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, 34746-34748 [2010-14817]
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34746
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
and 2). For example, 41 percent of U.S.
consumers say they have never looked
for any recalled product in their home
(Ref. 2). Conversely, some consumers
overreact to the announcement of a
foodborne illness outbreak or food
recall. In response to the 2006 fresh,
bagged spinach recall which followed a
multistate outbreak of Escherichia coli
O157: H7 infections (Ref. 3), 18 percent
of consumers said they stopped buying
other bagged, fresh produce because of
the spinach recall (Ref. 1).
Research shows that emotion plays a
large role in decisionmaking, and that
individuals may not be conscious of its
effects on their behavior (Ref. 4). For
example, when people are angry they
are likely to place blame, take action,
and want justice to be served (Ref. 5).
If a particular food recall engenders
widespread anger and the anger is
coupled with behavior that is less than
desirable from a food safety or
nutritional standpoint, it is possible that
anger will be the lens through which
future food recall situations are viewed,
thus resulting in similar undesirable
behaviors. Findings from this study will
help FDA understand the emotional
response to food recalls. This will help
FDA to design more effective consumer
food recall messages during and after a
recall.
FDA conducts research and
educational and public information
programs relating to food safety under
its broad statutory authority, set forth in
section 903(b)(2) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 393(b)(2)), to protect the public
health by ensuring that foods are ‘‘safe,
wholesome, sanitary, and properly
labeled,’’ and in section 903(d)(2)(C), to
conduct research relating to foods,
drugs, cosmetics, and devices in
carrying out the act.
FDA plans to survey U.S. consumers
using a Web-based panel of U.S.
households to collect information on
consumers’ cognitive and emotional
reaction to food recalls. The survey will
query consumers on their recollection of
food recalls within the past 5 years;
attitude toward recalled foods;
knowledge about particular food recalls;
behavior during the food recall;
assessment and appraisals of
susceptibility, severity, satisfaction, and
self-efficacy.
The data will be collected using an
online survey. A pool of 10,000
consumers from a Web-based consumer
panel will be screened for eligibility
based on age (18+ years) and familiarity
with recent food recalls. One thousand
of those screened consumers will be
randomly selected to participate in the
survey. The results of the survey will
not be used to generate population
estimates.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Screener
Hours per
Response
Total Hours
1
10,000
.006
60
40
1
40
.167
7
1,000
1
1,000
.167
167
11,040
1
11,040
Survey
Total
234
are no capital costs or operating and maintenance costs associated with this collection of information.
Ten thousand members of a Webbased consumer panel will be screened.
We estimate that it will take a
respondent 20 seconds (.006 hours) to
complete the screening questions, for a
total of 60 hours. We will conduct a pretest of the survey with 40 respondents;
we estimate that it will take a
respondent 10 minutes (.167 hours) to
complete the pre-test, for a total of 7
hours. One thousand (1,000)
respondents will complete the survey.
We estimate that it will take a
respondent 10 minutes (.167 hours) to
complete the survey, for a total of 167
hours. Thus, the total estimated burden
is 234 hours.
II. References
srobinson on DSKHWCL6B1PROD with NOTICES
Total Annual
Responses
10,000
Pre-test
1 There
Annual Frequency
per Response
1. Cuite, C., S. Condry, M. Nucci, et al.,
‘‘Public Response to the Contaminated
Spinach Recall of 2006,’’ Publication number
RR–0107–013, New Brunswick, NJ: Rutgers,
the State University of New Jersey, Food
Policy Institute, 2007.
2. Hallman, W., C. Cuite, and N. Hooker,
‘‘Consumer Responses to Food Recalls: 2009
National Survey Report,’’ Publication number
RR–0109–018, New Brunswick, NJ: Rutgers,
VerDate Mar<15>2010
16:17 Jun 17, 2010
Jkt 220001
the State University of New Jersey, Food
Policy Institute, 2009.
3. Acheson, D., ‘‘Outbreak of Escherichia
coli 0157 Infections Associated With Fresh
Spinach—United States, August-September
2006,’’ 2007 (https://first.fda.gov/cafdas/
documents/Acheson_Spinach_
Outbreak_2006_FDA_pres.ppt).
