Pioneer Hi-Bred International, Inc. Petition (11-244-

01p) for Determination of Nonregulated Status of 

Insect-Resistant and Herbicide-Tolerant Pioneer 4114 

Maize: Event DP-004114-3

OECD Unique Identifier: DP-004114-3

Final Environmental Assessment 

May 2013

Agency Contact

Cindy Eck

USDA, APHIS, BRS 

4700 River Road, Unit 91 

Riverdale, MD 20737-1237 

Phone: (301) 734-0667

Fax: (301) 734-8910

Cynthia.A.Eck@aphis.usda.gov

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

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

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

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

at (202) 720–2600 (voice and TDD). 

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

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

opportunity provider and employer. 

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

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

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

information. 

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

and/or Federal agencies before they can be recommended. 
DRAFT PIONEER 4114 MAIZE

TABLE OF CONTENTS

SECTION PAGE

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

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

1.1 BACKGROUND.............................................................................................................1

1.2 PURPOSE OF PRODUCT ..............................................................................................2

1.3 COORDINATED FRAMEWORK REVIEW AND REGULATORY REVIEW..............3

1.4 PURPOSE AND NEED FOR USDA-APHIS ACTION...................................................5

1.5 PUBLIC INVOLVEMENT .............................................................................................5

1.6 ISSUES CONSIDERED..................................................................................................6

2 AFFECTED ENVIRONMENT...........................................................................................8

2.1 CORN – BACKGROUND INFORMATION ..................................................................9

2.2 AGRICULTURAL PRODUCTION OF CORN.............................................................10

2.2.1 Areas and Acreage of Corn Production.............................................................10

2.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs...............11

2.2.3 Organic Corn Farming and Specialty Corn Systems..........................................23

2.3 PHYSICAL ENVIRONMENT......................................................................................25

2.3.1 Soil Quality ......................................................................................................25

2.3.2 Water Resources...............................................................................................26

2.3.3 Air Quality .......................................................................................................27

2.3.4 Climate Change ................................................................................................27

2.4 BIOLOGICAL RESOURCES .......................................................................................29

2.4.1 Animal Communities........................................................................................29

2.4.2 Plant Communities...........................................................................................32

2.4.3 Soil Microorganisms ........................................................................................37

2.4.4 Biological Diversity .........................................................................................38

2.4.5 Gene Movement ...............................................................................................40

2.5 PUBLIC HEALTH........................................................................................................41

2.5.1 Human Health ..................................................................................................41

2.5.2 Worker Safety ..................................................................................................43

2.6 ANIMAL FEED............................................................................................................44

2.7 SOCIOECONOMIC......................................................................................................45

2.7.1 Domestic Economic Environment ....................................................................45

2.7.2 Trade Economic Environment ..........................................................................47

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3 ALTERNATIVES.............................................................................................................49

3.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE...............................49

3.2 PREFERRED ALTERNATIVE: DETERMINATION THAT PIONEER 4114 MAIZE IS

NO LONGER A REGULATED ARTICLE...................................................................49

3.3 ALTERNATIVES CONSIDERED BUT REJECTED FROM FURTHER 

CONSIDERATION.......................................................................................................50

3.3.1 Prohibit Any Pioneer 4114 Maize from Being Released ...................................50

3.3.2 Approve the Petition In Part .............................................................................51

3.3.3 Isolation Distance between Pioneer 4114 Maize and Non-GE Corn and 

Geographical Restrictions........................................................................................51

3.3.4 Requirement of Testing for Pioneer 4114 Maize...............................................52

3.4 COMPARISON OF ALTERNATIVES.........................................................................52

4 ENVIRONMENTAL CONSEQUENCES .........................................................................57

4.1 SCOPE OF THE ENVIRONMENTAL ANALYSIS .....................................................57

4.2 AGRICULTURAL PRODUCTION OF CORN.............................................................58

4.2.1 Areas and Acreage of Corn Production.............................................................59

4.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs...............60

4.2.3 Organic Corn Farming and Specialty Corn Production .....................................69

4.3 PHYSICAL ENVIRONMENT......................................................................................72

4.3.1 Soil Quality ......................................................................................................72

4.3.2 Water Resources...............................................................................................74

4.3.3 Air Quality .......................................................................................................77

4.3.4 Climate Change ................................................................................................78

4.4 BIOLOGICAL RESOURCES .......................................................................................79

4.4.1 Animal Communities........................................................................................79

4.4.2 Plant Communities...........................................................................................85

4.4.3 Soil Microorganisms ........................................................................................91

4.4.4 Biological Diversity .........................................................................................94

4.4.5 Gene Movement ...............................................................................................96

4.5 PUBLIC HEATH ..........................................................................................................99

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

4.5.2 Worker Safety ................................................................................................105

4.6 ANIMAL FEED..........................................................................................................107

4.6.1 No Action: Animal Feed.................................................................................107

4.6.2 Preferred Alternative: Animal Feed ................................................................108

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4.7 SOCIOECONOMIC....................................................................................................109

4.7.1 Domestic Economic Environment ..................................................................109

4.7.2 Trade Economic Environment ........................................................................111

5 CUMULATIVE IMPACTS.............................................................................................113

5.1 ASSUMPTIONS USED FOR THE CUMULATIVE IMPACTS ANALYSIS .............113

5.2 CUMULATIVE IMPACTS: AREAS AND ACREAGE OF CORN PRODUCTION...116

5.3 CUMULATIVE IMPACTS: AGRONOMIC PRACTICES: TILLAGE, CROP 

ROTATION, AND AGRONOMIC INPUTS...............................................................117

5.3.1 Tillage and Crop Rotation...............................................................................117

5.3.2 Agronomic Inputs...........................................................................................118

5.4 CUMULATIVE IMPACTS: ORGANIC CORN FARMING AND SPECIALTY CORN 

SYSTEMS...................................................................................................................120

5.4.1 Organic Corn Farming .....................................................................................120

5.4.2 Specialty Corn Production..............................................................................121

5.5 CUMULATIVE IMPACTS: SOIL QUALITY ............................................................122

5.6 CUMULATIVE IMPACTS: WATER RESOURCES..................................................123

5.7 CUMULATIVE IMPACTS: AIR QUALITY ..............................................................124

5.8 CUMULATIVE IMPACTS: CLIMATE CHANGE.....................................................125

5.9 CUMULATIVE IMPACTS: ANIMAL COMMUNITIES ...........................................126

5.9.1 Mammals and Birds........................................................................................126

5.9.2 Invertebrates...................................................................................................127

5.10 CUMULATIVE IMPACTS: PLANT COMMUNITIES............................................128

5.10.1 Surrounding Landscapes and Other Vegetation in Cornfields......................128

5.10.2 Corn as a Weed or Volunteer ......................................................................129

5.11 CUMULATIVE IMPACTS: SOIL MICROORGANISMS........................................130

5.12 CUMULATIVE IMPACTS: BIOLOGICAL DIVERSITY........................................131

5.13 CUMULATIVE IMPACTS: GENE MOVEMENT...................................................132

5.13.1 Vertical Gene Flow.....................................................................................132

5.13.2 Horizontal Gene Transfer............................................................................132

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5.14 CUMULATIVE IMPACTS: HUMAN HEALTH .....................................................133

5.15 CUMULATIVE IMPACTS: WORKER SAFETY ....................................................134

5.16 CUMULATIVE IMPACTS: ANIMAL FEED ..........................................................135

5.17 CUMULATIVE IMPACTS: DOMESTIC ECONOMIC ENVIRONMENT..............136

5.18 CUMULATIVE IMPACTS: TRADE ECONOMIC ENVIRONMENT.....................137

6 THREATENED AND ENDANGERED SPECIES..........................................................138

6.1 USDA-APHIS’ APPROACH TO EVALUATION OF POTENTIAL IMPACTS TO 

THREATENED AND ENDANGERED SPECIES......................................................138

6.2 POTENTIAL EFFECTS OF THE CULTIVATION OF PIONEER 4114 MAIZE ON 

TES.............................................................................................................................139

6.2.1 Potential Effects of Pioneer 4114 Maize on TES.............................................140

6.2.2 Potential Effects of the Use of Glufosinate Herbicides....................................145

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS ..............................................................150

7.1 EXECUTIVE ORDERS WITH DOMESTIC IMPLICATIONS ..................................150

7.2 INTERNATIONAL IMPLICATIONS.........................................................................152

7.3 COMPLIANCE WITH CLEAN WATER ACT AND CLEAN AIR ACT....................154

7.4 IMPACTS ON UNIQUE CHARACTERISTICS OF GEOGRAPHIC AREAS............154

7.5 NATIONAL HISTORIC PRESERVATION ACT (NHPA) OF 1966 AS AMENDED 155

8 BIBLIOGRAPHY ...........................................................................................................157

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LIST OF TABLES

Table 2-1. Percentage of herbicide-resistant, insect-resistant, stacked trait, total GE corn, and 

total corn acreage planted in selects states in 2012. ..................................................14

Table 2-2. Summary list of plant incorporated protectants (PIP) registered by the US-EPA.......18

Table 2-3. U.S. glyphosate-resistant (G/9) weeds through July 2012. ........................................34

Table 2-4. Photosystem II inhibitor-resistant* (C/1) weeds through July 2012...........................35

Table 2-5. U.S. glutamine synthase inhibitor1 (H/10) weeds through July 2012. .......................35

Table 3-1. Summary of potential impacts and consequences of alternatives...............................52

Table 4-1. US-EPA registrations1 for commercial corn products containing 1507 and/or 59122 

Maize.......................................................................................................................64

Table 4-2. USDA-APHIS nonregulated products expressing the PAT protein conferring 

resistance to DL-Phosphinothricin, the ammonium salt of glufosinate, also known as 

glufosinate ammonium.............................................................................................66

Table 4-3. Comparative control of herbicide-resistant weeds. (IPM, 2007; Heap, 2012)............88

Table 5-1. Bt insect resistant traits currently on the U.S. market. .............................................114

LIST OF FIGURES

Figure 2-1. Percent of total corn acres treated with pesticides from 2004-2011..........................16

Figure 2-2. Adoption of GE corn varieties with at least one herbicide-resistant trait and 

glyphosate in U.S. corn production, 1994 – 2010. ....................................................18

Figure 4-1. Adoption rates of three major tillage types in U.S. corn production, 1996 – 2010....61

APPENDICES

APPENDIX A FEDERAL REGISTER NOTICE REGARDING PUBLIC INPUT IN 

DEREGULATION PROCESS

APPENDIX B BAYER LIBERTY® LABEL

APPENDIX C APHIS THREATENED AND ENDANGERED SPECIES DECISION 

TREE FOR US-FWS CONSULTATIONS

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ACRONYMS AND ABBREVIATIONS

ae Acid equivalent

AIA advanced informed agreement

AMS Agricultural Market Share or Ammonium sulfate

ANZFS Australia and New Zealand Food Standards Agency

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BMP Best management practices

BRS Biotechnology Regulatory Services (within USDA–APHIS)

Bt Bacillus thuringiensis protein

CAA Clean Air Act

CBD Convention on Biological Diversity

CEQ Council of Environmental Quality

CFR Code of Federal Regulations (United States)

CH4 methane

CO carbon monoxide

CO2 carbon dioxide

COC Crop oil concentrate

CRP Conservation Reserve Program

Cry Protein The crystalline protein and active ingredient in the plant incorporated protectants 

derived from Bacillus thuringiensis

CWA Clean Water Act

DDGs Distillers dry grain solubles

DNA deoxyribonucleic acid

EA environmental assessment

EFSA European Food Safety Agency

EIS environmental impact statement

EO Executive Order

EPA U.S. Environmental Protection Agency

EQIP Environmental Quality Incentives Program

ESA Endangered Species Act of 1973

ESPP Endangered Species Protection Program

FFDCA Federal Food, Drug, and Cosmetic Act

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ACRONYMS AND ABBREVIATIONS

FFP food, feed, or processing

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FONSI Finding of No Significant Impact

FQPA Food Quality Protection Act

g/L grams per liter

GE genetically engineered

GHG greenhouse gas

GMO genetically modified organism

HFCS High fructose corn syrup

IPCC Intergovernmental Panel on Climate Change

IPM Integrated pest management

IRM Insect Resistance Management

ISHRW International Survey of Herbicide Resistant Weeds

ISPM International Standard for Phytosanitary Measure

IPPC International Plant Protection Convention

Lb Pound

LMO Living modified organism

LOEC Lowest observable effect concentration

MOU Memorandum of understanding

MSO methylated seed oil

N2O nitrous oxide

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

NEPA National Environmental Policy Act of 1969 and subsequent amendments

NHPA National Historic Preservation Act

NMFS National Marine Fisheries Service

NOEC No observable effect concentration

NRC National Research Council

NRCS National Resources Conservation Service

NOP National organic program

NPS Non-point source

OECD Organization for Economic Cooperation and Development

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ACRONYMS AND ABBREVIATIONS

PAT phosphinothricin-acetyl-transferase, an enzyme

pat The gene derived from Streptomyces viridochromogenes which encodes the PAT 

enzyme 

PIP Plant incorporated protectant

ppm Parts per million

PPRA Plant Pest Risk Assessment

PRA pest risk analysis

RNA ribonucleic acid

RSPM Regional Standards for Phytosanitary Measures

SOx Sulfur oxides

TES threatened and endangered species

TSCA Toxic Substances Control Act

U.S. United States

US-FDA U.S. Food and Drug Administration 

USDA U.S. Department of Agriculture

USDA-APHIS U.S. Department of Agriculture-Animal and Plant Health Inspection Service

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

USDA-ARMS U.S. Agricultural Resource Management Survey

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

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

USC United States Code

USFWS U.S. Fish and Wildlife Service

VEC Value enhanced corn

WPS Worker Protection Standard for Agricultural Pesticides

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1 PURPOSE AND NEED

1.1 BACKGROUND

On September 1, 2011, Pioneer Hi-Bred International, Inc. of Johnston, Iowa (recently renamed 

DuPont Pioneer, and referenced hereafter as Pioneer) petitioned (#11-244-01p) the United States 

Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) for a 

determination of nonregulated status of Pioneer 4114 corn (Maize) event DP-004114-3 (Pioneer, 

2011b). Pioneer 4114 corn (Maize) event DP-004114-3 is referenced hereafter as Pioneer 4114 

Maize. Pioneer 4114 Maize provides insect resistance to certain lepidopteran and coleopteran 

pests (e.g., European corn borer and corn rootworm, respectively) from the accumulation of three 

Cry proteins. Additionally, Pioneer 4114 Maize exhibits resistance1 to the glufosinate herbicide

from the incorporation of the phosphinothricin-acetyl-transferase (PAT) protein (Pioneer, 

2011b). Pioneer 4114 Maize is currently regulated under 7 Code of Federal Regulations (CFR)

Part 340. Interstate movements and field trials of Pioneer 4114 Maize have been conducted 

under permits issued or notifications acknowledged by USDA-APHIS since 2006. These field 

trials were conducted in diverse growing regions within the United States, including Arkansas, 

California, Colorado, Delaware, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Michigan, 

Minnesota, Missouri, Nebraska, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, 

Tennessee, Texas, and Wisconsin. Data resulting from these field trials are described in the 

Pioneer 4114 Maize petition (Pioneer, 2011b) and analyzed for plant pest risk in the USDAAPHIS Plant Pest Risk Assessment (PPRA) (USDA-APHIS, 2012e).

Pioneer’s petition stated that USDA-APHIS should not regulate Pioneer 4114 Maize because it 

does not present a plant pest risk. In the event of a determination of nonregulated status, the 

nonregulated status would include Pioneer 4114 Maize, any progeny derived from crosses 

between Pioneer 4114 Maize and conventional corn, and crosses of Pioneer 4114 Maize with 

other biotechnology-derived corn that are no longer subject to the regulatory requirements of 7 

CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000.

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, Herbicide Resistance 

Action Committee, Available: http://www.hracglobal.com/Publications/ManagementofHerbicideResistance.aspx, 

January 22 2013. 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 a 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 (Monsanto, "Petition for the Determination of Non-Regulated Status Fir GlyphosateTolerant Canola Mon 88302 ", ed. M. A. Wideman (Monsanto Company, 2011), vol. referenced the subject as, 

“Glyphosate-Tolerant Canola,” and used the term “herbicide-tolerant” throughout it documentation to describe 

it. This terminology can be considered synonymous with “herbicide-resistant” (HR) used in this EA.

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1.2 PURPOSE OF PRODUCT 

Pioneer 4114 Maize is a genetically engineered (GE) insect-resistant and herbicide-resistant corn 

product. Insect resistance in Pioneer 4114 Maize is derived from the accumulation of the 

insecticidal crystalline proteins2 Cry1F, Cry34Ab1, and Cry 35Ab1 (Pioneer, 2011b).

Additionally, resistance to the herbicide glufosinate in Pioneer 4114 Maize is conferred through

activity of the PAT protein (Pioneer, 2011b). The Cry1F, Cry34Ab1 and Cry 35Ab1 proteins are 

derived from the common soil bacterium, Bacillus thuringiensis (Bt); the PAT protein is derived 

from a common soil bacterium, Streptomyces viridochromogenes (Pioneer, 2011b). 

The Cry1F protein in Pioneer 4114 Maize is derived from Bt subsp. aizawai (USDA-APHIS, 

2012e). Cry1F is effective in controlling lepidopteran larvae such as European corn borer 

(Ostrinia nubilalis), a major maize pest (Pioneer, 2011b). The Cry34Ab1 and Cry35Ab1 proteins 

are derived from Bt strain PS149B1 (USDA-APHIS, 2012e). Together, Cry34Ab1 and 

Cry35Ab1 comprise an active binary insecticidal crystal protein that confers resistance to 

coleopteran corn rootworm pests, including western corn rootworm (Diabrotica virgifera 

virgifera), also a major maize pest (Pioneer, 2011b).

In addition to the Cry1F, Cry34Ab1, and Cry35Ab1 proteins, Pioneer 4114 Maize also contains 

the PAT protein, which confers resistance to glufosinate ammonium-based herbicides. The PAT 

protein acts to convert glufosinate ammonium into its inactive form, thus rendering the plant 

resistant to glufosinate ammonium (Pioneer, 2011b).

In Pioneer 4114 Maize, the genes for the Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins are 

contained on a single transformation construct and have been integrated at a single locus in the 

genome. This is in contrast to the commercially-available 1507 x 59122 Maize variety where the 

insertions for the events are located at two unlinked loci3 (Pioneer, 2011b; USDA-APHIS, 

2012e). Pioneer 4114 Maize is phenotypically identical to 1507 x 59122 Maize (Pioneer, 2011b; 

USDA-APHIS, 2012e); Pioneer 4114 Maize is a corn variety that will provide similar insect 

resistance/herbicide resistance to that of 1507 x 59122 Maize and function as an alternative to 

the breeding stack combination of the two previously approved events, 1507 Maize and 59122 

Maize. 

Pioneer 4114 Maize is not intended to be a stand-alone commercial product, but will be 

combined with other approved events using conventional breeding to create stacked and 

pyramided4 products with multiple modes of action for control of insect pests and corn weeds. 

As a single event with all genes located at a single locus, Pioneer 4114 Maize will be bred more 

2 Also known as Cry proteins or Bt proteins, after Bacillus thuringiensis.

3 In contrast to a single locus insertion, insertion in two loci means that genes have been inserted in two separate 

locations within a genome. For example, in 1507 x 59122 Maize, the gene encoding Cry1F is located in one location 

in the genome; whereas the gene encoding Cry34Ab1/Cry35Ab1 is located in another location in the genome.

4

Stacked products contain two or more genes targeting multiple pests; whereas pyramided products contain two or 

more genes targeting a single species.

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efficiently into new product offerings for growers that are customized to their local insect 

protection and agronomic needs. 

1.3 COORDINATED FRAMEWORK REVIEW AND REGULATORY REVIEW

Since 1986, the United States government has regulated GE organisms pursuant to a regulatory 

framework known as the Coordinated Framework for the Regulation of Biotechnology 

(Coordinated Framework) (EOP-OSTP, 1986; US-FDA, 1992). 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 (US-EPA), and the Food and Drug Administration (US-FDA).

USDA-APHIS

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

granted by the Plant Protection Act of 2000, as amended (7 United States Code (U.S.C.) 7701–

7772), regulate the introduction (importation, interstate movement, or release into the 

environment) of certain GE organisms and products. A GE organism is no longer subject to the 

plant pest provisions of the Plant Protection Act of 2000 or to the regulatory requirements of 7 

CFR Part 340 when USDA-APHIS determines that it is unlikely to pose a plant pest risk. A GE 

organism is considered a regulated article if the donor organism, recipient organism, vector, or 

vector agent used in engineering the organism belongs to one of the taxa listed in the regulation 

(7 CFR 340.2) and also is considered a plant pest. A GE organism also is regulated under Part 

340 when USDA-APHIS has reason to believe that the GE organism may be a plant pest or

USDA-APHIS does not have information to determine if the GE organism is unlikely to pose a 

plant pest risk. 

A person may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant 

Protection Act of 2000 or the regulations at 7 CFR 340. The petitioner is required to provide 

information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine 

whether the regulated article is unlikely to present a greater plant pest risk than the unmodified 

organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR Part 340 

or the plant pest provisions of the Plant Protection Act of 2000 when USDA-APHIS determines 

that it is unlikely to pose a plant pest risk.

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US-EPA

The US-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

US-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 US-EPA. Commercial 

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

Section 3 Registration with US-EPA. 

Under FIFRA (7 U.S.C. 136, et seq.), US-EPA regulates the use of pesticides (requiring 

registration of a pesticide for a specific use prior to distribution or sale of the pesticide for a 

proposed use pattern). US-EPA examines the ingredients of the pesticide; the particular site or 

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

disposal practices. Prior to registration for a new use for a new or previously registered pesticide,

US-EPA must determine through testing that the pesticide will not cause unreasonable adverse 

effects on humans, the environment, and non-target species when used in accordance with label 

instructions. US-EPA must also approve the language used on the pesticide label in accordance 

with 40 CFR Part 158. Once registered, a pesticide may not be used legally unless the use is 

consistent with the approved directions for use on the pesticide's label or labeling. 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 US-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, 2011d).

EPA also sets tolerances for residues of pesticides on and in food and animal feed, or establishes 

an exemption from the requirement for a tolerance, under the Federal Food, Drug, and Cosmetic 

Act (FFDCA). US-EPA is required, before establishing pesticide tolerance, to reach a safety 

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

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

US-FDA

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

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

plant varieties, including those derived from GE, in the Federal Register on May 29, 1992 (USFDA, 1992). Under this policy, US-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 US-FDA in complying with 

their obligations under Federal food safety laws prior to marketing.

More recently, in June 2006, US-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) for establishing 

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DRAFT PIONEER 4114 MAIZE

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 US-FDA, but the information may be used 

later in the biotechnology consultation.

On December 23, 2011, Pioneer submitted materials in support of a voluntary consultation to the

US-FDA for the Pioneer 4114 Maize (US-FDA Docket Number BNF 136). US-FDA completed 

its evaluation on March 25, 2013.

1.4 PURPOSE AND NEED FOR USDA-APHIS ACTION

Under the authority of the plant pest provisions of the Plant Protection Act of 2000 and 7 CFR 

Part 340, USDA-APHIS has issued regulations for the safe development and use of GE 

organisms. Any party can petition USDA-APHIS to seek a determination of nonregulated status 

for a GE organism that is regulated under 7 CFR 340. As required by 7 CFR 340.6, USDAAPHIS must respond to petitioners that request a determination of the regulated status of GE 

organisms, including GE plants such as Pioneer 4114 Maize. When a petition for nonregulated 

status is submitted, USDA-APHIS must make a determination 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 Plant Protection Act of 2000 when USDA-APHIS determines that it is unlikely to pose a 

plant pest risk.

USDA-APHIS must respond to a Pioneer petition for determination of nonregulated status of 

Pioneer 4114 Maize. 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 and subsequent amendments (NEPA) regulations and the USDA and USDA-APHIS

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

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

quality of the human environment5 that may result from a determination of nonregulated status 

for Pioneer 4114 Maize.

1.5 PUBLIC INVOLVEMENT

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

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

through a notice published in the Federal Register. When USDA-APHIS considered the petition 

complete, it prepared its PPRA and EA, and the three documents were made available for public 

comment for 60 days through a notice in the Federal Register. Although USDA-APHIS’ review 

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

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

5

 
DRAFT PIONEER 4114 MAIZE

of the Pioneer 4114 Maize is following a previously established approach, it is also important to 

acknowledge that USDA-APHIS recently has implemented a change to the public involvement 

process for select future deregulation decisions (as of March 6, 2012, (USDA-APHIS, 2012a)).

The issues raised by this product were relatively straightforward and no new issues were raised.

The issues discussed in this EA are those noted in section 1.6 for resources and also include

those of agricultural production of corn using various production methods and the environmental 

and food and feed safety of GE plants. These were addressed to analyze the potential 

environmental impacts of Pioneer 4114 Maize.

This EA, the petition submitted by Pioneer, and USDA-APHIS’s PPRA was available for public 

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

60-day period were analyzed and used to inform USDA-APHIS’ determination decision of the 

regulated status of Pioneer 4114 Maize and to assist USDA-APHIS in determining whether an 

Environmental Impact Statement (EIS) was required prior to the determination decision of the 

regulated status of this maize variety.

1.6 ISSUES CONSIDERED

The list of resource areas considered in this 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:

• Areas and Acreage of Corn Production

• Agronomic Practices

• Organic Corn Farming and Specialty Corn Production

Environmental Considerations

• Soil Quality

• Water Resources

• Air Quality 

• Climate Change

• Animal Communities

• Plant Communities

• Soil Microorganisms

• Biological Diversity

• Gene Movement

Public Health Considerations

• Human Health

• Worker Safety

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DRAFT PIONEER 4114 MAIZE

Livestock Health Considerations

• Animal Feed/Livestock Health

Socioeconomic Considerations

• Domestic Economic Environment

• Trade Economic Environment

Cumulative Impacts

Threatened and Endangered Species

Other United States Regulatory Approvals and Compliance with Other Laws

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DRAFT PIONEER 4114 MAIZE

2 AFFECTED ENVIRONMENT

The Affected Environment Section provides an overview of the biology and use of corn6

(Subsection 2.1 – Corn Background Information), followed by a discussion of the current 

condition of those aspects of the human environment potentially affected by a determination of 

nonregulated status of Pioneer 4114 Maize (Subsections 2.2 – 2.7). For this EA, those aspects of 

the human environment are: agricultural production of corn (Subsection 2.2); the physical 

environment (Subsection 2.3); biological resources (Subsection 2.4); public health (Subsection 

2.5); animal feed (Subsection 2.6); and socioeconomics (Subsection 2.7). Note that alternatives, 

environmental consequences, cumulative impacts, threatened and endangered species, and 

consideration of executive orders (EOs), standards, and treaties relating to environmental 

impacts are not presented in Section 2, but in Sections 3, 4, 5, 6, and 7, respectively.

Important to the description of the Affected Environment and the analysis of Environmental 

Consequences in this EA, Pioneer 4114 Maize notably contains traits from two GE maize 

varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant 

pest provisions of the Plant Protection Act of 2000. The Cry1F protein and its associated genetic 

elements in Pioneer 4114 Maize are identical to those in DAS‐01507‐1 Maize (hereafter referred 

to as 1507 Maize), which had a determination of nonregulated status by USDA, and was 

registered by the EPA and was reviewed by the US-FDA in 2001 (US-FDA, 2001; USDAAPHIS, 2001; US-EPA, 2010f; Pioneer, 2011b). The binary Cry proteins, Cry34Ab1 and 

Cry35Ab1, and their associated genetic elements are identical to those in DAS‐59122‐7 Maize 

(hereafter referred to as 59122 Maize), which had a determination of nonregulated status by 

USDA in 2005, was registered by US-EPA in 2005, and was reviewed by US-FDA in 2004 (USFDA, 2004; USDA-APHIS, 2005; US-EPA, 2010f; Pioneer, 2011b). Both 1507 and 59122 

Maize contain the PAT protein, which itself has had USDA nonregulated status since 1995 and 

has been commercially cultivated in the United States since 1996 (USDA-APHIS, 1995).

The regulatory history of 1507 and 59122 Maize bears repeating here because commercial corn 

hybrids based on these varieties, including a conventional hybrid breeding stack of the two lines, 

1507 x 59122 Maize, are now licensed broadly across the seed industry (Pioneer, 2011b). The 

1507 x 59122 breeding stack combination was reviewed and registered by US-EPA in 2005 (USEPA, 2010f). Similarly, in 2005, the European Food and Safety Authority (EFSA) approved the 

marketing of 1507 maize for import, feed and industrial processing, and cultivation (EFSA, 

2005); in 2007, approved 59122 for import, feed and industrial processing (EFSA, 2007); and 

since 2009, has reviewed and approved at least four commercial hybrids based on the 1507 x 

59122 hybrid stacks for food and feed uses, import and processing (EFSA, 2009a; EFSA; EFSA, 

2010; EFSA). In each case, EFSA concluded that the hybrid products were unlikely to have any 

adverse effects on human or animal health or on the environment (EFSA, 2009a; EFSA; EFSA, 

2010; EFSA).

6 Zea mays, corn, and maize refer to the same domesticated plant species and will be used interchangeably 

throughout the text. 

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DRAFT PIONEER 4114 MAIZE

As of 2011, approximately 88% of all corn planted in the U.S. was GE. Forty-nine percent were

stacked (multiple) gene varieties having both herbicide- and insect-resistant traits (USDA-ERS, 

2011b). Herbicide-resistant varieties account for 23%, and insect-resistant-only cultivars 

comprised 16%. In 2010, commercial products containing 1507 x 59122 Maize were grown on 

approximately 14 million acres or approximately 16% of U.S. maize acres (GfK Kynetec, 2010; 

Pioneer, 2011b).

Other value-added corn GE traits include enhanced oil, starch, or nutritional characteristics and 

drought tolerance (USGC, 2010; USDA-APHIS, 2012c). The first herbicide-resistant corn 

variety released in 1995 was glufosinate resistant and the first stacked hybrid varieties were 

released in 1997 (USDA-APHIS, 2012c). The adoption of herbicide-resistant corn was relatively 

low in 2000 (approximately 6%), yet all states surveyed as part of the Economic Research 

Service (ERS) corn estimating program steadily increased their adoption through 2011 (Figure 4) 

(USDA-ERS, 2011b). The amount of herbicide-resistant-only corn planted in the U.S. increased 

between 2000 and 2007 from 6% to 24% of all planted corn, yet has remained relatively steady 

since then at 22% to 23% of all planted corn (USDA-ERS, 2011b). In addition, adoption of 

stacked corn varieties (those containing both herbicide- and insect-resistant traits) increased from 

1% in 2000 to 49% in 2011 (USDA-ERS, 2011b).

Accordingly, as the events contained in Pioneer 4114 Maize are already commercially cultivated, 

this EA presents a summary of the Cry and the PAT proteins and the events in Pioneer 4114 

Maize as part of the Affected Environment and in the Environmental Consequences analysis. 

2.1 CORN – BACKGROUND INFORMATION

Corn (Z. mays subsp. mays L.) is a member of the Maydeae tribe of the grass family, Poaceae 

(OECD, 2003). Corn is a wind-pollinated, monoecious, annual grass species with imperfect 

flowers7 (Wozniak, 2002; OECD, 2003). Corn has been domesticated through selection of key 

agronomic characters, such as a non-shattering rachis, grain yield, and resistance to pests 

(Wozniak, 2002). A large variety of corn types (e.g., dent, flint, flour, pop, and sweet) have been 

developed through standard breeding techniques (Wozniak, 2002; OECD, 2003).

Corn cultivars and landraces are both known to have two sets of chromosomes with a total

number of 20 and consequently, can largely crossbreed. However, some evidence for genetic 

incompatibility exists within the species (e.g., popcorn x dent crosses; Mexican maize landraces 

x Chalco teosinte) (Wozniak, 2002). The closest wild relatives of corn are various Zea taxa 

known as “teosinte” (Ellstrand et al., 2007a). More than 40 landraces of maize have been 

identified in Mexico, and over 250 throughout the Americas (OECD, 2003). Several of the 

identified subspecies are identified as teosinte, including Z. mays subsp. mexicana; Z. mays

subsp. parviglumis; Zea diploperennis; and Zea luxurians (OECD, 2003; Ellstrand et al., 2007a). 

None of the teosinte subspecies are known to occur naturally north of the tropical and subtropical 

areas of Mexico, Guatemala, Honduras, and Nicaragua (Sanchez et al., 2011), although teosinte 

7 A morphological feature that limits inbreeding, where spatially separate tassels (male flowers) and silks (female 

flowers) are found on the same plant, , Gene Flow Assessment for Plant-Incorporated Protectants by the 

Biopesticide and Pollution Prevention Division, U.S. Epa: The Ohio State University..

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DRAFT PIONEER 4114 MAIZE

may be found as introduced populations in botanical gardens and as feral populations of Zea

mexicana in Florida, Maryland, and Alabama (USDA-NRCS, 2012b), and feral populations of 

Zea perennis in South Carolina (USDA-NRCS, 2012c).

Corn has food, feed, and industrial uses (USDA-ERS, 2012c). A variety of food and industrial 

products are derived from corn, including starches8, sweeteners9, corn oil, organic acids, and 

alcohols10 (CRA, 2011; Pioneer, 2011b). In 2012, approximately 45% of total U.S. corn 

production was dedicated to ethanol production for biofuels and 42% for animal feed (USDAERS, 2012c). In addition to being cultivated for ethanol and animal feed production, 

approximately 6% of the total corn production is harvested for silage (USDA-NASS, 2012c).

2.2 AGRICULTURAL PRODUCTION OF CORN

2.2.1 Areas and Acreage of Corn Production

Corn is an annual plant typically grown in zones of abundant rainfall and fertile soils (OECD, 

2003). In U.S. temperate regions, moisture levels and number of frost-free days are ideal for corn 

to be grown (see, e.g., IPM, 2004; IPM, 2007). However, through selective breeding to variable 

conditions of humidity, sunlight, altitude, and temperature, corn is cultivated in a variety of 

regions in the United States (OECD, 2003). 

Corn is grown in all 48 states of the continental United States, with production concentrated in 

the U.S. Corn Belt. The Corn Belt is loosely defined as the states of Illinois, Iowa, Indiana, the 

eastern portions of South Dakota and Nebraska, western Kentucky and Ohio, and the northern 

two-thirds of Missouri (USDA-NASS, 2012b). Iowa and Illinois, the two top corn-producing 

states, typically account for slightly more than one-third of the total U.S. corn crop (USDANASS, 2012b).

In the 2012 production year, corn was cultivated in the United States on approximately 96 

million acres, representing a 5% increase in corn acreage from 2011 (USDA-NASS, 2012b). 

Corn production in 2011 was estimated at 12.44 billion bushels and valued at an estimated $5.15 

to $5.65 per bushel (USDA-NASS, 2012b). Corn is the most widely cultivated feed grain in the 

United States, accounting for approximately 96% of total value and production of feed grains 

(USDA-ERS, 2012c). In addition to demand as feed grain, strong demand for ethanol production 

has resulted in higher corn prices and corresponding incentives to growers to increase corn 

acreage (USDA-ERS, 2012c). In many cases, growers have increased corn acreage by adjusting 

corn plantings between corn, soybean, and other crops (USDA-ERS, 2012c).

8 Starches include unmodified and modified starches, dextrin, and maltodextrin.

9 Sweeteners include glucose, dextrose, fructose, and high-fructose corn syrup.

10 Alcohols include beverage, industrial and fuel ethanols.

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DRAFT PIONEER 4114 MAIZE

2.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs

Agronomic practices associated with corn production include several crop management systems 

that are available to growers. Conventional farming, as defined in this document, includes any 

farming system where synthetic pesticides or fertilizers may be used. This type of farming may 

vary between occasional use of synthetic pesticides and fertilizers to those that depend on regular 

inputs for successful crop production. This definition of conventional farming may also include 

the use of GE corn varieties that are no longer subject to the regulatory requirements of 7 CFR 

Part 340 or the plant pest provisions of the Plant Protection Act of 2000. Organic systems 

exclude certain production methods, such as synthetic agricultural inputs and GE crops, and are 

discussed in Subsection 2.2.3 – Organic Corn Farming and Specialty Corn Systems.

Growers can choose from several different crop management practices depending upon 

geographic cultivation area and end-use market (see, e.g., IPM, 2004; IPM, 2007). However, 

common corn agronomic practices include tillage, the selection of crop rotation system, and the 

use of agronomic inputs. The following subsections introduce the basic cultivation requirements 

of corn and the agronomic practices commonly employed to produce corn in the United States.

2.2.2.1 Tillage

Prior to planting of corn seed, tillage may be used to prepare a seedbed, address soil compaction,

incorporate fertilizers and herbicides, manage water movement both within and out of a 

production field, control weeds, and reduce the incidence of insect pests and plant disease (Hoeft 

et al., 2000; Christensen, 2002; Fawcett and Towery, 2002; Tacker et al., 2006; Givens et al., 

2009; NRC, 2010).

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

by the remaining plant residue on the field. Conventional tillage is associated with intensive 

plowing and less than 15% crop residue in the field; reduced tillage is associated with 15 to 30% 

crop residue; and conservation tillage is associated with at least 30% crop residue remaining in 

the field (US-EPA, 2009). Conservation tillage includes no-till, mulch-till, no-till fallow, striptill, ridge-till, and zero-till practices (IPM, 2007). Conservation tillage is valued as a means to 

enhance soil quality, preserve soil moisture, and reduce soil erosion (USDA-ERS, 1997; USDANRCS, 2005; Heatherly et al., 2009).

The choice to till is dependent upon a variety of factors (Hoeft et al., 2000), such as:

• Desired yields;

• Soil type and moisture storage capacity;

• Crop rotation pattern;

• Prevalence of insect and weed pests;

• Risk of soil compaction and erosion;

• The need for crop residue or animal waste disposal; and 

• Management and time constraints. 

Tillage can increase yields in some cropping systems and soils, and not in others. For example, if 

a tillage system increases moisture infiltration, production potentially increases in response. 

Tillage can also impact the amount of agronomic inputs needed to maintain soil fertility and 

11
DRAFT PIONEER 4114 MAIZE

moisture and the amount of agricultural chemicals needed to control insect and weed pests 

(Olson and Sander, 1988; Hoeft et al., 2000; Cerdeira and Duke, 2006).

According to the 2010 USDA Agricultural Resource Management Survey (USDA-ARMS), an 

average of 1.4 tillage operations per corn crop were conducted, leaving an average of 34% plant

residue on the soil surface after planting (USDA-ERS, 2011c). The plant residue coverage of the 

soil after planting was approximately 65% for no-till corn production in 2005; however, no-till 

corn production represented only 24% of all corn acres planted in the United States (USDAERS, 2011c). In 2010, 62% of planted corn acreage in 19 surveyed states was dedicated to no-till 

or minimum till systems (USDA-NASS, 2011d). 

Increases in total acres dedicated to conservation tillage have been attributed to increased use of 

GE crops, reducing the need for mechanical weed control. However, the change in tillage 

practices in corn was less dramatic than other crops such as soybean or cotton, as many growers 

of corn had already changed to conservation tillage systems as a means to reduce soil erosion 

(Fawcett and Towery, 2002; Givens et al., 2009).

Conservation tillage has been identified as a potential challenge for corn disease management.

The surface residues have been identified as an inoculum source for certain plant pathogens11

(Robertson et al., 2009). This is especially a problem for growers who cultivate corn-to-corn 

with minimal tillage (Robertson et al., 2009). Corn-to-corn cultivation is discussed in the 

following subsection, and refers to the cultivation of corn in consecutive years in the same field 

(Erickson and Lowenberg-DeBoer, 2005). For each of these diseases, the disease agent 

overwinters in the cool and moist soil, and the pathogenic inoculum from the corn residue then 

infects the next year’s crop (Robertson et al., 2009). Recommended disease control measures are 

already practiced and include cultivation of resistant hybrids, crop rotation, and more careful 

balancing of conservation tillage with residue management, with resistant hybrids the most 

economical method (Robertson et al., 2009).

2.2.2.2 Crop Rotation

Crop rotation is the successive planting of different crops on the same land in subsequent years. 

Crop rotation may be used to optimize soil nutrition and fertility, reduce pathogen loads, control 

volunteers12, and limit the potential for weeds to develop resistance to herbicides (IPM, 2004; 

USDA-ERS, 2005; IPM, 2007). Since 1991, 75% of corn planted acreage has been in some form 

of rotation in the United States (USDA-ERS, 2005). Corn can be grown successfully in 

conservation tillage system if rotated with other crops, such as wheat or soybean, which may

reduce some of the problems encountered with conservation tillage (IPM, 2007). Other crops 

11 Diseases identified as related to corn residues include Anthracnose (caused by the fungus Colletotrichium 

graminicola), Eyespot (caused by the fungus Kabatiella zea), Goss’s wilt (caused by the bacteria Corynebactierum 

nebraskense), Gray leaf spot (caused by the fungus Cercospora zeae-maydis), and Northern corn leaf blight (caused 

by the fungus Helminthosporium turcicum) A. Robertson, R.F. Nyvall and C.A. Martinson, Controlling Corn 

Diseases in Conservation Tillage (Ames, IA: Iowa State University, University Extension, 2009)..

12 See Subsection 2.4.2.2 – Corn as a Weed or Volunteer.

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DRAFT PIONEER 4114 MAIZE

used in rotation with corn vary regionally and may include cotton, oats, canola, sugar beets, 

peanut, rye, barley and forage (Peel, 1998; see e.g., IPM, 2004; Pioneer, 2012).

The benefits of corn rotation with, for example, soybean are many and include (Al-Kaisi et al., 

2003):

• Improved yield and profitability of one or both crops;

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

• Increased residue cover resulting in reduced soil erosion; 

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

• Reduced soil erosion; 

• Increased soil organic matter;

• Improved soil tilth and soil physical properties; and

• Reduced runoff of nutrients, herbicides, and insecticides.

The high global demand for corn-produced ethanol is increasing corn prices relative to soybean 

prices. The increased corn demand and commodity prices encourage more corn-to-corn acreage, 

rather than corn-soybean rotations, which in turn contribute to overall increased U.S. corn 

acreage (Doerge, 2007). Consecutive plantings of corn require more management than cornsoybean rotations, and increase risk of disease and insect pest pressure (IPM, 2004; Erickson and 

Lowenberg-DeBoer, 2005; Sawyer, 2007; Stockton, 2007). Consecutive plantings of corn also 

have been associated with the development of resistance by western corn rootworm (D.

virgifera) and other pests to management practices utilizing Bt (Gassmann et al., 2011). Btresistance is further discussed in Subsection 2.4.1.2 – Invertebrates.

2.2.2.3 Agronomic Inputs

Corn production typically involves the extensive use of agronomic inputs to maximize grain 

yield (Ritchie et al., 2008). Agronomic inputs may include fertilizers to supplement available 

nutrients in the soil; pesticides to reduce pest plant, insect, and microbial populations; and 

irrigation to ensure normal plant growth and development (Howell et al., 1998; IPM, 2007).

Fertilizer and pesticide use is discussed in this subsection; irrigation is discussed in Subsection 

2.3.2 – Water Resources.

Fertilization

Given the importance of nutrient availability to corn agronomic performance, fertilization is 

widely practiced (Ritchie et al., 2008). Soil and foliar macronutrient applications to corn 

primarily include nitrogen, phosphorous (phosphate), potassium (potash), calcium, and sulfur, 

with other micronutrient supplements such as zinc, iron, and magnesium applied as needed

(Espinoza and Ross, 2006). In a 2010 survey of program states, USDA-NASS reported that

nitrogen was applied to 97% of corn acreage at an average of 140 pounds per acre (lb./acre); 

phosphate was applied to 78% of corn acreage at an average rate of 60 lb./acre; and potash was 

applied to 61% of corn acreage at a rate of 79 lb./acre (USDA-NASS, 2011a). The survey found 

that sulfur was applied less extensively at a rate of 13 lb./acre to 15% of corn acres (USDANASS, 2011a).

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DRAFT PIONEER 4114 MAIZE

Pesticides

Cornfields are host to a variety of insect and plant pests that reduce both the quality and quantity 

of grain at harvest. Due to improvements in pesticide technology, corn growers have increasingly 

turned to chemical control in corn production (Smith and Scott, 2006).

Pesticides may be applied pre-planting13, pre-emergence

14, or post-emergence15. Pesticide 

application strategies are often dependent on the corn variety cultivated. Growers may choose 

from a large number of corn varieties produced from traditional breeding or GE systems (NCGA, 

2012). Like the major commodity crops, cotton and soybean, GE varieties of corn have been 

adopted widely in the past decade. In 2000, approximately 25% of cultivated corn varieties were 

GE. This included 18% insect-resistant varieties, 6% herbicide-resistant varieties, and 1% 

stacked varieties (Benbrook, 2009). By 2011, total GE corn adoption had increased to 88% of 

U.S. corn acreage. GE insect-resistant varieties represented 16% of this total; whereas GE 

herbicide-resistant and GE stacked varieties represented 23% and 49%, respectively (NCGA, 

2012; USDA-NASS, 2012b). Table 2-1 shows the current GE corn adoption rates in the United 

States.

Table 2-1. Percentage of herbicide-resistant, insect-resistant, stacked trait, total GE corn, 

and total corn acreage planted in selects states in 2012.

State

Herbicideresistant (%)Insect-resistant 

(Bt) (%)

Stacked*

(%) Total GE (%)

Total Corn Acreage 

Planted (1000 acres)

Illinois 18 14 53 85 13,000

Indiana 15 9 60 84 6,200

Iowa 15 12 64 91 14,000

Kansas 19 20 51 90 4,700

Michigan 26 8 52 86 2,600

Minnesota 22 19 47 88 8,700

Missouri 20 18 48 86 3,600

Nebraska 20 16 55 91 9,900

North Dakota 36 17 43 96 3,400

Ohio 20 13 43 76 3,900

South Dakota 23 9 62 94 6,000

Texas 21 20 44 85 1,900

Wisconsin 23 10 53 86 4,350

Total United 

States 21 15 52 88 96,450

* Stacked corn varieties contain at least one herbicide-resistant trait. Source: (USDA-NASS, 2012b)

Factors influencing the adoption of insect-resistant crops include (Brookes and Barfoot, 2010): 

13 Before the crop seed has been planted, i.e. “burn-down” herbicide application.

14 After the crop seed has been planted but before crop seed germination.

15 After crop seed germination.

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DRAFT PIONEER 4114 MAIZE

• Reduced risk of crop loss associated with insect pests;

• Convenience associated with less time spent on crop scouting and/or applying 

insecticides;

• Savings in fuel use mainly from reduced number of spray applications and reduced 

tillage;

• Savings in the use of machinery (for spraying and possibly reduced harvesting times);

• Improved quality (e.g., lower levels of mycotoxins16 in GE insect-resistant corn);

• Improved health and safety for farmers and farm workers from reduced handling and use 

of pesticides;

• Easier crop husbandry practices; and

• Facilitation of second crop cultivation.

Factors influencing the adoption of herbicide-resistant crops include (Brookes and Barfoot, 

2010): 

• Ease of use associated with broad-spectrum, post-emergent herbicides and the 

increased/longer time window for spraying; 

• Reduction in damage to crop arising from the application of post-emergent herbicides; 

• Ability to use alternative production technologies such as no/reduced tillage practices;

• Time and fuel savings from the adoption of no/reduced till compared to equivalent 

conventional crop management practices;

• Ease of weed control leading to cleaner crops and reduced harvesting time and costs, and 

thereby improving harvest quality and premium price for quality; and

• Avoidance of potential damage from soil-incorporated residual herbicides in crops grown 

in subsequent seasons.

The selection of an insect-resistant and/or herbicide-resistant variety influences a corn grower’s 

pest management strategy. Figure 2-1 shows the percent of total corn acres treated with the major 

types of agricultural pesticides from 2004 – 2011. The graph suggests that herbicide use as a 

percent of total corn acres has remained relatively constant, insecticide use has decreased, seed 

treatments have substantially increased, and foliar fungicide applications have increased to a 

lesser extent. Further discussion of these trends is presented in the following subsections on 

insecticides, herbicides, and microbial pest management. 

16 Mycotoxins are compounds produced by some corn fungal pathogens that may pose a human health risk. A wellknown example is aflatoxin, produced by the fungus genus Aspergillus. (See, e.g., 

http://www.ansci.cornell.edu/plants/toxicagents/aflatoxin/aflatoxin.html, accessed 10/1/12.)

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DRAFT PIONEER 4114 MAIZE

Figure 2-1. Percent of total corn acres treated with pesticides from 2004-2011.

Source: (Pioneer, 2011b)

Pesticides - Insecticides

In 2010, approximately 12% of corn acreage was treated with insecticides, with the most 

abundantly applied (listed in order of total pounds applied) being chlorpyrifos for corn 

rootworm, earworms, and European corn borer (1% of the acreage, with total applications of 

approximately 478,000 pounds); tefluthrin for control of corn rootworm (3% of the acreage, with 

total applications of 242,000 pounds); and tebupirimphos for corn rootworm and seed corn 

maggot (2% of the acreage, with total applications of 195,000 pounds) (USDA-NASS, 2011a). 

Most seed corn, both conventional and GE, is treated with insecticide in order to combat corn 

pests which attack the seed (Pioneer, 2011b). Chemical insecticides commonly used in corn seed 

treatment control seed corn insect pests such as flea beetles (which vector bacterial wilts), 

cutworm larvae, seedcorn maggots, white grubs, and wireworms include imidacloprid, 

clothianidin, fipronil, permethrin, and thiamethoxam (Whitworth et al., 2013). 

The introduction of Cry proteins from B. thuringiensis into corn plants has transformed insect 

pest management. There has been a steady decline in the application of insecticides in recent 

years attributed, in part, to the adoption of corn varieties incorporating these Cry proteins 

(Brookes and Barfoot, 2010; Benbrook, 2012). The Cry proteins from Bt are generally target 

specific (e.g., Lepidoptera vs. Coleoptera) (OECD, 2007). This target specificity allows a grower 

to select a corn variety containing a Cry protein specific to an insect pest. For example, Cry1F in 

1507 Maize targets lepidopteran pests and Cry34Ab1/Cry35Ab1 in 59122 Maize to target 

coleopteran pests (Pioneer, 2011b; Pioneer, 2012). The advantage of this target specificity is that 

the grower can then avoid the application of broad-spectrum insecticides (Brookes and Barfoot, 

2010), allowing corn growers to reduce insecticide applications (Brookes and Barfoot, 2010; 

Benbrook, 2012). This provides benefits to growers and the environment from the reduction of 

exposure to insecticides and a corresponding reduction in costs to the grower associated with 

insecticide purchases and applications (US-EPA, 2010b; US-EPA, 2010a; US-EPA, 2010f).

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DRAFT PIONEER 4114 MAIZE

In 2012, 52% of the total U.S. corn acreage was planted in a stacked variety containing at least 

one Bt trait (USDA-NASS, 2012b). The US-EPA reviews PIPs, such as the Cry proteins, 

pursuant to FIFRA, and publishes exemptions from tolerance pursuant to its authority under 

FFDCA. Since 1995, the US-EPA has registered over 35 crops expressing one or more proteins 

derived from Bt (US-EPA, 2011b). Table 2-2 provides a summary list of the PIPs registered by 

the US-EPA. The US-EPA has published full tolerance exemptions for the Cry proteins (USEPA, 2007a)

17. 

Pesticides - Herbicides

Herbicides were applied to 98% of corn acreage in 2010 (USDA-NASS, 2011a). A 2010 survey 

of corn growers showed the following three herbicides as the most commonly applied:

glyphosate (66% of the acreage, ~57 million pounds); atrazine (61% of the acreage, ~51 million 

pounds applied); and acetochlor (25% of the acreage, ~28 million pounds) (USDA-NASS, 

2011b; USDA-NASS, 2011a). Of the glyphosate totals, most (89.4%) was in the form of 

glyphosate isopropylamine salt; 8.2% of was in the form of glyphosate; 0.07% was in the form 

of glyphosate ammonium salt; and 2.4% was in the form of glyphosate potassium salt. An 

unspecified amount of glyphosate dimethylamine salt was used in 2010 (USDA-NASS, 2011a).

17 As noted in Subsection 1.3, under its FFDCA authority, the EPA will publish an exemption from the requirement for a tolerance when it has 

completed comprehensive review of the toxicity and exposure data and completed health and animal risk assessment studies see 

http://www.epa.gov/opp00001/factsheets/stprf.htm#some for an overview of the EPA tolerance exemption processUS-EPA, Setting Tolerances 

for Pesticide Residues in Foods, 2012f, Available: http://www.epa.gov/pesticides/factsheets/stprf.htm, 11 October 2012.. An exemption from 

tolerance for the Cry proteins means that the EPA completed its review and found a reasonable certainty of no harm under the FFDCA, as 

amended by the FQPA. 

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DRAFT PIONEER 4114 MAIZE

Table 2-2. Summary list of plant incorporated protectants (PIP) registered by the US-EPA.

PIP Event Crop Registration Date

Cry 3A Bt Potato May, 1995

Cry 1Ab Bt Corn August, 1995

Cry 1Ac Bt Cotton October 1995

Cry 9C Bt Corn May, 1998

Cry 1F* Bt Corn May, 2001

Cry 3Bb1 Bt Corn February 2003

Cry 34Ab1 and Cry 35Ab1* Bt Corn August, 2005

Cry 2Ab2 Bt Cotton September, 2005

Vip3Aa19 Bt Cotton June, 2006

Vip 3Aa20 Bt Corn February 2008

Note: This table presents a summary of the US-EPA’s PIP Registrations since 1995. Multiple registrations of the same PIP event are not shown.

The complete US-EPA PIP Registration list can be found at http://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm

* Represents PIPs present in Pioneer 4114 Maize, the subject of this EA.

Like insect-resistant corn varieties, the introduction of herbicide-resistant corn varieties has 

substantially affected how corn is produced in the United States. The introduction of herbicideresistant corn varieties allowed the post-emergent application of some herbicides, simplifying a 

grower’s weed management strategy.

In particular, glyphosate-resistant corn varieties have strongly influenced weed management 

strategies (Figure 2-2). Although glyphosate-resistant corn has not substantially affected the

percentage of corn acreage managed with herbicides, the introduction of glyphosate-resistant 

corn varieties has resulted in the substitution of glyphosate for some other corn herbicides

(Figure 2-3) (Brookes and Barfoot, 2012; Vencill et al., 2012).

Figure 2-2. Adoption of GE corn varieties with at least one herbicide-resistant trait and 

glyphosate in U.S. corn production, 1994 – 2010.

Source: USDA-ERS (2011a) and USDA-NASS (1996; 2002; 2006; 2011a).

In addition to glyphosate-resistant corn varieties, glufosinate-resistant corn varieties are also 

cultivated in the United States. Glyphosate-resistant and glufosinate-resistant corn are the most 

0

20

40

60

80

1994 2001 2005 2010

Percent of U.S. corn acreage

Year

GE adoption

Glyphosate use

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common GE herbicide-resistant corn varieties currently cultivated in the United States. Figure 2-

4 illustrates the percent of U.S. corn acres treated with glyphosate or glufosinate.

Figure 2-3. Percent of U.S. corn acres treated with glyphosate or glufosinate.

Source: (Pioneer, 2011b).

Although glufosinate-resistant corn has been available since 1996, the use of glufosinate on total 

corn acres has remained stable and low over the past decade, with between 2% and 6% of the

total U.S. corn acreage treated with glufosinate (Pioneer, 2011b). In 2010, 515,000 lbs. of 

glufosinate was applied to 2% of U.S. corn acreage (USDA-NASS, 2011e). In contrast, 

57,536,000 lbs. of glyphosate was applied to 66% of U.S. corn acres in 2010 (USDA-NASS, 

2011e). 

Growers have selected glyphosate over glufosinate based on several reasons, including (Pioneer, 

2011b):

• Glufosinate has limited systemic activity compared to glyphosate; 

• Higher volumes of water (and higher pressure in spray nozzles) are needed for 

glufosinate compared to glyphosate;

• The window of application for effective control of weeds for glufosinate is narrower than 

for glyphosate; 

• Popularity of glyphosate-resistant soybeans allows for growers to use glyphosate on all 

their GE crops in a corn/soybean operation; and 

• Potentially higher relative cost of glufosinate compared to glyphosate.

