# 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

E NVIRONMENTAL 

# R EPORT

April 2013– i – 

## Table of Contents

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

1 PURPOSE AND NEED .....................................................................................................1 1.1 Regulatory Authority ..................................................................................................1
1.1.1 Animal and Plant Health Inspection Service ..................................................1 1.1.2 Environmental Protection Agency ..................................................................2 1.1.3 Food and Drug Administration .......................................................................3 1.2 Petition for Determination of Nonre gulated Status: Herbicide-Tolerant SYHT0H2 Soybean ....................................................................................................3 1.3 Purpose of and Need for Product ................................................................................4 1.4 Purpose and Need for APHIS Action .........................................................................5 1.5 Public Involvement .....................................................................................................5 1.6 Resources Considered .................................................................................................5

2 AFFECTED ENVIRONMENT ........................................................................................7
2.1 Soybean Biology .........................................................................................................7 2.2 Agricultural Production of Soybean ...........................................................................9
2.2.1 Current and Projected Acreage a nd Range of Soybean Production ...............9 2.2.2 Agronomic Practices .....................................................................................11 2.2.3 Commercial Soybean Production and Uses ..................................................30 2.3 Physical Environment ...............................................................................................37
2.3.1 Soil ................................................................................................................37 2.3.2 Water Quality ................................................................................................39 2.3.3 Air Quality ....................................................................................................40 2.3.4 Climate ..........................................................................................................41 2.4 Biological Resources ................................................................................................42
2.4.1 Animal Communities ....................................................................................42 2.4.2 Plant Communities ........................................................................................43 2.4.3 Soil Microorganisms .....................................................................................44 2.4.4 Biodiversity ...................................................................................................44 2.4.5 Gene Movement in the Natural Environment ...............................................47 2.5 Public Health.............................................................................................................48
2.5.1 Human Health ...............................................................................................48 2.5.2 Worker Safety ...............................................................................................50 2.5.3 Animal (Livestock) Health ...........................................................................51 2.6 Socioeconomic Factors .............................................................................................51
2.6.1 Domestic Trade Environment .......................................................................52 2.6.2 Foreign Trade Environment ..........................................................................54 2.6.3 Social and Economic Environment ...............................................................56– ii – 3 ALTERNATIVES ............................................................................................................59
3.1 No Action: Continuation as a Regulated Article ......................................................59 3.2 Preferred Alternative: Determination that SYHT0H2 Soybean is No Longer a Regulated Article ......................................................................................................59 3.3 Comparison of Alternatives ......................................................................................60

4 ENVIRONMENTAL CONSEQUENCES .....................................................................63
4.1 Introduction ...............................................................................................................63
4.1.1 Scope of the Environmental Analysis ...........................................................63 4.1.2 Methodology .................................................................................................64 4.1.3 Assumptions ..................................................................................................65 4.2 Soybean Production ..................................................................................................66
4.2.1 Acreage and Areas of Soybean Production ..................................................67 4.2.2 Agronomic Practices .....................................................................................68 4.2.3 Commercial Soybean Production and Uses ..................................................76 4.3 Physical Environment ...............................................................................................79
4.3.1 Soil ................................................................................................................79 4.3.2 Water Quality and Use ..................................................................................81 4.3.3 Air Quality ....................................................................................................82 4.3.4 Climate ..........................................................................................................83 4.4 Natural Biological Communitie s (Non-Target Organisms)......................................83
4.4.1 Animals .........................................................................................................84 4.4.2 Plants .............................................................................................................85 4.4.3 Soil Microorganisms .....................................................................................86 4.4.4 Biodiversity ...................................................................................................87 4.4.5 Gene Movement in the Natural Environment ...............................................90 4.5 Public Health.............................................................................................................91
4.5.1 Human Health ...............................................................................................91 4.5.2 Worker Safety ...............................................................................................94 4.5.3 Animal (Livestock) Health ...........................................................................95 4.6 Socioeconomic Factors .............................................................................................96
4.6.1 Domestic Trade Environment .......................................................................96 4.6.2 Foreign Trade Environment ..........................................................................98 4.6.3 Social and Economic Environment ...............................................................99

5 CUMULATIVE EFFECTS ...........................................................................................101
5.1 Introduction .............................................................................................................101 5.2 Agronomic Practices ...............................................................................................102 5.3 Water Quality and Use ............................................................................................103 5.4 Soil .......................................................................................................................... 104 5.5 Air Quality ..............................................................................................................104 5.6 Plants .......................................................................................................................1 04 5.7 Soil Microorganisms ...............................................................................................105– iii – 5.8 Biodiversity .............................................................................................................105 5.9 Domestic Trade Environment .................................................................................105

6 THREATENED AND END ANGERED SPECIES .....................................................107
6.1 Potential Effects of SYHT0H2 Soybean on Threatened or Endangered Species ...108
6.1.1 Threatened and Endangered Plant Species .................................................108 6.1.2 Threatened and Endangered Animal Species .............................................109 6.1.3 Conclusion ..................................................................................................110 6.2 Potential Effects of the Use of Meso trione, Isoxaflutole, and Glufosinate ............111
6.2.1 Ecological Risks of Mesotrione ..................................................................112 6.2.2 Ecological Risks of Isoxaflutole .................................................................113 6.2.3 Ecological Risks of Glufosinate ..................................................................113

7 CONSIDERATION OF EXECUTIVE O RDERS, STANDARDS, AND TREATIES RELATING TO ENVIRO NMENTAL IMPACTS.....................................................115
7.1 Executive Orders with Domestic Implications .......................................................115
7.1.1 Executive Order 12898: Environmental Justice .........................................115 7.1.2 Executive Order 13045: Protection of Children .........................................116 7.1.3 Executive Order 13112: Invasive Species ..................................................116 7.1.4 Executive Order 13186: Migratory Birds ...................................................117 7.2 Executive Orders with Inte rnational Implications ..................................................117 7.3 Other Federal Laws .................................................................................................118
7.3.1 Clean Water Act ..........................................................................................119 7.3.2 Clean Air Act ..............................................................................................119 7.3.3 National Historic Preservation Act .............................................................119 7.3.4 Federal Laws Regarding Unique Char acteristics of Geographic Areas .....120

8 LIST OF PREPARERS .................................................................................................121

9 REFERENCES ...............................................................................................................125– iv – APPENDICES
A Mesotrione Description, Uses, and Potential Impacts
B Isoxaflutole Description, Uses, and Potential Impacts
C Glufosinate Description, Uses, and Potential Impacts– v – LIST OF TABLES

Table No. Description Page

2-1 Deregulated Transgenic Soybean Cultivars with Herbicide Tolerance Traits ...........................................................................................9
2-2 Soybean Acreage by State, 2011 and 2012 ................................................11
2-3 Fertilizer Primary Nutrient A pplications to Soybeans in 2006 ..................16
2-4 Insecticide Applicati ons to Soybeans in 20061 .........................................18
2-5 Percent of US Soybean Acres Treated With Herbicides; 1995, 2001, and 2006 .................................................................................23
2-6 Total Applications of Herbicides to Soybeans, 2006 .................................25

2-7 Common Troublesome Weeds in Treated Soybean Fields; 2006-2008 ..................................................................................................26
2-8 US Certified Soybean Acreage by State, 2011 ..........................................35
2-9 World Soybean Production, 2011 ..............................................................54
2-10 World Soybean Exports in 2011/12 ...........................................................55
2-11 Top 10 US Soybean E xport Markets in 2011/2012 Compared to Previous Years .....................................................................55
2-12 US Export Markets for Soybean and Soybean Products (2011) ................56
3-1 Summary of Environmental Consequences and Regulatory Compliance .............................................................................61
4-1 Examples of Crop Rotation Plant-Back Intervals ......................................71
4-2 Maximum Herbicide Application Rates for Herbicide Tolerant Soybean .......................................................................................74
4-3 EIQ Ecological and Overall Field Use Rating of Selected Herbicides ....................................................................................89– vi – LIST OF FIGURES

Figure No. Description Page

2-1 Soybeans Planted Acres in 2010 by County for Selected States ...............12
2-2 Irrigated Soybeans for Beans; Harvested Acres in 2007 ...........................16
2-3 Percent of US Soybean Acres Treated with the 10 Most Used Herbicides; 1995, 2001, and 2006 .............................................................24
2-4 Glyphosate-Resistant Weeds in US Soybean Fields ..................................29
2-5 Return per Acre of Soybeans, 1948-2011 ..................................................53– vii – ACRONYMS AND ABBREVIATIONS

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g Micro g rams p er g ra m A Acre ACHP Advisor y Council on Historic Pro p erties ai Active in g redient AIA Advanced Informed A g reement AMS A g ricultural Marketin g Service ( also USDA-AMS ) AOSCA Association of Official Seed Certif y in g A g encies APHIS Animal and Plant Health Ins p ection Service ( also USDA-APHIS ) ARMS A g ricultural Resource Mana g ement Surve y ARS A g ricultural Research Services ( also USDA-ARS ) ATTRA A pp ro p riate Technolo gy Transfer for Rural Areas BRS Biotechnolo gy Re g ulator y

Servic e C Centi g rade CAA Clean Air Act ( also, Clean Air Act Amendments ) CBD Convention on Biolo g ical Diversit y CE Q Council on Environmental Qualit y CFR Code of Federal Re g ulation s CH 4 Methan e CO Carbon monoxid e CO 2 Carbon dioxid e CODEX Codex Alimentarius Commission CRP Conservation Reserve Pro g ra m CWA Clean Water Act ( formall y , Federal Water Pollution Control Act ) DKN Diketonitrile DNA Deox y ribonucleic acid EA Environmental Assessment EFSA Euro p ean Food Safet y A g enc y EI Q Environmental Im p act Quotient EIS Environmental Im p act Statement EO Executive Order EPA Environmental Protection A g enc y ( also USEPA ) ER Environmental Re p or t ERS Economic Research Service ( also USDA-ERS ) ESA Endan g ered S p ecies Act EPSP 5-enol py ruv y lshikimate 3- p hos p hate ESPS Earl y so y bean p roduction s y ste m EU Euro p ean Union FAO Food and A g riculture Or g anization of the Uni t ed Nations FARRP Food Aller gy Research and Resource Pro g ra m FATUS Forei g n A g ricultural Trade of the United States FAS Forei g n A g ricultural Service ( also USDA-FAS ) FDA Food and Dru g Administration ( also USDHHS-FDA ) FFDCA Federal Food, Dru g , and Cosmetic Act FFP Food, feed, or p rocessin g FIFRA Federal Insecticide, Fun g icide, and Rodenticide Act FIFR A -FEST F Federal Insecticide, Fun g icide, and Rodenticide Act

- Endan g ered S p ecies Task Force fl oz Fluid ounces FONSI Findin g of No Si g nificant Im p act FQPA Food Qualit y Protection Act FR Federal Re g ister– viii – ACRONYMS AND ABBREVIATI ONS (CONTINUED)

FWS Fish and Wildlife Service ( also USFWS ) GHG Greenhouse g ases IMS Information Mana g ement S y ste m IDP Identit y Preservation IPCC Inter g overnmental Panel on Climate Chan g e HPPD p -H y drox yp hen y l py ruvate diox yg enase lb Pound LMO Livin g modified or g anisms LOC Level ( s ) of Concern M g /k g bw Milli g rams p er kilo g ra m of bod y wei g h t MG Maturit y g rou p N 2 O Nitrous oxide NAPPO North American Plant Protection Or g anization NASS National A g ricultural Statistics Service ( also USDA-NASS ) NEPA National Environmental Polic y Act NHPA National Historic Preservation Act NMFS National Marine Fisheries Service NOAEL No observable adverse effect level NOP National Or g anic Pro g ra m NPS Non p oint source NRC National Research Council NRCA Natural Resources Conservation Service ( also USDA-NRCS ) OECD Or g anization for Economic Coo p eration and Develo p ment OTA Or g anic Trade Association PAT Phos p hinothricin acet y ltransferase PIPs Plant-incor p orated p rotectants PM Particulate matter PPA Plant Protection Act PPRA Plant Pest Risk Assessment PRA Pest Risk Anal y sis
p ts p ints SO X Sulfur oxides TSCA Toxic Substances Control Act US United States USACE United States Arm y Cor p s of En g ineers USC United States Code USDA United States De p artment of A g riculture USDHHS United States De p artment of Health and Human Services USEPA United States Environmental Protection A g enc y ( also EPA ) USFWS United States Fish and Wildlife Service ( also FWS ) WHO World Health Or g anization– 1 – 

## 1 PURPOSE AND NEED

This Chapter describes the purpose of and need for determining a nonregulated status for SYHT0H2 soybean, and includes an explanation of the regulatory context of the decision.



### 1.1 Regulatory Authority

"To protect the health and value of American agriculture" is the basic mission of the United States Department of Agriculture (USD A) Animal and Plant Health In spection Service (APHIS). APHIS provides leadership in ensuring the health and ca re of plants and animals. The agency improves agricultural productivity and compet itiveness, and contributes to the national economy and public health. USDA policy states that all methods of agricultural production (resulting in conventional, genetically engineered [transgenic], and organic vari eties) can provide benefits to the environment, consumers, and producers.

Since 1986, the United States govern ment has regulated genetically engineered organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (OSTP 1986) (Coordinated Framework). Th e Coordinated Framework describes the comprehensive federal regulatory policy for ensu ring the safety of biotechnology research and products and explains how federal agencies will use existing federal statutes in a manner that ensures public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of th e 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 stat utory authorities;

2. Agencies are required to focus on the characte ristics and risks of the biotechnology product, not the process by which it is created; and

3. Agencies are mandated to exercise oversight of genetically engineered organisms only when there is evidence of “unreasonable” risk.

The Coordinated Framework explains the regulat ory roles and authorities for the three major federal agencies involved in regulating genetically engineered organisms: APHIS, the US Environmental Protection Agency (EPA), an d the US Food and Drug Administration (FDA). Each agency’s role is described in the following sections.



### 1.1.1 Animal and Plant Health Inspection Service

APHIS regulations at Code of Federal Regulations title 7 part 340 (7 CFR part 340) (USDA 1987), which were promulgated pursuant to authority granted by the Plant Protection Act (PPA), as– 2 – amended, 1 control the introduction (importation, inte rstate movement, or release into the environment) of certain genetically engineered organisms and products. A genetically engineered organism is no longer subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 340 wh en APHIS determines that it is unlikely to pose a plant pest risk. A genetically engineered 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 (Section 340.2) and is also considered a plant pest. A genetically engineered organism is also regulated under 7 CFR part 340 when APHIS has reason to believe that the genetically engineered organism may be a plant pest or APHIS does not have information to determine if the genetically engineered organism is unlikely to pose a plant pest risk.

A person may petition the ag ency that a particular regulated artic le is unlikely to pose a plant pest risk, and, therefore, is no longer regulated u nder the plant pest provisions of the PPA or the regulations at 7 CFR part 34 0. The petitioner is required to provide information under Section 340.6(c)(4) related to plant pest risk th at the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than th e unmodified organism. A genetically engineered organism is no longer s ubject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA wh en APHIS determines that it is unlikely to pose a plant pest risk.

Under the authority of the plant pest provisions of the PPA and 7 CFR part 340, APHIS has issued regulations for the safe developm ent and use of genetically engine ered organisms. As required by Section 340.6, APHIS must respon d to petitioners that request a determination of the regulated status of genetically engineered organisms. Wh en a petition for nonregulated status is submitted, APHIS must make a determ ination if the genetically engineered organism is unlikely to pose a plant pest risk. If APHIS determines based on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organism is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest provisions of the PP A and 7 CFR part 340.



### 1.1.2 Environmental Protection Agency

Under the Federal Insecticide, Fungi cide, and Rodenticide Act 2 (FIFRA), EPA regulates the use of pesticides, including plant-incorporated protectants, requiring registration of a pesticide for a specific use prior to distribution or sale of the pesticide for a proposed use pattern. 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; and manufac turing, storage and disposal practices. Prior to registration for a new use for a new or previously registered pesticide, EPA must determine, through in-depth review of the comprehensive data set submitted by the registrant, that the pesticide will not cause unreasonable adverse effe cts on humans, the environment, and non-target species when used in accordance w ith label instructions. EPA must also approve the pesticide label in accordance with 40 CFR part 1 56. Once registered, a pesticide may not legally be used unless the use is consistent with the approved directions for use on the pesticide's label or labeling. The overall intent of the label and labeling is to provide clear directions for effective product

1 United States Code [USC.] title 7, sections 7701 through 7772 2 7 USC 136 et seq.– 3 – performance while setting strict an d legal limits on use that are within the parameters of an acceptable risk assessment for human health and the environment.

EPA also sets tolerances for residues of pesticides on and in food and animal feed, or establishes an exemption from the requiremen t for a tolerance, under the Federal Food, Drug, and Cosmetic Act 3 (FFDCA) of 1938. EPA is required, before establis hing a pesticide tolerance, to reach a safety determination based on a finding of reasonabl e certainty of no harm under the FFDCA, as amended by the Food Quality Protection Act 4 (FQPA) of 1996. FDA enforces the pesticide tolerances set by EPA.



### 1.1.3 Food and Drug Administration

The FDA regulates genetically engineered organi sms under the authority of the FFDCA. The FDA published its policy statement concerning regulation of products derived from new plant varieties, including those derived from ge netic engineering, in the Fe deral Register on May 29, 1992 5 . Under this policy, FDA implements a voluntary consulta tion process to ensure that human food and animal feed safety issues or other regulatory issues, such as labeling, are resolved before commercial distribution of bioeng ineered 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.



### 1.2 Petition for Determination of Nonregulated Status: Herbicide-Tolerant SYHT0H2 Soybean

Syngenta Biotechnolo gy, Inc. (Syngenta) and Bayer CropS cience AG (Bayer) (collectively, the Petitioners) submitted an initia l Petition (12-215-01p) to APHIS on July 31, 2012 (Sy ngenta 2012a), for determination of nonregulated status for S YHT0H2 herbicide tolerant soybean (hereafter referred to as SYHT0H2 soybean). The Petition was revised in response to APHIS’ request for additional information and resubmitted on September 17, 2012 (Sy ngenta 2012c). APHIS announced that the Petition was available for public comment on February 27, 2013; the public comment period ended on April 29, 2013 (USDA-APHIS 2013b). Nonregulated status woul d include SYHT0H2 soybean, progeny from crosses between SYHT0H2 soybean a nd conventional soybeans, and progeny from crosses of SYHT0H2 soybean wi th other transgenic soybean that has been deregulated. SYHT0H2 soybean is curren tly regulated under the PPA. Intersta te movements and field trials of SYHT0H2 soybean have be en conducted under permits issued or notifications acknowledged by APHIS since 2008. Data resulting from these field tria ls are described in the Petition. This Environmental Report (E R) has been prepared by the Petitioners to pr ovide APHIS with data necessary to complete an en vironmental review of SYHT0H 2 soybean pursuant to the National Environmental Policy Act 6 (NEPA).

3 21 USC 301 et seq

. 4 7 USC 136 et seq

. 5 57 FR 22984 6 42 USC Section 4321 et seq.– 4 – 

### 1.3 Purpose of and Need for Product

The Petitioners have co-developed SYHT0H2 soyb ean, a new cultivar that has been genetically modified to tolerate herbicides that inhibit p -hydroxyphenylpyruvate di oxygenase (HPPD) and glutamine synthetase. Most soybeans currently grow n in the United States are glyphosate-tolerant transgenic varieties. SYHT0H2 soybean is a new cultivar that is tolerant of three herbicides: mesotrione, isoxaflutole, and glufosinate-ammoni um (hereafter, glufosinate). SYHT0H2 soybean will offer growers much-need ed flexibility to use herbicides w ith two alternative modes of action in their weed management progra ms and will help mini mize 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 sequenc e to the native HPPD in common oat ( Avena sativa ). In comparison with the native soybean HPPD, the H PPD isozyme from oat has lower binding affinity for HPPD-inhibiting herbicides, such as me sotrione and isoxaflutole, and confers tolerance to herbicide application rates that would ot herwise 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 inhib itor of glutamine synthetase. Expression of pat confers a glufosinate-tolerance phenotype.

The extensive use of glyphosate-based weed-contr ol 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 re sistant to glyphosate, thus making weed control with glyphosate more difficu lt (Owen 2008). Twenty-four glyphosate-resistant weed species have been identified globally, 14 of which are foun d in the US (Heap 2013d). Cultivation of SYHT0H2 soybean will provide growers with an opportunity to use a glutamine synthetase-inhibitor herbicide (glufosinate) and two HPPD-inhib itor herbicides (mesotrione and isoxaflutole) for control of problematic weeds in soyb ean production systems.

Mesotrione and isoxaflutole are sy stemic, translocated herbicides w ith soil residual activity that are used for pre-emergence and post -emergence control of predominan tly dicot weed species in a number of crops, including corn, which has a natura l tolerance of these herb icides. Glufosinate is a contact herbicide that is applied to crops post-emergence and has no soil residual activity. Glufosinate controls a broad sp ectrum of monocot and dicot we ed species. Glufosinate and mesotrione/isoxaflutole have distinct herbicidal mo des of action, both of whic h differ from that of glyphosate. Using herbicide mixtures and alternati ng herbicides with differ ent modes of action are cornerstones of an integrat ed weed management program. As described in Section 3.2, Preferred Alternative: Determination that SYHT0H2 Soybean is No Longer a Regulated Article , the Petitioners have incorporated a stewardship program in their application that describes methods that growers will be requi red to implement when using SYHT0H2 soybean seed.– 5 – 

### 1.4 Purpose and Need for APHIS Action

As required by 7 CFR §340.6, APHIS must respond to petitioners that request a determination of the regulated status of genetically engineered or ganisms, including transgenic plants such as SYHT0H2 soybean. When a petition for nonregulated status is submitted, APHIS must make a determination if the genetically engineered or ganism is unlikely to pose a plant pest risk.

APHIS will prepare an Enviro nmental Assessment (EA) that will consider the potential environmental effects as part of an agency dete rmination of nonregulated status consistent with NEPA and implementing regulations from the Co uncil on Environmental Quality (CEQ 1978) and APHIS (USDA 2013a, 2013b). This ER has been prepared by the Petitioners in order to specifically evaluate the effects on the quality of the human environment 7 that may result from a determination of deregulated status of SYHT0H2 soybean.



### 1.5 Public Involvement

APHIS routinely seeks public comme nt in connection with petition s to deregulate genetically engineered organisms through notices published in the Federal Register . The Petition for SYHT0H2 soybean was firs t made available on February 27, 2013 for a 60-day pe riod of public review, ending April 29, 2013 . After it has prepared an EA and a PPRA, AP HIS will release both documents for public comment for a period to be specified by APHIS. Timely substa ntive comments received by the agency will be analyzed and used to inform APHIS’ dete rmination decision of the regulated status of SYHT0H2 soybean (i.e., whether or not it presents a plant pest risk), and to assist APHIS in determining whether an Environmental Impact Statement (E IS) is required prior to the determination decision of th e regulated status of this soybean line. This ER will be made available as a matter of public record but APHIS will not solici t public comment on it.



### 1.6 Resources Considered

The list of resources considered in this ER was de veloped in accordance with the requirements of NEPA and consistent with previous APHIS EAs regarding similar products. The evaluation considers potential environmental impacts to res ources 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 ER are listed below.

Soybean Production

o Acreage and areas of soybean production

o Agronomic practices

o Commercial soybean production and uses

o Seed production

7 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the relationship of people with that environment” (40 CFR §1508.14).– 6 – o Raw and processed soybean commodities

o Organic soybean production

o Specialty soybean systems

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– 7 – 

## 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 2000); it was domesticated in China sometime between the 17th and 11th centurie s 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 fee d. They are the most extensivel y 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 2000). The subgenus consists of 12 wild pere nnial species which are indigenous to Australia; West, Central and South Pacific Islands; China; Ru ssia; Japan; Indonesia; Ko rea; Papua New Guinea; the Philippines; and Taiwan (OECD 2000). 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 2000). G. soja is the ancestor of G. max , and grows in fields, he dgerows, 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 (M allory-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 2000). Artificial hybridization is used for cultivar breeding (OECD 2000). Flowers are typically cleistogamous but, in some cultivars and under some conditions, may be chasmogamous and insects may transfer pollen (Chiari et al. 2005; Ahrent and Caviness 1994; Ray et al. 2003; Erickson 1975). Cross pollination is usually le ss than 1 percent under typical agricultural conditions (Caviness 1966; Ray et al. 2003; Yoshimura, Matsuo, and Yasuda 2006) but may be higher in some cultivars, under some clima tic 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 ro w 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 andChina, using various DNA analysis methods (chloroplast DNA, single-sequence repeats, singlenucleotide polymorphism) have detected low levels of the G. max genome in some wild G. soja populations (Kuroda et al. 2009; Ha segawa et al. 1999; Li et al . 2010), attributed to postdomestication 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 nucl ear microsatellite data (Kuroda et al. 2009).

Soybean grows in a symbiotic as sociation with the bacterium Bradyrhizobium japonicum (Kirchner) Jordan, which carries out nitrogen fixa tion within the plant ro ots (Farooq and Vessey– 8 – 2009). Similar to other legumes, s oybeans 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 bact eria are not native to US soils and would not normally be found in these soils, soybeans are freque ntly inoculated with these bacteria prior to planting, especially if soybean has not been gr own in the field for 3 to 5 years (Pedersen 2007).

Soybean seeds will germinate wh en the soil temperat ure reaches 10°C (OEC D 2000). The soybean plant responds strongly to day length in its phas ic development (Hodges an d French 1985; Hymowitz 1990). Soybeans are not frost tolerant, and they do not su rvive freezing winter conditions (OECD 2000). This erect, bushy herbaceous summer annual can reach a height of 5 feet (OECD 2000). Under very dry cond itions, water stress may affect de velopment (Hodges an d French 1985).

In North America, soybeans are clas sified into 13 maturity groups (MGs) based upon the effects of day length on the time to the appearance of fi rst flowers (Hymowitz 1990 ). The MGs for soybean cultivars are based on bands of adaptation that run east-west across the con tinent, 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 part s of the US, most cultivars are indeterminate 8 and have relatively short crop durations; they are classified as MG 000 , MG 00, and MG 0 (Hym owitz 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, 9 have relatively long crop durations, and are classified in MG IX and MG X (Hod ges and French 1985; He lsel 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 resi stance and herbicide tolerance to modern soybean varieties. 10 In 2012, approximately 93 percent of soybean acreage was planted with transgenic varieties, virtually all being herbicide tolera nt (USDA-NASS 2012b). Transgenic soybean cultivars representing 17 different transformation events have been granted nonregulated status by APHIS (USDA-APHIS 2013a). Eleven of th ese cultivars are tolerant to herb icides, as listed in Table 2-1.

Several of these products have transgenic traits in addition to herbicide tolerance: Monsanto’s MON 87705 soybean, for example, also has an improved fatty acid profile. Other soybean products with herbicide tolerance cu rrently under review by APHIS are:

 BASF Plant Science BPS-CV127-9, which is imidazolinone tolerant;

 Bayer CropScience MST-FGØ72-2, which is glyphosate and isoxaflutole tolerant;

 Dow AgroSciences DAS-444Ø6-6, which is 2,4 -D, glyphosate, and glufosinate tolerant;

 Dow AgroSciences DAS-68416-4, which is 2,4-D and glufosinate tolerant; and

 Monsanto MON 87708, which is dicamba tolerant.

8 A growth characteristic by which a plant’s roots or meristem shoot can keep growing as long as it is alive. 9 A growth characteristic by which the plant stops growing after it r eaches a certain size. 10 Some varieties of soybeans were developed through selection to display nontransgenic tolerance of certain herbicides.– 9 – Table 2-1 Deregulated Transgenic Soybean Cu ltivars with Herbicide Tolerance Traits

Cultivar 1 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 AgrEvo 2 / petition 96-068-01p Phosphinothricin 3 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
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 a nd acreages of soybean productio n in the US, current agronomic practices, specialty production systems, raw an d 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). Acr eage expanded through the 1990s as federal farm program changes increased planting flexibility and encouraged more farmers to incorporate the crop in their rotations (U SDA-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 r ecord (USDA-NASS 2012b). Total harvested acreage in 2012 was estimated to be 76.1 million acres (USDA-NASS 2013a), equivalent to the planted acrea ge, also the third highest on re cord, 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 2013b), down slightly from 2012 but the fourth highest on record. Planted area is projected to be down across the Great Pl ains with the exception of North Dakota. The largest declines are expected in Nebraska a nd Minnesota, while Illinois and North Dakota are expecting the largest increases.– 10 – Fluctuations in soybean acreage are due to environmental, agronomic, and economic factors, as well as programs such as the USDA Conservati on Reserve Program (CRP) or ethanol mandates imposed by the US government, which drive acreage into source cr ops for ethanol.

Growth in the US soybean industry could slow ove r 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 th rough 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 ag ricultural production (USEPA 2007). In the 2007 Census of Agriculture, 11 the USDA Economic Research Servi ce estimated that only 4.1 percent of US cropland was idle (USDA-NASS 2009). To satisfy greater soybean demand, additional soybean acreage is generally planted at the expens e of alternative crops, su ch as cotton or hay, with minor contributions from land exiting CRP agreements (O’Donoghue et al. 2011) resulting in a decrease in total US agri cultural 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 s oybean acreage is con centrated in the upper Midwest (USDA-ERS 2010a), between 35 and 45 degrees north latitude (Hymowitz 1970). Figure 2-1 depicts the soybean pl anted acreage by county in selected states based on 2010 data .

Soybean yield varies by region a nd variety. Soybean yields range fr om 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 pe rform 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.

11 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 fu ture date. It is therefore not available for this report.– 11 – Table 2-2 Soybean Acreage by State, 2011 and 2012

State Acres Planted (thousands)
2011 2012

Alabama 300 330
A r kansas 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 Dako t a 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 ha ve economic or environmental benefits. Cropping practices include planting cover crops, rotating cr ops, and using a variety of tillage techniques to maximize yield, control weeds or other pests, a nd minimize environmental impacts. Other agronomic practices include supplemental irri gation and pest (insect, disease, and weed) management. Proper seedbed preparation, appropriate va riety selection, appropriate planti ng dates and plant population, and good integrated pest management practices are im portant for optimizing the yield potential and economic returns of soybean. While agronomic pract ices may be dependent on the soybean maturity group and variety cultivated, common management strategies are shared across regions.

In this ER, conventional farming is defined as a ny farming system where synthetic pesticides or fertilizers may be used. Conventiona l farming covers a broad scope of farming practices, such as occasional use to regular inputs of synthetic pestic ides and fertilizers. Give n that most soybeans planted in the US are transgenic, conventional fa rming 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.– 12 – Figure 2-1 Soybeans Plan ted Acres in 2010 by Co unty for Selected States

As described in Section 2.1, soybean varieties in specific maturity groups are developed and adapted to certain geographical zones (Hel sel 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 herbicid e-tolerant soybean varieties is attributed to simplified herbicide application practices and positive contributions to productivity and yield (Carpenter and Gianessi 1999; Fernandez-Co rnejo and McBride 2000). Among the various genetically engineered herbicide-tolerant soybean varieties commercially available, glyphosatetolerant varieties represent the vast majority th at are planted in US soybean fields (NRC 2010).



### 2.2.2.1 Cropping Practices
Although the US Midwest is referre d to as the Corn Belt, soybeans are commonly planted in this region as well. Rotating corn with soybean supplies the biodiversit y, nutrients, and ideal temporal sequence that make corn agriculture successful (Gardner and Payne 2003). Other soybean cropping practices that directly or indirectly benefit bot h soybeans and corn include cover crops and tillage and planting techniques.– 13 – 

### Crop Rotation
Soybean crop rotation can improve yield and prof itability over time, control weeds, break disease cycles, limit insect and other pest infestations, prov ide an alternative source of nitrogen, reduce soil erosion, increase soil or ganic matter, improve soil tilth, limit th e potential for weeds to develop tolerance to herbicides, and reduce runoff of nutr ients and chemicals, as well as the potential for contamination of surface water (Al-Kaisi, Hanna, and Tidman 2003). Crop ro tation also affects the densities of soilborne pathogens and antagonistic microorganisms (Garbe va, van Veen, and van Elsas 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 cr ops in rotation with soybean are wheat, cott on, rice, and sorghum. Minor rotational crops that follow soybean producti on include barley, oats, a nd dry beans. The crop rotation sequence can be m odified to take adva ntage of a particul ar economic or ma rket opportunity.

Approximately 15 percent of the soybean acreage is in continuous (i.e., non-rotation) soybean production, a practice that is di scouraged by most soybean spec ialists (Quinby et al. 2006). Planting soybeans after soybeans each year increases the incidence of diseases, nematodes, soil insects, and possibly herbicide residues (Al-Kaisi, Hanna, and Tidman 2003 ; Whitaker et al. 2010). The result is generally decreased yiel ds or increased production costs.



### Cover Crops
Using cover crops in a so ybean 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 increase d soybean yield. Cover crops may be grown in the soybean off-season or simultane ously for managing weeds (Mischler et al. 2010) by competing for limited resources such as su nlight and nutrients, and by suppressing weed emergence when mulched. In the Corn Belt, cove r crops are used on approximately 10 percent of soybean fields; winter wheat, cereal rye, and oats ar e the species most used (Heatherly et al. 2009).



### Tillage and Planting Techniques
Prior to planting, soil must be st ripped of weeds that would otherwis e 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, Blaine, and Poston 2003) and reincorporating crop residue into the soil. Crop resi dues are materials left in a fiel d 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 wa ter-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 percen t 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 empl oys methods that disturb soil less and leave more crop residues on the surface (at least 30 percent), wherea s no-till farming only disturbs th e 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– 14 – quality. Conservation tillage also conserves fuel and water, but may rely heav ily 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-t ill farming has increased more than an y 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 su rvey conducted in 1997, it was found that farmers already using no-till practic es were more likely to adopt herbicide-tolerant soybeans as an effective weed control practic e than farmers using conv entional tillage techniqu es, although th e study also found that the commercializa tion of herbicide-tolerant soybean did not itself encourag e the adoption of no-till practices (Fernandez-Co rnejo and McBride 2000). A subse quent survey conducted between 1996 and 2001 found that grow ers using herbicid e-tolerant seed varieties were more likely to use conservation tillage practices ov er conventional me thods and to practice cons ervation tillage to a greater degree than growers that did not use herbic ide-tolerant crops (Fawce tt and Towery 2002). A survey of 1,195 producers under taken between November 2005 a nd January 2006 revealed that 25 percent of farmers that had been using conventi onal tillage swit ched to no-til l and 31 percent switched to reduced-till af ter adopting glyphosate-tol erant genetically engineer ed crops (Givens et al. 2009). According to the USDA Agricultural Resource Manage ment 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 incr easing over time (USD A-ERS 2012d). USDA data indicate that soybean fields, 93 percent of whic h are planted with herbicide tolerant transgenic varieties, exhibit the highest rate of no-till ad option of major crops, incr easing from 35 to 45 percent between 2002 and 200 6 (the latest data avai lable) (USDA-ERS 2013a).

In summary, the trend of increasing adoption of c onservation tillage pract ices by US soybean growers continued following the introduction of glypho sate-tolerant soybean in 1996. Conservation tillage adoption faci litates broad-spectrum herbicide use, due to the capacity of th ese herbicides to control a variety of weed popu lations prior to pl anting a crop. Though th e causality between herbicide-tolerant soyb ean adoption and conserva tion tillage may be debated (Fernandez-Cornejo, Klotz-Ingram, and Jans 2002), most evidence suggest s a relationship between grower adoption of herbicide-tolerant cr ops and conservation tillage (NRC 2010).

Soybean planting techniques commonly include row spacings of 36 inches (OECD 2000). 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 effi ciency of the nodulated root system. Other co nsiderations 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 stat es, 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.– 15 –  The early soybean production system (ESPS) cons ists of planting an early-maturing soybean variety 4 to 6 weeks before common late-mat uring varieties to reduc e the risk of drought stress that often occurs duri ng July through September in S outhern US states (McPherson, Wells, and Bundy 2001; Whitaker et al. 2010). Early planting also helps avoid harvesting the crop during excessively we t conditions that can occur during the fall.



### 2.2.2.2 Irrigation
The general water requirement for a high-yieldi ng soybean crop (40 to 50 bushels per acre) is approximately 20 to 25 inches of water duri ng the growing season (UA 2006). Irrigation can alleviate the effects of drought stress, which is th e most damaging abiotic stre ss 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 abou t 5 to 50 bushels per ac re (Whitaker et al. 2010 ). Timely irrigation can stabilize soybean yiel ds at 45 to 50 bushels per acre or more, and improve averag e yields about 20 bushels per acre (Wh itaker et al. 2010).

Irrigated soybean systems are the most productive in the US, providing cons istent 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-wh eat 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). Th is 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 cr op in the US is irrigated (USD A-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 Resour ce Regions, with soybean farm s in the states of Nebraska, Arkansas, Mississippi, Missouri, and Kansas accoun ting for 85 percent of all irrigated acres (USDA-NASS 2010). The soils and cl imate in the Eastern, Midweste rn, and portions of the Great Plains region of the US provide sufficient water supplies unde r normal climatic conditions to produce a soybean crop.– 16 – Figure 2-2 Irrigated Soybeans fo r 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 2012 g). A 2006 survey of 19 states (USDA-NASS 2007) found that nitrogen, phosphate, potash, and sulfur were ap plied to soybeans as summarized in Table 2-3.

Table 2-3 Fertilizer Primary Nutrient Applications to So ybeans 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, Illinoi s, Indiana, Iowa, Kansas, Kentucky, Loui siana, Michigan, Minnesota, Mississippi, Misso uri, Nebraska, North Carolina, North Dakota, Ohio, South Dakota, Tenness ee, Virginia, and Wisconsin; totaling 72.9 million acres.– 17 – Soybeans may remove up to 70 pounds of nitroge n 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 cr op 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 soyb ean, nodulating bacteria inoculants are often applied to soybean seeds just before planting (Beuerlein 2005).



### 2.2.2.4 Management of Insects
US soybean fields ge nerally face little economic pest pressure fr om insects, due in large part to the capacity of soybeans to experience limited insect he rbivory 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 per cent of US soybean acres were treated with insecticides (Gianessi 2009). However, since th e 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. Inse ct pests are capable of severely damaging soybeans through defoliation and pod ea ting (Whitaker et al. 2010). The soybean aphid eats stems; heavy infestations of this pest ha ve 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 practic ally 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 b eetle (Gianessi 2009). Insects which attack the pods are the major reason for treating s oybeans 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 c onsistent, economical, and effective suppression of insect outbreaks on so ybean (Gianessi 2009); and

 Trap cropping has been proven to be a cost effe ctive means of managing insects in soybeans (Whitaker et al. 2010). Soybean field borders ar e planted using a soybean variety at least two maturity groups earlier than the re st 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 establishe d to indicate when insecticide applications are necessary (Higgins 1997). The th resholds are commonly based on number of in sects found in field– 18 – sampling surveys and/or in established standard defo liation thresholds, such as those provided by the National Information System of the Regional Integrated Pest Management Centers in pest management strategic pl ans (USDA-NIFA 2012).

Table 2-4 presents summary data of the latest available chemical in secticide usage statistics for US soybeans from a 2006 surv ey (USDA-NASS 2007). The survey found th at insecticides were applied to 16 percent of the 72.9 million soybean ac res 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-cyhal othrin, chlorpyrifos, and esfenvalerate) were applied to 6 percen t, 5 percent, and 3 percent of the planted acres, resp ectively (USDA-NASS 2007).

Table 2-4 Insecticide Applicat ions to Soybeans in 2006 1

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 0.003Lambdacyhalothrin 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 (Carpent er 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 )– 19 –  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 prev ented or managed by planting disease resistant cultivars. Besides selecting cultivars with resistance to diseases prev alent in a grower’s par ticular region (Dorrance, Draper, and Hershman 2007), a healthy soybean crop st arts 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 nutrien ts and water to grow healthy plants (Nelson 2011). Tillage practices can also affect disease ri sk: no-till soils may have higher soil moisture and lower soil temperatures than coul d increase risk. Tilling may improv e 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 de spite taking such measures, f ungicides are used (Jardine 1997; Padgett, Schneider, and Hollier 2011). The most commonly applied fungicides on soybean (azoxystrobin, propiconazole, pyraclostrobin, tebuconaz ole, and trifloxystrobin) were applie d to only 4 percent of the planted soybean acreage in the 19 states surveyed in 2 006 (USDA-NASS 2007). Of these fungicides, pyracl ostrobin and azoxystrob in were the only two applied on more than 0.5 percent of the planted acres. Pyracl ostrobin was applied to 2 percent of the pl anted acres at an average rate of 0.112 lb/A per year, wherea s azoxystrobin was applied to 1 percent of pl anted acres at an average rate of 0.106 lb /A per year (USDA-NASS 2007).– 20 – Some varieties of soybeans are more susceptible to certain bacterial or viral diseases than others, and resistant varieties are marketed as such (IS UE 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 th ese insects, as described in Section 2.2.2.4, Management of Insects , and therefore minimize disease tr ansmittal from these vectors. Some diseases may be transmitted in or on seeds; fu ngicide-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 drastically decrease crop yield and quality (Car penter 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 ha rvest equipment (Loux et al. 2008). Soybean yield losses can range from 12 to 80 percent if weed s are uncontrolled for an entire season (Barrentine 1989; Dalley, Renner, and Kells undated).

If weeds are left uncontrolled, soybean cannot be grown economically (Buhler and Hartzler 2004). Growers make choices to use certa in herbicides based on weed, inse ct and disease pressures, cost of seed and other inputs, technolo gy fees, fuel costs, worker safe ty, potential for crop injury, and ease and flexibility of the system (Gianessi 20 05). Glyphosate-tolerant soybeans have allowed growers to use a broad sp ectrum herbicide, glyphosate, in pl ace 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 Herbic ide discussion below.

The primary factors affecting soybean yield loss from weed competition ar e the species, density, and the duration and time period of the competiti on. The later the weeds emerge, the less impact the weeds will have on yield. Soybean plants w ithstand 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 th e 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 s oybean (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 w eed 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– 21 – seeds were found to range from 4,100 to 137,700 s eeds per square meter of soil (May and Wilson 2006). Climate, soil characteristics, cultivation, cr op selection, and weed management practices affect the seed bank composition and size.

Soybean growers can use a variet y 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 c ontrolled 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 (Dur gan and Gunsolus 2003; Green and Martin 1996) that are not controlled by lim ited-tillage practices. Winter perennial weeds are particularly competitive and difficult to cont rol, as these weeds regrow every year from rhizomes or root systems. Recen t surveys of US agronomic crop producers suggest that pigweed species ( Amaranthus spp.), morning glory species, Jo hnsongrass, ragweed species ( Ambrosia spp.), foxtail species, and velvetleaf are among the mo st 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 cont rol (Loux et al. 2008). Crop rotati on 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 comp etitive crops that prevent weed establishment. However, crop rotation is not effective against s eedbanks for all weed species (Jordan et al. 1995).

Soybeans planted in narrow rows, 15 inches or less wide, may have benefi ts such as higher yield potential and increased crop competitiveness with weeds (D alley, Renner, and Kells undated). Planting crops in narrow rows in creases the amount of shading by the crop cano py, 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 cont rol of weeds in soybean that cultivators cannot reach (Byrd, Blaine, and Poston 2003). Often the combination of shallow, flat cultivation with directed herbicide sprays is the least expensive a nd most effective weed treatment. Herbicides are applied at various points of the gr owing season (Carpenter et al. 2002):

 Pre-plant (during field preparation);

 Pre-emergence (during or imme diately after planting); and

 Post-emergence (during crop growth).– 22 – A traditional soybean weed control program in cludes a pre-emergence herbicide application followed by one or more post-em ergence applications about 4 to 6 weeks after the crop has emerged (Byrd, Blaine, and Poston 2003). Yield lo sses from weed compe tition may occur when herbicide application is delayed (Dalley, Renner, and Kells 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. 201 0). In selecting an herbicide, a grower must also consider whether an herbicide can legally be used on the crop (herbicide s 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 cr op, residual effects that can limit crops that can be grown in rotation, effectiveness on expected we eds, 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 plan t physiology (i.e., modes of action) to affect the health of a given plant and are active at one or mo re target sites within a plant (Prather, DiTomaso, and Holt 2000). Target sites are enzymes, proteins, or places in the plant where herbicides bind and thereby disrupt normal plant fu nctions. Some common modes of herbicide action include auxin growth regulators, amino acid inhibitors, chlorophyll pigment inhibitors, lipid biosynthesis inhibitors, and glutamine syntha se inhibitors (UW undated).

By the early 1990s, there were over 70 individual herbicides or co mbination products registered for weed control in soybean (Byrd, Blaine, and Poston 2003). At that time, pre-emergence herbicides commonly used on soybean were 2,4-dichloropheno xy acetic acid (2,4-D), chlorimuron, metolachlor, metrib uzin, pendimethalin, and trifluralin. Co mmonly used soybean post-emergence herbicides included acif luorfen, basagran, bentazo n, clethodim, cloransulam, fluazifop, fomesafen, glyphosate, imazethapyr, quizalofop, and sethoxydim. These he rbicides typically control either broadleaf or grass species, but ra rely both. Several spec ies of weeds are usually present in any particular field and growers need to control both gr assy and broadleaf we eds using different herbicides (Carpenter et al. 2002). A combination of herbicid es may be necessar y, but tank mixing some herbicides can resu lt in antagonism betw een the compounds. Sequen tial spraying may be required, in some cases necessitating multipl e passes to apply the different herbicides.

Table 2-5 lists the most commonly applied herb icides 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) 12 . Figure 2-3 graphs the usage trends of the top 10 herbicides from 1995 in terms of percent planted acres tr eated 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 al so that the number of acres to which other herbicides were a pplied significantly declined (NRC 2010).

12 USDA-NASS no longer collects these data.– 23 – Table 2-5 Percent of US Soybean Acres 1 Treated With Herbicides; 1995, 2001, and 2006

Herbicide Percent Soybean Acres Treated per Year Percent Soybean Acres Treated per Year
1995 2001 2006 Herbicide 1995 2001 2006 2,4-D 2 10 4 3 Glyphosate 20 73 92 2,4-DB 3 1 <1 <1 Imazaquin 15 2 1 Acifluorfen 12 3 <1 Imazethapyr 44 9 3
Alachlor 4 <1 <1 Lactofen 5 1 <1
Bentazon 12 1 <1 Linuron 2 -- -- Chlorimuron-ethyl 16 5 4 Metolachlor, ( S )Metolachlor 7 <1 --

Clethodim 5 4 3 Metribuzin 11 2 2 Clomazone 4 <1 -- Paraquat 2 -- 1
Dimethenamid 1 -- -- Pendimethalin 26 10 3
Ethalfluralin 1 -- -- Quizalofop-ethyl 6 <1 <1 Fenoxaprop-ethyl 6 3 <1 Sethoxydim 7 1 <1 Fluazifop-P-butyl 10 3 1 Thifensulfuron 12 2 1
Flumetsulam 2 <1 <1 Trifluralin 20 7 2
Fomesafen 4 7 2
Sources: (USDA-NASS 1996, 2002, 2007) 1- Survey states: 1995: Arkansas, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesot a, Mississippi, Missouri, Nebraska, North Caroli na, Ohio, and Tennessee. 2001: Arkansas, Illinois, Indiana, Iowa, Minnesota, Missouri, Nebraska, and Ohio. 2006: Arkansas, Illinois, Indiana, Iowa, Ka nsas, Kentucky, Louisiana, Michigan, Minne sota, Mississippi, Missouri, Nebraska, Nor th Carolina, North Dakota, Ohio, South Dakot a, Tennessee, Virginia, and Wisconsin. 2012: Alabama, Arkansas, Georgia, Illinois, Indiana, Iowa, Kans as, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Misso uri, Nebraska, North Carolina, North Dakota, Ohio, Pennsylvani a, 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.

While total herbicide use trends are subject to debate , it is clear that an herbicide-substitution effect has occurred in US soybean pr oduction (Benbrook 2009; Ferna ndez-Cornejo et al. 2009). With the 1996 commercial introduction of glyphosate-tolerant soybean, a major shift occurred with an increased use of glyphosate fo r 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 activ e ingredient in a broadspectrum Roundup® herbicide intr oduced by Monsanto in 1974 (Monsanto 2005). It works by disrupting the 5-enolpyru vylshikimate 3-phosphate (EPSP) synthase enzyme, which is involved in the production of am ino acids that are essentia l to plant growt h. Glyphosate produc ts are among the world’s most widely used herbicides.– 24 – Figure 2-3 Percent of US So ybean Acres Treated with th e 10 Most Used Herbicides; 1995, 2001, and 2006 1

Source: (USDA-NASS 2007) 1- Survey states: 1995: Arkansas, Georgia, Illinoi s, Indiana, Iowa, Kentucky, Louisiana, Minnes ota, Mississippi, Missouri, Nebraska, North Carol ina, Ohio, and Tennessee. 2001: Arkansas, Illinois, Indiana, Iowa, Minnesota, Missouri, Nebraska, and Ohio. 2006: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Mi nnesota, Mississippi, Missouri, Nebraska, No rth Carolina, North Dakota, Ohio, South Dakot a, Tennessee, Virginia, and Wisconsin.

In 2006 (the latest year for which data are av ailable), 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 tr oublesome weeds in herbicide-treated soybean fields in 2006, 2007, an d 2008, and the number of acres treated with herbicides each year.– 25 – Table 2-6 Total Applications of Herbicides to Soybeans, 2006 1

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, sodiu m <0.5 1.0 0.287 0.296 47 Alachlor <0.5 1.0 1.931 1.931 485
Bentazo n <0.5 1.0 0.687 0.687 70 Carfentrazone-ethy l <0.5 1.2 0.038 0.046 10 Chlorimuron-ethyl 4 1.0 0.017 0.017 52 Clethodi m 3 1.1 0.096 0.102 190 Cloransula m -methy l 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- b uty l 1 1.0 0.099 0.099 43 Flufenacet <0.5 1.0 0.265 0.265 80 Flumetsula m

<0.5 1.0 0.048 0.048 8 Flumiclorac-penty l 1 1.4 0.020 0.028 17 Flumioxazin 3 1.0 0.066 0.066 138 Fomesafe n 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 sal t 92 1.7 0.802 1.330 88,903
Imazamo x <0.5 1.0 0.030 0.030 9 Imazaquin 1 1.0 0.061 0.062 66 Imazethapy r 3 1.0 0.053 0.053 100 Imazethapyr, ammo n iu m <0.5 1.0 0.048 0.048 5 Lactofen <0.5 1.0 0.110 0.110 23 ( S )-Metolachlo r 1 1.0 1.023 1.023 837 Metribuzi n 2 1.0 0.255 0.260 437 Paraquat 1 1.0 0.492 0.511 335 Pendimethali n 3 1.0 0.920 0.926 1,894 Quizalofop-P-ethy l <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 Tribenuro n -methy l 1 1.0 0.008 0.008 5 Triflurali n 2 1.0 0.818 0.818 1,454
Source: (USDA-NASS 2007) 1- Survey States: Arkansas, Illinois, Indi ana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, N ebraska, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Vi rginia, and Wisconsin; totaling 72.9 million planted acres.– 26 – 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 N ightshade, 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)– 27 – 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, Carpenter, and McHughen 2012).

