[Federal Register Volume 66, Number 33 (Friday, February 16, 2001)]
[Rules and Regulations]
[Pages 10574-10575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3885]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 00F-0789]


Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to expand the conditions of safe use of X-
radiation and electron beam energy sources for the treatment of 
prepackaged foods by irradiation. This action is in response to a 
petition filed by the National Center for Food Safety and Technology, 
Illinois Institute of Technology.

DATES: This rule is effective February 16, 2001. Submit written 
objections and requests for a hearing by March 19, 2001.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 2, 2000 (65 FR 11320), FDA announced that a food 
additive petition (FAP 0M4711) had been filed by the National Center 
for Food Safety and Technology, Illinois Institute of Technology, 6502 
South Archer Rd., Summit-Argo, IL 60501-1933. The petition proposed to 
amend the food additive regulations in Sec. 179.45 Packaging materials 
for use during the irradiation of prepackaged foods (21 CFR 179.45) to 
expand the conditions of safe use of X-radiation and electron beam 
energy sources for the treatment of prepackaged foods by irradiation.
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additives as sources of radiation for irradiating 
of prepackaged foods is safe, (2) the additives will achieve their 
intended technical effect, and therefore, (3) the regulations in 
Sec. 179.45 should be amended as set forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.
    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 0M4711. No new 
information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that an environmental impact statement is not 
required.
    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by March 19, 2001. Each objection shall be 
separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event

[[Page 10575]]

that a hearing is held. Failure to include such a description and 
analysis for any particular objection shall constitute a waiver of the 
right to a hearing on the objection. Three copies of all documents are 
to be submitted and are to be identified with the docket number found 
in brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

    1. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.


Sec. 179.45  [Amended]

    2. Section 179.45 Packaging materials for use during the 
irradiation of prepackaged foods is amended in the introductory text of 
paragraph (b) by adding the phrase ``, electron beam, or X-'' after the 
word ``gamma'' and in the introductory text of paragraph (d) by adding 
the phrase ``, electron beam,'' after the word ``gamma''.

    Dated: January 31, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-3885 Filed 2-15-01; 8:45 am]
BILLING CODE 4160-01-F