Monsanto Improved Fatty Acid Profile 

MON 87705 Soybean, Petition 09-201-01p 

OECD Unique Identifier: 

MON-87705-6 

Draft Environmental Assessment 

April 2011 

Agency Contact 

Cindy Eck 

USDA, APHIS, BRS 

4700 River Road, Unit 147 

Riverdale, MD 20737-1237 

Phone: (301) 734-0667 

Fax: (301) 734-8669 

Cynthia.A.Eck@aphis.usda.gov 

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opportunity provider and employer. 

 

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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. 

 

 

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DRAFT MONSANTO 87705 SOYBEAN 

TABLE OF CONTENTS PAGE 

 i 

ACRONYMS ................................................................................................................................ iv 

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

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

1.2 REGULATED ORGANISMS ...................................................................................................... 2

1.3 PETITION FOR DETERMINATION OF NONREGULATED STATUS: IMPROVED 

FATTY ACID PROFILE MONSANTO 87705 SOYBEAN ....................................................... 2

1.4 PURPOSE OF PRODUCT ........................................................................................................... 3

1.5 APHIS RESPONSE TO PETITION FOR NONREGULATED STATUS .................................. 4

1.6 COORDINATED FRAMEWORK REVIEW .............................................................................. 4

1.7 PUBLIC INVOLVEMENT .......................................................................................................... 5

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

2.1 SOYBEAN BIOLOGY, USE, AND COMPOSITION ................................................................ 7

2.1.1 Soybean Taxonomy ............................................................................................................... 7

2.1.2 Soybean Use and Composition ............................................................................................. 7

2.1.2.1 Soybean Use .................................................................................................................. 8

2.1.2.2 Soybean Composition ................................................................................................... 8

2.1.3 Cultivation of GE Soybeans ................................................................................................ 11

2.2 SOYBEAN PRODUCTION ....................................................................................................... 11

2.2.1 Acreage and Areas of Soybean Production ......................................................................... 11

2.2.2 Seed Production .................................................................................................................. 12

2.2.3 Organic Farming ................................................................................................................. 14

2.2.4 Specialty Soybean Production ............................................................................................ 15

2.2.5 Soybean Cultivation Practices ............................................................................................ 17

2.2.5.1 Pre-Season Preparation ............................................................................................... 18

2.2.5.2 Planting and Early Season ........................................................................................... 18

2.2.5.3 Mid- to Late Season .................................................................................................... 18

2.2.5.4 Harvest Season ............................................................................................................ 18

2.2.5.5 Soybean Crop Rotation and Control of Volunteers .................................................... 19

2.3 PHYSICAL ENVIRONMENT ................................................................................................... 20

2.3.1 Soil and Land Use ............................................................................................................... 20

2.3.2 Water Resources ................................................................................................................. 22

2.3.3 Air Quality and Climate Change ......................................................................................... 22

2.4 BIOLOGICAL RESOURCES .................................................................................................... 23

2.4.1 Gene Movement and Weediness ......................................................................................... 24

2.4.2 Animals ............................................................................................................................... 26

2.4.3 Plants ................................................................................................................................... 26

2.4.4 Microorganisms .................................................................................................................. 29

2.4.5 Biodiversity ......................................................................................................................... 30
DRAFT MONSANTO 87705 SOYBEAN 

TABLE OF CONTENTS, CONTINUED PAGE 

 ii 

2.5 PUBLIC HEALTH ..................................................................................................................... 31

2.5.1 Worker Safety ..................................................................................................................... 31

2.5.2 Human Health ..................................................................................................................... 32

2.6 ANIMAL FEED .......................................................................................................................... 32

2.7 SOCIOECONOMIC ISSUES ..................................................................................................... 33

3 ALTERNATIVES ................................................................................................................ 36

3.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE ......................................... 36

3.2 PREFERRED ALTERNATIVE: DETERMINATION THAT MON 87705 SOYBEAN IS NO 

LONGER A REGULATED ARTICLE ..................................................................................... 36

3.3 ALTERNATIVES CONSIDERED BUT REJECTED FROM FURTHER CONSIDERATION

 .................................................................................................................................................... 37

3.3.1 Prohibit Any MON 87705 Soybean from Being Released ................................................. 37

3.3.2 Approve the petition in part ................................................................................................ 38

3.3.3 Isolation Distance between MON 87705 Soybean and Non-GE Soybean Production and 

Geographic Restrictions ..................................................................................................... 38

3.3.4 Requirement of Testing for MON 87705 Soybean ............................................................. 38

4 ENVIRONMENTAL CONSEQUENCES ......................................................................... 41

4.1 SOYBEAN PRODUCTION ....................................................................................................... 42

4.1.1 Acreage and Areas of Soybean Production ......................................................................... 42

4.1.2 Seed Production .................................................................................................................. 43

4.1.3 Organic Farming ................................................................................................................. 44

4.1.4 Specialty Soybean Production ............................................................................................ 46

4.1.5 Soybean Cultivation Practices ............................................................................................ 47

4.2 PHYSICAL ENVIRONMENT ................................................................................................... 49

4.2.1 Soil and Land Use ............................................................................................................... 49

4.2.2 Water Resources ................................................................................................................. 51

4.2.3 Air Quality and Climate Change ......................................................................................... 52

4.3 BIOLOGICAL RESOURCES .................................................................................................... 53

4.3.1 Gene Movement and Weediness ......................................................................................... 53

4.3.2 Animals ............................................................................................................................... 56

4.3.3 Plants ................................................................................................................................... 58

4.3.4 Microorganisms .................................................................................................................. 60

4.3.5 Biodiversity ......................................................................................................................... 61

4.4 PUBLIC HEALTH ..................................................................................................................... 63

4.4.1 Worker Safety .................................................................................................................... 63

4.4.2 Human Health .................................................................................................................... 64

4.5 ANIMAL FEED .......................................................................................................................... 68

4.6 SOCIOECONOMIC ISSUES ..................................................................................................... 70

4.6.1 Domestic Economic Environment at Risk .......................................................................... 70
DRAFT MONSANTO 87705 SOYBEAN 

TABLE OF CONTENTS, CONTINUED PAGE 

 iii 

4.6.2 Trade Economic Environment at Risk ................................................................................ 77

4.6.3 Social Environment at Risk ................................................................................................. 80

4.7 THREATENED AND ENDANGERED SPECIES .................................................................... 82

4.8 OTHER CUMULATIVE EFFECTS .......................................................................................... 86

4.9 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS .................................................................... 87

4.9.1 Executive Orders with Domestic Implications ................................................................... 87

4.9.2 International Implications ................................................................................................... 90

4.9.3 Compliance with Clean Water Act and Clean Air Act ....................................................... 91

4.9.4 Impacts on Unique Characteristics of Geographic Areas ................................................... 91

4.9.5 National Historic Preservation Act (NHPA) of 1966 as Amended ..................................... 92

5 BIBLIOGRAPHY ................................................................................................................ 93

APPENDICES 

Appendix A FDA Consultation on Bioengineered Foods – Mon 87705 Soybean 

Appendix B APHIS Threatened and Endangered Species Decision Tree for FWS 

Consultations 

Appendix C Threatened and Endangered Species State Lists 

Appendix D Addendum 1 to the Petition. Market Impact of MON 87705 High Oleic Soybean 

Oil. Monsanto Petition No. 09-SY-201U 

LIST OF TABLES PAGE 

Table 2-1 Fatty Acid Composition of Conventional Soybean Oil ...........................................9 

Table 2-2 Soybean Acreage by State, 2009 and 2010 ............................................................12 

Table 2-3 U.S. Glyphosate-Resistant Weeds through March 2011 .......................................28 

Table 2-4 World Soybean Production 2009 ...........................................................................33 

Table 2-5 Properties of Select Fatty Acids .............................................................................34 

Table 3-1 Summary of Potential Impacts and Consequences of Alternatives .......................39 

Table 4-1 Comparison of Fatty Acid Profiles of MON 87705 Soybean with Several Other 

Plant Sources ..........................................................................................................58 

Table 4-2 Comparison of Targeted Fatty Acid Levels in MON 87705 Soybean with 

Conventional Soybean Control (A3525) and Commercial Tolerance Intervals ....66 

Table 4-3 U.S. Vegetable Oil Prices (dollars/gallon) .............................................................76 
DRAFT MONSANTO 87705 SOYBEAN 

ACRONYMS 

 iv 

AIA advanced informed agreement

AMS Agricultural Marketing Service

AOSCA Association of Official Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BRS Biotechnology Regulatory Service

CBD Convention on Biological Diversity

CEQ Council of Environmental Quality

CFIA Canadian Food Inspection Agency

CFR Code of Federal Regulations

CIBIOGEM Intersectoral Commission for Biosafety of Genetically Modified Organisms

COGEM Commissie Genetische Modificatie

cp4 epsps 5-enolpyruvylshikimate-3-phosphate synthase

CRP crop reserve program

DNA Deoxyribonucleic acid

EA environmental assessment

ECOS Environmental Conservation Online

EFSA European Food Safety Agency

EFSA European Food Safety Authority

EIS Environmental impact statement

EO Executive Order 

EPA Environmental Protection Agency

ESA Endangered Species Act

EU European Union 

FAD2 soybean gene encoding delta-12 desaturase

FATB soybean gene enconding Acyl-ACP thioesterase

FDA 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 

GE genetically engineered

GENOK Norway Center for Biological Safety

GHG greenhouse gas 

GRAS generally recognized as safe

HDL high density lipoprotein

HT herbicide-tolerant 

IDP identity preservation 

ILDIS International Legume Database and Information Services

IPM Integrated Pest Management

LDL low density lipoprotein

LMO living modified organisms

MAFF Ministry of Agriculture, Forestry, and Fisheries

MHLW Ministry of Health, Labor, and Welfare
DRAFT MONSANTO 87705 SOYBEAN 

ACRONYMS, CONTINUED 

 v 

MMT million metric tons 

MOU Memorandum of Understanding

N2O nitrous oxide 

NABI North American Biotechnology Initiative

NEPA National Environmental Policy Act

NHPA National Historic Preservation Act

NMFS National Marine Fisheries Service

NOP National Organic Program

OECD Organization for Economic Co-operation and Development 

OSTP Office of Science and Technology Policy

POEA polyethoxylated alkyl amine

PPA Plant Protection Act 

PRA pest risk analysis

RED Reregistration Eligibility Decision

RNA Ribonucleic acid 

RSPM Regional Standards for Phytosanitary Measures

TES threatened or endangered species

TSCA Toxic Substances Control Act

U.S.C. United States Code 

USDA U.S. Department of Agriculture

USDA-GRIN USDA Germplasm Resources Information Network

USFWS United States Fish and Wildlife Service

WPS Worker Protection Standard
DRAFT MONSANTO 87705 SOYBEAN 

 1 

1 PURPOSE AND NEED 

1.1 REGULATORY AUTHORITY 

“Protecting American agriculture” is the basic charge of the U.S. 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 (GE) varieties) can provide benefits to the environment, consumers, and 

farm income. 

Since 1986, the United States government has regulated genetically engineered (GE) organisms 

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

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

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

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

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

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

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

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

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

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

which it is created; (3) agencies are mandated to exercise oversight 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 Food and Drug Administration (FDA), and the Environmental Protection 

Agency (EPA). 

APHIS is responsible for regulating GE organisms and plants under the plant pest authorities 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. 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 regulatory 

issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food. 
DRAFT MONSANTO 87705 SOYBEAN 

 2 

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

Rodenticide Act (FIFRA) and certain biological control organisms under the Toxic Substances 

Control Act (TSCA). 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. 

1.2 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. 

1.3 PETITION FOR DETERMINATION OF NONREGULATED STATUS: 

IMPROVED FATTY ACID PROFILE MONSANTO 87705 SOYBEAN 

Monsanto Company (Monsanto) has submitted a petition to APHIS seeking a determination that 

Monsanto 87705 Soybean is unlikely to pose a plant pest risk and, therefore, should no longer be 

a regulated article under regulations at 7 CFR Part 340. 

Monsanto has developed a transgenic soybean, event MON 87705 (hereafter referred to as MON 

87705 Soybean), that produces soybean seeds with lower levels of saturated (palmitic and 

stearic) and polyunsaturated (linoleic) fatty acids, and higher levels of monounsaturated (oleic) 

fatty acid than those found in non-modified soybean seeds. MON 87705 Soybean contains DNA 

segments designed to suppress endogenous delta-12 desaturase (FAD2) and Acyl-ACP 

thioesterase (FATB) genes which encode for two enzymes in the soybean fatty acid biosynthetic 

pathway. MON 87705 Soybean also contains the 5-enolpyruvylshikimate-3-phosphate synthase 

(cp4 epsps) gene encoding the CP4 EPSPS protein. The cp4 epsps gene is used as a selectable 
DRAFT MONSANTO 87705 SOYBEAN 

 3 

marker to identify transgenic plants during the transformation process. The CP4 EPSPS protein 

confers tolerance to glyphosate and has been used in many Roundup Ready® crops (e.g., canola, 

corn, cotton, soybean, and sugar beet). 

MON 87705 Soybean is currently regulated under 7 CFR Part 340. Interstate movements, 

importations, and field testing of MON 87705 Soybean have been conducted under notifications 

acknowledged by APHIS. 

MON 87705 Soybean has been field tested at 17 sites in ten states across U.S. soybean 

production regions as authorized by APHIS (Rogan, 2010). Data were provided in the petition 

for field trials completed prior to the petition submission. Field test reports can be found in the 

MON 87705 Soybean petition in several appendices Monsanto has conducted multiple field 

trials under field release authorizations granted by USDA-APHIS in geographically diverse 

regions and conditions throughout the U.S., including Arkansas, Illinois, Iowa, Indiana, Kansas, 

Michigan, Missouri, Nebraska, Ohio, Pennsylvania, and Wisconsin (Rogan, 2010). Field tests 

conducted under APHIS oversight allow for an evaluation of the crop in agricultural settings 

under confinement measures designed to minimize the likelihood of persistence in the 

environment after completion of the field trial. Under confined field trial conditions, data are 

gathered on multiple parameters and used by applicants to evaluate agronomic characteristics 

and product performance. These data are also valuable to APHIS for assessing the potential for a 

new variety to pose a plant pest risk. The data evaluated for MON 87705 Soybean may be found 

in the APHIS Assessment of Plant Pest Risk for MON 87705 Soybean (USDA-APHIS, 2010a). 

1.4 PURPOSE OF PRODUCT 

Monsanto seeks a determination of nonregulated status ofMON 87705 Soybean that is 

genetically enhanced to suppress the endogenous FATB and FAD2 ribonucleic acid (RNA) in the 

developing soybean seed. This enhancement improves the fatty acid profile to contain lower 

saturated (palmitic and stearic) fatty acids, lower polyunsaturated (linoleic) fatty acid levels, and 

higher levels of monounsaturated (oleic) fatty acid (Rogan, 2010). MON 87705 Soybean also 

expresses CP4 EPSPS protein throughout the plant conferring tolerance to glyphosate, which is 

the active ingredient in the Roundup® family of agricultural herbicides. 

Soybean, Glycine max, is grown as a commercial crop in over 35 countries (OECD, 2000). 

Soybean is grown for production of seed which is used for production of oils and meals. Purified 

Soybean oil has many applications in the food and industrial sector, including soy-based 

shortenings and vegetable oils, soaps and disinfectants, and biodiesel sources (OECD, 2000). 

Soybean meal is used as a supplement in feed rations for livestock. 

Historically, the U.S. market for soybean oil was limited by the presence of undesirable offflavors and odors (Rogan, 2010). The double bonds in the polyunsaturated fatty acids are 

susceptible to oxidation resulting in the formation of “fishy” or acrid flavors and odors in 

soybean oil (Dutton, Lancaster, Evans, & Cowan, 1951). Chemical hydrogenation was adopted 

to reduce the concentrations of polyunsaturated fatty acids and prolong the shelf-life of the 

product (Dutton, 1963; Okkerse, De Jonge, Coenen, & Rozendaal, 1967). Hydrogenated 

vegetable oils, including hydrogenated soybean oil, were viewed as viable alternatives to animal 

fats and the high-in-saturated-fats tropical oils, such as palm oil and coconut oil (Rogan, 2010). 
DRAFT MONSANTO 87705 SOYBEAN 

 4 

However, in the 1990s, nutrition research showed that the trans fatty acids created by the 

hydrogenation process had negative health consequences (Judd et al., 1994; Mensink & Katan, 

1990; Zock & Katan, 1992). By 2006, the FDA had issued a regulation obligating food 

manufacturers to declare the trans fatty acid content of their product on nutrition labeling (USFDA, 2006). Because many consumers are attempting to avoid trans fats, there has been a 

decline in soybean oil per capita consumption in the U.S. since 2006 (Soyatech, 2008). 

The MON 87705 Soybean oil fatty acid profile provides new formulation options for food 

companies interested in the development of lower saturated fat food products to support heart 

health. Low saturated fats and high (>70%) oleic acid levels are also key attributes for vegetable 

oils targeted for biodiesel and industrial uses (Rogan, 2010). These characteristics are vital to 

improved cold weather performance, improved stability, and reduced nitrous oxide emissions 

(Graef et al., 2009; Knothe, 2005). In addition to the altered fatty acid profile, the soybeans were 

engineered with glyphosate tolerance to provide growers of these soybeans with weed control 

options as well. 

1.5 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 who request a determination of the 

regulated status of GE organisms, including GE plants such as MON 87705 Soybean. When a 

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

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 (CEQ) regulations implementing NEPA (40 CFR Parts 1500-1508, 7 

CFR 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 on the quality 

of the human environment1 that may result from the deregulation of MON 87705 Soybean. 

1.6 COORDINATED FRAMEWORK REVIEW 

Food and Drug Administration 

MON 87705 Soybean falls within the scope of the 1992 FDA’s policy statement concerning 

regulation of products derived from new plant varieties, including those developed through 

biotechnology (US-FDA, 1992). In compliance with this policy, Monsanto initiated a 

 

1

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

relationship of people with that environment” (40 CFR §508.14). 
DRAFT MONSANTO 87705 SOYBEAN 

 5 

consultation with the FDA on the food and feed safety and nutritional assessment summary for 

MON 87705 Soybean. A copy of the completed FDA review is provided in Appendix A. 

Environmental Protection Agency 

EPA has authority under FIFRA to establish pesticide use restrictions; these use restrictions are 

presented on pesticide labels which are prepared during the pesticide registration process. The 

CP4 EPSPS protein expressed in MON 87705 is similar and functionally identical to endogenous 

plant EPSPS enzymes and is identical to the CP4 EPSPSs in other Roundup Ready® crops 

including Roundup Ready® soybean (40-3-2 and MON 89788). Monsanto indicates that there 

will be no change in the use pattern for glyphosate on this glyphosate tolerant variety and there 

will be no need to petition EPA for a change in the label for glyphosate (G.Rogan, personal 

communication, 2011). APHIS will use current glyphosate labels as the basis for its evaluation 

of the potential impacts associated with the use of and exposure to glyphosate. 

1.7 PUBLIC INVOLVEMENT 

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

deregulate GE organisms. APHIS does this through a notice published in the Federal Register. 

The issues discussed in this EA were developed by considering 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 that have been raised by various stakeholders. These issues, including 

those regarding the agricultural production of soybean using various production methods, and 

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

environmental impacts of MON 87705 Soybean. 

This EA, the petition submitted by Monsanto, and APHIS’s Assessment of Plant Pest Risk for 

MON 87705 Soybean 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 reviewed and used to 

inform APHIS’s determination decision of the regulated status of MON 87705 Soybean and to 

assist APHIS in determining whether an Environmental Impact Statement is required prior to the 

determination decision of the regulated status of these soybean lines. 

ISSUES CONSIDERED 

As stated above, the issues considered in this EA were developed based on APHIS’ 

determination to deregulate certain genetically engineered organisms, and for this particular EA, 

the specific deregulation of MON 87705 Soybean. 

Soybean Production: 

 Acreage and Areas of Soybean Production 

 Seed Production 

 Organic Farming 

 Specialty Soybean Production 

 Soybean Cultivation Practices 
DRAFT MONSANTO 87705 SOYBEAN 

 6 

Environmental Considerations: 

 Soil and Land Use 

 Water Resources 

 Air Quality and Climate Change 

 Gene Movement and Weediness 

 Animals 

 Plants 

 Microorganisms 

 Biodiversity 

Public Health Considerations: 

 Worker Safety 

 Human Health 

Animal Feed 

Socioeconomic Issues: 

 Domestic Economic Environment at Risk 

 Trade Economic Environment at Risk 

 Social Environment at Risk 

Threatened and Endangered Species 

Other Cumulative Effects 

Other U.S. Regulatory Approvals and Compliance with Other Laws 
DRAFT MONSANTO 87705 SOYBEAN 

 7 

2 AFFECTED ENVIRONMENT 

The Affected Environment Section provides an overview of the biology, use, and composition of 

the soybean, followed by a discussion of the current conditions of those aspects of the human 

environment potentially impacted by the deregulation of MON 87705 Soybean. For the purposes 

of this draft EA, those aspects of the human environment are: soybean production practices, the 

physical environment, biological resources, public health, animal feed, and socioeconomic 

issues. 

2.1 SOYBEAN BIOLOGY, USE, AND COMPOSITION 

2.1.1 Soybean Taxonomy 

The taxonomy of soybean is important to the analysis of potential impacts of gene modification. 

The taxonomy of soybean affects the potential for gene transfer, outcrossing, and volunteer 

weediness. 

The Organization for Economic Co-operation and Development (OECD) Consensus Document 

(OECD, 2000) provides detailed information about the crop biology of soybean. The genus 

Glycine consists of two subgenera, soja and glycine. The subgenus soja consists of three annual 

species: G. soja Sieb. and Zucc., the wild form of soybean; G. gracilis Skvortz., the weedy form 

of soybean; and G. max, the cultivated soybean. These species do not occur naturally in the U.S. 

(USDA-NRCS, 2008). 

Glycine soja grows wild in China, Japan, Korea, the Russian Far East, and Taiwan and is 

commonly found in fields, hedgerows, roadsides, and riverbanks (OECD, 2000). 

The taxonomic position of G. gracilis has been an area of debate. Neither International Legume 

Database and Information Service (ILDIS) nor USDA-Germplasm Resources Information 

Network (USDA-GRIN) recognizes G. gracilis as a distinct species. G. gracilis is known only 

from Northeast China, is intermediate in morphology between G. max and G. soja, and is 

sometimes considered a variant of the cultivated soybean, G. max. Cultivated soybean can only 

hybridize with other members of the Glycine subgenus soja (OECD, 2000). The wild and weedy 

relatives (G. soja and G. gracilis) of soybean do not occur in the U.S. (USDA-APHIS, 2010a). 

The subgenus glycine consists of 22 wild perennial species which are indigenous to Australia; 

West, Central and South Pacific Islands; China; Russia; Japan; Indonesia; Korea; Papua New 

Guinea; the Philippines; and Taiwan (Hymowitz, 2004). The Monsanto Petition presents a list of 

the 22 wild species with their respective genomic complement in Table II-2 of the petition. 

The cultivated soybean, G. max, lacks sexually compatible wild relatives in the U.S. and its 

territories. Consequently, there is no potential for gene flow from cultivated soybean plants to 

wild relatives in the U.S. (USDA-APHIS, 2010b). 

2.1.2 Soybean Use and Composition 

The soybean is an economically important leguminous crop providing oil and protein. Soybean 

plants are grown for their seed, which is further processed to yield oil for a variety of uses and 
DRAFT MONSANTO 87705 SOYBEAN 

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meal for human dietary products and livestock feed. Soybean uses in the U.S. include edible 

soybean oil, soy-based biodiesel, animal feed, tofu, and industrial chemicals (SoyStats, 2010d). 

This subsection provides an overview of the various uses and associated composition of soybean. 

2.1.2.1 Soybean Use 

Soybean is used in various food products, including tofu, soybean sauce, soymilk, energy bars, 

and meat products. A significant fraction of the soybean market is dedicated to production of 

purified oil for food use and industrial applications (Cahoon, 2003). Food uses include 

margarines, shortenings, and cooking and salad oils (OECD, 2000). Soybean oil generally has a 

smaller contribution to soybean’s overall value compared to soybean meal because the oil 

constitutes just 18 to 19% of the soybean's weight. Nonetheless, soybean oil accounted for 

approximately 30% of all the vegetable oils consumed globally and was the second largest 

source of vegetable oil worldwide, slightly behind palm oil representing approximately 32% of 

global consumption (Soyatech, 2010). Soybean oil also has industrial applications, including 

feedstock in manufacture of inks, paints, varnishes, resins, plastics, and biodiesel (Cahoon, 2003; 

SoyStats, 2010d). 

Approximately 50% of the world soybean seed supply in 2009 was crushed to produce soybean 

meal and oil (Soyatech, 2008). Most of the seed was used to supply the feed industry for 

livestock use or the food industry for edible vegetable oil and soybean protein isolates. Another 

34% of the world soybean seed supply was traded to other geographies, with China, the 

European Union (EU), Japan, and Mexico being the top soybean seed importers (SoyStats, 

2010a). The remainder of the soybean seed produced was used as certified seed, feed, or stocks. 

Soybean meal is used as a supplement in feed rations for livestock. Soybean meal is the world's 

most important protein feed, accounting for nearly 69% of world protein meal supplies 

(SoyStats, 2010e). Industrial uses of soybean range from a carbon/nitrogen source in the 

production of yeasts via fermentation to the manufacture of soaps, inks, paints, disinfectants, and 

biodiesel (see, e.g., Cahoon, 2003; SoyStats, 2010d). 

In the U.S., the majority of soybean is cultivated as a commodity crop for animal feed and 

soybean meal (Rogan, 2010). Recently, there has been an increase in the percentage of the crop 

dedicated to specialty soybean produced for a specific market or use. These specialty, valueadded products may be the whole bean or a fraction, such as the oil (Lee & Herbek, 2004). The 

production of specialty soybean is discussed in more detail in Subsection 2.2.4. 

2.1.2.2 Soybean Composition 

Generally, soybean seed consists of oil (about 20%), protein (about 40%), carbohydrate (about 

35%), and ash (about 5%) (USDA-APHIS, 2010b). 

Soybean Oil 

Soybean oil is used in a wide variety of food applications. Until 2005, soybean oil was the 

largest source of vegetable oil worldwide (USDA-ERS, 2010d). Since 2005, palm oil has 

overtaken soybean oil in volume of worldwide vegetable oil production (USDA-ERS, 2010d). 

Conventional soybean oil is composed of a mixture of fatty acids. Fatty acids are identified 
DRAFT MONSANTO 87705 SOYBEAN 

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based on the number of carbons and the degree to which they are saturated. Table 2-1 presents 

the fatty acid composition of soybean. 

Table 2-1: Fatty Acid Composition of Conventional Soybean Oil

Fatty Acid 

Lipid Number Common Name 

Percentage of Total Fatty Acid in 

Conventional Soybean Oil 

C6:0* Caproic Acid ND

C8:0 Caprylic Acid ND 

C10:0 Capric Acid (Decanoic) ND 

C12:0 Lauric Acid ND – 0.1 

C14:0 Myristic Acid (Tetradecanoic) ND – 0.2 

C16:0 Palmitic Acid 8.0 – 13.5 

C16:1 Palmitoleic Acid ND – 0.2 

C17:0 Margaric Acid (Heptadecanoic) ND – 0.1 

C17:1 Cis-10 Heptadecanoic Acid ND – 0.1 

C18:0 Stearic Acid 2.0 – 5.4 

C18:1 Oleic Acid 17 - 30 

C18:2 Linoleic Acid 48 – 59 

C18:3 Linolenic Acid 4.5 – 11 

C20:0 Arachidic Acid (Eicosanic) 0.1 – 0.6 

C20:1 Eicosenoic Acid ND – 0.5 

C20:2 Eicosadienoic Acid ND – 0.1 

C22:0 Behenic Acid (Docosanoic) ND – 0.7 

C22:1 Docosenoic Acid ND – 0.3 

C22:2 Docosenoic Acid ND 

C24:0 Lignoceric Acid (Tetracosanoic) ND – 0.5 

C24:1 Cis-tetracosenoic Acid ND 

*Fatty acids are identified based on the number of carbon atoms and the number of double bonds in that 

fatty acid. Hence, oleic acid is identified as C18:1, indicating that this fatty acid is comprised of 18 carbons 

with a single double bond. 

ND – Not detectable. 

Source: (CODEX, 2010) 

The five major fatty acids in conventional soybean oil are linoleic acid, oleic acid, palmitic acid, 

linolenic acid, and stearic acid (CODEX, 2010). Linoleic and linolenic are classified as 

polyunsaturated fatty acids, oleic acid is a monounsaturated fatty acid, and palmitic and stearic 

acids are saturated fatty acids (CODEX, 2010). 

The physical and chemical properties of conventional soybean oil limit its use for many food and 

industrial applications (Cahoon, 2003). As noted in Table 2-1, untreated soybean oil has high 

concentrations of the linolenic and linoleic acids, the two polyunsaturated fatty acids (US-FDA, 

1996). These polyunsaturated fatty acids are subject to oxidation, which affects flavor and 

product stability, and thus shortens its shelf life (US-FDA, 1996). To enhance stability, selective 

hydrogenation has been used to decrease the percentage of polyunsaturated fatty acids in the soy 

oil blend (US-FDA, 1996). The selective hydrogenation dramatically improves shelf life and 

provides stability during deep-frying and other high temperature applications (Mozzaffarian, 

Katan, Ascherio, Stampfer, & Willett, 2006). Although the hydrogenation process does increase 

the percentage of monounsaturated oleic acids, the hydrogenation process produces substantial 
DRAFT MONSANTO 87705 SOYBEAN 

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quantities of the trans isomer of oleic acid. Such trans fats have been identified as negatively 

impacting human cholesterol levels by raising the low-density lipoproteins (LDL) cholesterol 

and lowering the high-density lipoprotein (HDL) cholesterol. This association with trans-fatty 

acids has resulted in a decline in soybean oil consumption in the U.S. (USDA-ERS, 2006b). 

Soybean Meal 

Following solvent extraction of the oil, the remaining solid soybean flakes are toasted and 

ground to produce soybean meal (Soyatech, 2008). Soybean meal contains about 50% protein by 

dry weight (USDA-APHIS, 2010b). 

Only a small proportion (<5%) of the soybean meal is consumed directly by humans; 95% of 

domestic soybean meal is used by the American livestock industry (USDA-APHIS, 2010b). 

Soybean is considered to be a source of complete protein. A complete protein is one that 

contains significant amounts of all the essential amino acids that must be provided to the human 

body because of the body’s inability to synthesize them. The ten essential amino acids are 

arginine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, 

and valine (Kuiken & Lyman, 1949). Soybean provides these ten essential amino acids 

necessary for human nutrition (Kuiken & Lyman, 1949). The essential amino acid composition 

of soybean and soy-based products is provided in the USDA National Nutrient Database for 

Standard Reference (USDA-ARS, 2008b). 

Isoflavones 

Soybeans contain isoflavone compounds, polyphenol compounds closely related to the 

antioxidant flavonoids found in other plants (USDA-APHIS, 2010b). Soybean isoflavones are 

described as phytoestrogens because they exhibit estrogenic activity similar to estradiol 

hormones (Rostagno, 2009). These isoflavones may provide both positive and negative effects, 

as they are variously reported to exhibit estrogenic and anti-estrogenic effects, influence 

cardiovascular disease, impact cancer rates, and possibly slow the rates of osteoporosis. (See 

Higdon and Drake, 2009 for a summary of recent research on soy isoflavones.) 

Antinutrients 

Antinutrients are components of a food product which may be toxic at high concentrations, bind 

nutrients, or otherwise prevent their digestion. Soybeans contain several key antinutrients, such 

as oligosaccharides, lectins, phytic acid, and protease inhibitors (OECD, 2001). Lectins are 

sugar-binding proteins and can be rapidly degraded upon heating. The oligosaccharides (e.g., 

stachyose, raffinose) can cause flatulence when consumed (USDA-APHIS, 2010b). Phytic acid 

binds most of the phosphorus in soybean, preventing its absorption by an animal. It is common 

practice to add phytic acid-degrading enzymes to the animal feed formula (Rogan, 2010). 

Protease inhibitors interfere with the digestion of proteins, resulting in decreased animal growth 

(OECD, 2001). The antinutrients are destroyed during the heat treatment processing of the 

soybean products (OECD, 2001). 
DRAFT MONSANTO 87705 SOYBEAN 

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2.1.3 Cultivation of GE Soybeans 

Adoption of genetically engineered herbicide-tolerant (HT) soybeans increased from 17% of 

U.S. soybean acreage in 1997 to 68% in 2001 and 93% in 2010 (USDA-ERS, 2010a, 2010b). 

Use of herbicide-resistant crops is a major change in agriculture. Weed control had been one of 

the biggest challenges for soybean growers. Infestation with weeds during an entire growing 

season can result in soybean yield losses ranging from 12 to 80% (Barrentine, 1989; USDAAPHIS, 2010b). By the early 1990’s, there were over 70 individual herbicides or combination 

products registered for weed control in soybean (USDA-APHIS 2010b; see also Byrd, Blaine, & 

Poston, 2003). Along with the increased use of herbicides, biotypes of various plant species 

developed resistance to certain herbicide modes of action (Heap, 2011). 

With the 1996 commercial introduction of glyphosate-tolerant soybean, a major shift occurred 

with an increased use of glyphosate concurrent with the increased planting of glyphosate-tolerant 

soybean and a decrease in use of other soybean herbicides (USDA-APHIS, 2010b; USDA-ERS, 

2010a, 2010b). Other herbicide-tolerant soybeans are cultivated, including the LibertyLink®

soybean varieties (a GE variety resistant to glufosinate ammonium herbicide first introduced in 

1996) and STS (a conventionally bred sulfonylurea-tolerant soybean first introduced in 1993). 

Although these other varieties are available for selection by growers, the Roundup Ready®, 

glyphosate-tolerant varieties continue to dominate the market (see, e.g., Tarter, 2011). 

2.2 SOYBEAN PRODUCTION 

This section summarizes soybean production, seed production, organic farming, specialty 

soybean, general management practices (including identity preservation practices), management 

of weeds, insects and diseases, soybean rotational crops, and volunteer soybean management. 

2.2.1 Acreage and Areas of Soybean Production 

Soybean is grown as a commercial crop in over 35 countries (Rogan, 2010). Soybean is the most 

extensively grown oilseed in the world, with approximately 210 million metric tons (MMT) of 

harvested seed produced in 2009 (Soyatech, 2010). This represents 56% of world oilseed seed 

production for that year (Soyatech, 2010). 

In the U.S., soybeans are cultivated in 31 states, with over 77 million acres dedicated to soybean 

cultivation, projected to increase to nearly 80 million acres by 2020 (USDA-NASS, 2011a, 

2011b; USDA-OCE, 2011). Table 2-2 presents an overview of the 2009 and 2010 acreage of 

soybeans planted by state. 

 
DRAFT MONSANTO 87705 SOYBEAN 

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Table 2-2: Soybean Acreage by State, 2009 and 2010 

State 

Acres Planted 

(thousands) 

CY 2009 CY 2010 

Alabama 440 350 

Arkansas 3,420 3,190 

Delaware 185 175 

Florida 37 25 

Georgia 470 270 

Illinois 9,400 9,100 

Indiana 5,450 5,350 

Iowa 9,600 9,800 

Kansas 3,700 4,300 

Kentucky 1,430 1,400 

Louisiana 1,020 1,030 

Maryland 485 470 

Michigan 2,000 2,050 

Minnesota 7,200 7,400 

Mississippi 2,160 2,000 

Missouri 5,350 5,150 

Nebraska 4,800 5,150 

New Jersey 89 94 

New York 255 280 

North Carolina 1,800 1,580 

North Dakota 3,900 4,100 

Ohio 4,550 4,600 

Oklahoma 405 500 

Pennsylvania 450 500 

South Carolina 590 465 

South Dakota 4,250 4,200 

Tennessee 1,570 1,450 

Texas 215 205 

Virginia 580 560 

West Virginia 20 20 

Wisconsin 1,630 1,640 

Total Acreage 77,500 77,410 

Note: CY = Calendar Year 

Source: (USDA-NASS, 2011a, 2011b) 

Soybean yield varies by growing region and by variety cultivated. Soybean yields range from 26 

to 47 bushels per acre, with a trend towards higher yields in recent years (USDA-ERS, 2006b). 

The upward trend in yield is largely a result of new varieties that perform better under climate 

and pest pressures (USDA-ERS, 2006b). 

2.2.2 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 

(Hartman & Kester, 1975). Genetic purity in commercial seed production is generally regulated 
DRAFT MONSANTO 87705 SOYBEAN 

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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 (Hartman & Kester, 1975). 

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). 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 Foundation, Registered, and Certified seed. 

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

4) Certified (see, e.g., MCIA, 2009, 2010). Each class of seed is identified to designate the seed 

generation from the original breeder source (Hartman & Kester, 1975). The original seed 

Breeder seed stock is controlled by the developer of the variety (Adam, 2005; Hartman & Kester, 

1975). 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 & Kester, 1975). The Certified (or Select) seed is then 

sold to growers through commercial channels (Adam, 2005; Hartman & Kester, 1975). 

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

private seed certification programs (see, e.g., AOSCA 2010). Commercially certified soybean 

seed must meet state and Federal seed standards and labeling requirements. Standards for 

certified soybean seed are generally presented as follows (see, e.g., Certified Seed, 1988; 

Tennessee, 2009): 

 98% pure seed (minimum); 

 2% inert matter (maximum); 

 0.05% weed seed (maximum; not to exceed 10 per 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). 

State seed certification standards vary slightly from state to state and can be more restrictive than 

the seed standards of the Association of Official Seed Certifying Agencies (AOSCA). 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. 

Seed certification systems should be distinguished from identity preservation systems for certain 

agricultural commodities. Soybean Identity Preservation (IDP) refers to a system of production, 

handling, and marketing practices that maintains the integrity and purity of specialty crop 

products (Sundstrom, Williams, Van Deynze, & Bradford, 2002). Commodity grains are 

marketed in mass according to USDA grading standards. Specialty crops require some form of 

segregation or IDP to keep these grains separate from commodity grains (Elbehri, 2007). This 

segmentation helps preserve a specified purity of the product. With certain specialty crops (e.g., 
DRAFT MONSANTO 87705 SOYBEAN 

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organic or designated industrial-uses), IDP is required to prevent accidental or unintended 

commingling. 

Comments submitted in previous environmental assessments have identified issues pertaining to 

management practices designed to prevent accidental or unintended commingling of crops. 

Many of these practices are already well established in the soybean industry as part of the crop 

cultivation practices necessary to maintain IDP. 

The need for segregation and IDP production systems has increased with the development of 

specialty crops or crops with special output traits, such as high oil corn, high oleic sunflower, 

and low-linolenic soybean (Sundstrom, et al., 2002). MON 87705 Soybean is expected to be 

handled and marketed within the practices of the certified seed and IDP production systems, and 

is expected to meet all state and Federal seed standards and labeling requirements. 

2.2.3 Organic Farming 

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 (Rogan, 2010). 

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 §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 §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 
DRAFT MONSANTO 87705 SOYBEAN 

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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. In NOP 

organic systems, the use of synthetic pesticides or fertilizers, and GE crops, such as MON 

87705 Soybean, is strictly limited (USDA-AMS, 2010). 

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 (USDA-APHIS, 2010a). 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, 2010b). The current NOP regulations do not specify an acceptable 

threshold level for the adventitious presence of genetically engineered materials in an organiclabeled 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 & Fouche, 2006; USDA-AMS, 2010b). 

The production of organic soybeans represents between 0.17% and 0.22% of U.S. soybean 

production (USDA-ERS, 2010a). 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, 2010e). 

Organic soybean markets typically enjoy a market premium offsetting the additional production 

and record-keeping costs associated with this production method. 

2.2.4 Specialty Soybean Production 

The U.S. soybean IDP production and distribution systems accommodate differences between 

commodity and specialty soybean. Production systems designed prior to the introduction of 

MON 87705 Soybean or even prior to the introduction of biotechnology-derived soybean allow 

for production of specialty soybean varieties to meet varied customer demands. Although 

soybeans are primarily a commodity crop, there is an existing specialty soybean market. Distinct 

identity-preserved specialty soybean with such traits as clear hilum or high protein have been 

grown and successfully marketed for specific food uses in domestic and export markets for many 

years (Cui, James, Miyazaki, Wilson, & Carter, 2004). 

Specialty soybean varieties are specified by buyers and end-users of soybean for production, and 

premiums are paid for delivering a product that meets purity and quality standards for the 
DRAFT MONSANTO 87705 SOYBEAN 

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soybean variety. Product differentiation and market segmentation in the specialty soybean 

industry includes mechanisms to keep track of the soybean (traceability), methods for IDP, such 

as quality assurance processes (e.g., ISO 9001-2000 certification), as well as contracts between 

growers and buyers that specify delivery agreements. 

The distinction between the commodity soybean and the specialty soybean involves both 

certified seed production as well as IDP of the harvested crop. The majority of soybean in the 

U.S. is cultivated and marketed as a commodity for the oil and protein markets (Rogan, 2010). 

The goal of the commodity supply chain is to supply a homogenous product to the end user. 

Although the grower producing soybean for this chain may choose from many different varieties 

for cultivation, the harvested soybean is viewed to be the same for all commodity soybean 

varieties (Rogan, 2010). At harvest, the grower either delivers soybean to a handler or stores 

them on farm for later delivery. The commodity soybean is not differentiated for later use. 

Commodity soybean handlers typically have large volume storage capacity, and commodity 

soybean processors crush large volumes of soybean to produce homogeneous oil and meal 

products. The commodity system is designed to maximize efficiency at a low profit margin and 

results in comingling of different sources of soybean. The beneficial consequence of mixing 

soybean in the initial crush, increased homogeneity, is also one that does not affect the price 

received for the final product. This production system has been in place in the U.S. since the 

production of soybean began in earnest in the 1960s (Sonka, Bender, & Fisher, 2004). 

The specialty soybean market produces soybeans that have specific physical or chemical 

characteristics to meet specific buyer requirements. As a result of these special needs, a separate 

specialty soybean channel has developed for the specialty soybean product that involves much 

smaller volumes than commodity soybean (Smyth & Phillips, 2002; Sonka, et al., 2004). 

Specialty soybean varieties are produced on approximately 12% of the U.S. soybean acreage 

and, according to the Midwest Shippers Association (MSA, 2009), this acreage could grow to 

over 25% of the crop acreage in certain states within the next decade. This supply chain 

typically consists of a specialty firm that contracts production of a specific variety and sets 

standards for quality of the harvested soybean (Lee & Herbek, 2004). In return, growers receive 

a premium over the price paid for commodity soybean. Growers may store harvested soybean on 

farm or deliver the product directly to a processor or to special containers for international 

shipment. 

Specialty soybeans can be grouped into several broad categories (Rogan, 2010; UK, 2010): 

 non-biotechnology-derived; 

 certified seed; 

 organic food-grade; 

 low saturated fat; 

 clear hilum; 

 tofu; 

 natto; 

 high sucrose; 

 high oleic; 

 low linolenic and 
DRAFT MONSANTO 87705 SOYBEAN 

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 high protein. 

The categories refer to soybean with characteristics such as altered seed composition (e.g., low 

saturated fat, high sucrose, high oleic, low linolenic, and high protein), varieties of soybean with 

unique physical characteristics suited to their specific uses (e.g., clear hilum; i.e., small scar 

marking the seeds former place of attachment to the pod, for direct human consumption), or refer 

to a production process (e.g., organic, certified seed). The categories are not meant to be 

exclusive; for example, soybean used to produce natto or tofu may employ organic production 

processes. Moreover, soybeans of all specialty categories are often derived from varieties 

produced according to certified seed production practices. Tofu and soymilk produced from the 

tofu soybean category represent a large segment of the specialty soybean market and are 

produced from unique soybean varieties that have clear hilum and large seed size (Lee & 

Herbek, 2004). Tofu varieties also must be high in protein (40% or higher) and low in oil 

concentration compared with commodity soybean. Clear hilum and other characteristic are 

required for soybean used in the production of other soybean food products consumed directly by 

humans such as natto, soybean sprouts, edamame (vegetable soybean), and soy nuts (Lee & 

Herbek, 2004; UK, 2010). 

The majority of these specialty soybean varieties are offered in Maturity Group II and early 

Group III varieties which are adapted to the upper Midwest/Great Plains region (Lee & Herbek, 

2004). 

The IDP practices used in specialty soybean production require that all equipment and storage 

facilities for specialty soybean must be clean of seed from other soybean varieties or plants, dirt, 

pathogens, and other foreign material. Some soybean contracts may require a special inspection 

of the handling and storage facilities. The specialty soybean for soybean foods may require 

special harvesting equipment because some of these soybeans are harvested before full maturity 

(e.g., edemame or vegetable soybean). 

Weed control is extremely important for specialty soybean to maintain a high yield potential. 

Weeds, such as nightshade (Solanum nigrum), can stain harvested soybean, which is particularly 

undesirable in food-grade soybean (TCM, 2008). 

2.2.5 Soybean Cultivation Practices 

Soybean self-pollinates and is propagated by seed (OECD, 2000). Proper seedbed preparation, 

appropriate variety selection, appropriate planting dates and plant population, and good 

integrated pest management practices are important for optimizing the yield potential and 

economic returns of soybean (USDA-APHIS, 2010b). 

Soybean varieties are developed and adapted to certain geographical zones and are separated into 

ten maturity groups – Group 00 to Group VIII: Group 00 through Group IV soybean varieties 

are planted in the Midwest and Eastern Coastal regions; Groups IV through VIII are planted in 

the southern states (Helsel & Minor, 1993; Hodges & French, 1985). 
DRAFT MONSANTO 87705 SOYBEAN 

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2.2.5.1 Pre-Season Preparation 

Crop rotation, tillage system, row spacing, planting equipment, seed or variety selection(s), and 

soil fertility require production decisions well in advance of planting the soybean crop. Because 

of the many benefits associated with crop rotation, the majority of the soybean acreage is planted 

in a two-year corn-soybean rotation. The crop rotation sequence can be modified to take 

advantage of a particular economic or market opportunity. 

2.2.5.2 Planting and Early Season 

Adequate soil moisture and warm temperatures facilitate rapid seed germination and emergence. 

