[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6075-6076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1516]



[[Page 6075]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0038]


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 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 reporting and 
recordkeeping requirements for food irradiation processors.

DATES:  Submit written or electronic comments on the collection of 
information by April 7, 2006.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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 these topics: (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) (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 ensure 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 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 per
         21 CFR  Section              No. of recordkeepers          recordkeeping           Total annual records      Hours per record      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

[[Page 6076]]

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: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1516 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S