### NATIONALENVIRONMENTALPOLICYACT DECISION AND FINDING OFNO SIGNIFICANT IMPACT

Monsanto Company Event MON 87701 Soybean

United States Department ofAgriculture Animal and PlantHealth Inspection Service Biotechnology Regulatory Services

TheUnited States Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has developed this decision document to complywith the requirements ofthe National Environmental PolicyAct (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ)"regulations implementingNEPA, and the USDA APHIS' NEPA implementing regulations and procedures, This NEPA decision document, a Finding ofNo Significant Impact (FONSI), sets forth APHIS' NEPA decision and its rationale. Comments from the public involvementprocess were evaluated and considered in developing this NEPA decision.

In accordance with APHls procedures implementingNEPA (7 CFRpart 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated status ofa petition request (APHIS Number 09-082-0Ip) byMonsanto Company (Monsanto) for their genetically engineered EventMON 87701 Soybean (hereafter referred to as MON 87701 Soybean) that expresses a Cry1Ac protein to protect soybean plants from lepidopteran insect damage. This EA has been prepared in orderto specificallyevaluate the effects on the quality of the human environmentl 

### thatmay result from approving the petition seekingnonregulated status for MON 87701 Soybean. The EA assesses alternatives to a determination ofnonregulated status ofMON 87701 Soybean and analyzes the potential environmental and social effects that result from the proposed action and the alternatives.

Since releasing the draft EA for public comment on June 28, 2011, EPA approved a label change that allows MON 87701 Soybean to be grown in Illinois, Arkansas, and the Commonwealth of Puerto Rico (U.S. EPA, 2011). This label change onlymodified the locations where MON 87701 Soybean breeding and seed multiplication activities can be carried out under the EPA label and did not expand the total acreage approved for planting. Total EPA approved acreage remains at 15,000 acres. Relevant information and environmental impacts associated with this EPA label change has been incorporated into the final EA and this NEPA decision document.
Regulatory Authority "ProtectingAmerican agriculture" is the basic charge ofAPHIS, APHIS provides leadership in ensuring the health and care ofplants and animals. The agency improves agricultural productivityand competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural production (conventional, organic, orthe use of

I Under NEPA regulations, the "human environment" includes "the natural and physical environment and the relationship ofpeop\e with that environment" (40 CFR §50S.14).genetically engineered (GE) varieties) can provide benefits to the environment, consumers, and farm income.

Since 1986, the United States governmenthas regulated genetically engineered (GE) organisms pursuantto a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) (51 FR 23302,57 FR 22984). The Coordinated Framework, published by the Office ofScience and Technology Policy, describes the comprehensive federal regulatorypolicy for ensuring the safety ofbiotechnologyresearch and products and explains how federal agencies will use existing Federal statutes in a mannerto

ensure public health and environmental safetywhile maintaining regulatory flexibility to avoid impeding the growth ofthe biotechnologyindustry. The Coordinated Frameworkis based on several important guidingprinciples: (1) agencies should define those transgenic organisms subject to review to the extent permittedbytheirrespective statutoryauthorities; (2) agencies are required to focus on the characteristics and risks ofthe biotechnologyproduct, notthe process by which it is created; (3) agencies are mandated to exercise oversight ofGE organisms only when there is evidence of"unreasonable"risk.

The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA's APHIS, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

APHIS is responsible for regulating GE organisms andplants under the plant pest provision in the Plant Protection Act of2000, as amended (7 USC § 7701 et seq.) to ensure that they do not pose a plant pestrisk to the environment.

The FDA regulates GE organisms underthe authority ofthe Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling ofall plantderived foods and feeds, including those that are genetically engineered. To help developers of food and feed derived from GE crops comply with their obligations underFederal food safety laws, FDA encourages them to participate in 

### a voluntary consultation process. All food and feed derived from GE crops currentlyon the market in the United States have successfully completed this consultation process. The FDA policy statement concerning regulation ofproducts derived from newplant varieties, including those genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR22984-23005). Underthis policy, FDA uses what is termed a consultation process to ensure that human food and animal feed safetyissues orotherregulatory issues (e.g., labeling) are resolved priorto commercial distribution ofbioengineered food.

The EPAregulates plant-incorporated protectants underthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues ofpesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control organisms underthe Toxic Substances Control Act (TSCA). The EPA is responsible for regUlating the sale, distribution, and use ofpesticides, including pesticides that are produced by

an organism through techniques ofmodern biotechnology.
Regulated Organisms

2TheAPHIS BiotechnologyRegulatory Service's (BRS) mission is to protect America's agriculture and environmentusing a dynamic and science-based regulatory framework that allows for the safe development and use ofGE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plant pest provisions ofthe Plant Protection Act orto the regulatoryrequirements of7 CFRpart 340 when APHIS determines that it is unlikelyto pose a plantpestrisk. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, orvectoragent used in engineering the organismbelongs to one ofthe taxa listed in the regulation (7 CFR 340.2) and is also considered

a plantpest. A GE organism is also regulated under Part 340 when APHIS has reason to believe thatthe GE organism maybe a plantpest orAPHIS does not have information to determine if the GE organism is unlikely to pose a plantpestrisk.

A person maypetition the agency that a particularregulated article is unlikelyto pose a plant pestrisk, and, therefore, is no longer regulated under the plantpest provisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. Thepetitioner is required to provide information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whetherthe regulated article is unlikelyto present a greaterplant pestrisk than the unmodified organism. A GE organism is no longer subject to the regulatoryrequirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk.



### APHIS' Response to Petition for Nonregulated Status Underthe authority ofthe plantpestprovisions ofthe Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the safe development and use ofGE organisms. As required by7 CFR 340.6, APHIS must respond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as MON 87701 Soybean. When a petition for nonregulated status is submitted, APHIS mustmake a determination ifthe GE organism is unlikelyto pose aplantpestrisk. IfAPHIS determines based on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organism is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pestprovisions ofthe Plant Protection Act and 7 CFRpart 340.

Monsanto has submitted a petition (APHIS Number09-082-01p) to APHIS seeking a determination that their genetically engineered MON 87701 Soybean is unlikelyto pose a plant pest risk and, therefore, should no longerbe a regulated article underregulations at 7 CFR Part 340.



### MON 87701 Soybean MON 87701 Soybean expresses an insecticidal protein, CrylAc, and was developed for the South American soybean market. In this region, the lepidopteran pest, Epinotia aporema, causes
severe economic damage through eating ofsoybean plants (Higley and Boethel, 1994). Because itbores into the stem, larvae are protected from insecticidal sprays. Control ofthese insects requires high levels ofsystemic insecticide treatment. To be effective, the application ofthese

3insecticides needs to be carefully timed (Higley and Boethel, 1994). Cry1Ac is a lepidopteranspecific (e.g., E. aporema) insecticide derived from the soil bacterium, Bacillus thuringiensis (Bt). This protein does not affect other orders ofinsects or animals (van Frankenhuyzen, 2009). Although initially developed for the South American soybean market, US. growers may eventually adopt MON 87701 Soybean for commercial production ifMonsanto obtains appropriate registrations from the EPA (Monsanto, 2010). Currently, MON 87701 Soybean has onlyreceived EPA approval for breeding and seed multiplication activities for a total of 15,000

acres in Georgia, South Carolina, North Carolina, Virginia, Maryland, Illinois, Arkansas, and the Commonwealth ofPuerto Rico with no more than 1,000 acres per county (municipio) per year except for Illinois and Arkansas where only 300 acres can be grown in each state (US. EPA, 2011). This type ofEPA registration precludes commercial sale ofMON 87701 Soybean in the US.

