[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6760-6761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02051]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0879]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Procedures for the
Safe Processing and Importing of Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 March 3, 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 0910-0354. 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,
[email protected].
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 Processing and Importing of Fish and Fishery
Products--21 CFR Part 123
OMB Control Number 0910-0354--Extension
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)). 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
[[Page 6761]]
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 (21 CFR 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 Sec. 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 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 information that are a usual and
customary part of businesses' normal activities. For example, the
tagging and labeling of molluscan shellfish (Sec. 1240.60 (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.
Description of Respondents: Respondents to this collection of
information include processors and importers of seafood.
In the Federal Register of August 2, 2022 (87 FR 47214), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Number of records per Total annual
21 CFR section; \2\ activity recordkeepers recordkeeper records Average burden per recordkeeping \4\ Total hours
\3\
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123.6(a), (b), and (c); Prepare hazard 50 1 50 16....................................... 800
analysis and HACCP plan.
123.6(c)(5); Undertake and prepare records of 15,000 4 60,000 0.30 (18 minutes)........................ 18,000
corrective actions.
123.8(a)(1) and (c); Reassess hazard analysis 15,000 1 15,000 4........................................ 60,000
and HACCP plan.
123.12(a)(2)(ii); Verify compliance of 4,100 80 328,000 0.20 (12 minutes)........................ 65,600
imports and prepare records of verification
activities.
123.6(c)(7); Document monitoring of critical 15,000 280 4,200,000 0.30 (18 minutes)........................ 1,260,000
control points.
123.7(d); Undertake and prepare records of 6,000 4 24,000 0.10 (6 minutes)......................... 2,400
corrective actions due to a deviation from a
critical limit.
123.8(d); Maintain records of the calibration 15,000 47 705,000 0.10 (6 minutes)......................... 70,500
of process-monitoring instruments and the
performing of any periodic end-product and
in-process testing.
123.11(c); Maintain sanitation control 15,000 280 4,200,000 0.10 (6 minutes)......................... 420,000
records.
123.12(c); Maintain records that verify that 4,100 80 328,000 0.10 (6 minutes)......................... 32,800
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.
123.12(a)(2); Prepare new written 41 1 41 4........................................ 164
verification procedures to verify compliance
of imports.
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Total.................................... .............. .............. .............. ......................................... 1,930,264
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\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:
Sec. 123.16--Smoked Fish--process controls (see Sec. 123.6(b));
Sec. 123.28(a)--Source Controls--molluscan shellfish (see Sec. 123.6(b));
Sec. 123.28(c) and (d)--Records--molluscan shellfish (see Sec. 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.
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 (Sec. 1240.60) is a customary and usual practice among
seafood processors.
Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02051 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P