Monsanto Company Petition (07-CR-191U) for 

Determination of Non-regulated Status of Event MON 

87460 

OECD Unique Identifier: 

MON 87460-4 

Final Environmental Assessment 

November 2011 

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services 

USDA, APHIS 

4700 River Road 

Riverdale, MD 20737 

Fax: (301) 734-8669 

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. 

 
ii

TABLE OF CONTENTS 

LIST OF TABLES ......................................................................................................................... vi

LIST OF FIGURES ...................................................................................................................... vii

ACRONYMNS AND ABBREVIATIONS ................................................................................. viii

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

1.1 Regulatory Authority ............................................................................................................ 1

1.2 Regulated Organisms ............................................................................................................ 2

1.3 Petition for Determination of Nonregulated Status: MON87460 Drought Tolerant Corn ... 2

1.4 Purpose of Product ................................................................................................................ 3

1.5 APHIS Response to Petition for Nonregulated Status .......................................................... 3

1.6 Coordinated Framework Review .......................................................................................... 4

1.7 Public Involvement ............................................................................................................... 4

1.8 Issues Considered ................................................................................................................. 4

2 AFFECTED ENVIRONMENT .................................................................................................. 6

2.1 Agricultural Production of Corn ........................................................................................... 6

2.1.1 Current and Projected Acreage ...................................................................................... 6

2.1.2 Agronomic Practices ...................................................................................................... 7

2.1.2.1 Conventional and GE Corn Production Systems .................................................... 7

2.1.2.2 Specialty Corn Production Systems ...................................................................... 10

2.1.2.3 Organic Corn Production Systems ........................................................................ 11

2.2 Physical Environment ......................................................................................................... 12

2.2.1 Water Resources .......................................................................................................... 12

2.2.2 Soil ............................................................................................................................... 13

2.2.3 Air Quality ................................................................................................................... 13

2.2.4 Climate Change ............................................................................................................ 14

2.3 Animal and Plant Communities and Biodiversity .............................................................. 15

2.3.1 Animal Communities ................................................................................................... 15

2.3.2 Plant Communities ....................................................................................................... 16

2.3.3 Biodiversity .................................................................................................................. 17

2.3.4 Gene Flow .................................................................................................................... 17

2.3.4.1 Intraspecies Gene Flow ......................................................................................... 18

2.4 Human Health ..................................................................................................................... 20

2.4.1 Public Health ................................................................................................................ 20

2.4.2 Worker Safety .............................................................................................................. 20

2.5 Livestock Health ................................................................................................................. 21

2.6 Socioeconomic .................................................................................................................... 21

2.6.1 Domestic and Trade Economic Environment .............................................................. 21
iii

3 ALTERNATIVES..................................................................................................................... 25

3.1 No Action Alternative: Continuation as a Regulated Article ............................................. 25

3.2 Preferred Alternative: Determination that MON87460 corn is No Longer a Regulated 

Article ....................................................................................................................................... 25

3.3 Alternatives Considered but Rejected from Further Consideration .................................... 26

3.3.1 Prohibit Any MON87460 from Being Released .......................................................... 26

3.3.2 Approve the Petition in Part ......................................................................................... 26

3.3.3 Isolation Distance Between MON87460 and Non-GE Corn Production and 

Geographic Restrictions ........................................................................................................ 27

3.3.4 Requirement of Testing for MON87460 ...................................................................... 27

3.4 Comparison of Alternatives ................................................................................................ 28

4 ENVIRONMENTAL CONSEQUENCES ............................................................................... 29

4.1 Scope of Environmental Analysis ....................................................................................... 29

4.2 Other Assumptions ............................................................................................................. 29

4.3 Agricultural Production of Corn ......................................................................................... 30

4.3.1 Current Acreage and U.S. Cultivation Range .............................................................. 30

4.3.1.1 No Action Alternative: Current Acreage and U.S. Cultivation Range ................. 30

4.3.1.2 Preferred Alternative: Current Acreage and U.S. Cultivation Range ................... 31

4.3.2 Cropping Practices ....................................................................................................... 34

4.3.2.1 No Action Alternative: Cropping Practices .......................................................... 35

4.3.2.2 Preferred Alternative: Cropping Practices ............................................................ 35

4.3.3 Organic ......................................................................................................................... 37

4.3.3.1 No Action Alternative: Organic ............................................................................ 38

4.3.3.2 Preferred Alternative: Organic .............................................................................. 38

4.4 Physical Environment ......................................................................................................... 41

4.4.1 Water Usage and Water Quality .................................................................................. 41

4.4.1.1 No Action Alternative: Water Usage and Water Quality ..................................... 41

4.4.1.2 Preferred Alternative: Water Usage and Water Quality ....................................... 41

4.4.2 Soil ............................................................................................................................... 42

4.4.2.1 No Action Alternative: Soil .................................................................................. 42

4.4.2.2 Preferred Alternative: Soil .................................................................................... 42

4.4.3 Air Quality ................................................................................................................... 43

4.4.3.1 No Action Alternative: Air Quality ...................................................................... 43

4.4.3.2 Preferred Alternative: Air Quality ..................................................................... 43

4.4.4 Climate Change ............................................................................................................ 44

4.4.4.1 No Action Alternative: Climate Change ............................................................... 44

4.4.4.2 Preferred Alternative: Climate Change ................................................................. 44

4.5 Animal and Plant Communities .......................................................................................... 45

4.5.1 Animal Communities ................................................................................................... 45
iv

4.5.1.1 No Action Alternative: Animal Communities .................................................. 45

4.5.1.2 Preferred Alternative: Animal Communities ........................................................ 45

4.5.2 Plant Communities ....................................................................................................... 47

4.5.2.1 No Action Alternative: Plant Communities ...................................................... 47

4.5.2.2 Preferred Alternative: Plant Communities ........................................................ 47

4.5.3 Biodiversity ................................................................................................................ 49

4.5.3.1 No Action Alternative: Biodiversity ..................................................................... 50

4.5.3.2 Preferred Alternative: Biodiversity ....................................................................... 50

4.5.4 Gene Flow .................................................................................................................... 51

4.5.4.1 No Action Alternative: Gene Flow ....................................................................... 51

4.5.4.2 Preferred Alternative: Gene Flow ...................................................................... 51

4.6 Human Health ..................................................................................................................... 52

4.6.1 Public Health ................................................................................................................ 53

4.6.1.1 No Action Alternative: Public Health ................................................................... 53

4.6.1.2 Preferred Alternative: Public Health ..................................................................... 53

4.6.2 Worker Safety .............................................................................................................. 55

4.6.2.1 No Action Alternative: Worker Safety ................................................................. 55

4.6.2.2 Preferred Alternative: Worker Safety ................................................................... 55

4.7 Livestock Feed .................................................................................................................... 55

4.7.1 No Action Alternative: Livestock Feed ....................................................................... 55

4.7.2 Preferred Alternative: Livestock Feed ......................................................................... 55

4.8 Socioeconomic .................................................................................................................... 56

4.8.1 Domestic Economic Environment ............................................................................... 56

4.8.1.1 No Action Alternative: Domestic Economic Environment .................................. 58

4.8.1.2 Preferred Alternative: Domestic Economic Environment .................................... 58

4.8.2 Trade Economic Environment ..................................................................................... 63

4.8.2.1 No Action Alternative: Trade Economic Environment ........................................ 64

4.8.2.2 Preferred Alternative: Trade Economic Environment .......................................... 64

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

5.1 Assumptions used for Cumulative Impacts ........................................................................ 65

5.2 Cumulative Impacts: Current Acreage and U.S. Cultivation Range .................................. 65

5.3 Cumulative Impacts: Cropping Practices ........................................................................... 66

5.4 Cumulative Impacts: Organic ............................................................................................. 67

5.5 Cumulative Impacts: Water Usage and Water Quality ....................................................... 67

5.6 Cumulative Impacts: Soil .................................................................................................... 68

5.7 Cumulative Impacts: Air Quality ........................................................................................ 68

5.8 Cumulative Impacts: Climate Change ................................................................................ 68

5.9 Cumulative Impacts: Animal Communities ....................................................................... 69

5.10 Cumulative Impact: Plant Communities ........................................................................... 69
v

5.11 Cumulative Impacts: Biodiversity .................................................................................... 69

5.12 Cumulative Impacts: Gene Flow ...................................................................................... 70

5.13 Cumulative Impacts: Public Health .................................................................................. 70

5.14 Cumulative Impacts: Livestock Health ............................................................................. 70

5.15 Cumulative Impact: Domestic Economic Environment ................................................... 71

5.16 Cumulative Impact: Trade Economic Environment ......................................................... 71

6 THREATENED AND ENDANGERED SPECIES .................................................................. 72

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS ...................................................................... 76

7.1 Executive Orders with Domestic Implications ................................................................... 76

7.2 International Implications ................................................................................................... 81

7.3 Compliance with the Clean Water Act and Clean Air Act ................................................. 82

7.4 Impacts on Unique Characteristics of Geographic Areas ................................................... 82

7.5 National Historic Preservation Act (NHPA) of 1966 as Amended .................................... 83

7.6 International Impacts Analysis ........................................................................................... 84

7.6.1 Transboundary Impacts ................................................................................................ 84

8 REFERENCES ......................................................................................................................... 85

9 LIST OF PREPARERS............................................................................................................. 99

APPENDIX A. FDA BIOTECHNOLOGY CONSULTATION NOTE TO THE FILE (BNF NO. 

000116) ....................................................................................................................................... 102

APPENDIX B. POLLEN- AND GENE-MEDIATED GENE FLOW ...................................... 109

APPENDIX C. CHARACTERISTICS MEASURED FOR PHENOTYPIC, AGRONOMIC, 

AND ENVIROMENTAL INTERACTIONS ASSESSMENT OF MON 87460 ....................... 115

 
vi

LIST OF TABLES 

Table 1: Adoption of GE corn varieties by major U.S. corn production states, 2000-2010 .......... 8 

Table 2: Certified organic corn acreage by state with more than 1,000 acres of certified land in 

2007 and 2008. ............................................................................................................... 12 

Table 3: Relative importance of farms and corn in local economies. .......................................... 23 

Table 4: Summary of potential impacts and consequences of Alternatives. ............................... 28 

Table 5: Acreage for major field crops and Conservation Reserve Program (CRP) 

assumptions, long-term projections ............................................................................... 33 

Table 6: Percentage of herbicide-tolerant, insect-resistant, stacked trait, and total GE 

corn in select Great Plains states .................................................................................... 37 

Table 7: Non-organic and organic corn production (harvested acres) in 2007 ............................ 39 

Table 8: Minority populations in states where MON87460 may be adopted, 2008 .................... 76 

Table 9: Minority farmer populations in states where MON87460 may be adopted, 2007 ........ 77 

Table 10: Low income presence, 2008 ......................................................................................... 78 

 
vii

LIST OF FIGURES 

Figure 1: Corn, plant acres: 2009 ................................................................................................... 6

Figure 2: Irrigated corn for grain, harvest acres: 2007 ................................................................ 22

Figure 3: Average values for U.S. corn harvest and average annual precipitation (1971-2000) . 32

Figure 4: Herbicide application trends in U.S. corn production, 2000-2005. .............................. 37 

Figure 5: U.S. corn and CRP acreage between 1988 and 2010. .................................................. 47 

 
viii

ACRONYMNS AND ABBREVIATIONS 

AIA Advanced informed agreement 

AOSCA American Organization of Seed Certifying Agencies 

APHIS Animal and Plant Health Inspection Service 

BRS Biotechnology Regulatory Services (within USDA–APHIS) 

Bt Bacillus thuringiensis protein 

CAA Clean Air Act 

CBD Convention on Biological Diversity 

CEQ Council on Environmental Quality 

CFR Code of Federal Regulations (United States) 

CH4 methane 

CO carbon monoxide 

CO2 carbon dioxide 

CRP Conservation Reserve Program 

CSPB cold shock protein B 

cspB cold shock protein B gene 

DNA deoxyribonucleic acid 

DT drought tolerant 

EA environmental assessment 

EIS environmental impact statement 

EO Executive Order 

EPA U.S. Environmental Protection Agency 

EQIP The Environmental Quality Incentives Program 

ESA Endangered Species Act of 1973 

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act 

FFP food, feed, or processing 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FR Federal Register 

GDP gross domestic product 

GE genetically engineered 

GHG greenhouse gas 

GMO genetically modified organism 
ix

GRAS generally recognized as safe 

IP Identity Preservation 

IPCC Intergovernmental Panel on Climate Change 

ISPM International Standard for Phytosanitary Measure

IPPC International Plant Protection Convention

LMO living modified organisms 

MOE margin of exposure 

NO2 nitrogen dioxide 

N2O nitrous oxide 

NAAQS National Ambient Air Quality Standards 

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 

NOEL no observable effect level 

NPTII 

nptII 

neomycin phosphotransferase II protein 

neomycin phosphotransferase II protein gene 

NRC National Research Council 

PPRA Plant Pest Risk Assessment 

PPA Plant Protection Act 

PRA pest risk analysis 

RNA ribonucleic acid 

TES threatened and endangered species 

TSCA Toxic Substances Control Act 

U.S. United States 

USDA U.S. Department of Agriculture 

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

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

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

USDA-NOP U.S. Department of Agriculture-National Organic Program 

USC United States Code 

VOC volatile organic compound 

WPS Worker Protection Standard for Agricultural Pesticides 
1

1 PURPOSE AND NEED 

1.1 Regulatory Authority 

"Protecting American agriculture" is the basic charge of the United States Department of 

Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides 

leadership in ensuring the health and care of plants and animals. The agency improves 

agricultural productivity and competitiveness, and contributes to the national economy and the 

public health. USDA asserts that all methods of agricultural production (conventional, 

genetically engineered, and organic systems) can provide benefits to the environment, 

consumers, and farm income. 

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

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

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

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

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

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

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

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

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

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

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

which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when 

there is evidence of “unreasonable” risk. 

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

agencies involved in regulating GE organisms: USDA’s Animal and Plant Health Inspection 

Service (APHIS), the Food and Drug Administration (FDA), and the Environmental Protection 

Agency (EPA). 

APHIS is responsible for regulating GE organisms and plants under the plant pest provisions in 

the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment. 

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic 

Act. The FDA is responsible for ensuring the safety and proper labeling of all plant-derived 

foods and feeds, including those that are genetically engineered. To help developers of food and 

feed derived from GE crops comply with their obligations under Federal food safety laws, FDA 

encourages them to participate in a voluntary consultation process. All food and feed derived 

from GE crops currently on the market in the United States have successfully completed this 

consultation process. The FDA policy statement concerning regulation of products derived from 

new plant varieties, including those genetically engineered, was published in the Federal Register 

on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a 

consultation process to ensure that human food and animal feed safety issues or other regulatory 

issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food. 
2

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

Rodenticide Act (FIFRA). EPA also sets tolerance limits 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) and regulates certain biological control 

organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for 

regulating the sale, distribution and use of pesticides, including pesticides that are produced by 

an organism through techniques of modern biotechnology. 

1.2 Regulated Organisms 

The APHIS Biotechnology Regulatory Service’s (BRS) mission is to protect America’s 

agriculture and environment using a dynamic and science-based regulatory framework that 

allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by 

the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701–7772), regulate the 

introduction (importation, interstate movement, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions of the 

Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 

article if the donor organism, recipient organism, vector, or vector agent used in engineering the 

organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered 

a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe 

that the GE organism may be a plant pest or APHIS does not have information to determine if 

the GE organism is unlikely to pose a plant pest risk. 

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

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

Act or the regulations at 7 CFR 340. The petitioner is required to provide information under § 

340.6(c)(4) related to plant pest risk that the agency may use to determine whether the regulated 

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

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

provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant 

pest risk. 

1.3 Petition for Determination of Nonregulated Status: MON87460 Drought Tolerant Corn 

The Monsanto Company of St. Louis, MO, submitted a petition to APHIS in 2010 for 

determination of nonregulated status of Event MON87460 drought tolerant (DT) corn (hereafter 

referred to as MON87460) (Monsanto, 2010). In the event of a determination of nonregulated 

status, the nonregulated status of MON87460 would include MON87460, and any progeny 

derived from crosses between MON87460 and conventional corn and crosses of MON87460 

with other biotechnology-derived corn that have previously been determined to no longer be 

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

Protection Act. Event MON87460 is currently regulated under 7 CFR Part 340. Interstate 

movements and field trials of MON87460 have been conducted under permits issued or 

notifications acknowledged by APHIS since 2002. Data resulting from these field trials are 

described in the Monsanto Company petition (Monsanto, 2010). 
3

1.4 Purpose of Product 

MON87460 is designed to mitigate grain yield loss under water-limited conditions. As detailed 

in the Monsanto Company petition, the enhanced drought tolerance of MON87460 results from 

the introduction and controlled expression of cold shock protein B (cspB), a native ribonucleic 

acid (RNA) chaperone derived from Bacillus subtilis (Monsanto, 2010). The enhanced drought 

tolerant phenotype of MON87460 manifests primarily as reduced yield loss relative to 

conventional corn when subjected to water-limiting conditions. When MON87460 was 

subjected to well-watered conditions, grain yield for MON87460 was not notably different than 

conventional corn. Data provided by the Monsanto Company demonstrates that MON87460 

reduces yield loss under water-limiting conditions primarily by minimizing the effect of water 

deficiency on photosynthesis, stomatal conductance, and carbon fixation on corn growth and 

development, resulting in an increased number of kernels per ear (Monsanto, 2010). 

Drought is one of the major limiting factors in corn that prevents realization of optimum grain 

yield worldwide (Boyer, 1982). In North America alone, it is estimated that 40 percent of 

distributed crop loss insurance indemnities are due to sub-optimal water availability (Boyer, 

1982). In temperate zone areas of commercial corn production, average global annual losses due 

to moderate drought are approximately 15 percent, though losses can be much higher under 

conditions of severe drought (Barker et al., 2005). 

1.5 APHIS Response to Petition for Nonregulated Status 

Under the authority of the plant pest provisions of the Plant Protection Act and 7 CFR part 340, 

APHIS has issued regulations for the safe development and use of GE organisms. As required 

by 7 CFR 340.6, APHIS must respond to petitioners that request a determination of the regulated 

status of genetically engineered organisms, including GE plants such as MON87460 corn. When 

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

genetically engineered organism is unlikely to pose a plant pest risk. If APHIS determines based 

on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organism is unlikely to 

pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest 

provisions of the Plant Protection Act and 7 CFR part 340. 

APHIS has prepared this environmental assessment (EA) to consider the potential environmental 

effects of an agency determination of nonregulated status consistent with NEPA regulations (40 

CFR parts 1500-1508, 7 CFR part 1b, and 7 CFR part 372) and the USDA and APHIS NEPA 

implementing regulations and procedures. This EA has been prepared in order to specifically 

evaluate the effects on the quality of the human environment1

 that may result from a 

determination of nonregulated status of MON87460 corn. 

                                                      

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

relationship of people with that environment” (40 CFR §1508.14) 
4

1.6 Coordinated Framework Review 

MON87460 does not contain a biotechnology-derived PIP nor is it a biological control organism; 

thus, EPA does not regulate MON87460. MON87460 is within the scope of the FDA policy 

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

produced through genetic engineering. The Monsanto Company initiated the consultation 

process with FDA for the commercial distribution of MON87460, and submitted a safety and 

nutritional assessment of food and feed derived from MON87460 to the FDA on December 19, 

2008. Based on the information the Monsanto Company submitted, and as of December 2010 

(BNF No. 000116), FDA has no further questions regarding MON87460 drought tolerant corn 

(FDA, 2010). 

1.7 Public Involvement 

APHIS routinely seeks public comment on environmental assessments prepared in response to 

petitions seeking a determination of nonregulated status of GE organisms. APHIS does this 

through a notice published in the Federal Register. The issues discussed in this EA were 

developed by considering public concerns as well as issues raised in public comments submitted 

for other environmental assessments of GE organisms, concerns raised in lawsuits, as well as 

those issues that have been raised by various stakeholders. These issues, including those 

regarding the agricultural production of corn using various production methods, and the 

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

environmental impacts of MON87460. 

This EA, the petition submitted by the Monsanto Company (Monsanto, 2010), and APHIS’ Plant 

Pest Risk Assessment (USDA-APHIS, 2010) will be available for public comment for a period 

of 60 days (7 CFR § 340.6(d)(2)). Comments received by the end of the 60-day period will be 

analyzed and used to inform APHIS’ determination decision of the regulated status of 

MON87460 and to assist APHIS in determining whether an Environmental Impact Statement 

(EIS) is required prior to the determination decision of the regulated status of these corn lines. 

1.8 Issues Considered 

The list of resource areas considered in this EA were developed by APHIS through experience in 

considering public concerns and issues raised in public comments submitted for 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 in the past. The resource 

areas considered in this EA can be categorized as follows: 

 Management considerations: 

 Acreage and areas of corn production, 

– Cropping practices, 

– Specialty corn production. 

 Environmental considerations: 

– Water use and quality, 

– Soil, 

– Climate change, 
5

– Animals, 

– Plants, 

– Biological diversity, and 

– Gene movement. 

 Human health considerations: 

Public health, 

– Worker safety, and 

– Livestock feed. 

 Socioeconomic considerations: 

 Domestic economic environment, and 

 Trade economic environment. 

   
6

2 AFFECTED ENVIRONMENT 

2.1 Agricultural Production of Corn 

2.1.1 Current and Projected Acreage 

Corn (Zea mays L.), a member of the Maydeae grass family tribe, is an annual plant cultivated 

under a variety of production environments (Morris and Hill, 1998). In the U.S., corn is 

generally cultivated in temperate regions that provide sufficient moisture and an adequate 

number of frost-free days to reach maturity. U.S. corn production is primarily focused in the 

Corn Belt, an area that represents approximately 80 percent of annual U.S. corn production and 

includes Iowa, Illinois, Nebraska, and Minnesota, and parts of Indiana, South Dakota, Kansas, 

Ohio, Wisconsin, and Missouri (USDA-NASS, 2010b). Figure 1 presents the planted acres of 

corn in the U.S. in 2009 (USDA-NASS, 2010c). In general, the Corn Belt has an adequate 

combination of seasonal warm weather, rainfall, and favorable soil conditions for growth. While 

the Midwest, where approximately 65 percent of U.S. corn is produced, typically experiences a 

minimum of 30 inches of rainfall annually, the central part of the Great Plains (~26 percent of 

U.S. corn production) receives an average of 20 inches, making it less optimal for corn 

production (Lew, 2004). 

 Figure 1. Corn, planted acres in 2009. 

 Source: (USDA-NASS 2010c). 
7

The U.S. is the world's largest producer and exporter of corn. In 2009, the U.S. produced 

approximately 40 percent of the world’s total corn harvest (FAOSTAT, 2008). During the 2009 

market year, 86.4 million acres of corn were planted and approximately 13.1 billion bushels of 

corn were harvested in the U.S. (USDA-NASS, 2010b). In terms of domestic use, animal 

feed/residuals and biofuel production utilized the majority of produced corn (39 and 35 percent, 

respectively), whereas lesser amounts were used for exportation to foreign markets (15 percent), 

ending stock seed (13 percent), food and industrial purposes (10 percent), and seed stock for 

hybrid seed production (0.17 percent) (USDA-NASS, 2010a). 

Each year, the USDA-Economic Research Service (ERS) updates its ten-year projections of 

supply and utilization for major field crops, including corn, soybeans, and wheat grown in the 

U.S. At present, U.S. corn growers are on track to slightly increase planted corn acreage from 

the current level of 88.2 million acres to 92 million acres by 2020 (USDA-ERS, 2011c). This 

ten-year projection reflects an increased domestic and international demand for U.S. corn, and 

will be enabled by improvements in plant genetics, agronomic practices, and government policy 

on both the national and state level (Claassen and Tegene, 1999; USDA-ERS, 2010e). Arable 

land for increased corn planting acreage will result primarily from a combination of grower 

shifts away from other crops and the minor return of idle farmland, such as Conservation Reserve 

Program (CRP) land, back into corn production (USDA-ERS, 2011c). The CRP program 

encourages the environmental protection of highly erodible, privately owned land through 

voluntary, time-dependent contracts between individual land owners and the USDA. Conditions 

of these contracts and their renewals are dependent on statutory and regulatory provisions built 

into the CRP program (Watson, 1994). In particular, land-use decisions regarding CRP land 

enrollment/reenrollment is strongly influenced by agriculture commodity market forces (e.g., 

crop commodity price) and Federal policy governing land subsidies (as there is a reluctance to 

directly regulate private property) (Claassen and Tegene, 1999; Heisel, 1998; Plantinga et al., 

2001; Secchi et al., 2009). For example, the Food, Conservation, and Energy Act of 2008 has 

already stipulated a reduction in CRP land enrollment from 39.2 million acres to 32 million acres 

in order to provide additional cropland to meet future agricultural demands (Food Conservation 

and Energy Act, 2008). This previously established reduction in CRP land enrollment, combined 

with increased funding for Working-Land Conservation Programs, such as The Environmental 

Quality Incentives Program (EQIP), are already providing farmers economic incentives to 

continue farming arable land in order to boost agricultural production while also encouraging the 

adoption and implementation of a wide range of conservation practices (Food Conservation and 

Energy Act, 2008). 

2.1.2 Agronomic Practices 

2.1.2.1 Conventional and GE Corn Production Systems 

Conventional farming in this document includes any farming system where synthetic pesticides 

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

ranging from farmers who only occasionally use synthetic pesticides and fertilizers to those 

farmers whose harvest depends on regular pesticide and fertilizer inputs. This definition of 

conventional farming also includes the use of GE varieties that no longer subject to the 

regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act. 
8

Growers can choose from a large number of corn hybrids produced from traditional breeding or 

genetic engineering systems. Adoption of GE corn in the U.S. has significantly increased since 

2000 on both the state and national level, with 88 percent of all corn planted in 2010 representing 

a GE variety (Table 1). Additionally, growers can also choose from several different crop 

management options. Though specific details of these management options differ in terms of 

geographic cultivation area and end-use market, general management decisions are commonly 

shared. These include method of tillage, addition of agronomic inputs, and selection of crop 

rotation system. 

Table 1: Adoption of GE corn varieties by major U.S. corn production states, 2000-2010. 

GE Corn Varieties 

(percent of all corn planted) 

State 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 

Illinois 16 22 28 33 36 55 74 80 84 84 86 

Indiana 12 13 16 21 26 40 59 78 79 79 85 

Iowa 32 41 45 54 60 64 78 84 86 86 90 

Kansas 38 43 47 54 63 68 82 90 91 91 92 

Michigan 17 22 35 33 40 44 60 72 75 75 87 

Minnesota 36 44 53 63 66 73 86 88 88 88 93 

Missouri 32 34 42 49 55 59 62 70 77 77 85 

Nebraska 34 46 52 60 69 76 79 86 91 91 93 

North Dakota - - - - 75 83 88 89 93 93 97 

Ohio 11 9 9 13 18 26 41 66 67 67 74 

South Dakota 47 66 75 79 83 86 93 95 96 96 96 

Texas - - - - 72 77 79 78 84 84 88 

Wisconsin 18 26 32 38 46 50 64 75 77 77 86 

Other States 20 27 36 46 44 55 67 74 78 78 86 

U.S. total 26 34 40 47 52 61 73 80 85 85 88 

Source: (USDA-ERS, 2010a; USDA-NASS, 2011a) 

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

for space, water, and nutrients. 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 percent crop residue; reduced tillage 

is associated with 15 to 30 percent crop residue; and conservation tillage, including no-till 

practices requiring herbicide application on the plant residue from the previous season, is 

associated with at least 30 percent crop residue and substantially less soil erosion than other 

tillage practices (EPA, 2009). Conservation tillage has been associated with higher soil moisture 

retention when compared to conventional and reduced tillage methods (Smika and Wicks, 1968). 

Because of its low cost and positive impact on soil quality, conservation tillage is currently and 

widely practiced in the Midwestern U.S. (EPA, 2009). 
9

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

yield (Olson and Sander, 1988). Agronomic inputs include corn fertilizers to supplement 

available nutrients in the soil; pesticides to reduce pest plant, insect, and/or microbial 

populations; and moisture to ensure normal plant growth and development (Cerrato and 

Blackmer, 1990; Hall et al., 1992; Howell et al., 1998; Levine, 1991; Smith and White, 1988). 

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

nitrogen, phosphorus, and potassium is widely practiced in order to maximize corn grain yield 

(Paulson and Babcock, 2010; Sheriff, 2006). In 2005 (the date of the last USDA Agricultural 

Chemical Usage Summary to include corn) nitrogen was applied to 96 percent of corn acreage at 

an average of 138 pounds per acre (lb/acre); phosphate was applied to 81 percent of corn acreage 

at an average rate of 58 lb/acre; and potash was applied at a rate of 84 lb/acre to 65 percent of 

corn acreage (USDA-NASS, 2006). Like fertilizer application, pesticide use for pest control is 

also common in corn. Herbicides were applied to 97 percent of corn acreage in 2005, with 

Atrazine (66 percent), Glyphosate (31 percent), S-metolachlor (23 percent) and Acetochlor (23 

percent) most routinely applied (USDA-NASS, 2006). Additionally, 23 percent of corn-planted 

acreage was treated with insecticides, with the most abundantly applied being Tefluthrin (7 

percent), Cyfluthrin (7 percent), and Tebupirimphos (6 percent) (USDA-NASS, 2006). While 

agricultural herbicide use trends resulting from the utilization of GE technologies are the subject 

of much debate (Benbrook, 2009; Brookes and Barfoot, 2010; Day et al., 1999; FernandezCornejo et al., 2009), it is generally agreed that insecticide use in U.S. crops has decreased since 

the introduction of GE insect-resistant crop varieties (Benbrook, 2009). In 2010, 63 percent of 

total U.S. corn acreage was planted with insect-resistant corn (USDA-ERS, 2010a). 

In major U.S. corn production regions, moisture availability is strongly correlated with grain 

yield. For example, four consecutive days of visible wilting prior to tassel emergence can reduce 

grain yields by 25 percent, while this same duration of stress during silk 

emergence/anthesis/grain fill can cause a 40 to 50 percent yield reduction (Hesterman and Carter, 

1990; McWilliams, 2002). Drought-related reduction in grain yield is mediated through several 

mechanisms, including reduced grain number, an increase in floral asynchrony, and the abortion 

of fertilized kernels during ear development (Westgate et al., 2004). 

Corn generally requires a steady supply of moisture, though the amount required is dependent on 

developmental stage. For example, prior to pollination, corn generally requires 0.1 inches per 

day; during pollination and grain fill, this water requirement increases to a maximum of 0.35 

inches per day (McWilliams, 2002). This moisture demand is met by a combination of natural 

rainfall/stored soil moisture and supplemental irrigation during the growing season (Neild and 

Newman, 1990). In U.S. corn production areas where supplemental irrigation is practiced, light 

and frequent irrigation is superior to heavier, less frequent irrigation involving the same overall 

amount of water (Olson and Sander, 1988). Under conditions of moderate water deficit, corn 

yields can be reduced by approximately 15 percent; crop failure can also result under more 

severe drought conditions (Barker et al., 2005). While conventionally-produced corn hybrids 

have been produced to exhibit increased drought tolerance, the basic water requirements of corn 

have not been overcome. Thus, these drought-tolerant varieties will not likely be grown outside 

of current corn cultivation areas. 

Crop rotation is practiced to increase soil fertility and reduce the proliferation of pests and 

diseases. For example, in a corn-soybean rotation, continuously growing corn for multiple 
10

growing seasons can decrease populations of soybean pests, such as soybean cyst nematode 

(Hoeft et al., 2000). Crops used in rotation with corn vary regionally, but there has been an 

increase in the number of fields that have adopted a corn-to-corn rotation. Decisions about crop 

sequences are guided by many factors, including economic return from differences in input cost, 

yield potential, and commodity prices. Reflecting these agricultural and market forces, the recent 

trend in the adoption of corn-to-corn rotation in conventional and GE production systems has 

been primarily attributed to rising corn prices and increased market demand for corn across all 

consumer sectors (Hart, 2006; Stockton et al., 2007). However, in spite of these market forces, 

the benefits of crop rotation in terms of pest and disease management strategies provide an 

incentive for growers to choose corn-alternative crop rotations and remain one factor among 

many that contribute to overall land-use decisions by individual farmers. 

2.1.2.2 Specialty Corn Production Systems 

While the vast majority of corn grown in the U.S. is grown as grain for animal feed, ethanol, and 

industrial uses, approximately 8 percent of corn grown in the U.S. (2005/06 growing season) is 

specialty corn specified by buyers and end-users of corn (USGC, 2006). Specialty corns include: 

sweet, high oil, nutritionally-enhanced corn varieties, and organically-produced varieties 

(USGC, 2006). Due to premiums offered by end-users and the dramatic adoption by U.S. 

farmers of GE corn varieties, specialty corn products are receiving increased attention as 

potentially profitable alternatives to the products of conventional and GE corn production 

systems (Elbehri, 2007). 

Product differentiation and market segmentation in the specialty corn industry includes 

mechanisms to keep track of the grain (traceability) for Identity Preservation (IP) and quality 

assurance processes (e.g., ISO9001-2000 certification), as well as contracts between growers and 

buyers that specify delivery agreements (Sundstrom et al., 2002). Systems used by specialty 

corn growers and end-users to maintain identity of the production include: 

 Contracts – written agreements detailing responsibilities and duties of both parties 

including premiums for reaching goals and penalties for failing to attain specifications; 

 Tracking and Traceability Systems – correct labeling of all products (planting seeds and 

harvested material) and testing procedures for identifying and detecting acceptability of 

materials; 

 Quality Assurance Processes – oversight on handling procedures, testing of planting 

seeds, and testing of harvested materials to determine acceptability of use and product 

requirements, and assuring testing procedures are appropriate; and 

 Closed-Loop Systems – the end-user supplies the planting seeds and guarantees to 

purchase final products. This may also require that the end-user conduct intermediate 

procedures such as planting, providing oversight during the growing season, harvesting, 

and transportation to processing plant. 

IP systems that have been shown to be successful in the past include seed certification systems 

conducted by members of American Organization of Seed Certifying Agencies (AOSCA) 

(AOSCA, 2009). To maintain the purity of the corn product, this production system is based on 
11

controlling, tracking, and documenting each step from seed production to end use (processing 

plants). 

2.1.2.3 Organic Corn Production Systems 

Organic farming is defined in this document to include any production system that falls under the 

USDA-National Organic Program (NOP) definition of organic farming and is a certified organic 

production system. The NOP is administered by the USDA-Agricultural Marketing Service 

(AMS). Organic farming operations, as described by the USDA-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. Excluded methods, as defined by the USDA-NOP, may include the use of 

synthetic pesticides, fertilizers, and recombinant DNA technology found in GE crops. Organic 

production operations must also develop and maintain an organic production system plan 

approved by their accredited certifying agent. This plan enables the production operation to 

achieve and document compliance with the National Organic Standards, including the 

prohibition on the use of excluded methods. 

Organic certification involves oversight by an accredited, third-party certifying agent of the 

materials and practices used to produce or handle an organic agricultural product (7 CFR 

205.300). This oversight includes an annual review of the certified operation’s organic system 

plan and on-site inspections of the certified operation and its records. Although the National 

Organic Standards prohibit the use of excluded methods (7 CFR 205.272), they do not require 

testing for the presence of excluded methods. Thus, NOP certification is dependent on process 

and not product. With regard to the unintentional presence of GE material in an organic product 

or operation, a recent USDA-AMS Policy Memorandum clarified that the unintentional presence 

of GE material will not affect the status of an organic product or operation when the operation 

has taken reasonable steps to avoid the products of recombinant DNA technology (USDA-AMS, 

2011). However, retailers often require organic and non-GE farmers to verify their harvests 

through various tests (Ruth, 2003). 

In 2007, 93.5 million acres of corn were planted in the U.S., yielding 13 billion bushels of corn 

(USDA-NASS, 2010b). For the same year, USDA-ERS reported that 194,637 acres (0.21 

percent) out of a total 93.5 million acres planted were certified organic (USDA-ERS, 2010d). 

In 2008, Wisconsin, Iowa, Minnesota, Michigan, New York, Texas, and Nebraska each had 

more than 10,000 acres of certified organic corn, totaling approximately 68 percent of all 

certified organic acreage in the U.S. (Table 2) (USDA-ERS, 2010d). Generally, acreage 

increased from 2007 to 2008, although, in some instances, certain states showed a decrease in the 

number of certified organic acres. 
12

Table 2: Certified organic corn acreage by state with more than 1,000 acres of certified 

land in 2007 and 2008. 

State Acreage State Acreage 

2007 2008 2007 2008 

California 1,305 2,765 New Mexico 

2,700 1,552 

Colorado 2,445 3,043 New York 11,909 11,459 

Illinois 7,319 8,739 North Dakota 3,292 4,761 

Indiana 2,414 2,998 Ohio 8,786 8,969 

Iowa 24,944 25,419 Oregon 1,072 1,712 

Kansas 2,067 4,637 Pennsylvania 4,482 5,918 

Maine 1,025 1,237 South Dakota 5,779 5,564 

Maryland 1,009 1,239 Texas 7,710 11,202 

Michigan 12,722 12,663 Virginia 1,286 1,472 

Minnesota 26,849 27,565 Washington 1,970 2,265 

Missouri 7,144 3,765 Wisconsin 27,431 33,619 

Nebraska 12,226 10,568 U.S. Total 170,905 193,136 

Source: “Certified Organic Grains”, Organic Production Data Files (USDA-ERS, 2010d). 

2.2 Physical Environment 

2.2.1 Water Resources 

Corn requires a steady supply of moisture, totaling approximately 4,000 gallons through the 

growing season to produce one bushel of grain (NCGA, 2007). This demand is met by a 

combination of natural rainfall, stored soil moisture from precipitation before the growing 

season, and supplemental irrigation during the growing season (Neild and Newman, 1990). 

Groundwater is the major source for irrigation, used on almost 90 percent of irrigated corn 

acreage in the U.S. (Christensen, 2002). In 2007, 13.0 million U.S. corn acres were irrigated, 

reflecting 15 percent of all corn acres harvested for grain (USDA-NASS, 2007). 

Agricultural non-point source (NPS) pollution is the primary source of discharge pollutants to 

rivers and lakes and a major contributor to groundwater contamination. Management practices 

that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the 

application of pesticides, herbicides, and fertilizers. Agricultural pollutants released by soil 

erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and streams 

when they are carried off of fields by rain or irrigation waters (EPA, 2005). Excess sediment can 

directly affect fish and other wildlife mortality and reduce the amount of light penetration into a 

body of water. Indirectly, soil erosion-mediated sedimentation can increase fertilizer runoff, and 

facilitate algal blooms and oxygen depletion in a body of water (EPA, 2005). 
13

2.2.2 Soil 

Arable land supports a rich and complex community of below ground microorganisms and 

arthropods. The interaction between the below ground community, plant root structure, and 

organic residues in the soil is central to a variety of dynamic soil ecological processes, including 

the decomposition of organic material, subsequent nutrient cycling and release, and the 

concomitant maintenance of soil structure and composition. 

Cultivation of corn directly impacts the qualitative and quantitative attributes of soil. As with 

any agricultural system, land management options, such as crop type, tillage, and pest 

management regime have notably greater effects on the biology of the soil than the type of corn 

cultivated (Griffiths et al., 2007a; Griffiths et al., 2007b). For example, conventional tillage and 

mechanized harvesting machinery may disturb and expose the top soil surface layer, leaving the 

land prone to degradation. In turn, degradation of soil structure and composition may lead to 

decreased water retention, a decrease in soil carbon aggregation and net positive carbon 

sequestration, and increased emission of radiatively-active gases that contribute to the 

greenhouse effect (e.g., carbon dioxide (CO2) and nitrous oxide (N2O)) (EPA, 2010c; Lal and 

Bruce, 1999). Additionally, as previously discussed, land that is prone to degradation is also 

more likely negatively affect water resource quality and communities of organisms dependent on 

those water resources. 

2.2.3 Air Quality 

There are many measures of air quality relevant to agriculture, such as the Clean Air Act (CAA) 

National Ambient Air Quality Standards (NAAQS) criteria pollutants, greenhouse gases 

(GHGs), volatile organic compounds (VOCs), pesticides, odors, and airborne allergens. The 

seven NAAQS criteria pollutants are carbon monoxide (CO), lead, nitrogen dioxide (NO2), 

particulate matter between a nominal 2.5 and 10 micrometers in aerodynamic diameter (PM10), 

particulate matter less than a nominal 2.5 micrometers in aerodynamic diameter (PM2.5), ozone 

(O3), and sulfur dioxide (SO2) (EPA, 2010d). Emissions from crop agriculture can be broken 

down into two main categories  emissions related to working fields, such as dust and equipment 

emissions, and emissions from the soil and plants. 

Agriculture activities (e.g., field preparation, planting, and harvesting) may generate dust plumes 

(PM10 and PM2.5) (Holmén et al., 2006). For example, peak levels of particulate concentrations 

coincide with the peak agricultural harvest season in California’s Central Valley (Giles et al., 

2006). Emissions released from agricultural equipment (e.g., irrigation pumps and tractors) 

include CO, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (EPA, 

2010a). Greenhouse gas (GHG) emissions from agriculture (crops and livestock) are mainly in 

the form of methane and nitrous oxide (EPA, 2010c). Other trace gases from agriculture include 

carbon dioxide and ammonia (Krupa et al., 2006). Atmospheric wet and dry deposition of 

nitrogen, mineral nutrients, and organic compounds to cropping systems can have feedback 

effects on trace gas emissions from fields (Krupa et al., 2006). Agricultural pesticides may also 

enter the atmosphere through volatilization from soil and plant surfaces and through wind erosion 

and can be returned to the surface through precipitation or dry deposition processes (Vogel et al., 

2008). 
14

2.2.4 Climate Change 

Climate change represents a statistical change in global climate conditions, including shifts in the 

frequency of extreme weather, that may be measured across time and space (Cook et al., 2008; 

Karl et al., 2008). Production of agricultural commodities is interrelated with climate change on 

several different levels, with agricultural activities recognized as both direct (e.g., exhaust from 

equipment) and indirect (e.g., agricultural-related soil disturbance) sources of GHG emissions 

(Dale, 1997; EPA, 2010b; Fargione et al., 2008; Gutowski et al., 2008; Piñeiro et al., 2009; 

Rosenzweig and Parry, 1994). Greenhouse gases, including carbon dioxide (CO2), methane 

(CH4), and nitrous oxide (N2O), function as retainers of solar radiation. GHGs are derived from 

agricultural activities, such as combustion of fossil fuels in mechanized farm equipment, fertilizer 

application, and decomposition of agricultural waste products (Aneja et al., 2009; EPA, 2010b). 

The U.S. agricultural sector is identified as the second largest contributor to GHG emissions, 

ranking only behind the energy sector (i.e., electricity production, transportation, and related 

activities) (EPA, 2010b). 

Agricultural crop commodities may also affect dynamic geophysical soil processes, such as 

carbon turnover and sequestration, through tillage and land management practices (Smith and 

Conen, 2004). In general, conservation tillage strategies (including no- and reduced-tillage 

practices) are associated with more stable and increased carbon sequestration due to a net 

reduction in carbon dioxide emissions (Lal and Bruce, 1999; West and Marland, 2002). Recent 

literature, however, suggests that the relationship between conservation tillage and increased 

carbon sequestration require more study, as soil depth level and seasonal sampling bias may have 

inadvertently affected measurements (Angers et al., 1997; Baker et al., 2007; Oorts et al., 2007; 

Potter et al., 1998; Wanniarachchi et al., 1999; West and Marland, 2002). However, the 

relationship between different GHG emissions, such as carbon dioxide and the more potent 

nitrous oxide may influence paradigms related to tillage strategies and global climate change 

(Gregorich et al., 2005). For example, increased nitrous oxide emissions as a result of 

conservation tillage strategies may offset any gains achieved through increased carbon 

sequestration and reduced carbon dioxide emissions. Like the relationship between conservation 

tillage strategies and carbon sequestration, a broad generalization regarding the impact of tillage 

strategy and nitrous oxide emissions is difficult, as numerous factors influence soil nitrification 

cycles, including geographic location, soil structure, moisture, and farm-level management 

practices (including, but not limited to fertilizer and pesticide application) (Almaraz et al., 2009; 

Ball et al., 2008; Campbell, 2003; Del Grosso et al., 2008; Elmi et al., 2003; Farahbakhshazad et 

al., 2008; Grandy et al., 2006; Gregorich et al., 2006; Gregorich et al., 2005; Halvorson et al., 

2008; Linn and Doran, 1984; MacKenzie et al., 1998; Metay et al., 2007; Palma et al., 1997; 

Philippe, 2008; Poirier et al., 2009; Rochette et al., 2008; Ruser et al., 2006; Six et al., 2004; 

Smith and Conen, 2004; Smith et al., 2002; Steinbach and Alvarez, 2006; Tan et al., 2009; Ussiri 

et al., 2009; Venterea et al., 2005). 

Global climate change may also affect agricultural crop production (CCSP, 2008). These 

potential impacts on the agro-environment and individual crops may be direct, including 

changing patterns in precipitation, temperature, and duration of growing season, or may cause 

indirect impacts influencing weed and pest pressure (Rosenzweig et al., 2001; Schmidhuber and 

Tubiello, 2007). The impacts of GE crop varieties on climate change are unclear, though it is 

likely dependent on cropping systems, production practices, geographic distribution of activities, 
15

and individual grower decisions. APHIS will continue to monitor developments that may lead to 

possible changes in the conventional production system likely to result from GE products 

brought to APHIS for a determination of nonregulated status. The potential impact of climate 

change on agricultural output, however, has been examined in more detail. A recent IPCC 

forecast (IPPC, 2007) for aggregate North American impacts on agriculture from climate change 

actually projects yield increases of 5 to 20 percent for this century. The IPCC report notes that 

certain regions of the U.S. will be more heavily impacted because water resources may be 

substantially reduced. While agricultural impacts on existing crops may be significant, North 

American production is expected to adapt with improved cultivars and responsive farm 

management (IPPC, 2007). 

2.3 Animal and Plant Communities and Biodiversity 

2.3.1 Animal Communities 

Corn fields have long been known to be utilized by birds, deer, and various small mammals (e.g., 

raccoons (Procyon lotor), deer mice (Peromyscus maniculatus), meadow voles (Microtus 

pennsylvanicus), and thirteen-lined ground squirrels (Spermophilus tridecemlineatus) for feeding 

and cover. 

Bird species that have been observed in row crop fields include, among others, blackbirds (e.g., 

red-winged blackbirds (Agelaius phoeniceus)), horned larks (Eremophila alpestris), brownheaded cowbirds (Molothrus ater), and vesper sparrows (Pooecetes gramineus) (Best and 

Gionfriddo, 1991). Specific bird species can act as beneficial or detrimental members in the 

agro-environment. For example, red-winged blackbird are often initially attracted to corn fields 

to feed on insect pests, but then also feed on the corn. Studies have shown that red-winged 

blackbirds can destroy more than 360,000 tons of field corn and substantial amounts of sweet 

corn annually (Dolbeer, 1990). Although many birds visit row-crop fields such as corn, numbers 

are low and few nest there, likely due to overlap between nesting phenology and mechanized 

harvest (Johnson, 2000; Patterson and Best, 1996). 

Deer, such as the white-tailed deer (Odocoileus virginianus), find field corn attractive because it 

functions both as food and cover throughout the latter half of the growing season (Vercauteren 

and Hygnstrom, 1993). Deer can significantly damage or completely destroy small corn fields 

that are surrounded by woody or brushy areas; data from the Wisconsin Department of Natural 

Resources show approximately $915,000 in corn damage from white-tailed deer in 2008 (Koele, 

2008). However, deer damage to large corn fields is often limited to a few rows closest to the 

wooded areas (Neilsen, 1995). Raccoon damage to field corn has increased in recent years 

(Beasley and Rhodes Jr., 2008). In northern Indiana, Humberg et al. (2007) attributed 87 percent 

of corn plants damaged across 100 corn fields over two growing seasons to raccoons. The deer 

mouse is the most common small mammal in some corn production regions (Stallman and Best, 

1996; Sterner et al., 2003). Deer mice feed on a wide variety of plant and animal matter, but 

primarily feed on seeds and insects. They are considered beneficial in agro-ecosystems because 

they consume both weed and pest insect species. The meadow vole feeds primarily on fresh 

grass, sedges, and herbs, but also on seeds and grains. Meadow voles also can be considered 

beneficial for their role in the consumption of weeds, but can be an agricultural pest where 

abundant (Smith, 2005). The thirteen-lined ground squirrel feeds primarily on seeds of weeds 

and available crops, such as corn and wheat (Smith, 2005; Sterner et al., 2003). Thirteen-lined 
16

ground squirrels have the potential to damage agricultural crops, although they can also be 

considered beneficial when eating pest insects such as grasshoppers and cutworms. 

Although many of the invertebrate organisms found in corn-producing areas are considered 

pests, such as the corn earworm (Helicoverpa zea), European corn borer (Ostrinia nubilalis), fall 

armyworm (Spodoptera frugiperda), and the corn rootworm (Diabrotica spp.), many others are 

considered beneficial (Hoeft et al., 2000). For example, numerous invertebrates perform 

valuable functions, such as pollinating plants (bees), contributing to the decay of organic matter 

(earthworms), cycling soil nutrients (earthworms), and attacking other pest insects and mites 

(ladybird beetles). 

2.3.2 Plant Communities 

The floral community surrounding a corn field is dependent on geography. In certain areas, corn 

fields can be bordered by other agricultural fields (including those of other corn varieties), 

woodlands, or pasture and grasslands. From an agronomic perspective, the most relevant 

members of a surrounding plant community are those that can behave as weeds. Thus, weed 

pressure is also dependent on geography. Reductions in corn agronomic performance is 

sometimes associated with weed competition for water, nutrients, and light. U.S. corn yields are 

threatened by more than 200 weed species annually (Heap, 2008). Common corn field weeds in 

Indiana includes giant foxtail (Setaria faberi), giant ragweed (Ambrosia trifida), velvetleaf 

(Abutilon theophrasti), common cocklebur (Xanthium strumarium), Canada thistle (Cirsium 

arvense), common lambsquarters (Chenopodium album), Johnsongrass (Sorghum halepense), 

fall panicum (Panicum dichotomiflorum), and marestail (Conyza canadensis) (Childs, 1996). 

Weeds such as giant foxtail (Setaria faberi) and barnyardgrass (Echinochloa crusgalli) have been 

shown to reduce corn yields by up to 14 and 35 percent, respectively (Bosnic and Swanton, 

1997; Fausey et al., 1997). 

Weediness 

In the U.S., corn is not listed as a weed (Crockett, 1977; Holm et al., 1979; Muenscher, 1980). 

Furthermore, corn is grown throughout the world without any report that it is a serious weed or 

that it forms persistent feral populations. Corn is poorly suited to survive without human 

assistance and is not capable of surviving as a weed (Baker, 1965; Galinat, 1988; Keeler, 1989). 

Like many domesticated crops, corn seed from a previous year’s crop can overwinter and 

germinate the following year. For instance, the appearance of corn seedlings in soybean fields 

following a corn crop is a common occurrence. Manual or chemical measures are often applied 

to remove these volunteers, but the plants that are not removed do not typically result in feral 

populations in subsequent years. Corn does not possess the suite of traits that are characteristics 

of successful weeds (Baker, 1965; Keeler, 1989). 

APHIS assessed whether MON87460 is any more likely to become a weed than the isogenic 

nontransgenic corn line or other corn varieties currently under cultivation. The assessment 

encompasses a thorough consideration of the basic biology of corn and an evaluation of the 

unique characteristics of MON87460 evaluated under field conditions, including potential 

weediness traits such as seed dormancy and germination, rate of growth and development, 

flowering, seed dispersal, seed yield, and persistence of free-living populations outside 

cultivation (See Appendix C). The Monsanto Company collected phenotypic and agronomic 
17

field data from field trials conducted at 27 U.S. locations during the 2006 and 2007 growing 

seasons that included diverse agro-environments representative of the major corn-growing areas 

of the upper mid-west in the U.S. Likewise, Monsanto also collected data from four field trials 

from Chile (Monsanto, 2010). In addition, data on abiotic stress tolerance from greenhouse and 

growth chamber assays were used to characterize the extent of stress tolerance imparted by the 

insertion of the cspB gene and determine whether any potential changes enhanced weediness 

potential in MON87460. 

2.3.3 Biodiversity 

Biodiversity is strongly impacted by agricultural practices, including the type of cultivated plant 

and its associated management practices. Species diversity and abundance in corn agroecosystems may differ between conventional, GE, and organic production systems. Relative to 

any natural ecosystem, species abundance and richness will generally be less in intensivelymanaged agro-ecosystems. 

Many studies over the last ten years have investigated the differences in biological diversity and 

abundance between GE and non-GE fields, particularly those GE crops that are resistant to 

insects (e.g., Bt crops) or herbicides (e.g., glyphosate-tolerant or glufosinate-tolerant crops). 

Among the numerous studies, conflicting results are often reported. Different studies have 

demonstrated decreases in biological diversity or abundance due to GE crops engineered to 

accumulate insecticidal proteins or tolerate herbicide application for weed management (Ponsard 

et al., 2002). Alternatively, other studies of GE crops, such as Bt corn, when compared to nonGE crops sprayed with insecticides demonstrate that GE crops do not cause any changes in 

arthropod abundance or diversity (Chen et al., 2008; Pioneer, 2009; Romeis et al., 2006; Torres 

and Ruberson, 2005; Wolfenbarger et al., 2008). Some reports show that GE crops may even 

increase biological diversity in agro-ecosystems (Marvier et al., 2007; Romeis et al., 2006). 

Herbicide-tolerant corn, when compared to non-GE corn production, may not result in changes 

in arthropod abundance and may increase species diversity during different times of the year 

(Brooks et al., 2003; Hawes et al., 2003; Roy et al.). Since biological diversity can be defined 

and measured in many ways, APHIS considers determining the level of biological diversity in 

any crop to be complex and hard to achieve concurrence. Another difficulty with biodiversity 

studies is separating expected impacts from indirect impacts. For example, reductions of 

biological control organisms are seen in some Bt-expressing GE crops, but are caused by 

reduction of the pest host population following transgenic pesticide expression in the GE crop 

plant. 

2.3.4 Gene Flow 

Gene flow is a biological process that facilitates the production of hybrid plants, introgression of 

novel alleles into a population, and evolution of new plant genotypes. Gene flow to and from an 

agro-ecosystem can occur on spatial and temporal scales. In general, plant pollen tends to 

represent the major reproductive propagule that can transverse space, while both seed and 

vegetative propagules tend to promote the movement of alleles across time and space. 

The rate and success of gene flow is dependent on numerous external factors in addition to the 

donor/recipient plant. General external factors related to pollen-mediated gene flow include the 

presence/abundance/distance of sexually-compatible plant species; overlap of flowering 
18

phenology between populations; the method of pollination; the biology and amount of pollen 

produced; and weather conditions, including temperature, wind, and humidity (Mallory-Smith 

and Zapiola, 2008; Rieger et al., 2002). Seed-mediated gene flow also depends on many factors, 

including the absence/presence/magnitude of seed dormancy; contribution and participation in 

various dispersal pathways; and environmental conditions and events. 

Corn is self-compatible and wind-pollinated. Unlike other grass species in the U.S. (Watrud et 

al., 2004; Wipff and Fricker, 2002), there are no native plant species that can be pollinated by 

corn pollen without human intervention (e.g., chromosome doubling or embryo rescue) (Galinat, 

1988; Mangelsdorf, 1974; Russell and Hallauer, 1980). However, teosinte (wild progenitor of 

corn) can sometimes be found as introduced populations in botanical gardens and as feral 

populations of Zea mexicana in Florida, Alabama, Maryland (USDA-NRCS, 2010), and Zea 

perennis in South Carolina (USDA-NRCS, 2011). Feral populations of the closely related and 

sexually compatible subspecies of Z. mays spp. parviglumis have also been described in a single 

county (Miami-Dade) of Florida (Pioneer, 2009). Evidence of introgression of genes from corn 

into U.S. teosinte populations has not been sought but complex mechanisms of incompatibility 

have been described that are barriers to this potentiality (Kermicle and Evans, 2010). 

