G/SPS/N/USA/2502/Add.8  
 
27 September 2016  
(16-5146) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: Englis h 
 
  NOTIFICATION  
Addendum  
The following communication, received on 27 September 2016, is being circulated at the request 
of the Delegation of  the United States of America . 
 
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Current Good Manufacturing Practice, Hazard Analysis, and Risk -Based Preventive Controls for 
Human Food; Definition of Qualified Auditor; Announcement of Effective Date  
The Food and Drug Administration is announcing the effective date for the definition of qualified 
auditor in the two final rules that appeared in the Feder al Register of 17 September 2015.  
In the Federal Register of 17 September 2015 (80 FR 55908), FDA published a final rule for 
"Current Good Manufacturing Practices, Hazard Analysis, and Risk -Based Preventive Controls for 
Human Food" (preventive controls for  human food rule). In Section 117.3, FDA included the 
definition of a qualified auditor. In the definition, FDA provided examples of qualified auditors. 
Paragraph 2 of the definition reads "An audit agent of a certification body that is accredited in 
accor dance with regulations in part 1, subpart M of this chapter". At the time the final rule 
published, paragraph 2 referred to a provision in a future final rule: "Accreditation of Third -Party 
Certification Bodies to Conduct Food Safety Audits to Issue Certif ications" (third -party certification 
rule). The preamble to the preventive controls for human food rule stated that FDA would publish 
a document in the Federal Register announcing the effective date of paragraph (2) once FDA 
finalized the third -party certi fication rule (80 FR 55908 at 55954).  
The final third -party certification rule (80 FR 74569) published in the Federal Register on 
27 November 2015, with an effective date of 26 January 2016. This document announces that the 
effective date for paragraph 2 i n the definition of qualified auditor in Section 117.3 (80 FR 55098 
at 56147) is 19 September 2016.  
http://members.wto.org/crnattachments/2016/SPS/USA/16_4032_00_e.pdf  
This addendum concerns a:  
[ ] Modification of final date for comments  
[X] Notification of adoption, publication or entry into force of regulation  
[ ] Modification of content and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed r egulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[ ] Other:   
Comment period: (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potentially affected Members, a new  deadline for 
receipt of comments should be provided, normally of at least 60 calendar days. Under 
other circumstances, such as extension of originally announced final date for comments, 
the comment period provided in the addendum may vary.)  G/SPS/N/USA/2502/Add.8  
 
- 2 - 
 
  [ ] Sixty day s from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : Not Applicable. This is an announcement of an effective date.  
Agency or authority designated to handle comments: [ ]  National Notification Authority, 
[ ] National Enquir y Point. Address, fax number and e -mail address (if available) of 
other body:  
For further information contact: Jenny Scott, Center for Food Safety and Applied Nutrition 
(HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 207 40, Tel: 
+(1 240) 402 2166  
Text(s) 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 Foreign Agri cultural 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  
Text can also be found in the Federal Register, Vol. 81, No . 181, Page 64060 or on the Internet at: 
https://www.gpo.gov/fdsys/pkg/FR -2016-09-19/pdf/2016 -22494.pdf   
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