Syngenta and Bayer Petition 12-215-01p for

Determination of Non-regulated Status of 

Herbicide Tolerant Event SYHT0H2 

Soybean (Glycine max)

OECD Unique Identifier: 

SYN-ØØØH2-5

Environmental Assessment

March 2014

Table of Contents

ACRONYMS AND ABBREVIATIONS................................................................................ vii

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

1.1 Background.................................................................................................................1

1.2 Purpose of Product......................................................................................................1

1.3 Coordinated Framework Review and Regulatory Review .........................................2

1.3.1 USDA-APHIS.................................................................................................3

1.3.2 Environmental Protection Agency..................................................................3

1.3.3 Food and Drug Administration .......................................................................4

1.4 Purpose and Need for APHIS Action .........................................................................5

1.5 Public Involvement.....................................................................................................5

1.6 Public Comment Period for Petition 12-15-01p .........................................................7

1.7 Issues Considered .......................................................................................................7

2 AFFECTED ENVIRONMENT........................................................................................9

2.1 Soybean Biology.........................................................................................................9

2.2 Agricultural Production of Soybean .........................................................................11

2.2.1 Current and Projected Acreage and Range of Soybean Production .............11

2.2.2 Agronomic Practices.....................................................................................13

2.2.3 Commercial Soybean Production and Uses..................................................30

2.3 Physical Environment...............................................................................................36

2.3.1 Soil................................................................................................................36

2.3.2 Water Quality................................................................................................39

2.3.3 Air Quality ....................................................................................................40

2.3.4 Climate..........................................................................................................40

2.4 Biological Resources ................................................................................................41

2.4.1 Animal Communities....................................................................................41

2.4.2 Plant Communities........................................................................................42

2.4.3 Soil Microorganisms.....................................................................................46

2.4.4 Biodiversity...................................................................................................47

2.4.5 Gene Movement in the Natural Environment...............................................49

2.5 Public Health.............................................................................................................50

2.5.1 Human Health ...............................................................................................50

2.5.2 Worker Safety ...............................................................................................52

2.5.3 Animal (Livestock) Health ...........................................................................53

2.6 Socioeconomic Factors.............................................................................................54

2.6.1 Domestic Trade Environment.......................................................................54

2.6.2 Foreign Trade Environment..........................................................................56

2.6.3 Social and Economic Environment...............................................................58

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3 ALTERNATIVES............................................................................................................61

3.1 No Action: Continuation as a Regulated Article ......................................................61

3.2 Preferred Alternative: Determination that SYHT0H2 Soybean is No Longer a 

Regulated Article ......................................................................................................61

3.2.1 Alternatives Considered, Not Included in Detailed Analysis.......................62

3.3 Comparison of Alternatives......................................................................................64

4 ENVIRONMENTAL CONSEQUENCES.....................................................................68

4.1.1 Scope of the Environmental Analysis...........................................................69

4.1.2 Assumptions..................................................................................................70

4.2 Soybean Production ..................................................................................................71

4.2.1 Acreage and Areas of Soybean Production ..................................................71

4.2.2 Agronomic Practices.....................................................................................73

4.2.3 Commercial Soybean Production and Uses..................................................82

4.3 Physical Environment...............................................................................................85

4.3.1 Soil................................................................................................................85

4.3.2 Water Quality and Use..................................................................................87

4.3.3 Air Quality ....................................................................................................89

4.3.4 Climate..........................................................................................................90

4.4 Natural Biological Communities (Non-Target Organisms)......................................91

4.4.1 Animals.........................................................................................................91

4.4.2 Plants.............................................................................................................92

4.4.3 Soil Microorganisms.....................................................................................94

4.4.4 Biodiversity...................................................................................................95

4.4.5 Gene Movement in the Natural Environment...............................................98

4.5 Public Health.............................................................................................................99

4.5.1 Human Health ...............................................................................................99

4.5.2 Worker Safety .............................................................................................102

4.5.3 Animal (Livestock) Health .........................................................................103

4.6 Socioeconomic Factors...........................................................................................104

4.6.1 Domestic Trade Environment.....................................................................104

4.6.2 Foreign Trade Environment........................................................................106

4.6.3 Social and Economic Environment.............................................................107

5 CUMULATIVE EFFECTS...........................................................................................109

5.1 Introduction.............................................................................................................109

5.2 Agronomic Practices...............................................................................................110

5.3 Water Quality and Use............................................................................................117

5.4 Soil..........................................................................................................................117

5.5 Air Quality ..............................................................................................................118

5.6 Plants.......................................................................................................................118

5.7 Soil Microorganisms...............................................................................................121

5.8 Biodiversity.............................................................................................................122

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5.9 Domestic Trade Environment.................................................................................122

6 THREATENED AND ENDANGERED SPECIES.....................................................123

6.1 Potential Effects of SYHT0H2 Soybean on Threatened or Endangered Species...125

6.1.1 Threatened and Endangered Plant Species and Critical Habitat.................125

6.1.2 Threatened and Endangered Animal Species .............................................126

6.2 Conclusion ..............................................................................................................129

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS ....................................................130

7.1 Executive Orders with Domestic Implications.......................................................130

7.1.1 Executive Order 12898: Environmental Justice .........................................130

7.1.2 Executive Order 13045: Protection of Children .........................................131

7.1.3 Executive Order 13112: Invasive Species ..................................................131

7.1.4 Executive Order 13186: Migratory Birds...................................................132

7.2 Executive Orders with International Implications..................................................132

7.3 Other Federal Laws.................................................................................................133

7.3.1 Clean Water Act..........................................................................................134

7.3.2 Clean Air Act ..............................................................................................134

7.3.3 National Historic Preservation Act .............................................................134

7.3.4 Federal Laws Regarding Unique Characteristics of Geographic Areas .....135

8 REFERENCES...............................................................................................................138

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APPENDICES

A: Mesotrione, Isoxaflutole and Glufosinate: Changes in Application Rates for MGI 

Soybean 

B: Mesotrione Description, Uses, and Potential Impacts

C: Sample Management Plans for SYHT0H2 Soybean 

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LIST OF TABLES

Table No. Description Page

2-1 Transgenic Soybean Cultivars with Herbicide Tolerance Traits that are No 

Longer Subject to the Regulatory Requirements of 7 CFR Part 340 or the 

Plant Pest Provisions of the Plant Protection Act of 2000 .......................11

2-2 Soybean Acreage by State, 2011 and 2012................................................13

2-3 Fertilizer Primary Nutrient Applications to Soybeans in 2006..................18

2-4 Insecticide Applications to Soybeans in 2006 ...........................................20

2-5 Percent of US Soybean Acres Treated With Herbicides; 

1995, 2001, and 2006.................................................................................25

2-6 Total Applications of Herbicides to Soybeans, 2006.................................27

2-7 Common Troublesome Weeds in Treated Soybean Fields; 

2006-2008 ..................................................................................................28

2-8 US Certified Soybean Acreage by State, 2011 ..........................................34

2-9 World Soybean Production, 2011..............................................................56

2-10 World Soybean Exports in 2011/12...........................................................57

2-11 Top 10 US Soybean Export Markets in 2011/2012 

Compared to Previous Years .....................................................................57

2-12 US Export Markets for Soybean and Soybean Products (2011)................58

3-1 Summary of Environmental Consequences and 

Regulatory Compliance .............................................................................64

4-1 Examples of Crop Rotation Plant-Back Intervals......................................76

4-2 Maximum Herbicide Application Rates for Herbicide 

Tolerant Soybean .......................................................................................80

4-3 EIQ Ecological and Overall Field Use Rating of 

Selected Herbicides....................................................................................97

5-1 Corn and Soybean Acres with Glufosinate, Glyphosate, Isoxaflutole or 

Mesotrione Treated as a Percentage of Acres Planted.............................112

5-2 Frequency of Crops as a Rotation Crop with Soybean Crops Registered for 

use with Mesotrione and Stages for Which They are Sensitive..............113

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5-3 Frequency of Crops as a Rotation Crop with Soybean Crops Registered for 

use with Pyrasulfatrole and Stages for Which They are Sensitive ..........113

5-4 Crops Not Registered for HPPD Inhibitors but with Greater than 14% 

Deployment as a Rotation Crop to Soybean (by Percentage of Crop 

Compared to Total Soybean Acres..........................................................114

5-5 Crops Planted Following Soybean with Total Acreage, Percentage of Crop 

Compared to the National Total Crop Planting (In 2008) and the 

Percentage of the Crop Compared to the Total Soybean Acreage...........115

6-1 GE Proteins in SYHT0H2 Soybean.........................................................125

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LIST OF FIGURES

Figure No. Description Page

2-1 Soybeans Planted Acres in 2010 by County for Selected States...............14

2-2 Irrigated Soybeans for Beans; Harvested Acres in 2007 ...........................18

2-3 Percent of US Soybean Acres Treated with the 10 Most Used 

Herbicides; 1995, 2001, and 2006 .............................................................27

2-4 Glyphosate-Resistant Weeds in US Soybean Fields..................................46

2-5 Return per Acre of Soybeans, 1948-2011..................................................56

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ACRONYMS AND ABBREVIATIONS

μg/g Micrograms per gram

A Acre

ACHP Advisory Council on Historic Properties

ai Active ingredient

AIA Advanced Informed Agreement

AMS Agricultural Marketing Service (also USDA-AMS)

AOSCA Association of Official Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service (also USDA-APHIS)

ARMS Agricultural Resource Management Survey

ARS Agricultural Research Services (also USDA-ARS)

ATTRA Appropriate Technology Transfer for Rural Areas

BRS Biotechnology Regulatory Service

C Centigrade

CAA Clean Air Act (also, Clean Air Act Amendments)

CBD Convention on Biological Diversity

CEQ Council on Environmental Quality

CFR Code of Federal Regulations

CH4 Methane

CO Carbon monoxide

CO2 Carbon dioxide

CODEX Codex Alimentarius Commission

CRP Conservation Reserve Program

CWA Clean Water Act (formally, Federal Water Pollution Control Act)

DKN Diketonitrile

DNA Deoxyribonucleic acid

EA Environmental Assessment

EFSA European Food Safety Agency

EIQ Environmental Impact Quotient

EIS Environmental Impact Statement

EO Executive Order

EPA Environmental Protection Agency (also USEPA)

ERS Economic Research Service (also USDA-ERS)

ESA Endangered Species Act

EPSP 5-enolpyruvylshikimate 3-phosphate

ESPS Early soybean production system

EU European Union

FAO Food and Agriculture Organization of the United Nations

FARRP Food Allergy Research and Resource Program

FATUS Foreign Agricultural Trade of the United States

FAS Foreign Agricultural Service (also USDA-FAS)

FDA Food and Drug Administration (also USDHHS-FDA)

FFDCA Federal Food, Drug, and Cosmetic Act

FFP Food, feed, or processing

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FIFRA-FESTF Federal Insecticide, Fungicide, and Rodenticide Act - Endangered Species Task Force

fl oz Fluid ounces

FONSI Finding of No Significant Impact

FQPA Food Quality Protection Act

FR Federal Register

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ACRONYMS AND ABBREVIATIONS (CONTINUED)

FWS Fish and Wildlife Service (also USFWS)

GHG Greenhouse gases

IMS Information Management System

IDP Identity Preservation

IPCC Intergovernmental Panel on Climate Change

HPPD p-Hydroxyphenylpyruvate dioxygenase

lb Pound

LMO Living modified organisms

LOC Level(s) of Concern

Mg/kg bw Milligrams per kilogram of body weight

MG Maturity group

N2O Nitrous oxide

NAPPO North American Plant Protection Organization

NASS National Agricultural Statistics Service (also USDA-NASS)

NEPA National Environmental Policy Act

NHPA National Historic Preservation Act

NMFS National Marine Fisheries Service

NOAEL No observable adverse effect level

NOP National Organic Program

NPS Nonpoint source

NRC National Research Council

NRCA Natural Resources Conservation Service (also USDA-NRCS)

OECD Organization for Economic Cooperation and Development

OTA Organic Trade Association

PAT Phosphinothricin acetyltransferase

PIPs Plant-incorporated protectants

PM Particulate matter

PPA Plant Protection Act

PPRA Plant Pest Risk Assessment

PRA Pest Risk Analysis

pts pints

SOX Sulfur oxides

TSCA Toxic Substances Control Act

US United States

USACE United States Army Corps of Engineers

USC United States Code

USDA United States Department of Agriculture

USDHHS United States Department of Health and Human Services

USEPA United States Environmental Protection Agency (also EPA)

USFWS United States Fish and Wildlife Service (also FWS)

WHO World Health Organization

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1 PURPOSE AND NEED

1.1 Background

Syngenta Seeds, Inc. and Bayer CropScience AG, who collectively are the Petitioners (referred 

hereafter as Syngenta-Bayer), submitted petition number 12-215-01p to the United States 

Department of Agriculture (USDA) Animal and Plant Health Service (APHIS) on July 31, 2012 

seeking approval of the petition for nonregulated status for SYHT0H2 soybean (hereafter 

referred to as SYHT0H2 soybean), the genetically engineered (GE) mesotrione- isoxaflutole- and 

glufosinate- herbicide resistant1 soybean (Glycine max) event SYHT0H2. The Petition was 

revised in response to APHIS’ request for additional information and resubmitted on September 

17, 2012 (Syngenta, 2012d). Field trials of SYHT0H2 soybean have been conducted in multiple

States within U.S. soybean growing regions and in Puerto Rico. Data resulting from these field 

trials are described in the Syngenta petition (Syngenta and Bayer, 2012b) and analyzed for plant 

pest risk in the USDA-APHIS Plant Pest Risk Assessment (PPRA) (USDA-APHIS, 2014b). 

In the event of approval of the petition for nonregulated status, the nonregulated status would 

include SYHT0H2 soybean, any progeny derived from crosses between SYHT0H2 soybean and 

conventional soybean, and crosses of SYHT0H2 soybean with other biotechnology-derived 

soybean that are no longer subject to the regulatory requirements of 7 CFR (Code of Federal 

Regulations) Part 340 or the plant pest provisions of the Plant Protection Act of 2000 (PPA).

1.2 Purpose of Product

The Petitioners have co-developed SYHT0H2 soybean, a new cultivar that has been genetically 

modified to tolerate herbicides that inhibit p-hydroxyphenylpyruvate dioxygenase (HPPD)2 and 

glutamine synthetase. Most soybeans currently grown in the United States are glyphosatetolerant transgenic varieties. SYHT0H2 soybean is a new cultivar that is tolerant of three 

herbicides: mesotrione, isoxaflutole, and glufosinate-ammonium (hereafter, glufosinate). 

SYHT0H2 soybean will offer growers much-needed flexibility to use herbicides with two 

1 Resistance to herbicides is defined by HRAC (Herbicide Resistance Action Committee) as the inherited 

ability of a plant population to survive and reproduce following repeated exposure to a dose of 

herbicide normally lethal to the wild type HRAC, Guideline to the Management of Herbicide 

Resistance, 2013, Herbicide Resistance Action Committee, Available: 

http://www.hracglobal.com/Publications/ManagementofHerbicideResistance.aspx, January 22 2013.. 

Resistance may be induced by genetic engineering or selection of variants produced by tissue culture 

or mutagenesis HRAC, Guideline to the Management of Herbicide Resistance.. This is to be 

distinguished from tolerant, which is defined by HRAC as the inherent ability of a plant to survive and 

reproduce after herbicide treatment. This implies that there was no selection or genetic manipulation 

to make the plant tolerant; it is naturally tolerant HRAC, Guideline to the Management of Herbicide 

Resistance..

2 Common HPPD inhibitor herbicides include mesotrione, isoxaflutole, pyrasulfatole, tembotrione, 

topramezone

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alternative modes of action in their weed management programs and will help minimize or delay 

the evolution of herbicide resistance in weed populations. 

SYHT0H2 soybean contains the transgene avhppd-03 encoding an HPPD enzyme that is more 

than 99.7 percent identical in amino acid sequence to the native HPPD in common oat (Avena 

sativa). In comparison with the native soybean HPPD, the HPPD isozyme from oat has lower 

binding affinity for HPPD-inhibiting herbicides, such as mesotrione and isoxaflutole, and confers 

tolerance to herbicide application rates that would otherwise injure soybean. SYHT0H2 soybean 

also contains the transgene pat derived from Streptomyces viridochromogenes, a ubiquitous soil 

microbe. The gene pat encodes phosphinothricin acetyltransferase (PAT), an enzyme that 

inactivates glufosinate herbicide, an inhibitor of glutamine synthetase. Expression of pat confers 

a glufosinate-tolerance phenotype.

The extensive use of glyphosate-based weed-control programs in corn, cotton, and soybean over 

the past 15 years has resulted in selection for glyphosate-resistant weeds and a shift in weed 

populations to species that are inherently more resistant to glyphosate, thus making weed control 

with glyphosate more difficult (Owen, 2008). Twenty-four glyphosate-resistant weed species 

have been identified globally, 14 of which are found in the US (Heap, 2013a). Cultivation of 

SYHT0H2 soybean (also known as MGI soybean) will provide growers with an opportunity to 

use a glutamine synthetase-inhibitor herbicide (glufosinate) and two HPPD-inhibitor herbicides 

(mesotrione and isoxaflutole) for control of problematic weeds in soybean production systems.

Mesotrione and isoxaflutole are systemic, translocated herbicides with soil residual activity that 

are used for pre-emergence and post-emergence control of predominantly dicot weed species in a 

number of crops, including corn, which has a natural tolerance of these herbicides. Glufosinate is 

a contact herbicide that is applied to crops post-emergence and has no soil residual activity. 

Glufosinate controls a broad spectrum of monocot and dicot weed species. Glufosinate and 

mesotrione/isoxaflutole have distinct herbicidal modes of action, both of which differ from that 

of glyphosate. Using herbicide mixtures and alternating herbicides with different modes of action 

are cornerstones of an integrated weed management program. Both Syngenta and Bayer plan to 

provide stewardship programs for the products as part of comprehensive integrated weed 

management programs which will be offered to growers through training and education 

opportunities for use with SYHT0H2 (MGI) soybean seed.

1.3 Coordinated Framework Review and Regulatory Review

Since 1986, the U.S. government has regulated genetically engineered (GE) organisms pursuant to 

Federal regulations published in the Federal Register (51 FR 23302, 1986) entitled The 

Coordinated Framework for the Regulation of Biotechnology (henceforth referred to here as the 

Coordinated Framework). 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 

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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-APHIS, the U.S. Environmental Protection 

Agency (EPA), and the U.S. Food and Drug Administration (FDA). A summary of each agency’s 

role follows:

1.3.1 USDA-APHIS

USDA-APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority 

granted by the PPA, as amended3 regulates the introduction (i.e., 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 PPA or to the regulatory requirements of 7 CFR 

part 340, when USDA-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 7 CFR 340 

when USDA-APHIS has reason to believe that the GE organism may be a plant pest or USDAAPHIS does not have information to determine if the GE organism is unlikely to pose a plant pest 

risk. 

A person may petition the agency for a determination 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 

PPA or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information 

related to plant pest risk that the agency can 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 

PPA when USDA-APHIS determines that it is unlikely to pose a plant pest risk.

1.3.2 Environmental Protection Agency

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. The 

EPA regulates plant incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA)4 and certain biological control organisms under the Toxic Substances 

Control Act (TSCA)5. Before planting a crop containing a PIP, a company must seek an 

experimental use permit from EPA. Commercial production of crops containing PIPs for purposes 

of seed increases and sale requires a FIFRA Section 3 registration with EPA. 

3 United States Code [USC.] title 7, sections 7701 through 7772

4 7 U.S.C. 136 et seq

5 15 U.S.C. 53 et seq

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Under FIFRA, EPA regulates the use of pesticides, and requires registration of all pesticide 

products for all specific uses prior to distribution for sale. EPA examines: the ingredients of the 

pesticide; the particular site or crop on which it is to be used; the amount, frequency, and timing of 

its use; storage and disposal practices. Prior to registration for a new use for a new or previously 

registered pesticide, EPA must determine through testing that the pesticide does not cause 

unreasonable adverse effects on humans, the environment, and non-target species when used in 

accordance with label instructions. EPA must also approve the language used on the pesticide label 

in accordance with 40 CFR part 158. Once registered, a pesticide may only be legally used in 

accordance with directions and restrictions on its label. The overall intent of the label is to provide 

clear directions for effective product performance, while minimizing risks to human health and the 

environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling EPA to 

implement periodic registration review of pesticides to ensure they are meeting current scientific 

and regulatory standards of safety and continue to have no unreasonable adverse effects (USEPA, 

2011). 

EPA also sets tolerances (maximum residue levels) or establishes an exemption from the 

requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA)6. A 

tolerance is the amount of pesticide residue that can remain on or in food for human consumption 

or animal feed. Before establishing a pesticide tolerance, EPA is required to reach a safety 

determination based on a finding of reasonable certainty of no harm under the FFDCA, as 

amended by the FQPA. FDA enforces the pesticide tolerances set by EPA.

1.3.3 Food and Drug Administration

FDA regulates GE organisms under the authority of the FFDCA7 . The FDA published its policy 

statement concerning regulation of products derived from new plant varieties, including those 

derived from genetic engineering, on May 29, 1992 (57 FR 22984, 1992). Under this policy, FDA 

implements a voluntary consultation process to ensure that human food and animal feed safety 

issues or other regulatory issues, such as labeling, are resolved before commercial distribution of 

bioengineered food. This voluntary consultation process provides a way for developers to receive 

assistance from FDA in complying with their obligations under Federal food safety laws prior to 

marketing.

More recently (June 2006), FDA published recommendations in “Guidance for Industry: 

Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced 

by New Plant Varieties Intended for Food Use” (US-FDA, 2006). This establishes voluntary food 

safety evaluations for new non-pesticidal proteins produced by new plant varieties intended to be 

used as food, including bioengineered plants. Early food safety evaluations help make sure that 

potential food safety issues related to a new protein in a new plant variety are addressed early in 

development. These evaluations are not intended as a replacement for a biotechnology 

consultation with FDA, but the information may be used later in the biotechnology consultation.

6 21 USC 301 et seq.

7 21 USC. 301 et seq.

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1.4 Purpose and Need for APHIS Action

As noted in the previous section, any party can petition USDA-APHIS to seek a determination of 

nonregulated status for a GE organism that is regulated under 7 CFR 340. As required by 7 CFR 

340.6, USDA-APHIS must respond to petitioners that request a determination of the regulated 

status of GE organisms, including GE plants such as SYHT0H2 Soybean. When a petition for 

nonregulated status is submitted, USDA-APHIS must determine if the GE organism is unlikely to 

pose a plant pest risk. 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 PPA when 

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

USDA-APHIS must respond to the petition from Syngenta requesting a determination of 

nonregulated status for SYHT0H2 Soybean. USDA-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) National 

Environmental Policy Act of 1969 (NEPA) regulations and the USDA and USDA-APHIS NEPA 

implementing regulations and procedures (40 CFR Parts 1500-1508, 7 CFR Part 1b, and 7 CFR 

Part 372). This EA has been prepared in order to specifically evaluate the effects on the quality of 

the human environment8 that may result from a determination of nonregulated status for BASF 

SYHT0H2. 

1.5 Public Involvement

USDA-APHIS routinely seeks public comment on EAs prepared in response to petitions seeking a 

determination of nonregulated status of a regulated GE organism. USDA-APHIS does this through 

a notice9 published in the Federal Register. On March 6, 2012, USDA-APHIS published a notice 

in the Federal Register advising the public that APHIS is implementing changes to the way it 

solicits public comment when considering petitions for determinations of nonregulated status for 

GE organisms to allow for early public involvement in the process. As identified in this notice, 

USDA-APHIS will publish two separate notices in the Federal Register for petitions for which 

USDA-APHIS prepares an EA. The first notice will announce the availability of the petition, and 

the second notice will announce the availability of USDA-APHIS’ decision making documents. As 

part of the new process, with each of the two notices published in the Federal Register, there will 

be an opportunity for public involvement:

First Opportunity for Public Comment 

Once USDA-APHIS deems a petition complete, the petition will be made available for public 

comment for 60 days, providing the public an opportunity to raise issues regarding the petition 

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

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

9 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-

5364.pdf

– 5 –
itself and give input that will be considered by the Agency as it develops its EA and PPRA. 

USDA-APHIS will publish a notice in the Federal Register to inform the public that USDAAPHIS will accept written comments regarding a petition for a determination of nonregulated 

status for a period of 60 days from the date of the notice. This availability of the petition for 

public comment will be announced in a Federal Register notice.

Second Opportunity for Public Comment

Assuming an EA is sufficient, the EA and PPRA are developed and a notice of their availability is 

published in a second Federal Register notice. This second notice follows one of two approaches 

for public participation based on whether or not USDA-APHIS decides the petition for a 

determination of nonregulated status is for a GE organism that raises substantive new issues:

Approach 1: GE organisms that do not raise substantive new issues.

This approach for public participation is used when APHIS decides, based on the review of the 

petition and our evaluation and analysis of comments received from the public during the 60-day 

comment period on the petition, that the petition involves a GE organism that does not raise new 

biological, cultural, or ecological issues because of the nature of the modification or APHIS' 

familiarity with the recipient organism. After developing its EA, finding of no significant impact 

(FONSI), and PPRA, USDA-APHIS publishes a notice in the Federal Register announcing its 

preliminary regulatory determination and the availability of the EA, FONSI, and PPRA for a 30-

day public review period.

If USDA-APHIS determines that no substantive information has been received that would warrant 

USDA-APHIS altering its preliminary regulatory determination or FONSI, substantially changing 

the proposed action identified in the EA, or substantially changing the analysis of impacts in the 

EA, USDA-APHIS’ preliminary regulatory determination becomes final and effective upon public 

notification through an announcement on its website. No further Federal Register notice is 

published announcing the final regulatory determination.

Approach 2: For GE organisms that raise substantive new issues not previously reviewed by 

USDA-APHIS.

A second approach for public participation is used when USDA-APHIS determines that the 

petition for a determination of nonregulated status is for a GE organism that raises substantive new 

issues. This could include petitions involving a recipient organism that has not previously been 

determined by USDA-APHIS to have nonregulated status or when USDA-APHIS determines that 

gene modifications raise substantive biological, cultural, or ecological issues not previously 

analyzed by USDA-APHIS. Substantive issues are identified by APHIS based on our review of the 

petition and our evaluation and analysis of comments received from the public during the 60-day 

comment period on the petition.

 

USDA-APHIS solicits comments on its draft EA and draft PPRA for 30 days through the 

publication of a Federal Register notice. USDA-APHIS reviews and evaluates comments and 

other relevant information, then revises the PPRA as necessary and prepares a final EA. Following 

preparation of these documents, USDA-APHIS approves or denies the petition, announcing in the 

Federal Register the regulatory status of the GE organism and the availability of USDA-APHIS' 

– 6 –
final EA, PPRA, NEPA decision document (either a FONSI or notice of intent (NOI) to prepare an 

EIS), and regulatory determination.

Enhancements to public input are described in more detail in the Federal Register notice published 

on March 6, 2012.

1.6 Public Comment Period for Petition 12-15-01p

USDA-APHIS decided this EA will follow Approach 1 because this is the second EA prepared for 

soybean genetically engineered for resistance to HPPD inhibitor herbicides and multiple others 

engineered for resistance to glufosinate (see Table 2-1, as ‘phosphinothricin’ resistant). The 

Syngenta petition was published for public comment on February 27, 2013, with comments 

accepted until April 29, 2013. A total of 28 public submissions were made to the docket. Some of 

the submissions to the docket contained multiple comments combined together gathered by 

organizations from their members. Counting these individual comments, the 28 submissions 

contained a total of 584 public comments. The public comments in response to the petition may be 

viewed at the federal website, regulations.gov. APHIS evaluated the issues raised and the 

submitted documentation. The majority of the comments expressed a general dislike of the use of 

GE organisms or were form letters with concerns about concerns for weed resistance, for the 

direction of modern farming, and for unknown health risks. Many of the unfavorable comments 

raise issues that are outside the scope of this EA. APHIS has included a discussion of issues 

relative to this petition in the EA or in the response to comments attached to the National 

Environmental Policy Act Decision and Finding of No Significant Impact document, posted at the 

federal website, regulations.gov. 

1.7 Issues Considered

The list of resources considered in this EA was developed in accordance with the requirements of 

NEPA and consistent with previous APHIS EAs regarding similar products. The evaluation 

considers potential environmental impacts to resources relevant to transgenic field crops like 

SYHT0H2 soybean, as well as concerns and issues raised in public comments submitted for other 

EAs of transgenic organisms. The evaluation also addresses concerns raised in previous and 

unrelated court decisions, as well as questions that have been raised by various stakeholders in the 

past. The resources considered in this EA are listed below.

 Soybean Production

o Acreage and areas of soybean production

o Agronomic practices

o Commercial soybean production and uses

o Seed production

o Raw and processed soybean commodities

o Organic soybean production

o Specialty soybean systems

– 7 –
 Physical Environment

o Soil

o Water quality and use

o Air quality

o Climate

 Natural Biological Communities (Non-target organisms)

o Animals

o Plants

o Soil microorganisms

o Biodiversity

o Gene movement in the natural environment

 Public Health

o Human health

o Animal (livestock) health

o Worker safety

 Socioeconomic Factors

o Domestic trade environment

o Foreign trade environment

o Social and economic environment

 Cumulative Effects

 Threatened and Endangered Species

– 8 –
2 AFFECTED ENVIRONMENT

This Chapter describes soybean biology, soybean production, and the environmental and human 

resources that could potentially be affected by a determination of nonregulated status for 

SYHT0H2 soybean.

2.1 Soybean Biology

Soybean is one of the oldest cultivated crops in the world (OECD, 2000a); it was domesticated in 

China sometime between the 17th and 11th centuries BC (Hymowitz, 1970). Soybeans were first 

introduced into the US in 1765 (Hymowitz, 1990). Soybeans yield oil for a variety of uses and 

meal for human food and livestock feed. They are the most extensively grown oilseed in the world, 

representing 56 percent of world oilseed seed production in 2011 (Soystats, 2012a).

Cultivated soybean, Glycine max (L.) Merr., is a diploidized tetraploid in the family Fabaceae, 

subfamily Papilionoideae, tribe Phaseoleae, genus Glycine Willd. and subgenus Soja (Moench) 

(OECD, 2000a). The subgenus consists of 12 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 (OECD, 2000a). G. max has never been found in the wild (Hymowitz, 

1970), and does not exist naturally anywhere. In addition to G. max, subgenus Soja subgenus also 

contains G. soja (OECD, 2000a). G. soja is the ancestor of G. max, and grows in fields, hedgerows, 

roadsides, and riverbanks in many Asian countries. Some taxonomists consider G. max and G. soja to 

be conspecific, as G. max ssp. soya and G. max ssp. max (Heatherly and Elmore, 2004). G. max has a 

relatively large seed size that does not produce a persistent seedbank, does not have wild or weedy 

compatible relatives in the US, and does not have feral populations in the US (Mallory-Smith and 

Zapiola, 2008), eliminating the potential for gene flow of transgenic traits to related species.

Domesticated soybean is a self-pollinated annual species, propagated commercially by seed 

(OECD, 2000a). Artificial hybridization is used for cultivar breeding (OECD, 2000a). Flowers are 

typically cleistogamous but, in some cultivars and under some conditions, may be chasmogamous 

and insects may transfer pollen (Erickson, 1975; Ahrent and Caviness, 1994; Ray et al., 2003; 

Chiari et al., 2005). Cross pollination is usually less than 1 percent under typical agricultural 

conditions (Caviness, 1966; Ray et al., 2003; Yoshimura et al., 2006) but may be higher in some 

cultivars, under some climatic conditions which favor chasmogamy. In experimental studies, 

outcrossing rates of 0.41 percent were found with a 90-cm row spacing and up to 6.3 percent with 

a 15-cm row spacing (Ray et al., 2003), and up to 2.5 percent outcrossing with a 102-cm row 

spacing (Ahrent and Caviness, 1994). Several studies of soybeans in Japan and China, using 

various DNA analysis methods (chloroplast DNA, single-sequence repeats, single-nucleotide 

polymorphism) have detected low levels of the G. max genome in some wild G. soja populations 

(Hasegawa et al., 1999; Kuroda et al., 2009; Li et al., 2010), attributed to post-domestication 

hybridization. A phenotypic analysis of G. soja populations in China suggested introgression with 

G. max (Wang et al., 2010). However, a study in Japan, under field conditions, did not detect any 

gene flow based on nuclear microsatellite data (Kuroda et al., 2009).

– 9 –
Soybean grows in a symbiotic association with the bacterium Bradyrhizobium japonicum

(Kirchner) Jordan, which carries out nitrogen fixation within the plant roots (Farooq and Vessey, 

2009). Similar to other legumes, soybeans develop root nodules to house B. japonicum in a 

microaerobic environment to produce nitrogenase, the enzyme complex responsible for nitrogen 

reduction in plants (Gage, 2004). Soybean can obtain up to 75 percent of its nitrogen requirements 

from the air via the nitrogen-fixing bacteria while providing the bacteria with carbohydrates 

(Pedersen, 2007). Because the nitrogen-fixing bacteria are not native to US soils and would not 

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

planting, especially if soybean has not been grown in the field for 3 to 5 years (Pedersen, 2007).

Soybean seeds will germinate when the soil temperature reaches 10°C (OECD, 2000a). The soybean 

plant responds strongly to day length in its phasic development (Hodges and French, 1985; 

Hymowitz, 1990). Soybeans are not frost tolerant, and they do not survive freezing winter conditions 

(OECD, 2000a). This erect, bushy herbaceous summer annual can reach a height of 5 feet (OECD, 

2000a). Under very dry conditions, water stress may affect development (Hodges and French, 1985).

In North America, soybeans are classified into 13 maturity groups (MGs) based upon the effects of 

day length on the time to the appearance of first flowers (Hymowitz, 1990). The MGs for soybean 

cultivars are based on bands of adaptation that run east-west across the continent, determined by 

latitude and day length: MG 000 is in the north (at 45° latitude) and MG X is near the equator. In 

Canada and northern parts of the US, most cultivars are indeterminate10 and have relatively short 

crop durations; they are classified as MG 000, MG 00, and MG 0 (Hymowitz, 1990). Cultivars 

from MG II, MG III, MG IV, and MG V are grown in the central US states. The cultivars adapted 

to the subtropical and tropical zones are often determinate,

11 have relatively long crop durations, 

and are classified in MG IX and MG X (Hodges and French, 1985; Helsel and Minor, 1993).

Transgenic soybean products were introduced in the US market by seed companies beginning in 

1996, adding new genetic traits such as pest resistance and herbicide tolerance to modern soybean 

varieties.12 In 2012, approximately 93 percent of soybean acreage was planted with transgenic 

varieties, virtually all being herbicide tolerant (USDA-NASS, 2012b). Transgenic soybean 

cultivars representing 17 different transformation events have been determined to have

nonregulated status by APHIS (USDA-APHIS, 2013a). Twelve of these cultivars are tolerant to 

herbicides, as listed in Table 2-1.

10 A growth characteristic by which a plant’s roots or meristem shoot can keep growing as long as it is alive.

11 A growth characteristic by which the plant stops growing after it reaches a certain size.

12 Some varieties of soybeans were developed through selection to display nontransgenic tolerance of certain herbicides.

– 10 –
Table 2-1. Transgenic Soybean Cultivars with Herbicide Tolerance Traits that are no 

longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest 

provisions of the Plant Protection Act of 2000.

Cultivar1

Filed By /

Petition Number Herbicide Tolerance

NEPA Status 

(by APHIS)

40-3-2 Monsanto /

petition 93-258-01p

Glyphosate FONSI and EA issued 

May 18, 1994

W62, W98, A2704-12,

A2704-21, A5547-35

AgrEvo2 /

petition 96-068-01p

Phosphinothricin3 FONSI and EA issued

August 13, 1996

A5547-127 AgrEvo /

petition 98-014-01p

Phosphinothricin FONSI and EA issued 

May 1,1998

GU262 AgrEvo /

petition 98-238-01p

Phosphinothricin FONSI and EA issued 

October 16, 1998

MON 89788 Monsanto /

petition 06-178-01p

Glyphosate FONSI and EA issued 

July 23, 2007

DP-356043 Pioneer /

petition 06-271-01p

Glyphosate and acetolactate 

synthase-inhibiting

FONSI and EA issued 

July 15, 2008

MON 87705 Monsanto /

petition 09-201-01p

Glyphosate FONSI and EA issued 

October 7, 2011

MST-FGØ72-2 Bayer CropScience / 09-

328-01p

Glyphosate and isoxaflutole FONSI and EA issued 

August 21, 2013

Source: (USDA-APHIS, 2013a)

1- Bold type denotes cultivars in commercial production in the US.

2- AgrEvo is now Bayer CropScience.

3- Phosphinothricin is also known as glufosinate or glufosinate-ammonium.

2.2 Agricultural Production of Soybean

This section describes areas and acreages of soybean production in the US, current agronomic 

practices, specialty production systems, raw and processed soybean commodities, and soybeans’ 

persistence in the environment and weediness potential.

2.2.1 Current and Projected Acreage and Range of Soybean Production

Historically, US soybean acreage reached 70 million acres in 1980 but declined to under 

60 million acres by 1989 (USDA-ERS, 2011c). Acreage expanded through the 1990s as federal 

farm program changes increased planting flexibility and encouraged more farmers to incorporate 

the crop in their rotations (USDA-ERS, 2011c). Planted soybean acreage in the US has been

relatively stable recently (USDA-NASS, 2012d). In 2012, 76.1 million acres of soybeans were 

planted in the US, up 1 percent from 2011 and the third highest on record (USDA-NASS, 

2012b). Total harvested acreage in 2012 was estimated to be 76.1 million acres (USDA-NASS, 

2013a), equivalent to the planted acreage, also the third highest on record, and up 3 percent from 

2011. As of March, planted soybean acreage for the 2013 season was forecasted to be 

77.1 million acres (USDA-NASS, 2013c), down slightly from 2012 but the fourth highest on 

record. Planted area is projected to be down across the Great Plains with the exception of North 

– 11 –
Dakota. The largest declines are expected in Nebraska and Minnesota, while Illinois and North 

Dakota are expecting the largest increases.

Fluctuations in soybean acreage are due to environmental, agronomic, and economic factors, as 

well as programs such as the USDA Conservation Reserve Program (CRP) or ethanol mandates 

imposed by the US government, which drive acreage into source crops for ethanol.

Growth in the US soybean industry could slow over the next 10 years as it faces stronger foreign 

competition and US farmers shift acreage into feed grains for economic reasons (USDA-ERS, 

2011c). Soybean planted acreage is expected to stabilize around 76 million acres in 2014 and 

remain at that level through 2019 (USDA-ERS, 2011c).

Soybean is profitably grown on high quality agricultural land (USDOE-EIA, 2007), much of 

which in the US is already committed to agricultural production (USEPA, 2007). In the 2007 

Census of Agriculture,13 the USDA Economic Research Service estimated that only 4.1 percent 

of US cropland was idle (USDA-NASS, 2009a). To satisfy greater soybean demand, additional 

soybean acreage is generally planted at the expense of alternative crops, such as cotton or hay, 

with minor contributions from land exiting CRP agreements (O’Donoghue et al., 2011) resulting 

in a decrease in total US agricultural acreage (USDOE-EIA, 2007). It is unlikely that previously 

uncultivated land will be managed for future soybean production; rather, increased soybean 

production will likely compete with other crops (USDA-ERS, 2011c).

Soybeans are cultivated in 31 states (USDA-NASS, 2012b). Table 2-2 presents an overview of 

the 2011 and 2012 acreage of soybeans planted by state. The top two producing states in 2012

were Iowa and Illinois, with 9.5 million and 8.6 million acres planted, respectively (USDANASS, 2012b). More than 80 percent of the US soybean acreage is concentrated in the upper 

Midwest (USDA-ERS, 2010a), between 35 and 45 degrees north latitude (Hymowitz, 1970).

Figure 2-1 depicts the soybean planted acreage by county in selected states based on 2010 data .

Soybean yield varies by region and variety. Soybean yields range from 26 to 47 bushels per acre, 

with a trend towards higher yields in recent years (USDA-ARS, 2006). The upward trend in 

yield is largely a result of new varieties that perform better under climate and pest pressures. The 

average yield per acre in 2012 was estimated at 39.6 bushels (USDA-NASS, 2013a), 2.3 bushels below 

the previous year’s yield.

13 The USDA-ERS conducts the Census of Agriculture every 5 years. The 2012 Census was conducted from December 

2012 through February 2013, and will be published at some future date. It is therefore not available for this report.

– 12 –
Table 2-2 Soybean Acreage by State, 2011 and 2012

State

Acres Planted (thousands)

2011 2012

Alabama 300 330

Arkansas 3,330 3,250

Delaware 170 180

Florida 18 25

Georgia 155 190

Illinois 8,900 8,600

Indiana 5,300 5,000

Iowa 9,350 9,500

Kansas 4,000 3,600

Kentucky 1,490 1,400

Louisiana 1,020 1,140

Maryland 470 480

Michigan 1,950 2,000

Minnesota 7,100 7,000

Mississippi 1,820 2,130

Missouri 5,350 5,300

State

Acres Planted (thousands)

2011 2012

Nebraska 4,900 5,100

New Jersey 88 95

New York 280 340

North Carolina 1,380 1,670

North Dakota 4,000 4,600

Ohio 4,550 4,600

Oklahoma 440 410

Pennsylvania 500 530

South Carolina 370 420

South Dakota 4,100 4,500

Tennessee 1,290 1,330

Texas 165 100

Virginia 560 550

West Virginia 20 20

Wisconsin 1,610 1,690

Total Acreage 74,976 76,080

Source: (USDA-NASS, 2012b)

2.2.2 Agronomic Practices

Soybean growers choose agronomic practices that have economic or environmental benefits. Cropping 

practices include planting cover crops, rotating crops, and using a variety of tillage techniques to 

maximize yield, control weeds or other pests, and minimize environmental impacts. Other agronomic 

practices include supplemental irrigation and pest (insect, disease, and weed) management. 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. While agronomic practices may be dependent on the soybean maturity 

group and variety cultivated, common management strategies are shared across regions.

In this EA, conventional farming is defined as any farming system where synthetic pesticides or 

fertilizers may be used. Conventional farming covers a broad scope of farming practices, such as

occasional use to regular inputs of synthetic pesticides and fertilizers. Given that most soybeans 

planted in the US are transgenic, conventional farming now also includes the use of genetically 

engineered varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or 

the plant pest provisions of the PPA. 

– 13 –
Figure 2-1 Soybeans Planted Acres in 2010 by County for Selected States

As described in Section 2.1, soybean varieties in specific maturity groups are developed and 

adapted to certain geographical zones (Helsel and Minor, 1993). Additionally, genetically 

engineered herbicide-tolerant soybean varieties represent the most common soybeans cultivated in 

the US, accounting for 93 percent of soybean varieties planted in 2012 (USDA-NASS, 2012b). 

The broad adoption of genetically engineered herbicide-tolerant soybean varieties is attributed to 

simplified herbicide application practices and positive contributions to productivity and yield

(Carpenter and Gianessi, 1999; Fernandez-Cornejo and McBride, 2000). Among the various 

genetically engineered herbicide-tolerant soybean varieties commercially available, glyphosatetolerant varieties represent the vast majority that are planted in US soybean fields (NRC, 2010).

2.2.2.1 Cropping Practices

Although the US Midwest is referred to as the Corn Belt, soybeans are commonly planted in this 

region as well. Rotating corn with soybean supplies the biodiversity, nutrients, and ideal temporal 

sequence that make corn agriculture successful (Gardner and Payne, 2003). Other soybean 

cropping practices that directly or indirectly benefit both soybeans and corn include cover crops

and tillage and planting techniques.

– 14 –
Crop Rotation

Soybean crop rotation can improve yield and profitability over time, control weeds, break disease 

cycles, limit insect and other pest infestations, provide an alternative source of nitrogen, reduce soil 

erosion, increase soil organic matter, improve soil tilth, limit the potential for weeds to develop 

tolerance to herbicides, and reduce runoff of nutrients and chemicals, as well as the potential for 

contamination of surface water (Al-Kaisi et al., 2003). Crop rotation also affects the densities of 

soilborne pathogens and antagonistic microorganisms (Garbeva et al., 2004).

The majority of the US soybean acreage (nearly 70 percent) is rotated with corn (Heatherly et al., 

2009) in a 2-year cycle. Other crops in rotation with soybean are wheat, cotton, rice, and sorghum

(see Table 5.5). Minor rotational crops that follow soybean production include barley, oats, and dry 

beans. The crop rotation sequence can be modified to take advantage of a particular economic or 

market opportunity.

Approximately 15 percent of the soybean acreage is in continuous (i.e., non-rotation) soybean 

production, a practice that is discouraged by most soybean specialists (Quinby et al., 2006). 

Planting soybeans after soybeans each year increases the incidence of diseases, nematodes, soil 

insects, and possibly herbicide residues (Al-Kaisi et al., 2003; Whitaker et al., 2010). The result is 

generally decreased yields or increased production costs.

Cover Crops

Using cover crops in a soybean system has environmental benefits in conserving and/or improving 

soil and water resources (Heatherly et al., 2009) by reducing erosion and sequestering nutrients

(Mischler et al., 2010), but does not necessarily result in increased soybean yield. Cover crops may 

be grown in the soybean off-season or simultaneously for managing weeds (Mischler et al., 2010)

by competing for limited resources such as sunlight and nutrients, and by suppressing weed 

emergence when mulched. In the Corn Belt, cover crops are used on approximately 10 percent of

soybean fields; winter wheat, cereal rye, and oats are the species most used (Heatherly et al., 2009).

Tillage and Planting Techniques

Prior to planting, soil must be stripped of weeds that would otherwise compete with soybean for space, 

water, and light. As described in Section 2.2.2.5, Management of Weeds, tillage is an economical 

means of removing biennial and perennial weeds (Byrd et al., 2003) and reincorporating crop residue 

into the soil. Crop residues are materials left in a field after the crop has been harvested, including stalks 

and stubble (stems), leaves and seed pods (USDA-NRCS, 2005). These residues aid in conserving soil 

moisture and reduce wind- and water-induced soil erosion (Heatherly et al., 2009) (USDA-NRCS, 

2005). In conventional tillage, postharvest crop residue is integrated into the soil using moldboard 

plows, heavy disks, and chisel plows, leaving less than 15 percent of crop residue on the surface to 

prepare a clean bed for planting and to reduce the growth of weeds (Heatherly et al., 2009).

Conservation tillage employs methods that disturb soil less and leave more crop residues on the 

surface (at least 30 percent), whereas no-till farming only disturbs the soil for planting seed (USDANRCS, 2005). Conservation tillage (including no-till farming) results in decreased soil erosion, 

dust, and pesticide run-off and in increased soil moisture retention and improved air and water 

– 15 –
quality. Conservation tillage also conserves fuel and water, but may rely heavily on chemical weed 

control (Loux et al., 2008). Above average management is required to attain good crop stands and 

weed control (Whitaker et al., 2010).

Since the 1990s, no-till farming has increased more than any other reduced tillage system, with 

nearly all of the increase in adoption occurring in herbicide-tolerant crop production (i.e., soybean, 

cotton, canola) (Fawcett and Towery, 2002). In a survey conducted in 1997, it was found that farmers 

already using no-till practices were more likely to adopt herbicide-tolerant soybeans as an effective 

weed control practice than farmers using conventional tillage techniques, although the study also 

found that the commercialization of herbicide-tolerant soybean did not itself encourage the adoption 

of no-till practices (Fernandez-Cornejo and McBride, 2000). A subsequent survey conducted 

between 1996 and 2001 found that growers using herbicide-tolerant seed varieties were more likely 

to use conservation tillage practices over conventional methods and to practice conservation tillage to 

a greater degree than growers that did not use herbicide-tolerant crops (Fawcett and Towery, 2002). 

