G/SPS/N/USA/2594
5 November 2013 
(13-6121)  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 Department of Health and Human Services, Food and Drug 
Administration 
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): Animal feed and pet food 
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: Draft Qualitative Risk Assessment of Risk of 
Activity/Animal Food Combinations for Activiti es (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm; Availability  Language(s): English  Number of 
pages: 10 
http://www.gpo.gov/fdsys/pkg/FR- 2013-10-29/html/2013-25124.htm  
6. Description of content: The US Food and Drug Administration (FDA) is announcing the 
availability of, and requesting comment on, a document entitled Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the 
Farm Definition) Conducted in a Facility Co-Located on a Farm (the draft RA). The 
purpose of the draft RA is to provide a science-based risk analysis of those 
activity/animal food combinations that would be considered low risk. 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 29 October 2013, 78FR 209. Text can be 
found at http://www.gpo.gov/fdsys/pkg/FR-201 3-10-29/html/2 013-25124.htm . 
7. Objective and rationale: [X] food safety, [X] 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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) Codex Alimentarius Commission, Codex Alimentarius 
Commission Procedural Manual, Twentieth Edition, 2011 
[ ] 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/2594 
 
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  [ ] None 
Does this proposed regulation conform to the relevant international standard?   
[X] 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: Current 
Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, Proposed Rule (available in English) 
10. Proposed date of adoption (dd/mm/yy) : Not applicable for Draft Qualitative Risk 
Assessment. 
Proposed date of publication (dd/mm/yy) : 29 October 2013 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : Not applicable for Draft Qualitative Risk Assessment. 
[ ] 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 2014 
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:  
You may submit comments, identified by Docket No. FDA-2013-N-1043, regarding the 
draft RA to http://www.regulations.gov  or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. 
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