### NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND FINDING OF NO SIGNIFICANT IMPACT
Bayer CropScience Insect Resistant and GlufosinateAmmonium-Tolerant (TwinLinkTM) Cotton, Events T304-40 x GHBl19

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 comply with the requirements ofthe National Environmental Policy Act (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementingNEPA, 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. Comments from the public involvement process were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementing NEPA (7 

### CFRpart 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated status ofa petition request (APHIS Number 08-340-01p) by Bayer CropScience (BCS) for their genetically engineered TwinLinkTM Cotton Events GHBl19 and T304-40. 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 traitbased on LibertyLink@ technology. This EA has been prepared in order to specifically evaluate the effects on the quality ofthe human environmentI 

### thatmayresult from a determination ofnonregulated status of TwinLinkTM Cotton. The EA assesses alternatives to a determination ofnonregulated status of TwinLinkTM Cotton and analyzes the potential environmental and social effects that result from the proposed action and the alternatives.
Regulatory Authority "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, orthe use of

, Under NEPA regulations, the "human environment" includes "the natural and physical environment and the relationship ofpeople with that environment" (40 CFR §50S.14).
1genetically engineered (GE) varieties) can provide benefits to the environment, consumers, and farm income.

Since 1986, the United States government has regulated genetically engineered (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 ofScience and Technology Policy, describes the comprehensive federal regulatory policy for ensuring the safety ofbiotechnology 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 ofthe biotechnology industry. The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extentpermitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks ofthe biotechnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight ofGE 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'sAPHIS, 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 etseq.) to ensure that they do not pose a plant pest risk to the environment.

The FDA regulates 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 FDA policy statement concerning regulation ofproducts derived from

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

on .Yfay 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 otherregulatory issues (e.g., labeling) are resolved priorto commercial distribution ofbioengineered food.

The EPA regulates plant-incorporated protectants under the Federallnsecticide, 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 Aet (FFDCA) and regulates certainbiological control organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for regulating the sale, distribution and use ofpesticides, including pesticides that are produced by

an organism through techniques ofmodern biotechnology.
Regulated Organisms

2

### 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 ofGE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgatedpursuant to authority granted by the PlantProtection 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 no longer subject to the plantpest provisions ofthe PlantProtection Act orto the regulatory requirements of7 CFRpart 340 when APHIS determines that it is unlikely to pose a plant pestrisk. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, orvectoragent 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. A GE organism is also regulated underPart 340 when APHIS has reason to believe that the GE organism may be a plantpest or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pestrisk.

A person may petition the agency that a particularregulated article is unlikely to pose a plant pestrisk, and, therefore, is no longerregulated underthe plantpestprovisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. The petitioneris required to provide information under § 

### 340.6(c)( 4) related to plantpestrisk thatthe agency may use to determine whether the regulated article is unlikely to present a greaterplantpestrisk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of7 CFRpart 340 orthe plant pest provisions ofthe Plant Protection Act when APHIS determines that itis unlikely to pose a plantpestrisk.



### APHIS' Response to Petition for Nonregulated Status Underthe authority ofthe plant pestprovisions ofthe Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the safe development and use ofGE organisms. Asrequired by 7 CFR 340.6, APHIS mustrespond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as TwinLinkTM Cotton. When a petition for nonregulated status is submitted, APHIS must make a determination ifthe GE organism is unlikelyto pose a plant pestrisk. IfAPHIS determines based on its Plant Pest Risk Assessment (PPRA) thatthe genetically engineered organism is unlikely to pose a plantpestrisk, the genetically engineered organism is no longer subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340.
BayerCropScience has submitted a petition (APHIS Number08-340-01p) to APHIS seeking a determination that their genetically engineered TwinLinkTM Cotton Events GHBl19 and T304­ 40 are unlikely to pose a plantpestrisk and, therefore, should no longerbe a regulated article underregulations at 7 CFR Part 340.



### BSC TwinLinkTM Cotton Events GHBl19 and T304-40 BCS has developed the TwinLinkTM Cotton as an alternative insect-resistant and herbicide­ tolerant cotton product. BCS has developed upland or Mexican cotton (Gossypium hirsutum) 

### plants that express two insecticidal crystalline proteins, CryiAb and Cry2Ae, derived from the
common soil bacterium, Bacillus thuringiensis (Bt). 

### The CrylAh and Cry2Ae proteins in TwinLinkTM Cotton are effective in controlling lepidopteran larvae such as bollworm (CBW,

3Helicoverpa zea), tobacco budworm (TBW, Heliothis virenscens), and fall armyworm (FAW, SpodopteraJrugiperda) which are common pests ofcotton. The rationale for using two Btgenes is that target insects are much less likely to develop resistance to both proteins simultaneously than to develop resistance to one toxic protein. In addition to the Cry1Ab and Cry2Ae proteins, the TwinLinkTM Cotton contains the modifying phosphinothricin-acetyl-transferase (PAT) enzyme, encoded by the bargene which confers tolerance to glufosinate ammonium-based herbicides. The bar gene, derived from Streptomyces hygroscopicus, encodes the PAT enzyme which acts to convert glufosinate ammonium into its inactive form, thus rendering the plant tolerant to the herbicide. This is the same enzyme that is expressed in BCS LibertyLink@ Cotton (LLCotton25) that also confers tolerance to glufosinate ammonium herbicides.

