
[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47701-47703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18837]



[[Page 47701]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0879]


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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. Under the Paperwork Reduction Act of 1995 (the PRA), 
Federal Agencies must publish a notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, and allow 
60 days for public comment. This notice invites comments on the 
information collection provisions of our regulations requiring 
reporting and recordkeeping for processors and importers of fish and 
fishery products.

DATES: Submit either electronic or written comments on the collection 
of information by October 7, 2013.

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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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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                                                                 Number of
                                                 Number of      records per    Total  annual
             21 CFR Section \2\                recordkeepers   recordkeeper       records       Average  burden per  recordkeeping \4\     Total  hours
                                                                    \3\
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123.6(a),(b), and (c); Prepare hazard                     50               1              50  16........................................             800
 analysis and HACCP plan.
123.6(c)(5); Undertake and prepare records            15,000               4          60,000  0.30 (18 minutes).........................          18,000
 of corrective actions.
123.8(a)(1) and (c); Reassess hazard                  15,000               1          15,000  4.........................................          60,000
 analysis and HACCP plan.
123.12(a)(2)(ii); Verify compliance of                 4,100              80         328,000  0.20 (12 minutes).........................          65,600
 imports and prepare records of verification
 activities.
123.6(c)(7); Document monitoring of critical          15,000             280       4,200,000  0.30 (18 minutes).........................       1,260,000
 control points.
123.7(d); Undertake and prepare records of             6,000               4          24,000  0.10 (6 minutes)..........................           2,400
 corrective actions due to a deviation from
 a critical limit.
123.8(d); Maintain records of the                     15,000              47         705,000  0.10 (6 minutes)..........................          70,500
 calibration of process-monitoring
 instruments and the performing of any
 periodic end-product and in-process testing.
123.11(c); Maintain sanitation control                15,000             280       4,200,000  0.10 (6 minutes)..........................         420,000
 records.
123.12(c); Maintain records that verify that           4,100              80         328,000  0.10 (6 minutes)..........................          32,800
 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.
123.12(a)(2); Prepare new written                         41               1              41  4.........................................             164
 verification procedures to verify
 compliance of imports.
                                             -----------------------------------------------------------------------------------------------------------
    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.

    We base 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 our records, we estimate that there are 15,000 processors 
and 4,100 importers. We estimate that 50 processors will undertake the 
initial preparation of a hazard analysis and HACCP plan (Sec.  
123.6(a), (b), and (c)). We estimate the burden for the initial 
preparation of a hazard analysis and HACCP plan to be 16 hours per 
processor for a total burden of 800 hours. We estimate that all 
processors (15,000 processors) will undertake and keep records of four 
corrective action plans (Sec.  123.6(c)(5)) for a total of 60,000 
records. We estimate the burden for the preparation of each record to 
be 0.30 hours for a total burden of 18,000 hours.
    We estimate that all processors (15,000 processors) will annually 
reassess their hazard analysis and HACCP plan (Sec.  123.8(a)(1) and 
(c)). We estimate 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.
    We estimate 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. We estimate the burden for the preparation of 
each record to be 0.20 hours for a total burden of 65,600 hours.
    We estimate 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. We estimate the 
burden for the preparation of each record to be 0.30 hours for a total 
burden of 1,260,000 hours.
    We estimate 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 four records per 
processor for a total of 24,000 records. We estimate the burden for the 
preparation of each record to be 0.10 hours for a total burden of 2,400 
hours.
    We estimate 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. 
We estimate the burden for the preparation of each record to be 0.10 
hours for a total burden of 70,500 hours.
    We estimate that all processors (15,000 processors) will maintain

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sanitation control records (Sec.  123.11(c)) at 280 records per 
processor for a total of 4,200,000 records. We estimate the burden for 
the preparation of each record to be 0.10 hours for a total burden of 
420,000 hours.
    We estimate 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 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 of each 
record to be 0.10 hours for a total burden of 32,800 hours.
    We estimate that 1 percent of all importers (41 importers) will 
require new written verification procedures to verify compliance of 
imports (Sec.  123.12(a)(2)). We estimate the burden for preparing the 
new procedures to be 4 hours per importer for a total burden of 164 
hours.

    Dated: July 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18837 Filed 8-5-13; 8:45 am]
BILLING CODE 4160-01-P


