[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34746-34748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14817]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by 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 [email protected]. 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\
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No. of Annual Frequency of Total Annual Hours per
21 CFR Section\2\ Recordkeepers Recordkeeping\3\ Records Record\4\ Total Hours
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123.6(a),(b), and (c) 50 1 50 16.00 800
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123.6(c)(5) 15,000 4 60,000 0.30 18,000
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123.8(a)(1) and (c) 15,000 1 15,000 4.00 60,000
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123.12(a)(2)(ii) 4,100 80 328,000 0.20 65,600
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123.6(c)(7) 15,000 280 4,200,000 0.30 1,260,000
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123.7(d) 6,000 4 24,000 0.10 2,400
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123.8(d) 15,000 47 705,000 0.10 70,500
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123.11(c) 15,000 280 4,200,000 0.10 420,000
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123.12(c) 4,100 80 328,000 0.10 32,800
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123.12(a)(2) 41 1 41 4.00 164
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Total 1,930,264
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\These estimates include the information collection requirements in the following sections: Sec. 123.16--Smoked Fish--process controls (see Sec.
123.6(b)); Sec. 123.28(a)--Source Controls--molluscan shellfish (see Sec. 123.6(b)); Sec. 123.28(c) and (d)--Records--molluscan shellfish (see
Sec. 123.6(c)(7)).
[[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]
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