Corn plants do not produce clonal structures nor can corn plants produce vegetative propagules. 

Therefore, asexual reproduction and gene flow as a result of dispersal of vegetative tissues does 

not occur with corn. 

2.3.4.1 Intraspecies Gene Flow 

Many varieties of corn are cultivated in the U.S. For gene flow to occur between corn varieties, 

flowering of the source and sink populations must overlap, pollen transfer must occur, 

embryo/seeds must develop, and hybrid seed must disperse and establish. Corn is a monoecious, 

out-crossing, wind-pollinated crop that produces abundant, large, and heavy pollen. 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 restricted between 

genetically modified, conventional, and organic corn (Eastham and Sweet, 2002). 

A variety of plant properties, environmental conditions, and imposed conditions can affect 

movement of genes between corn cultivars (see Appendix B for a detailed list). 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 percent genetic purity, 

though higher instances of out-crossing can occur (Ireland et al., 2006). For example, the NOP 

has requirements for organic plans to address pollen flow from GE crops that include 

recommendations for spatial isolation (Krueger, 2007). The Association of Official Seed 

Certifying Agencies (AOSCA) also has information for specialty corn crops, and a protocol for 

growing non-GE corn (AOSCA, 2009). 

Pollen-mediated gene flow and mitigation 

As noted, a primary spatial mechanism to maintain corn genetic purity is isolation distance. 

Although corn pollen is dispersed by wind and gravity, in contrast to the pollen of other grass 

species, corn pollen is much larger (Thomison, 2011). The majority of corn pollen generally 
19

falls within a short distance of the originating corn plant, though under certain atmospheric 

conditions, corn pollen may travel farther (Eastham and Sweet, 2002). A recent paper reviewed 

studies investigating gene flow and cross-fertilization studies in corn grain production fields, and, 

using the data from these studies, recommended 50 meters (m) (approximately 164 feet (ft)) as 

the distance needed to isolate GE corn from non-GE corn (Sanvido et al., 2008). The authors 

limited their analysis to studies that confirmed fertilization in the non-GE corn plants, and 

excluded studies on pollen dispersal that only measured pollen flow, because pollen flow does 

not necessarily result in fertilization (Sanvido et al., 2008). Successful cross-fertilization requires 

many different biological and physical factors, such as synchrony of flowering between corn 

fields, viability of pollen, and presence of physical barriers, and thus pollen dispersal is not 

equivalent to cross fertilization. Sandivo et al. (2008) analyzed existing studies and found that 

the cross-fertilization rate in non-GE corn typically remained below 0.5 percent at this distance. 

This result was validated when large-scale studies were analyzed for cross-fertilization events 

(Henry et al., 2003; Weber et al., 2007). 

An isolation strategy alone may or may not be adequate for limiting gene flow, depending upon 

seed varieties used and local conditions. One study found cross-fertilization to be as high as 2.5 

percent at 660 ft, which is the isolation distance used by AOSCA to isolate corn fields for seed 

production (AOSCA, 2009). One potential reason for the discrepancy between this study and 

many other gene flow studies in corn may be due to the type of corn used in the Jones and 

Brooks study. Jones and Brooks (1950) investigated the appropriate isolation distance for seed 

production in open-pollinated varieties, and not in hybrid varieties. Due the biology of openpollinated varieties, these types of plants may be more receptive to pollen over a longer period of 

time than hybrid corn plants (Sanvido et al., 2008), allowing for a greater chance of pollination 

events. Thus the results from Jones and Brooks (1950) may be an overestimation of crossfertilization potential for hybrid corn plants. Additional properties also may affect pollenmediated gene flow from corn and are listed in Appendix B. 

Seed-mediated gene flow and mitigation 

For gene flow to occur via seeds and result in feral populations of corn, seeds must disperse and 

establish in new habitats. Through thousands of years of selective breeding by humans, corn has 

been extensively modified to depend on human cultivation for survival (Galinat, 1988). Several 

key weedy traits that would contribute to crop escape, traits associated with ferality and 

volunteerism, have been selectively reduced in corn, resulting in a domesticated crop species not 

equipped for survival without management (Gould, 1968). Also, several traits greatly reduce the 

ability of corn to disperse via seeds. Humans have selected corn to produce seeds that do not 

shatter and cannot disperse from the cob, and corn seeds are tightly bound within a protective 

sheath of leaves, or husk (Galinat, 1988). Corn seeds also lack dormancy, preventing easy 

persistence between seasons in fields or in the weed seed bank. While corn grains or cobs left in 

fields after harvest can result in volunteers in the following year, these volunteers are unlikely to 

produce progeny and persisting populations because of the tightly bound nature of the corn seeds 

to the husk. Specific properties affecting seed-mediated gene flow from corn are listed in 

Appendix B. 
20

2.4 Human Health 

2.4.1 Public Health 

In the past 30 years, the public’s consumption of corn-based products has more than doubled 

corn products have risen from 12.9 pounds annually per capita in 1980 to 33 pounds in 2008; and 

corn sweeteners have risen from 35.3 pounds annually per capita in 1980 to 69.2 pounds in 2008 

(USCB, 2011). During the same time period, the share of corn that is genetically engineered has 

risen from zero to 80 percent (USDA-ERS, 2010a). 

Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the 

products they market are safe and properly labeled. Food and feed derived from any GE crop 

must be in compliance with all applicable legal and regulatory requirements. GE organisms for 

food and feed may undergo a voluntary consultation process with the FDA prior to release onto 

the market. Although a voluntary process, applicants who wish to commercialize a GE variety 

that will be included in the food supply invariably complete a consultation with the FDA. In a 

consultation, a developer who intends to commercialize a bioengineered food meets with the 

agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the 

bioengineered food and then submits to FDA a summary of its scientific and regulatory 

assessment of the food; FDA evaluates the submission and responds to the developer by letter. 

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 

genetic engineering (NRC, 2004). GE crops, relative to their conventionally-bred counterparts, 

are often better characterized due to additional rigor in regulatory requirements (König et al., 

2004). The NRC also noted that at the time, no adverse health effects attributed to genetic 

engineering had been documented in the human population. More recently, the NRC stated that 

GE crops have had fewer adverse effects on the environment than non-GE crops (NRC, 2010). 

Reviews on the nutritional quality of GE foods have generally concluded that there are no 

significant nutritional differences in conventional versus GE plants for food or animal feed 

(Faust, 2002; Flachowsky et al., 2005; König et al., 2004). 

2.4.2 Worker Safety 

Agriculture is one of the most hazardous industries for U.S. workers. As a result, Congress 

directed the National Institute of Occupational Safety and Health to develop a program to address 

high-risk issues related to occupational workers. In consideration of the risk of pesticide 

exposure to field workers, EPA revised its Worker Protection Standard (40 CFR Part 170) in 

1992 to further protect field workers from the hazards of pesticide exposure. Furthermore, the 

Occupational Safety and Health Administration require all employers to protect their employees 

from hazards associated with pesticides and herbicides. 

Pesticides, including herbicides, are used on most corn acreage in the U.S., and changes in 

acreage, crops, or farming practices can affect the amounts and types of pesticides used and thus 

the risks to workers. Pesticide registration, however, involves the design of use restrictions that if 

followed have been determined to be protective of worker health. 
21

2.5 Livestock Health 

Approximately 55 to 60 percent of the corn produced in the U.S. is used for livestock (KyCGA, 

2011). As with human consumption of corn, most of the corn used currently for livestock feed is 

GE (USDA-ERS, 2010a). 

Similar to the regulatory control for direct human consumption of corn under the FFDCA, it is 

the responsibility of feed manufacturers to ensure that the products they market are safe and 

properly labeled. Feed derived from GE corn must comply with all applicable legal and 

regulatory requirements, which in turn protects human health. To help ensure compliance, GE 

organisms used for feed may undergo a voluntary consultation process with FDA before release 

onto the market, which provides the applicant with any needed direction regarding the need for 

additional data or analysis, and allows for interagency discussions regarding possible issues. 

2.6 Socioeconomic 

2.6.1 Domestic and Trade Economic Environment 

Domestic demand for corn in the U.S. comes from its domestic use for feed, ethanol production, 

food, and seed, and totaled 11.1 billion bushels in the 2009/10 marketing year (USDA-ERS, 

2011c). Exports added another 2 billion bushels to total U.S. corn use. Demand is satisfied 

almost entirely by domestic supply, with the U.S. being largely a net exporter of corn. The U.S. 

produced 13 billion bushels of corn in the 2009/10 marketing year and corn occupied the most 

acreage of any crop in the country (USDA-ERS, 2011c). In the 2009/10 marketing year, feed 

was approximately 40 percent of U.S. corn production, food, seed, and industrial uses were 

approximately 45 percent, and exports the remaining 15 percent (USDA-ERS, 2011c). Seeds 

constituted approximately 1.7 percent of domestic corn production, with 5.6 percent being used 

for high fructose corn syrup, glucose and dextrose, and corn starch (USDA-ERS, 2010c). 

Corn is grown in the entire continental U.S. Despite this broad cultivation range, most U.S. 

production is centered in the Corn Belt. The Corn Belt includes Iowa, Illinois, Nebraska, and 

Minnesota, and parts of Indiana, South Dakota, Kansas, Ohio, Wisconsin, and Missouri, and 

represents approximately 80 percent of U.S. annual corn production (USDA-NASS, 2010a). 

Corn production requires approximately 20 inches of soil moisture during the growing season to 

achieve maximum yields. Many U.S. corn-producing states have average annual precipitation 

below 20 inches annually. Among those states, those with most non-irrigated acreage of corn 

harvested are North Dakota, Colorado, Montana, New Mexico, and Wyoming. The states with 

the most irrigated acreage of corn harvested are Nebraska, Kansas, Texas, Colorado, and 

Arkansas (USDA, 2009). Figure 2 shows the corn acres harvested for grain in the U.S. that are 

irrigated (USDA-NASS, 2007b). 

 
22

Figure 2. Irrigated corn for grain, harvested acres: 2007. 

 

 Source: 2007 Census publications, Ag Atlas Maps, Crops and Plants (Map 07-M164, USDA-NASS 2007b). 

Table 3 shows the relative importance of farming and corn in the 11 states mentioned above and 

in the U.S. The first column shows the share of state gross domestic product (GDP) generated by 

crop and animal farms. This does not include GDP generated by supporting activities (e.g., for 

soil preparation, harvesting, or post-harvesting), nor does it include transportation activities or 

processing and commercialization of products downstream from farm production. In all listed 

states but Texas, farms generate a higher share of GDP than the U.S. average. The second 

column shows the share of corn in total crop acreage as an indicator of the relative importance of 

corn in crop farming in each state. Given the value of corn as feed, corn also has an important 

role in animal farms. 

Additionally, there is a niche market for non-GE food and feed in the U.S., as evidenced by 

private labeling initiatives such as the Non-GMO Project, that offers third-party product 

verification and labeling for non-GE products (Non-GMO-Project, 2010). There also is a 

growing niche market for organic products in the U.S. Sales of organic products have been 

growing quickly, having grown from $1 billion in 1990 to $24.8 billion in 2009, representing a 

5.1 percent between 2008 and 2009 (OTA, 2010). However, in the case of organic corn 

production, there is some evidence that supply might be lagging behind demand (Greene et al., 

2009). To satisfy the demand for either organic or non-GE corn, producers have had to adopt 

specific production practices to maintain and prevent the presence of excluded methods as 

dictated by the USDA-NOP. To offset the increase in investment related to these more extensive 

practices, premiums are often paid for non-GE or organic corn. For example, in 2007, 
23

conventional corn averaged $4.19/bushel, whereas organic corn averaged $7.08/bushel (Pioneer, 

2009). 

 Table 3: Relative importance of farms and corn in local economies. 

Area 

Share (percent) of Farms in 

Total Gross Domestic 

Product (2007)a

Share (percent) of Corn in 

Total 

Crop Acreage (2010)b

California 1.24 14.30 

Colorado 1.05 21.69 

Kansas 3.00 20.89 

Minnesota 2.12 37.72 

Montana 3.89 24.03 

Nebraska 6.93 46.07 

New Mexico 1.72 46.07 

North Dakota 10.29 9.43 

South Dakota 9.03 28.16 

Texas 0.79 10.07 

Wyoming 1.07 5.41 

United States 1.00 27.55 

 Sources: (a) Bureau of Economic Analysis, Gross Domestic Product by State, Crop and Animal Production 

(NAICS 111 and 112); (b) National Agriculture Statistics Service, Acreage, Area Planted for All Purposes.

The U.S. is the largest world exporter of corn. Trade in feed for livestock has been a driver of 

trade in corn (USDA-ERS, 2011c). Japan is the world’s largest corn importer, typically followed 

by South Korea, Mexico, Egypt, and Taiwan (USDA-FAS, 2010b). During the last half decade, 

the U.S. share of world corn exports averaged 60 percent, the second largest exporter being 

Argentina (USDA-ERS, 2011c). 

The primary U.S. corn export destinations are also the largest world importers of corn and do not 

seem to have major barriers for importing GE products. In Japan there are no restrictions for 

import of GE varieties that have been approved for commercialization in Japan. In the case of 

genetically engineered varieties not yet approved in Japan, a 1 percent presence in feed is still 

allowed, as long as it has been approved by an exporting country with safety assessments 

equivalent to Japan’s. There is no restriction after approval. In Japan, labeling is mandatory for 

GE food when the GE content can be detected and if the GE ingredient is one of the first three 

ingredients of a product and accounts for more than 5 percent of its total weight (Greuere, 2006). 

Mexico imports and consumes regularly existing varieties of GE corn (USDA-FAS, 2008a). 

South Korea has similar approval processes as Japan and requires labeling for GE animal feed 

(USDA-FAS, 2008b). Taiwan requires labeling for products containing more than 5 percent GE 

content (USDA-FAS, 2008c). Egypt is a large consumer of GE crops, including corn, soybeans, 

and vegetable oils (USDA-FAS, 2006). 
24

Data on trade in organic corn is not readily available but given that U.S. corn imports are 

relatively small and that U.S. organic corn production is a small share of the total, trade in 

organic corn is likely to be a very small share of the total corn trade. 

The affected trade economic environment is defined as those countries with which the U.S. 

engages in corn feed, seed and food trade. Therefore, the trade economic environment most 

likely affected by a determination of nonregulated status of MON87460 would be those countries 

who import corn feed, seed and food. 

The affected domestic environment is defined as any land in the U.S. that is currently producing 

crops that could incorporate a corn rotation, as well as land that could be converted from inactive 

cropland to active cropland, and land currently in the CRP that could be removed from the 

program and farmed. 
25

3 ALTERNATIVES 

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of MON87460 corn. To respond favorably to a petition for nonregulated 

status, APHIS must determine that MON87460 is unlikely to pose a plant pest risk. Based on its 

PPRA (USDA-APHIS, 2010) APHIS has concluded that MON87460 is unlikely to pose a plant 

pest risk. Therefore APHIS must determine that MON87460 is no longer subject to 7 CFR part 

340 or the plant pest provisions of the Plant Protection Act. 

Two alternatives will be evaluated in this EA: (1) no action and (2) determination of 

nonregulated status of MON87460. APHIS has assessed the potential for environmental impacts 

for each alternative in the Environmental Consequences section. 

3.1 No Action Alternative: Continuation as a Regulated Article 

Under the No Action Alternative, APHIS would deny the petition. MON87460 and progeny 

derived from MON87460 would continue to be regulated articles under the regulations at 7 CFR 

Part 340. Permits issued or notifications acknowledged by APHIS would still be required for 

introductions of MON87460 and measures to ensure physical and reproductive confinement 

would continue to be implemented. APHIS might choose this alternative if there were 

insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of 

MON87460. 

This alternative is not the Preferred Alternative because APHIS has concluded through a PPRA 

(USDA-APHIS, 2010) that MON87460 is unlikely to pose a plant pest risk. Choosing this 

alternative would not satisfy the purpose and need of making a determination of plant pest risk 

status and responding to the petition for nonregulated status. 

3.2 Preferred Alternative: Determination that MON87460 corn is No Longer a Regulated 

Article 

Under this alternative, MON87460 and progeny derived from them would no longer be regulated 

articles under the regulations at 7 CFR Part 340. MON87460 is unlikely to pose a plant pest risk 

(USDA-APHIS, 2010). Permits issued or notifications acknowledged by APHIS would no 

longer be required for introductions of MON87460 and progeny derived from this event. This 

alternative best meets the purpose and need to respond appropriately to a petition for 

nonregulated status based on the requirements in 7 CFR part 340 and the agency’s authority 

under the plant pest provisions of the Plant Protection Act. Because the agency has concluded 

that MON87460 is unlikely to pose a plant pest risk, a determination of nonregulated status of 

MON87460 is a response that is consistent with the plant pest provisions of the PPA, the 

regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the 

Coordinated Framework. 

Under this alternative, growers may have future access to MON87460 and progeny derived from 

this event if the developer decides to commercialize MON87460. 
26

3.3 Alternatives Considered but Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for MON87460. The agency 

evaluated these alternatives, in light of the agency's authority under the plant pest provisions of 

the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental 

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

MON87460. Based on this evaluation, APHIS rejected several alternatives. These alternatives 

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

3.3.1 Prohibit Any MON87460 from Being Released 

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

marketplace, APHIS considered prohibiting the release of MON87460, including denying any 

permits associated with the field testing. APHIS determined that this alternative is not 

appropriate given that APHIS has concluded that MON87460 is unlikely to pose a plant pest risk 

(USDA-APHIS, 2010). 

In enacting the Plant Protection Act, Congress found that 

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

under [the Plant Protection Act] shall be based on sound science... § 402(4). 

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

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

implementation of policies for oversight of emerging technologies (such as genetic engineering) 

at the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563 and, consistent with that Executive Order, the following principle, among others, to 

the extent permitted by law, when regulating emerging technologies: 

“[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandates 

of each agency” 

Based on our Plant Pest Risk Assessment (USDA-APHIS, 2010) and the scientific data 

evaluated therein, APHIS concluded that MON87460 is unlikely to pose a plant pest risk. 

Accordingly, there is no basis in science for prohibiting the release of MON87460. 

3.3.2 Approve the Petition in Part 

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

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

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

has concluded that MON87460 is unlikely to pose a plant pest risk, there is no regulatory basis 

under the plant pest provisions of the Plant Protection Act for considering approval of the petition 

only in part. 
27

3.3.3 Isolation Distance Between MON87460 and Non-GE Corn Production and 

Geographic Restrictions 

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

considered requiring an isolation distance separating MON87460 from conventional or specialty 

corn production. However, because APHIS has concluded that MON87460 is unlikely to pose a 

plant pest risk (USDA-APHIS, 2010), an alternative based on requiring isolation distances would 

be inconsistent with the statutory authority under the plant pest provisions of the Plant Protection 

Act and regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production of MON87460 based on the 

location of production of non-GE corn in organic production systems or production systems for 

GE-sensitive markets in response to public concerns regarding possible gene movement between 

GE and non-GE plants. However, as presented in APHIS’ PPRA for MON87460, there are no 

geographic differences associated with any identifiable plant pest risks for MON87460 (USDAAPHIS, 2010). This alternative was rejected and not analyzed in detail because APHIS has 

concluded that MON87460 does not pose a plant pest risk, and will not exhibit a greater plant 

pest risk in any geographically restricted area. Therefore, such an alternative would not be 

consistent with APHIS’ statutory authority under the plant pest provisions of the Plant Protection 

Act and regulations in Part 340 and the biotechnology regulatory policies embodied in the 

Coordinated Framework. 

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

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

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

provisions of the Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. 

However, individuals might choose on their own to geographically isolate their non-GE corn 

productions systems from MON87460 or to use isolation distances and other management 

practices to minimize gene movement between corn fields. Information to assist growers in 

making informed management decisions for MON87460 is available from AOSCA (AOSCA 

2004). 

3.3.4 Requirement of Testing for MON87460 

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

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

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

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

implement and maintain. Additionally, because MON87460 does not pose a plant pest risk 

(USDA-APHIS, 2010), the imposition of any type of testing requirements is inconsistent with the 

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

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for MON87460 would not meet APHIS’ purpose and need to 

respond appropriately to the petition in accordance with its regulatory authorities. 
28

3.4 Comparison of Alternatives 

Table 4 presents a summary of the potential impacts associated with selection of the alternatives 

evaluated in this EA. The impact assessment is presented in Section 4 of this EA. 

Table 4: 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 2010) 

Management Practices 

Acreage and Areas of Corn 

Production Unchanged Minimal 

Cropping practices Unchanged Unchanged 

Pesticide use Unchanged Unchanged 

Seed Corn Production Unchanged Unchanged 

Organic Farming Unchanged Unchanged 

Impact to Specialty Corn Unchanged Unchanged 

Environment 

Water use Unchanged Unchanged 

Soil Unchanged Unchanged

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Animals Unchanged Unchanged 

Plants Unchanged Unchanged 

Biological Diversity Unchanged Unchanged 

Gene Flow Unchanged Minimal 

Human and Animal Health

Risk to Human Health Unchanged Unchanged 

Risk to Worker Safety Unchanged Unchanged 

Risk to Animal Feed Unchanged Unchanged 

Socioeconomic 

Domestic Economic 

Environment Unchanged Unchanged 

Trade Economic 

Environment Unchanged Unchanged 

Social Environment Unchanged Unchanged 

Other U.S Regulatory 

Approvals 

FDA completed 

consultations

FDA completed 

consultations

Compliance with Other Laws

CWA, CAA, EOs Fully compliant Fully compliant 

 *Unchanged – no significant change expected. 

 *Minimal – possibly small changes but no significant differences. 
29

4 ENVIRONMENTAL CONSEQUENCES 

This analysis of potential environmental consequences addresses the potential impact to the 

human environment from the alternatives analyzed in this EA, namely taking no action and a 

determination by the agency that MON87460 does not pose a plant pest risk and therefore should 

no longer be regulated under 7 CFR 340. Potential environmental impacts from the No Action 

Alternative and the Preferred Alternative for MON87460 are described in detail throughout this 

section. A cumulative impacts analysis is presented in Chapter 5. Certain aspects of this product 

and its cultivation would be no different between the alternatives: those are described below. 

4.1 Scope of Environmental Analysis 

The scope includes any land in the U.S. currently producing corn, any land that is currently 

producing crops that could incorporate a corn rotation, as well as land that could be converted 

from inactive cropland to active cropland, and land currently in the Conservation Reserve 

Program (CRP) that could be removed from the program and farmed. Conversion of grassland, 

forest, or other land types to cropland as a result of a determination of nonregulated status of 

MON87460 would be less likely because these types of conversions have not been notable 

contributors to cropland over the past 18 years; therefore, APHIS does not consider them to be 

part of the affected environment in this EA. Furthermore, as described below, MON87460 is 

unlikely to significantly increase future corn acreage beyond USDA-ERS projected expansion in 

irrigated U.S. corn production regions. The MON87460 trait is intended to increase grain yield 

security under conditions of moderate water stress. Minimum moisture requirements are similar 

between MON87460 and conventional corn and therefore MON87460 is not anticipated to 

expand corn acreage into areas not currently used for corn production. 

To determine areas of corn production, APHIS used data from the National Agricultural 

Statistics Service (NASS) 2007 Census of Agriculture to determine where corn is produced in 

the United States (USDA, 2009). Corn grain was commercially produced in all states except 

Alaska. 

4.2 Other Assumptions 

The environmental consequences of the different alternatives described above will be analyzed 

under the assumption that farmers, who produce conventional corn, MON87460, or produce corn 

using organic methods, are using reasonable, commonly accepted best management practices for 

their chosen system and varieties during agricultural corn production. However, APHIS 

recognizes that not all farmers follow these best management practices for corn. Thus, the 

analyses of the environmental affects will also include the assumption that some farmers do not 

follow these best management practices. 

The environmental consequences will be discussed under the context of the MON87460 

phenotype presented in the Monsanto 87460 Petition for Determination of Nonregulated Status. 

In summary, MON87460 does not exhibit improved grain yield relative to the near-isogenic 

control corn variety when subject to well-watered conditions. When other indicators of 

MON87460 agronomic performance are compared to a variety of regionally-adapted corn 

reference hybrids and the near-isogenic control variety, MON87460 neither significantly nor 

consistently performs beyond the observed range of variation, further reinforcing the lack of 
30

increased agronomic performance in MON87460 under well-watered conditions (Monsanto, 

2010). 

When subject to water-limited conditions (<50 percent field capacity), MON87460 displays 

significantly less yield loss relative to the near-isogenic control corn variety. However, other 

measures of the MON87460 phenotype do not significantly deviate from the range of values 

produced by the near-isogenic control or regionally-adapted corn reference hybrids. Combined 

with data demonstrating no significant differences between MON87460 or its control corn 

variety in rate of soil moisture depletion, root:shoot ratio, and cold, heat, and salt stresses, the 

quantified agronomic attributes of MON87460 under water-limited conditions confirms its single 

and predicted phenotype (Monsanto, 2010). These data provide multiple lines of evidence 

indicating that CSPB protein modulates the plant drought response through increased 

photosynthetic efficiency and does not provide an absolute increase in the rate of soil water 

depletion or improved fitness outside the agricultural environment (APHIS, 2011). 

4.3 Agricultural Production of Corn 

4.3.1 Current Acreage and U.S. Cultivation Range 

USDA-APHIS is tasked with protecting the health and value of American agriculture and natural 

resources. Continued regulation of genetically engineered organisms and encouragement of best 

management practices, regardless of farmer decision to cultivate GE or non-GE crop varieties, 

represents two central, practical methods to maintain and improve U.S. agricultural productivity. 

At present, U.S. farmers are projected to increase planted corn acreage from approximately 86.5 

million acres in 2009/10 to 92 million acres in 2020/21 (USDA-ERS, 2011c). The Midwest (~65 

percent) and the Great Plains (~26 percent) represent the major corn-producing regions of the 

U.S. GE corn varieties represent a progressively increasing proportion of total U.S. corn planted, 

ranging from a low of 25 percent in 2000 to 88 percent in 2010 (USDA-ERS, 2010a; USDANASS, 2011a). While the majority of currently commercialized GE corn varieties represent 

either herbicide-tolerant (e.g., glyphosate-, glufosinate-tolerant or other herbicide) or insect 

resistant (i.e., Cry protein expression) varieties, an increasing proportion are varieties with 

multiple stacked traits (i.e., herbicide-tolerant and insect-resistant) (USDA-ERS, 2010a). 

During the 2009/2010 market year, approximately 13.1 billion bushels of corn were harvested in 

the U.S. (USDA-NASS, 2010b). In terms of domestic use, animal feed/residuals and biofuel 

production utilized the majority of produced corn (39 and 35 percent, respectively), whereas 

lesser amounts were used for exportation to foreign markets (15 percent), ending stock seed (13 

percent), food and industrial purposes (10 percent), and seed stock for hybrid seed production 

(0.17 percent) (USDA-NASS, 2010a). 

4.3.1.1 No Action Alternative: Current Acreage and U.S. Cultivation Range 

Under the No Action Alternative, MON87460 and its progeny would remain subject to the 

regulatory requirements of 7 CFR part 340. Existing trends related to the cultivation and 

proportion of crop acreage planted with GE corn varieties are expected to continue, 

incrementally increasing due to broad domestic adoption of commercially-available GE corn 

varieties (USDA-ERS, 2010a, 2011c). With respect to corn cultivation range, corn will continue 
31

to be commercially cultivated in 49 U.S. states, with the majority of production centered in the 

Midwestern U.S. Corn Belt states. 

