Determination of Nonregulated Status for Syngenta COT67B cotton 

In response to petition 07-108-0Ip from Syngenta Biotechnology, Inc., the Animal and 

Plant Health Inspection Service (APHIS) of the United States Department of Agriculture 

(USDA) has determined that event COT67B cotton and progeny derived from it are 

unlikely to pose plant pest risks and are no longer to be considered regulated articles under 

APHIS' Biotechnology Regulations (Title 7 ofCode ofFederal Regulations (CFR), part 

340). Since APHIS has determined that COT67B cotton is unlikely to pose plant pest 

risks, APHIS will approve the petition for nonregulated status of COT67B cotton. 

Therefore, APHIS approved permits or acknowledged notifications that were previously 

required for environmental release, importation, or interstate movement under those 

regulations will no longer be required for event COT67B cotton and its progeny. 

Importation of COT67B cotton seeds and other propagative material would still be subject 

to APHIS foreign quarantine notices at 7 CFR part 319 and the Federal Seed Act 

regulations at 7 CFR part 201. 

This determination for COT67B is based on APHIS' analysis of field, greenhouse and 

laboratory data submitted by Syngenta, references provided in the petition, peer-reviewed 

publications, and other relevant information as described in the Plant Pest Risk Assessment 

(PPRA) for COT67B. 

The Plant Pest Risk Assessment conducted on COT67B concluded that it is unlikely to 

pose plant pest risks and should no longer be subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR palt 340 for the following reasons: (I) compositional 

profiles of COT67B cotton are similar to those of its parent line and other cotton cultivars 

grown in the U.S, therefore no direct or indirect plant pest effects on raw or processed 

plant commodities are expected; (2) it exhibits no characteristics that would cause it to be 

weedier than the non-genetically engineered parent cotton line or any other cultivated 

cotton; (3) gene introgression from event COT67B cotton into wild relatives in the United 

States and its territories is extremely unlikely and is not likely to increase the weediness 

potential of any resulting progeny nor adversely affect genetic diversity ofrelated plants 

any more than would introgression from traditional cotton varieties; (4) horizontal gene 

transfer is unlikely to occur between COT67B cotton and organisms with which it cannot 

interbreed; (5) disease and insect susceptibilities are similar to other cotton cultivars grown 

in the U.S. ; and (6) it does not pose a risk to non-target organisms, including beneficial 

orgamsms. 

In addition to our finding that event COT67B is unlikely to pose a plant pest risk, APHIS 

has completed a Final Environmental Assessment (EA) and FONSI for this action and has 

determined that a determination ofnonregulated status for COT67B and its progeny would 

have no significant impacts, individually or collectively, on the quality of the human 

environment and will have no effect on federally listed threatened or endangered species, 

species proposed for listing, or their designated or proposed critical habitats 

(http://www.aphis.usda.govlbrs/not reg.html). APHIS also concludes in its PPRA that new 
..... 


varieties derived from COT67B are unlikely to exhibitnew plant pest properties that are 

substantially different from the ones observed for COT67B cotton, or those observed for 

other cotton varieties not considered regulated articles under 7 CFR part 340. 

Based on my full and complete review and consideration of all of the scientific and 

environmental data, analyses, information, and conclusions of the PPRA, the Final EA, the 

agency's Response to Public Comments received in reference to the Draft EA, the FONSI, 

and my knowledge and experience as the Deputy Administrator ofAPHIS Biotechnology 

Regulatory Services, I have determined and decided that this determination of 

nonregulated status of COT67B cotton is the most scientifically sound and appropriate 

regulatory decision. 

<ii - 23 -// 

Michael C. Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture