Pesticides: Options to Achieve a Single Regulatory Standard (Letter
Report, 05/13/94, GAO/RCED-94-57).

Different standards in two key pesticide laws--the Federal Insecticide,
Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic
Act--have led to differences in the way pesticides used on foods are
regulated. These differences have their basis in law rather than
science.  As a result, pesticides that have been found to cause cancer
may be used on some foods but not on others, and the benefits of using
pesticides, such as increased crop yields, may be considered in some but
not all regulatory decisions.  Several proposals are before Congress to
establish a single regulatory standard.  This report discusses (1) the
federal pesticide laws and the policies that the Environmental
Protection Agency developed to implement them and (2) legislative
options for establishing a single standard for regulating the use of
pesticides on food.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-94-57
     TITLE:  Pesticides: Options to Achieve a Single Regulatory Standard
      DATE:  05/13/94
   SUBJECT:  Pesticide regulation
             Public health legislation
             Food and drug law
             Carcinogens
             Health hazards
             Agricultural pests
             Pesticide industry
             Regulatory agencies
             Economic analysis
             Contaminated foods

             
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Cover
================================================================ COVER


Report to Congressional Committees

May 1994

PESTICIDES - OPTIONS TO ACHIEVE A
SINGLE REGULATORY STANDARD

GAO/RCED-94-57

Pesticides


Abbreviations
=============================================================== ABBREV

  EPA - Environmental Protection Agency
  DDVP - Dichlorvos
  FDA - Food and Drug Administration
  FFDCA - Federal Food, Drug, and Cosmetic Act
  FIFRA - Federal Insecticide, Fungicide, and Rodenticide Act

Letter
=============================================================== LETTER


B-255441

May 13, 1994

Congressional Committees

Different standards in the two key federal pesticide laws--the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA)--have led to differences
in the way pesticides used on foods are regulated.  These
differences, which have their basis in law rather than science, are
often characterized as the "Delaney dilemma," after the so-called
Delaney clause in FFDCA.  As a result of the Delaney dilemma,
pesticides that have been found to cause cancer may be used on some
foods but not on others, and the benefits of using pesticides, such
as increased crop yields, may be considered in some but not all
regulatory decisions. 

In previous legislative sessions, amendments to reconcile the
differences between these two laws have been debated in the Congress
but not enacted.  During the current session, several Members of
Congress have also sponsored bills designed to establish a single
regulatory standard.  Most recently, in April 1994, the
administration proposed legislation that would, among other things,
attempt to establish a single standard.  This report, which we
prepared to assist the Congress in its deliberations on pesticide
issues, discusses (1) the federal pesticide laws and the
administrative policies that the Environmental Protection Agency
(EPA) developed to implement them and (2) legislative options for
establishing a single standard for regulating the use of pesticides
on foods. 


   BACKGROUND
------------------------------------------------------------ Letter :1

EPA regulates the use of pesticides under two federal laws--FIFRA and
FFDCA.  Appendix I sets forth the relevant provisions of these laws. 

FIFRA requires that a pesticide be registered (in effect, licensed)
by EPA before it can be sold or distributed in the United States.  To
qualify for registration, the pesticide must perform its intended
function without causing "unreasonable adverse effects on the
environment."\1

Different sections of FFDCA authorize EPA to set limits, or
tolerances, on the amount of pesticide residue that can legally
remain in or on raw and processed foods.  Under section 408, EPA sets
tolerances (called section 408 tolerances or raw food tolerances) for
pesticide residues in or on raw agricultural commodities.  Under
section 409, it sets food additive regulations (called section 409
tolerances) for residues in certain processed foods.  A section 409
tolerance is required (1) when a pesticide's residues are found in
higher concentrations in a processed food that is ready to eat than
are allowed on the raw food or (2) when a pesticide is added during
or after processing.  However, according to the Delaney clause in
section 409, with limited exceptions for animal feed, a pesticide
that requires a section 409 tolerance cannot obtain that tolerance if
the pesticide has been found to induce cancer in humans or animals. 

Under section 402 of FFDCA, a section 409 tolerance is not required
when a pesticide's residues are not concentrated in a processed food
above the raw food tolerance or the pesticide is not added during or
after processing.  Section 402 is commonly known as the
"flow-through" provision because it allows the raw food tolerance to
"flow through" and apply to residues in the processed food.  Thus, a
pesticide that has received a raw food tolerance can be used in
processed food even if it has been found to induce cancer in humans
or animals--as long as its residues have not been concentrated during
processing or it has not been added during or after processing. 
Figure 1 outlines the process for granting food-use tolerances under
FFDCA. 

   Figure 1:  Process for Granting
   a Food-Use Tolerance Under
   FFDCA

   (See figure in printed
   edition.)


--------------------
\1 7 U.S.C.  136a(c)(5). 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :2

Because of differences between FIFRA and FFDCA--and even between
sections of FFDCA--EPA applies different standards of risk in
different situations and considers the benefits of using pesticides
in some instances but not in others.  Specifically, in setting
tolerances, or allowable limits, for pesticide residues in or on
food, EPA may allow the use of a carcinogenic (cancer-causing)
pesticide on raw foods or in certain processed foods when it has
determined that the risk of cancer is negligible.\2 However, under
the Delaney clause, EPA may not allow the presence of a carcinogenic
pesticide in other processed foods, no matter how negligible the
risk. 

For example, EPA may issue a tolerance for a carcinogenic pesticide
on raw tomatoes if the risk of cancer is negligible.  It may also
issue a tolerance for the pesticide in canned tomatoes if the
pesticide's residues are not concentrated during processing above the
level allowed on the raw tomatoes (the raw food tolerance).  But,
under the Delaney clause, EPA may not issue a tolerance for the same
pesticide in tomato paste if the pesticide's residues are
concentrated during processing above the raw food tolerance--even
though tomato paste is ordinarily diluted before it is consumed. 
Similarly, EPA may consider benefits in regulating a carcinogenic
pesticide except when that pesticide's residues are concentrated
during processing above the raw food tolerance. 

To address these differences in risk and benefit standards, EPA
issued a statement in October 1988 outlining several administrative
policies.  One of these policies, called the de minimis policy,
allowed the presence in processed food of pesticide residues that
were prohibited under the Delaney clause but that, according to EPA,
posed a negligible risk of cancer.  This policy allowed EPA to grant
tolerances for pesticides that could not otherwise have received
tolerances.  Another policy, called the coordination policy, required
EPA to cancel the raw food tolerance for any pesticide that could not
receive a tolerance for use in processed food. 

In 1993, in Les v.  Reilly,\3 the Ninth Circuit Court of Appeals
determined that the de minimis policy was incompatible with the
Delaney clause.  Following this decision, EPA proposed the revocation
of the processed food tolerances for the pesticide uses named in the
court case, but it has not yet revoked the raw food tolerances for
these pesticides in accordance with the coordination policy.  If EPA
retains the coordination and other remaining administrative policies,
it could cancel the tolerances for approximately 100 pesticide uses
in or on food.  The impact of these cancellations on public health
and the economy is widely debated by EPA, environmental groups,
public health organizations, pesticide manufacturers, and food
processors.  According to preliminary estimates from EPA and industry
groups, the cancellations could diminish crop yields and increase
food prices, as well as discourage the development of some safer
pesticides.  In addition, representatives of pesticide manufacturers
and food processors say that the loss of some pesticides could
increase risks to public health.  However, according to some
environmental groups and public health organizations, the
cancellations would not cause such serious economic effects and could
accelerate the development of safer pesticides and benefit public
health.  Industry groups have said that EPA could mitigate the effect
of the court's ruling by revising or revoking the coordination
policy.  Nevertheless, the differences in the federal standards for
regulating pesticides would remain.  An amendment to the existing
federal pesticide laws could provide a single standard for regulating
pesticide residues in or on all foods. 

