[Federal Register: December 8, 2003 (Volume 68, Number 235)]
[Notices]
[Page 68400-68402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de03-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0525]
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 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 February 6, 2004.
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: Peggy Robbins, Office of Management
[[Page 68401]]
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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
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 (HAACP); Procedures for the
Safe and Sanitary Processing and Importing of Juice (OMB Control Number
0910-0466)--Extension
These regulations 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 21
U.S.C. 371, the act authorizes the agency to issue regulations for its
efficient enforcement. The agency also has authority under 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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Annual Frequency
21 CFR Section No. of per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Record
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120.6(c) and 1,875 365 684,375 0.1 68,438
120.12(a)(1)
and (b)
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120.7, 2,300 1.1 2,530 20 50,600
120.10(a), 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)(i
i) and (b)
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120.11(a)(1)(iv 1,840 52 95,680 0.1 9,568
),
120.11(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.
Table 1 provides a breakdown of the total estimated annual
recordkeeping burden. The estimates in this table have been reviewed by
the agency's HACCP experts, who have practical experience in observing
various processing operations and related recordkeeping activities.
The burden estimates in table 1 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
[[Page 68402]]
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: December 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30302 Filed 12-5-03; 8:45 am]
BILLING CODE 4160-01-S