Coordinated Framework Review FoodandDrugAdministration MON 87701 Soybean is within the scope ofthe FDApolicy statement concerning regulation of products derived from new plant varieties, including those produced through genetic engineering. Monsanto initiated the consultation process with FDA for the commercial distribution ofMaN 87701 Soybean and submitted a safety and nutritional assessment offood and feed derived from MON 87701 Soybean to the FDA on May 28, 2009 (BNF No. 000119) (FDA, 201Ob). FDA evaluated the submission and responded to the developer by letter on August 18,2010 (FDA, 2010a). Based on the information Monsanto submitted, and as of August 5, 2010, FDA has no further questions regarding MaN 87701 Soybean.

Environmental ProtectionAgency The EPA regulates plant-incorporated protectants (PIPs) under FIFRA (7 US.c. 136 etseq.) and certain biological control organisms under TSCA (15 U.S.C. 53 et seq.). Beforeplanting a crop containing a PIP, a companymust seek anexperimental use permit from EPA. Commercial production ofcrops containing PIPs for purposes ofseed increases and sale requires a FIFRA Section 3 registration with EPA. In September 2010, Monsanto received EPA registration for MON 87701 Soybean for seed increase, only, with the following terms and conditions (US-EPA, 2010):
1) The subject registration will automatically expire on midnight September 30, 2013.
2) The subject registration is limited to seed increase and to a total of 15,000 acres per year in the States ofGeorgia, South Carolina, North Carolina, Virginia, and Maryland with no
more than 1,000 acres percountyper year.
3) Monsanto must submit IRM monitoring andremedial action plans to EPA for approval by January 31, 2011, and reports on such annually by August 31s1.
4) Monsanto mustprovide EPA annual reports on the acreage and States where MON 87701 Soybean has been grown by January 31st.

5) While exposure is expected to be very low in aquatic habitats, and effects on freshwater invertebrates are not expected, Monsanto must do the following to extend the expiration

4date ofthis registration. Namely, Monsanto must submit a 7-10 day freshwater invertebrate toxicity study orotherwise adequately address aquatic invertebrate issues raised byRosi- Marshall, et al. in 2007 regarding the leafshredding (caddis fly) trichopteran, Lepidostoma liba (US-EPA, 2010).

On June 9, 2011 EPA approved a label change that allows MON 87701 Soybean to be grown in Illinois, Arkansas, and the Commonwealth ofPuerto Rico. The label permits up to 300

acres in Arkansas orIllinois, and up to 100 acres permunicipio in Puerto Rico. There is still

a limit oftotal 15,000 acres in the allowed areas (U.S. EPA, 2011).
Scope oftheEnvironmental Analysis Although a determination ofnonregulated status ofMON 87701 Soybean would allow for new plantings ofMON 87701 Soybean to occuranywhere in the U.S., APHIS primarilyfocused the environmental analysis to those geographic areas where MON 8770I Soybean could be grown. MON 87701 Soybean is regulated in part by FIFRA, due to characteri.zatioh ofthe CrylAc protein product as a pesticide by the EPA. Currently, MON 87701 Soybean is registered bythe EPA for breeding and seed increase activities in the Atlantic Coastal states ofGeorgia, South Carolina, North Carolina, Virginia, and Maryland (US-EPA, 2010) as well as Illinois, Arkansas, and the Commonwealth ofPuerto Rico (U.S. EPA, 2011). Thisregistration is limited to 15,000 total acres in the specified states and Puerto Rico, with production limited to 1,000 acres per county (municipio) except in Arkansas and Illinois were production is limited to 300 acres for each state. Commercial sale ofMON 87701 Soybean in the U.S. is not allowed under this type ofEPA registration. Thus, the scope ofanalysis ofthe EA focuses on the cultivation ofMON 87701 Soybean for seed production in Georgia, South Carolina, North Carolina, Virginia, and Maryland (US-EPA, 2010) as well as Illinois, Arkansas, and the Commonwealth ofPuerto Rico (U.S. EPA, 2011).

Public Involvement On June 28, 2011, APHIS published a notice in theFederal Register (76 FR 37770-37771, Docketno. APHIS-2011-0038) announcing the availability ofthe Monsanto petition, and the APHIS PPRA and draft EA for a 60-daypublic review and commentperiod. Comments were required to be received on orbefore August 29, 2011. All comments were carefully analyzed to identify new issues, alternatives, or information. A total offour comments were received from individuals during the comment period. Commentdocuments may be viewed at http://wvvw.regulations.govI#!searchResuI ts;rpp=1 O:po=O;s=aphis-2011-0038. Two public comments referenced a different soybean line; these were outside the scope oftheaction being considered bythe Agency in this docket. These comments werereferred to the docket ofthe referenced soybean line. One comment expressed opposition to a determination ofnonregulated status ofMON 87701 Soybean, but did not change the analysis provided in the PPRAordraft EA. This individual did not mention a specific disagreement with APHIS' analyses ofMON 87701 Soybean detailed in the EA orthe PPRA(USDA-APHIS, 20lla); rather, the comment made general statements about unknowns associated with the use ofgeneticallymodified organisms (GMOs) or GE crops. The second comment suggests that APHIS should analyze the impacts ofMON 87701 Soybean on bees and groundwater. Impacts to non-target insects and impacts on water are both addressed in the EA. The author ofthe comment did not offer any
new information ormention any specific disagreement with APHIS' analyses ofMON 87701 Soybean detailed in the EA orthe PPRA(USDA-APHIS, 20l1a). No new issues, alternatives or

5substantive new information were identified in any ofthe comments received by APHIS. Responses to substantive comments are included as an attachment to this Finding ofNo Significant Impact.
Major Issues Addressed in the EA The issues considered in the EA were developed based on APHIS' determination that certain genetically engineered organisms are no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340, and for this particular EA, the specific petition seeking a determination ofnonregulated status ofMON 87701 Soybean. Issues discussed in the EA were developed byconsideringpublic concerns as well as issues raised in public comments submitted for otherenvironmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well as those issues that have been raised by various stakeholders. These issues, including those regarding the agricultural production ofsoybean using various production methods, and the environmental and food/feed safety ofgenetically engineeredplants were addressed to analyze the potential environmental impacts ofMON 87701 Soybean.

The EA describes the alternatives considered and evaluated using the identified issues. The following issues were identified as important to the scope ofthe analysis (40 CFR 1508.25):
Agricultural Production Considerations:

• Acreage and Areas ofSoybean Production

• Agronomic/Cropping Practices

• Soybean Seed Production

• Organic Soybean Production
Environmental Considerations: 

## • Water Resources 

## • Soil


## • Air Quality 

## • Climate Change 

## • Animals 

## • Plants 

## • Gene Flow


## • Microorganisms 

## • Biological Diversity
Human Health Considerations:

• Public Health

• Worker Safety Livestock Health Considerations:

• Livestock Health! Animal Feed Socioeconomic Considerations:

• Domestic Economic Environment

• Organic Farming

• Trade Economic Environment

6Alternatives that werefully analyzed The EA analyzes the potential environmental consequences ofa determination ofnonregulated status ofMON 87701 Soybean. To respond favorably to a petition for nonregulated status, APHIS must determine that MON 87701 Soybean is unlikely to pose a plantpestrisk. Based

on its Plant Pest Risk Assessment (USDA-APHIS, 2011b), APHIS has concluded that MON 87701 Soybean is unlikely to pose a plantpestrisk. Therefore, APHIS must determine that MON 87701 Soybean is no longer subject to 7 CFRpart 340 orthe plantpestprovisions ofthe PlantProtection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination ofnonregulated status ofMON 87701 Soybean. APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section ofthe EA.

No Action: Continuation as a Regulated Article Underthe No Action Alternative, APHIS would deny the petition. MON 87701 Soybean and progeny derived from MON 87701 Soybean would continue to be regulated articles under the regulations at 7 CFRpart 340. Permits issued ornotifications acknowledged byAPHIS would still berequired for introductions ofMON 87701 Soybean and measures to ensure physical and reproductive confinementwould continue to be implemented. APHIS might choose this alternative ifthere were insufficient evidence to demonstrate the lack ofplantpestrisk from the unconfined cultivation ofMON 87701 Soybean.