Options for legislative change that would establish a single
regulatory standard for pesticides in raw commodities and processed
food include (1) allowing zero risk of cancer\4

(providing for a phaseout of the most hazardous pesticides) with no
consideration of benefits, (2) allowing negligible dietary risks with
no consideration of benefits, and (3) allowing negligible dietary
risks with some consideration of benefits.  The administration is
currently advocating the use of a negligible-risk standard with very
limited consideration of benefits.  Because scientific data are not
always adequate to quantify risks and benefits, the choice of an
appropriate regulatory standard entails value judgments and is,
ultimately, a policy decision. 


--------------------
\2 In practice, EPA has generally defined negligible risk as an
incremental increase in lifetime risk of 1 in 1 million or lower, as
calculated according to a conservative risk-assessment methodology. 

\3 Les v.  Reilly, 968 F.2d 985 (9th Cir.  1992), cert.  denied, 113
S.  Ct.  1361 (1993). 

\4 As used in this report, "zero risk" means no intentional addition
of carcinogens to food. 


   THE FEDERAL PESTICIDE LAWS
   CONTAIN DIFFERENT STANDARDS
------------------------------------------------------------ Letter :3

Section 409 of FFDCA--and particularly the Delaney clause-- differs
from both FIFRA and the other sections of FFDCA.  As a result, EPA
regulates pesticide residues in or on some processed foods
differently from pesticide residues in or on raw foods and other
processed foods.  Appendix II sets forth the differences in the
federal laws regulating pesticides. 

Because the Delaney clause prohibits the presence in processed food
of any pesticide that has been found to cause cancer in humans or
animals (if that pesticide's residues have been concentrated in a
processed food above the raw food tolerance or the pesticide has been
added during or after processing), EPA may not grant a section 409
tolerance for that pesticide, no matter how low a risk it poses to
humans.\5 According to EPA, no pesticides known to induce cancer in
humans are currently registered for food use.  Under the Delaney
clause, EPA may not consider benefits in setting a section 409
tolerance for potentially carcinogenic pesticide residues.  In
contrast, EPA may grant a section 408 tolerance for a carcinogenic
pesticide in raw foods and allow the tolerance for a carcinogenic
pesticide to flow through to processed foods under section 402 if the
agency has weighed the dietary risks posed by the pesticide against
the benefits of using the pesticide and found that the benefits
outweigh the risks.  Thus, potentially carcinogenic residues may be
on raw food or in processed food if the residues are not concentrated
in the processed food above the level approved for the raw food or if
the pesticide was not added during or after processing.  Ironically,
EPA has approved tolerances under section 408 for some pesticides
that it has found to be potentially more carcinogenic to humans than
other pesticides for which it has not been able to issue a tolerance
under section 409. 

In regulating pesticides under FIFRA and provisions of FFDCA other
than the Delaney clause, EPA must assess multiple health risks,
including the risk of birth defects or of reproductive or nervous
disorders, as well as the risk of cancer.  Because the Delaney clause
requires EPA to avoid only the risk of cancer, the agency may issue
section 409 tolerances for pesticides that pose other risks to human
health or the environment. 

In addition to the Delaney clause, section 409 of FFDCA contains a
general safety clause that requires EPA to determine whether the use
of a pesticide "will be safe." EPA and the Food and Drug
Administration (FDA) disagree over whether this clause allows for the
balancing of risks and benefits.  EPA has interpreted the clause as
allowing the balancing of risks and benefits when the Delaney clause
does not apply (i.e., when the pesticide is not carcinogenic).  Thus,
EPA believes that it may consider benefits as well as risks when
setting tolerances for pesticide residues.  In contrast, FDA applies
a risk-only standard when approving and setting tolerances for food
additives other than pesticides, such as artificial sweeteners and
animal drug residues.\6

Both FIFRA and section 408 of FFDCA require EPA to consider both
risks and benefits in making regulatory decisions.  FIFRA states that
a pesticide may not cause "any unreasonable risk to man or the
environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide."\7
Similarly, FFDCA calls upon EPA both to protect public health and to
consider the need for producing "an adequate, wholesome, and
economical food supply."\8

In practice, EPA bases tolerance decisions primarily on perceived
risks and presumes that benefits will be determined by the
marketplace.  As we previously reported,\9

the principal role of benefit analysis is to supply EPA
decisionmakers with information about the benefits associated with a
pesticide's use during special review--EPA's administrative process
for reviewing already-registered pesticides in the light of new data
indicating health or environmental concerns.  EPA uses this process
to determine which uses to cancel and which to retain. 


--------------------
\5 EPA may, however, grant section 409 tolerances for certain
pesticide residues in animal feed. 

\6 Section 409 of FFDCA governs the regulation of food additives. 
FDA has primary responsibility for implementing section 409, but EPA
has been assigned responsibility for regulating pesticide residues
that are food additives. 

\7 7 U.S.C.  136(bb). 

\8 21 U.S.C.  346a(b). 

\9 Pesticides:  EPA's Use of Benefit Assessments in Regulating
Pesticides (GAO/RCED-91-52, Mar.  7, 1991) and Pesticides:  Better
Data Can Improve the Usefulness of EPA's Benefit Assessments
(GAO/RCED-92-32, Dec.  31, 1991). 


   EPA DEVELOPED POLICIES TO
   RECONCILE DIFFERENCES IN THE
   PESTICIDE LAWS
------------------------------------------------------------ Letter :4

To implement the federal pesticide laws and address the differences
posed by section 409 of FFDCA--and particularly by the Delaney
clause--EPA established several policies, including a coordination
policy, a concentration policy, a ready-to-eat policy, and a de
minimis policy.  In establishing these policies, EPA sought to ensure
that farmers and food processors could produce foods that were
reliably in compliance with the federal pesticide laws and were not
adulterated.  The policies were intended both to protect consumers
and to alleviate farmers' and food processors' concerns that legally
treated raw commodities could yield adulterated processed foods. 

Through the coordination policy, EPA endeavored to establish more
consistent standards for regulating pesticides in or on raw and
processed food.  According to the agency, consistent standards were
needed because it is often difficult for growers to predict whether a
treated crop will be eaten raw or processed.  EPA determined that it
would generally not establish or maintain a section 408 tolerance for
a pesticide's use on a raw commodity if a section 409 tolerance would
be required for some processed form of that commodity and the agency
could not issue a section 409 tolerance because of the Delaney
clause.  Thus, for example, EPA would not establish or maintain a
section 408 tolerance for a pesticide's residues on raw apples if (1)
the pesticide had been found to cause cancer in humans or animals and
(2) the pesticide's residues were more concentrated in apple pomace
(a processed apple product) than on raw apples.  (In such a case, EPA
would not grant a registration under FIFRA either.)

