Syngenta Biotechnology, Inc. 

Insect Resistant MIR162 Corn 

OEeD Unique Identifier: SYN-IR162-4 

Final Environmental Assessment 

March 2010 

Agency Contact 

CynthiaEck 

Document Control Officer 

Biotechnology Regulatory Services 

USDA,APHIS 

Riverdale, MD 20737 

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Mention of companies or commercial products in this report does not imply recommendation or endorsement 

by the US. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants 

the standard of any product mentioned. Product names are mentioned solely to report factually on available 

data and to provide specific information. 

This publication reports research involving pesticides, All uses of pesticides must be registered by 

appropriate Statc and/or Federal agencies before they can be recommended. 

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Table of Contents 

I. SUMMARY 3 

II. PURPOSE & NEED 3 

III. INTRODUCTION 6 

IV. AFFECTED ENVIRONMENT 7 

A. Corn 7 


B. Agricultural Production of Corn 8 


C. Corn Lepidopteran Pests 9 


V. AL TERNA TIVES 10 


A. No Action: Continuation as a Regulated Article 10 


B. Grant nonregulated status to MIR162 corn, "in wbole"­


Preferred Alternative: Determination tbat MIR162 


Corn is No Longer a Regulated Article 11 


VI. ENVIRONMENTAL CONSEQUENCES 11 


A. No Action 12 


1. Corn 12 


2. Agricultural Production of Corn 12 


3. Corn Lepidopteran Pests 12 


B. Preferred Alternatives 13 


1. Corn 13 


2. Agricultural Production of Corn 14 


3. Potential Impacts ofLine MIR162 Corn on Insect Control 


Practices 14 


4. Organic and Other Non-transgenic Corn Production 15 


5. Potential Impact on Non-target Organisms, Including 


Beneficial Organisms and Threatened or Endangered Species 17 


6. Cumulative Effects 20 


7. Socioeconomic Analysis 22 


C. Consideration of Executive Orders, Standards and 


Treaties Relating to Environmental Impacts 27 


VII. REFERENCES 30 


VIII. PREPARERS, REVIEWERS, CONSULT A nONS, 

AGENCY CONTACT 36 

IX. APPENDIX 

Appendix I. Environmental and Human Health 

37 

Appendix II. Syngenta MIR162 Corn Forage and 

Grain Compositional Analysis 

Safety of Vip3Aa20 Protein 

39 

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I. Summary 

The Animal and Plant Health Inspection Service (APHIS), United States Department of 

Agriculture (USDA), has prepared an Environmental Assessment (EA) in response to a 

petition (APHIS Number 07-253-01p) from Syngenta Biotechnology, Inc. (Syngenta) 

regarding the regulatory status of genetically engineered (transgenic) corn resistant to 

lepidopteran insect feeding from transformation event MIR162. This corn is currently a 

regulated article under USDA regulations at 7 CFR part 340, and as such, interstate 

movements, importations, and field tests ofMIR162 corn have been conducted under 

permits issued or notifications acknowledged by APHIS. Syngenta petitioned APHIS 

requesting a determination that MIR162 corn does not present a plant pest risk, and 

therefore MIR162 corn and its progeny derived from crosses with other nonregulated 

corn should no longer be regulated articles under these APHIS regulations. 

II. Purpose and Need 

"Protecting American agriculture" is the basic charge ofthe USDA-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 varieties) can 

provide benefits to the environment, consumers, and farm income. 

Federal Regulatory Authority 

In 1986, the Federal Government's Office of Science and Technology Policy (OSTP) 

published a policy document known as the Coordinated Framework for the Regulation of 

Biotechnology. This document specifies three Federal agencies that are responsible for 

regulating biotechnology in the U.S.: USDA's APHIS, the Environmental Protection 

Agency (EPA), and the U.S. Department ofHealth and Human Services' Food and Drug 

Administration (FDA). APHIS regulates genetically engineered (GE) organisms under 

the Plant Protection Act of2000. 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). FDA 

regulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic Act. 

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 distribution of 

bioengineered food. Together, these agencies ensure that the products of modern 

biotechnology are safe to grow, safe to eat, and safe for the environment. USDA, EPA, 

and FDA enforce agency-specific regulations to products ofbiotechnology that are based 

on the specific nature of each GE organism. Products are regulated according to their 

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intended use and some products are regulated by more than one agency. 

USDA Regulatory Authority 

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

States' agriculture and environment using a dynamic and science-based regulatory 

framework that allows for the safe development and use of genetically engineered 

organisms. APHIS regulations at 7 Code ofFederal 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 considered a regulated article if the donor organism, 

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

one ofthe taxa listed in the regulation (7 CFR part 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 sufficient information 

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

A person may petition the agency to evaluate submitted data and determine that a 

particular regulated article is unlikely to pose a plant pest risk, and, therefore, should no 

longer be regulated under 7 CFR part 340.6 entitled "Petition for Determination of 

Nonregulated Status." The petitioner is required to provide information under § 

340.6(c)(4) related to plant pest risk that the agency uses 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 when APHIS determines that it is unlikely to pose a plant pest risk. 

Syngenta Biotechnology, Inc. (hereafter "Syngenta") ofResearch Triangle Park, NC 

submitted a petition to APHIS seeking a determination of nonregulated status for their 

transgenic event MIR162 com (hereafter "MIR162 com"). The MIR162 com has been 

engineered to express a bacterial protein Vip3Aa20 from Bacillus thuringiensis that is 

toxic to a certain lepidopteran insect pests. This com is also engineered to express 

another protein, phosphomannose isomerase (PMI) from Escherichia coli, which was 

used as a selectable marker to identify com seedlings containing Vip3Aa20 gene during 

the development ofMIR162 com. The MIR162 com is currently regulated under 7 CFR 

part 340. This com has been considered a regulated article because it was genetically 

engineered with regulatory sequences derived from plant pests and because a plant pest 

was used as a vector agent to deliver those sequences to the plant. Interstate movements 

and field trials ofthe MIR162 com have been conducted under permits issued or 

notifications acknowledged by APHIS. 

Under the authority of 7 CFR part 340, APHIS has the responsibility for the safe 

development and use of genetically engineered organisms under the provisions ofthe 

Plant Protection Act. APHIS must respond to petitioners that request a determination of 

the regulated status of genetically engineered organisms, including genetically 

engineered crop plants such as MIR162 com. If a petition for nonregulated status is 

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submitted, APHIS must detennine whether the genetically engineered organism is 

unlikely to pose a plant pest risk. 

As a Federal agency subject to compliance with the National Environmental Policy Act 

(NEPA)! (42 U.S.C. 4321 et seq.), APHIS has prepared this EA to consider the potential 

environmental effects of this proposed action (granting nonregulated status) and the 

reasonable alternatives to that action consistent with NEP A implementing regulations (40 

CFR §§ 1500-1508, 7 CFR part 1 (b), and 7 CFR part 372) and the USDA and APHIS 

NEP A implementing regulations and procedures. This EA has been prepared in order to 

specifically evaluate the effects on the quality ofthe human environment! that may result 

from the deregulation of the MIR162 com. 

u.s. Environmental Protection Agency and Food and Drug 

Administration Regulatory Authority 

The MIR162 com is also subject to regulation by other agencies. The U.S. 

Environmental Protection Agency (EPA) is responsible for regulation of pesticides under 

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. §136 et seq.). 

FIFRA requires that all pesticides be registered before distribution, sale, and use, unless 

exempted by EPA regulation. Before a product is registered as a pesticide under FIFRA, 

it must be shown that when used in accordance with the label, it will not result in 

unreasonable adverse effects on the environment. Accordingly, EPA grants pennits to 

allow a pesticide producer to test a new pesticide product outside the laboratory under 

Experimental Use Pennits (EUPs), which are used for large-scale (more than 10 acres of 

land or 1 acre of water) testing of efficacy and gathering of environmental fate, 

ecological effects, and crop residue chemistry (40 CFR part 172). 

Syngenta obtained an experimental use pennit from EPA that allowed for broad-scale 

field testing of the MIR162 com; this pennit was granted on March 26, 2007 and was in 

effect through March 31, 2008 (72.FR 34009-34010). On July 23,2008 EPA announced 

receipt of a petition from Syngenta to conditionally register three pesticide products 

containing the new active ingredient Vip3Aa20 and the genetic material necessary for its 

production in com (73 FR 42799-42801). These pesticide products included MIR162 

and the two com hybrids Btl 1 x MIR162 and Btl 1 x MIR162 x MIR604 (Btl 1 and 

MIR604 contain the additional insecticidal protein active ingredients Cry1Ab and Cry3A, 

respectively, and both have previously been deregulated by APHIS and registered as 

plant-incorporated protectants by EPA). On April 30, 2009, EPA announced the 

approval ofthese conditional registrations involving MIR 162 and the hybrids (74 FR 

19956-19957). 

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

the relationship of people with that environment" (40 CFR §150S.14) 

2 Cry proteins are crystal proteins that are produced within the spores ofBt bacteria. A majority of 

deregulated Bt crops currently available in the U.S. market express Cry proteins. 

I 

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Under the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. §301 et seq.), 

pesticides added to (or contained in) raw agricultural commodities are prohibited unless a 

tolerance or exemption from tolerance has been established. EPA establishes residue 

tolerances for pesticides under the authority of the FDCA. The FDA enforces the 

tolerances set by the EPA. On April 4, 2007 EPA established a temporary exemption 

from the requirement of a tolerance for Vip3Aa20 residues in maize commodities, 

pursuant to §408(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §346a(d). 

On August 6, 2008, EPA granted exemption from the requirement of a tolerance for 

residues ofB. thuringiensis Vip3Aa proteins (including the Vip3Aa20 variant) in or on 

food and feed commodities of com (73 FR 45620-45624). On May 14, 2004, EPA 

granted an exemption from the requirement of a tolerance for residues in or on plant 

commodities of phosphomannose isomerase and the genetic material necessary for its 

production in all plants when applied/used as plant-incorporated protectant inert 

ingredients (69 FR 26770-26775). With the publication ofEPA's registration document, 

APHIS will use this finalized information to provide additional scientific support to its 

consideration ofpotential environmental impacts. 

FDA, which has primary regulatory authority over food and feed safety, published a 

policy statement in the Federal Register on May 29, 1992 (57 FR 22984-23005) 

concerning regulation of products derived from new plant varieties, including those 

genetically engineered. Under this policy, FDA uses what is termed a consultation 

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

(e.g. labeling) are resolved prior to commercial distribution of a bioengineered food. 

Syngenta submitted a summary of their safety assessment to FDA on August 3, 2007, and 

additional information on December 17, 2007 and March 31, 2008. Syngenta's 

submissions to FDA indicated that food and feed derived from com event MIR162 are as 

safe (Appendix I in this EA) and nutritious as food and feed derived from conventional 

com (Appendix II in this EA). FDA completed their consultation on MIR162 on 

December 9,2008 and concluded that it had "no further questions concerning grain and 

forage derived from com event MIR162" (FDA BNF No. 000113). 

Public Involvement 

APHIS-BRS routinely seeks public comment on draft environmental assessments 

prepared in response to petitions to deregulate GE organisms. APHIS-BRS does this 

through a notice published in the Federal Register. This EA, the petition submitted by 

Syngenta, and APHIS's plant pest risk assessment, were made available for public 

comment for a period of 60 days. Comments that were received within the 60-day 

comment period were fully analyzed and used by APHIS to determine ifthe petition to 

deregulate the MIR162 com should be granted. 

Decision to Be Made 

APHIS will use the information from this EA, and the comments received, to assist 

APHIS' decisionmaker to determine whether to grant nonregulated status, or to continue 

to regulate MIR162 com under the regulations at 7 CFR part 340, or that an 

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Environmental Impact Statement is necessary prior to the decision to grant nonregulated 

status to this com variety. 

III. Introduction 

Com is susceptible to attack by a variety ofinsects (Table 1, pg. 12 in petition) from the 

time it is planted until it is consumed as food or feed. Syngenta has developed a GE com 

hybrid, named MIR162, that is resistant to the feeding damage caused by com earworm 

(Helicoverpa zea), fall armyworm (SpodopteraJrugiperda), black cutworm (Agrotis 

ipsilon), and western bean cutworm (Stria costa albicosta) larvae that are not controlled 

well with existing technology. This insect resistance in MIR162 comes from a bacterial 

gene called Vip3Aa20 (Vip = Vegetative insecticidal protein). The MIR162 com also 

contains manA gene from E. coli encoding the enzyme phosphomannose isomerase 

(PMI), which was used as a selectable marker during transformant selection. The manA 

gene expression confers no other benefit to the regenerated transformed com plant. 

The family ofVip3Aa proteins, in which Vip3Aa20 belongs, are produced by the 

bacterium B. thuringiensis (hereafter "Bt") (Estruch et al. 1996) that act as toxins to kill 

insect prey (Estruch et al. 1996; Schnepf et al. 1998). Vip3Aa proteins are similar to 

certain Cry proteins2 (Hafte and Whiteley 1989) and are demonstrated to have toxic 

effects only on certain insects (Table 2.1 on p. 23 in Carozzi and Koziel 1997). The 

mechanism by which Vip proteins exert their insecticidal activity has been studied and 

found to be similar, but not identical, to that which has been described for the Bt Cry 

proteins that are contained in several commercial insecticide formulations and APHIS 

deregulated GE plants engineered for insect resistance (USDA-APHIS, 2010, see 

Transgenic phenotype column in Table: examples include coleopteran-, or lepidopteranresistant, com borer (ECB) resistant, com rootworm resistant, Colorado potato beetle 

resistant). The Vip and Cry proteins bind to different receptors in the insect (Lee et al. 

