[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Notices]
[Pages 44341-44342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19032]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0318]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 extending the existing
reporting and recordkeeping requirements for processors and importers
of fish and fishery products.
DATES: Submit written or electronic comments on the collection of
information by September 26, 2003.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with
the docket number found in brackets in the heading of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques when appropriate, and other forms of
information technology.
Procedures for the Safe 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
collections of information under the
[[Page 44342]]
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 account
only for new information collection and recording requirements
attributable to part 123.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Total Operating
No. of Annual Frequency Total Annual Hours per and Maintenance
21 CFR Section Recordkeepers of Records Recordkeeper\3\ Total Hours Costs (in
Recordkeeping\2\ dollars)
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123.6(a), (b), and (c) 243 1 243 16.00 3,888 58,320
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123.6(c)(5) 4,850 4 19,400 0.30 5,820 87,300
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123.8(a)(1) and (c) 4,850 1 4,850 4.00 19,400 291,000
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123.12(a)(2)(ii) 1,000 80 80,000 0.20 16,000 240,000
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123.6(c)(7) 4,850 280 1,358,000 0.30 407,400 6,111,000
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123.7(d) 1,940 4 7,760 0.10 1,940 29,100
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123.8(d) 4,850 47 227,950 0.10 22,795 341,925
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123.11(c) 4,850 280 1,358,000 0.10 135,800 2,037,000
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123.12(c) 1,000 80 80,000 0.10 8,000 120,000
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123.12(a)(2) 50 1 50 4.00 200 3,000
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123.10 243 1 24 24.00 5,832 87,480
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Annual burden hours .......... 627,075 9,406,125
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\1\ 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))
\2\ Based on an estimated 280 working days per year.
\3\ Estimated average time per 8 hour work day unless one time response.
Dated: July 21, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19032 Filed 7-25-03; 8:45 am]
BILLING CODE 4160-01-S