WORLD TRADE
ORGANIZATIONG/SPS/N/USA/691/Add.5
23 December 2003
(03-6731)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 19 December 2003, is being circulated at the request of
the Delegation of the United States.
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Compliance Policy Guide Sec.110.300 - Registration of Food Facilities Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
On 19 December 2003, the US Food and Drug Administration (FDA) announced the
availability of a compliance policy guide (CPG) S ec. 110.300 entitled "Registration of Food Facilities
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002".  The
CPG provides written guidance to FDA's staff on enforcement of section 305 of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the
agency's implementing regulation, which require, beginning on 12 December 2003, registration with
FDA for all domestic and foreign facilities that manufacture/process, pack, or hold food for human or
animal consumption in the United States.
This guidance is final upon the date of publication.  However, written or electronic
comments can be submitted at any time.  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 .
Submit comments by indicating Docket No. 2003D -0562.  The guidance document can be found at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0562-gdl0001.pdf
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0562-gdl0001.doc
The 19 December 2003, Federal Register notice 68 FR 70817-70818 can be found at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-31376.pdf
For further information contact:  Food for human consumption:  Judith Gushee, Division of
Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 301-436-2417.  Food for animal consum ption:  Isabel Pocurull, Division of Animal
Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and DrugAdministration, 301-827-0175.
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