This alternative is not the Preferred Alternative because APHIS has concluded through a Plant Pest Risk Assessment that MON 87701 Soybean is unlikelyto pose a plant pestrisk (USDAAPHIS, 2011a). Choosing this alternative would not satisfy the purpose and need ofmaking a determination ofplant pestrisk status and responding to the petition for nonregulated status

..
PreferredAlternative: Determination that MON 87701 Soybean is No Longer a Regulated Article Underthis alternative, MON 87701 Soybean and progeny derived from them would no longer be regulated articles underthe regulations at 7 CFRpart 340. MON 87701 Soybean is unlikely to pose a plantpestrisk (USDA-APHIS, 2011a). Permits issued ornotifications acknowledged by APHIS would no longerberequired for introductions ofMON 87701 Soybean and progeny derived from this event. This alternative best meetsthe purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFRpart 340 andthe agency's authority under the plant pest provisions ofthe Plant Protection Act. Because the agencyhas concludedthat MON 87701 Soybean is unlikelyto pose a plantpestrisk, a determination ofnonregulated status ofMON 87701 Soybean is a response that is consistent with theplantpestprovisions ofthe PPA, the regulations codified in 7 CFRpart 340, and the biotechnologyregulatory policies in the Coordinated Framework. Underthis alternative, growers mayhave future access to MON 87701 Soybean and progeny derived from this event if the developer decides to commercialize MON 87701 Soybean.

Alternatives Considered but Rejected from Further Consideration APHIS assembled a list ofalternatives that mightbe considered for MON 87701 Soybean. The agency evaluated these alternatives, in light ofthe agency's authority underthe plantpest provisions ofthe Plant Protection Act, and the regulations at 7 CFRpart 340, with respect to environmental safety, efficacy, and practicality to identify which alternatives would be further

7considered for MON 87701 Soybean. Based on this evaluation, APHIS rejected several alternatives. These alternatives are discussed briefly below along with the specific reasons for rejecting each.



### ProhibitanyMON87701 Soybean/rom being released In response to public comments that stated a preference that no GE organisms enterthe marketplace, APHIS considered prohibiting the release ofMON 87701 Soybean, including denying any permits associated with the field testing. APHIS determined that this alternative is not appropriate given that APHIS has concluded that MON 87701 Soybean is unlikely to pose a plant pest risk (USDA-APHIS, 20Ila).

In enacting the Plant ProtectionAct, Congress found that

[D]ecisions affecting imports, exports, and interstate movement ofproducts regulated under [the Plant Protection Act] shall bebased on sound science

... § 402(4).

On March 11, 2011, in a Memorandum for the Heads ofExecutive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemerging technologies (such as genetic engineering) at the agency level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principle, among others, to the extent permitted by law, when regulating emerging technologies:

"[D]ecisions should bebased on the best reasonably obtainable scientific, technical, economic, and otherinformation, within the boundaries ofthe authorities and mandates ofeach agency"

Based on ourPlant Pest Risk Assessment (USDA-APHIS, 2011a) and the scientific data evaluated therein, APHIS has concluded that MON 87701 Soybean is unlikely to pose a plant pestrisk. Accordingly, there is no basis in science for prohibiting therelease ofMON 87701 Soybean.


### Approvethepetition inpart The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole

or in part." For example, a determination ofnonregulated status in part may be appropriate if there is aplant pest risk associated with some, but not all tines described in a petition. Because APHIS has concludedthat MON 87701 Soybean is unlikely to pose a plantpestrisk, there is no regulatory basis underthe plant pest provisions ofthe Plant Protection Act for considering approval ofthe petition only in part.

Isolation distance between lYION87701 Soybean andnon-GE soybean andgeographical restrictions In response to public concerns ofgene movement between GE and non-GE plants, APHIS considered requiring an isolation distance separating MON 87701 Soybean from conventional or specialty soybean production. However, because APHIS has concluded that MON 87701 Soybean is unlikely to pose a plant pest risk (USDA-APHIS, 20lla), an alternative based on

8requiring isolation distances would be inconsistent with the statutoryauthority underthe plant pestprovisions ofthe Plant Protection Act and regulations in 7 CFRpart 340.

APHIS also considered geographicallyrestricting the production ofMON 87701 Soybean to those areas where MON 87701 Soybean were allowed to be grown byEPA. EPA regulates MON 87701 Soybeanunder FIFRA. However, as presented in APHIS' plant pestrisk assessment for MON 8770I Soybean, there are no geographic differences associated with any identifiableplantpestrisks for MON 87701 Soybean (USDA-APHIS, 201Ia). This alternative

was rejected and not analyzed in detail because APHIS has concluded that MON 87701 Soybean does notpose a plantpest risk, and will not exhibit a greaterplantpest risk in any geographically restricted area. Therefore, such an alternative would not be consistent with APHIS' statutory authorityunder the plantpest provisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnologyregulatorypolicies embodied in the Coordinated Framework.

Based on the foregoing, the imposition ofisolation distances orgeographic restrictions would not meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFRpart 340 and the agency's authority underthe plantpest provisions ofthe Plant Protection Act.


### Requiremento/TestingForMON87701 Soybean During the commentperiods for otherpetitions for nonregulated status, some commenters requested USDA to require and provide testing to identifyGE products in non-GE production systems. APHIS notes there are no nationally-established regulations involving testing, criteria, or limits ofGE material in non-GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, because MON 87701 Soybean does not pose a plantpest risk (USDA-APHIS, 201Ia), the imposition ofanytype oftesting requirements is inconsistent with the plantpestprovisions ofthe PlantProtection Act, the regulations at 7 CFRpart 340 and the biotechnologyregulatorypolicies embodied in the Coordinated Framework. Therefore, imposing such a requirement fDr MON 87701 Soybean would not meet APHIS' purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.

Environmental Consequences ofAPHIS' Selected Action The EA contains a full analysis ofthe alternatives to which we refer the reader for specific details. The following table briefly summarizes theresults for each ofthe issues fully analyzed in the Environmental Consequences section ofthe EA.

•Management Practices

Meets Purpose and Need and ectives Yes Unlikely to pose a • Satisfied through use of Satisfied risk plant pest risk regulated field trials assessment DA-APHIS 2011

9Alternative B: Determination 

# I Attribute/Measure Alternative A: No Action ofNonregulated Status

.... . 

### .. ' Unlikely to influence Acreage and Areas of current trends in production Unchanged from No Soybean Production I regions or acreage of Action Alternative

· soybean planted

Cropping practices will I remain the same as current Unchanged from No Agronomic Practices practices for commercial Action Alternative soybean seed production

Pesticide Use



## I

i Pesticide use unlikely to change. May see a decrease in insecticide use on MON 8770I soy

- will depend on Unchanged from No type ofinsect pest. Due to Action Alternative limited acreage will not change national orregional pesticide use. Soybean Seed Unchanged Unchanged i Production I Organic Soybean Unchanged Unchanged

. Production

Environment MON 87701 is not expected 

### I Unchanged Land Use to have any effect on land

use MON 87701 is not expected Unchanged WaterResources

· to have any effect on water MON 8770I is not expected Unchanged Soil to have any effect on soil MON 87701 is not expected Air Quality Unchanged I quality 

## I MON 87701 is not expected to have any effect on air

i I Climate Change to have any effect on climate i change Unchanged

MON 87701 is not expected to have any effect on vertebrate animals or most invertebrate animals. MON
Animals 87701 is toxic to certain lepidopteran insects. Those that feed directly on MON 87701 soybeans would be Unchanged from the No Action Alternative

· expected to die or have
ThIS IS i

lOPlants

Gene Movement •unlikely to affect insect

. populations due to the

•limited number acres and the

patchy distribution ofthese fields on the landsca e. MON 87701 is not expected to have any effect on plants
MON 87701 is not expected to have any effect on vertical

orhorizontal gene flow. Unchanged

Unchanged

Soil Microorganisms MON 87701 is notexpected to have any effect on soil ' Unchanged microorganisms.
MON 87701 is notexpected Biological Diversity to have any effecton Unchanged biological diversity.



