### NATIONAL ENVIRONMENTALPOLICY ACT DECISION AND 

### FINDING OFNO SIGNIFICANT IMPACT

SYNGENTA BIOTECHNOLOGY,INC. LEPIDOPTERAN-RESISTANT EVENT COT67B COTTON

United States DepartmentofAgriculture Animal and PlantHealth Inspection Service Biotechnology Regulatory Services

The United States Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has developed this decision document to complywith the requirements ofthe National Environmental Policy Act (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing regulations and procedures. This NEPA decision document, a Finding ofNo Significant Impact (FONS!), sets forth APHIS' NEPA decision and its rationale. Comments from thepublic involvement process were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementingNEPA (7 CFRpart 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated status ofa petitionrequest (APHIS Number 07-108-01p) by Syngenta Biotechnology, Inc. (Syngenta) for their geneticallyengineered Event COT67B cotton (COT67B (OECD Unique Identifier SYN-IR67B-I» that expresses a CrylAbprotein to protect cotton plants from lepidopteran insect damage. This EAhas been prepared in orderto specifically evaluate the effects on the quality ofthe human environment! that may result from a determination of

. nonregulated status ofCOT67B cotton. The EA assesses alternatives to a determination of nonregulated status ofCOT67B cotton and analyzes the potential environmental and social effects thatresult from theproposed action and the alternatives. 

### Regulatory Authority "Protecting American agriculture" is the basic charge ofAPHIS. APHIS provides leadership in ensuring the health and care ofplants and animals. The agency improves agricultural productivity and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural production (conventional, organic, orthe use of 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 FR23302,57 FR22984). The Coordinated Framework, publishedbythe Office ofScience and Technology Policy, describes the

I Under NEPA regulations, the "human environment" includes "the natural and physical environment and the relationship ofpeople with that environment" (40 CFR §50S.14).
1comprehensive federal regulatory policy for ensuring the safety ofbiotechnologyresearch and products and explains how federal agencies will use existing Federal statutes in a manner to
ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth ofthebiotechnology 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 bytheirrespective statutory authorities; (2) agencies are required to focus on the characteristics and risks ofthe biotechnologyproduct, not the process by which it is created; (3) agencies are mandated to exercise oversight ofGE organisms only when there is evidence of"unreasonable"risk.

The Coordinated Framework explains the regulatoryroles and authorities for the three major agencies involved in regulating GE organisms: USDA's APHIS, the Food and Drug Administration (FDA), and the Environmental ProtectionAgency (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 

### etseq.) to ensure that they do not pose a plantpestrisk to the environment.

The FDAregulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and proper labeling ofall plant-derived foods and feeds, includingthose that are genetically engineered. To help developers offood and feed derived from GE crops complywith their obligations underFederal food safety laws, FDA encourages them to participate in a voluntary consultationprocess. All food and feed derived from GE crops currently on the marketin the United States have successfully completed this consultation process. TheFDApolicy statement concerning regulation ofproducts derived from
new plantvarieties, including those genetically engineered, was published in the Federal Register
on May 29, 1992 (57 FR 22984-23005). Underthis policy, FDAuses what is termed a consultation process to ensure that human food and animal feed safety issues orotherregulatory 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 underthe Toxic Substances Control Act (TSCA). The EPA is responsible for regUlating the sale, distribution and use of pesticides, includingpesticides that are produced by an organism through techniques ofmodern biotechnology. 

### Regulated Organisms The APHIS Biotechnology Regulatory Service's (BRS) mission is to protectAmerica's agriculture and environment using a dynamic and science-based regulatory framework that allows for the safe development and use ofGE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were 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, orrelease into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plantpestprovisions ofthe Plant Protection Act orto the regulatoryrequirements of7 CFRpart 340 when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated

2article ifthe donor organism, recipient organism, vector, orvector 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 maybe a plant pest or APHIS does nothave information to determine if the GE organism is unlikelyto pose a plantpest risk.

A person maypetition the agency that a particular regulated article is unlikelyto pose a plant pestrisk, and, therefore, is no longer regulated under the plant pestprovisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. The petitioner is required to provide information under 

### § 340.6(c)(4) related to plant pestrisk that the agency mayuse to determine whetherthe regulated article is unlikelyto present a greaterplantpest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plantpest risk.

