i

Monsanto Company Petition (09-SY-194U) for 

Determination of Non-regulated Status of Event MON 

87701 

OECD Unique Identifier: 

MON-87701-2

Final Environmental Assessment 

September 2011

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of 

race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. 

(Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for 

communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center 

at (202) 720–2600 (voice and TDD). 

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326–W, Whitten Building, 1400 

Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal 

opportunity provider and employer. 

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

U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any 

product mentioned. Product names are mentioned solely to report factually on available data and to provide specific 

information. 

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State 

and/or Federal agencies before they can be recommended. 
ii
TABLE OF CONTENTS PAGE

i

ACRONYMS AND ABBREVIATIONS.......................................................................... V

1 PURPOSE AND NEED.............................................................................................. 1

1.1 REGULATORY AUTHORITY................................................................................. 1

1.1 Regulated Organisms ........................................................................................... 1

1.2 Petition for Determination of Nonregulated Status: Monsanto 87701 Soybean.. 2

1.3 Purpose of Product ............................................................................................... 3

1.4 APHIS Response to Petition for Nonregulated Status......................................... 3

1.5 Coordinated Framework Review ......................................................................... 4

1.5.1 Environmental Protection Agency................................................................ 4

1.5.2 Food and Drug Administration ..................................................................... 4

1.6 Public Involvement .............................................................................................. 5

1.7 Issues Considered................................................................................................. 5

2 AFFECTED ENVIRONMENT.................................................................................. 7

2.1 Agricultural Production of Soybean..................................................................... 7

2.1.1 Acreage and Area of Soybean Production.................................................... 7

2.1.2 Agronomic Practices..................................................................................... 9

2.1.3 Soybean Seed Production ........................................................................... 11

2.1.4 Organic Soybean Production ...................................................................... 13

2.2 Physical Environment ........................................................................................ 15

2.2.1 Water Resources ......................................................................................... 15

2.2.2 Soil Quality................................................................................................. 15

2.2.3 Air Quality .................................................................................................. 16

2.2.4 Climate Change........................................................................................... 16

2.3 Biological Resources.......................................................................................... 17

2.3.1 Animal Communities.................................................................................. 17

2.3.2 Plants Communities.................................................................................... 18

2.3.3 Gene Flow and Weediness.......................................................................... 18

2.3.4 Microorganisms .......................................................................................... 19

2.3.5 Biodiversity................................................................................................. 19

2.4 Human Health .................................................................................................... 20

2.5 Animal Feed ....................................................................................................... 21

2.6 Socioeconomic ................................................................................................... 21

2.6.1 Domestic Economic Environment .............................................................. 21

2.6.2 Trade Economic Environment .................................................................... 22

3 ALTERNATIVES..................................................................................................... 25

3.1 No Action Alternative: Continuation as a Regulated Article............................ 25

3.2 Preferred Alternative: Determination that MON 87701 Soybean Is No Longer a 

Regulated Article ............................................................................................... 25
TABLE OF CONTENTS PAGE

ii

3.3 Alternatives Considered But Rejected from Further Consideration .................. 26

3.3.1 Prohibit Any MON 87701 from Being Released........................................ 26

3.3.2 Approve the Petition in Part........................................................................ 26

3.3.3 Isolation Distance between MON 87701 and Non-GE Soybean Production 

and Geographical Restrictions.................................................................... 27

3.3.4 Requirement of Testing for MON 87701.................................................... 27

3.4 Comparison of Alternatives ............................................................................... 28

4 ENVIRONMENTAL CONSEQUENCES ............................................................... 31

4.1 Scope of Analysis............................................................................................... 31

4.2 Agricultural Production of Soybean................................................................... 32

4.2.1 Acreage and Area of Soybean Production.................................................. 32

4.2.2 Agronomic Practices................................................................................... 32

4.2.3 Soybean Seed Production ........................................................................... 34

4.2.4 Organic Soybean Production ...................................................................... 34

4.3 Physical Environment ........................................................................................ 35

4.3.1 Water Resources ......................................................................................... 35

4.3.2 Soil Quality................................................................................................. 36

4.3.3 Air Quality .................................................................................................. 37

4.3.4 Climate Change........................................................................................... 39

4.4 Biological Resources.......................................................................................... 40

4.4.1 Animal Communities.................................................................................. 40

4.4.2 Plant Communities...................................................................................... 41

4.4.3 Gene Flow and Weediness.......................................................................... 42

4.4.4 Microorganisms .......................................................................................... 43

4.4.5 Biodiversity................................................................................................. 44

4.5 Human Health .................................................................................................... 45

4.5.1 No Action Alternative: Human Health ....................................................... 45

4.5.2 Preferred Alternative: Human Health ......................................................... 46

4.6 Animal Feed ....................................................................................................... 47

4.7 Socioeconomic Impacts...................................................................................... 48

4.7.1 Domestic Economic Environment .............................................................. 48

4.7.2 Trade Economic Environment .................................................................... 48

5 CUMULATIVE IMPACTS...................................................................................... 50

5.1 Assumptions Used for Cumulative Imptacts Analysis....................................... 50

5.2 Cumulative Impacts: Acreage and Area of Soybean Production....................... 51

5.3 Cumulative Impacts: Agronomic Practices........................................................ 52

5.4 Cumulative Impacts: Soybean Seed Production ................................................ 53

5.5 Cumulative Impacts: Organic Soybean Production ........................................... 53

5.6 Cumulative Impacts: Water Resources.............................................................. 53
TABLE OF CONTENTS PAGE

iii

5.7 Cumulative Impacts: Soil Quality...................................................................... 54

5.8 Cumulative Impacts: Air Quality ....................................................................... 54

5.9 Cumulative Impacts: Climate Change................................................................ 55

5.10 Cumulative Impacts: Animal Communities....................................................... 55

5.11 Cumulative Impacts: Plant Communities........................................................... 57

5.12 Cumulative Impacts: Gene Flow and Weediness............................................... 57

5.13 Cumulative Impacts: Microorganisms............................................................... 57

5.14 Cumulative Impacts: Biodiversity...................................................................... 58

5.15 Cumulative Impacts: Human Health.................................................................. 58

5.16 Cumulative Impacts: Animal Feed..................................................................... 59

5.17 Cumulative Impacts: Domestic Economic Environment................................... 59

5.18 Cumulative Impacts: Trade Economic Environment......................................... 60

6 THREATENED AND ENDANGERED SPECIES ................................................. 63

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS................................................. 66

7.1.1 Executive Orders with Domestic Implications........................................... 66

7.1.2 International Implications........................................................................... 68

7.1.3 Compliance with Clean Water Act and Clean Air Act............................... 69

7.1.4 Impacts on Unique Characteristics of Geographic Areas........................... 69

7.1.5 National Historic Preservation Act (NHPA) of 1966 as Amended ............ 70

8 REFERENCES ......................................................................................................... 71

APPENDIX A - APHIS THREATENED AND ENDANGERED SPECIES DECISION TREE 

FOR FWS CONSULTATIONS .............................................................................. 83

LIST OF TABLES

Table 1. Soybean production in 2010 in the states where Mon 87701 is labeled for use. 8

Table 2: Recommended insecticides for use on soybeans. ...............................................11

Table 3: Organic soybean production in seven U.S. states in 2008..................................14

Table 4: Summary of issues of potential impacts and consequences of alternatives........28

Table 5: Soybean trade long-term projections..................................................................62

LIST OF FIGURES

Figure 1: U.S. cropland acreage trends, 1945-2002.............................................................7

Figure 2: Annual soybean acres harvested in states where Mon 87701 is labeled for use ..9

Figure 3: Value of U.S. soybean exports to South America, 2005-2010 ..........................23
TABLE OF CONTENTS PAGE

iv

Figure 4: Average soybean seed exports, 2005-2010 ........................................................24
v

ACRONYMS AND ABBREVIATIONS

AIA advanced informed agreement

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BRAD Biopesticide Registration Action Document

BRS Biotechnology Regulatory Services (within USDA–APHIS)

Bt Bacillus thuringiensis protein

CAA Clean Air Act

CBD Convention on Biological Diversity

CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CH4 methane

CO carbon monoxide

CO2 carbon dioxide

DNA deoxyribonucleic acid

DT drought tolerant

EA environmental assessment

EIS environmental impact statement

EO Executive Order

EPA U.S. Environmental Protection Agency

ESA Endangered Species Act of 1973

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register

GDP gross domestic product

GE genetically engineered

GHG greenhouse gas

GMO genetically modified organism

IP Identity Preservation

IPCC Intergovernmental Panel on Climate Change

IRM Insect Resistance Management
vi

ACRONYMS AND ABBREVIATIONS

ISPM International Standard for Phytosanitary Measure

IPPC International Plant Protection Convention

LD50 lethal dose that kills 50% of the animals being tested

NO2 nitrogen dioxide

N2O nitrous oxide

NAAQS National Ambient Air Quality Standards

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

NEPA National Environmental Policy Act of 1969 and subsequent amendments

NHPA National Historic Preservation Act

NOEL no observable effect level

NRC National Research Council

PPRA Plant Pest Risk Assessment

PPA Plant Protection Act

PRA pest risk analysis

RNA ribonucleic acid

TES threatened and endangered species

TSCA Toxic Substances Control Act

U.S. United States

USDA U.S. Department of Agriculture

USDA-ERS U.S. Department of Agriculture-Economic Research Service

USDA-FAS U.S. Department of Agriculture-Foreign Agricultural Service

USDA-NASS U.S. Department of Agriculture-National Agricultural Statistics Service

USDA-NOP U.S. Department of Agriculture-National Organic Program

USC United States Code

WPS Worker Protection Standard for Agricultural Pesticides
1

1 PURPOSE AND NEED

1.1 REGULATORY AUTHORITY

"Protecting American agriculture" is the basic charge of the United States Department of 

Agriculture's (USDA) Animal and Plant Health Inspection Service (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 genetically engineered varieties) can provide 

benefits to the environment, consumers, and farm income. 

Since 1986, the United States (U.S.) 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 of GE 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 Animal and Plant Health 

Inspection Service (APHIS), the U.S. Food and Drug Administration (FDA), and the U.S. 

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 plant-derived 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 
2

regulatory issues (e.g., labeling) are resolved prior to commercial distribution of 

bioengineered 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.

1.1 Regulated Organisms

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 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 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 of 7 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.

1.2 Petition for Determination of Nonregulated Status: Monsanto 87701 Soybean

The Monsanto Company (Monsanto) of St. Louis, MO, submitted a petition (APHIS 

Number 09-082-01p) to APHIS in 2009 for determination of nonregulated status for 

Event MON 87701 soybean that expresses a Cry1Ac protein to protect it from 

lepidopteran insect damage. In the event of a determination of nonregulated status, the 

nonregulated status for MON 87707 would include MON 87701, any progeny derived 

from crosses between MON 87701 and conventional soybean, and crosses of MON 
3

87701 with other biotechnology-derived soybean that are no longer subject to the plant 

pest provisions of the Plant Protection Act and 7 CFR part 340. Event MON 87701 is 

currently regulated under 7 CFR part 340. Interstate movements and field trials of MON 

87701 have been conducted under permits issued or notifications acknowledged by 

APHIS since 2002. Data resulting from these field trials are described in the Monsanto 

Company petition. 

1.3 Purpose of Product

MON 87701 soybean expresses an insecticidal protein, Cry1Ac, 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 of these insects requires high levels of systemic insecticide treatment. 

To be effective, the application of these insecticides needs to be carefully timed (Higley 

and Boethel, 1994). 

Cry1Ac is a lepidopteran-specific (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, U.S. growers may eventually adopt MON 87701 for 

commercial production if Monsanto obtains appropriate registrations from the EPA 

(Monsanto, 2010). Currently, MON 87701 has only received EPA approval for breeding 

and seed multiplication activities for a total of 15,000 acres in Georgia, Puerto Rico, 

South Carolina, North Carolina, Virginia, Illinois, Arkansas, and Maryland with no more 

than 1,000 acres per county per year (300 total in the states Illinois or Arkansas). This 

type of EPA registration precludes commercial sale of MON 87701 in the U.S. 

1.4 APHIS Response to Petition for Nonregulated Status

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 of GE 

organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners that request 

a determination of the regulated status of genetically engineered organisms, including GE 

plants such as MON 87701 soybean. When a petition for nonregulated status is 

submitted, APHIS must make a determination if the genetically engineered organism is 

unlikely to pose a plant pest risk. If APHIS 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 the plant pest 

provisions of the Plant Protection Act and 7 CFR part 340. 

APHIS has prepared this environmental assessment (EA) to consider the potential 

environmental effects of an agency determination of nonregulated status consistent with 

Council of Environmental Quality’s NEPA regulations (40 CFR parts 1500-1508, 7 CFR 

part 1b, and 7 CFR part 372) and the USDA and APHIS NEPA implementing regulations 

and procedures. This EA has been prepared in order to specifically evaluate the effects 
4

on the quality of the human environment1 that may result from a determination on 

nonregulated status of MON 87701 soybean. 

1.5 Coordinated Framework Review

1.5.1 Environmental Protection Agency

The EPA regulates plant-incorporated protectants (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 seed increase, only, 

with the following terms and conditions (US-EPA, 2010a):

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 31st.

4) Monsanto must provide 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 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, 2010a).

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 of total 15,000 acres in the allowed areas (U.S. EPA, 2011). 

1.5.2 Food and Drug Administration

FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq.). 

The FDA published its policy statement concerning regulation of products derived from 

new plant varieties, including those GE, in the Federal Register on May 29, 1992 (57 FR 

 1 Under NEPA regulations, the “human environment” includes “the natural and physical environment and 

the relationship of people with that environment” (40 CFR §1508.14).
5

22984). Under this policy, FDA implements a voluntary consultation process to ensure 

that human food and animal feed safety issues or other regulatory issues, such as labeling, 

are resolved before commercial distribution of bioengineered food. 

MON 87701 is within the scope of the FDA policy statement concerning regulation of 

products derived from new plant varieties, including those produced through genetic 

engineering. The Monsanto Company initiated the consultation process with FDA for the 

commercial distribution of MON 87701 and submitted a safety and nutritional 

assessment of food and feed derived from MON 87701 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, 2010a). Based on the information the 

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

regarding MON 87701 soybean.

1.6 Public Involvement

APHIS routinely seeks public comment on draft EAs prepared in response to petitions for 

nonregulated status GE organisms. APHIS does this through a notice published in 

the Federal Register. The issues discussed in this EA were developed by considering the 

public concerns as well as issues raised in public comments submitted for other EAs of 

GE organisms, concerns raised in lawsuits, as well as those issues of concern that have 

been raised by various stakeholders. These issues, including those regarding the 

agricultural production of soybeans using various production methods and the 

environmental and food/feed safety of GE plants were addressed to analyze the potential 

environmental impacts of MON 87701 soybean.

This EA, the petition submitted by Monsanto, and APHIS’s PPRA will be available for 

public comment for a period of 60 days (7 CFR § 340.6(d)(2)). Comments received by 

the end of the 60-day period will be analyzed and used to inform APHIS’ determination 

decision of the regulated status of MON 87701 and to assist APHIS in determining 

whether an Environmental Impact Statement (EIS) is required prior to the determination 

decision of the regulated status of this soybean variety.

1.7 Issues Considered

The list of resource areas considered in this EA were developed by APHIS through 

experience in considering public concerns and issues raised in public comments 

submitted for other EAs of GE organisms. The resource areas considered also address 

concerns raised in previous and unrelated lawsuits, as well as issues that have been raised 

by various stakeholders in the past. The resource areas considered in this EA can be 

categorized as follows: 

Agricultural Production Considerations:

• Acreage and Areas of Soybean Production

• Agronomic/Cropping Practices

• Soybean Seed Production

• Organic Soybean Production
6

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
7

2 AFFECTED ENVIRONMENT

2.1 Agricultural Production of Soybean

Soybean (Glycine max (L.) Merr.) is an economically important leguminous crop, 

providing oil and protein. Soybean plants are grown for their seed, which is further 

processed to yield oil and meal. Soybean is ranked number one in oil production (56 

percent) among the major oil seed crops production in the world (ASA, 2011). Other 

expanding uses for soybeans in the U.S. include soy biodiesel, animal agriculture, 

exports, and edible soybean oil (USB, 2007).

2.1.1 Acreage and Area of Soybean Production

The U.S. has a land mass of about 2.3 billion acres, with approximately 440 million acres 

(nearly 20 percent) utilized as cropland in 2002 (Fernandez-Cornejo and Caswell, 2006). 

U.S. cropland use has remained relatively consistent since World War II, although it has 

declined over the last few decades (Lubowski et al., 2006). In general, cropland in the 

Atlantic Coastal states (i.e., Georgia, South Carolina, North Carolina, Virginia, and 

Maryland) has declined during the last half of the 20th century and this trend is likely to 

continue (Figure 1). In the states of Illinois and Arkansas it has remained relatively 

constant, with the expectation that land use will remain the same. (Data was not 

available for Puerto Rico). It should be noted that not all cropland is used for planting 

crops; some is fallow and some has been converted to pasture. 

Figure 1. U.S. cropland acreage trends, 1945-2002

Source:(Lubowski et al., 2006).

Soybean cultivation acreage has trended slightly upward over the last decade. However, 

there are fluctuations in the total soybean planted from year to year (USDA-NASS, 

0

5,000

10,000

15,000

20,000

25,000

30,000

1945194919541959196419691974197819821987199219972002

1000's of acres 

Cropland trends since World War II

 South Carolina

 Georgia

 North Carolina

 Virginia

 Maryland

 Illinois

 Arkansas
8

2011b). In 2010, approximately 15.5 million acres of soybeans were planted in the states 

where MON 87701 has received EPA approval (Table 1). This data does not include 

soybean production in Puerto Rico. Soybean production is not listed in Puerto Rico in 

the 2007 Census of Agriculture. However, soybean winter nurseries for breeding 

programs do operate in Puerto Rico. The extent of the total soybean nursery acreage is 

not known, but is likely to be small when compared to other crop production in the 

commonwealth. 

Of these Atlantic Coastal states, North Carolina harvests the most acres of soybeans each 

year. Production in these states peaked in the 1980’s (Figure 2). Over the past decade 

there has been a small upward trend in acres of soybeans harvested in Atlantic Coastal 

States, although the acreage is still below the peak from the 1980’s. Similarly in 

Arkansas soybean production appears to have peaked in the 1980’s. Illinois produces far 

more soybeans than any of the other states where Mon 87701 can be grown. Production 

in this state has generally trended upward; however in more recently it has declined 

slightly (Figure 2). 

Table 1. Soybean production in 20101 in the states where Mon 87701 is labeled for 

use.

State2

Area harvested

(x 1,000 Acres)

Production

(x 1,000 bushels)

Percentage of total 

U.S. soybean 

production area3

Georgia 260 6,760 0.20

Maryland 465 15,810 0.47

North Carolina 1,550 40,300 1.21

South Carolina 455 10,465 0.31

Virginia 540 14,040 0.42

Illinois 9,100 466,075 14.1

Arkansas 3,150 110,250 3.34

Total 15,520 663,700 20.1

1

Information from (USDA-NASS, 2011b). No data was available for Puerto Rico 2 Information obtained from (U.S. EPA, 2011; US-EPA, 2010a). 3

Total U.S. production for 2010 was 3.33 billion bushels (USDA-NASS, 2011b).
9

Figure 2. Annual soybean acres harvested in states where Mon 87701 is labeled for 

use

Source: (USDA-NASS, 2011b). 

2.1.2 Agronomic Practices

Conventional farming in this document includes any farming system where synthetic 

pesticides or fertilizers may be used. Conventional farming covers a broad scope of 

farming practices, ranging from farmers who only occasionally use synthetic pesticides 

and fertilizers to those farmers whose harvest depends on regular pesticide and fertilizer 

inputs. This definition of conventional farming also includes the use of genetically 

engineered (GE) varieties that are no longer subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR part 340. 

Prior to planting, the soil must be stripped of weeds that would otherwise compete with 

the crop for space, water, and light. Conservation tillage is an adopted practice that 

reduces soil erosion, increases plant matter content in the soil, and aids in water 

penetration while reducing agrochemical runoff (Heatherly et al., 2009). Conservation 

tillage where soybeans are irrigated may reduce water and fertilizer runoff, in part due to 

a greater protective plant residue on top of soil (Heatherly et al., 2009). 

Soybean production typically involves the use of agronomic inputs to maximize yield. It 

has been documented that nitrogen fertilization of soybeans is unnecessary; it is an extra 

0

2000

4000

6000

8000

10000

12000

1930 1940 1950 1960 1970 1980 1990 2000 2010

thousands of acres harvested

year

Soybean Acres Harvested in States on Mon 87701 label

Arkansas

Georgia

Illinois

Maryland

North Carolina

South Carolina

Virginia
10

expense that may result in water contamination (Heatherly et al., 2009). Irrigation 

enhances soybean production, especially where rainfall is erratic or not sufficient. 

Commercial soybean production may require the application of pesticides. Weeds are the 

most problematic aspect of soybean production and may require at least one herbicide 

application for effective control. According to Woodruff et al. (2010), giant ragweed, 

pigweed, morning glory, and smartweed are billed as the top four most troublesome 

weeds (Woodruff et al., 2010). Weeds are generally controlled by planting glyphosate 

tolerant soybean varieties, although instances of glyphosate resistant weeds have been 

reported, such as pigweed and morning glory (Heatherly et al., 2009; Woodruff et al., 

2010). These weeds can be managed by applying herbicide combinations with different 

modes of action, as well as crop rotation, varying row spacing, and mechanical removal 

of weeds (Woodruff et al., 2010). In 2002, it was calculated that 96 percent of all planted 

soybeans were treated with at least one type of herbicide, ranging from 0.04 to 0.71 

pounds (lbs) of product per acre. In 2006, herbicides were used on 98 percent of soybean 

acres (USDA-NASS, 2007).

Additionally, soybeans are susceptible to insect attack by caterpillars that feed on foliage 

and seeds. While a variety of lepidopteran and non-lepidopteran insects infest soybean 

(Musser and Catchot, 2008; Musser et al., 2009; Way, 1994), Pseudoplusia includens 

(soybean looper) is currently reported as the most important lepidopteran soybean pest in 

the southern U.S.

In 2006, insecticides were used on 16 percent of soybean acres. The three most common 

insecticides, lambda-cyhalothrin, chlorpyrifos, and esfenvalerate, were applied to 6, 5, 

and 3 percent of the planted acres, respectively (USDA-NASS, 2007). In addition to 

these three insecticides, other are recommended for use on soybeans. Table 2 shows the 

insecticides recommended for use on soybeans (UMD, 2009). 
11

Table 2. Recommended insecticides for use on soybeans.

Insecticide

Rate of active 

ingredient per acre

Time limits:

days before harvest Class

beta-cyfluthrin 0.007-0.013 lb grain + feeding dry vines: 

45, green forage: 15

pyrethroid

cyfluthrin 0.025-0.044 lb 45 pyrethroid

gammacyhalothrin 0.0075-0.0125 lb 45 pyrethroid

zeta-cypermethrin 0.018-0.025 lb 21 pyrethroid

zeta-cypermethrin 

plus bifentrhin 

0.10 lb 21 pyrethroid

bifenthrin 0.08-0.10 lb 18 pyrethroid

esfenvalerate 0.015-0.03 lb

(0.03-0.05 lb bean 

leaf beetle)

21 pyrethroid

lambdacyhalothrin 0.015-0.025 lb 30 pyrethroid

permethrin 0.05-0.1 lb 60 pyrethroid

methomyl 0.23-0.45 lb 14 N-methyl carbamate

thiodicarb 0.25-0.75 lb 28 N-methyl carbamate

chlorpyrifos 0.5-1.0 lb 28 chlorinated 

organophosphate

acephate 0.73-0.97 lb 14 organophosphate

dimethoate 0.5 lb 28 organophosphate

indoxacarb 0.045-0.11 lb 21 oxadiazines

methoxyfenozide 0.06-0.12 14 diacylhydrazine

Table reproduced from (UMD, 2009).

Crop rotations between soybeans and a grain can be an effective strategy to reduce root 

injury from rootworm larvae (Heatherly et al., 2009). Due to the capacity of soybeans to 

fix atmospheric nitrogen into the soil, soybean rotation with grains (mainly corn or 

sorghum) has proven a positive yield return for both crops, but it has the potential of 

increasing soil erosion as a result of the crop rotation. Because of the capacity of 

soybeans to fix nitrogen, the use of variable fertilizer rate technology, which applies 

fertilizer only to areas where it is needed, is another adopted practice on this rotation 

system. 

2.1.3 Soybean Seed Production

Seed quality (including genetic purity, vigor, and presence of weed seed, seed-borne 

diseases, and inert materials, such as dirt) is a major factor in crop yields. If natural 

variability in seed production is not carefully controlled, the value of a new variety or 

cultivar may be lost (Harlan, 1975). Genetic purity in commercial seed production is 
12

generally regulated through a system of seed certification which is intended to ensure that 

the desired traits in the seed are maintained throughout all stages in cultivation (Harlan, 

1975). 

