### Extended Determination ofNonregulated Status for T303-3 cotton (Gossypium hirsutum)

Inresponse to a request to extend a determination ofnonregulated status to include insect-resistant, glufosinate ammonium tolerant cotton (12-033-01p) from Bayer CropScience (hereafterreferred to as Bayer), the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has detem1ined that T303-3 cotton and progeny derived from it are unlikelyto pose plantpestrisks and

are no longerto be consideredregulated articles under APHIS' Biotechnology Regulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). This extension request follows closely on APHIS' determination ofnonregulated status ofBayer event T340-40 cottonwhichuses the trade name TwinLinkTM (APHIS petition# 08-340-01p givennonregulated status October 12, 2011). Since APHIS has detennined that T303-3
cotton is unlikelyto pose a plantpest risk, APHIS will approve the request to extend the determination ofnonregulated status to T303-3 cotton. Therefore, APHIS-approved pe1mits or acknowledged notifications that were previouslyrequired for environmental release, interstate movement, orimportation under those regulations will no longerbe required for T303-3 cotton and its progeny. Importation ofT303-3 cotton seeds and other propagative material would still be subject to APHIS foreign quarantine notices at 7 CFRpart 319 and the Federal Seed Actregulations at 7 CFRpart 201.

Bayerdeveloped the antecedent organism, transgenic TwinLinkTM cotton, byhybridizing
cotton event GHB119 (expressing the Cry2Ae protein from Bacillus thuringiensis and phosphinothricin-acetyl-transferase (PAT) protein from the Streptomyces hygroscopicus), with event T304-40 (expressing Cry1Ab from B. thuringiensis and PATproteins). Bayer subsequently submitted apetition for nonregulated status (APHIS petition# 08-340-01p) for TwinLinkTM cotton and APHIS made a determination ofnonregu1ated status on October 12, 2011. The plasmid (designated pTDL004) used to produce event T303-3
cottonwas very similar to the plasmid (pTDL008) used to produce T340-40 cotton and provided only one difference withrespect to the inserted DNA. For event T303-3 cotton the promoter for the Cryprotein was P35S2 derived from Cauliflower Mosaic Virus, whereas the antecedent utilized Ps7s7 from the Subterranean Clover Stunt Virus. All other regulatory sequences and expressedproteins are identical. A similarP35S3 promoter, also from CauliflowerMosaic Virus, is used in both T303-3 and T340-40
cotton to drive expression ofthe PATprotein. In addition, P35S promoters are found in several petitions that have been given non-regulated status by APHIS (four com [petition #'s 00-136-01p, 01-137-01p, 03-353-01p, 04-125-01p], one cotton [00-342-01p], one soybean [09-082-01p], and one plum [04-264-01p]), therefore USDA-APHIS is familiar with the functional role this promoterplays in a variety ofcrops. APHIS is also familiar with the PAT and Cryprotein-expressing plants because these two components havebeen in a number ofcrops given nonregulated status, including cotton, com and rice.

APHIS conducted a Plant Pest Risk Assessment on the antecedent organism, T340-40
cotton. Based on a comparative review ofBayer'srequest to extend nonregulated status to T303-3 insect-resistant, g1ufosinate anm1onium tolerant cotton (12-033-0l'p), APHIS concludes that T303-3 is unlikelyto pose aplantpestrisk and shouldno longerbe subject

1to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340 for the following reasons: (1) disease and insect susceptibility ofT303-3 cotton is similar to that ofits non-genetically engineered cotton counterpart, the antecedent organism, and/or other cotton cultivars grown inthe U.S.; (2) Like the antecedent organism, gene flow and introgression from T303-3 cotton into wildrelatives in the United States and its territories is unlikelyto occur and genetic diversity ofrelated plants is unlikelyto be adversely affected any more so than might occur with cultivation oftraditional or other cotton varieties; (3) T303-3 exhibits no characteristics that would cause it to be weedier ormore difficult to control as a weed than non-genetically engineered cotton, the antecedent organism or any other cultivated cotton; (4) the plant and its gene products (CrylAb and PAT proteins) common to the two events do not pose a risk to non-target organisms, including beneficial organisms; (5) horizontal gene transferbetween T303-3 cotton and organisms with which it cannot interbreed is unlikely to occur.

In addition to our finding that T303-3 cotton is unlikely to pose aplantpest risk, APHIS has made a Finding ofNo Significant Impact (FONSI) for this action based on its similarityto Bayer T340-40 cotton line (a component ofTwinLinkTM cotton) and the Environmental Assessment completed for the petition submitted for that product (APHIS #08-340-0lp). Both T340-40 and T303-3 cotton express CrylAb and PAT proteins. The
progeny ofT303-3 would have no significant impacts, individually or collectively, 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://wvvw.aphis.usda.gov/biotechnology/not reg.html). Similarto APHIS' plant pest risk assessment conclusions.regarding TwinLinkTM cotton, APHIS concludes that new varieties derived from !303-3 cotton are unlikely to exhibit plantpestprope1iies that are substantially different from the ones observed for other cotton varieties not considered regulated articles under 7 CFRpati 340.

Based onmyreview a11d consideration ofall ofthe scientific and environmental data, analyses, information, and previous conclusions regarding the plant pest risk assessment for the antecedent organism (TwinLinkTM cotton), the FONSI that was preparedbased
upon the previous NEPA review completed for TwinLinkTM Cotton, and my knowledge and experience as the DeputyAdministrator ofAPHIS Biotechnology Regulatory Services, I have determined and decided that this determination ofnonregulated status of T303-3 cotton is the most scientifically sound and appropriate regulatory decision.

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

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