[Federal Register Volume 67, Number 249 (Friday, December 27, 2002)]
[Notices]
[Pages 79126-79127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0514]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including an 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 reporting and recordkeeping requirements for 
food irradiation processors.

DATES: Submit written or electronic comments on the collection of 
information by February 25, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane., rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under 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 set forth in this document.
    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 section 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 under the food additive premarket approval 
provisions of the act. 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 a 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

[[Page 79127]]

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
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                                            Annual Frequency of    Total Annual
                 21 CFR Section                    No. of Recordkeepers        Recordkeeping          Records     Hours per Recordkeeper    Total Hours
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179.25(e)                                                   6                     120                 720                   1                 720
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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 are two irradiation plants whose 
business is devoted primarily (i.e., approximately 100 percent) to 
irradiation of food and other agricultural products. Four other firms 
also irradiate small quantities of food. 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: Two facilities devoting 100 percent of their business (or 600 hours 
for recordkeeping annually) to food irradiation; four facilities 
devoting 10 percent of their business or 120 hours (4 x 30 hours) for 
recordkeeping annually to food irradiation.
    No burden has been estimated for the labeling requirements in 
Sec. Sec.  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.

    Dated: December 19, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32662 Filed 12-26-02; 8:45 am]
BILLING CODE 4160-01-S