Determination ofNonregulated Status for TwinLinkTM cotton 

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In response to petition 08-340-01p from Bayer CropScience (hereafterreferred to as Bayer), the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has detelTIlined that TwinLinkTM cotton and progeny derived from it are unlikely to pose plant pestrisks and are no longerto be considered regulated articles under APHIS' Biotechnology Regulations (Title 7 ofCode ofFederal Regulations (CFR), pa11 340). Since APHIS has detelTIlined that TwinLinFM cotton is unlikely to pose a plant pest risk, APHIS will approve the petition for nonregulated status ofTwinLinkTM cotton. Thereibre, APHIS approved pelTIlits oracknowledged notifications that werepreviously required for environmental release, interstate movement, or importation under those regulations will no longerbe required for TwinLinFM cotton and its progeny. Importation ofTwinLinkTM cotton seeds and other propagative material would still be subject to APHIS foreign quarantine notices at7 CFR part 319 and the Federal Seed Act regulations at 7 CFRpart 201.

This detelmination for TwinLinkTM cotton is based on APHIS' analyses offield and laboratory data submitted by Bayer, references provided in the petition, peer-reviewed publications, and otherrelevant infOlmation as described in the Plant Pest Risk Assessment (PPRA) for TwinLinkTM cotton.

The Plant Pest Risk Assessment conducted on TwinLinkTM cotton concluded that it is unlikely to pose a plantpestrisk and should no longerbe subject to the plantpest provisions ofthe Plant Protection Act and 7CFRpart 340 for the following reasons: (1) disease andinsect susceptibility ofTwinLinkTM cotton is similarto that ofits nongenetical1y engineered cotton counterpart andlorothercotton cultivars grown in the US; (2) gene flow and introgression from TwinLinkTM cotton into wild relatives in the United States and its tenitories is unlikely to occur and genetic diversity ofreJated plants is unlikely to be adversely affected any more so than might occurwith cultivation of traditional orother cotton varieties; (3) they exhibit no characteristics that would cause them to be weedierormore difTIcult to control as weeds than non-genetically engineered cotton or any othercultivated cotton; (4) the plant and its gene products (CrylAb, Cry2Ae and phosphinothricin-acetyl-transferase (PAT) protein) do not pose a risk to nontarget organisms, includingbeneficial organisms; (5) horizontal gene transferbetween TwinLinkTM cotton and organisms with which it cannot interbreed is unlikely to occur.

In addition to ourfinding that TwinLinkTM cotton is unlikely to pose a plantpest risk, APHIS has completed a Final Environmental Assessment (EA) and Finding ofNo Significant Impact (FONSI) for this action and has determined that a detemlination of nonregulated status for TwinLinkTM cotton and its progeny would have no significant impacts, individually or collectively, on the quality ofthehuman environment and will have no effect on federally listed threatened or endangered species, species proposed for listing, ortheir designated orproposed critical habitats (http://www.aphis.usda.gov/biotechnology/not reg.html). APHIS also concludes in its PPRA that new varieties derived from TwinLinkTM cotton are unlikely to exhibitnew plant pest properties that are substantially different from the ones observed forTwinLinkTM cotton, orthose observed for othercotton varieties not considered regulated articles under 7 CFR part 340.

Based on my full and completereview and consideration ofall ofthe scientific and environmental data, analyses, infonnation, and conclusions ofthe PPRA, the Final EA, the agency's Response to Public Comments received in reference to the Draft EA, thc FONSI, and my knowledge and experience as the Deputy AdministratorofAPHIS Biotechnology Regulatory Services, Ihave detem1ined and decided that this detennination ofnonregulated status for TwinLinkD-1 cotton is the most scientifically sound and appropriate regulatory decision.

Michael C. Gregoire Date Deputy Administrator Biote<:hnology Regulatory Services Animal and Plant Health Inspection Service U.S. Department ofAgriculture

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