NATIONAL ENVIRONMENTAL POLICY ACT DECISION 


AND 


FINDING OF NO SIGNIFICANT IMPACT 


Bayer CropScience 


Insect Resistant and Glufosinate Ammonium-Tolerant 


(TwinLinkTM) Cotton, Events T304-40 x GHBl19 


United States Department of Agriculture 


Animal and Plant Health Inspection Service 


Biotechnology Regulatory Services 


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

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

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

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' NEP A 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 CFR part 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 of a petition request (APHIS Number 08-340-01 p) 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 GHB 119), BCS has developed a cotton resistant to lepidopteran pests. The TwinLinkTM 

Cotton also expresses a glufosinate ammonium herbicide tolerance trait based on LibertyLink@ 

technology. This EA has been prepared in order to specifically evaluate the effects on the 

quality of the human environment I that may result 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 of APHIS. APHIS provides leadership in 

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

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

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

, Under NEPA regulations, the "human environment" includes "the natural and physical environment and the 

relationship of people with that environment" (40 CFR §50S.14). 

1 
genetically 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 of Science and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

products and explains how federal agencies will use existing Federal statutes in a manner to 

ensure public health and environmental safety while maintaining regulatory flexibility to avoid 

impeding the growth of the biotechnology industry. The Coordinated Framework is based on 

several important guiding principles: (1) agencies should define those transgenic organisms 

subject to review to the extent permitted by their respective statutory authorities; (2) agencies are 

required to focus on the characteristics and risks of the biotechnology product, not the process by 

which it is created; (3) agencies are mandated to exercise oversight 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's APHIS, the Food and Drug 

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

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

the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment. 

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

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

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

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

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

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

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

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

on .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 other regulatory 

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

The EPA regulates plant-incorporated protectants under the F ederallnsecticide, Fungicide, and 

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

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

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

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

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

an organism through techniques of modern 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 of GE organisms. APHIS regulations at 7 Code of 


Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by 


the Plant Protection Act, as amended (7 United States Code (U.S.c.) 7701-7772), regulate the 


introduction (importation, interstate movement, or release into the environment) of certain GE 


organisms and products. A GE organism is no longer subject to the plant pest provisions of the 


Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 


determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 


article if the donor organism, recipient organism, vector, or vector agent used in engineering the 


organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered 


a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe 


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


the GE organism is unlikely to pose a plant pest risk. 


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


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


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


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


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


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


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


plant pest risk. 


APHIS' Response to Petition for Nonregulated Status 


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


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


by 7 CFR 340.6, APHIS must respond to petitioners who request a determination of the 


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 unlikely to pose a plant pest risk. IfAPHIS determines based on its Plant Pest Risk 


Assessment (PPRA) that the genetically engineered organism is unlikely to pose a plant pest risk, 


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


Protection Act and 7 CFR part 340. 


Bayer CropScience has submitted a petition (APHIS Number 08-340-01 p) to APHIS seeking a 


determination that their genetically engineered TwinLinkTM Cotton Events GHBl19 and T304­

40 are unlikely to pose a plant pest risk and, therefore, should no longer be a regulated article 


under regulations 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, 


3 

Helicoverpa zea), tobacco budworm (TBW, Heliothis virenscens), and fall armyworm (FA W, 

SpodopteraJrugiperda) which are common pests of cotton. The rationale for using two Bt genes 

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 bar gene 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 and Drug Administration 

TwinLinkTM Cotton (events T304-40 x OHB 119) is within the scope of the 1992 FDA poHcy 

statement concerning regulation of products 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 of the genes, for TwinLinkTM Cotton, 

including expression of the 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 of nonregulated status of a OE 

organism. In the absence of a completed FDA determination, APHIS takes into consideration 

prior FDA reviews of comparable products to make a preliminary assessment of the potential 

impacts. Note that with regard to the expression of glufosinate ammonium tolerance, the gene 

construct in the Bayer TwinLinkTM Cotton is the same as that approved by the FDA in June 2003 

for the LibertyLink@ Cotton product (US-FDA, 2003). In that approval, the FDA noted that the 

transformational event in LibertyLink@ Cotton was not materially different in composition, 

safety, or any other relevant parameter in cotton grown, marketed, and consumed at that time 

(US-FDA, 2003). This previous FDA review was used by APHIS to analyze the food and safety 

impacts associated with the incorporation and expression of glufosinate ammonium tolerance in 

TwinLinkTM Cotton. The FDA's oversight of the food and safety impacts associated with the 

incorporation and expression of pesticidal substances, in this case, the Cry proteins associated 

with Bt, are more limited. EPA is the primary authority for the review of plant-incorporated 

protectants. 

