
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13811-13812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1427]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
14, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0466. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of August 30, 2016 (81 FR 59636), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 13812]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                    Number of
                 21 CFR section                     Number of      records per    Total annual       Average burden per recordkeeping       Total hours
                                                  recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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(a) and 20.12(a)(3), (b), and (c)--Require           1,560             1.1            1716  60.....................................         102,960
 written HACCP plan.
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)--Require           1,840              12          22,080  0.1 (6 minutes)........................           2,208
 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 120.12 (a)(5)             1,840              52          95,680  0.1 (6 minutes)........................           9,568
 and (b)--Require records showing verification
 activities associated with the HACCP system.
120.11(b) and 120.12(a)(5) and (b)--Require               1,840               1           1,840  4......................................           7,360
 records showing validation activities
 associated with the HACCP system.
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 juice importers have written
 procedures to ensure that the juice is
 processed in accordance with our regulations
 in part 120.
                                                --------------------------------------------------------------------------------------------------------
    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 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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05105 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P


