. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2376 
25 May 2012  
 (12-2767) 
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 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where applicable):  Seeds for sprouting 
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:  Irradiation in the Production, Processing and Handling of 
Food;  Final rule;  denial of requests for a hearing and response to objections  Language(s):  
English  Number of pages:  4 
 http://www.gpo.gov/fdsys/pkg/FR -2012-05-11/pdf/2012-11391.pdf  
6. Description of content:  The US Food and Drug Administration (FDA) is denying requests 
for a hearing on the final rule that amended th e food additive regulations to provide for the 
safe use of ionizing radiation for the control of microbial pathogens in seeds for sprouting.  
After reviewing objections to the final rule and requests for a hearing, FDA has concluded 
that the objections do not justify a hearing or otherwise provide a basis for revoking the 
regulation.  In this notice, FDA addresses ea ch of the objections which included application 
of 100-Fold Safety Factor;  procedures; toxico logy issues;  radiolysis products;  nutritional 
considerations;  and labeling concerns, as we ll as the evidence and information filed in 
support of each, comparing each objection and th e information submitted in support of it to 
the standards for granting a hearing in US$12.24(b). 
On 16 August 1999 (64 FR 44530), FDA published a notice announcing the filing of a food 
additive petition to amend the regulations in part 179 Irradiation in the Production, 
Processing, and Handling of Food (21 CFR pa rt 179) by providing for the safe use of 
ionizing radiation to control microbial pathogens in seeds for sprouting.  In response to this 
petition, FDA issued a final rule in the Fede ral Register of 30 Octo ber 2000 (65 FR 64605), 
permitting the irradiation of seeds for sprouting to control microbial pathogens in alfalfa 
and other sprouting seeds at an absorbed dose not to exceed 8.0 kiloGray (kGy) (hereafter 
referred to as the "seeds for sprouting rule").  FDA based its decision on data in the petition 
and in its files.  The preamble to the final ru le advised that objections to the final rule and 
requests for a hearing were due within 30 days of the publication date (i.e., by 29 November 2000). G/SPS/N/USA/2376 
Page 2  
 
  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 stan dard?  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 standard?   
 [ ] 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:   
Federal Register of 16 August 1999 (64 FR  44530) FDA publication of notice announcing 
the filing of a food additive petition (FAP 9M4673)  
Federal Register of 30 October 2000 (65 FR  64605), FDA issuance of a final rule 
(available in English) 
10. Proposed date of adoption (dd/mm/yy) :  30 October 2000 
Proposed date of publication (dd/mm/yy) :  30 October 2000 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  30 October 2000 
[X] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Objections to the rule have already been filed.  No comments due. 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  Teresa A. Croce,  Center for Fo od Safety and Applied Nutrition 
(HFS 265), US Food and Drug Administration, 5100 Paint Branch Pkwy.,College Park, MD 20740, 011.240.4 02.1281,  Teresa.Croce@fda.hhs.gov 
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 Authority, USDA Fore ign 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.s psenquirypoint@fas.usda.gov