Long-term trends related to herbicide use resulting from the utilization of GE technologies are 

the subject of much debate (Benbrook, 2009; Fernandez-Cornejo et al., 2009; Brookes and 

Barfoot, 2010; Benbrook, 2012; Brookes and Barfoot, 2012). Benbrook reported that the 

adoption of herbicide-resistant crops has resulted in an increase in the volume of herbicides 

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DRAFT PIONEER 4114 MAIZE

applied to crops (see, e.g., Benbrook, 2009; Benbrook, 2012). Benbrook noted that between 1996 

and 2001, herbicide use declined apparently in direct response to the adoption of herbicideresistant crops. However, since 2001, herbicide use has increased (Benbrook, 2009; Benbrook, 

2012). Benbrook suggests that the reported increases in herbicide use during the last decade 

reflect an increase in glyphosate applications as more glyphosate-resistant crops are planted with 

an associated increase in use of other herbicides used to control glyphosate-resistant weeds 

(Benbrook, 2009; Benbrook, 2012). Other authors interpret the herbicide use data differently

(see, Brookes and Barfoot, 2012; Brookes et al., 2012). Benbrook's analysis of trends in 

herbicide use is based on assumptions that may lead to overestimates of herbicide use in 

herbicide-resistant crop programs, including assumptions of herbicide usage on conventional 

crops that may be underestimated, extrapolation of trends to years where no USDA data are 

available, and not accounting for the role of increased crop acreage in the estimated increases in 

herbicide use (Brookes et al., 2012). Further, Benbrook’s analysis fails to consider the differing 

environmental profiles of herbicides used, particularly the substitution of relatively 

environmentally benign products for those with less environmentally friendly profiles (Brookes 

et al., 2012). In contrast to Benbrook's findings, Brookes and Barfoot (2012) estimate that GM 

crop adoption in the United States reduced the use of pesticides in the United States by 246 

million kg compared to what might reasonably be expected if GM crops were no longer 

available.

Total use (i.e., pounds of active ingredient per acre) does not reflect the environmental fate or 

toxicity of the herbicide. Consequently, the total use metric does not allow comparison of 

herbicides.

In 2011, it was estimated that glyphosate was applied to approximately 80% of U.S. corn acres 

(Pioneer, 2011b). However, increased selection pressure resulting from the wide-spread adoption 

of glyphosate-resistant crops, along with the reductions in the use of other herbicides and weed 

management practices, has resulted in both weed population shifts and increasing glyphosate 

resistance among some weed populations (Owen, 2008; Duke and Powles). The emergence of 

resistance to herbicides is not exclusive to glyphosate-resistant crops and corresponding weed 

species (Norsworthy et al., 2012).

Weed resistance to herbicides is a concern in agricultural production and the wide-spread 

adoption of herbicide-resistant crops, especially GE-derived glyphosate-resistant crops, has 

dramatically changed the approach that farmers take to avoid yield losses from weeds (Gianessi, 

2008; Duke and Powles, 2009b). Subsection 2.4 – Biological Resources, provides a discussion 

on the role of herbicide-resistant weeds in corn weed management. 

To reduce development of resistant weeds, growers can continually practice weed management 

strategies by choosing different herbicides with alternative modes of action, including auxin 

growth regulators, amino acid inhibitors, chlorophyll pigment inhibitors, or lipid biosynthesis 

inhibitors (Ross and Childs, 2011). The practice of using herbicides with alternative modes of 

action could potentially diminish the populations of glyphosate-resistant weeds and reduce the 

likelihood of the development of new herbicide-resistant weed populations (Dill et al., 2008; 

Duke and Powles, 2008; Owen, 2008; Duke and Powles, 2009b; Pioneer, 2011b; Norsworthy et 

al., 2012; Vencill et al., 2012). 

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Weed control methods differ depending on a number of factors including regional practices, 

grower resources, and crop trait; the techniques may be direct (e.g., mechanical, biological, and 

chemical) or indirect (e.g., cultural) (Hoeft et al., 2000). Additionally, weed management 

strategies need to be carefully planned to integrate appropriate technologies into an economic 

level of control (Shaw et al., 2011). A diverse strategy is essential to reduce selection pressure on 

the weed population (Powles and Preston, 2009). 

Recently, the Weed Science Society of America presented a series of best management practices 

(BMPs) to address herbicide resistance in weeds. These recommendations are (Norsworthy et al., 

2012):

• Reduce the weed seedbank through diversified programs that minimize weed seed 

production;

• Implement a herbicide MOA labeling system for all herbicide products and conduct an 

awareness campaign;

• Communicate that discovery of new, effective herbicide MOAs is rare and that the 

existing herbicide resource is exhaustible;

• Demonstrate the benefits and costs of proactive, diversified weed-management systems 

for the mitigation of HR [herbicide-resistant] weeds;

• Foster the development of incentives by government agencies and industry that conserve 

critical herbicide MOAs as a means to encourage adoption of best practices;

• Promote the application of full-labeled rates at the appropriate weed and crop growth 

stage. When tank mixtures are employed to control the range of weeds present in a field, 

each product should be used at the specified label rate appropriate for the weeds present.

• Identify and promote individual BMPs that fit specific farming segments with the greatest 

potential impact;

• Engage the public and private sectors in the promotion of BMPs, including those 

concerning appropriate herbicide use; and

• Direct federal, state, and industry finding to research addressing the substantial 

knowledge gaps in BMPs for herbicide resistance and to support cooperative extension 

services as vital agents in education for resistance management.

Glufosinate

The herbicide glufosinate ammonium was first registered with the US-EPA in 1993 for home, 

non-food and farmstead weed control uses (OSTP, 2001), and received its first crop-product 

registration in 2000 (US-EPA, 2008b). The US-EPA has published exemptions for resistance for

both glufosinate and the PAT protein (US-EPA, 2010d). Glufosinate is a non-selective foliar 

herbicide that is used for pre-plant and post-emergence control of broadleaf weeds. Glufosinate 

inhibits glutamine synthetase, resulting in the overproduction of ammonia in plant tissues and 

ultimately resulting in plant death (US-EPA, 2008b). 

Glufosinate is available in several formulations, and is sold under the trade names Basta, Ignite, 

Rely, Liberty®, Remove, AEH, Finale, and Derringer F. A copy of a sample label for Liberty®, a 

Bayer formulation, is provided in Appendix B. Although the Liberty® label limits the use of that 

formulation to corn, soybeans, and canola resistant to the product, glufosinate ammonium is 

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

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DRAFT PIONEER 4114 MAIZE

potatoes, rice, soybeans, sugar beets, and tree nuts (US-EPA, 2008b). Registrations for non-crop 

areas include golf course turf, residential lawns, ornamentals, and a variety of industrial, 

residential, and public areas (US-EPA, 2008b). Aerial and ground spraying are allowed, with a 

wide range of application rates. 

The mode of action is not changed by these formulations and applications, but the chemical and 

physical properties of each formulation influence the selection of equipment, mitigation 

measures adopted in the field to minimize off-target impacts, and formulation-specific safety 

measures. Glufosinate is not a dermal irritant or a dermal sensitizer and has been deemed a 

toxicity category III for acute oral, dermal, and inhalation toxicity (US-EPA, 2003). Glufosinate 

is highly water soluble (1,370 g/L), and has a half-life in soil ranging from 3 to 70 days, 

dependent upon soil type and moisture content (Clewis et al., 2008; Jariani et al., 2010). 

As of the March 2008 Glufosinate Summary Document Registration Review, there were 

insufficient data available on terrestrial plant toxicity for an ecological assessment to be 

completed (US-EPA, 2008b). Based on the data collected as of the 2008 review summary, 

however, the areas of concern are impacts to non-target plants, chronic toxicity to mammals, and 

the indirect impacts to terrestrial animals from potential alterations in aquatic plant communities 

(US-EPA, 2008b). The EPA requires additional plant toxicity and field dissipation studies to 

determine potential impacts of typical end-use products. Existing environmental assessments of 

the toxicity of glufosinate to animal species indicated a relatively low direct risk, but high risk to 

plants composing the animals’ habitat (US-EPA, 2008b). 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 (US-EPA, 2008b). For 

birds, glufosinate is practically non-toxic on an acute and subacute dietary basis; therefore, the 

risk potential is presumed to be low (US-EPA, 2008b).The US-EPA label for this herbicide 

includes use restrictions and safety measures. FIFRA requires that registered herbicides be

applied in accordance with these label restrictions. 

Pesticides - Fungicides

In addition to pesticide inputs to control invertebrates (insecticides) and weeds (herbicides),

growers may also apply fungicides to control certain fungal diseases on corn. These treatments 

include both foliar fungicide applications to treat certain diseases as well as seed treatments to 

manage both insect pests of corn seed as well as certain fungal diseases. This practice is not 

universal, and varies by grower and region depending upon the specific disease (Hoeft et al., 

2000; Ruhl, 2007). Some of the common fungal diseases on corn include Anthracnose leaf blight 

(C. graminicola), common rust (Puccinia sorghi), eyespot (K. zeae), gray leaf spot (C. zeamaydis), northern corn leaf blight (Exserohilum turcicum), northern corn leaf spot (Bipolaris 

zeicola), and seed rot (multiple causes, fungal and bacterial, see, e.g., Hoeft et al., 2000; Ruhl, 

2007). 

Historically, foliar applications of fungicides were not common, and fungal disease management 

was focused on selection of disease-resistant hybrids, crop rotation to break the disease cycle,

and tillage to encourage decomposition of crop residues that were reservoirs for the disease (see, 

e.g., Purdue, 2012) The corn-to-corn rotations discussed previously in Subsection 2.2.2.2 – Crop 

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Rotation, along with conservation tillage, has resulted in an increased disease risk in some areas 

(Robertson et al., 2007; Robertson and Mueller, 2007). Corn yields have been reported to 

increase as a result of these foliar applications of fungicides (Robertson and Mueller, 2007).

2.2.3 Organic Corn Farming and Specialty Corn Systems

2.2.3.1 Organic Corn

In the United States, only crops produced using specific methods and certified under USDA’s

Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic 

farming can be marketed and labeled as “organic” (Ronald and Fouche, 2006; USDA-AMS, 

2010). The NOP is administered by USDA’s AMS. The USDA maintains current information on 

the domestic organic commodity market 

at: http://www.nal.usda.gov/afsic/pubs/organicstats.shtml. 

Organic certification is a process-based certification, not a certification of the end product. The 

certification process specifies and audits the methods and procedures by which the product is 

produced (Ronald and Fouche, 2006). In accordance with NOP, an accredited organic certifying 

agent conducts an annual review of the certified operation’s organic system plan and makes onsite inspections of the certified operation and its records. Organic growers must maintain records 

to show that production and handling procedures comply with USDA organic standards. 

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

guidance under 7 CFR §205.105—

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

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

without the use of:

(a) Synthetic substances and ingredients,...

(e) Excluded methods,...

Excluded methods are then defined at 7 CFR §205.2 as—

A variety of methods used to genetically modify organisms or influence their 

growth and development by means that are not possible under natural conditions 

or processes and are not considered compatible with organic production. Such 

methods include cell fusion, microencapsulation and macroencapsulation, and 

recombinant DNA technology (including gene deletion, gene doubling, 

introducing a foreign gene, and changing the positions of genes when achieved by 

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

traditional breeding, conjugation, fermentation, hybridization, in vitro 

fertilization, or tissue culture.

Organic farming operations, as described by the NOP, require organic production operations to 

have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded 

methods from adjoining land that is not under organic management. There is no specific size of a 

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DRAFT PIONEER 4114 MAIZE

buffer zone between organic crops and nonorganic crops (MOSES, 2009). Organic production 

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

accredited certifying agent. This plan enables the production operation to achieve and document 

compliance with the National Organic Standards, including the prohibition on the use of 

excluded methods. In NOP organic systems, the use of GE crops is excluded (USDA-AMS, 

2010).

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

organic seed, planting earlier or later than neighboring farmers who may be using GE crops so 

that the crops will flower at different times, and employing adequate isolation distances between 

the organic fields and the fields of neighbors to minimize the chance that pollen will be carried 

between the fields (NCAT, 2003). Although the National Organic Standards prohibit the use of 

excluded methods, they do not require testing of inputs or products for the presence of excluded 

methods. The presence of a detectable residue of a product of excluded methods alone does not 

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

current NOP regulations do not specify an acceptable threshold level for the adventitious 

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

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

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

with the products of excluded methods as detailed in their approved organic system plan (Ronald 

and Fouche, 2006; USDA-AMS, 2010).

The organic farming plan used as the basis for organic certification should include a description 

of practices used to prevent or reduce the likelihood of unwanted substances, like GE pollen or 

seed, at each step in the farming operation, such as planting, harvesting, storing, and transporting 

the crop (Kuepper, 2002; Riddle, 2004; Krueger, 2007; Roth, 2011). Organic corn production 

begins with certified organically grown seed (Diver et al., 2008). The adventitious presence of 

GE material in organic corn is a concern because corn naturally cross-pollinates (Coulter et al., 

2010). Although GE pollen is frequently cited as a concern, non-organic products can be 

introduced accidently from impure seed; seed admixture; volunteer plants; and residual nonorganic seed in the equipment, vehicles, and facilities (Coulter et al., 2010; Mallory-Smith and 

Sanchez-Olguin, 2011). Organic farming plans should include how the risk of GE pollen or comingling of seed will be monitored (Roth, 2011). Farmers using organic methods are requested 

to let neighboring farmers know that they are using organic production practices and request that 

the neighbors also help the organic farmer reduce potential contamination events (NCAT, 2003; 

Krueger, 2007). Delayed planting has been used successfully by some organic corn producers to 

control weeds and to avoid potential contamination by GE pollen from adjacent fields (Roth, 

2011). The late planting allows the organic corn grower to conduct a secondary tillage pass 

before planting to control early emerged weeds. Moreover, the late planting results in a later 

silking in the corn flower thereby avoiding pollen contamination from GE fields which have 

been planted earlier (Roth, 2011).

Although conventional corn yields (e.g., bushels per acre) tend to be higher than organic yields, 

net returns (e.g., price per bushel) from organic acres continue to be greater than net returns from 

conventional acres, with a 16% premium received for organic growers reported in 2008 

(Kuepper, 2002; Coulter et al., 2010; Roth, 2011). Certified organic corn acreage is a relatively 

small percentage of overall corn production in the United States. The most recently available 

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data show 169,000 acres of certified organic corn production in 2011, which represented

approximately 0.20% of the 92 million acres of corn planted in 2011 (USDA-NASS, 2012a). The 

approximately 169,000 acres in 2011 represent a decrease from the approximately 195,000 

certified organic corn acres cultivated in 2008 (USDA-NASS, 2012a).

2.2.3.2 Specialty Corn 

Thomison and Geyer (2011) estimated that approximately 5% of the total U.S. corn acreage, or 

approximately 4 million acres, was devoted to specialty corn varieties. Specialty corn varieties 

have been developed and marketed as Value Enhanced Corn (VEC) (USDA-FAS, 2004).

Varieties cultivated as specialty corn included high oil, white, waxy, blue corn, hard 

endosperm/food grade, high-amylose, high lysine, high oleic oil, low phytate, nutritionally 

enhanced, high extractable starch, high total fermentable (for ethanol), popcorn, pharmaceutical 

and industrial corns, and organic (Thomison and Geyer, 2011). The leading specialty corn states 

include Illinois, Iowa, Nebraska, and Indiana (Thomison and Geyer, 2011).

Similar to the production of conventional seed, industry quality standards for specialty crop 

products have led these seed producers and growers to employ a variety of techniques to ensure 

that their products are not pollinated by or commingled with conventional or GE crops 

(Bradford, 2006). Common practices include maintaining isolation distances to prevent pollen 

movement from other corn sources, planting border or barrier rows to intercept pollen, and 

employing natural vegetative barriers to pollen, including fallow fields and hedgerows

(Wozniak, 2002; NCAT, 2003). The Federal Seed Act Regulations provide additional details on 

Certified seed production (see 7 CFR §201, et seq.). Field monitoring for off-types is generally 

carried out by company staff and state crop improvement associations (Bradford, 2006). Seed 

handling standards are established by the American Organization of Seed Certifying Agencies 

(AOSCA) to reduce the likelihood of seed source mixing during planting, harvesting, 

transporting, storage, cleaning, and ginning (AOSCA, 2004). In general, the conventional 

management practices used for conventional seed production are sufficient to meet standards for 

the production of specialty crop seed (Bradford, 2006). 

2.3 PHYSICAL ENVIRONMENT 

2.3.1 Soil Quality

Soil quality on managed lands may be directly affected by the agricultural practices on that land 

(USDA-NRCS, 2006c). In particular, soil quality of agricultural land is directly affected by 

tillage strategies. As discussed in Subsection 2.2.2.1, tillage is an integral part of production 

agriculture (Givens et al., 2009). Conservation practices, including conservation tillage, have 

been developed to reduce field tillage and thus reduce the corresponding soil erosion and runoff

(USDA-NRCS, 2006c). By definition, conservation tillage leaves at least 30% of the soil covered 

by crop residue (Peet, 2001). In conservation tillage programs, the new crop is planted into the 

plant residue or in narrow strips of tilled soil. This is in comparison to conventional tillage where 

the seedbed is disrupted through plowing (to turn the soil surface over), disking (to reduce the 

size of soil clods created by plowing), and harrowing (to reduce the size of clods left by disking) 

(Peet, 2001).

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DRAFT PIONEER 4114 MAIZE

As conservation tillage practices have been adopted, there is a corresponding benefit to soil. In 

addition to an increase in soil organic matter, total soil loss on highly erodible croplands and 

non-highly erodible croplands decreased from 462 million tons per year to 281 million tons per 

year or by 39.2% from 1982 to 2003 (USDA-NRCS, 2006b). The reduction in soil erosion is also 

attributed to a decrease in the number of acres of highly erodible cropland being cultivated 

(USDA-NRCS, 2006b). This decrease in soil erosion carries a corresponding benefit in water 

resources, and will be discussed in Subsection 2.3.2 – Water Resources.

Corn tillage strategies may directly and indirectly affect soil quality. Corn plant residues

remaining in a field in a conservation tillage production system may impede cultivation 

equipment and cause cool, wet soils (Werblow, 2007). Cool, wet soils can delay germination and 

cause yield losses up to 10% (Neilsen, 2010). These concerns can each be addressed through a 

number of corn cultivation techniques, including corn varieties developed to thrive in cool, wet 

soils; seed treatments for insect and disease control; selection of appropriate equipment to 

manage high-residue conditions; and judicious use of appropriate herbicides to control weeds 

remaining in the conservation tillage fields (NCGA, 2007b; Werblow, 2007).

2.3.2 Water Resources

Corn is a water-sensitive crop with a relatively low tolerance for drought compared to other 

cultivated crops. Corn requires approximately 4,000 gallons through the growing season to 

produce one bushel of grain, or approximately 600,000 gallons per acre for each growing season

(NCGA, 2007a). Corn stress response and its respective water demand is variable over the 

growing season, with the greatest water demand occurring during the silk production stage in 

mid-season (Farahani and Smith, 2011). During this stage, the water requirement is estimated at 

approximately two inches of water per week (or 0.3 inches per day) (Heiniger, 2000; Farahani 

and Smith, 2011).

Corn water demand is met by a combination of natural rainfall, stored soil moisture from 

precipitation before the growing season, and sometimes supplemental irrigation during the 

growing season (Heiniger, 2000; Farahani and Smith, 2011). The vast majority of corn acreage 

does not require supplemental irrigation (USDA-NASS, 2009). In 2010, approximately 11 

million U.S. corn acres were irrigated, representing approximately 9% of the total corn acreage 

(NCGA, 2009). However, for those corn acres that require supplemental moisture, groundwater 

is the major source of water for irrigation and is used on almost 90% of irrigated corn acreage in 

the United States (Christensen, 2002).

In addition to direct use of water, agricultural production of corn may affect water resources 

through erosion and runoff of nutrients and suspended sediments from farm fields, and

infiltration of groundwater by supplemental nutrients and pesticides. This type of non-point 

source (NPS) pollution is the primary source of water quality impacts on surveyed rivers and 

lakes and a major contributor to groundwater contamination. Common management practices 

that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the 

application of pesticides, herbicides, and fertilizers. The primary cause of NPS pollution, 

however, is increased sedimentation in surface waters following soil erosion (US-EPA, 2005).

Agricultural pollutants released by soil erosion include sediments, fertilizers, and pesticides that 

are introduced to area lakes and streams when they are carried off fields by rain or irrigation 

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DRAFT PIONEER 4114 MAIZE

waters (US-EPA, 2005). Increased sediment loads to surface waters can directly affect fish, 

aquatic invertebrates, and other wildlife maintenance and survival. It also reduces the amount of 

light penetration in water which directly affects aquatic plants. Soil erosion-mediated 

sedimentation may also increase fertilizer runoff, thereby increasing nutrient loading and 

facilitating higher water turbidity, algal blooms, and oxygen depletion (US-EPA, 2005). 

2.3.3 Air Quality

Agricultural production of corn may affect air quality in direct and indirect ways. Agriculture 

directly affects air quality through common agricultural practices and may include smoke from 

agricultural burning and vehicle exhaust associated with agricultural equipment. In particular, 

aerial application of pesticides may cause air quality impacts from drift and diffusion; pesticides 

also may volatilize after application or may move with the wind as droplets or as constituents of 

entrained materials in wind-eroded soils (Vogel et al., 2008).

Agricultural production of corn may also indirectly affect air quality through common 

management practices, such as the emission of greenhouse gases (GHG, i.e., carbon dioxide) 

from tillage or the use of nitrogen fertilizer (i.e., nitrous oxide) (Hoeft et al., 2000; USDANRCS, 2006a; Aneja et al., 2009; US-EPA, 2012b).

Many of the conservation plans and practices being developed by growers have an air quality 

focus which target reductions in air emissions from agricultural operations (USDA-NRCS, 

2006a). Practices to improve air quality include conservation tillage, residue management, wind 

breaks, road treatments, burn management, prunings shredding, feed management, manure 

management, integrated pest management, chemical storage, nutrient management, fertilizer 

injection, chemigation and fertigation (inclusion in irrigation systems), conservation irrigation, 

scrubbers, and equipment calibration (USDA-NRCS, 2006a). Conservation tillage practices 

resulting in improved air quality include: fewer tractor passes across a field, thus decreasing dust 

generation and tractor emissions; and an increase in surface plant residues and untilled organic 

matter which physically hold the soil in place and reduce wind erosion (Baker et al., 2005; 

USDA-NRCS, 2006a). The USDA has estimated that the adoption of conservation management 

plans in the San Joaquin Valley of California had reduced air emissions by 34 tons daily, or more 

than 20% of the total emissions attributed to agricultural practices after a year of implementation

(Baker et al., 2005; USDA-NRCS, 2006a).

2.3.4 Climate Change

Climate change represents a statistical change in global climate conditions, including shifts in the 

frequency of extreme weather. Agriculture is recognized as a direct (e.g., exhaust from 

equipment) and indirect (e.g., agricultural-related soil disturbance) source of GHG emissions.

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

human-induced GHG in the United States (US-EPA, 2012b). Emissions of GHG released from 

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

nitrogen oxides (N2O), methane (CH4), reactive organic gases, particulate matter, and sulfur 

oxides (SOx) (US-EPA, 2012b). Nitrous oxides, methane and carbon dioxide are the primary 

GHGs resulting from agricultural activities (US-EPA, 2012b). Agricultural soil management 

practices, including nitrogen-based fertilizer application and cropping practices, represent the 

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DRAFT PIONEER 4114 MAIZE

largest source of U.S. nitrous oxide emissions; croplands account for 68% of the total N2O 

emissions attributable to agricultural land uses (US-EPA, 2012b). Agricultural sources of 

methane emissions are associated primarily with enteric emissions of gas from cattle and manure 

management. Carbon dioxide also is a substantial GHG associated with several agricultural 

practices, including certain land uses and energy consumption (US-EPA; US-EPA, 2012c). 

The contribution of agriculture to climate change largely is dependent on the production 

practices employed, the region in which the commodities are grown, and the individual choices 

made by growers. For example, emissions of nitrous oxide, produced naturally in soils through 

microbial nitrification and denitrification, can be influenced dramatically by fertilization, 

introduction of grazing animals, cultivation of nitrogen-fixing crops and forage (e.g., alfalfa), 

retention of crop residues (i.e., no-till conservation), irrigation, and fallowing of land (US-EPA, 

2012b). These same agricultural practices can influence the decomposition of carbon-containing 

organic matter sequestered in soil, resulting in conversion to carbon dioxide and subsequent loss 

to the atmosphere (US-EPA, 2012b). On-site emissions associated with farm machinery can be 

reduced by half for some crops when changing from conventional tillage to no-till systems 

(Nelson et al., 2009). Conversion of crop land to pasture results in increase nitrogen 

sequestration in soils (US-EPA, 2012b). Tillage contributes to the release of GHG because of the 

loss of carbon dioxide (CO2) to the atmosphere, and the exposure and oxidation of soil organic 

matter (Baker et al., 2005). No-till practices generally sequester more carbon in the soil due to 

less soil disturbance, higher soil moisture, and increased biomass inputs from surface residues 

(West, N.D.). The gross carbon sequestration value used for corn, taken from the national 

assessment data, is 595 kg carbon/ha/yr (approximately 530 lbs/acre) (West, N.D.). Corn crops 

using no-till practices have the potential to sequester an additional net 288 kg carbon/ha/yr 

(approximately 263 lbs/acre) compared to conventional tillage (West, N.D.). The carbon 

footprint of corn is directly affected by its associated cultivation practices; corn cultivation has 

been estimated to produce higher total CO2 emissions than wheat or soybean, and lower total 

emissions than cotton or rice (Nelson et al., 2009).

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

practices on different soil types, noting that carbon emission rates differ between mineral soils 

and organic soils (US-EPA, 2012b). Mineral soils contain from 1 to 6% organic carbon by 

weight in their natural state; whereas organic soils may contain as much as 20% carbon by 

weight (US-EPA, 2012b). In mineral soils, up to 50% of the soil organic carbon can be released 

to the atmosphere on the initial conversion; however, over time, the soil establishes a new 

equilibrium that reflects a balance between carbon inputs from decaying plant matter and organic 

amendments and carbon losses from microbial decomposition (US-EPA, 2012b). Organic soils, 

with their depth and richness in carbon content, continue to release carbon to the atmosphere for 

a longer period of time (US-EPA, 2012b). The US-EPA has estimated that mineral soil-based 

cropland areas sequestered over 45.7 Tg CO2 Eq18 in 2008, as compared with carbon emissions 

from organic soil-based croplands of 27.7 Tg CO2 Eq (US-EPA, 2012b). The adoption of 

18 The global warming potential of greenhouse gases are measured against the reference gas CO2, and are reported as 

teragrams (or million metric tons) of CO2 Equivalent, expressed as Tg CO2 Eq.

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conservation tillage, particularly in the Midwest regions with mineral soil shows the highest rates 

of carbon sequestration (US-EPA, 2012b).

Although agriculture may influence climate change, climate change may reciprocally affect 

agriculture. In response to climate change, the current range of weeds and pests of agriculture 

may increase (Field et al., 2007). Current agricultural practices will be required to change in 

response to these changes in the ranges of weeds and pests of agriculture (Field et al., 2007). 

Climate change potentially may also provide a positive impact to agriculture in general. The 

Intergovernmental Panel on Climate Change (IPCC) predicts that potential climate change in 

North America may result in an increase in crop yield by 5-20% for this century (Field et al., 

2007). However, this positive impact will not be observed across all growing regions. The IPCC 

report notes that certain regions of the United States will be impacted negatively because the 

available water resources may be reduced substantially. Note that the extent of climate change 

effects on agriculture is highly speculative. Nevertheless, North American production is expected 

to adapt to climate change impacts with improved cultivars and responsive farm management 

(Field et al., 2007).

2.4 BIOLOGICAL RESOURCES

2.4.1 Animal Communities

2.4.1.1 Birds and Mammals

Compared to natural areas, agricultural production fields generally have reduced animal 

populations (Dale et al., 2010). However, corn production fields may be host to a variety of 

animal species, despite monoculture conditions and perpetual disturbances (e.g., planting and 

harvesting) associated with common agricultural practices (Palmer et al., 1992; Vercauteren and 

Hygnostrom, 1993). Some birds and mammals may use cornfields at various times throughout 

the corn production cycle for reproduction, though most birds and mammals that utilize 

cornfields are ground-foraging omnivores that feed on the corn grain remaining in the fields 

following harvest (Palmer et al., 1992; Vercauteren and Hygnostrom, 1993; Krapu et al., 2004).

The types and numbers of birds that inhabit cornfields may vary regionally and seasonally; 

however, the numbers are low in general, although some of the birds are considered agricultural 

pests (Patterson and Best, 1996; see also: Purdue, 2010). Most of the birds that utilize cornfields 

are ground-foraging omnivores that feed on corn seed, sprouting corn, and the corn remaining in 

the fields following harvest. Bird species commonly observed foraging on corn include (Dolbeer, 

1990; Patterson and Best, 1996; Purdue; Southern States, 2010; Mullen, 2011):

• Red-winged blackbird (Agelaius phoeniceus);

• Grackle (Quiscalus quiscula);

• Horned lark (Eremophila alpestris);

• Brown-headed cowbird (Molothrus ater);

• Vesper sparrow (Pooecetes gramineus);

• Ring-necked pheasant (Phasianus colchicus);

• Wild turkey (Meleagris gallopavo);

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DRAFT PIONEER 4114 MAIZE

• American crow (Corvus brachyrhynchos); and 

• Various quail species.

Following harvest, it is common to find large flocks of Canada geese (Branta canadensis), snow 

geese (Chen caerulescens), sandhill cranes (Grus canadensis), and other migratory waterfowl in 

cornfields (Sparling and Krapu, 1994; Taft and Elphick, 2007; Sherfy et al., 2011). 

Depending on the region, a variety of mammals may also forage in a cornfield. For the most part, 

herbivorous and omnivorous mammals feed on the ear at various stages of growth. Large- to 

medium-sized mammals that are common foragers of cornfields include (ODNR, 2001; DeVault 

et al., 2007; Stewart et al., 2007; Beasley and Rhodes Jr., 2008; Illinois, 2012):

• White-tailed deer (Odocoileus virginianus);

• Raccoon (Procyon lotor);

• Feral pigs (Sus scrofa); and

• Woodchuck (Marmota monax).

The most notable of these are the white-tailed deer and raccoon. White-tailed deer often inhabit 

woodlots adjacent to cornfields and frequent these fields for both food and cover throughout the 

latter half of the corn growing season (Vercauteren and Hygnostrom, 1993). The effects of 

white-tailed deer herbivory are well documented (Vercauteren and Hygnostrom, 1993) and 

white-tailed deer are considered responsible for more corn damage than any other wildlife 

species (Stewart et al., 2007). In addition to deer, substantial damage to corn by raccoons also 

has been documented (DeVault et al., 2007; Beasley and Rhodes Jr., 2008). Corn has been 

shown to constitute up to 65% of the diet of raccoons in some areas during the fall (MacGowan 

et al., 2006).

As with these larger mammals, small mammal use of cornfields for shelter and forage also varies 

regionally and includes (Stallman and Best, 1996; Sterner et al., 2003; Smith, 2005):

• Deer mouse (Peromyscus maniculatus);

• House mouse (Mus musculus);

• Meadow vole (Microtus pennsylvanicus); and

• Thirteen-lined ground squirrel (Spermophilus tridecemlineatus).

The deer mouse is commonly found in agricultural fields (Stallman and Best, 1996; Illinois, 

2000; Sterner et al., 2003). Deer mice feed on a wide variety of plant and animal matter 

depending on availability, but primarily feed on seeds and insects. Deer mice have been 

considered beneficial in agro-ecosystems because they consume both weed and insect pests 

(Smith, 2005). The house mouse is primarily a seed and grain feeder, commonly found in the 

weedy edges of reduced tillage fields (Illinois, 2000). Most crop damage by this mouse is done 

between planting and crop emergence (Illinois, 2000).

The meadow vole feeds primarily on fresh grass, sedges, and herbs, and also on seeds and grains 

of field crops. Although the meadow vole may be considered beneficial for its role in the 

consumption of weeds, the vole can be a substantial agricultural pest where abundant and when it 

consumes corn seeds in the field. The vole is often associated with the field edges where cover is 

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found off the field as well as where limited tillage agriculture and strip crops are found (Smith, 

2005). The lined ground squirrel feeds primarily on seeds of weeds and available crops, such as 

corn and wheat. This species has the potential to damage agricultural crops, although like the 

meadow vole, it also can be considered beneficial when eating pest insects, such as grasshoppers 

and cutworms (Smith, 2005).

2.4.1.2 Invertebrates

As noted in Subsection 2.4.1.1 – Birds and Mammals, common agricultural practices, 

particularly monoculture cultivation, may reduce diversity in managed fields. This net 

reduction in species is not limited to birds and mammals; invertebrates are also affected

(Landis et al., 2005). In spite of this, the invertebrate community in cornfields represents a 

diverse assemblage of feeding strategies (Stevenson et al., 2002). Numerous insects and 

related arthropods may perform valuable functions: they pollinate plants, contribute to the 

decay and processing of organic matter, reduce weed populations, and cycle soil nutrients.

Arthropods may also feed upon insects and mites that are considered to be pests (Ruiz et al., 

2008). Some of these beneficial predatory species include the convergent lady beetle 

(Hippodamia convergens), carabid beetles (Family Carabidae), parasitoids 

(e.g., Macrocentrus cingulum), and the predatory mite (Phytoseiulus persimilis) (Shelton, 

2011).

The most agronomically-relevant invertebrates in corn production fields are those 

arthropods that feed on corn plants and adversely affect grain yield. These include 

lepidopteran species that feed on the corn ear or stalk and coleopteran species that feed on 

other corn vegetative structures. Major lepidopteran and coleopteran insect pests in the 

United States include European corn borer and western corn rootworm, respectively. The 

European corn borer is present in every corn growing state except Arizona, California, 

Idaho, Nevada, Oregon, Utah, and Washington (ISU, 2012). Western corn rootworm has 

been reported as active in every corn growing state, with the exceptions of California, 

Florida, Louisiana, Nevada, Oregon and Washington (Edwards and Kiss, 2012). In the 

United States, monetary losses and expenses related to European corn borer and corn 

rootworm exceed $1 billion/year for each pest (Ostlie et al., 2002; Gray et al., 2009). As 

noted in Subsection 2.2.2.3 – Agronomic Inputs, the advent of GE Bt corn targeting these 

major insect pests has enabled a reduction in input costs by decreasing the number and 

volume of broad-spectrum insecticide application in U.S. corn cultivation (Brookes and 

Barfoot, 2010; Benbrook, 2012).

Although Bt corn has proven successful in controlling targeted insect pests since their 

introduction in 1996, there have been several reports of resistance by target pests in the United 

States, India, and South Africa (Tabashnik and Gould, 2012). For example, Gassmann (2011)

reported pockets of corn rootworm resistance to one type of Bt corn in several locations in Iowa 

(Gassmann et al., 2011); and the US-EPA has confirmed resistance to Cry1F to Fall armyworm 

in Puerto Rico (US-EPA, 2010b; Storer et al., 2012). In both the Iowa and the Puerto Rico 

reports, these resistant populations were associated with fields where growers had cultivated 

consecutive years of corn expressing the same Cry protein. The emergence of these resistant 

populations has been attributed to the grower’s failure to adhere to the refuge strategy (see, e.g., 

Storer et al., 2012). 

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As a condition of Bt registrations by US-EPA, registrants are required to develop insect 

resistance management (IRM) programs to delay the development of insect resistance to Cry 

proteins. Examples of the limitations and conditions currently implemented for the Bt proteins in 

corn can be found in the EPA document, Terms and Conditions for Bt Corn Registrations (USEPA, 2010f). As part of this program, growers of traditional Bt corn products are required to 

plant a non-Bt corn refuge (US-EPA, 2010f). Such a refuge can consist of a field or a block or 

strip of non-Bt corn (US-EPA, 2010f). Recently, the US-EPA also has approved an integrated 

refuge strategy, named “refuge in a bag”, where non-Bt seeds are blended with the Bt corn 

products and planted randomly within the field (Pioneer, 2012). Successful development and 

implementation of the refuge strategy requires an understanding of the genetic foundation of 

insect pest resistance. Incipient resistance to Cry proteins has been reported in target insect pests 

before being exposed to the Cry proteins (Mahon et al., 2012). This resistance trait is considered 

a recessive allele; susceptibility to the Cry protein is considered the dominant trait (Tabashnik 

and Gould, 2012). As a recessive trait, the frequency of expression of this trait is low in an 

unexposed population (Tabashnik and Gould, 2012). However, when the same population of 

target pests is exposed to the same Cry protein over several generations, the recessive resistance 

trait allows those individuals carrying that allele to survive and reproduce, conferring the 

resistance trait to their offspring as a greater percentage of the pest population (Tabashnik and 

Gould, 2012). The refuge strategy provides non-Bt corn where susceptible target insects (e.g., 

European corn borer and/or corn rootworms) can feed, mate and reproduce without exposure to 

the Bt corn and the Cry proteins, maintaining a genetic reservoir of susceptible target pests that 

express the dominant trait (US-EPA, 2010f; Pioneer, 2012). Future mating interactions with 

these susceptible insects (i.e., those that have not been exposed to Bt proteins) with those that 

have been exposed to the Bt proteins and survived based on the resistance allele will ensure that 

Bt resistance does not become the dominant allele in the population (Pioneer, 2012). 

Despite some evidence of Bt resistance, widespread failure of control measures using Bt crops

has not been observed, in part due to IRM strategies. IRM strategies generally include 

supplemental pesticide use and the planting of refuges (Tabashnik et al., 2008). In the case of Bt

corn grown in the Corn Belt, refuge acres are typically 5% to 20% of the cornfield area, 

depending on the product’s requirements (US-EPA, 2010f). Resistance management strategies, 

which are mandated by US-EPA’s terms of Bt corn product registrations (US-EPA, 2010f) have 

been developed for all Bt corn products to mitigate the risk of pest resistance and to implement 

additional measures if resistance occurs.

2.4.2 Plant Communities

2.4.2.1 Surrounding Landscapes and Other Vegetation in Cornfields

Cornfields may be bordered by other field crops or by woodlands, hedgerows, rangelands, or 

pasture/grassland areas. These surrounding plant communities may occur naturally or they may 

be managed for the control of soil and wind erosion. The vegetation adjacent to a cornfield is 

often dependent on the geographic region where the corn is planted.

Corn generally is cultivated as a monoculture (Dale et al., 2010). Members of the plant 

community that adversely affect corn cultivation may be characterized as weeds. The types of 

weeds in and around a cornfield depend on the local landscape in which the corn is planted (IPM, 

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2004 2007; IPM, 2007; University of California, 2009; Purdue, 2011). Some of the most 

common weeds in cornfields located in North Central Region of the United States include

(Purdue, 2012):

• Giant foxtail (Setaria faberi);

• Giant ragweed (Ambrosia trifida);

• Velvetleaf (Abutilon theophrasti);

• Common lambsquarters (Chenopodium album);

• Common ragweed (Ambrosia artemisiifolia);

• Common cocklebur (Xanthium pensylvanicum);

• Canada thistle (Cirsium arvense);

• Johnsongrass (Sorghum halepense);

• Fall panicum (Panicum dichotomiflorum); and 

• Marestail (Conyza canadensis). 

New weeds emerge as cropping practices change and growers fail to recognize or properly 

identify a plant as a weed (Iowa State University Extension, 2003). For example, in addition to 

the common weeds listed above, the Iowa State University Extension office has listed the 

following as “Weeds to Watch: New Weed Threats for Corn and Soybean Fields” (Iowa State 

University Extension, 2003): 

• Cressleaf groundsel (Senecio glabellus);

• Purple deadnettle (Lamium purpureum);

• Biennial wormwood (Artemisia biennis);

• Asiatic dayflower (Commelina communis);

• Hophornbeam copperleaf (Acalypha ostryfolia);

• Burcucumber (Sicyos angulatus);

• Wild buckwheat (Polygonum convolvulus);

• Kochia (Kochia scoparia);

• Waterhemp (Amaranthus rudis);

• Palmer amaranth (Amaranthus palmeri);

• Star-of-Bethlehem (Ornithogalum umbellatum);

• White campion (Silene latifolia);

• Wild four o' clock (Mirabilis nyctaginea); and 

• Pokeweed (Phytolacca americana). 

Weed control is an important aspect of corn cultivation. Weed control typically involves an 

integrated approach that includes timely applications of herbicide, crop rotation, weed 

surveillance, and weed monitoring (Farnham, 2001; IPM, 2004; IPM, 2007; Hartzler, 2008; 

University of California, 2009). Data have been collected on weed population densities by 

species, crop yield, and crop production system economics with the intent of providing growers 

with insights into the sustainability and profitability of diversified weed management programs 

(Shaw et al., 2011). To assist growers in managing weeds, individual states, typically through 

their state agricultural extension service, list the prevalent weeds in corn crops in their area and 

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the most effective means for their control (see, e.g., IPM, 2004; IPM, 2007; University of 

California, 2009).

Overreliance on a single weed management strategy, for example, a single MOA herbicide 

application, can cause intense selection pressure on weed populations. In this context, selection 

pressure is the extent to which organisms possessing a particular characteristic are either 

eliminated or favored by environmental conditions (Vencill et al., 2012). This strong selection 

pressure can result in ecological shifts in the weed community or the evolution of herbicideresistant biotypes (Shaw et al., 2011; Wilson et al., 2011; Vencill et al., 2012). Ecological shifts 

in the weed community may result in the selection of weeds that have an inherent resistance19 to 

an herbicide MOA; whereas the development of herbicide resistance20 in a population usually 

relies on the appearance and maintenance of herbicide-resistant alleles in a population (Vencill et 

al., 2012).

The emergence of herbicide resistance is not limited to any one herbicide or production system

(Heap, 2012). However, as described in Subsection 2.2.2.3 – Agronomic Inputs, large-scale 

adoption of GE herbicide-resistant corn varieties (e.g., glyphosate-resistant corn) has resulted in 

changes in herbicide use patterns, culminating with the use of glyphosate as the primary means 

of weed control on the majority of U.S. cornfields. Tables 2-3 through 2-5 list those weedy 

species which have been identified as herbicide-resistant to glyphosate, as well as glufosinate

and atrazine, in at least some part of their range. These three herbicides are listed to illustrate the 

differences between glyphosate and atrazine, the two most commonly used corn herbicides, and 

glufosinate, a less commonly applied product to which some GE corn varieties (e.g., 1507, 

59122, and 1507 x 59122 Maize) are resistant. The emergence of herbicide resistance presents 

continued challenges to growers to understand which herbicide-resistant species are present and 

the best agronomic practice available to manage the herbicide-resistant weed.

Table 2-3. U.S. glyphosate-resistant (G/9) weeds through July 2012.

System Scientific Name Common Name Year Identified

Weeds identified outside of 

Roundup Ready® Systems

Lolium rigidum Rigid Ryegrass 1998

Conyza bonariensis Hairy Fleabane 2003

Weeds identified in Roundup 

Ready® Systems

Poa annua Annual Bluegrass 2010

Kochia scoparia Kochia 2007

Ambrosia artemisiifolia Common Ragweed 2004

Ambrosia trifida Giant Ragweed 2004

Eleusine indica Goosegrass 2010

Conyza canadensis Horseweed, Marestail 2000

Amaranthus palmeri Palmer Amaranth 2005

Amaranthus rudis Common Waterhemp 2005

Lolium multiflorum1 Italian Ryegrass 2001

Echinochloa colona Junglerice 2008

19 In the context of weeds, tolerance is defined by the Weed Science Society of America (WSSA) as, ‘‘the inherent 

ability of a species to survive and reproduce after herbicide treatment. This implies that there was no selection or 

genetic manipulation to make the plant tolerant; it is naturally tolerant.’’

20 In the context of weeds, resistance is defined by the WSSA as, “the inherited ability of a plant to survive and 

reproduce following exposure to a dose of herbicide normally lethal to the wild type.”

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System Scientific Name Common Name Year Identified

Sorghum halepense Johnsongrass 2005

Source: (Heap, 2012)

As noted in Table 2-5, Italian Ryegrass resistant to both glyphosate and glufosinate has been identified in Oregon.

Table 2-4. Photosystem II inhibitor-resistant* (C/1) weeds through July 2012.

Scientific Name Common Name Year Identified

Abutilon theophrasti Velvetleaf 1984

Amaranthus hybridus Smooth Pigweed 1972

Amaranthus palmeri Palmer Amaranth 1993

Amaranthus powellii Powell Amaranth 1977

Amaranthus retroflexus Redroot Pigweed 1980

Amaranthus tuberculatus (syn. 

rudis)

Common Waterhemp 1994

Ambrosia artemisiifolia Common Ragweed 1976

Atriplex patula Spreading Orach 1980

Capsella bursa-pastoris Shepherd's-purse 1984

Chenopodium album Lambsquarters 1973

Chenopodium strictum var. 

glaucophyllum

Late Flowering Goosefoot 1976

Chloris inflate Swollen Fingergrass 1987

Conyza canadensis Horseweed 1981

Datura stramonium Jimsonweed 1992

Echinochloa crus-galli Barnyardgrass 1978

Eleusine indica Goosegrass 2003

Kochia scoparia Kochia 1976

Poa annua Annual Bluegrass 1978

Polygonum pensylvanicum Pennsylvania Smartweed 1990

Polygonum persicaria Ladysthumb 1980

Portulaca oleracea Common Purslane 1991

Senecio vulgaris Common Groundsel 1970

Setaria faberi Giant Foxtail 1984

Setaria glauca Yellow Foxtail (glauca) 1981

Solanum ptycanthum Eastern Black Nightshade 2004

Source: (Heap, 2012)

*Atrazine is a photosystem II inhibitor.

Table 2-5. U.S. glutamine synthase inhibitor1 (H/10) weeds through July 2012.

Scientific Name Common Name Year Identified

Lolium multiflorum2 Italian Ryegrass 2010

Source: (Heap, 2012)

Notes:

1. Glufosinate is a glutamine synthase inhibitor

2. Italian Ryegrass also is resistant to glyphosate. In 2012, Heap notes that Italian Ryegrass was found in Oregon at 2 to 5 sites, between

51 and 100 acres, demonstrating multiple resistance.

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2.4.2.2 Corn as a Weed or Volunteer

In the United States, corn is not listed as a weed (Crockett, 1977; Muenscher, 1980), nor is it 

present in the Federal Noxious Weed List (7 CFR Part 36021) (USDA-NRCS, 2011a; USDANRCS, 2012a). Furthermore, corn is grown throughout the world without any report that it is a 

serious weed or that it forms persistent feral populations (Gould, 1968; OECD, 2003), because 

corn possesses few of the characteristics of those plants that are notably successful as weeds 

(Baker, 1965; Keeler, 1989). However, corn seed from a previous year’s crop can overwinter and 

germinate the following year in a field, similar to other domesticated crops. Manual or chemical 

measures are often applied to remove these volunteers. The plants that are not removed do not 

typically result in feral populations in following years because maize is incapable of sustained 

reproduction outside of domestic cultivation (Gould, 1968). 

Corn periodically occurs as a volunteer when corn seeds remain in the field after harvest and 

successfully germinate (Beckett and Stoller, 1988; USDA-APHIS, 2012e) (see also Davis, 2009; 

Hager, 2009; Bernards et al., 2010; Johnson et al., 2010; Wilson et al., 2010; Stewart, 2011; 

Wilson, 2011). Post-harvest seed residues in fields can be a result of harvester inefficiency, bird 

dispersal or seed drop, with the seed ending up beyond the field margins or remaining as residues 

in the field after the harvest (Davis, 2009). This can be a particular problem when weather late in 

the season causes ears to drop or lodging to occur, which places the ears on the ground where the 

seeds then germinate the following year (Wilson et al., 2010). Volunteer corn can be present as 

single plants or as clumps formed when an ear drops to the ground and is partially buried (Davis, 

2009; Wilson et al., 2010). When those seeds survive to the subsequent growing season, 

volunteer plants may develop within subsequent crops or outside of the cropped area. The 

potential for corn, including GE corn, to establish as a volunteer has been the subject of recent 

research, with a particular emphasis on yield impact and management of herbicide-resistant corn 

as a volunteer in subsequent crops modified for resistance to the same herbicide (Beckett and 

Stoller, 1988; Beckie and Owen, 2007; Davis, 2009; Wilson et al., 2010; Wilson, 2011).

Corn volunteers are limited by the geography in which they initially are planted. Corn is an 

annual plant, and cannot survive temperatures below 0 °C for more than 6 to 8 hours when the 

growing point is above ground; however, corn seeds which are incorporated in the soil during 

harvest or in fall tillage may overwinter and grow the following spring (OECD, 2003; Stewart, 

2011). Volunteer corn lacks vigor and competitiveness because the volunteer plant is two 

generations removed from the cross which produced the hybrid planted (Davis, 2009). GE corn 

may be a problematic volunteer the year after harvest in field crops grown in rotation with corn, 

especially soybean, dry beans, sugar beets, as well as subsequent corn crops (Davis, 2009; 

Hager, 2009; Bernards et al., 2010; Johnson et al., 2010; Wilson et al., 2010; Stewart, 2011; 

Wilson, 2011). For example, the presence of volunteer corn in soybeans was identified in 12% of 

the soybean acreage in Illinois in a 2005 survey of soybean acreage in corn – soybean rotation 

systems (Davis, 2009), and a 2010 survey of soybean cultivation in Illinois identified a field with 

up to 500,000 volunteer corn plants per acre (Hager, 2010). 

21 http://www.aphis.usda.gov/plant_health/plant_pest_info/weeds/downloads/weedlist-2010doc.pdf

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Volunteer corn competes with the intended crop for light, soil moisture, and nutrients (Soltani et 

al., 2006; Bernards et al., 2010; Wilson et al., 2010). The effect of volunteer corn on the yields of 

the intended crop depends on the density of the volunteer corn (Davis, 2009; Bernards et al., 

2010; Jeschke and Doerge, 2010). In controlled agronomic studies, an analysis of yield impacts 

to soybeans from volunteer corn was evaluated at densities up to 17,800 corn plants per acre of 

soybean (Alms et al., 2007; Alms et al., 2008). In these controlled studies, volunteer corn 

densities ranging from zero plants per square meter up to 4.4 plants per square meter were 

cultivated in soybean, with corresponding soybean yield losses of up to 58% (Alms et al., 2007; 

Alms et al., 2008). Pre-harvest herbicide treatments of the volunteer corn reduced but did not 

eliminate the yield impacts. In experimental studies, volunteer corn in soybeans was controlled 

using different application rates of the herbicide clethodim in the attempt to better quantify 

soybean yield loss (Alms et al., 2008). Clethodim treatments of the volunteer corn did reduce the 

volunteer corn density, although even after a 98% control of the volunteer corn, soybean yield 

still suffered a 5% reduction in yield (Alms et al., 2008).

Successful control of corn volunteers, including herbicide-resistant varieties, is accomplished 

with the use of various combinations of cultivation practices and herbicides (Beckett and Stoller, 

1988; Beckie and Owen, 2007; Sandell et al., 2009; Jeschke and Doerge, 2010). Volunteer corn 

is less of a concern in no-till fields than in fall-tilled fields because of the lower probability that 

corn seed will survive and germinate in the following growing season (Bernards et al., 2010). In 

no-till fields, the fallen corn is frequently eaten by wildlife and also is subject to winter weather 

conditions (Bernards et al., 2010). In fall tillage systems, corn seed may be buried in the soil and 

overwinter. Volunteer corn which has emerged from this overwintered seed requires control with 

spring tillage or with an application of herbicides (Bernards et al., 2010).

Volunteer corn also can be problematic in fields where the grower elects to cultivate corn after 

corn. Such volunteer corn in cornfields can be controlled using inter-row cultivation and several 

different herbicides (Minnesota, 2009; Sandell et al., 2009). As noted with volunteer corn in 

soybean, growers can take advantage of alternate modes of herbicide action if the herbicide 

resistance differs between the current crop and the volunteer (e.g., glufosinate in LibertyLink®

Corn to control a glyphosate-resistant variety) (Minnesota, 2009). Pre-emergent controls might 

include Gramoxone Inteon (paraquat) mixed with Atrazine (Sandell et al., 2009; Monsanto, 

2010). When these two herbicides are used together, optimal control is observed if the 

applications are made before the corn reaches the 6-inch stage (Monsanto, 2010). If the volunteer 

corn is stacked to contain both a glyphosate- and glufosinate-resistant trait, inter-row cultivation 

is the only option for post-emergent control within corn (Sandell et al., 2009).

2.4.3 Soil Microorganisms

Microorganisms in the field may mediate both negative and positive outcomes. Diseases that 

afflict corn with substantial potential for economic loss include fungal corn rusts, corn leaf 

blights, ear smuts, ear and kernel rot fungi, and maize mosaic viruses (Cartwright et al., 2006).

Microorganisms may also play an important role in the ecology of the soil (OECD, 2003). Soil 

microorganisms play a key and beneficial role in soil structure formation, decomposition of 

organic matter, toxin removal, nutrient cycling, and most biochemical soil processes (Young and 

Ritz, 2000; Garbeva et al., 2004). Microorganisms also may suppress soil-borne plant diseases 

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DRAFT PIONEER 4114 MAIZE

and promote plant growth (Doran et al., 1996). The main factors affecting microbial population 

size and diversity include soil type (texture, structure, organic matter, aggregate stability, pH, 

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

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

and irrigation) (Young and Ritz, 2000; Garbeva et al., 2004). Plant roots release a large variety of 

compounds into the soil, creating a unique environment for microorganisms in the rhizosphere22

(Bais et al., 2006). Microbial diversity in the rhizosphere is extensive and differs from the 

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

2.4.4 Biological Diversity

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

(Wilson, 1988). Agricultural biodiversity has been defined to include genetic diversity of the 

crops through and including the natural biodiversity of the surrounding ecosystem (see, e.g., 

Carpenter, 2011). USDA-APHIS focuses its analysis of biological diversity at the ecosystem 

level, that aspect of the environment potentially impacted by the determination of nonregulated 

status of various GE crops. In this case, biodiversity refers to the ability of a highly managed 

ecosystem, such as a cornfield, to support species that do not contribute directly to crop 

production but represent important components of the biological landscape. Such species include 

those affecting pollination (e.g., bees, butterflies) and control of insect pests; important avian 

(e.g., songbirds) and mammalian (e.g., small mammals) wildlife; and the plant community.

Among other benefits, natural 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, 2000). Beneficial insects, birds, and mammals are 

natural predators of many crop pests and play an important role in pest management (USDANRCS, 2002). The loss of biodiversity results in a need for costly external inputs in order to 

provide these functions to the crop (Altieri, 1999; Altieri, 2000). 

Species diversity and abundance in corn agro-ecosystems may differ among conventional, GE, 

and organic production systems. Relative to any natural ecosystem, species abundance and 

richness will generally be less in intensively managed agro-ecosystems. The degree of 

biodiversity in an agro-ecosystem depends on four primary characteristics: 1) diversity of 

vegetation within and around the agro-ecosystem; 2) permanence of various crops within the 

system; 3) intensity of ecosystem management; and 4) extent of isolation of the agro-ecosystem 

from natural areas of native vegetation (Altieri, 1999; USDA-NRCS, 2002). Tillage, seed bed 

preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest limit habitat 

diversity resulting in a corresponding decrease in diversity of plants and animals.

22 The rhizosphere is defined as subsoil area in the root zone of plants in which plant roots compete with the 

invading root systems of neighboring plants for space, water, and mineral nutrients, and interact with soil-borne 

microorganisms, including bacteria, fungi, and insects feeding on the organic material in the soil T. S. Walker, H. P. 

Bais, E. Grotewold and J. M. Vivanco, "Root Exudation and Rhizosphere Biology," Plant physiology 132.1 (2003).. 

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Cropland management practices, including a range of practices incorporated in integrated pest 

management plans can be adopted which increase habitat preservation and plant biodiversity 

(see, e.g., IPM, 2004; IPM, 2007; Sharpe, 2010; Palmer et al., 2011).

Conservation tillage and no-till practices have a positive impact on wildlife, including the 

community of beneficial arthropods (Altieri, 1999; Landis et al., 2005; Towery and Werblow, 

2010). These benefits derive from decreased soil erosion and improved water quality in receiving 

waters, retention of cover, availability of waste grain on the soil surface for feed, and increased 

populations of predaceous invertebrates as well as invertebrates as a food source (Landis et al., 

2005; Sharpe, 2010).

Crop rotations reduce the likelihood of crop disease, insect pests, weed pests, and the need for 

pesticides (Randall et al., 2002). Reduced pesticide use has a direct positive effect on wildlife by 

reducing the direct exposure of birds, mammals, and fish to pesticides. Indirect benefits include 

less alteration of suitable wildlife habitat and an available food supply of insects for insectivores 

(Sharpe, 2010; Palmer et al., 2011). Crop rotations with legumes and small grains have been 

shown to provide excellent wildlife nesting cover, food, and brood-rearing habitat (Sharpe, 

2010). Polycultures of plants support herbivorous insect populations because they provide a 

more stable and continuous availability of food and habitat for beneficial insects (Altieri and 

Letourneau, 1982; Altieri and Letourneau, 1984; Altieri, 1999; Landis et al., 2005). 

Field edges can be managed to promote wildlife. These borders are often the least productive 

areas in a farm field and in some cases, the cost of producing crop areas along field edges 

exceeds the value of the crop produced (Sharpe, 2010). Allowing field edges to return to noncrop vegetation does contribute to weed seeds in the field, but does not contribute to major pest 

problems in the crop field itself (Sharpe, 2010). Non-crop border vegetation, such as ragweed, 

goldenrod, asters, and forbs, may quickly develop into nesting and brood habitat for quail and a 

multitude of songbirds (Sharpe, 2010). Maintaining some weeds harbors and supports beneficial 

arthropods that suppress herbivore insect pests (Altieri and Letourneau, 1982; Altieri and 

Letourneau, 1984; Altieri, 1999). Research conducted at North Carolina State University and the 

North Carolina Wildlife Resources Commission found that fields with bands of natural cover 

along ditch banks have more quail and wintering songbirds than nearby fields with closely 

mowed ditch banks(Sharpe, 2010). Adjacent wild vegetation provides alternate food and habitat 

for natural enemies to pest herbivores (Altieri and Letourneau, 1982; Altieri and Letourneau, 

1984; Altieri, 1999).

Contour-strip cropping is another management practice that can be used to promote wildlife 

habitat. This practice alternates strips of row crops with strips of solid stand crops (i.e., grasses, 

legumes, or small grains) with the strips following the contour of the land (Sharpe, 2010). The 

primary purpose of contour-strip cropping is to reduce soil erosion and water runoff, but the solid 

stand crop also provides nesting and roosting cover for wildlife (Sharpe, 2010). Grass-legume 

refuge strips also have been used to increase the population density of insectivorous carabid 

beetles in corn and soybean fields (Landis et al., 2005).

Drainage ditches, hedgerows, riparian areas, and adjacent woodlands to a cornfield also provide 

cover, nesting sites, and forage areas, which each contribute to enhancing wildlife populations.

Ditch banks, for example, function as narrow wetlands that provide nesting sites and cover, serve 

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DRAFT PIONEER 4114 MAIZE

as wildlife corridors, and provide areas for the wildlife to occupy when crop fields lack cover 

(Sharpe, 2010). Ditches have been shown to support birds, rodents, reptiles, furbearers, 

amphibians, fish, and aquatic organisms (Sharpe, 2010).

2.4.5 Gene Movement

2.4.5.1 Vertical Gene Movement

Vertical gene movement (i.e., vertical gene flow or sexual reproduction) generally involves the 

movement of alleles from parents to offspring. In corn, sexual reproduction may occur between 

domesticated corn varieties or from corn to sexually-compatible relatives.

Vertical gene flow includes the possibility of pollen transfer between different varieties of corn.

A variety of plant properties, environmental conditions, and imposed conditions can affect 

movement of genes between corn cultivars. For gene flow to occur between corn varieties, viable 

pollen must reach a receptive tassel (Lerner and Dana, 2001). This requires that flowering times 

must overlap, viable pollen transfer between the varieties must occur, embryo/seeds must 

develop, and hybrid seed must disperse and establish (see, e.g., Lerner and Dana, 2001; Diver et 

al., 2008). Spatial and temporal isolation can be one of the most effective barriers to gene 

exchange between corn crop cultivars (Mallory-Smith and Zapiola, 2008). Current practices for 

maintaining the purity of hybrid seed production in corn are typically successful for maintaining 

99% genetic purity, though higher instances of out-crossing can occur (Ireland et al., 2006). 

These practices for maintaining varietal purity are also discussed in Subsection 2.2.3 – Organic 

Corn Farming and Specialty Corn Systems.

The possibility of gene movement from the host plant into native or feral populations of Zea

species or wild or weedy relatives of corn has been evaluated by the US-EPA and determined to 

not be a concern in the continental United States (US-EPA, 2010e). The potential for outcrossing 

is defined as the likelihood of gene movement to wild corn relatives. This subsection provides a 

basis for evaluating the potential for outcrossing in corn to these wild corn varieties.

The closest relative of Zea is the genus Tripsacum (OECD, 2003). Seventeen species of 

Tripsacum have been identified, with chromosome number varying from 2n = 36 to 2n = 108 

(OECD, 2003). All of the Tripsacum species are perennial and are mostly found in Central 

America23 (OECD, 2003). However, three species have been identified in the United States: T. 

dactyloides, Eastern gamagrass, is known to occur in the eastern half of the United States, T. 

lanceolatum, Mexican gamagrass, occurs in the southwest of the United States, and T. 

floridanum, Florida gamagrass, is native to South Florida and Cuba (Wozniak, 2002; OECD, 

2003). T. dactyloides is the only Tripsacum species of widespread occurrence and agricultural 

importance in the United States, and commonly is grown as a forage grass (Wozniak, 2002).

Distinctions in genetic construct between related species are important to recognize, as the 

genetic differences directly affect the ability of cultivated corn to interbreed with wild relatives. 

23 For example, Tripsacum may be found in Central Mexico, Belize, Guatemala, El Salvador, Honduras, Nicaragua 

and Costa Rica.

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DRAFT PIONEER 4114 MAIZE

Tripsacum differs from corn in many respects, including chromosome number (T. dactyloides n 

= 18; Z. mays n = 10) (Wozniak, 2002). The three Tripsacum species in the United States exhibit 

several ploidy types. T. floridanum has a diploid chromosome number of 2n = 36 (Wozniak, 

2002). T. dactyloides includes 2n = 36 forms which are native to the central and western United 

States, and 2n = 72 forms which extend along the Eastern seaboard and along the Gulf Coast 

from Florida to Texas, but which also have been found in Illinois and Kansas (Wozniak, 2002).

T. lanceolatum has a diploid number 2n = 72 (Wozniak, 2002). The potential for pollen-directed 

gene flow from maize to Eastern gamagrass is remote (Wozniak, 2002). Although hybridization 

of Tripsacum x Z. mays has been accomplished in the laboratory using special techniques under 

highly controlled conditions, these hybrids have not been observed in the field (Wozniak, 2002).

Additionally, Tripsacum does not represent any species considered a serious or pernicious weed 

in the United States or its territories (Wozniak, 2002). Any introgression of corn genes into this 

species as a result of cross fertilization is not expected to result in a species that is weedy or 

difficult to control (Wozniak, 2002). Hybrids between Z. mays and the teosinte subspecies Z. 

mays subsp. mexicana are known to occur when the two are sympatric in Mexico (CEC, 2004; 

Ellstrand et al., 2007a). Many species of Tripsacum can cross with Zea, or at least some 

accessions of each species can cross, but only with difficulty and the resulting hybrids are 

primarily male and female sterile (Wozniak, 2002). The rate at which crop genes enter teosinte 

populations may be limited by genetic barriers, phenological differences, and subsequently by 

the relative fitness of the hybrids (CEC, 2004; Ellstrand et al., 2007a).

2.4.5.2 Horizontal Gene Movement

Horizontal gene movement (i.e., horizontal gene transfer) and consequent expression of 

deoxyribonucleic acid (DNA) from a plant species to bacteria, is unlikely to occur (Keese, 2008).

Many bacteria (or parts thereof) that are closely associated with plants have been sequenced, 

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

2002). There is no evidence that these organisms contain genes derived from plants. In cases 

where the review of sequence data implied that horizontal gene transfer occurred, these events 

were inferred to occur on an evolutionary time scale on the order of millions of years (Brown, 

2003).

2.5 PUBLIC HEALTH

2.5.1 Human Health

Since 1980, the public’s consumption of corn-based products has more than doubled. Per capita 

consumption of corn products rose from 12.9 pounds annually per capita in 1980 to 33 pounds in 

2008; and corn sweeteners increased from 35.3 pounds annually per capita to 69.2 pounds during 

that period (USCB, 2011). As of 2012, 88% of the corn cultivated is GE (USDA-NASS, 2012c). 

Human health concerns associated with the use of GE corn generally focus on human 

consumption of GE corn and products derived from GE corn. This subsection provides a 

summary of the principal human health concerns related to the consumption of GE corn. Issues 

related to farm workers or animal feed are presented in Subsection 2.5.2 – Worker Safety and 

Subsection 2.6 – Animal Feed, respectively. 

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DRAFT PIONEER 4114 MAIZE

Potential public health concerns from GE crops may result from two aspects of the crop: the use 

of pesticides on a crop and the potential changes in crop composition24, including exposure to the 

introduced genes/proteins. 

In general, members of the general public may be exposed to pesticides and pesticide residues 

through consumption of agricultural crops. Before a pesticide can be used on a food crop, USEPA, pursuant to the FFDCA, must establish a tolerance value representing the maximum 

pesticide residue that may remain on the crop or in foods processed from that crop (21 U.S.C. 

§301, et seq. ; see also http://www.epa.gov/opp00001/regulating/tolerances.htm). Pesticide 

tolerances established by the US-EPA ensure safety of foods treated with pesticides and are 

made following risk assessments that reflect real-world consumer exposure as closely as possible 

(US-EPA, 2012e). These tolerances include traditional pesticides, such as herbicides, and genetic 

elements that may be introduced through GE processes, such as PIPs (e.g., Cry proteins) or 

proteins that confer herbicide resistance (e.g., PAT) (US-EPA, 2007a). Common corn herbicides 

and PIPs that are currently used in U.S. corn production are listed and discussed in Subsection 

2.2 – Agricultural Production of Corn. The US-FDA and the USDA monitor foods for pesticide 

residues and work with the US-EPA to enforce these tolerances (see USDA-AMS, 2011). 

Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the 

products they market are safe and labeled properly. GE organisms for food and feed may 

undergo a voluntary consultation process with the US-FDA prior to release onto the market. 

Although a voluntary process, thus far, all applicants who have wished to commercialize a GE 

crop variety that would be included in the food supply have completed a consultation with the

US-FDA. In such 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 US-FDA a summary of its scientific 

and regulatory assessment of the food. This process includes: 1) an evaluation of the amino acid 

sequence introduced into the food crop to confirm whether the protein is related to known toxins 

and allergens; 2) an assessment of the protein’s potential for digestion; and 3) an evaluation of 

the history of safe use of the protein in food (Hammond and Jez, 2011). US-FDA evaluates the 

submission and responds to the developer by letter with any concerns it may have or additional 

information it may require. Several international agencies also review food safety associated 

with GE-derived food items, including the EFSA and the Australia and New Zealand Food 

Standards Agency (ANZFS).

Additionally, foods derived from biotechnology also undergo a comprehensive safety evaluation 

before entering the market, including reviews under the CODEX, the European Food Safety 

Agency, and the World Health Organization (FAO, 2009; Hammond and Jez, 2011). Food safety 

reviews frequently will compare the compositional characteristics of the GE crop with nontransgenic, conventional varieties of that crop (see also Aumaitre et al., 2002; FAO, 2009). 

Moreover, this comparison also evaluates the composition of the modified crop under actual 

24 As determined by the OECD Consensus Document on Compositional Considerations for New Varieties of Maize 

(Zea mays): Key Food and Feed Nutrients, Anti-Nutrients and Secondary Plant Metabolites.

http://www.oecd.org/science/biosafety-biotrack/46815196.pdf. Last accessed August 27, 2012.

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DRAFT PIONEER 4114 MAIZE

agronomic conditions, including various agronomic inputs (see, e.g., Pioneer Petition, , 2011b). 

Composition characteristics evaluated in these comparative tests include moisture, protein, fat, 

carbohydrates, ash, minerals, dietary fiber, essential and non-essential amino acids, fatty acids, 

vitamins, and anti-nutrients (OECD, 2002; Pioneer, 2011b). 

Comparison of anti-nutrients represents an important element of this comparison. Anti-nutrients 

are naturally-occurring compounds produced by a plant which interfere with the absorption and 

metabolism of the consumed crop as well as other foods in the digestive tract (Cordain, 1999). 

Anti-nutrients in corn include raffinose, phytic acid and trypsin inhibitor (OECD, 2002). 

Raffinose is a low molecular weight oligosaccharide that is non-digestible, causing flatulence 

from consumption (OECD, 2002). Phytic acid chelates mineral nutrients rendering them 

unavailable to monogastric animals (OECD, 2002; Pioneer, 2011b). Trypsin inhibitors inhibit 

protein digestion (Cordain, 1999). 

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

changes arise with all forms of genetic modification, including both conventional hybridizing 

and GE (NRC, 2004). The NRC also noted in its 2004 report that no adverse human health 

effects attributed to GE had been documented. More recently, the NRC found that the cultivation 

of GE crops has resulted in improvements of pesticide application regimens (applications of 

fewer pesticides or using pesticides with lower environmental toxicity), and that the cultivation 

of herbicide-resistant crops was advantageous because of their efficacy in pest control and 

concomitant economic, environmental, and presumed personal health advantages (NRC, 2010). 

Reviews on the nutritional quality of GE foods generally have generally concluded that there are 

no biologically meaningful nutritional differences between conventional and GE plants for food 

or animal feed (Aumaitre et al., 2002; Faust, 2004; Van Deynze et al., 2004). 

The nutritional content of corn may also be affected by corn pests and diseases. For example, 

mycotoxins are chemicals that are produced by fungi and that are toxic or carcinogenic to 

animals and humans (US-EPA, 2010b). The most common mycotoxin in corn is the class of 

compounds called fumonisins, produced as a result of infections by the fungal genus Fusarium 

(Munkvold and Hellmich, 2000; US-EPA, 2010b). Another class of mycotoxins in corn is the 

aflatoxins, produced by the genus Aspergillus (Munkvold and Hellmich, 1999). Injury by insect 

pests can be an important factor in mycotoxin development in corn. Insect pests promote the 

growth of mycotoxin-producing fungi by creating entry wounds on the kernels and carrying 

fungal spores from the plant surface to damaged kernels (Munkvold and Hellmich, 1999; 

Munkvold and Hellmich, 2000). By reducing insect predation and kernel damage, the 

incorporation of Bt in corn has been shown to reduce contamination by the mycotoxin fumonisin 

(Munkvold and Hellmich, 1999). 

2.5.2 Worker Safety

Worker hazards in farming are common to all types of agricultural production, and include 

hazards of machinery and common agricultural management practices. A common agricultural 

practice, pesticide application, represents the primary exposure route to pesticides for farm 

workers. Pesticides, including herbicides, are used on most corn acreage in the United States 

(Pioneer, 2012). Changes in acreage, crops, or farming practices may affect the amounts and 

types of pesticides used, and thus, the risks to workers. 

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DRAFT PIONEER 4114 MAIZE

As discussed in Subsection 1.3 – Coordinated Framework Review and Regulatory Review, all 

pesticides labeled for use on crops in the United States must first be registered by the US-EPA.

Among other elements, the US-EPA pesticide registration process involves the design of use 

restrictions that, when followed, have been determined to be protective of worker health.

Worker safety precautions and use restrictions are noted clearly on pesticide registration labels. 

These restrictions provide instructions as to the appropriate levels of personal protection required 

for agricultural workers to use herbicides. These may include instructions on personal protective 

equipment, specific handling requirements, and field reentry procedures (Bayer, 2012). When 

used in accordance with the label, one corn herbicide, glufosinate, has been determined to not 

present a health risk to workers (US-EPA, 2008b). 

EPA’s Worker Protection Standard (WPS) (40 CFR Part 170) was published in 1992 to require 

actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and 

pesticide handlers. The WPS offers protections to more than two and a half million agricultural 

workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, 

and greenhouses. The WPS contains requirements for pesticide safety training, notification of 

pesticide applications, use of personal protective equipment, restricted entry intervals following 

pesticide application, decontamination supplies, and emergency medical assistance. 

2.6 ANIMAL FEED

Corn comprises more than 95% of the total U.S. feed grain production (USDA-ERS, 2012d). 

Corn is valuable as a feed because of its composition, including key nutrients and secondary 

metabolites, protein content, fiber, among others (OECD, 2002). Corn grain is used for feed for 

beef cattle, poultry, hogs and dairy cattle, with beef cattle consuming the largest volume 

harvested (NCGA, 2009). Animal feed derived from corn comes not only from the unprocessed 

grain, but also from silage, the above-ground portions of the corn plant, and stalk residues in 

fields that might be grazed (OECD, 2002). Processed product residuals derived from additional 

major corn industries such as corn refining, corn dry millers, and distillers also are used as 

animal feed (CRA, 2006). Animal feed products from corn refining and wet milling include corn 

gluten feed, corn gluten meal, corn germ meal, corn steep liquor, and amino acids (CRA, 2006). 

In addition to direct feeding of corn grain, many corn-based animal feed products are derived 

from other processes involving chemical or mechanical processing. For example, corn gluten 

feed is the residue remaining after the extraction of starch, gluten, and germ (CRA, 2006). Corn 

gluten feed is considered a medium protein product and is used widely in complete animal feeds 

for dairy and beef cattle, poultry, and hogs (CRA, 2006). Corn gluten meal is a high-protein 

ingredient consisting of corn proteins separated in the milling process, and may contain as much 

as 60% protein (CRA, 2006). The high protein content also is valued as a cattle feed to protect 

the cow’s rumen (CRA, 2006). Corn germ meal is a residual product obtained from the corn 

germ after the corn oil has been extracted (CRA, 2006). Corn germ meal is a small fraction of the 

corn kernel, and has a small market in animal feed as a carrier for liquid nutrients (CRA, 2006). 

Corn steep liquor is a high protein product comprised of the soluble portions of the corn kernel 

removed during the corn steep process (CRA, 2006). Corn steep liquor is sometimes combined 

with other ingredients in corn gluten feed or provided as a liquid protein source (CRA, 2006). 

Amino acids are produced through the fermentation of corn-derived dextrose (CRA, 2006). 

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DRAFT PIONEER 4114 MAIZE

Lysine, an essential animal amino acid, is a highly valued corn-derived amino acid for both 

poultry and swine (CRA, 2006). Threonine and tryptophan amino acid feed supplements also are 

produced from corn (CRA, 2006).

Public concern for animal feed and GE crops generally relates to two aspects of the crop: the use 

of a pesticide on the crop; and the potential changes in crop composition, including genes or 

proteins associated with the introduced trait. For pesticides and pesticide residues, US-EPA

generally establishes animal feed tolerances at the same time as the tolerances for food

(http://www.epa.gov/pesticides/bluebook/chapter11.html). Similar to tolerance values for food, 

these US-EPA tolerance values for feed are set to ensure safety of raw or processed commodities 

for animal feed and may include conventional pesticides (e.g., herbicides) and genetic elements 

resulting from genetic engineering, such as PIPs (e.g., Cry proteins) or proteins conferring 

herbicide resistance (e.g., PAT protein) (US-EPA, 2012e).

2.7 SOCIOECONOMIC 

Corn is produced for food and feed commodities as well as industrial uses (USDA-ERS, 2012d). 

Corn is the most widely cultivated feed grain in the United States, accounting for more than 95% 

of total value and production of feed grains (James, 2009; USDA-ERS, 2011d; USDA-ERS, 

2012d). Corn is grown in all 48 states of the continental United States, with production 

concentrated in the Corn Belt. The U.S. Corn Belt is loosely defined as the states of Illinois, 

Iowa, Indiana, the eastern portions of South Dakota and Nebraska, western Kentucky and Ohio, 

and the northern two-thirds of Missouri. Iowa and Illinois are the two top corn producing states 

and typically account for more than one-third of the total U.S. crop (USDA-ERS, 2012d; USDANASS, 2012b).

2.7.1 Domestic Economic Environment

In the 2012 production year, corn was cultivated in the United States on over 96 million acres, a 

5% increase in corn acreage from 2011(USDA-NASS, 2012b). Corn production in 2011 was 

estimated at 12.44 billion bushels and valued at an estimated $5.15 to $5.65 per bushel. This 

resulted in a total value of approximately $64.1 – 70.3 billion for 2011. In 2012, production was 

estimated at 12.38 billion bushels (USDA-NASS, 2012c). However, because of severe drought 

throughout the Corn Belt, the estimates for corn production in 2012 were projected sharply 

lower. In August, 2012, the season average farm price for corn was projected at $7.50 to $8.90 

per bushel, a 39% increase in price from the previous month and a 58% average increase over 

2011 (USDA-OCE, 2012b). 

The cultivation of corn for animal feed varies depending upon the demand in the livestock 

industry (USDA-ERS, 2012d). Direct feeding of corn to livestock has declined in response to 

declines in meat production since 2007 in the United States, as has the use of certain corn byproducts for livestock feeds (USDA-OCE, 2012b). The production of ethanol generates several 

economically valuable co-products for animal feed, including distillers dried grains with solubles 

(DDGs) (USDA-ERS, 2012d). Each 56-pound bushel of corn used in dry mill ethanol production 

generates approximately 17.4 pounds of DDGs which are fed to livestock (USDA-ERS, 2011d). 

Food and industrial use of corn (other than for ethanol production) is projected to increase, 

although this demand also is related to specific products (USDA-OCE, 2012b). Demand for 

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DRAFT PIONEER 4114 MAIZE

high-fructose corn syrup (HFCS), glucose and dextrose is expected to increase, but at lower rates 

than in previous years. Corn starch is considered an industrial product, the production of which is 

contingent on industrial demand (USDA-OCE, 2011; USDA-OCE, 2012b).

Gross value of production on a typical U.S. corn farm in 2011 was approximately $837/acre 

(USDA-ERS, 2012b). However, this does not take into associated production costs, such as 

operating costs and allocated overhead costs. In general, operating costs represented 40%

($332/acre) of corn farm gross income and may include expenses related to seed purchases, 

agronomic inputs (e.g., fertilizers, irrigation, and pesticides), and the maintenance of farm 

equipment. Allocated overhead costs, on the other hand, represented approximately 34%

($284/acre) of corn farm gross income and include expenses related to labor, acquisition of 

farming equipment, land rental rates, taxes, and insurance premiums. In total, net profit of a 

typical U.S. corn farm, minus operating and overhead costs, was $221/acre in 2011 (USDA-ERS, 

2012b).

The costs for GE corn seed are higher than that for non-GE seed. Growers pay a premium for GE 

seed, with growers in 2008 paying as much as 50% more for GE corn seed than conventional 

seed (NRC, 2010). This seed premium includes a technology fee for the cultivation of the seed 

(NRC, 2010). This seed premium also reflects the increased value offered by the seed. For 

example, a consumer buying a corn variety containing a Cry protein (e.g., 1507, 59122, or 1507 

x 59122 Maize) is purchasing both the corn seed and an insecticide combined in a single product 

(NRC, 2010).

Despite the increased cost of GE corn seed, total farm operating costs are often offset by 

improved grain yield and reduced corn production costs. These production cost reductions may 

be a result of increased yields, reductions in average herbicide and pesticide use per field, and 

corresponding reductions in tillage and associated field cultivation costs (Carpenter et al., 2002).

Fuels and chemicals are each estimated to comprise approximately 5% of farm production 

expenses (USDA-NASS, 2009). Other benefits to the grower from adoption of GE corn have 

included (Carpenter et al., 2002; Brookes and Barfoot, 2010):

• Increased management flexibility and convenience arising from the ease of use of broadspectrum herbicides like glyphosate;

• A decrease in “knock-back” of the crop associated with post-emergent applications of 

herbicides on the herbicide-resistant crop;

• Reduced harvesting costs;

• Higher quality harvested crop;

• An improvement in soil quality as growers reduce quantities of soil-applied herbicides 

and increase limited tillage; and

• Overall improvements in human health costs associated with use of less toxic products.

Herbicide-resistant corn has been cultivated commercially since 1997. The cultivation of this 

crop has reduced costs and increased profitability, with average grower profitability improved by 

$20/hectare to $25/hectare in most years when compared with the costs of conventional 

herbicide treatment used to gain the same level of control in a low/reduced till system (Brookes 

and Barfoot, 2010). These economic benefits are influenced by the comparative cost of the 

herbicides. For example, in 2007, the manufacturers of glyphosate posted a substantial increase 

46
DRAFT PIONEER 4114 MAIZE

in price, resulting in reduced average profitability of $17.60/hectare (Brookes and Barfoot, 

2010).

The primary economic benefit of the adoption of Bt corn derives from the avoidance of pesticide 

applications and the associated increase in yield (see, e.g., Fernandez-Cornejo and Caswell, 

2006; Brookes and Barfoot, 2012). Cost savings to the grower include less time spent scouting 

the crop for pests and savings in machinery use (Brookes and Barfoot, 2012).

The incorporation of Bt in corn has a secondary economic benefit to growers by reducing 

contamination by mycotoxins. Corn that contains mycotoxins above a certain level is more likely 

to be rejected in the market, forcing growers to accept the lower price for non-food uses (USEPA, 2010b). The costs of mycotoxins in the United States commodity market have been 

estimated as high as $5 billion/year (Schmale III and Munkvold, 2012). 

The emergence of glyphosate-resistant weed biotypes has been identified as an economic 

concern (NRC, 2010). Glyphosate resistance has been demonstrated to reduce the effectiveness 

and economic benefits of glyphosate-resistant crop systems (Weirich et al., 2011). To manage 

these resistant weeds, growers generally increased herbicide application rates, increased the 

number of herbicide applications, and returned to more traditional tillage practices. Economic 

impacts of glyphosate-resistant weeds are a direct result of increased inputs: additional 

herbicides are required to control the resistant weeds; fuel costs increase as heavy equipment is 

used more frequently in the field for chemical application and tillage; and tillage, labor, and 

management hours increase in association with the application of additional herbicides and 

machinery use (NRC, 2010; Weirich et al., 2011). There also is an additional cost from the 

reduction in yield associated with the competition of the crop and the glyphosate-resistant weeds 

(NRC, 2010; Weirich et al., 2011).

2.7.2 Trade Economic Environment

Corn is the dominant feed grain traded internationally (James, 2009; USDA-OCE, 2011; USDAOCE, 2012a; USDA-OCE, 2012b; USDA-OCE, 2012c). In 2011/2012, the United States 

produced approximately 36% of the total world supply of corn (USDA-OCE, 2012b). Corn is 

cultivated worldwide, including Argentina, South Africa, Brazil, Canada, China, and former 

Soviet Union States, including the Ukraine (USDA-OCE, 2012a).

As the global demand for meat increases along with the commercialization of livestock feeding, 

international trade in livestock feed and protein meal supplements also increases, particularly in 

those countries where climate and geography restrict local production of these feed materials 

(USDA-FAS, 2012; USDA-OCE, 2012a). Egypt, the EU, Japan, Mexico, Southeast Asia, and 

South Korea are net importers of corn (USDA-OCE, 2012b). Approximately 15 to 20% of U.S. 

corn production is exported, with the volume of exports projected to decrease in the next several 

years in the face of increased competition from lower-priced South American supplies (USDAOCE, 2012b). China is projected to become a net importer of corn to support its expanding 

livestock and industrial sectors (James, 2009; USDA-OCE, 2011; USDA-OCE, 2012a; USDAOCE, 2012b). The increase in China’s imports are expected to account for one-third of the 

growth in world corn trade (USDA-OCE, 2012b). In addition to corn as grain, corn gluten feed is 

47
DRAFT PIONEER 4114 MAIZE

a major product in international trade in feed ingredients. Large volumes of U.S. corn gluten feed 

are exported to the EU (CRA, 2006).

Identity protection is important in international trade. Some countries are sensitive to the 

importation of GE crops, and some have yet to approve importation of GE corn varieties (see, 

e.g., ICTSD, 2005). For certain key export markets, such as Canada, Japan, Mexico, Taiwan, 

South Korea and China, developers will prepare regulatory submissions prior to the commercial 

launch of the product (Pioneer, 2011b). Specific end uses also may require identity protection 

throughout the export supply chain. For example, value enhanced specialty high-oil corn is an 

important part of the U.S. export market as a replacement for animal fats in feed rations (USDAFAS, 2004). Identity protection (as discussed in Subsection 2.2.3 – Organic Corn Farming and 

Specialty Corn Systems) in international commodity movement increases the costs, as well as the 

premiums paid (USDA-FAS, 2004).

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DRAFT PIONEER 4114 MAIZE

3 ALTERNATIVES

This document analyzes the potential environmental consequences resulting from a

determination of nonregulated status of Pioneer 4114 Maize. To respond favorably to a petition 

for nonregulated status, USDA-APHIS must determine that Pioneer 4114 Maize is unlikely to 

pose a plant pest risk. Based on its PPRA (USDA-APHIS, 2012e), USDA-APHIS has concluded 

that Pioneer 4114 Maize is unlikely to pose a plant pest risk. Therefore, USDA-APHIS must 

determine that Pioneer 4114 Maize is no longer subject to 7 CFR Part 340 or the plant pest 

provisions of the Plant Protection Act of 2000. 

Two alternatives will be evaluated in this EA: 1) no action; and 2) determination of nonregulated 

status of Pioneer 4114 Maize. USDA-APHIS has assessed the potential for environmental 

impacts for each alternative in Section 4 of this EA, Environmental Consequences. 

Pioneer has indicated its intention to limit the cultivation of Pioneer 4114 Maize to use as a 

foundation stock for developing stacked hybrids through conventional breeding techniques 

(Pioneer, 2011b). In this process, the herbicide or insect resistance or other trait(s) in Pioneer 

4114 Maize would be combined with the traits from other corn crop varieties that are no longer 

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

Protection Act of 2000. USDA-APHIS does not have jurisdiction under the Plant Protection Act 

of 2000 and Part 340 to review such stacked hybrids developed using nonregulated articles and 

conventional hybridization techniques where there is no evidence of a plant pest risk.

Accordingly, this EA focuses on the cultivation of Pioneer 4114 Maize. Issues associated with 

potential future stacking are presented and discussed in the cumulative impacts analyses (see 

Section 5 – Cumulative Impacts), where appropriate.

3.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE

Under the No Action Alternative, USDA-APHIS would deny the petition. Pioneer 4114 Maize

and progeny derived from Pioneer 4114 Maize would continue to be regulated articles under the 

regulations at 7 CFR Part 340. Permits issued or notifications acknowledged by USDA-APHIS

would still be required for introductions of Pioneer 4114 Maize and measures to ensure physical 

and reproductive confinement would continue to be implemented. USDA-APHIS might choose 

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

the unconfined cultivation of Pioneer 4114 Maize. 

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

PPRA that Pioneer 4114 Maize is unlikely to pose a plant pest risk (USDA-APHIS, 2012e).

Choosing this alternative would not satisfy the purpose and need of making a determination of 

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

3.2 PREFERRED ALTERNATIVE: DETERMINATION THAT PIONEER 4114 MAIZE 

IS NO LONGER A REGULATED ARTICLE

Under this alternative, Pioneer 4114 Maize and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR Part 340. Pioneer 4114 Maize is unlikely to 

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

49
DRAFT PIONEER 4114 MAIZE

USDA-APHIS would no longer be required for introductions of Pioneer 4114 Maize and 

progeny derived from this event. 

This alternative best meets the purpose and need to respond appropriately to a petition for 

nonregulated status based on the requirements in 7 CFR Part 340 and the agency’s authority 

under the plant pest provisions of the Plant Protection Act of 2000. Because the agency has 

concluded that Pioneer 4114 Maize is unlikely to pose a plant pest risk, a determination of 

nonregulated status of Pioneer 4114 Maize is a response that is consistent with the plant pest 

provisions of the Plant Protection Act of 2000, the regulations codified in 7 CFR Part 340, and 

the biotechnology regulatory policies in the Coordinated Framework.

Under this alternative, growers may have future access to Pioneer 4114 Maize and progeny 

derived from this event if the developer decides to commercialize Pioneer 4114 Maize for use in 

breeding programs. In addition, growers and other parties that are involved in production, 

handling, processing, or consumption of corn would continue to be able to use the current corn

products developed by conventional breeding as well as the GE corn variety. By granting 

nonregulated status to Pioneer 4114 Maize, the purpose and need to allow the safe development 

and use of GE organisms is met. 

3.3 ALTERNATIVES CONSIDERED BUT REJECTED FROM FURTHER 

CONSIDERATION 

USDA-APHIS assembled a comprehensive list of alternatives that might be considered for 

Pioneer 4114 Maize. USDA-APHIS evaluated these alternatives in light of the agency's authority 

under the plant pest provisions of the Plant Protection Act of 2000, 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 Pioneer 4114 Maize. Based on this evaluation,

USDA-APHIS rejected several alternatives. These alternatives are discussed briefly below along 

with the specific reasons for rejecting each.

3.3.1 Prohibit Any Pioneer 4114 Maize from Being Released

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

marketplace, USDA-APHIS considered prohibiting the release of Pioneer 4114 Maize, including 

denying any permits associated with the field testing. USDA-APHIS determined that this 

alternative is not appropriate given that Pioneer 4114 Maize is unlikely to pose a plant pest 

risk (USDA-APHIS, 2012e).

In enacting the Plant Protection Act of 2000, Congress found that—

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

regulated under [the Plant Protection Act] shall be based on sound 

science...§402(4) (codified at 7 U.S.C. §7701(4)).

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

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with EO 13563, to guide the development and implementation of 

policies for oversight of emerging technologies (such as GE) at the agency level. In accordance 

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DRAFT PIONEER 4114 MAIZE

with this memorandum, agencies should adhere to EO 13563 and, consistent with that EO, the 

following principle, among others, to the extent permitted by law, when regulating emerging 

technologies:

[D]ecisions should be based on the best reasonably obtainable scientific, 

technical, economic, and other information, within the boundaries of the 

authorities and mandates of each agency.

Based on its PPRA (USDA-APHIS, 2012e) and the scientific data evaluated therein, USDAAPHIS concluded that Pioneer 4114 Maize is not likely to present a plant pest risk.

Accordingly, there is no basis in science for prohibiting the release of Pioneer 4114 Maize.

3.3.2 Approve the Petition In Part

The regulations at 7 CFR 340.6(d)(3)(i) state that USDA-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

USDA-APHIS has concluded that Pioneer 4114 Maize is unlikely to pose a plant pest risk, there 

is no regulatory basis under the plant pest provisions of the Plant Protection Act of 2000 for 

considering approval of the petition only in part.

3.3.3 Isolation Distance between Pioneer 4114 Maize and Non-GE Corn and 

Geographical Restrictions

In response to public concerns of gene movement between GE and non-GE plants, USDAAPHIS considered requiring an isolation distance separating Pioneer 4114 Maize from 

conventional or specialty corn production. However, because USDA-APHIS has concluded that 

Pioneer 4114 Maize is unlikely to pose a plant pest risk (USDA-APHIS, 2012e), an alternative 

based on requiring isolation distances would be inconsistent with the statutory authority under 

the plant pest provisions of the Plant Protection Act of 2000 and regulations in Part 340.

USDA-APHIS also considered geographically restricting the production of Pioneer 4114 Maize

based on the location of production of non-GE corn in organic production systems in response to 

public concerns regarding possible gene movement between GE and non-GE plants. However, as 

presented in USDA-APHIS’ PPRA for Pioneer 4114 Maize, there are no geographic differences 

associated with any identifiable plant pest risks for Pioneer 4114 Maize (USDA-APHIS, 2012e). 

Moreover, in 2010, commercial products containing the 1507 x 59122 Maize were grown on 

approximately 14 million acres, or approximately 16% of the U.S. maize acres (GfK Kynetec, 

2010; Pioneer, 2011b). Hybrid varieties based on this cross present the same herbicide tolerance 

and insect resistance traits as Pioneer 4114 Maize. USDA-APHIS has no regulatory authority 

over the cultivation of the varieties based on this hybrid. Accordingly, this alternative was 

rejected and not analyzed in detail. USDA-APHIS has concluded that Pioneer 4114 Maize does 

not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographically 

restricted area (USDA-APHIS, 2012e). Therefore, such an alternative would not be consistent 

with USDA-APHIS’ statutory authority under the plant pest provisions of the Plant Protection 

Act of 2000 and regulations in Part 340 and the biotechnology regulatory policies embodied in 

the Coordinated Framework.

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DRAFT PIONEER 4114 MAIZE

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

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

status based on the requirements in Part 340 and the agency‘s authority under the plant pest 

provisions of the Plant Protection Act of 2000. Nevertheless, USDA-APHIS is not expecting 

substantial effects. However, individuals might choose on their own to geographically isolate 

their non-GE corn productions systems from corn incorporating the Pioneer 4114 Maize event or 

to use isolation distances and other management practices to minimize gene movement between 

cornfields. Information to assist growers in making informed management decisions for hybrid 

stacks based on Pioneer 4114 Maize is available from Association of Official Seed Certifying 

Agencies (AOSCA, 2004).

3.3.4 Requirement of Testing for Pioneer 4114 Maize

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

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

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

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

would be extremely difficult to implement and maintain. Additionally, because Pioneer 4114 

Maize does not pose a plant pest risk (USDA-APHIS, 2012e), the imposition of any type of 

testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act of 

2000, the regulations at Part 340, and the biotechnology regulatory policies embodied in the 

Coordinated Framework. Therefore, imposing such a requirement for Pioneer 4114 Maize would 

not meet USDA-APHIS’ purpose and need to respond appropriately to the petition in accordance 

with its regulatory authorities.

3.4 COMPARISON OF ALTERNATIVES

Table 3-1 presents a summary of the potential impacts associated with selection of either of the 

alternatives evaluated in this EA. The impact assessment is presented in Section 5 of this EA.

Table 3-1. Summary of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action Alternative B: Determination of 

Nonregulated Status

Meets Purpose 

and Need and 

Objectives

No Yes

Unlikely to pose a 

plant pest risk

Satisfied through use of regulated field trials Satisfied—risk assessment (USDA-APHIS, 

2012(USDA-APHIS, 2012d))

Management 

Practices

Acreage and Areas 

of Corn Production

88% of corn grown in U.S. is GE. 49% had 

stacked herbicide resistance and insect 

resistance. Corn yields are likely to increase. 

Unchanged from No Action Alternative

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DRAFT PIONEER 4114 MAIZE

Agronomic 

Practices

Crop rotation can be effective in controlling 

some insect pests such as rootworm. Reduced 

or conservation tillage has largely replaced 

conventional tillage.

Unchanged from No Action Alternative

Pesticide Use Insecticide use has declined since the 

introduction of insect-resistant corn varieties.

Insecticide use will decrease.

Corn Seed 

Production

Unchanged Unchanged

Organic Corn 

Production

Certified organic corn acreage is a small 

but increasing percentage of overall corn 

production. 

Unchanged from No Action Alternative.

Environment

Land Use Current trends in the acreage and areas of 

production are likely to continue to be 

driven by market conditions (i.e., 

increased demand for US corn and corn 

products for animal feed, ethanol, etc.) 

and federal policy 

Unchanged

Water Resources The primary cause of agricultural NPS 

pollution is increased sedimentation from 

soil erosion, which can introduce 

sediments, fertilizers, and pesticides to 

nearby lakes and streams. Agronomic 

practices such as conservation tillage, 

crop nutrient management, pest 

management, and conservation buffers 

help protect water quality from 

agricultural runoff 

Unchanged from No Action Alternative

Soil Agronomic practices such as crop type, 

tillage, and pest management can affect 

soil quality. Growers will adopt 

management practices to address their 

specific needs in producing corn 

Unchanged from No Action Alternative

Air Quality Agricultural activities such as burning, 

tilling, harvesting, spraying pesticides, 

and fertilizing, including the emissions 

from farm equipment, can directly affect 

air quality. Aerial application of 

insecticides may impact air quality from 

drift, diffusion, and volatilization of the 

Unchanged from No Action Alternative

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DRAFT PIONEER 4114 MAIZE

chemicals, as well as motor vehicle 

emissions from airplanes or helicopters. 

Climate Change Agriculture-related activities are 

recognized as both direct sources of 

greenhouse gases (GHGs) (e.g., exhaust 

from motorized equipment) and indirect 

sources (e.g., agriculture-related soil 

disturbance, fertilizer production) 

Unchanged from No Action Alternative

Animals and 

Plants

Animals Currently available insect-resistant do not 

impact populations of vertebrate animals 

or most invertebrate animals. Some 

varieties target lepidopteran (European 

corn borer and other species) or 

coleopteran (corn rootworm) pests. Nontarget invertebrates are generally more 

abundant in Bt cotton and Bt corn fields 

than in non-transgenic fields managed 

with chemical insecticides. Currently 

available glufosinate-resistant varieties do 

not impact nontarget organisms.

4114 Corn is not expected to have any 

effect on vertebrate animals or most 

invertebrate animals. 4114 Corn is toxic 

only to certain coleopteran and 

lepidopteran insects. Effects on these 

organisms is unchanged from the No 

Action Alternative 

Plants Corn fields can be bordered by other 

agricultural fields (including other corn 

varieties), woodlands, or pasture and 

grasslands. The most agronomically 

important members of a surrounding 

plant community are those that behave as 

weeds. Corn growers use production 

practices to manage weeds in and around 

fields 

Unchanged from No Action Alternative

Gene Movement Cultivated corn varieties can cross 

pollinate. Growers use various production 

practices to limit undesired cross 

pollination. 

Unchanged from No Action Alternative

Soil 

Microorganisms

Soil bacterial communities are influenced 

by plant species and cultivars as well as 

other environmental factors, such as soil 

type and agricultural practices. Bt plants 

may change the soil microbial community 

when compared to plants that do not 

express Bt. No deleterious effects have 

Unchanged from No Action Alternative

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DRAFT PIONEER 4114 MAIZE

been identified. No effects observed when 

glufosinate-resistant plants are cultivated.

Biological 

Diversity

There is no evidence of landscape-level 

effects from currently available Bt and/or 

glufosinate-resistant crops. Currently 

available Bt crops may increase nontarget abundance compared to broadspectrum insecticide use.

Unchanged from No Action Alternative.

Human and 

Animal Health

Risk to Human 

Health

Cry proteins of Bt corn products and the 

PAT protein are not toxic to humans and 

do not have any known allergenic 

properties for humans. 4114 Corn does 

not have any adverse human health 

effects. Limited field releases would not 

result in adverse health effects. 

Agricultural workers and pesticide 

applicators would be exposed to a variety 

of US-EPA -registered pesticides. The 

EPA’s Worker Protection Standard 

(WPS) (US-EPA, 1992); 40 CFR Part 

170.1, Scope and Purpose) requires 

employers to take actions to reduce the 

risk of pesticide poisonings and injuries 

among agricultural workers and pesticide 

handlers. The WPS contains requirements 

for pesticide safety training, notification 

of pesticide applications, use of personal 

protective equipment, restricted entry 

intervals following pesticide application, 

decontamination supplies, and emergency 

medical assistance. 

Unchanged from No Action Alternative 

A comprehensive assessment of the 

safety of 4114 corn demonstrated that 

the proteins in 4114 are nontoxic to 

mammals and unlikely to be a food 

allergen. US-EPA-registered pesticides 

that are currently used for corn 

production would continue to be used by 

growers under the Preferred Alternative. 

Agricultural production with 4114 corn 

does not require any change to the 

agronomic practices or chemicals 

currently used (i.e., pesticides) for 

conventional corn. Therefore, worker 

safety issues associated with the 

agricultural production of 4114 corn 

would remain the same as those under 

the No Action Alternative. 

Risk to Animal 

Feed

Cry proteins and the PAT protein are not 

expected to be allergenic, toxic, or 

pathogenic in mammals or poultry. Cry 

proteins also have a history of safe 

consumption in the context of other food 

and feeds.

A compositional analysis concluded that 

forage and grain from 4114 corn hybrids 

are considered similar in composition to 

forage and grain from both the nontransgenic comparator and conventional 

corn hybrids. Therefore this is 

unchanged from the No Action 

Alternative.

Socioeconomic

Domestic and 

Economic 

Farm income is positively impacted by 

currently available Bt and herbicideresistant corn by reducing production 

Under the preferred alternative, growers 

would have an additional tool to use 

against corn insect pests may reduce 

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DRAFT PIONEER 4114 MAIZE

Environment costs or increasing revenues. Pestresistant corn generally has a positive 

impact on farm income due to cost 

savings from reduced pesticide use.

economic loss, as well as another tool 

for herbicide management.

Trade Economic 

Environment

The primary US corn export destinations 

are also the largest world importers of 

corn and do not have major barriers for 

importing food or feed commodities 

produced from transgenic crops, 

including those with insect resistance 

traits. Nevertheless, import of each 

specific trait requires separate application 

and approval by the importing country.

To avoid adversely affecting 

international trade in corn 

commodities exported from the US 

(and Canada), the developer is taking 

steps to fulfill regulatory requirements 

for several countries expected to 

import the product.

Other Regulatory 

Approvals

FDA completed consultations, EPA tolerance 

exemptions and conditional pesticide 

registrations granted

FDA completed consultations, EPA 

tolerance exemptions and conditional 

pesticide registrations granted

Compliance with 

Other Laws

CWA, CAA, EOs Fully compliant Fully compliant

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DRAFT PIONEER 4114 MAIZE

4 ENVIRONMENTAL CONSEQUENCES

4.1 SCOPE OF THE ENVIRONMENTAL ANALYSIS

This analysis of potential environmental consequences addresses the potential impact to the 

human environment from the alternatives analyzed in this EA, namely taking No Action (i.e., 

leaving current restrictions in place) and the Preferred Alternative (i.e., unconfined cultivation of 

Pioneer 4114 Maize). Potential environmental impacts from the No Action Alternative and the 

Preferred Alternative for Pioneer 4114 Maize are described in detail throughout this section. A 

cumulative impacts analysis for each environmental issue is presented in Section 5 – Cumulative 

Impacts. Certain aspects of this product and its cultivation would be no different between the 

alternatives; those instances are described below. 

For the analysis of Environmental Consequences in this draft EA, we note that Pioneer 4114 

Maize contains traits from two GE maize varieties that are no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000.

The Cry1F protein and its associated genetic elements in Pioneer 4114 Maize are identical to 

those in DAS‐01507‐1 Maize (hereafter referred to as 1507 Maize), which had a determination 

of nonregulated status by USDA, was registered by the EPA, and was reviewed by the US-FDA 

in 2001 (US-FDA, 2001; USDA-APHIS, 2001; US-EPA, 2010f; Pioneer, 2011b). The binary 

Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements are identical to 

those in DAS‐59122‐7 Maize (hereafter referred to as 59122 Maize), which was reviewed by 

US-FDA in 2004, had a determination of nonregulated status by USDA in 2005, and was 

registered by US-EPA in 2005 (US-FDA, 2004; USDA-APHIS, 2005; US-EPA, 2010f; Pioneer, 

2011b). Both 1507 and 59122 Maize contain the PAT protein, which itself has had nonregulated 

status since 1995 and has been commercially available in the United States since 1996 (USDAAPHIS, 1995). The regulatory history of 1507 and 59122 Maize bears repeating here because 

commercial corn representing hybrids based on these varieties, including a conventional hybrid 

breeding stack of the two lines, 1507 x 59122, are now licensed broadly across the seed industry 

(Pioneer, 2011b). The 1507 x 59122 breeding stack combination was reviewed and registered by

US-EPA in 2005 (US-EPA, 2010f). Similarly, and as noted in Subsection 2.1, in 2005, the EFSA 

approved the marketing of 1507 maize for import, feed and industrial processing and cultivation 

(EFSA, 2005), in 2007, approved 59122 for import, feed and industrial processing (EFSA, 

2007), and since 2009, has reviewed and approved at least four commercial hybrids based on the 

1507 x 59122 hybrid stacks for food and feed uses, import and processing, in each case 

concluding and that the hybrid products were unlikely to have any adverse effects on human or 

animal health or on the environment (see, EFSA, 2009b; EFSA, 2009a; EFSA, 2010; EFSA, 

2011). In 2010, commercial products containing 1507 x 59122 Maize were grown on 

approximately 14 million acres or approximately 16% of U.S. maize acres (GfK Kynetec, 2010; 

Pioneer, 2011b).

Accordingly, as the events contained in Pioneer 4114 Maize are already commercially cultivated, 

this draft EA presents a summary of the Cry proteins and the PAT proteins and the events in 

Pioneer 4114 Maize within the Affected Environment section and an analysis within the 

Environmental Consequences section. For the discussion of environmental consequences, the 

following principal areas of potential environmental concern are addressed:

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DRAFT PIONEER 4114 MAIZE

• Agricultural Production of Corn (Subsection 4.2);

• Physical Environment (Subsection 4.3);

• Biological Resources (Subsection 4.4);

• Public Health (Subsection 4.5); 

• Animal Feed (Subsection 4.6); and

• Socioeconomic (Subsection 4.7).

Although the Preferred Alternative would allow for the cultivation of Pioneer 4114 Maize to 

occur anywhere in the United States for breeding stock, USDA-APHIS is limiting the 

environmental analysis to those areas that currently support corn production, as identified by the 

USDA-NASS 2007 Census of Agriculture (USDA-NASS, 2009).

The potential environmental consequences of the No Action and Preferred Alternative are 

analyzed under the assumption that farmers who produce conventional corn, Pioneer 4114 

Maize, or corn using organic methods are using reasonable, commonly accepted best BMP 

specific to their agricultural corn production.

4.2 AGRICULTURAL PRODUCTION OF CORN

BMPs are commonly accepted, practical ways to grow corn. These management practices 

consider crop-specific planting dates, seeding rates, and harvest times, among others. Over the 

years, corn production has resulted in well-established management practices that are available 

through local Cooperative Extension Service offices and their respective websites. The National 

Information System for the Regional Integrated Pest Management (IPM) Centers publishes crop 

profiles for major crops on a state-by-state basis. These crop profiles provide production 

guidance for local growers, including recommended practices for specific pest control. Crop 

profiles for many of the corn production states can be reviewed 

at www.ipmcenters.org/cropprofiles/index.cfm25.

Pioneer’s studies demonstrate that agronomic characteristics and cultivation practices required 

for Pioneer 4114 Maize are essentially indistinguishable from practices used to grow other corn 

varieties, including other GE varieties, such as 1507, 59122, and 1507 x 59122 Maize (Pioneer, 

2011b; USDA-APHIS, 2012e). None of the BMPs currently employed for corn production is 

expected to change if Pioneer 4114 Maize is no longer subject to the regulatory requirements of 

7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000. Accordingly, the 

potential impacts on agricultural production of Pioneer 4114 Maize resulting from management 

practices associated with the No Action and Preferred Alternative are the same, as discussed 

below in Subsections 4.2.1 – Areas and Acreage of Corn Production; 4.2.2 – Agronomic

Practices; and 4.2.3 – Organic Corn Farming and Specialty Corn Production.

25 Last accessed October, 2012.

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DRAFT PIONEER 4114 MAIZE

4.2.1 Areas and Acreage of Corn Production

GE and non-GE corn varieties are continually under development. In 2012, corn was cultivated 

on over 96 million acres (USDA-NASS, 2012b). Approximately 88% of U.S. corn acreage is 

planted with GE corn (USDA-NASS, 2012b).

4.2.1.1 No Action: Areas and Acreage of Corn Production 

Under the No Action Alternative, existing trends related to area and acreage of corn is expected 

to continue. Corn is expected to continue being commercially cultivated in 48 U.S. States, with 

the majority of production centered in the Midwestern Corn Belt (USDA-NASS, 2012b).

As discussed in Subsection 4.1 – Scope of the Environmental Analysis, Pioneer 4114 Maize 

contains traits from GE corn varieties that are no longer subject to the regulatory requirements of 

7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000. These corn 

varieties are 1507, 59122, and 1507 x 59122 Maize (US-EPA, 2010f; Pioneer, 2011b). All three

corn products are now licensed broadly across the seed industry (Pioneer, 2011b), covering 

approximately 16% of U.S. maize acres (GfK Kynetec, 2010; Pioneer, 2011b). The current

cultivation of these existing corn varieties, especially 1507 x 59122 Maize, strongly suggests that 

traits contained in Pioneer 4114 Maize (e.g., Cry1F, Cry34Ab1, Cry35Ab1, and PAT) will 

maintain a continued presence in the U.S. corn market under the No Action Alternative.

With regard to acreage, conventional corn production will likely continue to gradually increase, 

based on current acreage trends (USDA-OCE, 2012a). Dictating this general increase in U.S. 

corn acreage are external market forces across many commercial sectors. Increasing demand and 

favorable net returns for corn products are likely to sustain the market for U.S. corn grain 

(USDA-OCE, 2012a). As discussed in Subsection 2.2 – Agricultural Production of Corn, this 

trend towards increased corn cultivation is not a result of cultivation of new farm land, but is

instead a consequence of the grower’s substitution of corn for other crops to take advantage of 

current crop pricing (USDA-ERS, 2011e). For example, the establishment of a bioethanol 

industry using corn as a feed stock is one of the key elements in the increase in acreage devoted 

to corn, with approximately 45% of the corn harvest dedicated to corn-based biofuel production

(USDA-ERS, 2012c). Since 2006, many U.S. cotton farmers have converted to corn and soybean 

because of favorable prices, and not because of access to a new corn variety (USDA-ERS, 2009; 

USDA-ERS, 2011e).

Additionally, government policies have and will continue enabling U.S. farmers to meet corn 

production targets by providing economic incentive to retain arable land in agricultural 

production. For example, two Federal policy tools were enacted to increase the amount of arable 

land for agricultural production while also encouraging farmer adoption of environmentallyfriendly practices to maintain agricultural productivity (USDA-ERS, 2011e). First, the Food, 

Conservation, and Energy Act (2008) required a net reduction in Conservation Reserve Program 

(CRP) land enrollment from 39.2 to 32 million acres. Second, the Act increased funding for 

Working Land Conservation Programs (e.g., The Environmental Quality Incentives Program 

[EQIP]).

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DRAFT PIONEER 4114 MAIZE

4.2.1.2 Preferred Alternative: Areas and Acreage of Corn Production 

The Preferred Alternative is not expected to extend the area of U.S. corn production or cause an 

increase in overall corn acreage, relative to the No Action Alternative. As discussed in 

Subsection 4.2.1.1 – No Action, Pioneer 4114 Maize already contains traits that are contained in 

currently-cultivated corn varieties. This is important to note, as Pioneer 4114 Maize is essentially 

phenotypically identical to 1507 x 59122 Maize. Accordingly, the potential impacts of the 

Preferred Alternative are likely to be similar to the No Action Alternative.

Pioneer’s studies and USDA-APHIS analyses demonstrate that agronomic characteristics and 

cultivation practices required for Pioneer 4114 Maize are essentially indistinguishable from other 

corn varieties, including 1507, 59122, and 1507 x 59122 Maize (Pioneer, 2011b; USDA-APHIS, 

2012e). Accordingly, Pioneer 4114 Maize might be expected to replace other varieties of corn 

currently cultivated, such as 1507 x 59122 Maize, that represent approximately 16% of the U.S. 

corn market (Pioneer, 2011b). Under the Preferred Alternative, there are no changes in 

agronomic characteristics in Pioneer 4114 Maize that would result in an a change in the area 

where corn is cultivated in the United States or an increase in acreage relative to the No Action 

Alternative (USDA-APHIS, 2012e). As noted in the No Action Alternative analysis in 

Subsection 4.2.1.1, the trend in increase in corn acreage is a function of market conditions 

driving growers to substitute corn for other crops. This trend is not specific to a single GE corn 

variety and is currently ongoing (USDA-ERS, 2011e). Consequently, this trend is not expected 

to be impacted by a determination of nonregulated status of Pioneer 4114 Maize. 

4.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs

As discussed in Subsection 2.2.2 – Agronomic Practices, corn cultivation requires substantial

management considerations regarding tillage, rotation, and agronomic inputs. Decisions 

concerning corn agronomic practices are dependent on grower want and need, and are ultimately 

reflective of external factors including geography, weed and disease pressure, economics of 

management of yield, and production system (rotation) flexibility (Heiniger, 2000; Farnham, 

2001; University of Arkansas, 2008). Choice of management practice often dictates 

marketability of a corn product, with certain agricultural consumer sectors stipulating 

requirements and restrictions regarding corn production methods.

4.2.2.1 No Action: Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs

No Action: Tillage and Crop Rotation

Under the No Action Alternative, trends related to tillage and crop rotation are likely to continue 

as currently practiced, as described in Subsection 2.2.2.1 – Tillage and Subsection 2.2.2.2 – Crop 

Rotation. 

Prior to planting corn, U.S. growers may use conventional, reduced, or conservation tillage to

prepare the soil for planting. Recent data from USDA-ERS and the USDA Agricultural Resource 

Management Survey (ARMS) indicate that conservation tillage has slightly increased in U.S. 

corn production at the expense of conventional tillage activities between 1998 and 2010 (Figure 

4-1). During this time period, no-till activities in U.S. corn production increased by 4% (4.3

60
DRAFT PIONEER 4114 MAIZE

million corn acres); however, this adoption of no-till practices was likely caused by shifts from 

growers already using conservation tillage and not conventional tillage practices (NRC, 2010). 

Figure 4-1. Adoption rates of three major tillage types in U.S. corn production, 1996 –

2010.

Source: USDA-ERS (2012a).

In contrast to other U.S. commodity crop production systems, trends of conservation tillage 

adoption in U.S. corn production are not directly attributable to the adoption of GE herbicideresistant corn varieties (NRC, 2010). This relatively weak relationship between conservation

tillage and herbicide-resistant corn adoption may be attributed to historical and current corn 

cultivation practices. Prior to the introduction of herbicide-resistant corn varieties, some U.S. 

corn growers were already using conservation tillage practices in their cultivation practices. A 

large portion of U.S. corn is grown in the Midwestern Corn Belt (USDA-NASS, 2012b). Due to

soil erosion concerns in this region, concerted conservation efforts were encouraged in this area, 

resulting in substantial increases in reduced-till and no-till corn acreage before herbicideresistant corn varieties were commercially available (Givens et al., 2009). Relative to cotton or 

soybean, adoption of conservation tillage in corn was higher prior to the development of 

herbicide-resistant varieties; consequently, the opportunity for adoption in corn was lower when 

herbicide-resistant varieties were first commercialized (Givens et al., 2009).

As discussed in Subsection 2.2.2.1 – Tillage, plant residues in conservation tillage has been 

identified as a potential challenge for corn disease and pest management. Recommended disease 

control measures are currently practiced and include cultivation of resistant hybrids, crop 

rotation, and more careful balancing of conservation tillage with residue management, with 

resistant hybrids the most economical method (Robertson et al., 2009).

Under the No Action Alternative, rotation strategies for corn are likely to continue as practiced 

today, with market demand and available technology strongly influencing corn rotation practices.

In 2010, 71% of corn acreage in 19 surveyed states was under some form of rotation (USDA0

10

20

30

40

50

60

1996 1997 1998 1999 2000 2001 2005 2010

Tillage strategy - % U.S. corn acreage

Year

Conservation Tillage Reduced Tillage Intensive (Conventional Tillage)

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DRAFT PIONEER 4114 MAIZE

NASS, 2011d). As noted in the No Action analysis in Subsection 4.2.1.1, the trend in increase in 

corn acreage is a function of market conditions driving growers to substitute corn for other crops, 

including the decision to adopt corn-to-corn production. This trend is not specific to a single GE

corn variety (USDA-ERS, 2011e) and is expected to continue as normally practiced under the 

No Action Alternative.

No Action: Agronomic Inputs

Under the No Action Alternative, current practices related to agronomic inputs in U.S. corn 

production are likely to continue as currently practiced. Grower application of inputs, as 

presented in Subsection 2.2.2.3 – Agronomic Inputs, is likely to continue as it is at present. 

As a consequence of farm-level decisions discussed in Subsection 2.2.2.3 – Agronomic Inputs, 

corn growers will continue to choose certain pesticides based on weed, insect and disease 

pressures, cost of seed and other inputs, technology fees, human safety, potential for crop injury, 

and ease and flexibility of the production system (Heiniger, 2000; Farnham, 2001; University of 

Arkansas, 2008). Practices related to fertilizer, insecticide, and herbicide application described in 

Subsection 2.2.2.3 – Agronomic Inputs is likely to continue as it is practiced today. Corn will 

continue to receive fertilizer inputs (Ritchie et al., 2008). The trends noted in Figure 2-1 and

presented in Subsection 2.2.2.3 – Agronomic Inputs are likely to continue. Herbicide use as a 

percent of total corn acres is expected to remain relatively consistent, insecticide use is 

anticipated to decline as more insect-resistant varieties are cultivated, and foliar fungicide 

applications may continue to increase (Pioneer, 2011b). Additionally, also noted in Subsection 

2.2.2.3 – Agronomic Inputs, the application of fungicides for seed treatment is expected to 

continue to increase as more fungicide treatments are brought to the market (see, e.g., Hoeft et 

al., 2000; Ruhl, 2007).

Insecticide use in U.S. corn production has steadily decreased as growers adopted the use of GE 

insect-resistant corn varieties (Brookes and Barfoot, 2010; Benbrook, 2012; Brookes et al., 

2012). Under the No Action Alternative, Pioneer 4114 Maize will remain a regulated article. 

However, as noted in Subsection 2.2.2.3 – Agronomic Inputs and Subsection 4.1 – Scope of the 

Environmental Analysis, U.S. corn growers already have access to the insect-resistant traits in 

Pioneer 4114 Maize. This includes access to the Cry1F protein in 1507 Maize to manage 

European corn borer and Cry34Ab1/Cry35Ab1 in 59122 Maize to manage corn root worm. This 

also includes access to a combination of the Cry1F and Cry34Ab1/Cry35Ab1 traits in 1507 x 

59122 Maize. Table 4-1 provides a complete summary of the US-EPA registrations for GE 

insect-resistant varieties containing Cry proteins found 1507 and 59122 Maize. In 2010, 

approximately 16% of the commercial U.S. corn acreage was planted with a 1507 x 59122 

hybrid (Pioneer, 2011b).

Similar to insecticide use in corn production, herbicide use has been profoundly affected by the 

adoption of GE herbicide-resistant corn varieties. As discussed in Subsection 2.2.2.3 –

Agronomic Inputs, the wide adoption of glyphosate-resistant corn varieties has resulted in 

glyphosate being applied to approximately 80% of U.S. corn acres (Pioneer, 2011b). In addition 

to glyphosate resistance, corn varieties have also been genetically engineered to exhibit 

resistance to glufosinate. Glufosinate use on corn in the United States has been relatively steady 

and low, accounting for between 2% and 6% of total U.S. corn acreage in the past decade 

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DRAFT PIONEER 4114 MAIZE

(Pioneer, 2011b). As discussed in Subsection 4.1 – Scope of the Environmental Analysis, GE 

corn varieties that are resistant to glufosinate include 1507, 59122, and 1507 x 59122 Maize. 

Other GE glufosinate-resistant corn varieties are listed in Table 4-1. Additionally, other 

glufosinate-resistant crops are used in U.S. agriculture; the use of glufosinate is not a new one. 

These varieties are listed in Table 4-2.

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DRAFT PIONEER 4114 MAIZE

Table 4-1. US-EPA registrations1 for commercial corn products containing 1507 and/or 59122 Maize.

Bt Event(s)

Product 

Name Company

EPA Reg. 

Number

Initial Date of 

Registration Expressed Trait Functions

1507 Herculex I 

Pioneer Hi-Bred 29964-3

May 18,2001 Lepidopteran resistance, resistance to 

glufosinate ammonium Mycogen Seeds (c/o Dow 

Agrosciences LLC) 68467-2

59122 Herculex 

Rootworm 

Pioneer Hi-Bred 29964-4

Aug. 31,2005 Coleopteran resistance, resistance to 

glufosinate ammonium Mycogen Seeds (c/o Dow 

Agrosciences LLC) 68467-5

1507 x 59122 Herculex 

XTRA 

Mycogen Seeds (c/o Dow 

Agrosciences LLC) 68467-6 

Oct. 27,2005 Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium Pioneer Hi-Bred 29964-5

MON890342 x 1507 x 

MON880173 x 59 122 

Genuity®

SmartStax®

Monsanto Company 524-581 

July 20, 2009

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium; added 

lepidopteran resistance from Cry1A.105 and 

Cry2Ab2 and coleopteran resistance from 

Cry3Bb1 

Mycogen Seeds (c/o Dow 

Agrosciences LLC) 68467-7

1507 x MON8104

Optimum 

Intrasect Pioneer Hi-Bred 29964-7 Feb. 24,2010

Lepidopteran resistance, resistance to 

glufosinate ammonium; added lepidopteran

resistance from Cry1Ab

1507 xMON810 x 

59122 

Optimum 

lntrasect 

Extreme 

Pioneer Hi-Bred 29964-8 Feb. 24,2010

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium; added 

lepidopteran resistance from Cry1Ab

90% 1507 x 59122 + 

10% 1507 

Optimum 

AcreMax 1 Pioneer Hi-Bred 29964-6 April 30, 2010 Lepidopteran and coleopteran resistance, resistance to glufosinate ammonium

90% 59122 + 10% 

non-Bt

Optimum 

AcreMaxRW Pioneer Hi-Bred 29964-10 April 30, 2010 Coleopteran resistance, resistance to glufosinate ammonium and refuge

Bt11 x MIR1625 x 

1507 

Agrisure 

Viptera 3220 Syngenta Seed Inc. 67979-15 March 29, 2011

Lepidopteran resistance, resistance to 

glufosinate ammonium; added lepidopteran 

resistance from Vip3Aa20

95% MON89034 x 

1507 x MON88017 x 

59122 + 5% non-Bt

Genuity®

SmartStax®

RIB Complete 

Monsanto Company 524-595 

April 8, 2011

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium and 

glyphosate; added lepidopteran resistance 

from Cry1A.105 and Cry2Ab2 and 

coleopteran resistance from Cry3Bb1 and a 

refuge.

Mycogen Seeds (c/o Dow 

Agrosciences LLC) 68467-16

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DRAFT PIONEER 4114 MAIZE

Table 4-1. US-EPA Registrations1 for Commercial Corn Products Containing 1507 and/or 59122 Maize. Continued.

Bt Event(s)

Product 

Name Company

EPA Reg. 

Number

Initial Date of 

Registration Expressed Trait Functions

Bt116 x 1507 x 

MIR6047 x 59122 

Agrisure 3 

122 Syngenta Seed Inc. 67979-17 June 10,2011

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium; added 

lepidopteran resistance from Cry1Ab and 

coleopteran resistance from Cry3A.

90% 1507 x MON810 

x 59122 + 10% nonBt

Optimum 

AcreMax Xtra Pioneer Hi-Bred 29964-11 Aug. 26, 2011

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium; added 

lepidopteran resistance from Cry1Ab and a 

10%refuge.

95% 1507 x MON810 

+ 5% non-Bt

Optimum 

AcreMax Pioneer Hi-Bred 29964-12 Aug. 26, 2011

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium; added 

lepidopteran resistance from Cry1Ab and a 

5% refuge

1507 x MIR604 Optimum 

Trisect Pioneer Hi-Bred 29964-13 Sept. 30, 2011

Lepidopteran resistance, resistance to 

glufosinate ammonium; added coleopteran 

resistance from Cry3A.

1507 x 59122 x 

MON810 x MIR604 + 

5% non-Bt

Optimum 

AcreMax 

Xtreme

Pioneer Hi-Bred 29964-16 March 7, 2012

Lepidopteran and coleopteran resistance, 

resistance to glufosinate ammonium; added 

lepidopteran resistance from Cry1Ab and 

coleopteran resistance from Cry3A and a 5% 

refuge.

Notes:

1. EPA registrations are focused on the Bt-based PIPs (the Cry proteins) presented in 1507 and 59122 Maize. US-EPA has no regulatory authority over the herbicide resistance expressed by the 

various maize varieties. To the extent that information was available, the herbicide resistance expressed by the respective maize products is provided.

2. MON89034 expresses the Cry1A.105 and Cry2Ab2 proteins, conferring resistance to certain lepidopterans.

3. MON88017 expresses the Cry3Bb1 protein, conferring resistance to certain coleopterans.

4. MON810 expresses the Cry1Ab protein, conferring resistance to certain lepidopterans.

5. MIR162 expresses the Vip3Aa20 protein, extracted from Bt, conferring resistance to certain lepidopterans.

6. Bt11 expresses the Cry1Ab protein, conferring resistance to certain lepidopterans.

7. MIR604 expresses the Cry3A protein, conferring resistance to certain coleopterans.

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DRAFT PIONEER 4114 MAIZE

Table 4-2. USDA-APHIS nonregulated products expressing the PAT protein conferring 

resistance to DL-Phosphinothricin, the ammonium salt of glufosinate, also known as 

glufosinate ammonium.

Year of 

Nonregulation

APHIS Product 

Identification 

Number Petitioner Crop Traits

1995 94-357-01p Agrevo Corn Phosphinothricin-resistant

1996 95-145-01p DeKalb Corn Phosphinothricin-resistant

1996 96-068-01p Agrevo Soybean Phosphinothricin-resistant

1998 97-205-01p Agrevo Rapeseed Phosphinothricin-resistant

1998 97-265-01p Agrevo Corn Phosphinothricin-resistant, 

Lepidopteran-resistant

1998 97-336-01p Agrevo Sugar beet Phosphinothricin-resistant

1998 97-342-01p Pioneer Corn Male sterile and Phosphinothricinresistant

1998 98-014-01p Agrevo Soybean Phosphinothricin-resistant (note 

relation to 96-068-01p petition)

1998 98-238-01p Agrevo Soybean Phosphinothricin-resistant

1999 98-278-01p Agrevo Rapeseed Phosphinothricin-resistant and 

pollination control

1999 98-329-01p Agrevo Rice Phosphinothricin-resistant

1999 98-349-01p Agrevo Corn Male sterile and Phosphinothricinresistant

2001 00-136-01p Mycogen c/o 

Dow and 

Pioneer

Corn Lepidopteran-resistant and 

Phosphinothricin-resistant (1507 

Maize)

2002 01-206-02p Aventis Rapeseed Phosphinothricin-resistant

2002 01-206-01p Aventis Rapeseed Phosphinothricin-resistant and 

pollination control

2003 02-042-01p Aventis Cotton Phosphinothricin-resistant

2004 03-181-01p Dow Corn Lepidopteran-resistant and 

Phosphinothricin-resistant

2005 03-353-01p Dow Corn Coleopteran-resistant and 

Phosphinothricin-resistant (59122 

Maize)

2006 06-234-01p Bayer Rice Phosphinothricin-resistant

2011 08-340-01p Bayer Cotton Phosphinothricin (glufosinate)-

resistant and Lepidopteran-resistant

Note: The information presented in this table was extracted from the USDA-APHIS BRS Table of Petitions for Nonregulated Status Granted or 

Pending as of November 12, 2012, found at http://www.aphis.usda.gov/biotechnology/not_reg.html

Under the No Action Alternative, growers will likely continue to experience the continued 

emergence of Bt-resistant insect pests and glyphosate-resistant weeds. These trends require

modifications of crop management practices to address these challenges, including the use of 

alternative herbicides for weed control (Norsworthy et al., 2012), alternative insect control

strategies (including alternative PIPs), mechanical cultivation practices, and strict adherence to 

crop refugia requirements (Benbrook, 2009; Gassmann et al., 2011).

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DRAFT PIONEER 4114 MAIZE

4.2.2.2 Preferred Alternative: Agronomic Practices: Tillage, Crop Rotation, and Agronomic 

Inputs 

Preferred Alternative: Tillage and Crop Rotation

Under the Preferred Alternative, current trends and practices related to tillage and crop rotation 

in U.S. corn production are unlikely to be substantially different than that which is occurring 

under the No Action Alternative in Subsection 4.2.2.1 – Agronomic Practices.

As discussed in Subsection 4.2.2.1 – No Action: Agronomic Practices, the adoption of GE 

herbicide-resistant corn varieties did not strongly affect trends related to the adoption of 

conservation tillage practices in U.S. corn production. As an herbicide-resistant (i.e., glufosinateresistant) corn variety that is intended to replace cultivation on some acres of a very similar 

herbicide-resistant corn variety (e.g., 1507 x 59122 Maize), Pioneer 4114 Maize is unlikely to 

substantially affect tillage practices in corn. Consequently, patterns of tillage are unlikely to be 

substantially different under the Preferred Alternative compared to the No Action Alternative.

Pioneer 4114 Maize is essentially indistinguishable from other currently cultivated corn varieties

in terms of agronomic characteristics and cultivation practices (Pioneer, 2011b; USDA-APHIS, 

2012e). This includes 1507 x 59122 Maize, a currently-available corn variety that is 

phenotypically identical to Pioneer 4114 Maize. This strongly suggests that Pioneer 4114 Maize 

would likely benefit from the crop rotation strategies discussed in Subsection 2.2.2.2 – Crop 

Rotation. However, as discussed in Subsection 4.2.2.1 – No Action: Agronomic Practices, 

growers may currently adopt crop rotation strategies based upon market and field conditions. A 

determination of nonregulated status of Pioneer 4114 Maize is unlikely to change these market 

conditions, as market demand for corn is dependent on product end use and not any one GE corn 

variety. Accordingly, crop rotation in corn is unlikely to be substantially different under the 

Preferred Alternative compared to the No Action Alterative.

Preferred Alternative: Agronomic Inputs

Under the Preferred Alternative, agronomic inputs associated with U.S. corn production is likely 

to continue as described in the analysis of the No Action Alternative in Subsection 4.2.2.1 –

Agronomic Practices.

Pioneer 4114 Maize is essentially indistinguishable from other currently cultivated corn varieties

in terms of agronomic characteristics, cultivation practices, and disease susceptibility (Pioneer, 

2011b; USDA-APHIS, 2012e). This suggests that Pioneer 4114 Maize would require similar 

levels of fertilization as conventional corn varieties and benefit from the use of fungicides. Under 

the Preferred Alternative, Pioneer 4114 Maize is unlikely to substantially affect trends related to 

fertilization and fungicide use compared to the No Action Alternative. 

Under the Preferred Alternative, Pioneer 4114 Maize will provide growers access to insectresistant and herbicide-resistant traits that are already available to U.S. corn growers. As noted in 

Subsection 2.2.2.3 – Agronomic Inputs and Subsection 4.1 – Scope of the Environmental 

Analysis, this includes the Cry1F protein in 1507 Maize to manage European corn borer and 

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DRAFT PIONEER 4114 MAIZE

Cry34Ab1/Cry35Ab1 in 59122 Maize to manage corn root worm. This also includes access to a 

combination of the Cry1F and Cry34Ab1/Cry35Ab1 traits in 1507 x 59122 Maize. Additionally, 

U.S. corn growers will continue having access to glufosinate-resistant corn varieties. 

Glufosinate-resistant corn varieties also include 1507, 59122, and 1507 x 59122 Maize.

A determination of nonregulated status of Pioneer 4114 Maize would provide growers with 

continued access to corn breeding stock product expressing multiple Cry proteins offering 

resistance to lepidopteran and coleopteran pests. In 2010, commercial corn products containing 

1507 x 59122 Maize were grown on approximately 14 million acres, or approximately 16% of 

the U.S. corn acres (GfK Kynetec, 2010; Pioneer, 2011b). As Pioneer 4114 contains the same 

insect-resistant traits as 1507 x 59122 Maize, is virtually indistinguishable from 1507 x 59122 

Maize, and is intended to replace 1507 x 59122 Maize on some U.S. corn acres, trends related to 

insecticide use would likely continue as currently practiced under No Action Alternative. This 

includes, as described in Subsection 2.2.2.3 – Agronomic Inputs and Subsection 4.2.2.1 – No 

Action, a decrease in the volume of insecticides (Brookes and Barfoot, 2012; Brookes et al., 

2012).

A determination of nonregulated status is unlikely to substantially affect glufosinate use in U.S. 

corn production. As described in Subsection 2.2.2.3 – Agronomic Inputs and Subsection 4.2.2.1 

– No Action, glufosinate is already used on corn. There are no proposed label changes for 

glufosinate use associated with the cultivation of Pioneer 4114 Maize (Pioneer, 2011b), meaning 

that glufosinate use patterns will remain the same as currently-available glufosinate-resistant

corn varieties. Additionally, because Pioneer 4114 Maize is phenotypically identical to 1507 x 

59122 Maize, it can be reasonable expected that Pioneer 4114 Maize will replace some 1507 x 

59122 Maize acreage. USDA-APHIS assumes that all glufosinate use would be in accordance 

with the label application requirements established by the US-EPA. For these reasons, 

glufosinate use trends under the Preferred Alternative are not expected to be substantially 

different than glufosinate use trends under the No Action Alternative.

Trends related to the development of and the management of Bt-resistant insect pests and 

glyphosate-resistant weed populations are not anticipated to be substantially different for the 

Preferred and No Action Alternatives. Pioneer 4114 Maize is phenotypically identical to 1507 x 

59122 Maize, a GE corn variety already cultivated in the United States, and is thus intended to 

replace some 1507 x 59122 Maize acreage. Pioneer 4114 Maize will likely require similar refuge 

requirements and cultivation practices as 1507 x 59122 Maize. Accordingly, Bt-resistant insect 

pests and glyphosate-resistant weed populations may continue to develop, as described in 4.2.2.1 

– No Action. However, strategies to manage resistant insect and weed pests are likely to be as 

applicable to Pioneer 4114 Maize as the currently-cultivated 1507 x 59122 Maize. Thus, the 

trends related to the evolution of and the management of Bt-resistant insect pests and glyphosateresistant weed populations are not anticipated to be substantially different between the Preferred 

and No Action Alternatives.

A determination of nonregulated status of Pioneer 4114 Maize would continue providing

growers with another corn hybrid exhibiting resistance to glufosinate ammonium, offering 

another option for managing glyphosate-resistant weeds — a potentially valuable trait in those 

corn cultivation areas where herbicide-resistant weeds have emerged. This could allow for 

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DRAFT PIONEER 4114 MAIZE

improved corn grain yields when grown in the vicinity of glyphosate-resistant weeds. This 

practice of using herbicides with alternative modes of action is expected to potentially diminish 

the populations of glyphosate-resistant weeds (Dill et al., 2008; Duke and Powles, 2008; Owen, 

2008; Duke and Powles, 2009b). Applications of herbicides with mixed modes of action also are 

expected to prolong the development of new herbicide-resistant weed populations (Owen, 2008; 

Duke and Powles, 2009b). 

4.2.3 Organic Corn Farming and Specialty Corn Production

4.2.3.1 Organic Corn Farming

Organic production plans prepared pursuant to the NOP include practical methods to prevent comingling of organic and GE corn. The adventitious presence of GE corn with organic corn is a 

concern for some, knowing that corn naturally cross-pollinates (Coulter et al., 2010), though 

common agricultural practices are already used by corn growers to limit cross pollination.

Typically, organic growers use more than one method to prevent unwanted material from 

entering their fields including: isolation of the farm; physical barriers or buffer zones between 

organic production and non-organic production; planting border or barrier rows to intercept 

pollen; changing planting schedules to ensure flowering at different times; and maintaining 

formal communications between neighboring farms (NCAT, 2003; Baier, 2008; Roth, 2011).

These practices follow the same system used for the cultivation of certified seed under the 

AOSCA procedures. During the growing season, gene flow is managed by understanding corn 

pollen dispersal and maintaining adequate distances between fields (Thomison, 2009; MallorySmith and Sanchez-Olguin, 2011). A minimum isolation distance of 250 feet between varieties is 

recommended; whereas, 700 feet is preferred for complete isolation (Diver et al., 2008).

USDA-APHIS recognizes that producers of non-GE corn, particularly producers who sell their

products to markets sensitive to GE traits (e.g., organic or some export markets), reasonably can 

be assumed to be using practices on their farm to protect their crop from unwanted substances 

and thus maintain their price premium. USDA-APHIS will assume that growers of organic corn 

are already using, or have the ability to use, these common practices as USDA-APHIS’s baseline 

for the analysis of the alternatives.

No Action: Organic Farming 

In 2011, certified organic corn production was approximately 169,000 acres, representing a 

decrease from approximately 194,000 acres in 2008 (USDA-NASS, 2012a). This decrease 

occurred in the presence of GE and non-GE corn varieties. 

Organic corn production is occurring in the presence of conventional corn production using GE 

and non-GE corn varieties. As discussed in Subsection 4.1 – Scope of the Environmental 

Analysis, some of these currently-cultivated corn varieties include 1507, 59122, and 1507 x 

59122 Maize. Under the No Action Alternative, it is likely that organic corn farming will 

continue in the presence of these GE corn varieties.

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DRAFT PIONEER 4114 MAIZE

Organic producers employ a variety of measures to manage identity and preserve the integrity of 

organic production systems (NCAT, 2003). Historically, organic corn production represented a 

small percentage (approximately, 0.2%) of total U.S. corn acreage (USDA-ERS, 2011g). The

percentage of corn acreage dedicated to organic corn is not anticipated to change under the No 

Action Alternative. Current availability of seed for conventional (both GE and non-GE) corn 

varieties, and those corn varieties that are developed for organic production, is expected to 

remain the same under the No Action Alternative. Organic growers are already using accepted 

agricultural practices to reduce or limit cross pollination between corn varieties. The grower 

strategies employed to support this are not expected to change and likely will remain the same 

under the No Action Alternative. Planting and production of GE, non-GE, and organic corn will 

continue to fluctuate with market demands, as it has over the last 10 years, and these markets are 

likely to continue to fluctuate under the No Action Alternative (USDA-ERS, 2011f; USDA-ERS, 

2011h; USDA-ERS, 2012c).

Preferred Alternative: Organic Farming 

Organic corn production is unlikely to be affected by a determination of nonregulated status for 

Pioneer 4114 Maize. As discussed in Subsection 4.1 – Scope of the Environmental Analysis,

corn varieties containing the Cry and PAT proteins in Pioneer 4114 Maize are already cultivated

in the United States (e.g., 1507, 59122, and 1507 x 59122 Maize). In 2010, commercial corn 

products containing 1507 x 59122 Maize were grown on approximately 16% of U.S. maize acres

(GfK Kynetec, 2010; Pioneer, 2011b). Pioneer 4114 Maize may be expected to replace some 

1507 x 59122 Maize acreage, as the corn varieties are phenotypically identical. Additionally, 

agronomic trials conducted in a variety of locations in the United States demonstrated that 

Pioneer 4114 Maize is not substantially different in plant growth, yield, and reproductive 

capacity from conventional corn, including 1507 x 59122 Maize (USDA-APHIS, 2012e). No 

differences were observed in pollen diameter, weight, and viability. Therefore, Pioneer 4114 

Maize is expected to present a no greater risk of cross-pollination than that of existing corn 

cultivars, including 1507 x 59122 Maize. The practices currently employed to preserve and 

maintain purity of organic production systems would not be required to change to accommodate 

the production of Pioneer 4114 Maize.

Accordingly, the determination of nonregulated status of Pioneer 4114 Maize is not expected to 

have a substantial impact on organic corn production, as it likely that Pioneer 4114 Maize will 

simply replace some of 1507 x 59122 Maize that is already cultivated.

4.2.3.2 Specialty Corn Production

No Action: Specialty Systems

Specialty corn production is occurring in the presence of convention corn production using GE 

and non-GE corn varieties. As discussed in Subsection 4.1 – Scope of the Environmental 

Analysis, some of these currently-cultivated corn varieties include 1507, 59122, and 1507 x 

59122 Maize. Under the No Action Alternative, it is likely that specialty corn production will 

continue in the presence of these GE corn varieties.

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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 (Bradford, 2006). These management practices 

include maintaining isolation distances to prevent pollen movement from other corn sources, 

planting border or barrier rows to intercept pollen, changing planting schedules to ensure 

flowering at different times, and employing natural barriers to pollen (Wozniak, 2002; NCAT, 

2003; Bradford, 2006; Thomison, 2009; Roth, 2011). These management practices allow the 

grower to meet standards for the production of specialty crop seed, maintain genetic purity, and 

protect the genetic diversity of corn (Bradford, 2006).

Current availability of seed for specialty corn varieties is expected to remain the same under the 

No Action Alternative. The supply chain practices described in Subsection 2.2.3.2 – Specialty 

Corn which growers employ to preserve and maintain identity (e.g., isolation distances, planting 

of border and barrier rows, field monitoring, and seed handling standards and practices from

planting, harvesting transporting, storage and cleaning are not expected to change (see, e.g., 

Wozniak, 2002; AOSCA, 2004; Bradford, 2006). 

Preferred Alternative: Specialty Systems 

As noted in the discussion of Seed Production and Organic Corn Production, no changes in the 

production or cultivation of specialty corn are required to accommodate Pioneer 4114 Maize, as 

Pioneer 4114 Maize is similar to conventional corn, including the already-cultivated 1507 x 

59122 Maize variety. According to the petition, agronomic trials conducted in a variety of 

locations in the United States demonstrated that Pioneer 4114 Maize is not substantially different 

in plant growth, yield, and reproductive capacity from its conventional corn (Pioneer, 2011b; 

USDA-APHIS, 2012e). No differences were observed in pollen diameter, weight, and viability.

Therefore, Pioneer 4114 Maize is expected to present a similar risk of cross-pollination as 

existing corn cultivars including other GE corn varieties. The practices currently employed to 

preserve and maintain purity of specialty corn production systems would not be required to 

change to accommodate the production of Pioneer 4114 Maize. A determination of nonregulated 

status of Pioneer 4114 Maize under the Preferred Alternative would not change the availability 

and genetic purity of seed for specialty corn varieties. Conventional management practices and 

procedures, as described previously for corn seed production, proper seed handling, protection of 

wild relatives of corn, and organic corn farming, are in place to protect and maintain the genetic 

diversity of corn. Corn growers have used these methods effectively to meet the standards for the 

production of specialty crop seed. Impacts would be similar to the No Action Alternative.

Specialty system farmers, or other farmers who choose to plant non-GE corn varieties or sell 

non-GE corn seed, are unlikely to be impacted by the expected cultivation of Pioneer 4114 

Maize. Transgenic corn lines including those that contain herbicide-resistant and insect-resistant 

traits are already in use by farmers. Pioneer 4114 Maize should not present any new and different 

issues and impacts for specialty corn producers and consumers.

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4.3 PHYSICAL ENVIRONMENT

4.3.1 Soil Quality

This subsection discusses the potential consequences of the No Action and the Preferred 

Alternative on soil quality. Conservation tillage historically has not been the major tillage system 

in corn production. In 1996, over 60% of the corn acreage was either conventional (30%) or 

reduced tillage (32%), with the balance split between mulch and no-till systems (Christensen, 

2002). As noted in Subsection 2.2.2.1 – Tillage, minimal tillage in corn was being adopted prior 

to the introduction of GE herbicide-resistant varieties (Givens et al., 2009). 

The soil environment in and around crop fields is complex and rich in microorganisms, including 

bacteria and fungi. Potential impacts on microorganisms are discussed in Subsection 4.4.3 – Soil 

Microorganisms.

4.3.1.1 No Action: Soil Quality

Under the No Action Alternative, soil quality will remain the same as the present. Current 

agronomic practices associated with corn production including tillage, cultivation, applications 

of pesticides and fertilizer, and the use of agricultural equipment are not expected to change 

under the No Action Alternative. As discussed in Subsections 2.2 - Agronomic Practices and

2.3.1 – Soil Quality, current cultivation practices reduce insecticide use, and substitute 

glufosinate for more toxic herbicides, providing potential indirect soil quality benefits (Towery 

and Werblow, 2010; Brookes et al., 2012). Risks are reduced associated with environmental 

spills or misapplications of chemical herbicides and insecticides to the soil, as well as reductions 

in the frequency with which these products may be applied. As corn resistant to glufosinate and 

containing the Cry proteins within Pioneer 4114 Maize are already on the market (e.g., 1507, 

59122, and 1507 x 59122 Maize), these indirect benefits to soil quality do not change under the 

No Action Alternative.

The development of glyphosate-resistant weeds or weed management tillage practices potentially 

impact soil quality. A variety of strategies should be utilized in addressing glyphosate-resistant

weeds, including applying the right strength of herbicide, rotating herbicide modes of action, 

crop rotation, spot treatments, vigilant scouting, and hand weeding (Gunsolus, 2002; Sellers et 

al., 2011). In the long term, more diverse weed management tactics, potentially including more 

aggressive tillage practices that can affect soil quality, may be needed to address the increasing 

emergence of glyphosate-resistant weeds (Beckie, 2006; Owen, 2011; Owen et al., 2011b). The 

particular mix of weed management tactics selected by an individual producer is dependent upon 

many factors, including the agroecological setting, the problem weed type, and agronomic and 

socioeconomic factors important to farmers (Beckie, 2006).

As noted above in Section 4.2.2 – Agronomic Practices, glufosinate is already used on the 

LibertyLink® corn varieties, such as 1507 x 59122 Maize. In 2010, glufosinate was applied on 

approximately 2% of U.S. corn acreage. Glufosinate ammonium is weakly adsorbed to and is 

highly mobile in soil, undergoes rapid microbial degradation in soil, and has a short soil residual 

half-life of between 12 and 70 days (CERA, 2002; Senseman, 2007; US-EPA, 2008b). 

Glufosinate has high leaching potential in soil; however, it degrades rapidly and, therefore, is 

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typically found no deeper than 15 centimeters (approximately 6 inches) in soil (Senseman, 

2007). Implementation of BMP 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 soil (USEPA, 2008b). Information on the direct impacts of glufosinate to soil microorganisms is 

presented in Subsection 4.4.3 – Soil Microorganisms. 

As noted in Subsection 4.1 – Scope of the Environmental Analysis, the PAT and Cry proteins are 

currently cultivated, resulting in widespread dispersal of these proteins in U.S. cornfields. The 

pat gene was originally isolated from S. viridochromogenes; the Bt genes encoding for the Cry 

proteins were originally isolated from Bt (Pioneer, 2011b). Both S. viridochromogenes and B.

thuringiensis are naturally occurring soil bacteria and are not pathogenic (US-EPA, 1998; 

Hérouet et al., 2005).

GE corn varieties containing Cry proteins, including 1507 x 59122 Maize, are already cultivated

in the United States. The Bt source for the Cry proteins is ubiquitous in soils (US-EPA, 1998). Bt 

toxins (e.g., Cry1F, Cry34Ab1, and Cry35Ab1) may persist in soils for several months (US-EPA, 

1998). However, proteins do not bio-accumulate; the biological nature of these Cry proteins 

makes them readily susceptible to metabolic, microbial, and abiotic degradation (US-EPA, 

2010b; US-EPA, 2010a). Field deposition of Cry proteins is associated with plant material (i.e., 

pollen, crop residue) or plant root exudates (e.g., carbohydrates and amino acids) (US-EPA, 

2010b; US-EPA, 2010a). This plant material typically stimulates microbial activity and 

reproduction. The US-EPA has determined that the Cry proteins are degraded rapidly by soil 

microflora upon elution from the soil (US-EPA, 2010b; US-EPA, 2010a). 

The US-EPA notes that many of the early experiments establishing Cry protein persistence in 

soil were based on bulk soil, rather than soils representing field conditions (US-EPA, 2010b; USEPA, 2010a). These bulk soil experiments did not represent the realistic field conditions, 

including degradation pathways in soil (US-EPA, 2010b; US-EPA, 2010a). The US-EPA expects 

that degradation rates under field conditions may be higher than bulk soil experiments would 

suggest (US-EPA, 2010b; US-EPA, 2010a). Additionally, although the US-EPA found that the 

Cry proteins showed little degradation in soils with low pH (pH 5), the US-EPA also noted that 

corn does not grow well below pH 5.6; therefore, under most production conditions, corn would 

not be grown on soils that would inhibit the rate of degradation (US-EPA, 2010b; US-EPA, 

2010a). The potential impacts of inadvertent exposure of non-target organisms to the residual 

Cry proteins in soil are discussed in Subsection 4.4.3 – Soil Microorganisms.

4.3.1.2 Preferred Alternative: Soil Quality

Under the Preferred Alternative, soil quality is not anticipated to be substantially different. As 

noted in Subsection 4.1 – Scope of the Environmental Analysis, Pioneer 4114 Maize contains 

identical genetic elements as 1507 and 59122 Maize varieties and represents a corn variety that is 

functionally equivalent to 1507 x 59122 Maize (Pioneer, 2011b). The crop management practices 

for Pioneer 4114 Maize will be the same as those employed for 1507, 59122, and 1507 x 59122 

Maize. No changes to agronomic practices typically applied in the cultivation of corn, including 

both commercially available GE corn as well as conventional varieties, are required for Pioneer 

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4114 Maize (Pioneer, 2011b). Pioneer’s field trial and laboratory analyses demonstrated that the 

agronomic performance of Pioneer 4114 Maize was phenotypically identical to its nontransgenic hybrids used as controls in the tests (Pioneer, 2011b; USDA-APHIS, 2012e).

Cultivation of Pioneer 4114 Maize did not require increases in applications of agronomic inputs

or changes in cultivation, planting, harvesting, and volunteer control (Pioneer, 2011b). The same 

practices employed for corn varieties under the No Action Alternative would be employed to 

cultivate Pioneer 4114 Maize varieties. 

Pioneer 4114 Maize offers growers another varietal option to apply glufosinate ammonium to 

control weeds in corn, though it is worth noting that Pioneer 4114 Maize may replace cultivation 

of the existing 1507 x 59122 Maize variety. As noted above in the No Action discussion, as well 

as Subsection 4.2.2 – Agronomic Practices, glufosinate is already used on corn varieties grown 

in the United States, and was applied on approximately 2% of the U.S. corn acreage in 2010.

Because glufosinate use is not expected to change in U.S. corn production, it is unlikely that soil 

quality will be substantially-affected by glufosinate use in Pioneer 4114 Maize.

Most corn acreage is currently planted to either glyphosate-resistant-only corn or herbicideresistant corn varieties stacked with other GE traits (Duke and Powles, 2009a; USDA-ERS, 

2011b). More diverse weed management tactics potentially including more aggressive tillage 

practices that can affect soil quality may be needed to address the increasing emergence of 

glyphosate-resistant weeds (Beckie, 2006; Owen, 2011; Owen et al., 2011b). Weed management 

practices needed for the production of 4114 corn would be no different than those used in other 

commercially available glufosinate-resistant corn cultivars.

Pioneer 4114 Maize is compositionally equivalent to conventional corn, including 1507, 59122, 

and 1507 x 59122 Maize (USDA-APHIS, 2012e). Consequently, any crop residue remaining in

the field to decompose is not anticipated to present any substantial indirect effects to soil quality

compared to the No Action Alternative.

The corn varieties on which Pioneer 4114 Maize is based, 1507, 59122, and 1507 x 59122

Maize, have been commercially available for many years (Pioneer, 2011b). There are no reports 

of impacts to soil resources associated with the commercial cultivation of these varieties. 

Consequently, cultivation of Pioneer 4114 Maize is not anticipated to negatively affect soil 

quality relative to the No Action Alternative following a determination of nonregulated status. 

4.3.2 Water Resources 

Corn is a water-sensitive crop with a low tolerance for drought, although the stress response and 

yield loss depends on the stage of the corn growth (Farahani and Smith, 2011). Corn requires 

approximately 4,000 gallons through the growing season to produce one bushel of grain (NCGA, 

2007a). The water demand is variable over the growing season. The greatest water demand 

occurs during the silk production stage in mid-season and is estimated at approximately two 

inches of water per week (or 0.3 inches per day) (Heiniger, 2000; Farahani and Smith, 2011).

As discussed in Subsections 2.3.1 and 4.3.1, conservation tillage practices, particularly no-till 

practices, are currently practiced on U.S. corn acres (Horowitz et al., 2010). Intensive monitoring 

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of surface water and groundwater proximate to agricultural fields has demonstrated that 

conservation tillage practices can reduce runoff from agricultural lands, decreasing NPS

pollution of suspended sediment, nutrients from fertilizers, and pesticides (University of 

Tennessee Agricultural Extension Service, 2010). Better nutrient management, including 

precision farming and variable rate applications, are ensuring inputs are used by the crop and are 

not entering ground or surface waters (US-EPA, 2005; USDA-NRCS, 2006b). 

The US-EPA considers water resources, and potential contamination of water resources, when 

registering a pesticide under FIFRA. Precautions to protect water resources, including aquatic 

animals and plants, if required, are provided on the pesticide label. 

4.3.2.1 No Action: Water Resources

Under the No Action Alternative, current land acreage and agronomic practices, including 

irrigation, tillage, and nutrient management associated with U.S. corn production would not be 

expected to change. Among the many GE corn varieties available, U.S. growers would continue 

to cultivate 1507, 59122 and 1507 x 59122 hybrid varieties and continue the agronomic practices 

and inputs associated with those varieties. These practices and inputs would include the use of 

glufosinate as an herbicide, as well as inclusion of the introduced Cry proteins as part of an 

insect pest management strategy. No expected changes to water use beyond current trends 

associated with corn production are expected for this alternative.

As discussed in Subsection 4.2.2 – Agronomic Practices, the herbicide glufosinate ammonium is 

already approved for use on corn (USDA-NASS, 2011a). As noted in Subsection 2.2 –

Agricultural Production of Corn, with the commercial introduction of GE herbicide-resistant

crops, persistent residual herbicides were replaced with shorter half-life herbicides that were 

more environmentally benign (Fernandez-Cornejo and Caswell, 2006; Shipitalo et al., 2008; 

Vencill et al., 2012). Currently capturing only approximately 2% of the corn market, glufosinate 

is considered one of these more benign products; because of glufosinate’s shorter half-life and 

lower sorption potential, glufosinate losses to surface water are lower than that reported for other 

herbicides (Battaglin et al., 2005; Shipitalo et al., 2008).

Glufosinate has not been found to be a source of impairment for any water body designated as 

impaired under §303(d) of the Clean Water Act (US-EPA, 2008b). Surface water may be 

impacted by glufosinate residues transported by runoff, but US-EPA label restrictions minimize 

potential impacts to water (US-EPA, 2008b). Glufosinate may leach to groundwater under 

certain conditions (such as soils with high permeability and shallow groundwater), but 

glufosinate degrades rapidly in soil from microbial activity and is rarely found deeper than 15 

centimeters (approximately 6 inches) from the soil surface (Senseman, 2007). Glufosinate is 

highly water soluble and stable in water; is considered to be essentially nonvolatile from soil and 

surface water, and adsorption to suspended solids and sediment has been observed to be low to 

high (US-EPA, 2000; HSDB, 2010). Biodegradation occurs in water bodies with a half-life 

greater than 64 days (US-EPA, 2000). The US-EPA has considered the potential impacts to 

water resources from the agricultural application of glufosinate ammonium, and has included 

label use restrictions and guidance for product handling intended to prevent impacts to water 

(see, e.g., Bayer, 2012). Label restrictions specific to water resources include, for example, 

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prohibiting applications directly to water (except as allowed for rice), managing proper disposal 

of equipment wash water, and adopting cultivation methods (e.g., no till) to limit runoff to 

surface water, and not applying the herbicide when rainfall is forecasted to occur within 48 hours

(Bayer, 2012). The implications of exposure to glufosinate are discussed in Subsection 4.4.1 –

Animal Communities.

As discussed in Subsection 4.1 – Scope of the Environmental Analysis, the Cry proteins in 

Pioneer 4114 Maize are already used in U.S. corn production, appearing for example, in 1507, 

59122, and 1507 x 59122 Maize. This means that the US-EPA has already considered potential 

impacts to surface water in its evaluation of Cry proteins as PIPs (see, e.g., US-EPA, 1998; USEPA, 2010b; US-EPA, 2010a). The major source of Cry proteins in freshwater is corn pollen 

(US-EPA, 2010b; US-EPA, 2010a). The EPA has determined that there are no risks to aquatic 

organisms from exposure to Cry proteins in corn pollen and other plant tissues in aquatic 

environments (US-EPA, 2010b; US-EPA, 2010a). Cry proteins are not considered a risk to 

drinking water or groundwater (US-EPA, 1998). The implications of inadvertent exposure to 

non-target freshwater organisms are discussed in Subsection 4.4.1 – Animal Communities. 

4.3.2.2 Preferred Alternative: Water Resources 

Under the Preferred Alternative, no substantial impact to water resources is anticipated from a 

determination of nonregulated status of Pioneer 4114 Maize, as it is functionally equivalent to 

currently-cultivated corn varieties (e.g., 1507 x 59122 Maize). 

With regard to irrigation, no differences in morphological characteristics and agronomic 

requirements were found between Pioneer 4114 Maize and conventional corn, including 1507, 

59122, and 1507 x 59122 Maize (Pioneer, 2011b; USDA-APHIS, 2012e). This strongly suggests 

that Pioneer 4114 Maize does not require more moisture than conventional corn. Also, as 

previously discussed in Subsection 4.2.1 – Areas and Acreage of Corn Production, the use of 

Pioneer 4114 Maize would not increase the total acres and range of U.S. corn production areas.

Because Pioneer 4114 Maize is expected to be cultivated in lieu of some corn varieties already in 

wide-commercial use (e.g., 1507 x 59122), the consequences of the Preferred Action Alternative 

on water use in corn production are the same as the No Action Alternative. Therefore, a 

determination of nonregulated status of Pioneer 4114 Maize is unlikely to change the current use 

of irrigation practices in commercial corn production compared to the No Action Alternative.

As discussed in Subsection 4.2.2 – Agronomic Practices, the herbicide glufosinate ammonium is 

already approved for use on corn, and the proposed application rates and total maximum annual 

application for use on Pioneer 4114 Maize are consistent with the current rates (Pioneer, 2011b; 

Pioneer, 2012). Because Pioneer 4114 Maize is expected to be cultivated in lieu of some corn 

varieties already in wide-commercial use (e.g., 1507 x 59122), and use of glufosinate on Pioneer 

4114 Maize is the same as these potentially replaced corn varieties, no substantial impacts to 

water resources from glufosinate use are anticipated under the Preferred Alternative compared to 

the No Action Alternative.

The corn varieties on which Pioneer 4114 Maize is based, 1507, 59122, 1507 x 59122 Maize, 

have been commercially available for many years. The genetic elements in Pioneer 4114 are 

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identical to the 1507 and 59122 Maize varieties. Consequently, it is unlikely that substantial 

impacts to water resources will occur as a result of Cry1F, Cry34Ab1, Cry35Ab1, and PAT 

proteins, as there are no reports of impacts to water resources associated with the commercial 

cultivation of these varieties. Additionally, US-EPA has already considered potential impacts to 

surface water in its evaluation of Cry proteins as PIPs, as described in the No Action Alternative 

(see, e.g., US-EPA, 1998; US-EPA, 2010b; US-EPA, 2010a). Cry proteins are not considered a 

risk to drinking water or groundwater (US-EPA, 1998).

Based on these findings, the potential impacts to water resources are expected to be the same

under the Preferred Alternative as under the No Action Alternative.

4.3.3 Air Quality

As discussed in Subsection 2.3.3 – Air Quality, traditional agricultural practices have the 

potential to cause negative impacts to air quality. Agricultural emission sources include smoke 

from agricultural burning, tillage, heavy equipment emissions, pesticide drift from spraying, and

indirect emissions of carbon dioxide and nitrous oxide the degradation of organic materials in the 

soil and from the use of nitrogen fertilizer (USDA-NRCS, 2006a; Aneja et al., 2009). 

Current corn agronomic practices have the potential to reduce air emissions from several of these 

sources. Conservation practices, including conservation tillage practices, require fewer tractor 

passes across a field, thereby decreasing dust generation and tractor emissions. Surface residues 

and untilled organic matter physically serve to hold the soil in place, thereby decreasing airborne 

soils and pesticide drift in wind-eroded soils.

4.3.3.1 No Action: Air Quality 

Under the No Action Alternative, current impacts to air quality associated with land acreage and 

cultivation practices associated with corn production, including cultivation practices related to

GE corn varieties such as 1507, 59122, and 1507 x 59122 Maize, are not likely to be affected.

Adoption of GE corn varieties is expected to continue. To the extent that the adoption and 

cultivation of GE corn varieties allow the grower to implement soil conservation practices

presented in Subsection 4.3.1 – Soil Quality, air quality improvement associated with these 

practices would be expected to follow. This would include both direct air quality effects, e.g.,

emissions from farm equipment, airborne soil erosion and pesticide drift, as well as indirect air 

quality effects, e.g., decreased carbon dioxide emissions associated with the use of conservation 

tillage (Hoeft et al., 2000; USDA-NRCS, 2006a; Aneja et al., 2009; US-EPA, 2012b). Air 

quality will continue to be affected by current agronomic practices associated with conventional 

methods of corn production such as tillage, cultivation, pesticide and fertilizer applications, and 

the use of agricultural equipment.

4.3.3.2 Preferred Alternative: Air Quality

Under the Preferred Alternative, a determination of nonregulated status of Pioneer 4114 Maize is 

unlikely to substantially impact air quality compared to the No Action Alternative.

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Pioneer 4114 Maize is similar in agronomic performance and likely requires similar cultivation 

practices as currently-cultivated conventional corn varieties, including 1507, 59122, and 1507 x 

59122 Maize (USDA-APHIS, 2012e). As discussed in Subsection 2.2 – Agricultural Production 

of Corn, Pioneer 4114 Maize production is unlikely to change land acreage or any cultivation 

practices for conventional, transgenic, or non-transgenic corn production. It is expected that 

similar agronomic practices that are currently used for commercially available corn varieties, 

such as 1507, 59122, and 1507 x 59122 Maize, would also be used by growers of Pioneer 4114 

Maize. Agronomic practices that have the potential to impact air quality will be the same for 

Pioneer 4114 Maize as they are for corn products like 1507, 59122, and 1507 x 59122 Maize that 

are currently cultivated on U.S. cornfields.

Based on this information, USDA-APHIS concludes that the cultivation of Pioneer 4114 Maize 

is not expected to adversely affect air quality. 

4.3.4 Climate Change

Agriculture, including land-use changes associated with farming, is responsible for an estimated 

6% of all human-induced GHG emissions in the United States (US-EPA, 2012b). Agriculturerelated GHG emissions include CO2, N2O, and CH4, produced through the combustion of fossil 

fuels to run farm equipment; the use of fertilizers; or the decomposition of agricultural waste 

products, including crop residues, animal wastes, and enteric emissions from livestock. N2O 

emissions from agricultural soil management (primarily nitrogen-based fertilizer use) represent 

69% of all U.S. N2O emissions (US-EPA, 2012b). A comprehensive discussion of the 

contribution of agricultural practices to GHGs is provided in Subsection 2.3.4 – Climate Change.

Conservation tillage practices used in U.S. corn production have been identified as providing 

climate change benefits (see, e.g., Brenner et al., 2001). Conservation tillage, discussed above in 

Agronomic Practices (Subsections 2.2.2 and 4.2.2) and Soil Quality (Subsections 2.3.1 and 

4.3.1), in addition to providing benefits to soil quality, also has the benefit of increasing carbon 

sequestration in soils. Switching from conventional tillage to a no-till corn-soybean rotation in 

Iowa, for example, has been estimated to increase carbon sequestration by 550 kg/hectare (485 

lb/acre) per year (Paustian et al., 2000; Brenner et al., 2001; Towery and Werblow, 2010) .

4.3.4.1 No Action: Climate Change 

Under the No Action Alternative, Pioneer 4114 Maize would remain a regulated article.

Accordingly, environmental releases of Pioneer 4114 Maize would continue under the USDAAPHIS notification and permitting process.

As discussed in Subsection 4.1 – Scope of the Environmental Analysis Current, corn varieties 

similar to Pioneer 4114 Maize would continue to be cultivated in the United States under the No 

Action Alternative. These currently-available corn varieties include 1507, 59122, and in 

particular, 1507 x 59122 Maize. Consequently, agronomic practices associated with production 

of 1507, 59122, 1507 x 59122 Maize, and conventional corn varieties would continue. As 

discussed in Subsection 2.3.4 – Climate Change, these common agronomic practices contribute 

to GHG emissions, including tillage, cultivation, irrigation, pesticide application, fertilizer 

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applications, and use of agriculture equipment. Because these common agricultural practices are 

not expected to change under the No Action Alternative, these common agricultural practices are 

also not expected to change if Pioneer 4114 Maize remains a regulated article.

To the extent that U.S. corn growers are able to implement conservation practices, GHG 

emissions are expected to continue to be reduced commensurate with the air quality 

improvements anticipated from adoption of conservation tillage practices. For example, the USEPA has identified a net reduction in the sequestration of carbon in soil over a 20-year time 

scale, which it attributes to the declining influence of the Conservation Reserve Program which 

had encouraged growers to take marginal lands out of production (US-EPA, 2012c). To a certain 

extent, the US-EPA also noted that adoption of conservation tillage resulted in increases in 

carbon sequestration in soils on those croplands (US-EPA, 2012c). The highest rates of carbon 

sequestration in mineral soils occurred in the Midwest, which is the region with the largest area 

of cropland managed with conservation tillage (US-EPA, 2012c). This is in contrast to the 

highest emission rates from organic soils noted in the southeastern coastal region, the areas 

around the Great Lakes, and the central and northern agricultural areas along the West Coast

(US-EPA, 2012c). 

4.3.4.2 Preferred Alternative: Climate Change

Under the Preferred Alternative, a determination of nonregulated status of Pioneer 4114 Maize 

would not change the cultivation or agronomic practices, or agricultural land acreage associated 

with growing corn, and thus is expected to have the same effect on climate change as the No 

Action Alternative. To the extent that the cultivation of a corn variety exhibiting resistance to 

glufosinate ammonium allows a grower to minimize conventional tillage and adopt conservation 

tillage practices, the potential impacts associated with the Preferred Alternative would be the 

same as those under the No Action Alternative.

As discussed in Subsection 4.2.1 – Areas and Acreage of Corn Production, the cultivation of 

Pioneer 4114 Maize is not expected to convert new land to corn cultivation. As discussed in 

Subsection 4.2.2 – Agronomic Practices, the management practices associated with the 

cultivation of Pioneer 4114 Maize and hybrids based on that variety are anticipated to be the 

same as those for current cultivation of 1507, 59122 and the 1507 x 59122 Maize.

Based on these findings, there are no substantial differences between the No Action Alternative

and the Preferred Alternative on climate change.

4.4 BIOLOGICAL RESOURCES

4.4.1 Animal Communities

Corn production systems in agriculture are host to a variety of animal species. A number of 

insect pests as well as beneficial insects feed on corn plants or prey upon other insects inhabiting 

cornfields. Although cornfields generally are considered poor habitat for birds and mammals in 

comparison with uncultivated lands, the use of cornfields by birds and mammals is not 

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DRAFT PIONEER 4114 MAIZE

uncommon. This subsection discusses the potential consequences of the No Action and the 

Preferred Alternatives on animal communities associated with cornfields. 

4.4.1.1 No Action: Animal Communities

Mammals and Birds

Under the No Action Alternative, Pioneer 4114 Maize remains a regulated article. However, the 

proteins contained within Pioneer 4114 Maize (i.e., Cry1F, Cry34Ab1, Cry35ab1, and PAT) will

remain in the U.S. corn market, as these proteins are already contained in other cultivated GE 

corn varieties. This includes the cultivation of 1507 (Cry1F and PAT proteins), 59122

(Cry34Ab1, Cry35Ab1, and PAT proteins), and 1507 x 59122 (Cry1F, Cry34Ab1, Cry35Ab1, 

and PAT) Maize. Potential impacts of GE and non-GE corn production practices on non-target 

terrestrial (insect, bird, and mammal) and aquatic (fish, benthic invertebrate, and reptile) species 

would be unchanged. 

As discussed in Subsection 2.4.1 – Animal Communities, the majority of birds and mammals use 

corn as food and not for shelter, due to regular agricultural disturbances (e.g., use of agricultural 

machinery, application of pesticides, etc.). The exposure pathway for the majority of bird and 

mammal species to GE corn varieties is through consumption of corn grain. Existing GE corn 

varieties containing the same Cry and PAT proteins at Pioneer 4114 Maize, including 1507, 

59122, and 1507 x 59122 Maize, will continue to be commercially cultivated under the No 

Action Alternative. Consequently, birds and mammals will continue to be primarily exposed to 

these GE corn varieties and their respective introduced proteins through the consumption of corn

grain.

The Cry proteins in 1507 and 59122 Maize are derived from Bt subsp. aizawai (Cry1F) and Bt

strain PS149B1 (Cry 34Ab1 and Cry35Ab1), respectively (USDA-APHIS, 2012e). The 

modifying PAT enzyme, encoded by the pat gene, is derived from S. viridochromogenes

(Pioneer, 2011b). Both B. thuringiensis and S. viridochromogenes are naturally occurring soil 

bacteria and are not pathogenic. Animals are regularly exposed to these organisms and their 

components without adverse consequences (Hérouet et al., 2005; US-EPA, 2007a; US-EPA, 

2010b; US-EPA, 2010a; Pioneer, 2011b; US-EPA, 2012f). US-EPA considers animal exposure 

in the registration of pesticides under FIFRA, including the review of Cry proteins as PIPs.

When reviewing the toxicity of these Cry proteins as PIPs, the EPA considers acute oral 

exposure involving a pure preparation of the PIP at doses over 5,000 mg/kg bodyweight as well 

as chronic exposure tests using a diet where the PIP comprised 10% of the diet (US-EPA, 2010a; 

US-EPA, 2010b). The EPA has also evaluated environmental exposures based on laboratory 

studies to predict lowest observed effects concentrations (LOEC) and no observed effects 

concentrations (NOEC) (US-EPA, 2010a). In these studies, the EPA has found no overt signs of 

toxicity associated with anticipated exposures in field conditions (US-EPA, 2010a; US-EPA, 

2010b). USDA-APHIS has found no evidence that the presence of the Bt and pat genes or the 

accumulation of the Cry and PAT proteins would have any impact on animals, including animals 

beneficial to agriculture (USDA-APHIS, 2012e). Glufosinate is already being applied to corn.

As discussed in Subsection 2.2 – Agricultural Production of Corn, the use of glufosinate on 

corn has been steady, ranging from 2% to 6% of U.S. corn acreage (Pioneer, 2011b). The

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DRAFT PIONEER 4114 MAIZE

US-EPA first registered glufosinate ammonium in 2000 as a non-selective foliar herbicide 

for use on a wide range of crops (US-EPA, 2008b; US-EPA, 2008a). In 2008, the US-EPA

announced that it was undertaking a registration review of this product, and has published a 

final work plan for this process (US-EPA, 2008a). US-EPA’s assessments of the toxicity of 

glufosinate indicated a relatively low risk to animals (US-EPA, 2008b). On an acute exposure 

basis, glufosinate is considered practically nontoxic to birds, mammals, and insects; slightly 

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 (US-EPA, 2008b).

As of the March 2008 Glufosinate Summary Document Registration Review, there were 

insufficient data available on terrestrial plant toxicity for an ecological assessment to be 

completed (US-EPA, 2008b). Based on the data collected as of the 2008 review summary, 

however, the areas of concern are impacts to non-target plants, chronic toxicity to mammals, and 

the indirect impacts to terrestrial animals from potential alterations in aquatic plant communities 

(US-EPA, 2008b). The EPA requires additional plant toxicity and field dissipation studies to 

determine potential impacts of typical end-use products. Existing environmental assessments of 

the toxicity of glufosinate to animal species indicate a relatively low direct risk, but high risk to 

plants composing the animals’ habitat (US-EPA, 2008b). 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 (US-EPA, 2008b). For 

birds, glufosinate is practically non-toxic on an acute and sub-acute dietary basis; therefore, the 

risk potential is presumed to be low (US-EPA, 2008b). Non-target exposure for plants typically 

results from runoff or drift. Although animals also can be affected from runoff and drift, 

ingestion is often the most important exposure pathway. As discussed above in Subsection 4.3.3

– Air Quality, the US-EPA label provides measures to control drift. Adherence to label use 

restrictions will ensure that the use of the herbicide will not adversely affect animals or critical 

habitat; labeled uses of glufosinate are approved pending the outcome of the US-EPA’s 

ecological risk analysis (US-EPA, 2008a). 

Invertebrates

Under the No Action Alternative, non-target invertebrates will continue to be exposed to GE 

corn varieties and their respective introduced proteins. As discussed in Subsection 4.1 – Scope of 

the Environmental Analysis, GE corn varieties that contain the same introduced proteins as 4114 

Maize will continue to be cultivated. Additionally, glufosinate will also continue to be applied to 

U.S. corn acreage. Potential impacts related to non-target invertebrates will continue as it 

currently exists in U.S. corn production under the No Action Alternative.

The most relevant invertebrates in a cornfield are those that are pests of corn. Under the No 

Action Alternative, GE insect-resistant corn varieties, such as 1507, 59122, and 1507 x 59122 

Maize will continue to be available to U.S. corn growers for control of major insect pests, such 

as European corn borer or western corn rootworm. However, the efficacy of GE insect-resistant 

hybrids may decrease if resistance develops in the target insect population. Yield losses and corn 

lodging caused by rootworm pressure have been observed in limited areas of planted Btexpressing hybrids and have been attributed to resistance (Hodgson and Gassman, 2011).

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Under the No Action Alternative and discussed in Subsection 2.4.1.2 – Invertebrates, U.S. 

growers cultivating Bt corn varieties are required to adopt IRM strategies to delay the 

development of insect resistance as a result of continued exposure to Cry proteins. One of the 

key strategies required by the US-EPA involves the incorporation of refuges into their IRM 

practices (see, e.g., US-EPA, 2010f). The US-EPA has approved refuge strategies for 1507, 

59122 , and 1507 x 59122 Maize (US-EPA, 2010f). The refuge strategy is based on the concept 

that resistant insect pests will mate with susceptible pests from nearby refuges of host plants 

without Bt toxin, thus producing offspring that are susceptible to the Bt corn crop26 (Tabashnik, 

2008; Tabashnik et al., 2008). Refuge strategies can include a field or a block or strip of non-Bt

corn that does not contain a Bt trait (US-EPA, 2010f). Recently, the US-EPA also has approved

an integrated refuge strategy, named “refuge in a bag,” where non-Bt seeds are blended with the 

Bt corn products and planted randomly within the field to ensure that refuge requirements are 

followed (Pioneer, 2012).

Insect resistance to plant-incorporated Bt proteins has been reported (see, e.g., Blanco et al., 

2010; Storer et al., 2010; Gassmann et al., 2011; Kilman, 2011; Blake, 2012). Inherent resistance

to certain Bt toxins has been identified in wild target insect populations in several fields in Iowa, 

Puerto Rico and Australia (Blanco et al., 2010; Storer et al., 2010; Gassmann et al., 2011; 

Kilman, 2011; Blake, 2012). The areas where insect resistance have been reported reflect a very 

small proportion of the total acreage cultivated in Bt corn (several fields in Iowa as compared 

with 67% of the 96 million acres planted in Bt corn in 2012 as noted in Table 2-1.). It is 

important to note that where insect resistance has been identified in Bt cornfields, the 

development of insect resistance appears to be the result of growers’ failure to exercise 

appropriate management strategies to preserve and protect against insect resistance. In Puerto 

Rico, for example, fall armyworm was identified as resistant to the Cry1F protein (Blanco et al., 

2010; Storer et al., 2010). The corn varieties in which resistance was identified in Puerto Rico 

had been cultivated in the same fields for 12 consecutive production cycles, and typical IPM 

measures, including varietal rotation and refuge strategies were not well implemented (Storer et 

al., 2010). In Puerto Rico, this continuous, overlapping production exerts substantial selection 

pressure towards Bt-resistant insect pests. Similarly, in the Iowa reports, insufficient planting of 

refuge is believed to have contributed to the development of resistance (Gassmann et al., 2011).

In the absence of refuge plantings, non-resistant insects are less available to breed, increasing the 

likelihood of the development of resistance (Tabashnik, 2008; Tabashnik et al., 2008). In

response to the emergence of insect pest resistance noted in Puerto Rico, Pioneer and Dow 

AgroSciences stopped selling 1507 Maize in Puerto Rico and have worked with growers to 

implement a more robust integrated pest management program, including chemical insecticides

(US-EPA, 2010b) . 

Additionally, Gassmann et al. (2011) noted that the emergence of resistant corn rootworm was 

likely the result of the growers’ failure to adhere to the US-EPA’s refuge strategies to preserve Bt

effectiveness; in each of the cases of resistance, the same corn varieties had been cultivated for 

several consecutive years within the same fields (Gassmann et al., 2011). Gassmann found that 

26 Assuming that resistance is a recessive genetic trait.

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although corn rootworm had developed resistance to the Cry3Bb1 protein, no cross resistance 

was demonstrated to other Cry proteins, including Cry34Ab1/Cry35Ab1 (Gassmann et al., 

2011). The lack of cross resistance suggests that creating hybrid corn varieties accumulating 

multiple Cry proteins is likely to preserve beneficial insect-resistant traits in corn. Additionally, 

other common corn production practices may help in preserving the integrity of beneficial insectresistant traits. For example, crop rotation in corn conducted to optimize soil nutrition and 

fertility, may also reduce pathogen loads and control corn pests (IPM, 2004; IPM, 2007). Crop 

rotation practices have been described previously in Section 2.2.2.2 – Crop Rotation.

Widespread failure of control measures using Bt crops has not been observed, despite some 

evidence of Bt resistance, in part due to IRM strategies, including supplemental pesticide use and 

refuges (Tabashnik et al., 2008). In the case of Bt corn grown in the Corn Belt, refuge acres are 

typically 5% to 20% of the cornfield area, depending on the product’s requirements (US-EPA, 

2010f). Greenhouse and laboratory tests suggest that insects under intense selection pressure by 

Cry proteins over multiple generations may develop resistance rapidly in the absence of a refuge 

to sustain susceptible populations. These data in combination with the report of field resistance 

to a Bt product further emphasize the importance of effective refuges for resistance management 

(Meihls et al., 2008). Resistance management strategies, which are mandated by US-EPA’s 

terms of Bt corn product registrations (US-EPA, 2010f) have been developed for all Bt corn 

products to mitigate the risk of pest resistance and to implement additional measures if resistance 

occurs.

Despite the need for additional attentiveness to potential impacts of Bt-resistance in insect pests, 

professional advice given to growers is that multiple tactics do not necessarily need to be employed 

simultaneously. Thus, University of Illinois Extension staff (Gray, 2011a) suggest that neither Btexpressing corn hybrids with soil applied insecticides nor adult control the previous season before 

planting Bt hybrids should become standard treatments. Rather, rotation of crops, alternation of Btexpressing corn hybrids, insecticide use on conventional non-rootworm-resistant crops, or using 

pyramided hybrids, and adult rootworm suppression should all be considered (Gray, 2011a). 

Grower decisions should be based on corn price, identification of fields with high CRW 

populations, trait performance at the location, and whether other soil pests are present. Long term 

perspectives for managing rootworm populations and other pests need to be taken, along with a 

fully integrated approach (Gray, 2011b).

4.4.1.2 Preferred Alternative: Animal Communities 

Mammals and Birds

Under the Preferred Alternative, potential impacts to mammals and birds are not anticipated to 

be substantially different compared to the No Action Alternative. As discussed in Subsection 4.1

– Scope of the Environmental Analysis, Pioneer 4114 Maize is phenotypically identical to 

currently-cultivated corn varieties, such as 1507 x 59122 Maize.

As discussed in Subsection 4.2 – Agricultural Production of Corn, a determination of 

nonregulated status of Pioneer 4114 Maize is not expected to impact agronomic practices for the 

cultivation of corn. Pioneer anticipates Pioneer 4114 Maize might replace some of the acres 

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currently planted with products containing 1507 x 59122 Maize, but is not expected to cause new 

corn acres to be planted in areas that are not already in agricultural production (Pioneer, 2012). 

Accordingly, mammal and bird communities not already impacted by corn cultivation are not 

expected to be substantially impacted by a determination of nonregulated status of Pioneer 4114 

Maize compared to the No Action Alternative. In that regard, the potential exposure of animals 

to typical corn cultivation practices and the introduced proteins in Pioneer 4114 Maize under the 

Preferred Alternative is anticipated to be the same as under the No Action Alternative. 

As noted in Subsection 4.1 – Scope of the Environmental Analysis, the Cry1F, 

Cry34Ab1/Cry35Ab1 and PAT proteins contained in Pioneer 4114 Maize have been 

commercially available for a number of years. As seen in Table 4-1, many different GE corn 

varieties containing these proteins, including the 1507 x 59122 Maize, have been registered by 

the US-EPA. No impacts to animal communities associated with exposure to these proteins in 

corn have been reported (US-EPA, 2010b; US-EPA, 2010a). Consequently, because Pioneer 

4114 Maize contains identical genetic elements as 1507, 59122, and 1507 x 59122 Maize, it is 

unlikely that a substantial impact would occur on the bird and mammal community following 

consumption of Pioneer 4114 Maize grain under the Preferred Alternative compared to the No 

Action Alternative. A recent laboratory study in which mice were fed either a diet of 4114 maize 

or a diet of non-GE maize showed no significant differences in performances between the two 

groups (Delaney et al., 2013).

Pioneer has evaluated the potential allergenicity and toxicity of the proteins introduced in 

Pioneer 4114 Maize and found no meaningful amino acid similarities with known allergens or 

toxins (Pioneer, 2011b). This finding was to be expected, as these proteins have been cultivated 

for many years, including 1507 x 59122 Maize. These exposures are no different than those 

under the No Action Alternative. Further discussion on the potential impacts from the 

consumption of Pioneer 4114 Maize is presented in Subsection 4.6 – Animal Feed. 

A determination of nonregulated status of Pioneer 4114 Maize also is not expected to result in a 

change in the use of glufosinate on corn. GE corn varieties containing resistance to glufosinate 

has been available and cultivated commercially for many years under the Liberty® trade name 

(see http://www.aphis.usda.gov/biotechnology/not_reg.html USDA-APHIS, 2012b). The 

proposed application rates for glufosinate application on Pioneer 4114 Maize are identical to 

those currently approved for use on corn (Pioneer, 2012). A determination of nonregulated status 

for Pioneer 4114 Maize is not expected to require a change in the US-EPA registration or label 

for this herbicide (Pioneer, 2011b). Current label application rates and associated use restrictions 

for herbicides are designed by the US-EPA to minimize the potential impacts of the use of 

glufosinate to non-target organisms. USDA-APHIS assumes that the herbicide will be used in 

accordance with these label restrictions. Under the Preferred Alternative, there are no differences 

from the No Action Alternative in the use of glufosinate associated with cultivation of Pioneer 

4114 Maize.

Invertebrates

Under the Preferred Alternative, non-target invertebrates will continue to be exposed to the 

agronomic practices that are common in U.S. corn cultivation. In particular, non-target 

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invertebrates will continue to be exposed to the agronomic practices that are used to produce 

currently-available GE corn varieties because Pioneer 4114 Maize is functionally equivalent to 

currently available varieties, such as 1507 x 59122 Maize, and thus, requires similar growing 

practices.

Pioneer assessed the non-target impact of Pioneer 4114 Maize on beneficial organisms in the 

corn agroecosystem, including the ladybird beetles (Hippodamia convergens and Coleomegilla 

maculata), the Monarch butterfly (Danaus plexippus), parasitic wasps (Nasonia vitripennis), the 

green lacewing (Chrysoperla carnea), and the honeybee (Apis mellifera) (Pioneer, 2012)

(USDA-APHIS, 2012e). Pioneer did not report any impacts on the abundance or diversity of 

non-target beneficial organisms in the field (Pioneer, 2011b; USDA-APHIS, 2012e). Based on a 

review of this information, USDA-APHIS has found no evidence that the presence of the Bt and 

pat genes or the presence of the Cry and PAT proteins would have any impact on non-target 

invertebrates, including non-target invertebrates beneficial to agriculture under the Preferred 

Alternative compared to the No Action Alternative (USDA-APHIS, 2012e).

As discussed in Subsection 2.4.1.2 – Invertebrates and the No Action analysis in Subsection 

4.4.1.1, growers are required by the US-EPA to incorporate refuge strategies to delay the 

development of insect resistance from exposure to the Cry proteins (see, e.g., US-EPA, 2010f).

As noted in the No Action discussion in Subsection 4.4.1.1, the US-EPA has published such 

strategies for cultivating the 1507, 59122, and 1507 x 59122 hybrids. Because Pioneer 4114 

contains identical Cry proteins as these currently-available insect-resistant corn varieties and is 

phenotypically identical to 1507 x 59122 Maize (Pioneer, 2012), these refuge strategies would 

not change under the Preferred Alternative. Implementation of refuge strategies would be the 

same as the No Action Alternative as would currently-available and practices corn cultivation 

strategies to reduce selection pressure for Bt-resistance in insect pests.

Based on these findings, USDA-APHIS has determined that the impacts to the invertebrate 

community under the Preferred Alternative are the same as those under the No Action 

Alternative. 

4.4.2 Plant Communities 

The landscape surrounding a cornfield may be bordered by a number of vegetative communities, 

including other crop fields, woodland, fencerows, rangelands, and/or pasture/grassland areas. 

These plant communities may represent natural or managed plant buffers for the control of soil 

and wind erosion and also may serve as habitats for a variety of transient and non-transient 

wildlife species. 

Additionally, the surrounding plant landscape may also influence non-crop plants (i.e., weed 

species) that grow within a corn production field. In this context, weeds are those plants which, 

when growing in the field, compete with the crop for space, water, nutrients, and sunlight (IPM, 

2004; IPM, 2007; University of California, 2009). Weed control programs are important aspects 

of corn cultivation. The types of weeds in and around a cornfield will vary depending on the 

geographic region where the corn is grown. Additionally, corn grain may remain in a field and 

germinate the following season among corn or other crops. These corn plants are known as 

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volunteer corn plants. This subsection discusses the potential consequences of the No Action and 

the Preferred Alternatives on plant communities. 

4.4.2.1 No Action: Plant Communities

Under the No Action Alternative, Pioneer 4114 Maize will remain a regulated article. Plant 

species (i.e., weeds) that typically inhabit GE and non-GE corn production systems will continue 

to be managed through the use of mechanical and chemical control methods, as currently 

practiced. Multiple herbicides, including the herbicide glufosinate, will continue to be used on 

corn. Volunteer corn will continue to be controlled by the recommended ACCase inhibitors and 

ALS inhibitors (Hager, 2009).

Surrounding Landscapes and Other Vegetation in Cornfields

Under the No Action Alternative, plant communities surrounding a cornfield may be subject to 

off-site movement of pesticides as described in Subsections 2.3.2 – Water Resources, 2.3.3 – Air 

Quality, and 2.4.2 – Plant Communities. In particular, herbicides such as glufosinate may affect 

non-target plants through run off/leaching and spray drift.

As noted in Subsection 4.1 – Scope of the Environmental Analysis, corn varieties exhibiting 

resistance to glufosinate have been available commercially since 1996. Despite its 

availability, application volumes of glufosinate have remained low in comparison to 

glyphosate (Pioneer, 2012). Glufosinate label rates for application to resistant corn 

varieties are from 28 to 34 fluid oz. per acre, not more than twice per season with a 

maximum annual application of 62 fluid ounces per acre, applied post-emergent, using 

over-the-top broadcast or drop nozzles from emergence until the corn is 24” tall or in 

theV-7 growth stage (Bayer, 2012). The current label for glufosinate can be found 

at http://fs1.agrian.com/pdfs/Ignite_280_SL_Herbicide_Label5a.pdf

Surface water may be impacted by glufosinate residues transported by runoff under the No 

Action Alternative. Glufosinate may leach to groundwater under certain conditions (such as soils 

with high permeability and shallow groundwater), but glufosinate degrades rapidly in soil from 

microbial activity and is rarely found deeper than 15 centimeters from the soil surface 

(Senseman, 2007). Glufosinate is highly water soluble and stable in water and adsorption to 

suspended solids and sediment has been observed to be low to high (US-EPA, 2000; HSDB, 

2010). Biodegradation occurs in water bodies with a half-life greater than 64 days (US-EPA, 

2000). Although the EPA has determined that glufosinate use presents “no acute effects on 

terrestrial or ... aquatic plants”, EPA acknowledges potential impacts to non-target plants either 

from runoff (aquatic) or spray drift (terrestrial) (US-EPA, 2007b). The US-EPA has considered 

non-target plant communities in its environmental risk assessment of glufosinate use and has 

included label use restrictions and handling guidance intended to prevent impacts to mitigate 

potential impacts to aquatic and terrestrial plants (see, e.g., Bayer, 2012). Label restrictions 

specific to water resources include, for example, prohibiting applications directly to water 

(except as allowed for rice), managing proper disposal of equipment wash water, and adopting 

cultivation methods (e.g., no till) to limit runoff to surface water, and not applying the herbicide 

when rainfall is forecasted to occur within 48 hours (Bayer, 2012). 

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Spray drift, as discussed above in Subsection 4.3.3 – Air Quality, is a concern for non-target 

plants growing proximate to fields when herbicides are used (see, e.g., Sanvido et al., 2007). The 

risk of off-target glufosinate herbicide drift is recognized by the US-EPA, which has 

incorporated both equipment and management restrictions to address drift in the approved 

herbicide labels (US-EPA, 2007b; see Bayer, 2012). Contact herbicides like glufosinate can case 

spotting on non-target plants when spray droplets drift onto and impact leaf tissue, although total 

tissue death is uncommon unless the herbicide completely covers the leaf (Ruhl et al., 2008). The

US-EPA label for glufosinate addresses spray drift concerns with label language on spray droplet 

size, wind speeds, ambient temperature, avoidance of certain sensitive plants, and specific 

equipment requirements regarding boom length and height above the canopy (Bayer, 2012). For 

example, the label requires that the applicator only use the herbicide when there is minimal 

“...potential for drift to adjacent sensitive areas (e.g. residential areas, bodies of water, known 

habitats of threatened or endangered species, non-target crops) ... or in circumstances where drift 

to unprotected persons or to food, forage or other plantings ... can occur” (Bayer, 2012). These 

label use conditions by the US-EPA are intended to limit the potential impacts of glufosinate 

spray drift, and are not expected to change under the No Action Alternative.

Under the No Action Alternative, there are numerous weeds in cornfields and they may be 

controlled by current practices, as noted in Subsection 2.4.2 – Plant Communities. Additionally, 

herbicide-resistant weed biotypes, namely glyphosate-resistant weed biotypes may continue to 

occur under the No Action Alternative. The emergence of herbicide resistance is not a new 

occurrence; new weeds may emerge as cropping practices change and growers fail to recognize 

or properly identify a plant as a weed (Iowa State University Extension, 2003). Although 

herbicide resistance in weeds was recognized long before GE crops were introduced, recent 

changes in grower practices to take advantage of these GE crops have impacted this phenomenon 

(Owen et al., 2011a). The introduction of glyphosate-resistant crops, including corn, resulted in 

growers changing historical weed management strategies, substituting glyphosate for other 

herbicides and relying on a single herbicide, glyphosate, to control weeds in the field (Owen et 

al., 2011a; Weirich et al., 2011; Vencill et al., 2012). Over-reliance on glyphosate use as a single 

management technique for weed control resulted in the selection of weeds resistant to that 

technique (Owen et al., 2011a; Weirich et al., 2011). The development of herbicide-resistant 

weeds requires growers to diversify their weed management strategies. Some growers, faced 

with glyphosate-resistant weeds, have returned to tillage and other cultivation techniques to 

physically control these species when herbicides prove ineffective (Pioneer, 2012). Diversifying 

herbicide weed management strategies is an effective alternative to tillage for mitigating the 

evolution of weed resistance to herbicides (Wilson, 2011). An example of an additional herbicide 

that may be used to control glyphosate-resistant weeds is glufosinate, though other herbicides are 

available for use in corn.

Table 4-3 illustrates the comparative control of glyphosate-resistant and hard to control weeds 

based on records of glyphosate resistance, and potential glufosinate control. Diversifying 

herbicide weed management strategies is an effective alternative to tillage for mitigating the 

evolution of weed resistance to herbicides (Wilson, 2011). 

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Table 4-3. Comparative control of herbicide-resistant weeds. (IPM, 2007; Heap, 2012)

Weed Species

Hard to 

Control

GlyphosateresistantALSresistantGlufosinate 

controlled

Abutilon theophrasti (Velvetleaf) X

Amaranthus palmeri (Palmer amaranth)2 X X X

Amaranthus rudis (Tall or common waterhemp) X X X

Ambrosia artemisifolia (Common ragweed) X X X

Ambrosia trifida (Giant ragweed) X X X

Chenopodium album (common lambsquarters) X X

Conyza canadensis (Marestail) X X X

Eleusine indica (Goosegrass) X X X4

Ipomoea sp. (Morningglory species) X

Lolium multiflorum (Italian ryegrass) X X3 X X3

Lolium perenne (Perennial ryegrass) X X X X

Lolium rigidum (Rigid ryegrass) X X X X

Poa annua (Annual bluegrass) X X X

Sida spinosa (Prickly sida, Teaweed) X X

Solanum ptycanthum (Eastern black nightshade) X X

Sorghum halepense (Johnsongrass) X X X

Notes:

1. 2,4-D application rate of 560 to 1,120 g ae/hectare.

2. Requires a broader management plan.

3. Reported in Heap as exhibiting resistance to both herbicides in Oregon.

4. Resistance to glufosinate reported in malaysia (Heap, 2012)

Globally, only two weeds have been identified as resistant to glufosinate: Lolium multiflorum

(Italian ryegrass) and Eleusine indica (Goosegrass), with Lolium the only reported resistant weed 

in the United States (Heap, 2012). The Lolium species is a difficult to control weed in corn (see, 

e.g., King et al., 2012). This species also has been reported as resistant to glyphosate in certain 

locations, and has exhibited resistance to both herbicides in an Oregon location (Heap, 2012).

Control measures are available for this weed under the No Action Alternative, including the use 

of other herbicides, such as gramoxone and atrazine (King et al., 2012). 

Corn as a Weed or Volunteer

As discussed in Subsection 2.4.2 – Plant Communities, corn is not considered a weed in the 

United States (Crockett, 1977; Muenscher, 1980). Under the No Action Alternative, corn will 

remain non-weedy.

Corn has been identified as a volunteer when corn seeds remain in the field after harvest and 

successfully germinate (Beckett and Stoller, 1988; USDA-APHIS, 2012e) (see also Davis, 2009; 

Hager, 2009; Bernards et al., 2010; Johnson et al., 2010; Wilson et al., 2010; Stewart, 2011; 

Wilson, 2011).

The adoption of herbicide-resistant crops has changed the approaches which growers can use to 

reduce crop losses from volunteers (Beckie and Owen, 2007). In soybean fields cultivated in 

rotation with corn where the volunteer corn is glyphosate- or glufosinate-resistant, herbicides 

with alternate modes of action might be employed (e.g., glufosinate in LibertyLink® soybean to 

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control a Roundup Ready® glyphosate-resistant volunteer corn variety) (Minnesota, 2009; 

Bernards et al., 2010). Post-emergent grass herbicide that function as ACCase inhibitors also are 

recommended, including quizalofop, fluazifop, fenoxaprop, sethoxydim, and clethodim (Hager, 

2009; Bernards et al., 2010; Johnson et al., 2010). ALS inhibitors, such as the sulfonylureas, 

imidazolinone, and triazoloyrimidine also have been identified for potential control of 

glyphosate- or glufosinate-resistant corn (see, Hager, 2009; Wisconsin, 2011). Herbicide tank 

mix additives are recommended to increase on-plant spray retention and absorption (see Hager 

and McGlamery, 1997; Sandell et al., 2009; Johnson et al., 2010). Recommended additives 

include crop oil concentrate (COC), methylated seed oil (MSO), and ammonium sulfate (AMS) 

(Hager and McGlamery, 1997; Johnson et al., 2010; Monsanto, 2010). Imazethapyr has been 

identified to control up to 80% of the volunteer corn when the corn is still in early growth stages 

(Bernards et al., 2010). The ACCase inhibiting herbicides are to be applied prior to the corn 

reaching the 12 to 24 inch tall stage and the ALS herbicides are effective in controlling smaller 

(2 to 8 inch) corn (Minnesota, 2009; Monsanto, 2010).

GE corn varieties, such as 1507, 59122, and the 1507 x 59122 Maize are currently cultivated in 

the United States. These GE corn varieties, like any other non-GE or GE corn variety, possess 

the potential to become volunteers. These GE corn varieties, like conventional corn varieties,

may be controlled by mechanical cultivation as well as readily available herbicides or other 

graminicides (Wozniak, 2002). As discussed in Subsection 2.4.2.2 – Corn as a Weed or 

Volunteer, herbicides recommended for control of volunteer corn in soybeans and canola are the 

ACCase inhibitors and certain ALS inhibitors (Hager, 2009; Gunsolus and Stachler, 2010; 

Gunsolus and Porter, 2011). The ACCase inhibitors include two families of herbicides, the 

AOPP ACCases (e.g., the “fops,” such as quizalofop, fenoxaprop, and diclofop) and the 

cyclohexanediones (e.g., the “dims,” such as clethodim and sethoxydim) (Hager, 2009). 

Additionally, specific herbicide strategies to control corn volunteers in rotation with various 

crops are developed in consultation with local agronomists. For example, Gunsolus and Stachler 

(2004, Updated 2010) provide an overview of the various herbicide strategies recommended in 

North Dakota to control weeds in glyphosate-resistant corn cultivated in rotation with a wide 

range of crops, including corn, soybean, sugar beet, wheat, potato and dry bean. Under the No 

Action Alternative, these currently-available herbicides and strategies may control volunteer 

corn, such as volunteer corn derived from 1507, 59122, and 1507 x 59122 Maize.

4.4.2.2 Preferred Alternative: Plants 

The potential impacts to plant communities from a determination of nonregulated status of 

Pioneer 4114 Maize relates to both the potential impacts of the cultivation of Pioneer 4114 

Maize on other plant communities and the potential for this corn variety to become a weed or 

volunteer, thus interfering with other crop cultivation. These are addressed separately in the 

following subsections. 

Surrounding Landscapes and Other Vegetation in Cornfields

Under the Preferred Alternative, a determination of nonregulated status of Pioneer 4114 Maize is 

not anticipated to substantially impact vegetation surrounding a cornfield. As discussed in 

Subsection 4.2 – Agricultural Production of Corn, Pioneer 4114 Maize does not require different 

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agricultural management strategies from commercially-available corn varieties, like 1507 x 

59122 Maize, and is not expected to substantially affect the surrounding vegetation relative to 

the No Action Alternative. 

As noted in the No Action Alternative, the US-EPA has established label use restrictions to 

control runoff and spray drift during/following the application of glufosinate, including the 

application of glufosinate on 1507, 59122, and 1507 x 59122 Maize (see, e.g., Bayer, 2012).

There are no changes to the application rates or label required to cultivate Pioneer 4114 Maize 

(Pioneer, 2011b). Accordingly, the potential impacts to non-target plants associated with off-site 

herbicide movement under the Preferred Alternative are the same as the No Action Alternative.

The total volume of glufosinate used on corn has remained relatively steady in recent years, with 

2% to 6% of the total corn acreage treated with glufosinate between 2001 and 2011 (Pioneer, 

2012). To the extent that growers may cultivate Pioneer 4114 Maize in lieu of currently-available 

corn hybrids with identical traits (i.e. glufosinate-resistance and insect-resistance), such as 1507 

x 59122 Maize, the total volume of is not expected to change. There are no differences in this 

aspect under the Preferred Alternative compared to the No Action Alternative with respect to 

plant communities surrounding a corn field. 

The cultivation of Pioneer 4114 Maize is not expected to change weed management strategies 

already conducted by growers cultivating 1507, 59122, and 1507 x 59122 Maize (see. e.g., (De 

Schrijver et al., 2007)). These practices are consistent with those currently employed under the 

No Action Alternative to control weeds found within cornfields as well as those practices 

undertaken to protect plants located outside of the cornfield. Based on these findings, the 

potential impacts from a determination of nonregulated status of Pioneer 4114 Maize to 

vegetation surrounding cornfields are not expected to differ from the No Action Alternative.

Corn as a Weed or Volunteer

Agronomic studies conducted by Pioneer compared the weediness potential of Pioneer 4114 

Maize with conventional corn (Pioneer, 2011b; USDA-APHIS, 2012e). No differences were 

detected between Pioneer 4114 Maize and conventional corn in dormancy, germination, growth, 

reproduction, or interactions with pests and diseases. Similarly, none of the characteristics of 

Pioneer 4114 Maize confer any additional advantage as a volunteer from GE corn varieties, such 

as 1507 x 59122 Maize that are already commercially cultivated.

Accordingly, Pioneer 4114 Maize is not expected to be any weedier or to exhibit different 

volunteer traits than those described in the No Action Alternative. To the extent that Pioneer 

4114 Maize does become a volunteer in other corn or rotation crops, the management controls 

for this variety are expected to be similar to those currently used for control of 1507 x 59122

Maize volunteers as discussed in the No Action Alternative.

The well-established and broadly used agricultural protocols to control volunteer corn associated 

with Pioneer 4114 Maize are consistent with the practices currently employed under the No 

Action Alternative. Accordingly, the strategies to control potential volunteer 1507, 59122, and 

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1507 x 59122 Maize are anticipated to be equally applicable to Pioneer 4114 Maize under the 

Preferred Alternative (De Schrivjer, 2007).

Based on these findings, there are no anticipated differences in potential impacts between the No 

Action and the Preferred Alternative for plant communities.

4.4.3 Soil Microorganisms

In the cultivation of corn, potential impacts to soil microorganisms can arise from the agronomic 

practices in cultivating corn and from exposure to the introduced gene, protein, and composition 

of the corn variety if it is GE.

4.4.3.1 No Action Alternative: Soil Microorganisms

Under the No Action Alternative, Pioneer 4114 Maize remains a regulated article. As discussed 

in Subsection 4.2.2 – Agronomic Practices, corn cultivation practices are expected to remain as 

currently practiced. Growers will continue to have access to existing GE corn varieties (both 

lepidopteran-resistant and herbicide-resistant) as well as conventional corn varieties. Corn 

varieties based on 1507, 59122, and 1507 x 59122, the foundation for Pioneer 4114 Maize, will 

still be available to growers. Growers will continue to manage their crops, including 

implementing numerous management strategies to control pests and weeds. As discussed in 

Subsection 4.2.2 – Agronomic Practices, these current practices include the use of glufosinate for 

the control of certain weeds in the LibertyLink® varieties. Under the No Action Alternative, soil 

microorganisms will continue being exposed to GE corn varieties, their introduced proteins, and 

the agronomic practices currently used to cultivate these GE corn varieties.

The cultivation of GE crops has not been demonstrated to present environmental risks to soil 

microbial populations (Vencill et al., 2012). The diversity of microbial populations may be 

affected by these crops, but effects reported to date have been transient and minor (Dunfield and 

Germida, 2004; Vencill et al., 2012). 

Although Bt occurs naturally in soil, growth of Bt corn may cause a large increase in the amount 

of Cry endotoxin present in agricultural systems (Blackwood and Buyer, 2004). Many studies 

have assessed the potential effects of Bt proteins on microbial biomass, community structure, 

community function, and enzymatic processes. There is little evidence that soil microorganisms 

or soil ecosystem level processes are negatively impacted by Bt proteins in soil or by the 

cultivation of GE crops (Icoz and Stotzky, 2008). Because of concerns of the potential impacts of 

cultivating GE crops with Bt proteins on soil communities, the decomposition rates of GE crops 

with Bt proteins versus non-GE crops have been studied (Icoz and Stotzky, 2008). One study 

specifically characterized the potential effects of cultivating Cry1F- and Cry1Ab-expressing corn 

on microorganism community structure (assessed by shifts in phospholipid fatty acid profiles) or 

function (assessed through carbon substrate utilization profiles) in three different soil types 

(Blackwood and Buyer, 2004). Results from this study demonstrated that, under laboratory 

conditions, the structure and function of microorganism communities were not affected by Cry1F 

or Cry1Ab proteins. This is in contrast to some other studies examining the effect of Cry proteins 

on soil microorganisms (US-EPA, 2010b; US-EPA, 2010a). However, as noted in Subsection 

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4.3.1.1 – No Action: Agronomic Practices, the US-EPA notes that many of the early experiments 

evaluating Cry persistence in soil were based on bulk soil, rather than soils representing field 

conditions (US-EPA, 2010b; US-EPA, 2010a). These bulk soil experiments did not represent 

realistic field conditions, including degradation pathways in soil (US-EPA, 2010b; US-EPA, 

2010a). The US-EPA expects that degradation rates under field conditions may be higher than 

bulk soil experiments would suggest (US-EPA, 2010b; US-EPA, 2010a). Additionally, although 

the US-EPA found that the Cry proteins showed little degradation in soils with low pH (pH 5), 

the US-EPA also noted that corn does not grow well below pH 5.6; therefore, under most 

production conditions, corn would not be grown on soils that would inhibit the rate of 

degradation (US-EPA, 2010b; US-EPA, 2010a). 

Similarly, the Cry proteins in currently-cultivated Bt corn varieties, including 1507, 59122, and 

1507 x 59122 Maize, have been examined, and were found to not have any substantial impacts 

on soil microorganisms (USDA-APHIS, 2001; USDA-APHIS, 2005; US-EPA, 2010b; US-EPA, 

2010a). No short-term or long-term impacts to soil invertebrate populations exposed to Bt

proteins have been identified as a result of the wide-scale cultivation of Bt crops (Sanvido et al., 

2007).

Corn tissue degradation has been studied as a measure of potential impacts of Bt exudates on soil 

microorganism function. In one laboratory study, Bt corn tissue took longer to decompose than 

non-Bt corn tissues (Flores et al., 2005); however, other laboratory based studies have 

demonstrated that there is no difference between Bt and non-Bt corn decomposition rates 

(Hopkins and Gregorich, 2003). Studies conducted under field conditions show the 

decomposition rates of Bt cotton and Bt corn did not differ from the decomposition rates of nonBt cotton and corn (Lachnicht et al., 2004; Tarkalson et al., 2007).

Under the No Action Alternative, soil microorganisms are already exposed to the PAT protein 

contained in GE corn varieties no longer subject to the regulatory requirements of 340 Part 7 or 

the provisions of the Plant Protection Act of 2000. The PAT protein was evaluated in 1507 and 

59122 Maize and is not expected to have any substantial impact on non‐target organisms, 

including soil microorganisms (OECD, 1999; USDA-APHIS, 2001; Hérouet et al., 2005; USDAAPHIS, 2005; CERA, 2011).

Under the No Action Alternative, microorganisms will continue to be exposed to glufosinate in 

U.S. cornfields. As discussed in Subsection 4.2.2 – Agronomic Practices, glufosinate is one of 

many herbicides applied on U.S. corn acres. Soil microbes rapidly degrade glufosinate to CO2 

and natural phosphorus compounds (US-EPA, 2008b). Glufosinate applications may impact soil 

microbe communities, although the reported research yields differing results (see, e.g., Gyamfi et 

al., 2002; Lupwayi et al., 2004; Wibawa et al., 2010). For example, Gyamfi et al (2002) suggest 

that some of these microbial population shifts may be caused by the increase of herbicidedegrading microbes following application; whereas, other research suggests that glufosinate 

inhibits the activity of cultivar pathogens such as bacterial blight (Pline, 1999) and grapevine 

downy mildew (Plasmopara viticola) (Kortekamp, 2010).

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4.4.3.2 Preferred Alternative: Soil Microorganisms

Under the Preferred Alternative, soil microorganisms are unlikely to be substantially affected by 

a determination of nonregulated status of Pioneer 4114 Maize compared to the No Action 

Alternative. As discussed in Subsection 4.1 – Scope of the Environmental Analysis, Pioneer 

4114 Maize is phenotypically identical to 1507 x 59122 Maize. Accordingly, soil 

microorganisms are already exposed to the cultivation practices and introduced proteins in 

Pioneer 4114 Maize. There is no evidence that environmental effects caused by two parent 

genes in a stacked combination, will be any different than the effects caused by the two genes, 

cultivated separately (De Schrijver et al., 2007).

As discussed in Subsection 4.2.2 – Agronomic Practices, a determination of nonregulated status 

of Pioneer 4114 Maize is not expected to result in changes in corn agronomic practices. An 

example of this are the agronomic inputs associated with the cultivation of Pioneer 4114 Maize. 

Growers have the option to include glufosinate in their weed control strategies if they adopt 

Pioneer 4114 Maize. However, this change in weed management strategy is no different than that 

under the No Action Alternative, as corn varieties containing the same herbicide-resistant and 

insect-resistant proteins as Pioneer 4114 Maize are already on the market (e.g., 1507, 59122, and 

1507 x 59122 Maize). This means that soil microorganisms are already exposed to glufosinate 

and the Cry proteins in Pioneer 4114 Maize. 

Soil microorganisms rapidly degrade glufosinate to CO2 and natural phosphorous compounds 

(US-EPA, 2008b). USDA-APHIS does not anticipate that the use of glufosinate on Pioneer 4114 

Maize will have an adverse impact on soil microorganisms. Accordingly, soil microorganisms 

will continue to experience typical corn agronomic practices and are not expected to be 

substantially impacted by agronomic practices used to cultivate Pioneer 4114 Maize.

The insect-resistant and herbicide-resistant events contained by Pioneer 4114 Maize have been 

available commercially since 2006 with the development of the 1507 x 59122 variety (Pioneer, 

2012). As noted in Table 4-1, a number of commercial hybrids based on this variety are currently 

available. Soil microorganisms are already exposed to the Cry and PAT proteins from exudates 

as well as decomposing plant matter. Consequently, a determination of nonregulated status of 

Pioneer 4114 Maize is not expected to substantially change soil microorganism exposure 

currently experienced under the No Action Alternative. Additionally, because soil organisms are 

already being exposed to the introduced proteins in Pioneer 4114 Maize, no impacts to 

microorganisms are anticipated from a determination of nonregulated status of Pioneer 4114 

Maize.

Based on these factors, USDA-APHIS does not anticipate substantial impacts to soil 

microorganisms under the Preferred Alternative. As the herbicide glufosinate is registered 

currently for use on corn, and the traits expressed by Pioneer 4114 Maize are already 

commercially available, substantial differences between the No Action Alternative and the 

Preferred Alternative with regard to soil microorganisms are unlikely.

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4.4.4 Biological Diversity 

4.4.4.1 No Action: Biological Diversity 

As discussed in Subsection 2.4.4 – Biological Diversity, currently commercialized GE crops 

have reduced the impacts of agriculture on biodiversity through current use of conservation 

tillage practices, reduction of insecticide use, the use of more environmentally benign herbicides, 

and increasing yields to alleviate pressure to convert additional land into agricultural use (Young 

and Ritz, 2000; Jasinski et al., 2003; Carpenter, 2011). For GE crops, like corn, insecticide 

applications are substantially reduced with the cultivation of Bt varieties, which has been shown 

to contribute to natural enemy conservation, a substantial part of biodiversity in corn cultivation 

(see, e.g., Romeis et al., 2006).

Under the No Action Alternative, Pioneer 4114 Maize will continue to be a regulated article. 

Growers and other parties who are involved in production, handling, processing, or consumption 

of corn would continue to have access to existing nonregulated herbicide-resistant corn varieties, 

pest-resistant varieties, stacked varieties presenting both, and conventional corn varieties. These 

currently available varieties include 1507, 59122, and 1507 x 59122 Maize, which contains all of 

the traits of Pioneer 4114 Maize. The consequences of current agronomic practices associated 

with corn production, both traditional and GE varieties, on the biodiversity of plant and animal 

communities would likely not be altered. 

Cultivation of GE crops engineered to accumulate insecticidal proteins or tolerate herbicide 

application for weed management (including 1507, 59122, and 1507 x 59122 hybrid varieties 

already in cultivation) may influence local biodiversity, although distinguishing direct and 

indirect impacts of agronomic practices is difficult (see, e.g., Marshall et al., 2002; Ponsard et al., 

2002). For example, some studies have shown Bt proteins in GE crop exudates do not persist, but 

may degrade differently in different soil types (Carpenter, 2011). The difference in degradation 

appears to be primarily the result of differences in soil microbial activity, which in turn is 

dependent on soil type, season, crop species, crop management practices, and other 

environmental factors that vary with location and climate zones (Carpenter, 2011). These sitespecific differences make it difficult to clearly demonstrate impacts to soil biodiversity across 

entire crop systems. In another example, reductions of biological control organisms are seen in 

some Bt crops, but are caused by reduction of the pest host population following transgenic 

pesticide expression in the GE crop plant (Naranjo, 2009). As discussed in Subsections 4.4.1 –

Animal Communities, 4.4.2 Plant Otherwise Communities, and 4.4.3 Soil Microorganisms, there 

is no evidence that exposure to the Cry and PAT proteins in currently cultivated crops impacts 

animals, plants or soil microorganisms; biodiversity of an agricultural setting is constituted by 

the presence of these organisms.

Adoption of Bt crops has been associated with a reduction in the application of insecticides to 

control various insect pests (Carpenter, 2011; Brookes and Barfoot, 2012; Brookes et al., 2012) . 

Such a reduction in insecticide applications would bring a corresponding positive impact to 

biodiversity (Carpenter, 2011). 

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Although herbicide use potentially affects biodiversity, the application of pesticides in 

accordance with US-EPA registered label uses and careful management of chemical spray drift 

minimizes the potential biodiversity impacts from their use. The US-EPA has considered this in 

its registration and has established label use restrictions to minimize glufosinate drift (see Bayer, 

2012). Glufosinate is deemed non-toxic to birds, mammals, and insects; slightly non-toxic to 

freshwater fish; moderately toxic to estuarine/marine fish; moderately toxic to freshwater and 

estuarine/marine invertebrates; and toxic to terrestrial and aquatic plants (US-EPA, 2008b). 

Glufosinate is already used in corn, including corn based on the 1507, 59122 and the 1507 x 

59122 hybrid.

4.4.4.2 Preferred Alternative: Biological Diversity

Pioneer has presented results of agronomic field trials comparing Pioneer 4114 Maize 

conventional corn. The results suggest that there are no meaningful differences in agronomic 

attributes between Pioneer 4114 Maize and conventional corn (Pioneer, 2011b; Pioneer, 2012). 

Therefore, a determination of nonregulated status of Pioneer 4114 Maize is not expected to 

change agronomic practices. As noted in the introduction to this section, the commercial hybrid 

1507 x 59122 Maize, the foundation for Pioneer 4114 Maize traits, has been cultivated 

commercially for many years with no reports of impacts to animal or plant communities. There is 

no evidence that environmental effects caused by two parent genes in a stacked combination, 

will be any different than the effects caused by the two genes, cultivated separately (De Schrijver 

et al., 2007).

As discussed above in Subsection 4.2 – Agricultural Production of Corn, Subsection 4.4.1 –

Animal Communities, and Subsection 4.4.2 – Plant Communities, a determination of 

nonregulated status of Pioneer 4114 Maize will continue the use of glufosinate in U.S. corn. 

Glufosinate is already labeled for use in corn, and may be applied to any of the Liberty® corn 

varieties. A change in label is not required to apply glufosinate to Pioneer 4114 Maize (Pioneer, 

2011b). Increases in glufosinate use are unlikely, as Pioneer 4114 Maize is anticipated to replace 

some 1507 x 59122 Maize plants that are already cultivated as part of weed management strategy 

incorporating glufosinate. 

Animals, plants, and microorganisms’ exposure to the Cry and PAT proteins in Pioneer 4114 

Maize will be no different than exposure occurring under the No Action Alternative associated 

with cultivation of 1507, 59122 and the 1507 x 59122 Maize. Similarly, animals, plants and 

microorganisms associated with these fields are already exposed to glufosinate. As noted in 

Subsection 4.2 2 – Agricultural Production of Corn, Pioneer does not seek a change in the 

application or use of glufosinate for the cultivation of Pioneer 4114 Maize (Pioneer, 2011b).

Based on these findings, the potential impacts to biodiversity of plant and animal communities 

from the determination of nonregulated status of Pioneer 4114 Maize are similar to those from 

current conditions under the No Action Alternative.

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4.4.5 Gene Movement 

Vertical gene flow, or introgression, is the movement of genes to sexually compatible relatives 

and their subsequent expression (Ellstrand, 2003; Quist, 2010). Horizontal gene transfer is the 

stable movement of genes from one organism to another without reproduction or human 

intervention (Keese, 2008; Quist, 2010). 

4.4.5.1 Vertical Gene Flow – Movement to Other Varieties and Corn Relatives

No Action – Vertical Gene Flow

Under the No Action Alternative, conventional and GE transgenic corn production will continue, 

including the current cultivation of 1507 59122 and 1507 x 59122 Maize. The possibility of gene

movement from cultivated corn varieties into native or feral populations of Zea species or wild 

or weedy relatives of corn has been evaluated by the US-EPA and determined not to be a 

concern in the continental United States (US-EPA, 2010e). Vertical gene flow from currently 

cultivated corn varieties in the United States, including 1507, 59122, and 1507 x 59122 Maize 

varieties, to U.S. populations of Zea or Tripsacum species is not likely, with the limited 

exception of potential gene flow to feral populations of Zea mays ssp. parviglumis in Florida and 

to a lesser extent, Tripsacum floridanum, also in Florida. Differences in flowering time between 

corn and these species, and current geographic separation of these species from the majority of 

U.S. corn production, make the occurrence of natural crosses in the U.S. very minor (Galinat, 

1988; Doebley, 1990, Doebley, 1990 #539; Baltazar et al., 2005; Kermicle and Evans, 2005; 

Ellstrand et al., 2007b). If hybridization were to occur, the resulting hybrids are often sterile or 

have greatly reduced fertility, the hybrids are less fit, do not disseminate seed, have a reduced 

reproductive capacity, and none can withstand even the mildest winters (OECD, 2003; USDAAPHIS, 2012e). Additionally, hybridization between corn and Tripsacum is not likely in the 

absence of specialized hybridization techniques in controlled conditions, strongly suggesting that 

hybridization is unlikely in typical field conditions (Mangelsdorf, 1974; Russell and Hallauer, 

1980; Galinat, 1988). Consequently, gene flow between current commercially available corn 

cultivars and its relatives both GE and non-GE (including those Tripsacum species listed in

Subsection 2.4.5 – Gene Movement) is unlikely under the No Action Alternative.

Gene movement between sexually compatible corn varieties and related species is no greater for 

currently cultivated GE varieties, including 1507, 59122, and the 1507 x 59122 Maize than it is 

for other non-GE or GE cultivars (USDA-APHIS, 2012e). Many factors limit the likelihood of 

gene movement between corn varieties, including those noted below.

• The pat gene does not impart an agronomic advantage whereby a greater potential for 

weediness or invasiveness would result should introgression occur.

• Neither GE nor non-GE corn cultivars form self-sustaining populations outside of 

cultivation because of limitations in seed dispersal, germination, and seasonal 

requirements (US-EPA, 2010e).

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• Spatial and temporal isolation can be one of the most effective barriers to gene exchange 

between com crop cultivars (Mallory-Smith and Zapiola, 2008). Current practices for 

maintaining the purity of hybrid seed production in corn are typically successful for 

maintaining 99% genetic purity, though higher instances of outcrossing can occur 

(Ireland et al., 2006). The corn industry has measures in place as part of seed certification 

and varietal protection to restrict pollen movement and gene flow between cornfields 

through the use of isolation distances, border and barrier rows, the staggering of planting 

dates, detasseling and hand pollination, and various seed handling, transportation and 

handling procedures (see also, AOSCA, 2010).

The reproductive morphology of corn encourages cross-pollination between corn plants and 

there is no evidence (genetic or biological barriers) to indicate that gene flow is inherently 

restricted between GE and non-GE corn. Gene flow between corn varieties is most likely to 

occur during cultivation as well as the handling and processing of corn (Thomison, 2009; Coulter 

et al., 2010; Mallory-Smith and Sanchez-Olguin, 2011). Corn is a cross-pollinating crop in which 

most pollination results from pollen dispersed by wind and gravity (Thomison, 2009). Factors 

controlling pollen-mediated gene flow include the outcrossing rate of recipients, pollen loads of 

donors, pollen competition between donors and recipients, and local weather/climate conditions 

(e.g., wind, precipitation) (Lu, 2008). As discussed above in Subsection 4.2.3 – Organic Corn 

Farming and Specialty Corn Systems, growers concerned about cross pollination can incorporate 

standard management methods to control pollen drift in order to manage this form of gene flow. 

Gene flow through handling and processing is problematic if product handling facilities where 

corn is dried, cleaned, and stored do not maintain adequate separation between varieties 

(Mallory-Smith and Sanchez-Olguin, 2011). Such admixtures at these facilities have been 

reported for varieties of GE corn and conventional corn (Mallory-Smith and Sanchez-Olguin, 

2011). This form of gene flow occurs irrespective of the variety of corn being cultivated, and is 

not a new concern associated with the determination of nonregulated status of this variety. As 

discussed above in Subsection 4.2.3 – Organic Corn Farming and Specialty Corn Production, 

procedures for managing identity of specific varieties are already in place to minimize gene flow 

challenges arising from admixtures during handling. 

Vertical Gene Flow – Preferred Alternative

As discussed in Subsection 4.2 – Agricultural Production of Corn, cultivation practices for 

Pioneer 4114 Maize are no different from those corn varieties currently cultivated under the No 

Action Alternative. These corn varieties include 1507, 59122, and 1507 x 59122 Maize. Pioneer 

has compared the morphology of Pioneer 4114 Maize with other corn varieties, including 1507 

and 1507 x 59122 Maize, and has identified no biologically meaningful differences in 

reproductive biology (Pioneer, 2011b; Pioneer, 2012; USDA-APHIS, 2012e). Accordingly, as 

compared to the No Action Alternative, there are no new management practices or reproductive 

characteristics that would affect the barriers to gene flow in corn. The management practices to 

mitigate vertical gene flow described in the No Action Alternative would be the same as those 

required under the Preferred Alternative (see, e.g., (De Schrijver et al., 2007)). However, as 

discussed in Subsection 4.4.2 – Plant Communities, in the unlikely event that the pat gene from 

Pioneer 4114 Maize should pass to progeny through cross pollination, and the PAT herbicide 

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resistance protein is expressed in that cross-pollinated hybrid, and that hybrid becomes a 

volunteer, that volunteer could still be controlled by other readily available herbicides. 

Based on these findings, there are no substantial differences in Vertical Gene flow between the 

No Action Alternative and the Preferred Alternative following a determination of nonregulated 

status of Pioneer 4114 Maize.

4.4.5.2 Horizontal Gene Transfer – Movement to Unrelated Species

Horizontal Gene Transfer – No Action Alternative

As discussed in Subsection 2.4.5 – Gene Movement, there is no evidence of naturally occurring

transgene movement from transgenic crops to sexually incompatible species (USDA-APHIS, 

2012e). Horizontal gene transfer and consequent expression of DNA from one plant to another 

plant or other phyla (e.g., species of bacteria) are both unlikely to occur (Keese, 2008). This 

event would require physical relocation of the complete genetic material from the transgenic 

plant to the new location, including not only the genes which code for the production of specific 

proteins, but also those portions of the genome which regulate the activity of those genes (Keese, 

2008). There are no known naturally occurring vectors (such as plasmids, phages, or 

transposable elements) that could be responsible for inter-domain gene transfer, and there is little 

evidence that eukaryotic cells are naturally capable of stably incorporating genes from the 

environment into their genome (Brown, 2003). Although viruses do move genetic material, all 

viruses that infect higher plants have small ribonucleic acid (RNA) or DNA genomes, usually 

with fewer than 20 encoded proteins (Keese, 2008). These viruses are therefore constrained as to 

the type and size of novel genetic material which can be acquired by horizontal gene transfer

(Keese, 2008).

Two soil bacterial species commonly associated with plants, Agrobacterium and Rhizobium,

have been evaluated to determine the probability of horizontal gene transfer between the 

bacterium and its host plants. Agrobacterium moves its genes from its bacterial plasmid to the 

plant, causing the plant to produce crown gall (abnormal outgrowth) (University of Illinois, 

2010). Rhizobium aids in nitrogen fixation in legume nodules (Wilkinson and Elevitch, 2011). 

The genomes of both bacteria have been sequenced, and the sequenced genes evaluated for 

exogenous genes (Kaneko et al., 2000; Wood et al., 2001; Kaneko et al., 2002). Despite what 

would appear to be millennia of symbiotic relationships between these bacteria and their host 

plants, there is no evidence that these organisms contain genes derived from plants; in cases 

where review of sequence data implied that horizontal gene transfer occurred, these events are 

inferred to have occured on an evolutionary time scale in the order of millions of years (Koonin 

et al., 2001; Brown, 2003). Transgene DNA promoters and coding sequences are optimized for 

plant expression, not bacterial expression. Horizontal gene transfer, resulting in the relocation of 

entire transgenes including the regulatory portions of the DNA (those parts of the DNA which 

code for the production of the specific proteins in that relocated transgene) never has been shown 

to occur in nature (Clarke, 2007; Stewart, 2008). Thus, even if horizontal gene transfer occurred, 

proteins associated with these transgenes are not likely to be produced in the new host organism. 

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Horizontal gene transfer may also occur within organisms of the same Kingdom. Horizontal gene 

transfer has been implicated in the incorporation of a specific genetic sequence in the parasitic 

plant purple witchweed (Striga hermonthica), which infests cereal fields including corn and 

sorghum (Sorghum bicolor) (Yoshida et al., 2010). Yoshida concluded that the incorporation of 

the specific genetic sequence (with an unknown function) occurred between sorghum and purple 

witchweed before speciation of purple witchweed (S. hermonthica) and related cowpea 

witchweed (S. gesnerioides), a parasitic plant of dicots, from their common ancestor. In other 

words, horizontal gene transfer between a parasitic plant and its host is an extremely rare event

and like potential horizontal gene transfer events between plants and bacteria, normally occurs 

over very large time scales. Furthermore, S. hermonthica is not found in the United States and S. 

asiatica (another related parasite of cereal crops) is only present in North Carolina and South 

Carolina (USDA-NRCS, 2011b). The Striga that occurs in the United States is listed as a Federal 

noxious weed, and is restricted in its distribution - largely due to an USDA-APHIS containment, 

quarantine, and eradication program (Nickrent and Musselman, 2004, Updated 2010 available at 

http://www.apsnet.org/edcenter/intropp/pathogengroups/pages/parasiticplants.aspx). 

Horizontal Gene Transfer – Preferred Alternative

Pioneer has evaluated the morphological and compositional characteristics of Pioneer 4114 

Maize with the 1507 and 1507 x 59122 Maize, and has determined that any differences are not 

biologically meaningful (Pioneer, 2011b; Pioneer, 2012; USDA-APHIS, 2012e). The 

characteristics of Pioneer 4114 Maize are phenotypically identical to corn varieties already 

cultivated, including 1507 x 59122 Maize. Under the Preferred Alternative, there are no changes 

in Pioneer 4114 Maize that would impact the barriers to horizontal gene transfer compared to the

No Action Alternative. 

Based on the findings noted in the No Action Alternative, USDA-APHIS considers the 

horizontal gene transfer from Pioneer 4114 Maize to unrelated species to be unlikely under the 

Preferred Alternative, and the same as potential horizontal gene transfer from existing GE and 

non-GE corn varieties (see, e.g., De Schrivjer, 2007).

4.5 PUBLIC HEATH

4.5.1 Human Health

The assessment of potential human health effects from GE crops considers two aspects of the 

crop: the introduction of an herbicide when the crop contains an herbicide-resistant trait, and 

potential changes in crop composition associated with newly introduced proteins. This 

subsection provides a summary of this analysis, with discussion of farm worker safety in 

Subsection 4.5.2. 

As noted in Subsection 4.1 – Scope of the Environmental Analysis, the introduced proteins in 

Pioneer 4114 Maize, notably Cry1F, Cry34Ab1, Cry35Ab1, and PAT, have been previously 

reviewed, and corn varieties containing these events are already widely cultivated. Moreover, 

there are several previous assessments of the indirect effects associated with the exposure to 

glufosinate. Humans are already likely exposed to the agronomic practices related to Pioneer 

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4114 Maize and the introduced proteins in Pioneer 4114 Maize. Accordingly, to facilitate the 

review of this section, and to reduce redundancy, these impacts are discussed in the context of 

the No Action Alternative. 

4.5.1.1 No Action: Human Health 

Under the No Action Alternative, Pioneer 4114 Maize would remain a regulated article and 

would not be widely cultivated in the United States. However, human exposure to the agronomic 

practices associated with Pioneer 4114 Maize and its introduced proteins would not change. 

Growers already cultivate GE maize varieties that contain the Cry1F, Cry34Ab1, Cry35Ab1 and 

PAT proteins (e.g., 1507, 59122, and 1507 x 59122 Maize varieties), meaning that humans will 

continue to be exposed to those proteins. The Cry1F protein and its associated genetic elements 

were introduced with 1507 Maize, which had a determination of nonregulated status by USDA, 

registered by the EPA, and reviewed by the US-FDA in 2001 (US-FDA, 2001; USDA-APHIS, 

2001; US-EPA, 2010f; Pioneer, 2011b). The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and 

their associated genetic elements were introduced in 59122 Maize, which was reviewed by USFDA in 2004, had a determination of nonregulated status by USDA in 2005, and registered by

US-EPA since 2005 (US-FDA, 2004; USDA-APHIS, 2005; US-EPA, 2010f; Pioneer, 2011b). 

Maize expressing the PAT protein has had a nonregulated status since 1995 and commercially 

cultivated in the United States since 1996 (USDA-APHIS, 1995).

Maize varieties based on 1507, 59122, and 1507 x 59122 Maize are anticipated to still be 

cultivated. As noted previously in Subsection 4.2.2 – Agronomic Practices, in 2010, 

approximately 16% of the commercial corn acreage was planted with a 1507 x 59122 Maize

(Pioneer, 2011b). With regard to glufosinate use on corn, in 2010, approximately 2% of the total 

corn acreage was treated with glufosinate (USDA-NASS, 2011a). Consumers would continue to 

be exposed to glufosinate and its residues on those corn acres treated with that herbicide, and 

consumers also will be exposed to the same Cry proteins incorporated within the Pioneer 4114 

Maize.

USDA-APHIS’ evaluation of potential human health effects considers potential impacts 

associated with incidental exposure to the pesticides applied to the GE crop and an analysis of 

the crop composition associated with the GE agricultural crop. USDA-APHIS considers the USEPA and the US-FDA regulatory assessments when evaluating these aspects of potential impacts 

to human health. 

Glufosinate Use and Exposure

USDA-APHIS considers the US-EPA’s registration of pesticides when evaluating the potential 

consequences arising from a determination of nonregulated status of a GE crop. The US-EPA

considers human health effects from the use of pesticides when it evaluates the registration of 

pesticides. Prior to pesticide registration, including the new use of a previously-registered 

pesticide, US-EPA must determine that the pesticide will not cause unreasonable adverse effects 

on human health (and the environment, and non-target species). Frequently, the US-EPA will 

establish label restrictions to mitigate or alleviate any potential impact on human health and the 

environment. Once registered, a pesticide may not legally be used unless the use is consistent 

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with the guidelines and application restrictions and precautions on the pesticide's label. The 

pesticide registration label is intended to provide appropriate use instructions so as to protect 

human health. US-EPA uses the standard of “no unreasonable adverse effects” in making its 

registration determinations. FIFRA defines this term as follows—

UNREASONABLE ADVERSE EFFECTS ON THE ENVIRONMENT — The 

term ‘‘unreasonable adverse effects on the environment’’ means (1) any 

unreasonable risk to man or the environment, taking into account the economic, 

social, and environmental costs and benefits of the use of any pesticide, or (2) a 

human dietary risk from residues that result from a use of a pesticide in or on any 

food inconsistent with the standard under section 408 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 346a) ...(See; FIFRA, Section 2(bb), 7 U.S.C. 

§136(bb)) 

EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in 

place for all populations of non-target species potentially exposed to pesticides, including 

humans. This risk assessment included acute, short-term and chronic aggregate risk assessments 

as well as occupational and residential exposure risk assessments. The US-EPA is currently 

collecting and reviewing data supporting a reevaluation of the “acute and/or chronic dietary 

analysis” as part of its registration review of glufosinate (US-EPA, 2008a). 

These assessments provide US-EPA with information needed to develop label use restrictions for 

the pesticide. Growers are required to use pesticides such as glufosinate ammonium consistent 

with the application instructions provided on the US-EPA-approved pesticide label (Bayer, 

2012). These label restrictions carry the weight of law and are enforced by US-EPA and the 

states (FIFRA 7 USC 136j (a)(2)(G) Unlawful Acts).

As discussed in Subsection 2.2.2.3 – Agronomic Inputs, the use of glufosinate on total corn acres 

has remained stable and low over the past decade, with between 2% and 6% of the total U.S. 

corn acreage treated with glufosinate (Pioneer, 2011b). This includes application of glufosinate 

on GE maize varieties already containing the glufosinate-resistant trait, such as 1507 x 59122 

Maize. Additionally, as noted above, corn expressing the PAT protein and resistant to glufosinate 

has been commercially available since 1996. The application of glufosinate to corn is not a new 

practice. Under the No Action Alternative, the application of glufosinate to corn acreage is 

expected to follow U.S. corn growers’ adoption of glufosinate-resistant corn varieties, such as

1507, 59122, or 1507 x 59122 Maize. 

As glufosinate is currently applied to some U.S. corn acreage, glufosinate residue may occur on 

some U.S. corn grains. As noted in Subsection 1.3 – Coordinated Framework Review and 

Regulatory Review, before allowing the use of a pesticide on food crops, the US-EPA sets a 

tolerance, or maximum residue limit, for the amount of pesticide residue allowed to remain on or 

in each treated food commodity (US-EPA, 2012f). US-EPA is required to reach a safety 

determination based on a finding of reasonable certainty of no harm under the FFDCA. To make 

this finding, US-EPA considers the toxicity of the pesticide and its breakdown products, how 

much pesticide is applied and the frequency of application, and how much pesticide remains on 

the food by the time it is marketed and prepared (US-EPA, 2012f). The US-EPA has established 

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exemptions for tolerance for glufosinate (US-EPA, 2010d). The US-EPA’s tolerance exemptions 

for glufosinate in corn are 6.0 parts per million (ppm) for corn stover, 4.0 ppm for corn forage, 

and 0.20 ppm for corn grain (US-EPA, 2010d). The establishment of these glufosinate tolerances 

by the US-EPA ensure safety of foods treated with glufosinate and are made following risk 

assessments that reflect real-world consumer exposure as closely as possible (US-EPA, 2012e).

Additionally, the processing of corn-based food products, including those derived from corn 

varieties treated with glufosinate, has been demonstrated to reduce pesticide residues below the 

level of detection, reducing the exposure levels to the general U.S. population (CRA, 2000). In 

1998, the USDA evaluated pesticide residues in high-fructose corn syrup, milk, vegetables, and 

fruits (USDA-AMS, 1998). Corn syrup samples were collected from 40 states and analyzed for 

109 pesticides; no pesticide residues were detected in any of the corn syrup samples (USDAAMS, 1998).

Composition of Maize: Introduced Proteins

Human exposure to Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins has been reviewed by the 

USDA, the US-EPA and the US-FDA in the regulatory assessments, as cited in Subsection 4.1 –

Scope of the Environmental Analysis. These event traits have been commercially cultivated for 

many years in 1507, 59122, and 1507 x 59122 Maize.

As discussed in Subsections 1.3 – Coordinated Framework Review and Regulatory Review and 

2.5 Public Health, the US-EPA’s role in review of GE crops includes review of any introduced 

Cry proteins as PIPs under their FIFRA authority, and exemptions from tolerance for residues of 

pesticides on and in food and animal feed under its FFDCA authority. The Cry1F protein and its 

associated genetic elements had a determination of nonregulated status by USDA, was registered 

by the EPA, and was reviewed by the US-FDA in 2001 (US-FDA, 2001; USDA-APHIS, 2001; 

US-EPA, 2010f; Pioneer, 2011b). The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their 

associated genetic elements was reviewed by US-FDA in 2004, had a determination of 

nonregulated status by USDA in 2005, and was registered by US-EPA in 2005 (US-FDA, 2004; 

USDA-APHIS, 2005; US-EPA, 2010f; Pioneer, 2011b). Maize expressing the PAT protein has 

had a nonregulated status since 1995 and commercially cultivated in the United States since 1996 

(USDA-APHIS, 1995). The US-EPA has published exemptions from tolerance27 for these 

proteins (US-EPA, 2007a). There are no reports of human health effects associated with 

exposure to Bt or PAT proteins, or the 1507, 59122 or 1507 x 59122 Maize. 

27 As discussed in Subsection 1.3, the US-EPA, pursuant to its authority under the FFDCA, sets tolerances for the 

maximum residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement 

of tolerance, to reach a safety determination based on a finding of reasonable certainty of no harm from the potential 

exposure. To establish tolerance values, the US-EPA considers the toxicity of the pesticide and its breakdown 

products, the frequency of pesticide application and volume applied, and the amount of residue remaining in or on 

the food at the time it is marketed and prepared. Some pesticides are exempted from tolerance where the exemption 

is found to be safe. For additional details, see http://www.epa.gov/pesticides/factsheets/stprf.htm.

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The Cry1F, Cry34Ab1, and Cry35Abl proteins incorporated into 1507 and 59122 Maize were 

derived from Bt, a common bacterium, naturally occurring in soil, dust, insects, and leaves 

(McClintock et al., 1995; Schnepf et al., 1998; US-EPA, 1998). Bt is not a known human 

pathogen (US-EPA, 1998). Some strains of Bt have been shown to be opportunistic pathogens; 

however, this pathogenicity was not related to the Bt proteins (Hernandez et al., 1999). Bt

microbial preparations containing Cry proteins have been used safely as pesticide sprays for 

decades, and have been deemed to pose no toxic effects to mammals (US-EPA, 1998; USDA-FS, 

2004). These proteins have been present in commercial corn varieties such as 1507, 59122, 

and/or 1507 x 59122 Maize since 2003, 2006, and 2006, respectively (Pioneer, 2012). The 

incorporation of Bt proteins in corn has resulted in a decrease in the application of insecticides 

for the control of lepidopteran and coleopteran pests, an indirect benefit to human health

(Brookes and Barfoot, 2010).

The PAT protein incorporated into 1507 and 59122 Maize is derived from S. viridochromogenes, 

a common soil bacterium (Pioneer, 2012). The PAT protein has a safe history of exposure in 

humans, animals, and the environment. S. viridochromogenes is widespread in soil and is not 

associated with human, animal, or plant pathogens (Hérouet et al., 2005). Related PAT proteins 

are found in at least six other species of common soil bacteria, none of which have been reported

as toxic or allergenic to humans or animals (Hérouet et al., 2005). As noted in Subsection 2.2 –

Agricultural Production of Corn, the PAT protein has been present in commercial corn, as well 

as other crops, since 1996.

Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins have previously been reviewed for potential 

allergenicity and toxicity, and have been determined to have no amino acid sequence similar to 

known allergens, lacked toxic potential to mammals, and are degraded rapidly and completely in 

gastric fluid. (US-FDA, 2001; USDA-APHIS, 2001; US-FDA, 2004; USDA-APHIS, 2005; USEPA, 2010f; Pioneer, 2011b). Current human exposure to these Cry and PAT proteins has been 

determined to present no human health risk under the No Action Alternative.

Additionally, as discussed in Subsection 2.5 – Public Health, human food products manufactured 

from feed corn are subjected to a variety of mechanical and chemical processes to produce the 

final product, each step of which tends to disrupt protein integrity (Hammond and Jez, 2011). 

These processes suggest that human exposure to the Cry1F, Cry34Ab1, Cry35Ab1, and PAT 

proteins in corn will be limited under the No Action Alternative. 

Additionally, also noted in Subsection 2.5 – Public Health, the accumulation of the Cry proteins 

in GE corn plants provides an additional indirect benefit to human health, in that the control of 

certain insect pests of corn results in a lower incidence of fungal infection and mycotoxin 

formation (Munkvold and Hellmich, 1999; Munkvold and Hellmich, 2000; Vincelli and Parker, 

2002; US-EPA, 2010b; US-EPA, 2010a). These benefits already accrue from the widespread 

adoption of corn varieties containing these Cry proteins, including 1507 and 59122 Maize which 

are already in the market.

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4.5.1.2 Preferred Alternative: Human Health 

Under the Preferred Alternative, potential impacts to human health are not anticipated to be 

substantially different than under the No Action Alternative. As discussed in Subsection 4.1 –

Scope of the Environmental Analysis, Pioneer 4114 Maize contains the same genetic elements as 

1507, 59122, and 1507 x 59122 Maize; accordingly, Pioneer 4114 Maize is phenotypically 

identical to 1507 x 59122 Maize (see, e.g., (De Schrijver et al., 2007)).

The human health effects of the cultivation of the Pioneer 4114 Maize are expected to be 

identical to those already evaluated and described for 1507, 59122, and 1507 x 59122 Maize. 

Public health concerns surrounding GE crops, like Pioneer 4114 Maize, are generally related to 

consumption of the GE crop itself. Pioneer 4114 Maize contains the Cry1F, Cry34Ab1, 

Cry35Ab1, and PAT proteins. Pioneer 4114 Maize also is likely to be sprayed with glufosinate if 

it is commercialized following a determination of nonregulated status. It is expected that 

glufosinate use on the Pioneer 4114 Maize would be consistent with the US-EPA-approved label. 

Glufosinate Use and Exposure

As discussed in the No Action Alternative, glufosinate is already used in U.S. corn production, 

meaning that the general population may already be exposed to glufosinate or its residues on 

corn grain.

A determination of nonregulated status of Pioneer 4114 Maize is not likely to change the 

herbicide use patterns for glufosinate in U.S. corn production. There are no proposed label 

changes for glufosinate use associated with the cultivation of Pioneer 4114 Maize (Pioneer, 

2011b).The per acre volume of glufosinate will not increase over currently approved label rates 

(Pioneer, 2011b). As discussed in Subsection 4.2.2 – Agronomic Practices, a grower adopting 

Pioneer 4114 Maize varieties would potentially substitute Pioneer 4114 for 1507 x 59122 Maize. 

Moreover, growers are highly likely to substitute glufosinate for other herbicides (Towery and 

Werblow, 2010). The US-EPA has determined that glufosinate does not present a human health 

impact when applied in accordance with label restrictions (US-EPA, 2003). As there are no 

changes in application rates or total applications for Pioneer 4114 Maize, pesticide residue 

tolerances are not expected to change. 

Accordingly, a determination of nonregulated status for Pioneer 4114 Maize is not expected to

substantially impact human health with respect glufosinate or its residues on corn grain, relative 

to the No Action Alternative. 

Composition of Pioneer 4114 Maize: Expressed Proteins

The traits expressed in Pioneer 4114 Maize have been commercially cultivated for many years. 

The introduced Cry and PAT proteins in Pioneer 4114 Maize are identical to the Cry and PAT 

proteins previously reviewed by the US-EPA, US-FDA, and USDA for 1507, 59122 and 1507 x 

59122 Maize varieties that are currently cultivated and presented in the No Action analysis.

The Cry1F protein and its associated genetic elements are identical to those in 1507 Maize; the 

binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements are 

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identical to those in 59122 Maize; maize expressing the PAT protein has had a nonregulated 

status since 1995 and commercially cultivated in the United States since 1996 (USDA-APHIS, 

1995). Pioneer has compared Pioneer 4114 with the foundation varieties, and has found no 

biologically meaningful differences in the accumulation of these proteins or composition of the 

corn plants (Pioneer, 2011b; USDA-APHIS, 2012e). Consequently, the health impacts of Pioneer 

4114 Maize is unlikely to be substantially different than the health impacts of 1507, 59122, or 

1507 x 59122 Maize varieties described in the No Action Alternative.

Pioneer conducted safety evaluations based on Codex Alimentarius Commission procedures to 

assess any potential adverse effects to humans or animals resulting from environmental releases 

and consumption of Pioneer 4114 Maize (FAO, 2009; Pioneer, 2011b; US-FDA, 2011). These 

safety studies included evaluating protein structure and function, including homology searches of 

the amino acid sequences with comparison to all known allergens and toxins (Pioneer, 2011b). 

The Cry and PAT proteins expressed in Pioneer 4114 Maize have previously been reviewed for 

potential allergenicity and toxicity, and have been determined to have no amino acid sequence 

similar to known allergens, lacked toxic potential to mammals, and are degraded rapidly and 

completely in gastric fluid (Pioneer, 2011b). 

Pioneer has compared the compositional characteristics of Pioneer 4114 Maize with the near 

isoline and reference maize hybrids (Pioneer, 2011b). Composition characteristics evaluated in 

these comparative tests include moisture, protein, fat, carbohydrates, ash, minerals, dietary fiber, 

essential and non-essential amino acids, fatty acids, vitamins, and anti-nutrients (OECD, 2002; 

Pioneer, 2011b). A comprehensive comparison of Pioneer 4114 Maize with the near isoline 

variety showed no biologically meaningful differences for composition (Pioneer, 2011b; USDAAPHIS, 2012e). 

Pioneer submitted a Voluntary Consultation to the US-FDA for this product on 22 December 

2011. FDA completed its evaluation on March 25, 2013. As noted above, Pioneer 4114 Maize

proteins have been present in commercial corn varieties such as 1507, 59122, and 1507 x 59122 

Maize since 2003, 2006, and 2006, respectively (Pioneer, 2012). There are no reports of adverse 

effects to human health from the consumption of these corn varieties. Corn varieties based on 

these three lines are already in the commercial market. Additionally, the proteins in Pioneer 4114 

Maize are rapidly degraded by gastric fluids, further limiting human exposure to the proteins 

expressed by this corn variety. 

Based on these factors, including an analysis of field and laboratory data related to Pioneer 4114 

Maize (Pioneer, 2011b), safety data available on other GE corn varieties, and the identical

phenotypes of Pioneer 4114 Maize to the currently-cultivated 1507 x 59122 maize, USDAAPHIS has concluded that a determination of nonregulated status of Pioneer 4114 Maize is 

unlikely to present an adverse impact on human health. Overall impacts on human health are 

similar to those expected for the No Action Alternative. 

4.5.2 Worker Safety

EPA’s WPS (40 CFR Part 170) was published in 1992 to require actions to reduce the risk of 

pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS 

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contains requirements for pesticide safety training, notification of pesticide applications, use of 

personal protective equipment, restricted entry intervals following pesticide application, 

decontamination supplies, and emergency medical assistance. 

4.5.2.1 No Action: Worker Safety 

During agricultural production of corn, agricultural workers and pesticide applicators may be 

exposed to a variety of US-EPA-registered pesticides. Under the No Action Alternative, 

agricultural workers and pesticide applicators may be exposed to the herbicide glufosinate which 

is labeled for use on corn. The 2003 US-EPA registration for glufosinate evaluated occupational 

exposures, including short-term inhalation and dermal exposure estimates (US-EPA, 2003; USEPA, 2008a). In this review, the US-EPA concluded that occupational exposures were below the

US-EPA’s level of concern (US-EPA, 2003; US-EPA, 2008a).

Maize varieties based on 1507, 59122, and 1507 x 59122 Maize are anticipated to still be 

cultivated. As noted previously in Subsection 4.2.2 – Agronomic Practices, in 2010, 

approximately 16% of the commercial corn acreage was planted with a 1507 x 59122 Maize

(Pioneer, 2011b). With regard to glufosinate use on corn, in 2010, approximately 2% of the total 

corn acreage was treated with glufosinate (USDA-NASS, 2011a). Agricultural workers would 

continue to be exposed to glufosinate and its residues on those corn acres treated with that 

herbicide.

As discussed in Subsection 4.5.1 – Human Health, US-EPA’s pesticide registration labels 

establish use restrictions for the pesticide. Growers are required to use pesticides such as 

glufosinate ammonium consistent with the application instructions provided on the US-EPAapproved pesticide label (Bayer, 2012). These label restrictions carry the weight of law and are 

enforced by US-EPA and the states (FIFRA 7 USC 136j (a)(2)(G) Unlawful Acts).

The current label for glufosinate includes guidance and label use restrictions intended to protect 

agricultural workers, including protective equipment to be worn during mixing, loading, 

applications and handling, equipment specifications to control pesticide application, and reentry 

periods establishing a safe duration between pesticide application and exposure to the pesticide 

in the field (Bayer, 2012). Used in accordance with the label, glufosinate has been determined to 

not present a health risk to humans (US-EPA, 2008b). Appendix B provides a copy of a sample 

glufosinate label.

As discussed in Agricultural Production of Corn (Subsections 2.2 and 4.2), in 2010, 16% of the 

corn acreage was cultivated in 1507, 59122, or 1507 x 59122 Maize (Pioneer, 2011b). Growers 

cultivating these varieties are already exposed to glufosinate and the Cry and PAT proteins. In 

2010, corn growers applied glufosinate to 2% of the total acreage of corn cultivated (USDANASS, 2011a).

4.5.2.2 Preferred Alternative: Worker Safety

Under the Preferred Alternative, no substantial impacts to worker safety are anticipated 

compared to the No Action Alternative. Glufosinate is currently registered for use on corn (see, 

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e.g., Bayer, 2012), including 1507, 59122, and 1507 x 59122 Maize. Similar to the No Action 

Alternative, it is expected that US-EPA registered pesticides that currently are used for corn 

production will continue to be used by growers, including the use of glufosinate. Pioneer 4114 

Maize is not expected to change the application rates of glufosinate on corn, and a label change 

is not required (Pioneer, 2011b). Worker exposure to glufosinate under the Preferred Alternative 

is not expected to be substantially different than that already experienced under the No Action 

Alternative, as Pioneer 4114 Maize is anticipated to be cultivated in lieu of 1507 x 59122 Maize

in the United States. 

Based on the above information, the potential impacts to worker safety from a determination of 

nonregulated status of Pioneer 4114 Maize under the Preferred Alternative are the same as those 

under the No Action Alternative. 

4.6 ANIMAL FEED

Corn comprises approximately 95% of the total feed grain produced and used in the United 

States (USDA-ERS, 2011d). Animal feed derived from corn comes not only from the 

unprocessed grain, but also from the residuals derived from three major corn industries: corn 

refining, corn dry millers, and distillers (CRA, 2006). Animal feed products from corn refining 

and wet milling include corn gluten feed, corn gluten meal, corn germ meal, corn steep liquor, 

and amino acids (CRA, 2006). 

As with human health, animal consumption of GE is a concern expressed by some individuals. 

This includes consumption of GE corn material as feed and the consumption of any herbicide or 

herbicide residues that may remain on the plant material after processing for animal feed. 

4.6.1 No Action: Animal Feed

Under the No Action Alternative, Pioneer 4114 Maize will remain a regulated product and will 

not be available as an animal feed. However, corn-based animal feed will still be available from 

currently cultivated corn crops, such as 1507, 59122, and 1507 x 59122 Maize. Consequently, 

the Cry and PAT proteins contained within 1507, 59122, and 1507 x 59122 Maize will continue 

to be present in U.S. corn production and thus be present in animal feed. This includes Cry1F 

(1507 Maize), Cry 34Ab1 and Cry35Ab1 (59122 Maize), and any hybrid containing the 1507 x 

59122 cross. This means that under the No Action Alternative, the introduced proteins in Pioneer 

4114 Maize may continue to be present in animal feed in the United States through the continued 

cultivation of 1507, 59122, and 1507 x 59122 Maize.

As discussed in Subsection 4.5 – Public Health, the US-EPA and the US-FDA have already 

reviewed the animal feed safety of the introduced proteins in 1507, 59122, and 1507 x 59122 

Maize. These Cry and PAT proteins have previously been reviewed for potential allergenicity 

and toxicity, and have been determined to have no amino acid sequence similar to known 

allergens, lacked toxic potential to mammals, and are degraded rapidly and completely in gastric 

fluid (US-FDA, 2001; USDA-APHIS, 2001; US-FDA, 2004; USDA-APHIS, 2005; US-EPA, 

2010f; Pioneer, 2011b). Under the No Action Alternative, current exposure to these Cry and 

PAT proteins has been determined to present no animal feed risk. Additionally, as discussed in 

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Subsection 4.5.1.1 – Human Health, tolerances have been published for glufosinate and the 

introduced proteins in 1507, 59122, and 1507 x 59122 Maize (US-EPA, 2007a; US-EPA, 

2010d). 

Under the No Action Alternative, animals may continue to be exposed to 1507, 59122, and 1507 

x 59122 Maize and Cry1F, Cry34Ab1, Cry 35Ab1, PAT, and glufosinate through animal feed in 

the United States. 

4.6.2 Preferred Alternative: Animal Feed

Under the Preferred Alternative, it is unlikely that a determination of nonregulated status of 

Pioneer 4114 Maize will result in substantial impacts to animal feed compared to the No Action 

Alternative. The results of studies conducted by Pioneer confirm that there are no differences in 

feed safety between the Pioneer 4114 Maize and other varieties currently available under the No 

Action Alternative (Pioneer, 2011b). As discussed in the analysis of the No Action Alternative, 

animal feed likely already contains the introduced proteins in Pioneer 4114 Maize and 

glufosinate or glufosinate residues. The Preferred Alternative is unlikely to be different in this 

regard (see, e.g., (De Schrijver et al., 2007)). 

As noted in Subsection 1.3 – Coordinated Framework Review and Regulatory Review, Pioneer 

has made a voluntary submittal to the US-FDA for this product. The US-FDA completed its 

review on March 25, 2013.

USDA-APHIS’ assessment of the potential impacts of the consumption of the Cry1F, Cry34Ab1, 

Cry35Ab1, and PAT proteins by animals through animal feed considers the source of the gene 

and the expressed protein, exposure to pesticide residuals, and safety evaluations conducted by 

Pioneer. Our analysis is similar to that presented above in Subsection 4.5 – Public Health. 

As described in Subsection 4.5 – Public Health, Pioneer has evaluated the allergenicity and 

toxicity of Pioneer 4114 Maize, and has compared this variety with a conventional corn isoline to 

assess composition. Compositional elements compared included protein, fat, acid detergent fiber, 

neutral detergent fiber, carbohydrates, ash, fatty acids, amino acids, vitamins and minerals, key 

anti-nutrients, and key secondary metabolites (Pioneer, 2011b). In these studies, compositional 

comparisons were made between Pioneer 4114 Maize and a near isoline control grain (Pioneer, 

2011b). There were no biologically meaningful differences for any of these compositional 

characteristics between the Pioneer 4114 Maize and conventional corn varieties, including 1507, 

59122, and 1507 x 59122 Maize (Pioneer, 2011b). Animals are already exposed to glufosinate 

and glufosinate residues in animal feed, particularly animal feed derived from 1507, 59122, and 

1507 x 59122 Maize, as described in the No Action Alternative. Pioneer is not proposing a 

change in label application rates for Pioneer 4114 Maize; glufosinate will be applied in the same 

rates as those discussed in the No Action Alternative. Accordingly, the tolerance exemptions for 

glufosinate for animal feed uses will not change, and are no different than those under the No 

Action Alternative. 

Based on the analysis of field and laboratory data and scientific literature provided by Pioneer 

(Pioneer, 2011b; Pioneer, 2012), safety data available on other GE corn (e.g.,1507, 59122 and 

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DRAFT PIONEER 4114 MAIZE

1507 x 59122 Maize), and the already-extant exposure of animals to Cry1F, Cry34Ab1, 

Cry35Ab1, and PAT proteins through animal feed, USDA-APHIS has concluded that a 

determination of nonregulated status of Pioneer 4114 Maize is unlikely to have an adverse 

impact on animal health with regard to animal feed. Overall impacts are similar to those of the 

No Action Alternative. 

4.7 SOCIOECONOMIC 

4.7.1 Domestic Economic Environment 

Domestic economic impacts associated with adoption of a new GE trait are focused on the 

impact of that trait on the agronomic inputs and associated on-farm costs, as well as the potential 

market impacts.

As noted in Subsection 2.2 – Agricultural Production of Corn, insect-resistant corn and 

herbicide-resistant varieties incorporating insect resistance are already widely cultivated in the 

United States. Additionally, as discussed in Subsection 2.7.1 – Domestic Economic 

Environment, the cultivation of insect-resistant Bt corn provides several collateral economic 

benefits. The incorporation of Bt proteins in corn has resulted in a decrease in the application of 

insecticides for the control of lepidopteran and coleopteran pests. Growers adopting this 

technology would benefit from the reduction in costs associated with the purchase, handling, 

application and disposal of these insecticides.

An additional economic benefit is the reduction in mycotoxin contamination that is a secondary 

impact from insect injury to corn kernels (Munkvold and Hellmich, 1999; Munkvold and 

Hellmich, 2000). Bt corn is less prone to insect injury, which, in turn, prevents the growth of 

fungi that produce mycotoxins (Munkvold and Hellmich, 1999; Munkvold and Hellmich, 2000; 

Vincelli and Parker, 2002; US-EPA, 2010b; US-EPA, 2010a). Reductions in fumonisin 

mycotoxins have a positive economic benefit to the growers as corn grain that contains 

mycotoxins above a certain level is more likely to be rejected in the market, forcing growers to 

accept the lower price for non-food uses (US-EPA, 2010b). 

4.7.1.1 No Action: Domestic Economic Environment

Under the No Action Alternative, Pioneer 4114 Maize will continue to be a regulated article 

under the regulations at 7 CFR Part 340. Growers and other parties who are involved in 

production, handling, processing, or consumption of corn will not have access to Pioneer 4114 

Maize, but will continue to have access to currently-available conventional and GE corn varieties

(Hyten, personal communication, 2013). As noted in Subsection 4.1- Scope of the Environmental 

Analysis, this includes GE corn varieties that are no longer subject to the regulations are 7 CFR 

Part 340 and the plant pest provisions of the Plant Protection Act of 2000, such as 1507, 59122, 

and 1507 x 59122 Maize. 

Growers currently select corn varieties based on a wide range of considerations, including 

market conditions and end use requirements. For example, as discussed in Subsection 2.7.1 –

Domestic Economic Environment, the current market for ethanol has influenced some growers to 

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DRAFT PIONEER 4114 MAIZE

convert soybean or cotton acreage to corn, as well as convert from livestock feed corn varieties 

to corn varieties providing better ethanol production feedstock (USDA-ERS, 2012e; USDAOCE, 2012b). The result of these corn cultivation trends includes changes in crop acreage 

dedicated to corn, shifts of corn varieties cultivated, and current commodity grain pricing. These 

trends are unaffected by the No Action Alternative. 

Growers adopting GE corn varieties incur a cost premium to acquire the seed (NRC, 2010).

These technology fees are imposed by the product developer to cover their research and 

development costs, resulting in GE seeds that are traditionally more expensive than conventional 

seed (NRC, 2010). Growers cultivating GE crops all pay such technology fees. The NRC 

suggests that the benefits associated with the adoption of GE crops, including a reduction in 

agronomic inputs and increases in yield outweigh the extra costs of the GE seed (NRC, 2010). 

The continued emergence of glyphosate-resistant weed biotypes has been identified as an 

economic concern (NRC, 2010). Glyphosate-resistant weed biotypes have been demonstrated to 

reduce the effectiveness and economic benefits of glyphosate-resistant crop systems (Owen et 

al., 2011a; Weirich et al., 2011). Current research advocates using herbicides presenting multiple

modes of action to manage these weeds (see, e.g., Owen et al., 2011a). Growers would select 

other herbicides based on the targeted weed and herbicide resistance traits of the targeted weed 

(Purdue, 2012). Glufosinate is one such herbicide offering another mode of action to control 

glyphosate-resistant weeds. As previously noted in Subsection 2.2 – Agricultural Production in 

Corn, in 2010, 16% of the commercial corn acreage was cultivated in 1507, 59122, or the 1507 x 

59122 hybrid, each of which is resistant to glufosinate (Pioneer, 2012).

To manage herbicide-resistant weeds, growers have increased herbicide application rates, 

increased the number of herbicide applications, and have returned to more traditional tillage 

practices (Sandell et al., 2009; NRC, 2010). The economic impacts of glyphosate-resistant weeds 

are a direct result of increased inputs: additional herbicides are required to control the weeds; 

fuel costs increase as heavy equipment is used more frequently in the field for chemical 

application; and tillage and labor and management hours increase in association with the 

application of additional herbicides and machinery use (NRC, 2010; Weirich et al., 2011). There 

is an additional cost from the reduction in yield associated with the competition of the crop with 

the weeds (NRC, 2010; Weirich et al., 2011; Wilson, 2011).

Under the No Action Alternative, growers will continue to benefit from the adoption and 

cultivation of GE crops, including the commensurate reduction in costs associated with 

insecticide applications (Duke and Powles, 2009b). At the same time, those growers managing 

herbicide-resistant weeds may incur increased costs to employ a wide range of management 

techniques, including increased pesticide use and increased tillage. These trends are unaffected 

by the No Action Alternative.

4.7.1.2 Preferred Alternative: Domestic Economic Environment

Under the Preferred Alternative, trends related to the domestic economic environment are 

unlikely to be different than what is currently occurring in the No Action Alternative (Subsection 

4.7.1.1).

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DRAFT PIONEER 4114 MAIZE

Pioneer presented results of field trials comparing the performance and composition of Pioneer 

4114 Maize with other GE and non-GE corn varieties when cultivated under different agronomic 

conditions and using a range of agronomic inputs (Pioneer, 2012; USDA-APHIS, 2012e). No 

biologically meaningful differences were observed regarding agronomic characteristics between 

Pioneer 4114 Maize and any of the other varieties (Pioneer, 2012). As noted in Subsection 4.1 –

Scope of the Environmental Analysis, Pioneer 4114 Maize is phenotypically identical to 1507 x 

59122 Maize, meaning that it contains identical genetic elements (Cry1F, Cry34Ab1, Cry35Ab1, 

and PAT), identical traits, and similar agronomic performance. Based on the identical 

phenotypes and the likelihood that Pioneer 4114 Maize will replace some of the acreage planted 

to 1507 x 59122 Maize, a determination of nonregulated status of Pioneer 4114 Maize is not 

anticipated to change the area or acreage of U.S. corn production (Subsection 4.2.1) or

Agronomic Practices (Subsection 4.2.2) associated with corn production, Additionally, as noted 

in Subsection 2.7.1 – Domestic Economic Environment and Subsection 4.7.1.1 – No Action, the 

selection and cultivation of corn varieties, and the decision to cultivate corn (rather than 

soybeans or cotton, for example), is based on the market for the crop, and not the specific 

availability of a particular GE variety. Based on these data, the potential domestic economic 

impacts associated with the cultivation of Pioneer 4114 Maize are no different than those 

currently observed for other corn varieties under the No Action Alternative. 

4.7.2 Trade Economic Environment 

Potential impacts to the trade economic environment from a determination of nonregulated status 

of a new GE trait relates to the potential of that trait to impact trade of corn commodities 

between the United States and other countries.

4.7.2.1 No Action: Trade Economic Environment 

The cropping and marketing decisions made by corn growers are unlikely to be influenced by the 

selection of this alternative. The acreage planted in GE corn has increased over time, and it is 

expected that the corn produced will continue to be planted with the currently available GE corn. 

In 2012, 88% of the corn cultivated in the United States was GE (USDA-NASS, 2012b). U.S. 

corn will continue to play a role in global corn market, based on existing trends of corn 

production. The United States is the largest exporter of corn in the world market, although the

anticipated export in 2012 will be reduced substantially as a result of the extreme heat and 

dryness in the Corn Belt (USDA-OCE, 2012d; USDA-OCE, 2012c). In 2010/2011, the United 

States exported approximately 46.59 million metric tons of corn, against a global export market 

of 91.46 million metric tons (USDA-OCE, 2012c). Projections for the export market in 

2011/2012 show an estimated United States export of 39.19 million metric tons, against a global 

export market of 108.11 million metric tons (USDA-OCE, 2012c). How and where the corn and 

corn products will be used will be subject to global market conditions. In 2012, over 25 countries 

were identified to import corn (USDA-FAS, 2012). These conditions are not expected to change 

under the No Action Alternative. 

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DRAFT PIONEER 4114 MAIZE

4.7.2.2 Preferred Alternative: Trade Economic Environment 

A determination of nonregulated status of Pioneer 4114 Maize is not expected to adversely 

impact the trade economic environment. Products containing 4114 Maize will have the same 

global uses as products containing 1507 x 59122 Maize, once appropriate regulatory 

authorizations are obtained in key export countries for the Pioneer 4114 Maize (Pioneer, 2012).

Pioneer plans to submit applications to several international agencies, including the regulatory 

authorities in Canada, China, Japan, Mexico, South Korea and Taiwan (Pioneer, 2011b). These

regulatory authorities include United States trade partners for import clearance and production 

approval (USDA-FAS, 2012). As of the time of the preparation of this EA, conclusions of the 

other international agencies had not been published. However, Pioneer will only initiate a 

commercial launch of the product after obtaining all necessary authorizations in both the United 

States and key import countries with functioning regulatory processes (Pioneer, 2011b).

Based on these factors, the trade economic impacts associated with the determination of 

nonregulated status of Pioneer 4114 Maize are anticipated to be similar to the No Action 

Alternative. 

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DRAFT PIONEER 4114 MAIZE

5 CUMULATIVE IMPACTS

5.1 ASSUMPTIONS USED FOR THE CUMULATIVE IMPACTS ANALYSIS

Potential cumulative impacts regarding specific issues are analyzed and addressed within this 

section. The principal issue associated with the analysis of cumulative impacts pertains to 

Pioneer’s intention to limit the cultivation of Pioneer 4114 Maize as a foundation stock for 

developing stacked hybrids28 through conventional breeding techniques (Pioneer, 2011b). 

In this hybridization process, the traits in Pioneer 4114 Maize would be combined with the traits 

from other corn crop varieties that are no longer subject to the regulatory requirements of 7 CFR 

Part 340 or the plant pest provisions of the Plant Protection Act of 2000. USDA-APHIS does not 

have jurisdiction under the Plant Protection Act of 2000 and Part 340 to review such stacked 

hybrids developed using nonregulated articles and conventional hybridization techniques where 

there is no evidence of a plant pest risk. Accordingly, the body of this EA focuses on the 

cultivation of Pioneer 4114 Maize. This cumulative impacts analysis focuses on the incremental 

impacts of the Preferred Alternative taken in consideration with related activities, including past, 

present, and reasonably foreseeable future actions, with a focus on the implications of future 

stacking or pyramiding of this product with glyphosate resistance. USDA-APHIS’ rationale for 

limiting this review to a stacked product resulting in a hybrid combining the traits of Pioneer 

4114 Maize with glyphosate resistance is provided below.

It is important to reiterate that the four introduced proteins in Pioneer 4114 Maize, Cry1F, 

Cry34Ab1, Cry35Ab1, and PAT, are unique only insofar as they are integrated at a single locus29

in the genome. The individual elements of Pioneer 4114 Maize have been commercially 

available for over a decade as 1507 and 59122 Maize, and more recently, hybrid stacks in which 

the two are combined as 1507 x 59122 Maize. Stacked products based off of the Pioneer 4114 

Maize are not necessarily complete replacement products for 1507, 59122 or 1507 x 59122 

hybrid varieties; some growers may only have a need for the 1507 product, for example, to 

control European Corn Borer (Pioneer, 2011b; Pioneer, 2012). In 2010, commercial products 

containing the 1507 x 59122 Maize were grown on approximately 14 million acres, or 16% of 

U.S. maize acres (GfK Kynetec, 2010; Pioneer, 2011b). Table 4-1 presents those US-EPA

registrations for commercial corn products containing 1507, 59122, or 1507 x 59122 Maize 

events. 

28 As previously defined in Subsection 1.2, stacked products contain two or more genes targeting multiple pests; 

whereas pyramided products contain two or more genes targeting a single species.

29 As previously defined in Subsection 1.2, an insertion at a single locus in the genome means that all introduced 

genetic elements are integrated at a single point. This is in contrast to conventional breeding stacks where the 

introduced genetic elements are located in more than one point in the genome. For example, in 1507 x 59122 Maize, 

the gene encoding Cry1F is located in one location in the genome; whereas the gene encoding Cry34Ab1/Cry35Ab1 

is located in another location in the genome

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DRAFT PIONEER 4114 MAIZE

To narrow the issue, and provide a basis for a meaningful evaluation, this cumulative impact 

analysis is undertaken with the assumption that Pioneer 4114 Maize will be stacked with a GE 

corn variety exhibiting glyphosate resistance. This stack was selected for analysis in this 

Cumulative Impacts section because Pioneer has expressly stated that a conventionally produced 

hybrid stacking Pioneer 4114 Maize with a glyphosate-resistant corn variety is reasonably 

expected and highly likely to be the first product developed using the Pioneer 4114 Maize as the 

foundation variety (Pioneer, 2011b; Pioneer, 2012). Note that the current environmental 

conditions and associated impacts associated with the cultivation of 1507, 59122, 1507 x 59122 

hybrid varieties and Pioneer 4114 Maize have been presented previously in Subsections 2.1-2.3 

and 4.1-4.3. Pioneer 4114 Maize includes three different Cry proteins, Cry1F and 

Cry34Ab1/Cry35Ab1 that provide robust insect resistance to both coleopteran and lepidopteran 

insect pests. 

Additional insect- resistant traits could be added to 4114 stacks, including Bt11, MON810,

MON88017, MON89034, MIR162, MIR604, and 5307, all of which are no longer regulated. 

The genes and target pests for these Bt events are shown in Table 5-1, below. 

Table 5-1. Bt insect resistant traits currently on the U.S. market.

Bt Event Gene Controls

Bt11 Cry1Ab European corn borer (Ostrinia

nubilalis)

MON810 Cry1A(b) European corn borer (Ostrinia

nubilalis)

MON88017 Cry3Bb1 Corn rootworm species 

(Diabrotica species)

MON89034 Cry1A.105, Cry2Ab2 European corn borer (Ostrinia 

nubilalis), Asian corn borer 

(Ostrinia furnacalis), 

southwestern corn borer 

(Diatraea grandiosella), 

sugarcane borer (Diatraea 

saccharalis, fall armyworm 

(Spodoptera frugiperda), corn 

earworm (Helicoverpa zea)

Corn rootworm species 

(Diabrotica species)

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DRAFT PIONEER 4114 MAIZE

MIR162 Vip3Aa20 Black cutworm (Agrotis 

ipsilon), corn earworm 

(Helicoverpa zea), fall 

armyworm (Spodoptera 

frugiperda), western bean 

cutworm (Striacosta 

albicosta)

MIR604 mCry3A Corn rootworm species 

(Diabrotica species)

5307 eCry3.1Ab Corn rootworm species 

(Diabrotica species)

Sources: USDA-APHIS

The hybrid stack considered in this cumulative impacts analysis considers the combination of the 

glufosinate resistance and insect resistance from Pioneer 4114 Maize combined, using 

conventional breeding techniques, with glyphosate resistance from a GE corn variety no longer 

subject to the regulatory requirements at 7 CFR Part 340 or the plant pest provisions of the Plant 

Protection Act of 2000. Corn varieties presenting resistance to both glufosinate and glyphosate 

are already in the market (see, e.g., Darby, 2007; Neilsen, 2010; Wilson et al., 2010). Recent 

commercial hybrids presenting this stack include the following products:

• DAS/Pioneer Hi-Bred Herculex 1 Monsanto Roundup Ready® Corn, which combined 

1507 with NK603;

• Syngenta Agrisure GT/CB/LL, which combined SYGGA21 and Bt11;

• DAS Pioneer Hi-Bred Herculex RW Monsanto Roundup Ready® Corn 2, which 

combined 59122 and NK603; 

• DAS Pioneer Hi-Bred Herculex Xtra Monsanto Roundup Ready® Corn 2, which 

combined 1507 x 59122 and NK603; and 

• Monsanto Genuity® SmartStax®, which combined Mon88017 x Mon89034 x 1507 x 

59122 (Neilsen, 2010).

Glyphosate is not an approved tank mix partner with glufosinate (see, e.g., Bayer, 2012). When 

growers adopt a stacked hybrid and elect to use both herbicides, the herbicides are applied 

sequentially, in accordance with label instructions, as part of the grower’s weed management 

strategies (see, e.g., Monsanto, 2009).

The potential impacts from the cultivation of glyphosate-resistant crops, with a corresponding 

analysis of the implications of the use of glyphosate, have been thoroughly evaluated in other

USDA-APHIS EAs and EISs (notably the recent EISs for glyphosate-resistant Sugar Beet and 

glyphosate-resistant alfalfa) prepared to support determination of nonregulated status decisions, 

beginning in 1993 with the introduction of the first glyphosate-resistant crop product. 

(See: www.APHIS.USDA.gov/biotechnology/not_reg.htm.) Several of these evaluations 

included crops expressing resistance to multiple herbicides. Specific crop examples include:

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DRAFT PIONEER 4114 MAIZE

• Sugar Beet, 2011. Monsanto and KWS SAAT AG Glyphosate-resistant Sugar Beet 

(Petition No. 03-323-01p). 

• Soybean, 2011. Monsanto Improved Fatty Acid Profile Soybean (which includes 

glyphosate resistance) (Petition No. 09-201-01p). 

• Alfalfa, 2011. Monsanto Glyphosate-resistant Alfalfa (Petition 04-110-01p). 

• Corn, 2009. Pioneer Glyphosate and Imadazolinone-resistant Corn (Petition 07-152-01p).

• Cotton, 2009. Bayer Crop Science Glyphosate-resistant Cotton (Petition 06-332-01p).

• Soybean, 2008. Pioneer Glyphosate and Acetolactate Synthase-resistant Soybean 

(Petition No. 06-271-01p).

• Soybean, 2007. Monsanto Glyphosate-resistant Soybean (Petition 06-178-01p).

• Cotton, 2005. Monsanto Glyphosate-resistant Cotton (Petition 04-086-01p).

• Rapeseed 2001. Monsanto Glyphosate-resistant Rapeseed (Petition 01-324-01p).

• Corn, 2000. Monsanto Glyphosate-resistant Corn (Petitions No. 97-099-01p and 00-011-

01p).

• Rapeseed 1998. Monsanto Glyphosate-resistant Rapeseed (Petition 98-216-01p).

• Sugar Beet, 1998. Novartis Seeds and Monsanto Glyphosate-resistant Sugar Beet 

(Petition No. 98-173-01p). 

• Corn, 1997. Monsanto Glyphosate-resistant Corn. (Petition No. 97-099-01p).

• Corn, 1996. Monsanto Glyphosate-resistant and European Corn Borer-resistant Corn. 

(Petition No. 96-317-01p).

• Cotton, 1995. Monsanto Glyphosate-resistant Cotton (Petition 95-045-01p).

• Soybean, 1993. Monsanto Glyphosate-resistant Soybean (petition 93-258-01p).

Glyphosate-resistant (e.g., Roundup Ready®) corn varieties no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 

have been in the market since 1996 (USDA-APHIS, 2012b). The majority of corn cultivated in 

the U.S. is herbicide-resistant, most of which is glyphosate-resistant (Duke and Powles, 

2009a; USDA-ERS, 2011b). As evidenced by the above list of glyphosate-resistant crops, the 

application and use of glyphosate on Roundup Ready® crops has been well-described. 

Glyphosate is already used in corn in both conventional and Roundup Ready® varieties.

Future combinations of 4114 with one or more of the deregulated insect-resistant traits in Table

5-1 could be developed and sold. An analysis of the cumulative impacts of such potential 

stacking configurations is considered in the individual sections below.

5.2 CUMULATIVE IMPACTS: AREAS AND ACREAGE OF CORN PRODUCTION

As discussed in Subsection 4.2.1 –Areas and Acreage of Corn Production, the traits that are the 

foundation for Pioneer 4114 Maize are already in widespread cultivation, and there are no 

characteristics of Pioneer 4114 Maize that would be expected to change the areas or range of 

corn cultivated. Neither the No Action Alternative nor the Preferred Alternative are expected to 

directly cause an increase in agricultural acreage devoted to corn production or those corn acres 

devoted to GE corn cultivation. The availability of Pioneer 4114 Maize as a breeding stock to 

create hybrid stacks would not change cultivation areas for corn production in the United States 

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DRAFT PIONEER 4114 MAIZE

and there are no anticipated changes to the availability of GE and non-GE corn varieties on the 

market under either alternative. 

Stacking Pioneer 4114 Maize with glyphosate-resistant maize is not expected to influence areas 

and acreage of crop production. Glyphosate-resistant corn has been commercially available since 

1996 (see http://www.aphis.usda.gov/biotechnology/not_reg.html). Glyphosate would likely 

continue to be a major component of weed management in corn production because of its 

flexibility in application, its efficacy against a broad spectrum of weeds, and its relatively low 

cost (Powles, 2008; Duke and Powles, 2009a; Green and Owen, 2011; Owen et al., 2011b). The 

glyphosate-resistant varieties are already widely cultivated, based on the percentage of corn 

currently treated with glyphosate (noted in Subsection 2.2 – Agronomic Inputs as 66% of the 

acreage, ~57 million pounds) (USDA-NASS, 2011b; USDA-NASS, 2011a). Any stack between 

Pioneer 4114 Maize and a GE glyphosate-resistant corn variety would also not be expected to 

increase the area or range of corn cultivation in the United States. The individual GE corn 

parents of this stack would have been previously reviewed and found to not likely extend the 

area of range of U.S. corn cultivation (USDA-APHIS, 2012e), strongly suggesting that any 

offspring from Pioneer 4114 and glyphosate-resistant corn would not extend area or range of 

corn cultivation in the United States. Additionally, as noted above in Subsection 5.1 –

Assumptions Used for the Cumulative Impacts Analysis, multiple commercial varieties stacking 

glufosinate and glyphosate resistance are already in the market and are being commercially 

cultivated. Moreover, as discussed in Subsection 4.2 – Agricultural Production of Corn, the 

cultivation of a GE variety is not the determinative factor in a grower’s selection of corn.

Growers select corn over soybean or cotton, for example, on the basis of market demand 

(USDA-ERS, 2011e). Consequently, a stacked product offering resistance to glufosinate and 

glyphosate is not expected to change the acreage or the range of corn production.

Because changes in the acreage and locations for corn production using Pioneer 4114 Maize as a 

breeding foundation stacked with glyphosate resistance are not expected, no cumulative impacts 

have been identified for areas and acreage of corn production. 

5.3 CUMULATIVE IMPACTS: AGRONOMIC PRACTICES: TILLAGE, CROP 

ROTATION, AND AGRONOMIC INPUTS

5.3.1 Tillage and Crop Rotation

As discussed in Subsection 4.2.2 – Agronomic Practices, a determination of nonregulated status 

of Pioneer 4114 Maize is not expected to result in changes in current corn agronomic practices, 

as Pioneer 4114 Maize contains identical genetic elements to and requires the same cultivation 

practices as currently-cultivated GE corn varieties, such as 1507 x 59122 Maize. 

USDA-APHIS has determined that there are no past, present, or reasonably foreseeable actions 

that would aggregate with impacts of the proposed action to affect changes in tillage or crop 

rotation. Pioneer’s studies demonstrate Pioneer 4114 Maize is essentially indistinguishable from 

other corn varieties used in terms of agronomic characteristics and cultivation practices, such as 

1507 x 59122 Maize (Pioneer, 2011b). As noted in the introduction to this section, the GE 

parents of a stacked 4114/glyphosate-resistant hybrid were previously reviewed and determined 

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DRAFT PIONEER 4114 MAIZE

to be similar in agronomic characteristics to conventional corn varieties. Thus, any hybrid 

stemming from those two GE parents can be reasonably expected to be similar to conventional 

corn, and thus, benefit from the benefits of crop rotation. Additionally, because crop rotation 

strategies may be undertaken dependent on market conditions, any one hybrid stack is unlikely to 

affect these market conditions.

The current cultivation of glyphosate-resistant and glufosinate-resistant GE corn varieties 

suggests that growers have already adopted tillage and crop rotation practices that incorporate 

the two herbicides into the crop weed control program.

5.3.2 Agronomic Inputs

As discussed in Subsection 4.2.2 – Agronomic Practices, the cultivation of Pioneer 4114 Maize 

is unlikely to change current agronomic inputs for corn, including fertilizers, fungicides, 

insecticides, and herbicides because it is phenotypically identical to 1507 x 59122 Maize, a 

currently-available corn variety.

The cultivation of a stacked variety containing both insect-resistant and herbicide-resistant traits 

is consistent with current crop cultivation practices. As note in the introduction to this section, 

both 4114 and any nonregulated glyphosate-resistant variety were previously reviewed and 

determined to be similar in agronomic characteristics and cultivation requirements as 

conventional corn. Because of these agronomic and cultivation similarities with conventional 

corn, any offspring produced from these two GE parents will also likely be similar to 

conventional corn in agronomics and cultivation requirements.

The stacking of beneficial traits represents an increasing proportion of commercially-available 

corn varieties (see Table 2-1 in Subsection 2.2.2.3). Data presented by USDA-NASS suggests 

that corn varieties containing stacked traits are increasing in popularity, with approximately 52% 

of the total corn acreage in 2012 cultivated in stacked varieties (USDA-NASS, 2012b). As noted 

in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, there are several 

commercially available corn varieties that contain a combination of insect-resistant and 

glufosinate- and glyphosate-resistant traits. The factors discussed in Subsection 2.2 –

Agricultural Production of Corn that influence the grower’s selection of insect-resistant varieties, 

and the consequent application or avoidance of various insecticides are not changed by the 

cultivation of a hybrid stack because the current trend to reduce insecticide use in reliance on the 

incorporated Bt proteins is expected to continue (see, Brookes and Barfoot, 2010; Brookes et al., 

2012). This stacked variety would present another grower option for cultivating a Bt corn variety.

