NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND FINDING OFNO SIGNIFICANT IMPACT

Syngenta Biotechnology Incorporated MIR162 Maize

SYN-IR162-4

United StatesDepartment ofAgriculture Animal and PlantHealth Inspection Service Biotechnology Regulatory Services

This National Environmental Policy Act (NEPA) decision document has been developed byU.S. Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) in compliance with the requirements ofthe National Environmental Policy Act of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementingNEPA, and the USDA and APHIS NEPA implementingregulations and procedures. This NEPA decision document is intended to state APHIS' NEP A decision and present the rationale for its selection.

In accordance with APHIS procedures implementing the NEPA Regulations (7 CFRpart 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment following a determination ofnonregulated status ofa petition request (APHIS number 07-253-01p) by SyngentaBiotechnology, Inc. (hereafter "Syngenta") for their transgenic event MIR162 in com (hereafter "MIRI62 com"). SyngentaMIR162 comis a genetically engineered (GE) Zea Mays (com) hybrid varietythat 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 (Striacosta albicosta) larvae that are not controlled well with existing technology. MIR162 comhas been engineered to express the bacterial protein Vip3Aa20 from Bacillus thuringiensis that is toxic to certain lepidopteran insect pests. This comis also engineered to express anotherprotein, phosphomannose isomerase (PMI) from Escherichia coli, which was used as a selectable marker to identifycom seedlings containing Vip3Aa20 gene during the development ofMIR162 com.

APHIS has evaluated the plant pest risks posed bythe production ofSyngentaMIR162 and prepared an EAto identify and evaluate any environmental impacts resulting from the approval ofthe petition for nonregulated status. The EA assesses alternatives to granting nonregulated status to SyngentaMIRl62 and analyzes the potential environmental and social effects that result from the proposed action and the alternatives. The proposed action ofUSDA APHIS, BiotechnologyRegulatory Services (BRS) is to grant nonregulated status to SyngentaMIR162 and remove this GE com variety from APHIS' regulatory oversight in accordance with 7 CFRpart 340. Comments from thepublic involvement process were reviewed for substantive issues which were considered in developing this NEPA decision.

In 1986, the Federal Government's Office ofScience and TechnologyPolicy (OSTP) published a policydocument 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 bymore than one agency. USDA-APHIS, FDA, and EPA enforce agency-specific regulations on products ofbiotechnologythat are based on the specific nature ofeach GE organism. Together, these agencies ensure that the products ofmodernbiotechnology are safe to grow, safe to eat, and safe for the environment.

APHIS regulates GE organisms under the Plant Protection Act of2000. 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 bythe Plant ProtectionAct, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is considered a regulated article ifthe 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 underpart 340 whenAPHIS has reason to believe that the GE organismmaybe a plant pest or APHIS does not have sufficient information to determine ifthe GE organism is unlikely
to pose a plant pest risk.

A personmaypetition the agencyto evaluate submitted data and determine that a particularregulated article is unlikely to pose a plant pestrisk, and, therefore, shouldno longerberegulated, under 7 CFR § 340.6 "Petition for Determination ofNonregulated Status." The petitioneris required to provide information (§ 340.6(c)(4)) related to plant pest risk that the agency uses to determine whetherthe regulated article is unlikelyto present a greaterplant pest risk than the unmodified organism. Afterreceipt ofa petition,

as pertherequirements of§ 340.6, BRS makes a determination onwhether an organism is not likelyto pose a plantpestrisk and is therefore no longer subject to the regulatory requirements of7 CFR part 340. A GE organism is no longer subject to the regulatory requirements of7 CFR part 340when APHIS determines that it is not likely to pose a plantpest risk.

FDA regulates underthe authority ofthe Federal Food, Drug, and Cosmetic Act. The FDA policy statement concerningregulation ofproducts derived from new plant varieties, including those geneticallyengineered, was published in the Federal Register

on May 29, 1992 (57 FR 22984-23005). Underthis policy, FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues or otherregulatory issues (e.g., labeling) are resolved 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 summaryresponse and "concluded that maize forage and grain from the new variety are not materially different in composition, safety, and otherrelevant 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 premarketreview orapproval byFDA."

The EPAregulates 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 SyngentaMIR162 corn does contain genetically engineered pesticides, EPAregistration was pursuedby Syngenta. A tolerance for the insecticidal Vip3Aa20 protein that is contained in Event MIR162 was registered byEPA (2008). EPA has approved the conditional registration for MIR162 and the two corn hybrids Btl 1 x MIR162 and Btl1 x MIR162 x MIR604 (74 FR 19956­ 19957) and determined that the use ofthis pesticide ''will not cause any unreasonable effects on the environment during the time ofconditional registration" (EPA 2009).

Document History On September 10, 2007 APHIS BRS received a petition from SyngentaBiotechnology, Incorporated seeking a determination ofnonregulated status for MIR162 com. An amended version ofthe petition was received onNovember 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 informationprovided in the petition and review ofthe 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 ofthe Syngentapetition requesting nonregulated status for MIR162 com, a Draft PPRA and a Draft EA for a 60 day public commentperiod. This comment period ended onMarch 15, 2010. Intotal, 35 comments were received from the public. All comments were analyzed to identify new issues, alternatives, orinformation. Responses to the substantive comments are attached to the docket submitted to the Federal Register with this Finding.

MajorIssues Addressed in the EA The EA describes the alternatives considered and evaluated using the identified issues. Issues considered inthe EA were developed based onAPHIS' determination to grant nonregulated status for certain genetically engineered organisms and for this particular EA, the specific deregulation ofSyngentaMIR162 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 ComProduction

• Seed Production Insect Control Practices

• Insect Pests and Disease

• Mycotoxin Contamination

• Insecticide Use Impacts on Non-targetOrganisms

• 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 ofSyngenta MIR162 comto

occur anywhere in the U.S., APHIS limited the environmental analysis to those areas that currently support com production. To determine areas ofcomproduction, APHIS used data from the National Agricultural Statistics Service (NASS) 2007 Census of Agriculture to determine where com isproduced inthe United States (USDA-NASS. 2009). Forty-nine statesproduce cominthe U.S. according to the 2007 Census of Agriculture. SyngentaMIR162 comwill likelypartiallyreplace some existing com varieties because ofgrowerneeds and preferences. However, MIR162 does not express
new agronomic traits orresistance traits useful against a geographicallylimiting insect species. Consequently, growers will not likelyplantnew landbeyondthat currently or historically used for comproduction ifthistrait is made commercially available.

Alternatives that were fully analyzed: The EA analyzes the potential environmental consequences ofa proposal to grant nonregulated status to MIR162 com. In orderfor MIR162 comto be granted nonregulated status, it mustbe found to be unlikely to pose a plantpest risk. The analysis provided in the plant pestrisk 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 "inwhole" to MIR162 com. Approval in part can be given ifthere is

a plant pest risk associated with some but not all lines requested in a petition. The petition for MIR162 com onlyrequested APHIS to grant nonregulated status to one com line, so this "inpart" 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, "inwhole."

Alternative A. No Action: Continuation as a Regulated Article Under the "no action" alternative, APHIS would denythe petition. MIRl62 com and its progenywould continue to be regulated under 7 CFRpart 340. Permits issued or notifications acknowledged byAPHIS 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 ofplantpest risk from the unconfined cultivation oftheMIR 162 com and its progeny.

Under this no action alternative, growers and other parties who are involved in production, handling, processing orconsumption ofcomwould continue to have access to existing deregulated GE insect resistant com as well as conventional comvarieties. However, growers would not have widespread access to the MIR162 com since it would continue to beregulated 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 comis unlikely to pose aplant pest risk (USDA-APHIS 2009). Choosing this alternative would hinderthe purpose and need ofAPHIS to allow for the safe development and use ofGEorganisms given that the MIR162 comis unlikelyto pose a plant pestrisk.

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 progenywould no longer beconsidered regulated articles under 7 CFR part 340. Permits ornotifications acknowledged by APHIS would no longerberequired for introductions in the.United States and its territories oftheMIR162 com orits 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 ifthere was sufficient evidence to demonstrate the lack ofplantpestrisk associated from the unconfined release ofthis insect resistant com event.

