. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1008 
9 December 2004 
 (04-5412) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
 
  
NOTIFICATION  
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved: 
2. Agency responsible:   Food and Drug Administration – FDA 
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Bottled Water, HS 2201 
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:   Quality Standard for 
Arsenic in Bottled Water, Proposed Rule  (10 pages, available in English) 
6. Description of content:  FDA has issued a proposed rule to amend its bottled water quality 
standard regulations by revising the existing al lowable level for the contaminant arsenic.  
As a consequence, bottled water manufacturers wo uld be required to monitor their finished 
bottled water products for arsenic at leas t once each year under the current food 
manufacturing practice (CGMP) regulati ons for bottled water.  Bottled water 
manufacturers would also be required to monitor their source water for arsenic as often as necessary, but at least once every year unless they meet the criteria for the source water 
monitoring exemptions under the CGMP regulatio ns.  This proposed rule will ensure that 
the minimum quality of bottled water, as affect ed by arsenic, remains comparable with the 
quality of public drinking water that meets the U.S. Environmental Protection Agency's 
(EPA's) standards. 
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[   ] protect humans from animal/plant pest or disease,  [   ]  protect territory from other 
damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plan t Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s) in which these are available:  Proposed Rule in 
Docket Number 2004N-0416, Qua lity Standard for Arsenic in Bottled Water (available in 
English)  (69 FR 70082, 2 December 2004).  It can be found at: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26531.pdf .   G/SPS/N/USA/1008 
Page 2  
 
 10. Proposed date of adoption:   This proposed rule has a 60 day comment period.  Based on 
the comments received, FDA intends to publis h a final rule with an effective date of 
January 2006. 
11. Proposed date of entry into force:   January 2006 
12. Final date for comments:  Submit written or electronic comments by 31 January 2005. 
Agency or authority designated to handle comments:  Food and Drug Administration  
[   ] National notification authority, [ X ] National enquiry point, or address, fax number 
and E-mail address (if available) of other body:   Submit written comments on the 
document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, U.S.A.  It is possible to submit 
electronic comments to:  http://www.fda.gov/d ockets/ecomments .  Submit comments by 
indicating DOCKET No. 2004N-0416 and TITLE Quality Standard for Arsenic in Bottled 
Water 
13. Texts available from:  [ X ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS Enquiry Point / Notification Point 
Julie Morin 
U.S. Department of Agriculture 
Stop 1027 
Washington, DC 20250 Tel:  (202) 720-4051 Fax:  (202) 690-0677 
E-mail:  Julie.morin@fas.usda.gov 
Complete text can also be found on the Internet at 
http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2004&mn=12&dy=2
 by 
looking under DOCKET No. 2004N-0416.  Comments in the Docket may be found at: 
http://www.fda.gov/ohrms/docke ts/dockets/dockets2004.htm  by looking under the 
DOCKET No 2004N-0416.