Coordinated Framework Review Food andDrugAdministration

TwinLinkTM Cotton (events T304-40 x OHB119) is within the scope ofthe 1992 FDApoHcy statementconcerning regulation ofproducts derived from new plant varieties, including those developed through biotechnology (US-FDA, 1992). BCS has provided the FDA with information on the identity, function, and characterization ofthe genes, for TwinLinkTM Cotton, including expression ofthe gene products. The FDA is currently reviewing the information submitted by the applicant.

APHIS considers the FDA food and feed safety and nutritional assessment determination when assessing potential impacts that may result from a determination ofnonregulated status ofa OE organism. In the absence ofa completed FDA determination, APHIS takes into consideration prior FDAreviews ofcomparable products to make a preliminary assessment ofthe potential impacts. Note that with regard to the expression ofglufosinate ammonium tolerance, the gene construct in the BayerTwinLinkTM Cotton is the same as that approved bythe FDA in June 2003 for the LibertyLink@ Cottonproduct (US-FDA, 2003). In that approval, the FDA noted that the transformational event in LibertyLink@ Cotton was not materially different in composition, safety, orany otherrelevant parameter in cotton grown, marketed, and consumed at that time (US-FDA, 2003). This previous FDA review was usedby APHIS to analyze the food and safety impacts associated with the incorporation and expression ofglufosinate ammonium tolerance in TwinLinkTM Cotton. The FDA's oversight ofthe food and safety impacts associated with the incorporation and expression ofpesticidal substances, in this case, the Cryproteins associated with Bt, are more limited. EPA is theprimary authority for the review ofplant-incorporated protectants.

EnvironmentalProtectionAgency

The EPA has authority overthe use ofpesticidal substances and plant-incorporated protectants under the FIFRA as amended (7 USC §136, et seq.) and the FFDCA (21 USC §301, etseq.). EPA is currently reviewing information submitted by the applicant on the efficacy and potential environmental concerns associated with the use ofTwinLinkTM Cotton.

API-lIS considers the EPA's regulatory assessment when assessing potential impacts that may result from a determination ofnonregulated status ofa OE organism. In the absence ofa completed EPA determination, APHIS takes into consideration prior EPA reviews ofcomparable

4products to make a preliminary assessment ofthe potential impacts. Note that EPA has issued a tolerance exemption for CrylAbprotein in all crops (40 CFR §174.511; US-EPA, 201Oa), 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, 20lOb). These previous EPA reviews were used byAPHIS to analyze the food and safety impacts associated with the incorporation and expression ofthe Cryproteins in TwinLinkTM Cotton.

In addition to review ofthe crop withplant-incorporated protectants, EPA has authority under FIFRA to establish pesticide use restrictions; these use restrictions are presented on pesticide labels which are prepared during thepesticideregistration process. The development ofa transformed cotton cropproviding tolerance to glufosinate ammonium may require a change in the EPA-approved label for this herbicide. Thecurrent 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). Olufosinate ammonium-tolerant cotton was first available in the U.S. with the introduction ofLibertyLink® Cotton in 2004. Although the glufosinate ammonium tolerance trait expressed in TwinLinkTM cotton is the same as that expressed in the LibertyLink® Cotton, the EPA is expected to publish a
newlabel for glufosinate ammonium that also references the TwinLinkTM product varieties. APHIS used the currentglufosinate label as the basis for its evaluation ofthe potential impacts associated with the use ofand exposure to glufosinate ammonium.
Scopeofthe Environmental Analysis Although a determination ofnonregulated status ofTwinLinkTM Cotton would allow for new plantings ofTwinLinkTM Cotton to occuranywhere in the U.S., APHIS primarilyfocused the environmental analysis to those geographic areas thatcurrently support cottonproduction. A determination ofnonregulated status ofTwinLinkTM Cotton is not expected to increase cotton production, eitherby its availability alone oraccompanied byother factors, orcause an increase in overall OE cotton acreage. Todetermine 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 20 10). Cotton was produced in I 7 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 On June 28, 2011, APHIS published a notice in the Federal Register (76 FR37769-37770, Docketno. APHIS-2010-0102) announcing the availability ofthe BayerCropScience petition, and the APHIS PPRA and draft EA for a 60-day public review and commentperiod. Comments were required to bereceived on orbefore August 29,2011. All comments were carefully analyzed to identifynew issues, alternatives, or information. A total of2 commentresponses
were received from individuals during the comment period. Nonew issues, alternatives or substantive new information wereidentified in any ofthe comments received byAPHIS. The 2 comments expressed opposition to a determination ofnonregulated status ofTwinLinkTM Cotton, butdid notchange the analysis provided in the PPRA or draft EA. 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 genetically modified organisms (OMOs) orOE crops. Otherclaims suggesta negative impact of

