G/SPS/N/USA/2570  
 
30 July 2013  
(13-4103)  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 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): Human food under the jurisdiction of the US Food and 
Drug Administration which excludes meat, poultry and processed egg products. HS Codes: 03, 04, 05, 07, 08, 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: Accreditation of Third-Party Auditors/Certification 
Bodies to Conduct Food Safety Audits and to Issue Certifications, Proposed Rule  
Language(s): English  Number of pages: 59 
http://www.gpo.gov/fdsys/pkg/FR- 2013-07-29/pdf/ 2013-17994.pdf  
https://members.wto.org/crnattachments/2013/sps/USA/13_3029_00_e.pdf  
6. Description of content: The Food and Drug Administration (FDA) is amending its 
regulations to provide for the option of accreditation of third-party auditors/certification 
bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety 
Modernization Act (FSMA). Use of accredited th ird-party auditors/certification bodies and 
food and facility certifications would be voluntary and will help FDA prevent potentially harmful food from reaching US consumers and thereby improve the safety of the US food supply. FDA also expects that thes e regulations will increase efficiency by 
reducing the number of redundant food safety audits. Importers will not generally be 
required to obtain certifications, but in certain circumstances the FDA may use certifications from accredited auditors in determining whether to admit certain imported 
food into the United States that the FDA has determined poses a food safety risk or in 
determining whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food. 
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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) Principles for Food Import and Export Inspection and 
Certification (CAC/GL 20-1995) G/SPS/N/USA/2570 
 
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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: 
FDA Food Safety Modernization Act at " http://www.gpo.gov/f dsys/pkg/PLAW-
111publ353/pdf/PLAW-111publ353.pdf " (G/SPS/N/USA/2156) (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) : 26 November 2013 
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-2011-N-0146 and/or Regulatory Information Number (RIN) 0910-AG66, 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. FDA-2011-N-0146 and/or RIN 0910-AG66 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 bo x 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  
The text is available at: 78 FR 45782 and " http://www.gpo.gov/fds ys/pkg/FR-2013-07-
29/pdf/2013-17994.pdf "