NATIONAL ENVIRONMENTAL POLICY ACT DECISION 


AND 


FINDING OF NO SIGNIFICANT IMPACT 


Syngenta Biotechnology Incorporated 


MIR162 Maize 


SYN-IR162-4 


United States Department of Agriculture 


Animal and Plant Health Inspection Service 


Biotechnology Regulatory Services 


This National Environmental Policy Act (NEPA) decision document has been developed 

by U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service 

(APHIS) in compliance with the requirements of the National Environmental Policy Act 

of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations 

implementing NEP A, and the USDA and APHIS NEP A implementing regulations and 

procedures. This NEP A decision document is intended to state APHIS' NEP A decision 

and present the rationale for its selection. 

In accordance with APHIS procedures implementing the NEP A Regulations (7 CFR part 

372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine 

if there are any potentially significant impacts to the human environment following a 

determination ofnonregulated status of a petition request (APHIS number 07-253-01 p) 

by Syngenta Biotechnology, Inc. (hereafter "Syngenta") for their transgenic event 

MIR162 in com (hereafter "MIRI62 com"). Syngenta MIR162 com is a genetically 

engineered (GE) Zea Mays (com) hybrid variety that was genetically engineered to be 

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. MIR162 com has been engineered to express the bacterial protein Vip3Aa20 

from Bacillus thuringiensis that is toxic to 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. 

APHIS has evaluated the plant pest risks posed by the production ofSyngenta MIR162 

and prepared an EA to identify and evaluate any environmental impacts resulting from 

the approval of the petition for nonregulated status. The EA assesses alternatives to 

granting nonregulated status to Syngenta MIRl62 and analyzes the potential 

environmental and social effects that result from the proposed action and the alternatives. 

The proposed action ofUSDA APHIS, Biotechnology Regulatory Services (BRS) is to 

grant nonregulated status to Syngenta MIR162 and remove this GE com variety from 

APHIS' regulatory oversight in accordance with 7 CFR part 340. Comments from the 
public involvement process were reviewed for substantive issues which were considered 

in developing this NEPA decision. 

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 United States: USDA-APHIS, the U.S. Department of 

Health and Human Services' Food and Drug Administration (FDA), and the 

Environmental Protection Agency (EPA). Products are regulated according to their 

intended use and some products are regulated by more than one agency. USDA-APHIS, 

FDA, and EPA enforce agency-specific regulations on products of biotechnology that are 

based on the specific nature of each GE organism. Together, these agencies ensure that 

the products ofmodern biotechnology are safe to grow, safe to eat, and safe for the 

environment. 

APHIS regulates GE organisms under the Plant Protection Act of 2000. USDA APHISBRS' mission is to protect America's agriculture and environment using a dynamic and 

science-based regulatory framework that allows for the safe development and use ofGE 

organisms. APHIS regulations at 7 CFR part 340, which were promulgated pursuant to 

authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 

7701-7772), regulate the introduction (importation, interstate movement, or release into 

the environment) of certain GE organisms and products. A GE organism is considered a 

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

engineering the organism belongs to one ofthe taxa listed in the regulation (7 CFR § 

340.2) and is also considered a plant pest. A GE organism is also regulated under part 

340 when APHIS has reason to believe that the GE organism may be a plant pest or 

APHIS does not have sufficient information to determine ifthe 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 § 340.6 "Petition for Determination ofNonregulated 

Status." The petitioner is required to provide information (§ 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. After receipt of a petition, 

as per the requirements of § 340.6, BRS makes a determination on whether an organism 

is not likely to pose a plant pest risk and is therefore no longer subject to the regulatory 

requirements of 7 CFR part 340. A GE organism is no longer subject to the regulatory 

requirements of 7 CFR part 340 when APHIS determines that it is not likely to pose a 

plant pest risk. 