A survey of 1,195 producers undertaken between November 2005 and January 2006 revealed that 

25 percent of farmers that had been using conventional tillage switched to no-till and 31 percent

switched to reduced-till after adopting glyphosate-tolerant genetically engineered crops (Givens et 

al., 2009). According to the USDA Agricultural Resource Management Survey (ARMS), 

approximately 35 percent of US cropland (88 million acres) planted to eight major crops used no-till

practices in 2009, and that percentage appears to be increasing over time (USDA-ERS, 2012d). 

USDA data indicate that soybean fields, 93 percent of which are planted with herbicide tolerant 

transgenic varieties, exhibit the highest rate of no-till adoption of major crops, increasing from 35 to 

45 percent between 2002 and 2006 (the latest data available) (USDA-ERS, 2013a).

In summary, the trend of increasing adoption of conservation tillage practices by US soybean 

growers continued following the introduction of glyphosate-tolerant soybean in 1996. Conservation 

tillage adoption facilitates broad-spectrum herbicide use, due to the capacity of these herbicides to 

control a variety of weed populations prior to planting a crop. Though the causality between 

herbicide-tolerant soybean adoption and conservation tillage may be debated (Fernandez-Cornejo et 

al., 2002), most evidence suggests a relationship between grower adoption of herbicide-tolerant crops 

and conservation tillage (NRC, 2010).

Soybean planting techniques commonly include row spacings of 36 inches (OECD, 2000a). 

Narrower row spacings (20 to 30 inches) help insure full canopy development, which can reduce 

soil moisture loss and suppress late emerging weeds (Whitaker et al., 2010). In new areas of 

soybean production, growers may inoculate with B. japonicum for optimum efficiency of the 

nodulated root system. Other considerations made by farmers regarding planting and tilling are 

seasonal or regional:

• Adequate soil moisture and warm temperatures facilitate rapid seed germination and 

emergence. However, waiting for soils to reach the ideal soil temperature will delay planting 

beyond the optimum planting date that will maximize yield (Pedersen and Lauer, 2004).

• Planting date has the greatest impact on yield. In the upper Midwest states, highest yields are 

generally obtained when planting is done in early to mid-May (Pedersen and Lauer, 2004). In 

the Southern US, yields are highest when soybean is sown in May or early June.

– 16 –
• The early soybean production system (ESPS) consists of planting an early-maturing soybean

variety 4 to 6 weeks before common late-maturing varieties to reduce the risk of drought 

stress that often occurs during July through September in Southern US states (McPherson et 

al., 2001; Whitaker et al., 2010). Early planting also helps avoid harvesting the crop during 

excessively wet conditions that can occur during the fall.

2.2.2.2 Irrigation

The general water requirement for a high-yielding soybean crop (40 to 50 bushels per acre) is 

approximately 20 to 25 inches of water during the growing season (UA, 2006). Irrigation can 

alleviate the effects of drought stress, which is the most damaging abiotic stress to soybean in the US

(Heatherly et al., 2009). Extended drought during the "critical fruiting period" in dryland farming can 

result in yield variation from about 5 to 50 bushels per acre (Whitaker et al., 2010). Timely irrigation 

can stabilize soybean yields at 45 to 50 bushels per acre or more, and improve average yields about 

20 bushels per acre (Whitaker et al., 2010).

Irrigated soybean systems are the most productive in the US, providing consistent and sustainable 

soybean production in the long term (Heatherly et al., 2009). When irrigation is combined with 

crop rotation, net returns in soybean-corn or soybean-wheat sequences are greater than nonirrigated 

or irrigated continuous soybean systems (Heatherly et al., 2009). In 2006, an average of 

approximately 8.4 inches of water per irrigated acre was used, producing an average of over 

51 bushels of soybeans per irrigated acre (USDA-ERS, 2012e). This yield was approximately 

19 percent higher than the national average (42.9 bushels per acre) for that year (USDA-NASS, 

2011a).

Over 9 percent of the soybean crop in the US is irrigated (USDA-NASS, 2010). The majority of 

the irrigated soybean acreage is in the Midwestern and Midsouthern states, as depicted in Figure 2-

2, where summer weather patterns may result in drought stress that makes dryland production risky

(Heatherly et al., 2009). Approximately 73 percent of irrigated soybean farms occur in the

Missouri and Lower Mississippi Water Resource Regions, with soybean farms in the states of

Nebraska, Arkansas, Mississippi, Missouri, and Kansas accounting for 85 percent of all irrigated 

acres (USDA-NASS, 2010). The soils and climate in the Eastern, Midwestern, and portions of the 

Great Plains region of the US provide sufficient water supplies under normal climatic conditions to 

produce a soybean crop.

– 17 –
Figure 2-2 Irrigated Soybeans for Beans; Harvested Acres in 2007

2.2.2.3 Fertilization

USDA-ERS estimates that less than 40 percent of soybean acres in the US receive nitrogen 

fertilizer (USDA-ERS, 2012g). A 2006 survey of 19 states (USDA-NASS, 2007) found that 

nitrogen, phosphate, potash, and sulfur were applied to soybeans as summarized in Table 2-3.

Table 2-3 Fertilizer Primary Nutrient Applications to Soybeans in 2006

Primary 

Nutrient

Area Applied 

(percent)

Applications 

(number)

Rate per 

Application 

(lb/A)

Rate per Crop 

Year (lb/A)

Total Applied 

(millions of 

pounds)

Nitrogen 18 1.1 15 16 212.4

Phosphate 23 1.0 45 46 772.8

Potash 25 1.0 79 80 1,454.7

Sulfur 3 1.1 10 11 20.0

Source: (USDA-NASS, 2007)

Note: States surveyed: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, 

North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Virginia, and Wisconsin; totaling 72.9 million acres. 

– 18 –
Soybeans may remove up to 70 pounds of nitrogen from the soil when a 50-bushel yield of 

soybean is attained (Hoeft et al., 2000). The nitrogen requirement of soybean is often provided 

through fertilization of the previous rotation crop or through the symbiotic relationship with 

nodulating bacteria in root tissue (Ferguson et al., 2012). Given the important role of these bacteria 

for meeting nitrogen needs of soybean, nodulating bacteria inoculants are often applied to soybean 

seeds just before planting (Beuerlein, 2005).

2.2.2.4 Management of Insects

US soybean fields generally face little economic pest pressure from insects, due in large part to the 

capacity of soybeans to experience limited insect herbivory without a reciprocal loss in grain yield 

(PSE, 2011). This recalcitrance to insect damage is evident in the low use of insecticides on 

soybean fields. Historically, only about 2 percent of US soybean acres were treated with 

insecticides (Gianessi, 2009). However, since the advent of the soybean aphid in 2000 in the 

Midwest, approximately 16 percent of US soybean acres have been treated with insecticides 

(USDA-ERS, 2012e).

Numerous kinds of insects occur in soybean fields; most are beneficial or harmless, but some can 

cause yield loss and even crop failure if not controlled. Insect pests are capable of severely 

damaging soybeans through defoliation and pod eating (Whitaker et al., 2010). The soybean aphid 

eats stems; heavy infestations of this pest have occurred since 2000 and caused economic yield 

losses up to 45 percent in some untreated fields (Gianessi, 2009). The most damaging defoliators 

are velvetbean caterpillar, soybean looper, green cloverworm, Mexican bean beetle, and bean leaf 

beetle. Foliage-eating insects are present in practically all soybean fields throughout the growing 

season, but most fields suffer no yield loss since the number of foliage feeders usually remains at 

low to moderate levels (NCCES, 2012). The most damaging pod feeders are southern green stink 

bug, green stink bug, corn earworm, and bean leaf beetle (Gianessi, 2009). Insects which attack the 

pods are the major reason for treating soybeans with insecticides (NCCES, 2012).

Soybean growers have several tools available to manage insects; integrated pest management 

approaches incorporate two or more of these tools:

• Soybean varieties with native resistance to some insect pests are available.

• Natural enemies provide considerable control of insect pests in most regions (Gianessi, 

2009); beneficial pests that prey on targeted insects may be introduced by the grower;

• Conventional chemical insecticides afford consistent, economical, and effective suppression 

of insect outbreaks on soybean (Gianessi, 2009); and

• Trap cropping has been proven to be a cost effective means of managing insects in soybeans 

(Whitaker et al., 2010). Soybean field borders are planted using a soybean variety at least two 

maturity groups earlier than the rest of the field. Treating only the trap area for pest insects 

controls the pest without disrupting beneficial insect populations in the rest of the field.

Insect infestation thresholds have been established to indicate when insecticide applications are 

necessary (Higgins, 1997). The thresholds are commonly based on number of insects found in field 

– 19 –
sampling surveys and/or in established standard defoliation thresholds, such as those provided by the 

National Information System of the Regional Integrated Pest Management Centers in pest 

management strategic plans (USDA-NIFA, 2012).

Table 2-4 presents summary data of the latest available chemical insecticide usage statistics for US 

soybeans from a 2006 survey (USDA-NASS, 2007). The survey found that insecticides were applied 

to 16 percent of the 72.9 million soybean acres planted in the surveyed states. No single insecticide 

exceeds 6 percent of chemically treated acreage (USDA-NASS, 2007). Of the 12 reported 

insecticides, the three most common (lambda-cyhalothrin, chlorpyrifos, and esfenvalerate) were 

applied to 6 percent, 5 percent, and 3 percent of the planted acres, respectively (USDA-NASS, 2007).

Table 2-4 Insecticide Applications to Soybeans in 20061

Insecticide

Area 

Applied 

(percent)

Average 

Number of 

Applications 

Rate per 

Application 

(lb/A)

Rate per Crop 

Year (lb/A)

Total Applied 

(millions of 

pounds)

Acephate 1 1.3 0.72 0.934 0.546

Benzoic acid <0.5 1.1 0.051 0.056 0.009

Carbaryl <0.5 1 0.633 0.633 0.091

Chlorpyrifos 5 1.1 0.454 0.48 1.663

Cyfluthrin <0.5 1.1 0.028 0.03 0.01

Diflubenzuron <0.5 1.7 0.037 0.062 0.01

Esfenvalerate 3 1.1 0.035 0.037 0.07

Gamma-cyhalothrin <0.5 1 0.011 0.011 0.003

Lambdacyhalothrin 6 1.1 0.02 0.021 0.097

Methyl parathion <0.5 1.1 0.529 0.565 0.066

Permethrin <0.5 1 0.065 0.065 0.012

Thiodicarb <0.5 1 0.32 0.32 0.039

Zeta-cypermethrin 1 1 0.022 0.022 0.014

Source: (USDA-NASS, 2007)

1- States surveyed: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North 

Carolina, North Dakota, Ohio, South Dakota, Tennessee, Virginia, and Wisconsin; totaling 72.9 million acres. 

2.2.2.5 Management of Disease and Other Non-Insect Pests

Other economically important pest problems for soybeans include a wide range of fungi, bacteria,

nematodes, and viruses (Carpenter et al., 2002; Whitaker et al., 2010). Soybean foliar diseases 

(ISUE, 2010) include:

• Alfalfa mosaic virus

• Bacterial blight (Pseudomonas syringae)

• Bacterial pustule (Xanthomonas axonopodis pv. glycines)

• Bean pod mottle virus

• Cercospora leaf blight and purple seed stain (Cercospora kikuchii)

– 20 –
• Downy mildew (Peronospora manshurica)

• Frogeye leaf spot (Cercospora sojina)

• Phylosticta leaf spot (Phylosticta sojicola)

• Powdery mildew (Microsphaera diffusa)

• Septoria brown spot (Septoria glycines)

• Soybean mosaic virus

• Soybean rust (Phakopsora pachyrhizi)

Soybean stem and root diseases (ISUE, 2010) include:

• Anthracnose stem blight (Colletotrichum truncatum and several related species)

• Brown stem rot (Phialophora [Cadophora] gregata)

• Charcoal rot (Macrophomina phaseolina)

• Fusarium wilt and root rot (Fusarium species)

• Phytophthora root and stem rot (Phytophthora sojae)

• Pod and stem blight and Phomopsis seed decay (Diaporthe phaseolorum var. sojae and 

Phomopsis longicolla)

• Pythium root rot (Pythium species)

• Rhizoctonia root rot (Rhizoctonia solani)

• Sclerotinia stem rot (white mold) (Sclerotinia sclerotiorum)

• Soybean cyst nematode (Heterodera glycines)

• Stem canker (Diaphorthe phaseolorum var. caulivora [northern stem canker] and D. 

phaseolorum var. meridionalis [southern stem canker])

• Sudden death syndrome (Fusarium virguliforme)

Some plant diseases can be prevented or managed by planting disease resistant cultivars. Besides 

selecting cultivars with resistance to diseases prevalent in a grower’s particular region (Dorrance et

al., 2007), a healthy soybean crop starts with planting disease-free seed (Jardine, 1997), 

implementing best management practices such as crop rotation to reduce disease carryover from 

crop to crop, and providing adequate nutrients and water to grow healthy plants (Nelson, 2011). 

Tillage practices can also affect disease risk: no-till soils may have higher soil moisture and lower 

soil temperatures than could increase risk. Tilling may improve drainage to lower risk, but 

conservation tillage practices should be used to maintain soil quality (ISUE, 2010). Conversely, 

some infestations, such as of soybean cyst nematode, may be managed by no-till methods. A 

grower may chose to plant seeds treated with fungicides to enhance soybean seed germination 

success (Jardine, 1997).

When diseases of fungal origin do occur despite taking such measures, fungicides are used (Jardine, 

1997; Padgett et al., 2011). The most commonly applied fungicides on soybean (azoxystrobin,

propiconazole, pyraclostrobin, tebuconazole, and trifloxystrobin) were applied to only 4 percent of 

the planted soybean acreage in the 19 states surveyed in 2006 (USDA-NASS, 2007). Of these 

fungicides, pyraclostrobin and azoxystrobin were the only two applied on more than 0.5 percent of 

the planted acres. Pyraclostrobin was applied to 2 percent of the planted acres at an average rate of 

0.112 lb/A per year, whereas azoxystrobin was applied to 1 percent of planted acres at an average 

rate of 0.106 lb/A per year (USDA-NASS, 2007).

– 21 –
Some varieties of soybeans are more susceptible to certain bacterial or viral diseases than others, 

and resistant varieties are marketed as such (ISUE, 2010). Bacterial and viral diseases may be 

transmitted by aphids (such as Aphis glycines) or bean leaf beetles (Cerotoma trifucata). 

Insecticides may be effective in controlling these insects, as described in Section 2.2.2.4, 

Management of Insects, and therefore minimize disease transmittal from these vectors. Some 

diseases may be transmitted in or on seeds; fungicide-treated seeds are available to growers.

2.2.2.6 Management of Weeds

Weed control is one of the biggest challenges for soybean growers; poorly controlled weeds 

substantially decrease crop yield and quality (Carpenter et al., 2002) since weeds compete with 

soybeans for light, nutrients, and soil moisture. Weeds can harbor insects and diseases, and can 

interfere with harvest, causing extra wear on harvest equipment (Loux et al., 2008). Soybean yield 

losses can range from 12 to 80 percent if weeds are uncontrolled for an entire season (Barrentine, 

1989; Dalley et al., undated).

If weeds are left uncontrolled, soybean cannot be grown economically (Hartzler, 2012). Growers 

make choices to use certain herbicides based on weed, insect and disease pressures, cost of seed 

and other inputs, technology fees, fuel costs, worker safety, potential for crop injury, and ease and 

flexibility of the system (Gianessi, 2005). Glyphosate-tolerant soybeans have allowed growers to 

use a broad spectrum herbicide, glyphosate, in place of an array of over 70 selective herbicides 

targeted toward specific weeds. Recent trends suggest a decrease in glyphosate use and slight 

increase in selective herbicide use, as described in the Herbicide discussion below.

The primary factors affecting soybean yield loss from weed competition are the species, density, 

and the duration and time period of the competition. The later the weeds emerge, the less impact 

the weeds will have on yield. Soybean plants withstand early-season weed competition longer than 

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

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

below the soybean. Canopy closure occurs much sooner when soybean is drilled or planted in 

narrow rows as compared to the standard 36-inch row spacing.

Problem weed species in US soybean fields include common cocklebur (Xanthium strumarium), 

jimsonweed (Datura stramonium), velvetleaf (Abutilon indica or A. theophrasti), morning glories 

(Ipomoea spp.), Johnsongrass (Sorghum halapense), and foxtails (Setaria spp.) (Carpenter et al., 2002).

Growers in the Midwest consider giant ragweed (Ambrosia artemisiifolia), lambsquarters 

(Chenopodium album), Canada thistle (Cirsium arvense), common cocklebur, and velvetleaf to be the 

top five most problematic weeds in corn and soybean (Nice and Johnson, 2011). The most frequently 

reported common weeds in the Southeast region are morning glory, prickly sida (Sida spinosa), 

Johnsongrass, sicklepod (Cassia obtusifolia), and broadleaf signalgrass (Brachiaria platyphylla)

(Webster, 2005). Soybean itself may be considered a weed when volunteers grow in crop rotation fields 

in subsequent years; herbicide-tolerant soybean does not have any characteristics that promote 

volunteerism.

An important concept in weed control is the seed bank, which is the reservoir of seeds that are in

the soil and have the potential to germinate. In one survey of agricultural soils, reservoirs of weed

– 22 –
seeds were found to range from 4,100 to 137,700 seeds per square meter of soil (May and Wilson, 

2006). Climate, soil characteristics, cultivation, crop selection, and weed management practices 

affect the seed bank composition and size.

Soybean growers can use a variety of weed control strategies, but the most effective weed 

management programs have used a combination of cultural (cropping practices), mechanical, and 

chemical control strategies (Whitaker et al., 2010) in an Integrated Weed Management approach. 

The effectiveness of any weed control program depends largely upon timeliness (Loux et al., 

2008). Good weed control within the first 4 to 6 weeks after crops are planted is critical in order to 

avoid a yield reduction from weed competition. Weeds that emerge just prior to or at the same time 

as the soybeans cause greater yield losses than later emerging weeds (Whitaker et al., 2010).

Volunteer soybeans, if herbicide-tolerant, would be controlled by cultural and mechanical means.

With increased rates of conservation tillage, there has been a decrease in summer annual weeds and 

an increase in perennial, biennial, and winter annual weed species (Green and Martin, 1996; 

Durgan and Gunsolus, 2003) that are not controlled by limited-tillage practices. Winter perennial

weeds are particularly competitive and difficult to control, as these weeds regrow every year from 

rhizomes or root systems. Recent surveys of US agronomic crop producers suggest that pigweed 

species (Amaranthus spp.), morning glory species, Johnsongrass, ragweed species (Ambrosia spp.), 

foxtail species, and velvetleaf are among the most problematic weeds (Heatherly et al., 2009).

Cropping Practices for Weed Control

Cropping practices, as described in Section 2.2.2.1, improve weed control by enhancing the 

competitive ability of the soybeans. Any practice that optimizes early and vigorous crop growth helps 

give crops a competitive edge over weeds (Loux et al., 2008). Crop rotation is one of the most effective 

practices for long-term weed control (Loux et al., 2008). Crop rotation aids in controlling weeds by 

allowing rotation of herbicides with alternative modes of action appropriate for the alternating crops, 

and providing the opportunity to plant highly competitive crops that prevent weed establishment. 

However, crop rotation is not effective against seedbanks for all weed species (Jordan et al., 1995).

Soybeans planted in narrow rows, 15 inches or less wide, may have benefits such as higher yield 

potential and increased crop competitiveness with weeds (Dalley et al., undated). Planting crops in 

narrow rows increases the amount of shading by the crop canopy, suppressing weed growth. A cover 

crop grown simultaneously performs similarly and can help reduce herbicide inputs (Mischler et al., 

2010).

Herbicides

Herbicides provide effective and economical control of weeds in soybean that cultivators cannot 

reach (Byrd et al., 2003). Often the combination of shallow, flat cultivation with directed herbicide 

sprays is the least expensive and most effective weed treatment. Herbicides are applied at various 

points of the growing season (Carpenter et al., 2002):

• Pre-plant (during field preparation);

• Pre-emergence (during or immediately after planting); and

• Post-emergence (during crop growth).

– 23 –
A traditional soybean weed control program includes a pre-emergence herbicide application 

followed by one or more post-emergence applications about 4 to 6 weeks after the crop has 

emerged (Byrd et al., 2003). Yield losses from weed competition may occur when herbicide 

application is delayed (Dalley et al., undated). A timely application of a post-emergent herbicide in 

narrow row soybeans may be sufficient for season-long weed control.

The efficacy of herbicides is influenced by environmental and soil conditions, specifically 

precipitation and soil composition (Stewart et al., 2010). In selecting an herbicide, a grower must 

also consider whether an herbicide can legally be used on the crop (herbicides are registered by the 

EPA for specific uses/crops; some states evaluate and authorize or prohibit the use of herbicides 

separately), the potential adverse effects on the crop, residual effects that can limit crops that can 

be grown in rotation, effectiveness on expected weeds, and cost. Herbicide use is not regulated by 

APHIS but is regulated by EPA under FIFRA and its amendments.

Herbicides have different ways of acting on plant physiology (i.e., modes of action) to affect the 

health of a given plant and are active at one or more target sites within a plant (Prather et al., 2000). 

Target sites are enzymes, proteins, or places in the plant where herbicides bind and thereby disrupt 

normal plant functions. Some common modes of herbicide action include auxin growth regulators,

amino acid inhibitors, chlorophyll pigment inhibitors, lipid biosynthesis inhibitors, and glutamine 

synthase inhibitors (UW, undated).

By the early 1990s, there were over 70 individual herbicides or combination products registered for 

weed control in soybean (Byrd et al., 2003). At that time, pre-emergence herbicides commonly used 

on soybean were 2,4-dichlorophenoxy acetic acid (2,4-D), chlorimuron, metolachlor, metribuzin, 

pendimethalin, and trifluralin. Commonly used soybean post-emergence herbicides included

acifluorfen, basagran, bentazon, clethodim, cloransulam, fluazifop, fomesafen, glyphosate, 

imazethapyr, quizalofop, and sethoxydim. These herbicides typically control either broadleaf or grass 

species, but rarely both. Several species of weeds are usually present in any particular field and 

growers need to control both grassy and broadleaf weeds using different herbicides (Carpenter et al., 

2002). A combination of herbicides may be necessary, but tank mixing some herbicides can result in 

antagonism between the compounds. Sequential spraying may be required, in some cases 

necessitating multiple passes to apply the different herbicides.

Table 2-5 lists the most commonly applied herbicides to US soybeans and the corresponding 

percent of acres treated in 1995 (USDA-NASS, 1996), in comparison to use of these herbicides in

2001 (USDA-NASS, 2002), and 2006 (USDA-NASS, 2007)

14. Figure 2-3 graphs the usage trends 

of the top 10 herbicides from 1995 in terms of percent planted acres treated in t`hose same 3 years. 

Glyphosate has become the most often-used herbicide on US soybean. The graph shows that from 

1995 to 2006 glyphosate-applied acres increased to 92 percent in 2006 but also that the number of 

acres to which other herbicides were applied significantly declined (NRC, 2010).

14 USDA-NASS no longer collects these data. 

– 24 –
Table 2-5. Percent of US Soybean Acres1 Treated With Herbicides; 1995, 2001, 2006, 2012

Herbicide

Percent Soybean 

Acres Treated per 

Year

Percent Soybean 

Acres Treated per 

Year

1995 2001 2006 2012 Herbicide 1995 2001 2006 2012

2,4-D2 10 4 3 4 Fluthiocetmethyl-- -- 2

2,4-DB3 1 <1 <1 -- Glufosinate -- -- 3

2,4-DEHE 7 11 Glyphosate 20 73 92 98

Acifluorfen 12 3 <1 1 Imazaquin 15 2 1 --

Alachlor 4 <1 <1 -- Imazethapyr 44 9 3 6

Bentazon 12 1 <1 -- Lactofen 5 1 <1 2

Chlorimuronethyl16 5 4 11 Linuron 2 -- -- --

Clethodim 5 4 3 9 Metolachlor, 

(S)Metolachlor

7 <1 -- --

Clomazone 4 <1 -- -- Metribuzin 11 2 2 3

Dimethenamid 1 -- -- 1 Paraquat 2 -- 1 3

Ethalfluralin 1 -- -- Pendimethalin 26 10 3 2

Fenoxapropethyl6 3 <1 -- Quizalofop-ethyl 6 <1 <1 2

Fluazifop-Pbutyl10 3 1 3 Sethoxydim 7 1 <1 --

Flumetsulam 2 <1 <1 -- Thifensulfuron 12 2 1 5

Fomesafen 4 7 2 8 Trifluralin 20 7 2 2

Sources: (USDA-NASS, 1996; USDA-NASS, 2002; USDA-NASS, 2007; USDA-NASS, 2013a)

1- Survey states: 

1995: Arkansas, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Carolina, 

Ohio, and Tennessee.

2001: Arkansas, Illinois, Indiana, Iowa, Minnesota, Missouri, Nebraska, and Ohio.

2006: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North 

Carolina, North Dakota, Ohio, South Dakota, Tennessee, Virginia, and Wisconsin.

2012: Alabama, Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, 

Nebraska, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Wisconsin.

2- Dimethylamine salt formulation of 2,4-dichlorophenoxy acetic acid

3- 4-(2,4-dichlorophenoxy)butyric acid

-- = no value.

4-2-ethylhexyl ester

While total herbicide use trends are subject to debate, it is clear that an herbicide-substitution effect 

has occurred in US soybean production (Benbrook, 2009; Fernandez-Cornejo et al., 2009). With 

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

increased use of glyphosate for soybeans concurrent with the increased planting of glyphosatetolerant soybean. Although other herbicide-tolerant soybeans are cultivated, glyphosate-tolerant 

varieties continue to dominate the market in the US. Glyphosate is the active ingredient in a broadspectrum Roundup® herbicide introduced by Monsanto in 1974 (Monsanto, 2005). It works by 

– 25 –
disrupting the 5-enolpyruvylshikimate 3-phosphate (EPSP) synthase enzyme, which is involved in 

the production of amino acids that are essential to plant growth. Glyphosate products are among the 

world’s most widely used herbicides.

Figure 2-3 Percent of US Soybean Acres Treated with the 10 Most Used Herbicides; 

1995, 2001, and 20061

Source: (USDA-NASS, 2007)

1- Survey states: 

1995: Arkansas, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Carolina, Ohio, 

and Tennessee.

2001: Arkansas, Illinois, Indiana, Iowa, Minnesota, Missouri, Nebraska, and Ohio.

2006: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North 

Carolina, North Dakota, Ohio, South Dakota, Tennessee, Virginia, and Wisconsin.

In 2006 (the latest year for which data are available), based on soybean farmers surveyed in 

selected states, it was estimated that 98 percent of the planted soybeans were treated with at least 

one type of herbicide, indicating the importance of weed control in maximizing soybean yield. As 

shown in Table 2-6, application rates ranged from 0.004 to 1.931 lbs/A per crop year (USDANASS, 2007). Table 2-7 lists the most common troublesome weeds in herbicide-treated soybean 

fields in 2006, 2007, and 2008, and the number of acres treated with herbicides each year.

– 26 –
Table 2-6 Total Applications of Herbicides to Soybeans, 20061

Herbicide

Area 

Applied 

(percent)

Applications 

(number)

Rate per 

Applications 

(lb/A)

Rate per 

Crop Year 

(lb/A)

Total 

Applied 

(1,000 lb)

2,4-D (2-EHE) 7 1.0 0.493 0.503 2,505

2,4-D (BEE) <0.5 1.1 0.426 0.459 68

2,4-D (DMA) 3 1.0 0.462 0.475 953

Acifluorfen, sodium <0.5 1.0 0.287 0.296 47

Alachlor <0.5 1.0 1.931 1.931 485

Bentazon <0.5 1.0 0.687 0.687 70

Carfentrazone-ethyl <0.5 1.2 0.038 0.046 10

Chlorimuron-ethyl 4 1.0 0.017 0.017 52

Clethodim 3 1.1 0.096 0.102 190

Cloransulam-methyl 1 1.0 0.019 0.019 17

Dicamba, digly salt <0.5 1.0 0.250 0.250 16

Fenoxaprop <0.5 1.0 0.031 0.031 9

Fluazifop-P-butyl 1 1.0 0.099 0.099 43

Flufenacet <0.5 1.0 0.265 0.265 80

Flumetsulam <0.5 1.0 0.048 0.048 8

Flumiclorac-pentyl 1 1.4 0.020 0.028 17

Flumioxazin 3 1.0 0.066 0.066 138

Fomesafen 2 1.2 0.190 0.233 330

Glyphosate 4 1.7 0.630 1.044 2,841

Glyphosate, ammonium salt <0.5 1.5 0.489 0.745 142

Glyphosate, isopropyl amine salt 92 1.7 0.802 1.330 88,903

Imazamox <0.5 1.0 0.030 0.030 9

Imazaquin 1 1.0 0.061 0.062 66

Imazethapyr 3 1.0 0.053 0.053 100

Imazethapyr, ammonium <0.5 1.0 0.048 0.048 5

Lactofen <0.5 1.0 0.110 0.110 23

(S)-Metolachlor 1 1.0 1.023 1.023 837

Metribuzin 2 1.0 0.255 0.260 437

Paraquat 1 1.0 0.492 0.511 335

Pendimethalin 3 1.0 0.920 0.926 1,894

Quizalofop-P-ethyl <0.5 1.1 0.038 0.041 14

Sethoxydim <0.5 1.0 0.153 0.153 10

Sulfentrazone 1 1.0 0.087 0.091 70

Sulfosate 1 1.8 0.967 1.701 970

Thifensulfuron 1 1.1 0.004 0.004 3

Tribenuron-methyl 1 1.0 0.008 0.008 5

Trifluralin 2 1.0 0.818 0.818 1,454

Source: (USDA-NASS, 2007)

1- Survey States: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North 

Carolina, North Dakota, Ohio, South Dakota, Tennessee, Virginia, and Wisconsin; totaling 72.9 million planted acres.

– 27 –
Table 2-7 Common Troublesome Weeds in Treated Soybean Fields; 2006-2008

Weed Species

Total Soybean Acres Treated

2006 2007 2008

Annual Broadleaf Weeds

Buckwheat, Wild 1,167,746 855,879 1,331,675

Chickweed 1,652,712 1,259,096 1,823,638

Cocklebur, Common 23,657,980 22,389,376 23,962,063

Horseweed 2,188,359 3,159,712 3,470,274

Kochia 4,859,759 3,671,795 5,317,528

Lambsquarters, Common 21,859,614 24,459,895 28,242,972

Marestail 4,044,060 5,382,190 11,257,267

Morning glory spp. 10,711,087 11,432,904 11,011,185

Mustard, Wild 2,019,346 1,975,291 2,688,590

Nightshade, Black 1,766,649 1,277,416 1,385,751

Pigweed, Redroot 21,093,224 21,788,121 26,715,150

Pigweed, Smooth 188,160 801,569 1,322,732

Ragweed, Common 9,417,252 9,438,871 9,518,051

Ragweed, Giant 13,369,296 14,684,000 16,565,209

Sicklepod 2,024,031 1,650,086 2,535,829

Sida, Prickly 1,639,261 1,567,275 2,432,701

Smartweed, Pennsylvania 2,366,851 1,835,825 3,529,114

Sunflower, Volunteer 1,089,460 1,007,691 1,913,860

Sunflower, Wild 5,558,526 5,759,216 5,709,292

Velvetleaf 23,820,731 23,373,573 26,786,349

Waterhemp, Common 18,399,609 15,970,794 21,364,980

Waterhemp, Tall 2,301,380 2,926,358 3,826,647

Annual Grass Weeds

Barnyardgrass 4,189,156 3,967,425 3,805,391

Corn, Volunteer 2,292,705 2,088,371 3,704,330

Crabgrass 5,170,684 5,928,919 7,424,879

Cupgrass, Woolly 1,765,244 2,470,437 2,108,135

Foxtail spp. 24,409,043 18,489,746 18,446,420

Foxtail, Giant 11,817,612 17,513,493 17,804,622

Foxtail, Yellow 10,870,761 11,217,512 13,947,018

Foxtail, Green 5,629,880 7,109,316 7,610,855

Oat, Wild 1,792,389 1,478,890 2,886,300

Panicum, Fall 2,251,014 2,241,088 1,852,417

Shattercane 2,408,592 2,715,388 1,879,416

Perennial/Biennial Weeds

Dandelion 1,578,579 1,528,332 2,154,008

Johnsongrass 10,152,393 11,057,825 10,368,155

Quackgrass 2,628,187 2,570,688 2,786,633

Thistle 1,479,038 647,315 1,513,566

Thistle, Canada 4,123,437 3,584,676 4,840,383

Source: (Dow, 2010)

– 28 –
Herbicide use (as measured in terms of pounds of active ingredient applied per acre [lb. ai/A]) on 

soybeans has been relatively stable since transgenic varieties with herbicide tolerance were 

introduced in the mid-1990s, although there has been a slight increase in recent years (Brookes et 

al., 2012).

The diversity of herbicides available to US soybean growers has not decreased; rather, the diversity 

of herbicides used in US soybean production fields has gradually increased while applied 

quantities of those same herbicides (except glyphosate) have generally decreased, as indicated in 

Figure 2-3 and Table 2-5. However, total herbicide use may not be an effective metric to measure 

environmental impact, as this does not effectively permit a comparison of different herbicides, 

which may have different environmental effects, across time or across management strategies

(Fernandez-Cornejo et al., 2009).

Herbicide usage trends since the adoption of genetically engineered crops are the subject of much 

debate, with initial assessments indicating a decline in herbicide use in the early years of herbicidetolerant crop production (Carpenter et al., 2002) that some argue was then followed by an increase 

in the volume of herbicide usage as the technology spread (Benbrook, 2009). Others report a

continuing decline in herbicide use with the adoption of genetically engineered crops (FernandezCornejo and Caswell, 2006), or relative stability in the amount of herbicide active ingredients 

applied to soybeans (Brookes and Barfoot, 2010). The contradictory findings have been attributed 

to the different measurement approaches used by researchers, how different factors affecting 

pesticide use such as weather or cropping patterns were controlled for, and how the collected data 

were statistically analyzed (NRC, 2010).

Weed Resistance to Herbicides

Transgenic Crops for Herbicide Tolerance

Herbicide-tolerant soybean was introduced in 1996 to provide growers with additional options to 

improve crop safety and/or improve weed control. Soybean’s natural tolerance to herbicides that 

would normally damage the crop has been developed through conventional and mutation breeding, 

with biotechnology adding transgenic traits (Carpenter et al., 2002). Variability in the natural 

tolerance of soybean to commercially available herbicides such as 2,4-DB, metribuzin, and 

glyphosate was recognized in the 1980s (Barrentine et al., 1982). At that time, efforts to screen 

soybean germplasm for commercial levels of tolerance to glyphosate had not been successful. The 

first transgenic traits put into soybean were herbicide tolerance, with glyphosate tolerance being 

the most prevalent (Sleper and Shannon, 2003).

The adoption of herbicide-tolerant soybeans has been particularly rapid in the US, increasing from 

less than 10 percent of soybean acreage in 1996 (Lin et al., 2001) to 93 percent of soybean acreage

in 2012 (USDA-NASS, 2012b). Farmers have widely adopted herbicide-tolerant soybean because 

of lowered production costs, reduced crop injury, simplicity and flexibility in weed management, 

and because farmers can use one herbicide to control a broad spectrum of weeds instead of using 

multiple herbicides (Carpenter et al., 2002). However, using a single broad-spectrum herbicide 

intensifies selection of weed populations against the herbicide’s mode of action because repeated 

use of a single, broad-spectrum mode of action replaces use of multiple modes of action and tillage

(Vencill et al., 2012).

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2.2.3 Commercial Soybean Production and Uses

This section describes the commercial production of soybean seeds, raw and processed soybean 

commodities, organic soybeans, and specialty products.

2.2.3.1 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 variability in seed production is not 

carefully controlled, the value of a new variety or cultivar may be lost (Hartmann et al., 2011). 

Genetic purity in commercial seed production is generally regulated through a system of seed 

certification that is intended to ensure that the desired traits in the seed are maintained throughout 

all stages of cultivation.

Seed laws and certification agencies ensure that purchasers who receive certified seed can be 

assured that the seed meets established seed quality standards (Bradford, 2006). The US Federal 

Seed Act of 193915 recognizes seed certification and official certifying agencies. Implementing 

regulations further recognize land history, field isolation, and varietal purity standards. Soybean 

seed is commonly separated into three classes: Foundation, Registered, and Certified (MCIA, 

2012). Each class of seed is identified to designate the seed generation from the original breeder 

source (Hartmann et al., 2011).

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

certification programs (AOSCA, 2003). Commercially certified soybean seed must meet state and 

Federal seed standards and labeling requirements. 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. No program can ensure 100 percent 

purity of seeds, given the potential for accidents and human error. However, the existing standards 

provide a reasonable level of confidence in seed products based on the cost and feasibility of

implementing the certification programs.

2.2.3.2 Raw and Processed Soybean Commodities

Soybean plants are grown for their seed, which is processed to yield oil for a variety of uses and 

meal for human dietary products and livestock feed. Soybean is the most extensively grown oilseed 

in the world, with approximately 210 million metric tons of harvested seed produced in 2009, 

representing 56 percent of world oilseed production (Soystats, 2012a). Unprocessed soybeans have 

no human food and limited animal feed use since they contain anti-nutrient factors, such as trypsin 

inhibitors and lectins. Adequate heat processing inactivates these factors.

Approximately 85 percent of the world soybean seed supply is crushed to produce soybean meal 

and oil (Soyatech, 2012). The first modern US soybean production facility was established in 1922, 

15 7 USC 1551.

– 30 –
and soybean production for oil and animal feed increased substantively during World War II 

(Hymowitz, 1990). In the late 1940s and early 1950s, the US overtook China as the world leader in 

soybean production (Hymowitz, 1970). Most of the seed is used to supply the feed industry for 

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

portion of the world soybean seed supply is traded to other geographies, with China, the European 

Union (EU), Japan, and Mexico being the top soybean seed importers (Soystats, 2010). The 

remainder of the soybean seed produced is used as certified seed, feed, or stocks.

A bushel (27.2 kilograms) of soybeans yields about 21.8 kilograms of protein-rich meal and 

5.0 kilograms of oil (OECD, 2001a). Soybean oil makes up 94 percent of the soybean food 

ingredients consumed by humans (OECD, 2001a). The essential amino acids required for the

human diet are present in soybean proteins. Soy protein is added to a number of meat, dairy, 

bakery, and cereal products as a protein extender (OECD, 2000a).

A significant fraction of the soybean market is dedicated to production of purified oil for food use 

and industrial applications (Cahoon, 2003). The domestic food use of soybean oil is mainly in 

frying oils, salad and cooking oils, and margarines (Soystats, 2010). In 2009, these three categories 

represented approximately 85 percent of the soybean oil market in the US, with industrial uses 

consuming the remaining 15 percent (USSEC, 2006; Soystats, 2010). 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.

Soybean is also a carbon/nitrogen source in the production of yeasts via fermentation (Cahoon, 

2003). Soy-based industrial oil products have many advantages compared to petroleum oils, 

including being inherently biodegradable, having low ecotoxicity, and being derived from 

renewable resources (USSEC, 2006).

Extracting oil from soybeans also creates a highly valued solid, soybean meal, which is used for 

animal feed in all livestock sectors (swine, beef, poultry, dairy, and fish) and human food protein 

(CAST, 2009). Tofu, soy milk, soy sauce, miso, meat substitutes, protein powder, soynuts, soy 

sprouts, baked or roasted soybeans, and soy flour are the soy-based products present in the human 

diet. Processed soybeans are the largest source of protein for livestock in the world (USDA-ERS, 

2010a), accounting for nearly 69 percent of world protein meal supplies (Soystats, 2010). Globally, 

most soybean meal, 97 percent, is used in animal feed, with 46 percent going to poultry, 32 percent 

to swine, and 9 percent each going to dairy and beef cattle feed, respectively. About 2 percent is 

used in pet food (OECD, 2001a).

Although honeybees have been reported to forage for nectar in soybean fields (Erickson, 1975), 

soybeans are not reported to be commercial honey sources (Morse and Calderone, 2000).

2.2.3.3 Organic Soybean Production

In the US, 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. The NOP was 

– 31 –
established by the Organic Foods Production Act of 199016 and implementing USDA regulations

(USDA, 2012).

Organic production operators must develop and maintain an organic system plan approved by an 

accredited certifying agent (USDA, 2012).

17 The plan describes how the operation will achieve and 

document compliance with the NOP’s National Organic Standards. Before an operation is certified 

to sell organic soybeans the cropland must be managed organically for a minimum of 36 months

(USDA, 2012)

18. The NOP requires organic farming operations to have distinct, defined 

boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining 

land that is not under organic management (USDA, 2012)

19. The NOP regulations preclude the use 

of excluded methods in crop production. Excluded methods are 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 traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, 

or tissue culture.”

Use of synthetic insecticides, fertilizers, and transgenic crops is excluded from certified organic 

production systems. Natural products are allowed. Since organic certification is process-based, the 

presence of a detectable residue of a product of excluded methods (including genetically modified 

organism residues; e.g., transgenic soybean) does not by itself constitute a violation of the NOP 

regulations (USDA-AMS, 2011). The NOP regulations do not specify an acceptable threshold 

level for the adventitious presence of genetically engineered materials in an organic-labeled 

product. The unintentional presence of the products of excluded methods will not affect the status 

of an organic product or operation when the operation has not used the excluded methods and has 

taken reasonable steps to avoid contact with the products of excluded methods as detailed in their 

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

To prevent gene flow between conventional crops and to produce genetically pure seed, different 

types of crops should be separated from each other by an adequate isolation distance (Carpenter et 

al., 2002). Common practices organic growers may use to prevent gene flow from genetically 

engineered organisms include planting only organic seed, planting earlier or later than neighboring 

farmers who may be using transgenic crops so that the two 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 (Sundstrom et al., 2002; NCAT, 

2003; Bradford, 2006; Baier, 2008). Isolation distances vary between crops based on the type of 

pollination. Isolation distances for soybean are usually not required because the crop is

16 Title 21 of Public Law 101-624, the Food, Agriculture, Conservation, and Trade Act of 1990, as amended.

17 Section 201

18 Section 205.202(b)

19 Section 205.202(c)

– 32 –
predominantly self-pollinated; however, as described in Section 2.1, insect-mediated outcrossing 

may occur over short distances in some cultivars if the different cultivars have synchronized 

flowering.

Organic soybean production practices include crop rotation, use of cover crops, green and animal 

manures, application of rock minerals such as lime, other soil additives, mechanical weed control, 

biological control of pests, and disease control primarily through management practices (Kuepper, 

2003; Heatherly et al., 2009; USDA-AMS, 2011). Based on 2006 ARMS data, more than 

90 percent of organic soybean producers planted in standard width rows, as compared to 

60 percent of other soybean producers (McBride and Greene, 2008). The standard row spacing 

may be utilized by organic farmers to facilitate mechanical weed control that would be hindered by 

narrow row spacing where weed control is accomplished by chemical means that are prohibited in 

organic systems. Further, organic soybean operations rotated crops more often, and 40 percent of 

the farmers incorporated a 1-year fallow into their organic soybean rotation.

Weed control in organic systems is accomplished with delayed seeding to avoid spring weeds,

applying fertilizer to growing plants to outcompete weeds, increasing seeding rates, sowing cover 

crops, rotating crops, intercropping, flame weeding, hand weeding, and tilling (Kuepper, 2003; 

Heatherly et al., 2009). Organic crop production historically employed mulch and ridge tillage 

practices (NCAT, 2003); no-till practices may be unsustainable in some long-term organic systems 

because of increasingly poor weed control. Field evaluations of several tillage methods in organic

systems conducted over 9 years found that factors contributing to poor weed control included 

uneven seeding beds produced by chisel-tilling in a cover crop and animal manure, variable ground 

cover occurring in mowed cover crop residue, insufficient disruption of weed roots by sweep-type 

cultivators, and the short grain crop rotation system used was unsuitable for maintaining a low 

weed seedbank (Teasdale et al., 2007).

Pest control in organic systems is accomplished with application of natural pesticides, integrated 

pest management techniques such as introduction of beneficial organisms (predator and parasitic 

organisms), and some of the practices described for conventional weed control (crop rotation, 

intercropping, and use of cover crops) (NCAT, 2003). Diseases are primarily controlled in organic 

systems by planting disease-resistant varieties, using management practices that promote healthy 

soil, rotating crops, diligently removing diseased plant material, and managing plant canopy. When 

physical, mechanical, or biological controls are not sufficient for controlling weeds, pests, or 

disease, only a biological, botanical, or synthetic substance approved on the national list may be 

used (USDA-AMS, 2011).

Organic soybeans represent between 0.17 and 0.22 percent of US soybean production (USDAERS, 2010c). In 2011, certified organic soybeans were harvested from 96,080 acres in 28 states, 

resulting in 2.9 million bushels of soybeans (USDA-NASS, 2012a). Table 2-8 indicates the 

acreage of organic soybean produced in each state.

Organic soybean field yields are lower or equal to conventional soybean yields (Cavigelli and 

Conklin, undated). Organic soybean producers had an average yield in 2006 of 31 bushels per acre, 

as compared to 47 bushels per acre for conventional soybean yield (McBride and Greene, 2008). 

Lower yields are generally attributed to competition with weeds in organic systems.

– 33 –
In 2006, the total estimated additional costs for producing organic relative to conventional 

soybeans were $0.82 per bushel for operating costs alone, $2.61 per bushel for operating and 

capital costs together (including transition costs), and $6.20 per bushel for total economic costs 

(McBride and Greene, 2008).

Table 2-8 US Certified Soybean Acreage by State, 2011

State Acres State Acres

Arkansas (D) Missouri 5,505

Delaware (D) Nebraska 6,211

Georgia (D) New Jersey (D)

Idaho (D) New York 8,621

Illinois 6,633 North Carolina (D)

Indiana 945 North Dakota 3,288

Iowa 12,659 Ohio 5,634

Kansas 1,311 Pennsylvania 1,280

Kentucky (D) South Dakota 3,962

Louisiana (D) Tennessee (D)

Maine (D) Texas (D)

Maryland 1,090 Vermont 527

Michigan 11,699 Virginia 150

Minnesota 16,150 Wisconsin 7,622

Source: (USDA-NASS, 2012a)

(D) = Withheld to avoid disclosing data for individual operations. Total area in this table is therefore 84,666 acres, less than the US total of 96,080 acres.

2.2.3.4 Specialty Production Systems

Specialty production refers to specialized agronomic practices as compared to those described in 

Section 2.2.2, Agronomic Practices, and unique soybean commodities as compared to those 

described in Section 2.2.3.2, Raw and Processed Soybean Commodities. Specialty soybean 

varieties are produced on approximately 12 percent of the US soybean acreage.

The Identity Preservation (IDP) production and distribution systems accommodate differences 

between commodity and specialty soybean. 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 et al., 2004). The specialty soybean 

market produces soybeans that have specific physical or chemical characteristics to meet specific 

buyer requirements. A separate specialty soybean production channel has developed for the 

specialty soybean product that involves much smaller volumes than commodity soybean. Specialty 

soybeans can be grouped into several broad, but overlapping, categories, as listed below.

