NATIONAL ENVIRONMENTAL POLICY ACT DECISION 


AND 


FINDING OF NO SIGNIFICANT IMPACT 


Monsanto Company 


Event MON 87701 Soybean 


United States Department of Agriculture 


Animal and Plant Health Inspection Service 


Biotechnology Regulatory Services 


The United States Department of Agriculture (USDA), Animal and Plant Health Inspection 

Service (APHIS) has developed this decision document to comply with the requirements of the 

National Environmental Policy Act (NEPA) of 1969, as amended, the Council of Environmental 

Quality's (CEQ) "regulations implementing NEPA, and the USDA APHIS' NEPA implementing 

regulations and procedures, This NEPA decision document, a Finding of No Significant Impact 

(FONSI), sets forth APHIS' NEPA decision and its rationale. Comments from the public 

involvement process were evaluated and considered in developing this NEPA decision. 

In accordance with APHls procedures implementing NEPA (7 CFR part 372), APHIS has 

prepared an Environmental Assessment (EA) to evaluate and determine if there are any 

potentially significant impacts to the human environment from a determination on the regulated 

status ofa petition request (APHIS Number 09-082-0 I p) by Monsanto Company (Monsanto) for 

their genetically engineered Event MON 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 order to specifically evaluate the effects on the quality of 

the human environment l that may result from approving the petition seeking nonregulated status 

for MON 87701 Soybean. The EA assesses alternatives to a determination ofnonregulated 

status of MON 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 only modified 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 

EP A label change has been incorporated into the final EA and this NEP A decision document. 

Regulatory Authority 

"Protecting American agriculture" is the basic charge of APHIS, APHIS provides leadership in 

ensuring the health and care of plants and animals. The agency improves agricultural 

productivity and competitiveness, and contributes to the national economy and the public health. 

USDA asserts that all methods of agricultural production (conventional, organic, or the use of 

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 government has regulated genetically engineered (GE) organisms 

pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of 

Biotechnology (Coordinated Framework) (51 FR 23302,57 FR 22984). The Coordinated 

Framework, published by the Office of Science and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

products and explains how federal agencies will use existing Federal statutes in a manner to 

ensure public health and environmental safety while maintaining regulatory flexibility to avoid 

impeding the growth of the biotechnology industry. The Coordinated Framework is based on 

several important guiding principles: (1) agencies should define those transgenic organisms 

subject to review to the extent permitted by their respective statutory authorities; (2) agencies are 

required to focus on the characteristics and risks of the biotechnology product, not the process by 

which it is created; (3) agencies are mandated to exercise oversight ofGE organisms only when 

there is evidence of "unreasonable" risk. 

The Coordinated Framework explains the 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 and plants under the plant pest provision in 

the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment. 

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic 

Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all 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 under Federal food safety 

laws, FDA encourages them to participate in a voluntary consultation process. All food and feed 

derived from GE crops currently on the market in the United States have successfully completed 

this consultation process. The FDA policy statement concerning regulation of products derived 

from new plant varieties, including those genetically engineered, was published in the Federal 

Register on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a 

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

issues (e.g., labeling) are resolved prior to commercial distribution ofbioengineered food. 

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides 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 under the Toxic Substances Control Act (TSCA). The EPA is responsible for 

regUlating the sale, distribution, and use of pesticides, including pesticides that are produced by 

an organism through techniques of modern biotechnology. 

Regulated Organisms 

2 

The APHIS Biotechnology Regulatory Service's (BRS) 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 of GE 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, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions of the 

Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. 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 of the taxa listed in the regulation (7 CFR 340.2) and is also considered 

a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe 

that the GE organism may be a plant pest or APHIS does not have information to determine if 

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

A person may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant 

Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide information 

under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

GE organism is no longer subject to the regulatory requirements of7 CFR part 340 or the plant 

pest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a 

plant pest risk. 

APHIS' Response to Petition for Nonregulated Status 

Under the authority ofthe plant pest provisions ofthe Plant Protection Act and 7 CFR Part 340, 

APHIS has issued regulations for the safe development and use ofGE organisms. As required 

by 7 CFR 340.6, APHIS must respond to petitioners who request a determination ofthe 

regulated status ofGE organisms, including GE plants such as MON 87701 Soybean. When a 

petition for nonregulated status is submitted, APHIS must make a determination ifthe GE 

organism is unlikely to pose a plant pest risk. 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 pest provisions of the Plant 

Protection Act and 7 CFR part 340. 

Monsanto has submitted a petition (APHIS Number 09-082-01p) to APHIS seeking a 

determination that their genetically engineered MON 87701 Soybean is unlikely to pose a plant 

pest risk and, therefore, should no longer be a regulated article under regulations 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 of soybean plants (Higley and Boethel, 1994). Because 

it bores into the stem, larvae are protected from insecticidal sprays. Control ofthese insects 

requires high levels of systemic insecticide treatment. To be effective, the application ofthese 

3 

insecticides 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 of insects 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 if Monsanto obtains 

appropriate registrations from the EPA (Monsanto, 2010). Currently, MON 87701 Soybean has 

only received 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 of Puerto 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 of EPA registration precludes commercial sale of MON 87701 Soybean 

in the US. 

