Dow AgroSciences Petition for Determination of 

Nonregulated Status of Herbicide-and Insect-Resistant 

DAS-81419-2 Soybean (12-272-01p)

OECD Unique Identifier: DAS-81419-2

Environmental Assessment 

February 2014

Agency Contact

Cindy Eck

USDA, APHIS, BRS 

4700 River Road, Unit 91 

Riverdale, MD 20737-1237 

Phone: (301) 851-3892

Fax: (301) 734-8910 

Cynthia.A.Eck@aphis.usda.gov

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and/or Federal agencies before they can be recommended. 

Page 1 of 101
Table of Contents

1 PURPOSE AND NEED .......................................................................................................... 6

1.1 Background ...................................................................................................................... 6

1.2 Purpose of Product ........................................................................................................... 6

1.3 Coordinated Framework Review and Regulatory Review............................................... 7

1.3.1 USDA-APHIS........................................................................................................... 8

1.3.2 Environmental Protection Agency............................................................................ 8

1.3.3 Food and Drug Administration ................................................................................. 9

1.4 Purpose and Need for USDA-APHIS Action .................................................................. 9

1.5 Public Involvement ........................................................................................................ 10

1.5.1 First Opportunity for Public Involvement............................................................... 10

1.5.2 Second Opportunity for Public Involvement. ......................................................... 10

1.6 Issues Considered........................................................................................................... 12

1.7 Relevant Regulatory Background and Safety Assessments........................................... 13

1.8 Action............................................................................................................................. 14

1.9 Action Area .................................................................................................................... 15

2 ALTERNATIVES ................................................................................................................. 15

2.1 No Action Alternative: Continuation as a Regulated Article......................................... 15

2.2 Preferred Alternative: Determination that DAS-81419-2 Soybean Is No Longer a 

Regulated Article....................................................................................................................... 15

2.3 Alternatives Considered, Not Included in Detailed Analysis ........................................ 16

2.3.1 Prohibit Any DAS-81419-2 from Being Released ................................................. 16

2.3.2 Approve the Petition in Part.................................................................................... 17

2.3.3 Isolation Distance between DAS-81419-2 Soybean and Non-GE Soybean 

Production and Geographical Restrictions............................................................................ 17

2.3.4 Requirement of Testing for DAS-81419-2 Soybean .............................................. 17

2.4 Comparison of Alternatives ........................................................................................... 18

3 AFFECTED ENVIRONMENT............................................................................................. 21

3.1 Soybean Agricultural Production and Practices............................................................. 21

3.1.1 Areas and Acreage of Soybean Production ............................................................ 21

3.1.2 Land Use ................................................................................................................. 22

3.1.3 Agronomic Practices............................................................................................... 24

3.2 Soybean Seed Production............................................................................................... 32

3.3 Organic Soybean Production.......................................................................................... 34

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3.3.1 Organic Practices.................................................................................................... 34

3.3.2 Weed, Pest, and Disease Control in Organic Agriculture....................................... 34

3.3.3 Economic/Market Data for Organic Agriculture .................................................... 35

3.4 Physical Environment .................................................................................................... 36

3.5 Biological Resources...................................................................................................... 36

3.5.1 Animal Communities.............................................................................................. 36

3.5.2 Plant Communities.................................................................................................. 38

3.5.3 Gene Flow and Weediness...................................................................................... 38

3.5.4 Microorganisms ...................................................................................................... 38

3.5.5 Biodiversity............................................................................................................. 39

3.6 Human Health ................................................................................................................ 39

3.6.1 FDA Review ........................................................................................................... 39

3.6.2 EPA Review............................................................................................................ 39

3.7 Animal Feed ................................................................................................................... 40

3.8 Socioeconomics.............................................................................................................. 40

3.6.1 Domestic Economic Environment .......................................................................... 40

3.6.2 Trade Economic Environment ................................................................................ 41

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

4.1 Scope of Analysis........................................................................................................... 42

4.1.1 Herbicide use .......................................................................................................... 42

4.1.2 Stacking................................................................................................................... 42

4.2 Agricultural Production of Soybean............................................................................... 43

4.2.1 Acreage and Area of Soybean Production.............................................................. 43

4.2.2 Agronomic Practices............................................................................................... 43

4.2.3 Soybean Seed Production ....................................................................................... 45

4.2.4 Organic Soybean Production .................................................................................. 46

4.3 Physical Environment .................................................................................................... 47

4.3.1 Soil Quality............................................................................................................. 47

4.3.2 Water Resources ..................................................................................................... 49

4.3.3 Air Quality .............................................................................................................. 50

4.3.4 Climate Change....................................................................................................... 50

4.4 Biological Resources...................................................................................................... 51

4.4.1 Animal Communities.............................................................................................. 51

4.4.2 Plant Communities.................................................................................................. 54

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4.4.3 Gene Flow and Weediness...................................................................................... 55

4.4.4 Microorganisms ...................................................................................................... 56

4.4.5 Biodiversity............................................................................................................. 58

4.5 Human Health ................................................................................................................ 59

4.6 Animal Feed ................................................................................................................... 61

4.7 Socioeconomic Impacts.................................................................................................. 62

4.7.1 Domestic Economic Environment .......................................................................... 62

4.7.2 Trade Economic Environment ................................................................................ 63

5 CUMULATIVE IMPACTS .................................................................................................. 65

5.1 Assumptions Used for Cumulative Impacts Analysis.................................................... 65

5.2 Cumulative Impacts: Acreage and Area of Soybean Production................................... 65

5.3 Cumulative Impacts: Agronomic Practices.................................................................... 66

5.4 Cumulative Impacts: Soybean Seed Production ............................................................ 68

5.5 Cumulative Impacts: Organic Soybean Production ....................................................... 69

5.6 Cumulative Impacts: Water Resources.......................................................................... 69

5.7 Cumulative Impacts: Soil Quality.................................................................................. 70

5.8 Cumulative Impacts: Air Quality ................................................................................... 71

5.9 Cumulative Impacts: Climate Change............................................................................ 71

5.10 Cumulative Impacts: Animal Communities................................................................... 71

5.11 Cumulative Impacts: Plant Communities....................................................................... 73

5.12 Cumulative Impacts: Gene Flow and Weediness........................................................... 73

5.13 Cumulative Impacts: Microorganisms........................................................................... 73

5.14 Cumulative Impacts: Biodiversity.................................................................................. 74

5.15 Cumulative Impacts: Human Health.............................................................................. 75

5.16 Cumulative Impacts: Animal Feed................................................................................. 76

5.17 Cumulative Impacts: Domestic Economic Environment............................................... 76

5.18 Cumulative Impacts: Trade Economic Environment..................................................... 77

6 THREATENED AND ENDANGERED SPECIES .............................................................. 78

6.1 Scope of Analysis........................................................................................................... 78

6.2 Potential Effects of DAS-81419-2 Soybean on TES and Critical Habitat ............... 80

6.2.1 Threatened and Endangered Plant Species and Critical Habitat............................. 80

7 Appendix A. Relative Costs of Herbicides for Application ............................................... 101

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List of Tables.

Table 1. Summary of issues of potential impacts and consequences of alternatives.................... 18

Table 2. U.S. soybean production, 2012 and 2013. ...................................................................... 22

Table 3. U.S. certified organic soybean acres by state, 2008. ...................................................... 36

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1 PURPOSE AND NEED

1.1 Background

Dow AgroSciences (hereinafter “DAS”) of Indianapolis, IN has submitted a petition, APHIS 

Number12-272-01p, to the United States Department of Agriculture (USDA) Animal and Plant 

Health Inspection Service (APHIS) in November 2012. The purpose of the petition is to support 

a decision of nonregulated status for DAS-81419-2 soybean (referred hereafter as DAS-81419-2

soybean) which is resistant1 to the herbicide glufosinate and resistant to lepidopteran insects.

The event DAS-81419-2 soybean is currently regulated under 7CFR part 340. Interstate 

movements and field trials of event DAS-81419-2 soybean have been conducted under permits

issued or notifications acknowledged by APHIS since 2009. These field trials were conducted 

within thirteen US states and Puerto Rico. Data resulting from these field trials are described in 

the petition (Dow AgroSciences, 2012) and analyzed for plant pest risk in the USDA-APHIS 

Plant Pest Risk Assessment (PPRA) (USDA-APHIS, 2012).

The petition stated that APHIS should not regulate DAS-81419-2 soybean because it does not 

present a plant pest risk. If a determination of nonregulated status is made, it would include 

DAS-81419-2 soybean, any progeny derived from crosses between DAS-81419 soybean and 

conventional soybean, and crosses of DAS-81419-2 soybean with other biotechnology-derived 

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

Regulations) Part 340 under the authority of the Plant Protection Act of 2000 (PPA). 

1.2 Purpose of Product

A pat gene, from the bacterium Streptomyces viridochromogenes was transformed into soybean 

for resistance to the herbicide glufosinate. The protein expressed by the gene, phosphinothricin 

acetyltransferase (PAT) protein, confers resistance to the common herbicide glufosinate

ammonium. Two other genes cryF, originally from Bacillus thuringiensis subsp. aizawa strain 

PS811and cry1Ac from B. thuringiensis subsp. kurstaki strain HD73 were also transformed into 

soybean for resistance to several lepidopteran pests of soybean, including the velvetbean 

caterpillar, Anticarsia gemmatalis and others. DAS has developed DAS-81419-2 soybean to 

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

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

lethal to the wild type HRAC, "Guideline to the Management of Herbicide Resistance," (2013), 

<http://www.hracglobal.com/Overview/ManagementofResistance.aspx>.. Several technologies are available that 

can be used to develop herbicide resistance in plants including classical breeding, tissue culture, mutagenesis and 

genetic engineering. “Tolerance” is distinguished from resistance and defined by HRAC (2013) as the inherent 

ability of a plant to survive and reproduce following exposure to an herbicide treatment. This implies the 

circumstance in which there is no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant. 

Throughout this EA (Environmental Assessment), APHIS has used the terms “resistance” and “tolerance” consistent 

with the definitions of the HRAC. It should be noted however, that different terms for the same concept may be used 

interchangeably in some instances. In its petition to USDA APHIS Dow AgroSciences referenced the subject as, 

“glufosinate-tolerant soybean,” and used the term “herbicide tolerant” throughout its documentation to describe it 

(Dow AgroSciences, 2012). This terminology can be considered synonymous with “herbicide-resistant” (HR) used 

in this EA.

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protect the plants from leaf-feeding damage by the larval stages of specific lepidopteran insects. 

In addition DAS-81419-2 will make available an additional variety of glufosinate resistant 

soybean to growers and seed suppliers for weed management. DAS-81419-2 soybean was 

developed for South America, where lepidopteran pest pressure exceeds economic thresholds. 

Soybean grown in regions of the U.S. (mainly the southeast) can experience economic damage 

by lepidopteran soybean pests; thus future use of DAS-81419-2 soybean may include U.S. 

commercialization under appropriate regulatory authorizations. To supply soybean seed for the 

South American market, DAS has obtained a breeding and seed increase registration with the 

EPA under FIFRA Section 3. 

Availability of DAS-81419-2 soybean could reduce the need for insect scouting, preserve 

beneficial insect populations, as well as provide increased efficiency for soybean insect 

protection. Cry1Ac and Cry1F have been shown to bind to different receptors in the midgut of 

the target soybean insect pest tobacco budworm (H. virescens) (Jurat-Fuentes and Adang, 2001): 

Cry1Ac binds to at least three sets of receptors while Cry1F binds to at least two, only one of 

which also binds Cry1Ac. The major receptor in the insect gut for Cry1Ac does not bind Cry1F 

(Jurat-Fuentes and Adang, 2006). Bt gene pyramiding offered by DAS-81419-2 soybean offers

potentially greater durability than Bt crops carrying a single Bt trait and provides deterrence to

the development of insect resistance.

The PAT protein provides resistance to the herbicide glufosinate ammonium and was used as a 

selectable marker during product characterization and development. Glufosinate resistance 

allows growers to employ this ‘over-the-top’ broad spectrum herbicide that can control 

glyphosate resistant weeds. DAS has plans to cross DAS-81419-2 soybean with other 

deregulated herbicide resistant soybean varieties, such as those expressing glyphosate resistance. 

1.3 Coordinated Framework Review and Regulatory Review

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

pursuant to Federal regulations published in the Federal Register (EOP-OSTP; US-FDA)

entitled The Coordinated Framework for the Regulation of Biotechnology (henceforth referred to 

here as the Coordinated Framework). The Coordinated Framework, published by the Office of 

Science and Technology Policy, describes the comprehensive federal regulatory policy for 

ensuring the safety of biotechnology research and products and explains how federal agencies 

will use existing Federal statutes in a manner to ensure public health and environmental safety 

while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology 

industry. The Coordinated Framework is based on several important guiding principles: (1) 

agencies should define those transgenic organisms subject to review to the extent permitted by 

their respective statutory authorities; (2) agencies are required to focus on the characteristics and 

risks of the biotechnology product, not the process by which it is created; (3) agencies are 

mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” 

risk.

The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA APHIS, the Environmental Protection 

Agency (EPA), and the Food and Drug Administration (FDA). A summary of each role follows:

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1.3.1 USDA-APHIS

APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority granted by 

the PPA, as amended (7 United States Code (U.S.C.) 7701–7772), regulate the introduction (i.e., 

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

products. A GE organism is no longer subject to the plant pest provisions of the PPA or to the 

regulatory requirements of 7 CFR part 340, when APHIS determines that it is unlikely to pose a 

plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient 

organism, vector, or vector agent used in engineering the organism belongs to one of the taxa 

listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also 

regulated under 7 CFR 340, when APHIS has reason to believe that the GE organism may be a 

plant pest or APHIS does not have information to determine if the GE organism is unlikely to 

pose a plant pest risk. 

A person may petition the agency for a determination that a particular regulated article is 

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

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

provide information related to plant pest risk that the agency can use to determine whether the 

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

GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1.3.2 Environmental Protection Agency

The EPA is responsible for regulating the sale, distribution, and use of pesticides, including 

pesticides that are produced by an organism through techniques of modern biotechnology. The 

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

Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.) and certain biological control organisms under 

the Toxic Substances Control Act (TSCA) (15 U.S.C. 53 et seq.). Before planting a crop 

containing a PIP, a company must seek an experimental use permit from EPA. Commercial 

production of crops containing PIPs for purposes of seed increases and sale requires a FIFRA 

Section 3 registration with EPA. 

Under FIFRA (7 U.S.C. 136 et seq.), EPA regulates the use of pesticides, and requires 

registration of all pesticide products for all specific uses prior to distribution for sale. EPA 

examines: the ingredients of the pesticide; the particular site or crop on which it is to be used; the 

amount, frequency, and timing of its use; storage and disposal practices. Prior to registration for 

a new use for a new or previously registered pesticide, EPA must determine through testing that 

the pesticide does not cause unreasonable adverse effects on humans, the environment, and nontarget species when used in accordance with label instructions. EPA must also approve the 

language used on the pesticide label in accordance with 40 CFR part 158. Once registered, a 

pesticide may only be legally used in accordance with directions and restrictions on its label. 

The overall intent of the label is to provide clear directions for effective product performance, 

while minimizing risks to human health and the environment. The Food Quality Protection Act 

(FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of 

pesticides to ensure they are meeting current scientific and regulatory standards of safety and 

continue to have no unreasonable adverse effects (US-EPA, 2011). 

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

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

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

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

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

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

1.3.3 Food and Drug Administration

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

FDA published its policy statement concerning regulation of products derived from new plant 

varieties, including those derived from genetic engineering, on May 29, 1992 (US-FDA). Under 

this policy, FDA implements a voluntary consultation process to ensure that human food and 

animal feed safety issues or other regulatory issues, such as labeling, are resolved before 

commercial distribution of bioengineered food. This voluntary consultation process provides a 

way for developers to receive assistance from FDA in complying with their obligations under 

Federal food safety laws prior to marketing.

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

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

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

voluntary food safety evaluations for new non-pesticidal proteins produced by new plant 

varieties intended to be used as food, including bioengineered plants. Early food safety 

evaluations help make sure that potential food safety issues related to a new protein in a new 

plant variety are addressed early in development. These evaluations are not intended as a 

replacement for a biotechnology consultation with FDA, but the information may be used later in 

the biotechnology consultation.

1.4 Purpose and Need for USDA-APHIS Action

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

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

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

GE organisms, including GE plants such as DAS-81419-2 Soybean. When a petition for 

nonregulated status is submitted, APHIS must determine if the GE organism is unlikely to pose a 

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

plant pest risk that the agency may use to determine whether the regulated article is unlikely to 

present a greater plant pest risk than the unmodified organism. A GE organism is no longer 

subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA 

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

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

nonregulated status for DAS-81419-2 Soybean. USDA-APHIS has prepared this Environmental 

Assessment (EA) to consider the potential environmental effects of an agency determination of 

nonregulated status consistent with Council of Environmental Quality’s (CEQ) National 

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

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

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

of the human environment

2 that may result from a determination of nonregulated status for DAS81419-2 Soybean.

1.5 Public Involvement

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

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

notice published in the Federal Register. On March 6, 2012, APHIS published a notice3 in the

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

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

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

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

prepares an EA. The first notice will announce the availability of the petition, and the second 

notice will announce the availability of APHIS’ decision making documents. As part of the new 

process, with each of the two notices published in the Federal Register, there will be an 

opportunity for public involvement:

1.5.1 First Opportunity for Public Involvement

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

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

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

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

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

public comment will be announced in a Federal Register notice.

1.5.2 Second Opportunity for Public Involvement.

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

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

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

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

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

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

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

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

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

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

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

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

3

 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-5364.pdf

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

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

day public review period.

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

APHIS altering its preliminary regulatory determination or FONSI, substantially changing the 

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

EA, APHIS' preliminary regulatory determination becomes final and effective upon public 

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

published announcing the final regulatory determination.

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

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

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

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

been determined by APHIS to have nonregulated status or when APHIS determines that gene 

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

by APHIS. Substantive issues are identified by APHIS based on our review of the petition and 

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

period on the petition. 

APHIS solicits comments on its draft EA and draft PPRA for 30 days through the publication of 

a Federal Register notice. APHIS reviews and evaluates comments and other relevant 

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

of these documents, APHIS approves or denies the petition, announcing in the Federal Register

the regulatory status of the GE organism and the availability of APHIS' final EA, PPRA, 

National Environmental Policy (NEPA) decision document (either a FONSI or NOI to prepare 

an EIS), and regulatory determination. Enhancements to public input are described in more 

detail in the Federal Register notice4

published on March 6, 2012.

USDA-APHIS has decided this EA will follow Approach 1 because this is another EA prepared 

for soybean genetically engineered for resistance to glufosinate herbicides with the same pat 

gene as several other soybean varieties, and also for resistance to lepidopterous insects with the 

same Cry protein-expressing genes as many other soybean, cotton, and corn varieties. The DAS

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

April 29, 2013. As of that date, the docket file contained a total of 5 public submissions. One of 

the submissions to the docket contained multiple attached identical comments gathered by 

organizations from their members. Contained within the 5 submissions were a total of 561

identical public comments. Some of the comments expressed a general dislike of the use of GE 

organisms, health concerns for food or feed consumption or concerns for use of additional 

herbicides; some were form letters sent to all of the dockets which were open at the time that this 

docket was open. The form letter expressed a concern that there were too many dockets 

published on the same day. It also referenced other open dockets and potential effects from the 

use of the subjects of those petitions. These issues are outside the scope of this EA. The 

4 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-5364.pdf

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comments also encouraged a thorough review of all herbicide resistant crops, in the context of 

the potential for development of weed resistance to herbicides. Some comments were concerned 

about the development of insects resistant to the Cry proteins expressed by the variety, or 

concerned about admixture of GE soybean with organic soybean and admixture of GE lines with 

exported commodity soybean.

Issues raised in these public comments on the petition were focused on the nature of agronomic 

inputs associated with this new trait, potential impacts to plants from off-target drift, 

management of herbicide-resistant weeds, human health considerations from exposure to 

herbicides, and domestic and international economic impacts associated with the development 

and marketing of a new herbicide-resistant product. APHIS evaluated these raised issues and the 

submitted documentation. APHIS has also included a discussion of these issues in this EA.

1.6 Issues Considered

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

experience in considering public concerns and issues raised in public comments submitted for 

this petition and other EAs of GE organisms. The resource areas considered also address 

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

various stakeholders for this petition and in the past. The resource areas considered in this EA 

can be categorized as follows: 

Agricultural Production Considerations:

• Acreage and Areas of Soybean Production

• Soybean Seed Production

• Organic Soybean Production

Environmental Considerations

• Soil Quality

• Water Resources

• Air Quality 

• Climate Change

• Animal Communities

• Plant Communities

• Soil Microorganisms

• Biological Diversity

Public Health Considerations

• Human Health

• Worker Safety

Livestock Health Considerations

• Animal Feed/Livestock Health

Socioeconomic Considerations

• Domestic Economics

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• Trade Economics 

1.7 Relevant Regulatory Background and Safety Assessments

USDA Review of Cry and PAT proteins

Cry proteins are highly specific, derived from a naturally occurring soil bacterium, Bacillus 

thuringiensis (Bt). Crops genetically engineered to produce Cry proteins have been widely 

adopted; Bt cotton now represents 75% of the cotton planted in the U.S and Bt corn is about 67% 

of the corn acreage (USDA-NASS 2012). The Cry1F and Cry1Ac proteins expressed in DAS81419-2 soybean are the same as those present in the previously deregulated WideStrike cotton 

events DAS-21023-5 and DAS-24236-5 (USDA-APHIS, 2004). 

Other genetically engineered (GE) crops containing Cry technology include Monsanto’s GE 

soybean, producing Cry1Ac (MON 87701), which was deregulated by APHIS in 2011 (USDAAPHIS, 2011b), and Monsanto’s Bollgard® Cotton (Event 531), also producing Cry1Ac, which 

was deregulated by APHIS in 1995 (USDA-APHIS, 1995). 

The PAT protein is encoded by the pat gene isolated from the soil bacterium S. 

viridochromogenes and inactivates the herbicide glufosinate ammonium. The pat gene has been 

widely used both as a selectable marker and an herbicide resistance trait in previously 

deregulated crops (USDA-APHIS, 1996; USDA-APHIS, 2001; USDA-APHIS, 2004; USDAAPHIS, 2005). Although there are commercial varieties of GE soybean with resistance to 

glufosinate ammonium available in the US, DAS-81419-2 soybean would be the first soybean 

product producing the Cry1Ac, Cry1F, and PAT proteins. 

EPA Review of Cry and PAT Proteins

Substances that are pesticides, as defined under the Federal Insecticide, Fungicide and 

Rodenticide Act (FIFRA) [7 U.S.C. §136(u)], are subject to regulation by the Environmental 

Protection Agency (EPA). Plant-incorporated protectants (PIPs), are also subject to regulation 

by the EPA under FIFRA. 

Cry1Ac has an existing exemption from the requirement of a tolerance in all food and feed 

commodities granted by EPA in 1997 and published in the Code of Federal Regulations at 40 

CFR §174.510 Cry1F has an exemption from tolerance for cotton and corn at 40 CFR §174.504

and 40 CFR §174.520, respectively (EPA, 2012a). Bt corn and Bt cotton expressing variations 

of Cry1Ac or Cry1F have been cultivated for commercial use in the U.S. and other countries for 

more than a decade. Exemptions from tolerance have been established based on safety 

assessments demonstrating a lack of allergenicity and toxicity to mammals. DAS has petitioned 

the U.S. EPA for an exemption from tolerance for Cry1F in soybean as a component of the 

application for registration for DAS-81419-2 Soybean. 

Since the PAT protein has been included as an herbicide resistance marker in products 

containing PIPs, it has been reviewed by EPA as a PIP inert ingredient (EPA, 2005a). Based on 

 WideStrike is a registered trademark of Dow AgroSciences LLC. ® Bollgard is a registered trademark of Monsanto Technology LLC.

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its environmental risk assessment, the EPA determined that the PAT protein presents a low 

probability of risk to human health and the environment and granted an exemption from the 

requirement of a tolerance for this PIP inert ingredient (EPA, 1997; EPA, 2007b; EPA, 2012c). 

DAS submitted an application for a FIFRA Section 3 seed increase registration of DAS-81419-2 

soybean on July 27th, 2012. Under a seed increase registration, commercial sale of DAS-81419-

2 soybean in the U.S. is prohibited by law. Should DAS decide to commercialize DAS-81419-2 

soybean in the U.S., DAS will apply for an EPA FIFRA Section 3 registration for commercial 

use. The terms of EPA’s Section 3 commercial use registrations for PIPs require the registrant to

develop, administer and oversee an insect resistance management (IRM) program approved by 

the EPA. 

EPA Review of Glufosinate Ammonium

Glufosinate ammonium was first registered by EPA for use in crops in 2000 as a non-selective 

foliar herbicide used for pre-plant and post-emergence control of broadleaf weeds (EPA, 2008b). 

It is currently registered for use on soybeans and other crops including apples, berries, canola, 

corn, cotton, currants, grapes, grass grown for seed, potatoes, rice, sugar beets, and tree nuts and 

for use in non-crop areas including lawns and residential areas (EPA, 2008b). 

FDA Review of Cry and PAT Proteins

The FDA previously reviewed data on the Cry1Ac and Cry1F proteins as present in DAS-21023-

5 and DAS-24236-5 (FDA, 2004a; FDA, 2004b). The FDA assessed the safety and nutritional 

data provided by DAS with regards to the use of the cotton in food and feed and concluded that it

has no further questions (FDA, 2004a; FDA, 2004b). A biotechnology consultation on the PAT 

protein was conducted in 1998 and does not require additional evaluation by the FDA (FDA, 

1998b). 

DAS initiated the consultation process with FDA for DAS-81419-2 soybean and submitted a 

Biotechnology Notification File (BNF 00140) for safety and nutritional assessment of food and 

feed derived from DAS-81419-2 to the FDA on September 26, 2012.

Global Assessment of Cry proteins

The food and feed safety of Cry proteins has been assessed by regulatory agencies worldwide, 

and Bt crops have been adopted in numerous countries (Betz et al., 2000). For example, 

WideStrike® cotton (DAS-21023-5; DAS-24236-5, expressing the same Cry1Ac and Cry1F 

proteins as DAS-81419-2 soybean) has received regulatory approval in Canada (import), 

Australia (food, feed), Brazil (cultivation, food, feed), Japan (import, food, feed), Mexico (food,

feed); EU (food, feed) and Korea (food, feed) (Biotechnology Industry Organization, 2012). 