Environmental Protection Agency 

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

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

EP A 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 of nonregulated status of a OE organism. In the absence of a 

completed EPA determination, APHIS takes into consideration prior EPA reviews of comparable 

4 

products to make a preliminary assessment of the potential impacts. Note that EPA has issued a 

tolerance exemption for Cry lAb protein in all crops (40 CFR §174.511; US-EPA, 201Oa), as 

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

the requirement of a tolerance has been issued for Cry2Ae (40 CFR § 174.530; US-EPA, 20 lOb). 

These previous EPA reviews were used by APHIS to analyze the food and safety impacts 

associated with the incorporation and expression of the Cry proteins in TwinLinkTM Cotton. 

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

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

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

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

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

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

references products marketed under the trade name "LibertyLink" (BCS, 2010). Olufosinate 

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

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 

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

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

associated with the use of and exposure to glufosinate ammonium. 

Scope of the Environmental Analysis 

Although a determination ofnonregulated status ofTwinLinkTM Cotton would allow for new 

plantings ofTwinLinkTM Cotton to occur anywhere in the U.S., APHIS primarily focused the 

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

determination ofnonregulated status ofTwinLinkTM Cotton is not expected to increase cotton 

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

in overall OE cotton acreage. To determine areas of cotton 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 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 FR 37769-37770, 

Docket no. APHIS-20 10-0 102) announcing the availability of the Bayer CropScience petition, 

and the APHIS PPRA and draft EA for a 60-day public review and comment period. Comments 

were required to be received on or before August 29,2011. All comments were carefully 

analyzed to identify new issues, alternatives, or information. A total of 2 comment responses 

were received from individuals during the comment period. No new issues, alternatives or 

substantive new information were identified in any of the comments received by APHIS. The 2 

comments expressed opposition to a determination ofnonregulated status ofTwinLinkTM Cotton, 

but did not change the analysis provided in the PPRA or draft EA. These individuals did not 

mention their specific disagreement with APHIS' analyses of TwinLinkTM Cotton detailed in the 

EA or the PPRA (USDA-APHIS, 2010); rather, they expressed their general opposition to 

genetically modified organisms (OMOs) or OE crops. Other claims suggest a negative impact of 

5 

GE cotton and GE plants on human health and environmental safety in a general nature, Overall, 

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

any supporting evidence for their claims. 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 of the Plant 

Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a 

determination ofnonregulated status of TwinLinkTM Cotton. Issues discussed in the EA were 

developed by considering public concerns as well as issues raised in public comments submitted 

for other environmental assessments of genetically engineered organisms, concerns raised in 

lawsuits, as well as those issues that have been raised by various stakeholders. These issues, 

including those regarding the agricultural production of cotton using various production 

methods, and the environmental and food/feed safety of genetically engineered plants were 

addressed to analyze the potential environmental impacts of TwinLinkTM Cotton. 

The 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 of Cotton Production 

• Cropping Practices 

• Seed Production 

• Organic Farming 

• Specialty Cotton Production 

Environmental Considerations 

• Water Resources 

• Soil 

• Air Quality 

• Climate Change 

• Animals 

• Plants 

• Biological Diversity 

• Gene Movement 

Public Health Considerations 

• Human Health 

• Worker Safety 

• 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 of a deteImination of nonregulated 

status of TwinLinkTM Cotton. To respond favorably to a petition for nonregulated status, 

APHIS must deteImine that TwinLinkTM Cotton is unlikely to pose a plant pest risk. Based on 

its Plant Pest Risk Assessment (USDA-APHIS, 2010) APHIS has concluded that TwinLinkTM 

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

Cotton is no longer subject to 7 CFR part 340 or the 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 of the 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 CFR Part 340. PeImits issued or notifications acknowledged by APHIS would 

still be required for introductions of TwinLinkTM 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 of plant pest risk from the 

unconfined cultivation of TwinLinkTM Cotton. 

