[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Notices]
[Pages 57443-57444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0403]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the recordkeeping and labeling requirements for 
food irradiation processors.

DATES: Submit written comments on the collection of information by 
January 6, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Kim A. Sanders, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1473.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval 
from the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information 
listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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

    Under sections 201(s) and 409 of the Federal Food, Drug, and 
Cosmetic Act (the act), food irradiation is subject to regulation as a 
food additive (21 U.S.C. 321(s) and 348). 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 assure 
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

[[Page 57444]]

no food shall be exposed to radiation source 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:

                                 Table 1.--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.                  

    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: October 30, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-28581 Filed 11-5-96; 8:45 am]
BILLING CODE 4160-01-F