### uman and Animal Health

Risk to Human Health

Risk to Animal Feed



### Socioeconomic

Domestic Economic Environment
Trade Economic Environment MON 8770I does nothave adverse human health effects MON 87701 does change the nutritional qualities ofanimal feed.

Unchanged May increase soybean seed for planting exports to some markets 

### royals FDA completed consultations, EPA U.S. tolerance exemptions and conditional pesticide

re istrations anted South America Brazil 

### Com liance with Other Laws

CW A, CAA, EOs Fully compliant Unchanged

Unchanged

Unchanged May increase soybean seed for planting exports to

some markets

FDA completed consultations, EPA tolerance exemptions and conditional pesticide

re

.strations nted Brazil

Fully compliant


### Finding ofNo Significant Impact The analysis in the EA indicates thatthere will notbe a significant impact, individuallyor cumulatively, on the quality ofthe human environment as a result ofthis proposed action. I

11agree with this conclusion and therefore find that an EIS need not be prepared. 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 soybean production systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commodity markets. MON 87701 Soybean is regulated in part byFIFRA, due to characterization ofthe Cry1Ac protein product as a pesticide bythe EPA. Currently, MON 87701 Soybean is registeredbythe EPA for breeding and seed increase activities in the Atlantic Coastal states ofGeorgia, South Carolina, North Carolina, Virginia, and Maryland (US-EPA, 2010) and Illinois, Arkansas, and the Commonwealth ofPuerto Rico (U.S. EPA, 2011). This registration is limitedto 15,000 total acres in the specified states and Puerto Rico. Production is limitedto 1,000 acres per county ormunicipio, except in Illinois and Arkansas were it is limited to 300 acres in each state. Commercial sale ofMON 87701 Soybean in the U.S. is not allowed underthis type ofEPA registration. According to the petition, the intended use ofthis soybean seed is for export to South American markets (Monsanto, 2010). However, the petition does mention the potential for future plans ofMonsanto to expand that market into the U.S. (Monsanto, 2010). Ifapprovedbythe EPA for commercial sale, MON 87701 Soybean cultivation would notbe restricted in the U.S. and could be expanded from 15,000 acres to more than 75 million acres, assuming that MON 87701 Soybean is broadly adopted throughout the U.S (USDA-1\ASS,2010). Therefore, the potential future expansion ofMON 87701Soybean acreage in the U.S. is considered as part ofthe cumulative impacts analysis. However, potential adoption ofMON 87701 Soybean by soybean growers in the U.S. is limited. MON 87701 Soybean expresses a Cry1Ac protein to protect soybeanplants from lepidopteran insect damage. Currently, insecticides are used on only about 16% ofthe soybean acres planted in the U.S. (USDA-NASS, 2007). Only a portion ofthese acres are managed for lepidopteran insectpests. The states that might adoptMON 87701 Soybean due to lepidopteran insect pressure include Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, MissoUli, North Carolina, South Carolina, Tennessee, Texas, and Virginia (Leonard, 2011). Together these states account for about 15 percent ofthe total soybean acres ofthe U.S. Itis unlikely that all ofthese

acres would be converted to MON 87701 Soybean, because insect pressure is not unifornl in all

areas ofa state. Therefore, it is likely that ifMON 87701 Soybean were to become available in the U.S. in the future, the adoption rate would be less than 15 percent ofthe total U.S. soybean production. The adoption rate would be driven by the price ofMON 87701 Soybean seed, the cost ofinsecticides, the likelihood ofdamage levels from lepidopteran pcsts that reach economic thresholds, and the price ofsoybeans.

A determination ofnonregulated status ofMON 87701 Soybean is not expected to directly

cause an increase in agricultural acreage devoted to soybean production, orthose soybean

acres devoted to GE soybean cultivation. The availability ofMON 87701 Soybean will not change cultivation areas for soybean production in the U.S. and there are no anticipated changes to the availability ofGE and non-GE soybean varieties on the market. Due to planting restrictions defined bythe EPA seed increase registration, cultivation ofMON 87701 Soybean would remain a small percentage oftotal soybean cultivation area and would have no impact on current and projected land use patterns in the Atlantic Coastal states and Illinois, Arkansas, and

12

### the Commonwealth ofPuerto Rico. Cultivation ofMON 87701 Soybean for seed increase activities on 15,000 acres in the allowed states would represent 0.09 percent ofthe approximate 15.5 million soybean acres planted in this region (USDA-NASS, 2011). Additionally, neither the EPA approval ofMON 87701 Soybean under a commercial use registration northe crossing ofMON 87701 Soybean with an herbicide-resistant soybean variety is likely to expand the range ofsoybeans or change land use patterns beyond what is already observed for soybean cultivation in the U.S. MON 87701 Soybean is still a domesticated crop that cannot be cultivated outside

areas ofcurrent agronomic management due to agricultural input requirements. GE soybeans currently are planted on the majority ofsoybean acres in the U.S. (93% ofacreage in 2010) (USDA-ERS, 20lOa). All these GE soybean varieties are herbicide resistant. As a result, the use ofherbicide resistant soybean systems is the most common method in the U.S. for management ofweeds in soybean fields. Based on this information, it is reasonable to foresee that MON 87701 Soybean would be combined with one ormore ofthese herbicide resistant events that are
no longer subject to the plantpestprovisions ofthe PlantProtection Act and 7 CFRpart 340in the future (USDA-APHIS, 2011b).
Althougha determination ofnonregulated status ofMON 87701 Soybean would allow for new plantings ofMON 87701 Soybean to occuranywhere in the U.S., APHIS primarily focused the environmental analysis to those geographic areas where MON 87701 Soybeancould be 

### grown. A determination ofnonregulated status ofMON 87701 Soybean is not expected to increase soybean production, eitherbyits availability alone oraccompanied byother factors, orcause an increase in overall GE soybean acreage. 

### Intensity

- Intensity is a measure ofthe degree or severity ofan impact based upon the ten factors. The following factors were used as a basis for this decision:



### 1. Impacts that may be both benefiCialandadverse. A determination ofnonregulated status ofMON 87701 Soybean will have no significant environmental impact in relation to the availability ofGE, conventional or organic soybean varieties. As discussed in Chapters 4 and 5 ofthe EA, a determination of nonregulated status ofMON 8770I Soybean is notexpected to directly cause an increase in agricultural acreage devoted to soybean production, orthose soybean acres devoted to GE soybean cultivation. The availability ofMON 87701 Soybean will not change cultivation areas for soybean production in the U.S. and there are no anticipated changes to the availability ofGE and non-GE soybean varieties on the market. A determination ofnonregulated status ofMON 8770I Soybeancould add another GE soybeanvariety to the conventional soybean market and is not expected to change the market demands for GE soybean or soybean produced using organic methods. GE and organic soybeans are planted on about 93% and 0.13% ofsoybean acres in the U.S., respectively (USDAERS,20lOa). All ofthe GE soybean varieties are herbicide resistant. As a result, the use ofherbicide resistant soybean systems is the mostcommon method in the U.S. for management ofweeds in soybean fields. Based onthis information, itis reasonable to foresee thatMON 87701 Soybean would be combined with one ormore ofthese herbicide resistant events that are no longer subjectto the plantpestprovisions ofthe PlantProtection Actand 7 CFRpart 340in the future (USDA-APHIS, 2011b). Currently, MON 87701 Soybean is registered bythe EPA for breeding and seed increase activities in the states ofGeorgia, South Carolina, North Carolina, Virginia, and