• Altered seed composition

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o Low saturated fat

o High sucrose

o High oleic fatty acid

o Low linolenic fatty acid

o High protein 

• Unique physical characteristics or uses

o Clear hilum

o Tofu

o Natto

o Soy milk

The categories are not exclusive. Soybeans of all specialty categories are often derived from 

varieties produced according to certified seed production practices, as described in Section 2.2.3.1, 

Seed Production.

Specialty soybeans often earn premiums (Pritchett et al., 2002). The greatest premium received by 

producers is for tofu soybeans, but these have higher production costs related to seed cost, 

technology fees, and transportation costs. Seed soybeans have additional costs related to more 

intensive production/management requirements and herbicide costs, although the seed technology 

fees and additional transportation costs remain important factors.

Product differentiation and market segmentation in the specialty soybean industry includes 

mechanisms to keep track of the grain (traceability) for IDP and quality assurance processes 

(e.g., ISO9001-2000 certification), as well as contracts between growers and buyers that specify 

delivery agreements (Sundstrom et al., 2002). Systems used by specialty soybean growers and end 

users to maintain identity of the production include:

• Contracts – written agreements detailing responsibilities and duties of both parties including 

premiums for reaching goals and penalties for failing to attain specifications.

• Tracking and Traceability Systems – correct labeling of all products (planting seeds and 

harvested material) and testing procedures for identifying and detecting acceptability of 

materials.

• Quality Assurance Processes – oversight on handling procedures, testing planting seeds, 

and testing harvested materials to determine acceptability of use and product requirements, 

and assuring testing procedures are appropriate.

• Closed-Loop Systems – the end-user supplies the planting seeds and guarantees to purchase 

final products. This may also require that the end-user conduct intermediate procedures such 

as planting, providing oversight during the growing season, harvesting, and transportation to 

processing plant.

• Identity Preservation Systems – using systems of identity preservation that have been 

shown to be successful in the past such as the seed certification systems conducted by 

members of the AOSCA. To maintain the purity of the soybean product, this production 

– 35 –
system is based on controlling, tracking and documenting each step from seed production to 

end use (processing plants) (AOSCA, 2003).

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., edamame or vegetable soybean) (Cui et al., 2004). Weed control is extremely important for 

specialty soybean to maintain a high yield potential.

2.3 Physical Environment

Soil, water, and air affect, and are affected by, soybean agriculture. This section describes water 

quality, soil characteristics, and air quality impacted by soybean agriculture. Climatic conditions, 

in the context of potential climate change, are also discussed.

2.3.1 Soil

Soil consists of solids (minerals and organic matter), liquids, and gases. This body of inorganic and 

organic matter is home to a wide variety of fungi, bacteria, and arthropods, and is the growth 

medium for terrestrial plant life (USDA-NRCS, 2004). Soil is characterized by its layers that can 

be distinguished from the initial parent material due to additions, losses, transfers, and 

transformations of energy and matter (USDA-NRCS, 1999b). It is further distinguished by its 

ability to support rooted plants in a natural environment. Soil plays a key role in determining the 

capacity of a site for biomass vigor and production in terms of physical support, air, water, 

temperature moderation, protection from toxins, and nutrient availability. Soils also determine a 

site’s susceptibility to erosion by wind and water, and flood attenuation capacity. Soil properties 

change over time: temperature, pH, soluble salts, amount of organic matter, the carbon-nitrogen 

ratio, and the numbers of microorganisms and soil fauna all vary seasonally, as well as over 

extended periods of time (USDA-NRCS, 1999b). Soil texture and organic matter levels directly 

influence its shear strength, nutrient holding capacity, and permeability. 

Soil taxonomy was established by scientists to classify soils according to the relationship between 

soils and the factors responsible for their character (USDA-NRCS, 1999b). Soils are differentiated 

based on characteristics such as particle size, texture, and color, and classified taxonomically into 

soil orders based on observable properties such as organic matter content and degree of soil profile 

development (USDA-NRCS, 2010). From an ecological perspective, organic matter is probably the 

most vital component in maintaining quality soil; it is instrumental in maintaining soil stability and 

structure, reduces the potential for erosion, provides energy for microorganisms, improves 

infiltration and water holding capacity, and is important in nutrient cycling, cation exchange 

capacity20, and the breakdown of pesticides (USDA-NRCS, 1996).

20 Soil cation exchange capacity is the ability of soil anions (negatively charged clay, organic matter and inorganic 

minerals such as phosphate, sulfate, and nitrate) to adsorb and store soil cation nutrients (positively charged ions 

such as potassium, calcium, and ammonium).

– 36 –
The interactions between the below-ground community of microorganisms and arthropods, plant root 

structure, and organic residues in the soil are central to soil ecological processes including 

decomposing organic material, subsequent nutrient cycling and release, and maintaining soil 

structure and composition. Cultivation directly impacts these biological attributes. Agronomic 

practices such as conventional tillage and mechanized harvesting machinery may disturb and expose 

the top soil surface layer, leaving the land prone to degradation or, conversely, improving soil health. 

Soil degradation can lead to a decline in water quality and contribute to the greenhouse effect by 

releasing sequestered carbon dioxide (CO2) (Lal and Bruce, 1999). A decline in soil quality and soil 

resilience enhances the greenhouse effect through emissions of radiatively active gases (CO2 and

nitrous oxide, N2O). Land that is prone to degradation is also more likely to adversely impact water 

quality and communities of organisms dependent on those water resources. While practices such as 

tillage, fertilization, pesticide application, and other management tools can improve soil health, they 

can also cause substantial damage if not properly used. Inappropriate agricultural practices can lead 

to increased erosion, soil compaction, degradation of soil structure, nutrient loss, increased salinity, 

change in pH, and reduced biological activity (USDA-NRCS, 2001).

Soybeans are grown in managed agricultural fields and are best suited to fertile, well-drained 

medium-textured loam soils, yet can be produced in a wide range of soil types (Berglund and 

Helms, 2003). Soybeans need a variety of macronutrients (such as nitrogen, phosphorus, 

potassium, calcium, magnesium, and sulfur) at various levels (NSRL, undated). They also require 

smaller amounts of micronutrients such as iron, zinc, copper, boron, manganese, molybdenum, 

cobalt, and chlorine. These micronutrients may be deficient in poor, weathered soils, sandy soils, 

alkaline soils, or soils excessively high in organic matter. As with proper nutrient levels, soil pH is 

critical for soybean development. Soybeans grow best in soil that is slightly acidic (pH 5.8 to 7.0); 

more alkaline soils (pH 7.3 or greater) negatively affect yield (Cox et al., 2003). Similarly, soils 

that are high in clay and low in humus may impede plant emergence and development (NSRL, 

undated). Soils with some clay content may retain moisture during periods of low precipitation

than those with no clay content (Cox et al., 2003).

Conservation tillage methods (as described in Section 2.2.2.1, Cropping Practices) leave a crop 

mulch on the ground to provide a protective cover to the soil between seasons and improve soil 

fertility by maintaining nutrient-rich organic matter on the field. As conservation practices are 

adopted, soil organic matter increases help bind soil nutrients and significantly reduce the loss of 

cropland soil from runoff, erosion, and leaching over time (USDA-NRCS, 2006a; USDA-NRCS, 

2006b). Organic matter builds up in the soil, absorbing CO2 and helping to reduce a significant 

amount of greenhouse gas.

One of the most effective soil conservation methods to reduce wind and water erosion is through 

management of crop residue, which also benefits air and water quality and wildlife (USDA-NRCS, 

2006a). Residue management that uses intensive tillage and leaves low amounts of crop residue on 

the surface results in greater losses of soil organic matter as compared to conservation tillage 

methods. Intensive tillage turns the soil over and buries the majority of the residue, stimulating

microbial activity and increasing the rate of residue breakdown (USDA-NRCS, 1996). The residues 

left after conservation tillage increase organic matter and improve infiltration, soil stability and 

structure, and soil microorganism habitat (Fawcett and Caruana, 2001; USDA-NRCS, 2005).

– 37 –
The residue left over from conservation tillage practices increases organic matter in the top 

3 inches of the soil and protects the surface from erosion while maintaining water-conducting 

pores. Soil aggregates in conservation tillage systems are more stable than those of conventional

tillage due to the products of organic matter decomposition and the presence of soil bacteria and 

fungal hyphae (filamentous structures that composes the main growth) that bind aggregates and 

soil particles together (USDA-NRCS, 1996). Although soil erosion rates are dependent on

numerous local conditions such as soil texture and crop, a comparison of 39 studies contrasting

conventional and no-till practices concluded that, on average, no-till practices reduce erosion

488 times over conventional tillage (Montgomery, 2007). This reduction is enough to balance soil

production with losses from erosion. From 1982 through 2003, erosion on US cropland dropped 

from 3.1 billion tons per year to 1.7 billion tons per year (USDA-NRCS, 2006a). This can partially 

be attributed to the increased effectiveness of weed control through the use of herbicides and the 

corresponding reduction in the need for mechanical weed control (Carpenter et al., 2002). Another 

factor is the Conservation Reserve Program described in Section 2.2.2.1, which provides financial 

incentives to farmers to use conservation tillage techniques or set aside land from agricultural use

(USDA-FSA, 1999). Conservation tillage also minimizes soil compaction due to the reduced 

number of tillage trips.

While conservation tillage does have several benefits for soil health, some management concerns 

are associated with its use in certain circumstances. Under no-till practices, soil compaction may 

become a problem as tillage is useful for breaking up compacted areas (USDA-NRCS, 1996). 

Likewise, not all soils (such as wet and heavy clay soils) are suited for no-till. No-till practices may

lead to increased pest occurrences that conventional tillage is better suited to managing (NRC, 

2010) as described in Section 2.2.2.5, Management of Disease and Non-Insect Pests.

Other methods to improve soil quality include:

• Careful management of fertilizers and pesticides;

• Use of cover crops to increase plant diversity and limit the time soil is exposed to wind and 

rain; and

• Increase landscape diversity with buffer strips, contour strips, wind breaks, crop rotations, and 

varying tillage practices (USDA-NRCS, 2006a).

There are a multitude of organisms associated with soils, ranging from microorganisms to larger

invertebrates such as worms and insects. The microorganisms that make up the soil community

include bacteria, fungi, protozoa, and nematodes, as discussed in Section 2.4.3, Soil 

Microorganisms. These organisms are responsible for a wide range of activities that impact soil 

health and plant growth. Pesticide (including herbicide) use has the potential to affect soil quality 

due to potential impacts to the soil microbial community. The length of time that herbicides persist 

in soil is dependent on the concentration and rate of degradation by biotic and abiotic processes

(Carpenter et al., 2002). Persistence is measured by the half-life or dissipation time, which equates 

to the length of time needed for the herbicide to degrade to half of its original concentration. 

Herbicide persistence in soil for mesotrione, isoxaflutole, and glufosinate (the three herbicides of 

which SYHT0H2 soybean is tolerant) is discussed in detail in the appendices.

– 38 –
2.3.2 Water Quality

The primary cause of agricultural nonpoint source (NPS) pollution is increased sedimentation from 

soil erosion, which can introduce sediments, manure, fertilizers, and pesticides to nearby lakes and 

streams (USEPA, 2005). Water quality risks from herbicide use are assessed by the EPA during the 

herbicide registration (and re-registration review) process and are addressed, as warranted, through 

EPA requirements such as application methodology and buffer zones between fields and water 

bodies, as well as monitoring for herbicide residues in surface and ground water. There are no federal 

water quality standards for the enzymes present in transgenic herbicide-tolerant plant varieties.

Additionally, add the following to the reference cited above:

Although meteorological (precipitation, temperature), morphological (land use, soil type), and 

environmental fate drivers affect water quality, anthropogenic practices (product use and 

management) are the most relevant, as these are generally under direct grower control on a soybean 

farm (Ramanarayanan et al., 2005). Certain agronomic practices, including conservation tillage and 

reduced fertilizer or pesticide application rates, may reduce adverse impacts. The EPA 

recommends several Best Management Practices for protecting water quality from agricultural 

NPS pollution (USEPA, 2008a):

• Conservation Tillage - leaving crop residue (plant materials from past harvests) on the soil 

surface reduces runoff and soil erosion, conserves soil moisture, helps keep nutrients and 

insecticides on the field, and improves soil, water, and air quality;

• Crop Nutrient Management - fully managing and accounting for all nutrient inputs helps 

ensure that nutrients are available to meet crop needs while reducing nutrient movement off

of fields. It also helps prevent excessive buildup in soils and helps protect air quality;

• Pest Management - varied methods for keeping insects, weeds, disease, and other pests 

below economically harmful levels while protecting soil, water, and air quality; and

• Conservation Buffers - from simple grassed waterways to riparian areas, buffers provide an 

additional barrier of protection by capturing potential pollutants that might otherwise move 

into surface waters.

Conservation tillage (including no-till practices) has been shown to minimize surface water runoff 

and soil erosion. As discussed in Section 2.3.1, Soil, reduced tillage agricultural practices result in 

improved soil quality having high organic material that binds nutrients within the soil. An 

increased amount of plant residue on the soil surface reduces the effects of pesticide usage on 

water resources by forming a physical barrier to erosion and runoff, allowing more time for 

absorption into the soil, and slowing down soil moisture evaporation (Locke et al., 2008).

Improving soil quality increases soil organic matter that promotes nutrient, pesticide, and herbicide

binding to soil and prevents their loss to surface waters and groundwater from runoff, erosion, and 

leaching. Farmers planting genetically engineered herbicide-tolerant soybean varieties are more 

likely to use conservation tillage over conventional agricultural practices (Givens et al., 2009). The

shift to genetically engineered varieties has resulted in reduced surface water run-off and soil

erosion (Locke et al., 2008).

– 39 –
2.3.3 Air Quality

Agriculture is an important market sector impacting air quality. Agricultural air emission sources 

include: smoke from agricultural burning, vehicle exhaust from equipment used in tillage and 

harvest, soil particulates (dust) from tillage, pesticide drift from spraying, and N2O emissions from 

the use of nitrogen fertilizer (Aneja et al., 2009). Certain pesticides may volatilize after application 

to soil or plant surfaces and may also move as constituents of dust in wind eroded soils (Vogel et 

al., 2008). Agricultural air pollution also contributes to odor. After deposition of reactive nitrogen 

in waterways, eutrophication and acidification can result and affect biodiversity. Air quality can be 

improved by using conservation tillage methods in place of conventional (intensive) tillage as less 

dust is produced and fewer pollutants are emitted from farm equipment.

2.3.4 Climate

Agriculture is responsible for an estimated 6.3 percent of all human-induced greenhouse gas (GHG) 

emissions in the US (USEPA, 2012a), the second-highest source. Agricultural soil management 

practices, including nitrogen-based fertilizer application and cropping practices, are the largest source 

of N2O emissions in the US, accounting for 67.9 percent of the total N2O emissions attributable to 

agricultural land uses (USEPA, 2012a). Agriculture sources of methane (CH4) emissions are 

primarily associated with enteric emissions of gas from cattle and manure management, and are

responsible for 29 percent of CH4 emissions from anthropogenic activities in the US (USEPA, 

2012a). CO2 is also a significant GHG associated with particular classes of crops planted, geographic 

location and soil types, and energy consumption (Cole et al., 1997).

GHGs may be 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 GHGs (Cole et al., 1997). For example, 

emissions of N2O, 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 (USDS, 2010). These agricultural practices can influence the decomposition 

of carbon-containing organic matter sequestered in soil, resulting in CO2 loss to the atmosphere.

In agricultural soils, mineral and organic soils sequester approximately six times as much carbon as 

is emitted from these soils through liming and urea fertilization (USEPA, 2012a). The mineral soil 

carbon sequestration is largely due to the conversion of cropland to permanent pastures and hay

production, a reduction in summer fallow areas in semi-arid areas, an increase in the adoption of 

conservation tillage practices, and an increase in the amounts of organic fertilizers (i.e., manure 

and sewage sludge) applied to agriculture lands. EPA has identified regional differences in GHG

emissions associated with agricultural practices on different soil types (USEPA, 2012a). Mineral 

soils contain from 1 to 6 percent organic carbon by weight; conversion of such soils from their native 

state to agricultural uses can cause as much as 50 percent of the natural organic carbon to decompose 

and be released to the atmosphere. In contrast to mineral soils, organic soils may contain as much as 

20 percent carbon by weight. When such soils are prepared for agricultural use, they are aerated, 

accelerating decomposition and release of CO2 to the atmosphere.

– 40 –
Tillage contributes to the release of GHGs from soil because of the loss of CO2 to the atmosphere 

from the exposure and oxidation of soil organic matter (Baker et al., 2005). Reduced tillage can 

limit the loss of CO2 to the atmosphere by preventing exposure and oxidation of soil organic matter 

(Baker et al., 2005; CAST, 2009). In general, conservation tillage strategies are associated with 

more stable and increased carbon sequestration due to a net reduction in CO2 emissions (Lal and 

Bruce, 1999; West and Marland, 2002). Recent literature, however, suggests that the relationship 

between conservation tillage and increased carbon sequestration requires more study, as soil depth 

level and seasonal sampling bias may inadvertently affect measurements (Potter et al., 1998; Baker 

et al., 2007). Increased N2O emissions as a result of conservation tillage strategies may offset any 

gains achieved through increased carbon sequestration (Gregorich et al., 2005). A broad 

generalization regarding the impact of tillage strategy and N2O emissions is difficult to make, as 

numerous factors influence soil nitrification cycles, including geographic location, soil structure, 

moisture, and farm-level management practices (Grandy et al., 2006; Gregorich et al., 2006; 

Rochette et al., 2008).

The impacts of genetically engineered crop varieties on climate change are dependent on many 

variables including cropping systems, production practices, geographic distribution of activities, 

and individual grower decisions. Agriculture influences emissions that may contribute to climate 

change, and climate change, in turn, potentially affects agriculture through shifts in precipitation 

patterns and temperature ranges. The production of genetically engineered soybeans is expected to 

result in lower GHG emissions because fuel use would be reduced due to less frequent herbicide 

applications and soil cultivation (Brookes and Barfoot, 2010). Most studies of corn, rice, sorghum, 

soybean, wheat, common forages, cotton, some fruits, and irrigated grains project likely climaterelated yield increases of 5 to 20 percent (Field et al., 2007). However, this positive impact would 

not be observed evenly across all regions as certain areas of the US are expected to be negatively 

impacted by substantially reduced water resources (i.e., increased drought). In addition, the current 

range of weeds and pests of agriculture is expected to change in response to climate change

(USGCRP, 2009).

2.4 Biological Resources

The biological resources described in this section include animals, plants, soil microorganisms, 

biodiversity, and soybean gene movement. Threatened and endangered species are discussed in 

Chapter 5.

2.4.1 Animal Communities

Soybean fields are host to many animal species. During the spring and summer months, soybean 

fields provide browse for rabbits, deer, rodents, other mammals, and birds such as upland 

gamebirds. Fields also provide a forage base for insects (Palmer et al., undated). During the winter 

months, leftover and unharvested soybeans provide a food source for wildlife; however, soybeans 

are poorly suited for meeting nutrient needs of wildlife, such as waterfowl, that require a highenergy diet (Krapu et al., 2004b).

– 41 –
As discussed in Section 2.2.2.1, Cropping Practices, farmers that have shifted from conventional 

agricultural practices to conservation tillage and no-till practices have also been more inclined to

plant genetically engineered herbicide-tolerant soybean varieties than farmers retaining 

conventional practices (Givens et al., 2009). The increased use of conservation tillage practices has 

benefitted wildlife through improved water quality, availability of waste grain, retention of cover in 

fields, and increased populations of invertebrates (Sharpe, 2010). Conservation tillage practices 

that leave greater amounts of crop residue serve to increase the diversity and density of birds and 

mammals (USDA-NRCS, 1999a). Increased residue also provides habitat for insects and other

arthropods, increasing this food source for insect predators. Insects are important during the spring 

and summer brood rearing season for many upland game birds and other birds, as they provide a 

protein-rich diet to fast growing young, as well as a nutrient-rich diet for migratory birds (USDANRCS, 2003).

Insects and other invertebrates can be beneficial to soybean production, providing biological

services such as nutrient cycling and preying on plant pests. Although soybean is typically 

cleistogamous and not insect-pollinated, some varieties may be chasmogamous and insectmediated pollination has been reported (Erickson, 1975; Ahrent and Caviness, 1994). Soybean 

cultivars vary in their rate of nectar secretion and some varieties have been reported to be attractive 

to honeybees (Ahrent and Caviness, 1994). Conversely, there are many insects and invertebrates 

that are detrimental to soybean crops (Whitworth et al., 2012; Palmer et al., undated), including:

• Bean leaf beetle (Cerotoma trifurcata)

• Beet armyworm (Spodoptera exigua)

• Blister beetle (Epicauta spp.)

• Corn earworm (Helicoverpa zea)

• Grasshopper (Acrididae spp.)

• Green cloverworm (Hypena scabra)

• Seed corn beetle (Stenolophus lecontei)

• Seed corn maggot (Delia platura)

• Soybean aphid (Aphis glycines)

• Soybean looper (Pseudoplusia includens)

• Soybean stem borer (Dectes texanus)

• Spider mites (Tetranychus urticae)

• Stink bug (green [Acrosternum hiliare] and brown [Euschistus spp.])

• Velvetbean caterpillar (Anticarsia gemmatalis)

As described in Section 2.2.2.4, Management of Insects, insects are considered less problematic 

than weeds in US soybean production; however, insect injury can impact yield, plant maturity, and 

seed quality. Consequently, insect pests are sometimes managed during the growth and 

development of soybean to enhance soybean yield (Aref and Pike, 1998).

2.4.2 Plant Communities

Soybean fields are typically bordered by other agricultural fields, pastures, woodlands, or

grasslands; natural plant communities adjacent to fields may be important to biodiversity. From an 

agronomic perspective, the most important members of a surrounding plant community are those 

– 42 –
that can behave as weeds when they have invaded fields, as discussed in Section 2.2.2.6, 

Management of Weeds. Soybean agronomic performance can be reduced by weed competition for 

water, nutrients, and light. Adjacent natural or native plant communities that do not behave as 

weeds are important from an ecological perspective but not agronomically.

Plants are classified as annuals, biennials, or perennials. An annual is a plant that completes its 

lifecycle in 1 year or less and reproduces only by seed. Biennials are plants that complete their life 

cycles in 2 years. Perennials are plants that live for more than 2 years. Plants are also classified as 

broadleaf (dicots) or grass (monocots). Plants can reproduce by seeds, rhizomes (underground 

creeping stems), or other underground parts. Many plant species occur as weeds in fields.

Weed Resistance to Herbicides

Herbicide resistance is generally defined by the Weed Science Society of America (WSSA)21 as 

“the inherited ability of a plant to survive and reproduce following exposure to a dose of herbicide 

normally lethal to the wild type. In a plant, resistance may be naturally occurring or induced by 

such techniques as genetic engineering or selection of variants produced by tissue culture or 

mutagenesis” (WSSA, 2013). Increasing the intensity of herbicide use (frequency and number of 

acres treated) increases the probability of selecting an herbicide-resistant plant (Boerboom and 

Owen, 2006) from a population of a weed species. WSSA defines herbicide tolerance as “the 

inherent ability of a species to survive and reproduce after herbicide treatment. This implies that 

there was no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant” 

(WSSA, 2013). A number of crops and weeds exhibit natural tolerance to some herbicides by 

preventing their absorption and/or translocation, or by rapidly metabolizing the herbicide to a nontoxic form (Loux et al., 2008). Natural herbicide tolerance has been observed in weed species such 

as waterhemp, common cocklebur, Powell amaranth, ragweed (common and giant), and kochia 

(Carpenter et al., 2002). 

Herbicides do not cause the mutations that result in weeds developing resistance. Rather, an 

extremely rare genetic trait that allows a weed to survive any given herbicide may exist in the natural 

population. That gene is more likely to be found and increase in occurrence when one herbicide is 

used frequently. Repeated use of that herbicide will expose the weed population to selection pressure 

that may lead to an increase in the number of surviving resistant individuals in the population

(HRAC, 2011). In other words, plants susceptible to the applied herbicide will die or have decreased 

reproduction; those few having some type of natural resistance will survive and reproduce. Resistant 

weeds that initially appear as isolated plants or patches in a field can quickly spread to dominate 

the population and the soil seed bank (Vencill et al., 2012).

21 www.wssa.net

– 43 –
The reproductive biology of the particular weed species appears to be a factor contributing to the 

spread of resistant biotypes. For example, resistant biotypes of marestail (Conyza canadensis), 

which produces a large number of wind dispersed seeds contributing to a rapid distribution, have

been found in many states in the Northeast, Midwest, and South. Other species such as common 

ragweed (Ambrosia artemisiifolia) 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 only 

seven sites in the Midwest, North and South compared to 24 sites for C. canadensis (Heap, 2013a).

The risk of weeds developing resistance to herbicides and the potential impact of resistance on the 

usefulness of an herbicide varies greatly across different modes of action and depends on a 

combination of factors including selection pressure, herbicide soil residual activity, herbicide 

chemistry, the rate of seed production, and the level of genetic variation in plants. Another major 

factor contributing to the development of herbicide-resistant weeds is poor weed control 

management practices by the growers. These include application of herbicides at rates below those 

indicated on the EPA-approved label for the weed species and reliance on a single herbicide for weed 

control without the use of other cultural control methods (i.e., pre-plant and in-crop tillage) (Peterson 

et al., 2007). Weed management programs that integrate the use of herbicides with different modes of 

action and short residual activity times in soil reduce selection pressure (Prather et al., 2000). 

Growers have been successfully managing herbicide-resistant weeds for decades by using alternative 

herbicides and cultural methods such as tillage or crop rotation (and often necessarily incorporating 

rotation of herbicide modes of action). 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.

Globally, 397 weed biotypes have developed resistance to 21 herbicide modes of action (Heap, 

2013a). In the US, 142 weed biotypes have developed resistance to herbicides. Some populations 

of certain weed species have developed resistance to multiple herbicide classes (Boerboom and 

Owen, 2006). For example, some tall waterhemp plants are known to be resistant to up to four 

herbicide modes of action (Tranel, 2010; McMullan and Green, 2011). Most herbicides affect a 

single specific site of action, and that site is usually under the control of a single gene, or at most a 

few genes. Annual weeds are more likely to evolve resistance because they typically produce 

abundant seeds and have more genetic diversity than species that reproduce vegetatively.

For many years, growers were able to effectively control or suppress virtually all weeds in soybean 

with glyphosate alone. However, a number of weed species have developed resistance to 

glyphosate, and the number of acres infested with resistant biotypes has been increasing. To date, 

24 weed species resistant to glyphosate have been identified globally, 14 of which are found in the 

US (Heap, 2013c). Glyphosate-resistant weed biotypes in US soybean fields vary by state

(Figure 2-4). Each of these species is generally controlled by mesotrione, isoxaflutole, or 

glufosinate except hairy fleabane, Italian ryegrass, and rigid ryegrass (Syngenta, 2012d), which are 

not, however, typically problematic in soybean fields (see Table 2-7, Common Troublesome Weeds 

in Treated Soybean Fields, 2006-2008). Other herbicides are available to control these species, and 

could be appropriately used in an integrated weed management program.

– 44 –
Figure 2-4 Glyphosate-Resistant Weeds in US Soybean Fields

Source: (Heap, 2013d)

Note that presence of a population is unrelated to prevalence. 

* indicates at least one population in that state possesses resistance to glyphosate and another herbicide. 

**indicates at least one population in that state possesses resistance to glyphosate and two other herbicides.

All of the weed species that are resistant to glyphosate are fully or partially controlled by one or 

more of the herbicides to which SYHT0H2 soybean is tolerant, as discussed in the appendices. 

However, certain biotypes of three weed species have developed resistance to HPPD-inhibiting 

herbicides (including mesotrione and/or isoxaflutole) or glufosinate when applied to the weed postemergence:

• Certain common waterhemp (Amaranthus tuberculatus (syn. rudis)) populations have 

evolved resistance to post emergence applications of HPPD-inhibiting herbicides including 

mesotrione and isoxaflutole in US fields where full rates of an HPPD herbicide have been 

used in multiple years during seed corn production (Heap, 2013b); 

• Two Palmer amaranth (Amaranthus palmeri) populations have recently been reported to be 

resistant to HPPD inhibitors (Heap, 2013b); and

• Certain Italian ryegrass (Lolium multiflorum) populations in US fields have been shown to be 

resistant to glufosinate (Heap, 2013c).

The conditions leading to populations of these weeds evolving resistance to these herbicides occurred 

during a time of less diversity in herbicide usage and cultural practices. In an Illinois biotype of 

common waterhemp found to be resistant in 2009, for example, an absence of crop rotation and 

herbicide rotation, and failure to use mixed products containing multiple modes of herbicidal action 

in a corn seed production field contributed to the development of HPPD-inhibitor resistance 

– 45 –
(Hausman et al., 2011). Crop management practices in seed corn production fields are not 

representative of fields in which corn hybrids or soybean varieties are grown commercially.

Modeling predicts that herbicide-resistant weeds can evolve after only 4 or 5 years of continuous 

herbicide use (Neve et al., 2011a; Neve et al., 2011b). This prediction is consistent with 

observations based on actual glyphosate use. Implementing additional weed management 

strategies, such as diversity of herbicide modes of action providing full, effective season-long weed 

control, could delay or mitigate herbicide resistance in Palmer amaranth, for example, for at least 

20 years (Neve et al., 2011b).

Plant communities adjacent to agricultural fields may be affected by spray drift or volatilization of 

herbicides applied to the nearby crops. Spray drift and volatilization are managed by adherence to

the application requirements stated on EPA-approved herbicide labels.

2.4.3 Soil Microorganisms

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

toxin removal, nutrient cycling, and most biochemical soil processes (Garbeva et al., 2004). The 

main factors affecting microbial population size and diversity include soil type (texture, structure, 

organic matter, aggregate stability, pH, and nutrient content), plant type (as 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), as described in 

Section 2.3.1, Soil. 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 different from the microbial community in bulk soil 

(Garbeva et al., 2004).

Decomposers (such as bacteria, actinomycetes [filamentous bacteria], and saprophytic fungi)

degrade plant and animal remains, organic materials, and some pesticides (USDA-NRCS, 2004). 

Other organisms (such as protozoa, mites, and nematodes) consume the decomposer microbes and 

release macro- and micronutrients, making them available for plant usage. Mutualists (mycorrhizal 

fungi, nitrogen-fixing bacteria, and some free-living microbes) have co-evolved with plants and

supply nutrients to and obtain food from their plant hosts (USDA-NRCS, 2004).

Members of the bacterial families 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 (bacteroids) are capable of reducing (fixing) 

atmospheric nitrogen. The product of nitrogen fixation, ammonia, then can be used by the plant. In 

soybean, atmospheric nitrogen is fixed into ammonia through a symbiotic association with the 

bacterium B. japonicum (Farooq and Vessey, 2009). Since neither soybean nor B. japonicum is 

native to North America, if a field has not been planted with soybean in the last 3 to 5 years, either 

the seed or seed zone must be inoculated with the bacteria prior to soybean planting (Berglund and 

Helms, 2003; Pedersen, 2007).

– 46 –
2.4.4 Biodiversity

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

provides valuable genetic resources for crop improvement (Harlan, 1975). With reference to 

agriculture, biodiversity supports pollination, biological control, and nutrient recycling. These 

processes support competition against pests by natural enemies, improve soil structure, facilitate 

soil and water conservation, suppress disease, control the local microclimate and local hydrological 

processes, and detoxify noxious chemicals (Altieri, 1999).

Relative to any natural ecosystem, species abundance and richness will generally be less in 

intensively managed agroecosystems.22 However, biomass may be higher as a result of introduced 

fertilizers and additional water that would not be present naturally. The degree of biodiversity in an 

agroecosystem depends on four primary characteristics (Altieri, 1999; Palmer et al., undated):

• Diversity of vegetation within and around the agroecosystem;

• Permanence of various crops within the system;

• Intensity of management; and

• Extent of isolation of the agroecosystem from natural vegetation.

Tillage, seed bed preparation, monoculture crop planting, pesticide use, fertilizer use, and harvest may 

all limit the diversity of plants and animals in an agricultural field (Lovett et al., 2003). Herbicide use in 

agricultural fields may impact biodiversity by decreasing weed species and other non-weedy plants

present in the field and the insects, birds, and mammals that utilize those weeds.

Reducing biodiversity may result in a need for costly management practices in order to provide the 

biological functions of pollination, genetic introgression, biological control, and nutrient recycling 

(Altieri, 1999). Woodlots, fencerows, hedgerows, wetlands, and the like have been used to 

introduce biodiversity into large scale monocultures. Other enhancement strategies in 

agroecosystems include intercropping (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 windbreaks (Altieri, 1999).

Agriculture interacts with biodiversity at the crop, farm, and/or landscape level (Carpenter, 2011). 

In this EA, crop diversity refers to the absence of genetic uniformity within crops, farm level

diversity refers to the level of complexity of organisms within the boundaries of a farm, and 

landscape level diversity refers to land use patterns beyond the farm boundaries (Carpenter, 2011).

Each of these levels is described in further detail below.

2.4.4.1 Crop Diversity

Genetic diversity in crops is beneficial as it may improve yields, pest and disease resistance, and 

quality in agricultural systems. Greater varietal and intra-species diversity enables growers to 

maintain productivity over a wide range of conditions (Krishna et al., 2009). The adoption of genetic 

22 An agroecosystem is the organisms and environment of an agricultural area when considered as an ecosystem.

– 47 –
engineering technology might reduce grower demand for crop genetic diversity because breeding 

programs could concentrate on a smaller number of high value cultivars, which could reduce the 

availability of, and demand for, non-genetically engineered varieties (Krishna et al., 2009; Carpenter, 

2011). However, several studies involving genetically engineered soybeans and cotton have found 

this not to be the case, indicating that the introduction of genetically engineered cultivars has not 

decreased crop species diversity (Krishna et al., 2009; Carpenter, 2011).

Concern about the loss of genetic variability for crops has led to the establishment of a worldwide 

network of gene banks. The USDA Soybean Germplasm Collection, which is part of the National 

Plant Germplasm System, acquires, maintains, and evaluates soybean germplasm and distributes 

seed samples to scientists in 35 states (Peregrine, 2003). Nationwide, there are over 

21,850 soybean varieties (USDA-ARS, 2012) that provide a vast reservoir of genetic diversity for 

crop development.

2.4.4.2 Farm-Level Biodiversity

As noted previously, agricultural practices have the potential to impact biodiversity at the farm 

level by affecting local biota, including birds, wildlife, invertebrates, soil microorganisms, and 

other plant populations. For example, increased adoption of conservation tillage practices is 

associated with the use of genetically engineered herbicide-tolerant crops (Givens et al., 2009). 

Less tillage provides more wildlife habitat by allowing other plants to establish between crop rows; 

this benefits biodiversity but may adversely affect crop productivity. Conservation tillage also 

leaves a higher rate of plant residue and increases soil organic matter, which benefit soil biota by 

providing additional food sources (energy) (USDA-NRCS, 1996) and increasing the diversity of 

soil microorganisms, as discussed in Section 2.4.3, Soil Microorganisms. In addition, invertebrates 

that feed on plant detritus and the other animals (invertebrates, birds, reptiles, and mammals) that 

prey on them may benefit from conservation tillage practices (Carpenter, 2011).

Herbicide use in agricultural fields may impact biodiversity by decreasing weed or non-weed plant

quantities or causing a shift in weed or non-weed plant species present in the field, which could 

affect the insects, birds, and mammals that utilize these species. The quantity and type of herbicide 

use associated with crops is dependent on many variables, including cropping systems (including 

non-genetically engineered and genetically engineered varieties), type and abundance of weeds, 

production practices, and individual grower decisions.

2.4.4.3 Landscape-Level Biodiversity

The greatest direct impact of agriculture on biodiversity at the landscape level results from the loss 

of natural habitats caused by the conversion of natural ecosystems into agricultural land. Increases 

in crop yields, as observed in the last 10 years in soybean production, have the potential to reduce 

impacts to biodiversity by allowing less land to be converted to agriculture than would otherwise 

be necessary (Carpenter, 2011). However, substantial gains in yields have generally not been 

obtained by herbicide-tolerant cultivars unless the herbicide tolerance trait has been introduced into 

higher yielding cultivars (NRC, 2010).

– 48 –
The use of herbicides also has the potential to impact biodiversity at the landscape level. Increased 

conservation tillage practices associated with herbicide-tolerant crops at the farm scale but 

implemented over large areas may regionally increase certain populations of invertebrates and 

wildlife that benefit from conservation tillage, whereas the species dependent on the targeted 

weeds may be negatively impacted. For example, it has been suggested that reductions in monarch 

butterfly (Danaus plexippus) populations overwintering in Mexico might be attributed in part to 

loss of host milkweed (Asclepias syriaca) plants in the Corn Belt from the extensive use of 

glyphosate on corn and soybean fields (Brower et al., 2011; Pleasants and Oberhauser, 2012). 

Other factors implicated in the decline in overwintering populations include loss of wintering 

habitat in Mexico (Brower et al., 2011). However, monarch populations are very dynamic because 

of the high reproductive potential of this species and population shifts cannot be easily correlated 

with one factor (Davis, 2011). Potential reductions in landscape-level biodiversity can also result 

from the effects of herbicides on non-target plant species. Such potential impacts on non-target 

plants are managed by adherence to the application requirements stated on EPA-approved 

herbicide labels.

The crop protection industry has taken a proactive approach to helping farmers protect and enhance 

farm-level and landscape-level biodiversity through extensive outreach and education programs. 

For example, along several programs sponsored or supported by one or both companies, Syngenta 

and Bayer provide support to the Coalition for Urban/Rural Environmental Stewardship23 and the 

Center for Integrated Pest Management.

24 These programs promote environmental stewardship and 

provide information and guidance on biodiversity issues such as conservation buffers, wildlife 

habitat, wildlife stewardship, and pollinator health and protection.

2.4.5 Gene Movement in the Natural Environment

For a description of gene flow relating to soybean production, see APHIS PPRA for this petition, 12-

215-01. Gene flow is the movement of genes from one population to another, conferring new traits –

the biophysical characteristics of the source organism – to individuals of the recipient population 

(Quist, 2010). This happens by cross-pollination (also called hybridization): the pollination of members 

of one population or genetic pool with pollen from another. Vertical gene transfer is genetic 

information that is passed ‘down’ from parents to offspring or related species. Horizontal gene transfer

is the passage of genes from one organism to an unrelated one by means other than inheritance. 

Vertical gene flow often results in introgression, the establishment of alleles (gene variants), or wholly 

new genes (as is the case with transgenes) in the recipient population. There is no evidence that 

horizontal gene transfer can naturally occur between unrelated plant species (Stewart et al., 2003).

Characteristics that favor natural hybridization between two populations of related species include 

(Mallory-Smith and Zapiola, 2008):

• Presence of feral populations and uncontrolled volunteers;

• Presence of a high number of highly compatible relatives;

• Self-incompatibility;

23 http://curesworks.org

24 http://pesticidestewardship.org

– 49 –
• Large pollen source;

• Large amounts of pollen produced per plant;

• Lightweight pollen;

• Strong winds (wind pollinated);

• Large insect populations (insect pollinated); and

• Long pollen viability.

None of these characteristics occur in soybeans. Soybean is not native to the US and there are no 

feral or weedy relatives. Soybean is a self-pollinated species, propagated by seed (OECD, 2000a), 

and does not require insects to pollinate flowers. Flowers are typically cleistogamous but, in some 

cultivars and under some conditions, may be chasmogamous and insects may transfer pollen 

(Erickson, 1975; Ahrent and Caviness, 1994; Ray et al., 2003; Chiari et al., 2005). Insect-mediated 

cross-pollination to adjacent plants may occur through pollinating insects such as honeybees.

Incidental pollen transfer by nonpollinating insects occurs at very low frequency (typically less 

than 1 percent with narrow row spacing) (Caviness, 1966; Ray et al., 2003; Yoshimura et al., 

2006). There is little potential for gene flow from one plant to another.

Gene movement can be enabled by dormancy or volunteer characteristics, which can allow the 

plant to survive outside of normal agriculture. Cultivated soybean seed rarely displays any 

dormancy characteristics and only under certain environmental conditions grows as a volunteer in 

the year following cultivation (OECD, 2000a). Volunteer soybean seed is typically not viable after 

the winter period in the northern US. In the southern US soybean seed may remain viable over the 

winter and germinate the following spring (OECD, 2000a; Carpenter et al., 2002). However, 

volunteers do not compete well with the succeeding crop and are easily controlled mechanically or 

chemically. There is a wide range of herbicides available to control volunteers of herbicide-tolerant 

soybean (York et al., 2005). As described in Section 2.1, Soybean Biology, Glycine max is not 

weedy in character and is not found outside of cultivation in North America.

2.5 Public Health

Public health concerns related to soybeans stem from human consumption of soybean and soybean 

food products, animal (livestock) consumption of soybean feed products, and the indirect effect on 

human health and worker safety from laborers’ exposure to agricultural chemicals.

2.5.1 Human Health

Soybean oil makes up 94 percent of the soybean food ingredients consumed by humans (OECD, 

2001a). The essential amino acids required by humans are present in soybean proteins. Soy protein 

products are added to a number of meat, dairy, bakery, and cereal products as protein extenders. Soy 

sprouts, baked soybeans, roasted soybeans, soy flour, and traditional soy foods (miso, soy milk, soy 

sauce and tofu) round out the soy-based products present in the human diet.

Soybeans also contain several antinutrients, with potential effects on humans, that are offset by 

heating or processing (OECD, 2001a):

– 50 –
• Protease inhibitors are active against trypsin and chymotrypsin, and interfere with the 

digestion of proteins resulting in decreased animal growth. The activity of these inhibitors is 

destroyed when the bean or meal is toasted or heated during processing.

• Lectins are proteins that bind to carbohydrate-containing molecules. Lectins in raw soybeans 

can inhibit growth and cause death in animals and, potentially, in humans. Lectins are rapidly 

degraded upon heating.

• Soybeans naturally contain a number of isoflavone compounds reported to possess 

biochemical activity, including estrogenic, anti-estrogenic, and hypocholesterolemic effects, 

in mammalian species. Processing significantly reduces isoflavone isomers in the final soy

products.

• The low molecular weight carbohydrates stachyose and raffinose are considered antinutrients due 

to the gas production and resulting flatulence caused by their consumption. Further processing of 

soybean meal into concentrate or isolate reduces or removes these oligosaccharides.

• Phytic acid chelates mineral nutrients (including calcium, magnesium, potassium, iron, and 

zinc), rendering them unavailable to humans consuming the soybeans.

• Saline extracts of soybeans have been reported to contain several antigenic proteins which 

can orally sensitize humans. The presence of these allergenic proteins in the diet of 

hypersensitive individuals can cause severe adverse reactions in the gastrointestinal tract.

Nontransgenic 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 US 

for human food or animal feed safety prior to release in the market. Under the FFDCA, it is the 

responsibility of food and feed manufacturers to ensure that the products they market are safe and 

properly labeled. Food and feed derived from genetically engineered soybean must be in 

compliance with all applicable legal and regulatory requirements.

Genetically engineered organisms for food and feed may undergo a voluntary consultation process 

with the FDA prior to release onto the market (USDHHS-USFDA, 1992). Although voluntary, thus 

far all applicants who have wished to commercialize a genetically engineered variety of a plant that 

would be included in the food supply have completed a consultation with the FDA. In such a 

consultation, a developer who intends to commercialize a bioengineered food consults 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 (USDHHS-USFDA, 1997). This process includes the developer’s submission of the 

following information to the FDA:

• The purpose or intended technical effect of the modification, and its expected effect on the 

composition or characteristic properties of the food or feed.

• The identity and function of expression products encoded by the introduced genetic material, 

including an estimate of the concentration of any expression product in the bioengineered 

crop or food derived thereof.

– 51 –
• Any known or suspected allergenicity or toxicity of expression products and the basis for 

concluding that foods containing the expression products can be safely consumed.

• Comparison of the composition or characteristics of the bioengineered food to that of food 

derived from the parental variety or other commonly consumed varieties with special 

emphasis on important nutrients and toxicants that occur naturally in the food.

• Discussion of the whether the potential for the bioengineered food to induce an allergic 

response has been altered by the genetic modification.

• Any other information relevant to the safety and nutritional assessment of the bioengineered 

food.

FDA evaluates the submission and responds to the developer by letter with any concerns it may 

have or additional information it may require. Several international agencies also review safety 

associated with food and feed items derived from genetically engineered crops; these agencies

include the European Food Safety Agency (EFSA) and the Australia and New Zealand Food 

Standards Agency (ANZFS).

Foods derived through biotechnology also undergo a comprehensive safety evaluation before

entering the world market, including reviews under standards set by the CODEX, the EFSA, and the 

World Health Organization (FAO and WHO, 2009; Hammond and Jez, 2011). Food safety reviews 

compare the compositional characteristics of the genetically engineered crop with nontransgenic,

conventional varieties of that crop (FAO and WHO, 2009). This comparison also evaluates the 

composition of the modified crop under actual agronomic conditions, including various agronomic 

inputs. Composition characteristics evaluated in these comparative tests include moisture, protein, 

fat, carbohydrates, ash, minerals, dietary fiber, essential and non-essential amino acids, fatty acids, 

vitamins, and antinutrients.

There are multiple ways in which organisms can be genetically modified through human

intervention. Traditional methods include breeding or crossing an organism to elicit the expression of 

a desired trait, while more contemporary approaches include the use of biotechnology such as genetic 

engineering to produce new organisms (NRC, 2004). Unexpected and unintended compositional 

changes arise with all forms of genetic modification, including both conventional hybridizing and

genetic engineering (NRC, 2004). The NRC also noted that (at the time of their study in 2004), no 

adverse health effects attributed to genetic engineering had been documented in the human 

population. Reviews on the nutritional quality of genetically engineered foods have generally 

concluded that there are no significant nutritional differences in conventional versus genetically 

engineered plants for food or animal feed (Faust, 2002; Flachowsky et al., 2005).

2.5.2 Worker Safety

Workers engaged in soybean production may encounter insecticides, herbicides, fungicides, or 

fertilizers that do not pose a worker health or safety risk when used in accordance with the 

agriculture-specific requirements established by EPA in the Worker Protection Standard (WPS)

that protects field workers from the hazards of chemical exposure (USEPA, 1992). The 

Occupational Safety and Health Administration requires all employers to protect their employees 

from hazards associated with chemicals.

– 52 –
Most soybean acreage in the US is treated with pesticides; herbicides are the most commonly 

applied pesticides, but some acres are treated with insecticides and/or fungicides. Changes in 

acreage, crops, or farming practices can affect the amounts and types of pesticides used and thus 

change the risks to workers. Registered pesticides must have use restrictions that, if followed, have 

been determined to be protective of worker health.

EPA-approved measures to limit worker exposure to pesticides are listed on product labels. The WPS 

requires certain actions to reduce the risk of pesticide poisonings and injuries among agricultural 

workers and pesticide handlers. The WPS offers protection to more than 2.5 million agricultural 

workers who work with pesticides at more than 600,000 workplaces on farms, forests, nurseries, and 

greenhouses (USEPA, 2012c). 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.

