[Federal Register Volume 73, Number 25 (Wednesday, February 6, 2008)]
[Notices]
[Page 6973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0079]


Guidance for Industry: Fish and Fisheries Products Hazards and 
Controls Guidance Third Edition June 2001: Letter to Seafood Processors 
that Purchase Grouper, Amberjack, and Related Predatory Reef Species 
Captured in the Northern Gulf of Mexico

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 ``Fish and Fisheries 
Products Hazards and Controls Guidance, Third Edition June 2001: Letter 
to Seafood Processors that Purchase Grouper, Amberjack and Related 
Predatory Reef Species Captured in the Northern Gulf of Mexico.'' The 
guidance sets forth the agency's recommendations for ensuring the 
safety of grouper, amberjack, and related predatory reef species 
captured in the northern Gulf of Mexico with respect to ciguatera fish 
poisoning (CFP). The guidance is in response to recent cases of CFP 
that have occurred in the United States.

DATES: This guidance is final February 6, 2008. Submit written or 
electronic comments on the guidance document at any time.

ADDRESSES: 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.regulations.gov. 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. Send one self-addressed adhesive label to assist the 
office in processing your request, or fax your request to 301-436-2651. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Byron Truglio, Center for Food Safety 
and Applied Nutrition (HFS-325), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1420.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Fish and Fisheries Products Hazards and Controls Guidance, Third 
Edition June 2001: Letter to Seafood Processors that Purchase Grouper, 
Amberjack and Related Predatory Reef Species Captured in the Northern 
Gulf of Mexico.'' The purpose of the document is to revise guidance 
provided to industry for processing potentially ciguatoxic fish species 
captured in the northern Gulf of Mexico which are subject to the 
provisions of the Hazard Analysis and Critical Control Point regulation 
for seafood (21 CFR part 123) (the seafood HACCP regulation). This 
guidance is in response to recent CFP outbreaks that have been traced 
to fish captured in an area in the United States where ciguatera was 
previously extremely rare. CFP is caused by consumption of fish that 
have eaten toxic marine algae directly or that have eaten other toxin-
contaminated fish. CFP can result in gastrointestinal, cardiovascular, 
and neurological symptoms. In severe cases, recurring neurological 
symptoms can persist for months to years.
    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 
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 CFP. The guidance represents the agency's current thinking on 
CFP from fish in the Northern Gulf of Mexico. 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. 
This guidance modifies our previous guidance on this subject (See 
``Fish and Fisheries Products Hazards and Controls Guidance, Third 
Edition June 2001'' http://www.cfsan.fda.gov/guidance.html). The 
recommendations in this guidance only pertain to grouper, amberjack, 
and related predatory reef species associated with CFP that have been 
captured in the Northern Gulf of Mexico. This guidance does not pertain 
to other species of fish that have not been associated with CFP.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance. 
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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.cfsan.fda.gov/guidance.html.

    Dated: January 31, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 08-537 Filed 2-1-08; 4:38 pm]
BILLING CODE 4160-01-S