13Maryland (US-EPA, 2010) as well as Illinois, Arkansas, and the Commonwealth of Puerto Rico. This registration is limited to 15,000 total acres in the specified states (and Puerto Rico), with production limited to 1,000 acres per county (municipio) except for Arkansas and lllinois where it is limited to 300 acres in each state (U.S. EPA, 2011). Relative to the approximate 5.5 million acres ofsoybeans harvested in these seven states, MaN 87701 Soybean mayrepresent up to 0.09 percent oftotal soybean acreage. The majority ofthe remaining soybeans (about 90 percent) are nonregulated GE soybeans (USDA-ERS, 201Oa), with organic soybean production in these six states representing less than 2 percent oftotal organic soybean production. Illinois has about 6.5 percent of the national organic soybean production (see Table 3, Section 2.1.4). However, acreage is limited to 300 acres in the whole state, orless than 3/1000th of 1 percent ofthe soybeans grown in this state. On a broader scale, ifMON 87701 Soybean were to be granted a commercial use registration by EPA, the states that might adopt MON 87701 Soybean due to lepidopteran insectpressure include Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, North Carolina, South Carolina, Tennessee, Texas, and Virginia (Leonard, 2011). Soybean cultivation area in these states totals approximately 18.8 million acres, with organic soybean production totaling 0.13 percent oftotal soybean cultivation (USDA-ERS, 20lOb). A determination ofnonregulated status ofMON 87701 Soybeanwill not result in changes inthe current practices of planting, tillage, fertilizer application/use, cultivation, pesticide application/use and volunteer control. Planting ofMaN 87701 Soybean may locally reduce the amount of insecticides applied to control lepidopteran pests when insect pressures reach economic thresholds. Managementpractices and seed standards for production ofCertified soybean seed would not change. MON 87701 Soybean is EPA-registered for seed increase in the U.S. so that it can be exported for planting in othermarkets. The increase in seed exports that mayresult from a determination ofnonregulated status ofMON 87701 Soybean is small compared to the total export market. Soybean seed exports for crop cultivation are a minorpart ofthe current soybean export market. Soybean exported for replanting represents less than 1percent (i.e., 0.15 percent) ofthe exported soy market. 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofMaN 87701 Soybean would have no significant impacts on human oranimal health. MON 87701 Soybean is compositionally similar to currently available soybeans on the market with the exception ofthe CrylAc protein. CrylAc has an existing exemption from the requirement ofa tolerance in food and feed commodities granted byEPA in 1997. The CrylAc has a history ofsafe use in cotton and com products, is not toxic to humans, and is not likely to be an allergen (USEPA, 1997,2010). Compositional tests conducted bythe petitioner indicate that MON 87701 Soybean is compositionally similarto othercommercially available soybeans (Monsanto,201O). Monsanto initiated the consultation process with FDA for the commercial distribution ofMON 87701 Soybean and submitted a safety and nutritional assessment offood and feed derived from MON 87701 Soybean to the FDA onMay 28, 2009 (BNF No. 000119) (FDA, 2010b). FDA evaluated the submission and responded to the developer by letter onAugust 18, 2010 (FDA, 201 Oa). Based on the information Monsanto submitted, and as ofAugust 5,2010, FDA has no further questions regarding MaN 87701 Soybean. Based on the FDA's consultation, laboratory data and scientific

14

### literature provided byMonsanto (Monsanto, 2010), and safety data available on other CrylAcproducts, APHIS has concluded that MON 87701 Soybean would have no significant impacts on human oranimal health. 

### 3. Unique characteristics of thegeographic area such asproximity to historic orcultural
resources,park lands, prime farmlands, wetlands, wildandscenic rivers, orecologically criticalareas. There are no unique characteristics ofgeographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, orecologically critical areas that would be adversely impacted bya determination ofnonregulated status ofMON 87701 Soybean. The common agricultural practices that would be carried outunder the proposed action will not cause major ground disturbance; do not cause any physical destruction or damage to property; do not cause any alterations ofproperty, wildlife habitat, or landscapes; and do not involve the sale, lease, ortransfer ofownership ofany property. This action is limited to a determination ofnonregulated status ofMON 87701 Soybean. The product will be deployed on agricultural land currently suitable for production of soybeans, will replace existing varieties, and is not expected to increase the acreage of soybean production. This action would not convert land use to nonagricultural use and therefore would have no adverse impact on prime farm land. Standard agricultural practices for land preparation, planting, irrigation, and harvesting ofplants would be used

on agricultural lands planted to MON 87701 Soybean including the use ofEPA registered pesticides. Applicant's adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. In

### the event ofa determination of nonregulated status ofMON 87701 Soybean, the action is not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologicallycritical areas that may be in closeproximityto soybean production sites. 

### 4. The degree to which the effects on the quality of the human environmentare likely to be highly controversial. The effects on the quality ofthe human environment from a determination of nonregulated status ofMON 87701 Soybean are nothighly controversial. Although there is some opposition to a determination ofnonregulated status ofMON 87701 Soybean, this action is nothighlycontroversial in terms ofsize, nature or effect on the natural or physical environment. As discussed in Chapters 4 and 5 ofthe EA, a determination of nonregulated status ofMON 87701 Soybean is not expected to directly cause an increase in agricultural acreage devoted to soybeanproduction, orthose soybean acres devoted to GE soybean cultivation. The availability ofMON 87701 Soybean wi11 not change cultivation areas for soybean production in the U.S. and there are no anticipated changes to the availability ofGE and non-GE soybean varieties on the market. A determination ofnonregulated status ofMON 87701 Soybean couldadd another GE soybean variety to the conventional soybean market and is not expectedto change the market demands for GE soybean orsoybean produced using organic methods. Currently, MON 87701 Soybean is registered bythe EPA for breeding and seed increase activities in the Atlantic Coastal states ofGeorgia, South Carolina, North Carolina, Virginia, and Maryland (USEPA, 2010) and Illinois, Arkansas, and the Commonwealth ofPuerto Rico (U.S. EPA, 2011). This registration is limited to 15,000 total acres in the specified seven states and Puerto Rico, with production limited to 1,000 acres per county (municipio), except for Illinois and Arkansas where it is limited to 300 acres in each state. On a broader scale, if

15MON 8770I Soybean were to be granted a commercial use registration by EPA, the states that might adopt MON 87701 Soybean due to lepidopteran insect pressure include Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, North Carolina, South Carolina, Tennessee, Texas, and Virginia (Leonard, 2011). Together these states account for about 15 percent (approximately 18.8 million acres) ofthe total soybean acres ofthe U.S. (75 million acres) (USDA-ERS, 2010a; USDA-NASS, 2010). A determination ofnonregulated status ofMON 8770I Soybean will not result in changes in the current practices ofplanting, tillage, fertilizer application/use, cultivation, pesticide application/use and volunteer control. Management practices and seed standards for production ofCertified soybean seed would not change. The effect ofMON 87701 Soybean on wildlife orbiodiversity is no different than that of otherBtcrops currently used in agriculture, or other GE ornon-GE soybeanproduced in conventional agriculture in the U.S. During the public commentperiod, APHIS received comments opposing a determination ofnonregulated status ofMON 87701 Soybean. No

new issues, alternatives or substantive new information were identified in any ofthe comments received byAPHIS. One individual expressed a general opposition to genetically modified organisms (GMOs) or GE crops. The comment did not mention a specific disagreement with APHIS' analyses ofMON 87701 Soybean detailed in the EA

