2023-04174. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) 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 March 31, 2023.

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 0910-0466. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, [e-mail].

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.

Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice—21 CFR Part 120

OMB Control Number 0910-0466—Extension

This information collection supports regulations in part 120 (21 CFR part 120) which mandate the application of HACCP procedures to the processing of fruit and vegetable juices. HACCP is a preventative system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA's statutory authority to regulate food safety under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a food is adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. The Agency also has authority under section 361 of the Public Health Service Act (42 U.S.C. 264) to issue and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from one State, territory, or possession to another, or from outside the United States into this country. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act.

Under HACCP, processors of fruit and vegetable juices establish and follow a preplanned sequence of operations and observations (the HACCP plan) designed to avoid or eliminate one or more specific food hazards, and thereby ensure that their products are safe, wholesome, and not adulterated, in compliance with section 402 of the FD&C Act. Information development and recordkeeping are essential parts of any HACCP system. The information collection requirements are narrowly tailored to focus on the development of appropriate controls and document those aspects of processing that are critical to food safety.

In an effort to reduce burden and assist respondents, our website ( https://www.fda.gov/​food/​hazard-analysis-critical-control-point-haccp/​juice-haccp) offers guidance for industry, training and education, and background information to assist the food industry in developing and implementing a juice HACCP. Included in this information are guidance documents entitled “Juice HACCP and the FDA Food Safety and Modernization Act” (December 2021) (available at: https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-juice-haccp-and-fda-food-safety-modernization-act) and “Juice HACCP Hazards and Controls Guidance—First Edition” (March 2004) (available at: https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first). All Agency guidance documents are issued in accordance with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time

In the Federal Register of October 7, 2022 (87 FR 61087), 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

21 CFR section; activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
120.6(c) and 120.12(a)(1) and (b); require written monitoring and correction records for Sanitation Standard Operating Procedures	1,875	365	684,375	0.1 (6 minutes)	68,438
120.7, 120.10(a), and 120.12(a)(2), (b)-(c); require written hazard analysis of food hazards	2,300	1.1	2,530	20	50,600
120.8(b)(7) and 120.12(a)(4)(i) and (b); require a recordkeeping system that documents monitoring of the critical control points and other measurements as prescribed in the HACCP plan	1,450	14,600	21,170,000	0.01 (1 minute)	211,700
120.10(c) and 120.12(a)(4)(ii) and (b); require that all corrective actions taken in response to a deviation from a critical limit be documented	1,840	12	22,080	0.1 (6 minutes)	2,208
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) and (b); require records showing that process monitoring instruments are properly calibrated and that end-product or in-process testing is performed in accordance with written procedures	1,840	52	95,680	0.1 (6 minutes)	9,568
120.11(b)-(c) and 120.12(a)(5) and (b); require that every processor record the validation that the HACCP plan is adequate to control food hazards that are likely to occur	1,840	1	1,840	4	7,360
120.11(c) and 120.12(a)(5) and (b); require documentation of revalidation of the hazard analysis upon any changes that might affect the original hazard analysis (applies when a firm does not have a HACCP plan because the original hazard analysis did not reveal hazards likely to occur)	1,840	1	1,840	4	7,360
120.14(a)(2), (c)-(d), and 120.12(b); require that importers of fruit or vegetable juices, or their products used as ingredients in beverages, have written procedures to ensure that the food is processed in accordance with our regulations in part 120	308	1	308	4	1,232
120.8(a)-(b) and 120.12(a)(3), (b)-(c); require written HACCP plan	1,560	1.1	1,716	60	102,960
Total					461,426
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 1 provides our estimate for the next 3 years for the total annual recordkeeping burden of our regulations in part 120. Based on our experience with the information collection over the past 3 years, our burden estimate remains unchanged since our last review of the information collection.

Dated: February 24, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.