[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17055-17056]
From the Federal Register Online via the Government Publishing 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, [email protected].
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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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