NATIONAL ENVIRONMENTAL POLICY ACT DECISION 

AND 

FINDING OF NO SIGNIFICANT IMPACT 

SYNGENTA BIOTECHNOLOGY, INC. 


LEPIDOPTERAN-RESISTANT 


EVENT COT67B COTTON 


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 ofthe 

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 

(FONS!), sets forth APHIS' NEPA decision and its rationale. Comments from the public 

involvement process were evaluated and considered in developing this NEP A decision. 

In accordance with APHIS procedures implementing NEP A (7 CFR part 372), APHIS has 

prepared an Environmental Assessment (EA) to evaluate and determine if there are any 

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

status of a petition request (APHIS Number 07 -108-01 p) by Syngenta Biotechnology, Inc. 

(Syngenta) for their genetically engineered Event COT67B cotton (COT67B (OECD Unique 

Identifier SYN-IR67B-I» that expresses a CrylAb protein to protect cotton plants from 

lepidopteran insect damage. This EA has been prepared in order to specifically evaluate the 

effects on the quality of the human environment! that may result from a determination of . 

nonregulated status of COT67B cotton. The EA assesses alternatives to a determination of 

nonregulated status of COT67B 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 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 of agricultural production (conventional, organic, or the use of 

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 

I 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 

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 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 extent permitted by their respective statutory authorities; (2) agencies are 

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

which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when 

there is evidence of "unreasonable" risk. 

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

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

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

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

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

pose a plant pest risk to the environment. 

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

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

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

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

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

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

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

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

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

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

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

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

Rodenticide Act (FIFRA) and 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 ofmodern 

biotechnology. 

Regulated Organisms 

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

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

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

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 

2 

article ifthe 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 of 7 CFR part 340 or the plant 

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

plant pest risk. 

APHIS' Response to 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 ofthe 

regulated status of GE organisms, including GE plants such as COT67B cotton. When a petition 

for nonregulated status is submitted, APHIS must make a determination if the 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 of the Plant 

Protection Act and 7 CFR part 340. 

Syngenta Biotechnology, Inc. (Syngenta) has submitted a petition (APHIS Number 07-108-01p) 

to APHIS seeking a determination that their genetically engineered Event COT67B cotton is 

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

regulations at 7 CFR Part 340. 

Syngenta Lepidopteran-Resistant Event COT67B Cotton 

Syngenta has developed a new genetically engineered cotton event, COT67B cotton (OECD 

Unique Identifier SYN-IR67B-l) via recombinant DNA techniques with broad spectrum 

lepidopteran insect resistance. COT67B cotton produces a full-length CrylAb protein originally 

derived from Bacillus thuringiensis subsp. leurstald HD-l which has activity against several 

important lepidopteran pest species of cotton. These include, but are not limited to, Helicoverpa 

zea (cotton bollworm), Heliothis virescens (tobacco budworm), Pectinophora gossypiella (pink 

bollworm), and Trichoplusia ni (cabbage looper). Event COT67B, either alone or when 

combined by traditional breeding with other genetically-modified insect resistant cotton 

varieties, will provide growers with an additional pest management option for lepidopteraninsect pest control and will contribute to a reduction in the likelihood of insect resistance to Bt 

insect-resistant cotton varieties. 

Coordinated Framework Review 

3 
COT67B cotton is designed for human and animal consumption and as such, may also be subject 

to regulation by the FDA. 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 ofbiotechnology-derived food. Syngenta submitted a summary of its 

safety and nutritional assessment to FDA for COT67B cotton. Syngenta concluded that, with the 

exception ofthe intended change in fatty acid composition, the COT67B cotton and the foods 

and feeds derived from it are no different in composition, safety, or any other relevant parameter 

from cotton now grown, marketed, and consumed (Syngenta 2007). In February 2009, FDA 

completed Syngenta's consultation on COT67B cotton regarding the safety and nutritional 

assessment for the cotton and had no further questions (US-FDA No.000112). To view the text 

ofthe FDA's scientific and regulatory assessment response for COT67B cotton refer to 

Appendix A ofthe EA or 

http://www.accessdata.fda.gov/scripts/fcnlfcnNavigation.cfin?rpt:::;bioListing&page=1. 

Tolerance exemptions and conditional pesticide registrations have been granted for the plantincorporated protectant in COT67B cotton and the genetic material necessary for its production. 