Through the concentration policy, according to an EPA official, EPA
established a standard for determining whether concentration occurs
during food processing and a section 409 tolerance is therefore
needed for the pesticide's residues in processed food.  While EPA has
not set a strict numerical standard, EPA has concluded in the past
that concentration in the range of 10 percent is just cause to
require a section 409 tolerance.  In other words, if EPA determines
that a food may contain approximately 10 percent more residue when it
is processed than when it is raw, then EPA concludes that
concentration has occurred and a section 409 tolerance is needed. 

According to section 402 of FFDCA, a section 409 tolerance is not
necessary when the level of residue in a processed food "when ready
to eat" is no greater than the level allowed by the section 408
tolerance.  The federal pesticide laws do not define the term "ready
to eat," and it is not always clear what "ready to eat" means. 
According to EPA, it would often not be practical to enforce
tolerances for the forms of food that are actually served to people. 
Hence, through its ready-to-eat policy, EPA sets tolerances for
pesticide residues in processed foods--such as apple juice, instant
potatoes, flour, and tomato paste--as these products are available to
the consumer or the food processor.  In setting these tolerances, EPA
assumes conservatively that the foods will be eaten as purchased, not
washed, peeled, cooked, or combined with other ingredients. 
According to an EPA official, besides protecting the consumer, this
approach is practicable:  It does not require EPA to estimate how and
in what concentrations consumers may combine these foods with other
foods--an enormously complicated and virtually impossible task. 

In 1988, EPA established a de minimis policy for setting section 409
tolerances for pesticides subject to the Delaney clause.  The agency
took this action to partially resolve the inconsistency between the
Delaney clause's absolute prohibition of carcinogenic residues and
the toleration, under other federal pesticide provisions, of minimal
risks in exchange for benefits.  Responding to a recommendation made
by the National Academy of Sciences in 1987 that EPA adopt a
"negligible-risk" rather than a "zero-risk" standard in setting
tolerances,\10 EPA announced that it would treat the Delaney clause
as subject to a de minimis exception\11

when the human dietary risk from a pesticide's residues was, at most,
negligible.  In practice, as previously noted, EPA has generally
defined negligible risk as an incremental increase in lifetime risk
of 1 in 1 million or lower, as calculated according to a conservative
risk-assessment methodology.\12 This methodology estimates
theoretical rather than actual risk. 


--------------------
\10 The National Academy of Sciences committee concluded that a
negligible-risk standard consistently applied to raw and processed
foods "could give EPA the flexibility needed to reduce dietary
oncogenic risks over time [and] .  .  .  (assuming no consideration
of benefits) could lead to the elimination of 98 percent of existing
dietary risk from exposure to the 28 pesticides comprising the
committee's estimate of dietary oncogenic risk.  In contrast, a
zero-risk standard applied only to oncogenic residues in processed
foods and their parent raw commodities would reduce estimated risk by
just 55 percent." Regulating Pesticides in Food:  The Delaney
Paradox, National Academy of Sciences (Washington, D.C.:  1987), p. 
13. 

\11 The legal doctrine of de minimis means that the law does not care
for or take notice of very small or trifling matters. 

\12 To calculate potential risk, EPA multiplies estimated exposure
levels by estimated hazard levels.  To estimate dietary risk, EPA
evaluates data on the nature and amount of pesticide residue that can
be expected to remain in food, the types and amounts of foods in the
diet (exposure), and the toxic effects of the residue (hazard).  In
assessing dietary risk, EPA considers each pesticide separately and
considers only exposure from food (and not from other sources, such
as air and water).  EPA often incorporates several worst-case
assumptions--that, for example--pesticide residues are present at the
published tolerance level (maximum legal level) and 100 percent of
the acreage of a crop that could be treated with a pesticide will be
treated.  Some people believe that the uncertainties in risk-
assessment methodology and the pesticide-by-pesticide assessment
significantly underestimate risk.  Others believe that this
methodology substantially overestimates risk. 


   THE COURT OVERRULED EPA'S DE
   MINIMIS POLICY
------------------------------------------------------------ Letter :5

In attempting to implement the de minimis policy, EPA encountered
resistance from environmentalists, labor organizations, and certain
state officials.  In May 1989, several parties filed a petition
requesting EPA to revoke 14 section 409 tolerances for seven
pesticides\13 on the grounds that these pesticides were carcinogenic
to animals and therefore their uses violated the Delaney clause.  The
agency agreed to revoke a few of the section 409 tolerances, reserved
judgment on some, and denied the petition for others on the basis of
the de minimis policy. 

In July 1992, the Ninth Circuit Court of Appeals overturned EPA's de
minimis interpretation, concluding that, under the Delaney clause,
once evidence of carcinogenicity is found, EPA has no discretion to
apply a de minimis interpretation and therefore cannot allow a
section 409 tolerance.  In February 1993, the Supreme Court declined
to review this case; hence, the court of appeals' ruling stands. 
Unless the Congress amends section 409 of FFDCA, EPA will implement
the court of appeals' decision on the Delaney clause. 


--------------------
\13 Trifluralin, benomyl, phosmet, mancozeb, dicofol, dichlorvos
(DDVP), and chlordimeform. 


   EPA EXPECTS THE COURT'S
   DECISION TO PROVE COSTLY
------------------------------------------------------------ Letter :6

While environmental, labor, and consumer groups view the Les decision
as a victory for public health, EPA anticipates that its effects will
prove costly.  In July 1993, EPA issued a revocation notice for the
section 409 tolerances cited in the court's decision, but the
effective date of these revocations was automatically delayed by
requests for administrative hearings and stays.  As of March 1994,
the agency had not applied its own coordination policy and proposed
the revocation of the section 408 tolerances for the associated raw
foods.  According to the agency, the Les decision will ultimately
require it to revoke tolerances for about 30 pesticides--with
approximately 100 raw and processed food uses--unless it revises its
remaining administrative policies.  These pesticides include benomyl,
which is used on apples, and triadimefon, which is used on barley. 
Appendix III lists the pesticides and uses that may be revoked. 

In EPA's view, a literal implementation of the court's decision could
hinder the agency's ability to ensure the safety and affordability of
the food supply.  In addition, placing so much emphasis on the
relatively small dietary risk of cancer tends to obscure potentially
more serious risks, such as risks to workers and the environment. 
The total impact of the Les decision will depend greatly on how EPA
applies its administrative policies.  According to the agency, the
loss of the affected, currently registered pesticides could decrease
the volume, quality, and variety of the agricultural crops grown in
the United States.  How long these effects might last is unknown. 
The production of minor crops\14 --such as apples and grapes--which
now depends heavily on the use of pesticides subject to the Delaney
clause (i.e., benomyl and dicofol), is expected to suffer the most,
since alternatives to these pesticides may be limited.  Hence, the
loss of these pesticides could increase the prices of some foods and
decrease the availability of a nutritional and varied food supply for
consumers. 

At the same time, according to EPA, the revocation of existing
pesticide uses could affect incomes in the agricultural community,
causing economic dislocations in certain parts of the country as well
as geographical shifts in the production of certain crops, as the
following example shows:  A crop grown in several regions of the
United States may be exposed to different pests in different regions. 
If a pesticide used to control pests in one region is eliminated,
then production of the crop in that region may suffer.  As a result,
production of the crop may increase in other regions to overcome this
shortfall. 

