. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2015 
4 May 2010  
 (10-2417) 
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:  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):  Modified whey 
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:  Fonterra (USA) Inc.;  Filing of Food Additive Petition 
Language:  English  Number of pages:  1   
6. Description of content:  FDA is announcing that Fonterra (USA) Inc. has filed a food 
additive petition proposing that the food a dditive regulations in 21 CFR part 173 be 
amended to permit the safe use of hydrogen per oxide in the manufacture of modified whey. 
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:    G/SPS/N/USA/2015 
Page 2  
 
  9. Other relevant documents and language (s) in which these are available:  The notice 
published in the Federal Register on 28 April 2010, 75 FR 22441 http://edocket.access.gpo.gov/2010/pdf/2010-9823.pdf
   
10. Proposed date of adoption (dd/mm/yy) :  To be determined. 
Proposed date of publication (dd/mm/yy) :  28 April 2010 
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) :  Comments will be accepted at anytime after publication of the notice 
of filing;  however, if a final rule is pr omulgated, it will address only those comments that 
were received prior to publication of the final rule. 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
Submit written or electronic comments identified by Docket No. FDA-2010-F-0200, by any 
of the following methods: 
− Federal eRulemaking Portal:  http://www.regulations.gov  Follow the instructions for 
submitting comments. 
Submit written submissions in the following ways: 
− 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, 
Docket No. FDA-2010-F-0200 for this rulemaking.   All objections received 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 a nd Standards Division (IRSD), Stop 1027, 
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  
for Docket No. FDA-2010-F-0200.  For access to  the docket to read background documents 
or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm  and insert the 
Docket No. FDA-2010-F-0200 into the "Search" box and follow the prompts.