G/SPS/N/USA/2827  
 
15 February 2016  
(16-0954)  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: US Food and Drug Administration (FDA) 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Sheep 
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: Import Tolerance  Language(s): English  Number of 
pages: 1 
http://www.fda.gov/downloads/AnimalVeterina ry/Products/ImportExports/UCM482764.p
df 
http://www.fda.gov/downloads/AnimalVeterina ry/Products/ImportExports/UCM482355.p
df 
6. Description of content: The following tolerances have been established for imported 
food containing residues of unapproved new animal drug monepantel. 
Drug: monepantel. Species: sheep. Tissue: 7 ppm monepantel sulfone in fat; 5 ppm 
monepantel sulfone in liver; 2 ppm monepant el sulfone in kidney; 0.7 ppm monepantel 
sulfone in muscle. 
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 st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
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:   G/SPS/N/USA/2827 
 
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  9. Other relevant documents and language (s) in which these are available:     
10. Proposed date of adoption (dd/mm/yy) : 19 January 2016 
Proposed date of publication (dd/mm/yy) : 19 January 2016 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 19 January 2016 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable 
Agency or authority designated to hand le comments: [X] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
For further information, please contac t Joanne Kla (Joanne.kla@fda.hhs.gov). 
13. Text(s) available from: [X] National Notifi cation Authority, [ ] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
United States SPS National Notification Auth ority, 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