[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Notices]
[Pages 10051-10052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-452]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0333]


Guidance for Industry: Juice Hazard Analysis Critical Control 
Point Hazards and Controls Guidance, First Edition; Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document related to the processing of juice 
entitled ``Guidance for Industry: Juice HACCP Hazards and Controls 
Guidance, First Edition.'' The guidance document supports and 
complements FDA's 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 guidance represents FDA's views on 
potential hazards in juice products and recommends how to control such 
hazards, and is designed to assist juice processors in the development 
of their HACCP plans.

DATES: You may submit written or electronic comments on the guidance 
document at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
Michael E. Kashtock, Center for Food Safety and Applied Nutrition (HFS-
305), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740. Send one self-addressed adhesive label to assist that 
office in processing your requests. Submit written comments on the 
guidance document to the Division of Dockets Management (HFA-305), 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 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, 301-436-2022, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 12, 2002 (67 FR 57829), FDA 
announced the availability of a draft guidance document entitled 
``Draft Guidance for Industry: Juice HACCP Hazards and Controls 
Guidance, First Edition.'' Under FDA's 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(a)(4)), if a processor 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 guidance is to help processors of juice products 
evaluate the likelihood that a food safety hazard may occur in their 
product, and to guide them in the preparation of appropriate HACCP 
plans for those

[[Page 10052]]

hazards that are reasonably likely to occur. Interested persons were 
given until November 12, 2002, to comment on the draft guidance.
    FDA received 11 written comments on the draft guidance document. 
The agency reviewed and evaluated these comments and has modified the 
guidance where appropriate.
    The guidance document is being issued as level 1 guidance, 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The guidance represents the agency's current thinking on the 
potential hazards that are associated with various juice products and 
processing operations, and how such hazards can be avoided using HACCP 
controls when the hazards 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 it satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this guidance 
document at any time. Two paper copies of any mailed comments are to be 
submitted, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The guidance and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Interested persons also may access the guidance document at http://www.cfsan.fda.gov/guidance.html.

    Dated: February 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E4-452 Filed 3-2-04; 8:45 am]
BILLING CODE 4160-01-S