[Federal Register: October 7, 2002 (Volume 67, Number 194)]
[Notices]
[Page 62487-62488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc02-100]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0385]
Guidance on the Petition Process to Request Approval of Labeling
for Foods That Have Been Treated By Irradiation; 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 document entitled ``Guidance; Implementation
of Section 10809 of the Farm Security and Rural Investment Act of 2002,
Pub. L. No. 107-171, Sec. 10809 (2002) Regarding the Petition Process
to Request Approval of Labeling for Foods That Have Been Treated By
Irradiation,'' which explains the recommended process for petitioning
the agency for approval of labeling, which is not false or misleading
in any material respect, of a food that has been treated by
irradiation.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food
Safety and Applied Nutrition (HFS-822), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance document
implementing the part of section 10809 of the Farm Security and Rural
Investment Act of 2002 (Public Law 107-171, Sec. 10809 (2002)), that
states that ``[p]ending promulgation of the final rule * * *, any
person may petition the Secretary [FDA] for approval of labeling, which
is not false or misleading in any material respect, of a food which has
been treated by irradiation using radioactive isotope, electronic beam,
or x-ray.'' Section 10809 of the Farm Security and Rural Investment Act
of 2002 also requires that, pending promulgation of the final rule,
``[t]he Secretary [FDA] shall approve or deny such a petition within
180 days of receipt of the petition, or the petition shall be deemed
denied, except to the extent additional agency review is mutually
agreed upon by the Secretary [FDA] and the petitioner.''
FDA is issuing this guidance to interested parties who wish to
petition the agency for approval of the labeling of a food treated by
irradiation. As explained in the guidance, FDA recommends that
interested parties who wish to petition the agency use the procedures
set forth in Sec. 10.30 (21 CFR 10.30), except that Sec.
10.30(e)(2)(iii), regarding 180-day tentative responses,
[[Page 62488]]
does not apply, because section 10809 of the Farm Security and Rural
Investment Act of 2002 provides that the petition is deemed denied if
the Secretary (FDA) fails to act on the petition within 180 days of its
receipt, unless the parties mutually agree upon an extension.
This guidance is a level 1 guidance issued consistent with FDA's
good guidance practices regulation (Sec. 10.115 (21 CFR 10.115)). The
agency is soliciting public comment, but is implementing this guidance
document immediately in accordance with Sec. 10.115(g)(2) because the
agency has determined that prior public participation is not feasible
or appropriate. The Farm Security and Rural Investment Act of 2002
(Public Law 107-171) was enacted on May 13, 2002, and section 10809 is
now in effect and must be implemented immediately. Thus, there is a
pressing need for guidance to help effect such implementation.
Accordingly, FDA is making this guidance effective immediately. This
guidance represents the agency's current thinking on this subject. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternate approach may be used if
such approach 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 citizen petitions under Sec. 10.30 is
approved under OMB control number 0910-0183.
III. Comments
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments on this guidance at any time.
Groups or organizations must submit two copies of any written comments.
Individuals may submit one copy of their comments. Identify your
written comments by placing the docket number at the top of your
comment(s). If you base your comments on scientific evidence or data,
please submit copies of the specific information along with your
comments. Any comments submitted will be filed under the docket number
identified in brackets in the heading of this document. The guidance
and received comments may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http:/www.cfsan.fda.gov/[tilde]dms/guidance.html.
Dated: September 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25390 Filed 10-4-02; 8:45 am]
BILLING CODE 4160-01-S