The U.S. Federal Seed Act of 1939 recognizes seed certification and official certifying 

agencies. Implementing regulations further recognize land history, field isolation, and 

varietal purity standards for seed. States have developed seed laws and certification 

agencies to ensure that purchasers who received certified seed can be assured that the 

seed meets established seed quality standards (Bradford, 2006). 

Soybean seed is separated into four seed classes: 1) Breeder; 2) Foundation; 3) 

Registered; and 4) Certified (NCCIA, 2011). Each class of seed is identified to designate 

the seed generation from the original breeder source (Hartman, 1999) . The original 

Breeder seed stock is controlled by the developer of the variety (Hartman, 1999). The 

Breeder stock is used to produce Foundation seed stock (Adam, 2005). Foundation seed 

stock, in turn, is used to produce Registered seed for distribution to licensees, such as 

seed companies (Adam, 2005). Registered seed is used by seed companies to produce 

large quantities of Certified seed (Adam, 2005; Hartman, 1999). The Certified (or select) 

seed is then sold to growers through commercial channels (Adam, 2005; Hartman, 1999). 

Foundation seed, Registered seed, and Certified seed production is controlled by public 

or private seed certification programs (AOSCA Moline, 2009). Commercially certified 

soybean seed must meet state and Federal seed standards and labeling requirements. 

Federal Seed Act regulations are detailed in 7 CFR 201. State seed certification standards 

may vary slightly from state to state and can be more restrictive than the seed standards 

of AOSCA (Association of Official Seed Certifying Agencies) (Department, 2001; 

GCIA, 1988; NCCIA, 2011). The values for certified soybean seed standards from 

AOSCA are as follows (AOSCA Moline, 2009): 

• 98% pure seed (minimum);

• 2% inert matter (maximum); 

• 0.05% weed seed (maximum; not to exceed 10 per pound (lb)); 

• 0.60% total of other crop seeds (maximum); 

• 0.5% other varieties (maximum; includes off-colored beans and off-type seeds); 

• 0.10% other crop seeds (maximum; not to exceed three per lb); and 

• 80% germination and hard seed (minimum). 

In addition to these specific factors, soybean certification standards identify land 

requirements and field practices that must be followed. Soybeans must be grown on land 

on which the previous crop grown was of a different type, certified seed of the same 

variety, or a variety having noticeable characteristic differences. In addition, for every 

200 certified soybean plants, only one off-type or other variety is allowed (AOSCA 

Moline, 2009). Certified seed crop is subject to field inspections by certifying agencies at 

harvest and other times in order to observe factors related to seed certification and 

determine genetic purity and identity. Harvested seeds may be inspected and sampled at 

any time (AOSCA Moline, 2009).
13

All soybean seed sold may not be officially certified; however, commercial soybean seed 

sold and planted for normal soybean production is produced predominately to meet or 

exceed certified seed standards.

2.1.4 Organic Soybean Production

In the U.S., only products produced using specific methods and certified under the 

USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) 

definition of organic farming can be marketed and labeled as “organic” (USDA-AMS, 

2010). Organic certification is a process-based certification, not a certification of the end 

product; the certification process specifies and audits the methods and procedures by 

which the product is produced.

In accordance with NOP, an accredited organic certifying agent conducts an annual 

review of the certified operation’s organic system plan and makes on-site inspections of 

the certified operation and its records. Organic growers must maintain records to show 

that production and handling procedures comply with USDA organic standards. 

The NOP regulations preclude the use of excluded methods. The NOP provides the 

following guidance under 7 CFR Section 205.105:

...to be sold or labeled as “100 percent organic”, “organic” or “made with organic 

(specified ingredients or group(s)),” the product must be produced and handled 

without the use of:...

(a) Synthetic substances and ingredients,...

(e) Excluded methods,...

Excluded methods are then defined at 7 CFR Section 205.2 as:

A variety of methods used to genetically modify organisms or influence 

their growth and development by means that are not possible under 

natural conditions or processes and are not considered compatible with 

organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA 

technology (including gene deletion, gene doubling, introducing a foreign 

gene, and changing the positions of genes when achieved by recombinant 

DNA technology). Such methods do not include the use of traditional 

breeding, conjugation, fermentation, hybridization, in vitro fertilization, 

or tissue culture.

Organic farming operations, as described by the NOP, are required to have distinct, 

defined boundaries and buffer zones to prevent unintended contact with excluded 

methods from adjoining land that is not under organic management. Organic production 

operations must also develop and maintain an organic production system plan approved 

by their accredited certifying agent. This plan enables the production operation to 

achieve and document compliance with the National Organic Standards, including the 

prohibition on the use of excluded methods. (USDA-AMS, 2010). 
14

Common practices organic growers may use to exclude GE products include planting 

only organic seed, planting earlier or later than neighboring farmers who may be using 

GE crops so that the crops will flower at different times, and employing adequate 

isolation distances between the organic fields and the fields of neighbors to minimize the 

chance that pollen will be carried between the fields (NCAT, 2003). Although the 

National Organic Standards prohibit the use of excluded methods, they do not require 

testing of inputs or products for the presence of excluded methods. The presence of a 

detectable residue of a product of excluded methods alone does not necessarily constitute 

a violation of the National Organic Standards (USDA-AMS, 2010). The current NOP 

regulations do not specify an acceptable threshold level for the adventitious presence of 

GE materials in an organic-labeled product. The unintentional presence of the products 

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

the operation has not used excluded methods and has taken reasonable steps to avoid 

contact with the products of excluded methods as detailed in their approved organic 

system plan (Ronald and Fouche, 2006; USDA-AMS, 2010). 

For 2008, the production of organic soybeans represented approximately 0.2% of U.S. 

soybean production. In 2005, 122,217 acres of soybean in the U.S. were certified 

organic, and in 2008, 125,621 acres were similarly certified (USDA-ERS, 2010b). In the 

five Atlantic Coastal states where MON 87701 is registered by EPA, organic soybean 

acreage in 2005 and 2008 was 921 acres and 894 acres, respectively (South Carolina and 

Georgia did not have any certifiable organic soybean production) (USDA-ERS, 2010b).

The production of organic soybeans represents about 0.13% of U.S. soybean production 

(USDA-NASS, 2011b). In 2008, 98,199 acres of certified or exempt organic soybean 

were harvested in U.S.

Organic soybean markets typically enjoy a market premium offsetting the additional 

production and record-keeping costs associated with this production method.

Table 3. Organic soybean production in seven U.S. states in 2008.

State1

Area harvested

organic 

soybean 

(acres)

Production

(bushel)

Percentage of 

total state 

soybean 

production area

Percent of 

U.S. organic 

soy 

production 

area

Georgia 215 5,300 0.05 0.2

Maryland 895 21,469 0.19 0.9

North Carolina 323 10,205 0.02 0.3

South Carolina ND ND -- ---

Virginia 387 12,275 0.07 0.4

Arkansas D D -- --

Illinois 6,342 210,952 0.07 6.5

Total 1,820 49,249 NA 8.3

ND = no data for this crop in this state in the USDA-NASS 2008 Organic Survey
15

D= data not disclosed in in the USDA-NASS 2008 Organic Survey to protect individuals privacy

Source: (USDA-NASS, 2009)

2.2 Physical Environment

2.2.1 Water Resources

Soybean production under irrigation in the Atlantic Coastal states represent 2 percent of 

the total U.S. irrigated soybean area, while the cultivation of soybeans grown under 

dryland conditions represent 7.8 percent of the total U.S. non-irrigated soybean area. 

Illinois represents about 2 percent of the irrigated soybeans in the U.S. and Arkansas 

accounts for 30 percent of the irrigated soybeans in the U.S.(USDA-NASS, 2007).

Irrigation is generally accepted as necessary to obtain higher yields (Boerma and Specht, 

2004). The high propensity for drought later in the growing season makes water less 

available during the essential reproductive period of the soybean, and the clay soil tends 

to become dry and crack (Rufty et al., 1993). Watering after planting is beneficial 

because it activates pre-emergence weeds immediately, therefore giving seedlings an 

advantage over weeds, and allows for amount of irrigation water used to depend on postplanting rainfall (Heatherly and Hodges, 1999). Although studies have shown that 

irrigation is most important during the reproductive period, water must also be provided 

during the vegetative period so plants have sufficient height to support reproduction 

(Boerma and Specht, 2004). Earlier-planting varieties can alleviate the stress of drought 

later in the season by coinciding the growing period with periods of higher rainfall 

(CAST, 2009; McPherson et al., 2001).

With respect to the effects of nutrient runoff on water resources, conservation tillage and 

no-till practice has been shown to minimize surface water runoff and soil erosion. By 

improving soil quality, the resulting increase in soil organic matter promotes the binding 

of nutrients, as well as pesticides and herbicides, to soil and prevents their loss to surface 

waters and groundwater from runoff, erosion, and leaching (Leep et al., 2003).

2.2.2 Soil Quality

Land used for growing crops supports a rich and complex community of below ground 

microorganisms and arthropods. The interaction between the below ground community, 

plant root structure, and organic residues in the soil is central to a variety of dynamic soil 

ecological processes, including the decomposition of organic material, nutrient cycling 

and release, and maintenance of soil structure and composition. 

Soybeans are grown on a variety of soil types, ranging from small particles (clay), 

medium particles (silt), and large particles (sand). Silt loam particles’ medium size, good 

aeration, fertility, high water-holding capacity and abundance of organic matter make it 

the ideal soil for soybean cultivation (Hoeft et al., 2000). Care must be taken to prevent 

overworking of silt loam, which can result in soil hardening and nutrient deficiency. 

Erosion is also a concern (Hoeft et al., 2000). The ideal pH for soybean growth is 6.0, 

with yield declining at a pH<5.8 (Heatherly et al., 2009; Hoeft et al., 2000). 

Disadvantages of clay soils include their tendency to clump and impede drainage when 
16

tilled at too low or too high moisture, leading to less aeration and a tendency toward 

erosion (Hoeft et al., 2000).

Mutualistic relationships with beneficial microorganisms are essential to soybean growth. 

Beneficial microorganisms include Rhizobium, gram-negative bacteria that fix 

atmospheric nitrogen and make it available to the soybean plant, and mycorrhizal fungi 

that attach to soybean roots and extend hyphae deep into the soil, effectively increasing 

soybean access to nutrients and water (Purves et al., 2004). In addition to increasing 

soybean access to water and nutrients, mycorrhizal hyphae also facilitates pore creation 

in soil through particle aggregation, an important effect in clay soils that do not aerate 

well (Heatherly and Hodges, 1999). Both Rhizobium and mycorrhizae aid plant survival 

during drought. Mycorrhizal-colonized non-irrigated soybeans have shown a 10 percent

increase in yield compared to non-colonized non-irrigated soybeans during a drought 

period. These two mutualistic symbioses have been shown to occur concurrently, with 

mycorrhizae having a positive impact on Rhizobium nodulation and the nitrogen-fixing 

activity of nodules present on the soybean plant. These soybean plants also provided a 

greater yield (Heatherly and Hodges, 1999). 

2.2.3 Air Quality 

Many agricultural activities affect air quality, including smoke from agricultural burning, 

tillage, traffic and harvest emissions, pesticide drift from spraying, and nitrous oxide 

(N2O) emissions from the use of nitrogen fertilizer (Aneja et al., 2009; Hoeft et al., 

2000). These agricultural activities individually have potentially adverse environmental 

impacts on air quality. Tillage contributes to the release of greenhouse gases (GHG) 

because of the loss of carbon dioxide (CO2) to the atmosphere and the exposure and 

oxidation of soil organic matter (Baker et al., 2005). Emissions released from agricultural 

equipment (e.g., irrigation pumps and tractors) include carbon monoxide, nitrogen 

oxides, reactive organic gases, particulate matter, and sulfur oxides (US-EPA, 2010b). 

Nitrous oxide may also be released following the use of nitrogen fertilizer (US-EPA, 

2010b). Aerial application of pesticides may cause impacts from drift and diffusion. 

Pesticides may volatilize after application to soil or plant surfaces and move following 

wind erosion (Vogel et al., 2008). Agriculture, including land-use changes for farming, is 

responsible for an estimated six percent of all human-induced GHG emissions in the U.S. 

N2O emissions from agricultural soil management are a large part of this, contributing 68

percent of all U.S. N2O emissions (US-EPA, 2010b). 

2.2.4 Climate Change

Climate change represents a statistical change in climate conditions, and may be 

measured across both time and space. Production of agricultural commodities is 

interrelated with climate change on several different levels (Dale, 1997; Rosenzweig and 

Parry, 1994). U.S. agriculture may act influence climate change through various facets of 

the production process. Combustion of fossil fuels in mechanized farm equipment, 

fertilizer application, and decomposition of agricultural waste products may all contribute 

greenhouse gases to the atmosphere. Greenhouse gases collectively function as retainers 

of solar radiation, and agriculture-related activities are recognized as both direct (e.g., 
17

exhaust from equipment) and indirect (e.g., agricultural-related soil disturbance) sources 

of CO2, methane (CH4), and N2O. The U.S. agricultural sector is identified as the 

second largest contributor to GHG emissions, ranking only behind the energy sector (i.e., 

electricity production, transportation, and related activities). Agricultural crop 

commodities may also affect dynamic geophysical soil processes, such as carbon 

turnover and sequestration, through tillage and cropping system practices. In general, 

reduced/conservation tillage practices favor more stable and increased carbon 

sequestration in the agro-environment (Lal and Bruce, 1999). Additionally, climate 

change may also affect agricultural crop production. These potential impacts on the agroenvironment and individual crops may be direct, including changing patterns in 

precipitation, temperature, and duration of growing season, or may cause indirect impacts 

influencing weed and pest pressure (Rosenzweig and Parry, 1994; Schmidhuber and 

Tubiello, 2007).

The impacts of GE crop varieties on climate change are unclear, though it is likely 

dependent on cropping systems, production practices, geographic distribution of 

activities, and individual grower decisions. APHIS will continue to monitor 

developments that may lead to possible changes in the conventional production system 

likely to result from GE products brought to APHIS for approval. The potential impact 

of climate change on agricultural output, however, has been examined in more detail. A 

recent IPCC forecast (IPCC, 2007) for aggregate North American impacts on agriculture 

from climate change actually projects yield increases of 5 to 20 percent for this century. 

The IPCC report notes that certain regions of the U.S. will be more heavily impacted 

because water resources may be substantially reduced. While agricultural impacts on 

existing crops may be significant, North American production is expected to adapt with 

improved cultivars and responsive farm management (IPCC, 2007). 

2.3 Biological Resources

This section provides a summary of the biological environment and includes an overview 

of animals, plants, gene transfer, weeds and weediness, microorganisms, and biodiversity. 

This summary provides the foundation to assess the potential impact to plant and animal 

communities, the potential for gene movement, and the potential for human health 

impacts. 

2.3.1 Animal Communities

Wildlife can be found in agricultural settings such as soybean fields. These animals may 

feed on soybean plants in the field and or make their homes in or near the margins of 

fields. White-tailed deer (USDA-APHIS, 2011a; Wallace et al., 1996) Canada geese, and 

other waterfowl (USDA-APHIS, 2011a) can feed on soybean, sometimes causing 

economic damage to the crop. In Georgia, feral hogs have also damaged soybean fields 

through rutting and feeding (USDA-APHIS, 2005). Rodents may also be found in 

soybean fields (Houtcooper, 1978). It is likely that reptiles and amphibians may also be 

found in soybean fields, especially if the habitat surrounding the field is suitable to 

support these types of animals.
18

Insects are considered less problematic than weeds in U.S. soybean production; 

nevertheless, insect injury can impact yield, plant maturity, and seed quality. 

Consequently, insect pests are managed during the growth and development of soybean 

to enhance soybean yield (Aref and Pike, 1998; Higley and Boethel, 1994). Insect injury 

in soybean seldom reaches levels that cause significant economic loss, as indicated by the 

low percentage (16%) of soybean acreage that receive insecticide treatments (USDANASS, 2007).

2.3.2 Plants Communities

The plant community surrounding a soybean field is dependent on geography. In certain 

areas, soybean fields can be bordered by other agricultural fields (including those of other 

soybean varieties), woodlands, or pasture and grasslands. From an agronomic 

perspective, the most relevant members of a surrounding plant community are those that 

can behave as weeds. Thus, weed pressure is also dependent on geography.

Annual weeds are perceived to be the greatest pest problem in soybean production, 

followed by perennial weeds (Aref and Pike, 1998). Weed control in soybean is essential 

to optimizing yields. Weeds compete with soybean for light, nutrients, and soil moisture. 

Weeds can harbor insects and diseases, and also can interfere with harvest, causing extra 

wear on harvest equipment (Loux et al., 2008). When weeds are left to compete with 

soybean for the entire growing season, yield losses can exceed 75% (Dalley, 2001).

Generally, the effects of competition increase with increasing weed density (Weiner et 

al., 2001). The time period that weeds compete with the soybean crop influences the level 

of yield loss. The later the weeds emerge, the less impact the weeds will have on yield. 

Soybean plants withstand early-season weed competition longer than corn as the soybean 

canopy closes earlier in soybean than in corn (Mallory-Smith and Zapiola, 2008). The 

extent of canopy closure regulates the availability of light to weeds and other plants that 

grow below the soybean. 

To combat weed problems in soybean, many growers have adopted herbicide resistant 

soybean varieties. USDA-ERS estimated that 93% of soybean growers have adopted 

herbicide resistant varieties of soybeans, indicating that these crops are the main system 

used to manage weeds in soybean fields (USDA-ERS, 2010a). 

2.3.3 Gene Flow and Weediness

Gene flow is a biological process that facilitates the production of hybrid plants, 

introgression of novel alleles (i.e., versions of a gene) into a population, and evolution of 

new plant genotypes. Gene flow to and from an agro-ecosystem can occur on both 

spatial and temporal scales. In general, plant pollen tends to represent the major 

reproductive method for moving across areas, while both seed and vegetative propagation

tend to promote the movement of genes across time and space. 

The rate and success of gene flow is dependent on numerous external factors in addition 

to the donor/recipient plant. General external factors related to pollen-mediated gene 

flow include the presence/abundance/distance of sexually-compatible plant species; 
19

overlap of flowering phenology between populations; the method of pollination; the 

biology and amount of pollen produced; and weather conditions, including temperature, 

wind, and humidity (Zapiola et al., 2008). Seed-mediated gene flow also depends on 

many factors, including the absence/presence/magnitude of seed dormancy; contribution 

and participation in various dispersal pathways; and environmental conditions and events. 

Soybean is not native to the U.S. and there are no feral or weedy relatives. Soybean is a 

self-pollinated species, propagated by seed (. 2000). Pollination typically takes place on 

the day the flower opens. The soybean flower stigma is receptive to pollen approximately 

24 hours before anthesis (i.e., the period in which a flower is fully open and functional) 

and remains receptive for 48 hours after anthesis. Anthesis normally occurs in late 

morning, depending on the environmental conditions. The pollen usually remains viable 

for two to four hours, and no viable pollen can be detected by late afternoon. Natural or 

artificial cross-pollination can only take place during the short time when the pollen is 

viable. As a result, soybean is considered to be a highly self-pollinated species, with 

cross-pollination to adjacent plants of other soybean varieties occurring at a very low 

frequency (0 to 6.3 percent) (Caviness, 1966; Ray et al., 2003; USDA-APHIS, 2011a; 

Yoshimura et al., 2006). 

2.3.4 Microorganisms

Soil microorganisms play a key role in soil structure formation, decomposition of organic 

matter, toxin removal, nutrient cycling, and most biochemical soil processes (Garbeva et 

al., 2004). They also suppress soil-borne plant diseases and promote plant growth (Doran 

et al., 1996). The main factors affecting microbial population size and diversity include 

soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient content), 

plant type (providers of specific carbon and energy sources into the soil), and agricultural 

management practices (crop rotation, tillage, herbicide and fertilizer application, and 

irrigation) (Garbeva et al., 2004). Plant roots, including those of soybeans, release a 

variety of compounds into the soil creating a unique environment for microorganisms in 

the rhizosphere. Microbial diversity in the rhizosphere may be extensive and differs from 

the microbial community in the bulk soil (Garbeva et al., 2004). 

2.3.5 Biodiversity

Biodiversity refers to all plants, animals, and microorganisms interacting in an ecosystem

(Wilson, 1988). Biodiversity provides valuable genetic resources for crop improvement 

(Harlan, 1975) and also provides other functions beyond food, fiber, fuel, and income. 

These include pollination, genetic introgression, biological control, nutrient recycling, 

competition against natural enemies, soil structure, soil and water conservation, disease 

suppression, control of local microclimate, control of local hydrological processes, and 

detoxification of noxious chemicals (Altieri, 1999). The loss of biodiversity results in a 

need for costly management practices in order to provide these functions to the crop

(Altieri, 1999). 

The degree of biodiversity in an agroecosystem depends on four primary characteristics: 

1) diversity of vegetation within and around the agroecosystem; 2) permanence of various 
20

crops within the system; 3) intensity of management; and 4) extent of isolation of the 

agroecosystem from natural vegetation (Southwood and Way, 1970). 

Agricultural land subject to intensive farming practices, such as that used in crop 

production, generally has low levels of biodiversity compared with adjacent natural areas. 

Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, 

and harvest result limit the diversity of plants and animals (Lovett et al., 2003). 

Biodiversity can be maintained or reintroduced into agroecosystems through the use of 

woodlots, fencerows, hedgerows, and wetlands. Agronomic practices include 

intercropping (the planting of two or more crops simultaneously to occupy the same 

field), agroforestry, crop rotations, cover crops, no-tillage, composting, green manuring 

(growing a crop specifically for the purpose of incorporating it into the soil in order to 

provide nutrients and organic matter), addition of organic matter (compost, green manure, 

animal manure, etc.), and hedgerows and windbreaks (Altieri, 1999), as well the adoption 

of non-till soybean cultivation (Carpenter et al., 2002).

2.4 Human Health

Public health concerns surrounding crops genetically engineered to accumulate Bt focus 

primarily on human and animal consumption. Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), it is the responsibility of food and feed manufacturers to ensure 

that the products they market are safe and properly labeled. Food and feed derived from 

GE soybean must be in compliance with all applicable legal and regulatory requirements.

GE organisms for food and feed may undergo a voluntary consultation process with the 

FDA prior to release onto the market. Although a voluntary process, thus far all 

applicants who wish to commercialize a GE variety that will be included in the food 

supply have completed a consultation with the FDA. In a consultation, a developer who 

intends to commercialize a bioengineered food meets with the agency to identify and 

discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered 

food and then submits to FDA a summary of its scientific and regulatory assessment of 

the food (FDA, 2010b). FDA evaluates the submission and responds to the developer by 

letter BNF No. 119 (FDA, 2010a).

As noted by the National Research Council (NRC), unexpected and unintended 

compositional changes arise with all forms of genetic modification, including both 

conventional hybridizing and genetic engineering (NRC, 2004). The NRC also noted that 

at the time, no adverse health effects attributed to genetic engineering had been 

documented in the human population. Reviews on the nutritional quality of GE foods 

have generally concluded that there are no significant nutritional differences in 

conventional versus GE plants for food or animal feed (Faust, 2002; Flachowsky et al., 

2005).

Pesticides, including herbicides and insecticides, are used on most soybean acreage in the 

U.S., and changes in acreage, crops, or farming practices can affect the amounts and 

types of pesticides used and thus the risks to workers. Common farm practices, however, 

can mitigate exposure to pesticides by farm workers. Choosing from less toxic groups of 
21

insecticides to control soybean insects is a good common agricultural practice. 

Additionally, the use of specialized equipment can also reduce farm worker exposure to 

pesticides. For example, the majority of large pesticide application machinery used in 

Arkansas and Mississippi have an enclosed cab and air conditioning and workers apply 

most all the applications (National Information System for the Regional IPM Centers, 

2005a, 2005b). Producers are trained to use spray nozzles with the largest practical 

opening to minimize spray drift and mist and few injuries have occurred during the 

mixing, loading, or application of pesticides.

2.5 Animal Feed

Domestic animals may also be exposed to soybeans through their diet. Animal feed is the 

major product derived from soybean meal produced in the U.S. (USB, 2007). In 2009, 

approximately 39 million tons of soybean meal was produced, 27 million tons of 

which was marketed for animal feed, with the largest volumes consumed by poultry 

(48%), swine (26%), and beef (12%). In 2009, 13 million metric tons of meal was used 

in poultry rations, with 7.0 and 3.3 million tons in hog and beef rations, respectively

(SoyStats, 2010a, 2010b).

