[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61087-61089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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, 240-402-7500.
     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 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.govinfo.gov/content/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, 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, 
[email protected].

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 
(https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp) 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act) and ``Juice HACCP 
Hazards and Controls Guidance--First Edition'' (March 2004) (available 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first). 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.
                                --------------------------------------------------------------------------------
    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


