[Federal Register: November 24, 2003 (Volume 68, Number 226)]
[Notices]
[Page 65937-65938]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no03-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0318]
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.
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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: Fax written comments on the collection of information by
December 24, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 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 burdens have been estimated using typical small
seafood processing firms as a model because these firms represent a
significant proportion of the industry.
The burden estimate in table 1 of this document includes only those
[[Page 65938]]
collections of information under the seafood HACCP regulations that are
not already required under other statutes and regulations. For example,
the current food manufacturing practices provisions in 21 CFR part 110
already require that all food processors ensure good sanitary practices
and conditions, monitor the quality of incoming materials, monitor and
control food temperatures to prevent bacterial growth, and perform
certain corrective actions and verification procedures. Furthermore,
the estimate 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 new
information collection and recording requirements attributable to part
123.
In the Federal Register of July 28, 2003 (68 FR 44341), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Estimated Annual Recordkeeping Burden\1,3\
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Annual Frequency
21 CFR Section No. of of Total Annual Hours per Total Hours Total Operating &
Recordkeepers Recordkeeping\1\ Records Recordkeeper\2\ Maintenance Costs
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123.6(a), (b), and (c) 243 1 243 16.00 3,888 $58,320.00
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123.6(c)(5) 4,850 4 19,400 0.30 5,820 $87,300.00
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123.8(a)(1), and (c) 4,850 1 4,850 4.00 19,400 $291,000.00
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123.12(a)(2)(ii) 1,000 80 80,000 0.20 16,000 $240,000.00
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123.6(c)(7) 4,850 280 1,358,000 0.30 407,400 $6,111,000.00
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123.7(d) 1,940 4 7,760 0.10 1,940 $29,100.00
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123.8(d) 4,850 47 227,950 0.10 22,795 $341,925.00
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123.11(c) 4,850 280 1,358,000 0.10 135,800 $2,037,000.00
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123.12(c) 1,000 80 80,000 0.10 8,000 $120,000.00
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123.12(a)(2) 50 1 50 4.00 200 $3,000.00
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123.10 243 1 24 24.00 5,832 $87,480.00
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Annual Burden Hours ................. ................. ................. ................. 627,075 $9,406,125.00
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\1\The above estimates include the information collection requirements in the following sections:
Sec. 123.16-Smoked Fish--process controls (see 123.6(b))
Sec. 123.28(a)-Source Controls--Molluscan Shellfish (see 123.6(b))
Sec. 123.28(c),(d)-Records--molluscan shellfish (see 123.6(c)(7))
Based on an estimated 280 working days per year.
\2\ Estimated average time per 8 hour work day unless one time response
\3\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29195 Filed 11-21-03; 8:45 am]
BILLING CODE 4160-01-S