G/SPS/N/USA/2594/Add.1  
 
21 September 2015  
(15-4851)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 21 Septem ber 2015, is being circulated at the request 
of the Delegation of the United States of America. 
 
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 Qualitative Risk Assessment of Risk of Activity/A nimal Food Combinations for Activities (Outside 
the Farm Definition) Conducted in a Faci lity Co-Located on a Farm; Availability 
The Food and Drug Administration (FDA) is announcing the availability of a document entitled 
"Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located  on a Farm" (the RA). The purpose of the RA is 
to provide a science-based risk analysis of those activity/animal food combinations that would be 
considered low risk when conducted in an animal food facility co-located on a farm. FDA conducted 
this RA to satisfy requirements of the FDA Food  Safety Modernization Act (FSMA) to conduct a 
science-based risk analysis and to consider the results of that analysis in rulemaking that is 
required by FSMA. 
The notice published in the Federal Register on 17 September 2015, 80 FR 56359. Text can also be found in the Federal Register 80 FR 5635, Docket No. FDA-2013-N-1043 or on the 
internet at https://federalregister.gov/a/2015-21923 . 
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:   
Comment period: (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days. Under 
other circumstances, such as extension of or iginally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : Not applicable 
Agency or authority designated to handle co mments: [X] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
For further information contact: Mary J. Bartholo mew, Center for Veterinary Medicine (HFV-200), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6224.  G/SPS/N/USA/2594/Add.1 
 
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  Text(s) available from: [X] National Notificati on Authority, [ ] National Enquiry Point. 
Address, fax number and e-mail addre ss (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 
Text can also be found in the Federal Register 80 FR 5635, Docket No. FDA-2013-N-1043 or on the 
internet at https://federalregister.gov/a/2015-21923 . 
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