Coordinated Framework Review 

Food and Drug Administration 

MON 87701 Soybean is within the scope of the FDA policy 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 of MaN 87701 Soybean and submitted a safety and nutritional assessment of food 

and feed derived from MON 87701 Soybean to the FDA on May 28, 2009 (BNF No. 000119) 

(FDA, 201 Ob). 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 Protection Agency 

The EPA regulates plant-incorporated protectants (PIPs) under FIFRA (7 US.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 company must seek anexperimental use permit from EPA. Commercial 

production of crops containing PIPs for purposes of seed 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 of Georgia, South Carolina, North Carolina, Virginia, and Maryland with no 

more than 1,000 acres per county per year. 

3) 	 Monsanto must submit IRM monitoring and remedial action plans to EPA for approval 

by January 31, 2011, and reports on such annually by August 31 s1. 

4) 	 Monsanto must provide EPA annual reports on the acreage and States where MON 87701 

Soybean has been grown by January 31 st. 

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 

4 

date of this registration. Namely, Monsanto must submit a 7-10 day freshwater 

invertebrate toxicity study or otherwise adequately address aquatic invertebrate issues 

raised by Rosi- Marshall, et al. in 2007 regarding the leaf shredding (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 of Puerto Rico. The label permits up to 300 

acres in Arkansas or Illinois, and up to 100 acres per municipio in Puerto Rico. There is still 

a limit oftotal 15,000 acres in the allowed areas (U.S. EPA, 2011). 

Scope of the Environmental Analysis 

Although a determination ofnonregulated status ofMON 87701 Soybean would allow for new 

plantings ofMON 87701 Soybean to occur anywhere in the U.S., APHIS primarily focused the 

environmental analysis to those geographic areas where MON 8770 I Soybean could be grown. 

MON 87701 Soybean is regulated in part by FIFRA, due to characteri.zatioh of the CrylAc 

protein product as a pesticide by the EPA. Currently, MON 87701 Soybean is registered by the 

EPA for breeding and seed increase activities in the Atlantic Coastal states of 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). 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 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 

of EPA registration. Thus, the scope of analysis of the EA focuses on the cultivation of MON 

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 the Federal Register (76 FR 37770-37771, 

Docket no. APHIS-2011-0038) announcing the availability of the Monsanto petition, and the 

APHIS PPRA and draft EA for a 60-day public review and comment period. Comments were 

required to be received on or before August 29, 2011. All comments were carefully analyzed to 

identify new issues, alternatives, or information. A total of four comments were received from 

individuals during the comment period. Comment documents may be viewed 

at http://wvvw .regulations. gov I#! searchResu I ts;rpp= 1 O:po=O;s=aphis-2011-0038. Two public 

comments referenced a different soybean line; these were outside the scope ofthe action being 

considered by the Agency in this docket. These comments were referred to the docket of the 

referenced soybean line. One comment expressed opposition to a determination ofnonregulated 

status ofMON 87701 Soybean, but did not change the analysis provided in the PPRA or draft 

EA. This individual did not mention a specific disagreement with APHIS' analyses of MON 

87701 Soybean detailed in the EA or the PPRA(USDA-APHIS, 20lla); rather, the comment 

made general statements about unknowns associated with the use of genetically modified 

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 of the comment did not offer any 

new information or mention any specific disagreement with APHIS' analyses ofMON 87701 

Soybean detailed in the EA or the PPRA(USDA-APHIS, 20l1a). No new issues, alternatives or 

5 

substantive new information were identified in any of the comments received by APHIS. 

Responses to substantive comments are included as an attachment to this Finding of No 

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 of the Plant 

Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a 

determination ofnonregulated status ofMON 87701 Soybean. Issues discussed in the EA were 

developed by considering public concerns as well as issues raised in public comments submitted 

for other environmental assessments of genetically 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 of soybean using various production 

methods, and the environmental and food/feed safety of genetically engineered plants were 

addressed to analyze the potential environmental impacts of MON 87701 Soybean. 

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

following issues were identified as important to the scope of the analysis (40 CFR 1508.25): 

Agricultural Production Considerations: 

• Acreage and Areas of Soybean 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 

6 
Alternatives that were fully analyzed 

The EA analyzes the potential environmental consequences of a 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 plant pest risk. Based 

on its Plant Pest Risk Assessment (USDA-APHIS, 20 11 b), APHIS has concluded that MON 

87701 Soybean is unlikely to pose a plant pest risk. Therefore, APHIS must determine that 

MON 87701 Soybean is no longer subject to 7 CFR part 340 or the plant pest provisions of the 

Plant Protection 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 of the EA. 