The diversity of herbicides available to US soybea n 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 genera lly decreased, as indicated in Figure 2-3 and Table 2-5. However, total herbicide use may not be an effec tive metric to measure environmental impact, as this does not effectivel y 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 indi cating a decline in herbicide use in the early years of herbicidetolerant crop production (Carpenter et al. 2002) th at some argue was then followed by an increase in the volume of herbicide usage as the t echnology spread (Benbrook 2009). Others report a continuing decline in herbicide use with the ad option 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). Th e contradictory findings have been attributed to the different measurement a pproaches 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

Herbicide resistance is generally defined by the Weed Science Society of America (WSSA) 13 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, re sistance may be naturally occurring or induced by such techniques as genetic engineering or selec tion 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 selec ting an herbicide-resistant plant (Boerboom and Owen 2006) from a popula tion of a weed species. WSSA defines herbicide tolerance as “the inherent ability of a species to survive and repr oduce after herbicide treatme nt. This implies that there was no selection or genetic manipulation to make the plant to lerant; 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 tole rance has been observed in weed species such as waterhemp, common cocklebur, Powell amaranth, ragweed (c ommon and giant), and kochia (Carpenter et al. 2002).

Herbicides do not cause the mutati ons that result in weeds developing resi stance. Rather, an extremely rare genetic trait that allows a weed to survive any given herbicide may exist in the natural population. That gene is mo re likely to be found an d increase in occurrence when one he rbicide is used frequently. Repeated use of that herbicide wi ll expose the weed populati on to selection pressure that may lead to an in crease in the number of surviving resistant indi viduals in the population

13 www.wssa.net– 28 – (HRAC 2011). In other words, plants susceptible to the applied herbicide will die or have decreased reproduction; those few having some type of natura l resistance will surviv e 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).

The reproductive biology of the particular weed sp ecies appears to be a factor contributing to the spread of resistant biotypes. For exampl e, 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 Sout h. Other species such as common ragweed ( Ambrosia artemisiifolia ) produce seeds that do not have fe atures that allo w for such easy distribution by the wind. As a cons equence, 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, 2013) ( D. Lingenfelter in, vogel, 2012) not http://magissues.farmprogress.com/AMA/AM 02Feb12/ama020.pdf (Lingenfelter 2011).

The risk of weeds developing resist ance to herbicides a nd the potential impact of resistance on the usefulness of an herbic ide varies greatly across different modes of action and depends on a combination of factors includin g selection pressure, herbicide soil residua l activity, herbicide chemistry, the rate of seed production, and the level of genetic variati on in plants. Another major factor contributing to the development of he rbicide-resistant weeds is poor weed control management practices by the grower s. These include application of herbicides at rates below those indicated on the EPA-approved label for the weed sp ecies and reliance on a single herbicid e for weed control without the use of other cu ltural control methods (i.e., pre- plant and in-crop tillage) (Peterson et al. 2007). Weed management pr ograms that integrate th e use of herbicides wi th different modes of action and short residual activity times in soil re duce selection pressure (P rather, DiTomaso, and Holt 2000). Growers have been succes sfully managing herbic ide-resistant weeds for decades by using alternative herbicides an d/or cultural meth ods such as tillage or crop rotation (especially to incorporate herbicide mode of action rotation). The occurrence of an herbicide-resistant weed biotype generally does not end the useful lifespan or preclude the effective use of the herbicide in question as part of an overall we ed management system.

Globally, 397 weed biotypes have developed resi stance to 21 herbicide modes of action (Heap 2013a). In the US, 142 weed biotypes have devel oped resistance to herbic ides. Some populations of certain weed species have developed resist ance to multiple herbicid e classes (Boerboom and Owen 2006). For example, some tall waterhemp plan ts are known to be resi stant to up to four herbicide modes of action (McMullan and Green 2011; Tranel 2010). Most herbicides affect a single specific site of action, and that site is usually under the control of a si ngle gene, or at most a few genes. Annual weeds are more likely to e volve 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 acr es 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-resi stant weed biotypes in US s oybean fields vary by state (Figure 2-4). Each of these species is generally controlled by mesotr ione, isoxaflutole, or glufosinate except hairy fleabane, Italian ryegra ss, and rigid ryegrass (Syngenta 2012c), which are not, however, typically problematic in soybean fields (see Table 2-7, Common Troublesome Weeds– 29 – in Treated Soybean Fields, 2006-2008 ). Other herbicides are availabl e to control these species, and could be appropriately used in an integrated weed management program. Figure 2-4 Glyphosate-Resistant Weeds in US Soybean Fields

Source: (Heap 2013d) Note that presence of a populati on is unrelated to prevalence. * indicates at least one population in that state posse sses resistance to glyphosate and another herbicide. **indicates at least one population in that state possesse s resistance to glyphosate and two other herbicides.

All of the weed species that are resistant to glyp hosate are fully or partially controlled by one or more of the herbicides to whic h 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 isoxaflutol e) or glufosinate when applied to the weed postemergence:

 Certain common waterhemp ( Amaranthus tuberculatus ( syn. rudis )) populations have evolved resistance to post emergence applicat ions of HPPD-inhibiti ng herbicides including mesotrione and isoxaflutole in US fields wher e 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 inhi bitors (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 resistan ce to these herb icides occurred during a time of less dive rsity in herbicide usage an d cultural practices. In an Illinois biotype of common waterhemp found to be resist ant in 2009, for exam ple, an absence of crop rotation and herbicide rotatio n, and failure to use mixed products containi ng multiple modes of herbicidal action– 30 – in a corn seed producti on field contribute d to the deve lopment of HPPD-inh ibitor resistance (Hauseman et al, 2011). Crop mana gement practices in seed co rn production fields are not representative of fields in which corn hybrids or soybean varieties ar e 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 providi ng full, effective season-long weed control, could delay or mitigate he rbicide resistance in Palmer amaranth, for ex ample, for at least 20 years (Neve et al. 2011b).



### Transgenic Crops for Herbicide Tolerance
Herbicide-tolerant soybean was in troduced 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 develope d through conventional and mutation breeding, with biotechnology adding transgenic traits (C arpenter 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 tole rance to glyphosate had not been successful. The first transgenic traits put into soybean were he rbicide 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, Price, and Fern andez-Cornejo 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 usi ng multiple herbicides (Carpenter et al. 2002). However, using a single broad-spectrum herbicide intensifies selecti on 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).



### 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 pur ity, vigor, and presence of weed seed, seed- borne diseases, and inert materials such as dirt) is a major factor in crop yi elds. If variability in seed production is not carefully controlled, the value of a new variety or cultivar may be lost (Hartmann, Kester, and Davies 2011). Genetic purity in commercial se ed 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.– 31 – Seed laws and certification agenci es ensure that purchasers who receive certified seed can be assured that the seed meets established s eed quality standards (Bradford 2006). The US Federal Seed Act of 1939 14 recognizes seed certification and offi cial certifying agencies. Implementing regulations further recognize land history, field is olation, and varietal purity standards. Soybean seed is commonly separated into three classe s: Foundation, Registered, and Certified (MCIA 2012). Each class of seed is identified to designa te the seed generation from the original breeder source (Hartmann, Kester, and Davies 2011).

Foundation, Registered, and Certified seed pr oduction is controlled by public or private certification programs (AOSCA 2003) . Commercially certified soybea n seed must meet state and Federal seed standards and labeling requirements. State seed certification standards vary slightly from state to state and ca n be more restrictive than the seed st andards of the Association of Official Seed Certifying Agencies (AOSCA). All soybean seed sold may not be officially certified; however, commercial soybean seed sold and pl anted 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 an d 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 fo r a variety of uses and meal for human dietary products and livestock fee d. Soybean is the most extensively grown oilseed in the world, with approximatel y 210 million metric tons of harv ested seed produced in 2009, representing 56 percent of world oilseed producti on (Soystats 2012a). Unpr ocessed soybeans have no human food and limited animal fe ed use since they contain anti-nut rient factors, such as trypsin inhibitors and lectins. Adequate heat processing inactivates these factors.

Approximately 85 percent of the world soybean s eed supply is crushed to produce soybean meal and oil (Soyatech 2012). The first modern US soybean production fa cility was established in 1922, 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 ve getable 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 to p 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 a bout 21.8 kilograms of protein-rich meal and 5.0 kilograms of oil (OECD 2001). Soybean oil ma kes up 94 percent of the soybean food ingredients consumed by humans (OECD 2001). Th e 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 2000).

14 7 USC 1551.– 32 – A significant fraction of the soybean market is dedicated to production of purified oil for food use and industrial applications (Cah oon 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 (Soystats 2 010; USSEC 2006). Soybean oil industrial uses include plastics, lubricants, coatings, printing inks and adhesives, emulsifiers, surfactants (industrial detergents and cleaners as well as solvents), resins, and biodiesel, among others. Soybean is also a carbon/nitrogen source in th e production of yeasts via fermentation (Cahoon 2003). Soy-based industrial oil products have ma ny advantages compared to petroleum oils, including being inherently biodegradable, ha ving 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, be ef, poultry, dairy, and fish ) and human food protein (CAST 2009). Tofu, soy milk, so y sauce, miso, meat substitute s, protein powder, soynuts, soy sprouts, baked or roasted soybeans, and soy flou r 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 pe rcent going to poultry, 32 percent to swine, and 9 percent each going to dairy and b eef cattle feed, respectively. About 2 percent is used in pet food (OECD 2001).

Although honeybees have been repo rted 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 produ ced using specific methods a nd certified under the USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organ ic” (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 procedur es by which the product is produced. The NOP was established by the Organic Foods Production Act of 1990 15 and implementing USDA regulations (USDA 2012).

Organic production operators must develop and maintain an organi c system plan approved by an accredited certifying agent (USDA 2012). 16 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 cropl and must be managed organically for a minimum of 36 months (USDA 2012) 17 . The NOP requires organic farming operations to have distinct, defined boundaries and buffer zones to prevent unintended contact w ith excluded methods from adjoining land that is

15 Title 21 of Public Law 101-624, the Food, Agriculture, Conservation, and Trade Act of 1990 , as amended. 16 Section 201 17 Section 205.202(b)– 33 – not under organic management (USDA 2012) 18 . The NOP regulations preclude the use of excluded methods in crop production. Excluded meth ods are defined at 7 CFR §205.2 as:

“A variety of methods used to genetically m odify organisms or infl uence 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 tech nology). Such methods do not include the use of traditional breeding, conjugation, fermen tation, hybridization, in vitro fertilization, or tissue culture.”

Use of synthetic insecticides, fe rtilizers, and transgenic crops is excluded from certified organic production systems. Natural products are allowed. Sin ce 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 engin eered materials in an or ganic-labeled product. The unintentional presence of the products of excl uded 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 produc ts of excluded methods as detailed in their approved organic system plan (Ronal d 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 organi c 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 be tween the fields (Sundstrom et al. 2002; NCAT 2003; Bradford 2006; Baier 2008). Is olation distances vary between crops based on the type of pollination. Isolation distances for soybean ar e usually not required because the crop is predominantly self-pollinated; however, as desc ribed 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 mine rals such as lime, other soil add itives, mechanical weed control, biological control of pests, and disease control primarily through management practices (Heatherly et al. 2009; Kuepper 2003; USDA-AMS 2011). Ba sed 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 an d Greene 2008). The standard ro w spacing may be utilized by organic farmers to facilitate mechanical weed control that would be hindered by narrow row spacing where weed control is acc omplished by chemical means that are prohibited in organic

18 Section 205.202(c)– 34 – systems. Further, organic soybean operations ro tated 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 pl ants to outcompete weeds, increa sing seeding rates, sowing cover crops, rotating crops, intercropping, flame weedi ng, hand weeding, and tilli ng (Heatherly et al. 2009; Kuepper 2003). Organic crop production historically empl oyed mulch and ridge tillage practices (NCAT 2003); no-till practi ces 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 fact ors contributing to poor weed control included uneven seeding beds produc ed by chisel-tilling in a cover crop and animal manure, variable ground cover occurring in mowed cover crop residue, insu fficient disruption of weed roots by sweep-type cultivators, and the short grain crop rotation syst em used was unsuitable for maintaining a low weed seedbank (Teasdale, Coffman, and Mangum 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 describe d 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, us ing management practices that promote healthy soil, rotating crops, diligently re moving 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 syntheti c 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 (USDA-ERS 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). Ta ble 2-8 indicates the acreage of organic soybean pro duced in each state.

Organic soybean field yields are lower or equa l 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 conven tional soybean yield (McBride and Greene 2008). Lower yields are generally attributed to competition with weeds in organic systems.

In 2006, the total estimated additional costs for producing organic relative to conventional soybeans were $0.82 per bushel for operating cost s 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).– 35 – Table 2-8 US Certified Soyb ean Acreage by State, 2011

State Acres State Acres Arkansas (D) Missouri 5,505 Delaware (D) Nebrask a 6,211 Georgi a (D) New Jersey (D) Idaho (D) New Yor k 8,621 Illinois 6,633 North Carolin a (D)
Indian a 945 North Dakot a 3,288
Iow a 12,659 Ohio 5,634 Kansas 1,311 Penns y lvani a 1,280 Kentucky (D) South Dakot a 3,962
Louisian a (D) Tennessee (D) Maine (D) Texas (D) Marylan d 1,090 Vermont 527 Michiga n 11,699 Virgini a 150
Minnesot a 16,150 Wisconsi n 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 tha n the US total of 96,080 acres.



### 2.2.3.4 Specialty Production Systems
Specialty production refers to speci alized agronomic practices as co mpared 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 s oybean. Distinct identity-preserved specialty soybean with such traits as clear hilum or high protein have been grown and successfully mark eted for specific food uses in domestic and export markets for many years (Cui et al. 2004). The specialty soybean market produces soybeans that ha ve 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 sm aller volumes than commodity soybean. Specialty soybeans can be grouped into several broad, but overlapping, categories, as listed below.

 Altered seed composition

o Low saturated fat

o High sucrose

o High oleic fatty acid

o Low linolenic fatty acid

o High protein– 36 –  Unique physical characteristics or uses

o Clear hilum

o Tofu

o Natto

o Soy milk

The categories are not exclusive. Soybeans of a ll specialty categories are often derived from varieties produced according to certified seed pro duction practices, as described in Section 2.2.3.1, Seed Production

.
Specialty soybeans often earn premiums (Pritc hett, Fulton, and Lawson 2002). The greatest premium received by producers is for tofu soybeans, but these ha ve higher production costs related to seed cost, technology fees, a nd transportation costs. Seed soybe ans have additional costs related to more intensive production/management requir ements and herbicide costs, although the seed technology fees and additional transporta tion costs remain important factors.

Product differentiation and market segmentation in the specialty soybean industry includes mechanisms to keep track of the grain (tr aceability) for IDP and quality assurance processes (e.g., ISO9001-2000 certification), as well as cont racts between growers and buyers that specify delivery agreements (Sundstrom et al. 2002). Syst ems used by specialty soybean growers and end users to maintain identity of the production include:

 Contracts – written agreements detai ling responsibilities and dutie s 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 fo r identifying and detect ing acceptability of materials.

 Quality Assurance Processes – oversight on handling procedur es, testing planting seeds, and testing harvested materials to determine acceptability of use and product requirements, and assuring testing proc edures are appropriate.

 Closed-Loop Systems – the end-user supplies the planting seeds and guarantees to purchase final products. This may also require that the en d-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 pur ity of the soybean pr oduct, this production 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 pr oduction require that all equipment and storage facilities for specialty soybean must be clean of seed from other so ybean 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– 37 – 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 mainta in 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 impact ed by soybean agriculture. Climatic conditions, in the context of potential climat e change, are also discussed.



### 2.3.1 Soil

Soil consists of solids (minerals and organic matte r), liquids, and gases. Th is body of inorganic and organic matter is home to a wide variety of fung i, 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 attenuati on capacity. Soil properties change over time: temperature, pH, soluble salts, amount of orga nic 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 organi c matter levels directly influence its shear strength, nutrient holding capacity, and permeability.

Soil taxonomy was established by sc ientists to classify soils accord ing to the relationship between soils and the factors responsible for their char acter (USDA-NRCS 1999b). Soils are differentiated based on characteristics such as particle size, textur e, 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 maintain ing 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 im portant in nutrient cycling, cation exchange capacity 19 , and the breakdown of pest icides (USDA-NRCS 1996).

The interactions be tween 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, su bsequent nutrient cy cling and release, and maintaining soil structure and composition. Cultivation directly impa cts these biological attributes. Agronomic practices such as conventional tillage and mechan ized harvesting machinery may disturb and expose the top soil surface layer, leaving the land prone to degradation or, conversel y, improving soil health.

19 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 ad sorb and store soil cation nutrients (positively charged ions such as potassium, calcium, and ammonium).– 38 – Soil degradation can lead to a de cline in water quality and contribu te to the greenhouse effect by releasing sequestere d carbon dioxide (CO 2 ) (Lal and Bruce 1999). A decl ine in soil quality and soil resilience enhances the greenhouse effect through emissions of radiatively active gases (CO 2 and nitrous oxide, N 2 O). Land that is prone to degradation is al so 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 agricult ural practices can lead to increased erosio n, soil compaction, degradatio n of soil structur e, nutrient loss, increased salinity, change in pH, and redu ced biological activity (USDA-NRCS 2001).

Soybeans are grown in managed ag ricultural 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 vari ety 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, mang anese, molybdenum, cobalt, and chlorine. These micronutrients may be deficien t in poor, weathered soils, sandy soils, alkaline soils, or soils excessively high in organic matter. As with proper nutrient le vels, soil pH is critical for soybean development. Soybeans gr ow best in soil that is sligh tly acidic (pH 5.8 to 7.0); more alkaline soils (pH 7.3 or greater) negatively affect yi eld (Cox et al. 2003). Si milarly, soils that are high in clay and low in humus may impede plant emergence and development (NSRL undated). Soils with some clay content ma y 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 cove r to the soil between seasons and improve soil fertility by maintaining nutrient-ri ch 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 leachi ng over time (USDA-NRCS 2006a, 2006b). Organic matter builds up in the soil, absorbing CO 2 and helping to reduce a significant amount of greenhouse gas.

One of the most effective soil co nservation methods to reduce wind and water erosion is through management of crop residue, whic h also benefits air and water qu ality and wildlife (USDA-NRCS 2006a). Residue management that us es intensive tillage an d leaves low amounts of crop residue on the surface result s in greater lo sses of soil organic matter as compared to cons ervation 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 incr ease organic matter an d improve infiltratio n, soil stability and structure, and soil microorg anism habitat (USDA- NRCS 2005; Fawcett and Caruana 2001).

The residue left over fro m conservation tillage practices incr eases organic matter in the top 3 inches of the soil and protect s the surface from erosion while maintaining water-conducting pores. Soil aggregates in conservation tillage system s are more stable than those of conventional tillage due to the products of or ganic 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– 39 – 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 us e of herbicides and the corresponding reduction in the need for mechanical weed control (Carpenter et al. 2002). Another factor is the Conservation Reserve Program descri bed in Section 2.2.2.1, wh ich provides financial incentives to farmers to use cons ervation tillage techniques or set aside land from agricultural use (USDA-FSA 1999). Conservation tillage also minimizes soil co mpaction due to the reduced number of tillage trips.

While conservation tillage does have several benef its for soil health, some management concerns are associated with its use in certain circumst ances. 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 suite d for no-till. No-till practices may lead to increased pest occurrences that conv entional 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 improv e 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 br eaks, crop rotations, and varying tillage practices (USDA-NRCS 2006a).

There are a multitude of organisms associated w ith 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 nema todes, as discussed in Section 2.4.3, Soil Microorganisms . These organisms are responsible for a wi de range of activities that impact soil health and plant growth. Pesticide (including herbic ide) use has the potential to affect soil quality due to potential impacts to the so il 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, isoxaf lutole, and glufosinate (t he three herbicides of which SYHT0H2 soybean is tolerant) is discussed in detail in the appendices.



### 2.3.2 Water Quality

The primary cause of agricultural nonpoint source (NPS) pollution is increased sedimentation from soil erosion, which can introduce se diments, 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– 40 – EPA requirements such as appl ication methodology and buffer zo nes between fields and water bodies, as well as monito ring for herbicide residues in surface and ground water. Ther e are no federal water quality standards for the enzymes present in transgenic herbicide-tolerant plant varieties.

Although meteorological (precipitation, temperatur e), morphological (land use, soil type), and environmental fate drivers affect water qualit y, anthropogenic practices (product use and management) are the most relevant, as these are generally under direct grower control on a soybean farm (Ramanarayanan, Narasimhan, and Srinivasan 2005). Certain agronomic practices, including conservation tillage and reduced fertilizer or pes ticide application rates, may reduce adverse impacts. The EPA recommends se veral Best Management Practices for protecting water quality from agricultural NPS pollution (USEPA 2008a):

 Conservation Tillage - leaving crop residue (p lant materials from past harvests) on the soil surface reduces runoff and soil erosion, conserve s soil moisture, helps keep nutrients and insecticides on the field, and impr oves 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 insect s, weeds, disease, and other pests below economically harmful levels while prot ecting soil, water, and air quality; and

 Conservation Buffers - from simple grassed waterways to riparian areas, buffers provide an additional barrier of protecti on by capturing potential pollutant s 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, a llowing more time for absorption into the soil, and slowing down soil mo isture evaporation (Locke, Zablotowicz, and Reddy 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 (Loc ke, Zablotowicz, and Reddy 2008).



### 2.3.3 Air Quality

Agriculture is an important market sector imp acting air quality. Agricultural air emission sources include: smoke from agricultural burning, vehicl e exhaust from equipment used in tillage and harvest, soil particulates (dust) from tillage, pesticide drift from spraying, and N 2 O emissions from the use of nitrogen fertilizer (Aneja, Schlesinge r, and Erisman 2009). Ce rtain pesticides may volatilize after application to soil or plant surface s and may also move as constituents of dust in– 41 – wind eroded soils (Vogel, Majewski, and Capel 2008) . Agricultural air polluti on also contributes to odor. After deposition of reactive nitr ogen in waterways, eutrophication and acidification can result and affect biodiversity. Air quality can be improv ed 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 20 12d), the second-highes t source. Agricultural soil management practices, including nitrog en-based fertilizer application and crop ping practices, are the largest source of N 2 O emissions in the US, accounting for 67.9 percent of the total N 2 O emissions attributable to agricultural land uses (U SEPA 2012d). Agriculture sources of methane (CH 4 ) emissions are primarily associated with enteri c emissions of gas from cattle and manure management, and are responsible for 29 percent of CH 4 emissions from anthropogenic activities in the US (USEPA 2012d). CO 2 is also a significant GHG associated with pa rticular classes of cr ops planted, geographic location and so il types, and energy consum ption (Cole et al. 1997).

GHGs may be affected by the cla ss 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 N 2 O, produced naturally in soils through micr obial 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 se questered in soil, resulting in CO 2 loss to the atmosphere.

In agricultural soils, mineral and organic soils sequ ester approximately six times as much carbon as is emitted from these soils through liming and urea fertilization (USEPA 2012d). The mineral soil carbon sequestration is largely due to the convers ion of cropland to permanent pastures and hay production, a reduction in summer fallo w 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 agricult ural practices on diffe rent soil types (USEPA 2012d). 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 pe rcent of the natural organic carbon to decompose and be released to the atmosphere. In contrast to mineral soils, organic soil s may contain as much as 20 percent carbon by weight. When such soils are prepared fo r agricultural use, they are aerated, accelerating decomposi tion and release of CO 2 to the atmosphere.

Tillage contributes to the release of GHGs from soil because of the loss of CO 2 to the atmosphere from the exposure and oxidation of soil organi c matter (Baker, Southard, and Mitchell 2005). Reduced tillage can li mit the loss of CO 2 to the atmosphere by preventing exposure and oxidation of soil organic matter (Baker, Southard, and Mitche ll 2005; CAST 2009). In general, conservation tillage strategies are associated with more stab le and increased carbon sequestration due to a net reduction in CO 2 emissions (Lal and Bruce 1999; West and Marland 2002). Recent literature, however, suggests that the relationship between conservation tillage and increased carbon– 42 – sequestration requires more study, as soil depth le vel and seasonal sampling bias may inadvertently affect measurements (Baker et al . 2007; Potter et al. 1998). Increased N 2 O emissions as a result of conservation tillage strategies may offset any gains achieved through increased carbon sequestration (Gregorich et al. 20 05). A broad generalization re garding the impact of tillage strategy and N 2 O emissions is diffic ult to make, as numerous factor s influence soil nitrification cycles, including geographic location, soil struct ure, moisture, and farm-level management practices (Grandy et al. 2 006; Gregorich et al. 2006; Rochette et al. 2008).

The impacts of genetically engineered crop va rieties 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 af fects agriculture through shifts in precipitation patterns and temperature ranges. The production of ge netically engineered soybeans is expected to result in lower GHG emissions becau se fuel use would be reduced due to less frequent herbicide applications and soil cultivation (Brookes and Barfoo t 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 dr ought). In addition, the current range of weeds and pests of agriculture is expe cted to change in response to climate change (USGCRP 2009).



### 2.4 Biological Resources

The biological resources described in this secti on include animals, plants, soil microorganisms, biodiversity, and soybean gene movement. Threaten ed 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, rodent s, other mammals, and birds such as upland gamebirds. Fields also provide a forage base fo r insects (Palmer, Bromley, and Anderson undated). During the winter months, leftover and unharveste d soybeans provide a food source for wildlife; however, soybeans are poorly suited for meeting nutrient needs of wild life, such as waterfowl, that require a high-energy diet (K rapu, Brandt, and Cox 2004).

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 be en more inclined to plant genetically engineered herbicide-tolerant soybean varieties than farmers retaining conventional practices (Givens et al. 2009). The in creased use of conservation tillage practices has benefitted wildlife through improved water quality, availability of wast e 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 in crease the diversity and density of birds and mammals (USDA-NRCS 1999a). Increased residue also provides habitat for insects and other– 43 – arthropods, increasing this food source for insect pr edators. Insects are important during the spring and summer brood rearing season for many upland game birds and ot her birds, as they provide a protein-rich diet to fast growin g young, as well as a nutrient-rich diet for migratory birds (USDANRCS 2003).

