MCFA

Minor Crop Farmer Alliance

September 22, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

> Re: Docket No. 2003D-0263. Draft Guidance for Industry: Channels of
> Trade Policy for Commodities With Residues of Pesticide Chemicals for
> Which Tolerances Have Been Revoked, Suspended, or Modified by the
> [Environmental Protection Agency -- 68 Fed. Reg. 43535-38. July 23,
> 2003.]{.underline}

To Whom It May Concern:

These comments are submitted by the Minor Crop Farmers Alliance ("MCFA")
in response to the subject draft Guidance proposed by the Food and Drug
Administration ("FDA" or "Agency"). MCFA is an alliance of more than one
hundred national and regional organizations and individuals representing
growers, shippers, packers, handlers and processors of various
agricultural commodities, including food, fiber, nursery and
horticultural products, and organizations involved with public health
pesticides. MCFA has been substantially involved in various issues
involving pesticides and implementation of the Food Quality Protection
Act of 1996 ("FQPA").

The MCFA is also a member of the Implementation Working Group ("IWG")
which has submitted comments on the draft Guidance. Those comments are
extremely comprehensive in identifying potential problems with the draft
Guidance. Consequently, the MCFA endorses those comments and offers
these additional, supplemental comments for the Agency's consideration.

As MCFA has previously advised both FDA and the U.S. Environmental
Protection Agency ("EPA"), it is extremely important that both FDA and
EPA operate in a manner to minimize the potential disruption to the food
supply of the Nation. Except in those specific instances where EPA has
advised that the consumption of a particular legally treated food over
the duration of its "traditional" life in commerce would pose an
unreasonable dietary risk (which the MCFA believes will be extremely
rare occurrences), both FDA and EPA should operate so as to facilitate
the distribution of lawfully treated food. If the FDA wants to preclude
the subsequent distribution of a food that was lawfully treated pursuant
to the EPA‑authorized pesticide label, it is suggested that FDA consider
buying the food in question. The person holding the food at the time of
the FDA action should not be held liable for such regulatory decision
when the pesticide was applied pursuant to a current EPA‑granted
registration that included EPA‑approved directions for use. The easiest
course for all concerned in almost every instance will be to allow the
marketplace to function and allow for such a food containing a pesticide
residue within the previously existing tolerance to be marketed.

MCFA is concerned with the rigor and extent of the database that may
exist for each pesticide residue that may come into question. For
example, it is known that certain pesticide residues may be found in
various crops even though those specific crops have not been treated
with the pesticide. This may likely be the result of uptake of the
pesticide residue by the crop from the soil, such residues in the soil
being present because of a prior application of the pesticide. It is not
clear how such a situation would be handled by FDA. For example, assume
that the pesticide residue would have been within the previously
existing tolerance and the use has been cancelled as well as its
associated tolerance under Section 408 of the Federal Food, Drug, and
Cosmetic Act ("FFDCA"). In this circumstance, such a food is potentially
at risk if the tolerance is prematurely revoked. It may take several
years before such residues in the non‑treated crop are below limits of
quantitation. Both EPA and FDA should be aware of this possibility and
extend the tolerance accordingly. EPA was authorized by the FQPA
(codified at Section 408(l)(4) of the FFDCA) to issue tolerances to
cover these kinds of residues, but EPA has not used this authority. It
would make no sense to take adverse regulatory action prematurely in
such circumstances.

It is also suggested that prior to taking any further action under this
policy, FDA give notice to the interested public of the number of days a
lawfully treated crop may contain detectible residues of the pesticide
at issue. The interested public may then comment on whether the Agency's
assumptions are correct.

MCFA appreciates the opportunity to provide these comments, and looks
forward to the Agency's consideration of them. Please feel free to
contact me if you have any questions, need additional information or
want to discuss this further. I can be reached by telephone at
407-894-1351.

Respectfully submitted,

/s/

Daniel A. Botts

Chairperson, Technical Committee

Minor Crop Farmer Alliance