[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46544-46546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18987]


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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection associated with safe 
and sanitary processing and importing of fish and fishery products.

DATES: Submit either electronic or written comments on the collection 
of information by November 4, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 4, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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:

[[Page 46545]]

     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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

    This information collection supports regulations in part 123 (21 
CFR part 123), which 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

[[Page 46546]]

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.
    We estimate the burden of this collection of information as 
follows:

                                Table 1--Estimated Annual Recordkeeping Burden 1
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                                                    Number of records     Total      Average burden
       21 CFR Section \2\            Number of       per recordkeeper    annual    per recordkeeping     Total
                                   recordkeepers           \3\           records          \4\            hours
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123.6(a), (b), and (c); Prepare                 50                  1          50                 16         800
 hazard analysis and HACCP
 plan..........................
123.6(c)(5); Undertake and                  15,000                  4      60,000               0.30      18,000
 prepare records of corrective                                                          (18 minutes)
 actions.......................
123.8(a)(1) and (c); Reassess               15,000                  1      15,000                  4      60,000
 hazard analysis and HACCP
 plan..........................
123.12(a)(2)(ii); Verify                     4,100                 80     328,000               0.20      65,600
 compliance of imports and                                                              (12 minutes)
 prepare records of
 verification activities.......
123.6(c)(7); Document                       15,000                280   4,200,000               0.30   1,260,000
 monitoring of critical control                                                         (18 minutes)
 points........................
123.7(d); Undertake and prepare              6,000                  4      24,000               0.10       2,400
 records of corrective actions                                                           (6 minutes)
 due to a deviation from a
 critical limit................
123.8(d); Maintain records of               15,000                 47     705,000               0.10      70,500
 the calibration of process-                                                             (6 minutes)
 monitoring instruments and the
 performing of any periodic end-
 product and in-process
 testing.......................
123.11(c); Maintain sanitation              15,000                280   4,200,000               0.10     420,000
 control records...............                                                          (6 minutes)
123.12(c); Maintain records                  4,100                 80     328,000               0.10      32,800
 that verify that the fish and                                                           (6 minutes)
 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.

    Based on a review of the information collection since our last OMB 
approval, we have made no adjustments to our burden estimate. 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.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18987 Filed 9-3-19; 8:45 am]
 BILLING CODE 4164-01-P