No Action: Continuation as a Regulated Article 

Under the 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 CFR part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions ofMON 87701 Soybean and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS might choose this 

alternative if there were insufficient evidence to demonstrate the lack of plant pest risk 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 unlikely to pose a plant pest risk (USDAAPHIS, 20 11 a). Choosing this alternative would not satisfy the purpose and need ofmaking a 

determination of plant pest risk status and responding to the petition for nonregulated status .. 

Preferred Alternative: Determination that MON 87701 Soybean is No Longer a Regulated 

Article 

Under this alternative, MON 87701 Soybean and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. MON 87701 Soybean is unlikely to 

pose a plant pest risk (USDA-APHIS, 2011a). Permits issued or notifications acknowledged by 

APHIS would no longer be required for introductions ofMON 87701 Soybean and progeny 

derived from this event. This alternative best meets the purpose and need to respond 

appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 

and the agency's authority under the plant pest provisions of the Plant Protection Act. Because 

the agency has concluded that MON 87701 Soybean is unlikely to pose a plant pest risk, a 

determination ofnonregulated status ofMON 87701 Soybean is a response that is consistent 

with the plant pest provisions ofthe PPA, the regulations codified in 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework. Under this alternative, 

growers may have 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 of alternatives that might be considered for MON 87701 Soybean. The 

agency evaluated these alternatives, in light of the agency's authority under the plant pest 

provisions ofthe Plant Protection Act, and the regulations at 7 CFR part 340, with respect to 

environmental safety, efficacy, and practicality to identify which alternatives would be further 

7 

considered 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. 

Prohibit any MON 87701 Soybean/rom being released 

In response to public comments that stated a preference that no GE organisms enter the 

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 Protection Act, Congress found that 

[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under [the Plant Protection Act] shall be based on sound science ... § 402(4). 

On March 11, 2011, in a Memorandum for the Heads of Executive 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 of policies for oversight of emerging 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 be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandates 

of each agency" 

Based on our Plant 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 

pest risk. Accordingly, there is no basis in science for prohibiting the release of MON 87701 

Soybean. 

Approve the petition in part 

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 of nonregulated status in part may be appropriate if 

there is a plant pest risk associated with some, but not all tines described in a petition. Because 

APHIS has concluded that MON 87701 Soybean is unlikely to pose a plant pest risk, there is no 

regulatory basis under the plant pest provisions of the Plant Protection Act for considering 

approval of the petition only in part. 

Isolation distance between lYION 87701 Soybean and non-GE soybean and geographical 

restrictions 

In response to public concerns of gene 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 

8 

requiring isolation distances would be inconsistent with the statutory authority under the plant 

pest provisions ofthe Plant Protection Act and regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production of MON 87701 Soybean to 

those areas where MON 87701 Soybean were allowed to be grown by EPA. EPA regulates 

MON 87701 Soybean under FIFRA. However, as presented in APHIS' plant pest risk 

assessment for MON 8770 I Soybean, there are no geographic differences associated with any 

identifiable plant pest risks 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 not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographically 

restricted area. Therefore, such an alternative would not be consistent with APHIS' statutory 

authority under the plant pest provisions ofthe Plant Protection Act and regulations in Part 340 

and the biotechnology regulatory policies embodied in the Coordinated Framework. 

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status 

based on the requirements in 7 CFR part 340 and the agency's authority under the plant pest 

provisions ofthe Plant Protection Act. 

Requirement o/Testing For MON 87701 Soybean 

During the comment periods for other petitions for nonregulated status, some commenters 

requested USDA to require and provide testing to identify GE 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 plant pest risk (USDA-APHIS, 201Ia), the imposition of any type oftesting 

requirements is inconsistent with the plant pest provisions ofthe Plant Protection Act, the 

regulations at 7 CFR part 340 and the biotechnology regulatory policies 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 of APHIS' Selected Action 

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

details. The following table briefly summarizes the results for each ofthe issues fully analyzed 

in the Environmental Consequences section of the 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 

9 

Alternative B: Determination I Attribute/Measure Alternative A: No Action .... . ..' of Nonregulated 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 

8770 I soy - will depend on Unchanged from No 

type of insect pest. Due to Action Alternative 

limited acreage will not 

change national or regional 

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 Water Resources · to have any effect on water 

MON 8770 I is not expected Soil Unchanged 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 

lO 
Plants 

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 

or horizontal gene flow. 

Unchanged 

Unchanged 

Soil Microorganisms 

MON 87701 is not expected 

to have any effect on soil ' Unchanged 

microorganisms. 