4. Han, S., J. S. Lerner, and D. Keltner,
‘‘Feelings and Consumer Decision Making:
The Appraisal-Tendency Framework,’’
Journal of Consumer Psychology, 17(3) 158–
168, 2007.
5. Lazurus, R. S., ‘‘Emotion and
Adaptation,’’ New York: Oxford University
Press, 1991.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–14815 Filed 6–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0182]
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 July 19,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
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Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
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 e-mailed 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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products—(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 § 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 (§ 1240.60 (21 CFR
1240.60)) is a customary and usual
practice among seafood processors.
Consequently, the estimates in table 1
account only for information collection
and recording requirements attributable
to part 123. Respondents to this
collection of information include
processors and importers of seafood.
In the Federal Register of April 9,
2010 (75 FR 18211), 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 BURDEN1
21 CFR Section2
No. of
Recordkeepers
123.6(a),(b), and (c)
Annual Frequency
of Recordkeeping3
Total Annual
Records
Hours per
Record4
Total Hours
50
1
50
16.00
800
123.6(c)(5)
15,000
4
60,000
0.30
18,000
123.8(a)(1) and (c)
15,000
1
15,000
4.00
60,000
4,100
80
328,000
0.20
65,600
15,000
280
4,200,000
0.30
1,260,000
123.7(d)
6,000
4
24,000
0.10
2,400
123.8(d)
15,000
47
705,000
0.10
70,500
123.11(c)
15,000
280
4,200,000
0.10
420,000
123.12(c)
4,100
80
328,000
0.10
32,800
41
1
41
4.00
164
123.12(a)(2)(ii)
srobinson on DSKHWCL6B1PROD with NOTICES
123.6(c)(7)
123.12(a)(2)
Total
1,930,264
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)).
2These
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34748
3Based
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
on an estimated 280 working days per year.
average time per 8-hour workday unless one-time response.
srobinson on DSKHWCL6B1PROD with NOTICES
4Estimated
FDA bases 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 (§ 1240.60) is a
customary and usual practice among
seafood processors.
Based on its records, FDA estimates
that there are 15,000 processors and
4,100 importers. FDA estimates that 50
processors will undertake the initial
preparation of a hazard analysis and
HAACP plan (§ 123.6(a),(b), and (c)).
FDA estimates 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. FDA estimates that all processors
(15,000 processors) will undertake and
keep records of 4 corrective action plans
(§ 123.6(c)(5)) for a total of 60,000
records. FDA estimates the burden for
the preparation of each record to be 0.30
hours for a total burden of 18,000 hours.
FDA estimates that all processors
(15,000 processors) will annually
reassess their hazard analysis and
HACCP plan (§ 123.8(a)(1) and (c)). FDA
estimates 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.
FDA estimates 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. FDA
estimates the burden for the preparation
of each record to be 0.20 hours for a
total burden of 65,600 hours.
FDA estimates that all processors
(15,000 processors) will document the
monitoring of critical control points
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(§ 123.6(c)(7)) at 280 records per
processor for a total of 4,200,000
records. FDA estimates the burden for
the preparation of each record to be 0.30
hours for a total burden of 1,260,000
hours.
FDA estimates 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
processor for a total of 24,000 records.
FDA estimates the burden for the
preparation of each record to be 0.10
hours for a total burden of 2,400 hours.
FDA estimates 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. FDA estimates the
burden for the preparation of each
record to be 0.10 hours for a total
burden of 70,500 hours.
FDA estimates 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. FDA estimates the
burden for the preparation of each
record to be 0.10 hours for a total
burden of 420,000 hours.
FDA estimates 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)). 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.
FDA estimates that 1 percent of all
importers (41 importers) will require
new written verification procedures to
verify compliance of imports
(§ 123.12(a)(2)). FDA estimates the
burden for preparing the new
procedures to be 4 hours per importer
for a total burden of 164 hours.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–14817 Filed 6–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; National Institute
of Diabetes and Digestive and Kidney
Diseases Information Clearinghouses
Customer Satisfaction Survey
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to
provide opportunity for public comment
on proposed data collection projects, the
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
the National Institutes of Health (NIH),
is giving public notice that the agency
proposes to request reinstatement of an
information collection activity for
which approval expired on February 28,
2010.
