Notice2022-21862
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
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Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 information collection provisions of our regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing and importing of fruit and vegetable juices.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61087-61089]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21862]
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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, Agency, or we) 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 information collection
provisions of our regulations mandating the application of hazard
[[Page 61088]]
analysis and critical control point (HACCP) principles to the
processing and importing of fruit and vegetable juices.
DATES: Either electronic or written comments on the collection of
information must be submitted by December 6, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 6, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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
``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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#114143504265707777517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="1c4c4e5d4f687d7a7a5c7a787d3274746f327b736a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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
This information collection supports regulations in part 120 (21
CFR part 120) which 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
[[Page 61089]]
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 the
FD&C 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.
In an effort to reduce burden and assist respondents, our website
(<a href="https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp">https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp</a>) offers guidance for industry, training and education, and
background information to assist the food industry in developing and
implementing a Juice HACCP. Included in this information are guidance
documents entitled ``Juice HACCP and the FDA Food Safety and
Modernization Act'' (December 2021) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act</a>) and ``Juice HACCP
Hazards and Controls Guidance--First Edition'' (March 2004) (available
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first</a>). All Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115, which provide for public comment at any
time.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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120.6(c) and 120.12(a)(1) and 1,875 365 684,375 0.1 (6 minutes) 68,438
(b); require written
monitoring and correction
records for Sanitation
Standard Operating Procedures.
120.7; 120.10(a); and 2,300 1.1 2,530 20............. 50,600
120.12(a)(2), (b) and (c);
require written hazard
analysis of food hazards.
120.8(b)(7) and 120.12(a)(4)(i) 1,450 14,600 21,170,000 0.01 (1 minute) 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 (6 minutes) 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 (6 minutes) 9,568
120.12 (a)(5) 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 1,840 1 1,840 4.............. 7,360
120.12(a)(5) and (b); 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 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 a HACCP
plan because the original
hazard analysis did not reveal
hazards likely to occur).
120.14(a)(2), (c), and (d) and 308 1 308 4.............. 1,232
120.12(b); 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 1,560 1.1 1,716 60............. 102,960
120.12(a)(3), (b), and (c);
require written HACCP plan.
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Total...................... .............. .............. .............. ............... 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 for the next 3 years for the total
annual recordkeeping burden of our regulations in part 120. Based on
our experience with the information collection over the past 3 years,
our burden estimate remains unchanged since our last review of the
information collection.
Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21862 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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