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Industry on Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations; Availability, 28544 [05-9811]
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Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Notices
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. OMB has now approved the
information collection and has assigned
OMB control number 0910–0359. The
approval expires on April 30, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: May 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9810 Filed 5–17–05; 8:45 am]
BILLING CODE 4160–01–S
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Which Tolerances Have Been Revoked,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.
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Been Revoked, Suspended, or Modified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tolerances have been revoked,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
VerDate jul<14>2003
14:03 May 17, 2005
Jkt 205001
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 https://
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:
mkashtoc@cfsan.fda.gov.
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; 5 A Day Customized Survey
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
E:\FR\FM\18MYN1.SGM
18MYN1
]]>Agencies
[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Notices]
[Page 28544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9811]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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:
mkashtoc@cfsan.fda.gov.
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 https://
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