2.5.3 Animal (Livestock) Health

Animal agriculture consumes 98 percent of the soybean meal produced in the US (GINA, 2011; 

Soyatech, 2012). Poultry consume more than 48 percent of domestic soybean meal (13 million tons), 

with soy oil increasingly replacing animal fats and oils in broiler diets (Soystats, 2010). Other 

animals fed domestic soybean (by crop volumes consumed) include swine (26 percent), beef cattle 

(12 percent), dairy cattle (9 percent), other (e.g., farm-raised fish; 3 percent), and household pets 

(2 percent) (Soystats, 2010). Soybean can be the dominant component of livestock diets: for 

example, upwards of 66 percent of poultry protein intake is derived from soy (Waldroup and Smith, 

undated).

Because of the presence of anti-nutritional factors in raw soybean, there is very limited consumption 

of the unprocessed bean. Most livestock is fed the protein-enriched seed meal left after extraction of 

soybean oil. Treated whole beans, hulls and the vegetative parts of the plant in a fresh or conserved 

state are also used to a limited extent, primarily for cattle. Soybean has a long history in the US as a 

nutritious grazing forage, hay, and silage crop for livestock (Blount et al., 2009). Soybean may be 

harvested for hay or grazed from the flowering stage to near maturity; the best soybean for forage 

is in the beginning pod stage. For silage, it should be harvested at maturity before leaf loss, and

mixed with a carbohydrate source, such as corn, for optimal fermentation characteristics. Varieties 

of soybean have been developed specifically for grazing and hay, but use of the standard grain 

varieties are recommended by some because of the whole plant feeding value (Weiderholt and 

Albrecht, 2003).

Similar to the regulatory control for direct human consumption of soybean under the FFDCA, it is 

the responsibility of livestock feed manufacturers to ensure that the products they market are safe 

and properly labeled. Feed derived from genetically engineered soybean must comply with all 

applicable legal and regulatory requirements, which are designed to protect human health. To help 

ensure compliance, a voluntary consultation process with FDA may be implemented before release 

of genetically engineered plants in animal feed into the market, following the process described 

above. Thus far all applicants who wish to commercialize a genetically engineered variety that will 

be included in the feed supply have completed a consultation with the FDA.

– 53 –
2.6 Socioeconomic Factors

See APHIS EA for 11-202-01 for discussion of socioeconomic issues related to soybean 

production, including domestic economic environment, and foreign economic environment.

2.6.1 Domestic Trade Environment

In 2010, 76 million acres of soybeans were cultivated in the US, yielding 3.3 billion bushels at a 

value of $38.9 billion (USDA-NASS, 2011a). The top ten producing states (Iowa, Illinois, 

Minnesota, Indiana, Nebraska, Ohio, Missouri, South Dakota, Kansas, and North Dakota) 

accounted for more than 80 percent of this production. US inventory in 2010 (2009 remaining 

stocks plus 2010 production) totaled 3.5 billion bushels. Almost all of the US soybean supply 

(95.6 percent in 2009/10) comes from domestic production and almost all of this supply 

(96.8 percent) is either exported or crushed for meal and oil (O’Donoghue et al., 2011; USDAERS, 2011c; USDA-ERS, 2011a). Approximately 43 percent of US soybean is destined for the 

export market (USDA-ERS, 2010b) and the remaining 57 percent of US soybean is primarily 

utilized to produce soybean meal for feed, with lesser amounts processed for soybean oil for 

industrial or consumption purposes; seed and residuals; or ending stock for storage. Only a small 

proportion of the soybean crop is consumed directly by humans (GINA, 2011).

Managing production costs is a major component of 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. USDA-ERS conducts production cost surveys every 

4 to 8 years for each commodity as part of the annual Agricultural Research Management Survey 

(ARMS). Forecasted total 2012 operating costs were $144.21 per planted soybean acre and 

forecasted 2013 operating costs were $146.40. The projected 2013 total costs were comprised of

purchased seed ($61.48), fertilizer and soil amendments ($22.91), other chemicals ($17.54), fuel, 

lubricant, and electricity ($22.18), repairs ($14.71), other variable expenses ($0.15), and interest on 

operating capital ($0.55) (USDA-ERS, 2012c). The rise in crop production input prices is 

attributed to the increased use of more expensive seeds with complex genetic traits, increased use 

of fertilizer that has increased in price primarily in response to rising natural gas prices, and a rise 

in pesticide costs coupled with an increase in overall crop acreage (USDA-ERS, 2012a).

The USDA-ERS recognizes resource regions that vary in terms of land productivity and cost of 

production. The most productive of these regions are the Heartland and Northern Crescent; the least 

productive are the Eastern Uplands, Southern Seaboard, and Mississippi Portal (Fernandez-Cornejo 

and McBride, 2000). While the Heartland and Northern Crescent regions have high production costs, 

their higher productivity results in greater profitability. In 2010, the US total gross average value of 

soybean production per planted acre was $449.32 and the average price of a bushel of soybeans at 

harvest was $9.56 (USDA-ERS, 2011b). Economic returns since 1948 (when record-keeping began) 

have increased from $48 per acre to $486 per acre in 2011, as shown in Figure 2-5.

The US soybean market represents approximately 8 percent of the total value of agricultural sector 

production (USDA-ERS, 2012h) and 25 percent of the value of all field crops (USDA-NASS, 

2012c). Cash receipts from US soybean sales are expected to experience a decline in 2013 from 

2012 values, from $42.6 billion to $38.1 billion (USDA-ERS, 2013d). However, the value of

– 54 –
production is expected to increase from $39.4 billion to $40.5 billion, due in part to the higher 

forecast price described below.

Figure 2-5 Return per Acre of Soybeans, 1948-2011

Source: (USDA-ERS, 2011b)

Note: Excluding government payments

Prices paid to farmers ranged between $4 and $8 per bushel from 1986 until 2006, but in 

subsequent years were in the range of $12 per bushel (Soystats, 2011a). As of early March 2013, 

soybeans prices were at $14.73 per bushel (RCG, 2013) and the price range forecast by USDAERS for the 2012/2013 season was $13.55 to $15.05 per bushel (USDA-ERS, 2013b).

There is a niche market for nontransgenic food and feed in the US, as is evident from private labeling 

initiatives such as the Non-GMO Project.25 This initiative offers third-party product verification and 

labeling for nontransgenic products. There also is a niche market for organic products in the US. 

Sales of organic products have been growing quickly, from $1 billion in 1990 to $26.7 billion in 

2010, with a 7.7 percent increase between 2009 and 2010 alone (OTA, 2011). To satisfy the demand 

for organic soybean, producers have adopted specific production practices to maintain and prevent 

the use of excluded methods as dictated by the NOP. To offset the increase in investment related to 

these more extensive practices, premiums are often paid for nontransgenic or organic soybean. For 

example, the price for non-organic soybean (the majority of which is used for livestock feed) in early 

March 2013 was nearly $14.75 per bushel, as mentioned above, whereas organic soybean for 

livestock feed ranged between $25.00 and $27.25 per bushel (USDA-AMS, 2013).

There is consistent evidence that farmers obtain substantial financial and non-financial benefits as a 

result of adoption of genetically engineered crops as opposed to nontransgenic (but not “organic”) 

crops (Fernandez-Cornejo and McBride, 2000; Fernandez-Cornejo et al., 2002; Duke and Powles, 

2009). These benefits include:

25 http://www.nongmoproject.org/.

– 55 –
• An opportunity to increase income from off-farm labor;

• Increased flexibility and simplicity in the application of pesticides;

• An ability to adopt more environmentally friendly farming practices;

• Increased consistency of weed control;

• Increased human safety;

• Equipment savings; and

• Labor savings.

2.6.2 Foreign Trade Environment

The US was the largest soybean seed producing country in 2011 (the latest year for which 

complete data are available), followed by Brazil and Argentina (Table 2-9). These three exporters 

account for approximately 81 percent of the global soybean exports in the form of harvested seed, 

meal, or oil (USDA-ERS, 2011c). Currently, the US produces approximately 33 percent of the 

global soybean supply (Soystats, 2012a).

Table 2-9 World Soybean Production, 2011

Country

Production

(millions of metric tons) Percent of Market

United States 83.2 33%

Brazil 72.0 29%

Argentina 48.0 19%

China 13.5 5%

Canada 4.2 2%

India 11.0 4%

Paraguay 6.4 3%

Other 13.1 5%

Total 251.5 100%

Source: (Soystats, 2011b)

Table 2-10 presents the leading exporters of bulk soybean, meal, and oil products in 2011/2012

(the latest season for which complete data are available). Forecasts for the 2012/2013 season show 

Brazil exceeding US exports (USDA-ERS, 2013b). The US, along with Brazil, Argentina, 

Paraguay, and Canada, accounted for 97 percent of the bulk soybean exported, while Argentina, 

Brazil, the US, India, and Paraguay accounted for 94.1 percent of the soybean meal exported. 

Argentina, the US, and Brazil are the dominant countries in terms of soybean oil exports,

accounting for 80.2 percent in 2011/2012.

– 56 –
Table 2-10 World Soybean Exports in 2011/12

Location

Soybean Product

Bulk Meal Oil

Exports (thousand metric tons)

Argentina 7.37 26.02 3.78

Bolivia --1 -- 0.32

Brazil 36.32 14.68 1.89

Canada 2.93 -- --

EU-272 -- -- 0.68

India -- 4.60 --

Paraguay 3.10 0.90 0.18

Russia -- -- 0.17

United States 37.06 8.84 0.66

Other 3.55 3.95 0.81

Source: (USDA-FAS, 2012)

1 -- = no data

2 European Union 27 member countries

Table 2-11 presents the top 10 US export markets for soybean by volume for the 2011/2012 

marketing season in comparison to the previous three marketing seasons. China, Mexico, and the 

European Union 27 member countries (EU-27) were the top three importers in the last marketing 

season (USDA-FAS, 2013). US soybean exports are projected to increase to approximately 

1.5 billion bushels (33.2 million metric tons) in 2020 (USDA-OCE, 2011).

Table 2-11 Top 10 US Soybean Export Markets in 2011/2012 Compared to Previous Years

Location

Marketing Season

2011/2012 2010/2011 2009/2010 2008/2009

Exports (metric tons)

China 489,598 303,154 -388 105,832

Germany 75,845 0 65,995 0

Indonesia 20,489 64,059 70,992 80,200

Israel 31,912 0 -22,432 8,000

Japan 63,395 24,874 75,438 50,510

Malaysia 3,057 223 26,160 0

Mexico 113,057 29,816 13,510 33,819

Saudi Arabia 72,575 0 0 0

Thailand 34,105 603 6,240 0

Turkey 27,705 38,235 3,847 18,000

Source: (USDA-FAS, 2013)

– 57 –
US soybean and soy product exports exceeded $21.5 billion in 2011. China was the largest 

customer for US soybeans with purchases exceeding $10.4 billion. Mexico was the second largest 

market for US soybeans with purchases of nearly $1.6 billion. Other significant buyers included 

Japan with purchases of $954 million and Indonesia with purchases of $859 million. Soybeans 

produced in China and India are primarily for domestic use, but China’s imports of soybean are

expected to account for more than 78 percent of the projected global gain in production by 

2019/2020. For the top ten US export customers, the value of soybean and soybean products (meal 

and oil) in 2011 (the most recent year for which detailed data are available) is shown in Table 2-12.

Table 2-12 US Export Markets for Soybean and Soybean Products (2011)

Soybean Exports Soybean Meal Exports Soybean Oil Exports

Location

Value 

($M) Location

Value 

($M) Location

Value 

($M)

China 10,453 Canada 375 Morocco 336

Mexico 1,651 Mexico 369 Mexico 194

Japan 954 Venezuela 260 China 129

Indonesia 859 Philippines 229 Colombia 77

Taiwan 704 Morocco 221 Algeria 72

Egypt 301 Dominican Republic 145 Dominican Republic 71

Germany 286 Japan 119 Venezuela 57

South Korea 267 Guatemala 110 Guatemala 52

Spain 194 Ecuador 84 Canada 47

Thailand 176 South Korea 71 Peru 36

Other 1,720 Other 720 Other 196

Total 17,564 Total 2,702 Total 1,268

Source: (Soystats, 2012b)

2.6.3 Social and Economic Environment

Social issues related to soybeans include farmer and consumer choice, as well as the sustainability

of US soybean farms. Farmers can select from a range of options in agronomic practices, seed 

products (nontransgenic, transgenic, and organic), and markets for their products. Consumers have 

a range of soybean products to choose from in a free market system such as the US.

The rotation of crops between soybean and corn drives much of the economic environment for US 

farmers. Soybean acreage planted in the last 3 years has hovered around 76 to 77 million acres, as 

described in Section 2.2.1, Current and Projected Acreage and Range of Soybean Production. 

Higher per-bushel prices, as described in Section 2.6.1, Domestic Trade Environment, may result in 

the forecasted rebound in soybean plantings for 2013. 

– 58 –
As described in Section 2.2.2.6, Management of Weeds, millions of corn and soybean acres in the 

US are now infested with glyphosate-resistant weeds (Boerboom and Owen, 2006). Nearly

40 million acres are expected to be infested in the US in 2013. The economic impact of these 

resistant weed populations can be significant for growers. One economic analysis places this cost 

in the range of $12 to $18 per acre (Mueller et al., 2005).

Genetically engineered traits such as herbicide tolerance, as described in Section 2.2, Agricultural 

Production of Soybean, offer opportunities for making agriculture more sustainable, as is evident 

by their rapid adoption. The introduction of glyphosate-tolerant soybeans in the US in 1996

revolutionized the way that growers managed weeds in their soybean fields. Growers rapidly 

adopted the technology because of its effectiveness and ease of use, and by 2012 93 percent of 

soybean acres in the US were planted with genetically engineered varieties, virtually all with 

herbicide tolerance traits (USDA-NASS, 2012b).

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3 ALTERNATIVES

The EA analyzes the potential environmental consequences of a determination of nonregulated 

status of SYHT0H2 soybean. To respond favorably to a petition for nonregulated status, APHIS 

must determine that SYHT0H2 soybean is unlikely to pose a plant pest risk.Based on its PPRA 

(USDA-APHIS, 2014b), APHIS has concluded that SYHT0H2 soybean is unlikely to pose a plant 

pest risk. Therefore, APHIS must determine that SYHT0H2 soybean is no longer subject to 7 CFR 

part 340 or the plant pest provisions of the Plant Protection Act. Two alternatives were evaluated 

in this EA: (1) no action and (2) determination of nonregulated status of SYHT0H2 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. SYHT0H2soybeans and 

progeny derived from SYHT0H2 soybeans would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would still 

be required for introductions of SYHT0H2 soybeans and measures to ensure physical and 

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

if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined 

cultivation of SYHT0H2 soybean. 

This alternative is not the preferred alternative because APHIS has concluded through a Plant Pest 

Risk Assessment that SYHT0H2soybean is unlikely to pose a plant pest risk (USDA-APHIS, 

2012). 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 SYHT0H2 Soybean is 

No Longer a Regulated Article

Under the Preferred Alternative, SYHT0H2 soybean and its progeny would no longer be regulated 

articles under the regulations at 7 CFR part 340. SYHT0H2 soybean is unlikely to pose a plant pest

risk (USDA-APHIS, 2012). Permits issued or notifications acknowledged by APHIS would no 

longer be required for introductions of SYHT0H2 soybean and progeny derived from this event. 

The preferred 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 PPA. Because the agency has concluded that SYHT0H2 soybean is 

unlikely to pose a plant pest risk, a determination of nonregulated status of SYHT0H2 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.

– 61 –
3.2.1 Alternatives Considered, Not Included in Detailed Analysis

APHIS has assembled a list of alternatives that might be considered for SYHT0H2 soybean. The 

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

provisions of the PPA, and the regulations at 7 CFR part 340, with respect to environmental safety, 

efficacy, and practicality to identify which alternatives would be further considered for SYHT0H2

soybean. Based on this evaluation, APHIS rejected several alternatives. These alternatives are 

discussed briefly below along with the specific reasons for rejecting each. 

3.2.1.1 Prohibit Any SYHT0H2 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 SYHT0H2 soybean, including denying 

any permits associated with the field testing. APHIS determined that this alternative is not 

appropriate given that APHIS has concluded that SYHT0H2 soybean is unlikely to pose a plant 

pest risk (USDA-APHIS, 2012). 

In enacting the PPA, Congress listed findings in Section 402(4), including the following one:

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

under this title [the Plant Protection Act] shall be based on sound science;”

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 agencies that develop and 

implement policies for oversight of emerging technologies such as genetic engineering. In 

accordance with this memorandum, agencies should adhere to guidance in Executive Order 13563, 

and, consistent with it, apply the following principle, among others to the extent permitted by law 

when regulating emerging technologies:

“Decisions should be based on the best reasonably obtainable scientific, technical, 

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

each agency.” 

Based on the PPRA (USDA-APHIS, 2012), and the scientific data evaluated therein, APHIS 

concluded that SYHT0H2 soybean is unlikely to pose a plant pest risk. Accordingly, there is no 

basis in science for prohibiting the release of SYHT0H2 soybean.

3.2.1.2 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 

– 62 –
concluded that SYHT0H2 soybean is unlikely to pose a plant pest risk, (USDA-APHIS, 2013), and 

it is the only line described in the petition, there is no regulatory basis under the plant pest 

provisions of the Plant Protection Act for considering approval of the petition only in part. 

3.2.1.3 Isolation Distance between SYHT0H2 Soybean and Non-GE Soybean 

Production and Geographical Restrictions 

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating SYHT0H2 soybean from conventional or 

specialty soybean production. However, because APHIS has concluded that SYHT0H2 soybean is 

unlikely to pose a plant pest risk (USDA-APHIS, 2012), an alternative based on requiring isolation 

distances would be inconsistent with statutory authority under the plant pest provisions of the PPA 

and regulations in 7 CFR part 340.

APHIS also considered geographically restricting the production of SYHT0H2 soybean based on 

the location of production of non-GE 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’ PPRA for SYHT0H2 soybean, 

there are no geographic differences associated with any identifiable plant pest risks for SYHT0H2 

soybean (USDA-APHIS, 2012). This alternative was rejected and not analyzed in detail because 

APHIS has concluded that SYHT0H2 soybean does not present a plant pest risk, and will not 

exhibit a greater plant 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 PPA 

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 PPA. However, individuals might choose on their own to geographically isolate their nonGE production systems from SYHT0H2 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 SYHT0H2 soybean is available from the 

Association of Official Seed Certifying Agencies (AOSCA, 2011).

3.2.1.4 Requirement of Testing for SYHT0H2 Soybean

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

USDA to require and provide testing for GE products in non-GE production systems. APHIS 

notes that 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 SYHT0H2 soybean does not pose a plant pest risk ( USDAAPHIS, 2012), the imposition of any type of testing requirement is inconsistent with the plant pest 

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

– 63 –
regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a 

requirement for SYHT0H2 soybean would not meet APHIS’ purpose and need to respond 

appropriately to the petition in accordance with its regulatory authorities.

3.3 Comparison of Alternatives

Table 3-1 summarizes the potential impacts associated with selection of either of the Alternatives 

evaluated in this Environmenal Assessment. The impact assessment is presented in Section 4.

Table 3-1: Summary of Environmental Consequences and Regulatory Compliance

Attribute/Measure

Alternative

No Action Preferred

Meets Purpose and Need, and Objectives No Yes

Unlikely to pose a plant pest risk Satisfied through use of 

regulated field trials

Satisfied through plant pest risk 

assessment 

Soybean Production

Acreage and areas of soybean production The size and distribution of 

soybean production will not 

change much over the next 10 

years

SYHT0H2 is not expected to

change extent of soybean 

production

Cropping practices Continuing use of same 

rotation crops in various 

growing regions depending 

upon economics, markets and 

convenience

SYHT0H2 will not generally alter 

current practices, although 

plantback times may increase for 

some crops and may lead to 

changes in rotations

Pesticide use Patterns of herbicide use may 

see increased use of 

althernatives to glyphosate to 

respond to resistant weeds

Growers with glyphosate resistant 

weeds may begin to use SYHT0H2 

and increase use of mesotrione, 

glufosinate and isoxaflutole and 

decrease glyphosate use with little 

overall change in weed 

management practices. 

Organic soybean production Organic soybean will continue 

increase in production but be a 

small part of total US soybean 

production

Determining nonregulated status of 

SYHT0H2 will not impact organic 

soybean any differently than would 

the No Action alternative

Specialty soybean production Identity preserved soybean 

will continue to respond to 

specialized market

requirements

SYHT 0H2 will have no impacts 

on specialty soybean different from

those of current varieties

Physical Environment

Water quality Current use of conservation 

tillage reduces runoff of 

nutrients and pesticides

SYHT0H2 will not deleteriously 

affect water quality as current 

tillage and irrigation practices are 

continued for production and weed 

control

Soil Use of conservation tillage 

will continue except in some 

circumstances in which tillage 

Soil practices will remain 

unchanged, especially since 

growers will have an additional 

– 64 –
is the only control for 

herbicide resistant weeds

MOA for resistant weeds to allow 

continued use of conservation 

tillage

Air quality Conservation tillage which 

reduces air particulates will 

continue unchanged

No changes expected with 

production of SYHT0H2 soybean

Climate Greenhouse gas production 

from tillage and vehicle 

emissions will likely remain 

unchanged

Production of GHGs will not be 

altered by use of SYHT0H2 

soybean, although in some cases 

where resistant weeds exist, 

additional spraying may be needed 

which may contribute to increased 

GHGs

Biological Environment

Animals Agricultural impacts to crop 

associated animals in general 

will remain unchanged

SYHT0H2 will not change impacts 

on animal populations.

Plants Weeds will continue to 

develop resistance and 

growers will respond with 

other herbicides and cultural 

or mechanical techniques

Management techniques may 

change mostly by use of additional 

herbicide MOAs for growers of 

SYHT0H2 soybean. Cumulative 

use of mesotrione, isoxaflutole and 

glufosinate on corn could increase 

exposure of weeds to these 

herbicides and increase 

possibilities of resistance. 

However, increased availability 

and use of multiple herbicides can 

potentially deter such resistance 

development.

Soil Microorganisms Soil microorganisms will 

continue to be impacted by 

conventional agricultural 

practices with little 

consequence to soybean 

production

SYHT0H2 will not alter 

populations of soil microorganisms

any differently than do

conventional soybean varieties

Biodiversity A variety of EIQs from the use 

of different herbicides may 

impact biodiversity

The EIQs of the three new 

herbicides that would be used for 

soybean in SYHT0H2 are slightly 

lower than for glyphosate, but 

would likely not change 

biodiversity. 

Gene movement No gene flow expected SYHT02 would not change gene 

flow between other varieties of 

soybean

Public Health

Human health Existing varieties have no 

impacts on health

The proteins avHHPD-03 and PAT 

are unlikely to be allergens and are 

not toxic

Animal (livestock) health Current varieties and 

herbicides used on them have 

no health impacts on animals 

that feed on soybean

The SYHT0H2 soybean and 

herbicides applied to it when used 

under EPA restrictions are safe for 

animals exposed to the variety

Worker safety Worker exposure to herbicides Use of EPA registered herbicides 

– 65 –
is regulated by EPA for safety will convey no health risks to 

workers when used according to 

label requirements.

Social and Economic Factors

Domestic trade environment Growers will continue to 

choose varieties based on 

maximizing profits and 

environmental benefits

Additional choices of herbicides to 

improve weed control could 

provide economic benefit to 

growers, increasing price 

competiton for seed and herbicides

Foreign trade environment Additional soybean varieties 

will continue to be developed 

and available to foreign trade

No change in trade is expected, 

although potential exists for 

increasing efficiency in production 

and possible profit increases for 

growers

Social and economic environment No social or economic effects 

are anticipated

Consumer choice or regulatory 

decisionmaking on GE soybean 

would not change

Threatened and Endangered Species Mesotrione, isoxaflutole and 

glufosinate are all registered 

for use on other crops 

including corn, and were 

approved for use following 

restrictions that should 

mitigate possible impacts on 

T&E species

No new herbicides would be used 

on SYHT0H2 other than those 

approved by EPA at similar rates 

for other crops. EPA label 

requirements that take T&E 

species into account will not 

change possible impacts of existing 

herbicides.

Other Regulatory Approvals

US Unchanged for existing non 

regulated varieties

FDA consultation is pending

Compliance with Other Laws

CWA, CAA, ESA, EOs Fully compliant Fully compliant

– 66 –
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– 67 –
4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential environmental consequences addresses the potential impact to the human 

environment from the alternatives analyzed in this environmental assessment. A cumulative 

effects analysis is presented for each potentially affected environmental concern.

 

Potential environmental impacts from the No Action Alternative and the Preferred Alternative for 

SYHT0H2 soybean are described in detail throughout this section. An impact would be any 

change, positive or negative, from the existing (baseline) conditions of the affected environment 

(described for each resource area in Section 3.0). Impacts may be categorized as direct, indirect, or 

cumulative. A direct effect26 is an effect that results solely from a proposed action without 

intermediate steps or processes. Examples could include soil disturbance, air emissions, and water 

use. An indirect effect27 may be an effect that is related to but removed from a proposed action by 

an intermediate step or process. Examples could include surface water quality changes resulting 

from soil erosion due to increased tillage, and worker safety impacts resulting from a change in 

herbicide use.

The EA describes the potential environmental consequences of the two alternatives under 

consideration: the No Action Alternative and the Preferred Alternative. As described in Chapter 3, 

under the No Action Alternative SYHT0H2 soybean would continue to be a regulated article as 

defined by the PPA. Environmental releases of SYHT0H2 soybean would be regulated by APHIS, 

as they have been since 2008.

28 Limited field tests would be allowed, but the product would not be 

marketed. Under the Preferred Alternative, APHIS would determine that SYHT0H2 soybean does 

not pose a plant pest risk. SYHT0H2 soybean would no longer be regulated under the PPA and the 

Petitioners would market this product as a stand-alone product or in breeding stacks with other 

transgenic soybean traits.

A likely indirect effect of deregulating SYHT0H2 soybean is a change in herbicide use, since the 

product includes a unique trait of tolerance to HPPD-inhibiting herbicides (mesotrione and 

isoxaflutole) as well as tolerance to the glutamine synthetase-inhibiting glufosinate (also known as 

glufosinate-ammonium or phosphinothricin). Mesotrione and isoxaflutole29 are not currently used 

on soybeans commercially30; glufosinate is currently used on some non regulated herbicideresistant soybean varieties but only at 3% of total acreage (2012 data, see Table 2-5). The use of 

26 (CEQ, 1978) Section 1508.8, Effects, Paragraph (a), those “which are caused by the action and occur at the same 

time and place.”

27 Section 1508.8, Effects, Paragraph (b), those “which are caused by the action and are later in time or farther 

removed in distance, but are still reasonably foreseeable. Indirect effects may include growth inducing effects 

and other effects related to induced changes in the pattern of land use, population density or growth rate, and 

related effects on air and water and other natural systems, including ecosystems.”

28 Appendix A of the Petition lists permits/authorizations in chronological order.

29 Bayer CropScience’s FG72 soybean (OECD Unique ID MST-FGØ72-2) is a transgenic variety with tolerance to 

isoxaflutole (and glyphosate); APHIS has determined non-regulated status for this product.

30 Mesotrione is currently registered for pre-emergence use on certain soybean varieties that exhibit natural 

tolerance to mesotrione, however this use is currently not on any marketed label and is not being used 

commercially.

– 68 –
herbicides on the SYHT0H2 variety has not yet been approved by EPA, but APHIS will assess the 

potential for increase of herbicide usage as an indirect consequence of the decision for 

nonregulated status. However, APHIS has no direct responsibility for regulating herbicides or 

herbicide impacts. Descriptions of these three herbicides and their uses and potential impacts on 

human health and the environment have been summarized (Appendices A, B, C{Syngenta and 

Bayer, 2013 #287}. These appendices are based primarily on EPA studies and regulatory actions 

since herbicide usage is regulated by EPA, not APHIS. 

A cumulative effects analysis is also included for each environmental issue in Section 5. A 

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

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

actions. Examples include breeding SYHT0H2 soybean with other events that are no longer 

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

from third-party actions (e.g. EPA, growers). 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, a qualitative assessment of potential impacts can be provided. Certain aspects of this 

product and its cultivation may be no different between the alternatives; those are described below. 

This Chapter provides an evaluation of the direct and indirect effects of the No Action Alternative 

and the Preferred Alternative. A cumulative effects analysis is provided in Chapter 5 for selected 

resources, and an evaluation of the potential impacts to threatened or endangered species is 

provided in Chapter 6.

4.1.1 Scope of the Environmental Analysis

In this section, Environmental Consequences, environmental issues are assessed individually. 

However, it should be noted that APHIS has regulatory authority over the MGI soybean plants 

(which is the name Syngenta and Bayer give to seed expressing the SYHT0H2 event), but EPA has 

regulatory authority over herbicides that are applied to the crop. The scope of this EA covers the 

possible direct and indirect impacts that would result primarily from the cultivation and use of the 

plant. EPA, in its registration process, is considering any direct and indirect impacts from the use 

of the herbicide on MGI resistant plants. The USDA is relying on EPA’s authoritative assessments 

and will not duplicate the assessment prepared by EPA. The EA will provide informative 

assessments, but not the determinative document for any impacts of herbicide usage, since that 

analysis will have been completed by EPA under their regulatory authority. USDA also considers 

in this EA(Section 5), cumulative effects that result in the event that USDA approves the petitions 

for non-regulated status to MGI resistant soybean, and EPA registers the use of herbicides on these 

crops.

The Affected Environment section (Section 2) previously described the the resources potentially 

impacted, including soybean production practices as well as physical, biological, public health, and 

socioeconomic resources. The resources analyzed are of public interest or are potentially affected 

by the Preferred Alternative and are commonly addressed in APHIS’s NEPA evaluations of their 

plant pest risk decisions. Resources that have no potential to be affected by the Preferred 

Alternative, such as coastal zones or ambient noise, are not addressed in this assessment.

– 69 –
The Preferred Alternative’s potential direct or indirect effects from SYHT0H2 soybean are 

discussed as a stand-alone crop (i.e., not combined with other transgenic traits through breeding). 

Potential impacts on the analyzed resources deriving from stacked traits are addressed in Section 5, 

Cumulative Impacts and were compared to how those resources may be affected if the No Action 

Alternative is selected. Any impact on the environment which results from the incremental impact 

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

regardless of what agency (Federal or non-federal) or person undertakes such other actions (40 

CFR ~ 1508.7) are also discussed in Cumulative Impacts. Direct effects were considered to be the 

impacts that may result from SYHT0H2 soybean itself; indirect effects were considered to be the 

impacts that may result from other actions (such as changes in herbicide use) that could be induced 

by introducing SYHT0H2 soybean. As noted, APHIS has no authority to regulate these herbicide 

usages or their consequences to agriculture or the environment. Consequently, APHIS has no 

federal requirement under NEPA to assess these indirect effects. 

4.1.2 Assumptions

The analysis of the potential environmental consequences of the No Action Alternative was based 

on the assumption that regulated field trials of SYHT0H2 soybean on small plots of land would 

continue, as described in the Petition. The analysis of the potential environmental consequences of 

the Preferred Alternative was based on the assumption that there would be commercialization of

SYHT0H2 soybean to U.S. growers to the extent noted below in this Section 4.1.2, Assumptions. 

As noted above, the analyses of direct or indirect effects of the Proposed Action are based on 

SYHT0H2 soybean in the absence of stacking with other transgenic traits. The cumulative effects 

analysis provided in Section 5 was based on an assumption that SYHT0H2 soybean will be 

marketed as seed stacked with other transgenic traits.

The environmental consequences of the two alternatives were analyzed under the assumption that the 

majority of farmers who grow transgenic, nontransgenic, or organic soybean are using reasonable, 

commonly accepted best management practices for their chosen system and varieties during soybean

production. These management practices include conventional planting dates, typical seeding rates, 

appropriate harvest times, and acceptable pest management methods as well as preservation and 

coexistence measures. It is assumed that herbicides will be applied in accordance with EPA-approved 

label requirements. It is also assumed that the stewardship plan provided in Appendix F of the Petition 

will be implemented by the Petitioners and that growers will comply with the plan in accordance with 

the Technology Use Agreement provisions for growers.

The environmental consequences of both the No Action Alternative and the Preferred Alternative 

were evaluated in the context of conventional soybean and existing transgenic soybeans developed 

with traits conferring herbicide tolerance. No other transgenic soybean cultivars containing the oatderived transgene avhppd-03, which conveys tolerance of mesotrione and isoxaflutole, have been 

determined as nonregulated by APHIS.

31 Table 2-1 lists transgenic soybean products determined to 

be nonregulated and shows that seven are tolerant of phosphinothricin (also known as glufosinate 

or glufosinate-ammonium) and four are tolerant of glyphosate (USDA-APHIS, 2011). Most of 

31 APHIS has determined nonregulated status for MST-FGØ72-2 soybean, which has an HPPD gene from another 

source.

– 70 –
these crops are marketed as single trait products; one product contains both a glyphosate-tolerance 

trait and an acetolactate synthase-inhibiting trait. Another product contains both an isoxaflutole 

resistant trait (another HPPD inhibitor, as is mesotrione) and a glyphosate resistant trait. Some of 

these cultivars are currently on the market and some have been discontinued or were never 

commercialized.

It is also assumed that mesotrione, isoxaflutole, and glufosinate may replace some portion of the 

current glyphosate use on soybeans. As described in Section 2.2.2.6, Management of Weeds,

herbicide-tolerant soybean varieties now comprise some 93 percent of US plantings, and 

phosphinic acid herbicides (e.g., glyphosate) were used on 77 percent of those fields in 2006 (the 

most recent year for which data are available) (USDA-ERS, 2012f). It is not possible to accurately 

predict what portion of the glyphosate use may be replaced by mesotrione, isoxaflutole, and/or

glufosinate. However, we will assume the estimates of use (12-15% of growers will grow plants 

expressing the traits by five years post launch) provided by the developers do represent a 

reasonable approximation for the adoption rate of SYHT0H2 (Syngenta, 2013). The indirect 

effects analysis of this Section therefore presents the potential impacts from changes in herbicide 

use at these levels.

4.2 Soybean Production

This section describes the potential impacts of the preferred alternative to areas and acreage of 

soybean production, agronomic practices, raw and processed soybean commodities, specialty 

soybean systems, and soybean’s persistence in the environment/weediness potential.

4.2.1 Acreage and Areas of Soybean Production

Substantive changes in soybean production acreage and areas are more likely to result from market 

conditions and changes in federal policies than any other source. Domestic and international 

demand for soybean products, coupled with relatively high soybean commodity prices, is 

increasing (USDA-ERS, 2012g). In response, total US soybean acreage is anticipated to 

incrementally increase from 76.6 million acres in 2010 to 79.5 million acres in 2020, based on 

soybean production trends and projections (USDA-OCE, 2011). Approximately 93 percent of the 

current acreage is planted with transgenic varieties, virtually all being herbicide tolerant (USDANASS, 2011b). In order to accommodate the increase of US soybean acreage in spite of a net 

decrease in available US agricultural land (USDOE-EIA, 2007), growers are likely to plant 

additional soybean acreage at the expense of other crops, such as cotton or hay (USDA-ERS, 

2011c). The use of existing agricultural land in lieu of previously uncultivated land for additional 

soybean acreage is a land-use decision made by growers, as soybean is profitably grown on high 

quality arable land but not on land of lower productivity (USDOE-EIA, 2007).

Arable land for increased soybean planting acreage could also result from the return of CRP lands 

to agricultural production. Although CRP funding has been steady at approximately $1.9 billion 

per year through 2011 (USDA-ERS, 2012b), the 2008 US Farm Bill32 reduced CRP lands from 

32 Food, Conservation, and Energy Act of 2008. Public Law 110-234.

– 71 –
39.2 million acres to 32 million acres.

33 This year growers were offered payments for new 

enrollments on only about 58% of the land that was retired from CRP (Doane-Advisory-Services). 

Following recent trends of enrollment, it is likely that the size of CRP will only be about 24 million 

acres in 2014 (Doane-Advisory-Services). Available acreage for soybean production could 

increase by this federal policy change. However, most soybeans are planted in fields that have been 

in crop production for years, rather than in converted CRP lands. A more likely scenario is that 

other crops displaced by soybean, such as hay or cotton, would be grown on converted CRP lands.

No Action Alternative

The acreage and areas of soybean production would not change as a direct or indirect result of the No 

Action Alternative. Conventional production practices that use transgenic varieties would continue to 

increase under the No Action Alternative, based on current acreage trends. Seed with transgenic traits 

and nontransgenic varieties would continue to be available under the No Action Alternative. Soybean

is currently produced in 31 states (see Table 2-2) and under the No Action Alternative the range of 

production would be unchanged. CRP acreage converted to soybean production would not be 

affected by this alternative. Current trends in the acreage and areas of production are likely to 

continue to be driven by market conditions and federal policy even if SYHT0H2 soybean continues 

to remain a regulated article. Regulated field trials of SYHT0H2 soybean would only impact small 

plots of land with no effect on the acreage and areas of soybean production.

Preferred Alternative

The acreage and areas of soybean production would not change as a direct or indirect result of the 

Preferred Alternative. SYHT0H2 soybean is unlikely to disrupt the relationship between market 

forces and soybean acreage, which is affected by growing demand for soybean commodity 

products (USDA-ERS, 2010c; USDA-ERS, 2010b). SYHT0H2 soybean would not expand 

soybean acreage beyond projected values because it requires similar management conditions as 

other soybean varieties, does not present any yield gains over other soybean varieties, and exhibits 

no phenotypic characteristics that would be indicative of an improved capacity to grow outside an 

agricultural environment (Syngenta, 2012d). Similar to currently available soybean varieties, 

SYHT0H2 soybean will require cultivation on high quality arable land to produce a grower profit, 

precluding the use of lower quality, uncultivated land to supply additional soybean acreage. 

SYHT0H2 soybean is unlikely to be cultivated on land not previously used for agriculture, 

maintaining the trend to shift agricultural land away from other crops toward soybean production 

to satisfy market demand (USDA-ERS, 2010c; USDA-ERS, 2010b).

Growers are not expected to change the acreage or areas of soybean production as a result of 

deregulating SYHT0H2 soybean. CRP acreage converted to crop production would not be affected 

by this alternative. Current trends in the acreage and areas of soybean production are likely to 

continue to be driven by market conditions and federal policy if SYHT0H2 soybean is no longer 

subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant 

Protection Act of 2000.

33 Section 2103, Paragraph (3)

– 72 –
4.2.2 Agronomic Practices

Potential changes in agronomic practices, including cropping practices, irrigation, fertilization, and 

pesticide use, are described below for the No Action Alternative and the Preferred Alternative.

4.2.2.1 Cropping Practices

Various cropping practices are used by soybean growers to improve the performance of their 

operations; some of these practices directly or indirectly control weeds. Growers make choices to 

plant certain varieties and select cropping practices based on factors such as yield, weed and 

disease pressures, cost of seed and other inputs, technology fees, worker safety, potential for crop 

injury, and ease and flexibility of the production system (Gianessi, 2005). Transgenic soybean 

varieties offer a range of herbicide tolerance traits to assist growers in weed management that 

complement cropping practices and other weed management methods, but do not replace those 

methods. Cropping practices are unlikely to change as a result of introducing a new herbicidetolerant transgenic soybean variety to the market.

As described in Section 2.2.2., Agronomic Practices, crop rotation can improve yield and 

profitability over time, control weeds, break disease cycles, limit insect and other pest infestations, 

provide an alternative source of nitrogen, reduce soil erosion, increase soil organic matter, improve 

soil tilth, limit the potential for weeds to develop tolerance to herbicides, and reduce runoff of 

nutrients and chemicals, as well as the potential for contamination of surface water (Al-Kaisi et al., 

2003). Approximately 85 percent of the soybean-planted acreage is in some form of a crop rotation 

system (Quinby et al., 2006); transgenic soybean (with herbicide tolerance traits) accounts for 

93 percent of all soybean fields in the US (USDA-NASS, 2011b), and most of the US soybean 

acreage (approximately 70 percent) is rotated with corn (Heatherly et al., 2009). The economics of 

soybean production drive changes in crop rotation practices as farmers seek the most profitable crop 

and production method. Given the predominance of crop rotation practices and transgenic soybeans, 

any changes in rotation practices are more likely to result from economic and market conditions than 

other factors. Introducing a new transgenic soybean tolerant of a different class (or classes) of 

herbicides is unlikely to have any effect on crop rotation practices.

Other cropping practices that provide some weed control are cover crops and tillage. Both of these 

practices are used in conjunction with other weed control methods, including herbicide use, as part 

of integrated weed management programs. Cover crops are selected for a variety of reasons; 

compatibility with herbicides used on the fields is one factor. Introducing a new transgenic

soybean tolerant of a different class of herbicides could indirectly affect decisions on which cover 

crops may be planted.

Tilling practices under a full (conventional) tillage protocol prepares a field for planting and is used 

in large part for weed control. Farmers increased the use of reduced (conservation) tillage before 

and contemporaneously with the adoption of glyphosate-tolerant soybean varieties (Owen, 2008; 

Bonny, 2011a). Adoption of conservation tillage for soybeans grew (but at a decreasing rate) from 

about 25 percent of the soybean acreage in 1990 to 48 percent in 1995, the 5-year period previous 

to the introduction of herbicide-tolerant soybeans (Fernandez-Cornejo and McBride, 2002).

Conservation tillage continued to increase following the commercialization of glyphosate-tolerant 

– 73 –
soybean in 1996, and totaled 63 percent of soybean acreage by 2007 (Bonny, 2011b). These trends

are likely to be sustained by the continued use of broad-spectrum herbicides (Carpenter and 

Gianessi, 1999). Using a broad-spectrum herbicide such as glyphosate allows less intensive tilling, 

replacing conventional tillage as an economic alternative for weed control (Givens et al., 2009; 

USDA-ERS, 2010a). Farmers already using no-till find herbicide-tolerant seeds can be easily

incorporated into their weed management program, but the commercialization of herbicide tolerant

soybeans does not necessarily encourage adoption of no-till practices (Fernandez-Cornejo and 

McBride, 2002). Introducing a new transgenic soybean tolerant of a different class of herbicides 

could indirectly affect decisions on what types of tilling techniques may be used by facilitating

conservation tillage.

Some soybean growers may return to conventional tillage to manage glyphosate-resistant weed 

populations (NRC, 2010) if use of that herbicide becomes less effective. However, in the absence 

of alternatives the majority of US growers are likely to continue using glyphosate at increased 

rates or frequencies rather than reincorporate conventional tillage into their weed management 

strategies because:

• Conventional tillage is relatively high cost (USDA-NRCS, 2012);

• Growers are familiar with glyphosate (NRC, 2010); and

• Glyphosate-tolerance systems are simple and convenient to implement (Owen, 2010).

Alternative broad-spectrum herbicides with different modes of action than glyphosate may control 

glyphosate-resistant weeds, allowing reductions in glyphosate use and facilitating the continued or 

increased use of conservation tillage practices by controlling weeds through chemical, rather than 

mechanical means.

No Action Alternative

Cropping practices would not change as a direct or indirect result of the No Action Alternative. 

Cover crop use, crop rotations, and tillage practices are likely to continue to be driven by economic 

and market conditions, or convenience and environmental factors, even if SYHT0H2 soybean

continues to remain a regulated article. Various cropping practices would be chosen to meet the 

economic and marketing strategies or the convenience and environmental considerations of the 

particular farmer. Regulated field trials of SYHT0H2 soybean would only impact small plots of 

land with no effect on cropping practices.

Preferred Alternative

Cropping practices such as cover crops, crop and herbicide rotation, and tillage would not change 

as a direct result of the Preferred Alternative. SYHT0H2 soybean exhibits similar agronomic 

performance relative to its nontransgenic parent variety (“Jack”) and would benefit from currently

practiced soybean crop rotation practices. No differences in disease susceptibility were observed 

between SYHT0H2 soybean and its nontransgenic parent variety in experimental plots (Syngenta, 

2012d).

Soybean growers may change their use of cropping practices as an indirect result of introducing 

SYHT0H2 soybean because it is tolerant of a different class of herbicides than the most commonly 

– 74 –
used product, glyphosate. Introduction of SYHT0H2 soybean with mesotrione, isoxaflutole, and 

glufosinate tolerance would have an indirect effect on cropping practices by allowing farmers to 

use a broader range of herbicides to minimize weed development of tolerance to any specific 

chemical. These herbicides are applied at different stages of the crops’ life cycles, and successive 

crops should not be planted when residual concentrations may be present in the fields. Each of the 

herbicides that contains mesotrione, isoxaflutole, or glufosinate as an active ingredient has time 

constraints on when crops may be planted in fields to which these herbicides have been applied. 

Rotation crop plant-backtimes34 for each of the three herbicides when applied to corn are provided 

in Table 4-1; soybean and the most common crops grown in rotation with soybean are indicated in 

bold type. The time constraints for applications of mesotrione and isoxaflutole to soybean fields 

are for nontransgenic soybean (i.e., cultivars that have not been genetically engineered to be 

tolerant of these herbicides) as no soybean varieties tolerant of these herbicides are currently 

marketed.35 The time constraints for applications of glufosinate take into consideration soybean 

varieties tolerant of this herbicide: these varieties may be planted immediately. Although these 

constraints limit herbicide choice by farmers, they also facilitate herbicide rotation, which is an 

integral component of herbicide resistance management.

As noted above, approximately 70 percent of soybean fields are in a crop rotation program with 

corn, which can be planted immediately after an herbicide containing any of these three herbicides 

has been applied. Soybean is grown continuously on up to 15 percent of the fields, and the balance 

of soybean fields are in rotation with a range of crops (wheat, cotton, rice, sorghum, barley, oats, 

and dry beans). A basic tenet of integrated weed management is that herbicides should be rotated 

along with crops, to minimize the potential for development of herbicide-resistant weed biotypes.

Depending upon which herbicide is used, an indirect effect of the Preferred Alternative is that crop 

and herbicide rotation practices should be altered to accommodate these planting restrictions and 

integrated weed management recommendations. Syngenta’s Resistance FighterTM program36 and 

Bayer’s Respect the RotationTM program37 describe the companies’ recommended strategies to 

manage herbicide resistance. These recommendations are encapsulated in the SYHT0H2-specific 

stewardship plan provided in Appendix F to the Petition (Syngenta, 2012d).

A determination of nonregulated status of SYHT0H2 soybean would not directly impact tillage.

Crop and herbicide rotation practices may be altered as an indirect result of the Preferred Alternative, 

which would improve weed resistance management practices. A determination of nonregulated status 

of SYHT0H2 soybean would indirectly prevent a shift towards conventional tillage in soybean

caused by needs to control glyphosate resistant weeds. SYHT0H2 soybean is tolerant of herbicide 

modes of action other than the predominant herbicide, glyphosate, and therefore allows control of 

weeds resistant to glyphosate with additional herbicides. Some of these problem fields haveneeded

to be controlled by means other than herbicides, including tillage, since soybean has fewer options 

for weed control than do some other crops such as corn. 

34 There are slight variations in rotational crop information for different products with other concentrations or 

mixtures of herbicides. 