2003), and the insecticidal activity ofVip3Aa proteins is limited to species within 

selected families ofthe order Lepidoptera (Table 27, pg. 74-75 in Syngenta, 2007). For 

example, MIR162 alone has no activity against European com borer (Ostrinia nubilalis) 

but is efficacious in limiting feeding damage caused by the other four insect pests (com 

earworm, fall armyworm, black cutworm, western bean cutworm) (Figure 21, pg. 76 in 

petition); whereas the Btl 1 GE com variety (containing a Cry protein) is highly 

efficacious against European com borer, but it has limited or no activity against the other 

four insects. USDA, APHIS has previously granted nonregulated status to 11 insect 

resistant GE com varieties containing Cry proteins from Bt (USDA-APHIS 2009). 

The MIR162 com has been field tested in the United States since 1999 as authorized by 

APHIS. Associated notifications acknowledged and permits issued by APHIS are listed 

in Appendix A ofthe petition (pg. 127-128). The list compiles more than 20 test sites in 

diverse regions ofthe U.S. including the major com growing area ofthe Midwest and 

winter nurseries in Hawaii. Field tests conducted under APHIS oversight allow for 

evaluation in agricultural settings under confinement measures designed to minimize the 

likelihood of persistence in the environment after completion ofthe field trial. Under 

confined field trial conditions, applicants gather data for agronomic characteristics and 

7 
product perfonnance in response to insects, disease or other stresses. These data are also 

valuable to APHIS as the agency assesses the potential for a new com variety to pose a 

plant pest risk. APHIS' evaluation ofthis data may be found in the APHIS plant pest risk 

assessment (USDA-APHIS 2009). 

IV. Affected Environment 

A. Corn 

Com is primarily grown in wann temperate climates (Nonnan et al. 1995). Field com is 

the leading agricultural production crop globally, with the 2009 growing season expected 

to yield 789 million metric tons of grain (lCG 2009). Com is grown for animal feed, 

human food, vegetable oil, high fructose com syrups, starch, fennentation into ethanol, 

and a multitude ofindustrial uses (Hoeft et aI., 2000). 

Zea mays L. subsp. mays, known as maize throughout the world, and as com in the U.S., 

is a member of the Maydeae tribe of the grass family, Poaceae. It is an annual plant with 

separate male and female flowers on each plant (monoecious) that requires human 

intervention for its seed dispersal and propagation. Additional infonnation on the 

biology of com can be found within the Organisation for Economic Co-Operation and 

Development consensus document (OECD 2003). 

Com is predominantly a wind-pollinated outcrossing species (OECD 2003). Transgenes 

in crops have the potential to move between sexually compatible populations, and more 

so in com being a wind-pollinated plant with separate male and female flower bearing 

structures (inflorescences). Gene flow rate between com populations is extremely 

variable depending on the spatial, temporal, genetic and environmental factors (Brookes 

and Barfoot et ai. 2004; Messegue et ai. 2006). Yet, available experimental evidence 

indicates that gene flow rates drop substantially (1 %) beyond 20 meters (Henry et ai. 

2003; Ma et ai. 2004; Messeguer et ai. 2006). To maintain varietal purity, the AOSCA 

(Association of Official Seed Certifying Agencies) recommends 200 meters isolation for 

nearby com popUlations as the foundation class of certified seed production (AOSCA 

2003). 

The insect resistance trait ofMIR162 has the potential to enhance the fitness ofwild and 

weedy relatives if gene flow occurs between the MIR 162 com crop and wild or weedy 

com populations. However, there are no large populations or widely distributed wild 

com plants (teosinte) in the U.S., and even the few non-weedy feral popUlations in the 

U.S. have limited opportunity for outcrossing with transgenic com cultivars (see USDAAPHIS 2009). 

Com is not weedy, and does not persist outside cultivated areas (USDA-APHIS 2009). 

APHIS knows of no reports in which com propagated vegetatively under field conditions, 

since the only known propagation method for com is through seed gennination. Com 

seed is sensitive to cold and typically does not survive freezing winter conditions. 

Consequently, com has no innate donnancy (Simpson 1990; Table 18, pg. 61 Syngenta 

8 
2007). Even if com seeds from a previous year's crop overwinter and germinate the 

following year, manual or chemical measures are available and are often applied to 

remove these volunteers (see Table 1 in Wright et al. 2009). 

B. Agricultural Production ofCorn 

The U.S. accounts for about 41 % of global com production (Bange 2007). Com is the 

largest crop grown in the U.S. in terms of both volume and value. Approximately 86 

million acres were planted in 2008 growing season, yielding 12 billion bushels (305 

million metric tons) with a gross crop value of $47 billion ($3.9Ibushel) (USDA-NASS 

2008a; USDA-NASS 2008b). The upper Midwest region ofthe U.S. provides an ideal 

combination oftemperature, rainfall, and soil type for the cultivation of com. Iowa, 

Illinois, Nebraska, Minnesota, Indiana, Ohio, Wisconsin, Missouri, Kansas, and South 

Dakota are major com growing states. Production in these ten states accounts for 77% of 

total annual production (USDA-NASS 2008b). 

The use of com as a source of fuel ethanol has increased dramatically over the past two 

years and is expected to continue to increase as the U.S. focuses on employing renewable 

sources of energy. The Federal Energy Act of2005 includes a nationwide renewable 

fuels standard (RFS) that will result in the use of more than 7.5 billion gallons of ethanol 

and biodiesel by 2012 (42 USC 15801, page 1069). Over 20% of commodity com in 

2007 was used for ethanol production (Trostle 2008; USDA-ERS 2008). By 2010, U.S. 

ethanol production could displace the equivalent of 311 ,000 barrels ofimported crude oil 

per day (GAO, 1996). 

The U.S. is by far the world's largest exporter of com, and in 200312004 through 

2007/2008 accounted for on average 60% ofworld com exports (USDA-ERS 2009a). 

Total U.S. agricultural exports in 2006 were valued at $71 billion, 10% ofwhich was 

attributable to com (Brooks 2007). Agricultural exports generate employment, income, 

and purchasing power in both farm and nonfarm sectors ofthe economy. Production from 

almost one-third of U.S. cropland moved into export channels in 2005 and generated 

$166.1 billion in business activity (Food Institute 2007). Technology advances, such as 

those attributed to GE crops, increase agricultural productivity and keep domestic 

growers competitive in the global market (NCRA 2010). 

Based on USDA survey data, adoption of genetically engineered insect-resistant com 

increased from zero percent ofthe U.S. com acreage in 1996 to 63 percent in 2009 

(USDA-ERS 2009). The rapid commercialization of GE insect-resistant com (IR com) 

varieties by com growers is attributed to benefits offered by those com varieties in terms 

ofreduced conventional insecticide use, increased profits, and improved grain quality 

(Fernandez-Conejo and Caswell 2006). 

In addition to insect resistant (IR) com cultivation, U.S. farmers have also planted GE 

herbicide tolerant (HT) com varieties since 1996. A few GE com cultivars contain both 

IR (European com borer resistance, com rootworm, etc.) and HT traits (glyphosate 

tolerance, imidizolinone tolerance). Among GE varieties of com (IR and HT com 

cultivars), 68% of all GE com varieties planted contained a herbicide tolerant (HT) trait 

9 
(USDA-ERS 2009b). Herbicides were applied to 97 percent of the GE and non-GE com 

planted acreage in 2005, with atrazine, glyphosate, S-metolachlor and acetochlor being 

applied to 66%, 31 %,23% and 23% of planted com acres, respectively (USDA-NASS 

2006). MIR162 com is not expected to alter current or future com weed control 

practices. The main introduced trait in MIR162 is expected to provide resistance to 

certain groups of insect pests. Therefore, except for change in insect resistance 

management, all other agricultural practices of the MIR162 com, including com weed 

control practices, are not expected to be different from those of conventional com 

cultivation. 

According to USDA-ERS (2009) report, 15% (~13 million acres) of the U.S. com 

acreage was planted with the non-GE com varieties in 2009. Likewise, according to 

USDA-ERS' latest data on organic com production, less than 1 percent (0.16%) of com 

crop area in 2005 was devoted to organic com (USDA-ERS 2009c). Under USDA 

National Organic Program regulations (USDA-AMS 2010), the use of synthetic 

pesticides, fertilizers, and genetically engineered crops is strictly limited (7 CFR part 

205.105 and definition, "excluded methods"). As a result, MIR162 com is not approved 

for use in organic production systems because it is genetically engineered. Maintaining 

the integrity of the organic production process is important to producers of organic com. 

There are many practices organic producers use to prevent movement of GE com or the 

pollen from GE com into their organic production fields (Bradford 2006, Schienmann 

2003, Ziegler 2000). Growers may chose to plant only organic seed; plant earlier or later 

than neighboring farmers who may be using GE crops, ensuring that the flowering times 

between GE and organically produced crops will differ, thus minimizing the change of 

pollen movement between fields; and also employ adequate isolation distances between 

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

carried between the fields. Additionally, organic growers must maintain records to show 

that production and handling procedures comply with USDA organic standards (7 CFR 

part 205). 

C. Corn Lepidopteran Pests 

Com crop is susceptible to attack by a variety of insects throughout its life cycle (see pg. 

12 in Syngenta 2007). Two of the five most widespread and damaging insects of com in 

the U.S. Com Belt are the European com borer and com rootworms (Hoeft, et al. 2000). 

Although a few conventional insect control practices (chemical and microbial 

insecticides, crop rotation etc.) are available for com insect pests, the stalk boring insects 

such as the European com borer have been difficult to control and in some areas, it is not 

profitable to use chemical control against such insect pests (Martin and Hyde 2001). 

Conventional insecticide and crop rotation practices have been proven effective in 

controlling the damage caused by com rootworms (Ma et aI., 2009). Prior to the 

introduction of GE rootworm-protected Bt varieties in 2003, an estimated 14 million 

acres of com were treated annually with conventional insecticides to control com 

rootworms (Ward et al. 2005); insecticides for rootworm control accounted for the largest 

single use ofinsecticides in the U.S. Treatment of com rootworm with chemical 

10 
pesticides may have decreased by 34%, the difference in acreage between use of 

European com borer protected com and com rootworm protected Bt com between 2003 

(when CRW com was first available) and 2009 (USDA-ERS 2009c). The use of 

conventional insecticide treatment is less effective for some com insect pests, such as 

com earworm (Hoeft et a1. 2000), as some of these com pests may enter areas shielded 

from aerial chemical applications; com earworm follows the silk channel and enters the 

protected recesses of the com ear (Burkness et al. 2009) . 

In addition to direct damage caused by feeding on plant tissue, com insect pests are also 

known to play an important role in the transmission and dissemination of pathogenic 

organisms during com development (Dowd 1998). For example, it has been shown that 

insect feeding damage enhances mycotoxin contamination of com crop (Williams et a1. 

2002) that have toxic and carcinogenic effects in humans and animals (see Wu 2006 for 

details). The introduction ofGE Bt com varieties has provided growers solutions to 

some of the above-mentioned pest problems by limiting damage caused by certain 

lepidopteran insect pests (Hurley et a1. 2006) and fungal diseases (Wu 2006) without 

posing any significant risk to the environment or to human health (Mendelsohn et a1. 

2003). 

v. Alternatives 

This EA analyzes the potential environmental consequences of a proposal to grant 

nonregulated status to the MIR162 com. In order forMIR162 com to be granted 

nonregulated status, APHIS must determine that this GE com variety is unlikely to pose 

a plant pest risk. The analysis by APHIS in its plant pest risk assessment (USDAAPHIS, 2009) demonstrates that there were sufficient data to determine that the MIR162 

com is unlikely to pose a plant pest risk and therefore is eligible for nonregulated status. 

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

in whole or in part." Because APHIS has found that the MIR162 com is unlikely to pose 

a plant pest risk, the only action alternative considered in this EA is to grant nonregulated 

status "in whole" to the com line under consideration. An "in part" deregulation can be 

given if there is a plant pest risk associated with some, but not all lines requested in a 

petition. The petition for the MIR162 com only requested APHIS to grant nonregulated 

status to a single com event, therefore, an "in part" determination is not an appropriate 

consideration. Thus, only two alternatives will be considered in this EA: (1) no action, or 

(2) to grant nonregulated status to MIR162 com "in whole." APHIS has assessed the 

potential for environmental impacts for each alternative in the "Environmental 

Consequences" sections below. 

A. No Action: Continuation as a Regulated Article 

Under the "no action" alternative, APHIS would deny the petition. MIR162 com and its 

progeny would continue to be regulated under 7 CFR part 340. Permits issued or 

notifications acknowledged by APHIS would still be required for introductions of 

MIR162 com and measures to ensure physical and reproductive confinement would 

11 
continue to be implemented. APHIS might choose this alternative ifthere were 

insufficient evidence to demonstrate the lack of plant pest risk from the unconfined 

cultivation of the MIR162 com and its progeny. 