External market forces across all consumer sectors are anticipated to continue dictating increases 

in corn production under the No Action Alternative. Increased demand for animal feed in the 

livestock industry and favorable net returns for corn ethanol production is likely to sustain this 

growing demand for U.S. corn. In response to these domestic and international market forces, 

U.S. farmers are planting additional corn acreage primarily at the expense of other crops and 

agricultural commodities (e.g., wheat, soybean, and hay), with net corn acreage projected to 

increase to 92 million acres in 2020 from 88 million planted acres in 2010 (USDA-ERS, 2011a, 

2011c). Additionally, under the No Action Alternative, 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, as stipulated in the Food, 

Conservation, and Energy Act of 2008, a net reduction in CRP land enrollment from 39.2 to 32 

million acres in combination with increased funding for Working-Land Conservation Programs 

(e.g., EQIP), represents two Federal policy tools to increase the amount of arable land for 

agricultural production while also encouraging farmers to adopt and implement environmentallyfriendly practices to maintain agricultural productivity (Food Conservation and Energy Act, 

2008). 

External market forces leading to a growing demand for U.S. corn production, reactive 

government policy designed to increase domestic production of agricultural commodities while 

maintaining the productivity of arable land, and responsive individual land-use decisions to meet 

corn production targets by primarily implementing acreage shifts away from other agricultural 

commodities (e.g., wheat, soybean, and hay) reflect economic conditions and trends that have 

occurred independently of the regulatory status of MON87460. Thus, under the No Action 

Alternative, there is no reason to assume that these market conditions and trends will not 

continue. 

4.3.1.2 Preferred Alternative: Current Acreage and U.S. Cultivation Range 

Under the Preferred Alternative, MON87460 would no longer be subject to the regulatory 

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Due to 

previous trends regarding domestic GE corn adoption (USDA-ERS, 2010a), a determination of 

nonregulated status of MON87460 is unlikely to significantly impact this trend due to the current 

availability of numerous GE corn hybrid varieties. 

As previously discussed, both external market forces and government policies have affected 

domestic land-use decisions on the farm level, eventually leading to corn production increases to 

meet growing domestic and international demand for U.S. corn (Chapter 4.3.1.1). Increasing 

domestic corn production can be accomplished by improving efficiency of grain production per 

acre or by increasing the amount of corn cultivation acreage. MON87460 produces a reduced 

yield loss phenotype under conditions of moderate water stress. Under the Preferred Alternative, 

MON87460 may permit farmers to improve grain yield efficiency in areas subject to drought, 

such as the targeted dryland Great Plains Region of corn production. Under this same Preferred 

Alternative, MON87460 is unlikely to significantly expand corn cultivation acreage into novel 

areas or beyond projected values based on physiology of the plant and existing agricultural and 

corn production trends. 
32

In general, MON87460 is designed to provide increased yield security in current corn-producing 

areas that are subject to moderate drought stress. As indicated in data presented by the Monsanto 

Company and the APHIS PPRA of MON87460, the MON87460 trait only confers a reduced 

yield-loss phenotype under water-limited conditions. When subject to water-sufficient 

conditions, MON87460 displays similar measures of growth, development, and agronomic 

performance compared to conventional corn (USDA-APHIS, 2010). Additionally, MON87460 

does not possess traits, such as increased water uptake or increased abiotic stress tolerances (e.g., 

salt, cold, and heat tolerances), that increases its likelihood of establishment in non-agricultural 

areas (USDA-APHIS, 2010). Minimum moisture requirements are similar between MON87460 

and conventional corn. When grown in water-limited field and greenhouse conditions, 

MON87460 exhibits classic drought sensitivity symptoms, including reductions in plant height, 

ear height, seedling vigor, and expected changes in chlorophyll content and leaf roll (USDAAPHIS, 2010). The magnitude of these drought-induced changes in MON87460 is similar to that 

of water-limited conventional corn, with increasing water deficit producing more severe 

developmental symptoms. Collectively, these data provide strong evidence that the negative 

effects of abiotic stress in MON87460 are not eliminated and demonstrate that the cultivation 

range of MON87460 is limited to arable land, similar to that of currently-available corn varieties. 

Despite sharing a cultivation range with commercially-available corn varieties, however, 

MON87460 does not provide improved agronomic performance relative to conventional corn 

when subject to water-sufficient conditions (Monsanto, 2010). Consequently, MON87460 is 

unlikely to be adopted in geographic areas that receive sufficient precipitation (> 30 inches) to 

routinely support high levels of corn production due to an absence of grower benefit (Figure 3). 

These non-irrigated geographic regions, such as the Midwestern Corn Belt, account for 

approximately 85 percent of U.S. corn production and does not represent the intended area of 

introduction, as described elsewhere in this EA and the Monsanto petition (Monsanto, 2010; 

USDA-NASS, 2007, 2010b). 

Figure 3. Average values for U.S. corn harvest and annual precipitation (1971-2000). 

Source: Data derived from the PRISM climate group database (http://www.prism.oregonstate.edu/) and USDA-NASS (USDANASS, 2007). 
33

Existing and projected agricultural trends also provide evidence that MON87460 will not directly 

cause an expansion of corn acreage. As previously discussed in Chapter 2.1.1 and Chapter 

4.3.1.1 of this EA, domestic corn acreage is projected to increase from 88 million acres in 2010 

to 92 million acres in 2020 (USDA-ERS, 2010e, 2011c). This projection reflects recent demand 

for corn grain and encompasses previous observation that any increase in corn acreage is 

primarily taken at the expense of other crops, such as wheat, soybean, and hay (Table 5) (USDAERS, 2011a, 2011c). Additionally, this projection also takes into consideration government 

policies, such as net reductions to CRP land enrollment and an increase in funding for WorkLand Conservation Programs (Food Conservation and Energy Act, 2008), that were previously 

implemented to retain arable land in agricultural productivity. Despite numerous potential 

sources of land, recent data indicates that the overwhelming majority of corn and soybean farms 

(98 percent) are increasing corn acreage through crop shifting and not expansion into 

conservation land (USDA-ERS, 2011a). The current economic outlook for corn demand, 

reactive government policy to address this demand for U.S. agricultural production, and 

responsive crop-shifting by U.S. farmers to increase corn acreage was driven by external market 

forces and not the presence of any particular biotechnology-derived corn variety. 

Table 5. Acreage for major field crops and Conservation Reserve Program (CRP) 

assumptions, long-term projections (USDA-ERS, 2011c). 

Planted Acreage (million acres) 

 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 

Planted acreage, eight major crops 

Corn 86.5 88.2 92.0 91.5 91.0 90.5 90.5 90.5 91 91.5 92.0 92.0 

Sorghum 6.6 5.4 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 

Barley 3.6 2.9 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.2 

Oats 3.4 3.1 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 

Wheat 59.2 53.6 57.0 55.5 54.5 53.0 52.0 51.5 51.5 51.5 51.0 51.0 

Rice 3.1 3.6 3.3 3.2 3.2 3.2 3.3 3.3 3.3 3.3 3.3 3.3 

Upland 

Cotton 9.0 10.8 12.8 12.5 12.2 12.0 11.9 11.8 11.8 11.7 11.7 11.6 

Soybeans 77.5 77.7 78.0 78.3 78.5 79.0 79.5 79.5 79.5 79.5 79.5 79.5 

Total 248.9 245.3 255.3 253.2 251.1 249.9 248.9 248.8 249.3 249.7 249.7 249.6 

CRP acreage assumptions 

Total CRP 33.7 31.4 31.9 31.9 31.9 31.9 31.9 32.0 31.9 31.9 31.9 31.9 

Total plus 

CRP 282.6 276.7 287.2 285.0 283.0 281.9 280.8 280.8 281.2 281.6 281.6 281.5 

Additionally, it is prudent to acknowledge that the reduced yield-loss phenotype of MON 87360 

does not exceed the natural variation observed in regionally-adapted varieties of conventional 

corn (representing different genetic backgrounds) (Monsanto, 2010). Thus, equally drought 

resistant corn varieties produced through conventional breeding techniques are readily available 

and may be cultivated in lieu of MON87460 under the Preferred Alternative. However, despite 

the presence of these comparable corn varieties, crop shifts away from other crops (i.e., wheat, 

soybean, and hay) remain the primary sources of land for additional corn acreage and not 
34

expansion of cultivation into land not managed for agricultural productivity (e.g., CRP acreage). 

This is best detailed in recent data from the Agricultural Resource Management Survey, where 

farm-level production practices and operator financial statuses are collected. Following a period 

of significant increases in corn acreage (2006 – 2007), only 2 percent of corn and soybean farms 

returned CRP acreage back into agricultural production in 2008, providing farm-level evidence 

that crop-shifts by farmers are supplying the majority of land to support increased corn 

production (USDA-ERS, 2011a). 

In summary, under the Preferred Alternative, MON87460 may provide an additional tool for 

U.S. farmers to increase corn grain production efficiency in areas subject to water stress, such as 

the western Dryland Great Plains corn production regions. However, MON87460 is unlikely to 

directly expand corn acreage under the Preferred Alternative because: 1) it is unlikely to be 

adopted in the majority of corn production regions due to an absence of grower benefit; 2) it is 

unlikely to permit corn cultivation in novel areas not previously managed for economicallyviable corn production due to similarities in growth, development, and other aspects of 

physiology with currently-available corn varieties; and 3) it is unlikely to affect current market 

forces and responsive government policy that are already enabling previous and projected corn 

acreage trends. These three factors are made even more poignant when one considers that the 

reduced yield-loss phenotype of MON87460 does not exceed the natural variation observed in 

currently-available corn varieties (Monsanto, 2010; USDA-APHIS, 2010). Thus, equally 

drought resistant varieties produced through conventional breeding techniques are readily 

available in irrigated corn production regions. Despite the availability of comparable corn 

varieties in U.S. markets, however, drought tolerance of the magnitude observed in MON87460 

has not been described as a significant factor influencing market conditions, government policy, 

or observed crop shifts on U.S. farms. 

4.3.2 Cropping Practices 

Corn is an extensively managed crop plant, requiring significant management considerations 

regarding tillage, agricultural inputs, and rotation strategy. Decisions concerning corn agronomic 

practice are dependent on grower want and need, and ultimately reflective of external factors 

including geography, weed and disease pressure, economics of management of yield, and 

production system [rotation] flexibility (Giannessi, 2005; Olson and Sander, 1988). For 

example, corn intended for grain is likely to require less tillage and frequency of 

herbicide/pesticide application relative to seed corn, due to the increased vigor and increased 

resistance to pest and disease of hybrid corn varieties relative to inbred corn lines. Consequently, 

choice of management practice often dictates marketability of a corn product, with certain 

agricultural consumer sectors stipulating requirements and restrictions regarding corn production 

methods. 

Of the numerous agricultural inputs required for corn grain production, moisture readily impacts 

growth and yield. Inadequate moisture at any stage of development is detrimental to the plant, 

though water deficit during grain fill is most strongly correlated with reduced kernel number and 

weight. For example, four consecutive days of visible wilting prior to tassel development or 

anthesis can reduce grain yields by 25 percent (Hesterman and Carter, 1990). In contrast to 

water stress impacts during vegetative growth, subsequent irrigation after water-deficient 

conditions cannot mitigate the negative impacts of drought on corn productivity and grain yield. 
35

4.3.2.1 No Action Alternative: Cropping Practices 

Under the No Action Alternative, MON87460 will continue to be regulated, and corn production 

will continue as currently practiced. Corn will continue to be cultivated under a variety of 

management strategies and sold to a variety of markets. Maintaining the regulated status of 

MON87460 under the No Action Alternative will not impact number of corn varieties available 

for growers, a large number estimated between 1000 (Pioneer, 2008) and 4000 (Monsanto, 

2010). Widespread adoption of GE corn will continue in the U.S., easily accounting for the 

majority of corn produced. 

Current corn management practices are likely to continue under the No Action Alternative. 

Growers make choices to use 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 (Olson and Sander, 1988; Paulson and Babcock, 2010). Notill production of corn will continue to increase under the No Action Alternative, effectively 

mitigating the negative impacts of conventional tillage and associated soil erosion (Fawcett and 

Caruana, 2001). Additionally, agronomic practices involving the application of external inputs, 

such as fertilizer, herbicide, pesticide, and moisture, will remain as it is practiced today. As an 

example of the pesticides used during the production of field corn, the Pesticide Action Network 

has an online database, including a detailed description of all the pesticides used in corn 

agriculture in California (Kegley et al., 2010). It lists the top 50 pesticides (e.g., herbicides, 

insecticides, fungicides) used in California corn production. Any effects due to crop rotation, 

tillage and pesticide use in the agricultural production of seed corn and commercial corn will 

remain the same under the No Action Alternative. Rotation strategies for corn will continue as 

practiced today, with market demand strongly influencing corn rotation practices. 

4.3.2.2 Preferred Alternative: Cropping Practices 

Under the Preferred Alternative, a determination of nonregulated status of MON87460 is 

unlikely to significantly impact cropping practices in non-irrigated corn production regions, as 

these regions already receive sufficient precipitation to limit adoption. These corn cropping 

practices include tillage choices, type and frequency of agricultural inputs, and crop rotation 

strategies. Consequently, corn cropping practices in these regions are unlikely to be significantly 

impacted by MON87460 due to the low likelihood of adoption. 

A determination of nonregulated status of MON87460 and adoption in target regions, including 

the western dryland Great Plains and similar areas subject to frequent and moderate drought 

stresses, is also unlikely to significantly impact corn cropping practices. MON87460 exhibits 

similar agronomic and growth characteristics to conventional corn, with the exception of reduced 

grain yield loss under water-limiting conditions. Consequently, it is not anticipated that 

MON87460 will significantly differ from conventional corn in responding to fertilizer or 

moisture application. In particular, MON87460 displays similar soil moisture depletion rates and 

physiological responses to water-limiting conditions as conventional corn, strongly suggesting 

that irrigation practices for optimal grain yield between MON87460 and conventionallyproduced drought tolerant corn varieties will not differ. With regard to cropping practices in 

regions targeted by MON87460, many management strategies are already focused on land 

management practices that increase water retention characteristics of the soil (reduced till and notill strategies) and appropriate management practices that reflect the cultivated crop (adapted 
36

cultivars and weed control methods). These strategies are available and already employed by 

farmers regardless of production method. Thus, a determination of nonregulated status of 

MON87460 is unlikely to affect the agronomic practices, as it encourages adoption of 

management practices related to fertilization and irrigation already in place by corn farmers. 

Additionally, MON87460 is not expected to alter corn rotation strategies. Recent trends in crop 

rotation strategies already favor corn and are most strongly influenced by market forces and 

government policy; likewise, these trends are often independent of available corn varieties (GE, 

conventional, or organic) at that time (Wu and Brorsen, 1995). This is best demonstrated by the 

sharp increase in corn acreage between 2006 and 2007, paralleling increases in corn price and 

demand (USDA-NASS, 2010b). 

MON87460 is designed to constitutively express the E. coli cspB RNA chaperone. No pesticide 

(e.g., glyphosate tolerance or Bt protein production) traits are co-engineered into the MON87460 

event. Despite the absence of herbicide-tolerant or insect-resistant traits in MON87460, pesticide 

use is not anticipated to change existing trends following its adoption in irrigated corn production 

regions. While agricultural trends in total pesticide use is currently debated (Benbrook, 2009; 

Fernandez-Cornejo et al., 2009), adoption rates of GE herbicide-tolerant or pesticide-resistant 

corn varieties in select western dryland Great Plains states that participate in the USDA-ERS 

Corn Estimating Program (Table 6) indicate that substantial corn acreage is subject to regular 

pesticide application. Introduction of herbicide-tolerant corn varieties, in particular glyphosatetolerant corn, has not significantly affected corn acreage managed with total herbicide application 

(Figure 4). However, MON87460 may facilitate a shift in specific herbicide product use. While 

use trends in the six most frequently applied herbicides in 2005 demonstrate relatively stable total 

herbicide use, both glyphosate and mesotrione application area have progressively increased 

since 2000 (Figure 4). If MON87460 is offered without tolerance to glyphosate, it may signal a 

shift away from glyphosate and an increased reliance on other herbicide products. Similarly, a 

shift could also occur in insecticide application, if the drought tolerant trait were offered without 

an insect-resistance trait in MON87460. Given typical corn offerings, corn hybrid varieties 

produced with MON87460 will likely be stacked with insect resistant and herbicide tolerant 

events that have previously been determined to no longer be subject to the regulatory 

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act, because 

trait stacks represent a growing proportion of commercially-available corn varieties (Table 6 and 

Chapter 5). Based upon this observation, overall impact to current corn pesticide use practices 

are likely to be minimal. Adoption rates of stacked varieties are also likely to increase over time, 

as demonstrated by previous trends (USDA-ERS, 2010a). Accordingly, because of the 

popularity of herbicide tolerant crops, levels of tillage are likely to continue as currently 

practiced. 
37

Table 6. Percentage of herbicide-tolerant, insect-resistant, stacked trait, and total GE corn 

in select Great Plains states. 

State 

Herbicide 

tolerant 

(%) 

Insect 

resistant (Bt) 

(%) 

Stacked 

(%) 

Total 

GE (%) 

Kansas 28 22 40 90 

Nebraska 24 27 45 96 

North Dakota 34 22 37 93 

South Dakota 29 6 60 95 

Wyoming 27 18 40 85 

 Source: (USDA-ERS, 2010a). 

Figure 4. Herbicide application trends in U.S. corn production, 2000-2005. 

Source: (http://www.nass.usda.gov/). 

Note: Trends represent the six most frequently applied herbicides in corn (2005) 

4.3.3 Organic 

Certified organic corn represented approximately 0.2 percent (172,112 acres) of the 93.6 million 

planted U.S. corn acres in 2007 (USDA-ERS, 2010d). The 2007 certified organic corn acreage 

represents an increase of approximately 9 percent from the 131,000 certified organic acres in 

2005. Based on certified organic trends, it can be anticipated that organic acreage devoted to 

corn production will increase over time. 

Organic farming operations, as described by the NOP and administered by the USDA-AMS, 

must have distinct, defined boundaries and buffer zones between adjoining land not under 

0

20

40

60

80

100

2000 2001 2002 2003 2005

% of acres applied, A.I.

Year

Total herbicide

Atrazine

Glyphosate

Acetochlor

Nicosulfuron

S‐Metolachlor

Mesotrion
38

organic management to prevent unintended contact with prohibited substances (7 CFR 205.272). 

Organic production operations must also develop and maintain an organic production system 

plan approved by their accredited certifying agent (7 CFR 205.201). This plan enables the 

production operation to achieve and document compliance with the NOP, including the NOP 

prohibition on the use of excluded methods. Excluded methods include methods used to 

genetically modify organisms or otherwise influence their growth and development by means not 

possible under natural conditions or processes. 

Typically, there is more than one method for farms under organic practices to prevent unwanted 

pollen or seed from entering their fields including: isolation of the farm, physical barriers or 

buffer zones between organic production and non-organic production, as well as formal 

communications between neighboring farms (NCAT, 2003). The organic plan used as the basis 

for organic certification should include a description of practices used to prevent or reduce the 

likelihood of unwanted GE pollen or seed at each step in the farming operation, including 

planting, harvesting, storing and transporting the crop (NCAT, 2003). Organic plans should also 

include mechanisms to monitor the risk of GE pollen or seed co-mingling with the organic crop 

(Kuepper et al., 2007). 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 unwanted gene flow events (Krueger, 2007; NCAT, 2003). Thus, 

commonly used production practices for corn, and the practical methods typically used by corn 

farmers using organic methods currently provide many measures that greatly reduce the 

likelihood of accidental gene flow between GE and non-GE corn fields. Efficacy of certified 

organic plans and practices to prevent the likelihood of unwanted substances is best represented 

by the parallel increases in both GE corn and organic corn production since 2000. These 

practices protect organic crops and thus maximize profits and price premiums accorded to corn 

under organic production. APHIS will assume that farmers are already using, or have the ability 

to use, these common practices as APHIS’ baseline for the analyses of the following alternatives 

below. 

4.3.3.1 No Action Alternative: Organic 

Current availability of seed for conventional (both GE and non-GE) corn varieties, and those 

corn varieties that are developed for organic production, are expected to remain the same under 

the No Action Alternative. Under the No Action Alternative, MON87460 and its progeny would 

continue to be regulated articles under the regulations at 7 CFR part 340. This however, will not 

change the ready availability of other corn hybrid varieties produced through GE methods. GE 

corn will continue to represent a large majority of corn production acreage, with GE corn totaling 

88 percent of all corn production in the U.S. in 2007 (USDA-ERS, 2010a). Trends of 

conventional and organic commercial corn production will not change and will remain the same 

under the No Action Alternative. Planting and production of GE corn varieties and organic corn 

have both increased due to market demands over the last ten years, and these markets are likely 

to continue to increase under the No Action Alternative. 

4.3.3.2 Preferred Alternative: Organic 

A determination of nonregulated status of MON87460 is unlikely to significantly impact organic 

farmers that choose not to plant or sell corn products produced through genetic engineering or 

other non-organic production systems. Despite the wide-spread adoption of conventional and 
39

GE corn in the U.S. that amounted to 99.8 percent of total corn production in the U.S. in 2007, 

organic corn production has also continued to expand in recent years (USDA-ERS, 2010d). 

This continued expansion of organic corn acreage, though minor relative to non-organic national 

and state corn production, reinforces the capacity of current organic system plans to avoid use of 

excluded methods (and thus, loss of NOP certification) and the efficacy of these plans to 

increasingly produce agricultural products to meet demand of target markets in spite of the 

overwhelming presence of non-organic farming systems. 

States that represented major organic corn production areas (> 10,000 acres) in the 2007 

Agricultural Census included Iowa, Michigan, Minnesota, New York, and Wisconsin (Table 7). 

Organic corn production in these states represented 0.16 to 1.25 percent of total corn production 

in each state. Despite the presence of millions of corn acres produced through excluded methods, 

no organic grower in this, or any other organic corn production region, has lost organic 

certification status. Thus, presently certified methods to maintain organic production as 

prescribed by the National Organic Program is effective in the maintenance of organic corn 

production. Accordingly, regions that are not anticipated to adopt MON87460, GE varieties 

currently represents the majority of cultivated corn, organic corn production would still represent 

a fraction of total corn production and prescribed NOP methods would be just as effective in 

preserving certified organic status. 

Table 7. Non-organic and organic corn production (harvested acres) in 2007. 

Data were calculated from the 2007 Agricultural Census (USDA, 2009). 

State Total Corn 

Production 

(acres harvested)*

Percent 

Nonorganic 

Organic Corn 

Production 

(acres 

harvested)**

Percent 

Organic 

Alabama 288,881 100 0 0 

Alaska 1 100 0 0 

Arizona 61,408 100 0 0 

Arkansas 587,858 99.992 45 0.008 

California 675,445 99.588 2,780 0.412 

Colorado 1,172,893 99.893 1,257 0.107 

Connecticut 32,347 99.975 8 0.025 

Delaware 200,827 100 0 0.000 

Florida 100,542 99.978 22 0.022 

Georgia 510,709 99.991 48 0.009 

Hawaii 3,641 99.918 3 0.082 

Idaho 333,022 99.999 4 0.001 

Illinois 13,214,365 99.947 7,031 0.053 

Indiana 6,528,585 99.977 1,533 0.023 

Iowa 14,075,332 99.841 22,330 0.159 

Kansas 3,847,088 99.903 3,746 0.097 

Kentucky 1,409,781 99.990 138 0.010 
40

Table 7. Non-organic and organic corn production (harvested acres) in 2007. 

Data were calculated from the 2007 Agricultural Census (USDA, 2009). 

State Total Corn 

Production 

(acres harvested)*

Percent 

Nonorganic 

Organic Corn 

Production 

(acres 

harvested)**

Percent 

Organic 

Louisiana 726,897 100 0 0 

Maine 28,703 98.631 393 1.369 

Maryland 533,903 99.733 1,427 0.267 

Massachusetts 21,575 99.754 53 0.246 

Michigan 2,658,538 99.465 14,231 0.535 

Minnesota 8,352,731 99.726 22,864 0.274 

Mississippi 888,049 100 0 0 

Missouri 3,332,832 99.898 3,410 0.102 

Montana 83,344 99.996 3 0.004 

Nebraska 9,438,807 99.903 9,200 0.097 

Nevada 6,006 100 0 0 

New 

Hampshire 14,611 99.966 5 0.034 

New Jersey 100,766 99.991 9 0.009 

New Mexico 136,008 99.512 664 0.488 

New York 1,099,413 98.754 13,703 1.246 

North Carolina 1,028,533 99.933 689 0.067 

North Dakota 2,528,921 99.953 1,189 0.047 

Ohio 3,834,164 99.767 8,926 0.233 

Oklahoma 301,443 99.999 3 0.001 

Oregon 88,692 95.407 4,074 4.593 

Pennsylvania 1,427,111 99.653 4,954 0.347 

Rhode Island 2,549 100 0 0 

South Carolina 388,481 100 0 0 

South Dakota 4,841,686 99.933 3,245 0.067 

Tennessee 838,499 99.998 16 0.002 

Texas 2,121,694 99.859 2,990 0.141 

Utah 68,303 100 0 0.000 

Vermont 93,876 98.714 1,207 1.286 

Virginia 530,781 99.816 974 0.184 

Washington 294,929 97.651 6,927 2.349 

West Virginia 46,918 100 0 0 

Wisconsin 4,074,833 99.247 30,673 0.753 

Wyoming 86,740 99.618 331 0.382 

Note: * and ** represent corn for grain, corn for silage, popcorn, and sweet corn. 

Source: Data were calculated from the 2007 Agricultural Census (USDA, 2009) 
41

4.4 Physical Environment 

4.4.1 Water Usage and Water Quality 

Approximately 4,000 gallons of water is required to produce 1 bushel of corn (NCGA, 2007). 

Water use by corn is generally related to growth and development; prior to tassel 

development/anthesis, corn generally requires 0.1 inches per day; during grain fill, this water 

requirement increases to generally 0.3 inches per day (McWilliams 2002). Relative to other 

monocot crop plants, corn generally requires more water for optimal grain yield; however, this 

amount is generally less than dicot crop plants, due to increased photosynthetic efficiency in 

carbon fixation. 

Agricultural non-point source (NPS) pollution is the primary source of discharge pollutants to 

above- and underground bodies of water. Many different factors affect that NPS pollution 

frequency and amount, including the type of crop cultivated, plowing and tillage, and the 

application of fertilizers, herbicides, and pesticides (EPA, 2005). Discharge pollutants can occur 

in the form of direct chemical contaminants (fertilizer, herbicide, or pesticide derived) or direct 

physical particulates (erosion-related sediments), and indirectly contribute to higher water 

turbidity, increased algal blooms, and decreased oxygen content in a body of water (EPA, 2005). 

4.4.1.1 No Action Alternative: Water Usage and Water Quality 

Under the No Action Alternative, management practices that affect NPS frequency and 

abundance in current corn production systems would not change. MON87460 will continue to 

be regulated, and thus, its interaction with water quality and usage will continue to be limited to 

areas that were approved for regulated release by APHIS. Water use and water quality in these 

release areas will not change, as MON87460 will continue to share management practices with 

conventionally produced corn. 

4.4.1.2 Preferred Alternative: Water Usage and Water Quality 

The physiological response of MON87460 is similar to that of conventional corn, with the only 

exception being reduced yield loss under water-limiting conditions. When subject to water 

deficit, both MON87460 and conventional corn display similar magnitudes of effect on corn 

drought stress indicators, including but not limited to plant height, days to 50 percent pollen 

shedding/silking, grain moisture, and leaf chlorophyll content. The reduced yield loss phenotype 

of MON87460 is not enabled by increased water uptake, as demonstrated by several lines of 

evidence. Firstly, patterns of shoot and root fresh/dry weight between MON87460 and 

conventional corn are not significantly different under well-watered or water-limited conditions 

(Monsanto, 2010). If water uptake were increased in MON87460, it is plausible that shoot/root 

fresh weight would be increased in MON87460 while root/shoot dry weight remained similar 

compared to conventional corn. This pattern, however, was not observed and its absence 

suggests that water uptake is not increased in MON87460. The absence of increased water 

uptake is further validated by soil moisture depletion studies, where no significant differences in 

soil moisture depletion rates were observed between MON87460 and conventional corn 

(Monsanto, 2010). Taken in total, the physiological evidence and recorded measures of moisture 

depletion strongly indicate that MON87460 does not inherently transport more water than 

conventional corn. Consequently, MON87460 is unlikely to directly and significantly impact 
42

soil moisture availability, abundance, and usage in corn production regions any differently than 

conventional corn. 

