciences (NAS).
H.R. 1627 would streamline the cancellation process by eliminating the right to
refer questions of sdentific £act to an NAS committee, restricting cancellation hear-
ings and establishing a one year time limit for completion of ue full cancellaQon
proceas. T^e registrant and other interested parties would retain the right to make
written submissions during a specified comment period, and EPA would be required
to provide opportunity fbr a hearing, including the right to make documentary sub-
— "~— B and to conduct limited cross-examination on disputed issues of material
tiddes &om the market, and would al _ —
on a fUll and adequate administrative record. The decision to initiate a cancellation
proceeding would require a sound scientific basis and only would be made after
prior notice to USDA, FDA and the registrant
The one year time limit on the cancellation process, indudin^ any hearing, would
enaUe EPA to protect the puUic health by removing potentially hazardous pea-
.yCroogle
tiddea from tha market in ■ tinuij mumar and would peimit EPA to rMttrvo mu-
pension utiont fbr thoM Ebw sLtuationa that involTo genuine imminent hazardB.
i. SiupcnMon.
HJL 1627 would authoriu the Adminiitrator to ianie an emergency lUBpeneion
ordv jraior to a propoeed cancellaticm order provided the Administrator proc oc di tx-
paditimuigr to Imw a p i o p oied caneeUation Mtler. Thia would enable EPA to act
pro mp t l y to nupend ttu regiatntion of a Msttdde that may poae an imminent haz-
ard while aaauring that a fbll liak/beneBt evaluation of the peetidde is initiated
i. ImpUmmtation ofNIKi Rtport.
HJL 1627 would require EPA, PDA and USDA to coordinate the development and
iMylwnentation vt prooadarea to ensure that pesticide tolerances adequately safie-
giuzd Uie health of in&nts and diUdren, bated on the conclusions and reoMnmenda-
Uons wwtfi^H in the report entitied: "Pesticides in the Dieto of In&nts and Chil-
draa" of tibe Nattonal Raseardt Council of the National Academy of Sciences. These
pnceduTM would include cdlaetion of dato on food consumption patterns of infanto
andddli' * .. .,, __ .. _ .. ,
Ibodsmc
ofriaka
VFPK stiviwly supports theae provisions, which would ensure adequate consider-
tiiaa of the suMy of uifknts and children without unduly restricting EPA's scientific
4. NtgUffitU RiA Standard.
Under current law, there ate two different legal stcmdards for pesticide residues
in food. Tolerances &r pesticide residues in raw agricultural commoditieB are issued
under Section 408 of the FFDCA, which contains a general safety standard, no
anticancer clause and requires consideration of benefits. Tolerances for pesticide res-
idues tliat ctnocentrato in, or are applied to, processed food are issued under Section
409 of tiie FFDCA, which contains the Delaney anti-cancer clause and does not ex-
pnaalyintrride for consldoratitm <tf benefits.
In 1967, the National Acaden^ of Sciences (NAS), recommended that pesticide
" " ' --■' - ...... lid ije i-egui^tid on the basis of a single nsg-
he NAS recommendation, H.R. 1627 would
a pesticide residues in processed food and
1 Deaoaoe resiauei " '-' ' ■— '^'-- '-' ■
aofMctlon40a
H.R. 1627 would require EPA to set a tolerance at a level adequate to protect the
pt^dlc health taking into accotmt, among other relevant factors, the validity, com-
pleteaesa and reliability of available data tnm studies of the pesticide chemical, the
nature of any tade efEscto caused by the chemical, available information and reason-
able assumptions eonconing the relationship of the data to human risk and to the
dietaty exposure levels of consumers (and m^or identifiable subgroups of food con-
sumers, iwl iiiting Infonte and children).
A tolerance level fiw a pesticide residue in food would be deemed to be adequate
to pitAeet the public health If the dietaty risk to conBumera from exposure to the
pevtidde is nef^lglble. This would implement the NAS recommendation for a uni-
wna nei^igible risk standard for pesticide residues in food, would give EPA flexibil-
ity to Ignore de minum* vt insignificant risks and would permit the Agency to focus
ito limited resources on the hi|^t risk pesticides.
The definitiM) of "n^ligible tisk" would not identify a specific level of risk that
would be considwed nc^islble or a numerical expression of that level, because
adenoe and the d^ree oif knowledge and confidence in cancer risk assesament is
constantiy evolving and improving, and EPA needa to preserve the ability to keep
pace with the developing science of risk assessment. The Administrator would be
required, however, to set forth by regulation the factors and methods, including
testa which an appropriate for the determination of dietary risk and most likely di-
etaiy eqiomire, for the determination of negligible dietary risk,
EPA would be required, where reliable &te are available, to calculate dietai? ex-
posure oa the basis of the percent of food actually treated with a pesticide and the
actual reeidue levels of the pestidde that occur in food. This would help avoid exag-
gerated and uqjiutified exposure assumptions and would assist in developing more
raalistk risk projeetions.
DigilizcdbyGoOgle
66
5. BenefUt.
H.R. 1627 would provide that EPA may establish a tolerance for a pesticide r
due pooiDg greater than a nwiigible risk if the agency detennines that the rial
raaaonable because (1) the liac to human health from loaa of the pesticide outwei;,_
the dietaiy risk attributable to the pestidde, <2) likely alternative peeticidet or pest
__-__. — .i_j ,_jjg ig the n -'^■■- "- *-- ^'-' '-■-- -—--^ -'-'^'-
.. . , ,_, .__ _ ..w pestidot _ _ _,
quate, whtdeaome and economical food supply, taking into account regional and na-
tional efiiBcts. lUs would aasure that pem&hu tolerance dedsitniB are not made in
isolation, that EPA fiilly considera all relevant tatHon and that a complete risk-ben-
efit evaluation is conducted. In this manner, EPA will be aMe to set reasonable pri-
oritiea and direct its limited resources against the most hazardous and least bnie-
fidal pesticides.
Pood use pesticides provide important benefits for American agriculture. Loss of
pesticides can cause reductions in crop yield and Gum incoine, decreases in apicul-
tural employment and harm to the Internationa] competitiveness of United State)
fumers who must comi>ete with foreign producers wno may continue to use pee-
tiddes that are banned in the United States. Pestiddea also play an essential nde
In providing a «4udeaome, healthy, nutritious and aOMdable food supply. The De-
partment of Health and Human Services <HHS), the Surgeon General, other govern-
ment agendas, and prominent scientific and medical orgonixations have increasing
stressed the value ot a nutritious diet, induding ample amounts (if fnab fi-uita uia
vegetables, in maintaining health and preventing disease. The loss of important food
use pestlddes can result in hdghtened risk of disease causing coganiams in fbod.
food price increases, adverse eEIects on food quality and reduction in the availabil%
of nutritional food choices, partieulariy for low income consumer*. In view of the im-
portant benefits of food use pestiddes, we believe that it is essential that EPA be
permitted to retain the authority to balance benefits against risks in pesticide toler-
ance decisions, especially dnce the Agency's risk estimates are based on multiple
conservative assumptions and extrapolations.
6. Flow-through ProvUion.
NFPA strongly supporte the provision of H.R. 1627 that would retain the
fiowthrough provision of current law. As under current law, H.R. 1627 would pro-
vide that if a tolerance or exemption is in eSect for a pestidde chemical in a raw
agricultural commodity, a residue of the diemical in a processed fbod made trma the
raw agricultural conunodi^ shall not be considered unsafe as long as the concentra-
tion of the residue in the processed food when ready fi>r consumption is not greater
than the tolerance prescribed for the raw agricultural commodity. This provudon
avoids the necessity of establishing separate tolerances for peelidde residues in
processed food and provides recognition of the fact that, in the vast majority of
cases, pestidde residues are reduced and do not concentrate in processed food.
7. Pipeline Provision.
H.R. 1627 would provide that, where a tolerance or exemption for a pestidde
chemical has been revoked, suspended or modified, a food that was l^ally treated
with the pestidde shall not be oeemed unsafe as long aa the pestidde residue does
not exceed the previouslv authorized tolerance level. EPA would retain the powo"
to declare legally treated fbod unlawful, but only on the bads of a determination
that consumption of the legally treated food during the period of its likely avoilafail-
i^ in commerce would pose an unreasonable dietary risk.
This provision would protect against unnecessary destruction of l^olly treated
food, would prevent massive economic loss and marketplace disruption, and would
assure that food producers are not unfairly penalized for use of legal pestiddes that
are sulqect to unpredictable rmilatory action at a subsequent date.
Where a pestidde is identified as a potential carcinogen or other chronic hazard,
appUcable registrations and tolerances may be canceled on the basis of a risk cal-
culation assuming lifetime enMsure. Because food legally treated with such a pes-
tidde would be available in the marketplace for only a relatively short period (i.e.,
one to three ^ears), EPA would be authorized to take action a^;ain8t existing stocks
oiil}r where it determined that exposure during the remaimng period of market
availability posed an unreasonable risk to consumers.
8. Metabolitea and Degradation Produeta.
H.R. 1627 would codify EPA's ezistins policy with respect to pestidde metabolites
and degradation products in food. Un£r that policy, {quantities of a metaboUte
dbyGooglc
ths talcnnM G>r the pracuntn- chemical, or the tolerance apedfically exclude! the
metBlxdite or dcuacUtion product TbiM policj' avoid* the increaaed r^[utration
eeata, adminiatnave burdena and enforcement complexitiea of eetabllahin^ multiple
aapa r a t e ttdenoeea fbr metaboUtea and d^radatum pn>ducts where then u no valid
puUk haaltli raaMn fia- doing ao.
9. tiUtmational HarmtmiMation.
Wtti inoeaaing intamationa] tra e in food produeta, and U.S. govanunent efforta
to raduca trade barrien. It ia impoki«nt that meaningftil steps be taken to promote
intematioaal harmonlcation of peatidde tolerancea. conaiatent with this gcAl, H.R
10. National Unifarmity.
Under current law, atatea and localities may set tolerancea for peatidde residues
in foods that are lower than those established by EPA, or require warnings for food
pmducta containing pesticide reaiduea that are lq;al under Federal law. In recent
jears, a number til statea have set lower tolsrancss for certain pestiddes, creatinE
idgnmcant burdena on intostate commerce. H.R. 1627 would provide for national
onUbnni^ of tolerancea fbr pestlddea regiaterod or ra-MJatered under the com-
prrftmaive aafobr data requiremMila adopted l^ EPA in 1986. This provision would
aacottt EPA leaaerahip in peatidde aafoty dedaiens, and would avoid the conaumer
emfliaion and substantia] Durdena on interatate commerce cauaed by special state
tirieranca requirements. Consumer protection would be assured 1^ limiting required
uoUannlty to peatidde tolerancea supported by fUl adentific teatlng and recent EPA
evaluation.
Under H.R. 1627 any state or local standard applicable to the same pestidde
chemical for which a federal tolerance haa been established would be required to
be identical to the federal standard. States and political aubdivisions woula be pre-
dudad frran drcumvantinK prescribed tolerance uniformih' through impodtion of
warning requirements or outer indirect sanctiona that would pr^kt or penalize the
jHvducaon or sals of food bscause it contains pestidde residues in excess of a toler-
nm> for
public partidpation, that a spedsl state tolerance is justified by compelling local
conditiona, auch as unusual food consumption pattema, would not unduly burden
interstate commerce, and would not catise any food to be in violation of Federal law.
It would be counterproductive fbr Congreaa to pasa legialation eatablishine a neg-
ligible riak atandard for peatidde tolerancea in food while leaving any state tnst dis-
"* ~~"'~ '*" Psdsrslpolicy frse to impose a more restridive standard. A state
agreed a
nould n
application of lero risk standtmi for pestiddes where the Federal government has
v^icitly disavowed auch a atandard and there are no compelling reasons for the
Mate to nave a different standard.
In conduaion, NFPA eonunenda the Subcommittee for opening a dialogue on re-
ftnning our nation's psstidde laws. We stron^y believe that H.R 1627 osers a bal-
meed and focused refon ""*
to reach reaaonable and
■or
II action on this important iasue.
Mr. BuiRAfOS. Thank you so much.
Mr. Stolte.
STATEMENT OF DENNIS STOLTE
Hr. Stolte. Thank you, Mr. Chairman.
My name is Dennis Stolte. I'm senior director of governmental
ralatioDS for the American Farm Bureau, the Nation's largest orga-
nization of farmers and ranchers.
The Farm Bureau enthusiastically supports H.R. 1627. Without
this important legislation, farmers in virtually every State will lose
DigilizcdbyGoOgle
essential crop protection tools which may determine whether some
fanners in some States can continue commercial production of
crops.
The importance of this l^slation is illustrated in the tables at-
tached to my full statement. Table 1 lists each State and the crops
in 45 States which will be affected by the court-mandated interpre-
tation of cancellations we are talking about today. Table 2 gives
more specific information on the percentage of crop acreages af-
fected in selected States and I emphasize selected States; all States
are not included.
For example, triadimefon is used on grapes in California to the
extent of 216,000 grape acres. This product is used for treatment
of powdery mildew. Strict interpretation of the Delaney Clause
means that California grape growers no longer will be able to use
triadimefon. In Virginia, growers of apples treat black rot with a
product called thiophanate-methyl. One of the alternatives to
thiophanate-methyl which will be canceled by Delaney is benlate.
Benlate is also on the Delaney hit list.
There are other examples: 95 percent of Florida's cotton acreage
is treated with acephate, a Delaney hit list product; 76 percent of
the apples in Connecticut are treated with benomyl; 10,000 acres
in New York; 85,000 acres of wheat in Arkansas is treated with
mancozeb for disease control; 100 percent of the apples in Rhode
Island are treated with propargite for mite control; and almost
18,000 acres of peanuts in the State of Virginia with iprodione for
control of schlerodia mite.
Each of these examples when taken separately may seem unim-
portant, but taken collectively they seriously affect a large number
of States and farms. The court consent decree means more can-
cellations and stricter regulation of inconsequential and insignifi-
cant safety risks unless Congress intervenes quickly to inject a
dose of common sense into Federal pesticide policy.
A study which will be released by Auburn University here for
this committee on June 19 hcis found that a 50 percent reduction
in pesticide use which would be brought about partially by strict
Delaney interpretation could also have some real msuor enects on
consumers. The study has found that domestic consumption would
decrease by 4 percent. Wholesale prices would increase by 17 per-
cent. Retail prices would increase by 9 percent. The study con-
cludes that, 'The reduction in pesticide residues in fruits and vege-
tables which would result from a drastic reduction in pesticide use
appears extremely small when competred to significant adverse eco-
nomic effects on producers, adverse economic efTects on consumers,
and possibly adverse health effects on consumers." I would like to
address an issue that Congressman Waxman raised in that the
study had also found that one of the most important effects
Delaney could have would be on low-income Americans who al-
ready consume 20 percent less fruits and vegetables than higher-
income consumers. Delaney severely penalizes this group of poorer
Americans in their efforts to improve their diet and health through
greater consumption of fruits and vegetables.
The Delaney paradox has been addressed by previous speakers,
but this is a very strong concern to the American Farm Bureau in
that Delaney, through the paradox, discourages the registration of
DigilizcdbyLjOClylC
59
newer, safer pestidde products. A second paradox of Delaney inhib-
its farmers in their real efforts to reduce pesticide use through in-
tegrated pest management. Integrated pest management incor-
porates bioloracal controls, crop rotation, and cultural practices in
an overall effort with use of pesticides to control pests. Without
these important chemical controls, however, IPM can no longer be
continued.
Mr. BiLiRAKis. Please summarize, Mr. Stolte,
Mr. Stolte. Mr. Chairman, I will summarize.
It is important to note that while modem technology has greatly
improved our ability to mefisure and detect the tiniest trace of
chemicals in food, we have had no increase in our ability to make
these numbers useful or meaningful in the food policy process. This
does not mean that our current system is broken and in need of
an overhaul. Rather, it suggests the need to carefully change pes-
ticide policy to reflect scientific advancement. The Delaney Clause
has not permitted us to evolve as necessary. Farmers can no longer
wait for next week, next month, or next year for Delaney to be
changed, it must happen in 1996 before court-mandated cancella-
tions occur and are allowed to take effect.
Thank you very much.
[The prepared statement of Dennis Stolte follows;]
Fum Bureau enthusiaBtically supporta H.R 1627. Without this important lagiala-
tion, fiuman in Tirtuall^ every state may loae Maeotial crop protactian toola— ^rod-
ueta idiidi may detarmine whether aome farmera can continue commercia] produc-
tion of aome crapa.
The importance of H.R 1627 ia demonatratad in Tablea 1 and 2 lubmittad with
our written statement TaUe 1 list* each state and the crops in 46 s^tes whidi will
be afEseted l^ a court mandated interpretation and enforcement of ib« Delaney
Clauae. Table 2 givea more specific infiinnation on the percentage of crop acreages
•fiected in selected states.
BACKffitOUND
In 1958, Consreaa psaaed a short amendment to the Federal Food, Drug and Cos-
metic Act (PFDCA) known aa the Delaney Clause. The clause begins with;
"No additive shall be deemed safe if it is found to induce cancer when in-
gested by man or animal . . ."
The goal of the Delaney Clauae is admirable— to prevent cancer-causing agents
from entering our food supply. No one argued with that goal then and no one would
argue the merits of that goal today. Incndible improvements in sdentiSc method,
knowledge and technology has sioca rendered the Delan^ Clauae obecdete. llie
sdenoe on ndiich tbn Ddaney Clause was based upen then— the beet avaiUile
science— -is no longer the best available sdence today. Sbict enforcement of
Delaney's unreasonable lero ttderance standard will tone the loa* at crop protection
products merely because thev are detectable, not because thav ate unaafe.
H.R. 1627 provides sometning American urmers drastieally need; a health-based
standard that r^ecta current practice and «4iicb allows regulators to acknowledge
improvements in residue detemon and our understaitding erf the complex eyatems
which govern heslth and food safMy.
HucE has happened since 1968 which make it inqiOFtant to ptuh for reform of
flie Delaney Clause. There was no Environmental Protection Agm^ (EPA) in 1968.
FIFRA, the Federal Insecticide, Fungicide and Bodgitidde Act, was fint paased I^
Conpeas in 1947. Unlike the Delan«y Clauae, FIFRA has changed and evolved in
DigilizcdbyGoOgle
tandem with sdsiiee and public pcdi^. PIFRA wu miwt racantly changBd in 19B8
and will, we hope, be changed amin with H.R 1627.
Our understanding of cancer baa chansed too and we now know the impatant
role that fruits and vegetablea play in health ana in lowering cancer risk. Amwica'i
eating haUta have changed over the jrean aa newer &rnung techniooea utiUiiiig
crop protection producta nave nude fruita and vegetaUea ^nmdant, antodaUe and
available year-round. Since 1971, our per c^ta conaumptiDn rfvegt^aUee haa risHi
17 percent to 413 poimda. Per capita eonaumption of nuit baa riaen 23 percent to
278 pounda.* Americana are eating healthin' and living longer aa a result.
Agricultural tecbndogf has changed aignificanUy aince Delanqr waa enacted.
Today, fanners are fanning by the inch unng satellite technology and ^obal posi-
tioning mtema. We control pests using a wide varied of new techniquee indudLof
Uoloi^cal contrd, pheromonea, ^»netic redstance, electroatalic ajmiyers, vacuunu
and mai^ other new and azdtang pest control methods. In 1968, theaa methodi
were not available. In 1968, there were no aelf-ptopelled eombinea. Today, tber dtt
the land. Farmen are using radar to gauge true ground speed, laaars to levd tha
land, on-board computers, and many ot£er teehnologica] adnncee. Thirty-sefen
years ago, these new teduiiques were not even concepts. No one then couU possibtf
____!_! _Q the changes that would take place 37 years bter, no more than we can pie-
._ ieyear20__
This returns us to a central Question: What was the intent of Congress in 1968?
Cleariy the intent was not to snackle us to ISSO's teehnolon in perpetuity. While
tbeir Intent may not be clear, the result 37 yean later is dear as defined by the
acted with good intentions in 1968, they surely could not have anoSpated how an
obscure amendment might be plaved out in 1996.
For example, triadlmefon (b^letoa) uae on grapea la one of the peaticides and
crops affected by the recent court decision. Califomia treats 216,O0O grape aem
witA triadimefon for control of powdetr mildew.' Strict intermtation of IMann
means that California n-ape ^rowora can not use trladimdbn. Fanners can contra
powdeiT mildew by api^ying just 2 ounces of triadimefon per acre. The altematife
to tiiaumefbn is sulfur. Faimeis must apply 6 pounds of sulflir per acre to get the
same level of control as using 2 ounces ca triadimefon. Strict interpretation of the
Delaney Clause means increaaed pesticide use on grapes in California, the natira'i
number one grape growing state.
Apple growers in Virginia use thiophanat»-methyl for control of apple scab, bitter
rot, flyspeck, powder; mildew, soo^ blotch and black rot Over half of the apple
acreage in Virginia is treated with thiophanate-metliyl. One of the alternatives te
thiophanate-methyl ia benlate. Benlate is alao on the Delaney liat and cancellation
of both will Simulate grower's ability to manage resistance and reduce pesticide
There are other exom^es of CdUfamia v. Browner cancellations that will affect
fanners throu^out the United States. Here are just a few of the crops that will
be affected by Delaney cancellations:
• 95% of Florida's cotton acreage is treated with acwpfaate. 290,000 acres of cotton
in Arizona and 330^000 acres of cotton on Louisiana are treated with acephate.
• 76% of the wples in Connecticut are treated with benomyl. 10,400 acres of apples
are treated In New York with benomyl.
■ 86,000 acres of wheat in Aricansas is treated with mancozeb for diaease control.
• 100% of the apples acres in Rhode Island are treated with propargite for mite con-
• Alnwst 16,000 peanut acres in ^nrginia are treated with iprodione (or control of
sderotinia blijght. Just over half of the grape acres in Oregon are treated with
iprodione tat control of bunch rat For some crops and peets, there may be alter-
native controls. For others, there will not
Bach of these examples when taken separately may seem unimportant, but taken
collectively seriously affect a large number of states and fanns. And the court con-
sent decree means more cancellationa and stricter regulation of incorisequential aoA
insignificant food aafe^ risks unless Congress intennsnes quickly to iqject a dose of
conunon sense into federal pesticide policy.
There are consumer impacts as well from strictly applying the Delaney Clauae.
In early June. Auburn University will finish a resefwch prc>ject designed to examine
the consumer impacts from policies that reduce pesticide use on miits and vegeta-
1 Economic Reteareh Serrica, USDA.
■NatiDnal Center for Food anil Agricultural Policy, Pcatldda Uie bi U.S. Crop Production.
AlKi M* Table 3.
61
Ues." AlCCordiiv to th« ■tu4r, the fbUowing impact! rapreMot the etbcta of a 60 per-
cent redudaon in pMtkide um:
• Domeatic production would decroaae by 6 perc«nt;
• Bxporta would daeruaa by 10 po-cent;
• Importa would incraaaa by 3 percant;
• Domaatic conaumption would decraaae by 4 p«re«nt;
• Wboleaale prieaa would increaae by 17 p«rc«nti and
• Retail prieaa would ineraaaa by 9 peroant
From a fbod aabty atandpoint. the atudy fVuther eondudaa that:
". . .tba reduction in paatkide radduea in fruit and v^etablea iriikh would
result fr«n a draatic roduction in peatidde uae appaan extromely amall
conwand to aigniflcant Advme aconomic elbcta on producera, adveraa «
-jE.^ 1^ gnj poeaihly advene health allacta on a
Periupa moat important are the effecta Delaney will have on low income Ameri-
cans, conaumn who already eonaume 20 percent leaa fresh fruits and vegetables
than hi^er income conaumara.* Delaney aeverely pensliaaa this group of Americans
in thedr effinta to imprvve their diet and bealui through greater conaumption of
fruita and vegetables.
FARM bureau's OOALfi
In tmns of the broader lagialative package embodied in H.R. 1627, Farm Bureau
is supportive ot the fiJlo wing two goua. Pint, is the need to reserve the diffiBrencaa
between FIFRA and the FFDCA as they relate to pesticide registration and the tol-
erance-setting proceaa. llieae proviaiDna would align peaticide iMulation with rac-
ommendations made in the 1087 National Academy of Sdencea (NAS) repOTt, "Regu-
lating Peatiddes in Food: The Delansy Paradox.* The "Delaney Paradox,'* as de-
acribed in the NAS report, stems from the contradictory regulation in the risk/no
benefit Delaney Clause vs. tba risk/benefit standard in FIFRA. llie "paradox" in ttie
law is that strict compliance to the Delaney Clause prevents newer, ni&r but mi-
nutely carcinogenic peatiddes from reachin g far ms to replace oldOT, riskier pes-
ticides. Coordinating eflbrts in PIFRA and FFDCA is an eaaential component for
ILB. 1627 reaidvas this problem by repladng the EUlaney Clause with a single,
■m^igitila risk stsndard for peatidde residues in both fr«sh and processed foods.
Tbu sin^e standard will give the EPA the flexibility it needs to accommodate fii-
ture devdopments in scisnce.
Our second goal is the need to consider a pestidde's benefits in the resistralion
and toterance-settiiw process. The most eompeUingreason of the benefits from pea-
tidde use are deacribed by Nobel Isureate Norman Boriaug:
"... if U.S. brmers used the agricultural technolc^y of the 1930*8 and 1940*8
to produce the harveat of 19Eo, they would have to convert 76 percent of
the permanent pasture landa in the U.S. or 60 percent of the American fbr-
The benefita of pestiddes accrue to all of sode^, not just to farmers, and their
consideration in pestidde reculatory decisions is criticsl ntr 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 ;ear.
A nsk-only approach to pestidde regulstion does not reflect the contribution of
pestiddes to our food supply. It is important to note the benefita sode^ derives
from the safe and judidous use of pestiddes. Research frton Texas A&M Universi^
entitled The Economic Impacts of Reduced Pestidde Use on Fruits and Vegeta-
bles'" catalogs the benefits derived from pesticide use. These benefits include:
>C. Robort Taylor, "Eeonnnie Imracts and EnvlionnMnta] and Pood Safety Tradeoff! of Pea-
tidde Vt Keduction on Pniiti and Vegetables.'
«Stev«n M. Lulz. David M. Smsllnood, Jamei R Blsylock, Man Y. Hama, Chatuw* in Food
ConsumptioD and BxpendlturM in Low-Incoma American Houtehsldi During the ISSO'a, USDA/
<^RS Human Nutrition InftonnaUon Servieo, 1993.
■Ronald D. Knulnn, Charlea R. Hall, Eiiward 0. Smith Samuel D. Cotner, John W. Miller,
1c Impacts of Reduced PeMiGide Use on Fruita and Vecetablea, 1993.
DigilizcdbyGoOgle
> PeaticidM incTMM yiddi and allow food to be produoad on leaa land. Land th«t
would otherwise be needed for food production con be devoted to wildlife hatntU
and other beneficial uaea. Pesticides also allow envircHunentaUr fragile landi to
be idled. Fewer fanned acres reducaa the amount of watw neeaed tor irrigatum.
• Peeticides prevent soil erodon resulting fma increased cultivation to contnl
• Pestiddee reduce farm coata. Reduced casta allow us to compete in world market).
Lower Gu'm coats also translate to lower food coats whicn encourage consump-
tion of foods imjMrtant to health.
• Pesticides allow food to be grown domestically, rather than depending on importi
where we have Uttle or no control over food production methods,
• Pesticides improve the quality and storability of fbod. Corsutomi can eaqwct
pMiBhability at the marketplace as a result of peet infiratation and consumv
Flection oTproducta with poor appearance and quality if farmers ore forced Is
oniitrarily reduce pesticide use. Consumers can expect poor quaUty foods if tlin
are ^ically storea for long periods, like apples. High quality fboda ore eseentij
for meeting export standarae as well. Customer eountriea will rt{ject U.S. prod-
FARM BUREAU POUCV FOR REDUCINO FEanCIDE USE
In the seven years since Congress last passed amendments to FIFRA, the critia
~~Bticide use have opposed reforming Delaney and have advocated tigfatcr cod-
attd regulatory activity as the primaiy avenue for improving fbod safety sod
of pesticide use have opposed reforming Delaney and have advocated tigfatcr
trols attd regulatory activity as the primaiy av ' " ' "~" '-' --*-•
for achieving further reductions in p^Aidde use.
According to National Agricultural Statistics
urea, total pestidde use has trended downward since
According to National Agricultural Statistics Service surveys and EPA sales Bg-
___ ..._. ^_-j L__, J.J J J ^_.. ,n<,^ Not one of agricultures
measures that will further decrease pestidde use. outside of stricter regulation snd
maintaining the Dalaitey Clause.
Farm Bureau's message and goals have remained constant and dear during theae
years. Some of the ideas and options that Farm Bureau has advocated dunng tiw
post several years that will reduce tota.' ■' "■ - ^ > j •- ■- « ■ -■■ -
native peat control products such as hi
resistance management induditift the u
and breeding for host plant resutance.
ticide application technology and improved applicator training in reduced u
ods will also aubstantiall/ decrease the need for pestiddes without burdensome new
r^ulations aimed at limiting a farmer's control options.
Already much is beins done. Last April, at the National Symposium for Integrated
Pest Management (IPM), over 200 research projects highhgbted the vast array irf
new ideas that will help farmers reduce total pestidde use. Our goal is to build
upon the viwt and impressive research network anchored through the land-grant
universitT system and create new farming techniques that reduce pestidde use.
Faun Bureau policy for reducing pesticide use supports:
1. The widespread promotion and use of IPM aa a method of redudng
costs, risks, lialnlity and total dependence on farm chemicals.
2. Continued research and dewlopment of pestiddes which de^de more
rapidly, are less environmentally pcmstent and are compatible with accept-
ed IPM practices.
3. Increased biological peat control research to determine where biological
G«t control measures can provide practical and feasible substitutes for non-
olosical pestiddes.
4. A beiMfidal insects category in USDA's competitive grants program.
6. Expanded educational w^vms to encourage the widespread adoption
of IPM and the addition of^IPM instructitm as part of pestidde applicator
training programs.
6. Improved training programs on the proper handling and safe use of
pestiddes to ensure tne safety of handlers, applicators and agricultural
workers.
7. The national efibrt of the IR-4 program for which we have urged Con-
gress numerous times to appropriate needed funds.
Congress and EPA can also create incentives for farmers to reduce pesticide use
and to find safer alternatives. Incentives should include:
■ Streamlining the EPA registration process for newer, safer producta. The current
registration process is long and eipensive and is a disincentive to bring new
iiizcd by ^jO'
iogle
1 the taaAet Safer product* ahould have «n euier and fiuter reg-
a path. EPA hae recently initiated a program to expedite thia proceu,
«4uch we Delieve ia appropriate and commendable.
• EPA should deregulate non-chemical controla and peaticide producta generally re-
gwded a« aafe TgRAS).
CONCLUSION
There is a lot of good news for the American food
the supply of food
ivide sufBdent evidence and argument
■Ulilgr to meaaure or detect the tinieet trace of chemicala ii
increaw in our abili^ to make theee number* useful or meaningful to the food pol-
icy pnceas. This reaults in periodic food safety scares. This does not mean that our
eurrent ^tem is broken and in need of an overhaul. Rather, it suggests the need
to carefully change pesticide policv to reflect scientiGc advancement. The Delaney
Clause has not permitted us to evolve,
>, as necessary.
ir and are allowed to take eRm.
!t 1996 before court mandated ci
Tsble 1— Stsles ind Crops Affected tqr Odineir Clause Cancellitions
!Wi
CwUlKlld
«■ _ . .
Cfltlon, ScTbuni. TomMoM. Whwl.
tatt
Cotton, Citnii. GrtpM.
ita, .
Cotton. Applti. Grtpn. Rin, Whell.
S?" - -
Cotton, Appm. &.PM, Cittu.
i?"
AdPtes. TmitOK. G>*pH.
JncicK- -
Apple). romitoM.
S*
Appln.
"Ml ...
Cotton, Citnjs. TomiloM. SortMnt. VMmI. Su£*teini.
!?■ - -
Cotton. AppM. twnimi. GripM. Sorlnini. Wittt.
J? --
PinHppM. SuMn:.«.
!»- -
Appto).
S" —
Apple), rmito.). Mxit.
*«
Appit). Tanitoei. Wheat.
s
Applet, Tomitoei,
s<« .
Apple). &ip«.
»««»-
Apples, Tomitoev Wlie.t.
S««i — -
Cotton, Wnx. SoflKanj, Wheit, Suiircine.
!*t
ipptes.
!>»« . . .
ipples, TomitOM,
^wuat, . ...
Apple), Tomltoe).
ga-- -::::-- -
Apple), Gripe), Tonalot). Wheel.
IpplK.
fewwi
Cotton. Soytieeni, Rice, Wticil.
^W
Cotton, Apples. Gtepes, Rici. Tomitoes. Wheel.
fchWi
Birler. Oit).
2«H.i«<hn . . ,
Apple..
t*«l
Applei, ToniitDH, G(ip*). Wheit.
^fcw - --
Cotton.
*.Trt „. .
Applts. bepes. ImHIoes. Wheat
**C«I*M -
Cotton, Apple), Gfipe), Soiftein). Wheat. Peanuts,
»«DM> ., . _
Sofbetns, Birli). Wheel.
?• -- - -
Apples. Capes. TomiMs. Wheel.
ijMsi . . _
Cotton. Apple).
hpa.
Apples. Giapes.
FknvtniM-
Apples. Gtipes. TometDes. Wheat.
IMbM
*W«).
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TaUe l-Stitet ind Crops Mfectsd by Oelirwy Clause Cancellations— Continu«d
suu
dmiMKtM
CotMn, Apples, Gfjpes, Soytaans, WwjL
Conw, Applet. TMiitMS. SoyMtns, WheW.
Wisconsin
Applts. TonalMj
III Cwlti <■ FM M «|NMnl <>olicr. TMiciiH Uii n US. dig PiMmIim."
TaUe 2— Mfecttd States and N
%
ChMicil
cn»
SM.
?
VmTrutM
Ibi
Cotton
Fl
U
95%
£9
47,IK5
m,2S0
U
40
163,200
DC
ID
150,100
lA
3t
330,™
MS
242,172
CA
77J50
TX
143,400
SivbHns
MS
70,000
lppl«
CI
GA
10.BOO
2.919
I.IH
^"°^ ""
HD
1.721
Dt
412
X
2.556
OH
It
2.660
NY
20
10,400
CA
U
4,452
Cilnit
R.
s
29.160
Gripn
HD
61
V
713
543
NC
J7
192
CA
S
59,004
VM
2,170
RlH
AR
2B
366,400
lA
H
86,600
TX
14
19,140
MS
S
13,750
TomahM
VA
100
3,400
PA
90
4,950
CI
65
244
IL
30
746
Fl
IS
9,270
Captan
Grim
MO
100
1,150
456
NC
w
¥A
w
U92
OH
23
460
HY
IE
5,2M
CA
8
54.4B6
IhMlcarli.
Cotton
AL
70
265,600
FL
6i
32.17S
lA
*i
374.100
MS
3S
511,252
OiiMthlsjn ,
CPttM
AZ
MS
19
23
60.750
309.442
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X
amiul
c™*
SUM
T
tooI'NM
LtaUAMM
LA
15
130,500
35535
Fl
10
4.950
U36
MO
10
32.600
9.840
HC
10
37.700
11.687
M
80.750
19.600
Aa
am
AZ
18.870
33,777
U
83,878
I4U34
FL
5.836
im
*
Mt,
ND
1
26,500
26,500
HE
300
460
(Mb
HE
2.200
2i00
WMt
MS
30.000
48,000
HT
13,200
26.400
M
65,000
136.000
IN
25,200
40J20
VA
18,550
29.680
HD
114.200
182.720
Citnu
a
116.720
441J02
CA
12,335
17,799
TX
SSO
791
AZ
1.850
2,670
UN ., ,..
Cottm
MS
161.148
24.217
lA
104,400
15.660
CA
99,450
24,266
AZ
38,250
9,333
n
2,475
371
Wnt
OR
Z7
13,365
3,609
WA
27
9.342
2,522
ID
10
1,780
1,406
f
Appitt
Rl
100
623
997
UT
»
4,«I
6,489
CI
68
2.612
6.489
NH
62
2^90
3,458
HJ
S7
2,508
5,944
HV
57
29,64D
70.247
HI
25,US
61.354
IL
47
l,D9l
9,983
WA
7
nm
26,544
Citni)
a
6
35,016
71.783
M
2
4,93*
11.817
Gfipn
CA
33
255.6S4
406.538
Mh-mUql
Apillw
PA
62
14.880
3,535
10,267
742
MO
H
sc
SI
2.088
2,861
VA
53
10.494
10,284
ME
51
3.719
2,008
m
51
1,884
1,017
vr
SI
2.411
1,302
w
40
20.800
16,304
CA
16
5.088
5,281
*i-
AlWlM
SC
31
1,116
201
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TIM 2-«ftcM StMs tMJ NMRbef ami Pwcant Acm Tmted bjr SM n i Result of Oelaner Ctiw
Cincdlitions— Selected Stito-Continued
-„
Cn«
SW
M
».,™
LMHtMM
WA
2i
IS^
5A1
OR
10
1.310
311
M
19
10.165
m
H
19
473
ft
IM
19
1.131
m
11
19
Hi*
311
CA
16
s.on
m
GripH
TX
90
3.SU
u
HI
76
6.360
IM
U
7S
3J75
1,215
MO
It
m
IK
DC
70
364
41
NY
e?
22,110
4.4a
m
40
12.400
m
CA
33
216J4S
3Ult
MaM
MS
22
55.000
sm
lA
22
37.400
m
GA
It
63,000
im
Al
It
17.100
i.nt
AR
10
»5.000
w
VA
10
2S.500
3«
31,000
]«0
Gupu
15.610
2.142
24JI31
pnxMM
OR
SI
la
VA
34
499
m
NC
34
177
a
sc
34
92
m
AR
32
704
w
CA
15
9t.3tO
il,6U
Piinuti
NC
19
29.070
11,69
19
17,670
;,«
K\a
AR
12
165.600
».«
MS
12
33.000
\m
HO
8
8.960
t,w
lA
6
37,200
I9,!l(
IX
6
21.060
ll.lf2
SOURCE, HiMnil Ca*M Iv FM M Woilmnl Niti, "PMIclh IHt la Uj. bw NdMdaa"
MBF PuMic Polci Dimlw
Mr. BlLlRAKIS. Thank you ao much, sir.
Dr. Ziller.
STATEMENT OF STEVEN ZILLER
Mr. Ziller. Thank you, Mr. ChairmEin.
I'm Steve Ziller, vice president of Bcientific and technical affairs
at the Grocery Manufacturers of America. Our association rep-
resents companies which manufacture approximately 85 percent of
the grocery products in the United States, and their members' an-
nual sales exceed $360 billion.
GMA strongly supports H.R. 1627, the Food Quality and Protec-
tion Act of 1995, which was recently introduced by Chairman Bliley
and Chairman Roberts as well as more than 60 other original co-
sponsors, emd I would also note that a majority of this committee
h£is cosponsored that legislation.
For almost two decades GMA has supported the concept of revis-
ing the statutory provisions governing Federal regulations of pes-
gill zed DyK^i
oogle
67
tcides used in the production of food. This bill represents a marked
mprovement over a number of proposals for the regulation of food
ise pesticides introduced in Congress during the last decade.
Changes in science and technology since the 1950*8 made it en-
irely appropriate to review and revise the current statute to en-
ure continuation of a high standard of safety and also to make the
>TocesB of establishing residue tolerances more efficient and effec-
ive.
Furthermore, the 1992 Lea v. Reilly decision and the California
rersus Browner settlement have complicated EPA's task of apply-
ing the statute in a rational and scientifically defensible fashion. A
whole range of pesticides are expected to be canceled in the next
few years as a result of these court decisions.
The bill before this committee would make a much needed
change in the Act by establishing a negligible risk standard for pes-
ticide residues in both processed and unprocessed foods. The Na-
tional Academy of Sciences recommended such a change in 1987 in
a report on this subject.
Because these and other proposed revisions of current law would
^ipropriately modernize regulation of food use pesticides, GMA en-
dorses H.R. 1627. I would just like to briefly summarize some of
the key provisions of the legislation.
N^figible risk standard. This certainly is a modification of cur-
rent law. The standard in this bill was recommended by the NAS
and has been discussed by a number of people today. I certainly
think that the NAS report on children's exposure to pesticide resi-
dues would allow EPA — ^in fact, mandate EPA to incorporate their
recommendations for children zmd other sensitive suopopulation
poups. Equally important, the current bill retains the long-stand-
ing practice of considering health, nutrition, and other consumer
benuits, including the impact of the loss of the pesticide on the
availability of an adequate wholesome and economical food supply
when determining whethei* a tolerance should be permitted for a
pesticide in food.
This bill also properly retains the provision that raw commodity
residues appearing in processed foods are lawful so long as these
residues have been removed, to the extent possible, with good man-
ufacturing practices and the concentration of such residues in the
>^dy-to-eat form of the food does not exceed the raw product toler-
ance.
GMA applauds the provision of the bill that precludes States
from issuing different tolerances, warning label requirements, or
()ther limitations on residues in food products of pesticides reg-
istered or reregistered after April 25, 1985. Once a Federal pes-
^dde residue tolerance is scientifically established, that determina-
tion should apply uniformly across the States and local govern-
ments with rare exception.
In sum, Mr. Chairman, GMA supports H.R. 1627. This bill rep-
tesentB a balanced response to recent difficulties encountered in
EPA tolerance setting activities. Under the proposed legislation,
r^ulatory decisions will better reflect contemporary scientific infor-
mation about the risks and benefits of pesticide use in food produc-
tion.
Thank you.
DigilizcdbyGoOgle
[The prepared statement of Steven Ziller follows:]
Good morning. I am Dr. Steven Ziller, Vice Preaident for Sdenee and Technicii
Aftain, for the Grocery ManuCacturera of America, Inc. GMA ij the natiooal trade
aaaociation repreaenting companies, which manufacture and maricet branded gro-
cery producta, comprising the lar^rest volume (86 percent) of the food and groeei7
items sold in the U.S. Member company annual salea exceed $360 billion. Gf£^ sup-
ports H.R. 1627, the "Food Quality Protection Act of 1995," which was recently in-
troduced by Chairman Bliley and Chairman Roberts, as well aa more than 50 other
original cosponaors. This legislation has also been introduced in the last two Cod-
Doet two decades, GMA has supported the o
B governing federal r^ulstion at pestiddea used in the pnx
witn tnat, we applaud the efforts of the sponaora of H.R. 1627. Tbu oui represenn
a marked improvement over a number of proposals for the r^ulatioQ of fbod-uie
pMtiddes introduced in Congress during the last decade. GHA supports passage of
this I^islation.
Changes in science and techndogjr aince the 1960s make it entirely appnipriile
to review and revise the current statute to ensure contintiation of a high standaH
of safety, and also to make the process of establishing residue tolerances more effi-
cient and effective. Many of the advances in analyt^ chemistry and the sdenee
of quantitative risk assessment could not have been foreseen Mwral decades ago.
Furthermore, the 1992 Lea vs. ReiUy decision by the U.S. Ninth Circuit Court of
Appeals, which turned back the Environmental Protection Agent^s policy of dii-
regarding de minimis risks under the Delaney Clause, and the more recent Cal n.
Browner settlement accepted by the U.S. District Court for the Eastern District of
California have complicated EPAs task of appljring the statute in a rational and sa
entifically-defensible fashion. A whole range of pestiddes are expected te be can-
celed in the next fi>w years, as a result of these court decisions.
The bill before this subcommittee would make a much needed change in the Act
by establishing a ne^igible risk standard for pestidde residues in both processed
and unprocessed foods. The National Academy of Sdencas recommended audi t
change in a 1987 report on the suhp'ect Because these and the other proposed revi-
sions of current law would appropriately modemiie regulation of food-use pestiddeB,
GMA endorses H.R. 1627. We would like to add the following commenta on specific
elementa of the bill. |
DISCUSSION
NegUf^te Riak Standard
As previously mentioned, the proposal would adopt a negligible risk standard as
the basis for establishing safe pesticide residue leveJs in food, a modification of cuT'
rent law recommended by NAS. The bill spedfically addressee the concerns eK-
preased in the recent NAS report on children's exposure to pestidde residues by
mandating that EPA consider these and other sensitive population graiuiB.
The sponsors of the bill have correctly recognized that the same eatety standard
should apply in setting tolerances for both raw commodities and procrased foods-
Moreover, the standard is fonnulated in such a way aa to allow for the consideratioP
of new sdenti&c knowledge and innovations in productian techniques, unlike other
proposals that had sought to replace the Delaney Clause with equally rigid and un-
sdentific criteria for evaluating safety.
Equally important, the current bUl retains the longstanding practice of consider-
ing the health, nutrition, and other consumer benefits— including the impact of the
loss of a pestidde on the availability of an adequate, wholesome and economical food
supply— 'i^en determining whether a tolerance should be permitted fbr a p " "~
... food producta. Pesticides are highly important to the production of food in tbi>
country. These ehemicala indirectlj; promote public health by controlling disease and
damage to food, and therdqr providing nutntious and low-cost products for Amer-
ican consumers. "Hie NAS recognized that the benefits of pestidde users are an im-
portant consideraUon in tolerance dedsions. Under the negligible risk standard set
0»rth in the bill, EPA will be able te focus ita resources on the most important isBuet
and not waste valuable resource! on insignificant or negligiUe ones.
dbyGoOgle
rofemnoea fi>r Proonmd Foodi
to as tba "flow thmu^ proviaion') providaa that raw commodity radduaa apMaring
in proMaMd fboda are uwfiil so Ions «a thaae naiduM have been removed to the
extent poaaible with good manu&ctunng practicea and the concentration of auch rea-
iduM in the ready to eat form of the food doce not wiceed the raw product tolerance.
The Bow throu^ proviaion recognises that peatidde residues normalljr decreaae dur-
ing proceaaing, and HJt. 1627 property retama thia provision.
Meaaurementt of Dietary Expoiurt
Actual levels in raw agricultural Mmtnoditiea and processed fboda are substan-
tially bdow the toleninees that have been establiahed for raw products under sec-
tion 408 ci the Act Tbia occurs because EPA exposure calculations are baaed on un-
duly conservative assumj>tionB about peatidde use and the extent to which process-
ing reduces any remaining reaiduea. Arolication tS peatiddee to food crops is per-
formed to minimise residues at time en harveat, and poat-harvest proceaaing gen-
erally reduces those reeiduee even further. Under the bill, the agenn would cal-
culate dietaiy exposure levels on the bssis of sctual dato whenever possible.
Food Product* in the Piptlim
In the event that s tolerance is revoked, foods from crops lawfully treated with
the affected food-use pestidde should not unnecessarily be sulnect to seizure and de-
struction. Unless EPA determinee that consumption A a legslly treated food would
pose an unacceptaUe risk during the depletion of existing stocks, there is no jus-
tification for the serious maritetolsce disruptions and economic losses that would
apply that decimon sgainst products "in the pipeline," l^e bill correctly exempts
such food products.
National XJjiifiirmity
GMA applauds the provision of the bill preduding states from issuing different
tolerances, warning label requirements, or other limitations on residues in food
products trf" pestidoes registered or reregistered after April 25, 1985. Once a federal
peelidde residue ttderance is established, that determination ^ould apply uni-
fbrmly. Otherwise, differing stote standards, whether they are impoaed directly
ttirou^ tolerances or indirectly throuc^ Isbieling requirements, will significantly
burden interstote commerce. In the unfikely event that spedal local conditions ne-
cessitate variances from the uniform federal standard, stotes could petition EPA
Streamlined FIFRA Cancellation Procedure*
GMA supports the procedural revisions of FIFRA which allow expedited suspen-
sion and cancellation of pestiddea when warranted, as weU as the requirement that
existing residue tderances be reviewed in conjunction with the review of pestidde
registrations under FIFRA. Eliminating dangerous a^cultural chemicals in an ex-
pedited fashion would serve to better ssfeguard pubhc health and maintain contin-
ued consumer confidence in the safety of the food supply.
Condution
In sum, Hr. Chairman, GMA supporte H.R 1627. This bill rniresente a balanced
response to recent difBculties encountered in EPA tolerance-setting activities. Under
the proposed le^slation, regulatory dedaions will better reflect contemporary sd-
entific information about the risks and benefite of pesticide use in food production.
Mr. BiLiRAKiS. Thank you very much, Dr. Ziller.
Ill change the process very briefly at this point and recognize my
colleague from New York, Mr. Towns, for his questioning.
Mr. Towns. Thank you very much, Mr. Chairman. I will try not
to use up the 5 minutes. I appreciate the speciftl consideration.
Let me just ask all of you this one question. If Delaney reform
is not enacted this year, what would be the impact on companies
and agricultural interests that all of you represent? I would like a
response from each of you.
Mr. Stolte. For some farmers — I'm spealting for agricultural
producers — I think there would be alternative pesticides for the
ones that are scheduled to be revoked under Delaney; but for other
DigilizcdbyGoOgle
70
growers there would be no good Bubstitutee for those pestiddes,
and in some cases we have strong information to indicate that com-
mercial production of some crops would not take place. Farmers
would either be forced to give up production of that crop or be
forced to grow a different crop for which they had an effective crop
protection tool.
Mb. Duggan. For the food processing industry, the vagaries of
the marketplace and the vagaries that would be associated with
the production of the crops would extend into processing those to
the marketplace, and we would have a tremendous amount of work
to do to ensure that we don't have illegal residues on any of the
foods that we produce. Thero would be a huge amount of testing
procedures that would have to be implemented in addition to sim-
ply the additional costs and the potential unavailability of certain
commodities.
The responsibility for ensuring that a food is under tolerance is
at the manufacturing level, and that entire program would have to
be implemented to ensure that none of these 80 crop pesticide com-
binations, should they be canceled, were present on food products.
Mr. Towns. Thank you.
Mr. ZiLLER. I would agree with that, and would also add the one
additional factor which is very significant, which is, once these
things get into play £is far as EPA banning things, you get a tre-
mendous reaction — overroaction, in the media which causes a tre-
mendous problem for food manufacturers, their products, their
brands, the confidence of the consumers, and so forth. I think it is
a real serious thing. I would certainly hope that legislation could
come forwfird to prevent that sort of banning.
Mr. Towns. Let me thank all three of you for your testimony.
Thank you, Mr. Chairman. I yield back.
Mr. BiLlRAKlS. I thank the gentleman. His time has expired.
Mr. Whitfield.
Mr. Whitfield. I would like to ask Ms. Duggan a question.
I had earlier fisked Dr. Goldman in the first panel about the peti-
tion of the food industry relating to concentration and coordination-
policy. I was just wondering if you would have any additional com^
ments about the process that is going on there and what is your'
view as to why it is taking so long.
Ms. Duggan. Well, yes, I would love to answer that question^
Thank you.
The Nationftl Food Processors Association petition that was sub"
mitted in September 1992, almost 3 years ago, made the case that'
we think EPA has been misreading the statute for many, many
years in the way it has regulated pesticides. It argues that Con-
gress never envisioned pesticide residues to be treated as food addi-
tives, something that was added directly to the food supply, and
never envisioned that they would need a food additive tolerance,
that the raw commodity tolerance should have sufficed to make the
processed food legal as long as the residues were under the raw
product tolerance.
EPA, over the course of the years, as the science evolved and de-
taction methods were improved, developed a theory that there was
some potential exposure associated with concentration in the proc-
igle
71
eased form, that if you, for instance — actually, I have a chart here
that might help explain some of this, as you can see it.
For instance, if you took a tomato and turned it into tomato
paste, the residue might concentrate, and not necessarily con-
centrating above the raw product tolerance but by virtue of con-
centration, would require then a food additive tolerance under sec-
tion 409 where the Delaney Clause is present. So they began to re-
quire the concentration data, and in fact there was some data that
some of these things do concentrate. They also began to evaluate
foods on a processed level as opposed to the ready-to-eat form for
consumers. So they would take tne tomato paste and since it con-
centrates, the agency would require a 409 tolerance, not recogniz-
ing that nobody really eats tomato paste; they eat pizza sauce or
they eat pizza uiat has been reconstituted, euid therefore concentra-
tion may not actually ever been an issue for the consumer.
So we believe that concentration, No. 1, doesn't really have a sci-
entific basis and that the flow-through provision should suffice to
make all of these processed foods legal under Section 408. In addi-
tion to the concentration policy, when EPA chose to require a Sec-
tion 409 tolerance on a processed form and if the Delaney Clause
came into play, which it has with about 80 combinations of crops
and chemi^s, then they would cancel the 409 and the 408, there-
by driving Delaney back into the system into the raw product com-
modities.
We have ai^ued that concentration and coordination should be
rescinded and that the flow-through provision and the ready-to-eat
provision should be given new life. Virtually all of this potential
crisis associated with this consent decree could be mitigated, and
if you ever had a situation where the EPA really thought there was
a food safety concern with a processed product, thev could set that
tolerance under a completely different section of the law, Section
406, where they have the ability to prohibit adulterated food. A tol-
enince could be set there, and there is no Delaney Clause in that
part of the law.
So the NFPA petition with that legal framework was submitted
3 years ago, and EPA did not respona to It. In the meantime, a pall
that has been cast over these combinations of chemicals and crops,
and the marketplace is waiting, farmers are wondering whether or
Hot if they treat their foods this year the processed fonn will be
legal in the future, and the regulatory uncertainty is very, very
great.
Mr. Whittield. Is there anything in this le^slation that would
dear up the contradiction between sections 402 and 408 and 409?
Us. DUGGAN. "niis legislation is actually a better alternative
than trying to do this administratively, because as long as the
Qelaney C&use is in place you are going to have some difficulty in
n^ating. You will still have two sepEu-ate standards for raw and
processed foods. You will then also have a conflict with FIFRA. So
^ legislation would clear up all of these issues.
But our point is that EPA does have discretion right now to miti-
gate most of these problems and has not chosen to respond to the
Ptilicy issues we raised. The consent decree that they agreed to on
'sbmary 7, 1995 requires them to respond to the NFPA petition,
and their originfd date was April 9. They went to court and got an
DigilizcdbyGoOgle
72
extension for June 9, which is this Friday, and of course we have
no idea how they are going to respond on June 9.
But the interesting thing about the way the consent decree was
written is that the plaintiff, Natural Resources Defense Council,
can reopen the litigation and quash the consent decree if it dis-
agrees with the policy issues established in their response to the
petition, so there is ^most a veto process there, and so EPA is be -
tween a rock and a hard place. Either the eigency denies the NFPA
petition and goes through the expedited schedule of reviewing and
then canceling the Delaney tolerances or they grant the NFPA peti-
tion and try to mitigate this. In either case tiiey will be taken to
court. If they grant the NFPA petition they will be taken to court
on one set of policies and one court case. If they don't grant the
NFPA petition and they cancel all of these tolerances they will
have litigation on every one of them extending for years into the
future. So from a cost and a taxpayer standpoint we clearly think
they should grant the NFPA petition.
But the best of all possible worlds is to pass this piece of legisla-
tion, and that would obviate this entire process. There would be
r^ulatory certainty and you would have a science-based standard
that governed all food for all health effects, and that is clearly pref-
erable.
Mr. Whitfield. Thankyou very much.
Mr. Burr [presiding]. Tlie gentleman's time has expired.