On July 16,2008, the EPA granted an exemption from the requirement of a tolerance for 

residues ofFLCrylAb in or on food and feed commodities of cotton (73 FR 40760-40764). 

Likewise, on October 29,2008, EPA approved the conditional registration ofFLCrylAb 

produced in COT67B cotton for use as a lepidopteran insecticide (73 FR 64323-64324) (USEPA 2008). 

Scope of the Environmental Analysis 

Although a determination ofnonregulated status ofCOT67B cotton would allow for new 

plantings ofCOT67B 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 ofCOT67B 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. 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 2010). Cotton was produced in 17 states 

including Alabama, Arizona, Arkansas, California, Florida, Georgia, Kansas, Louisiana, 

Mississippi, Missouri, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, 

Texas, and Virginia. 

Public Involvement 

On May 11,2011, APHIS published a notice in the Federal Register (76 FR 27301-27303, 

Docket no. APHIS-2007-0130) announcing the availability ofthe Syngenta 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 July 11, 2011. All comments were carefully analyzed to 

identify new issues, alternatives, or information. A total of7 comment responses were received 

from various groups and individuals during the comment period. An additional 4,045 names 

were submitted as an attachment to one ofthe comment documents. No new issues, alternatives 

or substantive new information were identified in any ofthe comments received by APHIS. The 

7 comments expressed opposition to a determination of nonregulated status ofCOT67B 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 COT67B cotton detailed in the EA 

4 

or the PPRA (USDA-APHIS 2009); 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, people 

who expressed their opposition to a determination ofnonregulated status did not provide any 

supporting evidence for their claims. In addition, a single public comment generally claimed that 

the draft EA was inadequate. However, no explanation was provided for this reasoning. 

Responses to substantive comments are included as an attachment to this Finding ofNo 

Significant Impact. 

Major Issues Addressed in the EA 

The issues considered in the EA were developed based on APHIS' determination to that certain 

genetically engineered organisms are no longer subject to the plant pest provisions ofthe Plant 

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

determination ofnonregulated status of COT67B 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 ofgenetically 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 ofcotton using various production 

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

addressed to analyze the potential environmental impacts ofCOT67B 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 Use 

• 	 Soil 

• 	 Air Quality 


Climate Change 
 • 

• 	 Animals 


Plants
 • 

• 	 Biological Diversity 

• 	 Gene Movement 

Public Health Considerations 

• 	 Human Health 

• Worker Safety 

• 	 Animal Feed 

5 

Socioeconomic Considerations 

• Domestic Economic Environment 

• Trade Economic Environment 

• Social Environment 

Alternatives that were fully analyzed 

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

status of COT67B cotton. To respond favorably to a petition for nonregulated status, APHIS 

must determine that COT67B cotton is unlikely to pose a plant pest risk. Based on its Plant Pest 

Risk Assessment (USDA-APHIS 2009) APHIS has concluded that COT67B cotton is unlikely 

to pose a plant pest risk. Therefore, APHIS must determine that COT67B cotton is no longer 

subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two 

alternatives were evaluated in the EA: (1) no action and (2) determination of non regulated 

status ofCOT67B cotton. APHIS has assessed the potential for environmental impacts for each 

alternative in the "Potential Environmental Consequences" section ofthe EA. 

No Action: Continuation as a Regulated Article 

Under the No Action Alternative, APHIS would deny the petition. COT67B cotton and progeny 

derived from COT67B cotton would continue to be regulated articles under the regulations at 7 

CFR part 340. Permits issued or notifications acknowledged by APHIS would still be required 

for introductions ofCOT67B 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 ofCOT67B cotton. 

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

PestRisk Assessment (USDA-APHIS 2009) that COT67B cotton is unlikely to pose a plant pest 

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

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

Preferred Alternative: Determination that COT67B cotton is No Longer a Regulated 

Article 

Under this alternative, COT67B cotton and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. COT67B cotton is unlikely to pose a 

plant pest risk (USDA-APHIS 2009). Permits issued or notifications acknowledged by APHIS 

would no longer be required for introductions ofCOT67B 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 COT67B cotton is unlikely to pose a plant pest risk, a determination of 

nonregulated status ofCOT67B 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 COT67B cotton and progeny derived from this event if the developer decides to 

commercialize Syngenta COT67B cotton. 

