[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Pages 57962-57963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0357]


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 October 
25, 2010.

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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-796-3793.

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--(OMB Control 
Number 0910-0466)--Extension

    FDA's regulations in part 120 (21 CFR part 120) mandate the 
application of HACCP procedures to fruit and vegetable juice 
processing. HACCP is a preventative system of hazard control that can 
be used by all food processors to ensure the safety of their products 
to consumers. A HACCP system of preventive controls is the most 
effective and efficient way to ensure that these food products are 
safe. FDA's mandate to ensure the safety of the Nation's food supply is 
derived principally from the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 321, et seq.). Under the FD&C Act, FDA has 
authority to ensure that all foods in interstate commerce, or that have 
been shipped in interstate commerce, are not contaminated or otherwise 
adulterated, are produced and held under sanitary conditions, and are 
not misbranded or deceptively packaged; under section 701 (21 U.S.C. 
371), the FD&C Act authorizes the Agency to issue regulations for its 
efficient enforcement. 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

[[Page 57963]]

communicable diseases from one State to another State. 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. Through these 
regulations, FDA is implementing its authority under section 402(a)(4) 
of the FD&C Act (21 U.S.C. 342(a)(4)).
    In the Federal Register of July 14, 2010 (75 FR 40839), 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 Reporting Burden\1\
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                                                          No of         Annual Frequency per      Total Annual
                  21 CFR Section                      Recordkeepers         Recordkeeping           Records       Hours Per  Record      Total Hours
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120.6(c) and 120.12(a)(1) and (b)                               1,875                   365              684,375               0.1              68,437.5
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120.7; 120.10(a); and 120.12(a)(2), (b), and (c)                2,300                     1.1              2,530              20                50,600
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120.8(b)(7) and 120.12(a)(4)(i) and (b)                         1,450                14,600           21,170,000               0.01            211,700
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120.10(c) and 120.12(a)(4)(ii) and (b)                          1,840                    12               22,080               0.1               2,208
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120.11(a)(1)(iv) and (a)(2) and 120.12(a)(5)                    1,840                    52               95,680               0.1               9,568
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120.11(b) and 120.12(a)(5) and (b)                              1,840                     1                1,840               4                 7,360
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120.11(c) and 120.12(a)(5) and (b)                              1,840                     1                1,840               4                 7,360
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120.14(a)(2), (c), and (d)                                        308                     1                  308               4                 1,232
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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 of this document provides a breakdown of the total 
estimated annual recordkeeping burden. FDA bases this hour burden 
estimate on its experience with the application of HACCP principles in 
food processing.
    The burden estimates in table 1 of this document are based on an 
estimate of the total number of juice manufacturing plants (i.e., 
2,300) affected by the regulations. Included in this total are 850 
plants currently identified in FDA's official establishment inventory 
plus 1,220 very small apple juice manufacturers and 230 very small 
orange juice manufacturers. The total burden hours are derived by 
estimating the number of plants affected by each portion of the final 
rule and multiplying the corresponding number by the number of records 
required annually and the hours needed to complete the record. These 
numbers were obtained from the Agency's final regulatory impact 
analysis prepared for these regulations.
    Moreover, these estimates assume that every processor will prepare 
sanitary standard operating procedures and a 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 a HACCP plan 
under the regulations.

    Dated: September 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23824 Filed 9-22-10; 8:45 am]
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