Dr. Cobum.
Mr. COBURN. Thank you.
I want to get back to this concern that was raised over FIFKA
preempting FDA. Address that for me, if you will, Ms. Duggan, and
let's talk about that and if in fact that is a legitimate concern in
this legislation and what can be done to change that.
Mb. Duggan. The issue that they have raised is possibly legiti-
mate, but I think that we have the opportunity to work with the
committee to resolve that issue. It is dearly not what the industry
would want to see, and we did not read this language as requiring
it.
I think the interest of the industry in supporting a provision tc
coordinate FIFRA and Food, Drug, and Cosmetic Act tolerance de;
cisions more closely was to avoid situations where, if a chemical die
not have a tolerance, it £ilso did not have a registration so that i1
wouldn't be available in the marketplace and it wouldn't be usee
on farms and then that product would then not be adulterated. I
this provision does not in fact accomplish that and create more reg
ulatory problems than it solves then, we clearly have an intereai
in working with the committee to resolve that.
Mr. COBURN. And you think that can be done?
Ms. Duggan. Absolutely. No question.
Mr. CoBURN. All right. Eftrlier it was mentioned that there wai
no response initially to your petition and therefore there was i
forced response to the petition. Is that commonplace in — and '.
would like all three of you to answer this — in terms of your dealinj
with this Government? That has been my finding. Pm just wonder
ing if it is the same as yours. I haven't taken anybody to court U
get an answer to a letter yet, but I may.
iigilK^byCmigle
78
Ms. DUGGAN. It is an all too common feature of regulatory prac-
tice to petition the Government for policy answers and policy ques-
tions and not to receive an answer.
Another issue that is under the jurisdiction of this subcommittee
is the issue of FDA reform — ^matters over which there has been
quite a bit of debate. In the food additive petition process, it takes
an average of 7 years to get a decision on a food additive petition.
In some cases — ^trom the FDA — we have petitions that have been
pending for several decades. So that is a hallmark, I guess, of deal-
ing wiui the agencies.
Very, very recently NFPA petitioned the FDA on some health
' claims matters, asking for changes in the health claims regula-
\ tions, and we received an answer within 2 weeks of the statutory
! deadline, which was 180 days, and I think that was a unique ezpe-
^ nence that we welcomed, and we praised the agency for being able
'^ b) meet that deadline, but it was certainly the exception and not
^ the rule.
Mr. COBURM. Dr. Goldmsin commented that there perhaps was
one section of this bill that was too onerous in terms of requiring
them to respond within 30 days. Would you care to comment on
tliat? Is that an inappropriate Eimount of time for a government
agency to respond to an inquiry?
Ms. DUGGAN. Was she referring to the FIFRA cancellation and
auBoension procedures?
Mr. COBURN. Yes.
Mb. DuGGAn. The administration's characterization of that provi-
don, which is not under the jurisdiction of this committee, is curi-
ous to me. Right now the current procedure takes about 4 to 5
years to canc^ registration under FIFRA. This piece of legislation
would set a 1-year definitive time line for that procedure to take
place, and the nearing would I believe be required within 20 days.
Whether you think that is an appropriate timeframe for stream-
lining or not, it is clear that that procedure will be much shorter
and much cleaner than the current procedure which is a trial type
Clearing. So I think it is a question of degree about how short it
should be and what the rights of the registrant should be find what
Uu opportunities for scientific peer review ought to be. Clearly the
indostzy has a certain viewpoint that due process and peer review
Aould be strong features of a cancellation procedure.
Hr. COBURN. I agree.
Mr. Stolte. I think in many cases it is in farmers' best interest
to expedite the cancellation process as well because getting those
older, more toxic products on the market encourages the develop-
ment and the new market for newer, safer products, and we are in-
tmstedin that.
Mr. COBiniN. Okay.
Dr. Ziller.
Mr. ZllJ.BR. I agree, and I go back to my earlier point which is,
wbmever you have uncertain^ around these kinds of issues in the
ngnlatoty sphere you always have uncertainty in the minds of con-
nmera, which is not good.
Mr. COBURN. Fine. Thank you.
I dont have any additional questions, Mr. Chairman.
Mr. BlURAlOS. I thank you, Dr. Cobum.
Bl
DigilizcdbyGoOgle
74
Mr. Burr.
Mr. Burr. Thank you, Mr. Chairman.
Mr. Stolte, just a follow-up on part of your testimony where you
said that modem technolo^ haa greatly improved our ability to
make sure or detect the tiniest trace of chemicals in food, yet cur-
rent law, I think, doesn't allow us to use it. Could you expand on
that just a little bit?
Mr. Stolte. Well, we have had tremendous improvements, No.
1, in detection, in our ability to detect pesticide residues. As several
people have stated, we have gone from parts per thousand or
10,000 to parts per billion or quadrillion, which is common these
days. So we have the situation now where we are going to have
broad-scale cancellation of pesticide uses not because they are not
safe, but because they are detectable because of modem science,
and we are saying that is wron^. If there is a safety concern those
uses should not be allowed, but if they are canceled strictly because
they are detectable that is not good regulatory policy.
I think the other area where we have made tremendous strides,
and I don't have a medical background — but we have also made
tremendous strides in determining cancer risks, cancer causes, real
health concerns, as opposed to alleged health concerns since 1958,
and Delaney simply hasn't allowed us to progress in those areas
the way we need to.
Mr. Burr. Let me ask you, is it possible under current law that
pesticides could be approved but products r^ected because of the
use of those pesticides? I thought I understood something that one
of the three of you said earlier about that, that potential could exist
under current law. Is that in fact true?
Ms. DuGGAN. If you have a situation where you have a pesticide
that is registered but it has no tolerance and it is available in the
marketplace, it is feasible that someone could use that chemical.
Then the residue on the food that was produced from it would of
course be illegal because there would be no tolerance for it. We
don't expect that that happens very often, but we would like to
make sure that those two things Eire coordinated, that if there is
no tolerance, there is £ilso no registration. But right now the illegal
application or a misapplication of a pesticide could result in a resi-
due that was either over tolerance or was somehow illegfil, or the
use of a product that is used on something for which it has no tol-
erance or for which it is not approved, ana that would be an illegal
application and would be adulterated under the meaning of uie
Food, Drug, and Cosmetic Act and could be seized. The person who
made the application would be criminally prosecuted, which does
happens.
Mr. Burr. And may not know that they have broken the law. Is
that conceivable?
Ms. DUGGAN. It is possible.
Mr. Stolte. Yes, it is.
A related problem that is with the use of so-called minor use pes-
ticides. For mstance, we have pesticide products that are registered
for use on one type of lettuce, and there are about five afferent
kinds of leafv lettuce. It is because of the registration costs for that
product, ana you are talking hundreds of thousands of dollars in
some cases to register it for that particular use. It is registered for
;ci^5^1gle
76
use on one spedes of lettuce but not another. Technically, use of
that product on a nonregistered typ« of lettuce U a violation of the
label and puniahable. l^at is anouier related problem we have to
Delaney.
Ms. DuGGAN. I should add that that does not necessarily mean
that there is a public health risk associated with that. It is simply
that there is no registration.
Mr. Stolte. That is right. It means the economic costs are not
justified.
Mr. Burr. Dr. Ziller, just a comment from you about the EPA's
flexibility under H.R. 1627, because I think that we had quite a few
' comments early on about the lack of flexibility, and, you know, my
' interpretation of this was that the decisions were sort of laid in
" their lap. Is that in fact what you read into H.R, 1627?
^ Mr. ZILLER. Right, I agree with you. My reading is that the bill
gives a tremendous amount of scientific flexibility to EPA to de-
velop the appropriate kinds of additional regulations that are in-
J volved in implementing the law, and that is the intent, I think. I
. think the hang-up is more the legal one — what do we do if we get
g sued? If you have gone through appropriate rulemaking procedure
g you should have something that will withstand a charge,
n Mr. Burr. I found it a little odd — and you might want to com-
ment on this — that Dr. Goldman did not want to see, I think, in
[ response to Mr. Whitfield about why they negotiated the court set-
tlement, that they didn't want to see the courts come in and regu-
late what they did yet she was sitting in front of Congress, if I m-
Cerpreted her correctly, asking us to do the same. Was that your
interpretation of it?
Mr. Ziller. Yes.
Mr. Burr. My time has expired, Mr. Chairman. I yield back.
Mr. Bujrakis. I thank the gentleman.
I think I'm just going to concentrate on one question. EPA has
stated that it is just as significant to be concerned about others in
addition to infants and children. Mr. Waxman certainly has argued
very, very stronely that H.R. 1627 does not provide sufficient meas-
ures to assure that pesticide tolerances safeguard infants and chil-
dren, and that is important.
I don't know, Ms. Duggan, we all have children, we all have
grandchildren, so we are concerned about this, and that is really
why I tried to get to the point with the previous panel to see if they
haa any axes to grind because they made statements that they felt
that H.R. 1627 is not in conflict with those safeguards. So I would
like to hear your responses. Take as much time as you would like.
Ms. Duggan.
Ms. Duggan. The children's safety provisions are a new feature
of the bill since the time it was introduced in the last Congress,
and it is directly responsive to the National Academy of Sciences
report on the diets of infants and children, and it seems to be de-
signed to require the administration, the administrator of EPA,
FDA, and USDA, to implement the recommendations of the report.
Specifically, it requires diem to collect appropriate data on con-
sumption patterns of infants and children. It requires them to im-
prove their surveillance of pesticide residues and collect informa-
tion on what residues are in the marketplace so we will know what
DigilizcdbyGoOgle
76
the e:^>osure is and to have better information about what the sen-
sitivities are of infants and other subpopulations and what the tox-
icity efTects are. Taken together, that information should dramati-
cally improve risk assessments and should produce tolerances that
are fully protective of children.
That is certainly what we recommend, and it is in fact what the
NAS recommended we do. So I feel that this is a very good provi-
sion that is new to the bill this year and should be adopted by the
Congress.
Mr. BiLIRAKIS. Thank you.
Mr. Stolte.
Mr. Stolte. Well, I can't embellish that too much.
I think the new provisions in the bill, along with the existing au- i
thority that the agency has brought up in previous testimony to
protect infants and children and special populations — ^I think we
nave made an extra effort to safeguard ttie health of those sub-
populations, and we feel the bill is very adequate.
Mr. BnjRAKis. Dr. Ziller.
Mr. Ziller. I just want to add one slightly different slant on this.
You know, when we sit up here we real^ represent a lot of member
companies that are veiy responsible food processing manufacturers
throughout the United States, some of whom are worldwide compa-
nies, and they have a lot to lose if their products are not safe.
When eiirlier drafts of this legislation were floated around for com-
ments I can remember getting calls from some of our member com-
pany people who specifically asked about this point. They want this
year, as Juanita said, to include this kind of language specifically
to ensure that children are protected Etnd that EPA is basically
mandated to use the NAS recommendations and make sure these
things are safe for those as well as other important subpopulation
groups.
Ms. DuGGAN. A follow-on point that was discussed earlier is that,
in addition, the bill does give EPA full flexibility and authority to
take into account any data that they feel is important to protect
a subpopulation, specifically infants and children. They are not pre-
vented in any way, shape, or form from taking into account neC
essaiT information to make sure that tolerances protect the public
health, and certainly we wouldn't want them to disregard that irx'
formation.
So right now they take into account information on about 22 sul?'
populations, and certainly they could probably do that much bette'
if they had the kind of data that w£is recommended by ^e NA3-
But the notion that somehow this is preventing them from doin^
something they need to do to protect the public nealth for children
I dont think is supported by the language in the bill.
Mr. BiLIRAKIS. I was very surprised really at their attitude on
this. The flexibility seems to be there, certainly the responsibility
it seems to me is there, and they dont seem to want to pick up
that responsibility unless the Congress actually mandates every-
thing.
In vour opinions — and we have another panel, and we will go
into this with them — why are we getting this type of argument that
H.R. 1627 does not provide adequate safeguards? Do you have any
blinking in thia regard?
77
Mr. Stolte. For children specifically?
Mr. Bujraios. Yes.
Mr. Stolte. I don't know.
Ms. DuGGAN. I will make one comment, that I think the adminis-
tration's comments have been fairly constructive in this Congress
and have raised issues that I think are resolvable, and I commend
them for narrowing their list of issues that they consider to be
problematic from previous Congresses. I think that we could
produce a piece of legislation very easily in this Congress and re-
solve some of the issues they have raised.
Mr. BnjKAKls. I would hope so. I got that also from the testi-
mony earlier, that they were willing to sit down and work some of
Uiese tilings out.
Okay. I thank you so very much and appreciate so much your
taking the time to be here before us.
The next and last panel will consist of Mr. Erik Olson with the
Natural Resources Defense Council; Mr. Jay Feldman, National Co-
alition Against the Misuse of Pesticides; Ms. Carolyn Bricke;^, exec-
utive director of the National Campaign for Pesticide Policy Re-
form; and Mr. Jay Vroom, president of the American Crop Protec-
tion Association.
As I always try to do, I want to thank this panel for their pa-
tience, for their willi^ness to sit through all of the other panels
and await their turn. That is very good of you.
We will start out with Mr. Olson. Again, your full testimony,
your written testimony, is made a part of the record, and I would
appreciate very much if you would try to limit yourselves to as
086 to 6 minutes as possible.
Mr. Olson, please proceed.
STATEMENTS OF ERIK OLSON, ON BEHALF OF NATURAL RE-
SOimCES DEFENSE COUNCIL; JAY FELDMAN. EXECUTIVE DI-
RECTOR, NATIONAL COALITION AGAINST THE MISUSE OF
PESTICIDE^ CAROLYN BRICKEY, EXECUTIVE DIRECTOR.
NATIONAL CAMPAIGN FOR PESTICIDE POUCY REFORM;
AND JAY J. VROOM. PRESIDENT. AMERICAN CROP PROTEC-
TION ASSOCIATION
Mr. Oi50N. Thank you.
My name is Erik Olson. I'm a senior attorney with the Natural
Resources Defense Council. We have worked on pesticide issues for
over 20 years and were involved in the 1986 effort jointly with
some in Uie industry to tiy to get FIFRA reform through and pes-
ticide reform through. It fell apart, and then in 1988 we partici-
pated in the effort to get a narrowed-down bill through, and that
was successiiil.
What I would like to talk about today rather than going through
the written testimony in detail, since that is going to be entei^d
into the record, are about some highlights. It is our hasic viewpoint
that current law is not adequately protecting public health and the
environment and that we should not be talking about relaxing pro-
tections but about making sure that we have adequate protections
for public health and for the environment.
I would like to get right down to the Bliley bill and some of the
concema that we nave about the bill and, in particular, the Na-
DigilizcdbyGoOgle
78
tional Academy of Sciences recommendations. There are four major
recommendations that I think are worth discussing that we believe,
if H.R. 1627 were enacted, that EPA would have great difficulty if
not be blocked from implementing these recommendations, and 1
will explain why.
First, the NAS recommended that multiple residues — ^what they
said was, "All exposures to pesticides, dietary and nondietaiy, need
to be considered when evstluating the potential risks to infants and
children." Second, they said that the estimates of total dietary ex-
posure should be refined to consider intake of multiple pesticides
with a common toxic effect — in other words, additive effects of mul-
tiple pesticides. In other words, you are supposed to look at the to-
tality of exposure from all sources and from all the pesticides with
a common toxic effect according to the Academy.
Our concern on that point is, first of £ill, that the bill as written
appears to require a review of each individual residue, and, that
is, the decision is made exclusively upon residue-by-residue deter-
minations. That is on pages 57 and S9 of the bill. In other words,
at least as we view it, EPA would have difficulty basing its regu-
latory decisions upon what the Academy recommended, which is
looking at the totiility of exposure firom drinking water and from
other sources as well as the food stuff. We believe that that Acad-
emy recommendation with changes in the bill could be imple-
mented under the bill.
Second, we are also concerned about the FIFRA and Codex har-
monization provisions which we believe would, at least arguably,
override the health-based standard that is at least in theory in the
bill. For example, the FIFRA risk/benefit analysis requirements
and some of Uie Codex harmonization requirements could simply
override the basic considerations of children that are mandated in
other provisions of the bill.
TTiird, the National Academy committee, on page 9 rea>mmended
that, "Aa uncertainty factor of up to tenfold traditionally — similar
to Uiat traditionally used for fetal development toxicity should be
considered when there is evidence of postnatal developmental tox-
icity or when the toxicity testing relative to children is not com-
plete." In other words, there is a recommendation that there be an
additional uncertainty factor where there ere incomplete data. Our
concern is, again, that that recommendation is not likely to be im-
plemented under the bill.
Fourth, the Academy recommended that EPA should modify its
decisionmaking process for setting tolerances so that it is based on
health considerations rather than agricultural practices. Children
should be able to eat a healthful diet — ^this is the Academy — con-
taining legal residues without encroaching on safe^ mai^ns. This
goal snouTd be kept clear. That is, we view that the most fun-
damentfil recommendation of Academy.
Our concern is that the benefits override provision which allows
very broad considerations such as the ability of the pesticide to en-
able domestic growers to maintain the availability of adequate
wholesome and economical food supplies and other benefits would
simply render nugatory the consideration of children's smd other
health effects and that that broad override provision along with the
broad FIFRA and Codex harmonization provisions woiUd simply
d by Gabble
79
render the health-based standardB that are found elsewhere in the
bill essentially without effect.
Finally, there is a recommendation of the Academy that age-re-
lated differences in exposure should be eliminated uamg 1-year age
Sroupings. That is something that we believe should be required of
the agency, and so far the agency hasnt implemented that.
I see my time has expired, and I had other things to say, but 111
leave those for questions.
Mr. BlURAKIS. In the process probably you mil be able to make
those points.
Thank you, Mr. Olson.
Mr. OtSON. Thank you.
niie prepared statement of Erik Olson follows:]
I. INTItODUCnON
I am Erik Olson, Senior Attorney with the Natural Resource* Defense Council
'^'HiX}}, a national nonprofit environmental oreaniution dedicated to protecting the
PUtdic health and the environment with over 170.000 members. For more than two
<^c«dee NRDC has been actively involved in the boat of iaaues presented by the in-
'''easing use of pestiddee and their impact on the environment 1 appreciate this op-
I'ox'tunity to testify today regarding possible amendments to the federal Food, Drug
U^d CcMmetic Act and ower pesticide laws. To briefly summarize:
Current law is not ad«
the adverse efiects o
mental safeguards.
Oinventional pesticide use in the United States has increased dramatically over-
the past three decades. EPA estimates that one out of every 10 public drinking
water wells in the U.S. contains at least one pesticide- muui of the Mississippi
baMn's water contains pesticides at levels above EPA health standards during
the spring runoff; a large percentage of the food supply contains significant pes-
ticide residues; and the lugs are winning" due to increasing resistance to pes-
' The proiMsed Bliley bill (H.R. 1627) would undercut public health protection by:
(1) failing to asaiu^ that children and infants are nillv protected, through the
complete implementation of the recommendations of the National Academy of
Sciences: (2) failing to consider the broad array of pestidde risks from multiple
pesticide residues and multiple sources of exposure; (3) locking into statute the
override of health constderabons by aBricultural "benefits" ana eliminating c
lerally pn "' '
■ nFti
rent curbs on carcinogens; (4) genera
citizens from dangerous residues; (5, ._, .„ „ ,
FFDCA, and Codex, to the detriment of specific and enforceable public health
protections in the FFDCA; (6) failing to help farmers off the pesticide treadmill.
Itimately, the roost eSective method for protecting public health and the envi-
ronment is to reduce the use of pesticides at their source. Numerous reports
document the potential and importance of reducing overall use of pestiddes.
* Numerous pestiddes have been found to mimic the female hormone estr(»en or
to disrupt the endocrine system, wrecking havoc on these animals' reproductive
ability.
HISTORICAL OVERVIEW
In quieter times, and following the leadership of the Eisenhower administration,
a bipartisan Congress declared war^ on cancer, enacting laws like the National
Cancer Attack Act and the Delanev Clause to the federal Food, Drug and Cosmetic
Act. These and other laws reflected, a national commitment to rid our sodety of this
most pemidouB disease — a disease that results in so much economic loss and untold
human suffering. Since then, billions of public dollars have been expended seeking,
usually unsuccessfiilly, a cure for cancer.
There have been some successes, partici
have been diagnosed with cancer. NevertJ . ._
bacco-related cancer has risen by more than 20 percent, with sharp increases in
DigilizcdbyGoOgle
80
childhood brain cuicar, pro«t«to and t«BticuIar cai
•lone will now ftrUce 1 in S American women during their li _ . _ .
million people in the United States (over one quarter of the population) will develop
Bome form of cancer, from which 20 percent of the population mil die.
The issue before this committee, and thia CongrSM, con be simply stated: la it
now time to reduce this commitment to cancer prevention by rolling back protec-
tions provided to the American people against csncer-causing substances permitted
in the food chain? The answer to us is a categorical NO and we strongly oppose HS.
1627 on that basis. We believe to weaken already flawed federal pesticide laws
would represent a breach of faith with the American public and that, instead, theM
laws need to bs reformed and strengthened. The goal should be to achieve a reduced
reliance by American agriculture on these most toxic of chemicals not to enact a
statute written for the r^^ulated industries.
A litany of studies have concluded our pesticide laws have been an abysmal &il-
ute in need of a complete overhaul. The Enoirvnmental Protection Agency and the
Regulation of Peaticidea, Senate Committee on the Judiciary, Subcommittee on Ad-
ministrative Practice and Procedure, S4th Cong., 2d. Sess (1976); Cancer-Cauting
Chemicala in Food, House Committee on Interstate and Foreign Commerce, Sub-
committee on Oversight and Investisations, 95th Cong., 2d. Seas. (1978); GAO,
Delays and Unresolved Itauea Plague Neu Peatidde Programs (1980); EPA Peatiddt
Regulatory Program Study, House Committee on A^culture, Subcommittee on De-
partment Operations, Research and Foreign Agriculture, 97th Cong., 2d Sets.
(1982); GAO, Monitoring and Enforcing Food Safety—an Overvieu) of Past Studiet
(1983); PrabUma Plague the Enoironmental Protection Agency's Pesticide Regulatory
Aetioities, Committee on Government Operations, 98th (Jong., 2d Sess. (1984); GkO,
Peaticidea: EPA'a Formidable Task to Aasesa and RegulaU Their Risks (1986); GAO,
Pesticides: Better Sampling and Enforcement Needed of Imported Food (1986): snd
GAO, Pesticides: Need to Enhance FDA's Ability to Protect the Public From Illegal
Residues (1986).
The failure of our pesticide laws hss been due to the process itself as well as the
acknowledged weaknessee of risk assessment, which is a half arfhalf science that,
ironically, both representatives of industiy and the environmental community seem
to agree, is frau^t with unreliability. There are inherent vagaries and uncertoii^et
in quandtstive risk assessment because, among other things, of the necessity of re-
lying on data from animal studies and the generic inaccuracy of the process itself.
As a result, a few years ago, FDA Deputy Director Robert Scbeuplein warned,
government agencies risk losing the integrity of the science and ot^ectivit; they
need frxmi it by continuing to sugnst risk assessments are better than they
are . . . We have not seen a sdentificbreskthrougli which now permits the precise
[estimation] of low-level canco' risks." 53 Fed. Reg. 41104, October 19, 1988.
Moreover, not only do risk assessments generally ignore the special risks toxic
chemicals pose to infants and young children, by taking a chemical-t>y-chemical, use-
by-use approach, they also fail to address the cumulative aspects of exposure to
toxic substances. (National Research Ouncil, Peaticidea in the Diets of Infants and
Young Children, 1993.) For example, there are more than 300 pesticidal active in-
rients ss well as an imperfectly examined large number of inert ingredients. For
most part, existing EPA pesticide food tolerances do not even attempt to cal-
culate the aggregate human health risk presented, nor do they address tne cumu-
lative and synergistic effects on multiple pathways of exposure.
n. CONTINUmG THE WAH ON CANCER
The only bright spot in this flawed regulatory regime is the Delaney Clause of
the Food, Dru^ and Cosmetic Act, Enacted in 1958, the famous "clause" prohibits
aiw food additive in processed food that "induces cancer in man or animal."
Since its ensctment, the provisions of the Delaney Clause prohibiting carcinogens
in processed foods have largely been ignored with respect to peBticidss. EPA's con-
sistent approach throughout tlie 1980a 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 due to concentration during processing or post-
harvest application, are subject to Delaney. The Agency's purported "de minimis"
eticy, allowinE carcinogens based on the purported tevel of cancer risk, was r^ected
cause "the language of the Delaney Clause, its histoi? and purpose, all reflect
that Congress intenoed the EPA to prohibit all additives that are carcinogens, re-
gardless 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 ccmunodities will or will not be processed, the presence of
Digilizcd by LjOTIQ IC
ides in raw commoditiM that are subject to processing is fbre-
As the result of a consent Judgment entered in the companiim case to L«i, entitled
AopI* ofUu Statt t^Califontia v. Browner, the Agency is now committed to imple-
mepUng Um Delan^ Clause (or specific pesticides, pursuant to a specific timetable,
*HiHtM«fig thdr presence in procisssed foods and, where necessarjr, in the relevant
nw eoramodities as well (e.g., in oran^ and orange juice). Under this settlement
agreement, anx the next decMe, certain pesticides that are found hy EPA to induce
caneor in man or animal and that are present in processed foods (either through
'concentration" when raw commodities are processed or from poat^harvest applica-
tion) wiU be phased out of use. A copy of that consent judgment and list of tne ini-
tial pestiddea to which it will apply is appended to this testimony.
m. THE PROWaE OF THE DELANEY CLAUSE REMAINS UNFULFILLED
United ttcbent of our ^mowiedge. (See "No More Pesticides for T>uia»Tf New York
TimM, Match 9, 1993) Acctnilingly, the clause is grounded in a policy of prevention:
prohibiting the addition of eardDogens in the food supply to prevent avoidable can-
cers in humans, This approach was deemed necessary by (Tongreas. since the entire
nation's population wmud otherwise be routinely exposed to cardnogenB in thedr
daily diet That pramiaa remains as valid todar as it was in 1968.
AeeordlnilT, Uie philosopl^ behind the Delan^ Clause preventing unnecessary
oqwaure to nasardoua sutwtances — should be preserved — either by implementation
f£ the existing law or in any new legislation. Prevention is worth a pound of cure.
We ttiU do not know whether humans are more or less sensitive than laboratory
Mitmnlj to most carcinogens and whether one carcinogen may increase the cancer-
cauainfc effects of another. We atiU do not know the cumulative impact of dotens
lisk-by-risk approach, grounded in myopia, "Managing" cancer, rather than prevent-
iwit
nie reali^ of life is that we are exposed to a multiplicity of toxic substances. Cal-
oilatiDg the combined riaks of these exposures is problematic at best; some 300 pes-
lidde Klive ingredients are used on food as well as an imperfectly examined large
number of "inert' ingredients. For the most part, existing EPA pesticide tolerances
br allowable pestidoe residue levels do not even attempt to calculate the aggregate
btman health risks presented, nor do they address the cumulative and synergistic
aflMa on multiple pathways of exposure.
lostsad of maiiitjiiiing the status quo on pestidde use, we should follow Rachel
Csrson'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 polidng the result is too reminiscent
of Lewis Carroll^ Vhite knieht', who thought of a plan to dye one's whisk-
ers green and always use so Targe a fan that they could not be seen.
IV. EXISTTNO PESTICIDE LAWS HAVE FAILED
Ovw the past thirty years:
■ C^oimntional pestidde use in the United States has increased dramatically, from
611 million to more than one billion pounds. Total pesticide use, including wood
prNervatLvea, disinfectants and aulfm* now exceeds two billion pounds annually,
KAt pounds for eveiy man, woman and child in the United States.
* EPA estimates that one out of every 10 public drinking water wells in the U.S.
contains at least one pestidde; their data indicate that nearly 10,000 commu-
dty drinking water wells and over 440,000 domestic water wells contain pes-
ticides. Sevens-four different pestiddes have been found in groundwater which
Allies drinking water for 32 states. Agriculture is also now the number one
■OUKC of pollution of surface water; pestiddes have found their way into count-
liss lakes, rivers and waterways thrmighout the nation.
* According to the FDA, at least 3S percent of the food supply contains pestidde
naidues. This understates the actual amount because routine lab testa detect
fewer t^an half of the pestiddes applied to food. Many foods sampled by FDA
had more than one pestidde residue; some had as many as twelve.
■ llie bugs are winning. At the time the Delaney Clause was enacted, 137 spedes
of insects and mites had become resistant to chemical pestiddes. Today, the
DigilizcdbyGoOgle
number of nautant peaU ia abnoat 600 (aa wall as 100 apedea of plant patho-
geiu and 48 apedeB in weeds).
In 1972, Congreaa required that the chemical induatty test their products and the
government reassess tacdr safety. For fifteen years, tms requirement went largeli
Ignored. Finally, in 1968, Congress established explicit timetables by which sucn
testing must be completed, to be concluded by 1997, and for pesticides to b«
"rereeietered' based on the results. Yet, to date, only 27 of 600 active ingredients
have Dcen reresiBtered (and EPA may miss this deadline by a -'---"- '
Nonetheless, in iBboreto^ tests, 7J
ronment have now been found to a
Mounting evidence suggests a strong correlation between pesticide en>osure and
the development of cancer in humans. A National Cancer Institute (NCI) study
found that formers exposed to herbiddea had a six times greater risk than non
faimers of contracting one type of cancer. Another study Found a link between
breast cancer in women and cdevated levels of DDE, a metabolite of the pestidde
DDT, in their fat tissue. Research also indicates tnat children in homes where
household and garden pestiddea ere used are seven times as likely to develop child-
hood leukemia. There are still unexplained clusters of cancer among farmworker
children at placea such aa McFarland and Earlimart, California.
llioee of us bom after Worid War II— the "boomers'-^ave 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 '^aby boomers" bom be-
tween 1948 and 19S7 are far more likely to contract cancer than members of their
grandparenta! generation. These sdeatists found persistent increases in cancer that
could not be accounted for by smoking, aging, or better diagnostic testa. The typeg
of tumors found to be increasing in the general population were also strikingly simi-
lar to those found in earlier studies of faimers who were exposed to a variety of
cardnogens, such as fertilizers, pestiddes and other solvents.
Authored by epidemiolorast Devra Lee Davis, the study, published recently in the
Journal of the AJnerican Medical Aasociation, found that cancers unrelated to smok-
ing — that affect parts of the body other than the lungs, throat and mouth — were oc-
curring in white male "boomers" at triple the rate of their grandfathers. White
women in the same age group had 30 percent more non-smoking 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 businesa av
uaual. American agriculture must move in a new direction — a direction that amply
relies far less on toxic chemicals to produce our food. The first step in that journey
must be the alow, but eventual, pnase-out of "worst actor" pestiddes, chemical*
whose hazarda have been well-known for up to 50 years. See white Paper: The Need
for a Phaae-out of Carcinogenic Pesticidea, Natural Resources Defense Council (copy
atUched),
Thus, while man;r approaches to do s<
live reform l^slauon must be the aceo
• Comprehensively deal with chronic health hazards from pestiddes;
• Respond to the special risks peatiddee pose to children as most recently recog-
mied in the National Academy of Sciencea report on that sutqect; and
• Substantially reduce overall pestidde use in American agriculture,
V, PESTICIDE REDUCTION: THE POLLUTION PREVENTION SOLUTION
Current reeulatoty programs have been unable to reduce the hazards caused by
pesticides. Ultimately, the most effective method for protecting public health ana
the environment is to reduce tiie use of pestiddes at their source. Numerous reports
document the potential and importance of redudng overall use of pestiddes.^ Ac-
cording the National Academy of Sdence's SoU and Water Quality: An Agenda for
Agriciilture NAS report.
Source control to reduce the total mass of pestiddes applied to cropping sys-
tems should be the fundamental approach to reducing pestidde losses from
farming systems,^
Several European countries induding Sweden, Denmark and the Netherlands
have adopted national programs that incorporate the fimdamentol approach of pes-
ticide use reduction. Concern about environmental pollution has prompted these
' NatiDnal Rraeuch Council, SoU and Water Quality: An Agenda for Agricultun, Washington,
D,C., 1993. OfRce of Technology AMewment, Beneath the Bottom Line: Agricultural Approaehet
lo Reduce Agrichtmical Contamination of Groundwater, Washington, D.C, 1991.
'Sal and Water Quality, p. 82.
dbyGoO^'
e on, pevticidc-
aecraaring crop yield*.
Altiiaum ncA perfect, these pro-ams are models for what is possible in the U.S.
"nM Swecudi program achievea a 60 percent reduction in the weight of active ingre-
di«nt applied between 1986 and IdSl and an additional GO percent cut is currently
being inulemented. The Danish program achieved a 26 percent reduction between
U86andl990.*
Numerous methods are available to reduce agriculture's use of and reliance on
peaticidee. The National Academy of Sciences in their report, Alternative Agriculture
JlfhnimwtfH the potential for reducing pesticide use throu^ the adoption of inte-
grated pettt manaijement and other practices and systems for agricultural sustain-
abilitj;. Such practices can lower coats for fanners and pest managers and in many
cues increase the qualit^productivity and yields.*
According to a 1991 NRlX: report. Harvest of Hope: The Potential fi>r Alternative
Agriadture to Beduce Pettiade I/se, techniques are available to reduce the use of
peetiddes between 26 and 80 percent on nine different cropping systems throughout
""■"""'* " '*" '■ ' ' " d jjest management and
t implemented without
. T • ..r ■ . . , ve Summary attached).
Federal programs nave failed to encourage and, in many cases, have impeded the
:ting crop yields or production costs (Executive Summary attached).
il programs nave failed to encourage and, in many cases, have impeded the
adoption of pest management methods that reduce the use of pestiddes. Farmers
are interested in implementing new approaches but poorly funded and uncoordi-
nat«d Cederal proerama have been of little assistance.
Hie puhhc is looking to Coneresa for action. A comprehensive federal pro-am
Uiat encourages the trend towards reduced use of pestiddes is long overdue. Legisla-
tion is needed to mandate a program that indudes, at a minimum, the following
the U.S." Depending on the crop, methods such as integrated i)i
biolaDcal, cultural, mechanical and physical controls can be ii
■jmificantly effecting crop yields or production costs (Executive
(1) Mettsurable and enforceable pestidde reduction goals.
(2) Regional, eco^ratem-based and crop-spedfic pestidde reduction programs that
broadly involve farmers end other experta in integrated peat management and sus-
tainable agricultural systems,
(3) Substantial resources directed towards technology transfer for pesticide redue-
tiMi, induding model demonstration farms and coet-^are assistance,
<4) Priorituiation of existing pest management research and extension aetivitiea
towards development of integrated pest management and sustainable agricultural
r all federal agen-
(6) Creation of market incentives for farmers induding through government pro-
curement of certified-organically ^rown food.
(T) Development of nationwide initiative to reduce the use of nonagricultural pes-
tiddes.
VI. ENVntONHENTAL BSTROOENS: A WAKE UP CALL
For the reason why pestidde reform is critical, one need look no further than the
Gws t Lakes, the source of 20 percent of the earth's fresh water. Due to pollution
ncm DDT (banned in the '70b but still "out there") and other "environmental
~^ ' *B wildlife are literally being "feminized" bom hermaphroditic with
•w uv suuviuiK uueruuty, etobb oirui oeiecie, ana oenavior aonurmauaes. r^ise-
mtre, in the Flmida Ever^aoes, aUigator eggs are failing to hatch, Male alligators
vtlMuig bom with extremely amall pnalluses, one quarter the nonnal size, and tes-
toKeraoe levds ao low they >re probably sterile. Florida panthers exposed to estro-
1^ peatiddea have likewise experienced such reproductive fiulurei females are in-
WIs, males sterile with low sperm counts. The "vhf is no mystery.
Namennis peaticideo and other compounds, like dioxin, lead, chlorine and mer-
nij, have bften (bund to mimic the female hormone estrogen, wrecking havoc on
WW ■nimala, reproductive ability. Structurally similar to i«al estrogen, these com-
PWnds fit Into estrogen "receptors" in the body, adversdy afEecting the endocrine
'Virid midlife Federation, Peitieidt Stduetioa Programme* in Dtnmarit, The NeOurlandt,
wfSMdfn, November 1992, pp. 2».34.
t to Reduce
DiBiiizcdbjGoogle
84
mt«m, dlaruptlns nraiiM] MKual developmMit The iDO«t terioua reprodnctive
threat of theM tone mibttancM la not to adults but to the developing fetua, by cross-
ing the placenta during prenatal development. Levda of enTironmental eqwran
causing nich effscta are auipriaindy low, equivalent to tboee alao found in our own
food and water. In other worda, what we are doing to the wildlife, we may be doing
toouradves.
Conaider the fbllowing:
• A Daniah atudy of 21 induatrialized countries documented a 60 percent drop is
sperm count world-wide between 1938 and 1991. At the aame time, the number
(tt teaticular cancers has tripled.
■ In Taiwan, 118 b^ bmn to mothers noosed to PCB'a in their diet aufforod repro-
ductive defecta including abnormally small penises — the same effect previouBl;
(bund in both wildlife and labmator; animals.
• Breast cancer will now strike 1 in 9 women. A Mount Sinai School of liiedidiw
studv showed that women with hitter levels of the environmental estrmn
DDE (a breakdown product of DDT) in their breast tissue were more likely thin
other* to get breast cancer. Other studies are to the contrary.
Virtually all of ua have measurable quantitiea of DDE, PCBs and other envinm-
mental estrogens in our bodies. *I^s varpossible and ifs frig^taiing Qiat we mi^
be drowning tn a see of estrwen*" said ^anfbrd endocrindc^iat David Faldman. Is
the evidence concluaive? No. But multiple erooeure to literally hundreds of different
chemicals that can turn male animals into femalea, reduce sperm count, and cauK
infertility must be taken seriously. By what ri^t do we risk me reproductive abili^
of fiiture nnerations?
In late July of 1991, a multi-disdplinary group of some of the nation's leading ad-
entists met in Wingspread, Wisconnn to discuss "Chemically Induced Alteratiooa in
Sexual Development The Wildlife/Human Connection." They concluded they were
"certain of the following: a large number of man-made chemicala . . . have the poten-
tial to diarupt the endocrine ^atem of animals, including humane. These impacts
include ... decreased fertility, decreased hatdiing success, gross birth defomuties,
feminiiation, and compromised immune systems. The effecte are moat <rften mani-
fested In offspring, not In the ennsed parent. tHlumans may be at risk to the asme
environmental hazarda as wildlife."
Vn. FROBLEHS WITH THE BLU^Y BILL, H.R. 1027
We have been aaked to teatify on our views on H.R 1627, the so-called "Food
Quali^ Protection Act of 1995. While we are aware that some membera of ttiia
^ibcommittee aupport the bill, we regrettabfy muat vigoroualy oppose it, because it
is our belief that ft would encourage even greater pesticide use ind undercut even
the weak current protactiona of the food aupply from peaticide contamination.
The Bliley bill also would fail to assure that certam of the problems posed for in-
fants and children by pesticidee in foods, which were recognized by uie National
Academy of Sciences (NAS) in the important recent study entitled Festicidea in the
Diets of Infants and Children (1993). We are strong supporters of good science, and
believe that many of the proposals and issues raised oy the Academy are inad-
equately addressed, or actually directly contradict certain proviaiona m the Bliley
The Bliley bill'a proyiaions revising the Federal Food, Drug, and Cosmetic Act's
The bill fails to assure full implementation of the National Academy of Sciences'
(NAS) consensus report, Pestiades in the Diets of Infanta and Children (1993). This
report (bund that pesticide tolerances are not based primarily on health consider-
stions, and that generally the current regulatory system faUs to give special consid-
eration to the R>eiial vulnerabilities of inunta snd children to certain pestiddu.
The Committee recommended that the EPA change its decision making to be
baaed more on health connderatjons than on agricultural practices, and that several
spedfic changss must bo made to assure the protection of young children. Among
lizca by L-
Llo^le
8S
othor dungea that are needed, the panel said, ia the use of an additional 10 fold
&ictor to protect in£uit« and children iriien data from buddty testing for children
■re incomplete, as they often are, Moreover, the panel recommended Ihat EPA
should bass tc^erances on consideration of exposure to multiple sourcea and multiple
pestiddea with the same v similar tosic effect.
Am the AeademT stated, "Children should be aUe to eat a healthful diet containing
U^al re^uea without encroaching on safety marginB.'' These and the other NAS
recommendations should en>reasty be required to be followed in the legislation. Any
legislation that is passed snould require an explicit finding that exposure to leg^
limits is ssfe for infants and children,
(2) Failure to Consider the Broad Array ofPeatidde Riaks
The narrow inquiry required by the bill into the risks posed by a pesticide residue
not onW fails to account m vulnerable mnips like infants and diildren. In addition,
Um bill does not allow consideration of multiple rmidues and multiple pesticides,
and ^parently fails to consider the threats posed by so-cslled '^nert" ingredients
(audi •■ known cancer-cauaing chemicals like benzene).
"nius, under the bill's amiroBch, for example, a pesticide applied to scores of crops
could be used on each of thoee crops at a given risk level, posing total risks many
times hiiJier than the "negligible' risk level, yet this cumulative risk would not be
considered. This fbrces a hi^y unrealistie set of risk estimates that bear little re-
semblance to real world exposures, and would consistenUy understate real risks.
(3) Locking into Statute the Override of Health Conaiderationa By Agricultural Bene-
fit
H.R. 162? enshrines into law the notion that even if a pesticide residue poses a
significant risk to the public, the residue is allowed if it is said to have sufBdent
"bm^ts.' While the bill as drafted apparently allows each pesticide residue's riaha
to be calculated on a narrow baeia, its bertefita are to be calculated based on sn ex-
traordinarily broad set of principles, such as "enab1[ing) domestic growers to main-
tain the availability of an adequate, wholesome, and economical food supply . . . The
Bliley bill allows so much leeway that virtually any nsk could arguably be allowed
u ftcc^table because of asserted benefits.
(a Preempting Slates from Protecting their Citizeru
In these times when much is being said about the need to return authori^ to the
states, it is ironic that the bill would weaken current law by generally preempting
statea fhnn adopting tolerances more stringent than any new EPA tolerances for
pestiddes. States ahvays have bad the authority to adopt such tolerances, and only
in a fi)w well-justified cases have states used this authority. Like the bill's local pee-
tidde use control preemption provision, this state tolerance preemption provision is
unhutified and unnecessary.
PTot only have states only sparingly used their longstanding authority to adopt
these tolerances ezdusively in the most limited and necessary drcumstances, but
aiQ' ill-conceived stste tolerance that theoretically could be adopted could be chal-
lenged in state courts as ui^ustified or in federal courts aa an undue burden on
interstate commerce under the Commerce Clause, The only exception to the ban on
stricter state tolerances would be that EPA could allow a state to adopt such a toler-
ance if EPA finds there are "compelling local conditions' and certain other hurdles
are iumped. How are states to respond if EPA has failed to act with respect to a
bimy dangerouB pestidde residue such as the BDB problem in California, if this
bdl were enacted?
(5) HarmonuaOon and Coordination ofFIFRA, FFDCA, and Codex
We are deeply concerned that the faiU's provisions requiring that essentially the
FFDCA's health-oriented reqim«menta will be hormoniied with, and generally it ap-
Mars subservient to, the FlFRA. and Codex provisions is likely to undercut public
neslth protection and encourage litigation to weaken EPA tolerances for pestiddes,
(t) Failure to Help Farmers Off the Pesticide Treadmill
The Bliley bill, by essentially maintaining the status quo for pestidde use and
— ekening current law, fails to help fanners off the pestidde treadmill. It is impoi^
tint that mcentives be provided and that dangerous pesticides be phased out to cre-
ate the necessary dynamic to encourage the use of less toxic pestiddes and non-pes-
tfdde altemativea. lUs bill, unfintunately, does nothing to move the country In this
DigilizcdbyGoOgle
Introduction and Summary
There is now an opportunity for a m^jor shift in the way the nation's agricultural
avatem does busiaess-^ help fannos and consumera. Aa a nation, we must put
native peat management approaches that pose less risk. One central driving force
in this ahift should be the adoption of the principle that we should not be inten-
tionally adding cardnosens to our food supply. We should be phaaing out the use
J 5 J -1..Z — i_ .1. r -"-srnatives.
_ {diase-out/phaae-in are many. There are
_ .ibstantial uncertainties inherent in quantitative risk asaOMment due to data ^aps
""fc _
emphaaized, risk aasessments used to determine, for example, whether a ,
tidde auppoeedly poses a "one in a million riak," do not address cumidative risk
posed by that pesticide firom all sources of exposura (such aa air, drinking
water, food, etcO, yet such multiple sources of exposure should t>e considered!
■ The Acadeiny also hi^ili^ted that risk aseewmente fail to consider the risks
posed by the interaetiona of multifile earuxr-cauting or otherwise toxic pesticides
on the same food or in the complete diet. Since a single meal may contain ten
or more pesticide residues, this is a critical failure.
• Even if a pesticide were said to pose a "one in a million" risk in food, there gen-
erally are for greater risks posed by the pesticide to farmers, farm workers, and
the uiemical woricers who make the pesbdde.
• It is Important to consider that some subpopulations, indudin^ infonts, children,
and poor pomle (especially poor children) are likdy at especially high risk but
accurate {nwuction of these risks is severelv hamp^^ by serious gaps in expo-
sure, todci^, senaitivify, and interactive effecta data.
Ultimately, as in the case of CFCs, methyl bromide, and other ozone depleters,
there should be a phase out of food tolerances for carcinoEenic pesticides over the
next five to seven vears. Those carcinogenic food uae pestiddes whose tolerances can
most read^ be phased out should be revoked first, based upon a schedule estab-
lished by ESPA considering the availability of alternatives. Upon a finding by EPA
that ihan are safor alternative methods of pest management that would not lead
to a carcinogenic food reddue, EPA should be required to revoke the tolerance for
that carcinogenic pestidde reddue. No new tolerances for pesticides that are car-
dnosens should be issued.
Tolerances for pestiddes now categorized as A, B, and "^ssible" human cardno-
gens whose risks EPA has determined are quantifiable ("Cq") should be phased out
no later than 7 years &om the date of enactment. Any tolerance for a pestidde
which EPA has uready determined is a posdble human cardnogen but whose risks
are not quantifiable CSinquantifiable C) should be covered by tne phaseout on the
same date aa a Cq pesticide unleas the registrant demonstrated tc EPA's satisfac-
tion that its chemical is probably not a cardnogen. Food tolerances for existing pes-
tiddes determined to be A, B, or C cardnogena for the first time after the date of
enacbnent should be phased out within 7 years from such determination. These
phase outs would result in the revocation o£ the carcinogenic pestidde's toleraace
Bv operation of law without further EPA action at the end of the "sunset^' period.
Tne law should provide a dear process for one-stop EPA determinations of the cat-
egoTv of the pestidde. Pending the ultimate phaseout, progress must be made to-
waros implementing alternatives and eliminating the cardnogenic pestidde's tolcr-
In tandem with this phase-out of cardnogenic pestidde tolerances, EPA and
USDA should be required to adopt an aggressive national program of research, de-
velopment, and local demonstration to id«itify and assure the availability of alter-
natives to the peatiddes subject to the tderance phase out.
Why a Phase-out is Needed
Quantitative risk assessment remains part art, part sdence. There are numerous
areas of uncertainty involved in developing an estimate of the risk potentially posed
by a pestidde residue or bv any other environmental pollutant. Unc«1ainties derive
from a broad array of problemi, Induding gaps or uncertainties in toxicological data,
our failure to understand the difforences between the effects of a chemical on lab-
oratoty fnim^i^ versus humane, problems in determining what subpopulations such
■^^oqIc
ZC^/^>OglC
aa diildnn an at ^«d«l riik. ■*'*'"■'*<*■ In truwUtiag fkvm high doM to low doM
MpoMiTM, tb« l«d( cf hard daU on actual azpoaim to tha ehamical from multipla
■ourcea, and many other pnblama.
whan thne unoaitainnaa ariao, tha liak aaaeaaor leeka to make raaaonabla aa-
^Qptiona about tha mjidng data, and plugi tboaa valtwa, and aomatimat 'tafaty
Winn' intended to tiy to coraponaat* for poeaible undvoatimation of riaka, in
tMching the final riak iratimatiw However, the uncertaintiee in riak eatimatee can
°< lane (orders of magnitude) when the data gape are aignlficant. Moreover, for
'"But data gnpi — audi aa the lack of information on interactive eflecta of multiple
^*ttiiugenB nmaiuned in the real world — riak aaeeaement treditionallT cannot con-
■Utr tfaaae pmhlami Aa tlia National Academy of Sdancea haa made daar, in many
y^ atandard tUk anaaaoMnta may aerioualy underaatimate riaka, particularly for
Ja&nte and childran. AmMig Um moat important aourcea of uncertainty and poeaible
Underestimation of risks in dassic Ibod safety nak aaaeaamanta are:
-Aueroetioe EffteU: Compttx Uixturt* ofPuhdtUa and othtr Toxiiu
• XJnIike labOTatory rata, people generally go through their live* breathing, eating,
and drinking an axtraoroinarily oomplax mixture of toxic and potantiaily car-
dnooenic suostancea, both natural and anthropogenic. For example, pestidde
residue data Indicate that in a singje mesl, s penon can easily consume five,
tan, or more peeticide reaidues in hia or her food,
~ The cumulative tadoological efTects of pestidde active ingredients, "inert" ingredi-
ents, and other cardiugens from multiple sourcea should be considered, but are
oot.
* Good science would dictate thst the real world of exposure to complex mixtures
must be the baaia of our psstidde polides. Yet synergism, addltivitv, and other
poeaible joint effects of cardnogens in foods generally are not considered in risk
assessments. Sdentific literature indicates that in some cases, such ss with ss-
bestoB and smoking, radiation and smoking, or smoking and alcohol, syttergism
of cardnogenic effect have been shown; in other cases, additivity or other inter-
active eflecta are found.
Synersistic effects of peatiddes to animals as acute toxins (e.g. malathion and
EPS) have been shown in well -documented toiicological studies, but few if any
studies have sou^t to document whether pestiddes have additive, synergistic,
or antagonistic effects in causing cancer.' Pestidde users and registrants some-
times rely upon and use synergistic toxic effects of two or more pestiddes in
controlling pests by applying more than one pesticide at once (known as "pes-
tidde synergists'), to get more than an additive "kill."^ There is no a priori rea-
son to suspect that aynergistic toxic effect is necessarily limited to target orga-
Undereatimatee of Riaka to Children, Minorities, the Poor, and Other Subpopalationt
Due Conaideration of 'Aueraje' Conaumera and Gapa in Exposure Data
• Accurate data regarding the true levels of exposure of all important subpo^ula-
tioQS to individual pestiddes and on exposure to complex mixtures of pestiddes
and other csrdniMens, are virtually impossible to d>tain. Thus, traditional risk
assessment sets levels based on average" consumers— failing to protect the
moat exposed stUipopulations.
• Exposure to each pestidde from all media and sources, such as commerdally pur-
chased food, sport fish, drinking water, air drift, indoor and outdoor air pollu-
tion, occupational exposure and so forth, ideally should be considered, but gen-
erally are not. Often data on key subpopulations' actual exposure is virtiully
nonexistent so accurate risk assessment for those people is impossible,
• As the National Academy of Sdences pointed out, duldren tend to eat large
amounts of certain foods — in many cases an order of magnitude or more larger
amounts of some foods such as cetiain fruits and juices. Thus, pesticide residues
on those foods pose a disproportioDatety high risk to children.
• Some population subgroups, such as members of certain ethnic or religious mi-
norities who eat a disproportionately large amount of certain foods, also may
be at espedally high risk.
• The National Acad^y of Sciences report on children and pesticides pointed out
that children living in poverty may be at special risk due to higher exposure
^ See, tfD<Mll,J lOaaamn, CD., at Amdaz,}A.O.,Ciuantl and DouU'ToxkoI^^i: The Basic
Sdene* ofPoitom (MacmillaD, Second Edition^ 1980}; Murphy S.D., Cotta, L.G &%wab, B.W.,
"Pestidds Interaction* and DcTelopment of Tolerance," la EffKta of Chronic Expoeurta to Pea-
Iteidei on Animal Syttenu, J.E. Chunbers A J,D. Yarbroiuji, edi., pages 2ST-241. (Raven, 1983},
■Hayei, W.J. A E.R Laws, Jr., Handbook ofPetticide Toxicology, vol 3, 1508- 1610 (Academic
Press, 1991),
DigilizcdbyGoOgle
to toxiiw in more pollutAd nei^boriiooda, poor nutarition, and othemise com-
promiiMl hesltli.* niiu, Uw Academj notod, "the combinMl efEect of poorer
iMilth >Utus and of llkdr higiwr wcpotun to environmental toxicanta r"-~-~^
that Um Rirthw burden ('--^-'^ '- '^■" - "
tome effect* that do not p. _ _. __ __, ^..
expect that adverse eSects of peatiridea, whether acute or chronic, might be
magnified in this subpopulation. *
There may be "foodsheos , or oreaa of the country where people tend to eat fi-eeh
eommomtiea primaiil^ from local powers. Those who often eat local fieah fixtds
soon aft«r the crop la picked, ana who Uve in regions where croiw are man
heavily treated with certain peatiddea (due, for example, to local climatic or
peat infeatatiDn conditions), cmild be aqMsed to pesticiae residues that nmy be
substantially hi^er than the national average. For example, milk piroducts and
many freeh fruits and vegetables mav be distributad locally almost immediatel7~
after they are picked or produced, leaving Uttle time fbr residue degradatiim-
and potentially creating pockets of relatively heavily peetidde reeidue-ladem —
foods.
V Contider Highly Senmiiue Subpopula
• Risk asaesamenta generally are not specially designed to discuss or address the^
risks of pesticide exposure to espeaallv sensitive subpopulations due to Iheir*^
sensitivi^. As the National Academy of Sciences has recently emphasized, andX
as the scientific literature has documented, there are special chemical sensitivi
ties of certain subpopulationa, including the young, to certain neurot<nins andff
other chemicals.* Studies also have shown that the young are more susceptible^
to many carcinogens than are adults, due to physiological differences at tbe^
young compared to the normal adult population and certain other factors."
• Literature regarding drug and other chemical allergies of certain sensitive indi —
viduats suggests that cwtain subpopulationa in the general adult population are^
especially susceptible to certain chemicals.'' Pesticides could be among the^
chemicals to which such allergic or idiosyncratic, highly sensitive reactions nuiy^
'Vpalream Effects of Camino^nic Pesticide Use on Farmers and Farmworkers Are-^
Highly SigmfuMni and Often Forgotten
• A mounting bodv of epidemidogical evidence ahows that farmers and farmworkers .^
are at espedaUy high risk of certain cancers associated with their high exposure
to certain cardnogenic pesticides.^
Thus, in many ways risk assessment, due to data gaps, cannot ftillv consider fac-
tors that lead to substantial underestimation of risks. Indeed, many ot these (actors,
such as cumulative, interactive, and synergistic expoiure and effects, highly expmed
and highlv sensitive subpopulations such as chil^n and the poor, and due to the
impacts oi occupBtional ^poeure, there is no real and readily apparent solution that
would allow us to say with confidence that a pesticide poses a "negligible risk" in
fijods even if one accepts that concept as appropriate. Moreover, this approach fbr
foods fails to consider the substantial upstream effects of pesticides on fumers and
farmworkers. Therefore, a phase-out of the intentional addition of cancer-causing
pesticides to foods, and a phase-in of safer alternatives, is needed.