6 

Alternatives Considered but Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for COT67B cotton. The agency 

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

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

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

COT67B 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 COT67B from being released 

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

marketplace, APHIS considered prohibiting the release of COT67B cotton, including denying 

any permits associated with the field testing. APHIS determined that this alternative is not 

appropriate given that APHIS has concluded that COT67B cotton is unlikely to pose a plant pest 

risk (USDA-APHIS 2009). 

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 White House Emerging Technologies Interagency Policy Coordination Committee developed 

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

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

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

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

the extent permitted by law, when regulating emerging technologies: 

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

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

of each agency" 

Based on our Plant Pest Risk Assessment (USDA-APHIS 2009) and the scientific data 

evaluated therein, APHIS has concluded that COT67B cotton is unlikely to pose a plant pest 

risk. Accordingly, there is no basis in science for prohibiting the release ofCOT67B 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 COT67B 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 ofthe petition only in part. 

Isolation distance between COT67B cotton and non-GE cotton and geographical 

restrictions 

7 

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

considered requiring an isolation distance separating COT67B cotton from non-GE cotton 

production. However, because APHIS has concluded that COT67B cotton is unlikely to pose 

a plant pest risk (USDA-APHIS 2009), 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 ofCOT67B cotton based on the 

location ofproduction 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 COT67B cotton, there are no geographic 

differences associated with any identifiable plant pest risks for COT67B cotton (USDA-APHIS 

2009). This alternative was rejected and not analyzed in detail because APHIS has concluded 

that COT67B 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 of the Plant Protection Act. Nevertheless, APHIS is not expecting significant 

effects. However, individuals might choose on their own to geographically isolate their nonGE cotton productions systems from COT67B cotton or to use isolation distances and other 

management practices to minimize gene movement between cotton fields. 

Requirement ofTesting For COT67B 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 ofGE material in non-GE systems. Such a requirement would be extremely 

difficult to implement and maintain. Additionally, because COT67B cotton does not pose a 

plant pest risk (USDA-APHIS 2009), the imposition of any type oftesting requirements is 

inconsistent with the plant pest 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 COT67B 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 of the issues fully analyzed 

in the Environmental Consequences section of the EA. 

8 

Meets Purpose and 

Need and Objectives 

No 

Unlikely to pose a plant 

pest risk 

Satisfied through use 

ofregulated field trials 

Mana ement Practices 

I 

Acreage and Areas ofCotton . Production Unchanged 

Cropping practices Unchanged 

i Pesticide use Unchanged 

Seed Cotton Production Unchanged 

Organic Farming Unchanged 

Impact to Specialty Cotton Unchanged 

Environment 

Water use 

Soil 

. Gene Movement 

i Human and Animal Health 

Risk to Human Health 

I Risk to Worker Safety 

i Risk to Animal Feed 

Socioeconomic 

Domestic Economic 

Environment 

Trade Economic 

Environment 

Social Environment 

Unchanged 

Unchan ed 

Unchan ed 

Unchanged 

Unchan ed 

Unchan ed 

Unchan ed 

Unchan ed 

Unchanged 

Unchanged 

Unchanged 

nchanged 

nchanged 

nchanged 

Yes 

Satisfied - risk assessment 

(USDA-APHIS 2009) 

Unchanged 

Unchanged 

Minimal 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchan ed 

Unchanged 

Unchan ed 

Unchan ed 

Unchan ed 

Unchan ed 

Unchanged 

Minimal 

Unchanged 

nchanged 

nchanged 

nchanged 

9 

Other Regulatory 

Approvals 

u.s. FDA completed FDA completed 

consultations, EPA consultations, EPA tolerance 

tolerance exemptions and exemptions and conditional 

conditional pesticide pesticide registrations 

registrations granted granted 

Compliancewith 

Other Laws 

Finding of No Significant Impact 

The 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 not be prepared. This NEP A 

determination is based on the following context and intensity factors (40 CFR 1508.27): 

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

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

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 total 

cotton acres planted in 2009,88% were GE cotton and 65% ofthat GE cotton acreage was GE 

insect-resistant (Bt) cotton (USDA-ERS 2010). A determination ofnonregulated status of 

COT67B 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 

COT67B cotton will not change cultivation areas for cotton production in the U.S. and there are 

no anticipated changes to the availability of GE and non-GE cotton varieties on the market. 

