Extended Determination ofNonregulated Status for T303-3 cotton (Gossypium 

hirsutum) 

In response to a request to extend a determination ofnonregulated status to include 

insect-resistant, glufosinate ammonium tolerant cotton (12-033-01p) 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 detem1ined 

that T303-3 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 of Code ofFederal Regulations (CFR), part 340). This extension 

request follows closely on APHIS' determination ofnonregulated status ofBayer event 

T340-40 cotton which uses the trade name TwinLinkTM (APHIS petition# 08-340-01p 

given nonregulated status October 12, 2011). Since APHIS has detennined that T303-3 

cotton is unlikely to pose a plant pest 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 previously required for environmental 

release, interstate movement, or importation under those regulations will no longer be 

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 

CFR part 319 and the Federal Seed Act regulations at 7 CFR part 201. 

Bayer developed the antecedent organism, transgenic TwinLinkTM cotton, by hybridizing 

cotton event GHB 119 (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 PAT proteins). Bayer 

subsequently submitted a petition 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 

cotton was very similar to the plasmid (pTDL008) used to produce T340-40 cotton and 

provided only one difference with respect to the inserted DNA. For event T303-3 cotton 

the promoter for the Cry protein was P35S2 derived from Cauliflower Mosaic Virus, 

whereas the antecedent utilized Ps7s7 from the Subterranean Clover Stunt Virus. All 

other regulatory sequences and expressed proteins are identical. A similar P35S3 

promoter, also from Cauliflower Mosaic Virus, is used in both T303-3 and T340-40 

cotton to drive expression of the PAT protein. 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 promoter plays in a variety of crops. APHIS is also familiar 

with the PAT and Cry protein-expressing plants because these two components have been 

in a number of crops 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 of Bayer's request to extend nonregulated status 

to T303-3 insect-resistant, g1ufosinate anm1onium tolerant cotton (12-033-0l'p), APHIS 

concludes that T303-3 is unlikely to pose a plant pest risk and should no longer be subject 

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to the plant pest provisions of the Plant Protection Act and 7 CFR part 340 for the 

following reasons: (1) disease and insect susceptibility ofT303-3 cotton is similar to that 

of its non-genetically engineered cotton counterpart, the antecedent organism, and/or 

other cotton cultivars grown in the U.S.; (2) Like the antecedent organism, gene flow and 

introgression from T303-3 cotton into wild relatives in the United States and its territories 

is unlikely to occur and genetic diversity of related plants is unlikely to be adversely 

affected any more so than might occur with cultivation of traditional or other cotton 

varieties; (3) T303-3 exhibits no characteristics that would cause it to be weedier or more 

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 transfer between 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 a plant pest risk, APHIS 

has made a Finding ofNo Significant Impact (FONSI) for this action based on its 

similarity to 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 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://wvvw.aphis.usda.gov/biotechnology/not reg.html). Similar to APHIS' 

plant pest risk assessment conclusions. regarding TwinLink TM cotton, APHIS concludes 

that new varieties derived from !303-3 cotton are unlikely to exhibit plant pest prope1iies 

that are substantially different from the ones observed for other cotton varieties not 

considered regulated articles under 7 CFR pati 340. 

Based on my review a11d consideration of all of the 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 prepared based 

upon the previous NEP A review completed for TwinLinkTM Cotton, and my knowledge 

and experience as the Deputy Administrator of APHIS Biotechnology Regulatory 

Services, I have determined and decided that this determination of nonregulated status of 

T303-3 cotton is the most scientifically sound and appropriate regulatory decision. 

Michael C. Gregoire 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

Date 

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