
[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4347-4348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01462]


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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 
February 26, 2014.

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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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 regulations in part 120 (21 CFR part 120) mandate the 
application of HACCP principles to the processing of fruit and 
vegetable juices. HACCP is a preventive 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.
    The rationale in establishing an HACCP system of preventive 
controls is to design and check the process so that the final product 
is not contaminated--not test for contamination after it may have taken 
place. Under HACCP,

[[Page 4348]]

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 November 20, 2013 (78 FR 69689), 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:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                   Number of                     Average burden
        21 CFR section             Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and            1,875             365         684,375  0.1 (8 minutes).          68,438
 (b); Require written
 monitoring and correction
 records for Sanitation
 Standard Operating Procedures
 (SSOPs).
120.7 and 120.12(a)(2), (b)              2,300             1.1           2,530  20..............          50,600
 and (c); Require written
 hazard analysis of food
 hazards.
120.8(b)(7) and                          1,450          14,600      21,170,000  0.01 (1 minute).         211,700
 120.12(a)(4)(i) 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 (8 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),             1,840              52          95,680  0.1 (8 minutes).           9,568
 120.12(a)(5); 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 120.12(a)(5) and           1,840               1           1,840  4...............           7,360
 (b); Require that every
 processor record the
 validation that the HACCP
 plan is adequate to control
 food hazards that are likely
 to occur.
120.14(a)(2), (c), and (d);                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.
120.11(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 an HACCP plan because
 the original hazard analysis
 did not reveal hazards likely
 to occur).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         358,466
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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: January 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01462 Filed 1-24-14; 8:45 am]
BILLING CODE 4160-01-P