Although a determination ofnonre gulated status ofCOT67B cotton would allow for new 

plantings ofCOT67B 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 ofCOT67B 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 ofthe 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 of nonregulated status ofCOT67B will have no significant 

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

10 
specialty cotton varieties. As discussed in Chapter 4 ofthe EA, a determination of 

nonregulated status ofCOT67B 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 COT67B cotton will not change cultivation areas 

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

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

status of COT67B 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 total cotton acres planted in 2009,88% were GE 

cotton and 65% ofthat GE cotton acreage was GE insect-resistant (Bt) cotton (USDAERS 2010). Based upon recent trend information, adding GE varieties to the market is 

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

Between 2000 and 2008, although 12 GE cotton events or lines were no longer 

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

the acreage associated with the organic production of cotton remained at slightly above 

15,000 acres (USDA-ERS 2009). A determination ofnonregulated status ofCOT67B 

cotton will not result in changes in the current practices of crop rotation, tillage, and 

overall pesticide use. As discussed in Chapter 4 ofthe EA, cotton production practices 

are expected to be unchanged, except for the availability of an additional Bt cotton 

variety to those that are currently available to fanners. A determination of nonregulated 

status ofCOT67B cotton is not expected to increase the total acreage of cotton 

production or the use ofBt cotton. Syngenta anticipates that COT67B cotton will 

primarily replace some ofthe Bt cotton cultivars already on the market today (Syngenta 

2007). However, if a grower replaces a non-Bt cotton variety with COT67B cotton then 

it would be expected that there would be a reduction in the use ofbudwormfbollworm 

insecticides. This has been the case with the adoption of other Bt cotton cultivars 

(Benbrook 2009). Studies demonstrate COT67B cotton is essentially indistinguishable 

from other cotton varieties used in terms of agronomic characteristics and cultivation 

practices (Syngenta 2007). COT67B cotton would not alter the agronomic practices, 

locations, and seed production and quality characteristics of conventional and GE seed 

production, nor pose a plant pest risk (USDA-APHIS 2009). 

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

A determination of nonregulated status of COT67B cotton would have no significant 

impacts on human or animal health. The food/feed nutritional and safety assessment for 

COT67B cotton has been reviewed by the FDA. Under the FFDCA, it is the 

responsibility offood and feed manufacturers to ensure that the products they market are 

safe and properly labeled. Food and feed derived from COT67B cotton must be in 

compliance with all applicable legal and regulatory requirements. FDA completed their 

consultation on COT67B cotton on February 13,2009 and concluded that it had "no 

further questions concerning food and feed derived from cotton event COT67B" (USFDA BNF No. 0112). The FDA considers Syngenta's consultation on COT67B cotton 

and its expression ofFLCrylAb to be complete (see Appendix A of the EA). The 

CrylAb protein is also present in a number ofB. thuringiensis cotton plant incorporated 

protectants registered by the US-EPA since 1996 and re-registered in 2001 and 2006. 

The FDA completed food and feed safety consultations for these products and the EPA, 

11 
through its statutory authority under the Federal Food Drug and Cosmetic Act, 

established a permanent exemption from the requirement of a tolerance for the 

FLCry1Ab protein and the genetic material necessary for its production in all plants (40 

CFR 180.1173). The health and safety of children and minorities were also considered in 

the establishment of this exemption from the requirement ofa tolerance. Based on the 

analysis offield and laboratory data and scientific literature provided by Syngenta 

(Syngenta 2007), and safety data available on earlier insect-resistant GE cotton, along 

with the completion ofthe consultation process with FDA, APHIS has concluded that a 

determination ofnonregulated status of COT67B cotton would have no significant 

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 ofgeographic areas such as park lands, prime farm 

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

adversely impacted by a determination ofnonregulated status ofCOT67B 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 ofownership of any property. This action is 

limited to a determination ofnonregulated status ofCOT67B cotton. The product will be 

deployed on agricultural land currently suitable for production of cotton, will replace 

existing varieties, and is not expected to increase the acreage of cotton production. 

