[Federal Register Volume 75, Number 68 (Friday, April 9, 2010)]
[Notices]
[Pages 18211-18213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8051]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0182]


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 the information collection 
provisions of FDA's regulations requiring reporting and recordkeeping 
for processors and importers of fish and fishery products.

DATES:  Submit written or electronic comments on the collection of 
information by June 8, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 these topics: (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 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)).
    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 on 
the nature of the equipment or instruments required to monitor critical 
control points. The burden estimate in table 1 of this document 
includes only those collections of information under the seafood HACCP 
regulations that are not already required under other statutes and 
regulations. The estimate also 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 information collection and recording requirements attributable to 
part 123.
    Description of Respondents: Respondents to this collection of 
information include processors and importers of seafood.
    FDA estimates the burden of this collection of information as 
follows:

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                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours Per
                   21 CFR Section\2\                      Recordkeepers    per Recordkeeping\3\       Records           Record\4\         Total Hours
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123.6(a),(b), and (c)                                                  50                     1                 50              16.00                800
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123.6(c)(5)                                                        15,000                     4             60,000               0.30             18,000
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123.8(a)(1) and (c)                                                15,000                     1             15,000               4.00             60,000
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123.12(a)(2)(ii)                                                    4,100                    80            328,000               0.20             65,600
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123.6(c)(7)                                                        15,000                   280          4,200,000               0.30          1,260,000
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123.7(d)                                                            6,000                     4             24,000               0.10              2,400
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123.8(d)                                                           15,000                    47            705,000               0.10             70,500
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123.11(c)                                                          15,000                   280          4,200,000               0.10            420,000
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123.12(c)                                                           4,100                    80            328,000               0.10             32,800
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123.12(a)(2)                                                           41                     1                 41               4.00                164
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Total                                                                                                                                          1,930,264
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ 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)).
\3\ Based on an estimated 280 working days per year.
\4\ Estimated average time per 8-hour work day unless one-time response.

    FDA bases this hour burden estimate on its experience with the 
application of HACCP principles in food processing. Further, 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 hour burden of HACCP recordkeeping activities will 
vary considerably among processors and importers of fish and fishery 
products, depending on the size of the facility and complexity of the 
HACCP control scheme (i.e., the number of products and the number of 
hazards controlled); the daily frequency that control points are 
monitored and values recorded; and also on the extent that data 
recording time and cost are minimized by the use of automated data 
logging technology. The burden estimate does not include burden hours 
for activities 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.
    Based on its records, FDA estimates that there are 15,000 
processors and 4,100 importers.
    FDA estimates that 50 processors will undertake the initial 
preparation of a hazard analysis and HAACP plan (Sec.  123.6(a),(b), 
and (c)). FDA estimates the burden for the initial preparation of a 
hazard analysis and HAACP plan to be 16 hours per processor for a total 
burden of 800 hours. FDA estimates that all processors (15,000 
processors) will undertake and keep records of 4 corrective action 
plans (Sec.  123.6(c)(5)) for a total of 60,000 records. FDA estimates 
the burden for the preparation of each record to be 0.30 hours for a 
total burden of 18,000 hours.
    FDA estimates that all processors (15,000 processors) will annually 
reassess their hazard analysis and HACCP plan (Sec.  123.8(a)(1) and 
(c)). FDA estimates the burden for the reassessment of the hazard 
analysis and HAACP plan to be 4 hours per processor for a total burden 
of 60,000 hours.
    FDA estimates that all importers (4,100 importers) will take 
affirmative steps to verify compliance of imports and prepare 80 
records of their verification activities (Sec.  123.12(a)(2)(ii)) for a 
total of 328,000 records. FDA estimates the burden for the preparation 
of each record to be 0.20 hours for a total burden of 65,600 hours.
    FDA estimates that all processors (15,000 processors) will document 
the monitoring of critical control points (Sec.  123.6(c)(7)) at 280 
records per processor for a total of 4,200,000 records. FDA estimates 
the burden for the preparation of each record to be 0.30 hours for a 
total burden of 1,260,000 hours.
    FDA estimates that 40 percent of all processors (6,000 processors) 
will maintain records of any corrective actions taken due to a 
deviation from a critical limit (Sec.  123.7(d)) at 4 records per 
processor for a total of 24,000 records. FDA estimates the burden for 
the preparation of each record to be 0.10 hours for a total burden of 
2,400 hours.
    FDA estimates that all processors (15,000 processors) will maintain 
records of the calibration of process-monitoring instruments and the 
performing of any periodic end-product and in-process testing (Sec.  
123.8(d)) at 47 records per processor for a total of 705,000 records. 
FDA estimates the burden for the preparation of each record to be 0.10 
hours for a total burden of 70,500 hours.
    FDA estimates that all processors (15,000 processors) will maintain 
sanitation control records (Sec.  123.11(c)) at 280 records per 
processor for a total of 4,200,000 records. FDA estimates the burden 
for the preparation of each record to be 0.10 hours for a total burden 
of 420,000 hours.
    FDA estimates that all importers (4,100 importers) will 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 (Sec.  
123.12(c)). FDA estimates that 80 records will be prepared per importer 
for a total of 328,000 records. FDA estimates the burden for the 
preparation

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of each record to be 0.10 hours for a total burden of 32,800 hours.
    FDA estimates that 1 percent of all importers (41 importers) will 
require new written verification procedures to verify compliance of 
imports (Sec.  123.12(a)(2)). FDA estimates the burden for preparing 
the new procedures to be 4 hours per importer for a total burden of 164 
hours.

    Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8051 Filed 4-8-10; 8:45 am]
BILLING CODE 4160-01-S