G/SPS/N/USA/2611  
 
13 January 2014  
(14-0108)  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): Multiple products - HS Codes: 04, 07, 08, 09, 10, 11, 
12, 15, 16, 17, 18, 19, 20, 21, 22 
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: Appendix 4 to Draft 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; Proposed Rule  Language(s): English
  
Number of pages: 3 
http://members.wto.org/crnattachments/2014/sps/USA/14_0098_00_e.pdf  
6. Description of content: On 16 January 2013, the Food and Drug Administration (FDA) 
announced the availability of, and requeste d comment on, a document entitled ''Draft 
Qualitative Risk Assessment of Risk of Activi ty/Food Combinations for Activities (Outside 
the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA). FDA 
is now announcing the availability of, and re questing comment on, a document entitled 
''Appendix 4 to Draft Qualitative Risk Assessm ent of Risk of Activity/Food Combinations 
for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a 
Farm'' (the draft RA Appendix). The purpose of the draft RA Appendix is to provide a 
science-based risk analysis of those foods whose production would be considered low risk with respect to the risk of intentional adulteration caused by acts of terrorism. The 
appendix supplements the science-based risk analysis already included in the draft RA, 
which does not consider the risk of intentional adulteration caused by acts of terrorism. FDA conducted this evaluation 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. 
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.   G/SPS/N/USA/2611 
 
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  8. Is there a relevant international st andard? 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)    
[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: 
The Draft Risk Assessment Appendix supple ments the science-based risk analysis 
already included in the Draft Risk Assessment found at: http://www.gpo.gov/fdsys/pkg/FR- 2013-01-16/pdf/ 2013-124.pdf , which does not 
consider the risk of intentional adulteration caused by acts of terrorism. 
The Draft Risk Assessment Appendix is associ ated with the Proposed Rule on Focused 
Mitigation Strategies to Protect Food Against Intentional Adulteration found at: 
http://www.gpo.gov/fdsys/pkg/FR- 2013-12-24/pdf/ 2013-30373.pdf  (available in 
English) 
10. Proposed date of adoption (dd/mm/yy) : Not applicable 
Proposed date of publication (dd/mm/yy) : Not applicable 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : Not applicable 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 31 March 2014 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
Submit electronic comments to http://www.regulations.gov . Submit written comments 
to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Identify Docket No. FDA-2013-N-1563 
when submitting comments. 
13. Texts available from: [X] National Notification 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  
Text is available in the Federal Register, Vol. 78, No. 247 at page 78064 or at: 
http://www.gpo.gov/fdsys/pkg/FR- 2013-12-24/pdf/ 2013-30375.pdf .