[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13648-13649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97N-0092]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Reinstatement

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

[[Page 13649]]

clearance under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
April 21, 1997.

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: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (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 (21 
CFR Part 179)--(OMB Control Number 0910-0186--Reinstatement)

    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).
    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.).
    Section 179.26(c) requires that food processors label retail 
packages of irradiated foods with an FDA prescribed logo and statement, 
``Treated with radiation'' or ``Treated by irradiation.'' To ensure 
safe use of radiation sources, Sec. 179.21(b)(1) requires that the 
label of sources bear appropriate and accurate information identifying 
the source of radiation (Sec. 179.21(b)(1)(i)) and the maximum energy 
of radiation emitted by x-ray tube sources (Sec. 179.21(b)(1)(ii)). 
Section 179.21(b)(2) requires that the label or accompanying labeling 
bear adequate directions for installation and use 
(Sec. 179.21(b)(2)(i)), a statement that no food shall be exposed to 
radiation sources so as to receive an absorbed dose of x-radiation in 
excess of 10 grays (Sec. 179.21(b)(2)(ii)) or an absorbed dose of 
certain radioisotopes\1\ in excess of 2 milligrays 
(Sec. 179.21(b)(2)(iii)).
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    \1\ The isotopes identified by the regulation are americium-241, 
cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, and 
strontium-90.
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    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.
    FDA estimates the burden of this collection of information as 
follows:

                                      Estimated Annual Recordkeeping Burden                                     
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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179.25(e)                               3             120             360               1             360       
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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 
facilities 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. Therefore, the average estimated 
burden is based on: (1) Facility devoting 100 percent of its business 
(or 300 hours for recordkeeping annually) to food irradiation; (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.
    No burden has been estimated for the labeling requirements in 
Sec. 179.21(b)(1) and (b)(2)(i) because it is a usual and customary 
business practice for manufacturers of food processing equipment to 
label (identify) their products for use by their customers. Under 5 CFR 
1320.3(b)(2), the time, effort, and financial resources necessary to 
comply with a collection of information are excluded from the burden 
estimate if the reporting, recordkeeping, or disclosure activities 
needed to comply are usual and customary because they would occur in 
the normal course of activities. In addition, no burden has been 
estimated for Secs. 179.21(b)(2)(ii) and (b)(2)(iii) and 179.26(c) 
because FDA provides the exact wording and logo that is to be used on 
the label. 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.

    Dated: March 13, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7131 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F