Delaney Still Applies to Food Additives

        In response to Tiege's question, the FQPA ends the application of
the Delaney Clause to the setting of pesticide tolerance levels.  The law
establishes a new standard, "reasonably certainty of no harm," to tolerance
setting and the review of old tolerances.  In the years before passage of
the FQPA, FDA experts and many others testified that the "reasonable
certainty of no harm" standard is the functional equivalent of how FDA has
been implementing Delaney over the last decade or so in the case of food
additives, animal drugs and in other circumstances where Delaney applies.

        So, the direct answer to your question is that FQPA DID NOT change
Delaney as it applies to other areas of regulation.  There is an enormous
body of administrative and case law on Delaney and additives, with most
precedents set in Red dye # 2 case. 

        While you are correct that another lawsuit could happen involving
FDA, the odds are far less than one-in-one million such a case would be
taking seriously by anyone.  For one thing, the legal and scientific issues
have already been fully litigated in case of FDA actions/food additives, and
secondly, the FQPA "fix" was overtly patterned on FDA interpretation of
Delaney, and the Congress passed it unanimously.  No court is going to
return to these issues again, Congress has spoken with unparalleled clarity
on this matter.  There remain lots of details in implementing provisions in
FQPA that go beyond existing FDA-Delaney policy, especially cumulative
exposure and common modes of action.  These two factors are the reason why
FQPA is going to bring about significant changes in pesticide tolerances and
use, if it is implemented roughly in accord with what the act calls for in
plain english.  Again, everyone expects there to be lawsuits on specific
aspects of the rule-makings EPA is moving forward with, but the law also
requires EPA to move forward, and the political cost to the industry of
tying EPA up on FQPA implementation would be so high I doubt they will even try.

        There is a ton of FQPA related material on our PMAC web site,
www.pmac.net, and the EPA's site also is really excellent, with lots of up
to date information, including the full text of their implementation plan
released in mid-March. OPP/EPA is finally getting its Internet act together. 


Charles Benbrook                         202-546-5089 (voice)
Benbrook Consulting Services             202-546-5028  (fax)
409 First Street S.E.                    benbrook@hillnet.com   [e-mail]
Washington, D.C.  20003                  http://www.pmac.net