[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48816-48819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17571]


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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 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 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 September 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0879 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Procedures for the Safe and 
Sanitary Processing and Importing of Fish and Fishery Products.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be

[[Page 48817]]

made publicly available, submit your comments only as a written/paper 
submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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 (4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (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 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:

[[Page 48818]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                 Number of
                                 Number of      records per    Total annual   Average burden per
     21 CFR Section \2\        recordkeepers   recordkeeper       records      recordkeeping \4\    Total hours
                                                    \3\
----------------------------------------------------------------------------------------------------------------
123.6(a), (b), and (c);                   50               1              50                  16             800
 Prepare hazard analysis and
 HACCP plan.................
123.6(c)(5); Undertake and            15,000               4          60,000                 .30          18,000
 prepare records of                                                                 (18 minutes)
 corrective actions.........
123.8(a)(1) and (c);                  15,000               1          15,000                   4          60,000
 Reassess hazard analysis
 and HACCP plan.............
123.12(a)(2)(ii); Verify               4,100              80         328,000                 .20          65,600
 compliance of imports and                                                          (12 minutes)
 prepare records of
 verification activities....
123.6(c)(7); Document                 15,000             280       4,200,000                 .30       1,260,000
 monitoring of critical                                                             (18 minutes)
 control points.............
123.7(d); Undertake and                6,000               4          24,000                 .10           2,400
 prepare records of                                                                  (6 minutes)
 corrective actions due to a
 deviation from a critical
 limit......................
123.8(d); Maintain records            15,000              47         705,000                 .10          70,500
 of the calibration of                                                               (6 minutes)
 process-monitoring
 instruments and the
 performing of any periodic
 end-product and in-process
 testing....................
123.11(c); Maintain                   15,000             280       4,200,000                 .10         420,000
 sanitation control records.                                                         (6 minutes)
123.12(c); Maintain records            4,100              80         328,000                 .10          32,800
 that verify that the fish                                                           (6 minutes)
 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                 41               1              41                   4             164
 written 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 our 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 (Sec.  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 HAACP plan (Sec.  
123.6(a), (b), and (c)). We estimate 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.
    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 .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 .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 .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 4 records per 
processor for a total of 24,000 records.

[[Page 48819]]

We estimate the burden for the preparation of each record to be .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 .10 
hours for a total burden of 70,500 hours.
    We estimate 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. We estimate the burden for 
the preparation of each record to be .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 part 123 (Sec.  
123.12(c)). We estimate that 80 records will be prepared per importer 
for a total of 328,000 records. We estimate the burden for the 
preparation of each record to be .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 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17571 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P