A Review of Heal World Eiq>osia-e to Multiple Pesticide Reaidaea and Other Potential
Carcinogens from Multiple Sources
It is important to recognize that generally, when we discuss the risks of a pes-
ticide on food, we are discussing onty a very narrow subset of the risks. Moreover
as noted above, EPA's risk as assessments for pesticides generally calculate cancer
risks as assuming that a person is exposed to one pesticide at a time.
'NAS, NBC. Peaticideiia the Diets e^lidiinu and Childnn, at 343-44.
*lbid. at 344.
'Set, e.g.. National Academy of Sdenee;^ Natiooal Research Coundl, Peitiddei in the Diets
^Infimtt and Children (1993); CalabreM, E.J. Age and Suae^ibility to Tadc Subatamxs. (John
Witoy A Sods, 1986); World Heahh Organiiatlaii, Environmental Criteria S9, Principles for
Evaluating Health Siekt firm Chemicals During Infancy and Early Childhood: The Need for a
Special ^mroach, (Geneva, 19S6).
'See, Calabrew, *upra,
'£«, Coaonfl A Douil'a Toxicology, at 16-10.
'For a ■ummaiy of same of this evidence, set, M. Mows, "Cancer In Humani and Potential
Occupational and EnTiroDinenta] Eiponue t« Pesticide*: Selected Epidemiolocical Studies and
Case Report* ■ AAOHN Journal, v. 37, p. 131-36 (March, 1989); NRDC, After &Unt Spring: tlu
Unsolved Problems of Pesticide Use in the United States, pp. S-14 (June, 1993).
DigilizcdbyGoOgle
jntzait, in tfaa real w d we are k11 otpoMd t4
peatidtea ' '
r-caiuing chraaicmU. G«ner«Iiy, EPA hu not MUght
diute the canear rii >■ d bjr the uae in the food luppW of not juit one pe»-
1 but the t^aiif 300 'meart ingredienta' (and an impcWectly ezaminMl large
btr of tnarta," i.e., 'HnertT aa far aa target peeta arc eoneemea. although many
Mae "inart^ ^amicala an quite humanly 'active') EPA hai said that approsi-
dj 70 peatiddee now in uae on food are probable or pouible human carcinogeni.
jOT B KpMt a are cooeemed that thia percentage will grow when reregiitration ii
It dw ia important to reeogniae that food-uae chemicals arc. of course, not the
ohrpMtiddaa to wfaicfa people are expoaed, nor ■■ food the only route of exposure
tm uae paatiddea. Manj of ua live, work, and recreate in locations in which pe>-
iodM an uaad and to which we may be expooed bv breathing, dermallv. end in
w drinking water. Horaovar, then an 63,000 chemicale uaed commercially in the
VS.; tor SM of theae, wa do not have even modeat toxicological data upon which
to bite a^ ■■■laeiiiiiiil of aafKy, acute, chronic, or otherwiae.* Eaamimng a lubael
Dfthe 14% of the noa-peatiGide chemieale for which some toxicological data eaist,
m God many mon euapect carano^na. For example, cosmetics contribute anther
126 poiiible or probable human caninogens."* In addition, then an numerous sir-
Wne cardnogena, carcinogaoa in drinking water (i.e., that which we combine with
w bod when we cook it)," in the work place, in drugs, in tobacco, and so forth.
^larala of azpoaun ta cardnosens in these other media 'especially in the work
plus) an often grealar by aeveraTordere of magnitude. "
w Mseaammta in the peatidde food safety arena generally fail to consider this
'^^. It ia rarely, if ever, explidtlv emphasized, that a VI million risk cited for
* ardnoganic pesticide on food is derived from animal experiments in which the
'"i'Bsla are knowindy exp oaed to no oAer carcinogens other than the ont in que»-
?'**■'* By contrast, numana an potentially exposMl to mon than 60 carcinogens
f^ia fbod (a nun^er that likely will increase when all the toxicological data come
jVGriiham, Health Aspects of the DiipOMl oT Waste Chemicals. 182 ( 1986) (hereafter, "Grii-
''Hiitt A MenlU, Food and Dnif Uw, S19 (3d ed 19911
J .A* of 1981, the Naticnal Aesdetny of Sdenees had identified at least 21 cardnogeni in
T'uikiiif water. Koel It Knunp, "Water Borne Carcinofena: A Scientist's View," in Crandall A
^>e, eda., The Sdentiflc Baas of Health and Safety RegulaUon, at 173, 18042 (1981). "Eati-
?*tea of the riaka (of each these individual cardnogena) were otKained fram controlled animal
~*^diea and apply apedflcally to risks of chemicala in the abaence at other cardncvena. The oisg-
^tiide of aueh efneta cannot be predicted Atun data on individual cardnogena." td. at 182,
^Vlddlng these weh^tad tl^a together would yield an eatimate of the total cardnogenic effect
?.tlieee diemicala. Howew, this would prebably underestimate the total cvdnomnie riak (hnn
J^^inkiitg water sIims the •aUmate would not include the cardnoEenic potential ctf the chemicala
"J drinSng water not yet Identlfled or not yet leated for c»rci nog* ni city. Appmiimatelv 90 per-
''*nit of the total otganie eoatent in drinking water falla into thia category." Id. at 182-83.
f, '-'Oenerally, axpoauie to eardmgena on the Job ii perrmltsd at a much higher level than in
f«od For ttamide, 08HA allows eipoaure to araenic at a level that reaulta in a QRA of 8,000
jP*WeaneenpeFmUlian«nwewlworiun.A5ARCOv. 05H.1,T46F.2d483(9tfaCir. 1984); Hutt
5* Merrill, tupn, at 988. PersiBtant low level
e than intermittent oi
^^MW. Seee
fw "fhe comprdieiuive NA8 report, Conp^ 'Miituret: Mtthodt for in Vivo Toting, (1988)
V»lereaA«r "NA8, Compltx MtxtaretD «t 6, explaina why:
Toxidly testing has traditionally studied chemical compounds one at time, for varioua reasons:
^^ealing with agents sId^ has been more convenient to inveatigatora; phyiiochemical propertiea
^f sin^ agenta wwe oRtti more readily defined* doaage could be more eaaily controlled; biologi-
<^ fkte could usually be monitored in a atraightdbrward manner; concentrationa in air, water,
suid tiasue could be accurately measured; target-or^sn toxid^ was predictable on the basis of
experience with agenta related to the one in question; and relevant data were often available
fnm human occupsUooal exposures.
'*NAS, Complex Mixtunt, at 1, begins as foUowa: "People are seldom expoaed to aingle chemi-
cals. Most aubstancea to which peo|ue are exposed, whether naturally or artiRdally produced,
are mixtures of cbamlcala. Mixtures tbst sre of particular concern indude chemicals generated
in Are, haxardous wastes, psstlddea, drinking water . . .'
FDA has recogniied that *[t]he approval of a cardnogenll does not indude condderation a
the potential intoraetion or synergy betiveen an approved compound and any other substanc
or aubstancea to which oeople are expoaed. Certainiy, the mon appmoed eaniaagenie compootu
titer u the uMelihoodBf caneer iniSiielion ia peopU.' 50 Fed. Rag. 4661
bt A Meirlll, lupra, 900-01 (emphasis added). Thia notion was empb
C^ntinu
DiBiiizcdbjGoogle
90
The introduction to a rwwnt lARC wymotmum on the nit^ect poiDted out that
1in)oet chemical ezpoeuree in the re«l world involve minplex mixturae rather than
dnsle agenta, but the scientific dats-baae for theee mixtures is generated almoat en-
tlrelv horn etudiee of individual agenta.' " While it is indeed true that Tefotimating
the human cancer riaka of exposure to complex mixtures presents fbimidable meth-
odological problems . . . such exposures are taought to account fm' a large proportioD
of cancer*, in perticular because of widespread exposures to such mixtures within.
populationB. '"
short, "good science" should emphasize and d
' ' ' ' ■Tiiifiaia , humane ai
As one expert in Uie area notes:
A toxic interaction is defined as a condition in which two or more ehemicala
result in a qualitatively or quantitatively atterod biological response rel-
ative to that predicted man the action of the individual chemicals. For any
exposure, botn oogenous and endogenous interactions may result in eithw:
(a) additivity — where the confined efiect is the sum of the effects of the in-
dividual a ' "' ' " .■.—.■ . ..
the sum o
component enhances the effect of the other [e.g., carcinogen
initiatarsl; or (4) antagonism— where the combined efiect
sum of the effects of the individual agenta. >''
The eSect will vary, depending upon the particular chemicals In questior
""" feet can vary with the same chemical; if exposure toe"" ' '■' '
o B, the effect can be different than if the exposure if
sized in, Environ Corp., Elements of Toxicolcgy end Chemical Riik Auesunent: A Handbook
for Attorney* and Deciaian Maken (1986), at 63 (emphaiii added):
The buic problem can be atated aimply: we can meanire the riiks poaad by chemicali onlS
under certain highly reetricted eonditioni of expoaure, but we need knowledge of (i.e., [we need
to] aueai) the mki they may poae under conditiDnB of exposure that fall out of the ntnge of
cumnt Tmaturtmtnt capabUiliei . . . The mott Mrtoui pottntuU danger associated with the use of
risk anenment concern! the fitUurt to reccgnat iti HmitatUmi and uncertainties, '
">Viano, Soraa A McMichael, Complex Mixturea and Cancer Itiak, 1 (WHO, lARC 1990) here-
after dted aa 'lARC, Complex Mixturti.'
"Id. at 8.
"Griaham, at 1S3. See alao, HAS, Complex Mixturea, 1-29, 186-201; Kaldor A L'Abbe, "Intex^
action Between Human Cardnogena,' and Williama, "Chemical Mixturea and Interactive Cff*^
cinc«eneaia: In Vitro Studies," in lARG, Complex Mixtures, at 35-43, lOT-12' Hurphv, 'Gener^
Prtndplea in the Aaaeaament of Toxicity of Chemical Mixturea," 48 Enuiron. Health Pcrspeclio^^
141-44 (1983); Chen, Gaylor & Kodell, "Eiplanation of the Joint Riak IVom Multiple-CompouK><*
Exposure Baaed on Sinale-Comwund Experiments," 10 Risk Analysis 286 (1990); Calif. De^^
of Health Servicea, Guidelinea for Chemical Carcinogen Riak AaaeaamentB and Their Sdeiitiz**^
" ■ ■(, p. B-7(1985).
h the aequandng
echaniam of toxic — ,™
mental factora can reault in an increaae in the incidence of aome human cancer* that is great^*^
than that expected &om an expoaure to a aingle carcinogen. The chemical induction or tumaV'
i* considered to be a multi-stage [Aenomenon. requiring either repetitive expiwure to a sinfl^
agent followed by promotion Iran a aecondaiy agent at a later time. Initiation takes place rap-
idly and ii conaidered to be easenlially irreveraible, while promotion may occur months or even
yeara later." (Griaham, at 183-84 (dtationa omitted)
In addition, "[i]t ia commonly believed that... the theoretical effect of two cardnogena actinf
at different atage* can be aubstantially altered by the timing of the two expoaure penods, rtnult-
jng in a ipectrum of riaka ranging ttma additive t« greater than multiplicative,' (Brown & Chu,
'^ditive and MultipUcative Modela and Multiatage Cardnogenesia 'Hieory," 9 Riak Analysis, 9S
(1989).)
"^e concepts of initiation and promotion were derived from empirical obaervations of experi-
mental tumorigenesis ... in which the adminiatration of an ineffective doae of ■ known cardno-
Sn, followed by repetitive treatment with another agent [a non-cardnogenic promoter] elidta
e appearance of many tumon. Application of thia second agent alone causes only a few tu-
mors. (Tro^D & Chang, "Role of Tumor Promotion in Affecting the Multi-Hit Nature of Car-
"^e concepts of initiation, promotion, and progreaaion have evolved to explain the obaervatioa
that tumors could be Induced b^ application of a aubthreshold doae of a cardnogen (the initi-
adon phase) fallowed by repetitive treatment with a noncardnogen (the promotion phage). "fd.
at 262. "If PBB ia given to a rat prior to adminiatratioa of a cardnogen, for example AAF w
DMBA, it will actually protect the animal from the initiating potential of these particular com-
pound*. He same compound, oven in the exact same way, but after initiation, acta
Here we have a real dilemma in that it ia going to be impossible to put a red flag or
Knseii /lag on a molecule juat by virtue of ita atructure. We have to make our 1**1*111111111 In
the context oTIhe biological tMhavior ^the compound. Why [are] these kinds of chemicela actii^
DigilizcdbyGoOgle
One itudy wu oonduetad, for azuiqile, on tha acute tone intermctiona of 13
'n get out of tha conceptual realm and into realitj, that ia. to dat«rmine the ac-
tual interactive efEtet of a given pesticide, at the moat extreme, it would be nec-
oeaaiy to conduct aeparate animal feedingteata with it, plus one other, throuj^ the
60,000 other chemical* presently in use. ilie coat of doing these experiments would
be astronomical. But even then, bearing the coets would only tell us more about the
interactive effect of too chemicals. The coata of conduetinf[ the teats for combina-
tions of 3, 4, 6, 6, etc. chemicals make such testing unrealistic.'''
Condttsion
Thus, there are major uncertaintie* uaing tjuantitetive riak aaseaament for pea-
tiddes, rangjog from the inabilitv to grapple with cumulative and interactive ewcta
of tlie pestidaes we are exposed to dailv, the impacta on eapedally sensitive aub-
populatlona such as diildren and especially poor children, the lack ot exposure data
for key aubpopulations, and the tsilure to consider "up stream" effects on workers
and fanners. Therefore, without the ability to pinpomt with accuracy the actual
level <£ risk posed by cancer causing pesticide*, a ^llution prevention" approach
that seeks to cut off the problem at its source througn the phase out of the cardno-
gens and phase in of alternatives ia vitally important.
Mr. BnjRAKiS. Mr. Feldman.
STATEMENT OF JAY FELDMAN
Mr. Feldman. Good afternoon, Mr. Chairman.
My name is Jay Feldman. I'm executive director of the National
CoaUtion Against the Misuse of Pesticides. We were founded in
1981 to bridge the concerns of farmers, consumers, and environ-
mental interests in an effort to reduce and, where possible, elimi-
nate reliance on toxic materials and promote alternative strategies
for pest management. I'm also here today representing Beyond Pes-
ticides, which is a new grassroots coalition which was founded last
year, a coalition of environmental, farm labor, Etnd sustainable agri-
culture, and public health groups throughout the United States.
In terms of H.R. 1627, we are operating under the premise that
it is wrong at this juncture to weaken a food safety and pesticide
regulatory system that science has told us is already not working.
In the written statement we point to the various factors that con-
tribute to background on this particular point: What are the sci-
entific studies that document that we are deficient as a Nation in
addressing serious problems such as cancer, which strikes 1 in 3,
kills 1 in 4, infertility, childhood cancers such as brain cancers, soft -
tissue sarcoma, et cetera.
Children need to be better protected than the provisions provide
for. H.R. 1627 does not deliver on this need, although we recognize
the improvements over last year's version of the bill.
We believe it is extremely disingenuous to testify before this com-
mittee that it is important to protect children, give EPA the discre-
under one set of comUtian*, and a* antt-pranoter* in one organ lyatam, but
, ^ ■pede^T'jU. at 284.
A tingia promoto' ha* Men uiawn t« intanaUy we effect* of a particular eardnoeeQ by a fac-
tor rf 1 000." Page, Harris, and Bruser, "Waterbonia Cardnoaeni: An Eeanomi*?! View," in
Crandall & Lara, lupra, n. 1, at 19T, 201, dt^ Blntfiam k Falk, "Environmental Carcinogen*:
The Modifying EfTed* itf Cardnogen* on tb* Tfirediald Retpanae,' 19 Arck. of Eavinn. Health,
77»*3 (1969).
"Caaarta and DouU't ToneoUgy, tupra, at 396.
^Testing all of the intaractloni between jiut 10 ehamicali would require 1,013 teita. See the
DigilizcdbyGoOgle
tionary authority to do that, and not provide the resources nec-
essary to achieve that end. Evei^one sitting in this room, previous
witnesses, know full well that both USDA and EPA lack the re-
sources necessary to generate the exposure data that is required to
carry out the provisions in the bill, and therefore we believe if the
committee is sincere about achieving this standard of childhood
protection that the necessary resources would have to be des-
ignated.
The second point I would like to make is that risk/benefit analy-
sis is not a protective public health standard, and to suggest that
it is in the context of this hill, I think, is misleading. Risk assess-
ment methodolc^es for the most part reflect real life situations.
A previous witness indicated the mulUple exposure issue. There
are a whole range of problems associated with nsk assessment that
go to the questions of synergistic effects: the fact that EPA is be-
hind schedule on collectmg the necessary data, the integrity of the
test data, difTerences in professionztl judgment; £ind, finally, the
benefits auEdysis in H.R. 1627 does not consider the full cost of pes-
ticide use.
It has been mentioned previously that low-income consumer
would be adversely impacted by maintaining a Delaney type clause.
The reality is, what happens to farm workers, who are among the
lowest paid of workers in the United States, and what happens to
people that are in low-income communities that are adversely af-
fected by drift and other factors concerning pesticide exposure?
Finally, I would like to get to the Delaney clause in the caate^
of risk assessment. The Delaney clause we believe is a sound ad-
entiflc concept, and I really ask you to consider that in the conte^
of our written statement. Given the history here and the previod-B
testimony you have heard, there are a couple of points that ne&d
to be made.
Increases in technological capacity to detect smaller and smallei'
quantities or levels of chemicals to the part per trillion level or
greater does not negate the critical scientific need to establish a
threshold safety level. This is the point at which an adverse effect
is promoted or initiated, and the fact of the matter is, despite what
I think one previous witness said, we do not know the mechanism
of cancer. I mean physicians can tell us that. The mechanism of
cancer is not known. That has not changed since 1958 and the
adoption of the Delaney Clause. The only thing that has changed
is our technological capability to detect smaller and smaller levels.
That doesn't say that the part per trillion level is not initiating or
promoting. Delaney is a public hefilth provision that errs on the
side of safety, protecting adverse impacts.
I urge you to look carefully at the risk assessment models that
are proposed as possible replacements for Delaney, and it should
be noted here that H.R. 1627 does not define negligible risk clearly;
and, second, the decisionmaking process which is referred to as risk
assessment and seems to have tne scientific mystique about it, as
indicated by a previous witness, comes down to a question of toxi-
cological philosophy. That is what we were told earlier by one of
the witnesses. So we need to consider real life situations, we need
to consider exposure to multiple pesticide residues, we need to look
at a range of factors as to the cnideness of the models.
Finally, Mr. Chairman, I urge this committee not to betray the
basic concept of States' rights that is incorporated into our U.S.
Constitution, l^e proriBion in H.R. 1627 to override the authority
of States to adopt more stringent standards flies in the face of ev-
^Tthing I thinlc this committee would like to achieve, which is in-
creased protection of public health and safety.
We as a coalition believe that we can achieve our pest manage-
ment goals without the heavpr reliance that we now nave on pes-
ticides in our society today. We believe very strongly that we need
to protect the rights of farmers to farm, the rights of fanners to '
achieve a profitable and productive crop, but we believe we need
to take a much closer look than this bill employs and assumes the
need for, the necessity for, cancer-causing and other hazardous pes-
tiddes in the food production system.
Thank you.
[The prepared statement of Jay Feldman follows:}
Good morning Mr. Chaiiman and nwinban of th« Subcommittee, I am Jay Feld-
man, Executive Director of the Natioiu] Coalition Aninat the Miauae <A Peetiddaa
(NCAMP). We appreciate the opportunity to teati^ before the Subeommittae today
on a matter of utmost importance to the American fanner and consumer — food tafe-
^ and peatiddaa.
NCAilP waa founded In 1981 to bridge former, conaumer and environmental in-
tereate in an e£Ecvt to reduce and where poasible eliminate reliance on toxic mate-
rials in peat management lyatems. What link* ua ia a concern for the health of our
Cuniliea and the protection of the environment. Oiu- memberahip apana the 60 atatea
and groupa around the wnld.
I am abo here todn rapreaer ,
eraMToota coalition ofonviromnental, form labor, auatainable agriculture and puUic
health grouf- "*- ^-'••- — — .^.l.-^_- -.w^ t .■..
rapreaenting Beyond Peatiddea, formed in 19M aa a national
,, groupa, di , ... ,.._ .
groupa, have jmoed with Om eoaution and endoraed i(a miaaion. Beyond Peatiddea
- ■-' ttheavoi,* " " ' —
D pastiddc
«lth stand
laoka to prevent Uw avoidaUe real lift diaasters and oompounding economic costs
that result from pastidde poisoning and contamination. Aa a coalition, we aeek
v the purpoaea of this hewing, we will focus on proviaiona in H.R. 1627, the
^ood Quaaty Pnlection Act ^ 1995, that pertain to amendments to the Federal -
Pood I&ug and Cosmetic ArL We are cqierabng on the basis premise that it is wrong
to weakMi a food safe^ and peatidde r^ulatoiy ajratem tlut sdence has told us is
already not prateeting us. In other words, we should be meeting here today to dis-
cuss strenguienlng amendments rather than the provisioas of this bill which will
only serve to weaken current protections in law.
In this context, we would like to share with the Subcommittee some of the the-
matic problems with H.R. 1627. To that end, we believe the following should be eon-
I^ law should be strengtiiened to sccommodate increased sdentifie
knowledge. HJL 1627 ignores recent sdentifie findings linking peatiddea to
adverse Health effects.
Risk-benefit analyids is not protective of public health. H.R 1627 wrongly
embracea titk-bendt analysis as a public health tool.
State and local authority to exceed fiMieral atandarda is essential to good
public policy on health and safel? and democratic ideals. H.R. 1627 betrays
the basic prindple of states' rights.
Weprovide you with the basis of these positions below:
/. 7ne law should be strengthened to accommodate increaaed aaentific hrtowledge.
HJi. 1627 ignores recent scientific findings linking pesticides to adverse health ef-
fects. The sdentifie data suggest that we, as a nation, have a real environmental
health problem that can be significan controlled anid reversed with a dear na-
22-264 - 96 - 4
DigilizcdbyGoOgle
tiooal commitment to altcriMtive pMt mwuigeiaont atratcviM that do not rdy oa
a. Sciiaitifie »tudU» doeumatt a mritnu health and etwinnmental threat from p»
tiddu. We are hne tocU; to wldrcM the Mrioua matter of protecting hunuui hMltfa
•nd the environnunt, wlule enmiiiis that the naceasai^ peat managnmant toola an
available to pect managers. We are having thla discuMion in the cont«zt of increu-
ing peatidde uae and increaain^ reliance on peetidclea. In 1994, over 2 tnlliafl
pounda of peatiddeB were uaed, including conventional pestiddea, wood presem-
QVM and diainfMtanta.i
We believe that the Subcommittee and Congress must addren food WMy and
peatidde queations in the context of human and environmental health, as ml u
•uatoinoble peat manogBment etrategiea. Thia need eziata with a badidrop of ad-
vene human health and environmental effect* that in many caaea ia reaching oiaii
proportionB.
• ^ncer now strikea one in three persona and kiUi one in four.*
• The ratea of illoeea aiul mortaU^ associated with cancer are rising. Devra Darii,
formerly with NAS Board on Toxiadogy and now a senior sdenbfic advisor tJu
SecretaryofHeolthstDHHS, aaidinherOct 21, 1993 congrassionat testtmocf,
"^e found that industrial countries' ratea of cancer mmlaUty increased from
1966 to 1986 for a number of sites, induding melanoma, prostate, non-Hod^ina
Ivmphoma, multiple myel<nna, breast, brain and kidney cancer." "nie NBC loimd
uiat all forma of cancer except lung and stomach aro increamng in people ovar
64 — not attribut^e to increued detection copat^ty.*
• Dramatic worldwide decline in male sperm counts over the last 50 yeara.*
• Reproductive failures in wildlife spede* ranging from alligators in Florida to polu
bears in Alaska."
• Childhood brain cancer," childhood leukemia and soft tissue sarcomaa' assodittd
with home* where pestiddea are used. 1991 National Cancer Institute epide-
miolosica] data ahould the rate of childhood malignandes climbed almost 11%
from 1973 to 19S8— not a function of better reporting."
We do not know as much as we should about the diemieals that H.R. 1627 would
n^Eulate. To err on the side of more use or continued heavy reliance on pestiddea
is to ignore the signals that are crying out to us. One of the most striking draul>
is the potential impact of endocrine-disrupting chemicsls. Louis Guillette, Jr., nSi
a wildlife biologist who has studied estrc^enic pesticides writes, 'Studies using thi>
[systematic methodologies of epidemiolag:^— 'ecoepidemiology^ approach have oaf
provided strong evidence that various environmental contaminants disrupt the em-
bryonic development of the r^roductive system of numerous wildlife species, permt-
nently altering the reproductive capabilities of these individuals."* Numerous pes-
tiddes are included among the environmental contaminants.
b. Children netd better protection. H.R. 1627 doet not delitier on the need to prole*
children. A National Academy of Sdences' report dies defidendes in infbrmstioD
needed to make good sdentific dedaions. With the release of the National Academ;
of Sdences' June, 1993 report, Peattdde* in the Diets of Infanta and Children, the
pubUc once again was reminded of the failure of the U.S. government to adequate!;
protect the population from potentially harmful enwsure to pestiddea. While the re-
port focuses on inadequate protection of children from pestiades, the central condu-
puuiofui/ Ji._. , __.
*I>«vi« Lee Davii, Senior Expert Adviaor to the Auirtaot Secretary for HealHi. Depmlnisnt
of Health and Hunan Services, testimony bafbre the Subcommittee on Health snd the EnTJion-
ment, Committee on Eneny and Commerce, U.S. Houie of RepreieDtativei, October 21, 199S.
*Theo Colbom, Senior ralow. World WUdlift Fund, eongreuional testimony before the Sub-
ccaunlttse on Health and the EnvironnMnt, Cmnmittee on Energy and Commane, U.S. Houm
tf Representative*, p. 2, Oetobv 21, 1993.
■Louis Ouilletta, Sdoitifie Director, Blotechnologlea of the Ecoltwical, Evolutioiury and Con-
•ervatloo Sdences ftogram, Int*nli*dplinat7 Center (br Siotechnolccy Seeearch, Univeiai^ of
noilda (Gainesville}, testimony befiire the Subcommitts* on Health and the Environment, Com-
mittee on Enetey and Commercs, U.S. House of Renreeentativ**, October 21, 1993.
*Davi* JR, ^iwnson RC, Oarda R, Bent* BJ, Turner A. Family peetidde uu and diUdhood
brain cancer. Ardi SnuironnuntaJ Canflun TatkoL 1993;24:87-92.
^Ldss JK, Sariti DA. Home peatidde u*e and diildhaod cancer A caae-eontrol study, Amer-
iewt Journal <^ PlAlic H^M. 199E;8B:249-StG2,
■Aofdn K. A apedsl risk fbr leukemia patlenta.T^ New font rjni««. November T, 1991.
*Oiullette, Jr U. Endoerine-disruptins environmntal eontaminanta and reproduction: lesaons
tnm the itwhr of wildUft. Women'$ Himih Today: Pertpectivet an CurrrrU Remarch and CUaical
Pracdee. Parthenon PuHleation Group, New YoA, 1994:301-207.
byC^Ogle
taaa is ap^icaUa acriMi tfaa (nwral population-^
p«)8ure data and tasting fig paaticide tozidty do n
nil outaide the average. In tbe caae of children, thl
■ tfaa gnmni population-currant nwthoda of generating ea-
* ' " do not adequately protect thoae who
1, thla meane that eipoaure data doee
Dot take into account their diet, which ia dieproportionately compoecd of particular
organ eTstema. In addition, mule the NAS report foeuaas on food anMaure, the au-
thora note that peeticidee are not eimply a food eafety problem." Safe^ ia a gennal
peetidde tcaddty issue, with a need to evaluate all routaa of exoocure.
The repot raiaee Mricua q[ueation« about govemment'a ability to develop mean-
ingful riu aaaeMmeot modela to calculate, with any kind of certainty, the real rieks
that peaticidea praaant In fact the report indicates that the Environmental Protec-
tion AgenCT haa vefy '■"■■♦■^ ability to ensure the public that there can be adequate
Cublic tiealth protection without m^r change* in the way the aseiu? doee businese.
% testimony m the 103rd Congrefls, Clinton Administration omdala acknowledge
the inade<naadaa of the current regulatory system and NAS findings of the need to
overhaul ue regulatory requirements. Aiuninistration otBdala said in congresaional
testimony, 'As adn)owle«lMd by the NAS study, Aill information on consumption
h^its for infimts and children u not up^to-date." '■ Tbtar* is also a lack of analysis
of multiple chemical ezpoaures, synergistic effects, and non-cancer edecta.
Despite limited infbnnaiion, H.R. 1627, is heavily reliant on riak aasesament ap-
a complete program to respond to the NAS concern* about the protection of children.
And while the survey information on childhood exposure to dietary residue* would
help us bett« estimate the risks to children, H.R. 1627 does not provide the much
needed resources to do the yA. EPA and USDA have made it abundantly dear that
the reaourceo are lacking to do the job, and proposals before Congress will cut funds
aigniOcantly, thus making it even more difficult to perform these functions.
L^mn Goldman, M.D., Assistant Administrator for Prevention, Pestiddee and
Toxic Substances said. The report made a variety of recommendations concerning
how EPA evaluates pesticide toiddty, residue levels, and food consumption, and how
this information is used in risk sssessments. The Academys recommendations,
taken as a whole, present a great challenge in terms of higner standards for the
qualiw, quanti^, 8ensitivit)|, and scope of the data the Agency uses in evaluating
naks crom pesticides. This is a formidable challen^, but one we are prepared to
meet." " Unfortunately, H.R. 1627 does not meet this challenge.
The NAS report is just one of many reporta that raises serious questions about
our knowledge of pesbddes and their ^ect on people. >* The eondusion that should
be drawn from NAS and other studies is that we have inauffident information need-
ed to safely calculate the real risk of peetiddes.
//. Ridt-benefit aitalyna u not protective of public health. H.R. 1627 wrongly em-
brttcet risk-benefit analytu a» a public health tool. Regulating pestiddes under risk-
benefit calculations is inherently flawed because of current weaknesses and resource
Utmtations in calculating the fill] range of risks, costs, and benefits.
a. Riak aaaeaanunt methodologut neglect consideration of real-lift e:^aureM to
dangerous peelicidet. Central to the discussion of risk-benefit are questions aljout
riak assessments. The public is told that the chemicals in wide use are tested, sub-
ject te risk assessment, and found to represent an acceptable or "negligible riak."
Generally, people are told that the public is exposed to trivial or trace amounts of
chemicals or that their risk from exposure to a cardnogen is one in a million.
"NHC p. 11.
'» C«rol Browner, Adminirtiator, EPA. Richanl Romlmer, Deputy Secretary, U.S. Departinent
of Agriculture, David Keisler. Commiuioner, Pood and Drug Adminiitration, tettlmany before
Joint hearing of the U.S. Senate Committee on Labor and Hiunan ReKiurce*, and Subcommittaa
on Health and the Enviromoent, Committee on Energy Commerce, U.S. Hcuae of Representa-
tivea September 21, 1993.
I* Lynn Goldman, M.D., Assiitant Adminiitrator, Office of Prevention, Peatiddea and Toxic
Substance*. EPA, teatimcny before Subcommittee on Environment, Energy and Natural Re-
■ourcet. Committee on Government OperatiaD*, U.S. House of Repreientativee, October 29,
1993.
'*Jay Feldman, Executive Director, National Coalition Aninat the Miniie <^ Peatiddea, a
DigilizcdbyGoOgle
Then m two probleou witb tbaae MMctJOM. Pint, in KR. 1627, ' „„_„
di«tU7 riik" ia not definad; it ia iinrUir iriut aaeOy tl of legislation i»i
tonplatM im ixi^giblg. Puither, in the nine braatb. Hi- wcm thia, it at
- mu aitder_wfaidi evm DM^igible risk con be ' ^ (Title IV, Seetlo
'trnmlidAa Cbemical «—aiiee.) SeamiUjr, wbt
tiiiue, the mtrtliodology brinoa with it boom commanplace aaeumptionB about e^N
aure and bmd^ tliat the NAS report haa challenged. In fact, what onerges mu
any inve|^gati(m oT riak aaaaaimcnt is unMttain^, about jvhich much haa bee
■ P)
[I , , _____^__. ., -.„
of Qw typM, piobabilitT, and magnitude of health efbcta aaaodated with a
chemicu agent, of the economic wEtets of a propoeed regulatory action, and
of the extent of current and poaelble fiiture human eqMsurea. Theee prob-
tema have no immediata aolutiona, i^ven the maiv 0P> iu our understand-
ing of tite ceuMl mechanism of caranogeneais and other health effects and
in our ablUty to aacratoin the nature or extent of the effects associated with
specific e^osuree.i*
Tu president ctf the American Chemical Sode^ said, "... riak assessment n
quiree uierences drawn from limited adentific data." ^ A physician woiting in oi
cupational and environmental medicine, Grace Ziem, H.D., writing about multipl
chemical sensitivi^ (MCS), aai^ 'Althou^ initially skeptical that such illness n
tions could occur tulowing low-level chemical expoeure, I became aware that ei _
ing chemical exposure Usuts were sdentifiolly util^ and that no-^feet levi^ ei
trapolated from chronic animal studies were often orders of magnitude below ciu
rent l»nJ exposure limits." "
b. EPA ia behind acHeduU on reregialraiUtn. "EPA continues to fall behind ii
schedule to reregister the IB m^or lawn care pesticides. In the meantime, the pei
tiddes continue to be wplied in larse amounts without complete knowledge of the
safety. Since March 1991, EPA's s^eduled study completion dates for many of it
18 maior lawn care pestiddea have slipped siniificantly. some by as much as
years, according to GAO.'^ The following contributed to delays, according to GA(
need for hi^er level studies; redoing needed studies; time extensions; and, cancer
about pestidde derivatives. Much of the delay seems to be a function of the re{
iatrant foiling to adequately perform a study and registrant delays resulting in tin
extensions. Some delays are generated by EPA.
The same can be said for fbod use pestiddes, most of which are also used in law
core. According to teetimoiiy delivered to the subcommittee in February, 1992,
Enactment of FIFRA '88 was intended to address such concerns [about the
safety of manv existing tolerances] by accelerating the reregistration of
about 23.000 older pestidde products. However, the reregistration task has
proven more formidable than antidpated, and EPA will not meet the 1997
reregistration time frame established by FIFRA '88. In the interim, pre-
viously registered pesticide products may be used on food under their exist'
ing registoation and tolerances, despite EPA's incomplete knowledge of
tlwir human health and environmental effects.'*
c EPA haa changed the baaia of makiTig reregiatration deciaiona from "fully' con
plete to "aubatanHaUy complete data baae. Because of this change, it appears t
though EPA hss been able to accelerate its time schedule. In the cose of 2,4-D, EP
etiminBted the need for a crop residue study to makes its rere^tration dedsio]
saving 21 months, and decreasing the reliability of EPA's dectsions and e~~'"
ments. With Isofenphoe, the registrant made up 24 months ir '" *- -
determined that it did not need spray drift studii" ""' ~*~ ""
and the Illunon of Santy, Ke
-^ „„ured People, PsiticideB and Yc
. . , G.E. (19SS). Corporate influence c
Med. 13:G31-SS9; Ziem, G.E. and CaKleman B.I. (1999
ipeetlvs and current practim. J. Occup, Med. 31:910-91
/.nnnv n... ..i-^y ^j^ ^^ tlussholdK A critjcal anaJy*
liid. Med. 17:727-753.
OAO, AivU IS93, p.I6.
"QAOJnod Scatty; DifpeiUtUa in Aateuing Pftieui* Sitkt and Baufia, February 26. 199:
Thresbold limit valuea: Historical pertpeetlvs and eurrer
and Roadi, S.A. and Rappapert, S.M. (1990). But they
of the documentation of tlirealiold limit valuei. Am. J. Iih
"OAO, April 1993, p.IS
»»GAO, ftod 5o/t(y; Dii
QA{Vr-IlCED-93-33, p. S.
dbyOtXlgle
"Two otlMr pMtieiaM, "■«*'■—*''■"" and OInhontc, imwovwl by 38 utd 13
nMnthi, wp t Uv rtr. riim Jwm 1992, &r ■miW rauon.'l^ EPA hji it will be
uaiag dku on >imiur potticidw «4mo it drops • data nquiranwnt or will procMd
wiUi nngisbatioii Bvon diau|^ tho study baa not bom racoivad. Accordins to GAO,
Ono of tba 18 psatkidaa— (Hjphoaata— ia cumntly in Raragiatration Elisi-
taiU^ Document (BED) pnparatioii. Althou^ EPA had aarliar rqactad a
nnmbar of tfaa nflotm^a environinantal £ata atudisa, it datanninad that
ttw data base far ^Tphoaata was auffidantly complete with the atudiea.
EPA offidala laid ua uat thay may not require the regiatranta to rapeat
the mected stodiea.**
EPA bdd GAO diat tt mi^t make regiatratioii
1996 jBTonndwatar atudy on Diazinon or a cancar ^ .
d. SPA dot* not hmoa admftiati aapoaim data to maM* »aftty daciaion*. In ita Feb-
ruary teatunonj>, GAO indicated that EPA did not have reliable data on the quantil^r
of pesticidaa uaed on Cood eropa. Tht atatamant went even further to say that inad-
equate knowledge s up por ts risk eotlmataa. According to GAO,
Our recant work an EPA's use of USDA's Nationwide Pood Consumption
affect pestidtie rUk eati-
food. EPA esti-
Survegr illustrates bow inadequate knowledge may t
mataa. To aetaUlab aafii levob of paetidde reeiduea
mataa dietary exposure to pesticide reaiduea using
v^, whidiia conducted every 10 year*. However, w. . _
mate of potential buman exposure _to pesticide reeiduea in food isjinceiiain
leuuaest
. , r review of USDA's 1987-
3 survey fbund that it was not representative of the U.S. population be-
cauaa the reaponae rate waa too low. To compenaate for thia deSdency, EPA
is using the older 1977-78 survey data to estimate food consumption, but
his survey may not reflect the current eating habits of Americans. More-
orver, nether the 1977-78, nor the 1987-88 Nationwide Food Conaumption
Survey sampled subpc^nilations, such as infanta and pregnant femalea, in
numbaiB large enoum to permit predae eatimalaa of their dietary expoaure
and, hence, ttT risks to them from pestidde residues. *>
Similariy, with nondietaiy expoaure, EPA has poor exposure data to use for pur-
poses of rer^isbration because uie agency simply assumed that significant expoaure
was unlikely. However, the agency is in the process of rethinking the low exposure
asBumptioa "^n particular, tney mentioned uncertainty about the persistence of
lawn care peaticidea in the environment and the amount of exposure received by
diildren wbo, becauae of greater contact with treated areas, may receive more expo-
sure than previously thou^t EPA is working on better testing and Bssessment
euidelines for all types of residential exposure to toxica," says GAO!^' It appears un-
iikelv that EPA will have guidelines developed before FY 1997, if funding becomes
available. And so, one of the critical elements of implementing a meaningful rereg-
iatration standard— expoaure data — is simply missing or wh^y inadequsto. GAO
recunmenda that a pesticide "should not be reregistwxl for lawn uses unless EPA
is confident that there ia no health risk from exposure, espcdsUy to children.'"
Farmwoiko- protection remains inadeauate under new worker protection regula-
tions that do not ensure that all workers have (Ull information, training and medical
monitraing provided all other workers protected under the Occupational Safety and
Health Act, Our country's "harvest of ahame" must be addressed within the context
of reregiatration to ensure the well-being of those who harvest the nation's food.^
e. Integritjf of Teat Data it StiU an Issue. The EPA Inspector General reported to
the agetU7 m 1991 of inadequate auditing of testing laboratories used by chemical
companies that generate studies uaed for reregiatration. We are not aware of any
followup action resulting from this report that would ensure the public of the integ-
*>GAO, April 1993,0.17.
»'GAO, April 1993, p. 17.
"GAO, Febni^ l»e, p. 7.
**QKO. April 1993, p.36.
"GAO, April 1993, p. 32. GAO ii^, "[U]ntJl tlie new Euidelinai fbr eanducting post-applica-
tion expoaure itudiet and risk SBsssimenti are developed, EPA will not know for certain how
mud) •sposure is awodated with lawn care use of pestiddM and what the tubaequent health
risks really are, espadally fbr childreo."
wAccordioB to ttie GAO, Hind FamuBorkers: Heaith and Weil-Being at Eitk (GAaHRD-92-
46), "Hired tsnnwwlen are not adequately protected by federal laws, regulations snd pro-
grsmt; therefore, their health and well-being are at riu. Hired farmworEeis go into field*
•prayed with pMtiddee, but many have no luiowUdge of the ipedfic cfaemicali they an exposed
to or the potential health effect*. Field unitation on many email ranni may be inadequate, con-
stituting a serious health haiard to hired rarmwoAen on those tanat. Young children . . . may
be more nucepUble than adulta to the bannfU eflecta of peetiddee.'
DigilizcdbyGoOgle
rlhr of tMt data UMd for ravgiBtration.** GAO hu rimilar concerns: 'In our review
^BPA'i regulation of diainfectents, wo found several wesknesses in EPA's data re-
view, lab inapeclion, and data audit programs, which inhibited EPA's ability to en-
sure the quafitsr and integrity of registrant-submitted data. '"^
/ Difference* in profkiwinid judgement led the ataie ofCalifamia, utuUr the ttat^t
Birth Ot/bct Prevention Act of 1984 (SB 9S0) to different ai^ety findinga from BPA.
Theae issues are ftirther clouded by difierencee in professtoaal Judgement. The data
used to register pesticides continues to be generated by registranla. It ia still not
peer-reviewed, and it is still not generally available to independent scientists or tfae
puUic.
g. The benefUi antdyeia in HJt. 1627 does riot consider the fuU coat of peaticide
use. The risk-benefit analysiB, as propoeed in H.R 1627, n^ects to consider the fUU
range of coats assodatea with the adverse public health, environmental and eco-
nomic impact of pesticide use. For example, Section 102. Cancellation (BX6XD) re-
ouirea the Secretary of Agriculture to conduct sn analysiB of the propoeed action on
Uie availability and price of food, as well as "associated sodetal impacts (including
consumer nutrition and health and low-income consumera)," but does not require an
evaluation of the cost of adverse effects. There is increased general understanding
that pesticide use has secondary environmental and economic impacts, whidi som^
researchers have totaled at $8 billion annually.^ Omitting these costs from the cal —
dilations preventa poUcy makers from making economically and environmental^^
sound decisions.
h. The propoaal in H.R. 1S27 to repeal the Delaney Clauae i» not baaed on a toitncM
Bcientific and public health prevenhon principle. In the time since the 1992 Nintfcs
Circuit court oedsion upholding the Delaney Clause, the provision has been called!
outdated and anadironistic bv politicians and industiy interests. However, the law^
is based on the scientific unaerstanding that we cannot prove the level at which ^
cancer cau^ng substance initiates a cancer efiect, although we can determine thB£
a comical is a carcinogen. This distinctian stems from the fact that high dose ani-
mal experimentation can tell us that a chemical causes cancer, but it does not tel/
us the low dose paint at which the chemical has no effect. Given that carcinc^ens
have delayed or long-term effects, animal experiments have never been able to rep-
licate IJie time perimi and low dose. For ell the criticism, the high dose method has
yielded impressive results, proving accurate in the vast majority of cases where
chemicals are known through epidemiological studies to cause cancer in humans."
There is no scientific basis for suggesting that any carcinogenic exposure i«preseoti
a "trivial" or "negHeible" risk. The Delaney Clause errs on the side of public healfli
protection and rightly so.
Increases in technological capacity to detect smaller and smaller quantities (or
levels) of chemicals to Uie part per trillion or greater does not nefjate the critical
scientific need to establish a thrashold safety level. This is the point at which an
adverse effect is initiated or promoted.
Those arguing the Delaney Clause's demise would have it replaced with an unde-
fined 'Negligible risk' standard, as proposed by H.R. 1627. The "negligible risk'
standard is steeped in riak asBessment methods that are filled with uncertainties
and miscalculations as to sensitive population groups, such as children and elderly.
^ In the wake of muor pestidde Isboratory testing scandals involvinf falsifiBd pesticide
health and safeQ' data, EPA's Office of the Inspector Oeneral (IG) has revealed lerious Base
^ , ., „_ s Base
in the agency's Good LaboraUiv Prsctiees (OLP) inspeetian program. According to the IG, £PA
_.j.. __. ■ i._j _^.j_. _..__ I. because. The ' ' * "-
.^ r_ . , awnwomise tL- -, ^.
AceordlngtothelG, "Of the ^,000 studies mmpleted under FIFRA, only 2,268 have ever been
, . . .. joratoiv Frae ... . . . , _
mi^t not rect^niie a bad study when it came across one becsuse. The Agency doei .
standards to deleraune If s *P<ei'Ic GLF deRdency would coi^wbise the validity of a study.'
audited— just under one percent Since the pro^am's inception, only 17 cases were pursued and
penaWet ranged fram 11,600 to $30,000. The IG "bellevels) this low level of penalties gives the
— ong messsge to industry— that the GLF PKiaram is -' - '-'-'- — ■■--'-■ — • "-- -
reiy small penal^. will result from not complying." V
wrong messsge to industry— that the GLF Ptoftram is not b high priority, and no penalty, oi
a very small penal^. will result from not complying." When fauuy or fraudulent data is identi-
fied, It does not affect the registratlan of the pestidde product in queiiion. Instead, manufactur.
•rs are simply granted an Extension to meet data requirements. [Kenneth A Koni, Assistant
Inspector Qenwal fbr Audit, memorandum to IJnda Fisher, Assistsnt Administrator for Pes-
tiddes and Toxic Substances, EPA, "EPA's Procedures to Ensure Qushty Data Under the Good
Lsboratny Practices Fragrant," September SO, 1991.1
*'QKO. Pebruaiy 199270. 13.
■■Hmentel D, Aequay n, Biltonen J, Bice P. Silva M, Nelson J, Llpner V, Giordano S, Horo-
wils A, lyAmare M. Environmental and economic costs of pestidde use; An sistument based
on currently avsilable U.S. data, although incomplete, tallies tS billion in annual costs.
BioScienct. 1992;42(10):760-T60.
"Wilboum, J tt, al, "Response of experimental animals to human carcinogens: an ana^sls
based upon the IARC Monographs programnM," Corcifuigenesia, vol. 7, no. 11. pp. 1863-1868.
DigilizcdbyGoOgle
iption patterns, and other exposures affecting the total
[dual already carries.
H.R 1627 does not address: multiple chemical expoeura through dietar; and
; load that any one individual already i
nondietaiy exposure; limitations of the ne^igible risk standard to quantitatively de-
fine carcmogenic riak; deficiencies in estimating cancer potency; and non-cancer
liaki, lueh u endocrine eytttaa disruption.
• Ruk asseaament modeU are not accurate. Maiw theoretical doee-response models
r carcinoKeneaia have been proposed, each of which leads to a particular
mathemaac form of the dose-reeponse relationship.
• 7'eslin; methodology moAes low aoae effect level unpouihle. Risk assessment is
bued upon two assumptions: First, extrandation of the experimental results of
testa pwformed at hi^ exposure or dose levels to much lower exposures in ani-
mals. And second, extrapolation of these estimated risks Ua low dooes in ani-
mals to risks for humans at comparable doses.
This fiuther assumes that htmians will not be more sensitive to a particular carcino-
gen then animals. And that chemicals that do not cause cancer in animals also
muld not do so in humans. These assumptions simply are not so.
NeverthelesSj^e scientific communis has generally endorsed the maximum toler-
ated dose (MTD) approach to testing for cardnogenid^ in animals, which is then
ffstrapolated to humans, like MTD approach has been endoraed for purely practical
reasons. Acc(Hniing to /saues in Riak Aasesament (1993), "[T]eBts conduct^ at lower
«loees will probably have little power to detect carcinogenic etfocts, unless the num-
ber of animals tested is increased immensely, which would increase the cost of a
ttoassay commensurately; the large number ^animals required for detection of the
■mailer incraase in tumora inofence that might occur at low doees is one of the pri-
mary reasons fbr tise of the MTD in cardnogenidty bioassays."*^
■ Voriotions exist in ausc^Mbility of huTnans to cancer. Both human data and the
results of animal e^niments tell us that individuals varv greatly in their sua-
c^tibil!^ to the eoiMts of cardDogena. But we do not know how to identify
thoee most at risk.'* Not all expoeed people devdop cancer, suggesting a cnuia-
erable variation in susceptibility to cardn^wns (which mi^t or mimt not have
■omethliu to do with gowtics). Not everyone ^qxwed to materials containing
I Ivdrocorbons develops sUn cancer. Not evenrone who smokes develops lung
cancer. Not eveiytme who worited with 2-naphthalamine or benzidine d^relopM
f cancer of the urinary bladder.
Dm dilwnma is that we cannot prevent exposure to ell foreign chemicals. And yet
n do not have adequate methotu of determining which chemicals are cardnogenic
tnd which are 'safe. Therefore, it is unwise for anyone to predict how many eaaes
of cancer will result from exposure of people to a particular amount of cardnogen.
• It is impoaaible to determine •»/% threaluud level* ofejpovtire. A National Acammy
ofSoencea committee on saccharin stated: 'All uiecnetical doee-response modds
have one thing in common, that there is no known uniform threshold dose
bdow which may cardnoguuc response is impossible for all individuals at ri^
Even if thresholdB do actually exist, it is scientifically imposnble to measure
them or to prove tb^ existence."**
It is not poBsQue to conduct plaudble experiments which enable us to establish a
v& Ifareahold for exposure of people to any cardnogm revealed through experi-
Dsnta in nninmlii pew doee-response studies over a large range of doses have been
carried out and in those, mainly with nitnieamines, there have been significant can-
Mr iMponaei even at the lowest doses used, which were lower than those to which
— ». — , ^ >^
n not be eitabliahed. The most difficult as-
I the establishment of a "
imals. According to Liji
nitroeaminea— diethylnitraeamine, dimethyln
aitnaomorpboline— have shown a "significant carcinogenic effect after adminis-
tntion of doses to rats totalling less than 1 miiiigratn during their lifetime, or
less than 5 millignuns pw kilogram body weight lUs equates to a third of a
gram for a human and is above the no-efjeet leveL No tolerable or 'de minimue'
"Hational Rauureh Council, National Academy of Sdeneei, Imiei In RUk AneHment. Na-
Honsl Aesdemy PrsM, Washington, DC., 1&93, p.G.
"Ujiiuky, W. U.S. Health will be Jeoparduml if DeUney Clauie is Abandoned. Chtmical A
tl^Miring Stua, June 37, pp. S6-28, I9T7,
DigilizcdbyGoOgle
%DC.,N
■Uawk,.
Bet. 48:2089-2096. 1989.
doM could b* atablislud fi>r Bitch a aamitagen. Nor ean such on exercise be
miuininirflil Tor any carciDogen without imptMaiblT large and expensive eq>eri-
1 aoitnalt, or in the abaence of deUberete eiperimente in humane."
. _j>ld models ft , . .
contaioB many carcinogenic agents and that the partieuJar chemical in question
may be acting not only additively, but also eynrasistically, over and above the
background. We do know that pestaddea. partinilaily organophosphatae, act
t^nergislicaUT with each other and with otner ^rpea of pesticides.
• £)posu7« to mimipU pesticidt reaidtua ia a reaUfy. An individual product may not
pose more than a iiariigible risk': however, e^osure to numerous fbods witli
pestkide residues will mcrease tlte toxic bodjr burden substantaallv. A com-
prdiensive calculation of the risk fh»n eating a particular product wiOi residues
of multiple pestiddes is not as daiuerous as the risk from eatiiig multiple com-
modities, micb together present a hi^ier risk.
• Synerfiam ofpeatiadea ia not oonaidered. Synergism, or potentiation, involves sit-
uations in which the joint effect of two or more agents is greater than the sum
of their individual effects. InteractionB may occur in mixturea, substances with
more than one component Pestidde formulations themselves are usually cmn-
filex mixtures. Multiple pestidde residues in food are mixtures of substances
eft over from agrieuftural treatments. The problem of detecting interactions is
complex because of the enonnous number of chemicals and comlnnations to
whidi e:q>osure8 may occur.
• Extrapolatum from teat animaU to humtma ia tha currant prttdiea. Using nwinifl
evidence of csrdnogenldty to ban human food additives actually underestimatsa
the problem. As mentioned previously, humans may well be more senaitive to
e cardnogeu than animals. Equally important, however, is that humans are «•
posed to many cardnogens rather than just one csrcinogen, as iitiiTnalii are ax-
posed to in lab tssts. Unlike the rat that is exposed to a sia^e cardnogen, a
human may get drugs, air, water, and occupational exposure Uiced with eaidno-
gens, to say nothing of otlier food additives that msy not yet have been tested
to see if tiiey cause cancer. A little Ut of this plus a little Ut of that seems to
be, at the least, additive and, at worst, synergistic.
• Other facton to consider. As noted above, risk assessments also need to take into
RKUideration spedal groups, such as udldren, pr^piant women or the elderly.
Because of the spedaTsensitivity of the fetus and small children to cardiuvena,
it is most impi^tant to avdd exposing diildren and pregnant women to pes-
tiddes.
The young generally are more susceptible to chemical poisoning becsuse of their
lower levoa (MT detoidfying emymea and the elderly are also more sensitive. Humans
sufiering from liver, ndney or central nervous s^tem disease should not come into
contact with pestiddes. Persons with preexisting illnesses, such as allsrgies, emphy-
sema, asthma, glaucoma or cardiovascular diseases should not be exposed to dui-
gerous chsmicau.
• ConatTvatbx Riak Aaaeaameni Models are Crude. Depending on the assumptions
and models that are used, it has been found that calculated risks can vai; t^
orders of magnitude. Even conservative models may not be as conservative as
commonly beueved. The one-hit model, which is the popular risk assessment
model widely considered to be 'conservative,' is used by the EPA:
The One-Hit Modal assumes that a dngle exposure to a carvinogen may cauae can-
cer. It is accepted practice to rely on animal cancer bioassays in which animals are
exposed at doses tnat approximate the animal's maTimal tolerated dose. The pod-
tive dose is used to preoict or generate a graphical dose-response curve. The shape
of such a curve may vary from chemical to diemical and even (br a single chemical
is not likdy to be linear over ita entire range. Cancer inddence is plotted against
dose of the cardnogen br plotting data points relevant to the hig^ end of the curve,
where doses are h^. llie valid% of extrapolation down to low doses is not easUy
verifi^e, and may not accurately predict the shape of the curve at that end of the
• Public AxailabUky of Data it limited. Often there is only one manufacturer of
a pestidde. Thnefbre all acute and chronic toxid^, caidnogenidt;,
teratogenid^ and motagenidtv studies used to roister the pestidde have betm
Mnaratad in the past ud stUl continue to be generated by tiie manufacturer.