Progeny ofthis variety that express the identified traits ofthe COT67B cotton will be 

retained by Syngenta or licensed users. This action would not convert land use to 

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

Standard agricultural practices for land preparation, planting, irrigation, and harvesting of 

plants would be used on agricultural lands planted to COT67B 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 ofnonregulated status ofCOT67B 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 ofCOT67B cotton are not highly controversial. Although there is 

some opposition to a determination of nonregu1ated status ofCOT67B 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 of COT67B 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 COT67B cotton will not change cultivation areas for 

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

GE and non-GE cotton varieties on the market. COT67B cotton is not expected to 

12 

increase the total acreage of cotton production or the use of Bt cotton. Syngenta 

anticipates that COT67B cotton will primarily replace some ofthe Bt cotton cultivars 

already on the market today (Syngenta 2007). A determination of nonregulated status of 

COT67B cotton will not result in changes in the current practices ofcrop rotation, tillage, 

and overall pesticide use. Studies demonstrate COT67B cotton is essentially 

indistinguishable from other cotton varieties used in terms of agronomic characteristics 

and cultivation practices (Syngenta 2007). The effect of COT67B cotton on wildlife or 

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

conventional agriculture in the U.S. During the public comment period, APHIS received 

comments opposing a determination ofnonregulated status of COT67B cotton. No new 

issues, alternatives or substantive new information were identified in any ofthe 

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

disagreement with APHIS' analyses of COT67B cotton detailed in the EA or the PPRA 

(USDA-APHIS 2009); 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, people who expressed their opposition to a determination ofnonregulated status 

did not provide any supporting evidence for their claims. APHIS has addressed 

substantive comments in the response to public comments document attached to this 

FONSI based on scientific evidence found in peer-reviewed, scholarly, and scientific 

journals. 

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 determination of nonregulated 

status ofCOT67B 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. Syngenta anticipates that COT67B cotton will primarily replace some of 

the Bt cotton cultivars already on the market today (Syngenta 2007). A determination 

ofnonregulated status ofCOT67B cotton will not result in changes in the current 

practices ofcrop rotation, tillage, and overall pesticide use. Studies demonstrate 

COT67B cotton is essentially indistinguishable from other cotton varieties used in terms 

ofagronomic characteristics and cultivation practices (Syngenta 2007). The effect of 

COT67B cotton on wildlife or biodiversity is no different than that ofother GE or nonGE 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), 

COT67B 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 of 

the cotton acreage in the U.S. is planted to GE cotton. Of the total cotton acres planted in 

2009,88% were GE cotton and 65% of that GE cotton acreage was GE insect-resistant 

13 

(Bt) cotton (USDA-ERS 2010). Based upon historic trends, conventional production 

practices that use GE varieties wi11likely continue to dominate in terms of acreage with 

or without a determination ofnonregulated status of COT67B cotton. 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 of COT67B 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 ofnonregulated status will be based upon an independent 

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

regulatory requirements of7 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 

of the Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the 

safe development and use of GE 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 COT67B cotton. When a petition for 

nonregulated status is submitted, APHIS must make a determination if the 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 no longer subject to the plant pest provisions 

ofthe 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 ifthe 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 ofthe 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. 

14 
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 

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

In the event of a determination of nonregulated status, COT67B 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 herbicides, but may also 

have progeny with no trans genes at all. There is no guarantee that COT67B cotton will 

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

the plant pest provisions ofthe Plant Protection Act and 7 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. 

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

or objects listed in or eligible for listing in the National Register ofHistoric Places or 

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

A determination of nonregulated status ofCOT67B cotton will not 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 COT67B 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 COT67B cotton. Standard agricultural practices for land 

preparation, planting, irrigation, and harvesting ofplants would be used on these 

agricultural lands including the use ofEPA registered pesticides. Applicant's adherence 

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

environment. A determination ofnonregulated status ofCOT67B 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 ofa 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 ofthe methods involved would only have temporary effects on the 

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

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

cultivation practices are already being conducted throughout the cotton production 

regions. The cultivation of COT67B cotton does not inherently change any ofthese 

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

15 
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 ofthe EA, APHIS has analyzed the potential for effects from 

cultivation of COT67B cotton and its progeny 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 ofCOT67B 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 COT67B cotton is unlikely to pose a plant pest 

risk, a determination of nonregulated status ofCOT67B cotton is a response that is 

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

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

Syngenta submitted a summary of its safety and nutritional assessment to FDA for 

COT67B cotton. In February 2009, FDA completed Syngenta's consultation on COT67B 

cotton regarding the safety and nutritional assessment for the cotton and had no further 

questions (US-FDA No.000112)(see Appendix A ofthe EA). Tolerance exemptions and 

conditional pesticide registrations have been granted for the plant-incorporated protectant 

in COT67B cotton and the genetic material necessary for its production. On July 16, 

2008, the EPA granted an exemption from the requirement of a tolerance for residues of 

FLCrylAb in or on food and feed commodities of cotton (73 FR 40760-40764). 