35 Some varieties of soybean display a natural tolerance of mesotrione, but are not actively marketed as such.

36 http://www.resistancefighter.com/

37 http://www.bayercropscience.us/news/respect-the-rotation

– 75 –
Table 4-1 Examples of Crop Rotation Plant-Back Intervals

Planting 

allowed 

after:

Herbicide

(example product)

Mesotrione (Callisto) Isoxaflutole (Balance Pro) Glufosinate (Liberty)

Crop

0 days Corn (all types), asparagus, 

cranberry, flax, millet (pearl), 

grasses grown for seed (Kentucky 

bluegrass, perennial ryegrass, and 

tall fescue), oats, rhubarb, 

sorghum (grain and sweet), and 

sugarcane

Corn (field) Canola, corn, cotton, rice, soybeans, 

and sugar beets

70 days Root and tuber vegetables, leafy 

vegetables, brassica leafy vegetables 

and small grains (barley, buckwheat, 

oats, rye, teosinte, triticale, and wheat)

120 days 

(4 months)

Small grains Wheat

6 months Soybeans, barley, sweet corn, 

popcorn, potato, grain sorghum, 

and sunflower

All other crops

10 months Alfalfa, blueberry, canola, cotton, 

lingonberry, peanuts, potatoes, 

soybeans, sunflowers, and 

tobacco. If applied post-emergence

following a mesotrione-containing 

pre-emergence herbicide, only 

corn (all types) or grain sorghum 

may be replanted the year 

following application.

Cotton, peanuts, rice; dry beans

and sugar beets east of the 

Mississippi River, and alfalfa in 

all geographic areas

18 months Sugar beets, peas, dry beans, 

snap beans, cucurbits, red clover, 

and all other rotational crops

Dry beans and sugar beets west 

of the Mississippi River, and all 

other crops in all geographic areas

Sources: (Syngenta, 2011a; Bayer, 2012; Bayer, 2013)

Note: Bold type denotes soybean and the most common crops grown in rotation with soybean

4.2.2.2 Irrigation

Supplemental irrigation is used in some soybean production areas, such as the western and 

midsouthern states where summer weather patterns result in drought stress that makes dryland 

– 76 –
production risky. Irrigation rates are affected by local climate conditions (seasonal rainfall), and 

climate change could increase or decrease irrigation rates in some areas.

Herbicide-tolerant soybeans, cultivated on 94 percent of soybean acreage, have facilitated

increased adoption of conservation tillage practices (NRC, 2010). Conservation tillage plays a 

major role in water conservation (USDA-NRCS, 2006a) by reducing evaporation rates and 

irrigation requirements. As discussed previously, conservation tillage trends are not expected to 

change in US soybean production from what is currently practiced; the impacts of conservation 

tillage on irrigation rates are also not expected to change.

No Action Alternative

Irrigation practices would not change as a direct or indirect result of the No Action Alternative. 

Even if SYHT0H2 soybean continues to remain a regulated article, irrigation rates are likely to 

continue to be driven by local weather and climate conditions, as well as increasing adoption of 

conservation tillage techniques. Regulated field trials of SYHT0H2 soybean would only impact 

small plots of land with no effect on irrigation rates.

Preferred Alternative

Irrigation rates are likely to continue to be driven by local weather and climate conditions, and

continued adoption of conservation tillage techniques; these factors would not change as a direct or 

indirect result of the Preferred Alternative.

4.2.2.3 Fertilization

Compared to other crop plants, soybean cultivation requires less nitrogen fertilization because of 

the natural nitrogen-fixing aspect of legumes. USDA-ERS estimates that less than 40 percent of 

soybean acres in the US receive nitrogen fertilizer (USDA-ERS, 2012g; USDA-ERS, 2012e). The

percentage of soybean acreage treated with nitrogen fertilizer, along with application rates of 

nitrogen fertilizer, has remained relatively constant since 1992. Transgenic soybeans with 

herbicide tolerance traits do not affect fertilization rates.

No Action Alternative

Under the No Action Alternative, current rates of fertilizer use in US soybean production would

not change. Even if SYHT0H2 soybean continues to remain a regulated article, fertilization rates 

are likely to continue to be driven by agricultural production needs and the natural characteristics 

of soybean. Regulated field trials of SYHT0H2 soybean would only impact small plots of land 

with no effect on fertilization rates.

Preferred Alternative

A determination of nonregulated status of SYHT0H2 soybean would not change fertilization 

patterns in US soybean production. SYHT0H2 soybean has agronomic performance similar to the 

nontransgenic parent soybean, and only standard agricultural practices are required for the 

cultivation of SYHT0H2 soybean (Syngenta, 2012d).

– 77 –
4.2.2.4 Pesticide Use

Pests that adversely affect soybean production include insects, nematodes, diseases (which may be 

caused by fungi, bacteria or viruses), and weeds. Yield losses in all crops due to pests were 

substantial and widespread until the introduction and adoption of crop protection chemicals in the 

1960s. Growers may use pesticides to control many of these pests: insecticides, nematicides, 

fungicides, and herbicides, as described in the EA to which APHIS referred. Insect injury can 

impact yield, plant maturity, and seed quality; insect pests are therefore managed during the growth 

and development of soybean to enhance soybean yield (Aref and Pike, 1998). Insect injury in 

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

percentage (16 percent) of soybean acreage that receives an insecticide treatment (USDA-NASS, 

2007).

No Action Alternative

The continued emergence of glyphosate resistant weeds under the No Action Alternative will result 

in growers’ selecting appropriate modifications of crop management practices to address these 

weeds. Growers are expected to become less reliant on glyphosate for the control of weeds if it is 

no longer effective in controlling those weeds. However, growers will likely continue to use the 

herbicide because it is still effective on hundreds of weed species. Choices for growers will be to 

seek other management plans based on combinations of present herbicides, use cultivation or 

cultural techniques or seek new herbicide resistant crops that can provide additional options for 

integrated weed management practices.

Selection of glyphosate resistant weeds is expected to continue where glyphosate is used especially 

in those regions where such weeds have already become widely prevalent. Furthermore, because 

other non-glyphosate herbicides will still be used to manage glyphosate resistant weeds, weeds 

resistant to non-glyphosate herbicides will continue to be selected. For many of the non-glyphosate 

herbicides, resistant weeds have already been selected and are widely prevalent. As a result, 

herbicide options for weed management may become less attractive under the No Action 

Alternative and growers may be forced to return to more aggressive tillage systems to maintain 

soybean yields (Prince et al., 2012a).

Other herbicide-tolerant varieties of soybeans may continue to be developed, marketed, and 

planted regardless of whether or not SYHT0H2 soybean continues to remain a regulated article. 

Soybean growers are likely to continue to use the available herbicides and any of the other 

herbicide-tolerant cultivars that are currently available, as listed in Table 2-1, Transgenic Soybean

Cultivars with Herbicide Tolerance Traits that are no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000, or 

any that may be developed and marketed in the future. Regulated field trials of SYHT0H2 soybean

would only impact small plots of land with no effect on herbicide use.

– 78 –
Preferred Alternative

EPA has regulatory authority over herbicides that are applied to the crop. This EA covers the 

possible direct and indirect impacts that would result primarily from the cultivation and use of the 

plant. EPA, in its registration process, is considering any direct and indirect impacts from the use 

of the herbicide on MGI resistant plants. The USDA is relying on EPA’s authoritative assessments 

and will not duplicate the assessment prepared by EPA. This EA will provide informative 

assessments, but not the determinative document for any impacts of herbicide usage, since that 

analysis will have been completed by EPA under their regulatory authority. 

SYHT0H2 soybean is agronomically equivalent to the nontransgenic parent soybean, with equal 

susceptibility to insects, nematodes and disease pathogens. Use of insecticides, nematicides and 

fungicides would not change as a result of deregulating SYHT0H2 soybean. Because 

SYHT0H2 soybean incorporates herbicide tolerance traits, this section focuses on potential 

changes in herbicide use that would indirectly result from a determination of nonregulated status of 

this product.

If APHIS approves the petion for nonregulated status of SYHT0H2 soybean, overall herbicide use 

trends are likely to continue even as mesotrione and isoxaflutole are added to the range of 

approved products for use on soybeans and glufosinate use is expanded. These three herbicides 

would continue to be used on crops grown in rotation with soybeans and potentially replace some 

glyphosate or other approved soybean herbicides. Soybean growers would have a new cultivar to 

plant in addition to conventional varieties and the other herbicide-tolerant varieties that are 

currently available, as listed in Table 2-1, Transgenic Soybean Cultivars with Herbicide Tolerance 

Traits that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant 

pest provisions of the Plant Protection Act of 2000, or any others that may be developed, no longer 

subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant 

Protection Act of 2000, and marketed in the future.

SYHT0H2 soybean would facilitate the use of two other broad-spectrum herbicides, as additional 

options available within an integrated weed management program. Glyphosate use may be reduced 

but mesotrione, isoxaflutole, and glufosinate use would likely increase. Unlike glyphosate,

mesotrione and isoxaflutole have residual activity and may be applied pre-emergence for earlyseason weed control. This allows for greater flexibility in choice and timing of any post-emergence 

herbicide applications. They are also compatible with other herbicides in formulations and tank 

mixes as catalogued on labels for these herbicides. Mesotrione, isoxaflutole, and glufosinate are 

effective against a broad spectrum of weeds (dicots and grasses), including several weed biotypes 

that have developed resistance to glyphosate, acetolactate synthase (ALS) inhibitors, 

protoporphyrinogen oxidase (PPO) inhibitors, or triazine herbicides. Growers will make herbicide 

choices based on a broad range of factors that cannot be accurately predicted; it is not feasible to 

quantify future changes in herbicide use.

The addition of another SOA for soybean would provide potential for reducing development of 

new resistant weeds (Green, 2014)(J. McMillan, Alabama Commisioner of Agriculture, public 

comment, Docket APHIS-2012-0090) especially within comprehensive management programs 

that include multiple SOAs in tank mixes and applications during several crop stages (Norsworthy 

– 79 –
et al., 2012). Alternative weed control options available by planting SYHT0H2 soybean will likely 

reduce the use of glyphosate for soybean weed control, and potentially reduce selection pressure 

for additional development of glyphosate resistant weeds. Still other herbicides currently used for 

soybean weed control, including PPO-inhibiting herbicides such as fomesafen, may also see 

reduced selection pressure with MGI crops (Syngenta, 2013). Another weed management concern 

is the need for circumventing “rescue treatments” for crops with large Palmer amaranth and 

horseweed populations that are becoming resistant; these late applied treatments or high dose 

applications stress crops and reduce yield (Hartzler, 2012). The injurious effects may be averted if 

MGI soybean were widely available for growers (Steckel, L., Univ. Tenn. Agric. Extension, 

Docket APHIS-2012-0090).

Replacing glyphosate use with mesotrione, isoxaflutole, or glufosinate is likely to reduce the 

pounds of active ingredients of herbicides applied to soybean fields since each of the herbicides to 

which SYHT0H2 soybean is tolerant is applied at lower rates than glyphosate. Based on herbicide 

labels, a comparison of the application rates for glyphosate, mesotrione, isoxaflutole, and 

glufosinate is provided in Table 4-2. Because commercial labels for mesotrione and isoxaflutole 

herbicides do not currently specify rates for use on soybean fields, application rates for these 

herbicides are provided as the proposed rates for use on tolerant soybean. These proposed rates 

have been submitted by Bayer and Syngenta to EPA for approval.

Table 4-2 Maximum Herbicide Application Rates for Herbicide Tolerant Soybean

Herbicide (Formulation)

Maximum Application Rate (lb. ai/acre)

Single Annual Total

Glyphosate (e.g., RoundUp1) 1.56 5.95

Mesotrione (Callisto2) 0.20 0.31

Isoxaflutole (Balance Pro3) 0.094 0.094

Glufosinate (Liberty4) 0.53 1.188

NS: Not Specified. 

Sources: 1 (Monsanto, 2012a) Glyphosate is reported as pounds acid equivalent per acre

2 Syngenta proposed soybean use rate 

3 Bayer proposed soybean use rate

4 (Bayer, 2012)

As SYHT0H2 soybean is tolerant to a new mode of action (HPPD inhibition) only recently 

available in soybean (MST-FGØ72-2 soybean, which has been determined as nonregulated), two 

new broad-spectrum herbicides (mesotrione and isoxaflutole) would be available for soybean 

growers to incorporate into an integrated weed management program. Agricultural extension 

programs are both acknowledging the usefulness of the development of new synthetic auxin 

resistant crops and HPPD resistant crops, but suitably reserved about the prospects, noting that 

these “will provide good opportunities to manage some glyphosate-resistant weeds but 

expectations must be set appropriately and an understanding of the potential issues addressed to 

maximize the benefits and minimize the risks” (Iowa-State-Extension, 2014). However, new 

herbicide chemistries are not being introduced, and consequently, greater diversity of weed 

management is needed to respond to emerging problem weeds (Young, B., Purdue Agronomy 

Extension, public comments Docket APHIS-2012-0090) such as offered by crops with new 

– 80 –
herbicide resistance. Additional flexibility in management programs is also offered by mesotrione 

and isoxaflutole because these are both foliar active and soil active, in contrast to the foliar-only 

effectiveness of glyphosate and glufosinate. Proposed patterns of use of mesotrione were made by 

Syngenta and accumulated in more comprehensive plans for weed management and are found in 

Appendix D.

As noted in Section 3.2, Appendix F of the Petition (Syngenta, 2012d) includes a stewardship 

program as an integral part of the Preferred Alternative. The stewardship program includes the 

following elements:

• Technology use grower agreements;

• Integrated weed management and herbicide resistance recommendations;

• Customer education and training;

• Product use information and support; and

• Monitoring of grower use of herbicides.

Specific management recommendations for weed control in soybean and corn to minimize the 

development of herbicide-resistant weed biotypes are:

• Always use a full rate of a residual pre-emergence herbicide as specified on the product label. 

• Do not rely solely on post-emergence applications of HPPD-inhibiting herbicides for control 

of target weeds; integrate other herbicides that are active on the target weeds such as 

glufosinate-ammonium, metribuzin and fomesafen for soybeans or glufosinate-ammonium, 

glyphosate, atrazine, and/or dicamba for corn. 

• For post-emergence herbicide applications, use full labeled rates with recommended 

adjuvants on small weeds. 

• Use herbicide combinations with several modes of action with overlapping efficacy on target 

weeds (i.e., chose herbicide combinations in which each active ingredient is effective against 

the most difficult-to-control target weeds). 

• Strive for full and effective season-long weed control. Control weeds that have escaped 

herbicide treatment, and do not allow weeds to go to seed.

When herbicides are used in accordance with the stewardship program, SYHT0H2 soybean is 

expected to indirectly minimize the potential development of weed resistance to any one herbicide. 

The availability of other herbicides as additional components of integrated weed management would 

reduce the selection pressure on weed species to develop resistance to other methods of control.

Survival of soybean volunteers in the season subsequent to planting may occur with varying impacts; 

usually these are not serious crop competitors, but in some years may reduce yield in corn (Jhala et 

al., 2013). Syngenta-Bayer recommends that these multiply resistant MGI volunteers that arise be 

treated with suitable synthetic auxins such as 2,4-D, or with another soybean selective herbicide such 

as atrazine (Syngenta, 2012). These WSSA Class 4 and Class 5 herbicides have numerous 

alternative herbicide choices for applications to those crops that are frequently rotated with soybean.

– 81 –
4.2.3 Commercial Soybean Production and Uses

This section describes the potential impacts to commercial production of soybean seeds, raw and 

processed soybean commodities, organic soybeans, and specialty soybean products that may occur 

from the No Action and Preferred Alternatives.

4.2.3.1 Seed Production

As described in Section 2.2.3.1, Seed Production, seed purity is accomplished using contracts, 

tracking and traceability systems, quality assurance processes, closed loop systems, and identity 

preservation systems. Seed soybean production differs from commercial soybean production 

because seed companies impose strict requirements to maintain seed identity and high levels of 

genetic purity of the final product. These practices minimize to the extent practical the chance of 

commingling SYHT0H2 soybean seed with other seed. The practices used to maintain seed purity 

do not vary substantively between transgenic and nontransgenic varieties.

No Action Alternative

The availability of methods used to produce seed soybean under the No Action Alternative would 

be the same as in current seed soybean production systems.

Preferred Alternative

Seed soybean production methods would not change as a direct or indirect result of the Preferred 

Alternative. If APHIS approves the petition for nonregulated staus of SYHT0H2 soybean, 

specialty soybean products would continue to be protected by the identity systems established in 

the industry. SYHT0H2 soybean would be produced in a manner similar to other seed soybean

varieties, which are typically produced under identity preservation systems that include contracts 

with growers, traceability, product tracking, and process verification. These procedures minimize 

chances of commingling SYHT0H2 soybean seed with other seed to the same degree as existing 

seed production systems.

4.2.3.2 Raw and Processed Soybean Commodities

As described in Section 2.2.3.2, Raw and Processed Soybean Commodities, soybean seeds are 

processed into a variety of industrial (oil), human dietary, and livestock products. Raw soybeans 

have no human or livestock feed use as they contain anti-nutrient factors; these factors are removed 

by heat processing. There are no differences in handling requirements for processing transgenic 

and nontransgenic soybean.

No Action Alternative

Raw and processed soybean commodities would not change as a direct or indirect result of the No 

Action Alternative. Raw and processed soybean commodities would continue to be handled in 

accordance with regulatory standards and industry practices even if SYHT0H2 soybean continues 

to remain a regulated article. Regulated field trials of SYHT0H2 soybean would only impact small 

plots of land with no effect on raw or processed commodities.

– 82 –
Preferred Alternative

Raw and processed soybean commodities would not change as a direct result of the Preferred 

Alternative. Based on data described in the Petition, SYHT0H2 soybean is not materially different 

from conventional soybean in composition or nutritional value (Syngenta, 2012d). Apart from the 

expected weed control benefits associated with tolerance to mesotrione, isoxaflutole, and 

glufosinate herbicides, SYHT0H2 soybean varieties are agronomically equivalent to their 

nontransgenic counterparts (Syngenta, 2012d). If SYHT0H2 soybean is no longer subject to the 

regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act 

of 2000, raw and processed soybean commodities would continue to be handled in accordance 

with regulatory standards and industry practices.

A determination of nonregulated status of SYHT0H2 soybean would likely result in changes of 

herbicide use types and rates, as described above. Raw and processed soybean commodities may 

be indirectly impacted by deregulating SYHT0H2 soybean as a result of different herbicide 

applications. Depending upon the extent of adoption of the product and application of the 

herbicides, some portion of the commodities would have residual concentrations of mesotrione, 

isoxaflutole, or glufosinate instead of glyphosate. EPA registration of herbicides (including 

mesotrione, isoxaflutole, and glufosinate) includes establishing limits of residual concentrations of 

the herbicides on food and feed commodities to protect human health and the environment. Current 

and proposed residual concentration limits (tolerances) for registered and new uses of these 

herbicides are described in the appendices.

4.2.3.3 Organic Soybean Production

Organic farming operations coexist with farming operations using nontransgenic and transgenic 

varieties for herbicide tolerance. As described in Section 2.2.3.3, Organic Soybean Production, the 

National Organic Program (NOP) requires that organic farms have distinct, defined boundaries and 

buffer zones separating adjoining land not under organic management to prevent unintended 

contact with substances not used in organic fields. Organic production operations must also 

develop and maintain an organic production system plan. Excluded production methods include 

methods used to genetically modify organisms or otherwise influence their growth and 

development by means not possible under natural conditions or processes.

In organic systems, the use of synthetic pesticides and fertilizers is strictly limited, and transgenic 

crops and inputs are prohibited. SYHT0H2 soybean would not be approved for use in organic 

systems because it is transgenic.

Organic soybean acreage represents less than 0.2 percent of the US soybean acreage (USDANASS, 2009a). In contrast to other US organic crops, US organic soybean production has not 

kept pace with demand (USDA-ERS, 2010c), which has generally been met by increasing 

imports from international organic soybean producers (USDA-NASS, 2009a). Organic farmers 

may benefit from proximate transgenic crops with herbicide tolerance traits: neighboring fields 

would not be seed banks for weeds that could infest the organic fields, easing their weed 

management needs.

– 83 –
No Action Alternative

Organic farming practices, including field management to avoid excluded methods and gene 

movement, would not change as a direct or indirect result of the No Action Alternative. Organic 

soybean seed availability would be unaffected by the No Action Alternative. Organic production 

systems and non-organic production systems would continue to coexist in accordance with NOP 

requirements. Organic soybean production would continue to be driven by market conditions if 

SYHT0H2 soybean continues to remain a regulated article.

The amount of transgenic soybean and organic soybean production in the US is increasing, and

current trends suggest that both production practices will likely continue to increase. The use of 

coexistence measures is expected to continue. Organic farms would continue to benefit from the 

weed suppression provided by proximate farms with transgenic crops and low weed populations. 

The availability of seed for soybean varieties that are transgenic, nontransgenic, or used for organic 

production would remain the same. Regulated field trials of SYHT0H2 soybean would only impact 

small plots of land with no effect on organic farming.

Preferred Alternative

Organic farming practices, including field management to avoid excluded methods and gene 

movement, would not change as a direct or indirect result of the Preferred Alternative. Soybean is 

primarily a self-pollinated plant (OECD, 2000a), and there is no reason to expect that the biology 

of SYHT0H2 soybean will increase its potential to outcross with soybean varieties utilized in 

organic soybean production (Syngenta, 2012d). Studies of SYHT0H2 soybean reproductive 

biology revealed no substantial differences in factors influencing reproductive potential, including 

pollen viability, date of emergence, date of 50 percent flowering, and date of maturity (Syngenta, 

2012d).

Organic soybean seed availability would be unaffected by a determination of nonregulated status 

of SYHT0H2 soybean; the seed certification programs described above would continue to operate 

at their current level of effectiveness. Consistent with NOP standards and practices, organic and 

non-organic soybean production systems would continue to coexist. Organic farms would continue 

to benefit from the weed suppression provided by proximate farms with transgenic crops of 

herbicide tolerant varieties, including SYHT0H2 soybean. Organic soybean production would 

continue to be regulated by the NOP and driven by market conditions if SYHT0H2 soybean is no 

longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the 

Plant Protection Act of 2000. A determination of non-regulated status for SYHT0H2 soybean

would not change current practices of organic soybean producers or the growth of organic soybean

production.

Currently, the production of organic and transgenic soybean varieties are both increasing due to 

market demands (although organic production is unable to keep up with demand), and these 

markets would likely continue to increase under the Preferred Alternative. A determination of 

nonregulated status of SYHT0H2 soybean would not increase risks of contamination, via either 

pollinators or post-harvest processing, because the overall percentage of transgenic soybean is not 

expected to increase. SYHT0H2 soybean would not present new and different issues than existing 

herbicide-tolerant soybean cultivars (see Table 2-1) with respect to impacts on organic farmers. 

– 84 –
APHIS has determined as non-regulated the products listed in Table 2-1 based on a finding that 

these other products do not pose a plant pest risk. Availability of SYHT0H2 seed will not lead to a 

decline in availability of organic or non-GE soybean seed for growers, nor to loss of choices for 

consumers. A determination of nonregulated status of SYHT0H2 soybean is unlikely to affect 

US organic soybean production.

4.2.3.4 Specialty Soybean Systems

Potential changes in specialty soybean systems, such as identity preservation, are described for the 

No Action Alternative and the Preferred Alternative in this section.

As with the purity processes described above for seed production, specialty soybean growers and 

end users maintain the identity of their products by contracts, tracking and traceability systems, 

quality assurance programs, closed loop systems, and identity preservation systems.

No Action Alternative

Other specialty soybean production systems would not change as a direct or indirect result of the 

No Action Alternative. Specialty products are likely to continue to be protected by the 

identity-preservation systems established in the industry even if SYHT0H2 soybean continues to 

remain a regulated article. Regulated field trials of SYHT0H2 soybean would only impact small 

plots of land with no effect on other specialty soybean production systems.

Preferred Alternative

Other specialty soybean production systems would not change as a direct or indirect result of the 

Preferred Alternative. If APHIS approves the petition for nonregulated status of

SYHT0H2 soybean, specialty products would continue to be protected by the identity-preservation 

systems established in the industry.

4.3 Physical Environment

This section describes the potential impacts to soil, water quality, air quality, and climate that may 

result from the No Action Alternative and the Preferred Alternative as compared to the existing 

conditions described in Chapter 2.

4.3.1 Soil

As described in Section 2.3.1, Soil, agronomic practices such as crop type, tillage, and pest 

management regimes have greater effects on the biology of the soil than the type of soybean 

cultivated. In particular, tillage can adversely or beneficially impact soil quality (Holland, 2004; 

NRC, 2010). Degraded soil structure and composition may lead to decreased water retention, a 

decrease in soil carbon aggregation and net positive carbon sequestration, and increased 

greenhouse gas emissions. Conservation tillage methods can reduce these adverse effects and have 

been increasingly adopted by soybean growers, partially enabled by the capacity to apply a broadspectrum herbicide (glyphosate) over a tolerant soybean variety (glyphosate-tolerant soybean). As 

– 85 –
discussed in Section 4.2.2, Agronomic Practices, conservation tillage in US soybean is generally 

associated with 30 percent or greater remaining plant residue and reduced soil erosion and 

compaction.

There may be a relationship between the introduction of herbicide-tolerant soybean varieties and 

an increase in the practice of no-till or conservation tillage by US growers. In 1995, before the 

introduction of glyphosate-tolerant soybeans, approximately 27 percent of the US soybean acres 

used no-till production. Approximately 50 percent of soybean acres were planted in no-till systems

by 2009 (Horowitz et al., 2010).

Soil quality may be impacted by the application of herbicides on crops, as an indirect effect of 

transgenic soybean with herbicide tolerance traits, depending upon the chemicals’ persistence in soil. 

Pre-emergence herbicide application would be directly on the soil and post-emergence application 

may result in some portion of the herbicides reaching the ground surface. Plant material could 

transfer herbicide residues into soil via biological activity of the plant or decay after harvest.

No Action Alternative

Soil characteristics would not change as a direct or indirect result of the No Action Alternative. 

The adoption of herbicide-tolerant soybean varieties is expected to continue. The increasing use of 

conservation tillage in US soybean production, an effect attributed to the glyphosate-tolerant 

soybean system, is not expected to change under the No Action Alternative. Insecticide use will 

remain as it is currently practiced and limited to a small percentage of total US soybean acreage 

(USDA-NASS, 2007). Glyphosate is anticipated to remain the most widely applied herbicide in 

US soybean production, continuing the current trend.

Soybean growers would continue current agronomic practices, and further adoption of 

conservation tillage methods is expected even if SYHT0H2 soybean continues to remain a 

regulated article. Regulated field trials of SYHT0H2 soybean would only impact small plots of 

land with no effect on soil characteristics.

Preferred Alternative

Soil characteristics would not change as a direct result of the Preferred Alternative. The new 

proteins expressed in SYHT0H2 soybean would not impact soil quality: compositional analysis of 

SYHT0H2 soybean tissue demonstrates that it is not substantially different from conventional 

soybean (Syngenta, 2012d).

SYHT0H2 soybean production would not change land acreage or cultivation practices for 

transgenic or nontransgenic soybean. Growers would continue current agronomic practices and 

continue to adopt conservation tillage methods regardless of whether SYHT0H2 soybean is no 

longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the 

Plant Protection Act of 2000 no longer subject to the regulatory requirements of 7 CFR Part 340 or 

the plant pest provisions of the Plant Protection Act of 2000 or not. Continued adoption of 

conservation tillage would be facilitated by the addition of other broad-spectrum herbicides to the 

range of weed management tools used by growers. SYHT0H2 soybean is tolerant to mesotrione, 

– 86 –
isoxaflutole, and glufosinate. Thus, conservation tillage trends, and its direct beneficial effects on 

soil quality, are likely to continue as currently practiced.

Soil characteristics would not change as an indirect result of the Preferred Alternative. Mesotrione 

and isoxaflutole would be applied to pre-emergence or to SYHT0H2 soybean fields post-emergence,

but would not adversely affect soil quality. Glufosinate would be applied to SYHT0H2 soybean 

fields post-emergence. As described in the appendices, these herbicides degrade rapidly through 

biotic or abiotic processes. Although the DKN degradate of isoxaflutole is more persistent than the 

parent chemical, soil quality will not be impacted when isoxaflutole is used in accordance with 

EPA label requirements. As a prerequisite to its registration of herbicides (including their 

degradates), EPA determines that there is no unreasonable environmental risk if the end user adheres 

to the label use restrictions during application. Application of isoxaflutole has conditions required for 

soil type, soil organic content, soil water saturation condition or water table height in 15 of 22 states 

registered by EPA to further protect soil and potential for either runoff or soil leaching (see label for 

(Bayer, 2013)).

4.3.2 Water Quality and Use

As described in Section 2.3.2, Water Quality, the primary cause of agricultural nonpoint source 

(NPS) pollution is increased sedimentation from soil erosion, which can introduce sediments, 

manure, fertilizers, and pesticides to nearby lakes and streams. Transgenic soybean is not a 

sediment, fertilizer, or pesticide and therefore is not a major component of agricultural NPS 

pollution. Soybean plant matter could be transferred to water bodies after field harvest, potentially 

accumulating in stream or lake sediments.

Water quality may be indirectly impacted by herbicide-tolerant crops as a result of changes in 

herbicide type and usage rates, as discussed in Section 4.2.2, Agronomic Practices. As described in 

Section 2.3.2, Water Quality, risks to water quality from herbicide use are assessed by the EPA 

during the herbicide registration (and re-registration review) process and are addressed, as 

warranted, through EPA requirements such as application methodology and buffer zones between 

fields, riparian areas, and water bodies, as well as monitoring for herbicide residues in surface and 

ground water.

No Action Alternative

Selection of glyphosate resistant weeds as well as non-glyphosate weeds as a consequence of 

growers using weed management practices not meeting best management practices is likely to 

continue. ;Subsequently, herbicide options for weed management may become less attractive under 

the No Action Alternative. One weed management alternative for growers is a return to more 

aggressive tillage systems to maintain soybean yields, and this has been observed in the Southern 

States(Prince et al., 2012a). When tillage is increased, runoff of soils and any chemicals in soil can 

also be expected to end up in water resources, such as rivers, lakes and ocean bodies. Regions 

where glyphosate resistant weeds have already become widely prevalent are most at risk. 

Furthermore, because other non-glyphosate herbicides will still be used to manage glyphosate

weeds, these also may become more frequently represented in water resources.

– 87 –
Other factors have possible impacts on water quality would continue to be regulated by federal 

programs (some of which have been delegated to certain states) and agronomic practices to protect 

water quality would continue to be implemented even if SYHT0H2 soybean continues to remain a 

regulated article. Herbicide use would continue to evolve as transgenic soybean products with 

herbicide tolerance traits are developed, approved, marketed, and adopted, as described in 

Section 4.2.2, Agronomic Practices. Overall herbicide concentrations in water may change and

water quality as well, independent of the regulatory status of SYHT0H2 soybean. Regulated field 

trials of SYHT0H2 soybean would only impact small plots of land with no effect on water quality.

Preferred Alternative

EPA evaluates risks to water quality when conducting ecological risk assessments as part of the 

herbicide registration review process, as described in the appendices for each of the herbicides that 

would be used on SYHT0H2 soybean. Identified risks are managed by EPA requirements for 

application methods and buffer zones, as specified in EPA-approved labels on each herbicide 

product. As previously noted in 4.3.1 Soil, at one time, nearly 70% of States allowing use of 

isoxaflutole placed restrictions on applied water, soil water conditions and soil qualities for 

application of the herbicide to crops, although that percentage may presently be changing 

(Syngenta, 2013). Labels for herbicides containing isoxaflutole, glufosinate, or mesotrione will be 

submitted by Bayer and Syngenta to EPA for approval of use on SYHT0H2 soybean fields. Based 

on these precautions, increased use of these products is unlikely to result in a substantive adverse 

impact to water quality.

Water quality could potentially show small improvements as an indirect result of the Preferred 

Alternative. SYHT0H2 soybean does not contain any substances that have the potential to affect 

water quality, but the availability of SYHT0H2 could potentially decrease the numbers of 

herbicides applied to control glyphosate resistant crops. Additionally, the availability of more cost 

efficient or effective herbicides that may be used with MGI soybean may delay the adoption of 

non-chemical management strategies under the Preferred Alternative. Fewer growers would be 

expected to adopt aggressive tillage when herbicides remain effective for weed control. Water 

quality would continue to be regulated by federal programs (some of which have been delegated to 

certain states) and agronomic practices to protect water quality would continue to be implemented 

if SYHT0H2 soybean is determined as nonregulated.

A summary of mesotrione’s chemical persistence in water is found in Appendix A. The three 

herbicides to which SYHT0H2 soybean is resistant degrade rapidly and are therefore not persistent 

in surface or groundwater but the degradates may persist under certain conditions (i.e., suboxic 

conditions such as groundwater). The longest persistence was noted for DKN: the aqueous 

degradation half-life of DKN was calculated to be 103 days. As described in the appendix, the 

herbicides and their degradates are unlikely to concentrate or bioaccumulate.

– 88 –
EPA evaluates risks to water quality when conducting ecological risk assessments as part of the 

herbicide registration review process, as described in the appendices for each of the herbicides that 

would be used on SYHT0H2 soybean. Identified risks are managed by EPA requirements for 

application methods and buffer zones, as specified in EPA-approved labels on each herbicide 

product. As previously noted in 4.3.1 Soil, nearly 70% of States place restrictions on applied 

water, soil water conditions and soil qualities for application of isoxaflutole to crops. Labels for 

herbicides containing isoxaflutole, glufosinate, or mesotrione will be submitted by Bayer and 

Syngenta to EPA for approval of use on SYHT0H2 soybean fields. Based on these precautions, 

increased use of these products is unlikely to result in a substantive adverse impact to water 

quality.

Making available additional options for growers to control glyphosate resistant weeds may have 

additional consequences on water resources. In some Southern States, when resistant weed 

infestations and seed production attain high levels, soybean growers who do not have effective 

herbicide alternatives are deep-tilling the seeds to bury them. When these fields, formerly farmed 

as no-till or conservation-till fields, are changed to full tillage, soil water loss is enhanced, and 

additional surface irrigation is needed; in States such as Georgia, supplemental irrigation can 

deleteriously impact water resources (B. Tolar, Georgia Agribusiness Council, personal 

communication). A determination of nonregulated status for SYHT0H2 could improve water 

availability in some regions of soybean cultivation.

4.3.3 Air Quality

As described in Section 2.3.3, Air Quality, agricultural activities such as burning, tilling, harvesting, 

applying pesticides, and fertilizing can directly affect air quality by emitting vehicle exhaust, dust, and 

herbicide sprays. With regard to transgenic soybean with herbicide tolerance traits, burning, harvesting,

and fertilizing practices do not vary between transgenic and nontransgenic agricultural varieties. Air 

quality impacts from aerial application of herbicides may vary slightly between transgenic soybean 

varieties with herbicide tolerance traits and nontransgenic varieties because different herbicides would 

be used for transgenic varieties. Aerial application of herbicides has the potential to impact air quality 

from drift, diffusion, and volatilization of the chemicals, as well as motor vehicle emissions from 

airplanes or helicopters. Potential impacts are managed by adherence to the application 

requirements stated on EPA-approved herbicide labels, including consideration of wind speed 

when spraying. 

Section 4.2.2.4, Pesticide Use, explains that herbicide use can be changed by transgenic herbicide 

tolerant crops, potentially benefitting air quality if chemical use and motorized equipment use can be 

reduced. As discussed in Section 4.2.2.2, Cropping Practices, conservation tillage increases with 

the use of transgenic crops, resulting in lower dust emissions and farm equipment exhaust 

emissions.

No Action Alternative

Air quality would not change as a direct or indirect result of the No Action Alternative. Soybean 

growers would continue current trends in agricultural activities even if SYHT0H2 soybean 

– 89 –
continues to remain a regulated article. Application of herbicides and adoption of conservation 

tillage practices would continue on current trend lines as additional herbicide-tolerant products are 

adopted by growers, reducing impacts to air quality from agricultural activities. Regulated field 

trials of SYHT0H2 soybean would only impact small plots of land with no effect on air quality.

Preferred Alternative

Air quality would not change as a direct result of the Preferred Alternative because the SYHT0H2 

plant does not display any characteristics that would impact air quality. Agronomic practices that 

may affect air quality may be altered as a result of using a different suite of herbicides on 

SYHT0H2 soybean fields: additional passes across the fields may be required in certain instances

to apply a range of herbicides at different times, as part of an integrated weed management 

program. Vehicle exhaust emissions and dust generation may increase, but it is not possible to 

quantify the extent. The herbicides to which SYHT0H2 soybean is tolerant are not volatile and 

therefore would not impact air quality.

4.3.4 Climate

As described in Section 2.3.4, Climate, agriculture-related activities are recognized as both direct 

(e.g., exhaust from motorized equipment) and indirect (e.g., agriculture-related soil disturbance, 

fertilizer production) sources of greenhouse gases (GHGs). Transgenic crops in general have 

reduced the release of GHGs from agriculture, equivalent to removing 5 million cars from the 

roads each year (Brookes and Barfoot, 2005), by reducing equipment use and allowing adoption of 

conservation tillage methods. The permanent CO2 savings arising from reduced fuel use in the US 

attributable to transgenic herbicide-tolerant soybeans in 2008 was 290 million kilograms of CO2

(Brookes and Barfoot, 2010).

The climate can also affect agricultural crop production, and climate change could affect soybean 

yields either positively or negatively. Transgenic soybeans with herbicide tolerance traits are not 

expected to differ from nontransgenic soybean in response to climate change.

No Action Alternative

The climate would not change as a direct or indirect result of the No Action Alternative. Soybean 

growers would continue current trends in agricultural activities even if SYHT0H2 soybean 

continues to remain a regulated article. GHG emission reductions would continue as other 

transgenic varieties are adopted by growers and they seek more energy-efficient methods of 

agriculture. Regulated field trials of SYHT0H2 soybean would only impact small plots of land 

with no effect on the climate. Increases or decreases in soybean yields resulting from climate 

change would not be affected by the No Action Alternative.

Preferred Alternative

The climate would not change as a direct or indirect result of the Preferred Alternative. 

SYHT0H2 soybean production would not change land acreage or cultivation practices for transgenic or 

nontransgenic soybean. As described in the Petition (Syngenta, 2012d), SYHT0H2 soybean requires 

management strategies similar to those for conventional soybean production, and would not affect

– 90 –
agricultural activities that may impact climate change. Growers would continue current trends in 

agricultural activities if SYHT0H2 soybean is no longer subject to the regulatory requirements of 7 

CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000. GHG emission 

reductions would continue as SYHT0H2 soybean and other transgenic varieties are adopted by growers 

and they seek more energy-efficient methods of agriculture. Increases or decreases in soybean yields 

resulting from climate change would not be affected by the Preferred Alternative.

4.4 Natural Biological Communities (Non-Target Organisms)

This section describes the potential impacts to animals, plants, soil microorganisms, biodiversity, 

and gene movement in the natural environment that may result from the No Action Alternative and

the Preferred Alternative as compared to the existing conditions described in Chapter 2. Potential 

impacts to threatened and endangered species are separately described in Chapter 6.

4.4.1 Animals

As described in Section 2.4.1, Animals, soybean fields may be temporarily or permanently 

occupied by many animals including invertebrates, birds, and mammals. Aquatic animals may 

reside in water bodies adjacent to soybean fields. Animals can have positive, negative, or no effect 

on soybean production; herbicide-tolerant soybean varieties do not affect animals but the 

herbicides applied to these crops may.

Most herbicides used on soybeans are only slightly toxic to birds and mammals (Palmer et al., 

undated). Cultural practices that decrease the need for herbicides include rotating crops, selecting 

resistant varieties (when possible), planting and harvesting at the proper time, and using integrated 

pest management techniques. Potential impacts to wildlife are minimized by applying herbicides in 

accordance with EPA label requirements.

No Action Alternative

Animals would not be affected as a direct or indirect result of the No Action Alternative. Animal 

exposure to genetically modified crops containing enzymes tolerant of herbicides would be nearly 

identical to current conditions even if SYHT0H2 soybean continues to remain a regulated article. 

Approved transgenic soybean cultivars would continue to be used by growers and there would be 

no change in animal exposure rates outside of controlled environments (i.e., agriculture). Regulated 

field trials of SYHT0H2 soybean would only impact small plots of land with controlled animal 

incursions.

Preferred Alternative

Animals are not likely to be affected as a direct result of the Preferred Alternative. If 

SYHT0H2 soybean is no longer subject to the regulatory requirements of 7 CFR Part 340 or the 

plant pest provisions of the Plant Protection Act of 2000, animal exposure to genetically modified 

crops with herbicide tolerance would be similar to current conditions. As described in 

Section 4.2.1, Agronomic Practices, land use and agricultural production of SYHT0H2 soybean 

under the Preferred Alternative is likely to continue as currently practiced. There would be no 

– 91 –
direct impact to animal communities as a result of soybean production practices under the 

Preferred Alternative.

Consumption of SYHT0H2 soybean would also not affect animals. Toxicological assessments of 

the two enzymes conferring herbicide tolerance to mesotrione, isoxaflutole, and glufosinate are 

described in the Petition (Syngenta, 2012d). As presented in Section VI.D.3, Conclusions of the 

Toxicological Assessment of AvHPPPD-03, of the Petition,

“The source organism for avhppd-03, oat, is a safely consumed food crop, and the 

enzymatic mode of action of AvHPPD-03 is a native feature of A. sativa HPPD, with no 

toxicological significance to mammals. The bioinformatic analysis showed that 

AvHPPD-03 is most similar to other HPPD proteins in common food crops and does not 

have sequence similarity to any known or putative toxins. In mice, AvHPPD-03 was not 

acutely toxic when administered orally (NOAEL = 2000 mg/kg b.w.38). Therefore, 

AvHPPD-03 is considered to be nontoxic.”

Similarly, as presented in Section VII.E.3, Conclusions of the Toxicological Assessment of PAT, 

of the Petition,

“The PAT protein in SYHT0H2 soybean is from a source organism that is not known to be 

toxic. The PAT protein from S. viridochromogenes is a member of a well-characterized, safe 

class of enzymes with a high degree of substrate specificity, and shows significant homology 

with PAT proteins from other source organisms. Bioinformatic analysis revealed no amino 

acid sequence similarity to any known toxins or other proteins known to cause adverse 

effects, and PAT was not acutely toxic to mice. PAT is therefore considered to be nontoxic.”

Increased use of mesotrione, isoxaflutole, and glufosinate may be an indirect result of introducing 

SYHT0H2 soybean that is tolerant of these other herbicides. The potential risks, as identified by 

EPA’s review of toxicological data, to animals and habitat presented by these herbicides are 

described in the appendices. These risks are managed by proper herbicide application, in accordance 

with the EPA-approved herbicide labels. 

A determination of nonregulated status of SYHT0H2 soybean would not directly or indirectly impact 

animals. An evaluation of ecosystem effects is provided in Section 4.4.4, Biodiversity.

4.4.2 Plants

As described in Section 2.4.2, Plants, soybean fields may be bordered by other agricultural fields 

(including other soybean varieties), woodlands, pasture and grasslands, or wetlands. These

bordering areas may be occupied by non-target plants. Transgenic soybean cultivars with herbicide 

tolerance traits allow growers to change herbicide usage types and application rates to manage 

target plants (i.e., weeds) within fields. Both target and non-target plants may be affected by 

herbicides (target plants are addressed in Section 4.2.2). Impacts to non-target plants outside of 

38 No Observable Adverse Effect Level equals 2,000 milligrams per kilogram (mg/kg) of body weight.

– 92 –
soybean fields may result from herbicide spray drift and volatilization. Such potential impacts are 

managed by adherence to the application requirements stated on EPA-approved herbicide labels.

No Action Alternative

Non-target plants would not be affected as a direct or indirect result of the No Action Alternative. 

Weed management methods would continue following current trends even if SYHT0H2 soybean

continues to remain a regulated article. Weed 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 and other registered herbicides. The majority of U.S. 

soybean acres will continue to be subject to herbicide application. No changes to cultivation 

practices are expected under the No Action Alternative. Isoxaflutole, glufosinate, mesotrione, and 

other approved herbicides would continue to be used on other crops in accordance with label 

requirements that protect non-target plants. Regulated field trials of SYHT0H2 soybean would only 

occur on small plots of land with controlled plant exposures. No impacts to non-target plant species are 

anticipated.

The continued emergence of glyphosate resistant weeds under the No Action Alternative will itself call 

for growers to modify crop management practices to address these weeds. Growers are expected to 

become less reliant on glyphosate for the control of weeds if it is no longer effective in controlling 

problem weeds. However, growers are expected to depend on additional chemical and non-chemical 

methods to control the glyphosate resistant weeds. Changes in management practices will likely 

include more use of non-glyphosate herbicides and adjustments to crop rotation and tillage practices 

(Owen et al., 2011). 

Preferred Alternative

Non-target plants would not be affected as a direct result of the Preferred Alternative. 

SYHT0H2 soybean production would not change land acreage or cultivation practices for 

transgenic or nontransgenic soybean. Target plants (i.e., weeds) would be affected by the Preferred 

Alternative, as intended. This alternative, by allowing the use of herbicides with different modes of 

action than are currently available for use on soybean, will indirectly help prevent or delay the 

evolution of herbicide resistance among target weed species, and help deter shifts in weed 

populations to those that are naturally tolerant to present soybean herbicides that are predominately 

used by growers.

SYHT0H2 soybean would facilitate the new or increased use of some herbicides in US soybean 

production. Mesotrione, isoxaflutole, and/or glufosinate would likely be applied to fields planted 

with this herbicide-tolerant variety, possibly in combination with other herbicides registered for use 

on soybeans. These herbicides would also continue to be used on rotational crops in the same 

fields. Non-target plants may be potentially affected from herbicide volatilization or spray drift as 

an indirect result of the Preferred Alternative.

While weed resistance to HPPD inhibitor herbicides appears to be limited (Heap, 2013), a recent 

report suggests that one weed type may be of increasing importance. The earliest resistance to 

HPPD inhibitor herbicides arose from repeated applications of two herbicides from this class, and 

– 93 –
this occurred only in the specialized circumstance of seed corn production. Reports from Iowa 

now indicate that between 24 and 27% of waterhemp populations have resistance to HPPD class 

herbicides (Iowa-State-Extension, 2014). The use of this herbicide in soybean production regions 

with existing HPPD weed resistance will need to take into account that increased probability. 

Growers will unquestionably need to heed the requirement planned for inclusion in the Technical 

Use Agreement for MGI seed purchasers, which is to use overlapping herbicide sites of action to 

target susceptibilities of multiply resistant and principal weeds (Iowa-State-Extension, 2014).

As explained in the appendices for the herbicides that would be used on SYHT0H2 soybean

(Sygenta and Bayer, 2013), volatilization is not likely for these compounds due to their low vapor 

pressure. Spray drift has the potential to impact non-target plants or may affect the quality of 

stormwater or irrigation water run-off. The potential risks to non-target plants presented by these 

herbicides (as identified by EPA’s review of toxicological data) are described in the appendices. 

These risks are managed by proper herbicide application, in accordance with the EPA-approved 

herbicide labels. 

There would be no new off-target impacts associated with application of the three herbicides 

(mesotrione, isoxaflutole, and glufosinate) to SYHT0H2 soybean when they are used in 

accordance with label directions. EPA has determined that there is no unreasonable environmental 

risk if the end user adheres to the label use restrictions when applying herbicide formulations. 

Herbicide labels specify application equipment and methodology to minimize spray drift. For 

Restricted Use Pesticides (e.g., isoxaflutole), requirements specify that applications must be made 

by a certified applicator to minimize effects on nearby environments.

