[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6555-6556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02243]


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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 March 
6, 2020.

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 [email protected]. 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: 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, 
[email protected].

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 (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 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 the Federal Register of September 26, 2019 (84 FR 50852), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    We estimate the burden of this collection of information as 
follows:

 
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                                                  Number of
   21 CFR Section; activity       Number of      records per    Total annual     Average burden     Total hours
                                recordkeepers   recordkeeper       records     per 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                         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                           1,840              12          22,080    0.1 (6 minutes)           2,208
 120.12(a)(4)(ii) 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 (6 minutes)           9,568
 and 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.

[[Page 6556]]

 
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)              1,840               1           1,840                  4           7,360
 and (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)                308               1             308                  4           1,232
 and 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) and (b), and                   1,560             1.1           1,716                 60         102,960
 120.12(a)(3), (b), and (c);
 require written HACCP plan.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02243 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P