Planting date has the greatest impact on yield (Hoeft, Nafziger, Johnson, & Aldrich, 2000). 

Soybean can germinate at a soil temperature of 50oF when planted at a depth of two inches, with 

the ideal soil temperature for soybean germination and emergence at 77oF (Pedersen, 2010; 

Pedersen & Lauer, 2004). However, waiting for soils to reach this soil temperature will delay 

planting beyond the optimum planting date that will maximize yield. 

Highest yields are generally obtained when planting is done in early to mid-May. Yields begin 

to drop off quite rapidly when planting is delayed until late May. For example, the optimum 

planting dates for soybean in Iowa are the last week of April in the southern two-thirds of the 

state and the first week of May in the northern one-third of the state (Pedersen & Lauer, 2004). 

In the southern U.S., yields of adapted varieties are highest when soybean is sown in May or 

early June. Planting before late April results in shorter plants and, in many cases, lower yields. 

Planting after early June generally decreases plant height and yield due to water shortages in July 

and August. 

2.2.5.3 Mid- to Late Season 

Ideal daytime temperatures for soybean growth are between 75oF and 85oF (Hoeft, et al., 2000). 

Warmer temperatures result in larger plants and earlier flowering. Sustained temperatures below 

75oF will delay the beginning of flowering significantly. Seed set also is affected by 

temperature. Seed set is generally ideal when pollination follows night temperatures around 

70oF. Soybean varieties differ in their response and tolerance to temperatures. 

The first appearance of flowers signals the beginning of the reproductive stage (Hoeft, et al., 

2000). The reproductive period consists of flowering, pod set, and seed formation. Climatic 

conditions such as temperature and moisture supply during the flowering period will affect the 

number of flowers. The soybean plant does not form a pod for each flower. It is common for a 

soybean plant to have 75% of its flowers fail to develop a pod (Rogan, 2010; Scott & Aldrich, 

1970). 

2.2.5.4 Harvest Season 

At maturity, the seed moisture content is approximately 55 to 60%. At this stage, at least one 

pod on the plant reaches maturity (Hoeft, et al., 2000). Under warm and dry weather conditions, 

seed moisture content will drop to 13 to 14% in 10 to 14 days from physiological maturity 

(Hoeft, et al., 2000). Soybean is harvested when the moisture content drops below 15%. 
DRAFT MONSANTO 87705 SOYBEAN 

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2.2.5.5 Soybean Crop Rotation and Control of Volunteers

Soybean crop rotation is an important management practice to manage weeds, to control 

volunteer soybeans, and to limit the potential for weeds to develop resistance to herbicides (e.g., 

glyphosate-resistant pigweed). According to USDA Economic Research Service, 95% of the 

soybean-planted acreage has been in some form of a crop rotation system since 1991 (USDAERS, 2010c). 

The benefits of soybean rotation with, for example, corn are many and include: 

 Improved yield and profitability of one or both crops; 

 Decreased need for additional nitrogen on the crop following soybean; 

 Increased residue cover; 

 Mitigation or disruption of disease, insect, and weed cycles; 

 Reduced soil erosion; 

 Increased soil organic matter; 

 Improved soil tilth and soil physical properties; and 

 Reduced runoff of nutrients, herbicides, and insecticides (Al-Kaisi, Hanna, & Tidman, 

2003). 

Agronomic practices for soybean rotations vary from state to state. Continuous (i.e., nonrotation) soybean production is discouraged by most extension soybean specialists to reduce the 

risk of diseases and nematodes (Al-Kaisi, et al., 2003). The majority of the U.S. soybean acreage 

(68.6%) is rotated to corn (see Rogan, 2010 at page 157, et seq.). Approximately 14.5% of the 

soybean acreage is rotated back to soybean the following year. Wheat follows soybean on 

approximately 11.2% of the U.S. soybean acreage, with cotton, rice, and sorghum the next 

largest rotational crops following soybean (4.6% of the soybean acreage). Other minor rotational 

crops that follow soybean production include barley, rice, oats, and dry beans. 

In previous APHIS assessments, volunteer crop plants have been identified as an area of concern 

in the review of herbicide-tolerant plantings. Volunteer plants are considered weeds, as they 

compete with the subsequent crop for water, nutrients, and space. An analysis of the weediness 

potential of herbicide-tolerant soybean can be based upon an analysis of volunteer soybeans. 

Volunteer soybean is defined as a plant that has germinated and emerged unintentionally in 

a subsequent crop. Soybean seeds can remain in a field after soybean harvest as a result of 

pods splitting before or during harvest. Soybean seeds also can remain in a field when pod 

placement on the plants is too close to the ground for the combine head to collect all the 

pods or when the combine is improperly adjusted for efficient harvesting. 

Volunteer soybean, whether a GE variety specifically engineered to present herbicide tolerance 

or a conventional non-GE variety, are not considered a significant concern in rotational crops 

primarily because of climatic conditions and adequate control from mechanical and chemical 

methods available to manage the occasional volunteer soybean plant. 

Volunteer soybean seed is typically not viable after the winter period in the North. In 

soybean growing areas in the southern U.S., where soybean seed may remain viable over the 
DRAFT MONSANTO 87705 SOYBEAN 

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winter and germinate the following spring, mechanical and chemical controls are used 

(Carpenter et al., 2002; OECD, 2000). Pre-plant tillage is the first management tool for control 

of emerging volunteer soybean in the spring. If volunteer soybean plants emerge after planting, 

shallow cultivation will control most of the plants and effectively reduce competition with the 

crop. 

Several post-emergence herbicides also are available to control volunteer soybean (conventional 

or glyphosate-tolerant soybean) in each of the major rotational crops. Control of volunteer 

soybean in corn can be provided by post-emergence applications of AAtrex (atrazine), Clarity 

(dicamba), Distinct (diflufenzopyr + dicamba), Hornet (flumetsulam + clopyralid), and 

Widematch (clopyralid + fluroxypyr). In wheat, Bronate Advanced (bromoxynil), Clarity, and 

Widematch post-emergence provide control of volunteer soybean (Zollinger, 2010). 

Volunteer soybean in cotton is normally not a concern. However, extreme weather 

conditions, such as hurricanes, may damage a soybean crop preceding cotton production in 

the Mid-South states, where the unharvested soybean seed can produce volunteer plants. 

Pre-plant applications of paraquat or herbicide mixtures containing paraquat will effectively 

control volunteer glyphosate-tolerant soybean (Montgomery, Hayes, Tingle, & Kendig, 

2002; Murdock, Jones, & Graham, 2002). Recent research in North Carolina indicates that 

Envoke (trifloxysulfuron) provides excellent post-emergence control of soybean containing 

traits for glyphosate and sulfonylurea herbicide tolerance in Roundup Ready® cotton (York, 

Beam, & Culpepper, 2005). 

Volunteer soybean in rice is rarely a concern due to the combination of pre-plant tillage, 

flooding practices, and herbicides used in producing rice. If volunteer plants should emerge 

in rice, the post-emergence applications of Grasp (penoxsulam), Permit (halosulfuron), and 

Regiment (bispyribac), typically used for weed control in rice, effectively alleviate 

competition from volunteer soybean (Dillon, Scott, Pearrow, & Meins, 2006). 

2.3 PHYSICAL ENVIRONMENT 

The use of fertilizers, pesticides, and water may affect segments of the environment including, 

but not limited to: waterways by increases in nutrient pollution; biodiversity resulting from 

adverse effects of pesticide use; the water table resulting from excessive irrigation practices; and 

field productivity because irrigation may increase salinity (Hoeft, et al., 2000). Increased soil 

runoff and consequent siltation, elevated nutrients, pesticides, increased salinity, and pathogens 

are primary agricultural pollutants (USDA-ERS, 2005). This subsection provides an overview of 

the current physical environment in which soybean is cultivated. 

2.3.1 Soil and Land Use 

Soybean is grown as a commercial crop on over 75 million acres in at least 31 states in the U.S. 

(USDA-NASS, 2010a). Soybean acreage in the past five years has been relatively stable varying 

from 64.7 million to 78.9 million acres with a 10-year average of 73.3 million acres (USDANASS, 2010a). Fluctuations in soybean acreage are due to environmental, agronomic, and 

economic factors, as well as government programs such as the crop reserve program (CRP) or 
DRAFT MONSANTO 87705 SOYBEAN 

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ethanol mandates imposed by the U.S. government which drive acreage into source crops for 

ethanol. 

Soybean fields are typically highly managed agricultural areas that are dedicated to crop 

production for many years. The production of soybean is highly dependent upon soil and 

climatic conditions. Soybean is cultivated in a wide variety of soils, but does not do well in acid 

soils (OECD, 2000). In the U.S., the soil and climatic requirements for growing soybean are 

very similar to corn, and thus, the two crops share a similar cultivation area (Rogan, 2010). 

The practice of tillage for soil preparation and weed management can affect the quality of soils 

because of the varying impacts of erosion on soil nutrient composition. Field preparation is 

accomplished through a variety of tillage systems, with each system defined by the remaining 

plant residue on the field (US-EPA, 2010). Conventional tillage is associated with intensive 

plowing and less than 15% crop residue at the soil surface; reduced tillage is associated with 15 

to 30% crop residue; and conservation tillage, including no-till practices, is associated with at 

least 30% crop residue and substantially less soil erosion than other tillage practices (US-EPA, 

2010). As conservation practices are adopted, there are increases in soil organic matter that helps 

bind soil nutrients and significantly reduces the loss of cropland soil from runoff, erosion, and 

leaching over time (Leep, Undersander, Min, Harrigan, & Grigar, 2003; USDA-NRCS, 2006b, 

2006c). Total soil loss on highly erodible croplands and non-highly erodible croplands 

decreased from 462 million tons per year to 281 million tons per year or by 39.2% from 1982 to 

2003 (USDA-NRCS, 2006c). This decrease in soil erosion accompanies a corresponding 

decrease in non-point source pollution of surface water by fertilizer and pesticides (USDANRCS, 2006c). The reduction in soil erosion is also attributed to a decrease in the number of 

acres of highly erodible cropland being cultivated (USDA-NRCS, 2006c). Soil tillage can also 

affect water resources and air quality, which is discussed in Subsections 2.3.2 and 2.3.3, 

respectively. 

Several authors suggest a relationship between the introduction of herbicide-tolerant soybean 

varieties and an increase in the practice of no-till or conservation tillage by U.S. growers. In 

1995, before the introduction of glyphosate-tolerant soybeans, approximately 27% of the U.S. 

soybean acres used no-till production, but by 2004, no-till acres increased to 36% of the total 

soybean acres (Sankula, 2006). In 2008, approximately 43 million acres (62%) of soybean were 

planted in a no-till system (Towery & Werblow, 2010). 

A few states provide statistics on the adoption of no-till acres in their state. In 2006 in Illinois, 

no-till farming was used on 51% of the soybean acres (Rogan, 2010). The University of Illinois 

Extension Service attributed that figure to the fact that 90% of the state’s acres were planted to 

glyphosate-tolerant varieties, along with other factors, such as high fuel prices, improved 

equipment, higher yields using no-till practices, and better grower awareness of the advantages 

to soil and water quality from no-till farming (University of Illinois, 2006). 

A legume, the soybean plant fixes a significant portion of its own nitrogen through the symbiotic 

relationship with the nitrogen-fixing Bradyrhizobia bacteria (Bradyrhizobium japonicum) that 

live in soybean root nodules (Hoeft, et al., 2000). The soybean root nodules contain colonies of 

bacteria which take gaseous nitrogen from the atmosphere and fix it in forms easily used by the 

soybean plant. Because the nitrogen-fixing bacteria are not native to U.S. soils and would not 
DRAFT MONSANTO 87705 SOYBEAN 

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normally be found in these soils, soybeans are frequently inoculated with these bacteria prior to 

planting, especially if soybean has not been grown in a field for three to five years (Pedersen, 

2007). 

2.3.2 Water Resources 

The soils and climate in the Eastern, Midwestern, and portions of the Great Plains region of the 

U.S. provide sufficient water supplies under normal climatic conditions to produce a soybean 

crop. The general water requirement for a high-yielding soybean crop is approximately 20 

inches of water during the growing season (Hoeft, et al., 2000). In 2008, over 56% of the 

soybean crop in the U.S. was irrigated (USDA-NASS, 2010b). Soil texture and structure are key 

components determining water availability in soils which, in turn, affects soybean root depth and 

density. As medium-textured soils are able to hold more available water, the soybean roots in 

medium textured soils are more dense and extend to a typical depth of 1.2 m. By contrast, soils 

that are more compact (e.g., clayey soils) hold less water and, as a result, the soybean plant root 

mass is less dense and shallower. 

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 consequent 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). 

2.3.3 Air Quality and Climate Change 

Agricultural air emission sources include: smoke from agricultural burning; vehicle exhaust 

associated with equipment used in tillage and harvest; soil particulates associated with tillage; 

pesticide drift from spraying; and nitrous oxide emissions from the use of nitrogen fertilizer 

(Aneja, Schlesinger, & Erisman, 2009; Hoeft, et al., 2000; US-EPA, 2010; USDA-NRCS, 

2006a). These agricultural activities individually have the potential to cause negative impacts to 

air quality. 

Aerial application of pesticides may cause air quality impacts from drift and diffusion. 

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

constituents of entrained materials in wind eroded soils (Vogel, Majewski, & Capel, 2008). 

Agriculture, including land-use changes for farming, is responsible for an estimated 6% of all 

human-induced greenhouse gas (GHG) emissions in the U.S. (US-EPA, 2010). It is important to 

note that livestock were responsible for the largest fraction of methane emissions (80% of total 

methane via enteric fermentation and manure management) (US-EPA, 2010). Emissions of 

GHG released from agricultural equipment (e.g., irrigation pumps and tractors) include carbon 

monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (USEPA, 2010). Agricultural soil management practices, including nitrogen-based fertilizer 

application and cropping practices, are the largest source of U.S. N2O emissions. Croplands 

account for 69% of the total nitrous oxide (N2O) emissions attributable to agricultural land uses 

(US-EPA, 2010). Agriculture sources of methane (CH4) emissions are primarily associated with 

enteric emissions of gas from cattle and manure management. Carbon dioxide (CO2) is also a 
DRAFT MONSANTO 87705 SOYBEAN 

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significant GHG gas associated with several agricultural practices, including classes of crops, 

location and soil types associated with the practices, and energy consumption (Cole et al., 1997; 

US-EPA, 2010). 

Tillage contributes to the release of GHG because of the loss of CO2 to the atmosphere, and the 

exposure and oxidation of soil organic matter (Baker, Southard, & Mitchell, 2005). Herbicidetolerant crops may encourage dramatic increases in the adoption of conservation tillage programs 

whose consequences may include reductions of many of these emission concerns. 

GHG may be indirectly affected by the class of crop planted and soil types; trees, grasses and 

field crops each play a slightly different role in the global cycle of GHG (Cole, et al., 1997; 

Freibauer, Rounsevell, Smith, & Verhagen, 2004; US-EPA, 2010). For example, emissions of 

nitrous oxide, produced naturally in soils through microbial nitrification and denitrification, can 

be dramatically influenced by fertilization, introduction of grazing animals, cultivation of 

nitrogen-fixing crops and forage, retention of crop residues (i.e., no-till conservation), irrigation, 

and fallowing of land (US-EPA, 2010). These same agricultural practices can influence the 

decomposition of carbon-containing organic matter sequestered in soil, resulting in conversion to 

carbon dioxide loss to the atmosphere (US-EPA, 2010). Conversion of crop land to pasture 

results in an increase in carbon and nitrogen sequestration in soils (US-EPA, 2010). 

The EPA has also identified regional differences in GHG emissions associated with agricultural 

practices on different soil types, with high mineral content soils responding to GHG differently 

than high-organic content soils (US-EPA, 2010). Mineral soils contain from 1 to 6% organic 

carbon by weight; conversion of such soils from their native state to agricultural uses can cause 

as much as 50% of the natural organic carbon to decompose and be released to the atmosphere 

(US-EPA, 2010). In contrast, organic soils may contain as much as 20% carbon by weight (USEPA, 2010). When such organic soils are prepared for agricultural use, the soils are aerated, 

accelerating decomposition and release of CO2 to the atmosphere (US-EPA, 2010). 

Climate change may impact agriculture. In response to climate change, the current range of 

weeds and pests of agriculture is expected to change. In response to these new ranges, current 

agricultural practices may be required to change (IPCC, 2007). Climate change may potentially 

provide a positive impact to agriculture. The IPCC predicts that potential climate change in 

North America may result in an increase in crop yield by 5-20% for this century (IPCC, 2007). 

However, this positive impact will not be observed across all growing regions. The IPCC report 

notes that certain regions of the U.S. will be negatively impacted because available water 

resources may be substantially reduced. Note that the extent of climate change effects on 

agriculture is highly speculative. Nevertheless, North American production is expected to adapt 

to climate change impacts with improved cultivars and responsive farm management (IPCC, 

2007). 

2.4 BIOLOGICAL RESOURCES 

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

transfer, weeds and weediness, plants, microorganisms, animals, 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. 
DRAFT MONSANTO 87705 SOYBEAN 

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2.4.1 Gene Movement and Weediness 

Gene flow has been defined as the “incorporation of genes into the gene pool of one population 

from one or more populations” (Stewart, 2008; USDA-APHIS, 2010c). Gene flow is a basic 

biological process in plant evolution and in plant breeding. Gene flow, itself, does not pose a 

plant pest risk (USDA-APHIS, 2010c); it does so when specific genes with plant pest potential 

are incorporated into a cultivated plant. There are two types of gene flow: horizontal and 

vertical. Horizontal gene flow is the movement of genes between disparate, unrelated species, 

such as between plants and microbes or between plants from different families (Stewart, 2008). 

There is no evidence that horizontal gene transfer can naturally occur between unrelated plant 

species (see, e.g., Stewart, 2008; Twyman, 2003). 

In plant biology, when gene flow occurs between individuals from genetically distinct 

populations of the same species and a new plant is formed, this is called vertical gene flow and 

the new plant is called a hybrid (Stewart, 2008; USDA-APHIS, 2010c). Hybridization is usually 

thought of as the breeding of closely related species resulting in the creation of a plant that has 

characteristics different from either parent. When plants are moved to a new environment (with 

or without human intervention), they may hybridize with plants of a closely related species or 

subspecies in that new location. For natural hybridization to occur between two distinct but 

related populations, the plants from the two populations must flower at the same time, they must 

be close enough so that the pollen can be carried from the male parent to the female parent, 

fertilization must occur, and the resulting embryo must be able to develop into a viable seed that 

can germinate and form a new plant (Ellstrand, 2003; USDA-APHIS, 2010c). 

Hybridization may occur in one generation, but in most cases, does not progress on its own 

through subsequent generations. If it does, and stable new populations result, the process is 

called introgression. For introgression to occur, hybridization of offspring with the parental 

types (backcrossing) must occur several times. Because hybrids of distantly related species may 

not produce viable seed, introgression is much less common than hybridization. For example, in 

studies done with canola and a weedy relative, backcrossing from the hybrids to the weeds 

occurred at one-hundredth to one-thousandth the rate of the original hybridization (Stewart, 

2008). Nevertheless, when weed species are introduced to new areas, there is the potential that 

those introduced plants may hybridize with other closely related species. Novel hybrids 

therefore may be created. In addition, novel hybrids may be created through back-crossing (i.e., 

introgression) with parent species which may change the native species by incorporating nonnative genetic material. Invasive weeds can result from hybridization events, which mix genetic 

material potentially producing a wide array of genotypes. Some of these genotypes may exhibit 

increased invasive properties (USDA-APHIS, 2010c; USDA-ARS, 2008a). 

Characteristics that favor natural hybridization between two populations include (Mallory-Smith 

& Zapiola, 2008; USDA-APHIS, 2010c): 

 Presence of feral populations (domestic populations gone wild) and uncontrolled 

volunteers; 

 Presence of a high number of highly compatible relatives; 

 Self-incompatibility; 

 Large pollen source; 
DRAFT MONSANTO 87705 SOYBEAN 

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 Large amounts of pollen produced; 

 Lightweight pollen; 

 Strong winds (wind pollinated); 

 Large insect populations (insect pollinated); and 

 Long pollen viability. 

There are certainly others – the creation of a hybrid depends on a series of events including: 

 There must be a conduit for the parent gene of one plant species to enter the population of 

the species to be hybridized – requires the parent plant gene and the receptor plant to 

produce fertile offspring and 

 The hybridization must confer a fitness advantage that allows the gene, over multiple 

generations, to develop into a sustainable, reproducing population. 

Soybean is not native to the U.S. and there are no feral or weedy relatives. Soybean is a selfpollinated species, propagated by seed (OECD, 2000). The papilionaceous flower consists of a 

tubular calyx of five sepals, a corolla of five petals, one pistil, and nine fused stamens with a 

single separate posterior stamen. The stamens form a ring at the base of the stigma and elongate 

one day before pollination, at which time the elevated anthers form a ring around the stigma 

(OECD, 2000). 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. The anthers mature in the bud and directly pollinate the stigma of the 

same flower. 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 very low frequency (0 

to 6.3%) in adjacent plants (Caviness, 1966; Ray, Kilen, Abel, & Paris, 2003; USDA-APHIS, 

2010a; Yoshimura, Matsuo, & Yasuda, 2006). Pollination typically takes place on the day the 

flower opens. The pollen naturally comes in contact with the stigma during the process of 

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. 

Horizontal gene transfer and expression of DNA from MON 87705 Soybean to soil bacteria are 

unlikely to occur for several reasons (USDA-APHIS, 2010a). First, many genomes (or parts 

thereof) have been sequenced from bacteria that are closely associated with plants including 

Agrobacterium and Rhizobium (Kaneko et al., 2000; Kaneko et al., 2002; Wood et al., 2001). 

There is no evidence that these bacteria contain genes derived from plants. Second, in cases 

where review of sequence data suggest that horizontal gene transfer might have occurred, these 

events are expected to have occurred on an evolutionary time scale, i.e., on the order of millions 

of years (Brown, 2003; Koonin, Makarova, & Aravind, 2001; USDA-APHIS, 2010b). Third, 

transgene DNA promoters and coding sequences are optimized for plant expression, not 

prokaryotic bacterial expression. Thus, even if horizontal gene transfer were to occur, proteins 

corresponding to the transgenes are not likely to be produced. Fourth, the FDA has evaluated 

horizontal gene transfer from the use of antibiotic resistance marker genes, and concluded that 

the likelihood of transfer of antibiotic resistance genes from plant genomes to microorganisms in 
DRAFT MONSANTO 87705 SOYBEAN 

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the gastrointestinal tract of humans or animals (e.g., E. coli), or in the environment, is remote 

(US-FDA, 1998). 

2.4.2 Animals 

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

may seasonally consume soybean and invertebrates can feed on the plant during the entire 

growing season. Animals that feed primarily on soybean are seed-feeding insects and rodents 

found in agricultural fields. Rodents, such as mice or squirrels, may seasonally feed exclusively 

on soybean seeds. Thus, these animals may have a diet containing significant amounts of 

soybean seeds. Deer may also browse in soybean fields on the forage and on seed left after 

harvest. 

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 & Pike, 

1998; Higley & Boethel, 1994). Insect injury in soybean seldom reaches levels that cause 

significant economic loss, as indicated by the low percentage (14%) of soybean acreage that 

receives an insecticide treatment (USDA-NASS, 2006). 

2.4.3 Plants 

The development and management of herbicide tolerance or resistance in weed species has been 

raised as a concern. This section briefly presents a summary of the weedy non-crop plants 

commonly associated with soybean cultivation, the development of herbicide resistance in these 

weeds, and the mechanisms for control of such weeds. 

Soybean production systems in agriculture (i.e., the combination of management practices) are 

host to many plant species. The environment surrounding a soybean field varies in plant 

composition depending on the region. In certain areas, soybean fields may be bordered by other 

soybean varieties, corn, or other crops. In addition, fields may also be surrounded by woodlands 

and/or pasture/grassland areas, as well as aquatic environments. Therefore, the types of 

vegetation, including the variety of weeds, adjacent a soybean field depend on the area where the 

soybean is planted. 

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

by perennial weeds (Aref & 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). The primary factors affecting soybean yield loss 

from weed competition are the weed species, weed density, and the duration of the 

competition. When weeds are left to compete with soybean for the entire growing season, 

yield losses can exceed 75% (Dalley, Renner, & Kells, 2001). 

Generally, the effects of competition increase with increasing weed density (Rogan, 2010). 

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 
DRAFT MONSANTO 87705 SOYBEAN 

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withstand early-season weed competition longer than corn as the soybean canopy closes 

earlier in soybean than in corn (Mallory-Smith & Zapiola, 2008; Rogan, 2010). The extent 

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

below the soybean. In addition, canopy closure occurs much sooner when soybean is drilled 

or planted in narrow rows. 

The petitioner identifies 86 common weeds of soybean across three growing regions (Rogan 

2010, at pages 150-151). Crop rotations and environment have a significant impact on the 

adaptation and occurrence of weeds in soybean. Foxtail spp., pigweed, velvetleaf (Abutilon 

theophrasti), lambs quarters (Chenopodium album), and cocklebur (Xanthium strumarium) 

are common annual weeds in Midwest corn and soybean fields. However, growers consider 

giant ragweed (Ambrosia artemisiifolia), lambs quarters, Canada thistle (Cirsium arvense), 

cocklebur, and velvetleaf to be the top five most problematic weeds in corn and soybean 

because of the difficulty to control these weeds (Nice & Johnson, 2005). The most 

frequently reported common weeds in the Southeast region are morning glory (Ipomoea 

spp.), prickly sida (Sida spinosa), johnsongrass (Sorghum halepense), sicklepod (Cassia 

obtusifolia), and broadleaf signalgrass (Brachiaria platyphylla) (Webster, 2005). 

Cultural and mechanical weed control practices are important components of an effective weed 

management program (Loux, et al., 2008). Crop rotation, narrow row spacing, and planting date 

are a few of the crop management practices that are implemented to provide the crop with a 

competitive edge over weeds (Rogan, 2010). Although the primary purpose of tillage is for 

seedbed preparation, tillage is still used to supplement weed control with selective herbicides in 

soybean production. 

Herbicides provide effective and economical control of weeds in soybean. Approximately 98% 

of the soybean acreage received an herbicide application in 2006 indicating the importance of 

weed control in maximizing soybean yield (USDA-ERS, 2010b). Herbicide-tolerant soybean 

was introduced to provide growers with additional options to improve crop safety and/or 

improve weed control. The Roundup Ready® soybean system, i.e., planting Roundup Ready®

soybean and applying glyphosate in crop, has become the standard weed control program in U.S. 

soybean production and is planted on 93% of the soybean acreage (USDA-NASS, 2010a). 

Herbicide resistance, and the mechanism with which such resistance emerges in weeds, has 

been raised previously as a concern with herbicide-tolerant crop varieties. Although some 

have attributed weed resistance development to gene flow from an engineered crop to an 

unrelated species, this situation has never been demonstrated (Stewart, 2008). The 

emergence of herbicide resistance in weeds is a function of natural selection. With any 

herbicide use, the potential exists for the selection of weeds resistant to that herbicide. 

Within a weed species, individuals may possess an inherent ability to resist the effects of a 

particular herbicide. Repeated use of that herbicide will expose the weed population to a 

"selection pressure," which may lead to an increase in the number of surviving resistant 

individuals in the population (HRAC, 2009). In other words, plants susceptible to the 

applied herbicide will die; whereas, those few having some type of natural resistance will 

survive and reproduce. 
DRAFT MONSANTO 87705 SOYBEAN 

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Weed resistance is generally defined by the Weed Science Society of America (website at 

www.wssa.net) as: (1) the ability to survive application rates of an herbicide product that 

once were effective in controlling it; and (2) resistance is heritable. Herbicide-resistant 

weeds are neither a new phenomenon nor is resistance unique to the use of glyphosate. 

Growers have been managing herbicide-resistant weeds for decades with the use of 

alternative herbicides and/or cultural methods such as tillage or crop rotation. 

The occurrence of an herbicide-resistant weed biotype generally does not end the useful 

lifespan or preclude the effective use of the herbicide in question as part of an overall weed 

management system. This is particularly true for glyphosate due to the wide spectrum of 

weeds it effectively controls and its ability to control a weed at different growth stages, 

despite its lack of effectiveness on some specific resistant weed biotypes. 

A list of glyphosate-resistant weeds that occur in the U.S. is provided below in Table 2-3. 

Table 2-3: U.S. Glyphosate-Resistant Weeds through March 2011 

Weeds identified outside of Roundup Ready®

Systems 

Rigid ryegrass (Lolium rigidum) 

Hairy fleabane (Conyza bonariensis) 

Weeds identified in Roundup Ready® Systems Annual bluegreass (Poa annua)

 Kochia (Kochia scoparia) 

 Common ragweed (Ambrosia artemisiifolia) 

 Giant ragweed (Ambrosia trifida) 

 Horseweed, marestail (Conyza canadensis) 

 Palmer amaranth (Amaranthus palmeri) 

 Common waterhemp (Amaranthus rudis) 

 Italian ryegrass (Lolium multiflorum) 

 Johnson grass (Sorghum halepense) 

Source: (Heap, 2011; Rogan, 2010) 

To date, fifteen weed species resistant to glyphosate have been identified and confirmed 

worldwide. Nine species resistant to glyphosate have been confirmed in the U.S., two of 

which were identified outside of Roundup Ready® cropping systems. The speed of the 

spread in geographical distribution of the resistant species has varied. The reproductive 

biology of the particular weed species appears to be a factor contributing to the spread of 

resistant biotypes. Marestail (Conyza canadensis), which produces a large number of wind 

dispersed seeds contributing to a rapid distribution, has been found in many states in the 

northeast, midwest and the south. Some species such as common ragweed (Ambrosia 

artemisfolia) produce seeds that do not have features that allow for such easy distribution by 

the wind. As a consequence, biotypes of resistant ragweed have been found in a limited 

number of sites across the Midwest (Lingenfelter, 2007). 

One of the major factors contributing to the development of resistant weeds is poor weed 

control management practices. These include application of herbicides at rates below those 

indicated on the EPA-approved label for the weed species and sole reliance on a single 

herbicide for weed control without the use of other herbicides or cultural control methods 

(i.e., pre-plant and in-crop tillage) (Beckie, 2006; Peterson et al., 2007). 
DRAFT MONSANTO 87705 SOYBEAN 

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The EPA administers the Federal laws governing pesticide sale and use (FIFRA). EPA 

encourages pesticide manufacturers to provide growers with information regarding an 

herbicide’s mode of action to aid growers in planning herbicide use practices and to foster 

the adoption of effective weed-resistance management practices as specified by EPA in PR 

Notice 2001-5 (US-EPA, 2001). In that document, EPA states that “this approach to 

resistance management is sound and would be highly beneficial to pesticide manufacturers 

and pesticide users” (US-EPA, 2001). EPA approves all pesticide label use instructions 

based on the Agency’s evaluation of supporting data supplied by the pesticide registrant or 

manufacturer. After EPA approves a pesticide label, it is a violation of Federal law to use 

the pesticide for a use or in a manner not in accordance with the label directions. 

Monsanto incorporates EPA’s guidelines for pesticide resistance management labeling on its 

glyphosate-based agricultural herbicide labels. (An example of current Roundup 

WeatherMAX® product label is available at (http://www.cdms.net/ldat/ld5UJ055.pdf). EPAapproved labels for Roundup® branded herbicide weed-resistant management 

recommendations are designed to minimize the potential for the development of glyphosateresistant weeds. 

The risk of weeds developing resistance to herbicides and the potential impact of resistance on 

the usefulness of an herbicide vary greatly across different mechanisms of action and depend on 

a combination of factors including selection pressure, herbicide soil residual activity, herbicide 

chemistry, and the rate of seed production, and the level of genetic variation in plants. Weedresistance management programs that integrate the use of herbicides with different mechanisms 

of action and short residual activity times in soil reduce selection pressure (Prather, Ditomaso, & 

Holt, 2000). In conjunction with crop rotation, which may allow the grower to manipulate 

planting times to avoid early-season weed germination (Jordan, Mortensen, Prenzlow, & Cox, 

1995) and to use mechanical as well as chemical weed control methods, these practices impede 

the development of herbicide resistance in weeds. 

2.4.4 Microorganisms 

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

toxin removal, nutrient cycling, and most biochemical soil (Garbeva, van Veen, & van Elsas, 

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

Sarrantonio, & Liebig, 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). 

Members of the bacterial family Rhizobiaceae and Bradyrhizobiaceae form a highly complex 

and specific symbiotic relationship with leguminous plants, including soybean (Gage, 2004). 

The nitrogen-fixing plant-microbe symbiosis results in the formation of root nodules, providing 

an environment in which differentiated bacteria called bacteroids are capable of reducing or 
DRAFT MONSANTO 87705 SOYBEAN 

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fixing atmospheric nitrogen. The product of nitrogen fixation, ammonia, then can be utilized by 

the plant. In soybean, atmospheric nitrogen is fixed into ammonia through a symbiotic 

association with the bacterium Bradyrhizobium japonicum. As a result of this relationship, no 

nitrogen enhancement of soils is needed for agricultural production of soybean thereby reducing 

the need to fertilize the fields. 

Changes in the fatty acid composition of the soybean have the potential to impact the symbiotic 

relationship with Rhizobiaceae and Bradyrhizobiaceae and could correspondingly impact pest 

potential, the environment, or cultivation practices (i.e., need to add additional nitrogen to 

soybean production). Although differences in abundance of root nodules and corresponding 

nitrogen fixation have been identified between Roundup Ready® soybeans and other varieties, no 

definite conclusions regarding detrimental effects of the interactions of glyphosate with soil and 

plant microbial communities can be made (Kremer, 2010). Other factors which impact soil 

microorganisms include soil moisture and temperature, soil type, soil organic matter content, 

soybean variety, soil nutrient status, and crop cultivation practices, including crop rotation and 

tillage (Kremer, 2010). The potential impacts of the modified fatty acid on this symbiotic 

relationship are discussed in Subsection 4.4.4 of this report in the analysis of potential impacts to 

microorganisms. 

Glyphosate is readily metabolized by soil bacteria, and many species of soil microorganisms can 

use glyphosate as the sole carbon source (USDA-FS, 2003). Microorganisms produce aromatic 

amino acids through the shikimate pathway, similar to plants (USDA-FS, 2003). Because 

glyphosate inhibits this pathway, it could be expected that glyphosate would be toxic to 

microorganisms. However, field studies show that glyphosate has little effect on soil 

microorganisms, and, in some cases, field studies have shown an increase in microbial activity 

due to the presence of glyphosate (USDA-FS, 2003). 

Glyphosate use has been identified as potentially causing increases in certain disease-causing 

microbes (Fernandez et al., 2009; Kremer, 2010). Reported increases in infections from 

pathogenic soil fungi have been determined to be more closely related to reduced tillage and 

continuous cropping using herbicide-tolerant crops, rather than application of glyphosate 

(Fernandez, et al., 2009). 

2.4.5 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 crops 

within the system; 3) intensity of management; and 4) extent of isolation of the agroecosystem 
DRAFT MONSANTO 87705 SOYBEAN 

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from natural vegetation (Altieri, 1999; Palmer, Bromley, & Anderson, 2010). The reintroduction 

of woodlots, fencerows, hedgerows, wetlands, etc. has been used to reintroduce biodiversity into 

large scale monocultures. Other enhancement strategies 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). 

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. The use of broadspectrum insecticides/herbicides is one of the most severe constraints for biological diversity in 

crops (USDA-APHIS, 2010c). Tillage, seed bed preparation, planting of a monoculture crop, 

pesticide use, fertilizer use, and harvest may all limit the diversity of plants and animals (Lovett, 

Price, & Lovett, 2003). 

Herbicide use in agricultural fields is likely to indirectly impact biodiversity by decreasing weed 

species present in the field and those insect, bird and mammals that utilize these weeds. Ninetyeight percent of soybean acreage in the U.S. was treated with glyphosate in 2005 (USDA-NASS, 

2006). 

2.5 PUBLIC HEALTH 

2.5.1 Worker Safety 

The planting of Roundup Ready® soybean and attendant application of glyphosate on the 

soybean crop has become the standard weed control program in U.S. soybean production 

(Rogan, 2010). In the agricultural production of soybean, growers may be exposed to 

glyphosate-based herbicides and other pesticides during application of these chemicals to crops. 

Williams et al. (2000) have conducted a comprehensive human safety evaluation and risk 

assessment of glyphosate, and have concluded that glyphosate has low toxicity to mammals, is 

not a carcinogen, does not adversely affect reproduction and development, and does not 

bioaccumulate in mammals. 

According to the Reregistration Eligibility Decision (RED) document for glyphosate (US-EPA, 

1993a, 1993b), glyphosate is of relatively low oral and dermal acute toxicity. For this reason, 

glyphosate has been assigned to Toxicity Categories III and IV for these effects (i.e., Toxicity 

Category I indicates the highest degree of acute toxicity, and Category IV the lowest). An acute 

inhalation study was waived by EPA because glyphosate is a non-volatile solid (vapor pressure - 

7.5x10-8 mmHg, see Schuette, 1998) and the studies conducted on the end-use product 

formulation are considered sufficient (US-EPA, 1993b). Toxicological reviews from EPA 

(1993b) and the World Health Organization (2005) are in agreement that glyphosate does not 

pose any human acute exposure concerns for dietary exposures and thus negated the need to 

establish an acute reference dose. 
DRAFT MONSANTO 87705 SOYBEAN 

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With regard to subchronic and chronic toxicity, one of the more consistent effects of dietary 

exposure to glyphosate at high doses is reduced body weight gain compared with that in controls. 

Body weight loss is not seen in multiple subchronic studies, but has at times been noted in some 

chronic studies at excessively high doses ≥ 20,000 ppm (i.e., 2%) in diet (WHO, 2005). Other 

general and non-specific signs of toxicity from subchronic and chronic exposure to glyphosate 

include changes in liver weight, blood chemistry (may suggest mild liver toxicity), and liver 

pathology (USDA-FS, 2003). Glyphosate is not considered a carcinogen; it has been classified 

by EPA as a Group E carcinogen (evidence of non-carcinogenicity for humans) (US-EPA, 

1993b). 

In its human health analysis, EPA considered the potential applicator and bystander exposure 

resulting from increased glyphosate use. Based on the toxicity of glyphosate and its registered 

uses, including use on glyphosate-tolerant crops, EPA concluded that occupational exposures 

(short-term dermal and inhalation) to glyphosate are not of concern because acute and 

subchronic dermal or inhalation exposure exhibited no significant adverse effects (US-EPA 

2006; 71 FR 76180). 

2.5.2 Human Health 

Public health concerns surrounding GE soybean primarily involve the human consumption of GE 

soybean products. Non-GE soybean varieties, both those developed for conventional use and 

for use in organic production systems, are not routinely required to be evaluated by any 

regulatory agency in the U.S. for food safety prior to release in the market. Under the 

Federal Food, Drug, and Cosmetic Act (FFDCA), it is the responsibility of food 

manufacturers to ensure that the products they market are safe and properly labeled. Food 

derived from GE soybean must be in compliance with all applicable legal and regulatory 

requirements. GE organisms for food 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 

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

Monsanto has provided the FDA with information on the identity, function, and characterization 

of the genes, including expression of the gene products. The submittal to the FDA included 

information on the safety of the improved fatty acid profile in MON 87705 Soybean oil, 

including a dietary risk assessment. A copy of the completed FDA review is provided in 

Appendix A. 

2.6 ANIMAL FEED 

Animal feed concerns surrounding GE soybean primarily involve the animal consumption of GE 

soybean products. Non-GE soybean varieties, both those developed for conventional use and 

for use in organic production systems, are not routinely required to be evaluated by any 

regulatory agency in the U.S. for feed safety prior to release in the market. Under the 
DRAFT MONSANTO 87705 SOYBEAN 

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Federal Food, Drug, and Cosmetic Act (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 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. 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 

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

Soybean meal is a substantial part of animal feed. 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%)(SoyStats, 

2010g, 2010h). 

Monsanto has provided the FDA with information on the identity, function, and characterization 

of the genes, including expression of the gene products in MON 87705 Soybean. The submittal 

to the FDA included information on the safety of the improved fatty acid profile in MON 87705 

Soybean oil, including a dietary risk assessment. A copy of the completed FDA review is 

provided in Appendix A. 

2.7 SOCIOECONOMIC ISSUES 

Soybean first entered North America in the 18th century (Hoeft, et al., 2000). Sometime during 

the 1930s, soybean was processed industrially in the U.S. for edible oil and protein meal. 

Currently, the U.S. produces approximately 38% of the global soybean supply (SoyStats, 2010a). 

In 2009, the U.S. exported 1.3 billion bushels (34.9 million metric tons) of soybean, which 

accounted for 46% of the world's soybean exports (SoyStats, 2010b). In total, the U.S. exported 

$16.5 billion USD worth of soybean and soybean products globally in 2009 (SoyStats, 2010c). 

China is the largest export market for U.S. soybean with purchases totaling $9.2 billion. Mexico 

is the second largest export market with sales of $1.3 billion in the same year (SoyStats, 2010c). 

Other significant markets include Japan and the EU. 

The major producers of soybean are the U.S., Brazil, Argentina, China, and India, which 

accounted for approximately 91% of the global soybean production in 2007 (Soyatech, 2010); 

also see Table 2-4. Soybeans produced in China and India are primarily for domestic use. A 

significant portion of soybean produced in the U.S., Brazil, and Argentina is traded globally in 

the form of soybean harvested seed, soybean meal, or soybean oil (Rogan, 2010). Globally, the 

U.S. was the largest soybean seed export country; whereas Argentina led the soybean meal and 

soybean oil export markets in 2007 (Soyatech, 2010). 

Table 2-4: World Soybean Production 2009 

Country Production (million metric tons) 

U.S. 80.7 

Brazil 57.0 
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Country Production (million metric tons) 

Argentina 32.0 

China 15.5 

Canada 9.3 

India 9.1 

Paraguay 3.9 

Other 9.3 

TOTAL PRODUCTION 210.9 

Source: (Soyatech, 2008, 2010; SoyStats, 2010a). 

Managing production costs is a major component to the economics of producing a soybean crop. 

Key cost decisions include the choice of which soybean varieties to plant, the amount of fertilizer 

to apply, and which herbicide program to use. The average operating cost for producing soybean 

in the U.S. in 2006 was $93.41 per acre, with the value of the production less operating cost was 

reported to be $161.43 per acre (USDA-ERS, 2006a). 

The domestic food use of soybean oil is mainly in frying oils, salad and cooking oils, and 

margarines (SoyStats, 2010f). In 2009, these three categories represented approximately 

85% of the soybean market in the U.S., with industrial uses consuming the remaining 15% 

(SoyStats, 2010f; USSEC, 2006). Soybean oil industrial uses include plastics, lubricants, 

coatings, printing inks and adhesives, emulsifiers, surfactants (industrial detergents and 

cleaners as well as solvents), resins, and biodiesel, among others (APAG, 2011; USB, 

2010). Soy-based industrial oil products have many advantages in the marketplace, 

including being inherently biodegradable, having low ecotoxicity, and being derived from 

renewable resources (USSEC, 2006). The extraction of oil from soybeans also creates a 

highly valued solid, soybean meal, which is used for animal food in all sectors (swine, beef, 

poultry, dairy and fish) and human food protein (tofu, soymilk, meat substitutes, protein 

powder and soynuts) (Soyconnection, 2011). Changes in fatty acid profile may impact food 

and industrial uses of the soybean oil. Fatty acid composition of the soybean oil impacts 

melting point, oxidative stability, and chemical functionality, and changes in any of these 

can impact the market sector for the product (APAG, 2011). Table 2-5 illustrates several of 

the key physical properties of the fatty acid constituents of soybean oil. 

Table 2-5: Properties of Select Fatty Acids

Fatty Acid 

Fatty Acid 

Lipid 

Number1 Saturated Unsaturated MP (oC) BP (oC) 

Palmitic Acid C16 X 62.9 167 

Stearic Acid C18 X 70 361.6 

Oleic Acid C18:1 X 14 286 

Linoleic Acid C18:2 X -5 228 

Linolenic Acid C18-3 X -11 230 

Note: 

1. As noted in Table 2-1, fatty acids are identified based on the number of carbon atoms and the number 

of double bonds in that fatty acid. 

Source: (CRC, 2011) 

Palmitic and stearic acids are considered saturated fatty acids, indicating that they do not 

have any carbon double bonds. Oleic acid is a mono-unsaturated fatty acid, containing a 
DRAFT MONSANTO 87705 SOYBEAN 

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single double bond, and linoleic and linolenic acids are polyunsaturated fatty acids, 

containing 2 and 3 double bonds, respectively (APAG, 2011; SDA, 1965). Generally, the 

longer the carbon chain for saturated fatty acids, the higher the melting point, and the more 

unsaturated, the lower the melting point (APAG, 2011). 

These fatty acid properties influence the market applications for the oil, and various foods 

and industrial products are formulated to take these properties into consideration. Many of 

the commercial soy oils are a carefully blended mix to take advantage of the properties of 

the constituent fatty acids. Commercial stearic acid, for example, commonly used as a 

dispersing agent, a soap and detergent constituent, and in certain rubber products, is 

marketed as a mixture of 45% palmitic acid, 50% stearic acid, and 5% oleic acid (APAG, 

2011). A soy oil with a high content of oleic acid and low content of polyunsaturated fatty 

acids result in an oil with high oxidative stability, a critical property for industrial lubricants, 

as well as achieving the food industry goals to present a soy-based oil with lower 

concentrations of trans fatty acids (Cahoon, 2003; Soyconnection, 2011). 

A key element of the acceptability of soybean oil as a feedstock is the availability of product 

with a consistent and specific fatty acid composition (Cahoon, 2003). The identity 

protection systems detailed above in Subsection 2.2.4, Specialty Soybean Production, 

provides controls to ensure that the product characteristics cultivated in the field are 

preserved through to the ultimate use. Monsanto intends to market MON 87705 Soybean as 

a specialty soybean in order to segregate the crop from the commodity soybean at all stages 

its cultivation from seed production through and including handling and processing so as to 

preserve the special fatty acid composition (Rogan, 2010). 