APHIS' Response to Petition for Nonregulated Status Under the authority oftheplant pestprovisions ofthe Plant Protection Act and 7 CFRPart 340, APHIS has issued regulations for the safe development and use ofGE organisms. As required by7 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 ifthe GE organism is unlikely to pose a plantpest risk. IfAPHIS determines based on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organism is unlikely to pose a plant pestrisk, the genetically engineered organism is no longer subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340.
Syngenta Biotechnology, Inc. (Syngenta) has submitted a petition (APHIS Number07-108-01p) to APHIS seeking a determination that their genetically engineered Event COT67B cotton is unlikelyto pose a plantpest risk and, therefore, should no longer be a regulated article under regulations at 7 CFRPart 340.
Syngenta Lepidopteran-ResistantEvent 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 cottonproduces a full-length CrylAbprotein originally derived from Bacillus thuringiensis subsp. leurstald HD-l which has activity against several important lepidopteranpest species ofcotton. 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, eitheralone orwhen combinedby traditional breeding with other genetically-modified insectresistant cotton varieties, will provide growers with an additional pest management option for lepidopteraninsectpestcontrol and will contribute to a reduction in the likelihood ofinsectresistance to Bt insect-resistant cotton varieties.

Coordinated FrameworkReview



### 3COT67B cotton is designed for human and animal consumption and as such, may also be subject to regulation bythe FDA. FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues or otherregulatory issues (e.g., labeling) are resolved priorto commercial distribution ofbiotechnology-derived food. Syngenta submitted a summary ofits 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 otherrelevant 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 havebeen 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 ofa tolerance for residues ofFLCrylAb in oron food and feed commodities ofcotton (73 FR40760-40764). Likewise, onOctober 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 oftheEnvironmental Analysis Althougha determination ofnonregulated status ofCOT67B cotton would allow for new plantings ofCOT67B cotton to occur anywhere inthe U.S., APHIS primarily focused the environmental analysis to those geographic areas that currently support cottonproduction. A determination ofnonregulated status ofCOT67B cotton is not expected to increase cotton production, eitherby its availability alone oraccompanied byother factors, orcause an increase in overall GE cotton acreage. To determine areas ofcotton production, APHIS used data from the National Agricultural Statistics Service (NASS) 2007 Census ofAgriculture to determine where cotton is produced in the U.S. (USDA-NASS 2010). Cottonwas produced in 17 states includingAlabama, 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 FR27301-27303, Docketno. APHIS-2007-0130) announcing the availability ofthe Syngenta petition, and the APHIS PPRA and draft EA for a 60-daypublic review and comment period. Comments were required to be received on orbefore July 11, 2011. All comments were carefully analyzed to identifynew issues, alternatives, orinformation. A total of7 comment responses were received from various groups and individuals during the commentperiod. 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 receivedbyAPHIS. The 7 comments expressed opposition to a determination ofnonregulated status ofCOT67B cotton, but did not change the analysis provided in the PPRA ordraft EA. These individuals did not mention their specific disagreement with APHIS' analyses ofCOT67B cotton detailed in the EA

4orthe PPRA (USDA-APHIS 2009); rather, they expressed their general opposition to genetically modified organisms (GMOs) orGE 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. 

### MajorIssues Addressed in 

### theEA The issues considered in the EA were developed based on APHIS' determination to that certain genetically engineered organisms are no longer subject to the plantpest provisions ofthe Plant Protection Act and 7 CFRpart 340, and for this particular EA, the specific petition seeking a determination ofnonregulated status ofCOT67B cotton. Issues discussed in the EA were developed byconsidering public concerns as well as issues raised in public comments submitted for other environmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well as those issues thathave 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 evaluatedusingthe identified issues. The following issues were identified as important to the scope ofthe analysis (40 CFR 1508.25):
Management Considerations