1.8 Action

DAS requests determination of non-regulated status for DAS-81419-2 soybean, any progeny 

derived from crosses between DAS-81419-2 soybean and conventional soybean, and any 

progeny derived from crosses of DAS-81419-2 soybean with other biotechnology-derived 

soybean that has been granted non-regulated status under 7 CFR Part 340.

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1.9 Action Area

Under the proposed EPA Section 3 seed increase registration, planting of DAS-81419-2 soybean

will be on limited acreage throughout the U.S., with activity to support South American 

commercial soybean production market. If future application to EPA is made for commercial 

production/registration in the U.S., all areas of U.S. soybean cultivation will be considered, with 

highest adoption expected in areas experiencing economically significant insect pest pressure. 

This currently includes regions in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, 

Mississippi, Missouri, North Carolina, South Carolina, Tennessee, Texas, and Virginia (Musser 

et al., 2010; USDA-APHIS, 2011b; Musser et al., 2012).

2 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of DAS-81419-2 soybean. To respond favorably to a petition for 

nonregulated status, APHIS must determine that DAS-81419-2 is unlikely to pose a plant pest 

risk. Therefore APHIS must determine that DAS-81419-2 is no longer subject to 7 CFR part 340 

or the plant pest provisions of the Plant Protection Act. Based on its PPRA (USDA-APHIS, 

2012), USDA-APHIS has concluded that DAS-81419-2 soybean is unlikely to pose a plant pest 

risk. Therefore, USDA-APHIS must determine that DAS-81419-2 soybean is no longer subject 

to 7 CFR Part 340 or the plant pest provisions of the PPA. 

Two alternatives are evaluated in this Environmental Assessment: (1) no action and (2) 

determination of nonregulated status of DAS-81419-2 (preferred alternative). USDA-APHIS has 

assessed the potential for environmental impacts for each alternative in the Environmental 

Consequences section. Other alternative actions were considered but not included in the detailed 

analysis (see Section 3.3). 

2.1 No Action Alternative: Continuation as a Regulated Article 

Under the No Action Alternative, APHIS would deny the petition. DAS-81419-2 soybeans and 

progeny derived from DAS-81419-2 soybeans would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions of DAS-81419-2 soybeans and measures to ensure physical and 

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

alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation of DAS-81419-2 soybean. 

This alternative is not the preferred alternative because APHIS has concluded through a Plant 

Pest Risk Assessment that DAS-81419-2 soybean is unlikely to pose a plant pest risk (USDAAPHIS, 2012). Choosing this alternative would not satisfy the purpose and need of making a 

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

2.2 Preferred Alternative: Determination that DAS-81419-2 Soybean Is No 

Longer a Regulated Article

Under the Preferred Alternative, DAS-81419-2 soybean and progeny derived from them would 

no longer be regulated articles under 7 CFR part 340. DAS-81419-2 soybean is unlikely to pose 

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a plant pest risk (USDA-APHIS, 2012). Permits issued or notifications acknowledged by 

APHIS would no longer be required for introductions of DAS-81419-2 soybean and progeny 

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

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

and the agency’s authority under the plant pest provisions of the PPA. Because the agency has 

concluded that DAS-81419-2 soybean is unlikely to pose a plant pest risk, a determination of 

nonregulated status of DAS-81419-2 soybean is a response that is consistent with the plant pest 

provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology 

regulatory policies in the Coordinated Framework.

2.3 Alternatives Considered, Not Included in Detailed Analysis

APHIS has assembled a list of alternatives that might be considered for DAS-81419-2 soybean. 

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

provisions of the PPA, and the regulations at 7 CFR part 340, with respect to environmental 

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

DAS-81419-2 soybean. Based on this evaluation, APHIS rejected several alternatives. These 

alternatives are discussed briefly below along with the specific reasons for rejecting each. 

2.3.1 Prohibit Any DAS-81419-2 from Being Released 

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

marketplace, APHIS considered prohibiting the release of DAS-81419-2 soybean, including 

denying any permits associated with the field testing. APHIS determined that this alternative is 

not appropriate given that APHIS has concluded that DAS-81419-2 soybean is unlikely to pose a 

plant pest risk (USDA-APHIS, 2012). 

In enacting the PPA, Congress listed findings in Section 402(4), including the following one:

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

under this title [the Plant Protection Act] shall be based on sound science;”

On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide agencies that develop and 

implement policies for oversight of emerging technologies such as genetic engineering. In 

accordance with this memorandum, agencies should adhere to guidance in Executive Order 

13563, and, consistent with it, apply the following principle, among others to the extent 

permitted by law when regulating emerging technologies:

“Decisions should be based on the best reasonably obtainable scientific, technical, economic, and 

other information, within the boundaries of the authorities and mandate of each agency” 

Based on the PPRA (USDA-APHIS, 2012), and the scientific data evaluated therein, APHIS 

concluded that DAS-81419-2 soybean is unlikely to pose a plant pest risk. Accordingly, there is 

no basis in science for prohibiting the release of DAS-81419-2 soybean.

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2.3.2 Approve the Petition in Part 

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole or 

in part.” For example, a determination of nonregulated status in part may be appropriate if there 

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

has concluded that DAS-81419-2 soybean is unlikely to pose a plant pest risk, (USDA-APHIS, 

2012), and it is the only line described in the petition, there is no regulatory basis under the plant 

pest provisions of the Plant Protection Act for considering approval of the petition only in part. 

2.3.3 Isolation Distance between DAS-81419-2 Soybean and Non-GE Soybean 

Production and Geographical Restrictions 

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating DAS-81419-2 soybean from conventional 

or specialty soybean production. However, because APHIS has concluded that DAS-81419-2 

soybean is unlikely to pose a plant pest risk (USDA-APHIS, 2012), an alternative based on 

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

provisions of the PPA and regulations in 7 CFR part 340.

APHIS also considered geographically restricting the production of DAS-81419-2 soybean based 

on the location of production of non-GE soybean in organic production systems or production 

systems for GE-sensitive markets in response to public concerns regarding possible gene 

movement between GE and non-GE plants. However, as presented in APHIS’ PPRA for DAS81419-2 soybean, there are no geographic differences associated with any identifiable plant pest 

risks for DAS-81419-2 soybean (USDA-APHIS, 2012). This alternative was rejected and not 

analyzed in detail because APHIS has concluded that DAS-81419-2 soybean does not present a 

plant pest risk, and will not exhibit a greater plant risk in any geographically restricted area. 

Therefore, such an alternative would not be consistent with APHIS’ statutory authority under the 

plant pest provisions of the PPA and regulations in Part 340 and the biotechnology regulatory 

policies embodied in the Coordinated Framework.

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

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

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

provisions of the PPA. However, individuals might choose on their own to geographically 

isolate their non-GE production systems from DAS-81419-2 soybean or to use isolation 

distances and other management practices to minimize gene movement between soybean fields. 

Information to assist growers in making informed management decisions for DAS-81419-2 

soybean is available from the Association of Official Seed Certifying Agencies (AOSCA, 2011).

2.3.4 Requirement of Testing for DAS-81419-2 Soybean

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

requested USDA to require and provide testing for GE products in non-GE production systems. 

APHIS notes that there are no nationally-established regulations involving testing, criteria, or 

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limits of GE material in non-GE systems. Such a requirement would be extremely difficult to 

implement and maintain. Additionally, because DAS-81419-2 soybean does not pose a plant 

pest risk ( USDA-APHIS, 2012), the imposition of any type of testing requirement is inconsistent 

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

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for DAS-81419-2 soybean would not meet APHIS’ purpose and 

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

2.4 Comparison of Alternatives 

Table 1 presents a summary of the potential impacts associated with selection of either of the 

alternatives evaluated in this Environmental Assessment. The impact assessment is presented in 

Section 3.

Table 1. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action Alternative B: Preferred 

Alternative. Determination 

of Nonregulated Status

Meets Purpose and Need 

Objectives

No Yes

Unlikely to Pose a Plant Pest

Risk

Satisfied through use of 

regulated field trials

Satisfied by USDA-APHIS 

Plant Pest Risk Assessment

Management Practices 

Acreage and Areas of Soybean 

Production

Continuing under APHIS 

notification and EPA permits 

only, no change in current 

soybean acreage

Under EPA seed increase 

permits only, no large overall 

change in total soybean 

acreage is expected; existing 

soybean acres will be used for 

new seed production. If DAS 

chooses commodity

production for DAS-81419-2, 

this will replace existing 

varieties.

Agronomic Practices Standard practices will be 

maintained

Standard practices will be 

maintained for small scale 

seed production. If the crop is 

commercialized for the US 

market, less insecticide will be 

used in treating lepidopteran 

infestations. Some increase in 

glufosinate use may occur if 

the developer decides to 

pursue US commercialization

of the trait.

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Soybean Seed Production Unchanged Practices for seed production 

will remain similar to current 

seed production, including the 

unlikely use of glufosinate for 

weed control. 

Organic Soybean Production No expected changes in 

production of organic soybean

varieties. Specialty crop 

growers employ practices and 

standards for seed production, 

cultivation and product 

handling and processing to 

ensure that their products are 

not pollinated by or 

commingled with 

conventional or GE crops. 

Certified organic soybean 

acreage is a small but 

increasing percentage of 

overall soybean production.

No expected change in 

organic soybean practices or 

increase in present total 

acreage of GE soybean

Environment

Water Resources No expected changes to water 

resources

No expected changes to 

soybean seed production or to 

water resources; if used in 

areas with Lepidopteran pests, 

use could decrease

insecticides in water

Soil Quality Unchanged If released commercially for 

commodity soybean 

production, some regions with 

economically important 

lepidopteran pests may have 

decreased insecticides in soil

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Biological

Animal Communities Unchanged. Under 

notifications test protocols are

required that confine the seed 

and plant variety to prevent 

environmental impacts

DAS-81419-2 is not expected 

to have any effect on 

vertebrate animals or most

invertebrate animals. DAS81419-2 exhibits insecticidal 

activity against certain

lepidopteran insects. Those

pests that feed directly on 

DAS-81419-2 soybeans would 

be expected to die or have

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delayed growth. If DAS81419-2 soybean is 

commercialized in the U.S., 

there are potential benefits due 

to reduced insect pressure and 

reduced need for insecticide 

applications

Plant Communities The most agronomically

important members of the 

surrounding plant community 

are often those that behave as 

weeds. Soybean growers use 

production practices to 

manage weeds in and around 

fields. Resistant weeds will 

continue to increase because 

of the use of herbicides, 

especially glyphosate

No increased impacts because 

only seed production will be 

increased and glufosinate will 

likely not be used; if 

commercialized, may be a 

trend in some parts of the 

country for increased 

glufosinate use against 

glyphosate resistant weeds. No

large increase in acres planted 

to DAS-81419-2 expected, so 

considerable change in 

glufosinate use is not likely.

Gene Flow and Weediness Cultivated soybean varieties 

can cross-pollinate. Growers 

use various production 

practices to limit undesired 

cross-pollination

Unchanged from No Action 

Alternative

Soil Microorganisms Unchanged Unchanged

Biological Diversity Unchanged Unchanged

Human and Animal Health

Risk to Human Health Unchanged. EPA regulates the 

safe use, handling and 

exemptions from tolerances 

for all pesticides

Unchanged. EPA regulates 

the safe use, handling and 

exemptions from tolerances 

for all pesticides

Risk to Animal Feed Unchanged. Processed 

soybeans are the largest source 

of protein in animal feed

Unchanged. A compositional

analysis concluded that forage 

and grain from DAS-81419-2 

soybean hybrids are 

considered similar in 

composition to forage and 

grain from both the nontransgenic comparator and 

conventional soybean hybrids. 

Therefore this is unchanged 

from the No Action 

Alternative.

Socioeconomic

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Domestic Economic 

Environment

No new impacts. The 

widespread adoption of 

herbicide-resistant soybean 

has been attributed to cost 

savings for production, and

also non-monetary benefits.

If commercialized, then 

somewhat less use of 

insecticides in some parts of 

the country. Seed production 

may modestly increase

Trade Economic Environment Likely no change of exported

soybean seed for planting. 

Developer will not increase 

foreign sales of seed produced 

unless DAS-81419-2 is 

determined as nonregulated.

May increase exports of 

soybean seed for planting to 

some markets, especially 

South American markets. 

DAS intends to submit 

dossiers to request import

approval of DAS-81419-2 

soybean to the proper 

regulatory authorities of 

several countries that already 

have regulatory processes in 

place for GE soybean. These 

include, but are not limited to: 

Canada, Mexico, Japan, the 

EU, South Korea, and China.

Other Regulatory Approvals

U.S. FDA food consultation 

complete, EPA Cry1F 

tolerance exemptions and 

conditional pesticide 

registrations complete

FDA food consultation 

complete, EPA Cry1F 

tolerance exemptions and 

conditional pesticide 

registrations complete

Other Countries Currently seeking foreign 

approvals for feed and food

Will seek approvals from 

South American countries for 

planting. Currently seeking 

foreign approvals for feed and 

food

3 AFFECTED ENVIRONMENT

3.1 Soybean Agricultural Production and Practices

3.1.1 Areas and Acreage of Soybean Production

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

and protein. Domestically, soybean plants are grown for their seed, which is processed to yield 

oil and meal. Soybean is ranked number one in oil production (56 percent in 2011) among the 

major oil seed crops produced globally (The American Soybean Association, 2012a).

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3.1.2 Land Use

As of 2007, there were about 406 million acres of cropland in the U.S., of which approximately 

332 million acres (including harvested, failed crops, and cultivated fallow) were used for crop 

production (USDA NASS, 2007a). The remaining cropland was either idle or was used for 

pasture. From 1991 to 2011, acreage planted with soybean increased from just over 59 million 

acres to approximately 75 million acres (Figure 1) (USDA NASS, 2011b; USDA NASS, 2011c; 

USDA NASS, 2011a). The acreage planted in 2013 is estimated at 77.1 million acres (USDANASS, 2013c)

U.S. Soybean Acres

1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2013

--◊-- Planted --■--Harvested

Figure 1. Planted and harvested acreage of soybeans in the U.S. (1991-2011).

Source: (USDA NASS, 2011a)(2012f).

In the U.S., as cited 77.1 million acres of soybeans were planted by August 2013 (USDA-NASS, 

2013d). Of these planted acres, about 75.7 million acres were harvested, valued at over $40

billion from estimates of $12.50-15.30/bu -and 3.26 billion bu production which is an 8% 

increase in soybean production from last year (USDA-NASS, 2013b). The majority of 

soybeans produced in the U.S. are grown in 31 states (Table 1), with about 80% of the planted 

soybean acres and 80% of the harvested soybean acres concentrated in 11 states: Iowa, Illinois, 

Minnesota, Indiana, Missouri, Nebraska, Ohio, South Dakota, North Dakota, Kansas, and 

Arkansas.

Table 2. U.S. soybean production, 2012 and 2013.

State

Acres Planted

(x 1,000)

Acres

Harvested

 2012 2013 2012 20131 

Alabama 340 430 335 420

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Arkansas 3200 3250 3160 3200

Delaware 170 165 168 163

Florida 21 32 20 30

Georgia 220 230 215 220

Illinois 9050 9450 8920 9400

Indiana 5150 5200 5140 5180

Iowa 9350 9300 9300 9230

Kansas 4000 3600 3810 3540

Kentucky 1480 1654 1470 1640

Louisiana 1130 1120 1115 1080

Maryland 480 480 475 475

Michigan 2000 1900 1990 1980

Minnesota 7050 6700 6990 6630

Mississippi 1970 2010 1950 1980

Missouri 5400 5600 5260 5640

Nebraska 5050 4800 4990 4750

New Jersey 96 89 94 87

New York 315 275 312 272

North Carolina 1590 1460 1580 1440

North Dakota 4750 4650 4730 4610

Ohio 4600 4450 4580 4430

Oklahoma 420 345 260 310

Pennsylvania 530 520 520 510

South Carolina 380 320 370 310

South Dakota 4750 4600 4710 4550

Tennessee 1260 1560 1230 1520

Texas 125 105 110 90

Virginia 590 600 580 590

West Virginia 21 22 20 21

Wisconsin 1710 1580 1700 1570

United States 77,198 77,728 76,104 76,918

Source: USDA-NASS, 2013 Acreage Report and November 2013 Crop Production Report

(USDA-NASS, 2013a; USDA-NASS, 2013c)

Over the last 20 years, soybean production has increased 35%, from nearly 2.0 billion bushels

(43.1 million metric tons) in 1991 to approximately 3.0 billion bushels (64.6 million metric tons) 

in 2011. Average yield increased during this period approximately 17.6% from 34.2 bushels per 

acre in 1991 to 41.5 bushels per acre in 2011 (USDA NASS, 2011c). USDA agricultural 

projections for 2020 estimate about 3.5 billion bushels (76.3 metric tons) of soybean will be 

produced, of which approximately 2.0 billion bushels (43.1 million metric tons) will be for 

domestic consumption and 1.5 billion bushels (33.2 million metric tons) for export in that year 

(USDA, 2011b).

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3.1.3 Agronomic Practices 

3.1.3.1 Cultivation, Crop Rotation, Tillage and other Standard Agronomic 

Practices

Crop rotation is the successive planting of different crops in the same field over a particular 

period of years. Crop rotation has two primary goals: sustaining the productivity of the 

agricultural system and maximizing economic returns (Hoeft et al., 2000). Sustaining the 

agricultural system is achieved by rotating crops that may improve soil health and fertility with 

more commercially beneficial “cash crops”. Since soybean fixes nitrogen in soil, the yield of 

some crops following soybean, such as corn or wheat, may increase (Berglund and Helms, 

2003). This shows for example that 64% of crops planted following soybean within the US in 

2008 were corn, and for the southeastern states, 53% of crops planted were another planting of 

soybean.

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

for space, water, and nutrients. Tillage in soybean production systems is used to prepare a 

seedbed, address soil compaction, incorporate fertilizers and herbicides, manage water 

movement both within and out of a production field, and control weeds (Heatherly et al., 2009). 

Field preparation is accomplished through a variety of tillage systems, with each system defined 

by the remaining plant residue on the field. Types of tillage systems utilized include 

conventional, reduced, conservation (including mulch-till, strip-till, ridge-till, and no-till), and 

deep (primary). Various conservation tillage practices rely more or less primarily on use of 

herbicides for weed control.

3.1.3.2 Herbicide Use and Weed Management

Herbicide use is regulated by EPA, and the agency assesses the risks to human health as well as

risks to nontarget organisms and the environment. EPA establishes use requirements to protect 

the health of humans and safety for the environment. Herbicides have been the primary tactic to 

manage weed communities in soybeans since the mid-1960s and will continue to be an important 

feature of row crop weed management for the foreseeable future. One study looked at aggregate 

data on crop yield losses and herbicide use and estimated that even if additional tillage and hand 

weeding labor replaced the use of herbicides, U.S. crop production would decline by 20% with a 

$16 billion loss in value if herbicides were not used (Gianessi and Reigner, 2007) and Reigner, 

2007). 

The presence of weeds in soybean fields is a primary detriment to soybean productivity. Weeds 

have been estimated to cause a potential yield loss of 37% in world-wide soybean production 

(Heatherly et al., 2009). Weeds compete with soybean for light, nutrients, and soil moisture,

harbor insects and diseases, and interfere with harvest, causing extra wear on harvest equipment 

(Loux et al., 2008). In addition to weed density, the time period that weeds compete with the 

soybean crop influences the level of yield loss. The later the weeds emerge, the less impact they 

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will have on yield. Soybean plants withstand early-season weed competition longer than corn, as 

the soybean canopy closes earlier (Boerboom, 2000). The extent of canopy closure restricts the 

light available for weeds and other plants growing below the soybean. In addition, canopy 

closure occurs more quickly when soybean is drilled or planted in narrow rows (Boerboom, 

1999); however, in some studies it has also been observed that, depending on factors such as 

weed species, environmental conditions (i.e., rainfall amounts), and soybean cultivar, soybeans 

are able to compete with weeds with no resulting yield reduction (Krausz et al., 2001; Place et 

al., 2011). Place et al. have determined that larger soybean seeds produce a larger canopy more 

quickly and are, therefore, more successful at outcompeting weeds (Place et al., 2011).

Glufosinate ammonium

Primary responsibility for regulation of pesticides including herbicides is with the US EPA. 

“Pesticide registration is the process through which EPA examines the ingredients of a pesticide; 

the site or crop on which it is to be used; the amount, frequency and timing of its use; and storage 

and disposal practices. EPA evaluates the pesticide to ensure that it will not have unreasonable 

adverse effects on humans, the environment and non-target species. Pesticides must be registered 

or exempted by EPA's Office of Pesticide Programs before they may be sold or distributed in the 

U.S. 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.” (US-EPA, 2013c).

Glufosinate ammonium herbicides contain the active ingredient phosphinothricin and are in the 

phosphinic acid family of herbicides. The herbicide acts by blocking the plant enzyme 

glutamine synthetase, which is responsible for nitrogen metabolism and for detoxifying 

ammonia, a byproduct of plant metabolism. The exposed plant dies by the overproduction of 

ammonia, which leads to cessation of photorespiration (EPA, 2008b). It is a non-selective foliar 

herbicide that is used for the control of broadleaf and grass weeds in a variety of crops and noncrop areas. First registered with the EPA in 1993, initial glufosinate ammonium end-use 

products were for home owner, light industrial non-food, and farmstead weed control (OSTP, 

2001). Glufosinate ammonium was first registered by EPA for use in crops in 2000 as a nonselective foliar herbicide used for pre-plant and post-emergence control of broadleaf weeds (EPA

(US-EPA, 2008), 2008b). Glufosinate ammonium, a water soluble herbicide, is also approved 

for use on apples, berries, canola, corn, cotton, currants, grapes, grass grown for seed, potatoes, 

rice, soybeans, sugar beets, and tree nuts. Non-crop areas for which glufosinate ammonium is a

registered use include residential lawns and industrial and public areas. Products include Rely®, 

Derringer® and Finale® (EPA, 2008b; US-EPA, 2008). Ignite® and Liberty® glufosinate 

ammonium products are registered for selective over-the-top use on GE LibertyLink® corn, 

cotton, canola, rice, and soybean.

The highest agricultural uses of glufosinate ammonium are in corn (900,000 lb a.i./yr), cotton 

(300,000 lb a.i./yr), canola (60,000 lb a.i./yr), almonds (30,000 lb a.i./yr), and grapes (20,000 lb 

a.i./yr) (EPA, 2008b). Potatoes, rice and soybeans account for 10,000 lbs ai/yr per crop (EPA, 

2008b). Glufosinate ammonium-resistant soybean accounted for less than 1 percent of soybean 

acreage planted in the U.S. in 2009 with approximately 72,000 lb a.i. glufosinate ammonium 

applied (USDA-APHIS, 2012a). In 2011, the planted acreage of glufosinate ammonium-tolerant 

soybeans increased to 1.3 percent and glufosinate ammonium use rose to approximately 550,000 

® Finale, Rely®, Ignite®, LibertyLink® and Derringer® are registered trademarks of Bayer CropScience. 

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lb (USDA-APHIS, 2012a). By 2012, glufosinate ammonium use on glufosinate resistant soybean 

increased to nearly 3 million acres and 1.5 million pounds of active ingredient (Orr, G., DAS

personal communication, 2013).

The EPA-registered use of glufosinate ammonium on LibertyLink® (i.e., glufosinate ammoniumresistant) soybean includes an initial application of glufosinate ammonium no higher than 0.66 lb 

a.i./A (36 fl oz/A) with a minimum of 0.40 lb a.i./A (22 fl oz/A) (Bayer CropScience, 2011, p. 

14). A single second application of glufosinate ammonium up to 0.53 lb a.i./A (29 fl oz/A) is 

approved on LibertyLink® soybeans, with a seasonal maximum rate of 1.2 lb a.i./A (65 fl oz/A) 

permitted (Bayer CropScience, 2011). Glufosinate ammonium applications on LibertyLink®

soybean should be made from emergence up to but not including the bloom growth stage and 

within 70 days of harvesting soybean (Bayer CropScience, 2011).

Weed resistance

Not unlike other agronomic practices, herbicide use may impart selection pressures on weed 

communities resulting in shifts in the weed community that favor those weeds that do not 

respond to the herbicide used (Owen, 2008). The shift to herbicide resistance in plants is largely 

a function of the selection of herbicide-resistant traits and is strongly related to the repeated use 

of one or a limited number of herbicides (Norsworthy et al., 2012; Shaw et al., 2012). 

A variety of strategies have been proposed to help farmers deal with resistant weeds

(Norsworthy et al., 2012; Shaw et al., 2012) including:

• The rotation of herbicides with different modes of action;

• Site specific herbicide applications;

• Use of full labeled application rates;

• Crop rotation;

• Use of tillage for supplemental weed control;

• Cleaning equipment between fields;

• Controlling weed escapes;

• Controlling weeds early; and

• Scouting for weeds before and after herbicide applications.

3.1.3.3 Insecticide Use

Agricultural production of soybean is a relatively recent development; soybean did not become a 

major export crop in North America until the 1970s (Smith, 1994). Though insect injury has not 

traditionally resulted in economic losses in most North American growing regions, in recent 

years, losses have been severe in some southern regions of the United States (Catchot, 2011). 

Economic thresholds, defined as the level of insect pressure where benefits from treatment cover 

the cost of treatment, have traditionally been based on $4-6 per bushel soybeans. However, 

recent prices of $12-15 per bushel have significantly lowered economic thresholds associated 

with many soybean pests, expanding the area and number of insecticide treatments applied to 

soybeans (USDA ERS, 2011b). Increases in pest insect populations in soybean have also been 

observed; increases are attributed by some to global warming or insect adaptation to the soybean 

plant (Way, 1994). Lower economic thresholds coupled with higher insect populations favor 

more aggressive pest management strategies (Pedigo, 1996).

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Insect injury can negatively impact yield, plant maturity, and seed quality. Insect injury is most 

often defined by the plant parts that are injured: roots, stems, foliage, or pods. Root- and stemfeeding insect groups typically remain undetected until damage has occurred. Although leaffeeding insects are the most diverse group, pod-feeding insects are generally considered to be 

proportionately more important, because high-value soybean reproductive parts are affected. 