The United Soybean Board has recently assessed the potential impact of rising petrochemical 

prices on soy uses for industrial applications (USB, 2010). Economic conditions and 

performance attributes of soy products, when compared with conventional petrochemical based 

products, favored soy as an industrial product and feedstock (USB, 2010). 
DRAFT MONSANTO 87705 SOYBEAN 

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3 ALTERNATIVES 

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of MON 87705 Soybean. To respond favorably to a petition for 

nonregulated status, APHIS must determine that MON 87705 Soybean is unlikely to pose a plant 

pest risk. Based on its risk assessment, Determination of Plant Pest Risk for Monsanto Improved 

Fatty Acid Profile MON 87705 Soybean, Glycine max (USDA-APHIS, 2010a) APHIS has 

concluded that MON 87705 Soybean is unlikely to pose a plant pest risk. Therefore APHIS must 

determine that MON 87705 soybean is no longer subject to 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act. 

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

nonregulated status of MON 87705 soybean. APHIS has assessed the potential for 

environmental impacts for each alternative in the “Environmental Consequences” section

3.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE 

Under the No Action Alternative, APHIS would deny the petition. MON 87705 Soybean and 

progeny derived from MON 87705 Soybean would continue to be regulated articles under the 

regulations at 7 CFR Part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions of MON 87705 Soybean and measures to ensure physical and 

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

alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation of MON 87705 Soybean. 

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

Pest Risk Assessment, Determination of Plant Pest Risk for Monsanto Improved Fatty Acid 

Profile MON 87705 Soybean, Glycine max (USDA-APHIS, 2010a) that MON 87705 Soybean is 

unlikely to pose a plant pest risk. 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 87705 

SOYBEAN IS NO LONGER A REGULATED ARTICLE 

Under this alternative, MON 87705 Soybean and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR Part 340. MON 87705 Soybean is unlikely to 

pose a plant pest risk (USDA-APHIS, 2010a). Permits issued or notifications acknowledged by 

APHIS would no longer be required for introductions of MON 87705 Soybean and progeny 

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

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

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

the agency has concluded that MON 87705 soybean are unlikely to pose a plant pest risk, a 

determination of nonregulated status of MON 87705 soybean is a response that is consistent 

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

biotechnology regulatory policies in the Coordinated Framework. Under this alternative, 
DRAFT MONSANTO 87705 SOYBEAN 

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growers may have future access to MON 87705 Soybean and progeny derived from this event if 

the developer decides to commercialize MON 87705 Soybean. 

3.3 ALTERNATIVES CONSIDERED BUT REJECTED FROM FURTHER 

CONSIDERATION 

APHIS assembled a list of alternatives that might be considered for MON 87705 Soybean. 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 forMON 87705 Soybean. 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 87705 Soybean 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 87705 Soybean, including 

denying any permits associated with the field testing. APHIS determined that this alternative is 

not appropriate given that APHIS has concluded that MON 87705 Soybean is unlikely to pose a 

plant pest risk (USDA-APHIS, 2010a). 

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) (see 7 U.S. C. §7701(4)). 

On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

implementation of policies for oversight of emerging technologies (such as genetic engineering) 

at the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563 and, consistent with that Executive Order, the following principle, among others, to 

the extent permitted by law, when regulating emerging technologies: 

“[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

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

each agency” 

Based on our Plant Pest Risk Assessment (USDA-APHIS, 2010a) and the scientific data 

evaluated therein, APHIS concluded that MON 87705 are unlikely to pose a plant pest risk. 

Accordingly, there is no basis in science for prohibiting the release of MON 87705.
DRAFT MONSANTO 87705 SOYBEAN 

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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 87705 Soybean is unlikely to pose a plant pest risk, there is no 

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

approval of the petition only in part. 

3.3.3 Isolation Distance between MON 87705 Soybean and Non-GE Soybean Production 

and Geographic Restrictions

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance of MON 87705 Soybean and non-GE soybean 

production. However, because APHIS has concluded that MON 87705 Soybean is unlikely to 

pose a plant pest risk (USDA-APHIS, 2010a), an alternative based on requiring isolation 

distances would be inconsistent 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 87705 Soybean based on the location of production of nonGE soybean in organic production systems or production systems for GE-sensitive markets in 

response to public concerns regarding possible gene movement between GE and non-GE plants. 

However, as presented in APHIS’ plant pest risk assessment for MON 87705 Soybean, there are 

no geographic differences associated with any identifiable plant pest risks for MON 87705 

Soybean (USDA-APHIS, 2010a). This alternative was rejected and not analyzed in detail 

because APHIS has concluded that MON 87705 Soybean does not pose a plant pest risk, and 

will not exhibit a greater plant pest risk in any geographically restricted area. Therefore, such an 

alternative would not be consistent with APHIS’ statutory authority under the plant pest 

provisions 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. Nevertheless, APHIS is not expecting significant effects. 

However, individuals might choose on their own to geographically isolate their non-GE soybean 

production systems from MON 87705 Soybean, or to use isolation distances and other 

management practices to minimize gene movement between soybean fields. Information to 

assist growers in making informed management decisions for MON 87705 Soybean is available 

from Association of Official Seed Certifying Agencies (AOSCA, 2010). 

3.3.4 Requirement of Testing for MON 87705 Soybean 

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 87705 Soybean does not pose a plant pest 
DRAFT MONSANTO 87705 SOYBEAN 

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risk(USDA-APHIS, 2010a), 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 

the biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for MON 87705 Soybean would not meet APHIS’ purpose and 

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

COMPARISON OF ALTERNATIVES 

Table 3-1 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 3-1: Summary 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, 2010a) 

Management Practices 

Acreage and Areas of Soybean 

Production Unchanged Unchanged 

Seed Production Unchanged Unchanged 

Organic Farming Unchanged Unchanged 

Specialty Soybean Unchanged Unchanged 

Soybean Cultivation Practices Unchanged Unchanged 

Physical Environment 

Water Resources Unchanged Unchanged 

Soil and Land Use Unchanged Unchanged

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Biological Resources 

Gene Movement and Weediness Unchanged Unchanged 

Animals Unchanged Unchanged 

Plants Unchanged Unchanged 

Microorganisms Unchanged Unchanged 

Biodiversity Unchanged Unchanged 

Human Health 

Worker Safety Unchanged Unchanged 

Human Health Unchanged Unchanged (potential health 

benefits) 

Animal Feed Unchanged Unchanged 

Socioeconomic 

Domestic Economic Environment Unchanged Unchanged 

Trade Economic Environment Unchanged Unchanged 

Social Environment Unchanged Unchanged 
DRAFT MONSANTO 87705 SOYBEAN 

 40 

Attribute/Measure Alternative A: No Action 

Alternative B: 

Determination of 

Nonregulated Status 

Threatened and Endangered Species Unchanged Unchanged 

Other U.S Regulatory Approvals FDA completed 

consultations

FDA completed 

consultations

Compliance with Other Laws 

CWW, CAA, EOs Fully compliant Fully compliant 

Notes: 

1. Unchanged – the current conditions will not change as a result of the selection of this alternative. 

2. Minimal – the current conditions may change slightly as a result of the selection of this alternative, but the changes, if 

any, are not deemed significant. 
DRAFT MONSANTO 87705 SOYBEAN 

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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 Monsanto 87705 Soybean does not pose a plant pest 

risk. 

Potential environmental impacts from the No Action Alternative and the Preferred 

Alternative for MON 87705 Soybean are described in detail throughout this section. A 

cumulative effects analysis is also included for each environmental issue. Certain aspects of 

this product and its cultivation would result in no differences of consequences deriving from the 

alternatives; those are described below. 

SCOPE OF THE ENVIRONMENTAL ANALYSIS 

For the discussion of environmental consequences, the following principal areas of potential 

environmental concern have been evaluated: 

 Soybean Production (Subsection 4.2); 

 Physical Environment (Subsection 4.3); 

 Biological Resources (Subsection 4.4); 

 Public Health (Subsection 4.5); 

 Animal Feed (Subsection 4.6); 

 Socioeconomics Issues (Subsection 4.7); 

 Threatened and Endangered Species (Subsection 4.8); 

 Other Cumulative Effects (Subsection 4.9); and 

 Consideration of Executive Orders, Standards, and Treaties Relating to Environmental 

Impacts (Subsection 4.10). 

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 the possibility of breeding MON 87705 

Soybeans with GE soybeans that have been deregulated pursuant to Part 340 and the Plant 

Protection Act (i.e., “stacked” traits) including herbicide tolerance or with conventional 

traits. If there are no direct or indirect impacts identified for a resource area, then there can 

be no cumulative impacts. 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. 

Although the Preferred Alternative would allow for new plantings of MON 87705 Soybean to 

occur anywhere in the U.S., APHIS will limit the environmental analysis to those areas that 

currently support soybean production (see Table 2-2). The environmental consequences of No 

Action and Preferred Alternatives will be analyzed under the assumption that farmers, who 

produce conventional soybean, MON 87705 Soybean, or produce soybean using organic 

methods, are using reasonable, commonly accepted best management practices for their chosen 

system and varieties during agricultural soybean production. However, APHIS recognizes that 
DRAFT MONSANTO 87705 SOYBEAN 

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not all farmers follow these best management practices for soybean. Thus, the analyses of the 

environmental effects will also include the assumption that some farmers do not follow these 

best management practices. 

4.1 SOYBEAN PRODUCTION 

One of APHIS’s missions is to improve American agricultural productivity. Best management 

practices are commonly accepted, practical ways to grow soybean, regardless of whether the 

soybean farmer is using conventional practices with non-GE or GE varieties, or using organic 

practice. These management practices consider crop-specific planting dates, seeding rates, and 

harvest times, among others. Over the years, soybean production has resulted in wellestablished, widely-practiced management practices that are available through local Cooperative 

Extension Service offices and their respective websites. The National Information System for 

the Regional Integrated Pest Management Centers (IPM Centers) publishes crop profiles for 

major crops on a state-by-state basis. These crop profiles provide production guidance for local 

growers, including recommended practices for specific pest control. Crop profiles for many of 

the soybean production states are available at: www.ipmcenters.org/cropprofiles/index.cfm. 

Monsanto’s field trials have not demonstrated any agronomic or phenotypic differences between 

MON 87705 Soybean and control varieties of soybean (Rogan, 2010). Based on the data 

provided by Monsanto for MON 87705 Soybean (Rogan, 2010), as well as previous experience 

with other GE soybean varieties that have been widely adopted by growers since their 

introduction in 1996 (USDA-ERS, 2010a), APHIS has concluded that none of the best 

management practices for agricultural production of soybean are expected to change if MON 

87705 Soybean is deregulated. Consistent with the lack of changes to agronomic properties, the 

potential impacts on agricultural production associated with the No Action and Preferred 

alternatives are the same. 

4.1.1 Acreage and Areas of Soybean Production 

GE and non-GE soybean varieties are continually under development. In 2009 and 2010, over 

75 million acres in the U.S. were planted in soybean, with over 93% of the soybean expressing 

herbicide tolerance (USDA-ERS, 2010a, 2010b). 

No Action: Acreage and Areas of Soybean Production 

Based on current acreage trends, soybean production with GE varieties will likely continue to 

dominate. Cultivation of GE soybean increased from 17% of the U.S. soybean acreage in 1997, 

to over 93% in 2010. The continued cultivation of soybean and the penetration of the soybean 

market by GE varieties is not expected to change under the No Action Alternative. Soybeans are 

currently produced commercially in 31 states (USDA-NASS, 2010a) and under the No Action 

Alternative, this range of production is not expected to change. 

Preferred Alternative: Acreage and Areas of Soybean Production 

Monsanto plans to market MON 87705 Soybean as a specialty variety to take full advantage of 

the modified fatty acid composition of this product (Rogan, 2010). Monsanto’s field trials have 

not demonstrated any agronomic or phenotypic differences between MON 87705 Soybean and 
DRAFT MONSANTO 87705 SOYBEAN 

 43 

control varieties of soybean (Rogan, 2010). The changes in fatty acid composition and the 

tolerance to the herbicide glyphosate expressed in MON 87705 Soybean do not require changes 

in cultivation practices when compared with other glyphosate-tolerant soybean varieties (Rogan, 

2010). MON 87705 Soybean does not confer an increase in cold tolerance, heat resistance, or 

drought tolerance (these issues are discussed again below in the subsection on gene flow) and 

therefore MON 87705 Soybean is not anticipated to be cultivated in new regions outside of the 

current soybean production areas. MON 87705 Soybean is anticipated to replace plantings of 

both conventional and existing GE varieties where those growers seek to cultivate a specialty 

soybean variety to take advantage of the changed fatty acid composition of this product in 

conjunction with the tolerance to glyphosate (Rogan, 2010). Under the Preferred Alternative, a 

determination of nonregulated status of MON 87705 Soybean is not expected to increase 

soybean production, or result in an increase in overall GE soybean acreage or cultivation in new 

regions. Impacts would be similar to the No Action Alternative. 

Cumulative Effects: Acreage and Areas of Soybean Production 

Cumulative effects of a determination of nonregulated status of MON 87705 Soybean are 

unlikely. Neither the No Action Alternative nor a determination of nonregulated status of 

MON 87705 Soybean is expected to directly cause an increase in agricultural acreage devoted to 

soybean production or those soybean acres devoted to GE soybean cultivation. The 

availability of MON 87705 Soybean is not expected to change cultivation areas for soybean 

production in the U.S.; and there are no anticipated changes to the availability of GE and non-GE 

soybean varieties on the market under either alternative. 

4.1.2 Seed Production 

Soybean seed production is managed through AOSCA standard procedures to preclude gene 

flow between varieties (Bradford, 2006; Sundstrom, et al., 2002). Soybean is considered a selfpollinated species, exhibiting a high-percentage of self-fertilization (OECD, 2000). Common 

practices to preserve varietal identity include: 1) maintaining isolation distances to prevent 

pollen movement from other soybean sources; 2) planting border or barrier rows to intercept 

pollen, employing natural barriers to pollen; and 3) field monitoring for off-types, other crops, 

weeds, and disease. 

No Action: Seed Production 

Under the No Action Alternative, current soybean seed production practices are not expected 

to change. 

Preferred Alternative: Seed Production 

Monsanto’s field trials have not demonstrated any agronomic or phenotypic differences between 

MON 87705 Soybean and control varieties of soybean (Rogan, 2010). Based on the data 

provided by Monsanto for MON 87705 Soybean (Rogan, 2010), as well as previous experience 

with other GE soybean varieties that have been widely adopted by growers since their 

introduction in 1996 (USDA-ERS, 2010a), APHIS has concluded that the availability of MON 

87705 Soybean would not alter the agronomic practices, locations, and the production and 
DRAFT MONSANTO 87705 SOYBEAN 

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quality characteristics of conventional and GE seed production (USDA-APHIS, 2010a). The 

overall impact of a determination of nonregulated status of MON 87705 Soybean on the 

availability of conventional and GE seed, and the production practices used to grow soybean 

seeds would be similar to the No Action Alternative. Accordingly, there are no differences 

between the No Action and Preferred Alternatives with regard to seed production. 

Cumulative Impacts: Seed Production 

Based on current acreage trends, GE soybean varieties will likely continue to dominate the 

market. Since 2007, the GE varieties of soybean have comprised 91 to 93% of the U.S. soybean 

acreage. Changes in the agronomic practices and locations for soybean seed production using 

MON 87705 Soybean are not expected. The availability of MON 87705 Soybean will not 

change cultivation areas for soybean seed production in the U.S.; no cumulative effects have 

been identified for this issue. 

4.1.3 Organic Farming 

Organic production plans prepared pursuant to the National Organic Program (NOP) include 

practical methods to protect organically-produced crops from accidental contamination with 

genetically engineered materials. Typically, organic growers use more than one method to 

maintain organic certification and prevent unwanted material from entering their fields 

including: isolation of the farm, physical barriers or buffer zones between organic production 

and non-organic production, as well as formal communications between neighboring farms 

(Baier, 2008; Kuepper, 2003; NCAT, 2003). These practices follow the same system as that 

utilized for the cultivation of certified seed under the AOSCA procedures. 

APHIS recognizes that producers of non-GE soybean, particularly producers who sell their 

products to markets sensitive to GE traits (e.g., organic or some export markets), can be 

reasonably assumed to be using practices on their farm to protect their crop from unwanted 

substances and maintain their price premium. APHIS will assume that growers of organic 

soybean are already using, or have the ability to use, these common practices as a baseline, 

which APHIS uses for the analyses of the alternatives below. 

Historically, organic soybean production represents a small percentage of total U.S. soybean 

acreage (USDA-ERS, 2010e). In 2005, 122,217 acres of soybean in U.S. were certified organic, 

and in 2008, 125,621 acres were similarly certified (USDA-ERS, 2010e), representing between 

0.17% and 0.22%, respectively, of the soybean production in the U.S. In 2001, 68% of the 

soybean crop was herbicide-tolerant, and by 2010 93% of the total acreage was herbicidetolerant (USDA-ERS, 2010a, 2010b, 2010e). 

No Action: Organic Farming 

Current availability of conventional (both GE and non-GE) soybean varieties, and those soybean 

varieties that are developed for organic production, are expected to remain the same under the 

No Action Alternative. Since 2001, GE varieties of soybean have dominated the market, 

representing 68% of the market in 2001, and 93% of the market in 2010 (USDA-ERS, 2010a). 

Although organic soybeans have a place in the market, the respective share is small, and the 
DRAFT MONSANTO 87705 SOYBEAN 

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dedicated acreage appears to be steady. Between 2005 and 2008, the total acreage devoted to 

soybean fluctuated between 72 million and 64 million acres, although organic soybeans ranged 

from 122,000 to 126,000 acres, less than 1% of the total soybean acreage (USDA-ERS, 2010e). 

The market share for organic soybean varieties is not expected to change under the No Action 

Alternative (USDA-ERS, 2010a; USDA-NASS, 2007, 2010e). 

Preferred Alternative: Organic Farming 

It is not likely that organic farmers, or other farmers who choose not to plant transgenic varieties 

or sell transgenic seed, will be substantially impacted by APHIS’ a determination of 

nonregulated status of MON 87705 Soybean. 

GE soybean varieties are currently cultivated on 93% of the U.S. soybean acreage (USDA-ERS, 

2010a), and organic varieties comprise less than 1% of the total soybean acreage (USDA-ERS, 

2010e). MON 87705 Soybean should not present any new or different issues and impacts for 

organic and other specialty soybean producers and consumers. 

According to the petition, agronomic trials conducted in 2007 at 17 field locations in the U.S. 

demonstrated that MON 87705 Soybean is not significantly different in plant growth, yield, and 

reproductive capacity from its nontransgenic counterpart (Rogan, 2010; USDA-APHIS, 2010a). 

No differences were observed in pollen diameter, weight, and viability (Rogan, 2010; USDAAPHIS, 2010a). Consistent with the lack of difference in agronomic properties, MON 87705 

Soybean is not expected to have an increased ability to cross pollinate other soybean varieties. 

The practices currently employed to preserve and maintain purity of organic production systems 

would not be required to change to accommodate the production of MON 87705 Soybean. 

Commonly used production practices for soybean and the practical methods typically used 

by soybean farmers using organic methods to protect their crop under organic production 

(NCAT, 2003) provide many measures that greatly reduce the likelihood of accidental gene flow 

between MON 87705 Soybean and non-GE soybean fields. 

MON 87705 Soybean will be marketed by Monsanto as a specialty variety to take advantage 

of the altered fatty acid composition (Rogan, 2010). Consistent with lack of differences in 

agronomic practices, and the specialty soybean market intentions, MON 87705 Soybean is 

not expected to displace current organic soybean production. 

The acreage devoted to organic soybean is expected to remain small regardless of whether 

new varieties of GE or non-GE soybean varieties, including MON 87705 Soybean, become 

available for commercial soybean production. As noted above for the time period of 2005 

to 2008, when the total U.S. acreage dedicated to soybean fluctuated between 72 million and 

64 million acres, the acreage devoted to organic soybeans was relatively stable, reported 

between 122,000 and 126,000 acres (USDA-ERS, 2010e). Consistent with these cultivation 

trends, a determination of of MON 87705 Soybean is not expected to have a significant impact 

on organic soybean growers. 
DRAFT MONSANTO 87705 SOYBEAN 

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Cumulative Effects: Organic Farming 

A determination of nonregulated status of MON 87705 Soybean is not expected to change the 

market demands for GE soybean or soybean produced using organic methods. A 

determination of nonregulated status of MON 87705 Soybean will add another GE soybean 

variety to the conventional soybean market. Based upon recent trend information, adding GE 

varieties to the market is not related to the ability of organic production systems to maintain their 

market share. 

4.1.4 Specialty Soybean Production 

Specific market uses for specialty soybean products generally require adherence to specialty crop 

practices to preserve identity from seed production through harvesting, handling, and processing. 

A premium is paid to growers and processors for delivering product that meets these desired 

purity and quality standards (Elbehri, 2007; Lee & Herbek, 2004; Muth, Mancini, & Viator, 

2003; Pritchett, Fulton, Beyers, Pederson, & Lawson, 2002; Smyth & Phillips, 2002; Sundstrom, 

et al., 2002). Specialty soybean crop growers employ these identity protection practices and 

standards to not only ensure that identity is preserved, but also to ensure that their products are 

not pollinated by or commingled with conventional or genetically engineered crops (Bradford, 

2006; Cui, et al., 2004; Massey, 2002). These identity management practices include 

maintaining isolation distances to prevent pollen movement from other soybean sources, planting 

border or barrier rows to intercept pollen, employing natural barriers to pollen, and managing 

planting dates and various seed handling, transportation, and ginning procedures so as to 

maintain separation between specialty and commodity varieties (Bradford, 2006; NCAT, 2003; 

Sundstrom, et al., 2002). These management practices allow the grower to meet standards for 

the production of specialty crop seed, maintain genetic purity, and protect the genetic diversity of 

soybean (Bradford, 2006). 

No Action: Specialty Soybean Production 

Current availability of GE, non-GE, specialty and organic soybean varieties are expected to 

remain the same under the No Action Alternative. Since 2001, GE varieties of soybean have 

dominated the market, representing 68% of the market in 2001, and 93% of the market in 2010 

(USDA-ERS, 2010a). Specialty soybeans are produced on approximately 12% of the total U.S. 

acreage (MSA, 2009). The acreage dedicated to specialty soybeans is projected to increase to 

25% of the total acreage over the next decade (MSA, 2009). The market share for specialty 

soybean varieties is not expected to change under the No Action Alternative (USDA-ERS, 

2010a; USDA-NASS, 2007, 2010e). The cultivation of specialty soybean varieties is expected to 

remain the same under the No Action Alternative. 

Preferred Alternative: Specialty Soybean Production 

MON 87705 Soybean is expected to be cultivated as a high-value specialty soybean product, 

produced under identity protection system management practices so as to preserve the value of 

the oil (Rogan, 2010). As a specialty soybean variety, Monsanto anticipates that MON 87705 

would be cultivated following existing specialty crop practices to preserve product identity from 

seed production through harvesting, handling, and processing (Rogan, 2010). A premium is paid 
DRAFT MONSANTO 87705 SOYBEAN 

 47 

to growers and processors for delivering product that meets these desired purity and quality 

standards (Elbehri, 2007; Lee & Herbek, 2004; Muth, et al., 2003; Pritchett, et al., 2002; Smyth 

& Phillips, 2002; Sundstrom, et al., 2002). 

It is not likely that specialty system farmers, or other farmers who choose not to plant transgenic 

varieties or sell transgenic seed, will be substantially impacted by APHIS a determination of 

nonregulated status of MON 87705 Soybean. Specialty soybean varieties are already cultivated 

on 12% of the U.S. soybean acreage, and the industry anticipates that specialty soybean acreage 

could expand to over 25% of the crop in certain states within the next decade (MSA, 2009). The 

trend towards increasing cultivation of specialty soybeans has paralleled the adoption of GE 

soybeans, both commodity and specialty varieties. Cultivation of MON 87705 Soybean as a new 

specialty soybean variety should not present any new or different issues and impacts for specialty 

soybean producers and consumers. That specialty soybeans comprise 12% of the total U.S. 

soybean acreage, where 93% of that same acreage is cultivated with GE soybean varieties, 

demonstrates that existing IP programs (e.g., the AOSCA identity protection and preservation 

systems) provide adequate assurance of variety and specialty characteristics. 

Data presented in Monsanto’s petition demonstrates that MON 87705 Soybean is not 

significantly different in plant growth, yield, and reproductive capacity from its nontransgenic 

counterpart (Rogan, 2010; USDA-APHIS, 2010a). No differences were observed in pollen 

diameter, weight, and viability. Consistent with the lack of changes to agronomic properties, 

MON 87705 Soybean is not expected to have an increased ability to cross-pollinate other 

soybean varieties or to require different cultivation or handling techniques from currently 

cultivated specialty soybean varieties. 

Cumulative Effects: Specialty Systems 

A determination of nonregulated status of MON 87705 Soybean is not expected to change the 

market demands for GE soybean or soybean produced using specialty systems. A determination 

of nonregulated status of MON 87705 Soybean will add another GE variety to the existing 

soybean market. MON 87705 Soybean is expected to be cultivated as a specialty soybean 

consistent with these practices. Based on demonstrated agronomic characteristics and cultivation 

practices, and because the market share of specialty soybean varieties is unlikely to change by 

the introduction of MON 87705 Soybean, APHIS has determined that there are no past, present, 

or reasonably foreseeable changes that would impact specialty soybean producers and 

consumers. 

4.1.5 Soybean Cultivation Practices 

Crop rotation in soybean is conducted to manage weeds, optimize soil nutrition and fertility, 

reduce pathogen loads, and control certain soybean pests (Al-Kaisi, et al., 2003; University of 

Illinois, 2006). The adoption of herbicide tolerance complements conservation tillage practices 

by allowing farmers to substitute glyphosate application for some tillage operations as a weed 

management practice (NRC, 2010). Benbrook (2009) notes that herbicide-tolerant soybean 

accounts for over two-thirds of the total acreage devoted to genetically engineered crops. 
DRAFT MONSANTO 87705 SOYBEAN 

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Volunteer soybean is normally not a concern. Soybean is not winter hardy, and existing 

mechanical and chemical methods are available to manage the occasional volunteer soybean. 

Benbrook has reported that the adoption of herbicide-tolerant crops has resulted in an increase in 

the volume of herbicides applied to crops (Benbrook, 2009). Benbrook notes that herbicide use 

declined between 1996 and 2001 apparently in direct response to the adoption of herbicidetolerant crops; however, since that time, herbicide use has increased (Benbrook, 2009). Reported 

increases in herbicide use reflect an increase in use of conventional herbicides as well as an 

increase in glyphosate applications as more glyphosate-tolerant crops are planted (Benbrook, 

2009). Currently, nine weeds have been identified as glyphosate-resistant, with seven of these 

weeds identified as difficult to control weeds in soybean: common ragweed (Ambrosia 

artemisiifolia), common waterhemp (Amaranthus rudis), giant ragweed (Ambrosia trifida), 

horsetail (marestail) (Conyza canadensis), Italian ryegrass (Lolium multiflorum), Johnsongrass 

(Sporghum halapense), and Palmer amaranth (Amaranthus palmeri) (Benbrook, 2009). 

No Action: Soybean Cultivation Practices 

Under the No Action Alternative, soybean crop rotation practices and herbicide pesticide use will 

likely remain as it is practiced today by the farming community. Growers will continue to have 

access to existing herbicide-tolerant soybean products previously deregulated pursuant to Part 

340 and the Plant Protection Act as well as conventional soybean varieties. 

Preferred Alternative: Soybean Cultivation Practices 

Monsanto’s studies demonstrate MON 87705 Soybean is essentially indistinguishable from other 

soybean varieties used in terms of agronomic characteristics and cultivation practices (Rogan, 

2010; USDA-APHIS, 2010a). The mechanism for glyphosate tolerance is the same as that 

expressed by other varieties, so the application rates for glyphosate are not expected to change 

(Rogan, 2010). Monsanto did not identify any differences between MON 87705 Soybean and 

conventional A3525 control soybeans in dormancy, germination potential, disease or insect 

response, seedling vigor, or plant maturity (Rogan, 2010; USDA-APHIS, 2010a). The similarity 

in agronomic and phenotypic characteristics suggests that the changes in fatty acid profile and 

the incorporation of glyphosate tolerance do not impact the ability of soybean to overwinter or 

become a volunteer. 

A determination of nonregulated status of MON 87705 Soybean is not expected to affect the use 

of glyphosate as a post-emergent weed herbicide. Other herbicides are available to control 

volunteer soybeans in corn, cotton, wheat, and rice (see Subsection 2.2.5.5, above). These 

herbicides are suitable for post-emergence control of volunteer soybean. The challenges which 

growers face in managing glyphosate-resistant weeds is also not expected to differ between 

MON 87705 Soybean and other glyphosate-tolerant varieties. 

Consistent with the demonstrated lack of agronomic difference, soybean crop rotation and 

herbicide use practices are expected to be unchanged under the Preferred Alternative. Overall 

impacts would be similar to the No Action Alternative. 
DRAFT MONSANTO 87705 SOYBEAN 

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Cumulative Effects: Soybean Cultivation Practices 

Soybean growers have other herbicide-tolerant variety options for soybean production in addition 

to those varieties expressing glyphosate tolerance; two mechanisms for this resistance are offered 

to growers: insensitive target enzyme and increased metabolism. LibertyLink® Soybean with 

glufosinate ammonium tolerance is available from numerous seed dealers (e.g., Stine Seed), as 

are STS soybeans, a conventionally derived resistance to ALS herbicides, which may be stacked 

with other resistance traits (e.g., Asgrow Seed). These options allow growers to reduce 

dependence on glyphosate, especially if glyphosate-resistant weeds are an important issue. 

Additional strategies to avoid development of glyphosate-resistant weeds can be used by growers 

and these include: 

 Developing a diversified weed management program using herbicides with different 

modes of action, either concurrently or sequentially (NRC, 2010). 

 Use the full recommended herbicide rate and proper application timing for the most 

difficult to control weeds in the field (NRC, 2010). 

 Scouting the fields after herbicide application to ensure that control has been achieved 

and to discourage weeds from reproducing or proliferating vegetatively (NRC, 2010). 

 Incorporate cultural practices such as cultivation, tillage and crop rotation, where 

appropriate (NRC, 2010). 

A determination of nonregulated status of MON 87705 Soybean will not result in changes in the 

current practices of crop rotation and pesticide use. Studies demonstrate MON 87705 Soybean is 

essentially indistinguishable from other soybean varieties used in terms of agronomic 

characteristics and cultivation practices (Rogan, 2010). It is anticipated that herbicide use will 

continue the trends noted by Benbrook associated with the wide adoption of glyphosate-tolerant 

soybean and the emergence of glyphosate-resistant weeds. APHIS has determined that there are 

no past, present, or reasonably foreseeable actions that would aggregate with effects of the 

proposed action to effect changes in crop rotation, and pesticide use.

4.2 PHYSICAL ENVIRONMENT 

4.2.1 Soil and Land Use 

The USDA National Resource Conservation Service has identified significant reductions in 

the loss of soil from croplands in the U.S., finding that total soil loss on highly erodible 

croplands and non-highly erodible cropland decreased by 39.2% from 1982 to 2003 (USDANRCS, 2006c). Herbicide-tolerant soybean has contributed to this reduction in soil loss 

through a shift towards conservation tillage and the use of cover crops where the cultivation 

of herbicide-tolerant varieties and attendant use of post-emergent herbicides replaces manual 

weed control techniques (University of Illinois, 2006; USDA-NRCS, 2010). Other benefits 

to soil of conservation tillage or no-till systems include lower dust generation, decreased 

fertilizer and pesticide use, reduced fuel and labor costs, and conservation of soil moisture. 

No Action: Soil and Land Use 

Land usage and agronomic practices associated with traditional and existing non-regulated GE 

soybean production would not be expected to change in response to the No Action 
DRAFT MONSANTO 87705 SOYBEAN 

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Alternative. No changes to the impacts to the soil environment are anticipated from the 

current agronomic practices associated with soybean production including tillage, cultivation, 

fertilization, pesticide applications, fertilizer applications, and the use of agricultural 

equipment. 

Preferred Alternative: Soil and Land Use 

No changes to agronomic practices typically applied in the management of conventional 

soybean, including other commercially available GE soybean varieties, are required for MON 

87705 Soybean. 

Monsanto’s field trial and laboratory analyses demonstrated that the agronomic performance of 

MON 87705 Soybean was functionally identical to its non-transgenic counterpart (Rogan, 2010). 

No increases in fertilizers and pesticides were required, nor were any changes in cultivation, 

planting, harvesting, and volunteer control required (Rogan, 2010). It is expected that similar 

agronomic practices that are currently used for commercially available GE soybean will also be 

used by growers of MON 87705 Soybean. 

If MON 87705 Soybean is adopted and replaces non-GE soybean varieties (currently less 

than 7% of US soybean ({USDA-ERS, 2010b #437}), soils currently under non-GE soybean 

production may experience short-term benefits from the use of MON 87705 Soybean due to a 

reduction in applications of herbicides and the number of acre-treatments per year using 

heavy farm equipment required for herbicide applications. However, as noted by Benbrook 

(2009) and others, if glyphosate use is not well managed, resistant weeds may emerge, 

requiring use of other herbicides, as well as field tillage for their control. 

Persistence of pesticides in soil is also favorably addressed by the cultivation of MON 87705 

Soybean. Glyphosate would likely be the predominant post-emergent herbicide applied to 

MON 87705 Soybean, as it is with other glyphosate tolerant soybean. Glyphosate has been 

shown to rapidly dissipate from most agricultural ecosystems across a wide range of soil and 

climatic conditions, with a median soil half-life (the time it takes for half of the glyphosate 

to dissipate in the soil) of 13 days (Giesy, Dobson, & Solomon, 2000). A survey reported 

by Borggard and Gimseng (2008) noted soil half-lives ranging from 1.2 to 197 days, 

depending on a wide range of soil chemical and physical parameters. 

Pesticide products approved for application to emerged weeds normally are applied with 

surfactants. Surfactants increase the permeability of the weed foliage to increase the foliar 

uptake of glyphosate and thereby improve the efficacy of the herbicide (Rogan, 2010). 

Polyethoxylated alkyl amine (POEA) is the predominant surfactant used in formulated 

glyphosate products. Glyphosate and the POEA surfactant have similar soil dissipation rates 

and the same primary route of dissipation, i.e., microbial degradation (Giesy, et al., 2000). 

The half-life of POEA in soil is estimated to range from 7 to 14 days (Giesy, et al., 2000). 

On that basis, the POEA surfactant is expected to behave similarly to glyphosate in field 

soil, and an increase in residual soil concentrations (accumulation) of the POEA surfactant 

is not anticipated. Because MON 87705 Soybean does not differ in its agronomic 

requirements from conventional soybean or other GE varieties expressing glyphosate 
DRAFT MONSANTO 87705 SOYBEAN 

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tolerance, agronomic practices associated with soil and land use are not expected to change 

with the availability of this new plant product. 

Cumulative Effects: Soil and Land Use 

APHIS has not identified any cumulative effects to soils. Comprehensive phenotypic, 

agronomic, and ecological assessments conducted by the petitioner for MON 87705 Soybean did 

not find significant differences between MON 87705 Soybean and control soybeans for these 

characteristics (Rogan, 2010). The few differences that were identified were typically small, site 

specific, and unlikely to be biologically meaningful. Event MON 87705 Soybean required the 

same soil, fertilizer, water and pest management practices as non-GE soybean (Rogan, 2010). 

Consequently, the phenotypic, agronomic, and ecological data presented by Monsanto (Rogan, 

2010) support the conclusion by APHIS that MON 87705 Soybean will not significantly modify 

soil characteristics associated with conventional soybean production practices. 

Based on these findings, and because the amount of soybean grown in the U.S. is unlikely to 

change by the introduction of MON 87705 Soybean, APHIS has determined that there are no 

past, present, or reasonably foreseeable actions that would aggregate with effects of the proposed 

action to impact soil. 

4.2.2 Water Resources 

The soils and climate in the Eastern, Midwestern and portions of the Great Plains of the U.S. 

provide sufficient water supplies under normal climatic conditions to produce a soybean crop. 

The adoption of herbicide-tolerant soybean varieties has been a factor in the adoption of 

conservation practices, including conservation tillage. 

Water quality is also preserved in modern soybean production systems. The increase in 

conservation tillage practices has resulted in a reduction of runoff from agricultural lands, 

decreasing non-point source pollution of fertilizer and pesticides. Intensive local monitoring of 

surface water and sub-soils has demonstrated the benefits of no-till soybean in protecting both 

ground and surface water resources(University of Illinois, 2006). 

Although glyphosate is very soluble in water, it is strongly adsorbed to soils; consequently, 

glyphosate is unlikely to leach into groundwater or surface water runoff following application 

(Giesy, et al., 2000; US-EPA, 1993b). Relying on toxicological data; bioaccumulation and 

biodegradation studies; and acute and chronic tests on fish and other aquatic organisms, EPA has 

determined that “the potential for environmental effects of glyphosate in surface water is 

minimal” (US-EPA, 1993b). 

No Action: Water Resources 

Under the No Action Alternative, land acreage and agronomic practices, including irrigation, 

associated with soybean production would not be affected. Current application rates of 

glyphosate for weed control are not expected to change. 
DRAFT MONSANTO 87705 SOYBEAN 

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Preferred Alternative: Water Resources 

In 2010, herbicide-tolerant soybeans were cultivated on 93% of the soybean acreage (USDAERS, 2009). The introduction of herbicide-tolerant crops has resulted in the adoption of 

conservation practices (Rogan, 2010; Sankula, 2006; University of Illinois, 2006). These 

conservation practices, including reduced tillage and precision agriculture play a significant role 

in water conservation and maintaining water quality by minimizing soil erosion (USDA-NRCS, 

2006b). 

MON 87705 Soybean does not change cultivation practices for soybean production, nor would it 

increase the total acres and range of U.S. soybean production areas. A determination of 

nonregulated status of MON 87705 Soybean will not change water use in soybean production, 

as the MON 87705 Soybean is expected to simply replace GE and non-GE soybean varieties 

already in use. 

Current application rates of glyphosate for weed control are not expected to change. Based on 

the above information, the consequences of the Preferred Action Alternative on water use are the 

same as the No Action Alternative.

Cumulative Effect: Water Resources 

No cumulative effects on water use have been identified associated with a determination of 

nonregulated status of MON 87705 Soybean. A determination of nonregulated status of MON 

87705 Soybean will not change the water use and irrigation practices used in commercial 

soybean production. 

4.2.3 Air Quality and Climate Change 

Traditional agricultural practices have the potential to cause negative impacts to air quality. 

Agricultural emission sources include smoke from agricultural burning, tillage, traffic and 

harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the use of 

nitrogen fertilizer (Aneja, et al., 2009; USDA-NRCS, 2006a). Other greenhouse gas (GHG) 

emission sources associated with agricultural production include equipment emissions 

(contributing carbon monoxide, nitrogen oxides, and reactive organic gases), particulate matter, 

sulfur oxides, and direct emissions of N2O from fertilizer application (US-EPA, 2010). 

The adoption of herbicide-tolerant soybean has reduced air emissions, including GHG, due to the 

increased adoption of conservation practices (NRC, 2010). Conservation practices, including 

conservation tillage associated with GE soybean production, requires fewer tractor passes across 

a field (Baker, et al., 2005; USDA-NRCS, 2006a). This results in a decrease in dust generation 

and tractor emissions (Baker, et al., 2005; USDA-NRCS, 2006a). Surface residues and untilled 

organic matter physically hold the soil in place thus decreasing wind erosion of soils and 

pesticide drift in wind-eroded soils (Baker, et al., 2005; USDA-NRCS, 2006a). Reduced tillage 

also increases sequestration rates of potential carbon emissions from soils (Causarano, 

Franzluebbers, Reeves, & Shaw, 2006). 
DRAFT MONSANTO 87705 SOYBEAN 

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No Action: Air Quality and Climate Change 

Under the No Action Alternative, current impacts to air quality associated with land acreage and 

cultivation practices associated with soybean production would not be affected. 

Agronomic practices associated with conventional soybean production and current GE 

soybean varieties and which contribute to air quality and GHG emissions, including tillage, 

cultivation, irrigation, pesticide application, fertilizer applications and use of agriculture 

equipment, would not be expected to change. 

Preferred Alternative: Air Quality and Climate Change 

A determination of non-regulated status of MON 87705 Soybean will not change the cultivation 

or agronomic practices, or agricultural land acreage associated with growing soybean, and is 

expected to have the same effect on air quality and climate change as the No Action Alternative. 

Cumulative Effects: Air Quality and Climate Change

APHIS has not identified any cumulative effects for this issue. The use of MON 87705 Soybean

in commercial soybean production is not expected to cause any cumulative effect on air quality or 

climate change because APHIS does not anticipate any changes in soybean production practices 

or an expansion of soybean acreage as a result of a determination of nonregulated status of 

MON 87705 Soybean. The consequences of the Preferred Action Alternative on commercial 

soybean production and acreage are the same as for the No Action Alternative.

4.3 BIOLOGICAL RESOURCES 

4.3.1 Gene Movement and Weediness 

Two forms of gene flow are evaluated: Vertical gene flow and horizontal gene flow. Vertical 

gene flow, or hybridization and associated introgression, is the movement of genes to sexually 

compatible relatives (Ellstrand, 2003; Quist, 2010). The soybean is considered self-pollinating, 

and has no wild relatives in the U.S. (OECD, 2000; Rogan, 2010). Although some crosspollination can occur, AOSCA identity protection practices have been found adequate to protect 

against such gene flow (OECD, 2000; Rogan, 2010; USDA-APHIS, 2010a). The only relatives 

of soybean are other varieties currently cultivated. In assessing the risk of gene introgression 

from MON 87705 Soybean to its sexually compatible relatives, APHIS considered two primary 

issues: 1) the potential for gene flow and introgression to soybean relatives; and 2) the potential 

impact of introgression. Vertical gene flow is discussed below in the analysis of the Preferred 

Alternative. 

Horizontal gene flow represents the stable movement of genes from one organism to another 

without reproduction or human intervention (Keese, 2008; Quist, 2010). There is no evidence of 

naturally occurring transgene movement from transgenic crops to sexually incompatible species 

(Stewart, 2008). Horizontal gene transfer and consequent expression of DNA from one plant to 

another sexually incompatible plant or other phyla (e.g., species of bacteria) is unlikely to occur 

(Keese, 2008). This event would require physical relocation of the functional genetic sequences 

from the transgenic plant to the new location, including not only the genes which code for the 
DRAFT MONSANTO 87705 SOYBEAN 

 54 

production of specific proteins, but also those portions of the genome which regulate the activity 

of those genes (Keese, 2008; Stewart, 2008). There are no known naturally occurring vectors 

(such as plasmids, phages, or transposable elements) that could be responsible for inter-domain 

gene transfer, and there is little evidence that eukaryotic cells are naturally capable of stably 

incorporating genes from the environment into their genome (Brown, 2003). Although viruses 

do move genetic material, all viruses that infect higher plants have small RNA or DNA genomes, 

usually with fewer than 20 encoded proteins (Keese, 2008). These viruses are, therefore, 

constrained as to the type and size of novel genetic material which can be acquired by horizontal 

gene transfer (Stewart, 2008). The development of herbicide tolerance, particularly that 

experienced in crops treated with glyphosate, is thus not a result of gene transfer but is the result 

of selective pressures associated with herbicide use. This issue is discussed in the subsection on 

impacts to plant communities. 

Two bacteria species commonly associated with plants, Agrobacterium and Rhizobium, have 

been evaluated to determine the probability of horizontal gene transfer between the bacterium 

and their host plants. Agrobacterium moves its genes from its bacterial plasmid to the plant 

causing the plant to produce the gall; Rhizobium aids in nitrogen fixation in legume nodules 

(Stewart, 2008). The genomes of both bacteria have been sequenced, and the sequenced genes 

evaluated in search of exogenous genes (Kaneko, et al., 2000; Kaneko, et al., 2002; Wood, et al., 

2001). Despite what would appear to be millennia of symbiotic relationships between these 

bacteria and their host plants, there is no evidence that these organisms contain genes derived 

from plants (USDA-APHIS, 2010a). In cases where review of sequence data implied that 

horizontal gene transfer occurred, these events are inferred to occur on an evolutionary time 

scale of millions of years (Brown, 2003; Koonin, et al., 2001). Transgene DNA promoters and 

coding sequences are optimized for plant expression, not bacterial expression (USDA-APHIS, 

2010d). Horizontal gene flow, resulting in the relocation of entire transgenes including the 

regulatory portions of the DNA (those parts of the DNA which code for the production of the 

specific proteins in that relocated transgene) has never been shown to occur in nature (Clarke, 

2007; Stewart, 2008). Thus, even if horizontal gene transfer occurred, proteins associated with 

these transgenes are not likely to be produced in the new host organism (Stewart, 2008; USDAAPHIS, 2010a). Based on this information, APHIS considers the horizontal gene flow from 

MON 87705 Soybean or other cultivated GE soybean varieties to unrelated species to be 

unlikely. 

No Action: Gene Movement and Weediness 

Under the No Action Alternative, conventional and GE transgenic soybean production will 

continue to be grown commercially, while MON 87705 Soybean will remain a regulated article. 

Soybean cultivation practices are expected to remain the same. 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 Movement and Weediness 

APHIS evaluated the potential for gene introgression to occur from MON 87705 Soybean to 

sexually compatible varieties and considered the possibility that such introgression would result 

in increased weediness. Monsanto’s data found no significant difference in pollen morphology 
DRAFT MONSANTO 87705 SOYBEAN 

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and viability from field grown MON 87705 Soybean plants and other soybean varieties. The 

soybean is not identified as a weed in the U.S. (USDA-APHIS, 2010a). Soybeans are not frost 

tolerant, do not survive freezing temperatures, and do not reproduce vegetatively (OECD, 2000; 

USDA-APHIS, 2010a). 

Some research suggests that fatty acid composition may influence cold tolerance and 

survivability. Kodama (1994) and Kodama et al. (1995) have found that increases in levels of 

certain fatty acids, particularly hexadecatrienoic and linolenic acids, results in an increase in cold 

tolerance. In MON 87705 Soybean, the levels of linolenic acid are within the lower end of the 

commercial range of fatty acid composition when compared with other varieties (Rogan, 2010). 

Changes in oleic acid or linoleic acid composition and reductions in saturated fatty acids have 

not been linked to increased cold tolerance. The changes in fatty acid composition MON 87705 

Soybean are not expected to enhance cold tolerance (USDA-APHIS, 2010a). 