5GE cotton and GE plants on human 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. Comment documents may be viewed at http://\Y\1vw.regulations.gov/#!searchResults:dct==PS;rpp=1 0;po=:Q;s=aphis-20 10-0102
Major Issues Addressed in the EA The issues considered in the EA were 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 particularEA, 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 otherenvironmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well as those issues that have beenraised by various 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 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):
Management Considerations

• Acreage and Areas ofCotton 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

• Animal Feed

Socioeconomic Considerations

• Domestic Economic Environment

• Trade Economic Environment

6• Social Environment



### Alternatives that were fully analyzed The EA analyzes the potential environmental consequences ofa deteImination ofnonregulated status ofTwinLinkTM Cotton. To respond favorably to a petition for nonregulated status, APHIS must deteImine that TwinLinkTM Cotton is unlikely to pose a plantpestrisk. Based on its Plant Pest Risk Assessment (USDA-APHIS, 2010) APHIS has concluded that TwinLinkTM Cotton is unlikely to pose a plantpestrisk. Therefore, APHIS must deteImine that TwinLinkTM Cotton is no longer subject to 7 CFRpart 340 orthe plant pest provisions ofthe Plant Protection Act. Two alternatives were evaluated in the EA: 

### (1) no action and (2) deteImination of nonregulated 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 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 CFRPart 340. PeImits 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 ifthere were insufficient evidence to demonstrate the lack ofplant pest risk from the unconfined cultivation ofTwinLinkTM Cotton.

This alternative is not the Preferred Alternativebecause APHIS has concluded through a Plant Pest Risk Assessment (USDA-APHIS, 2010) that TwinLinkTM Cotton is unlikelyto pose a plant pestrisk. Choosing this alternative would not satisfy the purpose and need ofmaking a deteImination ofplant pestrisk status andresponding to the petition for nonregulated status.



### PreferredAlternative: Determination thatTwinLinkTMCotton is No Longer a Regulated Article Under this alternative, TwinLinkTM Cotton and progeny derived from them would no longerbe regulated articles underthe regulations at 7 CFRPart 340. TwinLinkTM Cotton is unlikely to pose a plantpestrisk (USDA-APHIS, 20I0). PeImits issued ornotifications acknowledged by APHIS would no longerbe required for introductions ofTwinLinkTM Cotton andprogeny derived from this event. This alternative bestmeets the agency's purpose andneedto respond appropriately to a petition for nonregulated status based on the requirements in 7 CFRpart 340 and the agency's authority under the plant pestprovisions ofthe Plant Protection Act. Because the agency has concluded that TwinLinkTM Cotton is unlikely to pose a plantpestrisk, a deteImination ofnonregulated status ofTwinLinkTM Cotton is a responsethat is consistentwith the plantpest provisions ofthe PPA, the regulations codified in 7 CFRpart 340, andthe biotechnology regulatorypolicies in the Coordinated Framework. Underthis alternative, growers mayhave future access to TwinLinkTM Cotton and progeny derived from this event if the developer decides to commercializeTwinLinkTM Cotton.



### Alternatives Considered butRejected from FurtherConsideration APHIS assembled a list ofalternatives that mightbe considered for TwinLinkTM Cotton. The agency evaluated these alternatives, in light ofthe agency's authorityunder the plantpest

7provisions ofthe 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 brieflybelow along with the specific reasons for rejecting each.



### Prohibitany TwinLinkTM Cotton from being released In response to public comments that stated a preference that no GE organisms enterthe marketpJace, APHIS considered prohibiting the release ofTwinLinkTM 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 plantpest risk**(USDA~APHIS,** 2010).

In enacting the Plant Protection Act, Congress found that
[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 Vv'bite House Emerging Technologies Interagency Policy Coordination Committee developed broadprinciples, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemergingtechnologies (such as genetic engineering) at the agency leve1. 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 emergingtechnologies:
"[DJecisions 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 our Plant Pest Risk Assessment (USDA-APHIS, 2010) and the scientific data evaluated therein, APHIS has concluded that TwinLinkTM Cotton is unlikely to pose aplant pest risk. Accordingly, there is no basis in science for prohibiting the release ofTwinLinkTM Cotton.


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

or in part." Forexample, a determination ofnonregulated status in part may be appropriate if there is aplant pest risk associated with some, but not all lines described in apetition. Because APHIS has concluded thatTwinLinkTM Cotton is unlikely to pose a plantpest risk, there is no regulatory basis under the plant pestprovisions ofthe Plant Protection Act for considering approval ofthe petition only in part.



