[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Pages 27332-27333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0073]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 or we) 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 July 
12, 2018.

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 [email protected]. 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: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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

OMB Control Number 0910-0186--Extension

    This information collection supports FDA regulations. Specifically, 
under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic 
Act (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 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. 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.

[[Page 27333]]

    In the Federal Register of January 26, 2018, (83 FR 3734), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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179.25(e); records for large                   4             300           1,200               1           1,200
 processors.....................
179.25(e); records for small                   4              30             120               1             120
 processors.....................
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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 of
  information.

    Upon review of the information collection we have retained the 
currently approved burden estimate. FDA's estimate of the recordkeeping 
burden under Sec.  179.25(e) is based on 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 = 1,200 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 disclosures are 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 OMB under the Paperwork Reduction Act 
of 1995.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12614 Filed 6-11-18; 8:45 am]
 BILLING CODE 4164-01-P


