. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/703/Add.1 
15 December 2004 
 (04-5529) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
 
  
NOTIFICATION  
 
Addendum
 
 
  The following communication, dated 13 December 2004, is being circulated at the request of 
the Delegation of the United States
. 
 
_______________ 
 
 Final Rule:  Establishment and Maintenance of Records Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Docket No. 2002N-0277)  
 
 On 9 December 2004 the US Food and Drug Administration (FDA) published in the Federal 
Register  a final rule implementing Section 306 of th e Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Bioterr orism Act):  Establishm ent and Maintenance of 
Records (Docket No. 2002N-0277).  The final rule requires persons (excluding farms, restaurants, 
foreign persons, except foreign persons who transport food in the U.S., and certain others) who 
manufacture, process, pack, transport, distribute, rece ive, hold or import food in the U.S. to establish 
and maintain records.  The records that must be kept  by these regulations are those that are needed by 
the FDA for inspection to identify the immediate previous sources and immediate subsequent 
recipients of food, including its packaging, in or der to address credible threats of serious adverse 
health consequences or death to humans or animals.  The record retention period for human foods 
ranges from six months to two years depending on the shelf life of the food.  Records for animal food, including pet food, must be retained for one year .  The maximum record retention requirement for 
transporters of all types of food is one year.  Reco rds must be retained at the establishment where the 
activities covered in the records o ccurred or at a reasonably accessible location.  To minimize the 
burden on persons affected by the final rule, the required information may be kept in any format, 
paper or electronic.  All businesses covered by this rule must comply within 12 months from the date 
the rule is published (9 December 2004) in the Federal Register, except  small and very small 
businesses.  Small businesses (11-499 full-time equivalent employees (FTEs)) must comply within 18 
months from this date, and very small businesses (10 or fewer FTEs) have to comply within 24 
months from this date.  When FDA has a reasonable  belief that an article of food is adulterated and 
presents a threat of serious adverse health consequences or death to humans or animals, any records or 
other information to which FDA has access must be available for inspection and copying as soon as 
possible, not to exceed 24 hours from time of receipt of the official request.   Complete text of the Final Rule contained in the Federal Register (FR), 69 FR 71561-71655 
(available in English) can be found on the Internet at: 
 
http://www.fda.gov/OHRMS/D OCKETS/98fr/04-26929.htm
 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26929.pdf  
  
 G/SPS/N/USA/703/Add.1 
Page 2  
 
  Further information can be found on the FDA website at: 
 
http://www.cfsan.fda.gov/~dms/fsbtact.html
   
 
 For further information contact:  Nega Beru , Center for Food Safety and Applied Nutrition 
(HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD  20740, 
301-436-1400. 
 
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