Under this no action alternative, growers and other parties who are involved in 

production, handling, processing or consumption of com would continue to have access 

to existing deregulated GE insect resistant com as well as conventional com varieties. 

However, growers would not have widespread access to the MIR162 com since it would 

continue to be regulated under Part 340. This alternative is not the preferred alternative 

because APHIS' evaluation ofMIR162 data in the plant pest risk assessment 

demonstrates that the MIR162 com is unlikely to pose a plant pest risk (USDA-APHIS, 

2009). Choosing this alternative would hinder the purpose and need of APHIS to allow 

for the safe development and use ofGE organisms given that the MIR162 com is 

unlikely to pose a plant pest risk. 

B. Grant nonregulated status to MIR162 corn, "in whole"- Preferred 

Alternative: Determination that Syngenta MIR162 Corn is No Longer a 

Regulated Article 

Under this alternative, MIR162 com and its progeny would no longer be considered 

regulated articles under 7 CFR part 340. Permits or notifications acknowledged by 

APHIS would no longer be required for introductions in the United States and its 

territories ofthe MIR162 com or its progeny. MIR162 com is eligible for nomegulated 

status because APHIS has determined that this GE organism is unlikely to pose a plant 

pest risk (USDA-APHIS 2009). APHIS might choose this alternative ifthere was 

sufficient evidence to demonstrate the lack ofplant pest risk associated from the 

unconfined release of this insect resistant com event. 

Under this alternative, growers may have future access to MIR162 com and progeny 

derived from this variety ifthe developer decides to commercialize this insect resistant 

com variety. In addition, growers and other parties who are involved in production, 

handling, processing or consumption of com would continue to have access to existing 

deregulated GE insect resistant com as well as conventional com varieties. If 

commercialized, MIR162 com will likely be introduced in areas where com is currently 

grown and is not expected to alter the current range of com cultivation in the US. 

APHIS has chosen Alternative B as the preferred alternative because APHIS has 

determined that MIR162 com is unlikely to pose a plant pest risk (USDA-APHIS 2009). 

By granting nomegulated status to MIR162 com, the purpose and need to allow the safe 

development and use of GE organisms is met. 

Alternatives Considered but Rejected from Further Consideration 

Geographic restrictions 

APHIS considered geographic restrictions based upon geographic variation in plant pest 

risk. As presented in APHIS plant pest risk assessment for MIR162 com, there is no 

12 
geographic differences in the plant pest risks for MIR162 com (USDA-APHIS 2009). 

This alternative was rejected and not analyzed in detail because MIR162 com is unlikely 

to pose a plant pest risk and therefore, APHIS will have no regulatory authority over 

MIR162 com and will be unable to impose regulatory restrictions on this GE com 

variety. 

VI. Environmental Consequences 

According to APHIS regulations at 7 CFR part 340, an organism is no longer subject to 

regulatory requirements when it is demonstrated not to present a plant pest risk. Under 

the regulations, APHIS is required to render a determination on a petition for 

nonregulated status. The analysis ofpotential environmental consequences in the 

following sections address the potential impact to the human environment from the 

alternatives analyzed in this EA, namely taking no action and granting nonregulated 

status to MIR162 com, "in whole." 

SCOPE OF THE ENVIRONMENTAL ANALYSIS 

Although the preferred alternative would allow for new plantings ofMIR162 com to 

occur anywhere in the U.S., APHIS limited the environmental analysis to those areas that 

currently support com production. To determine areas of com production, APHIS used 

data from the National Agricultural Statistics Service (NASS) 2009 Census of 

Agriculture to determine where com is produced in the United States (USDA-NASS 

2009), accessed 3/5/2010). According to the 2007 Censuses of Agriculture, 49 states 

produce com grain in the US. 

A. No Action 

Under the "no action" alternative, MIR162 com hybrids would continue to be a regulated 

article. APHIS' assessment of environmental consequences under the no action 

alternative is described below. 

A-I. Corn 

Under the 'no action' alternative, conventional and GE transgenic com hybrids crop 

husbandry will remain unchanged and MIR162 com hybrids will remain a regulated 

article. 

The food/feed nutritional and safety assessment for the MIR162 com has been reviewed 

by the FDA. Under Federal Food, Drug, and Cosmetic Act (FFDCA), it is the 

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

safe and properly labeled. Food and feed derived from the MIR162 com must be in 

13 
compliance with all applicable legal and regulatory requirements. FDA completed their 

consultation on MIR162 on December 9,2008 and concluded that it had "no further 

questions concerning grain and forage derived from com event MIR 162" (FDA BNF No. 

000113). 

APHIS' assessment of the safety of this product focuses on its potential to pose a plant 

pest risk, and that analysis is based on the comparison ofthe GE com to its non-GE 

counterpart (USDA-APHIS 2009). Based on the assessment offield and laboratory 

evidence provided in Syngenta's petition, accompanying scientific literature and safety 

data available on earlier insect-resistant GE com hybrids, APHIS has concluded that 

MIR162 com would have no significant impacts on human or animal health. 

A-2. Agricultural Production ofCorn 

Conventional and GE com production occurs on land that is dedicated to crop production. 


Most com is planted in agricultural fields that have been in crop production for years. 


Most ofthe com acreage in the U.S. is planted to GE com hybrids. Of the total 


com acres planted in 2008, 85% were GE com hybrids that were either herbicide tolerant, 


insect resistant, or both (USDA-ERS 2009). Likewise, according to USDA-ERS latest 


data on organic com production, in 2005 less than 1 percent (0.16%) of com crop area 


was devoted to organic com (USDA-ERS. 2009c). 


Conventional production practices that use GE varieties will likely still dominate in terms 


of acreage, or perhaps increase in acreage (Fernandez-Cornejo Caswell 2006; APHIS 


received four new petitions for non regulated status in 2008/2009 for com varieties), 


without granting nonregulated status to MIR162 com under the "no action" alternative. 


The availability of conventional, GE and organic com seed varieties will likely remain 


the same under the "no action" alternative, including MIR162 com hybrids remaining 


unavailable for commercial use. Com is currently produced in 49 US states (USDA­


NASS 2008), and under the "no action" alternative, based upon current com production 


practices and available information and trend data provide by USDA-ERA (2009 a-c) and 


USDA- NASS (2008), it is reasonable to expect this range of production wi11likely 


remain unchanged. 


Yield losses due to weeds and diseases were substantial until the introduction of crop 


protection chemicals in the 1960s (Perrin, 1997; Giannessi, 2008). Weeds compete with 


crops for light, nutrients, water, and other growth factors. The large-scale commercial 


cultivation ofGE herbicide tolerant (glyphosate tolerant) com crop acreage has steadily 


increased from 1996 accounting for nearly 68 percent of all com acreage in 2009 


(USDA-ERS 2009). Glyphosate is a highly effective, nonselective, broad-spectrum 


herbicide and in general, considered "environmentally friendly" when compared to other 


herbicides (Cerdeira and Duke 2006). Herbicides were applied to 97 percent of all com 


acreage, GE and non-GE in 2005, with atrazine, glyphosate, S-metolachlor and 


acetochlor being applied to 66%, 31 %, 23% and 23% of planted com acres, respectively 


(USDA-NASS 2006). In addition, com crops are also susceptible to attack by a variety 


ofinsects from the time of planting until consumed as food or feed. Based on USDA 


14 
survey data, adoption of genetically engineered insect-resistant com increased from zero 

percent ofthe U.S. com acreage in 1996 to 63 percent in 2009 (USDA-ERS 2009). 

Conventional insect control practices (chemical and microbial insecticides, crop rotation 

etc.) are also available to control com insect pest damage to GE and non-GE com 

varieties. 

Under the "no action" alternative, herbicides and insecticides will still be used alone or in 

combination and selected based on their effectiveness on the different weed and insect 

species in the cornfield. Human and environmental exposure to insecticides and 

herbicides will continue to occur. Different herbicides have different modes of action; 

the correct herbicide rate must be used for each in order to obtain good weed control 

results and to minimize com plant injury. APHIS has no authority under the Plant 

Protection Act to regulate pesticide (herbicide or insecticide) use. The use of pesticides is 

regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) restrictions 

administered by the EPA, which mandate registration for use of all pesticides. EPA 

includes instructions and restrictions on how pesticides can be applied, and has 

determined that there is no unreasonable environmental risk if the user adheres to the 

directions. Directions include application restrictions that minimize impacts on nearby 

environments. Violators of the regulations are liable for all negative consequences of 

their actions; therefore, farmers who use pesticides are very likely to follow its label 

restrictions, and thereby limiting any potential adverse impacts. 

If APHIS chooses the no action alternative there would be no direct impact on organic or 

other non-transgenic com farmers. The current cultivation practices are not likely to 

change and 85% of the com produced would likely continue to be planted with current 

GE com varieties (USDA-ERS 2009b). 

A-3. Corn Lepidopteran Pests 

Com is susceptible to damage by a variety ofinsect pests throughout its developmental 

cycle. Com insect pests are categorized as major and consistent pests, major and 

sporadic pests, and moderate to minor pests based on annual destructiveness and their 

geographic distribution (pg. 12 in Syngenta 2007). Yield losses due to insect pests are 

unpredictable and challenging for conventional (non-GE) com farmers and insect pest 

problems have the potential to substantially reduce crop yield and quality. Crop losses 

attributable to the European com borer (Martin and Hyde 2001) and com rootworm 

infestations (Ma et aL 2009) have been well characterized and are significant. 

The introduction ofGE Bt com cultivars which encode proteins (Cry proteins from B. 

thuringiensis) that are toxic to these species have provided U.S. com growers with a 

powerful tool for effectively protecting crop yields and environmental benefits (Marvier 

et al. 2007). The large-scale commercial cultivation ofboth insect resistant (Bt resistant) 

and herbicide tolerant (glyphosate tolerant) com crop acreage has steadily increased from 

1996, accounting for 85% of com acreage in 2009 (USAD-ERS 2009). Growers have 

substantially switched to GE com hybrids because they protect the inherent yield 

potential of com crops by reducing the grower's input costs. Under the "no action" 

15 
alternative, GE Bt com varieties and EPA approved insecticides win remain available for 

use based on the need and effectiveness against different insect species infesting 

commercial cornfields. 

Furthermore, the planting ofinsect-protected com hybrids benefits the environment by 

decreasing the use of conventional pesticide applications by more than 20 million pounds 

annually (Figure 8 in Fernandez-Cornejo and Caswell 2006; Benbrook 2004). APHISderegulated GE Bt com varieties are expected to remain available for commercial use. 

Therefore, this environmental benefit is expected to continue under the no action 

alternative. 

B. Preferred Alternative 

Under this alternative, MIR162 com would no longer be a regulated article under 7 CFR 

part 340. Permits issued and/or notifications acknowledged by APHIS would no longer 

be required for introductions ofMIR162 com. APHIS has chosen the preferred 

alternative for the proposed action because MIR162 com lacks plant pest characteristics, 

as determined in APHIS' Plant Pest Risk Assessment (USDA-APHIS 2009). APHIS' 

assessment of environmental consequences under the preferred alternative is described 

below. 

B-1. Corn 

Under this alternative, conventional and GE transgenic com hybrid crop production will 

remain unchanged and MIR162 com would be available to growers for commercial 

production. Similar to any commercially-available com hybrid, a potential impact of 

planting this GE insect resistant com hybrid may be gene introgression of MIR162 com 

into other sexually compatible or related species. APHIS evaluated the potential for gene 

introgression ofMIR162 com to sexually compatible wild relatives and considered 

whether such introgression would result in increased weediness in wild relatives. APHIS 

assessed various morphological and agronomic traits, such as seed dormancy, vegetative 

and reproductive traits, volunteer potential, disease and pest susceptibility, and the fitness 

advantage ofVip3Aa20 gene ofMIR162 com (USDA-APHIS 2009). Based on the 

scientific analysis ofdata presented in APHIS' plant pest risk assessment, APHIS has 

determined that the MIR162 com is no more likely to become a weed than other 

cultivated com varieties; it is not a plant pest; and gene flow between the MIR162 com 

and weedy and wild relatives will not occur in the United States (USDA-APHIS 2009). 

Based on the above considerations, APHIS decision to grant nonregulated status to the 

MIR162 com will not adversely impact sexually compatible wild relatives or their 

weediness potential. Overall impacts would be similar to the no-action alternative. 

A food and feed nutritional and safety assessment ofthe MIR162 com has been 

completed by the FDA. Under Federal Food, Drug, and Cosmetic Act (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 the MIR162 com must be in 

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

16 
consultation on MIR162 on December 9,2008 and concluded that it had "no further 

questions concerning grain and forage derived from com event MIR162" (FDA BNF No. 

000113). 

APHIS focused on the potential ofMIR162 com to pose a plant pest risk, and compared 

the GE com to its non-GE counterpart (USDA-APHIS 2009). From the assessment of 

laboratory evidence provided in Syngenta's petition and the accompanying scientific 

literature, APHIS has concluded that MIR162 com would have no significant impacts on 

human or animal health. Overall impacts would be similar to the no action alternative. 