Insects and other invertebrates can be benefici al 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 (Ahrent and Caviness 1994; Er ickson 1975). Soybean cultivars vary in their rate of nectar secretion and some varieties have been reported to be attractive to honeybees (Ahrent and Caviness 1994). Converse ly, there are many insects and invertebrates that are detrimental to soybean crops (Palme r, Bromley, and Anderson undated; Whitworth, Michaud, and Davis 2012), 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 soybea n production; however, insect injury can impact yield, plant maturity, and seed quality. Consequently, insect pests ar e sometimes managed during the growth and development of soybean to enhance soybean yield (Are f and Pike 1998).



### 2.4.2 Plant Communities

Soybean fields are typically bordered by other agricultural fields, pastures, woodlands, or grasslands; natural plant communitie s adjacent to fields may be impo rtant to biodiversity. From an agronomic perspective, the most important me mbers of a surrounding plant community are those that can behave as weeds when they have i nvaded 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 pe rennials. An annual is a plant that completes its lifecycle in 1 year or less and repr oduces only by seed. Biennials are plants that complete their life– 44 – cycles in 2 years. Perennials are plants that live fo r 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. Ma ny plant species occur as weeds in fields.

Plant communities adjacent to agricultural fields ma y be affected by spray dr ift 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 stru cture formation, decomposition of organic matter, toxin removal, nutrient cycling, and most bioche mical soil processes (Garbeva, van Veen, and van Elsas 2004). The main factors affecting microbia l population size and diversity include soil type (texture, structure, organic matter, aggregate st ability, 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, van Veen, and van Elsas 2004), as described in Section 2.3.1, Soil . Plant roots, including those of soybeans, release a variety of compounds in to the soil creating a unique environment for microorganisms in the rhizosphere. Microbial dive rsity in the rhizospher e may be extensive and different from the microbial co mmunity in bulk soil (Garbeva, van Veen, and van Elsas 2004).

Decomposers (such as bacteria, actinomycetes [f ilamentous bacteria], and saprophytic fungi) degrade plant and animal remains, organic materi als, and some pesticides (USDA-NRCS 2004). Other organisms (such as protoz oa, mites, and nematodes) consum e the decomposer microbes and release macro- and micronutrients, making them ava ilable for plant usage. Mutualists (mycorrhizal fungi, nitrogen-fixing bacteria, and some free-living microbes) ha ve co-evolved with plants and supply nutrients to and obtain food fr om 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, incl uding 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 ammo nia 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 (Pedersen 2007; Berglund and Helms 2003).



### 2.4.4 Biodiversity

Biodiversity refers to all plants, animals, and microorganisms interacting in an ecosystem, and provides valuable genetic resources for crop im provement (Harlan 1975). With reference to agriculture, biodiversity supports pollination, biol ogical control, and nutrient recycling. These processes support competition against pests by natura l enemies, improve soil structure, facilitate– 45 – soil and water conservation, suppress disease, contro l the local microclimate and local hydrological processes, and detoxify noxious chemicals (Altieri 1999).

Relative to any natural ecosystem, species ab undance and richness will generally be less in intensively managed agroecosystems. 20 However, biomass may be higher as a result of introduced fertilizers and additional water that would not be present naturally. Th e degree of biodiversity in an agroecosystem depends on four primary characteristics (Altieri 1999; Palmer, Bromley, and Anderson 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 agro ecosystem from natural vegetation.
Tillage, seed bed preparation, monoculture crop planti ng, pesticide use, fertilizer use, and harvest may all limit the diversity of plants and animals in an agri cultural field (Lovett, Price, and Lovett 2003). Herbicide use in agricultural fields may impact bi odiversity by decreasing weedspecies and other nonweedy plants present in the field and the insect s, 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 introgre ssion, biological control, and nutrient recycling (Altieri 1999). Woodlots, fencerows, hedgerows, wetlands, and the like have been used to introduce biodiversity into large scale monocu ltures. Other enhancement strategies in agroecosystems include intercropping (planting of tw o or more crops simultaneously to occupy the same field), agroforestry, crop rotations, cove r crops, no-tillage, comp osting, green manuring (growing a crop specifically for the purpose of inco rporating it into the soil in order to provide nutrients and organic matter), addition of organi c matter (compost, green manure, animal manure, etc.), and windbreaks (Altieri 1999).

Agriculture interacts with biodiversity at the cr op, farm, and/or landscape level (Carpenter 2011). In this ER, crop diversity refers to the absence of genetic uniformity wi thin crops, farm level diversity refers to the level of complexity of organisms within the bou ndaries of a farm, and landscape level diversity refers to land use pa tterns beyond the farm bou ndaries (Carpenter 2011). Each of these levels is desc ribed in further detail below.



### 2.4.4.1 Crop Diversity
Genetic diversity in crops is beneficial as it may improve yiel ds, pest and diseas e resistance, and quality in agricultural systems. Greater varietal and intra-species divers ity enables growers to maintain productivity over a wi de range of condition s (Krishna, Zilberman, and Qaim 2009). The adoption of genetic engineering technology might re duce grower demand for crop genetic diversity because breeding programs could co ncentrate on a smaller number of high value cultivars, which could reduce the availability of, and demand for, non-genetically engineered varieties (Carpenter 2011; Krishna, Zilberman, and Qa im 2009). However, several st udies involvin g genetically engineered soybeans and cott on have found this not to be the case, indicating th at the introduction of

20 An agroecosystem is the organisms and environment of an agricultural area when considered as an ecosystem.– 46 – genetically engineered cultivars has not decreased crop species dive rsity (Carpenter 2011; Krishna, Zilberman, and Qaim 2009).

Concern about the loss of genetic variability for cr ops 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, a nd evaluates soybean germplasm and distributes seed samples to scientists in 35 states (Pereg rine 2003). Nationwide, th ere 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 bi odiversity 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 allowi ng 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 increas es soil organic matter, which benefit soil biota by providing additional food sources (energy) (U SDA-NRCS 1996) and increasing the diversity of soil microorganisms, as di scussed in Section 2.4.3, Soil Microorganism s. In addition, invertebrates that feed on plant detritus and the other animals (i nvertebrates, birds, reptiles, and mammals) that prey on them may benefit from conser vation tillage practices (Carpenter 2011).

Herbicide use in agricultural fi elds 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 ma mmals that utilize these species. Th e quantity and type of herbicide use associated with crops is dependent on many variables, including cropping systems (including non-genetically engineered and genetically engineer ed 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 na tural ecosystems into agri cultural 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). Ho wever, substantial gains in yields have generally not been obtained by herbicide-tolerant cultivars unless the he rbicide tolerance trait has been introduced into higher yielding cultiv ars (NRC 2010).

The use of herbicides also has th e potential to impact biodiversity at the landscape level. Increased conservation tillage practices associated with he rbicide-tolerant crops at the farm scale but implemented over large areas may regionally incr ease certain populations of invertebrates and wildlife that benefit from c onservation tillage, whereas the speci es dependent on the targeted weeds may be negatively impacted. For example, it has been suggested that reductions in monarch– 47 – 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 overwinteri ng 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 lands cape-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 requirem ents 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 thro ugh 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/Rura l Environmental Stewardship 21 and the Center for Integrated Pest Management. 22 These programs promote environmental stewardship and provide information and guidance on biodiversity i ssues such as conservation buffers, wildlife habitat, wildlife stewardship, and pollinator health and protection.



### 2.4.5 Gene Movement in th e Natural Environment

Gene flow is the movement of genes from one population to another, conf erring new traits – the biophysical characteristics of the s ource organism – to individuals of the recipient population (Quist 2010). This happens by cross-pollina tion (also called hybridization): the pollination of members of one population or genetic pool with pollen from another. Vertical gene tran sfer is genetic in formation that is passed ‘down’ from parents to offspring or related sp ecies. Horizontal gene tran sfer is the passage of genes from one organism to an unrelated one by means other than inheritance. Ve rtical 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 ev idence that horizontal gene transfer can naturally occur between unrelated plant sp ecies (Stewart, Halfhill, and Warwick 2003).

Characteristics that favor natura l hybridization between two popula tions of related species include (Mallory-Smith and Zapiola 2008):

 Presence of feral populations and uncontrolled volunteers;

 Presence of a high number of hi ghly compatible relatives;

 Self-incompatibility;

 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.

21 http://curesworks.org 22 http://pesticidestewardship.org– 48 – 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 2000), and does not require insects to pollinate flowers. Flowers are typically clei stogamous but, in some cultivars and under some conditions, may be chas mogamous and insects may transfer pollen (Chiari et al. 2005; Ahrent and Caviness 1994; Ray et al. 2003; Erickson 1975). Insect-mediated cross-pollination to adjacent plants may occur through pollinating insects such as honeybees. Incidental pollen transfer by nonpollinating insect s occurs at very low frequency (typically less than 1 percent with narrow row spacing) (Caviness 1966; Ray et al. 2003; Yoshimura, Matsuo, and Yasuda 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 e nvironmental conditions grows as a volunteer in the year following cultivation (OEC D 2000). Volunteer soyb ean seed is typically not viable after the winter period in the northern US. In the southe rn US soybean seed may remain viable over the winter and germinate the following spring (Car penter et al. 2002; OECD 2000). 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 cultiv ation 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 s oybean feed products, and the indirect effect on human health and worker safety from labor ers’ exposure to agricultural chemicals.



### 2.5.1 Human Health

Soybean oil makes up 94 percen t of the soybean f ood ingredients consumed by humans (OECD 2001). The essential amino acids re quired by humans are present in soybean proteins. Soy protein products are added to a number of meat, dairy, bakery, and cereal pr oducts as protei n extenders. Soy sprouts, baked soybeans, roasted s oybeans, soy flour, and traditional soy food s (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 proce ssing (OECD 2001):

 Protease inhibitors are active against trypsin and chymotrypsin, an d interfere with the digestion of proteins resulting in decreased anim al growth. The activity of these inhibitors is destroyed when the bean or meal is toasted or heated during processing.

 Lectins are proteins that bi nd to carbohydrate-containing molecu les. Lectins in raw soybeans can inhibit growth and cause death in animals and, potentially, in humans. Lectins are rapidly degraded upon heating.– 49 –  Soybeans naturally contain a number of isoflavone compounds reported to possess biochemical activity, including es trogenic, anti-estrogenic, a nd hypocholesterolemic effects, in mammalian species. Processing significantly re duces isoflavone isomers in the final soy products.

 The low molecular weight carbohyd rates stachyose and raffinose ar e considered antinutrients due to the gas productio n and resulting flatulence caused by th eir consumption. Furt her processing of soybean meal into concentrate or isolate reduces or removes these oligosaccharides.

 Phytic acid chelates mineral nutrients (i ncluding 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. Th e presence of these allergenic proteins in the diet of hypersensitive individuals can caus e severe adverse reactions in the gastrointestinal tract.

Nontransgenic soybean varieties, both those devel oped 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 re lease in the market. Under the FFDCA, it is the responsibility of food and feed manuf acturers to ensure that the pro ducts they market are safe and properly labeled. Food and feed derived from genetically engineered soybean must be in compliance with all applicable le gal and regulatory requirements.

Genetically engineered organisms for food and feed may unde rgo a voluntary co nsultation process with the FDA prior to release onto the mark et (USDHHS-USFDA 1992). Al though voluntary, thus far all applicants who have wished to commerciali ze a genetically engineered variety of a plant that would be included in th e food supply have comp leted a consultation with the FDA. In such a consultation, a develope r who intends to commer cialize a bioengineered food consults with the agency to identify and discuss rele vant safety, nutritional , or other regulatory issues rega rding the bioengineered food and then submits to FDA a summary of its sc ientific and regu latory assessment of the food (USDHHS-USFDA 1997). This process includes the de veloper’s subm ission 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 pr operties of the food or feed.

 The identity and function of expression products encoded by the introduced genetic material, including an estimate of the c oncentration of any expression product in the bioengineered crop or food derived thereof.

 Any known or suspected allergen icity or toxicity of expres sion products and the basis for concluding that foods contai ning 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 va riety or other commonly consum ed varieties with special emphasis on important nutrients and toxican ts 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.– 50 –  Any other information relevant to the safety and nutritional assessment of the bioengineered food.
FDA evaluates the submission and responds to th e developer by letter with any concerns it may have or additional information it may require. Seve ral international agencies also review safety associated with food and feed items derived from genetically engineered crops; these agencies include the European Food Safety Agency (EFS A) and the Australia and New Zealand Food Standards Agency (ANZFS).

Foods derived through bi otechnology also under go a comprehensive safe ty evaluation before entering the world market, includ ing reviews under standards set by the CODEX, the EFSA, and the World Health Organization (F AO and WHO 2009; Hammond and Jez 2011). Food safety reviews compare the compositional characte ristics of the genetically engine ered 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 conditi ons, including va rious agronomic inputs. Composition characteristics evaluated in these comparative tests include moisture, protein, fat, carbohydrates , ash, minerals, dietary fiber, essential and non-essentia l amino acids, fatty acids, vitamins, and antinutrients.

There are multiple ways in wh ich organisms can be geneti cally modified through human intervention. Traditional methods in clude breeding or cros sing an organism to e licit the expression of a desired trait, while more contem porary approaches include the use of bi otechnology such as genetic engineering to produce new organisms (NRC 2004). Unexpected and unin tended compositional changes arise with all forms of genetic modificat ion, including both conven tional hybridizing and genetic engineering (NRC 2004). Th e NRC also noted that (at the time of thei r study in 2004), no adverse health effects attributed to genetic engineering had been do cumented in the human population. Reviews on the nutritio nal quality of genetically engi neered foods have generally concluded that there are no significant nutritional differences in conventional versus genetically engineered plants for f ood or animal feed (Fau st 2002; Flachowsky, Ch esson, and Aulrich 2005).



### 2.5.2 Worker Safety

Workers engaged in soybean production may encount er 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 Prot ection Standard (WPS) that protects field workers from the hazar ds of chemical exposure (USEPA 1992). The Occupational Safety and Health Administration requires all employe rs to protect their employees from hazards associat ed with chemicals.

Most soybean acreage in the US is treated with pesticides; herbicides are the most commonly applied pesticides, but some acres are treated w ith insecticides and/or fungicides. Changes in acreage, crops, or farming practices can affect th e 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.– 51 – 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 hand lers. The WPS offers protection to more than 2.5 mil lion agricultural workers who work with pesticides at more than 600,000 wo rkplaces on farms, fo rests, nurseries, and greenhouses (USEPA 2012f). The WPS contains requirements fo r pesticide safety training, notification of pestic ide applications, use of personal protecti ve equipment, restri cted 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 pr oduced in the US (GINA 2011; Soyatech 2012). Poultry consume mo re than 48 percen t of domestic soybean meal (13 million tons), with soy oil increasingly replacing animal fats and oils in broiler diets (Soy stats 2010). Other animals fed domestic soybean (by crop volumes consumed ) include swine (26 pe rcent), beef cattle (12 percent), dairy cattle (9 percent), other (e.g., farm-raised fish; 3 percen t), and household pets (2 percent) (Soystats 2010). Soyb ean can be the dominant component of livestoc k diets: for example, upwards of 66 percent of poultry protein intake is derived fr om soy (Waldroup a nd Smith undated).

Because of the presence of anti-nut ritional factors in raw soybean, th ere is very limit ed consumption of the unprocessed bean. Most livestock is fed the pr otein-enriched seed meal left after extraction of soybean oil. Treated whole beans, hulls and the vege tative parts of the plant in a fresh or conserved state are also used to a limited extent, primarily fo r cattle. Soybean has a long history in the US as a nutritious grazing forage, hay, and silage crop for livestock (Bloun t et al. 2009). Soybean may be harvested for hay or grazed from the flowering stag e 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, su ch 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 th e products they market are safe and properly labeled. Feed derived from genetica lly 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 proce ss with FDA may be implemented before release of genetically engineered plants in animal feed into the mark et, following the process described above. Thus far all applicants who wish to commerc ialize a genetically engineered variety that will be included in the feed supply have completed a consulta tion with the FDA.



### 2.6 Socioeconomic Factors

Soybean agriculture can affect socioeconomic res ources such as the domes tic trade environment, foreign trade environment, and the socioeconomic environment. This section describes key current issues within each of these topics.– 52 – 

### 2.6.1 Domestic Trade Environment

In 2010, 76 million acres of soybeans were cultiva ted in the US, yielding 3.3 billion bushels at a value of $38.9 billion (USDA-NASS 2011a). The top ten produc ing states (Iowa, Illinois, Minnesota, Indiana, Nebraska, Ohio, Missouri, South Dakota, Kansas , and North Dakota) accounted for more than 80 percent of this pro duction. 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) come s from domestic production and almost all of this supply (96.8 percent) is either exported or crus hed for meal and oil (USDA-ERS 2011c, 2011a; O’Donoghue et al. 2011). Approximately 43 percen t of US soybean is destined for the export market (USDA-ERS 2010b) and the remaining 57 percent of US soyb ean is primarily utilized to produce soybean meal for feed, with lesser amount s processed for soybean oil for industrial or consumption purposes; seed and residuals; or endi ng stock for storage. On ly a small proportion of the soybean crop is consumed dir ectly by humans (GINA 2011).

Managing production costs is a major component of the economics of pro ducing a soybean crop. Key cost decisions include the choice of which s oybean 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 cost s 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 am endments ($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, in creased 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 va ry in terms of land productivity and cost of production. The most produ ctive of these regions are the Heartl and and Northern Cr escent; the least productive are the Eastern Uplands, Southern Seaboard, and Mississippi Portal (Fernandez-Cornejo and McBride 2000). While the Heartl and and Northern Crescent regi ons have high production costs, their higher productivity results in greater profitab ility. In 2010, th e US total gross average value of soybean production per planted acrewas $449.32 and the average pric e of a bushel of soybeans at harvest was $9.56 (U SDA-ERS 2011b). Economic returns since 194 8 (when record-k eeping began) have increased from $48 per ac re to $486 per acre in 201 1, 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 valu e of all field crop s (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 production is expected to increase from $39.4 billion to $40.5 billion, due in pa rt to the higher forecast price described below.– 53 – 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 an d $8 per bushel from 1986 until 2006, but in subsequent years were in the range of $12 per bu shel (Soystats 2011a). As of early March 2013, soybeans prices were at $14.73 pe r bushel (RCG 2013) and the pric e range forecast by USDA-ERS for the 2012/2013 season was $13.55 to $1 5.05 per bushel (USDA-ERS 2013b).

There is a niche market for nontransgenic food and f eed in the US, as is evid ent from private labeling initiatives such as the Non-GMO Project. 23 This initiative offers third-party product verification and labeling for nontr ansgenic products. There also is a nich e 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 percen t increase between 2009 an d 2010 alone (OTA 2011). To satisfy the demand for organic soybean, producers have adopted specif ic 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 ofte n paid for nontransgenic or organic soybean. For example, the price for non-organic so ybean (the majority of which is used for li vestock feed) in early March 2013 was nearly $14.75 per bushel, as me ntioned above, wherea s organic soybean for livestock feed ranged be tween $25.00 and $ 27.25 per bushel (USDA-AMS 2013).

There is consistent evidence that farmers obtain s ubstantial financial and non-financial benefits as a result of adoption of genetically engineered crops as opposed to nontransgenic (but not “organic”) crops (Duke and Powles 2009; Fernandez-Cornej o and McBride 2000; Fernandez-Cornejo, KlotzIngram, and Jans 2002). These benefits include:

 An opportunity to increase income from off-farm labor;

 Increased flexibility and simplicity in the application of pesticides;

23 http://www.nongmoproject.org/

.– 54 –  An ability to adopt more environm entally friendly farming practices;

 Increased consistenc y 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 bu lk soybean, meal, and oi l 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 fo r 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.– 55 – Table 2-10 World Soybea n 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-27 2 -- -- 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 ma rkets 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 soybe an 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 Market s 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 64,0 59 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 29,8 16 13,510 33,819 Saudi Arabia 72,575 0 0 0 Thailand 34,105 603 6,240 0 Turkey 27,705 38,2 35 3,847 18,000

Source: (USDA-FAS 2013)– 56 – US soybean and soy product exports exceeded $21.5 billion in 2011. China was the largest customer for US soybeans with purchases exceed ing $10.4 billion. Mexico was the second largest market for US soybeans with purc hases of nearly $1.6 billion. Othe r significant buyers included Japan with purchases of $954 million and Indonesia with purch ases of $859 million. Soybeans produced in China and India are primarily for dom estic use, but China’s imports of soybean are expected to account for more th an 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 de tailed data are available) is shown in Table 2-12.

Table 2-12 US Export Markets for Soybean and Soybea n 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 Re public 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 syst em such as the US.

The rotation of crop s between soybean a nd corn drives much of the economic environment for US farmers. Soybean acreage pl anted in the last 3 year s has hovered around 76 to 77 million acres, as described in Section 2.2.1, Current and Projected Acreage and Range of Soyb ean Production

. Higher per-bushel prices, as describe d in Section 2.6.1, Domestic Trade Environment , may result in the forecasted rebound in soybean planti ngs for 2013.– 57 – 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-resist ant 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 gr owers. One economic analysis places this cost in the range of $12 to $18 pe r acre (Mueller et al. 2005).

Genetically engineered traits such as herbic ide 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 gl yphosate-tolerant soybeans in the US in 1996 revolutionized the way that growers managed w eeds in their soybean fields. Growers rapidly adopted the technology because of its effectivene ss 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).– 58 – This page intentionally left blank.– 59 – 

## 3 ALTERNATIVES

This Chapter describes the alternatives consider ed regarding deregulati on of SYHT0H2 soybean. To approve the petition for nonregulated st atus, APHIS must fi rst determine that SYHT0H2 soybean is unlikely to pose a plant pest ri sk. If the Plant Pest Risk Assessment (PPRA) determines that SYHT0H2 soybean is unlikely to pose a plant pest risk, APHIS must conclude that SYHT0H2 soybean is no longer subject to 7 CFR part 340 or the plant pest provisions of the PPA.



### 3.1 No Action: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition and the status quo would be maintained. SYHT0H2 soybean and progeny derive d from SYHT0H2 soybean would continue to be regulated articles. SYHT0H2 soybean would be grown under USDA notification or permit and confined release conditions. It woul d have restricted availability to growers. Measures to ensure physical and reproductive confinement would continue to be implemented. Growers would continue to use other deregulated transgenic soybean varieties, currently comprising some 93 percent of the US soybean market, or nont ransgenic soybean cultivars (including organic soybeans) that are available without restrictions. APHIS could choose this alternative if there were insufficient evidence to demonstrat e the lack of plant pest risk fr om the unconfined cultivation of SYHT0H2 soybean.

As documented in Chapter 4, SYHT0H2 soybean is unlikely to pose a plant pest risk. Choosing this alternative would not satisfy the purpose and n eed of making a determination of plant pest risk status and responding to the petition for nonregulat ed status. Additionally, this alternative would not satisfy the product purpose of and need for the product: providing growers with an additional product to control weeds, including herbicide resist ant weeds. This product is expected to help prevent or delay the development of herbicide resi stant weeds and extend the useful life of other commercially available soybean herbicides, provide more flexibility in herbicide applications and economic benefits for growers, a nd increase competition in the mark etplace for herbicide tolerant seed products.



### 3.2 Preferred Alternative: Determinat ion that SYHT0H2 Soybean is No Longer a Regulated Article

Under the Preferred Alternative, SYHT0H2 soybean and its proge ny would no longer be regulated articles under the regulations at 7 CFR part 340. As documented in Chap ter 4, SYHT0H2 soybean is unlikely to pose a plant pest risk. Permits issued or notific ations acknowledged by APHIS would no longer be required for introducti ons of SYHT0H2 soybean and progeny derived from this event. This alternative best meets the purpose and need to respond appropriately to a petition seeking 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 SY HT0H2 soybean is unlikely to pose a plant pest risk, a determination of nonregulated status of SY HT0H2 soybean is a response that is consistent– 60 – with the plant pest provisions of the PPA, th e regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework.

Under this alternative, growers may have future access to SYHT0H2 soybe an and progeny derived from this event if the developer decides to commercialize SYHT0H2 soybean. SYHT0H2 soybean may be sold as a stand-alone product, or potentially “stacked” with other transgenes by conventional plant breeding to deliver other genetically engineered traits, such as:

 Tolerance of other herbic idal modes of action;

 Resistance to insects; or

 Improvement of perfor mance characteristics.

As described in the Petition (Syngenta 2012c) , SYHT0H2 soybean exhibits tolerance to mesotrione and isoxaflutole herbicides, inhibi tors of HPPD, and to glufosinate-ammonium herbicide, an inhibitor of glutamine syntheta se. The herbicide-tolera nce traits in SYHT0H2 soybean will provide growers with more tools and greater flexibility and diversity in weed management options, and contribute to more su stainable weed management when used in combination with other herbicides and weed ma nagement tactics. In order to promote the responsible use of SYHT0H2 soybean and advan ce weed management to minimize the potential for weeds to develop resistance to these herbicid es, the Petitioners have developed a stewardship program that is detailed in Appendix F of the Petition.



