[Federal Register Volume 67, Number 177 (Thursday, September 12, 2002)]
[Notices]
[Page 57829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0333]


Draft Guidance for Industry: Juice HACCP Hazards and Controls 
Guidance, First Edition; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Guidance for 
Industry: Juice HACCP Hazards and Controls Guidance'' (first edition) 
(the draft guidance). The draft guidance supports and complements the 
FDA regulation that requires a processor of juice to evaluate its 
operations using Hazard Analysis Critical Control Point (HACCP) 
principles and, if necessary, to develop and implement HACCP systems 
for its operations. The draft guidance represents FDA's views on 
potential hazards in juice products and how to control them, and it is 
designed to assist juice processors in the development of HACCP plans.

DATES: Submit written or electronic comments concerning the draft 
guidance and collection of information by November 12, 2002, to ensure 
adequate consideration in the preparation of the final guidance 
document. Comments on the draft guidance may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Michael E. Kashtock, Center for Food Safety and Applied 
Nutrition (see FOR FURTHER INFORMATION CONTACT). Send two self-
addressed adhesive labels to assist that office in processing your 
request. Submit written comments concerning the draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets.ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2022, FAX 
301-436-2651, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the first edition of the 
draft guidance entitled ``Guidance for Industry: Juice HACCP Hazards 
and Controls Guidance.''
    Under the HACCP regulations in part 120 (21 CFR part 120), juice 
processors are required to evaluate their operations using HACCP 
principles and, if necessary, to develop and implement HACCP systems 
for their operations. Under Sec.  120.9, juice products are adulterated 
under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342) if a processor or importer fails to have and implement a 
HACCP plan when one is necessary, or otherwise fails to meet any of the 
requirements of the regulations. The primary purpose of the draft 
guidance is: (1) To help processors and importers of juice products 
identify the likelihood that a food safety hazard may occur in their 
product, and (2) to guide them in the preparation of appropriate HACCP 
plans for those hazards that are reasonably likely to occur.

II. Significance of the Guidance

    The draft guidance is a level 1 guidance issued consistent with 
FDA's good guidance practices regulations (21 CFR 10.115). The draft 
guidance represents the agency's current thinking on the potential 
hazards that are associated with various juice products and processing 
operations, and how the occurrence of these hazards can be avoided with 
HACCP controls when they are reasonably likely to occur, as required 
under part 120. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.
    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in the draft guidance has been submitted to 
OMB for review and was approved under OMB control number 0910-0466.

III. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m. Monday through 
Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.cfsan.fda.gov/[tilde]dms/guidance.html.

    Dated: August 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-23106 Filed 9-11-02; 8:45 am]
BILLING CODE 4160-01-S