[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65820-65821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 30, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0354. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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

    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 information that are a usual and 
customary part of businesses' normal activities. For example, the 
tagging and labeling of molluscan shellfish (Sec.  1240.60 (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.
    In the Federal Register of September 4, 2019 (84 FR 46544), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

[[Page 65821]]



                                                   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)-(c); Prepare hazard analysis and HACCP              50               1              50  16.....................................             800
 plan.
123.6(c)(5); Undertake and prepare records of            15,000               4          60,000  0.30 (18 minutes)......................          18,000
 corrective actions.
123.8(a)(1) and (c); Reassess hazard analysis            15,000               1          15,000  4......................................          60,000
 and HACCP plan.
123.12(a)(2)(ii); Verify compliance of imports            4,100              80         328,000  0.20 (12 minutes)......................          65,600
 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 calibration            15,000              47         705,000  0.10 (6 minutes).......................          70,500
 of process-monitoring instruments and the
 performing of any periodic end-product and in-
 process testing.
123.11(c); Maintain sanitation control records.          15,000             280       4,200,000  0.10 (6 minutes).......................         420,000
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 verification               41               1              41  4......................................             164
 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: November 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25857 Filed 11-27-19; 8:45 am]
 BILLING CODE 4164-01-P