The addition of glyphosate resistance to the Pioneer 4114 events is not expected to require a 

change in the refuge strategies for managing insect resistance associated with the expression of 

the Cry proteins. As discussed in Subsection 2.4.1.2 – Invertebrates, refuge strategies are part of 

an insect resistance management strategy to delay the development of insect resistance to the 

expressed Cry proteins. Growers planting a stacked hybrid incorporating glyphosate resistance 

with the Pioneer 4114 Maize would need to ensure that their refuge strategy incorporated the 

appropriate herbicide-resistant corn varieties. The Genuity® SmartStax® hybrid, listed in 

Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis is an example of a 

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DRAFT PIONEER 4114 MAIZE

conventional hybrid containing traits resistant to both herbicides and presenting a convenient 

refuge strategy (see Monsanto, 2012). There are no cumulative impacts associated with 

insecticide use or refuge strategies associated with the cultivation of this hybrid. Refuge 

strategies are presented again in the Animal Communities analysis below.

With regard to potential changes in use of certain herbicides, as noted in Subsection 4.2.2 –

Agronomic Practices, corn containing traits resistant to glufosinate was cultivated on 

approximately 16% of the total corn acreage in 2010 (GfK Kynetec, 2010), but in that same time 

period, glufosinate was applied to only 2% of the corn acreage (USDA-NASS, 2011a). The 

cultivation of a corn variety exhibiting resistance to both glufosinate and glyphosate provides the 

grower with the option to apply herbicides with two different modes of action to control hard-tocontrol weeds. As discussed in Subsections 2.2.2, Agronomic Inputs, and 2.4.2, Plant 

Communities, growers continually adapt weed management strategies to manage hard-to-control 

weeds (Norsworthy et al., 2012; Vencill et al., 2012). Weed control methods differ depending on 

a number of factors including regional practices, grower resources, and crop trait; the techniques 

may be direct (e.g., mechanical, biological, and chemical) or indirect (e.g., cultural) (Hoeft et al., 

2000). Mechanical controls include a reversion to tillage, and chemical controls include the use 

of herbicides with alternative modes of action, such as auxin growth regulators, amino acid 

inhibitors, chlorophyll pigment inhibitors, or lipid biosynthesis inhibitors (Ross and Childs, 

2011; Norsworthy et al., 2012; Vencill et al., 2012). The practice of using herbicides with 

alternative modes of action could potentially diminish the populations of glyphosate-resistant

weeds and reduce the likelihood of the development of new herbicide-resistant weed populations 

(Dill et al., 2008; Duke and Powles, 2008; Owen, 2008; Duke and Powles, 2009b; Pioneer, 

2011b; Norsworthy et al., 2012; Vencill et al., 2012). These alternative weed management 

strategies are already widely used, and growers cultivating hybrid varieties resistant to both 

glyphosate and glufosinate are already able to take advantage of this strategy. These strategies 

are unlikely to change after the development of a 4114/glyphosate-resistant maize variety. The 

extent to which growers adopt this strategy will be contingent upon their response to the 

emergence of these weeds in their fields.

As discussed in Agronomic Practices (Subsections 2.2.2 and 4.2.2), the use of glufosinate on 

total corn acres has remained stable and low over the past decade (2-6% of total U.S. corn acres 

treated with glufosinate during 2001-2011) (Pioneer, 2012) To the extent that growers recognize 

the value in cultivating a stacked hybrid allowing the use of herbicides with multiple modes of 

action, the cultivation of varieties stacking Pioneer 4114 Maize with glyphosate resistance may 

allow growers to substitute glufosinate or glyphosate or both for other herbicides such as atrazine 

and metolachlor, as well as avoid reverting to conventional tillage (Vencill et al., 2012). As 

noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, there are 

several commercial varieties containing these same resistance traits already on the market and 

the development of a hybrid containing the traits of Pioneer 4114 Maize and glyphosate-resistant

are unlikely to change these current practices. On Roundup Ready® varieties, glyphosate is 

applied in many formulations post-emergence, in application rates ranging from 0.56 to 1.12 lb 

ae/acre (Loux et al., 2011). Glyphosate also is commonly used in conjunction with many other 

herbicides as a tank mix for both pre-plant/pre-emergence and post-emergent weed control up 

through the 12-leaf stage or until the corn reaches a height of 30 inches (see, e.g., Loux et al., 

2011). Hybrids combining resistance to both herbicides will provide growers with the 

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opportunity to apply tank mixes of either glyphosate or glufosinate with other herbicides for 

control of mixed weeds, and may be valuable in providing alternative controls to growers 

managing glyphosate-resistant weeds (Pioneer, 2012). As noted in Subsection 5.1 – Assumptions 

Used for the Cumulative Impacts Analysis, there are several other commercial hybrids currently 

cultivated that also are resistant to both glyphosate and glufosinate. The application of both 

herbicides to a corn crop is thus not a new event.

As previously noted, long-term trends related to herbicide use resulting from the use of GE 

technologies are the subject of intense debate (Benbrook, 2009; Brookes and Barfoot, 2010; 

Benbrook, 2012; Brookes et al., 2012). For example, Benbrook has recently published an 

analysis of the impacts of GE crops on pesticide use in the United States (Benbrook, 2012). In 

this publication, he estimates that herbicide-resistant crop technology has led to a 239 million kg 

increase in herbicide use in the United States between 1996 and 2011 and that Bt crops have 

reduced insecticide applications by 56 million kg over the same time period. Although

Benbrook's conclusion regarding a reduction in insecticide related to the use of Bt crops is 

consistent with the findings of other analysts, his analysis of trends in herbicide use is based on 

assumptions that may lead to overestimates of herbicide use in herbicide-resistant crop programs, 

including assumptions of herbicide usage on conventional crops that may be underestimated, 

extrapolation of trends to years where no USDA data are available, and not accounting for the 

role of increased crop acreage in the estimated increases in herbicide use. (Brookes et al., 2012). 

Further, Benbrook’s analysis fails to consider the differing environmental profiles of herbicides 

used, particularly the substitution of relatively environmentally benign products for those with 

less environmentally friendly profiles (Brookes and Barfoot, 2012). In contrast to Benbrook's 

findings, Brookes and Barfoot (2012) estimate that GM crop adoption in the United States

reduced the use of pesticides in the United States by 246 million kg compared to what might 

reasonably be expected if GM crops were no longer available.

Growers are already cultivating stacked hybrids presenting the same traits as a 4114/glyphosate 

resistant stack; to accomplish this, these growers have already adopted cultivation practices, 

including managing agronomic inputs for fertilizer, herbicides, pesticides and fungicides 

appropriate for these stacked hybrids. As discussed in this subsection, there are no changes in 

practices expected to accommodate such new hybrids; moreover, these new hybrids can be 

reasonably expected to replace cultivation of some of these existing hybrid varieties.

Consequently, overall impacts to agronomic practices associated with the adoption of such 

stacked varieties are not expected, and no cumulative impacts have been identified for agronomic 

practices associated with corn production. 

5.4 CUMULATIVE IMPACTS: ORGANIC CORN FARMING AND SPECIALTY CORN 

SYSTEMS

5.4.1 Organic Corn Farming

A determination of nonregulated status of Pioneer 4114 Maize is not expected to change the 

market demands for GE corn or corn produced using organic methods. A determination of

nonregulated status of Pioneer 4114 Maize would add another GE corn variety to the 

conventional corn market. Based upon recent trend information, adding GE varieties to the 

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market is not related to the ability of organic production systems to maintain their market share. 

Since 1994, 25 GE corn events or lines have been determined by USDA-APHIS to be no longer 

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

Protection Act of 2000. Between 2000 and 2008, the total acreage associated with the organic 

production of corn increased from 78,000 to approximately 195,000 acres, despite concurrent 

increases in conventional corn acreage (USDA-NASS, 2012a). As discussed in Subsection 2.2.3

– Organic Corn Farming and Specialty Corn certified organic corn acreage is a relatively small 

percentage of overall corn production in the United States. The most recently available data 

show 169,000 acres of certified organic corn production in 2011, which represented

approximately 0.20% of the 92 million acres of corn planted in 2011 (USDA-NASS, 2012a). The 

approximately 169,000 acres in 2011 represent a decrease from the approximately 195,000 

certified organic corn acres cultivated in 2008 (USDA-NASS, 2012a).

These acreage trends suggest that adding a new GE corn variety, in this case a new breeding 

stock stacked with glyphosate resistance, is not related to the ability of an organic production 

systems to maintain their market share. As Table 4-1 illustrates, corn varieties containing the 

same traits as Pioneer 4114 Maize have been in commercial cultivation for over a decade. Corn 

varieties resistant to glyphosate and no longer subject to the regulatory requirements of 7 CFR 

Part 340 or the plant pest provisions of the Plant Protection Act of 2000 have been on the United 

States market since 1996 (see http://www.aphis.usda.gov/biotechnology/not_reg.html). The 

glyphosate-resistant varieties are already widely cultivated, based on the percentage of corn 

currently treated with glyphosate (noted in Subsection 2.2 – Agronomic Inputs as 66% of the 

acreage, ~57 million pounds) (USDA-NASS, 2011b; USDA-NASS, 2011a).

Based on these trends, and the corresponding production systems already in place to maintain 

varietal integrity, USDA-APHIS has determined that there are no cumulative impacts to organic 

corn production from a determination of nonregulated status for Pioneer 4114 Maize.

5.4.2 Specialty Corn Production 

A determination of nonregulated status of Pioneer 4114 Maize is not expected to change the 

market demands for GE corn or corn produced using specialty systems. A determination of 

nonregulated status of Pioneer 4114 Maize would add another GE corn variety to the corn 

market. 

As discussed in Subsection 5.4.1 – Organic Corn Farming, corn varieties containing the same 

traits as Pioneer 4114 Maize have been in commercial cultivation for over a decade. Corn 

varieties resistant to glyphosate and no longer subject to the regulatory requirements of 7 CFR 

Part 340 or the plant pest provisions of the Plant Protection Act of 2000 have been on the United 

States market since 1996, and currently occupy a substantial part of the market. As discussed in 

Organic Corn Farming and Specialty Corn Systems (Subsections 2.2.3 and 4.2.3), growers 

already consider corn identity protection as part of their management strategies, from planting 

through harvest.

Based on Pioneer’s demonstration that there are no changes in agronomic characteristics and 

cultivation practices, and because the market share of specialty corn varieties is unlikely to 

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change by the introduction of Pioneer 4114 Maize and hybrids based on this variety, USDAAPHIS has determined that there are no past, present, or reasonably foreseeable changes that 

would impact specialty corn producers and consumers. 

5.5 CUMULATIVE IMPACTS: SOIL QUALITY

USDA-APHIS has not identified any cumulative impacts from the use of Pioneer 4114 Maize 

and its hybrids to soil quality. Pioneer has compared phenotypic, agronomic, and cultivation 

characteristics between Pioneer 4114 Maize and control corn hybrids. Pioneer 4114 Maize

requires the same soil, fertilizer, water, and pest management practices as conventional corn, 

including the currently-available 1507 x 59122 Maize (Pioneer, 2011b). Additionally, Pioneer 

4114 Maize also contains identical introduced genetic elements as 1507, 59122, and 1507 x 

59122 Maize. Consequently, the phenotypic, agronomic, and ecological data presented by 

Pioneer support the conclusion by USDA-APHIS that Pioneer 4114 Maize would not result in 

any substantial modification in soil properties that are not already found in conventional corn 

production practices (Pioneer, 2011b; USDA-APHIS, 2012e). 

As noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, the 

application and use of glyphosate on Roundup Ready® crops has been well-described in the EAs 

and EISs noted, and will not be further addressed here. Glyphosate is already used in corn in 

both conventional and Roundup Ready® varieties. The stacking of Pioneer 4114 Maize with a 

glyphosate-resistant variety complements the glyphosate-resistant crop by providing growers 

with the option to also apply glufosinate in those fields where glyphosate-resistant and inherently

hard-to-control weeds have emerged, allowing the grower to avoid reverting to tillage (Towery 

and Werblow, 2010). As discussed in Subsection 5.10 – Cumulative Impacts: Plant 

Communities, the use of herbicides with multiple modes of action must also take into 

consideration the emergence of weed varieties containing traits resistant to multiple herbicides. 

As glyphosate-resistant weed varieties have emerged, growers have returned to increased tillage 

as one of the weed management practices. As discussed in Soil Quality (Subsections 2.3.1 and

4.3.1), the adoption of conservation tillage has resulted in substantial improvements to soil health 

(Towery and Werblow, 2010). The cultivation of a corn variety stacking multiple modes of 

action, in this case, resistance to glufosinate ammonium, along with glyphosate-resistance, 

provides growers with an opportunity to maintain their conservation tillage strategies. As noted 

in Soil Quality (Subsections 2.3.1 and 4.3.1), maintaining conservation tillage will have a 

positive impact on soil quality by minimizing soil erosion, increased retention of organic matter, 

and increased water retention, among other benefits (Peet, 2001)

The analysis of the impacts of glyphosate use on soil resources is well documented (Duke et al., 

2012). Glyphosate is strongly adsorbed to soil, and once it enters the soil, it is essentially 

unavailable to plants because of this adsorption (US-EPA, 1993b; Giesy et al., 2000). Glyphosate 

has been shown to rapidly dissipate from most agricultural ecosystems across a wide range of 

soil and climatic conditions, from 1.7 to 141.9 days, with a median soil half-life (the time it takes 

for half of the glyphosate to dissipate in the soil) of 14.9 days, depending on a wide range of soil 

chemical and physical parameters (Giesy et al., 2000). Impacts of glyphosate to soil 

microorganisms are discussed in Subsection 5.11 – Cumulative Impacts: Soil Microorganisms.

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The potential future cultivation of a stacked variety and the associated use of glyphosate in 

addition to glufosinate are not expected to result in cumulative impacts to soil as corn varieties 

already exhibiting resistance to glufosinate and glyphosate exist and are already cultivated in the 

United States. 

Based on these findings, and because the amount of corn grown in the United States is unlikely 

to change by the introduction of Pioneer 4114 Maize, USDA-APHIS has determined that there 

are no cumulative impacts to soil quality. 

5.6 CUMULATIVE IMPACTS: WATER RESOURCES 

No cumulative impacts on water use have been identified for a determination of nonregulated 

status of Pioneer 4114 Maize or its hybrids. A determination of nonregulated status of Pioneer 

4114 Maize or its hybrids is not expected to change the water use and irrigation practices used in 

commercial corn production. As discussed above in Subsection 5.2 – Areas and Acreage of Corn 

Production, corn acreage will not increase as a result of cultivation of a hybrid combining 4114

with a glyphosate-resistant corn. Consequently, if corn acreage does not change as a result of this 

hybrid, then total water use trends by corn are unlikely to change.

Moreover, as presented in Subsection 4.3.2, Water Resources, for Pioneer 4114 Maize, and 

previous reviews of GE glyphosate-resistant corn, these varieties require typical moisture levels 

as conventional corn. Any offspring from 4114 and glyphosate-resistant corn will require similar 

moisture levels as its parents. Thus, any offspring from 4114 and glyphosate-resistant corn is 

likely to require similar moisture levels as conventional corn. Accordingly, no cumulative 

impacts to water use or irrigation in corn are anticipated.

The potential stacking of Pioneer 4114 Maize with a glyphosate-resistant variety provides 

growers with the option to apply herbicides with different modes of action, an approach 

proposed to mitigate the future development of herbicide-resistant weeds (Duke and Powles, 

2009b). Glyphosate-resistant crops, also identified as “Roundup Ready®” have been in 

commercial use since 1993 when glyphosate-resistant cotton was introduced. Glyphosateresistant corn was introduced in 1996 

(see http://www.aphis.usda.gov/biotechnology/not_reg.html). 

As noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, the 

application and use of glyphosate on Roundup Ready® crops has been well-described and will 

not be further addressed here. Glyphosate is already used in corn in both conventional and 

Roundup Ready® varieties. 

As discussed in Subsection 2.2.2.1 – Tillage, the adoption of conservation tillage has resulted in 

substantial improvements to soil health, and correspondingly, water quality, in those areas where 

the practice has been adopted (USDA-NRCS, 2006b; Givens et al., 2009; Towery and Werblow, 

2010; USDA-NRCS, 2010). The cultivation of a corn variety stacking multiple modes of action, 

in this case, resistance to glufosinate ammonium, along with glyphosate resistance, provides 

growers with an opportunity to preserve their conservation tillage strategies by combining 

herbicides with multiple modes of action rather than reverting to tillage. As discussed in Physical 

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Environment (Subsections 2.3 and 4.3), conservation tillage improves soil water retention and 

reduces soil erosion and nutrient runoff from the fields, each aspect of which benefits water 

quality (Peet, 2001). Maintaining conservation tillage will have a positive impact on water 

quality and a stacked corn product exhibiting Pioneer 4114 and glyphosate resistance may 

provide growers an opportunity to maintain conservation tillage practices that have already been 

adopted. 

The potential impacts of glyphosate use on water resources are well-documented in the previous 

EAs and EIS cited in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis. 

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 

(US-EPA, 1993b; Giesy et al., 2000). Relying on toxicological data, bioaccumulation and 

biodegradation studies, and acute and chronic tests on fish and other aquatic organisms, US-EPA

has determined that “the potential for environmental effects of glyphosate in surface water is 

minimal”, and has further noted a half-life in water of 8.1 days in an anaerobic aquatic 

environment and 7 days in an aerobic aquatic environment (US-EPA, 1993b).

The potential future cultivation of a stacked variety and the associated use of glyphosate in 

addition to glufosinate are not expected to result in cumulative impacts to water resources. The 

total amount of herbicide applied to hybrids based on the Pioneer 4114 Maize would be limited 

by application and per year rates approved by the US-EPA in the pesticide labels. As discussed 

in Subsection 1.3 – Coordinated Framework Review and Regulatory Review, the US-EPA’s 

pesticide registration process under FIFRA requires that US-EPA determine, through testing, that 

the pesticide will not cause unreasonable adverse effects on humans, the environment and nontarget species when used in accordance with the label. US-EPA’s label restrictions include a 

prohibition against applying glyphosate to water or to areas where surface water is present, or to 

intertidal areas below the mean high water mark (see, e.g., Prokoz, 2010). In 2010, fertilizer 

(primarily nitrogen) was applied to the majority of corn acres, and herbicides applied to 98% of 

planted corn (USDA-NASS, 2011c). Of the treated acres, glyphosate was the most commonly 

applied herbicide active ingredient that year (USDA-NASS, 2011c). When used consistent with 

registered uses and EPA-approved labels, glyphosate presents minimal risk to surface and 

groundwater. Irrigation from surface and subsurface sources can reduce water quantity and 

impact water quality by the used water acquiring increased sediment, nutrients, and chemicals 

adsorbed to soil that is subsequently leached to groundwater, or returned to surface water. 

Recent estimates indicate only 11.0 to 11.5% of corn acreage is irrigated in the U.S. (NCGA, 

2011). 

Based on these findings, and because the amount of corn grown in the United States is unlikely 

to change by the introduction of Pioneer 4114 Maize, USDA-APHIS has determined that there 

are no cumulative impacts to water resources. 

5.7 CUMULATIVE IMPACTS: AIR QUALITY

USDA-APHIS has determined that there are no past, present, or reasonably foreseeable actions 

that would aggregate with impacts of the proposed action that would have a negative impact on 

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air quality. The consequences of the Preferred Action Alternative on commercial corn production 

and the resulting air quality are similar to those expected for the No Action Alternative. 

The stacking of the Pioneer 4114 Maize with corn varieties containing resistance to the herbicide 

glyphosate is not expected to impact air quality. Glyphosate-resistant crops, also identified as 

Roundup Ready® have been determined by USDA-APHIS to have nonregulated status since 

1993 when glyphosate-resistant cotton was introduced. Glyphosate-resistant corn was introduced 

in 1996 (see http://www.aphis.usda.gov/biotechnology/not_reg.html). As noted in Subsection 5.1 

– Assumptions Used for the Cumulative Impacts Analysis, the application and use of glyphosate 

on Roundup Ready® crops has been well-described in the EAs and EISs noted, and will not be 

further addressed here. Glyphosate is already used in corn in both conventional and Roundup 

Ready® varieties. 

Some agricultural practices, including tillage and equipment use, can affect air quality through 

emissions from soil and equipment (US-EPA, 2012b). Cultivation of a stacked corn variety, 

containing resistance to glyphosate and glufosinate, would enable growers to use a combination 

of herbicides to control glyphosate-resistant weeds instead of returning to tillage practices (Owen 

et al., 2011a), reducing these impacts to air quality when compared with conventional tillage. As 

noted in Subsection 4.2 – Agricultural Production of Corn, any GE corn variety used as part of 

such a stack is likely to require the same cultivation requirements as conventional corn.

Glyphosate has a low vapor pressure and volatility from soils (US-EPA, 1993a). Glyphosate’s 

EPA-approved label provides measures for minimizing the potential air quality impacts from its 

use. When used in accordance with registered uses and EPA-approved labels, glyphosate poses 

minimal risks to air quality. Increasing or decreasing the amount of corn production acreage and 

its associated agronomic practices with emissions potentially impact air quality. Accordingly, 

there are no differences in agricultural practices between conventional and GE corn, whether a 

single trait event or a stack variety, that would impact air quality.

Based on these findings, and because the amount of corn grown in the United States is unlikely 

to change following a determination of nonregulated status of Pioneer 4114 Maize, USDAAPHIS has determined that there are no cumulative impacts to air quality. 

5.8 CUMULATIVE IMPACTS: CLIMATE CHANGE

USDA-APHIS has not identified any cumulative impacts for this issue. USDA-APHIS does not 

anticipate any changes in corn production practices or an expansion of corn acreage as a result of 

Pioneer 4114 Maize being no longer subject to the regulatory requirements of 7 CFR Part 340 or 

the plant pest provisions of the Plant Protection Act of 2000. 

Some agricultural practices, including tillage and equipment use, can contribute to climate 

change through releasing GHG emissions from soil and equipment (US-EPA, 2012b). 

Cultivation of a stacked corn variety, containing traits resistant to herbicides with different 

modes of action, in this case glyphosate and glufosinate, would enable growers to use a 

combination of herbicides to control glyphosate-resistant weeds instead of returning to 

conventional tillage practices (Towery and Werblow, 2010; Owen et al., 2011a). As noted in 

Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, corn products 

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containing these stacked traits are already commercially cultivated. As discussed above in 

Agronomic Practices (Subsections 2.2.2 and 4.2.2), Soil Quality (Subsections 2.3.1 and 4.3.1),

and Climate Change (Subsections 2.3.4 and 4.3.4), the adoption of herbicide-resistant crops and 

conservation tillage (or the avoidance of conventional tillage) has been identified as providing 

climate change benefits by increasing carbon sequestration in soils.

Based on these findings, and because the amount of corn grown in the United States is unlikely 

to change by the introduction of Pioneer 4114 Maize, USDA-APHIS has determined that there 

are no cumulative impacts to climate change. The use of Pioneer 4114 Maize as a foundation 

stock for production of hybrid varieties containing multiple stacked traits, including glyphosate 

resistance, is not expected to cause any cumulative effect on climate change. 

5.9 CUMULATIVE IMPACTS: ANIMAL COMMUNITIES 

USDA-APHIS has determined that there are no impacts from past, present, or reasonably 

foreseeable actions that would aggregate with effects of the proposed action to create cumulative 

impacts or reduce the long-term productivity or sustainability of any of the resources associated 

with the ecosystem in which Pioneer 4114 Maize is planted. 

5.9.1 Mammals and Birds

As discussed in Subsection 4.4 – Biological Resources, cultivation of Pioneer 4114 Maize, with 

the attendant accumulation of the Cry and PAT proteins providing insect resistance and herbicide 

resistance, is unlikely to have direct toxic effects on non-target organisms exposed to the Bt and 

pat genes and the corresponding Cry and PAT proteins (USDA-APHIS, 2012e). Therefore, the 

likelihood of adverse cumulative impacts on non-target organisms and biodiversity as a 

consequence of direct exposure to these proteins following the introduction of Pioneer 4114 

Maize is minimal. 

Glyphosate commonly is used in conjunction with many other herbicides as a tank mix for both 

pre-plant/pre-emergence weed control up through the 12-leaf stage or until the corn reaches a 

height of 30 inches (see, e.g., Loux et al., 2011). As noted above, glyphosate is not currently 

approved as a tank mix with glufosinate (see, Bayer, 2012). USDA-APHIS expects that any 

applications of glyphosate with glufosinate would be consistent with the currently approved 

rates. USDA-APHIS expects that both herbicides would be used in accordance with proposed 

labels. 

Stacked and pyramided crop varieties, exhibiting resistance to multiple herbicides and different 

forms of insect resistance, are widespread in the industry. As noted in Subsection 5.1 –

Assumptions Used for the Cumulative Impacts Analysis, stacked varieties exhibiting resistance 

to both glufosinate and glyphosate are already commercially cultivated. The introduction of 

hybrids based on Pioneer 4114 Maize have the potential to impact the rate of development of 

such varieties, as the availability of a foundation stock with the key genes on a single loci 

facilitates the inclusion of these gene traits in the development of other hybrid varieties (Pioneer, 

2011b). Although the rate of development of such hybrids may be affected by the availability of 

Pioneer 4114 Maize, hybrids based on the 1507 x 59122 variety are already in commercial 

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cultivation. In that regard, potential cumulative impacts from the cultivation of hybrids based on 

Pioneer 4114 Maize are the same as those already occurring under the No Action Alternative. 

Accordingly, USDA-APHIS expects that the associated cumulative impacts to animals of the 

availability of Pioneer 4114 Maize are negligible. 

Glyphosate is already widely used in corn (USDA-NASS, 2011a; USDA-NASS, 2011b). As 

noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, there are 

already several stacked varieties commercially available that contain traits resistant to both 

glufosinate and glyphosate. Glyphosate and glufosinate are already applied to corn varieties in 

accordance with the label restrictions; neither herbicide requires a label change to be used on a 

stacked hybrid variety. A hybrid based on Pioneer 4114 Maize also containing traits resistant to 

glyphosate would provide growers with another corn varietal option allowing the use of 

herbicides with multiple modes of action consistent with current practice. With regard to 

potential risk to mammals and birds from glyphosate expose, the EPA has conducted an 

ecological risk assessment for glyphosate and determined that there are minimal effects to birds 

and mammals (as well as fish and invertebrates) (see, e.g.,US-EPA, 1993b) There is no evidence 

that animal exposure to these herbicides would change from the current condition in the event of 

the cultivation of such a hybrid stack.

Growers generally have three options available to manage glyphosate-resistant weeds: 1) 

increase the frequency and magnitude of glyphosate applications within the restrictions of the

US-EPA labels; 2) use other herbicides in addition to glyphosate; or 3) increase the use of tillage 

and other mechanical controls (USDA-NRCS, 2010; Owen et al., 2011a). A hybrid incorporating 

glufosinate resistance and glyphosate resistance would achieve this goal. By combining 

herbicides offering alternative modes of action into their agronomic practices, the farmer can 

reduce the use of other herbicides which have been deployed to manage glyphosate-resistant 

weeds and continue to adopt conservation tillage systems. The associated adoption of 

conservation tillage and the reduced use of soil-applied herbicides have the potential to benefit 

animal communities in fields planted with Pioneer 4114 Maize (Eggert et al., 2004). The 

reduction in herbicide use and increase in conservation tillage both provide improved habitat for 

animals in and around the cornfields. 

5.9.2 Invertebrates

As discussed in Subsection 5.3.2 – Agronomic Inputs, the addition of a glyphosate resistance to 

the Pioneer 4114 events is not expected to require a change in the refuge strategies for managing 

insect resistance associated with the expression of the Cry proteins. As discussed in Subsection 

2.4.1.2 – Invertebrates, refuge strategies are part of an insect resistance management strategy to 

delay the development of insect resistance to the expressed Cry proteins. Growers planting a 

stacked hybrid incorporating glyphosate resistance with the Pioneer 4114 Maize would need to 

ensure that their refuge strategy incorporated the appropriate herbicide-resistant corn varieties.

The Genuity® SmartStax® hybrid, listed in Subsection 5.1 – Assumptions Used for the 

Cumulative Impacts Analysis and already on the market, is an example of a conventional hybrid 

containing traits resistant to both herbicides and presenting a convenient refuge strategy (see 

Monsanto, 2012). Invertebrate exposure to glyphosate has been addressed in the EAs and EISs 

noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis. Glyphosate 

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does not present an unreasonable risk to non-target invertebrates when used in accordance with 

the label use restrictions (see, e.g., US-EPA, 1993b). Similarly, insect-resistant Bt corn does not 

adversely affect non-target arthropods (e.g., (Balog et al., 2011) (Devos et al., 2012); (Rauschen 

et al., 2009); (Raybould and Vlachos, 2011) (Naranjo et al., 2005). 

Based on these findings, USDA-APHIS has determined that there are no past, present, or 

reasonably foreseeable actions that would aggregate with effects of the proposed action to affect 

animals associated with the determination of nonregulated status of Pioneer 4114 Maize.

5.10 CUMULATIVE IMPACTS: PLANT COMMUNITIES

5.10.1 Surrounding Landscapes and Other Vegetation in Cornfields

The potential impacts associated with exposure of plant communities to glyphosate has been 

addressed in previous USDA-APHIS analyses 

(see, http://www.aphis.usda.gov/biotechnology/not_reg.html). As discussed in Subsection 4.4.2 –

Plant Communities, the cultivation of Pioneer 4114 Maize does not require different 

management strategies than commercially available corn varieties, including commercial 

varieties based on 1507 x 59122 Maize.

Spray drift is a concern for non-target susceptible plants growing proximate to fields. Similar to 

glufosinate, US-EPA label restrictions are already in place for glyphosate to address the potential 

off-site drift of glyphosate and minimize this impact (see, e.g., Prokoz, 2010; Bayer, 2012). As 

noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, growers are 

already cultivating commercial hybrids containing traits resistant to both glufosinate and 

glyphosate. There is no evidence that the herbicide label restrictions or application requirements 

for either glufosinate or glyphosate would be any different than those currently used in the 

cultivation of the aforementioned conventional hybrid stacks that are already cultivated.

As discussed in the EAs and EISs referenced in Subsection 5.1 – Assumptions Used for the 

Cumulative Impacts Analysis, glyphosate is a non-selective foliar herbicide, with little or no 

herbicidal activity in soil (Duke et al., 2012). Some literature suggests that glyphosate adversely 

affects mineral nutrition in glyphosate-resistant crops, leading to increased plant disease, and that 

glyphosate-resistant crops are more susceptible to plant diseases due to other mechanisms (see, 

e.g., Kremer and Means, 2009; Duke et al., 2012). The latest literature on this concern questions 

the science and the significance of the reported impacts associated with the use of glyphosate, 

specifically noting that yield data for crops that are predominately glyphosate-resistant varieties 

does not support the contention that there are substantial mineral uptake or disease problems 

associated with the use of this herbicide (Duke et al., 2012). 

As noted on Tables 2-3 and 2-4, Italian Ryegrass, L. multiflorum, identified in Oregon 2010 is 

the only weed identified as resistant to both glufosinate and glyphosate (Heap, 2012). The 

International Survey of Herbicide Resistant Weeds (ISHRW) identifies many weeds containing 

traits for herbicide-resistance to multiple modes of action. Growers implementing weed control 

strategies incorporating herbicides expressing multiple modes of action will need to adhere 

closely to the Stewardship Strategy to avoid selecting for such species. For example, Barnyard 

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grass (Echinochloa crus-galli) is identified as resistant to synthetic auxins in the United States; 

whereas in Brazil, this same species also is identified as resistant to the ALS herbicides (Heap, 

2012). Kochia (K. scoparia) has been identified as resistant to both synthetic auxins and 

glyphosate in the United States (Heap, 2012). This weed, despite being identified as herbicideresistant in 1994, is not reported to be a major crop management problem (Wright et al., 2011).

As noted in Subsection 2.4.2 – Plant Communities, the preferred method to manage hard to 

control weeds involves, among other strategies, use of herbicides with multiple modes of action.

As noted in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, stacked 

hybrid varieties presenting the grower with options to consider herbicides with multiple modes 

of action, including resistance to both glyphosate with glufosinate, are already commercially 

available. Growers are already using both glyphosate and glufosinate to control weeds in similar 

stacked corn hybrids (see, e.g., Monsanto, 2012). The hybrid stack envisioned here would 

present growers with another management option for addressing these hard to control weeds 

similar to those varieties already on the market.

Based on these findings, USDA-APHIS has not identified any cumulative impacts to 

surrounding landscapes or weed control associated with potential stacking with a glyphosate 

resistance event.

5.10.2 Corn as a Weed or Volunteer

Pioneer has committed to preparing a Stewardship Strategy to preserve the effectiveness of the 

products associated with cultivation of future hybrids (Pioneer, 2012). Growers cultivating 

Pioneer 4114 Maize varieties would be expected to accept this stewardship plan as part of the 

technology agreement to purchase and cultivate the products (see also Pioneer, 2011c; Pioneer, 

2011a; Pioneer, 2012). As discussed in Agronomic Practices (Subsections 2.2.2 and 4.2.2), an 

essential aspect of these stewardship strategies is growers’ adherence to US-EPA’s approved 

label application rates, and the use of herbicides expressing multiple modes of action (Owen et 

al., 2011a). USDA-APHIS assumes that growers will use these herbicides in accordance with

US-EPA’s label restrictions, and that these label requirements are intended to minimize potential 

non-target impacts. 

The remainder of this analysis of potential cumulative impacts to plant communities focuses on 

the control of volunteer corn engineered to contain herbicide-resistant traits for herbicides with 

multiple modes of action. As stacked crops are developed containing multiple herbicide 

resistance traits, the options for volunteer control become more limited. 

Volunteer corn from a parent strain that exhibits glyphosate resistance might be controlled in a 

LibertyLink® crop with the use of glufosinate (Minnesota, 2009; Reddy, 2011). Alternatively, 

corn volunteers containing only the Pioneer 4114 Maize traits easily could be controlled by 

mechanical cultivation as well as readily available herbicides, including glyphosate, or other 

graminicides (Wozniak, 2002), provided that the Pioneer 4114 Maize or its progeny does not 

carry resistance to these other herbicides (e.g., accidental admixture or intentional or 

unintentional crossing of resistant varieties). As discussed in Subsection 2.4.2.2 – Corn as a 

Weed or Volunteer, herbicides recommended for control of volunteer corn in soybeans are the 

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ACCase inhibitors and certain ALS inhibitors. The ACCase inhibitors include two families of 

herbicides, the AOPP ACCases (e.g., the “fops,” such as quizalofop, fenoxaprop, and diclofop) 

and the cyclohexanediones (e.g., the “dims,” such as clethodim and sethoxydim) (Hager, 2009). 

Pioneer 4114 Maize is sensitive to the herbicides recommended for control to volunteer corn. 

Future control of volunteer corn will require the grower to understand the corn variety which has 

given rise to the volunteer plants. Volunteer corn representing a hybrid containing the traits of 

Pioneer 4114 Maize and glyphosate resistance, for example, would still be controllable by the 

ACCase inhibitors and certain ALS Inhibitors noted above (Hager, 2009). 

The ISHRW has identified several instances of weeds in the United States which show resistance 

to ACCase inhibitors and other modes of action (Heap, 2012). Adherence to the Stewardship 

Strategy is expected to minimize the development of weeds containing traits with resistance to 

multiple herbicides (Owen et al., 2011a). Although farmers may have to change their 

management strategies to adopt varieties stacked with the Pioneer 4114 Maize traits, these 

changes will not necessitate a major departure from well-established and broadly used 

agricultural protocols currently in use. 

Based on these findings, USDA-APHIS has determined that there are no past, present, or 

reasonably foreseeable actions that would aggregate with effects of the proposed action to affect 

plants associated with the determination of nonregulated status of Pioneer 4114 Maize.

5.11 CUMULATIVE IMPACTS: SOIL MICROORGANISMS

A determination of nonregulated status of Pioneer 4114 Maize is not expected to result in 

changes to current corn cropping practices. 

Stacked hybrids combining the traits of Pioneer 4114 Maize with nonregulated glyphosateresistant varieties would allow the application of glyphosate to Pioneer 4114 Maize in addition to 

glufosinate (Pioneer, 2012). As noted in Subsection 5.1 – Assumptions Used for the Cumulative 

Impacts Analysis, the cultivation of corn hybrids presenting the traits of Pioneer 4114 Maize and 

glyphosate resistance are already commercially available in the form of hybrids based on the 

1507 x 59122 hybrid (Pioneer, 2012). No impacts to soil microorganisms have been reported 

associated with the commercial cultivation of this variety.

Microorganisms produce aromatic amino acids through the shikimate pathway, similar to plants 

(USDA-FS, 2003). Because glyphosate inhibits this pathway, it could be expected that 

glyphosate would be toxic to microorganisms. However, field studies show that glyphosate has 

little effect on soil microorganisms; and, in some cases, field studies have shown an increase in 

microbial activity due to the presence of glyphosate (USDA-FS, 2003; Duke et al., 2012). 

Glyphosate use has been identified as potentially causing increases in certain disease-causing 

microbes (Fernandez et al., 2009; Kremer, 2010; Duke et al., 2012). However, reported increases 

in infections from pathogenic soil fungi have been determined to be more closely related to 

reduced tillage and continuous cropping using herbicide-resistant crops, rather than application 

of glyphosate (Fernandez et al., 2009; Duke et al., 2012). 

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Shan et al. (Shan et al., 2008) demonstrated that negligible levels of Cry1F toxins remained in 

soil following three years of continuous 1507 corn planting, suggesting that 1507 corn culture 

does not result in accumulation of the Cry1F toxin (Shan et al., 2008). Similar findings were 

obtained in a three-year study of MON88017 culture on soil levels of Cry3Bb1. This field study 

also compared rhizosphere bacteria in Bt corn fields and non-Bt corn fields, and found no 

significant differences (Miethling-Graff et al., 2010).

Based on these factors, USDA-APHIS has determined that there are no past, present, or 

reasonably foreseeable actions that would aggregate with effects of the proposed action to affect 

soil microorganisms.

5.12 CUMULATIVE IMPACTS: BIOLOGICAL DIVERSITY

A determination of nonregulated status for Pioneer 4114 Maize is not expected to result in 

changes in corn cultivation practices. Corn expressing the Cry proteins in Pioneer 4114 Maize 

has been cultivated commercially for many years. The commercial hybrid 1507 x 59122 Maize

has been available in the market since 2006 (Pioneer, 2012). Glufosinate is approved for use on 

corn (Bayer, 2012); glyphosate-resistant corn has been cultivated commercially since 1996 (see, 

http://www.aphis.usda.gov/biotechnology/not_reg.html). The glyphosate-resistant varieties are 

already widely cultivated, based on the percentage of corn currently treated with glyphosate 

(noted in Subsection 2.2 – Agronomic Inputs as 66% of the acreage, ~57 million pounds) 

(USDA-NASS, 2011b; USDA-NASS, 2011a).

As noted in the introduction to this section, glyphosate is not an approved tank mix partner with 

glufosinate for weed control in corn (see, e.g., Bayer, 2012). When growers adopt a stacked 

hybrid and elect to use both herbicides, the herbicides are applied sequentially, in accordance 

with label instructions, as part of the grower’s weed management strategies (see, e.g., Monsanto, 

2009). Tank mixes of glufosinate and glyphosate are in use for control of weeds in no-tillage 

weed control programs of certain crops. For example, glyphosate is a registered tank-mixture 

partner with glufosinate in the Liberty® cotton varieties (Koger et al., 2007). US-EPA’s review 

of pesticides takes into account potential non-target impacts. Total amounts of both herbicides 

applied to corn would be consistent with the label application rates. Pioneer has committed to 

develop an appropriate stewardship plan for corn varieties containing multiple herbicide 

resistance events (Pioneer, 2012). 

Potentially, Pioneer could add other insect-resistant traits with 4114. Effects on biodiversity of 

some of this traits have been examined previously: for example, corn stacked with Cry1Ab and 

Vip3Aa20 resulted in no significant differences between predator diversity and abundance, and 

fields planted with this stack were had a significantly more diverse arthropod community 

composition than fields treated with pyrethroids (Dively, 2005). Similarly, arthropod community 

composition did not significantly differ between fields planted with 1507 corn and fields planted 

with conventional corn (Higgins et al., 2009). A recent study focused specifically on syrphid 

diversity and abundance in MON88017 fields, MON8903 fields, and fields with both traits 

stacked together; there were no significant differences between them (Rosca and Cagan, 2013).

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Based on these factors, USDA-APHIS has determined that there are no past, present, or 

reasonably foreseeable actions that would aggregate with effects of the proposed action to affect 

biodiversity.

5.13 CUMULATIVE IMPACTS: GENE MOVEMENT

5.13.1 Vertical Gene Flow

USDA-APHIS has considered the potential cumulative impacts of vertical gene flow associated 

with a new stacked variety. As noted in Subsection 4.4.5 – Gene Movement, the possibility of 

gene movement from the host plant into native or feral populations of Zea species or wild or 

weedy relatives of corn has been evaluated by the US-EPA and determined not to be a concern in 

the continental United States (US-EPA, 2010e). 

USDA-APHIS has further considered vertical gene flow in its previous analysis in Subsection 

4.2.3 – Organic Corn Farming and Specialty Corn Systems, and has determined that standard 

management methods are available to control pollen drift in order to manage vertical gene flow.

These methods include having measures in place as part of seed certification and varietal 

protection to restrict pollen movement and gene flow between cornfields through the use of 

isolation distances, border and barrier rows, the staggering of planting dates, detasseling and 

hand pollination, and various seed handling, transportation and handling procedures (Wozniak, 

2002; Mallory-Smith and Sanchez-Olguin, 2011). 

Additionally, USDA-APHIS has previously considered the factors limiting gene movement 

between corn varieties related to weediness. As noted in Subsection 4.4.5 – Gene Movement, 

neither GE nor non-GE corn cultivars form self-sustaining populations outside of cultivation 

because of limitations in seed dispersal, germination, and seasonal requirements (US-EPA, 

2010e). As noted in the introduction to this section, there are several commercial hybrid varieties 

containing both glyphosate- and glufosinate-resistant traits; the cultivation of these varieties has 

not been reported to require a change in practices used to reduce vertical gene movement. 

There is no evidence to suggest that the stacking of the events conferring glyphosate resistance in 

a Pioneer 4114 Maize hybrid would require changes to the standard management measures or 

result in a change in the viability of corn cultivars outside of cultivation. Based on these findings,

USDA-APHIS has not identified any cumulative impacts to vertical gene flow associated with 

potential stacking with a glyphosate resistance event.

5.13.2 Horizontal Gene Transfer

Based on available scientific evidence, USDA-APHIS has not identified any cumulative impacts 

on horizontal gene movement that would occur from a determination of nonregulated status of 

Pioneer 4114 Maize. 

As discussed in Subsection 4.4.5.2 – Horizontal Gene Transfer, the movement of genes to 

unrelated species is highly unlikely. USDA-APHIS has considered horizontal gene transfer for 

multiple corn varieties and has found no evidence of naturally occurring transgene movement 

from GE crops to sexually incompatible species (USDA-APHIS, 2012e). Horizontal gene 

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transfer, resulting in the horizontal relocation of entire transgenes between unrelated species, 

including the regulatory portions of the DNA (those parts of the DNA which code for the 

production of the specific proteins in that relocated transgene), has been shown to occur in nature

over very long timelines (Clarke, 2007; Stewart, 2008). There is no evidence to suggest that the 

stacking of the events conferring glyphosate resistance in Pioneer 4114 Maize would alter this 

conclusion. Based on these findings, USDA-APHIS has not identified any cumulative impacts to 

horizontal gene transfer associated with potential stacking with a glyphosate resistance event.

5.14 CUMULATIVE IMPACTS: HUMAN HEALTH

The potential human health effects from the cultivation of glyphosate-resistant crops, with a 

corresponding analysis of the implications of the use of glyphosate, have been evaluated 

thoroughly in other EAs since the 1993 introduction of the first glyphosate-resistant crop 

product. (See: http://www.aphis.usda.gov/biotechnology/not_reg.html.) Glyphosate has been 

widely used on corn since the first glyphosate-resistant corn variety in 1996 was determined to 

be no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest 

provisions of the Plant Protection Act of 2000 (see Petition No. 96-317-01p, Monsanto’s 

Glyphosate-resistant and European Corn Borer-resistant Corn, 

at http://www.aphis.usda.gov/biotechnology/not_reg.html). The use of glyphosate herbicide does 

not appear to result in adverse effects on development, reproduction, or endocrine systems in 

humans and other mammals. Under present and expected use conditions, and when used in 

accordance with the US-EPA label, glyphosate does not pose a health risk to humans (US-EPA, 

1993b). US-EPA has established pesticide residue tolerances for glyphosate including 

concentration benchmarks for field corn for forage, grain, and stover (US-EPA, 1993b; US-EPA, 

2011a). Additionally, US-EPA has already considered registration issues in a stacked corn 

product expressing both the PAT and the EPSPS proteins in its analysis of the Genuity®

SmartStax® product (see US-EPA, 2011c). As noted in Subsection 5.1 – Assumptions Used for 

the Cumulative Impacts Analysis, these stacked products are already cultivated. USDA-APHIS

assumes that applications of glyphosate to a stacked corn variety incorporating the Pioneer 4114 

Maize traits will be conducted consistent with the label and consistent with the pesticide residue 

tolerances.

As discussed in Subsections 4.5.1 and 4.5.2 (Human Health and Worker Safety, respectively), 

Pioneer has determined that Pioneer 4114 Maize is the compositional equivalent of the 

conventional corn foundation varieties (e.g., 1507, 59122, and 1507 x 59122) (Pioneer, 2011b; 

USDA-APHIS, 2012e). Similar comparisons have been conducted by petitioners for all of the 

other nonregulated corn varieties with which Pioneer 4114 corn is likely to be stacked (see, e.g., 

APHIS PPRA and EA for the corn varieties presented on 

http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml). In each of these 

previous reviews, the US-FDA also has completed a consultation, including the most recent 

completed consultation for a CP4-EPSPS based glyphosate-resistant corn presented by Stine 

Seed (see, e.g., US-FDA, 2012). In these consultations, the US-FDA notes that the presence of 

the EPSPS protein does not give rise to any food or feed concerns. Humans are already exposed 

to the EPSPS protein in these glyphosate-resistant varieties. US-EPA has published an 

exemption from tolerance for the CP-4 EPSPS protein in all plants (US-EPA, 2007c) as well as 

tolerances for glyphosate residues (see US-EPA, 1980). It is highly unlikely that a conventional 

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hybrid stack of Pioneer 4114 Maize with a glyphosate-resistant variety would substantially 

change the composition of the resulting corn variety.

Bt corn has been found to have significantly fewer mycotoxins than conventional corn, which 

may have a beneficial impact on human health (Meissle et al., 2011).

Based on these factors, no substantial cumulative impacts to human health related to the No 

Action Alternative or a determination of nonregulated status of Pioneer 4114 Maize are 

expected, and no cumulative impacts have been identified.

5.15 CUMULATIVE IMPACTS: WORKER SAFETY 

As discussed in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, the 

cultivation of Pioneer 4114 Maize is limited to development as a foundation stock for the 

development of breeding pyramids or stacks with other herbicide-resistant and insect-resistant 

corn events. As discussed in Subsection 5.2 – Cumulative Impacts: Areas and Acreage of Corn 

Production, cultivation of a stacked variety presenting resistance to the two herbicides is not 

expected to increase the total acreage of corn production or the cultivation of other varieties of 

corn. Cumulative worker safety issues related to the continued use of US-EPA registered 

pesticides during conventional and GM corn production, including cultivation of hybrids should 

remain the same as the current condition.

The corn varieties with which Pioneer 4114 Maize is expected to be hybridized are already 

commercialized, and the herbicides and insecticidal properties associated with these products 

have already been evaluated and approved by USDA-APHIS, the US-FDA, and the US-EPA. 

As discussed in Section 4.5 – Public Health, an indirect benefit to worker safety arises from the 

cultivation of Bt corn varieties, in the reductions of applications of insecticides (US-EPA, 2010b; 

US-EPA, 2010a; US-EPA, 2010f). As noted in Subsections 2.2.2 – Agronomic Practices, and 

4.5.1 – Human Health, there has been a decline in the use of soil and foliar insecticides due, in 

part, to the adoption of Bt crops (Brookes et al., 2012). This trend is unlikely to change with the 

introduction of another corn hybrid combining the Pioneer 4114 Maize with a glyphosateresistant hybrid. 

The potential effects from the cultivation of glyphosate-resistant crops, with a corresponding 

analysis of the implications of the use of glyphosate, have been evaluated thoroughly in other

USDA-APHIS EAs since the 1993 introduction of the first glyphosate-resistant crop product. 

(See: http://www.aphis.usda.gov/biotechnology/not_reg.html.) Glyphosate has been widely used 

on corn since the first glyphosate-resistant corn variety in 1996 was determined to be no longer 

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

Protection Act of 2000 (see Petition No. 96-317-01p, Monsanto’s Glyphosate-resistant and 

European Corn Borer-resistant Corn, at http://www.aphis.usda.gov/biotechnology/not_reg.html). 

The use of glyphosate herbicide does not appear to result in adverse effects on development, 

reproduction, or endocrine systems in humans and other mammals (US-EPA, 1993b). Under 

present and expected use conditions, and when used in accordance with the US-EPA label,

glyphosate does not pose a health risk to humans, including workers (US-EPA, 1993b). 

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Based on these factors, no substantial cumulative impacts to worker safety related to the No 

Action Alternative or a determination of nonregulated status of Pioneer 4114 Maize are 

expected.

5.16 CUMULATIVE IMPACTS: ANIMAL FEED

The potential animal feed and animal health effects from the cultivation of glyphosate-resistant

crops, with a corresponding analysis of the implications of the use of glyphosate, have been 

evaluated thoroughly in other USDA-APHIS EAs since the 1993 introduction of the first 

glyphosate-resistant crop product, and are summarized in Subsection 4.2.2 – Agronomic

Practices (see: http://www.aphis.usda.gov/biotechnology/not_reg.html). The use of glyphosate 

herbicide does not appear to result in adverse effects on development, reproduction, or endocrine 

systems in animals (US-EPA, 1993b). In animals, most glyphosate is eliminated in feces and 

urine (US-EPA, 1993b). Under present and expected use conditions, and when used in 

accordance with the US-EPA label, glyphosate does not pose a health risk to animals as an 

animal feed concern. Pesticide residue tolerances for glyphosate include concentration 

benchmarks for field corn for forage, grain, and stover, and cover animal feed and animal tissues 

(US-EPA, 1993b; US-EPA, 2011a). USDA-APHIS assumes that applications of glyphosate to a 

stacked corn variety incorporating the Pioneer 4114 Maize traits will be conducted consistent 

with the label and consistent with the pesticide residue tolerances.

As discussed in Subsections 4.5.1 and 4.5.2 (Human Health and Worker Safety, respectively), 

Pioneer has determined that Pioneer 4114 Maize is the compositional equivalent of the 

conventional corn foundation varieties (e.g., 1507, 59122, and 1507 x 59122) (Pioneer, 2011b; 

USDA-APHIS, 2012e). Similar comparisons have been conducted by petitioners for all of the 

other nonregulated corn varieties with which Pioneer 4114 corn is likely to be stacked (see, e.g., 

APHIS PPRA and EA for the corn varieties presented on 

http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml). As noted in 

Subsection 5.14 – Cumulative Impacts: Human Health, in each of these previous reviews, the

US-FDA also has completed a consultation, including the most recent completed consultation for 

a CP4-EPSPS based glyphosate-resistant corn presented by Stine Seed (see, e.g., US-FDA, 

2012). In these consultations, the US-FDA notes that the presence of the EPSPS protein does not 

give rise to any animal feed concerns. Animals are already exposed to the EPSPS protein in these 

glyphosate-resistant varieties. US-EPA has published an exemption from tolerance for the CP-4 

EPSPS protein in all plants (US-EPA, 2007c) as well as tolerances for glyphosate residues for 

corn and corn products used in animal feed (see US-EPA, 1980). It is highly unlikely that a 

conventional hybrid stack of Pioneer 4114 Maize with a glyphosate-resistant variety would 

substantially change the composition of the resulting corn variety.

Should Pioneer stack 4114 with other insect-resistant traits in the future, there is no evidence of 

adverse effects to animal feed for Bt corn. For example, Lundry et al.(Lundry et al., 2013) found 

that SmartStax corn used for forage and animal feed was compositionally similar to conventional 

corn forage and animal feed. Similar results were obtained by McCann et al. (McCann et al., 

2007) in compositional analyses of MON88017 corn feed versus conventional corn feed.

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There is no evidence of negative growth and performance of animals fed Bt corn. A study of 

broiler chicken growth and survivorship following diets of either conventional corn or Bt11 corn 

found no significant differences (Brake et al., 2003), and Haryu et al. (Haryu et al., 2009) found 

similar results in a feeding study using mice. There were no significant growth differences 

between cattle fed MON89034 corn and conventional corn (Weber et al., 2011). Based on these 

factors, no cumulative impacts to animal feed have been identified related to the determination of 

nonregulated status of Pioneer 4114 Maize.

5.17 CUMULATIVE IMPACTS: DOMESTIC ECONOMIC ENVIRONMENT 

Based on the information described in Subsection 4.7.1 – Domestic Economic Environment,

USDA-APHIS concludes that a determination of nonregulated status of Pioneer 4114 Maize in 

itself will have no foreseeable adverse cumulative domestic economic effects. 

As discussed in Subsection 4.2 – Agricultural Production of Corn, Pioneer intends to limit the 

cultivation of Pioneer 4114 Maize to use as a foundation breeding stock for developing stacked 

or pyramided hybrids, combining the Pioneer 4114 Maize traits with corn varieties no longer 

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

Protection Act of 2000. For the purposes of this cumulative impacts analysis, USDA-APHIS

focuses its analysis on hybridization with a glyphosate-resistant corn variety for the reasons 

described in Subsection 5.1 – Assumptions Used for Cumulative Impacts Analysis. 

As discussed in Subsection 5.1 – Assumptions Used for the Cumulative Impacts Analysis, 

similar stacked varieties are already on the market. These varieties have the potential to improve 

grower management strategies for control of glyphosate-resistant weeds, and also improve 

grower economics. For example, a stacked hybrid combining both herbicide resistance traits 

would allow a grower to apply herbicides with two different modes of action. This herbicide 

management strategy is anticipated to sustain the long-term viability of the glyphosate-resistant

cropping system and preserve the benefits it provides to growers, the agricultural industry, and 

society. The adoption of such a diverse weed management strategy, incorporating several 

herbicides with alternative modes of action, may cost more initially than the conventional singleherbicide approach, but these costs are offset by an increase in yields in those fields where the 

weed pressure has been reduced (Weirich et al., 2011). There also is an inherent reduction in 

grower costs associated with a reduction in frequency of herbicide applications and in the 

continued avoidance of tillage through careful herbicide applications.

The volume of herbicides applied to corn, and the chemical composition of those herbicides, may 

change as a result of such stacked varieties. As discussed in Section 2 – Affected Environment, 

in 2005, 31% of the corn acreage was treated with glyphosate, and glufosinate use has been less 

than 6% of the acreage. As discussed in Subsection 4.7.1.2 – Preferred Alternative: Domestic 

Economic Environment, to the extent that the planting of hybrids based on Pioneer 4114 Maize 

results in a substitution of glufosinate or glyphosate for other herbicide applications to manage 

hard to control weeds, those who have reduced or eliminated these multiple herbicide 

applications or avoided a reversion to tillage to control these weeds might experience reduced 

input costs and a commensurate increase in net income.

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The cultivation of a stacked hybrid containing the traits from Pioneer 4114 Maize and resistance 

to glyphosate is not likely to impact grower demands for stacked products. Corn containing 

herbicide-resistant and insect-resistant traits is already cultivated on 52% of the United States 

acreage, with single trait corn only cultivated on 36% (21% herbicide-resistant and 15% insectresistant) (USDA-NASS, 2012b). Additionally, corn containing the traits from the Pioneer 4114 

Maize foundation stock, 1507 and 59122, already are cultivated on over 16% of domestic corn 

acreage.

Based on these factors, no net negative cumulative impacts on domestic economics have been 

identified associated with the cultivation of Pioneer 4114 Maize. If growers adopt the stacked 

variety and take advantage of the weed management strategy incorporating herbicides with 

different modes of action to control glyphosate-resistant weeds, local farm economics may 

improve. 