Many soybean foliar feeders are caterpillars (Lepidoptera larvae) in the family Noctuidae. These 

include the soybean looper, Chrysodeixis includens formerly Pseudoplusia includens Walker,

velvetbean caterpillar, Anticarsia gemmatalis Hübner and green cloverworm, Hypena scabra

(Fab.). These species commonly occur sympatrically and procedures are being developed for 

making management decisions that acknowledge combined effects of these pests.

Soybean is attacked by many pests, some of which pose an economic threat. Damage is 

concentrated in certain production regions (Way, 1994). Nine insect species are responsible for 

most insect damage in U.S. soybean production: 

Soybean aphid, Aphis glycines Matsumura

Velvetbean caterpillar (see earlier)

Soybean looper (see earlier)

Green cloverworm (see earlier)

Mexican bean beetle, Epilachna varivestis Mulsant (Coleoptera: Coccinellidae) 

Southern green stinkbug, Nezara viridula (Linnaeus)

Bean leaf beetle, Cerotoma trifurcata Forster (Coleoptera: Coccinellidae) 

Southern green podworm/corn earworm, Helicoverpa zea (Boddie) (formerly Heliothis 

zea) (Lepidoptera: Noctuidae) and 

Green stink bug, Chinavia halaris (Say) (Hemiptera: Pentatomidae) (Higley, 1994; 

Purdue-University-Extension, 2009; Iowa-State-University, 2010) . 

Soybean insect pest populations and the extent of soybean damage vary annually and regionally 

due to differences in climatic and weather conditions, species distributions and environmental 

tolerances and production practices (Way, 1994).

Midwestern States. Generally, soybean insect pest problems are less severe in the Midwest states 

of the U.S. than in other soybean producing areas (Way, 1994). Recently, the most serious 

soybean pest has been the soybean aphid (Purdue-University-Extension, 2009). Green 

cloverworm is the only known lepidopteran pest that occurs frequently in the Midwest; 

cutworms, Agrostis ipsilon (Hufnagel) and Peridroma saucia (Hübner) (Noctuidae) and Painted 

Lady, Vanessa cardui L. (Nymphalidae) have also been reported but are less economically 

important. Economic insect problems increased in the 1990s (Hammond, 2012) with greater 

increases in the north-central U.S. around 2000 (McWilliams et al., 1999). Generally, insect

damage remains below economic threshold levels in the U.S. Midwest. 

Northeastern States. Several insect pests have been reported in the northeastern United States 

and Southern Canada in numbers high enough to cause economic losses in soybean (Penn State 

Extension, 2012). In recent years, the foremost pest of soybean across the Northern US states 

has been the soybean aphid, and although important in states such as Pennsylvania, it is however 

not as prevalent as are economically actionable populations in the Midwest (Iowa-State27
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University, 2010; PennState-Entomology-Extension, 2014). Defoliators include: green 

cloverworm, Japanese beetle, Popillia japonica Newman (Coleoptera: Scarabaeidae), Mexican 

bean beetle, bean leaf beetle, and grasshoppers, Melanoplus spp. (Orthoptera: Acrididae). Sapsucking insects include: soybean aphid, Aphis glycines Matsumura (Hemiptera: Aphididae), 

potato leafhopper, Empoasca fabae (Harris) (Hemiptera: Cicadellidae) and stink bugs (Nezara 

viridula, Acrosternum hilare, Euschistus servus). Stink bugs in particular will feed on both 

foliage and pods. Seedcorn maggots feed on seeds.

Southern States. Insect pressure is generally greatest in the southern U.S. states bordering the 

Gulf of Mexico and the Atlantic Ocean. Stink bugs are responsible for most infestations and 

greatest economic losses in the southeastern United States (McPherson et al., 1997; Guillebeau et 

al., 2008). Lepidopteran insects, primarily soybean looper, velvetbean caterpillar, corn earworm 

(soybean podworm), and lesser cornstalk borer, Elasmopalpus lignosellus (Zeller) (Lepidoptera: 

Pyralidae) are responsible for most of the remaining damage (McPherson et al., 1997; Guillebeau 

et al., 2008). Velvetbean caterpillar and soybean looper are considered the most damaging 

defoliating insects in the South (Way, 1994; Hammond, 2012). Insecticides are used on 

approximately 50% of the soybean acreage in Georgia for lepidopteran pests, with velvetbean 

caterpillar being the most targeted pest (Gianessi et al., 2002). Approximately 40% of the 

soybean acreage in Louisiana is treated with insecticides for lepidopteran pests, with soybean 

looper being the main target (Gianessi et al., 2002).

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

economically justified. The thresholds are commonly based on number of insects found in field 

sampling surveys or on established standard defoliation thresholds, such as those provided pest 

management strategic plans (North Central Integrated Pest Management Center, 2012). In the 

case of insecticides, these economic damage thresholds are used to determine whether the control 

method should be applied. For insect resistant crops, the decision to plant an IR variety is made 

before the crops are planted; some input for this decision may be derived from the insect 

infestation level of the previous season, since the insect eggs or other diapausing stages may be 

found directly in the soil of the field site, such as eggs of corn rootworms that may be laid on 

plant parts. However, velvetbean caterpillars arrive on southern fields as late season arrivals 

from Central and South America (Mississippi-State-University, 2004), so their incidence is 

difficult to anticipate.

Summary data of the latest available USDA-NASS chemical insecticide usage statistics for U.S. 

soybeans from a 2006 survey found that insecticides were applied to 16% of the 72.9 million 

soybean acres planted in surveyed states (excludes restricted use pesticides) in 2006 and 18% in 

2012 (USDA-NASS, 2013e). Of the 12 reported insecticides, the three most common, lambdacyhalothrin, chlorpyrifos, and esfenvalerate, were applied to 6%, 5%, and 3% of the planted 

acres in 2007 and 6%, 6%, and <0.5% respectively in 2012 in surveyed program states (USDA 

NASS, 2007b; USDA-NASS, 2013e). Variability in the historical level of insecticide use from 

year to year may be considerable, and reflects the unpredictability in the U.S. soybean growing 

regions of economic damage from insect pest populations. Use of one chemical, chlorpyrifos, 

attained a usage rate that varied between 2 and 27% on all US soybean between 2004 and 2006 

(USDA-NASS, 2007). Lambda cyhalothrin attained a similar range of use during the interval 

1997-2006 (USDA-NASS, 2007).

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Soybean can withstand 20-35% defoliation before yields are impacted; thus, pesticides are only 

applied when damage reaches economic thresholds. Approximately 15% of the soybean acreage 

in the Midwest region and approximately 25% of the soybean acreage in the Southeast and 

Eastern Coastal regions received an insecticide treatment in 2006, with some states in the 

Southeast requiring treatments on up to 84% of their acreage (USDA-NASS, 2013e).

Regulation and Environmental Oversight of Insecticides by EPA

Insecticide use is regulated by EPA, which addresses product characterization, human health 

risk, ecological risk, and insect resistance management for chemical products as well as products

expressing plant incorporated protectants, such as the Cry proteins. Insecticides generally 

provide effective and economical means of control or suppression of soybean insect pests that 

reach economic thresholds. However, chemical insecticides have limited efficacy in controlling 

lepidopteran infestations in soybean. Narrow application windows, the emergence of insecticide 

resistance, and public pressure for reduced pesticide use limit the desirability of this approach to 

pest management (Thomas and Boethel, 1994). Velvetbean caterpillar and soybean looper are 

considered the most damaging defoliating insects in the South (Way, 1994; Gianessi, 2009). 

Soybean looper has developed extensive insecticide resistance (Thomas and Boethel, 1994), and 

resistance to pyrethroids is widespread across the southern U.S. (Felland et al., 1990; Leonard et 

al., 1990). Insecticides remain effective against velvetbean caterpillar. 

Replacing insecticides with GE plants that produce insect specific toxins (especially the Cry 

proteins) has been shown to reduce the overall volume of insecticide used against target pests. 

For insecticides targeted at larvae of moths and beetles feeding above-ground and on roots, the 

use of GE Insect Resistant (IR) corn by producers through 2010 had reduced the volume of 

applied insecticide active ingredient (ai) by 4.1 million kilograms, or 83.8% (Brookes and 

Barfoot, 2012). Since 1996, the cumulative decrease in insecticide use has been 36.6 million kg, 

a 40% reduction (Brookes and Barfoot, 2012). Efficacy trials of Bt corn hybrids against black 

cutworm, corn earworm, and corn rootworm larvae demonstrate that the addition of pesticides to 

Bt crops does not further increase yield (Estes et al., 2011). For Bt cotton, the reduction in 

volume of applied insecticide active ingredient was 1.19 million kg, or 23% (Brookes and 

Barfoot, 2012). Since 1996, the cumulative decrease in insecticide ai use has been 8.67 million 

kg, a reduction of 9.7% (Brookes and Barfoot, 2012). While those cotton pests not susceptible to 

the currently deployed Cry proteins require insecticide treatments (i.e., Lygus bugs), GE 

lepidopteran-resistant cotton sometimes also require supplementary insecticides when cotton 

bollworm (Lepidoptera) populations have been high enough to require it (Stewart, 2007).

Crops genetically engineered to produce Cry proteins have been widely adopted; Bt cotton now 

represents 75% of the cotton planted in the U.S and Bt corn is about 67% of the corn acreage 

(USDA NASS, 2012c; USDA NASS, 2012b). No soybean engineered with cry proteins have 

been made commercially available in the US at present, although one such soybean line has been 

recognized with nonregulated status, and it expresses the Cry1Ac protein.

Regulation of Cry1F and Cry1Ac proteins. Cry1F Bt proteins are expressed in several US GE 

crop species including corn (DAS 01507-1 and DAS 0675-8) and in cotton (DAS 24236-5), and 

cry1Ac proteins in cotton (DAS-21023-5, MON-15985-7 and MON-00531-6) and corn (DKB29
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89614-9), and soybean which is not presently available in the US (MON-87701-2) (Biosafety 

Clearinghouse, 2013) and in some countries, canola, rapeseed and melons. The cry1F gene

(cry1Fv3) which is transformed into DAS-81419 is the same gene as that was recognized as nonregulated by USDA in 2004, petition 03-036-01 (USDA-APHIS, 2004), and the cry1Ac (synpro) 

was nonregulated also as of 2004, petition 03-036-02, and together these are commercially 

produced as WideStrike cotton.

DAS asserts that Cry1Ac and Cry1F provide protection against several lepidopteran pests of 

soybean, including soybean looper (Chrysodeixis includens (Walker), formerly Pseudoplusia 

includens), velvetbean caterpillar (Anticarsia gemmatalis), fall armyworm (Spodoptera 

frugiperda) and tobacco budworm (Heliothis virescens). Soybean-damaging Lepidoptera that 

are economically the most important species in Brazil for which this product may be directed 

similarly include Chrysodeixis includens (Walker), Anticarsia gemmatalis (Hubner), but also 

Spodoptera cosmioides (Walker), Spodoptera eridania (Stoll), and Spodoptera albula (Walker)

(Rolim et al., 2013).

For the stacked Cry1Ac/Cry1F cotton (WideStrikeTM) whose Bt components are the same as 

those in DAS- 81419-2, EPA addressed product characterization, human health risk,

ecological risk, and insect resistance management for the Bt cotton products. EPA concluded

in their assessment of ecological risk and insect resistance management:

1) no synergistic effects or increase in non-target host range were seen as a result

of combining these two proteins in the same product,

2) aquatic and terrestrial wildlife were not likely to be harmed and WideStrike

cotton was not likely to threaten the long-term survival of any non-target

wildlife populations,

3) the Agency has sufficient information to conclude that there is no hazard from

the proposed uses of WideStrike cotton to non-target wildlife, aquatic and soil

organisms, but they are requesting additional, primarily long term effects data

that were recommended by previous Panels for PIP corn to lend additional

weight to their conclusion.

4) incomplete shared binding of Cry1Ac and Cry1F receptors, in TBW and CBW,

is expected to lead to incomplete cross-resistance and thus the likelihood of

enhanced survival on WideStrike cotton is expected to be small. (US-EPA, 

2005a) 

EPA assessed the potential for possible environmental impacts of the two Cry proteins in 

combination in cotton plants, and as noted, concluded there were “no unreasonable adverse 

effects on the environment” associated with their deployment in cotton. However, the EPA

initially requested additional information over a longer term (US-EPA, 2005a). Since then, there 

have been additional studies, such as one assessing the impacts of green lacewing predators 

feeding on insects that had fed on plants expressing the Cry 1Ac and Cry 1F proteins, and no 

deleterious effects were detected (Tian et al., 2013). A common pest species, fall armyworm,

was fed on Cry1F producing corn, and after two generations of feeding on these larvae by the 

common and abundant ladybird beetle, Coleomegilla maculata, no effects were seen on the 

ladybird; transfer of the toxin could be directly demonstrated from the prey species into this

predator (Tian et al., 2012). Similarly, a predator species Podisus maculiventris (spined soldier 

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bug) was fed larvae of the pest lepidopteran species Spodoptera exigua and these had been raised 

on cotton plants expressing cry1Ac. The Bt can disrupt development and reduce feeding of the 

Spodoptera larvae. The Podisus also took up the toxin, and could not be shown to be affected by 

the exposure (Torres and Ruberson, 2008) .

Multiple Bt proteins may have additive or synergistic effects on susceptible lepidopteran species

such as those observed for the cotton pests H. zea and S. frugiperda (Stewart et al., 2001). 

However, for insects not susceptible to single cry proteins, no effects were observed from 

feeding up to three simultaneous cry proteins. For example, larval honeybees consume Cry

proteins in pollen within honeybee cells and when fed multiple cry proteins show no effects

(Hendriksma et al., 2012). Likewise, risk assessment of the effects on nontarget predators show 

a low likelihood of Cry1Ac and Cry1F protein effects on nontarget individuals (Wolt, 2011). In 

a review of population surveys made of predators and parasites found in a variety of crops 

expressing Cry proteins, Lu (Yu et al., 2011) concluded that no consistent effects can be seen on 

non-target species found on Bt-expressing crops. The more recent observations in scientific 

literature continue to be consistent with the conclusion of the EPA in the 2005 BRAD that the 

“non-target organism effects data are considered sufficient for the period of the conditional 

registration. These data demonstrate that no foreseeable human health hazards or ecological 

effects are likely to arise from the use of the product and the risk of resistance developing to the 

Bacillus thurigiensis Cry1F (synpro) or Bacillus thuringiensis Cry1Ac (synpro) protein(s) during 

the conditional registration is not expected.” (US-EPA, 2005a). Similarly, the EPA concluded in 

the 2013 document that “based on extrapolating from previous studies on Bt proteins... the 

cultivation of event DAS-81419-2 soybean will not result in adverse effects to nontarget 

organisms (US-EPA, 2013b).

Global Assessment of Cry proteins

The food and feed safety of Cry proteins has been assessed by regulatory agencies worldwide, 

and Bt crops have been adopted in numerous countries (Betz et al., 2000). For example, 

WideStrike® cotton (DAS-21023-5; DAS-24236-5, expressing the same Cry1Ac and Cry1F 

proteins as DAS-81419-2 soybean) has received regulatory approval in Canada (import), 

Australia (food, feed), Brazil (cultivation, food, feed), Japan (import, food, feed), Mexico (food, 

feed); EU (food, feed) and Korea (food, feed) (Biotechnology Industry Organization, 2012).

Insect Resistance Management

EPA considers protection of insect pest susceptibility to Bt to be in the “public good” (EPA, 

2001). In order to delay the development of insect resistance to Bt crop plant-incorporated 

protectants, EPA has mandated specific requirements on registered PIPs that are intended to 

reduce the potential for insect pests to become resistant to the Bt proteins (EPA, 2001). These 

requirements are part of the terms and conditions of the registrations (EPA, 2001). These 

provisions include the following items:

• Additional field research on pest biology;

• Monitoring for the development of resistance or increased tolerance to the Bt protein;

• Grower education;

• Development of a remedial action plan in case resistance is identified;

• Increased communication among growers, producers, researchers, and the public; and

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• Use of refuges to provide non-resistant insects to dilute the genes of any resistant insects 

in the pest population.

Another key component of IRM is the planting of refuges. An example of a refuge is a block of 

non-Bt corn planted near a Bt corn field. For many PIP products, EPA registrations require that 

such a refuge be planted by growers of the PIP crop. The aim of this strategy is to provide an 

ample supply of insects that remain susceptible to the Bt toxin. The non-Bt refuge will greatly 

decrease the odds that a resistant insect can emerge from a Bt field and choose another resistant 

insect as a mate. The likelihood that two insects with a resistant gene will find each other and 

mate is greatly decreased. By preventing the pairing of resistant genes, these refuges help ensure 

that susceptibility is passed on to offspring (EPA, 2002a).

Integrated Pest Management (IPM) programs integrate preventive pest management with 

additional pest control tools, including insecticides when warranted. IPM practice includes 

monitoring fields for insect growth stage, insect development and population density, and 

occasionally natural enemy development and population density. Management decisions for 

insect populations in individual fields are based on economic injury level, which is defined as the

lowest population density of each insect likely to cause economic damage. The economic injury 

level usually changes during the growing season, with later stages of development warranting 

action at a lower level of defoliation. IPM programs integrate chemical control and biological 

control, cultural control, and plant resistance to minimize insecticide resistance and reduce 

dependence on insecticides (Pedigo, 1996).

3.2 Soybean Seed Production

In 2012, 76.1 million soybean acres were planted (USDA NASS, 2012a). Several factors 

influence optimal planting rate for soybean such as row spacing, seed germination rate, soil 

conditions, climate, disease and pest pressure, past tillage practices and crop rotation (Robinson 

and Conley, 2007). Seeding rate is also determined by the plant population desired by the 

grower. Since 93% of the 76 million soybean acres planted in the U.S. in 2012 were GE 

varieties (USDA NASS, 2012a), at least 70.8 million acres were planted with certified seeds. 

The four largest producers of GE seed combined (Monsanto, DuPont Pioneer, DAS and 

Syngenta) have about 70% of the GE soybean seed market (AgWeb, 2013). Besides seed from 

these companies, regional and local suppliers sell seed and farm supply brand seed may also be 

available to growers.

The U.S. Federal Seed Act of 1939 requires accurate labeling and purity standards for seeds in 

commerce, and prohibits the importation and movement of adulterated or misbranded seeds (7 

C.F.R. Part 201). The Act recognizes classes of certified seed (USDA, 2012f) seed certification 

and official certifying agencies (USDA, 2012d), and varietal purity standards for seed (USDA, 

2012e). States have also developed laws to regulate the quality of seed available to farmers 

(Bradford, 2006). Most of the laws are similar in nature and have general guidelines for

providing information on the label for the following:

• Commonly accepted name of agricultural seed;

• Approximate total percentage by weight of purity;

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• Approximate total percentage of weight of weed seeds;

• Name and approximate number per pound of each kind of noxious weed seeds;

• Approximate percentage of germination of the seed; and

• Month and year the seed was tested.

Various seed associations have standards to help maintain the quality of soybean seed. The

Association of Official Seed Certifying Agencies defines the classes of seed as follows (AOSCA, 

2012):

• Breeder seed is directly controlled by the plant breeder that developed the variety.

• Foundation seed is the progeny of Breeder or Foundation seed that is handled to most

nearly maintain specific genetic identity and purity.

• Registered seed is a progeny of Breeder or Foundation seed that is so handled as to

maintain satisfactory genetic identity and purity.

• Certified seed is the progeny of Breeder, Foundation, or Registered seed that is so

handled as to maintain satisfactory genetic identity and purity.

These definitions are in accord with those set forth in the Federal Seed Act (USDA, 2012f).

Production of all classes of certified seed requires that: 

1. each certifying agency shall determine that genetic purity and identity are maintained at 

all stages of certification including seeding, harvesting, processing, and labeling of the 

seed;

2. the unit of certification shall be a clearly defined field or fields; 

3. one or more field inspection shall be made prior to harvest and when genetic purity and 

identity can best be determined; and 

4. a certification sample shall be drawn in a manner approved by the certifying agency from 

each cleaned lot of seed eligible for certification (USDA, 2012g). 

Federal regulation 7 CFR §201.76 specifies minimum land, isolation, field, and seed standards 

required for soybean Foundation, Registered and Certified seed (USDA, 2012h). To produce all 

classes of certified seed, the land requirement is that the crop shall not be grown on land where 

soybeans were grown the previous year unless the preceding soybean crop was planted with a 

class of certified seed of the same variety or unless the preceding soybean crop and the variety 

being planted have an identifiable character difference. The Federal Seed Act does not specify a

numerical measurement for isolation distances in the production of Foundation, Registered and 

Certified soybean seeds, but states that the distance from any potential contaminating source 

must be adequate to prevent mechanical mixing (USDA, 2012f, Table 5). 

Isolation requirement varies somewhat among states and seed producers. Some states require an 

isolation distance of five feet while other states and seed producers require 10 feet of isolation 

distance (Iowa Crop Improvement Association, 2000; Virginia Crop Improvement Association, 

2012). Under 7 CFR §201.76, to qualify as Certified seed, only one plant of another variety in 

200 soybean plants and 0.5% of seed of other varieties or off-types are permitted. To qualify as 

Registered seed, only one plant of another variety in 500 soybean plants and 0.2% of seed of 

other variety or off-types are permitted. To be certified as Foundation seed, only one plant of 

another variety in 1,000 soybean plants and 0.1% of seed of other variety or off-types are 

permitted (USDA, 2012h).

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3.3 Organic Soybean Production

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

Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic 

farming can be marketed and labeled as “organic” (USDA-AMS, 2012). Organic certification 

involves oversight by an accredited, third-party certifying agent of the materials and practices 

used to produce or handle an organic agricultural product (USDA, 2012j). This oversight 

includes an annual review of the certified operation’s organic system plan and on-site inspections 

of the certified operation and its records. Although the National Organic Standards prohibit the 

use of excluded methods (USDA, 2012i), they do not require testing for the presence of excluded 

methods. Thus, NOP certification is dependent on process and not product. For more details of 

the production of organic soybean, see APHIS Final EAs for other soybean varieties.

3.3.1 Organic Practices

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

organic seed, planting earlier or later than neighboring farmers who may be using GE crops so 

that the crops will flower at different times, and employing adequate isolation distances between 

the organic fields and the fields of neighbors to minimize the chance that pollen will be carried 

between the fields (NCAT, 2003). Although the National Organic Standards prohibit the use of 

excluded methods, they do not require testing of inputs or products for the presence of excluded 

methods. The presence of a detectable residue of a product of excluded methods alone does not 

necessarily constitute a violation of the National Organic Standards (USDA-AMS, 2012). NOP 

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

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

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

used excluded methods and has taken reasonable steps to avoid contact with the products of 

excluded methods as detailed in their approved organic system plan (Ronald and Fouche, 2006; 

USDA-AMS, 2011; USDA-AMS, 2012). 

3.3.2 Weed, Pest, and Disease Control in Organic Agriculture

Weed control in organic systems is accomplished with delayed seeding to avoid spring weeds,

applying fertilizer to growing plants to outcompete weeds, increasing seeding rates, sowing

cover crops, crop rotation, intercropping, flame weeding, hand weeding, and mechanical means

(e.g., tillage) (Kuepper, 2003; Heatherly et al., 2009; Place et al., 2011). Organic crop

production historically employed mulch and ridge tillage practices (NCAT, 2003); however, no

till may be unsustainable in some long-term organic systems because of increasingly poor weed 

control (Teasdale et al., 2007). 

Pest control in organic systems is accomplished with application of natural pesticides, integrated 

pest management techniques (e.g. introduction of beneficial organisms such soil predator and 

parasitic organisms), and some weed control practices, such as crop rotation, intercropping, and 

use of cover crops (Fouche et al., 2000; NCAT, 2003; Michigan State University Extension, 

2012) . 

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Diseases are primarily controlled in organic systems by planting disease-resistant varieties and

with management practices that promote healthy soil, rotating crops, diligently removing

diseased plant material, and plant canopy management (NCAT, 2003; Michigan State University 

Extension, 2012). When physical, mechanical, or biological controls are not sufficient for 

controlling weeds, pests, or disease, only a biological, botanical or synthetic substance approved 

on the national list may be used (USDA, 2011a).

3.3.2.1 Organic Pesticides

There are a number of insecticides approved for use in certified organic production systems, 

mainly non-synthetic compounds or biocontrols. Conditions for use of an insecticide must be 

documented under the National Organic Standard. Generally speaking, pesticides that derive 

from natural materials or living organisms are allowed in organic production if they do not 

contain synthetic additives or are not specifically disallowed on the National List of Allowed and 

Prohibited Substances under(USDA, 2012b) Most synthetic pesticides are not allowed; those 

few that are can be found on the National List under (USDA, 2012a). The Organic Crops 

Workbook lists the approved classes of insecticides used for organic production; the largest 

classes are botanicals, biologicals, oils, fatty acids, minerals, and pheromones (NCAT, 2003). 

3.3.3 Economic/Market Data for Organic Agriculture

USDA-Economic Research Service (ERS) reported the organic crop production data collected in 

2008 (USDA ERS, 2010a). In that year, 125,621 acres of organic soybeans in 28 states were 

harvested (USDA ERS, 2010a), compared to approximately 74.5 million harvested acres of

conventionally produced soybean (USDA NASS, 2011b). In 1995, prior to introduction of 

glyphosate resistant soybeans, organic soybean acreage was 47,200 (USDA ERS, 2010a). Total

U.S. soybean acres that year totaled approximately 63.1 million (USDA NASS, 2012b), thus 

organic soybean acres made up about 0.007% of acres. In 2008, organic soybean production

consisted of about 0.13% of total U.S. soybean production and was valued at approximately

$50.2 million, capturing roughly 0.17% of the overall soybean crop value for that year (USDA 

NASS, 2008). Organic soybean producers generally harvest lower yields than other producers 

(McBride and Greene, 2008; Heatherly et al., 2009). McBride and Greene also found total 

operating costs averaged $30 more per acre and capital costs averaged $60 per acre higher for 

organic soybean producers than for other conventional soybean producers.

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

and record-keeping costs associated with this production method. The study also found that 

while organic soybean costs range from $1 to $6 more per bushel, the average premium is $9 

bushel compared to other production systems (McBride and Greene, 2008).

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Table 3. U.S. certified organic soybean acres by state, 2008.

