Subject: Delaney Clause and Pesticide Tolerances

From: "James C. Wright" <[email-masked]>
Date: 12 Jun 1995 18:55:51 GMT

A press release from EPA follows which should be of interest to anyone 
concerned about the 1992 court order requiring EPA to literally apply the 
Delaney Clause.  If literally applied, the U.S. registrations for many of 
the most commonly-used pesticides will be revoked.

I apologize if the formatting for the press release does not display with 
proper line breaks.  This is how I received it from EPA by e-mail.

James C. Wright
Weinberg, Bergeson & Neuman
1300 Eye Street, N.W., Suite 1000 West
Washington, DC  200005
202-962-8598
[email-masked]

* * *

FOR RELEASE:  FRIDAY, JUNE 9, 1995

               EPA ADOPTS POLICIES GOVERNING TOLERANCE REVOCATION 
                          ACTIONS UNDER DELANEY CLAUSE 

     The U.S. Environmental Protection Agency is adopting policies for 
determining which pesticide residues are covered by the Delaney clause 
which 
prohibits establishment of tolerances for residues of carcinogens in 
processed 
food and animal feed.  These policies will define when concentration of 
pesticide residues occur in processed food and whether a particular 
processed 
food is considered "ready to eat."  

     The modifications are a response to a l992 Delaney clause-related 
petition 
of the National Food Processors Association (NFPA) and others which 
challenged 
some of the Agency's policies regarding pesticide residues in food.  EPA 
was 
required by a court-approved settlement agreement to respond to the NFPA 
petition by today.  Today's new policies are consistent with the laws 
governing 
pesticide residues in food and will serve to clarify EPA's 
decision-making 
criteria for industry and the general public. 

     The NFPA petition asked EPA to address an additional issue, the 
so-called 
coordination policy by which EPA decides how tolerances for fresh fruit 
and 
vegetables (section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA)) are 
affected by revoking tolerances for processed foods (section 409 of 
FFDCA).  The 
EPA has asked the parties to the settlement to approve a modification of 
the 
settlement agreement to postpone issuance of the coordination policy, and 
any 
subsequent revocations of section 408 tolerances (raw food) for about six 
months.  This additional time will allow EPA to work out enforcement and 
other 
issues with the Food and Drug Administration and the U.S. Department of 
Agriculture which may be affected by the action taken today.

     The NFPA petition followed closely a decision by the Ninth Circuit 
Court of 
Appeals (July, l992, Les vs Reilly), which held EPA to a literal 
interpretation 
of the Delaney clause and rejected the Agency's negligible risk policy to 
address pesticides which may be affected by the Delaney clause.  The 
court said 
that the Delaney clause prohibits the establishment of a tolerance or 
legal 
residue level in processed foods for pesticides that induce cancer in 
humans or 
animals, even if the risks are negligible.  

     The action taken today does not immediately impact any specific 
pesticides 
or crops.  However, EPA will be using these policies as it makes 
decisions to 
establish or reassess individual pesticide tolerances.  In particular, 
the 
Agency will be using these and possibly other policies to guide its 
decisions as 
it implements the February l995 court-approved settlement agreement 
between the 
Agency and the Natural Resources Defense Council and others concerning 
pesticides that may be affected by the Delaney clause.  This agreement 
set 
timetables for decisions on whether or not to revoke certain tolerances 
of 
approximately 37 pesticides.  As the Agency makes these decisions, EPA 
will 
carefully consider any information relevant to the application of these 
policies 
to individual pesticides and crops.

     Pesticides are regulated by EPA under the Federal Food, Drug, and 
Cosmetic 
Act (FFDCA) and the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA).  
The regulation of allowable residue levels in food is under FFDCA.  The 
Agency 
sets tolerances for pesticide residues remaining on raw food under 
section 408 
of FFDCA.  In some circumstances, pesticides also need tolerances under 
section 
409 of FFDCA.  Section 409 contains the Delaney clause which prohibits 
the 
establishment of tolerances for residues of carcinogens in processed food 
and 
animal feed.  Tolerances for processed food are necessary to prevent food 
>from  
being deemed adulterated when the concentration of the pesticide residue 
in a 
processed food, when ready to eat, is greater than the tolerance 
prescribed for 
the raw agricultural commodity, or if the processed food itself is 
treated or 
comes into contact with a pesticide.

