NATIONAL ENVIRONMENTAL POLICY ACT DECISION 

AND 

FINDING OF NO SIGNIFICANT IMPACT 

Bayer CropScience 

Insect Resistant and Glufosinate Ammonium-Tolerant Cotton 

Transformation Event T303-3 

United States Department of Agriculture 

Animal and Plant Health Inspection Service 

Biotechnology Regulatory Services 

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection 

Service (APHIS) has developed this decision document to comply with the requirements of the 

National Environmental Policy Act (NEPA) of 1969, as amended, the Council ofEnvironmental 

Quality's (CEQ) regulations implementing NEP A, and the USDA APHIS' NEP A implementing 

regulations and procedures. This NEPA decision document, a Finding of No Significant Impact 

(FONSI), sets forth APHIS' NEP A decision and its rationale. 

Bayer CropScience (BCS) submitted a request to APHIS in February 2012 for an extension of a 

determination of nonregulated status for a genetically engineered (GE) insect-resistant, 

glufosinate ammonium tolerant cotton event T303-3 (Event T303-3). A person may petition the 

agency that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no 

longer regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 

CFR 340. A person may request that APHIS extend a determination of nonregulated status to 

other organisms under§ 340.6(e)(2) of the regulations. Such a request shall include information 

to establish the similarity of the antecedent organism and the regulated articles in question. A 

GE organism is no longer subject to the regulatory requirements of7 CFR part 340 or the plant 

pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a 

plant pest risk. APHIS reviewed and analyzed the information submitted in the extension 

request by BCS (Bayer 2012) and has concluded that Event T303-3 is similar to the antecedent 

organism, event T304-40 and therefore, based on its Plant Pest Risk Assessment for TwinLinkTM 

cotton (USDA-APHIS 2010) APHIS has concluded that Event T303-3 is unlikely to pose a plant 

pest risk (see Appendix A). 

The petition for TwinLinkTM Cotton Events GHB119 and T304-40 (08-340-01p) received a 

determination of non-regulated status from APHIS on October 12, 2011 (76 FR 63278-63279). 

TwinLinkTM Cotton is a combined-trait cotton developed using conventional breeding techniques 

to link two deoxyribonucleic acid (DNA) transformation events; each developed using DNA 

recombinant techniques. By crossing BCS' Cry1Ab Cotton (event T304-40) with BCS' Cry2Ae 

Cotton (event GHB119), BCS has developed a cotton resistant to lepidopteran pests. The 

TwinLinkTM Cotton also expresses a glufosinate ammonium herbicide tolerance trait based on 

LibertyLink® technology. In accordance with§ 340.6(e)(2), BCS requests this determination of 

nonregulated status ofTwinLinkTM Cotton from APHIS be extended to Event T303-3 and any 

progeny derived from crosses of Event T303-3 with conventional cotton, and any progeny 

derived from crosses of Event T303-3 with other transgenic cotton varieties that have received a 

1 
I '. 

determination of nomegulated status, no longer be considered regulated articles under 7 CFR 

Part 340. Event T303.:3 is currently regulated under 7 CFR part 340. Interstate movements and 

field trials of Event T303-3 have been conducted under permits issued or notifications 

acknowledged by APHIS since 2001. Data resulting from these field trials are described in BCS 

application for extension (Bayer 2012). 

In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS completed 

an Environmental Assessment (EA) and NEP A Decision/FONSI that analyzed the potential 

impacts to the human environment1 from a determination on the regulated status of a petition 

request (APHIS Number 08-340-01p) by BCS for their genetically engineered TwinLinkTM 

Cotton Events GHB119 and T304-40 in 2011 (76 FR 63278-63279). The EA assessed 

alternatives to a determination ofnomegulated status ofTwinLinkTM Cotton and analyzed the 

potential environmental and social effects that result from the proposed action and the 

alternatives. APHIS has carefully examined the existing NEP A documentation completed for 

TwinLinkTM Cotton and has concluded that the BCS extension request for a determination of 

nomegulated status of Event T303-3 encompasses the same scope of environmental analysis as 

TwinLinkTM Cotton. This conclusion is based on: 

• Event T303-3 expresses the same Cry1Ab and PAT/bar proteins as event T304-40; 

• Event T303-3 expresses the same resistance to lepidopteran pests and glufosinate 

ammonium herbicide tolerance as TwinLinkTM Cotton; 

• Event T303-3 does not exhibit any additional traits beyond what is expressed in 

TwinLinkTM Cotton; 

• the extension request for Event T303-3 encompasses the same regulatory action as 

TwinLinkTM Cotton, that is a determination of nomegulated status under 7 CFR part 340; 

• the affected environment, issues and alternatives described and analyzed in the existing 

NEP A documentation for TwinLinkTM Cotton are applicable to the extension request of 

Event T303-3; · 

• no new alternatives have been identified that are relevant to this regulatory action; 

• no substantive new environmental or social issues and impacts have been identified that 

are relevant to this regulatory action; and 

• APHIS is not aware of any substantive new information that would warrant alteration of 

the existing NEP A documentation for TwinLinkTM Cotton, including the proposed action 

or analysis of impacts in the EA; 

Based on its similarity to the antecedent organism event T304-40, the BCS extension request for 

Event T303-3 has been subject to the previous NEPA review completed for TwinLinkTM Cotton. 

Therefore, the existing NEP A documentation completed for TwinLinkTM Cotton is being used to 

evaluate and determine if there are any potentially significant impacts to the human enviroriment 

from APHIS' response to BCS extension request for a determination .of nomegulated status of 

Event T303-3. 

Regulatory Authority 

t Under NEP A regulations, the "human environment" includes "the natural and physical environment and the 

relationship of people with that environment" (40 CFR §508.14). 

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"Protecting American agriculture" is the basic charge of APHIS. APHIS provides leadership in 

ensuring the health and care of plants and animals. The agency improves agricultural 

productivity and competitiveness, and contributes to the national economy and the public health. 

USDA asserts that all methods of agricultural production (conventional, organic, or the use of 

GE varieties) can· provide benefits to the environment, consumers, and farm income. 

Since 1986, the United States government has regulated GE organisms pursuant to a regulatory 

framework known as the Coordinated Framework for the Regulation of Biotechnology 

(Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, 

published by the Office of Science and Technology Policy, describes the comprehensive federal 

regulatory policy for ensuring the safety of biotechnology research and products and explains 

how federal agencies will use existing Federal statutes in a manner to ensure public health and 

environmental safety while maintaining regulatory flexibility to avoid impeding the growth of 

the biotechnology industry. The Coordinated Framework is based on several important guiding 

principles: (1) agencies should define those transgenic organisms subject to review to the extent 

permitted by their respective statutory authorities; (2) agencies are required to focus on the 

characteristics and risks of the biotechnology product, not the process by which it is created; (3) 

agencies are mandated to exercise oversight of GE organisms only when there is evidence of 

"unreasonable" risk. 

The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA's APHIS, the Food and Drug 

Administration (FDA), and the Environmental Protection Agency (EPA). 

APHIS is responsible for regulating GE organisms and plants under the plant pest provisions in 

the Plant Protection Act of2000, as amended (7 USC§ 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment. 

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic 

Act. The FDA is responsible for ensuring the safety and proper labeling of all plant-derived 

foods and feeds, including those that are genetically engineered. To help developers of food and 

feed derived from GE crops comply with their obligations under Federal food safety laws, FDA 

encourages them to participate in a voluntary consultation process. All food and feed derived 

from GE crops currently on the market in the United States have successfully completed this 

consultation process. The FDA policy statement concerning regulation of products derived from 

new plant varieties, including those genetically engineered, was published in the Federal Register 

on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a 

consultation process to ensure that human food and animal feed safety issues or other regulatory 

issues (e.g., labeling) are resolved prior to commercial distribution ofbioengineered food. 

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides on and in 

food and animal feed, or establishes an exemption from the requirement for a tolerance, under 

the Federal Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control 

organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for 

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regulating the sale, distribution and use of pesticides, including pesticides that are produced by 

an organism through techniques of modem biotechnology. 

Regulated Organisms 

The APHIS Biotechnology Regulatory Service's (BRS) mission is to protect America's 

agriculture and environment using a dynamic and science-based regulatory framework that 

allows for the safe development and use of GE organisms. APHIS regulations at 7 CFR part 

340, which were promulgated pursuant to authority granted by the Plant Protection Act, as 

amended (7 USC 7701-7772), regulate the introduction (importation, interstate movement, or 

release into the environment) of certain GE organisms and products. A GE organism is no 

longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory 

requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a plant pest 

risk. A GE organism is considered a regulated article if the donor organism, recipient organism, 

vector, or vector agent used in engineering the organism belongs to one ofthe taxa listed in the 

regulation (7 CFR 340.2) and is also considered a plant pest. AGE organism is also regulated 

under Part 340 when APHIS has reason to believe that the GE organism may be a plant pest or 

APHIS does not have information to determine if the GE organism is unlikely to pose a plant 

pest risk. 

A person may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant 

Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide information 

under§ 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

person may also request that APHIS extend a determination of nonregulated status to other 

organisms under § 340.6( e )(2). Such a request shall include information to establish the 

similarity of the antecedent organism and the regulated articles in question. AGE organism is 

no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of 

the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. 

APHIS' Response to Application for an Extension of Nonregulated Status 

Under the authority of the plant pest provisions of the Plant Protection Act and 7 CFR part 340, 

APHIS has issued regulations for the safe development and use ofGE organisms. As required 

by § 340.6, APHIS must respond to petitioners who request a determination ofthe regulated 

status of GE organisms, including GE plants such as Event T303-3. When a request for an 

extension of nonregulated status is submitted, APHIS must make a determination if the GE 

organism is similar to an antecedent organism which has previously been determined to be 

unlikely to pose a plant pest risk. If APHIS determines based on its Plant Pest Risk Assessment 

(PPRA) of the antecedent organism that the genetically engineered organism identified in the 

extension request is unlikely to pose a plant pest risk, the genetically engineered organism is no 

longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFR part 340. 

BCS has submitted a request to APHIS for an extension of a determination of nonregulated 

status for an insect-resistant, glufosinate ammonium tolerant cotton event T303-3. In accordance 

with§ 340.6(e)(2), BCS requests APHIS' determination ofnonregulated status for TwlnLinkTM 

Cotton be extended to Event T303-3 and any progeny derived from crosses of Event T303-3 with 

4 
conventional cotton, and any progeny derived from crosses of Event T303-3 with other 

transgenic cotton varieties that have received a determination of nonregulated status, no longer 

be considered regulated articles under 7 CFR part 340. The antecedent organism identified in the 

extension request for Event T303-3 is Event T304-40 (Bayer 2012). The petition for 

TwinLinkTM Cotton Events GHB119 and T304-40 (08-340-01p) received a determination of 

non-regulated status from APHIS on October 12, 201,1 (76 FR 63278-63279). 

BSC Cotton Event T303-3 

BCS has developed Event T303-3 as an insect-resistant and glufosinate ammonium tolerant 

cotton. Gossypium hirsutum transformation event T303-3 was produced by Agrobacteriummediated transformation utilizing vector pTDL004 containing a cry lAb gene construct, encoding 

insect-resistance, and the bar gene as a selectable marker conferring tolerance to glufosinate 

ammonium herbicides. The antecedent organism, cotton event T304-40 as described in petition 

08-340-01p for TwinLinkTM Cotton (Bayer 2010), was also generated throughAgrobacteriummediated transformation utilizing a slightly different vector (pTDL008). Both events produce 

the same insecticidal crystal protein (ICP) Cry1Ab (expression product of the cry lAb gene) and 

PAT protein (expression product of the bar gene). A comparison of characteristics of events 

T303-3 and T304-40 is summarized in Table 1 ofBCS application for extension (Bayer 2012). 

Coordinated Framework Review 

Food and Drug Administration 

Similar to the antecedent organism event T304-40, Event T303-3 is within the scope of the 1992 

FDA policy statement concerning regulation of products derived from new plant varieties, 

including those developed through biotechnology (US-FDA 1992). APHIS considers the FDA 

food and feed safety and nutritional assessment determination when assessing potential impacts 

that may result from a determination of nonregulated status of a GE organism. In the absence of 

a completed FDA determination, APHIS takes into consideration prior FDA reviews of 

comparable products to make a preliminary assessment of the potential impacts. Based on the 

similarity to the antecedent organism event T304-40, the conclusions made by FDA for 

TwinLinkTM Cotton are being used to assess potential impacts that may result from a 

determination ofnonregulated status ofEvent T303-3. 

BCS provided the FDA with information on the identity, function, and characterization of the 

genes, for TwinLinkTM Cotton, including expression of the gene products. FDA evaluated BCS 

submission to determine whether the developer's product raises any safety or regulatory issues 

with respect to the intended modification or with respect to the food itself. Based on the 

information provided by BCS and other information available to the agency, FDA did not 

identify any safety or regulatory issues under the Federal Food, Drug and Cosmetic Act or 

current FDA regulations that would require further evaluation at this time (US-FDA 2011). BCS 

has concluded that cotton derived from events T304-40 and GHB119 and the foods and feeds 

obtained from these events are as safe as conventional cotton varieties and with the exception of 

the plant-incorporated protectant proteins, are not materially different in composition or any 

other relevant parameter from other cotton varieties now grown, marketed, and consumed in the 

U.S. At this time, based on BCS' data and information, the FDA considers BCS' consultation on 

cotton derived from events T304-40 and GHB119 to be complete (US-FDA 2011). The FDA's 

oversight of the food and safety impacts associated with the incorporation and expression of 

5 
pesticidal substances, in this case, the Cry proteins associated with Bt, are more limited. EPA is 

the primary authority for the review of plant-incorporated protectants. 

Environmental Protection Agency 

The EPA has authority over the use of pesticidal substances and plant-incorporated protectants 

(PIPs) under the FIFRA as amended (7 USC §136, et seq.) and the FFDCA (21 USC §301, et 

seq.). APHIS considers the EPA's regulatory assessment when assessing potential impacts that 

may result from a determination of nonregulated status of a GE organism. Note that EPA has 

issued a tolerance exemption for Cry1Ab protein in all crops ( 40 CFR § 174.511; US-EPA 

2010a), as well as for the PAT protein (40 CFR §174.522; US-EPA 2010c). A temporary 

exemption from the requirement of a tolerance has been issued for Cry2Ae ( 40 CFR § 174.530; 

US-EPA 2010b). 

BCS developed and sought EPA registration of two transgenic cotton (Gossypium hirsutum) 

PIPs, Event T304-40 and Event GHB 119. Each expresses an insecticidal protein ("Cry'' 

proteins) derived from the soil bacterium Bacillus thuringiensis. These cotton events are 

intended for use as PIPs for conventional breeding to produce a product, TwinLinkTM Cotton that 

expresses both proteins. BCS applied for EPA pesticide registrations of Cry1Ab and Cry2Ae 

proteins as expressed in Events T304-40 and GHB119 cotton, respectively, and a new 

combination PIP product, TwinLinkTM cotton, created through conventional breeding of these 

events for use as PIPs in 2009, under section 3 of the FIFRA. BCS concurrently filed a petition 

for a permanent exemption from the requirement of a tolerance for Cry2Ae protein residues in or 

on food and feed commodities in cotton. EPA believes that, based upon its assessment ofthe 

data and information submitted by BCS, it is in the interest of the public and the environment to 

issue the registrations proposed by BCS (US-EPA 2012). 

In addition to review ofthe crop with plant-incorporated protectants, EPA has authority under 

FIFRA to establish pesticide use restrictions; these use restrictions are presented on pesticide 

labels which are prepared during the pesticide registration process. The development of a 

transformed cotton crop providing tolerance to glufosinate ammonium may require a change in 

the EPA-approved label for this herbicide. The current glufosinate ammonium label provides for 

its use on transformed crops expressing resistance to glufosinate ammonium, and specifically 

references products marketed under the trade name "LibertyLink" (BCS 201 0). Glufosinate · 

ammonium-tolerant cotton was first available in the U.S. with the introduction of Liberty Link® 

Cotton in 2004. Although the glufosinate ammonium tolerance trait expressed in TwinLinkTM 

cotton is the same as that expressed in the Liberty Link® Cotton, the EPA is expected to publish a 

new label for glufosinate ammonium that also references the TwinLinkTM product varieties. 

APHIS used the current glufosinate label as the basis for its evaluation of the potential impacts 

associated with the use of and exposure to glufosinate ammonium. 

Scope of the Environmental Analysis 

Based on the similarity to the antecedent organism event T304-40, APHIS has concluded that the 

BCS extension request for a determination on the regulated status for Event T303-3 encompasses 

the same scope of environmental analysis as TwinLinkTM Cotton. APHIS reviewed and analyzed 

the information submitted in the extension request by BCS (Bayer 2012) and has concluded that 

Event T303-3 is similar to the antecedent organism, event T304-40 and therefore, based on its 

6 
Plant Pest Risk Assessment for TwinLinkTM cotton (USDA-APHIS 2010) APHIS has concluded 

that Event T303-3 is unlikely to pose a plant pest risk (see Appendix A). Although a 

determination ofnonregulated status of Event T303-3 would allow for new plantings of Event 

T303-3 to occur anywhere in the U.S., APHIS primarily focused the environmental analysis to 

those geographic areas that currently support cotton production. Similar to the antecedent 

organism event T304-40, a determination ofnonregulated status of Event T303-3 is not 

expected to increase cotton production, either by its availability alone or accompanied by other 

factors, or cause an increase in overall GE cotton acreage. To determine areas of cotton 

production, APHIS used data from the National Agricultural Statistics Service (NASS) 2007 

Census of Agriculture to determine where cotton is produced in the U.S. (USDA-NASS 2007; 

USDA-NASS 2010). Cotton was produced in 17 states including Alabama, Arizona, Arkansas, 

California, Florida, Georgia, Kansas, Louisiana, Mississippi, Missouri, New Mexico, North 

Carolina, Oklahoma, South Carolina, Tennessee, Texas, and Virginia. 

Public Involvement 

APHIS is not aware of any substantive new information that would warrant alteration of the 

existing NEP A documentation for TwinLinkTM Cotton, including the proposed action or analysis 

of impacts in the EA since the completion of the public involvement process for TwinLinkTM 

Cotton. APHIS has not received any additional information or comments from the public 

specifically directed at the TwinLinkTM Cotton petition, PPRA or NEPA documentation since a 

determination of non-regulated status was announced on October 12, 2011 (76 FR 63278-

63279). 

In preparing this NEPA decision/FONSI for Event T303-3, APHIS carefully reviewed .and took 

into consideration all public input that was received during the public involvement process that 

was completed for Bayer CropScience petition 08-340-01p (TwinLinkTM Cotton). On June 28, 

2011, APHIS published a notice in the Federal Register (76 FR 37769-37770, Docket no. 

APHIS-2010-0102) announcing the availability ofthe Bayer CropScience petition 08-340-01p 

(TwinLinkTM Cotton), and the APHIS PPRA and draft EA for a 60-day public review and 

comment period. Comments were required to be received on or before August 29, 2011. All 

comments were carefully analyzed to identify new issues, alternatives, or information. A total of 

2 comment responses were received from individuals during the comment period. No new 

issues, alternatives or substantive new information were identified in any of the comments 

received by APHIS. The 2 comments expressed opposition to a determination ofnonregulated 

status ofTwinLinkTM Cotton, but did not change the analysis provided in the PPRA or draft EA. 

These individuals did not mention their specific disagreement with APHIS' analyses of 

TwinLinkTM Cotton detailed in the EA or the PPRA (USDA-APHIS 2010); rather, they 

expressed their general opposition to genetically modified organisms (GMOs) or GE crops. 

Other claims suggest a negative impact of GE cotton and GE plants on human health and 

environmental safety in a general nature. Overall, people who expressed their opposition to a 

deterrn,ination of nonregulated status did not provide any supporting evidence for their claims. 

Comment documents may be viewed at 

http://www .regulations. gov/#l searchResults;dct=PS;rpp= 1 O;po=O;s=aphis~20 10-0102 

Major Issues Addressed in the EA 

APHIS has concluded that the BCS extension request for a determination of nomegulated 

status of Event T303-3 encompasses the same scope of environmental analysis as 

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TwinLinkTM Cotton. APHIS is not aware of any substantive new environmental or social 

issues associated with Event T303-3 that were not considered in the previous NEPA analysis 

completed for a determination on the regulated status of a petition request for TwinLinkTM 

Cotton. Therefore, APHIS is using the same issues identified and analyzed in the existing 

NEP A documentation for TwinLinkTM Cotton to evaluate and determine if there are any 

potentially significant impacts to the human environment from a determination on the regulated 

status of an extension request by BCS for Event T303-3. 

The issues considered in the TwinLinkTM Cotton EA were developed based on APHIS' 

determination that certain genetically engineered organisms are no longer subject to the plant 

pest provisions of the Plant Protection Act and 7 CFR part 340, and for this particular EA, the 

specific petition seeking a determination ofnonregulated status ofTwinLinkTM Cotton. Issues 

discussed in the EA were developed by considering public concerns as well as issues raised in 

public comments submitted for other environmental assessments of genetically engineered 

organisms, concerns raised in lawsuits, as well as those issues that have been raised by various 

stakeholders. These issues, including those regarding the agricultural production of cotton using 

various production methods, and the environmental and food/feed safety of genetically 

engineered plants were addressed to analyze the potential environmental impacts of TwinLinkTM 

Cotton. 

The TwinLink TM Cotton EA describes the alternatives considered and evaluated using the 

identified issues. The following issues were identified as important to the scope of the analysis 

(40 CFR 1508.25) for TwinLinkTM Cotton. These same issues have been determined by APHIS 

to be relevant to APHIS' regulatory actions associated with Event T303-3 and therefore are 

being used in their entirety: 

Management Considerations 

• Acreage and Areas of Cotton Production 

• Cropping Practices 

• Seed Production 

• Organic Farming 

• Specialty Cotton Production 

Environmental Considerations 

• Water Resources 

• Soil 

• Air Quality 

• Climate Change 

• Animals 

• Plants 

• Biological Diversity 

• Gene Movement 

Public Health Considerations 

• Human Health 

• Worker Safety 

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• Animal Feed 

Socioeconomic Considerations 

• Domestic Economic Environment 

• Trade Economic Environment 

• Social Environment 

Alternatives that were analyzed 

APHIS has concluded that the BCS extension request for a determination of nonregulated status 

of Event T303-3 encompasses the same scope of environmental analysis and regulatory decision 

as TwinLinkTM Cotton; that is a determination of nonregulated status under 7 CFR part 340. 

APHIS reviewed and analyzed the information submitted in the extension request by BCS 

(Bayer 2012) and has concluded that Event T303-3 is similar to the antecedent organism, event 

T304-40 and therefore, based on its Plant Pest Risk Assessment for TwinLinkTM cotton (USDAAPHIS 2010) APHIS has concluded that Event T303-3 is unlikely to pose a plant pest risk (see 

Appendix A). The comparison of characteristics of Event T303-3 to the antecedent organism, 

event T304-40, indicates that Event T303-3 expresses the same Cry1Ab and PAT/bar proteins as 

event T304-40; Event T303-3 expresses the same resistance to lepidopteran pests and glufosinate 

ammonium herbicide tolerance as TwinLinkTM Cotton; and Event T303-3 does not exhibit any 

additional traits beyond what is expressed in TwinLinkTM Cotton. Therefore, the proposed action 

identified in the existing NEP A documentation completed for TwinLinkTM Cotton is being used 

to evaluate APHIS' action associated with a determination ofnonregulated status ofEvent T303-

3. 

Based on the similarity to the antecedent organism event T304-40, APHIS has concluded that all 

the alternatives identified in the TwinLinkTM Cotton EA to be relevant to APHIS' regulatory 

actions associated with Event T303-3 and therefore are being used in their entirety. APHIS is 

not aware of any new alternatives that are relevant to APHIS' decision on the regulatory status of 

Event T303-3 that were not considered in the previous NEPA analysis for TwinLinkTM Cotton. 

Therefore, APHIS is using the same alternatives, including the proposed action, identified and 

analyzed in the existing NEP A documentation completed for TwinLinkTM Cotton to evaluate and 

determine ifthere are any potentially significant impacts to the human environment from a 

determination ofnonregulated status ofEvent T303-3. 

Alternatives described in existing TwinLinkTM Cotton EA 

The EA analyzes the potential environmental consequences of a determination of nonregulated 

status ofTwinLinkTM Cotton. To respond favorably to a petition for nonregulated status, APHIS 

must determine that TwinLinkTM Cotton is unlikely to pose a plant pest risk. Based on its Plant 

Pest Risk Assessment (USDA-APHIS 2010) APHIS has concluded that TwinLinkTM Cotton is 

unlikely to pose a plant pest risk. Therefore, APHIS must determine that TwinLinkTM Cotton is 

no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two 

alternatives were evaluated in the EA: (1) no action and (2) determination ofnonregulated status 

of TwinLinkTM Cotton. APHIS has assessed the potential for environmental impacts for each 

alternative in the "Environmental Consequences" section of the EA. 

No Action: Continuation as a Regulated Article 

9 
Under the No Action Alternative, APHIS would deny the petition. TwinLinkTM Cotton and 

progeny derived from TwinLinkTM Cotton would continue to be regulated articles under the 

regulations at 7 CPR Part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions ofTwinLinkTM Cotton and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS might choose this 

alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation ofTwinLinkTM Cotton. 

This alternative is not the Preferred Alternative because APHIS has concluded through a Plant 

Pest Risk Assessment (USDA-APHIS 2010) that TwinLinkTM Cotton is unlikely to pose aplant 

pest risk. Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated status. 

Preferred Alternative: Determination that TwinLinkTM Cotton is No Longer a Regulated Article 

Under this alternative, TwinLinkTM Cotton and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR Part 340. TwinLinkTM Cotton is unlikely to 

pose a plant pest risk (USDA-APHIS 2010). Permits issued or notifications acknowledged by 

APHIS would no longer be required for introductions ofTwinLinkTM Cotton and progeny 

derived from this event. This alternative best meets the agency's purpose and need to respond 

appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 

and the agency's authority under the plant pest provisions of the Plant Protection Act. Because 

the agency has concluded that TwinLinkTM Cotton is unlikely to pose a plant pest risk, a 

determination ofnonregulated status ofTwinLinkTM Cotton is a response that is consistent with 

the plant pest provisions of the PP A, the regulations codified in 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework. Under this alternative, 

growers may have future access to TwinLinkTM Cotton and progeny derived from this event if 

the developer decides to commercialize TwinLinkTM Cotton. 

Alternatives Considered but Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for TwinLinkTM Cotton. The 

agency evaluated these alternatives, in light of the agency's authority under the plant pest 

provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to 

environmental safety, efficacy, and practicality to identify which alternatives would be further 

considered for TwinLinkTM Cotton. Based on this evaluation, APHIS rejected several 

alternatives. These alternatives are discussed briefly below along with the specific reasons for 

rejecting each. · 

Prohibit any TwinLinkTM Cotton from being released 

In response to public comments that stated a preference that no GE organisms enter the 

marketplace, APHIS considered prohibiting the release of TwinLinkTM Cotton, including 

denying any permits associated with the field testing. APHIS determined that this alternative is 

not appropriate given that APHIS has concluded that TwinLinkTM Cotton is unlikely to pose a 

plant pest risk (USDA-APHIS 2010). 

In enacting the Plant Protection Act, Congress found that 

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[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under [the Plant Protection Act] shall be based on sound science ... § 402(4). 

On March 11, 2011, in a Memorandum for the Heads ofExecutive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

implementation of policies for oversight of emerging technologies (such as genetic engineering) 

at the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563 and, consistent with that Executive Order, the following principle, among others, to 

the extent permitted by law, when regulating emerging technologies: 

"[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandates 

of each agency'' 

Based on our Plant Pest Risk Assessment (USDA-APHIS 2010) and the scientific data 

evaluated therein, APHIS has concluded that TwinLinkTM Cotton is unlikely to pose a plant pest 

risk. Accordingly, there is no basis in science for prohibiting the release of TwinLinkTM Cotton. 

Approve the petition in part 

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole 

or in part." For example, a determination ofnomegulated status in part may be appropriate if 

there is a plant pest risk associated with some, but not all lines described in a petition. Because 

APHIS has concluded that TwinLinkTM Cotton is unlikely to pose a plant pest risk, there is no 

regulatory basis under the plant pest provisions of the Plant Protection Act for considering 

approval of the petition only in part. 

Isolation distance between TwinLinkTM Cotton and non-GE cotton and geographical 

restrictions 

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating TwinLinkTM Cotton from non-GE.cotton 

production. However, because APHIS has concluded that TwinLinkTM Cotton is unlikely to 

pose a plant pest risk (USDA-APHIS 201 0), an alternative based on requiring isolation 

distances would be inconsistent with the statutory authority under the plant pest provisions of the 

Plant Protection Act and regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production of TwinLinkTM Gorton based on 

the location of production of non-GE cotton in organic production systems in response to public 

concerns regarding possible gene movement between GE and non-GE plants. However, as 

presented in APHIS' plant pest risk assessment for TwinLinkTM Cotton, there are no geographic 

differences associated with any identifiable plant pest risks for TwinLinkTM Cotton (USDAAPHIS 2010). This alternative was rejected and not analyzed in detail because APHIS has 

concluded that TwinLinkTM Cotton does not pose a plant pest risk, and will not exhibit a greater 

plant pest risk in any geographically restricted area. Therefore, such an alternative would not be 

consistent with APHIS' statutory authority under the plant pest provisions of the Plant Protection 

Act and regulations in Part 340 and the biotechnology regulatory policies embodied in the 

Coordinated Framework. 

11 
Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status 

based on the requirements in 7 CFR part 340 and the agency's authority under the plant pest 

provisions of the Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. 

However, individuals might choose on their own to geographically isolate their non-GE cotton 

productions systems. from TwinLinkTM Cotton or to use isolation distances and other 

management practices to minimize gene movement between cotton fields. 

Requirement of Testing For TwinLinkTM Cotton 

During the comment periods for other petitions for nonregulated status, some commenters 

requested USDA to require and provide testing to identify GE products in non-GE production 

systems. APHIS notes there are no nationally-established regulations involving testing, 

criteria, or limits of GE material in non-GE systems. Such a requirement would be extremely 

difficult to implement and maintain. Additionally, because TwinLinkTM Cotton does not pose a 

plant pest risk (USDA-APHIS 2010), the imposition of any type of testing requirements is 

inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR 

part 340 and the biotechnology regulatory policies embodied in the Coordinated Framework. 

Therefore, imposing such a requirement for TwinLinkTM Cotton would not meet APHIS' 

purpose and need to respond appropriately to the petition in accordance with its regulatory 

authorities. 

Environmental Consequences of APHIS' Selected Action 

Based on the similarity of the antecedent organism event T304-40 to Event T303-3 (see 

Appendix A), APHIS has concluded that the previous analysis of impacts completed for 

TwinLinkTM Cotton to be relevant to APHIS' regulatory actions associated with responding to 

the BCS extension request for Event T303-3. The potential impacts of Event T303-3 on 

agricultural production of cotton, physical environment, animal and plant communities, public 

health, animal feed, socioeconomics, and threatened and endangered species are identical to 

those presented in the Final EA and FONSI for TwinLinkTM Cotton and therefore are being used 

in their entirety to evaluate APHIS' action associated with a determination of nonregulated status 

of Event T303-3. The TwinLinkTM Cotton EA contains a full analysis of the alternatives to 

which we refer the reader for specific details. The following table briefly summarizes the results 

for each of the issues fully analyzed in the Environmental Consequences section of the EA. 

Meets Purpose and Need and Objectives 

,. 

,·, 

' ;·.::(~·\ ""!,,·' <:·<;:. . ~·.:·{::,: ·.. "<> .: .. · . ·_. Altllrnative .A:: No A.C'tion .. 

No 

Unlikely to pose a plant pest risk Satisfied through use of 

regulated field trials 

Management Practices 

Acreage and Areas of Cotton Production Unchanged 

Cropping Practices Unchanged 

Seed Production Unchanged 

Organic Farming Unchanged 

12 

::; . , ·· · A.lternati~~· B: : ' '' 

'>·. net:erinnn~tio~~:()f 

'i .. Norl;~~hla'ted Stitus·. • /. 

Yes 

Satisfied - risk assessment 

(USDA-APHIS 2010) 

Unchanged 

Unchanged 

Unchanged 

Unchanged 
n' .,f~is~r&f·,~~~!lf!1Jrl~i'~r:.'.'·.··c.,~ i~i~~~~~g~;· '"• 

1i·,::\ 

• Attrihl r~~~i.:;;i,;.,,~;;.,·: . ;:•·;·l;Altefnative.N.:r:No ., 0 . ;fiNonie2uia:t~dt$latus······ Specialty Cotton Production Unchanged Unchanged 

Physical Environment 

Water Resources Unchanged Unchanged 

Soil Unchanged Unchanged 

Air Quality Unchanged Unchanged 

Climate Change Unchanged Unchanged 

Animal and Plant Communities 

Animals Unchanged Unchanged 

Plants Unchanged Minimal 

Biological Diversity Unchanged Minimal 

Gene Movement Unchanged Unchanged 

Public Health 

Human Health Unchanged Unchanged 

Worker Safety Unchanged Unchanged 

Animal Feed Unchanged Unchanged 

Socioeconomic Issues 

Domestic Economic Environment Unchanged Unchanged 

Trade Economic Environment Unchanged Unchanged 

Social Environment Unchanged Unchanged 

Other Cumulative Effects Unchanged Unchanged 

Threatened and Endangered Species Unchanged Unchanged 

Other U.S Regulatory Approvals Unchanged for existing FDA consultation complete; 

nonregulated GE organisms EPA biopesticide 

registration complete 

Compliance with Other Laws 

CWW, CAA, EOs Fully compliant Fully compliant 

Unchanged - the current conditions will not change as a result of the selection of this alternative. 

Notes: 

1. 

2. Minimal - the current conditions may change slightly as a result of the selection of this alternative, but the 

changes, if any, are not deemed significant. 

Finding of No Significant Impact 

Based on the analysis of impacts in the existing TwinLinkTM Cotton EA and the similarity of 

Event T303-3 to the antecedent organism event T304-40, a determination ofnonregulated status 

of Event T303-3 will not have a significant impact, individually or cumulatively, on the quality 

of the human environment. I agree with this conclusion and therefore find that an environmental 

impact statement need not be prepared. This NEP A determination is based on the following 

context and intensity factors (40 CFR 1508.27): 

Context- The term "context" recognizes potentially affected resources, as well as the location 

and setting in which the environmental impact would occur. This action has potential to affect 

13 
conventional and organic cotton production systems, including surrounding environments and 

agricultural workers; human food and animal feed production systems; and foreign and domestic 

commodity markets. Most of the cotton acreage in the U.S. is planted to GE cotton. Of the 11.3 

million acres planted in cotton in 2010, 93% (10.5 million acres) were GE cotton. Of this, 73% 

of the GE cotton acreage was GE insect-resistant (Bt) cotton and 78% was herbicide-tolerant 

(USDA-ERS 2010a, 2010b). A determination ofnonregulated status ofEventT303-3 is not 

expected to directly cause an increase in· agricultural acreage devoted to cotton production, or 

those cotton acres devoted to GE cotton cultivation. The availability of Event T303-3 will 

not change cultivation areas for cotton production in the U.S. and there are no anticipated 

changes to the availability of GE and non-GE cotton varieties on the market. 

Although a determination ofnonregulated status ofEvent T303-3 would allow for new 

plantings ofEvent T303-3 to occur anywhere in the U.S., APHIS primarily focused the 

environmental analysis to those geographic areas that currently support cotton production. A 

determination ofnonregulated status of Event T303-3 is not expected to increase cotton 

production, either by its availability alone or accompanied by other factors, or cause an increase 

in overall GE cotton acreage. 

Intensity - Intensity is a measure of the degree or severity of an impact based upon the ten 

factors. The following factors were used as a basis for this decision: 

1. Impacts that may be both beneficial and adverse. 

A determination ofnonregulated status of Event T303-3 will have no significant 

environmental impact in relation to the availability of GE, conventional, organic or 

specialty cotton varieties. Based on the discussions in Chapter 4 of the TwinLinkTM 

Cotton EA and its similarity to the antecedent organism event T304-40, a determination 

ofnonregulated status of Event T303-3 is not expected to directly cause an increase in 

agricultural acreage devoted to cotton production, or those cotton acres devoted to GE 

cotton cultivation. The availability ofEvent T303-3 will not change cultivation areas 

for cotton production in the U.S. and there are no anticipated changes to the availability 

of GE and non-GE cotton varieties on the market. A determination of nonregulated 

status of Event T303-3 could add another GE cotton variety to the conventional cotton 

market and is not expected to change the market demands for GE cotton or cotton 

produced using organic methods or specialty systems. Most of the cotton acreage in the 

U.S. is planted to GE cotton. Of the 11.3 million acres planted in cotton in 2010, 93% 

(10.5 million acres) were GE cotton. Ofthis, 73% ofthe GE cotton acreage was GE 

insect-resistant (Bt) cotton and 78% was herbicide-tolerant (USDA-ERS 2010a, 2010b). 

Based upon recent trend information, adding GE varieties to the market is not related to 

the ability of organic production systems to maintain their market share. Between 

2000 and 2008, although 12 GE cotton events or lines were no longer subject to the 

plant pest provisions of the Plant Protection Act and 7 CFR part 340, the acreage 

associated with the organic production of cotton remained at slightly above 15,000 acres 

(USDA-ERS 2010c). Based on the data provided by BCS on the antecedent organism 

T304-40 cotton (Bayer 2010), as well as previous experience with other Bt cotton 

varieties that have been widely adopted by growers since their introduction in 1996 

(USDA-ERS 2010a), APHIS has concluded that the availability ofEvent T303-3 would· 

14 
not alter the agronomic practices, locations, and seed production and quality 

characteristics of conventional and GE seed production. A determination of nonregulated 

status of Event T303-3 will not require a change to seed production practices. A 

determination ofnonregulated status of Event T303-3 is not expected to result in 

changes in the current cotton cropping practices. As discussed in Chapter 4 of the 

TwinLinkTM Cotton EA, studies demonstrate the antecedent organism T304-40 cotton is 

essentially indistinguishable from other cotton varieties used in terms of agronomic 

characteristics and cultivation practices (Bayer 2010). IfEvent T303-3 is adopted, a 

continued reduction in the use ofbudwormlbollworm insecticides applications and the 

number of acre-treatments per year as reported in Benbrook's trend analysis (Benbrook 

2009) is expected to occur. A determination ofnonregulated status of Event T303-3 will 

provide growers with another alternative Bt cotton variety to cultivate. Herbicide use 

patterns have the potential to change as well. The introduction of Event T303-3 provides 

a cotton variety, expressing Bt-based lepidopteran resistance combined with tolerance to 

glufosinate ammonium, an alternative herbicide. Event T3030-3 provides growers with 

an alternative to those cotton varieties resistant to glyphosate, thus expanding options in 

the field for weed control. In those fields where glyphosate-resistant weeds have 

emerged, glufosinate ammonium tolerance provides the grower with an option to 

transition away from glyphosate herbicides to a different post-emergent herbicide. The 

transition to glufosinate ammonium could reduce applications of those other herbicides 

needed to manage glyphosate-resistant weeds. 

2. The degree to which the proposed action affects public health or safety. 

A determination ofnonregulated status ofEverit T303-3 would have no significant 

impacts on human or animal health. As discussed in Chapter 4 of the TwinLinkTM 

Cotton EA, similar products were no longer subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR part 340 beginning in 1996 with the introduction of Bt 

products and followed shortly after by the introduction of the various "Liberty" products 

which provided tolerance to glufosinate ammonium. In each case, FDA and EPA 

reviews and approvals determined that the products met the agency's review criteria for 

approval. The cultivation of these existing crop products would not change under either 

alternative. Both characteristics have been successfully cultivated in multiple crops in 

the ensuing years with no evidence of human health impacts. BCS provided the FDA 

with information on the identity, function, and characterization of the genes, for 

TwinLinkTM Cotton, including expression of the gene products. FDA evaluated BCS 

submission to determine whether the developer's product raises any safety or regulatory 

issues with respect to the intended modification or with respect to the food itself. Based 

on the information provided by BCS and other information available to the agency, FDA 

did not identify any safety or regulatory issues under the Federal Food, Drug and 

Cosmetic Act or current FDA regulations that would require further evaluation at this 

time (US-FDA 2011 ). BCS applied for EPA pesticide registrations of Cry1Ab and 

Cry2Ae proteins as expressed in Events T304-40 and GHB119 cotton, respectively, and a 

new combination PIP product, TwinLinkTM cotton, created through conventional 

breeding of these events for use as PIPs in 2009, under section 3 ofthe FIFRA. BCS 

concurrently filed a petition for a permanent exemption from the requirement of a 

tolerance for Cry2Ae protein residues in or on food and feed commodities in cotton. 

EPA believes that, based upon its assessment of the data and information submitted by 

15 
BCS, it is in the interest of the public and the environment to issue the registrations 

proposed by BCS (US-EPA 2012). Based on the analysis of field and laboratory data and 

scientific literature provided by BCS on TwinLinkTM Cotton (Bayer 2010); the safety 

data available on other GE cotton; FDA' conclusions on the TwinLinkTM Cotton; EPA' 

registration of Cry lAb and Cry2Ae proteins as expressed in Events T304-40 and 

GHB 119 cotton, respectively, and a new combination PIP product, TwinLinkTM cotton; 

and its similarity to the antecedent organism event T304-40, APHIS has concluded that a 

determination ofnonregulated status ofEvent T303-3 would have no adverse impacts on 

human or animal health. · 

3. Unique characteristics of the geographic area such as proximity to historic or cultural 

resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically 

critical areas. 

There are no unique characteristics of geographic areas such as park lands, prime farm 

lands, wetlands, wild and scenic areas, or ecologically critical areas that would be 

adversely impacted by a determination ofnonregulated status ofEvent T303-3. Similar 

to the antecedent organism T304-40, the common agricultural practices that would be 

carried out under the proposed action will not cause major ground disturbance; do not 

cause any physical destruction or damage to property; do not cause any alterations of 

property, wildlife habitat, or landscapes; and do not involve the sale, lease, or transfer of 

ownership of any property. This action is limited to a determination of nonregulated 

status of Event T303-3. Similar to the antecedent organism T304-40, the product will be 

deployed on agricultural land currently suitab'Ie for production of cotton and is not 

expected to increase the acreage of cotton production. This action would not convert 

land use to nonagricultural use and therefore would have no adverse impact on prime 

farm land. Standard agricultural practices for land preparation, planting, irrigation, and 

harvesting of plants would be used on agricultural lands planted to Event T303-3, 

including the use of EPA registered pesticides. Applicant's adherence to EPA label use 

restrictions for all pesticides will mitigate potential impacts to the human environment. 

In the event of a determination ofnonregulated status of Event T303-3, the action is not 

likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild 

and scenic rivers, or ecologically critical areas that may be in close proximity to cotton 

production sites. 

4. The degree to which the effects on the quality of the human environment are likely to be 

highly controversial. 

The effects on the quality of the human environment from a determination of 

nonregulated status of Event T303-3 are not highly controversial. Although there is some 

opposition to a determination ofnonregulated status ofEvent T303-3, this action is not 

highly controversial in terms of size, nature or effect on the natural or physical 

environment. Based on the discussions in Chapter 4 of the TwinLinkTM Cotton EA and 

its similarity to the antecedent organism event T304-40, a determination of nonregulated 

status of Event T303-3 is not expected to directly cause an increase in agricultural 

acreage devoted to cotton production, or those cotton acres devoted to GE cotton 

cultivation. The availability of Event T303-3 will not change cultivation areas for 

cotton production in the U.S. and there are no anticipated changes to the availability of 

GE and non-GE cotton varieties on the market. Similar to the antecedent organism T304-

40, Event T303-3 is not expected to increase the total acreage of cotton production or 

16 
current cotton cropping practices. It is anticipated that the trend of reduced broadspectrum insecticide use by cotton growers will continue due to the adoption ofBt cotton 

and other cultural practices. There is the potential that the introduction of glufosinate 

ammonium tolerance may result in a reduction in total herbicide use as growers adopt 

different herbicide treatment strategies involving glufosinate ammonium as a postemergent crop treatment, thereby reducing the use of some of the other herbicides which 

have been required in response to the emergence of glyphosate-resistant weeds. Similar 

to the antecedent organism T304-40, the effect ofEvent T303-3 on wildlife or 

biodiversity is no different than that of other GE or non-GE cotton produced in 

conventional agriculture in the U.S. Although Event T303-3 does provide the grower 

with a new choice for a herbicide-tolerant and insect-resistant variety, based on the 

similarity to the antecedent organism T304-40, cultivation of Event T303-3 does not 

otherwise require a change in the rates of fertilizer application, tillage, planting, or 

harvesting from existing commercial cotton varieties, including other GE cotton varieties 

providing either insect resistance, herbicide tolerance, or stacked with both (Bayer 2010). 

During the public comment period for TwinLinkTM Cotton, APHIS received comments 

opposing a determination ofnonregulated status ofTwinLinkTM Cotton. No new issues, 

alternatives or substantive new information were identified in any of the comments 

received by APHIS. These individuals did not mention their specific disagreement with 

APHIS' analyses ofTwinLinkTM Cotton detailed in the EA or the PPRA (USDA-APHIS 

2010); rather, they expressed their general opposition to genetically modified organisms 

(GMOs) or GE crops. Other claims suggest a negative impact of GE cotton and GE 

plants on human health and environmental safety in a general nature. Overall, people 

who expressed their opposition to a determination of nonregulated status did not provide 

any supporting evidence for their claims. APHIS has not received any additional 

information or comments from the public specifically directed at the TwinLinkTM Cotton 

petition, PPRA or NEP A documentation since a determination of non-regulated status 

was announced on October 12, 2011 (76 FR 63278-63279). 

5. The degree to which the possible effects on the human environment are highly uncertain 

or involve unique or unknown risks. 

Based on the analysis documented in the TwinLinkTM Cotton EA and its similarity to the 

antecedent organism event T304-40, the possible effects on the human environment from 

a determination ofnonregulated status ofEvent T303-3 are well understood. The effects 

of the proposed activities are not highly uncertain and do not involve unique or unknown 

risks on the natural or physical environment. Based on the discussions in Chapter 4 of 

the TwinLinkTM Cotton EA and its similarity to the antecedent organism event T304-40, 

a determination ofnonregulated status ofEvent T303-3 is not expected to directly cause 

an increase in agricultural acreage devoted to cotton production, or those cotton acres 

devoted to GE cotton cultivation. Similar to the antecedent organism T304-40, a 

determination ofnonregulated status of Event T303-3 is not expected to result in 

changes in the current cotton cropping practices. BCS' studies demonstrate 

TwinLinkTM Cotton is essentially indistinguishable from other cotton varieties used in 

terms of agronomic characteristics and cultivation practices (Bayer 2010; USDA-APHIS 

2010). Although Event T303-3 does provide the grower with a new choice for a 

herbicide-tolerant and insect-resistant variety, based on the similarity to the antecedent 

organism T304-40, the cultivation of Event T303-3 does not otherwise require a change 

17 
in the rates of fertilizer application, tillage, planting, or harvesting from existing 

commercial cotton varieties, including other GE cotton varieties providing either insect 

resistance, herbicide tolerance, or stacked with both (Bayer 2010). It is anticipated that 

the trend of reduced broad-spectrum insecticide use by cotton growers will continue due 

to the adoption ofBt cotton and other cultural practices. There is the potential that the 

introduction of glufosinate ammonium tolerance may result in a reduction in total 

herbicide use as growers adopt different herbicide treatment strategies involving 

glufosinate ammonium as a post-emergent crop treatment, thereby reducing the use of 

some of the other herbicides which have been required in response to the emergence of 

glyphosate-resistant weeds. Similar to the antecedent organism T304-40, the effect of 

Event T303-3 on wildlife or biodiversity is no different than that of other GE or non-GE 

cotton produced in conventional agriculture in the U.S. As described in Chapter 4 of the 

TwinLinkTM Cotton EA, well established management practices, production controls, and 

production practices (GE, conventional, and organic) are currently being used in cotton 

production systems (commercial and seed production) in the U.S. Therefore, it is 

reasonable to assume that farmers, who produce conventional cotton (GE and non-GE 

varieties), Event T303-3, or produce cotton using organic methods or specialty systems, 

will continue to use these reasonable, commonly accepted best management practices for 

their chosen systems and varieties during agricultural cotton production. Additionally, 

most of the cotton acreage in theU.S. is planted to GE cotton. Of the 11.3 million acres 

planted in cotton in 2010, 93% (10.5 million acres) were GE cotton. Ofthis, 73% ofthe 

GE cotton acreage was GE insect-resistant (Bt) cotton and 78% was herbicide-tolerant 

(USDA-ERS 2010a, 2010b). Based upon historic trends, conventional production 

practices that use GE varieties will likely continue to dominate in terms of acreage with 

or without a determination ofnonregulated status of Event T303-3. Given the extensive 

experience that APHIS, stakeholders, and growers have in dealing with the use of GE 

cotton products, the possible effects to the human environment from the release of a an 

additional GE cotton product are already well known and understood. Therefore the 

impacts are not highly uncertain, and do not involve unique or unknown risks. 

6. The degree to which the action may establish a precedent for future actions with 

significant effects or represents a decision in principle about a future consideration. 

A determination ofnonregulated status ofEvent T303-3 would not establish a precedent 

for future actions with significant effects or represent a decision in principle about a 

future decision. Similar to past regulatory requests reviewed and approved by APHIS, a 

determination of nonregulated status will be based upon an independent determination on 

whether an organism is unlikely to pose a plant pest risk pursuant to the regulatory 

requirements of 7 CPR part 340. Each petition that APHIS receives is specific to a 

particular GE organism and undergoes this independent review to determine if the 

regulated article poses a plant pest risk. Under the authority of the plant pest provisions 

of the Plant Protection Act and 7 CPR part 340, APHIS has issued regulations for the safe 

development and use of GE organisms. As required by 7 CPR 340.6, APHIS must 

respond to petitioners who request a determination of the regulated status of GE 

organisms, including GE plants such as Event T303-3. When a request for an extension 

ofnonregulated status is submitted, APHIS must make a determination if the GE 

organism is similar to an antecedent organism which has previously been determined to 

be unlikely to pose a plant pest risk. If APHIS determines based on its Plant Pest Risk 

18 
Assessment of the antecedent organism that the genetically engineered organism 

identified in the extension request is unlikely to pose a plant pest risk, the genetically 

engineered organism is no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340. APHIS regulations at 7 CPR part 340, which were 

promulgated pursuant to authority granted by the Plant Protection Act, as amended (7 

United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, 

interstate movement, or release into the environment) of certain GE organisms and 

products. A GE organism is considered a regulated article if the donor organism, 

recipient organism, vector, or vector agent used in engineering the organism belongs to 

one of the taxa listed in the regulation (7 CPR 340.2) and is also considered a plant pest. 

A GE organism is also regulated under Part 340 when APHIS has reason to believe that 

the GE organism may be a plant pest or APHIS does not have information to determine if 

the GE organism is unlikely to pose a plant pest risk. A person may petition the agency 

that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no 

longer regulated under the plant pest provisions of the Plant Protection Act or the 

regulations at 7 CPR 340. The petitioner is required to provide information under§ 

340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified 

organism. A person may also request that APHIS extend a determination of nonregulated 

status to other organisms under§ 340.6(e)(2). Such a request shall include information to 

establish the similarity of the antecedent organism and the regulated articles in question. 