B-2. Agricultural Production ofCorn 

In 2009, GE insect-resistant com varieties represented 63 percent of the com acreage in 

the US (USDA-ERS 2009). If deregulated by APHIS, MIR162 com would be an 

additional GE insect resistant com variety available to growers for commercial 

production. This com variety will likely be introduced to areas where com is currently 

grown as a replacement product for other varieties (conventional and GE) already 

available in the market. For example, fall armyworm damage can be suppressed using 

the Bt-expressing variety Herculex, but other Bt varieties such as YieldGard and 

KnockoutlNatureGard have less activity. However, when armyworm infestations are 

high all three varieties may require supplemental insecticidal treatment (Bessin 2004). 

The proposed MIR162 variety (including varieties stacked to include the trait) would 

provide growers an alternative to these GE insect resistant com lines if fall armyworm 

damage is expected to be high. 

Similar to the no action alternative, com will continue to be produced in 49 states 

(USDA-NASS 2008) and the range of com production wi11likely be unchanged as a 

result of APHIS' deregulating MIR162 com. MIR162 com does not enhance any other 

agronomic traits, besides insect resistance. Insects targeted by MIR 162 are commonly 

found in areas currently under com cultivation (University of Illinois Extension, 2004; 

Penn State University, 2010) and the pest insects that MIR162 controls are not a limiting 

factor that prevents com from being produced in any specific US location. Therefore, 

control ofthe susceptible pest insects will not open any new areas to com cultivation. 

Syngenta has field tested MIR162 com since 1999 under permits issued or notifications 

acknowledged by APHIS across 20 representative com growing areas (pg. 127 in 

Syngenta 2007). The majority of agronomic data were collected during the 2005 and 

2006 growing seasons across 6-10 locations representative of the major com-growing 

areas of the upper mid-west U.S. Except for test weight, grain moisture at maturity and 

plant emergence, the traits ofMIR162-derived hybrids were not statistically significant 

compared with their control (non-GE) counterparts (Tables 22 & 23, pg. 65-66 in 

Syngenta 2007). APHIS also assessed whether the MIR162 com is any more likely to 

become a weed than the isogenic nontransgenic com line, or other com varieties currently 

under cultivation (USDA-APHIS 2009). APHIS thoroughly considered the basic biology 

of com and evaluated the unique characteristics ofthe MIR162 com under field 

conditions (USDA-APHIS 2009). Based on the agronomic field data and a literature 

17 
survey of com's weediness potential, APHIS concluded that MIR162 com lacks ability to 

persist as a troublesome weed (USDA-APHIS 2009). 

The main introduced trait in MIR162 is expected to provide pest resistance to certain 

insects. Therefore, except for change in insect pest management practices, all other 

agricultural practices for MIR162 com, including conventional com weed control 

practices and herbicide use, are not expected to be different from those for conventional 

com cultivation. These impacts, including the use ofEP A registered herbicides would be 

similar to the no action alternative. The use ofMIR162 com should reduce human and 

environmental exposure to insecticides used for insect pest control in other, existing com 

varieties. 

B-3. Potential Impacts ofLine MIRJ62 Corn on Insect Control Practices 

Under this alternative, in addition to MIR162 com, insect control options including the 

use of conventional insecticide applications, microbial insecticide applications, crop 

rotation, and planting ofGE insect resistant cultivars will remain available to com 

growers. Before the introduction ofGE com varieties, com growers had difficulty 

controlling European com borer, which caused up to $1 billion of annual economic loss 

in the U.S. including costs ofpesticide treatment and lost yield (Martin and Hyde, 2001). 

The introduction ofthe first GE Bt com hybrids in 1996 provided growers with an 

effective means oflimiting damage caused by European com borer. GE Bt com use 

(both Bt only and stacked) grew from zero percent of com acreage in 1996 to 63 percent 

in 2009 (USDA-ERS 2009). These GE com hybrids express either a cryJAh or cryJF 

gene from B. thuringiensis, which encode proteins that are highly toxic to European com 

borer and cry3BhJ or cry34AhJ, and cry35AhJ that are toxic to com rootworm. Based on 

the effectiveness of currently available GE Bt com varieties (Marvier et al. 2007), it is 

reasonable to assume that farmers using MIR162 will observe similar positive benefits. 

Controlling above-ground insects presents a challenge for com growers, as many pests 

are shielded from aerial chemical applications or treatment may not be economically 

feasible. As a result, the majority of com fields are not treated with pesticides for leaf-, 

stalk-, and ear-feeding insects. MIR162 com has the potential to control above-ground 

insect pests including com earworm, black cutworm, western bean cutworm, and fall 

armyworm that are not controlled by some Bt com varieties expressing Cry proteins. 

Doane Marketing Research AgroTrak studies (Doane Marketing Research 2006) indicate 

that growers in 2005 and 2006 were treating approximately three million acres a year 

with conventional insecticides for control ofthese insects with an estimated grower cost 

of20 to 23 million dollars (Table 32, pg. 94 in petition). Compared to the total number 

of com acres planted annually in the U.S. (86 million acres in 2008), this represents a 

relatively small use of conventional pesticides «3.5% ofthe total com acreage). 

In addition to direct damage caused by feeding on plant tissue, insects play an important 

role in the transmission and dissemination of pathogenic organisms during com 

development. Feeding by Diabrotica rootworms has been associated with increased 

frequencies ofFusarium fungal infection (Dicke and Guthrie 1988), and rootworm 

18 
feeding may also lead to increased incidences of stalk rots. Likewise, com earworm 

feeding is associated with Fusarium infestation (Smeltzer, 1949). Ear, kernel, and cob 

rots occur wherever com is grown and result in reduced test weight, poor grain quality, 

and mycotoxin contamination of food and feed. Fusarium kernel or ear rot is the most 

widespread disease of com ears and is frequently associated with insect feeding damage. 

These pathogenic infections can lead to reduced crop quality, ability to harvest, and yield. 

Mycotoxin contamination of com grain presents a potential threat to livestock health and 

it has been found worldwide in animal feed (Placinta et ai. 1999; Monbaliu et ai. 2010). 

Since some current Bt varieties with partial resistance to com earworm are partially 

successful in reducing fumonisin content (Clements et aI., 2003), the availability of 

MIR162 will provide farmers with an additional management option that will likely help 

farmers increase their capacity to alleviate adverse affects of mycotoxins on crops and 

animals. 

Under this alternative, EPA approved insecticides will remain available for use based on 

the need and effectiveness against different insect species infesting commercial 

cornfields. However, growers may have only a narrow time window during which 

insecticides can be applied to com crops. For example, optimal insecticidal application 

for com earworm infestation is the period of 1-3 days during 90-100% silking stage 

(Burkness et ai. 2009). After earworms enter into enclosed parts ofthe com ear, 

earworms are shielded from contact with the insecticides rendering them ineffective. 

MIR162 com provides excellent protection against feeding damage caused by com 

earworm, black cutworm, western bean cutworm, and fall armyworm without the 

application limitations associated with the use of insecticides. For this reason, the 

introduction ofMIR162 com will have a positive impact on current com insect control 

practices. This product has the potential to displace many conventional insecticide 

applications on com (see pg. 92-96 in Sygenta 2007) resulting in a reduction in the 

number ofpounds ofinsecticides that may be used to protect com from insect damage. 

B-4. Organic and Other Non-transgenic Corn Production 

The National Organic Program (NOP) is administered by USDA's Agricultural 

Marketing Service (AMS). Organic farming operations as described by the National 

Organic Program 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. Organic production operations 

must also develop and maintain an organic production system plan approved by their 

accredited certifying agent. This plan enables the production operation to achieve and 

document compliance with the National Organic Standards, including the prohibition on 

the use of excluded methods. Excluded methods include a variety ofmethods used to 

genetically modify organisms or influence their growth and development by means that 

are not possible under natural conditions or processes. 

Organic certification involves oversight by an accredited certifying agent of the materials 

and practices used to produce or handle an organic agricultural product. This oversight 

includes an annual review ofthe certified operation's organic system plan and on-site 

19 
inspections of the certified operation and its records. Although the National Organic 

Standards prohibit the use of excluded methods, they do not require testing of inputs or 

products for the presence of excluded methods. The presence of a detectable residue of a 

product of excluded methods alone does not necessarily constitute a violation ofthe 

National Organic Standards (USDA-AMS 2007). The unintentional presence of the 

products of excluded methods will not affect the status of an organic product or operation 

when the operation has not used excluded methods and has taken reasonable steps (such 

as isolation zones, use of buffer rows surrounding the organic crops or adjusting planting 

dates and appropriate cleaning of planting and harvesting equipment) to avoid contact 

with the products of excluded methods as detailed in their approved organic system plan. 

Organic certification of a production or handling operation is a process claim, not a 

product claim. 

It is not likely that organic farmers, or other farmers who choose not to plant transgenic 

varieties or sell transgenic grain will be significantly impacted by the commercial use of 

MIR162 com. Nontransgenic com will likely still be sold and will be readily available to 

those who wish to plant it. Despite the introduction and adoption oftransgenic com 

cultivars over the past decade, including multiple varieties ofBt com, non-GE specialty 

and organic com remain readily available. In 2006, there were at least 18 seed 

companies in the U.S. specializing in organic com seed (see pg. 110-111 in Syngenta 

2007). 

Organic and other farmers have expressed concern that the widespread planting ofBt 

com plants will hasten the development ofpest resistance to pesticidal Bt endotoxins. 

Farmers purchasing seed will know this product is transgenic because it will be marketed 

as Vip3aA20 lepidopteran resistant; and based on the EPA insect resistance management 

(IRM)2 policy (BPPD-EPA 2001), farmers will be educated by the Syngenta's 

stewardship plan about recommended management practices on MIR162 com cultivation. 

Transgenic com lines resistant to lepidopteran insects, and/or tolerant to specific 

herbicides are already in widespread use by farmers. This particular product should not 

present new and different issues than existing insect resistant Bt com cultivars with 

respect to impacts on organic farmers. 

APHIS recognizes that com is open-pollinating and it is possible that the engineered 

genes could move via wind-blown pollen to an adjacent field. All com, whether 

genetically engineered or not, can transmit pollen to nearby cornfields. However, an 

influx of pollen originating from a given com variety may not appreciably change the 

characteristics of com in adjacent fields because gene flow declines as a power of 1I~ 

and other factors such as wind speed, host variety and temperature also affect the results 

(Aylor et aI., 2003; Jones and Brooks, 1950). For example, assessing observations of a 

large number of commercial canola fields, incidence oftransgene flow was on the order 

2 Insect resistance management (IRM) is the term used to describe practices aimed at reducing the potential 

for insect pests to become resistant to a pesticide. Specific IRM strategies, such as the high dose/structured 

refuge strategy, developed by EPA are expected to mitigate insect resistance to specific Bt proteins 

produced in corn 

20 
of 0.015 % at 500m (see Fig 2 in Rieger, 2002) and in a smaller com study, 0.05% at 

100m (Goggia et aI., 2006). 

Methods ofspatial and temporal isolation are widely used and accepted when seed 

producers are seeking to minimize the influx ofpollen from sources outside the seed 

production field. To maintain varietal purity, the AOSCA (Association of Official Seed 

Certifying Agencies) recommends 200 meters isolation for nearby com populations to 

produce foundation class of certified seed (AOSCA 2003). These methods are readily 

applicable to the production of certified organic com seed. Gene flow rate between com 

populations is extremely variable depending on the spatial, temporal, genetic and 

environmental factors (Brookes and Barfoot et al. 2004; Messegue et ai. 2006). Yet, 

available experimental evidence indicates that gene flow rates drop substantially (1 %) 

beyond 20 meters (Henry et al. 2003; Ma et al. 2004; Messeguer et al. 2006). 

Data provided in the petition from agronomic trials conducted in 2005 and 2006 in a 

variety oflocations in the U.S. demonstrated that the MIR162 com is not significantly 

different in yield from its nontransgenic counterpart (Tables 22 and 23, pg. 65-66 in 

Syngenta 2007), and the MIR162 com hybrids were not significantly different from 

control lines (non-GE) in terms of pollen viability, morphology, and diameter (Table 24, 

pg. 67 in Syngenta 2007). Therefore, MIR162 com hybrids are not expected to have an 

increased ability to cross-pollinate other com varieties when compared to conventional 

varieties that are currently available for commercial planting. 

If Syngenta receives regulatory approval from all appropriate agencies, it will likely 

make MIR 162 com available to growers and breeders. It is not likely that other farmers 

who choose not to plant or sell MIR162 com,such as organic producers, or that other 

transgenic com varieties will be significantly impacted by the expected commercial use 

ofthis product as (a) non-transgenic com varieties will likely still be sold and will be 

readily available to those who wish to plant them; (b) Syngenta's stewardship plan will 

provide farmers that purchase MIR 162 com recommended management practices for 

MIR162 com cultivation; (c) methods of spatial and temporal isolation are widely used 

and accepted and com seed producers employing them can minimize the influx of pollen 

from sources outside the seed production field; (d) 85% ofthe 2008 com acreage in the 

United States is already planted to transgenic herbicide tolerant and/or insect resistant 

varieties; and (e) APHIS expects that MIR162 may replace some ofthe presently 

available GE com varieties without significantly affecting the overall total com acreage. 