Although EPA has not formally estimated the economic costs to
consumers and the agricultural community of losing these pesticides,
it has stated preliminarily that the costs could be significant.  EPA
officials suggest that, in almost all cases, the economic effects on
users of losing a specific pesticide are minimized within 3 to 5
years. 

According to representatives of pesticide manufacturers and food
processors, the loss of some pesticides could increase risks to
public health by increasing consumers' exposure to (1) naturally
occurring toxins whose growth is currently inhibited by certain
fungicides for which weak evidence of human carcinogenicity has been
found and (2) noncarcinogenic alternatives that pose other--sometimes
greater--risks, such as the risk of birth defects or neurological
damage.  Furthermore, according to EPA, strict interpretation of the
Delaney clause--which applies only to carcinogenic pesticide residues
that are concentrated in or added to processed foods--could
discourage the development, registration, and use of safer new
pesticides.  For example, if pesticide X posed a lower risk of cancer
in raw foods than pesticide Y but pesticide X was concentrated in
processing, pesticide X would not receive a section 409 tolerance--no
matter how negligible the potential risk of cancer it posed. 
Although pesticide Y might pose a greater potential risk of cancer,
it would not require a section 409 tolerance because it was not
concentrated during processing.  Thus, if pesticide Y met the
standards in FIFRA and FFDCA section 408, it could be registered for
food use, while, under the Delaney clause, the lower-risk pesticide,
pesticide X, could not.\15

According to consumer, labor, environmental, and public health
organizations, which argue that the use of pesticides can jeopardize
public health, the loss of carcinogenic pesticides would reduce
consumers' exposure to harmful chemicals and thereby improve food
safety and public health.  In addition, these organizations believe
that the cancellation of hazardous pesticides could accelerate the
development of safer pesticides.  According to these organizations,
adopting safer methods of pest management, such as alternative
agricultural practices, could reduce the use of pesticides and
further decrease consumers' exposure to carcinogens.  Furthermore,
they contend that the economic impacts of cancelling these pesticides
are overstated. 


--------------------
\14 Minor crops are generally considered to be those crops for which
the sales of a pesticide may not be judged to warrant the expense of
maintaining an existing registration or establishing a new
registration, and they include specialty crops, such as fruits and
vegetables.  In 1990, U.S.  agricultural sales for minor crops
totaled approximately $30 billion. 

\15 Similarly, if pesticide Z posed small, yet greater
noncarcinogenic risks (of, for example, reproductive effects or birth
defects) than pesticide X and if pesticide Z was not concentrated in
food processing and met the standards in FIFRA and FFDCA section 408,
then pesticide Z could be registered for food use.  Under the Delaney
clause, the safer pesticide, pesticide X, could not be registered for
use in a processed food in which the pesticide's residues were
concentrated above the level allowed on the raw food. 


   MODIFYING ADMINISTRATIVE
   POLICIES WOULD NOT RESOLVE
   DIFFERENCES
------------------------------------------------------------ Letter :7

To mitigate what it sees as the negative effects of the Les decision,
EPA could modify its remaining administrative policies, but such
modification could not resolve the legal differences that first led
the agency to develop the policies.  For instance, if EPA abandoned
its coordination policy, it would not have to revoke the section 408
tolerances for those pesticide uses whose section 409 tolerances the
court found in violation of the Delaney clause.  Thus, for example,
if EPA abandoned the coordination policy, it could retain the section
408 tolerance for the use of a pesticide on raw apples even after it
had revoked the section 409 tolerance for the use of the same
pesticide in apple pomace.\16

Similarly, EPA could modify its concentration and ready-to-eat
policies by altering the threshold for concentration and thereby
relaxing or tightening regulatory standards.  For example, EPA could
decide that concentration in the range of 5 percent--or of 15
percent--was just cause for requiring a section 409 tolerance.  Or it
could set higher tolerances for pesticide residues in foods that it
assumed would be combined in specified proportions with other
ingredients.  But changes in the standard of concentration--from a
flexible range to a single numerical standard--would be arbitrary,
and changes in the ready-to-eat policy could not cover all
contingencies and, according to EPA, would be virtually impossible to
administer and enforce.  Moreover, such changes could not alter the
fact that, under the "flow-through" provision of FFDCA (section 402),
comparison with a raw food tolerance (which could have been
established through a consideration of risks and benefits), rather
than evaluation based on a uniform standard of risk, drives the
regulation of pesticide residues in processed foods. 

Even though administrative changes will not resolve the varying
requirements in the federal pesticide laws, the Les decision has
fueled the demand for EPA to modify its remaining administrative
policies.  In September 1992, for example, the National Food
Processors Association filed a petition with the agency, asking it to
reassess its coordination policy in order to forestall the perceived
negative effects of implementing the court's decision.  The petition
seeks recision of EPA's concentration and coordination policies on
the grounds that these policies are inconsistent with the
flow-through provision of FFDCA.  According to the association, FDA
and industry data demonstrate that actual pesticide residue levels in
agricultural commodities and in processed food are well below the
levels set in section 408 tolerances.  Furthermore, according to the
association, food processors employ good manufacturing practices that
ensure the compliance of finished products with the flow-through
provision. 

Similarly, although EPA has argued that changes in its ready-to-eat
policy would be difficult to administer, the National Food Processors
Association filed a petition in May 1993 with FDA, which is
responsible for enforcing pesticide tolerances, to provide for what
the association believes is the proper application of the
flow-through provision.  The petition asks FDA to recognize that a
concentrated processed food that is not ready to eat is legal so long
as ready-to-eat foods made from the concentrated product contain
lower levels of a pesticide's residues than are specified in the
applicable section 408 tolerance.  The petition requests FDA to
prescribe appropriate concentrations for reconstituted processed
ingredients on the basis of the ingredients' customary use in
finished foods.  It also requests FDA to issue a tolerance or action
level under section 406 of FFDCA for a pesticide's residues in a
ready-to-eat processed food that exceed the tolerance for the raw
product but pose an acceptable health risk. 

Meanwhile, environmental, labor, consumer, and public health groups
have opposed any weakening of the remaining policies.  They contend
that EPA's policy of denying section 408 tolerances for pesticides
that cannot receive section 409 tolerances is sound public policy
consistent with federal statutes.  According to an EPA official, as
of March 1994, EPA had not determined whether it would revise its
administrative policies in light of the Les decision. 


--------------------
\16 The economic impact of abandoning the coordination policy is not
clear.  Such a change in EPA's policy might reduce the economic
impact of the court's decision on pesticide manufacturers, growers,
and consumers because it would continue to allow the use of the
affected pesticides on raw food.  However, it could increase the
likelihood that food processors would unknowingly produce adulterated
food.  According to an EPA official, the market might create some
rough equivalent of the coordination policy if farmers and processors
reacted to the possibility that processed food might be adulterated
by simply refusing to accept foods containing pesticides for which
section 409 tolerances had been denied or revoked. 