• Acreage and Areas ofCotton Production

• Cropping Practices
.• Seed Production

• Organic Farming
• Specialty Cotton Production

Environmental Considerations

• WaterUse

• Soil 

# • Air Quality Climate Change 

# • • Animals Plants 

# • 

# • Biological Diversity 

# • Gene Movement

Public Health Considerations

• Human Health
• Worker Safety
• Animal Feed

5Socioeconomic Considerations

• Domestic Economic Environment

• Trade Economic Environment

• Social Environment



### Alternatives that were fully analyzed The EA analyzes the potential environmental consequences ofa determination ofnonregulated status ofCOT67B 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 CFRpart 340 or the plantpestprovisions ofthe Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination ofnon 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 denythe petition. COT67B cotton and progeny derived from COT67B cotton would continue to be regulated articles under the regulations at 7 CFRpart 340. Permits issued ornotifications acknowledged byAPHIS would still berequired 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 demonstratethe lack ofplantpestrisk from the unconfined cultivation ofCOT67B cotton.

This alternative is notthe Preferred Alternative because APHIS has concludedthrough a Plant PestRisk Assessment (USDA-APHIS 2009) that COT67B cotton is unlikely to pose a plantpest risk. Choosing this alternative would not satisfy the purpose andneed ofmaking a determination ofplantpestrisk status andresponding to the petition for nonregulated status.



### PreferredAlternative: Determination that COT67B cotton is No Longer a Regulated Article Under this alternative, COT67B cotton and progeny derived from them would no longerbe regulated articles underthe regulations at 7 CFRpart 340. COT67B cotton is unlikely to pose a plant pestrisk (USDA-APHIS 2009). Permits issued ornotifications acknowledged byAPHIS would no longerberequired 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 plantpest provisions ofthe PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. Under this alternative, growers mayhave future access to COT67B cotton and progeny derived from this event ifthe developer decides to commercialize Syngenta COT67B cotton.

6Alternatives Considered but Rejected from Further Consideration APHIS assembled a list ofalternatives that might be considered for COT67B cotton. The agency evaluated these alternatives, in light ofthe agency's authority under the plant pestprovisions of the Plant ProtectionAct, and the regulations at 7 CFRpart 340, with respect to environmental safety, efficacy, and practicality to identifywhich alternatives would be further considered for COT67B cotton. Based on this evaluation, APHIS rejected several alternatives. These alternatives are discussed brieflybelow along with the specific reasons for rejecting each.



### Prohibitany COT67B from being released In response to public comments that stated a preference that no GE organisms enterthe marketplace, APHIS considered prohibiting the release ofCOT67B cotton, including denying anypermits 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).

OnMarch 11,2011, in a Memorandum for the Heads ofExecutive Departments and Agencies, the White House Emerging Technologies Interagency PolicyCoordination Committee developed broad principles, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemerging technologies (such as genetic engineering) at the agency level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principle, among others, to the extentpermitted bylaw, when regulating emerging technologies:
"[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within theboundaries ofthe authorities and mandates ofeach agency"

Based on ourPlant Pest Risk Assessment (USDA-APHIS 2009) and the scientific data evaluated therein, APHIS has concluded that COT67B cottonis unlikely to pose a plant pest risk. Accordingly, there is no basis in science for prohibiting the release ofCOT67B cotton. 

### Approvethepetition inpart The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole
or in part." For example, a determination ofnonregulated status in part maybe appropriate if there is a plant pestrisk associated with some, but not all lines described in a petition. Because APHIS has concluded that COT67B cotton is unlikely to pose a plantpest risk, there is no regulatorybasis under the plant pest provisions ofthe Plant Protection Act for considering approval ofthe petition only in part.


### Isolation distance between COT67B cotton andnon-GE cotton andgeographical restrictions
7In response to public concerns ofgene 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 plantpest provisions ofthe 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 movementbetween 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 pestrisk, 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 plantpestprovisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnology regulatorypolicies embodied in the Coordinated Framework.

Based on the foregoing, the imposition ofisolation distances orgeographic restrictions would notmeetAPHIS' purpose and need to respond appropriately to a petition for nonregulated status based onthe 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 nonGE cotton productions systems from COT67B cotton orto use isolation distances and other management practices to minimize gene movementbetween cotton fields.


