[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, 
PRAStaff@fda.hhs.gov.

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


