[Federal Register: October 7, 2002 (Volume 67, Number 194)]
[Notices]
[Page 62490]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc02-103]
[[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On December 21, 2001, FDA issued a draft guidance document that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