   THE CONGRESS COULD AMEND THE
   FEDERAL PESTICIDE LAWS
------------------------------------------------------------ Letter :8

The Congress alone has the authority to amend the federal pesticide
laws to establish a single regulatory standard for pesticide residues
on or in raw commodities and processed foods.  Policy options
considered by the Congress range from taking no legislative action to
amending the laws to both resolve their differences and extend their
scope.  In broad terms, options for amending the laws include (1)
allowing zero risk of cancer (providing for a phaseout of the most
dangerous pesticides) with no consideration of benefits, (2) allowing
negligible dietary risks with no consideration of benefits, and (3)
allowing negligible dietary risks with limited consideration of
benefits.  If the Congress decides to amend the laws, its choice of a
regulatory standard will depend on its determination of (1) how much
risk, if any, is appropriate and (2) whether and how benefits, and
which benefits, should be considered and for what time period.  The
legislation proposed by the administration in April 1994 would allow
only negligible risks, with limited consideration of benefits during
a transitional period after the law's enactment.  The proposed
legislation would also mandate consideration of some factors that the
current laws do not specifically address, such as risks to infants
and children. 


      TAKING NO LEGISLATIVE ACTION
      WOULD PERPETUATE EPA'S
      REGULATORY DILEMMA
---------------------------------------------------------- Letter :8.1

If the Congress takes no action, differences in the federal pesticide
laws will remain, and EPA will have to implement different standards. 
Since the Les decision, EPA has not been able to invoke the de
minimis approach, and it may find that the recent industry petition
asking it to reassess its coordination policy is followed by
lawsuits, no matter how it rules on the petition.  Furthermore, if
both the laws and EPA's remaining administrative policies stay the
same, reductions in the quality and variety of the available food
supply and increases in food prices could occur, as EPA has
indicated. 


      A ZERO-RISK STANDARD WOULD
      ELIMINATE ALL CARCINOGENIC
      USES
---------------------------------------------------------- Letter :8.2

To create a zero-risk standard\17 for pesticide residues on or in
both raw and processed foods, the Congress could amend sections 408
and 409 of FFDCA to be consistent with the Delaney clause.  Under
this option, EPA would have to phase out all food tolerances for any
pesticide found to cause cancer in animals.  For consistency, the
Congress could also amend FIFRA to require the cancellation of all
food uses of all carcinogenic pesticides. 

Proponents of this approach argue that scientific knowledge of the
risks posed by carcinogens is too uncertain to justify allowing any
potential risk.  Although science can determine that a chemical is a
carcinogen, it cannot determine how much exposure to that chemical is
necessary to trigger carcinogenic effects in humans.  Neither can it
definitively determine how that chemical will interact with other
chemicals in the body.  Nor can it measure delayed or long-term
effects with sufficient accuracy to determine how much exposure to a
chemical poses no risk of cancer.  Therefore, according to advocates
of a zero-risk standard or carcinogenic phaseout, there is no
scientific basis for categorizing any carcinogenic exposure as a
"trivial" or "negligible" risk, and there is no justification for
intentionally adding any carcinogen to food.  According to proponents
of the zero-risk standard, the current regulatory system's admission
of "negligible" or "acceptable" levels of risk may permit the use in
food of chemicals that cause thousands of extra cases of cancer per
year.  Until more is known about the carcinogenic effects of
chemicals on humans, proponents believe, a zero-risk standard is
necessary to protect public health. 

Opponents argue that implementing a zero-risk standard would create
the same negative effects as implementing the Les decision in
conjunction with EPA's administrative policies.  Such a standard
would negatively affect the cost and availability of foods, afford no
opportunity for considering the benefits of pesticides to public
health, and could create international trade difficulties.  Opponents
further argue that a zero-risk standard would be impracticable and
costly to implement.  The term "zero risk" is itself misleading, they
believe, because the results of scientific tests are too uncertain to
prove definitively that no risk exists.  Furthermore, the meaning of
the term shifts constantly as testing methods improve.  Today, tests
are far more sensitive than they were in 1958 when the Delaney clause
was written, and scientists are now able to detect traces of residue
in concentrations of parts per billion and smaller.  Although,
according to opponents, these traces pose virtually no threat to
public health, EPA is obliged to prohibit the presence of
carcinogenic residues, regardless of risk, when the Delaney clause
applies.  According to the National Academy of Sciences, EPA has
focused considerable resources on assessing carcinogenic risk. 


--------------------
\17 As previously noted, the term "zero risk," as used in this
report, means no intentional addition of carcinogens to food. 


      A NEGLIGIBLE-RISK STANDARD
      WOULD ALLOW EPA TO EVALUATE
      CARCINOGENIC RISKS
---------------------------------------------------------- Letter :8.3

To create a single negligible-risk standard for carcinogens, the
Congress could amend FFDCA so that the same standards would be
applied to both raw and processed commodities.  According to the
National Academy of Sciences, the application of such a standard to
all pesticides and all forms of food could dramatically reduce the
total dietary exposure to carcinogenic pesticides and only marginally
reduce benefits. 

Proponents contend that the consistent application of a
negligible-risk standard to raw and processed foods would allow the
United States to continue producing a safe, economical, and abundant
food supply.  It would improve the federal regulation, and reduce the
risks, of pesticide use by focusing limited regulatory resources on
the crop and pesticide combinations presenting the greatest risks.  A
negligible-risk standard applied to all uses would allow EPA to
discriminate between relatively significant and relatively
insignificant carcinogenic risks, and it would give the agency the
flexibility to replace more carcinogenic with less carcinogenic
pesticides, thereby enabling it to reduce consumers' overall exposure
to carcinogens in the diet.  In addition, pesticides posing minimal
carcinogenic risks could replace other pesticides that pose higher
risks to health and the environment but are not carcinogenic. 

The term "negligible risk" could be defined in strictly numerical or
in narrative terms.  A numerical, or "bright line," definition would
require EPA to apply a specific measure--such as a theoretical
incremental increase in the lifetime risk of cancer of 1 in 1 million
people--to all pesticide uses on all commodities and could require
EPA to use a specific methodology.  A narrative, or "fuzzy line,"
definition would give EPA the flexibility, in setting tolerances, to
use the most up-to-date methods of assessing risk as these evolve
with changes in scientists' understanding of carcinogenic risk. 

Proponents of a bright line standard believe that it would give
consumers the best assurance that food is safe.  Since a bright line
standard would require the agency to reevaluate existing pesticide
uses against a numerical legal standard, proponents argue, it would
provide a consistent basis for measuring carcinogenic risk and would
help to protect EPA against litigation, manipulation, and political
pressure.  According to proponents, the adoption of a bright line
standard would not deny EPA the right to choose the methodology for
conducting risk assessments, nor would it prevent the agency from
modifying the assumptions it used to conduct risk assessments in
keeping with scientific developments. 

Proponents of a narrative definition of negligible risk believe that
regulators should be given the flexibility to set tolerances on the
basis of evolving science, not on the basis of a number--considered
arbitrary by some--codified into law at a specific time. 
Furthermore, they argue, setting a numerical standard would suggest
that risk assessment is a more exact science than it is.  According
to proponents, a fuzzy line would be more consistent with the actual
variation in the quality of the data that are available to EPA in
assessing risks.  For example, existing data may not adequately
demonstrate the quantities and toxicological effects of pesticide
residues.  Moreover, according to proponents, a narrative standard
would give EPA the discretion to use the most up-to-date
risk-assessment procedures and to take into account the fact that
scientists believe, in some cases, that quantitative risk assessment
is not appropriate. 

