[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Notices]
[Page 62490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25341]



[[Page 62490]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0493]


Guidance for Industry: Exemptions From the Warning Label 
Requirement for Juice--Recommendations for Effectively Achieving a 5-
Log Pathogen Reduction; 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 entitled ``Exemptions from the Warning Label 
Requirement for Juice--Recommendations for Effectively Achieving a 5-
Log Pathogen Reduction.'' This guidance is intended to provide revised 
FDA guidance to small and very small fruit and vegetable juice 
processors for effectively achieving a 5-log pathogen reduction that is 
the basis for exempting juice products from the warning label 
requirement established by the final rule entitled ``Food Labeling: 
Warning and Notice Statement: Labeling of Juice Products'' (``the juice 
labeling rule''). A 5-log pathogen reduction is also a requirement of 
the final rule entitled ``Hazard Analysis and Critical Control Point 
(HACCP); Procedures for the Safe and Sanitary Processing and Importing 
of Juice'' (the ``juice HACCP rule'').

DATES: Submit written or electronic comments concerning the guidance at 
any time.

ADDRESSES: Submit written requests for single copies of this guidance 
entitled ``Guidance for Industry: Exemptions from the Warning Label 
Requirement for Juice--Recommendations for Effectively Achieving a 5-
Log Pathogen Reduction'' to Jennifer A. Burnham (see FOR FURTHER 
INFORMATION CONTACT).
    Submit written comments on the guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Jennifer A. Burnham, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
5100 Paint Branch Parkway, College Park, MD 20740, 301-436-2030, FAX: 
301-436-2632.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2001, FDA issued a draft guidance document that 
outlined the agency's current recommendations for effectively achieving 
a 5-log pathogen reduction in juice. The purpose of this draft guidance 
was to encourage processors who are not subject to the juice HACCP rule 
and who are performing a 5-log pathogen reduction to attain exemption 
from the warning label requirement to apply effective 5-log pathogen 
reduction treatments based upon FDA's most current scientific 
understanding. In the Federal Register notice of December 21, 2001 (66 
FR 65978), announcing the availability of the draft guidance document, 
FDA provided a 60-day period for comment on the draft guidance.
    FDA received four comments in response to the December 21, 2001, 
draft guidance document. These comments represented the views of trade 
associations representing small farm family citrus operations, 
commercial fresh citrus shippers, juice and juice beverage producers 
and suppliers, and a public health group. The comments suggested 
changes or modifications to FDA's revised recommendations for 
effectively achieving a 5-log pathogen reduction. FDA has considered 
the submitted comments and determined that the suggested changes or 
modifications are beyond the scope of this guidance or are not 
consistent with FDA's current scientific understanding of pathogen 
reduction. On its own initiative, FDA is making certain editorial 
changes in the guidance.

II. Conclusion

    The agency is adopting the revised recommendations for effectively 
achieving a 5-log pathogen reduction that is the basis for exempting 
juice products from the warning label requirement as presented in the 
draft guidance document. After considering the comments the agency 
received, the agency has determined that no changes are warranted.
    The guidance entitled ``Guidance for Industry: Exemptions from the 
Warning Label Requirement for Juice--Recommendations for Effectively 
Achieving a 5-Log Pathogen Reduction'' is being issued as a level 1 
guidance, consistent with FDA's good guidance practices regulation (21 
CFR 10.115). This guidance represents the agency's current 
recommendations for effectively achieving a 5-log pathogen reduction in 
juice. 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 
statutes and regulations.

III. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Dockets Management Branch (see ADDRESSES) on this 
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 guidance and received comments may be seen 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 document at 
http://www.cfsan.fda.gov/[tilde]dms/guidance.html.

    Dated: September 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25341 Filed 10-4-02; 8:45 am]
BILLING CODE 4160-01-S