FDA regulates 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. Syngenta MIR162 corn has successfully completed the consultation 

process with the FDA concerning food and feed safety (BNF No. 000113). FDA has no 

more questions on nutritional or safety issues, and has provided a summary response and 

"concluded that maize forage and grain from the new variety are not materially different 

in composition, safety, and other relevant parameters from maize forage and grain 

currently on the market and that the genetically engineered maize event MIR162 does not 

raise issues that would require premarket review or approval by FDA." 

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). Because Syngenta MIR162 corn does contain 

genetically engineered pesticides, EPA registration was pursued by Syngenta. A 

tolerance for the insecticidal Vip3Aa20 protein that is contained in Event MIR162 was 

registered by EPA (2008). EPA has approved the conditional registration for MIR162 

and the two corn hybrids Btl 1 x MIR162 and Btl 1 x MIR162 x MIR604 (74 FR 19956­

19957) and determined that the use of this pesticide ''will not cause any unreasonable 

effects on the environment during the time of conditional registration" (EPA 2009). 

Document History 

On September 10, 2007 APHIS BRS received a petition from Syngenta Biotechnology, 

Incorporated seeking a determination ofnonregulated status for MIR 162 com. An 

amended version of the petition was received on November 14,2007 and final additional 

data and response to BRS questions was dated July 16,2008. Upon receipt ofthe final 

submissions, BRS reviewed the information and deemed the petition complete on July 

23,2008. Based upon information provided in the petition and review of the scientific 

literature, BRS prepared a Draft EA and Plant Pest Risk Assessment (PPRA) (USDAAPHIS 2010). 

Public Involvement 

On January 13, 2010, APHIS published a notice in the Federal Register (75 FR 1749­

1751, Docket no. APHIS-2009-0072) announcing the availability of the Syngenta petition 

requesting nonregulated status for MIR162 com, a Draft PPRA and a Draft EA for a 60 

day public comment period. This comment period ended on March 15, 2010. In total, 35 

comments were received from the public. All comments were analyzed to identify new 

issues, alternatives, or information. Responses to the substantive comments are attached 

to the docket submitted to the Federal Register with this Finding. 

Major Issues Addressed in the EA 

The EA describes the alternatives considered and evaluated using the identified issues. 

Issues considered in the EA were developed based on APHIS' determination to grant 

nonregulated status for certain genetically engineered organisms and for this particular 

EA, the specific deregulation ofSyngenta MIR162 corn. The following issues were 

identified as important to the scope ofthe analysis (40 CFR 1508.25): 

Com 
• Gene Movement (Pollen Flow) 

• Weediness 

• Human Health 

• Animal Feed 

Agricultural Production ofCom 

• Growing Regions and Acreage 

• Organic and Conventional Com Production 

• Seed Production 

Insect Control Practices 

• Insect Pests and Disease 

• Mycotoxin Contamination 

• Insecticide Use 

Impacts on Non-target Organisms 

• Higher Organisms 

• Above Ground Arthropods 

• Threatened and Endangered Species 

• Soil Dwelling Organisms 

Socioeconomic Impacts 

• Agricultural 

• Human Health and Environment 

• Insect Resistance Management 

• Export Market 

Affected Environment: 

Although the preferred alternative would allow for plantings of Syngenta MIR 162 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) 2007 Census of 

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

2009). Forty-nine states produce com in the U.S. according to the 2007 Census of 

Agriculture. Syngenta MIR162 com will likely partially replace some existing com 

varieties because of grower needs and preferences. However, MIR162 does not express 

new agronomic traits or resistance traits useful against a geographically limiting insect 

species. Consequently, growers will not likely plant new land beyond that currently or 

historically used for com production ifthis trait is made commercially available. 