### Isolatioll distallce betweell TwinLinkTMCotton alldnon-GE COttOIl 

### andgeographical restrictions In response to public concerns ofgene movement between GE and non-GE plants, APHIS considered requiring an isolation distance separatingTwinLinkTM Cotton from non-GE cotton production. However, because APHIS has concluded that TwinLinkTM Cotton is unlikely to
8

### pose a plant pestrisk (USDA-APHIS, 2010), an alternative based on requiring isolation distances would be inconsistent with the statutory authority underthe plantpest provisions ofthe Plant Protection Act and regulations in 7 CFRpart 340.

APHIS also considered geographically restricting the production ofTwinLinkTM Cotton based on the location ofproduction ofnon-GE cotton in organic production systems inresponse to public
concerns regarding possible gene movement between GE and non-GE plants. However, as presented in APHIS' plantpest risk assessment for TwinLinkTM Cotton, there are no geographic differences associated with any identifiable plant pest risks for TwinLinkTM Cotton (USDAAPHIS, 20 10). This alternative was rejected and not analyzed in detail because APHIS has concluded that TwinLinkTM Cotton does not pose aplant pestrisk, and will not exhibit a greater plant pestrisk in any geographically restricted area. Therefore, such an alternative would not be consistent with APHIS' statutory authorityunder the plantpest provisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnologyregulatory policies embodied in the Coordinated Framework.

Based on the foregoing, the imposition ofisolation distances orgeographic restrictions would not meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFRpart 340 and the agency's authority under the plantpest provisions ofthe PlantProtection Act. Nevertheless, APHIS is not expecting significant effects. However, individuals might choose on theirown to 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.
RequirementofTesting For TwinLinkTMCotton 

### During the commentperiods for otherpetitions 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, orlimits ofGE material in non-GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, becauseTwinLinkTM Cotton does not pose a plant pest risk (USDA-APHIS, 2010), the imposition ofany type oftesting requirements is inconsistent with the plantpest provisions ofthe 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 ofAPHIS' Selected Action The 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 in the Environmental Consequences section ofthe EA.

9,

Attribute/Measure AlternativeA: NoAction AlternativeB: Determination of Nonregulated Status Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied**~** risk assessment (USDA-APHIS, 2010) Management Practices

Acreage and Areas ofCotton Production Cropping Practices Seed Production Organic Farming Specialty Cotton Production Physical Environment Water Resources Soil Air Quality Climate Change Animal and Plant Communication Animals

Plants Biological Diversity Gene Movement Public Health Human Health Worker Safety Animal Feed Socioeconomic Issues Domestic Economic Environment Trade Economic Environment Social Environment Other Cumulative Effects Threatened and Endangered Species Other U.S Regulatory Approvals

Compliance with Other Laws Unchanged Unchanged Unchanged Unchanged Unchanged

Unchanged Unchanged Unchanged Unchanged

Unchanged Unchanged Unchanged Unchanged

Unchanged Unchanged Unchanged

Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged for existing nonregulated GE organisms Unchanged Unchanged Unchanged Unchanged Unchanged

Unchanged Unchanged Unchanged Unchanged

Unchanged Minimal Minimal Unchanged

Unchanged Unchanged Unchanged

Unchanged Unchanged

, Unchanged

i Unchanged !

Unchanged FDA consultation pending, EPA tolerance exemptions and conditional pesticide registrations being reviewed

CWW, CAA, EOs Fully compliant I Fully compliant
Notes: l. Unchanged

- the current conditions will not change as aresult ofthe selection ofthis alternative. 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 SignificantImpact

10 iThe analysis in the EA indicates that there will not be a significant impact, individually or cumulatively, on the quality ofthe human environment as a result ofthis proposed action. I agree with this conclusion and therefore find that an EIS 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 in which the environmental impact would occur. This action has potential to affect conventional and organic cotton production systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commoditymarkets. 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, 201Ob). A determinationofnonregulated status ofTwinLinkTM Cotton is not expectedto directly cause an increase in agricultural acreage devoted to cotton production,

orthose cotton acres devoted to GE cotton cultivation. The availability ofTwinLinkTM Cotton will notchangecultivation areas for cottonproduction in the U.S. andthere are no anticipated changes to the availability ofGE and non-GE cotton varieties on the market.
Although a determination ofnonregulated statusofTwinLinkTM Cotton wouldallowfor new plantings ofTwinLinkTM Cottonto occuranywhere inthe U.S., APHIS primarily focused the environmental analysis to those geographic areas that currently supportcottonproduction. A determination ofnonregulated status ofTwinLinkTM Cotton is not expected to increase cotton production, eitherby its availability alone or accompanied by other factors, orcause an increase in overall GE cotton acreage. 

