[Federal Register: February 6, 2008 (Volume 73, Number 25)]
[Notices]
[Page 6973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe08-64]
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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