[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22688-22689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08949]


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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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[[Page 22689]]

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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by June 1, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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 Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@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

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 used to treat 
food, Sec.  179.21(b)(1) (21 CFR 179.21(b)(1)) requires that the label 
of the radiation 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) (21 CFR 179.26(c)) 
requires that the label or accompanying labeling of foods treated by a 
source of radiation bear a logo and a radiation disclosure statement.
    Section 179.25(e) (21 CFR 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 to the information 
collection are businesses engaged in the irradiation of food.
    In the Federal Register of October 16, 2020 (85 FR 65825), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although three comments were received, none 
pertained to the information collection topics solicited in the notice 
or suggested a change to our burden estimate.
    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
         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.....               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 of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. Our estimate of the recordkeeping burden under Sec.  
179.25(e) is based 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, and four facilities devoting 10 
percent of their business to food irradiation.
    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 OMB under the PRA.

    Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08949 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P