orthe PPRA (USDA-APHIS, 2011b); rather it suggests that GE soybean and GE plants generally have a negative effect on human health and environmental safety. The comment did not provide any supporting evidence for its claims. A second comment requested that APHIS analyze the impacts ofMON 8770I Soybean on honeybees and groundwater. APHIS addressed impacts to non-target insects and water quality in the EA. APHIS has addressed substantive comments in the response to public comments document attached to this FONSI based on scientific evidence found in peer-reviewed, scholarly, and scientificjournals. 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 possible effects on the human environment are well understood. The effects ofthe proposed activities are not highly uncertain and do not involve unique or unknown risks on the natural orphysical environment. As discussed in Chapters 4 and 5 ofthe EA, a determination of nonregulated status ofMON 87701 Soybean is not expected to directly calise an increase in agricultural acreage devoted to soybean production, orthose soybean acres devoted to GE soybean cultivation. A determination ofnonregulated status ofMON 87701 Soybean will notresult in changes in the current practices ofplanting, tillage, fertilizer application/use, cultivation, pesticide application/use and volunteer control. Management practices and seed standards for production ofCertified soybean seed would not change. The effect ofMON 87701 Soybean on wildlife orbiodiversity is no different than that ofother Bt crops currently used in agriculture, or other GE ornon-GE soybean produced in conventional agriculture in the U.S. As described in Chapter 2 ofthe well established managementpractices, production controls, and production practices (GE, conventional, and organic) are currentlybeing used in soybean production systems (commercial and seed production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce conventional soybean (GE and non-GE varieties), MON 87701 Soybean, orproduce soybean using organic methods, will continue to use these

16reasonable, commonly accepted best management practices for their chosen systems and varieties during agricultural soybean production. Additionally, GE soybeans currently

are planted on the majority ofsoybean acres in the U.S. (93% ofacreage in 2010) (USDA-ERS, 20lOa). Based upon historic trends, conventional production practices that

use GE varieties will likely continue to dominate in terms ofacreage with orwithout a determination ofnonregulated status ofMON 87701 Soybean. Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use ofGE soybean products and Btagricultural crops, the possible effects to the human environment from the release ofa an additional GE soybean product are alreadywell known and understood. Therefore the impacts are nothighlyuncertain, and do not involve unique orunknown risks. 6. The degree to which the action may establish aprecedent for future actions with significant effects orrepresents a decision inprinciple about a future consideration. A determination ofnonregulated status ofMON 87701 Soybeanwould not establish a precedent for future actions with significant effects orrepresent a decision in principle about a future decision. Similar to pastregulatoryrequests reviewed and approved by APHIS, a determination ofnon regulated status will bebased upon an independent determination onwhether an organism is unlikelyto pose a plantpest risk pursuant to the regulatoryrequirements of7 CFRpart 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes this independent review to determine ifthe regulated article poses a plant pestrisk. Under the authority ofthe plantpestprovisions ofthe Plant Protection Act and 7 CFRPart 340, APHIS has issued regulations for the safe development and use ofGE organisms. As required by7 CFR 340.6, APHIS must respond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as MON 8770I Soybean. When a petition for nonregulated status is submitted, APHIS mustmake a determination ifthe GE organism is unlikelyto pose a plantpestrisk. IfAPHIS determines based on its Plant PestRisk Assessment that the geneticallyengineered organism is unlikely to pose a plantpest risk, the genetically engineered organism is no longer subjectto the plantpestprovisions of the Plant Protection Act and 7 CFRpart 340. APHIS regulations at7 CFRpart 340, which were promulgated pursuant to authority granted bythe PlantProtection Act, as amended (7 United States Code (U.S.c.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plantpestprovisions ofthe Plant Protection Act orto the regulatoryrequirements of7 CFRpart 340 when APHIS determines that itis unlikely to pose a plantpestrisk. A GE organism is considered a regulated article ifthe donororganism, recipient organism, vector, orvector agent used in engineering the organismbelongs to one ofthe taxa listed in the regulation (7 CFR 340.2) and is also considered a plantpest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism maybe a plantpest or APHIS does nothave information to determine ifthe GE organism is unlikely to pose a plantpestrisk. A person maypetition the agency that aparticularregulated article is unlikely to pose a plantpest risk, and, therefore, is no longerregulated under the plant pestprovisions ofthe Plant Protection Act orthe regulations at7 CFR 340. The petitioneris required to provide information under § 340.6(c)( 4) related to plantpest risk that the agencymayuse to determine whetherthe regulated article is unlikely to present a

17greater plant pest risk than the unmodified organism. A OE organism is no longer subject to the regulatory requirements of7 CFRpart 340 or the plant pest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose aplantpest risk. 7. Whether the action is related to other actions with individually insignUicant but cumulatively signijicant impacts. No significant cumulative effects were identified through this assessment. The EA discussed cumulative effects on soybean management practices, human and animal health, and the environment and concluded that such impacts were not significant. A cumulative effects analysis is provided in Chapter 5 ofthe EA, including the potential future expansion ofMON 8770 1 Soybean acreage in the U.S. and the assumption that MON 87701 Soybean will be stacked with a commercially available herbicide resistant soybean variety. In the event APHIS reaches a determination ofnonregulated status of MON 87701 Soybean, APHIS would no longerhave regulatory authority over these soybeans. The petitionerhas indicated the future possibility ofapplying for an EPA registration that would expand the acreage ofMON 87701 Soybean beyond the currently allowable 15,000 acres. OE soybeans currently are planted on the majority ofsoybean

acres in the U.S. (93% ofacreage in 2010) (USDA-ERS, 201Oa). All these OE soybean varieties are herbicide resistant. As a result, the use ofherbicide resistant soybean systems is the most common method inthe U.S. for management ofweeds in soybean fields. Based on this information, it is reasonable to foresee that MON 87701 Soybean would be stacked (combined) with one ormore ofthese herbicide resistant events that are
no longer subjectto the plant pestprovisions ofthe Plant ProtectionAct and 7 CFRpart 340 in the future (USDA-APHIS, 2011b). Ready2YeildTM soybean (product ofa MON 87701 and the nonregulated MON 89788 cross) is already approved in Brazil and may represent a similar variety that would likely be bred for the tropical and subtropical soybean market (USDA-APHIS, 2007). However, there is no guarantee that MON 87701 Soybean will be stacked with any particular nonregulated OE variety, as companyplans and market demands playa significant role in those business decisions. Moreover, MON 87701 Soybean could even be combined with non-OE soybean varieties. Thus, predicting all potential combinations ofstacked varieties that could be created using both GE soybean varieties that are no longer subject to the plantpestprovisions ofthe Plant ProtectionAct and 7 CFR part 340 and also non-OE soybean varieties is hypothetical and purely speculative. In the event ofa determination ofnonregulated status ofMON 87701 Soybean, APHIS has not identified any significant impact on the environment which may result from the incremental impact ofa determination ofnonregulated status ofMON 87701 Soybean when added to otherpast, present, and reasonably foreseeable future actions. 8. The degree to which the action mayadversely affectdistricts, sites, highways, structures.

or objects listed in or eligiblefor listing in the NationalRegister of Historic Places or may cause loss or destruction of significantscientific, cultural, or historical resources. A determination ofnonregulated status ofMON 87701 Soybean will not adversely impact cultural resources on tribal properties. Any farming activities thatmay be taken by farmers on tribal lands are onlyconducted atthe tribe's request; thus, the tribes have control over any potential conflict with cultural resources on tribal properties. A determination ofnonregulated status ofMON 87701 Soybean would have no impact on districts, sites, highways, structures, or objects listed in oreligible for listing in the

18National RegisterofHistoric Places, norwould they likely cause anyloss ordestruction ofsignificant scientific, cultural, orhistorical resources. This action is limited to a determination ofnonregulated status ofMON 87701 Soybean. Standard agricultural· practices for land preparation, planting, irrigation, and harvesting ofplants would be used

on these agricultural lands including the use ofEPA registered pesticides. Applicant's adherence to EPA label use restrictions for all pesticides will mitigate impacts to the human environment. A determination ofnonregulated status ofMON 87701 Soybean is not an undertaking that may directly orindirectly cause alteration in the character oruse ofhistoric properties protected undertheNational Historic Preservation Act. In general,

common agricultural activities conducted underthis action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character oruse ofhistoric properties. Forexample, there is potential for audible effects on the use and enjoyment ofa historicproperty when

common agricultural practices, such as the operation oftractors and othermechanical equipment, are conducted close to such sites. A built-in mitigating factor for this issue is that virtually all ofthe methods involved would onlyhave temporary effects on the audible nature ofa site and can be ended at any time to restore the audible qualities of such sites to theiroriginal conditionwith no further adverse effects. Additionally, these cultivationpractices are alreadybeing conducted throughout the soybeanproduction regions. The cultivation ofMON 87701 Soybean does not inherentlychange any ofthese agronomic practices so as to give rise to an impactunderthe NHPA. 

