. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2156 
14 February 2011  
 (11-0749) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES
 
If applicable, name of local government involved:    
2. Agency responsible:  US Food and Drug Administration (FDA) 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Food for human and animal consumption, except for meat, poultry, and egg 
products that are exclusively regulated by the US Department of Agriculture (USDA).  The 
Act does not alter the jurisdiction between FDA and USDA. 
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:  Food Safety Modernization Act  Language(s):  English  
Number of pages:  89  
6. Description of content:  The United States President signed the Food Safety 
Modernization Act into law on 4 January 2011.  The intent of the law is to increase the 
safety of the US food supply.  Some of the key features of the new law are:  prevention 
(e.g., preventive controls for food facilities,  produce safety, intentional contamination); 
inspections and compliance (frequency of inspec tion, expanded records access, third party 
laboratory testing); enhanced enforcement t ools (e.g., recall, administrative detention, 
suspension of registration); enhanced partnerships (e.g., surveillance, inspection, food laboratories) and import safety (e.g., foreign supplier verification by importers, mandatory 
certification for high risk foods, accreditation of third party auditors). 
7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, 
[X] protect humans from animal/plant pest or  disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  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)    G/SPS/N/USA/2156 
Page 2  
 
  [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 Enrolled 
Bill version of the Public Law No. 111-353 can be found at: 
http://www.gpo.gov/fdsys/pkg/BILLS-111hr 2751enr/pdf/BILLS- 111hr2751enr.pdf . 
Once the law is officially published, an adde ndum containing an electronic link to the law 
will be sent to WTO. 
10. Proposed date of adoption (dd/mm/yy) :  The law was enacted on 4 January 2011. 
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) :  The Food Safety Modernization Act (P ublic Law No: 111-353) entered into 
force on 4 January 2011.  Subsequent regula tions will be develope d later to implement 
different aspects of the statute. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Not applicable 
This notice serves as information to the WTO Members. The United States will provide outreach to trad ing partners through various means in the 
coming months.  Your comments will help th e US Food and Drug Administration develop 
outreach efforts so that US trading partners  can gain a better understanding of the law.  
The United States will notify related proposed  implementing regulations as they are 
promulgated.  WTO Members will be able to submit comments to the dockets of the respective proposed rules at time of notification. 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  Please send comments, preferably electronically, to US Food 
and Drug Administration, Center for Food Sa fety and Applied Nutrition, by e-mail to 
FSMAWTO@fda.hhs.gov or by fax to +(1 301)  436-2618.Additional information can be 
found at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm239907.htm
 
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 Authority, USDA Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 20250;  Tel:  +(1 
202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov  
Text can be also be found on the Internet:  " http://www.gpo.gov/fdsys/pkg/BILLS-
111hr2751enr/pdf/BILLS-111hr2751enr.pdf "