WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2336 
8 March 2012  
 (12-1295) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES 
If applicable, name of local government involved:    
2. Agency responsible:  US Food and Drug Administration (FDA) 
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):  Infant feeding bottles and children's spil l-proof training cups (sippy cups)  
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:  Notice of petition-American Chemistry Council  
Language(s):  English  Number of pages:  3 
6. Description of content:  The Food and Drug Administration (FDA) is announcing that the 
American Chemistry Council (ACC) has filed a petition proposing that the food additive 
regulations be amended to no longer provide for the use of polycarbonate (PC) resins in 
infant feeding bottles and spill-proof cups desi gned to help train babies to drink from cups 
because these uses have been abandoned.  PC r esins are formed by the condensation of 4, 
4'-isopropylenediphenol (i.e., Bisphenol A (BPA)), and carbonyl chloride or diphenyl 
carbonate. 
The ACC petition contains public informati on and information collected from companies 
that produce PC resins to support the claim th at baby bottles and sippy cups containing PC 
resins are no longer being introduced into th e US market and that manufacturers of baby 
bottles and sippy cups have abandoned the use of PC resins in making these products.   
While section 409 of the FD&C Act and Sec.  171.130 also provide for amending or 
revoking a food additive regulation based on saf ety, an amendment or revocation based on 
abandonment is not based on safety, but is based on the fact that regulatory authorization is 
no longer necessary for the use of that food additive. 
The Agency is not requesting comments on th e safety of these uses of PC resins because 
such information is not relevant to abandonmen t, which is the basis of the proposed action. 
Any comments addressing the safety of PC resins or containing safety information on these resins will not be considered in FDA's evaluation of this petition. G/SPS/N/USA/2336 
Page 2  
 
  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:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 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:  Published on 
17 February 2012 in 77 Federal Re gister 9608 and can be found at 
http://www.gpo.gov/fdsys/pkg/FR-2012-02-17/html/2012-3744.htm  (available in English) 
10. Proposed date of adoption (dd/mm/yy) :  To be determined. 
Proposed date of publication (dd/mm/yy) :  To be determined. 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  To be determined. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Submit either electronic or written comments by 17 April 2012. 
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 submissions in the following ways: 
Fax:  301-827-6870 Mail/Hand delivery/Courier (for paper or CD-ROM submissions):  Division of Dockets 
Management (HFA-305), Food and Drug Admi nistration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD  20852 
Instructions:  All submissions received must include the Agency name and Docket No. 
FDA-2012-F-0031. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional 
information on submitting comments, see the "Comments" heading of the 
SUPPLEMENTARY INFORMATION section of this document. 
Docket:  For access to the docket to read background documents or comments received, go 
to http://www.regulations.gov  and insert the docket number(s), found in brackets in the 
heading of this document, into the "Search" box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fisher s Lane, rm. 1061, Roc kville, MD  20852.  G/SPS/N/USA/2336 
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  13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail add ress (if available) of other body:   V a n e e  
Komolprasert, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1217.