Subject: Delaney, EPA version (long)

From: [email-masked] (Thomas Bjorkman)
Date: Tue, 25 Oct 1994 08:20:25 -0500

Last week the PANUPS news relase gave some information about the proposed
new enforcement of the Delaney clause that regulates carcinogens in food. 
(Settlement of California vs Browner).  What follows is the EPA press
release on the subject.  It gives more details of what will happen when,
and the specific Acts and Sections.

PANUPS wears it politics on its sleeve, the EPA's position is a little more
ambiguous.  Carol Browner is a strong advocate for environmental
protection, yet  the EPA lost the lawsuit that seeks stricter enforcement.

   EPA REACHES PROPOSED AGREEMENT ON LAWSUIT CONCERNING PESTICIDES 
   AND THE DELANEY CLAUSE
   
   	   EPA has reached a proposed agreement with plaintiffs in a lawsuit
concerning pesticides and the Delaney clause.  The agreement establishes a
schedule for the Agency that will set policy that could lead to 
cancellation of the uses of 36 pesticides and will lead to further review 
of at least 49 others.

   	   The state of California, the Natural Resources Defense Council and
others sued EPA in l989 over the Agency's application of the Delaney
clause of the Federal Food, Drug and Cosmetic Act.  In certain
circumstances 
this law prohibits residues of pesticides that "induce cancer" from being 
present in processed food. 
   
           "I am pleased that EPA has reached this proposed agreement,
which
continues the Clinton Administration's commitment to reduce pesticide use 
and ensure a safe food supply.  The agreement, however, addresses only one
complex part of the nation's system for safe pesticide management," said 
EPA Administrator Carol M. Browner.  "The Administration believes the 
entire food safety program requires overhaul, and we have already begun
implementing far-reaching administrative reforms and developed a package to
reform current law.  All of our actions and decisions are based on quality
science designed to better protect the health of the American public.
   
   	   "Among our initiatives, for example, are new pesticide safety 
testing procedures designed to be more protective of children, who may be
more susceptible to pesticide risks.  We are working with farmers to 
streamline the process for moving safer pesticides onto the market more
quickly.  And we are working to reduce the total use of pesticides 
nationally.
   
   	   "Our actions and initiatives address not just cancer risks, but 
numerous other health risks, such as reproductive disorders.  And our 
proposal affects not just processed foods, but all foods.  This agreement
assures that America will continue to enjoy the cheapest, most abundant and
safest food supply in the world."  The major terms of the agreement are:
   
   	    -- EPA would agree to rule on a l992 petition of the National
          Food Processors Association (NFPA) within 60 days from the court
          approval of the settlement agreement.  NFPA petitioned EPA among
          other things to discontinue its policy that links processed food
          tolerances with raw food tolerances. Under the Agency's
          "coordination policy," if a processed food tolerance is needed
          but is prohibited under the Delaney clause, the corresponding raw
          food tolerance is not permitted.  For example, prohibition of a
          tolerance on processed tomato puree would also prohibit a
          tolerance on raw tomatoes, because EPA cannot ensure that raw
          tomatoes bearing pesticide residues will not enter processing
          channels and result in residues over tolerance in downstream
          processed tomatoes.  The proposed agreement does not dictate the
          decisions EPA will make on this or other issues raised in
          the NFPA petition, but does set a deadline for making these
          decisions.
   
   	   -- EPA would agree to decide within six months of the court's
   	   approval of the agreement, whether any of approximately 60
   	   processed food tolerances (409s) (earlier identified by EPA as
   	   potentially violating the Delaney clause) violate the Delaney
           clause. Final decisions on revocations would be required within
l8
           months thereafter.
   
   	   -- EPA would agree to decide within 24 months of the court's
   	   approval of the agreement, which of the approximately 80 raw food
   	   tolerances that are associated with existing or needed processed
           food tolerances that may violate the Delaney clause are subject
to
   	   revocation under EPA's coordination policy, as defined in EPA's
   	   response to the NFPA petition.  Final decisions on any proposed
           raw food tolerance (408) revocations must be issued within five
           years of the agreement.
   
   	   -- EPA would agree to review within five years any carcinogenicity
           and processing studies already submitted to the Agency but not
yet
           reviewed to determine if additional processed and raw food
           tolerances are subject to the Delaney clause and must be
revoked.
           If processing data are lacking, EPA must take steps within one
           year to obtain such data.
   
           The Delaney clause in section 409 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) provides that no processed food tolerance may be 
approved for any chemical found to induce cancer in man or animals.  
Pesticides require processed food tolerances only where pesticide residues 
in the processed food either exceed the residues in the raw food or are 
added directly to the processed food.  In l988 EPA adopted a policy
interpreting the Delaney clause as subject to an exception for carcinogenic
pesticides which pose only a negligible risk.  EPA's action under the 
Delaney clause and its negligible risk policy was challenged in two
similar but separate suits.  
   
         In the Les vs. Reilly suit, in July, l992, the plaintiffs 
successfully obtained a "zero risk" interpretation of the Delaney clause 
when the United States Court of Appeals for the Ninth Circuit rejected 
EPA's negligible risk approach to the Delaney clause.  
   
         In California vs. Browner, the subject of the proposed agreement
released today, the parties sought a court order requiring EPA to revoke 
raw food tolerances (section 408) associated with processed food tolerances
(section 409) which are barred by the Delaney clause.  
   
         The proposed agreement between EPA and the California vs. Browner
plaintiffs has been given to the intervenors in the case (American Crop
Protection Association and the National Food Processors Association and 
various grower organizations) for comment and will be submitted to the 
Court on Dec. 2 for approval.  
   
         Obtain copies of the agreement by calling the EPA
Communication  Branch in the Office of Pesticide Programs, 703-305-5017).

-- 
Thomas Bjorkman    Dept. of Horticultural Sciences   Cornell University