4.4.3 Soil Microorganisms

As described in Section 2.4.3, Soil Microorganisms, the main factors affecting microbial 

population size and diversity include soil type (texture, structure, organic matter, aggregate 

stability, pH, and nutrient content), plant type (as providers of specific carbon and energy sources 

into the soil), and agricultural management practices (crop rotation, tillage, herbicide and fertilizer 

application, and irrigation). Planting transgenic soybeans does not substantively change any of 

these factors except agricultural management practices. The changes in crop rotation, tillage 

practices, fertilizer application, and irrigation outlined in Section 4.2.1, Agronomic Practices, are 

not expected to substantively affect soil microorganisms. Herbicide types and application rates can 

be changed by growers when new herbicide-tolerant cultivars are available; herbicides that persist 

in soil and are toxic to microbes have the potential to affect soil microorganisms.

Glyphosate can alter the microbial ecology and biology of the rhizosphere environment. Increased 

fungal populations that develop under glyphosate treatment of glyphosate-resistant soybean may 

adversely affect plant growth and biological processes in the soil and rhizosphere (Kremer et al., 

2005). Field studies conducted in Missouri during the 1997 to 2007 period assessed effects of 

glyphosate applied to glyphosate-resistant soybean and maize on root colonization and soil 

populations of Fusarium and selected rhizosphere bacteria (Kremer and Means, 2009). Frequency

of root-colonizing Fusarium increased significantly after glyphosate application during growing 

seasons in each year at all sites. Roots of soybean and maize treated with glyphosate were heavily 

– 94 –
colonized by Fusarium compared to non-glyphosate-resistant or glyphosate-resistant cultivars not 

treated with glyphosate. These studies hypothesized that root-exuded glyphosate may serve as a 

nutrient source for fungi and stimulate propagule germination.

No Action Alternative

Soil microorganisms would not be affected as a direct or indirect result of the No Action 

Alternative. Soybean cultivation would continue as currently practiced. Microbes in the field 

would continue to be exposed to common agronomic practices, including herbicide applications to 

soybean fields. The use of transgenic soybean with herbicide tolerance traits would continue 

following current trends even if SYHT0H2 soybean continues to remain a regulated article. 

Regulated field trials of SYHT0H2 soybean would involve only small plots of land with controlled 

plant exposures. No impacts to soil microorganisms compared to any effects from current 

agronomic practices are anticipated.

Preferred Alternative

Soil microorganisms would not be affected as a direct result of the Preferred Alternative. As stated 

in the Petition (Syngenta, 2012d), SYHT0H2 soybean phenotype characteristics do not differ 

substantively from its nontransgenic parent variety and the new enzymes are not toxic. Soil 

microbial interaction with plant tissue would not have any effect.

Herbicides have the potential to impact soil microbes if the herbicides are toxic to them. As 

described in the appendices, studies of mesotrione, isoxaflutole, and glufosinate have found no to 

minimal impacts to soil microorganisms. The Preferred Alternative would not have an indirect 

adverse affect on soil microorganisms.

4.4.4 Biodiversity

Biological diversity, or the variation in species or life forms in an area, is highly managed in 

agricultural fields. Biodiversity in an agroecosystem (the organisms and environment of an 

agricultural area when considered as an ecosystem) depends (Altieri, 1999) on the:

• Diversity of vegetation within and around the agroecosystem;

• Permanence of crops within the agroecosystem;

• Intensity of management; and

• Extent of isolation from natural vegetation.

Farmers typically plant crops that are genetically adapted to grow well in a specific area of 

cultivation and have been bred for a specific market. Farmers want to encourage high yields from 

their crop, and will intensively manage plant and animal communities through chemical and cultural 

controls to protect the crop from damage. The biological diversity in agricultural fields is therefore

lower than in the surrounding habitats. Although soybean production fields are cultivated as plant 

monocultures to optimize yield, the adjacent landscape may harbor a wide variety of plants and 

animals. Most transgenic crops increase the productivity of cultivated lands, so biodiversity is 

protected because additional land is not needed for the same volume of crop production.

– 95 –
A qualitative and relative comparison of the potential for ecological impacts of herbicides can be 

made by calculating an “environmental impact quotient” (EIQ) based on the application rate and 

percentage of active ingredient in marketed products. The EIQ method was developed by 

integrated pest management specialists at Cornell University to help fruit and vegetable growers of 

New York State to evaluate low impact pest-control options (Levitan, 1997). A composite EIQ 

score is calculated for each pesticide active ingredient using an algebraic equation that combines

the numerical ratings assigned to eight environmental parameters. The underlying premise of the 

EIQ method is to screen for potential impacts that might result from the interaction of toxicity and 

exposure. In conducting EAs of herbicide-tolerant transgenic plants, APHIS has used the EIQ 

method to compare the environmental effects of herbicide usage on a relative basis (e.g., 

Environmental Assessment, Bayer Petition 09-328-01 for Determination of Nonregulated Status of 

Double Herbicide-tolerant Soybean (Glycine max) Event FG72 and Final Environmental Impact 

Statement, Glyphosate-Tolerant Alfalfa Events J101 and J163: Request for Nonregulated Status).

In order to assess relative impacts to ecosystems, the calculation provides an “ecological” EIQ 

based on application rates of herbicide active ingredients, rather than toxicity of the pure 

compound to fish, birds, bees, and beneficial organisms (NYS-IPM, 2012). Table 4-3 compares the 

ecological EIQ ratings of the top ten herbicides used on soybeans currently (see Figure 2-3) and the 

three herbicides of which SYHT0H2 soybean is tolerant (listed in bold type), using the maximum 

annual application rates for soybeans on the referenced product labels, or the proposed rates for the 

new use on transgenic SYHT0H2 soybean (see Table 4-2). Table 4-3 also provides an overall 

“field use” EIQ rating, which combines the ecological EIQ with worker and consumer ratings 

based on toxicity to humans.

These ratings provide a qualitative comparison of the potential overall environmental effect of 

using these herbicides. Table 4-3 shows that the ecological EIQ can vary considerably from the 

overall field use EIQ, as the percentage of active ingredient and the application rate substantively 

affect the final score. The dominant herbicide used on soybeans, glyphosate, has a slightly higher 

ecological EIQ (indicating higher environmental impact) than the three herbicides of which 

SYHT0H2 soybean is tolerant.

– 96 –
Table 4-3 EIQ Ecological and Overall Field Use Rating of Selected Herbicides

Herbicide

Environmental Impact 

Quotient Rating1

Common Name

Example 

Formulation

Percent 

active 

ingredient

Maximum Annual

Application Rate 

(per acre)

Overall 

Field Use Ecological 

2,4-D Dimethylamine 

salt

2,4-D Amine 42a 46.8 2 pts 19.32b 29.0

2,4-D 

Dichlorophenoxyacetic acid

Weedone 

LV6EC3a

87.3 1.5 pts 21.83b 44.5

Chlorimuron Classic4a 25.0 1.5 oz 0.54b 1.0

Clethodim Clethodim 

2EC5a

26.4 32 fl oz 9.05b 16.4

Fomesafen Flexstar6a 22.1 1.6 pts 8.66b 11.5

Glyphosate Roundup7a 48.7 44 fl oz 20.57b 46.9

Imazethapyr Pursuit8a 22.9 4 oz 1.18b 1.9

Metribuzin Sencor DF9a 75.0 1.34 lb 28.59b 69.4

Pendimethalin Prowl10a 38.7 4.0 pts 46.710b 113.0

Trifuralin Treflan HFP11a 43.0 4.0 pts 32.411b 72.2

Glufosinate Liberty12a 18.2 62 fl oz 14.212b 30.0

Isoxaflutole Balance Pro13a 40.5 3 fl oz 1.813b 3.0

Mesotrione Callisto14a 40.0 10 fl oz 4.714b 8.3

Sources:1- (NYS-IPM, 2012)

2a- (Albaugh, Undated) 2b- (NYS-IPM, 2013b)

3a- (Nufarm, Undated) 3b- (NYS-IPM, 2013a)

4a- (DuPont, 2012) 4b- (NYS-IPM, 2013c) Note: this herbicide is commonly tank-mixed with other herbicides such as glyphosate

5a- (Willowood, 2011) 5b- (NYS-IPM, 2013d)

6a- (Syngenta, 2010b) 6b- (NYS-IPM, 2013e)

7a- (Monsanto, 2012a) 7b- (NYS-IPM, 2013g)

8a- (BASF, 2011) 8b- (NYS-IPM, 2013h)

9a- (Bayer, Undated) 9b- (NYS-IPM, 2013k) Note: this herbicide is not currently marketed in the US; the application rates are for a Canadian 

formulation

10a- (BASF, 2012) 10b- (NYS-IPM, 2013l)

11a- (Dow, 2008) 11b- (NYS-IPM, 2013m)

12a- (Bayer, 2012) 12b- (NYS-IPM, 2013f)

13a-(Bayer, 2013) 13b- (NYS-IPM, 2013i)

14a- (Syngenta, 2011a) 14b- (NYS-IPM, 2013j)

No Action Alternative

Biodiversity would not be affected as a direct or indirect result of the No Action Alternative. 

Biodiversity within agroecosystems would continue to be affected by agricultural practices 

following current trends. Growers would continue to have access to herbicide-tolerant soybean

varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant 

pest provisions of the Plant Protection Act of 2000, and adoption of new transgenic soybean

– 97 –
varieties would be expected to continue even if SYHT0H2 soybean continues to remain a regulated 

article. Animal and plant species that typically inhabit soybean production fields or adjacent land 

will continue to be affected by currently utilized management plans and systems, which include the 

use of mechanical, cultural, and chemical control methods. Regulated field trials of 

SYHT0H2 soybean would only involve small plots of land with controlled animal and plant 

incursions. No changes in biodiversity compared to effects from current agronomic practices are 

anticipated.

Preferred Alternative

Biodiversity would be unchanged as a result of the Preferred Alternative. SYHT0H2 soybean is not 

toxic and does not exhibit any different agronomic traits or require different agronomic practices

(Syngenta, 2012d). As described in Section 4.4.1, Animals, and Section 4.4.2, Plants, animal and 

plant species that typically inhabit soybean production areas would be managed the same as for 

other herbicide tolerant soybean products on the market. The four determinants of biodiversity in 

an agroecosystem listed above are likely to remain unchanged under the Preferred Alternative.

As shown in Table 4-3, isoxaflutole, glufosinate, and mesotrione display relatively low EIQ ratings 

as compared to the top ten other herbicides used on soybean, and in particular glyphosate. Adding 

new transgenic soybean cultivars with tolerance of isoxaflutole, glufosinate, and mesotrione would 

be likely to increase the use of these herbicides but, as demonstrated by the lower EIQ scores than 

the most commonly used herbicide (glyphosate), would not adversely affect biodiversity.

4.4.5 Gene Movement in the Natural Environment

Soybean is principally a self-pollinated species, propagated by seed (OECD, 2000a). As described 

in Section 2.4.5, Gene Movement in the Natural Environment, there is no evidence that horizontal 

gene transfer can naturally occur between unrelated plant species. Genetic engineering artificially 

accomplishes horizontal gene transfer, but does not impart natural gene transfer.

Cross-pollination to adjacent plants of other soybean varieties occurs at a very low frequency (0 to 

6.3 percent as measured in experimental treatments) (Caviness, 1966; Ray et al., 2003; Yoshimura 

et al., 2006). As described in Section 2.2.5, Persistence in the Environment/Weediness Potential, 

cultivated soybean seed rarely displays any dormancy characteristics and only under certain 

environmental conditions grows as a volunteer in the year following cultivation, minimizing the 

potential for vertical gene movement. The soybean plant is not weedy, and there are no wild 

relatives outside of Asia.

No Action Alternative

Soybean’s characteristic of limited gene movement in the natural environment would not be 

affected as a direct or indirect result of the No Action Alternative. Soybean breeding by traditional 

or transgenic means would continue even if SYHT0H2 soybean continues to remain a regulated 

article. Regulated field trials of SYHT0H2 soybean would only impact small plots of land with 

minimal potential for exposure to sexually compatible plants (i.e., other soybean plants) or 

– 98 –
unrelated plants. No changes in the natural gene movement characteristics of current soybean

varieties are anticipated.

Soybean’s persistence in the environment and weediness potential would not be affected as a direct 

or indirect result of the No Action Alternative. Soybean breeding by traditional or transgenic 

means would continue even if SYHT0H2 soybean continues to remain a regulated article. 

Regulated field trials of SYHT0H2 soybean would only impact small plots of land with minimal 

potential for exposure to sexually compatible plants (i.e., other soybean plants). No changes in 

these characteristics of current soybean varieties are anticipated.

Preferred Alternative

Soybean’s characteristic of limited gene movement in the natural environment would not be 

affected as a direct or indirect result of the Preferred Alternative. As described in the Petition 

(Syngenta, 2012d), it is theoretically possible that the transgenes avhppd-03 or pat could enter the 

soil. However, multiple reviews have concluded that there is minimal likelihood of horizontal gene 

transfer between transgenic plants and soil microorganisms (Keese, 2008). Should avhppd-03 or 

pat from SYHT0H2 soybean be integrated into a plasmid or chromosome of a bacterium, it is 

highly unlikely that AvHPPD-03 or PAT proteins will be produced, because the codon use in 

avhppd-03 and pat is optimized for expression in plants, not bacteria. It is highly unlikely that 

AvHPPD-03 or PAT will be produced in soil via transformation of bacteria with genes from 

SYHT0H2 soybean.

Soybean’s persistence in the environment and weediness potential would not be affected as a direct 

or indirect result of the Preferred Alternative. Cultivation of SYHT0H2 soybean will not lead to the 

transfer of avhppd-03 and pat to wild relatives of soybean because they are not present in the US.

The weediness potential of soybean has not been altered by SYHT0H2 soybean. Germination and 

dormancy characteristics of SYHT0H2 soybean seed are no different than those of conventional 

soybean seed (Syngenta, 2012d). The introduced traits in SYHT0H2 soybean are not intended to 

affect the range or frequency of soybean outcrossing, and phenotypic data show no indication 

that the genetic modification resulted in enhancement of reproductive characteristics of 

SYHT0H2 soybean compared with conventional soybean (Syngenta, 2012d).

4.5 Public Health

This section describes the potential impacts to human health, animal (livestock) health, and worker 

safety that may result from the No Action Alternative and the Preferred Alternative as compared to 

the existing conditions described in Chapter 2.

4.5.1 Human Health

In theory, transgenic products could impact human health because of possible toxic or nutritional 

effects of the products, or how the product might change the allergenicity of food products. As 

described in Section 1.1, Regulatory Authority, 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 transgenic products must be in compliance with all applicable legal and regulatory 

– 99 –
requirements. Transgenic products for food and feed also routinely undergo a voluntary 

consultation process with the FDA prior to release onto the market. To date, all transgenic crops 

marketed in the US have been the subject of pre-marketing consultations with the FDA.

No Action Alternative

Human health would not be affected as a direct or indirect result of the No Action Alternative. 

Transgenic soybean that are no longer subject to the regulatory requirements of 7 CFR Part 340 or 

the plant pest provisions of the Plant Protection Act of 2000 would continue to be used as food for 

human consumption. Human exposure to SYHT0H2 soybean would be limited to those individuals 

involved in cultivation under regulated conditions even if SYHT0H2 soybean continues to remain 

a regulated article. Regulated field trials of SYHT0H2 soybean would only impact small plots of 

land with no potential for exposure to the general public. Exposure to existing transgenic and 

nontransgenic soybean would not change under this alternative.

Preferred Alternative

Human health would not be affected as a direct result of the Preferred Alternative. If 

SYHT0H2 soybean is no longer subject to the regulatory requirements of 7 CFR Part 340 or the 

plant pest provisions of the Plant Protection Act of 2000, the general public would primarily come 

in contact with the introduced transgenic proteins (i.e., AvHPPD-03 or PAT) through dietary 

exposure to food and products derived from SYHT0H2 soybean, although most processed products 

would contain no detectable AvHPPD-03 or PAT residues. The lack of human health effects from 

the lack of changes in nutritional value, potential exposure to constituents of SYHT0H2 soybean, 

and potential exposure to herbicides are described below.

The Petition (Syngenta, 2012d) states that an analysis of key nutritional components of forage and 

seed from SYHT0H2 soybean identified no differences from conventional, nontransgenic soybean 

that would affect human or animal health. No unintended, adverse consequences of the 

transformation process or expression of the transgenes in SYHT0H2 soybean were evident in any 

test. Seed, forage, and soybean meal from SYHT0H2 soybean were found to be similar in 

composition to those same materials from conventional soybean. SYHT0H2 soybean exhibits a 

compositional profile similar to that of reference soybean varieties grown concurrently in several 

locations and other soybean varieties.

Soybean is one of the most commonly implicated sources of food allergy. SYHT0H2 soybean seed 

was assessed to determine whether its endogenous allergen content differed from that of a 

nontransgenic, near-isogenic control soybean (variety ‘Jack’) or commercially available 

nontransgenic soybean reference varieties (Syngenta, 2012d). SYHT0H2 soybean was determined 

to be comparable to and as safe as conventional soybean varieties and will not pose greater health 

risks to soybean-allergic consumers than nontransgenic soybean.

The Petition also states that both AvHPPD-03 and PAT are homologous with proteins in many 

species to which humans and animals are exposed daily without concern (Syngenta, 2012d).

AvHPPD- 03 and PAT do not share significant amino acid similarity to known toxins and are not 

acutely toxic in mice. AvHPPD-03 and PAT are unlikely to be human allergens.

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AvHPPD-03 is derived from a safely consumed endogenous protein in a common food crop, oat

(Syngenta, 2012d). Oat contains no endogenous proteins that are listed in the Food Allergy Research 

and Resource Program (FARRP) Allergen Protein Database39 and therefore is not considered to be a 

known allergenic food. Oat has been implicated as a potential source of proteins that cause celiac 

disease in humans; however, a recent review of the literature clarified that this risk has likely been 

confounded by the use of test materials that were not pure oats (HealthCanada, 2007). Pure oats can 

be consumed by celiac disease patients who are otherwise sensitive to foods such as wheat and barley 

(which contain the proteins associated with celiac disease and are listed in the FARRP Allergen 

Protein Database).

HPPD enzymes, as a group of biochemically and structurally related proteins, are ubiquitous in 

commonly consumed food plants and animals, and the level of AvHPPD-03 in SYHT0H2 soybean 

is low (Syngenta, 2012d). AvHPPD-03 is not acutely toxic in mice and has no significant amino 

acid sequence similarity to known toxins or allergens. Bioinformatic analysis and assays for 

digestibility, heat inactivation, and glycosylation status provided in the Petition indicate that 

AvHPPD-03 is unlikely to be a food allergen. AvHPPD-03 is not likely to pose a risk to the health 

of humans or other mammals through consumption of SYHT0H2 soybean.

PAT has been safely used and consumed in commercially available transgenic crops and has a 

permanent EPA tolerance exemption in all crops under 40 CFR § 174.522. It has a history of safe use 

in numerous transgenic crop varieties that are no longer subject to the regulatory requirements of 7 

CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000. The PAT protein 

produced in SYHT0H2 soybean has been characterized and tested to determine its potential for 

causing adverse effects in humans and livestock (Syngenta, 2012d). The PAT protein in 

SYHT0H2 soybean is from S. viridochromogenes (a member of a well-characterized, nonpathogenic

group of bacteria), shows a high degree of substrate specificity, and shows significant homology with 

PAT proteins from other source organisms. Bioinformatic analysis revealed no amino acid sequence 

similarity to any known toxins or other proteins known to cause adverse effects, and PAT was not 

acutely toxic to mice. PAT is therefore considered to be nontoxic.

PAT is also unlikely to be a food allergen. It is derived from a source organism that contains no 

known allergens, it is not significantly similar in amino acid sequence to any known allergens, and, 

as expressed in SYHT0H2 soybean, it shows no glycosylation (Syngenta, 2012d). Furthermore, 

PAT is produced at very low levels in soybean seed, its enzyme activity is completely inactivated 

at 55°C, and it is rapidly degraded in simulated mammalian gastric and intestinal fluids. PAT is not 

similar to known allergens, and little or no dietary exposure to intact PAT protein would occur in 

humans or other mammals via consumption of SYHT0H2 soybean.

Human health assessments from potential exposure to herbicides are described in the appendices. 

Each of the three herbicides that would be applicable to SYHT0H2 soybean (mesotrione, 

isoxaflutole, and glufosinate) are registered with EPA. EPA’s review process has determined that 

these herbicides and their degradates present no unreasonable risk to human health when used in 

accordance with EPA-approved label requirements.

39 http://www.allergenonline.org/databasebrowse.shtml

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The Petitioners have initiated a pre-market consultation process with FDA and submitted a Safety 

and Nutritional Assessment for SYHT0H2 soybean (Syngenta, 2012d). The assessment documents

a lack of toxicity of the introduced AvHPPD-03 and PAT proteins in SYHT0H2 soybean for 

human and animal consumption, and a lack of allergenicity concerns for humans. No adverse 

impacts to human health, either directly or indirectly, are expected from a determination of 

nonregulated status of SYHT0H2 soybean.

4.5.2 Worker Safety

As described in Section 2.5.3, Worker Safety, pesticides, including insecticides, fungicides and/or

herbicides, are used on most soybean acreage in the US; herbicides are the most commonly used 

pesticides on soybean. The EPA’s Worker Protection Standard (USEPA, 1992) requires employers 

to take actions to reduce the risk of pesticide poisonings and injuries among agricultural workers 

and pesticide handlers. The restrictions and precautions for worker safety associated with most

herbicides include:

• Personal Protective Equipment (chemical-resistant gloves and other skin protection, eye 

protection, respirators, etc.) or other measures (closed-system applications) to minimize 

applicator exposure;

• Minimum worker reentry intervals post application; and

• Minimum preharvest intervals post application.

Large-scale cultivation of transgenic herbicide-tolerant soybean has increased since its introduction 

in 1996. As described in Section 2.2.2.6, Management of Weeds, the volume of herbicide active 

ingredients has been trending downward since the introduction of herbicide-tolerant soybeans in 

1996, but glyphosate use has been trending upward. The actual health risk that workers experience 

is based on the specific chemicals to which they may be exposed and the chemical handling 

procedures used, as described above. Prior to registering a pesticide, EPA conducts an in-depth 

worker safety evaluation, and imposes strict requirements for personal protective equipment, field 

reentry intervals, and specific handling instructions for mixing, loading and applying the product.

No Action Alternative

Agricultural workers and pesticide applicators would continue adhere to the restrictions required 

by the variety of registered herbicides such as those approved by EPA for use on soybeans under 

the No Action Alternative. Chemical herbicide use rates would likely continue to evolve as new 

varieties of herbicide-tolerant transgenic soybean are adopted, allowing a more diverse weed 

management program. Worker exposure to herbicides would be managed by following application 

requirements listed on product labels. Approved transgenic soybean cultivars would continue to be 

used even if SYHT0H2 soybean continues to remain a regulated article. Regulated field trials of 

SYHT0H2 soybean would only impact small plots of land with limited potential for exposure to 

agricultural workers. Under the No Action Alternative, agricultural workers and herbicide 

applicators would continue to be exposed to a variety of chemicals including mesotrione, 

isoxaflutole, and glufosinate on crops other than soybeans.

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Preferred Alternative

The Preferred Alternative would not have a direct impact to worker safety, as the SYHT0H2 soybean 

does not display any characteristics that pose a risk to workers from exposure. The Preferred 

Alternative would likely result in the use of different herbicides on soybean fields than currently, 

potentially indirectly affecting workers. EPA-registered isoxaflutole, glufosinate, and mesotrione 

herbicides that are currently used on other crops would be available for use by soybean growers 

under the Preferred Alternative. As described in Section 4.2.2.4, Pesticide Use, trends in herbicide 

use are likely to continue as a direct result of the Preferred Alternative. The addition of a new 

herbicide-tolerant soybean variety would allow the use of herbicides not currently applicable to 

soybeans, diversifying the tools available to growers as part of an integrated weed management 

program. Instead of increasing applications of glyphosate to manage weeds that are developing 

resistance to this herbicide, these other herbicides could be used. As described in the appendices, 

EPA’s review of toxicological studies has shown that these herbicides present no unreasonable risk 

to humans. EPA’s label requirements are intended to minimize or eliminate risks to workers from

exposure during application.

4.5.3 Animal (Livestock) Health

As described in Section 2.5.2, Animal (Livestock) Health, livestock ingestion of feed from 

transgenic crops, with subsequent human ingestion of livestock food products, is a potential 

concern about transgenic crops. Several whole and processed fractions of soybeans contribute to 

the total animal diet (OECD, 2001a). The main soybean product fed to animals is defatted/toasted 

soybean meal, generally not exceeding 15 percent of the animals’ diet. Aspirated grain fractions, 

forage, hay, hulls, seed, silage, and bakery products containing soybean oil are also fed to cattle. 

Hay and hulls are also fed to poultry, and soybean aspirated grain fractions, hulls, and seeds have 

been fed to swine.

Section 2.5.2, Animal (Livestock) Health, explains that approximately 27 million tons of soybean 

meal are used annually for animal feed, representing nearly 70 percent of the total annual soybean 

meal production. As approximately 93 percent of the soybean produced in the US is transgenic, it 

may be assumed that the majority of soybean livestock feed is also transgenic. As discussed in 

Section 4.5.1, Human Health, soybean has anti-nutrient qualities that can be removed by heat 

processing, and transgenic soybean does not vary in this regard from nontransgenic soybean. The

proteins that convey herbicide tolerance are derived from natural sources, have been tested for 

safety, and are not expected to be toxic in mammals or poultry. Changes in herbicide use types or 

rates that could conceivably result from introducing herbicide-tolerant cultivars may indirectly 

impact livestock if safe exposure levels are exceeded.

No Action Alternative

Animal (livestock) health would not be affected as a direct or indirect result of the No Action 

Alternative. Livestock would not be exposed to SYHT0H2 soybean if it continues to remain a 

regulated article. Transgenic soybean that are no longer subject to the regulatory requirements of 7 

CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 will continue to be 

used as feed for animal consumption, and adoption of transgenic soybean varieties would be 

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expected to continue. Exposure to existing transgenic and nontransgenic soybean would not change 

under this alternative. Regulated field trials of SYHT0H2 soybean would only impact small plots 

of land with no potential for exposure to livestock.

Preferred Alternative

Animal (livestock) health would not be affected as a direct or indirect result of the Preferred 

Alternative. Processing SYHT0H2 soybean for livestock feed would be unchanged from current 

practices. SYHT0H2 soybean and soybean meal processed from raw SYHT0H2 soybeans are 

nutritionally and compositionally comparable to raw and processed soybean from conventional 

varieties (Syngenta, 2012d). SYHT0H2 soybean is expected to provide adequate nutrition as part 

of formulated diets delivered to growing livestock.

If SYHT0H2 soybean is no longer subject to the regulatory requirements of 7 CFR Part 340 or the 

plant pest provisions of the Plant Protection Act of 2000, livestock would primarily come in 

contact with the introduced AvHPPD-03 and PAT proteins in SYHT0H2 soybean through feed 

products derived from SYHT0H2 soybean. As described in Section 4.5.1, Human Health, these 

proteins are not toxic. Livestock would not be adversely affected by consuming 

SYHT0H2 soybean containing these introduced proteins.

The Petitioners have initiated a voluntary pre-market consultation process with FDA and submitted

a Safety and Nutritional Assessment for SYHT0H2 soybean in August 2012 (Syngenta, 2012c). 

The assessment documented a lack of toxicity of the introduced AvHPPD-03 and PAT proteins in 

SYHT0H2 soybean animal consumption. No adverse impacts to livestock, either directly or 

indirectly, are expected from deregulating SYHT0H2 soybean.

Different herbicides may be used by soybean growers as a result of deregulating SYHT0H2 soybean, 

potentially changing livestock exposure to herbicides. Potential impacts to livestock health are 

minimized by adherence to EPA-approved label requirements. For example, the herbicide labels for 

Callisto® (containing mesotrione), Balance Pro® (containing isoxaflutole), and Liberty® (containing 

glufosinate) include precautions on time limits when certain crops may not be used as forage or feed

after herbicide application.

4.6 Socioeconomic Factors

This section describes the potential impacts to the domestic trade environment, foreign trade 

environment, and social and economic environment that may result from the No Action Alternative 

and the Preferred Alternative as compared to the existing conditions described in Chapter 2.

4.6.1 Domestic Trade Environment

The majority of soybean production in the US is utilized domestically for animal feed, with lower

amounts and byproducts used for oil or fresh consumption (USDA-ERS, 2010a; GINA, 2011). As 

described in Section 2.6.1, Domestic Trade Environment, the estimated value of the 2012 US 

soybean production to meet these demands as well as export requirements (described below) is 

$34.5 billion. In 2011, transgenic products comprised 93 percent of the planted soybean to satisfy this 

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demand (USDA-ERS, 2011c). The transgenic traits include herbicide tolerance and improved oil 

content, as described in Section 2.1, Soybean Biology. Overall, harvest security and quality are better 

with herbicide-tolerant soybean. Farm income is positively impacted by herbicide-tolerant soybean

by reducing production costs (e.g., reduced tillage for weed management and, potentially, reduced 

herbicide use). Section 2.2.2.6, Management of Weeds, explains that soybean yield losses can range 

from 12 to 80 percent if weeds are uncontrolled for an entire season.

Economic advantage is a key indicator and useful index for comparing glyphosate-tolerant soybean

to conventional weed control programs, and is instructive for anticipating changes to the domestic 

trade environment that may result from the introduction of other herbicide-tolerant soybean 

varieties. The unprecedented high rate of acceptance and adoption of glyphosate-tolerant soybean 

in industrial and developing countries demonstrates the economic advantage of glyphosate-tolerant 

soybean (Carpenter et al., 2002). A major impact of the introduction of glyphosate-tolerant 

soybean has been a reduction in weed control costs for soybean farmers. As early as 1997, weed 

control costs for glyphosate-tolerant soybean adopters were lower than those incurred by 

nonadopters (Lin et al., 2001). Manufacturers of conventional herbicides soon reacted to their 

declining market share by decreasing the prices of conventional herbicides, such as imazethapyr 

and chlorimuron, by as much as 40 percent (Carpenter et al., 2002). The result has been a reduction 

in weed control costs for both adopters and nonadopters of glyphosate tolerant soybean. It was 

estimated that in 2000, US soybean farmers would spend $307 million less on weed control than in 

1995 (Carpenter and Gianessi, 1999). A recent economic impact for one weed control system

(comprised of a combination of herbicides and herbicide-tolerant corn, cotton, and soybean)

estimated that adoption of the system could add $1.9 billion in net farm revenue in 2011 alone, 

with increasing benefits over time (Dow, 2011); this money would be otherwise spent on 

alternative herbicide and tillage programs to control glyphosate-resistant weeds.

Despite the rapid adoption of herbicide-tolerant soybeans, there was little impact on net farm returns 

in 1997 and 1998 (Fernandez-Cornejo and Caswell, 2006). It may be that the adoption of herbicidetolerant soybeans is associated with increased off-farm household income, suggesting that farmers 

adopt this technology because the simplicity and flexibility of the technology permit them to save

management time, allowing them to benefit from additional income from off-farm activities.

Herbicide-tolerant soybean varieties offer growers greater flexibility in the timing and choice of 

herbicide applications. The benefits attributable to herbicide-tolerant soybeans and their distribution 

are very dependent on the soybean supply elasticity (Fernandez-Cornejo and Caswell, 2006).

No Action Alternative

The domestic trade environment would not be affected as a direct or indirect result of the No Action 

Alternative. Growers would continue to make choices to plant certain soybean varieties and use 

certain crop rotation practices based on factors such as yield, weed, disease and other pest pressures, 

cost of seed and other inputs, technology fees, worker safety, potential for crop injury, and ease and 

flexibility of the production system (Gianessi, 2005). The No Action Alternative would not affect 

available options for growers and therefore not affect the domestic trade environment. 

SYHT0H2 soybean would remain a regulated article and would require an APHIS permit or 

notification for release into the environment. Regulated field trials of SYHT0H2 soybean would only 

impact small plots of land with no impact on the domestic trade environment.

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Preferred Alternative

The Preferred Alternative would not directly impact the domestic trade environment; 

SYHT0H2 soybean does not offer any agronomic or yield advantages over other soybean cultivars 

currently on the market. However, the domestic trade environment could be positively affected as 

an indirect result of deregulating SYHT0H2 soybean, although accurate projections are not 

possible. Growers would have an additional set of herbicides to use for weed control on soybean 

fields if SYHT0H2 soybean is no longer subject to the regulatory requirements of 7 CFR Part 340 

or the plant pest provisions of the Plant Protection Act of 2000, potentially reducing economic loss 

from weed competition and economic cost from weed control. More effective weed management 

offered by expanding an integrated weed management program would minimize yield losses and 

help preserve the efficacy of weed management systems.

The Preferred Alternative could also indirectly result in economic benefit from increased competition 

in the seed and herbicide markets. The availability of multiple herbicide-tolerant products would 

increase grower choice and price competition, potentially resulting in lower seed prices for growers. 

The option to use different herbicides may have a similar effect on herbicide prices.

4.6.2 Foreign Trade Environment

As described in Section 2.6.2, Foreign Trade Environment, the US produces approximately 33 percent 

of the global soybean supply and the primary US soybean export destinations include China, Mexico, 

Japan, and Indonesia. These countries do not have major barriers for importing food or feed 

commodities produced from transgenic crops, including those with herbicide tolerance traits. Soybean

exports to European Union countries have generally declined since the Common Agricultural Policy 

limited grain imports and EU membership has expanded (USDA-ERS, 2011a); exports to Europe may 

increase slightly in 2013 due to economic conditions, physical constraints, and climate issues elsewhere 

(USDA-ERS, 2013c).

No Action Alternative

The foreign trade environment would not be affected as a direct or indirect result of the No Action 

Alternative. Additional genetically modified soybean varieties would continue to be developed and 

available in the foreign trade market. SYHT0H2 soybean would remain a regulated article and 

would require an APHIS permit or notification for release into the environment. Regulated field 

trials of SYHT0H2 soybean would only impact small plots of land with no impact on the foreign 

trade environment. There would be no change in imports to other countries, including the 

European Union, as a result of the No Action Alternative.

Preferred Alternative

The foreign trade environment would not be affected as a direct or indirect result of the Preferred 

Alternative. Worldwide market conditions and destination country approval of transgenic crop 

commodities would continue to be factors for international soybean prices, without regard to the 

presence or absence of SYHT0H2 soybean on the market. A determination of nonregulated status of 

SYHT0H2 soybean would not adversely impact the foreign trade economy and may potentially 

enhance it through more efficient production of soybean supplies worldwide.

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The Petitioners intend to apply to foreign agencies for approval of the unconfined environmental 

release and food and feed use of soybean commodities and processed goods containing 

SYHT0H2 soybean. Regulatory filings for SYHT0H2 soybean import approvals have been made 

in Canada, Argentina, Japan, Republic of China, South Korea, Republic of South Africa, Australia 

and New Zealand, and the European Union. Regulatory filings in additional countries, including 

the People’s Republic of China, are planned. The foreign trade economic impacts associated with a 

determination of nonregulated status of SYHT0H2 soybean are anticipated to be very similar to the 

No Action Alternative.

4.6.3 Social and Economic Environment

As described in Section 2.6.3, Social and Economic Environment, farmers have a range of options 

in agronomic practices, seed products to choose from, and opportunities for sale to customers. 

Consumers have a range of soy products to choose from. Section 4.2.3.3, Organic Soybean 

Production, explains that growers may choose to grow transgenic, nontransgenic, or organic 

soybeans, and obtain price premiums for growing varieties of soybean for particular markets. 

Regulatory agency requirements (under the Federal Food, Drug, and Cosmetic Act and the 

National Organic Program, for example) and consumer advocacy groups promote food product 

safety and consumer choice.

No Action Alternative

The social and economic environment would not be affected as a direct or indirect result of the No 

Action Alternative. SYHT0H2 soybean would remain a regulated article and would require an 

APHIS permit or notification for release into the environment. Regulated field trials of 

SYHT0H2 soybean would only impact small plots of land with no impact on the social and 

economic environment.

Preferred Alternative

The social and economic environment would not be affected as a direct or indirect result of the 

Preferred Alternative. Regulatory programs and consumer choice would be unchanged by a 

determination of non-regulated status of SYHT0H2 soybean.

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5 CUMULATIVE EFFECTS

This Chapter describes the potential cumulative effects that may result from the Preferred 

Alternative. In accordance with CEQ regulations, this evaluation considers the potential effects 

that, although individually minor, could have a collectively significant impact on the environment 

when added to other past, present, and reasonably foreseeable future actions.

5.1 Introduction

The CEQ regulations (CEQ, 1978) define a cumulative effect as “the impact on the environment which 

results from the incremental impact of the action when added to other past, present, and reasonably 

foreseeable future actions regardless of what agency (Federal or non-Federal) or person undertakes 

such other actions. Cumulative impacts can result from individually minor but collectively significant 

actions taking place over a period of time.” For example, for USDA-APHIS cumulative effects may 

include the impacts associated with a determination of nonregulated status of a genetically engineered

crop in combination with the future production of crop seeds with multiple traits that are no longer 

subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA. A 

cumulative impact may also result from the use of an herbicide with a similar mode of action to that of 

the intended herbicides described in the Petition for nonregulated status.

Based on the information provided in Sections 4.2 through 4.6, which is summarized in Table 3-1, 

the Preferred Alternative would not have substantive direct or indirect adverse impacts to soybean 

production practices or the physical, natural, social, or economic environment. If SYHT0H2 soybean

is no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions 

of the Plant Protection Act of 2000, some resources may be beneficially impacted to a minor degree, 

as compared to the No Action Alternative. This cumulative effects evaluation reviews only those 

resources that may be directly or indirectly impacted by deregulating SYHT0H2 soybean, whether 

the impacts are adverse or beneficial. Resources that would not be impacted by the Preferred 

Alternative are not subject to the cumulative effects evaluation.

In the event that APHIS reaches a determination of nonregulated statusof SYHT0H2 soybean this 

soybean varerity could be combined (“stacked”) with nontransgenic and transgenic soybean 

cultivars that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest provisions of the PPA. Such transgenic cultivars could include those listed in Table 2-1 as 

well as other varieties for which Environmental Assessments are in process or petitions for 

nonregulated status that are in review and subsequently approved . This could result in a plant 

variety that, for example, may be resistant to additional herbicides and contain other transgenic 

traits such as increased oil or fatty acid production. APHIS’s regulations at 7 CFR part 340 do not 

provide for agency oversight of transgenic soybean varieties that are no longer subject to the 

regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act 

of 2000, nor over stacked varieties combining transgenic cultivars that are no longer subject to the 

regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act 

of 2000, unless it can be positively shown that such stacked varieties are likely to pose a plant pest 

risk. Any herbicides that would be used on a stacked product have been subject to EPA’s 

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registration process and review for impacts to human health and the environment; approved 

herbicides pose little risk when used in accordance with label requirements. This cumulative 

effects analysis therefore evaluates the combination of the transgenic traits that may occur from 

SYHT0H2 soybean stacked with other traits, and the combination of additional herbicides that may 

be used on fields of the stacked product, rather than the individual impacts of other transgenic traits 

or other herbicides.

The analyses provided in the following sections discuss the potential cumulative impacts to selected 

resources that may result from the direct and indirect effects of a determination of nonregulated 

status of SYHT0H2 soybean when combined with other past, present, and reasonably foreseeable 

future actions. There is no indication in the Petition (Syngenta, 2012d) that SYHT0H2 soybean will 

be stacked with any particular transgenic variety that is no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000, as 

company plans, third-party licensing negotiations, and market demands play a significant role in 

those business decisions. Predicting all potential combinations of stacked varieties that could be 

created using both transgenic soybean cultivars that are no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 and 

nontransgenic soybean cultivars is hypothetical and speculative. Because it is not possible to identify 

specific varieties of stacked transgenic traits and further changes in herbicide use that may result 

from such stacks, these potential cumulative impacts are discussed in general terms.

5.2 Agronomic Practices

A determination of nonregulated status of SYHT0H2 soybean is not anticipated to have a 

cumulative effect on agronomic practices involving either cropping practices or weed 

management. As described in Section 4.2.2.1, Cropping Practices, deregulating 

SYHT0H2 soybean would not have a direct or indirect adverse impact on cropping practices, 

though some beneficial changes may result. Transgenic soybean varieties with nonregulated status 

have not differed substantively from nontransgenic soybean in agronomic requirements and pest 

sensitivities, and SYHT0H2 soybean is similar as well (Syngenta, 2012d). It is unlikely that there 

would be any cumulative effect on soybean cropping practices related to growing the plant as a 

result of stacking SYHT0H2 soybean with any other currently available soybean product.

The potential for adverse impacts to the environment from the expected increased use of HPPD 

inhibitor herbicides were they to exist, are direct and indirect impacts outside the scope of this EA.

Authority to regulate the impacts of herbicide use resides with the EPA under FIFRA. USDA’s 

authority comes from the Plant Protection Act, which limits APHIS authority to the regulation of 

plant pests and noxious weeds only. Under APHIS’s regulations, APHIS can only consider plant 

pest risks when making a determination of nonregulated status. APHIS has no authority to 

regulate herbicide use. The EPA’s registration process under FIFRA ensures that pesticides will be 

properly labeled and that, if used in accordance with label specifications, will not cause 

unreasonable harm to humans and the environment. Thus EPA has the authority to regulate the 

effects of herbicide use on humans and the environment. 

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Herbicide use patterns and application rates may change beyond those anticipated in 

Section 4.2.2.4, Pesticide Use. If SYHT0H2 soybean is no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 , 

farmers may apply any of the three herbicides of which SYHT0H2 soybean is tolerant: mesotrione, 

isoxaflutole, and glufosinate. These applications would occur in combination with, or possibly in 

place of, other herbicides registered for use on soybeans. Although HPPD-inhibitor herbicides 

other than mesotrione and isoxaflutole exist, the developer has not demonstrated that SYHT0H2 

soybean has resistance to commercial application rates of other HPPD-inhibitor herbicides 

registered by EPA. It is therefore unlikely that any other currently registered HPPD-inhibiting 

herbicides would be substituted for mesotrione or isoxaflutole for use on SYHT0H2 soybean.

Further, there are no other glutamine synthetase-inhibiting herbicides besides glufosinate (which is 

also known as glufosinate-ammonium and phosphinothricin) that could be used on SYHT0H2 

soybean.

The additional application of mesotrione and also isoxaflutole to rotation crops following 

SYHT0H2 soybean can be estimated. Both are also registered for uses on other crops, and some of 

these crops would also be used in rotation with soybean. The crop with the largest acreage rotation 

with soybean would be corn. Mesotrione (as Callisto for field corn) is registered in 49 states and 

Puerto Rico). Usage rates of mesotrione on corn have increased between 2003 and 2005 to 20% of 

corn acres, but showed a decline in 2010 to 17% (See Table 5-1). The likelihood that mesotrione 

would be used on corn after mesotrione treatment of SYHT0H2 soybean would be the product of 

the estimated adoption rate of SYHT0H2 times percentage of the rotation to corn, and product of 

the present usage rate (17%) which would be 1.7%. However, the rate could be much less, since 

growers are being cautioned by weed scientists not to use the same herbicide site of action (SOA) 

repeatedly or over time (Hartzler, 2014). Isoxaflutole (as Balance Pro for field corn) is registered 

in at least 18 states, and BCS indicates the total has risen to 28 states (Syngenta, 2012d). 

Isoxaflutole use on corn has been much less than that for mesotrione, averaging 7% of acres 

between 2005 and 2012. The rate of successive season reuse by chance alone would be about 

0.7%. Use of two other HPPD inhibitors attained to only 3% of acres on corn, and the repeat rate 

for next year application of mesotrione to SYHT0H2 soybean would be about 0.3%. The 

frequency that any HPPD inhibitor would be used on corn following SYHT0H2 would be no more 

than 2.7 %. Thus, a low likelihood exists of repeated application of the HPPD inhibitor herbicides 

to corn.

Glufosinate use on soybean according to the most recent survey by USDA-NASS has attained to 

3% of acres in 2012 and on corn in 2010 has averaged about 3% of acres over the seven years 

encompassed by the survey. At the maximal predicted adoption rate, the likelihood of glufosinate 

corn following glufosinate SYHT0H2 soybean would be between 0.25 and 0.31%. Again it is 

likely that there would not be a high frequency of repetitive use of the glufosinate which could lead 

to greatly enhanced development of resistance in weeds exposed to and then surviving the 

herbicide.

– 111 –
Table 5-1. Corn and Soybean Acres Treated with Glufosinate, Glyphosate, Isoxaflutole, or

Mesotrione as a Percentage of Acres Planted

Herbicide Corn % 

Acres 

Treated

Soybean % 

Acres 

Treated

Year 2010 2005 2003 2012 2006 2005

Glyphosate 

(all salts)

76 33 19 98 96 91

Glufosinate 2 5 3 3 0 0

Isoxaflutole 7 6 8 0 0 0

Mesotrione 17 20 8 0 0 0

Tembotrione 2 NA NA - - -

Topramezone 1 NA NA - - -

Source: (USDA-NASS, 2013b)

Application of mesotrione to SYHT0H2 soybean can occur under registered use as late as the R1 

stage, and other adjacent crops may also receive incidental application. Corn would be the most 

frequent rotation crop to receive incidental mesotrione applications (and the EA uses rotation crop 

statistics as an estimate of the most likely adjacent crop). Corn, however, is not sensitive to 

mesotrione. Two other crops may follow soybean with a lower frequency (See Table 5-5): 

soybean at 15% (Table 5-4) and wheat at 11% (Table 5-3). Soybean varieties have variable 

sensitivity to HPPD inhibitors, and wheat can receive pyrasulfotole (another HPPD inhibitor 

herbicide) until flag leaf stage. The other crops have a frequency of around 1-2 % or less, or far 

less likely to be an adjacent crop, and so would not represent substantial overall risk of crop injury. 

At least six herbicides classes are typically reported as sources of herbicide injury, and one of these 

classes include the HPPD inhibitor herbicides; glyphosate, and synthetic auxins (such as 2,4-D) are 

also included in the cited classes (Lingenfelter and Curran, 2013). Glyphosate is applied 

exceptionally more frequently to soybean and its rotation crops than other herbicides. While 

glyphosate thus is capable of causing herbicide injury, and may do so, crop injury has not been a 

prominent issue. Glyphosate is also applied at later stages in crop development than other 

herbicides when it is used with glyphosate resistant crops, but it is not cited as particularly prone to 

herbicide drift issues (Lingenfelter and Curran, 2013). Group 4 (WSSA) herbicides (such as 2,4-

D) are more likely to generate alerts for potential drift injuries, but HPPD less so (Lingenfelter and 

Curran, 2013). However, in the absence of observational data, it cannot be determined if 

mesotrione or isoxaflutole when incidentally applied are less safe from causing injuries at a later 

stages to non-MGI soybean or to other crops than at earlier stages. Extension agronomy or weed

science publications generally seem not to note recurrent or frequent non target herbicide injuries 

from applied HPPDs. Instead, injuries are noted to occur to the target crop from incorrect 

herbicide combinations applied with the HPPD class or from known interactions with insecticides 

(Clough and Peachey, NA); some cited injuries were consequences of carryover in the soil from 

the previous season or a same year earlier applications. Correctly following herbicide label 

directions may avert many of these issues (e.g., see Callisto label). 

– 112 –
Table 5-2. Frequency of Crops as a Rotation Crop with Soybean: Crops Registered for Use 

with Mesotrione and Stages for which They are Sensitive.