Similar to the regulatory control for direct human consumption of soybean under the 

FFDCA, it is the responsibility of feed manufacturers to ensure that the products they 

market are safe and properly labeled. Feed derived from GE soybean must comply with 

all applicable legal and regulatory requirements, which in turn protects human health. To 

help ensure compliance, GE organisms used for feed may undergo a voluntary 

consultation process with FDA before release onto the market, which provides the 

applicant with any needed direction regarding the need for additional data or analysis, 

and allows for interagency discussions regarding possible issues. 

Although a voluntary process, thus far all applicants who wish to commercialize a 

GE variety that will be included in the food supply have completed a consultation 

with the FDA. In a consultation, a developer who intends to commercialize a 

bioengineered food meets with the agency to identify and discuss relevant safety, 

nutritional, or other regulatory issues regarding the bioengineered food and then 

submits to FDA a summary of its scientific and regulatory assessment of the food

(FDA, 2010b). FDA evaluates the submission and responds to the developer by letter

(FDA, 2010a). 

2.6 Socioeconomic

2.6.1 Domestic Economic Environment

Soybean is one of the most important crops in the U.S., being used for both animal feed 

and human consumption (Heatherly et al., 2009). Soybeans are an important source of 

protein and oil, contributing to food products such as soy milk, protein bars, and tofu 

(Monsanto, 2010). Once the oils have been extracted, soybean meal is used as animal 

feed (Monsanto, 2010). Currently, the U.S. produces approximately 38 percent of the 

global soybean supply (ASA, 2010). In 2010, 77.4 million acres of soybeans were 
22

planted in 31 states, with a yield of 3.33 billion bushels and a value of 38.9 million 

dollars (USDA-NASS, 2011a, 2011b). In the Atlantic Coastal states where soybeans are 

grown, yield losses from insects can sometimes reach economic thresholds. Early 

planting beginning in early April to control these pests, as well as avoiding the midsummer droughts and wet falls common in Southern states, are established practices 

(McPherson et al., 2001).

Soybean oil is an important source of vegetable oil, while soybean protein is commonly 

found in foods and animal feeds. The soybean industry comprises the businesses that sell 

seed to growers, the growers and their operations, and those that purchase the seed and 

crush, process and sell the basic products of seed, oil and meal, to the next set of soybean 

users. The further purchasers are animal feed producers, oil users in food and industrial 

sectors, and manufacturers of products such as biodiesel oil.

Soybean meal is the most important product deriving from soybean seed and meal is the 

product that drives demand for soybean rather than oil. Oil comprises only 19 percent by 

weight of the soybean (Tyson et al., 2004). Soybean meal is predominantly fed to 

animals (98 percent of production), while about 2 percent is used for human consumption 

or industrial uses (USB, 2007). The total U.S. seed market is estimated to be $12 billion, 

with a great proportion of this (23 percent) represented by soybean seed (Roucan-Kane 

and Gray, 2009).

2.6.2 Trade Economic Environment

Soybeans grown in the U.S. are exported throughout the world with exports rising 

steadily. In 2005, U.S. exported soybean was valued at $6 billion. In 2010, the value had 

risen to $18 billion. The majority of the soybean exported is not for replanting, but is 

sold as a commodity. Soybean seed for replanting was valued at $8 million dollars in 

2005 and has grown to about $27 million in 2010 (USDA-FAS, 2011). Therefore,

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

exported soy market. 

Intermittently, some of the Atlantic Coastal states have exported soybeans to South 

America, ranging from $3,045 (Maryland, 2007) to more than $9 million (Georgia, 2009)

(USDA-FAS, 2011). However, the database does not track whether this soybean was 

sold as seed for planting or for other uses. Illinois and Arkansas export more soybean to 

South America than the Atlantic Coastal states. Illinois has a high of nearly $7 million in 

2008 with most of that exported to Columbia, and Arkansas exported about $300 

thousand in 2009, with the majority of that soy being exported to Argentina. Again this 

is total soybean exports to South America from these states it is not possible to determine 

the quantity used for planting. 

Only a small amount of the soybean seed exported for planting is sent to South America, 

which is the main market for MON 87701 seed. Chile and Argentina have consistently 

imported the majority of this seed. Figure 3 shows the value of soybean seed exported 

for planting to South America between 2005 and 2010. The value of this export crop 

ranged from a low of $200,000 in 2006 to a high of just over $1 million in 2009. The 
23

average amount of soybean seed for planting exported to South America is approximately 

460 metric tons a years. However, the amount imported varies dramatically from year to 

year and country to country (USDA-FAS, 2011). In most years, this seed would account 

for planting less than 20,000 acres of soybeans in South America. Due to the small 

quantities, it is likely that much of this seed is imported as seed to breed commercial seed 

not as seed to be planted directly for commercial use.

 

World-wide, U.S. soybean seed planted for export ranges from 13,000 metric tons (2005) 

to 32,000 metric tons (2008). The majority of soybean seed exports are to other countries 

in North America (see Figure 4). Exports to South America account for only about 2% of 

the total soybean seed for planting exports (USDA-FAS, 2011). MON 87701 is approved 

for importation and environmental release in Brazil (BCH, 2010). Therefore, seed could 

be exported to Brazil for planting.

Figure 3: Value of U.S. soybean exports to South America, 2005-2010.

Source: (USDA-FAS, 2011).

Note: Currently, soybean seeds for planting are a minor part of the total U.S. soybean exports. 

Between 2005-2010 Chile and Argentina were the largest importers in this region of U.S. soybean 

seed for planting. 
24

Figure 4. Average soybean seed exports, 2005-2010.

Source: (USDA-FAS, 2011).

North America

40%

East Asia

33%

European 

Union-27

21%

Southeast Asia

3%

South America

2%

other regions

1%

Average Soybean Seed Exports, 2005-2010 
25

3 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of Monsanto Company MON 87701 soybean. To respond favorably 

to a petition for nonregulated status, APHIS must determine that MON 87701 is unlikely 

to pose a plant pest risk. Based on its PPRA (USDA-APHIS, 2011a), APHIS has 

concluded that MON 87701 is unlikely to pose a plant pest risk. Therefore APHIS must 

determine that MON 87701 is no longer subject to 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act. 

Two alternatives are evaluated in this EA: (1) no action and (2) determination of 

nonregulated status of MON 87701. APHIS has assessed the potential for environmental 

impacts for each alternative in the Environmental Consequences section.

3.1 No Action Alternative: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. MON 87701 soybeans 

and progeny derived from MON 87701 soybeans 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 of MON 87701 soybeans 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 of MON 87701 soybeans. 

This alternative is not the Preferred Alternative because APHIS has concluded through a 

Plant Pest Risk Assessment that MON 87701 soybeans is unlikely to pose a plant pest 

risk (USDA-APHIS, 2011a). Choosing this alternative would not satisfy the purpose and 

need of making a determination of plant pest risk status and responding to the petition for 

nonregulated status. 

3.2 Preferred Alternative: Determination that MON 87701 Soybean Is No Longer 

a Regulated Article

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

regulated articles under the regulations at 7 CFR part 340. MON 87701 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 of MON 87701 

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 is unlikely to pose a 

plant pest risk, a determination of nonregulated status of MON 87701 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.

Under this alternative, growers may have future access to MON 87701 and progeny 

derived from this event if the developer decides to commercialize MON 87701. 
26

3.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for MON 87701. The 

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

provisions of the 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 considered for MON 87701. Based on this evaluation, APHIS rejected several 

alternatives. These alternatives are discussed briefly below along with the specific 

reasons for rejecting each.

3.3.1 Prohibit Any MON 87701 from Being Released

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

marketplace, APHIS considered prohibiting the release of MON 87701, 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 is 

unlikely to pose a plant pest risk (USDA-APHIS, 2011a).

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 the Plant Pest Risk Assessment (USDA-APHIS, 2011a) and the scientific data 

evaluated therein, APHIS concluded that MON 87701 is unlikely to pose a plant pest 

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

3.3.2 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 lines described in 

a petition. Because APHIS has concluded that MON 87701 is unlikely to pose a plant 
27

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. 

3.3.3 Isolation Distance between MON 87701 and Non-GE Soybean Production 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 from 

conventional or specialty soybean production. However, because APHIS has concluded 

that MON 87701 is unlikely to pose a plant pest risk (USDA-APHIS, 2011a), an 

alternative based on requiring isolation distances would be inconsistent with the statutory 

authority under the plant pest provisions of the Plant Protection Act and regulations in 7 

CFR part 340. 

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

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

MON 87701 soybeans under FIFRA. However, as presented in APHIS’ plant pest risk 

assessment for MON 87701, there are no geographic differences associated with any 

identifiable plant pest risks for MON 87701 (USDA-APHIS, 2011a). This alternative 

was rejected and not analyzed in detail because APHIS has concluded that MON 87701

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 of the 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 of the Plant Protection Act.

3.3.4 Requirement of Testing for MON 87701

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

commenters requested USDA to require and provide testing for GE products in non-GE 

production systems. APHIS notes there are no nationally-established regulations 

involving testing, criteria, or limits of GE material in non-GE systems. Such a 

requirement would be extremely difficult to implement and maintain. Additionally, 

because MON 87701 does not pose a plant pest risk (USDA-APHIS, 2011a), the 

imposition of any type of testing requirements is inconsistent with the plant pest 

provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and 

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for MON 87701 would not meet APHIS’ purpose and need 

to respond appropriately to the petition in accordance with its regulatory authorities. 
28

3.4 Comparison of Alternatives 

Table 4 presents a summary of the potential impacts associated with selection of either of 

the alternatives evaluated in this EA. The impact assessment is presented in Section 4 of 

this EA. 

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Meets Purpose and Need 

and Objectives No Yes

Unlikely to pose a plant 

pest risk

Satisfied through use of 

regulated field trials

Satisfied – risk assessment

(USDA-APHIS, 2011a)

Management Practices

Acreage and Areas of 

Soybean Production

Unlikely to influence current 

trends in production regions 

or acreage of soybean planted

Unchanged from No Action 

Alternative

Agronomic Practices

Cropping practices will remain 

the same as current practices for 

commercial soybean seed 

production

Unchanged from No Action 

Alternative

Pesticide Use

Pesticide use unlikely to 

change. May see a decrease in 

insecticide use on MON 87701 

soy - will depend on type of 

insect pest. Due to limited 

acreage will not change national 

or regional pesticide use.

Unchanged from No Action 

Alternative

Soybean Seed Production Unchanged Unchanged

Organic Soybean 

Production Unchanged Unchanged

Environment

Land Use MON 87701 is not expected to 

have any effect on land use

Unchanged

Water Resources MON 87701 is not expected to 

have any effect on water

Unchanged

Soil MON 87701 is not expected to 

have any effect on soil Unchanged

Air Quality MON 87701 is not expected to 

have any effect on air quality Unchanged

Climate Change

MON 87701 is not expected to 

have any effect on climate 

change

Unchanged
29

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Animals

MON 87701 is not expected to 

have any effect on vertebrate 

animals or most invertebrate 

animals. MON 87701 is toxic 

to certain lepidopteran insects. 

Those that feed directly on 

MON 87701 soybeans would be 

expected to die or have delayed 

growth. This is unlikely to 

affect insect populations due to 

the limited number acres and 

the patchy distribution of these 

fields on the landscape.

Unchanged from the No 

Action Alternative

Plants MON 87701 is not expected to 

have any effect on plants Unchanged

Gene Movement

MON 87701 is not expected to 

have any effect on vertical or 

horizontal gene flow.

Unchanged

Soil Microorganisms

MON 87701 is not expected to 

have any effect on soil 

microorganisms.

Unchanged

Biological Diversity

MON 87701 is not expected to 

have any effect on biological 

diversity.

Unchanged

Human and Animal Health

Risk to Human Health MON 87701 does not have 

adverse human health effects Unchanged

Risk to Animal Feed

MON 87701 does change the 

nutritional qualities of animal 

feed.

Unchanged

Socioeconomic 

Domestic Economic 

Environment Unchanged Unchanged

Trade Economic 

Environment

May increase soybean seed for 

planting exports to some 

markets

May increase soybean seed 

for planting exports to some 

markets

Other Regulatory Approvals
30

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

U.S.

FDA completed 

consultations, EPA tolerance 

exemptions and conditional 

pesticide registrations granted

FDA completed 

consultations, EPA 

tolerance exemptions and 

conditional pesticide 

registrations granted

South America Brazil Brazil

Compliance with Other Laws

CWA, CAA, EOs Fully compliant Fully compliant
31

4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential environmental consequences addresses the potential impact to 

the human environment from the alternatives analyzed in this EA, namely taking no 

action and a determination by the agency that MON 87701 does not pose a plant pest 

risk. Potential environmental impacts from the No Action Alternative and the Preferred 

Alternative for MON 87701 are described in detail throughout this section. A cumulative 

effects analysis is presented for each potentially affected environmental concern. Certain 

aspects of this product and its cultivation would be no different between the alternatives: 

those instances are described below.

4.1 Scope of Analysis

MON 87701 is regulated in part by FIFRA, due to characterization of the Cry1Ac protein 

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

breeding and seed increase activities in the states of Georgia, South Carolina, North 

Carolina, Virginia, Maryland (US-EPA, 2010a) Illinois, Arkansas and the 

Commonwealth of Puerto Rico (U.S. EPA, 2011). This registration is limited to 15,000 

total acres in the specified Atlantic Coastal states, with production limited to 1,000 acres 

per county. In Illinois and Arkansas production is limited to 300 acres in each state. In 

the Commonwealth of Puerto Rico, the acreage is limited to 1000 acres in each 

municipio. Commercial sale of MON 87701 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 for seed production in Georgia, South Carolina, North Carolina, Virginia, 

and Maryland (US-EPA, 2010a) as well as Illinois, Arkansas and the Commonwealth of 

Puerto Rico (U.S. EPA, 2011). 

Potential environmental impacts from the No Action Alternative and the Preferred 

Alternative for MON 87701 soybeans are described in detail throughout this section. An 

impact would be any change, positive or negative, from the existing (baseline) conditions 

of the affected environment (described for each resource area in Section 2.0). Impacts 

may be categorized as direct, indirect, or cumulative. A direct impact is an effect that 

results solely from a proposed action without intermediate steps or processes. Examples 

include soil disturbance, air emissions, and water use. An indirect impact may be an 

effect that is related to but removed from a proposed action by an intermediate step or 

process. Examples include surface water quality changes resulting from soil erosion due 

to increased tillage, and worker safety impacts resulting from an increase in herbicide 

use. 

A cumulative effects analysis is also included for each environmental issue. A cumulative 

impact may be an effect on the environment which results from the incremental impact of 

the proposed action when added to other past, present, and reasonably foreseeable future 

actions. Examples include breeding MON 87701 with other events that are no longer 

subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340 or the 

potential commercialization of MON 87701 in the U.S. beyond current EPA-approved 

breeding and seed multiplication activities. If there are no direct or indirect impacts 
32

identified for a resource area, then there can be no cumulative impacts. Cumulative 

impacts are discussed in Section 5.

Where it is not possible to quantify impacts, APHIS provides a qualitative assessment of 

potential impacts. Certain aspects of this product and its cultivation may be no different 

between the alternatives; those are described below. 

4.2 Agricultural Production of Soybean

4.2.1 Acreage and Area of Soybean Production

No Action Alternative: Acreage and Area of Soybean Production

Under the No Action Alternative, MON 87701 would continue to be regulated by 

APHIS. Under APHIS notification, MON 87701 seed may still be produced for export. 

Additionally, MON 87701 would also continue to be registered by the EPA under a seed 

increase registration. As dictated by the EPA seed increase registration, MON 87701 

acreage is not to exceed 15,000 total cropland acres in the specified five Atlantic Coastal 

states, as well as the Commonwealth of Puerto Rico, with acreage limited to 1,000 acres 

per county within those states or municipio in Puerto Rico. Additionally, part of the 

15,000 acres could include 300 acres grown each in Arkansas and Illinois. 

It is expected that the 15,000 acres of MON 87701 soybeans would be planted on land 

currently used for agriculture. Under the No Action Alternative, cultivation of MON 

87701 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, 2011a). Due to planting restrictions defined by the EPA seed increase 

registration, cultivation of MON 87701 would remain a small percentage of total soybean 

cultivation area and would have no impact on current and projected land use patterns in 

the areas where it is labeled for use.

Preferred Alternative: Acreage and Area of Soybean Production

Under the Preferred Alternative, the planting of MON 87701 would be limited by the

EPA seed increase registration, but not regulated by APHIS. The restrictions placed on

MON 87701 cultivation range and acreage would be unchanged compared to the No 

Action Alternative. Thus, the impact on current and projected acreage under the

Preferred Alternative is the same as under the No Action Alternative.

4.2.2 Agronomic Practices

No Acton Alternative: Agronomic Practices

Under the No Action Alternative, MON 80771 could be produced under APHIS 

notification (7 CFR 340.3). Growers could produce soybean for seed exports in the states 

and counties identified by EPA in the seed increase registration. While the performance 

requirements in the regulations will need to be followed, these requirements are not 

inconsistent with the production of high quality seed. Therefore, it would be possible to 
33

raise MON 87701 soybeans on the scale allowed in the EPA registration under APHIS 

notification. Production of these soybeans would occur in agricultural areas where 

soybeans are typically cultivated. 

It is expected that similar agronomic practices that are currently used for commercially 

available soybean seed production will also be used by growers of MON 87701. 

Conventional soybean methods of production including tillage, fertilizer application, 

cultivation, fertilization, pesticide applications, and the use of agricultural equipment 

would be utilized. 

Planting of MON 87701 in these seven states and Puerto Rico may locally reduce the 

amount of insecticides applied to control lepidopteran pests. However, pesticides are only 

applied when insect pressures reach economic thresholds, since soybean plants tolerate 

large amounts of defoliation without effecting yield. In Virginia and North Carolina, 23 

and 22 percent of the soybean acres received insecticide treatments, respectively (USDANASS, 2007). These two states were the only Atlantic Coastal states for which survey 

data is available. In Arkansas 7 percent and in Illinois 2 percent of the soybean acres 

received insecticide treatments. Insecticide usage on soybeans in these North Carolina 

and Virginia are higher than the national average. According to the Virginia Cooperative 

Extension, the corn earworm is the most damaging pest in Virginia soybean fields 

(Herbert et al., 2009). MON 87701 would likely be effective for controlling these 

populations in any seed field where it is planted. This 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 87701 would have no effect on those insects. Because 

the fields are not a large component of the agricultural landscape (less that 1% of the total 

soybean acreage), planting MON 87701 will not have an effect on pest populations or 

application of insecticides to control insect pests.

MON 87701 will likely be conventionally crossed with nonregulated GE herbicide 

resistant soybean varieties to create new varieties to target both lepidopteran and weed 

pressure. 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). 

There are no expected increases in pesticide use for weed or pest management, 

harvesting, or volunteer control compared to currently-available soybean varieties. The 

proportion of soybean acreage that can be dedicated to MON 87701 cultivation represents 

0.1 percent of soybean production in states where this product can be grown, suggesting 

that any decrease in use of insecticides targeting lepidopteran pests is also unlikely to be 

significant relative to the overall amounts applied in this region. 

Preferred Alternative: Agronomic Practices

Under the Preferred Alternative, the planting of MON 87701 would continue to be 

limited by the EPA seed increase registration, but would not be regulated by APHIS. The 

amount and distribution of MON 87701 would be expected to remain the same as under 

the No Action Alternative due to the restrictions placed on MON 87701 cultivation range 
34

and acreage by the EPA seed increase registration. Therefore, there would be no change 

in agronomic practices under the Preferred Alternative compared to the No Action 

Alternative, due to similar agronomic practices that would be adopted under both 

alternatives.

4.2.3 Soybean Seed Production

No Acton Alternative: Soybean Seed Production

Management practices for the production of high quality seed would be used. These 

management practices include following AOSCA standards for the production of soybean 

seed of the desired class. Land use requirements and restrictions on other crops 

cultivated specified by AOSCA or state certifying agencies would be followed. Isolation 

distances beyond those needed to prevent mechanical mixing are not prescribed in the 

AOSCA standard (AOSCA Moline, 2009). 

Preferred Alternative: Soybean Seed Production

Under the Preferred Alternative, planting of MON 87701 would continue to be limited by 

the EPA seed increase registration, but would not be regulated by APHIS. Management 

practices and seed standards for production of Certified soybean seed would continue to 

be the same as for the No Action Alternative. 

4.2.4 Organic Soybean Production

No Action Alternative: Organic Soybean Production

The availability of soybean seed developed for organic production is expected to remain 

the same under the No Action Alternative. Under this alternative, MON 87701 soybean 

would continue to be regulated articles under the regulations at 7 CFR part 340. 

Additionally, MON 87701 would still be subject to the conditions in the EPA seed 

increase registration. Due to these conditions, MON 87701 acreage cannot exceed 

15,000 acres and is limited in planting to no more than 1,000 acres per county in Georgia, 

South Carolina, North Carolina, Virginia, Maryland and Puerto Rico (municipio). As part 

of the 15,000 acres 300 acres may be planted in both Arkansas and Illinois. Relative to 

the approximate 15.5 million acres of soybeans harvested in these seven states and Puerto 

Rico, MON 87701 may represent up to 0.09 percent of total soybean acreage. The 

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

(USDA-ERS, 2010a), 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 1percent of the soybeans 

grown in this state.

Due to the large proportion of GE soybean already grown in these states and the small 

amount of organic soybean production present, it is unlikely that MON 87701 and the 

limited amount of organic soybeans grown in these states will be in proximity of each 

other. Additionally, as discussed in Section 2.3.3, soybean is considered to be a highly 
35

self-pollinated species, with cross-pollination to adjacent plants of other soybean varieties 

occurring at a very low frequency (0 to 6.3 percent) (Caviness, 1966; Ray et al., 2003; 

USDA-APHIS, 2011a; Yoshimura et al., 2006). Therefore, it is unlikely that MON 87701 

cultivation will increase the likelihood of finding a GE off type in organic seed. 

It is important to note that the current NOP regulations do not specify an acceptable 

threshold level for the adventitious presence of GE materials in an organic-labeled 

product. The unintentional presence of the products of excluded methods will not affect 

the status of an organic product or operation when the operation has not used excluded 

methods and has taken reasonable steps to avoid contact with the products of excluded 

methods as detailed in their approved organic system plan (Ronald and Fouche, 2006; 

USDA-AMS, 2010). However, certain markets or contracts may have defined thresholds 

(Non-GMO-Project, 2010).

Preferred Alternative: Organic Soybean Production

Under the Preferred Alternative, the impact of a determination of nonregulated status of 

MON 87701 on organic soybean production would not differ from the No Action 

Alternative. As with the No Action Alternative, MON 87701 would continue to be 

grown under EPA registration on limited acres in an area with little organic soybean 

production. Because of the limited acreage and the current high adoption rate of other 

GE soybean varieties, MON 87701 is not likely to impact organic soybean production 

any more than nonregulated GE soybeans already primarily cultivated in that region.

4.3 Physical Environment

4.3.1 Water Resources

Irrigation is the most important factor in soybean production because drought is the most 

damaging abiotic stress factor (CAST, 2009). The majority of the irrigated soybean 

acreage occur in the western Corn Belt and mid-southern regions of the U.S. (USDANASS, 2011b). A recent agricultural practice aiming to reduce water stress is early 

planting of early-maturing soybeans groups II-V. This practice avoids a large portion of 

the drought period during the most sensitive reproductive stages of this crop (CAST, 

2009). 

No Action Alternative: Water Resources

Under the No Action Alternative, MON 87701 production would be limited to the seven 

states and Puerto Rico where it is approved for regulated releases by APHIS and EPA. 

The majority of soybean acreage in these six of the seven states is not irrigated, and the 

use of MON 87701 in this region under the No Action Alternative is unlikely to change 

any water use requirements (USDA-NASS, 2011b). This is due both to the small planted 

acreage of MON 87701 and the similar agronomic properties of MON 87701 and 

conventional soybean.

In regard to water quality, planting of MON 87701 in these seven states and Puerto Rico 

may locally reduce the amount of insecticides applied to control lepidopteran pests. To 
36

the extent that MON 87701 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 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 87701 

would have no effect on those insects or the insecticide required to control those pests.

In addition, any benefits associated with planting of MON 87701 are limited by the

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

the agricultural landscape (less that 0.1% of the total soybean acreage), planting MON 

87701 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.

Preferred Alternative: Water Resources

Under the Preferred Alternative, MON 87701 would not be regulated by APHIS. 

However, MON 87701 would remain subject to the EPA seed increase registration that

limits cultivation to seven states and Puerto Rico. The total acreage of MON 87701 in 

these seven states cannot exceed 15,000 acres and 1,000 acres per county across these 

five states and Puerto Rico. Illinois and Arkansas are each limited to 300 acres for the 

whole state. Production of MON 87701 does not require any changes to standard 

soybean cultivation practices. A determination of nonregulated status of MON 87701 

will not change the use of irrigation practices in commercial soybean seed production. 