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

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

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

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

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

Article 

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

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

pose a plant pest risk (USDA-APHIS, 20 I 0). PeImits issued or notifications acknowledged by 

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

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

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

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

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

deteImination of nonregulated status ofTwinLinkTM Cotton is a response that is consistent with 

the plant pest provisions ofthe PPA, the regulations codified in 7 CFR part 340, and the 

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

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

the developer decides to commercialize TwinLinkTM Cotton. 

Alternatives Considered but Rejected from Further Consideration 

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

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

7 

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

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

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

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

rejecting each. 

Prohibit any TwinLinkTM Cotton from being released 

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

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 

plant pest risk (USDA~APHIS, 2010). 

In enacting the Plant Protection Act, Congress found that 

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

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

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

the Vv'bite House Emerging Technologies Interagency Policy Coordination Committee developed 

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

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

at the agency 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 emerging technologies: 

"[DJecisions should be based on the best reasonably obtainable scientific, technical, 

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

of each agency" 

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

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

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

Approve the petition in part 

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

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

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

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

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

approval of the petition only in part. 

Isolatioll distallce betweell TwinLinkTMCotton alld non-GE COttOIl and geographical 

restrictions 

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

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

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

8 

pose a plant pest risk (USDA-APHIS, 2010), an alternative based on requiring isolation 

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

Plant Protection Act and regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production ofTwinLinkTM Cotton based on 

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

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

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

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

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

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

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

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

Coordinated Framework. 

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

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

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

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

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

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

management practices to minimize gene movement between cotton fields. 

Requirement ofTesting For TwinLinkTM Cotton 

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

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

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

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

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

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

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

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

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

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

authorities. 

Environmental Consequences of APHIS' Selected Action 

The EA contains a full analysis of the alternatives to which we refer the reader for specific 

details. The following table briefly summarizes the results for each ofthe issues fully analyzed 

in the Environmental Consequences section of the EA. 

9 

, 

Attribute/Measure Alternative A: No Action 

Alternative B: 

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 of Cotton 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 a result of the selection of this alternative. 

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

changes, if any, are not deemed significant. 

Finding of No Significant Impact 

10 


i 
The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality of the human environment as a result ofthis proposed action. I 

agree with this conclusion and therefore find that an EIS need not be prepared. 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 

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. Of this, 73% 

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

(USDA-ERS, 2010a, 201Ob). A determination ofnonregulated status ofTwinLinkTM Cotton is 

not expected to directly cause an increase in agricultural acreage devoted to cotton production, 

or those cotton acres devoted to GE cotton cultivation. The availability of TwinLinkTM 

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. 

Although a determination ofnonregulated status ofTwinLinkTM Cotton would allow for new 

plantings ofTwinLinkTM Cotton to occur anywhere in the U.S., APHIS primarily focused the 

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

determination of nonregulated status ofTwinLinkTM Cotton is not expected to increase cotton 

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

in overall GE cotton acreage. 

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

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

1. Impacts that may be both beneficial and adverse. 

A determination ofnonregulated status ofTwinLinkTM Cotton will have no significant 

environmental impact in relation to the availability ofGE, conventional, organic or 

specialty cotton varieties. As discussed in Chapter 4 ofthe EA, a determination of 

nonregulated status ofTwinLinkTM Cotton 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 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. A determination of 

nonregulated status ofTwinLinkTM Cotton 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, 201 Ob). Based upon recent trend information, adding GE varieties to the market 

is not related to the ability of organic production systems to maintain their market 

share. Between 2000 and 2008, although] 2 GE cotton events or lines were no 

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

11 

340, the acreage associated with the organic production of cotton remained at slightly 

above 15,000 acres (USDA-ERS, 2010c). Based on the data provided by BCS for 

TwinLinkTM Cotton (Bayer, 20 I 0), as well as previous experience with other Bt cotton 