 U.S. Total 100,390 

125,621

Source: (USDA-ERS, 2010)

3.4 Physical Environment

The types of possible impacts of DAS-81419-2 on physical resources of soil quality, water 

resources, air quality and relationship to climate change are no different than those of other 

soybean crops, and of agriculture in general. These issues have been previously surveyed in 

numerous APHIS EAs. Use of herbicides may impose some potential for environmental impacts 

on soil, water and possibly air resources, but EPA has assessed these for each herbicide, 

including glufosinate, and determined that under FIFRA, use of glufosinate will not cause 

unreasonable risks to human health, workers, or the environment when used as directed on 

product labeling. An ecological impact analysis of environmental fate, transport and degradation 

has been prepared in 2013 for glufosinate in soils, groundwater, surface water (US-EPA, 2013a).

3.5 Biological Resources 

3.5.1 Animal Communities

Animal communities in this discussion include wildlife species and their habitats. Wildlife refers 

to both native and introduced species of mammals, birds, amphibians, reptiles, invertebrates, and 

fish or shellfish. Agriculture dominates human uses of land (Robertson and Swinton, 2005). In 

State Soybeans (acres) State Soybeans (acres)

 2007 2008 2007 2008 

Arizona 241 241

Arkansas 8,374 11,172

Colorado 488 3,502

Connecticut 9 9

Delaware 25 25

Idaho 1 1

Illinois 6,277 7,225

Indiana 888 1,104

Iowa 6,989 19,913

Kansas 639 2,141

Maine 144 194

Maryland 416 437

Michigan 11,320 11,251

Minnesota 25,518 21,229

Missouri 7,893 6,441

Nebraska 5,672 8,825

New York 1,324 5,038

North Carolina 165 94

North Dakota 3,308 3,773

Ohio 3,665 3,951

Oklahoma 80 165

Oregon -- 141

Pennsylvania 1,589 1,753

South Dakota 4,531 4,786

Texas 2,093 2,141

Vermont -- 337

Virginia 360 363

Wisconsin 8,381 9,369

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2011, 917 million acres (approximately 47%) of the contiguous 48 states were devoted to 

farming, including: crop production, pasture, rangeland, Conservation Reserve Program, 

Wetlands Reserve Program, or other government program uses (USDA-ERS, 2012). How these 

lands are maintained influences the function and integrity of ecosystems and the wildlife 

populations that they support.

A wide array of wildlife species occur within the 31 major soybean-producing U.S. states. 

During the spring and summer months, soybean fields provide browse for rabbits, deer, rodents, 

other mammals; birds such as upland gamebirds, while also providing a forage base for insects 

(Palmer et al., 2012). During the winter months, leftover and unharvested soybeans provide a 

food-source for wildlife; however, soybeans are poorly suited for meeting nutrient needs of 

wildlife, such as waterfowl, that require a high-energy diet (Krapu et al., 2004).

Some insects and other invertebrates can be beneficial to soybean production, providing services 

such as nutrient cycling and preying on plant pests. But many insects and invertebrates are 

detrimental to soybean crops, 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); seedcorn 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]; brown [Euschistus spp.]); and velvetbean 

caterpillar (Anticarsia gemmatalis) (Palmer et al., 2012; Whitworth et al., 2012). The principle 

lepidopteran pests for which this variety was constructed are listed in Section 3.1.3.3 of this EA.

While insects are considered less problematic than weeds in U.S. soybean production, insect 

injury can impact yield, plant maturity, and seed quality. Consequently, insect pests are 

managed during the growth and development of soybean to enhance soybean yield (Higley, 

1994; Aref and Pike, 1998). Conventional broad-spectrum insecticides are potentially toxic to 

invertebrates and vertebrates. The US-EPA requires application control measures for certain 

Restricted Use insecticides to limit human and environmental exposure (EPA, 2012e). Bt foliar 

sprays contain Cry proteins and are approved insecticides for use in organic production systems 

to control moths, beetles, mosquitoes, and flies (Lepidoptera, Coleoptera, and Diptera), and 

exhibit low toxicity to non-target organisms (EPA, 2011b).

Insect-resistant crop varieties are targeted to certain invertebrate species that negatively impact 

the crop. Currently, GE varieties with nonregulated status are Lepidopteran resistant (European 

corn borer and other species in corn, and additional lepidopteran species in cotton and soybean) 

or Coleopteran resistant (corn rootworm in corn). 

Transgenic Bt crops containing Cry proteins could potentially affect non-target invertebrates that 

directly consume Bt plant material or are exposed via Cry protein residues in soil, water, or prey 

species. However, for a Cry protein to exert toxicity, the appropriate activating enzyme(s) and 

receptor binding sites would need to exist in the midgut of the non-target species, and 

sufficiently high concentrations of active Cry protein would have to reach these binding sites. 

Reviews of commercially established GE crops have summarized the general lack of impact of 

Bt expressing varieties on non-target organisms (Yu et al., 2011). 

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Multiple indicator species have been exposed to purified Bt proteins in direct feeding studies; 

these studies have typically not shown any hazard to the tested species, despite exposure to very 

high test concentrations under “no choice” conditions where the species was continually exposed 

through its diet. Some laboratory studies have found an effect, but concluded through refinement 

of exposure models and estimates, or via field studies, that the effect was not adverse or not 

representative of field conditions (Duan et al., 2009).

GE insect-resistant products may reduce broad-spectrum insecticide use. Since the 

commercialization of Bt crops, there have been a substantial number of field studies that have 

demonstrated that non-target invertebrates are generally more abundant in Bt cotton and Bt corn 

fields than in non-GE fields managed with chemical insecticides (Marvier et al., 2007; Lu et al., 

2012; Mannion and Morse, 2012). These studies demonstrate that Bt crops do not cause 

unreasonable or unexpected adverse effects in the environment and that arthropod prevalence 

and diversity is actually greater in Bt crop fields (EPA, 2010a).

3.5.2 Plant Communities 

The plant community surrounding a soybean field is dependent on physical geography of the 

farm and the context of larger areas. Soybean fields can be bordered by other agricultural fields 

(including those of other soybean varieties), woodlands, or pasture and grasslands. From an 

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

that can behave as weeds. Just as with other plants, weeds and theirpressure on agricultural 

crops are also dependent on geography. Two known weed biotypes have been identified and 

confirmed to be resistant to glufosinate ammonium, a glutamine synthase inhibitor herbicide, 

namely goosegrass (Eleusine indica) and Italian ryegrass (Lolium multiflorum). Glufosinate 

ammonium resistant goosegrass has not been identified in the U.S. In 2010, Italian ryegrass with 

resistance to both glyphosate and glufosinate ammonium was confirmed in Oregon (Heap, 2011). 

For a detailed description of weeds and development of weed resistance to herbicides, see 

additional APHIS EAs for other herbicide resistant soybean varieties.

3.5.3 Gene Flow and Weediness 

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

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

presence/abundance/distance of sexually-compatible plant species; overlap of flowering 

phenology between populations; the method of pollination; the biology and amount of pollen 

produced; and weather conditions, including temperature, wind, and humidity (Mallory-Smith 

and Zapiola, 2008). Soybean is considered a highly self-pollinated species, propagated by seed 

(OECD, 2000b).

3.5.4 Microorganisms

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

toxin removal, nutrient cycling, and most biochemical soil processes (Garbeva et al., 2004). 

They also suppress soil-borne plant diseases and promote plant growth (Doran et al., 1996). Bt

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(Bacillus thuringiensis) is a naturally occurring soil bacterium, commonly present in soil

(Shelton, 2012). Nitrogen fixing species such as Bradyrhizobium japonica, which are important 

components of soybean yield and enhancing soil nitrogen, are also found in soil and associated 

with soybean. For a discussion of soil microorganisms, including soybean mutualists, effects of 

GE crops, and impacts of herbicides, see recent APHIS EAs for soybean traits.

3.5.5 Biodiversity 

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

Biodiversity provides valuable genetic resources for crop improvement (Harlan, 1975) and also 

provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic 

introgression, biological control, nutrient recycling, competition against natural enemies, soil 

structure, soil and water conservation, disease suppression, control of local microclimate, control 

of local hydrological processes, and detoxification of noxious chemicals (Altieri, 1999). The 

loss of biodiversity results in a need for costly management practices in order to provide these 

functions to the crop (Altieri, 1999). 

3.6 Human Health 

3.6.1 FDA Review

Public health concerns surrounding crops genetically engineered to accumulate Bt focus 

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

(FFDCA), it is the responsibility of food and feed manufacturers to ensure that the products they 

market are safe and properly labeled. GE organisms for food and feed may undergo a voluntary 

consultation process with the FDA prior to release onto the market. Although a voluntary 

process, thus far all applicants who wish to commercialize a GE variety that will be included in 

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

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

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

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

evaluates the submission and responds to the developer by Biotechnology Consultation Note 

(and Memo) to File (BNF) (FDA, 1997).

3.6.2 EPA Review

Pursuant to FFDCA, before a pesticide can be used on a food crop, EPA must establish the 

tolerance value which is the maximum amount of pesticide residue that can remain on the crop or 

in foods processed from that crop (EPA, 2010b). In addition, the FDA and the USDA monitor 

foods for pesticide residues and enforce these tolerances (USDA, 2011a). If pesticide residues 

are found to exceed the tolerance value, the food is considered adulterated and may be seized. 

The USDA has implemented the Pesticide Data Program (PDP) in order to collect data on 

pesticides residues on food (USDA-AMS, 2010). The EPA uses PDP data to prepare pesticide 

dietary exposure assessments pursuant to the 1996 FQPA. Pesticide tolerance levels for 

glufosinate ammonium have been established for a wide variety of commodities; the tolerance 

for soybean seed is 0.02 parts per million (ppm) (EPA, 2007a).

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

Changes in acreage, crops, or farming practices can affect the amounts and types of pesticides 

used. This in turn affects potential risks to farm workers. Common farm practices, however, can 

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

to control soybean insects is a good common agricultural practice.

3.7 Animal Feed 

Animal feed is the major product derived from soybean meal produced in the U.S. (Soyatech, 

2012). In 2011, approximately 39 million metric tons of soybean meal was produced, about 25

million tons of which was marketed for animal feed, with the largest volumes consumed by 

poultry (48%), swine (26%), and beef (12%). In 2011, about 12 million metric tons of meal was 

used in poultry rations, with 6.3 and 3 million tons in hog and beef rations, respectively (The 

American Soybean Association, 2012b; The American Soybean Association, 2012c). 

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

is the responsibility of feed manufacturers to ensure that the products they market are safe and 

properly labeled. Feed derived from GE soybean must comply with all applicable legal and 

regulatory requirements, which in turn protects human health. To help ensure compliance, GE 

plants used for feed may undergo a voluntary consultation process with FDA before release onto 

the market, which provides the applicant with any needed direction regarding the need for 

additional data or analysis, and allows for interagency discussions regarding possible issues. 

3.8 Socioeconomics

3.6.1 Domestic Economic Environment 

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

consumption (Heatherly et al., 2009). The top ten producing states (Iowa, Illinois, Minnesota, 

Indiana, Nebraska, Ohio, Missouri, South Dakota, Kansas, and North Dakota) accounted for 

more than 80% of this production (USDA, 2012c). These states are located in the USDA-ERS’s 

Heartland (Iowa, Illinois, Indiana, Minnesota, Missouri, Nebraska, Ohio, and South Dakota), 

Northern Crescent (Minnesota and Ohio), Northern Great Plains (Nebraska, Minnesota, North 

Dakota, and South Dakota), Prairie Gateway (Kansas and Nebraska), and Eastern Uplands 

(Missouri and Ohio) resource regions, which vary in terms of land productivity and cost of 

production. The most productive of these regions are the Heartland and Northern Crescent

(USDA ERS, 2012a). While these regions have higher production costs, their higher 

productivity still results in greater profitability (USDA ERS, 2012a). In 2012, the U.S. total 

gross average value of soybean production per planted acre was $388.49 and the average price of 

a bushel of soybeans at harvest was $11.94 (USDA ERS, 2012a). 

As discussed in Section 2.1.2, several insect pests have been reported in the northeastern United 

States and Southern Canada in numbers high enough to cause economic losses in soybean (Penn 

State Extension, 2012). Insect pressure is generally greatest in the southern U.S. states bordering 

the Gulf of Mexico and the Atlantic Ocean; soybean insect pest problems in the Midwest are 

generally less severe (Way, 1994).

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Production cost data are provided by USDA-ERS and collected in surveys conducted every four 

to eight years for each commodity as part of the annual ARMS. In 2010, typical operating costs 

are reported in dollars per planted acre and included purchased seed ($59.20), fertilizer and soil 

amendments ($17.87), other chemicals ($17.04), and irrigation water ($0.16) (USDA ERS, 

2012a). Total 2010 operating costs were $131.89 per planted soybean acre (USDA ERS, 2012a). 

In comparison, 2011 typical U.S. soybean production operating costs per planted acre total 

136.87, including $55.55 for purchased seed, $22.84 for fertilizer and soil amendments, and 

$16.42 for other chemicals, and costs for irrigation water were $0.15 (USDA ERS, 2012a). The 

rise in crop production input prices is attributed to the increased use of more expensive seeds 

with complex genetic traits, increased use of fertilizer that has increased in price primarily in 

response to rising natural gas prices, and a 4% rise in pesticide costs coupled with an increase in 

overall crop acreage (USDA ERS, 2011a).

3.6.2 Trade Economic Environment 

Soybean exports in the form of bulk beans, meal, and oil are a major share of the total

agricultural exports for the U.S. The value of U.S. agricultural exports was $135.77 billion in 

2012 (USDA ERS, 2012h). Bulk soybeans accounted for $19.8 billion of this total, ranking first 

among all agricultural commodities, while soybean meal, at a value of $3.84 billion, and soybean

oil, at a value of $1.82 billion, ranked 6th and 16th, respectively (ERS, 2012). The U.S. was 

responsible for 44.0% of the world’s bulk soybean exports, 18.2% of the world’s soybean meal 

exports, and 16.8% of the world’s soybean oil exports (USDA, 2012k; USDA ERS, 2012d; 

USDA FAS, 2013).

In 2010, the U.S. was responsible for 35.1% of the world’s soybean production, 22.9% of 

world’s soybean meal production, and 23.0% of the world’s soybean oil production (USDA 

ERS, 2012d; USDA FAS, 2013). The U.S., China, Argentina, and Brazil are the major 

producers of soybean, soybean meal and soybean oil (USDA, 2012k; USDA FAS, 2013).

The U.S., along with Brazil, Argentina, Paraguay, and Canada, account for 97% of the bulk 

soybean exported worldwide; Argentina, Brazil, the U.S., India, and Paraguay account for 94.1% 

of the soybean meal exported worldwide (USDA, 2012k; USDA FAS, 2013). Argentina, the 

U.S., and Brazil are the dominant countries in terms of soybean oil exports (USDA, 2012k; 

USDA FAS, 2013). China, Mexico, and the 27 European Union member countries (EU-27) 

were the top 3 importers for U.S. soybean by volume for 2010 and 2011 (USDA, 2012k; USDA 

FAS, 2013). 

Currently, soybean seeds for planting are a small percentage of U.S. soybean exports (USDAAPHIS, 2011a; USDA, 2013). From 2005-2010, Chile and Argentina were the largest South 

American importers of U.S. soybean seed for planting (USDA-APHIS, 2011a).

4 ENVIRONMENTAL CONSEQUENCES 

This analysis of potential environmental consequences addresses the potential impact to the 

human environment from the alternatives analyzed in this environmental assessment. A 

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

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

for DAS-81419-2 soybean are described in detail throughout this section. An impact would be 

any change, positive or negative, from the existing (baseline) conditions of the affected 

environment (described for each resource area in Section 3.0). Impacts may be categorized as 

direct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed 

action without intermediate steps or processes. Examples could include soil disturbance, air 

emissions, and water use. An indirect impact may be an effect that is related to but removed 

from a proposed action by an intermediate step or process. Examples could include surface 

water quality changes resulting from soil erosion due to increased tillage, and worker safety 

impacts resulting from a change in herbicide use. 

A cumulative effects analysis is also included for each environmental issue in Section 5. A 

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

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

future actions. Examples include breeding DAS-81419-2 soybean with other events that are no 

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

impacts result from third-party actions (e.g. EPA, growers). If there are no direct or indirect 

impacts identified for a resource area, then there can be no cumulative impacts. Where it is not 

possible to quantify impacts, a qualitative assessment of potential impacts can be provided. 

Certain aspects of this product and its cultivation may be no different between the alternatives; 

those are described below. 

4.1 Scope of Analysis 

4.1.1 Herbicide use

The conferred resistance of DAS-81419-2 soybean to glufosinate ammonium and use of 

glufosinate ammonium on DAS-81419-2 soybean is considered in the assessment. Use of the 

herbicide is permitted by the EPA on commercially-available resistant soybean varieties. 

Glufosinate ammonium is registered by EPA for use on soybeans at an initial application rate no 

higher than 0.66 lb ai/A (36 fl oz/A) and a single second application up to 0.53 lb ai/A (29 fl 

oz/A) (EPA, 2008b). Glufosinate ammonium applications on glufosinate ammonium-resistant

soybean may be made from emergence up to but not including the bloom growth stage and 

within 70 days of harvesting. A seasonal glufosinate ammonium maximum rate of 1.2 lb ai/A 

(65 fl oz/A of) is the approved use pattern on glufosinate ammonium-resistant soybeans (Bayer 

CropScience, 2011). For seed production, DAS notes that they do not expect that glufosinate 

will be used regularly (L. Han, personal communication, 2013)

4.1.2 Stacking

DAS intends to develop a stacked variety through conventional breeding techniques combining 

the insect resistance from DAS-81419-2 soybean with herbicide resistance from another 

nonregulated genetically engineered soybean variety. Environmental consequences associated 

with potential future stacking in which additional herbicide resistance is incorporated with DAS81419-2 soybean are presented and discussed in the cumulative impacts analyses where 

appropriate.

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4.2 Agricultural Production of Soybean 

4.2.1 Acreage and Area of Soybean Production 

Soybean acreage over the long term is not expected to change much, as the USDA Office of the 

Chief Economist indicates 76 million acres for 2013/2014, with the same acreage for 2022/2023 

(USDA-OCE 2013 (USDA-OCE, 2013). While increased export demand for soybean is forecast 

in the projection, OCE predicts no pressure for increased acreage.

4.2.1.1 No Action Alternative: Acreage and Area of Soybean Production 

Under the No Action Alternative, DAS-81419-2 would continue to be regulated by APHIS under 

7 C.F.R. Part 340. Permits issued or notifications acknowledged by APHIS would still be 

required for introduction of DAS-81419-2 soybean, and measures to ensure physical and 

reproductive confinement would continue. Activities for DAS 81419-2 would be limited, with 

no expected change to acreage and area of soybean production.

4.2.1.2 Preferred Alternative: Acreage and Area of Soybean Production 

Similar to the No Action Alternative, breeding and seed increase activities would have no impact 

on acreage. Other than resistance to a specific order of pests, DAS-81419-2 soybean confers no 

special agronomic benefit compared to other soybean varieties (12-272-01p a2 Sections 8, 9), 

and no change in commercial soybean production area or in total amount of soybean acreage in 

the U.S. is expected. Soybean acres in the US have remained in the range of 75-77 million acres 

between 2004 and 2012 (USDA-ERS, 2013) and production from 2.7-3.3 million bushels. The 

USDA (USDA-OCE, 2013) estimated that soybean acreage will remain about 76 million acres 

through at least 2018. Accordingly, the impacts under the Preferred Alternative are unchanged 

from the No Action Alternative. Area of production of soybean for seed production may 

increase, but overall soybean production area for seed destined for South America would at 

maximum be 250,000 acres of the total commodity soybean production of 77.1 million acres 

(0.3% of the total). DAS has specified that the geographic areas assigned to DAS-81419-2 seed 

increase would likely be the same as that presently being used for DAS seed increase, using 

contract seed producers selected by a third party. The current area in which seed is produced 

thus would not likely change.

4.2.2 Agronomic Practices 

Locations where DAS might produce seed are not determined, nor is the maturity group known 

for the soybean line containing the trait presented for determination of nonregulated status. If we 

can assume that the highest yielding sites will be selected for seed production, we suggest that it 

is likely that production of this variety would be within the center of the Corn Belt, such as 

Indiana, Iowa and Illinois. Practices common in these states would be chosen, and since there 

are no details of production of DAS-81419-2 that differ from those needed for other, similar GE 

soybean varieties, practices would be similar to those common in these areas. 

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4.2.2.1 No Action Alternative: Agronomic Practices 

Under the No Action Alternative, DAS-81419-2 soybean could be produced under APHIS 

notification or permit in the states and counties identified by EPA in the seed increase 

registration. While the scope of activity would be limited, similar agronomic practices that are 

currently used for commercially available soybean seed production would also be used by 

growers of DAS-81419-2.

A variety of herbicide choices are available to growers, including those used for preplant only, 

pre-emergent herbicides often with residual activity, those used as post-emergent herbicides, and

combinations of both (Loux et al., 2013). Growers under third party contract for DAS seed are 

not required under their growing contracts to use specific herbicides for seed production. 

However, the soybean seed production leader for DAS (personal communication, through Lei 

Han, 2013) states that the following herbicides would be typically used for seed production:

Preplant herbicide use:

Valor (Flumioxazin)

Postplant herbicide use:

Classic (Chlorimuron-methyl)

First Rate (Chloransulum-methyl)

Select (Clethodim) 

Marvel (contains active ingredients Fluthiacet-methyl and Fomesafen); 

Marvel and tank mix with Select (active ingredient Clethodim);

Flex Star (Fomesafen) 

4.2.2.2 Preferred Alternative: Agronomic Practices 

Cultivation Area

Under the Preferred Alternative, the planting of DAS-81419-2 would continue to be limited by 

the EPA to a seed increase registration, but would not be regulated by APHIS. 

Insecticide Use

DAS-81419-2 soybean expresses Cry1Ac and Cry1F which are active against lepidopteran pests 

and could reduce the localized use of insecticides for these pests. If DAS were to seek and 

obtain EPA registration for commercial use in the U.S., adoption of DAS-81419-2 soybean 

would be expected in areas where lepidopteran pest pressure exceeds economic thresholds. 

While there is a potential for reduced insecticide use with DAS-81419-2 soybean, any potential 

reduction is unlikely to negatively impact the overall environment, and any effects would likely 

be beneficial. Accordingly, no adverse impacts from insecticide use are expected from a 

determination of non-regulated status. 

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Herbicide Use

With production of seed only, DAS asserts that the seed growers would likely use herbicides that 

are listed in the No Action Alternative (personal communication, L. Han, DAS, 2013). The use 

of glufosinate would be unlikely, since the herbicides used for past seed increases have been 

adequate for the soybean seed production process. Additionally, the glufosinate resistant variety 

was designed for use in fields where glyphosate resistant weeds are a significant issue (DowAgrosciences, 2011) and other herbicides may have either more flexibility for acceptable weed 

height at application to attain control, and other herbicides may better target the more important 

weeds, (M. Krieger, DAS, personal communication, 2013) or the others are possibly more 

economical (see Appendix 1). Thus, no changes in herbicide applications from the No Action 

alternative are expected.

Herbicide resistant soybeans were grown on 93% of the total U.S. soybean acreage in 2012 

(USDA ERS, 2012b). Glufosinate ammonium is registered by the U.S. EPA for use on 

soybeans; glufosinate resistant soybeans have been available to growers since 1996. As use of 

herbicide resistant soybeans is common practice for growers in the U.S., impacts under the 

preferred alternative are the same as under the no action alternative. No action by EPA is 

necessary to approve a new label for the use of glufosinate on the DAS-81419 soybean, and the 

label would be the same as that for Liberty soybean varieties. 

Production Methods

DAS-81419-2 soybean is agronomically equivalent to commercial soybean (Petition 12-272-01p 

a2 Sections 7, 8). Thus, no changes in production methods are expected under the Preferred 

Alternative.

Refugia Required by EPA

EPA will not set requirements for refuge acres for Bt susceptible insects when planting DAS81419 soybean for seed, since the EPA has accepted DAS’ proposal that the total acreage of 

plantings for seed production will be maintained at reduced levels with reference to existing 

soybean or cotton acreage. Consequently, with small plantings, there will be little selection 

pressure on lepidopteran populations for new resistance to Cry 1Ac and Cry 1F. Further, the 

pyramided trait reduces the potential for development of resistance to the Bt Cry proteins 

(L.Han, 2013, personal communication). Planting limits of 20,000 acres per county were 

accepted for soybean growing areas without cotton, 10,000 acres for soybean growing areas with 

at 25,000 or less soybean acres, and 1,000 acres in cotton growing areas where soybean has 

25,000 acres or greater (US-EPA, 2013e). 

4.2.3 Soybean Seed Production 

While no published estimates of acreage of soybean seed production in the US are known to 

USDA-APHIS, estimates can be made of minimal acreage needed to plant U.S. commodity 

soybean5

. From typical current values APHIS estimates that at least 1.58 million acres of 

5 Assuming a seeding rate of 125,000 seeds per acre, 2500 seeds per pound, then about 50 pounds of seed might be 

needed for an average field. If 76 million acres are planted, then 3.8 billion pounds of seeds for planting are needed. 

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soybean seed are minimally required to produce sufficient soybean seed for planting of the U.S.

soybean commodity.

4.2.3.1 No Action Alternative: Soybean Seed Production 

Under the No Action alternative, any seed production of DAS-81419-2 would require 

notification or permit under APHIS. Accordingly, activities would be highly limited in scope. 

No change to current soybean seed production practices is expected. 

4.2.3.2 Preferred Alternative: Soybean Seed Production 

Under the Preferred Alternative, planting of DAS-81419-2 soybean would not be regulated by 

APHIS. However, current management practices for the production of high quality seed, such as 

those set forth by AOSCA, would also be used for DAS-81419-2 soybean. Land use 

requirements and restrictions on other crops cultivated specified by AOSCA or state certifying 

agencies would be followed (See Section 2.1.3). Isolation distances beyond those needed to 

prevent mechanical mixing are not specified under the Federal Seed Act (USDA, 2012h), though

some state regulations do specify isolation distances (See Section 2.1.3). As earlier noted, DAS

plans to continue soybean seed production using contracted acres in the same areas in which that 

work is currently accomplished.

Accordingly, the Preferred Alternative would have no impact on seed production practices. 

4.2.4 Organic Soybean Production 

Organic production plans prepared pursuant to the NOP include practical methods to prevent the 

unintended presence of GE materials. Typically, organic growers use multiple methods to

prevent unwanted material from entering their fields, many of them following the same system

utilized for the cultivation of certified seed under the AOSCA procedures. These include

planting organic seed only, planting at times earlier or later than neighbors, and using field

isolation practices (NCAT, 2003).