Additional volumes of water are not expected to be needed since the MON 87701 

soybeans are expected to simply replace some of the area (15,000 acres) already in use 

for soybean production. Due to both the limited cultivated acreage of MON 87701 and 

the similar agronomic properties between MON 87701 and conventional soybean, the 

impact on water resources associated with the Preferred Alternative would be no different 

than those for the No Action Alternative. 

Any changes in pesticide use would be restricted to local fields. MON 87701 will not 

change the overall pesticide use on more than 99% of the soybean acres in the allowed 

area. The consequences of the Preferred Alternative on water resources are the same as

for the No Action Alternative. 

4.3.2 Soil Quality

No Action Alternative: Soil Quality

Under the No Action Alternative, MON 87701 would remain regulated by APHIS and 

continue to be restricted in geographic cultivation and acreage under its EPA registration. 

Thus, potential environmental impacts regarding soil quality would be limited to areas

where MON 87701 is approved.

Due to the relatively small area that MON 87701 can be cultivated on in the seven states

and Puerto Rico, it is unlikely that MON 87701 would have any effect, negative or 
37

positive, on soil quality. Agronomic performance for MON 87701 and conventional 

soybean is similar, which suggests that agronomic practices will be no different between 

MON 87701 and any other conventional soybean variety. Thus, the no till/reduced 

tillage systems that have been adopted by soybean growers will likely continue and are 

likely to be used in the cultivation of MON 87701. Tillage serves a multitude of 

functions in soybean production such as soil compaction remediation, improvement of 

water movement capacity during seeding, and the incorporation of fertilizers and 

pesticides. Reduced tillage has been demonstrated to decrease soil erosion and these 

practices have also proved to save fuel costs to growers (. 2007). Non-till systems in 

soybeans can reduce soil erosion up to 94% while preventing water runoff and preserving 

this valuable resource (. 2007). 

Additionally, it is unlikely under the No Action Alternative that MON 87701 will 

negatively affect soil microbial populations that are generally associated with 

conventional soybean cultivation and generally responsible for maintaining soil quality. 

In particular, mutual symbiotic relationships between soybean and the Rhizobiaceae and 

Bradyrhizobiaceae are unlikely to be negatively affected. While MON 87701 produces 

the insecticidal protein, Cry1Ac, presence of these toxins have been demonstrated to have 

no negative effect on soil microbes (Baumgarte and Tebbe, 2005; Icoz, 2008; Lawhorn et 

al., 2009), soil-associated fauna (Al-Deeb et al., 2003; Oliveira et al., 2007; Priestley and 

Brownbridge, 2009; Saxena and Stotzky, 2001; Sun et al., 2007; Zeilinger et al., 2010; 

Zwahlen et al., 2003) [but see (Höss et al., 2008)] or on litter decomposition processes 

(Zurbrügg et al., 2010). 

Preferred Alternative: Soil Quality

Under the Preferred Alternative, MON 87701 would not be regulated by APHIS, but 

would still be subject to the current EPA registration terms and conditions. No changes 

to agronomic practices typically applied in the management of soybeans are required for 

cultivation of MON 87701. There are no expected increases in land acreage or increases 

in cultivation, planting, pesticide use, fertilizer use, harvesting, or volunteer control 

compared to what is currently planted. It is expected that similar agronomic practices 

that are currently used for commercially available soybean seed production will also be 

used by growers of MON 87701. The potential planting of MON 87701 in the seven

states and Puerto Rico may only cover 15,000 acres, 0.09% of the soybean acreage of 

these areas. The small size of these planting limits the footprint such that any effects 

would be local.

4.3.3 Air Quality

Air quality may be affected by a variety of agricultural-related activities, including smoke 

from agricultural burning, tillage, traffic and harvesting-related emissions, pesticide drift 

from spraying, and nitrous oxide emissions from the use of nitrogen fertilizers (Aneja et 

al., 2009; Hoeft et al., 2000). These agricultural activities individually have potentially 

adverse environmental impacts on air quality. Tillage contributes to the release of GHGs 

because of the loss of CO2 to the atmosphere and the exposure and oxidation of soil 

organic matter (Baker et al., 2005). Emissions released from agricultural equipment (e.g.,
38

irrigation pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic 

gases, particulate matter, and sulfur oxides. Aerial application of pesticides may cause 

impacts from drift and diffusion. Pesticides may volatilize after application to soil or 

plant surfaces and move following wind erosion (Vogel et al., 2008).

No Action: Air Quality 

Under the No Action Alternative, MON 87701 would continue to be regulated by APHIS 

and subject to its EPA seed increase registration that limits production to no more than 

15,000 acres total in seven states and Puerto Rico.

The agronomic practices associated with soybean cultivation would remain unchanged,

as MON 87701 has agronomic properties similar to conventional soybean. At present, 

the majority of U.S. soybean acreage is planted with herbicide-resistant soybean varieties

and have contributed to the increased adoption of reduced tillage and no-till systems (USEPA, 2010c). Because MON 87701 will likely be conventionally crossed with 

nonregulated GE herbicide resistant soybean varieties, conservation tillage strategies 

would likely be continued to be used over the 15,000 acres where MON 87701 is planted. 

Since MON 87701 expresses a lepidopteran-specific insecticidal protein, in individual 

fields where this soybean is planted, growers may not need to use an insecticide to 

control lepidopteran insect pests. However, if other orders of insect pests are present and 

causing economic damage to the field, growers may still need to treat with an insecticide. 

MON 87701 can only be planted on a small proportion of the total cropland available in 

the five previously mentioned Atlantic Coastal states. Therefore, the locations of MON 

87701 fields will be scattered in the environment. Even if the production of MON 87701 

led to insect control in an individual field, it is not likely to change the population of the 

pest insect within a region. Also, MON 87701 will account for less than 0.1 percent of 

the total soybean acreage in the areas where it is registered for planting. Therefore, there 

is likely to be no overall change in pesticide application or the corresponding effects on 

the air quality from pesticide use. Overall, there is not expected change to the air quality 

on a local, regional, or national level.

Preferred Alternative: Air Quality

Under the Preferred Alternative, planting of MON 87701 cannot exceed 15,000 acres in 

as specified under EPA registration. The distribution of MON 87701 under this 

alternative is expected to be similar to that under the No Action Alternative, due to the 

terms and conditions of its EPA registration. Cropping practices for MON 87701 are 

unlikely to be different than those used for conventional soybean. Thus, the 

environmental impact on air quality is anticipated to remain unchanged between the No 

Action and Preferred Alternatives. 

As described above, the use of insecticides on individual fields of MON 87701 could be 

less than that for conventional soybeans if infestations of lepidopteran pests are above 

economic thresholds. Because MON 87701 plantings are likely to be scattered on the 

landscape, they are not expected to affect pest populations in any region. There is no 
39

expectation that overall insecticide applications would change with the production of 

MON 87701 seed. More than 99% of the soybeans in the seven states (and Puerto Rico)

where MON 87701 can be grown will not contain this trait. Therefore, those soybeans 

will likely still be treated with insecticides, and thus require the equipment necessary for 

insecticide application like conventional soybean. Overall impacts are similar to the No 

Action Alternative. 

4.3.4 Climate Change

No Action Alternative: Climate Change

Under the No Action Alternative, environmental releases of MON 87701 would be under 

APHIS regulation. Due to the EPA registration constraints, MON 87701 can only be 

grown in seven states (Georgia, South Carolina, North Carolina, Virginia, Illinois, 

Arkansas,and Maryland) and Puerto Rico. The maximum acreage allowed in each 

county, municipio, or state would also likely be dispersed within the political boundry. 

APHIS may choose to limit the size of individual plots to ensure that confinement is 

maintained. 

In the U.S., there are 2.3 billion acres of land, of which, 440 million acres are cropland 

(19.5 percent) (USDA-ERS, 2005). Collectively, the 15,000 acres of allowed MON 

87701 production represents about 3/1000 of 1 percent of the croplands in the U.S. In the 

seven states (and Puerto Rico) where MON 87701 could be grown, there are 15.5 million 

acres of soybeans (USDA-NASS, 2011b). Thus, the 15,000 acres where MON 87701 

could be grown would account for about 0.09 percent of this soybean area.

MON 87701 soybeans would likely be managed similarly to other soybeans grown for 

seed. Herbicides would be used and insecticides used as needed. Some decrease in 

insecticide use could occur if lepidopteran pressures are high in a particular area. 

However, MON 87701 does not control insects like stink bugs, aphids, or beetles. So if 

these pests are infesting the MON 87701 field insecticides would still be used. 

Therefore, there is unlikely to be a measurable change in an agricultural practice that 

might affect climate change in these fields. Agronomic practices associated with soybean 

production such as tillage, cultivation, irrigation, pesticide application, fertilizer 

applications and use of agriculture equipment would continue on soybeans grown 

throughout the region. Therefore, there would be no change in agricultural activities that 

might contribute to climate change. 

Climate change may result in shifts of herbivorous insects to higher latitudes. There is 

evidence that insect diversity and vegetative consumption intensity increase with 

increasing temperature at the same latitude in the fossil record (Bale et al., 2002). How 

climate change will affect individual species of pest insects will depend on their 

physiology, feeding behavior, and overwintering strategies (Bale et al., 2002). In cases 

where climate change favors the expansion of the range of soybean pests, additional 

soybean acres may be treated with insecticides. If these pests are controlled by Cry1Ac, 

fields planted with MON 87701 may suffer less insect damage without the additional 

application of insecticides. However, other orders of insects are not controlled by this 
40

insecticidal protein. If these increase in number, or shift their ranges north, insecticide 

use may be necessary to control these insects in soybeans.

Preferred Alternative: Climate Change

A determination of nonregulated status for MON 87701 is not expected to change the 

footprint of MON 87701 when compared to the No Action Alternative; under both 

alternatives, soybean production is limited to 15,000 acres per EPA’s registration. The 

cultivation or agronomic practices, or agricultural land acreage associated with growing 

soybeans, is expected to have the same effect on climate change as the No Action 

Alternative.

4.4 Biological Resources

4.4.1 Animal Communities

No Action Alternative: Animal Communities

Under the No Action Alternative, MON 87701 would continue to be regulated by APHIS 

and subject to its EPA seed increase registration that limits production to a total of 15,000 

acres in seven states and Puerto Rico. 

Under the No Action Alternative, conventional and GE transgenic soybean production, 

including the use of MON 87701, will continue while MON 87701 remains a regulated 

article. Soybeans are currently produced in 31 states (with no data for Puerto Rico)

(USDA-NASS, 2011b), and under the No Action Alternative this range of production 

will remain unchanged. Potential impacts of GE and non-GE soybean production 

practices on non-target species would be unchanged. The use of insecticides, other than 

Bt crops, may affect non-target organisms including honey bees, soil invertebrates, or 

culturable microbial flora (US-EPA, 2005). A notable advantage of GE 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 Cry1Ac, are very specific for lepidoptera, other arthropods 

are not likely to be affected (van Frankenhuyzen, 2009).

Preferred Alternative: Animal Communities

APHIS has reviewed the data submitted by the applicant. Based on the information 

submitted, APHIS has concluded that the agronomic practices used to produce MON 

87701 soybeans will be the same as those used to produce other conventionally grown 

GE and non-GE soybeans. MON 87701 soybean production does not change land 
41

acreage or any cultivation practices for conventional, transgenic, or non-transgenic 

soybean production.

Plants that were genetically engineered to express the Cry proteins have a history of safe 

use in the U.S. Since the mid-1990s, corn and cotton lines that express these proteins 

have been commercialized without deleterious impacts on non-target organisms

(Mendelsohn et al., 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 

insecticides2 without significant impacts on the diversity of non-target insects (Cattaneo 

et al., 2006; Dively, 2005; Marvier, 2007; Naranjo, 2005; Naranjo, 2005b. ; Romeis et al., 

2006; Torres and Ruberson, 2006; Torres and Ruberson, 2005; Whitehouse et al., 2005). 

MON 87701 is expected to be similar with respect to the low potential harm to the 

environment. Because Cry1 receptors are not present in non-target birds and mammals

(Hofmann, 1988; Hofmann et al., 1988; Shimada et al., 2006a; Shimada et al., 2006b; 

Van Rie et al., 1990), this insecticidal protein is not expected to adversely affect nontarget invertebrates (other than lepidoptera) and vertebrate organisms (US-EPA, 2008c). 

Monsanto presented information about the effect that Cry1Ac 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 effects 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 al., 1997; Romeis et al., 2004; Romeis et al., 2006). 

Based on the above information, APHIS concludes that MON 87701 will have no adverse 

effects on non-target animals. Therefore, potential impacts of MON 87701 and its 

associated production practices on animal species would be similar to the No Action 

Alternative. 

4.4.2 Plant Communities

No Action Alternative: Plant Communities

Under the No Action Alternative, cultivation of MON 87701 would be under APHIS 

regulation. Plant species that typically inhabit soybean production systems will be 

managed through the use of mechanical, cultural, and chemical control methods. The 

landscape surrounding a soybean field varies depending on the region. In certain areas, 

 2 Broad spectrum insecticides are chemical insecticides which kill insects that are causing injury 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 proteins are specific for a narrow 

range of insects, use of Cry1Ac to control plant pests is recognized as being beneficial to the survival of 

non-target insects (US-EPA, 2008a). 
42

soybean fields may be bordered by other soybean (or any other crop) fields or may also 

be surrounded by woodland, rangelands, and/or pasture/grassland areas. These plant 

communities may be natural or managed plant habitats for the control of soil and wind 

erosion and/or serve as wildlife habitats.

Some plants are weeds and compete with soybeans for water, nutrients, light, and other 

growth factors (Hoeft et al., 2000). The types of weeds in and around a soybean field 

depend on the immediate area in which soybeans are planted. Those weed species will 

vary depending on the geographic region where soybeans are grown. According to 

Woodruff et al. (2010), giant ragweed, pigweed, morning glory, and smartweed are billed 

as the top four most troublesome weeds (Woodruff et al., 2010). 

Preferred Alternative: Plant Communities

In the event of a determination of nonregulated status of MON 87701, the risks to wild 

plants and agricultural productivity from weedy soybean populations are low, as

volunteer soybean populations can be easily managed (Carpenter et al., 2002). The effect 

of soybean production on plant communities is likely to be unchanged by the introduction 

of MON 87701. Overall impacts would be similar to the No Action Alternative.

4.4.3 Gene Flow and Weediness

No Action Alternative: Gene Flow and Weediness

Under the No Action Alternative, MON 87701 would be grown under APHIS regulatory 

authority. Conditions would be placed on the cultivation of MON 87701 by APHIS that 

would substantially limit gene movement to other soybean crops. Gene flow from current 

commercially available GE cultivars to non-GE soybean cultivars is expected to remain 

unchanged from the current conditions.

Preferred Alternative: Gene Flow and Weediness

APHIS evaluated the potential for gene introgression to occur from MON 87701 soybean 

to sexually compatible varieties and considered the possibility that such introgression 

would result in increased weediness. Monsanto provided measures of plant growth 

including; plant growth and development characteristics, seed germination parameters, 

pollen characteristics, and observations for plant-insect and plant-disease interactions and 

plant responses to abiotic stressors. The only significant difference between MON 87701 

and the non-transformed (i.e., control) soybean was found in the percentage of hard 

viable seed at 20oC (Table VIII-3 of the petition (Monsanto, 2010)). The observed 

variation in germination was small (0.0% for MON 87701 and 0.5% for the control 

soybean) and was not found under any other temperature regime that ranged between 10 

to 30oC. 

A measure of the reproductive capacity of plants that are propagated by seed, such as 

soybeans, is the number of seeds that are produced and the germination and viability of 

those seeds. Overall, MON 87701 produced similar percentages of viable seed when 
43

compared to controls. These results on growth characteristics and seed production and 

germination, indicate that the MON 87701 is not statistically significantly different than 

its comparators. There is no indication that MON 87701 possesses a selective advantage 

that would result in increased weediness. Therefore, MON 87701 lacks the ability to 

persist as a troublesome weed, and there would be no direct impact on current weed 

management practices for soybean cultivation.

Monsanto’s data found no significant difference in pollen morphology and viability from 

field grown MON 87701 soybean plants and other soybean varieties. The soybean is not 

identified as a weed in the U.S. (USDA-APHIS, 2011a). Soybeans are not frost tolerant, 

do not survive freezing temperatures, and do not reproduce vegetatively (. 2000; USDAAPHIS, 2011a).

Based on the above information, APHIS has concluded that a determination of

nonregulated status of MON 87701 soybean will not impact other soybean varieties 

through gene flow or introgression, nor would it present a greater risk of weediness or 

invasive characteristics (USDA-APHIS, 2011a). MON 87701 soybean is expected to 

have the same effect on gene movement as the No Action Alternative.

4.4.4 Microorganisms

No Action Alternative: Microorganisms

An essential part of soybean production is an adequate soil population of nodulationinducing bacteria. As noted in Section 4.3.2 (Soil Quality), these bacteria must be

supplied if a soybean crop has not been recently grown on the planted field. Although 

the bacteria persist for several years in soil, their numbers may not be sufficient to insure 

adequate nodulation (Bottomley, 1992). Various commercial sources of inoculants such 

as multiple strains of Bradyrhizobium can be spread in soybean fields around the time of 

planting, many with similar results (Beuerlein, 2005). From one season to the next, the 

inoculated bacteria in soil may change characteristics or phenotypes and diverge from 

traits expressed by the original culture (Farooq and Vessey, 2009).

GE crops that produce Bt toxins (corn and cotton) are known to produce exudates of Cry 

proteins that can be detected in the soil (Baumgarte and Tebbe, 2005; Dubelman, 2005.; 

Icoz, 2008; Saxena et al., 1999; Saxena and Stotzky, 2001; Sun et al., 2007). The 

presence of these toxins, ubiquitous in the soil under normal conditions, have not shown a 

negative effect on soil microbes (Baumgarte and Tebbe, 2005; Blackwood and Buyer, 

2004; Devare et al., 2004; Icoz, 2008; Lawhorn et al., 2009) or on litter decomposition 

processes (Zurbrügg et al., 2010). Therefore, the production of MON 87701 is not 

expected to have an effect on soil microbes.

Preferred Alternative: Microorganisms

A determination of nonregulated status of MON 87701 would not change the effects of 

planting MON 87701 on soil organisms when compared to the No Action Alternative. 

While Bt exudates can be found in the soil when GE crops that produce Bt toxins are 
44

grown, this has not had a negative effect on soil microbes in corn or cotton systems. 

Because soybeans have symbiotic relationships with Rhizobiaceae and 

Bradyrhizobiaceae, the petitioner examined the effect of MON 87701 soybeans on these 

organisms in controlled studies. No significant differences were detected between MON 

87701 and the control for each measured parameter, including nodule number, shoot total 

nitrogen (percent and mass), and biomass (dwt) of nodules, shoot material, and root 

material. (Monsanto, 2010) Therefore, the Preferred Alternative is unlikely to affect soil 

microorganisms including those that have symbiotic relationships with MON 87701 

soybeans.

4.4.5 Biodiversity

The use of broad-spectrum insecticides is one of the most severe constraints for 

biological diversity in crops (Croft, 1990). One of the benefits of Bt crops, and Bt cotton 

in particular, has been the reduction of broad-spectrum insecticide use during cotton 

production (Fernandez-Cornejo and Caswell, 2006). The use of GE cotton producing the 

Cry proteins has been shown to reduce the use of broad spectrum insecticides3 without 

significant impact on the diversity of non-target insects (Cattaneo et al., 2006; Dively, 

2005; Marvier, 2007; Naranjo, 2005; Naranjo, 2005b. ; Romeis et al., 2006; Torres and 

Ruberson, 2006; Torres and Ruberson, 2005; Whitehouse et al., 2005). 

The presence and release of Bt toxins from the aboveground and belowground parts of Bt 

plants may influence microbial diversity. Bt toxin has been found to be present in every 

major part of Bt plants (Sivasupramaniam et al., 2008). However, the presence of Bt 

toxin in the soil may not influence microbial diversity or activity. Studies on the effects 

of Bt on non-target soil microorganisms in Bt maize and Bt cotton cultivation found that 

microbial biodiversity and activity were no different than that of their non-Bt 

counterparts (Icoz, 2008; Shen et al., 2006).

No Action Alternative: Biodiversity

Under the No Action Alternative, MON 87701 and its progeny would continue to be 

regulated under 7 CFR part 340. Production of MON 87701 would be restricted to 15,000 

acres in five Atlantic Coastal states and no more than 1,000 acres of these soybeans could 

be grown in any county (US-EPA, 2010a). 

As described in Section 4.2, acreage and cultivation practices associated with soybean 

production would not be affected. Agronomic practices associated with conventional 

soybean production such as tillage, cultivation, irrigation, pesticide application, fertilizer 

applications and use of agriculture equipment would continue. No direct or indirect 

adverse effects have been reported for non-target organisms since the introduction of 

commercial varieties of Bt cotton and corn in 1996. Bt cotton now represents 60% of the 

 3 Broad-spectrum insecticides are chemical insecticides which kill insects that are causing injury 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 proteins are specific for a narrow 

range of insects, use of Cry1Ac to control plant pests is recognized as being beneficial to the survival of 

non-target insects (EPA 2008). 
45

cotton planted in the U.S (James, 2009) and Bt corn is about 20% of the corn acreage

(Glaser and Matten, 2003; Hutchison et al., 2010). Therefore, planting MON 87701 

soybeans is not expected to impact biodiversity. 

Preferred Alternative: Biodiversity

A determination of nonregulated status of MON 87701 will not change the cultivation or 

agronomic practices, or agricultural land acreage associated with growing soybeans. 

Potential impacts associated with Cry proteins are expected to be similar to the no action 

alternative. Therefore, this alternative will have the same effect on biological diversity as 

the No Action Alternative.

4.5 Human Health 

4.5.1 No Action Alternative: Human Health

Under the No Action Alternative, consumers are not expected to be exposed to MON 

87701 because it is not registered by EPA for commercial scale planting in the U.S. The 

EPA registration limits the production to breeding and seed increase activities to support 

export of MON 87701 to tropical and subtropical regions outside the U.S. and its 

territories (US-EPA, 2010a). 

MON 87701 is compositionally similar to currently available soybeans on the market 

with the exception of the Cry1Ac protein. Cry1Ac has an existing exemption from the 

requirement of a tolerance in food and feed commodities granted by EPA in 1997. The 

Cry1Ac has a history of safe use in cotton and corn products, is not toxic to humans, and 

is not likely to be an allergen (US-EPA, 1997, 2010a). Compositional tests conducted by 

the petitioner indicate that MON 87701 is compositionally similar to other commercially 

available soybeans (Monsanto, 2010). Fifteen analytes: alanine, 22:0 behenic acid, 

carbohydrates, daidzein, glycine, histidine, isoleucine, leucine, lysine, protein, serine, 

threonine, trypsin inhibitor, valine, and vitamin E were statistically different from the 

control varieties used in the study. The values for these analytes all fell within the range 

of commercially available soybean varieties (Monsanto, 2010). Therefore, MON 87701 is 

nutritionally indistinguishable from commercial soybeans. The consumption of this 

soybean variety will not affect human health differently than other soybean varieties. Soy 

typically contains about 50 percent protein by dry weight, and is the most important 

product of soybean production. A relatively small proportion of the soybean crop is 

consumed directly by humans and most domestic soybean meal is consumed by 

livestock.

The Monsanto Company initiated the consultation process with FDA for the commercial 

distribution of MON 87701 and submitted a safety and nutritional assessment of food and 

feed derived from MON 87701 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, 2010a). Based on the information the Monsanto Company 

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

87701 soybean.
46

Based on the FDA’s consultation, laboratory data and scientific literature provided by 

Monsanto (Monsanto, 2010), and safety data available on other Cry1Ac products, APHIS 

has concluded that MON 87701 would have no significant impacts on human health. 

 

As discussed in the agronomic practices section, most soybean fields are not treated with 

insecticides. Soybeans can tolerate large amounts of defoliation without affecting yield 

(UMD, 2009). Therefore, the number of acres treated for insects varies from year to year 

and may vary from state to state. The NASS chemical use survey from 2006 indicates 

that 16 percent of soybeans planted were treated with insecticides, with treated acres 

varying from 75 percent in Louisiana to 4 percent in Ohio (USDA-NASS, 2007). MON 

87701 soybeans only control lepidopteran pests, so treatments to control, thrips, stink 

bugs, and beetles would still need to be applied. MON 87701 only controls lepidopteran 

insects that feed on the plant directly. Soybeans in neighboring fields would still need to 

be treated if a lepidopteran pest had reached economic levels. Under the No Action 

Alternative, because the number of production acres is limited, very little change in 

current insecticide use patterns is expected, and, as a result, there is no expected change 

in farm worker exposure or health.

