. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1869 
22 September 2008  
 (08-4441) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
NOTIFICATION 
 
1. Member to Agreement notifying:  UNITED STATES
  
If applicable, name of local government involved:     
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  HS Code 2201 Bottled water 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  Trading 
partners 
5. Title, language and number of pages of the notified document:  Beverages;  Bottled Water 
(Proposed rule) (available  in English, 19 pages) 
6. Description of content:  The proposed rule would amend the US FDA’s bottled water 
regulations to ensure that bottled water is free  from fecal contamination, as indicated by the 
fecal indicator E. coli .  Under the revised regulatio ns, source wa ter containing E. coli  would 
not be considered to be of a safe, sanitary  quality and would be prohibited from use in the 
production of bottled water.  Finish ed bottled water products containing E. coli  would be 
considered adulterated.  
7. Objective and rationale:  [ X ] food safety, [   ] animal health,  [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease,  [   ] protect territory from other damage from pests    
8. International standard, guideline or recommendation:  
[ X ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
Relevant international standards are the Code x Alimentarius Standard for Natural Mineral 
Waters, CODEX STAN 108 - 1981, Rev. 1 – 1997 , and the Codex Alim entarius Code of 
Hygienic Practice for Bottled/Packaged Drinking Waters (other than Natural Mineral Waters) 
CAC/RCP 48-2001 . The proposed regulation is consiste nt with both Codex standards with 
respect to zero tolerance for E. coli.  G/SPS/N/USA/1869 
Page 2  
 
  9. Relevant documents and langu age(s) in which these are available:    
Federal Register, 17 Septembe r 2008, Vol. 73, pp. 53775-53793, 
http://www.fda.gov/OHRMS/DOC KETS/98fr/E8-21619.htm
 
10. Proposed date of adoption:  1 June 2009   
11. Proposed date of entry into force:  1 December 2009   
12. Final date for comments:  17 November 2008 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body: 
Submit written or electronic comments id entified by [FDA-2008-N-0446], by any of the 
following methods: 
• Federal eRulemaking Portal: http://www.regulations.gov  Follow the instructions for 
submitting comments. 
• Mail/Hand delivery/C ourier [For paper, disk, or CD-R OM submissions]: Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. 
Instructions: All submissions received must include the agency name and docket number for 
this rulemaking. All objections receiv ed will be posted without change to 
http://www.fda.gov/ohrms /dockets/default.htm . 
13. Texts available from:  [ X ] National notificati on authority, [   ] Na tional enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS National Notification Aut hority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division, Stop 1014, Washington D.C. 20250;  Tel: 
+(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.spsenquirypoint@fas.usda.gov.  
 Complete text can be also be found on the Internet at 
http://www.accessdata.fda.gov/ scripts/oc/ohrms/index.cfm  and insert Docket No. [FDA-
2008-N-0446].  For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrm s/dockets/default.htm
 and insert the Docket No. 
[FDA-2008-N-0446] into the "Search'' box and follow the prompts.