MON 87701 is not expected 

Biological Diversity to have any effect on Unchanged 

biological diversity. 

uman and Animal Health 

Risk to Human Health 

Risk to Animal Feed 

Socioeconomic 

Domestic Economic 

Environment 

Trade Economic 

Environment 

MON 8770 I does not have 

adverse human health effects 

MON 87701 does change the 

nutritional qualities of animal 

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 of No Significant Impact 

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

cumulatively, on the quality ofthe human environment as a result ofthis proposed action. I 

11 
agree with this conclusion and therefore find that an EIS need not be prepared. This NEP A 

determination is based on the following context and intensity factors (40 CFR 1508.27): 

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

and setting in which the environmental impact would occur. This action has potential to affect 

conventional and organic 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 by FIFRA, due to 

characterization of the Cry1Ac protein product as a pesticide by the EPA. Currently, MON 

87701 Soybean is registered by the 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 of Puerto Rico (U.S. EPA, 2011). This 

registration is limited to 15,000 total acres in the specified states and Puerto Rico. Production is 

limited to 1,000 acres per county or municipio, 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 

under this type of EPA 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 of Monsanto to expand that market into the U.S. 

(Monsanto, 2010). If approved by the EPA for commercial sale, MON 87701 Soybean 

cultivation would not be 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 87701 Soybean 

acreage in the U.S. is considered as part of the 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 soybean plants from lepidopteran insect damage. 

Currently, insecticides are used on only about 16% of the soybean acres planted in the U.S. 

(USDA-NASS, 2007). Only a portion of these acres are managed for lepidopteran insect pests. 

The states that might adopt MON 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 of the U.S. It is unlikely that all of these 

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

areas of a state. Therefore, it is likely that if MON 87701 Soybean were to become available in 

the U.S. in the future, the adoption rate would be less than 15 percent of the total U.S. soybean 

production. The adoption rate would be driven by the price of MON 87701 Soybean seed, the 

cost of insecticides, the likelihood of damage levels from lepidopteran pcsts that reach economic 

thresholds, and the price ofsoybeans. 

A determination of nonregulated status of MON 87701 Soybean is not expected to directly 

cause an increase in agricultural acreage devoted to soybean production, or those soybean 

acres devoted to GE soybean cultivation. The availability of MON 87701 Soybean will not 

change cultivation areas for soybean production in the U.S. and there are no anticipated changes 

to the availability of GE and non-GE soybean varieties on the market. Due to planting 

restrictions defined by the EPA seed increase registration, cultivation of MON 87701 Soybean 

would remain a small percentage of total 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 of the 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 nor the crossing 

ofMON 87701 Soybean with an herbicide-resistant soybean variety is likely to expand the range 

of soybeans 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 of current agronomic management due to agricultural input requirements. GE soybeans 

currently are planted on the majority of soybean acres in the U.S. (93% of acreage in 2010) 

(USDA-ERS, 20 lOa). All these GE soybean varieties are herbicide resistant. As a result, the use 

of herbicide resistant soybean systems is the most common method in the U.S. for management 

of weeds in soybean fields. Based on this information, it is reasonable to foresee that MON 

87701 Soybean would be combined with one or more ofthese herbicide resistant events that are 

no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340 in 

the future (USDA-APHIS, 2011b). 

Although a determination ofnonregulated status ofMON 87701 Soybean would allow for new 

plantings ofMON 87701 Soybean to occur anywhere in the U.S., APHIS primarily focused the 

environmental analysis to those geographic areas where MON 87701 Soybean could be grown. A 

determination ofnonregulated status ofMON 87701 Soybean is not expected to increase 

soybean production, either by its availability alone or accompanied by other factors, or cause an 

increase in overall GE soybean acreage. 

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

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

1. Impacts that may be both benefiCial and adverse. 

A determination ofnonregulated status ofMON 87701 Soybean will have no significant 

environmental impact in relation to the availability of GE, conventional or organic 

soybean varieties. As discussed in Chapters 4 and 5 ofthe EA, a determination of 

nonregulated status of MON 8770 I Soybean is not expected to directly cause an increase 

in agricultural acreage devoted to soybean production, or those soybean acres devoted 

to GE soybean cultivation. The availability of MON 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 

of nonregulated status of MON 8770 I Soybean could add another GE soybean variety 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% of soybean acres in the U.S., respectively (USDAERS,20lOa). All of the GE soybean varieties are herbicide resistant. As a result, the use 

of herbicide resistant soybean systems is the most common method in the U.S. for 

management of weeds in soybean fields. Based on this information, it is reasonable to 

foresee that MON 87701 Soybean would be combined with one or more of these 

herbicide resistant events that are no longer subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR part 340 in the future (USDA-APHIS, 2011b). 