### Intensity

- Intensity is a measure ofthe degree or severity ofan impactbasedupon the ten factors. The following factors were used as a basis for this decision:



### 1. Impacts that may beboth beneficialandadverse. A determination ofnonregulated status ofTwinLinkTM Cotton will have no significant environmental impact in relation to the availability ofGE, conventional, organic or specialty cotton varieties. As discussed in Chapter4 ofthe EA, a determination of nonregulated status ofTwinLinkTM Cotton is notexpectedto directly cause anincrease in agricultural acreage devoted to cotton production, orthose cotton acres devoted to GE cotton cultivation. The availability ofTwinLinkTM Cotton will not change cultivation

areas for cottonproduction in the U.S. and there areno anticipated changes to the availability ofGE andnon-GE cotton varieties on the market. A determination of nonregulated status ofTwinLinkTM Cotton could addanother GEcotton variety to the conventional cottonmarket and is not expected to change the market demands for GE cotton or cottonproduced using organic methods or specialty systems. Mostofthe cotton acreage in the U.S. is plantedto 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%washerbicide-tolerant (USDA-ERS, 2010a, 201Ob). Basedupon recent trend 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]2 GE cotton events or lines were no longer subject to the plant pest provisions ofthe PlantProtection Act and 7 CFRpart

11340, the acreage associated with the organic production ofcotton remained at slightly above 15,000 acres (USDA-ERS, 2010c). Based on the data provided by BCS for TwinLinkTM Cotton (Bayer, 20I0), as well as previous experience with other Btcotton varieties that have been widely adopted by growers since their introduction in 1996 (USDA-ERS, 2010a), APHIS has concluded that the availability ofTwinLinkTM Cotton would not alter the agronomic practices, locations, and seed production and quality characteristics ofconventional and GE seed production (USDA-APHIS, 2010). A determination ofnonregulated status ofTwinLinkT:'>1 Cotton will not require a change to seed production practices. A detennination ofnonregulated status ofTwinLinkTM Cotton is not expected to result in changes in the current cotton cropping practices. As discussed in Chapter4 ofthe EA, studies demonstrate TwinLinkTM Cotton is essentially indistinguishable from other cotton varieties used in terms ofagronomic characteristics and cultivation practices (Bayer, 20I0). IfTwinLinkTM Cotton is adopted, a continued reduction in the use ofbudworrnlbollworm insecticides applications and the number of acre-treatments peryear as reported in Benbrook's trend analysis (Benbrook, 2009) is expected to occur. A determination ofnonregulated status ofTwinLinkTM Cotton will provide growers with another alternative Bt cotton variety to cultivate. Herbicide use patterns have the potential to change as well. The introduction ofTwinLinkTM Cotton provides a stacked variety, expressing Bt-based lepidopteran resistance combined with tolerance to glufosinate ammonium, an alternative herbicide. TwinLinkTM Cotton 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 glyphosateresistant 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 ofthose other herbicides needed to manage glyphosate-resistant weeds. 

### 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofTwinLinkTM Cotton would have no significant impacts onhuman or animal health. As discussed in Chapter4 ofthe EA, similar products were no longer subject to the plantpest provisions ofthe Plant Protection Act and 7 CFRpart 340 beginning in 1996 with the introduction ofBt products and followed shortly after by the introduction ofthe 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 ofthese 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 ofhuman health impacts. Based onthe analysis of field and laboratory data and scientific literature provided by BCS (Bayer, 20 10), and safety data available on other GE cotton, APHIS has concluded that a determination of nonregulated status ofTwinLinkTM Cotton would have no adverse impacts on human or animal health. 

### 3. Unique characteristics of the geographic area such asproximity to historic orcultural resources,park lands, prime farmlands, wetlands, wildandscenic rivers, orecologically 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

12

### adversely impacted by a determination ofnonregulated status ofTwinLinkTM Cotton. 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 ofproperty, wildlife habitat, or landscapes; and do not involve the sale, lease, ortransfer ofownership ofany property. This action is limited to a determination ofnonregulated status ofTwinLinkTM Cotton. The product will be deployed on agricultural land currently suitable for production of cotton and is not expected to increase the acreage ofcotton 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 ofplants would be used on agricultural landsplanted to TwinLinkTM Cotton, 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. In the event ofa determination ofnonregulated status of TwinLinkTM Cotton, the action is not likely to affect historic orcultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas thatmaybe in closeproximity to cotton production sites. 

### 4. The degree to which the effects on the quality of the human environmentare likely to be highly controversial. The effects on the quality ofthe human environment from a determination of nonregulated status ofTwinLinkTM Cotton are not highly controversial. Although there is some opposition to a determination ofnonregulated status ofTwinLinkTM Cotton, this action is not highly controversial in terms ofsize, nature or effect onthe natural or physical environment. As discussed in Chapter 4 ofthe EA, a determination of nonregulated status ofTwinLinkTM Cotton is not expected to directly cause anincrease in agricultural acreage devoted to cotton production, or those cotton acres devoted to GE cotton cultivation. The availability ofTwinLinkTM Cotton 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. TwinLinkTM Cotton is not expected to increase the total acreage ofcotton production orcurrent cotton cropping practices. 