Tbtte itudles have been claimed by the manufacturer to be proprietary and
trade secret and therefive have not been published or otherwise made avaJlaUe
'ConunenU of WUllam UjL
in Externally Andlsd Drugs SI
DigilizcdbyGoOgle
e avidence on which to bu« tha hndc sffecta o:
Th* data hav« not been and still are not KuierHlly available to independent ad-
eotlrti or intaraated mamben of tlie puUic. The Fraedom of Information proceM ia
flMmd by long deUgra and daliberaoons with induatry over the eonfidentiali^ of
Itde haaith and aa£B& atudiaa.
HmMi and aaft^ iMrtiag data ahould not be confidential. Data confidentiali^ pro-
Inbita public diawinJOTt abd debate. Companias ahould not be allowed to make pub-
lic 'data Bummariaa' and prevent maamngftil public anamination of the basis for
Qiir IntarpratatiiKia.
• ERA ojia otiur govemnunta aitd induatry nuMUad the public. EPA has insistad
that it doea not 'approve' peatiddes, but aimply 'rraisters' them. The Food Mar-
kating Inatttute, along with FDA, made tha following incorrect statement: "Ba-
ton a pertkide ii approved for uaa, tbe EPA reqiurca ^Aensive testing and
GuT^
aalMgr atudiaa to damonatrata that the product mrira as intended and wont
Me nnraaaonabla ridu to paople or the environmeDt.'*"
. , in 1986, eoodudad tt>at ^lia puUic recdvaa mialaading information on pas-
.Jehaaarda.''*"'rradegroiV8andatates, with tha cooperation of federal agencies,
hm tonfliaad rather than infanned the public by misinterpreting the facta. Sisk is-
Ui will eontinue to ba distorted by both industn and govenunent under H.R
U2T. EPA often makes the blanket statement that Qie HkelD^ood of carcinogenic ef-
bda in humans from a^Maura to low levels of pastiddeB ia nonezitrteiit or aztramely
hnr. A statwnant like tlua ouf^t not be made in tiie fkce of the paucity of informa-
• SaTacy of product ingrtdierttB underminet public oversight, indmendent anafyaie
ana ooiuumer righi-lo-krtow. All ingredients in peaticida product formulations
and raaulting chemical reaiduas on food commodities should be disclosed to the
public. Prom a puUic safety standpoint, the public (both users of pestiddes and
cmaumeiB of food) has a need to know what chemical^ are contaioed in the pas-
tidde products to which it is exposed.
tn. State and local authority to exceed federal ttandards it etgerttial to good public
poliq' on health and aafety and democratic ideala. H.R. 1627 betrays the basic prin-
^efttatt^right$.
fnaaBpOaa is undemocratic and unacceptable policv and attacks states' rights.
Hw autnoiity of stataa to protect reaidenta is essential to dedsion making in a de-
taoatfcj. It la a^edally important given the flezibilitr provided the rai^atoiy
■inn to engage m risk aaaeasment dedsion making, with a range of posdble as-
nn^i&ons and population noupa. H.R 1627 takes away state authority to set toler-
uxes [Sec 306, amends 4(9(1)]. This is wrong. Federal food aafetv law, whatever it
— natelv looks like, should estatdiah a minimum standard of public health protec-
tioo. We Delieve it is inappropriate for the federal government to lock states out of
tht proce as of protectiiig uieir reaidenta is a manner that is more protective than
tlu bderal govemmeat Citizens have a rig^t to act at the state level to protect
thcmaalvaa, their fiunilies, and their ccmununities. A provisicm in H.& 1627 to cre-
ita "uniformity,* and ttius lock states out of tbe process of setting tolerances when
tey detennine the need, runs contraiy to a long-estabtished relationship between
the federal government aiid the states.
We are fiwed with a fbderal regulatory system that is (Jstling the American public.
EPA has been engaged in a aeries of controversial risk and cancer dassification de-
(Una tor the past decade. Tbe public should not have to depend on a system of
dedsion making that has (ailed to meet its statutory duty to evaluate pestiddea,
protect public luMlti) and the environment, and then deny states their basic right
to protect the haaith and welfare of their residents. Pestidde policy has governed
a mtam that baa been plagued by inaction and inappropriate action in our view.
(Sven this situation, it would be counterproductive to prohibit states from involv-
ing lliemselves in the difficult task of safety deciaions. Historically, states have
■■Food Harketjns Institute in cooperation with the Food and Drug AdminiBtratiDn (FDA), un-
dated. A Coanimer Guide to Food Qtiali^ and Safe Handling; Produce and Pettiddei. Wuhing-
tan, DC.
**QAO. 1986. Noneirieultuna PasttddM: Riika and RagulatioD. Waabinston, DC., GAQ/
RCED46-97.
DigilizcdbyGoOgle
pUtmI • vvT cooAuctivs rola in Mtting ■Undwcb and craitributiiig to EPA's dee
■ion making procMi, u a raault
Inataad of quashing states li^ta, le^ialation should seek to make states partDff
in an effort to address t^** svious nabonal 01"*"* — "* — t:-:j- — * — j — ^ — d-
instance, if we are serious about better undei
tidde problem, our country nee ds a natkmal i^ . .^
evaluating ovmUl dwmical use and mModated advnve effecto. what goes m at flt
local and state leral is importaot to EPA, but wbera there is Gadaral inaction, atata
must be able to act In fact, important infi>rmation does not always make it to Ibi
federml level, as witneaaed bj EPA's $732,000 fine against DowElanco in eariy Vn,
1996 for ito Culurc to report pesticide inddenU. The conqwiqr's rep<Ht of 249 iad-
denta associated with tlw widely used inaectieide, chlorpjnfbe (Duiwan)
after the t«quired SO-day time period and only after a televiaioD '~~~
scheduled to diadoee mam of the a
Similariy, eObrts in HiL 1627 aimed at harmonizing safety standards witfa the
interaatiimal Codex standard takes the concept of preemption to the inteniatiaDil
arena and should be rejected. United Statee sovereisnty to determine its healtli md
safe^ standards unimpeded should be a basic tmet m all U.S. laws.
IV. Condation. Our positiiMU an praeented to the subcommittee in the amtnt
of ezperienGes frcm the passroota on a daily basis. Our positions do not rcpiCMnt
political posturing. Nor do they repreeent a view that promotes an econiHmc idf-
mteresL In &ct, the positiaos NCAHP advocatee grow out of the thousands of peo-
ple, urban and rural, &rm and non-brm, that contact the organizatjm in teirdi
of anawera to queationa about pesticide poisoning and proper^ damage or in u rf-
fort to prevent such ill-eflects. What ia most encouragmg is that w« not Mily bear
about tww our federal r^ulatoiy system has failed to protect public health and tbe
environment, but we bMr about the reaourcriUneas of thoee putting altaroativt
pest management ^rstnns in place eystems that do not rely on peeticiaes.
There are numerous model pest management syatems for fanna, structures end
landacapes. In agriculture, there are many hi|i)]y auccessful sustainable agricutbirel
systems that reduce pesticide dependen^.*^ Organic agriculture has shown itsdTto
be profitable and productive. S<qi>ean gro we rs in Practical Fanners of Iowa have n-
placed the cancer causing hnbidde alachlor with tillage nstems and planting tedi-
niques to shade out weeds. They '■""■■"■*-^ one of tEie 32 eardnogenic pestidte
announced by EPA while iwintaining productivi^ and profitabili^^ — at yields bi^
er than the state average and an average savings of at least Sll.OO an acre.** I"
adwds, paika, al<mg ri^ts-of way and u fbrestiy, altemativefl ta pesticides bin
prov«d suceeaaful. T%e Govenunent Services Admimstration, in its pest control pn*
gram for 30 million square feet of federal office building space, haa reduced pestiad>
uae by 98 percent, through the use of integrated pest management**
Our counby'a pest nunagement qrstema must be reoriented toward pest preven
tion, by deaigning out vulnnabilitiea and stoess in the asricultural environment tU
practices in tbe urban environment that invite pest pnUems. Until we are able ti
do this, we will maintain our current crime onentation toward pest managemai
with an exaggerated need for pesticide use and pressure to accept nigher and hi^
risks because of escalating pest problems.^
L^slation can either help us move down the path to ecological and enviroi
mentally sound sltemativeB or hinder our progress by sending us down the bw
chemicd path, l^e question that we face as a nation is how to achieve our pei
management needs without an umiecessaij reliance on toxic inputs. We must erali
ate legislative prapoaals in this context. H.R. 1627 takes us down tiie toxic chemie
path, promoting continued reliance on hazardous materials that are so often d
SISii"
We look forward to working with the Subcommittee during your deliberations t
H.R. 1627 and expect to see a robust public interest in the outcome of these proceei
ings. "Hiank you.
Mr. BiLiRAKis. Thank you, Mr. Feldman.
Ms. Brickey.
"^ Board on A(ricultun, NatJooal Research CoimdL Altemati** Agriculture, Natioiia] Aea
enn PicM. 19B9.
" FractiealFsniieie of Iowa. Weed Contml Trials. Aiiiei,IA: Frwrticel Psimen of lows, in
■■Graoie A IntsBTatadpeat mananment for bulldiage. Pt$tieuUt and You. 1993:13(2}; 18-2
MShletar T, Coomt S, PeUman J. Unnecaaeary Risks: Tbe Benefit Side of Die Pesticide Rls
Benefit gqu^km. Natitmal Coalition Agsioit OwWnua of Periiddea. 1993.
iiizcdbjGot^le
STATEMENT OF CAROLYN BRICKET
Ms. Brickey. Thank you, Mr. Chairman. It's a pleasure to be
here today representing the National Campaign for Pesticide Policy
Reform which is a coalition of about 60 groups throughout the
country who support the implementation ofnew pesticide policies.
One point I would like to make at the outset is that I believe
that some of us participating in this hearing today are probably
coming from different assumptions about the law. I think that per-
haps some members of the committee and certainly some of the or-
ganizations supporting H.R. 1627 believe that the current law is
adequate to protect the public health except the Delaney Clause is
too strict.
I and some of the others who are participating in the hearing be-
lieve the law is not strict enough as it is and that we need to make
some changes in the law to make it work better. Certainly we have
had report after report done by the GAO and others that tell us
that the law is broken and needs to be fixed, and I refer specifically
when I sav that to the FIFRA provisions of the law which are being
considered by the Agriculture Committee.
I believe the test for this bill as the committee considers it ought
to be whether or not the food supply is safer and children are bet-
ter protected if this bill is enacted. Based on my analysis of the bill,
I would have to say no to both of those questions.
For many years a number of parties have advocated the replace-
ment of the Delaney Clause with a new standard that would apply
to both raw and processed food, but the question has always been,
what should that standard be? Mr. Chairman, the devil is alwajrs
in the details, and we have heard extensive discussion today about
the difficulty of defining negligible risk, for example, in the context
of looking at noncancer effects.
I also believe there is difficult in defining negligible risk at
some level on the part of EPA if^the law does not provide more
stringent requirements than it does here. I believe this rendition
of negligible risk can be interpreted very loosely and weakly by the
EPA, and that we would find it to be a step backward in the law.
The settlement in California v. Browner, which of course is based
on the implementation of the Delaney Clause, provides for rapid
examination and an orderly phaseout of a number of pesticides
that also may cause other health risks besides cancer. Many of
these pesticides we would consider to be priority pesticides that
EPA should be looking at some time ago in the reregistration proc-
ess. I would not agree that these pesticides constitute a risk to the
food supply until EPA has fully evaluated them and made some de-
cisions.
What would happen, if this bill is enacted, to the chemicals that
are named in this settlement? I believe that many of them could
remain on the market indefinitely even if they are probable car-
cinogens already classified by EPA, and I think that would be a
bad result for the public health.
The bill attempts to amend 30-odd years of law in the FFDCA,
and the result will be more carcinogens in the food. We can argue
about the strength or weakness or potency of each one of those car-
cinogens, but there is no doubt that cumulatively that is what
would happen. It is also unclear how this new standard would be
DigilizcdbyGoOgle
104
applied to noncancer health effects, as has been discussed exten-
sively here today.
I also believe that the bill does fail to adequately protect chil-
dren. I think there are a number of roadblocks to protecting chil-
dren that Erik and others have mentioned, but I also believe that
there needs to be dear and articulated standards in the law that
would require the implementation of the NAS report Instead, this
. bill does not require a specific finding that a pesticide be safe for
children nor does it require that the specific recommendationB of
the NAS report be implemented. I think that is a problem.
I also believe that pesticide exposure could be reduced or avoided
if safer alternatives are adopted hy farmers. I believe that as a pd-
icy this Congress should do everything it can to further that goal
and make it happen. How can we bring new products and new
technologies on to the marketplace if we keep all the old tech-
nologies out there if all the old products — ^whicn, frankly, in many
cases are much cheaper, I can understand the economics of this for
farmers — but how are we going to get the newer, safer technologies
on the market if we keep all the old products in the status quo?
That is the issue, I think the most important policy issue fadng
this Congress that this committee needs to examine very carefully,
and I would urge you to cooperate with the Agriculture Committee
to do everything possible to further the development and the die-
semination of new technologies and off-the-shelf technologies that
may already be available tnat farmers could be using and give
farmers the opportunity to promote a safer, higher quality food
aucmly than the one we nave now.
Tnank you.
[The prepared statement of Carolyn Bhckey follows:]
Mr. Chairman, and diatinguiBhed members of the Committee, thank you fbr the
opportunity to tesli^ today on HR 1627, the Food Quaiify Protection Act of 1996.
_ 1 am Carolyn Bricicey, Executive Director of the National Campaign fbr Pesticide
Attached to my written statement which I request be inserted in the record is ■
list of our members.
The Campaign favors basic reforms to the pesticide laws. First, the moat toxic
pesticides wnich may cause cancer, birth defects, neurolo^cal damage or other prob-
s should be phased out of u
children should be protected from hannfiil pesticide exposures. A key way to m«at
this goal is to implement the National Academy of Saencea report, "Teaticidea in
the I^te of Infants and Children." Third, farmers must receive the proper instruc-
tion and incentiveB to use new pest control technologies that are non-chemical,
wherever feasible. Technology transfer ia critically important, and the U.S. Depart-
ment of Agriculture should oe in the fore&ont of develapment and dissonination of
new technologies.
When it comes to reforming pesticide policy, it seems like a very long and winding
road to me. I have been a part of two legislative efforts — one successful and one un-
succeasfiil — to try to change the way the law works to make it better.
The unsuccessful effort, in 1986 represented an attempt to develop consensus be-
tween public interest groups and the chemical indust^. The aucceesfiil efibrt in
1988 consisted of changes to the law to eliminate a few of its mJost antiouated foa-
tures and to give EPA the resources to reevaluate hundreds of older pesticide ingrv-
dients-^nany of which do not meet today's health and safisW standards.
This testimony focuses on proposed amendments to the Food, Drug and Cosnwtie
Act, but the Campaign also is concerned with the amendments to tbs Federal Inanri
DigilizcdbyGoOgle
Quae shortctmungB. The program operates on a tz«adiiull throu^ which the same
health and safety issues are revisited time and time again with little resolution or
dari^ to protect public health. For example, mce a serious health question is
ntoM, it may take 7 or 8 7earB-~or even longer — to get a decision about the pes-
TMenta a straightforward evaluation of a regulatoir system seriously out of sync.
'Die distinguished and diverse Academy committee cnaracterized the pesticide t«uer-
ance nstem as inadequate to protect children and prescribed a senes of steps to
nuke it more protective. To date, EPA has been woning administratively to incor-
ponto some of these reeommendationa, but much more iweds to be done.
A study conducted by the Environmental Working Group (EWG), Peatiddea in
Guldrtni Food, documented for the first time the prevalence of multiple residues
in gjiif^ foods, and showed that it is not uncommon for children to eat single pieces
of fruits or veietoblee with 5 or more peaticidee on them. This study provided docu-
nantation of the Academy's report and pinpointed one of the m^or defects in eur-
rmit pMticide law — EPA regulates pesticides as though people are exposed to them
one at a time.
lUi atudy Illustrated the severity and imbalance of pesticide exposure early in
life, abowing that up to 36 percent of lifetime exposure to some carcinogenic pes-
tidoas occurs 1^ age 6. The risk is a result of disproportionately heavy early enw-
ture to eight carcinogenic pesticides routinely found in just 20 miits and vegetobles.
Tba average child could exceed EPA's "acceptable" lifetime level of risk by age one.
A subsequent EWG study, Washed, Peeled — Contaminated, showed that even food
that had b*sn processed for consumption contained multiple pesticide residues, thus
reftiting the common adage that you can wash pesticides off your food.
Todav, this Committee is examining the provisions of H.R. 1627, and it is the
Campidgn's position that the Committee should find this bill seriously lacking.
HR 1S27 does not implement the NAS Committee'$ recommendations and doea not
guarantee protection for children. We therefore strongly oppose its enactmertt.
• It does not require specific protection for children.
• It does not ensure tiiat exposure to pesticides at legal limita is safe for children.
• lo bet, HR 1627 does not implement a single finding of the NAS Committee re-
pint that requires EPA to change the way that tolerances are established; it
ooes not require an assessment of expoaxn from all sources, as recommended
by the Academy panel, nw does it include any special mathodologies or safety
betors to protect children, as recommended by the NAS panel.
Instead, we support provisions to effectively implement tlie Academy's report to
tlu itillest extent possitile, including the development of special methodologies and
Hfa^ factors that protect children fiom all routes of pesticide exposures. Because
of multiple exposures on food and from other sources, many children reach lifetime
e^otiire levels before the age of 6 or even by age one.
In its consensus reporl National Academy of Sciences committee on pesticides in
tbt dieta of inGanto and diildren found the entire pesticide tolerance and nsulatory
qvtem lacking, and particulariy inadequate to protect young children. The Academy
ecnduded that "tolerances are not baaed primarily on health conaiderationB'' and
that "the current regulattnr system does not specifically consider infants and chil-
dren." To address these failings, the committee recommended "that EPA modify ite
dednon making process for setting tolerances so thst it is based more on health
Mosiderations than on agricultural practices," and that specific changes be made to
protect youn^ children.
The committee made clear that children need special protection from pesticide res-
idues in food. Specificallv, the committee recommended that "in the absence of date
to the contraty, there snould be a presumption of greater toxid^ to infante and
children." To account for this likely increased sensitivity the committee urged that
the 10-fold (actor traditionally used by EPA and FDA for fetal developmental tox-
icity should also be considered when there is evidence of postnatal developmental
toxicily and when data from toxicity testing relative to children are incomplete.' In
wldition, the committee cited the common occurrence of simultaneous exposures to
difliBrent pestundes with the same toxic effect, and recommended accounting for mul-
tiple exposure in regulatory risk assessmente.
DigilizcdbyGoOgle
Plnallj, Uw NAS '*——'**** left no doubt about the basic goal of povtidde regula-
tion aa It nlataa to food renduea: "Children should be able to eat a healthfuTdiel
GontaininK Wal renduea without enaoeehing on safiity nurgina. Thia goal ahouU
be kept t&u?
HR 1627 do«$ nothing to changm tht airrent pamdigm of continuing peaticifU um.
The current pestidde regulator* syat«m is built on the notion of mawimiim acce^
able risk. Hie goal is Dot to produce abundant and afiordable fi>od using the leut
amount of peatiadee poasiUei rather it is to set and allow nia»lnnini acc^>table lar-
ds of human and environmental eiqwaure to hundreds of pesticides in thousaiidi
of fi>rmulated pesticide products applied to hundreds of food and feed crops. Hh
foundation of mia paradigm is the untenable notion that scientists and regulatoia
can accurately aaaeaa the risks from residues of 20,000 different formulated p»
tidde products all interacting in the environment and the human body.
Not onlj is the baaia of this process hidily implausible, it is extremely ezpenmve.
It provides no incentives for agricultural production innovation, and ulowa mas-
mum opportunities for delay. It is extremely bureaucratic, unpredictable, foumM
on misplaced burdens of proof, and divorced from mai^et forces. It captures aU of
the bad elements of failed regulatory polides in other areas. It con be rightly chu- :
acteriied as "end of the pipe' regulation for food.
HR 1627 tnakrinea into law aUoftht negative featurtt of current polidea.
Nothing is done to assist or encourage farmers to adopt new technologLes that
could promote sate food and water, as well as reduce farmers and their woiken' a-
poaure to many hazardoua pestiddes. Indeed, HR 1627 continues down the current
negative track that threatena wcn-kers, consumers and our environment Beyond ita
general flaws, we oppose HR 1627 for many specific reasons. Some of the most im-
portant are as follows:
HR 1627 ts a poor bargain for the public health.
HR 1627 repeals the Delaney Clause of the Federal Pood Drug and Cosmetic Act,
the most protective preventive public health standard in federal law. It is replaced
with the weak, ineffective, and entirely subjective risk benefit standard curreiitl;
contained in FIFRA. This standard has proven over at least three decades to be
crippled and ineffective. The staMMing number of years it take's EPA to act on an;
single pestidde health threat w^ illustrates this point. It makes much more senae
to enact a strong health-based standard that protects the public and processed food
than to replace a strong standard with a new weak one such as the one propoaed
in H.R. 1627.
HR 1627 codifies in law the current regulatory bias toward agricultural beneflta,
and fails to acknowledge the need for greater protection of the public health, as rec-
ommended by the NAS committee repwt. HR 1627 epedfically allows economic ben-
efits to formers to justify public health risks in excess of the level determined as
negligible by the EPA In other words, the bill establishes a negligible risk standard
ana immediately provides a major loophole to it.
HR 1627 doet nothing to reduce the use of peaticidea.
On June 25, 1993, the Clinton Administration announced an historic shift in pes-
tidde policy, dedaring a commitment to pestidde use reduction and the promotion
of sustainable agriculture, HR 1627 does nothiiw to advance this goal. Why not help
farmers get off the pestidde treadmill instead ofencouraging the status quo?
HR 1627 weakens currently inadequate atandarda far food toleraneea.
The EPA currently establishes food tolerances by adding up the risks presented
by all food uses of a pestidde. HR 1627 appears to weaken this standard by requir-
ing that exposure calculationa be reduced to a single peaddde on a single food. HR
1627 fiirther does not respond to the recommendations of the NAS committee to in-
dude all routes of exposure (food, water, garden, and home applicationa) in the es-
tablishment of food tolerances.
HR 1627 removes state authority to set pesticide residue tolerances to protect the pub-
lic health.
In this caae "uniformity" may mean weaker standards. Former EPA Adminis-
trator William Reilly called the states 'laboratories for iimovation.'' When state gov-
ernment deddea to exercise its authority to protects its citizens, why does it have
to come back to the federal government to ask its permission? Why are states' rights
valid to weaken the law, as is being promoted in other drcumstances, vet cannot
be used to strengthen public health protection in this case? It appears to Em a maior
zed b?tjt^^^^^5
AHtu Policy t» Nteckd to Rtduet Pt$tiatle Utt and PmmoU SiutainabUity.
All food isoduetioii and pesticide rwulabny polidea should work coherently to-
nrd tiie msw goal: producmg food with the lust amount of pecdddes poasible, and
ihan wp»pri«t« and reuonable, no pMtiddee at ijl. This got! should be accom-
pUtsd at the least coat to taxpajren, consumers, and faimeia.
Uanf fiumMS have alreajr phased out or eliminated their use of pestiddes. They
Mr that virtually any food can be grown without pesticides. They believe tbeir
mUi •wI that of their famlli** Justified the change in their farming practices
tiUA haa alao raaulted in safer, hitter quali^ food.
signsd ^MdJEically to protect duldreo and other sensitive or highly exposed
• IMM must embark on an initiative to provide pest control alternatives to grow-
ers ot acopa moat dependent on pestiddes that present the greatest lisks to
human hMlth and the environment.
• CoDsiatent and enfin-ceable market incentives that reward growers for reduced
ind low pestidde use must be established.
HK 1627 aocompliahes none of these goals, and erecta significant obatodes to their
adusvemuiL We therefore strongly oppose its enactment.
Mr. BiLlRAKlS. Thank you veiy much, Ms. Brickey.
Mr. Vroom.
STATEMENT OF JAY J. VROOM
Ur. Vroom. Thank you, Mr. Chairman.
tm pleased to join my fellow environmental interest groups here
in this final panel. I would like to point out that, in my role of rep-
rewotatlve of the manufacturers of crop protection materials, that
we indeed have an interest in serving not only the interest in grow-
ing fbod but also we have discovered, as the marketplace has sig-
naled ov^ the ^ears, that there is money to be made in serving the
interests of society and better protecting the environment and pro-
TiiUng greater assurances of protection of public health.
I womd observe that there is precious little left to say in support
cf ER. 1627 so might I just say dittos or perhaps even meea-rattos.
^ith regard to some other items that have been discussed
thm^hout the course of the hearing here today, I heard a lot of
amversation about the so-called court settlement between NRDC
and the agen^ with regard to the big Delaney lawsuit. I think Mr.
Burr in particular raised that question earlier. The simple answer
IB that the reason that the agency chose to accept that settlement
and go to court and get the court to agree to that settlement is that
^ expected further litigation and this was an easy way to avoid
having to make tough decisions, and, in fact, put yourself in the
place of the agency regulators today. They are by nature risk
averse and would like to transfer risk decisionmaking somewhere
else.
We go to the question of why no answer on the NFPA petition.
Again, it is because NRDC would sue them if they gave a logical
answer. It will be very interesting to see what kind of answer the
^ency does give on the deadline this Friday to the NFPA petition.
However, instead of answering the NFPA petition in a logical and
Bcience-based manner which tney could do and be sued by NRDC,
my industry and the owners and registrants of the products that
DigilizcdbyGoOgle
will be threatened to be taken off the market will be forced to liti-
eate each and eveiy one of those tolerance revocations. Whidi is a
better choice and use of Government resources? Being sued by
NRDC and other plaintiffs or being sued by dozens of manufactu^
ers of crop protection products? I think the answer to that questicm
is, pass n.R. 1627, put Delaney behind ub.
It was also noted earlier a problem that is articulated around the
issue of the NFPA petition — the abilitv of regulatoty agencies to
never get around to fmswering that kina of a rwulatory process pe-
tition decisionmaking authority — and I think that speaks volumes
in terms of the need to maint^ the aspects of the Administrative
Procedures Act in this title and other titles of this bill related to
FIFRA, which has also been discussed here earlier today.
I think at issue before this committee is both the science-based
regulation of crop protection products that are currently on the
market and available for use in American agriculture tod£^ as well
as the development and future of creative, newer, better producU
for tomorrow.
Today, with new crop protection product discove^ to mai^
time lines taking up to 10 years or more, the ^ear 2060 and its 11
billion population of the world is but a hop, skip, and a jump away.
I believe that H.R. 1627 will set the framework for my industry
and all of agriculture to continue to invest to meet the enormoiu
challenge of feeding the world today and in the future. A world, a
hungry world, Mr. Chairman, is watching and applauding your
leadership.
Thank you very much.
[The prepared statement of Jay J. Vroom follows:]
Mr. Chajnnan and members of the Subcommittae; Thank vou, on behalf of the
members of the American Crop Protection Aasodation (ACPA), for the opportuni^
to r^iieter our nippOTt for the extensive improrements in our food safety laws of-
fered in the new Hit. 1627, The Pood Quafitr Protection Act of 1995.' The Amai^
ican Crop Protection Asaociataon ia the not-finvptoflt induatr; asaodatfani of U.S.
manufacturers, formulators and distributors of a^icultural crop protection produda.
Membership is composed of companies which produce, distribute and eell virtually
all of the active compounds used in crop protection in the United States.
For the past four years, ACPA has joined with scores of other food and agricul-
tural inteteats— at national, state and regional levels— in support of such reform of
our pesticide and food safe^ laws. Many of these groups are active in the 200-plue-
member Food Chain Coalitioa
Last Besaion, 224 Members of the House of Representatives coaponsored aimilar
reform l^pslatlmi, along with 25 sponsors in the Senate of a parallel appraaA.
The new hill has been continuously honed and refined— based on inmit from con-
gressional, r^ulattny, agricultural and environmental sourcea— to fiutW reflect re-
alistic reform measures to enhance our nation's food safety needa. We believe that
the time to act is now.
The new bill is aimple but not shnplistic, a low delayed strengthening of the na-
tion's premier food saie^ law. At the heart of H.R. 1627 is reform of the regulatory
approach, allowing modem science to be applied to the establishment of pestidde
residuea; of implementing a single nedlgible risk standard (or both raw and proc-
„ ■■ ■ . ^ « that pesticide ttderencea must
.e adequate to protect public health. In particular, the law 'directs that toleraneea
must adequately safbguard the health of uitknts aiM children." For too long, the ree-
onunendatioi) i€ the natun'a moat preatigioua actnntiflf! MsaniBation liaa gona
Digmzc^GoOgle
IfmiMnnM adratiflc, agricultural, Ibod procMaing, haalth, madlcal and nutzition
enva ansa Qiat tba fime ia now to modernisa Delanejr. EPA Adminiatrator
Bnnnwr, oarad( liaa stnaaad tba need for iamrovemeDt. as have many of the na-
tfan'a leading newq^^Mn. Ear ioatance, in Ita M^ 26 editorial "ZMO-IUak non
Sdntea,*' tlu SaeramMrOo Bm' aaid about the Delancgr Clauae, in part". . . The strict
Mmdard does not reOect modem sdentiftc understanding about vdiat kind of reai-
JDM *nriif"T can aafaly tolerate. In many caaea, it placea a huge burden on growere
■ml prooeeaon while providing little health benefit to conaumerB.'
Ttw fiec reoommeiida that Uie law be made to ". . . confonn to what we've learned
itait human ttderances of pestiddes-^iot on arbitral? standard pegged to what we
M not know almost 40 years ago."
Diiattty Ii^>m U B—tntial
PasHge of this new Ic^slation has become even more unportant— and more ur-
fmt-^n this session of Congreea becauee, under court order, the EPA has been
mndated to strictly Interpret ibt Delaney Clause, even though the court acknowl-
dtaed that ita rigid, lero-standard may be out of date and called upon Congrese to
refitrm the law. As a reeult of the court^s dedsion, EPA will soon oegin to revoke
toleraneaa fi>r uaaa on appttadmately 100 crops of some 37 peatidde producta bene-
fidal to tlMir production.
AccOTcUng to such leading experts as Leonard Gianeesi, of the Center for Food and
Aarieuhnral Polky, who have examined the isaue and fi-om whom you will hear
', this is certain to drive up producer and consumer costs, decrease yield and
tj of fruit and v^etable crope, and increase U.S. consumer dependence on im-
dfitod.
PntKtion oflnfiinU and Chiidrtn
Two years ago, the National Academy of Sdence, In its Paticides in the DieU of
InfiaiU and CnUidnn' atudy, outlined a mmiber of recommendationB regerding food
•ui^ and peaUdde bderance. ACPA takes this report seriously, and so does H.R.
lear.
Hie Food Quali^ protection Act of 1995 provides even fiirther attention to infanta
tnd diOdren, as well as other sensitive subgroups in our population, as rec-
anmended by the NAS.
, ER. 1627 directs EPA to address areas where data on theee sut^roups are lack-
ing or where current testing is inadequate to address dietary exposure to pestidde
Miduaa. At the aame time, the biU aUows ftezibilitaF m that EPA can use the latest
■dnljltc ei^ertise in Its delibentions, rather than M locked in to lenslation whidi
ndifiea acience, and soon becomes obsolete — such as we've found wiui the Delaney
CUuss.
American conaumers demand (and have come to take for granted) safe, afibrdable.
parted fix
American conaumers demand (and have come to take for granted) sale, anordable,
abundant aupplies of a wide varied of food, all year round. With the most innova-
^ productive Cumera and (bod induction system in the world, they are assured
"mat boun^ every time they step into their local supermariceta. And it coats us,
}ple
tr pecvM pay. Sine
dnqiped^SOpei
herehaa been a o
„ * -0 percent
Hure haa been a corresponding increase in life expectancy over the same period,
^ttm a little more than 60 years at the turn of the century to well Into the late 70b
^^Owadays. In Pealicides in the Diets oflnfiuOa and Children, the National Academy
^ Sdencea attributes in part such improvements in public health to pestiddee.
^oot the incei>tloa of modem crop protection technology in the 1940s, crop variety,
'ulds, availabili^ artd aSbrdabiu^, especially of frmts and vegetaldes, have in-
'^ktued dramatically. This la why we call today for refbrm. For modem acience. For
* stronger food aafirty law that "C. . by rMnilatlOD aeta forth Gutors and roetfaoda, in-
S4uding tests which are appropriate for Qie determination of dietary riak and most
^Uely exposure, fbr the determination of negligible dietary riak."
Hie issue in the legislative debate invdving benefits doea not question whelhn
%he uae of Mstiddes Aoa benefits, tar it cwtainly does— but raUier how data on pes-
tddde beiufits should be used to determine accratabill^ of tmy potential riaks, now
vme product should be used to determine aeemtabili^ of any potential risks, how
■ "-—'^"^ .... ^.Yia tnottier, and how one product o
DigilizcdbyGoOgle
110
Aa part of the r«gi«t»tion process, cuirent law properij provides for the evahia-
tion 01 the risks om benefits of a p^tidde. H.R. 1627 contmuee that provision, an
inclusion which we wholeheartedly endorse. A fair evaluation of any risk must in-
clude an assessment of the benefit to be derived tmm risk acceptance and manue-
ment Ignoring benefits places decision-makers with "one arm behind their bacEi'
in that the decision is put out of context, and the true understanding of risk is dis-
torted. , ._. .t^
AGFA, along with the Food Chain Coalition, supportohe principles for evaluatii^
the risks and benefits of pesticide residues contained in H.R. 1627. The approocE
the risks and benefits of pesticide residues contained ii
is Cur to rtffiatrants, protects consumers and recognises xim reaaoneo, uuonnea as-
dsioDs must be made with flill awareness of both benefit and risk.
Even so, this provisfon could be improved by clear articulatioD of the kinds of ben-
efit data needed to facilitate EPA daoaioD-making. Development rf better infonna-
tion on pesticide use patterns— beyond the tnajor crop*— also would be helpfiil. Such
improvements in the quali^ and ciuantit^ of pesticide use information would bolster
public confidence and allow risk-benefit Mcisions to be made more easily.
Iniegrattd Pe$t Management
ACPA and our industry continue our strong support of measures to sustain and
bolster Integrated Peat Management Howev^v IPM does not and cannot meu
abandoning chemical pesticides. The success of IPM depends on the continued avail-
abili^ ana safo, responsible use of a variety of efiective pest controls.
Our member companies have developed methods and recommendations for use of
their products in concert with cultural and biological pest control. New produds
have come on the maritetjuid many more are in the research pipeline, which will
further enhance Cumers' IPM performance.
According to Crop Production and Crop Protection, a comprehensive 1994 Btuij
of eatiiiuted ^obal losses in major food and cash crops hy leading agricultural re-
searchars at the Univoaities oi Bonn, Hanover and Christian-Albrechts, in Ger-
many, Integrated Pest Management "combines care and concern for natural le-
sources ana the environment with responsible and economic use of modem methotta
to produce safo and wholesome food." It accounts for all "known factors," indudfaf
"location, crop rotation, tillage ayatems, soil fertilitr, irrigation practice, ener^ utili-
lation, seed selection, plant nutrition, and crop protection (bioloKical, physical and
chemical)." The authors conclude that IPM "refMveenla a logical way forward be-
tween the extremes of ultra intensive agros y stems and low output organic farming'
The United Nationa, the Worid Bank and other worid bodies project that by 24eO
dobal agriculture must be able to provide for as mai^ aa 11 mllion pw^Ie, mtk
Tut cropland and each perton demanding better, more nutritiout diet* tfuin thou
aoailaolc today. Experts agree that without continuad invesbnent in mod^v am
protection tecwtdogies (in both enhancements to existing products and in new proo-
uct research), vields of the worid's mijor food crops--Tice, wheat, com and soy-
beans — would lall dramatically. So<alled "minor crops" could suffer an even larger
production setback.
Harmonization — Global and Domealie
We endorse the efforts of H.R. 1627 to address the important role which inter-
national harmonization of tolerances can ■ ' ' ■ ■ ' — '
confidence, world wide. This provision o
worid trade of U.S. form production.
Tolerances established by the Codex Alimentarius Commission are subject to
standards which are, generally, as strict— and in some esses more strict— than those
of the United States. Where possible, EPA should harmonize our tolerances with
those set by the Commission. Where departures are appropriate (either higher or
lower), EPA should be able to support such departure with reKable adentific data
and rationale.
Similarly, the promotion within the United States of national uniformi^ for UAer-
ancee will lead to increased public protection, and confidence in the safo^ of the
food supply. ACPA supports the concept of national uniform tolerances for pestidde
products to assure that &esh produce and processed foods are treated under the
same pestidde residue limits in every state, enhancing public confidence and inter-
state commerce. With limited exceptions, based on good sdence, states should be
preduded from setting tolerances which difier fivm those established nationally.
Concluston
Let me reiterate. Food safety reform is needed now. The 37-vear-old Delaney
Clause is a four-decade throwback to the days when sdence could measure, gen-
icdby^^lgle
advanced even further. The Delanej Clause imparts a dtoke hold on progress and
aafo^ in the supply to consumerB of our nation's food.
Data on children's diets must be updated, and additional information obtained on
dietaiy exposiuvs to further ensure protection.
Benefits consideration is essential to a sound regulatory process goreming crop
protection.
Uniform regulatory processes — domestic and international — are essential key com-
ponents of a modem approach.
At issue are both tiie sdence-based regulation of crop protection products cur-
rently approved for U.S. agriculture and tne development of creative, newer, better
products for tomorrow. With new product discovery-to-market time lines today tak-
ing up to 10 years or more, the year 2050 is but a hop, skip and jump away. H.R.
1^7 will set the fi^mework for industry and all of agriculture to continue to invest
to meet that enormous challenge.
The world — a hungry world — is watching, and applauding, your leadership, Mr.
Chairman.
Tliankyou.
Mr. BiLiRAKis. That is quite a responsibility.
Mr. Feldman — Etnd with all due respect I ask this; please accept
it the way I mean it — is your organization opposed to the use of
all pesticides?
Mr. Feldman. No.
Mr. BILIRAKIS. No.
Mr. Feldman. I can embellish on that if you would tike. I stated
our goal for you so that you know we are not trying to blindside
the committee or suggest that you know we are not above board
in our goal and mission. We believe it is our duty as an organiza-
tion, and we believe, in the public interest, this Congress and the
Government should seek to make available to people the safest pos>
Bible technologies to assist in a productive and profitable food pro-
duction system, and the question is, how do you deflne safety, real-
ly is what it comes down to.
We have in our membership people ranging from sustainable ag
to integrated pest management, organic fanners, who believe that
cancer-causing pesticides are not necessary — no processors, I
should add — who believe that cancer-causing pesticides are not nec-
essary to a profitable and productive food supply. In fact, some of
the staff up there can verify that we bring some of these farmers
to the Congress once a year and have met with Mr. Roberts to
share with them the fact that there are profitable farmers growing
row crops, cotton, a whole range of commodities without a depend-
ence on pesticides, and some of the commodities you heard that
were dependent from previous witnesses on cancer-causing pes-
ticides, wheat in Kansas, there are alternatives in those very com-
munities, in those very States, that are not reliant on those mate-
rials.
l^at is what we are after, Mr. Chairman. We believe that there
UB some honest fears out there on the part of the agricultural com-
munity that the lack of access to these chemicals will hurt them
economically, and therefore there needs to be assistance to those
farmers. But we also believe that this committee is hearing from
a lot of vested interests that have, with all due respect. Jay — that
have a vested interest in selling chemicals, and that is not nec-
eaaarily the farmers' interest, and that is what we are trying to get
oiganizationally.
DigilizcdbyGoOgle
112
We are not out to take cancer-causing chemicals off the market
tomorrow. We simply want to get to a point where farmers are
using the safest possible tools.
Mr. BiLiRAKis. Mr. Feldman, I was trying to figure out if there
was anything at all about the bill that you might like, eind there
is one area when you talked about the pesticide tolerances for safe-
guarding infants and children. You basically accented more re-
sources, the need for more resources. So are you satisfied that the
provisions of the legislation are basically adequate for that purpose
but that more resources are needed, more money, more personnel?
Is that what you are saying?
Mr. Feldman. Well, again, as I read the language in the bill, it
seems that this is an exposure provision in terms of generating
health and safety data to make a determination on childhood expo-
sure.
I think Mr. Olson's testimony indicated and conforms to the NAS
findings that there are a number of other issues that really need
to be addressed such eis developing organ systems, impact on devel-
oping organ systems being a big one, multiple exposure to chemi-
cals, carcinogenic chemicals in particular, so that I think you are
right in the sense that, give EPA the discretionary authority to do
something and let them go ahead and do that. But given the reality
of limited resources and a whole bunch of competing priorities, un-
less EPA is instructed to have very specific standards and guide-
lines for attacking this problem, a simple direction in this legisla-
tion to collect exposure data will not ensure that children are ulti-
mately protected.
So it is a step, it is an important step, and I don't want to negate
that as an important step, what this bill does, but I think we need
to go beyond that if we are to achieve the goals that I hear mem-
bers on this committee want to achieve.
Mr. BiLiRAKis. Thank you.
Ms. Brickey, you mentioned the new processes out there, new
equipment, new chemicals, that are available to the farming indus-
try, but that they are holding on to the old and not allowing them
to be even considered. What do you suggest there? What do you
have in mind?
Ms. Brickey. Well, all I can really suggest is what I have heard
over and over from farmers who tell me that they want to change
their practices and they are not sure how to do it, or there is too
much risk involved, or they don't know how they are going to ez>
plain changing their practices to the bank when they go in for a
crra loan.
But farmers who have changed their practices also say over and
over that in many cases they had to play detective and learn what
was out there themselves. Or an even better way has been hiring
private crop consultants who come in and help farmers figure out
how to change their practices, make it their business to know what
are the three different ways you might accomplish the goal of grow-
ing this crop, and they have been able to use those techniques pret-
ty successfully, hut it is not widespread enough. There are not
enough farmers doing it, and I don't believe there is enough en-
couragement coming from the Department of Agriculture or enough
Digilizcd by LjOOQ IC
4ii-
113
1 — d oro hip coming &x>m the Department of Agriculture to make
timt happen.
Mr. BnJRAKIS. Okay. That is what I wanted to hear from you.
Thank you very much. My time has expired.
Mr. Burr.
Mr. Burr. Thank you, Mr. Chairman.
Ms. Btickey, let me follow up on the question from the chairmfin.
What would you surest to encourage new pesticides on the mar-
krt? I think you said that we need to get rid of the old and bring
in the new. What specifically would you suggest that we do? Would
jvu suggest that we streamune the approval process?
Ms. Brickby. I think there have already been some efforts made
to streamline the approval process particularly for biocontrols and
some of the new alternatives that are out there. I think, again, how
quickly EPA can act on new technologies depends on their re-
sources. They have had to shift resources from one area to another
depending on what the Congress and the public emphasizes at a
particular point in time as important. I think that if tney had more
resources I'm sure that they would tiy to look at more new alter-
natives more quickly.
But I also want to emphasize that the Department of Agriculture
needs to play more of a role in helping farmers learn about
nonchemical alternatives, new cultivation techniques, and other
wmrs to grow crop that may not involve these chemicals we are
talking about on the Delaney list. I think that is the way we need
to go.l think that is the way fruit and vegetable growers need to
go.
Mr. Burr. I don't know that the North Carotina apple growers
would buy that though ailer the experience they just went through,
and it is ray understanding that the only thing that can solve the
foneus problem is a chemical. So, you know, I'm not sure
Ms. BRICKBY. Well, it depends in certain situations on whether
there are truly no alternatives available, and I will concede to you
that at some point in time there will be circumstances where some-
one will have to sinr we don't have an alternative available right
now. But I really believe that once we can identify those situations.
If you are talking about phasing a chemical out of use over maybe
a &-Tear period, there is time to develop these technologies.
Ifr. Burr. Given that you would suggtest that we go through this
process of looking at eveiy alternative, is it wrong to think that we
ou^t to look and use the best science and the best analysis on the
pesticide side, which I think some of you on this panel suggest that
we shouldn't be spending the time on that?
Ms. Brickey. I think we should be spending a lot of time in look-
ing at these chemicals, on what the health risks are and how seri-
ous they are. I think beyond that we have got to look very candidly
at what kind of alternative technologies are out there and avail-
able. This is not something, frankly, EPA has been able to do very
effectively by itself, and the history of this issue at the Department
of Agriculture is not very bright either.
Mr. Burr. Let me ask Mr. Vroom to comment on any of that he
Would.
Mr. Vroom. On the question of regulating the risk?
Mr. Burr. Correct.
DigilizcdbyGoOgle
Mr. Vroom. I think the a^ncy has done an adequate job over
time. Certainly there are wnnklea and points in time where, you
know, individual products get caught in that purgatory of science
not being able to make a clear deasion, and, again, you come back
to regulators being risk averse, preferring to put off until tomorrow
a decision that otnerwise they could make today with existing in-
formation. I think we find for pesticide registrants a continuing cy-
cling of the agency fisking for one more study before they will de-
cide on a use decision or a full registration of a product.
I think the system works pretty well. It can always work better,
and there can be more room for greater market incentives to come
into play without having to put an absolute drop dead kind of a
mechanism in place that runs older products off the market pre-
maturely.
I think the marketplace can be allowed to woi^ very effectively,
Again, the marketplace is today, through farm customers that we
respond to, sending signals for more environmentally safe products,
products that biodegrade more rapidly, that have less chance for
drift, and, overall, protect workers and human health in general
better. So the marketplace does send those signals.
Mr. Burr. Would your membership agree with Ms. Brickey that
we have tried to streamline the approval process?
Mr. Vroom. There have been initial steps made and some bene-
fits realized already in terms of fast track approval for lower tox-
icity products. Is it working in a way that has nad a significant na-
tional impact so far? No. Again, because the agency does not have
those resources, and I would again point out that the agency has
spent an incredible amount of resources defending itself from litiga-
tion in the last few years, and those resources could have been
spent doing other things proactively.
Mr. BuRH. Certainly we find that to be true in other agendea.
Mr. Feldman, just a follow-up to the comment. You made a state-
ment that we should be concerned with farmers and the process,
fmd I'm curious, just from your Etssociation, should the consumer be
thought of in this process? Should we be considering the consumer?
Mr. Feldman. Sure, definitely. Obviously the question is whether
the committee needs to establish a health-based standard that in
the process protects consumers as well as farmers.
Mr. Burr. Do you personally — in your association, do you have
trust that the EPA can confidently go out and protect the health
of the citizens of this country?
Mr. Feldman. The current system right now is not protecting the
health of consumers nor the health of farmers. In fact, a tann-
er
Mr. Burr. I'm talking about the agency.
Mr. Feldman. Right. So the agency with responsibility for imple-
menting and enforcing existing law does not, in my view, provide
adequate protection currently. I think to answer you question
Mr. Burr. Do you have any scientific studies from our organiza-
tion that would prove that the EPA has
Mr. Feldman. Well, in my testimony I cite internal reviews by
the inspector general, for instance, on tne laboratory audit prograjn
which shows that EPA is ill equipped to ensure the credibility of
the data that it receives, the underlying health and safety studies
ly »^»t^^P^W
116
which are lahoratory animal studies. I'm not doing that primary re-
search obviously, but this is an inspector general report, and the
same is true for inert ingredients which are a major part, as you
know, of pesticide product formulations that the insp^^r general
says are not adequately tested to protect the health and safety of
both fanners and consumers, anyone that comes into exposure with
the material.
What I WEis going to say relating this to farmers is, there is one
&rmer that comes to mind in North Carolina, a nursery grower
who used a pesticide, benlate, which was mentioned earlier today,
as one of those affected by Delaney, and lost his nursery. He at-
tributes the loss of his nursery— this is a North Carolina farmer —
to the use of this product and in trying to get information on what
EPA knows about contamination about that product, cross-contami-
nation with other materials at the point of manufacture, what EPA
is doing to evaluate levels, breakdown products. There are unregis-
tered products that have been found in this, an unregistered prod-
uct called fusilizol which is found in benlate, a cross-contamination
possibly with sulfunurea, which is a very potent herbicide. This is
a farmer who is frustrated because he trusted the registration proc-
ess and he has lost his nursery. So that is what we would like to
prevent through this sort of discussion so that everyone is pro-
tected.
Mr. BURn. I would certainly suggest that I would like to see that
brmer protected.
Mr. FELDMAN. I would be to happy to talk to you.
Mr. Burr. As well as those who are out of business because they
have lost their crops in North Carolina and in Virginia, in the bor-
dering States, where this fungus exists, and that we elected offi-
cials owe it to the constituents to present something to them to
solve the problem that protects the health of individuus and works
on good science and not on emotions.
I thank the panel.
Mr. BiLlRAKls. I thank the gentleman.
Dr. Cobum.
Mr. COBURN. Thank you.
Mr. Olson, let me just follow with you a minute. I have read the
NAS recommendations, and we have had testimony by three sepa-
rate people that would disagree with your interpretation of what
this bill does with respect to the NAS, and I don't have a large con-
tention with what the NAS says. Is it your position that this needs
to be absolutely spelled out in the bill rather than to give the
EPA — Fm not talking about funding — but rather thui to give the
EPA the flexibility to do that, yes or no?
Mr. Olson. It is our position that the bill should spell out that
the Academy recommendations must be followed, but simply saying
that and not changing the FIFRA Codex override or the benefits
override doesn't do anything.
Mr. CoBURN. Okay, but that is not a yes or no answer, right?
Okay.
Mr. Feldman, you alluded a minute ago to pesticide data on drift
and farm workere. Would you mind forwarding that to my office?
Mr. Feldman. I would be happy to.
DigilizcdbyGoOgle
116
Mr. COBURN. I would like to see that and the study done to that
And I want to follow up on one question that our cnairman asked
you. Can }rou name a pesticide presently that is sold that you <x
your oraanization would consider safe?
Mr. Fbldman. Pesticides that we consider
Mr. COBURN. Safe?
Mr. Feldman. Acceptable under
Mr. COBURN. No, I said safe.
Mr. Fbldman. Biological pesticides for which we know the inert
ingredients we consider safe.
Mr. COBURN. I'm talking organic pesticides.
Mr. Feldhan. Well, these are r^stered as pesticides.
Mr. COBURN. Ok^, Fm talking organic pesticides, Vm not talk-
ing biologic pesticides. Is there an oi^anic pesticide which your or-
ganization would consider safe? Is there any?
Mr. Feldman. I guess I can't answer that question. Let me ti;
to answer that question in context. There are pesticides which we
consider acceptable in various pest management scenarios.
Mr. COBURN. That are organic?
IAt. Feldhan. That are organic pesticides.
Mr. COBURN. Fine.
Then I want to follow with one last question, and Fm not harping
because basically I'm really interested in health and safety as a
fhysician. I'm worried ^bont this concept of safest at any cost, and
think that was — you know, I want to have an understanding of
where you are on that. Is there one small amount of cost that is
acceptable, one small amount of risk anywhere that is acceptable
for a pesticide? Can benefits ever be used to consider coming off ab-
solute safety to allow some area of less than absolute safety? Is
there a position that your organization would find itself in to where
that would be acceptable?
Mr. Feldman. I think that is excellent question, and I think the
short answer to that is yes. The long-term answer to that is in the
context of a clear evaluation of the range of alternatives, and that
is what is missing in this process.
If we adopt this legislation we are setting in stone a standard
that we believe allows too much risk without an adequate evalua-
tion of whether that is necessary risk.
Mr. CoBURN. Okf^, but the real crux I want to get to is too much
risk. Where is the scientific data that says that is too much risk?
"niat is my real question. I want the risk to be low, but I want to
see the data that says it is too much.
Mr. Feldhan. Excellent question. You heard toxicologists today
talk about risk assessment, and the word they all used was "uncer-
tainty."
Mr. CoBURN. No, they all used "negligible risk," the two that tes-
tified here.
Mr. Feldman. They also used the word "uncertainty."
Mr. COBURN. But they both rMognized and said they would be
happy with the word "negligible risk."
Mr. Feldman. I understand that, but then when pressed and
asked about risk assessment modeling, everybody that testified
used the word "uncertainty." The question is where you want to
put the burden. Do you want to put the burden on the individual
cii!yf5^(^Qlc
who is exposed or the &rmer and say you must assume the uncer-
tainty associated with the inert ingredients, with the fact that we
dont have multiple modeling for multiple exposures, ¥rith the fact
that we don't have modeling for sensitive population groups, with
the fact that we don't have food residue and nondietary exposure
cumulative effects?
Mr. COBURN. Let's assume that we are going to take NAS and
include that. Now say that in the context of including the NAS rec-
ommendations within that. Say what you just said again, because
in fact we will consider those things if in fact we foUow the NAS
recommendations, correct?
Mr. Feldhan. If in fact you follow the recommendations, correct,
«tcept for synergistic effects and except for inert ingredients, which
are two mojor exceptions here. The reality is, if cost is an issue tiie
cost problem is on proving the safety side. "That is the problem. If
cost is really cm issue for this committee, which I believe it Is, then
the question is, how do we come up with all the money necessary
to assure the consumers, your constituents, that their children are
not going to be in that risk factor, that their children are not going
to get this brain cancers or the soft tissue sarcomas or the leuke-
nias? What you are telling your consumers is, you are going to
have to live with this level of uncertainty because we believe it is
necessary to food production, and that is where we have not proved
the necessity.
Mr. CoBUSN. That is right That is where the discussion is in
terais of whether there should be or should not be a tradeoff in
that area.
Mr. Feldman. There is always a tradeoff. The question is, are we
getting to a national goal with a health-based standard that allows
111 to ensure the people we work with that we have done the best
possible job we can to get the farmer the tools he needs to prevent
riik and to prevent adverse effect.
Mr. COBURN. And that goes to the point, safest at what cost, and
that is the real issue, safest at what cost.
Mr. FeldBiIan. Can I add one more thing you mi^t want to con>
sider on this?
Mr. COBUKN. Well, I would like you to do that, but I'm out of
time so I would have to defer to the chairman.
Mr. BiURAKis. Without objection, you may, but keep it short.
Mr. Feldhan. Yes. Cost is a very big issue, and most of the cost
we focus on is the cost at the grocery store to the consumer, and
that is an important cost. But there is also a larger cost that the
Congress, especially this Congress, has focused on, and that is the
cost to the taxpayer, and the reality is, what really needs to be
done, for the farmers, for the consumera, and overall is to look at
the cost to the taxpayer of using pesticides versus the cost of the
alternatives, and taat is where you will find with ground water
contamination, drift— you know, there is a lot of property damage
to Ceumers who are suing all the time because of pesticide damage.
There is a study whicn we cite in the testimony. It talks about
$8 billion in costs a year, done out of Cornell University. That is
iiiiat this Congress hiss an opportunity to look at: How do we re-
lieve the taxpayer of the costs of production methods that are un-
DigilizcdbyGoOgle
118
neceasarily dependent on toxic inputa? And I think there are great
opportunities there, and I appredate your queBtions.
Mr. COBURN. Thank you.
Mr. Chairman, I just wanted to add one thins for the record.
Earlier today it was cited that benzene and formaldehyde were con-
sidered inert ingredients. I don't know an organic chemist any-
where that would consider benzene or formaldel^de inert.