### 9. The degree to which the action may adversely affect an endangeredorthreatenedspecies

or its habitat that has been determinedto be critical under the EndangeredSpeciesActof 1973. As described in Chapter 6 ofthe EA, APHIS has analyzed the potential for effects from a determination ofnonregulated status ofMON 87701 Soybeanon federally listed threatened and endangered species (TES) and species proposed for listing, as well as designated critical habitat and habitatproposed for designation, as required under Section 7 ofthe Endangered Species Act. Afterreviewingpossible effects ofa determination of nonregulated status ofMON 87701 Soybean, APHIS has determined that a determination ofnonregulated status ofMON 87701 Soybean, would haveno effect on Federallylisted TES and speciesproposed for listing, or on designated critical habitat orhabitatproposed for designation. 

### 10. Whether the action threatens a violation of Federal, State, or local law or requirements imposed for theprotection of the environment. The proposed action wouldbe in compliance with all federal, state, and local laws. Because the agency has concluded that MON 8770I Soybean is unlikelyto pose a plant pestrisk, a determination ofnonregulated status ofMON 87701 Soybean is a response that is consistentwith the plant pest provisions ofthe PPA, the regulations codified in 7 CFRpart 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. Monsanto initiated the consultation process with FDA for the commercial distribution of MON 87701 Soybean and submitted a safetyand nutritional assessment offood and feed derived from MON 87701 Soybean to the FDA on May 28,2009 (BNF No. 000119) (FDA, 201Ob). FDA evaluated the submission and respondedto the developerby letter

onAugust 18,2010 (FDA, 201Oa). Based on the information Monsanto submitted, and

as ofAugust 5, 2010, FDA has no further questions regarding MON 87701 Soybean.

19MON 87701 Soybean is compositionally similarto currently available soybeans on the market with the exception ofthe CrylAc protein. CrylAc has an existing exemption from the requirement ofa tolerance in food and feed commodities granted by EPA in 1997. The CrylAc has a history ofsafe use in cotton and comproducts, is nottoxic to humans, and is not likely to be an allergen (US-EPA, 1997,2010). The EPA regulates PIPs underFIFRA (7 U.S.C. 136 et seq.) and certain biological control organisms under TSCA (15 U.S.c. 53 et seq.). Before planting a crop containing a PIP, a companymust seek an experimental use permit from EPA. Commercial production ofcrops containing PIPs for purposes ofseed increases and sale requires a FIFRA Section 3 registration with EPA. In September 2010, Monsanto received EPA registration for MON 87701 Soybean for breeding and seed increase activities in the Atlantic Coastal states ofGeorgia, South Carolina, North Carolina, Virginia, and Maryland (US-EPA, 2010). In June of2011 the label was changed to include illinois, Arkansas, and the Commonwealth ofPuerto Rico (U.S. EPA, 2011). There are no other Federal, state, orlocal permits that are needed prior to the implementation ofthis action.

NEPA Decision and Rationale I have carefully reviewed the EA prepared for this NEPA determination and the input from the public involvement process. I believethat the issues identified in the EA are best addressed by selectingAlternative 2 (Determination that MON 87701 Soybean is No Longer a Regulated Article). This alternative meets APHIS' purpose and need to allow the safe development and use ofgenetically engineered organisms consistent with the plant pest provisions ofthe Plant Protection Act.

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the agency believes would fulfill its statutory mission and responsibilities, giving consideration to economic, environmental, technical and other factors." Thepreferred alternative has been selected for implementationbased on consideration ofa number ofenvironmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) it allows APHIS to fulfill its statutory mission to protect America's agriculture and environment using a science-based regulatory framework that allows for the safe development and use of genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified anyplant pest risks associated with MON 87701 Soybean, the continued regulated status ofMON 87701 Soybean would be inconsistent with the plantpest provisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnology regulatory policies in the Coordinated Framework. Forthe reasons stated above, I have determined that a determination ofnonregulated status ofMON 87701 Soybean will not have any significant environmental effects.

Michael C. Gregoire Date: Deputy Administrator BiotechnologyRegulatory Services

20Animal and Plant Health Inspection Services U.S. Department ofAgriculture



### Literature Cited:

FDA. (2010a) Biotechnology ConsultationNote to the File BNFNo. 000119, U.S. Food and Drug Administration. FDA. (201Ob) BiotechnologyConsultation Agency Response Letter BNFNo. 000119 (August 18,2010), U.S. FDAlCFSAN. Higley L., Boethel D. (1994) Handbook ofSoybean InsectPests The Entomological Society of America. Leonard R. (2011) RE: Anotherquestion regarding Bt soybeans (Personal Communication), in: C. Blanco (Ed.). pp. 1. Monsanto (2010) Petition for the Determination ofNonregulated Status for MON 87701. Submitted by Q. Zhu, registration manager. Monsanto Company, St. Louis, MO (See Tablehttp://www.aphis.lIsda.gov/biotechnology/not rcg.html). USDA-APHIS. (2007) Finding ofNo Significant Impact, Animal and Plant Health Inspection Service, Petition ofNon-regulated Status for Soybean Line MON 89788 (APHIS 06-178­ 01p), United States Department ofAgriculture

- Animal and Plant Health Inspection Service, Washington DC. USDA-APHIS. (2011a) Petitions for Nonregulated Status Granted orPendingbyAPHIS, United States Department ofAgriculture

- Animal and Plant Health Inspection Service. USDA-APHIS. (2011b) Assessment ofPlant Pest Risk for MON 87701 Soybean, United States Department ofAgriculture, Animal and Plant Health Inspection Service, Riverdale, MD. US-EPA. (1997) Bacillus thuringiensis subspecies kurstaki 

### Cry lAc and the genetic material necessary for its production in all plants; exemption from the requirement ofa tolerance

on all raw agricultural commodities, 62, U.S. Environmental Protection Agency. US-EPA. (201Oa) Biopesticide Registration Action Document:Bacillus thuringiensis Cry1 Ac Protein and the Genetic Material (Vector PV-GMIR9) Necessary for Its Production in MON 87701 (OECD Unique Identifier: MON 87701-2) Soybean [PC Code 006532], U.S. Environmental Protection Agency, Office ofPesticide Programs, Biopesticides and Pollution Prevention Division, Washington, D.C. U.S. EPA. (2011).Plant-Incorporated Protectant Label, Mon 87701, Lepidopteran-Protected Soybean. Washington, D.C. USDA-ERS. (20lOa) Organic Production. USDA-ERS. (201Ob) Adoption ofGeneticallyEngineered Crops in the U.S.: Soybean Varieties, United States Department ofAgriculture

- EconomicResearch Service. USDA-NASS. (2007) Agricultural Chemical Usage 2006 Field Crops Summary, in: U.S. Department ofAgriculture

- National Agricultural Statistics Service (Ed.). USDA-NASS. (2010) Acreage, United States Department ofAgriculture

- National Agriculture Statistics Service, Washington, D.C. USDA-NASS. (2011a) Crop Production 2010 Summary: January 2011, United States Department ofAgriculture

- National Agricultural Statistics Service, Washington, D.C.

