### Determination 

### ofNonregulated Status for Syngenta COT67B cotton

In response to petition 07-108-0Ip from SyngentaBiotechnology, Inc., the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has determined that event COT67B cotton and progeny derived from it are unlikely to poseplantpest risks and are no longerto be considered regulated articles under APHIS' BiotechnologyRegulations (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 ofCOT67B cotton. Therefore, APHIS approved permits or acknowledged notifications that were previously required for environmental release, importation, orinterstate movement under those regulations will no longerbe required for event COT67B cotton and its progeny. Importation ofCOT67B cotton seeds and otherpropagative material would still be subject
to APHIS foreign quarantine notices at 7 CFR part 319 and the Federal Seed Act regulations at 7 CFRpart 201.

This determination for COT67B is based on APHIS' analysis offield, greenhouse and laboratory data submitted by Syngenta, references provided in the petition, peer-reviewed publications, and otherrelevant 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 longerbe subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpalt 340 for the following reasons: (I) compositional profiles ofCOT67B cotton are similarto those ofits parent line and other cotton cultivars grown in the U.S, therefore no direct orindirectplant pest effects on raw orprocessed plant commodities are expected; (2) it exhibits no characteristics that would cause it to be weedierthan the non-genetically engineeredparent cotton line orany othercultivated cotton; (3) gene introgression from event COT67B cotton into wild relatives in the United States and its territories is extremely unlikely and is not likelyto increase the weediness potential ofanyresultingprogeny nor adversely affect genetic diversity ofrelated plants any more than would introgression from traditional cotton varieties; (4) horizontal gene transfer is unlikely to occurbetween 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 orcollectively, on the quality ofthe human environment and willhave no effect on federally listed threatened or endangered species, species proposed for listing, or their designated orproposed critical habitats (http://www.aphis.usda.govlbrs/not reg.html). APHIS also concludes in its PPRA that new

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varieties derived from COT67B are unlikely to exhibitnewplant pest properties that are substantially different from the ones observed for COT67B cotton, orthose observed for othercotton varieties not considered regulated articles under 7 CFRpart 340.

Based on my full and complete review and consideration ofall ofthe scientific and environmental data, analyses, information, and conclusions ofthe PPRA, the Final EA, the agency's Response to Public Comments received in reference to the DraftEA, the FONSI, and myknowledge and experience as the Deputy Administrator ofAPHIS Biotechnology Regulatory Services, I have determined and decided that this determination of nonregulated status ofCOT67B cotton is the most scientifically sound and appropriate regulatorydecision.



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Michael C. Gregoire Date DeputyAdministrator BiotechnologyRegulatory Services Animal and PlantHealth Inspection Service U.S. Department ofAgriculture