[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Notices]
[Pages 40839-40840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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) 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 recordkeeping requirements for 
applying hazard analysis and critical control point (HAACP) procedures 
for safe and sanitary processing for processors of fruit and vegetable 
juice.

DATES: Submit either electronic or written comments on the collection 
of information by September 13, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 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 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 
act) (21 U.S.C. 321 et seq.). Under the 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 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 
communicable diseases from one State to another other 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 act (21 U.S.C. 342(a)(4)).
    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                 2,300                     1.1              2,530                 20                50,600
 (c)
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[[Page 40840]]

 
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 this 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 these regulations.

    Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17150 Filed 7-13-10; 8:45 am]
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