In its plant pest risk assessment, APHIS assessed the weediness potential of MON 87705 

Soybean based on the introduced EPSPS protein and the reductions in the FAD2 and FATB

genes controlling fatty acid composition (USDA-APHIS, 2010a). In each case, the changes 

introduced in the MON 87705 Soybean were deemed to not present a weediness risk (USDAAPHIS, 2010a). 

The change in composition of fatty acid in MON 87705 Soybean is due to the silencing of the 

endogenous FAD2 and FATB genes in the soybean. The suppression of these two genes is 

mediated by double-stranded RNA molecules and does not code for specific proteins. Double 

stranded RNAs are commonly used in plants for endogenous gene suppression and pose no novel 

risks from a plant pest perspective (USDA-APHIS, 2010a). The suppression of these two genes 

in MON 877805 is not anticipated to give rise to an enhanced weediness or gene flow. 

The only introduced gene in the MON 87705 Soybean is the cp4 epsps gene, which confers 

tolerance to the herbicide glyphosate. This gene is commonly found in other Roundup Ready®

crops (USDA-APHIS, 2010a). No data have been presented to suggest that the incorporation of 

the cp4 epsps gene allows soybean to survive and reproduce without human intervention 

(USDA-APHIS, 2010a). In its petition, Monsanto presented information on phenotypic and 

agronomic characteristics collected from field studies (Rogan, 2010). These data included 

information on seed dormancy, germination, emergence, seedling vigor, plant height, lodging, 

days to maturity, shattering, seed weight, yields, disease incidence, and insect damage, among 

others (Rogan, 2010). 

APHIS has assessed these data to evaluate the weediness potential of MON 87705 Soybean. 

Monsanto observed several statistically significant differences between MON 87705 Soybean 

and the control in: 

 early stand count; 

 final stand count; 

 days to 50% flowering; and 

 seed weight. 
DRAFT MONSANTO 87705 SOYBEAN 

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MON 87705 Soybean demonstrated lower early stand and final stand counts than those for 

controls (Rogan, 2010, pages 349-350, Table G-3, Appendix G). MON 87705 Soybean flowered 

about one day later than the control and the weight of 100 seeds was lower for MON 87705 

Soybean compared with the control (15.6 g vs. 16.1 g). In addition, MON 87705 Soybean had 

lower percent viable hard seed (0.0 vs. 0.3%) at 20°C, lower percent germinated seed at 30°C 

(92.8 vs. 95.5%), higher percent dead seed at 30°C (7.3 vs. 4.5%), and higher percent dead seed 

at 20/30oC (2.7 vs. 1.3%). A decrease in hard seed, a lower percent germinated seed and higher 

percent dead seed would not contribute to increased weediness. All values were well within the 

recommended standards for certified soybean seed (AOSCA, 2009). 

Results from the phenotypic and agronomic assessments indicate that MON 87705 Soybean does 

not possess characteristics that would confer a plant pest risk compared with conventional 

soybean (USDA-APHIS, 2010a). These data indicate that the engineered plant is not different in 

any fitness characteristics from its parent that are likely to cause the MON 87705 Soybean to 

become weedy or invasive (USDA-APHIS, 2010a). 

Based on the above information, APHIS has concluded that a determination of nonregulated 

status of MON 87705 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, 2010a). MON 87705 Soybean is expected to have the same effect on gene 

movement as the No Action Alternative.

Cumulative Effect: Gene Movement 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, transportation, and ginning 

procedures (Bradford, 2006; NCAT, 2003; Sundstrom, et al., 2002). As a specialty soybean 

variety, MON 87705 Soybean would be cultivated within these identity protection 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 87705 

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 of MON 87705 Soybean. 

4.3.2 Animals 

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. 

Invertebrates can feed on soybean plants or prey upon other insects living on soybean plants as 

well as in the vegetation surrounding soybean fields. The cumulative effects analysis for the 

potential effects of the production of MON 87705 Soybean on plants and animals is found below 

at “Cumulative Effects: Plants, Animals, Biodiversity.” 
DRAFT MONSANTO 87705 SOYBEAN 

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No Action: Animals 

Under the No Action Alternative, conventional and GE transgenic soybean production will 

continue while MON 87705 Soybean remains a regulated article. Potential impacts of GE and 

non-GE soybean production practices on non-target animals would be unchanged. 

Preferred Alternative: Animals 

Monsanto data indicate that the agronomic practices used to produce MON 87705 Soybean will 

be the same as those used to produce other conventionally grown GE and non-GE soybean. MON 

87705 Soybean production will neither change land acreage nor any cultivation practices for 

soybean production. 

To the extent that MON 87705 Soybean displaces conventional, non-GE soybean varieties, the 

expression of the CP4 EPSPS protein conferring tolerance to glyphosate may have an overall 

positive impact on animals. As previously discussed in the analysis of water and soil, in those 

fields where MON 87705 Soybean is cultivated, growers would be expected to take advantage of 

the weed control offered by glyphosate and continue to adopt conservation practices where 

appropriate. 

Agronomic practices used to produce MON 87705 Soybean will be the same as those used to 

produce other glyphosate-tolerant soybean, so any switch by growers from their current 

glyphosate-tolerant soybean to MON 87705 Soybean (which would also very likely express the 

glyphosate-tolerant trait) would not significantly change current practices or result in different or 

new impacts to animals associated with existing glyphosate-tolerant soybean cultivation. 

Animals are known to forage on soybean foliage and seed. With the exception of the 

introduction of the CP4 EPSPS protein conferring resistance to glyphosate, and the modifications 

to two endogenous genes to change fatty acid composition, no phenotypic or morphological 

differences have been identified between MON 87705 Soybean and conventional soybeans. 

The EPA has reviewed the safety of the CP4 EPSPS protein and has established a tolerance 

exemption for the protein and the genetic material necessary for its production in or on all raw 

agricultural commodities (US-EPA, 1996; 40 CFR §174.523). This exemption is based on a 

safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to 

known toxins and allergens, and lack of toxicity in an acute oral mouse gavage study. The lack 

of any documented reports of adverse effects since the introduction of other Roundup Ready®

crops in 1996 suggests the safety of its use. The CP4 EPSPS protein expressed in MON 87705 

Soybean is the same as that previously reviewed by the EPA; accordingly, MON 87705 Soybean 

and the incorporated cp4 epsps gene is expected to be safe for animal consumption. 

MON 87705 Soybean provides a modified fatty acid profile based on the suppression of two 

endogenous genes that are natural constituents of every soybean: FAD2 and FATB. Change in 

fatty acid composition resulting from the suppression of the FAD2 and FATB genes is not 

expected to cause impacts to animals consuming the soybean. MON 87705 Soybean contains 

only those fatty acids that are presently found in soybean oil. MON 87705 Soybean has a fatty 

acid profile that is comparable to commercial high oleic vegetable oils (e.g., high oleic canola, 
DRAFT MONSANTO 87705 SOYBEAN 

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high oleic safflower, high oleic sunflower), traditional oils such as olive oil that has a longhistory of consumption in the diet, and canola oil that obtained FDA GRAS (Generally 

Recognized as Safe) status. Table 4-1 presents a comparison of fatty acid profiles of several 

plant sources of vegetable oil, including conventional soybean and MON 87705 Soybean. 

Table 4-1: Comparison of Fatty Acid Profiles of MON 87705 Soybean with Several 

Other Plant Sources 

Oil 

% Saturated 

Fat1

% Oleic Acid1

(18:1) 2

% Linoleic 

Acid1 (18:2) 

% Linolenic 

Acid1 (18:3) % PUFAs1

Canola 6 57 26 10 32 

MON 87705 Soybean 6 76 10 7 17 

Conventional Soybean 15 23 53 8 60 

Olive 13 78 7 1 8 

Palm 50 38 11 1 12 

Coconut 92 6 2 0 2 

Notes: 

1. Percent fatty acid presented as a percent (%) of total fatty acids. 

2. Ratios presented within parenthesis represent the lipid numbers for the subject fatty acid, one of the more common 

nomenclature systems. The first number, e.g., 18, indicates the number of carbon atoms in the fatty acid, and the 

second number, e.g., 1, indicates the number of double bonds in the fatty acid. A fatty acid is considered saturated 

when there are no double bonds in the carbon chain, hence the 18:3 linoleic acid would be considered a polyunsaturated 

fatty acid, presenting three double bonds across the 18 carbons. 

Source: (Rogan, 2010, Table P-3) 

The potential risks to animals from the consumption of MON 87705 Soybean with a modified 

fatty acid composition also have been evaluated by the FDA (2011). Soybean meal is the most 

common supplemental protein source in U.S. livestock and poultry rations due to its nutrient 

composition, availability, and price (US-FDA, 2011). Although MON 87705 Soybean is 

intended to be cultivated as a specialty soybean to take advantage of the changed fatty acid 

composition, the soybean meal remaining after the extraction of the soybean oil may become a 

constituent of livestock or poultry food supplements. The FDA compared the composition of 

MON 87705 Soybean with the conventional non-transgenic soybean variety A3525, and also 

evaluated the potential impacts to animal diets from the reduced intake of linoleic acid (USFDA, 2011). Although the soybean meal derived from MON 87705 Soybean would have 

reduced levels of linoleic acid, the animal’s requirements for linoleic acid could be met by other 

ingredients in animal feed (US-FDA, 2011). 

Based on the above information, APHIS concludes that a determination of nonregulated status 

of MON 87705 Soybean is not expected to have adverse effects on non-target animals. 

4.3.3 Plants 

The landscape surrounding a soybean field 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. 

Cultural and mechanical weed control programs are important aspects of soybean cultivation 

(Aref & Pike, 1998; Byrd, et al., 2003; Duke & Powles, 2009; Loux, et al., 2008). In this 
DRAFT MONSANTO 87705 SOYBEAN 

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context, weeds are those plants which, when growing in the soybean field, compete with the 

soybean for space, water, nutrients and sunlight, and may thus include native species. The types 

of weeds in and around a soybean field will vary depending on the geographic region where 

the soybean is grown. 

No Action: Plants 

Plant species that typically inhabit soybean production systems will continue to be managed 

through the use of mechanical, cultural, and chemical control methods, including the use of 

glyphosate in those varieties already marketed as glyphosate-tolerant. No changes to 

cultivation practices are expected in the No Action Alternative. 

Preferred Alternative: Plants 

In the event of a determination of nonregulated status of MON 87705 Soybean, the risks to wild 

plants and agricultural productivity from weedy soybean populations are low; volunteer soybean 

populations are easily managed and there are no feral or weedy relatives. 

Agronomic studies conducted by Monsanto tested the hypothesis that the weediness potential of 

MON 87705 Soybean is unchanged with respect to conventional soybean (Rogan, 2010). No 

differences were detected between MON 87705 Soybean and nontransgenic soybean in growth, 

reproduction, or interactions with pests and diseases, other than the intended effect – changed 

fatty acid profile and glyphosate tolerance. Volunteer soybean is normally not a concern. 

Soybean is not winter hardy, and existing mechanical and chemical methods are available to 

manage the occasional volunteer soybean in cultivation areas (Carpenter, et al., 2002; OECD, 

2000). Several post-emergent herbicides are also widely used to control the presence volunteer 

soybeans in subsequent rotational crops (Zollinger, 2010). Based on these biological limitations, 

as well as readily available control practices, ta determination of nonregulated status of MON 

87705 Soybean is not likely to result in increased weediness. 

The availability of MON 87705 Soybean provides an additional glyphosate-tolerant option to 

soybean growers. Monsanto anticipates that MON 87705 Soybean will replace existing 

cultivated varieties of herbicide-tolerant soybean, and potentially other non-GE soybean 

varieties. The introduction and cultivation is not expected to change current herbicide use and 

methods for soybean production. Agricultural practices employed to manage glyphosateresistant weeds associated with currently deregulated glyphosate-tolerant soybeans will continue. 

These strategies include: 

 Developing a diversified weed management program using herbicides with different 

modes of action, either concurrently or sequentially (NRC, 2010). 

 Use the full recommended herbicide rate and proper application timing for the most 

difficult to control weeds in the field (NRC, 2010). 

 Scouting the fields after herbicide application to ensure that control has been achieved 

and to discourage weeds from reproducing or proliferating vegetatively (NRC, 2010). 

 Incorporate cultural practices such as cultivation, tillage and crop rotation, where 

appropriate (NRC, 2010). 
DRAFT MONSANTO 87705 SOYBEAN 

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To the extent that MON 87705 Soybean replaces a non-GE soybean variety, the cultivation of 

MON 87705 Soybean could lead to an increased use of glyphosate in those fields with the 

potential for development of glyphosate-resistant weeds over time. This potential impact is not 

limited to adoption of Mon 87705 Soybean, but would potentially arise in any field where a 

deregulated glyphosate-resistant crop is adopted to replace a non-GE variety. Overall impacts 

would be similar to the No Action Alternative. 

4.3.4 Microorganisms 

Microorganisms produce aromatic amino acids through the Shikimate pathway, similar to plants 

(USDA-FS, 2003). Because glyphosate inhibits this pathway, it could be expected that 

glyphosate would be toxic to microorganisms. However, field studies show that glyphosate has 

little effect on soil microorganisms, and, in some cases, field studies have shown an increase in 

microbial activity due to the presence of glyphosate (USDA-FS, 2003). 

Glyphosate use has been identified as potentially causing increases in certain disease-causing 

microbes (Fernandez, et al., 2009; Kremer, 2010). Reported increases in infections from 

pathogenic soil fungi have been determined to be more closely related to reduced tillage and 

continuous cropping using herbicide-tolerant crops, rather than application of glyphosate 

(Fernandez, et al., 2009). 

No Action: Microorganisms 

There would be no changes to current cultivation practices under the No Action Alternative. 

Microbes in the field would continue to be exposed to glyphosate and other herbicides. 

Preferred Alternative: Microorganisms 

Monsanto conducted field trials to assess potential agronomic differences between MON 87705 

Soybean and conventional soybean (variety A3525) (Rogan, 2010). These agronomic studies 

included analyses of differences in disease damage and inoculation of root nodules with 

symbiotic bacteria (Rogan, 2010). The disease analysis included observations of a wide range of 

bacterial and fungal pathogens, nematodes, and plant viruses (Rogan, 2010, see Table G-6). No 

significant differences in disease damage were noted between MON 87705 Soybean and the 

comparison control variety (Rogan, 2010). The lack of difference indicates that the expression 

of glyphosate tolerance and modified fatty acid content by MON 87705 Soybean does not 

change soybean interactions with microorganisms in the field. 

Monsanto also evaluated the potential impacts of these changes on the symbiotic relationship of 

soybean with the nitrogen-fixing root nodule bacteria Bradyrhizobium japonicum (Rogan, 2010). 

In these studies, Mon 87705 Soybean was compared with seven conventional soybean varieties 

(Rogan 2010, see Appendix I). No significant differences were detected between MON 87705 

Soybean and any of the comparison varieties for any of the measured parameters, including 

nodule number, root shoot total nitrogen (percent and mass), biomass of nodules, shoot material 

and root material (Rogan, 2010). These results indicate that the expression of glyphosate 
DRAFT MONSANTO 87705 SOYBEAN 

 61 

tolerance and the modified fatty acid composition is does not impact the inoculation of root 

nodules by the symbiotic bacteria. 

Consistent with these test results, the impacts of a determination of nonregulated status of MON 

87705 Soybean on microorganisms are the same as the No Action Alternative. 

4.3.5 Biodiversity 

Biodiversity in an agroecosystem depends on four primary characteristics: 1) diversity of 

vegetation within and around the agroecosystem; 2) permanence of various crops within the 

system; 3) intensity of management, including selection and use of insecticides and herbicides; 

and 4) extent of isolation of the agroecosystem from natural vegetation (Altieri, 1999; Palmer, et 

al., 2010). The reintroduction of woodlots, fencerows, hedgerows, wetlands, etc., has been used 

to enhance biodiversity in the agroecosystem landscape. Some enhancement strategies 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.), 

adoption of integrated pest management techniques, and the use of hedgerows and windbreaks 

(Altieri, 1999; Palmer, et al., 2010). The adoption of GE crops, with the concomitant reduction 

in insecticide use and enhanced soil conservation practices, has also contributed to the increase 

in biodiversity of soil microorganisms, beneficial organisms, and plants (Dively & Rose, 2003; 

Naranjo, 2009a; Palmer, et al., 2010; Sanvido, Stark, Romeis, & Bigler, 2006). 

No Action: Biological Diversity 

Under the No Action Alternative, MON 87705 Soybean would continue to be regulated articles. 

Growers and other parties who are involved in production, handling, processing, or consumption 

of soybean would continue to have access to existing deregulated GE soybean varieties, 

herbicide-tolerant soybean varieties, and conventional soybean varieties. The implications of 

agronomic practices associated with soybean production whether traditional or GE varieties with 

the attendant effects on biodiversity would not change. 

Preferred Alternative: Biological Diversity 

The use of genetically modified soybean such as MON 87705 Soybean affects biological 

diversity by providing the opportunity to use conservation practices that enhance habitat 

creation; which in turn, presents opportunities to positively benefit the floral and faunal 

communities that can potentially inhabit the fields and immediate surroundings. Incorporation of 

herbicide tolerance in the crop facilitates the grower adoption of no-till, crop rotation, and 

contour strip cropping, each of which contributes to the health of the faunal and floral 

communities in and around soybean fields thereby promoting biodiversity (Palmer, et al., 2010; 

Sharpe, 2010). 

The cultivation of MON 87705 Soybean would not change the use of insecticides to manage the 

invertebrate pests of soybean. Practices currently employed for the management of conventional 

and other GE soybean would likely continue for this crop. In this regard, a determination of 
DRAFT MONSANTO 87705 SOYBEAN 

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nonregulated status of MON 87705 Soybean would have the same impacts on biodiversity as the 

No Action Alternative. 

Although soybean fields are cultivated as monocultures to optimize soybean yield, the landscape 

adjacent a soybean field may harbor a wide variety of plants. Broad spectrum herbicide 

application has the potential to impact off-site plant communities. MON 87705 Soybean allows 

growers to continue to use glyphosate for post-emergent weed control. The Roundup Ready®

soybean system has become the standard weed control program in the U.S. cultivation of 

soybean. Approximately 92% of the U.S. soybean acreage is planted in Roundup Ready®

soybean varieties. Monsanto anticipates that MON 87705 Soybean will replace glyphosatetolerant soybean varieties previously deregulated pursuant to Part 340 and the Plant Protection 

Act. Accordingly, the cultivation of MON 87705 Soybean is not expected to result in an 

increase in the application of glyphosate or changes in herbicide treatments when compared with 

existing deregulated glyphosate-tolerant soybean varieties. 

The emergence of glyphosate-resistant weed species has been well documented, and presents a 

challenge to all growers using glyphosate-tolerant crops (Benbrook, 2009). In these cases, 

growers must also utilize other herbicides and tillage practices for weed management. 

Agricultural practices employed to manage glyphosate-resistant weeds associated with currently 

deregulated glyphosate-tolerant soybeans will continue. These strategies include: 

 Developing a diversified weed management program using herbicides with different 

modes of action, either concurrently or sequentially (NRC, 2010). 

 Use the full recommended herbicide rate and proper application timing for the most 

difficult to control weeds in the field (NRC, 2010). 

 Scouting the fields after herbicide application to ensure that control has been achieved 

and to discourage weeds from reproducing or proliferating vegetatively (NRC, 2010). 

 Incorporate cultural practices such as cultivation, tillage and crop rotation, where 

appropriate (NRC, 2010). 

In this regard, a determination of nonregulated status of MON 87705 Soybean would present the 

same impact to biodiversity as other currently deregulated Roundup Ready® soybean varieties. 

The effect of soybean production on plant communities is likely to be unchanged by the 

introduction of MON 87705 Soybean. 

A determination of nonregulated status of MON 87705 Soybean will not change the cultivation 

or agronomic practices, or agricultural land acreage associated with growing soybean. MON 

87705 Soybean would be an additional glyphosate-tolerant variety. The change in fatty acid 

composition expressed in MON 87705 Soybean is consistent with existing oil crops and within 

general nutritional profiles. 

Therefore, a determination of nonregulated status of MON 87705 Soybean is highly unlikely to 

have any direct toxic effects on non-target organisms and is likely to be neutral or beneficial to 

animal and plant biodiversity. 
DRAFT MONSANTO 87705 SOYBEAN 

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Cumulative Effects: Animals, Plants, and 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 87705 Soybean is planted. 

Based on available scientific data, the changes in fatty acid composition associated with MON 

87705 Soybean are not expected to directly or indirectly affect plants, animals or biodiversity. 

The genes responsible for the change in fatty acid composition are endogenous to the soybean 

and are thus already a part of the soybean cultivation environment. The EPA has reviewed the 

safety of the CP4 EPSPS protein and has established a tolerance exemption for the protein and 

the genetic material necessary for its production in or on all raw agricultural commodities (USEPA, 1996; 40 CFR§174.523). The lack of any documented reports of adverse effects since 

the introduction of other Roundup Ready® crops in 1996 suggests the safety of its use. The 

CP4 EPSPS protein expressed in MON 87705 Soybean is the same as that previously reviewed 

by the EPA, accordingly, MON 87705 Soybean is anticipated to be safe for animal consumption 

with regard to the cp4 epsps gene. 

Cultivation of MON 87705 Soybean is highly unlikely to have direct toxic effects on non-target 

organisms and is likely to be neutral to biodiversity compared with conventionally managed GE 

and non-GE soybean. Therefore, the likelihood of adverse cumulative effects on non-target 

organisms and biodiversity following the introduction of MON 87705 Soybean is minimal. 

4.4 PUBLIC HEALTH 

4.4.1 Worker Safety 

EPA’s Worker Protection Standard (WPS) (40 CFR Part 170) was published in 1992 to require 

actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and 

pesticide handlers. The WPS offers protections to more than two and a half million agricultural 

workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, 

and greenhouses. The WPS contains requirements for pesticide safety training, notification of 

pesticide applications, use of personal protective equipment, restricted entry intervals following 

pesticide application, decontamination supplies, and emergency medical assistance. 

No Action: Worker Safety 

During agricultural production of soybean, agricultural workers and pesticide applicators may 

be exposed to a variety of EPA registered pesticides (see, e.g., 

http://www.cdc.gov/niosh/topics/pesticides/). Such chemicals would be expected to include 

those products currently used for insect pest and plant pest management in both GE and non-GE 

soybean cultivation. Worker safety is taken into consideration when a pesticide label is 

developed during the registration process. When used consistent with the label, pesticides 

present minimal risk to the worker. No changes to current worker safety are anticipated under 

the No Action Alternative. 
DRAFT MONSANTO 87705 SOYBEAN 

 64 

Preferred Alternative: Worker Safety 

If MON 87705 Soybean is adopted, agricultural workers and pesticide applicators will continue 

to be exposed to glyphosate. As MON 87705 Soybean does not require different cultivation 

practices than currently available glyphosate-tolerant soybean, this level of herbicide exposure is 

expected to be the same as the No Action Alternative. 

The introduction of novel proteins to a crop carries the risk of potential allergenicity. The only 

introduced protein in MON 87705 Soybean is the CP4 EPSPS protein derived from 

Agrobacterium sp. The changed fatty acid composition is a result in suppression of two 

endogenous soybean genes and not the introduction of new genes or proteins (Rogan, 2010). 

The CP4 EPSPS protein is not known to present any potential allergenicity. FDA’s consultation 

on MON 87705 Soybean found no evidence of potential allergenicity of the MON 87705 

Soybean (US-FDA, 2011). 

The EPA has reviewed the safety of the CP4 EPSPS protein and has established a tolerance 

exemption for the protein and the genetic material necessary for its production in or on all raw 

agricultural commodities (US-EPA, 1996; 40 CFR §174.523). This exemption is based on a 

safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to 

known toxins and allergens, and lack of toxicity in an acute oral mouse gavage study. The lack 

of any documented reports of adverse effects since the introduction of other Roundup Ready®

crops in 1996 suggests the safety of its use.

The CP4 EPSPS protein expressed in MON 87705 Soybean is the same protein previously 

reviewed by the EPA. Accordingly, worker safety risk associated with cultivation of and 

exposure to MON 87705 Soybean is the same as the No Action Alternative. 

Cumulative Effects: Worker Safety 

MON 87705 Soybean is not expected to increase the total acreage of soybean production or the 

use of GE soybean. Monsanto anticipates that MON 87705 Soybean will primarily replace some 

of the herbicide-tolerant soybean cultivars already on the market today as its nutritional values 

are adopted in the market. As a result, worker safety issues related to the use of EPA registered 

pesticides during conventional and GM soybean production should remain the same. However, 

if a grower replaces a non-herbicide-tolerant soybean variety with MON 87705 Soybean it would 

be expected that there would be a corresponding change in the use of post-emergent herbicides. 

This has been the case with the adoption of other GM soybean cultivars (Benbrook, 2009). To 

the extent that such changes result in the replacement of more toxic herbicides with glyphosate, 

the change should positively benefit worker safety. 

4.4.2 Human Health

Under Federal Food Drug and Cosmetic Act, 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 MON 87705 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. 
DRAFT MONSANTO 87705 SOYBEAN 

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With regard to human health effects, the FDA reviews assess the relative toxicity of the 

incorporated proteins on humans from the perspective of both consumption as well as exposure. 

Monsanto has submitted a food and feed safety and nutritional assessment to the FDA for 

this product. The FDA has completed their consultation on MON 87705 Soybean, a copy of 

which is provided in Appendix A (US-FDA, 2011). 

No Action: Human Health 

Under the No Action Alternative, MON 87705 Soybean would continue as a regulated article. 

Human exposure to existing traditional and GE soybean would not change under this alternative. 

Growers and consumers exposure to this product would be limited to those individuals involved 

in the cultivation of MON 87705 Soybean under regulated conditions. 

During agricultural production of soybean, people other than agricultural workers may be 

exposed to a variety of EPA registered pesticides (see, e.g., 

http://www.cdc.gov/niosh/topics/pesticides/). Such chemicals would be expected to include 

those products currently used for insect pest and plant pest management in both GE and non-GE 

soybean cultivation. Human health and safety is taken into consideration when a pesticide label 

is developed during the registration process. When used consistent with the label, pesticides 

present minimal risk. No changes to human health are anticipated under the No Action 

Alternative. 

Preferred Alternative: Human Health 

APHIS considers the FDA regulatory assessment in making its determination of the 

potential impacts of deregulation of the new agricultural product. The FDA has completed 

its consultation on MON 87705 Soybean, and has concluded that the product is not 

materially different in any respect relevant to food safety compared to soybean varieties 

currently on the market (US-FDA, 2011). The FDA’s conclusions are based on an 

evaluation of the introduced protein, CP4 EPSPS, as well as the changes in the expression of 

the two endogenous genes resulting in modified fatty acid content. 

Similar products have been previously deregulated pursuant to Part 340 and the Plant Protection 

Act for general cultivation beginning in the mid-1990s with the introduction of Roundup Ready®

products providing tolerance to glyphosate with the introduction of the cp4 epsps gene. In each 

case, FDA and EPA reviews and approvals determined that the products met the agency’s review 

criteria for approval. The cultivation of these existing crop products would not change under 

either alternative. Both characteristics have been successfully cultivated in multiple crops in the 

ensuing years with no evidence of human health impacts. 

The CP4 EPSPS protein confers tolerance to glyphosate. This protein is structurally homologous 

and similar functionally to endogenous plant EPSPS enzymes and is identical to the CP4 EPSPSs 

in other Roundup Ready® crops, including Roundup Ready® soybean (40-3-2 and MON 89788, 

Roundup Ready® canola, Roundup Ready® sugar beet, Roundup Ready® flax, and Roundup 

Ready® cotton (USDA-APHIS, 2010a). The first generation of Roundup Ready® soybean (40-3-

2) was deregulated in 1995 (USDA-APHIS, 2010a). The cp4 epsps gene has been assessed 

extensively in the last 15 years. The safety of CP4 EPSPS protein present in biotechnology 
DRAFT MONSANTO 87705 SOYBEAN 

 66 

derived crops has been evaluated as part of comprehensive reviews of the safety of glyphosate 

exposure and ingestion (Harrison et al., 1996; see also Hammond et al., 1996; Padgette et al., 

1996). The FDA has reviewed the safety of human consumption of the CP4 EPSPS protein in 

MON 87705 Soybean, and concluded that this protein presents negligible risk to human health 

from consumption (US-FDA, 2011). 

The EPA has also reviewed the safety of the CP4 EPSPS protein and has established a tolerance 

exemption for the protein and the genetic material necessary for its production in or on all raw 

agricultural commodities (US-EPA, 1996; 40 CFR §174.523). This exemption is based on a 

safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to 

known toxins and allergens, and lack of toxicity in an acute oral mouse gavage study. The CP4 

EPSPS protein expressed in MON 87705 Soybean is the same as that previously reviewed by the 

EPA. Accordingly, MON 87705 Soybean is anticipated to be safe for human and animal 

consumption with regard to the cp4 epsps gene. 

APHIS has considered the human health impacts associated with the modified fatty acid profile 

based on the suppression of two naturally occurring, endogenous soybean genes: FAD2 and 

FATB. Monsanto’s intention in developing MON 87705 Soybean is the development of a fatty 

acid profile which provides nutritional benefits by presenting a healthier composition of 

saturated and unsaturated fats, as well as improved oil stability. Monsanto presents data 

comparing the fatty acid and other nutritional element concentrations with the reported ranges 

for conventional soybean and against commercial tolerance ranges (see, e.g., Rogan, 2010 Table 

VII-1, page 96). In addition to evaluating the targeted fatty acid composition, Monsanto 

evaluated non-fatty acid nutrients, anti-nutrients, proximate and fiber levels, consistent with the 

compositional guidance provided by the OECD (2001). Table 4-2 presents a summary of 

Monsanto’s reported change in fatty acid composition for MON 87705 Soybean compared with 

conventional soybean and commercial tolerance limits: 

Table 4-2: Comparison of Targeted Fatty Acid Levels in MON 87705 Soybean with 

Conventional Soybean Control (A3525) and Commercial Tolerance Intervals

Fatty Acid (% 

Total) 

MON 87705 Soybean 

Mean 

[Range] 

Conventional Soybean 

Mean 

[Range] 

Commercial Tolerance 

Interval 

16:0 Palmitic 2.36 

[2.25 – 2.44] 

10.83 

[10.51 - 11.08] 

7.62 – 12.55 

18:0 Stearic 3.31 

[3.07 – 3.82] 

4.50 

[4.24 – 4.85] 

2.87 – 7.15 

18:1 Oleic 76.47 

[73.13 – 79.17] 

22.81 

[21.41 – 25.08] 

18.40 – 30.22 

18:2 Linoleic 10.10 

[7.85 – 12.42] 

52.86 

[51.68 – 53.89] 

47.75 – 56.76 

Source: (Rogan, 2010 Table VII-1, page 97). 

Total saturated fat (as measured by palmitic and stearic acid percentages) was decreased from 

15.3% in the conventional soybean to 5.7% in MON 87705 Soybean. The mean level of oleic 

acid increased from 22.81% in the conventional soybean to over 76.47% in MON 87705 

Soybean. There was a corresponding decrease in linoleic acid as well, with MON 87705 

Soybean concentrations of 10.10% when compared to the conventional variety at 52.86%. This 
DRAFT MONSANTO 87705 SOYBEAN 

 67 

fatty acid profile is more heart healthy than conventional soy oil, and the changes from the 

conventional oil composition are within dietary guidelines for fat intake (Lichtenstein et al., 

2006; Rogan, 2010). 

MON 87705 Soybean contains only those fatty acids that are presently found in soybean oil. 

MON 87705 Soybean has a fatty acid profile that is comparable to commercial high oleic 

vegetable oils (e.g., high oleic canola, high oleic safflower, high oleic sunflower), traditional oils 

such as olive oil that has a long-history of consumption in the diet, and canola oil that obtained 

FDA GRAS status. Table 4-1 (see Subsection 4.4.2) presented a comparison of fatty acid 

profiles of several plant sources of vegetable oil, including conventional soybean and MON 

87705 Soybean. 

Monsanto also evaluated other compositional aspects of MON 87705 Soybean and compared 

these data with conventional soybean composition. Differences were observed in the 

concentrations of three other fatty acids (18:3 linolenic acid, 20:0 arachidic acid and 20:1 

eicosenoic acid), total fat, and two amino acids (arginine and cysteine) (Rogan, 2010). APHIS 

has evaluated the differences reported in these compositional elements, and has determined that 

the reported differences are within the 99% tolerance interval for soybean composition (Rogan, 

2010, Table E-13, page 303). The FDA consultation on MON 87705 Soybean evaluated this 

same data, and have concluded that the consumption of MON 87705 Soybean is not materially 

different from other soybean varieties currently on the market (US-FDA, 2011). 

Monsanto’s petition presents a nutritional impact evaluation (Rogan, 2010, Appendix M). In this 

assessment, Monsanto presents the output of a dietary replacement model, in which it is assumed 

that 100% of the liquid soybean oil in the marketplace is replaced with MON 87705 Soybean oil. 

Products assumed to be consumed included salad dressings, mayonnaise and solid spreads, home 

use soybean oil, and margarines (Rogan, 2010). Fry oils were not included in Monsanto’s 

analysis. APHIS has reviewed the outputs of the dietary model presented by Monsanto. The 

replacement of conventional soy oil with MON 87705 Soybean oil does not change total daily fat 

intake. Total oleic acid consumption increased, as would be expected by the changes in oil 

composition. Although the consumption of monounsaturated fatty acids are not required in the 

diet, they do contribute to achieving total fat intake recommendations (USHHS, 2005). 

Monsanto notes that substitution of oleic acid for saturated fat in the diet can reduce low density 

lipoprotein cholesterol (Rogan, 2010). The dietary replacement model output, when compared 

with recommended dietary intake values, suggests that soybean oil based on MON 87705 

Soybean is safe for human consumption at a 100% replacement. Other than corresponding 

differences in fatty acid composition, no differences in human health impacts are anticipated 

between the No Action and the Preferred Alternative. 

In addition to its submittal to the FDA, Monsanto has also submitted applications to several 

international organizations for the MON 87705 Soybean. The current status of these applications 

is reported as follows (as of January 2011): 

 Canadian Food Inspection Agency is currently reviewing Monsanto’s application. The 

public comment period closed on March 26, 2010. 

 The Australia New Zealand Food Safety Agency tabled further consideration of 

Monsanto’s application on July 23, 2010, pending receipt of additional information from 
DRAFT MONSANTO 87705 SOYBEAN 

 68 

Monsanto and the completion of a comprehensive pre-market safety analysis. 

 An application was presented to the European Union (EU) (Monsanto, 2011). Several 

EU member agencies have then reported on this application. 

o The Commissie Genetische Modificatie (COGEM) has approved the importing 

and processing of the product (COGEM, 2010). COGEM’s approval does not 

provide any analysis of food safety issues. 

o The European Food Safety Agency (EFSA) notes that Monsanto’s application 

was received and reviewed in August, 2010. EFSA has asked Monsanto for 

additional information: 

(http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=

EFSA-Q-2010-00165). 

o The Norway Center for Biological Safety (GENOK) identifies what it classifies as 

data deficiencies relative to food safety presented in Monsanto’s application 

(GENOK, 2010). 

APHIS acknowledges that several of these international agencies seek additional information 

from Monsanto in order to complete their review. APHIS is not familiar with the applications 

submitted by Monsanto to these agencies and cannot independently assess the quality of the data 

provided or the context of these various agency reviews. 

Based on the FDA’s consultation (US-FDA, 2011), our analysis of field and laboratory data and 

scientific literature provided by Monsanto (Rogan, 2010), and safety data available on other GE 

soybean, APHIS has concluded that under this alternative, a determination of nonregulated status 

of MON 87705 Soybean would have no significant impacts on human health. Overall human 

health impacts associated with cultivation are similar to the No Action Alternative. 

The Preferred Alternative impacts to human health differ from the No Action Alternative with 

regard to potential human health benefits associated with consumption of the oil from this crop. 

The FDA analysis (US-FDA, 2011) and Monsanto’s data (Rogan, 2010) suggest that replacing 

food oils with the soybean oil extracted from the MON 87705 Soybean may have a positive 

impact on human health in those cases where the replaced oil is a polyunsaturated product. The 

reduction in levels of polyunsaturated fatty acids in the MON 87705 Soybean oil is considered 

heart healthy. The extent to which this positive benefit may be observed is contingent upon the 

market share of the MON 87705 Soybean and the types of food products adapting the modified 

oil product. 

Cumulative Effects: Human Health 

There are no significant impacts on human health related to the No Action Alternative or a 

determination of nonregulated status of MON 87705 Soybean. Moreover no cumulative 

effects have been identified.

4.5 ANIMAL FEED 

The majority of the soybean cultivated in the U.S. is grown for animal feed, and is usually 

fed as soybean meal (Rogan, 2010). Soybeans intended for animal feed are generally 

cultivated as commodity products, although there are some consumers demanding specific 
DRAFT MONSANTO 87705 SOYBEAN 

 69 

physical or chemical characteristics to meet specific feed needs (Rogan, 2010). In these 

cases, the soybean meeting those specialized needs are cultivated as a specialty soybean 

crop. The cultivation practices necessary to maintain identity protection have been 

previously discussed in Subsection 2.2.4 above. 

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 87705 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 87705 Soybean, a copy of which is 

presented in Appendix A (US-FDA, 2011). 

No Action: Animal Feed 

Under the No Action Alternative, soybean-based animal feed will still be available from 

currently cultivated soybean varieties, both conventional varieties as well as deregulated GE 

soybean expressing herbicide tolerance. No change in the availability of these crops as animal 

feed is expected under the No Action Alternative. 

Under the No-Action Alternative, MON 87705 Soybean will remain a regulated product. There 

have been instances where growers involved in field trials of regulated products have been 

authorized to introduce the regulated product into animal feed for local consumption. As 

discussed in more detail below, the FDA has reviewed the characteristics and composition of 

MON 87705 Soybean and has not identified any differences between it and other soybean 

varieties. Consistent with these findings, if MON 87705 Soybean is introduced into animal feed 

while still a regulated article, no impacts to animal health are expected. 

Preferred Alternative: Animal Feed 

The FDA has completed its consultation on the MON 87705 Soybean (US-FDA, 2011). Based 

on a review of composition and nutritional characteristics of MON 87705 Soybean, the FDA has 

concluded that MON 87705 Soybean is not materially different in any respect relevant to feed 

safety compared to soybean varieties already on the market (US-FDA, 2011). 

Monsanto has submitted compositional and nutritional characteristics of MON 87705 Soybean to 

APHIS (Rogan, 2010). As part of field trials, samples of MON 87705 Soybean and conventional 

variety A3525 were collected from five different field trial locations during the 2007-2008 

growing season (Rogan, 2010). These samples were analyzed for comparable nutritional 

components, including proximate (protein, fat, carbohydrates, fiber, ash, moisture), vitamins, 

amino acids, fatty acids, and the antinutrient factors of soybean (which included lectin, trypsin 

inhibitors, isoflavones, and phytic acid) (Rogan, 2010). APHIS has reviewed Monsanto’s results 

and has concluded that with the exception of the changes in fatty acid composition, the levels of 

nutrients, anti-nutrients, and secondary metabolites in MON 87705 Soybean are not statistically 

different from those found in the conventional variety. 

The change in fatty acid composition is not expected to impact the value of MON 87705 

Soybean as an animal feed. The total fat content of the oil is unchanged. To the extent that 
DRAFT MONSANTO 87705 SOYBEAN 

 70 

consumers desire an animal feed providing elevated concentrations of oleic acid, with 

corresponding decreased concentrations of palmitic and linoleic acids, MON 87705 Soybean 

contains only those fatty acids that are presently found in soybean oil. MON 87705 Soybean 

has a fatty acid profile that is comparable to commercially available high oleic vegetable oils 

(e.g., high oleic canola, high oleic safflower, high oleic sunflower), traditional oils such as 

olive oil that has a long-history of consumption in the diet, and canola oil that obtained FDA 

GRAS status. As MON 87705 Soybean is intended to be cultivated as a specialty soybean, 

APHIS anticipates that consumers would not purchase this crop without understanding and 

desiring the changed fatty acid profile. To the extent that soybean meal derived from MON 

87705 Soybean is used as animal feed, and the user requires a higher concentration of linoleic 

acid, other sources of linoleic acid could be readily provided (e.g., corn) (US-FDA, 2011). 

MON 87705 Soybean expresses the CP4 EPSPS protein, derived from Agrobacterium sp., to 

achieve glyphosate herbicide tolerance. The EPA has reviewed the safety of the CP4 EPSPS 

protein and has established a tolerance exemption for the protein and the genetic material 

necessary for its production in or on all raw agricultural commodities (US-EPA, 1996; 40 

CFR §174.523). This exemption is based on a safety assessment that included rapid digestion 

in simulated gastric fluids, lack of homology to known toxins and allergens, and lack of 

toxicity in an acute oral mouse gavage study. The lack of any documented reports of adverse 

effects since the introduction of other Roundup Ready® crops in 1996 suggests the safety of 

its use. 

Based on this information APHIS has concluded that a determination of nonregulated status of 

MON 87705 Soybean would have no significant impacts on animal feed or animal health. 

Overall impacts are similar to the No Action Alternative.

Cumulative Effects: Animal Feed 

There are no significant impacts on animal health related to the No Action Alternative or a 

determination of nonregulated status of MON 87705 Soybean; and no cumulative effects have 

been identified. 

4.6 SOCIOECONOMIC ISSUES 

4.6.1 Domestic Economic Environment at Risk 

Herbicide tolerant soybean is cultivated on 93% of the U.S. soybean acreage (USDA-ERS, 

2010a, 2010b). The U.S. acreage of soybeans planted has varied over time, but the USDA has 

noted that the acreage dedicated to soybean has declined in recent years as returns on investment 

favored corn production (USDA-ERS, 2008). Although acreage has declined, the yield per acre 

has continued to increase (USDA-ERS, 2008). Short-season varieties have provided northern 

growers with the option to replace wheat crops with soybeans (USDA-ERS, 2008). 

Soybean oil lost market share in the food industry early in the decade as consumers sought 

vegetable oils that were lower in trans-fatty acids; this trend has slowed with the availability of 

low-linolenic and high-oleic varieties of soybean (USDA-ERS, 2008). The decline in food uses 
DRAFT MONSANTO 87705 SOYBEAN 

 71 

was replaced by an increase in demand for commodity-grade soy oil for biodiesel production 

(USDA-ERS, 2008). 

No Action: Domestic Economic Environment 

Under the No Action Alternative, MON 87705 Soybean and its progeny would continue to be 

regulated under 7 CFR Part 340. Growers and other parties who are involved in production, 

handling, processing, or consumption of soybean would not have access to MON 87705 Soybean 

and its progeny, but would continue to have access to GE herbicide tolerant soybean varieties 

previously deregulated pursuant to Part 340 and the Plant Protection Act as well as conventional 

varieties. Domestic growers will continue to utilize currently available traditional and GE 

soybean varieties based upon availability and market demand. 

Preferred Alternative: Domestic Economic Environment 

Monsanto anticipates that MON 87705 Soybean and its progeny would replace currently 

available herbicide-tolerant soybean varieties and would be cultivated as a specialty crop to 

preserve the desired characteristics continuing on to the ultimate consumer (Rogan, 2010). 

Monsanto does not anticipate that MON 87705 Soybean would change soybean production 

practices or increase soybean acreage (Rogan, 2010). APHIS concurs that properties of 

MON87705 are not different enough from commodity oil to require additional acreage for new 

soybean varieties or to initiate substantially new uses. Existing soybean users will either change 

their expectations for soy oils to those expressed by this variety, or remain users of commodity 

soy oil. 

Stewardship of MON 87705 Soybean. Soybean oil users who may have concerns about 

undesirable changes in standard properties of this modified oil have been identified by 

Monsanto, and dialogues have begun to solicit both specific issues of importance and to provide 

these stakeholders with relevant information (Rogan, 2010, Addendum 1). As noted in 

Addendum 1 to the MON 87705 petition, these groups include trade organizations representing 

oil processors, elevators, grain and oilseed processors, agricultural businesses and exporters, 

bakers, and grocery producers. Issues of commingling have been addressed in Addendum 1 (see 

for example, impacts on international specifications for commodity soybean oil, and allowable 

changes in nutrition facts labeling). Increasing quantities of commingled MON 87705 with 

commodity oil has been shown to increase the oil stability index, which would benefit those oil 

applications involving severe heat processing. Commingling of MON 87705 up to 15% content 

in the commodity oil had no impact on flavor of French fries (Figure 6, Appendix 3). 

Management plans for MON 87705 soybean have been designed for production integrity at all 

steps of seed production, including field production by the grower and on farm storage, grain 

elevators, oil and meal processors, and food companies as well as product identity and 

assessment (Addendum 1, Rogan, 2010). Contract buyers of MON 87705 will have Near 

Infrared Transmittance equipment provided them, for identifying 87705 soybean at grain 

elevators, and sampling for 87705 grain will be required by contract for each arriving truckload. 

Processors will use gas chromatography to provide oil constituent analysis. In addition to 

contracts and agreements with Monsanto, product identity at all steps will be additionally 

maintained by dedication of soybean sellers and oil processors to capture premium prices. With 
DRAFT MONSANTO 87705 SOYBEAN 

 72 

this as a goal, the soybean industry will observe best management practices, use appropriate 

identification procedures and proprietary inventory systems and ensure traceability requirements. 

Through these proposed measures, which would be established by contractual agreements with 

growers, elevators and processors, Monsanto aims to provide stewardship during all phases of 

production for stakeholders invested in uses of soybean oil. 

Monsanto characterizes the vegetable oil industry as highly adept at handling multiple crop 

species and the oils extracted from them (Addendum 1). Oil processors and users are able to 

appropriately characterize, segregate and blend for special functions the identity preserved oils 

available to them for attaining the final quality needed in specialty products. The Monsanto 

Vistive low-linolenic variety has been available to oil users for six years, and is grown on over 3 

million acres (Petition Addendum1). The identity preserved production plan for current Vistive 

low linolenic oil is similar to the plan described here for MON 87705 soybean oil and thus 

provides Monsanto with relevant experience in establishing and maintaining IP soybean 

processes. 