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

(USDA-ERS, 2010a), APHIS has concluded that the availability ofTwinLinkTM Cotton 

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

characteristics of conventional 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 of nonregulated status ofTwinLinkTM Cotton 

is not expected to result in changes in the current cotton cropping practices. As 

discussed in Chapter 4 of the EA, studies demonstrate TwinLinkTM Cotton is essentially 

indistinguishable from other cotton varieties used in terms of agronomic characteristics 

and cultivation practices (Bayer, 20 I 0). IfTwinLinkTM Cotton is adopted, a continued 

reduction in the use ofbudworrnlbollworm insecticides applications and the number of 

acre-treatments per year as reported in Benbrook's trend analysis (Benbrook, 2009) is 

expected to occur. A determination ofnonregulated status of TwinLinkTM Cotton will 

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

patterns have the potential to change as well. The introduction of TwinLinkTM 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 of those 

other herbicides needed to manage glyphosate-resistant weeds. 

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

A determination of nonregulated status ofTwinLinkTM Cotton would have no 

significant impacts on human or animal health. As discussed in Chapter 4 of the EA, 

similar products were no longer subject to the plant pest provisions of the Plant 

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

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

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

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

approval. The cultivation 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 of human health impacts. Based on the 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 of TwinLinkTM Cotton would have no adverse impacts on human or 

animal health. 

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

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

critical areas. 

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

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

12 

adversely impacted by a determination of nonregulated status of TwinLinkTM 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, or transfer of ownership of any property. 

This action is limited to a determination ofnonregulated status of TwinLinkTM Cotton. 

The product will be deployed on agricultural land currently suitable for production of 

cotton and is not expected to increase the acreage of cotton production. This action 

would not convert land use to nonagricultural use and therefore would have no adverse 

impact on prime farm land. Standard agricultural practices for land preparation, planting, 

irrigation, and harvesting ofplants would be used on agricultural lands planted to 

TwinLinkTM Cotton, including the use of EPA registered pesticides. Applicant's 

adherence to EPA label use restrictions for all pesticides will mitigate potential impacts 

to the human environment. In the event of a determination of nonregulated status of 

TwinLinkTM Cotton, the action is not likely to affect historic or cultural resources, park 

lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas 

that may be in close proximity to cotton production sites. 

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

highly controversial. 

The effects on the quality of the 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 of size, nature or effect on the natural or 

physical environment. As discussed in Chapter 4 of the EA, a determination of 

nonregulated status ofTwinLinkTM Cotton 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 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 of cotton production or current cotton cropping 

practices. It is anticipated that the trend ofreduced broad-spectrum insecticide use by 

cotton growers will continue due to the adoption of Bt cotton and other cultural practices. 

There is the potential that the introduction of glufosinate ammonium tolerance may result 

in a reduction in total herbicide use as growers adopt different herbicide treatment 

strategies involving glufosinate ammonium as a post-emergent crop treatment, thereby 

reducing the use ofsome ofthe other herbicides which have been required in response to 

the emergence of glyphosate-resistant weeds. The effect of TwinLinkTM Cotton on 

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

in conventional agriculture in the U.S. Although TwinLinkTM Cotton does provide the 

grower with a new choice for a herbicide-tolerant and insect-resistant variety, cultivation 

ofTwinLinkTM Cotton does not otherwise require a change in the rates of fertilizer 

application, tillage, planting, or harvesting from existing commercial cotton varieties, 

including other GE cotton varieties providing either insect resistance, herbicide tolerance, 

or stacked with both (Bayer, 2010). During the public comment period, APHIS received 

comments opposing a determination of nonregulated status of TwinLinkTM Cotton. No 

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

13 

comments received by APHIS. These individuals did not mention their specific 

disagreement with APHIS' analyses of TwinLinkTM Cotton detailed in the EA or the 

PPRA (USDA-APHIS, 2010); rather, they expressed their general opposition to 

genetically modified organisms (GMOs) or GE crops. Other claims suggest a negative 

impact of GE cotton and GE plants on human health and environmental safety in a 

general nature. Overall, people who expressed their opposition to a determination of 

nonregulated status did not provide any supporting evidence for their claims. 

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

or involve unique or unknown risks. 

