[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Notices]
[Page 28544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9811]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0263] (formerly Docket No. 03D-0263)


Guidance for Industry on 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With Residues of Pesticide Chemicals, for Which Tolerances Have Been 
Revoked, Suspended, or Modified by the Environmental Protection Agency 
Pursuant to Dietary Risk Considerations; 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 guidance for industry entitled ``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Tolerances Have Been Revoked, Suspended, or Modified by the 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 Pursuant to Dietary Risk 
Considerations.'' This guidance presents FDA's general policy for 
implementing the channels of trade provision in the Federal Food, Drug, 
and Cosmetic Act (the act), as amended by the Food Quality Protection 
Act of 1996 (the FQPA), for food containing residues of pesticide 
chemicals, for which tolerances have been revoked, suspended, or 
modified pursuant to dietary risk considerations.

DATES: You may submit written or electronic comments on agency 
guidances at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
Michael E. Kashtock, Office of Plant and Dairy Foods, Center for Food 
Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Include a self-
addressed adhesive label to assist that office in processing your 
request. Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 23, 2003 (68 FR 43535), FDA 
announced the availability of a draft guidance document entitled 
``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.'' This guidance presents FDA's general policy for implementing 
the channels of trade provision in the act, as amended by the FQPA. 
Interested persons were given until September 22, 2003, to comment on 
the draft guidance.
    FDA received five written comments on the draft guidance document. 
The agency reviewed and evaluated these comments and has modified the 
guidance where appropriate. In particular, FDA has modified the 
guidance document, including its title, to make it clear that it 
applies solely to food commodities that contain residues of pesticide 
chemicals for which the applicable tolerance was revoked, suspended, or 
modified by the Environmental Protection Agency (EPA) pursuant to 
dietary risk considerations as addressed under section 408(l)(2) of the 
FQPA. A comment pointed out that this condition was implied in the 
draft guidance document, but that it should be explicit in the final 
guidance.
    FDA is issuing this guidance as a level 1 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The guidance 
represents the agency's current thinking on its planned enforcement 
approach to the channels of trade provision of the act and how that 
provision relates to FDA-regulated products with residues of pesticide 
chemicals for which tolerances have been revoked, suspended, or 
modified by EPA pursuant to dietary risk considerations. 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 it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
Control No. 0910-0562. The approval expires on May 31, 2008. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Interested persons also may access the guidance document at http://www.cfsan.fda.gov/guidance.html.

    Dated: March 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9811 Filed 5-17-05; 8:45 am]
BILLING CODE 4160-01-S