### 3.3 Comparison of Alternatives

Table 3-1 summarizes the potential environmental cons equences associated with selection of either the No Action Alternative or the Preferred Altern ative. An objective evaluation of the No Action Alternative’s and Preferred Alternative’s pot ential impacts is provi ded in Chapter 4, Environmental Consequences

.– 61 – Table 3-1: Summary of Environmental Consequences and Regulatory Compliance

Attribute/Measure Alternative

No Action Preferred
Meets Purpose and Need, and Objectives N o Yes Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied through plant pest risk
assessment

So y bean Production Acreage and areas of soybean p roduction Unchange d Unchange d Croppin g practices Unchan g e d Unchan g e d
Pesticide use Unchan g e d Unchan g e d Organic soybean production Unchange d Unchange d Specialt y so y bean p roduction Unchan g e d Unchan g e d

P h y sical Environment Water qualit y Unchan g e d Unchan g e d
Soil Unchan g e d Unchan g e d Air quality Unchange d Unchange d
Climate Unchan g e d Unchan g e d

B iolo g ical Environment
Animals Unchan g e d Unchan g e d
Plants Unchan g e d Unchan g e d Soil Microorganisms Unchange d Unchange d
Biodiversit y Unchan g e d Unchan g e d
Gene movemen t Unchan g e d Unchan g e d

P ublic Health
Human health Unchan g e d Unchan g e d Animal (livestock) health Unchange d Unchange d
Worker safet y Unchan g e d Unchan g e d

Social and Economic Factors
Domestic trade environmen t Unchan g e d Unchan g e d
Forei g n trade environmen t Unchan g e d Unchan g e d
Social and eco nomic environmen t Unchange d Unchange d

Cumulative Effects Agronomic practices Unchange d Unchange d
Ph y sical environmen t Unchan g e d Unchan g e d
Biolo g ical environmen t Unchan g e d Unchan g e d Social and economic factors Unchange d Unchange d
Threatened and Endangered Species Unchan g e d Unchan g e d

Other Re g ulator y Approvals
US FDA consultation FDA consultation
Compliance with Other Laws CWA, CAA, ESA, EOs Full y complian t Full y complian t– 62 – This page intentionally left blank.– 63 – 

## 4 ENVIRONMENTAL CONSEQUENCES

This Chapter describes the potential environmenta l consequences of the two alternatives under consideration: the No Action Alte rnative and the Preferred Alternative. As described in Chapter 3, under the No Action Alternative SY HT0H2 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. 24 Limited field tests would be allo wed, but the product would not be marketed. Under the Preferred Alternative, AP HIS would determine that SYHT0H2 soybean does not pose a plant pest risk. SYHT0H2 soybean wo uld 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.

This Chapter provides an evaluation of the direct a nd indirect effects of th e 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 Introduction

This Section 4.1 describes the scope and methodology of the analysis, and assumptions adopted in Chapter 4. Sections 4.2 through 4.6 describe th e potential direct and indirect impacts to environmental and human resources from the No Action Alternative and the Preferred Alternative for SYHT0H2 soybean.



### 4.1.1 Scope of the Environmental Analysis

The environmental consequences of selecting e ither alternative may di rectly, indirectly, or cumulatively affect certain resources in some areas. As required by regulations implementing the NEPA promulgated by CEQ (CEQ 1978), an analysis of the environmental consequences discusses the direct and indirect effects of a proposed action, and their significance. APHIS’s agency-specific NEPA regulations refer to CEQ guidance in defining environmental consequences (USDA 2013b) 25 . Direct effects 26 are defined by the CE Q as those “which are caused by the action and occur at the same time and place.” Indirect effects 27 are defined as those “which are caused by the action and are later in time or farther remove d 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.”

24 Appendix A of the Petition lists permits/authorizations in chronological order. 25 Section 372.4, Definitions 26 Section 1508.8, Effects , Paragraph (a) 27 Section 1508.8, Effects , Paragraph (b)– 64 – The potential impacts to the resources described in Chapter 2 were analyzed, 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 addr essed in APHIS’s NEPA evaluatio ns of their plant pest risk decisions. Resources that have no potential to be affected by the Preferre d Alternative, such as coastal zones or ambient noise, are not addresse d in this report. The Preferred Alternative’s potential direct or indirect effects from SYHT0H 2 soybean as a stand-alone product (i.e., not combined with other transgenic traits through breeding; potential impacts from stacked traits are addressed in Chapter 5, Cumulative Impacts ) on the analyzed resources were compared to how those resources may be affected if the No Action Alternative is selected. 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. Specific inform ation about the three herbicides that SYHT0H2 is tolerant of is provided in the appendices.

The geographic scope of this analysis included any US land currently producing soybean or producing crops that could incorporate a soybean rotation, land that could be converted from inactive cropland to active cropland, and land cu rrently in the Conservation Reserve Program (CRP) that could be removed from the program and farmed for soybean. Geographic areas outside of the US were not considered in this repor t, except to address fo reign trade impacts.



### 4.1.2 Methodology

The potential direct and indirect effects of the No Action Alterna tive were evaluated by a review and analysis of published literature (peer-reviewed technical articles, industry information, and agency data). The potential direct and indirect eff ects of the Preferred Alte rnative to physical and biological resources were determined by laboratory analyses and field studies, as described in the Petition (Syngenta 2012c), supported by literature review and analysis. Potential direct and indirect effects of the Proposed Action to public health and socioeconomic concerns were determined by literature review and analysis. All information sour ces are cited and full references are provided in Chapter 9.

The analysis of direct e ffects from the Preferred Alternative is focused on potential changes to the environment that may occur as a direct result of the introduction of a new transgenic organism, SYHT0H2 soybean, into the market. The analysis of indirect effects from the Preferred Alternative is focused on the potential changes in the envi ronment that may occur as a result of this introduction, such as changes in ag ronomic practices. The potential di rect or indirect effects would be the incremental difference between the existi ng conditions and any new conditions that would be realized from those changes. This analysis does not consider the historical changes to the environment that have occurred in the past; the cumulative effects analysis in Chapter 6 addresses that perspective.

A likely indirect effect of dere gulating SYHT0H2 soybean is a chan ge 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– 65 – glufosinate-ammonium or phosphinothricin). Mesotrione and isoxaflutole 28 are not currently used on soybeans commercially 29 ; glufosinate is currently used on ce rtain deregulated herbicide-tolerant soybean varieties but not commonly. Descriptions of these three herbicides and their uses and potential impacts on human health and the environment are appe nded to this doc ument. These appendices are based primarily on EPA studies a nd regulatory actions since herbicide usage is regulated by EPA, not APHIS. In this document, the indirect effects analyses summarize the impacts that may result from changes in herbicide use.



### 4.1.3 Assumptions

The analysis of the potential environmental conse quences of the No Action Alternative was based on the assumption that regulated field trials of SYHT0H2 soybean on small plots of land, as described in the Petition, would continue. Th e analysis of the potential environmental consequences of the Preferred Alternative was based on the assumption that there would be full commercialization of SYHT0H 2 soybean to US growers. As noted above, the analyses of direct or indirect effects of the Proposed Action are base d on SYHT0H2 soybean in the absence of stacking with other transgenic traits. The cumulative effects analysis provided in Chapter 5 was based on an assumption of unlimited marketing of SYHT0H 2 soybean as a product stacked with other transgenic traits.

The consequences of both alternatives were evaluated using the SYHT0H2 soybean phenotype described in the Petition. Laboratory, greenhouse, growth chamber, and fiel d investigations with SYHT0H2 soybean confirmed that there were no changes in seed, pollen, plant phenotype, or composition parameters suggestive of increased pl ant pest risk (Syngenta 2012c). The seed from SYHT0H2 soybean differs slightly from that of it s nontransgenic, near-isogenic counterpart but the nutrient and antinutrient composition of SYHT0H2 soybean is not materi ally different from that of conventional soybean (Syngenta 2012c).

The environmental consequences of the two alterna tives were analyzed under the assumption that the majority of farmers who grow transgenic, nontrans genic, or organic soybean are using reasonable, commonly accepted best management practices for th eir chosen system and varieties during soybean production. These management practices include standa rd planting dates, seeding rates, harvest times, and pest management methods as well as preservation and coexisten ce measures. It is assumed that herbicides will be applied in accordance with EPA-approved label re quirements. It is also assumed that the stewardship plan provided in Appendix F of th e Petition will be implemented by the Petitioners and growers will comply with the plan in accord ance with the Technology Use Grower Agreement provisions.

The environmental consequences of both the No Action Alternative and th e Preferred Alternative were evaluated in the context of conventional soybean and existing transgenic soybeans developed

28 Bayer CropScience’s FG72 soybean (OECD Unique ID MST-FGØ72-2) is a transgenic variety with tolerance to isoxaflutole (and glyphosate); APHIS has been petitioned to deregulate this product and is currently conducting a review of the petition. 29 Mesotrione is currently registered for pre-emergence use on certain soyb ean varieties that exhibit natural tolerance to mesotrione, however this use is currently not on any marketed label and is not being used commercially.– 66 – with traits conferring herbicide to lerance. No other transgenic soybean cultivars containing the oatderived transgene avhppd-03 , which conveys tolerance of mesotrione and isoxaflutole, have been deregulated by APHIS. 30 Table 2-1 lists deregulated transgenic soybean products 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 these crops are marketed as singletrait products; one product contains both a glyphosate-tolerance trait and an acetolactate synthaseinhibiting trait. Some of these cultivars are currently on the market and some have been discontinued or were never commercialized.

As described in Section 2.1, Soybean Biology , four additional petitions for deregulating herbicidetolerant soybean cultivars are currently pending an APHIS decision; the companies, traits, and products are:

 Bayer CropScience: glyphosate and isoxa flutole tolerance; MST-FGØ72-2;

 Dow AgroSciences: 2,4-D and glufosinate tolerance; DAS-68416-4;

 Monsanto: dicamba tolerance; MON-877Ø8-9; and

 Dow AgroSciences; 2,4-D, glyphosate, a nd glufosinate tolerance; DAS-444Ø6-6.

Draft Environmental Assessments have been published by APHIS for two of these soybean products, MST-FGØ72-2 and DAS- 68416-4 soybean. As describe d above, the environmental impacts of isoxaflutole (for use on MST-FGØ7 2-2 soybean) and glufosinate (for use on DAS68416-4 soybean) presented in these two EAs are taken into consider ation, along with the impacts of mesotrione, in determining the indirect effects of deregulating SYHT0H2 soybean. The appended descriptions of these three herbicides provide information on their uses and potential impact to human health and the environment.

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 comp rise 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. The indirect effect s analysis of this Chapter ther efore presents the impacts from changes in herbicide use in qualitative, rather than quantitative, terms.



### 4.2 Soybean Production

This section describes the potential impacts 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 that may result from the No Action Alternative and the Preferred Alternative as compared to the existing conditions described in Chapter 2.

30 APHIS has issued a Draft EA for deregulation of MST-FGØ72-2 soybean, which has an HPPD gene from another source.– 67 – 

### 4.2.1 Acreage and Areas of Soybean Production

Substantive changes in soybean production acreage an d 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 re latively high soybean commodity prices, is increasing (USDA-ERS 2012g). In response, tota l 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 (USD A-OCE 2011). Approximately 93 percent of the current acreage is planted with transgenic varietie s, virtually all being herbicide tolerant (USDANASS 2011b). In order to accommodate the incr ease of US soybean acre age in spite of a net decrease in available US agricultural land (U SDOE-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 lie u of previously uncultivated land for additional soybean acreage is a land-use decision made by gr owers, as soybean is profitably grown on high quality arable land but not on land of lo wer 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 Bill 31 reduced CRP lands from 39.2 million acres to 32 million acres. 32 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 so ybean production woul d 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 Acti on 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 co nverted to soybean pr oduction woul d 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. Re gulated 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 unlik ely to disrupt the relationship between market forces and soybean acreage, which is affect ed by growing demand for soybean commodity products (USDA-ERS 2010b, 2011c ). SYHT0H2 soybean would not expand soybean acreage beyond projected values because it requires si milar management conditions as other soybean

31 Food, Conservation, and Energy Act of 2008 . Public Law 110-234. 32 Section 2103, Paragraph (3)– 68 – varieties, does not present any yield gains over ot her soybean varieties, and exhibits no phenotypic characteristics that would be indicative of an im proved capacity to grow outside an agricultural environment (Syngenta 2012c). Similar to currently available soybean varieties, SYHT0H2 soybean will require cultivation on high qua lity 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 2010e, 2011c).

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 w ould not be affected by this alternative. Current trends in the acr eage and areas of soybean production are likely to continue to be driven by mark et conditions and federal policy if SYHT0H2 soybean is deregulated.



### 4.2.2 Agronomic Practices

Potential changes in agronomic practices, including cropping practices, irrigation, fertilization, and pesticide use, are described belo w 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 i ndirectly 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 producti on system (Gianessi 2005) . Transgenic soybean varieties offer a range of herbicide tolerance trai ts 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 chan ge as a result of introducing a new herbicidetolerant transgenic soybean variety to the market.

As described in Section 2.2.2.1, Cropping Practices , crop rotation can improv e yield and profitability over time, control weeds, break dis ease cycles, limit insect and othe r pest infestations, provide an alternative source of nitrogen, redu ce soil erosion, increase soil or ganic matter, impr ove 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 contaminat ion of surface water (Al- Kaisi, Hanna, and Tidman 2003). Approximately 85 percent of the soybean-planted ac reage is in some fo rm of a crop rotation system (Quinby et al. 2006); tran sgenic soybean (with herbicide tolerance traits ) accounts for 93 percent of all so ybean 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 pr actices as farmers seek the most profitable crop and production method. Give n the predominance of crop rotation practices and tran sgenic soybeans, any changes in rotation practices are more likely to resu lt from economic and mark et conditions than other factors. Introducin g a new transgenic soybean tolerant of a different class (or classes) of herbicides is unlikely to have any effect on cr op rotation practices.– 69 – Other cropping practices that provide some weed control are cover crops and tillage. Both of these practices are used in conjunction w ith other weed control methods, in cluding herbicide use, as part of integrated weed management programs. Cover crops are selected for a variety of reasons; compatibility with herbicides us ed 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 prepares a field for planting and is used in large part for weed control. Farmers increased the use of conservation tillage before and cont emporaneously with the adoption of glyphosatetolerant soybean varieties (Owen 2008; Bonny 2011a). Adoption of conservation tillage for soybeans grew (at a decreasing rate) from abou t 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 20 02). Conservation tillage continued to increase following the commercialization of glyphosate-tolerant soybean in 1996, and totaled 63 percent of soybean acreage by 2007 (Bonny 2011b). These trends are likel y to be sustained by the continued use of broad-spectrum herbicides (Carpe nter 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). Fa rmers already using no-till find herbicide-tolerant seeds can be easily incorporat ed into their weed management program, but the commercialization of herbicide tolerant soybeans does not necessarily encourage adoption of notill 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 fa cilitating conservation tillage.

Some soybean growers may return to conventiona l tillage to manage glyphosate-resistant weed populations (NRC 2010) if use of that herbicide b ecomes less effective. However, in the absence of alternatives the majority of US growers are likely to cont inue 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 inglyphosate use and faci litating the continued or increased use of cons ervation tillage prac tices by controlli ng 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 enviro nmental 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 enviro nmental considerations of the– 70 – particular farmer. Regulated field trials of SY HT0H2 soybean would only impact small plots of land with no effect on cropping practices.



### Preferred Alternative
Cropping practices such as cover crops, crop an d herbicide rotation, and tillage would not change as a direct result of the Preferred Alternativ e. SYHT0H2 soybean exhibits similar agronomic performance relative to its nontransgenic parent va riety (“Jack”) and would benefit from currently practiced soybean crop rotation practices. No differences in di sease susceptibility were observed between SYHT0H2 soybean and its nontransgenic parent variety in experimental plots (Syngenta 2012c).

Soybean growers may change their use of cropping practices as an indirect result of introducing SYHT0H2 soybean because it is tolerant of a differ ent class of herbicides than the most commonly used product, glyphosate. Introduction of SYHT0H 2 soybean with mesotrione, isoxaflutole, and glufosinate tolerance would have an indirect e ffect on cropping practices by allowing farmers to use a broader range of herbicides to minimize w eed development of tole rance to any specific chemical. These herbicides are applied at differen t stages of the crops’ lif e cycles, and successive crops should not be planted when residual concentra tions 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 time limits 33 of each of the three herbicides when applied to corn are provided in Table 4-1; soybean and the most common crops gr own 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 varie ties tolerant of these herbicides are currently marketed. 34 The time constraints for applications of glufosinate take into consideration soybean varieties tolerant of this herbicide: these va rieties 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 immedi ately after an herbicide containi ng any of these three herbicides has been applied. Soybean is grow n continuously on up to 15 percen t of the fields, and the balance of soybean fields are in rotation with a range of crops (wheat, co tton, rice, sorghum, barley, oats, and dry beans). A basic tenet of in tegrated weed manageme nt is that herbicides should be rotated along with crops, to minimize the potential for deve lopment of herbicide-resistant weed biotypes. Depending upon which herbicide is used, an indirect effect of the Preferred A lternative is that crop and herbicide rotation practices should be altere d to accommodate these planting restrictions and integrated weed management recommendati ons. Syngenta’s Resistance FighterTM program 35 and Bayer’s Respect the RotationTM program 36 describe the companies’ recommended strategies to

33 There are slight variations in rotational crop informati on for different products with other concentrations or mixtures of herbicides. 34 Some varieties of soybean display a natural tolerance of mesotrione, but are not actively marketed as such. 35 http://www.resista ncefighter.com / 36 http://www.bayercrop science.us/news/respect-the-rotation– 71 – manage herbicide resistance. Th ese recommendations ar e encapsulated in the SYHT0H2-specific stewardship plan pr ovided in Appendix F to th e Petition (Syngenta 2012c).

Deregulating SYHT0H2 soybean wo uld not directly impa ct tillage. Crop and herbicide rotation practices may be altered as an indirect result of the Preferred Alternative, which would improve weed resistance mana gement practices . Deregulating SYHT0H2 soybean would indirectly facilitate the shift toward conservation tillage in soybean: SYHT 0H2 soybean is tolerant of other herbicide modes of action than the predominant herbicide, glyp hosate, and therefore pr ovides control of weeds resistant to glyphosate that would otherwise need to be controlled by other means.

Table 4-1 Examples of Crop Ro tation 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 2011; Bayer 2013, 2012)
Note: Bold type denotes soybean and the most common crops grown in rotation with soybean– 72 – 

### 4.2.2.2 Irrigation

As described in Section 2.2.2.2, Irrigation , supplemental irrigation is used in some soybean production areas, such as the western and midsouth ern states where summer weather patterns result in drought stress that makes dryl and 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 pr actices (NRC 2010). Conser vation tillage plays a major role in water conserva tion (USDA-NRCS 2006a) by re ducing evaporation rates and irrigation requirements. As discu ssed 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 al so not expected to change.



### No Action Alternative
Irrigation practices would not change as a direct or indirect resu lt 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 cl imate conditions, as well as increasing adoption of conservation tillage techniques. Regulated field tr ials of SYHT0H2 soybea n 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 ch ange as a direct or indirect result of the Preferred Alternative.



### 4.2.2.3 Fertilization
Compared to other crop plants, soybean cultivati on requires less nitrogen fertilization because of the natural nitrogen-fixing aspect of legumes. US DA-ERS estimates that less than 40 percent of soybean acres in the US receive nitrogen fertili zer (USDA-ERS 2012g, 2012e). The percentage of soybean acreage treated with nitrogen fertilizer, al ong 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 SYHT 0H2 soybean continues to remain a re gulated article, fertilization rates are likely to continue to be driven by agricu ltural production needs and th e natural characteristics of soybean. Regulated field tria ls of SYHT0H2 soybean would only impact small plots of land with no effect on fertilization rates.– 73 – 

### Preferred Alternative
A determination of nonregulated status of SY HT0H2 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 s oybean (Syngenta 2012c).



### 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 Sec tions 2.2.2.3 through 2.2.2.6. Insect injury can impact yield, plant maturity, and seed quality; inse ct 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 so ybean acreage that receives an in secticide treatment (USDA-NASS 2007).



### No Action Alternative
Trends in herbicide use would not change as a direct or indirect result of the No Action Alternative. Soybean production, and herbicide use in soybean, would remain as it is practiced today by the farming community. Herbicide types an d use rates are likely to continue to follow their current trends even if SYHT0H2 soybean con tinues to remain a regulated article, as growers will continue to have access to existing deregul ated or other new (pending deregulation) herbicide-tolerant soybean varieties and a wide range of herbicides.

Any environmental effects due to herbicide use in the agricultural production of soybean would continue on the same trends under the No Action Alternative. As described above, because several weed species have developed tolerance of herbicid es such as glyphosate, a continued increase in the number of weed biotypes that develop tolera nce to glyphosate can be expected under the No Action Alternative if a greater vari ety of weed management tools ar e not available or implemented. Other herbicide-tolerant varieties of soybeans may continue to be developed, marketed, and planted regardless of whether or not SYHT0H2 s oybean 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 curre ntly available, as listed in Table 2-1, Deregulated Transgenic Soybean Cultivars with Herbicide Tolerance Traits, 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.



### Preferred Alternative
SYHT0H2 soybean is agronomically equivalent to 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– 74 – SYHT0H2 soybean incorporates herbicide tolera nce traits, this section focuses on potential changes in herbicide use that would indirectly result from deregulation of this product.

If SYHT0H2 soybean is deregulated, 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 use of glyphosate or other approved soybean herbicides. Soybean growers would have a new cultiv ar to use in addition to conventional varieties and the other herbicide-tolerant varieties that ar e currently available, as listed in Table 2-1, Deregulated Transgenic Soybean Cultivars with Herbicide Tolerance Traits, or any others that may be developed, deregulated, and marketed in the future.

SYHT0H2 soybean would allow the use of other broad-spectrum herbicides, as another option available to include in an integrated weed ma nagement program. Glyphosate use may be reduced but mesotrione, isoxaflutole, and glufosinate use would likel y 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. Mesotrione, isoxaflutole, and glufosinate are effective against a br oad spectrum of weeds (dicots and grasses), including several weed biotypes that have developed re sistance to glyphosate, acetolactate synthase (ALS) inhibitors, protoporphyr inogen 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.

Replacing glyphosate use with mesotr ione, isoxaflutole, and/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 app lication rates for glyphosate, mesotrione, isoxaflutole, and glufosinate is provided in Table 4-2. Because co mmercial labels for mesotrione and isoxaflutole herbicides do not currently speci fy rates for use on soybean fiel ds, application rates for these herbicides are provided as the proposed rates fo r use on tolerant soybean. These proposed rates have been submitted by Bayer an d 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., RoundUp 1 ) 1.56 5.95 Mesotrione (Callisto 2 ) 0.20 0.31 Isoxaflutole (Balance Pro 3 ) 0.094 0.094 Glufosinate (Liberty 4 ) 0.53 1.188

NS: Not Specified. Sources: 1 (Monsanto 2012) Glyphosate is r eported as pounds acid equivalent per acre 2 Syngenta proposed soybean use rate 3 Bayer proposed soybean use rate 4 (Bayer 2012)– 75 – As SYHT0H2 soybean is tolerant to a new mo de of action (HPPD inhibition) not presently available in soybean (apart from MST-FG Ø72-2 soybean, which is currently pending deregulation), two new broad-spectrum herbicides (mesotrione and isoxaflutole) would be available for soybean growers to incorporate into an integrated weed management program. Such programs are promoted by agricultural extension offices to prevent or delay the evolution of herbicide resistant weed biotypes and to prevent shif ts in local weed populations to species that are naturally tolerant of certain herbicides.

As noted in Section 3.2, Appendix F of th e Petition (Syngenta 2012c) 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 he rbicide resistance recommendations;

 Customer education and training;

 Product use information and support; and

 Monitoring of grower use of herbicides.

Specific management recommendations for weed c ontrol in soybean and corn to minimize the development of herbicide-resistant weed biotypes are:

 Always use a full rate of a residual pre-emergenc e herbicide as specified on the product label.

 Do not rely solely on post-eme rgence applications of HPPD-i nhibiting herbicides for control of target weeds; integrate other herbicides that are active on the ta rget weeds such as glufosinate-ammonium, metribuzin and fomesa fen 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 wh ich each active ingredient is effective against the most difficult-to-c ontrol 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 mi nimize the potential devel opment of weed resistance to any one herbicide. The availability of other herbicides as additional components of integrated weed management would reduce the selection pressu re on weed species to develop resistance to ot her methods of control.– 76 – 

### 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 tran sgenic 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 SYHT0H2 soybean is deregulated, specialty soybean products would continue to be protected by the identity systems established in the industry. SYHT 0H2 soybean would be produced in a manner similar to other seed soybean varieties, which are typically produced under identity preservation systems that include contract s 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), hu man dietary, and livestock products. Raw soybeans have no human or livestock feed use as they cont ain 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 dire ct or indirect result of the No Action Alternative. Raw and proc essed soybean commod ities 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 tr ials of SYHT0H2 soybean would only impact small plots of land with no effect on raw or proce ssed commodities.– 77 – 

### Preferred Alternative
Raw and processed soybean commod ities would not change as a direct result of the Preferred Alternative. Based on data described in the Petitio n, SYHT0H2 soybean is not materially different from conventional soybean in composition or nut ritional value (Syngenta 2012c). Apart from the expected weed control benefits associated with tolerance to mesotrione, isoxaflutole, and glufosinate herbicides, SYHT0H2 soybean varie ties are agronomically equivalent to their nontransgenic counterparts (Syngenta 2012c). If SYHT0H2 soybean is deregulated, raw and processed soybean commodities would continue to be handled in accordance with regulatory standards and industry practices.

Deregulating SYHT0H2 soybean would likely result in changes of herb icide use types and rates, as described above. Raw and processed soybean co mmodities may be indirectly impacted by deregulating SYHT0H2 soybean as a result of diff erent herbicide applications. Depending upon the extent of adoption of the product and applica tion of the herbicides, some portion of the commodities would have residual concentrations of mesotrione, isoxaflutole, or glufosinate instead of glyphosate. EPA registration of herbicides (inc luding mesotrione, isoxaflu tole, and glufosinate) includes establishing limits of residual concentr ations of the herbicides on food and feed commodities to protect human he alth and the environment. Cu rrent and propo sed residual concentration limits (tolerances) for registered a nd 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 orga nic 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 productio n operations must also develop and maintain an organic production sy stem plan. Excluded prod uction methods include methods used to genetically modify organism s or otherwise influence their growth and development by means not possible unde r 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 approve d for use in organic systems because it is transgenic.