Opponents of a negligible-risk standard support a zero-risk standard,
or an ultimate phaseout of carcinogens.  They contend that a
negligible-risk standard unnecessarily exposes people to
cancer-causing substances and fails to create incentives for
developing safer alternatives.  As previously noted, opponents argue
that no risk can be deemed "acceptable" or "negligible" because too
little is known about when or in what dosage a carcinogen causes
cancer.  Hence, opponents believe that carcinogens should not
intentionally be added to the food supply. 


      CONSIDERING BENEFITS IN
      CONJUNCTION WITH A
      NEGLIGIBLE-RISK STANDARD
      WOULD GIVE EPA GREATER
      FLEXIBILITY
---------------------------------------------------------- Letter :8.4

To allow EPA to consider benefits in conjunction with a
negligible-risk standard, the Congress could amend section 409 of
FFDCA to be consistent with section 408 and FIFRA, both of which
require EPA to consider specified types of benefits.  This policy
option could give EPA the flexibility to consider the economic as
well as the health and ecological effects of its regulatory
decisions. 

Proponents of considering benefits argue that, by killing weeds and
insects, pesticides help farmers produce a varied, abundant,
affordable, and dependable food supply.  Thus, pesticides provide
nutritional and economic benefits to consumers.  It is these
benefits, as distinct from industry profits, that should be
considered in regulating pesticides, proponents maintain. 

Opponents of considering benefits argue that the practice allows
economic rather than health concerns to dominate the regulatory
process.\18 They believe that, under the current system, benefit
assessments create a "loophole" that could permit the use of
pesticides whose tolerances exceed negligible-risk standards.  For
example, if removing a pesticide from the market would create an
economic loss, then a benefit assessment might provide a rationale
for keeping the risky pesticide on the market.  Thus, according to
opponents, consumers' health could receive lower priority than
agricultural practices when benefits were assessed. 


--------------------
\18 For example, the National Academy of Sciences argued in 1993
that, to "ensure that infants and children are not exposed to unsafe
levels of pesticide residues .  .  .  EPA [should] modify its
decision-making process for setting tolerances so that it is based
more on health considerations than on agricultural practices.  These
changes should incorporate the use of improved estimates of exposure
and more relevant toxicology, along with continued consideration of
the requirements of agricultural production.  As a result, human
health considerations would be more fully reflected in tolerance
levels." Pesticides in the Diets of Infants and Children, National
Academy of Sciences (Washington, D.C.:  1993), p.  8. 


      THE ADMINISTRATION HAS
      PROPOSED LEGISLATION TO
      REFORM THE FEDERAL PESTICIDE
      LAWS
---------------------------------------------------------- Letter :8.5

In April 1994, the administration proposed legislation outlining
legislative reforms and administrative initiatives to improve food
safety, protect human health and the environment, and establish a
consistent framework for making timely regulatory decisions.  The
proposed legislation calls for, among other things, amending FFDCA to
require EPA to set tolerances for pesticide residues in all types of
food in accordance with a strong, health-based safety standard.  This
standard would require reasonable certainty of no harm to consumers
and negligible risk for carcinogens.  According to an EPA official,
EPA does not want legislation to specify a bright line numerical
standard for negligible risk in the statute because such a standard
could, like the Delaney clause, become outdated as science evolves. 
Under the administration's proposal, benefits could be considered in
some instances when existing tolerances exceeded the negligible-risk
standard.  However, these tolerances could be continued for a limited
time (up to 5 years, or 10 years after the law's enactment, whichever
is earlier) when needed to avoid a significant disruption in the food
supply or the loss to consumers of direct health benefits. 

However, an EPA official told us that although the administration's
proposal would allow EPA to consider benefits in determining whether
pesticides could be registered under FIFRA, it would limit the
agency's consideration of benefits in setting tolerances for
pesticide residues under FFDCA.  According to EPA, benefits are and
would be considered under FIFRA mainly for pesticides that were not
used on foods.  Regulatory decisions for food-use pesticides would be
made primarily under FFDCA.  EPA officials acknowledged that any
legislative reform would need to clearly link actions under FFDCA and
FIFRA to avoid any differences between the two statutes. 

Besides seeking to resolve differences in the existing federal
pesticide legislation, the administration's proposal addresses a
number of issues related to establishing pesticide tolerances.  The
proposal would direct EPA to

  consider the impact of exposure to pesticides from multiple
     sources, such as food, air, and water;

  publish specific findings showing that tolerances protect infants
     and children;

  assess the impact of exposure to multiple pesticides that cause the
     same health effect;

  consider food distribution patterns and risks to potentially
     sensitive subpopulations;

  encourage the development and use of less toxic pesticides, methods
     of pest control, and agricultural practices; and

  review all existing tolerances to ensure that they meet the new
     health-based safety standard. 


      THE CHOICE OF A REGULATORY
      STANDARD WILL DEPEND ON
      VALUES
---------------------------------------------------------- Letter :8.6

If the Congress decides to amend the federal pesticide laws, its
choice of a policy option is likely to depend ultimately as much on
policy judgments and decisions as it does on science.  As we have
demonstrated in other reports,\19 both risk and benefit assessments
rely on uncertain data and assumptions, and efforts to balance risks
and benefits require weighing public health and economic interests as
well as evaluating data.  Hence, the Congress's choice of a policy
option--and of an appropriate standard for regulating
pesticides--will require agreement on policy as well as scientific
issues. 


--------------------
\19 For information on risk assessments, see Pesticides:  Pesticide
Reregistration May Not Be Completed Until 2006 (GAO/RCED-93-94, May
21, 1993) and Pesticides:  EPA's Formidable Task to Assess and
Regulate Their Risks (GAO/RCED-86-125, Apr.  18, 1986).  For
information on benefit assessments, see Pesticides:  Better Data Can
Improve the Usefulness of EPA's Benefit Assessments (GAO/RCED-92-32,
Dec.  31, 1991).  See also Food Safety:  Difficulties in Assessing
Pesticide Risks and Benefits (GAO/T-RCED-92-33, Feb.  26, 1992). 


   CONCLUSIONS
------------------------------------------------------------ Letter :9

The administrative policies that EPA developed to reconcile
differences in the federal pesticide laws have been and may again be
challenged in court.  If these laws remain unchanged and if EPA
retains the coordination policy and other remaining policies, the Les
decision may compel the revocation of tolerances for a large number
of pesticide uses.  If the laws remain unchanged and if EPA revokes
its remaining policies, fewer tolerances would have to be revoked. 

Amending the federal pesticide laws to establish a single standard
for regulating pesticide residues in or on all foods would give EPA a
coherent basis for setting tolerances and would allay controversy
over the agency's implementation of the pesticide laws.  What that
standard should be--how much risk it should allow and whether it
should permit the consideration of benefits--is a question that
science cannot yet answer definitively.  Although scientists have
improved their ability to detect pesticide residues and assess risks,
they cannot determine exactly how much risk these residues pose,
either alone or in combination with other environmental effects. 
Therefore, at this time, decisions about whether to allow residues of
carcinogenic pesticides in food are, ultimately, policy
judgments--judgments that the Congress may be called upon to make in
reauthorizing FIFRA and amending FFDCA.  A clear resolution of the
differences in the federal pesticide laws would help to avoid
recurring regulatory difficulties and disputes. 