Mr. Olson. That is exactly right, and that is why we are con-
cerned that EPA's current policy in the current law would consider
those inert ingredients.
Mr. COBURN. But I wanted to make that clear for the record.
Mr. BnJRAKlS. I thank the doctor.
Dr. Ganske.
Mr. Ganske. Thank you, Mr. Chairman, but Fm going to forego
any questions since I had to be absent for a period oftime.
Mr. BiLlRAias. That being the case then, I declare this hearing
at an end, and, again, I appredate very much the last panel par
ticularly being as patient as you have been. I appreciate your nelp,
Thank you.
[Whereupon, at 1:45 p.m., the subcommittee was adjourned.]
[The following statements were submitted for the record:]
I Km Wuren E. Stickle, Prccident of the Chemical Produeen uid Difltributni Ai-
wdatioii (CPDA) end I would like to mibmit the fbllowins Btatement for the rectri
regardins the food ufMr proriBioiia eontained in Title Iv of H.R 1627, the "Food
Qiudity Protectian Act of 1995.'
By way of intatiductiOD, CPDA la a voluntary, non-profit membenhip aaaodatioii
conaiBtiag of about 90 mnniieT companiee oigued in the manuiaeture. formulatlcn,
distributum and sale ot aooM $3.5 ullion wwth of products uoed on fbod, bed and
fiber crops, and for lawn, garden and turf car«.
We at CPDA would like to commend Cbainnan BilinJds and membera of the Sub-
committee on Health and Enviranment of the House Conunace Committee for hold-
ing hearinga on the (bod safiiW provisicms of this bill. We at CPDA believe it is tima
to move forward In revlrin^ tne outdated Delaney Clause so that pestieidB nsidnas
are regulated in keying with modon science and technolop. We believe that HJL
1627 oETera a fair and reasonable approach to the r^ulatton of peatidde rasidusi
foods — an approach that is based on sound science rather than pubUe
"nfueledbyenr '■ " "" """ s— -.i.-! .__.l___«._ _^___
nuspercept
tidae use i
I terms of ensuring a wholesome, hralthy, nutritious and affordable fi
reign Agriculture, chaired t^ Representative Bill Emmon (R-MO) repeated
out the food safMy provisions cS H.R, 1627. We at CPDA urge members of this Sub-
c<nnmittee to join with their colleagues on Chairman Emerson's panel in adopting
this important legislation.
My comments today will include a discussion of CPDA's sbong support for the
amendments to the Federal Food, Drug and Cosmetic Act (FFDCA) contained in
Title IV of H.R. 1627 which allow the EPA Administrator the discretionary author-
i^ to determine what is a n^igible risk in setting tolerances for pesticide residues
in foods and direct the Agency to take into consiaeration the important benefits of
pesticide use. The flexibility built into these amendments will ensure that EPA does
not become bound t^ rigii numerical limits which would preclude the consideration
of the countervailing benefits of pesticide usage and prohibit the Agency from regu-
lating pestiddee according to the best available sdence. We at CFDA Delieve that
the fi>od safety provisions of H.R. 1627 will permit the EPA Administrator to
prioritize more serious risks and thus allow for the more efficient utilization of
scarce Agency resources. My other comments today will convey CIDA's support fbr
igiiil^dbyGoCl^le
THE NEED TO REFORM THE DELANEY CIAUHE: IMPACT OF LE8 VB. REILLV
The U.S. Court of Appeals for the Ninth Circuit ruled in Let v. BeiUy on July 8,
1993 that Section 409 of th« Federal Food, Drug, and Coometic Act, the "Delanejr
Qause', requires EPA to apply a "zero-risk' standard for carcinogens when setting
pennisaible tolerances for peatiddes in processed fbod.
The Lea ruling could have a diaastroua eflbct on the abundance and safety of our
tuition's fbod supply and the agrichemical industry as a whole. The decision could
lead to the cancellation of a number of different pesticides and hundreds of different
uses which were previously approved by EPA.
In 1956 Congress passed the Delanv 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 mirUmu standard
fbr peaticide residues in proceased food.
Under the de minimu standard a tolerance was granted if the human dietary risk
from a peatidde was so remote that the threat of contracting cancer was "at most
n^igiUe.' The Ninth Circuit, however, has interpreted Uie Delaney language
Iwnd to induce cancer" to mean no traces of eardnagens in residues for processed
bod, regardless <tf how borderline the response in teet animals or how marginal the
risk may be to consumers.
EPA Administrator Carol Browner has stated that the Agen^ is implementing
the court decision although the Agency continues to believe the pesticides involved
"^oee only a ne^iglble risk to pubUc health' and that a negU^le risk standard
nflfleetts] sound public polinr and sdence while at the same time assuring the over-
all (afis^ of the food supply."
The 'zero rial^ standard is simply unwoAable for establishing reasonable risk
enluation. When Ddaney was enacted in the late 1960'b, the usual scientific testing
■tandards measured in the parts per million. Scientific detection standards now
L measure in the parts per trillion and greater, resulting in the detection of carcino-
pta which present at the most a remote and ne^^gible threat to the puUlc. Under
I itrict zero risk standard, if any testing results show minute levels of cardnocens,
ngardless of how negligible the assodated risk of dietary exposure, EPA will not
ncM«' or grant a fooause tderance for the pesticide. We at CFDA believe that
it u inappropriate to use 1960'a sdence to rwulate modem chemicals.
A mass revocation of these pestiddes wiU ukdj lead to fruit, grain, and vegetable
price increases and a decline in the quality of our fix>d. A subsequent reduction in
the consumption of these products by our dtizens could lead to the erosion of our
badflt and the nubritionu integri^ of our diets. The American Cancer Sodety
itnagly maintains that Americans need to double their present consumption of
hiits, vegetables, and fiber to reduce the incidence of various lypes of cancers. Im-
plementation of a "lov-rial^ Delaney dause would therefore likdy increase the ind-
dace of cancer across (he country.
Uoceover, according to the National Cancer Institute, there is no sdentific evi-
dence that ingestion of pestidde residues on &uits and vegetables causes cancer in
bnman beings. Medical experta agree, the benefits of eating fruits and vegetables
b outweigh any potential risks.
To illustrate the low levels of risk associated with dietary tttpoeure to pestiddes,
i40-pound diild could eat 340 oranges every day for the rest of his or her life and
nm not consume the amount of pestidde residues found to cause health problems
iBliboratotr mice. By the same token, a 160-pound adult could eat 876 pounds of
bwcoli, and a 20-pound child could eat 873 apples.
Hie EPA has a vast wealth of resources, personnel, and scientific knowledge it
IMS to draft pestidde poli^. As a federal agen^ it has the regulatory discretion
tolntctpnt statutes in order to effectuate this pohcy. EPA has long determined that
I Sugtigihia risk" standard most effectivdy protects the health of the American
wwmnar and maintains the abundance otmir nation's fbod sumily.
la the absence of l^iislative intervention, EPA is bound to miplement the strict
fntMpntltion of the court dedsion in Lea v. ReiUy. We at CPDA believe it is impor-
tiat to mom fbrward with a legislative fix to Delaney as qtiickly as possible to avoid
As canMllation of numerous pestiddes that help keep our food supply the safest
tnd moit abundant in the wond. We believe that the ne^igible risk provisions set
Ml in UR. 1627 offer a good remedy to the present Delaney dilemma.
DigilizcdbyGoOgle
TOLEBANCE ^'ANDARDB
We at CPDA sbvngly support the food safely proviaionB contained in Title IV of
H.R 1627. The bill nould emAt a tingle negligible risk atandard fbr tdenutcei it
pesticide residues in raw cammoditaas and processed food. In so ddng, HJL IBSI
would permit the presence of a pesticide raaidtie in a processed fbod made tnm t
raw agricultuial commodl^ as long as the coneentratitMi of the pestidde reiidtu ii
the processed food when ready for ccmaumption or use is within the tolnanee lindb
established for the raw fbod. This pnvisioii of H.R 1^7 allewi all foods contaiidiv
pesticide residues that are within a taderance to be considered saft, and not adulto-
ated. CPDA believes that this provision is important in that it sets iMlh ont, nni-
fiirm consistent standard for both raw and processed fbods.
We at CPDA strongly support the creation of a sin(|le negligible risk standard fi>
peetidde residues in estaUisning tolerances for proceMed foods and raw agrieultunl
cnnmoditiea. Under cun-Kit Senion 408 of the FFDCA, EPA sets tolerances Bxjm-
tidde residues remaining in raw agricultural commoditias. Under Section 409 d
FFDCA, EPA sets fbod additive tolerances for peatidde residues that c(«ccntnt« in
processed (bods above raw fbod tolerances, or are the result of pesticide appUeslioB
during or after food processing.
In establishing pesticide tolerances, EPA utilizes a conservative set of assunffi-
tions regarding dietary eraosure to pesticides. These include assumptionB thst- 1)
the pestadde is applied at the hij^ast apidicstion rate allowed by the product Uhel;
2) toe aop is treated the msamum number of times; and, 3) only the mimnmB
permissible interval is sllowed between applicationB.
However^ experience shows that the level of pesticide residues found in foods da-
dines signiBcantly from the farm to our dinner tables. In its article entitled, "Iba
Life Story of a Tomato," which appeared in the May/June 1990 issue of EPA Jov-
nal, the authors writ«;
"[Tlolenutces are intended to apply to treated agricultural commoditiei
when they first enter into commerce, starting at the '&rm gate'... By defi-
nition, tolerances represent residue levels that are protective of pi^dic
health. As our tomato story suggests, however, pesticiae remdties are gen-
erally reduced at each step between the farm gate and the dinner table so
that they are often well below tolerance before the comnMdi^ reaches the
consumer. And in a m^ority of cases, washing, peeling, and noma cooking
of foodstuffs also serve to reduce any remaming residues in consumer
foods... As a practical matter, tolerances thus represent 'upper limits' of
pesticide residues that rarely occur in ready-to-eat lood commoditiea.''
We at CPDA agree with the authors of this EPA article.
Currently, under EPA'e "coordination policy," if a processed food tolerance is need*
ed but is prohibited under the Ddanc^ Clause, the corresponding raw food tolerance
is not peiinitted. In California vs. Browner, a lawsuit concerning pesticides and the
Delaney Clause, the parties sought a court order requiring EPA to revoke a number
of raw food tolerances (Section 408) associated with processed fbod taderances (Sec-
tion 409) whidi are barred by the Delaney Clause. On February 8, 1995, the U.S.
District Court for the Eastern District of California approved a settlement agree-
ment in California v. Browner, Under the consent decree, EPA will be required to
set policy, in accordance with specific timelines mandated by the court, that could
leaa to the cancellation of a significant number of uses of approximately 37 pes-
tiddes and fiirther review of more than 40 others. In all, about 80 raw food tmer-
ances that are assodated with existing or needed processed food tolerances could be
revoked. Moreover, under the consent decree, EPA must dedde whether anv of ap-
prradmately 60 processed fbod tolerances are sutoect to revocation under Delaney.
The impact of the California vs. Browner consent decree, in combination with the
July 1992 Les v ~ ~ " "
disruption of thii ,. , ,___
control tools available to U.S. fanners. Less choices mean higher prices for both tiie
American consumer and the American producer of food.
We at CPDA believe that the fair and reasonably constructed fbod safsty provi-
sions of H.R. 1627 will help us svert the potential food safe^ criaie and manet dis-
ruption that will surely ensue if we do nothing.
NEGUQIBLE RISK AND CONSIDERATION OF BENEFITS
Under H.R. 1627, EPA would be responsible for definine negUgible risk in li^t
of evolving sdence, taking into account different routes of exposure to a pesticide
and sendtivitiee of population subgroups. This provision, supported by CPDA, re-
quires the development and implementation of procedures to ensure that pesticide
iyQ^>0^e
bderances adequately Bafsguard the health and lafMy of infimU and children. Ai
Bucfa, it reaponda to the recommendationa made to' ^^ National Acadenqr of
Sdancoa in ita report 'I'eeticidea in the Diets of In&nta and Children."
la otho' praviaions of HJL 1627 EPA would be required, where reliable data are
•mHatde, to calculate the dietary risk poaed to food consumen by a peeUdde on Oie
baiia of the percent of food actually treated with the pesticide and the actual red-
dm levela of the pesticide that occur in food. In particular, tite EPA AdministiatcK'
would be raquired to take into account aggregate pesticide use and residue data col-
loeted bv the V.3. Department of Asricufhire. We at CPDA are porticulaiiy support-
ive of the requirement in H.R 1627 that EPA establish tolerancea on the basis of
Ott percent m food actually treated with the pesticide and the actual residue levels
of me pesticide that occur m food.
We at CPDA suppwt the discretionary fiexibili^ which H.R. 1627 provides the
EPA Administrator In determining what is a ne^igible risk. We do not believe that
tbt EPA should be bound by a numerical Btraitiacket in defining a ne^igible level
of tiik. Moreover, we suppm those provisions m H.R. 1627 which direct the EPA
Administrator to take into consideration the countervailing benefits of pesticide use.
In so doing, H.R. 1627 permits the EPA Administrator to avoid more hazardous
risks that might otherwise occur in the absence of an established tolerance for a
poiticalar pesticide chemical residue, even if that tolerance poses a greater than
ntdlt^le ruk. For euunple, under H.R. 1627, the EPA Admimstrator could approve
■ level of a pesticide chemical residue in or on a food that poses a ffteater tbui n^-
ligible dietary risk to consumers of the food if: 1) use of uie pesticide protects hu-
mans or the environment from adverse effecte on public health or welfare that
would, directiy or indirectiy, result in greater risk to the public or the environment
than the dietary risk from the pesticide chemical residue; 2) use of the pesticide
inids risks to workers, the public, or the environment that would be expected to
nnilt from the use of another pesticide or pest control method on the same food
' that are considered to tie greater than the risks that result from dietary exposure
to the pesticide chemical residue; or, 3) the availability of the pesticide would enable
domestic growera to maintain the availability of an adequate, whcdesome, and eco-
mnical food supply for consumers, taking into account national and regional effects.
We at CPDA do not believe that a health based tolerance standard which iniores
1 ben^ta evaluation, such as that proposed l^ the Administration in legislation
(HJL 4362) introduced during the 103rd Congress, will satisfactorily solve the
Ddiney problem. The FFDCA can be amended in a simple manner to reinstate the
fladble concept of 'Negligible risk" (a concept which EPA has long supported) when
Mtting permisnble tolerances for pesticides in processed food. A strict nealth based
•tudwd in the absence of any consideration of benefits would likely cause the rev-
«tti«i of tolerances which do not pose a real health threat to the American public
(ad would likely cause a disruption of the nation's food supply.
"PIPBUNB PROVISI(»JS"
CPDA sivpcffts the so-called '^pipe-line" provisions in H.R. 1627, as reported out
tf the House Subcommittee on Department Operations, Nutrition & Foreign Agri-
nUun, irtiich provide that where a tolerance or exemption for a pesticide residue
•n revoked, suspendedj or modified, a food that was legally treated with the pes-
tkide would not be considered unsafo provided that the residue does not exceed the
mvlousl^
BodnnU'
iy authorized tolerance level. EPA would have the authority to declare such
nnlawflil and issue a determination that consumption of the legally treated food
the period of its likely availability in commerce would pose an unreasonable
Ision allows the use of exiating food stocks that were treated with a law-
, this provision would ensure that food producers are not unfairiy penalized
Ibr UM of l^al pesticides that were sulnect to rKulatory action at a subsequent
date. We at CPlM urge membere of this Subcomimttae to support this provision in
ttR.1627. .-i- K
As mentioned previously, CPDA supports those provisions in H.R. 1627 which re-
quire the EPA to establish tolerances on the basis of the percent of food actually
tnated with the pesticide and the actual residue levels of the pesticide that occur
in bod. To this end, CPDA supports those provisions of H.R. 1627 which require
tts Secretary of Agriculture, in consultation with the EPA Administrator and the
Sscrataiy of Health and Human Services, to coordinate the development and imple-
DigilizcdbyGoOgle
Bwntatioii of wamj procaduns to onsiir* that Bdaquate data on fixid conaumptioD
(MtMm of in&utU aiul childiwi am coll«ct«d.
W« at CPDA believe that the collection of this data will be a poaitive etep tanmii
in implementioE the recommendatione contained in the National Academj at
Science* rqMtt, "Peetiddea in the Diets of Infimta and Children,' which call iq»a
EPA to consider the unique aapecta of children's diets and Don-dietaiT Bourcea at
peatidde azpoBure.
In addititm, CPDA U supportive of the directive contained In H.R. 1627 whldi di-
rects the Secretary of Agriculture to collect data of statewide or regional ■igwifiMni*
on tiw lue of pesticides to conbtil pests and itisrssen of m^or crops and cn^ of
dietary eigniBcance. including fruits and vegetaUes.
The collection of adequate pesticide usage data is the lury to arriving at a reaHitic
estimate of dietary exposure to pesticides. In the abeence at such data, scone would
advocate an approach which utuiiee a "Vorae caae" scenario under which asnunp-
taons of maw mum dieUuy opoeuree are made. We at CPDA do not bdleve thit
such an approach avails itself to sensible regulation of pesticides.
INERT8
We at CPDA commend the authors of H.R. 1627 for their enJuaion of "iavt^
from the definition of a pesticide chemical. The comprehensive food safety bill intro-
duced by Representatives Lehman, Blile])r and Rowland during the lOSni Congiun
would have included inerts in the definition of a pesticide chemical. In addition, tbi^
definition was also found in the Administration'B psckase of PIFRA refimn amend —
ments (H.R, 4329), We at CPDA have long been opposed to any efforts which waul9-
enand the definition of a peatidde to include inerta.
If the definition of a peetidde chemical were to be expanded to include inert ingr» —
dients, residue testing would have to include testing for all inert ingredients, le —
gardless of their level of toxid^.
All present residue testing for the current reregisbation of particular crops bd^B.
uses could be invalidated for hundreds of peatiddeB and thousands of uses, vrnnj^
of which are minor uses. Present residue testing studies for key metaboUtes (ncrC^
inerts) costs an average of about $160,000 per crop use per product By adding >LK
inerts, the cost could jump $60,000 to $100,000 for each crop tue for each proouct.
EPA has an extensive inerts program in which the Agency can require tMting oKi
any or all inerts, and has established a priority program to examine inerts of toxx-
cological concern. In essence, EPA has the present authority to require any testify
of inert! it needs. By lumping all inerts together, there is no distinction between
the four categories of inerts, and no emphads placed on inerts of toxicological con-
By driving up the cost of reddue testing on all crop uses, we fiirther jeopardise
minor uses, unnecessarily drive up the price of pestiade products to the Americu
farmer, and place the American pestidde industry at a disadvantage in a ctoDpeti-
tive world marketplace.
We also place a mosdve burden on EPA resources to require review and dediioii
making on all inerts, thus pladng the Agency in an inflexible straitgacket that uD'
necessarily drains money and manpower from already declining resources.
I would like to reiterate CPDA's support of the deddon made by the prindple an-
thors of H.R 1627 to «(dude inerts from the definition of a pestidde chemical.
NATIONAL UNIFORHnY OF TOLERANCES
We at CPDA stron^y support tboseprovisions in H.R. 1627 which establish a u-
tional unifbnn system of tolerances, lliese provisions state, "(N]o SUte or poUticsl
subdivision may establish or enforce any regulatory limit on a qualifying pastiddi
chunicol residue in or on any food if a quailing Federal determinaUon applies to
the presence of such peatidde chemicsl reddue in or on such food, unless suu Stati
regulatory limit is identical to such qualifying Federal determination.'
We cannot expect to promote interstate commerce in agricultural commoditisa, >
the procGBSing, storing or transporting of a food, if we allow states or local pdUtbal
Buboivisions to impose their own tolerances for a pestidde chemical residue. Otho-
wise, we could find ourselves in the unacceptable podtion of allowing states or leal
governments to create barriers to interstate commerce, thus returning us to the pit-
U.S. Constitution days of the Articles of Confederation period in American UstnqF-
Rather than returning to the ei^teenth century, we need to plan for ttie twrat^
first century by odoptftig the natuinal uniformity provisions in H.R. 1G27.
DigiiizcdbyGoOgle
□nZIINATICWUL HABWUnZATION OF BEANDARD6
While CPDA nipporta H JL 1627 Tor Ite proviaiaiu on natioiul uniiarmity of tol«r-
•DMB that would require all states and local governments to establiih tolerancee
Uwtical to those set bjr EPA at the federal level, we liinUari^ endoree H.R 1627
te ita Movisions which encourage the mteniational harmonization of reaidue stand-
arda. Imeeifically, in establishing a tolerance for a peaticide ''*'W"ifii^ reaidue, EPA
would M directed to determine whether a Maximum Residue Levd (HRL) has bera
•ataUiabed bv the Codez Alimentorius ConuniHion (Codex). If a Codex MRL is es-
lahliaheH and EPA chooses not to accept it in setting a tolerance, the Agenc; Admin-
iatiator would be required, as part of the final tolerance dedaicHi, to puSUsh a deter-
urination with supportins data that the Cod^ level is not st^ported by adequate
■nd rdiable data or would not protect the health of U.S. consumers. EPA would also
bs roquiied to show that the eflbct of the tolerance on the aTailablli^ to «
of an adeouate, wholesome and economical food supply doee not outweigh uie nsa
ptaed b; tne pesticide residue.
I re&r your attention to the Congressional Besesrch Service (CRS) section-by-eec-
timi ana^ais and summary of this Ull as considered by the House Subcommittee
on Department Operations, Nutrition and Foreign Agriculture as an amendment in
tiis nature of a subatitute to H.R. 1627 during that panel's May 23, 199B markup.
In its sununan, CRS atates, Thia new aubaeciicni brings our t<derance setting sys-
tan into cranpliance with the spirit of the Uruguay Round Agreement d the Wm'ld
Ttade Organisation (formeiiy known as the General Agreement on TaitSs and
Ikade) and other intonational trade agreements for it tries to avoid unjustified re-
atnints on trade and to make U.S. n^atory dedBions consistent with our inter-
aatiMial trade agreement'
We at CPDA 8UK>ort this provisira on intematiODal harmonization. We believe
Hut it will improve the competitive position of the United States in global agrieul-
total trade mukets by eocouraging uniformity rf pesticide standards acroaa foreign
*" — '--"i. At the aame time, we believe that this provision ensures uiprmniata
'■ *■' "" • the EPA Adm&iiiralar
pesticide use and consumption pettema.
cancelleiVhubpended
While CPDA supports many of the provisions in H.R. 1627 as discussed above,
W would like to see the inclusion of language which would ensure that some nec-
MHiy lmp<nt tderances are not revoked. As currently drafted, H.R. 1627 could be
litopreted to mandate the revocation or suspension of some imp<nt tolerances, if
tkt EPA Administrator, acting under PIPRA, cancels the r^ditruion of a peaticide
dHmical that is labeled for use on a particular food. We at CTOA believe that this
boguage would create a new paradox. It would prevent the eetabliahment of toler^
■ma sir cmnmoditiea whidi are legally treated by our trading partnen, but for
ij 1.- L1--L-J ii — .IB ^-1, loldy due tr "-- '-— "-'
Inwiaie, the current {wadice of setting impi»t tolmnces would no longer be pas-
mk. Ate U.S. food producera and cbemieal manufacturCTa of crop protection chemi-
alf need thia non-saf^ issue clarified to permit trade with NArTA and Gatt part-
on. CPDA believea that daxifying language should be included in H.R 1627 which
■Wild give EPA the discretion to maintain tolerancee, in certain circumstances,
m>n whan a ^eaticida is not rmstered for a particular use in the United States.
8udi modi^nng language would allow the EPA Administrator to maintjin ui im-
Mt tolerance and exempt it from mandatory suspension if : 1) EPA has mode the
■a^ toxicologica] aafety findings necessair to mamtjin a tolerance fbr at least one
fad oae of a particular pesticide in the United States; 2) U.S. tidwancee exist fbr
■Qier uses, but no U.S. r^istration exists that would permit application of the pea-
Ifdde to those raw apicultural products or processed foods; and, 3) the pesticide nas
bam lowflilly an>liM outside the United States to those products or roods, which
fa tarn are imponed into (he United States.
Current cont r o v e rsy over EPA's proposal to revoke tolerances for some uaes of the
*mgk*'V' fidpet provide an example of the need for modifving language. Until the
lata UNO's, Rdpet was registered B>r use on a number of U.S. crops, out the undwly-
log r^istratioas for all uses except avocados sra now suspended. However, folpet
i™^""— to be used on grapes, cranberries and other crops outside the U.S. Any
mocation of folpet tolerancee for tboae crops could have a devastating impact on
Oie wine and other industries. CPDA would like to reconunond that an amendment
DigilizcdbyGoOgle
U^ which UModt FnlCA Sections 4080X3) (revocation of toteranee or exemptiia
fbllowing cancrilatiim of ueociated r^istrmtioii} and 408 (j) (3) (A) (nqpeniion if
tolerance or exemption followins wiipenriop of aaeodated regiittalions) to at^nUt
that revocation w au^Mnsion « a tcderanc* will not be ponued pnmded that S»
peatldde diemical ia lawAilW uaed outaide the United Statee on anotfaer lav Mil-
CONCLUSKW
(FFDCA), andreapactftilly UTgepaaaagaofTiUelVofRIL 1627.
The National Aaaodation of State Departments of Anieulture (NASDA) ia ttu
nonprofit aaaoeiation of public ofBdala representiiig the Conuniasionen, SeeretuiM
and Diractora rf Agriculture in the fifty statea and the tanitoriee of Amenoo
Samoa, Guam, Puerto Rico, and the Virgin Islands. As the chirf state a^icultofa
officials, NASDA's members are keenly aware of the importance of balancing igri-
cultural production and natural reaource amaervation on their state's and tae na-
tion's economy.
In most caaea, under a cooperative agreement with the Environmental Protectka
Agency (EPA), the state deputments M agriculture aerve as the lead state peitldilB
ragulabny agency. 'HterefbFe, NASDA brings a unique pe r spective on peaticids ngn-
lations and the reauthorisation rf the Federal Inaecticide, Fungicide, w
Rodenticide Act (PIFRA). NASDA manbers rept«a«it the fivnttma peaticida Tegs-
lators who must balance human health and environmental protection with fiumen
needs, and face the state and local anzie^ over pestidde use and regulation.
BACKOROUND
Under FIFRA, EPA is responsible for regiatetin^ pesticides using Tisk-bencfit
analysis to ensure that pesticide use will not result m unreasonable uverae efEecO
on health or the environment EPA registen a pesticide only if it detennines that
it will not cause ai^ ^mreasonable risK to humans or the environment, taking iata
account the economic, social, and environmental costs and benefits at the use a
[the] pesticide.' Basically, r^istrations are licenaea fbr specific peaticide uses thai
state the terms, conditions and cautiona of these uses.
To regiater a pesticide, EPA requires the manufacturer to provide health and en-
cant a few months to several years to gttaac the necessary data because of the
C
application. This process takes an average of two yean if ell necessary data has
been provided, but much longor if data is incomplete and additional data is needed.
Separate l^slation guides the setting of tcderences for residues of pesticides reg-
istered underTIFRA. The Federal Foo^ Dnig, and Ownetic Act (FFIX^ requires
EPA to establish tolerances— the maTiTniim liinitB of pesticide residues alloimd in
or on raw agricultural commodities, processed foods, or animal feeds. Establishing
a tolerance is a prerequisite to granting r^jstration for food-use pesticides used in
the United States.
In order to establish a tolerance, EPA must determine whether tolerance leveli
proposed by pesticide registranta wiU present a health risk to the consumsr. Rw-
istnnts are required to submit tozicologv and rendue data in th^ tcderance peti-
tions (applications) to assess possible hudth and environmental risks, to identify Uu
nature and amount of residue that could occur with proper peaticide use, and to
present analvtical meOiods that the Food and Drug Adminietration (FDA) can use
to test the food fbr residues of the pesticides. EPA scisntists (reviewers) uee thii
data to assess the possible health rlau of a pesticide'a use on fbod and to deteimini
whether proposed tolerance levels would protect the public health. FDA enforces the
EPA tolerances for both domestic and Imported produce.
3I1IZCCI by ^jWCI'
igle
CONORESaiONAL DEBATE
American conaumers can be confident that the U.S. food supply it safe from un-
•uonable risks presented hy pesticide reoidueB. The food products available to U.S.
nDBumers are safe, abundant and economical. NASDA does believe, however, tluit
mmiovements in our pesticide laws are needed primarily due to advances in sd-
m£e technologicBl capabilitiea.
At the national association of the state lead peatidde regulatoi? agendee. NASDA
bditvea that H.R 1627. the Food Quality Protection Act of 1996, will Improve fed-
<nl regulation of pesticide use ana eataUish national umform tolerances fbr resi-
Am in food baaed upon a "nadinble risk' standard, as recommoided by the Na-
liaoal Academy of Saeoces (NASj. Adoption of this IsEialation will allow the U.S.
I* continue to produce (he safest, most economical, and most abundant food supi
in tlw world. NASDA strongly supports passage of H.R. 1627 and eneourasss ttw
Hnua Commerce Committee to move quickly to favorably repwt the bill. H.R. 1627
^ most balanced and responsible piece of Inpslation pending before Congress.
The current debate over pestidde regjolation reform bolls down to a simple conflict
Ntween sound sdeoM a . -
HIOID NBOUOmLE BISK OTANDARD
tbt FPDCA should be amended to eliminate the outdated "zero risk" Delane/
)f evoTving scientific standards and to consider all relevant safety and
uKsure mtormation. H.R. 1627 aUows EPA to employ its expert judgment
luuundered by a numerical strailgackeL
LIMITATION OF BENEFITS
HJt. 1627 would make dear that EPA may establish a tolerance for a pestidde
nsldue posing greater than a negligible risk if EPA determines that there are coun-
tvnjUng ben^ts. EPA would be directed to take into account health, nutritional
UM consumer benefits, mduding the unpact of the loss or a pesticide on the avail-
^^Hty of an adequate, wholesome and economical food supply. EPA would be pre-
duded from considering any impact on pestidde manuudurers or disbributors.
flASDA believes this language must be induded in any pestidde reform legislation.
CANCELLATION AND SUSPENSION
NASDA bdievas that statutory changes are necessaiy to permit EPA to remove
■iUardous pesticides frran the market with reasonable speed. H.R. 1627 would
oinuuata the a^iudieatra^ hearing process for cancellation procedures, and suspen-
Oon actions wmild be decoupled &om cancellation procwlures. Accordin^y, we
"rondj' suppral these provisions to streamline and accelerate the suspension and
ViceUation procedures.
Amendment Needed to HH. 1627^NASDA beUevea a prouiaion should be
inducfed whiA woiUd provide an expedited process to retrieve chemicaia
from the end-uaer farmer) tehUA have been camxled and euepended.
TOLEBANCE UNIFORHTTy AND FEDERAL PREEMPTION
A tolerance uniformibr provisioa is indispensable to preserve EPA's leadership in
■cstidde r^ulation ana to avoid consumer confiision and unreasonable burdens on
nterstate commerce caused by special state tolerance requirements. NASDA strong-
y si^poTts the uniformity provisions of H.R. 1627.
Pesticide use r^(ulati«u are best enacted and coordinat«d at the state level at
u^tsr. In this way, conflicting and overiappl regulations roa^ be avoided, and
nater access to — ■T"t'f'' expertise and inoi is available. With greater dtizen
\pat at the state level, action taken will 1 ; all residents of the state rather
lan one isolated town or village. During co oS H JL 1627, the House Ag-
DigilizcdbyGoOgle
126
rieultun Subcommittee on Doportmant Operationa, Nubritimi, and FotoigD Agri-
cultui* includtid pronuona to Moride aenaible, umfimn faderal/aUto raguIatiMi of
pavtiddes throu^ languay ouiiiig br bderal/rtate pnemptioa of local itgulitiDni
while aUowing local iiqiut into the fad«nl/atat« ngaMoiy proceaa. NASDA tOm^j
aupporta theae pnviaiona.
inor uae proriaiona contained in Hit. 1627 uui
. . , reaentativeB (Kike) deUGana and House Agii-
culture C<munittee Chaiiman Pat Roberta.
The proviaiixis in theae btlla will go a long way toward comcting the invblein at-
ated inadvertently bjr the 1SS8 amendmenta to FIFRA vriiidi have lea to the Idh
of neceaaaiy minor uae crop protection chemicala. While the minor use iaauc ii an
economic one and not a bod safety issue, it is extranety important to reeolve tlu
iaaue.
If tkt eomprthmmve biU, HJL 1627, eatutot be paamd hy tht I04th Cm-
grt»», it ia txtremely important to pam H.R. 1352 at a itand alone bilL
PDA BNFORCBMBNT AUmOBnY
fDA already poeaeaaea ample enforcement power with reqwct to food vitdaliaiii,
indudins seixure, injunction and broad criminal penalt? autboritr. NASDA dots art
believe tnere is a demonatratad need for FDA to have the additiona] mfbrcemrat
authority, auch aa recall, embargo and dvil penal^ authori^ for peaticide tolerance
the due proceaa rights of r^ulated parties. There ia also no reason &x FUA. to have
ditferent enforcement authiui^ for pestadde tolerance violations than for other food
infractions.
FEDERAL AOBNCY COORDINAIKSI
Consultation and coordination within the federal government on food and ms-
tidde reeulationa need improvement. Currentlv, consultation among EPA, U.S. De-
partment of Agriculture (USDA), and FDA prunaiily occurs in tiM finm of written
cranmenta dunng cancellation of a pestidde's n^istration. <^ven the linkage among
pestidde uses, agricultural production and food safoty, the three regulatmy atgenciea
involved must consult more ^edivelv and regulariy. Moreover, communication and
coordination among the three fedo-al regulatory ageodes and the state regulatin?
agencies needs improvonent.
SECnON 18S
In order to facilitate timely and equitable approval of section 18 emergency ex-
emptions, NASDA recommends a consistent system for issuing section 18a biefore
section 3 registration is complete. States requestinE a section 18 for using the same
product on the same commodity are currently dealt with individually resulting in
the oroduct being available in some stetes and not in others where uie same pest
problem exists,
NASDA alao believes EPA's reauirement for aquatic residue and avian incident
monitoring for section 18 approvals should be rescinded. This burdensome require-
ment seems to contradict an October 29, 1992 decision on reoistration and ra«g-
ia&ation requirements made by EPA based on the recommenoation of the Bcolo^-
cal. Fate and Effecte Taak Force. In the October 29 memorandum, then-adminis-
trator Linda Fisher steted: "More specifically, OI^ will no lower require avian and
aquatic field testing, except in unusual orcumstances. Rather decisions will be
based on lab testing, inddent data and otlm information which can easily be col-
lected to enable the prcwram to better characterize potential riak." While the above
poU^ was spedfieally designed fbr r^iatration and ret^istration, it appears to be
inconsistent and unnaceasanr to require sudi fi^ data on a section 18 exemption
Digilizcd by LjOWQ IC
127
Anundtrunt Needed to H.R. lS27—La7iguage should be included in H.R.
1627 which requires EPA to make the section 18 tyatem eontistent. A further
provision it needed to rescind the aquatic retidzie and avian indderU mon-
Uorin^ for section 18 approvals. An amendment should also ensure that crop
grouping is recogtuzea and EPA handle crops in the same family equally
when approving a section 18.
CERnnCATION * TRAININO
oQter FIFRA requirement. The current match for certification and training fUnds
ii 60/50 and the other FIFRA match requirements are 8G/15. NASDA recommends
that the certification and training match be S&'IS and phased-in over a three year
period. Such a change would not increase the budset roquirementa or expaaure to
the federal government. It would simply reduce the ninding mandate on statea.
Amendment Needed to H.R. 1627 — A provision should be included in H.R.
1627 which modifiet the certification and training matching Jitnd r^uire-
ment. The provision should change the match to 60140 the first year, 701
30 the second year, and 86/ IS the third and future years.
CONCLUSION
Allow NASDA to concluded by once again streasins the importance of paaaing le^-
uletioD to reform pesticide regulations in the 104tE Congress. NASDA believes tt
M. Hr. Chairman, it ia imperative that this Congress reform peatieide regulation
lliank you for your connderation of NASDA'a views as stat« regulators o" *^
important issue.
DigilizcdbyGoOgle
DiBiiizcdbjGoogle
FOOD QUAUTY PEOTECTION ACT OF 1996
thursday, june 29. 19ss
House of Representatives,
CoMMirrEE ON Commerce,
Subcommittee on Health and Environment,
Washington, DC.
The subcommittee met, pursuant to notice, at 1:54 p.m., in room
2322 Raybum House Office Building, Hon. Michael Bilirakis (chair-
man), presiding.
Members present: Representatives Bilirakis, Burr, Bilbray,
Whitfield, Ganske, Norwood, Cobum, Waxman, Brown, Stupak,
and Pallone.
StafT present: Mary M. McGrane, majority counsel; Howard
Cohen, majority counsel; Melody Hamed, majority counsel; Eric
Bei^r, professional staff member, and Kay Holcombe, minority
professional staff member.
Mr. Bilirakis. The hearing will come to order.
The United States enjoys the world's safest, most abundant and
affordable food supply. Maintaining the wholesomeneas, the variety
and the low cost of our Nation's foods is critical.
For a number of years, scientists and the Environmental Protec-
! tion Agency and those involved with growing and processing our
i Nation's food supply have agreed that the Delaney Clause is obso-
I 'ete. It was based on the scientific knowledge and techniques of the
1950's. The Delaney Clause greatly exaggerates the degree of risk
! Uid ignores any benefits to society from the use of safe crop protec-
tion tools. Congress and this administration need new legislation
that will give EPA the flexibility that it needs to regulate pesticide
Use, as well as ensuring that strong standards will remain in place.
Particularly standards for the health of infants and children.
The Bliley-Towns Bill, H.R. 1627, replaces the Delaney Clause
With a negligible risk standard which moves EPA away from the
ligid zero risk standard. It also contains a number of provisions
^Kat would ensure sufficient consideration for the safety of infants
^d children. These would fulfill many of the recommendations of
\he National Academy of Science's report, without unduly restrict-
^g EPA's scientific judgment. Some of the provisions of H.R. 1627
that implement the NAS recommendations indude collection of
^ta on food consumption patterns of infants and children, im-
proved surveillance of pesticide residues, increased sampling of
foods most likely consumed by children and toxicity testing proce-
dures and methods of risk assessment that take into account the
unique characteristics of infants and children.
(129)
DigilizcdbyGoOgle
180
"niese provisions would build upon the current EPA methods d
protecting infants find children which calculate dietary risk foi
those under the age of 6.
Mr. Wazman's bill would impose a separate risk standard— rea-
sonably anticipated to cause cancer and other effects In the case of
children. Unlike the negligible risk standard of H.R. 1627, or the
current safety standard under Section 408 of the Food, Drug and
Cosmetic Act, Mr. Waxman's bill would again impose a zero risk
standard.
Indeed, the "reasonably anticipated to cause" standard has been
interpreted by EPA in a number of other environmental statutes to
foreclose the consideration of exposure or dose. Therefore, this
standard would pose the same proolems as the Delaney Clause b;
Erecludlng EPA from establishing pesticide tolerances under a n%-
gible risk standard.
H.R. 1627 already provides EPA with adequate authority to ex-
amine all dietary risks associated with pesticide residues, includins
breast cancer and reproductive effects and to consider the spedal
sensitivity of all mjgor consumer groups, including women. Sepa-
rate standards for particuleir disorders, I think, are unnecessaiy.
I would recognize the ranking minority member, Mr. Wazman,
for his opening statement.
Mr. Waxman. Th£tnk you very much, Mr. Chairman, for rec(^;nit
ing me, for holding this hearing. I want to apologize to you and to
all the participants of this hearing for the delay. Not only did we
have a vote on but I was tied up in another meeting dealing with
a hospital problem in my district.
Mr. BILIRAKIS. I thought you might have stopped to take a little
nap after last night.
Mr. Waxman. I wish. I wish. I am looking forward to next week.
I have serious concerns about H.R. 1627. It would repeal basic
health standards, create new bureaucratic hurdles for Federal
agencies, subordinate hesilth concerns to economic considerations
and dramatically diminish the role the Federal Government has in
safeguarding our Nation's citizens from pesticide risks. If we as-
sume this bill will pass this subcommittee and the House, the Fed-
eral Government simply will no longer be able to help protect con-
sumers from being exposed to a number of pesticides that are
known and probable human carcinogens. I obviously strongly dis-
agree with tnat result but if it happens, H.R. 1627 should, at the
very least, give consumers the option and ability to protect them-
selves.
Individual citizens must have the tools to fend for their families
if the Federal Government abandons its traditional role of protect-
ing the public health. That is why the right-to-know provisions in
H.R. 1771 are so important. By providing a short, common-sense
warning label, we empower consumers who are concerned about
unnecessary exposures to dangerous pesticides to protect them-
selves. H.R. 1771 also recognizes that, at a minimum, we must also
adopt a speci£il standard to protect kids from dangerous pesticides.
A tolerance should not be issued if EPA reasonably anticipates that
a particular pesticide will hurt children.
To ensure that sound science is used in making these determina-
tions, the bill directs EPA to follow the recommendations of the
:,zcdb^k>OgIe
131
National Academy of Sciences report on pesticides and chil-
The same common sense test must be applied to pesticides
ose a special risk of breast cancer or reproductive harm for
1. Without this provision, the BlUey-Roberts bill would expose
is of women to a preventable and reckless danger.
Chairman, we are not asking for a zero risk standard. We
mply saying that we don't feel that the Bliley-Roberta bill is
h protection because it would allow the use of pesticides that
» residue in food that offer a special risk to children, and they
How the use of pesticides that offer special risk to women of
cancer. If we are going to allow that, we ought to recognize
iblic's right to know. If it is going to be a risk, the public
to know about it and be able to decide for themselves if they
X) take that risk.
reason the bill, the fundamental bill, the basic bill, the Bliley
so troublesome is it doesn't protect against health risks. It
«a]th risks are one thing but economic considerations are an-
Risks will be permitted if the economic considerations are
outweigh the nealth risks. That is why we have s£iid, if you
ing to use that standard, use it, but if there is a speciiil prob-
>r children, we ought to take precautions there. If there is a
1 problem to women because of breast cancer, take special
itions there. And if it is a risk overall, at least let the public
about it.
will be offering our bill as an amendment. This hearing, we
will flesh out the issues and Eillow witnesses to testify who
:hese specifil concerns. I certainly want to work with you and
her members of the committee to get a responsible piece of
tion through. We have been trying to do that for a number
rs now. But I do not feel that the Bliley-Roberts bill is a re-
ble one. I think it puts the public at great risk unnecessarily.
nk you for calling this hearing.
BiLIRAKIS. And I thank you, sir.
Cobum is recognized for an opening statement.
COBURN. Mr. Chairman, I don't have an opening statement.
BiLiBAKis. I thank the gentleman. Mr. Stupak.
Stupak. Mr. Chairman, thank you for c^ling this hearing.
d like to yield my time to my colleague, Sherrod Brown, who
> be in a markup here, so I'd like to pass and yield to him.
BiLIRAKIS. I have no problem with that
Waxman. Mr. Chairman, would you just allow me to say I
to run down to another hearing, just to make an opening
lent. I'll be right back.
BiLIRAKIS. Sure.
Brown. Mr. Chsiirman, thank you, and Mr. Stupak. I just
d to enter my statement in the record. I have a markup in
ational Affairs, and I'll yield my time back to Mr. Stupak,
}uld like to enter my statement.
BiLIRAKIS. We're playing games this morning, I guess, but
ve to do that to stay awake.
Stupak. I have nothing further, Mr. Chairman.
BiLIRAKIS. Nothing further? Doctor — I don't think I have to
n, do I, that we have been up all night voting? I think if you
ok at us, you can see that.
DigilizcdbyGoOgle
133
Dr. Norwood.
Mr. Norwood. Mr. Chairman, I ask unanimous consent to enter
my remarks for the record, olease.
Mr. BlURAKIS. Without objection, all members' remarks will be
made a part of the record.
[The prepared statement of Hon. Sherrod Brown follows:]
Thank you, Mr. Chunimn. I am plMMd to tay that when 1 go to the cupernurkn
to ihop for mvMlf and my two dau^ten, I can buy applea, or aoup, or anr (f the P
thouaanda of foods cuirently protected by our food aafefy lawa, all through uu mv. |
No one can uvue that Americana have the M&et, moet abundant, and affindiblt I
food aupply in the worid. But there ia room for improvement. H
To nuuntaln the quali^, quanti^, and price of our food iupplv, it ia neccMuy S
to recooaider the wav we weigh the relative riaka and benefita ot uaing peitiddM. f
At the aame time, I Dolieve we must rely on a tingle, health-baatd ttanaant vfaen I
determining tolerance level* of peatiddea on all fooda. We oon be flenble without |
compromiaing our oUigation to protect public health and Mfo^- |
While acience baa become too simhiaticated to reasonably adhere to the 'uro-iiik' _
standard of the Delatwy Clause, 1 believe we can develop a standard for all CDodi f
that promotea flexibihtv, while at the same time maintaining the integrity of our |
food supply. A standara like this will Berve as a benchmaA mr EPA oa thi^ weigb
the balance of benefit* in determining tolerance*. Smart government allow* HmU
to consider the balance of influence of all things, and I bdieve food safW? ihodd
permit the wisdom of this analyal*.
However, aa the committee continues this discuadon considering the incluiloii of
scientific data in the determination of pesticide tolerance levela, I want to mib
sure that our most vulnerable coneumer* are afforded special protections. Inisnt'i
and children's diets include concentration* of food* that are not presoit in adult
diets. This fsct, together with the knowledge that growins bodies are vulnoable to
the chemicals found in pesticide*, demands our attentfoa Con*l*tent with the report
issued by the National Academv of Sdence, I urge the committee to ensure adequttc
protections for infknts and chiloren.
Ai^ way you look at it, a sale, economical and abundant food supply ia in tht
best interest of eveiyone. A safo food supplv mean* we can eat tooiatoes, and wittr
melon and strawberries this summer until our hearth content An econoimical boi <
supply meana eueryont can aflbrd to eat these foods. And finally, an abundant bod i
supply mean* that we will never go vrithout. All of these thing* amount to conmnMr <
protection* that I believe ore imperativB to maintain consumer confidence.
With the proper revisions to today's food safety laws, we can improve on the v«lu«
of our food aupply and preserve connuner confidence. A quality food supply gim
us children who can leam in school, it gives us a productive won force and it 0vw
us a healthy public. I appreciate the work we are doing here today and look fiarwud
to hearing mnn our witnesse*.
Mr. BlLlRAKls. Doctoiv-you have no other opening statement, Dr-
Norwood?
Mr. NOEWOOD. No, sir.
Mr. BlLiRAKis. Dr. Ganske?
Mr. Ganske. Thank you, Mr. Chairman. Ill be brief. I have an
interest in the testimony, some of the testimony — all of the testJ-
mony we are going to hear today.
My mother had breast cancer when she was 23. I have — con-
sequently all of my aiaters have an increased risk for breast cancer
and over the course of my medical practice both in general surgei?
and plastic surgery I took care of a large number of ladies who nad
breast cancer, and all of us who have children and have had the
opportunity of taking care of children are concerned about these is-
sues and so I look forward very much to some of the testimony.
Thankyou.
Mr. Bujrakis. I thank the gentleman. His time has expired.
mzcd^AViogle
I would ask the panelists to come forward as I call your name.
Ms. Nanc? Chuda of Los Angeles, California; Dr. Philip
Landrigan, nrofessor and Chair, Department of Community Medi-
cine, Mount Sinai Medical Center; Dr. Mary WolfT, Mount Sinai
Medical Center; Mr. Robert Eichler, from Portage, Michigan; Dr. J.
Routt Reigart representing the American Academy of Pediatrics;
Mr. Edward Hopkins, Environmental Policy Director with the Citi-
zens Action here in Washington; and Ms. Caroline Smith-DeWaal,
Director, Food Safety Pro-am, Center for Science in the Public In-
terest again here in Washmgton.
All of your prepared statements of course, as you know, are part
of the record. I would ask you to keep your oral statements within
the 5-minute rule, and possibly during the round of questioning if
there are other points you may wish to make you'll have an oppor-
tunity to do BO at that time.
Let's start out with Ms. Chuda.
gTAT EMENT S OF NANCY GOULD CHUDA. ON BEHALF OF
COLETTE CHUDA ENVIRONMENTAL FUND AND CHnJ>REN*S
HEALTH ENVraONMENTAL COALITION; PHILIP J.
LANDRIGAN. CHAIRMAN. DEPARTMENT OF COMMUNITY
MEDICINE. MOUNT SINAI MEDICAL CENTER; BOB EICHLER.
PORTAGE, MI; J. ROUTF REIGART. ON BEHALF OF AMERICAN
ACADEMY OF PEDIATRICS; MARY S. WOLFF. MOUNT SINAI
SCHOOL OF MEDICINE; EDWARD HOPKINS. ENVIRON-
MENTAL POUCY DIRECTOR. CITIZENS ACTION; AND CARO-
LINE SHITH-DeWAAL, DIRECTOR, FOOD SAFETY PROGRAM.
CENTER FOR SCIENCE IN THE PUBLIC INTEREST
Ms. Chuda. Good afternoon, Mr. Chairman, and members of the
lubcommittee. I am Nancy Gould Chuda, Chair of the Colette
Chuda Environmental Fund and Executive Director of the Chil-
dren's Health Environmental Coalition. M^ husband, James, is the
Co-Chair, and I appreciate this opportunity you have affonied us
today.
I am here to testify on behalf of children, too young, too vulner-
able to protect themselves from the dfiily onslaught of chemical tox-
ins to which they are being exposed.
H.R. 1627 ignores what the NAS told us 2 years ago in its report.
This report found that the current regulatory system fails to give
special consideration to the unique vulnerabili^es of infants and
odldren ref^irding pesticide exposures. It also fails to acknowledge
the cumulative and synergistic impacts of multiple exposures.
We know that there are 750 million pounds of 20,000 different
I»esticidal potions used in America annually and currently regula-
tions allow for 40 pesticides in carrots, 67 in strawberries, and 82
in grapes. These are the tjrpical foods that children consume in
great quantities. H.R. 1627 enshrines into law that if a pesticide
residue poses a significant risk to the public including children the
residue is still allowed if it is said to have a sufficient oeneflt.
There is no benefit to a government that puts its children at risk.
We lost the love and light of our lives when our only child, Colette,
died of Wilm's Tumor, a rare, nongenetic form of cancer in April
1991. She was 5 years old. There are no words of comfort that can
DigilizcdbyGoOgle
1S4
be offered, no consolation for the lou ai opportunity shared iriien '
a child dies. '■■
I believed intuitively that something in the environment had
interfaced with her gestational development and after consultiiig I
an expert on Wlm's Tumor, I learned that it was possible that ,
something that I had ingested or was exposed to during my png- j
nancy could have caused ner cancer to develop.
In March 1995 a study was published in the American Journal
of Epidemiology, Tarental E^qKtsure to Pesticides and Risks ti
Wilm's Tumor. It stated that environmental exposures may con-
tribute to the development of Wilm's Tumor. The study reveus the
highest odds ratio to be among cases diagnosed after 48 months cf
age for maternal exposure. Colette was exaetiy 48 months of agt
when she was diagnosed.
This was our daughter. She is featured on the cover of thii
month's '^, the Environmental Magazine." and it is because of her
and the countless other children whose lives are being lost to can-
cer that we must make legislative changes now.
When children are stricken with cancer, you fight for their liveB.
Your heart grows cold at the thought that they might die. The bat-
tle you wage is equal to all the world wars that have ever been
fought, to see children clinging to their mothers and fathers for life,
to gaze into their eyes and see hope dwindling, to feel their confb-
sion when words can no longer be uttered or understood, to watch
trust, the very bond that glues them to our hips, slowly slipa
away — it is at these moments that you wish that you had never
l>een bom, never to bear witness to such cruelty. We will never fo^
get her bravery. She taught us not to be afraid to die and it is this
flame that bums deep in our hearts that brinj^ us here today to
spare y^ou and your diildren and your grandchUdr^i this intoler-
aole pain.
I am convinced that Colette's death was due to a pesticide expo-
sure and had I known that about the carcinogens she or I were ex-
posed to, I would have had a choice. I could have found safer alter
natives.
Two davs before she died she looked at us and said, "Monunie,
why did this have to happen to me?" I cannot answer her question
and to this day Jim and I have only her mission in our hearts and
the knowledge that we, the people, will find the answer.
Since her passing 4 years ago not a day goes by when I dont
think about what could have caused her cancer ana it is for these
reasons that we strongly encourage you to support H.R. 1771, The
Pesticide Safety and Right to Know Act of 1995.
I praise Congressman Waxman for his continuous efforts and de-
termination to protect our Nation's children. Let us have the choice
and the right to know what is in our food and the products we
consume, ^t us begin with a new trust, one that restores hope in
the Government, which currently does not provide for our children
with the safeguELfds they deserve.
I speak for countless parente concerned about these issues who
feel helpless and frustrated in not being given the right to know
and the freedom to choose.
If we value our children as I know we all do, we must protect
them and we must provide for their safety.
zcd^^OOgle
1S6
Can we take the risk of being wrong?
I ui^ ^ou to err on the side of caution and I thank you for this
ipportunity to share with you today, and 111 be pleased to answer
my of your questions.
rrhe prepued statement of Nancy Gould Chuda follows:]
Pbepab£d Stateiient of Nancy Gould Chuda, Chair, Colette Chuda Environ-
HENTAL Fund, Executive Director, Children's Hbalth Bnvironiiiental Coali-
tion
Momiiig, Mr. ^
jould Chudm, Cbair tt The Colette Chuda Environmental Fund and Exeeutim Di-
rector of the Cbildren'a HwUth Environmental CoaUtion (VCHEC). My husband
lunea, eo-chair of The Coletto Chuda Environmental Fund, and I appreciate this
ippprtuni^ you have provid«d ua.
nu Colette Chuda Environmental Fund and ita project. The Children's Health
Environmental Coalition {vCHEC) are non-profit environmental organisations
' ' ' 'n June 1991. We firvt eMablished the fbnd to reeearch liie eauaee of chil-
— • ■ (VCJ — ~-
relation to the environment We then created (VCHEC). This na-
' res parents a unified voice and an oppor-
ite to the environmental health and safe-
titnud bipartisan grasaroots organisation Dves parents a unified voice and an oppor-
*■-""* ~— IS their cooeemau they rMst' " "■ ' '-' •---'" -■ — '-
I am here to teatiiy on b^balf of our oTganization and for thoae who are too jroung
■ad vulnerable to protect themselves from the daily onslau^t of chemical toxins to
iriiich they are being e^Msed.
nie pesticide laws that you are considering eoscting totaUy diarmnrd the spedal
Daeds of children. H.R. 1627, The Food Quali^ Protection Act of 1996, ignores what
Hie National Academv of Sciences (NAS) told us two years aeo, in its report, Pei-
tiddf in tht DitU of InfanU and Young Childrtn (1993). This report found that
ptstidde toleraocss are not based primarily on health considerations, and that the
Eunent regulatory system fails to give special consideration to the unique
ndnorabilitiee of In&nts and children as they relate to pestiade exposures.
