G/SPS/N/USA/3452  
7 May 2024  
(24-3623) Page: 1/2 
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:  Food and Drug Administration (FDA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Polymers of ethylene, in primary forms (HS code(s): 3901); Food 
technology (ICS code(s): 67)  
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:  Filing of Food Additive Petition From Environmental 
Defense Fund, Breast Cancer Prevention Partners, Center f or Food Safety, Environmental 
Working Group, Tom Neltner, and Maricel Maffini; Request To Amend the Food Additive 
Regulations To Remove Authorization of Fluorinated Polyethylene; Notification of Petition . 
Language(s):  English . Number of pages:  2 
https://www.federalregister.gov/d/2024 -09027  
https://members.wto.org/crnattachments/2024/SPS/USA/24_03119_00_e.pdf  
6. Description of content:  The Food and Drug Administra tion (FDA or we) is announcing 
that we have filed a food additive petition, submitted by Environmental Defense Fund, et 
al., proposing that the food additive regulations be amended to remove fluorinated 
polyethylene. The food additive petition was filed on  17 April 2024.  
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 standard ? 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 stand ard:  G/SPS/N/USA/3452  
 
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  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) : 25 June 2024  
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. Please note that late, untimely filed comments will 
not be considered. The https://www.regulations.gov  electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of 25 June 2024. Comments received 
by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if 
they are received on or before that date.  
Electronic Submissions  
Submit electronic  comments in the following way:  
• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for 
submitting comments. Comments submitted electronically, including attachments, to 
https://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 Soci al 
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 
poste d on https://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 wr itten/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): Dockets Management 
Staff (HFA –305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  
• For written/paper comments submitted to the Dockets Management Staff, 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 – 2024–F–1912 for 
"Filing of Food Additive Petition from Environmental Defense Fund, et al.; Request to  
Amend the Food Additive Regulations to Remove Fluorinated Polyethylene". Received 
comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as "Confidential Submissions", publicly viewable at 
https://www.regulations.gov  or at the Dockets Management Staff between 9 a.m. and 
4 p.m., Monday through Friday, +(240) 402 7500.  
13. Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Text can be found in the Federal Register, Vol. 89, No. 82, Page 32386 or on the internet 
at: https://www.federalregister.gov/d/2024 -09027 .