Alternatives that were fully analyzed: 

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

nonregulated status to MIR162 com. In order for MIR162 com to be granted 

nonregulated status, it must be found to be unlikely to pose a plant pest risk. The analysis 

provided in the plant pest risk assessment (USDA-APHIS 2009) demonstrates that there 

is sufficient data to determine that MIR162 com is unlikely to pose a plant pest risk; thus 

APHIS has no regulatory authority over MIR162 com and this GE com variety is eligible 

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

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

plant pest risk, the only action alternative considered in the EA is to granting 

nonregulated status "in whole" to MIR162 com. Approval in part can be given if there is 

a plant pest risk associated with some but not all lines requested in a petition. The 

petition for MIR162 com only requested APHIS to grant nonregulated status to one com 

line, so this "in part" approval will not be considered. Thus, there are two alternatives 

that are considered in this EA: (1) no action and (2) to grant nonregulated status to 

MIRl62 com, "in whole." 

Alternative A. No Action: Continuation as a Regulated Article 

Under the "no action" alternative, APHIS would deny the petition. MIRl62 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 

MIRl62 com and measures to ensure physical and reproductive confinement would 

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

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

cultivation ofthe MIR 162 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 ofAPHIS to allow 

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

unlikely to pose a plant pest risk. 

Alternative 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. MIRl62 com is eligible for nonregulated 

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 if there 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 if the 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 corn as well as conventional corn varieties. If 

commercialized, MIR162 corn 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 corn is unlikely to pose a plant pest risk (USDA-APHIS 2009). By granting 

nonregulated status to MIR162 corn, 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 corn, there is no geographic differences in the plant pest risks for MIR162 

corn (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 corn and will be unable to impose regulatory 

restrictions on this GE corn variety. 

Environmental Consequences of APHIS' Selected Action 

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

specific details. The foHowing table briefly summarizes the results for each of the issues 

fully analyzed in the Environmental Consequences section of the EA. 

Tabill e ssues AnIa yze d an dOther R egu It a ory At" c Ions 

AttributelMeasure Alternative A Alternative B 

No Action Deregulation in Whole 

(!'retJ!rred Alternativei 

Meets APHIS Purpose and No Yes 

Need and Ob.iectives 

Unlikely to pose a plant pest Satisfied through use of ~iSfied-riSk assessment 

risk regulated field trials SDA-APHIS 2009) 

Farmer choice Not available commercially No restrictions 

Corn 

Gene Movement (Pollen Minimal Minimal 

Flow) 

Weediness None None 

Human Health Unchanged FDA approved safety of 

changes 

Animal Feed Unchanged FDA approved safety of 

changes 

Agricultural Production of 

Corn 

Growing Region and Unchanged ed ~ 

Acreage 

Organic and Conventional Unchanged Unchanged 

Corn Production 
Seed Production Unchanged Unchanged 

Insect Control Practices 

Insect Pests and Disease 

Management Practices 

Unchanged Unchanged 

Mycotoxin Contamination Unchanged May decrease 

Insecticide Use 

Impacts on Non Target 

Organisms 

Higher Organisms 

I Above Ground Arthropods 

I::

Unchanged 

May decrease 

Unchanged 

Unchanged 

Threatened and Endangered 

Species 

Unchanged Unchanged 

Soil Dwelling Organisms 

Socioeconomic Impacts 

Agricultural 

Human Health and 

Environment 

~ ~anged anged 

Unchanged 

May improve 

May improve • 

Insect Resistance 

Management 

Unchanged May improve 

Export Market Unchanged Unchanged 

Other Regulatory 

Approvals 

U. S. Completion ofFDA 

consultation. Registration 

by EPA and tolerance 

allowed 

Completion of FDA 

consultation. Registration 

by EPA and tolerance 

allowed 

Foreign Trade Approvals from Australia, 

Brazil, Japan, Mexico, 

Philippines, Taiwan 

Approvals from Australia, 

Brazil, Japan, Mexico, 

Philippines, Taiwan 

Compliance with Other 

Laws 

CWW, CAA. EOs Fully compliant Fully compliant 

Finding of No Significant Impact 

The analysis in the EA indicates that there will not be a significant impact, ind'ividually or 

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

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

NEP A determination is based on the following context and intensity factors (40 CFR 

1508.27): 

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

location and setting in which the environmental impact would occur. This action has 

potential to affect conventional and organic com production systems, including 

surrounding environments and agricultural workers; human food and animal feed 

production systems; and foreign and domestic commodity markets. As identified in the 
Affected Environment section above, although the preferred alternative would allow for 

new plantings ofMIRl62 com to occur anywhere in the U.S., the environmental analysis 

is limited to those areas that currently support corn production in forty-nine states. 