Under this alternative, growers mayhave 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 otherparties who are involved inproduction, handling, processing orconsumption ofcom would continue to have access to existingderegulated GE insect resistant corn as well as conventional corn varieties. If commercialized, MIR162 corn will likelybe introduced in areas where com is currently grown and is not expected to alter the current range ofcom 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 plantpest risk (USDA-APHIS 2009). Bygranting nonregulated status to MIR162 corn, the purpose and need to allow the safe development and use ofGE organisms is met.

Alternatives ConsideredbutRejected from Further Consideration: Geographic restrictions -APHIS considered geographic restrictions based upon geographic variation inplantpest risk. As presented in APHIS plant pest risk assessment for MIR162 corn, there is no geographic differences in the plant pestrisks for MIR162

corn (USDA-APHIS 2009). This alternative was rejected and not analyzed in detail because MIR162 com is unlikely to pose aplantpest risk and therefore, APHIS will have

no regulatory authority overMIR162 corn and will be unable to impose regulatory restrictions on this GE corn variety.

EnvironmentalConsequences ofAPHIS' Selected Action The EA contains a full analysis ofthe alternatives to which we refer the reader for specific details. The foHowing tablebriefly summarizes the results for each ofthe issues fully analyzed inthe Environmental Consequences section ofthe EA.

Ta billssues AnI a yzed dOther R It c Ions e an egu a ory At" AttributelMeasure AlternativeA AlternativeB NoAction Deregulation in Whole (!'retJ!rredAlternativei

Meets APHIS Purpose and No Yes Need and Ob.iectives Unlikely to pose aplantpest Satisfied through use of**~iSfied-riSk** assessment risk regulated field trials SDA-APHIS 2009) Farmerchoice 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 safetyof changes Agricultural Production of Corn Growing Region and Unchanged ed**~** Acreage Organic and Conventional Unchanged Unchanged Corn ProductionSeed 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 HigherOrganisms

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

Mayimprove May improve

• Insect Resistance Management Unchanged May improve

Export Market Unchanged Unchanged OtherRegulatory Approvals U. S. Completion ofFDA consultation. Registration by EPA and tolerance allowed Completion ofFDA consultation. Registration byEPA 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 ofNo SignificantImpact The analysis in the EA indicates that there will not be a significant impact, ind'ividually or cumulatively, on the quality ofthe human environment as a result ofthis proposed action. I agree with this conclusion and therefore find that an EIS need not beprepared. This NEPA determination is based on the following context and intensity factors (40 CFR 1508.27):

Context

- The term "context"recognizes potentially affected resources, as well as the location and setting in which the environmental impact would occur. This action has potential to affect conventional and organic comproduction systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commoditymarkets. As identified intheAffected 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 ofthe degree or severityofan impact based upon the ten factors. The following factors were used as abasis for this decision:

1. Impacts that may be both beneficialandadverse. Granting nonregulated status to MIR162 comwill have no significant impact on the availability ofGE, conventional, organic or specialty corn varieties orcom production systems. As discussed in Chapter 6 ofthe EA, ifderegulated 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. SyngentaMIR162 corn will likely partiallyreplace some existing com varieties because ofgrower 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 likelyplant new land beyond that currently or historicallyused for corn production ifthis 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 armywormthat are not controlledby 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 ofpounds ofinsecticides that maybe used to protect com from insect damage. MIR162 will also provide farmers with an additional management option that will likelyhelp farmers increase their capacity to alleviate adverse affects ofmycotoxins on crops and animals. 2. The degree to which theproposedaction affectspublic health orsafety. Theproposed action to grant nonregulated status to MIR162 corn would have no significant impacts on human or animal health. MIR162 is not materially different in composition, safety, orany otherrelevant parameter from corn now grown, marketed, and consumed, except for the expression ofVip protein. As

