 WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/32/Add.3 
23 December 2003 
 (03-6727) 
Committee on Technical Barriers to Trade Original:   English 
 
 
 
NOTIFICATION  
 
Addendum  
 
  The following communication from the United States 
is being circulated in accordance with 
Article 10.6. 
 
_______________  
 
 
Compliance Policy Guide Sec.110.300-- Registration of Food Facilities Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002  
 
On December 19, 2003, the U.S. Food and Drug Administration (FDA) announced the 
availability of a compliance policy guide (C PG) Sec. 110.300 entitled ``Registration of Food 
Facilities Under the Public Heal th Security and Bioterrorism  Preparedness and Response Act 
of 2002.'' The CPG provides writ ten guidance to FDA's staff on enforcement of section 305 
of the Public Health Security  and Bioterrorism Preparedne ss and Response Act of 2002 (the 
Bioterrorism Act) and the agency's implem enting regulation, whic h require, beginning on 
December 12, 2003, registration with FDA for al l domestic and foreign facilities that 
manufacture/process, pack, or hold food for hu man or animal consumption in the United 
States. 
 
This guidance is final upon the date of publicat ion. 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-
0554.   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 December 19, 2003, Federal Register not ice 68 FR 70817-70818 can be found at:   
http://www.fda.gov/OHRM S/DOCKETS/98fr/03-31376.pdf  
 FOR FURTHER INFORMATION C ONTACT:  Food for human consumption:   Judith 
Gushee, Division of Enforcement, Office of Co mpliance, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 301-4 36-2417.  Food for animal consumption:   
Isabel Pocurull, Division of Animal Feeds, Office of Surveillance and Compliance, Center 
for Veterinary Medicine, Food and Drug Administration, 301-827-0175. 
 
 
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