Additionally, water quality is unlikely to be significantly affected by a determination of 

nonregulated status of MON87460. NPS pollution represents a major source of water quality 

impacts on above- and underground bodies of water. A major contributing factor to NPS 

pollution is soil erosion-mediated sedimentation and the resulting detrimental effects on soil 

structure and agrochemical runoff. The correlation between tillage practice and soil erosion is 

well documented, as is the correlation between no-tillage or reduced-tillage production systems, 

adoption rates of herbicide tolerant crops, and improved soil structure and quality. No-tillage or 

reduced-tillage strategies in corn production are contingent on continued herbicide use. 

MON87460 is not anticipated to significantly affect herbicide use, and thus, is not anticipated to 

significantly affect no-till or reduced-till systems currently utilized in corn production systems. 

Accordingly, adoption of MON87460 is unlikely to cause changes in current water quality trends 

associated with corn production practices. 

4.4.2 Soil 

The soil environment in and around corn fields is complex, and rich in microorganisms and 

arthropods. The corn root system modifies soil through its close association with several 

microbial groups such as bacteria, fungi, and protozoa (Bais et al., 2006). These interactions are 

generally complex and occur through multiple pathways. Plants can have direct or indirect 

chemical, physical, and biological effects on the soil. Bacteria typically represent the most 

abundant microbes in the soil followed by fungi. Collectively, microbial and arthropod groups 

play an important and particular role in the nutriment cycling capacity of the soil (Hoeft et al., 

2000; OECD, 2003). Specific crop management practices used for GE plants, such as pesticide 

applications, tillage, and application of inorganic and organic fertilizers can alter soils and the 

microbial and arthropod populations associated with it. 

4.4.2.1 No Action Alternative: Soil 

Under the No Action Alternative, MON87460 use would be limited to areas APHIS has 

approved it for regulated releases. Interactions with the soil would be limited to the areas 

approved for regulated releases, and would be minor if any, due to the small proportion of land 

compared to commercial corn production acreage. Therefore, there would be negligible impacts 

on soil under the No Action Alternative. 

4.4.2.2 Preferred Alternative: Soil 

Under the Preferred Alternative, MON87460 is not anticipated to significantly impact the quality 

of the soil on which it is cultivated, nor is it likely to significantly affect microbial populations or 

arthropod populations and the dynamic soil processes those organisms modulate. As previously 

described, tillage practice is strongly correlated with soil quality in agricultural production 

systems. The use of no-till or reduced till practices is unlikely to be significantly impacted by a 

determination of nonregulated status of MON87460, as herbicide application strategies will 

continue to be available to facilitate use of low impact tillage practices. 

Microbial and arthropod soil populations may be impacted by a corn crop through degradation of 

plant tissue following harvest and direct interaction with soil fauna through the corn root system. 
43

Compositional analysis of MON87460 forage tissue (i.e., stems and leaves) revealed no 

significant or consistent differences between it and conventional corn. Additionally, analysis of 

the gene products produced by MON87460, the neomycin phosphotransferase II and cold shock 

protein B have been shown to be safe for the environment (Monsanto, 2010). In particular, the 

NPTII protein has regularly been used in the selection of many transgenic crop varieties that have 

previously been determined to no longer be subject to the regulatory requirements of 7 CFR part 

340 or the plant pest provisions of the Plant Protection Act, further demonstrating the safety of 

this protein. Because of the similarities in composition between MON87460 and conventional 

corn, and the examined safety of the MON87460 gene products, it is not anticipated that 

degradation of MON87460 plant tissue following grain harvest will significantly impact 

microbial and arthropod soil populations compared to conventional corn. 

4.4.3 Air Quality 

Air quality may be affected by a variety of agricultural-related activities, including smoke from 

agricultural burning, tillage, traffic and harvest emissions, pesticide drift from spraying, and 

nitrous oxide emissions from the use of nitrogen fertilizers (Aneja et al., 2009; Hoeft et al., 

2000). These agricultural activities individually have potentially adverse environmental impacts 

on air quality. Tillage contributes to the release of GHGs because of the loss of CO2 to the 

atmosphere and the exposure and oxidation of soil organic matter (Baker et al., 2005). Emissions 

released from agricultural practices include carbon monoxide, nitrogen oxides, reactive organic 

gases, particulate matter, and sulfur oxides (EPA, 2010c). Nitrous oxide may also be released 

following the use of nitrogen fertilizer. Aerial application of pesticides may cause impacts from 

drift and diffusion. Pesticides may volatilize after application to soil or plant surfaces and move 

following wind erosion (Vogel et al., 2008). 

4.4.3.1 No Action Alternative: Air Quality 

Under the No Action Alternative, MON87460 interactions with the air would be limited to the 

areas that were approved for regulated releases by APHIS. Cultivation practices associated with 

corn production would not be affected. Air quality would still be affected by agronomic practices 

associated with corn cultivation and commercial corn production such as tillage and pesticide 

application. 

4.4.3.2 Preferred Alternative: Air Quality 

As previously discussed in Section 4.3.3, cropping practices associated with corn cultivation and 

commercial production, including tillage and pesticide application, are not likely to be different 

between MON87460 and conventional corn. Thus, a determination of nonregulated status of 

MON87460 will not change the use of tillage, use of agriculture equipment, irrigation, pesticide 

applications and fertilizer applications in commercial corn production. 

The agronomic performance and physical impact of MON87460 is similar to that of 

conventional corn, except under water-limiting conditions. When subject to water-limiting 

conditions, MON87460 exhibits a reduced yield phenotype. Accordingly, the physical impact of 

MON87460 on air quality is not anticipated to be significantly different from that of 

conventional corn, due to the requirement of similar intensive management practices between 

MON87460 and conventional corn. 
44

4.4.4 Climate Change 

U.S. agricultural crop production is identified as a major source of GHG emissions, second only 

to the U.S. energy sector. Crop production activities contribute directly to emissions of GHGs 

through a variety of processes, including the direct combustion of fossil fuels to support 

mechanized activities, abundance and frequency of agricultural chemical application (such as 

fertilizers) and other management practices, and the degradation of agricultural residues in the 

field or processing plant. Classes of crops planted are relevant to climate change, through cropdependent management practices and soil impacts. Additionally, geographic location and soil 

composition may also affect climate change through alterations in dynamic geophysical soil 

processes. Climate change itself may force changes to agricultural practices by altering 

agricultural weed and pest pressure (IPPC, 2007). Indirect effects of new crops will be 

determined by the traits engineered into organisms and the management strategies used in the 

production of these organisms. 

4.4.4.1 No Action Alternative: Climate Change 

Under the No Action Alternative, MON87460 use would be limited to areas APHIS has 

approved it for regulated releases. Agronomic management practices and phenotypic 

characteristics regarding MON87460 are similar to those of conventional corn; thus, impact 

between corn varieties would be minimal. Additionally, measurable effects from these confined 

field releases would be minor due to the small scale of management and acreage relative to 

current corn production systems in the U.S. 

4.4.4.2 Preferred Alternative: Climate Change 

A determination of nonregulated status of MON87460 is unlikely to significantly affect current 

corn management practices. Management decisions regarding agricultural affecters of climate 

change, including tillage, agricultural chemical application, and rotational strategies are not 

anticipated to differ between MON87460 and conventional corn. In particular, due to the 

continued availability of herbicide choice in MON87460 management, no-till or reduced till 

practices will likely continue to mitigate soil erosion, stabilizing soil quality attributes and 

reducing GHG emissions. 

Agronomic performance and phenotypic characteristics of MON87460 is not significantly 

different from conventional corn, with the exception of reduced yield loss under water-limiting 

conditions. Accordingly, the physical impact of MON87460 on climate change is not anticipated 

to be significantly different from that of conventional corn because MON87460 requires similar 

management conditions. Intensive management will continue to be practiced on a scale similar 

to current levels of U.S. corn production, because of the phenotypic equivalence of MON87460 

and conventional corn. Additionally, due to the scale of projection time related to climate change 

(CCSP, 2009), an accurate description of effects is difficult and will not likely be unique to 

MON87460. 
45

4.5 Animal and Plant Communities 

4.5.1 Animal Communities 

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

seasonally use grain, and invertebrates can feed on the plant during the entire growing season. 

The cumulative effects analysis for this issue is found in Chapter 5. 

4.5.1.1 No Action Alternative: Animal Communities 

Under the No Action Alternative, environmental releases of MON87460 would be under APHIS 

regulation, as they have since 2002 (USDA-APHIS, 2010). Animal incursions would be limited 

to regulated field trials and there would be no change in impacts on animals. A consultation with 

FDA was successfully completed for CSPB and NPTII proteins of MON87460 (Appendix A), 

which demonstrated a lack of toxicity and allergenicity of MON87460 for human and animal 

consumption. Based upon the FDA consultation, APHIS supports Monsanto’s conclusions that 

MON87460 is considered safe for animal consumption. USDA analysis shows that while some 

increase in corn acres is expected, CRP lands in 2011 through 2020 will not change significantly, 

so although some of these lands may be used for new corn production, these conversions to corn 

will likely be limited. 

4.5.1.2 Preferred Alternative: Animal Communities 

Under the Preferred Alternative, MON87460 would no longer be subject to the regulatory 

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. The 

agronomic practices used to produce MON87460 are similar to those used to produce 

conventionally grown corn. The introduced gene products of MON87460 do not contain 

pesticidal activity and are not aimed at any target organisms as a control measure. Therefore, the 

evaluation of potential effects on animals of MON87460 focuses solely on the nontarget impacts 

from MON87460, especially the introduced proteins, CSPB and NPTII. APHIS analyzed the 

potential impacts of MON87460 on animal species including (1) exposure from directly 

contacting or consuming MON87460, (2) exposure from increased use of pesticides or 

herbicides, and (3) conversion of CRP land to MON87460 corn production. 

Several phenotypic (i.e., appearance or observable physical characteristics) and agronomic (i.e., 

relating to soils and crop production) traits encompassing five general data categories were 

evaluated for MON87460 including: (1) phenotypic growth and development, including 

vegetative and reproductive growth, (2) germination and dormancy, (3) pollen viability and 

morphology, (4) plant interactions with insects, diseases, and abiotic stressors, and (5) 

persistence in cultivated fields or areas outside of cultivation (Monsanto, 2010). No differences 

between MON87460 and non-drought-tolerant corn were noted except for the intended droughttolerant trait. 

CSPB is not known to exert any effects on pest and non-pest organisms. Arthropod (pest and 

beneficial) abundance was assessed and indicated no significant impact on non-target organisms. 

APHIS concludes that no species exposed to MON87460 showed adverse consequences and that 

MON87460 is not different in its environmental interactions relative to conventional corn. 

Because no differences in physical traits or characteristics were observed between MON87460 
46

and conventional corn, it is not expected that MON87460 would impact the behavior of 

arthropods found in or around corn fields. 

The transgene proteins in MON87460 are not expected to affect animals through toxicity or 

allergenicity. The donor organism of the CSPB protein, Bacillus subtilis, is not pathogenic, is 

often used as a food additive, is present in many fermented foods, and has a history of safe 

consumption. The FDA acknowledged that enzyme preparations from Bacillus subtilis are 

generally recognized as safe (FDA, 1999, 2010). The petitioner assessed the risks to animals 

from the transgene proteins present in the foods and feeds derived from MON87460, and the 

results indicated no adverse effects, even at the highest tested dose levels (Monsanto, 2010). 

Furthermore, the CSPB protein represents no more than 0.00007 percent of the total protein in 

the grain of MON87460, and neither transgene protein shares any amino acid sequence 

similarities with known allergens, gliadins, glutenins, or protein toxins that have adverse effects 

on mammals. Because there is no toxicity or allergenicity potential with the transgene protein of 

MON87460, there would be no direct or indirect toxicity or allergenicity impacts on wildlife 

species that feed on corn or the associated biological food chain of organisms. A consultation 

with FDA was successfully completed for CSPB and NPTII proteins of MON87460 (Appendix 

A), which demonstrated a lack of toxicity and allergenicity of MON87460 for human and animal 

consumption. 

MON87460 is not expected to have nutritional effects on any animal species (including 

threatened and endangered species) that feed on it. Grain and forage samples of MON87460 and 

a control from several locations were evaluated for major nutrients and secondary metabolites 

(Monsanto, 2010). The results indicate that MON87460 is compositionally and nutritionally 

equivalent to conventional corn except for the expression of the transgene proteins (CSPB and 

NPTII). 

The CRP was initially established to protect land against soil erosion by taking lands out of 

agriculture production and planting native vegetation. In turn, the native vegetation provided 

habitat to wildlife, most notably birds. Many grassland birds and waterfowl use CRP land, 

though the animals present would ultimately be dependent on the region and habitat type 

(Johnson, 2005). Former CRP land returned into agricultural production may also provide land 

for additional corn acreage, although this contribution is likely to be minimal based on 

projections and farmer surveys (USDA-ERS, 2011a, 2011c). Following a period of prolific corn 

production (2006-2007), only a small proportion of farms (2 percent) brought CRP land back 

into corn production, further suggesting that crop shifting and not expansion into CRP land is 

primarily responsible for recent increases in domestic corn production (USDA-ERS, 2011a). 

Interestingly, total CRP acreage often mirrors that of corn acreage, further suggesting that CRP 

land does not generally return to corn cultivation (Figure 5). In the event that farmers convert 

current CRP land to MON87460 production, some birds and mammals that use CRP land for 

food and/or cover may be displaced to nearby areas of similar habitat. Under the Preferred 

Alternative, however, MON87460 is not expected to significantly affect animal communities in 

CRP land, as the conversion of CRP land to corn production occurs as relatively low levels. 
47

Figure 5. U.S. corn and CRP acreage between 1988 and 2010 (USDA-FSA, 2009; 

USDA-NASS, 2011b). 

APHIS has reviewed and accepts the data submitted by the applicant, which are similar to the 

data submitted during the FDA consultation process for the CSPB and NPTII proteins of 

MON87460 (Appendix A). No major impacts on animals, either directly or indirectly, are 

expected from a determination of nonregulated status of MON87460; impacts would be similar 

to the No Action Alternative. 

4.5.2 Plant Communities 

Corn production acreage is host to many plant species as well. The landscape surrounding a corn 

field varies depending on the region. In certain areas, corn fields may be bordered by other corn 

(or any other crop); fields may also be surrounded by wooded or pasture/grassland areas. 

Therefore, the types of vegetation, including weeds, around a corn field depend on the area where 

the corn is planted. A variety of weeds dwell in and around corn fields; those species will also vary 

depending on the geographic region where the corn is planted. Corn itself is not sexually 

compatible with any other native plant species found in the U.S. 

4.5.2.1 No Action Alternative: Plant Communities 

Under the No Action Alternative, environmental releases of MON87460 would be under APHIS 

regulation, as they have since 2002 (USDA-APHIS, 2010). No changes in impacts on plant 

species compared to any current effects due to conventional corn varieties are anticipated. 

4.5.2.2 Preferred Alternative: Plant Communities 

MON87460 is not expected to become more invasive in natural environments, compete with 

native vegetation, or have any different effect on habitat than conventional corn (USDA-APHIS, 

2010). Corn struggles to survive without human assistance and does not possess traits that are 

characteristic of successful weeds (Baker, 1965; Galinat, 1988; Keeler, 1989). Like many 

domesticated crops, corn seed from a previous year’s crop can lie dormant over winter and 

200

250

300

350

400

500

600

700

800

900

1000

CRP acreage

(100,000 acres)

Corn Acreage

(100,000 acres)

Year

CRP Corn
48

germinate the following year. For example, corn seedlings often established themselves in 

soybean fields following a corn crop. Physical or chemical methods are often applied to 

eradicate these corn seedlings. Any seedlings not removed do not typically result in feral 

populations in subsequent years. 

Possible Weediness of MON87460 

For the majority of the agronomic traits assessed, there were no statistically significant 

differences between MON87460 and nontransgenic control (Monsanto, 2010). No biologically 

meaningful differences were detected in the germination and dormancy of seed from 

MON87460. In particular, the absence of hard seed supports a conclusion of no increased 

weediness potential of MON87460 compared to conventional corn for germination and 

dormancy characteristics (Monsanto, 2010). No differences were detected in pollen morphology 

or viability between MON87460 and the control (Monsanto, 2010). Results from the genotypeenvironmental interaction assessments also support the conclusion that MON87460 has no 

increased susceptibility or tolerance to specific diseases, arthropods, or abiotic stressors beyond 

drought. Development of a deep root system is typically one of the agronomic traits that have the 

potential to enhance weediness in the natural environment. However, that may not be the case 

with corn, as inbred lines with poor early root development exhibited higher yields under drought 

stress than ones with accelerated early development of roots (Bruce et al., 2002). It has been 

reasoned that the improved performance of corn cultivars to drought stress probably comes from 

better water use efficiency (Messmer et al., 2009). Consistent with this observation, soil 

moisture depletion studies between MON87460 and its respective control demonstrate that water 

depletion rates are similar between both MON87460 and its respective control (Monsanto, 2010). 

Finally, MON87460 was not altered in its ability to volunteer in cultivated fields or survive in 

areas not managed for agricultural production compared to conventional corn. 

The data submitted to APHIS indicate that MON87460 exhibits no characteristics that would 

improve the ability of this corn to survive without human intervention, and that its cultivation 

will not interfere with the cultivation of other corn hybrids or result in its uncontrolled spread into 

non-agricultural environments. Because MON87460 does not possess traits of a successful weed 

and would not spread into non-agricultural environments, there would be no impact to natural 

environments or habitats. 

Possible Weediness of MON87460 if Hybridized with Other Plants 

MON87460 is not expected to form hybrids with any plant species (including threatened and 

endangered species). APHIS evaluated the potential for gene flow to occur from MON87460 to 

sexually compatible wild relatives. As stated previously, cultivated corn is sexually compatible 

with its closest relative, teosinte, and with members of the genus Tripsacum, although to a much 

lesser degree (Mangelsdorf, 1974; OECD, 2003; Wilkes, 1967). Corn and teosinte are 

genetically compatible, wind-pollinated, and can hybridize when close to each other, which is 

only likely to occur in Mexico and Guatemala because teosinte is not present in the U.S., except 

for a few small feral populations of Zea mexicana in Alabama, Florida, Maryland (USDANRCS, 2010), and Zea perennis in South Carolina (USDA-NRCS, 2011). Tripsacum species 

have one less chromosome than corn but can hybridize with corn, although it is very difficult and 

requires special techniques, and the hybrids have a high degree of sterility and are genetically 

unstable (Mangelsdorf, 1974). Crosses between corn and Tripsacum dactyloides can be made, 
49

but only through human intervention and, even then, it is extremely difficult (CFIA, 1994). 

MON87460 is not likely to hybridize with sexually compatible species in the U.S. because of 

differences in factors such as flowering time, geographical separation, and development factors 

(Galinat, 1988). Tripsacum dactyloides and Tripsacum floridanum would not be affected by 

MON87460 because of the difficulty of hybridizing with these species. The potential impact due 

to the limited potential for gene flow into teosinte is not expected to be any different than that of 

other cultivated corn varieties. Based on these considerations, MON87460 would pose no direct 

or indirect impacts on sexually compatible wild relatives. 

Other Possible Impacts 

The introduced gene products of MON87460 do not contain pesticidal activity and are not aimed 

at any target organisms as a control measure. As discussed in Cropping Practices Section 

(Preferred Alternative), MON87460 does not contain any herbicide tolerant or insect resistant 

traits, and adoption of MON87460 is not anticipated to change current corn agricultural practices. 

Minor impacts on plant populations could occur if farmers converted current CRP land to 

MON87460 production. The extent of impacts depends on the amount of CRP land converted to 

agriculture. However, the USDA (USDA-ERS, 2011c) projects minor increases in corn acreage 

from 2011 through 2020 and little change in CRP land; and an increase in corn in 2011 appears 

to be at the expense of wheat acreage. As previously noted, cropland in the U.S. has been 

declining as more cropland has been converted to other types of land than other types of land 

have been converted to cropland (NRCS, 2011). 

Overall, no major impacts on plants, either directly or indirectly, are expected from a 

determination of nonregulated status of MON87460; impacts would be similar to the No Action 

Alternative. 

4.5.3 Biodiversity 

Biological diversity, or the variation in species or life forms in an area, is highly managed in 

agricultural systems. Farmers typically plant crops that are genetically adapted to grow well in a 

specific area of cultivation and have been bred for a specific market. In the case of corn 

agriculture, varieties have been developed for food processing needs (e.g., waxy corn), consumer 

qualities (e.g., blue corn or white corn), or for use as a vegetable (e.g. sweet corn). In 

conventional agriculture, farmers want to encourage high yields from their corn crop, and will 

intensively manage the ‘plant communities,’ or weeds, found in corn crops through chemical, 

cultural, or mechanical means. Animals, particularly insect and other pest species, will also be 

managed through chemical and cultural controls to protect the crop from damage. Therefore, the 

biological diversity in agricultural systems (the agro-ecosystem) is highly managed and may be 

lower than in the surrounding habitats. 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 management, including selection 

and use of insecticides and herbicides; and 4) extent of isolation of the agro-ecosystem from 

natural vegetation (Southwood and Way, 1970). 
50

4.5.3.1 No Action Alternative: Biodiversity 

Under the No Action Alternative, environmental releases of MON87460 would be under APHIS 

regulation. Animal and plant species that typically inhabit seed corn and commercial production 

systems will be continue to be affected by the management plan of typical conventional corn 

production, which includes the use of mechanical, cultural, and chemical control methods. 

4.5.3.2 Preferred Alternative: Biodiversity 

As discussed above in Plant and Animal Communities (of Environmental Consequences section) 

the Preferred Alternative is expected to have no impact on animal and plant species (including 

threatened and endangered species and critical habitat) for areas where the adoption of 

MON87460 would not convert CRP land to MON87460 production. It is not expected that use 

of MON87460 in existing corn fields would result in any changes in herbicide or pesticide 

application. Cultivation of MON87460 seed requires the same agronomic practices as 

conventional corn production. Animal and plant species that typically inhabit seed-corn 

production systems will be managed as in conventional corn production, likely with the use of 

mechanical, cultural, and chemical control methods. Potential overall impacts from the 

introduction of MON87460 into existing cornfields that would not require a change in herbicide 

or pesticide use would be similar to the No Action Alternative. Therefore, there would be no 

impact to biodiversity under this scenario of the Preferred Alternative. 

For actions where: 1) MON87460 would replace another crop; 2) land would be converted from 

inactive cropland to active cropland using MON87460; 3) planting MON87460 would require an 

increase in pesticide or herbicide use; or 4) CRP lands would be converted to MON87460 

production, the impact to biodiversity would be considered minor based on the following 

discussion. 

The replacement of a different crop (such as soybeans) with MON87460 may likely result in a 

shift in biodiversity (different animals and plants might be present). However, as previously 

stated, biodiversity in any agricultural system is highly managed, and rotating from one crop to 

MON87460 would not be likely to affect the overall species richness or abundance. 

If farmers substituted organic corn cultivation with MON87460 cultivation, local biodiversity 

could decline. Bengtsson et al. (2005) analyzed the effects of organic farming on species 

richness and abundance using meta-analysis of literature published before December 2002. Their 

results indicated that, compared to conventional farming systems, organic farming often has 

positive effects on species richness and abundance, but that its effects are likely to differ between 

organism groups and landscapes. For example, the Bengtsson et al. (2005) review showed that, 

on average, organisms were 50 percent more abundant in organic farming systems than 

conventional systems, but the results were highly variable between studies and organism groups. 

Birds, predatory insects, soil organisms, and plants responded positively to organic farming, 

while non-predatory insects and pests did not. The authors suggest that positive effects of 

organic farming on species richness can be expected in intensively managed agricultural 

landscapes, but not in small-scale landscapes comprised of many other habitat types (Bengtsson 

et al., 2005). 
51

The biodiversity in agricultural systems is highly managed and is likely lower than in the 

surrounding habitats. Therefore, the conversion of inactive cropland or CRP land to MON87460 

production and use of pesticides and herbicides likely may result in a loss of local biodiversity. 

The level of impact would depend on the amount of inactive cropland and CRP land converted to 

agriculture and the types of herbicides or pesticides used. APHIS cannot predict the amount of 

inactive cropland and CRP land that may be converted to MON87460 production. As noted 

earlier, if all converted CRP land were used to grow corn, the impacts would affect only 3 

percent of all existing corn planting. In addition, USDA- ERS expects that total CRP lands will 

change little between 2011 and 2020 (USDA-ERS 2011b; see also Environmental Scope, 

Section 4.1). Consequently, no notable impacts on animal and plant populations are expected to 

occur at the regional level. Finally, cropland in the U.S. has been declining, as more cropland 

has been converted to other types of land than other types of land have been converted to 

cropland (NRCS, 2011). 

4.5.4 Gene Flow 

4.5.4.1 No Action Alternative: Gene Flow 

Under the No Action Alternative, environmental releases of MON87460 would be under APHIS 

regulation. Horizontal gene flow from corn to other organisms would be unlikely to occur. Gene 

flow to other GE and conventional crops, to the extent that it occurs will continue to occur, with 

little impact on marketing and sales of corn seed and corn for processing. 

4.5.4.2 Preferred Alternative: Gene Flow 

Pollen- or seed-mediated gene flow would represent potential direct impacts of MON87460 but 

are not expected to pose a greater impact than that of currently cultivated corn varieties. Besides 

the ability to exhibit a reduced yield phenotype when subject to water-limiting conditions, 

MON87460 does not notably differ from other corn varieties. Under well-watered conditions, 

MON87460 did not notably differ from non-GE comparable varieties (Monsanto, 2010). No 

evidence of changes to pollen attributes or seed attributes were observed (Monsanto, 2010). 

Horizontal gene flow from MON87460 (or any other GE plant) to soil-borne microorganisms is 

unlikely, as no evidence has produced under field conditions, suggesting that horizontal gene 

transfer did not occur at detectable levels or that its potential impacts are negligible in field 

conditions (Badosa et al., 2004; de Vries and Wackernagel, 2005; Demanèche et al., 2008; 

Gebhard and Smalla, 1999; Paget et al., 1998). Gene flow between plants will therefore be 

determined by the factors discussed above, including differences in flowering time between 

hybrid GE lines and inbred lines (such as some organic crops), distance between a pollen source 

and recipient plants, and the impact of environmental factors such as wind, temperature, and 

humidity on viability and dispersal of corn pollen. 

To review, pollen-mediated gene flow from MON87460 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 spp. parviglumis in Florida and to less 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. a very minor impact. 
52

Based on the information detailed in the sections above, pollen-mediated gene flow between corn 

crop fields planted with MON87460 and neighboring corn fields is not expected to be 

substantially different from pollen-mediated gene flow between any other two corn varieties. As 

reviewed by Sanvido et al. (2008) pollen-mediated gene flow decreases rapidly with increasing 

distance from source crop fields, regardless of corn cultivar or variety. As such, the pollenmediated gene flow from MON87460 will not be substantially different and represents a minimal 

impact. Section 2.1.2 describes the cropping practices corn farmers use to maintain seed purity 

between corn varieties. Because there were no identified differences in traits (besides drought 

tolerance) between conventional and MON87460, there is no reason to expect that cropping 

practices utilized to maintain genetic purity of corn varieties (AOSCA, 2009) would be any less 

effective for cultivation of MON87460. Because MON87460 exhibits decreased yield loss 

under water-limiting conditions (Monsanto, 2010), it can be suggested that drought conditions 

may increase the risk of pollen-mediated gene flow due to less pollen abortion or changes in 

floral phenology. However, no evidence for changes in pollen structure, function, abundance, or 

dispersal was reported in MON87460 under water-limiting conditions (Monsanto, 2010). Under 

conditions of drought, corn plants (conventional, organic, or GE) can continue to produce pollen, 

but the window of fertilization is shortened because of the delaying effects of drought on 

deployment of female reproductive structures (silks) and reductions in pollen viability (Hall and 

Twidwell, 2002). Therefore, pollen-mediated gene flow from MON87460 under drought 

conditions would not be expected to differ from conventional corn and would be limited, in part, 

because of shortened pollen viability as a result of dry conditions and a reduced window for 

fertilization on silks of adjacent corn fields. 