### Requirementof Testing For COT67B Cotton During the comment periods for otherpetitions for nonregulated status, some commenters requested USDA to require and providetesting to identify GE products in non-GE production systems. APHIS notes there are no nationally-established regulations involving testing, criteria, orlimits ofGE material in non-GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, because COT67B cotton does not pose a plantpestrisk (USDA-APHIS 2009), the imposition ofany type oftesting requirements is inconsistent with the plant pestprovisions ofthe Plant Protection Act, the regulations at7 CFR part 340 and the biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a requirement for COT67B cotton would not meetAPHIS' purpose and need to respond appropriatelyto the petition in accordance with its regulatory authorities.

Environmental Consequences ofAPHIS' Selected Action The EA contains a full analysis ofthe 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 ofthe EA.

8

### MeetsPurposeand Need and Objectives No
Unlikely to pose a plant pestrisk Satisfied through use ofregulated field trials



### Mana ementPractices

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 Wateruse Soil

. Gene Movement

i 

### Human andAnimalHealth

Riskto HumanHealth


### I Riskto Worker Safety

i Riskto 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

9OtherRegulatory 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 

### OtherLaws

Finding ofNo 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" recognizespotentially affected resources, as well as the location and setting in which the environmental impact would occur. This action has potential to affect conventional and organic cotton production systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commoditymarkets. Most ofthe cotton acreage in the U.S. is planted to GE cotton. Ofthe 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 expectedto 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 inthe U.S. and there are no anticipated changes to the availability ofGE and non-GE cotton varieties on the market.
Althougha determination ofnonregulated status ofCOT67B cotton would allowfor new plantings ofCOT67B cotton to occuranywhere inthe 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, eitherbyits availability alone or accompanied by other factors, orcause an increase in overall GE cotton acreage. Intensity Intensity is a measure ofthe degree or severity ofan impact based upon the ten factors. The following factors were used as a basis for this decision:

1. Impacts that may be both beneficial andadverse. A determination ofnonregulated status ofCOT67B will have no significant environmental impact in relation to the availability ofGE, conventional, organic or

10specialty cotton varieties. As discussed in Chapter4 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 ofCOT67B 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 ofnonregulated status ofCOT67B cotton could add another GEcotton variety to the conventional cotton market and is not expected to change the market demands for GE cotton orcotton 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 uponrecenttrend information, adding GE varieties tothe market is notrelated to the ability oforganic production systems to maintain their market share. Between 2000 and 2008, although 12 GE cotton events or lines were no longer subjectto the plant pest provisions ofthe Plant Protection Act and 7 CFR part 340, the acreage associated with the organic productionofcotton remained at slightly above 15,000acres (USDA-ERS 2009). A determination ofnonregulated status ofCOT67B cotton will not result in changes in the current practices ofcrop rotation, tillage, and overall pesticide use. As discussed in Chapter4 ofthe EA, cottonproductionpractices
are expected to be unchanged, except for the availability ofan additional Bt cotton variety to those that are currently available to fanners. A determination ofnonregulated status ofCOT67B cotton is not expected to increase the total acreage ofcotton production orthe use ofBt cotton. Syngenta anticipates that COT67B cotton will primarilyreplace some ofthe Btcotton cultivars already on the market today (Syngenta 2007). However, ifa growerreplaces a non-Bt cotton varietywith COT67B cotton then it would be expected that there would be a reduction in the use ofbudwormfbollworm insecticides. This has been the casewith the adoption ofother Bt cotton cultivars (Benbrook 2009). Studies demonstrate COT67B cotton is essentially indistinguishable from othercotton varieties used in terms ofagronomic characteristics and cultivation practices (Syngenta 2007). COT67B cotton would not alterthe agronomic practices, locations, and seed production and quality characteristics ofconventional and GE seed production, norpose a plantpest risk (USDA-APHIS 2009). 

