[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43842-43843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18234]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0473]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
27, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0186.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 43843]]
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.
In the Federal Register of May 17, 2012 (77 FR 29352), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received outside the scope
of the four collection of information topics solicited by the notice.
Description of respondents: Respondents are businesses engaged in
the irradiation of food.
FDA estimates the burden of this collection of information as
follows:
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 3 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 3 facilities devoting 100 percent
of their business to food irradiation (3 x 300 hours = 900 hours for
recordkeeping annually), and 4 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: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18234 Filed 7-25-12; 8:45 am]
BILLING CODE 4160-01-P