Seed-mediated gene flow is of minimal concern due to the lack of seed dispersal and feral traits 

in corn. As described in Section 2.1.2.2 all corn seed producers (including organic seed 

producers) use standard procedures to assure seed quality. In research conducted to evaluate 

MON87460 (Monsanto, 2010), the expression of the cspB conveys a drought resistance trait that 

decreases yield loss when subject to reduced water conditions. If MON87460 seeds were able to 

successfully disperse out of crop fields by natural mechanisms (e.g., extreme weather) or humanmediated mechanisms (e.g., transport), persistence of the corn could not be expected to produce a 

feral population because the shatter and dispersal attributes of MON87460 are not reported to be 

different from conventional corn. The only phenotypic difference between MON87460 and 

conventional corn varieties is tolerance of mild drought conditions. Therefore, the ability to 

establish and persist as a feral weed would be extremely low and certainly not likely to be any 

greater than other varieties of corn. The drought tolerant modification would not allow feral 

corn seeds to colonize new habitats or become a greater weed, because the trait confers reduced 

yield loss and does not alter any other corn traits. 

4.6 Human Health 

This section focuses on whether the proposed action affects overall public health and worker 

safety. For MON87460, the evaluation of human health impacts involves the potential effects of 

the two inserted genes – cold shock protein B (cspB) and neomycin phosphotransferase (nptII) – 

and the expressed proteins (CSPB and NPTII). Public health concerns relating to MON87460 

include food and product safety, allergenicity, toxicity, and nutritional changes (Section 4.6.1). 

Indirect health effects to workers, such as from changes in pesticide use, related to the farming of 
53

MON87460 are considered (Section 4.6.2). Also, indirect food-safety issues from livestock feed, 

such as consumption of animal products from livestock, are addressed (Section 4.6.3). 

4.6.1 Public Health 

Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the 

products they market are safe and properly labeled. Food and feed derived from MON87460 

must be in compliance with all applicable legal and regulatory requirements. GE organisms for 

food and feed may undergo a voluntary consultation process with the FDA prior to release onto 

the market. Monsanto consulted with FDA about food and feed derived from MON87460 and 

provided a comprehensive assessment of food and feed safety data on the CSPB and NPTII 

proteins in MON87460. The FDA has determined Monsanto’s submission to be complete (FDA, 

2010). MON87460 does not contain a biotechnology-derived plant-incorporated protectant or a 

biological control organism, and therefore is not regulated by the EPA. 

4.6.1.1 No Action Alternative: Public Health 

Under the No Action Alternative, MON87460 would continue to be a regulated article. Human 

exposure to this product would be limited to those individuals involved in cultivation under 

regulated conditions. Exposure to existing traditional and GE corn would not change under this 

alternative. The status of Monsanto's consultation with FDA on the CSPB and NPTII proteins in 

MON87460 would not change under the No Action Alternative. 

4.6.1.2 Preferred Alternative: Public Health 

Under the Preferred Alternative, it is expected that members of the public would primarily come 

in contact with the introduced transgenes (i.e., cspB and nptII) and CSPB and NPTII proteins 

through dietary exposure to food and products derived from MON87460. Generally, proteins 

containing cold shock domains are ubiquitous in nature, being present in many plants and 

common bacteria, including species that are normally present in gastrointestinal flora. Cold 

shock proteins have no known toxicity and are not associated with pathogenicity. Based on the 

evidence provided (Monsanto, 2010), the NPTII and CSPB proteins are anticipated to present no 

potential adverse effects to exposed organisms, including humans, in the environment (Fuchs et 

al., 1993a; Fuchs et al., 1993b). The following paragraphs summarize the supporting information 

from the safety assessment performed for NPTII and CSPB proteins found in MON87460. 

The safety of NPTII has been addressed in multiple publications (EFSA, 2004; Fuchs et al., 

1993a; Fuchs et al., 1993b; Nap et al., 1992). Several products containing NPTII have been 

approved by regulatory agencies on a global basis. EPA established an exemption from the 

requirement of a tolerance for NPTII for use as a selectable marker in raw agricultural 

commodities (40 CFR Part 180.1134). In 2007, the European Food Safety Authority (EFSA) 

affirmed its conclusion that the presence of nptII does not pose a threat to human health or the 

environment. Moreover, the USDA previously evaluated the safety of NPTII in several 

biotechnology-derived commercial crops that have undergone previous safety assessments (e.g., 

so far NPTII was used as a selectable marker in 28 petitions that have previously been 

determined to no longer be subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest provisions of the Plant Protection Act; http://www.isb.vt.edu/cfdocs/biopetitions1.cfm), 

including corn. 
54

Based on assessments performed with bioinformatic tools, such as the FASTA algorithm and the 

PROTEIN and TOXIN6 databases, NPTII and CSPB were shown not to share any amino acid 

sequence similarities with known allergens, gliadins, glutenins, or protein toxins which have 

adverse effects on mammals (Burzio et al., 2008; Tu, 2009). 

Acute oral toxicity studies for the CSPB proteins conducted on mice did not result in any 

observed adverse effects, even at the highest tested dose levels (Smedley, 2008). A dietary safety 

assessment was performed to evaluate the potential risks to humans and animals from CSPB and 

NPTII proteins present in the foods and feeds derived from MON87460. The ratio of the no 

observable effect level (NOEL) for CSPB and NPTII to the estimated dietary intake, also called 

the margin of exposure (MOE), was estimated to be greater than or equal to 26,700 and 

454,000,000 for the U.S. population, respectively. In general, MOEs of more than about 1,000 to 

3,000 are considered an adequate margin of safety (GAO, 2001). For children aged 1 through 6 

years, representing the age group with the highest corn to body weight ratio (i.e., most 

sensitivity), the MOE was greater than or equal to 11,400 and 208,000,000 for CSPB and NPTII, 

respectively. 

The donor organism of the CSPB protein, B. subtilis, has been shown to be non-pathogenic. 

Additionally, it has been frequently used as a food additive and is found in many fermented 

foods which have been safely consumed by humans for a long time. Enzyme preparations from 

this organism have been designated by the FDA as generally recognized as safe (GRAS) since 

1999 (FDA, 1999, 2010). 

The CSPB protein shares a high percent of identity with CSPs present in other bacterial species 

widely used by the food industry and with CSD-containing proteins in plant species used as food. 

The CSPB protein is homologous to the CSP proteins found in the genera Lactobacillus, 

Lactococcus, Bifidobacterium, and E. coli, which are normally present in gastrointestinal flora 

and, therefore, considered to be safe. The strains of lactic acid bacteria, Bifidobacterium and 

Lactobacillus, are the most common type of bacteria used in the dairy industry for preparation of 

probiotic products containing live bacterial cultures. In addition, Bacillus, Lactobacillus, and 

Lactococcus species containing CSPs are utilized in many food fermentation processes of milk, 

meats, cereals, and vegetables. 

Digestive fate experiments conducted with the CSPB protein demonstrated that the full-length 

protein is rapidly digested in simulated gastrointestinal fluid, a characteristic shared among many 

proteins with a history of safe consumption. Proteins that are rapidly digestible in mammalian 

gastrointestinal systems are unlikely to be allergens when consumed. Additionally, the CSPB 

protein represents no more than 0.00007 percent of the total protein in the grain of 

MON87460.Compositional comparisons between MON87460 and conventional corn presented 

by Monsanto showed no biologically meaningful differences for grain and forage compositions 

either for major nutrients, antinutrients, secondary metabolites related to normal growth and 

development or drought stress responses (Monsanto, 2010). Therefore, based on this data, it is 

reasonable to assume that the foods and feeds derived from MON87460 can be considered 

compositionally equivalent to those derived from conventional corn. 

Based on the assessment of laboratory data provided by Monsanto in the submitted petition and 

an analysis of the scientific literature (USDA-APHIS, 2010), along with the completion of the 

consultation process with FDA regarding the CSPB and NPTII proteins of MON87460, APHIS 
55

has concluded that under the Preferred Alternative, a determination of nonregulated status of 

MON87460 would have no expected impacts on public health. 

4.6.2 Worker Safety 

EPA’s Worker Protection Standard (WPS) (40 CFR Part 170) was published in 1992 to require 

actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and 

pesticide handlers. The WPS offers protections to more than two and a half million agricultural 

workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, 

and greenhouses. The WPS contains requirements for pesticide safety training, notification of 

pesticide applications, use of personal protective equipment, restricted entry intervals following 

pesticide application, decontamination supplies, and emergency medical assistance. 

4.6.2.1 No Action Alternative: Worker Safety 

During agricultural production of corn, agricultural workers and pesticide applicators may be 

exposed a variety of EPA-registered pesticides during application of these chemicals to crops. 

These chemicals would be expected to include those products currently used for insect pest and 

plant pest management. Under the No Action Alternative, exposure to these agricultural 

chemicals during corn production would remain the same as under current conditions. 

4.6.2.2 Preferred Alternative: Worker Safety 

Agricultural production with MON87460 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 MON87460 would remain the same as those 

under the No Action Alternative. 

4.7 Livestock Feed 

This section addresses the use of MON87460 as animal feed, and the potential effects of this use 

on livestock health, especially as it pertains to any effects on human health from ingestion of or 

other exposure to livestock products such as meat and milk. 

4.7.1 No Action Alternative: Livestock Feed 

Under the No Action Alternative, MON87460 would continue to be limited to areas APHIS has 

approved it for regulated releases. Thus, there would be no additional risks or benefits to 

livestock feed safety from MON87460. 

4.7.2 Preferred Alternative: Livestock Feed 

As discussed in Sections 4.6.1 an extensive safety evaluation of the inserted genes (cspB and 

nptII) and proteins (CSPB and NPTII) expressed in MON87460 indicated that they are not 

expected to be allergenic, toxic, or pathogenic in mammals. Monsanto consulted with FDA 

about food and feed derived from MON87460 and provided a comprehensive assessment of food 

and feed safety data on the CSPB and NPTII proteins in MON87460. The FDA has determined 

Monsanto’s submission to be complete (FDA, 2010). Additionally, no gene transfer to 
56

gastrointestinal flora is expected. Both CSBP and NPII proteins have a history of safe 

consumption in the context of other food and feeds (Burzio et al., 2008; Tu, 2009). 

Compositional analyses of forage and grain tissues from MON87460 confirmed that the corn 

grain and forage derived from MON87460, and the intended foods and feeds derived from 

MON87460, can be considered compositionally and nutritionally equivalent to conventional corn 

hybrids that have a history of safe consumption that are currently in commerce. Therefore, any 

food, such as meat and milk, derived from animals that are fed MON87460 are not expected to 

differ from food derived from animals fed conventional corn. 

The results of a dietary safety assessment indicate that animals exposed to CSPB and NPTII 

present in the foods and feeds derived from MON87460 will be low, with chickens, swine, and 

dairy cows consuming only nanogram quantities of each protein per kilogram of body weight 

(Monsanto, 2010). 

The FDA has evaluated horizontal gene transfer from the use of antibiotic resistance marker 

genes. The FDA has concluded that the likelihood of transfer of antibiotic resistance genes from 

plant genomes to microorganisms in the gastrointestinal tract of humans, animals, or the 

environment, is remote (FDA, 1998). 

Based on the assessment of data provided by the applicant and review of additional literature, the 

Preferred Alternative is not anticipated to have any adverse effects on livestock feed and, 

consequently, humans. 

4.8 Socioeconomic 

The CEQ and NEPA define effects on the human environment broadly to include economic and 

social impacts in addition to physical impacts, although economic or social impacts, by 

themselves, would not trigger the need for an Environmental Impact Statement (EIS) (40 CFR 

1508.8, 1508.14). 

4.8.1 Domestic Economic Environment 

Domestic demand for corn in the U.S. comes from its domestic use for feed, ethanol production, 

food, and seed, and totaled 11.1 billion bushels in the 2009/10 marketing year (USDA-ERS, 

2011c). Exports added another 2 billion bushels to total U.S. corn use. Demand is satisfied 

almost entirely by domestic supply, with few imports, the U.S. being largely a net exporter of 

corn. The U.S. produced 13 billion bushels of corn in the 2009/10 marketing year and corn 

occupied the most acreage of any crop in the country (USDA-ERS, 2011c). In the 2009/10 

marketing year, feed was approximately 40 percent of U.S. corn production, food, seed, and 

industrial uses were approximately 45 percent, and exports the remaining 15 percent (USDAERS, 2011c). Seeds constituted approximately 1.7 percent of domestic corn production, with 5.6 

percent being used for high fructose corn syrup, glucose and dextrose, and corn starch (USDAERS, 2010c). 

Ethanol production from corn represented a much smaller share of demand before the Energy 

Policy Act of 2005 established a 7.5-billion-gallon target for renewable fuels in gasoline by 2012 

and a tax credit of 51 cents per gallon of ethanol blended with gasoline (Westcott, 2007). The 

recent expansion in demand for corn for ethanol production is projected to slow, however, 
57

reflecting moderate growth of gasoline consumption in the U.S. and limited potential for further 

market penetration. The share of corn use for ethanol is expected to remain at 36 percent and the 

share of exports to grow to 16 to 17 percent. Prices are projected to remain historically high. 

According to the USDA, acreage is projected to increase to 92 million by 2020 from 88 million 

in 2010, approximately a 4.5 percent increase, at the expense of other crop acreage (USDA-ERS, 

2011c). 

U.S. corn production benefits from various Federal programs, including crop insurance, countercyclical payments, marketing loans, and the Average Crop Revenue Election program. 

Additionally, ethanol imports are discouraged through an import tariff of 54 cents per gallon. 

Corn is grown in all of the continental U.S., but more than 90 percent is grown in the top 18 

producing states, mostly in the Midwest and Great Plains. The states with the most harvested 

acres of corn for grains and silage in the 2007 Agricultural Census were Iowa, Illinois, Nebraska, 

Minnesota, and Indiana (USDA, 2009). 

Because MON87460 is expected to reduce yield loss under water-limited conditions compared to 

conventional corn, it would most likely be adopted in areas subject to frequent moderate water 

deficit. It is also possible that irrigated corn-producing areas would benefit if adoption of 

MON87460 would allow reduction of irrigation costs with net returns. These two conditions 

may be found in Western drylands. Areas that currently do not produce corn are less likely to 

benefit because they reveal fewer competitive advantages for corn production, although the 

possibility of expansion of corn acreage has been assessed earlier. 

Corn production requires a steady supply of moisture totaling approximately 20 inches during the 

growing season to achieve maximum yields. Many U.S. states have average annual precipitation 

below 20 inches per year. Among those states, those with most non-irrigated acreage of corn 

harvested are North Dakota, Colorado, Montana, New Mexico, and Wyoming. States with 

average annual precipitation between 20 and 30 inches per year could also benefit from 

MON87460, given variations in precipitation throughout the year and from one year to another. 

Among those states, those with most non-irrigated acreage of corn harvested are Minnesota, 

South Dakota, Nebraska, Kansas, and Texas (NOAA, 2010; USDA, 2009). States with annual 

precipitation of more than 30 inches per year also could also benefit. However, the increase in 

expected yields from adoption of MON87460 would be less during times of higher annual 

average precipitation and of lower variation of precipitation throughout the year (and in between 

years). Therefore, there would be fewer incentives for adoption of MON87460 in states with 

higher average annual precipitation. Of the 10 states identified above, all except Minnesota are 

in the Great Plains area of corn production, with Minnesota bordering this area in the Midwest. 

The states with the most irrigated acreage of corn harvested are Nebraska, Kansas, Texas, 

Colorado, and California (USDA, 2009). Of these, all but California are in the Great Plains area 

of corn production. In Texas and Colorado, the share of total irrigated crop acres (not just corn 

acres) that had diminished yields due to irrigation interruption in 2008 was more than a quarter of 

the total (USDA, 2008). 

Most of this section focuses on the states where MON87460 adoption would be expected to 

result in more impacts on local yields and crop-related farm income. The geographic borders of 

the analyzed region are a simplification intended to facilitate analysis and should not be 

interpreted rigidly; some states included in this region have portions with considerably higher 
58

annual average precipitation than others and portion of states not included in this regional focus 

also might have corn production under non-irrigated areas routinely subject to water shortages. 

In addition, climate change could impact areas of greater or lesser annual precipitation in the 

future. This regional focus, however, is intended to emphasize the potential for regionally 

differentiated impacts, noting that impacts on other corn-producing areas could be similar, but 

arguably of a lesser degree. 

There is no geographical difference in the U.S. among the areas of production of GE corn and 

areas of production of organic and non-GE corn. Although the demand for different types of 

corn depends on varietal traits that are often independent of the corn’s GE or non-GE quality, 

there is a niche market for non-GE food and feed in the U.S., as evidenced by private labeling 

initiatives (e.g., Non-GMO Project) that offer third-party product verification and labeling for 

non-GMO products (Non-GMO-Project, 2010). There also is a growing niche market for 

organic products in the U.S. Sales of organic products have been growing quickly, having grown 

from $1 billion in 1990 to $24.8 billion in 2009 and 5.1 percent between 2008 and 2009 (OTA, 

2010). To satisfy the demand for either organic or non-GE corn, producers have had to adopt 

specific production practices that have been widely used in the U.S. for more than a decade. 

However, in the case of organic corn production, there is some evidence that supply might be 

lagging behind demand (Greene et al., 2009). 

Corn seed production in the U.S. follows standards of varietal purity. The AOSCA offers a 

standard for production of non-GE corn seeds that allows for 1 percent presence of GE content 

(AOSCA, 2003). 

The affected domestic environment is defined as any land in the U.S. that is currently producing 

crops that could incorporate a corn rotation, as well as land that could be converted from inactive 

cropland to active cropland, and land currently in the CRP that could be removed from the 

program and farmed. Within this affected environment, adoption of MON87460 would be more 

likely in some geographic areas than in others. Therefore, the domestic economic environment 

most likely affected by a determination of nonregulated status of MON87460 would be the area 

of its adoption. To the extent MON87460 adoption allows for increased returns from corn 

production, a determination of nonregulated status of MON87460 could increase the supply of 

corn and corn-related farm income. 

Because it is a GE crop, the potential for unintended presence in non-GE corn fields could impact 

marketing non-GE and organic corn. 

4.8.1.1 No Action Alternative: Domestic Economic Environment 

Under the No Action Alternative, any potential increase in corn production due to the decreased 

yield loss under water-limited conditions offered by MON87460 would not be realized. It 

should be noted that demand for U.S. corn is projected to remain strong due mostly to the 

increases in global demand (exports) and the maintenance of incentives for use of ethanol. 

4.8.1.2 Preferred Alternative: Domestic Economic Environment 

Varieties of Drought Tolerant Corn Available 
59

A determination of nonregulated status of MON87460 would allow the commercialization of a 

GE corn variety that is expected to reduce yield loss by six percent or more under water-limited 

conditions compared to conventional corn (Monsanto, 2010). There appears to be two types of 

drought tolerant corn seed available: the incrementally improving hybrids and some that are 

more advanced, which are just making an appearance in the marketplace. Regionally marketed 

conventional traits apparently have similar drought tolerant properties to those offered by 

MON87460. To some extent, all U.S. corn varieties have been becoming more drought resistant 

over time (Yu and Babcock, 2010), but others have been specially selected for drought tolerance. 

A current offering of seed might include 22% of the options with a high drought tolerance rating 

(for maturities 79-119) (Asgrow and DeKalb, 2011). Some companies currently offer corn seed 

that expresses exceptional drought tolerant characteristics, which are generated without using 

transgenic techniques (e.g., Optimum Aquamax, 5% yield advantage under water stress, limited 

availability in 2011 season) (Pioneer, 2010, 2011a, 2011b). The impacts of a determination of 

nonregulated status of MON87460 would likely not be different from these other existing seed 

options. 

Analysis of Increases in Corn Acreage 

Beyond increased expected yields in areas currently producing corn and subject to water-limited 

conditions, an increase in corn acreage (without expansion necessarily to new agricultural areas) 

is theoretically possible due to the increased expected returns to corn production. An estimate 

depends on the expectations regarding rainfall, decreased yields in conventional corn during 

water-limited conditions, decreased yield loss provided by MON87460 during water-limited 

conditions, the impact of yields on returns, the elasticity of corn acreage to increased returns, and 

the extent of adoption of MON87460. Because of uncertainties regarding each of these factors, a 

reliable estimate is not possible. However, for illustrative purposes, a numerical exercise is 

provided below for a hypothetical scenario. The variables assumed in this exercise should not be 

considered to be those APHIS expects to actually occur, but rather reasonable assumptions, given 

the illustrative purpose of this exercise and current available information. 

Assumptions: 

1. Yields of conventional varieties are expected to be 15 percent lower during waterlimited conditions, as the minimum assumed in the Monsanto variety trials (Monsanto, 

2010) (i.e., yield under water-limited conditions would be 85% of the yield under 

adequate water conditions). 

2. MON87460 is expected to provide a 6 percent reduction in yield losses under those 

circumstances (Monsanto, 2010). 

3. Farmers perceived a 50 percent chance of water shortages (i.e., half the planted corn is 

subjected to water-limited conditions and half is under adequate water conditions) 

 Expected yield returns in corn farming would increase as estimated below: 

Expected yield with conventional variety = Yh × 0.5 + Yl × 0.5 

 = Yh x 0.5 + 0.85Yh × 0.5 
60

 = 1.85Yh × 0.5 = 0.925Yh 

Expected yield with DT Corn = Yh × 0.5 + Yl x 1.06 × 0.5 

 = Yh × 0.5 + 0.85Yh x 1.06 × 0.5 

 = 1.901Yh × 0.5 = 0.9505Yh 

Increased expected yield with DT Corn = 

(Expected yield with DT corn- Expected yield with conventional variety) 

(Expected yield with conventional variety) 

 = (0.9505Yh - 0.925Yh) ⁄ 0.925Yh 

 = (0.9505 - 0.925)Yh ⁄ 0.925Yh = 2.76% 

Where: 

Yh - yield under adequate water conditions; and 

 Yl - yield under water shortage (Yl = 0.85Yh).__________________________________ 

Based on the above calculations, the expected yield increase using MON87460 corn would be 

2.76%. Based on USDA (USDA-ERS, 2010b) production cost and return estimates, a 2.76 

percent increase in yields would translate to an approximate 5.5 percent increase in net returns 

(i.e., from USDA data, yield/net returns = 0.5, then assuming the same ratio or 0.5 = (2.76)/(% 

increase in net returns), a 2.76 percent increase in yields corresponds to 5.5 percent increase in 

net returns). Available estimates of elasticity of corn acreage to expected returns are up to 0.48 

for the U.S plains (FAPRI, 2004), suggesting a 5.5 percent increase in returns would translate to 

a 2.6 percent increase in corn acreage (i.e., percent increase in corn acreage = 0.48 x 5.5 percent 

increase in net returns) in those areas where returns from adoption of MON87460 are expected to 

increase. Taking non-irrigated harvest corn acreage from the 2007 Agricultural Census of the 10 

previously mentioned states most likely to benefit from MON87460 adoption as a basis, a 2.6 

percent increase in corn acreage would result in 572 thousand acres of added corn fields (2.6 

percent x 22 million acres), or approximately 0.65 percent of the current corn acreage in the U.S. 

Because available estimates of the elasticity of agricultural land use to increased returns in 

agriculture are very low (Barr et al., 2010), this increase in acreage would be almost entirely 

observed on land converted from other crop production, rather than from land currently not in 

agricultural use (including CRP land). Because the areas of corn expansion would be 

presumably areas subject to yield loss under water shortages, a 0.65 percent increase in corn 

acreage would likely have a less than proportional impact on corn production. 

Again, the above numerical exercise should not be interpreted as an estimate, but rather as an 

illustration of the magnitude of the potential impact, given the assumptions. If the number of 
61

farms potentially benefiting from MON87460 adoption is substantially larger, for example, the 

impact on corn acreage also could be larger. However, given the magnitude of impacts 

illustrated by the exercise above, the impact of a determination of nonregulated status of 

MON87460 on corn acreage is expected to be minor. 

Locations of Increased Farm Income 

Corn-related farm incomes could increase in areas that adopt MON87460. For example, using 

the same hypothetical scenario described above and based on USDA (2010b) production cost 

and return estimates, a possible 2.76 percent increase in yields would translate to an approximate 

5.5 percent increase in net returns. The impact of such an increase in returns would be greater for 

states where farms represent a greater share of state GDP and where corn represents a greater 

share of crop acreage, such as Nebraska and South Dakota. 

Impacts on Overall Farm Income 

Increases in corn-related farm incomes would have a less than proportional impact on farm 

household incomes because of the importance of other sources of income for corn-farm 

households. An analysis of the USDA 2001 Agricultural Resource Management Survey 

suggests that almost all the income of rural residence corn farmers and most of the income of 

intermediate corn farmers (those with less than $250,000 in annual farm sales) was from off-farm 

sources. Only on commercial corn farms (those with more than $250,000 in annual farm sales) 

was crop-related farm income most of total income, a large share also being from direct 

government payments. In all cases, corn-related income was a very small (typically negative) 

share of the total income of corn-farm households (McBride, 2005). Based on this information, 

impacts on overall farm income due to a determination of nonregulated status of MON87460 are 

expected to be negligible. 

Impacts on Irrigation and Water Use with MON87460 

Regarding the impact of MON87460 on water use in irrigated corn, no data has been provided or 

is available to assess the extent of savings in water costs that might be stimulated following the 

adoption of MON87460. Indeed, the observations presented in the petition indicate that expected 

maximum yield in the variety depends on attaining sufficient water (Monsanto, 2010). 

MON87460 would be used to provide a safeguard against unexpected interruptions in water for 

irrigation, but would certainly be used by growers if reductions in irrigation prove possible or 

that MON87460 was otherwise useful in some circumstances to reduce use of irrigation water. 

At present, irrigation sparing capacity of MON87460 has not been demonstrated, and 

expectations for savings on irrigation are not consistent with current experimental observations 

provided by the applicant (Monsanto, 2010). 

Additional Impacts 

The largest impact of the product will likely be that growers experience reduced yield losses with 

MON87460 in some years that are less than those incurred by planting non-drought tolerant corn 

varieties. Another impact is that crop insurance costs may be reduced if growing MON87460, 

since the Federal Crop Insurance Corporation has historically offered growers who purchased 

certain biotech varieties with lower rates (USDA, 2011a, 2011b). If indeed better drought 
62

performance was accomplished by this product, federal crop insurance underwriters could have 

reason to offer a future policy endorsement. An increase in land values as a result of planting 

MON87460 is also possible, although there is not enough information to assess these potential 

impacts. 

Impacts on Organic and non-GE Corn Producers by MON87460 

Non-GE, organic, and GE corn are currently grown in generally the same areas. Incurred 

economic impacts on organic farming from conventional GE farming have been suggested to 

include those on process, on sales potential, and on inferred salability. APHIS concludes that 

overall economic impacts of GE corn on organic corn production are likely inconsequential for 

the following reasons: 

 The unintended presence of a small percentage of GE content in crops produced under 

organic farming does not lead to the loss of organic certification of the organic operation 

or property (see 2.1.2.3 Organic Corn Production Systems; 4.3.3.2 Preferred Alternative: 

Organic). 

 USDA-APHIS acknowledges that some organic buyers or seed or of produce may 

require the grower to assay seed for the presence of transgenes. Financial costs to both 

organic and non-GE corn farmers thus may include testing for the presence of GE 

material. As is clear from organic production in general, there are many sources of 

additional input for organic crops compared to conventional ones, but the increased 

wholesale and retail cost of organic products should adequately compensate for additional 

costs to the organic grower (McBride, 2008). 