     The NFPA petition asked EPA to establish policies for three specific 
areas 
of the tolerance-setting program:  when concentration of pesticide 
residues 
occur in processed food; when a food is ready to eat; and how to 
coordinate 
regulatory action between the two sections of FFDCA, 408 (governing 
tolerances 
on raw food) and 409 (governing tolerances on processed food).

     EPA will pursue a steady implementation of the Court's 
interpretation of 
the Delaney clause on a specific timetable as outlined in the agreement 
with 
NRDC, including revocation of existing tolerances that violate the 
Delaney 
clause and denial of tolerances for new uses that would be in violation 
of 
Delaney.

CONCENTRATION POLICY.   In the past, EPA has found that a food additive 
tolerance (section 409) is necessary whenever a pesticide concentrates in 
the 
processed food (i.e., the levels in parts per million are greater in the 
processed food than in the raw food).  NFPA raised a number of concerns 
with the 
Agency's traditional approach to determining whether concentration 
occurs.  EPA 
has concluded that modifications can be made to its policy to ensure 
better 
predictions of concentration.  Information from processing studies will 
remain 
the most important information in determining whether concentration 
occurs.  
However, departing from past practice, EPA will also take into account 
information concerning mixing and blending of crops information 
pertaining to 
average residues.

READY TO EAT POLICY.  As mentioned above, under FFDCA a tolerance for 
pesticide 
residues in processed food is only needed under the FFDCA when residues 
in 
ready-to-eat processed food exceed the raw food tolerance.  The NFPA 
petition 
argues that EPA has issued food additive tolerances for foods that were 
not 
ready to eat.  EPA has concluded that its past interpretation of ready to 
eat 
has sometimes been too rigidly applied and modifications can be made so 
that 
food should be considered "ready to eat" if it can be consumed "as is" 
without 
further preparation.  For example, potato chips are ready to eat and mint 
oil is 
not ready to eat.  In light of these more consistent interpretations, in 
some 
cases EPA may revoke the processed food tolerances (section 409) for 
those foods 
and feeds that are considered not ready to eat and put in place different 
regulations so that residues in such foods can be legally distributed and 
their 
residues appropriately monitored.  Similarly, EPA intends to apply the 
"ready to 
eat" policy to animal feeds. 

COORDINATION POLICY.   The Agency is not today responding to the 
coordination 
policy issue.  Under this policy, if a processed food tolerance cannot be 
established or maintained, then the Agency would also deny or revoke the 
raw 
food tolerance and deny or cancel the registration of the pesticide.  For 
example, if a carcinogenic pesticide, legally used on apples under the 
risk/benefit provisions of FIFRA, would concentrate in apple juice (thus 
requiring a food additive tolerance under section 409), under the Delaney 
clause 
EPA would be required to revoke the food additive tolerance and would 
revoke the 
corresponding raw food tolerance as well.  The reason for this approach 
to 
coordination has been simple:  farmers who properly treat their crops 
with 
approved pesticides should be able to confidently market their products 
without 
risk of condemnation and seizure by the Food and Drug Administration, 
which 
monitors food.  

     NFPA asked EPA to reverse this policy, arguing that growers and food 
processors could assure that residues in processed foods would not exceed 
residues in raw commodities.

ECONOMIC IMPACT ASSESSMENT.  Under the new policies announced today, a 
number of 
pesticide uses are likely to continue to need section 409 tolerances.  
Thus, the 
Delaney clause may result in some pesticide uses being barred.  Prior to 
these 
policy modifications, EPA had prepared a worst-case economic impact 
assessment 
that assumed all potentially-affected pesticide uses would be barred.  
The 
worst-case assessment estimated impacts of up to $500 million on 
agricultural 
producers and processors.  

     Given the changes announced today, EPA believes that this worst-case 
economic assessment overestimates potential impacts because the universe 
of 
potentially affected tolerances will be changed.  The Agency will be 
better able 
to judge impacts as it applies these revised policies to the decisions on 
food 
additive tolerances now scheduled for later this summer.  EPA expects to 
factor 
the results of these decisions made today into the decisions on the 
coordination 
policy.  

     EPA's response is expected to be published in the Federal Register 
within 
the next 10 days.  Reporters can obtain a copy by calling Al Heier at 
EPA's 
Press Office (202-260-4374).  Others can obtain copies by calling the 
Office of 
Pesticide Communications:  703-305-5017. 

                                R-110#    #    #