   AGENCY COMMENTS
----------------------------------------------------------- Letter :10

In written comments on a draft of this report, which appear in
appendix IV, EPA concurred with our conclusions.  Under separate
cover, EPA provided technical clarifications that we incorporated
into this report where appropriate.  We also incorporated comments
from panelists who participated in a symposium on pesticide issues
that we sponsored on July 20, 1993. 


   SCOPE AND METHODOLOGY
----------------------------------------------------------- Letter :11

We conducted our review from June 1993 to April 1994.  To accomplish
our objectives, we collected and reviewed data from federal agencies
and from industrial, environmental, and other nonprofit
organizations.  We interviewed officials from EPA.  Also, as noted,
we sponsored a symposium on July 20, 1993, for experts on pesticide
issues from federal agencies, environmental groups, and industry
groups to discuss options for resolving differences in the federal
pesticide laws.  The five panelists were Jay Feldman, Executive
Director, National Coalition Against the Misuse of Pesticides; Rick
Jarman, Director, Technical Regulatory Affairs-EPA, National Food
Processors Association; William L.  Jordan, Deputy Director, Policy
and Special Projects Staff, Office of Pesticide Programs,
Environmental Protection Agency; John McCarthy, Vice President,
Global Scientific and Regulatory Affairs, National Agricultural
Chemicals Association; and Erik D.  Olson, Senior Attorney, Natural
Resources Defense Council. 


--------------------------------------------------------- Letter :11.1

We are sending copies of this report to interested congressional
committees and to the Administrator, EPA.  We will make copies
available to others on request. 

This work was performed under the direction of Peter F.  Guerrero,
Director, Environmental Protection Issues, who can be reached at
(202) 512-6111.  Other major contributors to this report are listed
in appendix V. 

Keith O.  Fultz
Assistant Comptroller General

List of Addressees

The Honorable Patrick J.  Leahy
Chairman
The Honorable Richard G.  Lugar
Ranking Minority Member
Committee on Agriculture,
 Nutrition, and Forestry
United States Senate

The Honorable Edward M.  Kennedy
Chairman
The Honorable Nancy L.  Kassebaum
Ranking Minority Member
Committee on Labor and Human Resources
United States Senate

The Honorable E (Kika) de la Garza
Chairman
The Honorable Pat Roberts
Ranking Minority Member
Committee on Agriculture
House of Representatives

The Honorable John D.  Dingell
Chairman
The Honorable Carlos J.  Moorhead
Ranking Minority Member
Committee on Energy
 and Commerce
House of Representatives


PROVISIONS OF FEDERAL LAWS
REGULATING PESTICIDES
=========================================================== Appendix I

Law/provision              Regulates                  Purpose/effect
-------------------------  -------------------------  --------------------------
FIFRA                      Pesticide uses             Register specified uses of
                                                      pesticide products on the
                                                      basis of both risks and
                                                      benefits. Pesticide may
                                                      not cause any unreasonable
                                                      risk to man or the
                                                      environment, taking into
                                                      account the economic,
                                                      social, and environmental
                                                      costs and benefits of the
                                                      use of the pesticide.

FFDCA                      Pesticide residues in or   Limit the amount of
(specified sections)       on foods                   pesticide residue in or on
                                                      raw agricultural
                                                      commodities, processed
                                                      foods, or animal feed.

Section 408                Pesticide residues on raw  Protect human health while
                           agricultural commodities   allowing for the
                           (raw foods). Requires a    production of an adequate,
                           tolerance (legal limit on  wholesome, and economical
                           the amount of pesticide    food supply.
                           residue allowed) or
                           tolerance exemption.

Section 409 (includes      Pesticide residues         Protect human health by
Delaney clause, sec.       (classified as food        requiring that proposed
409(c)(3)(A))              additives) in processed    use will be safe. Delaney
                           foods. Requires a          clause establishes a
                           tolerance when the level   strict "zero-risk"
                           of residue exceeds that    standard for carcinogenic
                           prescribed in the section  pesticide residues in
                           408 tolerance for the raw  processed food.
                           agricultural commodity.
                           Under the Delaney clause,
                           no food additive
                           tolerance may be granted
                           for a pesticide found to
                           induce cancer in humans
                           or animals. (Certain
                           exceptions are made for
                           animal feed.)

                           Also regulates pesticides
                           applied during or after
                           processing.

Section 402                Adulterated food.          Permit the use of certain
                                                      products for which a
                           Provides that a raw food   section 409 tolerance
                           is adulterated if it       could not be obtained.
                           contains a pesticide       Under the flow-through
                           whose residues are not     provision of section
                           authorized by a section    402(a)(2)(C), the use of a
                           408 tolerance or           pesticide containing a
                           exemption.                 minute quantity of a
                                                      carcinogenic ingredient
                           Requires a section 409     could be allowed, whereas,
                           tolerance for a pesticide  under the Delaney clause,
                           (1) whose residues are     this use would be
                           concentrated above the     prohibited.
                           section 408 tolerance in
                           processed food that is     Since the term "ready to
                           "ready to eat" or (2)      eat" has not been defined,
                           that is added to the       the concentration
                           processed food during or   requiring a section 409
                           after processing.          tolerance is uncertain.
                           (Without a tolerance, the
                           processed food is
                           considered adulterated.)

                           The "flow-through"
                           provision, section
                           402(a)(2)(C), exempts a
                           pesticide from the
                           requirement for a section
                           409 tolerance when the
                           pesticide's residues in a
                           processed food that is
                           "ready-to-eat" are not
                           concentrated above the
                           tolerance prescribed in
                           section 408 for the same
                           raw food.
--------------------------------------------------------------------------------

DIFFERENCES IN FEDERAL LAWS
REGULATING PESTICIDES
========================================================== Appendix II

                                        Balances risks and  Permits controlled
Legal provision     Regulates           benefits            use of carcinogens
------------------  ------------------  ------------------  --------------------
FIFRA               Pesticide uses      Yes                 Yes

FFDCA (specified    Pesticide residues  Under some          Under some
sections)           on or in foods      conditions          conditions

Section 408         Pesticide residues  Yes                 Yes
                    on raw
                    agricultural
                    products

Section 409         Pesticide residues  Yes                 Not applicable
(excluding Delaney  in processed food   (according to
clause)             that are            EPA's
                    concentrated above  interpretation)
                    the section 408
                    tolerance

Section 409 -       Carcinogenic        No                  No
Delaney clause      pesticide residues

Section             Pesticide residues  Yes                 Yes
402(a)(2)(C) -      in ready-to-eat
flow-through        processed food
provision           that are not
                    concentrated above
                    the section 408
                    tolerance
--------------------------------------------------------------------------------

PESTICIDE USES POTENTIALLY
AFFECTED BY REVOCATION OF SECTION
409 AND CORRESPONDING SECTION 408
TOLERANCES
========================================================= Appendix III

According to EPA, the registrations for the pesticides and the
tolerances for their uses listed in tables III.1 and III.2 may be
revoked if EPA holds to a strict interpretation of the Delaney
clause.  EPA has not determined that these pesticides "induce cancer"
within the meaning of the Delaney clause but has found, under its
cancer classification guidelines, that the pesticides are potentially
carcinogenic.  As EPA acquires new data through its reregistration
program from tests of pesticides' carcinogenicity and from
food-processing studies, it may include some other pesticides or uses
in these tables, or it may exclude others.  Hence, the tables should
not be considered definitive or final.  The information in the tables
is frequently updated. 

