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, 96015-96017 [2016-31424]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
the specific manufacturing operations
conducted at the establishment.
We believe the required electronic
MEI can be consolidated to appear in a
single location to facilitate the complete,
timely, and accurate review of all
manufacturing establishments involved
in the preparation of a drug or biological
product. This will help to eliminate the
inclusion and/or maintenance of
potentially outdated and erroneous
information that could be retrieved from
other Agency files and will enable
proper identification and timely
evaluation of manufacturing
establishments for conformance with
requirements, including current good
manufacturing practices.
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The draft
guidance discusses the electronic
submission of MEI contained in an
NDA, ANDA, or BLA to the Center for
Drug Evaluation and Research and the
Center for Biologics Evaluation and
Research by specifying the format for
the electronic submission of such
submissions. The information collection
discussed in the guidance is contained
in our NDA and ANDA regulations (part
314) and approved under OMB control
number 0910–0001, and our BLA
regulations (part 601) and approved
under OMB control number 0910–0338.
Currently, MEI is submitted as part of
the existing application form, Form FDA
356h, and is approved by OMB under
control number 0910–0338.
III. Electronic Access
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31626 Filed 12–28–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
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.
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.
SUMMARY:
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,
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
96015
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 § 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
E:\FR\FM\29DEN1.SGM
29DEN1
96016
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
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
recordkeepers
Number of
records per
recordkeeper 3
50
1
50
16 ...........................
800
15,000
4
60,000
18,000
15,000
1
15,000
.30 ..........................
(18 minutes)
4 .............................
4,100
80
328,000
65,600
15,000
280
4,200,000
6,000
4
24,000
15,000
47
705,000
.20 ..........................
(12 minutes)
.30 ..........................
(18 minutes)
.10 ..........................
(6 minutes)
.10 ..........................
(6 minutes)
15,000
280
4,200,000
123.12(c); 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.
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports.
4,100
80
328,000
41
1
Total ......................................................................
........................
........................
21 CFR Section 2
123.6(a), (b), and (c); Prepare hazard analysis and
HACCP plan.
123.6(c)(5); Undertake and prepare records of corrective actions.
123.8(a)(1) and (c); Reassess hazard analysis and
HACCP plan.
123.12(a)(2)(ii); Verify compliance of imports and
prepare records of verification activities.
123.6(c)(7); Document monitoring of critical control
points.
123.7(d); Undertake and prepare records of corrective actions due to a deviation from a critical limit.
123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of
any periodic end-product and in-process testing.
123.11(c); Maintain sanitation control records ............
Total annual
records
Average burden per
recordkeeping 4
Total hours
60,000
1,260,000
2,400
70,500
.10 ..........................
(6 minutes)
.10 ..........................
(6 minutes)
420,000
41
4 .............................
164
........................
................................
1,930,264
32,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates include the information collection requirements in the following sections:
§ 123.16—Smoked Fish—process controls (see § 123.6(b));
§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b));
§ 123.28(c) and (d)—Records—molluscan shellfish (see § 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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
2 These
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
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
molluscan shellfish (§ 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 (§ 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 (§ 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
(§ 123.8(a)(1) and (c)). We estimate the
burden for the reassessment of the
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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 (§ 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
(§ 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 (§ 123.7(d)) at 4 records per
E:\FR\FM\29DEN1.SGM
29DEN1
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
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 processmonitoring instruments and the
performing of any periodic end-product
and in-process testing (§ 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 (§ 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
(§ 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
(§ 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.
entitled ‘‘Submission of Warning Plans
for Cigars.’’ The guidance will help
those involved in the manufacture,
distribution, and sale of cigars in the
United States understand the new cigar
warning plan requirements under FDA’s
final rule deeming these products to be
subject to the tobacco product
authorities in the Federal Food, Drug,
and Cosmetic Act (the FD&C Act). The
guidance reiterates the health warning
statements and display and distribution
requirements that should be provided in
cigar warning plans and will help
persons determine who should submit a
warning plan, when a plan must be
submitted, and what information should
be included when submitting a plan.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Food and Drug Administration
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’’).
[Docket No. FDA–2016–D–2495]
Written/Paper Submissions
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission of Warning Plans for
Cigars; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
SUMMARY:
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
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,
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
96017
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–
2016–D–2495 for ‘‘Submission of
Warning Plans for Cigars; Guidance for
Industry.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
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 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: https://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 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