APHIS concludes that organic farmers will be able to coexist with biotech com producers 

as they do now. 

B-5. Potential Impact on Non-target Organisms, Including Beneficial Organisms and 

Threatened or Endangered Species 

APHIS evaluated the potential for MIR 162 com plants and their products to have 

damaging or toxic effects directly or indirectly on non-target organisms (USDA-APHIS 

2009). Non-target organisms considered were those representative ofthe agricultural 

environment, including those that are recognized as beneficial to agriculture (Table 31, 

21 
pg. 89 in Syngenta 2007) or as threatened or endangered in the U.S. APHIS also 

considered potential impacts on other "non-target" pests, since such impacts could 

potentially change agricultural practices. The technical details ofthe experiment on nontarget organisms have been described in the Plant Pest Risk Assessment ofMIR162 com 

(USDA-APHIS 2009; see also pg. 85-88 in petition for details). 

Different types (variants) of Vip proteins occur in nature, and three variants ofVip 

protein (Vip3Aal, Vip3Aal9, Vip3Aa20) are used for the nontarget impact 

investigations. The three protein variants (Vip3Aal, Vip3Aal9, Vip3Aa20) differ from 

each other by 1-2 amino acids (Table 12, pg. 48 in Syngenta 2007), and all three are 

found be biochemically and functionally equivalent (see Table 13 and explanation thereof 

on pg. 50 in Syngenta 2007). The Vip3Aal9 variant is present in Syngenta's deregulated 

cotton event COT 102. Likewise, the Vip3Aa19 variant was also present in com cultivar 

Pacha maize. Syngenta discontinued Pacha maize due to agronomic performance reasons 

and replaced its commercial development by MIR162 maize. Therefore each one of the 

nontarget exposure investigation, detailed in the following paragraphs, was carried out 

using one ofthe three Vip variant proteins (Table 30, pg. 84 in Syngenta 2007). 

Potential impacts ofVip3Aa on higher animals. In the bird (bobwhite quail, Colinus 

virginian us ), mammal (mouse, Mus musculus), and honey bee (Apis mellifera) study 

conducted by Syngenta, there were no observable adverse effects or differences in 

survival noted at doses ofVip3A proteins that were well above those expected from 

exposure to the Vip3Aa20 protein from the MIR162 com planted in the field (Table 31, 

pg. 89 in Syngenta 2007 ). 

Potential impacts ofVip3Aa on above-ground arthropods. Adult pink spotted ladybird 

beetle (Coleomegilla maculata), seven-spot ladybird beetle (Coccinella septempunctata), 

second-instar minute pirate bug (Orius insidiosus), adult green lacewings (Chrysoperla 

carnea), and two- to three-day old C. carnea larvae were exposed to Vip3Aal9 protein. 

The difference in survival of the beetles in the treatment and control groups was not 

statistically significant (see pg. 86 in Syngenta 2007). 

Although not an endangered or threatened species, Danaus plexippus (monarch butterfly) 

is a species of high conservation interest, and there has been concern that it may be 

harmed by consuming pollen from transgenic insect-protected com. Studies of a similar 

Bt protein, Cry lAb, have shown that exposure of Monarch butterfly larvae to this protein 

in the vicinity of com fields is not high enough to cause mortality (Anderson et aL 2004). 

However, Vip3A has no toxicity to monarch butterflies (Lee et al. 2003). APHIS 

concludes that because of apparent tolerance to the toxin (D. plexippus) and limited 

actual exposure, the larval monarch butterflies are not likely to be impacted by the 

cultivation of this Vip3Aa20-expressing crop. Effects ofa Vip3A X CrylAb Bt com 

variety on non target arthropods were assessed by Dively (2005) and compared to an 

isogenic control line. Populations of most insect taxa in both varieties were not 

significantly different, although some increases or decreases were caused by prey density 

responses, the absence of plant injury or some plant based factor, rather than toxicity of 

the host plant. 

22 
Potential impacts on threatened and endangered arthropods. With respect to the 

Endangered Species Act and oversight by the U.S. Fish and Wildlife Service (FWS), 

APHIS has established an agreement with FWS specifying how APHIS should review 

data provided by applicants. The process includes a framework to detennine if a FWS 

consultation may be required under section 7 ofthe Endangered Species Act, before 

APHIS may grant non regulated status to products such as MIR162 corn. APHIS has 

obtained and reviewed the list offederally listed threatened and endangered species, 

species proposed for listing, and designated critical habitat or habitat proposed for 

designation as part ofthe review process. Based upon this review and adherence to the 

established process identified in the FWS agreement, APHIS has concluded that a 

consultation with FWS was not necessary for MIR162 corn. 

Given the narrow specificity ofthe Vip3Aa20 activity, species outside the insect order 

Lepidoptera are not expected to be affected by Vip3Aa20 protein toxicity. Its receptormediated mechanism of action and absence of activity in bioassays with multiple species 

outside ofthe order Lepidoptera, as discussed in preceeding paragraphs, support this 

conclusion. Furthennore, Syngenta observed no hannful effects ofVip3Aa proteins in 

nontarget organism hazard identification studies that used a wide range of taxa at 

expected environmental concentrations. The test results indicated a lack of risk associated 

with exposure to Vip3Aa20 in the MIR162 corn (Table 31, pg. 89-90 in Syngenta 2007). 

The Vip3Aa20 protein is selectively toxic to a few species of insect pests belonging to 

the order Lepidoptera. The only threatened or endangered lepidopteran species with 

potential for exposure to insecticidal proteins in corn is the Karner blue butterfly 

(Lycaeides melissa samuelis) (EPA 2001; USFWS 2007). The Karner blue butterfly 

requires wild lupine (Lupinus perennis) as an oviposition substrate and larval food 

source, while the adults feed on wild flowers. The potential route of exposure is 

consumption ofmaize pollen that has settled on the leaves of its food plant, the wild 

lupine (Lupinus perennis). Karner blue butterfly is known to exist along the northern 

extent ofthe range ofwild lupine, where there are prolonged periods ofwinter snowpack, 

in parts of Wisconsin, Michigan, Minnesota, Indiana, New Hampshire, New York, and 

Illinois (Haack 1993). Although there are two counties in Wisconsin that have been 

identified as having a potential overlap between corn pollen shed and the presence of 

Karner blue larvae (peterson et al. 2006 ), there is no evidence ofKarner blue butterfly 

exposure to corn pollen in these locations. According to Peterson et al. (2006) the 

exposure ofthe Karner blue butterfly to maize pollen was minimal in all other locations 

because most lupine popUlations are separated from maize fields by at least 500 metres, 

and because maize anthesis (flowering) usually occurs after the Karner blue larvae have 

finished feeding. 

APHIS coordinates review ofpetitions with other agencies that have regulatory oversight 

for these same products. With respect to threatened and endangered species, EPA also 

plays a specific role in the evaluation ofGE insecticide resistant crops, including MIR162 

corn. The Endangered Species Protection Program (ESPP) of EP A places geographically 

specific use limitations on pesticides in order to protect threatened and endangered 

23 
species from pesticides (EPA 2009). Any use restrictions are identified on the EPA 

approved label associated with a specific EPA-registered product. 

The EPA on August 6, 2008 approved a tolerance for Vip3Aa20 in com or cotton, and on 

February 13,2009 conditionally approved the use ofVip3Aa20 for use with two other Bt 

proteins (EPA 2009a, 2009b). In these assessments, EPA stated that the agency was not 

aware of any adverse effects ofVip3Aa proteins on the abundance ofnon-target 

beneficial systems in any population in a field environment, inclusive of pest parasites, 

pest predators or pollinators. EPA also concluded that the hybrid will produce no 

unreasonable harm to the environment or any federally listed threatened and endangered 

species. Although refuges were required for commercial use ofthe Vip3Aa protein, EPA 

did not specify any other geographic limits for use in production agriculture. EPA also 

concluded that the use of the pesticidal protein contained in MIR162 corn will not cause 

any unreasonable adverse effects on the environment during the time of conditional 

registration (EPA 2009a,b). APHIS concurs with the EPA assessment (EPA 2009) that 

the protein produced by this variety will have no adverse effects in the environment. 

As previously discussed, APHIS concludes that MIRI62 will not adversely impact 

arthropods which may be exposed to the host plant. APHIS concludes that for other 

endangered or threatened animals or plant species in the U.S., MIRI62 com is not 

expected to have any harmful effects because toxicity ofVip3Aa20 is restricted to 

Lepidoptera. Based upon the information available in the literature, on the EPA 

assessment and on the data supplied by Syngenta, APHIS determined that the unconfined 

release following deregulation of MIRI62 com would have no effect on federally listed 

threatened and endangered species, species proposed for listing, or on designated critical 

habitat or habitat proposed for designation (USDA-APHIS 2009). 

Environmental fate in soil and effects on soil dwelling organisms. The purpose of a 

Syngenta (2007) soil fate study was to test the inherent degradability of Vip3Aa20 in a 

soil typical of com-growing areas with healthy microbial activity. Most proteins do not 

persist or accumulate in soil because they are inherently degradable in soils (Bums 1982; 

Marx et al. 2005). Multiple investigations have demonstrated that Bt Cry proteins are 

rapidly degraded in a variety of soil types and that the proteins do not accumulate (EPA 

2001; Head et al. 2002; Dubelman et al. 2005). Vip proteins are similar to Cry proteins 

in that they are also found in naturally occurring soil bacteria and commercial microbial 

insecticides (de Maagd et at. 2001). Under the activity of soil proteases, the Vip3Aa 

protein would be expected to be susceptible to degradation, unless specifically protected 

from such enzymatic hydrolysis (Marx et at 2005) 

Syngenta (2007) conducted a laboratory study to determine the degradability of 

Vip3Aal9 protein (Vip3Aal9 and Vip3Aa20 are functionally equivalent, see earlier text) 

in five soils (clay, sandy clay, loam, sandy loam, silt loam). A rapid decline in the levels 

ofVip3Aa19 was observed in all soil types, wherein degradation was measured as loss of 

insecticidal activity. The time to 50% dissipation (DT50) was estimated to be between 6.0 

and 12.6 days across soil types and test concentrations. The results ofthis study showed 

that Vip3Aa protein is rapidly degradable in normal soils. Thus, the Syngenta soil study 

data (Syngenta 2007) indicate that that there will not be a significant environmental 

24 
impact on the soil environment by granting nonregulated status to MIR162 due to limited 

persistence ofVip3Aa20 in the soil. 

Residual com plant debris is oftentimes incorporated into the soil after harvest, and 

Syngenta (2007) assessed impacts ofthe MIR162 com or its Vip3Aa protein on 

representative soil dwelling organisms. Data on the effects ofVip3Aa protein on 

earthworms, Eisenia foetida; a collembolan, Folsomia candida; and rove beetles, 

Aleochara bilineat were analyzed (see p. 87 in Syngenta 2007). These were variously 

incorporated as isolated protein or lyophilized leaf material as appropriate. Toxicity 

exposure ratios for these organisms was >9, > 114 and>1316, respectively, and indicate a 

lack ofrisk for soil organisms (Syngenta 2007). 

B-6. Cumulative Effects 

APHIS considered whether the proposed action could lead to significant cumulative 

impacts, when considered in light of other past, present, and reasonably foreseeable 

future actions, regardless ofwhat agency or person initiated such actions. APHIS has 

evaluated the potential cumulative impacts of granting nonregulated status to MIR162 

com. As discussed in the following paragraphs, both petitioner's data and USDA-APHIS 

review do not indicate any cumulative impact on the environment as a result ofAPHIS 

deregulation ofMIR 162 com (see pg. 104-108 in Syngenta 2007). 