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

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

1. 	 Impacts that may be both beneficial and adverse. 

Granting nonregulated status to MIR162 com will have no significant impact on 

the availability of GE, conventional, organic or specialty corn varieties or com 

production systems. As discussed in Chapter 6 of the EA, if deregulated by 

APHIS, MIR162 com would be an additional GE insect resistant corn variety 

available to growers for commercial production and there are no foreseeable 

changes to the availability ofGE, conventional, organic or specialty corn varieties 

on the market. Nontransgenic com wi1llikely still be sold and will be readily 

available to those who wish to plant it. Syngenta MIR162 corn will likely 

partially replace some existing com varieties because of grower needs and 

preferences. However, MIR162 does not express new agronomic traits or 

resistance traits useful against a geographically limiting insect species. 

Consequently, growers will not likely plant new land beyond that currently or 

historically used for corn production if this trait is made commercially available. 

As discussed in Chapter 6 ofthe EA, the introduction ofMIR162 corn will have a 

positive impact on current corn insect control practices. MIR162 corn has the 

potential to control above-ground insect pests including corn earworm, black 

cutworm, western bean cutworm, and fall armyworm that are not controlled by 

the Bt corn varieties expressing Cry proteins. This product has the potential to 

displace many conventional insecticide applications on corn resulting in a 

reduction in the number of pounds of insecticides that may be used to protect com 

from insect damage. MIR162 will also 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. 

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

The proposed action to grant nonregulated status to MIR 162 corn would have no 

significant impacts on human or animal health. MIR162 is not materially 

different in composition, safety, or any other relevant parameter from corn now 

grown, marketed, and consumed, except for the expression of Vip protein. As . 

described in Chapter 6 of the EA, numerous corn varieties that express other Bt.­

derived proteins are currently available and have been used safely in the 

marketplace since 1996. FDA completed the safety and nutritional assessment for 

this product and had no further questions regarding the safety of Syngenta 

MIR162 corn (FDA 2009). Based on the assessment of the evidence provided in 

the petition and accompanying scientific literature, and on the assessments of 

EPA and FDA, APHIS has concluded that Syngenta MIR162 com would have no 

significant impacts on human or animal health. 
3. 	 Unique characteristics ofthe geographic area such as proximity to historic or 

cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, 

or ecologically critical areas. 

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

farm lands, wetlands, wild and scenic areas, or ecologically critical areas that 

would be significantly affected. MIR162 will only be grown in areas suitable for 

the production of com and those historically used for com production. There is 

no significant difference in performance or agricultural practices for growing 

MIR162 com compared to other com varieties (aside from reduced control 

measures for certain lepidopterous pest insects), and no natural resources or land 

usage will be significantly altered through the production ofMIR162 com. 

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

to be highly controversial. 

The effects on the quality of the human environment are not highly controversial. 

Although there is some opposition to the granting of nonregulated status to 

MIR162 com, this action is not highly controversial in terms of size, nature or 

effect. Other than objections to all genetically engineered crops, the public 

comments did not register any specific factual concerns with the data provided 

APHIS for this crop or its analysis, both of which were presented in the EA. 

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

uncertain or involve unique or unknown risks. 

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

environment would not be significant. The effects of the proposed nonregulated 

status for MIR162 are not highly uncertain and do not involve unique or unknown 

risks. As described in Chapters 4 and 6 of the EA, well established management 

practices, production controls, and production practices (GE, conventional, and 

organic) are currently being used in com production systems in the US. 