5.18 CUMULATIVE IMPACTS: TRADE ECONOMIC ENVIRONMENT

Current and historic economic evidence indicates that herbicide-resistant corn technology has the 

potential to increase domestic production at lower cost. This trend of lower production costs 

could enhance international corn trade by making U.S. corn and corn products more competitive 

in the global market. 

As noted in Subsection 4.7.2.2 – Preferred Alternative: Trade Economic Environment, Pioneer 

intends to submit applications to several international agencies prior to initiating commercial 

launch of the Pioneer 4114 Maize products (Pioneer, 2011b). Commercial launch of a stacked 

hybrid would be premised on the approval of the individual components of the hybrid, such as in 

Argentina, where the review focuses only on new aspects presented by the stack (Stein and 

Rodrigues-Cerezo, 2009), although other countries, e.g., Brazil and the EU, currently require 

specific approval for stacked hybrids (Stein and Rodrigues-Cerezo, 2009; James, 2011). As of 

2011, 26% of the total global lands committed to agriculture were cultivated with stacked 

varieties (James, 2011).

Based on the information described in Section 4 – Environmental Consequences, USDA-APHIS

has determined that there are no past, present, or reasonable foreseeable actions that in aggregate 

with effects of the proposed action would negatively impact the trade economic environment.

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6 THREATENED AND ENDANGERED SPECIES

6.1 USDA-APHIS’ APPROACH TO EVALUATION OF POTENTIAL IMPACTS TO 

THREATENED AND ENDANGERED SPECIES

Congress passed the Endangered Species Act (ESA) of 1973, as amended, 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 and Wildlife Service (USFWS) 

works in cooperation with the National Marine Fisheries Service (NMFS); other Federal, State, 

and local agencies; Tribes; non-governmental organizations; and private citizens. Before a plant 

or animal species can receive the protection provided by the ESA, it must first be added to the 

Federal list of threatened and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be endangered or 

threatened because of any of the following factors:

• The present or threatened destruction, modification, or curtailment of its habitat or range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• The inadequacy of existing regulatory mechanisms; and

• The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, in accordance with the ESA, protective measures 

apply to the species and its habitat. These measures include protection from adverse effects of 

Federal activities. 

Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or 

the NMFS, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the 

continued existence of a listed species or result in the destruction or adverse modification of 

designated critical habitat. It is the responsibility of the Federal agency taking the action to assess 

the effects of their action and to consult with the USFWS and NMFS if it is determined that the 

action “may affect” listed species or critical habitat. To facilitate USDA-APHIS’ ESA 

consultation process, USDA-APHIS met with the USFWS from 1999 to 2003 to discuss factors 

relevant to USDA-APHIS’s 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 of 2000 (Title IV of Public Law 106-224). This 

process is described in a decision tree document, which is presented in Appendix C. USDAAPHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of 

the ESA for biotechnology regulatory actions.

USDA-APHIS’ regulatory authority over GE organisms under the Plant Protection Act of 2000 

is limited to those GE organisms for which it has reason to believe might be a plant pest or those 

for which USDA-APHIS does not have sufficient information to determine that the GE organism 

is unlikely to pose a plant pest risk (7 CFR §340.1). USDA-APHIS does not have authority to 

regulate the use of any herbicide, including glufosinate. After completing a PPRA, if USDA138
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APHIS determines that Pioneer 4114 Maize does not pose a plant pest risk, then Pioneer 4114 

Maize would no longer be subject to the plant pest provisions of the Plant Protection Act of 2000 

or to the regulatory requirements of 7 CFR Part 340, and therefore, USDA-APHIS must reach a 

determination that the article is no longer regulated. As part of its EA analysis, USDA-APHIS is 

analyzing the potential effects of Pioneer 4114 Maize on the environment including any potential 

effects to threatened and endangered species and critical habitat. As part of this process, USDAAPHIS thoroughly reviews the genetically engineered product information and data related to the 

organism (generally a plant species, but also may be other genetically engineered organisms). 

For each transgene/transgenic plant, USDA-APHIS considers the following: 

• Reviews 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;

• Location(s) of the new transgene and its products (if any) produced in the plant and their 

quantity;

• Reviews of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact;

• Concentrations of any known plant toxicants, if applicable; 

• Sexual compatibility of the transgenic plant 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.

6.2 POTENTIAL EFFECTS OF THE CULTIVATION OF PIONEER 4114 MAIZE ON 

TES

In following this review process, USDA-APHIS, as described below, has evaluated the potential 

effects that a determination of nonregulated status of Pioneer 4114 Maize plants may have, if 

any, on Federally-listed TES and species proposed for listing, as well as designated critical 

habitat and habitat proposed for designation. 

Pioneer’s studies demonstrate that agronomic characteristics and cultivation practices required 

for Pioneer 4114 Maize are essentially indistinguishable from practices used to grow other corn 

varieties, including other herbicide-resistant varieties (Pioneer, 2011b; USDA-APHIS, 2012e). 

Pioneer 4114 Maize will be cultivated only as a foundation seed stock for the development of 

other hybrids, and hybrids based on Pioneer 4114 Maize are expected to replace other varieties 

of corn currently cultivated (Pioneer, 2011b; Pioneer, 2012). As noted in Subsection 2.2 –

Agricultural Production of Corn, corn is cultivated commercially in each of the continental 

United States. USDA-APHIS considered the potential for Pioneer 4114 Maize to extend the 

range of corn production and also the potential to extend agricultural production into new natural 

areas. As discussed in Subsection 4.2 – Agricultural Production of Corn, USDA-APHIS has 

determined that Pioneer 4114 Maize and hybrids based on this variety are unlikely to extend the 

range of corn production. Moreover, New acreage is not expected to be developed to 

accommodate the cultivation of hybrids based on Pioneer 4114 Maize (Pioneer, 2011b). 

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Accordingly, the issues discussed herein focus on the potential environmental consequences of 

the determination of nonregulated status of Pioneer 4114 Maize on TES species and critical 

habitat in the areas where corn is grown.

Based upon the scope of the EA and production areas identified in the Affected Environment 

section of the EA, USDA-APHIS obtained and reviewed the USFWS list of TES species (listed 

and proposed) for each state where corn is commercially produced from the USFWS 

Environmental Conservation Online System (ECOS; as accessed 4/15/2011 at 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp). 

USDA-APHIS focused its TES effects analysis on the implications of exposure to the Cry and 

PAT proteins in corn, the interaction between TES and the Pioneer 4114 Maize plant including 

potential for sexual compatibility and ability to serve as a host for a TES (Subsection 6.2.1 –

Potential Effects of Pioneer 4114 Maize on TES); and as part of its NEPA analysis considered 

the potential impacts of the use of glufosinate herbicide to non-target organisms and the natural 

environment (Subsection 6.2.2 – Potential Effects of the Use of Glufosinate Herbicides). 

6.2.1 Potential Effects of Pioneer 4114 Maize on TES

After reviewing the list of threatened and endangered plant species in the States where corn is 

grown, USDA-APHIS determined that Pioneer 4114 Maize would not be sexually compatible 

with any listed TES plant species or plant 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 Zea.

USDA-APHIS considered the possibility that Pioneer 4114 Maize could serve as a host plant for 

a TES species. A review of the species list reveals that there are no members of the genus Zea

that serve as a host plant for any TES.

Pioneer has presented data evaluating the agronomic and morphological characteristics of 

Pioneer 4114 Maize, including compositional and nutritional characteristics, safety evaluations 

and toxicity tests, comparing the product to a conventional hybrid corn variety (Pioneer, 2011b). 

Compositional elements compared included moisture, protein, fat, carbohydrates, ash, minerals, 

dietary fiber, essential and non-essential amino acids, fatty acids, vitamins, and anti-nutrients 

(Pioneer, 2011b). Allergenicity and toxicity studies included bioinformatics analyses, 

digestibility and acute protein toxicity studies (Pioneer, 2011b). No statistically meaningful 

differences were observed when comparing Pioneer 4114 Maize with the near isoline variety 

(Pioneer, 2011b; USDA-APHIS, 2012e). Pioneer 4114 Maize does not appear to present any 

changes in agronomic inputs, morphological characteristics or composition that would affect 

TES. 

The Cry proteins in Pioneer 4114 Maize are derived from Bt, subsp. aizawai (Cry1F) and Bt

strain PS149B1 (Cry 34Ab1 and Cry35Ab1) (USDA-APHIS, 2012e). The modifying PAT

enzyme, encoded by the pat gene, is derived from S. viridochromogenes (Pioneer, 2011b). Both 

B. thuringiensis and S. viridochromogenes are naturally occurring soil bacteria and are not 

pathogenic. Animals are regularly exposed to these organisms and their components without 

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DRAFT PIONEER 4114 MAIZE

adverse consequences (Hérouet et al., 2005; US-EPA, 2010b; US-EPA, 2010a; US-EPA, 2010c; 

Pioneer, 2011b; US-EPA, 2012d).

As noted throughout this document, the traits associated with Pioneer 4114 Maize are 

nonregulated and have been cultivated commercially for many years. The Cry1F protein and its 

associated genetic elements are identical to those in 1507 Maize, which had a determination of 

nonregulated status by USDA, registered by the US-EPA, and reviewed by the US-FDA in 2001 

(US-FDA, 2001; USDA-APHIS, 2001; US-EPA, 2010f; Pioneer, 2011b). The binary Cry 

proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements are identical to those 

in 59122 Maize, which was reviewed by US-FDA in 2004, had a determination of nonregulated 

status by USDA in 2005, and registered by US-EPA since 2005 (US-FDA, 2004; USDA-APHIS, 

2005; US-EPA, 2010f; Pioneer, 2011b). Maize expressing the PAT protein has had a 

nonregulated status since 1995 and cultivated commercially in the United States since 1996 

(USDA-APHIS, 1995). The safety of the introduced proteins in Pioneer 4114 Maize has been 

evaluated previously by USDA-APHIS, the US-FDA and the US-EPA, and there is a history of 

safe use and exposure. There are no reports of potential impacts to TES or critical habitat 

associated with exposure to these proteins.

As discussed in Subsection 2.4.3 – Soil Microorganisms, there is little evidence that soil 

microorganisms or soil ecosystem level processes are negatively impacted by Bt proteins in soil 

or by the cultivation of GE crops (Icoz and Stotzky, 2008). Because of concerns of the potential 

impacts of cultivating GE crops with Bt proteins on soil communities, the decomposition rates of 

GE crops with Bt proteins versus non-GE crops have been studied (Icoz and Stotzky, 2008). 

Studies conducted under field conditions show the decomposition rates of Bt cotton and Bt corn 

did not differ from the decomposition rates of non-Bt cotton and corn (Lachnicht et al., 2004; 

Tarkalson et al., 2007).

Concerns have been raised regarding the potential exposure of non-target organisms to the Cry 

proteins. Pioneer has presented information on laboratory studies testing the potential impacts to 

representative species of interest and surrogate species (Pioneer, 2011b). Surrogate species are 

typically selected because they are amenable to the laboratory setting; are environmentally 

sensitive and representative of the agroecosystem; and can be used to predict potential impacts

on related non‐target organisms, including beneficial, threatened, or endangered species (Romeis 

et al., 2011). Surrogate species also are used because testing on TES is not permitted. 

The insecticidal Cry1F and Cry34/35Ab1 proteins have been assessed by laboratory studies to 

evaluate the specificity of these proteins to target insects. In general, only insect species within a 

given taxonomic order and closely related families are susceptible to a given insecticidal protein 

(Pioneer, 2011b). Cry1F is US-EPA labeled for protection against lepidopterans (butterflies and 

moths) and coleopterans (beetles). Target species of Lepidoptera include the European corn 

borer (O. nubilalis), fall armyworm (Spodoptera frugiperda), corn earworm (Helicoverpa zea), 

western bean cut worm (Striacosta albicosta (Smith)), black cutworm (Agrotis ipsilon), lesser 

corn stalk borer (Elasmopalpus lignosellus), southwestern corn borer (Diatraea grandiosella), 

and sugarcane borer (Diatraea saccharalis) (US-EPA, 2010b). Cry34/35Ab1 is US-EPA labeled 

for protection against Coleoptera, specifically northern corn rootworm (Diabrotica barberi), 

western corn rootworm (D. virgifera virgifera), and Mexican corn rootworm (D. virgifera zeae) 

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DRAFT PIONEER 4114 MAIZE

(US-EPA, 2010a). Cry34/35Ab1 also has activity for southern corn rootworm (Diabrotica 

undecimpunctata howardi) as determined by use in bioassays (US-EPA, 2010a).

Pioneer has presented the results of laboratory assays in which springtail and earthworms were 

exposed to the Cry proteins (Pioneer, 2011b). None of the soil dwelling species tested showed 

substantial adverse effects from the proteins and the margins of exposure were greater than 22‐

fold (Pioneer, 2011b). Additionally, soil dwelling non‐target organisms are unlikely to be 

exposed to concentrations of the Cry1F and Cry34/35Ab1 proteins in soil, as realistic 

environmental exposures are expected to be substantially lower based on protein degradation and 

lack of accumulation in soil (Pioneer, 2011b).

Pioneer also has presented the results of laboratory assays in which representatives of 

coleopteran and lepidopteran species, targeted insect orders, as well as representatives of other 

insect orders not considered targets, were exposed to purified Cry proteins (Pioneer, 2011b). The 

representative coleopteran species were the Ladybird beetle (H. convergens and C. maculata), 

the representative lepidopteran species was the Monarch butterfly (D. plexippus), and insects 

representing other orders were parasitic wasps (N. vitripennis), the green lacewing (C. carnea), 

and the honeybee (A. mellifera) (Pioneer, 2011b). In addition, a representative of a non-target 

invertebrate order was tested, the water flea (Daphnia magna) (Pioneer, 2011b). None of the 

tested species showed significant adverse effects from exposure to the proteins (Pioneer, 2011b).

Previous assessments of the Cry proteins in 1507 and 59122 Maize have found no impacts to 

TES (USDA-APHIS, 2001; USDA-APHIS, 2005; US-EPA, 2010b; US-EPA, 2010a). As of 

August 2012, 62 insect species are listed on the USFWS website as TES (US-FWS, 2012). 

Twenty‐two of these insects are Lepidoptera and 17 are Coleoptera, with the remaining 

representing insects of other orders. With the exception of two coleopteran species, the Salt 

Creek Tiger Beetle (Cicindela nevadica lincolniana) (US-FWS, 2010; US-FWS, 2011b) and the 

Casey’s June Beetle (Dinacoma caseyi) (US-FWS, 2011a), all of the species of Lepidoptera and 

Coleoptera currently listed were added prior to the granting of nonregulated status of 1507 and 

59122 Maize. Of the two newly listed species, only the Salt Creek tiger beetle, added to the TES 

list in 2005 (US-FWS, 2010; US-FWS, 2011b), is found in the Corn Belt. This beetle is found in 

Nebraska (Lancaster and Saunders counties), the third largest state for maize cultivation (USFWS, 2010; USDA-NASS, 2012b). However, the beetle’s critical habitat has been characterized 

as non‐vegetated stream banks or edges that are in saline or freshwater wetlands and the beetles 

prefer to be within a few meters of these. In addition, the Salt Creek Beetle is a member of the 

Carabidae beetle family, which is unrelated to the corn rootworm family, the Chrysomelidae. 

Therefore, it is unlikely that the Salt Creek tiger beetle will be exposed to the Cry34/35Ab1 

protein from 4114 Maize or will be impacted due to the specificity of the Cry34/35Ab1 protein 

to corn rootworm species.

The Casey's June beetle is found only in one area in the United States near Palm Springs, 

California (US-FWS, 2011a). This beetle's preferred habitat is sandy areas associated with desert 

scrub vegetation located on alluvial fans, much like the area it currently inhabits in Riverside 

County, California (US-FWS, 2011a). Although corn is grown in California, it is grown in 

counties farther north near San Francisco (USDA-NASS, 2012b). Based on preferred habitat, it 

is highly unlikely that these beetles will be exposed to the Cry34/35Abl protein from 4114 

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DRAFT PIONEER 4114 MAIZE

Maize. US-EPA also concluded that a review of the preferred habitats of other coleopteran 

species listed as endangered by the USFWS indicated that no exposure to harmful levels of the 

subject protein (Cry34/35Abl protein) would take place (US-EPA, 2010a) due to the lack of 

exposure and geographical and habitat limitations. These other coleopteran species are located in 

non-corn production areas and/or their habitat does not encompass agricultural areas.

For 1507 Maize, USDA considered the impact of the Cry1F protein on two lepidopteran species, 

the Karner blue butterfly (Lycaeides melissa samuelis) and Mitchell’s satyr butterfly

(Neonympha mitchellii) (USDA-APHIS, 2001). USDA concluded that both species would not be 

expected to be present in or close to maize fields; therefore it is unlikely there would be any 

impact of 1507 Maize cultivation (USDA-APHIS, 2001). For 59122 Maize, USDA considered 

the impact on one primary threatened and endangered coleopteran species, the American burying 

beetle, Nicrophorus americanus (USDA-APHIS, 2005). Habitats in Nebraska where these 

beetles have been recently found consist of grassland prairie, forest edge and scrubland. From 

review of preferred habitats, this beetle is unlikely to be found in active maize fields and 

therefore would not be exposed substantially to the Cry34/35Ab1 protein from 4114 Maize 

(USDA-APHIS, 2005).

For other lepidopteran- and corn rootworm-resistant maize events, US-EPA has made similar 

conclusions for the Karner blue butterfly and the American burying beetle and has not identified 

any new TES that would be impacted by cultivation (US-EPA, 2009; US-EPA, 2010b; US-EPA, 

2010a). Furthermore, US-EPA examined the habitats of the other threatened and endangered 

insect species in the orders Diptera, Hemiptera, Odonata and Orthoptera and found that they 

primarily occupy dune, meadow or prairie, or open forest habitats and are not closely associated 

with row crop production, often times due to the specificity of the habitat of their host plants 

(US-EPA, 2010b; US-EPA, 2010a).

Similar to the conclusions for 1507 and 59122 Maize, it is unlikely that threatened and 

endangered species such as the Karner blue and Mitchell’s satyr butterflies and the American 

burying beetle, Casey’s June beetle and the Salt Creek tiger beetles would be affected by 4114 

Maize cultivation. Based on the constituent elements required in their habitat, Cry protein target 

insect specificity, and the lack of habitat overlap with regions of maize cultivation, cultivation of 

Pioneer 4114 Maize will have no effect on any listed threatened and endangered insects.

USDA-APHIS also considered the potential for exposure to the PAT protein. The pat gene 

expressing the PAT protein in Pioneer 4114 Maize was derived from S. viridochromogenes, a 

gram-positive soil bacterium (Pioneer, 2011b). The PAT protein is identical to the protein found 

in many commercially-available crops no longer subject to the plant pest provisions of the Plant 

Protection Act of 2000 and 7 CFR Part 340, including 1507 and 59122 Maize (USDA-APHIS, 

2001; USDA-APHIS, 2005). Following a determination of nonregulated status in 1995, maize 

expressing the pat gene has been cultivated commercially in the United States since 1996 

(USDA-APHIS, 1995). As with the discussion of the Cry proteins above, the PAT protein and its 

associated genetic elements are identical to those in 1507 Maize, which had a determination of 

nonregulated status by USDA, registered by the EPA, and reviewed by the US-FDA in 2001 

(US-FDA, 2001; USDA-APHIS, 2001; US-EPA, 2010f; Pioneer, 2011b). The same PAT protein 

is present in 59122 Maize, which was reviewed by US-FDA in 2004, had a determination of 

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nonregulated status by USDA in 2005, and registered by US-EPA since 2005 (US-FDA, 2004; 

USDA-APHIS, 2005; US-EPA, 2010f; Pioneer, 2011b). The US-EPA has approved a tolerance 

exemption for the PAT protein and the genetic material necessary for its production in all plants 

(US-EPA, 2007a). No impacts to humans or animals have been identified associated with 

exposure to the pat gene or the PAT protein.

The environmental safety of the PAT proteins has been extensively reviewed in international 

scientific, peer-reviewed journals (Hérouet et al., 2005). The PAT protein expressed in GM 

crops has been consumed by humans and animals since 1995 and have exhibited no 

significant adverse effects. The PAT protein mode of action is specific to the breakdown of 

ammonia in plant tissues. Because animals lack this enzymatic pathway (Hérouet et al., 

2005), and there is no mechanism to transfer this gene to unrelated plant species, USDAAPHIS limits its analysis of the implications of exposure to the PAT protein to the potential 

for gene movement to related TES corn species. This analysis also is relevant to 

considerations for the movement of the Cry proteins.

As discussed in Gene Movement (Subsections 2.4.5 and 4.4.5), the potential for gene 

movement between Pioneer 4114 Maize and related corn species is limited (Pioneer, 

2011b). As discussed in Subsection 2.1 – Corn Background Information, there is a rare, 

sparsely dispersed feral population of teosinte, a relative of Z. mays, reported in Florida 

(USDA-APHIS, 2012e); however, this plant is not listed as a TES. Moreover, where maize 

x teosinte hybrids have been identified in the field, they are found to exhibit low fitness and 

are unlikely to produce a second generation (USDA-APHIS, 2012e). None of the relatives 

of corn are Federally listed (or proposed) as endangered or threatened species (US-FWS, 

2012). The US-EPA has concluded that there is no substantial risk for gene capture and 

expression of the Cry proteins in weedy or wild relatives of corn in the United States (USEPA, 2010e). Accordingly, a determination of nonregulation of Pioneer 4114 Maize will not 

result in the movement of the PAT or Cry proteins to endangered or threatened species 

related to corn. 

Pioneer 4114 Maize does not present a potential as a weed or the potential to displace a TES. 

The agronomic and morphologic characteristics data provided by Pioneer were used in the

USDA-APHIS analysis of the weediness potential for Pioneer 4114 Maize, and evaluated for the 

potential to impact TES. Agronomic studies conducted by Pioneer tested the hypothesis that the 

weediness potential of Pioneer 4114 Maize is unchanged with respect to conventional corn 

(Pioneer, 2011b). No differences were detected between Pioneer 4114 Maize and nontransgenic 

near-isoline corn in growth, reproduction, or interactions with pests and diseases, other than the 

intended effect of herbicide resistance (USDA-APHIS, 2012e). Corn 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, 2012e). 

Based on the agronomic field data and literature survey on corn weediness potential, Pioneer 

4114 Maize is unlikely to affect TES as a troublesome or invasive weed (Pioneer, 2011b; USDAAPHIS, 2012e).

In addition to evaluating Pioneer’s comparisons of Pioneer 4114 Maize with the non-transgenic 

near-isoline hybrid variety for potential differences in agronomic characteristics and 

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DRAFT PIONEER 4114 MAIZE

morphology, USDA-APHIS also considers the US-EPA and US-FDA regulatory assessment in 

making its determination of the potential impacts of determination of nonregulated status of the 

new agricultural product. As discussed above in Animal and Plant Communities (Subsections 

4.4.1 and 4.4.2, respectively) and Public Health (Subsection 4.5), Pioneer has submitted food and 

feed safety and nutritional assessments for Pioneer 4114 Maize to the US-FDA. Exemptions 

from pesticide residue tolerance already exist for the Cry and PAT proteins (US-EPA, 2007a). 

After reviewing the possible effects of the nonregulation of Pioneer 4114 Maize, USDA-APHIS

has not identified any stressor that could affect the reproduction, numbers, or distribution of a 

listed TES or species proposed for listing. As a result, a detailed exposure analysis for individual 

species is not necessary. USDA-APHIS also considered the potential effect of the determination 

of nonregulated status of Pioneer 4114 Maize on designated critical habitat or habitat proposed 

for designation, and could identify no differences from effects that would occur from the 

production of other corn varieties. Corn 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, 2010e). 

Based on these factors, USDA-APHIS has concluded that the determination of nonregulated 

status of Pioneer 4114 Maize, and the corresponding environmental release of this corn variety 

will have no effect on listed species or species proposed for listing, and would not affect 

designated habitat or habitat proposed for designation. Because of this no-effect determination, 

consultation under Section 7(a)(2) of the Act or the concurrences of the USFWS or NMFS are 

not required. 

6.2.2 Potential Effects of the Use of Glufosinate Herbicides

USDA-APHIS met with USFWS officials on June 15, 2011 to discuss whether USDA-APHIS

has any obligations under the ESA regarding analyzing the impacts of herbicide use associated 

with all GE crops on TES. As a result of these joint discussions, USFWS and USDA-APHIS

have agreed that it is not necessary for USDA-APHIS to perform an ESA effects analysis on 

herbicide use associated with GE crops currently planted because US-EPA has both regulatory 

authority over the labeling of pesticides and the necessary technical expertise to assess pesticide 

effects on the environment under the FIFRA. USDA-APHIS has no statutory authority to 

authorize or regulate the use of glufosinate, or any other herbicide, by corn growers. Under

USDA-APHIS’ current Part 340 regulations, USDA-APHIS only has the authority to regulate 

Pioneer 4114 Maize or any GE organism as long as USDA-APHIS believes it may pose a plant 

pest risk. For GE organisms, USDA-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. Nevertheless, USDA-APHIS is aware that there may be potential 

environmental impacts resulting from the use of glufosinate on Pioneer 4114 Maize, including 

potential impacts on TES and critical habitat, based on assessments provided to it by the USEPA and as available in the peer-reviewed scientific literature. 

The following materials provide an overview of the US-EPA’s Endangered Species Protection 

Program (ESPP) and TES Evaluation Process, and a summary of the available information of 

potential environmental impacts resulting from glufosinate use on Pioneer 4114 Maize.

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DRAFT PIONEER 4114 MAIZE

6.2.2.1 EPA Endangered Species Protection Program (ESPP)

In 1988, Congress enacted Public Law 100-478 (October 7, 1988) to in part address the 

relationship between ESA and US-EPA’s pesticide labeling program (Section 1010), which 

required US-EPA to conduct a study, and report to Congress, on ways to implement US-EPA’s 

endangered species pesticide labeling program in a manner that both complies with ESA and 

allows people to continue production of agricultural food and fiber. This law provided a clear 

sense that Congress wanted US-EPA to fulfill its obligation to conserve listed species and at the 

same time consider the needs of agriculture and other pesticide users (70 FR 211 2005-11-02). 

In 1988 US-EPA established the ESPP to meet its obligations under the ESA. US-EPA ESPP

Web site30 describes the US-EPA assessment process for endangered species. Some of the 

elements of that process, reported on the Web site, are summarized below. The goal of US-EPA's 

ESPP is to carry out its responsibilities under the FIFRA in compliance with the ESA, without 

placing unnecessary burden on agriculture and other pesticide users consistent with Congress’ 

intent. US-EPA is responsible for reviewing pesticide information and data to determine whether 

a pesticide product may be registered for a particular use including those uses associated with the 

approval of biotechnology products. As part of that determination, the Agency assesses whether 

listed endangered or threatened species or their designated critical habitat may be affected by use 

of the pesticide product. All pesticide products that US-EPA determines “may affect” a listed 

species or its designated critical habitat may be subject to the ESPP. If limitations on pesticide 

use are necessary to protect listed species in areas where a pesticide may be used, the 

information is relayed through Endangered Species Protection Bulletins. Bulletins identify the 

species of concern and the pesticide active ingredient that may affect the listed species. They also 

provide a description of the protection measures necessary to protect the species, and contain a 

county-level map showing the geographic area(s) associated with the protection measures, 

depending on the susceptibility of the species. Bulletins are enforceable as part of the product 

label (http://www.epa.gov/oppfead1/endanger/basic-info.htm; last accessed on August 23, 2012 

and last updated by US-EPA on May 9, 2012).

6.2.2.2 EPA TES Evaluation Process

EPA evaluates listed species and their critical habitat concerns within the context of pesticide 

registration and registration review so that when a decision is made, it fully addresses issues 

relative to listed species protection. If a risk assessment determines that use limitations are 

necessary to ensure that legal use of a pesticide will not harm listed species or their critical 

habitat, US-EPA may either change the terms of the pesticide registration or establish 

geographically-specific pesticide use limitations (http://www.epa.gov/oppfead1/endanger/basicinfo.htm). 

EPA’s review of the pesticide and its registration decision is independent of USDA-APHIS’ 

review and regulatory decisions under 7 CFR 340. US-EPA does not require data or analyses 

30 http://www.epa.gov/espp/

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conducted by USDA-APHIS to complete its reviews. US-EPA evaluates extensive toxicity, 

ecological effects data, and environmental fate, transport and behavior data, most of which is 

required under FIFRA data requirements, to assess and determine how a pesticide will move 

through and break down in the environment. Risks to various taxa, e.g., birds, fish, invertebrates, 

plants and mammals are routinely assessed and used in US-EPA’s determinations of whether a 

pesticide may be licensed for use in the United States.

EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in 

place for all populations of non-target species, not just threatened and endangered species. USEPA has developed a comprehensive risk assessment process modeled after, and consistent with,

US-EPA’s numerous guidelines for EAs 

(http://www.epa.gov/oppfead1/endanger/consultation/ecorisk-overview.pdf). The result of an 

assessment, which may go through several refinements, is to determine whether the potential 

effects of a pesticide’s registration to a listed species will result in either a “no effect” or “may 

affect” determination. US-EPA consults on determinations that “may affect” a listed species or 

adversely modify its critical habitat (http://www.epa.gov/oppfead1/endanger). As a result of 

either an assessment or consultation, US-EPA may require changes to the use conditions 

specified on the label of the product. When such changes are necessary only in specific 

geographic areas rather than nationwide to ensure protection of the listed species, US-EPA

implements these changes through geographically-specific Endangered Species Protection 

Bulletins, otherwise, these changes are applied to the label for all uses of the pesticide.

6.2.2.3 Ecological Risks of Glufosinate

The US-EPA first registered glufosinate ammonium in 2000 as a non-selective foliar 

herbicide for use on a wide range of crops, including cotton (US-EPA, 2008b; US-EPA, 

2008a). In 2008, the US-EPA announced that it was undertaking a registration review of this 

product, and has published a final work plan for this process (US-EPA, 2008a). Assessments 

of the toxicity of glufosinate on Federally-protected species conducted by US-EPA indicated a

relatively low risk to animals but high risk to plants (US-EPA, 2008b). On an acute exposure 

basis, glufosinate is considered practically nontoxic to birds, mammals, and insects; slightly 

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 (US-EPA, 2008b). 

Non-target exposure for plants typically results from runoff or drift. Although animals also can 

be affected from runoff and drift, ingestion is often the most important exposure pathway. 

The US-EPA’s Final Work Plan for Registration Review for glufosinate (US-EPA, 2008a) states 

that:

The planned ecological risk assessment [ERA] will allow the Agency to 

determine whether glufosinate-ammonium use has “no effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their 

designated critical habitat. If the assessment indicates that glufosinate-ammonium 

“may affect” a listed species or its designated critical habitat, the assessment will 

be refined. The refined assessment will allow the Agency to determine whether 

the use of glufosinate-ammonium is “likely to adversely affect” the species or 

critical habitat or “not likely to adversely affect” the species or critical habitat. 

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DRAFT PIONEER 4114 MAIZE

When an assessment concludes that a pesticide’s use “may affect” a listed species 

or its designated critical habitat, the Agency will consult with the U.S. Fish and 

Wildlife Service and National Marine Fisheries Service (the Services), as 

appropriate.

Submittals to this analysis can be found at www.Regulations.gov under docket designation

EPA-HQ-OPP-2008-0190. 

In January 2013, the EPA made available the preliminary environmental fate and ecological risk 

assessment for the registration review of glufosinate, which can be found at 

www.Regulations.gov under docket designation EPA-HQ-OPP-2008-0190-0023 (US-EPA, 

2013). The preliminary conclusions for the potential direct affects to federally listed taxa 

associated with the registered uses of glufosinate indicated that there is the potential for direct 

effects from acute exposure to mammals and terrestrial and semi-aquatic plants, and chronic 

exposure to mammals as well as birds, reptiles, and amphibians. However, acute effects to 

mammals are not expected from applications at the maximum allowable labeled application rate 

for corn, and potential chronic effects are expected to birds, reptiles, and amphibians only at a 

rate equal to or exceeding 1.0 lb ai/A, with a minimum retreatment interval of 14 days. The 

maximum allowable labeled use on field corn is two applications at 0.4 ai/A with a minimum 14 

day interval between applications. For seed production the rate may be increased to 0.52 ai/A, 

also with a minimum 14 day interval. A single burndown application is permitted at 0.66 ai/A. 

Therefore, the only potential direct effects to listed species from applications of glufosinate on 

corn are to mammals and plants. The threat to plants is from spray drift, and the assessment 

provides a possible effects distance for aerial application on corn at a rate of 0.44 ai/A to be 30 

feet for monocots and 121 feet for dicots. (US-EPA, 2013). EPA is currently developing a 

registration review decision which will propose ways to mitigate risk (Weyrauch, 2013).

There are legal precautions in place to reduce the possibility of exposure and adverse impacts to 

TES from application of glufosinate to Pioneer 4114 Maize. These precautions include the USEPA pesticide label restrictions and best practice guidance provided by the herbicide 

manufacturer (see, e.g., Bayer, 2012). Adherence to these label use restrictions by the pesticide 

applicator will ensure that the use of the herbicide will not adversely affect TES or critical 

habitat. Labeled uses of glufosinate are approved pending the outcome of the US-EPA’s 

ecological risk analysis. No changes to the US-EPA approved label applications of glufosinate 

are proposed for cultivation of Pioneer 4114 Maize, but it is possible there may be label changes 

in the future for this and other corn varieties as a result of the registration review decision and 

possible consultation between EPA and USFWS/NMFS..

EPA has imposed specific label use restrictions for glufosinate ammonium use when applied 

with aerial equipment including “The product should only be applied when the potential for drift 

to adjacent sensitive areas (e.g., residential areas, bodies of water, known habitat for TES, nontarget crops) is minimal (e.g., when wind is blowing away from the sensitive areas)” (Bayer, 

2012)

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To facilitate pesticide applicators adherence to US-EPA label use restrictions for glufosinate 

ammonium, the label for glufosinate provides specific instructions for managing spray drift and 

cautions pertaining to applications around water so as to minimize potential effects to non-target 

organisms (Bayer, 2012). The label prohibits applications in conditions or locations where 

adverse impact on Federally listed endangered/threatened plants or aquatic species is likely 

(Bayer, 2012). Bayer also provides a technical and trade manual with additional guidance on the 

proper storage, handling and use of the product (Bayer, 2012).

These US-EPA label use restrictions and “best practice” guidance reduce the possibility of 

exposure and adverse impacts to TES from glufosinate application to Pioneer 4114 Maize 

varieties. US-EPA has considered potential impacts to TES as part of their registration and 

labeling process for glufosinate; and adherence to US-EPA label use restrictions by the pesticide 

applicator will ensure that the use of glufosinate will not adversely affect TES or critical habitat. 

As discussed previously, 1507 and 59122 Maize varieties also are resistant to glufosinate. These 

varieties, and the commercial hybrid 1507 x 59122, have been cultivated commercially for many 

years, with approximately 16% of the corn acreage in 2011 cultivated in these varieties (Pioneer, 

2012). USDA-APHIS assumes that some of the growers cultivating these varieties may have 

included the application of glufosinate to these acres. The US-EPA has not reported any impacts 

to TES from such use of glufosinate. 

Pioneer has announced its intention to market Pioneer 4114 Maize in other stacked or pyramided 

varieties by combining this trait via conventional hybridization techniques with other 

nonregulated varieties (Pioneer, 2011b). The stacked variety discussed in the cumulative impacts 

analysis will combine the Pioneer 4114 Maize variety with a glyphosate-resistant variety, 

providing the grower with the option to combine several herbicides with different modes of 

action for control of weeds. The implications of the use of glyphosate on TES has been 

addressed in numerous other USDA-APHIS EAs for products containing traits resistant to this 

herbicide. A list of the glyphosate-resistant products reviewed and granted nonregulated status 

by USDA-APHIS can be found at http://www.aphis.usda.gov/biotechnology/not_reg.html. The 

label use restrictions and best practices in place for the use of glyphosate are intended to reduce 

the possibility of exposure of TES to this herbicide.

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7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND 

TREATIES RELATING TO ENVIRONMENTAL IMPACTS

7.1 EXECUTIVE ORDERS WITH DOMESTIC IMPLICATIONS

The following two EOs require consideration of the potential impacts of the Federal action to 

minority and low income populations and children:

• EO 12898 (US-NARA, 2010), "Federal Actions to Address Environmental Justice in 

Minority Populations and Low-Income Populations," requires Federal agencies to 

conduct their programs, policies, and activities that substantially affect human health or 

the environment in a manner so as not to exclude persons and populations from 

participation in or benefiting from such programs. It also enforces existing statutes to 

prevent minority and low-income communities from being subjected to 

disproportionately high and adverse human health or environmental effects. 

• EO 13045, “Protection of Children from Environmental Health Risks and Safety 

Risks,” acknowledges that children may suffer disproportionately from environmental 

health and safety risks because of their developmental stage, greater metabolic activity 

levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by 

law and consistent with the agency’s mission) requires each Federal agency to identify, 

assess, and address environmental health risks and safety risks that may 

disproportionately affect children.

The No Action and Preferred Alternatives were analyzed with respect to EO 12898 and EO 

13045. Neither alternative is expected to have a disproportionate adverse effect on minorities, 

low-income populations, or children. 

Available mammalian toxicity data associated with the Cry and PAT proteins establishes the 

safety of Pioneer 4114 Maize and its products to humans, including minorities, low income 

populations, and children who might be exposed to them through agricultural production and/or 

processing. No additional safety precautions would need to be taken. 

Human toxicity also has been evaluated thoroughly by the US-EPA in its development of 

pesticide labels for glufosinate (Bayer, 2012). Pesticide labels include use precautions and 

restrictions intended to protect workers and their families from exposures. It is reasonable to 

assume that growers will adhere to these US-EPA herbicide use precautions and restrictions. As 

discussed in Subsection 4.5 – Public Health, the potential use of glufosinate on Pioneer 4114 

Maize at the proposed application rates would be no more than rates currently approved by the

US-EPA and should not to have adverse impacts to human health when used in accordance with 

label instructions. It is expected that US-EPA would monitor the use of Pioneer 4114 Maize to

determine impacts on agricultural practices, such as chemical use, as they have done previously 

for herbicide-resistant products.

As discussed in Subsection 4.2 – Agricultural Production of Corn the cultivation of GE corn 

varieties with herbicide-resistant traits no longer subject to the regulatory requirements of 7 CFR 

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Part 340 or the plant pest provisions of the Plant Protection Act of 2000 has been associated with 

a decrease and/or shift in pesticide applications for those who adopt these varieties that is either 

favorable or neutral with respect to environmental and human toxicity. The determination of 

nonregulated status of this variety provides growers with alternative herbicide options with 

different modes of action. As discussed in Subsections 2.1 – Corn Background Information and 

4.2 – Agricultural Production of Corn, the herbicide glufosinate is already labeled for use in 

corn. However, capture of a certain market segment by a GE crop does not automatically result 

in a corresponding application of the agronomic inputs associated with the GE event. This is 

specifically evidenced in the case of the glufosinate-resistant corn. Market segment data would 

suggest that glufosinate ammonium is already widely used in corn; in 2010, approximately 16% 

of the total corn acreage in the United States was planted with corn varieties resistant to 

glufosinate. However, the use of glufosinate on total corn acres has remained stable and low over 

the past decade (2% - 6% of the total U.S. corn acres) (GfK Kynetec, 2010; Pioneer, 2011b; 

Pioneer, 2012).

The US-EPA also has considered human health in its review of the Cry proteins under the PIPs 

analysis under FIFRA (see US-EPA, 1998; US-EPA, 2010b; US-EPA, 2010a) and the 

determination of exemptions from tolerance for the PAT protein and the Cry proteins under 

FFDCA (see US-EPA, 2007a). 

Based on these factors, the determination of nonregulated status of Pioneer 4114 Maize is not 

expected to have a disproportionate adverse effect on minorities, low income populations, or 

children. 

The following EO addresses Federal responsibilities regarding the introduction and effects of 

invasive species:

• EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal agencies take action 

to prevent the introduction of invasive species, to provide for their control, and to 

minimize the economic, ecological, and human health impacts that invasive species 

cause. 

Corn is not listed in the United States as a noxious weed species by the Federal government, nor 

is it listed as an invasive species by major invasive plant databases. Corn does not possess 

characteristics such as resistance for a variety of habitat conditions, rapid growth and 

reproduction, aggressive competition for resources, and the lack of natural enemies or pests. 

Non-engineered corn, as well as other herbicide-resistant corn varieties, is widely grown in the 

United States. Based on historical experience with these varieties and the data submitted by the 

applicant and reviewed by USDA-APHIS, Pioneer 4114 Maize plants are sufficiently similar in 

fitness characteristics to other corn varieties grown currently and are not expected to become 

weedy or invasive(USDA-APHIS, 2012e). 

The following EO requires the protection of migratory bird populations:

• EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agencies to Protect 

Migratory Birds,” states that Federal agencies taking actions that have, or are likely to 

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have, a measurable negative effect on migratory bird populations are directed to develop 

and implement, within two years, a Memorandum of Understanding (MOU) with the Fish 

and Wildlife Service that shall promote the conservation of migratory bird populations. 

Data submitted by the applicant has shown no substantial difference in compositional and 

nutritional quality of Pioneer 4114 Maize compared with other GE corn or non-GE corn, apart 

from the presence of the Cry and PAT proteins. As previously discussed, the protein constituents 

expressed in Pioneer 4114 Maize have been cultivated in a wide variety of commercial corn 

strains since 1995. The migratory birds that forage in cornfields are unlikely to be affected 

adversely by ingesting Pioneer 4114 Maize and its products. 

The US-EPA has considered toxicity of glufosinate to birds in its registration review (US-EPA, 

2008a). Acute and chronic risk quotients for birds were determined to slightly exceed the levels 

of concern; however, this finding was based on the highest tested dose (US-EPA, 2008a). In tests 

of acute and chronic exposure, the US-EPA found that glufosinate was practically non-toxic to 

birds (US-EPA, 2008a).

Based on these factors, it is unlikely that the determination of nonregulated status of Pioneer 

4114 Maize will have a negative effect on migratory bird populations. 

7.2 INTERNATIONAL IMPLICATIONS

EO 12114 (US-NARA, 2010), “Environmental Effects Abroad of Major Federal Actions” 

requires Federal officials to take into consideration any potential environmental effects outside 

the United States, its territories, and possessions that result from actions being taken. 

USDA-APHIS has given this EO due consideration and does not expect a substantial

environmental impact outside the United States in the event of a determination of nonregulated 

status of Pioneer 4114 Maize. It should be noted that all the existing national and international 

regulatory authorities and phytosanitary regimes that currently apply to introductions of new 

corn cultivars internationally apply equally to those covered by an USDA-APHIS determination 

of nonregulated status under Part 340. 

Any international trade of Pioneer 4114 Maize and its products subsequent to a determination of 

nonregulated status for the product would be fully subject to national phytosanitary requirements 

and be in accordance with phytosanitary standards developed under the International Plant 

Protection Convention (IPPC, 2010). The purpose of the IPPC “is to secure a common and 

effective action to prevent the spread and introduction of pests of plants and plant products and 

to promote appropriate measures for their control” (IPPC, 2010). The protection it affords 

extends to natural flora and plant products and includes both direct and indirect damage by pests, 

including weeds. 

The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification 

among the nations that have signed or acceded to the Convention (172 countries as of March 

2010). In April 2004, a standard for Pest Risk Analysis (PRA) of living modified organisms 

(LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an 

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existing standard, International Standard for Phytosanitary Measure No. 11 (ISPM-11, Pest Risk 

Analysis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest 

risk and that a determination needs to be made early in the PRA for importation as to whether the 

LMO poses a potential pest risk resulting from the genetic modification. USDA-APHIS pest risk 

assessment procedures for genetically engineered organisms are consistent with the guidance 

developed under the IPPC. In addition, issues that may relate to commercialization and 

transboundary movement of particular agricultural commodities produced through biotechnology 

are being addressed in other international forums and through national regulations.

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on 

Biological Diversity (CBD) that established a framework for the safe transboundary movement, 

with respect to the environment and biodiversity, of LMOs, which include those modified 

through biotechnology. The Protocol came into force on September 11, 2003, and 160 countries 

are Parties to it as of December 2010 (CBD, 2010). Although the United States is not a party to 

the CBD, and thus not a party to the Cartagena Protocol on Biosafety, United States exporters 

will still need to comply with those regulations that importing countries which are Parties to the 

Protocol have promulgated to comply with their obligations. The first intentional transboundary 

movement of LMOs intended for environmental release (field trials or commercial planting) will 

require consent from the importing country under an advanced informed agreement (AIA) 

provision, which includes a requirement for a risk assessment consistent with Annex III of the 

Protocol and the required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and are 

covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post 

decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be 

subject to transboundary movement. To facilitate compliance with obligations to this protocol, 

the United States Government has developed a website that provides the status of all regulatory 

reviews completed for different uses of bioengineered products (NBII, 2010). 

USDA-APHIS continues to work toward harmonization of biosafety and biotechnology 

consensus documents, guidelines, and regulations, including within the North American Plant 

Protection Organization (NAPPO), which includes Mexico, Canada, and the United States, and 

within the Organization for Economic Cooperation and Development (OECD). NAPPO has 

completed three modules of the Regional Standards for Phytosanitary Measures (RSPM) No. 14, 

Importation and Release into the Environment of Transgenic Plants in NAPPO Member 

Countries (NAPPO, 2003).

USDA-APHIS also participates in the North American Biotechnology Initiative (NABI), a 

forum for information exchange and cooperation on agricultural biotechnology issues for the 

United States, Mexico, and Canada. In addition, bilateral discussions on biotechnology 

regulatory issues are held regularly with other countries including Argentina, Brazil, Japan, 

China, and Korea.

Pioneer has stated that regulatory submissions will be made in key United States maize export 

markets, including Canada, Japan, Mexico, Taiwan, South Korea and China (Pioneer, 2011b). 

Pioneer further notes that full commercial launch of any maize products containing Pioneer 4114 

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Maize will occur only after obtaining all necessary authorizations in the United States and key 

import countries with functioning regulatory processes (Pioneer, 2012). 

7.3 COMPLIANCE WITH CLEAN WATER ACT AND CLEAN AIR ACT

This EA evaluated the potential changes in corn production due to a determination of 

nonregulated status of Pioneer 4114 Maize. Cultivation of Pioneer 4114 Maize is not expected to 

lead to the increased production of corn in U.S. agriculture. 

There is no expected change in water use and quality due to the cultivation of Pioneer 4114 

Maize compared with current corn production. Also, there is no expected change in air quality 

associated with the cultivation of Pioneer 4114 Maize. 

Based on this review, USDA-APHIS concludes that the cultivation of Pioneer 4114 Maize would 

comply with the Clean Water Act and the Clean Air Act.

7.4 IMPACTS ON UNIQUE CHARACTERISTICS OF GEOGRAPHIC AREAS

A determination of nonregulated status of Pioneer 4114 Maize is not expected to impact unique 

characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and 

scenic areas, or ecologically critical areas.

Pioneer has presented results of agronomic field trials for Pioneer 4114 Maize. The results of 

these field trials demonstrate that there are no differences in agronomic practices between 

Pioneer 4114 Maize and non-GE hybrids. The common agricultural practices that would be 

carried out in the cultivation of Pioneer 4114 Maize are not expected to deviate from current 

practices, nor will the use of US-EPA registered pesticides. The product is expected to be 

deployed on agricultural land currently suitable for production of corn and replace existing 

varieties, and is not expected to increase the acreage of corn production. 

There are no proposed major ground disturbances; no new physical destruction or damage to 

property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease, 

or transfer of ownership of any property. This action is limited to a determination of 

nonregulated status of Pioneer 4114 Maize. This action would not convert land use to nonagricultural use and therefore would have no adverse impact on prime farm land. Standard 

agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be 

used on agricultural lands planted to Pioneer 4114 Maize, including the use of US-EPA

registered pesticides. The Applicant’s adherence to US-EPA label use restrictions for all 

pesticides is expected to mitigate potential impacts to the human environment. 

With regard to pesticide use, a determination of nonregulated status of Pioneer 4114 Maize is not 

likely to result in changes to the use of glufosinate on corn. USDA-APHIS assumes that growers 

who elect to cultivate commercial varieties based on the Pioneer 4114 Maize will adhere closely 

to US-EPA label use restrictions for all pesticides applied to their crop. 

All pesticides distributed or sold in the United States are subject to registration by the US-EPA

under authority of FIFRA. Glufosinate ammonium was first registered for use by the US-EPA in 

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2000. Glufosinate is currently undergoing registration review by the US-EPA. The US-EPA has 

published documents relevant to its glufosinate registration review decision, including a 

Summary Document, a Preliminary Work Plan, and a Final Work Plan Registration Review. (See 

the docket folder for US-EPA-HQ-OPP-2008-0190 at the Regulations.gov website.) The USEPA has completed preliminary human health and ecological effects analyses and has identified 

risk assessment data needs (US-EPA, 2008a). When these data are received, US-EPA intends to 

conduct an ecological and endangered species risk assessment and revisions to the human health 

dietary, residential, occupational, and aggregate risk assessments (US-EPA, 2008a). US-EPA

produced an estimated timeline for the completion of the final registration review, with a final 

decision due in late 2013.

Based on these findings, including the assumption that US-EPA label use restrictions are in place 

to protect unique geographic areas and that those label use restrictions are adhered to, a 

determination of nonregulated status of Pioneer 4114 Maize is not expected to impact unique 

characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and 

scenic areas, or ecologically critical areas. 

7.5 NATIONAL HISTORIC PRESERVATION ACT (NHPA) OF 1966 AS AMENDED 

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 

1) determine whether activities they propose constitute "undertakings" that have the potential to 

cause effects on historic properties and 2) if so, to evaluate the effects of such undertakings on 

such historic resources and consult with the Advisory Council on Historic Preservation (i.e., 

State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate. 

USDA-APHIS’ proposed action, a determination of nonregulated status of Pioneer 4114 Maize 

and products based on this variety, is not expected to adversely impact cultural resources on 

tribal properties. Any farming activity that may be taken by farmers on tribal lands would only 

be conducted at the tribe’s request; thus, the tribes would have control over any potential conflict 

with cultural resources on tribal properties.

USDA-APHIS’ Preferred Alternative would have no impact on districts, sites, highways, 

structures, or objects listed in or eligible for listing in the National Register of Historic Places, 

nor would it likely cause any loss or destruction of scientific, cultural, or historical resources. 

This action is limited to a determination of nonregulated status of Pioneer 4114 Maize. 

USDA-APHIS’ proposed action is not an undertaking that may directly or indirectly cause 

alteration in the character or use of historic properties protected under the NHPA. In general, 

common agricultural activities conducted under this action do not have the potential to introduce 

visual, atmospheric, or noise elements to areas in which they are used that could result in effects 

on the character or use of historic properties. For example, there is potential for audible effects 

on the use and enjoyment of a historic property when common agricultural practices, such as the 

operation of tractors and other mechanical equipment, are conducted close to such sites. A builtin mitigating factor for this issue is that virtually all of the methods involved would only have 

temporary effects on the audible nature of a site and can be ended at any time to restore the 

audible qualities of such sites to their original condition with no further adverse effects. 

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Additionally, these cultivation practices are already being conducted throughout the corn 

production regions. The cultivation of Pioneer 4114 Maize is not expected to change any of these 

agronomic practices that would result in an adverse impact under the NHPA.

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APPENDIX A – FEDERAL REGISTER NOTICE REGARDING PUBLIC INPUT IN 

DEREGULATION PROCESS

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APPENDIX B – BAYER LIBERTY® LABEL

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APPENDIX C – APHIS THREATENED AND ENDANGERED SPECIES DECISION 

TREE FOR US-FWS CONSULTATIONS

DECISION TREE ON WHETHER SECTION 7 CONSULTATION WITH FWS IS 

TRIGGERED FOR PETITIONS OF TRANSGENIC PLANTS

This decision tree document is based on the phenotypes (traits) that have been permitted for 

environmental releases under APHIS oversight (for a list of approved notifications and 

environmental releases, visit Information Systems for Biotechnology, at http://isb.vt.edu.) 

APHIS will re-evaluate and update this decision document as it receives new applications for 

environmental releases of new traits that are genetically engineered into plants.

BACKGROUND

For each transgene(s)/transgenic plant the following information, data, and questions will be 

addressed by APHIS, and the EAs on each petition will be publicly available. APHIS review will 

encompass:

• A review of the biology, taxonomy, and weediness potential of the crop plant and its 

sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and the 

nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the 

plant and their quantity;

• A review of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact;

• Determination of the concentrations of known plant toxicants (if any are known in the 

plant),

• Analysis to determine if the transgenic plant is sexually compatible with any threatened 

or endangered plant species (TES) or a host of any TES.

FDA published a policy in 1992 on foods derived from new plant varieties, including those 

derived from transgenic plants (http://vm.cfsan.fda.gov/~lrd/fr92529b.html

and http://vm.cfsan.fda.gov/~lrd/consulpr.html). The FDA’s policy requires that genetically 

engineered foods meet the same rigorous safety standards as is required of all other foods. Many 

of the food crops currently being developed using biotechnology do not contain substances that 

are substantially different from those already consumed by human and thus do not require premarket approval. Consistent with its 1992 policy, FDA expects developers to consult with the 

agency on safety and regulatory questions. A list of consultations is available 

at http://vm.cfsan.fda.gov/~lrd/biocon.html. APHIS considers the status and conclusion of the 

FDA consultations in its EAs. 

Below is a description of our review process to whether a consultation with U.S. Fish and 

Wildlife Service is necessary.

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If the answer to any of the questions 1-4 below is yes, APHIS will contact FWS to determine if a 

consultation is required:

Is the transgenic plant sexually compatible with a TE plant31 without human intervention?

1. Are naturally occurring plant toxins (toxicants) or allelochemicals increased over the 

normal concentration range in parental plant species?

2. Does the transgene product or its metabolites have any significant similarities to known 

toxins32?

3. Will the new phenotype(s) imparted to the transgenic plant allow the plant to be grown or 

employed in new habitats (e.g., outside agro-ecosystem)33.

4. Does the pest resistance34 gene act by one of the mechanisms listed below? If the answer 

is YES then a consultation with U.S. Fish and Wildlife Service is NOT necessary.

A. The transgene acts only in one or more of the following ways:

i. As a structural barrier to either the attachment of the pest to the host, to penetration of 

the host by the pest, to the spread of the pest in the host plant (e.g., the production of 

lignin, callose, thickened cuticles);

ii. In the plant by inactivating or resisting toxins or other disease causing substances 

produced by the pest;

iii. By creating a deficiency in the host of a component required for growth of the pest 

(such as with fungi and bacteria);

iv. By initiating, enhancing, or potentiating the endogenous host hypersensitive disease 

resistance response found in the plant;

v. In an indirect manner that does not result in killing or interfering with normal growth, 

development, or behavior of the pest;

B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such 

as with coat protein, replicase, and pathogen virulence genes).

For the biotechnologist:

31 APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to the TES plant

32 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases 

like PIR, Swiss-Prot and HIV amino acid data bases.

33 Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, aluminum or heavy 

metals.

34 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels or mitigates a pest or 

effects any vertebrate or invertebrate animal, plant, or microorganism.

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Depending on the outcome of the decision tree, initial the appropriate decision below and 

incorporate its language into the EA. Retain a hard copy of this decision document in the 

petition’s file.

________ BRS has reviewed the data in accordance with a process mutually agreed upon with 

the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 

of the Endangered Species Act, is needed. APHIS has reached a determination that the release 

following a determination of nonregulated status would have no effects on listed threatened or 

endangered species and consequently, a written concurrence or formal consultation with the Fish 

and Wildlife Service is not required for this EA.

________ BRS has reviewed the data in accordance with a process mutually agreed upon with 

the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 

of the Endangered Species Act, is needed. APHIS reached a determination that the release 

following a determination of nonregulated status is not likely to adversely affect any listed 

threatened or endangered species and consequently obtained written concurrence from the Fish 

and Wildlife Service.

________ BRS has reviewed the data in accordance with a process mutually agreed upon with 

the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 

of the Endangered Species Act, is needed. APHIS reached a determination that the release 

following a determination of non-regulated status is likely to affect adversely one or more listed 

threatened or endangered species and has initiated a formal consultation with the Fish and 

Wildlife Service.

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