[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