[Federal Register: June 5, 2007 (Volume 72, Number 107)]
[Notices]
[Page 31078-31079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn07-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0206]
Guidance for Industry: Refrigerated Carrot Juice and Other
Refrigerated Low-Acid Juices; 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 document entitled ``Guidance for Industry:
Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices.'' The
guidance sets forth the agency's recommendations for ensuring the
safety of refrigerated carrot juice and other low-acid refrigerated
juices. The guidance is in response to six recent cases of botulism
poisoning linked to refrigerated carrot juice that occurred in the
United States and Canada.
DATES: This guidance is final June 5, 2007. Submit written or
electronic comments on the guidance document at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Food Safety (HFS-317), Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-
2022, FAX: 301-436-2651. Send one self-addressed adhesive label to
assist the office in processing your requests. Submit written comments
on the guidance to the Division of Dockets Management (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, 301-436-2022, or e-
mail: michael.kashtock@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance document entitled
``Guidance for Industry: Refrigerated Carrot Juice and Other
Refrigerated Low-Acid Juices.'' The purpose of the document is to
provide guidance that will assist industry in processing and labeling
refrigerated carrot juice and other refrigerated low-acid juices, which
are subject to the pathogen reduction provisions of the Hazardous
Analysis and Critical Control Point regulation for juice (21 CFR part
120) (the juice HACCP regulation), in a manner intended to provide for
the safety of the juice when offered for sale by the processor and
during handling by the consumer after purchase. This guidance is in
response to six cases of botulism poisoning linked to refrigerated
carrot juice that occurred in the United States and Canada in September
and October 2006. Clostridium botulinum is a bacterium commonly found
in soil. Botulism is a rare but serious paralytic illness caused by
botulinum toxin, a nerve poison that under certain conditions is
produced by C. botulinum. Botulism can be fatal and is considered a
medical emergency. Foodborne botulism is not common in the United
States.
FDA is issuing this guidance as level 1 guidance consistent with
FDA's good guidance practices regulation (Sec. 10.115 (21 CFR
10.115)). Consistent with FDA's good guidance practices regulation, the
agency will accept comment, but is implementing the guidance document
[[Page 31079]]
immediately in accordance with Sec. 10.115(g)(2) because the agency
has determined that prior public participation is not feasible or
appropriate in light of the need to respond expeditiously to the recent
cases of botulism linked to refrigerated carrot juice. This guidance
represents the agency's current thinking on important practices for
ensuring the safety of refrigerated carrot juice and other low-acid
refrigerated juices subject to the juice HACCP regulation. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. You may use an alternative approach if such
approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact
the FDA staff responsible for implementing this guidance (see FOR
FURTHER INFORMATION CONTACT).
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this guidance
at any time. 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. The guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance
document at http://www.cfsan.fda.gov/guidance.html.
Dated: May 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10792 Filed 6-4-07; 8:45 am]
BILLING CODE 4160-01-S