H.R. 1627 fails to acknowledge the cumulative and synergistic impact of multiple
opoBures. This bill does not comply with the NAS findings. In Csct, it undercut*
intective provisions thus weakening our pesticide l&ws. If H.R. 1627 is left
loamended. Dr. Philip Landrigan, who directed this study, has concluded that "Ve
vill 1^ default continue to conduct a massive fliiiifl toxicological trial and our chil-
Iren and their children are the experimental animals."
According to the Academy, 'children should be able to eat a healthful diet contain-
-Dg legal residues without encroaching on safety margins.'' Any legislation that is
?used should require an explicit finding that exposure to legal linuta is safe for in-
lants and children. This Ull does not allow coosiaerations of multiple pesticides, and
ESaib to consider the threats possd by so-called "inert" inpedients.
Children are unique. They consume large amounts of fruit and vegetables, signifi-
eantiy more pnqMntionany than adults, in relation to their size. These foods are all
Bommm vehicles for pesticide exposure. Hie average one year old drinks 21 times
nun apple juice, 11 tunes more grape juice and 2.6 times more water than the am-
ttge adult. Childiwi also eat as muui as seven times more grapes, strawbenies, ba-
Qsnss, apples, pears, canots and broccoU. What we are finding out about children
(onning and far more vulnerable to ue toxic residue tiiey ingest ii
Quu- adult counteipaits.
We know that 7W million pounds of some 20,000 different pestiddal potions are
poured over the American landscape annually and currant regulations legally allow
w 40 pesticides in canots, 67 in stra wherries and 82 in svpes.
These are the ^rpical fbods children consume. H.R. 1^27 enahrines into law that
*v«Q if a pesticide residue poses a significant risk to the public, children not with-
■ttnding, the residue is allowed if it is said to have "sufficient benefits."
nwre is no benefit to a nation that allows its most vuhierable members of society
to be at risk.
And at risk they are. Every day, the NAS study reported, about 1.3 percent of
tlu nation's two-yeaindds, or about 60,000 children, receive a dose of five pesticides
in excess of the EPA's acceptable limits. A related study by the Environmental
Wvkuig Group (EWG), Peatiddea in Childrtn'a Food (1993), documented for the
Snt time the prevalmee of multiple residues in single foods. It reported that it is
Hot unccmimon fbr chlldnn to eat siii(de piece of fruits or vegetables with 5 or more
pettiddes on them. The study revealed the severity end imbuance of pesticide expo-
DigilizcdbyGoOgle
— , -, j»6, it OL . ,
bMT a dispTDportionatal; bMvy burden from pMUdde* In tOoi and watsr. Yet, 0»
Environmental Protection A^ancf haa never eat a tolerance for a peatkide in find
ipedficaUy to protect inCuts ana diildren.
In another atudr releaaed br BWG in Februai7. FoHtiddtn Fruit: lUMgai FuUddu
in the U.S. Food Supply (1995), it waa reported that Americana eat 3 Ullion pouadi
of produce contaminated with Ulanl peatiddaa each mar. Over 90 percent of Hit
violationa noted involve two kinda of illesal peeticulea; n»4d««ner violatuni,
where the peatidde ia found on a crop even thou^ the allowahle level for the bh-
tidde on that crop ia sero; and over-tolerance violatian, where the amount a tlie
peatidde found exceeda the legal limit for that crop.
As eonsumera we enter the marketplace eveiTOay truating that what we bu; tod
ahare with our umiliea and frienda la eafe. We expect that our hard-earned tax do(-
lara are providing for protectiona that will aafeguard ua and eapeeially our diildnn.
A> dtinna of thu country we deaerve that right Aa lawmakers, vou muat wmUt
us with an opportuni^ to make the choices that will support the nealUi and uktj
of our funiliea.
I wouldnot be sitting hera today if it weren't by the grace of God and the tngtdr
my husband and I were meant to face. There are no words of comfort that can M
offered, no consolation for the loss of opportunity shared, when a child diea.
We lost the love and the light from our lives in April, 1991, «4ien our only diiU,
Collette, died of Wilm's Tumor, a rare non-^netic form of cancer uod one d da
moat common abdominal diildhood malignanaea. S9ie was Gve years old.
As her mother, I believed intuitively that aconething in the envinmment hid
interfaced with her gestational development Later I learned, after consulting an <■■
pert on Wilm's tumor, that it waa pceaible that aomething I ingested or waa expostd
to in my environment during my time of pr^noncy could nave triraered t£a (b-
sbuct mission that cauaed her cancer to later devslap. And in Marcn 199S, I it-
ceived a newly released study that supports mv belief about my pesticide esmosun
and the development of Wilms' Tumor in my daughtw. The study: ParentafBtp^
sure to Peslidda and Riak of WUnu' Tumor m BrazU (1995), published in the Anw-
ican Journal of Epidemiolosr, states that environmental exposures may contribnta
to the development of Wlm? tumor. The most important finding related to na ago-
sure and Colette's cancer concerns the interactions between parental pesticide vm
at exactly 48 months <.. _„-.
Additionally, the study indicated that "the effects of pesticides could be medisMd
by mutations in germ cells, by exposure of the fetus in ut«ro, or b^ exposure »Sxi
birth from residues present in breast mi lit , in foods, in the home, or in the surrounil-
ing environment"
Another study released last fall, Handle With Cart: ChUdren and ETwironmentd
Canrinogena (1994) reviews what is known about childhood exposures to cardnagu*
and examined information on nearly 400 cancer-causing chemicals, some of wnidi
are present in our homes and schools. This report, by The Nat "' " " " "*
fense Council, reveals that "the overall inddence of duldhood eai
' cent between 1973 and 1990. Brain/nervous system
iphocytic leukemia increased 32.6 and "" '
rs.' Cancer, the council reports, is now ti
__ . n late infancy through early adulthood.
Additional findings determined that certain peatiddes ii . .
anticipated to cause manv health problems associated with children: infertili^, i*-
productive, developmental, endocrine, neurobehavioral, respiratory and immune i^
tem function, and cancer.
Ilie study emphasized that children are not simply smsll adulta. Thejp are gn*-
ing, and developng and are thus more vulnerable to exposure from environntenw
toxins that indude certain peatiddes in food due to their physiology and their bt-
havior. Sdentific data which is derived entirely from adults or from testing on adnu
animsla is not an accurate way to predict how a child will react to chemical coO'
pounda."
More evidence related to pestiddes and the development of childhood cancer m
reported in Parental Occupational Exposures and Risk of Childhood (^noer: A Rt
view (1991), a study published in the American Journal of Industrial Medicine. '^'-
report notes there is a "strone correlation and association between parent occupt-
tional exposures to chemicals found in peatiddes and the risk in our nation of chiU-
hood malignancy ."
DigilizcdbyGoOgle
"Hiis growmg body of tdentific evidence makee it clearer than aver before in our
ution's history that children are being expoaed to a hoat of life-threatening tone
dkemicala, many of which are ubiquitoua in their anvironmant. A taxicologiat at the
National Inatitute of Environmental Health Service recently underacorod the grave
nature of the problem we fkce. 'It ia estimated that a complete health hazard aa-
iiinnent is available for leaa than 1 pertent of commerdal chemicals and Kaddiy
information ia totallv unavailable for 80 pm-cent," he aoid. "Even if all the world^
identiBta directed their attention to tandcify tasting by traditional methods,
would be unable to test the chemicals which are covered bv mriating l^ialataon."
In li^t of this ijiUmina, to enaura our children'a good health, the protocols for
sdsntific research need to be changed. And concurrently, what you as Imslatois
used to do in order to saf^uard our children's health right now, is to take eve^
possible measure to guarantee our children's protection against environmental tone
anosures.
Many years ago, I had the fortunate opportunity to meet one of our coun^a great-
est statesman, 'me Honorable Jamea Delaney. We are pictured together here in Key
Biaeayne, Florida in 1973. When 1 asked the tiien retired Congressman what
" ' y Clause, he told me that he had Tost his beloved
face the tragedy of losing our five year old dauf^ter to the same deadly diaaaae.
The Delaney Claum of tite Food, Drug and Coametie Act (1958) has been the only
bri^t spot in the flawed regulatory regime. The clause prohibite any food additive
in processed food that "induces cancer in man or animal.
However, since its enactment, the provisions of the Delaney Gause prohibiting
carcinogens in processed foods have largely been ignored with respect to pestiddes.
Tlu promise of the Delaney Clause remains unfulfilled. The essential premise of the
diuse is simple: what we understand best about cardnogeiu ia the limited extent
rf<mr knowled^. The dauae is grounded in a policy of prevention: prohibiting the
addition of carcmogens in the food supply to prevent avoidable cancers in humane.
lUs approach waa deemed necessary by Congress, since the entire nation's popu-
lation would otherwise be routinely exposed to carcinc^ens in their daily diet.
Thia waa our daughter. She is featured on the cover of the June issue of B — The
&wuvnmental Magaxine. It is because of her and the countless other children
whose lives are being lost to cancer that we must make legislative changes ru)w to
eOBure the ftiture of genarationB to come,
I would like to shue with you now what parents who have lost children tragically
to cancer have learned, and what you as legislators and policy makers need to Know.
When children are stricken with cancer you Qsht for uieir lives. Your heart grows
cold at the thought that thev might die. The Battle vou wage is equal to all the
*oiid wars that nave every neen fought. To see children clinging to their mother
and fother for life, to gaze into their eyes and see hope dwindling ... to feel their
confusion when words can no longer be uttered or understood ... to watch as trust,
the very bond that j^ues them to our hips, slowly slips awaj; ... it is at these mo-
ments uiat you wiah you had never been bom, never to bear witness to such cruel^.
We all have our wounds. As Colette's parents, we will never forget her bravery.
She tau^t us not to be afraid to die. She proved to us that unconditional love lasta
fotevM*. It ia thia flame that bums deep in our hearts that brings us here toda^.
A mother's intuition never dies nor does it fade away. Supported now by new sd-
entific evidence, referred to earlier in my testimony, I am convinced that Colette's
death was due to a pestidde exposure. Had I known then the cardnogeiu that she
Or I were expoaed to, I would have had a choice. . . I could have found altematiuea.
I would lilce to share an intimate moment in our Uvea. Two oavs before Colette
died, as she lay in her bed, she looked at me intently and asked, "Momm^, why did
tUa have to happen to me? As her mother, I could not answer her question and to
tldt day Jim ana 1 have only her mission in our hearta and the hope that we the
pswle can make a diflisrence and we will
Snce the passing ef Colette four yean ago, not a day goes by that 1 dont think
■liout her and what could have caused her cancer.
How can it be that this government has forgotten about its children? How can you
SB legislators support a Contract for America that does not consider their environ-
flwntiil health and welt being? When we talk about health care reform we have a
responoibili^ to induda prevention.
1 apeak not only fbr myself and my husband, but on behalf of the countiess thou-
jands of mothers and others who have contacted me since the death of Colette and
iw start of our '•■'"p"g" in 1991. All are concerned about these issues and feel
DigmzcdbyGoOgle
138
hdpUu and frtutntad in not being giv«n tbe ri^t to know and the freedom to
choose u it reletee to the purchaeee of food atfo^ng the health of their children.
Am we review the laws tt the land which are written today, nowhere is it writteo
that children have the ri^t to a ufe a dean environment. Nowhere is it written
that children are protected from man-made chemicals that cause cancer; noiriien
is it written that the parents of these children end other citizens tt this oountrr
have the ri^t to know what ia the food they eat, the water they drink and the eir
they breathe.
It is for these reasons that we strongly encourage ^ou to support H.R 1771, the
Pesticide Safety and Right-to-Know Act ctf 1996. 1 praise you Congreaaman Waxmui
for your continuous efforts and determination to protect our nation's children.
Let us have the choice and the ri^t to know what is in our food and the product!
we consume. Let us begin with a new trust, a way in which we can restore koe
in our government which sadly is not providing us nor our children with the sue-
guards we deserve.
You have the opportunity today to start rioting this wrong by 'emendiDg' HR.
1627, The Pood Quality Protection Act of 1996, and supporting Tkt Pesticide StIMy
and Right-to-Know Act. ,
We urge you to err on the side of caution and as responsible legislators do whit -
you intuitively know in your heart is the right thing. In addition, we encourage jon t
to increase your support for environmental health research.
If we value the future of human life, as I know we all do, we must protect it |
If we value the future of human life, as I know we all do, we must pnmde for iti
safety. If we value the fUture of human life we must honor its existence.
We must honor our children for they are the cornerstones of our lives and our
nation. They are the fbture of America.
I thank you for this opportuni^ to share with you today and would be pleued
to answer any questions.
Mr. BiLiRAKls. Thank you, Ms. Chuda. I know it was very dif-
ficult for you. Thank you for having the courage to present your
testimony.
Dr. Landrigan.
STATEMENT OF PHUJP J. LANDRIGAN
Mr. Landrigan. Thank you, Mr. Chairman. I am Philip
Landrigan. I am a pediatrician and Professor of Pediatrics in Com-
munity Medicine at Mount Sinai in New York. I am here today be-
cause I was Chair of the Committee at the National Academy of
Sciences that in June, 1993, issued this report, "Pesticides in the
Diets of Infants and Children." What I would like to do is take a
moment or two to summarize with you the m^jor conclusions <tf
that report and then compare those conclusions to the two bills
that are before you now— H.R. 1627 and H.R. 1771.
Well, one major set of conclusions that we reached which will be
no surprise to anybody who has ever been around children is that
children are fundamentally different from adults and we took a
great deal of time to detail precisely how children differ from
adults,
First, of course, they are growing and developing — the nervous
systems, the immune systems, the reproductive organs of children
are undergoing development all through childhood. Because vital
connections stre being laid down, these developmental processes are
highly susceptible to being disrupted by any environmental toxins
or, particularly in the case of the nervous system, if damage is
done in early childhood, if the nervous system is injured during
critical windows of vulnerability, it is likely that the injury will be
life-long. The nervous system does not have veiy much capacity to
repair itself once iiyury has been sustained.
139
Second, children are very different from adults in their patterns
' exposure, in their diets and their patterns of exposure. For ex-
nple, the average child in the first 6 months of life drinks 7 times
I much water, pound for pound, as do most adults. Tbey eat many
mes more fruits and vegetables pound for pound than do adults.
What this means therefore is that any toxins that are present,
ny pesticides or other tcndns that are present in those puticular
>ods that comprise so great a part of children's diets, will result
1 proportionalfy very heavy exposures to kids.
Because chilu«n are young, because they have many more years
f life ahead of them than an adult, any diseases that are trig-
ered, initiated by exposures in those first few years of life wul
ave 6 or 7 decades in which to play out. By contrast, we have
iwer years ahead of us and any toxic exposures that we sustain
3 midlife £ire less likely than similar exposures sustained in early
hildhood to produce toxic effects.
It was for bH these reasons, in recognition of the very enhanced
xposures and the greater vulnerability of children as compared to
idults that our committee at the National Acadei^ of Sciences rec-
mimended very strongly that the Environmental ftxjtection A^ncy
ind the other r^ulatory agencies that are involved with pesticides
sodi^ the procedures that they use in setting pesticide toler-
inces — ^this is on page 8 of the Executive Summary — so that the
standards be based principally on considerations of protecting the
public health.
Pesticide tolerances are currently set through a balancing proc-
!B8, health considerations are trad«i ofT against economic and agri-
ultural considerations. We urge that primacy be given to the pro-
ection of public health in the setting of standards, that the balance
e tilted, in other words, in favor of children.
We made a series of specific recommendations for better data col-
N:tion and I was pleased to see that several of those provisions
'ere echoed in H.R. 1627 for better food surveys over sampling of
XhIs eaten by children, surveys of residues, better toxicity testmg
rocedures — those are clear strengths of H.R. 1627 over current
rocedures.
However, I was very, very much concerned by the decision that
as obviously been made by the framers of H.R. 1627 to quietly do
wa^ with the Delaney Clause. Now the Delaney Clause is not a
■erfect instrument. Anybody who has thought about pesticides
:iiows that. It is an absolute instrument. It does not embody cur-
ent state-of-the-art thinking and quantitative risk assessment.
You have taken testimony previously. I w£ts here on February
!nd. John Graham, my colleague from Harvard, talked about new
levelopments in risk assessment, and it is clear that the Delaney
i^lause does not embody those, but the thing is if you are going to
'brow away Delaney it's got to be replaced by something that is at
east as protective of children as the Delaney Clause is. For all its
mperfections the Delaney Clause has been a bulwark which for the
last 40 years or so has succeeded in protecting children against the
aost hazardous pesticides in the diet and it is not something that
hould be let go lightly.
As a pediatrician I am very worried about the negligible risk
tandard which is put forth in H.R. 1627. I am very much con-
DigilizcdbyGoOgle
140
cemed that it will allow continued trading off of economic against
health considerations in setting tolerances, and I would urge you
to go with H.R. 1771 and not to support H.R. 1627. Thank you.
niie prepared statement of Philip J. Landrigan follows:]
^1^
Mr. Cbairinan and membera of tha ■ubcominittee. Thank you veiy much for hav-
' Iff invitwl ma to teatJlV before you teday on the isoua of protaetion of infants snd
uldren uainat paatddaei in tha diet ana to comment speciflcally on H.R. 1771, the
Peatidde Safety and Ri^t'to-Know Act of 199S, as wall aa on H.R 1627, the Food
Quali^ Protectian Act of 1995.
My nama ia Philip J. Landilgan, M.D., M.Sc I am Profeaior and Chair <^tha D^
partment of Communis Medidne and EHrector of the Division of Eiivir<»uiMntd
and Occupational Madiana of the Mount Sinai School of Medicine in New Y«l Qtj,
Also I am a pediatrician and Profewor of Padiatrica at tha Mount Sinai School of
Medicine. Formerly I was a membar and then tha Chair of the Committee on Eovi-
ronmental Hazartla of the American Academy of Pediatrics. From 1988 through
June 1993 I served as Chair of the National Research Council (NRC) Committee on
Pestiddes in tha Diets of Infants and Children. This Committee issued its unani-
mous finsl report in June 1993.
7^ NRC Report on Patiddea and ChUdrtn
I would like to begin my tastimony today by summarizing the m^or finding) of
the 1993 NRC Reporf on Pattiddes in the Diets of Infants and Children.
The NRC report concluded that the CBderal regulatory qrstam currently in placo
in the United States does not adequately protect children against pestiddes in the
diet The (adaral government's current pMticide regulatoir program takes a one-
siie-fita-all approach. It ignores tha great diversity in diet tnat exists smong people
of different age groups. It fsils to recognize that children differ greatly tnm admt*
not only in ttieir size but alao in their metaboliam and in the food they eat
A fiuidamental tenet of pediatric madidne ia that children are not just Uttls
adults. They are in many ran>ects truly different. The NRC committee noted the fol-
lowing unique features m children:
• Children eat different foods fi<om adults and they eat them differently. Children
in the first 6 months of life drink 7 times as much water pound-per-pound as
the average adult. The average one-year-old drinks 21 timea more apple juice
and 11 times mora grape juice and eats 2-7 times more grapes, bananas, pears,
carrots and broccoli aa the average adult. In consequence of^their unusual diets,
children have substsntislly heavier exposures than adults to any pestiddes that
are present in their foods. Every dav thousands of American chUdren are ex-
posed to pesticides in food, milk and drinkins watar,
• Children'a metabolic pathwaya, eapedally in tne first months ailer birth, are im-
mature compared to those of adults. As a consequence of this biochemical imma-
turity, children's ability to metabolize, detoxify and excrete certain toxins is dif-
ferent from that of adults. In some instances, children are actually better able
than adults to deal with environmental toxins. More commonly, however, th^
are less well able than adults to deal with toxic chemicals and thus are more
vulnerable to them.
• Children are undergoing rapid growth and development, and their delicate devel-
opmental processes are easily disrupted. Many organ systems in young children
particularly the nervous system, the immune system and the reproductive or-
gans, undNgo veiy rapid growth and development in the first months and yean
of life. Strurtures are oeing developed and vital connections established. Indeed
development of Uie nervous system continues all throu^ childhood, as is evi-
denced by the fact that children continue progressively to acquire new skills ai
they grow and develop: crawling, walking, talking, reading, and writing. Thi
nervotis system in not well able to repair any structural damage that ia causae
by environmental toxins. Thus, if cells in the developing brain era destroyed bj
pesticides, or if vital connections tietween nerve cells Eul to fenn, thera is higl
risk that the reeulting neurobehavioral dysfUnction will be pomanent and irre
veraible. The consequences can be loss <n intelligence and alteration of norma
behavior.
• Beeauae children have more future years of life ahead of them than do mos
adults, they have more time to develop any chronic diseaaes that may be trig
gerod by Mriy environmental e^^osures. Many diseases that are triggared ^
.y^Xlglt
pMtiddea and other toxins In the environment require decades to develop. Ez-
amplaB include meBotbelioma caused byexposure to aabestoB, leukemia eauMd
by benzene, breaat cancer caused by DDT, and possibly some chronic neurolozie
disease* such as ParklMon's disease end Alzheimer's disease that nay be
I context toxic exposures sustained early in life appear
more likely to lead to disease than the same exposures encountered later in life.
To betto- protect the health of America's infants and children, the NRC Commit-
tee recommended strongly that the federal government take cognizance of children's
imique vulnerabilities end ecposures and revamp scientific and regulator; proce-
dures for controlling pesticide residues in children's diets. The Ckimmittee also rec-
ommended that the regulatory agencies adopt a new method of risk assessment that
will more accurately gauge the population at risk. And it urged that toxicity testing
of pesticides bw more comprehensive.
tliegoal ofourrepOTtwas to make the veiy good food supplv of the United States
even better. We did not say that parents should radically exchange their children's
diet* to avoid certain food*. On the contrary, we emphasized that parents should
continue to emphasize fruits and vegetables in their children's diet*. Nonetheless,
basic changes are needed in the current regulatory system to ensure that the foods
taten by all of our infanta and children are safe.
Toieranoea— defined as the levels of pestidde residues permitted on or in foods
when tbt^ leave the Uam — constitute the only legal mechanism for regulating pes-
A central recomraendatlon of the NRC Committee was that the federal govern-
ment must have as its clear goal the setting of tolerances that more fully protect
human health, particularly the health of infants and children. The Committee stat-
ed that children must be able at all times to eat a diet that is safe and healthful.
liie NRC Committee recommended that toxici^ testinz procedures should be de-
veloped that spedfically evaluate the vulnerabili^ of children. Of particular impor-
tance are testa for toxicity to the developing immune, nervous, and reproductive sys-
iW NRC report recommended that there should be a presumption of greater sua-
ceptibilitv of infants and children in the absence of evidence to the contrary. Cur-
rently, if animal tests show no adverse aCTect* for a peaticide at a certain exposure
level, then the level that is thought to be safe is determined by dividing that no-
efCsct level bjr 100. This account* for differences between humans and animal* a*
well as variaQtHi among humans, EPA then divides this number again by 10 if stud-
ies have shown affects on the developing fetus. The NRC report recommended use
of on additional 10-fold safety factor to account for differences between adults and
children.
Finally, the NRC Committee recommended that estimates of disease risk from
pesticides take into account changes in Mtposure and susceptibility that occur
throu^out a person's life. Children who are exposed to a carcinogen early in life
procedures and the standard settii^ process neea to take cognizance irf' this biologi-
cal difference. This difference constitutes a further rationale for the NRC rec-
ommendation of an additional lO-fold safety factor.
HJt. 1771. The Peeticide Safety and Right to Know Act ofl99S.
I commend you, Mr. Waiman, for having introduced H.R. 1771, the Pesticide
Safe^ and Ri^t to Know Act of 1996. In particular, I applaud you for having in-
cluded in this bill section 3 on the Protection of Children wluch states
"Ilie Administrator [of the Environmental Protection Agency] aholl before
prwcribing a tolerance for a pestidde chemical under tnis section, deter-
mine in writing whether dietaij enMSure to the pestidde chemical under
file tcderance bong prescribed for the peaticide chemical is reasonably an-
tidpated to cause cancer, damage to the develo[Hng neurological, immune,
or reproductive *y*tems or other serious adverse health effects in any child.
Tlie Administrator may not prescribe a tolerance for a pestidde chemical
tf tha Admhiistrator determines that dietary exposure to the peetidde
diemical under such tolerance i* reasonably anticipated to cause such ef-
fects In any child."
This strai^tforward, aensible and unambiguous proposal provides dear guide to
the federal regulatoiy agendes. It places protection of our nation'* children, and
thus of America's future as the dear goal of the national regulatory agenda. This
DigilizcdbyGoOgle
pnpoMl i* conai*l«ot with the iii«^r racommmdatioiw of the NBC report Thia pn-
poeu ii
tbeUn
HJt. 1627 AmtndmtnU to tht Federal Intietidde, Fungicide and Rodentiddt Ad,
(FIFRA) the Food Quaiity Protection Act of 1996.
Hu amendments to FIFRA that ham been proposed under H.R 1627 are not prO'
tactive of the health of children. These propoeals are not consistent with the miin
condusiona and recommendations of the report ti the NRC Committee on PestiddN
in the Diets of Infants and Children, iw
Instead of atatins unambiguous that the primaiy goal of pesticide regulatioa ii \
to protect human health H.R. 1627 directs the federiil agencte* merely to conrida" )
the aspects of pesticides on the health of children. Under subparagraph G, p59^,
H.R 1627 permits the federal agendea to balance the protection of children s health
against short-term economic conaideratioiis in setting tolerances for pesticidea.
H.R. 1627 talka at great length about the proceaaea that the federal agendea
ahould use to set pesticide standorda. But H.R. 1627 does not give primacj to the
protection of our children's health.
And finally H.R 1627 quietly abolishes the protection to children's health that (or
the past four decades has been embodied in the Delaney Clause. The Delane;
Clause unambiguously and unequivocally bans cancer-causing pesticides that cod-
centrate in processed foods. H.R. 1627 would abolish this straight-forward approach
to the protection of our children and replace it with an ambiguous "negligible risk'
standard, which would permit EPA to balance children's h<»lth against economic
and other factors in regulating pesticides.
The Delaney Clause u not a perfect instrument. It does not embody the latest devel-
opments in quantitative risk assessment. But despite its shortcomings, the DeUmey
Clause is a powerful piece of legislation that has served to protect several generations
of American children against carcinogenic pesticides. As a pediatrician, I would be
willing to see the Delaney Clause removed from FIFRA, if it were replaced by lan-
guage directing the federal agencies to employ state-of-the-art science to provide clear-
protection for America's children against toxic pesticides. But in my opinion, the dis-
memberment of the Delaney Clause proposed in H.R. 1627 is wrong. It should not
be enacted into law. It is not health-based. H.R. 1627 protects pesticides, not chil-
dren.
Conclusion. In sununaty, Mr. Chairman, infants and children in the United States
are heavily and regularly ocposed to pesticides in their dieta. These pesticides in
elude compounds that have been demonstrated to be cardnogenic, neurotoxic. Uadi. •=
to the immune system and toidc to the reproductive organs. The federal regulator.^ ■
avstems currently in place do not provide adequate protection to our infants ani — "^
cnildren against these residues of pesticides.
The inddence of cancer in Amence's children is increasing. Each year for the paa ■
20 vears the inddence of the two most common forms of childhood cancer — leukemi^^
ana brain cancer — has increased in the United States. Death rates from these ti^»^-
mors are down, because of advances in pediatric therapy, but inddence is up. F(^ =7
acu^ lymphocyte leukemia, the most common form of leiuiemia among children, th_ -^
cumulative increase in incidence rate over the past 20 years has been 20 per cen-^K.
I do not know whether pestidde expoBure ii responsible in part for these mcrease^n^
in childhood cancer. However, prudence suggests that the widespread exposure c^^J
our children to carcinogenic and other toxic chemicals cannot be good for the^^^i
health.
The legislation that you have proposed, H.R. 1771, represents an important st^^SP
to strengthen existing federal pesticide regulation in the United States. It will pr«
vide strong protections for the health of all of America's children. By contrast, H.I
1627 la bad legislation. It will perpetuate the current inadequately controlled ezp
sure of children to pestiddes in their diets and indeed through its abolition of u
Delaney Clause, H.R. 1627 will likely worsen our children's exposure to peatidr'
"nie niture of our nation depends upon our children. Our children are th
and most vulnerable members of our sodety. but they are the future of oi
If our nation is to survive strong into the next century, it is not we, but rather '^
will be our children who will carry on. We have a responaibilitv to our children. ^^^*
have a responsibility to protect tneir heaith to give them childhoods that are ft- •*
of preventame disease and free of toxic exposures. The provisions that you have o^J*^
liiwd in H.R 1771 will achieve these goals. I applaud you for your courage and xifr
your vision in having introduced this legislation.
I shall be pleased to answer any questions.
Thank you.
dbyGoOgk''
143
Mr. BnjRAKls. Thank you very much, doctor Mr. Eichler.
STATEMENT OF BOB EICHUXt
Mr. Eichler. Mr. Chairman and distinguished members of the
comniittee, thank you for the opportunity to testify today. I am Bob
Eichler, resident of the city of Portage, Michigan, and tne father of
two teenage daughters. I have lived through the complexities of
parenthood for nearly 20 years. I am here today as a consumer of
foods that young children eat, not as an expert on pesticides.
My wife and I have been in the child c£ire business since the
1970's. We are actively involved in the Southwestern Michigan As-
sociation for the Education of Young Children. Along with this, I
am currently a consultant for Child Care Resources, an organiza-
tion offering comprehensive information and services in the area of
child care in soutnwestem Michigan.
I am concerned about knowing if dangerous pesticides are on the
foods we eat. I would like to be made aw£ire if known or probable
carcinogens are present on this food. This would help aid our selec-
tion of certain foods for my family and for the children in our care.
When you were a little boy or a girl, you took a delicious red
apple or peach from the refrigerator ana your mother or father
said, don't forget to wash it. Did you always? Did you as a child
worry that not washing it might harm you? Did you realize that
even if you did wash it, you might not get the pesticides off? Thank
goodness for parents and other adults protecting children.
Young children eat less food overall but often consume large
quantities of certain foods. I know we feed young children a great
deal of fresh fruits and vegetables. Knowledge of pesticides through
labeling would aid us in determining which fruits or vegetables we
would select.
I was in the grocery store this past weekend and saw some dried
apricots. I noticed it said "Turkish Apricots, contains sulfur diox-
ide," I had no idea if sulfur dioxide was a preservative, a pesticide
or a flavor enhancer. I asked a clerk and he informed me that sul-
fur dioxide was a color enhancer and that some people were aller-
gic to it. That rung a bell in my head.
I went home, looked up sulfur to be an ingredient in gun powder,
rubber vulcanization and insecticides. This inspired me to pull out
my nutrition file and I saw a brochure on sulfites. Here, I learned
^at sulfites not only have caused severe reactions in some people
and problems with asthmatics but it has actually been linked to
several deaths. That is pretty serious for just adding color to some
foods.
Th& point here is that labeling can help people make the choice.
Remember, in my case, we buy food not only for ourselves but for
other people's children. For us, just having the knowledge at our
purchase point could help us to decide if we want a particular food
or not.
I come here today not as a liberal or a conservative, a Democrat
or a Republican but as a realist. Every one of us has probably come
in contact with or known someone who has had a problem with pol-
lution or pesticides.
I have a friend who built a home in the 1960'8. By 1990, their
drinking water in their well was determined too polluted to
DigilizcdbyGoOgle
144
conaunie due to nearby farm chemicala. Chemicals used in only the
last century have already got down that far into the earth.
I grew up in Berrien County, Michigan, the heart of the fruit
belt. My grandparents owned a fruit farm and helped create a local
fruit exchange. As a young boy I picked several fruits and I have
empathy witn those who are involved with food production. At the
same time, recording the use of pesticides at the very least would
help us determine where future problems could be averted.
I have another fHend who works as a veterinarian's assistant in
a clinic and has seen several animals who have been diagnosed
with chemical poisoning due to eating pesticides off treated lawns.
Something has to be done to control known and probable carcino-
genic pesticides. At the very least, labeling of products would help
the consumer make purchasing decisions. It would seem even to
the layman the most common sense thing to do.
Thank you again, committee members, for giving roe this oppor-
tunity to speak up for the voice of today's children ^md securing a
healtny diet for the present and future existence in our world.
Mr. BILIRAKIS. Thank you, Mr. Eichler.
Dr. Reigart.
STATEMENT OF J. ROUTT REIGART
Mr. Reigart. Mr. Chairman, members of the subcommittee, m;
name is Routt Reigart. I am a professor of pediatrics at the Medical
University of South Carolina where I am involved in ^e practice
of general pediatrics and environmental medicine. I smi chairpenon
of the Committee on Environmental Health of the American Acad-
emy of Pediatrics. I come to speak to you today as a representative
of the more than 48,000 memners of the American Academy of Pe-
diatrics.
Since the American Academy of Pediatrics has not officially
taken a position on H.R. 1627, my testimony will focus primarily
on the principles used by the academy to judge such legislation, I
believe, and I think all of you will agree, that H.R. 1627 falls far
short of meeting these requirementa for Academy support.
Moat of the members of the Academy of Pediatrics are practicing
physicians who care for children and counsel parents. Most know
a great deal about infant and childhood nutrition. In this conteit,
they expect parents and specialists in risk assessment to provide
them with adequate information about the risks of pesticiaes and
other chemicals in food to allow them to make appropriate rec-
ommendations to their parents. They would like to be aole to Si^,
without qualification, your infant or child should eat a diet rich in
fruits ana vegetables.
Pediatricians also should be able to make several additional af-
firmative statements. Pesticides used on our food have been tested
for safety to infanta and children. The risk assessment process hu
taken into account the difference in children's diets, including diet
selection and higher caloric intake. The risk assessment has taken
into account the differences in the way children absorb, metabolize,
store and clear chemicals and other toxins from their bodies. The
risk assessment has taken into account special susceptibility to in-
jury of developing organ systems, particularly the nervous system,
endocrine, lung and immune systems of infants and children.
DigilizcdbyGoOgle
145
The use of pesticides is regulated and regulations are enforced to
nsure that pesticides are used in a safe and proper fashion.
During the several years I have worked with the Committee on
Invlronmental Health in the Academy of Pediatrics, there has
een dramatic shift in the levels of concern with various end points
* injury. Longstanding concerns about carcinogens in our diet re-
tain of interest to the public and pediatricians. However, there
aa been a marked increase in the understanding of noncancer
idpoints.
We have become increasingly concerned that many children may
e suffering significant neurologic impairment, alteration of endo-
rine function and hormonally derived behaviors and perhaps im-
lune suppression. Perhaps the most primary dictum in medicine
1 a Latin phrase that translates, Tirst do no harm." It reminds
hysicians that it is often possible, with the best intentions, to at-
empt an intervention or therapy and subsequently find out that
uch therapy did more harm than good. This usually occurs when
re are insumciently cautious in our prior testing of the new inter-
ention for safety while focusing on apparent benefit.
The use of pesticides and setting of tolerances without sufficient
onsideration of the risk to children, which has been the routine
ractice in the past, clearly violates this dictum and will inevitably
>ad to harm to children.
The Academy of Pediatrics strongly supports strong health-based
andards for tolerance setting for pesticides at the actual levels to
hich children may be exposed. Tolerances should ensure that the
^ual foods eaten by chil<u«n at the actual levels of intake are safe
r them. Again, the principle is, first do no harm. Whatever the
leged benefit of exposing a child to a pesticide, such benefit
lould not be obtained by impairing the health of our children.
It is well to consider issues of responsibility and credibility. It is
early the responsibility of manufacturers, formulators and appli-
Ltors of pesticides and the government to ensure that our food is
ife for our children. If this responsibility is not clearly met in a
"edible fashion, our children will suffer.
Many of the actions of the public, including the increasing popu-
irity of so-called organically grown foods, reflect a public lack of
niBt in this process. In other words, the present efforts appear to
ick credibility with the public and medical community. This credi-
Uity will only be gained and trust established by strong efforts to
nsure the safety for children of our food supply. It is my own view
ased on my own experiences that many families and physicians
re very concerned that there is bo little information regarding the
afety for infants and children of pesticides in our food. This con-
em will only be allayed by strong legislation and careful formula-
ion and vigorous enforcement of regulations.
Since children cannot make their own choices in food selection,
liey are unwilling victims of any errors we make in the risk as-
ssament and regulatory process. We owe them the highest level of
rotection possible. They deserve the highest level of protection
jssible.
Thank you, Mr. Chairman. I will answer any questions.
[The prepared statement of J. Routt Reigart follows:]
DigilizcdbyGoOgle
■ profeHor at pediatrics at the Medical Univer^
■ity of South Caivlina wnen I am inmlved in tlw practice ef general peAabrics and
environmental medicine. I am the Chairperaon ef uie Committee on Environmental
Health of the American Academy of Peoiatrica. I come to apeak to you todav as a
repreaentative of the more than 48,000 membera of the American A<»demv oi Pedi-
atricB. Moat of theee members are practicing physiGiaiis who care for children and
counsel parents on a daily basis. Ta^ are familUr with the concmta of risk assees-
m«nt, but few are expert* in perfonnlng formal risk atieaamenti. Moat know a great
deal about infant and childhood nutrition and are comfortable in providing counsel-
ing to the parents tt their patienta regarding appropriate nutritional practioea. In
i contert, they expect experts and spedausta in risk assessment to provide to
...im adequate information about tht ~~ " ' "" -^ .1-- .1 ._.!__._■. »--i
to allow them to make appropriate r
like to be able to aay, vntnout qualifu;auuu, luiu uuwii »■ uwu muuiu mi. ■ uisi
rich in fruits and VMetables. You need not be concerned about hazards of pesticides
in your selection of miita and vegetable* for your child.'
In addition, when asked about the haxards of pesticides in food, pediatridana
should be able to make several additional afBnnative statements:
1. Testiddea used on our food have been teeted for safe^ to infants and chil-
2. "The risk asaessment proceu has taken into account the differencea in chil-
dren's diets indudina diet selection snd the higher caloric intake of infanta relative
to their body weight.
3. "The risk aaaeaament proceaa has taken into account the differences in the way
children absorb, metabolize, store, and dear chemicals and other toxins &om thrar
bodies."
4. The risk sssessment has taken into account special susceptibili^ to iqjuiy of
developing organs systems, particularly the developing nervous, raiaocrine, lung,
and inunune systems of infants and children."
6. "Tb* use of pestiddes is rwulated and regulations are enlftrced to ensure that
pestiddea are used in a safo and proper fashion."
6. Toods which are available in the marketplace have been inspected to enouro
that they do not contain pestidde residues which exceed approved limita which are
based on an appropriate risk assessment process which has taken spedfically into
account risks to children and infants."
In the several years that 1 have worked with the Committee on Environmental
Health of the Academy of Pediatrics, there has been a dramatic shift in the levels
of concern with various end points of injury from pestiddes to children. Long stand-
ing concerns about eardnonais in our diet remain of int«rest to the puUic and pedl-
■tridans. However, there has been a marked increase in the understanding tn the
risk of non-cancer endpoints of chemicals in our environmental and our taet. We
have become increasin^y concerned that many children mav be sufEsring significant
neurologic impairment, alteration of endocrine ftinction ana hormonally dmved be-
haviors, and perhaps inunune suppression, by exposure of the fetus, infant, and
newborn.
Perhaps the most primary dictum in medidne is embodied in the Latin phrase
TVtmum non nocert whidt is ususllv translated "First do no harm". It reminds
physidana that it ia often possible, with the best intentions, to attempt an interven-
tion or therapy, and subsequently find out that such therapy did more harm than
f[ood. lliis unudly occurs onlv when we are insuffidently cautious in our prior tast-
ing of the new intervention tor sofe^, while focusing on the apparent tMOwfit. The
use of pestiddes and setting of tolerances without suffident consideration of the
risks to children (which has been the routine practice in the past) dearly vidates
this dictum, and will inevitably lead to harm to children.
The American Academy of I^Mliatrics strongly supports strong health based stand-
ards for tolerance setting for pestiddes at the adnial levels to which children may
be expoeed. Consideration in ensuring the health of our children must take into ac-
count their diet, metabolism, and spedal susceptibilities. Tolerances should ensure
that the actual foods eaten l»r children at the actual levels of intake are safe for
them. Again, the prindple is "^rst do no harm". Whatever the alleged benefit of ex-
posing a child to pestiadea, such benefits should not be obtained by impairing the
nealtn of our chiloren.
The American Academy of Pediatrics believes, given the available information on
the risks of pesticides in the diet, that it is prudent to recommend that itdisnts and
^lildren be provided a diet rich in fruits and v^etables. No known risk from pes-
igilizodbXiOOgle
tiddM pTNHitlT autmi^ Uie bmrnOU ot thia hMlthfUl diet The Academy of Pedi-
■bica alao unaentanda the benefita of peaticideB to agriculture and accept* the
pnpoeition that it is poeaible to use paatiddea in a faahion which ia not hazardoua
to ue hsalth cf in&nta and children. It ia not potaible to uae peaticidee in euch a
faahion without knowledge cf the actual riaki to mfknta and diildren. At the present
time it ia dear that it ia not poMible to itate that peatiddei have been evaluated
fiH" aafe^ to children and their apedal needa.
It is well to conaider issues ot reqmnaibilil^ and credibilily. It is clearly the re-
Vonsibili^ of manufacturers, formulators, ana applicators of pesticides and the gov-
ernment to enaure that our food ia safB for our ouldren. If this reaponstbility is not
eleariy met in a credible fashion, our (Mdren will suffer. Many of the actions of
the public, including the increaaing popularity of "organically grown" (bods, reflect
a niUic lack of trust in thia process, in other words, the present efforts appear to
lack credibiliW with the public and the medical community. Thia credibility wUl only
be gained ana trust established by strong efforts to ensure the safety for children
of our food supply It ia my own view, based on my own e^teriences, that many fami-
lies and phvnaana are veiy concerned that there is so little information regarding
the aafit^ for infanta and children of peaticidei in our food. This concern will only
be allaved by strcmg l^islation and care&l formulation and vigorous enforcement
of r^ulations.
Since children cannot make their own choices in food selection, they are potential
unwiUins victims of any errors we make in the risk assessment and regulatory proc-
esses. We owe them the highest level of protection possible. They deserve the fiigh-
est level ot protection passible.
Mr. BlURAKls. Thank you. Doctor.
Dr. Wolff, your opening statement, please.
STATEMENT OF MARY 8. WOLFF
Ms. Wolff. Thank you. I am here in my role as a scientist in-
volved in breast cancer research to support Mr. Waxman's position
on H.R. 1771 and I am going to briefly summarize what is already
in my statement.
We know that chemicals, a number of chemicals cause breast
cancer in animals and there is growing evidence that chemicals
cause breast cancer in women as well. And there is further warn-
ing in the growing evidence about chemical exposures and how
they affect hormonal activity in both humsms and animals and this
is especially important with respect to breast cancer because we
know that it is so strongly related to hormon2d factors.
Some of the changes that are seen in this hormonid activity are
to cause early puberty in animals, to cause gender modification in
women. It has been associated with a shortened — DDT has been
associated with a shortened duration of lactation and very recently
there has been a report in the scientific joumEtl, Nature, that tallu
about DDT in the rat and how it is an anti-androgen.
So there is a range of chemical activitv that may be vety impor>
tant with respect to breast cancer. In aadition, we are aware that
breast cancer rates are rising, that they affect millions of women
worldwide and that, while we don't know the exact causes, that the
environment is indeed involved.
Since there are no known medical mefins of prevention, it is real-
ly essential that we try to follow smd take advantage of prevention
of exposures that may help ameliorate this disease.
I previously supported Mr. Waxman's bill to regulate hormonal
exposures which was a real visionary approach and an issue that
was a challenge to both science and policy and that also is suited
to the issues we are talking about here today. I think it is espe-
cially fitting that we 2ire talking about both children and breast
DigilizcdbyGoOgle
148
cancer on the same panel. There is a great deal of interest tod^
in breast cancer research on exposures to young children and
young adults and how those may particularly make young women
predisposed to breast cancer.
Therefore, I want to support H.R. 1771 and its intention to pre-
vent exposures that may cause this disease.
[The prepared statement of Mary S. WoUf follows:]
My name i» Ma^ S. Wolff, Ph.D. I am ProfeMor in the Diviaion of Envlrotuneiita]
and Occupational Medicina of the Dapartmant of Community Medicina at the Mount
Sinai Scbool of Medicine, which is part of the Ci^ Univeraity of New York. My re-
■earch in environmental health haa centered on ^uantitating expoaurea of hui
to chemicals that occur in the environment, indudint; air pollutanta, pe-"-''—
poly^dic aromatic Iwdrocarbona, aolventa, and halogenatm hvdrocanM
to chemicals that occur in the environment indudint; air pollutanta, pesticides, lead,
poly^dic aromatic Iwdrocarbons, aolventa, and halogenatm hvdrocanMna.
HR 1771 ia intenoed in part to prevent toxic e^xmiFes that may be related to
breaat cancer. I am hare to addreaa the importance of environmental chemical tx^o-
■urea to liak of breaat cancer. Interest in this iasue haa ariaen partly becauae of
■tudiea in our laboratories and othera that have ahown a link with breast cancer
and DDT exposure. Our published report* have been performed in collaboration
with colleagues at Hartford Hospital (Dr. Frank Falck and othera),* at the New
Yotk UnivenlW institute ui Environmental Medicine (Dr. Paolo Toniolo and oth-
ers),' and at tne Kaiser Besearch Institute in Califiniua (Dr. Nancy Kri^er and
others).* A number of additjonal reaearch studies are now underway to extmd and
confirm these findings.
The search for environmental causes of bresat cancer b^an because of our inabil-
i^ to explain the riak to any large extent. Rates of breast cancer are rising in this
countt7, and neither the imderlymg causes of these diseases nor the reason for the
rising rates are known. We know tnat environment is somehow related to risk, be-
cause of vast geographic differences in rates, for example. We also know that for
breast cancer, reproductive hormone* are a mtOor contributor.
Attention has been fbcussed on environmental chemicals including pesticides and
plastidien and their potentlon contribution to breast cancer risk because many are
carcinogenic and because they can impair reproductive capaci^ of wildlife. In lab-
oratory tests, manyenvinmmental contaminants have been fbund to act like repro-
ductive hormone*. Therefbre, one mechanism by which chemical exposure* may con-
spire to contribute to csncer is bv mimicking hormones. Both women and men may
be affected b^ these exposure*. Hormones are also thoui^t to play a role in prostate
csncer, ovarian cancer, uterine cancer, testicular cancer, and colon caitcer. Indeed,
hormonal disruption may be associated with a broad range of biolc^cal effects: re-
productive dysfunction, neurologicsl problem*, and immunological difficulties.
More and more evidence exists about the hormonal action of environmental con-
taminants. DDT and DES can hasten the onset of puberty in animals. On the other
hand, TCDD (dioxin) can delay it. In women, early puberbr is a tiak bctcn* for breast
cancer. These effects are also related biolofl^cally to gender modification in turties
and alligators, with which we are all famiTiar « ° AnothM" hormonal eSect of DlXr
haa been found by Walter Ro„
In two studies, they found that women ii ^^.
levels of DDE also breastfsd for shcn-ter periods.' '' Recentiy we have learned that
DDT can act a* an anti-ondrc^n in the rat, counteracting male hormones and
iia;y add to the body's hormone burden or they may affect the hormonal balance,
as in the level of estrogen relative to that of anuogen (i.e. testosterone).
In addition to hormone disruption, a number of chemicals are known to act
through other routes in animals to eauae breast cancer (e.g. pnthloroethylene,
polycydic aromatic hydrocarbons), although links to breast cancer in women are
only now beginning to emerge. Most chemical exposures in this categoiy are difficult
to measure in humans, especially long after exposure occur*. But there are some
important recent findings. Of SMdal note is the report fi-om investigatora at the
New York State Departanent of Health who used a unique geiwraphic method to as-
sess expoaure according to street address. They fi>und elevatedrisk of breast cancer
on Long Island asaodated with residence nesr potentially hazardoua chemical fadli-
MS
tieB.x* Investigators at ths Natioiul Cancer Institute alao reported breast cancer
rates elevated among occupstion with s number of chemical exposures." These are
early leads that will De followed up by investigations that attempt to more precisely
measure exposure to environmental agents in relation to risk.
Exposure to environmental chemicals must be considered as possiblepreventable
risk factors for breast cancer and other hormonally related diseases. Tnis is espe-
cially true for breast cancer, because it affects so many women and their families,
and because we have not beien able to identify other means of preventing this dev-
astating disease. We know that environment is important, but the exact reasons
have eluded definition. We have banned many chcmucals which fit into this cat-
^n7, especially those that are bi<dogically persistent and carcinogenic in animals
(DDT, chiordane, hexachlorobenzene, PCBs and PBBs). But their continuing pres-
ence in the environment makes it possible for us to detect them even now in Amer-
ican men and women. There are numerous other hormonally active chemicals now
in commerce, including atrazine and metho]^chlor, which are of concern. New
chemicale should be equated for their hormonal potential, as Congressman Wax-
man has previously recommended.
Because so little is known about breast cancer causation, we cannot ignore the
posslblUly that chemical enwsures may play a rde in this disease. Rates of breast
cancer occurring in the U.S. have risen steadily since 1940. During that same pe-
riod, levels of pesticide and PCB residues in human adipose tissue in the U.S. have
shown parallel increases. We cannot now prevent breast cancer through known risk
factors. But environmental exposures to harmful chemicals can be avoided, and
therefore diseases associated with sudi chemicals may then be prevented. Therefore
the efforts of this ecnnmittee to protect health by preventing adverse environmental
is of the greatest importance.
REFERENCES
>F*kk FT, Rkd A, Jr, WoUT MS, Godbold J, Decken J; PeMJddra sod polyefalorinated
Upbenyl redduei in human bruit lipidi and thair relation to breiit cancer. Aicb Environ
HMlth 47: 143-146, 1993.
iWoUT MS, Toniob P, Lee E, Rlvira M. Dublii N. Blood lerel* oT orgaaochlorine residue* and
risk of breait cancer. J NaU CencM- InaC Sfi; 648-662. 1993.
■Krieger N, WoUT MS, Hiatt RA, Rivari M, Vi^Blinan J, Orentraich N. Breast cancer and
ienim ornnochlorinei: a proapectiTe Rudy amona white, black, and Allan woman. JNCI 86:
6S9-699, »»4.
*Guilleta U, Oraaa T8, Maaaon QR, Hatter JM, Perdval HF, Woodward AR. Davelopmental
abnonnalitiei of the gonad and abnonnal lex hormone concentrationi in juvenile alligaton from
contaminated and control lakei in Florida. Environ health perap 102: 660-688, 1994,
■Bergeron JM, Crews D, MeLacblan.JA PCS* as enTlnnineDtal eatrcmna: turtle aez dMar-
minatlon aa a biomarker oT envlmnmental contamination. Environ health parap 102: TBO-TSl,
1994.
■Rogan WJ, Gladen BC, McIUnney JD, Carreraa N, Haidy P, Thulten J. Tingelatad J, Tully
H. Po^reblorlnated blpheeyU (PCB() end dichlondlphenyldidilorMthan* (DDE) in human milk:
effteta on Biowth, motUdlty, and duration of IwMtlon. Am J pub health 77: 1294-1297 1967.
'ffladan BC, Rogan WJ. DDE and ihortened duration of lactation in a northern Mexican
town. Amerj pidll health 86: 604-608, 1996.
■Kelce WR, Stone CR, Lawa SC, Gray L£, Kemppainen JA Wilaon EM. Peniitent DI>T
natabollta pj>-DDE ii a potent androgen reoei * '-" "-' — "" "" "" ■"""*
*Keke WR; Monoesan E; Oamoik MP; !
disruptora: evidence that vincknolln davelo;
matsbolites. Toxlcol-^Md-FharmaeoL 126: 276-OC 1994.
»MaUua JM, Lewis-Mcbl EL, Kallenbaeh LR, Ju CL, Talbot TO, ORR MF, Lauridaen PE.
IT industries and high traffle araaa and the riak of breaat cancer on Long Island,
Rsnolt from the NYS DOH, April 1994.
"Cantor KP, Stewart PA Biinton LA Dosamed M. Occupational
'^ ' ' mortali^ in the United Stataa. JOEM 37: 336-348, IS
Mr. BiLQUKis. Thank you very much. Doctor.
Mr. Hopkins for your opening statement, please, sir.
STATEMENT OP EDWARD HOPKmS
Mr. Hopkins. Thank you, Mr. Chairman and members of the
oommittee for the opportunity to testify here today. My name is Ed
HopkiiiB. I am environmental director of Citizen Action, the Na-
tion's lareest consumer and environmental organization with 3 mil-
lion members in 33 States.
DigilizcdbyGoOgle
150
In our view, the most important task before Congress as it ad —
dresses pesticide reform should be to ensure that pesticide toler-
ances protect infants and children and after a 6-year effort, we now
have an excellent blueprint before us to do that. If Congress enacts
H.R. 1627, however, we are concerned that it will make an already
weak regulatory system even worse and I would like to focus on
how, in addition to repealing the Delaney Clause, which has re-
ceived most of the attention, the provisions of H.R. 1627 would ac-
tually weaken health standards in several other respects.
First, H.R. 1627 weakens current standards for pesticides in raw
foods by requiring EPA to set tolerances based on benefits, eco-
nomic benefits, to food producers. When granting a tolerance now
under Section 408, EPA considers benefits to consumers of an ade-
quate and wholesome and economical food supply. Under H.R.
1627, EPA would be required to consider the benefits of a pes-
ticide's use to growers. EPA could establish a tolerance that would
carry a risk to consumers which would be greater than negligible
if it found that growers in aparticular region needed that pesticide
to produce a specific crop. The public would bear the health risks,
the producers would reap the economic benefits.
The NAS report specincally criticized the practice of establishing
tolerances which are not based principally on health consider-
ations. In requiring the EPA to consider regional growers' ability
to produce crops, H.R. 1627 takes policy in exactly the opposite di-
rection from that recommended by the NAS report.
Second, H.R. 1627 weakens current standards for pesticides in
processed food. Current Section 409 tolerances allow no consider-
ation of benefits, simply requiring that food additives in question,
such as concentrating pesticide residues, be sjife. This hsis oeen in-
terpreted in current case law to mean that there is a reasonable
certainty of no harm. H.R. 1627 replaces this standard with a
much weaker negligible risk, consumer risk and producer benefit
standard that I just described.
Third, H.R. 1627 weakens current standards for noncarcinogens
in food. Much of the legislative debate has been about carcinogens
but children's exposure to noncarcinogens, particularly neurotoxins,
received considerable attention in the NAS report. H.R. 1627 would
weaken standards for these pesticides in food.
Current standards do no permit a negligible risk of birth defects
from pesticides in food. They apply s^ety stand£u*d8 designed to
prevent no birth defects at all. Similsirly, the standards do not per-
mit a negligible amount of brain and central nervous system tox-
icity; they are designed to prevent it from occurring at all.
H.R. 1627 would substantially weaken this. Rather than striving
for no risk of these noncancer effects, iwulators could tillow higher
risks of — higher levels of pesticides in food as long as the risks of
human health damage were negligible, possibly diluted to provide
economic benefits to reponal producers again.
Because of these and other deficiencies, we strongly urge Con-
gress not to enact H.R. 1627. But, if it does, it shoula at least miti-
gate the damage that that bill would cause and provide a minimum
of consumer protection by pEissing H.R. 1771. This bill contains
three elements of great importance to consumers. We think it pro-
vides a much more certain road toward carrying out the rec-
DigmzcAiyGoOgle
ommendations of the National Academy of Sciences report because
it specifically directs EPA to do that.