Crop Permitted exposure Frequency of 

crop as a 

rotation 

following 

soybean (% of 

acres compared 

to soybean)

Use of HPPD 

inhibitor 

herbicides (% 

of acres) in 

2011 or 2012 

NASS Surveys 

(Quick Stat)

Corn Can be used at any POST stage 69 27

Sorghum Seven days pre-emergence 1.1 7

Oats Any stage 0.1 0

Flax Before crop emergence 0.1 0

Millet Before crop emergence .05 0

From: CallistoTM herbicide label and Table 5-5.

Table 5-3. Frequency of Crops as a Rotation Crop with Soybean: Crops Registered for Use 

with Pyrasulfatrole (Huskie) and Stages at which They are Sensitive

Crop Permitted exposure Frequency of 

crop as a 

rotation 

following 

soybean (% of 

acres compared 

to soybean)

Use of HPPD 

inhibitor 

herbicides (% 

of acres) in 

2011 or 2012 

NASS Surveys 

(Quick Stat)

Wheat (spring) First leaf to flag leaf 11.2 0

Barley (spring) First leaf to flag leaf .05 N/A

Durum First leaf to flag leaf N/A 0

Sorghum Between 3 leaf stage of growth

up 30 inches and/or prior to flag 

leaf emergence, whichever 

comes first

1.1 7 (mesotrione)

From: Huskie TM herbicide label

– 113 –
Table 5-4. Crops not Registered for HPPD Inhibitors but with Greater than 14% 

Deployment of a Rotation Crop (by Percentage of Crop to National Crop Total Acres) to 

Soybean

Crop Susceptibility to exposure Frequency of 

crop as a 

rotation 

following 

soybean (% of 

acres compared 

to soybean)

Use of HPPD 

inhibitor 

herbicides (% 

of acres) in 

2011 or 2012 

NASS Surveys 

(Quick Stat)

Soybean No yield loss at 11g/a; 

sensitivity varies by variety

14.5 0

Cotton Susceptible but undefined 2.1 0

Rice At least after 5-6 leaf stage 1.4 0

Sugar Beets Application sensitivity not 

determined: soil sensitive

0.19 0 (no recent 

data)

From: (Young et al., 2003; Damalas et al., 2010) and CallistoTM label 

MGI soybean sites on which mesotrione or isoxaflutole may be applied could potentially be origins 

for HPPD resistant weeds. Some growers whose soybean rotation crops are dependent upon 

mesotrione (or other HPPD inhibiter) for control of weeds could find the potential presence of 

mesotrione- resistant weeds difficult to manage. Other crops that may be planted as rotation crops 

labelled for use of mesotrione include those in Table 5-2 or for use of pyrasulfatrole, those in Table 

5-3. Corn, which has the highest likelihood of being a rotation crop for soybean, already has 

considerable use of HPPD inhibitor herbicides, but has more effective herbicide options already 

than does soybean (K Bradley, Univ. Missouri, personal comment, 2013). Sorghum attains 7% of 

the total soybean crop acreage as a soybean rotation crop, and represents a small likelihood that it 

will be planted adjacent to SYHT0H2 soybean and thus be exposed to escapes of mesotrione 

resistant weeds. The other rotation crops had no major use of HPPD inhibitor herbicides as 

recently as 2011 or 2012. Other soybean rotation crops as listed in Table 5-4 do not already have a 

registered use for an HPPD inhibitor herbicide, so growers are at no risk of losing an important 

herbicide should HPPD inhibitor resistant weeds escape through rotation in subsequent years. 

Increased use of mesotrione with SYHT0H2 adoption is not likely to result in substantive risks of 

mesotrione resistant weeds arising in rotation crops that have no available alternative herbicide for 

their control.

– 114 –
Table 5-5. Crops Planted Following Soybean, with Total Acreage, Percentage of the Crop 

Compared to the National Total Crop Planting (in 2008) and the Percentage of the Crop 

Compared to the Total Soybean Acreage.

Rotational 

Crop Following 

Soybean1

Total 

Acreage of 

Rotational 

Crop 

Following 

Soybean 

(000)2

Percent of 

Rotation 

Crop 

Following 

Soybean3

Percent of 

Rotational 

Crop as a 

Fraction of 

Total 

Soybean 

Acreage4

Corn 51,500 69% 68.6

Soybean 10,866 14% 14.5

Sorghum 841 21% 1.1

Cotton 1,570 42% 2.1

Wheat 8,396 22% 11.2

Barley 41 2% 0.05

Oats 98 5% 0.1

Rice 1,042 45% 1.4

Alfalfa 162 9% 0.2

Sugar Beets 144 17% 0.19

Potatoes 32 10% 0.04

Dry Beans 35 3% 0.05

Dry Peas 38 7% 0.05

Millet 41 16% 0.05

Flax 76 22% 0.1

Various 

vegetables 141 31% 0.2

Sources: See Appendix E; (USDA-NASS, 2008; USDA-NASS, 2009b; Monsanto, 2010; 

Monsanto, 2012b).

Notes:

1. Crops listed have been identified as the primary crops, nationwide, in the soybean rotation strategy.

2. Acres presented represent total acres of rotational crop identified as planted following soybean.

3. Percent of rotation crop following soybean identified as that fraction of the total nationwide planting of 

rotation crop following soybean.

4. Percent of rotation crop following soybean identified as that fraction of total rotation crop relative to total 

acreage of soybean, identified in 2008 as 75,037,000 acres.

– 115 –
It is possible that SYHT0H2 soybean could be stacked with other transgenic soybean varities that 

are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions 

of the Plant Protection Act of 2000 that confer tolerance to herbicides with other modes of action. 

As described in Section 4.2.2.4, Pesticide Use, overall herbicide application rates (as measured in 

pounds of active ingredient applied per acre of crops) have increased slightly in recent years, even 

as particular herbicide application rates have risen or fallen. Stacking SYHT0H2 soybean with 

other traits that confer tolerance to herbicides with different modes of action would offer growers 

greater choices in herbicide programs and advance integrated weed management practices. Any 

herbicides that would be used in this scenario would have been registered with EPA and approved 

for use on soybeans; substantive changes in herbicide application practices are therefore unlikely. 

Agronomic practices would only be minimally altered by using previously approved herbicides on 

SYHT0H2 soybean fields. A determination of nonregulated status of SYHT0H2 soybean would

not have a cumulative effect on agronomic practices.

Weed populations can change in response to farm-level agronomic practices, including weed 

management decisions, as has been seen with the development of glyphosate-resistant weeds as a 

result of the predominant use of glyphosate. An integrated weed management system, incorporating a 

range of herbicides that use different modes of action, could minimize the development of weeds 

resistant to any one herbicide or herbicide class. Further, herbicide use (and indirectly, the use of 

herbicide-tolerant crops) should be a component of a broader integrated weed management system 

(Mortenson et al., 2012). Integrated weed management incorporates a number of practices, including 

the use of cover and rotational crops, tillage, and herbicide applications to reduce selection pressure 

and weed populations in an agricultural environment (Mortenson et al., 2012). Cultivating

SYHT0H2 soybean and using a broader range of herbicides as a result of the Preferred Action 

Alternative will facilitate a more comprehensive approach to weed management than is currently 

possible. See the proposed practice for mesotrione use in Appendix D. Preemptively incorporating

integrated weed management measures (as described in the stewardship plan presented as Appendix

F of the Petition (Syngenta, 2012d) may prevent or delay the development of resistant weed 

populations.

Planted and produced within an integrated weed management system and within the context of best 

management practices, SYHT0H2 soybean would offer soybean growers new herbicide options 

and possibly facilitate the control of glyphosate-resistant weed populations. Additionally, HPPD 

inhibitor-resistant SYHT0H2 may also prevent or delay the rate of development of other herbicide 

resistant weeds. Syngenta-Bayer’s stewardship plan would require signing a Technology Use 

Agreement (TUA) which requires that the grower practice integrated weed management principles 

(Syngenta, 2012). While the details of the TUA have not been finalized, they will describe best 

practice use of SYHT0H2 soybean in terms of several burndown, soil residual application and 

post-emergent applications of residual or foliar active herbicide combinations (Syngenta, 2013). 

The cumulative effect on weed management as a result of determining nonregulated status of

SYHT0H2 soybean could potentially minimize the development of new populations of weed 

species with herbicide resistance and maintain and preserve of herbicide efficacy.

– 116 –
Adoption of MGI soybean could provide growers with an alternative herbicide to glyphosate and 

also an alternative to intensive tillage practices that might be used to manage herbicide resistant 

weeds (Prince et al., 2012a). An additional option for managing weeds and weed resistance in the 

context of multiple crops with various resistance traits can be useful in a framework of integrated 

weed management. However, the eventual occurrence of weeds resistant to mesotrione, 

glufosinate or isoxaflutole will over time limit the use of MGI crops and any benefit to natural 

resources that may arise. The magnitude of the benefit or the loss of the benefit is uncertain 

because decisions on crop production management are made by individual growers.

5.3 Water Quality and Use

A determination of nonregulated status for SYHT0H2 soybean is not anticipated to result in an 

adverse cumulative effect on water quality. As described in Section 4.3.2, Water Quality and Use,

deregulating SYHT0H2 soybean would not have any direct effect or substantive adverse indirect 

effect on water resources. Stacking SYHT0H2 soybean with other herbicide tolerance traits would 

allow other herbicides to be used on SYHT0H2 soybean crops. Any herbicides that would be used in 

this scenario, such as glyphosate, would have already been registered with EPA and approved for use 

on soybeans. Glyphosate, currently the most extensively used herbicide, has relatively low impacts to 

soil and water quality compared to many other herbicides (Cerdeira and Duke, 2010). 

As described in Section 4.3.2, Water Quality, EPA evaluates risks to water quality when 

conducting ecological risk assessments as part of the herbicide registration review process. 

Identified risks are managed by EPA requirements for application methods and buffer zones. 

Based on these precautions, deregulating SYHT0H2 soybean would not have an adverse cumulative 

effect on water quality. In some regions, the inability to control herbicide resistant weeds arising on 

crops and their rotation crops has led to increased tillage or other cultivation. If conventional tillage 

increases to control glyphosate- and other herbicide-resistant weeds, there may be an impact on soil 

quality from increased erosion; a determination of nonregulated status for SYHT0H2 could 

potentially offer an additional means to use herbicides for postemergent weed control on a crop not 

previously capable of exposure to these HPPD inhibitor herbicides. 

5.4 Soil

A determination of nonregulated status of SYHT0H2 soybean is not anticipated to result in an 

adverse cumulative impact on soil quality. As described in Section 4.3.1, Soil, SYHT0H2 soybean 

would not have a direct or indirect adverse effect on soil quality. SYHT0H2 soybean will 

contribute to the continued trend toward conservation tillage, an agricultural practice with strong 

direct and positive effects on soil quality (Holland, 2004; NRC, 2010). Stacking 

SYHT0H2 soybean with other transgenic traits that confer herbicide tolerance may have a positive 

effect on this trend. Increasing the range of herbicide products that may be used on 

SYHT0H2 soybean as part of an integrated weed management program could allow further use of 

conservation tillage.

– 117 –
Stacking SYHT0H2 soybean with other herbicide tolerance traits would allow additional

herbicides to be used on SYHT0H2 soybean crops. Any herbicides that would be used in this 

scenario would have already been registered with EPA and approved for use on soybeans. Soil 

quality would not expected to be altered by using previously approved herbicides on 

SYHT0H2 soybean fields. A determination of nonregulated status of SYHT0H2 soybean would 

not have a cumulative adverse effect on soil.

5.5 Air Quality

A determination of nonregulated status for SYHT0H2 soybean is not anticipated to result in an 

adverse cumulative effect on air quality. As described in Section 4.3.3, Air Quality, deregulating 

SYHT0H2 soybean would not have any direct or indirect adverse effect on air quality. Stacking 

SYHT0H2 soybean with other herbicide tolerance traits would allow additional herbicides to be used 

on SYHT0H2 soybean crops. Any other herbicides that would be used in this scenario would have 

already been registered with EPA and approved for use on soybeans. Air quality would not be 

adversely affected by using other previously approved herbicides on SYHT0H2 soybean fields. Air 

quality could benefit from increased use of conservation tillage practices, decreasing dust emissions. 

A determination of nonregulated status of SYHT0H2 soybean would not have a cumulative adverse

effect on air quality.

5.6 Plants

A determination of nonregulated status of SYHT0H2 soybean is not anticipated to result in an

adverse cumulative effect on non-target plants. As discussed in Section 4.4.2, Plants,

SYHT0H2 soybean would not directly impact non-target plants but could indirectly affect them

through changes in herbicide use. The herbicides that would be newly available for use on soybeans 

are toxic to target plants (weeds) and some non-target plants; these characteristics generally apply to 

all herbicides. Stacking SYHT0H2 soybean with other herbicide tolerance traits could allow other 

herbicides to be used on SYHT0H2 soybean crops at lower application rates than under the currently 

dominant glyphosate use. Any herbicides that would be used in this scenario would have already 

been registered with EPA and approved for use on soybeans. EPA conducts an in-depth analysis of 

the potential impacts of pesticides to non-target plants based upon an extensive data set, and sets 

restrictions to ensure there is no unreasonable harm to non-target plants. When the herbicides are 

used in accordance with label requirements, non-target plants would therefore be unaffected by using 

previously approved herbicides, such as glyphosate, on SYHT0H2 soybean fields. A determination 

of nonregulated status of SYHT0H2 soybean would not have a cumulative adverse effect on nontarget plants.

Soybean crops on which mesotrione or isoxaflutole may be applied could potentially be sites for 

development of HPPD resistant weeds. Growers whose soybean rotation crops (See Table W) are 

dependent upon mesotrione (or other HPPD inhibiter) for control of weeds might find the potential 

presence of mesotrione- resistant weeds difficult to control. Other crops that may be planted as 

rotation crops labelled for use with mesotrione include those in Table Y or with Isoxaflutole in 

Table Z. Corn, which has the highest likelihood of being a rotation crop for soybean, already has 

considerable use of HPPD inhibitor herbicides. Sorghum attains 7% of the soybean crop acreage 

– 118 –
as a rotation crop, and represents a small likelihood that it will be a rotation crop for SYHT0H2 

soybean and thus be exposed to escapes of mesotrione resistant weeds. The other crops have no 

major use of HPPD inhibitor herbicides as recently as 2011 or 2012. Other rotation crops as listed 

in Table ZZ do not already have a registered use of an HPPD inhibitor herbicide, so are at no risk 

of losing an important herbicide should mesotrione weeds escape through rotation in subsequent 

years. Increased use of mesotrione will not result in substantive risks of mesotrione resistant weeds 

that have no major alternative herbicides for their control in rotation crops.

Potential for Weed Cross-Resistance to other HPPD Inhibitor herbicides. At least four HPPD 

inibitors have been available on the market for weed control in corn. These are a newer class of 

herbicides, mesotrione (Callisto), having been released in 2001, and others such as tembotrione 

(Laudis) in 2006 pyrasulfutole (Huskie for small grains) in 2008 and topramezone (Impact) in 

2008. Despite recent market availability, resistance to this class nevertheless has been detected in 

four US states, but thus far only in two weed species. Heap (2013) reports Palmer amaranth in 

Kansas has resistance to three herbicide MOAs, and these include three HPPD inhibitors, 

mesotrione, tembotrione and topramezone; common waterhemp in Illinois has resistance to the 

same three HPPD inhibitors. The multiple HPPD resistances attain 10-35X resistance compared to 

susceptible common waterhemp populations (Hausman et al., 2011). Thus, although mechanisms 

of weed resistance may be common to all those weed populations against HPPD inhibitor 

herbicides, the weeds in which herbicide resistance has been described are two that have already 

developed resistance to many other herbicides as well. Also, the frequency of use on corn in 2010 

was limited to 27% of corn acreage for all herbicides of the class (Figure 5-1), indicating frequent 

use, but resistance developed only in those two weeds with an already high proclivity for resistance 

to several other herbicides.

As described in Section 4.3.2, Water Quality, EPA evaluates risks to water quality when 

conducting ecological risk assessments as part of the herbicide registration review process. 

Identified risks are managed by EPA requirements for application methods and buffer zones. 

Based on these precautions, deregulating SYHT0H2 soybean would not have an adverse cumulative 

effect on water quality. In some regions, the inability to control herbicide resistant weeds arising on 

crops and their rotation crops has led to increased tillage or other cultivation. If conventional tillage 

increases to control glyphosate- and other herbicide-resistant weeds, there may be an impact on soil 

quality from increased erosion; nonregulated status for SYHT0H2 could potentially offer an 

additional means to use herbicides for postemergent weed control on a crop not previously capable of 

exposure to these HPPD inhibitor herbicides. 

Although a small percentage of soybean fields may be subject to repeated use of mesotrione or 

isoxaflutole from previous application of one of these to corn (see estimates in Environmental 

Consequences section), APHIS expects that farmers will use discretion in how frequently the same 

herbicides or same SOAs are repeatedly used on-farm when SYHT0H2 is commercially available. 

For example soybean crop consultants indicated in a survey valued as important at least seven best 

– 119 –
management practices40 (score of 4.5 of 5.0) to manage and prevent herbicide resistant weeds (Riar 

et al., 2013) and 60% of the time perceived that growers actually used the top five41 of these 

BMPs. Another larger survey of certified crop advisers in 2012 who were also producers indicated 

that in the North Central States, 57% believed that the next ‘silver bullet’ for managing weeds 

would come from new management strategies rather than new chemicals or soybean traits(Asmus 

et al., 2013). Multistate grower surveys from 2010 also indicate that growers were increasingly 

using practices important for weed resistance compared to previous surveys conducted in 2005: 

54% of growers were using multiple herbicide SOA chemistries and application of residual 

chemicals and that 75% of those with on-farm resistant weeds were using residuals (Prince et al., 

2012b). Other best management practices such as field scouting before and after herbicide 

application were being used by all those participating up to 65% of the time. From these surveys, 

APHIS concludes that growers are likely to be much more cautious about using herbicide practices 

that will avert new resistance development. Following increasingly frequent negative 

consequences on income, grower reliance on a single herbicide with limited applications as was 

typical practiced with glyphosate resistant crops is unlikely to continue. Nonregulated status will 

facilitate the evolving of additional strategies and use of additional herbicide SOAs that can be 

used to deter resistance and deal with existing herbicide resistant weeds.

The lack of new herbicide chemistries for weed control in soybean has resulted in repeating an 

approach to weed control that was deployed in glyphosate resistant crops. The strategy has been 

modified several times using older herbicides that have proven effectiveness and that have been 

shown to encourage limited development of weed resistance (Johnson et al., 2012). The usefulness 

of a new option will be gained by growers with the commercial availability of the other herbicide 

resistant crops, such as SYHT0H2, and these include (Johnson et al., 2012):

a. reduction of crop injury associated with use of the herbicide on non-resistant crops

b. control of resistant weeds with a different chemistry

c. continuation of conservation tillage to obviate full tillage for weed control

d. help in avoiding further selection of glyphosate resistant weeds, even though glyphosate 

as a successful herbicide will continue to an have important role in many weed control 

programs

As noted by extension weed specialists (Steckel, L, 2013 and Young, B., 2013, petition comments, 

Docket APHIS-2012-0090) the need for diversity of weed management options is increasing, 

perhaps more so in soybean for post emergent herbicides than for other crops such as corn (Kevin 

Bradley, Univ. Missouri, personal communication, 2013).

The availability of a new herbicide resistant crop is not a final solution for control of difficult or 

resistant weeds. The history of herbicide usage on non-resistant crops is also one which includes 

development of weed resistance and the necessity of integrating a variety of measures to avert and 

40 Proper herbicide timing. Start clean (no weeds at planting). Apply multiple effective herbicide modes of 

action targeting most problematic weeds. Use of full labeled herbicide rates. Prevent in-crop weed 

seed production. Crop rotation. Rotate herbicide-resistant traits.

41 Proper herbicide timing. Start clean (no weeds at planting). Apply multiple effective herbicide modes of 

action targeting most problematic weeds. Use of full labeled herbicide rates.

– 120 –
remediate such weeds. An important issue is whether the users of herbicide technology properly 

perceive the developing problems and respond opportunely and appropriately to them. The 

necessity for proper management practices that forestall development of resistant weeds as noted 

earlier is increasingly perceived by growers and by crop advisors, extension staff, and technology 

developers. Advice from state Extension services, and from state extension agents has become 

clear in defining the hazards to growers of failure to use weed management BMPs42. APHIS 

concludes that the lessons provided in the increasing populations of weeds resistant to herbicide 

because of inattention to best management practices, and those provided by the financial losses

from not correctly averting resistant weed development will shape future responses of growers to 

follow their own best interest, and embrace a culture of applying effective BMPs.

Mesotrione resistant waterhemp developed in Nebraska by 2011 on seed corn production acres, 

and that occurred after five seasons of repetitive use of mesotrione (Knezevic, 2011). Similarly, 

another population in Illinois after six sequential seasonal applications of multiple HPPD inhibitors

once or twice per season, also became resistant to mesotrione (Hausman et al., 2011). Knowing 

that such resistance is always a present potentiality argues for the use of herbicide technology only 

when accompanied by due diligence and the avoidance of any such obvious misuse. Careful 

planning for both prominent and resistant weed suppression by specific combinations of herbicides 

and availability and use of all options will facilitate effective control and suppress resistance 

development. SYHT0H2 can provide a finite number of years of useful weed control when this

technology is integrated into a comprehensive and integrated plan for management of weeds.

5.7 Soil Microorganisms

A determination of nonregulated status of SYHT0H2 soybean is not anticipated to result in an 

adverse cumulative effect on soil microorganisms. As described in Section 4.4.3, Soil 

Microorganisms, deregulating SYHT0H2 soybean would not have a direct or indirect adverse 

impact on soil microorganisms. Other APHIS-approved transgenic traits potentially stacked with 

SYHT0H2 soybean do not adversely impact soil microorganisms. Stacking SYHT0H2 soybean 

with other transgenic traits, including those conferring herbicide tolerance, would not adversely 

impact soil microorganisms. All herbicides that would be used on a stacked product would have 

been subject to EPA’s registration and review process for impacts to human health and the 

environment. No overall impact of the suite of potential herbicides is expected on soil 

microorganisms. A determination of nonregulated status of SYHT0H2 soybean would not have a 

cumulative adverse effect on soil microorganisms.

42 For example, “Single pest management techniques no longer are considered reliable to combat most 

pests. Many management practices have limited periods of effectiveness, while others can create 

side effects worse than the crop damage. Success in managing crop pests depends on how well 

economically effective technologies, old and new, can be integrated, while minimizing risk to 

health and the environment... Simplistic approaches such as routine applications of pesticides are 

no longer acceptable pest management practices... Using a combination of methods is the best 

approach to handling most pest problems.” Penn-State-University, Pest Management. 2014).

– 121 –
5.8 Biodiversity

A determination of nonregulated status of SYHT0H2 soybean is not anticipated to result in an

adverse cumulative effect on biodiversity. Cultivating SYHT0H2 soybean is unlikely to directly or 

indirectly impact biodiversity, as described in Section 4.4.4, Biodiversity. Stacking 

SYHT0H2 soybean with other transgenic traits, including those conferring herbicide tolerance, 

could facilitate the use of alternative herbicides and more targeted choices for weed control in 

soybean fields. A determination of nonregulated status of SYHT0H2 soybean would not have a 

cumulative adverse effect on biodiversity.

Using transgenic soybean varieties containing herbicide-tolerance traits may improve biological 

diversity by facilitating the use of conservation tillage practices (NRC, 2010; Bonny, 2011a), 

which, in turn, can improve soil porosity, enhance soil fauna and flora, increase the flexibility of 

crop rotation, and facilitate strip cropping (Fernandez-Cornejo et al., 2002). Each of these 

contributes to the health of the faunal and floral communities in and around soybean fields, thereby 

promoting biodiversity (Palmer et al., undated).

5.9 Domestic Trade Environment

A determination of nonregulated status of SYHT0H2 soybean is not anticipated to result in an

adverse cumulative effect on the domestic trade environment. As described in Section 4.6.1, 

Domestic Trade Environment, deregulating SYHT0H2 soybean would not have a direct or indirect 

adverse impact on the domestic trade environment. Domestically produced soybean and soybean 

products, whether transgenic or not, are produced for a number of markets. Transgenic soybean 

products comprise 93 percent of the soybean market, and the addition of a stacked 

SYHT0H2 soybean product is unlikely to substantively affect the market of transgenic products. 

Market use of soybean is often dependent on the soybean variety, and the resulting nutrient 

composition. There are compositional differences among some soybean varieties grown for animal 

feed and those for human consumption. These include the soybean varieties that are intentionally 

produced to yield a variety of fatty acid profiles (e.g., for food uses). They may include soybeans 

that have been produced through standard breeding or genetic engineering methods. Market use of 

SYHT0H2 soybean stacked with other transgenic traits would likely be similar to that of other 

soybean products currently on the market. This approach would likely have a minor beneficial 

impact on the domestic trade market as a result of increased competition. A determination of 

nonregulated status of SYHT0H2 soybean would not have an adverse cumulative effect on the 

domestic trade environment.

– 122 –
6 THREATENED AND ENDANGERED SPECIES 

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching wildlife 

conservation laws ever enacted by any nation. Congress passed the ESA to prevent extinctions 

facing many species of fish, wildlife and plants. The purpose of the ESA is to conserve 

endangered and threatened species and the ecosystems on which they depend as key components 

of America’s heritage. To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works 

in cooperation with the National Marine Fisheries Service (NMFS), other Federal, State, and local 

agencies, Tribes, non-governmental organizations, and private citizens. Before a plant or animal 

species can receive the protection provided by the ESA, it must first be added to the Federal list of 

threatened and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be endangered or 

threatened because of any of the following factors:

• The present or threatened destruction, modification, or curtailment of its habitat or 

range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• The inadequacy of existing regulatory mechanisms; and

• The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, 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 designated critical habitat. To facilitate their ESA 

consultation requirements, APHIS met with the USFWS from 1999 to 2003 to discuss factors 

relevant to APHIS’ regulatory authority and effects analysis for petitions for nonregulated status 

and developed a process for conducting an effects determination consistent with the Plant 

Protection Act (PPA) of 2000 (Title IV of Public Law 106-224). APHIS uses this process 

to help fulfill its obligations and responsibilities under Section 7 of the ESA for 

biotechnology regulatory actions. 

APHIS met with USFWS officials on June 15, 2011, to discuss whether APHIS has any 

obligations under the ESA regarding analyzing the effects of herbicide use associated with all 

GE crops on TES. As a result of these joint discussions, USFWS and APHIS have agreed that it 

is not necessary or appropriate for APHIS to perform an ESA effects analysis on herbicide use 

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associated with GE crops currently planted because EPA has both regulatory authority over the 

labeling of pesticides and the necessary technical expertise to assess pesticide effects on the 

environment under FIFRA. APHIS has no statutory authority to authorize or regulate the use of 

mesotrione, isoxaflutole, glufosinate, or any other herbicide, by soybean growers. Under 

APHIS’ current Part 340 regulations, APHIS only has the authority to regulate SYHT0H2 

soybean or any GE organism as long as APHIS believes they may pose a plant pest risk (7 CFR 

§ 340.1). APHIS has no regulatory jurisdiction over any other risks associated with GE 

organisms including risks resulting from the use of herbicides or other pesticides on those 

organisms. 

After completing a plant pest risk analysis, if APHIS determines that SYHT0H2 soybean seeds, 

plants, or parts thereof do not pose a plant pest risk, then these articles would no longer be 

subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR Part 

340, and therefore, APHIS must reach a determination that these articles are no longer 

regulated. As part of its EA analysis, APHIS is analyzing the potential effects of SYHT0H2 

soybean on the environment including, as required by the ESA, any potential effects to 

threatened and endangered species and critical habitat. As part of this process, APHIS 

thoroughly reviews the GE product information and data related to the organism (generally a 

plant species, but may also be other genetically engineered organisms). For each 

transgene/transgenic plant, APHIS considers the following: 

• A review of the biology and taxonomy 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 impacts;

• 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 species (TES) of plants or a host of any TES; and

• Any other information that may inform the potential for an organism to pose a plant 

pest risk.

In following this review process, APHIS, as described below, has evaluated the potential effects 

that a determination of nonregulated status of SYHT0H2 soybean may have, if any, on 

federally-listed TES 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 identified in the Affected Environment section of the EA, APHIS reviewed the USFWS 

list of TES species (listed and proposed) for each state where soybean is commercially produced 

from the USFWS Environmental Conservation Online System (USFWS, 2014a; USFWS, 

2014b).

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Prior to this review, APHIS considered the potential for SYHT0H2 soybean to extend the range 

of soybean production and also the potential to extend agricultural production into new natural 

areas. APHIS has determined that agronomic characteristics and cultivation practices required 

for SYHT0H2 soybean are essentially indistinguishable from practices used to grow other 

soybean varieties, including other herbicide-tolerant varieties (USDA-APHIS, 2014b) (Syngenta 

and Bayer, 2012b; Syngenta and Bayer, 2013). Although SYHT0H2 soybean may be expected 

to replace other varieties of soybean currently cultivated, APHIS does not expect the cultivation 

of these to result in new soybean acres to be planted in areas that are not already devoted to 

agriculture. Accordingly, the issues discussed herein focus on the potential environmental 

consequences of the determination of nonregulated status of SYHT0H2 soybean on TES species 

in the areas where soybean are currently grown.

For its analysis on TES plants and critical habitat, APHIS focused on the agronomic differences 

between the regulated articles and soybean varieties currently grown; the potential for increased 

weediness; and the potential for gene movement to native plants, listed species, and species 

proposed for listing. 

For its analysis of effects on TES animals, APHIS focused on the implications of exposure to 

the novel proteins expressed in the plants as a result of the transformation, and the ability of the 

plants to serve as a host for a TES. The novel proteins associated with SYHT0H2 soybean are 

listed in Table 6-1.

Table 6.1. GE Proteins in SYHT0H2 soybean

Regulated Article Protein Phenotypic Effects

SYHT0H2 Soybean p-hydroxyphenylpyruvate 

dioxygenase (AvHPPD-3)

Resistance to the HPPDinhibiting herbicides, such as 

mesotrione and isoxaflutole

phosphinothricin 

acetyltransferase (PAT)

Resistance to glufosinate

6.1 Potential Effects of SYHT0H2 Soybean on Threatened or 

Endangered Species

6.1.1 Threatened and Endangered Plant Species and Critical Habitat

Soybean has been cultivated around the globe without any report that it is a serious weed or that 

it forms persistent feral populations (USDA-APHIS, 2012). Soybean does not possess any of the 

attributes commonly associated with weeds (Baker, 1965), such as long persistence of seed in the 

soil, the ability to disperse, invade, and become a dominant species in new or diverse landscapes, 

or the ability to compete well with native vegetation. Furthermore, mature soybean seeds have 

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no innate dormancy; germinating seedlings and plants are sensitive to cold, are not expected to 

survive in freezing winter conditions and do not vegetatively reproduce (OECD, 2000b); (Raper 

Jr. and Kramer, 1987). Soybeans that volunteer from the previous year’s crop are rarely a 

management issue, as crop losses attributable to interference from soybean volunteers are 

minimal (Owen and Zelaya, 2005). However, volunteers can be a problem particularly in the 

South where winters are milder, and particularly if weather events lead to soybean seed loss prior 

to harvest (York et al., 2005).

Agronomic data provided in the Petition were used in the analysis of weediness potential for 

SYHT0H2 soybean and further evaluated for the potential to impact threatened or endangered 

species. Agronomic studies tested the hypothesis that the weediness potential of 

SYHT0H2 soybean is unchanged with respect to conventional soybean. No differences were 

detected between SYHT0H2 soybean and conventional soybean in growth, reproduction or 

interactions with pests and disease, other than the intended effect of herbicide tolerance (Syngenta 

and Bayer, 2012b); (Syngenta and Bayer, 2013). This herbicide tolerance resulting from presence 

of the AvHPPD-3 and PAT proteins would not contribute to increased weediness. If volunteers 

appear in subsequent crops there are effective weed management strategies to control them

(OECD, 2000b; York et al., 2005). Based on the agronomic field data and a literature survey on 

soybean weediness potential, SYHT0H2 soybean is unlikely to affect threatened or endangered 

species or their habitat as a troublesome or invasive weed.

APHIS evaluated the potential of SYHT0H2 soybean to cross with wild relatives, listed species, 

and species proposed for listing. As previously discussed in the analysis of Gene Movement in 

the Natural Environment, APHIS has determined that there is no risk to unrelated plant species 

from the cultivation of SYHT0H2 soybean. Soybean is highly self-pollinating and can only 

cross with other members of Glycine subgenus Soja (OECD, 2000b). Wild soybean species are 

endemic in China, Korea, Japan, Taiwan and the former USSR; in the U.S. there are no Glycine

species found outside of cultivation and the potential for outcrossing is nil (OECD, 2000b). 

After reviewing the list of threatened and endangered plant species in the U.S. states where 

soybean is grown, APHIS determined that SYHT0H2 soybean would not be sexually compatible 

with any listed threatened or endangered plant species proposed for listing, as none of these 

listed plants are in the same genus nor are known to cross pollinate with species of the genus 

Glycine (USFWS, 2014a; USFWS, 2014b).

Based on agronomic field data, literature surveyed on soybean weediness potential, and no 

sexually compatibility of TES with soybean, APHIS has concluded that SYHT0H2 soybean will 

have no effect on threatened or endangered plant species or on critical habitat.

6.1.2 Threatened and Endangered Animal Species

Threatened and endangered animal species that may be exposed to the gene products in 

SYHT0H2 soybean would be those TES that inhabit soybean fields and feed on SYHT0H2

soybean. To identify potential effects on threatened and endangered animal species, APHIS 

evaluated the risks from consuming SYHT0H2 soybean. 

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Soybean commonly is used as a feed for many livestock. Additionally, wildlife may use 

soybean fields as a food source, consuming the plant or insects that live on the plants, although, 

TES generally are found outside of agricultural fields. Few if any TES are likely to use soybean 

fields because they do not provide suitable habitat. Only whooping crane (Grus americana), 

sandhill crane (Grus canadensis pulla), piping plover (Charadrius melodus), interior least tern 

(Sterna antillarum), and Sprague’s pipit (Anthus spragueii; a candidate species) occasionally 

feed in farmed sites (US Fish and Wildlife Service, 2011). These bird species may visit soybean 

fields during migratory periods, but would not be present during normal farming operations 

(Krapu et al., 2004a; US Fish and Wildlife Service, 2011). In a study of soybean consumption 

by wildlife in Nebraska, results indicated that soybeans do not provide the high energy food 

source needed by cranes and waterfowl (Krapu et al., 2004a). Least terns feed over water, 

principally on small fish, but also eat aquatic insects (Thompson, 1997). Piping plover also feed 

entirely on invertebrates (Haig, 2004). None of the listed species are likely to feed on soybean 

plants or seeds.

The Delmarva fox squirrel (Sciurus niger cinereus), which inhabits mature forests of mixed 

hardwoods and pines, may be found adjacent to agricultural areas of the Delmarva Peninsula (US 

Fish and Wildlife Service, 2008). The squirrel forages for food in woodlots and openings, such 

as farm fields, with a diet that mainly includes acorns, nuts/seeds of hickory, beech, walnut, and 

loblolly pine. They also feed on tree buds and flowers, fungi, insects, fruit, and seeds in the 

spring and mature, green pine cones in the summer and early fall (US Fish and Wildlife Service, 

2008). The Louisiana black bear (Ursus americanus luteolus), occurring in Louisiana, 

Mississippi, and Texas, may occasionally forage on soybean; however, other crops such as corn, 

sugarcane, and winter wheat are preferred by the species (MSU, No Date).

APHIS has examined data on the food and feed safety of SYHT0H2 soybean, evaluating the 

agronomic and morphological characteristics, including compositional and nutritional 

characteristics, safety evaluations and toxicity tests, as compared to a conventional hybrid 

soybean variety grown at eight different sites across the U.S. in 2010 (Syngenta and Bayer, 

2012b; Syngenta and Bayer, 2013). The analysis included moisture, protein, fat, ash, 

carbohydrates, amino acids, fatty acids, fibers, anti-nutrients, vitamin E isoforms, minerals and 

vitamins, consistent with OECD guidelines (OECD, 2001b) (Syngenta and Bayer, 2012a). 

SYHT0H2 soybeans had significantly lower (2.7%) potassium (K) and iron (Fe) content (3.5%) 

than the comparator Jack variety, but not significantly different from the reference varieties used 

in this study or from the International Life Sciences Institute’ (ILSI) crop composition database 

(Syngenta and Bayer, 2012a). The other compositional and nutritional components described 

above were not significantly different between SYHT0H2 soybeans and the conventional nontransformed soybean control Jack (Syngenta and Bayer, 2012a). 

The potential allergenicity and toxicity of the introduced AvHPPD-03 and PAT proteins 

(obtained from Avena sativa and Streptomyces viridochromogenes, respectively) was assessed, 

according to the recommendations of the Codex Alimentarius Commission (Codex, 2003). 

For the toxicity analysis, the AvHPPD-03 amino acid sequence was systematically compared 

with the latest posting of the NCBI Entrez Protein Database (NCBI, 2012). The NCBI Entrez 

Protein Database search identified 1,394 sequences with significant similarity to the AvHPPD-03 

amino acid sequence (E < 0.4). None of these sequences corresponded to known or putative 

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toxins (Syngenta and Bayer, 2012a). HPPD proteins are ubiquitous in plants, animals and 

microbes, and are not novel (Syngenta and Bayer, 2012a). Standard studies in mice exposed to 

high doses of AvHPPD-03 or PAT demonstrated no toxic effects. The AvHPPD-03 protein is 

99.7 percent identical to the native HPPD enzyme from oat (Avena sativa) and there is no reason to 

suspect it would present a risk to non-target organisms (Syngenta and Bayer, 2012a). Data 

regarding the environmental safety of PAT proteins have been extensively reviewed in 

international scientific, peer-reviewed journals (Herouet et al., 2005). The PAT protein is 

expressed in a number of GM crops that have been approved by regulatory agencies (USDAAPHIS, 2014a) (Syngenta and Bayer, 2012a). These GM crops have been consumed by humans 

and animals since 1995 and have exhibited no significant adverse effects. In addition, the EPA 

has exempted the PAT enzyme and the genetic material necessary for its production in all raw 

agricultural commodities (40 CFR Part 180, 1997), (40 CFR Part 180.1151, 2005). 

To assess allergenicity potential, the AvHPPD-03 protein and the PAT protein were compared 

with listings in the FARRP Allergen Protein Database (FARRP, 2012). The AvHPPD-03 protein 

from SYHT0H2 soybean, differs from native oat (A. sativa) HPPD amino acid sequence by a 

single amino acid residue that is not part of the enzyme’s active site. Oat contains no 

endogenous proteins that are listed in the FARRP Allergen Protein Database (FARRP 2012) and 

therefore is not considered to be a known allergenic food. Two different bioinformatic 

comparison searches were performed for the AvHPPD-03 and PAT proteins against the FARRP 

Allergen Protein Database. Neither search found a significant level of shared amino acid 

sequence between AvHPPD-03 or PAT and any entry in the FARRP Allergen Protein Database 

(Syngenta and Bayer, 2012a). An evaluation of the susceptibility of AvHPPD-03 and PAT 

proteins to degradation in simulated mammalian gastric fluid containing pepsin and in simulated 

mammalian intestinal fluid containing pancreatin. Results indicated that the PAT protein was 

completely digested in both SGF and SIF within 0.5 minute, and the AvHPPD-03 in one minute 

(both the first time point sampled), indicating that PAT and AvHPPD-03 are rapidly and 

completely degraded by pepsin under mammalian gastric conditions and by pancreatin under 

simulated mammalian intestinal conditions (Syngenta and Bayer, 2012a). These studies and 

reviews support the conclusion that AvHPPD-03 and PAT proteins are unlikely to be food 

allergens.

In addition to establishing that AvHPPD-03 and PAT are nontoxic and not allergenic, studies 

comparing SYHT0H2 soybean to its nontransgenic counterpart demonstrated no meaningful 

differences in agronomic or morphological characteristics (Syngenta and Bayer, 2012a). 

Compositional elements, including proximate and fiber components, vitamins, amino acid and 

fatty acid content, and antinutrients and isoflavone concentrations, revealed no substantive 

differences between SYHT0H2 soybean and conventional soybean varieties (Syngenta and Bayer, 

2012a). These data indicate there is no substantial difference in the composition and nutritional 

quality of SYHT0H2 soybean compared with conventional soybean varieties, apart from the 

presence of the AvHPPD-03 and PAT proteins. These results show that the incorporation of the 

avhppd-03 and pat transgenes and the accompanying activity of the AvHPPD-03 and PAT proteins 

in SYHT0H2 soybean do not result in any biologically meaningful differences between 

SYHT0H2 soybean and non-genetically engineered varieties.

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APHIS considered the possibility that SYHT0H2 soybean could serve a host plant for a 

threatened or endangered species. A review of the species list reveals that there are none that 

would use soybean as a host plant.

Considering the compositional and agronomic similarities between SYHT0H2 soybean and 

other varieties currently grown and the lack of toxicity and allergenicity of the AvHPPD-03 and 

PAT proteins, APHIS has concluded that exposure and consumption of SYHT0H2 soybean

would have no effect on threatened or endangered animal species.

6.2 Conclusion

After reviewing the possible effects of allowing the environmental release of SYHT0H2

soybean, APHIS has not identified any stressor that could affect the reproduction, numbers, or 

distribution of a listed TES or species proposed for listing. APHIS also considered the potential 

effect of a determination of nonregulated status of SYHT0H2 soybean on designated critical 

habitat or habitat proposed for designation, and could identify no differences from effects that 

would occur from the production of other soybean varieties. Soybean is not considered a 

particularly competitive plant species and has been selected for domestication and cultivation 

under conditions not normally found in natural settings. Soybean is not sexually compatible 

with, or serves as a host species for, any listed species or species proposed for listing. 

Consumption of SYHT0H2 soybean by any listed species or species proposed for listing will not 

result in a toxic or allergic reaction. Based on these factors, APHIS has concluded that a 

determination of nonregulated status of SYHT0H2 soybean, and the corresponding 

environmental release of this soybean variety will have no effect on listed species or species 

proposed for listing, and would not affect designated habitat or habitat proposed for designation. 

Because of this no-effect determination, consultation under Section 7(a)(2) of the Act or the 

concurrences of the USFWS or NMFS is not required.

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7 CONSIDERATION OF EXECUTIVE ORDERS, 

STANDARDS, AND TREATIES RELATING TO 

ENVIRONMENTAL IMPACTS

As required by the CEQ, this Chapter considers the Executive Orders (EOs), standards, and treaties 

related to the potential environmental impacts of the Preferred Alternative.

7.1 Executive Orders with Domestic Implications

Four EOs have domestic implications that are relevant to the environmental assessment of the 

petition to determine nonregulated status for SYHT0H2 soybean.

7.1.1 Executive Order 12898: Environmental Justice

EO 12898, Federal Actions to Address Environmental Justice in Minority Populations and 

Low-Income Populations43, 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 or low-income communities from being subjected to 

disproportionately high and adverse human health or environmental effects.

SYHT0H2 soybean is not significantly different from other transgenic or nontransgenic soybean. 

As described in Chapter 4, Section 4.4.1, Animals, the AvHPPD-03 and PAT enzymes do not pose 

a hazard to humans. A voluntary FDA consultation for food and feed use of SYHT0H2 soybean

has been initiated by the Petitioners. Data and information provided by the Petitioners support the 

safe use of SYHT0H2 soybean and indicate that it will be as nutritious and wholesome as other 

soybean currently used as food and feed. Based on these analyses, SYHT0H2 soybean is not 

expected to have a disproportionate adverse effect on minorities or low-income populations.

As described in Chapter 4, Section 4.2.2, Agronomic Practices, the cultivation of previously 

soybean varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the 

plant pest provisions of the Plant Protection Act of 2000 with other herbicide tolerance traits has 

changed herbicide application patterns and rates. If herbicide applications are reduced or less toxic 

herbicides are used, there may be a beneficial effect on minority populations. Any effect would be 

negligible, assuming that the herbicides are used in accordance with label precautions. These 

populations might include farm workers and their families, and other rural dwelling individuals 

who are potentially exposed to herbicides through aerial application, groundwater, or other routes 

of exposure.

43 EO 12898 of February 11, 1994; 59 FR 7629.

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7.1.2 Executive Order 13045: Protection of Children

EO 13045, Protection of Children from Environmental Health Risks and Safety Risks44,

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. This EO requires each federal agency (to the extent permitted by law and 

consistent with the agency’s mission) to identify, assess, and address environmental health risks 

and safety risks that may disproportionately affect children.

SYHT0H2 soybean is not significantly different from other transgenic or nontransgenic soybean. 

As described in Chapter 4, Section 4.4.1, Animals, the AvHPPD-03 and PAT enzymes do not pose 

a hazard to humans. A voluntary FDA consultation for food and feed use of SYHT0H2 soybean

has been initiated by the Petitioners. Data and information provided by the Petitioners support the 

safe use of SYHT0H2 soybean and indicate that it will be as nutritious and wholesome as other 

soybean currently used as food and feed. Based on these analyses, SYHT0H2 soybean is not 

expected to have a disproportionate adverse effect on children.

As described in Chapter 4, Section 4.2.2, Agronomic Practices, the cultivation of soybean varieties 

that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest 

provisions of the Plant Protection Act of 2000 with other herbicide tolerance traits has changed

herbicide application patterns and rates. If herbicide applications are reduced or less toxic 

herbicides are used, there may be a beneficial effect on children that might be exposed to the 

chemicals. Any effect would be negligible, assuming that the herbicides are used in accordance 

with label precautions. Similar to minority populations, these children might include families of 

farm workers and other rural dwelling individuals who are exposed to herbicide through aerial 

application, groundwater contamination, or other routes.

7.1.3 Executive Order 13112: Invasive Species

EO 13112, Invasive Species 45, requires federal agencies to 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.

Soybean is a highly domesticated plant and is not an invasive species. Both nontransgenic and 

transgenic soybean varieties that have been determined as non-regulated are widely grown in the 

US and have not developed weedy or invasive characteristics. As described in Section 4.4.5, Gene 

Movement in the Natural Environment, SYHT0H2 soybean plants are very similar in agronomic 

characteristics to other soybean varieties that are currently grown and are not expected to become 

weedy or invasive, and are not toxic to listed species. Accordingly, the Preferred Alternative would 

not raise concerns addressed by EO 13112, Invasive Species.

44 EO 13045 of April 21, 1997; 62 FR 19885.

45 EO 13112 of February 3, 1999; 64 FR 6183.

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7.1.4 Executive Order 13186: Migratory Birds

EO 13186, Responsibilities of Federal Agencies to Protect Migratory Birds46, requires each federal 

agency to avoid and minimize, to the extent practicable, adverse impacts on migratory bird 

populations when conducting agency actions.

Although migratory birds forage in soybean fields, as described in Section 4.4.1, Animals,

SYHT0H2 soybean is not expected to have any adverse impacts on migratory birds because the 

AvHPPD-03 and PAT enzymes do not present a toxicity hazard. Additionally, the Petitioners

conducted a feeding study on broiler chickens, in which no harmful effects were observed. 

Determining non-regulated status for this soybean cultivar therefore is not expected to have a 

negative effect on migratory bird populations. The Preferred Alternative would be in compliance 

with EO 13186, Responsibilities of Federal Agencies to Protect Migratory Birds.

