WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2429 
24 July 2012  
 (12-4066) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES OF AMERICA 
If applicable, name of local government involved:    
2. Agency responsible:  US 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):  Infant formula packaging 
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:  Representative Edward J. Markey;  Filing of Food 
Additive Petition  Language(s):  English  Number of pages:  2 
 http://www.gpo.gov/fdsys/pkg/FR -2012-07-17/pdf/2012-17367.pdf   
6. Description of content:  The Food and Drug Administration (FDA) is announcing that 
Representative Edward J. Markey has filed a petition proposing that the food additive 
regulations be amended to no longer provi de for the use of Bisphenol A (BPA)-based 
epoxy resins as coatings in packaging for in fant formula because these uses have been 
abandoned.  BPA-based epoxy resins are formed by the reaction of 4,4'-isopropylenediphenol (i.e., BPA), and Epichlorohydrin.  
The petition submitted by Representative Markey contains public information and 
information collected from a survey of the US registered manufacturers of infant formula to 
support the petitioner''s claim that all US in fant formula manufacturers have abandoned the 
use of BPA-based epoxy resins as coatings in all food contact packaging for infant formula.  
According to the petition, these companies account ed for 100 per cent of the current infant 
formula market in the United States of America.  
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 the safety of these uses of BPA-based epoxy 
resins because such information is not releva nt to abandonment, 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 consid ered in FDA's evaluation of this petition. G/SPS/N/USA/2429 
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:      
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 September 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 electronic comments in the follo wing way: Federal eRulemaking Portal: 
http://www.regulations.gov . Follow the instructions for submitting comments. 
Submit written submissions in the followi ng ways:  Fax:  3 01-827-6870. Mail/Hand 
delivery/Courier (for paper or CD-ROM submi ssions):  Division of Dockets Management 
(HFA-305), Food and Drug Administration, 563 0 Fishers Lane, rm. 1061, Rockville, MD  
20852. 
Instructions:  All submissions received must include the Agency name and Docket No. 
FDA-2012-F-0728.  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/2429 
 Page 3 
 
 
  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 Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov