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 ofAgriculture Animal and Plant Health Inspection Service Biotechnology Regulatory Services



### The United States Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has developed this decision document to complywith the requirements ofthe National Environmental Policy Act (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing regulations and procedures. This NEPA decision document, a Finding ofNo Significant Impact (FONSI), sets forth APHIS' NEPA decision and its rationale.
Bayer CropScience (BCS) submitted a request to APHIS in February 2012 for an extension ofa determination ofnonregulated status for a genetically engineered (GE) insect-resistant, glufosinate ammonium tolerant cotton event T303-3 (Event T303-3). A person maypetition the agency that a particularregulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions ofthe Plant Protection Act or the regulations at 7 CFR 340. A person mayrequest that APHIS extend a determination ofnonregulated status to other organisms under§ 340.6(e)(2) ofthe regulations. Such arequest shall include information to establish the similarity ofthe 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 ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plant pestrisk. APHIS reviewed and analyzed the information submitted in the extension request byBCS (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 ofnon-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. Bycrossing BCS' Cry1Ab Cotton (event T304-40) with BCS' Cry2Ae Cotton (event GHB119), BCS has developed a cotton resistant to lepidopteranpests. 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 ofEvent T303-3 with conventional cotton, and any progeny derived from crosses ofEvent T303-3 with other transgenic cotton varieties that have received a

1I '. determination ofnomegulated status, no longerbe considered regulated articles under 7 CFR Part 340. Event T303.:3 is currentlyregulated under 7 CFRpart 340. Interstate movements and field trials ofEvent T303-3 have been conducted underpermits issued ornotifications acknowledgedbyAPHIS since 2001. Dataresulting from these field trials are described in BCS application for extension (Bayer 2012).

In accordance withAPHIS procedures implementingNEPA (7 CFRpart 372), APHIS completed
an Environmental Assessment (EA) and NEPA Decision/FONSI that analyzed the potential impacts to the human environment1 from a determination on the regulated status ofa 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 theproposed action and the alternatives. APHIS has carefully examinedthe existing NEPA documentation completed for TwinLinkTM Cotton and has concluded that the BCS extension request for a determination of nomegulated status ofEvent T303-3 encompasses the same scope ofenvironmental analysis as TwinLinkTM Cotton. This conclusion is based on:

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

• Event T303-3 expresses the sameresistance 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 ofnomegulated status under 7 CFRpart 340;

• the affected environment, issues and alternatives described and analyzed in the existing NEPA documentation for TwinLinkTM Cotton are applicable to the extension request of Event T303-3; · • no new alternatives have beenidentified that are relevant to this regulatory action;

• no substantive new environmental or social issues and impacts have been identifiedthat
are relevant to this regulatory action; and

• APHIS is not aware ofany substantive new information that would warrant alteration of the existingNEP A documentation for TwinLinkTM Cotton, including the proposed action
or analysis ofimpacts in the EA;

Based on its similarityto the antecedent organism event T304-40, the BCS extensionrequest for Event T303-3 has been subject to the previous NEPAreview completed for TwinLinkTM Cotton. Therefore, the existingNEPA documentation completed for TwinLinkTM Cotton is beingusedto evaluate and determine ifthere are anypotentially significant impacts to the human enviroriment from APHIS' response to BCS extensionrequest for a determination.ofnomegulated status of Event T303-3. Regulatory Authority

t UnderNEPA regulations, the "human environment" includes "the natural andphysical environment and the relationship ofpeople with that environment" (40 CFR §508.14).
2"Protecting American agriculture" is the basic charge ofAPHIS. APHIS provides leadership in ensuring the health and care ofplants and animals. The agency improves agricultural productivity and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural 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 ofBiotechnology (Coordinated Framework) (51 FR23302, 57 FR 22984). The Coordinated Framework, published bythe Office ofScience and Technology Policy, describes the comprehensive federal regulatorypolicy for ensuring the safety ofbiotechnologyresearch and products and explains how federal agencies will use existing Federal statutes in a manner to ensure public health and environmental safetywhile 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 permittedbytheir respective statutory authorities; (2) agencies are required to focus on the characteristics and risks ofthe biotechnologyproduct, not the process by which it is created; (3) agencies are mandated to exercise oversight ofGE organisms onlywhen 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 plantpest provisions in the Plant Protection Act of2000, as amended (7 USC§ 7701 etseq.) to ensure that they do not pose a plant pest risk to the environment.

The FDAregulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and proper labeling ofall plant-derived foods and feeds, including those that are genetically engineered. To help developers offood and feed derived from GE crops comply with their obligations underFederal 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 FDApolicy statement concerning regulation ofproducts derived from
newplant varieties, including those genetically engineered, was published in the Federal Register
onMay29, 1992 (57 FR 22984-23005). Under this policy, FDAuses what is termed a consultationprocess to ensure that human food and animal feed safety issues or otherregulatory issues (e.g., labeling) are resolvedpriorto commercial distribution ofbioengineered food.

The EPAregulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues ofpesticides 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

3

### regulating the sale, distribution and use ofpesticides, including pesticides that are produced by
an organism through techniques ofmodembiotechnology.
Regulated Organisms 

### The APHIS BiotechnologyRegulatory 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 ofGE organisms. APHIS regulations at 7 CFRpart 340, which were promulgatedpursuant to authority granted bythe Plant Protection Act, as amended (7 USC 7701-7772), regulate the introduction (importation, interstate movement, or release into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plant pest provisions ofthe Plant Protection Act orto the regulatory requirements of7 CFRpart 340 when APHIS determines that it is unlikelyto pose a plant pest risk. A GE organism is considered aregulated article ifthe 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 maybe a plant pest or APHIS does not have information to determine ifthe GE organism is unlikely to pose a plant pestrisk.

A person maypetition the agency that a particularregulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. The petitioner is required to provide information under§ 340.6(c)(4) related to plantpest risk that the agency mayuse to determine whetherthe regulated article is unlikely to present a greaterplant pest risk than the unmodified organism. A person may also request that APHIS extend a determination ofnonregulated status to other organisms under § 340.6(e)(2). Such arequest shall include information to establish the similarity ofthe antecedent organism and the regulated articles in question. AGE organism is
no longer subject to the regulatory requirements of7 CFRpart 340 orthe plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikelyto pose a plant pest risk.

APHIS' Response to Application for an Extension ofNonregulated Status 

### Under the authority ofthe plant pest provisions ofthe Plant Protection Act and 7 CFRpart 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 oftheregulated status ofGE organisms, including GE plants such as Event T303-3. When a request for an extension ofnonregulated status is submitted, APHIS must make a determination ifthe GE organism is similarto an antecedent organism which has previouslybeen determined to be unlikely to pose a plantpestrisk. If

### APHIS determines based on its Plant Pest Risk Assessment (PPRA) ofthe antecedent organism that the genetically engineered organism identified inthe extensionrequest is unlikelyto pose a plant pestrisk, the genetically engineered organism is no longer subject to the plantpestprovisions ofthePlantProtection Act and 7 CFRpart 340.

BCS has submitted a request to APHIS for an extension ofa determination ofnonregulated 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 anyprogeny derived from crosses ofEvent T303-3 with

4conventional cotton, and anyprogeny derived from crosses ofEvent T303-3 with other transgenic cotton varieties that have received a determination ofnonregulated status, no longer be considered regulated articles under 7 CFRpart 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 producedbyAgrobacteriummediated transformation utilizingvectorpTDL004 containing a crylAb gene construct, encoding insect-resistance, andthe bar gene as a selectable marker conferring tolerance to glufosinate ammonium herbicides. The antecedent organism, cotton event T304-40 as described inpetition 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 crystalprotein (ICP) Cry1Ab (expressionproduct ofthe crylAb gene) and PAT protein (expressionproduct ofthe bar gene). A comparison ofcharacteristics ofevents T303-3 and T304-40 is summarized in Table 1 ofBCS application for extension (Bayer 2012).

Coordinated Framework Review Food andDrugAdministration

Similarto the antecedent organism event T304-40, Event T303-3 is within the scope ofthe 1992 FDApolicy statement concerning regulation ofproducts 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 mayresult from a determination ofnonregulated status ofa GE organism. In the absence of
a completed FDA determination, APHIS takes into considerationpriorFDAreviews of comparableproducts to make a preliminary assessment ofthe potential impacts. Based onthe similarityto the antecedent organism event T304-40, the conclusions made byFDAfor TwinLinkTM Cotton are being used to assess potential impacts that mayresult from a determination ofnonregulated status ofEvent T303-3.

BCS provided the FDA with information on the identity, function, and characterization ofthe genes, for TwinLinkTM Cotton, including expression ofthe geneproducts. FDA evaluated BCS submission to determine whether the developer's product raises any safety orregulatory issues with respect to the intended modification orwithrespect to the food itself. Based on the informationprovidedbyBCS 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 wouldrequire 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-incorporatedprotectantproteins, are not materially different in composition or any otherrelevant parameter from other cotton varieties now grown, marketed, and consumed inthe U.S. Atthis 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 ofthe food and safety impacts associated with the incorporation and expression of

5pesticidal substances, in this case, the Cryproteins associated with Bt, are more limited. EPA is the primary authority for the review ofplant-incorporated protectants.
EnvironmentalProtectionAgency
The EPAhas authority overthe use ofpesticidal 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'sregulatory assessment when assessing potential impacts that mayresult from a determination ofnonregulated status ofa 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 PATprotein (40 CFR §174.522; US-EPA 2010c). A temporary exemption from the requirement ofa tolerance has been issued for Cry2Ae (40 CFR §174.530; US-EPA 2010b).

BCS developed and sought EPA registration oftwo 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 aproduct, TwinLinkTM Cotton that expresses bothproteins. BCS applied for EPApesticide registrations ofCry1Ab and Cry2Ae proteins as expressed in Events T304-40 and GHB119 cotton, respectively, and a new combination PIP product, TwinLinkTM cotton, createdthrough conventional breeding ofthese events for use as PIPs in 2009, under section 3 ofthe FIFRA. BCS concurrently filed a petition for a permanent exemption from the requirement ofa tolerance for Cry2Ae protein residues in or on food and feed commodities in cotton. EPAbelieves that, based upon its assessment ofthe data and information submitted byBCS, it is in the interest ofthepublic and the environment to issue the registrations proposed byBCS (US-EPA 2012).



### In addition to review ofthe crop with plant-incorporated protectants, EPA has authority under FIFRA to establishpesticide use restrictions; these use restrictions are presented onpesticide labels which are prepared during the pesticide registration process. The development ofa transformed cotton crop providingtolerance to glufosinate ammoniummayrequire 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 underthe trade name "LibertyLink" (BCS 2010). Glufosinate· ammonium-tolerant cotton was first available in the U.S. with the introduction ofLiberty 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 EPAis expected to publish a new label for glufosinate ammonium that also references the TwinLinkTMproduct varieties. APHIS used the current glufosinate label as the basis for its evaluation ofthe potential impacts associated with the use ofand exposure to glufosinate ammonium. Scope ofthe Environmental Analysis Based onthe similarityto the antecedent organism event T304-40, APHIS has concluded that the BCS extension request for a determination onthe regulated status for Event T303-3 encompasses the same scope ofenvironmental analysis as TwinLinkTM Cotton. APHIS reviewed and analyzed the information submitted in the extensionrequest byBCS (Bayer 2012) and has concluded that Event T303-3 is similar to the antecedent organism, event T304-40 and therefore, based onits

6Plant Pest Risk Assessment for TwinLinkTM cotton (USDA-APHIS 2010) APHIS has concluded that Event T303-3 is unlikelyto pose a plant pest risk (see Appendix A). Althougha determination ofnonregulated status ofEvent T303-3 would allow for newplantings ofEvent T303-3 to occur anywhere in the U.S., APHIS primarily focused the environmental analysis to those geographic areas that currently support cottonproduction. Similarto the antecedent organism event T304-40, a determination ofnonregulated status of Event T303-3 is not expected to increase cotton production, eitherbyits availability alone or accompanied by other factors, or cause an increase in overall GE cotton acreage. To determine areas ofcotton production, APHIS used data from the National Agricultural Statistics Service (NASS) 2007 Census ofAgriculture 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 ofany substantive new information that would warrant alteration ofthe existingNEPA documentation for TwinLinkTM Cotton, including the proposed action or analysis ofimpacts in the EA since the completion ofthe 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 orNEPA documentation since a determination ofnon-regulated status was announced on October 12, 2011 (76 FR 63278- 63279).

Inpreparing this NEPA decision/FONSI for Event T303-3, APHIS carefullyreviewed .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, Docketno. 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-daypublic review and commentperiod. Comments were required to be received on orbefore August 29, 2011. All comments were carefully analyzed to identifynew issues, alternatives, orinformation. 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 ofthe comments receivedbyAPHIS. The 2 comments expressed opposition to a determination ofnonregulated status ofTwinLinkTM Cotton, but did not change the analysis provided inthe PPRA or draft EA. These individuals did not mention their specific disagreement with APHIS' analyses of TwinLinkTM Cottondetailed inthe EA orthe PPRA (USDA-APHIS 2010); rather, they expressed their general opposition to genetically modified organisms (GMOs) or GE crops. Other claims suggest a negative impact ofGE cotton and GE plants onhuman health and environmental safetyin a general nature. Overall, people who expressed their opposition to a deterrn,ination ofnonregulated status did notprovide any supporting evidence for their claims. Comment documents maybe viewed at http://www.regulations.gov/#lsearchResults;dct=PS;rpp=1**O;po=O;s=aphis~20** 10-0102 Major Issues Addressed in the EA APHIS has concluded that the BCS extensionrequest for a determination ofnomegulated status ofEventT303-3 encompasses the same scope ofenvironmental analysis as
7TwinLinkTM Cotton. APHIS is not aware ofany substantivenew environmental or social issues associated with EventT303-3 thatwere not considered in the previous NEPA analysis completed for a determination on the regulated status ofa petition request for TwinLinkTM Cotton. Therefore, APHIS is using the same issues identified and analyzed 

### in the existing NEPA documentation for TwinLinkTM Cotton to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated status ofan extension request byBCS for Event T303-3.

The issues considered in the TwinLinkTM Cotton EAwere developed based on APHIS' determination that certain genetically engineered organisms are no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340, and for this particular EA, the specific petition seeking a determination ofnonregulated status ofTwinLinkTM Cotton. Issues discussed in the EAwere developed byconsidering public concerns as well as issues raised in public comments submitted for other environmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well as those issues that have been raised byvarious stakeholders. These issues, including those regarding the agricultural production ofcotton using various production methods, and the environmental and food/feed safety ofgenetically engineered plants were addressed to analyze the potential environmental impacts ofTwinLinkTM 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 ofthe analysis (40 CFR 1508.25) for TwinLinkTM Cotton. These same issues have been determined byAPHIS 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 ofCotton Production
• Cropping Practices
• Seed Production
• Organic Farming
• Specialty CottonProduction

Environmental Considerations

• Water Resources
• Soil
• Air Quality
• Climate Change
• Animals
• Plants
• Biological Diversity
• Gene Movement

PublicHealth Considerations
• Human Health
• Worker Safety
8• 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 ofnonregulated status ofEvent T303-3 encompasses the same scope ofenvironmental analysis and regulatory decision
as TwinLinkTM Cotton; that is a determination ofnonregulated status under 7 CFRpart 340. APHIS reviewed and analyzed the information submitted in the extension request byBCS (Bayer 2012) and has concluded that Event T303-3 is similarto 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 ofcharacteristics ofEvent T303-3 to the antecedent organism, event T304-40, indicates that Event T303-3 expresses the same Cry1Ab and PAT/barproteins as event T304-40; Event T303-3 expresses the same resistance to lepidopteran pests and glufosinate ammoniumherbicide tolerance as TwinLinkTM Cotton; and Event T303-3 does not exhibit any additional traits beyond what is expressed inTwinLinkTM Cotton. Therefore, the proposed action identified in the existing NEPA 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 EAto be relevant to APHIS' regulatory actions associated with Event T303-3 and therefore are being used in their entirety. APHIS is not aware ofanynew 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 inthe existing NEPA documentation completed for TwinLinkTM Cotton to evaluate and determine ifthere are anypotentially significant impacts to the human environment from a determination ofnonregulated status ofEvent T303-3.

Alternatives described in existing TwinLinkTMCotton EA The EA analyzes the potential environmental consequences ofa determination ofnonregulated status ofTwinLinkTM Cotton. To respond favorably to a petition for nonregulated status, APHIS must determine that TwinLinkTM Cotton is unlikely to pose a plant pestrisk. Based on its Plant Pest Risk Assessment (USDA-APHIS 2010) APHIS has concluded that TwinLinkTM Cotton is unlikelyto pose a plantpest risk. Therefore, APHIS must determine that TwinLinkTM Cotton is
no longer subject to 7 CFRpart 340 or the plant pestprovisions ofthe Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination ofnonregulated status ofTwinLinkTM Cotton. APHIS has assessed the potential for environmental impacts for each alternative in the "Environmental Consequences" section ofthe 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 ornotifications acknowledged byAPHIS 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 ifthere were insufficient evidence to demonstrate the lack ofplant 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 unlikelyto pose aplant pest risk. Choosing this alternative would not satisfy the purpose andneed ofmaking a determination ofplantpestrisk status andresponding 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 unlikelyto pose a plant pest risk (USDA-APHIS 2010). Permits issued ornotifications acknowledged by APHIS would no longerbe required for introductions ofTwinLinkTM Cotton and progeny derived from this event. This alternative best meets the agency'spurpose 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 ofthe Plant Protection Act. Because the agency has concluded that TwinLinkTM Cotton is unlikelyto pose a plant pest risk, a determination ofnonregulated status ofTwinLinkTM Cotton is aresponse that is consistent with the plantpest provisions ofthe PPA, the regulations codified in 7 CFR part 340, and the biotechnologyregulatorypolicies 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 butRejected from Further Consideration 

### APHIS assembled a list ofalternatives that might be considered for TwinLinkTM Cotton. The agency evaluated these alternatives, in light ofthe agency's authority underthe plant pest provisions ofthe PlantProtection Act, and the regulations at 7 CFR part 340, with respect to environmental safety, efficacy, and practicalityto identify which alternatives wouldbe further considered for TwinLinkTM Cotton. Based onthis evaluation, APHIS rejected several alternatives. These alternatives are discussed brieflybelow along with the specific reasons for rejecting each. ·
Prohibit any TwinLinkTM Cotton from beingreleased In

### response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibitingthe release ofTwinLinkTM Cotton, including denying any permits associated with the field testing. APHIS determined that this alternative is not appropriate given that APHIS has concludedthat TwinLinkTM Cotton is unlikely to pose a plant pestrisk (USDA-APHIS 2010).

In 

### enacting the Plant Protection Act, Congress found that

10

### [D]ecisions affecting imports, exports, and interstate movement ofproducts 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 InteragencyPolicy Coordination Committee developed broadprinciples, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemerging 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 permittedbylaw, when regulating emerging technologies:
"[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries ofthe authorities and mandates ofeach agency''

Based on ourPlant PestRisk 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 ofTwinLinkTM Cotton. Approve the petition in part The regulations at 7 CFR 340.6(d)(3)(i) state thatAPHIS may "approve the petition in whole
or inpart." For example, a determination ofnomegulated status inpart maybe 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 plantpestrisk, there is no regulatorybasis under the plant pestprovisions ofthe Plant Protection Act for considering approval ofthe petition only in part.
Isolation distance between TwinLinkTM Cotton and non-GE cotton and geographical restrictions Inresponse to public concerns ofgene movementbetween GE and non-GE plants, APHIS consideredrequiring an isolation distance separating TwinLinkTM Cotton from non-GE.cotton production. However, because APHIS has concluded that TwinLinkTM Cotton is unlikely to pose a plantpestrisk (USDA-APHIS 2010), an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plant pest provisions ofthe Plant Protection Act andregulations in 7 CFRpart 340.

APHIS also considered geographically restricting the production ofTwinLinkTM Gorton based on the location ofproduction ofnon-GE cotton in organic production systems in response to public
concerns regarding possible gene movementbetween 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 pestrisks 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 plantpest risk, and will not exhibit a greater plantpest risk in any geographicallyrestricted area. Therefore, such an alternative would not be consistent with APHIS' statutory authority under the plant pest provisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnologyregulatorypolicies embodied inthe Coordinated Framework.
11Based on the foregoing, the imposition ofisolation distances or geographic restrictions would not meet APHIS' purpose and need to respond appropriately to apetition for nonregulated status based on the requirements in 7 CFRpart 340 and the agency's authority under the plant pest provisions ofthe Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. However, individuals might choose on their ownto geographically isolate their non-GE cotton productions systems.from TwinLinkTM Cotton orto use isolation distances and other management practices to minimize gene movementbetween cotton fields. Requirement ofTestingFor 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 innon-GE production systems. APHIS notes there are no nationally-establishedregulations involving testing, criteria, or limits ofGE material in non-GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, because TwinLinkTM Cotton does notpose a plantpest risk (USDA-APHIS 2010), the imposition ofany type oftesting requirements is inconsistent with the plant pestprovisions ofthe Plant Protection Act, the regulations at 7 CFR part 340 and the biotechnologyregulatorypolicies embodied in the Coordinated Framework. Therefore, imposing such a requirement for TwinLinkTM Cotton would notmeet APHIS' purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.



### Environmental Consequences ofAPHIS' Selected Action Based on the similarityofthe antecedent organism event T304-40 to Event T303-3 (see Appendix A), APHIS has concluded that the previous analysis ofimpacts completed for TwinLinkTM Cotton to be relevant to APHIS' regulatory actions associated with responding to the BCS extensionrequest for Event T303-3. The potential impacts ofEvent T303-3 on agricultural production ofcotton, 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 entiretyto evaluate APHIS' action associated with a determination ofnonregulated status ofEvent T303-3. The TwinLinkTM Cotton EA contains a full analysis ofthe alternatives to which we referthe reader for specific details. The following table briefly summarizes the results for each ofthe issues fully analyzed inthe Environmental Consequences section ofthe EA.

Meets Purpose and Need and Objectives ,. ,·,

'**;·.::(~·\** ""!,,·' <:·<;:.

.**~·.:·{::,:**·.. 

### "<>.:

..· .·_. Altllrnative .A:: No A.C'tion

.. No Unlikely to pose a plantpest risk Satisfied through use of regulated field trials Management Practices

Acreage and Areas ofCotton 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 CommunitiesAnimals 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 EPAbiopesticide registration complete
Compliance with Other Laws CWW, CAA, EOs Fully compliant Fully compliant

Unchanged

- the current conditions will not change as a result ofthe selection ofthis alternative. Notes: 1. 2. Minimal

- the current conditions may change slightly as a result ofthe selection ofthis alternative, but the changes, ifany, are not deemed significant.



### Finding ofNo Significant Impact Based on the analysis ofimpacts in the existing TwinLinkTM CottonEA and the similarity of Event T303-3 to the antecedent organism event T304-40, a determination ofnonregulated status ofEvent T303-3 will not have a significant impact, individually or cumulatively, onthe quality ofthe human environment. I agree with this conclusion and therefore find that an environmental impact statement need notbeprepared. This NEPA 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 inwhich the environmental impactwould occur. This actionhas potential to affect

13

### conventional and organic cottonproduction systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commodity markets. Most ofthe cotton acreage in the U.S. is planted to GE cotton. Ofthe 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). A determination ofnonregulated status ofEventT303-3 is not expectedto directly cause an increase in·agricultural acreage devoted to cotton production, or those cotton acres devoted to GE cotton cultivation. The availability ofEventT303-3 will not change cultivation areas for cotton production in the U.S. and there are no anticipated changes to the availability ofGE and non-GE cotton varieties on the market. Although a determination ofnonregulated status ofEventT303-3 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 cottonproduction. A determination ofnonregulated status ofEvent T303-3 is not expected to increase cotton production, eitherby its availability alone or accompanied byother factors, or cause an increase in overall GE cotton acreage. Intensity

- 

### Intensityis a measure ofthe degree or severity ofan impact based upon the ten factors. The following factors were used as a basis for this decision:

1. Impacts that may be both beneficial andadverse. 

### A determination ofnonregulated status ofEvent T303-3 will have no significant environmental impact in relation to the availability ofGE, conventional, organic or specialty cotton varieties. Based on the discussions in Chapter 4 ofthe 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. The availability ofEvent T303-3 will not change cultivation areas for cottonproduction in the U.S. and there are no anticipated changes to the availability ofGE and non-GE cotton varieties on the market. A determination ofnonregulated status ofEventT303-3 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 ofthe cotton acreage in the U.S. is planted to GE cotton. Ofthe 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). Baseduponrecenttrend information, adding GE varieties to the market is notrelated to the ability oforganic production systems to maintain their market share. Between 2000 and 2008, although 12 GE cotton events or lines were no longer subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340, the acreage associated with the organic production ofcottonremained at slightly above 15,000 acres (USDA-ERS 2010c). Based on the data provided byBCS on the antecedent organism T304-40 cotton (Bayer 2010), as well as previous experience with other Bt cotton varieties that have been widely adopted bygrowers since their introduction in 1996 (USDA-ERS 2010a), APHIS has concluded that the availability ofEvent T303-3 would·

14not alter the agronomic practices, locations, and seed production and quality characteristics ofconventional and GE seed production. A determination ofnonregulated status ofEvent T303-3 will notrequire a change to seedproductionpractices. A determination ofnonregulated status ofEventT303-3 is not expected to result in changes in the current cotton cropping practices. As discussed in Chapter 4 ofthe TwinLinkTM Cotton EA, studies demonstrate the antecedent organism T304-40 cotton is essentially indistinguishable from other cotton varieties used in terms ofagronomic characteristics and cultivationpractices (Bayer 2010). IfEvent T303-3 is adopted, a continued reduction inthe use ofbudwormlbollworm insecticides applications and the number ofacre-treatments per year as reported inBenbrook's trend analysis (Benbrook 2009) is expected to occur. A determination ofnonregulated status ofEvent 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 ofEvent 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. Inthose 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 couldreduce applications ofthose other herbicides needed to manage glyphosate-resistant weeds. 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofEveritT303-3 wouldhave no significant impacts onhuman or animal health. As discussed in Chapter 4 ofthe TwinLinkTM Cotton EA, similarproducts were no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340 beginning in 1996 with the introduction ofBt products and followed shortly after bythe introduction ofthe various "Liberty"products whichprovided tolerance to glufosinate ammonium. Ineach case, FDA and EPA reviews and approvals determined that the products met the agency's review criteria for approval. The cultivation ofthese existing crop products would not change under either alternative. Both characteristics have been successfully cultivated in multiple crops in the ensuing years withno evidence ofhuman health impacts. BCS provided the FDA with information onthe identity, function, and characterization ofthe genes, for TwinLinkTM Cotton, including expression ofthe gene products. FDA evaluated BCS submission to determine whether the developer's product raises any safety or regulatory issues withrespect to the intended modification or with respect to the food itself. Based
on the information provided byBCS and other information available to the agency, FDA did not identify any safety orregulatory issues under the Federal Food, Drug and Cosmetic Act or current FDA regulations that wouldrequire further evaluation at this time (US-FDA 2011). BCS applied for EPApesticide registrations ofCry1Ab 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 ofthese events for use as PIPs in 2009, under section 3 ofthe FIFRA. BCS concurrently filed a petition for a permanent exemption from the requirement ofa tolerance for Cry2Ae proteinresidues in or on food and feed commodities in cotton. EPAbelieves that, based upon its assessment ofthe data and information submittedby

15BCS, it is in the interest ofthe public and the environment to issue the registrations proposed byBCS (US-EPA 2012). Basedon the analysis offield and laboratory data and scientific literature providedbyBCS on TwinLinkTM Cotton (Bayer 2010); the safety data available on other GE cotton; FDA' conclusions onthe TwinLinkTM Cotton; EPA' registration ofCrylAb and Cry2Ae proteins as expressed inEvents T304-40 and GHB119 cotton, respectively, and a new combination PIP product, TwinLinkTM cotton; andits similarityto 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 asproximity to historic or cultural resources, parklands, prime farmlands, wetlands, wildandscenic rivers, or ecologically critical areas. There are no unique characteristics ofgeographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas that would be adversely impactedby 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 anyphysical destruction or damage to property; do not cause any alterations of property, wildlife habitat, or landscapes; and do not involve the sale, lease, ortransfer of ownership ofany property. This action is limited to a determination ofnonregulated status ofEvent T303-3. Similarto the antecedent organism T304-40, the product will be deployed on agricultural land currently suitab'Ie for production ofcotton and is not expected to increase the acreage ofcottonproduction. This action would not convert land use to nonagricultural use and therefore would have no adverse impact onprime farm land. Standard agricultural practices for land preparation, planting, irrigation, and harvesting ofplants would be used on agricultural lands planted to Event T303-3, including the use ofEPAregistered pesticides. Applicant's adherence to EPAlabel use restrictions for all pesticides will mitigate potential impacts to the human environment. Inthe event ofa determination ofnonregulated status ofEvent T303-3, the action is not likelyto affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas that maybe in close proximityto 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 ofthe human environment from a determination of nonregulated status ofEvent 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 ofsize, nature or effect onthe natural orphysical environment. Based onthe discussions in Chapter 4 ofthe TwinLinkTM Cotton EA and its similarityto the antecedent organism event T304-40, a determination ofnonregulated status ofEventT303-3 is not expectedto directly cause an increase in agricultural acreage devotedto cottonproduction, orthose cotton acres devoted to GE cotton cultivation. The availability ofEventT303-3 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 ofcottonproduction or

16current cotton croppingpractices. Itis anticipated that the trend ofreduced broadspectrum insecticide use bycotton growers will continue due to the adoption ofBt cotton and other cultural practices. There is the potential that the introduction ofglufosinate ammonium tolerance mayresult in a reduction in total herbicide use as growers adopt different herbicide treatment strategies involving glufosinate ammonium as a postemergent crop treatment, therebyreducing the use ofsome ofthe otherherbicides which have beenrequired in response to the emergence ofglyphosate-resistant weeds. Similar to the antecedent organism T304-40, the effect ofEvent T303-3 on wildlife or biodiversity is no different than that ofother GE ornon-GE cottonproduced 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 onthe similarityto the antecedent organism T304-40, cultivation ofEvent T303-3 does not otherwise require a change in the rates offertilizer application, tillage, planting, or harvesting from existing commercial cotton varieties, including other GE cotton varieties providing eitherinsect resistance, herbicide tolerance, or stacked withboth (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 ofthe comments received byAPHIS. These individuals did not mention their specific disagreement with APHIS' analyses ofTwinLinkTM Cotton detailed in the EA orthe PPRA (USDA-APHIS 2010); rather, they expressed their general opposition to geneticallymodified organisms (GMOs) or GE crops. Other claims suggest a negative impact ofGE cotton and GE plants onhuman health and environmental safety in a general nature. Overall, people who expressed their opposition to a determination ofnonregulated 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 NEPA documentation since a determination ofnon-regulated status
was announced on October 12, 2011 (76 FR 63278-63279). 5. The degree to which thepossible effects on the human environment are highly uncertain
or involve unique or unknown risks. Based onthe analysis documented inthe TwinLinkTM Cotton EA and its similarityto the antecedent organism event T304-40, the possible effects onthe human environment from
a determination ofnonregulated status ofEvent T303-3 are well understood. The effects oftheproposed activities are not highlyuncertain and do not involve unique orunknown risks onthe natural orphysical environment. Based onthe discussions in Chapter 4 of the TwinLinkTM Cotton EA and its similarityto the antecedent organism event T304-40,
a determination ofnonregulated status ofEventT303-3 is not expectedto directly cause an increase in agricultural acreage devoted to cottonproduction, orthose cotton acres devoted to GE cotton cultivation. Similar to the antecedent organism T304-40, a determination ofnonregulated status ofEventT303-3 is not expected to result in changes in the current cotton croppingpractices. BCS' studies demonstrate TwinLinkTM Cotton is essentially indistinguishable from other cotton varieties used in terms ofagronomic characteristics and cultivationpractices (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 onthe similarityto the antecedent organism T304-40, the cultivation ofEvent T303-3 does not otherwise require a change

17

### in the rates offertilizer 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 ofreduced broad-spectrum insecticide use bycotton growers will continue due to the adoption ofBt cotton and other cultural practices. There is the potential that the introduction ofglufosinate ammonium tolerance may result in a reduction intotal herbicide use as growers adopt different herbicide treatment strategies involving glufosinate ammonium as a post-emergent crop treatment, therebyreducing the use of
some ofthe otherherbicides 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 orbiodiversity is no different than that ofother GE or non-GE cottonproduced in conventional agriculture in the U.S. As described in Chapter 4 ofthe TwinLinkTM Cotton EA, well established management practices, production controls, and productionpractices (GE, conventional, and organic) are currentlybeing 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 specialtysystems, will continue to use these reasonable, commonly accepted best managementpractices for their chosen systems and varieties during agricultural cotton production. Additionally, most ofthe cotton acreage in theU.S. is planted to GE cotton. Ofthe 11.3 million acres planted in cotton in 2010, 93% (10.5 million acres) were GE cotton. Ofthis, 73% ofthe GE cotton acreage was GEinsect-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 ofacreage with
orwithout a determination ofnonregulated status ofEvent T303-3. Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use ofGE cottonproducts, the possible effects to the human environment from the release ofa an additional GE cotton product are alreadywell known and understood. Therefore the impacts are not highly uncertain, and do not involve unique orunknown risks. 6. The degree to which the action may establish aprecedent for future actions with significant effects or represents a decision inprinciple about afuture consideration. 