Second, we also think it is a common sense policy not to permit
cancer-causing chemicals in the food supply. But if Congress de-
cides to allow these chemicfds in food, it should at least require a
notice when consumers are eating food that has been sprayed with
known or probable human carcinogens. This notice serves two pur-
poses. First, it gives consumers knowledge about the product and
the choice of choosing an alternative. Second, it will give food pro-
ducers an incentive not to use known or probable carcinogens.
If it is good public policy for people to have information on food's
nutritionaj beneftts, like fat or sodium or cholesterol, it seems
equally reasonable for people to know about cancer-causing pes-
ticides that were applied to the food.
Thank you, Mr. Chairman.
[The prepared statement of Edward Hopkins follows:]
Prepased Statement of Ed Hopkins, Envihonmental Director, CmzBN Action
Mr. Chairman, distinguished member* of the subcommittee, thank you for the op-
portunity to testify today on pesticide and food safety legislation your committee is
considenng. I am Ed Hopkins, Environmental Director of Citiien Action, the na-
tion's largest consumer and environmental organization with three million members
in 33 states.
For years, .evidence has been growing that current pesticide policies are broken
and badly in nsed of repair.
■ The 1993 National Academy of Sciences (NAS) study, Pesticides in the Diets of In-
fants and Children, concluded that the current pesticide tolerance system fails
to protect children.
• More than 20 General Accounting OfGce reports over the last 16 years have
critiqued EPA's and PDA's pesticide programs. In virtually every area, from
delays in re-registration to inadequate monitoring and enforcement, these re-
ports reinforce the impression that the existing regulatory system has not done
a good job protecting consumers.
• nie^ pestieides on food are a routine occurrence, even after foods are washed,
peeled and ready for consumption, as demonstrated by a recent Environmental
Working Group analysis (Forbidden Fruit: Illegal Pesticides in the U.S. Food
Supply, 1995). Inadequate enforcement tools leave the Food and Drug Adminis-
tration ill -equipped to curb these violations by imposing effective sanctions.
• A complex regulator structure combined with inadequate resources means that
it routinely takes EPA many years to reach a conclusion about a pesticide once
a serious public health problem has been raised. These lengthy delays do little
to build consumer confidence in the government's ability to sueguard the food
supply from pesticides.
• While some farmers have demonstrated convincingly that it is possible end even
profitable to grow food using fewer chemical pesticides, most iarmers have few
incentives and scant governmental support for reducing their pestidde use.
The policies embodied in H.R. 1627 wUl solve none of these problems. If Congress
enacts H.R. 1627, it will moke an already inadequate pesticide regulatory system
worse, A combination of fundamental policy changes would weaken current stand-
ards and allow more pestiddes in the food supply, increasing risks of cancer, birOi
defects, and damage to the neurological and immune systems. Some of the most im-
portant changes include the following: substituting a vague "negligible" risk stand-
srd for the Delaney Clause and weakening the law's other health protection stand-
ards; shifting the burden of proof that pesticides meet current health and safety
standards to EPA from the pesticide registrant; requiring EPA to dilute health-
based standards by accounting for agricultural practices, a policy the National Aead-
3 of Sciences report on infants and children spedfically criticized^ making it vir-
y impoBBlble for states to set health protection standards or even require
warnings; and creating a strong presumption that food safe^ standards established
under the CODEX should override U.S. pestidde tolerances.
DigilizcdbyGoOgle
HJl 1627 Wtaktn* Currvnt Health Standarda
I Mpecially wont to highlight the potential eSects of some of the propoaed le|^a-
tive change* on children s health, Con^«M is in a strong position to enact l^iila-
tion to protect the health of infanta ana children from peatiddea, based on the five-
year NAS report completed ir '"""
ceming food consumption of infianta and children. It also contains a general require-
ment uiat the EPA develop and implement procedures that ensure that pesticide
tolerances safeguard children's health.
In reality, however, the provisions in H.R. 1627 would actually weaken children'*
protactiona from peatiddeB in three respects (in addition to repealing the Delaney
Clause), and in other ways prevent Oie EPA from carrying out the NAS ree-
ommendationa if it tried to do so. Several provisions in Ihe biD support this asser-
H.R. 1627 ureakeru current atandard* forpeatiddts in raw foods by requiring EPA
to mt toUranctt baatd on henefita to food producer: When grantiiig a tolerance
under Section 406, the regulatory system requires EPA to consider benefits to con-
sumers of an adequate, wholesome and economical food supply. The nutritional and
economic benefits to consumerB of a wholesome, abundant food supply are weighed
T'.nst the health risks which the use of pestiddes pose to consumers,
nder H.R. 1627, EPA would be required to consider the benefits of a peatidde's
use to grower*. The EPA could establish a tolerance that would carry a nak to con-
sumers which would be greater than "negligible" if it found that growers in a par-
ticular region needed that peetidde to produce a specific crop. So the benefits EPA
would consider moA use to justlify a hiE^ier tolerance if H.R. 1627 were to become
law are not benefits to consumers, but economic benefits to growers.
Here's how this could work: Under current law, a temporary $26 million loss to
the dtrus industry would be measured in terms of it* effect on the availability and
price of dtrus products in the markeb)lace, not in terms of grower profits. This coat
would be weighed against public health effects of the pestidde in question. An in-
crease in the overall price of dtrus of $26 million per ^ear would cost the American
public about 10 cents per person per year, not accounting for the ability of imported
dtrus to pick up the slack.
Under the current standard, in this scenario, pestiddes that present a greater
than neeligible riak to the public are not likely to be allowed in food because the
increasM costs to consumers would hardly be noticeable. But if EPA is required to
consider the economic benefits to the dtrua growers, it could end up allowing use
of a pestidde which it would otherwise not have permitted on health grounds. 'The
pubhc would bear the health risks; the producers would reap the economic benefits.
Thaf s why growers and the pestidde industiy want the standard changed.
The NAS report spedficallv criticized the practice of establishing tolerances which
are not based prindpally on nealth considerations. According to report:
Tolerances constitute the only tool the EPA has under the law for control-
ling pestidde residues in food. To ensure that infants and children are not
exposed to unsafe levels of pesticide residues, the committee recommends that
EPA modify its decision' making process for setting tolerances so thai it is
based mere on health considerations than on agricultural practices. (NAS,
Pesticides in the Diets of Infants and Children, page 8. Emphasis in the
original,)
In requiring the EPA to consider regional growers' ability to produce crops, H.R.
1627 takes policy in exactly the opposite direction from that recommended by iha
NAS report. Superimposing consideration of benefits to growers will further oilute
the abihty of toleranceB to protect infants and children,
H.R. 1627 weakens current standards for pesticides in processed food. Current Sec-
tion 409 tolerances allow no consideration of benefits, simply requiring that the food
additive in question (in this case, concentrating pesticide residues in processed
foods) be safe. This haa been interpreted in case law to mean that there is a "rea-
sonable certain^ of no harm" from the addition of the additive to the food supply.
H.R. 1627 throws this standard out the window and replaces it with the much
weaker risk/benefit standard described above.
H.R. 1627 weakens current standards for non-carcin^ens in ^ods. Much of the
legislative debate about pestiddes has centered on the Delaney Clause and cardno-
genic pestiddes in food, but children's exposure to non-cardnoRens, particularly
neurotoxins, received considerable attention in the NAS report, H.R. 1627 would
woiken standards for these pestiddes in food.
For the several hundred pestiddes that do not cause cancer in animal studies, the
EPA sets standards that in theory provide absolute protection from these health ^-
DigmzcteyGoOgle
155
counter in the supermarket. Conducted in late Januaiy 1996, the
1(ey findings of tms poll were that 84 percent of Americans would
be willing to pay an extra $2 per year per family memb^ for gro>
ceriea to reduce pesticide use. This would result in appnnimately
$500 million in new funding to help farmers reduce their use <n
pesticides and fertilizers.
Ninety percent of Americans would be willing to pa^ at least an
extra 60 centaper ^ear per family member for grocenes to reduce
pesticide use. Tnis is equivalent to $126 million in additional reve-
nues.
It should come as no surprise that an overwhelming percentage
of consumers are willing to pay slightly more at the checkout line
if they could receive food grown with fewer pesticides. Years of poll-
ing by both industry and consumer groups alike show that consimi-
ers' views of pesticide residues have t>een consistent.
What is surprising is the extent to which the proposed legisla-
tion, H.R. 1627, is out of touch with this consumer viewpoint. The
Food Quality Protection Act is legislation that is headed in the
■wrong direction. H.R. 1627 will likely increase the presence of toxic
pesticide residues in the food supply. It ignores the fact that con-
ventional testing protocols cannot always identify long-term health
risk associated with pesticide use while studies can always be pro-
duced that show short-term economic loss, whether real or imag-
ined.
H.R. 1627 puts the health of companies before the health of chU-
dren. The bill weakens consumer protection standards throughout
the Federal Food, Drug and Cosmetic Act sections addressing pes-
ticide residues. In the name of improving safe^, the legislation re-
peals needed consumer protections without filling any of the gaps
in the existing statutes. For example, H.R. 1627 truly contains the
exception that swallows the rule.
The bill adopts a negligible risk standard but then it provides a
number of opportunities tor overriding that standard. For example,
me negligible risk standard can be avoided where "the availabuity
n vSf^*''^^^ would enable domestic growers to maintain the
arailabiUty of an adequate, wholesome or economical food supply
Ux consumers. This provision alone is so broad that it will likely
permit unfettered use of hazaixlous chemicals and put the brakes
""-iSff?^ ^^ development of safer pesticides.
The bill also repeals the Delaney CUuse, which represents the
OT^ tiiily pubhc health based standard for pesticide tolerance set-
3^°,!f^iP^^V*°.^** S'lPPort a rigorous and conservative appli-
S?^,?/^ negligible risk ^darJ for cancer-causing chemicals
S J?^™J "Vi^t be coupled with needed new protections against
^KR'^h^^^ ^^^^^^ that the following^amendments would
SSi^"H.R nn ' °^«™"« ^d these are the amendments con-
CongTMs should reaui«> thp FPA to set tolerances at levels that
cSis?»h™?j*= benefit of the doubt. . t,
154
_-Jia, ha or ihs will be abls to make th«t choice. Currently, thit inbr- nj
mation ie unavwlable to conBumen. l.
Second, the peetidde right-to-know pravinon in H.R 1771 will give food producen V
an incentive not to use known or probable carcinogena. This infonnation-bued, iton- f]
resulatory approach ahould put a premium on uoda which have not been treited P
with theae ehemicala, atimulating ttie development of alternative pest managemgit I
techniquea and rewarding farmera throu^ the marketplace. !l
If it'a good public policy fin- conaumwa to have infbnnation oa a food'a nutriti<iul \
benefits, it leema equally reaaonable for people to know if cancer-causing pestiddn
were applied.
PrtverUion of Brtatt Cancer and other lUprvductioe Diaordert
As the Subcommittee knows from hearings it held during the taat session of Con-
mas, recent sdentific diaeoveriea auggest that some pestiades mimic the actiwi of
Oie hormone estrogen and may increase the risk m breast cancer. One in nine
women are at risk from breast cancer. These peaticidea may also increaae the risk
of proatate and testicular cancer and males and reduce sperm counts.
While H.R. 1627 fails to specifically address this important problem, H.R. 1771
requires EPA to make a speafic written finding as to whether a pesticide tolerance
is Veaaonatdy antidpated to cause breast cancer or serious reproduclivfl disorders.
If a pesticide fails this test, then EPA may not preaeribe a tolerance.
If Congreaa does not see fit to phase out this class of pesticides altogether, this
provision in H.R. 1771 is a reasonable policy to impose to reduce public expoeure
to estrogenic chemicals.
In condusioii, we ui«e the Committee not to roll back consumer protections from
pesticides on food. If Congress takes that step, we urae you to at least adopt the
minimal consumer protection provisions embodied in H.R. 1771. Thank you again,
Mr. Chairman, for the opportuni^ to testify.
Mr. Burr [presiding]. Thank you, Mr. Hopkins.
Ms. DeWaia.
STATEMENT OF CAROLINE SMITH DeWAAL
Ms. DeWaal. Good afternoon. My name is Caroline Smith
DeWaal. I am Director of Food Safety for the Center for Science in
the Public Interest. We are supported by over 750,000 consumers
who are particularly interested in nutrition emd food safety issues.
Americans spend more than $17 billion a year on pesticides and
chemical fertilizers to grow their cops and to control pests and
weeds in homes, gardens and businesses. While pesticides and fer-
tilizers help deliver an abundant and inexpensive food supply and
control weeds and pests, the environmental and health problems
caused by the use of pesticides alone are estimated to reach $8 bil-
lion per year. These chemicals affect water qufdity, food safety,
farmworker safety and wildlife habitats. Production of pesticides
and fertilizer use would minimize and in some cases eliminate
these costs to society.
Consumers' concerns about pesticide use are well documented.
Year after year, opinion polls tell us that consumers don't like
chemical residues in their food. Since X989, the Food Marketing In-
stitute which is made up of food retailers and wholesalers, conducts
a trend survey eveiy year and consumers have consistently told
them that they rank pesticide residues as one of their top food safe-
ty concerns. In their latest survey that was released just this
month, nearly 3 out of 4 of the respondents ranked pesticide resi-
dues in food as a serious hazard.
In a national opinion poll conducted for the Center for Science
in the Public Interest last January, consumers showed strong sup-
port for iiinding farming methods that reduced pesticide use over-
all, even if it meant that they had to pay more at the checkout
icdV-^OOgle
counter in the supermarket. Conducted in late Januaiy 1996, the
ley findings of tms poll were that 84 percent of Americans would
be willing to pay an extra $2 per year per family member for gro>
ceriea to reduce pesticide use. This would result in approximately
fSOO million in new funding to help fanners reduce their use of
pesticides and fertilizers.
Ninety percent of Americans would be willing to pay at least an
extra 60 cents per year i>er family member for grocenes to reduce
pesticide use. TiuB is equivalent to $126 million in additional reve-
nues.
It should come as no surprise that an overwhelmine percentage
iS consumers are willing to pay slightly more at the checkout line
f they could receive food grown wim fewer pesticides. Years of poli-
ng by both industry and consumer groups alike show that consum-
!rs' views of pesticide residues have been consistent.
What is surprising is the extent to which the proposed tegisla-
jon, H.R 1627, is out of touch with this consumer viewpoint. The
?ood Quality Protection Act is legislation that is headed in the
wrong direction. H.R. 1627 will likely increase the presence of toxic
pesticide residues in the food supply. It i^orea the fact that con-
ventional testing protocols cannot always identify lone-term health
dsk associated with pesticide use while studies can always be pro-
luced that show short-term economic loss, whether real or imag-
■ned.
H.R. 1627 puts the health of companies before the health of chil-
iren. The bill weakens consumer protection standards throughout
the Federal Food, Drug and Cosmetic Act sections addressing pes-
ticide residues. In the name of improving safety, the legislation re-
peals needed consumer protections without filling any of the gaps
in the existing statutes. Tor example, H.R. 1627 truly contains the
exception tiiat swallows the rule.
Ilie bill adopts a negligible risk standard but then it provides a
number of opportunities for overriding that standard. For example,
the negligible risk standard can be avoided where '^he availability
yl the pesticide would enable domestic growers to maintain the
ivailabUity of an adequate, wholesome or economical food supply
Or consumers." This provision alone is so broad that it will likely
>^7nit unfettered use of hazardous chemicals and put the brakes
Q research and development of safer pesticides.
The bill also repeals the Delaney Clause, which represents the
tkly truly public health based standard for pestidde tolerance set*
ing.
^though CSPI would support a rigorous and conservative appli-
ation of the ne^igible risk standard for cancer-causing chemicals,
be standard miut be coupled with needed new protections against
ther hazards. We believe that the following amendments would
ciake H.R. 1627 less onerous and these are the amendments con-
ained in H.R. 1771.
Congress should require the EPA to set tolerances at levels that
irotect children and, please, where we dont have perfect science,
et*B give the kids the benefit of the doubt.
Congress should prohibit the EPA from approvine pesticides that
nay cause cancer, including breast cancer, and phaseout the use
f highly toxic chemicals.
DigilizcdbyGoOgle
166
Congreu ihould alio mandate the labeling of crops containing
poKsible carcinogenic residues. This will give consumers the free-
dom of choice at the supermarket.
In closing, CSPI urges this committee to r^ect H.R. 1627 unleu
it is substantially revised. The annual costs of pesticide use are
enormous and consumers have repeatedly expressed their pref-
erence that fewer chemicals be used to grow their food. Yet tbie
legislation is headed down the road toward unfettered pesticide
use. Increasing the use of pesticides coupled with fewer conaumer
safeguards like the Delaney Clause will undoubtedly prove even
more costly in the long run.
Thank you.
[The prepared statement of Caroline Smith DeWaal follows:]
DmtODUcnON
Amsrican faimers, homeovmen, munidpalitieB and othen apand more than tl7
bilUon a VMU- on pMticidM and chemical fertiliierf to grow thor cr^it, and cootnl
paata ana weada in hcnnea, gardens and buaineiaea. While peatiddea and feitHittn
ndp deliver an abundant and inexpenaive food supplv and control weeda and poti,
the environmental and health pronlema cauaed t^ uie use of peatiddea alont m
eatimated to reach $8 billion per year. Theae chemicals impact water quality, find
■afely, fann worker safety, and wildlife habitata. Seduction of pesticide and in-
tilizer use would minimixe and, in some instances, eliminate theae coats to sodtQ.
Consumers' concerns about pestidde use are well documented. Year after 'rur,
opinion poll* tell ua that eonaumers don't like chemical renduea in their fboduu
the risk these residues poae to their health and tlieir (amiliea. Conaumen vie*
these risks as involuntary, as it is often difScult or ei^enaive for consumers to svcid
chemicals added to the food supply. Since 1989, in the Food Marketing Institute
Treiida Survev. consumers have coiuiatently ranked pestidde residues as one rf
their top fooo safe^ concerns.' In tlieir latest survey, released just this mooth.
nearly tnree out of tour respondents ranked pestidde residues in food as a "seriooi
In a national opinion poll conducted for the Center for Sdence in t^ Public Inter
est (CSPI) last January, consumera showed strong support for fbadins faimii
methods that reduced pestidde use overall, even if this meant they had to pi; •
little more mon^ at tne supermarket checkout line. Conducted over two d^ a
late January 1996, the key findings of the poll were:
• 76 percent of Americans support levying a small charge on agricultural use ii "l
pestiddes as a way of funding sustainable agriculture.
■ 86 percent of Americans think Tederal and state agriculture agencies should ttscfi
fanners how to use fewer pestiddes.
Even if pestidde and fertilizer taxes resulted in increased fbod costs to consum*'*
the poll dnnonstrated strong support:
• 84 percent of Americans would be willins to pay an extra $2 per ;sp«arjper funill
member for groceries to reduce peetidde use. This would result in $600 miUUv
that could be used to help farmers and others reduce their use of pestiddes ai
fertilizers.
• 90 percent of Americans would be willing to pay at least an extra $.50 per Jf
per fiunily member for groceries to reduce pMtidde use; this is equivalent ^
$126 million in additional revenue,
Whv are consumers so motivated to get pestiddes out of their food that ttxT
woula pajT more for the food itself? Four decades of carte-blanche use of pesliddM
and feiiilizers has taken a seriouB toU on fanners' health, water quality, food sstM}!
and fish and wildlife habitat in the United States.
The potentia] "side effects" of heavy chemical use for both agriculttu-sl and non-
a(^eultural uses were not adequately recognized fivm the onset, Althou^ senril
scientists raised questions about the potential harm posed by unfettered use of p«e-
DigilizcdbyGoOgle
■ oftan illwiilwiil u liTitorical* resctioiu to tfae new
wave of t«chnolosv ijnnbciliud by Duponf* corponte slogan— "Betto- living
Throui^ ChemistiT!^
" "t „ .„ , , ,
B extensive use tS pestiddei and fertiliien. These estimates
cnBoing, and in some eases the fiUl extent ti the damage will not be known for
jean. What is clear, however, is that this national problem is enormous, multi-fac-
eted, and will require subetantial changes in &nning practices and consumer habits
to enedavdy reduce fliture damage.
Only in the past 20 years have reMarchere begun to identify and quantify the
damage caused by the — ' — ' ' — "-^ ' -— ^.^ r™.___ __^__.__
HEADED THE WfiONO DIRECTION: CONOREHS AND PESnCIDE R
It ahould come aa no aurprise that an cxverwhelmine percentage of consumerv are
willing to pay sli^tly more at the checkout line if uiey could receive food grown
using fewer pesticides. And years of polling by industrv and consumer «oup> alike
show that consumere' views on peetiade rendues have Men consistent. What is sur-
piiaing la the extent to which the propoaed legislation, HR 1627, is out-of-touch with
this consumer viewpoint
The Food Quali^ Protection Act, HR 1627, is legislation that is headed the wrong
direction. HR l^Twill likely increase the presence of toxic pesticide residues in the
ibod supply. It ignorss the fact that conventional testing protocols cannot always
identify long-twm health risks associated with peetidde use, irtiile studies can al-
wm be produced to show short-tenn econranic loes, whetho- real or imagined. HR
1627 puta the health of corporatiims before the besltn of diildren.
While there ia strong support for basing pesticide tolnaneas on the best science
eveilaUe, there are inevitable gaps in Qie scientific basis fbr regulating theee chemi-
cals, particularly with reepect to long term human health effects. Where theee gape
exist, the benefit of the doubt ahould be in fkvor of protecting public health rather
than protecting industry profits. But this ia not the approach adopted in HR 1627.
The bill weuens consumer protection standards throughout the Federal Pood,
Drug and Cosmetic Acf • tections addrMalng pesticide reeioiies in food. In the name
(rf improving aafe^, the legislation repeals needed consumer protections without flU-
ing ai^ of tne gaps in the existing statutes. For example, the new definition of pes-
tidde diemlMls contained in the l^ialation restricts r^ulation to active pratidde
ingredient
ticm Agent
asbestos fl , ,__, . __,
can be found in much greater concoitratlons than the active ingredients in pes-
ticides, and may represent a significant contributor to dietsiy vcpoeure to toxic
chemicals.' New language in the bill would limit tiie BPAa ovwsi^t over these
diemical agents, ana could result in increesed dietary exposure to the most toxic
inert inneoUents in pestiddes.
HR 1627 truly ccmtains the exception that swaUows the rule. The biU adopts a
"negligible rlslr standard, but then it provides a number of opportunities for over-
ridiiig this standard. For example, the "ne^igible risk" standard can be avoided
where the availability of the pestidde would enable domestic growers to maintain
the avaUaUlit^ of an edetjuate, wholesome or economical food supply for consum-
ers." Hue provision alone ia so broad that it will likely permit unfett«i«d use of haz-
ardous diemicals and put the brakes on research and development of aafer pes-
ticides.
Even when the a^cy does apply the "ne^lgible risk' standard, HR 1627 goes
a step beyond what la generally considered appropriate from a public health stand-
point hv applying "nwugible-riBk' standard to all typee d haiards aasodated with
peetidde use, not juat to cancer-cauaing chemicals. As generally understood, the
negligible risk" standard would allow adverse efiects to occur at a frequency of one
in one million c ases.
Thua, instead cS requiting the EPA to detennine the threshold level of a chemical
residue that is likely to cause birth defects or neurotoxic effects and eetting a stand-
ard that is suffidentiy below that threahold to assure the protection of tba public,
the It^^ation would allow tx these adverse eCfocts in a small number of eases. HR
1627 will put the government in the business rf setting the pennissible number of
birth defects or neurotoxic effects that would be alloweo frtan ug^ use of pestiddes,
thus condemning individuals and Cunilies to lifetime disabili^ wid costs.
The bill also repeals the Delaney dause. which bans the concentration of cancer-
causing peetiddee in proceesed fooda. Tlte Delaney clause represents the only tnily
DigilizcdbyGoOgle
158
puUie bMlth-bued atandard fiv pestidde tidanum ■--_— -
nipport A ngoroiu and conaarvatiT* apidieatioa at tha "na^fiUs tuf atandard &_
cancer-cauaitig cbamteala aa a aubatituto for tha Delaney Mn, the atandard muat ba
coupled with naadad^mw pratactioiia afainat odwr hasatda, auch aa r^>n)duclive
aU
phaainKoi
lated under me Ddanay dauae.
developmantal effiacta, neurotodc c^cta: and additional protactiona tor di^drat
. _i. ,1. — ,__. V 1_ ._ _jii.!__ — ^_!j '— '--^^ntion ahould move to-
[ developmantal eincta, neurotmc afiecta: and additional pro
n all chemical haiarda. In addition, peaticide re f b r m iMElalat
■d phaaimr out tha moat tcme peetia£ chemicala, inducfing t
HR 1627 ignoraa critical public health gapa in the preaent iTston) that have bean
identified by the National Academy of Sdencea and oOiarai
• HR 1627 fkila to mandate the implementation ot any additional protectitaia for
children that were raoommendea by the National Academy of Sdencea* report,
PittideU* in tht Ditt* of Infant* and Children.
• HR 1627 bila to addreaa the problema of multiple routea tS peetidde coqMaure,
auch aa fix>m fi>od, water, garden and home applicationa.
• HR 1627 faila to addreaa the &ct that our diet, mdeed many individual finda, ac-
tually contain multiple peatidde reaiduaai nor doaa it make any proviaicm for
■"■"■■ "-"g toxidty raaulting fiom intermctlcm betwem difbrent diamical agenta.
"Hie bill alao doaa nothing to promote altemativea to agrichtmical uae. Peatidde
use reduction techniques would clearly decrease the health and environmental eoata
diaeuaaed above, but they wont be aiu^ted until &rmars are aaaured that the tech-
niques will won- Heaaarch and development is needed to aaaure tliat theae tech-
niques are effisctive in reducing peatidde uae without harming Euroing productivi^.
We believe that farmers want to reduce the amount of chonicala thm naa to grow
our food, both for food aafety reasons and because these chemicals effect their own
health. They need some training, however, in how to do it auccaaafblly.
Althou^ the Center for Science in the Public Interest opposes HR 1627, we be-
lieve that the fallowing amendments would make the bill lesa oneroua:
1. Congrw ihould rtquirt the SPA to mt tolerance* at Inwb that protect ddidren.
The National Acadony of Sdencea' (NAS) 1993 report on peaticids tolttwioaa and
children documented that tolerance setting practices do not adequaldy protect chil-
dren from the hannftil etbcts of peatidde realduea. The NAS made a aanea <rf no-
ommendationa to cmrect this dAdency. We support an amendmuit ihaX would
mandate implementation ti the NAS recommendations to better protect our diildreo
from harmful efllBCts of peatidde residues. Where we dont have perflaet adeoee, let^s
give kids the benefit of the doubt
2. CoT»grea* ihould prohibit the EPA from approving pettiddee that may oousf con-
Cancer continuea to be a leading cauae of death, and many studiea have docu-
mented the linka between the uss ot pestkidea and increases ui cancers.* One form
of cancw, breast cancer, has become a growing proUon fbr American woman. Since
1960, the riak of braaat cancer more than douUed, from one in twen^ to one in
nine. Only about 30% of the victims have known risk Cutors, such as a lata first
pregnannr, limited breast-Cseding, or a Cunily hiatoiy of the conditicm.' Many ad-
entuta atlribute the increaae in thaea cancers in part to the more frequent use of
very patent chemicals which mimic the hormone eatroeen in the bo<^. Tbema chemi-
cals are aometimea fbund in pestiddea. Some, like DDT, have alrea^ been banned.
Tha EPA ahould be given a mandate to assure that, where chemicals are fbund to
be a contributing Ikccor to the devdopment of breast or other cancera, theae chemi-
cals should never reach the market
3. Congreet ghould mandate the labeling of crop* containing poaaible carcinogen ren-
in opinion poll after opinion poll, consumerB expreoa concerns about pestiddea in
their lood. Part of this concern deariy arises frcnn the fact that consumers arent
infbrmed about the chemicala that are used. They arent given the inf<»inatlon that
would allow them to select food with low riak peatiddes over thoae containing more
toziGonea.
ffith the more permisdve use of cancer-cauaing chemicals authorised by HR 1627,
consumer eonfldsnce in the safety of fruits and vegetables will only be weakened.
Given the tremendous nutritional beneSts of fruits and v^cetablea, Congreaa ahould
e AbnanuUtMs, Cancer,' CfMmidat and
DigilizcdbyGoOgle
act to •limiiiata the tfisbiwt that lad at infbnnation about chemical inputa creates.
Pood that ii treated with cancer-cauaiiw pesticidea abould be clearly labeled to per-
mit Breater eonnimw chtrice in the mai^.
T_ .iui__ nam ..— i-ki. ____'
In cloaing, CSPI urgaa Uiis committee to rqect HR 1627. Aa our recent report.
Funding SMtr farming, clearly doeumenta, the annual coata of peatidde uae are
enormous. Oonsumers recopiiae these coata, and have repeatedly expressed their
p r e fer e n ce that fewer chemicala be used to grow their fiioa. Yet, tiiis legislation is
beaded dewn ll» road toward unfettered pesticide use. Increasing the use of pes-
ticides, coupled with fewer consumer safqcuards, will undoubtedly prove even more
coatljr in the long run.
Mr. Burr. Thank you, Ms. DeWaal and thank you to the rest of
our witnesses who fire here to testify today and for the committee,
if it hadn't been known, we had a late night last nieht. If we look
a little bleary-eyed up here, and many have multiple hearings
today so if you hear us talk about Clean Air, we are just — we have
got the wrong panel in mind, but bear with us.
I am also told that we have about 40 minutes before we can ex-
pect the next vote so we will do everything we can to make sure
that we move through it aa quickly as we can to cherish your time
and we appreciate you being here.
At this time I would like to turn the questioning over to the
ranking minority member, Mr. Waxman.
Mr. WAXMAN. Thank you very much, Mr. Chairman. I want to
thank this panel for your excellent testimony and particularly Mr.
and Mrs. Chuda and Mr. Eichler for traveling a long distance to
be with us today.
One of my greatest concerns is to ensure that whatever pesticide
legislation we do enact be based on the best possible science. I
know this is a concern shared by many members of this sub-
committee because many of my colleagues nave emphasized the im>
portance of sound science in talking about pesticide or any other
environmental legislation.
Dr. Landrigan, you were the Chair of the National Academy of
Sciences panel that examined the risks of pesticides to children.
The NAS issued a comprehensive report in 1993 with important
recommendations about now to improve regulation of pesticides.
Can you tell us whether H.R. 1627 ia consistent with the rec-
ommendations of the National Academy of Sciences?
Mr. Landrigan. Sir, H.R. 1627 is consistent with a few of our
recommendations. I mentioned in my verbal testimony the provi-
sions for increased surveillance are good, but in my opinion it falls
short when it comes to the main recommendation.
The central recommendation of our report from the National
Academy of Sciences was that tolerances for pesticide residues in
fooids must be set at levels that are low enough to protect children
from disease — ^unequivocal in the way we expressed that — and my
concern ia that the provisions of H.R. 1627 will enable children to
be exposed to levels of pesticide residues in foods that will increase
risk of disease, that wUl increase risk of cancer, reproductive dys-
function, possibly of immune dysfunction and possible of future
neurologic dysfunction and this is something that I just don't think
that we should tolerate, sir.
Mr. Waxman. The bill, H.R. 1627, does not have that provision.
I introduced a separate bill, and Section 3 of that bill would require
EPA to determine whether pesticides are reasonably emticipated to
harm children before issuing a tolerance which would allow them
DigilizcdbyGoOgle
100
to be uaed. It also uyt that in makbiK thU determination EPA
muat Implement the recommendationi at the National Acadrany a!
Sciences.
!■ thig provision the kind of improvement in our pesticide lam
that the NAS recommended?
Mr. Landriqan. Yes, sir, exactly, and I commend you for bavin;
written that in H.R. 1771.
Mr. Waxman. Dr. Reisart, you have emphasized the importance
of health-based standanu for regulating pesticide exposure in food
H.R. 1627 does not appear to have a hralth-based standard became
it expressly allows a greater than nef^igible risk if EPA determiiKj
that such greater risk is outweighed by economic benefits to grow-
ers. This is a cost benefit standard, not a health standard.
Does the National Academy of Pediatrics support or oppose tbe
approach of H.R. 1627?
Mr. Reigabt. This approach clearly does not meet our critott
As I said in my prepared testimony, the principle of *%3t, do do
harm," that is, first show that a pestidde is safe for children bdint
looking at the potential benefit firom it, is the basic medical ap-
proach and has been supported throughout by the Academy of Pe-
diatrics.
H.R. 1627 actually has an enormous loophole in allowing greater
than negligible risk under very broad terms and this is clearly not
consistent with the desires of the Academy of Pediatrics.
Mr. Waxman. In contrast, our bill, H.R. 1771, would have a
standard that would say that pesticides be reasonably anticipated
not to harm children, and it would prevent the issuance of a toler-
ance expected to have this efTect.
Does the Nationsil Academy of Pediatrics endorse H.R. 1771?
Mr. Reigart. Well, actually the Academy would probably Uk
you to go a little further in requiring that they be demonstrated to
be safe for children rather than a reasonable expectation of no
harm, but certainly it is a lot closer to our desires tnan H.R. 1627,
Mr. Waxman. At the least, we ought to say that we shouldn't
allow
Mr. Reigart, At the very least
Mr. Waxman. [continuing] pesticide where we have a reasonable
anticipation that it is going to harm kids?
Mr. Reigart. That's correct.
Mr. Waxman. Okay.
Mr. Reigart. As I said, it goes a long ways but it isn't even as
far as we would probably prefer.
Mr. Waxman. Dr. Wolff, I want to switch from discussing M-
dren to discussing breast cancer and reproductive disorders.
Are there sound scientific reasons for being concerned that pes-
ticide exposure may increase risk of breast cancer and reproductive
disorders?
Ms. Wolff. There seems to be more and more evidence in the
direction.
Mr. Waxman. And you have told us that there is evidence that-
that there is a causal relationship. In light of this evidence does it
make sense to adopt a provision like Section 4 in H.R. 1771 whidi
requires EPA to assess the likelihood that pesticide exposure will
contribute to breast cancer and reproductive disorders?
DigilizcdbyGoOgle
Wolff. I think it is incumbent upon u< to do that.
Waxhan. Thank you very much. Thank you, Mr. Chairman.
Burr. I thank the gentleman. The Chair woiild recognize Dr.
n.
COBURN. Thank you, Mr. Chairman, and I thank each of you
ing here.
B Member of Congreii and also as a phyiician, one of our
«t difficulties is to match science with reasoned thought and
1 what we see from the scientific community versus what we
nn the broader picture as well.
[ listened to the testimony I just had a few questions that
•f all I would like to ask of the physicians on the panel, if I
, and then maybe move from there.
Wolff, you mention the association of certain pesticides with
aed incidence, potentially an increased incidence, of breast
* possibly through its offsetting or anti-andrc^n effects, but
ere in fact other studies that show that there is not a correla-
br example like DDT?
Wolff. I'm not a physician, but can I answer that question
'&
JOBURN. Yes, you can.
Wolff. I think you are referring to the most recent study
iras published that did not in a statistically significant sense
rt or confirm the earlier findings,
re are a lot of research investigations underway now that I
will help us understand that a little bit better find, strictly
ing, that certainly is so
COBURN. Is there a particular reason why you didnt mention
rtudy in your testimony, that you referenced studies that
td that position but didnx reference
Wolff. I think I did mention — I think I mentioned them all.
COBiniN. You mentioned the study in "Public Health and Ep-
ology Reports of Ontario," August 25, 1994? Is that referenced
Lr testimony?
Wolff. In my testimony I mentioned the three studies that
onall^ have been involved in, one of which did not show sta-
illy significant confirmation of the earlier two studies that I
nvolved in. A number of other people in the scientific lit-
re have said that they felt that that study actually was vety
rtive of the earlier findings even though it didn't meet statis-
lignificance.
hat the one you were talking about?
COBURN. Yes.
Wolff, Perhaps there is another that
CoBURN. Well, I am referring to one from "Public Health and
miology Reports of Ontario," Volume 5, Number 8, August 26,
whioi talks about no correlation between DDT and breast
r.
Wolff. This is a scientific study
CoBURN. Yes, it is.
Wolff, [continuing] or it's a review? Perhaps it's a review
earlier studies.
COBURN. Well, actually 111 be happy to visit with you after
DigilizcdbyGoOgle
162
Mb. Wolff. Okay, okay
Mr. COBURN. I have not read the entire study, just the summaiy.
Doctors, do we in fact have prospective stucUes to tell us what
risk levels should be on children? rm talking prospective studies,
scientific studies that say this is the level at which uiere is no risk?
Mr. Landrigan. Let me answer it this way, if I may, Mr. Con-
gressman.
We undertook in our analysis a very careful and thorough re-
view — it took us 6 years to accomplish it — of how EPA and the
other regulatory agencies evaluate the toxicity of pesticides.
A miuor finding of our report is that there is a pervasive lack of
adequate testing data for pesticidea that are used in the market-
place and in particular, sir, there is a lack of data on the toxic ef-
fects of pesticides — when young organisms, young animals or young
children, are exposed to pesticides there's virtually no data on the
long-term consequences of early exposure.
Mr. CoBURN. I understand that, but that ia why I asked the
question are there
Mr. Landrigan. We're fljdng blind.
Mr. CoBiTRN. [continuing] there prospective studies ongoing
today that will help us answer these questions?
Mr. Landrigan. There are some
Mr. COBURN. Should we repeat asbestos all over again in this
country and the costs associated with that, going on the false sup-
position that we had a marked increase in risk when in fact the
science now shows that we increased the risk by doing what we did
on asbestos?
What I want to do is trust your medical opinion but I want to
find out are we doing the science to make the decisions? Are the
scientific studies being done on pesticides right now prospectively
on exposure to children by weight and body through time that we
are going to find out the answer to these questions, or are we just
going to oan the pesticides and say they might?
Mr. Landrigan. Well, the asbestos was an absolute disaster. I
am from Mount Sinai Medical Center and my predecessor at Mount
Sinai was Professor Irving Selikoff, who was the man who estab-
lished the link between asbestos and cancer and by the time the
asbestos epidemic plays out in this country 25 yeeirs from now into
the next century, there will have been over 300,000 deaths from as-
bestos. We most certziinly do not wish to repeat that tragedy.
Mr. COBURN. And we will have increased significantly me num-
ber of people that are going to die from it by removing it.
Mr. Landrigan. Well, that's a whole other debate.
Mr. CoBURN. Ill be happy to debate that one with you, too, but
let's stay with this.
Mr. Landrigan. Okay. Well, in the case of pesticides, the basic
situation that we are in is that most of the pesticides to which our
children are being exposed have not been adequately tested. This
is a national scandal and we said that in the report from the Na-
tional Academy.
Mr. COBURN. But I still haven't gotten an answer from you.
Are there ongoing prospective studies for these pesticides?
Mr. Landrigan. For the most part not, sir.
.dV^^oogle
168
Mr. COBURN. Ok^. That is the queation — bo the science is not
there now and there is no plan to get the science?
Mr. Landrigan. Well, I can't spealc for the EPA but it is my un-
derstanding that they are improving their testa, but at the present
time we are letting pesticides on the market, inadequately tested,
and we are hoping that they don't cause damage to kids, but we
are not testing them. We are failing in our primary reaponaibility
as physicians to do no harm.
Mr. CoBURN. Thank you.
Mr. Burr. The gentleman's time has expired and we will try to
go back through for another series of questions for those who have
additional questions.
"The Chair would recognize Mr. Stupak.
Mr. Stupak. Thank you, Dr. Landrigan.
I am looking at page 7 of your testimony and you said, correct
me if I am wrong, where it is underlined on Delaney Clause, you
would be willing to replace the Delaney Clause if it were replaced
by language directing the Federal agencies to employ state-of-the-
art science to prove clear protection for America's children against
Uadc pesticidea.
Mr. Landrigan. Yes, air.
Mr. Stupak. Could you elaborate on that a little bit more, what
you would like to see, if Delaney was repealed on that?
Mr. Landrigan. Well, back to first principles. The first thing I
would like to see is children protected from unnecessary exposure
to toxic pesticidea and I would like to see them protected finm the
disease that I deeply fear will result from that expo8u.Te. That is
the goal.
So then it becomes a question of ways and means.
As far as Delaney is concerned, Delaney is not perfect. A lot of
people don't like Delaney because it draws a bright line, it ia black*
ana-white, it allows no wiggle room, it allows no discretion. And
some of my colleagues in the risk assessment community have ar-
gued that Delaney ought to be replaced by something that allows
consideration of different pesticides. We know that all pesticides
are not equal, we know that some are more toxic than others and
some would like to aee Delaney removed and replaced by aomething
that would allow the regulatory agencies to take cognizance of
those differences, all well and good.
llie problem with the proposal that is made in H.R. 1627 is that
it would quietly do away with Delaney and replace it with a rule
of law which is so loose, which has been so el^antly described by
Mb. DeWaal, that it would allow, probably, increased use of toxic
pesticides and further erosion of the protections that currently
exist under Delaney. Delaney is not all bad; it has done a good jcn
for nearly 4 decades. We should not diacard it lif^tly.
Mr. Stupak. Whatever language is agreed upon, whether it is re-
taining Delaney or language to provide the state of our science,
should also include adults, too, right? I mean, the purpose here is
not just children, you know, as has been the emphasis here today
but also to adults also. But there would be different models or dif-
ferent standards you would use for adults as opposed to children,
correct?
DigilizcdbyGoOgle
164
Mr. Landrigan. That is correct. I think the emphasis on children
is well placed, though, for the simple reason that children, in most
cases, are the most vulnerable members of our society and so if we
are able to write legislation and regulation that protects children,
then per force we will protect everyone else.
Mr. Stupak. Okay, but I am going back to Mb. Chuda'i testi-
mony then. How do we protect those type of situations if our em-
phasis is on children? You see the area I am having trouble with
there?
How do we provide protection — ^I wouldn't want the language —
the proposed language is to deal with children but how do we pro-
tect women in cmld-Searing years or how do we do that? We would
have to have a different model to do that, right?
Mr. Landrigan. There is some good language in the Clean Air
Act. The Clean Air Act talks about setting standards such that
they protect the most vulnerable members of our society and I
think that maybe that is the blanket rule that you are reaching for.
Mr. Stupak. Thank you. I have no further questions.
Mr. Burr. The gentleman's time has expired.
The Chair would recognize Dr. Ganske.
Mr. Ganskb. Thank you.
I want to express my sympathy to the Chudaa for the tragedy
that they have gone through. I have treated children with \^m%
tumor and In dealing with the death of a child, there is just no ade-
quate answer. And I appreciate your being here.
Part of the difficulty of being a legislator is that you are torn by
testimony such as yours and it elicits a great deal of sympathy
from all of US, believe me. And yet, when we set into the realm of
legislation, I think that in addition to sympatny, what we need is
wisdom in deciding how to handle some (^ these problems ba:ause
what may be sympathetic on an individual basis may not be wise
overall and what may be sympathetic to one group may not be
sympathetic to another group that Is affected and so that is why
these are difficult things.
I guess I would like to say that I think there is obviously no
doubt that chemicals can cause cancer. I mean, all you have to do
is open the sports ^age and look at what has happened with Mick-
ey Mantle and the ingestion of ethanol or I remember from medical
school reading epidemiologic studies about how people in southeast
Asia inject or eat large quantities of pickled foods and get esopha-
geal cancer from that and it was just the other night that I was
eating a big steak that had a large amount of charring on the out-
side and I must admit the thought went through my mind, gee, I
wonder if I am setting myself up with this barbecued steak for
stomach cancer.
So clearly, you know, there are things to worry about but I guess
we have to do something with common sense here too because, you
know, would we recommend on the basis of those three examples
that we never drink liquor, that we never eat a pickle, that we
never barbecue? And the answer, of course, is no because there has
to be some bedandng in there and the other part of the reason is
that there la definitely something related to dose relationships to
risk.
^dVL^oogle
166
And BO I guesa that brings me around to a question fbr Dr.
Reigart and tiiis gets, you know, down to I think really the Delaney
Clause and I do have some problems with that. I mean, I think.
Dr. Reigart, you probably acknowledged that one of the biggest
problems we are having with children these days is increasing —
and adults are increasing risks of melanoma related to sun expo-
sure; is that correct?
Mr. Reigart. Certainly that is true, yes.
Mr. Ganske. And so what do we do? All of us we recommend
that we apply a lot of sun screen to our children early so that they
can avoid the two or three or four episodes of bad sun bum that
probably — early in life that predispose them to later melanoma,
right?
Mr. Reigabt. And we recommend keeping them out of the sun
to protect them from exposure.
Mr. Ganske. And at the same time though we recognize that
playing outside is healthy, that getting some sun exposure is prob-
ably useful in terms of vitamin D and we certainly want them to
grow up strong, healthy bodies, the whole thing, right?
Mr. Reigabt. Yes, air.
Mr. Ganske. So we are applying some common sense to this, oth-
erwise what we would do is we would keep our diildren inside all
of the time and keep them totally covered up; is that right?
Mr. Reigart. That is correct.
Mr. Ganske. If we were dealing with only — a zero risk goal.
Would you agree with that?
Mr. Reigart. Yes.
Mr. Ganske. It seems to me that there is some consensus on the
panel that we need to move in some direction away irom a zero
risk assessment.
Mr. Reigabt. I probably could sidestep the length of the question
by saying the Academy has supported a true negligible risk stand-
ard to replace the Delaney Clause and I have testified to that effect
in the last Congress. But it needs to be a true health-based n^-
ligible risk without exceptions.
Mr. Ganske. And I appreciate everybody's testimony today be-
cause we are going to try to — ^we are looking at that.
I would like to point out in the limited amount of time that I
have here that I do think that the EPA, as much as they are ma-
ligned sometimes, has been trying to, has been factoring in child-
hood testing because when they look at exposures to t<mci^ and
calculate that over lifetimes, they are starting with childhood and
going all the way through end then calculating a risk in parts per
million over a 70-year life span; is that not correct?
Mr. Reigabt. They have done a limited amount of those kinds of
calculations, yes, sir. But according to both our assessment and the
NAS panel, it is insufficient testing.
Mr. Ganske. And I would also certainly agree that it would be
useful to, with Dr. Cobum, that it would be usefiil to have better
prospective studies in these areu and I am sure that you would
agree with that also.
Thank you.
Mr. BuBR. The genUeman'i tlm* hai Mtpi«d.
DigilizcdbyGoOgle
166
The Chair would take the opportunity to ask just a few questions
and, a^Un, to try to stay on schediUe.
Ab-. Eichler, let me sav that in your testimony you expressed con-
cern over the use of sulfur dioxide in Turkish apricota. You indi-
cated that, based on your concern, you did some research which is
admittedly more than I would probably do and most consumers,
quite honestly. And you found that sulfur was an ingredient in gun
powder, rubber vulcanization and insecticides. You are 100 percent
correct because I did my research after reading your statement.
You are also correct that some products that contain suUur and
sulfur compounds are dangerous and even fatal. However, you
seem unclear that sulfur and sulfur dioxide are two very different
substances, as different as carbon, such as pencil lead, and carbon
dioxide, which is found in forms of dry ice.
Understanding the potential dan^rs of suliiir as well as tiie dif-
ferences between elements and their compounds, I was just curious
to know if you were familiar with a product called Bactrum DS.
Are you, sir*
Mr. Eichler. No, I am not.
Mr. BUIUL This is a common antibiotic, often used in the treat-
ment of urinaiy tract infections, but it is oftien very frequently used
for the treatment of acute otitis media, commonly known as a
childhood ear infection. Bactrum DS is a sulfur-baaed antibiotic
that is readily available as a pediatric suspension at local drug
stores.
I guess my point is that the average consumer, and I would cer-
tainly include myself in that category, is not knowledgeable enough
about chemistry and the periodic tables of elements to draw rea-
sonable conclusions based upon labels such as the one that you de-
scribe from this experience possibly existing. It is and should be
the responsibiliW, I believe, of scientists such as the ones at EPA,
USDA and the NAS to determine which foods are safe for human
consumption, and to disallow marketing of those which do not meet
the appropriate standards. And, if you would, can you comment on
that for me?
Mr. Eichler. Okav. Well, first off, you know, as I have said in
ny statement, I don t come here as an expert in any form or way
and all I know is what my short readings told me. Basically, I
think you do underestimate a bit, you know, the American
consumer. I think we do have at least some knowledge and, if noth-
ing else, the point I weis drawing here was the matter of choice.
The thing is that if I see this, if I see some pesticide that is on
there, I have the choice of, selecting that food or not. And I think
that we certainly all would acquire enough knowledge about cer-
tain pesticides that that choice may be that we don't want to pur-
chase that or not.
Mr. Burr. Even if that labeling misled the consumer about the
risk or possibility of risk?
Mr. Eichler. well, you know, it is hard to say what kind of la-*
baling would mislead you. Obviously, if you went into the store '
today, I am sure that sometime ago when maybe the difference be-
tween ground beef and hamburger and ground sirloin might mis-
lead you. Possibly we could just label them all as ground oeef be-
cause that is what they actually are.
DigmzAbyGoOgle
167
Mr. Burr. In fact, dont we have agencies that are set up to take
unsafe prcklucts off the shelves?
Mr. ElCH];.ER. I really don't know. I would hope so. I would cer-
tainly hope so.
Mr. Burr. So we bftsically are not talking about unsafe products,
we are talking about the question of labeling in this particular case
where there can be a misunderstanding by the consumer based
upon the dynamics of what might be applied.
Mr. EiCHLER. Well, I certainly think that anybody could be mis-
led by an3rthing or it is possible that if you are, you could read a
label and you could misunderstand that. I agree with that; I think
that is possible.
But I think that we have to give the American public — every
year we do have a little bit more education and every year we do
nave a little bit better understanding of what is going on.
Mr. Burr. And I can assure you that we are ^ying to work with
agencies to try to make sure that they change as technology and
information gets better.
I am going to pass on the remainder of my time if I can. I really
would like to get this finished before we have to leave and as you
heard the buzzer, I am going to allow the ranking minority mem-
ber, Mr. Waxman, to follow up and then, if we can, we will take
one on this side and I think we might be able to make our vote.
Mr. Waxman. Thank you, Mr. Chairman. I know the Chudas
have to leave to catch a flight back to Los Angeles and because of
the extra security precautions, they probably need to leave right
awa^.
I just was going to ask you one question.
Doesn't it make Just common sense if we are going to have a bill
that is going to increase the amount of pesticides that will be on
food, if we have a known or probable human carcinogen, even if we
are going to allow it because we are going to have this ^isk^eneflt
evaluation, shouldn't we let the consumers know, just have that in-
formation available to them so those who want to take precautions
can avoid it, those who don't won't?
Ms. Chuda. That is all I am saying is, give us the right to know.
If I as a mother during the time wnen Colette was young would
enter the supermarket and I could browse the supermarket and
look at various products, be it household chemical type products,
the fruits or vegetables that might have contained pesticides that
were carcinogens, if these things were labeled as such, if I had a
better understanding as a mother as to what it was I was bringing
into my household, I might have avoided her cancer from occurring.
I think what we are saying here is let's work together. I under-
stand what you are up against in terms of cost/benefit but there
is no risk. If you are talkmg about the life of a child, there should
be no risk. Why can't we create a new paradigm? Why can't we put
a child in the center of that paradigm instead of a 160 pound male,
which is what most of the tolerances are based on? vAiy don't we
look at a child? Why don't we protect ourselves, all of ua?
But I think we know that the pervasive chemicals that are in our
environment are cumulative, synergistic and they are affecting the
development of children and I think we have to begin with a new
trust and that is putting children first.
DigilizcdbyGoOgle
Mr. Waxhan. Well, we have several provisionB. One is to pat
children flrat. But even if we weren't going to do that, one of the
provisions we have is people ought to nave the information. If we
are going to allow these pesticides to be used, let the people know
about it.
Mr. Chairman, I want to let anybody else ask any questions ct
the Chudas before they leave because I know they have to leave
early. Then I am going to yield to Mr. Bilbray, becatise he ou^t
to have a chance since we will probably have to break for a bunch
of votes because those Democrats are being dilatory on the floor.
Mr. BUKR. I thank the gentleman and the Chair would rea)giiize
Dr. Cobum for 1 quick second.
Mr. CoBlTKN. Mr. Chair, I would like to have permission to enter
into the record these two studies that I referred to.
Mr. Burr. Without objection.
[The reports appear at pp. 170.]
The Chair would recognize Mr. Bilbray.
Mr. Bilbray. Yes, I would say this just quickly for those of us
who are Califomians. There is this sense that you can't have over-
kill by warning. Now, we live in a State where there might have
been a good idea and I ask your dialog. Wth Proposition 65 and
the average citizen in California, they don't even react to those
warnings now, and we have reached a point where there's — and I
want to say this to our witness. There is a point to where the aver-
age mother just tunes out these WEunings, and I think we need to
make sure that there is bftlance enough to where we protect the
children, but we don't desensitize the consumer with the attitude
of whenever in doubt, let's just say it might be bad, and say it be-
cause there is nothing to lose.
What I worry about, as somebody who has seen bad things hap-
pen, from my feunily's perspective, is that I watch the average
consumer become desensitized to "wolf being cried all the time.
Wouldn't you agree that we have got to make sure that when we
do label these things, when we do raise a red flag, that we don't
run into a situation where we desensitize them? I think those of
us in Cftlifomia, we walk into any store or facility in California and
it has got a warning sign that there is cancer-causing elements
used or in this area, and do you think the consumer really sees or
reacts to those now? You are in California.
Ms. Chuda. I think you do see them. I have seen them labeled
outside of supermarkets concerning saccharin. I don't buy anything
that contains saccharin. I think it is a warning and I think it is
an important warning and I think it is something that we need. I
mean, personally, we have to have the ri^t to choose.
The second point is, where are the alternatives? Where are the
companies out there developing something other than a carcinogen
or a chemical? Where are the alternatives that could infiltrate our
marketplace, create a greater consumer demand? Because I think
the populace at large wants that. I think they want products that
don't have carcinogens. Why cant we make this country strong and
develop products that don't have
Mr. Bilbray. My question was speciHc to Proposition 65.
Ms. Chuda. Right.
DigilizcdbyGoOgle
169
Mr. BiLBRAY. Which you and I know we cannot walk into almost
any public facility, be it a restaurant, a bar, a groceiy store, a
hardware store, that we do not have those warnings. But I am s^-
ing with Proposition 65, we have been so desensitized, that when
you walk into a public facility now, you are probably desensitized
to every one of them, because there is an overkill of WEiming. That
is what I was talking about, specifically what has happened in
California with Proposition 65.
Mr. Waxman. Will the gentleman yield to me?
Mr. Chuda. There is a particular study right here that talks
about under Proposition 65, these exposures — ^we are not told what
exposures to children are under Proposition 65. We know they exist
but we don't know what products our children are exposed to.
Mr. Waxman. Mr. Bilbray, will you yield to me?
Mr. Bilbray. Yes.
Mr. Waxman. I wanted to clarify something for everybody's infor-
mation. What we would do would be to preempt Proposition 65 and
if we are going to have the underlying bill which would use more
pesticides, at least for 12 or 13 pesticides that Eire probable human
carcinogens or known human carcinogens, have the information
about those disclosed. That, I think, would have far more meaning
because we are not talking about everything being labeled, we are
talking about something for which there is a scientific basis.
