[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48651-48652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12536]


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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) 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: Submit written comments (including recommendations) on the 
collection of information by July 8, 2024.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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. Under 
sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(s) and 348), food irradiation is subject to regulation by 
FDA under the food additive premarket approval provisions. The 
regulations providing for uses of

[[Page 48652]]

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 to the information 
collection are businesses engaged in the irradiation of food.
    In the Federal Register of January 23, 2024 (89 FR 4311), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment related to the PRA was received 
which suggested that FDA could enhance and improve the information 
received in this collection of information by clarifying reporting 
requirements, detailing consistent guidelines, conducting training and 
educational programs to increase understanding, and integrating 
technology into the process. The comment also indicated that regular 
audits and checks should be instituted, and the implementation of these 
suggestions will increase the quality of the information being 
collected.
    FDA strives to protect the public health and safety in irradiated 
food and packaging. FDA's website at https://www.fda.gov/food/food-ingredients-packaging/irradiation-food-packaging provides a discussion 
of FDA's regulation of irradiated food as well as information about the 
history, science, and regulations of irradiated food and packaging. In 
addition, FDA offers educational webinars, such as the joint CFSAN/
JIFSAN webinar on Food Packaging and Irradiation. This webinar can be 
found on YouTube at https://www.youtube.com/watch?v=X3rYqwHx_KU. This 
webinar provides some clarification on food processing and handling of 
irradiated food. FDA also conducts inspections on an as-needed basis to 
check on the accuracy of the records being maintained by food 
processors and to ensure the safety of irradiated food and packaging.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting 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), 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: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12536 Filed 6-6-24; 8:45 am]
BILLING CODE 4164-01-P