[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Pages 15343-15344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-5325]


Agency Information Collection Activities; Submission for OMB 
Review; Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
April 21, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Irradiation in the Production, Processing, and Handling of Food--
21CFR Part 179 (OMB Control Number 0910-0186--Extension)

    Under sections 201(s) and 409 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is 
subject to regulation as a food additive. The regulations providing for 
uses of irradiation in the production, processing, and handling of food 
are found in part 179 (21 CFR part 179).
    To assure safe use of radiation source, Sec. 179.21(b)(1) requires 
that the label of sources bear appropriate and accurate information 
identifying the source of radiation and the maximum energy of radiation 
emitted by X-ray tube sources. Section 179.21(b)(2)(i) requires that 
the label or accompanying labeling bear adequate directions for 
installation and use.
    Section 179.25(e) requires that food processors who treat food with 
radiation make and retain, for 1 year past the expected shelf life of 
the products up to a maximum of 3 years, specified records relating to 
the irradiation process (e.g., the food treated, lot identification, 
scheduled process, etc.).
    The records required by Sec. 179.25(e) are used by FDA inspectors 
to assess compliance with the regulation that establishes limits within 
which radiation may be safely used to treat food. The agency cannot 
ensure safe use without a method to assess compliance with the dose 
limits, and there are no practicable methods for analyzing most foods 
to determine whether they have been treated with ionizing radiation and 
are within the limitations set forth in part 179. Records inspection is 
the only way to determine whether firms are complying with the 
regulations for treatment of foods with ionizing radiation.
    In the Federal Register of December 29, 1999 (64 FR 73054), the 
agency requested comments on the proposed collections of information 
(hereinafter referred to as the 60-day notice). No significant comments 
were received.
    FDA estimates the burden of this collection of information as 
follows:

                                Table1.--Estimated Annual Recordkeeping Burden\1\
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                         No. of         Annual Frequency      Total Annual        Hours per
  21 CFR Section      Recordkeepers     per Recordkeeping       Records         Recordkeeper       Total Hours
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      179.25(e)            3                 120                 360                 1              360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of firms who process food using irradiation is extremely 
limited. FDA estimates that there is a single irradiation plant whose 
business is devoted primarily (i.e., approximately 100 percent) to 
irradiation of food and other agricultural products. Two other firms 
also irradiate small quantities of food (mainly spices). FDA estimates 
that this irradiation accounts for no more than 10 percent of the 
business for each of these firms. Although recent FDA rulemaking has 
authorized the irradiation of red meat, the United States Department of 
Agriculture/Food Safety and Inspection Service (USDA/FSIS) has yet to 
issue a rule regarding meat irradiation. Actual implementation of meat 
irradiation cannot take place until USDA/FSIS final regulations are in 
place, which may not take place until later this fiscal year. At this 
time, FDA has no basis for estimating the extent of changes in the food 
irradiation business

[[Page 15344]]

as a result of future USDA/FSIS actions. Therefore, the average 
estimated burden is based on the following: (1) A facility devoting 100 
percent of its business (or 300 hours for recordkeeping annually) to 
food irradiation; and (2) facilities devoting 10 percent of their 
business or 60 hours (2 x 30 hours) for recordkeeping annually, to food 
irradiation or (300 + 60)/3 = 120 x 3 firms x 1 hour = 360 hours 
annually.
    As stated in the 60-day notice, no burden was estimated for the 
labeling requirements in Secs. 179.21(b)(2)(i) and (b)(2)(ii) and 
179.26(c) because the information to be disclosed is information that 
has been supplied by FDA. Under 5 CFR 1320.3(c)(2), the public 
disclosure of information originally supplied by the Federal Government 
to the recipient for the purpose of disclosure to the public is not a 
collection of information. Therefore in this notice, table 1 from the 
60-day notice (64 FR 73054 at 73055) estimated annual reporting burden 
is not included.

    Dated: March 16, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7008 Filed 3-21-00; 8:45 am]
BILLING CODE 4160-01-F