Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 47701-47703 [2013-18837]
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
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.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies must publish a
notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and allow 60 days for
public comment. 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 October 7, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
SUMMARY:
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
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SUPPLEMENTARY INFORMATION:
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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, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the following
collection of information we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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 (a)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (a)(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
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47701
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 of this
document 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:
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06AUN1
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Total
annual
records
Average
burden per
recordkeeping 4
Number of
recordkeepers
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 ........
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.
Total ..................................................................
Number of
records per
recordkeeper 3
50
1
50
16 ..............................
800
15,000
4
60,000
0.30 (18 minutes) ......
18,000
15,000
1
15,000
4 ................................
60,000
4,100
80
328,000
0.20 (12 minutes) ......
65,600
15,000
280
4,200,000
0.30 (18 minutes) ......
1,260,000
6,000
4
24,000
0.10 (6 minutes) ........
2,400
15,000
47
705,000
0.10 (6 minutes) ........
70,500
15,000
4,100
280
80
4,200,000
328,000
0.10 (6 minutes) ........
0.10 (6 minutes) ........
420,000
32,800
41
1
41
4 ................................
164
........................
........................
........................
....................................
1,930,264
Total
hours
1 There
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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:
§ 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.
We base this hour burden estimate on
its 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 (21 CFR 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
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processors will undertake the initial
preparation of a hazard analysis and
HACCP plan (§ 123.6(a), (b), and (c)).
We estimate the burden for the initial
preparation of a hazard analysis and
HACCP 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 0.30
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 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 0.20 hours for a total
burden of 65,600 hours.
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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 0.30
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 four records
per processor for a total of 24,000
records. We estimate the burden for the
preparation of each record to be 0.10
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 0.10 hours for a total
burden of 70,500 hours.
We estimate that all processors
(15,000 processors) will maintain
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
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 0.10 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 § 123.12(c). FDA
estimates that 80 records will be
prepared per importer for a total of
328,000 records. FDA estimates the
burden for the preparation of each
record to be 0.10 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.
Dated: July 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18837 Filed 8–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451] (formerly
2004N–0226)
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
031
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
I. Background
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 031’’ (Recognition List
Number: 031), will assist manufacturers
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SUMMARY:
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who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit written or electronic
comments concerning this document at
any time. See section VII for the
effective date of the recognition of
standards announced in this document.
ADDRESSES: Submit written requests for
single copies of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 031’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993. Send two selfaddressed adhesive labels to assist that
office in processing your requests, or fax
your request to 301–847–8149. Submit
written comments concerning this
document, or recommendations for
additional standards for recognition, to
the contact person (see FOR FURTHER
INFORMATION CONTACT). Submit
electronic comments by email:
standards@cdrh.fda.gov. This document
may also be accessed on FDA’s Internet
site at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI for electronic access to the searchable
database for the current list of FDA
recognized consensus standards,
including Recognition List Number: 031
modifications and other standards
related information.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 3632, Silver Spring,
MD 20993, 301–796–6287.
SUPPLEMENTARY INFORMATION:
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Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize
consensus standards developed by
international and national organizations
for use in satisfying portions of device
premarket review submissions or other
requirements.
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47703
In a notice published in the Federal
Register of February 25, 1998 (63 FR
9561), FDA announced the availability
of a guidance entitled ‘‘Recognition and
Use of Consensus Standards.’’ The
notice described how FDA would
implement its standard recognition
program and provided the initial list of
recognized standards.
Modifications to the initial list of
recognized standards, as published in
the Federal Register, can be accessed at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
These notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains ‘‘hypertext markup
language (HTML)’’ and ‘‘portable
document format (PDF)’’ versions of the
list of ‘‘FDA Recognized Consensus
Standards.’’ Both versions are publicly
accessible at the Agency’s Internet site.
See section VI for electronic access
information. Interested persons should
review the supplementary information
sheet for the standard to understand
fully the extent to which FDA
recognizes the standard.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 031
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
will recognize for use in premarket
submissions and other requirements for
devices. FDA will incorporate these
modifications in the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database. FDA will
use the term ‘‘Recognition List Number:
031’’ to identify these current
modifications.
In table 1, FDA describes the
following modifications: (1) The
withdrawal of standards and their
replacement by others, if applicable; (2)
the correction of errors made by FDA in
listing previously recognized standards;
and (3) the changes to the
supplementary information sheets of
recognized standards that describe
revisions to the applicability of the
standards.
In section III, FDA lists modifications
the Agency is making that involve the
initial addition of standards not
previously recognized by FDA.
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]]>Agencies
[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47701-47703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18837]
[[Page 47701]]
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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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the PRA),
Federal Agencies must publish a notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and allow
60 days for public comment. 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 October 7, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
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, we are publishing this notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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 (a)(4) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(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 of this document
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 47702]]
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 15,000 4 60,000 0.30 (18 minutes)......................... 18,000
of corrective actions.
123.8(a)(1) and (c); Reassess hazard 15,000 1 15,000 4......................................... 60,000
analysis and HACCP plan.
123.12(a)(2)(ii); Verify compliance of 4,100 80 328,000 0.20 (12 minutes)......................... 65,600
imports 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 15,000 47 705,000 0.10 (6 minutes).......................... 70,500
calibration of process-monitoring
instruments and the performing of any
periodic end-product and in-process testing.
123.11(c); Maintain sanitation control 15,000 280 4,200,000 0.10 (6 minutes).......................... 420,000
records.
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 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 its 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 (21 CFR 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 HACCP plan (Sec.
123.6(a), (b), and (c)). We estimate the burden for the initial
preparation of a hazard analysis and HACCP 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 0.30 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 0.20 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 0.30 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 four records per
processor for a total of 24,000 records. We estimate the burden for the
preparation of each record to be 0.10 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 0.10
hours for a total burden of 70,500 hours.
We estimate that all processors (15,000 processors) will maintain
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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 0.10 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 Sec. 123.12(c). FDA
estimates that 80 records will be prepared per importer for a total of
328,000 records. FDA estimates the burden for the preparation of each
record to be 0.10 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 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18837 Filed 8-5-13; 8:45 am]
BILLING CODE 4160-01-P