This analysis is based on the premise that producers of non-GE soybean who sell products to 

sensitive markets (e.g., organic or some export markets) use practices that protect their crop from 

unwanted substances. As discussed in sections 2.1.3 and 2,1,4, specialty markets have specific 

requirements, and growers receive a premium for their products (McBride and Greene, 2008). 

Thus, the expectation that specialty growers observe standard protective practices is reasonable.

4.2.4.1 No Action Alternative: Organic Soybean Production 

The availability of soybean seed developed for organic production is expected to remain the 

same under the No Action Alternative. Under USDA and U.S. EPA regulation, DAS-81419-2

soybean acreage would be limited to a small percentage of U.S. soybean growing acreage, and 

company activities would be limited. No changes to organic soybean production are expected.

If 42 bushels of seed were the average production of soybean seed then this would be a rate of 2400 pounds per acre. 

The seed production could be met by total weight of seed needed divided by the weight produced per acre (3.8 

billion #/ 2400#/acre). 

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4.2.4.2 Preferred Alternative: Organic Soybean Production 

Agronomic practices employed to produce organic soybean would remain unaffected by 

selection of the Preferred Alternative. Current NOP regulations do not specify an acceptable 

threshold level for the adventitious presence of GE materials in an organic-labeled product. The 

unintentional presence of the products of excluded methods will not affect the status of an 

organic product or operation when the operation has not used excluded methods and has taken 

reasonable steps to avoid contact with the products of excluded methods as detailed in their 

approved organic system plan (Ronald and Fouche, 2006; USDA-AMS, 2011; USDA-AMS, 

2012). However, certain markets or contracts may have defined thresholds (The Non-GMO 

Project, 2012).

When compared to other GE varieties of soybean, DAS-81419-2 soybean should not present any 

new and different issues and impacts for organic and other specialty soybean producers and

consumers. As detailed in Section 2.4.1., organic producers employ a variety of measures to 

manage identity and preserve the integrity of organic production systems (NCAT, 2003). 

Agronomic tests conducted by DAS found DAS-81419-2 soybean substantially equivalent to the 

non-GE control variety (12-272-01p a2, Section 8). Therefore, pollination characteristics of 

DAS-81419-2 soybean are expected to be similar to other soybean varieties currently available to 

growers. Given the largely self-fertilized nature and the limited pollen movement of soybean 

(Caviness, 1966; OECD, 2000b; Ray et al., 2003; Abud et al., 2007; Yoshimura, 2011), and that 

93% of soybeans grown in the U.S. are GE (USDA NASS, 2012a), no impact on organic farmers 

is expected following a determination of nonregulated status of DAS-68416-soybean when 

organic soybeans are produced in accordance with agronomic practices designed to meet 

National Organic Standards.

Organic soybean farmers would continue to use the same methods as applied in certified seed 

production systems designed to maintain soybean seed identity and meet National Organic 

Standards as established by the NOP. Acreage devoted to organic soybean production is small 

relative to that of GE varieties and has remained relatively steady, only fluctuating between 

122,217 to 125,621 acres between 2005 and 2008 (USDA ERS, 2010a; USDA ERS, 2010b); this 

amount would not be expected to change under the No Action Alternative. 

For these reasons, a determination of nonregulated status of DAS-81419-2 will not result in 

adverse impacts to organic soybean production. 

4.3 Physical Environment 

4.3.1 Soil Quality

The USDA National Resource Conservation Service has identified significant reductions in the 

loss of soil from croplands in the U.S., finding that total soil loss on highly erodible croplands 

and non-highly erodible cropland decreased by 39.2% from 1982 to 2003 (USDA-NRCS, 

2006c). Herbicide-resistant soybean has contributed to this reduction in soil loss through a shift 

towards conservation tillage and the use of cover crops where the cultivation of herbicideresistant varieties and attendant use of post-emergent herbicides replaces manual weed control 

techniques (Cerdeira and Duke, 2006; University of Illinois, 2006). Other benefits to soil of 

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conservation tillage or no-till systems include lower dust generation, decreased fertilizer and 

pesticide use, reduced fuel and labor costs, and conservation of soil moisture. 

4.3.1.1 No Action Alternative: Soil Quality 

Under the No Action Alternative, DAS-81419-2 soybean would remain regulated by APHIS and 

restricted under its EPA registration. No impacts to soil quality are expected.

4.3.1.2 Preferred Alternative: Soil Quality

Under the Preferred Alternative, DAS-81419-2 soybean would not be regulated by APHIS. No 

changes to agronomic practices are required for cultivation of DAS-81419-2 soybean. There are 

no expected increases in land acreage, cultivation, planting, pesticide use, fertilizer use, 

harvesting, or volunteer control compared to planted soybean. Agronomic practices currently 

used for commercially available soybean seed production will also be used by growers of DAS81419-2 soybean, should it be made available for commodity production, for which there are no 

announced plans at present. Glufosinate ammonium is weakly adsorbed to and is highly mobile 

in soil. The herbicide undergoes rapid microbial degradation in soil, and has a short soil residual 

half-life of seven days (WSSA, 2007). 

DAS-81419-2 soybean provides resistance to glufosinate ammonium. As glufosinate ammonium 

is registered by the EPA for use on soybean, growers could apply glufosinate ammonium to 

DAS-81419-2 soybean in those situations where its use was most economically appropriate. As 

noted in the discussion of seed production, however, the use of glufosinate for that use may be 

infrequent and inconsequential. 

Agronomic performance for DAS-81419-2 soybean is equivalent to conventional soybean (12-

272-01p a2, Section 8); thus agronomic practices will be no different between DAS-81419-2 

soybean and conventional varieties. No-till and reduced tillage systems adopted by soybean 

growers will likely continue with cultivation of DAS-81419-2 soybean. These systems have 

resulted in reduced surface water run-off and soil erosion (Locke et al., 2008).

No adverse impacts are expected for the soil microbial populations that maintain soil quality and 

are associated with conventional soybean cultivation. In particular, mutual symbiotic 

relationships between soybean and the Rhizobiaceae and Bradyrhizobiaceae are unlikely to be 

negatively affected. Cry proteins from B. thuringiensis are rapidly degraded in a variety of soil 

types and these proteins do not accumulate (Head et al., 2002; Mendelsohn et al., 2003; 

Dubelman et al., 2005). For some Cry proteins residual amounts of Bt proteins may persist for 

extended periods (Feng et al., 2011), but at biologically insignificant quantities. The EPA 

concluded that available data indicates that there should be minimal short term accumulation of 

Cry1F and Cry1Ac protein in agricultural soil (US-EPA, 2005b). The EPA risk assessment for 

support of a Section 3 seed increase registration for DAS-81419-2 likewise concludes that Cry 

proteins have a short half-life, and are unlikely to affect soil invertebrates or significantly impact 

soil microbiota (US-EPA, 2013b).

Based on the above, no negative impacts to soil quality are expected from deregulation of DAS81419-2 soybean. 

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4.3.2 Water Resources 

Because drought is the most damaging abiotic stress factor, irrigation is the most important 

factor in soybean production (CAST, 2009). The majority of the irrigated soybean acreage 

occurs in the western Corn Belt and mid-southern regions of the U.S. (USDA NASS, 2013). A 

recent agricultural practice aiming to reduce water stress is early planting of early-maturing 

soybeans groups II-V. This practice avoids a large portion of the drought period during the most 

sensitive reproductive stages of this crop (CAST, 2009). 

4.3.2.1 No Action Alternative: Water Resources 

Under the No Action Alternative, DAS-81419-2 production would be limited to soybeangrowing states where it is approved for regulated release by APHIS and EPA. The use of DAS81419-2 in this region under the No Action Alternative is unlikely to change any water use 

requirements.

4.3.2.2 Preferred Alternative: Water Resources 

Under the Preferred Alternative, DAS-81419-2 soybean would not be regulated by APHIS. As 

production of DAS-81419-2 soybean does not require any changes to standard soybean 

cultivation practices (12-272-01p a2, Section 8), a determination of nonregulated status would 

not change the use of irrigation practices. Needs for additional volumes of water are not 

expected; DAS-81419-2 soybeans will likely replace acres already used for soybean production. 

In regard to water quality, planting of DAS-81419-2 soybean may locally reduce the amount of 

insecticides applied to control lepidopteran pests. To the extent that DAS-81419-2 soybean 

reduces the application of insecticides, it could reduce chemical runoff into surface water and 

groundwater. 

DAS-81419-2 soybean provides resistance to glufosinate ammonium, and glufosinate 

ammonium is registered by U.S. EPA for use on soybeans. EPA regulates pesticides under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and 

Cosmetic Act (FFDCA). When EPA registers a pesticide, it approves product composition and 

label language that provides precautionary information and use directions. As part of the 

registration process, the Agency also approves one or more particular uses for the pesticide 

product. No changes to the currently authorized use of glufosinate on soybean are proposed. 

Glufosinate ammonium is highly water soluble, relatively non-persistent in soil, persistent in 

water, and highly mobile (EPA, 2000). Based on laboratory data, EPA has determined that 

glufosinate-ammonium is not volatile (EPA, 2000). Adsorption to suspended solids and 

sediment has been observed to be low to high (EPA, 2000). Biodegradation occurs in anaerobic 

water bodies with a half-life greater than 64 days (EPA, 2000). Surface water may be impacted 

by glufosinate ammonium residues transported by runoff, but EPA label restrictions require 

actions be taken to minimize impacts, such as not applying the herbicide when rainfall is 

forecasted to occur within 48 hours (EPA, 2007c). Glufosinate ammonium has not been found to 

be a source of impairment for any water body designated as impaired under section 303(d) of the 

Clean Water Act (EPA, 2008b). Glufosinate ammonium may leach to groundwater under certain 

conditions (such as soils with high permeability and shallow groundwater), but generally, 

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because it degrades, it is rarely found deeper than 15 centimeters (approximately 6 inches) from 

the soil surface (EPA, 2008b), minimizing its potential to enter groundwater. Glufosinate 

ammonium does not bioaccumulate in fish and has low potential for bioconcentration in aquatic 

organisms (EPA, 2008b).

Based on the above, DAS-81419-2 soybean is not expected to impact water quality or water 

resources. Accordingly no adverse impacts to water resources are expected under the Preferred 

Alternative. 

4.3.3 Air Quality

Traditional agricultural practices have the potential to cause negative impacts to air quality. 

Agricultural emission sources include smoke from agricultural burning, tillage, traffic and 

harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the use of 

nitrogen fertilizer (USDA-NRCS, 2006a; Aneja et al., 2009). Other greenhouse gas (GHG) 

emission sources associated with agricultural production include equipment emissions 

(contributing carbon monoxide, nitrogen oxides, and reactive organic gases), particulate matter, 

sulfur oxides, and direct emissions of N2O from fertilizer application (US-EPA, 2010a).

4.3.3.1 No Action: Air Quality 

Under the No Action Alternative, DAS-81419-2 soybean would remain regulated by APHIS and 

subject to limited acreage under EPA seed increase registration. No impacts to air quality are 

expected.

4.3.3.2 Preferred Alternative: Air Quality 

No impacts are expected to air quality under this alternative. Based on its agronomic 

characteristics, cropping practices for DAS-81419-2 soybean will not differ from those used for 

conventional soybean (12-272-01p a2, Section 8.4). 

Where infestations of lepidopteran pests exceed economic thresholds, the use of insecticides on 

these fields of DAS-81419-2 soybean could be less than that for conventional soybeans. Areas 

where DAS-81419-2 soybean is planted may receive reduced insecticide applications. Though 

localized areas may realize some benefit, nationwide impact is not expected to be significant. 

Glufosinate ammonium has a low volatility and a short residual half-life of about 7 days. 

(WSSA, 2007). Thus, glufosinate ammonium is not considered an atmospheric contaminant 

with potential impacts to air quality. No adverse environmental impacts to air quality are 

expected under the Preferred Alternative. 

4.3.4 Climate Change 

The adoption of herbicide-resistant soybean has reduced air emissions, including GHG, 

following the increased adoption of conservation practices (NRC, 2010). Conservation practices, 

including conservation tillage associated with GE soybean production, requires fewer tractor 

passes across a field (Baker et al., 2005; USDA-NRCS, 2006a). This results in a decrease in dust 

generation and tractor emissions (Baker (Baker et al., 2005; USDA-NRCS, 2006a). Surface 

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residues and untilled organic matter physically hold the soil in place thus decreasing wind 

erosion of soils and pesticide drift in wind-eroded soils (Baker et al., 2005; USDA-NRCS, 

2006a). Reduced tillage also increases sequestration rates of potential carbon emissions from 

soils (Causarano et al., 2006).

4.3.4.1 No Action Alternative: Climate Change 

Under the No Action Alternative, environmental releases of DAS-81419-2 would be limited 

under APHIS regulation and EPA registration. Accordingly, no impacts to climate change are 

expected. 

4.3.4.2 Preferred Alternative: Climate Change 

DAS-81419-2 soybeans will be managed similarly to other soybeans grown for seed, with 

herbicides and insecticides used as needed. While some decrease in insecticide use could occur

due to the lepidopteran resistance conferred by DAS-81419-2, there is unlikely to be a 

measurable change in agricultural practice that might affect climate change. No significant 

change in herbicide use is expected with the addition of glufosinate resistance in DAS-81419-2, 

as herbicides are already applied to the majority of soybean acres produced in the U.S. today. 

Agronomic practices associated with soybean production such as tillage, cultivation, irrigation, 

pesticide application, fertilizer applications and use of agriculture equipment will be the same for 

DAS 81419-2 soybean as for commercial soybean today.

Localized areas may experience a decrease in certain insecticide use on DAS-81419-2 soybeans, 

however, the cultivation, agronomic practices, and/or agricultural land acreage associated with 

growing DAS-81418-2 soybeans is not expected to have any overall negative adverse impact on 

climate change.

4.4 Biological Resources 

4.4.1 Animal Communities

Plants genetically engineered to express Cry proteins have a history of safe use in the U.S. Since 

the mid-1990s, corn and cotton lines that express these proteins have been commercialized 

without deleterious impacts on non-target organisms (Mendelsohn et al., 2003; EPA, 2008a; 

USDA-APHIS, 2011c). The use of transgenic cotton and maize producing Cry1 proteins, 

including Cry1F and Cry1Ac, has been shown to reduce the use of broad spectrum insecticides 

without significant impacts on the diversity of non-target insects (Romeis et al., 2006; Marvier et 

al., 2007; Wolfenbarger et al., 2008; Higgins et al., 2009; Naranjo, 2009). 

DAS-81419-2 similarly demonstrates low probability of potential harm to the environment (12-

272-01p a2, Section 9). Toxicity of Bt proteins results from specific activation through 

proteolytic cleavage at an active site in the protein core; Bt proteins must bind to specific 

receptors in the gut membrane, leading to pore formation and, ultimately, death of the larva

(Arora et al., 2007). Most Bt proteins require an alkaline environment to remain stable. (Arora 

et al., 2007; Bravo et al., 2011). Because Cry1 receptors are not present in non-target birds and 

mammals, this insecticidal protein is not expected to adversely affect vertebrate organisms 

(Pigott and Ellar, 2007). 

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Bt crops exhibit high specificity of the Bt toxins, which minimize the potential toxic effects on 

non-target insects. The use of insecticides, other than Bt crops, may affect non-target organisms 

including honey bees, soil invertebrates, or culturable microbial flora (EPA, 2005c).

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

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

There is ample information indicating that Cry Bt toxins do not negatively affect mammals or 

birds (Betz et al., 2000). Invertebrates can feed on soybean plants or prey upon other insects 

living on soybean plants, as well as in the vegetation surrounding soybean fields. Because the 

Cry proteins expressed by Bacillus thuringiensis are very specific for Lepidoptera, other 

arthropods are not likely to be affected (van Frankenhuyzen, 2009). 

4.4.1.1 No Action Alternative: Animal Communities 

Under the No Action Alternative, DAS-81419-2 soybean would continue to be regulated by 

USDA and EPA, and therefore produced on limited acreage. Accordingly, no negative impacts

to animal communities are expected. 

4.4.1.2 Preferred Alternative: Animal Communities 

Under the Preferred Alternative, agronomic practices used to produce DAS-81419-2 soybeans 

will be the same as those used to produce other conventionally grown GE and non-GE soybeans. 

DAS-81419-2 soybean production will not change total acreage or any cultivation practices for 

conventional, GE, or non-GE soybean production. The Cry1Ac, Cry1F and PAT proteins 

expressed in DAS-81419-2 soybean are not derived from organisms that are known for 

pathogenic or toxic effects and have an established history of safe use in multiple GE crops. Cry 

proteins are specific for insects, and no work has shown effects on other groups of animals when 

animal exposure occurs within the expected range of environmental concentrations. The PAT 

protein present in DAS-81419-2 soybean is equivalent to that produced in other GE crops that 

are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act (USDA-APHIS, 1996; USDA-APHIS, 2001; USDAAPHIS, 2004; USDA-APHIS, 2005). The food and feed safety of the protein was reviewed as 

part of these previous assessments and was shown to present no significant food or feed safety 

risk. A biotechnology consultation on the PAT protein as expressed in glufosinate resistant

soybean lines was conducted by U.S. FDA in 1998 and does not require additional evaluation 

(FDA, 1998a; FDA, 1998b). DAS has also submitted DAS-81419-2 soybean to FDA for a food 

and feed safety and nutritional evaluation; DAS will provide the results of the assessment when 

the FDA completes its review. 

Cry1Ac has an existing exemption from the requirement of a tolerance in all food and feed 

commodities granted by EPA in 1997, as published in the Code of Federal Regulations (EPA, 

2009a). Cry1F has an exemption from tolerance for cotton and corn (EPA, 2012a; EPA, 2012b).

The FDA previously reviewed data on the Cry1Ac and Cry1F proteins as present in DAS-21023-

5 and DAS-24236-5 (FDA, 2004a; FDA, 2004b). The FDA assessed the safety and nutritional 

data provided by DAS with regards to the use of the cotton in food and feed and concluded that 

they have no further questions (FDA, 2004a; FDA, 2004b). DAS petitioned the U.S. EPA for an 

exemption from tolerance for Cry1F in soybean as a component of the application for 

registration for DAS-81419-2 soybean and tolerance for Cry1F proteins in soybean has been 

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issued by the EPA (Federal Register 79, 8293, February 12, 2014). Additionally, a

biotechnology consultation on the Cry1Ac protein in soybean was completed for MON 87701 

soybean in 2010 and does not require additional evaluation by the FDA (USFDA 2010, BNF 

000119). 

DAS completed tests and produced data for the required and voluntarily developed indicator and 

host range species on WideStrikeTM cotton, which contained both Cry proteins. Supplementary 

field data from observations of WideStrike cotton compared to non-Bt cotton showed no 

environmental impacts. EPA concluded that the levels of Cry1F and Cry1Ac protein in the 

cotton variety would not pose unreasonable adverse effects to cotton agroecosystem flora and 

fauna (US-EPA 2005. Available data also indicate that there should be minimal short term 

accumulation of Cry1F and Cry1Ac protein in agricultural soil. In addition, no adverse effect on 

listed endangered and threatened species listed by the US Fish and Wildlife Service was 

expected from the WideStrikeTM cotton registration. More recently, EPA has approved the 

previous toxicity testing done for WideStrike cotton as adequate for the similar levels of Cry 

proteins expressed in DAS-81412-2 (US-EPA, 2013b). 

EPA at the time of registration for WideStrike cotton stated that the Agency was not aware of 

identified significant adverse effects of Cry1F and Cry1Ac proteins on the abundance of nontarget beneficial organisms in any population in the field, whether they were pest parasites, pest 

predators, or pollinators (US-EPA 2005). Field census data submitted to the Agency for 

Widestrike cotton showed minimal to undetectable changes in the beneficial insect abundance or 

diversity. In cotton fields densities of predatory and non-target insects were generally higher on 

Bt crops than non-Bt crops primarily because the Bt crops were not subjected to the same 

number of applications of nonspecific pesticides.

Research has shown no direct adverse effects on insectivorous insects in field and laboratory 

studies with GE plants expressing Cry proteins (Romeis et al., 2006; Marvier et al., 2007; 

Wolfenbarger et al., 2008; Naranjo, 2009). DAS conducted field studies to determine the 

potential for adverse effect on non-target organisms and found that, across study sites, arthropod 

populations associated with DAS-81419-2 soybeans were similar to non-GE near isogenic 

soybean. Based on this data, no adverse effects from cultivation of DAS-81419-2 soybean, 

expressing the Cry1F, Cry1Ac, and PAT proteins, are expected. 

EPA’s Environmental Risk Assessment and Biotechnology Risk Assessment Document for both 

Bt proteins expressed in soybean was bridged to DAS’ Non-Target Arthropod Field study, and 

the previously reviewed toxicity studies of select nontarget organisms in the BRAD for 

WideStrike cotton Bt proteins, and concluded that Cry1F and Cry1Ac proteins are not expected 

to have adverse effects on mammals, birds, plants, freshwater and estuarine/marine fish and 

invertebrates, nontarget insects and other invertebrate species at the environmentally effective 

concentration (US-EPA, 2013b) (US-EPA, 2014). From a recent review of literature related to 

the two Bt proteins, APHIS agrees that the absence of adverse effects on nontarget arthropods is 

consistent with no likely impacts.

Therefore, potential impacts from deregulation of DAS-81419-2 soybean on animal communities

would be unchanged from the No Action Alternative. 

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4.4.2 Plant Communities

Plant communities are varied and adapted to local climate and soil, as well as the frequency of 

natural or human-induced disturbance (Clements et al., 2004). Non-crop vegetation in soybean 

fields is limited by farmers’ cultivation and weed control practices. Plant communities adjacent 

to soybean fields commonly include other crops, borders, hedgerows, windbreaks, pastures, and 

other natural vegetation. The majority of U.S. soybean acres is planted with GE herbicideresistant soybean cultivars, and genetically engineered traits do not change the adaptation to the 

various agronomic environments in which soybean can be produced.

Agricultural practices affect plant communities by exerting selection pressures that influence the 

type and composition of plants present in a community. Preparation of fields for planting of 

crops removes other plants that compete for light and nutrients. Natural selection in frequently 

disturbed environments enables colonization by plants exhibiting early germination and rapid 

growth from seedling to sexual maturity, and the ability to reproduce sexually and asexually 

(Baucom and Holt, 2009). These weedy characteristics enable such plants to spread rapidly into 

areas undesired by humans. 

Weeds are the most important pests in agriculture, competing for light, nutrients, and water and 

can significantly affect yields (Gibson et al., 2005; Baucom and Holt, 2009). Weeds commonly 

encountered in soybean production include water hemp, giant ragweed, common lambsquarters, 

and others. Agronomic practices common in soybean production, such as tillage and herbicide 

use, impart selection pressures on the weed community that can result in shifts in the relative 

importance of specific weeds (Owen, 2008). In aggressive tillage systems, weed diversity tends 

to decline and annual grasses and broadleaf plants are the dominant weeds; whereas, in no-till 

fields, greater diversity of annual and perennial weed species may occur (Baucom and Holt, 

2009), . The most common weed management tactic in U.S. soybean production is to use 

herbicides and for soybean that is most frequently glyphosate. 

Herbicide resistance occurs when a plant survives the application of an herbicide and reproduces, 

passing on its resistance to new generations. Herbicide-resistant weeds can become 

agronomically important as they out-compete crops and require additional resources to affect 

control. Weed species resistant to glyphosate are becoming more prevalent in crop production. 

For example, glyphosate-resistant Palmer pigweed (amaranth) is a major weed problem in the 

Southeast U.S. although increasingly present in the Corn Belt, while glyphosate-resistant 

waterhemp is a problematic weed in Midwestern states (Culpepper et al., 2006) (Owen, 2008; 

Heap, 2013). In response, producers are diversifying weed management tactics in soybean 

production to include alternating crops resistant to different herbicide modes of action that are 

grown on the same field, alternating the herbicide modes of action used with the same crop, 

practicing more crop rotation, and increasing tillage to effect control of herbicide-resistant weeds

(Owen et al., 2011). Weeds are developing resistance to multiple herbicides, but are also 

controlled with adjustments to standard practices, so as to include crop rotation and tillage

(Owen et al., 2011) when overreliance on herbicides obviates such changes.

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4.4.2.1 No Action Alternative: Plant Communities 

Under the No Action Alternative, cultivation of DAS-81419-2 soybean would be under APHIS 

regulation and in limited acreage under EPA registration. No adverse impacts to plant 

communities are expected under this alternative.

4.4.2.2 Preferred Alternative: Plant Communities 

A determination of nonregulated status of DAS-81419-2 soybean is not expected to affect plant 

communities. Risks to wild plants and agricultural productivity from weedy soybean 

populations are low, as volunteer soybean populations can be easily managed (Carpenter et al., 

2002). Plant species that typically inhabit soybean production systems will be managed through 

the use of mechanical, cultural, and chemical control methods. The landscape surrounding a 

soybean field varies depending on the region. In certain areas, soybean fields may be bordered 

by other soybean fields (or any other crop) or may also be surrounded by woodland, rangelands, 

or pasture or grassland areas. These plant communities may be natural or managed plant habitats 

for the control of soil and wind erosion or allocated to serve as wildlife habitats. 

Because DAS-81419-2 soybean contains resistance for applied glufosinate ammonium, growers 

could select this herbicide for use on DAS-81419-2 soybean. Any potential use would remain 

consistent with the per-application and per-year rates approved by EPA, and application would 

be in soybean growing areas where glufosinate ammonium may already be in use. As part of the 

registration of glufosinate use on soybeans, EPA considered the impact on plant communities

(EPA, 2008b). In addition, 93 percent of soybeans today are treated with herbicides; (USDA 

ERS, 2012f) and in 2012, glufosinate was applied to as much as 4% of soybean acres (G.Orr, 

DAS, 2013). Thus, glufosinate will not be a new herbicide, and because this product is not likely 

to require the herbicide for seed production, no changes in impact on plant communities are 

expected from the introduction of glufosinate resistance in DAS-81419-2. 

Based on the above, no negative impacts to plant communities are expected from deregulation of 

DAS-81419-2 soybean. 

4.4.3 Gene Flow and Weediness 

Two forms of gene flow can be evaluated: Vertical gene flow and horizontal gene flow. 