### 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofCOT67B cottonwould have no significant impacts on human or animal health. The food/feed nutritional and safety assessment for COT67B cotton has been reviewed bythe FDA. Under the FFDCA, it is the responsibility offood and feed manufacturers to ensure that the products theymarket are safe and properlylabeled. Food and feed derived from COT67B cotton mustbe 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 BNFNo. 0112). The FDA considers Syngenta's consultation on COT67B cotton and its expression ofFLCrylAb to be complete (see Appendix A ofthe EA). The CrylAb protein is also present in a number of

### B. thuringiensis cotton plantincorporated protectants registered bythe US-EPA since 1996 and re-registered in 2001 and 2006. The FDA completed food and feed safetyconsultations for these products and the EPA,

11through its statutory authority under the Federal Food Drug and Cosmetic Act, established apermanent exemption from the requirement ofa tolerance for the FLCry1Ab protein and the genetic material necessary for its production in all plants (40 CFR 180.1173). The health and safety ofchildren and minorities were also considered in the establishment ofthis exemption from therequirement ofa tolerance. Based on the analysis offield and laboratory data and scientific literature providedby Syngenta (Syngenta 2007), and safety data available on earlier insect-resistant GE cotton, along with the completion ofthe consultationprocess withFDA, APHIS has concluded that a determination ofnonregulated status ofCOT67B cotton would have no significant impacts on human or animal health. 

### 3. Unique characteristics of the geographic area such asproximity to historic orcultural resources,parklands, prime farmlands, wetlands, wildandscenic rivers, or ecologically critical areas. There are no unique characteristics ofgeographic areas such aspark lands, prime farm lands, wetlands, wild and scenic areas, or ecologicallycritical areas that would be adverselyimpacted by a determination ofnonregulated status ofCOT67B cotton. The
common agricultural practices that would be carried outunderthe proposed action will not cause major ground disturbance; do not cause anyphysical destruction or damage to property; do not cause any alterations ofproperty, wildlife habitat, orlandscapes; and do not involve the sale, lease, or transfer ofownership ofanyproperty. This action is limited to a determination ofnonregulated status ofCOT67B cotton. The product will be deployed on agricultural land currently suitable for production ofcotton, will replace existing varieties, and is not expected to increase the acreage ofcotton production. Progeny ofthis varietythat express the identified traits ofthe COT67B cotton will be retained by Syngenta orlicensed users. This action would not convertland use to nonagricultural use and therefore would have no adverse impact onprime farm land. Standard agricultural practices for landpreparation, planting, irrigation, and harvesting of plants wouldbe 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 ofa determination ofnonregulated status ofCOT67B cotton, the action is not likely to affect historic orcultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologicallycritical areas that maybe in close proximityto cotton production sites. 

### 4. The degree to which the effects on the quality of the human environment are likely to be highly controversial. The effects on the quality ofthe human environment from a determination of nonregulated status ofCOT67B cotton are not highly controversial. Although there is
some opposition to a determination ofnonregu1ated status ofCOT67B cotton, this action is not highly controversial in terms ofsize, nature or effect on the natural orphysical environment. As discussed in Chapter 4 ofthe EA, a determination ofnonregulated 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 ofCOT67B 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

12increase the total acreage ofcotton production orthe use ofBt cotton. Syngenta anticipates that COT67B cotton will primarilyreplace some ofthe Bt cotton cultivars already on the market today (Syngenta 2007). A determination ofnonregulated status of COT67B cotton will not result in changes in the currentpractices ofcrop rotation, tillage, and overall pesticide use. Studies demonstrate COT67B cotton is essentially indistinguishable from othercotton varieties used in terms ofagronomic characteristics and cultivation practices (Syngenta 2007). The effect ofCOT67B cotton on wildlife or biodiversity is no different than that ofother GE ornon-GE cotton produced in conventional agriculture in the U.S. During the public commentperiod, APHIS received comments opposing a determination ofnonregulated status ofCOT67B cotton. No new issues, alternatives or substantive new information were identified in any ofthe comments received by APHIS. These individuals did notmention their specific disagreement with APHIS' analyses ofCOT67B cotton detailed in the EA orthe 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 expressedtheir 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 thepossible effects on the human environment are highly uncertain
or involve unique or unknown risks. Based on the analysis documented in the EAthe possible effects on the human environment are well understood. The effects ofthe proposed activities arenothighly uncertain and do not involve unique orunknown risks on the natural orphysical environment. As discussed in Chapter 4 ofthe EA, a determination ofnonregulated status ofCOT67B cotton is not expectedto directly cause an increase in agricultural acreage devotedto cotton production, or those cotton acres devoted to GE cotton cultivation. Syngenta anticipates that COT67B cotton will primarily replace some of the Btcotton cultivars already on the markettoday (Syngenta 2007). A determination ofnonregulated status ofCOT67B cotton will notresult in changes in the current practices ofcrop rotation, tillage, and overall pesticide use. Studies demonstrate COT67B cotton is essentially indistinguishable from othercotton varieties used in terms ofagronomic characteristics and cultivation practices (Syngenta 2007). The effect of COT67B cotton on wildlife orbiodiversity is no different than that ofotherGE ornonGE cotton produced in conventional agriculture in the U.S. As described in Chapter 4 of the EA, well established managementpractices, production controls, andproduction practices (GE, conventional, and organic) are currentlybeing used in cotton production systems (commercial and seedproduction) in the U.S. Therefore, it is reasonable to
assume that farmers, who produce conventional cotton (GE and non-GE varieties), COT67B cotton, orproduce cotton using organic methods or specialty systems, will continue to use these reasonable, commonly acceptedbest managementpractices 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. Ofthe total cotton acres planted in 2009,88% were GE cotton and 65% ofthat 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 ofacreage with
orwithout a determination ofnonregulated status ofCOT67B cotton. Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use ofGE cotton products, the possible effects to thehuman environment from the release of
a an additional GE cottonproduct are already well known and understood. Therefore the impacts are not highly uncertain, and do not involve unique orunknown risks. 

