[Federal Register Volume 65, Number 141 (Friday, July 21, 2000)]
[Notices]
[Pages 45382-45384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1379]


Agency Information Collection Activities; Proposed Collection; 
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 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 under the provisions of FDA's fish and 
fishery products regulations.

DATES: Submit written comments on the collection of information by 
September 19, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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

[[Page 45383]]

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 (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 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 
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 includes only those 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 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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                                                            Annual frequency
              21 CFR Section                    No. of             per           Total annual         Hours per       Total hours    Total operating and
                                             recordkeepers  recordkeeping\2\        records        recordkeeper\3\                    maintenance costs
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123.6(a), (b), and (c)                          243                1                243                 16            3,888            $58,320
123.6(c)(5)                                   4,850                4             19,400                  0.30         5,820            $87,300
123.8(a)(1) and (c)                           4,850                1              4,850                  4           19,400           $291,000
123.12(a)(2)(ii)                              1,000               80             80,000                  0.20        16,000           $240,000
123.6(c)(7)                                   4,850              280          1,358,000                  0.30       407,400         $6,111,000
123.7(d)                                      1,940                4              7,760                  0.10         1,940            $29,100
123.8(d)                                      4,850               47            227,950                  0.10        22,795           $341,925
123.11(c)                                     4,850              280          1,358,000                  0.10       135,800         $2,037,000
123.12(c)                                     1,000               80             80,000                  0.10         8,000           $120,000
123.12(a)(2)                                     50                1                 50                  4              200             $3,000
123.10                                          243                1                 24                 24            5,832            $87,480
Annual burden hours                                                                                                 627,075         $9,406,125
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\1\There are no capital costs associated with this collection of information.
\2\Based on an estimated 280 working days per year.
\3\Estimated average time per 8-hour work day unless one time response.
The above 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))

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Sec.  123.28(c), (d) Records--molluscan shellfish (see Sec.  123.6(c)(7))


    Dated: July 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-18459 Filed 7-20-00; 8:45 am]
BILLING CODE 4160-01-F