E7-3915. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products

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 6, 2007.

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].

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products—21 CFR Part 123 (OMB Control Number 0910-0354)—Extension

FDA regulations in part 123 (21 CFR part 123) 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 (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)), and became effective on December 18, 1997.

Certain provisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor's HACCP plan (e.g., the values for processing times, temperatures, acidity, etc., as observed at critical control points). The primary purpose of HACCP records is to permit a processor to verify that products have been produced within carefully established processing parameters (critical limits) that ensure that hazards have been avoided. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained, or that appropriate corrective actions were taken if the critical limits were not maintained. Such verification activities are essential to ensure that the HACCP system is working as planned. A review of these records during the conduct of periodic plant inspections also permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls.

Section 123.12 requires that importers of seafood products take affirmative steps and 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. These records are also to be made available for review by FDA as provided in § 123.12(c).

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 burdens have been estimated using typical small seafood processing firms as a model because these firms represent a significant proportion of the industry. Costs were estimated for the collection of HACCP data for each type of recordkeeping activity using a labor cost of $15.00 per hour.

The burden estimate in table 1 of this document 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 information 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 of this document account only for information collection and recording requirements attributable to part 123.

Upon reevaluation of the burden estimates for part 123, we have determined that PRA requirements do not apply to § 123.10.

In the Federal Register of September 26, 2006 (71 FR 56154), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

Table 1.—Estimated Annual Recordkeeping Burden¹

21 CFR Section2	No. of Recordkeepers	Annual Frequency per Recordkeeping3	Total Annual Records	Hours per Record4	Total Hours
123.6(a), (b), and (c)	275	1	275	16.00	4,400
123.6(c)(5)	5,500	4	22,000	0.30	6,600
123.8(a)(1) and (c)	5,500	1	5,500	4.00	22,000
123.12(a)(2)(ii)	1,100	80	88,000	0.20	17,600
123.6(c)(7)	5,500	280	1,540,000	0.30	462,000
123.7(d)	2,200	4	8,800	0.10	880
123.8(d)	5,500	47	258,500	0.10	25,850
123.11(c)	5,500	280	1,540,000	0.10	154,000
123.12(c)	1,100	80	88,000	0.10	8,800
123.12(a)(2)	55	1	55	4.00	220
TOTAL					702,350
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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))
3 Based on an estimated 280 working days per year.
4 Estimated average time per 8-hour workday unless one-time response.

Dated: February 27, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.