G/SPS/N/USA/3274  
 
14 September 2021  
(21-6816) 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:  Food and Drug Administration (FDA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  HS Code(s): 2003; ICS Code(s): 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:  Monaghan Mushrooms Ireland Unlimited Company; 
Filing of Food Additive Petition . Language(s):  English . Number of pages:  1 
https://www.govinfo.gov/content/pkg/FR -2021-09-09/pdf/2021 -19409.pdf  
https://members.wto.org/crnattachments/2021/SPS/USA/21_5786_00_e.pdf  
6. Description of content:  The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Monaghan Mushrooms Ireland Unlimited 
Company, proposing that the food additive regulations be amended to provide for the safe 
use of vitamin D2 mushroom powder produced by exposing dried and powdered edible 
cultivars of Agaricus bisporus to ultraviolet light.   
The food additive petition was filed on 8 June 2021.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territ ory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/USA/3274  
 
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  9. Other relevant documents and language(s) in which these are available:    
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  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [  ] National Enquiry Point. Address, fax number and e -mail address (if 
availa ble) of other body:   
ADDRESSES: For access to the docket to read background documents or comments 
received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.  
FOR FURTHER INFORMATION CONTACT: Kati e Overbey, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, +(240) 402 7536.  
13. Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry 
Point. Address, fax numb er and e -mail address (if available) of other body:   
Text can be found in the Federal Register, Vol. 86, No. 172, Page  50496  or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2021-09-09/pdf/2021 -19409.pdf