. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2002 
21 April 2010  
 (10-2039) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES
 
If applicable, name of local government involved:    
2. Agency responsible:  Food and Drug Administration 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Bottled water (HS Code:  2201) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Beverages:  Bottled Water;  Reopening of the Comment 
Period  Language:  English  Number of pages:  3   
6. Description of content:  FDA is reopening the comment period for a 1993 proposed rule 
that proposed establishment of an allowable le vel in bottled water for the chemical di(2-
ethylhexyl)phthalate (DEHP).  FDA is seeki ng further comment on finalizing the allowable 
level for DEHP in the bottled water quality standard. 
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. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)  The World Health Organization (WHO) has established a guideline 
value for DEHP in drinking water of 0.008 mg/L.  The Codex Alimentarius 
General Standard for Bottled/Packaged Drinking Waters (Other than Natural 
Mineral Waters) requires that bottled/p ackaged drinking waters comply with 
WHO's guideline values. 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [X] Yes   [ ] No G/SPS/N/USA/2002 
Page 2  
 
   If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language (s) in which these are available:  See 75 FR 
16363 at http://edocket.access.gpo. gov/2010/pdf/2010-7292.pdf    
10. Proposed date of adoption (dd/mm/yy) :  Not determined. 
Proposed date of publication (dd/mm/yy) :  1 April 2010 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  Not applicable.  
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  1 June 2010 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
Submit written or electronic comments identified by [FDA- 1993–N–0259], by any of the 
following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov .  Follow the instructions 
for submitting comments. 
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 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 recei ved will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm
. 
13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
United States SPS National Notification Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Di vision (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.spsenquirypoint@fas.usda.gov  
Text can be found at http://edocket.access.gpo.go v/2010/pdf/2010-7292.pdf