WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2503 
10 January 2013  
 (13-0129) 
Committee on Sanitary and Phytosanitary Measures  
  
 
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 numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where applicable):  Fruits and vegetables grown for human c onsumption, sprouts.  HS Code(s):  
07, 08, 0708;  ICS Code(s):  65, 67, 67.080, 65.020, 65.040, 65.060. 
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:  Standards for the Growing, Harvesting, Packing, and 
Holding of Produce for Human Consumption, Proposed Rule  Language(s):  English  
Number of pages:  547 
https://s3.amazonaws.com/public-inspec tion.federalregiste r.gov/2013-00123.pdf  
http://members.wto.org/crnattachments/2013/sps/USA/13_0145_00_e.pdf  
6. Description of content:  To minimize the risk of serious adverse health consequences or 
death from consumption of contaminated produce, the US Food and Drug Administration (FDA) is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce,  meaning fruits and vegetables grown for 
human consumption.  FDA is proposing these st andards as part of our implementation of 
the FDA Food Safety Modernization Act (FSM A).  These standards would not apply to 
produce that is rarely consumed raw, produ ce for personal or on-farm consumption, or 
produce that is not a raw agricultural comm odity. In addition, produce that receives 
commercial processing that adequately reduces the presence of microorganisms of public 
health significance would be eligible for exemp tion from the requirements of this rule.  The 
proposed rule would set forth procedures, pro cesses, and practices that minimize the risk of 
serious adverse health consequences or d eath, including those reasonably necessary to 
prevent the introduction of known or reasonably foreseeable biological hazards into or onto 
produce and to provide reasonable assurances th at the produce is not adulterated on account 
of such hazards.  We expect that the proposed  rule, if finalized as proposed, would reduce 
foodborne illness associated with the consumption of contaminated produce. 
The proposed rule would apply to both dom estic and imported produce.  However, as 
explained in the document, the proposed  rule contains several exemptions. G/SPS/N/USA/2503 
Page 2  
 
  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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) The Codex Code of Hygienic Practice for Fresh Fruits and 
Vegetables (CAC/RCP 53-2003)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] 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:      
10. Proposed date of adoption (dd/mm/yy) :  Not applicable to proposed rule. 
Proposed date of publication (dd/mm/yy) :  16 January 2013.  The US Federal Register 
will publish the proposed rule on 16 January 2013, a web link will be available at that time.  
An addendum to this notification will be sent at that time. 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  Not applicable to proposed rule. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  16 May 2013 
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:   
You may submit comments, identified by Docket No. FDA- 2011-N-0921, by any of the 
following methods. 
Submit electronic comments in the following way:  Federal eRulemaking Portal: 
http://www.regulations.gov .  Follow the instructions for submitting comments. 
Submit written submissions in the following ways:  Mail/Hand delivery/Courier (for paper 
or CD-ROM submissions):  Division of Do ckets 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- 2011-N-0921 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 s ubmitting comments, see the "Comments" heading of the 
SUPPLEMENTARY INFORMATION section of this document.  G/SPS/N/USA/2503 
 Page 3 
 
 
  Docket:  For access to the docket to read background documents or comments received, go 
to http://www.regulations.gov  and insert the docket number(s), FDA- 2011-N-0921, 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. 
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 1014, Washington D.C. 20250;  Tel:  +(1 
202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov  
https://s3.amazonaws.com/public-inspec tion.federalregiste r.gov/2013-00123.pdf