[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Notices]
[Page 62489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0384]


Draft Guidance for Industry: Standardized Training Curriculum for 
Application of HACCP Principles to Juice Processing; 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availability of a draft guidance document entitled ``Guidance for 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: Standardized Training Curriculum for Application of HACCP 
Principles to Juice Processing'' (the draft guidance). The draft 
guidance advises juice processors of FDA's view that the first edition 
of the ``Juice HACCP Training Curriculum'' of the Juice HACCP Alliance 
(the standardized curriculum) is adequate for use in training 
individuals to meet the requirements of the juice hazard analysis and 
critical control point (HACCP) regulation. The draft guidance also 
advises processors and educators on how the requirements of the juice 
HACCP regulation may be met using the standardized curriculum or 
alternative curricula for training individuals and on how they can 
view, download, or purchase the standardized curriculum.

DATES: Submit written or electronic comments concerning this draft 
guidance by December 6, 2002, to ensure adequate consideration in 
preparation of the final guidance document. Comments on this draft 
guidance may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Michael E. Kashtock, (see FOR FURTHER INFORMATION CONTACT). 
Send two self-addressed adhesive labels to assist that office in 
processing your request. Submit written comments on the draft guidance 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draft guidance.

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's juice HACCP regulation in part 120 (21 CFR part 120) includes 
in Sec. 120.13 a requirement that individuals who perform certain 
specified functions, e.g., developing the hazard analysis or the HACCP 
plan, ``shall have successfully completed training in the application 
of HACCP principles to juice processing at least equivalent to that 
received under standardized curriculum recognized as adequate by the 
Food and Drug Administration, or shall be otherwise qualified through 
job experience to perform these functions.'' This draft guidance 
advises juice processors of FDA's view that the first edition of the 
``Juice HACCP Training Curriculum'' of the Juice HACCP Alliance 
(coordinated through the efforts of the National Center for Food Safety 
and Technology at the Illinois Institute of Technology) (the 
standardized curriculum) is adequate for use in training individuals to 
meet the requirements of the juice HACCP regulation. This guidance also 
advises processors and educators on how the requirements of the juice 
HACCP regulation may be met using the standardized curriculum or 
alternative curricula for training individuals and on how they can 
view, download, or purchase the standardized curriculum.
    The draft guidance entitled ``Guidance for Industry: Standardized 
Training Curriculum for Application of HACCP Principles to Juice 
Processing,'' is being issued as a level 1 draft guidance consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). This 
draft guidance represents the agency's current thinking on curricula 
for training juice processing personnel in the application of HACCP 
principles to juice processing. 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.

II. 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 the brackets in the heading of this document. The draft 
guidance and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

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

    Dated: September 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25391 Filed 10-4-02; 8:45 am]
BILLING CODE 4160-01-S