A GE organism is no longer subject to the regulatory requirements of 7 CPR part 340 or 

the plant pest provisions of the Plant Protection Act when APHIS determines that it is 

unlikely to pose a plant pest risk. 

7. Whether the action is related to other actions with individually insignificant but 

cumulatively significant impacts. 

Based on the similarity of the antecedent organism T304-40 to Event T303-3, no 

significant cumulative effects were identified through this assessment. The TwinLinkTM 

Cotton EA discussed cumulative effects on cotton management practices, human and 

animal health, and the environment and concluded that such impacts were not significant. 

A cumulative effects analysis is included for each environmental issue analyzed in 

Chapter 4 of the TwinLinkTM CottoJ;I EA. In the event of a determination of 

nomegulated status, similar to the antecedent organism T304-40, Event T303-3 may be 

stacked (combined) with non-GE and GE cotton varieties by traditional breeding 

techniques, resulting in a plant that, for example, may also be resistant to other 

herbicides, or may present a different combination of insect pest-resistant, but may also 

have progeny with no transgenes at all. Similar to the antecedent organism T304-40, 

there is no guarantee that Event T303-3 will be stacked with any particular non-GE or GE 

cotton varieties that are no longer subject to the plant pest provisions ofthe Plant 

Protection Act and 7 CPR part 340, as company plans and market demands play a 

significant role in those business decisions. Thus, predicting all potential combinations 

of stacked varieties that could be created using both non-GE and GE cotton varieties that 

are no longer subject to the plant pest provisions of the Plant Protection Act and 7 CPR 

part 340 is hypothetical and purely speculative. Based on the analysis documented in the 

TwinLinkTM Cotton EA and its similarity to the antecedent organism event T304-40, in 

the event of a determination ofnonregulated status ofEvent T303-3, APHIS has not 

19 
identified any significant impact on the environment which may result from the 

incremental impact of a determination o_fnonregulated status of Event T303-3 when 

added to other past, present, and reasonably foreseeable future actions. 

8. The degree to which the action may adversely affect districts, sites, highways, structures, 

or objects listed in or eligible for listing in the National Register of Historic Places or 

may cause loss or destruction of significant scientific, cultural, or historical resources. 

Based on the analysis documented in the TwinLinkTM Cotton EA and its similarity to the 

antecedent organism event T304-40, a determination ofnonregulated status of Event 

T303-3 is not expected to adversely impact cultural resources on tribal properties. Any 

farming activities that may be taken by farmers on tribal lands are only conducted at the 

tribe's request; thus, the tribes have control over any potential conflict with cultural 

resources on tribal properties. Similar to the antecedent organism T304-40, a 

determination of nonregulated status of Event T303-3 would have no impact on districts, 

sites, highways, structures, or objects listed in or eligible for listing in the National 

Register of Historic Places, nor would they likely cause any loss or destruction of 

significant scientific, cultural, or historical resources. This action is limited to a 

determination ofnonregulated status of Event T303-3. Similar to the antecedent 

organism T304-40, standard agricultural practices for land preparation, planting, 

irrigation, and harvesting of plants would be used on agricultural lands planted to Event 

T303-3, including the use ofEPA registered pesticides. Applicant's adherence to EPA 

label use restrictions for all pesticides will mitigate potential impacts to the human 

environment. A determination ofnonregulated status ofEvent T303-3 is not an 

undertaking that may directly or indirectly cause alteration in the character or use of 

historic properties protected under the National Historic Preservation Act. In general, 

common agricultural activities conducted under this action do not have the potential to 

introduce visual, atmospheric, or audible elements to areas in which they are used that 

could result in effects on the character or use of historic properties. For example, there is 

potential for audible effects on the use and enjoyment of a historic property when 

common agricultural practices, such as the operation of tractors and other mechanical 

equipment, are conducted close to such sites. A built-in mitigating factor for this issue is 

that virtually all of the methods involved would only have temporary effects on the 

audible nature of a site and can be ended at any time to restore the audible qualities of 

such sites to their original condition with no further adverse effects. Additionally, these 

cultivation practices are already being conducted throughout the cotton production 

regions. The cultivation of Event T303-3 does not inherently change any of these 

agronomic practices so as to give rise to an impact under the NHP A. 

9. The degree to which the action may adversely affect an endangered or threatened species 

or its habitat that has been determined to be critical under the Endangered Species Act of 

1973. 

As described in Chapter 4 of the TwinLinkTM Cotton EA, APHIS has analyzed the 

potential for effects from a determination ofnonregulated status ofTwinLinkTM Cotton 

on federally listed threatened and endangered species (TES) and species proposed for 

listing, as well as designated critical habitat and habitat proposed for designation, as 

required under Section 7 of the Endangered Species Act. APHIS has obtained and 

reviewed the USFWS list of Threatened and Endangered Species 

(http:/ I ecos.fws. gov /tess public/S tateList:ing.do ?state= vVV &status= listed) and based on 

20 
the analysis documented in the TwinLinkTM Cotton EA and its similarity to the 

antecedent organism event T304-40, APHIS has reached a conclusion that a 

determination ofnomegulated status of Event T303-3 would have no effect on 

federally listed threatened or endangered species and species proposed for listing, or on 

designated critical habitat or habitat proposed for designation. 

I 0. Whether the action threatens a violation of Federal, State, or local law or requirements 

imposed for the protection of the environment. 

The proposed action, a determination ofnonregulated status of Event T303-3, would be 

in compliance with all federal, state, and local laws. Because the agency has concluded 

that Event T303-3 is unlikely to pose a plant pest risk, a determination of nonregulated 

status ofEvent T303-3 is a response that is consistent with the plant pest provisions of the 

PP A, the regulations codified in 7 CFR part 340, and the biotechnology regulatory 

policies in the Coordinated Framework. Similar to the antecedent organism event T304-

40, Event T303-3 is within the scope of the 1992 FDA policy statement concerning 

regulation of products derived from new plant varieties, including those developed 

through biotechnology (US-FDA 1992). EPA has authority over the use of pesticidal 

substances and plant-incorporated protectants under the FIFRA as amended (7 USC 

§ 136, et seq.) and the FFDCA (21 USC §301, et seq.). There are no other Federal, state, 

or local permits that are needed prior to the implementation of this action. 

NEP A Decision and Rationale 

I have carefully reviewed the existing NEP A documentation completed for TwinLinkTM Cotton, 

including input from the public involvement process. Based on APHIS' conclusion that Event 

T303-3 encompasses the same scope of environmental analysis and regulatory decision as 

TwinLinkTM Cotton; that is a determination of nonregulated status under 7 CFR part 340, I 

believe the issues identified and analyzed in the existing NEP A documentation for TwinLinkTM 

Cotton are relevant to this regulatory action and best addressed by extending a determination of 

nonregulated status to Event T303-3. This regulatory action meets APHIS' purpose and need to 

allow the safe development and use of genetically engineered organisms consistent with the plant 

pest provisions of the Plant Protection Act. 

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the 

agency believes would fulfill its statutory mission and responsibilities, giving consideration to 

economic, environmental, technical and other factors." A determination of nonregulated status 

of Event T3030-3 has been selected for implementation based on consideration of a number of 

environmental, regulatory, and social factors. Based upon our evaluation and analysis, a 

determination ofnonregulated status ofEvent T3030-3 is selected because (1) it allows APHIS 

to fulfill its statutory mission to protect America's agriculture and environment using a sciencebased regulatory framework that allows for the safe development and use of genetically 

engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS 

has not identified any plant pest risks associated with Event T303-3, the continued regulated 

status of Event T303-3 would be inconsistent with the plant pest provisions of the PPA, the 

regulations codified at 7 CFR part 340, and the biotechnology regulatory policies in the 

Coordinated Framework. For the reasons stated above, I have determined that a determination of 

nonregulated status ofEvent T303-3 will not have any significant environmental effects. 

21 
Michael C. Gregoire 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Services 

U.S. Department of Agriculture 

Literature Cited: 

Date: 

BCS (20 1 0). Ignite® 280 SL Herbicide Label Bayer Crop Science. Retrieved January 2, 2011 

from http://fsl.agrian.com/pdfs/Ignite 280 SL Herbicide Label3.pdf 

Bayer (2010). Petition for Determination ofNonregulated Status for Insect-Resistant and 

Glufosinate Ammonium-Tolerant Cotton: TwinLinkTM Cotton (Events T304-40 x 

GHB119). Submitted by AL Scott, Regulatory Affairs Manager. Bayer CropScience LP 

(See Table http://\v\vvv.aphis.usda.gov/biotechnologv/not reg.html). 