Organic soybean acreage represents less than 0.2 percent of the US soybean acreage (USDANASS 2009). In contrast to othe r US organic crops, US organi c 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 2009). 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 orga nic fields, easing their weed management needs.– 78 – 

### No Action Alternative
Organic farming practices, including field mana gement 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 c ontinue to coexist in accordance with NOP requirements. Organic soybean production would c ontinue 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 practi ces will likely continue to increase. The use of coexistence measures is expected to continue. Or ganic farms would continue to benefit from the weed suppression provided by proxi mate farms with transgenic crops and low we ed 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 SYHT 0H2 soybean would only impact small plots of land with no effect on organic farming.



### Preferred Alternative
Organic farming practices, including field mana gement to avoid excluded methods and gene movement, would not change as a di rect or indirect result of the Preferred Alternative. Soybean is primarily a self-pollinated plant (OECD 2000), and th ere is no reason to suspect that the biology of SYHT0H2 soybean will increase its potential to outcross with soybea n varieties utilized in organic soybean production (Syngenta 2012c). Studies of SYHT0H2 soybean reproductive biology revealed no substantial differen ces in factors influencing reproductive potential, including pollen viability, date of emergence, date of 50 percent flowering, and date of maturity (Syngenta 2012c).

Organic soybean seed availability would be una ffected by deregulation of SYHT0H2 soybean; the seed certification programs described above would c ontinue to operate at their current level of effectiveness. Consistent with NOP standard s and practices, organic and non-organic soybean production systems would continue to coexist. Orga nic farms would continue to benefit from the weed suppression provided by proximate farms w ith transgenic crops of herbicide tolerant varieties, including SYHT0H2 soybean. Organic soybean produc tion would continue to be regulated by the NOP and driven by market conditions if SYHT 0H2 soybean is deregulated. Nonregulated status for SYHT0H2 so ybean would not change current practices of organic soybean producers or the growth of organic soybean production.

Currently, the production of organic and transgen ic 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 u nder the Preferred Alte rnative. DeregulatingSYHT0H2 soybean would not increase risks of contamination, via either pollinators or postharvest processing, because the overall percentage of transgenic soybean is not expected to increase. SYHT0H2 soybean would not present new and different i ssues than existing herbicidetolerant soybean cultivars (see Tabl e 2-1) with respect to impact s on organic farmers. APHIS has granted non-regulated status to the products listed in Table 2-1 based on a finding that these other products do not pose a plant pest risk. A determination of nonregulated status of SYHT0H2 soybean is unlikely to aff ect US organic soybean production.– 79 – 

### 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 Prefer red Alternative in this section.

As with the purity processes described above fo r seed production, specialty soybean growers and end users maintain the identity of their products by contracts, tracking a nd traceability systems, quality assurance programs, closed loop syst ems, 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 tria ls of SYHT0H2 soybean would only impact small plots of land with no effect on othe r 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 SYHT0H2 soybean is de regulated, specialty produc ts would continue to be protected by the identity-preservati on systems established in the industry.



### 4.3 Physical Environment

This section describes the potential impacts to so il, water quality, air quality, and climate that may result from the No Action Alternative and the Pref erred Alternative as co mpared 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 (NRC 2010; Holland 2004). Degraded soil structure and compos ition may lead to decreased water retention, a decrease in soil carbon aggregation and net positive carbon sequestration, and increased greenhouse gas emissions. Conservation tillage met hods can reduce these adverse effects and havebeen increasingly adopted by soybean growers, partially enabled by the capacity to apply a broadspectrum herbicide (glyphosate) over a tolerant s oybean variety (glyphosate-tolerant soybean). As discussed in Section 4.2.2, Agronomic Practices , conservation tillage in US soybean is generally associated with 30 percent or greater remain ing plant residue and reduced soil erosion and compaction.

There may be a relationship between the introducti on 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, appr oximately 27 percent of the US soybean acres– 80 – used no-till production. Approximately 50 percent of soybean acres were planted in no-till systems by 2009 (Horowitz, Ebel, and Ueda 2010).

Soil quality may be impacted by th e application of herbicides on cr ops, as an indirect effect of transgenic soybean with herbicide tolerance traits, depend ing upon the chemicals’ persistence in soil. Pre-emergence herbicide application would be dire ctly 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 biologic al 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 varietie s 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 to tal US soybean acreage (USDA-NASS 2007). Glyphosate is antic ipated to remain the most widely applied herbicide in US soybean production, continuing the current trend.

Soybean growers would continue current ag ronomic practices, and further adoption of conservation tillage methods is expected even if SYHT0H2 soybean continues to remain a regulated article. Regulated field trials of SY HT0H2 soybean would only impact small plots of land with no effect on soil characteristics.



### Preferred Alternative
Soil characteristics would not change as a direct re sult of the Preferred Alternative. The transgenic enzymes 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 2012c).

SYHT0H2 soybean production would not change land acreage or cultivation practices for transgenic or nontransgenic soybean. Growers w ould continue current agronomic practices and continue to adopt conservation tillage methods regardless of whethe r SYHT0H2 soybean is deregulated or not. Continued a doption of conservation tillage woul d 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, is oxaflutole, and glufosinate. Thus, conservation tillage trends, and its direct bene ficial 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 applie d to pre-emergence or to SYHT0H 2 soybean fields post-emergence, but would not adversely affect soil quality. Glufos inate would be applie d to SYHT0H2 soybean fields post-emergence. As descri bed in the appendices , these herbicides de grade rapidly through biotic or abiotic processes. Alth ough the DKN degradate of isoxaflutol e is more persistent than the parent chemical, soil quality will not be impacted when isoxaflut ole is used in accordance with EPA label requirements. As a prerequisite to its registration of herbic ides (including their– 81 – degradates), EPA determines that there is no unreas onable environmental risk if the end user adheres to the label use restrictions during application.



### 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 la kes 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 transferre d to water bodies after field harvest, potentially accumulating in stream or lake sediments.

Water quality may be indirectly impacted by herbic ide-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 he rbicide use are assessed by the EPA during the herbicide registration (and re-registra tion review) process and are addressed, as warranted, through EPA requirements such as ap plication 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
Water quality would not change as a direct or indi rect result of the No Action Alternative. Water quality would continue to be regul ated 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 de scribed in Section 4.2.2, Agronomic Practices . Overall herbicide concentrations in water may be reduced and water quality improve d independent of the regulatory status of SYHT0H2 soybean. Regula ted field trials of SYHT0H2 so ybean would only impact small plots of land with no effect on water quality.



### Preferred Alternative
Water quality would not change as a direct resu lt of the Preferred Altern ative. SYHT0H2 soybean does not contain any substances that have the poten tial to affect water quality. 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 qua lity would continue to be implemented if SYHT0H2 soybean is deregulated.

The appended information on the three herbicides of which SYHT0H2 soybea n is tolerant includes summaries of each chemical’s persistence in wate r. The three herbicides degrade rapidly and are therefore not persistent in surface or groundwate r but the degradates may persist under certain conditions (i.e., suboxic conditions such as grou ndwater). The longest persistence was noted for DKN: the aqueous degradation half-life of DKN was calculated to be 103 days. As described in the appendices, these herbicides and their degradates are unlikely to concentrate or bioaccumulate.– 82 – EPA evaluates risks to water quality when conduc ting 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 so ybean. Identified risks are mana ged by EPA requirements for application methods and buffer zones, as specified in EPA-a pproved labels on each herbicide product. Labels for herbicides containing isoxaflutol e, glufosinate, or meso trione will be submitted by Bayer and Syngenta to EPA for approval of us e on SYHT0H2 soybean fi elds. Based on these precautions, increased use of these products is unlikel y to result in a substantive adverse impact to water quality.



### 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 aff ect air quality by emitting vehicle exhaust, dust, and herbicide sprays. With regard to transgenic soybean with herbicide tolerance tr aits, burning, harvesting, and fertilizing practices do not va ry 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 nontrans genic varieties because di fferent herbicides would be used for transgenic varieties. Aerial application of herbicides has the poten tial to impact air quality from drift, diffusion, and volatilization of the chem icals, 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 4.2.2.5, 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 indir ect result of the No Acti on Alternative. Soybean growers would continue current trends in ag ricultural activities even if SYHT0H2 soybean continues to remain a regulated article. Applic ation of herbicides and adoption of conservation tillage practices would continue on current trend lin es 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 Alternat ive because the SYHT0H2 plant does not display any characteristics that w ould 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 time s, as part of an integrated weed management program. Vehicle exhaust emissions and dust gene ration may increase, but it is not possible to– 83 – quantify the extent. The herbicid es 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 indir ect (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 Barf oot 2005), by reducing equipment use and allowing adoption of conservation tillage methods. The permanent CO 2 savings arising from redu ced fuel use in the US attributable to transgenic herbicide-tolerant soybeans in 2008 was 290 million kilograms of CO 2 (Brookes and Barfoot 2010).

The climate can also affect agricultural crop produ ction, 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 indi rect result of the No Action Alternative. Soybean growers would continue current trends in ag ricultural activities even if SYHT0H2 soybean continues to remain a regulated article. GHG emission reductions woul d continue as other transgenic varieties are adopted by growers and they seek more energy-efficient methods of agriculture. Regulated field tria ls of SYHT0H2 soybean would only impact small plots of land with no effect on the climate. Increases or decr eases 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 acr eage or cultivation practices for transgenic or nontransgenic soybean. As described in the Peti tion (Syngenta 2012c), SYHT0H2 soybean requires management strategies similar to those for conve ntional soybean productio n, and would not affect agricultural activities that may impact climate ch ange. Growers would continue current trends in agricultural activities if SYHT0H2 soybean is deregulated. GHG emission reductions would continue as SYHT0H2 soybean and other transgenic varie ties are adopted by growers and they seek more energy-efficient methods of agricultu re. Increases or decreases in soybean yields resulting from climate change would not be affected by the Preferred Alternative.



### 4.4 Natural Biological Communiti es (Non-Target Organisms)

This section describes the potential impacts to an imals, plants, soil microorganisms, biodiversity, and gene movement in the natural environment th at may result from the No Action Alternative and the Preferred Alternative as compared to the ex isting conditions described in Chapter 2. Potential impacts to threatened and endangered specie s are separately described in Chapter 6.– 84 – 

### 4.4.1 Animals

As described in Section 2.4.1, Animals , soybean fields may be te mporarily or permanently occupied by many animals including invertebrate s, 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 soyb ean 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, Bromley, and Anderson undated). Cultural practices that d ecrease the need for herb icides 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 cultiv ars would continue to be used by growers and there would be no change in animal exposure rates outside of co ntrolled 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 di rect result of the Pref erred Alternative. If SYHT0H2 soybean is deregulated, 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 prac ticed. There would be no direct impact to animal communities as a result of soyb ean 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 2012c ). 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 cons umed food crop, and the enzymatic mode of action of Av HPPD-03 is a native feature of A. sativa HPPD, with no toxicological significance to mammals. Th e bioinformatic analysis showed that AvHPPD-03 is most similar to other HPPD proteins in co mmon food crops and does not have sequence similarity to any known or pu tative toxins. In mi ce, AvHPPD-03 was not acutely toxic when administered orally (NOAEL = 2000 mg/kg b.w. 37 ). Therefore, AvHPPD-03 is considered to be nontoxic.”

37 No Observable Adverse Effect Le vel equals 2,000 milligrams per kilogram (mg/kg) of body weight.– 85 – Similarly, as presented in Section VII.E.3, Conclusions of the Toxico logical 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 we ll-characterized, safe class of enzymes with a high de gree of substrate sp ecificity, and shows significant homology with PAT proteins from other source organisms. Bioinformatic analysis revealed no amino acid sequence similarity to a ny known toxins or other prot eins known to cause adverse effects, and PAT was not acutely toxic to mice. PAT is therefore consid ered to be nontoxic.”

Increased use of mesotrione , isoxaflutole, and glufos inate 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 animal s and habitat presented by these herbicides are described in the appendic es. These risks are manage d by proper herbicide app lication, in accordance with the EPA-approved herbicide labels.

Deregulating SYHT0H2 soybean would not directly or indirectly impa ct animals. An evaluation of ecosystem effects is pr ovided 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 pl ants. Transgenic soybean cultivars with herbicide tolerance traits allow growers to change herbic ide usage types and application rates to manage target plants (i.e., weeds) within fields. Both target and non-targ et plants may be affected by herbicides (target plants are addressed in Secti on 4.2.2). Impacts to non-target plants outside of soybean fields may result from herbicide spray drift and volatilization. Such potential impacts are managed by adherence to the application requirem ents stated on EPA-approved herbicide labels.



### No Action Alternative
Non-target plants would not be aff ected as a direct or indirect resu lt of the No Action Alternative. Weed management methods would continue follow ing current trends even if SYHT0H2 soybean continues to remain a regulated article. Weed species that typi cally inhabit soybean production systems will continue to be managed through the us e of mechanical, cultural, and chemical control methods, including the use of glyp hosate and other registered herb icides. 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 Alterna tive. 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 ex posures. No impacts to non-target plant species are anticipated.– 86 – 

### 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 nontransgeni c soybean. Target plants (i.e., weeds) would be affected by the Preferred Alternative, as intended. This alternative, by allo wing the use of herbicides with different modes of action than are currently availabl e for use on soybean, will indirec tly help prevent or delay the evolution of herbicide resistance among target w eed species, and help avoid shifts in weed populations to those that are naturally tolera nt to the predominan t soybean herbicides.

SYHT0H2 soybean would facilitate the new or incr eased 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 co mbination 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.

As explained in the appendices for the herbicid es that would be used on SYHT0H2 soybean, volatilization is not likely for thes e compounds due to th eir low vapor pressure . Spray drift has the potential to impact non-target plan ts or may affect the quality of stormwater or i rrigation water runoff. The potential risks to non-target plants presented by these herbicides (as identified by EPA’s review of toxicolo gical data) are described in the append ices. 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 determin ed that there is no un reasonable 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), require ments specify that applic ations 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 (t exture, structure, organic matter, aggregate stability, pH, and nutrient content), plant type (a s 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 so il microorganisms.– 87 – 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, Means, and Kim 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 treate d with glyphosate were heavily colonized by Fusarium compared to non-glyphosate-re sistant or glyphosate-resistant cultivars not treated with glyphosate. These studi es hypothesized that ro ot-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 i ndirect result of the No Action Alternative. Soybean cultivation would continue as currently pr acticed. Microbes in the field would continue to be exposed to common agronomic practices, including herbicide applications to soybean fields. The use of transgenic soybean w ith herbicide tolerance traits would continue following current trends even if SYHT0H2 soyb ean continues to remain a regulated article. Regulated field trials of SYHT0H2 soybean would in volve only small plots of land with controlled plant exposures. No impacts to soil microorga nisms compared to any effects from current agronomic practices are anticipated.



### Preferred Alternative
Soil microorganisms would not be aff ected as a direct result of the Pr eferred Alternative. As stated in the Petition (Syngenta 2012c), SYHT0H2 soybean phenotype characteristics do not differ substantively from its nontransgenic parent va riety 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 micr obes if the herbicides are toxic to them. As described in the appendices, studies of mesotrio ne, isoxaflutole, and glufosinate have found no to minimal impacts to soil microorganisms. The Pref erred 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 agroecosy stem (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 fr om natural vegetation.– 88 – 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 hi gh yields from their crop, and will intensively manage plant a nd animal communities thr ough chemical an d cultural controls to protect the crop from damage. The biologic al diversity in agricultural fields is therefore lower than in the surrounding habitats. Although s oybean production fields are cultivated as plant monocultures to optimize yield, the adjacent landscape may harbor a wide va riety of plants and animals. Most transgenic crops increase the produc tivity of cultivated land s, so biodiversity is protected because additional la nd is not needed for the same volume of crop production.

A qualitative and relative comparison of the poten tial for ecological impacts of herbicides can be made by calculating an “environmental impact quotie nt” (EIQ) based on the application rate and percentage of active ingredient in market ed 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 ingred ient using an algebraic equation that combines the numerical ratings assigned to eight environm ental parameters. The underlying premise of the EIQ method is to screen for potential impacts that might result fr om the interaction of toxicity and exposure. In conducting EAs of he rbicide-tolerant transgenic pl ants, APHIS has utilized the EIQ method to compare the environmental effects of herbicide usage on a relative basis (e.g., Draft Environmental Assessment, Bayer Petition 09-328-01 for Dete rmination of Nonre gulated Status of Double Herbicide-tolerant Soy bean (Glycine max) Event FG72 and Final Environmental Impact Statement, Glyphosate-Tolerant Alfalfa Events J101 and J163: Request fo r Nonregulated Status ).

In order to assess relative impacts to ecosystems, the calculation provides an “ecological” EIQ based on application rates of herbicide active i ngredients, rather than toxicity of the pure compound to fish, birds, bees, a nd 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 referen ced 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 comb ines the ecological EIQ with worker and consumer ratings based on toxicity to humans.

These ratings provide a qualitative comparison of the potential overall envi ronmental 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 us ed on soybeans, glyphosa te, has a slightly higher ecological EIQ (indicating higher environmental im pact) than the three herbicides of which SYHT0H2 soybean is tolerant.– 89 – Table 4-3 EIQ Ecological and Overall Fiel d Use Rating of Selected Herbicides

Herbicide Environmental Impact Quotient Rating 1

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 4 2a 46.8 2 pts 19.3 2b 29.0

2,4-DDichlorophenoxyacetic acid Weedone
LV6EC 3a 87.3 1.5 pts 21.8 3b 44.5

Chlorimuron Classic 4a 25.0 1.5 oz 0.5 4b 1.0

Clethodim Clethodim
2EC 5a 26.4 32 fl oz 9.0 5b 16.4

Fomesafen Flexstar 6a 22.1 1.6 pts 8.6 6b 11.5
Glyphosate Roundup 7a 48.7 44 fl oz 20.5 7b 46.9
Imazethapyr Pursuit 8a 22.9 4 oz 1.1 8b 1.9

Metribuzin Sencor DF 9a 75.0 1.34 lb 28.5 9b 69.4

Pendimethalin Prowl 10a 38.7 4.0 pts 46.7 10b 113.0

Trifuralin Treflan HFP 11a 43.0 4.0 pts 32.4 11b 72.2

Glufosinate Liberty 12a 18.2 62 fl oz 14.2 12b 30.0

Isoxaflutole Balance Pro 13a 40.5 3 fl oz 1.8 13b 3.0

Mesotrione Callisto 14a 40.0 10 fl oz 4.7 14b 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 2010) 6b- (NYS-IPM 2013e) 7a- (Monsanto 2012) 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 fo r 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 2011) 14b- (NYS-IPM 2013j)



### No Action Alternative
Biodiversity would not be affected as a direct or indirect resu lt of the No Actio n Alternative. Biodiversity within agroecosystems would continue to be affected by agricultural practices following current trends. Growers would continue to have access to deregulated herbicide-tolerant soybean varieties, and adoption of new transgenic soybean varieties would be expected to continue even if SYHT0H2 soybean continues to remain a regulated article. Animal and plant species that– 90 – typically inhabit soybean produc tion 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 tr ials 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 2012c). As desc ribed in Section 4.4.1, Animals , and Section 4.4.2, Plants , animal and plant species that typically inhabit soybean prod uction 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 rema in unchanged under the Preferred Alternative.

As shown in Table 4-3, isoxaflutol e, 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 bu t, 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 th e Natural Environment

Soybean is principally a self-pollinated species , propagated by seed (OEC D, 2010). 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 unrelate d 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 fr equency (0 to 6.3 percent as measured in experimental treatme nts) (Caviness 1966; Ray et al. 2003; Yoshimura, Matsuo, and Yasuda 2006). As de scribed in Section 2.2.5, Persistence in the Environment/Weediness Potential , cultivated soybean seed rare ly displays any dormancy characteristics and only under certain environmenta l 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 moveme nt 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 contin ue even if SYHT0H2 soybean c ontinues to remain a regulated article. Regulated field trials of SYHT0H2 soybean would only im pact small plots of land with minimal potential for exposure to sexually compa tible plants (i.e., other soybean plants) or unrelated plants. No changes in the natural gene movement characteristics of current soybean varieties are anticipated.– 91 – Soybean’s persistence in the environment and weedin ess potential would not be affected as a direct or indirect result of the No Action Alternativ e. 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 so ybean varieties are anticipated.



### Preferred Alternative
Soybean’s characteristic of limited gene moveme nt in the natural environment would not be affected as a direct or indirect result of the Preferred Alternative. As described in the Petition (Syngenta 2012c), 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 a nd soil microorganisms (Keese 2008). Should avhppd-03 or pat from SYHT0H2 soybean be integrated into a plas mid 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 bact eria. 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 weedin ess potential would not be affected as a direct or indirect result of th e 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 SY HT0H2 soybean. Germination and dormancy characteristics of SYHT0H2 soybean seed are no different than those of conventional soybean seed (Syngenta 2012c). Th e introduced traits in SYHT0H2 soybean are not intended to affect the range or frequency of soybean out crossing, and phenotypic da ta show no indication that the genetic modification resulted in enhancement of re productive characteristics of SYHT0H2 soybean compared with c onventional soybean (Syngenta 2012c).



### 4.5 Public Health

This section describes the potential impacts to huma n health, animal (livestock) health, and worker safety that may result from the No Action Alternative and the Prefe rred Alternative as compared to the existing conditions de scribed in Chapter 2.



### 4.5.1 Human Health

In theory, transgenic products could impact huma n health because of possible toxic or nutritional effects of the products, or ho w the product might change the a llergenicity 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 mark et are safe and properly labeled. Food and feed derived from transgenic products must be in co mpliance with all applicable legal and regulatory 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.– 92 – 

### No Action Alternative

Human health would not be affected as a direct or indirect resu lt of the No Action Alternative. Previously deregulated transgenic soybean w ould continue to be us ed as food for human consumption. Human exposure to SYHT0H2 soybe an would be limited to those individuals involved in cultivation under regulated conditions even if SYHT0H2 soybean continues to remain a regulated article. Regulated fiel d trials of SYHT0H2 soybean woul d only impact small plots of land with no potential for exposure to the genera l 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 deregulated, the general pub lic would primarily come in contact with the introduced transgenic proteins (i.e., AvHPPD-0 3 or PAT) through dietary exposure to food and products derived from SYHT0H2 soybean, altho ugh most processed products would contain no detectable AvHPPD-03 or PAT re sidues. The lack of human hea lth effects from the lack of changes in nutritional value, potential exposu re to constituents of SYHT0H2 soybean, and potential exposure to herbicides are described below.

The Petition (Syngenta 2012c) states that an analysis of key nutr itional components of forage and seed from SYHT0H2 soybean iden tified 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 transg enes in SYHT0H2 soybean were evident in any test. Seed, forage, and soybean meal from SY HT0H2 soybean were found to be similar in composition to those same mate rials from conventional soybea n. 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 allerg y. 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 (Synge nta 2012c). SYHT0H2 soybean was determined to be comparable to and as safe as conventiona l soybean varieties and will not pose greater health risks to soybean-allergic consum ers than nontransgenic soybean.

The Petition also states that both AvHPPD-03 a nd PAT are homologous with proteins in many species to which humans and animals are exposed daily without concern (Syngenta 2012c). AvHPPD- 03 and PAT do not share significant amin o acid similarity to known toxins and are not acutely toxic in mice. AvH PPD-03 and PAT are unlikely to be human allergens.

AvHPPD-03 is derived from a sa fely consumed endogenous protei n in a common food crop, oat (Syngenta 2012c). Oat contains no endogenous protei ns that are listed in th e Food Allergy Research and Resource Program (FARRP) Allergen Protein Database 38 and therefore is not considered to be a known allergenic food. Oat has been implicated as a pote ntial source of protei ns that cause celiac

38 http://www.allergenonline. org/databasebrowse.shtml– 93 – 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 (HealthCa nada 2007). Pure oats can be consumed by celiac dise ase patients who are othe rwise sensitive to foods su ch as wheat and barley (which contain the proteins asso ciated 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 2012c). AvHPPD-03 is not acut ely toxic in mice and has no significant amino acid sequence similarity to known toxins or alle rgens. Bioinformatic analysis and assays for digestibility, heat inactivation, and glycosylation status provided in the Petition indicate that AvHPPD-03 is unlikely to be a fo od allergen. AvHPPD-03 is not likel y 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 comm ercially available tran sgenic crops and has a permanent EPA tolerance ex emption in all crops under 40 CFR § 174.522. It has a hist ory of safe use in numerous transgenic crop varieties that ha ve been deregulated by APHIS. The PAT protein produced in SYHT0H2 soybean has been characterized and tested to determine its potential for causing adverse effects in humans and livest ock (Syngenta 2012c). The PAT protein in SYHT0H2 soybean is from S. viridochromogenes (a member of a well-cha racterized, no npathogenic group of bacteria), shows a high degree of substrate specif icity, and shows signi ficant 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 ther efore considered to be nontoxic.

PAT is also unlikely to be a food allergen. It is derived from a source or ganism 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 (S yngenta 2012c). Furthermore, PAT is produced at very low leve ls in soybean seed, its enzyme ac tivity is completely inactivated at 55°C, and it is rapidly degraded in simulated mammalian gastric and intes tinal fluids. PAT is not similar to known allergens, and little or no dietar y exposure to intact PA T protein would occur in humans or other mammals via co nsumption 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.

The Petitioners have initiated a pre-market consu ltation process with FDA and submitted a Safety and Nutritional Assessment for SYHT0H2 soybean (Syngenta 2012c). The assessment documents a lack of toxicity of the in troduced AvHPPD-03 and PAT prot eins in SYHT0H2 soybean for human and animal consumption, an d a lack of allergenicity conc erns for humans. No adverse impacts to human health, either directly or indirectly, are expected from deregulating SYHT0H2 soybean.– 94 – 

### 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 s oybean acreage in the US; herbicid es are the most commonly used pesticides on soybean. The EPA’s Worker Protec tion 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 precau tions for worker safety associated with most herbicides include:

 Personal Protective Equipmen t (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 inte rvals post application.

Large-scale cultivation of transgen ic 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 do wnward 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 th ey may be exposed and the chemical handling procedures used, as described abov e. Prior to registering a pestic ide, EPA conducts an in-depth worker safety evaluation, and imposes strict re quirements for personal protective equipment, field reentry intervals, and specific handling instructi ons for mixing, loading and applying the product.



