[Federal Register Volume 60, Number 45 (Wednesday, March 8, 1995)]
[Rules and Regulations]
[Pages 12669-12670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5672]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket Nos. 89F-0011 and 93F-0384]
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 provide for the safe use of sources of
radiation to irradiate frozen, packaged meats for use in the National
Aeronautics and Space Administration (NASA) space flight programs. FDA
is also amending the food additive regulations to permit the use of
packaging materials that are not otherwise listed in the regulations
regarding food irradiation in the irradiation of frozen, packaged meats
for use in the NASA space flight programs. This action is in response
to two petitions filed by NASA.
DATES: Effective March 8, 1995; written objections and requests for a
hearing by April 7, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Patricia A. Hansen, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3098.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notice published in the Federal Register of February 6, 1989
(54 FR 5679), FDA announced that a food additive petition (FAP 9M4125)
had been filed by NASA, Washington, DC 20546, proposing that the food
additive regulations be amended to provide for the safe use of sources
of radiation to process beefsteaks for use in space flight programs.
In a tentative final rule published in the Federal Register of
December 8, 1993 (58 FR 64526), FDA announced its tentative decision to
amend the food additive regulations to provide for the safe use of
sources of radiation to irradiate frozen, packaged beefsteak for use in
NASA's space flight programs. FDA also announced its tentative final
decision to amend the food additive regulations to permit the use of
packaging materials that are not listed in the regulations regarding
food irradiation in the irradiation of frozen, packaged beefsteak for
use in the NASA space flight programs. The agency published a tentative
final rule before proceeding to final action because it was including
provisions regarding the packaging materials to be used with the
beefsteaks that it had not announced in the notice of filing for the
petition (FAP 9M4125). Interested persons were given the opportunity to
comment on FDA's tentative decision. FDA did not receive any comments
in response to this tentative final rule.
In the meantime, in a notice published in the Federal Register of
November 19, 1993 (58 FR 61093), FDA announced that a food additive
petition (FAP 3M4394) had been filed by NASA, Lyndon B. Johnson Space
Center, Houston, TX 77058, proposing that the food additive regulations
be amended to provide for the safe use of sources of radiation to
process certain prepackaged meats for use in NASA space flight programs
and to permit the use of packaging materials that are not listed in the
regulations regarding food irradiation in the irradiation of the meats
for use in NASA space flight programs. Interested persons were given
the opportunity to comment on the environmental assessment submitted in
the petition. No comments were received.
The amendment to the food additive regulations proposed in FAP
9M4125 is encompassed by that proposed in FAP 3M4394. This rule is the
agency's final decision with respect to both FAP 3M4394 and FAP 9M4125.
II. Evaluation of Safety
In assessing the safety of food additives, including the use of
irradiation in the processing of food, the agency usually considers the
effects of lifetime daily exposure to the additive. The requested use,
however, is limited to NASA's space flight programs. The amount of
irradiated meat that could be consumed by individuals in the programs
would constitute an extremely small fraction of their diets when
considered over a lifetime. Because of this factor, questions regarding
acute hazards, including those resulting from pathogenic organisms that
could be present in the food, are more significant in evaluating this
petitioned use of a source of radiation than they would ordinarily be
in deciding whether to list a food additive. The petitions have
requested that FDA authorize the use of irradiation processing only
under conditions that ensure the microbial sterility of the product and
the integrity of the product packaging. NASA has stated that it will
ensure these qualities of sterility and packaging integrity by
requiring adherence to an irradiation processing protocol (scheduled
process) that it submitted with both petitions (Ref. 1). NASA's
protocol specifies a minimum dose of 44 kiloGrays (kGy) in order to
ensure sterility of the treated meat (Ref. 1).
Having evaluated the data in the petitions and other relevant
material in its files, the agency finds that radiation-sterilized meats
will be at least as nutritious as those sterilized by conventional
means. FDA also finds that the total amount of radiolytic products that
are produced in the meats during irradiation processing, and that will
be consumed by individuals in the space flight programs, will be too
small to be of any toxicological significance. Likewise, FDA finds that
the total amount of radiolytic products that could be formed in the
packaging materials during irradiation processing, and then migrate to
the food and subsequently be consumed by individuals in the space
flight programs, is too small to be of any toxicological significance
(Refs. 2 and 3).
Section 179.25(c) (21 CFR 179.25(c)) restricts packaging materials
used in the irradiation of prepackaged foods to those materials listed
in Sec. 179.45 (21 CFR 179.45), namely, those that have been
demonstrated to be safe for use during irradiation of prepackaged
foods, assuming that those foods would be consumed daily over a
lifetime. The agency finds that this restriction is unnecessary for
packaging that is to be used only in space flight programs. The
[[Page 12670]] final regulation set forth below, therefore, exempts
this packaging from the requirement in Sec. 179.25(c) that packaging
materials be restricted to those listed in Sec. 179.45, provided that
FDA has listed the packaging as safe for holding food in the applicable
regulations ((parts 174 through 186) (21 CFR parts 174 through 186)).
III. Conclusions
The agency finds that meats irradiated at a minimum dose of 44 kGy
and handled in accordance with the provisions of Sec. 179.25(d) will
meet current standards for commercial sterility and nutritional
adequacy. The protocol submitted by NASA (Ref. 1) in its petitions is a
scheduled process that satisfies the requirements of Sec. 179.25(d)
because, among other things, it sets forth procedures that will ensure
that the minimum dose will be delivered. The agency concludes,
therefore, that the proposed use of sources of radiation is safe, and
that Sec. 179.26 of the regulations should be amended as set forth
below.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petitions
and the documents that FDA considered and relied upon in reaching its
decision to approve the petitions 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 21 CFR
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.
IV. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
V. Objections
Any person who will be adversely affected by this regulation may at
any time on or before April 7, 1995, file with the Dockets Management
Branch (address above) written objections thereto. 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 shall be
submitted and shall 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.
VI. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. U.S. Army Natick RD & E Center, ``Space Food Prototype,
Production Guide No. 60-C,'' April 13, 1993.
2. Memorandum from M. DiNovi, Chemistry Review Branch, CFSAN,
FDA, to P. Hansen, Biotechnology Policy Branch, CFSAN, FDA, dated
April 29, 1994.
3. Memorandum from H. Irausquin, Division of Health Effects
Evaluation, CFSAN, FDA, to P. Hansen, Biotechnology Policy Branch,
CFSAN, FDA, dated November 9, 1994.
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 and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 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: Secs. 201, 402, 403, 409, 703, 704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 373,
374).
2. Section 179.26 is amended in the table in paragraph (b) by
adding a new entry ``7.'' under the headings ``Use'' and
``Limitations'' to read as follows:
Sec. 179.26 Ionizing radiation for the treatment of food.
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(b) * * *
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Use Limitations
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7. For the sterilization of frozen, Minimum dose 44 kGy (4.4 Mrad).
packaged meats used solely in the Packaging materials used need not
National Aeronautics and Space comply with Sec. 179.25(c)
Administration space flight provided that their use is
programs. otherwise permitted by applicable
regulations in parts 174 through
186 of this chapter.
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Dated: February 26, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 95-5672 Filed 3-7-95; 8:45 am]
BILLING CODE 4160-01-F
