[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50852-50854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20937]
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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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 collection provisions of our
regulations mandating the application of hazard analysis and critical
control point (HACCP) principles to the processing of fruit and
vegetable juices.
DATES: Submit either electronic or written comments on the collection
of information by November 25, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 25, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-1427 for ``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.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
[[Page 50853]]
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to the processing of fruit and
vegetable juices. HACCP is a preventative 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.
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR Section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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120.6(c) and 120.12(a)(1) and (b); Require 1,875 365 684,375 0.1 (6 minutes)......................... 68,438
written monitoring and correction records for
Sanitation Standard Operating Procedures.
120.7; 120.10(a); and 120.12(a)(2), (b) and 2,300 1.1 2,530 20...................................... 50,600
(c); require written hazard analysis of food
hazards.
120.8(b)(7) and 120.12(a)(4)(i) and (b); 1,450 14,600 21,170,000 0.01 (1 minute)......................... 211,700
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) and (b); 1,840 12 22,080 0.1 (6 minutes)......................... 2,208
require that all corrective actions taken in
response to a deviation from a critical limit
be documented.
[[Page 50854]]
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) 1,840 52 95,680 0.1 (6 minutes)......................... 9,568
and (b); 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 (c); and 120.12(a)(5) and (b); 1,840 1 1,840 4....................................... 7,360
require that every processor record the
validation that the HACCP plan is adequate to
control food hazards that are likely to occur.
120.11(c) and 120.12(a)(5) and (b); require 1,840 1 1,840 4....................................... 7,360
documentation of revalidation of the hazard
analysis upon any changes that might affect
the original hazard analysis (applies when a
firm does not have a HACCP plan because the
original hazard analysis did not reveal
hazards likely to occur.
120.14(a)(2), (c), and (d) and 120.12(b); 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.
120.8(a), 120.8(b), and 120.12(a)(3), (b), and 1,560 1.1 1,716 60...................................... 102,960
(c); require written HACCP plan.
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Total..................................... .............. .............. 21,980,369 ........................................ 461,426
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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. Our estimate remains unchanged
since last review of the information collection. 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: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20937 Filed 9-25-19; 8:45 am]
BILLING CODE 4164-01-P