Market Share/Uses of MON 87705 Soybean. The majority of soybean cultivated in the U.S. is 

grown as a commodity product intended for animal feed. Specific market uses for specialty 

soybean products generally require adherence to specialty crop practices to preserve identify 

from seed production through harvesting, handling, and processing. A premium is paid to 

growers and processors for delivering product that meets these desired purity and quality 

standards (Elbehri, 2007; Lee & Herbek, 2004; Muth, et al., 2003; Pritchett, et al., 2002; Smyth 

& Phillips, 2002; Sundstrom, et al., 2002). MON 87705 Soybean is considered a specialty 

soybean product and will be marketed in accordance with other high-value specialty crop 

products (Rogan, 2010). To maintain the IDP for the product, growers cultivating MON 87705 

Soybean may potentially incur increased costs for production and distribution throughout the 

supply chain (mostly IDP costs). The extent to which MON 87705 Soybean displaces other 

cultivated varieties cannot be predicted, as market segment is contingent on variety acceptance 

by both growers and consumers. 

Monsanto has developed MON 87705 Soybean to improve soybean oil’s oxidative stability 

profile without the need for hydrogenation, and to lower the saturated fat content of the oil 

(Rogan, 2010). Both characteristics are perceived as providing added value to the variety. The 

changes in fatty acid composition are perceived to potentially expand the food market 

applications of soy oil with a heart healthy product. The modified oil is also a candidate source 

for industrial and biofuel products. 

An analysis of introduction of a high oleic soybean variety by economists demonstrates the 

potential for increasing the market share of the high oleic variety relative to that of commodity 

soybean oil Giannakas and Yiannaka, 2010). The main variables that determine outcomes will 

be consumer acceptance (including that of food and industrial producers) and price of the 

commodity Giannakas and Yiannaka, 2010). The greatest impacts will occur if the price of the 

novel soybean oil is relatively low, and consumer evaluation is highly favorable, which could 

result in the modified fatty acid product driving conventional soybean from the market. In this 

event, increased economic benefit would ensue to producers of the novel oil. Because these 

variables associated with MON 87705 soybean cannot be determined at present, no definitive 

conclusions can be made about market share impacts on soybean oil producers. 
DRAFT MONSANTO 87705 SOYBEAN 

 73 

Potential Market Response to MON 87705 Soybean. Changes in total acreage of specific crop 

varieties in response to market demand can be readily observed. In 1995, the National 

Sunflower Association began developing sunflower varieties to take advantage of pending label 

requirements for trans fatty acids (NSA, 2006). By 2005, it was estimated that 80% of the U.S. 

sunflower acreage was planted in NuSunTM, a conventionally produced high-oleic variety (NSA, 

2006). This transition occurred after the food industry conducted extensive studies of food 

chemistry, supported by human health assessments (NSA, 2006). 

An increase in the percentage of acreage dedicated to MON 87705 Soybean is contingent on 

satisfying specific industry standards as well as its ability to compete with other modified fatty 

acid soybean products. After the 2006 FDA trans fat labeling requirement, soybean lost market 

share to palm and certain canola oils (Waltz, 2010). MON 87705 Soybean is one of several 

soybean varieties developed in the attempt to recapture soybean’s market share for food oil 

(Waltz, 2010). MON 87705 Soybean will compete in the market with other modified fatty acid 

soybeans, conventional and GE, including Pioneer’s “Plenish high-oleic soybean” (Waltz, 2010). 

The industry acceptance and ultimate success of each variety is contingent on MON 87705 

Soybean satisfying consumer taste tests, frying tests, and shelf-life tests similar to those 

demonstrated by high-oleic sunflower oil (NSA, 2006; Waltz, 2010). As noted above, the 

market share predictions for MON 87705 Soybean are not available. However, Monsanto has 

estimated that the acreage potential in the U.S. for its Vistive III soybean variety, a high oleic 

and low linolenic product, at 10 to 20 million acres, or potentially up to 25% of the U.S. market 

(see Petition Addendum 1and (AGRA, 2009)). 

The value to the consumer from the changes presented in MON 87705 Soybean is a direct 

function of the physical and chemical changes associated with the changed concentrations of the 

fatty acids. MON 87705 Soybean was developed as a response to challenges associated with the 

composition of conventional soybean oil (Rogan, 2010). The double bonds in the 

polyunsaturated fatty acids, particularly linolenic acid, are susceptible to oxidation resulting in 

the formation of “fishy” or acrid flavors and odors, reducing shelf-life and product stability 

(Dutton, et al., 1951; Rogan, 2010). Chemical hydrogenation had been adopted to reduce the 

content of polyunsaturated fatty acids (linoleic and linolenic acids); however, in the 1990s, 

nutrition research showed that the trans fatty acids created by the hydrogenation process had 

negative health consequences (Judd, et al., 1994; Mensink & Katan, 1990; Zock & Katan, 1992). 

In addition, the saturated fatty acids, particularly palmitic acid, were also identified as 

contributing to cardiovascular disease (Rogan, 2010). 

MON 87705 Soybean provides substantially reduced levels of polyunsaturated fatty acids. 

Linoleic acid is produced at concentrations of approximately 10% of total fatty acid content, as 

compared with approximately 53% in convention soybean (Rogan, 2010). Comparable 

reductions in palmitic acid are also shown, with approximately 2% of total fatty acid as 

compared with nearly 11% in conventional soybean oil (Rogan 2010, see Table VII-1, page 97). 

While the polyunsaturated and saturated fatty acid concentrations are reduced, the concentrations 

of oleic acid, a mono-unsaturated fatty acid, are increased, to over 76% of the volume when 

compared with approximately 23% in conventional soybean oil. The concentration of linolenic 

acid in the MON 87705 Soybean oil is functionally the same as commodity soybean oil, 

approximately 7% of the total. High oleic acid content in the soybean oil provides oxidative 
DRAFT MONSANTO 87705 SOYBEAN 

 74 

stability, which in turns preserves shelf stability and reduces the need for hydrogenation (Rogan, 

2010). 

These characteristics are perceived to be of value in the human food applications, as well as 

certain industrial applications. The food value is based on the reduction in reduced level of 

polyunsaturated fatty acids, the higher oxidative stability without the need for hydrogenation, a 

reduced concentration of trans fatty acids associated with the decrease in hydrogenation, and 

lower levels of saturated fats compared to commodity soybean (AGRA, 2009; Rogan, 2010). 

Increased oxidative stability is also a valuable aspect of certain industrial lubricant uses (Rogan, 

2010; USB, 2010). Low saturated fats and high (>70%) oleic acid levels are key attributes for 

vegetable oils targeted for biodiesel and industrial uses because these characteristics are vital to 

improved cold weather performance, improved stability, and reduced nitrous oxide emissions 

(AGRA, 2009; Graef, et al., 2009; Knothe, 2005; Rogan, 2010). High concentrations of oleic 

acid in the soybean oil provide thermal oxidative and hydrolytic stability (AGRA, 2009). At 

current pricing, high oleic soybean oil has the potential to be a cost-effective replacement for a 

portion of Group 1+ and/or Group 32

 oil, even with a premium for identity preservation (USB, 

2010). 

The costs of developing and managing ID specialty soybean crops have been identified as a 

barrier to the market, so price premiums such as noted above are essential for these specialty 

soybeans to be adopted (Pritchett, et al., 2002). The cost for entry into the ID system has been 

estimated as high as 25% above the cost of conventional crop production (Smyth & Phillips, 

2002). Consumers of specialty crops also have cost burdens associated with these crops. In 

addition to the costs incurred for specialty crop production, specialty crop consumers accrue 

added IDP costs from five general activities: certifying and obtaining ingredients; testing 

ingredients or final products; separating equipment and facilities; scheduling production and 

conducting changeover procedures; and conducting recordkeeping (Muth, et al., 2003). 

These IP management costs may be offset by premium value received for the crop and the 

product, as well as increased yields for certain IP varieties. Pritchett reports that specialty 

soybean yields are generally higher than those reported for commodity soybeans, which he 

attributes to either the managerial talent of the specialty grower or higher land quality which is 

recognized and optimized by the grower (Pritchett, et al., 2002). There is no information 

whether these market entry costs for cultivation and use of specialty soybean would be offset by 

 

2

 There are four different types of base stock used in the motor oil market today. 

Group 1 - Conventional - Mineral oil derived from crude oil 

Group 2 - Hydroprocessed - Highly refined mineral oil 

Group 3 – Severe hydroprocessed - Ultra refined mineral oil 

Group 4 – Full synthetics (chemically derived) - Chemically built Polyalphaolefins (PAO). 

Groups 1 – 3 basestocks are derived from crude oil pumped from the ground ; Group 4 basestocks are chemically 

derived, most often from ethylene gas, and contain none of the contaminants present in mineral oils (see 

http://www.mobil.com/australia-english/lcw/audiences/synthetic_v_mineral.asp) 
DRAFT MONSANTO 87705 SOYBEAN 

 75 

increased yields and premium prices for the products of MON 87705 Soybean. Irrespective of 

the value added application of oils derived from MON 87705 Soybean, adherence to soybean ID 

practices will be essential to ensure that the crop value is preserved. 

In the alternative, inadvertent consumption of MON 87705 Soybean by a user desiring an 

alternative fatty acid composition may give rise to negative impacts to those consumers. For 

example, the taste commonly associated with fried food is due to the presence of linoleic acid 

(AGRA, 2009). High-oleic acid soil oils are not considered ideal for fried food applications 

(AGRA, 2009). If a shipment of MON 87705 Soybean were inadvertently processed for fried 

food applications, the resulting food products would likely be rejected. 

The need to maintain identity and control product characteristics are similar concerns in 

industrial applications. For example, high oleic acid soy oil has value in oleo-chemical 

applications, including lubricants, coatings and paints and foam products, as well as a feedstock 

for biodiesel applications (AGRA, 2009; Graef, et al., 2009; Knothe, 2005). In contrast, oils 

with high concentrations of linolenic acid are comparable to linseed oil and are very desirable in 

the coatings industry where they are used to enhance drying of paints, inks, and varnishes 

(Cahoon, 2003). While the inadvertent substitution of one specialty oil for another specialty oil 

is highly unlikely, the results of such an accidental substitution in the industrial sector are 

nonetheless substantial. If the ID practices preserving the distinction between MON 87705 

Soybean and either conventional soy oil or other specialty oils are not maintained, desired oil 

composition would be compromised and the product would not meet its specifications. 

It is conceivable that MON 87705 Soybean might only be cultivated as a specialty crop because 

of the specialized ID practices required to preserve product integrity. Market share predictions 

for MON 87705 Soybean are not available. However, Monsanto has estimated that the acreage 

potential in the United States for its Vistive III soybean variety, a high oleic and low linolenic 

product, at 10 to 20 million acres, or potentially up to 25% of the U.S. market (AGRA, 2009). 

As with the MON 87705 Soybean derived product, these low-lin varieties have a lower saturated 

fat content than that of partially hydrogenated commodity soybean oil. Cultivated as specialty 

crops, these varieties provide the grower with a premium price as high as $1.25 per bushel 

(Conley & Gaska, 2008). In 2005, when Monsanto introduced the low-linolenic soybean 

“Vistive” variety, food producers such as Kellogg noted that there was a high demand and 

significant shortage for soy oils with these traits (Woznicki, 2005). MON 87705 Soybean 

market share will be contingent on a demonstrated price and high yield potential as well as 

consumer and producer preference to other modified fatty acid soybean varieties. 

Net income differentials cannot be projected. The net income of soybean producers growing 

only herbicide-tolerant soybean is not available (USDA-ERS, 2010d). However, as Monsanto 

anticipates that MON 87705 Soybean would be cultivated as a specialty crop, resulting domestic 

socioeconomic impacts are expected to be similar to the no action alternative and are contingent 

on adherence to ID practices at all stages of MON 87705 Soybean cultivation and production. 
DRAFT MONSANTO 87705 SOYBEAN 

 76 

Cumulative Effects: Domestic Economic Environment 

MON 87705 Soybean is intended to be cultivated as a specialty soybean product and its oil 

fraction will be produced and utilized within an IDP system (Rogan, 2010). Consistent with the 

agronomic analyses conducted by Monsanto, a determination of nonregulated status of MON 

87705 Soybean is not expected to result in an increase in acreage devoted to cultivation of 

soybean, but could potentially replace existing specialty soybean varieties for those growers 

seeking a new specialty oil product which also presents herbicide tolerance. 

Monsanto anticipates that MON 87705 Soybean will be cultivated as a specialty soybean 

(Rogan, 2010). Agronomic and phenotypic analyses conducted by Monsanto did not 

demonstrate any substantial differences between MON 87705 Soybean and convention varieties, 

and none of the modifications expressed by MON 87705 Soybean are considered likely to result 

in new acreage devoted to soybean cultivation outside of those regions where soybean is 

currently cultivated (Rogan, 2010). Consistent with this expectation that MON 87705 Soybean 

will be a specialty product, with new agronomic characteristics providing benefits for cultivation 

beyond traditional soybean cultivation regions, a determination of nonregulated status of MON 

87705 Soybean is not expected to lead to an expansion of U.S. soybean acreage. 

The percentage of the U.S. soybean acreage dedicated to specialty oil soybeans does have the 

potential to change, contingent upon market acceptance and consumer demand, and specific 

applications of the specialty products. 

Monsanto has indicated that MON 87705 Soybean will be bred with current, commercially 

available low-linolenic acid soybean varieties to further enhance the oxidative stability of 

soybean oil (Rogan, 2010). Monsanto’s Vistive low-linolenic variety has been conventionally 

bred with MON 87705 Soybean, and this has produced a variety that is substantially reduced in 

linolenic acid (Table 2, Addendum 1, Rogan (2010)). Related varieties include, for example, 

four ultra-low linolenic acid varieties introduced by the Iowa State University Research 

Foundation (Iowa State University, 2008). The four varieties introduced by Iowa State include 

three non-GE varieties: IA2096, IA2097, and IA3042; and IA2098RR, a GE variety which also 

expresses glyphosate resistance (Iowa State University, 2008). Low linolenic varieties may be 

used for blending with other oils, such as those high in oleic acid (Cargill, 2011). The producers 

of these existing low linolenic acid soybean varieties could experience a decrease in demand 

because the need for blending would decline, and because MON 87705 oils would be used as a 

replacement. Introduction of MON 87705 may result in a conversion of commodity soybean 

acreage to this or other specialty soybean varieties. 

MON 87705 Soybean has the potential to displace other non-soy oil crops. Competitors in the 

food market include corn oil, canola oil, cottonseed oil, peanut oil, olive oil, palm oil and 

sunflower oil. While soybean oil lost market share to other food oils after the 2006 FDA trans

fat labeling requirements, it is nonetheless the least expensive domestic vegetable oil (USDAERS, 2011). Table 4-3 provides a summary of the comparative prices for these commodity oils 

over the past decade. For the past decade, soybean oil has consistently been the least expensive 

domestic vegetable oil (USDA-ERS, 2011). If MON 87705 Soybean oil achieves market 

acceptance, the product has the potential to displace other vegetable food oils, including canola 

and sunflower oils presenting similar high-oleic oil characteristics. 
DRAFT MONSANTO 87705 SOYBEAN 

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Table 4-3: U.S. Vegetable Oil Prices (dollars/gallon) 

Marketing 

Year Soybean Oil 

Cottonseed 

Oil Sunflower oil Canola Oil Peanut Oil Corn Oil 

2000/01 1.09 1.23 1.22 1.35 2.69 1.044 

2001/02 1.27 1.38 1.79 1.81 2.48 1.47 

2002/03 1.70 2.91 2.55 2.29 3.60 2.17 

2003/04 2.31 2.40 2.57 2.60 4.68 2.19 

2004/05 1.77 2.16 3.37 2.37 4.13 2.15 

2005/06 1.80 2.27 3.13 2.39 3.42 1.94 

2006/07 2.39 1.98 4.47 3.12 4.08 2.45 

2007/08 4.01 5.66 7.02 5.05 7.28 5.34 

2008/09 2.48 2.09 3.87 3.04 6.04 2.52 

2009/10 2.77 3.01 4.07 3.30 4.59 3.03 

2010/11 4.27 4.46 5.92 4.77 6.31 4.65 

Source: (USDA-ERS 2011, Table 9, converted to dollars per gallon based on a vegetable oil conversion factor of 

7.7 pounds per gallon). 

4.6.2 Trade Economic Environment at Risk 

Although soybean oil constitutes only a small percent of soybean weight (approximately 19%), 

soybean oil accounts for up to 65% of all vegetable oil and fat consumed in the U.S. (USDAERS, 2010d). The worldwide market share is not as high. Until 2005, soybean oil was the 

largest source of vegetable oil worldwide (USDA-ERS, 2010d). In 2005, however, palm oil 

overtook soybean oil in volume of production; palm oil and rapeseed oil (canola) production are 

expected to continue to grow over the next few years (USDA-ERS, 2010d). In 2009, the U.S. 

exported 1.3 billion bushels (34.9 million metric tons) of soybean, which accounted for 46% of 

the world's soybean exports (SoyStats, 2010b). In total, the U.S. exported $16.5 billion USD 

worth of soybean and soybean products in 2009 (SoyStats, 2010c). China is the largest export 

market for U.S. soybean with purchases totaling $9.2 billion. Mexico is the second largest 

export market with sales of $1.3 billion in the same year (SoyStats, 2010c). Other significant 

markets include Japan and the EU. 

The global demand for soybeans is expected to increase by a full third over 2010 consumption in 

the next ten years, with China accounting for 80% of the expected increase in total demand 

(FAPRI, 2009; Hartnell, 2010). China and India are predicted to import 46% of the total 

soybean market by 2018/2019 (FAPRI, 2009). The USDA has predicted that U.S. exports will 

remain flat during much of this period, as a result of increase in domestic consumption and 

competition from South America (FAPRI, 2009; USDA-ERS, 2009). To a certain extent, 

competition with South American producers will be offset by increased demand from China 

(FAPRI, 2009). The USDA predicts that the U.S. share of this export market could potentially 

decline from the current 46% to 30% at the end of the decade (FAPRI, 2009; USDA-ERS, 2009). 

It is also noted that as a result of higher prices for vegetable oils as a result of increased demand 

for food use as well as for biodiesel and other industrial uses, previously uncropped land in 

Brazil, Indonesia, and Malaysia are being brought into production for soybean and palm oil 

(USDA-ERS, 2009). This will increase global competition for export market share. 

Income benefits from cultivation of herbicide tolerant soybeans have been substantial. Global 

farm income has been estimated to have increased over 6% in 2007 as a consequence of adopting 
DRAFT MONSANTO 87705 SOYBEAN 

 78 

these varieties (Brookes & Barfoot, 2010; Hartnell, 2010). Global gains from adoption of 

herbicide-tolerant soybeans have been estimated as high as $7 billion per year (Hartnell, 2010). 

Continued expansion of these crops internationally will be an extension of consumer demand as 

well as government regulation of GE commodities. 

Costs of production also play a role in U.S. soybean export competitiveness. In Argentina, for 

example, the cost of herbicide-tolerant soybean production is substantially lower than U.S. costs 

because Monsanto was unable to patent the technology in Argentina (Brookes & Barfoot, 2010). 

As a consequence, Argentinian growers are able to save seed and not pay technology fees or 

royalty fees on farm-saved seed (Brookes & Barfoot, 2010). 

No Action: Trade Economic Environment 

Approximately 93% of the soybean varieties currently cultivated in the U.S. are GE varieties 

(USDA-ERS, 2010a, 2010b). Specialty soybeans comprise approximately 12% of the soybean 

acreage (MSA, 2009). U.S. soybeans will continue to play a role in global soybean production, 

and will continue to be a supplier in the international market. 

Under the No Action alternative, there would be no changes to the existing soybean market. 

Preferred Alternative: Trade Economic Environment 

To support commercial introduction of MON 87705 Soybean in the U.S., regulatory submissions 

will be made by the petitioner to countries that import significant quantities of soybean or its 

processed fractions from the U.S. and have established regulatory approval processes in place 

(Rogan, 2010). These will include submissions to a number of foreign government regulatory 

authorities, including: Ministry of Agriculture, People’s Republic of China; Japan’s Ministry of 

Agriculture, Forestry, and Fisheries (MAFF) and the Ministry of Health, Labor, and Welfare 

(MHLW); the Canadian Food Inspection Agency (CFIA) and Health Canada; the Intersectoral 

Commission for Biosafety of Genetically Modified Organisms (CIBIOGEM), Mexico; the 

European Food Safety Authority (EFSA); and the regulatory authorities in other soybean 

importing countries with functioning regulatory systems. As appropriate, notifications of 

importation will be made by the petitioner to importing countries that do not have a formal 

approval process. 

MON 87705 Soybean is intended to be cultivated as a specialty GE soybean variety and the low 

saturated fat, high-oleic acid soybean oil will be produced and processed utilizing an identity 

preservation system to capture the food quality value of the oil (Rogan, 2010). The cultivation of 

MON 87705 Soybean is not expected to result in an increase in the total acreage devoted to 

soybean cultivation, although the allocation of acreage to specialty soybean cultivation could 

increase contingent upon market demand. As with the No Action Alternative, U.S. soybeans will 

continue to play a role in the global soybean market. 

To the extent that the modified fatty acid soybean oil derived from MON 87705 Soybean 

achieves market acceptance, it is conceivable that this soybean-based oil could displace other 

high-oleic vegetable oils in the international market. Products potentially displaced by MON 

87705 Soybean oil include high-oleic canola and sunflower oils, both of which have been 
DRAFT MONSANTO 87705 SOYBEAN 

 79 

marketed as high-stability, high-oleic products (see, e.g., Canola Council 2011a; 2011b; NSA, 

2006). 

Consistent with the potential increase in international demand for this specialty oil product, as 

well as price competitiveness illustrated above in Table 4-3, a determination of nonregulated 

status of MON 87705 Soybean may have a positive benefit on U.S. exports as soy oil based on 

this product displaces other high-oleic food oils. The international market share of MON 87705 

Soybean as a high-oleic variety is contingent on global vegetable oil market requirements, food 

processor acceptance, consumer preference, demonstrated availability of the product, and price 

competitiveness (Rogan, 2010). One economic analysis of a similar high oleic soybean predicts 

that in the environment of high acceptance by consumers, along with high consumption, coupled 

with low price of the oil, the US may obtain a higher share of the world oil market for soybeans 

Giannakas and Yiannaka, 2010). However, with an inability to predict the size of these variable 

inputs, APHIS cannot reliably foresee the outcome for an increase in world market share of 

soybean resulting from planting of this variety. 

Global sensitivities to GE products, including international restrictions on import of GE products 

and inability of the petitioner to gain local approval for cultivation or importation, will continue 

to impede trade with those countries. These challenges to international trade in GE products are 

already in place. Restrictions on international trade in GE products, including MON 87705 

Soybean, are unlikely to change with a determination of nonregulated status of MON 87705 

Soybean. 

A determination of nonregulated status of MON 87705 Soybean will not adversely impact the 

trade economic environment and could potentially enhance it through the subsequent 

development and global adoption of the MON 87705 Soybean line and its products. The MON 

87705 Soybean follows trends in the development of specialty soybeans with modified fatty acid 

profiles. The trade economic impacts associated with a determination of nonregulated status of 

MON 87705 Soybean are anticipated to be very similar to the No Action Alternative. 

Cumulative Effects: Trade Economic Environment 

Consistent with the analysis of international markets for GE soybean, low saturated fat and higholeic vegetable oils, and GE crops generally, APHIS has determined that there are no past, 

present, or reasonable foreseeable effects of the proposed action which would present a negative 

cumulative impact on the trade economic environment. Since 2006, as a result of the FDA trans

fat labeling requirement, the U.S. soybean growers have lost market share to other vegetable oils 

with presenting lower saturated and trans fats, as well as higher oxidative stability, including 

high-oleic canola and sunflower oils (Waltz, 2010). MON 87705 Soybean is one of several 

soybean varieties developed in the attempt to recapture soybean’s market share for food oil 

(Waltz, 2010). Contingent upon producer and consumer acceptance, availability, and price, 

MON 87705 Soybean has the potential to displace some of these comparable, non-soybean 

vegetable oils on the international market. 
DRAFT MONSANTO 87705 SOYBEAN 

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4.6.3 Social Environment at Risk 

The social environment evaluated in this subsection relates to the general soybean farm, as well 

as the individuals or workers employed by the businesses potentially impacted by this product, 

including food processers and industrial users. 

Data from the 2007 Census of Agriculture indicated that 279,110 U.S. farms raised soybeans in 

2007, down from 511,000 in 1982 (USDA-ERS, 2010d; USDA-NASS, 2007). Although acreage 

planted to soybeans was also lower in 2007 than in 2002 as growers shifted to corn production, 

harvested soybean acreage per farm increased from 114 acres in 1978 to 229 acres in 2007 

(USDA-ERS, 2010d). Although small farms with less than 250 acres accounted for 72% of the 

farms growing soybeans, these farms produced only 26% of the 2007 crop (USDA-ERS, 2010d). 

Irrigation was used on 5.2 million acres of soybean, or 8% of U.S. soybean acreage in 2007 

(USDA-ERS, 2010d). Individual or family farms accounted for 81% of all soybean farms in 

2007 and 69% of soybean production, with the balance identified largely as partnerships and 

small family-held corporations; corporations accounted for less than 1% of soybean farms and 

soybean production (USDA-ERS, 2010d). 

Farms which specialized in soybean production have been reported as generally smaller in terms 

of farm size and sales than farms which do not specialize in soybean cultivation (USDA-ERS, 

2006b). Many of the farms which specialize in soybean cultivation have reported non-farm 

incomes. Fewer than half of the growers specializing in soybean cultivation listed farming as 

their primary occupation (36%); whereas, 65% of growers who cultivated a wide variety of crops 

on less specialized soybean farms reported farming as the primary occupation (USDA-ERS, 

2006b). 

Average acreage of all operated soybean farms is reported as approximately 623 acres; whereas, 

the average acreage of a more specialized soybean farm operator is reported at 390 acres 

(USDA-ERS, 2006b). Nearly 60% of these specialty soybean farmers reported annual income 

less than $40,000; whereas, 76% of commodity soybean farmers reported incomes exceeding 

$40,000 per year (USDA-ERS, 2006b). 

No Action: Social Environment 

Under the No Action Alternative, there would be no changes from the status quo impacts on the 

social environment surrounding soybean farming, food processing, or industrial uses. The 

cropping and marketing decisions currently made by soybean growers are unlikely to change 

with the selection of this alternative. 

Preferred Alternative: Social Environment 

MON 87705 Soybean is not intended to confer any competitive advantage in terms of weediness 

or to extend the range of cultivation outside of existing cultivation areas. Monsanto expects that 

MON 87705 Soybean will be cultivated as a specialty crop, with the low saturated fat, high oleic 

acid soybean oil produced and processed under existing identity protection systems to capture 

the food quality value of the oil (Rogan, 2010). The variety will be bred with conventionally 

obtained low linolenic acid soybeans, and so will also express this trait (Rogan, 2010, 
DRAFT MONSANTO 87705 SOYBEAN 

 81 

Addendum I). Consistent with the expectations that this variety is to be cultivated as a specialty 

crop, a determination of nonregulated status of MON 87705 Soybean is not expected to result in 

an expansion of the number of soybean acres. Soybean acreage is expected to remain stable, and 

overall impacts relative to the total soybean market system are similar to the No Action 

Alternative. 

To the extent that MON 87705 Soybean is accepted by producers and consumers, MON 87705 

Soybean has the potential to displace other specialty soybean varieties. Those growers currently 

cultivating specialty soybean varieties have already invested in equipment and practices to 

maintain the identity of the product from seed through harvest and processing and would not be 

impacted by this change. To the extent that a grower currently cultivating commodity soybean 

elects to cultivate MON 87705 Soybean, that grower will need to invest in handling equipment 

and management practices to capture and preserve the food quality value of the oil. Growers 

adopting specialty varieties already make such investment decisions based upon perceived value 

and return on investment (Iowa State University, 2008). 

The soybean market also includes seed production, equipment manufacturers, handlers, and 

producers. Monsanto’s analysis of agronomic characteristics did not identify any differences 

between MON 87705 Soybean and conventional varieties (Rogan, 2010). Monsanto expects that 

MON 87705 Soybean would be cultivated, handled, and processed consistent with existing 

identity protection practices and systems (Rogan, 2010). Other than equipment required to 

maintain identity protection, no specialized equipment is required to cultivate, handle, or process 

MON 87705 Soybean. Although there is some expectation that specialty soybean production 

will gradually increase to meet the demands now met by hydrogenated soybean oils and other 

vegetable oils which have the high oleic, low linolenic traits (Rogan, 2010), these increases 

would most likely be accompanied by decreases in production of conventional commodity 

soybean. Thus, there may be movement of some growers into increased specialty soybean 

production and required investment into mechanisms needed to adequately segregate the adopted 

variety of soybean (because it would be an identity preserved product). However, any choices 

made by growers will be voluntary ones, based upon consideration of the costs of conversion, 

prices of the identity preserved soybean, and necessary commitments to changes required by any 

such conversion. In the event that all these considerations were favorable ones for the growers, 

some economists propose that there is potential for economic gains beyond those accruing from 

production of conventional commodity soybean (Giannakas and Yiannaka, 2010). 

Food processors potentially impacted by MON 87705 Soybean include those parts of the 

industry using soybean oil for frying, and cooking oil, and shortening products where shelf life 

and oxidative stability are important features. Monsanto intends to market the low saturated fat, 

high-oleic fatty acid content of MON 87705 Soybean oil as a replacement product for 

comparable existing oils, including canola and sunflower oils (Canola Council, 2011a; NSA, 

2006; Rogan, 2010) and other uses where hydrogenated soybean oils are currently employed 

(Addendum 1, Rogan, 2010). Because these other modified oil products are already present in 

the commodity oil market and routinely handled by processors using standard industry 

processing methods and equipment, no new processes or equipment are required to introduce 

MON 87705 Soybean. Thus, workers in these areas are not likely to be impacted by any major 

alterations of soybeans or of qualities of soybeans processed. 
DRAFT MONSANTO 87705 SOYBEAN 

 82 

Monsanto has evaluated the market and trade applications of MON 87705 Soybean, and has 

determined that this product is appropriate for all the same uses as hydrogenated soybean 

(Rogan, 2010). In the event that MON 87705 Soybean is introduced into a commodity oil, the 

result would be a reduction in saturated and polyunsaturated fats, which would improve the 

functionality of the oil and improve the nutritional profile (Rogan, 2010). Other consequences 

for applications using soybean oils have been examined by Monsanto, and are noted in the EA 

section, 4.6.1, Domestic Economic Environment. 

Potential impacts to industrial users of soybean products are similar. Existing identity protection 

measures are already in place to allow industrial users to manage feedstocks and products for 

specific applications and needs (Smyth & Phillips, 2002; Sonka, et al., 2004). No new 

equipment or practices are required to incorporate MON 87705 Soybean into this industrial 

market. However, for industrial users that require close tolerances in the ratios of fatty acid to 

ensure product quality, continuous monitoring of properties of input oils may be necessary. This 

scrutiny may already have been enhanced, given that the industry has increasingly begun to 

encounter and already needs to manage an increasing range of different soy-based feedstocks, 

ranging from ultra-low linolenic acid varieties, through and including feedstock oils for blending 

from other crops, such as high-oleic and high linolenic varieties that have various uses (APAG, 

2011; USB, 2010). Thus, APHIS does not expect that changes to the social environment 

including workforce will be altered by entry of this variety into the soybean market. 

Consistent with the above assessment of potential impacts to the growers, and workforce in the 

food processing and industrial use categories, the impacts of a determination of nonregulated 

status of MON 87705 Soybean are expected to be the same as the No Action Alternative. 

Cumulative Effects: Social Environment 

Based on the information described above, APHIS has determined that there are no past, present, 

or reasonably foreseeable actions that in aggregate with effects of the proposed action would 

impact the social environment surrounding soybean farming. 

4.7 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:
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 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 B). 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: 

 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. 

In following this process, APHIS evaluated the potential effects that a determination of 

nonregulated status to MON 87705 Soybean would have on Federally listed threatened and 

endangered species and species proposed for listing, as well as designated critical habitat 

and habitat proposed for designation. Based upon the scope of the EA and production areas 
DRAFT MONSANTO 87705 SOYBEAN 

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identified in the Affected Environment section of the EA, APHIS obtained a list of TES 

species (listed and proposed) for each state where soybean is commercially produced from 

the USFWS Environmental Conservation Online System (ECOS), see Appendix C. 

As discussed above in the analysis of Gene Movement and Weediness and Plants, APHIS 

has determined that there is no risk to unrelated plant species from the cultivation of MON 

87705 Soybean. Monsanto submitted results of a comparison of agronomic and phenotypic 

differences between MON 87705 Soybean and conventional soybean; no differences were 

identified (Rogan, 2010; USDA-APHIS, 2010a). Consistent with these studies, APHIS has 

concluded the determination of nonregulated status of MON 87705 Soybean does not 

present a plant pest risk, does not present a risk of weediness, and does not present an 

increased risk of gene flow when compared to other currently cultivated varieties. 

Accordingly, APHIS focuses our assessment of potential impacts on TES animal species, 

particularly those potentially at risk from the consumption of MON 87705 Soybean. Few 

TES animal species are likely to frequent soybean fields because the habitat would not be 

suitable. Some animal species, particularly migratory birds, may visit soybean fields, but 

their presence would be fleeting as the habitat is either not suitable or does not contain 

constituent elements required by the species. An exception may be the Delmarva fox 

squirrel (Sciurus niger cinereus). Once found throughout the Delmarva Peninsula, remnant 

populations of the Delmarva fox squirrel now persist naturally only in portions of Queen 

Anne's, Talbot, and Dorchester Counties in Maryland. Translocated populations now exist 

in other areas of Maryland, Virginia, Delaware and a small area in Chester County, 

Pennsylvania. The fox squirrel is found mostly in mixed stands of mature (acornproducing) hardwoods and mature loblolly pines. Other areas include groves of trees along 

streams and bays, small woodlots in agricultural fields and forest near salt marshes. (see 

http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A00B). Diet 

includes acorns, nuts/seeds of hickory, beech, walnut, and loblolly pine; buds and flowers of 

trees, fungi, insects, fruit, and an occasional bird egg. They will feed largely on green pine 

cones when these are available, and often forages on the ground (NatureServe, 2010). It is 

not certain that squirrels actually feed on soybean, although other wildlife certainly do 

{Havera, 1980 #622}. Some reports indicate that soybean is consumed by tree squirrels 

{Craven, 1995 #623}) 

It is reasonable to assume that populations of the species adjacent to soybean production 

fields could be impacted by aspects of cultivation of MON 87705 Soybean or could feed on 

MON 87705 Soybean. The EPA and the FDA have conducted independent evaluations of 

these potential risks directly relevant to APHIS’ analysis. 

Monsanto evaluated compositional aspects of MON 87705 Soybean and compared these 

data with conventional soybean composition. Differences were observed in the 

concentrations of three other fatty acids (18:3 linolenic acid, 20:0 arachidic acid and 20:1 

eicosenoic acid), total fat, and two amino acids (arginine and cysteine) (US-EPA, 1993b). 

APHIS evaluated the differences reported in these compositional elements, and has 

determined that the reported differences are within the 99% tolerance interval for soybean 

composition (see Rogan, 2010, Table E-13, page 303). Accordingly, although statistically 

significant differences in concentrations in these constituents were identified between MON 
DRAFT MONSANTO 87705 SOYBEAN 

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87705 Soybean and conventional soybean, the reported values for MON 87705 Soybean are 

within the acceptable tolerance ranges. As discussed above in Subsection 4.4.2, the analysis 

of potential impacts to animals consuming MON 87705 Soybean, the FDA has completed 

its consultation on this product and concluded that the consumption of MON 87705 Soybean 

presents minimal risk to animals consuming this crop (US-FDA, 2011). Because the 

composition of MON 87705 Soybean is similar to other commercial soybean plants with the 

exception of having tolerance to glyphosate and enhanced levels of the certain fatty acids 

with no expected hazards associated with consumption, it is unlikely that MON 87705 

Soybean poses a hazard to TES animal species. Because no hazards are identified, the risk 

of MON 87705 Soybean affecting TES animal species is also unlikely, regardless of 

exposure. 

Additionally, the EPA has published an exemption from tolerance for the cp4 epsps gene 

and the material necessary for its production in all plants (US-EPA, 1996). Roundup 

Ready® crops incorporating the cp4 epsps gene have been marketed since the mid-1990s 

with no reports of any non-target impacts associated with exposure to or consumption of the 

modified crop. Accordingly, no impacts to TES are anticipated as a result of exposure to 

the cp4 epsps gene in MON 87705 Soybean. 

With regard to the utilization of glyphosate as the herbicide of choice for MON 87705 

Soybean, the EPA has conducted a review of the potential impacts to non-target species, and 

has determined that when used in accordance with the FIFRA label, the potential impacts to 

non-target species is not significant (US-EPA, 1993a, 1993b). As the action agency for 

pesticide registrations, EPA has the responsibility to conduct an assessment of effects of a 

registration action on TES. The EPA Endangered Species Protection Program web site, 

http://www.epa.gov/espp/, describes the EPA assessment process for endangered species. 

Some of the elements of that process, generally taken from the web site, are summarized 

below. 

When registering a pesticide or reassessing the potential ecological risks from use of a 

currently registered pesticide, EPA evaluates extensive exposure and ecological effects data 

to determine how a pesticide will move through and break down in the environment. Risks 

to birds, fish, invertebrates, mammals and plants are routinely assessed and used in EPA’s 

determinations of whether a pesticide may be licensed for use in the U.S. 

EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in 

place for all populations of nontarget species, including TES. These assessments provide 

EPA with information needed to develop label use restrictions for the pesticide. These label 

restrictions carry the weight of law and are enforced by EPA and the states (Federal 

Insecticide, Fungicide, and Rodenticide Act 7 USC §136j (a)(2)(G) Unlawful acts). 

Because TES may need specific protection, EPA has developed risk assessment procedures, 

described in the Overview of the Ecological Risk Assessment Process (US-EPA, 2004), to 

determine whether individuals of a listed species have the potential to be harmed by a 

pesticide; and if so, what specific protections may be appropriate. EPA’s conclusion 

regarding the potential risks a pesticide may pose to a listed species and any designated 

critical habitat for the species, after conducting a thorough ecological risk assessment, 

results in an "effects determination" in accordance with Section 7 (a)(2) of the ESA. 
DRAFT MONSANTO 87705 SOYBEAN 

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As a part of EPA’s TES effects assessment for the California red-legged frog (US-EPA, 

2008), EPA evaluated the effect of glyphosate use at rates up to 7.95 lb a.i./A on fish, 

amphibians, aquatic invertebrates, aquatic plants, birds, mammals, and terrestrial 

invertebrates. The EPA assessment was uncertain of the effects on terrestrial invertebrates, 

citing the potential to affect small insects at all application rates and large insects at the 

higher application rates. 

EPA considered these potential effects as part of their review process and label use 

restrictions for glyphosate tolerant crops imposed under authority of FIFRA. To mitigate 

potential adverse effects to TES, EPA has imposed specific label use restrictions for 

glyphosate use when applied with aerial equipment including “The product should only be 

applied when the potential for drift to adjacent sensitive areas (e.g., residential areas, bodies 

of water, known habitat for threatened or endangered species, non-target crops) is minimal 

(e.g., when wind is blowing away from the sensitive areas).” 

To facilitate pesticide applicators adherence to EPA label use restrictions for glyphosate, 

Monsanto has designed a web-based program (www.Pre-Serve.org), designed to ensure no 

effect of glyphosate applications on threatened and endangered plant species. Pre-Serve 

instructs growers to observe specific precautions including buffer zones when spraying 

glyphosate herbicides on glyphosate-tolerant crops near threatened and endangered plant 

species that may be at risk. In addition, label requirements for Monsanto’s Roundup®

formulations and glyphosate formulations marketed by other manufacturers prohibit 

application in conditions or locations where adverse impact on federally designated 

endangered/threatened plants or aquatic species is likely. 

In conclusion, there are legal precautions in place (EPA label use restrictions) and “best 

practice” guidance to reduce the possibility of exposure and adverse impacts to TES from 

glyphosate application to MON 87705 Soybean. EPA has considered potential impacts to 

TES as part of their registration and labeling process for glyphosate; and adherence to EPA 

label use restrictions by the pesticide applicator will ensure that the use of glyphosate will 

not adversely affect TES or critical habitat. Based on these factors and the legal 

requirements for pesticide applicators to follow EPA label use restrictions, APHIS has 

determined that the use of EPA registered glyphosate for MON 87705 Soybean production 

will not adversely impact listed species or species proposed for listing and would not 

adversely impact designated critical habitat or habitat proposed for designation. 

Based on the above information, APHIS has determined that the Preferred Alternative, a 

determination of nonregulated status of MON 87705 Soybean, would have no effect on 

Federally listed threatened or endangered species and species proposed for listing, or on 

designated critical habitat or habitat proposed for designation. Consequently, a written 

concurrence or formal consultation with the USFWS is not required for this action. 

4.8 OTHER CUMULATIVE EFFECTS 

Potential cumulative effects regarding specific issues have been analyzed and addressed 

above. No further potential cumulative effects have been identified. To date, none of the GE 

soybean varieties that have been deregulated pursuant to Part 340 and the Plant Protection Act 
DRAFT MONSANTO 87705 SOYBEAN 

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and used for commercial soybean production or soybean breeding programs have been 

subsequently found to pose a plant pest risk. 

Specialty soybeans are cultivated to meet specific consumer needs. MON 87705 Soybean is 

anticipated to be cultivated as another specialty soybean, offering growers and consumers an 

option for a high oleic variety also providing herbicide tolerance. Herbicide tolerant soybean is 

already extensively deployed in the seed market, and high oleic traits in other vegetable oil 

sources are also available. No additional potential cumulative impacts to the commodity soybean 

market or the specialty soybean market can be reliably anticipated as a result of deregulation and 

cultivation of MON 87705 Soybean. 

MON 87705 Soybean will compete in the market with other high-oleic, low saturated fat 

vegetable oils, including high oleic canola and sunflower oils (Canola Council, 2011a; NSA, 

2006). MON 87705 Soybean success in replacing these other high-oleic vegetable oils will be 

contingent upon producer and customer acceptance, availability of the product, and price. As 

illustrated in Table 4-3, soybean has been generally less expensive to produce than either of these 

oils. Such a change in market is not unusual, and in this case not dissimilar to the loss in market 

share which soybean has itself experienced following the FDA’s 2006 requirement that foods be 

labeled as to their trans fat content. Since 2006, soybean lost market share to palm and certain 

canola oils (Waltz, 2010). MON 87705 Soybean is one of several soybean varieties developed in 

the attempt to recapture soybean’s market share for food oil (Waltz, 2010). 

Cultivation of stacked varieties, those crop varieties that may contain more than one trait, 

are currently found in the marketplace and in agricultural production. In the event APHIS 

reaches a determination of nonregulated status, MON 87705 Soybean may be combined with 

non-GE and GE soybean varieties by traditional breeding techniques. APHIS’ regulations at 7 

CFR Part 340 do not provide for Agency oversight of GE soybean varieties previously 

deregulated pursuant to Part 340 and the Plant Protection Act, nor over stacked varieties 

combining deregulated GE varieties unless it can be positively shown that such stacked 

varieties were to pose a likely plant pest risk. 

There is no guarantee that MON 87705 Soybean will be stacked with any particular 

deregulated GE variety, as company plans and market demands play a significant role in 

those business decisions. Predicting all potential combinations of stacked varieties that 

could be created using both deregulated GE soybean varieties and also non-GE varieties is 

hypothetical and purely speculative. No further analysis is required. 

4.9 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS 

4.9.1 Executive Orders with Domestic Implications

The following two executive orders require consideration of the potential impacts to minority 

and low income populations and children: 

 Executive Order (EO) 12898 (US-NARA, 2010), "Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income Populations,"
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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 EO 13045. Neither alternative is 

expected to have a disproportionate adverse effect on minorities, low-income populations, or 

children. 

Available mammalian toxicity, along with the history of safe use of CP4 ESPS protein 

conferring tolerance to glyphosate other soybean varieties expressing CP4 ESPS proteins, 

establishes the safety of MON 87705 Soybean and its products to humans, including minorities, 

low income populations, and 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 87705 Soybean are expected to have a disproportionate adverse 

effect on minorities, low income populations, or children. As noted above, the cultivation of 

soybean varieties previously deregulated pursuant to Part 340 and the Plant Protection Act with 

similar herbicide tolerance traits has been associated with a decrease and or shift in pesticide 

applications for those who adopt these varieties that is either favorable or neutral with respect to 

environmental and human toxicity. If pesticide applications are reduced, there may be a 

beneficial effect on children and low income populations that might be exposed to the chemicals. 

These populations might include migrant farm workers and their families, and other rural 

dwelling individuals who are exposed to pesticides through groundwater contamination or other 

means of exposure. It is expected that EPA and USDA Economic Research Service would 

monitor the use of this product to determine impacts on agricultural practices such as chemical 

use as they have done previously for herbicide-tolerant products. 

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. 

Non-engineered soybean as well as other herbicide-tolerant and modified fatty acid soybean 

varieties are widely grown in the U.S. Based on historical experience with these varieties and 

the data submitted by the applicant and reviewed by APHIS, MON 87705 Soybean plants are 
DRAFT MONSANTO 87705 SOYBEAN 

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sufficiently similar in fitness characteristics to other soybean varieties currently grown and are 

not expected to become weedy or invasive (USDA-APHIS, 2010a). 

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. 

Data submitted by the applicant has shown no difference in compositional and nutritional 

quality of MON 87705 Soybean compared to other GE soybean or non-GE-soybean, apart 

from the modification of the fatty acid composition. 

EPA has established an exemption from the requirement of a tolerance for residues of CP4 

EPSPS protein and the genetic material necessary for its production in all plants (US-EPA, 

1996). This exemption was based on a safety assessment that included rapid digestion in 

simulated mammalian gastrointestinal fluids, lack of homology to toxins and allergens, and 

lack of toxicity in an acute oral mouse gavage study. Because the MON 87705 Soybeanproduced CP4 EPSPS protein is equivalent to the exempted CP4 EPSPS protein, a similar 

conclusion can be reached that the MON 87705 Soybean-produced CP4 EPSPS is safe for 

human and animal consumption. 