### A determination ofnonregulated status ofEventT303-3 would not establish aprecedent for future actions with significant effects or represent a decision inprinciple about a future decision. Similarto past regulatoryrequests reviewed and approved byAPHIS, a determination ofnonregulated 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 of7 CPR part 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes this independent review to determine ifthe regulated article poses a plantpest risk. Under the authority ofthe plantpest provisions ofthe Plant Protection Act and 7 CPRpart 340, APHIS has issued regulations for the safe development and use ofGE organisms. Asrequired by 7 CPR 340.6, APHIS must respond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as Event T303-3. When a request for an extension ofnonregulated status is submitted, APHIS must make a determination ifthe GE organism is similar to an antecedent organism which has previouslybeen determined to be unlikely to pose aplantpest risk. IfAPHIS determines based on its PlantPestRisk

18Assessment ofthe 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 CFRpart 340. APHIS regulations at 7 CPRpart 340, which were promulgatedpursuant to authority grantedbythe Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to
one ofthe 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 maybe a plantpest orAPHIS does not have information to determine if the GE organism is unlikelyto pose a plant pest risk. A person maypetition the agency that a particularregulated article is unlikely to pose a plant pestrisk, and, therefore, is no longer regulated under the plant pest provisions ofthe Plant Protection Act or the regulations at 7 CPR 340. Thepetitioner is required to provide information under§ 340.6(c)(4) related to plantpest risk that the agency mayuse to determine whether the regulated article is unlikely to present a greater plant pestrisk than the unmodified organism. A person may also request that APHIS extend a determination ofnonregulated status to other organisms under§ 340.6(e)(2). Such a request shall include information to establish the similarity ofthe antecedent organism and the regulated articles in question. A GE organism is no longer subject to the regulatoryrequirements of7 CPRpart 340 or the plantpest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plantpestrisk. 7. Whether the action is related to other actions with individually insignificant but cumulatively significant impacts. Based onthe similarity ofthe antecedent organism T304-40 to Event T303-3, no significant cumulative effects were identifiedthrough this assessment. The TwinLinkTM Cotton EA discussed cumulative effects on cotton managementpractices, 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 ofthe TwinLinkTM CottoJ;I EA. In the event ofa determination of nomegulated status, similarto the antecedent organismT304-40, EventT303-3 maybe stacked (combined) withnon-GE and GE cottonvarieties bytraditional breeding techniques, resulting in a plantthat, for example, may also beresistantto other herbicides, ormaypresent a different combination ofinsectpest-resistant, butmay also have progenywithno transgenes at all. Similarto the antecedent organismT304-40, there is no guarantee that Event T303-3 willbe stacked with anyparticular non-GE or GE cotton varieties that are no longer subject to the plantpestprovisions ofthePlant Protection Act and 7 CPRpart 340, as companyplans and market demands play a significant role in those business decisions. Thus, predicting all potential combinations ofstacked varieties that couldbe created using bothnon-GE and GE cotton varieties that
are no longer subject to the plantpest provisions ofthe Plant Protection Act and 7 CPR part 340 is hypothetical and purely speculative. Based onthe analysis documented in the TwinLinkTM CottonEA and its similarityto the antecedent organism event T304-40, in the event ofa determination ofnonregulated status ofEvent T303-3, APHIS has not

19

### identified any significant impact on the environment which mayresult from the incremental impact ofa determination o_fnonregulated status ofEvent T303-3 when added to otherpast, present, and reasonably foreseeable future actions. 8. The degree to which the action mayadversely affect districts, sites, highways, structures,
or objects listed in or eligible for listing in the NationalRegister of Historic Places or may cause loss ordestruction of significantscientific, cultural, or historical resources. 

### Based on the analysis documented in the TwinLinkTM CottonEA and its similarity to the antecedent organism event T304-40, a determination ofnonregulated status ofEvent T303-3 is not expected to adversely impact cultural resources ontribal properties. Any farming activities that maybe taken byfarmers on tribal lands are only conducted at the tribe's request; thus, the tribes have control over anypotential conflict with cultural
resources on tribal properties. Similarto the antecedent organism T304-40, a determination ofnonregulated 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 ofHistoric 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 ofEvent T303-3. Similar to the antecedent organism T304-40, standard agricultural practices for land preparation, planting, irrigation, and harvesting ofplants would be used on agriculturallands planted to Event T303-3, including the use ofEPAregistered 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 oruse ofhistoric properties. For example, there is potential for audible effects on the use and enjoyment ofa historic propertywhen
common agricultural practices, such as the operation oftractors and other mechanical equipment, are conducted close to such sites. A built-inmitigating factor for this issue is that virtually all ofthe methods involved would onlyhave temporary effects on the audible nature ofa 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 cottonproduction regions. The cultivation ofEvent T303-3 does not inherently change any ofthese agronomic practices so as to give rise to an impact under the NHPA. 9. The degree to which the action may adversely affect an endangered or threatenedspecies
or its habitat that has been determined to be critical under the EndangeredSpeciesActof 1973. 

### As described in Chapter 4 ofthe 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 ofthe Endangered Species Act. APHIS has obtained and reviewedthe USFWS list ofThreatened and Endangered Species (http:/I

### ecos.fws.gov /tess public/StateList:ing.do?state= vVV

### &status= listed) andbased on



### 20the analysis documented 

### in the TwinLinkTM Cotton EA and its similarityto the antecedent organism eventT304-40, APHIS has reached a conclusionthat a determination ofnomegulated status ofEventT303-3 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. I0. Whether the action threatens a violation of Federal, State, or local law or requirements imposed for theprotection of the environment. The proposed action, a determination ofnonregulated status ofEvent 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 aplantpestrisk, a determination ofnonregulated status ofEvent T303-3 is a response that is consistent with the plantpestprovisions ofthe PPA, the regulations codified in 7 CFR part 340, and the biotechnologyregulatory policies in the Coordinated Framework. Similar to the antecedent organism event T304- 40, Event T303-3 is within the scope ofthe 1992 FDApolicy statement concerning regulation ofproducts derived from new plant varieties, including those developed through biotechnology (US-FDA 1992). EPA has authority over the use ofpesticidal substances and plant-incorporatedprotectants under the FIFRA as amended (7 USC §136, etseq.) and the FFDCA (21 USC §301, etseq.). There are no other Federal, state,
or local permits that are needed priorto the implementation ofthis action.

NEP A Decision and Rationale I have carefullyreviewed the existing NEPA documentation completed for TwinLinkTM Cotton, including input from the public involvementprocess. Based onAPHIS' conclusion that Event T303-3 encompasses the same scope ofenvironmental analysis and regulatory decision as TwinLinkTM Cotton; that is a determination ofnonregulated status under 

### 7 CFRpart 340, I believe the issues identified and analyzed in the existing NEPA 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 ofgenetically engineered organisms consistent with the plant pest provisions ofthe Plant ProtectionAct.