Therefore, it is reasonable to assume that farmers, who produce conventional 

com, MIR162 com, or produce com using organic methods, will continue to use 

these reasonable, commonly accepted best management practices for their chosen 

system and varieties for agricultural com production. Additionally, 85% of the 

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

in 2009, 63% were GE Bt or Bt-stacked com varieties (USDA-NASS 2009a). 

The availability ofMIR162 com would offer growers and manufacturers another 

choice of com resistant to insects in addition to the options already available. 

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

significant effects or represents a decision in principle about a future 

consideration. 

The proposed action would not establish a precedent for future actions with 

significant effects or represent a decision in principle about a future decision. 

Similar to past petitions for nonregulated status (USDA-APHIS 2010), APHIS 

decision on the regulatory status ofMIR162 com will be based upon information 

provided in the petition submitted by the applicant. APHIS regulations at 7 CFR 

part 340, regulate the introduction (importation, interstate movement, or release 

into the environment) of certain GE organisms and products. 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 § 340.6 "Petition for Determination of 

Nonregulated Status." After receipt of a petition, BRS makes an independent 

determination about whether an organism is unlikely to pose a plant pest risk and 

is therefore no longer subject to the regulatory requirements of 7 CFR part 340. 

Each petition that APHIS receives undergoes this independent review to 

determine if the regulated article poses a plant pest risk. 

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

cumulatively significant impacts. 

No significant cumulative effects were identified through this assessment. The 

EA evaluated the potential cumulative impacts of granting nonregulated status to 

MIR162 com including the effects on com production, genetic purity of com 

germplasm, genetic diversity of com, insect resistance, threatened and endangered 

species and biodiversity. A cumulative effects analysis is included in Chapter 6 

ofthe EA. If granted nonregulated status, MIR162 com may be stacked 

(combined) with conventional varieties or other nonregulated GE com varieties 

by traditional breeding techniques, resulting in com that, for example, may also 

be resistant to herbicides or other insects. EPA has approved the conditional 

registration ofMIR162 stacked com hybrids. As presented in the EA, 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 CrylAb 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 of these 

conditional registrations involving MIR 162 and the hybrids (74 FR 19956­

19957). There is no guarantee that MIR162 com will be stacked with any 

particular deregulated GE variety, as company plans and market demands playa 

significant role in those business decisions. Postulating and predicting any and all 

potential combinations ofstacked varieties that could be created using both 

deregulated GE com varieties and also non-GE com varieties is too hypothetical 

and purely speCUlative. 

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

structures, or objects listed in or eligible for listing in the National Register of 

Historic Places or may cause loss or destruction ofsignificant scientific, cultural, 

or historical resources. 

MIR162 com would have no impact on districts, sites, highways, structures, or 

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

nor would they likely cause any loss or destruction of significant scientific, 

cultural, or historical resources. Granting nonregulated status to MIR162 com 

will not cause an increase in agricultural acreage devoted to com production, or to 

acres devoted to GE com cultivation. MIR162 com will also not change future 

cultivation areas for com production in the U.S. This com variety does not 

express new agronomic traits or resistance traits useful against a geographically 
limiting insect species. Consequently, growers will not likely plant new land 

beyond that currently or historically used for corn production if this trait is made 

commercially available. 

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

species or its habitat that has been determined to be critical under the 

Endangered Species Act of1973. 

APHIS evaluated the potential for negative effects on federal threatened and 

endangered species as listed by the U.S. Fish and Wildlife Service from 

cultivation ofMIRl62 corn and its progeny and determined that the release of 

MIR162 corn, following a determination ofnonregulated status, would have no 

effect on federally listed threatened or endangered species or species proposed for 

listing, or on designated critical habitat or habitat proposed for designation (see 

section on Threatened and Endangered Species, Chapter 6 ofthe EA). 

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

requirements imposed for the protection ofthe environment. 

