[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Notices]
[Pages 62487-62488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25390]


-----------------------------------------------------------------------

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, 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