Currently, MON 87701 Soybean is registered by the EPA for breeding and seed increase 

activities in the states of Georgia, South Carolina, North Carolina, Virginia, and 

13 

Maryland (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 may represent up to 0.09 percent oftotal soybean acreage. The 

majority of the remaining soybeans (about 90 percent) are nonregulated GE soybeans 

(USDA-ERS, 201 Oa), with organic soybean production in these six states representing 

less than 2 percent of total 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, or less 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 insect pressure 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, 20 lOb). A determination ofnonregulated 

status ofMON 87701 Soybean will not result in changes in the 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. Management practices 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 other markets. The increase 

in seed exports that may result from a determination ofnonregulated status ofMON 

87701 Soybean is small compared to the total export market. Soybean seed exports for 

crop cultivation are a minor part of the current soybean export market. Soybean exported 

for replanting represents less than 1 percent (i.e., 0.15 percent) of the exported soy 

market. 

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

A determination of nonregulated status ofMaN 87701 Soybean would have no 

significant impacts on human or animal health. MON 87701 Soybean is compositionally 

similar to currently available soybeans on the market with the exception of the CrylAc 

protein. CrylAc has an existing exemption from the requirement of a tolerance in food 

and feed commodities granted by EPA in 1997. The CrylAc has a history of safe 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 by the petitioner indicate that MON 

87701 Soybean is compositionally similar to other commercially 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 on May 28, 

2009 (BNF No. 000119) (FDA, 2010b). FDA evaluated the submission and responded 

to the developer by letter on August 18, 2010 (FDA, 201 Oa). Based on the information 

Monsanto submitted, and as of August 5,2010, FDA has no further questions regarding 

MaN 87701 Soybean. Based on the FDA's consultation, laboratory data and scientific 

14 
literature provided by Monsanto (Monsanto, 2010), and safety data available on other 

CrylAc products, APHIS has concluded that MON 87701 Soybean would have no 

significant impacts on human or animal health. 

3. 	 Unique characteristics ofthe geographic area such as proximity to historic or cultural 

resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically 

critical areas. 

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

lands, wetlands, wild and scenic areas, or ecologically critical areas that would be 

adversely impacted by a determination of non regulated status ofMON 87701 Soybean. 

The common agricultural practices that would be carried out under 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, or transfer of ownership of any 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 of plants would be used 

on agricultural lands planted to MON 87701 Soybean including the use of EPA registered 

pesticides. Applicant's adherence to EPA label use restrictions for all pesticides will 

mitigate potential impacts to the human environment. In the event of a 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 

ecologically critical areas that may be in close proximity to soybean production sites. 

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

highly controversial. 

The effects on the quality of the human environment from a determination of 

nonregulated status ofMON 87701 Soybean are not highly controversial. Although there 

is some opposition to a determination ofnonregulated status ofMON 87701 Soybean, 

this action is not highly controversial in terms of size, 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 soybean production, or those soybean acres devoted 

to GE soybean cultivation. The availability of MON 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 could add another GE soybean variety to 

the conventional soybean market and is not expected to change the market demands for 

GE soybean or soybean produced using organic methods. Currently, MON 87701 

Soybean is registered by the 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 

15 

MON 8770 I 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 of the U.S. (75 million acres) (USDA-ERS, 2010a; USDA-NASS, 2010). 

A determination of nonregulated status ofMON 8770 I Soybean will not result in 

changes in the current practices of planting, tillage, fertilizer application/use, 

cultivation, pesticide application/use and volunteer control. Management practices 

and seed standards for production of Certified soybean seed would not change. The 

effect ofMON 87701 Soybean on wildlife or biodiversity is no different than that of 

other Bt crops currently used in agriculture, or other GE or non-GE soybean produced in 

conventional agriculture in the U.S. During the public comment period, APHIS received 

comments opposing a determination of non regulated status ofMON 87701 Soybean. No 

new issues, alternatives or substantive new information were identified in any of the 

comments received by APHIS. 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 

or the 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 of MON 8770 I Soybean on honey bees 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 scientific journals. 

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

or involve unique or unknown risks. 

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

environment are well understood. The effects of the proposed activities are not highly 

uncertain and do not involve unique or unknown risks on the natural or physical 

environment. As discussed in Chapters 4 and 5 of the EA, a determination of 

nonregulated status ofMON 87701 Soybean is not expected to directly calise an increase 

in agricultural acreage devoted to soybean production, or those soybean acres devoted 

to GE soybean cultivation. A determination ofnonregulated status ofMON 87701 

Soybean will not result in changes in the current practices of planting, tillage, 

fertilizer application/use, cultivation, pesticide application/use and volunteer control. 

Management practices and seed standards for production of Certified soybean seed would 

not change. The effect ofMON 87701 Soybean on wildlife or biodiversity is no different 

than that ofother Bt crops currently used in agriculture, or other GE or non-GE soybean 

produced in conventional agriculture in the U.S. As described in Chapter 2 of the 

well established management practices, production controls, and production practices 

(GE, conventional, and organic) are currently being 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, or produce soybean using organic methods, will continue to use these 

16 
reasonable, commonly accepted best management practices for their chosen systems and 

varieties during agricultural soybean production. Additionally, GE soybeans currently 

are planted on the majority of soybean acres in the U.S. (93% of acreage in 2010) 

(USDA-ERS, 20 lOa). Based upon historic trends, conventional production practices that 

use GE varieties will likely continue to dominate in terms of acreage with or without 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 Bt agricultural crops, the possible effects to the human 

environment from the release of a an additional GE soybean product are already well 

known and understood. Therefore the impacts are not highly uncertain, and do not 

involve unique or unknown risks. 