### Itis anticipated that the trend ofreduced broad-spectrum insecticide use by cotton growers will continue due to the adoption ofBtcotton and other cultural practices. There is the potential that the introduction ofglufosinate 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 ofsome ofthe otherherbicides which have been required in response to the emergence ofglyphosate-resistant weeds. The effect ofTwinLinkTM Cotton on wildlife orbiodiversity is no different than that ofother GE ornon-GE cotton produced in conventional agriculture in the U.S. Although TwinLinkTM Cotton does provide the growerwith a new choice for a herbicide-tolerant and insect-resistant variety, cultivation ofTwinLinkTM Cotton does not otherwiserequire a change in the rates offertilizer application, tillage, planting, orharvesting from existing commercial cotton varieties, including otherGE cotton varieties providing either insect resistance, herbicide tolerance,
or stacked with both (Bayer, 2010). During the public comment period, APHIS received comments opposing a determination ofnonregulated status ofTwinLinkTM Cotton. No
new issues, alternatives or substantive new information were identified in any ofthe

13comments 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 ofGE cotton and GE plants on human health and environmental safety in a general nature. Overall, peoplewho expressed their opposition to a determination of nonregulated status did notprovide any supporting evidence for their claims. 5. The degree to which thepossible effects on the human environment are highly uncertain

or involve unique or unknown risks. Based on the analysis documented in the EA the possible effects on the human environment are well understood. The effects ofthe proposed activities are not highly uncertain and do not involve unique orunknown risks onthe natural orphysical environment. As discussed in Chapter 4 ofthe EA, a detennination ofnonregulated status ofTwinLinkTM Cotton is not expectedto directly cause an increase in agricultural acreage devoted to cotton production, orthose cotton acres devoted to GE cotton cultivation. A detennination ofnonregulated status ofTwinLinkTM Corton is not expected to result in changes in the current cotton cropping practices. BCS' studies demonstrate TwinLinkTM Cotton is essentially indistinguishable from othercotton varieties used in terms ofagronomic characteristics and cultivation practices (Bayer, 2010; USDA-APHIS, 2010). Although TwinLinkTM Cotton does provide the grower with a new choice for a herbicide-tolerant and insect-resistant variety, cultivation of TwinLinkTM Cotton does not otherwise require a change in the rates offertilizer application, tillage, planting, orharvesting 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 thatthe trend ofreduced broadspectrum insecticide use bycotton growers will continue due to the adoption ofBtcotton 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, thereby reducing the use ofsome ofthe other herbicides which have been required in response to the emergence ofglyphosate-resistant weeds. The effect ofTwinLinkTM Cotton onwildlife orbiodiversity is no different than that ofother GE or non-GE cotton produced in conventional agriculture in the U.S. As described in Chapter 4 ofthe 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), TwinLinkTM Cotton, or produce cottonusing 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 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 miIlion acres) were GE cotton. Of this, 73% ofthe GE cotton acreage was GE insect-resistant (Bt) cotton and 78% was herbicide-tolerant (USDA-ERS, 201Oa, 20l0b). Based upon historic trends, conventional production practices that use GE varieties will likely continue to dominate in terms of acreage with orwithout a determination ofnonregulaled status ofTwinLinkTM Cotton.

14Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use ofGE cotton products, the possible effects to the human environment from the release ofa an additional GE cottonproduct are already well known and understood. Therefore the impacts are nothighly 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 abouta future consideration. A determination ofnonregulated status ofTwinLinkTM Cotton would not establish a precedent for future actions with significant effects orrepresent a decision in principle about a future decision. Similarto pastregulatory requests reviewed and approved by APHIS, a determination ofnonregulated status will be based upon an independent determination on whether an organism is unlikelyto pose a plantpestriskpursuant to the regulatory requirements of7 CFRpart 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes this independentreview to determine ifthe regulated article poses a plantpestrisk. Underthe authority ofthe plantpestprovisions ofthe Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the safe development and use ofGE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as TwinLinkTM Cotton. When a petition for nonregulated status is submitted, APHIS mustmake a determination ifthe GE organism is unlikely to pose a plantpest risk. IfAPHIS determines based on its Plant PestRisk Assessment that the genetically engineered organism is unlikely to pose a plantpestrisk, the genetically engineered organism is no longer subjectto the plantpestprovisions of the Plant Protection Actand 7 CFRpart 340. APHIS regulations at7 CFRpart 340, which were promulgated pursuant to authority granted bythe Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstatemovement, 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 CFR340.2) and is also considered a plantpest. A GE organism is also regulated underPart 340 when APHIS has reason to believe that the GE organism maybe a plantpest or APHIS does nothave information to determine ifthe GE organism is unlikely to pose a plantpestrisk. A person maypetition the agencythat a particularregulated article is unlikelyto pose a plantpestrisk, and, therefore, is no longerregulated under the plantpestprovisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. The petitioneris required to provide information under § 340.6(c)(4)related to plantpestrisk thatthe agency may use to determine whetherthe regulated article is unlikely to present a greaterplantpest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of7 CFRpart 340 orthe plantpestprovisions ofthe Plant Protection Act when APHIS determines that it is unlikelyto pose a plantpestrisk. 

