2017-05105. 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) 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:

Fax written comments on the collection of information by April 14, 2017.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0466. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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

FDA's regulations in part 120 (21 CFR part 120) 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 that 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 the Federal Register of August 30, 2016 (81 FR 59636), 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	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) and (c)—Require written hazard analysis of food hazards	2,300	1.1	2,530	20	50,600
120.8(a) and 20.12(a)(3), (b), and (c)—Require written HACCP plan	1,560	1.1	1716	60	102,960
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 verification activities associated with the HACCP system	1,840	52	95,680	0.1 (6 minutes)	9,568
120.11(b) and 120.12(a)(5) and (b)—Require records showing validation activities associated with the HACCP system	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), and (d) and 120.12(b)—Require that juice importers have written procedures to ensure that the juice is processed in accordance with our regulations in part 120	308	1	308	4	1,232
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 of the total annual recordkeeping burden of our regulations in part 120. We base our estimate of the average burden per recordkeeping on our experience with the application of HACCP principles in food processing. We base our estimate of the number of recordkeepers on our estimate of the total number of juice manufacturing plants affected by the regulations (plants identified in our official establishment inventory plus very small apple juice and very small orange juice manufacturers). These estimates assume that every processor will prepare sanitary standard operating procedures and an HACCP plan and maintain the associated monitoring records, and that every importer will require product safety specifications. In fact, there are likely to be some small number of juice processors that, based upon their hazard analysis, determine that they are not required to have an HACCP plan under these regulations.

Dated: March 9, 2017.

Leslie Kux,

Associate Commissioner for Policy.