89 FR 111 pgs. 48651-48652 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
Type: NOTICEVolume: 89Number: 111Pages: 48651 - 48652
Pages: 48651, 48652Docket number: [Docket No. FDA-2018-N-0073]
FR document: [FR Doc. 2024-12536 Filed 6-6-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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, 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
[top] 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
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:
| 21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 179.25(e), large processors | 4 | 300 | 1,200 | 1 | 1,200 |
| 179.25(e), small processors | 4 | 30 | 120 | 1 | 120 |
| Total | 1,320 | ||||
| 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 §?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 §§?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]
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