Now, from my point of view, if it is a known human carcinogen,
I don't want it used at all. But if we accept the premise of this bill
that we are going to say that even though there is a risk to human
health, we are going to let it — the pesticide be used because of the
interests of the growers, let the public know about it.
Mr. Bilbray. Reclaiming my time, the fact is that the issue of
zero risk is a great goal. Everyone knows that that sounds good in
Washington at a hearing but zero risks do not exist in life, they
do not exist for you to come here to testify, for me to take my child
to school. And the fact is that what we are looking here is that
what is a reasonable, what is a reasonable level of risks based on
cost beneHt and how those things work out.
But the concept of what we are hesiring here, that any reason-
able impact at any level is not acceptable, I think those are lines
that sound good when we are here. But when we are trying to raise
our children, when we are trying to choose, to make priorities of
protecting them, we need to know what is reasonable, find make
those determinations. And I agree the consumer should know but,
again, what has happened many times is that this has been used
as an excuse to absolutely walk away from — walk away from the
reasonable application of concerns, and then the parent just gets so
overwhelmed that they no longer have a rational basis on which to
make a decision.
Mr. Burr. The gentleman's time has expired.
The Chair would like to thank the members for their participa-
tion today and since this member is not moving as quicldy today
as he would on a normftl day, I am going to ti? to allow Henry and
I at- least 5 minutes to get over to vote.
Let me first say how thankful we are to the witnesses that are
here.
DigilizcdbyGoOgle
170
Your testimonies are veiy valuable to the dedaions that we have
got to make and to Ms. Chuda, let me say this as a father of a 10-
year-old and a S-year-old, I'm very concerned about the effects that
the decisions that we make have on children because I have got
them. Many members up here do, so we are searching through the
available information, the new technology, the new data to make
sure that the decisions that we work with, that we are able to com-
municate that into what we plan to do and I again thank each one
of TOu for the ability to hear your testimonies today.
This meeting is adjourned.
[Whereupon, at 3:14 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows.]
Y C. Robert Taylor*
INTBODUCTION
exaggerated economic, environinental, and health tradeofi
__e involved in pesticide poEcy. Theae tradeoff are eapedalljt appannt in peatidde
policy related te fruite and v^etebles. In an Elditorial in Science magazine, Philip
H. Abelson writes:
The public has become increasing aware that a diet that includes four
or five fruits or vegetables per d^ substantially reduces the incidence of
many typea of cancers. At present, suppUes of these foods are abundant and
relatively inespensive. But continuation of trends in the cancellation (ban-
ning;) of fUngiades could l«ad to food scarcities. An increase in the contami-
restricting use of pestidifes on domestically produced fruits and vegetaUes are pre-
sented in this report Out of necessity the analysis is a tooad generalization. First,
the policy debate has not matured to the point where aiur of the mqjor players are
wiUing te define poUcy options witii sufEdent detail for them to be sulijected to rig-
orous economic and risk analysis. Second, only a few estimates of the fivit and vege-
table yield and production coat consequences of pesticide policies are available.
Third, existing date on fruit and veget^le mailcete (price, acreage, coat and produc-
tion) are not suited for refined aniaysis of the food quouty dimension of pesticide
policy. Nevertheless, adequate information is available to aflow estimation of the di-
rection and order of magnitude of the economic impacta and tradeoff associated
with pesticide bans on fruite and vegetebles.
Six categories of commodities are considered in this study: fresh, frozen, and dried
fruit, and fresh, frozen, and canned vegetables,' Policy options highlighted is com-
plete elimination of pesticides used on domestically produced fruit and vegetebles,
and a 60% reduction in pesticide use. These policies may aeeat extreme te some peo-
ple, but the^ ere not out of line with proposals introduced into the U.S. Congress,
nor out of hne with a strict interpretation of the Delaney Clause that calls for zero
tolerance of pesticide residues on processed food.' To the ^Aent possible, the effecte
of the policies on pesticide residues In fbod are also considered.
' Eminent Scholar of Agriculture and Public Polity at Auburn Univanlhi. Partial flmding from
the American Farm Bureau Reiearch Foundation (AFBRF) ii jratafillly acknowledged. Con-
atructive review* by Gary Falrchlld, Edward W. McLauidilin, Ron Knutaon, Ed Smith, John
Adrian, Patricia Duf^, ArUn Smith, Tecry Francl and Scott Rawllika are alao gratefliUv K-
knowledged. EttlmatM of economic impacta preaented in thii report aolely reflect the analnes
and views of the author, and do not necaiaanly reflect the poaitloD of tfae Af^RF, Auburn Unl-
versily m- any of the reviewer*.
* Fm* a diacuaaion of commodltia* included in theae ugregate catecDrie* and a diaeuaalon of
fruit and v^etable date voids, tee the USDA report by Putnam and ADshouae.
* Also, mmor uae peatiddes, many of which are used on fhiit and vegetablea, are ilowly beini
mthdrawn from the maiket under praeent legialalion, with poaaibly targe cumulative enecta oo
produdloa. Glaneaai and Puilbr ateta:
zcdbil^Xigle
PBSnCIDE RESIDUES IN VBUTT AND VEOBTABLES
Two extensive procnuni for Bompling pesticide residues in fruit and vej^tAblea
were conducted in 1£^2. One was done t^ the U.S. Food and Drug Administration
(PDA) Pectidde Program as part of its residue monitoring and enforcement pro-
nun, and the second was done by the USDA (1994) Agricultural Mariceting Service
PMtidde Data Program (AMS POP). The AMS PDP survey was for 10 fresh fruite
and VKetables moaitortA in 1992 in California, Florida, Michigan, New York, Texas
and Washington. The FDA program was directed toward enforcing tolerances and
thus may n^ be an unbiased sample, while the AMS PDP program was intended
to be unbiased but used more sensitive labcvatoiy techniques and was thus able to
detect more residues than in tiie FDA analysis.*
Results of the FDA sample are shown in Figure 1 for domestic and imported fruits
and v^wtaUes. A nugori^ of the samples had no detectable residues. Althou^ im-
ported fruit and vegetables bad a sbnitly lower level of detectable residues, &ey
also had a hi^er pooentage of samples with residues that violated FDA tolerance
standards. FDA estimatee wei^ted by consumption from domestically and imported
fruits and v^etables, show that an average of l.S4%of all fruits and vegetables vio-
late standaras."
The results of the AMS PDP sample, which utilized more sensitive laboratory
techniques, provided a somewhat surprising result In this study the percentage of
residues that exceeded tolerances is 1.1%, below the 1.84% in tiie FDA study. Be-
cause of sampling design, the AMS PDP study may be more representative than the
FDA study.
Domestic Fruit Domestic Vegetables
«— . — T*™
Imported Fruit Imported Vegetables
Figure 1. Pesticide Rcsidnca in FDA Samples.
*Aa mqtetrstion of pestiddM noceedi, many minor use rai^ttThtioDS are being voluntuily
withdrawn by the rcclstrsnts. Lwi of maritst Incentive and fbar of UabfUty hinden th« mglMra-
tlMi of new chemical* for mloor lues. Conssquences to growers of fruits and v^etoblei from
' ' U will include higher cosU fin- pMlddei, gruler riik of
Management Programs.,.. As yet, public pidig'Oi
needs asMdated with minor uses.'
*Facfain considered in the PDA sampling plan Included reoently generated FDA reeiduo data,
reotanal intelligence on pestidde use, cfaamlCTl charaeteclitica and todd^ of the peetidde, and
other fKton. In additlDn, FDA allowed tbr dlsctettonary analysae.
"'Hie PDA BTerago wee celnilated b; wel^tlng reaiduss bj eonsumptlaa ftom domestically
and imported fruit and vegetablea.
DigilizcdbyGoOgle
The USDA (1996) m
MUM it sUtM th«t th ^— -, — r-__
le>v« det«cUble radduea, even wltfa their hi^v tenaltive teita. The Gsw peatidde
tlut were detseted wan near the level of nwtH(fiM« risk were dther banned lon|[
•go (DDT and DDE), or are chemlcala uaad in poatharveat prooaaaing of fruit a
vcgetablea.
Ten Freth Fruita and Vagatabtat
Fignn 2. Pcatkidc Reaidaes in 1992 AMS PDP
The FDA data also show that pevtidde reaiduea in domestically produced and im-
ported fruita and v^ptables difCer. Chanoea in domeatic peatidde policy may change
peaUdde residues in food grown in the U.S., but reaiduea on imported food cannot
be igncnvd. Importa accMunt for over 16% of all freah and proceaaed fruit and vegeta-
bles consumed in the U.S., and a much hl^er percentage during trffseaaon. Importa
are influenced by a variety of factors such as foreign exchange rates, but the imprnt
ahare of domesticallyconsumed food can be indirectly inflaanc«d by pesticide resiric-
tions in the U.S. Thus, induced changes in the Impwt share (rf domestlcalty
consumed food (and pestidde residues) should be considavd in making dooiestic
pesticide polin.
A USDA (1996) analysis of the AMS PDP daU combined residue estimates with
food consumption data to estimate MSticide intake fbr averase adults and average
1-year old children. Th^ considerM both ttareshdd and nonthreshold peatiddea m
deSning negligible risk.' FDA conducted a similar total diet stu^i;. Both the ESS
and FDA studies concluded that dietaiy intakes of pesticide residuss were well
below established standards. Nevertheless, reduction in pesticide use remains a hot
policy topic, perhaps because of factors su^ as (a) the public's fear of pestiddet and
other chemiula, (b) distorted media hype, and (c) allegations about environmental
and wildlife damages.
SPECIFIC PESTICIDE ALTERNAITVES ANALYZED
Analyeia of the aggregate economic effects of pestidde ptdicy iwniires information
on how per-aere crop yiuds and production costs are impactea by tne polides consid-
ered. A recent study by Knutson, Hall, Smith, Cotner and Miller (1993, 1994) is the
most comprehensive review currently available and is used as a source of yield and
cost estimates on which to base the following aggregate economic analvais.^
Peatidde policy options to be evaluated mustbe consistent with yield snd cost es-
timates used fbr the study. Since the Knutson, et al, study was used for yield aiid
cost estimates, analysis is restricted to 60% reduction ana total dimination of pes-
tiddes used on domestically produced and processed fruit and ve^tables. The poUn
sltemativea analyzed here are (1) a 60% reduction in peatiddes (herbiddes, insecti-
cides, mitiddes, and fungiddes) used on domestically produced fruits and vegeta-
bles, (2) complete elimination c^ pestiddes used on domestically produced fruita and
• Quoting from tha USDA (199S) itudy, Thrashald partiddM m those tm iriikfa vny low Is
«la irf' exposura (up to tfas thmhold quanti^) cause do iU rilaets. Nonthrashold pestiddes ai
those fiir iriiieh tfierr ' " '— ' -'^- '- ^-' ' .CTT!\~_., _
tcida, nsgliglble risl
lilMlme ifikoif I eai» . „
Is tbs BsAraoM Doss dstsrminsd by EPA Hm Refinnea Dose li ■ntenlly 100 tinMS Icnrar than
the fw fiHwi n" doss tibat has no hssith effsda on twptTitwifntsI anitoals.*
'ms study, Uko most studios of ylsld and cost offeets of psitlddB polity, is not without c«a-
DigilizcdbyGOOglC-
17S
vegetables, and (3) complete eliminatioii of pesticides used on domeatically produced
fruits and vegetables, with a ban on all imports of fresh and processed fruit and
vwetables into the U.S.
The first two options allow for imports of fruit and v^etsfales, even if they have
C'idde residues. The latter option is included because if the purpose of a pesticide
is to reduce or eliminate pesticide residues on food, then the issue of residues
1 imported fbod roust be addressed. Broadly defined policy options for imported
__odB are to (a) require countries that e»ort to the U.S. to euarantee that the food
products are reddtie fr«e, either by testing for residues or by imposing production
foods are to (a) require countries that e»ort to the U.S. to guarantee that the food
products are reaidtie fr«e, either by testing for residues or by imposing production
constraints like those imposed on domestic production and processing, 7b) have the
PDA or another U.S. Agency test imports for residues, and (c) ban imports of all
fruit and vegetables. The first import policy would be difScult to implement The
second policT would be quite costly, because it is very expensive to test for pesticide
residues and this type of policy might reniuire testing a large sample to insure com-
pliance. The third policy Is incompatible with GATT, but consistent with many past
Bgriculturst policies, here and in many other countries. Analyals of the firat two im-
port scenarios is beyond the scope of tiiia study, while the import ban is more easily
evaluated. Economic impacts of the import ban are expected to be broadly indicative
of the magnitude of impacts of the other two options.
PRODUCTION COST IMPACTS
Estimates of how per-unit costs change under each poli^ draw heavily frt>m the
study by Knutson, et al. This study relied on sdentista to estimate the crop yield
and production cost consequences of the pestidde policv scenarios.
"Tie Knutson, ■ ■ ■ ■ . .~ . - .. .
int growing a
e growing rat
severe pestiode restrictions would have yield and cost consequences that difier con-
aideratuy from one growing region to another. IIiub, production would be expected
to shift to areas with lower unit cost.
Because of incom[deta crop and area coverage of the Knutson, et si, study and
anticipated regional shifts in production, some Judgement was required to translate
Ouii yitid ana cost consequences into per-unit CMt changes for the six categories
at fruits and vegetables considered here. Estimates of the unit cost consequences of
a 60% reduction and totsl eliminatian of pesticides (based largely on the Knutaon,
et al, study, but considering anticipated r^lonal shifts) are shown in Table 1. For
all fr-uits and vc^(«tables taken together, unit costs would increase b^ 30% and 7S%,
respectively for a 60% reduction and complete elimination of pesticide use. These
cost changes correspond rou^y to 26% and 60% yidd reductions, respectively.'
Table 1. Eitimited Efftcti of Pesticide Use Restrldi«is on Per-Unit Production Costs*
■Wwihted Avertp to Wl fniib I Vmti
DEMAND AND SUPPLY BELATION8Hn>8
Econometric estimates of demand and supplv relationships for the six fruit and
vegetable aggregates <fr«sh, frozen, and diiod miits, and fresh, froien, and canned
DigilizcdbyGoOgle
v^MablM) m nuninarily aq>raMe(l In terms of dastidtiM in ToUa 2.* The eUstw-
iUee show the percentage change in quantity with respect to a 1% change in price.
For example, a 2.7% change in production of freeh v^etablee would result mm a
10% change in the wholesale price of fresh vMetablee (TaUe 2). All of the elastic-
itiee in Table 2 are for a wholMale prices paid indez (PPI). Theoretically, these elas-
tidtiss pertsin to a long-run" time parioa in whidi all ^namic wtjustnents to the
Ktidde p<dicy have occurred. However, since demand and supply estimates ware
ed on 15 years of data or less, thrae elasticities may be more appropriately
viewed as pertaining to intermediate-run aitjuabnenta, say the economic effects ten
years after implementation of the pesticide policy.
Table 2. lMi| Run Pioductioii, Export Demand, Inwrt supply ind Domestic Consumption Price Elisticltles*
MK ■■ *aiciiiw 1 flirt* te iniiiMii ffi
or more years, we would expect most ifnot aU of the cost increases to be passed
mates of price impacts are conservaw. ._. ^ ..__^..._ _
Effects of pesticide bans on supply were estimated by ■tuipWing the PPI by an
amount appropriate fM* the pdicy and commodity group."* For example, if the ban
would result in a 20% unit cost increase, then the quantit? supplied at a PPI (index
value) of 120 with the psstidde ban would be the same as the quanti^ auppUed
In the baseline (current pestidde pdlnr) at a PPI of 100.
Tlia aggregate ecoDomic impacts of pestidde bans on prices and quantities were
based on the notion rf an siqwcted msAst dsaring price (PPI) at which domestie
production plus imports was equal to d<Hne0tic consumption plus exi>orla. Changes
in economic variables woe cranputad as deviations from market dearing prices and
quantities assuming continuation of present pestidde use prsetices and current for-
aimexchsnge rates.
'Hie economic model centered on the PPla for esch of the six commodity aggre-
gates. To estimate consumer price effects, the relationship between wholesale and
retail prices were established. These relationships are expressed in terms of price
transmisaion elastidties, as shown in Table 3. In a 8hort--run scenario, retail ^ces
are o^ected to increase by about the asms percentsse as wholesale prices. How-
ever, over tame, competitiva preasure might pull retsu prices down to where th^
eneeded triiolesale prices by a constant absolute (rather than percenta^) market-
ing margin. "Hiub, with a^usbnenta, retail prices would be ^lected to increase by
a smaller percentage than grower prices or whoJessle prices. ^>r exsmple, a 1% in-
crease in the wholessle price translates into a 0.20% increase in the retail price of
fresh v^etsbles (Table 3). Many fresh fruits and vegetables have higher marketai^
margins compared to processes products because of short shelf life and other factors,
lliese hi^er marketing margms usually translate into lower price transmission
elastidties, as is reflected in the estimates in Table 3. ^
Because economic impact estimates are for very broadly defined commodity
groups, it should be recognized that impacts for individual commodities, such as
fresh apples or orange Juice, can be mucn less than or much more than tne aggre-
gate estimates. However, elsstidties estimated for the group are typically less than
own-price elostidtiea for individual commodities because the aggregation mssks sub-
stitution poBsibilitieB.
■Readan interestad in specific ecoDometric results and statiitica ihnuld coDtset ths suthor.
lOTlnM-striM data ware not available on par-unit or per«cre produetiaa wsts under pt ae ant
paatldde uae praetleea. Tliui, the supply analysis hsd to be bssed on oo^ut price only rather
then on yields sod costs or on ezpecteo net retuma. Sbica real pat-»a* production costs and
yield* of most ciopa appear to haTe remained fairly stable over the psst t« yesn, bsaing supply
on output price doea not appear to introduce a se*«(e bias In the •concmebic esHmatss.
DigilizcdbyGoOgle
T»We 3. Iwi-WB Price TransmfsjiOB HwtMHes
CmwM)
EMtcD*
AOaREGATE ECONOMIC EFFECTS
Estimates of the aggregate economic effects of a 60% reduction in pesticide use
compared to current use levels are given in TaUe 4. Wholesale prices would increase
bv 9 to 19%, depending on the conunodity group. Eatimates m Table 4 show that
about H to 4i of the production cost increue would be passed on to wholesale
prices. For example, the 40% unit production cost increase for fresh vegetables
would result in a 17.7% increase in Mwlesale price after market adjustments, thus
passing on somewhat less than one-half of the production cost increase.
Tible 4, EstimitHl Price, Supply, and Utiliution Effects of t 50% ReductkHi in Pssticide Use with No Import
Restriction
httOfO Wl)
■Fnoa mi ami MtmHi taut mM iqiatiani Mh M aMt-«ria aflKti. Dw MfiM W ai Inyvti el tram «|MMM cm
bi ittribiitid IB Hm (mt-prin tHKli ci ii >iii< mUi gun pii* ilMi >mgaR) gf tnnn kuJ amwJ «|it*M) tilm tofrtw iKiMit,
Expending on the product type, retail prices would increase by 3% to 9%, which
is a much smaller percentage increase than for wholesale prices. Associated with the
price increase^ dmnestic consumption declines 4% to 7%. Domestic production de-
clines by a hinier percentage than consumption, because of the export and import
•cHustments mown in Table 4.
Estimated economic effects of total elimination of pesticide use in tho U.S., with
imports allowed, are shown in Table 6, Depending on the commodity gifiup. whole-
sale prices would Increase by 29% to 64%, and retail prices would increase by 8%
to 28% as a result of market adjustments to assumed unit production cost increases
of 46% to 100%. Export decreases would range up to 30% and import increases
would range up to 62%. Domestic use of &uits and vegetables are estimated to de-
would range up to 6.
dine by 7% to 23%.
Table S, Estimsted Prica, Supply, and Iftiliiation Effects of Total Elimination of Pesticide Use on Fruit and
Veietabtes, with No import Restrictian
Wdwn (cni
DigilizcdbyGoOgle
Zilbarmui, et al, estimated the economic impacts of baoniiut peatiddM used In
produdng five fruit and vegetable crops in CaMvnJs. Their price duuue eatimatet
ranged from 13% to 176%, depending on the crop and whether the yiela impact was
assumed to be average or high. Since efiecta on individual commoditiet can M fair-
er or lower than for aggregates, their results seem reasonably consistent with those
given in Table 6.
Table 6 presents estimates of the effects of totally eliminating pesticide use in the
U.S., while also banning imports. Wholesale prices are estimated to increase frton
37% to 122%, and retaU prices ere estimated to increase from 11% to 63% with this
drastic policy.
-\t.S -13,1 -100, -22,9 37.1
As noted previously, there is uncertainty about the crop yield and unit production
cost impacts of pesticide policies. Table 7 provides estimates that might assist read-
era who want to examine other iniit and vegetaUe pesticide policies, or who have
different estimates of unit cost effects of the policies considered hero. This table
shows the percentage economic effects assodatea with 10% increases in unit produc-
tion coats. For example, a 10% incraaae in production costs for fresh vegetables
would increase wholesale prices by 4.4% and retail prices by 1.0%. For a 20% in-
crease in unit costs, these price increases should be doubled.
E^otOl- lnp«l
HEALTH AND EC(»JOMIC TRADEOFFS
A few of the basic economic and pesticide residue tradeoff involved in fruit and
vegetable pesticide policy are presented in Table 8. A 50% reduction in pesticide tise
is estimated to increase unit production costs by 30%. With intermediate-run equi-
librium market adjustments, wholesale prices would increase by 17%. Unit ^ross re-
turns to producers would decrease by 13% (Computed as a 30% unit cost mcrease
minus a 17% price increase). Domestic production would decline by 6%. Retail prices
for food and vegetables would increase by 9% and consumption would decrease b^
4% I^XKluction changes cranbined with per-acre yield changes underlying the unit
cost increases suggest that acreage used for production of fruit and vegetables in
the U.S. would increase by about 1 million acres. This fruit and vM;etaue acreage
expansion would largely displace other crops, some of which would move to mar-
ginal, more erosive cropland! To the extent that this hBi>penB, erosion, r~''' *~
DigilizcdbyGoOgle
a o; 45% baaed on a 75% increase in unitproduction coata. Groaa returns to
domestic producers would thus decrease by 30%. Setail prices would increase by
27% and consumption would decrease by 11%. Acreage required for production dif
fruit and vegetable crops in the U.S. would increase by about 44%, or 2.6 million
acres with toe ban.
Table S. Impact of PuticHle Policies on Koy Ecommic Indices for Ml Fruits and Veietibles
[MnWw>]
[ummm
Km
m
as.
kVnUS.
InporttM
Vioiithe PMlicide RuiduM „.... , 100 lU 2t
(l.M%) IQMX)
Also shown in Table 8 are estimateB of the effects of the polidee on pesticide resi-
dues that violate FDA standards. These esthnates are based on FDA pesticide resi-
due monitoring data, and the mix of domeatic consumption from importa and domes-
tically produced fruit and vegetablee shown previously. Wtfa current pesticide use
patterns, over 60% of the FDA samples had no reaidues, 1.84% of domestically
consumed fruits and vegetables violated residue standards, and the remainder had
residues that did not violate standards. It is not clear how residues would be im-
pacted with the 60% pesticide use restriction because no estimates of how residues
in domestically produced fruit and vegetables have been made. However, with com-
plete elimination of U.S. pesticide uae, the percentage of fruit and vegetables that
violate residue standards would decline from 1.84% to 0.44%, and decline to zero
if importa of fruita and vegetables were banned along with elimination of U.S. pea-
tidde use.
As Abehon not«a, however, there would be adverse indirect food satiety con-
sequences of severelv restricting or banning pesticide use in terms of increased con-
tamination by fungal producta and by phytoalexina created in self-defense bjr plants.
Another potential adverse side effect is that the increased acreage resulting from
a ban on all pesticides used in m^jor field crop production along wiui pesticideB used
on fruit and vegetables would increase acreage under cultivation by about 33 million
acres." This acreage expanaion would occur on marginal land and would ittcreaae
erosion and sedimentation, increase use of GertilisaF and ener{^, and reduce wildliiie
habitat, but would have pooitiye benefits to (nmi peMtdde) agncultural iiq>ut euppli-
yond the scope orthis study'
C<»ICLUD[NO SEIURKS
There have been several recent legislative propciaals which call for severe restric-
tions on pesticide use, and a Court of Appeala decision that haa called for atrict en-
forcement of the Delaney "zero tolerance Clause. With such severe restrictions on
pesticide uae, fruit and vegetable producers' income would fall, consumers would pay
more for food and consume fewer fruit and vegetables needed in a balanced oiet.
In addition, there would be indirect effects, including on increased health risk from
nonpesticide sources, and an e^wnded crop acreage would inereaae erosion and
le about 3 million acrea, andlkiid ii. ^
.. — -„ ,- _- , , , -Jtton, peanut*, rice and hav) would incnaia
■bout 30 million *crei with the tun mctended to all paitiddM used in anieultural production.
For a diKuMJon of reitrictini pertiddae uaad on major field cropa, see Taybr, Panaon, Smilll
and Knutaon.
DigilizcdbyGoOgle
178
Mdinwiitatioii and decrMM wildlifs habitat. The racant FDA atudiea concluded that
dietary intake* of peaticide reaiduea wen well below establiataed standards, and
USDA studieB (19M, 1996) coiroborated this finding. Thus, peaticide use restrictiona
on fruit and vegetable production and proceaaiiu would nave extremely small or
even infiniteaimal ^ects on pesticide reaidues in lood.
Slniifieant adverse economic efTecta and some unintended adverse side-eSecte on
healui compared to eztremelj small roductionB in pesticide residues in fruits and
vesetablea brioK into serious doubt the social desirability of severely restricting,
from a food saie^ viewpoint, pesticide uae in fruit and vevetable production and
processing. Environmental and wildlife benefits of pestidde use restriction are
largely beyond the scope of this study. However, this study shows that increased
erosion and reduced land available for wildlife would occur from severe pesticide use
restriction. These namdoxical aggregate effects on the environment and wildlife
need to be weighea asainst an^ possible benefits when evaluating pesticide policy
fix>m an environmental standpoint.
Rather than severely reatiicting pesticide use, as called for in several recent legis-
lative proposals and in the Court's interpretation of the Delaney Clause, pestiode
policy attention would appear to be better directed toward (a) lowering costs of de-
veloping and registering or rer^pstering safe pestiddra, particularly those used o
friiits, vegetables, and other minor crops, (b) increasing tne efficiency of identifyins
individual pestiddes that pose health, environmental or worker aafetv problems, (c)
eliminating tiie fragmentation <j peaticide regulationB in Federal and State govei
ment, <d) taking a balanced view of risk, considering all sources of risk end the e
nomic adjustments to price and risk chan^, and <e) increasing adoption of inte-
grated pest management (IPM) and nonpestidde control options.
Abelson, Philip H. "Adequate Supplies of Fruits and Vegetables." Science. VoL
266. November 26, 1994.
Food and Drug Administration, "Food and Drug Administration Pestidde Pro-
(p-am: Residue Monitoring, 1992." Published in the Journal ofAOAC International,
Vol. 76, September/October, 1993.
Gianessi, Leonard P., and Cynthia A. Puffer. "Registration of Minor Use Pes-
tiddes: Some Observations end Implications.'' Agrieulturai Reaouroea: Inputa Situa-
tion and Outlook Report. USDA, Economic Research Service, AR-26, February 1992:
62-60.
Knutson, R.D., C.R. Hall, E.G. Smith, S.D. Cotner, and J.W. Miller, Economic Im-
pacts of Reduced Pesticide Uae on Fruila and Vegetablea, American Farm Bureau
Foundation, 1993.
Knutson, R.D., C.R. Hall, E.G. Smith, S.D. Cotner. and J.W. Miller, "Yield and
Cost Impacts of Reduced Pesticide Use on Fruits and Vegetables," Choices, First
Quarter, 1994: 16-18.
Putnam, J.J., and J.G. Allshouse, Food Consumption, Prices and Expenditures,
1970-90, USDA/ERS Statistical Bulletin No. 840, August 1992.
Smith, Katharine Rdcheiderfer, "Sdence and Social Advocacy: A Dilemma for Pol-
icy Analysts," Choices, First Quarter, 1994: 19-24.
Taylor, C.R., J.B. Penson, Jr., E.G. Smith, and R.D. Knutson, "Economic Impacts
of Onemical Use Reduction on the South," Southern Journal of Agrieulturai Eco-
' I, July 1991: 16-23.
ted States Departme
I Indicators, USDA/E
United States Department of Agriculture, Pesticide Data Progra
mary of 1992 Data, USDA/AMS, April 1994.
Zuberman, D., A. Schmitz, G. Castcrline, E. Lichtenberg, and J.B. Siebert, "The
Economics of Pestidde Regulation," Science, Vol. 263, August 1991: 616-22.
Digilizcd-byGoOgle
Reprinted from:
Public Health and Epldeniology Reports of Ontario
Volume 5, Number 8
August 26, 1994
DiBiiizcdbjGoogle
ORGANOCHLORINE
RESrOUES AND RISK OF 'nn<».o«b.br
BREAST CANCER thttrnttaJt^acauuai. (ER-negnive tuowun
— - .■ I wcoribkorbladiniiahnnoiiwleorleuofaitiittd
Cat
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llMdbiDqr of lbs hypotboli 1* dalmd frota dw
nl^ooA^ Rondi M ba MttbHibed.
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remaiflwl eateoriilly unchnncd. Letidianoae-dilidof icproduciion. Inihebieasu, hcauM
tbeovenll I3.3%lnci«aieln (hca|e-adjuiledntalbr ornromil iluue. the gnwth of tn
Invuivc breaii cancer* teen beiureen 1972 and 1913 lyttemandthedepotiiioDof AiL A( meoopame. ihe
could be attributed lo ihe uie of tcreeotDf ovarlet ilop lecrctlni eiiradlol. ciirooc and
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pmettaooB, EtUDgeuciDbccHclBOgeiilefriBveli rewiichcit'**' tuve poinilued Ibat the etttM I
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pnteccs preownopuisil womea fiatn dii) aOecL ihcdevdopmenioftfilidlieuc. Enrogeot itc koowt,
Rlak Paetora tor Brwat dnear W niimilitt iineticilly Bliercd bnui eallt to divide.
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l9petpliili)li*veiboui(b<utbDailKiitk". Oenetich Ravlaw of the History of DOT
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DigilizcdbyGoOgle
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<Tg^;,^?ya, frrfl fii Witdki h rati « ilimMy kvtit "we »we ao w i rirtnll y it g n l flrMr diaaneei «nd
oflOMOOppdihoi w w.laacel»dlltledide^DPr '^"■'""w'nJ'^lhKtiramiMmiiwrjtiiWf^
cMiMd -low cndrbMuic-ceU cociiMaMi nd ««»<«V»fi*PCB««IDDEiodueedc«iiiofeoMi».
«» p». -puK-ccuB^^BD ThB)'.l«.ip.e«m«dd«il»hi«herlwdofPCB.
ofDDTpNdBndUwr *»«w'"''«*%«>f a«»oBlifcepfcqpiawdKw n d
tenbMctait P**M'*"'^fc*''"fc>wJ»imf»>-d*«th«ttnw«lQaMd
h, HiLwi •Mwwi*fc ifae mrtriHaatioB of ■ ri i p oi f duueindim o dttD tt ,
- am. A107c»Fnvectiv*Mlow-iiptmdyof919mMnd
MS weaMBwhaNttnmODTlaveltwmmBMndkikB
in aU-lfKt. tadl CT Mi ao comjmwm rlnin rnipnnw
m wM Jgoi hlp w d wtd b i i—Mi c Miuj umu flty wwd
la MnmlKDTlBvdi*. IibcbiheBeM level efMnn
Uaimtry enfanH*". It elfo hspdrnd npradookm om w« lower noas mH^mii who had died of
Mdtodevclopmenilnnbb<tt.bMi,do|indiodeBti. mlOUiqipai«(ciKer.lk«iilwMtmaa|thoM«ke
hidMt newly MOiMivaKladaaitaip Out^vMr '
lalmdbMWMo l9T6and IMS,
I tbe bawiUi of
Mofd>
tt«tIX/t
«Z;S^«^^oS^ d.dlta.b.,«.tw)««^ttA.l«abdaitapd.ed
L l iiil WtoBi inivembteq]idrnudotfc«l«adk».eueh occsttabMqiMoiiodwlNRNlDGtieBefihMepeidddM
M tnuU uniple dm, lack at conddetatlon of eadlbllowtacawtSeleallUcaGy oeriod.
oooftH>»llo|fKI»tadodiMehen^^leiqM^^ m-11-ye.tHmW.wft-wliidi.wnlBedmldu-
*°^?*^irfL'°!^^™^^, T . '>' I»IP=yeUe •w™*' bydweiAoM (PAHi) and
dlIBcnti.Puikut*flyootewardiv.iitliufewiruq>or (««noeliloiin»eoo«iou«i»tiailiebie»«hiof44iwMi
the woAen in Ibe DDT prodoelian pUnu >1>ere c«oerpeiko«»wd33l-«Ulwwon»o. thawed (hew
<x|MtuiEtwiirehl|hwidwbeRnMayepide<niologieiI .eie ao liialBeeM diflMoeei in residue kveli o(
nudlei were conduced, wen MMxeo. p^ qut, fcB^ ^ h«»chlorob«Dieiie <HCB>
WuiernunD at ■[." exemiDcd orgenechlorinc betnen Uw rwB (nKfL A trend however In di ee ted
concenuaiiDiu in oitlitMin bfeui tUtue conpend hi|}ierkvBliofp,p*'^tFr,p,p'-DDEtadPCB(iQ:ih^^
igilizodbA^bOglc
osncpHiuu. TtiHa wenalionsBUioaDUyhlCbB w» fnnhemdiiBed in iraiiB i B ri l ig nl l fawiw , "
ledduo of B-beuetaloroeydotaxioa (dw ptiodial if idjuHmemi foe Uctuioo bad not beco made la Ow
waiboliitofduiotimodUorintl irt c afcM e l i n da n e) In ^olff iiudy. the reiulti would not hiv« bcap
UMwnipktt«kaifN(abmitcweefp>i«iii<P«<M)3£). ugnlOcail*'. Ladulon bit not ccouiaeiuly been
Whtn ^ d«u woe adjiuied fix padty «id ■(•, ilK ■uoelindwjitii lower tiik for bteiMCineer. Abo,
oddi riilo In womMi wiian bnan ftt cmtained mote boem»eotiheUmliedlbUow.upilme(l-dmoB(hifti>m
ibaB 0.1 m| B-HCH/k( hi, wu 1051 wkb ■ Hft eauyfaUolhBnudyl.nMMofttacMcpuiciittpnbiUy
eoafldenoe iuecvtl of 2.0-S5M. tadioHoi «wy badbi«HicuieerUihelimaofaKtM^lna,ihmhn
til-'*-— M"!" Tbe waoi* GoiwBMUd ttBi the ucOtaiofdliMMMDIShMacuMMbeadudid.
dU&waetlbundinilieaiuJyiniqfbiwt wiH w nl e lly TmwwUiiiilalmfilli«lm«1jmtthc<l«itft«Ttiunt
•tewl(ofdktaiydi£te««MabMWMaA>ta«gra^ fbr Mrum lipid oodmi which m^ have afteted the
la 19»Z, Mdc et •L'l niKKtcd ilfidfleuUljF hWKf oewdQy ei iL' icsoned tmUinidaiy muUt itaoiriai
lwelnrfPCTnniDDEia.ninuMnra dipM.aw ie ^^Qeuiily U|h.r plunu con«o«aon.lJ
MlMnftOMM women wifli in i » | M o ck icong M «dio t^na-hhrMrrnTtnt te Ih- p>-tnf <rf y> - mrti -W
aOw«oea*Mibeai«abre.«dlaeaae.L*i».liofp*'- nalipwadei c«iv««l » " *W bwUp bw»
DDT WW* ilN eknted WMni OK^ but were not tumonn. WhmHwfaiBp M tnHiiwnmllHnvMedlnw
mdrteeUyripiUlein r . imiqMMeocdin|»ei«nteaMccpiotttMot,ihai«Mlii
WoUTet iL' eoiu in ue J tUt lexaidi and pDbUitaad proved mora lnMt«ltln|. Tlie mean adlpote
liBdKritlaIalnl993(WaiEE«(«L.1993}.lUtUfaid coaeenlrtteniofec|BiiodilaffnMhiawEIt-ae|^ilve
ilialj i l iiail lliliiiBlnmrlrinfll'mt-mTaiin ciia pdewi mte feoenlly lower Ihu Owte fal Ae
«MiM between 19U and 1991 ia d« New Ye* cMmlantjMlt. IndMBIbTodtiwapitlBnlihawiew.
UalwnltyWeraeD*iHeihbSiD4'- Cobonmcotai nMa£tteanGeanaouofDDemdK8oaa|CMr»
«ltt developed bcBMt CMKcr wen iadaded ai ceee wan d^ficandy U^ier Ann Ibeee ta tiw ooaod
pukaM hi ihi* neend eaio«eoBM Hndtjr md wen ndjeett. Iiiillii illfBi ei ii«a iiliimini irtim
cooyend u women la the Hudjr p o ptl i rt on who did pUnDtMBeenimlga)«fDD6weNcanpmdOJa|f
potdavolepltBditeaK. A4jawneMi wen made hr L In coataim^aca venui U agO. hi BR-peddn
poedfalaeoaAHHidln(bctanlacladfai««|eBtmnaicbB, me plena. AnledveriefcofUwHcalenlatedte
a^ at flmWmi. body man index (kfta^moMbeof ibe caeaa osifand U ibe comoli. Tbeie laaidB
laetetiaa. fiM d^iee ftmily blM0i7 ef hreaft etooei wyett that woomi trtlh beancaeve^oaiive bnM
and ofbedtabwa ft iUaa w .bUmy rfea o l riin , a Vnhn l cuMat,baveabl|betbodybi«deoofDDEihanwaaiM
cOdSimptionandtaEe. Only covariateitbtiahend die widibcaisBbnaMdlMi*e,aadippeai*ioti9pa(titaB
i^ic8doncocfBclenttordwvariablabya[leaKl3% |ij[iicliiiHil1iiliinililiainri[irnfihlf miini "
were Included In (be flnttmodeL m^ efhet tbe Incldencee "
TbeiauInibowedaKtnkvBltofDraandPCBiWBR '^ f- The wwludow
hlgberfortbeSBciietcoitqinKltaibBninitthed nladoaiUp.
codtroU, but tbli diffaence wai only itHlMically b April of ddi year, KNl|erel(l.<pubU»MddHRwlii
diaificiot lot DDE. DDE coaeeatmlaae wen cfltaelUbetMndylnwhictabloodHaipleidnwmMri
^yoxlnw«ly33*hi»hefin pt ti BB mh»aUcBQiroto. b„u dnrioi rautlae pbyiical cxamlnaclent of
«4UlePCBI«eliwenl31lhlfber.WtaiQaxainiaade( tbouiaodi of women duiUis tha late 1960*. wm*
aoonti n uoiu riik tae«of . then wei ■9* bcteaie Intbe aialywd. Su»pleiulainframl50womeii(S0Atian,
adjuited oddi ntlo <0R) fof bnut ewwtr per unit jo t^iefc and SO wbite) wbo bad developed bnatt
iacna>elnDDE.T1)J«ewTetpoadBd(aaIta«-faldriili cuoiriiiivttiteorMyeutlHorwcteinaichedwldi
foranelevidoDOftenimDDB&om2.0(0 19.lB(AuL ijOcoDiralt. No auociuioawuttiuiid between aenm
■nKrEwainoilgoiOanidiRereocelaPCScoooenciMioo DDT aad PCS leveli and rlik of breait cancer. Tbe
betw«nIhepiilentiUiddiecoiimk.WbtabolliPC8i iMUlUOflhiittudyircmoracaovlDClng than IbC Wolff
and DDE were Included In ihe model. DDE nffiabed Kudy became tbe unipit tite li larger. It ll a HIM
vlnuaily unchanged, while the coeffldenl for PCBi pioqiecllve iludy wlUi in avenge period of i*y—gii.
r
DiBiiizcdbjGoogle
o devdopmeai of tbe bkoad,wliia)eiituieilURtoMidlotiinwi. 16-dptui- 7
slwiAibBveiyitmtMmoMlipcriod liydrax)r«Mi«ae Uwti two dineiCDi ways (o cnrofca
in ibe Wolff iMdy.uid tbe wmpkiweRiilceapclorto recapon - ( eovilent bond, fonuing tiiducu, tod >
the 1972 b*D an DDT wben women woe eipoted lo cluiicil noncavikot inunction ■Imilii' (o Uut of
inuchbifberieiiduclsveliibwibeyaraiodiy.biialia cnndiol''.
Mc.oitlq' d>u dw» obfcnitiani aMwt ilMrply Brtdlow"h..b«d «u<lylng<bcc(fte«of polycyclie
wiita ibose lepomd by Oammy et >1.> u »hiek die mn«aehyto)CHbon»indi«rioii.pe«kiil«.oiiihB
unboniwCBdatiiaiflcuUyhlctaereooaMntioaar atubeUofaHityaaiam„^ta,^l«l^in ^ijt,^
DDBm^-^imot*^^^^o^«^ lq*oxyeittope.ir*eKd*odc.Ji.idduding<M>-«)T.
po^vebfewtCMM«t.Tliebhwdnn|)kiiniU)(tDdy qqe. kapow «ad umtate. cnbuce lUi pMbww
coanlaadDDEkvebfcnrlinieiicMuritiiollnMia pw,dBdn,mhrTk*elnrfifainne«»bolHc!MBwiaw
lhcWolffiiudy.»dy«w»»ociidoowuft«nd. etaim^Uu* could iu|jwin«»cl«lonbetw«Bllwe
Dtocuaslon oompouadaandbRutcaDcir.CritkilMMibypalbMit
iri>DTeqiDniicii«TlikfMtorliibretttcm».U bowevet.U ttaeideciioDarcanUolt. Ooe Inpstnal
wMildbehmfaeinqiponedilaplnttibleiDedinlim criMrioafordMenniolnsttaeiitalficwicecfapOMlble
could be Klvtaeed. While i>^'-I»3T hK Mmgenic «abuc«Bemof dw IS-a^Au-bydntqrUckMi patfamgr
Kaviiy.aolyp^'JlISwueniiiHIcdlaltoWotfrtod bydiMediaiiicdLHIbtqiedSdtyoflbeiteDMMMn.
DewiiltyHudiet. p^'-DDEhuiveiy weikeKia(enie Kmtny uueHMdiiAmiicei bducatlUipUbwty.ilK
efba,if ■ny,umBiimdbyncs|MrUndu(.bowew. eoaebuSoat miy bedUbmu.
dmeiKMfacriaedauiifintlbiiirtnpiblcofpradueiiv Cotwluion
Tlw niolafy or bfctn cocer li DM fiilty tmdenuod
DBriiitibeinMibolistnofeitndiollnbumti<t.l7B- """ fy.'?^*!* ' "??''"!!" ****'"*''*''''*'
eitndiol is converted lo Mtrone which ii (hm ™pUc«nenire^m»««»dptixwewoj«iiiidlbod. M^
mMiboliwd vU iwo prinuiy pifliw^i Tbe I- f«>d««i">»«wlyeoii«iiiede«.i.iii voyhifh level! oT
bydnnyUiioopMh-tyFcodiKesweikeitraiaiiMch '^«or^ Fe, omo^ abbtfi amoiia 2A00 i^
>3.bydnnytnra«.wUkiiilbeNcandpithw^.l6- nWroiwO^oi-rvlnl-.IiiipoBibleitacoMun^Kloo
rilto^iydnwyUiepmdueet 16-»ltto47i l n« yei ttoii e . of&odihifhmeiWifeameyeooinbuteiiioreiodw
wtilchhMwtrogenlcictlvityeauiHodwofeWniJioI". risk of develoitoB btewi ciucer Uun eivowre »
Ifr*lplii-hydro«yctlrODe no, eoMrtbme to bnMi MWiwie eompouwli, lucb » wtuochlorise
cucerioddcncciiace women with tbe ditcMebevet pe«in<l"'
SOIt iocreue ia l6-ilph>-bydrmyUiioa compend lo ThcbcaK>iiilnbawe<Nr,diiibretiictnoeriaddeace
contrail. u>d its preunce could pi«tang tbe ettragcnic hubeeninctea)iaB0v«cttaepi«20yeen:ihemimber
effccBofestruIiol'. Increwed Ifrilphi-l^draxylue oTeMrotenieepMiiiictumoinitiiicrattiiis.peitieuttriy
■eiivity in mice h» been utocleled with the mtoat older womea vte could be cuiTla| • pttMEt
ioinctEuedDNAiepiinynthefispcaUrenaveicuvlty 10 ycwt. tl li pCHiible Ibil
cotnprndtatheconirols^OOlV^Iiilsohuroiiumal breiMunceiiieeniaihclsaOtudearly 19Miwera
Uodingiffinliy 10 MX hotmoae binding globuliiu in ibe cuuedby'in^oreavltMinetiulcooununinipKseM
DigilizodbyGOOgle
c>aaocberukdoin.ireipaNRHlS)TimliBpon«nt |
ri(]cf>nar,aciciroiild«xpai3wiccadcdlBilnbniM |
MOceri iir ii> ene« lncqualrk«Trtigetou«e hm le c lto«d I^H^iBhOiMta. l-MO-UMTM.
arcxatcd. lodevtfopiagcauHilowliBRDDTURlU i. " — ■ — ■■ ■— ■■-— liuiftulii, p,
MCd, tbl) ttcod nay not bt IM«d Wlqr?(Kmllipan). JMrfCMwIuf Ifm tKIQim.
WkBeitisblolofkiUrpUariUBteiDDTei "^
wild be ■ mbMt itefc Actor far bnut CMC ,__...
i^daaealtDdiMdvaiaag. RavinnbylABCHdIb* l9Mll(ft«»4*6.
■rasa mnMcilve Hudv nm *r*»^ n d«e do DM *^ mnnat. L Uiy i w t i n . Vtwwiu wm»i w. >i
pldemiolo^cdMidicia(iaaBiBttnDpleii»Md "- ^"^ '*— '*)**>w- w.CB«wi«i*-tim
ilHjWii pnucot 10 dnw a dtflnUM o
vahwetliondeef]
Cnur Ota Or»l I W: 14(1 ^ »-*3.
TliHIia'. IMS A. WMfOY.
IMndnlHbBacvU '
1 IB. Rmi XK. PIki MC. KoiBOiil
ssmA
n. nteMCHcii4neiiBaKnll«MDt(«L »nimCmmhi
YOM Wmb ud Uh at On] COHmpdn: rwWi
MadM^EaurfPomnili&HMdAiBiifUM. 1«IM1
.._,„. , . iniiTitlMJO.
fMQMHrMrKKMCttsn-m. kj. MiltaD«,>otiirt«iL,K«fti«DW,S«onexP.W.nfcogB
S. Dt<n%EDedl*S.Vai^It.A«aeF,SHTCUMvfa HLfiarlnS. Bnu Cdw Bifen Aft 45 wd Onl
I. Iri— J. ll»>gil 4 Mrt <0 rtM B«f*n !■*<«■■«* C DW« Htd <«Uit: iw findtoii. AnJS^tfwmmW; IW.
11. Rgal«LWintiWC.CiiUiaO*.PratpKdv«StiidTirOnl
OMv^d<« Uh Bid dH Riik flCBiH Cnor la WsoB.
DB. On] CoMncotivct tM Bn
(CM«r/u) 1991; (5(5;
MM Conor hiIll»n;lS(ll):
DigilizcdbyGoOgle
I«]0-I9M. /AWCMwte>rl*TT;9>:TM4ll.
■ (flnWMtCalBB
f. Mvt IN*: SHI 3B-IM.
r L .nr.Ti"-,..ii irn.Tjiiii^i.ni,nw«Mi.ni j ho — r >« w ii iwo; » h«»-k74.
HiAdWG. M]iHaDMrttuSd»dBiBUiCaMrli*c 49. Rabin Alt akorin DA. SowtfOU. ECTTXiavBAt
^■■■ m tii ii t n tt-JHatCmtttlMi imtWtrMMla Qnndi at » Uw oiw I Hifau l i i ■nn—. rntof Im
31. HaMOR.HnhMT.HWgs'ro.lBHlAlHYaaalK inaKZ7:l»IIS.
KwniiJHil K. UMi B. M—tM R »4«<« fl. >«>»■ T. SO. Brif-W^KiflKP; Bnn(iakAiidaBD(DOTAarion.
TWahr. n ii wi> w|Y.Bii yr iiiiaiiMdWfcrfliMii Aia./M«i«lft]i«:1«)-m
3X. BajdN. NMWaa lad Bnol Cw«. JN^Cmnrlm Fifcii TliiiihrtliitHilMiilliii Tn> '"
■• 1 1 1 J* riidy. &KW fl pH " "W*: ^'tf):
14>0-I4n;
3^ l^nnini AltarinarAcBlriHrar>«»OMa^.
JH^MM/MK IMS; ISC3): 111^1.
_^ ^_^ " * P> On aAXC}. Warid Hott
III |—|l II Aai.;^Mii^*(lMS:llhU4-<T4.
- 11.(9:101-105.
rfUoMlHiniUttefBntnaMrhYMMWaawi: ». Hnian I. OCT. ■fldirtclulo] evMcaet. Ik tWC
«IMS.U:1(R-II
mlSS-Ut. M. WiHninM.ttsfiHlnDF.TDMi>L.M)inAI>.SUbM
41. uadoaS].Col4laOA.)aiBphi.Mlaiil. Uca<taiH« H. Aria G. Cini U. ~i|niiililnwi 'ini|iiiiwi1i h
IU*DrBnWCMarlaiCa)iensrU..S.WaBiL Mi/ > ti af 1mlt mJ h/^am AppmHf Mat—1 »t^ Tiiw.
»MnMlM0;m:l7-lt *tflfi».<iM C a— rlWeailJTt; I3;«71-«14.
31. BwJowU PbiiiiI mminiilrrtia. tlommtm It, IWl. 9T. Ui|tf M. dir R BAdiDi-Teft K Obn I, OiMi J.
3» tWMaM.Eff«««rOldikiMlfliwMddDn<d«MillDOT] Oi^aoAtolH Oi wriMii di !■ Mma B«*H Fm taB
•Ml IWjvMciriuni B^AiHh (mo HiMi at ITV- DmbwI iMiaBj Wl* — I I m i C i a LU »d h . Bl«wr
bndM Bladiu M Km IftcriM ItccapHc. nadkn MuriH faaHwIyl l inw If idg ii Uid ui^ Bi—
nim t ti lOT* M: 4«^4^l. iarjB)!. £«*»a«Mi(«™«*l*idl3«:aMt.
TTiTliHrri llrinrlfHiWI riimnyr ll*i.1w U' AHi>EI.Xd]E,CU>r.Amipa»nMla>-UpSte*F«f
<..<l.lon>ptwylM-<»^hMravi^l).t.t.l- Ci«j Mainjo h Majo. » ia™. DOT. A- J /S4*
Mat iMl la Homafao. Uoflta. K«na«( MnM Itth Wl): «»«■
41. Hiaiiii RR. Schuln 01. Inieranlon of cp'-DDT *lih die
flureita BlaJtat PralciD (BSP) at DMSA-Iiduead tUI
MNBnuiyTiBHn. Ru Ccramn Onm FalM fliannaeel
IMUJXifclW-tlT.
41 KepArD.BalftrWH. M
DigilizcdbyGoOgle
B.T BIsM IJ^"^" •' couIiltccau[UI0riiicninilBiii(1(nb. TUtoueoilve
fi W9i!k(m!^" "'«»'«* ''^w F^n" " •°»'y*l» Of up u d«e
tcieatUtc rcturcb which bu eximinad pouibke eauu]
an K£.KiwiiA. ft h— '="■ linkieti bciwccn (xiuiochlorine midua uid bmM
neiipoMdisHfCMiriuied cmCCT.
r*«rl*T3i2M):l*0.l«. „ , , ....
«KE. ^^'°i">'<»'Of>'»thadcvdopDwiuofbKiKc«acer
lUmof hu lod micucbea 10 Mimine poMible uiocluioa
tii'Woawii'>iAB(EuiaK*r. rncNailAatStI beiwcea breut ciaccr tai DDT (ind In meuboUU
USA \fa:19:Xn^ya\. DDE) lAich luve eMrogenie «!¥(». Attboaifa It It
' K2-ffS;.'^*!SSS;S^^^ hiologkdlypl.udhk*«*«.per.*c««>xIcue«.
(qI^Iii Kwnu MUlt Eibm « Grmih. MartMby lad could barbkbcloabrbteuieiacer. the reiuluwBSH
DivuiMorLKuiKii. AM/A*licM»Ul9n;T7 I29«- compeHllV. Mott <rf the n^aa htw MfTEnd ftooi
ll^^- prwirtlndp, lMit«[ii«im nilh»Li!npniu< l.|fnm..jiy
■^ SCT.^'ssrs' "irassnssK; »»n..i»«iid.i»..i»i«i«,ta,««io..<
(E4karMl.V/'ai(C^iHrteif 19W-.n(11)ilM497. (bBltrewlU. TbcildelcoiMtiaMlbMKCviBWbydK
1. S«»ciklX.mnMl.CBnlMBIa«iit<f>KB>lotMOiH Il M mMtoail AgMejferRM»MhwiCineer(IARC)
■■ l»^yh*41 j id w«jy tm w EMdfaj km^ b wd Ibe ln|Bttpn»iMetive •tudy h»ve not found ra
r. -ji. _i soOTTuidhfMHCWcer.
imioKunciiul Goedlj
B.\wyifmw*- hawiaeaeMingrinwCuMdibiMedtauie. Ito
M. V*i>lalK.R]wI>S. KMnUTOaiintafBn«>l>nM llneaDErTbtliUnuiabcaDtddlBwbeiCUUlUMdin
nad»Mh->it>y>>w. /./^H«ftMtn*;41:5TMt] nuoT ite»«lopln( eouattte*. devitou la DDT l*v«l»
- '■■— ■ miy be noticed aiilicaieaieydeilliroui^ meet aid
DISEASE CONTROL SERVICE ili. BnufndlaiiiibBmitepMliw^brtavonKof
COMMENT Ontario Inhon n OipnachlttlBM. IhsutfiMdlotfor
■nMiisOnario<*oin«a.Tlicte«ctieS7Mnewcneior eipowic.
fanM CMcer dt^nolctf la Oi^rio woowa In 1991 By iovmtai I hniwfl o M on fidi cooiumptioo wban
cxnqMU(<lH3714aeweM«dta|MHdinl9Sl,«39* o^poosUOfta te*e£i excoBd guMelinei. Onwlo ta*
iDCfBueovKteMayewl^HvaL SlmlMy.dHnwM ti ump mi » liinli the expoute of let popukciaa te
■28%lncnueiobi«uteME(rOHniUtyb««Mial9ll DDTiadottgom noflH ori n ei. Some mcm lave been
(139Sde«ht)Mdl99t(17aS^«ht}tadt4ftofibeN dotiJ w«oawM«Ulfl « hi n | a n d advUorin mcIq pLaec
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