Vertical gene flow, or hybridization and associated introgression, is the movement of genes to 

sexually compatible relatives (Ellstrand, 2003; Quist, 2010). The soybean is considered selfpollinating, and has no wild relatives in the U.S. (OECD, 2000b; USDA-APHIS, 2012b). 

Although some cross-pollination can occur, AOSCA identity protection practices have been 

found adequate to protect against such gene flow (OECD, 2000b; USDA-APHIS, 2012b) . The 

only relatives of soybean are other varieties currently cultivated. In assessing the risk of gene 

introgression from MON 87769 soybean to its sexually compatible relatives, APHIS considered 

two primary issues: 1) the potential for gene flow and introgression to soybean relatives; and 2) 

the potential impact of introgression. Vertical gene flow is discussed below in the analysis of the 

Preferred Alternative.

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4.4.3.1 No Action Alternative: Gene Flow and Weediness 

Under the No Action Alternative, DAS-81419-2 would be grown under APHIS and EPA 

regulatory authority. Any gene flow from commercially available GE cultivars to non-GE 

soybean cultivars is expected to remain unchanged from current conditions. 

4.4.3.2 Preferred Alternative: Gene Flow and Weediness 

Under the Preferred Alternative, no impact on other soybean varieties or production systems is 

anticipated due to gene flow or weediness characteristics of DAS-81419-2 soybean. Agronomic 

properties of DAS-81419-2 soybean have demonstrated equivalence to conventional soybean

(Petition, Section 8), indicating DAS-81419-2 soybean does not have increased weediness 

potential compared to conventional soybean. 

As discussed in Section 2.3.3, soybean is considered a highly self-pollinated species, with heavy 

seeds that are not naturally dispersed, not transported by animals, and lack dormancy. The insect 

resistance traits of DAS-81419-2 soybean do not alter its reproductive characteristics, as the 

genes encoding Cry1F, Cry1Ac, and PAT proteins do not impart any reproductive advantage that 

would increase the probability of weediness.

A measure of the reproductive capacity of plants that are propagated by seed is the number of 

seeds that are produced and the germination and viability of those seeds. Overall, DAS-81419-2

soybean produced similar percentages of viable seed when compared to controls (12-272-01p a2, 

Section 8.3). These results on growth characteristics, seed production and germination indicate 

that DAS-81419-2 soybean is substantially equivalent to conventional soybean (12-272-01p a2, 

Section 8). There is no indication that DAS-81419-2 soybean possesses a selective advantage 

that would result in increased weediness: DAS-81419-2 soybean lacks the ability to persist as a 

troublesome weed and there will be no direct impact on current weed management practices for 

soybean cultivation. 

The PAT protein is unlikely to increase the weediness potential of any plant species, as 

demonstrated by previous agency determinations (USDA-APHIS, 1996; USDA-APHIS, 2001; 

USDA-APHIS, 2004; USDA-APHIS, 2005). The agency has reached the same determination 

regarding Bt proteins Cry1Ac and Cry1F (USDA-APHIS, 1995; USDA-APHIS, 2004; USDAAPHIS, 2011a). Based on all the factors discussed above, a determination of nonregulated status 

of DAS-81419-2 soybean will not impact other soybean varieties through gene flow or 

introgression, nor will it present a greater risk of weediness or invasive characteristics. 

Deregulation of DAS-81419-2 soybean is not expected to have an effect on gene movement. 

4.4.4 Microorganisms 

An adequate soil population of nodulation-inducing bacteria is an important part of soybean 

production. These bacteria must be supplied if a soybean crop has not been recently grown on 

the planted field (Section 4.3.2). Although the bacteria persist for several years in soil, their 

numbers may not be sufficient to insure adequate nodulation (Bottomley, 1992). Various 

commercial sources of inoculants such as multiple strains of Bradyrhizobium can be spread in 

soybean fields around the time of planting, many with similar results (Beuerlein, 2005). From 

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one season to the next, the inoculated bacteria in soil may change characteristics or phenotypes 

and diverge from traits expressed by the original culture (Farooq and Vessey, 2009). 

Bt corn and cotton are known to produce exudates of Cry proteins that can be detected in the soil 

(Sun et al., 2007; Icoz et al., 2008; Lawhorn et al., 2009). The presence of these toxins, 

ubiquitous in the soil under normal conditions, have not shown a negative effect on soil microbes 

(Blackwood and Buyer, 2004; Baumgarte and Tebbe, 2005; Icoz et al., 2008) or on litter 

decomposition processes (Zurbrügg et al., 2010). Additionally, Cry proteins derived from Bt are 

rapidly degraded in a variety of soil types and the proteins typically do not accumulate in soil 

(Head et al., 2002; Mendelsohn et al., 2003; Dubelman et al., 2005). 

Soil type has a large effect on the microbial community and availability of Cry proteins 

(Blackwood and Buyer, 2004). Certain Cry proteins may adsorb rapidly to clay minerals, on the 

clay-sized fraction of soil, on humic soils, and on complexes of montmorillonite-humic acids 

aluminum hydroxypolymers (Saxena and Stotzky, 2001). Some field studies on the persistence 

of Cry proteins released by GE plants showed that Cry proteins do not persist and degrade 

rapidly in soil, although a small fraction may be protected from biodegradation in the plant 

matrix or bound on surface-active particles (Icoz et al., 2008). 

4.4.4.1 No Action Alternative: Microorganisms 

DAS may continue confined trials under both APHIS and EPA regulations, so that the limited 

production of DAS-81419-2 soybean under the No Action Alternative is not expected to have an 

effect on soil microbes. 

4.4.4.2 Preferred Alternative: Microorganisms 

A determination of nonregulated status of DAS-81419-2 soybean would not change the effects of 

planting DAS-81419-2 soybean on soil organisms. Because of the universal existence of 

proteases in microbes, proteins only exceptionally persist in the environment (Satyanarayana and 

Getzin, 1973). The Cry1Ac protein has been used in sprayable Bt formulations for over half a 

century and is present in both WideStrike® cotton event DAS-21023-5 (also described as 3006-

210-23) and Bollgard® cotton event MON 531, as well as a discontinued corn event: 

DBT418Cry1Ac corn) (Mendelsohn et al., 2003; Sanahuja et al., 2011). The Cry1F protein has 

also been used in sprayable Bt formulations and is present in WideStrike® cotton event DAS24236-5 (also described as 281-24-236), as well as, in Herculex® and SmartStax®corn (event 

TC1507) (Mendelsohn et al., 2003; Sanahuja et al., 2011). Laboratory experiments have shown 

that both Cry1Ac and Cry1F are quickly inactivated, and field studies have shown no 

accumulation of the proteins as a result of continuous planting of crops containing these proteins 

(Head et al., 2002; Herman et al., 2002; Shan et al., 2008). It has further been suggested that the 

Cry proteins in general are unlikely to represent a significant risk in the soil environment (Icoz et 

al., 2008).

While Bt exudates can be found in the soil when GE crops that produce Bt toxins are grown, this 

has not had a negative effect on soil microbes in corn or cotton systems. Planting of DAS81419-2 soybean is anticipated in current soybean-growing areas. These are areas where Bt corn 

and Bt cotton that express the two cry proteins are currently grown today with no discernable 

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impacts. Consequently, no negative impacts to soil microorganisms are expected under the 

Preferred Alternative.

4.4.5 Biodiversity 

Many studies over the last 10 years have investigated the differences in biological diversity and 

abundance between GE and non-GE crop fields, particularly those GE crops that are resistant to 

insects (e.g., Bt crops) or herbicides (e.g., glyphosate- or glufosinate ammonium-resistant).

Some studies have found negligible to modest decreases in biological diversity or abundance 

attributed to crops genetically engineered to produce insecticidal proteins or tolerate herbicide 

application for weed management (Ponsard et al., 2002; Pilcher et al., 2005). Other studies 

compared Bt crops to non-GE crops that were unsprayed or sprayed with insecticides and found 

that Bt crops do not cause any overall changes in arthropod abundance or diversity (Torres and 

Ruberson, 2005; Romeis et al., 2006; Chen et al., 2008; Wolfenbarger et al., 2008). A review of 

over 360 research papers concluded that there is no evidence of landscape-level effects from Bt

crops (Carpenter, 2011), other than area-wide reduction in pest populations under particular 

circumstances (Hutchison et al., 2010). Compared to the use of broad-spectrum insecticides in 

agriculture, Bt crops may increase biological diversity in agroecosystems by reducing broadspectrum insecticide use, thus allowing more non-target species to survive (Romeis et al., 2006; 

Marvier et al., 2007). GE crops may generally increase the productivity of cultivated lands, so 

biodiversity is protected because additional land is not needed for the same volume of crop 

production (Raven, 2010).

The use of broad-spectrum insecticides imposes one of the most severe constraints for biological 

diversity in crops (Naranjo, 2005). One of the benefits of Bt crops has been the reduction of 

broad-spectrum insecticide use during production. The use of GE crops producing the Cry 

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

impact on the diversity of non-target insects (Romeis et al., 2006; Marvier et al., 2007; 

Wolfenbarger et al., 2008; Higgins et al., 2009; Naranjo, 2009).

The presence and release of Bt toxins from the aboveground and below ground parts of Bt plants 

may influence microbial diversity. Bt toxin has been found to be present in every major part of 

Bt plants (Sivasupramaniam et al., 2008). However, the presence of Bt toxin in the soil may not 

influence microbial diversity or activity. Studies regarding the effects of Bt on non-target soil 

microorganisms in Bt maize and Bt cotton cultivation found that microbial biodiversity and 

activity were no different than that of their non-Bt counterparts (Shen et al., 2006; Icoz et al., 

2008). 

4.4.5.1 No Action Alternative: Biodiversity 

Under the No Action Alternative, DAS-81419-2 soybean and its progeny would continue to be 

regulated by USDA-APHIS under 7 CFR part 340, and production restricted under U.S. EPA 

Section 3 Seed Increase Registration. Given the limited acreage and regulated plantings, no 

impacts to biodiversity are expected under this alternative.

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4.4.5.2 Preferred Alternative: Biodiversity 

A determination of nonregulated status of DAS-81419-2 soybean will not change the cultivation, 

agronomic practices, or agricultural land acreage associated with growing soybeans. Cry and 

PAT proteins have a history of safe use, with numerous published studies demonstrating that Bt

crops have not had a negative impact on non-target organisms and soil activity. 

In 2005, the EPA in the BRAD for WideStrike cotton with the two Bt genes, concluded that “ in 

general invertebrate abundance studies in Bt crop fields do not show a shift in biodiversity, 

except in cases where the predators are dependent on the pest insect as prey (US-EPA, 2005)”. 

“In contrast, treatment with chemical pesticides, when studied, had significant effects on 

the total numbers of insects and on the numbers within the specific groups. To date the 

available field test data show that compared to crops treated with conventional chemical 

pesticides, the transgenic crops have no detrimental effect on the abundance of nontarget insect populations. However, annual insect monitoring of representative 

commercial fields will continue for long term biodiversity effects assessment (US-EPA, 

2013).”

There is a potential benefit to biodiversity at the regional level due to a reduced use of broad 

spectrum insecticides where DAS-81419-2 soybean is planted (USDA-ERS, 2006; Wolfenbarger 

et al., 2008). A determination of nonregulated status for DAS-81419-2 soybean is not expected 

to have negative impacts on biodiversity. 

4.5 Human Health 

Human health concerns surrounding GE products center on possible toxic, nutritional, or allergic 

effects. Insecticidal Cry proteins from B. thuringiensis have a long history of safe use in food 

crops (EPA, 2001). Their modes of action are highly specific within narrow ranges of related 

insect species; Bt toxins have no mechanism of action on mammals or other vertebrates (Pigott 

and Ellar, 2007; Bravo et al., 2011). 

The US-EPA requires seed registrants to submit tests of potential toxicity and allergenicity of the 

GE proteins in PIPs before they can be approved for human consumption. Tests conducted for 

adverse mammalian impact from ingesting Cry proteins have been negative, even at extremely 

high doses (Wu, 2006). The toxicity of insecticidal Bt proteins depends on binding to specific 

receptors present in the insect midgut (Pigott and Ellar, 2007; Bravo et al., 2011). With regard to 

the specific Cry proteins produced in Bt crops, research demonstrates that this specificity limits 

each protein’s toxic effect to certain insect species (Pigott and Ellar, 2007; Bravo et al., 2011).

Because Cry1Ac and Cry1F are pesticidal substances, EPA has responsibility for setting 

tolerances or issuing exemptions from the requirement of a tolerance for food and feed products. 

Tolerance exemptions are already in place for Cry1Ac in all crops and Cry1F in corn and cotton 

(EPA, 2009a; EPA, 2012a). DAS has submitted an exemption from tolerance for Cry1F in 

soybeans, including toxicology and allergenicity data on the Cry1F protein. The amino acid 

sequences of both the Cry1Ac and Cry 1F protein expressed in DAS-81419-2 soybean are 

identical to those expressed in WideStrike® Cotton (12-272-01_p2, Section 6.1). EPA also 

conducted reviews of the food and feed safety of Cry1F and Cry1Ac proteins for registration of 

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WideStrike® cotton comprising DAS-21023-5 and DAS-24236-5. The EPA determined that 

there is a reasonable certainty that no harm to human health will result from exposure to Cry1F 

and Cry1Ac and that no unreasonable adverse effects on the flora and fauna of the cotton 

agroecosystems are expected (EPA, 2005b). Another assessment of DAS-81419-2 concludes that 

no harm will result from aggregate exposure of the US population to the two Cry proteins or 

genetic material for its expression (US-EPA, 2013d).

EPA also has regulatory oversight for establishing safety of the PAT protein responsible for 

herbicide resistance. Based on a review of toxicity and digestibility data, the EPA has 

determined that there is a reasonable certainty that no harm will result from aggregate exposure 

to the PAT protein and the genetic material necessary for its introduction; EPA has consequently 

established an exemption from tolerance requirement pursuant to FFDCA section 408(j)(3) for 

PAT and the genetic material necessary for its production in all plants (EPA, 1997). 

The PAT protein present in DAS-81419-2 soybean is equivalent to that produced in other GE 

crops that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant 

pest provisions of the Plant Protection Act (USDA-APHIS, 1996; USDA-APHIS, 2001; USDAAPHIS, 2004; USDA-APHIS, 2005). The food and feed safety of the protein was reviewed as 

part of these previous assessments and was shown to present no significant food or feed safety 

risk. A biotechnology consultation on GE soybean expressing the PAT protein was conducted in 

1998: the FDA reviewed the safety and composition data and determined that there were no 

further questions (FDA, 1998a; FDA, 1998b). DAS has also submitted its DAS-81419-2 

soybeans to the FDA for a safety and nutritional evaluation and provided the results of the 

assessment when the FDA completed its review. On February 7, 2014, FDA concluded that it 

had no further questions about use of DAS-81419-2 in food or feed (BNF-000140).

4.5.1.1 No Action Alternative: Human Health 

Under the No Action Alternative, any field production of DAS-81419-2 soybean will be 

confined by USDA by notification permit regulations and restricted by EPA permit regulations. 

Consumers are expected to have limited exposure to DAS-81419-2 soybean, and no impacts on 

human health are expected.

4.5.1.2 Preferred Alternative: Human Health 

Under the Preferred Alternative, a determination of nonregulated status of DAS-81419-2

soybean by APHIS would not result in any negative impacts to human health when compared to 

the No Action Alternative. DAS-81419-2 soybean is compositionally equivalent to currently 

available soybeans on the market with the exception of Cry1Ac, Cry1F, and PAT protein 

expression (12-272-01p a2, Section 6, 7, 8). As discussed in Section 1.2, Bt corn and Bt cotton 

expressing variations of Cry1Ac or Cry1F have been cultivated for commercial use in the U.S. 

and other countries for more than a decade. Exemptions from tolerance have been established 

based on safety assessments demonstrating a lack of allergenicity and toxicity to mammals.

APHIS considers the voluntary FDA regulatory assessment in making its determination of the 

potential impacts of a determination on nonregulated status of the new agricultural product. 

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DAS initiated the consultation process with FDA for the DAS-81419-2 soybean and submitted a 

safety and nutritional assessment of food and feed derived from DAS-81419-2 soybean to the 

FDA on October 15, 2012. On February 7, 2014, FDA concluded that it had no further questions 

about the use of DAS-81419-2 in food or feed (BNF-000140).

The FDA previously reviewed safety data for the Cry1Ac and Cry1F proteins as present in event 

DAS-21023-5 x DAS-24236-5 (WideStrike® cotton: BNF 0092; BNF 0085) regarding:

Applications and uses; 

Source, identity, and function of the introduced genetic materials; 

The intended effect of the modifications; 

The compositional and nutritional equivalence of the GE lines and their non-GE

counterparts. 

Following completion of the consultation processes and their data reviews, CFSAN confirmed 

that they had no further questions (FDA, 2004a; FDA, 2004b). 

DAS-81419-2 soybean is compositionally equivalent to currently available soybeans on the 

market with the exception of Cry1Ac, Cry1F, and PAT protein expression (see petition12-272-

01p a2, Section 7). The amino acid sequences of both the Cry1Ac and Cry 1F protein expressed 

in DAS-81419-2 soybean are identical to those expressed in WideStrike® Cotton (see petition 

12-272-01p a2).

A biotechnology consultation on the PAT protein was conducted in 1998 and does not require 

additional evaluation by the FDA (FDA, 1998b; FDA, 1998c). 

Based on compositional equivalency to conventional soybean and the safety assessment of the 

expressed proteins, there is no expected change or impact to human health and safety from a 

determination of nonregulated status of DAS-81419-2 as compared to the No Action Alternative. 

4.6 Animal Feed 

The majority of the soybean cultivated in the U.S. is grown for animal feed, and is usually fed as 

soybean meal (Soyatech, 2012). Animal agriculture consumes 98% of the U.S. soybean meal 

produced (Soyatech, 2012). Under FFDCA, it is the responsibility of feed manufacturers to 

ensure that the products they market are safe and properly labeled. Feed derived from DAS81419-2 soybean must be in compliance with all applicable legal and regulatory requirements. 

GE organisms for feed typically undertake a voluntary consultation process with the FDA prior 

to release onto the market. 

DAS submitted a summary of its safety and nutritional assessment of DAS-81419-2 soybean to 

FDA on October 15, 2012. DAS has provided the FDA with information on the identity, 

function, and characterization of the genes, including expression of the gene products in DAS81419-2 soybean. On February 7, 2014, FDA concluded that it had no further questions about 

use of DAS-81419-2 in food or feed (BNF-000140). Additionally, EPA tolerance exemptions 

are already in place for Cry1Ac in all crops and Cry1F in corn and cotton (40 CFR §174.510; 40 

CFR §174.504; 40 CFR §174.520). DAS has submitted an exemption from tolerance for Cry1F 

in soybeans, including toxicology and allergenicity data on the Cry1F protein. The tolerance was 

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published in the Federal Register (v 29, pp 8293-8295, February 12, 2014 ). EPA exemptions 

from a tolerance apply to both food and feed.

DAS analyzed the composition of forage and seed from DAS-81419-2 soybean and compared it 

to a non-GE soybean control variety, Maverick, which has a genetic background similar to DAS81419-2 soybean. DAS also evaluated the composition of forage and seed from six commercial 

non-GE soybean varieties ("reference varieties") grown under the same field conditions as DAS81419-2 soybean and control soybeans. Samples were analyzed for nutrient and anti-nutrient 

content, and the results compared to values reported in scientific literature. The data demonstrate 

compositional equivalence to conventional soybean.

4.6.1.1 No Action Alternative: Animal Feed 

Under the No Action Alternative, DAS-81419-2 soybean would continue to be regulated by 

USDA and EPA. There would be no commercial scale planting of DAS-81419-2 soybean in the 

U.S. and DAS-81419-2 soybean would have limited use in animal feed. No additional risks or 

benefits to livestock feed safety from DAS-81419-2 soybean are expected under the No Action 

Alternative. 

4.6.1.2 Preferred Alternative: Animal Feed 

While planting of DAS-81419-2 soybean under this alternative would not be regulated by 

APHIS, impacts will be unchanged from the No Action Alternative. The safety of the Cry1F, 

Cry1Ac, and PAT proteins as expressed in GE crops is well established; deregulation of DAS81419-2 soybean would not result in novel animal exposure to these proteins, since have been 

similarly present in both commercial corn and cotton plant parts or products. Additionally, 

DAS-81419-2 soybean demonstrates compositional equivalence to conventional soybean. 

Based on the information presented above, a determination of nonregulated status of DAS81419-2 soybean will have no negative impacts on animal feed or animal health. Overall 

impacts are unchanged from the No Action Alternative. 

4.7 Socioeconomic Impacts

4.7.1 Domestic Economic Environment 

GE soybeans are cultivated on 93% of the U.S. soybean acreage as earlier noted in Section 2. 

The U.S. acreage of soybeans planted has varied over time, but the USDA has noted that the 

acreage dedicated to soybean has declined in recent years as returns on investment favored corn 

production (USDA-ERS, 2008). Although acreage has declined, the yield per acre has continued 

to increase (USDA-ERS, 2008). 

4.7.1.1 No Action Alternative: Domestic Economic Environment 

Under the No Action Alternative, DAS-81419-2 would continue to be regulated by APHIS under 

7 C.F.R. Part 340, with limited acreage under EPA registration. The product developer would 

not produce commercial seed. Accordingly, there would be no effect on the U.S. domestic 

soybean market under this alternative. 

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4.7.1.2 Preferred Alternative: Domestic Economic Environment 

Under this alternative, DAS-81419-2 soybean would not be regulated by APHIS. Under the 

EPA registration for seed increase, less than 250,000 acres of DAS-81419-2 soybean would be 

expected to be produced, and most of this would not enter the domestic soybean market. 

In 2012, 93% of soybeans planted were herbicide resistant (USDA-NASS 2012b). DAS-81419-

2 soybean is expected to replace existing soybean acres in areas where lepidopteran pest pressure 

exceeds economic thresholds, if DAS decides to fully register the variety for commercial 

production. DAS studies demonstrate agronomic and compositional equivalence of DAS-81419-

2 soybean to commercially available soybean varieties. Given the equivalence of DAS-81419-2

soybean to herbicide resistant commercial soybean, and the expectation of no new soybean 

acreage, impacts from a determination of non-regulated status are the same as for the No Action 

Alternative.

4.7.2 Trade Economic Environment 

The U.S. produces approximately 35% of the global soybean supply (Soy Stats, 2011, 

Introduction). In 2010, the U.S. exported 1.6 billion bushels of soybean, which accounted for 44 

percent of the world’s soybean exports (The American Soybean Association, 2012a). China is 

expected to account for nearly 80 percent of the increased demand (USDA ERS, 2012c). China 

and India are predicted to import 46 percent of the total soybean market by 2018/2019 (Food and 

Agricultural Policy Research Institute, 2009). The USDA has predicted that U.S. exports will 

remain flat during much of this period, as a result of an increase in domestic consumption and 

competition from South America (Food and Agricultural Policy Research Institute, 2009; USDA 

ERS, 2012c).

The majority of exported soybean seed for planting is sold to other countries in North America, 

with only about 2 percent of this current market (about 1,100 metric tons in 2012) is exported to 

South American countries (USDA-APHIS, 2011a; USDA, 2013) and the five year average 

attains to 700 metric tons (BICO-10 FAS converted data) (USDA-FAS, 2013).

4.7.2.1 No Action Alternative: Trade Economic Environment 

Under this alternative DAS-81419-2 soybean would remain a regulated article by APHIS. Under 

these restrictions, seed would not be produced for export. Accordingly, there would be no 

impacts to trade under the No Action Alternative.

4.7.2.2 Preferred Alternative: Trade Economic Environment 

Under this alternative, DAS-81419-2 soybean would not be regulated by APHIS. 

DAS-81419-2 soybean was developed for lepidopteran pest control, with primary target markets 

in South America. Increases in exports to South American markets as the result of a 

determination of nonregulated status of DAS-81419-2 soybean are not likely to change the 

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current export amounts to other regions, but could increase the overall export of soybean seed to

South America. The addition of new export markets by DAS-81419-2 soybean to the overall 

soybean seed export market will likely be minor in the near term (USDA-APHIS, 2011a; USDA, 

2013). If all the DAS-81419-seed on the 250k acres requested of EPA for seed increase and 

production were sold to South America markets, 272,800 metric tons of seed would be produced

(assuming average US production, 43bu soybean/acre, and 39.5bu equivalency to one ton), 

which would be considerably higher than the present total exports to that region (Table 4). Total 

world exports of US seed for soybean planting were 28,700 tons in 2012 (USDA-FAS (USDAFAS, 2014).

Table 4. Metric Tons of US Seed for Planting Exported to South America (Jan-Dec) by Year

2008 2009 2010 2011 2012

 520 1,058 372 384 1,172

From: USDA-FAS 2014. 

Beginning in 2012, DAS intends to submit dossiers to the regulatory authorities of trade partners 

for import clearance and production approval. This may include Canada, Japan, Korea, Taiwan, 

European Union, Australia/New Zealand, South Africa, Brazil, Argentina and Mexico. DAS 

intends to submit for regulatory approval in South America for import and planting of DAS81419-2 soybean in 2013. Argentina and Chile, the countries that currently import the most 

soybean seed for planting, have not yet approved DAS-81419-2 soybean. Because DAS-81419-

2 soybean represents such a small portion of the total soybean seed production in the U.S., it will 

not impact the availability of other seed varieties that meet the current export needs. 

Under the restrictions of a seed increase registration, DAS-81419-2 soybean is not expected to 

impact trade. Accordingly, impacts to trade economic environment under the No Action 

Alternative will be similar to the No Action alternative.

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5 CUMULATIVE IMPACTS 

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

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

future actions. For example, the potential effects associated with approval of nonregulated status 

for a GE crop in combination with the future production of crop seeds with multiple approved 

traits (i.e., “stacked” traits), including drought tolerance, herbicide resistance, and pest resistance, 

would be considered a cumulative impact. 

5.1 Assumptions Used for Cumulative Impacts Analysis 

DAS has applied for a Section 3 seed increase registration with U.S. EPA for DAS-81419-2 

soybean and a registration was granted January 20,, 2014). The application and subsequent 

registration did not include commercial registration. While DAS-81419-2 soybean was 

developed for use in South America, lepidopteran pest pressure in the U.S. may demonstrate a 

need for DAS-81519-2. Accordingly, the cumulative impacts analysis includes the possibility 

that DAS will commercialize DAS-81419-2 soybean in the future. Before selling DAS-81419-2 

seed in the U.S., DAS would be required to obtain from EPA a FIFRA Section 3 registration for

commercial planting. In that document, EPA will announce data requirements, including the 

need for an Insect Resistance Monitoring program. For example, requirements for Bt corn and 

cotton are set forth in the 2001 BRAD for Bt-PIPs; requirements for Bt soybean are set forth in 

the 2011 BRAD for Mon 87701 (EPA, 2001; EPA, 2011a). 