### 6. The degree to which the action may establish aprecedent for future actions with significant effects orrepresents a decision inprinciple about a future consideration. A determination ofnonregulated status ofCOT67B 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 aplantpestrisk pursuant to the regulatory requirements of7 CFRpart 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes this independent review to determine ifthe regulated articleposes a plantpestrisk. Under the authority ofthe plant pestprovisions ofthe Plant Protection Act and 7 CFRPart 340, APHIS has issued regulations for the safe development and use ofGE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as COT67B cotton. When a petition for nonregulated status is submitted, APHIS must make a determination ifthe GE organism is unlikelyto pose a plantpest risk. IfAPHIS determines based on its Plant Pest Risk Assessment that the genetically engineered organism is unlikely to pose a plantpestrisk, the genetically engineered organism is no longer subject to the plant pestprovisions of the Plant Protection Act and 7 CFRpart 340. APHIS regulations at 7 CFRpart 340, which were promulgatedpursuant 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, orrelease into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plantpest provisions ofthe Plant Protection Act or to the regulatory requirements of7 CFRpart 340when APHIS determines that it is unlikely to pose a plant pestrisk. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, orvector 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 thatthe GE organism maybe a plantpest or APHIS does not have information to determine ifthe GE organism is unlikely to pose a plant pestrisk. A person maypetition the agency that a particular regulated article is unlikely to pose a plantpestrisk, and, therefore, is no longerregulated 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 pestrisk that the agency mayuse to determine whether the regulated article is unlikely to present a greaterplant pestrisk than the unmodified organism. A GE organism is no longer subject to the regulatoryrequirements of7 CFRpart 340 or the plant pest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plantpestrisk.

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### 7. Whether the action is related to otheractions 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 Chapter4 ofthe EA. In the event ofa determination ofnonregulated status, COT67B cotton may be stacked (combined) with non-GE and GE cotton varieties bytraditional breeding techniques, resulting in a plant that, for example, may also beresistantto herbicides, butmay also have progeny with no transgenes at all. There is no guarantee that COT67B cotton will be stacked with any particular non-GE orGE cotton varieties that are no longer subject to theplantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340, as company plans and market demands playa significant role in those business decisions. Thus, predicting all potential combinations ofstacked varieties that could be created using both non-GE and GE cotton varieties that are no longer subjectto the plantpestprovisions of the Plant Protection Act and 7 CFRpart 340 is hypothetical and purely speculative. 