Monsanto has presented results of field trials conducted to evaluate field phenotypic, 

agronomic and environmental interactions. These data, presented in Appendix G of the 

petition (Rogan, 2010) showed no differences in arthropod damage or arthropod pest and 

beneficial insect abundance between MON 87705 Soybean and other varieties, supporting 

the conclusion that the modified oil trait is unlikely to impact food sources for migratory 

bird species. Migratory bird use of soybean in harvested fields is reduced in terms of 

species numbers as well as population densities compared to their use of corn and sunflower 

fields {Galle, 2009 #625}, so usefulness of soybean for these birds may be for only a 

secondary source of grain. 

The migratory birds that occasionally forage in soybean fields are unlikely to ingest high 

amounts of MON 87705 Soybean seed as soybean seed is limited by seed germination and 

harvest. Exposure to the herbicide glyphosate itself poses minimal risk to birds, fish, and 

invertebrates (US-EPA, 1993a, 1993b). The incorporation of herbicide tolerance in soybean 

products such as MON 87705 Soybean has resulted in the reduction in use of more toxic 

herbicides (USDA-APHIS, 2010c). 

Based on APHIS’ assessment of MON 87705 Soybean, it is unlikely that a determination of 

nonregulated status of MON 87705 Soybean will have a negative effect on migratory bird 

populations. 
DRAFT MONSANTO 87705 SOYBEAN 

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4.9.2 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 careful consideration and does not expect a significant environmental impact outside the 

U.S. in the event of a determination of nonregulated statusof MON 87705 Soybean. It should 

be noted that all the 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 87705 Soybean subsequent to a determination of nonregulated 

status for 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 pest risk analysis (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 includes 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 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. 
DRAFT MONSANTO 87705 SOYBEAN 

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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 (see the NBII 

listings posted at http://usbiotechreg.nbii.gov). 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. 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, 

2003). 

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. 

4.9.3 Compliance with Clean Water Act and Clean Air Act 

This Environmental Assessment evaluated the changes in soybean production due to a 

determination of nonregulated status of MON 87705 Soybean. Cultivation of MON 87705 

Soybean will not lead to the increased production of soybean in U.S. agriculture. 

There is no expected change in water use due to the cultivation of MON 87705 Soybean 

compared to current soybean seed and production regimes. There is no expected change in 

air quality associated with agronomic practices associated with the cultivation of MON 

87705 Soybean. 

Based on this review, APHIS concludes that the cultivation of MON 87705 Soybean would 

inherently comply with the Clean Water Act and the Clean Air Act. 

4.9.4 Impacts on Unique Characteristics of Geographic Areas 

A determination of non-regulated status of MON 87705 Soybean 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. 

The common agricultural practices that would be carried out in the cultivation of MON 87705 

Soybean are not expected to deviate from current practices. The product will be deployed on 

agricultural land currently suitable for production of soybean, will replace existing varieties, and 

is not expected to increase the acreage of soybean production. 
DRAFT MONSANTO 87705 SOYBEAN 

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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 87705 Soybean. 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 87705 Soybean including the use of EPA registered 

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

potential impacts to the human environment. 

4.9.5 National Historic Preservation Act (NHPA) of 1966 as Amended 

The NHPA of 1966, and its implementing regulations (36 CFR 800), requires Federal agencies 

to: 1) determine whether activities they propose constitute "undertakings" that has 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 87705 Soybean will 

not adversely impact cultural resources on tribal properties. Any farming activities that may be 

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

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

APHIS’ proposed action 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 they 

likely cause any loss or destruction of significant scientific, cultural, or historical resources. This 

action is limited to a determination of non-regulated status of MON 87705 Soybean. Standard 

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

used on these agricultural lands including the use of EPA registered pesticides. Applicant’s 

adherence to EPA label use restrictions for all pesticides will mitigate impacts to the human 

environment. 

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 audible elements to areas in which they are used that could result in effects on 

the character or use of historic properties. For example, there is potential for audible effects on 

the use and enjoyment of a historic property when common agricultural practices, such as the 

operation of tractors and other mechanical equipment, are conducted close to such sites. A builtin mitigating factor for this issue is that virtually all of the methods involved would only have 

temporary effects on the audible nature of a site and can be ended at any time to restore the 

audible qualities of such sites to their original condition with no further adverse effects. 

Additionally, these cultivation practices are already being conducted throughout the soybean 

production regions. The cultivation of MON 87705 Soybean does not inherently change any of 

these agronomic practices so as to give rise to an impact under the NHPA. 

 
DRAFT MONSANTO 87705 SOYBEAN 

 93 

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DRAFT MONSANTO 87705 SOYBEAN 

APPENDIX A 

FDA CONSULTATION ON BIOENGINEERED FOODS 

MON 87705 SOYBEAN 

US Food and Drug Administration 

Biotechnology Consultation Note to the File BNF No. 000121 

DATE: January 14, 2011 

Subject: High Oleic Soybean MON 87705 

Keywords: Soybean, Glycine max, glyphosate, cp4 epsps, fatty acid, palmitic acid, oleic acid, 

linoleic acid, FAD2, FATB, RNA interference, MON 87705, Monsanto, herbicide resistant, 

modified oil, high oleic, OECD Unique Identifier MON-877Ø5-6 

Purpose 

This document summarizes FDA’s evaluation of biotechnology notification file (BNF) No. 

000121. In a submission dated October 29, 2009, Monsanto Company (Monsanto) submitted to 

the Food and Drug Administration (FDA) a safety and nutritional assessment of the 

bioengineered soybean MON 87705, which has a fatty acid profile that has been altered from 

that of conventional soybean varieties. Monsanto provided additional information on December 

16, 2009, January 21, 2010, February 15, 2010, March 26, 2010, and June 14, 2010. FDA 

evaluated the information in Monsanto’s submissions to ensure that regulatory and safety issues 

regarding human food and animal feed derived from the new plant variety have been resolved. 

FDA considered all information provided by Monsanto as well as other information available to 

the agency. This document is not intended to restate the information provided in the final 

consultation in its entirety. 

Intended Effect 

The intended effect of the modification in soybean MON 87705 is to produce soybean seeds with 

decreased levels of palmitic and stearic acids and increased levels of oleic acid, with an 

associated decrease in linoleic acid. To accomplish this objective, Monsanto used RNA-based 

suppression of two key endogenous soybean genes [fatty acid acyl carrier protein thioesterase 

(FATB1-A) and fatty acid desaturase (FAD2-1A)], the gene products of which are involved in the 

soybean fatty acid biosynthetic pathway. Monsanto states that FATB1-A and FAD2-1A gene 

segments were assembled in a single suppression cassette under the control of a seed promoter. 

Monsanto states that transcription of the introduced FATB1-A and FAD2-1A gene segments 

produces ribonucleic acids (RNAs) with inverted repeats that form double stranded RNA 

(dsRNA). The dsRNA thus formed suppresses the production of endogenous soybean FATB and 

FAD2 transcripts via RNA interference. The notifier states that this suppression results in the 

altered fatty acid profile in soybean MON 87705. 
DRAFT MONSANTO 87705 SOYBEAN 

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Regulatory Considerations 

The purpose of this evaluation is to assess whether the developer has introduced a substance 

requiring premarket approval as a food additive or has unintentionally adulterated the food with 

respect to the Federal Food, Drug, and Cosmetic Act (FFDCA). 

Genetic Modification and Characterization 

Parental Variety 

The non-transgenic conventional soybean variety A3525 was used as the recipient in the 

transformation to create soybean MON 87705. 

Transformation Vector and Method 

Monsanto used Agrobacterium-mediated transformation of soybean meristem tissue to introduce 

DNA into soybean A3525. The genetic elements introduced into soybean A3525 from 

transformation vector PV-GMPQ/HT4404 include a single copy of T-DNA I cassette and a 

single copy of T-DNA II cassette each flanked by insertion border region sequences. T-DNA I 

contains a partial-suppression cassette, under the control of the 7Sα ́ seed promoter, that contains 

the sense segments of the FAD2-1A intron and the FATB1-A 5 ́ untranslated region (UTR) and 

plastid targeting sequence, and a cp4 epsps expression cassette, under the control of the 

FMV/Tsf1 promoter sequence, that contains the cp4 epsps gene and the CTP2 targeting sequence. 

T-DNA II contains the 3 ́ UTR sequence of the H6 gene and a partial-suppression cassette 

comprised of antisense segments of the FAD2-1A intron and the FATB1-A 5 ́ UTR and plastid 

targeting sequence. 

Characterization, Inheritance, and Stability of the Introduced DNA 

In order to characterize the introduced DNA, Monsanto conducted Southern hybridization 

analyses, DNA sequencing, genomic comparisons, and bioinformatic analyses. Monsanto states 

that the results of the Southern hybridization analyses show that soybean MON 87705 contains a 

single copy of T-DNA I and a single copy of T-DNA II inserted at a single locus in the genome. 

Monsanto notes that further analysis of soybean MON 87705 for plasmid backbone sequence 

using Southern hybridization showed that soybean MON 87705 does not contain any detectable 

backbone sequence from the transformation vector PV-GMPQ/HT4404. 

Monsanto states that the results of DNA sequencing analyses complement the Southern 

hybridization analyses and show that the cassettes within T-DNA I, as well as the cassettes 

within T-DNA II, are intact. 

Monsanto performed open reading frame (ORF) bioinformatic analyses of the junction site 

between the soybean genomic DNA and the inserted DNA to determine whether insertion of the 

introduced DNA might have created any ORF that might encode a toxin or allergen. From the 

bioinformatic analyses, Monsanto concludes that, even in the highly unlikely occurrence of 

translation of any of these ORFs, the polypeptide products are unlikely to exhibit allergenic, 

toxic, or otherwise biologically adverse properties. 
DRAFT MONSANTO 87705 SOYBEAN 

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Monsanto reports that the same hybridization pattern was observed using Southern hybridization 

analyses of genomic DNA isolated from plants from three successive generations. Thus, 

Monsanto concludes that the inserted DNA in soybean MON 87705 is stably integrated into the 

genome. 

During the development of soybean MON 87705, Monsanto recorded segregation data to assess 

the heritability and stability of the inserted coding sequences present in the genome. Based on the 

chi square analysis of the segregation data from three generations, Monsanto concludes that the 

inserted coding sequences of soybean MON 87705 show a Mendelian inheritance pattern as a 

single locus. Monsanto also concludes that the data on trait inheritance, as revealed by chi-square 

analysis, are consistent with the molecular characterization data on the stability of the insert 

across generations. 

Protein Characterization - CP4 EPSPSIdentity, Function, and Characterization 

Monsanto states that the cp4 epsps gene was used as a selectable marker during the 

transformation of the parental soybean variety. Monsanto also states that the CP4 EPSPS protein 

expressed in soybean MON 87705 is identical to the CP4 EPSPS protein in other Roundup 

ReadyTM crops and it confers tolerance to glyphosate. The CP4 EPSPS protein expressed in 

soybean MON 87705 is derived from Agrobacterium sp. strain CP4 and is similar and 

functionally identical to endogenous plant EPSPS enzymes, but has a much lower affinity for 

glyphosate. Monsanto characterized soybean MON 87705-produced CP4 EPSPS protein using 

various analytical techniques1

 and demonstrated the protein’s equivalence with Escherichia coliproduced CP4 EPSPS protein. Due to the low levels of CP4 EPSPS protein produced in soybean 

MON 87705, the E. coli-derived CP4 EPSPS protein was used for safety assessment studies. 

The CP4 EPSPS protein levels in soybean MON 87705 were measured in replicated samples of 

leaf, root, forage, and mature seeds from five field sites using a validated enzyme-linked 

immunosorbent assay (ELISA). Monsanto reports that the range of CP4 EPSPS protein in 

soybean MON 87705 leaf, root, forage, and mature seeds was 40 to 1000 micrograms per gram 

dry weight (μg/g DW). The mean CP4 EPSPS protein concentrations (μg/g DW) in soybean 

MON 87705 were 200 to 530 for leaf at four vegetative stages, 120 for root, 110 for forage, and 

77 for mature seeds. 

Assessment of Potential for Allergenicity and Toxicity 

Monsanto performed studies to assess the potential for allergenicity and toxicity of the CP4 

EPSPS protein. 

Monsanto performed a sequence similarity search of the CP4 EPSPS amino acid sequence 

against the TOX_2009 database (which contains sequences of proteins that may be harmful to 

human and animal health) using the FASTA algorithm. Monsanto states that the results of the 

sequence comparisons show that no relevant alignments (alignments that display an E-score of 

less than 1 x 10-5) were observed between the CP4 EPSPS sequence and sequences in the 

TOX_2009 database.2

 Monsanto thus reports that no structurally relevant similarity exists 

between the CP4 EPSPS protein and any known toxins or other biologically active proteins that 

would be harmful to human or animal health. 
DRAFT MONSANTO 87705 SOYBEAN 

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Monsanto conducted an acute oral toxicity study in mice. A single dose of up to 572 milligrams 

CP4 EPSPS protein per kilogram body weight (mg/kg) was administered by gavage to ten male 

and ten female mice. No treatment-related effects on survival, clinical observations, body weight 

gain, food consumption, or gross pathology were observed. Monsanto thus concludes that the No 

Observable Adverse Effect Level (NOAEL) for CP4 EPSPS is 572 mg/kg. 

Monsanto evaluated the likelihood that health risks would arise from the acute dietary intake of 

CP4 EPSPS protein from consumption of food derived from soybean MON 87705. Monsanto 

calculated the margins of exposure (MOEs) for the general population and for non-nursing 

infants to be 43,600 and 1,100, respectively. Monsanto concludes that these large MOEs indicate 

that there are no meaningful risks to human health from dietary exposure to the CP4 EPSPS 

protein derived from soybean MON 87705. 

Monsanto notes that soybean is one of the eight major food allergens. Monsanto compared the 

amino acid sequence of the CP4 EPSPS protein to the amino acid sequences of known allergens 

in the Food Allergy Research and Resource Program Database (FARRP_2009) using the FASTA 

sequence alignment program. None of the identified alignments meet the threshold of greater 

than or equal to 35% identity over 80 amino acids, and no contiguous stretches of 8 or greater 

amino acids are shared between the CP4 EPSPS protein and the proteins in the allergen 

database.3

Monsanto also reports that the CP4 EPSPS protein is rapidly (< 15 seconds) degraded in 

simulated gastric fluid in vitro. 

Based on the results of the allergenicity and toxicity studies, Monsanto concludes that the CP4 

EPSPS protein poses a negligible risk to human and animal health upon consumption. 

Evidence for Suppression of FATB1-A and FAD2-1A Genes 

Monsanto examined the expression of RNA from the endogenous FAD2-1A and FATB1-A genes 

by Northern hybridization analyses. The results of these analyses show that levels of transcripts 

of FATB1-A and FAD2-1A in immature seeds of soybean MON 87705 are significantly 

diminished in comparison with those from the control soybean (A3525). This decreased level of 

transcription confirms that the endogenous FATB1-A and FAD2-1A genes are functionally 

suppressed in soybean MON 87705. 

Food & Feed Uses of Soybean 

Soybean 

Monsanto describes historical and current uses of soybean in food and animal feed, and states 

that it intends to market soybean MON 87705 for these same purposes. Soybean seeds are 

processed primarily into oil and meal. Commodity soybean oil is rich in polyunsaturated fatty 

acids and is commonly used as a salad and cooking oil and in the production of margarine and 

other food ingredients. Monsanto states that soybean MON 87705 was developed to produce an 

oil with an unsaturated fatty acid profile more like olive oil or canola oil, while having lower 

levels of saturated fatty acids like commodity soybean oil. A small fraction of soybean meal is 
DRAFT MONSANTO 87705 SOYBEAN 

 5 

further processed into soy flours and soy proteins for a variety of food uses. Traditional foods 

prepared from soybeans include tofu, miso, soymilk, tempeh, and soy sauce. 

Soybean meal is the most common supplemental protein source in U.S. livestock and poultry 

rations due to its nutrient composition, availability, and price. Soybean meal is processed in 

moist heat to inactivate trypsin inhibitors and lectins, which are antinutrients occurring in raw 

soybeans. Although soybean and soybean-derived products have some use (~5%) in the 

manufacture of industrial products including soaps, inks, paints, disinfectants, and biodiesel, the 

food and feed uses of soybean and its processed products remain the predominant use of 

soybeans produced in the U.S. and globally. 

Composition

Scope of Analysis 

Monsanto analyzed the composition of forage and seed from soybean MON 87705 and the 

control soybean A3525 to assess whether the transgenic soybean is similar to non-transgenic 

soybeans except for the intended change in fatty acid composition. Monsanto also assessed the 

composition of forage and seed from a total of twenty conventional reference soybean varieties 

("reference varieties") grown under the same field conditions as soybeans MON 87705 and 

A3525. Monsanto used data derived from those 20 reference varieties to generate a 99% 

tolerance interval for each component.4

 Monsanto states that the data illustrate the natural 

variability in commercially grown soybean varieties. The compositional analysis included key 

nutrients and antinutrients. 

Study Design 

Monsanto states that soybean MON 87705, soybean A3525, and 20 conventional soybean 

varieties (four different conventional soybean varieties per site) were included in this study. 

However, one reference variety, damaged by an early frost, was excluded from the study. Seed 

and forage were obtained from soybeans grown in three replicated plots, planted in a randomized 

complete block design, at each of five field sites across Chile during the 2007/2008 growing 

season. Monsanto measured and evaluated 60 components in seed and seven in forage. Monsanto 

analyzed forage for crude protein, crude fat, moisture, ash, carbohydrates by calculation, acid 

detergent fiber (ADF), and neutral detergent fiber (NDF). Compositional analysis of seed 

included crude protein, crude fat, moisture, ash, carbohydrates by calculation, ADF, NDF, fatty 

acids (26: C8-C24), 18 amino acids, Vitamin E, isoflavones (daidzein, genistein, and glycitein), 

and antinutrients (phytic acid, trypsin inhibitor, lectin, raffinose, and stachyose). Of the measured 

components, 17 fatty acids in seed had more than 50% of the observations below the assay limit 

of quantitation and these components were not statistically analyzed. Thus, statistical analyses 

were conducted for 50 components (43 in seed and seven in forage). 

The data sets were assessed using a mixed model of variance. Six sets of statistical analyses were 

conducted, five based on the data from each of the replicated field sites (individual-site) and the 

sixth based on data from a combination of all five field sites (combined-site). Each individual 

component for soybean MON 87705 was compared with that of soybean A3525. Statistical 

significance was declared at 5% level (P ≤ 0.05). When a statistically significant difference in a 
DRAFT MONSANTO 87705 SOYBEAN 

 6 

component was detected between soybeans MON 87705 and A3525 in the combined-site 

comparison, an analysis was conducted to assess whether the difference was biologically 

meaningful from a food and feed safety or nutritional perspective. This analysis included 

reproducibility across individual sites, magnitude of differences, and comparisons of soybean 

MON 87705 mean component values to the 99% tolerance interval for the population of 

reference varieties (grown concurrently) and values in published literature and the International 

Life Sciences Institute Crop Composition Database (ILSI-CCD).5

Results of analyses:

Compositional analysis of soybean forage 

A significant difference between soybeans MON 87705 and A3525 was detected (P < 0.02) for 

ash. Monsanto reports that the mean ash level measured for both soybeans MON 87705 and 

A3525 falls within the 99% tolerance interval calculated by Monsanto for the reference varieties, 

and within the range of literature values for this component. Thus, Monsanto concludes that the 

difference in ash content is not biologically significant.

Compositional analysis of soybean seed 

For the combined-site analyses, a statistically significant difference between soybeans MON 

87705 and A3525 was detected (P < 0.048 and P < 0.043) for arginine and cystine (as % of dry 

weight (DW)). Monsanto reports that the mean arginine and cystine levels measured for both 

soybeans MON 87705 and A3525 fall within the 99% tolerance intervals calculated by 

Monsanto for the reference varieties and within the range of literature values. A significant 

difference between soybeans MON 87705 and A3525 was also detected (P < 0.001) for crude fat 

(% DW). Monsanto reports that the mean crude fat levels measured for both soybeans MON 

87705 and A3525 fall within the 99% tolerance interval calculated by Monsanto for the reference 

varieties and within the range of literature values. Monsanto concludes that the small differences 

in arginine, cystine, and total fat are not considered biologically meaningful for food and feed 

safety or nutrition. 

Intended Compositional Change - Fatty Acids 

Monsanto states that soybean MON 87705 was developed to produce soybean oil with higher 

levels of 18:1 oleic acid, an associated decrease in 18:2 linoleic acid and lower levels of 16:0 

palmitic and 18:0 stearic acids through suppression of FAD2 and FATB RNAs. Thus, Monsanto 

reports that there are statistically significant decreases in palmitic acid (P < 0.001) and linoleic 

acid (P < 0.001) and an increase in oleic acid (P < 0.001), which are associated with the intended 

effects of the change in this variety (Table 1). Monsanto states that although stearic acid levels 

are statistically lower in soybean MON 87705 when compared with soybean A3525, all values 

for soybeans MON 87705 and A3525 fall within the 99% tolerance interval calculated by 

Monsanto for the reference varieties and within the range of values in the ILSI database. The 

three remaining statistically significant differences in the combined-site analysis are 18:3 

linolenic, 20:0 arachidic, and 20:1 eicosenoic acids. The decrease in linolenic acid is expected, 

given that this fatty acid is produced from linoleic acid which is reduced by the suppression of 

the FAD2 gene. Although arachidic acid levels are statistically lower in soybean MON 87705 
DRAFT MONSANTO 87705 SOYBEAN 

 7 

when compared with soybean A3525, all values for soybeans MON 87705 and A3525 fall within 

the 99% tolerance interval calculated by Monsanto for the reference varieties. The mean level of 

eicosenoic acid in soybean MON 87705 is significantly higher than in soybean A3525 in the 

combined-site and all five individual-site analyses. However, the absolute magnitude of these 

differences is small (< 0.18% of total fatty acids). The combined-site mean for eicosenoic acid 

(0.34% of total fatty acids) is slightly (0.09% of total fatty acids) outside the upper end (0.25% of 

total FA) of the 99% tolerance interval, but within the values reported in the ILSI-CCD. 

Monsanto concludes that the small differences in linolenic, arachidic, and eicosenoic acids are 

not considered biologically meaningful for food and feed safety or nutrition. 

Table 1. Summary of Key Fatty Acid Levels in Soybean MON 87705 vs. its Isogenic Control 

(Soybean A3525) and Conventional Varieties 

Fatty Acid Soybean MON 

87705[Range] 

Control(Soybean 

A3525)[Range] 

Conventional Tolerance 

Intervala

16:0 

Palmitic 2.25-2.44 10.51-11.08 7.62, 12.55 

18:0 Stearic 3.07-3.82 4.24-4.85 2.87, 7.15 

18:1 Oleic 73.13-79.17 21.41-25.08 18.40, 30.22 

18:2 

Linoleic 7.85-12.42 51.68-53.89 47.75, 56.46 

a

A 99% tolerance interval represents, with 95% confidence, 99% of the values contained in a 

population of conventional soybean varieties grown at the same location as the test varieties. 

Compositional analysis of processed fractions (meal, oil, protein isolates, and lecithin) 

Seed from soybeans MON 87705 and A3525 were collected from two plots at each of two sites 

across the U.S. during the 2007 growing season. In addition, 12 conventional soybean varieties 

produced at three locations in separate U.S. field trials in 2007 were included for the generation 

of a 99% tolerance interval. A subsample of each soybean MON 87705, control soybean 

(A3525), and reference soybean seed was processed into toasted and defatted (TD) soybean 

meal, refined bleached and deodorized (RBD) oil, protein isolate, and crude lecithin. Seed and a 

subsample of the processed products from MON 87705, A3525, and the 12 conventional 

soybean varieties were analyzed for composition. In all, 27 components were analyzed in meal, 

39 in oil, 19 in protein isolates, and 4 in lecithin. The components in soybean meal included 

moisture, crude protein, crude fat, ash, carbohydrates by calculation, ADF, NDF, amino acids 

(18), phytic acid, and trypsin inhibitor. 

Oil samples were analyzed for fatty acids (38; C8-C24) and vitamin E. Of the measured 

components, 21 fatty acids in oil had more than 50% of the observations below the assay limit of 

quantitation and these components were not statistically analyzed. The components in protein 

isolates included amino acids (18) and moisture. The components in lecithin were L-αphosphatidic acid, L-α-phosphatidylcholine, L-α-phosphatidylethanolamine, and L-αphosphatidylinositol. 
DRAFT MONSANTO 87705 SOYBEAN 

 8 

Analyses of components in the processed product samples (meal, oil, protein isolates, and 

lecithin) show no statistically significant differences between soybeans MON 87705 and A3525 

for 49 of 68 comparisons. In soybean meal, significant differences were observed for alanine (P 

< 0.019), glycine (P < 0.023), isoleucine (P < 0.006), lysine (P < 0.030), valine (P < 0.003), and 

NDF (P < 0.016). For these five amino acids, the absolute magnitude of the mean differences 

from soybean A3525 were small (< 0.1% DW) and the mean values for soybeans MON 87705 

and A3525 fall within the 99% tolerance interval for the reference varieties and also within the 

range of published values for conventional soybean varieties. Monsanto reports that the mean 

NDF values measured for soybeans MON 87705 and A3525 fall within the 99% tolerance 

intervals for reference varieties and also within the range of published values for conventional 

soybean varieties. Of the 17 fatty acids that could be statistically analyzed, significant 

differences between soybeans MON 87705 and A3525 in RBD oil were observed for 13 fatty 

acids. Four of the 13 differences were expected as they were due to the intended changes in fatty 

acid levels as described above. For six of the remaining nine fatty acids (myristic, palmitoleic, 

margaric, arachidic, eicosenoic, and behenic acids), the absolute magnitude of the differences 

between the mean values for soybeans MON 87705 and A3525 is less than 0.15% of total fatty 

acids and the soybean MON 87705 mean values fall within the 99% tolerance intervals for the 

reference varieties. The three remaining fatty acids [17:1 9cis heptadecenoic acid, 18:2 other 

trans isomer fatty acids (excluding 9trans,12trans linoleic), and 18:2 6cis,9cis octadecadienoic 

acid] are minor components in RBD oil (< 0.2% of total fatty acids) and were found in the 

processed oil and not in the seed prior to being processed. There are no statistically significant 

differences (P < 0.05) between soybeans MON 87705 and A3525 for the components measured 

in the protein isolate and crude lecithin fractions. 

Monsanto states that the compositional and nutritional assessment supports the conclusion that, 

except for the intended changes in the levels of specific fatty acids, soybean MON 87705 is 

compositionally equivalent to conventional soybean varieties. Monsanto concludes that the 

small, but statistically significant, differences in the components mentioned above are not 

considered biologically meaningful for food and feed safety or nutrition. 

Endogenous Allergens 

Monsanto conducted a study to determine whether the transformation process may have 

increased the overall allergenicity of soybean MON 87705 compared to the conventional 

soybean variety. Using sera from clinically documented, soybean-allergic patients, Monsanto 

conducted immunoglobulin E (IgE) ELISA studies using protein extracts from soybeans MON 

87705 and A3525. Monsanto reports that soybean-specific IgE binding to endogenous allergens 

in soybeans MON 87705 and A3525 is comparable with the IgE binding to conventional 

soybeans currently on the market. Therefore, Monsanto concludes that soybean MON 87705 

does not pose an increased endogenous soybean allergen risk compared to conventional soybean 

varieties. 

Fatty Acid Intake 

Human Diet 
DRAFT MONSANTO 87705 SOYBEAN 

 9 

Monsanto generated estimates of dietary exposure to various fatty acids from the consumption of 

oil from soybean MON 87705. Monsanto concludes that based on conservative intake estimates 

calculated on the assumption that oil from soybean MON 87705 would replace soybean oil 

currently used in a subset of targeted foods, the intake of oleic acid would increase, while the 

intakes of palmitic and linoleic acids would decrease and the total fat intake would not be 

affected. Since humans consume oils from a variety of sources, Monsanto concludes that 

consumption of oil from soybean MON 87705 will not affect the human diet. 

Animal Diets 

When oil is removed from the soybean, a defatted meal is generated that is used as a protein 

supplement for animal feed. In an amendment dated January 21, 2010, Monsanto provided 

examples of poultry and swine diets to demonstrate that the reduced intake of linoleic acid would 

not lead to a nutritional deficiency for animals consuming feeds containing meal derived from 

soybean MON 87705. Even though meal derived from soybean MON 87705 would have reduced 

amounts of linoleic acid, Monsanto states that the animals’ linoleic acid requirements would be 

easily met by other ingredients that would be included in the diet, such as corn. 

Common or Usual Name of the Oil Product 

Based on the intended change in fatty acid composition, it is our understanding that Monsanto 

has concluded that the common or usual name “high oleic soybean oil” is appropriate to 

distinguish oil from soybean MON 87705 from that of conventional soybean varieties. 

Conclusion 

Monsanto has concluded that, with the exception of the intended change in fatty acid 

composition, soybean MON 87705 and the foods and feeds derived from it are not materially 

different in composition, safety, or any other relevant parameter from other soybean varieties 

now grown, marketed, and consumed in the U.S. At this time, based on Monsanto’s data and 

information, the agency considers Monsanto’s consultation on soybean MON 87705 to be 

complete. 

Shayla West-Barnette, Ph.D.

1

The analytical techniques discussed in the submission include N-terminal sequence analysis, mass determination of 

the tryptic peptides by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF 

MS), sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), Western hybridization analysis, CP4 

EPSPS enzymatic activity analysis, and glycosylation analysis. 

2

The E-score was set at < 1 x 10-5 to ensure that sequences have sufficient sequence similarity to infer homology. 

3

These criteria can be found in the guidelines for the evaluation of the potential allergenicity of introduced proteins, 

published in 2003 by the Codex Alimentarius Commission. 

4

A 99% tolerance interval represents, with 95% confidence, 99% of the values contained in the population of 

conventional soybean varieties. 

5

Monsanto used version 3.0 (accessed on 8-27-06) of the ILSI-CCD in its analysis. The database is maintained by 

ILSI and can be accessed at http://www.cropcomposition.org/. 
APPENDIX B 

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 premarket 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. 

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 plant3 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 

toxins4? 

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)5. 

4. Does the pest resistance6

 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). 

 

3

 APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to the TES plant 

4

 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. 

5

 Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, aluminum or heavy 

metals. 

6

 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. 
For the biotechnologist: 

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. 

 
APPENDIX C 

THREATENED AND ENDANGERED SPECIES STATE LISTS 

Alabama (US-FWS, 2011a) 

Animals – 103 Listings 

Status Species 

E Acornshell, southern (Epioblasma othcaloogensis) 

T Bankclimber, purple (mussel) (Elliptoideus sloatianus) 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bean, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations (Villosa 

trabalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Blossom, tubercled (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Epioblasma torulosa torulosa) 

E Blossom, turgid (pearlymussel) Entire Range; Except where listed as Experimental Populations (Epioblasma 

turgidula) 

E Blossom, yellow (pearlymussel) Entire Range; Except where listed as Experimental Populations (Epioblasma 

florentina florentina) 

E Butterfly, Mitchell's satyr (Neonympha mitchellii mitchellii) 

E Campeloma, slender (Campeloma decampi) 

E Cavefish, Alabama (Speoplatyrhinus poulsoni) 

T Chub, spotfin Entire (Erimonax monachus) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Clubshell, black (Pleurobema curtum) 

E Clubshell, ovate (Pleurobema perovatum) 

E Clubshell, southern (Pleurobema decisum) 

E Combshell, Cumberlandian Entire Range; Except where listed as Experimental Populations (Epioblasma 

brevidens) 

E Combshell, southern (Epioblasma penita) 

E Combshell, upland (Epioblasma metastriata) 

E Darter, amber (Percina antesella) 

E Darter, boulder (Etheostoma wapiti) 

T Darter, goldline (Percina aurolineata) 

T Darter, slackwater (Etheostoma boschungi) 

T Darter, snail (Percina tanasi) 

E Darter, vermilion (Etheostoma chermocki) 

E Darter, watercress (Etheostoma nuchale) 

T Elimia, lacy (snail) (Elimia crenatella) 

E Fanshell (Cyprogenia stegaria) 

E Frog, Mississippi gopher Wherever found west of Mobile and Tombigbee Rivers in AL, MS, and LA (Rana 

capito sevosa) 

T Heelsplitter, Alabama (=inflated) (Potamilus inflatus) 

E Hornsnail, rough (Pleurocera foremani) 

E Kidneyshell, triangular (Ptychobranchus greenii) 
Status Species 

E Lampmussel, Alabama Entire Range; Except where listed as Experimental Populations (Lampsilis virescens)

E Lilliput, pale (pearlymussel) (Toxolasma cylindrellus) 

E Lioplax, cylindrical (snail) (Lioplax cyclostomaformis) 

E Manatee, West Indian (Trichechus manatus) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

T Moccasinshell, Alabama (Medionidus acutissimus) 

E Moccasinshell, Coosa (Medionidus parvulus) 

E Moccasinshell, Gulf (Medionidus penicillatus) 

E Monkeyface, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Quadrula intermedia) 

E Mouse, Alabama beach (Peromyscus polionotus ammobates) 

E Mouse, Perdido Key beach (Peromyscus polionotus trissyllepsis) 

T Mucket, orangenacre (Lampsilis perovalis) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, oyster Entire Range; Except where listed as Experimental Populations (Epioblasma capsaeformis) 

E Mussel, scaleshell (Leptodea leptodon) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pearlymussel, dromedary Entire Range; Except where listed as Experimental Populations (Dromus dromas) 

E Pearlymussel, littlewing (Pegias fabula) 

E Pebblesnail, flat (Lepyrium showalteri) 

E Pigtoe, dark (Pleurobema furvum) 

E Pigtoe, finerayed Entire Range; Except where listed as Experimental Populations (Fusconaia cuneolus) 

E Pigtoe, flat (Pleurobema marshalli) 

E Pigtoe, Georgia (Pleurobema hanleyianum) 

E Pigtoe, heavy (Pleurobema taitianum) 

E Pigtoe, oval (Pleurobema pyriforme) 

E Pigtoe, rough (Pleurobema plenum) 

E Pigtoe, shiny Entire Range; Except where listed as Experimental Populations (Fusconaia cor) 

E Pigtoe, southern (Pleurobema georgianum) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

T Pocketbook, finelined (Lampsilis altilis) 

E Pocketbook, shinyrayed (Lampsilis subangulata) 

E purple cat's paw (=purple cat's paw pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma obliquata obliquata) 

E Riffleshell, tan (Epioblasma florentina walkeri (=E. walkeri)) 

E Ring pink (mussel) (Obovaria retusa) 

E Riversnail, Anthony's Entire Range; Except where listed as Experimental Populations (Athearnia anthonyi) 

E Rocksnail, interrupted (=Georgia) (Leptoxis foremani) 

T Rocksnail, painted (Leptoxis taeniata) 

E Rocksnail, plicate (Leptoxis plicata) 

T Rocksnail, round (Leptoxis ampla) 

T Salamander, frosted flatwoods (Ambystoma cingulatum) 

T Salamander, Red Hills (Phaeognathus hubrichti) 

E Sawfish, smalltooth (Pristis pectinata) 
Status Species 

T Sculpin, pygmy (Cottus paulus (=pygmaeus)) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

T Shiner, blue (Cyprinella caerulea) 

E Shiner, Cahaba (Notropis cahabae) 

E Shiner, palezone (Notropis albizonatus) 

E Shrimp, Alabama cave (Palaemonias alabamae) 

T Slabshell, Chipola (Elliptio chipolaensis) 

E Snail, armored (Pyrgulopsis (=Marstonia) pachyta) 

E Snail, tulotoma (Tulotoma magnifica) 

T Snake, eastern indigo (Drymarchon corais couperi) 

E Stirrupshell (Quadrula stapes) 

E Stork, wood AL, FL, GA, SC (Mycteria americana) 

E Sturgeon, Alabama (Scaphirhynchus suttkusi) 

T Sturgeon, gulf (Acipenser oxyrinchus desotoi) 

T Tortoise, gopher W of of Mobile/Tombigbee Rs. (Gopherus polyphemus) 

E Turtle, Alabama red-belly (Pseudemys alabamensis) 

T Turtle, flattened musk species range clarified (Sternotherus depressus) 

E Wartyback, white (pearlymussel) (Plethobasus cicatricosus) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 19 listings 

Status Species 

T Amphianthus, little (Amphianthus pusillus) 

T Bladderpod, lyrate (Lesquerella lyrata) 

T Button, Mohr's Barbara (Marshallia mohrii) 

E Chaffseed, American (Schwalbea americana) 

T Fern, Alabama streak-sorus (Thelypteris pilosa var. alabamensis) 

T Fern, American hart's-tongue (Asplenium scolopendrium var. americanum) 

E Grass, Tennessee yellow-eyed (Xyris tennesseensis) 

E Harperella (Ptilimnium nodosum) 

E Leather flower, Alabama (Clematis socialis) 

E Leather flower, Morefield's (Clematis morefieldii) 

E Pinkroot, gentian (Spigelia gentianoides) 

E Pitcher-plant, Alabama canebrake (Sarracenia rubra alabamensis) 

E Pitcher-plant, green (Sarracenia oreophila) 

E Pondberry (Lindera melissifolia) 

T Potato-bean, Price's (Apios priceana) 

E Prairie-clover, leafy (Dalea foliosa) 
Status Species 

E Quillwort, Louisiana (Isoetes louisianensis) 

E Trillium, relict (Trillium reliquum) 

T Water-plantain, Kral's (Sagittaria secundifolia) 

Arkansas (US-FWS, 2011b) 

Animals – 25 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bat, Ozark big-eared (Corynorhinus (=Plecotus) townsendii ingens) 

E Beetle, American burying (Nicrophorus americanus) 

E Blossom, turgid (pearlymussel) Entire Range; Except where listed as Experimental Populations (Epioblasma 

turgidula) 

T Cavefish, Ozark (Amblyopsis rosae) 

E Crayfish, cave (Cambarus aculabrum) 

E Crayfish, cave (Cambarus zophonastes) 

T Darter, leopard (Percina pantherina) 

T fatmucket, Arkansas (Lampsilis powellii) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, scaleshell (Leptodea leptodon) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Pearlymussel, Curtis (Epioblasma florentina curtisii) 

E Pocketbook, fat (Potamilus capax) 

E Pocketbook, Ouachita rock (Arkansia wheeleri) 

E Pocketbook, speckled (Lampsilis streckeri) 

T Shagreen, Magazine Mountain (Mesodon magazinensis) 

T Shiner, Arkansas River Arkansas R. Basin (Notropis girardi) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Woodpecker, ivory-billed entire (Campephilus principalis) 

E Woodpecker, red-cockaded (Picoides borealis) 

Plants – 6 listings 

Status Species 

T bladderpod, Missouri (Physaria filiformis) 

E Clover, running buffalo (Trifolium stoloniferum) 

E Harperella (Ptilimnium nodosum) 

T Geocarpon minimum (No common name) 

T Orchid, eastern prairie fringed (Platanthera leucophaea)
Status Species 

E Pondberry (Lindera melissifolia) 

Delaware (US-FWS, 2011c) 

Animals – 16 listings 

Status Species 

E Beetle, American burying (Nicrophorus americanus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Squirrel, Delmarva Peninsula fox Entire, except Sussex Co., DE (Sciurus niger cinereus) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

T Turtle, bog (=Muhlenberg) northern (Clemmys muhlenbergii) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 7 listings

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

T Beaked-rush, Knieskern's (Rhynchospora knieskernii)

E Chaffseed, American (Schwalbea americana) 

E Dropwort, Canby's (Oxypolis canbyi) 

T Joint-vetch, sensitive (Aeschynomene virginica) 

T Pink, swamp (Helonias bullata) 

T Pogonia, small whorled (Isotria medeoloides) 

Florida (US-FWS, 2011d) 

Animals – 61 listings 

Status Species 

T Bankclimber, purple (mussel) (Elliptoideus sloatianus) 

E Bat, gray (Myotis grisescens) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Schaus swallowtail (Heraclides aristodemus ponceanus) 

T Caracara, Audubon's crested FL pop. (Polyborus plancus audubonii) 

T Coral, elkhorn (Acropora palmata) 
Status Species 

T Coral, staghorn (Acropora cervicornis) 

T Crocodile, American FL pop. (Crocodylus acutus) 

E Darter, Okaloosa (Etheostoma okaloosae) 

E Deer, key (Odocoileus virginianus clavium) 

E Kite, Everglade snail FL pop. (Rostrhamus sociabilis plumbeus) 

E Manatee, West Indian (Trichechus manatus) 

E Moccasinshell, Gulf (Medionidus penicillatus) 

E Moccasinshell, Ochlockonee (Medionidus simpsonianus) 

E Mouse, Anastasia Island beach (Peromyscus polionotus phasma) 

E Mouse, Choctawhatchee beach (Peromyscus polionotus allophrys) 

E Mouse, Key Largo cotton (Peromyscus gossypinus allapaticola) 

E Mouse, Perdido Key beach (Peromyscus polionotus trissyllepsis) 

T Mouse, southeastern beach (Peromyscus polionotus niveiventris) 

E Mouse, St. Andrew beach (Peromyscus polionotus peninsularis) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Pigtoe, oval (Pleurobema pyriforme) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Pocketbook, shinyrayed (Lampsilis subangulata) 

E Rabbit, Lower Keys marsh (Sylvilagus palustris hefneri) 

E Rice rat lower FL Keys (Oryzomys palustris natator) 

T Salamander, frosted flatwoods (Ambystoma cingulatum) 

E salamander, Reticulated flatwoods (Ambystoma bishopi) 

E Sawfish, smalltooth (Pristis pectinata) 

T scrub-jay, Florida (Aphelocoma coerulescens) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, green FL, Mexico nesting pops. (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Seal, Caribbean monk (Monachus tropicalis) 

T Shrimp, Squirrel Chimney Cave (Palaemonetes cummingi) 

T Skink, bluetail mole (Eumeces egregius lividus) 

T Skink, sand (Neoseps reynoldsi) 

T Slabshell, Chipola (Elliptio chipolaensis) 

T Snail, Stock Island tree (Orthalicus reses (not incl. nesodryas)) 

T Snake, Atlantic salt marsh (Nerodia clarkii taeniata) 

T Snake, eastern indigo (Drymarchon corais couperi) 

E Sparrow, Cape Sable seaside (Ammodramus maritimus mirabilis) 

E Sparrow, Florida grasshopper (Ammodramus savannarum floridanus) 

E Stork, wood AL, FL, GA, SC (Mycteria americana) 

T Sturgeon, gulf (Acipenser oxyrinchus desotoi) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

T Tern, roseate Western Hemisphere except NE U.S. (Sterna dougallii dougallii) 

E Three-ridge, fat (mussel) (Amblema neislerii) 

E Vole, Florida salt marsh (Microtus pennsylvanicus dukecampbelli) 
Status Species 

E Warbler (=wood), Bachman's (Vermivora bachmanii) 

E Warbler, Kirtland's (Dendroica kirtlandii) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus)

E Wolf, red except where EXPN (Canis rufus) 

E Woodpecker, red-cockaded (Picoides borealis) 

E Woodrat, Key Largo (Neotoma floridana smalli) 

Plants – 55 listings 

Status Species 

E Aster, Florida golden (Chrysopsis floridana) 

E Beargrass, Britton's (Nolina brittoniana) 

E Beauty, Harper's (Harperocallis flava) 

E Bellflower, Brooksville (Campanula robinsiae) 

T Birds-in-a-nest, white (Macbridea alba) 

E Blazingstar, scrub (Liatris ohlingerae) 

T Bonamia, Florida (Bonamia grandiflora) 

T Buckwheat, scrub (Eriogonum longifolium var. gnaphalifolium) 

T Butterwort, Godfrey's (Pinguicula ionantha) 

E Cactus, Key tree (Pilosocereus robinii) 

E Campion, fringed (Silene polypetala) 

E Chaffseed, American (Schwalbea americana) 

E Cladonia, Florida perforate (Cladonia perforata) 

E Fringe-tree, pygmy (Chionanthus pygmaeus) 

T Gooseberry, Miccosukee (Ribes echinellum) 

E Gourd, Okeechobee (Cucurbita okeechobeensis ssp. okeechobeensis)

E Harebells, Avon Park (Crotalaria avonensis) 

E Hypericum, highlands scrub (Hypericum cumulicola) 

E Jacquemontia, beach (Jacquemontia reclinata) 

E Lead-plant, Crenulate (Amorpha crenulata) 

E Lupine, scrub (Lupinus aridorum) 

E Meadowrue, Cooley's (Thalictrum cooleyi) 

E Milkpea, Small's (Galactia smallii) 

E Mint, Garrett's (Dicerandra christmanii) 

E Mint, Lakela's (Dicerandra immaculata) 

E Mint, longspurred (Dicerandra cornutissima) 

E Mint, scrub (Dicerandra frutescens) 

E Mustard, Carter's (Warea carteri) 

E Pawpaw, beautiful (Deeringothamnus pulchellus) 

E Pawpaw, four-petal (Asimina tetramera) 

E Pawpaw, Rugel's (Deeringothamnus rugelii) 

T Pigeon wings (Clitoria fragrans) 
Status Species 

E Pinkroot, gentian (Spigelia gentianoides) 

E Plum, scrub (Prunus geniculata) 

E Polygala, Lewton's (Polygala lewtonii) 

E Polygala, tiny (Polygala smallii) 

E Pondberry (Lindera melissifolia) 

E Prickly-apple, fragrant (Cereus eriophorus var. fragrans) 

E Rhododendron, Chapman (Rhododendron chapmanii) 

E Rosemary, Apalachicola (Conradina glabra) 

E Rosemary, Etonia (Conradina etonia) 

E Rosemary, short-leaved (Conradina brevifolia) 

E Sandlace (Polygonella myriophylla) 

T Seagrass, Johnson's (Halophila johnsonii) 

T Skullcap, Florida (Scutellaria floridana) 

E Snakeroot (Eryngium cuneifolium) 

E Spurge, deltoid (Chamaesyce deltoidea ssp. deltoidea) 

T Spurge, Garber's (Chamaesyce garberi) 

T Spurge, telephus (Euphorbia telephioides) 

E Torreya, Florida (Torreya taxifolia) 

E Warea, wide-leaf (Warea amplexifolia) 

E Water-willow, Cooley's (Justicia cooleyi) 

T Whitlow-wort, papery (Paronychia chartacea) 

E Wireweed (Polygonella basiramia) 