GE soybeans currently are planted on the majority of soybean acres in the U.S; 93% of soybean 

acres in 2012 were planted to GE varieties, and all which are herbicide resistant. (USDA ERS, 

2012g). The use of herbicide resistant soybean systems is the most common method in the U.S. 

for management of weeds in soybean fields. DAS has plans to cross DAS-81419-2 soybean with 

other deregulated herbicide resistant soybean varieties, such as those expressing glyphosate

tolerance. Therefore, the possibility of stacked traits is presented in the cumulative impacts 

analysis. 

Nonregulated GE glyphosate-resistant (e.g., Roundup Ready®) crop varieties have been in the

market since 1996, when glyphosate-resistant soybean became commercially available. Potential 

effects from cultivation of glyphosate-resistant crops and corresponding regarding implications 

of the use of glyphosate have been thoroughly evaluated in other APHIS Environmental 

Assessments since the 1993 introduction of the first glyphosate-resistant crop product (see

http://www.aphis.usda.gov/biotechnology/not_reg.html).

DAS-81419-2 soybean expresses PAT, which provides resistance to glufosinate ammonium. 

Glufosinate ammonium is registered with EPA for use on soybeans. Thus, there is a potential for

increased glufosinate ammonium use resulting from commercial production of DAS-81419-2 

soybean. 

5.2 Cumulative Impacts: Acreage and Area of Soybean Production 

No cumulative impacts to acreage and area of soybean production are expected under the 

Preferred Alternative, where DAS-81419-2 soybean will be limited to breeding and seed increase 

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activities. Should DAS pursue commercial registration, DAS-81419-2 soybean is expected to 

replace existing GE soybean acres, with adoption likely limited to areas under economically 

significant lepidopteran pest pressure. Projecting possible modest increases in the existing 

populations of pest Lepidoptera, the area of cultivation could eventually include Georgia and

Louisiana where the total acres treated for Lepidoptera already has reached 40-50%. In other 

Southern and possibly some Midwestern states, these pest populations may not attain greater 

importance. The two states (Georgia and Louisiana) encompass together less than 1.8% of total 

planted soybean acres in the U.S. Replacement of existing soybean acres with DAS-81419 would 

be likely, not addition of new acres that were not previously used for soybean production. Thus, 

no cumulative impacts to acreage are expected under potential future commercialization of DAS81419-2 soybean. 

DAS-81419-2 soybean may be conventionally crossed with other GE soybean varieties that are 

not regulated pursuant to Part 340 and the Plant Protection Act. Because 93% of soybeans 

grown in the U.S. today are already herbicide-resistant, crossing of DAS-81419-2 with an 

herbicide resistant soybean variety is not expected to expand the range or change land use 

patterns for soybean cultivation in the U.S. Like other commercial varieties, DAS-81419-2

soybean is a domesticated crop that will not likely be cultivated outside areas of current 

agronomic management where soil and climate conditions are optimal. The addition of 

glyphosate herbicide resistance to DAS-81419-2 soybean would not expand the potential area of 

cultivation. Additionally, displacement of all currently adopted soybean varieties by DAS81419-2 soybean and any progeny is unlikely. 

Because of the high adoption rate of herbicide resistant soybeans already in the market place, and 

the agronomic equivalence between DAS-81419-2 soybean and other commercial varieties, 

commercial production of DAS-81419-2 soybean alone or stacked with other herbicide resistant

varieties will not result in increased adoption of herbicide resistant soybean in the U.S. The 

cumulative effect on land use is expected to be minimal. Impacts are further minimized because 

adoption is expected only in areas experiencing significant lepidopteran pest pressure.

5.3 Cumulative Impacts: Agronomic Practices 

No cumulative impacts on agronomic practices are expected from determining non-regulated 

status for DAS-81419-2 soybean. Potential approval of DAS-81419-2 soybean under a 

commercial use registration by EPA or the generation of soybean varieties stacked with a 

commercially approved DAS-81419-2 soybean and herbicide resistant events are not expected to 

result in any cumulative effects on soybean agronomic practices. 

Herbicides have been the primary tactic used to manage weed communities in soybeans since the 

mid-1960s and will continue to be an important feature of row crop weed management for the 

foreseeable future. Glyphosate has become the most often-used herbicide on U.S. soybean: in 

2006, nearly 92 million pounds of glyphosate were applied on 92% of the planted acres (USDA 

NASS, 2007b). Prior to 1995, glyphosate was primarily used for pre-plant weed control in 

soybean (Young, 2006). After 1995, annual glyphosate usage increased due to post-emergence 

application on Monsanto’s Roundup Ready® Soybean (GTS 40-3-2) which became 

commercially available to growers in 1996. In 2006, an estimated 98 percent of the planted 

soybeans were treated with at least one type of herbicide (USDA NASS, 2007b). It is common 

practice today for growers to make use of herbicide resistance in soybeans, particularly 

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glyphosate resistance. No changes in current agronomic practices would be required if DAS891419-2 were to be stacked with a deregulated glyphosate resistance trait.

Commercial plans for DAS 81419 soybean are at present confined to seed production on less 

than 250,000 acres in the US (Dow-Agrosciences, 2013) and that seed will be mostly exported. 

No commercial use can be made of the variety unless EPA has issued a permit for unrestricted 

commercial sale of the variety and for various stacks or combinations of traits including DAS81419-2 that are licensed for that stack. As noted however, seed production could reach 0.3% of 

total acreage of all planted soybean acres. Use of glufosinate is not anticipated on these seed 

production acres, but overall use of glufosinate may increase should the variety be offered for 

commercial commodity soybean production. Glufosinate will likely be used when incorporated 

into widely sold glyphosate resistant soybean varieties if growers have no economical 

alternatives for control of glyphosate resistant weeds, and primarily if the trait for glyphosate 

resistance becomes in some measure ineffective. While glyphosate remains highly effective on a 

broad range of weeds, has flexibility in application windows, and is more economical than many 

herbicides, it will continue to be a high use herbicide. Glufosinate will be used where glyphosate 

resistant weeds are prevalent, but will not likely attain to the usage rate of glyphosate for the 

reasons noted.

If DAS-81419-2 soybean is commercialized in the U.S. market, growers in soybean areas 

experiencing high lepidopteran pest pressure may choose to adopt DAS-81419-2 soybean, 

possibly reducing insecticide applications in these fields. It is expected that growers will still 

monitor fields for insect damage and apply other insecticides, due to the presence of soybean 

insect pests not affected by Cry1Ac and Cry1F. Therefore, the only anticipated change in 

current agronomic practices for insect control with commercialization of DAS-81419-2 is the 

potential reduction of insecticide applications for specific lepidopteran pests. As pest pressure 

varies across regions, no cumulative impacts to agronomic practices from adoption of DAS81419-2 soybean is expected.

An estimate of the potential market for this lepidopteran resistant product is bounded by the 

likely number of acres for which present lepidopteran pest levels are highest. At present, these 

acres are apparently not sufficient to justify producing and marketing the product in the US for 

commercial soybean production. As noted in the Affected Area discussion, about 50% of the 

soybean acreage in Georgia and 40% of that in Louisiana are treated for lepidopteran pests with 

conventional insecticides. The other areas of the US where soybeans are planted at present have

not received the same level of lepidopteran infestation that would consistently require an insect 

resistant soybean. If all the soybean acres presently receiving insecticides (for any insect pest) 

would be planted to a Cry-expressing soybean for lepidopteran resistance, the total IR soybean 

would be as much as 40% of US soybean acres (USDA-NASS, 2013e). Of course, the total need 

for lepidopteran control would be much less because the USDA data is for control of all insect

pests. Stinkbugs and beetles are the most important pests in Southeastern and Northeastern farms

respectively, while Midwestern farms generally see economically important damage from 

soybean aphids, and do not have economically important lepidopteran populations on soybean. 

The USDA data is also listed by insecticide used, so multiple applications of different 

insecticides to the same field and which insects were primary targets could not be discerned from 

the application data. 

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Besides the value of the insect resistance trait, commercial soybean growers may also consider 

the usefulness of the glufosinate trait. Glufosinate would likely be an adjunct soybean resistance 

that would be used if glyphosate resistant weeds were present in the soybean fields. Thus, a 

glufosinate resistance trait would augment the control potential for glyphosate, but only when 

growers needed the variety’s IR trait for locally important lepidopteran pests. Heap (Heap, 

2013) estimates that in the U.S., 6 million hectares have glyphosate resistant weeds (14.83 

million acres) and if these were found predominately in the soybean and corn production areas, 

would represent about 9% of all acres on which soybean might be grown. A survey from 2012 

indicates that the total land with glyphosate resistant weeds may have reached 61.2 million acres; 

Georgia growers have an infestation on 92% of their acres (Stratus-Agri-Marketing, 2013). 

Consequently, 9-40% of soybean production land (corn-planted acres plus soybean-planted acres 

together total 168 million acres) may potentially have glyphosate resistant weeds. If the 

potential need for an IR (insect resistant) soybean (assume 15% of acres) were considered as a 

subset of those that may also need an herbicide mode of action such as glufosinate to control 

glyphosate resistant weeds (9-40% of acres), then the product of the two represents the possible

market penetration; 1.35-6% would be a general estimate of the possible adoption of the product. 

The market penetration could be larger if the general pest status of the various lepidopterous 

pests of soybean were to markedly increase beyond the two state area so that a higher percentage 

of growers would have an economic reason to request and plant a commodity soybean variety 

with such lepidopteran pest resistance traits.

Although glufosinate resistant varieties are at least one strategy for control of glyphosate 

resistant weeds in soybeans, other herbicide regimes can also be used, either with glyphosate use 

or without (Hager, 2013; Monsanto, 2013). Considering that lepidopteran resistance traits might 

be needed in the cited areas, and that glufosinate also were needed in only some of the 

glyphosate weed resistant acres, a minimal adoption might be even less than 1-6% of total 

soybean acres. The total impact of the crop, should it be commercialized, would not be a 

substantial number of acres.

5.4 Cumulative Impacts: Soybean Seed Production

No cumulative impacts on production of soybean seed are expected following a determination of 

non-regulated status for DAS-81419-2 soybean. Based on current trends, GE soybean are likely 

to continue to dominate soybean production. GE soybean varieties were grown on more than 

93% of soybean acres in 2012. 

Should DAS-81419-2 soybean become commercially available, no change in U.S. soybean 

cultivation and seed production is expected. The percentage of soybean seed exports for planting 

is presently small and growth of seed production would not be large compared to soybean 

commodity production (Section 4.7.2). Since high value soybean production areas are likely 

already used for commercial production, any new seed production is likely to use these existing 

acres, especially since growers would receive a premium for soybean seed production compared 

to commercial production. 

Potential commercialization of DAS-81419-2 soybean is not expected to create new acres for 

seed production. If growers see value in the traits offered by a DAS-81419-2 soybean or stacked 

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progeny, this variety may replace existing soybean varieties. Because changes in the agronomic 

practices or locations for soybean seed production are not expected from potential future 

commercialization of DAS-81419-2 soybean, there are no cumulative effects identified for 

production of either GE or non-GE seed if DAS-81419-2 soybean is commercialized in the U.S. 

Similarly, no cumulative effects are expected upon possible future commercialization of any

stacked progeny of DAS 81419-2 and other non-regulated soybean varieties, such as herbicideresistance, for standard commodity soybean production.

Management practices for the production of high quality seed, such as AOSCA or state standards

for production of soybean seed of the desired class, would continue under the Preferred 

Alternative. These practices further support a finding of no cumulative effects upon deregulation 

and possible future commercialization of 1) DAS 81419-2 soybean; and 2) stacked progeny.

5.5 Cumulative Impacts: Organic Soybean Production

No cumulative impacts to organic soybean production are expected under the Preferred 

Alternative. A determination of nonregulated status of DAS-68416-4 soybean is not expected to 

change the market demands for GE soybean or soybean produced using organic methods. Data 

from USDA-ERS indicates that in 2012, 93% of all soybean grown in the U.S. were herbicideresistant GE varieties (USDA ERS, 2012b). In 2008, organic soybean varieties were grown on 

less 0.2% of soybean acres planted in the U.S; in 2005, the organic soybean market share was 

0.17% (USDA ERS, 2010b). 

Since 1994, nine GE soybean events or lines have been determined by APHIS as no longer 

subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant 

Protection Act. Organic production of soybeans grew from 82,143 acres in 1997 to a maximum 

of 174,467 acres in 2001 (USDA ERS, 2010b). Since 2001, the total acreage of organic soybean 

production has experienced a slight decline in growth over time, with 125,621 acres planted in 

2008 (USDA ERS, 2010b). The decline of organic soybean acreage has been attributed to high 

prices being paid for conventional soybean and high fuel costs (McBride and Greene, 2008), not 

the adoption rate of GE soybean. Based on the trend in the cultivation of GE soybean, non-GE,

and organic soybean varieties, and the expectation that corresponding production systems to 

preserve varietal integrity are both likely to remain the same, no cumulative impacts are expected 

in the event of commercial production of 1) DAS-81419-2 soybean; nor 2) any stacked progeny.

5.6 Cumulative Impacts: Water Resources 

Approval of DAS petition for deregulation and potential commercial production in the U.S. of 

DAS-81419-2 soybean for seed is not expected to have cumulative impacts on water resources. 

Generation of stacked herbicide resistant varieties from DAS-81419-2 soybean and other 

herbicide resistant soybean varieties is also not expected to have a cumulative effect on water 

resources. Use of herbicides on DAS-81419-2 soybean either 1) alone or 2) stacked with other

traits such as herbicide resistance is not expected to increase the overall number of acres where 

herbicide would be applied. Herbicide resistant soybeans currently comprise 93% of U.S. 

soybean varieties produced (USDA ERS, 2012b). DAS-81419-2 soybean, either alone or 

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stacked with other traits, would likely replace to a limited extent currently cultivated herbicide 

resistant soybeans. 

Acceptability of herbicide accumulation in water is the responsibility of EPA to assess, and the 

potential of impacts of commercially available herbicides have been examined by EPA. 

Glyphosate is already used on soybean in both conventional and GE varieties and the impacts of 

glyphosate use on water resources are well documented. Although glyphosate is very soluble in 

water, it is strongly adsorbed to soils; consequently, glyphosate is unlikely to leach into 

groundwater or surface water runoff following application (EPA, 1993; Giesy et al., 2000).

Relying on toxicological data, bioaccumulation and biodegradation studies, and acute and 

chronic tests on fish and other aquatic organisms, EPA has determined that “the potential for 

environmental effects of glyphosate in surface water is minimal” (EPA, 2002b). 

Glufosinate ammonium is weakly adsorbed and highly mobile in soil, rapidly degrading in soil 

and water and having a short soil residual half-life of seven days (WSSA, 2007). Glufosinate 

ammonium has a high leaching potential in soil, but because it degrades so rapidly, it is rarely 

found deeper than 15 centimeters (approximately 6 inches) from the soil surface (WSSA, 2007), 

and thus has little potential impact to groundwater. Implementation of best management 

practices to slow soil erosion and filter pollutants from surface runoff, such as vegetated strips, 

control of spray drift, and adherence to label restrictions governing safe application and 

equipment cleanup, minimize the potential for pesticide impacts to surface and groundwater.

There may be potential reduction in insecticide use in areas where DAS-81419-2 soybean or 

stacked progeny is adopted. As current insecticide applications to soybean are few, any change 

is expected to be small. Overall, there are no cumulative effects on water resources from 

deregulation and possible commercial production of: 1) DAS-81419-2 soybean; or 2) any 

progeny of DAS-81419-2 soybean stacked with other traits such as herbicide resistance.

5.7 Cumulative Impacts: Soil Quality 

No cumulative impacts to soil quality are expected under the Preferred Alternative. Due to the 

lack of economically significant lepidopteran insect pressure, DAS-81419-2 soybean is unlikely 

to replace large amounts of currently planted GE soybean varieties across U.S. cultivation areas. 

Similarly the use of tillage, agriculture equipment, irrigation, and fertilizer applications would 

not likely change as a result of a determination of nonregulated status (Section 4.2.2). 

Commercial production of DAS-81419-2 soybean in the U.S. is not expected to contribute to 

increases of soil loss or degradation in comparison to the No Action Alternative, thus there are 

no expected cumulative impacts to soil quality upon potential commercialization of DAS-81419-

2 soybean. 

Safety and use profiles for glyphosate and glufosinate are well documented (EPA, 2002b; USEPA, 2013). Therefore, no cumulative effects on soil quality are expected from 

commercialization of any stacked progeny of DAS-81419-2 soybean.

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5.8 Cumulative Impacts: Air Quality 

There are no expected cumulative impacts on air quality resulting from a determination of 

nonregulated status for DAS-81419-2 soybean. In the event of product commercialization, 

adoption of DAS-81419-2 soybean across the entire U.S. soybean cultivation range is unlikely

because adoption is expected only in areas where lepidopteran insect pressure reaches economic 

levels. While adoption could result in fewer insecticide applications in these areas, any change is 

not expected to impact air quality: insect pressure from non-lepidopteran pests may still require 

insecticide applications, and insect pressure varies by year and location. Currently, insecticides 

are applied to a small percentage of soybean acres, so the overall change in insecticide 

applications is expected to be small. 

DAS-81419-2 soybean expresses resistance to glufosinate ammonium. Glufosinate ammonium 

has low volatility and a short soil residual life (average half-life of 7 days) (WSSA, 2007); thus, 

it is not considered an atmospheric contaminant with any potential impacts to air quality. 

Combining the DAS-81419-2 soybean event with a nonregulated herbicide resistant trait such as 

glyphosate enables continued adoption and use of reduced- or no till strategies in soybean 

cultivation. Therefore, there are also no anticipated negative cumulative effects on air quality 

from U.S. commercialization of DAS-81419-2 soybean nor from any stacked progeny.

5.9 Cumulative Impacts: Climate Change 

Nonregulated status of DAS-81419-2 soybean is not expected to result in any cumulative 

impacts on climate change. While some agricultural practices can contribute to climate change 

through greenhouse gas emissions, these will not change as a result of a determination of 

nonregulated status of DAS-81419-2 soybeans. Accordingly, potential commercialization of 

DAS-81419-2 soybean is unlikely to result in cumulative impacts on climate change. Similarly, 

if DAS-81419-2 soybean were stacked with other nonregulated soybean varieties, such as 

herbicide resistant varieties, cumulative impacts are also unlikely.

5.10 Cumulative Impacts: Animal Communities 

No cumulative impacts to animal communities are expected under the Approval the Petition 

Alternative. DAS-81419-2 soybean is not toxic to vertebrate animals. Cry1F and Cry1Ac, are 

specific to certain lepidopteran species: caterpillars that eat plants expressing the proteins 

typically die (Pigott and Ellar, 2007; British Columbia Ministry of Environment, 2012). Other 

orders of insects are not affected by the Cry1F and Cry1Ac toxins and thus would not be affected 

by DAS-81419-2 soybean. Cry proteins are naturally occurring, and present in common, nonpathogenic soil bacteria. Cry1Ac and Cry1F are also expressed in commercially available corn 

and cotton products, either alone or in combination with other insecticidal proteins (EPA, 2001; 

Mendelsohn et al., 2003; EPA, 2008a; EPA, 2010a). There have been no impacts on nontarget 

insects from WideStrike cotton which also expresses both IR Bt traits of DAS-81419-2 soybean 

but instead in cotton varieties.

Should DAS-81419-2 soybean be commercialized, growers that consistently use insecticides to 

control lepidopteran pests in soybeans are the most likely to adopt DAS-81419-2 soybean. In 

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cotton growing areas, DAS-81419-2 soybeans could increase the acreage of crops expressing 

Cry1Ac and Cry1F. Insect populations that feed on both cotton and soy could experience greater 

exposure, resulting in a possible reduction in the target lepidopteran pest populations. Though 

adoption of DAS-81419-2 soybean may increase exposure of animals to Cry1Ac and Cry1F in 

the environment, vertebrate animals are not affected by the Cry proteins. Thus, the change in 

exposure will not impact animals. 

Non-target invertebrates could also experience greater exposure to the Cry1Ac and Cry1F 

endotoxins. However, as described in Section 4.4.1, non-target invertebrate populations are not 

likely to be affected by Cry1 endotoxins. The increase in exposure would not change the effects 

on these populations compared to the current situation. 

Commercial production of DAS-81419-2 soybean would require registration under Section 3 of 

FIFRA, under EPA jurisdiction. EPA data requirements for registration would include 

implementation of an Insect Resistance Management Program (IRM). The 2001 Biopesticides 

Registration Action Document (BRAD) for Bt Plant Incorporated Protectants (PIP) sets forth 

requirements for an IRM plan (EPA, 2001). The BRAD for Monsanto’s IR soybean (expressing 

Cry1Ac) states that information on pest biology, dose, simulation modeling, and cross resistance 

would be required to assess the risks for an unlimited commercial registration (EPA, 2011a). 

DAS must satisfy EPA requirements prior to undertaking commercial production. In particular, 

should DAS submit for and obtain full commercial cultivation registration of DAS-81419-2 

soybean from EPA, widespread adoption of the product may reduce the current natural refuge for 

lepidopteran pests of cotton. Any future action to change the area where DAS-81419-2 soybean 

is EPA registered to be grown would take into account the other Bt crops in the area as well as 

any natural refuge in designing an IRM plan. DAS submitted a proposal to the EPA to allow seed 

production on small acreages without refuges, whose size is determined by proximity to other 

soybean, and to cotton acreage, where targeted insects are likely to be present. The proposal was 

accepted by (US-EPA, 2013e).

Use of herbicides on DAS-81419-2 soybean alone or stacked with other traits is not expected to 

increase the overall number of acres receiving herbicide treatment. Ninety-three percent of 

soybean acres are herbicide resistant (USDA NASS, 2012b); it is reasonable to assume that 

nearly all receive herbicide treatments. Any herbicides applied to DAS-81419-2 soybean or 

progeny would be used in accordance with per-application and per-year rates approved by EPA. 

While there is a possibility of increased glufosinate ammonium use upon adoption of DAS81419-2 soybean, no impacts from potential use are expected. 

On an acute exposure basis, glufosinate is considered practically nontoxic to birds, mammals, 

and insects; slightly non-toxic to freshwater fish; slightly toxic to estuarine/marine fish; 

moderately toxic to freshwater and estuarine/marine invertebrates; and toxic to terrestrial and 

aquatic plants. For birds, glufosinate is practically non-toxic on an acute and subacute dietary 

basis; therefore, the risk potential is presumed to be low (EPA, 2008b).

Glyphosate is already in use in soybean in both conventional and Roundup Ready varieties. The 

herbicide has been previously reviewed by EPA for impacts on non-target organisms and is 

currently being evaluated as part of the reregistration review process, scheduled to be completed 

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in 2015 (EPA, 2009b). EPA’s process ensures that each registered pesticide continues to meet 

the highest standards of safety to protect human health and the environment

5.11 Cumulative Impacts: Plant Communities 

No cumulative impacts to plant communities are expected upon determination of nonregulated 

status of DAS-81419-2 soybean. Except for expression of the Cry1Ac, Cry1F, and PAT 

proteins, DAS-81419-2 soybean is agronomical and compositionally equivalent to commercially 

available varieties (12-272-01p a2, Sections 8.4). The Cry proteins are toxic to certain 

lepidopteran insects, with no effect on plants. Use of herbicides on DAS-81419-2 soybean alone 

or stacked with other herbicide resistant traits is not expected to increase the overall number of 

acres on which herbicide would be applied. Any herbicides applied to DAS-81419-2 soybean or 

stacked varieties would be used in accordance with rates approved by EPA. Therefore, 

commercialization of DAS-81419-2 soybean in the U.S. is not expected to have any cumulative 

impacts on plants. Commercial production of any stacked progeny of DAS 81419-2 soybean,

such as herbicide tolerant stacked progeny, is also not expected to result in any cumulative 

impacts for the reasons described above. 

5.12 Cumulative Impacts: Gene Flow and Weediness 

No cumulative impacts on gene flow and weediness are expected from a determination of 

nonregulated status for DAS-81419-2 soybean. Agronomic characteristics of DAS-81419-2 

soybean are substantially equivalent to other GE and non-GE varieties (Petition, Section 8). 

Given the reproductive characteristics of soybean, the probability for cross-pollination is low 

(Caviness, 1966; Ray et al., 2003). Additionally, the soybean industry has identity protection 

measures in place to restrict pollen movement and gene flow between soybean fields through the 

use of isolation distances, border and barrier rows, the staggering of planting dates and various 

seed handling and transportation procedures (Sundstrom et al., 2002; NCAT, 2003; Bradford, 

2006). Under both the No Action and Preferred Alternatives, DAS-81419-2 soybean will be 

grown using these practices. 

There is no evidence that horizontal gene transfer and expression of DNA occurs between 

soybean and soil bacteria or unrelated plant species under natural field conditions (see Section 

2.3.3). Due to its agronomic equivalence to other soybean varieties, there is no greater potential 

for gene movement between sexually compatible soybean varieties (vertical gene flow) in DAS81419-2 soybean compared to other non-GE or GE cultivars. Accordingly, no cumulative 

impacts on gene flow or weediness are expected from potential commercialization of: 1) DAS81419-2 soybean; or 2) stacked progeny of DAS-81419-2 soybean with other nonregulated GE 

soybean events. 

5.13 Cumulative Impacts: Microorganisms 

No cumulative impacts to microorganisms are expected under the Preferred Alternative. Bt from 

root exudates occurs in soils where GE Bt crops are planted; these exudates do not affect soil 

quality (see Section 4.3.2). Regarding potential future commercialization in the U.S., use of 

herbicides on 1) DAS-81419-2 soybean or 2) DAS-81418-2 progeny stacked with other traits is 

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not expected to increase the overall number of acres receiving herbicide treatment. Herbicide 

resistant soybeans currently comprise 93% of U.S. soybean cultivars (USDA-ERS, 2012b).

DAS-81419-2 soybean, either alone or stacked with other traits such as glyphosate resistance,

would likely replace herbicide resistant soybeans currently cultivated. 