Corn Production 

GE insect resistant com acreage has been steadily increasing from 0% to 63% over the 

last 13 years in the US (USDA-ERS 2009). MIR162 is not the first Bt com product to be 

granted nonregulated status. APHIS has previously made determinations ofnonregulated 

status for several other Bt com cultivars including petition numbers: 

94-319-01 p at http://www .aphis. usda. gov Ibrs/ aphisdocs2/94 _31901 P _corn. pdf; 

95-093-01p at http://www.aphis.usda.govlbrs/aphisdocs2/95 _09301 p_com.pdf; 

95-195-01p at http://www.aphis.usda.govlbrs/aphisdocs2/95_19501p_com.pdf; 

96-291-0Ip at http://www.aphis.usda.govlbrs/aphisdocs2/96_2910Ip_com.pdf; 

97-013-01p at http://www.aphis.usda.govlbrs/aphisdocs2/97 _0130Ip_com.pdf; 

97-265-01p at http://www.aphis.usda.govlbrs/aphisdocs2/97 _2650 1 p_com.pdf; 

00-136-Olp at http://www.aphis.usda.govlbrs/aphisdocs2/00_13601p_com.pd; 

01-137-0Ip at http://www.aphis.usda.govlbrs/aphisdocs2/0l_13701p_com.pdf; 

03-l81-0Ip at http://www.aphis.usda.govlbrs/aphisdocs2/03_181Olp_com.pdf; 

04-125-Olp at http://www.aphis.usda.govlbrs/aphisdocs2/04_12501p_com.pdf; 

04-362-01p at http://www.aphis.usda.govlbrs/aphisdocs2/04_36201p_com.pdf; 

06-298-01p at http://www.aphis.usda.govlbrs/aphisdocs2/06_29801p_com.pdf; 

According to Syngenta, the combined-trait Bt11xMIR162 hybrids are efficacious against 

five major insect pests (European com borer, com earworm, fall armyworm, black 

cutworm, western bean cutworm) and such hybrids have the potential to provide growers 

the means ofprotecting their com crops from damage caused by a broader range of 

lepidopteran pests (USDA-APHIS 2009). Based upon the increasing trend in GE insect 

resistant com acreage and the number ofGE insect resistant com varieties that are 

25 
commercially available to growers, it is reasonable to assume that the commercial 

availability, acceptance and use ofGE insect resistant com crops will continue into the 

foreseeable future with or without APHIS deregulation ofMIRl62 com. Com will 

continue to be produced in 49 US states (USDA-NASS 2009) and the range of com 

production will likely be unchanged as a result ofAPHIS deregulating MIR162 com. 

Non-transgenic com, including organic varieties will likely still be sold and will be 

readily available to those who wish to plant it. Despite the introduction and adoption of 

transgenic com cultivars over the past decade, including multiple varieties ofBt com, 

non-GE specialty and organic com remain readily available. 

Genetic purity ofcorn germplasm. APHIS does not foresee a cumulative impact on the 

genetic purity and diversity ofnon-GE com cultivars and germplasm from granting 

nonregulated status to MIR162 com (see pg. lOS in Syngenta 2007). Genetic purity and 

diversity has been a feature of com improvement cultivation for decades as part of hybrid 

seed and specialty com production. Many agricultural practices are effectively used by 

certified seed producers to grow and produce quality hybrid seed, including maintaining 

isolation distances to prevent pollen movement from other com; planting border or 

barrier rows to intercept pollen; employing natural barriers to pollen movement such as 

treelines, manual or mechanical detasseling; genetic male sterility; and staggered planting 

dates (see for example, Bradford 2006; MRSC 2009). These widespread management 

practices remain in use today and have served to ensure that the broad adoption of 

transgenic com in the U.S. (including the sale and cultivation ofmultiple Bt com 

varieties over more than a decade) has had no significant impact, even in the aggregate, 

on the production of com seed and specialty com products. APHIS expects that certified 

growers ofMIR162 and future hybrid com seed producers will continue to follow similar 

types ofmanagement practices to maintain genetic purity and diversity of com 

germplasm (see discussion in Syngenta, 2007 at IX C.7, Potential cumulative impacts.) 

In general, all management practices used in conventional hybrid seed production to 

ensure quality standards are also used for the production ofspecialty and organic com 

seed and typically are sufficient to meet assigned standards (see for example, USDAAMS 201 Oa). In addition, certifiers of organic standards assess farm plans and 

production methods, and make inspections to determine whether grower-proposed 

methods for organically produced crops are accomplished and standards are maintained. 

Genetic diversity ofcorn. APHIS does not foresee significant cumulative impacts on the 

genetic diversity or on the availability of diverse com germplasm resources because of 

the adoption ofmultiple varieties oftransgenic com. 

It is common practice in com seed production systems (GE and non-GE) to develop 

genetically distinct com hybrids for various geographies and purposes, and to continually 

improve these varieties through established plant breeding practices and techniques. A 

variety of GE and non-GE com cultivars have been and wi11likely continue to remain 

available to those who wish to plant them. Despite the introduction and adoption of 

transgenic com cultivars over the past decade, including multiple varieties ofBt com, a 

variety of non-GE com including specialty and organic varieties remain readily available. 

26 
In 2006, there were at least 18 seed companies in the U.S. specializing in organic com 

seed (see pg. 110-111 in Syngenta 2007). 

In addition, the adoption ofgenetically engineered com was preceded by a worldwide 

effort to identify and preserve sources of com genetic diversity, and to make these 

resources available for utilization by public and private com breeders. Among these 

efforts are the Germplasm Enhancement ofMaize program ("GEM"), a cooperative effort 

undertaken by USDA, public and private plant sector breeders, NGOs (Non 

Governmental Organizations) and international public cooperators. GEM was 

established to further identify com genetic diversity and to provide it in useful form in 

order to broaden the genetic base of this crop. 

Multiple Bt corn events and insect resistance developing in the field. APHIS does not 

foresee significant cumulative impacts resulting from multiple Bt com events and insect 

resistance developing in the field. 

MIR162 com provides no protection against feeding damage caused by European com 

borer. Syngenta has indicated that they intend to commercialize MIR162 com as a 

combined-trait hybrid with Syngenta's Btl 1 com event (an APHIS deregulated GE insect 

resistant com variety that contains CrylAb Bt protein targeting European com borer) to 

control a variety oflepidopteran insect pests, such as European com borer, com earworm, 

black cutworm, western bean cutworm, and fall armyworm. According to Syngenta, the 

combined-trait hybrid (Bt1lxMIRI62) has a unique benefit. In this case, the combinedtrait containing CrylAb and Vip3Aa20 proteins have been demonstrated to provide highdose control ofEuropean com borer, com earworm, and fall armyworm. Because the 

type of toxicity of Vip proteins to insects seems to differ from those of Cry proteins (Lee 

et aI, 2003), a strategy of combining such toxins would be effective in reducing risk of 

cross- resistance developing in lepidopterous pests that are affected by both (Tabashnik et 

aI. 2009). Sygenta also intends to commercialize MIR162 as a combined traits hybrid 

with Btl 1 and MIR604, and increase its targeted insects to include com rootworm control 

(EPA 2009b) 

Syngenta has submitted an Insect Resistant Management (IRM) plan to the EPA for 

Bt1lxMIRI62 com that requires growers to plant a 20% structured refuge (see BBPDEPA 2001 for details) that can be planted as strips within or surrounding the Bt com field 

or as a block within, adjacent to, or up to 0.5 mile away. The proposed refuge 

requirements are the same in the Com Belt and cotton growing areas (see BBPD-EPA 

2001 for details). Use of these refuge strategies by growers have been shown to either 

delay or prevent the development of certain lepidopteran insect pest developing 

resistance to Bt (Bates et al. 2005). Although confirmed evidence of insect resistance to 

Bt com has developed in the field in Puerto Rico (Spodopterajrugiperda to Cry IF), and 

in South Africa (Buseola jusca to CrylAB) and to Bt cultivars of cotton in the Southeast 

US, most pest populations remain susceptible to Bts (Tabashnik et al. 2009). Crossresistance is possible, as between CrylAc and Cry2Ab in one cotton pest, and should be 

considered in assessing effectiveness of future strategies to avert development of 

resistance to Bt crops (Tabashnik et al. 2009a). 

27 
Potential impacts on threatened and endangered species. APHIS does not foresee 

significant cumulative impacts on threatened and endangered species resulting from 

APHIS deregulating MIR162 com. The restriction oftoxicity ofVip3Aa20 to 

Lepidoptera, and the minimal exposure of engendered Lepidoptera to com, indicates that 

planting ofthe MIR162 com is expected to have no harmful effects on any endangered or 

threatened species in the U.S (see lack of effects on wide range oftest organisms in 

Syngenta 2007). 

Potential impacts on biodiversity. APHIS has determined that there are no past, present, 

or reasonably foreseeable actions that would aggregate with effects ofthe proposed 

action to create cumulative impacts or reduce the long-term productivity or sustainability 

of any ofthe resources associated with the ecosystem in which the MIR162 com is 

planted. 

The importance of com as a food crop, and its dependence on human management, has 

produced a long history ofdiligence to protect germplasm lines of com (see Genetic 

purity of com germplasm section above). Decades prior to the introduction oftransgenic 

com products, the com industry developed effective methods and means to maintain 

product segmentation and genetic purity standards. Specialty corns, for example, were 

successfully isolated for years and continue to be grown today, even with transgenic com 

widely adopted in the U.S. Moreover, with respect to both conventional and transgenic 

com, the ability to protect and maintain the genetic purity ofbreeding lines is critical to 

seed companies and developers of new varieties such as MIR162. Consequently, seed 

companies routinely apply standard breeding techniques including physical and temporal 

isolation that have proven effective at maintaining the genetic purity of breeding lines. 

Genetically engineered corn lines with Bt traits (both Cry and Vip proteins) have been 

available on the market since 1994 and the body of evidence in peer-reviewed literature 

does not suggest any negative effect on biodiversity. APHIS review and analysis of 

Syngenta's data (USDA-APHIS 2009) indicate that the line MIR162 com exhibits no 

traits that would cause increased weediness, that its unconfined cultivation should not 

lead to increased weediness of other cultivated corn or other sexually compatible 

relatives. Consequently, MIR162 is not likely to harm non-target organisms common to 

the agricultural ecosystem or threatened or endangered species recognized by the U.S. 

Fish and Wildlife Service. 

B-7. Socioeconomic Analysis 

The main body ofinformation on socioeconomic analysis described in the following 

paragraphs comes from Syngenta's socioeconomic analysis (see pg. 108-112 and 

Appendix 1 in Syngenta 2007); the Environmental Protection Agency's (EPA) 

Biopesticide Registration Action Document, Vip3Aa20 com (EPA 2009c); USDAEconomic Research Service' (USDA-ERS) report, "The First Decade of Genetically 

Engineered Crops in the United States" (Fernandez-Cornejo and Caswell 2006); and 

BioTech InfoNet Technical Paper, "Genetically Engineered Crops and Pesticide Use in 

28 
the United States" (Benbrook 2004). APHIS assessment on the petitioner's 

socioeconomic analysis is restricted to the MIR 162 com and its stacked hybrids with 

other Bt traits (BtllxMIRI62, BtllxMIR162xMIR604). 

Agricultural Benefits. The increased adoption ofBt com cultivars since its introduction 

in the mid 1990s (USDA-ERS 2009) could imply that insect resistance varieties provide 

benefits to com farmers. This is more evident since the early 2000's when the Bt com 

varieties that are effective against European corn borer were complemented with a second 

generation Bt com cultivar that provide protection against com root worm. According to 

USDA's Agricultural and Resource Management Surveys (ARMS) conducted in 2001-03 

(see Figure 7 in Fernandez-Cornejo and Caswell 2006) most of the farmers adopting GE 

com, cotton, and soybeans indicated that they did so mainly to increase yields through 

improved pest controL Because the MIR162 com is effective against two major com 

insect pests, com earworm and western bean cutworm, which are not effectively 

controlled by earlier Bt com cultivars, it is reasonable to assume that likewise, potential 

benefits do exist for farmers adopting the MlR 162 com cultivars. Although it is difficult 

at this time to accurately predict the magnitude of economic benefits ofthe MIR162 com 

hybrids in the marketplace, because such hybrids are not currently in commercial 

production, the improved pest protection profile ofBt11xMIR162 com may translate into 

correspondingly higher overall economic benefits to growers, consumers, and other 

downstream users of com products. 

Syngenta has suggested that their stacked hybrids Btl 1 x MIR162 x MIR604 will provide 

unsurpassed control oftarget pests and that the product's "broad-lepidopteran control, 

particularly for com earworm and western bean cutworm, potentially results in better 

performance than those of competitors. However, EPA's Biopesticides and Pollution 

Prevention Division (BPPD) notes that these statements are unverified assumptions. 

Although the data support that the stack containing the Btl 1 , MIR162, and MIR604 traits 

produces reasonably good efficacy against western bean cutworm, the MIR604 trait when 

combined with the MIR162 trait showed some evidence of a possible synergistic effect in 

the control of com rootworm. BPPD reasons that the sample size used by Syngenta for 

the investigation is too small to delineate impacts of individual Bt traits in stacked 

hybrids. According to BPPD, Syngenta's specific economic benefits are based on bestcase assumptions (i.e., quick and broad adoption of the product in the marketplace). 

Competition from previously registered Bt com products (already established in the 

market) and grower familiarity with these products may reduce the overall adoption, and 

the potential benefits for MIR162 com and its associated products. Despite this 

shortcoming however, BPPD notes that both the stack and pyramid products, and the 

single-trait product appear to provide good protection against European com borer and 

com earworm. For many growers, the potential broad lepidopteran control expected by 

Bt11xMIR162 hybrids may provide added benefits than currently available Bt com 

cultivars, as com growers with multiple pest problems are expected to be protected from 

major com pests. 

So far, Bt hybrids have mixed responses when it comes to monetary benefits to com 

growers. In 2006, USDA-ERS published a rep011 on "The First Decade ofGenetically 

29 
Engineered Crops in the United States" focusing on GE crops and their adoption in the 

United States over the past 10 years (Fernandez-Cornejo and Caswell 2006). The 

economic analysis in that report mainly focused on the field data from 1997 and 1998 

(see Table 1). On average, BT technology benefitted com farmers with 5% higher yields 

in the United States, and yield effects were larger in years with high pest pressures as 

noted earlier by other investigators (Carpenter et al. 2002). Many field tests and farm 

surveys have also examined the yield and cost effects ofusing Bt com crops (Table 1). 