Bayer (2012). Application for an Extension of the Determination ofNonregulated Status for 

Insect-Resistant, Glufosinate Ammonium-Tolerant Cotton (08-340-01p): Transformation 

Event T303-3. Submitted by Michael Weeks, M.S., U.S. Registration and Compliance 

Specilaist. Regulatory Affarirs. Bayer CropScience (See Table 

http://vvww.aphis.usda.gov/bioteclmologv/not reg.html). 

Benbrook, C. (2009). Impacts of Genetically Engineered Crops on Pesticide Use in the United 

States: The First Thirteen Years, The Organic Center: 69. 

US-EPA (2010a) Bacillus thuringiensis Cry1Ab Protein in all Plants; Exemption from the 

Requin~ment of a Tolerance, 40 CFR §174.511. 

US-EPA (2010b) Bacillus thuringiensis Cry2Ae Protein in Cotton; Temporary Exemption from 

the Requirement of a Tolerance, 40 CFR § 17 4.530 

US-EPA. (20 1 Oc) Phosphinothricin Acetyltransferase (PAT): Exemption from the Requirement 

ofTolerance. 40 CFR §174.522, first published at 40 CFR §180.1151. 

US-EPA. (2012) Biopesticide Registration Action Document: Plant-incorported protectants: 

Bacillus thuringiensis CrylAb protein and the Genetic Material Necessary for its 

Production in Event T304-40 Cotton [PC Code 006525, OECD Unique Identifier: BCSGH004-7]; Bacillus thuringiensis Cry2Ae protein and the Genetic Material Necessary 

22 
for its Production in Event GHB119 Cotton [PC Code 006600, OECD Unique Identifier: 

BCS-GH005-8]; andTwinLinkTM Cotton (T304-40 and GHB119 Combination PIP 

product)[OECD Unique Identifier: BCS-GH004-7 x BCS-GH005-8]. U.S. 

Environmental Protection Agency, Office of Pesticide Programs, Biopesticides and 

Pollution Prevention Division. January 26, 2012. 

http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2011-0988 

US-FDA (1992). Statement of Policy- Foods Derived from New Plant Varieties. Retrieved 

January 18, 2011 from 

http:/ /w.,vw .fda. gov IF ood/GuidanceComp lianceRe gulatorylnformation/ GuidanceDocume 

nts/Biotechnology/ucm096095 .htm 

US-FDA (2011). Biotechnology Consultation Note to the File BNF No. 000118. 

http:/ /w-ww.fda.gov/F ood!Bioteclmology/S ubmissions/ucm2713 78.htm 

USDA-APHIS (2010) Determination of Plant Pest Risk for Insect-Resistant and Glufosinate 

Ammonium-Tolerant (TwinLinkTM) Cotton, Gossypium hirsutum, events T304-40 x 

GHB119. Retrieved from http://wwvv.aphis.usda.gov/biotechnology/not reg.html 

USDA-ERS (2010a). Adoption of Genetically Engineered Crops in the U.S. Economic Research 

Service. Retrieved November 2, 2010 from http://www.ers.usda.gov/data!BiotechCrops/ 

USDA-ERS (201Gb). Adoption of Genetically Engineered Crops in the U.S.: Upland Cotton 

Varieties Economic Research Service. Retrieved December 3, 2010 from 

http://www .ers. usda. gov/Data!BiotechCrops/ExtentofAdoption Table2.htm 

USDA-ERS (2010c). Table 3--Certified Organic and Total U.S. Acreage, Selected Crops and 

Livestock, 1995-2008 Economic Research Service. Retrieved November 5, 2010 from 

http://vV\vw.ers.usda.gov/Data/Organic/ 

USDA-NASS (2007). 2007 Census of Agriculture: Cotton Industry Retrieved November 5, 

2010 from 

http://www .agcensus. usda.gov/Publications/2007 /Online Highlights/Fact Sheets/cotton. 

pill 

USDA-NASS (2010). 2010 Upland Cotton Harvested Areas National Agriculture Statistics 

Service Board. Retrieved November2, 2010 from 

http://www.nass.usda.gov/Charts and Maps/graphics/cotnacm.pdf 

23 
Appendix A. Similarity of Cotton Event T303-3 to the Antecedent Organism T304-40 

APHIS-BRS has received an extension request (APHIS number 12-033-0lp) from Bayer 

CropScience for noruegulated status of genetically engineered (GE) cotton event T303-3. The 

extension request refers to Bayer TwinLinkTM cotton as the comparator or antecedent organism. 

GE cotton event T304-40 is one ofthe parents ofBayer CropScience TwinLinkTM cotton, which 

was submitted for nomegulated status December 22, 2008 (APHIS petition number 08-340-01 p) 

and received a determination of non-regulated status from APHIS on October 12, 2011 (76 FR 

63278-63279). A comparison of a variety of characteristics ofT303-3 and T304-40 cottons 

follow this text. 

Functionally, the two cotton varieties are resistant to the identical types of pests as well as the 

same herbicide. They are similar in that they both express a Cry lAb protein from Bacillus 

thuringiensis and a phosphinothricin acetyltransferase (PAT) protein from Streptomyces 

hygroscopicus. The primary difference between these two cotton varieties is the presence of a 

Ps7s7 subterranean clover stunt virus promoter in T304-40 versus a P35S2 cauliflower mosaic 

virus promoter in T303-3. Both promoters drive expression of the CrylAb gene in their 

respective varieties, and the difference in promoters does not change the similarity in the proteins 

produced between the two varieties. Because the Cry lAb and PAT proteins are similar between 

the two varieties, the protein in T303-3 cotton will not be substantively different than that found 

in T304-40. 

Disease and pest susceptibility: Similar to results from field trials with TwinLinkTM 

cotton, no significant differences were noted in diseases·or pests between GE T303-3 

lines and the appropriate comparator lines over several years of trials (Bayer 

CropScience, 2012, Section VII.C. and Appendix 1, pp 57-86). 

Outcrossing to wild relatives: Similar to observations made on TwinLinkTM cotton, the 

T303-3 line produces heavy, sticky pollen and is considered to be primarily selfpollinating. As such, outcrossing to other cotton ( Gossypium hirsutum, G. tomentosum, 

G. barbadense, G. thurberi) can be expected to be the same (Bayer CropScience, 2012, 

Section VIII.A., p. 49). 

Weediness potential: Similar to phenotypic observations made on TwinLinkTM cotton, 

observations and data collected for T303-3 did not indicate any increased potential for 

T303-3 to become a weed (Bayer CropScience, 2012, Sections VII.B. and VI.B.l., pp 41-

45; Section VIII.B., p. 50). Relevant data collected related to plant emergence, height, 

number of nodes, seed production, etc). 

Nontarget or beneficial organisms: The functional proteins produced in TwinLinkTM 

cotton and T303-3 (CrylAb and PAT) are identical. As such, it can be anticipated that 

potential impacts on nontarget and/or beneficial organisms will be identical. Those 

assessments were conducted by Bayer and noted minimal to no risk to nontarget 

organisms (Bayer 2008, Section IX, pp. 79-85). 

24 
Transfer of genetic material to organisms with which it cannot interbreed: Bayer notes 

nothing significant about either of these plants that would increase the potential for 

horizontal gene transfer (Bayer 2008, p 79: Bayer 2012, p. 49). 

After a thorough review of the BCS extension request, BRS concludes that Event T303-3 is 

similar to the antecedent organism, event T304-40 and therefore, the plant pest risk assessment 

developed for TwinLinkTM cotton (USDA-APHIS 2010) will be used to determine ifEvent 

T303-3 is unlikely to pose a plant pest risk. Similar to the conclusions found in the plant pest 

risk assessment for TwinLinkTM cotton (USDA-APHIS 2010), that is, due to the lack of plant 

pest risk from the inserted genetic material, the lack of weediness characteristics, the lack of 

atypical responses to disease or plant pests in the field, the lack of deleterious effects on nontargets or beneficial organisms in the agro-ecosystem, and the lack of horizontal gene transfer, 

APHIS has concluded that Event T303-3 is unlikely to pose a plant pest risk. 

Literature Cited: 

Bayer CropScience. 2008. Petition for Determination ofNomegulated Status for Insect-Resistant 

and Glufosinate Ammonium-Tolerant cotton: TwinLinkTM cotton (events T304-40 x 

GHB119) 

Bayer CropScience. 2012. Application for an Extension of the Determination ofNomegulated 

Status for Insect-Resistant, Glufosinate Ammonium-Tolerant Cotton (08-340-01p): 

Transformation Event T303-3 

USDA-APHIS. 2010. Determination of Plant Pest Risk for Insect-Resistant and Glufosinate 

Ammonium-Tolerant (TwinLinkTM) Cotton, Gossypium hirsutum, events T304-40 x 

GHB119. Retrieved from http://www.aphis.usda.gov/biotechnology/not_reg.html 

25