[Federal Register: January 5, 2001 (Volume 66, Number 4)]
[Notices]
[Page 1247-1248]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja01-122]
[[Page 1247]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1309]
Final Guidance for Industry: Channels of Trade Policy for
Commodities With Methyl Parathion Residues; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry entitled ``Channels of
Trade Policy for Commodities with Methyl Parathion Residues.'' This
guidance presents FDA's policy for implementing the channels of trade
provision for the pesticide chemical methyl parathion in section
408(l)(5) of the Federal Food, Drug, and Cosmetic Act (the act) as
amended by the Food Quality Protection Act (FQPA) of 1996. The final
guidance is intended to assist firms in understanding FDA's planned
approach to the enforcement of this provision of the FQPA with regard
to residues of methyl parathion in food.
DATES: Submit written comments at any time.
ADDRESSES: Submit written requests for single copies of the final
guidance to the Office of Plant and Dairy Foods and Beverages (HFS-
305), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204. Send one self-
addressed adhesive label to assist that office in processing your
requests. Submit written comments on the final guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-305), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5321, FAX 202-205-4422, e-
mail: mkashtoc@cfsan.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of June 2, 2000 (65
FR 35376), FDA announced the availability of a draft version of this
guidance for industry entitled ``Channels of Trade Policy for
Commodities with Methyl Parathion Residues.'' The agency has finalized
that draft guidance after considering the five comments that were
received on the draft version.
In response to a suggestion in a comment, FDA is specifying in this
final guidance, the method it intends to use to test for methyl
parathion residues in foods. In response to comments asking for
additional time and stating that firms need additional time to prepare
to make showings, FDA is providing responsible parties with an
additional 6 months, i.e., until July 1, 2001, to prepare, e.g., by
compiling records, to make a showing to FDA to demonstrate that a
processed food is within the scope of FDA's exercise of its enforcement
discretion set forth in this guidance.
Several comments addressed the approach FDA stated it intended to
follow if it were to find residues of methyl parathion in multiple
ingredient foods for which all ingredients are subject to the current
Environmental Protection Agency (EPA) methyl parathion tolerance
revocation action, e.g., an apple-pear juice. The comments stated that
the approach taken in the draft is not consistent with current FDA
policy in a related situation regarding pesticide residues in multiple
ingredient foods. Under existing FDA policy, if FDA finds a pesticide
residue in a multiple ingredient food, e.g., mixed vegetables, in which
there is a tolerance for the pesticide in some, but not all of the
ingredients, FDA does not ask the responsible firm to demonstrate that
the residue is not present in any of the ingredients for which there is
no tolerance.
In response to these comments, FDA is revising its planned approach
in this final guidance. If FDA finds a residue of methyl parathion in
such a multiple ingredient food, e.g., apple-pear juice, to be within
the scope of FDA's exercise of enforcement discretion, the responsible
party should demonstrate that at least one of the food's ingredients
could bear the methyl parathion residue as a result of a lawful
application or use of this pesticide chemical. However, if the
responsible party makes that showing, FDA does not intend to ask the
responsible party to provide additional documentation showing that
other ingredients in the food were not the source of the residue of
methyl parathion.
FDA has also added additional examples in the final guidance on the
approach it intends to follow if it finds methyl parathion residues in
multiple ingredient foods in which some ingredients are subject to the
current EPA methyl parathion tolerance revocation action and other
ingredients are subject to tolerances that remain in effect or are not
subject to a tolerance at all.
A comment asked if FDA considered whether methyl parathion could
persist in the soil and transfer into crops grown after legal
application of this pesticide was terminated by EPA. FDA has worked
closely with EPA in developing this guidance, and EPA has given no
indication to FDA that residues of methyl parathion persist in the
environment such that a food could contain residues of methyl parathion
resulting from the application of this pesticide to a previously grown
crop. Thus, FDA intends to assume that any residue of methyl parathion
found on a food results from application of the pesticide to the crop
used to produce the analyzed food.
In response to a request in a comment, FDA, in the final guidance,
has provided an example of a situation whereby FDA could come to
possess information indicating that there is a reasonable possibility
that a residue, that is within the former tolerance, resulted from
application of the pesticide to the crop after December 31, 1999, which
would constitute an unlawful use of methyl parathion.
Finally, in response to comments expressing concern that food
retailers would reject food rather than accept the potential burden of
making a showing as the ``responsible party,'' the agency advises that
under its compliance program for pesticide residues in domestic foods
(FDA monitors pesticide residues in both raw agricultural commodities
and processed foods in interstate commerce under this program), samples
for routine monitoring purposes are generally not collected at the
retail level. The program directs that growers or packing sheds are the
preferred sites for sampling fruits and vegetables. Thus, FDA does not
expect that in the normal course of business, retailers will be in the
role of the ``responsible party'' under this policy.
This final guidance is being issued as a level 1 guidance,
consistent with FDA's policy for good guidance practices as set out in
the Federal Register of September 19, 2000 (65 FR 56468). This guidance
represents the agency's current thinking on the channels of trade
provision and how this provision relates to FDA-regulated products with
methyl parathion residues. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
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II. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the final guidance. Two copies of
any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The final guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov.
Dated: December 19, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-368 Filed 1-4-01; 8:45 am]
BILLING CODE 4160-01-F
Guidance for Industry: Channels of Trade Policy for Commodities with Methyl Parathion Residues (Final Guidance)