### 7. Whether the action is relatedto other actions with individually insignificant but cumulatively significant impacts. No significant cumulative effects were identified through this assessment. The EA discussed cumulative effects on cotton managementpractices, human and animal health, and the environment and concluded that such impacts were not significant. A cumulative

15effects analysis is included for each environmental issue analyzed in Chapter 4 ofthe EA. In the event ofa determination ofnonregulated status, TwinLinkTM Cotton may be stacked (combined) with non-GE and GE cotton varieties by traditional breeding techniques, resulting in a plantthat, for example, may also be resistant to other herbicides, ormay present a different combination ofinsect pest-resistant, but may also have progeny with no transgenes at all. There is no guarantee that TwinLinkTM Cotton will be stacked with any particularnon-GE orGE cotton varieties that are no longer subject to the plantpest provisions ofthe Plant Protection Act and 7 CFR part 340, as company plans and market demands playa significant role in those business decisions. Thus, predicting all potential combinations ofstackedvarieties that could be created using both non-GE and GE cotton varieties that are no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340 is hypothetical and purely speculative. 

### In the event ofa determination ofnonregulated status ofTwinLinkTM Cotton, APHIS has not identified any significant impact on the environment which may result from the incremental impact ofa determination ofnonregulated status of TwinLinkTM Cotton when added to otherpast, present, and reasonably foreseeable future actions. 8. The degree to which the action mayadversely affect districts, sites, highways, structures,
orobjects listed in oreligible for listing in theNational Registerof Historic Places or may cause loss ordestruction of significant scientific, cultural, or historical resources. A determination ofnonregulated status ofTwinLinkTM Cotton is not expectedto adversely impact cultural resources on tribal properties. Any farming activity 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 conflictwith cultural resources on tribal properties. A determination ofnonregulated status ofTwinLinkTM Cotton 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 ordestruction ofsignificant scientific, cultural, or historical resources. This action is limited to a determination ofnonregulated status ofTwinLinkTM Cotton. Standard agricultural practices for landpreparation, planting, irrigation, and harvesting ofplants would be used

on agricultural lands planted to TwinLinkTM Cotton, 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 ofTwinLinkTM Cotton is not an undertaking that may directly or indirectly cause alteration in the character or use ofhistoric properties protected under the National Historic Preservation Act. In general, common agricultural activities conducted under this action do nothave 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 ofa historic property when common agricultural practices, such as the operation oftractors and other mechanical equipment, are conducted close to such sites. Abuilt-in mitigating factor for this issue is that virtually all ofthe methods involved would only have temporary effects on the audible nature ofa site and can be ended at any time to restore the audible qualities ofsuch 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 ofTwinLinkTM

16Cotton does not inherently change any ofthese agronomic practices so as to give rise to
an impact underthe NHPA. 

### 9. The degree to which the action mayadversely affect an endangered orthreatenedspecies

or its habitat that has been determined to be critical under the EndangeredSpeciesActof 1973. As described in Chapter 4 ofthe 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 andhabitatproposed for designation, as required under Section 7 ofthe Endangered Species Act. Afterreviewingpossible effects ofa determination of nonregulated status ofTwinLinkTM Cotton, APHIS has reached a conclusion that a determination ofnonregulated status would have no effecton federally listed threatened

or endangered species and species proposed for listing, or on designated critical habitat or habitat proposed for designation. 

### 10. Whether the action threatens a violation of Federal, State, orlocal law or requirements imposed for theprotection of the environment. The proposed action would be in compliance with all federal, state, and local laws. Because the agencyhas concluded that TwinLinkTM Cotton is unlikely to pose a plant pestrisk, a determination ofnonregulated status ofTwinLinkTM Cotton is a response that is consistent with the plant pestprovisions ofthe PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatorypolicies in the Coordinated Framework. TwinLinkTM Cotton (events T304-40 x GHB 119) is within the scope ofthe 1992 FDA policy statement concerning regulation ofproducts derived from new plantvarieties, including those developed throughbiotechnology (US-FDA, 1992). Bayerhas provided the FDA with information on the identity, function, and characterization ofthe genes, for TwinLinkTM Cotton, including expression ofthe geneproducts. EPA has authority over the use ofpesticidal substances and plant-incorporated protectants underthe FIFRA as amended (7 USC §136, 

### etseq.) and the FFDCA (21 USC §301, 

### et seq.). EPA is currently" reviewing information submittedby the applicant on the efficacy and potential environmental concerns associated with the use ofthis product. There are no other Federal, state, orlocal permits that are neededpriorto the implementation ofthis action.



