[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......
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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