### No Action Alternative
Agricultural workers and pesticide applicators woul d 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. Chemic al herbicide use rates would likely continue to evolve as new varieties of herbicide-tolerant transgenic soyb ean are adopted, allowing a more diverse weed management program. Worker exposure to herbicid es would be managed by following application requirements listed on product labels. Approved tran sgenic 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 th e No Action Alternative, agri cultural workers and herbicide applicators would continue to be exposed to a variety of chemicals including mesotrione, isoxaflutole, and glufosinate on crops other than soybeans.



### Preferred Alternative

The Preferred Alternative would not have a direct impact to worker safety, as the SYHT0H2 soybean does not display any char acteristics that pose a risk to wo rkers from exposure. The Preferred Alternative would likely re sult in the use of differe nt herbicides on soybean fields than currently, potentially indirectly affecting wo rkers. EPA-registered isoxafluto le, glufosinate, and mesotrione herbicides that are currently us ed on other crops would be availa ble for use by soybean growers under the Preferred A lternative. As descri bed in Section 4.2.2.3, Pesticide Use , trends in herbicide– 95 – use are likely to continue as a direct result of the Preferred Alternative. The ad dition of a new herbicide-tolerant soybea n variety would allow the use of herb icides not currentl y applicable to soybeans, diversifying the tools available to grow ers as part of an inte grated weed management program. Instead of incr easing applications of glyphosate to manage w eeds that are developing resistance to this herbicide, these other herbicid es could be used. As desc ribed in the appendices, EPA’s review of toxicological stud ies has shown that these herbicid es present no unre asonable risk to humans. EPA’s label requirements are intended to minimize or eliminat e 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 ingest ion 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 2001). The main soybe an 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 perc ent 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 lives tock 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 deri ved from natural sources, have been tested for safety, and are not expected to be toxic in mamma ls or poultry. Changes in herbicide use types or rates that could conceivably result from intro ducing herbicide-tolerant cultivars may indirectly impact livestock if safe exposure levels are exceeded.



### No Action Alternative
Animal (livestock) health would no t 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. Previously deregulated transgenic soybean will continue to be used as feed for animal consumption, and adoption of transgenic s oybean varieties would be expected to continue. Exposure to existing transgenic and nontransgenic soybean would not change under this alternative. Regulated field trials of SYHT0H2 s oybean would only impact small plots of land with no potential for expo sure 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 li vestock feed would be unchanged from current practices. SYHT0H2 soybean and soybean meal processed from raw SYHT0H2 soybeans are– 96 – nutritionally and compositionally comparable to raw and processed soybean from conventional varieties (Syngenta 2012c). SYHT0H2 soybean is exp ected to provide adequate nutrition as part of formulated diets delivered to growing livestock.

If SYHT0H2 soybean is deregulated, livestock would primarily come in contact with the introduced AvHPPD-03 and PAT proteins in SYHT 0H2 soybean through feed products derived from SYHT0H2 soybean. As de scribed in Section 4.5.1, Human Health , these proteins are not toxic. Livestock would not be adversely affect ed by consuming SYHT0H2 soybean containing these introduced proteins.

The Petitioners have initiated a voluntary pre-ma rket consultation proce ss with FDA and submitted a Safety and Nutritional Assessment for SYHT 0H2 soybean in August 2012 (Syngenta 2012b). The assessment documented a lack of toxicity of the introduced AvHPPD-03 and PAT proteins in SYHT0H2 soybean animal consumption. No advers e impacts to livestock, either directly or indirectly, are expected from deregulating SYHT0H2 soybean.

Different herbicides may be used by soybean growers as a re sult of deregulati ng SYHT0H2 soybean, potentially changing livest ock exposure to herbicid es. Potential impacts to livestock health are minimized by adherence to EPA-ap proved label requirement s. For example, the herbicide labels for Callisto® (containing mesotrione), Balance Pro® (contain ing isoxaflutole), and Liberty® (containing glufosinate) include precautions on time limits when certain crops may no t be used as forage or feed after herbicide application.



### 4.6 Socioeconomic Factors

This section describes the potential impacts to the domestic trade envi ronment, foreign trade environment, and social and economic environment that may result from th e 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 domestica lly for animal feed, with lower amounts and byproducts used for oil or fresh consumption (GIN A 2011; USDA-ERS 2010a). As described in Section 2.6.1, Domestic Trade Environment , the estimated valu e of the 2012 US soybean production to meet these demands as well as ex port requirements (described below) is $34.5 billion. In 2011, tran sgenic products comprised 93 percent of the planted soybean to satisfy this demand (USDA-ERS 2011c). The transgenic traits include he rbicide tolerance and improved oil content, as descri bed in Section 2.1, Soybean Biology . Overall, harvest security and quality are better with herbicide-tolerant soybean. Farm income is positively impacted by herb icide-tolerant soybean by reducing production costs (e.g., reduced tillage for weed manage ment 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 ar e 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 inst ructive for anticipating changes to the domestic– 97 – trade environment that may result from the in troduction of other herbicide-tolerant soybean varieties. The unprecedented high rate of accepta nce and adoption of gly phosate-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 s oybean farmers. As early as 1997, weed control costs for glyphosate-tolerant soybean adopters were lower than those incurred by nonadopters (Lin, Price, and Fernandez-Cornejo 2001). Manufacturer s 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 pe rcent (Carpenter et al. 2002). The result has been a reduction in weed control costs for bot h adopters and nonadopters of glyphosate tolerant soybean. It was estimated that in 2000, US so ybean farmers would spend $307 million less on weed control than in 1995 (Carpenter and Gian essi 1999). A recent economic impact for one weed control system (comprised of a combination of he rbicides and herbicide-tolerant corn, cotton, and soybean) estimated that adoption of the system could add $1.9 billio n 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 so ybeans, there was little im pact on net fa rm returns in 1997 and 1998 (Fernandez- Cornejo and Caswell 2006). It may be that the adopti on of herbicidetolerant soybeans is associated with increa sed off-farm household income , suggesting that farmers adopt this technology becau se the simplicity and flexibility of the technology permit them to save management time, allowing them to benefit from additional inco me 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 dependen t on the soybean su pply elasticity (Fernandez-Co rnejo and Caswell 2006).



### No Action Alternative

The domestic trade environment would not be affected as a direct or indirect re sult of the No Action Alternative. Growers woul d continue to make choices to plant certain soybean varieties and use certain crop rotation practic es based on factors such as yield, weed, disease and other pest pressures, cost of seed and other in puts, technology fees , worker safety, potential fo r crop injury, and ease and flexibility of the production syst em (Gianessi 2005). Th e No Action Alternativ e 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. Regu lated field trials of S YHT0H2 soybean would only impact small plots of land with no impact on the dome stic trade environment.



### 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 deregulated, potentially reducing economic loss from weed competition and economic cost from weed control. More effectiv e weed manageme nt offered by– 98 – expanding an integrated weed management pr ogram would minimize yield losses and help preserve the efficacy of we ed 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, potent ially resulting in lower se ed prices for growers. The option to use diffe rent 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 s oybean export destinations include China, Mexico, Japan, and Indonesia. These countries do not ha ve major barriers for importing food or feed commodities produced from transgenic crops, including those with herbicide to lerance traits. Soybean exports to European Union countries have genera lly declined since the Co mmon Agricultural Policy limited grain imports and EU membership has e xpanded (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 woul d 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 enviro nment. Regulated field trials of SYHT0H2 soybean would on ly impact small plots of land with no im pact 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 co nditions and destinat ion country ap proval of transgenic crop commodities would continue to be factors for international soybean prices, without regard to the presence or absence of SYHT0H2 soybean on th e market. Deregulating SYHT0H2 soybean would not adversely impact th e foreign trade economy and may potentially enha nce it through more efficient producti on of soybean su pplies worldwide.

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 f ilings for SYHT0H2 soybean impor t approvals have been made in Canada, Argentina, Japan, Repub lic of China, South Korea, Repu blic 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. Th e foreign trade economic impacts associated with the deregulation of SYHT0H2 soybean are anticip ated to be very sim ilar to the No Action Alternative.– 99 – 

### 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 choos e from, and opportunities for sale to customers. Consumers have a range of soy produc ts 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 c onsumer 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 rema in 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 af fected as a direct or indirect result of the Preferred Alternative. Regulatory programs and consumer choice would be unchanged by granting non-regulated status to SYHT0H2 soybean.– 100 – This page intentionally left blank.– 101 – 

## 5 CUMULATIVE EFFECTS

This Chapter describes the pot ential 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 co llectively significant im pact on the environment when added to other past, present, a nd 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 wh en added to other past, present, and reasonably foreseeable future actions regardless of what agen cy (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.” Fo r example, for USDA-APHIS cumulative effects may include the impacts associated with a determination of nonreg ulated status of a ge netically engineered crop in combination with the future production of crop seeds with multiple traits that are no longer subject to the regulatory requireme nts of 7 CFR part 340 or the plan t pest provisions of the PPA. A cumulative impact may also result from the use of an he rbicide with a similar mode of action to that of the intended herbicides de scribed in the Petition for nonregulated status.

Based on the information provided in Sections 4.2 through 4.6, whic h is summarized in Table 3-1, the Preferred Alternative would not have substantiv e direct or indirect adverse impacts to soybean production practices or the physical, natural, soci al, or economic environm ent. If SYHT0H2 soybean is deregulated, some resources may be beneficially impacted to a minor degr ee, as compared to the No Action Alternative. This cumulative effects eval uation reviews only those resources that may be directly or indirectly impacted by deregulating SYHT0H2 soybean, whether the impacts are adverse or beneficial. Resources that woul d not be impacted by the Preferre d Alternative are not subject to the cumulative effects evaluation.

In the event that APHIS reaches a determination of nonregulated status, SYHT0H2 soybean could be combined (“stacked”) with nontransgenic and transgenic soybean cultivars that are no longer subject to the regulatory requireme nts of 7 CFR part 340 or the pl ant 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 pet itions for deregulation are in review. This could result in a plant variety that, fo r 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 previously deregulated transgenic soybean varieties, nor over stacked varieties combining dere gulated transgenic cultivars, unless it can be positively shown that such stacked varieties are lik ely to pose a plant pest risk. All deregulated transgenic soybean cultivars have been subject to APHIS’s review and received a “finding of no significant impact.” Any herbicides that would be used on a stacked product have been subject to EPA’s registration process and review for impact s to human health and the environment; approved herbicides pose little risk when used in acco rdance with label requirements. This cumulative effects analysis therefore evaluates the combinati on of the transgenic traits that may occur from– 102 – SYHT0H2 soybean stacked with other traits, and th e 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 foll owing sections discuss the potential cumulative impacts to selected resources that may result from th e direct and indirect effects of deregulating SYHT0H2 soybean when combined with other past, present, and reasonably foreseeable future actions. There is no indication in the Petition (Syn genta 2012c) that SYHT 0H2 soybean will be stacked with any particular deregulated tr ansgenic variety, as company plans, third-party licensing negotiations, and market demands play a significan t role in those busi ness decisions. Pred icting all potential combinations of stacked varieties that could be created using both deregulated transgenic soybean cultivars and nontran sgenic soybean cultivars is hypo thetical and speculativ e. Because it is not possible to identify specific varietie s 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 SY HT0H2 soybean is not anticipated to have a cumulative effect on agronomic practices i nvolving either cropping practices or weed management. As describe d 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. Dere gulated transgenic soybean varieties have not differed substantively from nontransgenic so ybean in agronomic requirements and pest sensitivities, and SYHT0H2 soybean is similar as well (Syngenta 2012c ). It is unlikely that there would be any cumulative effect on soybean cropping practices rela ted to growing the plant as a result of stacking SYHT 0H2 soybean with any other curren tly available soybean product.

Herbicide use patterns and application rates may change beyond those anticipated in Section 4.2.2.3, Pesticide Use . If SYHT0H2 soybean is deregula ted, farmers may apply any of the three herbicides of which SYHT0H2 soybean is tole rant: mesotrione, isoxaflutole, and glufosinate. These applications would occur in combination w ith, or possibly in place of, other herbicides registered for use on soybeans. Although HPPD-inhi bitor herbicides other than mesotrione and isoxaflutole exist, SYHT0H2 soybean has not demo nstrated tolerance to commercial application rates of other HPPD-inhibitor herbicides registered by EPA. It is therefore unlikely that any other currently registered HPPD-inhibiting herbicid es would be substituted for mesotrione or isoxaflutole for use on SYHT0H2 soybean. Furthe r, there are no other glutamine synthetaseinhibiting herbicides besides glufosinate (which is also known as glufosinate-ammonium and phosphinothricin) that could be used on SYHT0H2 soybean.

It is possible that SYHT0H2 soybean could be stacke d with other deregulated transgenic traits that confer tolerance to herbicides with other modes of action. As described in Section 4.2.2.3, Pesticide Use , overall herbicide application rates (as m easured 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 S YHT0H2 soybean with other traits that confer tolerance to herbicides with di fferent modes of action would of fer growers greater choices in– 103 – herbicide programs and advance integrated weed management practices. Any herbicides that would be used in this scenario would have b een registered with EPA and approved for use on soybeans; substantive changes in herbicide applic ation practices are therefore unlikely. Agronomic practices would only be minimally altered by using previously approved herbicides on SYHT0H2 soybean fields. Deregula ting SYHT0H2 soybean would not ha ve a cumulative effect on agronomic practices.

Weed populations can change in response to farm-lev el agronomic practices, including weed management decisions, as has be en seen with the development of glyphosate-resist ant weeds as a result of the predom inant use of glyphosate. An integrated weed management syst em, incorporating a range of herbicides that use di fferent modes of action , will minimize the development of weeds resistant to any one herbic ide or herbicide class. Fu rther, herbicide use (and indirectly, the use of herbicide-tolerant crops) should be a component of a broader integrated weed management system (Mortenson et al. 201 2). Integrated weed management incorp orates a number of practices, including the use of cover and rotational crops, tillage, an d herbicide applications to reduce selection pressure and weed populations in an agricultural environment (Morte nson et al. 2012 ). Cult ivating SYHT0H2 soybean and usi ng a broader range of he rbicides as a result of the Preferred Action Alternative will facilita te a more comprehensive approach to weed manage ment than is currently possible. Preemptively incorporating integrated weed management measures (as described in the stewardship plan presente d as Appendix F of the Petition (Syngenta 2012c)) may prevent or delay the development of resistant weed populations.

Utilized within an integrated weed management system and within the context of best management practices, SYHT0H2 soybean would offer soybean growers new herbicide options and facilitate the control of glyphosate-resistant weed populations while also preventing or delaying the rate of development of other herbicide resistance. Herbic ide rotation practices woul d be implemented as a requirement of the stewardship plan. The cumula tive effect on weed management as a result of deregulating SYHT0H2 soybean could minimize th e development of new populations of weed species with herbicide resistance and the preservation of herbicide efficacy.



### 5.3 Water Quality and Use

A determination of no nregulated status for SYHT0H2 soybean is not anticipated to result in an adverse cumulative effect on water quality. As desc ribed in Section 4.3.2, Water Quality and Use, deregulating SYHT0H2 soybean woul d not have any direct effect or substantive adverse indirect effect on water resources. Stacki ng SYHT0H2 soybean with other he rbicide toleranc e traits would allow other herbicides to be used on SYHT0H2 soybean crop s. Any herbicides that would be used in this scenario, such as glyphosate, would have already been register ed with EPA and approved for use on soybeans. Glypho sate, currently the most extensively used herbicide, has relatively low impacts to soil and water quality compar ed to many other herbicides (Cerdeir a 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.– 104 – Based on these precautions, deregulating SYHT0H2 soybean would not have an adverse cumulative effect on water quality.



### 5.4 Soil

A determination of nonregulated status of SYHT 0H2 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 advers e effect on soil quality. SYHT0H2 soybean will contribute to the continued trend toward conserva tion tillage, an agricultura l practice with strong direct and positive effects on soil quality (Holland 2004; NR C 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 ma y be used on SYHT0H2 so ybean as part of an integrated weed management program could allow furthe r use of conservation tillage.

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. Deregulating SYHT0H2 so ybean would not have a cumulative adverse effect on soil.



### 5.5 Air Quality

A determination of no nregulated status for SYHT0H2 soybean is not anticipated to result in an adverse cumulative effect on air quality. As desc ribed in Section 4.3.3, Air Quality , deregulating SYHT0H2 soybean would not have any direct or indirect advers e 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 EP A and approved for use on soyb eans. Air quality would not be adversely affected by using othe r previously approved herbicides on SYHT0H2 soybean fields. Air quality could benefit from in creased use of cons ervation tillage pr actices, decreasing dust emissions. Deregulating SYHT0H2 s oybean would not ha ve a cumulative advers e effect on air quality.



### 5.6 Plants

A determination of nonreg ulated 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 indirect ly affect them through changes in herb icide use. The he rbicides that would be newly available for use on soybeans are toxic to target plants (weeds) and some non-target pl ants; these characteristics generally apply to all herbicides. Stacking SYHT0H2 s oybean 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 herbic ides that would be us ed in this scenario would have already been registered with EPA and appr oved for use on soybeans. EPA cond ucts an in-depth analysis of the potential impacts of pesticides to non-t arget plants based upon an exte nsive data set, and sets– 105 – restrictions to ensure there is no unreasonable harm to non-target plants. Wh en the herbicides are used in accordance with label requi rements, non-target pl ants would therefore be unaffected by using previously approved herbicides, such as glyphosate, on SYHT0H 2 soybean fields. Deregulating SYHT0H2 soybean would not have a cumulati ve adverse effect on non-target plants.



### 5.7 Soil Microorganisms

A determination of nonregulated status of SYHT 0H2 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-approve d transgenic traits potentially stacked with SYHT0H2 soybean do not adversely impact so il microorganisms. Stacking SYHT0H2 soybean with other transgenic traits, including those conf erring herbicide tolerance, would not adversely impact soil microorganisms. All he rbicides 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. Deregulating SYHT0H2 soybean w ould not have a cumulative adverse effect on soil microorganisms.



### 5.8 Biodiversity

A determination of nonregulated status of SYHT 0H2 soybean is not anticipated to result in an adverse cumulative effect on biodiversity. Cultivati ng 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. Deregulating SYHT0H2 soybean would not have a cumulative adverse effect on biodiversity.

Using transgenic soybean varieties containing he rbicide-tolerance traits may improve biological diversity by facilitating the use of conservatio n tillage practices (Bonn y 2011a; NRC 2010), which, in turn, can improve soil porosity, enhance soil faun a and flora, increase th e flexibility of crop rotation, and facilitate strip cropping (Fernandez-Co rnejo, Klotz-Ingram, and Jans 2002). Each of these contributes to the health of the faunal an d floral communities in an d around soybean fields, thereby promoting biodiversity (Palme r, Bromley, and Anderson undated).



### 5.9 Domestic Trade Environment

A determination of nonregulated status of SYHT 0H2 soybean is not anticipated to result in an adverse cumulative effect on the domestic trade environment. As descri bed in Section 4.6.1, Domestic Trade Environment , deregulating SYHT0H2 soybean would not have a direct or indirect adverse impact on the domestic trade environmen t. Domestically produc ed 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 substantiv ely affect the market of transgenic products.– 106 – Market use of soybean is ofte n dependent on the soybean va riety, and the resulting nutrient composition. There are compositional differences am ong some soybean varieties grown for animal feed and those for human consumpt ion. These include the soybean va rieties 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 tr aits would likely be similar to that of other soybean products currently on the market. This approach would likely ha ve a minor beneficial impact on the domestic trade market as a result of increased competition. Deregulating SYHT0H2 soybean would not have an adverse cumulative effect on the domestic trade environment.– 107 – 

## 6 THREATENED AND EN DANGERED SPECIES

The Endangered Species Act (ESA) 39 establishes the Federal program to protect threatened and endangered species. Once an animal or a plant is added to the list of threatened or endangered species, protective measures apply to the species a nd its designated critical habitat. These measures include protection from adverse effects of Federa l activities, such as APHIS’s determination of non-regulated status for transgenic crops. Sec tion 7(a)(2) of the ESA requires that Federal agencies, in consultation with the US Fish and Wildlife Serv ice (USFWS) and/or the National Marine Fisheries Service (NMFS), ensure that any action they authorize, f und, or carry out is not likely to jeopardize the continued existence of a list ed species or result in the destruction or adverse modification of designated critical habitat. It is the responsibility of the Fe deral agency taking the action to assess the effects of their action and to consult with the USFWS if it is determined that the action “may affect” listed species or critical habitat.

To facilitate APHIS’ ESA consu ltation process, APHIS met with the USFWS from 1999 to 2003 to discuss factors relevant to APHIS’ regulator y authority and effects analysis for petitions for nonregulated status, and developed a process for conducting an effects determination consistent with the PPA (USDA-APHIS undated) . APHIS uses this pr ocess to help fulfill its obligations and responsibilities under Section 7 of the ES A for biotechnology regulatory actions.

APHIS’ regulatory authority over genetically engi neered organisms under the PPA is limited to those organisms that it has reason to believe migh t be plant pests or thos e for which APHIS lacks sufficient information to determin e that the organism is unlikely to pose a plant pest risk (7 CFR part 340.1). APHIS does not have the authority to regulate the use of any herbicide, including mesotrione, isoxaflutole, or glufosinate. After co mpleting a plant pest risk assessment (PPRA), if APHIS determines that SYHT0H2 soybean does not pose a plant pest risk, then SYHT0H2 soybean would no longer be subject to th e plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 340, and ther efore APHIS would reach a determination that the article is no longer regulated. As part of its EA process, and in co mpliance with the ESA, APHIS assesses the potential effects of SYHT 0H2 soybean on the environment including any potential effects to threatened and endangered species and designated critical habitat. APHIS thoroughly reviews information about the genetically engineered product and data related to the organism. For each transgenic plant, APHIS consid ers the following information in its analysis:

 The biology, taxonomy, and weedin ess potential of the crop plan t and its sexually compatible relatives;

 Characteristics of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;

 Where the new transgene and its products ar e produced in the plan t and their quality;

 The agronomic performance of the plant, in cluding disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;

39 16 USC Section 1531– 108 –  Determination of the concentra tion of known plant toxicants; and

 Determination whether the transgenic plant is sexually compatible with any threatened or endangered plant species.

This Chapter provides an evaluation of the potential effect s that a determination of nonregulated status of SYHT0H2 soybean may have, if any, on Federally listed threatened or endangered species, and species proposed for listing, as well as designated cr itical habitat and habitat proposed for designation. Based on the soybean production ar eas identified in Section 2.2.1, Current and Projected Acreage and Range of Soybean Production , the USFWS list of threatened or endangered species (listed and proposed) for each state where soybean is commercially produced (source) has been reviewed. Section 4.2.1, Acreage and Areas of Soybean Production , considers the potential for SYHT0H2 soybean to extend the range of soyb ean production and also the potential to extend agricultural production into new natural areas. The st udies described in the Petition demonstrate that agronomic characteristics and cultivation practices required for SYHT0H2 soybean are essentially indistinguishable from practices used to grow other soybean vari eties, including other herbicidetolerant varieties (Syngenta 2012c). Although SYHT0H2 soybean is expect ed to replace other varieties of soybean currently cultivated, the Petitioners do not expect that the cultivation of SYHT0H2 soybean would result in new soybean fields to be planted in areas that are not al ready devoted to soybean production. Accordingly, the issues discussed in th is chapter focus on the potential environmental consequences of the determination of nonregulated status of SYHT0H2 soybean on threatened or endangered species in the areas wh ere soybean is currently grown.

This Chapter focuses on the implications of exposure to the AvHPPD-03 and PAT proteins in SYHT0H2 soybean, the interactions between threatened or endangered species and SYHT0H2 soybean (including the potential for se xual compatibility and the ability to serve as a host for a threatened or endangered species). In addition, this Chapter di scusses potential impacts to threatened or endangered species from the use of mesotrione, isoxaflutole, and glufosinate herbicides as an indirect result of SYHT0H2 so ybean cultivation. More information about each of these herbicides is provided in the appendices.



### 6.1 Potential Effects of SYHT0H2 Soybean on Threatened or Endangered Species

6.1.1 Threatened and Endangered Plant Species

The agronomic data provid ed in the Petition were used in the analysis of weediness potential for SYHT0H2 soybean and further evaluated for the po tential to impact threatened or endangered species. Agronomic studies tested the h ypothesis that the weediness potential of SYHT0H2 soybean is unchanged with respect to conventional soybean. No differences were detected between SYHT0H2 soybean and conv entional soybean in growth, reproduction or interactions with pests and disease, other than th e intended effect of herbicide tolerance (Syngenta 2012c). The weediness potential of soybean is low, due to domestication syndrome traits that generally lower overall fitness outside an agricult ural environment. Mature soybean seeds have no innate dormancy, are sensitive to cold, and are not expected to surviv e in freezing winter– 109 – conditions (OECD 2000). Soybean has been cultiv ated around the globe without reports of weediness or persistent feral populations (M allory-Smith and Zapiola 2008). Soybean cannot survive in the majority of the US without human intervention, an d it is easily controlled if volunteers appear in subsequent crops. SYHT0H2 soybean does not present a risk of weediness and does not present an increased risk of gene flow when compared to other currently cultivated soybean varieties. Based on the agronomic field data and a literature survey on soybean weediness potential, SYHT0H2 soybean is unlikely to aff ect threatened or endangered species as a troublesome or invasive weed.

As discussed in Section 4.4.5, Gene Movement in the Natural Environment , there is no risk to related plant species from the cultivation of SY HT0H2 soybean. Soybean is highly self-pollinating and can only cross with other members of Glycine subgenus Soja . Wild soybeans are native to China, Korea, Japan, Taiwan, and the form er USSR. In the US, there are no wild Glycine species (i.e., Glycine species are not found outside of cultivation), and the poten tial for outcrossing is nil. Based on the list of threatened or endangered pl ant species in the US states where soybean is grown, there are no sexually compatible listed thr eatened or endangered pl ant species or speciesproposed for listing, as none of these listed plants are in the same genus nor are known to crosspollinate with species of the genus Glycine

.
Based on the agronomic field data , a literature survey on soybean weediness potential, and the absence of threatened or endangered plant species that are sexually compatible with soybean, the Petitioners have concluded that SYHT0H2 soybean will have no effect on threatened or endangered plant species.