. described in Chapter 6 ofthe EA, numerous corn varieties that express otherBt.­ derived proteins are currently available and have been used safely in the marketplace since 1996. FDAcompleted the safety and nutritional assessment for this product and had no further questions regarding the safety ofSyngenta MIR162 corn (FDA 2009). Based on the assessment ofthe evidenceprovided in the petition and accompanying scientific literature, and onthe assessments of EPA and FDA, APHIS has concluded that SyngentaMIR162 com would have no significant impacts on human oranimal health.3. Unique characteristics of the geographic area such asproximity to historic or cultural resources, park lands, prime farmlands, wetlands, wildandscenic rivers,

or ecologically critical areas. There are no unique characteristics ofgeographic area such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas that would be significantly affected. MIR162 will onlybe grown in areas suitable for the production ofcom and those historically used for comproduction. There is

no significant difference inperformance or agricultural practices for growing MIR162 comcompared to other comvarieties (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 of the human environment are likely
to be highly controversial. The effects onthe quality ofthe human environment are not highly controversial. Although there is some opposition to the granting ofnonregulated status to MIR162 com, this action is not highly controversial in terms ofsize, nature or effect. Other than objections to all genetically engineered crops, the public
comments did not register any specific factual concerns with the dataprovided APHIS for this crop or its analysis, both ofwhich were presented in the EA. 5. The degree to which thepossible effects on the human environment are highly uncertain or involve unique or unknown risks. Based on the analysis documented in the EA, the effects onthe human environment would not be significant. The effects ofthe proposed nonregulated
status for MIR162 are not highly uncertain and do not involve unique orunknown risks. As described in Chapters 4 and 6 ofthe EA, well established management practices, production controls, and productionpractices (GE, conventional, and organic) are currently being used in comproduction systems in the US. Therefore, it is reasonable to assume that farmers, who produce conventional
com, MIR162 com, orproduce comusing organic methods, will continue to use these reasonable, commonly accepted best management practices for their chosen system and varieties for agricultural comproduction. Additionally, 85% ofthe

com acreage in the U.S. is planted to GE varieties. Ofthe total com acres planted in 2009, 63% were GE Bt orBt-stacked comvarieties (USDA-NASS 2009a). The availability ofMIR162 com would offer growers and manufacturers another choice ofcomresistant to insects in addition to the options already available. 6. The degree to which the action may establish aprecedent for future actions with significant effects or represents a decision inprinciple about afuture consideration. Theproposed action would not establish aprecedent for future actions with significant effects or represent a decision in principle about a future decision. Similarto pastpetitions for nonregulated status (USDA-APHIS 2010), APHIS decision on the regulatory status ofMIR162 com will be based upon information provided in the petition submitted bythe applicant. APHIS regulations at 7 CFR part 340, regulate the introduction (importation, interstate movement, or release into the environment) ofcertain GE organisms and products. A person may petition the agency to evaluate submitted data and determine that aparticularregulated article is unlikely to pose a plant pest risk, and, therefore, should no longerbe regulated, under 7 CFR § 340.6 "Petition for Determination of Nonregulated Status." After receipt ofapetition, 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 of7 CFRpart 340. Each petition that APHIS receives undergoes this independent review to determine ifthe regulated article poses aplantpest risk. 7. Whether the action is related to otheractions with individually insignificant but cumulativelysignificant impacts. No significant cumulative effects were identified through this assessment. The EA evaluated the potential cumulative impacts ofgranting nonregulated status to MIR162 com including the effects on comproduction, genetic purity ofcom germplasm, genetic diversity ofcom, insect resistance, threatened and endangered species and biodiversity. A cumulative effects analysis is included inChapter 6 ofthe EA. Ifgranted nonregulated status, MIR162 com maybe stacked (combined) with conventional varieties or othernonregulated GE com varieties bytraditional breeding techniques, resulting in comthat, for example, may also be resistant to herbicides or other insects. EPA has approved the conditional registration ofMIR162 stacked comhybrids. As presented in the EA, onJuly 23, 2008 EPA announced receipt ofa petition from Syngentato conditionallyregister three pesticideproducts containing the new active ingredient Vip3Aa20 and the genetic material necessary for its production in com (73 FR 42799-42801). These pesticideproducts included MIR162 and the two comhybrids Btl1 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 byAPHIS and registered as plant-incorporated protectants byEPA). On April 30, 2009, EPA announced the approval ofthese conditionalregistrations 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 companyplans and market demands playa significantrole in those business decisions. Postulating and predicting any and all potential combinations ofstacked varieties that couldbe created using both deregulated GE com varieties and also non-GE comvarieties is too hypothetical and purely speCUlative. 8. The degree to which the action may adversely affectdistricts, sites, highways, structures, or objects listed in or eligible for listing in theNationalRegisterof Historic Places ormay cause loss ordestruction of significantscientific, cultural,

