Document ID: FDA-2012-N-0473-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Irradiation in the Production, Processing, and Handling of Food
Posted Date: 2015-03-31T04:00Z

[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17055-17056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07263]

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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 our proposed collection of certain 
information. Under the Paperwork Reduction Act of 1995 (the PRA), 
Federal Agencies must publish notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information, and allow 60 days 
for public comment. This notice invites comments on the information 
collection provisions of our requirements for food irradiation 
processors.

DATES: Submit either electronic or written comments on the collection 
of information by June 1, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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 the 
emitted radiation. Section 179.21(b)(2) requires that the label or 
accompanying labeling bear adequate directions for installation and use 
and a statement supplied by us 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 our inspectors to assess compliance with the regulation that 
establishes limits within which radiation may be safely used to treat 
food. We 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.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                  record-keepers   recordkeeper       records      recordkeeping
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179.25(e), large processors.....               4             300           1,200               1           1,200
179.25(e), small processors.....               4              30             120               1             120
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[[Page 17056]]

 
    Total.......................  ..............  ..............  ..............  ..............           1,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    We base our estimate of burden for the recordkeeping provisions of 
Sec.  179.25(e) on our experience regulating the safe use of radiation 
as a direct food additive. The number of firms who process food using 
irradiation is extremely limited. We estimate that there are four 
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. We estimate 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 four facilities devoting 100 percent of 
their business to food irradiation (4 x 300 hours = 1200 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 subject to review by the 
Office of Management and Budget under the Paperwork Reduction Act.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07263 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P