G/SPS/N/USA/3222  
 
6 January 2021  
(21-0223) 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:  Animal and Plant Health Inspection Service (APHIS)  
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):  Animals modified or developed by genetic engineering  
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:  Regulation of the Movement of Animals Modified or 
Developed by Genetic Engineering [Docket No. APHIS -2020-0079] . Language(s):  
English . Number of pages:  7 
https://beta.regulations.gov/document/APHIS -2020-0079-0001 
6. Description of content:  The United States Department of Agriculture (USDA) is 
soliciting public comment on establishing regulations for the movement of certain animals 
modified or developed by genetic engineering. Under the regulatory framework being 
contemplated, USDA would pro mulgate regulations using the authorities granted to the 
Department through the Animal Health Protection Act, the Federal Meat Inspection Act 
(FMIA), and the Poultry Products Inspection Act (PPIA). Pursuant to these authorities, the 
Animal and Plant Health  Inspection Service (APHIS) would conduct a safety assessment 
of animals subject to the FMIA or PPIA that have been modified or developed using genetic 
engineering that may increase the animal's susceptibility to pests or diseases of livestock, 
including z oonotic diseases, or ability to transmit the same. The Food Safety and 
Inspection Service (FSIS) would conduct a pre -slaughter food safety assessment to 
ensure that the slaughter and processing of certain animals modified or developed using 
genetic enginee ring would not result in a product that is adulterated or misbranded. 
(Federal Register Vol. 85, No. 248, Monday, 28 December 2020; pp. 84269 -84275)  
7. Objective and rationale: [X]  food safety, [X]  animal health, [  ] plant protection, 
[X] protect humans f rom 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) :  G/SPS/N/USA/3222  
 
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  [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:    
10. Proposed date of adoption (dd/mm/yy) : To be determined.  
Proposed date of publication (dd/mm/yy) : To be determined.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 26 February 2021  
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:   
Dr. Alan Pearson, Assistant Deputy Administrator, Biotechnology Regulatory Services; 
APHIS, 4700 River Road, Unit 98, Riverdale, MD 20737 -1238; +(301) 851 3944; 
Alan.Pearson@usda.gov  
Dr. Kis Robertson Hale, Deputy Assistant Administrator, Office of Public Health Science, 
USDA Food Safety and Inspection Service, 1400 Independence Avenue SW, Room 341 -
E. Whitten Building; +(202) 720 4819; Kis.Robertson1@usda.gov  
13. Text(s) available from: [  ] National Notifica tion Authority, [  ] National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
https://beta.regulations.gov/document/APHIS -2020-0079-0001