G/SPS/N/USA/3045/Add.2  
8 January 2020  
(20-0083) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 6 January 2020, is being circulated at the request of the 
Delegation of  the United States of America . 
 
_______________  
 
 
Final Rule; Response to Objections and Denial of Public Hearing Requests; Removal of Administrative 
Stay 
The Food and Drug Administration (FDA or we) is responding to objections that it received from the 
Center for Food Safety on the final rule entitled "Listing of Color Additives Exempt from Certification; 
Soy Leghem oglobin",  published on 1 August  2019. The final rule amended the color additive 
regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef 
analogue products. After reviewing the objections, FDA has concluded that the ob jections do not raise 
issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment 
to the regulations. We are also providing notice that the administrative stay of the effective date for 
this color additive regulat ion is now lifted.  
The final rule published in the Federal Register of 1 August 2019 (84 FR 37573) with an effective date 
of 4 September 2019, was administratively stayed by the filing of objections under section 701(e)(2) 
of the Federal Food, Drug, and Co smetic Act (FD&C Act) (21 U.S.C. 371(e)(2)) as of 
3 September  2019. FDA lifts the administrative stay as of 19 December  2019.  
https://members.wto.org/crnattach ments/2020/SPS/USA/20_0023_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 regulation  
[ ] 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 
comme nt 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) : Not applicable  G/SPS/N/USA/3045/Add.2  
 
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  Agency or authority designated to handle comments: [  ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax number and e -mail address (if available) of other 
body:  
Ellen Anderson, Center  for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740 -3835, Tel: +(1 240) 402 1309  
Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry Point. 
Address, fax number and e -mail address (if available) of other body:  
Text can be found in the Federal Register, Vol. 84, No. 244, page  69620 or on the internet at: 
https://www.govinfo.gov/content/ pkg/FR -2019-12-19/pdf/2019 -27173.pdf   
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