### 6.1.2 Threatened and Endangered Animal Species

Threatened and endangered animal species that may be exposed to the transgene products in SYHT0H2 soybean would be those species that i nhabit soybean fields a nd feed on soybean. To identify potential effects on threat ened and endangered animal species, the Petitioners evaluated the risks from consuming SYHT0H2 soybean. So ybean is commonly used as a feed for many livestock. Additionally, wildlife ma y use soybean fields as a food source, consuming the plant, seeds, or insects that live on the plants. Howeve r, threatened or endangered animal species are generally found outside of agricultu ral fields. Few if any threatened or endangered animal species are likely to use soybean fields b ecause they do not provide suitable habitat. As noted in previous studies by APHIS (USDA-APHIS 2012a, 2012b), whooping crane ( Grus americana ), sandhill crane ( Grus canadensis ), piping plover ( Charadrius melodius ) and interior least tern ( Sternula antillarum ) are the only threatened or endangered anim al species that potentially visit soybean fields during migratory periods. These species would not be present during normal farming operations. In a study of soybean consumption by w ildlife in Nebraska, results indicated that soybeans do not provide the high-en ergy food needed by cranes and th at cranes primarily feed on cultivated grains (particularly corn) during migrat ion (Tacha, Vohs, and Iv erson 1987). Least terns feed over water, principally on small fish, but also eat aquatic insects (Thompson et al. 1997). Piping plover also feed entirely on invertebrates (T hompson et al. 1997). None of the listed species are likely to feed on so ybean plants or seeds.– 110 – The Delmarva Penninsula 40 fox squirrel ( Sciurus niger cinerus ) inhabits mature forests of mixed hardwoods and pines, which may be found adjacent to agricultural areas of the Delmarva Peninsula (USFWS 2013a). This species feeds primarily on acorns, nuts, and pine seeds and is not likely to utilize soybeans to any extent. The Louisiana black bear ( Ursus americanus luteolus ), which occurs in Louisiana, Mississippi, and Texa s (USFWS 2013b), may occasionally forage on soybeans but prefers crops such as corn, su garcane, and winter wheat (USFWS 2009).

SYHT0H2 soybean is genetically engineered to produce the proteins AvHPPD-03 and PAT , and thereby displays tolerance to mesotrione, isoxaflu tole, and glufosinate herbicides. 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 ri sk to non-target organi sms. HPPD proteins are ubiquitous in plants, animals and microbes, and are not novel. PAT has been previously analyzed and approved by several international regulatory agenci es, thus demonstrating th at it is not likely to have any significant effect on animal health (USDA-APHIS 2012b). PAT has been assessed in multiple transgenic crops, as listed in Tables V II-2 and VII-3 of the Petitio n (Syngenta 2012c), and shown to present no food or feed safety risk.

In addition to establishing that AvHPPD-0 3 and PAT are nontoxic, studies comparing SYHT0H2 soybean to its nontransgenic counterpart demonstrated no meaningful differences in agronomic or morphological characteristics (Syng enta 2012c). Compositional elements, including proximate and fiber components, vitamins, amino aci d and fatty acid content, and antinutrients and isoflavone concentrations, revealed no substant ive differences between SYHT0H2 soybean and conventional soybean varieties. These data indicat e 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 AvH PPD-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.



### 6.1.3 Conclusion

Because SYHT0H2 soybean does not produce new toxins or alter the nutritional value of soybean, there would be no direct or indirect impacts on wildlife species that feed on soybean or the associated biological food chain of organisms. Therefore, based on these analyses, it is concluded that consumption of SYHT0H2 soyb ean plant parts would have no effect on any listed threatened or endangered animal species or species proposed for listing.

The studies described in the Petition and other inform ation presented in this ER have not identified any stressor that could affect the re production, numbers or di stribution of a listed th reatened or endangered animal species or any proposed for listing. There are no effects on designated cri tical habitat or habitat proposed for designation that would differ from eff ects that would occur from the production of other soybean varieties. Soybean is not considered a pa rticularly competitive plant species and has been selected for domestication and cultivation under conditions not nor mally found in natural settings

40 The “Delmarva Penninsula” is comprised of all of Delaware and parts of Maryland and Virginia.– 111 – (Hymowitz 1970). Soybean is not sexua lly compatible with, nor serves as a host species for, any listed species or species proposed for listing. Consumption of S YHT0H2 soybean by any listed species or species proposed for listing will not result in increase d toxicity or lower nutritional value as compared to conventional soybean varieties. Based on these factors, it is c oncluded that a determination of nonregulated status for SYHT0H2 soybean, and th e corresponding environmen tal release of this soybean variety, will have no effect on listed spec ies or species proposed for listing, and would not affect designated critical habita t or habitat proposed for designation.



### 6.2 Potential Effects of the Use of Meso trione, Isoxaflutole, and Glufosinate

APHIS met with USFWS officials on June 15, 2011 to discuss wh ether APHIS has any obligations under the ESA regarding the potential effects on threat ened or endangered species of herbicide use associated with genetically engineered crops. As a result of these joint discussions, USFWS and APHIS have agreed that it is no t necessary for APHIS to perform an ESA effects analysis on herbicide use associated with genetically engi neered crops because EPA has both regulatory authority over the labeling of pe sticides and the necessary techni cal expertise to assess pesticide effects on the environment under FIFRA.

APHIS has no statutory authority to authorize or regulate the use of mesotrione, isoxaflutole, or glufosinate, or any other herbicide, by soybean growers. Under APHIS’ current 7 CFR part 340 regulations, APHIS has the author ity to regulate SYHT0H2 soybean or any genetically engineered organism only as long as APHIS believes it may pose a plant pest risk. APHIS has no regulatory jurisdiction over any potential risks re sulting from the use of herbicides or other pesticides on those organisms. However, consistent with the approach that APHI S has taken in other recent Environmental Assessments (USDA-APHIS 2012a) this section provides a synopsis of potential environmental effects on threatened or endangere d species resulting from mesotrione, isoxaflutole, and glufosinate use on SYHT0H2 soybean, based on assessments performed by the EPA and other peer-reviewed scientific literature.

EPA is required to review pesticide information and data to determine whether a pesticide product may be registered for a particular use. As part of that determination, the EPA assesses whether listed threatened or endangered species or their designated critical habitat may be affected by use of the pesticide product. All pesticide products th at EPA determines “may affect” a listed species or its designated critical habitat may be subj ect to the EPA’s Endang ered Species Protection Program.

EPA intends to evaluate listed species and their critical habitat concerns within the context of the registration review program, a mandated 15-year rolling review of every pesticide. When a registration review final decision is made, it will address potential impacts to listed species. If a risk assessment determines that use limitations are necessary to ensure that legal use of a pesticide will not harm listed species or th eir critical habitat, EPA may e ither change the terms of the pesticide registration or establish geographically specific pesticide use limitations.

EPA’s review of the pesticide and its registrati on decision are independent of APHIS’ review and regulatory decisions under 7 CFR part 340. EPA evaluates extensive data on toxicity, ecological– 112 – effects, environmental fate, transp ort and behavior data, use and usage data, and species biology to assess potential impacts to listed species and th eir designated critical ha bitats. Additionally, EPA intends to informally consult w ith USFWS and the National Marine Fisheries Service (NMFS), as needed, to incorporate more re fined species biology and habitat information. EPA intends to consult formally with USFWS and NMFS where “may affect” determin ations are made, and develop reasonable and prudent alternatives to avoid the likelihood of jeopardizing the listed species or destroying or modifying their critical habitats. Where needed, they develop reasonable and prudent measures to minimize the impact of anticipated “take” of listed species.

In March 2013, EPA announced ne w guidance on the ESA consulta tion process (USEPA 2013c). The guidance, entitled Enhancing Stakeholder Input in the Pe sticide Registration Review and ESA Consultation Processes and Development of Economically and Technologically Feasible Reasonable and Prudent Alternatives , was developed jointly by EP A, USDA, USFWS, and NMFS in the US Department of Interi or. The guidance explai ns how the agencies will implement the ESA and FIFRA in the context of pesticide registrati on review decisions. Specifically, the process of assessing the potential effects of a pesticide to federally listed threatened and endangered species, determining whether risk reduction measures are necessary to ensure these species are not likely to be jeopardized and critical habitat is not destro yed or adversely modified , and implementing such measures requires close coordina tion across multiple agencies a nd impacts a variety of entities including state pesticide regulatory agencies, pesticide users and pes ticide companies. The guidance explains how to enhance opportunitie s for soliciting and considering input from stakeholders, including state governments, univers ities, and growers/users to ensure that such measures are technologically and economically feasible.



### 6.2.1 Ecological Risks of Mesotrione

Mesotrione was first registered on June 4, 2001 (USEPA 2001a). The Food Quality and Protection Act of 1996 mandated that the EPA conduct registration reviews of all pesticides distributed or sold in the US every 15 years. EPA is expected to begin registration review for mesotrione in 2014 (USEPA 2012e).

The results of multiple ecological and human-health risk assessment s are provided in the appended information about mesotrione. In regard to animals, EPA concluded that mesotrione is:

 Considered practically nont oxic to avian species on a subacute dietary basis.

 Considered practically n ontoxic to the bobwhite on an acute oral basis.

 Categorized as practically nont oxic to small mammals on an acu te and chronic oral basis.

 Practically nontoxic to bees on an acute contact basis.

 Considered practically nontoxic to fr eshwater fish on an acute basis.

 Considered practically n ontoxic to aquatic inverteb rates on an acute basis.

 Categorized as practically nontoxic to estu arine/marine fish on an acute basis.

 Considered moderately toxi c to slightly toxic to estuarine/marine invertebrates on an acute basis.

Mesotrione is considered by EPA to be a “reduced risk” pesticid e for certain uses. The EPA risk assessment (USEPA 2001b) found th at mesotrione posed an acute (to small birds, < 10 grams in weight) and chronic risk to endangered bird sp ecies feeding in short grass habitats. EPA also– 113 – concluded that mesotrione, at its registered applica tion rates, is unlikely to present a risk to aquatic or terrestrial animals on an acute or chroni c basis. EPA concluded that potential adverse environmental effects to aquatic plants are mi nimal from pre-emergence use on soybean (USEPA 2008b). For terrestria l plants, there is a conc lusion of risk to all cat egories except non-listed monocots in adjace nt upland areas exposed to mesotrione in runoff. 41 Such potential risks are managed by adherence to the application requirem ents stated on EPA-approved herbicide labels.



### 6.2.2 Ecological Risks of Isoxaflutole

Isoxaflutole is registered by the EP A for use in a variety of crops, including limited use in soybean (USEPA 2012a). Pursuant to FIFRA Section 3(g), EPA is currently conducting registration review for isoxaflutole to ensure continuing fulfillme nt of FIFRA registration standards. The EPA registration review for isoxaflutole is schedul ed to be completed in 2017 (USEPA 2011a).

Isoxaflutole was conditionally regi stered on September 15, 1998; the conditional registration was extended on April 11, 2002 and the product was unconditionally registered on October 4, 2004 (USEPA 2011b). Isoxaflutole is currently registered as a Restricted Use Pesticide due to non-target phytotoxicity concerns. In contrast to General Use Pesticides, isoxaflutole must be applied by or under the supervision of a certified applicator. Th e results of multiple ec ological and human-health risk assessments are provided in the appended info rmation about isoxaflutole. In summary, risks to aquatic plants, birds, mammals, invertebrates a nd fish were below the EPA level of concern.

EPA opened Docket Number EPA-HQ-OPP-2010-097 9 on June 29, 2011 (U SEPA 2011c). Public comments on the Isoxaflutole Summary Document Re gistration Review: Initial Docket (USEPA 2011b) were received through August 2011, closing Phase 1. The registra tion review fo r isoxaflutole is now in Phase 2. EPA issued the final Regist ration Review Work Plan on November 28, 2011 (USEPA 2011a) and the generi c data call-in on October 26, 2012 (USEPA 2012b).



### 6.2.3 Ecological Risks of Glufosinate

Glufosinate is currently registered by the EPA for use in a variety of crops, including soybean (USEPA 2012a). Pursuant to FIFRA Section 3(g), EPA is currently conducting registration review for glufosinate to ensure continuing fulfillment of FIFRA registration standards. An updated human health risk assessment was published on July 25, 2012 (USEPA 2012c) and preliminary human health and environmental fate and ecologica l risk assessments were dated January 26, 2013 (USEPA 2013b); but released to the public on March 7, 2013. The results of these assessments are summarized in the glufosinate appendix. The p ublic comment period on these documents will close on May 6, 2013 (USEPA 2013a). Subm ittals to this analysis can be found at www.Regulations.gov under docket designation EPA-HQ-O PP-2008-0190. EPA ha s approved the continued use of this herbicide co nsistent with current label restri ctions pending the outcome of the ecological risk assessments being conducted as part of the registration review of glufosinate.

41 EPA notes that although the Section 3 New Use (proposed in 2009 for soybeans) application rate of 0.188 lb ai/A is the same as the lowest of currently registered uses, the environmental conditions under which soybeans are grown can lead to higher runoff and so to higher surface water EECs than other uses at this rate. The EECs from this application rate are still not high enough to lead to RQs that exceed the non-endangered level of concern for vascular plants.– 114 – This page intentionally left blank.– 115 – 

## 7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACTS

As required by the CEQ, this Chap ter considers the Executive Orders (EOs), standards, and treaties related to the potential en vironmental impacts of th e Preferred Alternative.



### 7.1 Executive Orders with Domestic Implications

Four EOs have domestic implications that are re levant to the environmental assessment of the petition to deregulat e SYHT0H2 soybean.



### 7.1.1 Executive Order 12898: Environmental Justice

EO 12898, Federal Actions to Address Environmenta l Justice in Minority Populations and Low-Income Populations 42 , requires federal agencies to co nduct their programs, policies, and activities that substantially affect human health or the environment in a manne r so as not to exclude persons and populations from partic ipation in or benefiting from su ch 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 Petitione rs. Data and information provide d by the Petitioners support the safe use of SYHT0H2 soybean a nd indicate that it will be as nut ritious and wholesome as other soybean currently used as food and feed. Ba sed on these analyses, SYHT0H2 soybean is not expected to have a disproportionate adverse ef fect on minorities or lo w-income populations.

As described in Chapter 4, Section 4.2.2, Agronomic Practices , the cultivation of previously deregulated soybean varieties 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 minor ity populations. Any effect would be negligible, assuming that the herbicides are used in acco rdance with label precautions. These populations might include farm workers and their families, and other rural dwelli ng individuals who are potentially exposed to herbicides through aerial application, groundwater, or other routes of
exposure.

42 EO 12898 of February 11, 1994; 59 FR 7629.– 116 – 

### 7.1.2 Executive Order 13045: Protection of Children

EO 13045, Protection of Children from Environm ental Health Risks and Safety Risks 43

, acknowledges that children may suff er disproportionately from e nvironmental health and safety risks because of their developmenta l 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 mi ssion) to identify, assess, and a ddress environmental health risks and safety risks that may disp roportionately 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 Petitione rs. Data and information provide d by the Petitioners support the safe use of SYHT0H2 soybean a nd indicate that it will be as nutritious and wholesome as other soybean currently used as food and feed. Ba sed on these analyses, SYHT0H2 soybean is not expected to have a disproportiona te adverse effect on children.

As described in Chapter 4, Section 4.2.2, Agronomic Practices , the cultivation of previously deregulated soybean varieties 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 childre n 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 po pulations, these children might in clude families of farm workers and other rural dwelling individuals who are expos ed to herbicide through aerial application, groundwater contamination, or other routes.



### 7.1.3 Executive Order 13112: Invasive Species

EO 13112, Invasive Species 44 , requires federal agencies to take action to prevent the introduction of invasive species, to provide for their contro l, 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 gran ted non-regulated status 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 spec ies. Accordingly, the Preferred Alternative would not raise concerns ad dressed by EO 13112, Invasive Species

.

43 EO 13045 of April 21, 1997; 62 FR 19885. 44 EO 13112 of February 3, 1999; 64 FR 6183.– 117 – 

### 7.1.4 Executive Order 13186: Migratory Birds

EO 13186, Responsibilities of Federal Agencies to Protect Migratory Birds 45 , 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 t oxicity hazard. Additionally, the Petitioners conducted a feeding study on broiler chickens , in which no harmful effects were observed. Granting non-regulated status to this soybean cultiv ar therefore is not expected to have a negative effect on migratory bird populations. The Preferre d Alternative would be in compliance with EO 13186, Responsibilities of Federal Agencies to Protect Migratory Birds

.



### 7.2 Executive Orders with Int ernational Implications

EO 12114, Environmental Effects Abr oad of Major Federal Actions 46 , requires federal officials to take into consideration any pote ntial environmental effects outsi de the US, its territories, and possessions that may result from actions being taken.

All of the existing nation al and internationa l regulatory authorities and phytosanitary regimes that currently apply to introduction of new soybean cultivars in ternationally apply equally to those covered by an APHIS determinatio n of non-regulated status under 7 CFR part 34 0. International trade of SYHT0H2 soybean subseque nt to a determination of non-re gulated status for the product would be fully subject to nati onal phytosanitary requirements and be in accordance with phytosanitary standards developed under the International Plant Pr otection Convention (IPPC 1997).

The purpose of the IPPC “is to secure a common and effective act ion 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 natu ral flora and plant products and includes both direct and indirect damage by pests, including weeds. Th e IPPC set a standard for the reciprocal acceptance of phytosanitary certification am ong the 177 nations that have sign ed or acceded to the convention 47 . In April 2004, a standard for pest risk analysis (PRA) of living modifi ed 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 gene tic modification. APHIS pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed under the IPPC. In addi tion, 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.

45 EO 13186 of January 10, 2001; 66 FR 3853. 46 EO 12114 of January 4, 1979; 44 FR 1957. 47 https://www.ippc.int/– 118 – The Cartagena Protocol on Biosafety (the Protocol) (SCBD 2000) is a treaty un der the United Nations Convention on Biol ogical Diversity (CBD) that established a framework for the safe transboundary movement, with re spect to the enviro nment and biodiversi ty, of LMOs, which includes those modified through biotechnology. The Protocol cam e into force on September 11, 2003, and 193 countr ies are currentl y parties to it 48 . 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 tran sboundary movement of LMOs intended fo r environmental release (field trials or commercia l planting) will require consent from the importing co untry 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 exem pt from the AIA proce dure, and are covered under Article 11 and Annex II of the Protocol. Unde r Article 11, parties must post decisions to the Biosafety Clearinghouse database on domesti c use of LMOs for FFP that may be subject to transboundary movement. To facilit ate compliance with obligations to this protoc ol, the US gov ernment has developed a website 49 that provides the status of all regulatory reviews completed for different uses of bioengineered products

. These data will be ava ilable to the Biosafety Clearinghouse. International trade of SYHT0H2 soyb ean would be conducted in co mpliance with the Protocol.

Biosafety and biotechnology consensus documents, guidelines, and regulations, are managed by APHIS in accordance with the requirements of th e North American Plant Protection Organization (NAPPO) and the Organization for Economic Cooperation and Development (OECD). The Preferred Alternative is not expe cted to affect APHIS’s partic ipation 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 regul arly 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 s oybean export market since the Petitioners are actively pursuing regulatory approvals for SYHT0H2 soybean in count ries with functioning regulatory systems for genetically modified organisms and that import s oybean from the US or Canada. Regulatory filings for SYHT0H2 soybean import approvals have been ma de in Canada, Argentina, Japan, Republic of China, South Korea, Australia and New Zealand, th e 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

48 http://www.cbd.int/conv ention/parties/list/ 49 http://usbiotechreg.nbii.gov– 119 – to deregulate SYHT0H2 soybean. Other federal land management laws and regulations address the unique characteristics of certain geographic areas, and are also potentially relevant to deregulation of SYHT0H2 soybean.



### 7.3.1 Clean Water Act

The Federal Water Pollution Control Act 50 (commonly referred to as the Clean Water Act) and implementing regulations 51 require entities that discharge regu lated materials to certain surface water bodies (including wetlands) obtain authoriza tion 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. Deregulating SYHT0H2 soybean would not result in a change of agricultural practices or any new disc harge of pollutants to surface water bodies. Water quality would continue to be regulated and agronomic practices to protect wa ter quality would continue to be implemented if SYHT0H2 soybean is de regulated. Cultivating SYHT0H2 soybean would not require Clean Water Act permits different than t hose already required for agricultural activities.



### 7.3.2 Clean Air Act

The Clean Air Act Amendments of 1990 52 (commonly referred to as the Clean Air Act) and implementing regulations 53 require entities that discharge regulat ed 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 no t 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 conti nue current trends in agricultural activities if SYHT0H2 soybean is deregulated. Cultivating S YHT0H2 soybean would not require Clean Air Act permits different than those alrea dy required for agricultural activities.



### 7.3.3 National Historic Preservation Act

The National Historic Preservation Act 54 (NHPA) and its implementing regulations 55 require federal agencies to:

Determine whether activities they propose const itute "undertakings" that have the potential to cause effects on historic properties, and

50 33 USC Sections 1251-1376 51 33 CFR parts 320-332 and 40 CFR parts 230-233 52 40 USC 7401-7671 53 40 CFR parts 50-99 54 16 USC Section 470 et seq. 55 36 CFR parts 800-801– 120 – If so, to evaluate the effects of such undertak ings on such historic re sources 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 take n 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 Prefe rred 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 whic h 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 al one or in approved stacks is not expected to change any of these agronomic practices that would resu lt in an adverse impact under the NHPA.



### 7.3.4 Federal Laws Regarding Unique Characteristics of Geographic Areas

Other federal land management laws and regula tions 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 a ny 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. Th e Preferred Alternative is limited to a determination of non-regulated status of SYHT0H2 soybean. This ac tion would not convert agricultural land use to nonagricultural use and therefore would have no adverse impact on prime farm land. Standard agricultural practices for la nd preparation, planting, pest control, irrigation, and harvesting of plants would be used on agri cultural lands planted to SYHT0H2 soybean, alone or when stacked with other deregulated soybean traits.– 121 – 

## 8 LIST OF PREPARERS

Vanasse Hangen Brustlin, Inc.

Jonathan Feinstein Senior Vice President Senior Technical Advisor M. Community Planning and Area Development, University of Rhode Island B.S., Natural Resources Development, University of Rhode Island
Over 30 years of experience in environmental consulting and prepar ing NEPA documents

Dr. Lisa A. Standley Chief Environmental Scientist Technical Document Lead Ph.D., Botany, University of Washington M.S., Botany, Cornell University B.S., Ecology and Systematics, Cornell University
26 years of experience in environmental consulting and 21 years of experience in preparing NEPA documents

Christopher Rife Senior Project Manager Lead Document Author M. Environmental Policy and Management, University of Denver B.A., Philosophy Humboldt State University
21 years of experience in environmental consulting and 16 years of experience in preparing NEPA documents

Rhodes Life Sciences, LLC

Dr. Richard C. Rhodes III President and Associate Director Rhode Island Agricultural Experiment Station and Rhode Island Cooperative Extension Associate Dean, College of the Environment and Life Sciences Ph.D., Physiology, Texas A&M University M.S., Physiology, Texas A&M University B.S., Agriculture, Univ ersity of Delaware
Over 30 years of research experience in endocrinology, physiology and agriculture– 122 – Syngenta Biotechnology

Demetra Vlachos Global Crop Lead - Soybean, Seeds Regulatory Affairs M.S., Genetics, Rutgers University B.A., Biological Sciences, Douglass College
21 years of experience in agricultural biotechnology regulatory affairs and environmental safety assessment of trans g enic crops

Dr. Dennis War d US Lead, Seeds Regulatory Ph.D., Pharmacology and Toxicology, University of California

B.S., Biochemistry, Univ ersity of Californi a 26 years of experience in toxicology, risk assessment and regulatory affairs within the agricultural technology industry

Dr. Lawrence Zeph Head, North American Seeds Regulatory Ph.D., Molecular and Cell Biology, Pennsylvania State University B.A., Biolo gy , Indiana Universit y 23 years of experience in regulatory policy for transgenic crops

Bayer CropScience AG

Russell Essner Global Regulatory Affairs Manager B.S., Biology, University of Minnesota M.S., Environmental Science, Bemidji State University 14 years of experience in agricultural biotechnology, regulatory affairs and safety assessment of transgenic crops
Michael Weeks US Registration Manager B.S., Agronomy,. North Carolina State University M.S., Crop and Environmen tal Sciences, Virginia Tech (VPI and SU) 5 years of experience in agronomic research and regulatory affairs in the agricultural biotechnology industr y Russell L. Jones Fellow, Environmental Safety Ph.D., Chemical Engineering, University of California, Berkley B.S. and M.S., Chemical Engineering, Massachusetts Institute of Technology 37 years of experience in modeling, field research, and risk assessment– 123 – Bayer CropScience AG (Continued)
Dr. Tilghman Hall Research and Development Fellow Ph.D., Zoology, Miami University M.En., Environmental Scie nce, Miami University B.S., Biology, Eckerd College 19 years of experience in environmental toxicology and risk assessment

Dr. Michael Dobbs Senior Principal Scientist Ph.D., Biology, Virginia Tech M.S., Environmental Health Science, University of Michigan, Ann Arbor B.S., Environmental Science, University of Massachusetts, Amherst– 124 – This page intentionally left blank.– 125 – 

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# Appendix A: Mesotrione Description, Uses, and Potential Impacts

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# Appendix B: Isoxaflutole Description, Uses, and Potential Impacts

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# Appendix C: Glufosinate Description, Uses, and Potential Impacts