As soybean is often rotated with other crops, rotation of Bt soybean with another Bt crop, such as 

corn, is possible. Bt is a ubiquitous, naturally occurring soil bacterium, with no negative effects 

on soil microbes (see Section 4.3.2). Therefore, the production of DAS-81419-2 soybean, even 

in rotation with other Bt crops, will not cumulatively impact soil quality or microorganisms. 

Glufosinate ammonium is rapidly degraded in soil, acted upon by microbes that degrade it to 

CO2 and natural phosphorus compounds (EPA, 2008b). Studies of the effects of glufosinate 

ammonium on the microbial community have yielded varying results: several found no 

differences in the microbial community from the application of glufosinate ammonium compared 

to either those treated with different herbicides or those left untreated (Schmalenberger and 

Tebbe, 2002; Lupwayi et al., 2004; Wibawa et al., 2010). However, Gyamfi et al. found the 

application of glufosinate ammonium caused minor, transient shifts in the bacterial community 

structure, potentially caused by the increase of herbicide-degrading microbes (Gyamfi et al., 

2002). Other research found that the use of glufosinate ammonium inhibits the activity of 

cultivar pathogens such as Bacterial Blight (Pline, 1999) and Grapevine Downy Mildew 

(Plasmopara viticola) (Albrecht and Kortekamp, 2009). 

Glufosinate ammonium is currently registered by EPA for use on soybeans; thus use could 

increase by grower adoption of DAS-81419-2 soybeans. 

For the reasons described above no cumulative impacts on soil microbes are expected upon 

potential future commercialization of 1) DAS-81419-2 soybean; or 2) stacked progeny of DAS81419-2 soybean containing other non-regulated GE traits, such as herbicide resistance.

5.14 Cumulative Impacts: Biodiversity 

Under the Preferred Alternative, no cumulative impacts to biodiversity are expected. 

DAS-81419-2 soybean is similar in all respects to other soybeans except for the expression of 

Cry1Ac, Cry1F, and PAT. Cry proteins demonstrate high specificity and toxicity to certain 

lepidopteran insects, are naturally occurring in soil bacteria, and present in other commercially 

available crops (see Section 4). Bt crops have been cultivated since 1996; the lack of adverse 

impacts on biodiversity is well documented in the scientific literature (see, e.g., Sections 4.4; 

4.5). 

A determination of non-regulated status and U.S. commercial production of DAS-81419-2 

soybean is not expected to result in new acres upon which herbicides are applied. Ninety-three 

percent of current soybean acres are herbicide resistant, with both glyphosate and glufosinate 

ammonium registered for use on soybeans. For these reasons, no new cumulative impacts to 

biodiversity are expected from deregulation of DAS-81419-2 soybean. Additionally, no 

cumulative impacts are expected upon potential commercialization of 1) DAS-81419-2 soybean 

alone, or 2) any stacked progeny, including progeny containing herbicide resistant traits.

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5.15 Cumulative Impacts: Human Health 

DAS-81419-2 soybean expresses proteins Cry1Ac, Cry1F and PAT. Cry1Ac and Cry1F proteins 

are toxic to certain lepidopteran species; they are not toxic to vertebrate animals, including 

humans, and have no similarities to known allergens (see Section 4.5). Cry1Ac and Cry1F have

an exemption from tolerance from the EPA and are deemed safe for human consumption (EPA, 

2005c). DAS initiated the consultation process with FDA for DAS-81419-2 soybean and 

submitted a safety and nutritional assessment of food and feed derived from DAS-81419-2

soybean to the FDA on October 15, 2012. On February 7, 2014, FDA concluded that it had no 

further questions about use of DAS-81419-2 in food or feed (BNF-000140).

DAS intends to develop a stacked variety with DAS-81419-2 soybean and commercially 

available soybean varieties expressing glyphosate resistance. A major source of glyphosate 

resistance in crops is the CP4 EPSPS protein derived from Agrobacterium spp. As specified in 

40 CFR §174.523, EPA has reviewed the safety of the CP4 EPSPS protein and has established a 

tolerance exemption for the protein and the genetic material necessary for its production in or on 

all raw agricultural commodities (EPA, 2007d) EPA has also determined that the PAT protein 

presents a low probability of risk to human health and the environment and granted an exemption 

from the requirement of a tolerance for this PIP inert ingredient (EPA, 2007b).

Herbicide resistant soybeans account for 93% of U.S. acreage and both glyphosate and 

glufosinate ammonium are registered with the EPA for use on soybeans. Should DAS seek and 

obtain commercial use registration with EPA, it is possible that some growers may apply 

glufosinate to DAS-81419-2 soybean. No overall change in herbicide use patterns is expected if 

DAS-81419-2 soybean is granted nonregulated status. 

For glufosinate ammonium, the 2003 EPA risk assessment based the occupational risk

assessment on the highest supported application rates for cotton, bushberry, and rice (0.79, 0.52 

and 0.44 lb ai/A per application, respectively), which are greater or equal to the approved 

application rate of 0.44 lb ai/A per application for soybean (EPA, 2008b). This assessment

concluded the modeled exposure levels were adequate for the determination of potential adverse 

human health effects posed by glufosinate ammonium (EPA, 2008b). Potential human health 

effects from glufosinate ammonium use are currently under review in the EPA reregistration 

review process for this herbicide (EPA, 2008b). The current EPA-approved label for glufosinate 

ammonium includes precautions and measures to protect human health. Applications of 

pesticides in accordance with the registered use and label instructions minimize the potential for 

human health impacts. 

For all the reasons described above, no cumulative impacts on human health are expected from a 

determination on non-regulated status of DAS-81419-2 soybean. Similarly, commercialization

of 1) DAS-81419-2 soybean alone; or 2) any stacked progeny of DAS-81419-2 soybean

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containing, for example, herbicide resistance traits, is also expected to have no cumulative 

impacts on human health.

5.16 Cumulative Impacts: Animal Feed 

The Cry1Ac and Cry1F proteins expressed in DAS-81419-2 soybeans are toxic to certain 

lepidopteran species, but not toxic to vertebrate animals, including livestock, and have no 

similarities to known allergens (see Section 4.5). These proteins have an exemption from 

tolerance from the EPA. There are no anticipated effects on livestock health from the 

consumption of this protein. 

Based on previous FDA food and feed assessments of commercial products expressing Cry1Ac 

and Cry1F proteins (FDA, 2004a; FDA, 2004b), DAS-81419-2 soybean is not materially 

different in any respect relevant to feed safety compared to commercially available soybean 

varieties. Thus, no cumulative effects on animal feed are anticipated from a determination of 

non-regulated status for DAS-81419-2 soybean. Further, no cumulative effects are expected 

should DAS commercialize DAS-81419-2 soybean in the U.S.

Regarding a glyphosate resistant stacked variety of DAS 81419-2 soybean, glyphosate has been 

widely used on soybean since 1996. The use of glyphosate herbicide does not appear to result in 

adverse effects on development, reproduction, or endocrine systems in mammals. Under present 

and expected use conditions, and when used in accordance with the EPA label, glyphosate does 

not pose a health risk to animals as an animal feed concern. Pesticide residue tolerances for 

glyphosate are listed in 40 CFR § 180.364 and include acceptable concentrations for soybean 

forage, hay, hulls, and seed (EPA, 2012d). 

Glufosinate ammonium was first registered by EPA for use in crops in 2000 as a non-selective 

foliar herbicide used for pre-plant and post-emergence control of broadleaf weeds (EPA, 2008b). 

It is currently registered for use on many crops including apples, berries, canola, corn, cotton, 

currants, grapes, grass grown for seed, potatoes, rice, soybeans, sugar beets, and tree nuts and for 

use in non-crop areas including lawns and residential areas (EPA, 2008b). GE glufosinate 

resistant soybean treated with glufosinate ammonium must not be grazed or cut for hay (Bayer 

CropScience, 2011). This is a minor use of soybeans and the commercialization of DAS-81419-

2 is not expected to impact this limited use.

Based on the above, no cumulative effects on animal feed are anticipated with regards to 

commercialization of: 1) DAS-81419-2 soybean alone or 2) any stacked progeny, including 

progeny containing herbicide resistance. 

5.17 Cumulative Impacts: Domestic Economic Environment 

For reasons discussed throughout this document, no cumulative impacts to the domestic 

economic environment are expected under the Preferred Alternative. Adoption of DAS-81418-2 

soybean is expected in current soybean growing areas under economically significant pest 

pressure if DAS decides to make it available for commodity soybean production. No new 

soybean acres are expected with commercial production of DAS-81419-2 soybean. The same is 

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true for any stacks of DAS-81419-2 soybean with other commercially available GE soybean

varieties. Accordingly, no cumulative impacts on the domestic economic environment are 

anticipated upon potential commercialization of either: 1) DAS-81419-2 or; 2) any stacked 

progeny. 

5.18 Cumulative Impacts: Trade Economic Environment 

DAS-81419-2 soybean is engineered to control lepidopteran pests of soybeans. These pests are 

more economically important in tropical and semi-tropical areas of the world than in temperate 

climates. The primary market for DAS-81419-2 soybean is currently South America. 

Soybean seed exports for crop cultivation are a minor part of the current soybean export market, 

the vast majority of soybeans are exported for processing (USDA ERS, 2012e; USDA, 2013). 

See also section 2.6.2 of this document. The contribution of DAS-81419-2 soybean to the 

overall soybean export market will not be significant; most soybean seed is exported for 

processing not planting (USDA ERS, 2012e). Any increase in seed exports that may result from 

a determination of nonregulated status of DAS-81419-2 soybean would be small compared to the 

total export commodity soybean market, but would nevertheless represent a major increase in 

seed export shipment. However, no likely impact can be anticipated to the economic 

environment. Similarly, no cumulative impacts to trade economic environment are expected 

from commercial production of either: 1) DAS-81419-2 soybean, or 2) stacked progeny of DAS81419-2 soybean, such as those expressing herbicide resistance traits. Accordingly no 

cumulative impacts on soybean exports are expected from a determination of non-regulated 

status for DAS-81419-2 soybean. 

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6 THREATENED AND ENDANGERED SPECIES 

6.1 Scope of Analysis

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching 

wildlife conservation laws ever enacted by any nation. Congress passed the ESA to prevent 

extinctions facing many species of fish, wildlife and plants. The purpose of the ESA is to 

conserve endangered and threatened species and the ecosystems on which they depend as key 

components of America’s heritage. To implement the ESA, the U.S. Fish & Wildlife Service 

(USFWS) works in cooperation with the National Marine Fisheries Service (NMFS), other 

Federal, State, and local agencies, Tribes, non-governmental organizations, and private citizens. 

Before a plant or animal species can receive the protection provided by the ESA, it must first be 

added to the Federal list of threatened and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be endangered or 

threatened because of any of the following factors:

• The present or threatened destruction, modification, or curtailment of its habitat or 

range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• The inadequacy of existing regulatory mechanisms; and

• The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, protective measures apply to the species and its 

habitat. These measures include protection from adverse effects of federal activities. 

Section 7 (a)(2) of the ESA requires that federal agencies, in consultation with USFWS and/or 

the NMFS, ensure that any action they authorize, fund, or carry out is “not likely to jeopardize 

the continued existence of a listed species or result in the destruction or adverse modification of 

designated critical habitat.” It is the responsibility of the federal agency taking the action to 

assess the effects of their action and to consult with the USFWS and NMFS if it is determined 

that the action “may affect” listed species or designated critical habitat. To facilitate their ESA 

consultation requirements, APHIS met with the USFWS from 1999 to 2003 to discuss factors 

relevant to APHIS’ regulatory authority and effects analysis for petitions for nonregulated status 

and developed a process for conducting an effects determination consistent with the Plant 

Protection Act (PPA) of 2000 (Title IV of Public Law 106-224). APHIS uses this process to 

help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology 

regulatory actions. 

APHIS met with USFWS officials on June 15, 2011, to discuss whether APHIS has any 

obligations under the ESA regarding analyzing the effects of herbicide use associated with all 

GE crops on TES. As a result of these joint discussions, USFWS and APHIS have agreed that it 

is not necessary for APHIS to perform an ESA effects analysis on herbicide use associated with 

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GE crops currently planted because EPA has both regulatory authority over the labeling of 

pesticides and the necessary technical expertise to assess pesticide effects on the environment 

under FIFRA. APHIS has no statutory authority to authorize or regulate the use of glufosinate or 

any other herbicide, by soybean growers. Under APHIS’ current Part 340 regulations, APHIS 

only has the authority to regulate DAS-81419-2 soybean or any GE organism as long as APHIS 

believes they may pose a plant pest risk (7 CFR § 340.1). APHIS has no regulatory jurisdiction 

over any other risks associated with GE organisms including risks resulting from the use of 

herbicides or other pesticides on those organisms. 

After completing a plant pest risk analysis, if APHIS determines that DAS-81419-2 soybean 

seeds, plants, or parts thereof do not pose a plant pest risk, then this article would no longer be 

subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR Part 

340, and therefore, APHIS must reach a determination that this article is no longer regulated. As 

part of its EA analysis, APHIS is analyzing the potential effects of DAS-81419-2 soybean on the 

environment including, as required by the ESA, any potential effects to threatened and 

endangered species and critical habitat. As part of this process, APHIS thoroughly reviews the 

GE product information and data related to the organism (generally a plant species, but may also 

be other genetically engineered organisms). For each transgene/transgenic plant, APHIS 

considers the following: 

• A review of the biology and taxonomy of the crop plant and its sexually compatible 

relatives;

• Characterization of each transgene with respect to its structure and function and the 

nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in 

the plant and their quantity;

• A review of the agronomic performance of the plant, including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impacts;

• Determination of the concentrations of known plant toxicants (if any are known in the 

plant);

• Analysis to determine if the transgenic plant is sexually compatible with any 

threatened or endangered species (TES) of plants or a host of any TES; and

• Any other information that may inform the potential for an organism to pose a plant 

pest risk.

In following this review process, APHIS, as described below, has evaluated the potential effects 

that a determination of nonregulated status of DAS-81419-2 soybean may have, if any, on 

federally-listed TES species and species proposed for listing, as well as designated critical 

habitat and habitat proposed for designation.

Based upon the scope of the EA and production areas identified in the Affected Environment 

section of the EA, APHIS reviewed the USFWS list of TES species (listed and proposed) for 

each state where soybean is commercially produced from the USFWS Environmental 

Conservation Online System (ECOS; as accessed 1-20-2014 at 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp). Prior to this review, 

APHIS considered the potential for DAS-81419-2 soybean to extend the range of soybean 

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production and also the potential to extend agricultural production into new natural areas. This 

product was developed for growers in South America and is not expected to be grown in the 

United States to any great extent. APHIS has determined that agronomic characteristics and 

cultivation practices required for DAS-81419-2 soybean are essentially indistinguishable from 

practices used to grow other soybean varieties, including other herbicide-resistant varieties. 

(Dow-AgroSciences, 2012; USDA-APHIS, 2012b). If grown in the US, DAS-81419-2 soybean 

may be expected to replace other varieties of soybean currently cultivated, and APHIS does not 

expect the cultivation of these to result in new soybean acres to be planted in areas that are not 

already devoted to agriculture. Accordingly, the issues discussed herein focus on the potential 

environmental consequences of the determination of nonregulated status of DAS-81419-2 

soybean on TES species in the areas of the US where soybean is currently grown.

For its analysis on TES plants and critical habitat, APHIS focused on the agronomic differences 

between the regulated articles and soybean varieties currently grown; the potential for increased 

weediness; and the potential for gene movement to native plants, listed species, and species 

proposed for listing. 

For its analysis of effects on TES animals, APHIS focused on the implications of exposure to 

the novel proteins expressed in the plants as a result of the transformation, and the ability of the 

plants to serve as a host for a TES. The novel proteins associated with DAS-81419-2 soybean 

are listed in Table 4.

Table 4. Proteins expressed in the Event DAS-81419-2 Soybean. 

Protein Phenotypic Effects

phosphinothricin 

acetyltransferase (PAT)

Resistance to glufosinate

Cry1Ac Resistance to feeding by larval stages of specific 

lepidopteran insects

Cry1F Resistance to feeding by larval stages of specific 

lepidopteran insects

6.2 Potential Effects of DAS-81419-2 Soybean on TES and Critical 

Habitat

6.2.1 Threatened and Endangered Plant Species and Critical Habitat

The agronomic and morphologic characteristics data provided by DAS were used in the APHIS 

analysis of the weediness potential for DAS-81419-2 soybean, and further evaluated for the 

potential to impact TES and critical habitat. Agronomic studies conducted by DAS tested the 

hypothesis that the weediness potential of DAS-81419-2 soybean is unchanged with respect to 

conventional soybean produced by DAS (Dow-AgroSciences, 2012). No differences were 

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detected between DAS-81419-2 soybean and nontransgenic soybean in growth, reproduction, or 

interactions with pests and diseases, other than the intended effect of herbicide resistance (DowAgroSciences, 2012; USDA-APHIS, 2012b). Soybean possesses few of the characteristics of 

successful weeds, and has been cultivated around the globe without any report that it is a serious 

weed or that it forms persistent feral populations (USDA-APHIS, 2012b) Soybean cannot 

survive in the majority of the United States without human intervention (USDA-APHIS, 2012b), 

and it is easily controlled if volunteers appear in subsequent crops. The expression of the PAT 

protein providing herbicide resistance, and the Cry1Ac, and Cry1F proteins providing insect 

resistance in DAS-81419-2 soybean are unlikely to appreciably improve seedling establishment 

or increase weediness potential. APHIS has concluded the approval of a petition of nonregulated 

status for DAS-81419-2 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 

(USDA-APHIS, 2012b).

APHIS evaluated the potential of DAS-81419-2 soybean to cross with listed species. As 

previously discussed in the analysis of Gene Movement and Weediness and Plants, APHIS has 

determined that there is no risk to unrelated plant species from the cultivation of DAS-81419-2 

soybean. Soybean is highly self-pollinating and can only cross with other members of Glycine 

subgenus Soja. Wild soybean species are endemic in China, Korea, Japan, Taiwan and the 

former USSR; in the U.S. there are no Glycine species found outside of cultivation and the 

potential for outcrossing is minimal (OECD, 2000a; OECD, 2000b). After reviewing the list of 

threatened and endangered plant species in the U.S. states where soybean is grown, APHIS 

determined that DAS-81419-2 soybean would not be sexually compatible with any listed 

threatened or endangered plant species proposed for listing, as none of these listed plants are in 

the same genus nor are known to cross pollinate with species of the genus Glycine.

Based on agronomic field data, literature surveyed on soybean weediness potential, and no 

sexually compatibility of TES with soybean, APHIS has concluded that DAS-81419-2 soybean 

will have no effect on threatened or endangered plant species or critical habitat.

Threatened and Endangered Animal Species

For its effects analysis on TES animal species, APHIS focused on the likelihood of the species to 

be exposed to the toxins expressed in DAS-81419-2 soybean. Exposure of TES species to 

Cry1Ac and Cry1F is only likely if the species occur in the areas where soybean is grown, 

because soybean plant parts (seeds, pollen, crop debris) are not readily transported long distances 

without human intervention. Threatened and endangered animal species that may be exposed to 

the gene products in DAS-68416-4 soybean would be those TES that inhabit soybean fields and 

feed on DAS-68416-4 soybean. Few if any TES are likely to use soybean fields because they do 

not provide suitable habitat. Only whooping crane (Grus americana), sandhill crane (Grus 

canadensis pulla), piping plover (Charadrius melodus), interior least tern (Sterna antillarum), 

and Sprague’s pipit (Anthus spragueii; a candidatespecies) occasionally feed in farmed sites (US 

Fish and Wildlife Service, 2011). These bird species may visit soybean fields during migratory 

periods, but would not be present during normal farming operations (Krapu et al., 2004; US Fish 

and Wildlife Service, 2011) . In a study of soybean consumption by wildlife in Nebraska, results 

indicated that soybeans do not provide the high energy food source needed by cranes and 

waterfowl (Krapu et al., 2004). The Delmarva fox squirrel (Sciurus niger cinereus), which 

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inhabits mature forests of mixed hardwoods and pines, may be found adjacent to agricultural 

areas of the Delmarva Peninsula (US Fish and Wildlife Service, 2008). The squirrel forages for 

food in woodlots and openings, such as farm fields, with a diet that mainly includes acorns, 

nuts/seeds of hickory, beech, walnut, and loblolly pine. They also feed on tree buds and flowers, 

fungi, insects, fruit, and seeds in the spring and mature, green pine cones in the summer and 

early fall (US Fish and Wildlife Service, 2008). The Louisiana black bear (Ursus americanus 

luteolus), occurring in Louisiana, Mississippi, and Texas has been found to consume corn, 

berries, grasses, acorns, herbaceous vegetation, and other species of soft mast (Benson and 

Chamberlain, 2006).

The use of GE crops expressing Cry proteins has been shown to reduce the use broad spectrum 

insecticides without significant impacts on diversity of non-target insects (Romeis et al., 2006; 

Marvier et al., 2007; Wolfenbarger et al., 2008; Naranjo, 2009). Bt toxins expressed in 

transgenic plants for pest management are generally regarded as safe due to their mode of action, 

specificity, and fast degradation in the environment (Glare and O'Callaghan, 2000; Sanvido et 

al., 2007; Romeis et al., 2008). The specificity of Bt crystalline proteins to lepidopteran insect 

larvae, and not for other insects, birds, and mammals, results from the highly specific receptors 

for these proteins in the larvae midgut (Arora et al., 2007). Once activated by insect-specific 

proteases in the insect midgut, Cry proteins bind to receptors in the midgut. Binding leads to the 

formation of pores in the midgut membranes and ultimately to cell lysis and death. The specific 

binding of Bt-based Cry proteins to midgut membrane receptors is a key determinant of pest 

specificity (Showalter et al., 2009). 

Given the narrow spectrum of activity observed for Cry proteins (Pigott and Ellar, 2007; 

Wolfenbarger et al., 2008) the TES analysis is focused on taxa within the order Lepidoptera. 

Proximity relationships between potential growing sites where DAS-81419-2 could be planted 

and locations of T/E lepidopteran species were determined from the information contained in the 

FIFRA Endangered Species Task Force (FESTF) databases. Ecology and life history 

information for species identified as being present in soybean-growing counties was accessed 

from the U.S. Fish and Wildlife Service and NatureServe Explorer databases (NatureServe 

Explorer, 2012). 

Four lepidopteran butterfly species (Karner blue, Lycaeides melissa samuelis; Mitchell's satyr, 

Neonympha mitchellii mitchellii; Saint Francis' satyr, Neonympha mitchellii francisci; and 

Uncompahgre fritillary, Boloria acrocnema) were indicated to co-occur with soybean use sites in 

66 counties located in 13 states. Ecology and life history information demonstrated that habitat 

requirements for larvae and adults of three of the identified species (Mitchell's satyr, Saint 

Francis' satyr, and Uncompahgre fritillary) do not overlap with commercial soybean acreage, and 

are therefore not expected to be impacted by DAS-81419-2 cultivation. There is a possible 

overlap between the geographic range for Karner blue butterfly and soybean use sites; however, 

the potential for direct exposure to the Cry proteins produced by DAS-81419-2 soybean is 

negligible. Karner blue larvae feed only on lupines (Lupinus spp.). Soybean is neither identified 

as a larval food source, nor is soybean open-pollinated; thus DAS-81419-2 soybean pollen is 

highly unlikely to be deposited on lupine leaves. Furthermore, soybean is not identified as a 

nectaring source for Karner blue adults. Therefore, the risk posed to the Karner blue butterfly is 

considered negligible. 

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Cry1Ac, Cry1F, and PAT have been reviewed by USDA, U.S. EPA, and U.S. FDA regulatory 

agencies, with no safety implications under specified use (Section 1.2). In agreement with 

previous TES assessments for PAT, Cry1F, and Cry1Ac products, the assessment for DAS81419-2 supports a determination of no effect on threatened or endangered animal species. 

(USDA-APHIS, 1995; USDA-APHIS, 2004; USDA-APHIS, 2011a).

APHIS considered the possibility that DAS-81419-2 soybean could serve as host plant for a 

threatened or endangered species. A review of the species list reveals that there are no members 

of the genus Glycine that serve as a host plant for any threatened or endangered species. 

Combining the above information, cultivation of DAS-81419-2 soybean and its progeny are 

expected to have no effect on threatened or endangered animals.

Summary

After reviewing the possible effects of allowing the environmental release of DAS-81419-2 

soybean, APHIS has not identified any stressor that could affect the reproduction, numbers, or 

distribution of a listed TES or species proposed for listing. APHIS also considered the potential 

effect of a determination of nonregulated status of DAS-81419-2 soybean on designated critical 

habitat and habitat proposed for designation, and could identify no differences from effects that 

would occur from the production of other soybean varieties. Soybean is not considered a 

particularly competitive plant species and has been selected for domestication and cultivation 

under conditions not normally found in natural settings (US-EPA, 2010b). Soybean is not 

sexually compatible with, or serves as a host species for, any listed species or species proposed 

for listing. Consumption of DAS-81419-2 soybean by any listed species or species proposed for 

listing will not result in a toxic or allergic reaction. Based on these factors, APHIS has 

concluded that a determination of nonregulated status of DAS-81419-2 soybean, and the 

corresponding environmental release of these soybean varieties will have no effect on listed 

species or species proposed for listing, and would not affect designated habitat or habitat 

proposed for designation. Because of this no-effect determination, consultation under Section 

7(a)(2) of the Act or the concurrences of the USFWS or NMFS is not required.

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7 Appendix A. Relative Costs of Herbicides for Application

The relative cost of various herbicides or herbicide combinations cited by DowAgrosciences as 

typical of those used by their contract growers for soybean seed production. Reported as cost per 

acre based on small quantities, survey limited to North Dakota. (North Dakota State, 2012)

Herbicide-trade name Chemical name Cost per acre (mid-dose range)

Preplant herbicide use:

Valor Flumioxazin 12.00

Postplant herbicide use:

Classic Chlorimuron-methyl 6.75

First Rate Chloransulum-methyl 5.00

Marvel Fluthiacet-methyl and 

Fomesafen

N/A

Select Clethodim 8.45

Cadet Fluthiacet-methyl 7.65

FlexStar Fomesafen 13.15

FlexStar + Cadet+ Select 24.45

Liberty Glufosinate 19.25

Price per acre of a midrange herbicide application (unless none presented and then the lowest 

recommended rate was listed for each)

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