[Federal Register: December 8, 2003 (Volume 68, Number 235)]
[Page 68400-68402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0525]

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.


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 

DATES: Submit written or electronic comments on the collection of 
information by February 6, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management

[[Page 68401]]

Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 
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 (HAACP); Procedures for the 
Safe and Sanitary Processing and Importing of Juice (OMB Control Number 

    These regulations 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 21 
U.S.C. 371, the act authorizes the agency to issue regulations for its 
efficient enforcement. The agency also has authority under 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 

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
                                     Annual Frequency
 21 CFR Section        No. of               per        Total Annual     Hours per            Total Hours
                    Recordkeepers      Recordkeeping      Records        Record
120.6(c) and     1,875                     365         684,375             0.1       68,438
 and (b)
120.7,           2,300                       1.1       2,530              20         50,600
 120.10(a), and
 (b), and (c)
120.8(b)(7) and  1,450                  14,600         21,170,000          0.01      211,700
 ) and (b)
120.10(c) and    1,840                      12         22,080              0.1       2,208
 i) and (b)
120.11(a)(1)(iv  1,840                      52         95,680              0.1       9,568
120.11(b) and    1,840                       1         1,840               4         7,360
 and (b)
120.11(c) and    1,840                       1         1,840               4         7,360
 and (b)
120.14(a)(2),    308                         1         308                 4         1,232
 (c), and (d)
Total            ..................  ................  ............  ..............  358,466
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 provides a breakdown of the total estimated annual 
recordkeeping burden. The estimates in this table have been reviewed by 
the agency's HACCP experts, who have practical experience in observing 
various processing operations and related recordkeeping activities.
    The burden estimates in table 1 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

[[Page 68402]]

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: December 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30302 Filed 12-5-03; 8:45 am]