4.5.2 Preferred Alternative: Human Health

Under the Preferred Alternative, a determination of nonregulated status of MON 87701

by APHIS would not result in any differences in exposure to MON 87701 by consumers 

when compared to the No Action Alternative. Because MON 87701 and its progeny 

would continue to be regulated by EPA under 7 CFR part 340 for seed production, only, 

it is not expected that consumers will be exposed to this variety through food sources.

APHIS considers the FDA regulatory assessment in making its determination of the 

potential impacts of a determination on nonregulated status of the new agricultural 

product. The Monsanto Company initiated the consultation process with FDA for the 

commercial distribution of MON 87701 and submitted a safety and nutritional 

assessment of food and feed derived from MON 87701 to the FDA on May 28, 2009 

(BNF No. 000119) (FDA, 2010a). FDA evaluated the submission and responded to the 

developer by letter on August 18, 2010 (FDA, 2010b). Based on the information the 

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

regarding MON 87701 soybean.

For the reasons described, above, in the No Action Alternative, there is no expected 

change to worker health and safety from a determination of nonregulated status of MON 

87701. Based on the FDA’s consultation, laboratory data and scientific literature 

provided by Monsanto (Monsanto, 2010), and safety data available on other Cry1Ac 

products, APHIS has concluded that a determination of nonregulated status of MON 

87701 would have no significant impacts on human health. 
47

4.6 Animal Feed

The majority of the soybean cultivated in the U.S. is grown for animal feed, and is 

usually fed as soybean meal (USB, 2007). Under FFDCA, it is the responsibility of 

feed manufacturers to ensure that the products they market are safe and properly 

labeled. Feed derived from MON 87701 soybean must be in compliance with all 

applicable legal and regulatory requirements. GE organisms for feed may undergo a 

voluntary consultation process with the FDA prior to release onto the market.

The FDA has completed a consultation on the MON 87701 soybean. Monsanto 

submitted a summary of its safety and nutritional assessment of MON 87701 soybean to 

FDA on May 28, 2009 (FDA, 2010b). Monsanto has provided the FDA with information 

on the identity, function, and characterization of the genes, including expression of the 

gene products in MON 87701 soybean.

Monsanto analyzed the composition of forage and seed from the MON 87701 soybean 

and compared it to a non-transgenic soybean control variety, A5547 (control), which has 

a genetic background similar to MON 87701. Monsanto also evaluated the composition 

of forage and seed from a total of twenty commercial non-transgenic soybean varieties 

("reference varieties") grown under the same field conditions as MON 87701 and control 

soybeans. Monsanto used the data derived from the reference varieties to generate a 99% 

tolerance interval for each analyte. Monsanto states that these data illustrate the natural 

variability in commercially grown soybean varieties grown under similar field conditions. 

The compositional analysis included key nutrients and anti-nutrients (Monsanto, 2010).

No Action Alternative: Animal Feed

For the No Action Alternative, MON 87701 would be registered by EPA for seed 

production only. There would be no commercial scale planting of MON 87701 in the 

U.S., and MON 87701 soybean would not be used in animal feed. As a result, there 

would be no additional risks or benefits to livestock feed safety from MON 87701 under 

the No Action Alternative.

Preferred Alternative: Animal Feed

Under the Preferred Alternative, the planting of MON 87701 would be limited by the 

EPA seed increase registration, but not regulated by APHIS. Thus, the restrictions placed 

on the MON 87701 cultivation range and acreage would be unchanged compared to the 

No Action Alternative. There would be no commercial planting of MON 87701. 

Therefore, animals feed would not include MON 87701 and animals would not be

exposed to this variety through food sources.

APHIS considers the FDA regulatory assessment in making its determination of the 

potential impacts of a determination of nonregulated status of the new agricultural 

product. The FDA has completed its consultation on the MON 87701 soybean (FDA, 

2010a). Based on a review of composition and nutritional characteristics of MON 87701

soybean, the FDA has concluded that MON 87701 is not materially different in any 
48

respect relevant to feed safety compared to soybean varieties already on the market

(FDA, 2010a).

Based on this information APHIS has concluded that a determination of nonregulated 

status of MON 87701 soybean would have no significant impacts on animal feed or animal 

health. Overall impacts are similar to the No Action Alternative.

4.7 Socioeconomic Impacts

4.7.1 Domestic Economic Environment

No Action Alternative: Domestic Economic Environment

MON 87701 is registered by EPA only for seed production in seven states (Georgia, 

South Carolina, North Carolina, Virginia, Illinois, Arkansas, and Maryland) and Puerto 

Rico. It is not registered for large scale commercial planting. Given that it is not being 

grown for commodity use in the U.S., it will not have an effect on the U.S. domestic 

soybean market.

Preferred Alternative: Domestic Economic Environment

Under the Preferred Alternative, MON 87701 is not expected to have any different 

impacts from the No Action Alternative on the domestic soybean market. Although 

APHIS would not require permits or notification for the movement or release into the 

environment of this soybean under this alternative, its production is limited by its EPA 

registration.

4.7.2 Trade Economic Environment

No Action Alternative: Trade Economic Environment

The majority of exported soybean seed for planting is sold to other countries in North 

America. Only about 2 percent of this current market or about 460 metric tons are 

exported to South American countries. Growing MON 87701 on 15,000 acres could 

result in approximately 16,000 metric tons

4 of seed for export. This is a 35-fold increase 

in potential exports to this market. Brazil has already approved MON 87701 for import 

and planting. Based on the GATS database, soybean seed for planting is not currently 

exported to Brazil, so this could be a new market for soybean seed exports. Argentina 

and Chile, the countries that currently import the most soybean seed for planting, have 

not yet approved MON 87701. Because MON 87701 represents such a small portion of 

the total soybean seed production in the U.S., it will not impact the availability of other 

seed varieties that meet the current export needs. 

Preferred Alternative: Trade Economic Environment

 4 15,000 acres with an average yield of 40 bushels an acre (University of Missouri Extension, 1993) and 

60 lbs of soy per bushel (UK Cooperative Extension Service, 2005). Using 2204.623 lbs/ metric ton.
49

MON 87701 was developed for insect control in some South American markets. These 

countries have their own regulatory systems. To the extent that regulatory approval in

the country of origin facilitates regulatory approvals in destination markets, a 

determination of nonregulated status of MON 87701 could increase seed exports to some 

countries. Exports to South America are a minor part (2 percent) of the current soybean 

seed export market (see discussion in Section 2.4.2). Increases in exports to South 

American markets as the result of a determination of nonregulated status of MON 87701 

are not likely to change the current export amounts to other regions although it could 

increase the overall export of soybean seed. Soybean seed for planting is a minor part of 

the overall soybean export market. Even with the potential addition of new export 

markets, the contribution of MON 87701 to the overall soy export market is minor. 
50

5 CUMULATIVE IMPACTS

A cumulative impact may be an effect on the environment which results from the 

incremental impact of the proposed action when added to other past, present, and 

reasonably foreseeable future actions. For example, the potential effects associated with 

approval of nonregulated status for a GE crop in combination with the future production 

of crop seeds with multiple approved traits (i.e., “stacked” traits), including drought 

tolerance, herbicide tolerance, and pest resistance, would be considered a cumulative 

impact. 

5.1 Assumptions Used for Cumulative Impacts Analysis

MON 87701 soybean is currently registered for use by the EPA in five Atlantic Coastal 

states, Georgia, South Carolina, North Carolina, Virginia, and Maryland, with production 

being limited to a total of 15,000 acres in total. EPA further limits Mon 87701 to 1,000 

acres or less per county in each of these states. The current label also includes Puerto 

Rico with no more than 1000 acres per municipio, as well as Illinois and Arkansas both 

of which have limits of 300 in each state. The EPA registration is for seed increase, only,

and does not include the commercial sale of MON 87701 soybeans in the U.S. 

According to the petition, the intended use of this 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). 

Before selling MON 87701 seed in the U.S., Monsanto would be required to obtain a new 

registration from EPA to sell MON 87701 for commercial use in the U.S. If the developer 

decides to apply for an EPA Section 3 registration, which permits wide-scale commercial 

planting, EPA will determine the data requirements at that time. EPA has stated in the 

Biopesticide Registration Action Document (BRAD) that additional information on pest 

biology, dose, simulation modeling, and cross resistance would be necessary to assess the 

risks for an unlimited commercial registration of MON 87701 (US-EPA, 2010a).

In the event APHIS reaches a determination of nonregulated status of MON 87701

(Preferred Alternative), 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 soybeans beyond the currently 

allowable 15,000 acres. Therefore, the potential future expansion of MON 87701 acreage

in the U.S. is being considered as part of the cumulative impacts analysis.

GE soybeans currently are planted on the majority of soybean acres in the U.S. (93% of 

acreage in 2010) (USDA-ERS, 2010a). 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 would be combined with one or 

more nonregulated herbicide resistant events in the future (USDA-APHIS, 2011b). It also 

should be noted that because these commercially available herbicide resistant varieties of 

soybeans are no longer APHIS regulated, stacking of traits with MON 87701 may be 

done under either the No Action or Preferred Alternatives. Therefore, throughout the 

cumulative impacts section, APHIS will assume that MON 87701 will be combined with 
51

a commercially available herbicide resistant variety through conventional breeding 

methods. 

5.2 Cumulative Impacts: Acreage and Area of Soybean Production

If MON 87701 were to remain registered by the EPA for breeding and seed increase 

activities under the current terms and conditions, there would be no cumulative effect on 

current and projected land use patterns in those states. In the future, Monsanto may apply 

for an EPA commercial use registration for MON 87701. If approved by the EPA, MON 

87701 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 is broadly adopted

throughout the U.S (USDA-NASS, 2010).

It is likely that MON 87701 may be conventionally crossed with other GE soybean 

varieties that are not regulated pursuant to Part 340 and the Plant Protection Act, since 93 

percent of commercially planted soybeans in 2010 were genetically engineered to be 

herbicide resistant (USDA-ERS, 2010a). For example, 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 be commercialized in the U.S in areas 

where soybean experience both lepidopteran and weed pressure (USDA-APHIS, 2007). 

Neither the EPA approval of MON 87701 under a commercial use registration nor the 

crossing of MON 87701 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 is still a domesticated crop that cannot be 

cultivated outside areas of current agronomic management due to agricultural input 

requirements. Additionally, displacement of all currently adopted soybean varieties by 

MON 87701 and MON 87701 progeny is unlikely. At present, insecticides are used on 

only about 16 percent of soybean acres planted in the U.S. (USDA-NASS, 2007). Only a 

portion of these acres are managed for lepidopteran insect pests that MON 87701 protects 

against. Thrips, beetles, and stink bugs are also pests of soybeans (UMD, 2009) for which 

MON 87701 would not be effective against. Because soybeans can tolerate a large 

amount of defoliation, growers monitor fields and make management decisions based on 

the type of insect and the damage to the crop (Gouge et al., 2011). For many growers, in 

most years, they may not need to treat fields with insecticides at all. Therefore, these 

growers are not likely to adopt MON 87701 unless the cost difference between it and 

other varieties is negligible. 

Because of the high adoption rate of herbicide resistant soybeans already in the market 

place, it is unlikely that combining MON 87701 with these herbicide resistant varieties 

will result in increased adoption of herbicide resistant varieties, even if MON 87701 is 

marketed in the U.S. in the future.

Consequently, the cumulative effect on land use is likely to be minimal if commercial use 

registration of MON 87701 and conventional crossing with nonregulated GE soybean 

varieties were to occur, as these actions are unlikely to increase U.S. soybean acreage and 
52

the small proportion of U.S. soybean acres that is under significant lepidopteran insect 

pressure. 

5.3 Cumulative Impacts: Agronomic Practices

If MON 87701 were to remain registered by the EPA for breeding and seed increase 

activities in the seven states and Puerto Rico, there would be no expected cumulative 

effects on soybean agronomic practices, as cultivation of MON 87701 does not require 

any unique agronomic practices. 

There are two potential foreseeable future activities related to MON 87701 cultivation. 

First, Monsanto may apply for and be approved for an EPA commercial use registration 

for MON 87701. In contrast to the current MON 87701 seed increase registration, 

commercial use registration approval would permit MON 87701 to be commercially 

produced and sold across the U.S. Secondly, Monsanto may also cross MON 87701 with 

other commercially-available GE soybean varieties for commercialization in the U.S. An 

example would be the production of a soybean variety containing both nonregulated Bt 

and herbicide resistance traits, such as Ready2YeildTM soybean (product of a MON 

87701 and MON 89788 cross).

The potential approval of MON 87701 under a commercial use registration by EPA and 

generation of soybean varieties stacked with the MON 87701 and herbicide resistant 

events are unlikely to result in any cumulative effects on soybean agronomic practices. 

This is due to similar agronomic requirements between MON 87701 and conventional 

soybean and the reduced likelihood that MON 87701 will be adopted across all U.S. 

soybean acres. 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. Thrips, beetles, and stink bugs are also pests of soybeans. 

Because soybeans can tolerate a large amount of defoliation, growers monitor fields and 

make management decisions based on the type of insect and the damage to the crop. For 

many growers, in most years, they may not need to treat fields at all. Therefore, these 

growers are not likely to adopt MON 87701 unless the cost difference between it and 

other varieties is negligible. 

Certain areas experience much higher insect pressure than others. For example, in 

Louisiana in 2006, 75 percent of the soybean fields were treated with insecticides 

(USDA-NASS, 2007). Growers in soybean areas where lepidopteran pests result in the 

majority of insect damage may choose to adopt MON 87701. Adopters of this 

technology may reduce insecticide applications to MON 87701 soybean fields, when 

lepidopteran insect pressure is high. However, these growers will still need to monitor 

fields for insect damage and apply other insecticides, due to the presence of insect pests 

not affected by Cry1Ac that may cause damage to soybean. 

The states that might adopt MON 87701 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 of the total soybean acres of the U.S. It is 
53

unlikely that all of these acres would be converted to MON 87701 soybeans, because 

insect pressure is not uniform in all areas of a state. Therefore, it is likely that if MON 

87701 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 seed, the cost of insecticides, the likelihood of damage levels 

from lepidopteran pests that reach economic thresholds, and the price of soybeans. 

5.4 Cumulative Impacts: Soybean Seed Production

There would likely be no cumulative effect on seed production, as the management 

practices for the production of high quality seed would be the same under the No Action 

and Preferred Alternatives. These management practices include following AOSCA or 

state standards for the production of soybean seed of the desired class. 

5.5 Cumulative Impacts: Organic Soybean Production

If MON 87701 were to remain as currently registered by the EPA for breeding and seed 

increase activities, there would be no cumulative impacts on organic soybean production. 

Although MON 87701 could be bred with other nonregulated GE soybean varieties to 

produce a stacked variety (e.g., Bt and herbicide resistant soybean) under both APHIS

regulated and nonregulated status, there would be no cumulative impacts to organic 

soybean production due to the limited production acreage specified under the current 

EPA permit conditions. 

On a broader scale, if MON 87701 were to be granted a commercial use registration by 

EPA and if MON 87701 were to be stacked with other traits, such as herbicide resistance, 

then it is possible for MON 87701 to increase acreage beyond the previously approved 

cultivation area. However, as described before, it is unlikely that MON 87701 would be 

adopted and displace all of the currently-adopted soybean varieties. The states that might 

adopt MON 87701 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 18,829,000 acres, with organic soybean production totaling 19,301 

acres or 0.13 percent of total soybean cultivation (USDA-ERS, 2010b). Due to the small 

proportion of organic soybean production in the states likely to adopt MON 87701 if it 

were to become available commercially, it is unlikely that there would be any cumulative 

impacts from a determination of nonregulated status of MON 87701 by APHIS (Preferred 

Alternative) and any changes in its EPA registration. 

 

5.6 Cumulative Impacts: Water Resources

If MON 87701 were to remain registered by the EPA for breeding and seed increase 

activities in the seven statesand Puerto Rico, there would likely be no cumulative effect 

on water resources, as the impact of the No Action Alternative and the Preferred 

Alternative is similar across the seven states and Puerto Rico dictated by the EPA seed 

increase registration for MON 87701.
54

The potential approval of MON 87701 under a commercial use registration by EPA and 

generation of soybean varieties stacked with the MON 87701 and herbicide resistant 

events is also unlikely to have a cumulative effect on water resources over a larger range 

of cultivation beyond the five Atlantic coastal states previously described. It also does 

not result in a change in production practices that may indirectly affect water use or water 

runoff from agricultural fields. As discussed above, there may be a reduction in 

insecticide use on MON 87701 fields. However, it is not likely to change the effects of 

agricultural chemicals on surface or ground water because the individual fields will be 

dispersed among the larger landscape. In the future it is possible that the developer may 

seek an EPA registration that would allow planting on a larger area. As discussed above 

this area is likely to be in the southern U.S. were lepidopteran insect pressure reaches 

economic levels. It is possible that adoption of MON 87701 could result in fewer 

insecticide applications in these areas. However, it is unlikely that the magnitude of this 

change would impact surface or groundwater resources both because other insect 

pressure may still require insecticide applications and because insect pressure varies from 

year to year and location to location. Currently, insecticides are applied to few soybean 

acres, so the overall change in insecticide applications will be small. Therefore, there are 

no cumulative effects on water resources from the preferred alternative.

5.7 Cumulative Impacts: Soil Quality

If use of MON 87701 were to remain as currently specified under EPA registration, there 

would likely be no cumulative effect on soil quality, as the impact of the No Action 

Alternative and the Preferred Alternative is similar across the areas dictated by the EPA 

seed increase registration for MON 87701.

If, in the future, MON 87701 is granted a commercial use registration by the EPA, it may 

be cultivated across a larger area than the 15,000 acres where it is presently approved. 

Substitution of currently adopted soybean varieties with MON 87701 is unlikely across 

large swaths of soybean cultivation area due to the lack of lepidopteran insect pressure 

resulting in significant economic effects. Additionally, as discussed in Section 4.2.2, 

there are no anticipated changes in soil, as the use of tillage, agriculture equipment, 

irrigation, and fertilizer applications would not likely change as a result of a 

determination of nonregulated status of MON 87701. Therefore, even if MON 87701 

were to be commercialized in the future, the Preferred Alternative is not expected to 

contribute to increases of soil loss or degradation in comparison to the No Action 

Alternative, and, as a result, there are no expected cumulative impacts. 

5.8 Cumulative Impacts: Air Quality

If MON 87701 were to remain as currently registered by the EPA for breeding and seed 

increase activities, there is no expected cumulative effect on air quality resulting from a 

determination of nonregulated status, as the impact of the No Action Alternative and the 

Preferred Alternative would be the same across this five state region.

If in the future MON 87701 is granted a commercial use registration by the EPA, it may 

be cultivated across a larger area than the 15,000 acres where it is presently approved. 
55

However, adoption of MON 87701 across the entire U.S. soybean cultivation range is 

unlikely, as there may be a lack of large economic effect resulting from significant 

lepidopteran insect pressure. As previously discussed, the region most likely to adopt a 

soybean variety containing MON 87701 is the southern U.S. where lepidopteran insect 

pressure can reach economic levels. It is possible that adoption of MON 87701 could 

result in fewer insecticide applications in these areas. However, it is unlikely that the 

magnitude of this change would impact air quality, both because other insect pressure 

may still require insecticide applications and because insect pressure varies from year to 

year and location to location. Currently, insecticides are applied to few soybean acres, so 

the overall change in insecticide applications is expected to be small.

MON 87701 may be combined with nonregulated herbicide resistance traits, producing a 

soybean variety containing both traits. GE herbicide resistant soybeans already account 

for a majority of soybean acres in the U.S. (93% of acreage in 2010) (USDA-ERS, 

2010a). Stacking MON 87701 with GE herbicide resistant traits would not result in any 

changes to agronomic practices already used for currently cultivated soybeans. By 

combining the MON 87701 event with a nonregulated herbicide resistant trait, it is 

possible to continue adoption and utilization of reduced- or no till strategies in soybean 

cultivation, effectively mitigating the cumulative impact of this agronomic practice on air 

quality. Therefore, there are no cumulative effects on air quality from the Preferred 

Alternative. 

5.9 Cumulative Impacts: Climate Change

As discussed in Section 4.3.4, the Preferred Alternative will not result in any effects on 

climate change as compared to the No Action Alternative. While some agricultural 

practices can contribute to climate change through greenhouse gas emissions, these will 

not change as a result of a determination of nonregulated status of MON 87701 soybeans. 

Thus, if MON 87701 were granted an EPA commercial use registration that effectively 

permits an expansion in range or if MON 87701 were stacked with other nonregulated 

soybean varieties, there is unlikely to be a cumulative impact to climate change because 

of the lack of significant effects between the No Action Alternative and the Preferred 

Alternative.

As discussed in Section 4.3.4, climate change could contribute to changes in insect 

pressure in agricultural systems. To the extent that climate change results in more 

lepidopteran insect pressure, there may be an increased need to manage lepidoteran pests 

with insecticides. If this were to occur, a market for MON 87701 soybeans in the U.S. 

could result in the developer seeking a registration from EPA to allow for commercial use 

of MON 87701. 

5.10 Cumulative Impacts: Animal Communities

Under EPA registration, MON 87701 is restricted to 15,000 acres in seven states and 

Puerto Rico. However, Cry1Ac is also expressed in commercially available cotton 

products either alone or in combination with other insecticidal proteins (Bio, 2011). As 

discussed in Section 4.4.1 MON 87701 is not toxic to vertebrate animals. It expresses a 
56

protein, Cry1Ac that is toxic to certain lepidopteran species. Caterpillars that eat Cry1Ac 

plants die or, at lower exposures, have delayed development. Other orders of insects are 

not affected by the Cry1Ac endotoxin and would not be affected by MON 87701. 

Because of the limited amount of MON 87701 allowed on the landscape, it would not 

contribute to the total number of crop acres that express the Cry1Ac protein. There are 

about 10.5 million acres of cotton planted in the U.S., with approximately 1.9 million of 

those acres located in states were MON 87701 is registered for use for seed increase by 

EPA.

The petitioner has indicated that in the future, MON 87701 could be made available to 

commercial soybean growers in the U.S. Before this could occur, the developer would 

need to request an EPA registration for this use. The predicted adoption areas, based on 

current insect pressures, could be as many as 9 million acres of soybeans. In the states 

that also grow cotton, the number of soybean acres is about 2 million. It is unlikely that 

all of these acres would adopt MON 87701 because insecticides are not currently used on 

all soybean acres in this area, because not all soybean acres are subject to lepidopteran 

pressure. Those growers that consistently use insecticides to control lepidopteran pests in 

soybeans are the most likely adopters. In these same areas, about 5.4 million acres of 

cotton are grown. Therefore, in cotton growing areas, MON 87701 soybeans could 

increase the acreage of Cry1Ac by about 35 percent. This could increase the exposure of 

animals to Cry1Ac in the environment. Vertebrate animals are not affected by Cry1Ac 

(see discussion in Section 4.4.1), so the change in exposure will not impact these animals. 

Insect populations that feed on both cotton and soy could experience greater exposure. 

As a result, there could be a reduction in these populations in areas where both cotton and 

soybeans are grown (Hutchison et al., 2010). It is important to recognize that these 

insects are the intended target for the insecticidal properties in these crops.

Non-target invertebrates could also experience greater exposure to the Cry1Ac endotoxin. 

As described in Section 4.4.1, non-target invertebrate populations are not likely to be 

effected by the Cry1Ac endotoxin, so the increase in exposure would not change the 

effects on these populations compared to the current situation. 

In cotton, a decrease in insecticide use as a result of the use of Bt cottons has been seen. 

The same reductions may not occur with the adoption of Bt soybeans because the 

majority of soybeans are not treated with insecticides and many of the pests of soybeans 

are not susceptible to Cry1Ac. So, while in cotton there may be an observed benefit to 

beneficial insects, in soybeans there is not likely to be the same benefit. 

Target Insect Resistance

Insect resistance management is often required as part of the EPA registration for Bt 

crops. Because of the limited acreage allowed for MON 87701, specific refuge 

requirements are not part of its EPA registration. However, the EPA permit for MON 

87701 has a monitoring requirement, a remedial action plan, and required sales reporting. 

If the cultivation range was to expand in the future, a new EPA registration application 

may require specific refuge requirements (US-EPA, 2010a). Some insects that are 

controlled by MON 87701 are also pest insects of cotton. The current natural refuge for 
57

cotton in the areas where MON 87701 would most likely be adopted include soybean 

acreage as part of the natural refuge (US-EPA, 2010a). The adoption of MON 87701 in 

these areas with high rates of lepidopteran pests could increase the overall acreage of 

plants expressing this protein. Insects, like soybean loopers can attack both cotton and 

soybean so there is a potential for greater exposure of that population to this protein in 

these areas. This could contribute to driving resistance in these populations. However, 

since numerous plant species have been reported as hosts for this pest (Harding 1976), 

these plants may act as a breeding area (i.e., refuge) where this pest can reproduce 

without pressure of Bt-expressing plants and/or Bt-based insecticide sprays.