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

significant effects or represents a decision in principle about a future consideration. 

A determination ofnonregulated status ofMON 87701 Soybean would not establish a 

precedent for future actions with significant effects or represent a decision in principle 

about a future decision. Similar to past regulatory requests reviewed and approved by 

APHIS, a determination ofnon regulated status will be based upon an independent 

determination on whether an organism is unlikely to pose a plant pest risk pursuant to the 

regulatory requirements of 7 CFR part 340. Each petition that APHIS receives is specific 

to a particular GE organism and undergoes this independent review to determine if the 

regulated article poses a plant pest risk. Under the authority of the plant pest provisions 

of the Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the 

safe development and use ofGE organisms. As required by 7 CFR 340.6, APHIS must 

respond to petitioners who request a determination ofthe regulated status of GE 

organisms, including GE plants such as MON 8770 I Soybean. When a petition for 

nonregulated status is submitted, APHIS must make a determination ifthe GE organism 

is unlikely to pose a plant pest risk. If APHIS determines based on its Plant Pest Risk 

Assessment that the genetically engineered organism is unlikely to pose a plant pest risk, 

the genetically engineered organism is no longer subject to the plant pest provisions of 

the Plant Protection Act and 7 CFR part 340. APHIS regulations at 7 CFR part 340, 

which were promulgated pursuant to authority granted by the Plant Protection Act, as 

amended (7 United States Code (U.S.c.) 7701-7772), regulate the introduction 

(importation, interstate movement, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions 

ofthe Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when 

APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is 

considered a regulated article if the donor organism, recipient organism, vector, or vector 

agent used in engineering the organism belongs to one of the taxa listed in the regulation 

(7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under 

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

APHIS does not have information to determine ifthe GE organism is unlikely to pose a 

plant pest risk. A person may petition the agency that a particular regulated article is 

unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant 

pest provisions ofthe Plant Protection Act or the regulations at 7 CFR 340. The 

petitioner is required to provide information under § 340.6( c)( 4) related to plant pest risk 

that the agency may use to determine whether the regulated article is unlikely to present a 

17 

greater plant pest risk than the unmodified organism. A OE organism is no longer subject 

to the regulatory requirements of7 CFR part 340 or the plant pest provisions of the Plant 

Protection Act when APHIS determines that it is unlikely to pose a plant pest 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 of the 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 of nonregulated status of 

MON 87701 Soybean, APHIS would no longer have regulatory authority over these 

soybeans. The petitioner has indicated the future possibility of applying for an EPA 

registration that would expand the acreage of MON 87701 Soybean beyond the currently 

allowable 15,000 acres. OE soybeans currently are planted on the majority of soybean 

acres in the U.S. (93% of acreage in 2010) (USDA-ERS, 201Oa). All these OE soybean 

varieties are herbicide resistant. As a result, the use of herbicide resistant soybean 

systems is the most common method in the U.S. for management of weeds in soybean 

fields. Based on this information, it is reasonable to foresee that MON 87701 Soybean 

would be stacked (combined) with one or more of these herbicide resistant events that are 

no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFR part 

340 in the future (USDA-APHIS, 2011 b). Ready2YeildTM soybean (product of a 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 company plans 

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 of stacked varieties that could be created using both 

GE soybean varieties that are no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340 and also non-OE soybean varieties is hypothetical and 

purely speculative. In the event of a determination of nonregulated status ofMON 87701 

Soybean, APHIS has not identified any significant impact on the environment which may 

result from the incremental impact of a determination of nonregulated status ofMON 

87701 Soybean when added to other past, present, and reasonably foreseeable future 

actions. 

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

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

may cause loss or destruction ofsignificant scientific, cultural, or historical resources. 

A determination ofnonregulated status ofMON 87701 Soybean will not adversely 

impact cultural resources on tribal properties. Any farming activities that may be taken 

by farmers on tribal lands are only conducted at the tribe's request; thus, the tribes have 

control over any potential conflict with cultural resources on tribal properties. A 

determination of nonregulated status of MON 87701 Soybean would have no impact on 

districts, sites, highways, structures, or objects listed in or eligible for listing in the 

18 
National Register of Historic Places, nor would they likely cause any loss or destruction 

of significant scientific, cultural, or historical resources. This action is limited to a 

determination ofnonregulated status ofMON 87701 Soybean. Standard agricultural· 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on these agricultural lands including the use of EPA 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 or indirectly cause alteration in the character or use 

of historic properties protected under the National Historic Preservation Act. In general, 

common agricultural activities conducted under this 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 or use of historic properties. For example, there is 

potential for audible effects on the use and enjoyment of a historic property when 

common agricultural practices, such as the operation oftractors and other mechanical 

equipment, are conducted close to such sites. A built-in mitigating factor for this issue is 

that virtually all of the methods involved would only have temporary effects on the 

audible nature of a site and can be ended at any time to restore the audible qualities of 

such sites to their original condition with no further adverse effects. Additionally, these 

cultivation practices are already being conducted throughout the soybean production 

regions. The cultivation of MON 87701 Soybean does not inherently change any of these 

agronomic practices so as to give rise to an impact under the NHP A. 