Likewise, on October 29,2008, EPA approved the conditional registration ofFLCrylAb 

produced in COT67B cotton for use as a lepidopteran insecticide (73 FR 64323-64324) 

(US-EPA 2008). There are no other Federal, state, or local permits that are needed prior 

to the implementation of this 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 COT67B cotton is No Longer a Regulated Article). 

This alternative meets APHIS' purpose and need to allow the safe development and use of 

genetically 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, 

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

16 

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 COT67B cotton, the continued 

regulated status ofCOT67B cotton would be inconsistent with the plant pest provisions of the 

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

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

nonregulated status ofCOT67B 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 ofAgriculture 

Literature Cited: 

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

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

Syngenta (2007). Petition for the Determination ofNonregulated Status for Event COT67B. 

Submitted by J. N. Reed, Regulatory Affairs Manager. Syngenta Biotechnology, Inc. (See Table 

http://www .aphis. usda.gov/biotechnologylnot reg.html). 

US-EPA (2008). Biopesticides Registration Action Document Bacillus thuringiensis modified 

CrylAb (SYN-IR67B-l) and Vip3Aa19 (SYN-IRI02-7) insecticidal proteins and the genetic 

material necessary for their production in COT102 XCOT67B cotton. 

USDA-APHIS (2009). Plant pest risk assessment for Syngenta COT67B cotton. Riverdale, MD, 

USDA APHIS Biotechnology Regulatory Services. 

USDA-ERS (2009). "Data Sets: Organic Production." Retrieved January 20,2010, from 

http://www.ers.usda.gov/datalorganic/#national. 

USDA-ERS (2010). "Adoption ofGenetically Engineered Crops in the U.S.". Retrieved April 

29,2010, from http://\.vww.ers.usda.govlData/BiotechCrops/. 

USDA-NASS (2010). "The Census ofAgriculture." Retrieved January 11, 2010, from 

http://www.agcensus.usda.gov/. 

17 
Attachment 

Finding of No Significant Impact 

Response to Comments 

Petition 07-I08-0Ip 

On May 11,2011, APHIS published a notice in the Federal Register (76 FR 27301-27303, 

Docket no. APHIS-2007-0 130) announcing the availability ofthe Syngenta 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 July 11, 2011. All comments were carefully analyzed to 

identify new issues, alternatives, or information. A total of7 comment responses were received 

from various groups and individuals during the comment period. An additional 4,045 names 

were submitted as an attachment to one ofthe comment documents. No new issues, alternatives 

or substantive new information were identified in any ofthe comments received by APHIS. The 

7 comments expressed opposition to a determination of nonregulated status ofCOT67B 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 ofCOT67B cotton detailed in the EA 

or the PPRA; 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, people who expressed their 

opposition to a determination ofnonregulated status did not provide any supporting evidence for 

their claims. In addition, a single public comment generally claimed that the draft EA was 

inadequate. However, no explanation was provided for this reasoning. The following are 

responses to substantive comments received by APHIS. 

I. 	Comment: A commenter expressed concern regarding gene flow from COT67B cotton to 

organic cotton. 

Response: As discussed in Chapter IV ofthe EA, it is not likely that organic farmers, or other 

farmers who choose not to plant transgenic varieties or sell transgenic seed, will be substantially 

impacted by the expected commercial use ofCOT67B cotton. Transgenic cotton lines including 

those that are resistant to lepidopteran insects are already in widespread use by farmers. 

COT67B cotton should not present any new and different issues and impacts for organic and 

other specialty cotton producers and consumers. According to the petition, agronomic trials 

conducted in 2005 and 2006 in a variety of locations in the U.S. demonstrated that COT67B 

cotton is not significantly different in plant growth, yield, and reproductive capacity from its 

nontransgenic counterpart (Syngenta, 2007). No differences were observed in pollen diameter, 

weight, and viability. Therefore, COT67B cotton is not expected to have an increased ability to 

cross pollinate other cotton varieties. 

Organic farming operations as described by the USDA National Organic Program (NOP) 

requires organic production operations to have distinct, defined boundaries and buffer zones to 

prevent unintended contact with excluded methods from adjoining land that is not under organic 

management. Practices organic growers may use to exclude GE products include planting only 

organic seed, planting earlier or later than neighboring farmers who may be using GE crops so 

that the crops will flower at different times, and employing adequate isolation distances 

between the organic fields and the fields of neighbors to minimize the chance that pollen will 

18 

be carried between the fields (Baier, 2008; Bradford, 2006; NCAT, 2003; Sundstrom et aI., 

2002). Commonly used production practices for cotton and the practical methods typically used 

by cotton farmers using organic methods to protect their crop under organic production (NCAT, 

2003) provide many measures that greatly reduce the likelihood of accidental gene flow 

between COT67B cotton and non-GE cotton fields. 