### 8. The degree to which the action mayadversely affect districts, sites, highways, structures,
orobjects listed in or eligible for listing in the National Registerof Historic Places or may cause loss ordestruction of significantscientific, cultural, or historical resources. A determination ofnonregulated status ofCOT67B cotton will not adversely impact cultural resources on tribal properties. Any farming activitythat maybetaken by farmers
on tribal lands are only conducted atthe tribe's request; thus, the tribes have control over anypotential conflictwith cultural resources on tribal properties. A determination of nonregulated status ofCOT67B cotton would have no impact on districts, sites, highways, structures, or objects listed in oreligible for listing in the National Register of Historic Places, nor would they likely cause any loss ordestruction ofsignificant scientific, cultural, orhistorical resources. This action is limited to a determination of nonregulated status ofCOT67B 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 oruse of historic properties protected undertheNational Historic Preservation Act. In general,
common agricultural activities conducted under this action do nothave the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character oruse ofhistoric properties. For example, there is potential for audible effects on the use and enjoyment ofa historic propertywhen
common agricultural practices, such as the operation oftractors and other mechanical equipment, are conducted close to such sites. A built-in mitigating factor for this issue is that virtually all ofthe methods involved would only have temporary effects on the audible nature ofa site and can be ended at anytime to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionally, these cultivationpractices are alreadybeing conducted throughout the cotton production regions. The cultivation ofCOT67B cotton does not inherently change any ofthese agronomic practices so as to give rise to an impact underthe NHPA.

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### 9. The degree to which the action may adversely affectan endangeredorthreatenedspecies
or its habitat that has been determined to be critical under the EndangeredSpeciesAct of 1973. As described in Chapter 4 ofthe EA, APHIS has analyzed the potential for effects from cultivation ofCOT67B 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 reviewingpossible effects ofa determination of nonregulated status ofCOT67B cotton, APHIS has reached a conclusionthat a determination ofnonregulated status would have no effect on federally listed threatened
orendangered species and species proposed for listing, or on designated critical habitat or habitat proposedfor designation. 

### 10. Whether the action threatens a violation of Federal, State, orlocal law or requirements imposed for theprotection of the environment. Theproposed action would be in compliance with all federal, state, and local laws. Because the agencyhas concluded that COT67B cotton is unlikely to pose a plantpest risk, a determination ofnonregulated status ofCOT67B cotton is a response that is consistent with the plantpest provisions ofthe PP A, the regulations codified in 7 CFR part 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. Syngenta submitted a summary ofits safety and nutritional assessmentto FDA for COT67B cotton. In February2009, FDA completed Syngenta's consultation on COT67B cotton regarding the safety and nutritional assessment for the cotton andhad no further questions (US-FDA No.000112)(see Appendix A ofthe EA). Tolerance exemptions and conditional pesticide registrations have been granted for the plant-incorporatedprotectant in COT67B cotton and the genetic material necessary for its production. On July 16, 2008, the EPA granted an exemption from the requirement ofa tolerance for residues of FLCrylAb in oron food and feed commodities ofcotton (73 FR40760-40764). 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, orlocal permits that are neededprior to the implementation ofthis action.

NEPA Decision and Rationale I have carefullyreviewed the EAprepared for this NEPA determination and the input from the public involvementprocess. I believe that the issues identified in the EA are best addressedby 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 plantpestprovisions ofthe Plant Protection Act.

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the agencybelieves would fulfill its statutorymission and responsibilities, giving consideration to economic, environmental, technical and other factors." The preferred alternative has been selected for implementation based onconsideration ofa number ofenvironmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1)

16it allows APHIS to fulfill its statutorymission 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 pestprovisions ofthe PPA, the regulations codified at 7 CFRpart 340, and thebiotechnology regulatorypolicies 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 ofGenetically 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 byJ. 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 theirproduction in COT102 XCOT67B cotton.

USDA-APHIS (2009). Plant pestrisk 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 ofGeneticallyEngineered 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/.

17Attachment Finding ofNo 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-daypublic review and comment period. Comments were required to bereceived on orbefore 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 attachmentto one ofthe comment documents. No new issues, alternatives
or substantive new information were identified in any ofthe comments received byAPHIS. The 7 comments expressed opposition to a determination ofnonregulated status ofCOT67B cotton, but did not change the analysis provided in the PPRA ordraft EA. these individuals did not mention their specific disagreement with APHIS' analyses ofCOT67B cotton detailed in the EA
orthe PPRA; rather, they expressed their general opposition to genetically modified organisms (GMOs) orGE 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 notprovide 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 byAPHIS.

