[Federal Register: December 21, 2001 (Volume 66, Number 246)]
[Notices]
[Page 65978-65979]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de01-84]
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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Draft Guidance for Industry: Exemptions from the Warning Label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availability of a draft guidance document entitled ``Exemptions from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 This draft guidance describes FDA's current recommendations for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ADDRESSES: Submit written requests for single copies of the draft
guidance to Jennifer A. Burnham, Center for Food Safety and Applied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