The US-EPA (2001) acknowledges the potential for gene transfer ofthe Bt endotoxin from Bt 

cotton to other cultivated cotton varieties in close proximity. However, commercially available 

cotton cultivars are generally considered to be self-pollinated (Hartman et aI., 1981). Wind 

pollination is considered unimportant because cotton pollen is heavy and sticky and is not 

transported easily by the wind. Some insect cross-pollination can occur if suitable insects are 

present and in large enough numbers (Fryxell, 1979; McGregor, 1976). However, pollen 

movement by insects is considered to be low (McGregor 1976). A majority of field-based 

research with cotton shows an outcrossing rate of 10% or less within 1 meter ofthe pollen 

source (Andersson and Carmen de Vicente, 2010). Cross pollination percentages between 

cotton plots remain very low and exponentially decrease with distance, regardless ofpotential 

insect pollinator activity (Llewellyn and Fitt, 1996; Van Deynze et aI., 2005). These results 

demonstrated and reinforced the efficacy of separation distance as a tool in mitigating gene flow 

between neighboring cotton fields (Umbec et aI., 1991; USDA-APHIS, 2011), where cross 

pollination was found to average 0.01 percent at a distance of 5331 feet (Van Deynze et aI., 

2005). 

Based on these factors and organic cotton growers continued adherence to NOP approved 

production standards, such as the maintenance of adequate isolation distances between GE and 

non-GE cotton fields, the planting ofborder or barrier rows to intercept pollen, employing 

natural barriers to pollen movement such as tree lines, and staggering planting dates, a 

determination of nonregulated status ofCOT67B cotton would not increase the likelihood of 

gene flow from COT67B cotton to organic cotton. 

References 

Andersson, M. S. and M. Carmen de Vicente (2010). Gene Flow between Crops and Their Wild 

Relatives. Baltimore, The Johns Hopkins University Press. 

Hartman, H. T., W. J. Plocker, et a1. (1981). Plant Science: Growth, Development and Utilization 

ofCultivated Plants. Englewood Cliffs, NJ, Prentice-Hall, Inc. 

Andersson MS and Carmen de Vicente M. (2010) Gene Flow between Crops and Their Wild 

Relatives. Baltimore: The Johns Hopkins University Press. 

Baier A (2008). Organic standards for crop production A TTRA. Retrieved December, 2010 

from http://attra.ncat.org!attra-pub/PDF/nopstandard crops.pdf 

Bradford KJ (2006). Methods to Maintain Genetic Purity of Seed Stock Publication 8189. 

University ofCalifornia, Division ofAgriculture and Natural Resources. Retrieved from 

http://ucanr.org!freepubs/docs/8189.pdf 

Fryxell PA. (1979) The Natural History ofthe Cotton Tribe (Malvaceae, tribe Gossypieae). 

College Station and London: Texas A&M University Press 

Hartman HT, Plocker WJ, and Kofranck AM. (1981) Plant Science: Growth, Development and 

Utilization ofCultivated Plants. Englewood Cliffs, NJ: Prentice-Hall, Inc. 

19 
Llewellyn D and Fitt G. (1996) Pollen dispersal from two field trials oftransgenic cotton in the 

Namoi Valley, Australia. Molecular Breeding, 2(2), 157-166. 

McGregor SE. (1976) Insect Pollination o/Cultivated Crop Plants. Washington: U.S. 

Government Printing Office. 

NCAT (2003). NCAT's organic crops workbook: a guide to sustainable and allowed practices 

National Center for Appropriate Technology. Retrieved March 30, 2010 from 

http://attra.ncat.org/attra-pub/PDF/cropsworkbook.pdf 

Sundstrom F, Williams J, Van Deynze A, and Bradford K (2002). Identity Preservation of 

Agricultural Commodities Seed Biotechnology Center, UC Davis. Retrieved June, 2011 

from http://ucanr.orglfreepubs/docs/B077 .pdf 

Syngenta (2007). Petition for the Determination ofNonregulated Status for Event COT67B. 

Submitted by J. N. Reed, Regulatory Affairs Manager. Syngenta Biotechnology, Inc. 

