
[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Proposed Rules]
[Page 18273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 123

[Docket No. FDA-2013-D-0269]


Draft Guidance for Industry on Purchasing Reef Fish Species 
Associated With the Hazard of Ciguatera Fish Poisoning; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 
Purchasing Reef Fish Species Associated With the Hazard of Ciguatera 
Fish Poisoning.'' The draft guidance, when finalized, will advise 
primary seafood processors who purchase reef fish how to minimize the 
risk of ciguatera fish poisoning (CFP) from fish that they distribute. 
The draft guidance is intended to help protect the public health by 
reducing the risk of CFP.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that FDA considers your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
May 28, 2013.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to 
Division of Seafood Safety/Office of Food Safety, Center for Food 
Safety and Applied Nutrition (HFS-325), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Karen Swajian, Division of Seafood 
Safety, Center for Food Safety and Applied Nutrition (HFS-325), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of the draft guidance entitled 
``Guidance for Industry: Purchasing Reef Fish Species Associated With 
the Hazard of Ciguatera Fish Poisoning.'' The draft guidance is 
intended for primary seafood processors who purchase reef fish such as 
grouper, amberjack, snapper, lionfish, king mackerel, and barracuda. 
The draft guidance recommends that primary seafood processors take 
measures to minimize the risk of CFP from fish that they distribute. 
This draft guidance is an update to and complements information from 
the guidance document entitled ``Fish and Fishery Products Hazards and 
Controls Guidance'' (the Guide) (Ref. 1), which helps the seafood 
processing industry develop seafood Hazard Analysis and Critical 
Control Point programs. The Guide identifies food safety hazards, 
including CFP, which are associated with fish and fishery products, and 
provides examples of recommended preventive measures to minimize the 
likelihood of the hazard's occurrence. Table 3-2 in the Guide provides 
a list of fish species currently associated with CFP. The draft 
guidance adds to the list of reef fish species associated with CFP.
    The draft guidance is being issued consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on this topic. 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.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site to find the most current 
version of the draft guidance.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address, but we are not responsible for any 
subsequent changes to Web sites after this document publishes in the 
Federal Register.)
    1. Food and Drug Administration, ``Fish and Fishery Products 
Hazards and Controls Guidance,'' April 28, 2011, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm.

    Dated: March 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06824 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P


