[Federal Register Volume 66, Number 246 (Friday, December 21, 2001)]
[Notices]
[Pages 65978-65979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0493]


Draft Guidance for Industry: Exemptions from the Warning Label 
Requirement for Juice--Recommendations for Effectively Achieving a 5-
Log 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availability of a draft guidance document entitled ``Exemptions from 
the Warning Label Requirement for Juice--Recommendations for 
Effectively Achieving a 5-Log Reduction.'' This draft document is 
intended to provide guidance to fruit and vegetable juice producers 
about FDA's revised recommendations for effectively achieving a 5-log 
pathogen reduction that is the basis for exempting juice products from 
the warning label requirement established by a July 8, 1998, final rule 
entitled ``Food Labeling: Warning and Notice Statement; Labeling of 
Juice Products'' (the juice labeling rule). A 5-log reduction is also a 
requirement of the January 19, 2001, 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). This draft guidance describes FDA's current recommendations for 
effectively achieving a 5-log pathogen reduction in juice.

DATES: Submit written or electronic comments to ensure adequate 
consideration in preparation of the final guidance document by February 
19, 2002. Comments on this guidance may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Jennifer A. Burnham, Center for Food Safety and Applied 
Nutrition (CFSAN) (address below).
    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.

FOR FURTHER INFORMATION CONTACT: Jennifer A. Burnham, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-260-0773, FAX: 202-205-4422.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has revised its guidance for effectively achieving a 5-log 
pathogen reduction in juice. The purpose of this guidance is to 
encourage those juice processors not yet subject to the juice HACCP 
rule (e.g., small and very small processors who are not subject to the 
juice HACCP rule until January 21, 2003 and January 20, 2004, 
respectively) who are performing a 5-log reduction to attain exemption 
from the warning label requirement to apply effective 5-log reduction 
treatments based upon current science. This draft guidance also 
provides guidance to processors at retail who are not subject to the 
juice HACCP rule and who are performing a 5-log reduction to attain 
exemption from the warning label requirements.
    In the Federal Register of July 8, 1998, FDA issued the juice 
labeling rule (63 FR 37030). That final rule requires a warning 
statement on fruit and vegetable juices and juice ingredients that have 
not been processed to prevent, reduce, or eliminate pathogenic 
microorganisms that may be present. Specifically, under 21 CFR 
101.17(g), juice and juice ingredients must bear a warning label if 
they have not been processed to achieve a 5-log pathogen reduction, or 
a reduction that is equal to, or greater than, the criterion 
established for process controls by any final regulation requiring the 
application of HACCP principles to the processing of juice and juice 
ingredients. The warning label was intended to provide a measure of 
public safety until final HACCP regulations could be established and 
implemented.
    In the Federal Register of January 19, 2001 (66 FR 6138), FDA 
issued the juice HACCP rule; this rule mandates the implementation of 
HACCP principles and an effective 5-log pathogen reduction treatment to 
ensure the safe and sanitary processing of fruit and vegetable juices 
and ingredients. In the juice HACCP rule, FDA set forth certain 
criteria for achieving the 5-log pathogen reduction, which are 
consistent with current scientific knowledge as described in the juice 
HACCP rule. This draft guidance will assist juice processors in 
effectively achieving a 5-log pathogen reduction in a manner consistent 
with that knowledge.
    This document is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The draft guidance entitled 
``Guidance for Industry: Exemptions from the Warning Label Requirement 
for Juice--Recommendations for Effectively Achieving a 5-Log 
Reduction'' is being issued as a level 1 draft guidance consistent with 
GGPs. This draft 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 
statute and regulations.

II. Comments

    Interested persons may submit written or electronic comments to the 
Dockets Management Branch (address above) on the draft guidance by 
February 19, 2002. However, interested persons may submit written or 
electronic comments at any time. 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

[[Page 65979]]

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 home page at http://www.cfsan.fda.gov.

    Dated: December 14, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-31453 Filed 12-20-01; 8:45 am]
BILLING CODE 4160-01-S