Source: https://www.federalregister.gov/documents/2019/09/04/2019-18987/agency-information-collection-activities-proposed-collection-comment-request-procedures-for-the-safe
Timestamp: 2019-09-19 23:57:49
Document Index: 65403441

Matched Legal Cases: ['art 123', 'art 123', 'art 123', 'art 123', '§\u2009123', '§\u2009123', '§\u2009123', '§\u2009123', '§\u2009123', '§\u2009123', '§\u20091240']

84 FR 46544
46544-46546 (3 pages)
2019-18987
https://www.federalregister.gov/d/2019-18987 https://www.federalregister.gov/d/2019-18987
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with safe and sanitary processing and importing of fish and fishery products.
Submit written/paper submissions as follows:Start Printed Page 46545
Instructions: All submissions received must include the Docket No. FDA-2013-N-0879 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
This information collection supports regulations in part 123 (21 CFR part 123), which mandate the application of hazard analysis and critical control point (HACCP) principles to the processing of seafood. HACCP is a preventive 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, including section 402(a)(1) and (4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
The time and costs of these recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the type and number of products involved, and on the nature of the equipment or instruments required to monitor critical control points. The burden estimate in table 1 includes only those collections of information under the seafood HACCP regulations that are not already required under other statutes and regulations. The estimate also does not include collections of Start Printed Page 46546information that are a usual and customary part of businesses' normal activities. For example, the tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a customary and usual practice among seafood processors. Consequently, the estimates in table 1 account only for information collection and recording requirements attributable to part 123.
123.6(a), (b), and (c); Prepare hazard analysis and HACCP plan. 50 1 50 16 800
123.6(c)(5); Undertake and prepare records of corrective actions. 15,000 4 60,000 0.30 (18 minutes) 18,000
123.8(a)(1) and (c); Reassess hazard analysis and HACCP plan. 15,000 1 15,000 4 60,000
123.12(a)(2)(ii); Verify compliance of imports and prepare records of verification activities. 4,100 80 328,000 0.20 (12 minutes) 65,600
123.6(c)(7); Document monitoring of critical control points. 15,000 280 4,200,000 0.30 (18 minutes) 1,260,000
123.7(d); Undertake and prepare records of corrective actions due to a deviation from a critical limit. 6,000 4 24,000 0.10 (6 minutes) 2,400
123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing. 15,000 47 705,000 0.10 (6 minutes) 70,500
123.11(c); Maintain sanitation control records. 15,000 280 4,200,000 0.10 (6 minutes) 420,000
123.12(c); Maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123. 4,100 80 328,000 0.10 (6 minutes) 32,800
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports. 41 1 41 4 164
2 These estimates include the information collection requirements in the following sections: § 123.16—Smoked Fish—process controls (see § 123.6(b)); § 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b)); § 123.28(c) and (d)—Records—molluscan shellfish (see § 123.6(c)(7).
Based on a review of the information collection since our last OMB approval, we have made no adjustments to our burden estimate. We base this hour burden estimate on our experience with the application of HACCP principles in food processing. Further, the burdens have been estimated using typical small seafood processing firms as a model because these firms represent a significant proportion of the industry. The hour burden of HACCP recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the size of the facility and complexity of the HACCP control scheme (i.e., the number of products and the number of hazards controlled); the daily frequency that control points are monitored and values recorded; and also on the extent that data recording time and cost are minimized by the use of automated data logging technology. The burden estimate does not include burden hours for activities that are a usual and customary part of businesses' normal activities. For example, the tagging and labeling of molluscan shellfish (§ 1240.60) is a customary and usual practice among seafood processors.
[FR Doc. 2019-18987 Filed 9-3-19; 8:45 am]