[Federal Register Volume 68, Number 226 (Monday, November 24, 2003)]
[Notices]
[Pages 65937-65938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29195]


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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