 Some growers cite concerns that buyers of organic seed or produce may avoid purchase 

of their agricultural output if the grower’s production farm is too close to conventional 

agricultural farms, even if actual admixture is not detected. As noted earlier in this EA 

(4.3.3.2 Preferred Alternative: Organic), organic agriculture has continued to expand, 

responding to increasing demand for more products, and in the case of organic corn, 

supply may considerably lag behind demand (see 2.6.1 Domestic and Trade Economic 

Environment). Criteria for description as organic has been regularized by third-party 

product verification and labeling (Non-GMO-Project, 2010) so that acceptable thresholds 

of unintentional admixture of GE can be identified, and exact standards agreed by 

producers and buyers. Consequently, the incidental presence of small amounts of GE in 

organic products is not a disqualifying attribute for many organic buyers. 

Additionally, gene flow from MON87460 resulting in admixture into organic or non-GE crops 

would not be any more likely than gene flow from currently available GE varieties especially 

given the prevalence of so many other GE traits in the corn seed marketplace. To the extent that 

a determination of nonregulated status of MON87460 would contribute to increased GE corn 

acreage, the likelihood of proximity of either organic or non-GE corn farms to GE corn farms 

could potentially increase as well. However, as previously analyzed, current projections for 

increases in corn acreage under the No Action Alternative are about 4.5 percent between 2009 

and 2020. As demonstrated by the numerical exercise above, the magnitude of impact of a 

determination of nonregulated status of MON87460 on corn acreage could be substantially less 

than that of other current factors (such as higher prices for corn commodities) that encourage 
63

planting of many other GE varieties. Thus, these other factors are more likely to result in 

increases of corn acreage. 

An accurate estimate of the increase in U.S. corn production would depend on determining the 

degree of adoption, on the actual impact of MON87460 to yields under water-limited conditions, 

and the degree of water shortage in any given year. However, USDA-APHIS assesses that these 

three factors will be low, so that the overall impact of a determination of nonregulated status of 

MON87460 on U.S. corn production is expected to be minor. 

4.8.2 Trade Economic Environment 

The U.S. is the largest world exporter of corn. This section describes potential impacts on U.S. 

trade flows from a determination of nonregulated status of MON87460. 

In the 2008/9 marketing year, corn exports accounted for approximately 15 percent of the total 

U.S. corn use behind feed, ethanol production, and food and seed (USDA-ERS, 2011c). Because 

exports are a relatively small share of U.S. corn use but the U.S. is the largest exporter of corn, 

U.S. domestic markets have a large influence on international corn prices (USDA ERS 2009b). 

In 2009, total exports of corn valued approximately $9 billion, with less than 2.5 percent of this 

being for seed. The primary countries of destination for U.S. corn exports in 2009 were Japan, 

Mexico, South Korea, Taiwan, Canada, and Egypt, with more than 75 percent of the total 

(USDA-FAS, 2010a). The primary seed export destinations are Canada and Mexico. 

The U.S. is by far a net exporter of corn with imports in 2009 valued less than $300 million, 

almost 90 percent of this coming from Chile, Argentina, and Canada (USDA FAS 2010a, code 

1005 of the Harmonized System). 

About 60 percent of the world trade in coarse grains (corn, barley, sorghum, rye, oats, millet, and 

mixed grains) is for feed and 75 percent of the coarse grains trade is corn. Trade in feed for 

livestock has been a driver of trade in corn (USDA-ERS, 2011c). Japan is the world’s largest 

corn importer, typically followed by South Korea, Mexico, Egypt, and Taiwan (USDA-FAS, 

2010b). Between the trade years (October through September) of 2003/4 through 2007/8, the 

U.S. share of world corn exports averaged 60 percent, the second largest exporter being 

Argentina, with China’s exports being occasionally important yet unpredictable, and largely a 

function of internal policies (USDA, 2009). 

The primary U.S. corn export destinations are also the largest world importers of corn and do not 

seem to have major barriers for importing GE products. In Japan there are no restrictions for 

import of genetically engineered varieties that have been approved for commercialization in 

Japan. In the case of genetically engineered varieties not yet approved in Japan a 1 percent 

presence in feed is still allowed, as long as it has been approved by an exporting country with 

safety assessments equivalent to Japan’s. There is no restriction after approval. Labeling is 

mandatory for GE food when the GE content can be detected and if the GE ingredient is one of 

the first three ingredients of a product and accounts for more than 5 percent of its total weight 

(Greuere, 2006). Mexico imports and consumes regularly existing varieties of GE corn (USDAFAS, 2008a). South Korea has similar approval processes as Japan and requires labeling for GE 

animal feed (USDA-FAS, 2008b). Taiwan requires labeling for products containing more than 5 
64

percent GE content (USDA-FAS, 2008c). Egypt is a large consumer of GE crops, including 

corn, soybeans, and vegetable oils (USDA-FAS, 2006). 

While detailed data are not readily available for U.S. organic crop exports, the USDA Foreign 

Agricultural Service estimates that exports of all organic products in 2009 totaled $1.7 billion 

(USDA-ERS, 2011b; USDA-FAS, 2011). Official U.S. data are currently limited by the lack of 

international trade codes for organic products; thus far, only Canada and the U.S. have 

established trade codes for organic products (USDA-FAS, 2011). However, given the large 

demand for non-organic grain corn on the international market, it is likely that U.S. organic trade 

is a small contributor to total corn trade. 

The affected trade economic is defined as those countries with which the U.S. engages in corn 

feed, seed and food trade. Therefore, the trade economic environment most likely affected by a 

determination of nonregulated status of MON87460 would be those countries who import 

MON87460 feed, seed, and food. 

4.8.2.1 No Action Alternative: Trade Economic Environment 

The USDA provides projections for the agricultural sector through 2020 (USDA-ERS, 2011c). 

World trade in corn is projected to increase 30 percent between the 2008/9 trade year and the 

2019/20 trade year. The U.S. share of that trade is projected to remain slightly below 60 percent, 

with U.S. corn exports therefore increasing at a rate also close to 30 percent. Although, many 

countries are investing in biofuel production capacity, several feedstocks are used in addition to 

corn, such as sugarcane for ethanol and rapeseed and soybean oil for biodiesel. Feed for 

livestock is projected to remain the main driver of corn trade. 

Under the No Action Alternative, any potential increase in corn seed exports with a 

determination of nonregulated status of MON87460 in the U.S. would not be realized. 

4.8.2.2 Preferred Alternative: Trade Economic Environment 

Although the primary U.S. corn export destinations do not present major barriers to trade in GE 

products, Monsanto would need to obtain MON87460 approval in destination countries before 

commercialization to avoid adversely affecting current trade flows. Monsanto recognizes this in 

its petition and states its intention to seek approval for MON87460 in primary U.S. export 

destinations with functioning regulatory systems before commercialization in the U.S. 

(Monsanto, 2010). Requests for approvals have been submitted to several markets, and Canada 

had approved the product for food, feed and cultivation, and Australia and New Zealand have 

approved it for food use. 

MON87460 seed could be of particular interest to parts of the world where corn production 

suffers from water-limited conditions. To the extent this interest translates to demand for U.S. 

MON87460 seed as a result of a determination of nonregulated status of MON87460, there could 

be a potential for increased corn seed exports. Because corn seed exports are a small share of 

total U.S. corn exports, this impact is expected to be minor or negligible. Corn from this foreign 

production could potentially enhance production in drought stressed locations in other countries. 

 
65

5 CUMULATIVE IMPACTS 

5.1 Assumptions used for Cumulative Impacts 

A cumulative impact may be an effect on the environment which results from the incremental 

impact of the proposed action when added to other past, present, and reasonably foreseeable 

future actions. 

Cultivation of stacked varieties, those crop varieties that may contain more than one trait, 

are currently found in the marketplace and in agricultural production. In the event APHIS 

reaches a determination of nonregulated status, MON87460 may be combined with non-GE 

and GE corn varieties by traditional breeding techniques. APHIS’ regulations at 7 CFR Part 

340 do not provide for Agency oversight of GE corn varieties that are no longer subject to the 

plant pest provisions of the Plant Protection Act and 7 CFR part 340, nor over stacked varieties 

combining GE varieties that are no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340 unless it can be positively shown that such stacked 

varieties were to pose a likely plant pest risk. 

There is no guarantee that MON87460 will be stacked with any particular non-GE or GE corn 

varieties that are no longer subject to the plant pest provisions of the Plant Protection Act and 

7 CFR part 340, as company plans and market demands play a significant role in those 

business decisions. Predicting all potential combinations of stacked varieties that could be 

created using both non-GE and GE corn varieties that are no longer subject to the plant pest 

provisions of the Plant Protection Act and 7 CFR part 340 is hypothetical and purely 

speculative. 

GE corn varieties are planted on the majority of corn acres in the U.S. (88 percent of acreage in 

2011) (USDA-ERS, 2010a; USDA-NASS, 2011a). Several states in the target range for 

MON87460 also demonstrate this trend, where adoption rates range from 87 percent to 97 

percent of all corn varieties planted in surveyed states (USDA-NASS, 2011a). These GE corn 

varieties were previously determined to pose no significant impact on the human environment, 

and are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act. These GE corn varieties include herbicide tolerant (e.g., 

glyphosate tolerant), insect resistant (e.g., Bt protein), or stacked varieties (e.g., glyphosate 

tolerant and Bt protein) (USDA-APHIS, 2011). Based on information detailed in the Monsanto 

petition (Monsanto, 2010) and increasing adoption of GE corn varieties with stacked traits on 

both national and regional scales (USDA-ERS, 2010a), it is reasonable to foresee that 

MON87460 will be stacked with herbicide-tolerant and/or insect-resistant traits. Consequently, 

USDA-APHIS will assume that MON87460 will be stacked with commercially available GE 

traits in this cumulative impacts analysis. 

5.2 Cumulative Impacts: Current Acreage and U.S. Cultivation Range 

Stacked corn varieties with the MON87460 trait are unlikely to significantly impact current 

agricultural corn production strategies. With regard to projected increases in domestic corn 

production (USDA-ERS, 2011c), acreage shifts away from other crops (USDA-ERS, 2010b, 

2011c) are likely to continue providing primary sources of additional land for corn cultivation, 

rather than the conversion of non-arable or conservation land (USDA-ERS, 2011a). As 
66

previously discussed, farm-level decisions to increase corn production reflect a sustained increase 

in corn demand and reactive government policies on agricultural commodity production 

(Claassen and Tegene, 1999; Plantinga et al., 2001). These external market forces and 

government policies strongly influence farmer land-use decisions and will likely continue 

excerpting a strong influence independently of any particular GE corn variety (e.g., MON87460 

stacked variety). Additionally, stacked corn varieties with the MON87460 trait are also unlikely 

to enable cultivation of corn in novel and non-arable areas based on the influence of 

biotechnology-derived traits on corn physiology. With regard to corn growth, development, and 

abiotic stress responses (heat, cold, and salt stress responses), MON87460 is not significantly 

different from currently-available corn varieties under both water-sufficient and water-limited 

conditions (USDA-APHIS, 2010). The magnitude of drought tolerance in MON87460 is 

observed in other regionally adapted, drought tolerant corn varieties (Monsanto, 2010). 

Commercialized GE corn varieties and their progeny were also determined to be similar to 

conventional corn varieties with respect to growth and development (USDA-APHIS, 2011). 

Thus, the breeding of MON87460 with other GE herbicide-tolerant and/or insect-resistant 

varieties is unlikely to produce a corn plant with a significantly different cultivation range, as 

these individual corn varieties did not in themselves possess traits that would enable an increased 

cultivation range. 

5.3 Cumulative Impacts: Cropping Practices 

With respect to corn cropping practices, stacked corn varieties with MON87460 are unlikely to 

pose a significant cumulative impact on corn management strategies related to tillage, irrigation, 

and pesticide/fertilizer application, and crop rotation. Corn management strategies are generally 

dependent on the corn variety cultivated; consequently, due to the large adoption of GE corn 

varieties on both a national and regional scale (e.g., Great Plains dryland region) (USDA-NASS, 

2011a), the majority of these management strategies reflect those that are suitable for herbicidetolerant or insect-resistant corn varieties. The presence of any herbicide-tolerant trait will 

continue to encourage conservation tillage strategies that are already adopted as an integral part 

of corn cultivation practices. Additionally, established methods of irrigation and fertilizer 

application are unlikely to change in the presence of stacked corn varieties with the MON87460 

trait, as this corn hybrid is likely to require these similar moisture and nutritional requirements as 

its parent varieties. Stacked corn varieties with MON87460 are likely to mitigate any potential 

shifts in pesticide use (detailed in Chapter 4.3.2 of this EA), as commonly-adopted pesticide 

application strategies is likely to be applicable to any stacked corn variety with MON87460 due 

to the presence of existing herbicide-tolerant and/or insect-resistant traits. In its target range of 

the Great Plains dryland region, stacked corn varieties with MON87460 will likely represent a 

replacement product rather than a supplemental product; thus, as a replacement product for 

currently cultivated corn varieties possessing herbicide-tolerant and/or insect resistant traits, no 

significant increases in fertilizer/pesticide/irrigation beyond that associated with additional corn 

production (USDA-ERS, 2011c) is anticipated, due to the adoption of cropping practices already 

in use. With respect to rotational strategy, shifts toward corn-corn rotations are already occurring 

due to farm profitability associated with increased international and domestic corn demand; corn 

varieties stacked with MON87460 are unlikely to significantly influence these external market 

forces, and thus, will unlikely change the increasing trend toward corn-corn rotation in the 

foreseeable future (USDA-ERS, 2011a). 
67

5.4 Cumulative Impacts: Organic 

Organic corn production is unlikely to experience a significant cumulative impact due to the 

presence of stacked corn varieties with MON87460. Production of GE corn and organic corn has 

increased in the recent past and will likely continue into the foreseeable future, reflecting an 

increasing demand for corn derived from both production strategies. Organic corn production 

and acreage has increased in spite of concurrent adoption in GE corn production methods 

(USDA-ERS, 2010a, 2010d), suggesting that current methods of isolation and identity 

preservation (Kuepper, 2002; Kuepper et al., 2007) are sufficient to limit gene flow between GE 

and organic corn. Stacked corn varieties with MON87460 is intended as a replacement product 

for other stacked corn varieties in its intended target region; thus, GE corn acreage is not 

anticipated to significantly increase corn acreage beyond projected values, as it will replace and 

not supplement hybrid GE corn varieties already cultivated. Furthermore, reproductive 

characteristics of MON87460 does not differ from commercially-available corn varieties 

(USDA-APHIS, 2010); additionally, the reproductive characteristics of GE corn varieties that 

have previously been determined to no longer be subject to the regulatory requirements of 7 CFR 

part 340 or the plant pest provisions of the Plant Protection Act also do not differ from 

commercially-available varieties (USDA-APHIS, 2011). Thus, any stacked corn variety 

containing MON87460 is also unlikely to display any significant differences in pollen viability or 

pollen number, further suggesting that current methods of isolation and identity preservation are 

likely to be sufficient to limit gene flow between GE and organic corn. The presence of 

inadvertent GE material in organic corn does not preclude USDA organic certification, as it is a 

processed-based system (USDA-AMS, 2011). Additionally, third-party verification of organic 

corn based on a threshold presence of GE material is already practiced for the benefit of organic 

retailers (Non-GMO-Project, 2010) and is unlikely to be impacted by any corn variety stacked 

with MON87460. 

5.5 Cumulative Impacts: Water Usage and Water Quality 

With regard to water usage and water quality, stacked corn varieties with MON87460 is not 

anticipated to pose any significant cumulative impact. MON87460 has been determined to share 

similar moisture requirements with conventional corn varieties; in addition, the mechanism of 

drought tolerance in MON87460 has been attributed to improvements in water use efficiency 

rather than increased water uptake (USDA-APHIS, 2010). There is no reason to suspect that 

commercially-available GE corn varieties require more moisture or possess increased water 

uptake than conventional corn varieties, as these GE corn varieties were engineered to tolerate 

herbicide application or resist insect herbivory. Thus, water usage is not anticipated to be 

significantly different in hybrid corn varieties possessing MON87460 and other commerciallyavailable GE traits. 

As discussed in Chapter 5.3 of this EA, stacked corn varieties with MON87460 will permit the 

continued use of established and common corn agronomic practices. This includes the continued 

use of conservation tillage strategies that are widely-practiced in U.S. corn production systems. 

The relationship between conservation tillage and reduced soil erosion is well documented, as is 

the correlation between reduced soil erosion and reduced agricultural NPS pollution. Stacked 

corn varieties with MON87460 will enable the continued use of conservation strategies, thus 
68

making it unlikely that this stacked corn variety with MON87460 will significantly change soil 

quality and the NPS pollution that directly influences water quality. 

5.6 Cumulative Impacts: Soil 

The soil environment in and around corn fields is complex, and rich in microorganisms and 

arthropods. Specific crop management practices used for GE plants, such as pesticide 

applications, tillage, and application of inorganic and organic fertilizers can alter soils and the 

microbial and arthropod populations associated with it. As discussed in Chapter 5.3 of this EA, 

the stacking of MON87460 with herbicide-tolerant/insect-resistant traits would represent a 

replacement product for GE corn varieties that possess the same herbicide-tolerant/insectresistant traits, due to similarities in management practices. Due to similar management practices 

between corn varieties stacked with MON87460 and current commercially-available corn 

hybrids, it is unlikely that a cumulative impact on soil quality would occur following a 

determination of nonregulated status of MON87460. 

5.7 Cumulative Impacts: Air Quality 

Air quality may be affected by a variety of agricultural-related activities, including smoke from 

agricultural burning, tillage, traffic and harvest emissions, pesticide drift from spraying, and 

nitrous oxide emissions from the use of nitrogen fertilizers (Aneja et al., 2009; Hoeft et al., 

2000). As discussed in Chapter 5.3 of this EA, the stacking of MON87460 with herbicidetolerant/insect-resistant traits would represent a replacement product for current GE corn varieties 

that possess the same herbicide-tolerant/insect-resistant traits, due to similarities in management 

practices. Due to similar management practices in agricultural practices between currentlyavailable GE corn varieties and corn varieties stacked with MON87460, it is unlikely that any 

significant cumulative impact on air quality would occur following a determination of 

nonregulated status of MON87460. 

5.8 Cumulative Impacts: Climate Change 

U.S. agricultural activities can directly contribute to the emission of GHG through the 

combustion of fossil fuels. Additionally, agricultural input strategies and management practices 

can affect soil quality and disturbance, and the degradation of agricultural residues in the field. 

As discussed in Chapter 5.3 of this EA, the stacking of MON87460 with herbicidetolerant/insect-resistant traits would represent a replacement product for current GE corn varieties 

that possess the same herbicide-tolerant/insect-resistant traits, due to similarities in management 

practices. Due to similar management practices in agricultural practices between currentlyavailable GE corn varieties and corn varieties stacked with MON87460, it is unlikely that any 

significant cumulative impact on climate change will occur, as agricultural practices that affect 

climate change will be similar between corn varieties stacked with MON87460 and the majority 

of corn that is currently cultivated. 

It is possible that climate change may affect corn cultivation areas in the U.S. For example, as 

projected by the U.S. Global Change Research Program (2009), the northern regions of the Great 

Plains may become wetter while the southern regions may become drier. However, these shifts 

are unlikely to uniquely affect stacked corn varieties with MON87460, as there is no reasonable 

expectation that this corn hybrid would require less moisture or possess a cultivation range that is 
69

significantly different than conventional corn. Additionally, climate change projections are often 

made on a large scale (e.g., 80-90 years), which makes an accurate determination of its effects 

difficult and uncertain. 

5.9 Cumulative Impacts: Animal Communities 

As discussed in Chapter 4.5.1 and 4.6 of this EA, both NPTII and CSPB do not represent 

proteins that can elicit a toxic or allergic response from animals. There is no reason to anticipate 

molecular changes to these proteins following the hybridization of MON87460 with 

commercially-available corn varieties. Additionally, there is also no reason to expect a 

significant cumulative impact from this stacked corn variety with MON87460, as it would 

contain common traits that have previously been determined to no longer be subject to the 

regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act (USDA-APHIS, 2011). As discussed in Chapter 5.3 of this EA, stacked corn varieties with 

MON87460 would represent replacement products to currently available GE corn varieties that 

contain herbicide-tolerant and insect-resistant traits. Consequently, management practices will 

remain similar between stacked corn varieties containing MON87460 and current GE corn 

varieties, indicating that there will be no increase in the application of herbicides and pesticides 

beyond the current baseline. 

5.10 Cumulative Impact: Plant Communities 

Neither MON87460 nor previous GE corn varieties pose a plant pest risk; thus the progeny of 

MON87460 and commercially-available GE corn varieties is unlikely to possess weedy 

characteristics or introgress into wild relatives (USDA-APHIS, 2010, 2011). This stacked corn 

variety with MON87460 is not expected to be invasive in natural environments, compete with 

native vegetation, or have any different effect on habitat than conventional corn. No biological 

differences are anticipated in reproductive characteristics as well, including pollen viability and 

morphology. This corn variety stacked with MON87460 is not expected to significantly differ 

from conventional corn varieties with regard to hybridization with wild relatives, as the same 

barriers between conventional corn and sexually compatible relatives will persist, such as 

differences in flowering time, geographical separation, and development factors (Galinat, 1988). 

Consequently, no cumulative impacts are anticipated on plant communities resulting from the 

stacking of MON87460 and commercially-available GE corn varieties, as both parent corn 

varieties and progeny are expected to not possess any plant pest risk. 

5.11 Cumulative Impacts: Biodiversity 

While biodiversity may decrease following the general return of CRP land back into corn 

production, a stacked corn variety containing MON87460 is unlikely to increase the low 

conversion that already exists, as described in Chapter 4.3 of this EA. Farm-level land-use 

decisions are complex and strongly influenced by external market forces and existing 

government policies/subsidies (Claassen and Tegene, 1999; Plantinga et al., 2001) that exist 

independently of any particular biotechnology-derived corn variety. Stacked corn varieties with 

MON87460 are unlikely to significantly impact these economic forces and government policies 

related to corn grain production; thus, stacked corn varieties with MON87460 is unlikely to 

significantly impact biodiversity. Interestingly, net CRP acreage often mirrored that of total corn 

acreage from 1988 – 2010 (Figure 5), further suggesting a disconnect between corn production 
70

and CRP acreage. Additionally, stacked corn varieties with MON87460 are unlikely to 

significantly affect biodiversity, as biotechnology-derived proteins from both parent varieties 

(MON87460 and proteins related to herbicide-tolerance and/or insect resistance) are generally 

thought of as safe, with very little toxic effect on non-target organisms (USDA-APHIS, 2011). 

5.12 Cumulative Impacts: Gene Flow 

As described in the USDA-APHIS PPRA for MON87460, no significant differences are 

observed in pollen viability, pollen morphology, or seed dormancy (USDA-APHIS, 2010). 

Additionally, the GE corn varieties that MON87460 are likely to be stacked with (i.e., herbicidetolerant or insect-resistant traits) have been previously analyzed by USDA-APHIS and found to 

share similar reproductive characteristics with conventional corn (USDA-APHIS, 2011). The 

stacking of MON87460 and corn varieties no longer subject to the regulatory requirements of 7 

CFR part 340 or the plant pest provisions of the Plant Protection Act would not be anticipated to 

significantly alter reproductive characteristics relative to those of conventional corn varieties. 

Consequently, the barriers that exist between different corn varieties and sexually-compatible 

wild relatives would likely be shared with stacked corn varieties with MON87460, such as 

differences in flowering time, geographical separation, and development factors (Galinat, 1988). 

5.13 Cumulative Impacts: Public Health 

Stacked corn varieties with MON87460 are unlikely to significantly affect public health. As 

previously discussed in Chapter 4.6 and 4.7 of this EA, the NPTII and CSPB proteins in 

MON87460 are not likely to negatively affect public health. Additionally, the GE traits most 

prevalent in commercially-available corn varieties, such as herbicide-tolerance and insect 

resistance (Bt protein production), are also not likely to negatively affect public health, worker 

safety, and animal health (USDA-APHIS, 2011; USDA-BRS, 2006). Stacking these 

commercially-available traits with MON87460 to produce a new hybrid corn variety is not 

anticipated to negatively affect public health. Additionally, with respect to GE herbicidetolerance traits, glyphosate and glufosinate tolerance are the most prevalent traits in herbicidetolerant corn varieties. These two herbicides are generally considered safe, with low toxicity to 

humans, animals, and other non-target organisms. Application strategies of these two herbicides, 

or any other herbicide utilized in corn production, is unlikely to change in the presence of a 

stacked corn variety with MON87460. Furthermore, herbicide application is unlikely to show a 

net increase beyond that which can be expected with baseline increases in corn production, as 

any stacked corn variety with MON87460 is intended to be a replacement product rather than a 

supplemental product. Accordingly, herbicide application is unlikely to increase in areas 

growing a GE hybrid corn variety containing the MON87460 and herbicide-tolerant traits, as this 

particular variety is likely to replace herbicide-tolerant corn varieties that were already present, 

thus maintaining worker exposure to herbicide at present levels. 

5.14 Cumulative Impacts: Livestock Health 

Stacked corn varieties with MON87460 are unlikely to negatively impact livestock health 

through its use as animal feed. As discussed in Chapters 4.6 and 4.7 of this EA, both NPTII and 

CSPB do not represent toxic proteins or proteins that are capable of eliciting an allergic reaction; 

additionally, previous GE corn varieties (e.g., herbicide tolerance or insect resistance) that are no 

longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of 
71

the Plant Protection Act contain proteins that also are not toxic or elicit allergic reactions. 

Additionally, both MON87460 and current GE corn varieties are compositionally similar to 

conventional corn (USDA-APHIS, 2010, 2011). Consequently, stacking of MON87460 with 

herbicide-tolerant or insect-resistant traits is not expected to produce any novel proteins and only 

produce those proteins native to corn or those proteins that were determined to not pose any 

significant risk to livestock health. Any food, such as meat and milk, derived from animals that 

are fed corn varieties stacked with MON87460 are not expected to differ from food derived from 

animals fed conventional corn. 

5.15 Cumulative Impact: Domestic Economic Environment 

Through tax incentives and import tariffs and a federal mandate to increase the use of renewable 

fuels in gasoline, government policy has stimulated the growth of corn production for use in the 

production of ethanol. These policies are expected to continue in the foreseeable future and add 

to the incentive for corn production that would follow a determination of nonregulated status of 

MON87460. Other Federal policies such as Federal crop insurance, marketing loans, direct and 

counter-cyclical payments, and the Average Crop Revenue Election (ACRE) program may 

influence decisions of planting corn (as opposed to other crops or as opposed to non-agricultural 

uses of land) and add to the incentive for corn production that would follow a determination of 

nonregulated status of MON87460. These patterns occurred independently of a determination of 

nonregulatory status of MON87460 or any other GE corn variety, and it is unlikely that any 

cumulative impact would result from a stacked product consisting of MON87460 and other 

readily-available GE trait. 

5.16 Cumulative Impact: Trade Economic Environment 

APHIS identified a potential minor or negligible impact to trade economic environment as a 

result of the Preferred Alternative, which could contribute to a cumulative impact by another 

foreseeable action. MON87460 seed may be marketed abroad, potentially stacked with existing 

corn germplasm that exhibits similar traits; depending upon how much increase in corn 

production the variety may encourage, there may be incremental changes to foreign corn 

production. MON87460 could have impacts of unknown size on U.S. trade following a 

determination of nonregulated status of MON87460 in the U.S and abroad. Currently, requests 

for approvals for all purposes including planting have been submitted to Mexico and Canada but 

only Canada has approved the product for cultivation so far. However, according to the 

Monsanto petition, no product containing MON87460 will be commercialized until regulatory 

approval has been granted from all major U.S. corn-importing countries. 

   
72

6 THREATENED AND ENDANGERED SPECIES 

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching 

wildlife conservation laws ever enacted by any nation. Congress, on behalf of the American 

people, passed the ESA to prevent extinctions facing many species of fish, wildlife and plants. 