The publication of these tables does not affect the regulatory status
of any of the pesticides or uses cited.  If EPA proposes to revoke
tolerances under FFDCA, it will announce its intention to do so
through regulatory channels, providing notice and seeking comment as
appropriate. 



                         Table III.1
           
           Pesticides With Established Section 409
                   Food Additive Tolerances

                                        Processed food/feed
Registered          Raw crop (408       with 409
pesticide           tolerances)         tolerance(s)
------------------  ------------------  --------------------
Acephate            Cotton              Seed hulls, meal

                    Soybeans            Meal

                    Not applicable      Food handling
                                        establishments

Benomyl\a           Apples              Pomace

                    Citrus              Pulp

                    Grapes\a            Pomace

                                        Raisins\a
                                        (proposed for
                                        revocation)

                                        Raisin waste

                    Rice                Hulls

                    Tomatoes\a          Puree or catsup\a
                                        (proposed for
                                        revocation)

Captan              Grapes              Raisins

Dichlorvos                              Packaged
(DDVP)\a                                nonperishable
                                        food\a,b
                                        (proposed for
                                        revocation)

Dicofol\a                               Dried tea\a,b
                                        (revoked)

Diflubenzuron       Soybeans            Hulls, soapstock

Dimethipin          Cotton              Seed hulls

Dimethoate          Citrus              Pulp

Ethylene oxide      Whole spices        Ground spices

Mancozeb\a          Barley\a            Bran\a

                                        Flour

                                        Milled fractions

                    Grapes\a            Raisins\a (proposed
                                        for revocation)

                    Oats\a              Bran\a

                                        Flour

                                        Milled fractions

                    Rye                 Bran\a

                                        Flour

                                        Milled fractions

                    Wheat\a             Bran\a (proposed for
                                        revocation)

                                        Flour (proposed for
                                        revocation)

                                        Milled fractions

Norflurazon         Citrus              Pulp, molasses

Oxyfluorfen         Cotton              Cottonseed oil

                    Peppermint          Oil

                    Spearmint           Oil

                    Soybean             Oil

Phosmet\a           Cotton\a            Cottonseed oil\a
                                        (proposed for
                                        revocation)

Propargite          Apples              Pomace

                    Grapes              Raisins

                                        Dried pomace

                    Figs                Dried figs

                    Citrus              Pulp

                    Tea                 Dried tea

Propylene oxide                         Cocoa\b

                                        Glace fruit\b

                                        Edible gums\b

                                        Processed nutmeat
                                        (except peanuts)\b

                                        Prunes\b

                                        Processed spices\b

                                        Starch\b

Simazine            Sugarcane           Molasses, syrup

                                        Potable water\b

Tetrachlorvinphos                       Feed items\b

Thiophanate-        Apples              Pomace
methyl

Triadimefon         Apples              Pomace

                    Barley              Milled fractions

                    Grapes              Pomace

                                        Raisin waste

                    Wheat               Milled fractions

Trifluralin\a       Peppermint\a        Oil\a (proposed for
                                        revocation)

                    Spearmint\a         Oil\a (proposed for
                                        revocation)
------------------------------------------------------------
\a Identifies pesticides and uses that have been challenged in the
Les v.  Reilly case. 

\b Identifies commodities that do not have corresponding section 408
tolerances because the pesticide is used only on the processed
commodity. 

Source:  GAO's presentation of information from EPA. 



                         Table III.2
           
           Pesticides That Do Not Have Established
           Section 409 Food Additive Tolerances but
            Would Require Them Under EPA's Current
                           Policies

                    Crop(s) with        Processed food(s)
Registered          section 408         with no section 409
pesticide           tolerance(s)        tolerance(s)
------------------  ------------------  --------------------
Acephate\a          Soybeans\a          Hulls

Alachlor            Peanuts             Meal

                    Soybeans            Hulls, meal

                    Sunflower seed      Meal

Asulam              Sugarcane           Bagasse, molasses

Atrazine            Sugarcane           Bagasse, molasses

Benomyl\a           Rice\a              Bran

                    Soybeans            Hulls

Captan\a            Apples              Dry pomace

                    Grapes\a            Raisin waste, juice,
                                        dry pomace

                    Plums               Prunes

                    Tomatoes            Dry pomace

Chlorothalonil      Soybeans            Hulls

                    Potatoes            Wet peel

Dichlorvos          Not applicable      Food handling
(DDVP)\a                                establishments

Dicofol\a           Apples              Dry pomace

                    Citrus              Oil

                    Grapes              Dry pomace, raisins,
                                        raisin waste

                    Plums               Prunes

Dimethoate\a        Apples              Juice

                    Citrus\a            Oil

Hexazinone          Alfalfa             Meal

                    Pineapple           Bran, molasses

                    Sugarcane           Bagasse, molasses

Lindane             Tomatoes            Dry pomace

Linuron             Potatoes            Dry and wet peel,
                                        dried granules,
                                        chips

                    Soybeans            Meal

Mancozeb\a          Apples              Dry pomace

                    Grapes\a            Raisin waste

                    Sugar beets         Pulp

                    Wheat\a             Middlings

Maneb               Apples              Dry pomace

                    Sugar beets         Pulp

                    Grapes              Raisin waste

Methidathion        Citrus              Oil

Metiram             Apples              Dry pomace

                    Sugar beets         Pulp

Metolachlor         Peanuts             Meal

Methomyl            Wheat               Bran

Norflurazon\a       Citrus\a            Oil

                    Grapes              Raisin waste

Oxyfluorfen\a       Apples              Dry pomace

PCNB                Potatoes            Wet and dry peel

                    Tomatoes            Dry pomace

Permethrin          Tomatoes (limited   Dry pomace
                    to use on tomatoes
                    to be sold fresh
                    in the
                    marketplace)

Phosmet\a           Citrus              Oil

Propargite\a        Citrus\a            Oil

                    Plums               Prunes

                    Grapes\a            Raisin waste

Simazine\a          Sugarcane\a         Bagasse

Triadimefon\a       Pineapple           Bran

Trifluralin\a       Potatoes            Processed potato
                                        waste
------------------------------------------------------------
\a Identifies pesticides and uses that are also included in table
III.1. 

Source:  GAO's presentation of information from EPA. 




(See figure in printed edition.)Appendix IV
COMMENTS FROM THE ENVIRONMENTAL
PROTECTION AGENCY
========================================================= Appendix III


MAJOR CONTRIBUTORS TO THIS REPORT
=========================================================== Appendix V

RESOURCES, COMMUNITY, AND ECONOMIC
DEVELOPMENT DIVISION WASHINGTON,
D.C. 

J.  Kevin Donohue, Assistant Director
Cheryl Goodman, Senior Evaluator
Jennifer Clayborne, Staff Evaluator
Elizabeth R.  Eisenstadt, Reports Analyst

OFFICE OF GENERAL COUNSEL

Doreen Stolzenberg Feldman, Senior Attorney