Based on the analysis documented in the EA the possible effects on the human 

environment are well understood. The effects of the proposed activities are not highly 

uncertain and do not involve unique or unknown risks on the natural or physical 

environment. As discussed in Chapter 4 ofthe EA, a detennination of nonregulated 

status of TwinLinkTM Cotton is not expected to directly cause an increase in agricultural 

acreage devoted to cotton production, or those 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 other cotton 

varieties used in terms of agronomic 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 of fertilizer 

application, tillage, planting, or harvesting from existing commercial cotton varieties, 

including other GE cotton varieties providing either insect resistance, herbicide tolerance, 

or stacked with both (Bayer, 2010). It is anticipated that the trend of reduced broadspectrum insecticide use by cotton growers will continue due to the adoption ofBt cotton 

and other cultural practices. There is the potential that the introduction ofglufosinate 

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

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

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

effect of TwinLinkTM Cotton on wildlife or biodiversity is no different than that of other 

GE or non-GE cotton produced in conventional agriculture in the U.S. As described in 

Chapter 4 of the 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 cotton using organic methods or specialty 

systems, will continue to use these reasonable, commonly accepted best management 

practices for their chosen systems and varieties during agricultural cotton production. 

Additionally, most ofthe cotton acreage in the U.S. is planted to GE cotton. Of the 11.3 

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

this, 73% of the GE cotton acreage was GE insect-resistant (Bt) cotton and 78% was 

herbicide-tolerant (USDA-ERS, 201Oa, 20l0b). Based upon historic trends, conventional 

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

acreage with or without a determination ofnonregulaled status ofTwinLinkTM Cotton. 

14 

Given 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 of a an additional GE cotton product are already well known and understood. 

Therefore the impacts are not highly uncertain, and do not involve unique or unknown 

risks. 

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


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


A determination ofnonregulated status ofTwinLinkTM Cotton would not establish a 

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

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

APHIS, a determination of nonregulated status will be based upon an independent 

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

regulatory requirements of7 CFR 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 plant pest risk. Under the authority ofthe plant pest provisions 

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

Assessment that the genetically engineered organism is unlikely to pose a plant pest risk, 

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

the Plant Protection Act and 7 CFR part 340. APHIS regulations at 7 CFR part 340, 

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

amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction 

(importation, interstate movement, or release into the environment) of certain GE 

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

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

belongs to one ofthe taxa listed in the regulation (7 CFR 340.2) and is also considered a 

plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to 

believe that the GE organism may be a plant pest or APHIS does not have information to 

determine ifthe GE organism is unlikely to pose a plant pest risk. A person may petition 

the agency that a particular regulated article is unlikely to pose a plant pest risk, and, 

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

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

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

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

unmodified organism. A GE organism is no longer subject to the regulatory requirements 

of 7 CFR part 340 or the plant pest provisions ofthe Plant Protection Act when APHIS 

determines that it is unlikely to pose a plant pest risk. 

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

cumulatively significant impacts. 

No significant cumulative effects were identified through this assessment. The EA 

discussed cumulative effects on cotton management practices, human and animal health, 

and the environment and concluded that such impacts were not significant. A cumulative 

15 

effects analysis is included for each environmental issue analyzed in Chapter 4 of the EA. 

In the event of a determination of nonregulated status, TwinLinkTM Cotton may be 

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

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

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

have progeny with no transgenes at all. There is no guarantee that TwinLinkTM Cotton 

will be stacked with any particular non-GE or GE cotton varieties that are no longer 

subject to the plant pest provisions of the 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 of stacked varieties that could be created 

using both non-GE and GE cotton varieties that are no longer subject to the plant pest 

provisions of the Plant Protection Act and 7 CFR part 340 is hypothetical and purely 

speculative. In the event of a determination of nonregulated status ofTwinLinkTM 

Cotton, APHIS has not identified any significant impact on the environment which may 

result from the incremental impact of a determination of nonregulated status of 

TwinLinkTM Cotton when added to other past, present, and reasonably foreseeable future 

actions. 

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

or objects listed in or eligiblefor listing in the National Register ofHistoric Places or 

may cause loss or destruction ofsignificant scientific, cultural, or historical resources. 

A determination of nonregulated status of TwinLinkTM Cotton is not expected to 

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 conflict with cultural resources on tribal properties. 