21USDA-NASS. (20 11b) Statistics by Subject

- National Statistics for Soybeans,United States Department ofAgriculture National Agricultural Statistics Service.

van Frankenhuyzen K. (2009) Insecticidal activity ofBacillus thuringiensis crystal proteins. Journal ofInvertebrate Pathology 101:1-16. DOl: lO.1016/j.jip.2009.02.009.

22

### Attachment Finding ofNo Significant Impact Response to Comments Petition 09-082-01p

On June 28, 2011, APHIS published anotice in the Federal Register (76 FR37770- 37771

­ 27303, Docketno APHIS-20Il-0038) announcing the availability ofthe Monsanto petition, and the APHIS PPRA and draft EA for a 60-daypublic review and commentperiod. Comments

were required to bereceived on orbefore August 29, 2011. All comments were carefully analyzed to identifynew issues, alternatives, or information. A total offour comments were received from individuals during the commentperiod. Two public comments referenced a different soybean line; these were outside the scope ofthe action being considered bythe Agency in this docket. These comments were referred to the docket ofthe referenced soybean line. One comment expressed opposition to a determination ofnonregulated status ofMON 8770I Soybean, butdid not change the analysis provided in the PPRA ordraft EA. These individuals did not mention their specific disagreement with APHIS' analyses ofMON 87701 Soybean detailed in the EA orthe PPRA(USDA-APHIS, 20lla); rather, theymade general statements about unknowns associated with the use ofgeneticallymodified organisms (GMOs)

orGE crops. The second comment suggests that APHIS should analyze the impacts ofMON 87701 Soybean on bees and groundwater. Impacts to non-target insects and impacts on water are both addressed in the EA. The author ofthe comment did not offer anynew information or mention any specific disagreement with APHIS' analyses ofMON 87701 Soybean detailed in the EA orthe PPRA(USDA-APHIS, 20lla). No new issues, alternatives or substantivenew information were identified in any ofthe comments received byAPHIS.

Comment: The soybean is claimed, in the backup documents, to be self-pollinating. In spiteofthat statement, bees, in their natural course ofexistence should be considered. With the fragility ofbees and Colony CollapseDisorder, why risk any crop to future destruction by genetically engineered crops or herbicides. Any studies would haveto involve decades ofresearch and monitoring with impacts on crops, insects, plants,wildlife and birds across theboard andwith sufficientradius to determine effects.
Response: As discussed in Section 

### IV ofthe EA, potential impacts ofGE and non-GE soybean production practices on non-target species would beunchanged when compared to current soybean productionpractices. The use ofinsecticides, otherthan Bt crops, may affectnon-target organisms includinghoneybees, soil invertebrates, orculturable microbial flora (US-EPA, 2005). A notable advantage ofGE insecticidal (Bt) crops over conventional insecticides is the high specificity ofthe Bttoxins, which minimize the potential toxic effects on non-target insects. Soybean production systems in agriculture are host to many animal species. Mammals and birds mayuse soybean fields and the surrounding vegetation for food and habitatthroughout the year. There is ample information indicating that Cry Bttoxins do not negatively affect mammals orbirds (Smirnoffand MacLeod, 1961). Invertebrates can feed on soybean plants or preyupon otherinsects living on soybean plants, as well as in the vegetation surrounding soybean fields. Because the Cry proteins expressed byBacillus thuringiensis, 

### such as CrylAc,

are very specific for lepidoptera, other arthropods, including honey bees, are not likelyto be affected (van Frankenhuyzen, 2009).

23Plants that were genetically engineered to express the Cry proteins have a history ofsafe use in the V,S. Since the mid-1990s, com and cotton lines that express these proteins have been commercialized without deleterious impacts on non-target organisms (Mendelsohn et aI., 2003; US-EPA, 2008a; USDA-APHIS, 2011b). The use oftransgenic cotton producingthe Cry1Ac protein has been shown to reduce the use ofbroad spectrum insecticides 2 without significant impacts on the diversity ofnon-target insects (Cattaneo et al., 2006; Dively, 2005; Marvier, 2007; Naranjo, 2005a; Naranjo, 2005b; Romeis et al., 2006; Torres and Ruberson, 2006; Torres

. and Ruberson, 2005; Whitehouse et aI., 2005). MON 87701 Soybean is expected to be similar

with respect to the low potential harm to the environment. Because Cryl receptors are not present in non-target birds and mammals (Hofmann et al., 1988a; Hofmann et al., 1988b; Shimada et aI., 2006a; Shimada et al., 2006b; Van Rie et al., 1990), this insecticidal protein is not expected to adversely affect non-target invertebrates (other than lepidoptera) and vertebrate organisms (US-EPA, 2008b).

Monsanto presented information about the effect that CrylAc has on selected non-target insects (honeybee, green lacewing, ladybird beetle and parasitic wasp (Monsanto, 2010) and provided information ofpeerreviewed studies that provide evidence for the lack oftoxicity ofCry proteins on a variety ofarthropod. Assessments ofinsecticidal transgenic crops include laboratorytests with indicatortest species to determine potential toxicity at toxin doses higher than would be anticipated under field conditions (Rose and Dively, 2007). The information submitted in the petition indicates that no statistically significant adverse etIects were observed at the maximum test dose for a number ofthe tested species. Otherresearch has also shown no direct adverse effects on insectivorous insects in field and laboratory studies with transgenic plants expressing Cryproteins (Marvier, 2007; Pilcher et aI., 1997; Romeis et al., 2004; Romeis

. et aL, 2006). Based on the above information, APHIS concludes that MON 87701 Soybean will have no adverse effects on non-target animals.

Comment: Groundwater and any NPDES discharge would need to be studied, monitoring and analyzed. Downstream analysis would be needed. Any future assessment ofor use of taxpayerfunds including cleanup and oversight ofcontaminationwould need to be considered as an impact.
Response: APHIS considered the impacts on water ofapproving the petition for nonregulated status for MON 87701 Soybean. As discussed in section IV ofthe EA, planting ofMON 87701 Soybean in these seven states and Puerto Rico may locally reduce the amount ofinsecticides applied to control lepidopteran pests. To the extent that MON 87701 Soybean reduces the application ofinsecticides, it could reduce chemical runoffinto surface water and groundwater. However, pesticides are only applied when insect pressures reach economic thresholds, MON 87701 Soybean would likelybe effective for controlling lepidopteranpests in any seed field where it is planted and therefore could reduce the localized use ofinsecticides in that field. However, ifother insect pest like, stink bugs, were causing damage to the soybean crop, MON

2 Broad spectrum insecticides are chemical insect1c1des wh1ch loll msects that are causmg 1l1Jury to plants and also kill other insects that are not causing injury to the plant. Insects that are inadvertently killed by the application of insecticide are called "non-target"insects. Because the Cry protems are specific for a narrow range ofinsects, use of Cry!Ac to control plant pests is recognized as being beneficial to the survival ofnon-target insects (US-EPA, 2008a).


### 248770I Soybean would have no effect on those insects orthe insecticide required to control those pests.

In addition, any benefits associated with planting ofMON 87701 Soybean are limitedbythe relatively small permittedplanting area. Because the fields arenot a large component ofthe agricultural landscape (less that 0.1% ofthe total soybean acreage), plantingMON 87701 Soybean will not have an effect onpestpopulations orapplication ofinsecticides to control insectpests. Therefore, there is no expected change in the impacts ofinsecticide use on surface

orground water quality.

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