[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1247-1248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-368]



  Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / 
Notices  

[[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: [email protected].

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that draft guidance after considering the five comments that were 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