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the agencybelieves would fulfill its statutorymission and responsibilities, giving consideration to economic, environmental, technical and other factors." A determination ofnonregulated status ofEvent T3030-3 has been selected for implementation based on consideration ofa number of environmental, regulatory, and social factors. Basedupon our evaluation and analysis, a determination ofnonregulated status ofEvent T3030-3 is selectedbecause (1) it allows APHIS to fulfill its statutorymission to protect America's agriculture and environment using a sciencebased regulatory framework that allows for the safe development and use ofgenetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified anyplantpest risks associated with Event T303-3, the continued regulated status ofEvent T303-3 would be inconsistent with the plant pest provisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. Forthe 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 DeputyAdministrator BiotechnologyRegulatory Services Animal and PlantHealth Inspection Services U.S. Department ofAgriculture

Literature Cited: Date:

BCS (201 0). Ignite® 280 SLHerbicide 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 byAL 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 ofthe Determination ofNonregulated Status for Insect-Resistant, Glufosinate Ammonium-Tolerant Cotton (08-340-01p): Transformation Event T303-3. SubmittedbyMichael 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 ofGenetically 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** 

### ofa Tolerance, 40 CFR §174.511.

US-EPA (2010b) Bacillus thuringiensis 

### Cry2Ae Protein in Cotton; Temporary Exemption from the Requirement ofa Tolerance, 40 CFR §174.530

US-EPA. (201Oc) 

### 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 CrylAbprotein and the Genetic Material Necessary for its Production inEvent T304-40 Cotton [PC Code 006525, OECD Unique Identifier: BCSGH004-7]; Bacillus thuringiensis Cry2Ae protein and the Genetic Material Necessary

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### 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 ofPesticide Programs, Biopesticides and PollutionPrevention Division. January 26, 2012. http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2011-0988

US-FDA (1992). Statement ofPolicy- Foods Derived from New Plant Varieties. Retrieved January 18, 2011 from http://w.,vw

### .fda.gov

### IFood/GuidanceComplianceRegulatorylnformation/GuidanceDocume nts/Biotechnology/ucm096095.htm

US-FDA (2011). Biotechnology Consultation Note to the File BNF No. 000118. http:/ /w-ww.fda.gov/Food!Bioteclmology/Submissions/ucm271378.htm

USDA-APHIS (2010) Determination ofPlant 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 ofGenetically 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 ofGeneticallyEngineered 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 ofAgriculture: 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

23Appendix A. Similarity ofCotton 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 ofgenetically engineered (GE) cotton event T303-3. The extension request refers to BayerTwinLinkTM cotton as the comparator or antecedent organism. GE cotton event T304-40 is one oftheparents ofBayer CropScience TwinLinkTM cotton, which
was submitted for nomegulated status December22, 2008 (APHIS petition number 08-340-01p) and received a determination ofnon-regulated status from APHIS on October 12, 2011 (76 FR 63278-63279). A comparison ofa variety ofcharacteristics ofT303-3 and T304-40 cottons follow this text. Functionally, the two cotton varieties are resistant to the identical types ofpests as well as the
same herbicide. They are similar in that theyboth express a CrylAb protein from Bacillus thuringiensis and a phosphinothricin acetyltransferase (PAT) protein from Streptomyces hygroscopicus. The primary difference between these two cotton varieties is the presence ofa Ps7s7 subterranean clover stunt virus promoter in T304-40 versus a P35S2 cauliflowermosaic virus promoter in T303-3. Bothpromoters drive expression ofthe CrylAb gene in their respective varieties, and the difference in promoters does not change the similarity in the proteins producedbetween the two varieties. Because the CrylAb and PATproteins are similar between the two varieties, the protein inT303-3 cotton will notbe substantively different than that found in T304-40.

Disease and pest susceptibility: Similarto 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 oftrials (Bayer CropScience, 2012, Section VII.C. and Appendix 1, pp 57-86).
Outcrossing to wildrelatives: Similar to observations made onTwinLinkTM cotton, the T303-3 line produces heavy, stickypollen and is considered to be primarily selfpollinating. As such, outcrossing to other cotton (Gossypium hirsutum, G. tomentosum, G. barbadense, G. thurberi) canbe expectedto be the same (Bayer CropScience, 2012, Section VIII.A., p. 49).

Weediness potential: Similarto phenotypic observations made on TwinLinkTM cotton, observations and data collected for T303-3 did not indicate any increasedpotential 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 ofnodes, seed production, etc).
Nontarget orbeneficial 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/orbeneficial organisms will be identical. Those assessments were conducted byBayer and noted minimal to no risk to nontarget organisms (Bayer 2008, Section IX, pp. 79-85).

24Transfer ofgenetic material to organisms with which it cannot interbreed: Bayernotes nothing significant about either ofthese plants that would increase the potential for horizontal gene transfer (Bayer 2008, p 79: Bayer 2012, p. 49).

After a thorough review ofthe BCS extensionrequest, BRS concludes that Event T303-3 is similarto 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 unlikelyto pose a plantpestrisk. Similar to the conclusions found 

### in the plant pest risk assessment for TwinLinkTM cotton (USDA-APHIS 2010), that is, due to the lack ofplant pestrisk from the inserted genetic material, the lack ofweediness characteristics, the lack of atypical responses to disease or plant pests in the field, the lack ofdeleterious effects on nontargets orbeneficial organisms inthe agro-ecosystem, andthe lack ofhorizontal gene transfer, APHIS has concluded that Event T303-3 is unlikely to pose a plantpestrisk.

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 ofthe Determination ofNomegulated Status for Insect-Resistant, Glufosinate Ammonium-Tolerant Cotton (08-340-01p): Transformation Event T303-3

USDA-APHIS. 2010. Determination ofPlant 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

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