
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96015-96017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31424]


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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 January 
30, 2017.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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

    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

[[Page 96016]]

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 July 26, 2016 (81 FR 48816), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                                                  Number of      records per    Total annual
              21 CFR Section \2\                recordkeepers   recordkeeper       records        Average burden per recordkeeping \4\      Total hours
                                                                     \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 of          15,000               4          60,000  .30......................................          18,000
 corrective actions.                                                                           (18 minutes).............................
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                  4,100              80         328,000  .20......................................          65,600
 imports and prepare records of verification                                                   (12 minutes).............................
 activities.
123.6(c)(7); Document monitoring of critical           15,000             280       4,200,000  .30......................................       1,260,000
 control points.                                                                               (18 minutes).............................
123.7(d); Undertake and prepare records of              6,000               4          24,000  .10......................................           2,400
 corrective actions due to a deviation from a                                                  (6 minutes)..............................
 critical limit.
123.8(d); Maintain records of the calibration          15,000              47         705,000  .10......................................          70,500
 of process-monitoring instruments and the                                                     (6 minutes)..............................
 performing of any periodic end-product and
 in-process testing.
123.11(c); Maintain sanitation control                 15,000             280       4,200,000  .10......................................         420,000
 records.                                                                                      (6 minutes)..............................
123.12(c); Maintain records that verify that            4,100              80         328,000  .10......................................          32,800
 the fish and fishery products they offer for                                                  (6 minutes)..............................
 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 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

[[Page 96017]]

processor for a total of 24,000 records. 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: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31424 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P


