WORLD TRADE
ORGANIZATIONG/SPS/N/USA/691/Add.1
31 July 2003
(03-4078)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 25 July 2003, has been received from the United States.
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Guidance on Necessity of the Use of Food Product Categories in Registration of Food Facilities
The US Food and Drug Administration (FDA) has issued a final guidance, "Necessity of the
Use of Food Product Categories in Registration of Food Facilities".  FDA has issued this guidance to
supplement its proposed rule, "Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002" ("the proposed rule").  FDA notified the
proposed rule to the Committee on Sanitary and Phytosanitary Measures on 3 February 2003.  Asstated in the notification, the effective date of the final rule is 12 December 2003.
FDA has developed this guidance in response to section 305(a) of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which states that
FDA may require registrants to submit the general food categories of food manufactured, processed,
packed, or held at the facility, if FDA determines "through guidance" that such information is
necessary.  This guidance contains FDA's finding that information about food categories is necessaryfor a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-
related emergency.
FDA is currently reviewing comments submitted in response to the proposed rule and
considering these comments in drafting its final rule, which is expected to publish by10 October 2003.  Because FDA has not yet issued the final rule, there is currently no requirement in
effect regarding registration with FDA under the Bioterrorism Act.  If the final rule includes food
product categories among its required elements, registrants will be required to submit these categories
as an element of their registrations by 12 December 2003.
The Federal Register Notice can be found at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/071703d.pdf  and the guidance can be found at
http://www.cfsan.fda.gov/guidance.html .  In addition, the notified document can be obtained from
Ms. Melissa S. Scales, HFS-24, Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, Tel. 301-436-2378, Fax 301-436-2637, e- mail:melissa.scales@cfsan.fda.gov .
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