G/SPS/GEN/1860  
 
18 November  2020 
(20-8281) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
INFORMATION TO MEMBERS : UNITED STATES – REQUIREMENT FOR ADDITIONAL 
TRACEABILITY RECORDS FOR CERTAIN FOODS  
SUBMISSION  BY THE UNITED STATES  OF AMERICA  
The following document , received on 13 November  2020, is being circulated at the request of the 
Delegation of the United Sta tes of America . 
 
_______________  
 
 
1.1.  On 23 September 2020, the United States Food and Drug Administration (FDA) published a 
proposed regulation to establish additional traceability record -keeping requirements for persons who 
manufacture, process, pack, or hold certain foods defined in the regulation. It was notified to the 
WTO with notification: G/SPS/N/USA/3203 . If finalized, the proposed rule, titled "Requirements for 
Additional Traceability Records for Certain Foods " would implement section 204(d) of the FDA Food 
Safety Modernization Act. It is also a key component of FDA's New Era of Smarter Food Safety 
blueprint.  
1.2.  Food traceability is the ability to follow the movement of a food product and its ingredients 
through all steps in the supply chain, both backward and forward. Traceability involves documenting 
and linking the production, processing, and distribution chain of food products and ingredients.  
1.3.  In the case of a foodborne illness outbreak  or contamination event, efficient product tracing 
helps the FDA and those who produce and sell food to rapidly find the source of the contaminated 
product and identify where contamination may have occurred. This enables faster removal of the 
affected prod ucts from the marketplace, reducing incidences of foodborne illnesses.  
1.4.  The proposed rule would require persons who manufacture, process, pack, or hold foods on 
the Food Traceability List (including foods that contain foods on the list as ingredients) to ke ep 
certain records describing their traceability operations and the listed foods they handle. 
This information can help FDA understand their traceability procedures and records when reviewing 
them during a foodborne illness outbreak or a routine inspection . 
1.5.  The record -keeping requirements in the proposed rule would only apply to foods on the Food 
Traceability List (including foods that contain foods on the list as ingredients).  
1.6.  FDA is accepting comments through 21 January 2021. After the comment period clos es, FDA 
will publish the final rule and Food Traceability List.  
1.7.  FDA will be holding a series of three public meetings to discuss the proposed rule. The public 
meetings are open to all interested parties. Additional information about these meetings and 
registrations is available on the FDA website.  
More information  
a. Documents  
• Federal Register Notice: https://ww w.federalregister.gov/documents/2020/09/23/2020 -
20100/requirements -for-additional -traceability -records -for-certain -foods ; G/SPS/GEN/1860  
 
- 2 - 
 
  • Proposed Food Traceability List: https://www.fda.gov/food/food -safety -modernization -act-
fsma/food -traceability -list. 
b. Links 
• Food traceability rule: https://www.fda.gov/food/food -safety-modernization -act-
fsma/fsma -proposed -rule-food-traceability ; 
• New Era of Smarter Food Safety: https://www.fda.gov/food/new -era-smarter -food-safety ; 
• Public meeting: Information on the  public meetings, including registration information, is 
available through FDA's website at: https://www.fda.gov/food/cfsan -constituent -
updates/fda -hold-public -meetings -discuss -requirements -additional -traceability -records -
certain -foods -proposed . 
__________