E Ziziphus, Florida (Ziziphus celata) 

Georgia (US-FWS, 2011e) 

Animals – 53 listings 

Status Species 

E Acornshell, southern (Epioblasma othcaloogensis) 

T Bankclimber, purple (mussel) (Elliptoideus sloatianus) 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

T Chub, spotfin Entire (Erimonax monachus) 

E Clubshell, ovate (Pleurobema perovatum) 

E Clubshell, southern (Pleurobema decisum) 

E Combshell, upland (Epioblasma metastriata) 

E Darter, amber (Percina antesella) 

T Darter, Cherokee (Etheostoma scotti) 

E Darter, Etowah (Etheostoma etowahae) 

T Darter, goldline (Percina aurolineata) 

T Darter, snail (Percina tanasi) 

E Hornsnail, rough (Pleurocera foremani) 

E Kidneyshell, triangular (Ptychobranchus greenii) 

E Lioplax, cylindrical (snail) (Lioplax cyclostomaformis) 
Status Species 

E Logperch, Conasauga (Percina jenkinsi) 

E Manatee, West Indian (Trichechus manatus) 

T Moccasinshell, Alabama (Medionidus acutissimus) 

E Moccasinshell, Coosa (Medionidus parvulus) 

E Moccasinshell, Gulf (Medionidus penicillatus) 

E Moccasinshell, Ochlockonee (Medionidus simpsonianus) 

E Mussel, oyster Entire Range; Except where listed as Experimental Populations (Epioblasma capsaeformis)

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Pigtoe, Georgia (Pleurobema hanleyianum) 

E Pigtoe, oval (Pleurobema pyriforme) 

E Pigtoe, southern (Pleurobema georgianum) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

T Pocketbook, finelined (Lampsilis altilis) 

E Pocketbook, shinyrayed (Lampsilis subangulata) 

E Riversnail, Anthony's Entire Range; Except where listed as Experimental Populations (Athearnia anthonyi)

E Rocksnail, interrupted (=Georgia) (Leptoxis foremani) 

T Salamander, frosted flatwoods (Ambystoma cingulatum) 

E salamander, Reticulated flatwoods (Ambystoma bishopi) 

E Sawfish, smalltooth (Pristis pectinata) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

T Shiner, blue (Cyprinella caerulea) 

T Snake, eastern indigo (Drymarchon corais couperi) 

E Stork, wood AL, FL, GA, SC (Mycteria americana) 

T Sturgeon, gulf (Acipenser oxyrinchus desotoi) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

T Tern, roseate Western Hemisphere except NE U.S. (Sterna dougallii dougallii) 

E Three-ridge, fat (mussel) (Amblema neislerii) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Woodpecker, red-cockaded (Picoides borealis) 

Plants – 24 listings 

Status Species 

T Amphianthus, little (Amphianthus pusillus) 

T Button, Mohr's Barbara (Marshallia mohrii) 

E Campion, fringed (Silene polypetala) 

E Chaffseed, American (Schwalbea americana) 

E Coneflower, smooth (Echinacea laevigata) 
Status Species 

E Dropwort, Canby's (Oxypolis canbyi) 

E Grass, Tennessee yellow-eyed (Xyris tennesseensis)

E Harperella (Ptilimnium nodosum) 

E Leather flower, Alabama (Clematis socialis) 

E Meadowrue, Cooley's (Thalictrum cooleyi) 

T Pink, swamp (Helonias bullata) 

E Pitcher-plant, green (Sarracenia oreophila) 

T Pogonia, small whorled (Isotria medeoloides) 

E Pondberry (Lindera melissifolia) 

E Quillwort, black spored (Isoetes melanospora) 

E Quillwort, mat-forming (Isoetes tegetiformans) 

E Rattleweed, hairy (Baptisia arachnifera) 

T Skullcap, large-flowered (Scutellaria montana) 

T Spiraea, Virginia (Spiraea virginiana) 

E Sumac, Michaux's (Rhus michauxii) 

E Torreya, Florida (Torreya taxifolia) 

E Trillium, persistent (Trillium persistens) 

E Trillium, relict (Trillium reliquum) 

T Water-plantain, Kral's (Sagittaria secundifolia) 

Illinois (US-FWS, 2011f) 

Animals – 26 listings 

Status Species 

E Amphipod, Illinois cave (Gammarus acherondytes) 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Blossom, tubercled (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Epioblasma torulosa torulosa) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Dragonfly, Hine's emerald (Somatochlora hineana) 

E Fanshell (Cyprogenia stegaria) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, scaleshell (Leptodea leptodon) 

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Pocketbook, fat (Potamilus capax) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E purple cat's paw (=purple cat's paw pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma obliquata obliquata) 
Status Species 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

E Ring pink (mussel) (Obovaria retusa) 

E Snail, Iowa Pleistocene (Discus macclintocki) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wartyback, white (pearlymussel) (Plethobasus cicatricosus) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 10 listings 

Status Species 

T Aster, decurrent false (Boltonia decurrens) 

T Bush-clover, prairie (Lespedeza leptostachya) 

E Clover, running buffalo (Trifolium stoloniferum) 

T Daisy, lakeside (Hymenoxys herbacea) 

T Milkweed, Mead's (Asclepias meadii) 

T Orchid, eastern prairie fringed (Platanthera leucophaea)

T Pogonia, small whorled (Isotria medeoloides) 

T Potato-bean, Price's (Apios priceana) 

E Prairie-clover, leafy (Dalea foliosa) 

T Thistle, Pitcher's (Cirsium pitcheri) 

Indiana (US-FWS, 2011g) 

Animals – 26 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Butterfly, Mitchell's satyr (Neonympha mitchellii mitchellii) 

E Catspaw, white (pearlymussel) (Epioblasma obliquata perobliqua) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Dragonfly, Hine's emerald (Somatochlora hineana) 

E Fanshell (Cyprogenia stegaria) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, scaleshell (Leptodea leptodon) 

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pigtoe, rough (Pleurobema plenum) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Pocketbook, fat (Potamilus capax) 
Status Species 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E purple cat's paw (=purple cat's paw pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma obliquata obliquata) 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

E Ring pink (mussel) (Obovaria retusa) 

T Snake, copperbelly water Indiana north of 40 degrees north latitude, Michigan, Ohio (Nerodia erythrogaster 

neglecta) 

E Tern, least interior pop. (Sterna antillarum) 

E Wartyback, white (pearlymussel) (Plethobasus cicatricosus) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 5 listings 

Status Species 

E Clover, running buffalo (Trifolium stoloniferum) 

T Milkweed, Mead's (Asclepias meadii) 

T Orchid, eastern prairie fringed (Platanthera leucophaea)

T Thistle, Pitcher's (Cirsium pitcheri) 

E Goldenrod, Short's (Solidago shortii) 

Iowa (US-FWS, 2011h) 

Animals – 13 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Shiner, Topeka (Notropis topeka (=tristis)) 

E Snail, Iowa Pleistocene (Discus macclintocki) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Beetle, American burying (Nicrophorus americanus) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mussel, scaleshell (Leptodea leptodon) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

E Pocketbook, fat (Potamilus capax) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 5 listings 

Status Species 

T Bush-clover, prairie (Lespedeza leptostachya) 

T Milkweed, Mead's (Asclepias meadii) 
Status Species 

T Monkshood, northern wild (Aconitum noveboracense) 

T Orchid, eastern prairie fringed (Platanthera leucophaea)

T Orchid, western prairie fringed (Platanthera praeclara)

Kansas (US-FWS, 2011i) 

Animals – 13 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Crane, whooping except where EXPN (Grus americana) 

E Curlew, Eskimo (Numenius borealis) 

E Ferret, black-footed entire population, except where EXPN (Mustela nigripes) 

T Madtom, Neosho (Noturus placidus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

T Shiner, Arkansas River Arkansas R. Basin (Notropis girardi) 

E Shiner, Topeka (Notropis topeka (=tristis)) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 3 listings 

Status Species 

T Milkweed, Mead's (Asclepias meadii) 

T Orchid, western prairie fringed (Platanthera praeclara)

E Clover, running buffalo (Trifolium stoloniferum) 

Kentucky (US-FWS, 2011j) 

Animals – 35 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bat, Virginia big-eared (Corynorhinus (=Plecotus) townsendii virginianus) 

E Bean, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations (Villosa 

trabalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Blossom, tubercled (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Epioblasma torulosa torulosa) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Combshell, Cumberlandian Entire Range; Except where listed as Experimental Populations (Epioblasma 
Status Species 

brevidens) 

T Dace, blackside (Phoxinus cumberlandensis) 

E Darter, duskytail Entire (Etheostoma percnurum) 

E Darter, relict (Etheostoma chienense) 

E Elktoe, Cumberland (Alasmidonta atropurpurea) 

E Fanshell (Cyprogenia stegaria) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, oyster Entire Range; Except where listed as Experimental Populations (Epioblasma capsaeformis) 

E Mussel, scaleshell (Leptodea leptodon) 

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pearlymussel, dromedary Entire Range; Except where listed as Experimental Populations (Dromus dromas) 

E Pearlymussel, littlewing (Pegias fabula) 

E Pigtoe, rough (Pleurobema plenum) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Pocketbook, fat (Potamilus capax) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E purple cat's paw (=purple cat's paw pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma obliquata obliquata) 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

E Riffleshell, tan (Epioblasma florentina walkeri (=E. walkeri)) 

E Ring pink (mussel) (Obovaria retusa) 

E Shiner, palezone (Notropis albizonatus) 

E Shrimp, Kentucky cave (Palaemonias ganteri) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wartyback, white (pearlymussel) (Plethobasus cicatricosus) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 8 listings 

Status Species 

E Clover, running buffalo (Trifolium stoloniferum) 

E Goldenrod, Short's (Solidago shortii) 

T Goldenrod, white-haired (Solidago albopilosa) 

T Potato-bean, Price's (Apios priceana) 

E Rock-cress, Braun's (Arabis perstellata) 

T Rosemary, Cumberland (Conradina verticillata) 

E Sandwort, Cumberland (Arenaria cumberlandensis)

T Spiraea, Virginia (Spiraea virginiana) 

Louisiana (US-FWS, 2011k) 

Animals – 26 listings 
Status Species 

T Bear, Louisiana black (Ursus americanus luteolus) 

T Heelsplitter, Alabama (=inflated) (Potamilus inflatus) 

E Manatee, West Indian (Trichechus manatus) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

T Pearlshell, Louisiana (Margaritifera hembeli) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

T Sturgeon, gulf (Acipenser oxyrinchus desotoi) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

T Tortoise, gopher W of of Mobile/Tombigbee Rs. (Gopherus polyphemus) 

T Turtle, ringed map (Graptemys oculifera) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Woodpecker, red-cockaded (Picoides borealis) 

E Beetle, American burying (Nicrophorus americanus) 

E Frog, Mississippi gopher Wherever found west of Mobile and Tombigbee Rivers in AL, MS, and LA (Rana 

capito sevosa) 

E Jaguar (Panthera onca) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Pocketbook, fat (Potamilus capax) 

E Sawfish, smalltooth (Pristis pectinata) 

Plants – 4 listings 

Status Species 

E Chaffseed, American (Schwalbea americana) 

T Geocarpon minimum (No common name) 

E Quillwort, Louisiana (Isoetes louisianensis) 

E Pondberry (Lindera melissifolia) 

 
Maryland (US-FWS, 2011l) 

Animals – 20 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Darter, Maryland (Etheostoma sellare) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Squirrel, Delmarva Peninsula fox Entire, except Sussex Co., DE (Sciurus niger cinereus) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

T Tiger beetle, northeastern beach (Cicindela dorsalis dorsalis) 

T Tiger beetle, Puritan (Cicindela puritana) 

T Turtle, bog (=Muhlenberg) northern (Clemmys muhlenbergii) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Beetle, American burying (Nicrophorus americanus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 10 listings 

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

E Bulrush, Northeastern (Scirpus ancistrochaetus) 

E Dropwort, Canby's (Oxypolis canbyi) 

E Gerardia, sandplain (Agalinis acuta) 

E Harperella (Ptilimnium nodosum) 

T Joint-vetch, sensitive (Aeschynomene virginica) 

T Pink, swamp (Helonias bullata) 

E Chaffseed, American (Schwalbea americana) 

E Coneflower, smooth (Echinacea laevigata) 

T Pogonia, small whorled (Isotria medeoloides) 

 
Michigan (US-FWS, 2011m) 

Animals – 15 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Beetle, Hungerford's crawling water (Brychius hungerfordi) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Butterfly, Mitchell's satyr (Neonympha mitchellii mitchellii) 

E Catspaw, white (pearlymussel) (Epioblasma obliquata perobliqua) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Dragonfly, Hine's emerald (Somatochlora hineana) 

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

T Snake, copperbelly water Indiana north of 40 degrees north latitude, Michigan, Ohio (Nerodia erythrogaster 

neglecta) 

E Warbler, Kirtland's (Dendroica kirtlandii) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 9 listings 

Status Species 

E Chaffseed, American (Schwalbea americana) 

T Daisy, lakeside (Hymenoxys herbacea) 

T Fern, American hart's-tongue (Asplenium scolopendrium var. americanum)

T Goldenrod, Houghton's (Solidago houghtonii) 

T Iris, dwarf lake (Iris lacustris) 

E monkey-flower, Michigan (Mimulus michiganensis) 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Pogonia, small whorled (Isotria medeoloides) 

T Thistle, Pitcher's (Cirsium pitcheri) 

Minnesota (US-FWS, 2011n) 

Animals – 11 listings 

Status Species 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Shiner, Topeka (Notropis topeka (=tristis)) 
Status Species 

T Wolf, gray MN (Canis lupus) 

E Beetle, American burying (Nicrophorus americanus) 

E Mussel, scaleshell (Leptodea leptodon) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 4 listings 

Status Species 

T Bush-clover, prairie (Lespedeza leptostachya) 

E Lily, Minnesota dwarf trout (Erythronium propullans) 

T Orchid, western prairie fringed (Platanthera praeclara)

T roseroot, Leedy's (Rhodiola integrifolium ssp. leedyi) 

Mississippi (US-FWS, 2011o) 

Animals – 41 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

T Bear, Louisiana black (Ursus americanus luteolus) 

E Beetle, American burying (Nicrophorus americanus) 

E Clubshell, black (Pleurobema curtum) 

E Clubshell, ovate (Pleurobema perovatum) 

E Clubshell, southern (Pleurobema decisum) 

E Combshell, Cumberlandian Entire Range; Except where listed as Experimental Populations (Epioblasma 

brevidens) 

E Combshell, southern (Epioblasma penita) 

E Crane, Mississippi sandhill (Grus canadensis pulla) 

T Darter, bayou (Etheostoma rubrum) 

E Frog, Mississippi gopher Wherever found west of Mobile and Tombigbee Rivers in AL, MS, and LA (Rana 

capito sevosa) 

T Heelsplitter, Alabama (=inflated) (Potamilus inflatus) 

E Manatee, West Indian (Trichechus manatus) 

T Moccasinshell, Alabama (Medionidus acutissimus) 

T Mucket, orangenacre (Lampsilis perovalis) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Pigtoe, flat (Pleurobema marshalli) 

E Pigtoe, heavy (Pleurobema taitianum) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Pocketbook, fat (Potamilus capax) 

E Sawfish, smalltooth (Pristis pectinata) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 
Status Species 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

T Snake, eastern indigo (Drymarchon corais couperi) 

E Stirrupshell (Quadrula stapes) 

E Stork, wood AL, FL, GA, SC (Mycteria americana) 

E Sturgeon, Alabama (Scaphirhynchus suttkusi) 

T Sturgeon, gulf (Acipenser oxyrinchus desotoi) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

T Tortoise, gopher W of of Mobile/Tombigbee Rs. (Gopherus polyphemus) 

E Turtle, Alabama red-belly (Pseudemys alabamensis) 

T Turtle, ringed map (Graptemys oculifera) 

T Turtle, yellow-blotched map (Graptemys flavimaculata) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Woodpecker, red-cockaded (Picoides borealis) 

Plants – 4 listings 

Status Species 

E Chaffseed, American (Schwalbea americana)

E Pondberry (Lindera melissifolia) 

T Potato-bean, Price's (Apios priceana) 

E Quillwort, Louisiana (Isoetes louisianensis) 

Missouri (US-FWS, 2011p) 

Animals – 21 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bat, Ozark big-eared (Corynorhinus (=Plecotus) townsendii ingens) 

E Beetle, American burying (Nicrophorus americanus) 

T Cavefish, Ozark (Amblyopsis rosae) 

E Cavesnail, Tumbling Creek (Antrobia culveri) 

T Darter, Niangua (Etheostoma nianguae) 

E Dragonfly, Hine's emerald (Somatochlora hineana) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

T Madtom, Neosho (Noturus placidus) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, scaleshell (Leptodea leptodon) 

E Pearlymussel, Curtis (Epioblasma florentina curtisii) 
Status Species 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Pocketbook, fat (Potamilus capax) 

E Shiner, Topeka (Notropis topeka (=tristis)) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Woodpecker, red-cockaded (Picoides borealis) 

Plants – 10 listings 

Status Species 

T Aster, decurrent false (Boltonia decurrens) 

T bladderpod, Missouri (Physaria filiformis) 

E Clover, running buffalo (Trifolium stoloniferum) 

T Milkweed, Mead's (Asclepias meadii) 

T Geocarpon minimum (No common name) 

T Orchid, western prairie fringed (Platanthera praeclara)

T Pogonia, small whorled (Isotria medeoloides) 

E Pondberry (Lindera melissifolia) 

T Sneezeweed, Virginia (Helenium virginicum) 

T Orchid, eastern prairie fringed (Platanthera leucophaea)

Nebraska (US-FWS, 2011q) 

Animals – 12 listings 

Status Species 

E Beetle, American burying (Nicrophorus americanus) 

E Crane, whooping except where EXPN (Grus americana) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Shiner, Topeka (Notropis topeka (=tristis)) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Tiger beetle, Salt Creek (Cicindela nevadica lincolniana) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Curlew, Eskimo (Numenius borealis) 

E Ferret, black-footed entire population, except where EXPN (Mustela nigripes) 

Plants – 5 listings 

Status Species 

T Butterfly plant, Colorado (Gaura neomexicana var. coloradensis) 
Status Species 

T Orchid, western prairie fringed (Platanthera praeclara) 

E Penstemon, blowout (Penstemon haydenii) 

T Ladies'-tresses, Ute (Spiranthes diluvialis) 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

New Jersey (US-FWS, 2011r) 

Animals – 19 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Mitchell's satyr (Neonympha mitchellii mitchellii) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

E Tern, roseate northeast U.S. nesting pop. (Sterna dougallii dougallii) 

T Tiger beetle, northeastern beach (Cicindela dorsalis dorsalis) 

T Turtle, bog (=Muhlenberg) northern (Clemmys muhlenbergii) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 7 Listings 

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

T Beaked-rush, Knieskern's (Rhynchospora knieskernii) 

E Chaffseed, American (Schwalbea americana) 

T Joint-vetch, sensitive (Aeschynomene virginica) 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Pink, swamp (Helonias bullata) 

T Pogonia, small whorled (Isotria medeoloides) 

 
New York (US-FWS, 2011s) 

Animals – 23 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

T Snail, Chittenango ovate amber (Succinea chittenangoensis) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

E Tern, roseate northeast U.S. nesting pop. (Sterna dougallii dougallii) 

T Tiger beetle, northeastern beach (Cicindela dorsalis dorsalis) 

T Turtle, bog (=Muhlenberg) northern (Clemmys muhlenbergii) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 11 listings 

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

E Bulrush, Northeastern (Scirpus ancistrochaetus) 

E Chaffseed, American (Schwalbea americana) 

T Fern, American hart's-tongue (Asplenium scolopendrium var. americanum) 

E Gerardia, sandplain (Agalinis acuta) 

T Goldenrod, Houghton's (Solidago houghtonii) 

T Monkshood, northern wild (Aconitum noveboracense) 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Pink, swamp (Helonias bullata) 

T Pogonia, small whorled (Isotria medeoloides) 

T roseroot, Leedy's (Rhodiola integrifolium ssp. leedyi) 

 
North Carolina (US-FWS, 2011t) 

Animals – 40 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bat, Virginia big-eared (Corynorhinus (=Plecotus) townsendii virginianus) 

E Bean, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations (Villosa 

trabalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Saint Francis' satyr (Neonympha mitchellii francisci) 

T Chub, spotfin Entire (Erimonax monachus) 

E Elktoe, Appalachian (Alasmidonta raveneliana) 

E Heelsplitter, Carolina (Lasmigona decorata) 

E Manatee, West Indian (Trichechus manatus) 

E Mussel, oyster Entire Range; Except where listed as Experimental Populations (Epioblasma capsaeformis) 

E Pearlymussel, littlewing (Pegias fabula) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E Riffleshell, tan (Epioblasma florentina walkeri (=E. walkeri)) 

E Sawfish, smalltooth (Pristis pectinata) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Shiner, Cape Fear (Notropis mekistocholas) 

T Silverside, Waccamaw (Menidia extensa) 

T Snail, noonday (Mesodon clarki nantahala) 

E Spider, spruce-fir moss (Microhexura montivaga) 

E Spinymussel, James (Pleurobema collina) 

E Spinymussel, Tar River (Elliptio steinstansana) 

E Squirrel, Carolina northern flying (Glaucomys sabrinus coloratus) 

E Stork, wood AL, FL, GA, SC (Mycteria americana) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

E Tern, roseate northeast U.S. nesting pop. (Sterna dougallii dougallii) 

T Tern, roseate Western Hemisphere except NE U.S. (Sterna dougallii dougallii) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Whale, sperm (Physeter catodon (=macrocephalus)) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Wolf, red except where EXPN (Canis rufus) 

E Woodpecker, red-cockaded (Picoides borealis) 
Plants – 27 Listings 

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

E Arrowhead, bunched (Sagittaria fasciculata) 

E Avens, spreading (Geum radiatum) 

E Bittercress, small-anthered (Cardamine micranthera) 

T Blazingstar, Heller's (Liatris helleri) 

E Bluet, Roan Mountain (Hedyotis purpurea var. montana) 

E Chaffseed, American (Schwalbea americana) 

E Coneflower, smooth (Echinacea laevigata) 

E Dropwort, Canby's (Oxypolis canbyi) 

T Goldenrod, Blue Ridge (Solidago spithamaea) 

E Harperella (Ptilimnium nodosum) 

T Heartleaf, dwarf-flowered (Hexastylis naniflora) 

T Heather, mountain golden (Hudsonia montana) 

E Irisette, white (Sisyrinchium dichotomum) 

T Joint-vetch, sensitive (Aeschynomene virginica) 

E Lichen, rock gnome (Gymnoderma lineare) 

E Loosestrife, rough-leaved (Lysimachia asperulaefolia) 

E Meadowrue, Cooley's (Thalictrum cooleyi) 

T Pink, swamp (Helonias bullata) 

E Pitcher-plant, green (Sarracenia oreophila) 

E Pitcher-plant, mountain sweet (Sarracenia rubra ssp. jonesii)

T Pogonia, small whorled (Isotria medeoloides) 

E Pondberry (Lindera melissifolia) 

E Sedge, golden (Carex lutea) 

T Spiraea, Virginia (Spiraea virginiana) 

E Sumac, Michaux's (Rhus michauxii) 

E Sunflower, Schweinitz's (Helianthus schweinitzii) 

North Dakota (US-FWS, 2011u) 

Animals – 7 listings 

Status Species 

E Crane, whooping except where EXPN (Grus americana) 

E Ferret, black-footed entire population, except where EXPN (Mustela nigripes) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus)

E Beetle, American burying (Nicrophorus americanus) 
Plants – 1 listing 

Status Species 

T Orchid, western prairie fringed (Platanthera praeclara)

Ohio (US-FWS, 2011v) 

Animals – 24 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Catspaw, white (pearlymussel) (Epioblasma obliquata perobliqua) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Fanshell (Cyprogenia stegaria) 

E Madtom, Scioto (Noturus trautmani) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E purple cat's paw (=purple cat's paw pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma obliquata obliquata) 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

T Snake, copperbelly water Indiana north of 40 degrees north latitude, Michigan, Ohio (Nerodia erythrogaster 

neglecta) 

T Snake, Lake Erie water subspecies range clarified (Nerodia sipedon insularum) 

E Dragonfly, Hine's emerald (Somatochlora hineana) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mussel, scaleshell (Leptodea leptodon) 

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Pocketbook, fat (Potamilus capax) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E Ring pink (mussel) (Obovaria retusa) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Butterfly, Mitchell's satyr (Neonympha mitchellii mitchellii) 

Plants – 6 listings 

Status Species 

E Clover, running buffalo (Trifolium stoloniferum) 

T Daisy, lakeside (Hymenoxys herbacea) 

T Monkshood, northern wild (Aconitum noveboracense) 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Spiraea, Virginia (Spiraea virginiana) 

T Pogonia, small whorled (Isotria medeoloides) 
Oklahoma (US-FWS, 2011w) 

Animals – 18 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bat, Ozark big-eared (Corynorhinus (=Plecotus) townsendii ingens) 

E Beetle, American burying (Nicrophorus americanus) 

T Cavefish, Ozark (Amblyopsis rosae) 

E Crane, whooping except where EXPN (Grus americana) 

E Curlew, Eskimo (Numenius borealis) 

T Darter, leopard (Percina pantherina) 

T Madtom, Neosho (Noturus placidus) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mussel, scaleshell (Leptodea leptodon) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Pocketbook, Ouachita rock (Arkansia wheeleri) 

T Shiner, Arkansas River Arkansas R. Basin (Notropis girardi) 

E Tern, least interior pop. (Sterna antillarum) 

E Vireo, black-capped (Vireo atricapilla) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Woodpecker, red-cockaded (Picoides borealis) 

Plants – 2 listings 

Status Species 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Orchid, western prairie fringed (Platanthera praeclara) 

Pennsylvania (US-FWS, 2011x) 

Animals – 19 listings 

Status Species 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Fanshell (Cyprogenia stegaria) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata)

E Pigtoe, rough (Pleurobema plenum) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 
Status Species 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

E Ring pink (mussel) (Obovaria retusa) 

E Squirrel, Delmarva Peninsula fox Entire, except Sussex Co., DE (Sciurus niger cinereus) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

T Tiger beetle, northeastern beach (Cicindela dorsalis dorsalis) 

T Turtle, bog (=Muhlenberg) northern (Clemmys muhlenbergii) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 6 listings 

Status Species 

E Bulrush, Northeastern (Scirpus ancistrochaetus) 

T Pogonia, small whorled (Isotria medeoloides) 

T Spiraea, Virginia (Spiraea virginiana) 

E Coneflower, smooth (Echinacea laevigata) 

T Joint-vetch, sensitive (Aeschynomene virginica) 

T Orchid, eastern prairie fringed (Platanthera leucophaea)

South Carolina (US-FWS, 2011y) 

Animals – 26 listings 

Status Species 

E Heelsplitter, Carolina (Lasmigona decorata) 

E Manatee, West Indian (Trichechus manatus) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

T Salamander, frosted flatwoods (Ambystoma cingulatum) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Stork, wood AL, FL, GA, SC (Mycteria americana) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

E Warbler (=wood), Bachman's (Vermivora bachmanii) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 

E Woodpecker, red-cockaded (Picoides borealis) 

E Bat, Indiana (Myotis sodalis) 

E Beetle, American burying (Nicrophorus americanus) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

T Snake, eastern indigo (Drymarchon corais couperi) 
Status Species 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Sawfish, smalltooth (Pristis pectinata) 

T Tern, roseate Western Hemisphere except NE U.S. (Sterna dougallii dougallii) 

E Warbler, Kirtland's (Dendroica kirtlandii) 

E Wolf, red except where EXPN (Canis rufus) 

Plants – 21 listings 

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

T Amphianthus, little (Amphianthus pusillus) 

E Arrowhead, bunched (Sagittaria fasciculata) 

E Chaffseed, American (Schwalbea americana) 

E Coneflower, smooth (Echinacea laevigata) 

E Dropwort, Canby's (Oxypolis canbyi) 

T Gooseberry, Miccosukee (Ribes echinellum) 

E Harperella (Ptilimnium nodosum) 

T Heartleaf, dwarf-flowered (Hexastylis naniflora) 

E Irisette, white (Sisyrinchium dichotomum) 

E Lichen, rock gnome (Gymnoderma lineare) 

E Loosestrife, rough-leaved (Lysimachia asperulaefolia) 

T Pink, swamp (Helonias bullata) 

E Pitcher-plant, mountain sweet (Sarracenia rubra ssp. jonesii) 

T Pogonia, small whorled (Isotria medeoloides) 

E Pondberry (Lindera melissifolia) 

E Quillwort, black spored (Isoetes melanospora) 

E Sumac, Michaux's (Rhus michauxii) 

E Sunflower, Schweinitz's (Helianthus schweinitzii) 

E Trillium, persistent (Trillium persistens) 

E Trillium, relict (Trillium reliquum) 

South Dakota (US-FWS, 2011z) 

Animals – 11 listings 

Status Species 

E Beetle, American burying (Nicrophorus americanus) 

E Crane, whooping except where EXPN (Grus americana) 

E Ferret, black-footed entire population, except where EXPN (Mustela nigripes) 

E Mussel, scaleshell (Leptodea leptodon) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Shiner, Topeka (Notropis topeka (=tristis)) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 
Status Species 

E Curlew, Eskimo (Numenius borealis) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

Plants – 1 listing 

Status Species 

T Orchid, western prairie fringed (Platanthera praeclara)

Tennessee (US-FWS, 2011aa) 

Animals – 72 listings 

Status Species 

E Acornshell, southern (Epioblasma othcaloogensis) 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bean, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations (Villosa 

trabalis) 

E Bean, purple (Villosa perpurpurea) 

E Beetle, American burying (Nicrophorus americanus) 

E Blossom, green (pearlymussel) (Epioblasma torulosa gubernaculum) 

E Blossom, tubercled (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Epioblasma torulosa torulosa) 

E Blossom, turgid (pearlymussel) Entire Range; Except where listed as Experimental Populations (Epioblasma 

turgidula) 

E Blossom, yellow (pearlymussel) Entire Range; Except where listed as Experimental Populations (Epioblasma 

florentina florentina) 

T Chub, slender (Erimystax cahni) 

T Chub, spotfin Entire (Erimonax monachus) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Clubshell, ovate (Pleurobema perovatum) 

E Clubshell, southern (Pleurobema decisum) 

E Combshell, Cumberlandian Entire Range; Except where listed as Experimental Populations (Epioblasma 

brevidens) 

E Combshell, upland (Epioblasma metastriata) 

E Crayfish, Nashville (Orconectes shoupi) 

T Dace, blackside (Phoxinus cumberlandensis) 

E Darter, amber (Percina antesella) 

E Darter, bluemask (=jewel) (Etheostoma sp.) 

E Darter, boulder (Etheostoma wapiti) 

E Darter, duskytail Entire (Etheostoma percnurum) 

T Darter, goldline (Percina aurolineata) 

T Darter, slackwater (Etheostoma boschungi) 

T Darter, snail (Percina tanasi) 

E Elktoe, Appalachian (Alasmidonta raveneliana) 

E Elktoe, Cumberland (Alasmidonta atropurpurea) 
Status Species 

E Fanshell (Cyprogenia stegaria) 

E Kidneyshell, triangular (Ptychobranchus greenii) 

E Lampmussel, Alabama Entire Range; Except where listed as Experimental Populations (Lampsilis virescens)

E Lilliput, pale (pearlymussel) (Toxolasma cylindrellus) 

E Logperch, Conasauga (Percina jenkinsi) 

E Madtom, pygmy Entire (Noturus stanauli) 

E Madtom, smoky Entire (Noturus baileyi) 

T Madtom, yellowfin except where EXPN (Noturus flavipinnis) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Marstonia, royal (snail) (Pyrgulopsis ogmorhaphe) 

E Moccasinshell, Coosa (Medionidus parvulus) 

E Monkeyface, Appalachian (pearlymussel) (Quadrula sparsa) 

E Monkeyface, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Quadrula intermedia) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, oyster Entire Range; Except where listed as Experimental Populations (Epioblasma capsaeformis) 

E Mussel, scaleshell (Leptodea leptodon) 

E Panther, Florida (Puma (=Felis) concolor coryi) 

E Pearlymussel, birdwing Entire Range; Except where listed as Experimental Populations (Conradilla caelata)

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pearlymussel, dromedary Entire Range; Except where listed as Experimental Populations (Dromus dromas) 

E Pearlymussel, littlewing (Pegias fabula) 

E Pigtoe, Cumberland (Pleurobema gibberum) 

E Pigtoe, finerayed Entire Range; Except where listed as Experimental Populations (Fusconaia cuneolus) 

E Pigtoe, Georgia (Pleurobema hanleyianum) 

E Pigtoe, rough (Pleurobema plenum) 

E Pigtoe, shiny Entire Range; Except where listed as Experimental Populations (Fusconaia cor) 

E Pigtoe, southern (Pleurobema georgianum) 

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus) 

T Pocketbook, finelined (Lampsilis altilis) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E purple cat's paw (=purple cat's paw pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma obliquata obliquata) 

E Rabbitsfoot, rough (Quadrula cylindrica strigillata) 

E Riffleshell, tan (Epioblasma florentina walkeri (=E. walkeri)) 

E Ring pink (mussel) (Obovaria retusa) 

E Riversnail, Anthony's Entire Range; Except where listed as Experimental Populations (Athearnia anthonyi) 

T Shiner, blue (Cyprinella caerulea) 

E Shiner, palezone (Notropis albizonatus) 

T Snail, painted snake coiled forest (Anguispira picta) 

E Spider, spruce-fir moss (Microhexura montivaga) 

E Squirrel, Carolina northern flying (Glaucomys sabrinus coloratus) 

E Sturgeon, pallid (Scaphirhynchus albus) 

E Tern, least interior pop. (Sterna antillarum) 

E Wartyback, white (pearlymussel) (Plethobasus cicatricosus) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 
Plants – 21 listings 

Status Species 

E Aster, Ruth's golden (Pityopsis ruthii) 

E Avens, spreading (Geum radiatum) 

E Bladderpod, Spring Creek (Lesquerella perforata) 

E Bluet, Roan Mountain (Hedyotis purpurea var. montana) 

E Chaffseed, American (Schwalbea americana) 

E Coneflower, Tennessee purple (Echinacea tennesseensis) 

T Fern, American hart's-tongue (Asplenium scolopendrium var. americanum) 

T Goldenrod, Blue Ridge (Solidago spithamaea) 

E Grass, Tennessee yellow-eyed (Xyris tennesseensis) 

E Ground-plum, Guthrie's (=Pyne's) (Astragalus bibullatus) 

E Leather flower, Morefield's (Clematis morefieldii) 

E Lichen, rock gnome (Gymnoderma lineare) 

E Pitcher-plant, green (Sarracenia oreophila) 

T Pogonia, small whorled (Isotria medeoloides) 

T Potato-bean, Price's (Apios priceana) 

E Prairie-clover, leafy (Dalea foliosa) 

E Rock-cress, Braun's (Arabis perstellata) 

T Rosemary, Cumberland (Conradina verticillata) 

E Sandwort, Cumberland (Arenaria cumberlandensis) 

T Skullcap, large-flowered (Scutellaria montana) 

T Spiraea, Virginia (Spiraea virginiana) 

Texas (US-FWS, 2011ab) 

Animals – 64 listings 

Status Species 

E Amphipod, Peck's cave (Stygobromus (=Stygonectes) pecki) 

E Bat, Mexican long-nosed (Leptonycteris nivalis) 

T Bear, Louisiana black (Ursus americanus luteolus) 

E Beetle, American burying (Nicrophorus americanus) 

E Beetle, Coffin Cave mold (Batrisodes texanus) 

E Beetle, Comal Springs dryopid (Stygoparnus comalensis) 

E Beetle, Comal Springs riffle (Heterelmis comalensis) 

E Beetle, Helotes mold (Batrisodes venyivi) 

E Beetle, Kretschmarr Cave mold (Texamaurops reddelli) 

E Beetle, Tooth Cave ground (Rhadine persephone) 

E Crane, whooping except where EXPN (Grus americana) 

E Curlew, Eskimo (Numenius borealis) 

E Darter, fountain (Etheostoma fonticola) 

E Falcon, northern aplomado (Falco femoralis septentrionalis) 

E Flycatcher, southwestern willow (Empidonax traillii extimus) 
Status Species 

E Gambusia, Big Bend (Gambusia gaigei) 

E Gambusia, Clear Creek (Gambusia heterochir) 

E Gambusia, Pecos (Gambusia nobilis) 

E Gambusia, San Marcos (Gambusia georgei) 

E Ground beetle, [unnamed] (Rhadine exilis) 

E Ground beetle, [unnamed] (Rhadine infernalis) 

E Harvestman, Bee Creek Cave (Texella reddelli) 

E Harvestman, Bone Cave (Texella reyesi) 

E Harvestman, Cokendolpher Cave (Texella cokendolpheri) 

E Jaguar (Panthera onca) 

E Jaguarundi, Gulf Coast (Herpailurus (=Felis) yagouaroundi cacomitli) 

E Manatee, West Indian (Trichechus manatus) 

E Margay Mexico southward (Leopardus (=Felis) wiedii) 

E Meshweaver, Braken Bat Cave (Cicurina venii) 

E Meshweaver, Government Canyon Bat Cave (Cicurina vespera) 

E Meshweaver, Madla's Cave (Cicurina madla) 

E Meshweaver, Robber Baron Cave (Cicurina baronia) 

T Minnow, Devils River (Dionda diaboli) 

E Minnow, Rio Grande silvery Entire, except where listed as an experimental population (Hybognathus 

amarus) 

E Ocelot (Leopardus (=Felis) pardalis) 

T Owl, Mexican spotted (Strix occidentalis lucida) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Prairie-chicken, Attwater's greater (Tympanuchus cupido attwateri) 

E Pseudoscorpion, Tooth Cave (Tartarocreagris texana) 

E Pupfish, Comanche Springs (Cyprinodon elegans) 

E Pupfish, Leon Springs (Cyprinodon bovinus) 

E Salamander, Barton Springs (Eurycea sosorum) 

T Salamander, San Marcos (Eurycea nana) 

E Salamander, Texas blind (Typhlomolge rathbuni) 

E Sawfish, smalltooth (Pristis pectinata) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

T Shiner, Arkansas River Arkansas R. Basin (Notropis girardi) 

E Snail, Pecos assiminea (Assiminea pecos) 

T Snake, Concho water (Nerodia paucimaculata) 

E Spider, Government Canyon Bat Cave (Neoleptoneta microps) 

E Spider, Tooth Cave (Leptoneta myopica) 

E Tern, least interior pop. (Sterna antillarum) 

E Toad, Houston (Bufo houstonensis) 

E Vireo, black-capped (Vireo atricapilla) 

E Warbler (=wood), golden-cheeked (Dendroica chrysoparia) 

E Whale, finback (Balaenoptera physalus) 
Status Species 

E Whale, humpback (Megaptera novaeangliae) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Wolf, red except where EXPN (Canis rufus) 

E Woodpecker, red-cockaded (Picoides borealis) 

Plants – 29 listings 

Status Species 

E Ambrosia, south Texas (Ambrosia cheiranthifolia) 

E Ayenia, Texas (Ayenia limitaris) 

E Bladderpod, white (Lesquerella pallida) 

E Bladderpod, Zapata (Lesquerella thamnophila) 

E Cactus, black lace (Echinocereus reichenbachii var. albertii) 

T Cactus, Chisos Mountain hedgehog (Echinocereus chisoensis var. chisoensis) 

T Cactus, Lloyd's Mariposa (Echinomastus mariposensis) 

E Cactus, Nellie cory (Coryphantha minima) 

E Cactus, Sneed pincushion (Coryphantha sneedii var. sneedii) 

E Cactus, star (Astrophytum asterias) 

E Cactus, Tobusch fishhook (Ancistrocactus tobuschii) 

E Cat's-eye, Terlingua Creek (Cryptantha crassipes) 

T Cory cactus, bunched (Coryphantha ramillosa) 

E Dawn-flower, Texas prairie (Hymenoxys texana) 

E Dogweed, ashy (Thymophylla tephroleuca) 

E Frankenia, Johnston's (Frankenia johnstonii) 

E Ladies'-tresses, Navasota (Spiranthes parksii) 

E Manioc, Walker's (Manihot walkerae) 

T Oak, Hinckley (Quercus hinckleyi) 

E Phlox, Texas trailing (Phlox nivalis ssp. texensis) 

E Pitaya, Davis' green (Echinocereus viridiflorus var. davisii) 

E Pondweed, Little Aguja (=Creek) (Potamogeton clystocarpus) 

E Poppy-mallow, Texas (Callirhoe scabriuscula) 

E Rush-pea, slender (Hoffmannseggia tenella) 

E Sand-verbena, large-fruited (Abronia macrocarpa) 

E Snowbells, Texas (Styrax texanus) 

T Sunflower, Pecos (=puzzle, =paradox) (Helianthus paradoxus) 

E Wild-rice, Texas (Zizania texana) 

T Geocarpon minimum (No common name) 

Virginia (US-FWS, 2011ac) 

Animals – 53 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 
Status Species 

E Bat, Virginia big-eared (Corynorhinus (=Plecotus) townsendii virginianus) 

E Bean, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations (Villosa 

trabalis) 

E Bean, purple (Villosa perpurpurea) 

E Blossom, green (pearlymussel) (Epioblasma torulosa gubernaculum) 

T Chub, slender (Erimystax cahni) 

T Chub, spotfin Entire (Erimonax monachus) 

E Combshell, Cumberlandian Entire Range; Except where listed as Experimental Populations (Epioblasma 

brevidens) 

E Darter, duskytail Entire (Etheostoma percnurum) 

E Fanshell (Cyprogenia stegaria) 

E Isopod, Lee County cave (Lirceus usdagalun) 

T Isopod, Madison Cave (Antrolana lira) 

E Logperch, Roanoke (Percina rex) 

T Madtom, yellowfin except where EXPN (Noturus flavipinnis) 

E Monkeyface, Appalachian (pearlymussel) (Quadrula sparsa) 

E Monkeyface, Cumberland (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Quadrula intermedia) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 

E Mussel, oyster Entire Range; Except where listed as Experimental Populations (Epioblasma capsaeformis) 

E Pearlymussel, birdwing Entire Range; Except where listed as Experimental Populations (Conradilla caelata)

E Pearlymussel, cracking Entire Range; Except where listed as Experimental Populations (Hemistena lata) 

E Pearlymussel, dromedary Entire Range; Except where listed as Experimental Populations (Dromus dromas) 

E Pearlymussel, littlewing (Pegias fabula) 

E Pigtoe, finerayed Entire Range; Except where listed as Experimental Populations (Fusconaia cuneolus) 

E Pigtoe, rough (Pleurobema plenum) 

E Pigtoe, shiny Entire Range; Except where listed as Experimental Populations (Fusconaia cor) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Rabbitsfoot, rough (Quadrula cylindrica strigillata) 

E Riffleshell, tan (Epioblasma florentina walkeri (=E. walkeri)) 

E Salamander, Shenandoah (Plethodon shenandoah) 

T Sea turtle, green except where endangered (Chelonia mydas) 

E Sea turtle, hawksbill (Eretmochelys imbricata) 

E Sea turtle, Kemp's ridley (Lepidochelys kempii) 

E Sea turtle, leatherback (Dermochelys coriacea) 

T Sea turtle, loggerhead (Caretta caretta) 

E Snail, Virginia fringed mountain (Polygyriscus virginianus) 

E Spinymussel, James (Pleurobema collina) 

E Squirrel, Delmarva Peninsula fox Entire, except Sussex Co., DE (Sciurus niger cinereus) 

E Sturgeon, shortnose (Acipenser brevirostrum) 

E Tern, roseate northeast U.S. nesting pop. (Sterna dougallii dougallii) 

T Tiger beetle, northeastern beach (Cicindela dorsalis dorsalis) 

E Wedgemussel, dwarf (Alasmidonta heterodon) 

E Whale, finback (Balaenoptera physalus) 

E Whale, humpback (Megaptera novaeangliae) 

E Whale, right (Balaena glacialis (incl. australis)) 
Status Species 

E Woodpecker, red-cockaded (Picoides borealis) 

E Beetle, American burying (Nicrophorus americanus) 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

E Butterfly, Mitchell's satyr (Neonympha mitchellii mitchellii) 

T Dace, blackside (Phoxinus cumberlandensis) 

E Spider, spruce-fir moss (Microhexura montivaga) 

E Squirrel, Carolina northern flying (Glaucomys sabrinus coloratus) 

Plants – 17 listings 

Status Species 

T Amaranth, seabeach (Amaranthus pumilus) 

T Birch, Virginia round-leaf (Betula uber) 

E Bittercress, small-anthered (Cardamine micranthera) 

E Bulrush, Northeastern (Scirpus ancistrochaetus) 

E Chaffseed, American (Schwalbea americana) 

E Coneflower, smooth (Echinacea laevigata) 

T Joint-vetch, sensitive (Aeschynomene virginica) 

E Mallow, Peter's Mountain (Iliamna corei) 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Pink, swamp (Helonias bullata) 

T Pogonia, small whorled (Isotria medeoloides) 

E Rock-cress, shale barren (Arabis serotina) 

T Sneezeweed, Virginia (Helenium virginicum) 

T Spiraea, Virginia (Spiraea virginiana) 

E Sumac, Michaux's (Rhus michauxii) 

E Harperella (Ptilimnium nodosum) 

E Lichen, rock gnome (Gymnoderma lineare) 

West Virginia (US-FWS, 2011ad) 

Animals – 16 listings 

Status Species 

E Bat, gray (Myotis grisescens) 

E Bat, Indiana (Myotis sodalis) 

E Bat, Virginia big-eared (Corynorhinus (=Plecotus) townsendii virginianus) 

E Beetle, American burying (Nicrophorus americanus) 

E Blossom, tubercled (pearlymussel) Entire Range; Except where listed as Experimental Populations 

(Epioblasma torulosa torulosa) 

E Clubshell Entire Range; Except where listed as Experimental Populations (Pleurobema clava) 

E Fanshell (Cyprogenia stegaria) 

T Isopod, Madison Cave (Antrolana lira) 

E Mucket, pink (pearlymussel) (Lampsilis abrupta) 
Status Species 

E Puma (=cougar), eastern (Puma (=Felis) concolor couguar) 

E Riffleshell, northern (Epioblasma torulosa rangiana) 

E Ring pink (mussel) (Obovaria retusa) 

T Salamander, Cheat Mountain (Plethodon nettingi) 

T Snail, flat-spired three-toothed (Triodopsis platysayoides) 

E Spinymussel, James (Pleurobema collina) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 6 listings 

Status Species 

E Bulrush, Northeastern (Scirpus ancistrochaetus)

E Clover, running buffalo (Trifolium stoloniferum)

E Harperella (Ptilimnium nodosum) 

T Pogonia, small whorled (Isotria medeoloides) 

E Rock-cress, shale barren (Arabis serotina) 

T Spiraea, Virginia (Spiraea virginiana) 

Wisconsin (US-FWS, 2011ae) 

Animals – 11 listings 

Status Species 

E Beetle, American burying (Nicrophorus americanus) 

E Butterfly, Karner blue (Lycaeides melissa samuelis) 

E Dragonfly, Hine's emerald (Somatochlora hineana) 

E Higgins eye (pearlymussel) (Lampsilis higginsii) 

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis) 

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula fragosa) 

E Mussel, scaleshell (Leptodea leptodon) 

T Plover, piping except Great Lakes watershed (Charadrius melodus) 

E Plover, piping Great Lakes watershed (Charadrius melodus) 

E Warbler, Kirtland's (Dendroica kirtlandii) 

E Wolf, gray Lower 48 States, except MN and where EXPN. Mexico. (Canis lupus) 

Plants – 7 listings 

Status Species 

T Bush-clover, prairie (Lespedeza leptostachya) 

T Iris, dwarf lake (Iris lacustris) 

T Locoweed, Fassett's (Oxytropis campestris var. chartacea)

T Milkweed, Mead's (Asclepias meadii) 

T Monkshood, northern wild (Aconitum noveboracense) 
Status Species 

T Orchid, eastern prairie fringed (Platanthera leucophaea) 

T Thistle, Pitcher's (Cirsium pitcheri) 

BIBLIOGRAPHY

US-FWS. (2011a). Alabama. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=AL&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011aa). Tennessee. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=TN&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011ab). Texas. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=TX&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011ac). Virginia. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=VA

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011ad). West Virginia. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=WV

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011ae). Wisconsin. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=WI&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011b). Arkansas. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=AR&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011c). Delaware. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=DE&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011d). Florida. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=FL&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011e). Georgia. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=GA

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011f). Illinois. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=IL&s

8fid=112761032792&s8fid=112762573902

US-FWS. (2011g). Indiana. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=IN&

s8fid=112761032792&s8fid=112762573902
US-FWS. (2011h). Iowa. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=IA&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011i). Kansas. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=KS&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011j). Kentucky. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=KY

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011k). Louisiana. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=LA&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011l). Maryland. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=MD

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011m). Michigan. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=MI&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011n). Minnesota. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=MN

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011o). Mississippi. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=MS

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011p). Missouri. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=MO

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011q). Nebraska. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=NE&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011r). New Jersey. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=NJ&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011s). New York. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=NY

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011t). North Carolina. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=NC&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011u). North Dakota. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=ND

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011v). Ohio. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=OH

&s8fid=112761032792&s8fid=112762573902
US-FWS. (2011w). Oklahoma. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=OK

&s8fid=112761032792&s8fid=112762573902

US-FWS. (2011x). Pennsylvania. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=PA&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011y). South Carolina. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=SC&

s8fid=112761032792&s8fid=112762573902

US-FWS. (2011z). South Dakota. Retrieved March 15, 2011, from 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrenceIndividual.jsp?state=SD&

s8fid=112761032792&s8fid=112762573902
APPENDIX D 

ADDENDUM 1 of PETITION FOR NONREGULATED STATUS, 

MARKET IMPACT OF MON 87705 HIGH OLEIC SOYBEAN OIL 

MONSANTO PETITION NUMBER : 09-SY-201U 

Petition for the Determination of Nonregulated Status for 

Improved Fatty Acid Profile 

MON 87705 Soybean 

ADDENDENDUM I 

Market Impact of MON 87705 

High Oleic Soybean Oil 

Submitted April 7, 2011 

OECD Unique Identifier: MON-87705-6 

Monsanto Petition Number: 09-SY-201U 

 
1. Introduction 

Overall total use of oils derived from plant sources (vegetable oil) for food and industrial 

applications exceeded 14 million tons in North America in 2009. Due to its abundance, reliable 

supply and price, soybean oil is one of the most highly used of the vegetable oils (Attachment I, 

Table 3.1, pg 62). In 2009, soybean oil accounted for approximately 8.2 million tons of food and 

1.2 million ton of industrial vegetable oil uses (See Attachment I, Part 1b, pg 17-18). Soybean 

oil use in foods peaked at roughly 9.3 million tons in the 2006/2007 timeframe just before the 

U.S. Food and Drug Administration required food labels to report trans-fat content in 2006. 

