[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69689-69690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27811]
[[Page 69689]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1427]
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 the information collection
provisions of our regulations mandating the application of hazard
analysis and critical control point (HAACP) principles to the
processing of fruit and vegetable juices.
DATES: Submit either electronic or written comments on the collection
of information by January 21, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to http://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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [email protected].
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 regulations in part 120 (21 CFR part 120) mandate the
application of HACCP principles to the processing of fruit and
vegetable juices. 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 under
section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a
food is adulterated if it is prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth or rendered
injurious to health. 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, territory or possession to
another, or from outside the United States into this country. Under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient enforcement of that act.
The rationale in establishing an HACCP system of preventive
controls is to design and check the process so that the final product
is not contaminated--not test for contamination after it may have taken
place. Under HACCP, processors of fruit and vegetable juices establish
and follow a preplanned sequence of operations and observations (the
HACCP plan) designed to avoid or eliminate one or more specific food
hazards, and thereby ensure that their products are safe, wholesome,
and not adulterated, in compliance with section 402 of the FD&C Act.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average
21 CFR Section Number of records per Total annual burden per Total hours
recordkeeper recordkeeper records recordkeeping
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120.6(c) and 120.12(a)(1) and 1,875 365 684,375 0.1 68,438
(b)--Require written monitoring
and correction records for
Sanitation Standard Operating
Procedures.....................
120.7 and 120.12(a)(2), (b) and 2,300 1.1 2,530 20 50,600
(c)--Require written hazard
analysis of food hazards.......
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120.8(b)(7) and 120.12(a)(4)(i) 1,450 14,600 21,170,000 0.01 211,700
and (b)--Require a
recordkeeping system that
documents monitoring of the
critical control points and
other measurements as
prescribed in the HACCP plan...
120.10(c) and 120.12(a)(4)(ii) 1,840 12 22,080 0.1 2,208
and (b)--Require that all
corrective actions taken in
response to a deviation from a
critical limit be documented...
120.11(a)(1)(iv) and (a)(2), and 1,840 52 95,680 0.1 9,568
120.12 (a)(5)--Require records
showing that process monitoring
instruments are properly
calibrated and that end-product
or in-process testing is
performed in accordance with
written procedures.............
120.11(b) and 120.12(a)(5) and 1,840 1 1,840 4 7,360
(b) -..........................
Require that every processor
record the validation that the
HACCP plan is adequate to
control food hazards that are
likely to occur................
120.14(a)(2), (c), and (d)-- 308 1 308 4 1,232
Require that importers of fruit
or vegetable juices, or their
products used as ingredients in
beverages, have written
procedures to ensure that the
food is processed in accordance
with our regulations in part
120............................
120.11(c) and 120.12(a)(5) and 1,840 1 1,840 4 7,360
(b)--Require documentation of
revalidation of the hazard
analysis upon any changes that
might affect the original
hazard analysis (applies when a
firm does not have an HACCP
plan because the original
hazard analysis did not reveal
hazards likely to occur.)......
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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 our estimate of the total annual recordkeeping
burden of our regulations in part 120. We base our estimate of the
average burden per recordkeeping on our experience with the application
of HACCP principles in food processing. We base our estimate of the
number of recordkeepers on our estimate of the total number of juice
manufacturing plants affected by the regulations (plants identified in
our official establishment inventory plus very small apple juice and
very small orange juice manufacturers). These estimates assume that
every processor will prepare sanitary standard operating procedures and
an 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 an HACCP plan under these regulations.
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27811 Filed 11-19-13; 8:45 am]
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