Any future action to change the area where MON 87701 is EPA registered to be grown 

would take into account the other Bt crops in the area as well as any natural refuge in 

designing resistance management plan.

5.11 Cumulative Impacts: Plant Communities 

APHIS has not identified any different effect from the cultivation of MON 87701 

soybeans than from other available soybean varieties. MON 87701 is similar in all 

respects to other soybeans except for the expression of Cry1Ac. This Cry protein is toxic 

to certain lepidopteran insects; it does not have any effect on plants. Therefore, APHIS 

has not identified any cumulative impacts on plants from the cultivation of MON 87701 

soybeans.

5.12 Cumulative Impacts: Gene Flow and Weediness

The soybean industry has identity protection measures in place to restrict pollen 

movement and gene flow between soybean fields through the use of isolation distances, 

border and barrier rows, the staggering of planting dates and various seed handling and 

transportation procedures (Bradford, 2006; NCAT, 2003; Sundstrom et al., 2002). MON 

87701 soybean that is cultivated for seed will be grown using these practices. In 

addition, there is no evidence that horizontal gene transfer and expression of DNA occurs 

between soybean and soil bacteria or unrelated plant species under natural field 

conditions, and even if this did occur, proteins corresponding to the transgenes are not 

likely to be produced. Gene movement between sexually compatible soybean varieties is 

no greater for MON 87701 soybean than it is for other non-GE or GE cultivars. Based on 

the scientific evidence, APHIS has not identified any cumulative effects on gene 

movement that would occur from a determination of nonregulated status to MON 87701 

soybeans.

5.13 Cumulative Impacts: Microorganisms

Bt from root exudates do occur in soils where GE Bt crops are planted. As discussed in 

Section 4.3.2, these exudates do not affect soil quality. Therefore, the production of 

MON 87701, even in rotation with other Bt crops, will not cumulatively impact soil 

quality or microorganisms when compared to the No Action Alternative.
58

5.14 Cumulative Impacts: Biodiversity 

APHIS has determined that there are no impacts from past, present, or reasonably 

foreseeable actions that would aggregate with effects of the proposed action to create 

cumulative impacts or reduce the long-term productivity or sustainability of any of the 

resources associated with the ecosystem in which MON 87701 is planted. 

MON 87701 is similar in all respects to other soybeans except for the expression of 

Cry1Ac. This Cry protein is toxic to certain lepidopteran insects. APHIS has evaluated 

the effects of these soybeans on nontarget organisms and determined that there is no 

effect (see section 4.4.5) on nontarget organisms. MON 87701 could be grown in areas 

where other GE crops expressing Bt proteins are grown and add to total interaction of GE 

Bt expressing plants and the environment. Under the current EPA registration this 

addition is minimal. However, in the future, if the registration is changed, larger acreage 

of MON 87701 could be cultivated. It is unlikely that this incremental increase in Bt 

crops will have a cumulative effect on biodiversity because the GE Bt expressing crops 

have been cultivated 1996 without adverse impacts on biodiversity in the areas of 

cultivation.

5.15 Cumulative Impacts: Human Health

MON 87701 soybeans express a protein, Cry1Ac, which is toxic to certain lepidopteran 

species. This protein is not toxic to vertebrate animals, including humans, and has no 

similarities to known allergens (see discussion in Section 4.5). This protein has an 

exemption from tolerance from the EPA. There are no effects on human health from the 

consumption of this protein. The Monsanto Company initiated the consultation process 

with FDA for the commercial distribution of MON 87701 and submitted a safety and 

nutritional assessment of food and feed derived from MON 87701 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, 2010a). Based on the 

information the Monsanto Company submitted, and as of August 5, 2010, FDA has no 

further questions regarding MON 87701 soybean. Therefore, a determination of 

nonregulated status of MON 87701 will not result in any cumulative effects to human 

health of consumers.

MON 87701 soybeans could result in lower use of insecticides on fields that may be 

treated for lepidoteran insect damage. This could reduce exposure of workers to 

insecticides if the number of applications of insecticide were reduced due to the adoption 

of this product. Under the current EPA registration, the limited number of acres of MON 

87701 soybeans would reduce the likelihood that there would be any measurable 

reduction in pesticide use in any area. Individual workers may be exposed to fewer 

insecticide applications, but, as a group, worker exposure would not change.

If MON 87701 were EPA registered in the future for use in the U.S. on a greater number 

of acres there is a possibility that regional adoption of MON 87701 could reduce worker 

exposure to insecticides used on soybeans in certain areas. However, this reduction 

would only occur in areas where lepidopteran pressure is high and other insects are not of 
59

economic importance. Expression of the same Bt protein in cotton resulted in a reduction 

in insecticide use on cotton. However, this may not occur in soybeans because most 

soybean acres are not treated for insects. As discussed above in Section 4.7.3, southern 

states would be most likely to adopt this technology if it were available. Soybean acreage 

in these states accounts for about 15 percent of the total soybean acreage in the U.S. 

Adoption is likely to vary by location even in these southern states. The overall change 

in pesticide use may be measurable locally, but is unlikely to change significantly with 

respect to overall insecticide use on soybeans. Therefore, the potential for some 

reduction in insecticide use on soybean fields as the result of a possible future change in 

EPA registration of MON 87701 is not likely to result in cumulative impacts to worker 

health when compared to current soybean agricultural practices. 

5.16 Cumulative Impacts: Animal Feed

A determination of nonregulated status of MON 87701 will not change the current EPA 

restrictions on cultivation of MON 87701 for seed increase, only. Under the current EPA 

permit restrictions, there would be no cumulative impacts to animal feed and livestock 

health associated with MON 87701 soybean seed.

The petitioner has indicated that in the future MON 87701 could be made available to 

commercial soybean growers in the U.S. Before this could occur, the developer would 

need to request an EPA registration for this use.

As with human health, the Cry1Ac protein expressed in MON 87701 soybeans, which is 

toxic to certain lepidopteran species, is not toxic to vertebrate animals, including 

livestock, and has no similarities to known allergens (see discussion in Section 4.5). This 

protein has an exemption from tolerance from the EPA. There are no anticipated effects 

on livestock health from the consumption of this protein.

The FDA has completed its consultation on MON 87701 (FDA, 2010b). Based on a 

review of composition and nutritional characteristics of MON 87701 soybean, the FDA 

has concluded that MON 87701 soybean is not materially different in any respect 

relevant to feed safety compared to soybean varieties already on the market (FDA, 

2010a). If a determination of nonregulated status of MON 87705 soybean is made and 

commercial cultivation of MON 87701 is permitted by EPA in the future, no cumulative 

effects would be anticipated. 

5.17 Cumulative Impacts: Domestic Economic Environment

Under both the No Action and Preferred Alternatives, cultivation of MON 87701 would 

be restricted to the seven states and Puerto Rico as specified in the current EPA 

registration, limiting the overall number of acres to 15,000. Also, planting of MON 

87701 would remain limited to breeding and seeds increase activities and will not be 

available for domestic use. A determination of nonregulated status of MON 87701 will 

not change the distribution or limits on the acreage of these soybeans because the current 

EPA registration sets those restrictions. Under these current permit conditions, there 
60

would be no cumulative impacts to the domestic soybean market associated with MON 

87701 soybean seed.

The petitioner has indicated that in the future a registration that allows for planting this 

soybean domestically may be sought from EPA. As previously discussed, these soybeans 

would only likely be adopted in soybean production areas of southern states with high 

lepidopteran pest pressure (i.e., Alabama, Arkansas, Florida, Georgia, Kentucky, 

Louisiana, Mississippi, Missouri, North Carolina, South Carolina, Tennessee, Texas, 

and Virginia (Leonard, 2011). In 2010, in these states, GE soybeans with GE herbicidetolerant traits (the only GE traits available in soybeans) account for approximately 90 to 

98 percent of all soybeans planted in those states. If approved for commercial 

production, the market penetration would be determined by the price of soybeans, the 

cost of the product, and the cost effectiveness of other pesticides for controlling insect 

pests. Since soybean acreage in these states accounts for about 15 percent of the total 

soybean acreage in the U.S., the total market penetration is unlikely to exceed 15 percent

of the domestic soybean market. 

 

5.18 Cumulative Impacts: Trade Economic Environment

MON 87701 was engineered to control lepidoptran pests of soybeans. These pests are 

more economically important in tropical and semi-tropical areas of the world than in 

temperate climates. MON 87701 soybean is EPA-registered for seed increase in the U.S. 

so that it can be exported for planting in other markets. MON 87701 will likely be 

conventionally crossed with nonregulated GE herbicide resistant soybean varieties to 

create new varieties to target both lepidopteran and weed pressure. 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). 

Soybean seed exports for crop cultivation are a minor part of the current soybean export 

market. Table 5 illustrates the worldwide trends for soybean exports over the next ten 

years. Trends for increasing overseas markets coupled with greater production and 

export from the target markets for this seed could increase the market for soybean seed 

exported for planting from the southern U.S. states. The contribution to the overall 

soybean export market will be insignificant because most soybean seed is exported for 

processing not planting. The increase in seed exports that may result from a 

determination of nonregulated status of MON 87701 is small compared to the total export 

market. Therefore, for the Preferred Alternative, there are no expected cumulative 

impacts on soybean exports.

In the future, if the EPA registration is changed to allow commercial production of MON 

87701 in the U.S., a larger acreage of MON 87701 could be cultivated. MON 87701 

would likely be stacked with other nonregulated soybean varieties, particularly GE 

herbicide resistant soybean varieties, to create new varieties to target both lepidopteran 

and weed pressure. However, as stated previously, adoption of a soybean variety 

containing MON 87701 is most likely to occur only in the southern U.S. where 

lepidopteran insect pressure can reach economic levels. The states that might adopt MON 
61

87701 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 

of the total soybean acres of the U.S. It is unlikely that all of these acres would be 

converted to MON 87701 soybeans, because insect pressure is not uniform in all areas of 

a state. Therefore, it is likely that if MON 87701 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. Additionally, since MON 87701 is expected to be crossed with already 

available GE soybean, it is unlikely that any additional soybean acreage would be 

cultivated in these areas as a result of the availability of MON 87701 on a commercial 

scale. Given this small percentage of potential total soybean acres planted with MON 

87701 and the prediction of a declining share of worldwide soybean exports for the U.S.

(Table 5), any contribution of MON 87701-containing soybean varieties to future trade 

exports would be insignificant. No cumulative impacts on the trade economic 

environment are anticipated.
62

Table 5. Soybean trade long-term projections.

2009/10 2010/11 2011/12 2012/13 2013/14 2014/15 2015/16 2016/17 2017/18 2018/19 2019/20 2020/21

Importers Imports, million metric tons

 European Union1 12.9 13.5 13.5 13.1 12.9 12.7 12.5 12.3 12.1 11.9 11.7 11.5

 Japan 3.4 3.5 3.6 3.4 3.3 3.3 3.3 3.2 3.2 3.1 3.1 3.0

 South Korea 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.3 1.3 1.3 1.3 1.3

 Taiwan 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5

 Mexico 3.5 3.6 3.7 3.8 3.9 4.0 4.1 4.1 4.2 4.3 4.4 4.5

 Former Soviet 

Union2 1.0 1.2 1.2 1.3 1.4 1.4 1.5 1.5 1.6 1.6 1.6 1.7

 Other Europe 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5

 China 50.3 57.0 60.7 64.0 66.9 70.1 73.2 76.4 79.4 82.4 85.4 88.3

 Malaysia 0.6 0.6 0.6 0.6 0.6 0.6 0.7 0.7 0.7 0.7 0.7 0.7

 Indonesia 1.6 1.6 1.7 1.7 1.7 1.8 1.8 1.9 1.9 2.0 2.0 2.0

 Other 15.2 11.9 12.1 12.4 12.8 13.1 13.5 13.9 14.2 14.6 15.0 15.3

 Total imports 92.7 97.2 101.4 104.5 107.8 111.3 114.7 118.3 121.6 124.9 128.3 131.5

Exporters Exports, million metric tons

 Argentina 13.0 13.0 13.7 14.8 15.1 15.6 16.1 16.7 17.1 17.5 17.5 17.9

 Brazil 28.6 31.4 33.6 34.5 36.2 37.9 40.0 41.9 43.9 45.9 48.0 49.5

 Other South 

America 7.3 6.4 7.2 7.4 7.8 8.0 8.5 8.9 9.4 9.9 10.5 11.1

 China 0.2 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5

 Other foreign 2.8 3.2 3.6 3.6 3.7 3.8 3.9 3.9 4.1 4.2 4.3 4.4

 United States 40.9 42.7 42.9 43.7 44.5 45.4 45.9 46.4 46.7 47.1 47.5 48.0

 Total exports 92.7 97.2 101.4 104.5 107.8 111.3 114.7 118.3 121.6 124.9 128.3 131.5

Percent

 U.S. trade share 44.1 44.0 42.3 41.8 41.3 40.8 40.0 39.2 38.4 37.7 37.0 36.5

1 Covers EU-27, excludes intra-EU trade. 2 Covers FSU-12. Includes intra-FSU trade.

Source: (USDA-ERS, 2011). Projections completed in November 2010.
63

6 THREATENED AND ENDANGERED SPECIES

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching 

wildlife conservation laws ever enacted by any nation. Congress, on behalf of the 

American people, passed the ESA to prevent extinctions facing many species of fish, 

wildlife, and plants. The purpose of the ESA is to conserve endangered and threatened 

species and the ecosystems on which they depend as key components of America’s 

heritage. To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works in 

cooperation with the National Marine Fisheries Service (NMFS), other Federal, State, 

and local agencies, Tribes, non-governmental organizations, and private citizens. Before 

a plant or animal species can receive the protection provided by the ESA, it must first be 

added to the Federal list of threatened and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be 

endangered or threatened because of any of the following factors:

• The present or threatened destruction, modification, or curtailment of its 

habitat or range;

• Overutilization for commercial, recreational, scientific, or educational 

purposes;

• Disease or predation;

• The inadequacy of existing regulatory mechanisms; and

• The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, in accordance with the ESA, protective 

measures apply to the species and its habitat. These measures include protection from 

adverse effects of Federal activities. 

Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS 

and/or the NMFS, ensure that any action they authorize, fund, or carry out is not likely to 

jeopardize the continued existence of a listed species or result in the destruction or 

adverse modification of designated critical habitat. It is the responsibility of the Federal 

agency taking the action to assess the effects of their action and to consult with the 

USFWS and NMFS if it is determined that the action “may affect” listed species or 

critical habitat. To facilitate APHIS’ ESA consultation process, APHIS met with the 

USFWS to discuss factors relevant to their effects analysis for petitions for 

nonregulated status and developed a process for conducting an effects determination 

(Appendix A). This process is used by APHIS to assist the program in fulfilling their 

obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory 

actions. 

As part the environmental review process, APHIS thoroughly reviews GE product 

information and data to inform the ESA effects analysis and, if necessary, the biological 

assessment. For each transgene(s)/transgenic plant the following information, data, and 

questions are considered by APHIS: 
64

• A review of the biology, taxonomy, and weediness potential of the crop plant 

and its sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function 

and the nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are 

produced in the plant and their quantity;

• A review of the agronomic performance of the plant including disease and 

pest susceptibilities, weediness potential, and agronomic and environmental 

impact;

• Determination of the concentrations of known plant toxicants (if any are 

known in the plant); and

• Analysis to determine if the transgenic plant is sexually compatible with any 

threatened or endangered plant species (TES) or a host of any TES.

There are no known wild Glycine species related to cultivated soybean present in North 

America. Additionally, soybean is a highly self-pollinated species, with cross pollination 

to other soybean varieties occurring at very low frequencies (0.04 to 3.62 percent) in 

adjacent plants (Caviness, 1966). The probability of gene flow and introgression of MON 

87701 into other species in the U.S. is essentially zero (Stewart et al., 2003). Therefore, it 

is unlikely that any outcrossing of MON 87701 with sexually compatible species, 

including threatened or endangered plant species, could occur in the U.S. No effect to 

any threatened or endangered plant species is expected from outcrossing.

APHIS’ evaluation focused on the likelihood of whether TES species would be exposed 

to the toxin expressed in MON 87701 soybean. Exposure of TES species to Cry1Ac is 

only likely if the species occur in the areas where soybean is grown, because soybean 

plant parts (seeds, pollen, crop debris) are not readily transported long distances without 

human intervention. 

The only listed TES animal found in habitat likely to include soybean fields in the area 

where MON 87701 may be cultivated and that might feed on soybean is the Federally 

Endangered Delmarva Peninsula Fox Squirrel, found in areas of the mid-Atlantic Eastern 

seaboard (Sciurus niger cinereus) (http://ecos.fws.gov/tess_public/SpeciesReport.do). 

The squirrel forages for food in woodlots and openings, such as farm fields, with a diet 

that mainly includes acorns, nuts/seeds of hickory, beech, walnut, and loblolly pine. 

They also feed on tree buds and flowers, fungi, insects, fruit, and seeds in the spring and 

mature, green pine cones in the summer and early fall (USF&WS, 1999). Considering 

these factors along with the lack of noted adverse effects on mice and other non-target 

organisms, it is expected that MON 87701 soybean will not have an adverse effect on the 

Delmarva Peninsula Fox Squirrel.
65

The use of transgenic cotton producing the Cry1Ac, the same protein expressed by MON 

87701, has been shown to reduce the use broad spectrum insecticides without significant 

impacts on diversity of non-target insects (Cattaneo et al., 2006; Dively, 2005; Marvier, 

2007; Naranjo, 2005; Naranjo, 2005b. ; Romeis et al., 2006; Torres and Ruberson, 2006; 

Torres and Ruberson, 2005; Whitehouse et al., 2005). Bt toxins expressed in transgenic 

plants for pest management are generally regarded as safe due to their mode of action, 

specificity, and fast degradation in the environment (Glare and O'Callaghan, 2000; 

Romeis et al., 2008; Sanvido et al., 2007; US-EPA, 2008b). Cry1Ab and Cry2Ae 

proteins are highly specific to Lepidoptera. The specificity of Bt crystalline proteins to 

lepidopteran insect larvae, but not for other insects, birds, and mammals results from the 

highly specific receptors for these proteins in the larvae midgut (Arora et al., 2007). 

Once activated by insect-specific proteases in the insect midgut, Cry proteins bind to 

receptors in the midgut. Such binding leads to the formation of pores in the midgut 

membranes and ultimately to cell lysis and death. The specific binding of Bt-based Cry 

proteins to midgut membrane receptors is a key determinant of pest specificity

(Showalter et al., 2009). Accordingly, the APHIS review of the potential impacts is 

focused on Federally listed threatened and endangered lepidopterans in the soybean 

growing regions of the U.S. where MON 87701 potentially could be grown.

APHIS has thoroughly examined all listed and proposed threatened and endangered 

Lepidoptera and compared their habitats to counties and municipios where soybeans of 

this petition could be grown. APHIS has determined that the breeding habitats of listed 

Lepidoptera do not overlap soybean growing areas. Therefore, it is highly unlikely that 

these species can be exposed to Bt soybeans. Threatened and endangered Lepidoptera in 

the U.S. have very restrictive habitat ranges; and their larvae typically feed on specific 

host plants, none of which includes soybeans, or plants likely to be found in soybeans 

fields. There are lepidoptera species that are Federally listed TES in the U.S. (FWS, 

2010). The Mitchell’s satyr butterfly (Neonympha mitchellii mitchelli) occurs in Virginia 

and the St. Francis’s Satyr butterfly (Neonympha mitchellii fransisci) in North Carolina. 

Both species are classified as ‘endangered’ by the U.S. Fish & Wildlife Service (FWS, 

2010). The Dakota skipper (Hesperia dacotae) and the Karner blue butterfly (Lycaeides 

melissa samuelis) are also listed as threatened, endangered, proposed, or candidate 

species (FWS, 2010), but they do not occur in the Coastal Atlantic states, as defined in 

this petition. The habitat of the endangered Saint Francis’ satyr butterfly “consists 

primarily of “wide, wet meadows dominated by a high diversity of sedges and other 

wetland graminoids.” (FWS, 2010) There are no Federally endangered or threatened 

lepidopteran species present in Georgia, Maryland, Arkansas, Illinois, South Carolina, or 

Puerto Rico (FWS, 2010). These three species are not known to feed on soybeans (The 

Xerces Society for Invertebrate Conservation).

Based on the above information, APHIS has determined that the Preferred Alternative, a 

determination of nonregulated status of MON 87701 soybeans, would have no effect on 

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

habitat proposed for designation. Consequently, a written concurrence or formal 

consultation with the US FWS is not required for this action
66

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND 

TREATIES RELATING TO ENVIRONMENTAL IMPACTS

7.1.1 Executive Orders with Domestic Implications

The following executive orders require consideration of the potential impacts of the 

Federal action to various segments of the population.

• Executive Order (EO) 12898 (US-NARA, 2010), "Federal Actions to 

Address Environmental Justice in Minority Populations and Low-Income 

Populations," requires Federal agencies to conduct their programs, policies, 

and activities that substantially affect human health or the environment in a 

manner so as not to exclude persons and populations from participation in or 

benefiting from such programs. It also enforces existing statutes to prevent 

minority and low-income communities from being subjected to 

disproportionately high and adverse human health or environmental effects. 

• EO 13045, “Protection of Children from Environmental Health Risks and 

Safety Risks,” acknowledges that children may suffer disproportionately from 

environmental health and safety risks because of their developmental stage, 

greater metabolic activity levels, and behavior patterns, as compared to adults. 

The EO (to the extent permitted by law and consistent with the agency’s 

mission) requires each Federal agency to identify, assess, and address 

environmental health risks and safety risks that may disproportionately affect 

children.

Each alternative was analyzed with respect to EO 12898 and 13045. Neither alternative 

is expected to have a disproportionate adverse effect on minorities, low-income 

populations, or children. As presented in the Environmental Consequences section, no 

significant impacts were identified in the analyses conducted on human health or the 

physical environment. 

MON 87701 has been shown to be no difference in compositional and nutritional quality 

compared to conventional soybean, apart from the presence of the Cry1Ac protein. The 

inserted gene (cry1Ac) and protein (Cry1Ac) expressed in MON 87701 are not expected 

to be allergenic, toxic, or pathogenic in mammals. The Cry1Ac protein has a history of 

safe consumption in the context of other food and feeds (FDA, 2010c). This information 

establishes the safety of MON 87701 and its products to humans, including minorities 

and low income populations who might be exposed to them through agricultural 

production and/or processing. No additional safety precautions would need to be taken. 

None of the impacts on agricultural practices expected to be associated with a 

determination of nonregulated status of MON 87701 are expected to have a 

disproportionate adverse effect on minorities and low income populations. MON 87701 

is genetically engineered to express an insecticidal protein, Cry1Ac. MON 87701 may 

potentially be stacked with currently available nonregulated herbicide tolerant traits. 

Thus, pesticide application practices and usage associated with a determination of 
67

nonregulated status of MON 87701 are not expected to change from the current trends for 

existing nonregulated GE soybeans.

MON 87701 has been shown to be no difference in compositional and nutritional quality 

compared to conventional soybean, apart from the presence of the Cry1Ac protein. The 

inserted gene (cry1Ac) and protein (Cry1Ac) expressed in MON 87701 are not expected 

to be allergenic, toxic, or pathogenic in mammals. The Cry1Ac protein has a history of 

safe consumption in the context of other food and feeds (FDA, 2010c). This information 

establishes the safety of MON 87701 and its products to humans, including children who 

might be exposed to them through agricultural production and/or processing. No 

additional safety precautions would need to be taken. 

None of the impacts on agricultural practices expected to be associated with a 

determination of nonregulated status of MON 87701 are expected to have a 

disproportionate adverse effect on children. MON 87701 is genetically engineered to 

express an insecticidal protein, Cry1Ac. MON 87701 may potentially be stacked with 

currently available nonregulated herbicide tolerant traits. Thus, pesticide application 

practices and usage associated with a determination of nonregulated status of MON 

87701 are not expected to change from the current trends for existing nonregulated GE 

soybeans.

The following executive order addresses Federal responsibilities regarding the 

introduction and effects of invasive species:

EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal 

agencies take action to prevent the introduction of invasive species, to 

provide for their control, and to minimize the economic, ecological, and 

human health impacts that invasive species cause. 

All soybean varieties, including MON 87701, require human assistance to persist beyond 

a first generation of soybean plants that may arise from spilled seed; they do not establish 

self-propagating populations. Soybean does not possess traits that are characteristic of 

invasive species (Baker and Academic Press, 1965.).

The following executive order requires the protection of migratory bird populations:

EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agencies to 

Protect Migratory Birds,” states that federal agencies taking actions that 

have, or are likely to have, a measurable negative effect on migratory bird 

populations are directed to develop and implement, within two years, a 

Memorandum of Understanding (MOU) with the Fish and Wildlife 

Service that shall promote the conservation of migratory bird populations. 