Proposed Collection
Title: NIDDK Information
Clearinghouses Customer Satisfaction
Survey. Type of Information Requested:
Reinstatement, with change, of a
previously approved collection for
which approval has expired. The OMB
control number 0925–0480 expired on
February 28, 2010. Need and Use of
Information Collection: NIDDK is
conducting a survey to assess the
efficiency and effectiveness of services
provided by NIDDK’s three
clearinghouses: The National Diabetes
Information Clearinghouse (NDIC); the
National Digestive Diseases Information
Clearinghouse (NDDIC); and the
National Kidney and Urologic Diseases
Information Clearinghouse (NKUDIC).
The survey responds to Executive Order
12821, ‘‘Setting Customer Service
Standards,’’ which requires agencies and
departments to identify and survey their
‘‘customers to determine the kind and
quality of service they want and their
level of satisfaction with existing
services.’’ Frequency of Response: On
occasion. Affected Public: Individuals or
households; business and for profit
organizations; not-for-profit agencies.
Type of Respondents: Physicians, health
care professionals, patients, family and
friends of patients.
The annual reporting burden is as
follows: Estimated number of
respondents: 7,079; estimated number of
responses per respondent: 1; estimated
average burden hours per response:
0.025; and estimated total annual
burden hours requested: 177. The
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[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34746-34748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14817]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0182]
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 July
19, 2010.
ADDRESSES: To ensure that comments on the information collection are
received,
[[Page 34747]]
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 e-mailed 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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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--(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 (Sec. 1240.60 (21 CFR 1240.60)) is a customary and usual
practice among seafood processors. Consequently, the estimates in table
1 account only for information collection and recording requirements
attributable to part 123. Respondents to this collection of information
include processors and importers of seafood.
In the Federal Register of April 9, 2010 (75 FR 18211), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section\2\ Recordkeepers Recordkeeping\3\ Records Record\4\ Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(a),(b), and (c) 50 1 50 16.00 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(c)(5) 15,000 4 60,000 0.30 18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.8(a)(1) and (c) 15,000 1 15,000 4.00 60,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(a)(2)(ii) 4,100 80 328,000 0.20 65,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(c)(7) 15,000 280 4,200,000 0.30 1,260,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.7(d) 6,000 4 24,000 0.10 2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.8(d) 15,000 47 705,000 0.10 70,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.11(c) 15,000 280 4,200,000 0.10 420,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(c) 4,100 80 328,000 0.10 32,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(a)(2) 41 1 41 4.00 164
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)).
[[Page 34748]]
\3\Based on an estimated 280 working days per year.
\4\Estimated average time per 8-hour workday unless one-time response.
FDA bases 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 (Sec. 1240.60) is a customary and usual practice among
seafood processors.
Based on its records, FDA estimates that there are 15,000
processors and 4,100 importers. FDA estimates that 50 processors will
undertake the initial preparation of a hazard analysis and HAACP plan
(Sec. 123.6(a),(b), and (c)). FDA estimates 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. FDA estimates that all
processors (15,000 processors) will undertake and keep records of 4
corrective action plans (Sec. 123.6(c)(5)) for a total of 60,000
records. FDA estimates the burden for the preparation of each record to
be 0.30 hours for a total burden of 18,000 hours.
FDA estimates that all processors (15,000 processors) will annually
reassess their hazard analysis and HACCP plan (Sec. 123.8(a)(1) and
(c)). FDA estimates 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.
FDA estimates 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. FDA estimates the burden for the preparation
of each record to be 0.20 hours for a total burden of 65,600 hours.
FDA estimates 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. FDA estimates
the burden for the preparation of each record to be 0.30 hours for a
total burden of 1,260,000 hours.
FDA estimates 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. FDA estimates the burden for
the preparation of each record to be 0.10 hours for a total burden of
2,400 hours.
FDA estimates 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.
FDA estimates the burden for the preparation of each record to be 0.10
hours for a total burden of 70,500 hours.
FDA estimates 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. FDA estimates the burden
for the preparation of each record to be 0.10 hours for a total burden
of 420,000 hours.
FDA estimates 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)). 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.
FDA estimates that 1 percent of all importers (41 importers) will
require new written verification procedures to verify compliance of
imports (Sec. 123.12(a)(2)). FDA estimates the burden for preparing
the new procedures to be 4 hours per importer for a total burden of 164
hours.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-14817 Filed 6-17-10; 8:45 am]
BILLING CODE 4160-01-S