The majority of the results show Bt com crops produce higher yields than conventional 

crops. A more recent ERS study using 2001 survey data found that, on average, actual 

com yield was 12.5 bushels per acre higher for Bt com than for conventional com, an 

increase of9% (Fernandez-Cornejo and Li 2005). 

The economic benefits of growing Bt com do not appear to be consistent across growing 

seasons. There was a negative association between adoption ofBt com and producer net 

returns in 1998. According to Fernandez-Cornejo and Caswell (2006) this negative trend 

suggests that Bt com may have been used on some acreage where the value of protection 

against the European com borer was lower than the premium paid for the Bt seed. 

Because pest infestations vary from one region to another and from one year to another, 

the economic benefits ofBt com are likely to be greatest where pest pressures are most 

severe (Carpenter et al. 2002; Shelton et al. 2002). Farmers must decide to use Bt com 

before they know what the European com borer pest pressure will be that year. For that 

reason management practices are tailored accordingly (Mason et al. 1996). Because of 

this unpredictable variation, many farmers generally ignored European corn borer 

infestation and accepted the losses it caused (Shelton et al. 2002). 

According to Gurian-Sherman (2009) there was a 3-4 percent yield advantage for Bt com 

varieties in the U.S. for combining the benefits ofEuropean com borer and com root 

worm resistance. However, Gurian-Shel111an's analysis also showed that Bt corn yield 

benefits were not much different from what was achieved through traditional breeding. 

For example, com yield has been increasing on average 1 percent per year over the past 

several decades, and Bt com crops had the same yearly improvement in the last 14 years 

since the introduction of first Bt crop in 1996. Several approaches, such as organic 

cultivation, wheat-com rotation etc, other than current pesticide regimes and GE have the 

potential to reduce yield loss from com borer and rootworm in com. These approaches 

also have other associated benefits such as lower levels ofpesticide use, improved soil 

qualities, increased carbon sequestration, and improved water quality (but also see the 

comments on the report by Sheridan 2009). 

Adoption of GE crops is associated with reduced pesticide use. Insecticide use on fields 

planted to 8t com substantially decreased since its introduction in mid 1990s (Figure 1 

and Figure 8 in Fernandez-Cornejo and Caswe112006) and use rates on com (in tel111s of 

active ingredient) have declined since the introduction ofGE com in 1996. More 

recently, using 2001 data, USDA-ERS found that insecticide use was 8 percent lower per 

planted acre for adopters ofBt com than for nonadopters (Fernandez-Cornejo and Li 

2005). The USDA-ERS results generally agree with field-test and other farm surveys 

that have examined the effects of using GE crops (Table 1). 

30 
Table I. Summary ofprimary studies on the effects of genetically engineered Bt com on 

yields, pesticide use, and returns (Modified from Fernandez-Conejo and Caswe1l2006). 

Reference Data 

Source 

Effects on 

(NA = Not analyzed in the study) 

Yield Pesticide 

Use 

Returns 

Rice and Pilcher, 1998 Survey Increase Decrease Depends on 

infestation 

Marra et aI., 1998 Survey Increase Decrease Increase 

Benbrook, 2001 Survey Increase NA Decrease 

Me Bride & El-Osta, 2002 Survey 'NA NA Decrease 

Duffy, 2001 Survey Increase NA Same 

Pilcher et aI., 2002 Survey Increase Decrease NA 

Baute, Sears, and Schaafsma, 

2002 

Experiments Increase NA Depends on 

infestation 

Dillehay et aI., 2004 Experiments Increase NA NA 

Fernandez-Cornejo & Li, 

2005 

Survey Increase Decrease NA 

The MIRI62 com and stacked hybrids may further reduce the insecticide use ifthe 

current trend in insecticide usage continues (Figure 8 in Fernandez-Cornejo and Caswell 

2006). But according to Benbrook (2004) the insecticide reduction rate appears to have 

plateaued (Figure 1), and any further reduction in insecticide use from new Bt com 

cultivars may be marginal. For example, the amount ofinsecticide saved per acre ofBt 

com in 1996 was 0.16 pounds of active ingredient. As more acres ofBt com were 

planted, insecticide use was reduced on a smaller share of these Bt acres, leading to a 

lower average reduction in insecticide use across all acres planted to Bt com. In recent 

years, the reduction has been only 0.02 pounds per acre (see Figure 1 in Benbrook 2004). 

Besides the monetary benefits, Fernandez-Cornejo and Caswell (2006) noted that there 

are several other beneficial factors, such as ease of operation and time savings, which 

may have made GE crops attractive to farmers. Despite the mixed results on Bt benefits, 

from the com growers' perspective, as reflected in the increased rate of adoption ofBt 

corn cultivars ever since 1996, the farm profitability has gradually been increasing 

through higher yields and/or lower costs (e.g., operator labor, energy savings, pesticide 

purchases) by growing Bt com crops. 

31 
Olart 2. Trends in InsedicideApplications to Managethe Elropean Olm 


Borerand SoutI1v.esb!m Com Borer and the Reduction in Insed:idde l.l!ie onl 


BtOlmAaes 

1996 1997 1998 1999 2I.XlO 2001 2002 2003 2OCI4 

Years 

~ 0.25 

a:: 

Q/ 0.2 a::n 

til "0 

~ ~ 0.15 «Q.

"O~ 0.1 

.a'§, 0.05 

~ 0 

Figure 1. Reproduced from Benbrook 2004 "Chart 2. Trends in Insecticide Applications 

to Manage the European Com Borer and Southwestern Com Borer and the Reduction in 

Insecticide Use on Bt Com Acres". 

Another potential economic benefit for growers and downstream consumers is increased 

competition in the marketplace for pest-control products, including hybrid seed from 

multiple marketers oflepidopteran-tolerant Bt com varieties. The commercial 

availability ofMIR162 hybrid com seed may represent a important new pest control 

option and tool for growers. Increased grower choice may exert downward pressure on 

the cost ofproducts that offer control oflepidopteran pests (see pg. 110 in Syngenta 

2007). 

Human Health and Environmental Benefits. There is no human health concerns with 

respect to toxicity or allergenicity and no unreasonable environmental concerns with 

respect to toxicity ofthe insecticidal proteins expressed in the MIR162 com (Appendix I 

in this EA; 2001). Also, use ofBt com can decrease farm worker exposure to Bt 

sprays and chemical insecticides and reduce the mold infestation on com seeds 

(Carpenter et al. 2002). Consequently, any reduction in mold toxins resulting from use of 

Bt com can provide direct benefits to people and com-fed livestock. In a variety offield 

studies, other insect protected com expressing Bt proteins have been shown to have 

extensively lower levels of cornmon mycotoxins that are produced by fungal pathogens 

(Wu 2006); however, the mycotoxin levels in MIR 162 com in commercial cultivation is 

not available at this time. 

Insect Resistance Management Benefits. According to EPA the MIR162 com and its 

stacked Bt hybrids have the potential to delay development ofresistance in other com 

varieties expressing Cry toxins. The introduction ofMIR162 com and its stacks or 

32 
pyramids may have an additional benefit of prolonging the lifetime ofother com Plant 

Incorporated Protectants (PIP) technologies by providing another mode of action for 

European com borer, com earworm, fall armyworm, and com rootworm. 

Effects on the Export Market. Syngenta does not expect any effects on the United States 

com export market by the cultivation of the MIR162 cultivars since Syngenta is actively 

pursuing regulatory approvals for the MIR162 com in countries that import com from the 

United States or Canada. Regulatory filings for the MIR162 com are in process for 

Colombia, Japan, South Korea, Taiwan, China, the Philippines, Australia and New 

Zealand, South Africa, the European Union, Russia, and Switzerland. Syngenta's 

stewardship agreements with growers will include a term requiring growers to divert this 

product away from export markets (i.e. channeling) where the grain has not yet received 

regulatory approval for import. Syngenta will communicate these requirements to 

growers using a wide-ranging grower education campaign (e.g., grower Stewardship 

Guide (see pg. 111 in Syngenta 2007). 

C. Consideration ofExecutive Orders, Standards and Treaties Relating to 

Environmental Impacts 

Executive Order (EO) 12898, "Federal Actions to Address Environmental Justice in 

Minority Populations and Low-Income Populations," requires Federal agencies to 

conduct their programs, policies, and activities that substantially affect human health or 

the environment in a manner so as not to exclude persons and populations from 

participation in or benefiting from such programs. It also enforces existing statutes to 

prevent minority and low-income communities from being subjected to 

disproportionately high and adverse human health or environmental effects. 

EO 13045, "Protection of Children from Environmental Health Risks and Safety 

Risks," acknowledges that children may suffer disproportionately from environmental 

health and safety risks because of their developmental stage, greater metabolic activity 

levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by 

law and consistent with the agency's mission) requires each Federal agency to identify, 

assess, and address environmental health risks and safety risks that may 

disproportionately affect children. 

Each alternative was analyzed with respect to EO 12898 and 13045. Based on the 

information submitted by the applicant and assessed by APHIS, MIR162 com is not 

expected to have a disproportionate adverse effect on minorities, low-income 

populations, or children. MIR162 is not significantly different than conventional com 

and has successfully completed the FDA voluntary consultation for food and feed use. 

Collectively, the available mammalian toxicity, along with the history ofsafe use of 

microbial Bt products and other com varieties expressing Bt proteins, establishes the 

safety ofthe com line MIR162 and its products to humans, including minorities, low 

income populations, and children who might be exposed to them through agricultural 

production and/or processing. 

33 
None of the impacts on agricultural practices expected to be associated with deregulation 

of the com line MIR162 are expected to have a disproportionate adverse effect on 

minorities, low income populations, or children. As noted throughout the EA, the 

cultivation of previously deregulated com varieties with similar insect resistant traits has 

been associated with a decrease or shift in pesticide applications for those who adopt 

these varieties that is either favorable or neutral with respect to environmental and human 

toxicity. If pesticide applications are reduced, there may be a beneficial effect on 

children and low-income populations that might be exposed to the chemicals. These 

populations might include migrant farm workers and their families, and other rural 

dwelling individuals who are exposed to pesticides through ground-water contamination 

or other means of exposure. It is expected that EPA and USDA Economic Research 

Service would monitor the use ofthis product to determine impacts on agricultural 

practices such as chemical use as they have done previously for Bt products. 

EO 13112, "Invasive Species", states that Federal agencies take action to prevent the 

introduction ofinvasive species and provide for their control and to minimize the 

economic, ecological, and human health impacts that invasive species cause. Non-GE 

com as well as GE Bt and herbicide tolerant com varieties that have been granted 

nonregulated status are widely grown in the United States. Based on historical 

experience with these varieties and the data submitted by the applicant and assessed by 

APHIS, MIR162 com is sufficiently similar in fitness characteristics to other com 

varieties currently grown, and it is not expected to have an increased invasive potential 

(see USDA-APHIS 2009). 

INTERNATIONAL IMPLICATIONS 

EO 12114, "Environmental Effects Abroad of Major Federal Actions" requires 

Federal officials to take into consideration any potential environmental effects outside the 

U.S., its territories and possessions that result from actions being taken. APHIS has 

given this due consideration and does not expect a significant environmental impact 

outside the U.S. should nonregulated status be determined for the com line MIR162 or if 

the other alternatives are chosen. All the considerable, existing national and international 

regulatory authorities and phytosanitary regimes that currently apply to introductions of 

new com cultivars internationally, apply equally to those covered by an APHIS 

determination ofnonregulated status under 7 CFR part 340. Any MIR162 com in 

international commerce subsequent to a determination ofnon-regulated status for the line 

MIR162 would be fully subject to national phytosanitary requirements and be in 

accordance with phytosanitary standards developed under the International Plant 

Protection Convention (IPPC). 

The purpose ofthe IPPC "is to secure a common and effective action to prevent the 

spread and introduction of pests of plants and plant products and to promote appropriate 

measures for their control" (IPPC 2010)). The protection it affords extends to natural 

flora and plant products and includes both direct and indirect damage by pests, including 

weeds. The IPPC has set a standard for the reciprocal acceptance of phytosanitary 

certification among the nations that have signed or acceded to the Convention (173 

34 
countries as ofAugust 2009). In April, 2004, a standard for pest risk analysis of living 

modified organisms (LMOs) was adopted at a meeting ofthe governing body ofthe IPPC 

as a supplement to an existing standard, International Standard for Phytosanitary Measure 

No. 11 (ISPM-ll; Pest Risk Analysis for Quarantine Pests). The standard acknowledges 

that all LMOs will not present a pest risk, and that a determination needs to be made early 

in the PRA for importation as to whether the LMO poses a potential pest risk resulting 

from the genetic modification. APHIS pest risk assessment procedures for bioengineered 

organisms are consistent with the guidance developed under the IPpc. In addition, issues 

that may relate to commercialization and transboundary movement of particular 

agricultural commodities produced through biotechnology are being addressed in other 

international forums and through national regulations. 