MON 87701 has been shown to be no difference in compositional and nutritional quality 

compared to conventional soybean, apart from the presence of the Cry1Ac protein. The 

inserted gene (cry1Ac) and protein (Cry1Ac) expressed in MON 87701 are not expected 

to be allergenic, toxic, or pathogenic in mammals. The Cry1Ac protein has a history of 

safe consumption in the context of other food and feeds (FDA, 2010c). Based on APHIS’ 
68

assessment of MON 87701, it is unlikely that a determination of nonregulated status of 

MON 87701 will have a negative effect on migratory bird populations.

7.1.2 International Implications

EO 12114 (US-NARA, 2010), “Environmental Effects Abroad of Major Federal 

Actions” requires federal officials to take into consideration any potential environmental 

effects outside the U.S., its territories, and possessions that result from actions being 

taken. 

APHIS has given this EO careful consideration and does not expect a significant 

environmental impact outside the U.S. in the event of a determination of nonregulated 

status of MON 87701. All existing national and international regulatory authorities and 

phytosanitary regimes that currently apply to introductions of new soybean cultivars 

internationally apply equally to those covered by an APHIS determination of 

nonregulated status under 7 CFR part 340. 

Any international trade of MON 87701 subsequent to a determination of nonregulated 

status of the product would be fully subject to national phytosanitary requirements and be 

in accordance with phytosanitary standards developed under the International Plant 

Protection Convention (IPPC, 2010). The purpose of the IPPC “is to secure a common 

and effective action to prevent the spread and introduction of pests of plants and plant 

products and to promote appropriate measures for their control” (IPPC, 2010). The 

protection it affords extends to natural flora and plant products and includes both direct 

and indirect damage by pests, including weeds. 

The IPPC establishes a standard for the reciprocal acceptance of phytosanitary 

certification among the nations that have signed or acceded to the Convention (172 

countries as of March 2010). In April 2004, a standard for PRA of living modified 

organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a 

supplement to an existing standard, International Standard for Phytosanitary Measure No. 

11 (ISPM-11, Pest Risk Analysis for Quarantine Pests). The standard acknowledges that 

all LMOs will not present a pest risk and that a determination needs to be made early in 

the PRA for importation as to whether the LMO poses a potential pest risk resulting from 

the genetic modification. APHIS pest risk assessment procedures for genetically 

engineered organisms are consistent with the guidance developed under the IPPC. In 

addition, issues that may relate to commercialization and transboundary movement of 

particular agricultural commodities produced through biotechnology are being addressed 

in other international forums and through national regulations.

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on 

Biological Diversity (CBD) that established a framework for the safe transboundary 

movement, with respect to the environment and biodiversity, of LMOs, which include 

those modified through biotechnology. The Protocol came into force on September 11, 

2003, and 160 countries are Parties to it as of December 2010 (CBD, 2010). Although 

the U.S. is not a party to the CBD, and thus not a party to the Cartagena Protocol on 

Biosafety, U.S. exporters will still need to comply with those regulations that importing 
69

countries which are Parties to the Protocol have promulgated to comply with their 

obligations. The first intentional transboundary movement of LMOs intended for 

environmental release (field trials or commercial planting) will require consent from the 

importing country under an advanced informed agreement (AIA) provision, which 

includes a requirement for a risk assessment consistent with Annex III of the Protocol and 

the required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, 

and are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties 

must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs 

for FFP that may be subject to transboundary movement. To facilitate compliance with 

obligations to this protocol, the U.S. Government has developed a website that provides 

the status of all regulatory reviews completed for different uses of bioengineered products

(NBII, 2010). These data will be available to the Biosafety Clearinghouse. 

APHIS continues to work toward harmonization of biosafety and biotechnology 

consensus documents, guidelines, and regulations, including within the North American 

Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S., 

and within the Organization for Economic Cooperation and Development (OECD). 

NAPPO has completed three modules of the Regional Standards for Phytosanitary 

Measures (RSPM) No. 14, Importation and Release into the Environment of Transgenic 

Plants in NAPPO Member Countries (NAPPO, 2009).

APHIS also participates in the North American Biotechnology Initiative (NABI), a forum 

for information exchange and cooperation on agricultural biotechnology issues for the 

U.S., Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory 

issues are held regularly with other countries including Argentina, Brazil, Japan, China, 

and Korea.

7.1.3 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the changes in soybean production due to the unrestricted use of MON 

87701. Cultivation of MON 87701 is not expected to lead to the increased production of 

soybean in U.S. agriculture. 

There is no expected change in water use and quality due to the cultivation of MON 

87701 compared with current soybean production. Also, there is no expected change in 

air quality associated with the cultivation of MON 87701.

Based on this review, APHIS concludes that the cultivation of MON 87701 would 

comply with the Clean Water Act and the Clean Air Act.

7.1.4 Impacts on Unique Characteristics of Geographic Areas

A determination of nonregulated status of MON 87701 is not expected to impact unique 

characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild 

and scenic areas, or ecologically critical areas. 
70

The common agricultural practices that would be carried out in the cultivation of MON 

87701 are not expected to deviate from current practices. The product is expected to be 

deployed on agricultural land currently suitable for production of soybean and replace 

existing varieties, and is not expected to increase the acreage of soybean production. 

There are no proposed major ground disturbances; no new physical destruction or 

damage to property; no alterations of property, wildlife habitat, or landscapes; and no 

prescribed sale, lease, or transfer of ownership of any property. This action is limited to a 

determination of nonregulated status of MON 87701. 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,

including the use of EPA registered pesticides. 

7.1.5 National Historic Preservation Act (NHPA) of 1966 as Amended 

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal 

agencies to: 1) determine whether activities they propose constitute "undertakings" that 

have the potential to cause effects on historic properties and 2) if so, to evaluate the 

effects of such undertakings on such historic resources and consult with the Advisory 

Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic 

Preservation Officers), as appropriate. 

APHIS’ proposed action, a determination of nonregulated status of MON 87701 is not 

expected to adversely impact cultural resources on tribal properties. Any farming activity 

that may be taken by farmers on tribal lands would only be conducted at the tribe’s 

request; thus, the tribes would have control over any potential conflict with cultural 

resources on tribal properties.

APHIS’ Preferred Alternative would have no impact on districts, sites, highways, 

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

Places, nor would it likely cause any loss or destruction of significant scientific, cultural, 

or historical resources. 

APHIS’ proposed action is not an undertaking that may directly or indirectly cause 

alteration in the character or use of historic properties protected under the NHPA. In 

general, common agricultural activities conducted under this action do not have the 

potential to introduce visual, atmospheric, or noise 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 increased noise on the use and enjoyment of a historic 

property during the operation of tractors and other mechanical equipment close to such 

sites. Nevertheless, it is expected that this noise would only be temporary and short-term. 

The cultivation of MON 87701 is not expected to change any of these agronomic 

practices that would result in an adverse impact under the NHPA.
71

8 REFERENCES

.

Adam, K. (2005). Seed production and variety development for organic systems. 

National Sustainable Agriculture Information Service. Retrieved from 

Al-Deeb, M. A., Wilde, G. E., Blair, J. M., and Todd, T. C. (2003) Effect of Bt Corn for 

Corn Rootworm Control on Nontarget Soil Microarthropods and Nematodes. 

Environmental Entomology, 32(4), 859-865.

Altieri, M. (1999) The ecological role of biodiversity in agroecosystems. Agriculture, 

Ecosystems and Environment, 74, 19-31.

Aneja, V., Schlesinger, W., and Erisman, J. (2009) Effects of agriculture upon the air 

quality and climate: Research, policy, and regulations. Environmental Science and 

Technology, 43(12), 4234-4240.

AOSCA Moline, I. (2009) Seed Certification Handbook. Association of Official Seed 

Certifying Agencies.

Aref, S.and Pike, D. R. (1998) Midwest farmers' perceptions of crop pest infestation. 

Agronomy Journal, 90(6), 819-825.

Arora, N., Agrawal, N., Yerramilli, V., and Bhatnagar, R. (2007). Biology And 

Applications Of Bacillus Thuringiensis In Integrated Pest anagement. In A. 

Ciancio & K. G. Mukerji (Eds.), General Concepts in Integrated Pest and 

Disease Management (pp. 227-244): Springer Netherlands.

ASA. (2010). Soystats 2010. Retrieved April 15, 2011, from American Soybean 

Association http://www.soystats.com/2010/Default-frames.htm

ASA. (2011). Soy Stats: A Reference Guide to Important Soybean Facts and Figures. 

Retrieved April 19, from American Soybean 

Association http://www.soystats.com/2011/

Baker, H. G. P.and Academic Press, N. Y. (1965.) Characteristics and modes of origin of 

weeds in The

Genetics of Colonizing Species. Baker, H.G. and G.L. Stebbins (eds.) Academic Press, 

New York, 147-172.

Baker, J., Southard, R., and Mitchell, J. (2005) Agricultural dust production in standard 

and conservation tillage systems in the San Joaquin Valley. Journal of 

Environmental Quality, 34(4), 1260-1269.

Bale, J., Masters, G., Hodkinson, I., Awmack, Bezemer, T., Brown, V., Butterfield, J., 

Buse, A., Coulson, J., Farrar, J., Good, J., Harrington, R., Hartley, S., Jones, T. 

H., Lindroth, R., Press, M., Symrnioudis, I., Watt, A., and Whittaker, J. (2002) 

Herbivory in global climate change research: direct effects of rising temperature 

on insect herbivores. Global Change Biology, 8(1), 1-16.

Baumgarte, S.and Tebbe, C. (2005) Field studies on the environmental fate of the 

Cry1Ab Bt-toxin produced by transgenic maize (MON810) and its effect on 

bacterial communities in the maize rhizosphere. Molecular Ecology, 14(8), 2539-

2551.

BCH (2010). Country's Decision or any other Communication Biosafety Clearing House. 

Retrieved April, 2011 from http://bch.cbd.int/database/recordv4.shtml?documentid=101478

Beuerlein, J. (2005) 2005 Ohio Soybean Inoculation Report (Report: Ohio State 

University. Retrieved 
72

from http://agcrops.osu.edu/specialists/soybean/resources/current-researchprojects/2005SoyInoculationReport.pdf/view

Bio. (2011). Bio Trade Status. Retrieved April, from Biotechnology Industry 

Organizations http://www.biotradestatus.com/results.cfm

Blackwood, C.and Buyer, J. (2004) Soil microbial communities associated with Bt and 

Non-Bt corn in three soils. Journal of Environmental Quality, 33(3), 832-836.

Boerma, H.and Specht, J. (2004). Soybeans: Improvement, Production, and Uses. 

American Society of Agronomy, Crop Science Society of America, Soil Science 

Society of America, Madison, WI.

Bottomley, P. J. (1992). Ecology of Bradyrhizobium and Rhizobium. In G. Stacey, R. H. 

Burris & H. J. Evans (Eds.), Biological Nitrogen Fixation (pp. 293 - 348). New 

York: Routledge, Chapman and Hall.

Bradford, K. (2006) Methods to maintain genetic purity of seed stocks. Agricultural 

Biotechnology in California Series., Publication 8189, 1-4.

Carpenter, J., Felsot, A., Goode, T., Hammig, M., Onstad, D., and Sankula, S. (2002). 

Comparative Environmental Impacts of Biotechnology-derived and Traditional 

Soybean, Corn, and Cotton Crops. Council for Agricultural Science and 

Technology. Retrieved 

from http://www.soyconnection.com/soybean_oil/pdf/EnvironmentalImpactStudy

-English.pdf

CAST. (2009) Sustainability of U.S. soybean production: Conventional, transgenic, and 

organic production systems. (Report: Ames, Iowa: The Council for Agricultural 

Science and Technology Retrieved from http://www.askforce.org/web/CAST/CAST-Soybean-Special-Pub-30-web-optimized.pdf

Cattaneo, M. G., Yafuso, C., Schmidt, C., Huang, C.-y., Rahman, M., Olson, C., EllersKirk, C., Orr, B. J., Marsh, S. E., Antilla, L., Dutilleul, P., and Carrière, Y. (2006)

Farm-scale evaluation of the impacts of transgenic cotton on biodiversity, 

pesticide use, and yield. Proceedings of the National Academy of Sciences, 

103(20), 7571-7576.

Caviness, C. E. (1966) Estimates of natural cross-pollination in Jackson soybeans in

Arkansas. Crop Sci., 6211-212.

CBD (2010). The Cartegena Protocol on Biosafety Convention on Biological Diversity. 

Retrieved April 18, 2011, from http://bch.cbd.int/protocol/

Croft, B. A. (1990). Arthropod Biological Control Agents and Pesticides. John Wiley and 

Sons, New York.

Dale, V. H. (1997) The Relationship Between Land-Use Change and Climate Change. 

Ecological Applications, 7(3), 753-769.

Dalley, C. D., K.A. Renner, and J.J. Kells.. ., . ( 2001) Weed competition in Roundup 

Ready soybeans and corn. Michigan State University, Dept of Crop and Soil 

Science.

Department, S. C. (2001). South Carolina Seed Certification Standards. Department of 

Fertilizer & Seed Certification Services of Clemson University. Retrieved 

from http://www.clemson.edu/public/regulatory/plant_industry/fertilizer_seed/im

ages/SCertStandards.pdf
73

Devare, M. H., Jones, C. M., and Thies, J. E. (2004) Effects of Cry3Bb Transgenic Corn 

and Tefluthrin on the Soil Microbial Community: Biomass, Activity, and 

Diversity. Journal of Environmental Quality(33), 837-843.

Dively, G. P. (2005) Impact of Transgenic VIP3A x Cry1Ab Lepidopteran-resistant Field

Corn on the Nontarget Arthropod Community. Environ. Entomol. . 34, 1267-

1291.

Doran, J., Sarrantonio, M., and Liebig, M. (1996) Soil health and sustainability. Advances 

in Agronomy, 56, 1-54.

Dubelman, S., B.R. Ayden, B.M. Bader, C.R. Brown, C. Jiang, and D. Vlachos. . (2005.) 

Cry1Ab Protein does not persist in soil after 3 years of sustained Bt Corn use.

Environm. Entomol.. 34, 915-921.

Farooq, F. T.and Vessey, J. K. (2009) Genetic diversity of Bradyrhizobium japonicum 

within soybean growing regions of the north-eastern Great Plains of North 

America as determined by REP-PCR and ERIC-PCR profiling. 48(1/3), 131-142.

Faust, M. (2002) New feeds from genetically modified plants: the US approach to safety 

for animals and the food chain. Livestock Production Science, 74(3), 239-254.

FDA (2010a). Biotechnology Consultation Agency Response Letter BNF No. 000119 

(August 18, 2010). U.S. FDA/CFSAN. Retrieved 

from http://www.fda.gov/Food/Biotechnology/Submissions/ucm225022.htm

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

and Drug Administration. Retrieved 

from http://www.fda.gov/Food/Biotechnology/Submissions/ucm225023.htm

FDA (2010c). FDA List of completed consultations on bioengineered foods U.S. Food 

and Drug Administration Retrieved April 15, 2011 

from http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing

&id=1

Fernandez-Cornejo, J.and Caswell, M. (2006).The first decade of genetically engineered 

crops in the United States Washington, D.C. Last accessed 

from http://www.ers.usda.gov/publications/eib11/eib11.pdf

Flachowsky, G., Chesson, A., and Aulrich, K. (2005) Animal nutrition with feeds from 

genetically modified plants. Archives of Animal Nutrition, 59(1), 1 - 40.

FWS. (2011). Endangered species program: Species search. Retrieved April 15 2011, 

from U.S. Fish and Wildlife 

Service http://www.fws.gov/endangered/species/index.html

Garbeva, P., van Veen, J. A., and van Elsas, J. D. (2004) Microbial diversity in soil: 

Selection of microbial populations by plant and soil type and implications for 

disease suppressiveness. Annual Review of Phytopathology, 42(1), 243-270.

GCIA (1988). Soybean Seed Certification Standards. Georgia Crop Improvement 

Association, Inc. Retrieved from http://www.certifiedseed.org/

Glare, T. R.and O'Callaghan, M. (2000). Bacillus thuringiensis: Biology, Ecology and 

Safety. John Wiley and Sons, Ltd, Chichester.

Glaser, J. A.and Matten, S. R. (2003) Sustainability of insect resistance management 

strategies for transgenic Bt corn. Biotechnology Advances, 22(1-2), 45-69.

Gouge, D., Way, M., Knutson, A., Cronholm, G., and Patrick, C. (2011). Managing 

Soybean Insects Texas Agricultural Extension Service. Retrieved April, 2011 

from http://insects.tamu.edu/extension/bulletins/b-1501.html
74

Harlan, J. R. (1975) Our vanishing genetic resources. Science, 188(4188), 618-621.

Hartman, G. L.,4th ed. American Phytopathological Society, St. Paul, MN. (1999). 

Compendium of SoybeanDiseases. 

Heatherly, L., Dorrance, A., Hoeft, R., Onstad, D., Orf, J., Porter, P., Spurlock, S., and 

Young, B. (2009) Sustainability of U.S. Soybean Production: Conventional, 

Transgenic, and Organic Production Systems (Report: Ames, Iowa, USA: Council 

for Agricultural Science and Technology. 

Heatherly, L. G.and Hodges, H., F. (Eds.). (1999). Soybean production in the midsouth. 

Boca Raton, FL: CRC Press.

Herbert, A., Hull, C., and Day, E. (2009). Corn Earworm Biology and Management in 

Soybean Virginia Cooperative Extension, Virginia State University. Retrieved 

April 2011 from http://www.pubs.ext.vt.edu/444/444-770/444-770.html

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

Society of America, 

Hoeft, R. G., Nafziger, E. D., Johnson, R. R., and Aldrich, S. R. (2000). Modern corn and 

soybean production. MCSP Publications, Champaign, IL.

Hofmann, C., H. Vanderbruggen, H. Hoefte, J.V. Rie, S. Jansens, and H.V. Mellaert.. . . 

(1988).Specificity of Bacillus thuringiensis delta-endotoxins is correlated withthe 

presence of high-affinity binding sites in the brush border membrane oftarget 

insect midguts. United States of America. 

Hofmann, C., Lüthy, P., Hütter, R., and Pliska, V. (1988) Binding of the delta endotoxin 

from Bacillus thuringiensis to brush-border membrane vesicles of the cabbage 

butterfly (Pieris brassicae). European Journal of Biochemistry, 173(1), 85-91.

Höss, S., Arndt, M., Baumgarte, S., Tebbe, C. C., Nguyen, H. T., and Jehle, J. A. (2008) 

Effects of transgenic corn and Cry1Ab protein on the nematode, Caenorhabditis 

elegans. Ecotoxicology and Environmental Safety, 70(2), 334-340.

Houtcooper, W. C. (1978) Food Habits of Rodents in a Cultivated Ecosystem. Journal of 

Mammalogy, 59(2), 427-430.

Hutchison, W. D., Burkness, E. C., Mitchell, P. D., Moon, R. D., Leslie, T. W., Fleischer, 

S. J., Abrahamson, M., Hamilton, K. L., Steffey, K. L., Gray, M. E., Hellmich, R. 

L., Kaster, L. V., Hunt, T. E., Wright, R. J., Pecinovsky, K., Rabaey, T. L., Flood, 

B. R., and Raun, E. S. (2010) Areawide Suppression of European Corn Borer with 

Bt Maize Reaps Savings to Non-Bt Maize Growers. Science, 330(6001), 222-225.

Icoz, I., D. Saxena, D. A. Andow, C. Zwahlen, and G. Stotzky. (2008) Microbial 

populations and enzyme activities in soil in situ under transgenic corn expressing 

Cry proteins for Bacillus thuringiensis. Journal of Environmental Quality 37, 

647-662.

IPCC. (2007).14.4.4 Agriculture, forestry and fisheries. Cambridge University Press, 

Cambridge, United Kingdom and New York, NY, USA. Last accessed 

from http://www.ipcc.ch/publications_and_data/ar4/wg2/en/ch14s14-4-4.html

IPPC (2010). Official web site for the International Plant Protection Convention: 

International Phytosanitary Portal International Plant Protection Convention. 

Retrieved April 18, 2011 from https://www.ippc.int/IPP/En/default.jsp

James, C. (2009) Global status of commercialized biotech/GM crops: 2009 (Report: No. 

41). Ithaca, NY: Retrieved 

from http://www.isaaa.org/resources/publications/briefs/41/
75

Lal, R.and Bruce, J. P. (1999) The potential of world cropland soils to sequester C and 

mitigate the greenhouse effect. Environmental Science & Policy, 2(2), 177-185.

Lawhorn, C. N., Neher, D. A., and Dively, G. P. (2009) Impact of coleopteran targeting 

toxin (Cry3Bb1) of Bt corn on microbially mediated decomposition. Applied Soil 

Ecology, 41(3), 364-368.

Leep, R., Undersander, D., Doo-Hong, M., Harrigan, T., and Grigar, J. (2003) Steps to 

Successful No-till Establishment of Forages (Report: Lansing, MI: Michigan State 

University Extension. 

Leonard, R. (2011, March 14, 2011). [RE: Another question regarding Bt soybeans 

(Personal Communication)].

Loux, M. M., Dobbels, A. F., Stachler, J. M., Johnson, W. G., Nice, G., and Bauman, T. 

T. (2008) "Weed Control Principles" (Report: Retrieved 

from http://ohioline.osu.edu/b789/index.html

Lovett, S., Price, P., and Lovett, J. (2003). Managing Riparian Lands in the Cotton 

Industry. Cotton Research and Development Corporation. Retrieved 

from http://live.greeningaustralia.org.au/nativevegetation/pages/pdf/Authors%20L

/18_Lovett_Price.pdf

Lubowski, R. N., Vesterby, M., Bucholtz, S., Baez, A., and Roberts, M. J. (2006).Major 

Uses of Land in the United States, 2002. USDA, Washington, DC. Last accessed 

from http://www.ers.usda.gov/publications/eib14/

Mallory-Smith, C.and Zapiola, M. (2008) Gene flow from glyphosate-resistant crops. 

[Review]. Pest Management Science, 64(4), 428-440.

Marvier, M., M. McCreedy, J. Regetz, and P. Kareival. . . (2007) A meta-analysis of 

effectsof Bt cotton and maize on nontarget invertebrates. . Science 316, 1475-

1477.

McPherson, R., Wells, M., and Bundy, C. (2001) Impact of the early soybean production 

system on arthropod pest populations in Georgia. Environmental Entomology, 

30(1), 76-81.

Mendelsohn, M., Kough, J., Vaituzis, Z., and Matthews, K. (2003) Are Bt crops safe? 

[10.1038/nbt0903-1003]. Nat Biotech, 21(9), 1003-1009.

Monsanto (2010). Petition for the Determination of Nonregulated Status for MON 87701. 

Submitted by Q. Zhu, Q. Zhu. Monsanto Company, St. Louis, MO (See 

Table http://www.aphis.usda.gov/biotechnology/not_reg.html).

Musser, F. R.and Catchot, A. L. (2008) Mississippi soybean insect losses. Missouth 

Entomologist, 1, 29 - 36.

Musser, F. R., Steward, S. D., and Catchot, A. L. (2009) 2008 Soybean Insect Losses for 

Mississippi and Tennessee. Missouth Entomologist, 2, 42 - 46.

NAPPO (2009). RSPM: 14 Importation and Release into the Environment of Transgenic 

Plants in NAPPO Member Countries North American Plant Protection 

Organization. Retrieved April 18, 2011 

from http://www.nappo.org/Standards/Standards(all)/RSPM14-20-10-03-e.pdf

Naranjo, S., G. Head, and G. Dively. (2005) Special section introduction: field studies 

assessing arthropod non-target effects in Bt transgenic crops. . Environ. Entomol., 

34:, 1178-1180.

.
76

Naranjo, S. E. (2005b. ) Long-term assessment of the effects of transgenic Bt cotton on 

thefunction of the natural enemy community. Environm. Entomol. , 34:, 1211-

1223.

