G/SPS/N/USA/2508/Add.3  
 
21 September 2015  
(15-4850)  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/Food  Combinations for Activities (Outside the Farm 
Definition) Conducted in a Facility Co-Located on a Farm; Availability 
The Food and Drug Administration (FDA) is announcing the availability of a document entitled 
"Qualitative Risk Assessment of Risk of Activity/F ood 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 acti vity/food combinations that would be considered 
low risk when conducted in a food facility co-located on a farm. We conducted this RA to satisfy requirements of the FDA Food Safety Modernizat ion 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 56357. Text can also be found in the Federal Register 80 FR 56357, Docket No. FDA-2012-N-1258 or on 
the internet at: https://federalregister.gov/a/2015-21922 . 
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: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
For further information contact: Jenny Scott, Center for Food Safety and Applied Nutrition 
(HFS 300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD  20740, 
240-402-2166.  G/SPS/N/USA/2508/Add.3 
 
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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 56357,Docket No. FDA-2012-N-1258 or on 
the internet at: https://federalregister.gov/a/2015-21922 .  
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