[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59636-59638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20779]


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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 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 
(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 (HACCP) principles to the 
processing of fruit and vegetable juices.

DATES: Submit either electronic or written comments on the collection 
of information by October 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 
``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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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

[[Page 59637]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                      Number of       Total
          21 CFR Section              Number of      records per      annual    Average  burden 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(a) and 20.12(a)(3), (b),              1,560             1.1        1,716  60.................      102,960
 and (c)--Require written HACCP
 plan.
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 verification
 activities associated with the
 HACCP system.
120.11(b) and 120.12(a)(5) and              1,840               1        1,840  4..................        7,360
 (b)--Require records showing
 validation activities associated
 with the HACCP system.
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 juice
 importers have written
 procedures to ensure that the
 juice is processed in accordance
 with our regulations in part 120.
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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.


[[Page 59638]]

    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: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20779 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P