[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Notices]
[Page 35420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14897]



[[Page 35420]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0384]


Guidance for Industry: Standardized Training Curriculum for 
Application of Hazard Analysis Critical Control Point Principles to 
Juice Processing; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance document entitled ``Guidance for 
Industry: Standardized Training Curriculum for Application of HACCP 
Principles to Juice Processing'' (the guidance). The guidance advises 
juice processors of FDA's view that the 1st Edition of the Juice Hazard 
Analysis Critical Control Point (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 HACCP 
regulation. The 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: 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 
(CFSAN) (see FOR FURTHER INFORMATION CONTACT). Include a self-addressed 
adhesive label to assist that office in processing your request.
    Submit written comments on the document 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 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'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.'' The guidance advises juice 
processors of FDA's view that the 1st 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 guidance document is a level 1 guidance issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115) relating to 
the development, issuance, and use of guidance documents.
    In the Federal Register of October 7, 2002 (67 FR 62489), FDA 
announced the availability of a draft guidance document entitled 
``Guidance for Industry: Standardized Training Curriculum for 
Application of HACCP Principles to Juice Processing.'' The agency 
solicited public comment on the draft guidance document. FDA did not 
receive any comments and is finalizing the draft guidance document 
without revision.
    This 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.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding the guidance 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, 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. Received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    A copy of the guidance document is available on the Internet at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: June 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14897 Filed 6-12-03; 8:45 am]
BILLING CODE 4160-01-S