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention 

on Biological Diversity (CBD) that established a framework for the safe transboundary 

movement, with respect to the environment and biodiversity, of LMOs, which includes 

those modified through biotechnology. The Protocol came into force on September 11, 

2003 and 156 countries are parties to it as ofJune 24,2009 (see CBD 2010). Although 

the U.S. is not a party to the CBD, and thus not a party to the Cartagena Protocol on 

Biosafety, U.S. exporters will still need to comply with domestic regulations that 

importing countries that are parties to the Protocol have put in place to comply with their 

obligations. The first intentional transboundary movement of LMOs intended for 

environmental release (field trials or commercial planting) will require consent from the 

importing country under an advanced informed agreement (AlA) provision, which 

includes a requirement for a risk assessment consistent with Annex III ofthe Protocol, 

and the required documentation. LMOs imported for food, feed or processing (FFP) are 

exempt from the AlA procedure, and are covered under Article 11 and Annex II ofthe 

Protocol. Under Article 11 Parties must post decisions to the Biosafety Clearinghouse 

database on domestic use ofLMOs for FFP that may be subject to transboundary 

movement. To facilitate compliance with obligations to this protocol, the US 

Government has developed a website that provides the status of all regulatory reviews 

completed for different uses ofbioengineered products (http://usbiotechreg.nbii.gov). 

These data will be available to the Biosafety Clearinghouse. 

APHIS continues to work toward harmonization ofbiosafety and biotechnology 

consensus documents, guidelines and regulations, including within the North American 

Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the 

U.S. and in the Organization for Economic Cooperation and Development (OECD). 

NAPPO has completed three modules of a standard for the Importation and Release into 

the Environment ofTransgenic Plants in NAPPO Member Countries (see 

http://www.nappo.orglStandards/Std-e.html). APHIS also participates in the North 

American Biotechnology Initiative (NABI), a forum for information exchange and 

cooperation on agricultural biotechnology issues for the U.S., Mexico and Canada. In 

addition, bilateral discussions on biotechnology regulatory issues are held regularly with 

other countries including: Argentina, Brazil, Japan, China, and Korea. Many countries, 

e.g. Argentina, Australia, Canada, China, Japan, Korea, Philippines, South Africa, 

Switzerland, the United Kingdom, and the European Union have already approved Bt 

35 
com varieties to be grown or imported for food or feed (AgBios 2010). There should be 

no effects on the U.S. com export market since Syngenta is actively pursuing regulatory 

approvals for the MIR162 com in countries with functioning regulatory systems for 

genetically modified organisms and that import com from the U.S. or Canada. 

Regulatory filings for the MIR162 com are in process for Colombia, Japan, South Korea, 

Taiwan, China, the Philippines, Australia and New Zealand, South Africa, the European 

Union, Russia, and Switzerland. 

COMPLIANCE WITH CLEAN WATER ACT AND CLEAN AIR ACT 

This EA evaluated the changes in com production due to the unrestricted use ofMIR162 

com. MIR162 com will not lead to the increased production of com in U.S. agriculture. 

The inclusion of the MIR162 com into com hybrids and their use in agriCUlture is not 

expected to have an adverse effect on water quality, water use, or air quality. There is no 

expected change in water use due to the production ofMIR162 com compared to current 

com production regimes, nor is it expected that air quality will change due to do the 

production ofMIR162 com. The commercial availability ofMIR162 is expected to 

continue to provide improvements in water quality similar to other commercially 

available GE insecticide resistant crops due the potential for continued reduction in use of 

more hazardous chemical pesticides, many ofwhich are toxic to aquatic organisms. 

36 
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46 
VII. PREPARERS, REVIEWERS, CONSULTANATIONS, 

AGENCY CONTACT 

Biotechnology Regulatory Services (BRS) 

Michael Gregoire, Deputy Administrator 

Beverly Simmons, Associate Deputy Administrator for Emerging and International 

Programs 

Sidney Abel, Assistant Deputy Administrator 

BRS, Environmental Risk Analysis Division 

Michael Watson, Ph.D., Division Director 


Susan M. Koehler, Ph.D., Branch Chief, Plants Branch (Reviewer) 


John Cordts, M.S., M.B.A., Biotechnologist (Reviewer) 


Subray Hegde, Ph. D., Biotechnologist (Preparer of Environmental Assessment) 


BRS, Policy and Coordination Division 

David Reinhold, Branch Chief, Communication & International Affairs Branch 

(Reviewer) 

Andrea Huberty, Ph. D., Branch Chief, Regulatory & Environmental Analysis Branch 

(Reviewer) 

Richard Coker, Regulatory Analyst 

Consultations 

Michael Mendelsohn, Senior Regulatory Specialist 

Office of Pesticide Programs/ Biopesticides & Pollution 

Prevention Division 

U.S. Environmental Protection Agency 

Agency Contact 

Ms. Cynthia Eck, Document Control Officer 

USDA, APHIS, BRS 

4700 River Road, Unit 147 

Riverdale, MD 20737-1237 

Phone: (301) 734-0667 

Fax: (301) 734-8669 

Cynthia.A.Eck@aphis.usda.gov 

47 
VIII. APPENDIX 

Appendix 1. Environmental and Human Health Safety of Vip3Aa20 

Protein 

Previously deregulated Bt com cultivars have resulted in reduced conventional pesticide 

use, as farmers find Bt products more effective in mitigating lepidopteran insect feeding 

damage. It is reasonable to expect that deregulation and commercialization ofthe 

MIR162 com will result in further reductions in the use of conventional pesticides. This 

reduction in conventional pesticide use would diminish the environmental risks of 

chemical pesticide insect control, as the chemical alternatives to MIR162 present wellcharacterized risks to humans and other wildlife, whereas Vip3Aa20 presents no such 

risk. Substantial data support a conclusion that Vip3Aa20 toxicity will be limited to 

sensitive lepidopteran species that are sufficiently exposed to the protein (USDA-APHIS 

2009). 

The toxicity ofinsecticidal Bt proteins, such as Vip3a20, depends on their binding to 

specific receptors present in the insect midgut. Research demonstrates that this 

specificity limits the proteins' toxic effect to certain lepidopteran species. A discussion 

on the mechanism of action for Vip3Aa20, its spectrum of activity, and its lack of 

toxicity to non-lepidopteran species is presented in the petition (pg. 47-50). 

Health and safety studies have been conducted with the novel proteins contained in 

MIR162 com. A comprehensive assessment ofthe safety ofthe introduced proteins, 

Vip3Aa20 and PMI, demonstrate that both proteins are nontoxic to mammalian species 

and are unlikely to be food allergens (69 FR 26770-26775; 73 FR 45620-45624; FDA 

BNF No. 000113). The Vip3Aa20 protein is considered nontoxic because it does not 

share significant amino acid homology with known protein toxins, is nontoxic to mice at 

a very high dose of 1250 mg Vip3Aa20lkg bw, is rapidly degraded in simulated 

mammalian gastric fluid, and its insecticidal mode of action for Vip3Aa20 is not relevant 

to mammals. 

Vip3Aa20 is also not likely to be a food allergen because it is not derived from a known 

source of allergenic proteins, it does not have any significant amino acid sequence 

identity to known allergenic proteins, it is rapidly degraded in simulated mammalian 

gastric fluid, and it is labile upon heating at temperatures of 65°C and above. The PMI 

protein is considered nontoxic because it does not share significant amino acid homology 

with known protein toxins, it is nontoxic to mice at a very high dose of 3030 mg PMIlkg 

bw, and it is rapidly degraded in simulated mammalian gastric fluid. PMI is not likely to 

be a food allergen because it is not derived from a known source of allergenic proteins, it 

does not have any significant amino acid sequence identity to known allergenic proteins 

with implications for its allergenic potential, it is rapidly degraded in simulated 

mammalian gastric fluid, and it is labile upon heating at temperatures of 37°C and above. 

48 
A pennanent exemption from the requirement of a food tolerance currently exists under 

73 FR 45620-4562440 for Vip3Aa20 in maize and under 40 CFR §180.1252 for PMI in 

all plants. 

USDA-APHIS. 2009. Plant Pest Risk Analysis for Syngenta MIR162 corn. USDA, 

APHIS, Biotechnology Regulatory Service. Riverdale, MD (URL: 

http://www .aphis. usda.gov Ibrs/notJeg.html) 

49 
Appendix IL Syngenta MIR162 Corn Forage and Grain Compositional 

Analysis 

The data for the discussion and interpretation on the composition analysis of the MIR162 

corn come from Syngenta's petition (Petition Appendix E, pages 158-180 for 

experimental details and statistical analyses, and pages 69-73 for the interpretation and 

discussion ofresults) and was reviewed by APHIS. The rationale for the composition 

analysis of forage and grain is to identify any changes in nutrient or anti-nutrient content 

of the new crop in the context of its use as food or feed and to assess its biochemical 

equivalence and similarity to conventional maize. Assessment of the plant's composition 

also allows the developer and APHIS to evaluate possible unintended effects that might 

arise from insertion of the Vip3Aa20 and PMI genes into the plant's genome. This 

assessment was undertaken by performing quantitative analyses of 65 components (Table 

25, pg. 70 in petition) both from MIR162 hybrid corn and a nontransgenic control 

variety. The analytes measured in this study were selected based on recommendations of 

the Organisation for Economic Co-operation and Development (OECD, 2002) for 

comparative assessment of composition of new varieties ofmaize. The plant materials for 

the analysis come from six diverse corn growing regions of the U.S. (Appendix Table E1, pg. 158 in petition) during 2005. Plants were self-pollinated by hand and the 

developing ears were bagged to avoid cross-pollination. All analyses were conducted 

using methods published and approved by the Association ofAnalytical Communities 

(AOAC) International or other industry-standard analytical methods. 

Nine components of corn forage were measured; the difference between MIR162 and 

control mean values was found to be statistically significant for one of these analytes. 

Fifty-six components of grain were measured; the difference between MIR162 and 

control mean values was found to be statistically significant for 13 ofthese analytes. The 

results for these 14 analytes that had a statistically significant outcome for genotype 

effect (Table 26, pg. 72 in petition) have been discussed in the following paragraphs. 

The forage compositional analyses for proximates and minerals revealed a single 

statistically significant difference between MIR162 and control mean values. The mean 

value for MIR162 Neutral Detergent Fiber (NDF) was 11.34% higher than the 

corresponding control value. This difference is considered relatively small and the 

MIR162 mean falls well within the range ofnormal values reported by International Life 

Sciences Institute (ILSI) (Ridley et al. 2004; ILSI 2006) and Organisation for Economic 

Co-operation and Development (OECD). No statistically significant genotype by 

location interactions were noted for the forage compositional analyses. 

Compositional analyses of grain revealed no statistically significant differences between 

MIR162 and control means for 43 of the 56 analytes examined in across-location 

comparisons. Statistically significant differences were noted for levels of the proximates 

ash, NDF, starch, three grain minerals (calcium, iron, and phosphorus), levels of vitamin 

A (~-carotene), vitamin B6 (pyridoxine), and vitamin E (a-tocopherol), linoleic and 

linolenic fatty acids. These differences were small « 8%) and the MIR162 mean values 

50 
were well within the ranges of nonnal values for the control maize. Additionally, the 


average values for all proximates were within the ranges reported by ILSI and OECD. 


Statistically significant differences were noted between MIR162 and control mean levels 


of vitamin A (~-carotene), vitamin B6 (pyridoxine), and vitamin E (a-tocopherol). These 


differences were small « 7%) and the mean values observed for these vitamins in the 


MIR162 grain were well within the range of values observed for the control grain. 


Additionally, the MIR162 means for all vitamins fell within the nonnal range ofvalues 


reported for conventional maize by ILSI and OECD. For vitamin A and vitamin B9 a 


statistically significant genotype-by-Iocation interaction was noted, which suggests that 


the effect of genotype was not consistent across locations, hence, the comparison of 


genotypes averaged across locations may not be valid. Individual location means for the 


two analytes are provided in Table E-8 (Appendix E). The vitamin A and vitamin B9 


levels at all locations were within the ranges reported in the literature. 


There were no significant differences noted for any ofthe 18 amino acids or anti­


nutrients measured and all average values were within the ranges reported by ILSI and 


OECD (Appedix E, pg. 158-180 in petition). 


Statistically significant differences were noted for linoleic and linolenic fatty acids. 


These differences were very small « 4%) and the MIR162 mean values observed for 


these fatty acids were within the ranges of values observed for the control grain. 


Furthennore, the average values for all fatty acids were within the range ofnonnal values 


reported for conventional maize by ILSI and OECD. 


Statistically significant differences were noted in the secondary metabolites ferulic acid 


and p-cournaric acid. These differences were relatively small « 15%) and the MIR162 


mean values for these secondary metabolites were within the ranges of values observed 


for the control grain. Additionally, the mean values for all MIR162 secondary 


metabolites and anti-nutrients were within the nonnal range ofvalues reported for 


conventional maize by ILSI and OECD. 


Collectively, the observed differences between MIR162 and control means are 


considered of no biological significance and represent typical random variance. The 


magnitude of the differences was small, all MIR162 values fell within normal ranges for 


conventional maize, and the MIR162 and control data ranges significantly overlapped. 


MIR 162 is therefore, not compositionally different from conventional maize. 


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