A determination of nonregulated status of TwinLinkTM Cotton would have no impact on 

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

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

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

determination of nonregulated status of TwinLinkTM Cotton. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on agricultural lands planted to TwinLinkTM Cotton, including the use of EPA registered 

pesticides. Applicant's adherence to EPA label use restrictions for all pesticides will 

mitigate potential impacts to the human environment. A determination of nonregulated 

status ofTwinLinkTM Cotton is not an undertaking that may directly or indirectly cause 

alteration in the character or use of historic properties protected under the National 

Historic Preservation Act. In general, common agricultural activities conducted under 

this action do not have the potential to introduce visual, atmospheric, or audible elements 

to areas in which they are used that could result in effects on the character or use of 

historic properties. For example, there is potential for audible effects on the use and 

enjoyment of a historic property when common agricultural practices, such as the 

operation oftractors and other mechanical equipment, are conducted close to such sites. 

A built-in mitigating factor for this issue is that virtually all of the methods involved 

would only have temporary effects on the audible nature of a site and can be ended at any 

time to restore the audible qualities of such sites to their original condition with no 

further adverse effects. Additionally, these cultivation practices are already being 

conducted throughout the cotton production regions. The cultivation ofTwinLinkTM 

16 
Cotton does not inherently change any of these agronomic practices so as to give rise to 

an impact under the NHP A. 

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

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

1973. 

As described in Chapter 4 of the 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. After reviewing possible effects of a determination of 

nonregulated status ofTwinLinkTM Cotton, APHIS has reached a conclusion that a 

determination of nonregulated status 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. 

10. 	 Whether the action threatens a violation ofFederal, State, or local law or requirements 


imposedfor the protection ofthe environment. 


The proposed action would be in compliance with all federal, state, and local laws. 

Because the agency has concluded that TwinLinkTM Cotton is unlikely to pose a plant 

pest risk, a determination ofnonregulated status ofTwinLinkTM Cotton is a response that 

is consistent with the plant pest provisions of the PP A, the regulations codified in 7 CFR 

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

TwinLinkTM Cotton (events T304-40 x GHB 119) is within the scope of the 1992 FDA 

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

including those developed through biotechnology (US-FDA, 1992). Bayer has provided 

the FDA with information on the identity, function, and characterization ofthe genes, for 

TwinLinkTM Cotton, including expression ofthe gene products. EPA has authority over 

the use of pesticidal substances and plant-incorporated protectants under the FIFRA as 

amended (7 USC §136, et seq.) and the FFDCA (21 USC §301, et seq.). EPA is currently" 

reviewing information submitted by the applicant on the efficacy and potential 

environmental concerns associated with the use of this product. There are no other 

Federal, state, or local permits that are needed prior to the implementation ofthis action. 

NEPA Decision and Rationale 

I have carefully reviewed the EA prepared for this NEPA determination and the input from the 

public involvement process. I believe 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 consistent with the plant pest 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 other factors." The preferred alternative has been 

selected for implementation based on consideration of a number of environmental, regulatory, 

17 

and social factors. Based upon our evaluation and analysis, Al temati ve 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 of TwinLinkTM Cotton would be inconsistent with the plant pest 

provisions of the PP A, the regulations codified at 7 CFR part 340, and the biotechnology 

regulatory policies in the Coordinated Framework. For the reasons stated above, I have 

determined that a determination ofnonregulated status of TwinLinkTM Cotton will not have any 

significant environmental effects. 

Michael C. Gregoire Date: 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Services 

U.S. Department of Agriculture 

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 of Genetically Engineered Crops on Pesticide Use in the United 

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

USDA-APHIS (2010) Determination of Plant 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 of a Tolerance, 40 CFR § 174.511. 

US-EPA. (201 Ob) Bacillus thuringiensis Cry2Ae Protein in Cotton; Temporary Exemption from 

the Requirement of a Tolerance, 40 CFR § 174.530 

18 
US-EPA. (20IOc) Phosphinothricin Acetyltransferase (PAT): Exemption from the Requirement 

of Tolerance. 40 CFR § 174.522, first published at 40 CFR § 180.1151. 

USDA-ERS (20IOa). Adoption of Genetically Engineered Crops in the U.S. Economic Research 

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

USDA-ERS (20 lOb). Adoption of Genetically 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 of Policy - 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 Consultation Note 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 of Agriculture: 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 

19