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

or its habitat that has been determined to be critical under the Endangered Species Act of 

1973. 

As described in Chapter 6 of the EA, APHIS has analyzed the potential for effects from a 

determination ofnonregulated status ofMON 87701 Soybean on federally listed 

threatened and endangered species (TES) and species proposed for listing, as well as 

designated critical habitat and habitat proposed for designation, as required under Section 

7 of the Endangered Species Act. After reviewing possible effects of a determination of 

nonregulated status ofMON 87701 Soybean, APHIS has determined that a determination 

ofnonregulated status ofMON 87701 Soybean, would have no effect on Federally listed 

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

for designation. 

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

imposedfor the protection ofthe environment. 

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

Because the agency has concluded that MON 8770 I Soybean is unlikely to pose a plant 

pest risk, a determination ofnonregulated status ofMON 87701 Soybean is a response 

that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 

CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. 

Monsanto initiated the consultation process with FDA for the commercial distribution of 

MON 87701 Soybean and submitted a safety and nutritional assessment of food and feed 

derived from MON 87701 Soybean to the FDA on May 28,2009 (BNF No. 000119) 

(FDA, 201 Ob). FDA evaluated the submission and responded to the developer by letter 

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

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

19 
MON 87701 Soybean is compositionally similar to currently available soybeans on the 

market with the exception of the CrylAc protein. CrylAc has an existing exemption 

from the requirement of a tolerance in food and feed commodities granted by EPA in 

1997. The CrylAc has a history of safe use in cotton and com products, is not toxic to 

humans, and is not likely to be an allergen (US-EPA, 1997,2010). The EPA regulates 

PIPs under FIFRA (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 company must 

seek an experimental use permit from EPA. Commercial production of crops containing 

PIPs for purposes of seed 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 of Georgia, South 

Carolina, North Carolina, Virginia, and Maryland (US-EPA, 2010). In June of2011 the 

label was changed to include illinois, Arkansas, and the Commonwealth of Puerto Rico 

(U.S. EPA, 2011). There are no other Federal, state, or local permits that are needed 

prior to the implementation of this 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 believe that the issues identified in the EA are best addressed by 

selecting Alternative 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 

of genetically 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." The preferred alternative has been 

selected for implementation based on consideration of a number of environmental, regulatory, 

and social factors. Based upon our evaluation and analysis, Alternative 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 any plant pest risks associated with MON 87701 

Soybean, the continued regulated status ofMON 87701 Soybean would be inconsistent with the 

plant pest provisions ofthe PP A, the regulations codified at 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework. For the 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 

Biotechnology Regulatory Services 

20 

Animal and Plant Health Inspection Services 

U.S. Department of Agriculture 

Literature Cited: 

FDA. (2010a) Biotechnology Consultation Note to the File BNF No. 000119, U.S. Food and 


Drug Administration. 


FDA. (201 Ob) Biotechnology Consultation Agency Response Letter BNF No. 000119 (August 


18,2010), U.S. FDAlCFSAN. 


Higley L., Boethel D. (1994) Handbook of Soybean Insect Pests The Entomological Society of 


America. 


Leonard R. (2011) RE: Another question 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 


Table http://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

01 p), United States Department of Agriculture - Animal and Plant Health Inspection 

Service, Washington DC. 

USDA-APHIS. (2011a) Petitions for Nonregulated Status Granted or Pending by APHIS, United 

States Department of Agriculture - Animal and Plant Health Inspection Service. 

USDA-APHIS. (2011 b) Assessment of Plant Pest Risk for MON 87701 Soybean, United States 

Department of Agriculture, 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 of a tolerance 

on all raw agricultural commodities, 62, U.S. Environmental Protection Agency. 

US-EP A. (201 Oa) 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 of Pesticide 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. (20 lOa) Organic Production. 

USDA-ERS. (201Ob) Adoption of Genetically Engineered Crops in the U.S.: Soybean Varieties, 

United States Department ofAgriculture - Economic Research Service. 

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

Department of Agriculture - 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 of Agriculture - National Agricultural Statistics Service, Washington, D.C. 

21 

USDA-NASS. (20 11 b) Statistics by Subject - National Statistics for Soybeans,United States 

Department of Agriculture National Agricultural Statistics Service. 

van Frankenhuyzen K. (2009) Insecticidal activity of Bacillus thuringiensis crystal proteins. 