orhistorical resources. MIR162 comwould 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 ordestruction ofsignificant scientific, cultural, orhistorical resources. Granting nonregulated status to MIR162 com will not cause an increase in agricultural acreage devoted to comproduction, orto

acres devoted to GE com cultivation. MIR162 comwill also not change future cultivation areas for com production in the U.S. This com varietydoes not express new agronomic traits orresistance traits useful against a geographicallylimiting insect species. Consequently, growers will not likelyplant new land beyond that currently or historically used for corn production ifthis trait is made commercially available. 9. The degree to which the action may adversely affect an endangered orthreatened species orits habitat that has been determined to be critical under the EndangeredSpeciesAct of 1973. 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 of Federal, State, or local law or requirements imposed for theprotection of the environment. Theproposed action would bein 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 wouldbe carried out in accordance with 7 CFRpart 340. MIR162 corn has successfully completed the consultationprocess with the FDA concerning food and feed safety (Appendix 1 ofthe EA). MIR162 corn expresses a genetically engineeredpesticide 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 otherFederal, state, or local permits that are needed prior to the implementation ofthis action. A list ofthe current status ofU.S. and international approvals is found inTable 1ofthis Decision Document.

NEPA Decision and Rationale I have carefully reviewed the EAprepared for this NEPA determination and the input from the public involvementprocess. Ibelieve that the issues identified inthe EA are best addressed by selecting Alternative B - Grant nonregulated status to Syngenta MIR162 corn, "in whole".

As stated in the CEQregulations, "the agency's preferred alternative is the alternative which the agencybelieves 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 ofa number of environmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative B is selectedbecause (1) it allows APHIS to fulfill its statutorymission to protect America's agriculture and environment using a dynamic and science-based regulatory framework that allows for the safe development and use ofgenetically 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 commentsidentified 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 BiotechnologyRegulatory Services Animal and Plant Health Inspection Services U.S. Department ofAgriculture

Literature Cited:

EPA 2008. Bacillus thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic Material Necessary for Its Production (via Elements ofVectorpNOV1300) 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 CrylAbDelta-EndotoxinProtein and the Genetic Material Necessary for Its Production (via Elements ofVector 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 ofVector 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 CrylAbDelta-EndotoxinProtein and the Genetic Material Necessary for Its Production (via Elements ofVectorpZOl502) in Event BtlI Com (OECD Unique Identifier: SYN-BT011-1)(006444) & Bacillus thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic Material Necessary for Its Production (via Elements ofVector pNOV1300) inEvent MIRl62 Maize (OECD Unique Identifier: SYN-IRI62-4)(006599) & Modified Cry3A Protein and the Genetic Material Necessary for Its Production (via Elements ofVector pZM26) in Event MIR604 Com(OECD Unique Identifier: SYN-IR604­ 5)(006509) Fact Sheet. US Environmental Protection Agency. http://www

.epa.govIoppbppdllbiopesticides/ingredients/factsheetslfactsheet_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 3/15/10).

USDA-APHIS (2010). Petitions ofNomegulated Status Granted orPendingbyAPHIS

as ofFebruary 2, 2010. USDA Animal and Plant Health Inspection Service. http://www.aphis.usda.gov/brs/not reg.html

USDA-APHIS (2009) Plant Pest Risk Analysis for SyngentaMIR162 com. USDA, APHIS, Biotechnology Regulatory Service. Riverdale, MD http://www.aphis.usda.gov/brs/not reg.html

USDA-NASS. (2009) Census ofAgriculture. Table 26. Field Crops 2007 and 2002. http://www.agcensus.usda.gov/Publications!2007!Full Report/Volume 1, Chapte r 2 US State Level/st99 2 026 026.pdf

USDA-NASS. (2009a). Adoption ofGenetically Engineered Crops in the U.S.: Com Varieties. Genetically engineered (GE) com varieties by State and United States, 2000-2009. USDANational Agricultural Statistics Service. http://www.ers.usda.gov/data/BiotechCrops/ExtentofAdoptionTablel.htm