G/SPS/N/USA/2862  
 
24 May 2016  
(16-2806)  Page: 1/3  
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: United States Food and Drug Administration 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): ICS Code(s): 67. Food contact substances 
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: Breast Cancer Fund, Center for Environmental Health, 
Center for Food Safety, Center for Science In The Public Interest, Clean Water Action, 
Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources 
Defense Council; Filing of Food Additive Petition; Notice of Petition  Language(s): 
English  Number of pages: 3 
https://www.gpo.gov/fdsys/pkg/F R-2016-05-20/pdf /2016-11866.pdf  
http://members.wto.org/crnattachments/2016/SPS/USA/16_2023_00_e.pdf  
6. Description of content: The Food and Drug Administration has filed a petition, 
submitted by Breast Cancer Fund, Center for Environmental Health, Center for Food 
Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' 
Environment, Learning Disabilities Association of America, and Natural Resources 
Defense Council proposing that we amend an d/or revoke specified regulations to no 
longer provide for the food contact use of specified ortho-phthalates. 
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 st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
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?   G/SPS/N/USA/2862 
 
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  [ ] 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) : Not applicable 
Proposed date of publication (dd/mm/yy) : Not applicable 
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) : 19 July 2016 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
You may submit comments as follows: 
Electronic Submissions 
Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for 
submitting comments. Comments submitted electronically, including attachments, to 
http://www.regulations.gov  will be posted to the docket unchanged. Because your 
comment will be made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party may not wish to 
be posted, such as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on 
http://www.regulations.gov . 
If you want to submit a comment with confidential information that you do not wish to 
be made available to the public, submit the comment as a written/paper submission and 
in the manner detailed (see "Written/Paper Submissions" and "Instructions"). 
Written/ Paper Submissions 
Submit written/paper submissions as follows: 
Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
For written/paper comments submitted to the Division of Dockets Management, FDA will 
post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions".  
Instructions: All submissions received must include the Docket No. FDA-2016-F-1253 for 
"Breast Cancer Fund, Center for Environmenta l Health, Center for Food Safety, Center 
for Science In The Public Interest, Clean Wate r Action, Consumer Federation of America, 
Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning 
Disabilities Association of America, and Natural Resources Defense Council; Filing of 
Food Additive Petition". Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions", publicly viewable at 
http://www.regulations.gov  or at the Division of Dockets Management between 9 a.m. 
and 4 p.m., Monday through Friday. 
Confidential Submissions--To submit a comment with confidential information that you 
do not wish to be made publicly available, submit your comments only as a 
written/paper submission. You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL IN FORMATION". The Agency will review G/SPS/N/USA/2862 
 
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  this copy, including the claimed confidential information, in its consideration of 
comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be availa ble for public viewing and posted on 
http://www.regulations.gov . Submit both copies to the Di vision of Dockets Management. 
If you do not wish your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of your comments 
and you must identify this information as "confidential". Any information marked as 
"confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to 
public dockets, see 80 FR 56469, 18 September 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm . 
13. Text(s) available from: [X] National Notifi cation 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 Division (IRSD), Stop 1014, 
Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: 
us.spsenquirypoint@fas.usda.gov  
Text can also be found in the Federal Register, Vol. 81, No. 98, page 31877 or on the 
internet at: https://www.gpo.gov/fdsys/pkg/F R-2016-05-20/pdf/2016-11866.pdf