Journal ofInvertebrate Pathology 101:1-16. DOl: lO.1016/j.jip.2009.02.009. 

22 

Attachment 


Finding of No Significant Impact 


Response to Comments 


Petition 09-082-01p 


On June 28, 2011, APHIS published a notice in the Federal Register (76 FR 37770- 37771 ­

27303, Docket no APHIS-20Il-0038) announcing the availability of the Monsanto petition, and 

the APHIS PPRA and draft EA for a 60-day public review and comment period. Comments 

were required to be received on or before 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. Two public comments referenced a 

different soybean line; these were outside the scope ofthe action being considered by the 

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 

8770 I Soybean, but did not change the analysis provided in the PPRA or draft EA. These 

individuals did not mention their specific disagreement with APHIS' analyses ofMON 87701 

Soybean detailed in the EA or the PPRA(USDA-APHIS, 20lla); rather, they made general 

statements about unknowns associated with the use of genetically modified 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 or 

mention any specific disagreement with APHIS' analyses ofMON 87701 Soybean detailed in 

the EA or the PPRA(USDA-APHIS, 20lla). No new issues, alternatives or substantive new 

information were identified in any of the comments received by APHIS. 

Comment: The soybean is claimed, in the backup documents, to be self-pollinating. In 

spite of that statement, bees, in their natural course of existence should be considered. With 

the fragility of bees and Colony Collapse Disorder, why risk any crop to future destruction 

by genetically engineered crops or herbicides. Any studies would have to involve decades 

of research and monitoring with impacts on crops, insects, plants, wildlife and birds across 

the board and with sufficient radius to determine effects. 

Response: As discussed in Section IV of the EA, potential impacts ofGE and non-GE soybean 

production practices on non-target species would be unchanged when compared to current 

soybean production practices. The use ofinsecticides, other than Bt crops, may affect non-target 

organisms including honey bees, soil invertebrates, or culturable microbial flora (US-EPA, 

2005). A notable advantage ofGE insecticidal (Bt) crops over conventional insecticides is the 

high specificity of the Bt toxins, which minimize the potential toxic effects on non-target insects. 

Soybean production systems in agriculture are host to many animal species. Mammals and 

birds may use soybean fields and the surrounding vegetation for food and habitat throughout the 

year. There is ample information indicating that Cry Bt toxins do not negatively affect 

mammals or birds (Smirnoff and MacLeod, 1961). Invertebrates can feed on soybean plants or 

prey upon other insects living on soybean plants, as well as in the vegetation surrounding 

soybean fields. Because the Cry proteins expressed by Bacillus thuringiensis, such as CrylAc, 

are very specific for lepidoptera, other arthropods, including honey bees, are not likely to be 

affected (van Frankenhuyzen, 2009). 

23 
Plants that were genetically engineered to express the Cry proteins have a history of safe 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 of transgenic cotton producing the Cry1Ac 

protein has been shown to reduce the use of broad spectrum insecticides 2 without significant 

impacts on the diversity of non-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 of peer reviewed studies that provide evidence for the lack of toxicity of Cry 

proteins on a variety of arthropod. Assessments of insecticidal transgenic crops include 

laboratory tests with indicator test 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 of the tested species. Other research has also shown no 

direct adverse effects on insectivorous insects in field and laboratory studies with transgenic 

plants expressing Cry proteins (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 of or use of 

taxpayer funds including cleanup and oversight of contamination would need to be 

considered as an impact. 

Response: APHIS considered the impacts on water of approving the petition for nonregulated 

status for MON 87701 Soybean. As discussed in section IV of the EA, planting ofMON 87701 

Soybean in these seven states and Puerto Rico may locally reduce the amount of insecticides 

applied to control lepidopteran pests. To the extent that MON 87701 Soybean reduces the 

application of insecticides, it could reduce chemical runoff into surface water and groundwater. 

However, pesticides are only applied when insect pressures reach economic thresholds, MON 

87701 Soybean would likely be effective for controlling lepidopteran pests in any seed field 

where it is planted and therefore could reduce the localized use of insecticides in that field. 

However, if other 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 prot ems are specific for a narrow range of insects, use of 

Cry! Ac to control plant pests is recognized as being beneficial to the survival of non-target insects (US-EPA, 

2008a). 

24 
8770 I Soybean would have no effect on those insects or the insecticide required to control those 

pests. 

In addition, any benefits associated with planting ofMON 87701 Soybean are limited by the 

relatively small permitted planting area. Because the fields are not a large component ofthe 

agricultural landscape (less that 0.1 % ofthe total soybean acreage), planting MON 87701 

Soybean will not have an effect on pest populations or application of insecticides to control 

insect pests. Therefore, there is no expected change in the impacts of insecticide use on surface 

or ground water quality. 

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