WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2502 
10 January 2013  
 (13-0128) 
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 numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where applicable):  Human food under the jurisdiction of the US Food and Drug Administration.  
HS Code(s):  03, 04, 05, 07, 08, 09, 10, 11, 12, 15, 16, 17, 18, 19, 20, 21, 22;  ICS Code(s):  
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:  Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Cont rols for Human Food, Proposed Rule 
Language(s):  English  Number of pages:  680 
https://s3.amazonaws.com/public-inspec tion.federalregiste r.gov/2013-00125.pdf  
http://members.wto.org/crnattachments/2013/sps/USA/13_0144_00_e.pdf  
6. Description of content:  The Food and Drug Administration (FDA) is proposing to amend 
its regulation for Current Good Manufacturi ng Practice In Manufacturing, Packing, or 
Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and 
foreign facilities that are required to register  under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive 
controls for human food.  FDA also is propos ing to revise certain definitions in FDAs 
current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for farms.  FDA is taking this 
action as part of its announced initiative to revi sit the CGMPs since they were last revised 
in 1986 and to implement new statutory provisions  in the FD&C Act.  The proposed rule is 
intended to build a food safety system for the future that makes modern, science-, and risk-
based preventive controls the norm acro ss all sectors of the food system. 
The proposed rule would apply to both dom estic and foreign facilities.  However, as 
explained in the remainder of this docum ent, 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.    G/SPS/N/USA/2502 
Page 2  
 
  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) General Principles of Food Hygiene, CAC/RCP 1-1969 
[ ] 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-0920, by any of the 
following methods: 
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: Fax:  301 827 6870 Mail/Hand delivery/Courier (for paper or CD-ROM submissions):  Division of Dockets Management (HFA-305), Food and Drug Admi nistration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. 
All submissions received must include the Agency name and Docket No. FDA-2011-N-
0920 for this rulemaking.  All comments r eceived may be posted without change to 
http://www.regulations.gov , including any personal informa tion provided.  For additional 
information on submitting comments, see the Comments heading of the 
SUPPLEMENTARY INFORMATION section of this document.  G/SPS/N/USA/2502 
 Page 3 
 
 
  For access to the docket to read background documents or comments received, go to 
http://www.regulations.gov  and insert Docket No. FDA-2011-N-0920, 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  
Text available at:  " https://s3.amazonaws.com/public-ins pection.federalregister.gov/2013-
00125.pdf "