(http://www.fda.gov/Food/LabelingNutrition/ConsumerInformation). The demand for soybean 

oil for frying and baking applications has declined in recent years due to the desire to lower 

unhealthy trans-fat in the diet and changes in food labeling policy. 

High oleic soybean oil produced using MON 87705 has a fatty acid profile that has reduced 

saturated fats, and higher monounsaturated fat. These properties, particularly the reduction in 

polyunsaturated fats (18:2), result in increased oil oxidative stability greatly improving oil 

performance in frying and baking applications. The decrease in saturated fat (16:0, 18:0) further 

improves the nutritional profile of the oil for use in food preparation. MON 87705 will be bred 

into Vistive low-linolenic soybean further improving the oil profile by lowering the level of 

linolenic acid and eliminating the need to hydrogenate the oil. 

Monsanto has conducted a market and trade assessment to evaluate the potential impacts on 

commodity soybean oil and other vegetable oils due to the introduction of high oleic soybean oil. 

The assessment considered that other vegetable oils including high oleic vegetable oils are 

currently on the market and are routinely handled by oil processors and food formulators. The 

system responsible for production, harvest, processing and handling of soybean and other 

vegetable oils includes critical control points as well as economic incentives for identity 

preserved soybean oils and other vegetable oils. Typically, the processor will assess the fatty 

acid profile of the oil sold to a food manufacturer prior to sale. If the fatty acid profile were 

different from commodity soybean oil, the oil could be blended (a common industry practice) to 

reach the appropriate fatty acid content based on specific food applications. On the basis of this 

assessment it is concluded that the introduction of high oleic soybean oil will have little if any 

potential for negative market impacts. In the event that comingling did occur, the economic 

impact of comingling to a food manufacturer would be minimal and remedied through blending. 

A summary of the intended uses for high oleic soybean oil, current processes for handling 

vegetable oils and potential impacts to commodity soybean oil as well as other vegetable oils is 

provided in this document. 

2. Intended Uses of High Oleic Soybean Oil 

 

 Vistive is a registered trademark of Monsanto Technology LLC 
Commodity soybean oil does not have the optimum fatty acid profile to satisfy many of the 

needs of the food industry7

. The fatty acid profile for soybean oil does not provide optimal 

oxidative stability compared to other vegetable oils unless modified via hydrogenation or 

through blending with other vegetable oils. Hydrogenation creates unhealthy trans-fat making 

soybean oil less desirable for use in some applications. In addition, due to low oxidative 

stability, commodity soybean oil is not highly stable for cooking and frying when used in these 

applications, causing several operational challenges such as more frequent exchange of vegetable 

oil stocks and/or replacement of oil and polymerization, leading to frequent costly equipment 

cleaning. For these reasons, in recent years, soybean oil has lost share to other vegetable oils in 

food applications (Wilson, 2004; Attachment I, Part 2, pg 38). 

Given recent food labeling policy changes and modifications to dietary guidelines, the food 

industry is seeking vegetable oils that not only have enhanced functionality but minimize levels 

of trans- and saturated fat; the balance of fatty acids (high oleic, low saturated fat, low linolenic) 

is often difficult to achieve with current vegetable oil options. Soybean oil competes with other 

oils such as palm, canola, sunflower, peanut and corn. These oils are generally blended to satisfy 

food companies seeking to address functional or nutrition related needs. High oleic soybean oil 

can provide a complementary option either as a straight replacement of blended oils or as a 

blending alternative to end users. While blending achieves the food company’s objective, it is 

costly due to increased handling, average oil price and required technical support (Attachment I, 

Part 4, pg 75). 

Through conventional plant breeding, MON 87705 will be bred with Vistive low-linolenic 

soybean. Vistive low-linolenic soybean was developed through conventional plant breeding to 

produce lower levels of linolenic acid allowing food companies to avoid hydrogenation of 

soybean oil helping to eliminate unhealthy trans fatty acids from the diet. The low linolenic 

soybean has a mutation in the Fad3-1c and Fad3-1b genes that result in reduced levels of 

linolenic acid. The Vistive low-linolenic soybean oil is currently commercially sold in the 

United States. The soybean oil from MON 87705 in the Vistive low-linolenic soybean 

background has the following specification: palmitic acid (< 4.0%); stearic acid (< 4.0%); oleic 

acid (55 - 85%); linoleic acid (8 – 30%); and linolenic acid (< 4.0%). The modification of the 

fatty acid profile provides an equal or better alternative to vegetable oil options available today 

and offers the opportunity to reduce the practice of blending which has become the solution for 

fry applications to avoid trans-fats. The observed fatty acid profile of MON 87705 soybean and 

MON 87705 in a Vistive low-linolenic soybean genetic background are presented in Table 1. 

 

7

http://qualisoy.com 
Figure 1. Fatty acid synthesis in MON 87705 in a Vistive low-linolenic genetic background 

Table 1. Fatty acid composition (% weight of soybeans) of MON 87705 soybeans and 

MON 87705 in a Vistive low-linolenic soybean background 

Year C16:0 C18:0 C18:1 C18:2 C18:3 

MON 87705

20071 2.36 3.31 76.47 10.10 6.69 

MON 87705 in a Vistive low-linolenic soybean background 

20072 2.60 3.05 77.27 13.77 2.63 

20082

 2.47 2.97 75.30 15.60 2.96 

20093

 2.31 3.29 71.21 19.03 3.20 

20104

 2.20 3.43 76.83 13.73 2.47 

1

Samples were obtained from field trials conducted in Chile in the 2007/2008 growing season. See USDA Petition 

Number 09-201-01p. 2

Grown in Jerseyville, IL. 

3

Samples were obtained from 8 U.S. locations (2 sites each in the states of IA, IL, IN, and OH). Value is mean of 

the 8 individual site values. 

4

Samples were obtained from 3 U.S. locations (2 sites in IL and one site in OH). Value is mean of the 3 individual 

site values. 

The safety of MON 87705 soybeans in a Vistive low-linolenic soybean genetic background is 

based on the long-standing history of safe consumption of the levels and types of fatty acids 

contained in commercial vegetable oils with a fatty acid profile similar to MON 87705 soybeans 
in Vistive low-linolenic background. Monsanto has completed a safety assessment8

 of high oleic 

soybean oil and high oleic soybean oil is generally recognized, among qualified experts, as 

having been adequately shown to be safe under the conditions of its intended use. MON 87705 

soybean in a Vistive low-linolenic soybean genetic background does not contain any new fatty 

acids that are not presently found in conventional food oils and the fatty acid profile of this oil is 

similar to many other commercial oils currently available including canola, olive oil, high oleic 

safflower oil, and high oleic sunflower oil (See Table 2). The oil from MON 87705 soybeans in 

a Vistive low linolenic soybean genetic background provides options for food formulation that is 

virtually trans fat-free, and, unlike palm oil, is low in saturated fat. 

 Table 2. Fatty acid composition (% weight) of MON 87705 in Vistive background in 

comparison to soybean oil and other high oleic vegetable oils 1

Oil Saturated 

fats trans fats Oleic acid Linoleic 

acid 

Linolenic 

acid 

Other fatty 

acids 

Soybean oil, all purpose 15.2 0.7 22.6 50.1 6.5 4.9 

PH Soybean 2 24.7 34.1 31.4 4.5 0.2 5.1 

MON 87705 in Vistive 

background 3 6.8 0.22 71.7 16.9 2.9 1.5 

HOSO (305423) 4 14.27 0 70.6 5.5 7.2 3.4 

Olive oil 13.8 0 71.3 9.8 0.8 4.3 

HOLLCO 5 3 0 84 7 2 4 

High oleic canola 6.5 0.8 70 14.3 2.6 5.8 

Canola 7.6 1.6 60.6 17.7 6.4 6.1 

High oleic Sunflower 9.7 0 82.6 3.6 0.2 3.9 

1 The fatty acid profiles of PH soybean oil (partially hydrogenated soybean oil), olive oil, canola oil, high oleic canola oil, and 

high oleic sunflower oil were obtained from the USDA nutrient database (USDA 2008, National Nutrient Database for 

Standard Reference. U.S. Department of Agriculture (USDA), Agricultural Research Service (ARS), Nutrient Data 

Laboratory; Beltsville, Maryland. Available from: http://www.nal.usda.gov/fnic/foodcomp/search/). 2 PH Soybean: partially hydrogenated soybean oil. 3 MON 87705 in Vistive background fatty acid composition is based on the pooled analysis of 8 oil lots. 4 HOSO (305423): high oleic soybean oil from Pioneer/DuPont, defined in Delaney (2008). 5 HOLLCO: High oleic low linolenic canola oil, values from Möllers (2004). 

 

8

See FDA GRAS assessment at: 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPac

kaging/ucm061846.htm#Q1 
Vegetable oils are used in twelve broadly grouped end use sectors: snacks, salad oils (use in 

mayonnaise, salad dressings and other food products), margarine, bottled oils (home use), par 

fry, ingredient, confectionary, baked goods, industrial fry, restaurant, institutional, and food 

service (Attachment I, Part 2, pg 37). High oleic soybean oil is targeted for ten of the twelve end 

use sectors with bottled and salad oils not considered a commercial target for high oleic soybean 

oil because commodity soybean oil currently serving these sectors does not require 

hydrogenation and products currently have acceptable shelf lives. 

Industrial uses such as bio lubricants and biodiesel are also possible end uses of high oleic 

soybean oil. High oleic soybean oil is a renewable resource and is an attractive option as the 

price of crude petroleum continues to increase. The increased levels of oleic acid in high oleic 

soybean oil enhance the stability and lubricity of the oil making it a superior bio lubricant 

compared to petroleum based oils and a good feedstock for biodiesel (Graef et. al, 2009). 

Food and industrial end use sectors are currently supplied by commodity soybean oil as well as 

domestic and imported blends of other vegetable oils (e.g. palm oil). Thus, high oleic soybean 

oil would potentially replace commodity soybean oil and oil blends currently used for these 

applications. 

3. Market Potential of High Oleic Soybean Oil 

In order to assess the market potential for high oleic soybean oil, Monsanto commissioned a 

study that included an in-depth analysis of the vegetable oil market in North America that was 

performed by LMC International (Attachment I). The study was conducted to assess the 

potential demand for vegetable oil with the fatty acid properties of high oleic soybean oil. 

Factors considered included current uses of vegetable oils and their physical properties, health 

attributes of the oil, availability and price. The market potential estimate assumed that high oleic 

soybean oil was used in the target food sectors described above as a direct replacement for 

hydrogenated soybean oil and other vegetable oils (such as canola, corn, palm and sunflower) 

used in food applications (Attachment I, part 5; pg 88). The demand for high oleic soybean oil is 

price sensitive relative to other vegetable oils. To estimate of the maximum high oleic soybean 

the lowest price premium ($50/metric ton) was used. At the lowest price premium, high oleic 

soybean would achieve a demand for the oil estimated at 3.5 million metric tons. On the basis of 

this analysis, approximately 16 million acres of high oleic soybean would satisfy the demand if 

high oleic soybean oil were to replace current uses of hydrogenated soybean and other high oleic 

vegetable oils in food and industrial applications (Attachment I, Part 5, pg 90)9

. Additional acres 

would likely be planted to supply high oleic soybean oil for industrial uses. Based on 

assumptions regarding product adoption and acceptance by the industry, Monsanto estimates it 

would take at least a decade for high oleic soybeans to achieve this acreage and at peak 

penetration, this level would represent approximately 23% of total planted soybean acres10. 

 

9

 One bushel of soybean = 60 lbs and contains 10.7 lb oil (Wilson, 2004); average yield of soybean = 43.7 bushels 

per acre in 2010 (USDA NASS: http://www.nass.usda.gov) 

10 Assumes 70 million acres of soybean are planted. 
Subsequently, there would continue to be adequate supply of both commodity and high oleic 

soybeans to serve the vegetable oil market needs. 

4. Production and Handling of Vegetable Oils 

Crop production and distribution systems as well as oil processors and food manufactures have 

demonstrated the ability to handle multiple vegetable oils derived from numerous crop species. A 

summary of the current practices including critical control points for production of soybean oil 

and specialty soybean oil (e.g. Vistive low linolenic) is provided below. There are numerous 

vegetable oils on the market today including: palm, coconut, palm kernel, cottonseed, soybean, 

groundnut, rapeseed and sunflower (Attachment I, Part 2, pg 38). Other minor use oils include 

olive, corn, high oleic canola, high oleic sunflower oil and low linoleic soybean oil (Vistive). 

The processing industry (e.g. Cargill, Bunge, ADM, etc.) and end users of such oils are highly 

adept at handling these vegetable oils in their normal course of business. As a result, processors 

have developed methods to segregate multiple vegetable oil feedstocks as they are financially 

motivated to prevent mishaps with their customers. High oleic soybean, for planting and 

subsequent processing, would be introduced to the market place as an option for processors to 

supply food companies and those who seek a U.S. based vegetable oil option. 

Once key global market approvals are obtained, oil from MON 87705 will be available as an 

option for use by food processors and will be produced in an identity preserved (IDP) fashion 

similar to the system that has been successfully implemented for production of Vistive low 

linolenic soybean and other specialty vegetable oils. IDP practices are implementd for value 

added specialty soybean to capture the enhanced value of the product and ensure that the enduser or processor receives the soybean with the desired identity, fatty acid profile and quality. 

Vistive low-linolenic soybean was made available to growers in 2005 and has been grown on 

over 3.0 million acres since its initial launch. 

A summary of the quality control systems associated with seed production, crop production, 

processing and end uses of high oleic soybean oil is presented in Figure 2. 

 
Figure 2. Production and use checkpoints for high oleic soybean 

Seed Production and Processing. Monsanto is a leader in crop biotechnology having 

successfully introduced numerous biotech crops to the marketplace. Monsanto has developed 

and implemented seed quality practices to assure that soybean seed meets the standards 

established for purity of a trait. These standards apply to all soybean seed sold by Monsanto and 

are based upon measures that seed producers put in place to assure the genetic purity of 

improved planting seed. This system is used to assure that farmers receive seed of known 

quality with a minimum level of off types. 

The first step in the process for production of high oleic soybean is the production, processing 

and delivery of high quality seed to the grower. The entire seed production process at the 

majority of the seed companies and tollers operate using International Organization for 

Standardization (ISO) certification or standards and; therefore, include internal and external 

audits (ISO, 2009). ISO standards ensure desirable characteristics of seeds and services, such as 

quality, safety, reliability, and efficiency. The ISO standards represent an international 

consensus on good management practices with the aim of ensuring that the organization can 

consistently deliver excellent product or services. The standards not only must meet the 

customer’s requirements and applicable seed regulatory requirements, but must aim to enhance 

customer satisfaction and achieve continual improvement of its performance in pursuit of these 

objectives (ISO, 2009). 

Commercially certified soybean seed must meet state and federal seed standards and labeling 

requirements. The Association of Official Seed Certifying Agencies (AOSCA) standards for 

certified soybean seed are as follows: 98% pure seed (minimum), 2% inert matter (maximum), 

0.05% weed seed (maximum, not to exceed 10 per 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) (AOSCA, 2009). Seed that meets or exceeds these standards are provided in 

appropriately labeled seed bags to growers 

Production of Soybean Grain Containing High Oleic Soybean Oil. Specialty soybean (e.g. 

Vistive low linolenic) is currently produced under contracts issued by processors or elevators. It 

is expected that high oleic soybean will be produced using this system as well. 

There are three major factors needing to be satisfied before a farmer will produce a specialty 

soybean containing a modified soybean oil, like high oleic. These factors have become evident 

in Monsanto’s experience in the crop production of Vistive low linolenic soybeans. 

1. Yield of the soybean must be comparable to commodity soybeans routinely planted 

2. The option to market, price & deliver the grain must be comparable to commodity grain 

3. The premium paid to the farmer to offset the cost to identity preserve the high oleic 

containing grain must provide incremental income opportunity above the production of 

commodity grain. The income opportunity cannot be realized by the farmer unless the grain 

is delivered to the processor within specifications or in its identity preserved state. 

Therefore, the motivation is a financial incentive for the farmer to avoid comingling with 

commodity grain, keeping all the grain identity preserved within this closed loop system of 

seed – farmer - processor. Many farmers willingly choose to plant all their acreage to this 

specialty soybean because it eliminates any risk of contamination from inadvertent errors that 

may occur during the harvest. If a farmer chooses to produce the specialty grain for the 

processor, the farmer will arrange to store the grain on farm or at their local elevator, if the 

elevator is participating in the specialty program with the processor. 

The steps involved in securing grain production are: 

1. Monsanto will sell and distribute high oleic soybean seed to the farmer after the farmer has 

signed and agreed to the conditions of Monsanto’s Technology and Stewardship Agreement. 

The agreement will mandate that the farmer sell any soybean produced into an identity 

preservation channel (See Figure 2). 

2. Processors will be responsible to contract with elevators and growers the acreage needed to 

fulfill the expected demand for high oleic soybean. 

3. After harvest, the farmer will deliver the grain produced to the location specified in his 

contract, either a participating elevator or processor. If to the elevator, the elevator will keep 

the grain segregated from commodity grain and pay the farmer his premium, provided it 

passes the analytical testing. The elevator will deliver the grain to the processor as delivery 

windows and crush schedules have been established. Upon delivery of grain by the farmer, 

samples will be analyzed from every truckload by Near Infrared Transmittance (NIT) 

developed by Monsanto. This will confirm the grain contains high oleic soybean oil as 

required by the production contract. Upon confirmation of grain that meets specification of 

high oleic soybean grain, the processor or elevator will approve the premium payment to the 

farmer. 

In the event that high oleic soybean do not meet the minimum specifications established for 

oil quality, the soybean would be isolated from other high oleic or commodity soybean and 
blended with an appropriate quantity of high oleic soybean to meet the specifications 

required for a food application. Monsanto has been conducting field trials with high oleic 

soybean since 2005 and has considerable experience with trait performance in various 

genetic backgrounds and under various climatic conditions. Trait performance has been 

consistent over several years of breeding (See Table 10). All soybean varieties that 

Monsanto will introduce must meet specifications for agronomic performance and oil quality. 

While it is not envisioned that any of the high oleic soybean varieties will underperform, 

blending with other high oleic soybean is the most likely remedy. 

Grain Elevator. Grain elevators play an important role in specialty programs with their long 

term storage of the grain. Since processing facilities crush soybeans throughout the calendar 

year, soybeans used to supply these crush plants need to be stored year round. Farmers typically 

prefer to empty their storage prior to planting of the new crop and prior to temperature warm up 

in the spring. The warm spring and summer weather present challenges as condensation can 

build up in the bins creating moisture related issues and grain eating insects become more active. 

Farmers prefer to avoid these high management grain conditions. Commercial elevators have 

expert grain managers on staff to monitor grain quality and keep grain in condition in all weather 

situations presented throughout the year. 

Commercial grain elevators are also better equipped to ship grain to processors during times of 

severe weather or when farmers cannot get to their bins when roads are impassable. 

Processors will therefore enter into supply contracts with commercial grain elevators for these 

reasons. Contracts will be “acre” based, established to fill bin capacity that has been agreed 

upon by both parties. Grain elevators will then contract with farmers directly, providing harvest 

storage terms to the farmer with premiums to be paid that have been agreed upon with the 

processor. The elevator pays the farmer the specialty grain premium upon successful analytical 

testing by NIT performed at the elevator location. NIT testing equipment will be provided by 

Monsanto to participating elevators identical to the equipment provided to processors. 

In order for the elevator to be reimbursed for the premiums paid out to farmers that have 

delivered to them, the elevator must in turn preserve the identity of the grain as it is delivered to 

the processor. 

Every load delivered to the processor by the elevator will be analyzed using NIT technology. 

Processors will approve the premium payment to the elevator after analysis of the grain confirms 

high oleic soybean oil. 

Processing Oil and Meal. Specialty high oleic soybean grain will be introduced into the 

processing plant as it is running commodity soybean grain. Upon the transition from commodity 

soybeans in the plant, the processor will ensure that the equipment is lined out and operating 

within normal and acceptable limits and parameters using commodity soybean. High oleic 

soybeans will then be moved through the plant continuously until all specialty grain located at 

the plant is gone. After all of the specialty high oleic soybeans have moved through the seed 

prep building, the bins and conveyors feeding the seed prep building will be filled with 
commodity soybeans to keep the plant running continuously. Commodity soybeans will then be 

processed as normal. 

Upon the transition from commodity soybeans to the high oleic soybeans, a sample of crude oil 

is required to confirm the presence of the appropriate fatty acid composition (FAC) unique to 

high oleic oil. Until the fatty acid composition of the crude oil exiting the extractor is of the 

appropriate composition, as determined by the plant manager, off spec crude oil will be sent to a 

tank that will be designated for flush oil. This will contain all oil before and after the collection 

of “on-spec” high oleic oil. High oleic crude oil that is collected with the appropriate FAC will 

be designated for further refining, bleaching, and deodorization. The processor’s lab will be 

used to aid in identifying the appropriate time to start collecting crude high oleic oil exiting the 

extractor that will undergo further refining. The lab will use gas chromatography equipment to 

analyze the crude oil to determine when on spec high oleic oil can be collected from the 

extractor. A tank approved for high oleic oil will be assigned by a processor employee. After all 

high oleic grain has been processed, the seed extraction area will be flushed with commodity 

soybeans, and regular commodity oil will be produced. During the flush, crude oil exiting the 

extractor will be sampled and analyzed to confirm the equipment has been flushed to an 

acceptable level, yielding commodity soybean oil. 

Processes are established by the processor to ensure the transfer of high oleic oil to the crude oil 

tank farm to minimize loss and maximize quality. The lab at the processor will utilize 

appropriate analytical methods to determine when the high oleic oil is of proper quality to send 

to the main crude tank(s) that will supply oil for further refining. Commodity soybean flush oil 

prior to and after the crush of the high oleic oil will be collected in tanks designated as flush, and 

will be blended with commodity soybean oil to bring the flush oil into a specification range 

necessary to be sold as commodity soybean oil. 

Food Company. Oil will be supplied to the food company by oil processors and suppliers. The 

processor or supplier will test the oil and assure that it meets specific customer requirements 

including quality factors (e.g. peroxide value, oxidative stability index, color, flavor) and oil 

composition (customized blends, specified fatty acid composition). Foodservice distributors 

typically obtain the oil from the oil processors and deliver it to each foodservice outlet 

(individual stores, caterers, cafeterias, etc). From the time the oil is packaged, until it is utilized 

at the specific customer’s facility, there is proper identification of the oil through labeling and 

manufacturing codes allowing for sufficient product traceability if needed. Individual facilities 

will utilize proprietary inventory and ordering systems that are in place to insure that the 

appropriate oil is ordered, delivered and utilized. 

High oleic soybean oil will be used by the food industry in several ways. One specific type of 

food company customer will be foodservice operators including quick service restaurants, casual 

dining and full service restaurants who will use high oleic soybean oil as a fry medium and in 

meal preparation. Food companies will also use high oleic soybean oil as a food ingredient in a 

range of food products including as spray oil on crackers and snacks, or as a component of oil 

blends used in shortenings and other foods. Each individual food company has in place systems 

for ingredient (oil) ordering, receipt, storage, access and lot identification at specific 

manufacturing locations, as well as finished product (the food which incorporates high oleic 

soybean oil) batch identification, manufacturing facility, storage, shipment to distribution 
centers, customer order picking, customer order shipment and receipt. Appropriate procedures 

are currently in place to insure traceability from receipt of the ingredient through distribution to a 

specific retailer’s facility. Food companies routinely conduct mock recalls including use of the 

media should the need arise. Food manufacturing facilities also comply with federal and state 

requirements for good manufacturing practices and product traceability. Supply chain 

consultants can be employed to confirm appropriate systems have been established that meet 

ingredient and product traceability requirements. 

5. Stewardship of High Oleic Soybean 

Monsanto is committed to product stewardship and to implementing BIO’s "Excellence through 

Stewardship" program and Product Launch Stewardship Policy11. Monsanto considered Annex 2 

“Special Use traits in Commodity Crops” 12 to develop launch plans for high oleic soybean oil 

including: (1) identifying relevant stakeholders for the trait and crop and engaging them in 

dialogue regarding use of high oleic soybean oil and potential impacts to vegetable oil markets, 

(2) conducting a market and trade assessment, including securing regulatory approvals in key 

export countries prior to full commercial launch, (3) developing a risk mitigation plan, and (4) 

undertaking appropriate outreach, necessary to educate stakeholders and implement the 

management plan for high oleic soybean oil. These actions protect against adverse impacts to 

trade of soybean due to the introduction of a new biotechnology improved soybean. 

Stakeholder Dialogue 

Monsanto is committed to dialogue with key industry stakeholder groups and has held several 

meetings with the National Oil Processors Association (NOPA) as well as other key industry 

associations such as the North American Export Grain Association (NAEGA), National Grain 

and Feed Association (NGFA), North American Milling Association (NAMA), American Bakers 

Association (ABA), and Grocery Manufacturers Association (GMA). Soybean grower 

organizations: American Soybean Association (ASA), United States Soybean Board (USB), and 

many state soybean associations. In addition QUALISOY, a collaborative program sponsored by 

the USB that serves as an independent, third part resource for information on trait-enhanced 

soybean oils, has been kept informed on the plans for this product, along with leaders in dietary 

and nutrition fields. 

Market and Trade Assessment 

Monsanto has conducted a market and trade assessment to determine the impact of the 

introduction of high oleic soybean oil. Soybean is a globally traded commodity with the U.S. 

being the top global producer (Soyatech, 2010). Biotechnology-derived crops and their use as 

food and feed are subject to regulation in many countries. In order to support continued trade in 

soybean, Monsanto is pursuing regulatory approval for MON 87705 in all key soybean import 

countries with a functioning regulatory system to support the flow of international trade. 

 

11 http://www.monsanto.com/ourcommitments/Pages/product-stewardship.aspx 

12 http://www.bio.org/letters/Product_Launch_Stewarship_12_10_09.pdf; 
International regulatory authorities are evaluating the biotech component as well as the modified 

oil fraction. It is expected that uses of high oleic oil soybean will be similar on a global basis. 

There would be no impact to human heath or to the use of any of the other processed fractions 

produced from soybean due to comingling of high oleic soybean with commodity soybean. 

Monsanto has completed a GRAS assessment of the high oleic soybean oil (MON 87705 in a 

Vistive background)13 and has completed the biotechnology consultation on MON 87705 with 

the U.S. FDA14. The GRAS assessment has been evaluated by FDA and the agency had no 

further questions. The biotechnology consultation considered the food and feed safety impacts 

due to the genetic modification process, RNAi suppression of two endogenous enzymes resulting 

in modification to fatty acid metabolism, as well as exposure to the CP4 EPSPS protein. The 

GRAS assessment considered the nutritional impact of total replacement of commodity soybean 

oil with high oleic soybean oil. High oleic soybean oil is similar to other high oleic vegetable 

oils that are commonly consumed producing no harmful effects to humans. Hence, Monsanto as 

well as a panel of qualified scientific experts have concluded that high oleic soybean oil is 

generally recognized as safe. 

Information provided to USDA showed that the impact due to the suppression of the two 

endogenous enzymes is restricted to seed. With the exception of the intended changes in fatty 

acid composition and presence of the CP4 EPSPS protein, the soybean meal and other processed 

fractions used for animal feed and human food applications are compositionally equivalent to 

commodity processed soybean fractions15. Monsanto provided information to USDA in the 

petition demonstrating that the composition of the meal was compositionally equivalent to meal 

derived from conventional soybean and safe and wholesome for food or feed applications. 

Monsanto has assessed the impact of the introduction high oleic soybean oil on commodity and 

other vegetable oils. In response to stakeholder dialogue, Monsanto was specifically requested 

by NOPA to address the impact of comingling of commodity soybean oil with high oleic 

soybean oil to bottled oils (100% commodity soybean oil) and severe heat processing (e.g. 

impact to frying applications and sensory properties of prepared foods). This assessment has 

been shared with key stakeholders such as NOPA, NAEGA, ASA, Qualisoy, USB and GMA. 

Hypothetical impacts were assessed using the following scenario: (1) high oleic soybean grain 

or oil went unnoticed and was comingled ( e.g. harvest mistake, inadvertent mixing of grain 

during transport, mistaken delivery of grain, etc...), (2) the comingled soybean were delivered to 

an oil processor and mixed with commodity grain or soybean oil, (3) the oil or grain was not 

analyzed for oil composition by anyone in the food supply chain, and (4) the comingled oil was 

used in the food or feed supply chain. This scenario is highly unlikely given existing critical 

 

13http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandP

ackaging/ucm061846.htm#Q1 

14Biotechnology notice: BNF 121: http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing; 

GRAS notice: GRN 306 - http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing&page=2 

15 USDA Petition Number 09-201-01p, Section VII.C. 
control points embedded in the production handling and processing system and because high 

oleic soybean oil is expected to be produced in a contractual identity preserved system in order to 

preserve its premium value. Processors will originate the supply of high oleic soybeans and as 

they have extensive experience managing, segregating, testing, formulating and blending other 

sources of high oleic vegetable oils such as high oleic canola and high oleic sunflower oil. 

Bottled vegetable oil is not an intended use for high oleic soybean oil. However, bottle oil was 

used to assess potential impacts at the request of NOPA. It represents a readily measurable 

impact that could occur if high oleic soybean were comingled with 100% commodity soybean. 

Mixing high oleic soybean with commodity soybean will impact to the levels of fatty acids in 

commodity soybean. This effect is measurable and can potentially translate into downstream 

effects to food labeling, oil quality, and functionality. Even though such comingling is 

improbable, potential impacts were assessed at several different comingling levels ranging from 

4% and up to 30% using four different parameters: (1) food ingredient labeling, (2) nutritional 

facts panel labeling (3) functionality of the oil, and (4) sensory evaluation. 

Food Ingredient Labeling Codex Specification. Effects were assessed on the ability to meet 

USP Food Chemical Codex (USP FCC) soybean oil labeling specification. In Table 3 the 

impact of varying amounts of high oleic soybean oil comingled with commodity soybean oil 

on the ability to meet specifications for major fatty acids is evaluated. The USP FCC is a 

compendium of internationally recognized standards for the purity and identity of food 

ingredients and is used as a set of agreed standards between buyers and manufacturers of 

food ingredients16. Based on this analysis the most sensitive fatty acid is 18:2 linoleic acid. 

If high oleic soybean were co-mingled with commodity soybean oil at levels above 14%, the 

linoleic acid (C 18:2) content of the resulting oil following processing would fall below the 

USP FCC specification for commodity soybean oil. At levels above 15% oleic (C 18:1), 

linoleic acid would be out of the specifications for soybean oil. 

To put this into perspective, 15% comingling could occur due to a farmer mistakenly 

harvesting approximately three acres of high oleic soybean (assuming yield = 43 

bushels/acre) and comingling it with commodity soybean in a grain truck hauling the 

standard load limit with a capacity of 900 bushels. If the grain were delivered to a grain 

elevator or directly to a processor, it would be mixed with other commodity soybean grain 

thereby diluting the high oleic soybean considerably with commodity soybean. The capacity 

of grain elevators or bin storage tanks is highly variable; however, bin capacities up to and 

exceeding 1⁄2 million bushels are quite common. Hence, it would take roughly 83 fully 

loaded trucks containing 100% high oleic soybean or multiple mistakes during harvest of 

high oleic soybean to achieve a 15% level of comingling. 

Nutrition Facts Panel Labeling. Figure 3 and 4 demonstrate the amount of high oleic 

soybean oil that would be required to be comingled with commodity soybean oil in order to 

impact the Nutrition Facts Panel for major fatty acid categories. Based on this analysis, 

 

16 http://www.usp.org/fcc/ 
monounsaturated fat is the most sensitive fatty acid category and comingling up to 5% high 

oleic soybean oil could be tolerated before the Nutrition Facts Panel label for 

monounsaturated fatty acids were impacted on retail bottled vegetable oil. Up to 15% high 

oleic soybean could be comingled with commodity soybean oil before effects to 

polyunsaturated fatty acid labeling would be impacted. 

The threshold for effects is lower than USP FCC labeling situation discussed above. In this 

case it would take a mistake during harvest of one acre of high oleic soybean comingled with 

900 bushels of commodity soybean in a 900 bushel grain truck or 28 fully loaded trucks 

containing 100% high oleic soybean would need to be delivered to a 1⁄2 million bushel grain 

elevator containing commodity soybean to trigger an effect to the nutritional facts panel 

labeling. 

The impact due to both of the comingling scenario discussed above would be minimal. As 

discussed previously, there would be no impacts to human health and the changes in fatty 

acids would benefit consumers from a nutritional perspective. Mandatory labeling is 

required for saturated fats, in this case comingling levels of up to 28% could be tolerated 

without impacting the level of saturated fats reported on the label. At 28%, the level of 

saturated fat would be lower, enhancing the nutritional profile of the product (Figure 4). 

Oil Functionality; Severe Heat Processing. High oleic soybean oil has an improved stability 

profile compared to commodity soybean oil. An assessment of the impact of comingling of 

high oleic soybean oil with commodity soybean grain and oil was conducted. Information in 

Figure 5 demonstrates that comingling of high oleic soybean oil with commodity soybean oil 

increases the OSI stability index for commodity soybean oil. This outcome is expected since 

soybean oil oxidative stability is drastically influenced by the proportion of monounsaturates 

to polyunsaturates, and high oleic soybean oils are estimated to have improved oxidative 

stability compared to conventional soybean oil (Frankel, 2005). 

Food Sensory Assessment. A sensory assessment of high oleic soybean oil was performed to 

evaluate consumer acceptability of high oleic soybean oil. Figure 6 demonstrates the sensory 

results for high oleic soybean oil in the most challenging environment high temperature food 

frying. In this experiment, commodity soybean oil and blends (5% to 15%) of commodity 

and high oleic soybean oil were used to prepare French fries. Food testers were asked to 

evaluate the quality of the fries using the Sensory Quality System described by King et al 

(2003). The outcome from the sensory evaluation showed that high oleic soybean oil 

comingled with commodity soybean oil blends were essentially the same as commodity 

soybean oil over the six-day period during which the experiment was conducted. Thus, 

comingling of high oleic soybean oil with commodity soybean oil would have no impact to 

the sensory profile of commodity soybean oil should inadvertent comingling occur (Figure 

6). 

The comingling scenarios and impacts above are presented as the most conservative scenarios. 

Oilseed processors and users of vegetable oils are accustomed to the presence of numerous 

vegetable oils of differing fatty acid makeup that are available concurrently for blending and use 

in various food applications. The comingling levels described here where an impact could occur 

in functionality or labeling would happen only in instances where common control points were 
ignored. Such levels of comingling are highly unlikely to occur due to economic incentives to 

growers, legal contracts, stewardship SOP’s (seed quality to end user), and demonstrated 

competency in managing inadvertent comingling with other vegetable oils that have a fatty acid 

profile similar to high oleic soybean oil. In addition, fatty acid analytical methods are widely 

available and used currently by oil processors and food manufacturers. 

Industry Outreach 

Monsanto has held conversations with the soybean and food industry key stakeholders 

mentioned above regarding the oil composition, stewardship plan and performance of MON 

87705. Additionally, Monsanto has consulted with NOPA and industry members of NOPA’s 

biotechnology committee as well as the ASA and USB regarding the fatty acid composition of 

high oleic soybean oil and potential changes to commodity soybean oil due to comingling. 

NOPA and members of their biotechnology committee were provided information related to the 

fatty acid composition of high oleic soybean oil derived from MON 87705 in the Vistive lowlinolenic genetic background as well as oil properties and mixing effects information described 

previously. NOPA and biotechnology committee members agree that potential impacts related 

to the unintended mixing of commodity soybean oil and high oleic soybean oil could be 

remedied through blending, a common industry practice. Given the control points in the system 

and potential market impact of high oleic soybean oil, a risk mitigation plan (as described in 

Annex 2 of BIO’s Product Launch Stewardship Policy) for high oleic soybean is not warranted. 

NOPA and the committee members continue to provide input on various aspects of the intended 

commercialization. 

6 Summary 

High oleic soybean offers an opportunity for soybean growers to recapture markets for vegetable 

oil previously occupied by soybean oil and create added value for U.S. soybean producers. 

Given the abundance of vegetable oils on the market and demonstrated ability of the system to 

adapt to consumer preferences incorporating new oils into existing food manufacturing 

processes, the market impact of high oleic soybean is expected to be minimal and easily 

managed. Monsanto has conducted and is implementing a product stewardship plan that is based 

upon consideration of BIO’s Launch Stewardship guidance and upon experience with previous 

successful product introductions completed by Monsanto. Monsanto continues to engage 

stakeholders and educate them on the benefits of high oleic soybean and proper stewardship 

practices. 
Table 4. Impact of comingling of high oleic soybean oil on Food Codex specifications of commodity soybea

1FCC – Food Chemical Codex specification for named vegetable oils 2HO – Oil profile represents high oleic MON 87705 soybean bred into a low linolenic soybean background. 

Legend. The impact of mixing high oleic soybean oil on the fatty acid profile of commodity soybean oil is depic

The impact to the fatty acid profile was assessed at various percentages of high oleic soybean oil mixed with co

The “break point” reflects the percentage of high oleic soybean oil at which the fatty acid levels in soybean oil 

the USP FCC specification range for soybean oil. 
Figure 3. Impact of comingling high oleic soybean oil with bottled commodity soybeal oil on nutritional fa

and polu unsaturated fatty acids. 

Legend. The impact of mixing high oleic soybean oil on nutritional facts labeling for bottled soybean oil is 

above. The impact to nutritional facts panel labeling was assessed at various percentages of high oleic socommodity soybean oil. The blue arrows indicate the levels of high oleic soybean oil that would impac

labeling.
Figure 4. Impact of comingling high oleic soybean oil with bottled commodity soybeal 

oil on nutritional facts labeling to saturated fatty acids. 

Legend. The impact of mixing high oleic soybean oil on nutritional facts labeling for bottled 

soybean oil is depicted in the figure above. The impact to nutritional facts panel labeling was 

assessed at various percentages of high oleic soybean oil mixed with commodity soybean oil. 

The blue arrows indicate the levels of high oleic soybean oil that would impact the nutritional 

facts labeling for mandatory fatty acid reporting (saturated fats).
Figure 5. Oxidative stability index of high oleic soybean blended with commodity soybean 

oil. 

Legend. The impact of comingling of high oleic soybean oil was assessed on the oxidative 

stability index of the blended oil. The OSI stability index is an indicator of soybean oil stability. 

All oils and fats have a resistance to oxidation, which depends on the degree of saturation, 

antioxidant and prooxidant concentration, and prior abuse. Oxidation is slow until this resistance 

is overcome, at which point oxidation accelerates and becomes more rapid. The length of time 

prior to the acceleration of oxidation is referred to as the ‘induction period,’ and the point of 

maximum rate change is referred to as the Oxidative Stability Index or Oil Stability Index (OSI), 

and is reported in hours (Frankel, 2005).

0.00

2.00

4.00

6.00

8.00

10.00

12.00

14.00

16.00

18.00

20.00

0 10 20 30 40 50 60 70 80 90 100

OSI

@ 110oC

% High Oleic in Commercial Soy Oil
Figure 6. Sensory assessment of high oleic soybean oil compared to other vegetable oils. 

Legend. A sensory assessment of the quality of French fries prepared in blends of high oil/commodity soybe

over a period of six days. A modification of the procedure described by King et al (2002) was used for the ev

qualities of the oil blends tested were essentially the same over the six-day period. Scale: 5 = no difference, 4 = 3 = slight difference, 2 = different, 1 = very different. 
References 

AOSCA 2009. Seed Certification Handbook. Association of Official Seed Certifying Agencies. 

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Delaney, B., Appenzeller, L. M., Munley, S. M., Hoban, D., Sykes, G. P., Malley, L. and 

Sanders, C. (2008) Subchronic feeding study of high oleic acid soybeans (Event DP-3Ø5423-1) 

in Sprague-Dawley rats, Food and Chemical Toxicology, 46, 3808-3817. 

Frankel, E.N., 2005. Pages 21, 201-205 in Lipid Oxidation. The Oily Press, Bridgewater, 

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Graef, G., LaVallee, B.J., Tenopir, P., Tat, M., Schweiger, B., Kinney, A.J., Van Gerpen, J.H. 

and T.E. Clemente. 2009. A high-oleic-acid and low-palmitic-acid soybean: agronomic 

performance and evaluation as a feedstock for biodiesel. Plant Biotechnology Journal, 7:411-

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ISO. 2009. Selection and Use of the ISO 9000 Family of Standards. International Organization 

for Standardization. http://www.iso.org [Accessed March, 2010]. 

King. S., Gillette, M., Titman, D., Adams, J., and M. Ridgely. 2002. The sensory quality 

system: a global quality control system. Food Quality and Preferences, 13: 385-395. 

Möllers, C. (2004) Potential and future prospects for rapeseed oil. In: Gunstone, F. D. (ed.) 

Rapeseed and Canola Oil. Production, Processing, Properties and Uses. CRC Press LLC, Boca 

Raton, FL, pp. 186-217. 

Soyatech. 2010. Statistics. Soyatech, Manitoba, Canada. 

Wilson, 2004. Seed composition. P. 621-629. In Boerma, H.R. and Specht, J.E. (eds.) 

Sopybeans: Improvement, production and uses. ASA-CSSA-SSSA, Madison, Wisconsin. 1144 

pp. 
DRAFT MONSANTO 87705 SOYBEAN 

ATTACHMENT I 

THE MARKET POTENTIAL FOR A HIGH OLEIC SOYBEAN OIL 

CONFIDENTIAL BUSINESS INFORMATION 

CBI Deleted 

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