National Information System for the Regional IPM Centers, N. (Producer). (2005a). Crop 

Profile for Soybeans in Mississippi. Crop Profiles and Timelines. Retrieved 

from http://www.ipmcenters.org/cropprofiles/docs/mssoybeans.pdf

National Information System for the Regional IPM Centers, N. (Producer). (2005b, April 

1, 2011). Crop Profile for Soybeans in North Carolina. Crop Profiles and 

Timelines. Retrieved 

from http://www.ipmcenters.org/CropProfiles/docs/NCsoybeans.pdf

NBII (2010). United States Regulatory Agencies Unified Biotechnology Website 

Retrieved 2011 from http://usbiotechreg.nbii.gov/

NCAT. (2003). NCAT's Organic Crops Workbook: A Guide to Sustainable and Allowed 

Practices. National Center for Appropriate Technology. Retrieved 

from http://www.attra.org/attra-pub/PDF/cropsworkbook.pdf

NCCIA (2011). Soybeans: Specific Certification Standards North Carolina Crop 

Improvement Association. Retrieved April, 2011 

from http://www.nccrop.com/files/Soybean%20Certification%20Standards.pdf

Non-GMO-Project (2010). Non-GMO Project Working Standard. Retrieved 

from http://www.nongmoproject.org/wp-content/uploads/2009/06/NGP-Standardv7.pdf

NRC. (2004) Safety of Genetically Engineered Foods: Approaches to Assessing 

Unintended Health Effects (Report: Washington DC: National Resource Council. 

Oliveira, A., Castro, T., Capalbo, D., and Delalibera, I. (2007) Toxicological evaluation 

of genetically modified cotton (Bollgard®) and Dipel® WP on the non-target soil 

mite Scheloribates praeincisus (Acari: Oribatida). Experimental and Applied 

Acarology, 41(3), 191-201.

Pilcher, C. D., Obrycki, J. J., Rice, M. E., and Lewis, L. C. (1997) Preimaginal 

Development, Survival, and Field Abundance of Insect Predators on Transgenic 

Bacillus thuringiensis Corn. Environmental Entomology, 26, 446-454.

Priestley, A.and Brownbridge, M. (2009) Field trials to evaluate effects of Bt-transgenic 

silage corn expressing the Cry1Ab insecticidal toxin on non-target soil arthropods 

in northern New England, USA. Transgenic Research, 18(3), 425-443.

Purves, W., Sadava, D., Orians, G., and Heller, H. (2004). Life: The science of biology. 

Sinauer Associates and W. H. Freeman & Company, Gordonsville, VA.

Ray, J. D., Kilen, T. C., Abel, C. A., and Paris, R. L. (2003) Soybean natural crosspollination rates under field conditions. Environmental Biosafety Research, 2(2), 

133-138.

Romeis, J., Driesche, R. G., Barratt, B. I. P., and Bigler, F. (2008). Insect-Resistant 

Transgenic Crops and Biological Control. In J. Romeis, A. M. Shelton & G. G. 

Kennedy (Eds.), Integration of Insect-Resistant Genetically Modified Crops 

within IPM Programs (Vol. 5, pp. 87-117): Springer Netherlands.

Romeis, J., Dutton, A., and Bigler, F. (2004) Bacillus thuringiensis toxin (Cry1Ab) has 

no direct effect on larvae of the green lacewing Chrysoperla carnea (Stephens) 

(Neuroptera: Chrysopidae). Journal of Insect Physiology, 50(2-3), 175-183.
77

Romeis, J., Meissle, M., and Bigler, F. (2006) Transgenic crops expressing Bacillus 

thuringiensis toxins and biological control. [10.1038/nbt1180]. Nat Biotech, 

24(1), 63-71.

Ronald, P.and Fouche, B. (2006). Genetic Engineering and Organic Production Systems. 

University of California, Division of Agriculture and Natural Resources. 

Retrieved Publication 8188, from http://ucanr.org/freepubs/docs/8188.pdf

Rose, R.and Dively, G. P. (2007) Effects of Insecticide-Treated and Lepidopteran-Active 

Bt Transgenic Sweet Corn on the Abundance and Diversity of Arthropods. 

Environmental Entomology, 36(5), 1254-1268.

Rosenzweig, C.and Parry, M. L. (1994) Potential impact of climate change on world food 

supply. [10.1038/367133a0]. Nature, 367(6459), 133-138.

Roucan-Kane, M.and Gray, A. (2009) The U.S. seed industry: An exploration of statistics 

highlighting the economic activity of the U.S. row crop seed industry (Report: 

Purdue University, Department of Agricultural Economics. Retrieved 

from http://ageconsearch.umn.edu/bitstream/52549/2/09.08.pdf

Rufty, T., Israel, D., Volk, R., Qiu, J., and Tongman, S. (1993) Phosphate Regulation of 

Nitrate Assimilation in Soybean. Journal of Experimental Botany, 44(5), 879-891.

Sanvido, O., Romeis, J., and Bigler, F. (2007). Ecological Impacts of Genetically 

Modified Crops: Ten Years of Field Research and Commercial Cultivation. In A. 

Fiechter & C. Sautter (Eds.), Green Gene Technology (Vol. 107, pp. 235-278): 

Springer Berlin / Heidelberg.

Saxena, D., Flores, S., and Stotzky, G. (1999) Transgenic plants: Insecticidal toxin in root 

exudates from Bt corn. [10.1038/44997]. Nature, 402(6761), 480-480.

Saxena, D.and Stotzky, G. (2001) Bacillus thuringiensis (Bt) toxin released from root 

exudates and biomass of Bt corn has no apparent effect on earthworms, 

nematodes, protozoa, bacteria, and fungi in soil. Soil Biology and Biochemistry, 

33(9), 1225-1230.

Schmidhuber, J.and Tubiello, F. N. (2007) Global food security under climate change. 

Proceedings of the National Academy of Sciences, 104(50), 19703-19708.

Shen, R., Cai, H., and Gong, W. (2006) Transgenic Bt cotton has no apparent effect on 

enzymatic activities or functional diversity of microbial communities in 

rhizosphere soil. Plant and Soil, 285(1), 149-159.

Shimada, N., Miyamoto, K., Kanda, K., and Murata, H. (2006a) Binding of Cry1Ab 

toxin, a Bacillus thuringiensis insecticidal toxin, to proteins of the bovine 

intestinal epithelial cell: An in vitro study. Applied Entomology and Zoology, 

41(2), 295-301.

Shimada, N., Murata, H., Mikami, O., Yoshioka, M., Guruge, K. S., Yamanaka, N., 

Nakajima, Y., and Miyazaki, S. (2006b) Effects of Feeding Calves Genetically 

Modified Corn Bt11: A Clinico-Biochemical Study. The Journal of Veterinary 

Medical Science, 68(10), 1113-1115.

Showalter, A. M., Heuberger, S., Tabashnik, B. E., and Carrière, Y. (2009) A primer for 

using transgenic insecticidal cotton in developing countries. Journal of Insect 

Science (Madison), 9, 22.

Sivasupramaniam, S., Moar, W. J., Ruschke, L. G., Osborn, J. A., Jiang, C., Sebaugh, J. 

L., Brown, G. R., Shappley, Z. W., Oppenhuizen, M. E., Mullins, J. W., and 

Greenplate, J. T. (2008) Toxicity and Characterization of Cotton Expressing 
78

Bacillus thuringiensis Cry1Ac and Cry2Ab2 Proteins for Control of Lepidopteran 

Pests. Journal of Economic Entomology, 101(2), 546-554.

Smirnoff, W. A.and MacLeod, C. F. (1961) Study of the survival of Bacillus 

thuringiensis var. thuringensis Berliner in the digestive tracts and in feces of a 

small mammal and birds. J Invert Pathol, 3, 266 - 270.

Southwood, T. R. E.and Way, M. J. (1970). Ecological background to pest management 

Concepts of Pest Management (pp. 7-28). Raleigh: N.C. State University.

SoyStats (2010a). U.S. Soybean Meal Production 1984-2009. American Soybean 

Association. Retrieved from http://www.soystats.com/2010/page_19.htm

SoyStats (2010b). U.S. Soybean Use by Livestock 2009. American Soybean Association. 

Retrieved from http://www.soystats.com/2010/page_20.htm

Stewart, C. N., Halfhill, M. D., and Warwick, S. I. (2003) Transgene introgression from 

genetically modified crops to their wild relatives. [10.1038/nrg1179]. Nat Rev 

Genet, 4(10), 806-817.

Sun, C., Chen, L., Wu, Z., Zhou, L., and Shimizu, H. (2007) Soil persistence of 

<i>Bacillus thuringiensis</i> (Bt) toxin from transgenic Bt cotton 

tissues and its effect on soil enzyme activities. Biology and Fertility of Soils, 

43(5), 617-620.

Sundstrom, F. J., Williams, J., Van Deynze, A., and Bradford, K. J. (2002). Identity 

Preservation of Agricultural Commodities. University of California, Division of 

Agriculture and Natural Resources. Retrieved Publication 8077, 

from http://www.anrcatalog.ucdavis.edu/

Torres, J.and Ruberson, J. (2006) Interactions of Bt-cotton and the omnivorous big-eyed 

bug Geocoris punctipes (Say), a key predator in cotton fields. Biological Control, 

39(1), 47-57.

Torres, J. B.and Ruberson, J. R. (2005) Canopy- and Ground-Dwelling Predatory 

Arthropods in Commercial Bt and non-Bt Cotton Fields: Patterns and 

Mechanisms. Environmental Entomology, 34(5), 1242-1256.

Tyson, K. S., Bozell, J., Wallace, R., Petersen, E., and Moens, L. (2004) Biomass oil 

analysis: Research needs and recommendations (Report: NREL/TP-510-34796). 

National Renewable Energy Laboratory. Retrieved from 

U.S. EPA. (2011).Plant-Incorporated Protectant Label, Mon 87701, LepidopteranProtected Soybean. Washington, D.C. Last accessed from 

UK Cooperative Extension Service (2005). Estimating Soybean Yield. University of 

Kentucky - College of Agriculture. Retrieved 

from http://www.ca.uky.edu/agc/pubs/agr/agr188/agr188.pdf

UMD (2009). 2009-2010 Pest Management Recommendations for Field Crops University 

of Maryland, College of Agriculture and Natural Resources. Retrieved April, 

2011 from http://extension.umd.edu/publications/eb237online/index.cfm

University of Missouri Extension (1993). Table 1, Weights per bushel William J. 

Murphy, Department of Agronomy. Retrieved May 18, 2011, 

from http://extension.missouri.edu/publications/DisplayPub.aspx?P=G4020

Bacillus thuringiensis subspecies kurstaki Cry IAc and the genetic material necessary for 

its production in all plants; exemption from the requirement of a tolerance on all 

raw agricultural commodities, 62FR 17720 C.F.R. (1997).
79

US-EPA. (2005).Bt Cry1F/Cry1Ac Widestrike Cotton Registration Action Document. 

U.S. Environmental Protection Agency, Washington DC. Last accessed 

from http://www.epa.gov/opp00001/biopesticides/ingredients/tech_docs/brad_006

512.pdf

US-EPA. (2008a).Biopesticides Registration Action Document Bacillus thuringiensis 

modified Cry1Ab (SYN-IR67B-1) and Vip3Aa19 (SYN-IR102-7) insecticidal 

proteins and the genetic material necessary for their production in COT102 

XCOT67B cotton. U.S. Environmental Protection Agency, Office of Pesticide 

Programs, Biopesticides and Pollution Prevention Division, Washington, D.C. 

Last accessed 

from http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_006

529.pdf

US-EPA. (2008b).Current & Previously Registered Section 3 PIP Registrations. Last 

accessed from http://www.epa.gov/oppbppd1/biopesticides/pips_list.htm

US-EPA (2008c). Insect Resistance Management Fact Sheet for Bacillus thuringiensis 

(Bt) Corn Products United States Environmental Protectin Agency. Retrieved 

April 18, 2011 

from http://www.epa.gov/oppbppd1/biopesticides/pips/bt_corn_refuge_2006.htm 

US-EPA. (2010a).Biopesticide Registration Action Document:Bacillus thuringiensis

Cry1Ac Protein and the Genetic Material (Vector PV-GMIR9) Necessary for Its 

Production in MON 87701 (OECD Unique Identifier: MON 877Ø1-2) Soybean 

[PC Code 006532]. U.S. Environmental Protection Agency, Office of Pesticide 

Programs, Biopesticides and Pollution Prevention Division, Washington, D.C. 

Last accessed from http://www.epa.gov/oppbppd1/biopesticides/pips/bt-cry1acprotien.pdf

US-EPA (2010b). Draft 2010 Inventory of Greenhouse Gas Emissions and Sinks 

Executive Summary United States Environmental Protection Agency. Retrieved 

March 30, 2010 from http://www.epa.gov/climatechange/emissions/

US-EPA (2010c). Inventory of U.S. greenhouse gas emissions and sinks: 1990-2008 U.S. 

Environmental Protection Agency. Retrieved March, 2011 

from http://www.epa.gov/climatechange/emissions/downloads10/US-GHGInventory-2010_Report.pdf

U.S. EPA. (2011).Plant-Incorporated Protectant Label, Mon 87701, LepidopteranProtected Soybean. Washington, D.C. 

US-NARA (2010). Executive Orders disposition tables index United States National 

Archives and Records Administration. Retrieved March 11, 2010 

from http://www.archives.gov/federal-register/executive-orders/disposition.html

USB (2007). Market View Database Report. Domestic Findings Retrieved 

from http://www.unitedsoybean.org/library/market_view_database.aspx

USDA-AMS (2010). National Organic Program Agricultural Marketing Service United 

States Department of Agriculture. Retrieved June 4, 2010 

from http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004443

&acct=nopgeninfo

USDA-APHIS. (2005).Reducing Feral Hog Damage through an Integrated Wildlife 

Damage Management Program in the State of Georgia. U.S. Department of 

Agriculture - Animal and Plant Health Inspection Service, Riverdale, MD.
80

USDA-APHIS. (2007).Finding of No Significant Impact, Animal and Plant Health 

Inspection Service, Petition of Non-regulated Status for Soybean Line MON 

89788 (APHIS 06-178-01p). United States Department of Agriculture - Animal 

and Plant Health Inspection Service, Washington DC. Last accessed 

from http://www.aphis.usda.gov/brs/aphisdocs2/06_17801p_com.pdf

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

States Department of Agriculture, Animal and Plant Health Inspection Service, 

Riverdale, MD. Last accessed from 

USDA-APHIS (2011b). Petitions for Nonregulated Status Granted or Pending by APHIS 

United States Department of Agriculture - Animal and Plant Health Inspection 

Service. Retrieved April, 2011 

from http://www.aphis.usda.gov/biotechnology/not_reg.html

USDA-ERS (2005). Agricultural Chemicals and Production Technology: Sustainability 

and Production Systems Retrieved May 22, 2010 

from http://www.ers.usda.gov/Briefing/AgChemicals/sustainability.htm

USDA-ERS (2010a). Adoption of Genetically Engineered Crops in the U.S.: Soybean 

Varieties United States Department of Agriculture - Economic Research Service. 

Retrieved April, 2011 

from http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable3.htm

USDA-ERS (2010b). Organic Production Retrieved February 2011, 

from http://www.ers.usda.gov/Data/Organic/

USDA-ERS. (2011).USDA Agricultural Projections to 2020. USDA, Office of the Chief 

Economist, World Agricultural Outlook Board, Washington, D.C. Last accessed 

from http://usda.mannlib.cornell.edu/MannUsda/viewStaticPage.do?url=http://usd

a.mannlib.cornell.edu/usda/ers/94005/./2011/index.html

USDA-FAS. (2011). Global Agricultural Trade Systems Online. Retrieved April, from 

United States Department of Agriculture - Foreign Agricultural 

Service http://www.fas.usda.gov/gats/default.aspx

USDA-NASS. (2007).Agricultural Chemical Usage 2006 Field Crops Summary. Last 

accessed 

from http://usda.mannlib.cornell.edu/usda/nass/AgriChemUsFC//2000s/2007/Agri

ChemUsFC-05-16-2007_revision.pdf

USDA-NASS. (2009).2008 Organic Survey. Washington, D.C. Last accessed 

from http://www.agcensus.usda.gov/Publications/2007/Online_Highlights/Organi

cs/organics_1_07.pdf

USDA-NASS (2010). Acreage. United States Department of Agriculture - National 

Agriculture Statistics Service. Retrieved 

from http://usda.mannlib.cornell.edu/usda/current/Acre/Acre-06-30-2010.pdf

USDA-NASS. (2011a).Crop Production 2010 Summary: January 2011. United States 

Department of Agriculture - National Agricultural Statistics Service, Washington, 

D.C. Last accessed March 31, 2011, 

from http://usda.mannlib.cornell.edu/usda/current/CropProdSu/CropProdSu-01-

12-2011_new_format.pdf

USDA-NASS. (2011b). Statistics by Subject - National Statistics for Soybeans. 

Retrieved March 31, 2011, from United States Department of Agriculture -

National Agricultural Statistics Service 
81

http://www.nass.usda.gov/Statistics_by_Subject/result.php?02724256-DFB8-

3BB1-953C4E665A5E7612§or=CROPS&group=FIELD%20CROPS&comm=SOYBEA

NS

USF&WS (1999). Delmarva Peninsula Fox Squirrel. U.S. Fish & Wildlife Service. 

Retrieved from http://www.scarysquirrel.org/vacation/delmarva/foxsquirrel.pdf

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

proteins. Journal of Invertebrate Pathology, 101(1), 1-16.

Van Rie, J., Jansens, S., Hofte, H., Degheele, D., and Van Mellaert, H. (1990) Receptors 

on the brush border membrane of the insect midgut as determinants of the 

specificity of Bacillus thuringiensis delta-endotoxins. Appl. Environ. Microbiol., 

56(5), 1378-1385.

Vogel, J. R., Majewski, M. S., and Capel, P. D. (2008) Pesticides in Rain in Four 

Agricultural Watersheds in the United States. J. Environ. Qual., 37(3), 1101-

1115.

Wallace, S. U., Palmer, J. H., Barnes, J. M., Francoeur, L. C., and Yarrow, G. K. (1996) 

Strategies for reducing deer damage to soybeans (Report: Clemson University 

Cooperative Extension. 

Way, M. O. (1994). Status of soybean insect pests in the United States. In L. G. Higley & 

H. R. Boerma (Eds.), Handbook of soybean insect pests. Lanham, MD: 

Entomological Society of America.

Weiner, J., Griepentrog, H.-W., and Kristensen, L. (2001) Suppression of Weeds by 

Spring Wheat Triticum aestivum Increases with Crop Density and Spatial 

Uniformity. Journal of Applied Ecology, 38(4), 784-790.

Whitehouse, M. E. A., Wilson, L. J., and Fitt, G. P. (2005) A Comparison of Arthropod 

Communities in Transgenic Bt and Conventional Cotton in Australia. 

Environmental Entomology, 34, 1224-1241.

Wilson, E. (1988). Biodiversity. National Academy Press, Washington DC.

Woodruff, J., Whitaker, J., Prostko, E., Roberts, P., Kemerait, R., Smith, N., Smith, A., 

Sumner, P., Harrison, K., and Harris, G. (2010) Soybean Weed Control (Report: 

University of Georgia College of Agriculture and Environmental Sciences. 

Retrieved 

from http://www.caes.uga.edu/commodities/fieldcrops/soybeans/documents/Com

piled2010SoybeanProductionGuide.pdf

Yoshimura, Y., Matsuo, K., and Yasuda, K. (2006) Gene flow from GM glyphosatetolerant to conventional soybeans under field conditions in Japan. [Comparative 

Study]. Environmental Biosafety Research, 5(3), 169-173.

Zapiola, M. L., Campbell, C. K., Butler, M. D., and Mallory-Smith, C. A. (2008) Escape 

and establishment of transgenic glyphosate-resistant creeping bentgrass Agrostis 

stolonifera in Oregon, USA: a 4-year study. Journal of Applied Ecology, 45(2), 

486-494.

Zeilinger, A. R., Andow, D. A., Zwahlen, C., and Stotzky, G. (2010) Earthworm 

populations in a northern U.S. Cornbelt soil are not affected by long-term 

cultivation of Bt maize expressing Cry1Ab and Cry3Bb1 proteins. Soil Biology 

and Biochemistry, 42(8), 1284-1292.
82

Zurbrügg, C., Hönemann, L., Meissle, M., Romeis, J., and Nentwig, W. (2010) 

Decomposition dynamics and structural plant components of genetically modified 

Bt maize leaves do not differ from leaves of conventional hybrids. Transgenic 

Research, 19(2), 257-267.

Zwahlen, C., Hilbeck, A., Howald, R., and Nentwig, W. (2003) Effects of transgenic Bt 

corn litter on the earthworm Lumbricus terrestris. Molecular Ecology, 12(4), 

1077-1086.
83

APPENDIX A - APHIS THREATENED AND ENDANGERED SPECIES 

DECISION TREE FOR FWS CONSULTATIONS

DECISION TREE ON WHETHER SECTION 7 CONSULTATION WITH FWS IS 

TRIGGERED FOR PETITIONS OF TRANSGENIC PLANTS

This decision tree document is based on the phenotypes (traits) that have been permitted 

for environmental releases under APHIS oversight (for a list of approved notifications 

and environmental releases, visit Information Systems for Biotechnology, 

at http://isb.vt.edu.) APHIS will re-evaluate and update this decision document as it 

receives new applications for environmental releases of new traits that are genetically 

engineered into plants.

BACKGROUND

For each transgene(s)/transgenic plant the following information, data, and questions will 

be addressed by APHIS, and the EAs on each petition will be publicly available. APHIS 

review will encompass:

• A review of the biology, taxonomy, and weediness potential of the crop plant and 

its sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and 

the nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are 

produced in the plant and their quantity;

• A review of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact;

• Determination of the concentrations of known plant toxicants (if any are known in 

the plant),

• Analysis to determine if the transgenic plant is sexually compatible with any 

threatened or endangered plant species (TES) or a host of any TES.

FDA published a policy in 1992 on foods derived from new plant varieties, including 

those derived from transgenic plants (http://vm.cfsan.fda.gov/~lrd/fr92529b.html

and http://vm.cfsan.fda.gov/~lrd/consulpr.html ). The FDA’s policy requires that 

genetically engineered foods meet the same rigorous safety standards as is required of all 

other foods. Many of the food crops currently being developed using biotechnology do 

not contain substances that are significantly different from those already consumed by 

human and thus do not require pre-market approval. Consistent with its 1992 policy, 

FDA expects developers to consult with the agency on safety and regulatory questions. A 

list of consultations is available at http://vm.cfsan.fda.gov/~lrd/biocon.html . APHIS 

considers the status and conclusion of the FDA consultations in its EAs.

Below is a description of our review process to whether a consultation with U.S. Fish and 

Wildlife Service is necessary.
84

If the answer to any of the questions 1-4 below is yes, APHIS will contact FWS to 

determine if a consultation is required:

Is the transgenic plant sexually compatible with a TE plant5 without human intervention?

1. Are naturally occurring plant toxins (toxicants) or allelochemicals increased over 

the normal concentration range in parental plant species?

2. Does the transgene product or its metabolites have any significant similarities to 

known toxins6?

3. Will the new phenotype(s) imparted to the transgenic plant allow the plant to be 

grown or employed in new habitats (e.g., outside agro-ecosystem)7.

4. Does the pest resistance8 gene act by one of the mechanisms listed below? If the 

answer is YES then a consultation with U.S. Fish and Wildlife Service is NOT 

necessary.

A. The transgene acts only in one or more of the following ways:

i. As a structural barrier to either the attachment of the pest to the host, to 

penetration of the host by the pest, to the spread of the pest in the host plant 

(e.g., the production of lignin, callose, thickened cuticles);

ii. In the plant by inactivating or resisting toxins or other disease causing 

substances produced by the pest;

iii. By creating a deficiency in the host of a component required for growth of the 

pest (such as with fungi and bacteria);

iv. By initiating, enhancing, or potentiating the endogenous host hypersensitive 

disease resistance response found in the plant;

v. In an indirect manner that does not result in killing or interfering with normal 

growth, development, or behavior of the pest;

B. A pest derived transgene is expressed in the plant to confer resistance to that pest 

(such as with coat protein, replicase, and pathogen virulence genes).

For the biotechnologist:

 5 APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to the TES 

plant

6 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein 

databases like PIR, Swiss-Prot and HIV amino acid data bases. 7 Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, aluminum 

or heavy metals.

8 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels or mitigates a 

pest or effects any vertebrate or invertebrate animal, plant, or microorganism.
85

Depending on the outcome of the decision tree, initial the appropriate decision 

below and incorporate its language into the EA. Retain a hard copy of this decision 

document in the petition’s file.

________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as required 

under Section 7 of the Endangered Species Act, is needed. APHIS has reached a 

determination that the release following a determination of non-regulated status would 

have no effects on listed threatened or endangered species and consequently, a written 

concurrence or formal consultation with the Fish and Wildlife Service is not required for 

this EA.

________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as required 

under Section 7 of the Endangered Species Act, is needed. APHIS reached a 

determination that the release following a determination of non-regulated status is not 

likely to adversely affect any listed threatened or endangered species and consequently 

obtained written concurrence from the Fish and Wildlife Service.

________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as required 

under Section 7 of the Endangered Species Act, is needed. APHIS reached a 

determination that the release following a determination of non-regulated status is likely 

to affect adversely one or more listed threatened or endangered species and has initiated a 

formal consultation with the Fish and Wildlife Service.