[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]
 
-----------------------------------------------------------------------
 
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.
 
-----------------------------------------------------------------------
 
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, §&thnsp;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, §&thnsp;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 §&thnsp;10.30 (21 CFR 10.30), except that
§&thnsp;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 (§&thnsp;10.115 (21 CFR
10.115)). The agency is soliciting public comment, but is implementing
this guidance document immediately in accordance with
§&thnsp;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 §&thnsp;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/~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