Determination of Nonregulated Status for TwinLinkTM cotton (Gossypium hirsutum) 

In response to petition 08-340-01 p from Bayer CropScience (hereafter referred to as 

Bayer), the Animal and Plant Health Inspection Service (APHIS) of the United States 

Department of Agriculture (USDA) has detelTIlined that TwinLinkTM 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 of Federal 

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 

ofTwin LinkTM cotton. Thereibre, APHIS approved pelTIlits or acknowledged 

notifications that were previously required for environmental release, interstate 

movement, or importation under those regulations will no longer be required for 

TwinLinFM cotton and its progeny. Importation ofTwinLinkTM 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 detelmination for TwinLinkTM cotton is based on APHIS' analyses of field and 

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

publications, and other relevant 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 plant pest risk and should no longer be subject to the plant pest 

provisions of the Plant Protection Act and 7 CFR part 340 for the following reasons: (1) 

disease and insect susceptibility of TwinLinkTM cotton is similar to that ofits nongenetical1y engineered cotton counterpart andlor other cotton 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 occur with cultivation of 

traditional or other cotton varieties; (3) they exhibit no characteristics that would cause 

them to be weedier or more difTIcult to control as weeds than non-genetically engineered 

cotton or any other cultivated cotton; (4) the plant and its gene products (CrylAb, 

Cry2Ae and phosphinothricin-acetyl-transferase (PAT) protein) do not pose a risk to nontarget organisms, including beneficial organisms; (5) horizontal gene transfer between 

TwinLinkTM cotton and organisms with which it cannot interbreed is unlikely to occur. 

In addition to our finding that TwinLinkTM cotton is unlikely to pose a plant pest risk, 

APHIS has completed a Final Environmental Assessment (EA) and Finding of No 

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 ofthe 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.gov/biotechnology/not reg.html). APHIS also concludes in its 

PPRA that new varieties derived from TwinLinkTM cotton are unlikely to exhibit new 

plant pest properties that are substantially different from the ones observed for 
TwinLinkTM 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, 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 Administrator of APHIS 

Biotechnology Regulatory Services, I have detem1ined and decided that this 

detennination of nonregulated 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 of Agriculture 

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