[Federal Register: May 14, 2007 (Volume 72, Number 92)]
[Notices]
[Page 27138-27140]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my07-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0165]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Hazard Analysis and Critical Control Point Procedures
for the Safe and Sanitary Processing and Importing of Juice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the
[[Page 27139]]
Paperwork Reduction Act of 1995 (the PRA), Federal agencies are
required to publish notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, and to allow 60 days for
public comment in response to the notice. This notice solicits comments
on recordkeeping requirements for applying hazard analysis and critical
control point (HAACP) procedures for safe and sanitary processing for
processors of fruit and vegetable juice.
DATES: Submit written or electronic comments on the collection of
information by July 13, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120
(OMB Control Number 0910-0466)--Extension
FDA's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to fruit and vegetable juice
processing. HACCP is a preventative system of hazard control that can
be used by all food processors to ensure the safety of their products
to consumers. A HACCP system of preventive controls is the most
effective and efficient way to ensure that these food products are
safe. FDA's mandate to ensure the safety of the Nation's food supply is
derived principally from the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 321, et seq.). Under the act, FDA has authority to
ensure that all foods in interstate commerce, or that have been shipped
in interstate commerce, are not contaminated or otherwise adulterated,
are produced and held under sanitary conditions, and are not misbranded
or deceptively packaged; under section 701 (21 U.S.C. 371), the act
authorizes the agency to issue regulations for its efficient
enforcement. The agency also has authority under section 361 of the
Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
communicable diseases from one State to another other State.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements are narrowly
tailored to focus on the development of appropriate controls and
document those aspects of processing that are critical to food safety.
Through these regulations, FDA is implementing its authority under
section 402(a)(4) of the act (21 U.S.C. 342(a)(4)).
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 Total Annual
21 CFR Sections Recordkeepers of Recordkeeping Records Hours per Record Total Hours
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120.6(c) and 1,875 365 684,375 0.1 68,437.5
120.12(a)(1) and
(b)
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120.7; 120.10(a) 2,300 1.1 2,530 20 50,600
and
120.12(a)(2),
(b), and (c)
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120.8(b)(7) and 1,450 14,600 21,170,000 0.01 211,700
120.12(a)(4)(i)
and (b)
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120.10(c) and 1,840 12 22,080 0.1 2,208
120.12(a)(4)(ii)
and (b)
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120.11(a)(1)(iv) 1,840 52 95,680 0.1 9,568
and (a)(2) and
120.12 (a)(5)
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120.11(b) and 1,840 1 1,840 4 7,360
120.12(a)(5) and
(b)
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120.11(c) and 1,840 1 1,840 4 7,360
120.12(a)(5) and
(b)
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120.14(a)(2), 308 1 308 4 1,232
(c), and (d)
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Total 358,466
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 27140]]
Table 1 of this document provides a breakdown of the total
estimated annual recordkeeping burden. FDA bases this hour burden
estimate on its experience with the application of HACCP principles in
food processing.
The burden estimates in table 1 of this document are based on an
estimate of the total number of juice manufacturing plants (i.e.,
2,300) affected by the regulations. Included in this total are 850
plants currently identified in FDA's official establishment inventory
plus 1,220 very small apple juice manufacturers and 230 very small
orange juice manufacturers. The total burden hours are derived by
estimating the number of plants affected by each portion of this final
rule and multiplying the corresponding number by the number of records
required annually and the hours needed to complete the record. These
numbers were obtained from the agency's final regulatory impact
analysis prepared for these regulations.
Moreover, these estimates assume that every processor will prepare
sanitary standard operating procedures and a HACCP plan and maintain
the associated monitoring records and that every importer will require
product safety specifications. In fact, there are likely to be some
small number of juice processors that, based upon their hazard
analysis, determine that they are not required to have a HACCP plan
under these regulations.
Dated: April 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9220 Filed 5-11-07; 8:45 am]
BILLING CODE 4160-01-S