. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1462/Add.1 
19 April 2007 
 (07-1620) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
NOTIFICATION 
 
Addendum
 
   The following communication, received on 16 April 2007, is being circulated at the request of 
the delegation of the United States. 
 
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Pesticide Product Registration Approval;  Request for Comments
 
 
 This regulation establishes a temporary exemption from the requirement of a tolerance for 
residues of the Bacillus thuringiensis Vip3Aa20 pr otein and the genetic material necessary for its 
production in corn when applied or used as a plant-in corporated protectant.  This regulation eliminates 
the need to establish a maximum permissible leve l for residues of Bacillus thuringiensis Vip3Aa20 
protein and the genetic material necessary for its production in corn when applied or used as a plant-
incorporated protectant on field corn, sweet corn, and popcorn.  The temporary tolerance exemption 
expires on 31 March 2008.   Objections and requests for hearings must be received on or before 4 June 2007, and may be 
identified by docket number EPA-HQ-OPP-2006-0783 . 
 
This notice can be found at:  Federal Regist er: 4 April 2007 (Volume 72, Number 64) Rules 
and Regulations Page 16277- 16281; http://www.epa.gov/fedrgstr/EPA-PEST/2007/April/Day-
04/p6256.htm.  
 This action is subsequent to a notification f iled in the Federal Register of 1 November 2006 
(71 FR 64269) in which EPA issued a notice announc ing the filing of a pesticide tolerance petition 
(PP 6G7091) requesting a temporary exemption from the requirement of a tolerance for residues of 
the Bacillus thuringiensis Vip3Aa20 protein and the genetic material necessary for its production in 
corn when applied or used as a plant-incorporated  protectant on field corn, sweet corn, and popcorn.  
One comment was received in response to the not ice of filing.  The commenter objected to an 
exemption from the requirement of tolerance a nd expressed opposition to genetic alterations.  The 
Agency understands the commenter's concerns and recognizes that some individuals believe that 
genetically modified crops and food should be co mpletely banned. EPA conducted a comprehensive 
assessment of the Vip3Aa20 protein and the genetic  material necessary for its production in corn, 
including a review of acute oral toxicity data and amino acid sequence comparisons to known toxins 
and allergens.  In addition, data were reviewed th at demonstrate that the Vip3Aa20 protein is rapidly 
degraded by gastric fluid in vitro, is not glycosyl ated, and is present in low levels in corn tissue.  
Based on these data, EPA concluded that there is a reasonable certainty that no harm will result from 
dietary exposure to this protein as expressed in gene tically modified corn.  This notice can be found 
at:  Federal Register: 1 November 2006 (Vol ume 71, Number 211) Notices Page 64268-64269; 
http://www.epa.gov/fedrgstr/EPA-PEST/ 2006/November/Day-01/p18425.htm . 
 G/SPS/N/USA/1462/Add.1 
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  United States SPS National Notification Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), St op 1027, Washington D.C. 20250. Tel: 202-720-1301; 
Fax 202-690-0677; Email: fstsd@fas.usda.gov.  
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