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

laws. The proposed action to grant nonregulated status to MIR162 and remove 

this GE corn variety from APHIS' regulatory oversight would be carried out in 

accordance with 7 CFR part 340. MIR162 corn has successfully completed the 

consultation process with the FDA concerning food and feed safety (Appendix 1 

of the EA). MIR162 corn expresses a genetically engineered pesticide and 

registration ofthis product as well as a tolerance for its plant-expressed 

insecticidal protein was required from EPA (EPA 2008, 2009, 2009a). There are 

no other Federal, state, or local permits that are needed prior to the 

implementation ofthis action. A list of the current status ofU.S. and international 

approvals is found in Table 1 ofthis Decision Document. 

NEPA Decision and Rationale 

I have carefully reviewed the EA prepared for this NEP A determination and the input 

from the public involvement process. I believe that the issues identified in the EA are 

best addressed by selecting Alternative B - Grant nonregulated status to Syngenta 

MIR162 corn, "in whole". 

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative 

which the agency believes would fulfill its statutory mission and responsibilities, giving 

consideration to economic, environmental, technical and other factors." The preferred 

alternative has been selected for implementation based on consideration of a number of 

environmental, regulatory, and social factors. Based upon our evaluation and analysis, 

Alternative B is selected because (1) it allows APHIS to fulfill its statutory mission to 

protect America's agriculture and environment using a dynamic and science-based 

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

engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. Since 

APHIS has concluded that that Syngenta MIR162 corn is unlikely to pose a plant pest 

risk, APHIS has no authority to continue to regulate a GE organism once it has 

determined that the GE organism does not pose a plant pest risk. The comments 
identified from public involvement did not change the results ofthe analysis. Therefore, 

it is my decision to implement the preferred alternative as described in the EA. 

Mike Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Services 

U.S. Department of Agriculture 

Literature Cited: 

EPA 2008. Bacillus thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic 

Material Necessary for Its Production (via Elements of Vector pNOV1300) in 

Event MIR162 Maize (OECD Unique Identifier: SYN-IR162-4)(006599) Fact 

Sheet. US Environmental Protection Agency. 

http://www.epa.gov/pesticideslbiopesticides/ingredients/factsheets/factsheet 0065 

99.html. 

EPA 2009. Bacillus thuringiensis CrylAb Delta-Endotoxin Protein and the Genetic 

Material Necessary for Its Production (via Elements of Vector pZ01502) in Event 

Btll Com (OECD Unique Identifier: SYN-BT011-1)(006444) & Bacillus 

thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic Material Necessary 

for Its Production (via Elements of Vector pNOV1300) in Event MIR162 Maize 

(OECD Unique Identifier: SYN-IRI62-4)(006599) Fact Sheet. US Environmental 

Protection Agency. 

http://www.epa.gov/pesticideslbiopesticides/ingredients/factsheets/factsheet 0065 

99-006444.html 

EPA 2009a. Bacillus thuringiensis CrylAb Delta-Endotoxin Protein and the Genetic 

Material Necessary for Its Production (via Elements ofVectorpZOl502) in Event 

Btl I Com (OECD Unique Identifier: SYN-BT011-1)(006444) & Bacillus 

thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic Material Necessary 

for Its Production (via Elements of Vector pNOV1300) in Event MIRl62 Maize 

(OECD Unique Identifier: SYN-IRI62-4)(006599) & Modified Cry3A Protein 

and the Genetic Material Necessary for Its Production (via Elements of Vector 

pZM26) in Event MIR604 Com (OECD Unique Identifier: SYN-IR604­

5)(006509) Fact Sheet. US Environmental Protection Agency. 

http://www . epa. gov Ioppbppd llbiopesticides/ingredients/factsheetsl factsheet _0065 

99-006444-006509.htm 

FDA (2009) Bioteclmology Consultation Note to the file on corn event MIRl62 (BNF 

No. 000113). 
http://www.fda.gov/Food/Biotechnology/Submissions/ucmI55598.htm (Accessed 

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