G/SPS/N/USA/2862/A dd.2 
 
10 August 2016  
(16-4299) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
Addendum  
The following communication, received on 10 August 2016, is being circulated at the request of the 
Delegation of  the United States of America . 
 
_______________  
 
 
Breast Cancer Fund, Center for Environmental Health, Center for Food Saf ety, 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; Reopening of 
Comment Period  
The Food and Drug Administration (FDA) is reopening the comment period for the notice of filing 
that appeared in the Federal Register of 20 May 2016 (81 FR 31877). In the notice, FDA requested 
comments on a filed food additive petition (FAP 6B4815), submitted by the 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, Earthjusti ce, Environmental Defense Fund, 
Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources 
Defense Council, proposing that it amends and/or revoke specified regulations to no longer provide 
for the food contact use of specified ortho -phthalates. FDA is taking this action in response to a 
request for an extension to allow interested persons additional time to submit comments.  
The text is available in English at https://www.gpo.gov/fdsys/pkg/FR -2016-08-08/pdf/2016 -
18720.pdf . 
This addendum concerns a:  
[X] Modification of final date for comments  
[ ] Notification of adoption, publication or entry into force of regulation  
[ ] Modification of co ntent and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[ ] Other:   
Comment period: (If the addendum extends the scope of the pre viously notified 
measure in terms of products and/or potentially affected Members, a new deadline for 
receipt of comments should be provided, normally of at least 60 calendar days. Under 
other circumstances, such as extension of originally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : 19 September 2016  
Agency or authority designated to handle 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:  G/SPS/N/USA/2862/Add.2  
 
- 2 - 
 
  Electronic Submissions  
Submit electronic comments in the following way:  
Federal eRulemaking Porta l: 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 co mments, 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 Docke ts 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 informat ion 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 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 Counci l; 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 Divisi on 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 submiss ion. 
You s hould 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 
INFORMATION". The Agency will review 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 available for public viewing and posted on 
http://www .regulations.gov . Submit both copies to the Division 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 yo u must identify this 
information as "confide ntial". 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 do ckets, see 80 FR 56469, 18 September 2015,  or access the 
information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm . 
Text(s) available from: [X]  National Notif ication 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 (IRS D), 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. 152, page 52370 or on the internet at:  
https://www.gpo.gov/fdsys/pkg/FR -2016-08-08/pdf/2016 -18720.pdf .  
 
__________