G/SPS/N/USA/2610  
 
13 January 2014  
(14-0107)  Page: 1/3  
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: 03, 04, 05, 09, 10, 11, 
12, 15, 16, 17, 18, 19, 20, 21, 22; ICS Codes: 65, 67 
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: Focused Mitigation Strategies To Protect Food Against 
Intentional Adulteration; Proposed Rule  Language(s): English  Number of pages: 49 
http://members.wto.org/crnattachments/2014/sps/USA/14_0097_00_e.pdf  
6. Description of content: The Food and Drug Administration is proposing to require 
domestic and foreign food facilities that are required to register under the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally 
introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant 
vulnerabilities identified at actionable process steps in a food operation. FDA is proposing 
these requirements as part of our implementa tion of the FDA Food Safety Modernization 
Act (FSMA). Further, as part of the proposal, FDA discusses an approach to addressing 
economically motivated intentional adulteration. We expect the proposed rule, if finalized 
as proposed, would help to protect food from intentional adulteration caused by acts of terrorism. 
This proposed rule would apply to both domestic and foreign facilities that are required 
to register under section 415 of the FD&C Ac t. However, as explained in the remainder 
of the document and shown in Diagram 1 an d Table 1 of the document, the proposed 
rule contains several exemptions. 
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 number of Codex 
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    G/SPS/N/USA/2610 
 
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  [ ] 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: 
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; Availability; Proposed Rule found at: http://www.gpo.gov/fds ys/pkg/FR-2013-12-
24/pdf/2013-30375.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:  
You may submit comments, identified  by Docket No. FDA-2013-N-1425 and/or 
Regulatory Information Number (RIN) 0910-AG63, by any of the following methods, 
except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of  Information and Regulatory Affairs, Office 
of Management and Budget (OMB) (see the ''Paperwork Reduction Act of 1995'' section 
of this document). 
Electronic submissions 
Submit electronic comments in the following way: 
Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for 
submitting comments. 
Written submissions 
Submit written submissions in the following ways: 
Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. 
Instructions: All submissions received must include the Agency name and Docket 
No. FDA-2013-N-1425 and Regulatory Information Number (RIN) 0910-AG63 for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov , including any personal information provided. For additional 
information on submitting comments, see the ''Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document. 
Docket: For access to the docket to read background documents or comments received, 
go to http://www.regulations.gov  and insert the docket number, found in brackets in the 
heading of this document, into the ''Search '' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. G/SPS/N/USA/2610 
 
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  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 available in the Federal Register, Vol. 78, No. 247, at page 78014 or at 
http://www.gpo.gov/fdsys/pkg/FR- 2013-12-24/pdf/ 2013-30373.pdf .