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FDA to expand use of radiation for prepackaged food
Saw this in passing.
-- John
John Jacobus, MS, CHP
Health Physicist
3050 Traymore Lane
Bowie, MD 20715-2024
E-mail: jenday1@email.msn.com (H)
[Federal Register: February 16, 2001 (Volume 66, Number 33)]
[Rules and Regulations]
[Page 10574-10575]
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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.
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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
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
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