Notice2024-12536
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 7, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 111 (Friday, June 7, 2024)</title>
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[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48651-48652]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#d9898b988aadb8bfbf99bfbdb8f7b1b1aaf7beb6af"><span class="__cf_email__" data-cfemail="94c4c6d5c7e0f5f2f2d4f2f0f5bafcfce7baf3fbe2">[email protected]</span></a>.
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 <a href="https://www.fda.gov/food/food-ingredients-packaging/irradiation-food-packaging">https://www.fda.gov/food/food-ingredients-packaging/irradiation-food-packaging</a> 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 <a href="https://www.youtube.com/watch?v=X3rYqwHx_KU">https://www.youtube.com/watch?v=X3rYqwHx_KU</a>. 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
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