G/SPS/N/USA/3203  
 
25 September 2020  
(20-6528) 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:  US 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):  HS Code(s): 1211, 2008, 07, 0406, 0407, 08, 0302, 0303, 0306, 
0304, 0305, 0307; 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:  Requirements for Additional Traceability Records for 
Certain Foods; Proposed Rule . Language(s):  English . Number of pages:  55 
https://www.govinfo.gov/content/pkg/FR -2020-09-23/pdf/2020 -20100.pdf  
https://members.wto.org/crnattachments/2020/SPS/USA/20_5730_00_e.pdf  
6. Description of content:  The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to establish additional traceability recordkeeping requirements for persons that 
manufacture, process, pack, or hold foods the Agency has designated for inclusion on the 
Food Traceability List.  
The proposed rule would require these entities to estab lish and maintain records 
containing information on critical tracking events in the supply chain for these designated 
foods, such as growing, shipping, receiving, creating, and transforming the foods.  
The proposed requirements are intended to help the Agen cy rapidly and effectively 
identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address 
credible threats of serious adverse health consequences or death resulting from foods 
being adulterated or misbranded. We are issuing thi s proposed rule in accordance with 
the FDA Food Safety Modernization Act (FSMA).  
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.   G/SPS/N/USA/3203  
 
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  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 standard:   
9. Other relevant documents and language(s) in which these are available:  Food 
Traceability List: https://www.fda.gov/food/food -safety -modernization -act-fsma/food -
traceability -list (available in English)  
10. Proposed date of adoption (dd/mm/yy) :  
Proposed date of publication (dd/mm/yy) :  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) :  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty da ys from the date of circulation of the 
notification and/or (dd/mm/yy) : 21 January 2021 - Submit either electronic or 
written comments on the proposed rule by 21 January 2021. 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 
21 January 2021. Comments received by mail/hand delivery/courier (for written/paper 
submissions) wil l be considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.  
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:   
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 Social Security number, or 
confidential business informa tion, 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 
https://www.regulations.gov . 
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 th e 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 -2014-N-0053 for 
''Requirements for Additional Traceability Records for Certain Foods.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket G/SPS/N/USA/3203  
 
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  and, except for those submitted as ''Confidential Sub missions,'' publicly viewable at 
https://www.regulations.gov  or at the Dockets Management Staff between 9 a.m. and 4 
p.m., Monday through Friday.  
Docket: For access to the docket to read background do cuments or the electronic and 
written/paper comments received, go to https://www.regulations.gov  and insert the 
docket number, found in brackets in the heading of this document, into the ''Search'' bo x 
and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.  
FOR FURTHER INFORMATION CONTACT: Regarding the proposed rule: Brian Pendleton, 
Office of Policy, Food and Drug Administration, 10903 New H ampshire Ave., Silver Spring, 
MD 20993 -0002, 301 -796-4614, Brian.Pendleton@fda.hhs.gov.   
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. 85, No. 185, page 59984 or on the internet 
at https://www.govinfo.gov/content/pkg/FR -2020-09-23/pdf/2020 -20100. pdf 
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