### NEPA Decision and Rationale I have carefully reviewed the EAprepared for this NEPA determination and the input from the public involvementprocess. Ibelieve that the issues identified in the EA are best addressed by selecting Alternative 2 (Determination that TwinLinkTM Cotton is No Longer a Regulated Article). This alternative meets APHIS' purpose and need to allow the safe development and use ofgenetically engineered organisms consistentwith the plantpest provisions ofthe 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 otherfactors." The preferred alternative has been selected for implementation based on consideration ofa numberofenvironmental, regulatory,

17and social factors. Based upon our evaluation and analysis, Altemative 2 is selected because (1) it allows APHIS to fulfill its statutory mission to protect America's agriculture and environment using a science-based 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 TwinLinkTM Cotton, the continued regulated status ofTwinLinkTM Cotton would be inconsistent with the plant pest provisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnology regulatorypolicies in the Coordinated Framework. Forthe reasons stated above, Ihave determined that a determination ofnonregulated status ofTwinLinkTM Cottonwill not have any significant environmental effects.

Michael 

### C. Gregoire Date: Deputy Administrator Biotechnology Regulatory Services Animal and Plant Health Inspection Services U.S. Department ofAgriculture

Literature Cited:
Bayer (2010). Petition for Determination ofNonregulated Status for Insect-Resistant and Glufosinate Ammonium-Tolerant Cotton: TwinLinkTM Cotton (Events T304-40 x GHB 119). Submitted by AL Scott, Regulatory Affairs Manager. Bayer CropScience LP (See Table**http:Uw~~Y.dPhis.usd'!.:Z9v/biotechnology/nOlJ:9.g.htJIlll .**  BCS (2010). Ignite® 280 SL Herbicide Label Bayer Crop Science. Retrieved January 2,2011 from http://fsl.agrian.com/pdfs/Ignite 280 SL Herbicide Labe13.pdf
Benbrook, C. (2009). Impacts ofGenetically Engineered Crops on Pesticide Use in the United States: The First Thirteen Years, The Organic Center: 69.

USDA-APHIS (2010) Determination ofPlant Pest Risk for Insect-Resistant and Glufosinate Ammonium-Tolerant (TwinLinkTM) Cotton, Gossypium hirsutum, events T304-40 x GHBI19. Retrieved from http://www.aphis.usda.govlbiotechnology/not_reg.html

US-EPA. (2010a) Bacillus thuringiensis CrylAb Protein in all Plants; Exemption from the Requirement ofa Tolerance, 40 CFR §174.511.

US-EPA. (201Ob) Bacillus thuringiensis Cry2Ae Protein in Cotton; Temporary Exemption from the Requirement ofa Tolerance, 40 CFR §174.530

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### US-EPA. (20IOc) Phosphinothricin Acetyltransferase (PAT): Exemption from the Requirement ofTolerance. 40 CFR §174.522, first published at 40 CFR §180.1151.

USDA-ERS (20IOa). Adoption ofGenetically Engineered Crops in the U.S. Economic Research Service. Retrieved November 2,2010 from http://www.ers.llsda.gov/data/BiotechCrops/

USDA-ERS (20lOb). Adoption ofGenetically Engineered Crops in the U.S.: Upland Cotton Varieties Economic Research Service. Retrieved December 3,2010 from http://www.ers.usda.govlData/BiotechCropslExtentofAdoptionTable2.htm

USDA-ERS (20IOc). Table 3--Certified Organic and Total U.S. Acreage, Selected Crops and Livestock, 1995-2008 Economic Research Service. Retrieved November 5, 2010 from http://www.ers.tJsda.gov/DatalOrganic/

US-FDA (1992). Statement ofPolicy

- Foods Derived from New Plant Varieties. Retrieved January 18, 2011 from http://wvvw.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Biot echnology/ucm096095.htm

US-FDA (2003). Biotechnology ConsultationNote to the File BNF No. 000086 Retrieved October 14, 

### 2010 from http://www.fda.gov/Food/Biotechnology/Submissions/ucm155782.htm

USDA-NASS (2007). 2007 Census ofAgriculture: Cotton Industry Retrieved November 5, 2010 from http://www.agcensus.usda.gov/PublicationsI2007/0nline HighlightslFact Sheets/cotton.pdf

USDA-NASS (2010). 2010 Upland Cotton Harvested Areas National Agriculture Statistics Service Board. Retrieved November 2, 2010 from http://www.nass.usda.gov/Charts and Maps/graphics/cotnacm.pdf

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