[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