G/SPS/N/USA/2593  
 
30 October 2013  
(13-5998)  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: Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Food for Animals, Proposed Rule  
Language(s): English  Number of pages: 405 
http://www.gpo.gov/fdsys/pkg/FR- 2013-10-29/html/2013-25126.htm  
6. Description of content: The US Food and Drug Administration (FDA) is proposing 
regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for 
current good manufacturing practice in manuf acturing, processing, packing, and holding 
of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and ri sk-based preventive controls for food for 
animals. FDA is taking this action to provide greater assurance that animal food is safe 
and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system. 
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/2 013-25126.htm . 
7. Objective and rationale: [X] food safety, [X] animal health, [ ] plant protection, 
[X] protect humans from animal/plant pe st 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)  
 Codex Alimentarius Commission, "Principles for the Establishment and 
Application of Microbiological Criter ia for Foods, CAC/GL 21-1997", 1997 
 Codex Alimentarius Commission, "Hazard Analysis and Critical Control Point 
(HACCP) System and Guidelines For Its Application. Annex to CAC/RCP 1-1969 
(Rev. 4-2003)", 2003 
 Codex Alimentarius Commission, "Recomme nded International Code of Practice 
General Principles of Food Hygiene, CAC/RCP 1-1969 (Rev. 4-2003)", 2003 G/SPS/N/USA/2593 
 
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  [ ] 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: 
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; Availability. 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-2013-10-29/html/2013-
25124.htm . 
US Food, Drug, and Cosmetic Act, 
http://www.fda.gov/RegulatoryInformation/Le gislation/FederalFood DrugandCosmeticAct
FDCAct/default.htm  (available in English) 
10. Proposed date of adoption (dd/mm/yy) : Not applicable to proposed rule. 
Proposed date of publication (dd/mm/yy) : To be determined. 
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) : 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-2011-N-0922, 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: 
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. 2011-N-0922 for this rulemaking. 
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. 
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