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 likelythat organic farmers, orother farmers who choose not to plant transgenic varieties or sell transgenic seed, will be substantially impacted bythe 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. Accordingto the petition, agronomic trials conducted in 2005 and 2006 in a variety oflocations 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 bythe USDA National Organic Program (NOP) requires organic production operations to have distinct, defined boundaries andbufferzones to prevent unintended contact with excludedmethods 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 GEcrops so thatthe crops will flower atdifferent times, and employing adequate isolation distances betweenthe organic fields and the fields ofneighbors to minimize the chance that pollen will

18be carried betweenthe fields (Baier, 2008; Bradford, 2006; NCAT, 2003; Sundstrom et aI., 2002). Commonlyused production practices for cotton and the practical methods typically used bycotton farmers using organic methods to protect their crop under organic production (NCAT, 2003) providemanymeasures that greatlyreduce the likelihood ofaccidental 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 easilybythe wind. Some insect cross-pollination can occur ifsuitable insects are present and in large enough numbers (Fryxell, 1979; McGregor, 1976). However, pollen movementby insects is considered to be low (McGregor 1976). A majority offield-based research with cotton shows an outcrossing rate of 10% or less within 1meter 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 ofseparation 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 of5331 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 ofadequate isolation distances between GE and non-GE cotton fields, the planting ofborder orbarrierrows to intercept pollen, employing natural barriers to pollen movement such as tree lines, and staggering planting dates, a determination ofnonregulated 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 andTheirWild 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 UniversityPress. BaierA (2008). Organic standards for crop production ATTRA. Retrieved December, 2010 from http://attra.ncat.org!attra-pub/PDF/nopstandard crops.pdf Bradford KJ (2006). Methods to Maintain Genetic Purity ofSeed Stock Publication 8189. University ofCalifornia, Division ofAgriculture and Natural Resources. Retrieved from http://ucanr.org!freepubs/docs/8189.pdf Fryxell PA. (1979) The NaturalHistory of the Cotton Tribe (Malvaceae, tribe Gossypieae). College Station and London: Texas A&M University Press Hartman HT, PlockerWJ, and Kofranck AM. (1981) Plant Science: Growth, Development and Utilization of CultivatedPlants. Englewood Cliffs, NJ: Prentice-Hall, Inc.

19Llewellyn D and Fitt G. (1996) Pollen dispersal from two field trials oftransgenic cotton in the Namoi Valley, Australia. MolecularBreeding, 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. SubmittedbyJ. 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 ofPollen Dispersal by Insects from a Field Test ofGenetically Engineered Cotton. Journal 

## 0/ EconomicEntomology, 84, 1943-1950. USDA-APHIS (2011). Syngenta Biotechnology, Inc. Petition (07-lOB-Olp) for Determination of Nonregulated Status ofLepidopteran-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 onhuman skin. Response: As discussed in Chapter IV ofthe EA, based on the analysis offield and laboratory data and scientific literatureprovidedby 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.

TheEPA concluded that human exposure to Cryproteins as the result ofskin contact with plants is not likely, due to the containment ofCryproteins 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 notpresent
a human health risk (FDA, 2011). Additionally, the CrylAbprotein, like several other similar Cryproteins, was granted apermanent exemption from the requirement oftolerancebythe 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 lackofsimilaritybetween CrylAb and any known toxin (beyond otherCryproteins) orallergen following a bioinformatics query; b) the recognition by FDA and EPA that CrylAb is unlikely to pose a significant human health risk; c)

20the absence ofCrylAb in COT67B fiber separated from seed; and d) the fact that the processing ofcotton fiber priorto incorporation into various products results in little orno plantprotein persistence ofanykind (Davies et aI., 2001; ICAC, 2000; Syngenta, 2007). Thus, direct dermal exposure to COT67B fiber is unlikely to result in a human health riskbecause 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 HardyA (2001) Opinion on GeneticallyModified 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/crylf-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 ofan 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 byJ. N. Reed, Regulatory Affairs Manager. Syngenta Biotechnology, Inc. (See Table http://w'WW.aphis.usda.govlbiotechnologyinot reg.htmn.

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