[Federal Register Volume 72, Number 107 (Tuesday, June 5, 2007)]
[Notices]
[Pages 31078-31079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10792]


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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: [email protected].

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