(See Table http://\\'Ww.aphis.usda.gov/biotechnologyinot reg.htm}). 

Umbec P, Barton K, Nordheim E, McCarty J, Parrott W, and Jenkins J. (1991) Degree of Pollen 

Dispersal by Insects from a Field Test of Genetically Engineered Cotton. Journal 0/ 

Economic Entomology, 84, 1943-1950. 

USDA-APHIS (2011). Syngenta Biotechnology, Inc. Petition (07-lOB-Olp) for Determination of 

Nonregulated Status of Lepidopteran-Resistant Event COT67B Cotton Draft 

Environmental Assessment United States Department ofAgriculture - Animal and Plant 

Health Inspection Service. Retrieved June, 2011 from 

http://ww\v.aphis.usda.gov/brs/aphisdocs/07 10801p dea.pdf 

Van Deynze AE, Sundstrom FJ, and Bradford KJ. (2005) Pollen-Mediated Gene Flow in 

California Cotton Depends on Pollinator Activity. Crop Sci., 45(4), 1565-1570. 

2. 	 Comment: A commenter expressed concern regarding the safety ofCOT67B fiber on human 

skin. 

Response: As discussed in Chapter IV ofthe EA, based on the analysis offield and laboratory 

data and scientific literature provided by Syngenta (Syngenta, 2007), and safety data available on 

earlier insect-resistant GE cotton, along with the completion ofthe consultation process with 

FDA, APHIS has concluded that a determination ofnonregulated status ofCOT67B cotton 

would have no significant impacts on human health. 

The EPA concluded that human exposure to Cry proteins as the result of skin contact with plants 

is not likely, due to the containment ofCry proteins within individual plant cells that limits this 

exposure route (EPA, 2010). Following a voluntary consultation between Syngenta 

Biotechnology and the FDA regarding COT67B, FDA concluded that COT67B does not present 

a human health risk (FDA, 2011). Additionally, the CrylAb protein, like several other similar 

Cry proteins, was granted a permanent exemption from the requirement of tolerance by the EPA 

through its statutory authority under the Federal Food Drug and Cosmetics Act (40 CFR 

IBO.1173). 

Dermal contact with CrylAb in processed COT67B fiber is unlikely to pose a human health risk 

due to several factors. These factors include: a) a lack of similarity between CrylAb and any 

known toxin (beyond other Cry proteins) or allergen following a bioinformatics query; b) the 

recognition by FDA and EPA that CrylAb is unlikely to pose a significant human health risk; c) 

20 

the absence of CrylAb in COT67B fiber separated from seed; and d) the fact that the processing 

of cotton fiber prior to incorporation into various products results in little or no plant protein 

persistence of any kind (Davies et aI., 2001; ICAC, 2000; Syngenta, 2007). Thus, direct dermal 

exposure to COT67B fiber is unlikely to result in a human health risk because CrylAb is not 

regarded as a risk to human health and it is unlikely to be found in processed cotton fibers used 

in clothing. 

References 

Davies H, Williams D, and Hardy A (2001) Opinion on Genetically Modified Cotton and 

Medical Devices. European Commission Health and Consumer Protection DirectorateGeneral. Retrieved June, 2011 from http://ec.europa.eu/foodJfs/sc/ssc/out216 en.pdf 

EPA (2010) Biopesticide Registration Action Document: CrylAb and CrylF Bacillus 

thuringiensis (Bt) Corn Plant-Incorporated Protectants. Washington DC: Environmental 

Protection Agency. Retrieved June, 2011 from 

http://www.epa.gov/oppbppdllbiopesticides/pips/cryl f-crylab-brad.pdf 

FDA (2011). Completed Consultation on Bioengineered Foods Food and Drug Administration. 

Retrieved June, 2011 from 

http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfin.?rpt=bioListing 

ICAC (2000) Report of an Expert Opinion on Biotechnology in Cotton. Washington DC: 

International Cotton Advisory Committee. Retrieved June, 2011 from 

http://www.icac.org/cotton info/tislbiotech/ documents/expert panel/Reportexpert. pdf 

Syngenta (2007). Petition for the Determination ofNonregulated Status for Event COT67B. 

Submitted by J. N. Reed, Regulatory Affairs Manager. Syngenta Biotechnology, Inc. 

(See Table http://w'WW.aphis.usda.govlbiotechnologyinot reg.htmn. 

21