7.2 Executive Orders with International Implications

EO 12114, Environmental Effects Abroad of Major Federal Actions 47, requires federal officials to 

take into consideration any potential environmental effects outside the US, its territories, and 

possessions that may result from actions being taken.

All of the existing national and international regulatory authorities and phytosanitary regimes that 

currently apply to introduction of new soybean cultivars internationally apply equally to those 

covered by an APHIS determination of non-regulated status under 7 CFR part 340. International 

trade of SYHT0H2 soybean subsequent to a determination of non-regulated 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, 1997).

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.” The protection it affords extends to natural flora and plant products and includes both direct 

and indirect damage by pests, including weeds. The IPPC set a standard for the reciprocal acceptance 

of phytosanitary certification among the 177 nations that have signed or acceded to the convention48. 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 the existing International Standard 

for Phytosanitary Measure No. 11 (IPPC, 2004). The standard acknowledges that 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.

46 EO 13186 of January 10, 2001; 66 FR 3853.

47 EO 12114 of January 4, 1979; 44 FR 1957.

48 https://www.ippc.int/

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The Cartagena Protocol on Biosafety (the Protocol) (SCBD, 2000) 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 193 countries are currently parties to it49. Although the US is not a party to the CBD and 

thus not a party to the Protocol, US exporters will still need to comply with domestic regulations that 

importing countries that are parties to the Protocol have put in place to comply with their obligations.

The first intentional transboundary movement of LMOs intended for environmental release (field 

trials or commercial planting) will require consent from the importing country under an advanced 

informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent 

with Annex III of the Protocol, and the required documentation. LMOs imported for food, feed, or 

processing (FFP) are exempt from the AIA procedure, and are covered under Article 11 and 

Annex II of the Protocol. Under Article 11, parties must post decisions to the Biosafety 

Clearinghouse database on domestic use of LMOs for FFP that may be subject to transboundary 

movement. To facilitate compliance with obligations to this protocol, the US government has 

developed a website50 that provides the status of all regulatory reviews completed for different uses 

of bioengineered products. These data will be available to the Biosafety Clearinghouse. International 

trade of SYHT0H2 soybean would be conducted in compliance with the Protocol.

Biosafety and biotechnology consensus documents, guidelines, and regulations, are managed by 

APHIS in accordance with the requirements of the North American Plant Protection Organization 

(NAPPO) and the Organization for Economic Cooperation and Development (OECD). The

Preferred Alternative is not expected to affect APHIS’s participation in NAPPO or the OECD.

The North American Biotechnology Initiative is a forum for information exchange and cooperation 

on agricultural biotechnology issues for the US, Mexico, and Canada. Bilateral discussions on 

biotechnology regulatory issues are also held regularly with other countries including Argentina, 

Brazil, Japan, China, and South Korea.

As described in Section 4.6.2, Foreign Trade Environment, the Preferred Alternative is not 

expected to affect the US soybean export market since the Petitioners are actively pursuing 

regulatory approvals for SYHT0H2 soybean in countries with functioning regulatory systems for 

genetically modified organisms and that import soybean from the US or Canada. Regulatory filings 

for SYHT0H2 soybean import approvals have been made in Canada, Argentina, Japan, Republic of 

China, South Korea, Australia and New Zealand, the Republic of South Africa and the European 

Union. Applications for import approvals in additional countries, including the People’s Republic 

of China, will also be made. 

7.3 Other Federal Laws

In addition to the National Environmental Policy Act and the Plant Protection Act, three other 

federal environmental laws are potentially relevant to the environmental assessment of the petition 

49 http://www.cbd.int/convention/parties/list/

50 http://usbiotechreg.nbii.gov

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to determine nonregulated status for SYHT0H2 soybean. Other federal land management laws and 

regulations address the unique characteristics of certain geographic areas, and are also potentially 

relevant to a determinationof nonregulated status of SYHT0H2 soybean.

7.3.1 Clean Water Act

The Federal Water Pollution Control Act51 (commonly referred to as the Clean Water Act) and 

implementing regulations52 require entities that discharge regulated materials to certain surface 

water bodies (including wetlands) obtain authorization to do so from federal or state agencies 

under various permit programs.

As described in Section 4.3.1, Water Quality and Use, water quality is not likely to change as a direct 

or indirect result of the Preferred Alternative. A determination of nonregulated status of 

SYHT0H2 soybean would not result in a change of agricultural practices or any new discharge of 

pollutants to surface water bodies. Water quality would continue to be regulated and agronomic 

practices to protect water quality would continue to be implemented if SYHT0H2 soybean is no longer 

subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant 

Protection Act of 2000. Cultivating SYHT0H2 soybean would not require Clean Water Act permits 

different than those already required for agricultural activities.

7.3.2 Clean Air Act

The Clean Air Act Amendments of 199053 (commonly referred to as the Clean Air Act) and 

implementing regulations54 require entities that discharge regulated materials into the atmosphere 

obtain authorization to do so from federal or state agencies under various permit programs.

As described in Section 4.3.3, Air Quality, the Preferred Alternative is not likely to directly change 

air quality. SYHT0H2 soybean production would not change land acreage or cultivation practices 

for transgenic or nontransgenic soybean. Air quality would be indirectly improved if conservation 

tillage is increased. Soybean growers would continue current trends in agricultural activities if 

SYHT0H2 soybean is no longer subject to the regulatory requirements of 7 CFR Part 340 or the 

plant pest provisions of the Plant Protection Act of 2000. Cultivating SYHT0H2 soybean would 

not require Clean Air Act permits different than those already required for agricultural activities.

7.3.3 National Historic Preservation Act

The National Historic Preservation Act55 (NHPA) and its implementing regulations56 require 

federal agencies to:

51 33 USC Sections 1251-1376

52 33 CFR parts 320-332 and 40 CFR parts 230-233

53 40 USC 7401-7671

54 40 CFR parts 50-99

55 16 USC Section 470 et seq.

56 36 CFR parts 800-801

– 134 –
• Determine whether activities they propose constitute "undertakings" that have the 

potential to cause effects on historic properties, and

• 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 

Offices, Tribal Historic Preservation Officers), as appropriate.

The Preferred Alternative is not expected to adversely impact cultural resources on tribal 

properties. Any farming activity that may be taken by farmers on tribal lands would be undertaken 

by the tribe or at the tribe’s request. The tribes would have control over any potential conflict with 

cultural resources on tribal properties. The Preferred Alternative would also have no impact on 

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

Register of Historic Places, nor would it cause any loss or destruction of significant scientific, 

cultural, or historical resources.

The Preferred Alternative 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 new visual, 

atmospheric, or noise elements to areas in which they are used that are different from current 

agricultural practices and could result in effects on the character or use of historic properties. The 

cultivation of SYHT0H2 soybean alone or in approved stacks is not expected to change any of 

these agronomic practices that would result in an adverse impact under the NHPA.

7.3.4 Federal Laws Regarding Unique Characteristics of Geographic Areas

Other federal land management laws and regulations protect park lands, prime farm lands, 

wetlands, wild and scenic areas, or ecologically critical areas. A determination of non-regulated 

status for SYHT0H2 soybean is not expected to affect unique characteristics of these geographic 

areas, and the common agricultural practices that would be carried out in the cultivation of 

SYHT0H2 soybean are not expected to deviate from current practices. As described in 

Section 4.2.2, Agronomic Practices, SYHT0H2 soybean is expected to be deployed on agricultural 

land currently suitable for soybean production and replace existing varieties, and is not expected to 

increase the acreage of soybean production.

The Preferred Alternative would not include any major new ground disturbances; new physical 

destruction or damage to property; alterations of property, wildlife habitat, or landscapes; or 

prescribed sale, lease, or transfer of ownership of any property. The Preferred Alternative is limited 

to a determination of non-regulated status of SYHT0H2 soybean. This action would not convert 

agricultural land use to nonagricultural use and therefore would have no adverse impact on prime 

farm land. Standard agricultural practices for land preparation, planting, pest control, irrigation, 

and harvesting of plants would be used on agricultural lands planted to SYHT0H2 soybean, alone 

or when stacked with other soybean varities that are no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000.

– 135 –
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– 159 –
Mesotrione



Appendix A: Mesotrione, 

Isoxaflutole and Glufosinate: 

Changes in Application Rates 

for MGI Soybean 

1
Mesotrione

Table 1. Mesotrione use rates (g active ingredient/Ac) for corn and soybean.

Application timing Corn Use Rate (g ai/Ac) Proposed Soybean Use Rate 

(g ai/Ac) 

Preplant, preplant 

incorporated, or 

preemergence 

85.1 – 109.1 90.7 

Early postemergence 42.5 – 85.1 42.5 – 90.7 

Postemergence 42.5 – 85.1 42.5 – 51.0 

Season maximum rate 85.1 – 109.1 141.6 

Source: EPA label for Callisto Herbicide and amendment for addition of soybean to the label 

Mesotrione soybean use instructions (from EPA label): 

i. Mesotrione can be applied from 14 days prior to planting up through and including the R1 

growth stage for control of weeds in soybeans. 

Table 2. IFT use rates (g active ingredient/Ac) for corn and soybean.

Application timing Corn Use Rate (g ai/Ac) Proposed Soybean Use Rate 

(g ai/Ac) 

Early preplant, preplant 

incorporated (8-30 days prior 

to planting) 

21.3 – 42.6 35.5 – 42.6

Preplant , preplant 

incorporated (0-7 days prior 

to planting) or preemergence 

21.3 – 42.6 28.4 – 42.6 

Early postemergence None 28.4 – 42.6 

Season maximum rate 42.6 42.6 

Source: EPA labels for Balance Pro Herbicide and EXP32032A SC Herbicide

Table 2. Glufosinate use rates (g active ingredient/Ac) for corn and soybean.

Application timing Corn Use Rate (g ai/Ac) Proposed Soybean Use Rate 

(g ai/Ac) 

Preplant burn down 240 - 298 240 – 298 

Postemergence 182 182 - 298 

Season maximum rate 365 538 

Source: EPA label for Liberty Herbicide and amendment for addition of soybean to the label 

Mesotrione soybean use instructions (from EPA label): 

i. Mesotrione can be applied from 14 days prior to planting up through and including the R1 growth 

stage for control of weeds in soybeans.

2
Mesotrione

3
Mesotrione



Appendix B: Mesotrione

Description, Uses, and Potential 

Impacts

4
Mesotrione

Mesotrione:

Description, Uses, and Potential Impact on 

Human Health and the Environment

1. Introduction

This summary describes the uses of mesotrione and its potential impact on human health and the 

environment.

2. Product History

This section describes mesotrione’s chemical name and structure, development, and regulatory status 

in the US.

2.4 Chemical Name and Structure

The chemical name for mesotrione is 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione. 

Mesotrione is a triketone with an empirical formula of C14H13O7NS. Mesotrione degrades in the 

environment to two non-herbicidally active metabolites:

• 4-(methylsulfonyl)-2-nitrobenzoic acid) (MBNA); and

• 2-amino-4-(methylsulfonyl)benzoic acid (AMBA).

Mesotrione is an acidic herbicide with sulfonyl and nitro groups. MNBA and AMBA are benzene 

ring-based acids that remain after the connection to the cyclohexanedione ring is broken (USEPA, 

2001b). MNBA and AMBA also retain the sulfonyl functional group. The chemical structures of 

mesotrione and its metabolites are shown in Figure 1.

2.5 Development

Mesotrione is an active ingredient found in several herbicides for control of broadleaf and certain grassy 

pest weeds. This review focuses on concentrations of mesotrione found in Callisto® herbicide, which is 

approved for use on many row crops including corn, with an experimental use permitted on soybeans. Preemergence use of Callisto on soybean varieties with a degree of native tolerance to mesotrione is an 

approved use, however, Callisto is not currently marketed for this use. Products containing mesotrione for 

use on commercial and residential turf include the herbicide Tenacity®, a solo product. Other Syngenta 

products currently marketed in the US that contain mesotrione are Callisto® Xtra, Halex® GT, Lexar®EZ, 

Lumax®EZ, and Zemax® herbicides. These herbicides contain mesotrione in combination with one or 

more of the following: S-metolachlor57, atrazine58, and glyphosate.59 These products are used primarily on 

corn. Glyphosate, S-metolachlor, and atrazine are not addressed in this summary.

57 The chemical name of S-metolachlor is 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide. It is contained in

Callisto® Xtra, Halex® GT, Lexar® EZ and Lumax® EZ herbicides. 

58 The chemical name of atrazine is 2-chloro-4-(ethylamino)-6-(isopropylamino)-s-triazine. It is contained in Callisto® Xtra, Lexar® EZ, and 

Lumax® EZ herbicides.

59 The chemical name of glyphosate is N-(phosphonomethyl) glycine. It is contained in Halex® GT herbicide

5
Mesotrione

Figure 1: Chemical Structure of Mesotrione and Degradates

6
Mesotrione

2.6 Regulatory Status in the US

All pesticides distributed or sold in the US are subject to registration by the Environmental Protection 

Agency (EPA) under authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

Registration of a pesticide under Section 3 of FIFRA is dependent on consideration of scientific data 

demonstrating that a particular pesticide will not cause unreasonable risks to human health, workers, 

or the environment when used as directed on a product label. EPA is also responsible for identifying 

chemicals that pose health hazards, under the Emergency Planning and Community Response 

Act/Superfund Amendments and Reauthorization Act (EPCRA SARA) Title III Section 311/312 

hazard classification. The US Department of Agriculture and the US Food and Drug Administration 

(FDA) are responsible for enforcing EPA tolerances for pesticides in food.60 This section describes 

the EPA regulatory actions involving mesotrione.

Mesotrione was first registered on June 4, 2001 (USEPA, 2001a). The Food Quality and Protection 

Act of 1996 (FQPA) mandated that the EPA conduct registration reviews of all pesticides distributed 

or sold in the US every 15 years. EPA’s registration review schedule indicates that mesotrione is 

scheduled for re-evaluation starting in 2014. There are 20 current, active FIFRA Section 3 mesotrione 

registrations (USEPA, 2012b). One Experimental Use Permit (Syngenta, 2011b), for application on 

soybeans, was activated in 2009 and has been extended to 2014. There are nine Section 24(c) Special 

Local Need Registrations (for Callisto use on cranberry, blueberry, ryegrass, and cuphea; and for aerial use 

of Halex GT) and ten Section 18 Emergency Exemptions have been issued but have since expired.

Several mesotrione uses have been designated as “reduced risk” by EPA. See Section 5 in this paper 

for information about potential human health effects from mesotrione.

A selected review and regulatory action history of mesotrione within EPA is provided chronologically 

below.

On May 29, 1998, EPA issued a notice in the Federal Register (63 FR 29401) announcing the 

filing of a pesticide petition for tolerances by Zeneca Ag Products (USEPA, 1998). The 

petition was subsequently transferred to Syngenta Crop Protection, Inc. The petition 

requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the 

herbicide 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione (mesotrione) and its 

metabolites or degradates in or on the raw agricultural commodities field corn, field corn 

fodder, and field corn forage at 0.01 parts per million (ppm).

On May 7, 2001, EPA issued a memorandum that provided a chemical review for mesotrione’s use 

in preemergence and postemergence broadleaf weed control in corn and the associated 

environmental fate and ecotoxicity data evaluation records (DERs) (USEPA, 2001b).

On June 6, 2001, the EPA Office of Prevention, Pesticides, and Toxic Substances published the 

Occupational and Residential Exposure and Risk Assessment/Characterization for the 

Proposed use of Mesotrione on Field Corn (USEPA, 2001e).

On June 20, 2001, EPA published a notice in the Federal Register (66 FR 120) establishing the 

tolerance for residues of mesotrione in or on field corn at 0.01 ppm (USEPA, 2001f).

60 The FDA website does not have any information about enforcement actions in regard to EPA tolerances for mesotrione in food.

7
Mesotrione

On December 22, 2008, the EPA Office of Prevention, Pesticides, and Toxic Substances published 

the Ecological Risk Assessment for Experimental Use Permit (DP Barcode 354510) and Section 

3 New Use (DP Barcode 357888) registrations for use of mesotrione on soybeans (USEPA, 

2008c). The Section 3 New Use applied for at that time supported preemergence applications on 

soybean varieties with a degree of native tolerance to mesotrione.

On December 18, 2009, EPA published a notice in the Federal Register (74 FR 242) 

establishing the tolerance for residues of mesotrione in or on soybean seed at 0.01 ppm as a 

new use of this herbicide (USEPA, 2009b). This tolerance supported preemergence 

applications of mesotrione on certain soybean varieties exhibiting native tolerance to the 

herbicide.

In 2013, Syngenta applied to EPA for a new, postemergence use of mesotrione on soybean and 

amended soybean tolerances (USEPA, 2013). These amendments to the registrations and tolerances will 

support the intended rates and timing of mesotrione applications on soybean cultivars genetically 

modified for tolerance of HPPD-inhibitor herbicides.

Tolerance levels for residues of mesotrione (and its metabolites or degradates) are listed in 40 CFR 

part 180.571. Current tolerance limits are discussed in Section 3.3.1 of this paper.

3. Function

This section describes mesotrione’s mode of action, herbicide class, and usage.

3.4 Mode of Action and Herbicide Class

Mesotrione is an inhibitor of 4-hydroxyphenyl-pyruvate-dioxygenase (4-HPPD). The mode of action 

prevents the biosynthesis of carotenoid pigments that protect chlorophyll from decomposition by 

sunlight (USEPA, 2001c). HPPD enzymes have also been isolated from bacteria, fungi, animals, and 

humans (Coats, 2009). HPPD enzymes from diverse origins share a common structure and have several 

highly conserved amino acid sequences among all HPPD proteins. HPPD activity is implicated in the 

tyrosine metabolism of microorganisms, plants, and mammals.

In plants, HPPD catalyzes the conversion of p-hydroxyphenyl-pyruvate to homogentisate (which is an 

aromatic precursor of vitamin E) and plastoquinones (which are antioxidant compounds and elements 

of the chloroplast electron-transfer chain) (Matringe et al., 2005). This pathway is schematically 

depicted in Figure 2. Plastoquinone is a critical cofactor for phytoene desaturase, a component of the 

carotenoid biosynthetic pathway. Depletion of plastoquinone levels by inhibition of HPPD results in 

depletion of carotenoids, leading to bleaching symptoms. Without carotenoids, light energy destroys 

the chlorophyll, causing new growth to turn white and disrupting cell membranes, resulting in 

necrosis and death of susceptible plants (Syngenta, 2008).

Mesotrione is a benzoylcyclohexanedione (triketone) herbicide. The Herbicide Resistance Action 

Committee (HRAC) classifies the mesotrione mode of action as F2, a carotenoid biosynthesis 

inhibitor (inhibition of 4-HPPD) (HRAC, 2013).

8
Mesotrione

3.5 Usage

3.5.4 Current US Uses and Established Tolerances

Syngenta’s label for Callisto identifies this product as “a systemic postemergence and preemergence 

herbicide for the selective contact and residual control of broadleaf weeds in field corn, seed field 

corn, yellow popcorn, sweet corn, and other listed crops” (Syngenta, 2011a). Other listed crops are 

cranberry, blueberry, lingonberry, flax, pearl millet, asparagus, Kentucky bluegrass, perennial 

ryegrass, tall fescue, oats, rhubarb, black raspberry, red raspberry, blackberry, okra, grain sorghum, 

sweet sorghum, certain tolerant soybean cultivars (i.e., cultivars with native tolerance to preemergence Callisto applications), and sugarcane. Use on bluegrass, ryegrass, and fescue is only for 

when these are grown for seed. Use on soybeans is not currently indicated on the Callisto commercial 

label. Mesotrione is registered for use on commercial and residential turf (USEPA, 2009b) on the 

Tenacity® product label.

Figure 2: Mesotrione Mode of Action

9
Mesotrione

Mesotrione is the active ingredient (ai) in the Callisto herbicide and comprises 40 percent of that 

formulation. Non-active ingredients comprise the remaining 60 percent. The Syngenta label for Callisto 

states that when this product is used preemergence, weeds take up the product through the soil during 

their emergence. When used postemergence, susceptible weeds take up the herbicide through the treated 

foliage and cease growth soon after application. Complete death of the weeds may take up to 2 weeks.

To help prevent the development of weed resistance to Callisto, Syngenta recommends that 

applicators always use full labeled rates. If applying Callisto postemergence in corn after a 

mesotrione-containing preemergence herbicide, atrazine should always be added as a tank mix 

partner. No more than 0.24 pounds of active ingredient per acre (lb ai/A) of corn should be applied per 

year (equivalent of 7.7 fluid ounces of Callisto per acre per year).

Rotational crop information provided on the Callisto label is:

Immediate: Corn (all types), asparagus, cranberry, flax, millet (pearl), grasses grown for seed 

(Kentucky bluegrass, perennial ryegrass, and tall fescue), oats, rhubarb, sorghum (grain and sweet), 

and sugarcane may be replanted immediately.

120 Days: Small grains may be planted 120 days after application.

10 Months: Alfalfa, blueberry, canola, cotton, lingonberry, peanuts, potatoes, soybeans, sunflowers, 

and tobacco can be planted back the following season but not less than 10 months after the last 

Callisto application. If Callisto is applied postemergence following a mesotrione-containing 

preemergence herbicide, only corn (all types) or grain sorghum may be replanted the year following 

application, or severe crop injury may occur.

18 Months: Sugar beets, peas, dry beans, snap beans, cucurbits, red clover, and all other rotational crops 

may be replanted 18 months after application of Callisto. Planting unspecified rotational crops, or 

those rotational crops that are specified at shorter than recommended intervals, may result in injury 

to the rotational crop.

Table 1 lists the currently established tolerances for residues of mesotrione and its metabolites or 

degradates, as published in 40 CFR part 180.571.

3.5.5 Application method

Mesotrione can be applied preemergence by ground equipment with a 14-day application interval 

(USEPA, 2001b). The current Callisto label indicates that aerial application is not allowed. 

Postemergence applications should be made when annual broadleaf weeds are less than 5 inches tall but 

before corn reaches 30 inches in height. Adjuvants (nonionic surfactants or crop oil concentrate) and 

added nitrogen (ammonium sulfate or urea ammonium nitrate) are required for postemergence use.

10
Mesotrione

Table 1 Established Tolerances for Residues of Mesotrione (and degradates or 

metabolites) in or on Raw Agricultural Commodities

Commodity Tolerance Limit (ppm)

Asparagus 0.01

Berry, group 13 0.01

Corn, field, forage 0.01

Corn, field, grain 0.01

Corn, field, stover 0.01

Corn, pop, grain 0.01

Corn, pop, stover 0.01

Corn, sweet, forage 0.50

Corn, sweet, kernel plus cob with husks removed 0.01

Corn, sweet, stover 1.50

Cranberry 0.02

Flax, seed 0.01

Grass, forage 0.01

Grass, hay 0.01

Grass, seed screenings 0.10

Grass, straw 0.10

Lingonberry 0.01

Millet, forage 0.01

Millet, grain 0.01

Millet, hay 0.02

Millet, straw 0.02

Oat, forage 0.01

Oat, grain 0.01

Oat, hay 0.01

Oat, straw 0.01

Okra 0.01

Rhubarb 0.01

Sorghum, grain, forage 0.01

Sorghum, grain, grain 0.01

Sorghum, grain, stover 0.01

Sorghum, sweet 0.01

Soybean, seed 0.01

Sugarcane, cane 0.01

Source: (USEPA, 2013)

11
Mesotrione

3.5.6 Usage Rates

The current maximum single application rates for registered uses were established in 2008 and range 

from 0.094 to 0.25 lb ai/A; the annual total (twice per season) application rates range from 0.188 to 

0.5 lb ai/A (USEPA, 2008c). In 2009, Syngenta was granted a 3-year Experimental Use Permit by EPA 

(100-EUP-114) for testing mesotrione on HPPD-inhibitor-tolerant soybeans. The Experimental Use 

Permit, extended through 2014, has an annual application rate of 1.5 lb ai/A (Syngenta, 2011b), three 

times the highest previously registered seasonal application rate. However, these rates are for crop 

tolerance testing purposes only. The approved new (in 2009) use of mesotrione on soybeans has a

registered application rate of 0.188 lb ai/A per season, at the low end of the approved application 

rates for other crops. The proposed seasonal maximum for Callisto on HPPD-inhibitor-tolerant 

soybeans will be 0.31 lb ai/A, within the range of the annual total application rates for registered uses.

The US Geological Survey (USGS) estimated average annual agricultural use for numerous pesticides, 

including mesotrione, based on a 4-year period from 1999 to 2002 (USGS, 2002). USGS estimated that 

621,658 pounds of mesotrione (as the active ingredient in various herbicide mixtures) would be applied to 

US corn fields in 2002. Although the data are over 10 years old, Figure 3, showing annual mesotrione 

usage in 2002, provides a visual image of the intensity and extent of its application in that time period.

Figure 3 Estimated Agricultural Use of Mesotrione in 2002

12
Mesotrione

3.5.7 Target Weeds

Mesotrione provides control or partial control for a range of broadleaf weeds in postemergence or 

preemergence applications, as listed below. In postemergence applications, mesotrione may be used 

alone when weeds are less than 5 inches tall, or in combination with other herbicides (such as 

S-metolachlor and atrazine) for corn and sugarcane when weeds are less than 5 inches or between 

5 and 10 inches tall. In preemergence applications, it may be used alone or in combination with other 

herbicides on corn, sorghum, and sugarcane.

Weeds Controlled with Postemergence Applications of Callisto

Amaranth, Palmer

Amaranth, Powell

Amaranth, spiny

Atriplex

Broadleaf signalgrass

Buckwheat, wild

Buffalobur

Burcucumber

Carpetweed

Carrot, wild

Chickweed, common

Cocklebur, common

Crabgrass, large

Dandelion

Dock, curly

Galinsoga

Hemp

Horse nettle

Jimsonweed

Knotweed, prostrate

Kochia

Lambsquarters, common

Mallow, Venice

Morningglory, entireleaf; ivyleaf

Morningglory, pitted

Mustard, wild

Nightshade, black

Nightshade, eastern black

Nightshade, hairy

Nutsedge, yellow

Pigweed, redroot

Pigweed, smooth

Pigweed, tumble

Pokeweed, common

Potatoes, volunteer

Pusley, Florida

Ragweed, common

Ragweed, giant

Sesbania, hemp

Sida, prickly (teaweed)

Smartweed, ladysthumb

Smartweed, pale

Smartweed, Pennsylvania

Sunflower, common

Thistle, Canada

Velvetleaf

Waterhemp, common

Waterhemp, tall

Weeds Controlled with Preemergence Applications of Callisto

Amaranth, Palmer

Amaranth, Powell

Amaranth, spiny

Broadleaf signalgrass

Buffalobur

Carpetweed

Chickweed, common

Cocklebur, common

Crabgrass, large

Galinsoga

Jimsonweed

Kochia

Lambsquarters, common

Morningglory, entireleaf; 

ivyleaf

Morningglory, pitted

Nightshade, eastern black

Nightshade, hairy

Pigweed, redroot

Pigweed, smooth

Pigweed, tumble

Ragweed, common

Ragweed, giant

Smartweed, ladysthumb

Smartweed, pale

Smartweed, Pennsylvania

Sunflower, common

Velvetleaf

Waterhemp, common

Waterhemp, tall

13
Mesotrione

3.5.8 Tolerant Weeds

According to the International Survey of Herbicide Resistant Weeds, certain biotypes of common 

waterhemp (Amaranthus tuberculatus (syn. rudis)) and Palmer amaranth (Amaranthus palmeri) are 

the only weeds currently known to have developed tolerance to post-emergence applied HPPDinhibitor herbicides, including mesotrione (Heap, 2013b). Common waterhemp and Palmer 

amaranth are dicot weeds in the Amaranthaceae family. HPPD-inhibitor resistant biotypes of 

common waterhemp have been identified in limited areas of Illinois, Iowa, and Nebraska, and 

HPPD-inhibitor resistant biotypes of Palmer amaranth have been identified in limited areas of 

Kansas and Nebraska. Certain biotypes of these weeds are also known to have resistance to other 

herbicide modes of action.

4. Environmental Fate and Ecological Effects

This section describes the environmental fate and ecological effects of mesotrione. Section 4.1 

describes the toxicological effects of mesotrione and its metabolites on plants and animals 

(including humans), based principally on EPA review documents. Sections 4.2 and 4.3 describe 

mesotrione’s persistence in soil and water, and Section 4.4 discusses its effects on soil microbes. 

Sections 4.5 and 4.6 explain the risk to plants and animals, respectively, from application of 

mesotrione as an herbicide on agricultural fields. Human health effects are described in Section 5.

The ecological effects of mesotrione are driven, in part, by its chemical properties and 

environmental fate parameters, as listed in Table 2.

Table 2 General Chemical Properties and Environmental Fate Parameters for 

Mesotrione

Parameter Value

Selected Physical and Chemical Parameters

Molecular mass 339.3 g/mol

Vapor pressure (20oC) 4.3 x10-8 torr

Water solubility(20oC) 1.5g/100ml at pH 6.9

Partition coefficient (octanol-water) Log Pow = 0.11 in unbuffered water

Bioconcentration Not expected

Persistence

Hydrolysis half-life Stable

Aqueous photolysis half-life 84 days

Soil photolysis half-life 30 days

Aerobic soil metabolism half-life 5 to 32 days

Anaerobic aqueous metabolism half-life 4 days

Aerobic aqueous metabolism half-life 3 to 6 days

Mobility

Organic carbon distribution coefficient (KOC) 16 to 390 mL/goc

Field Dissipation
Mesotrione

Terrestrial field dissipation half-life range 2 to 14 days

Sources: (USEPA, 2001b; USEPA, 2008c)

4.4 Toxicology of Mesotrione and Metabolites

As mentioned in Section 3.1, Chemical Name and Structure, mesotrione is a triketone and 

metabolism of mesotrione leads to two major degradates: MNBA, formed through aerobic 

metabolism, and AMBA, formed through anaerobic metabolism (USEPA, 2008c). Carbon 

dioxide is a final degradate of the metabolites.

EPA’s chemical review (USEPA, 2001b) for mesotrione’s toxicological effects on plants and 

animals is summarized in tables appended to this paper. In regard to plants, EPA concluded that 

adverse effects were seen in both nontarget monocots and dicots. Specifically:

For crop seedling emergence, lettuce is the most sensitive dicot and onion is the most 

sensitive monocot;

For crop vegetative vigor, tomato is the most sensitive dicot and onion is the most sensitive 

monocot; and

Kirchneria subcapitata (a green algae) is the most sensitive nonvascular aquatic plant.

In regard to animals, EPA concluded that mesotrione is:

Practically nontoxic to avian species on a subacute dietary basis;

Practically nontoxic to the bobwhite on an acute oral basis;

Practically nontoxic to small mammals on an acute and chronic oral basis;

Practically nontoxic to bees on an acute contact basis;

Practically nontoxic to freshwater fish on an acute basis;

Practically nontoxic to aquatic invertebrates on an acute basis;

Practically nontoxic to estuarine/marine fish on an acute basis; and

Moderately toxic to slightly toxic to estuarine/marine invertebrates on an acute basis.

EPA’s most recent hazard assessment of mesotrione (USEPA, 2009a) states that mesotrione has low 

acute toxicity via oral, dermal adsorption, and inhalation routes. It is a mild eye irritant, but is not a 

dermal irritant or dermal sensitizer. In subchronic and chronic oral studies, ocular lesions, liver and 

kidney effects, and /or body-weight decrements were the major adverse effects seen in the rat, 

mouse, and dog at high doses. Plasma tyrosine levels were increased in the rat, mouse, and dog in the 

chronic and reproductive studies in which they were measured. The ocular, liver and kidney effects 

are believed to be mediated by the high tyrosine levels in the blood caused by inhibition of the 

enzyme HPPD. Even though the rat is the most sensitive species to this effect compared to the dog 

and the mouse, EPA’s Health Effects Division (HED) Mechanism of Toxicity Science Advisor 

Review Committee (MTSARC) concluded that the mouse is a more appropriate model for assessing 

human risk than is the rat. There was no evidence of carcinogenic potential in either the rat chronic 

toxicity/carcinogenicity or mouse carcinogenicity studies and no concerns for mutagenicity. No 
Mesotrione

evidence of neurotoxicity or neuropathology was seen in the acute and subchronic neurotoxicity 

studies. In the multi-generation mouse reproduction study, one F1 male and one F1 female had retinal 

detachment with marked cataractous changes at the highest dose tested (greater than 

1,000 mg/kg/day). In the subchronic toxicity dog study, the high-dose females had decreased 

absolute and relative brain weights; however, no microscopic abnormalities were noted in any brain 

tissue from the high-dose group and the effect was not observed in the chronic toxicity dog study.

Based on the overall weight of evidence, HED concluded that the requirement of a developmental 

neurotoxicity study is waived, and the Food Quality Protection Act (FQPA) safety factor for the 

incomplete database is set at 1X. In a toxicology evaluation (USEPA, 2001d), MNBA and AMBA 

were determined to have low acute oral toxicity; MNBA has low dermal toxicity. MNBA caused an 

increase in motor activity in adult female rats. MNBA and AMBA are very weak to weak inhibitors of 

HPPD in vitro and it appears they will not perturb tyrosine catabolism in vivo.

An independent study (Elskus et al., 2008) of certain stressors61 to Atlantic salmon determined that 

Callisto (as well as other pesticides) had no significant effect on innate immunity, development 

rate or behavior (spontaneous swimming, prey capture) in zebrafish (as a toxicological model for 

early life stage Atlantic salmon).

4.5 Persistence in Soil

Mesotrione is approximately 40 times more acidic than acetic acid, which influences its behavior 

in environmental media at different pHs (USEPA, 2001b). There is a high correlation between pH 

and sorption to soil organic matter, and a moderate correlation between pH and soil "half-life." 

Mesotrione, MNBA, and AMBA have low to very low sorption to tested soils/sediments at the 

more neutral pHs, indicating potential for leaching and runoff (USEPA, 2001b).

Mesotrione has low sorption to soils/sediments at all pHs tested (Koc: 16 to 390 mL/g) and is 

moderately mobile to mobile (USEPA, 2008c). Mesotrione is relatively short-lived in soil, tending to 

offset the opportunity for leaching and runoff (USEPA, 2001b). Photolysis, aerobic and anaerobic 

soil metabolism, and terrestrial field dissipation studies indicate that mesotrione is not persistent in 

soil (USEPA, 2001g). Mesotrione dissipates through aerobic soil metabolism with rates dependent 

on ambient conditions (half life of 5 to 32 days) (USEPA, 2008c).

Volatilization of mesotrione and its transformation products (except for carbon dioxide) is not indicated 

(USEPA, 2001b). As shown in Table 3, the vapor pressure of mesotrione is relatively low (compared to 

other herbicides such as dicamba and 2,4-D). Mesotrione vapors are not transported by wind for 

deposition on soil away from application sites.

4.6 Persistence in Water

Mesotrione may reach surface water through spray drift and/or runoff. In aquatic environments, 

mesotrione is stable to hydrolysis and has limited photolysis but dissipates rapidly through aerobic 

(half life of 3 to 6 days) and anaerobic (half life of 4 days) metabolism (USEPA, 2008c). 

Mesotrione is not persistent in water but its degradates MNBA and AMBA may be persistent 

61 Pesticides used on blueberries, acidity, and aluminum concentrations in water.
Mesotrione

under suboxic (groundwater) conditions (USEPA, 2001g). Under suboxic or anoxic conditions, as 

would be associated with groundwater, MNBA would be reduced to AMBA (USEPA, 2001b).

Field dissipation and prospective groundwater (PGW) studies to evaluate the potential for 

mesotrione, MNBA, and AMBA to reach groundwater were reviewed by EPA. The 2002 Drinking 

Water Assessment (USEPA, 2002) concludes that:

Laboratory results are supported by results from field studies. Terrestrial field dissipation 

studies showed dissipation half-lives of 2 to 14 days and did not find any residues below 

6 inches, although review of these studies found they did not adequately account for 

dissipation. A prospective groundwater study (PGW) was conducted in Michigan and 

found no leaching, but the study was determined not to represent conditions of upper bound 

vulnerability. Another PGW is ongoing in North Carolina.

The review (USEPA, 2008b) of the PGW study conducted in North Carolina states that:

Mesotrione and its degradates were detected above the limit of quantification only in soilpore water at the 3-foot depth. Detections were found at four of the eight 3-ft lysimeters 

with breakthrough of parent and/or degradates occurring at 0.5 to 1.5 MAT and no 

detections after 3.5 MAT. Peak parent concentrations at one lysimeter reached 11 ppb and 

at the others were less than or equal to 2 ppb with degradate concentrations all at less than 

or equal to 0.48 ppb mesotrione equivalents. The AMBA results may under represent 

actual concentrations due to the poor storage stability, but this is not expected to affect 

study conclusions. Throughout the 38 months of the study, no detections of parent or 

degradates were made at any deeper lysimeters or in ground water. The clear pattern of 

increase and decline at the 3-ft lysimeters suggests that the compound reached this depth 

and dissipated through regular sorption and degradation processes rather than through 

preferential flow or a rapid initial pulse following a precipitation event. The lack of 

detection at deeper locations, then, can be interpreted as evidence that leaching is not 

expected, rather than of insufficient sampling time.

4.7 Effect on Soil Microbes

EPA does not evaluate risk to microbial communities as part of its pesticide review process. EPA did 

conclude that bioconcentration of mesotrione, MNBA, and AMBA in soils is not expected (USEPA, 

2001b).

4.8 Risk to Plants

Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the 

likelihood of adverse ecological effects. EPA conducted a screening level risk characterization by the 

risk quotient (RQ) method. RQs are calculated by dividing estimated environmental concentrations 

(EECs) by acute and chronic ecotoxicity values. RQs are then compared to EPA’s levels of concern 

(LOCs) defined by the EPA for acute and chronic exposures where an RQ greater than the LOC 

value indicates a potential screening-level risk. For screening level findings with an RQ greater than 

the LOC, EPA performs a more refined risk assessment using multiple lines of evidence to more 

specifically characterize exposure and ecotoxicity.
Mesotrione

The risk to plants was assessed for different application rates for Callisto on corn and other listed 

crops. For all application scenarios for mesotrione in the Callisto formulation (see Section 3.3.4), 

EPA’s acute LOCs are exceeded for monocots and dicots in dry and semi-aquatic areas (USEPA, 

2001b). An exception is for monocots in a dry area for either single applications (aerial or ground) 

or for two ground applications using monocot seedling emergence data.

The application rate of 0.188 lb ai/A proposed by Syngenta in 2008 for the preemergence use on 

soybean varieties with some natural mesotrione tolerance is approximately equal to the lowest 

previously registered rate. EPA concluded that potential adverse environmental effects to aquatic 

plants were minimal from the proposed new use (USEPA, 2008c). The Experimental Use Permit 

application rate slightly exceeded EPA’s LOCs for aquatic vascular plants but the new use 

application rate did not; no exceedances were noted for non-vascular plants. Table 3 shows the RQs 

associated with the aquatic vascular plants for soybean and sugarcane mesotrione use (bold values).

Table 3 Acute RQ Values for Aquatic Vascular Plants Exposed to Mesotrione

Use Peak EEC (ppb)

Vascular Plant RQs

(EEC/EC50)

Soybean Preemergence Use 5.1 0.5

Soybean Experimental Use 25.1 2.6

Sugarcane 12.5 1.3

Source: (USEPA, 2008c)

4.9 Risk to Animals

EPA has concluded that mesotrione is unlikely to present a risk to aquatic and terrestrial animals 

on an acute or chronic basis (USEPA, 2001b). EPA indicated that loss of habitat and food items 

may indirectly affect terrestrial and aquatic organisms as a result of damage to non-target plants 

from off-target transport (e.g., spray drift or run-off).

The new use of mesotrione on soybeans approved in 2009 was for a preemergence application rate of 

0.188 lb/ai/A per year, equivalent to the lowest previously registered rate. Even at the increased 

application rate of 1.5 lb/ai/A of the Experimental Use Permit for soybeans (three times the 

maximum registered rate), all categories of risk to aquatic animals resulted in RQs of less than 0.01 

(USEPA, 2008c). Additional risks to terrestrial animals from the Experimental Use Permit 

application rate were considered by the EPA. Risk to mammals and invertebrates remained minimal, 

but some LOCs for birds were slightly exceeded. Chronic exposure RQs for birds that feed on short 

grass (RQ = 2.6), tall grass (RQ = 1.2), or broadleaf plants and small insects (RQ = 1.5), exceeded 

the LOC of 1. For all other classes of birds, acute and chronic exposure RQs are below LOCs. A 

summary of the environmental risk to animals from soybean application rates is provided in Table 4.
Mesotrione

Table 4 Summary of Environmental Risks for Use of Mesotrione on Soybeans

Assessment Endpoint

Risk to Animals

(0.188 lb ai/A/yr)

Acute and Chronic Risk to Freshwater and Marine/ Estuarine Fish and 

Amphibians

None

Acute and Chronic Risk to Freshwater and Marine/ Estuarine Invertebrates None

Acute and Chronic Risk to Mammals None

Acute and Chronic Risk to Birds and Reptiles None

Risk to Terrestrial Invertebrates None likely, based on 

honeybee toxicity data

Source: (USEPA, 2008c)

5. Human Health Effects

5.4 Human Health Risks

EPA evaluates available animal toxicity data to determine human health risk. In the most recent 

hazard assessment for mesotrione (USEPA, 2009a), EPA states that the chronic reference dose 

(cRFD), short- and intermediate-term incidental exposure and dermal endpoints are based on the 

lowest-observed adverse-effect level (LOAEL) of 2.1 mg/kg/day based on tyrosinemia in F1 and 

F2 offspring and ocular discharge in F1 pups seen in a reproduction study in mice. The HED 

mesotrione risk assessment team concluded that the FQPA safety factor of 3X for use of LOAEL 

(instead of a no observed adverse effect level (NOAEL)) is adequate for addressing any 

uncertainties associated.

No appropriate endpoint was identified to quantify risk to the general US population or to females 

13 to 50 years old from a single-dose administration of mesotrione. Therefore, there is no acute 

reference dose (aRFD). The short- and intermediate-term endpoints for all routes of exposure 

(dermal, inhalation, and oral) are based on tyrosinemia in adults and pups and ocular discharge in 

pups observed in a mouse reproduction study. The cRFD is 0.007 mg/kg/day. Mesotrione is 

classified as “not likely to be carcinogenic to humans” based upon lack of evidence of 

carcinogenicity in rats and mice. Therefore, a cancer risk assessment is not required. Since an oral 

study was selected for all durations of inhalation exposure, an unrealistically high 100 percent 

inhalation-absorption factor (relative to oral absorption) was used in the route-to-route extrapolation. 

Based on the results of an in vivo dermal-absorption study, a dermal-absorption factor of 1 percent 

was used for dermal exposure assessment.

The FQPA safety factor is 3X; consequently, the chronic population-adjusted dose (cPAD) value is 

0.007 mg/kg/day. In the dietary exposure and risk assessment, food and water exposure estimates 

are not of concern (less than 100 percent of the cPAD).
Mesotrione

5.5 Occupational Health Risks

Risks to agricultural workers were also considered by EPA in the Occupational and Residential 

Exposure Risk Assessment for mesotrione under the Callisto formulation (USEPA, 2001e). In the 

most recent hazard assessment for mesotrione (USEPA, 2009a), EPA concluded that residential 

handler exposure is not of concern. Short-term aggregate margins of exposure (MOEs) for the 

adult, youth, and toddler population subgroups and the intermediate-term aggregate MOE for the 

toddler population subgroup were assessed, and are not of concern to HED (MOEs greater 

than 300).

Short- and intermediate-term estimated risks for handlers are not of concern provided handlers of 

liquid formulations wear protective gloves. Since the proposed label for the liquid formulation 

included gloves as required PPE, HED concluded that handler risk is not of concern. There are no 

short-term occupational post-application dermal risks of concern on day 0 for all post-application 

activities.

Mesotrione is classified in Toxicity Category III for acute dermal and Category IV for acute oral, 

acute inhalation, and primary eye and skin irritation. It is not a dermal sensitizer. Therefore, the 

Worker Protection Standard (WPS) interim restricted-entry interval (REI) of 12 hours is adequate 

to protect agricultural workers from post-application exposures to mesotrione. The labels currently 

have REIs of 12 hours or more.

Syngenta has prepared Material Safety Data Sheets (MSDSs) for Callisto (Syngenta, 2012a) with 

mesotrione as the active ingredient at 40 percent concentration, and for Mesotrione Technical 

(Syngenta, 2011c) at 79 percent concentration. The MSDSs are similar because they focus on 

active ingredient rather than other ingredients, and provide toxicological and ecological 

information summarized from EPA reviews (Section 4.1). The toxicological information for 

mesotrione provided in Section 11 of the MSDS is based on animal toxicological studies. The 

toxicity data from the Callisto MSDS are consistent with the toxicological data compiled by EPA 

(as summarized in Section 4.6 and appended to this paper) and are provided in Table 5.

Table 5 Callisto MSDS Acute and Chronic Toxicity Data

Parameter Test Animal Exposure Limit

Acute ingestion toxicity Rabbit, rat LD50: >5,000 mg/kg body weight

Acute dermal toxicity Rabbit, rat LD50: >5,000 mg/kg body weight

Acute inhalation toxicity Rat LC50: >5.19 mg/L – 4 hours

Eye contact Rabbit Mildly irritating

Skin contact Rabbit Slightly irritating

Sensitization Guinea pig Not a sensitizer

Reproductive & 

developmental toxicity

Not specified Not a reproductive or developmental hazard.

Chronic/subchronic toxicity Not specified Animal studies showed evidence of reduced bodyweight 
Mesotrione

gain, increased liver and kidney weights, blood effects 

(polycythemia, reduced white blood cell count) and eye 

effects (cataract formation, keratitis). No known 

neurotoxic effect based on animal studies.

Carcinogenicity Not specified Not carcinogenic in animal studies; not mutagenic.

Source: (Syngenta, 2010a; Syngenta, 2012a)
Mesotrione

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Mesotrione

Appendix C: Sample 

Management Plans for 

SYHT0H2 Soybean 
Mesotrione

Burndown with POST 

Emergent Application

Burndown Alternate 1 Glufosinate and 

Broadleaf residual

-or- Paraquat orglyphosate or 

mesotrione or 

IFT

Burndown Alternate 2 Residual grass 

herbicide

and/or- broadleaf 

herbicide (such as 

s-metolachlor or 

metribuzin)

-or- Paraquat orglyphosate

Preplant N/A

POST (Early) N/A

POST Glufosinate -with or withoutmesotrione or 

IFT or soybean 

selective 

herbicide

Preplant with POST Emergent Application

Burndown N/A

Preplant Mesotrione or IFT -and- Residual 

grass herbicidewith or withoutbroadleaf 

herbicide (smetolachlor or 

metribuzin)

POST (Early) N/A

POST Alternate 1 Glufosinate (1x-2x)

POST Alternate 2 Glufosinate (1x-2x) -and- Soybean 

selective 
Mesotrione

herbicide (smetolachlor or 

fomesafen)

Burndown with Early POST Application

Burndown Glufosinate -or- Paraquat orglyphosate

Preplant N/A

POST (Early) Mesotrione or 

IFT

-and- Soybean 

selective 

residuals (as 

recommended 

on label, such as 

s-metolochlor or 

fomesafen)

POST N/A