. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/79/Add.1 
11 January 2011  
 (11-0187) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum
 
  
The following communication, received on 7 January  2011, is being circulated at the request 
of the Delegation of the United States
. 
 
_______________ 
  
Food and Feed Additives;  Substances Generally Recognized as Safe;  Reopening of the Comment 
Period  
 The Food and Drug Administration (FDA) is reopening the comment period for the proposed 
rule published in the Federal Register of 17 Apr il 1997 (the 1997 proposed rule).  The 1997 proposed 
rule would replace the voluntary petition process to a ffirm the generally reco gnized as safe (GRAS) 
status of a substance intended for use in food fo r humans or animals with a voluntary notification 
procedure.  FDA is reopening the comment period to update comments.  The proposed rule would 
also clarify the criteria for exempting the use of a substance as GRAS. 
This addendum concerns a: 
[X] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[X] Modification of content and/or scope of previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:    
Comment period:  (If the addendum extends the scope of th e 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, th e comment period provided in the addendum may 
vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  28 March 2011 
Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[X] National Enquiry Point.  Address, fax number and e-mail address (if available) of other 
body: G/SPS/N/USA/79/Add.1 
Page 2  
 
  You may submit comments, including comments regard ing the proposed collection of information, 
identified by Docket No. FDA-1997-N-0020, 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, disk, or  CD-ROM submissions): Division of Dockets 
Management (HFA-305), Food and Drug Admini stration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852 
Instructions: All submissions received must in clude the Agency name and Docket No. FDA-1997-N-
0020, for this rulemaking. All comments rece ived may be posted without change to 
http://www.regulations.gov
, including any personal information provided. 
Docket: For access to the docke t 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. 
For further information contact :  
With regard to substances that would be used in human food: Paulette M. Gaynor, Center for Food 
Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-1192 
With regard to substances that would be used in food for animals: Geoffrey K. Wong, Center for 
Veterinary Medicine (HFV-224), Food and Drug Ad ministration, 7519 Standish Pl., Rockville, MD 
20855, 240-453-6879.  
Text available from:  [X] National Notification Au thority, [ ] National Enquiry Point.  Address, 
fax number and e-mail address (if available) of other body: 
United States SPS National Notification Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 27, Washington D.C. 20250;  Tel:  +(1 202) 720 
1301;  Fax:  +(1 202) 720 0433;  E-mail :  us.spsenquirypoint@fas.usda.gov  
Complete text can be also be found on the Internet : 
 http://www.gpo.gov/fdsys/pkg/FR -2010-12-28/pdf/2010-32344.pdf
 
 
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