[Federal Register: March 3, 2004 (Volume 69, Number 42)]
[Notices]
[Page 10051-10052]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr04-95]
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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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
mkashtoc@cfsan.fda.gov.
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announced the availability of a draft guidance document entitled
``Draft Guidance for Industry: Juice HACCP Hazards and Controls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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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