
[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Pages 29352-29353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0473]


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 information collection 
provisions of FDA's requirements for food irradiation processors.

DATES: Submit either electronic or written comments on the collection 
of information by July 16, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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 FD&C Act) (21 U.S.C. 321(s) and 348), food 
irradiation is subject to regulation under the food additive premarket 
approval provisions of the FD&C 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 (or minimum and maximum) energy of radiation 
emitted by X-ray tube sources. Section 179.21(b)(2) requires that the 
label or accompanying labeling bear adequate directions for 
installation and use and a statement supplied by FDA that indicates 
maximum dose of radiation allowed. Section 179.26(c) requires that the 
label or accompanying labeling bear a logo and a radiation disclosure 
statement. 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.
    Description of respondents: Respondents are businesses engaged in 
the irradiation of food.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 29353]]



                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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179.25(e), Large processors.....               3             300             900               1             900
179.25(e), Small processors.....               4              30             120               1             120
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    Total.......................  ..............  ..............  ..............  ..............           1,020
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimate of burden for the recordkeeping provisions 
of Sec.  179.25(e) on the Agency's experience regulating the safe use 
of radiation as a direct food additive. The number of firms who process 
food using irradiation is extremely limited. FDA estimates that there 
are three 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 three facilities devoting 100 
percent of their business to food irradiation (3 x 300 hours = 900 
hours for recordkeeping annually), and four facilities devoting 10 
percent of their business to food irradiation (4 x 30 hours = 120 hours 
for recordkeeping annually).
    No burden has been estimated for the labeling requirements in 
Sec. Sec.  179.21(b)(1), 179.21(b)(2), 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: May 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11933 Filed 5-16-12; 8:45 am]
BILLING CODE 4160-01-P