The purpose of the ESA is to conserve endangered and threatened species and the ecosystems on 

which they depend as key components of America’s heritage. To implement the ESA, the U.S. 

Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries 

Service (NMFS), other Federal, State, and local agencies, Tribes, non-governmental 

organizations, and private citizens. Before a plant or animal species can receive the protection 

provided by the ESA, it must first be added to the Federal list of threatened and endangered 

wildlife and plants. 

A species is added to the list when it is determined by the USFWS/NMFS to be endangered or 

threatened because of any of the following factors: 

 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. This process is used by APHIS to 

assist the program in fulfilling their obligations and responsibilities under Section 7 of the ESA 

for biotechnology regulatory actions. 

As part the environmental review process, APHIS thoroughly reviews GE product information 

and data to inform the ESA effects analysis and, if necessary, the biological assessment. For 

each transgene(s)/transgenic plant the following information, data, and questions are considered 

by APHIS: 

 A review of the biology, taxonomy, and weediness potential of the crop plant and its 

sexually compatible relatives; 

 Characterization of each transgene with respect to its structure and function and the 

nature of the organism from which it was obtained; 
73

 A determination of where the new transgene and its products (if any) are produced in 

the plant and their quantity; 

 A review of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact; 

 Determination of the concentrations of known plant toxicants (if any are known in the 

plant); and 

 Analysis to determine if the transgenic plant is sexually compatible with any 

threatened or endangered plant species (TES) or a host of any TES. 

APHIS analyzed the potential for effects from cultivation of MON87460 on Federally listed TES 

and species proposed for listing, as well as designated critical habitat and habitat proposed for 

designation, as required under Section 7 of the ESA. Direct effects are analyzed by considering 

the response that TES could have if exposed to MON87460. Indirect effects are those that 

could result from the use of MON87460 in corn production, would occur later in time, but are 

still reasonably certain to occur. Consideration is given for the potential of MON87460 to 

change the baseline habitat of TES including critical habitat. 

MON87460 will be grown on agricultural acres managed by growers in a manner similar to 

conventionally bred corn. MON87460 is not genetically engineered to produce a toxin or 

pesticide, and is not genetically engineered to be tolerant to an herbicide. Corn is an annual, 

wind-pollinated crop which lacks sexually compatible wild relatives (including threatened or 

endangered plant species) in the U.S., except for an occasional botanical garden specimen or 

small feral populations of Zea mexicana in Florida, Alabama and Maryland or Zea perennis in 

South Carolina (http://plants.usda.gov). Because corn itself is not sexually compatible with any 

listed plant species, there is no potential for a direct effect of MON87460 on TES plants. 

Because corn cannot naturalize and would not affect pollinators, there are no expected 

indirect effects of MON87460 on TES plants. 

Corn exhibits extremely limited seed dormancy, has no weedy characteristics, and volunteers are 

easily controlled. It is not capable of establishing persistent populations in unmanaged 

environments. As discussed previously, the presence of the CSPB protein in no way alters the 

weediness potential or gene flow potential of MON87460. Therefore, it is highly unlikely that 

MON87460 poses any more of a risk to threatened or endangered plant species than 

conventionally bred corn. 

Corn is a feed commonly provided to many livestock and consumed by wildlife (e.g., birds, deer, 

and rodents). The data presented in the petition suggests there is no difference in compositional and 

nutritional quality of MON87460 compared to conventional corn, apart from the presence of the 

CSPB and NPTII proteins. Based on the nature of the proteins, their known activity, and the 

characteristics of the donor organisms, the CSPB and NPTII proteins have a history of safety to 

organisms exposed at levels found in MON87460. Because there is no toxicity or allergenicity 

potential with MON87460, there would be no direct or indirect toxicity or allergenicity impacts 

on wildlife species that feed on corn or the associated biological food chain of organisms. A 

consultation with FDA was successfully completed for CSPB and NPTII proteins of MON87460 

(Appendix A), which demonstrated a lack of toxicity and allergenicity of MON87460 for human 

and animal consumption. Therefore, it is unlikely that MON87460 would affect threatened and 
74

endangered animal species, including animals such as insects, bats or birds that may be 

pollinators of TES plants. 

APHIS has considered whether approval of MON87460 will result in additional lands being 

converted to corn acreage, and consequently have possible impacts on T&E species. APHIS 

evaluates that corn acreage may well increase through 2020, but much of the land used will be 

at the expense of acreage planted to other crops on existing agricultural lands. Another source 

of additional lands are those in federal set aside programs, such as the Conservation Reserve 

Program. This program safeguards environmentally sensitive lands by planting native plants or 

long-term, resource-conserving cover crops that would control soil erosion, improve water and 

air quality, and enhance wildlife habitat. By taking land out of production under long term 

contracts, growers are given annual rental payments and cost-share assistance to promote these 

federal and state goals. The native and introduced vegetation provides habitat to wildlife, most 

notably birds (Delisle and Savidge, 1997; Johnson, 2005). Animals, including threatened and 

endangered species that could be affected by conversion of CRP land to MON87460 

production, use CRP land for food or cover. The animals that could be present in CRP areas 

would vary depending on the region and type of habitat. APHIS has concluded that although 

corn acreage could increase through 2020, no net increase in conversion of CRP lands for the 

reduced yield loss corn will likely occur. Some acreage may move in and out of CRP lands, but 

overall, APHIS has evaluated in this EA that neither this crop nor other corn crops will directly 

contribute to large-scale conversion of these reserved lands to agricultural lands. 

MON87460 is a corn variety that may reduce yield loss from drought, and displays no agronomic 

characteristics substantially different from existing commercial corn, and therefore is not weedy, 

nor likely to contribute to weediness of corn. Aside from expression of a common bacterial 

protein, no differences have been shown from similar corn varieties. Because no traits of 

MON87460 corn have been shown to be different from commodity corn, it is highly unlikely that 

MON87460 will have impacts different from other commodity corn varieties. Neither are 

impacts likely when MON87460 corn is combined through traditional breeding methods with 

APHIS- or EPA-approved insect-protected or herbicide tolerant traits. No direct or indirect 

adverse impacts were identified that would result from producing this corn, and APHIS 

concluded that there were also no cumulative impacts on any resources in agricultural or nonagricultural environment. 

After reviewing possible effects of a determination of nonregulated status of MON87460 corn, 

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. 

APHIS has considered the effect of MON87460 production on designated critical habitat or 

habitat proposed for designation and could identify no difference from effects that would occur 

from the production of other corn varieties. Additionally, cornfields are not designated critical 

habitat for any Federally threatened and endangered animal species listed under the ESA 

(USFWS, 2010). As discussed, APHIS has concluded that a determination of nonregulated 

status of MON87460 corn is unlikely to lead to large scale conversion of CRP land and 

consequent significant impacts on some CRP land that could become agricultural. 
75

Based on the above information, APHIS has concluded that a determination of nonregulated 

status of MON87460 would have no effect on Federally listed threatened or endangered species 

or species proposed for listing, nor would it affect designated critical habitat or habitat proposed 

for designation. Consequently, consultation with the USFWS or NMFS is not required for this 

action. 

 
76

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS 

7.1 Executive Orders with Domestic Implications 

The following executive orders require consideration of the potential impacts of the federal 

action to various segments of the population. 

 Executive Order (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. 

CEQ guidance for implementation of EO 12898 in the context of NEPA (Environmental Justice. 

Guidance Under the National Environmental Policy Act, December 10, 1997) identifies a 

minority population as an affected area where over 50 percent of the population belongs to a 

minority group or where the percentage presence of minority groups is meaningfully greater than 

in the general population. Geographically disperse groups with common conditions of 

environmental exposure may also be considered as a community subject to analysis for 

percentage presence of minority groups (e.g. agricultural workers). 

Table 8 shows that minority presence in the U.S. and in the states where MON87460 would 

likely be adopted to reduce the potential yield loss from water shortages. African Americans are 

represented in Texas at 11.4%, the highest percentage of all the affected states, while Hispanic 

Americans are represented at the highest in New Mexico at 44.9% and Texas at 36.5%. Although 

in New Mexico and Texas minorities are more than 50 percent of the population, in the ten states 

as a whole, minorities constitute only a slightly higher share of the total population than in the 

U.S. In all ten analyzed states, Hispanics and Native Americans are the minority groups whose 

presence surpasses their presence in the country as a whole: in both cases, their share in the ten 

analyzed states is approximately 1.7 times their share in the U.S. 

Table 8. Minority populations in states where MON87460 may be adopted, 2008. 

Location 

Total 

Population 

Percent of Total Population 

White 

Black or 

African 

American

Alaska 

Native or 

American 

Indian Asian

Native 

Hawaiian 

& Other 

Pacific 

Islander

Some 

Other 

Race 

Two 

or 

More 

Races 

Hispanic 

or 

Latinoa

Total 

Minoritiesb

U.S. 304,059,728 75.05% 12.36% 0.80% 4.41% 0.14% 4.93% 2.31% 15.42% 34.57% 

Colorado 4,939,456 84.74% 3.80% 0.97% 2.55% 0.11% 4.75% 3.08% 20.19% 29.22% 

Kansas 2,802,134 86.25% 5.62% 0.73% 2.14% 0.07% 2.48% 2.70% 9.08% 19.78% 
77

Table 8. Minority populations in states where MON87460 may be adopted, 2008. 

Location 

Total 

Population 

Percent of Total Population 

White 

Black or 

African 

American

Alaska 

Native or 

American 

Indian Asian

Native 

Hawaiian 

& Other 

Pacific 

Islander

Some 

Other 

Race 

Two 

or 

More 

Races 

Hispanic 

or 

Latinoa

Total 

Minoritiesb

Minnesota 5,220,393 88.14% 4.42% 1.05% 3.52% 0.01% 1.07% 1.80% 4.13% 14.69% 

Montana 967,440 89.62% 0.54% 6.05% 0.67% 0.07% 0.64% 2.41% 2.82% 12.14% 

Nebraska 1,783,432 88.91% 3.99% 0.76% 1.50% 0.05% 2.61% 2.18% 7.84% 15.82% 

New Mexico 1,984,356 73.45% 2.28% 9.22% 1.35% 0.04% 10.48% 3.19% 44.90% 58.45% 

North Dakota 641,481 91.00% 0.95% 5.30% 0.84% 0.04% 0.56% 1.30% 2.02% 10.21% 

South Dakota 804,194 87.10% 0.94% 8.17% 0.82% 0.03% 0.77% 2.17% 2.36% 13.96% 

Texas 24,326,974 73.87% 11.43% 0.50% 3.46% 0.08% 8.71% 1.95% 36.46% 52.78% 

Wyoming 532,668 91.87% 1.06% 2.04% 0.70% 0.03% 1.52% 2.77% 7.73% 13.34% 

Total of 

10 States 44,002,528 79.22% 7.95% 1.39% 2.92% 0.07% 6.27% 2.19% 26.06% 39.57% 

Source: U.S. Census Bureau, American Community Survey 2008 (USCB 2008). 

a

Individuals who identify themselves as Hispanic, Latino, or Spanish might be of any race; the sum of the other percentages 

under the “Percent of Total Population” columns plus the “Hispanic or Latino” column therefore does not equal 100 percent. 

b

The total minority population, for the purposes of this analysis, is the total population minus the non-Latino/Spanish/Hispanic

white population. 

Table 9: Minority farmer populations in states where MON87460 may be adopted, 2007.

Location 

Total farmer

population

Hispanic or 

Latino 

Percent of 

Total 

Alaska Native or 

American Indian 

Percent of 

Total 

U.S. 3,337,450 82,462 2.47% 55,889 1. 7% 

Colorado 60,684 2,610 4.30% 619 1.0% 

Kansas 97,150 780 0.80% 508 0.5% 

Minnesota 119,650 507 0.42% 413 0.4% 

Montana 46,903 345 0.74% 2,013 4.4% 

Nebraska 71,924 288 0.40% 63 0.1% 

New Mexico 32,109 8,904 27.73% 6,611 21.2% 

North Dakota 45,114 142 0.31% 503 1.1% 

South Dakota 46,710 196 0.42% 1,150 2.5% 

Texas 372,563 28,921 7.76% 3,604 1.0% 

Wyoming 18,522 256 1.38% 324 1.8% 

Total of 10 States 911,329 42,949 4.71% 15,808 1.7% 

Source: 2007 Census of Agriculture – State Data (USDA-NASS 2007b) 
78

To the extent that impacts of a determination of nonregulated status of MON87460 affect 

primarily farm households, Table 9 shows the presence of Hispanics and American Indians 

among farm operators (those who run the farm: owners or other). The highest percentage of 

Hispanic farmers is found in New Mexico at 27.7% and in Texas at 7.8% and the highest 

percentage of American Indian farmers is in New Mexico at 20.6% (Table 9). Although 

Hispanic operators are considerably more highly represented in the ten state region than in the 

country as a whole (1.9 times more), both Hispanics and American Indian operators comprise a 

much smaller share of farm operators than they are of the total population in the 10-state region: 

4.7 percent of operators are Hispanics and 1.7 percent are American Indian. 

A large percentage of agricultural workers in the U.S. are born in Mexico  75 percent in the 

2001/02 fiscal year (USDOL-(United-States-Department-of-Labor), 2005). A relatively small 

share, 14 percent, of all agricultural workers had a field crop as their primary crop in 2001/02, 

most agricultural workers being employed in fruit, vegetable, and horticultural crops (USDOL-

(United-States-Department-of-Labor), 2005). However, any impacts on agricultural workers 

would likely affect a considerably larger share of Hispanics than the share of Hispanics in the 

total population. 

CEQ guidance for implementation of EO 12898 in the context of NEPA (Environmental Justice. 

Guidance Under the National Environmental Policy Act, December 10, 1997) suggests an 

analysis based upon U.S. Census Bureau Current Population Reports, Series P-60 on Income and 

Poverty for identification of low-income populations. This data is derived from the American 

Community Survey done annually through a representative household sample. Table 10, below, 

shows that the share of population in poverty in the ten state region is only slightly higher than 

the share of the population in poverty in the country as a whole. 

Table 10: Low-income presence, 2008. 

Location Totala Low-Income

Low-Income 

Share of Total 

U.S. 296,184,480 39,108,422 13.20% 

Colorado 4,835,406 552,889 11.43% 

Kansas 2,716,652 307,478 11.32% 

Minnesota 5,090,468 490,911 9.64% 

Montana 942,874 139,707 14.82% 

Nebraska 1,727,276 186,727 10.81% 

New Mexico 1,941,428 332,769 17.14% 

North Dakota 615,412 73,622 11.96% 

South Dakota 774,737 96,490 12.45% 

Texas 23,727,821 3,760,431 15.85% 

Wyoming 518,368 48,776 9.41% 

Total of 10 States 42,890,442 5,989,800 13.97% 

Source: U.S. Census Bureau, American Community Survey 2008 (UCSB 2008). a

Universe is population for whom poverty status is determined 
79

With respect to farm households, in 2003, 11 percent of the U.S. population was below the U.S. 

Census Bureau poverty line, while 14 percent of farm households were poor. Offutt and 

Gundersen (2005) argue that the U.S. Census Bureau poverty line might not adequately capture 

poverty in farm households, given that it does not capture the volatility of farm income and the 

greater asset holdings of farm households. Under the USDA alternative concept of Limited 

Resource Farmer, 11 percent of farm households would fall under that category in 2003, while 

under the USDA ERS Low Income/Low Wealth concept, only 5 percent of farm households 

would be classified as such in that same year. 

The possibility of disproportionately high and adverse human health and environmental effects 

depends on the existence in the affected area of minority or low-income populations and on the 

existence of significant impacts of a proposed alternative. If, for example, differential patterns of 

consumption of water or subsistence consumption of indigenous fish, vegetation, or wildlife are 

important to minority populations, low-income populations, or Indian tribes in the affected area, 

and some adverse impact existed on these resources, then these differential patterns of 

consumption could also lead to disproportionately high and adverse impacts. 

 Each alternative was analyzed with respect to EO 12898. Neither alternative is expected to have 

a disproportionate adverse effect on minorities or low-income populations. As presented in the 

Environmental Consequences section, no significant impacts were identified in the analyses 

conducted on human health, physical environment, or animal and plant communities. 

MON87460 has been shown to be no difference in compositional and nutritional quality 

compared to conventional corn, apart from the presence of the CSPB and NPTII proteins. The 

inserted genes (cspB and nptII) and proteins (CSPB and NPTII) expressed in MON87460 are not 

expected to be allergenic, toxic, or pathogenic in mammals. Both CSBP and NPII proteins have a 

history of safe consumption in the context of other food and feeds (FDA, 2010). This 

information establishes the safety of MON87460 and its products to humans, including 

minorities and low income populations who might be exposed to them through agricultural 

production and/or processing. No additional safety precautions would need to be taken. 

None of the impacts on agricultural practices expected to be associated with a determination of 

nonregulated status of MON87460 are expected to have a disproportionate adverse effect on 

minorities and low income populations. MON87460 is not genetically engineered to produce 

a toxin or pesticide, and is not genetically engineered to be tolerant to a herbicide. Due to the 

lack of pesticidal and herbicidal traits in MON87460, corn hybrid varieties may be produced 

with MON87460 and other nonregulated corn hybrids containing herbicide tolerant and/or 

pesticide traits. Thus, pesticide application practices and usage associated a determination of 

nonregulated status of MON87460 are not expected to change from the current trends for 

existing nonregulated GE corn. 

 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 
80

Federal agency to identify, assess, and address environmental health risks and safety 

risks that may disproportionately affect children. 

Each alternative was analyzed with respect to EO 13045. Neither alternative is expected to have 

a disproportionate adverse effect on children. As presented in the Environmental Consequences 

section, no significant impacts were identified in the analyses conducted on human health or the 

physical environment. 

None of the impacts on agricultural practices expected to be associated with a determination of 

nonregulated status of MON87460 are expected to have a disproportionate adverse effect on 

children. MON87460 is not genetically engineered to produce a toxin or pesticide, and is 

not genetically engineered to be tolerant to a herbicide. Due to the lack of pesticidal and 

herbicidal traits in MON87460, corn hybrid varieties may be produced with MON87460 and 

other nonregulated corn hybrids containing herbicide tolerant and/or pesticide traits. Thus, 

pesticide application practices and usage associated with a determination of nonregulated status 

of MON87460 are not expected to change from the current trends for existing nonregulated GE 

corn. 

The following executive order 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. 

All corn varieties, including MON87460, require human assistance to persist beyond a first 

generation of corn plants that may arise from spilled seed; they do not establish self-propagating 

populations. Corn does not possess traits that are characteristic of invasive species (Baker 1965, 

Keeler 1989, Galinat 1988). 

The following executive order 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 have, a measurable negative effect on migratory bird populations are 

directed to develop and implement, within two years, a Memorandum of 

Understanding (MOU) with the Fish and Wildlife Service that shall promote the 

conservation of migratory bird populations. 

Data submitted by the applicant has shown no difference in compositional and nutritional 

quality of MON87460 compared with other GE corn or non-GE corn, apart from the presence of 

the CSPB and NPTII proteins. MON87460 not expected to be allergenic, toxic, or pathogenic in 

mammals. Both CSBP and NPII proteins have a history of safe consumption in the context of 

other food and feeds (FDA, 2010). Additionally, the FDA has completed its food safety 

consultation on MON87460. Based on APHIS’ assessment of MON87460, it is unlikely that a 

determination of nonregulated status of MON87460 will have a negative effect on migratory bird 

populations. 
81

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 U.S., its territories, and possessions that result from actions being taken. 

APHIS has given this EO careful consideration and does not expect a significant environmental 

impact outside the U.S. in the event of a determination of nonregulated status of MON87460. 

All 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 APHIS determination of nonregulated status under 7 CFR Part 340. 

Any international trade of MON87460 subsequent to a determination of nonregulated status of 

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 PRA of living modified organisms (LMOs) was adopted at 

a meeting of the governing body of the IPPC as a supplement to an existing standard, 

International Standard for Phytosanitary Measure No. 11 (ISPM-11, Pest Risk Analysis for 

Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a 

determination needs to be made early in the PRA for importation as to whether the LMO 

poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment 

procedures for genetically engineered organisms are consistent with the guidance developed 

under the IPPC. In addition, issues that may relate to commercialization and transboundary 

movement of particular agricultural commodities produced through biotechnology are being 

addressed in other international forums and through national regulations. 

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on

Biological Diversity (CBD) that established a framework for the safe transboundary movement, 

with respect to the environment and biodiversity, of LMOs, which 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 U.S. is not a party to the CBD, 

and thus not a party to the Cartagena Protocol on Biosafety, U.S. exporters will still need to 

comply with those regulations that importing countries which are Parties to the Protocol have 

promulgated to comply with their obligations. The first intentional transboundary movement of 

LMOs intended for environmental release (field trials or commercial planting) will require consent 

from the importing country under an advanced informed agreement (AIA) provision, which 

includes a requirement for a risk assessment consistent with Annex III of the Protocol and the 

required documentation. 
82

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and 

are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post 

decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may 

be subject to transboundary movement. To facilitate compliance with obligations to this 

protocol, the U.S. Government has developed a website that provides the status of all 

regulatory reviews completed for different uses of bioengineered products (NBII, 2010). These 

data will be available to the Biosafety Clearinghouse. 

APHIS continues to work toward harmonization of biosafety and biotechnology consensus 

documents, guidelines, and regulations, including within the North American Plant Protection 

Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the 

Organization for Economic Cooperation and Development (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, 2009). 

APHIS also participates in the North American Biotechnology Initiative (NABI), a forum for 

information exchange and cooperation on agricultural biotechnology issues for the U.S., 

Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are 

held regularly with other countries including Argentina, Brazil, Japan, China, and Korea. 

7.3 Compliance with the Clean Water Act and Clean Air Act 

This EA evaluated the changes in corn production due to the unrestricted use of MON87460. 

Cultivation of MON87460 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 MON87460 

compared with current corn production. Also, there is no expected change in air quality 

associated with the cultivation of MON87460. 

Based on this review, APHIS concludes that the cultivation of MON87460 would comply with 

the Clean Water Act and the Clean Air Act. 

7.4 Impacts on Unique Characteristics of Geographic Areas 

There are no unique characteristics of geographic areas such as park lands, prime farm lands, 

wetlands, wild and scenic areas, or ecologically critical areas that would be adversely impacted 

by a determination of nonregulated status of MON87460. 

The common agricultural practices that would be carried out under the proposed action will not 

cause major ground disturbance; do not cause any physical destruction or damage to property; do 

not cause any alterations of property, wildlife habitat, or landscapes; and do not involve the sale, 

lease, or transfer of ownership of any property. This action is limited to a determination of 

nonregulated status of MON87460. The product will be deployed on agricultural land currently 

suitable for production of corn, will replace existing varieties, and is not expected to increase the 

acreage of corn production. Progeny of this variety that express the identified traits of the 

MON87460 will be retained by Monsanto or licensed users. This action would not convert land 
83

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 MON87460 including the use of EPA registered 

pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate 

potential impacts to the human environment. In the event of a determination of nonregulated 

status of MON87460, the action is not likely to affect historic or cultural resources, park lands, 

prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas that may be in 

close proximity to corn production sites. 

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. 

APHIS’ proposed action, a determination of nonregulated status of MON87460 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. 

A determination of nonregulated status of MON87460 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 significant scientific, cultural, or 

historical resources. This action is limited to a determination of nonregulated status of 

MON87460. Standard agricultural practices for land preparation, planting, irrigation, and 

harvesting of plants would be used on these agricultural lands including the use of EPA 

registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will 

mitigate impacts to the human environment. A determination of nonregulated status of 

MON87460 is not an undertaking that may directly or indirectly cause alteration in the character 

or use of historic properties protected under the National Historic Preservation Act. In general, 

common agricultural activities conducted under this action do not have the potential to introduce 

visual, atmospheric, or audible elements to areas in which they are used that could result in 

effects on the character or use of historic properties. For example, there is potential for audible 

effects on the use and enjoyment of a historic property when common agricultural practices, such 

as the operation of tractors and other mechanical equipment, are conducted close to such sites. A 

built-in mitigating factor for this issue is that virtually all of the methods involved would only 

have temporary effects on the audible nature of a site and can be ended at any time to restore the 

audible qualities of such sites to their original condition with no further adverse effects. 

Additionally, these cultivation practices are already being conducted throughout the corn 

production regions. The cultivation of MON87460 does not inherently change any of these 

agronomic practices so as to give rise to an impact under the NHPA. 
84

7.6 International Impacts Analysis 

7.6.1 Transboundary Impacts 

The CEQ guidance on NEPA analyses for transboundary impacts (CEQ 1997) requires Federal 

officials to consider reasonably foreseeable transboundary effects in the environmental analysis 

of proposed actions occurring in the U.S. Potential transboundary impacts on Mexico and 

Canada are addressed below. 

As discussed in the Animal and Plant Communities Affected Environment section, APHIS 

evaluated the potential for gene flow to occur from MON87460 to sexually compatible wild 

relatives. As stated previously, cultivated corn is sexually compatible with its closest relative, 

teosinte, and with members of the genus Tripsacum, although to a much lesser degree 

(Mangelsdorf, 1974; OECD, 2003; Wilkes, 1967). Corn and teosinte are genetically compatible, 

wind-pollinated, and can hybridize when close to each other, but hybridization would only be 

likely to occur in Mexico and Guatemala because teosinte is not present in the U.S., except for a 

few small feral populations of Zea mexicana in Alabama, Florida, Maryland (USDA-NRCS, 

2010), and Zea perennis in South Carolina (USDA-NRCS, 2011). Tripsacum species have one 

less chromosome than corn but can hybridize with corn, although it is very difficult and requires 

special techniques, and the hybrids have a high degree of sterility and are genetically unstable 

(Mangelsdorf, 1974). Crosses between corn and Tripsacum dactyloides can be made, but only 

through human intervention and, even then, it is extremely difficult (CFIA, 1994). 

MON87460 is not likely to hybridize with sexually compatible species in the United States 

because of differences in factors such as flowering time, geographical separation, and 

development factors (Galinat, 1988). Further, Tripsacum dactyloides and Tripsacum floridanum

would not be affected by MON87460 because of the difficulty of hybridizing with these species. 

The potential impact of gene flow into teosinte is not expected to be any different than that of 

other currently available cultivated corn varieties. Based on these considerations, and in 

particular geographic separation, APHIS anticipates no potential direct, indirect or cumulative 

transboundary gene flow impacts into teosinte found in Mexico. No known sexually compatible 

species were identified in Canada, and APHIS has identified no potential direct, indirect or 

cumulative transboundary gene flow impacts in relation to Canada following from a 

determination of nonregulated status of MON87460. 

 
85

8 REFERENCES 

Almaraz JJ, Mabood F, Zhou X, Madramootoo C, Rochette P, Ma B-L, and Smith DL. (2009) 

Carbon Dioxide and Nitrous Oxide Fluxes in Corn Grown under Two Tillage Systems in 

Southwestern Quebec. Soil Science Society of America, 73(1), 113-119. 

Aneja VP, Schlesinger WH, and Erisman JW. (2009) Effects of Agriculture upon the Air Quality 

and Climate: Research, Policy, and Regulations. Environmental Science & Technology, 

43(12), 4234-4240. 

Angers DA, Bolinder MA, Carter MR, Gregorich EG, Drury CF, Liang BC, Voroney RP, 

Simard RR, Donald RG, Beyaert RP, and Martel J. (1997) Impact of tillage practices on 

organic carbon and nitrogen storage in cool, humid soils of eastern Canada. Soil and 

Tillage Research, 41(3-4), 191-201. 

AOSCA (2003) AOSCA: 99% Non-GMO Corn Grain Program Requirements. American 

Association of Seed Certifying Agenicies. Retrieved March 2011, from 

http://www.identitypreserved.com/handbook/aosca-nongmocorn.htm

AOSCA. (2009) Seed Certification Handbook: Including Genetic and Crop Standards, 

Procedures, and AOSCA Service Programs. 

Asgrow and DeKalb (2011). 2011 Seed Resource Guide. Submitted by Registration Manager. 

(See Table 

https://www.asgrowanddekalb.com/products/Documents/2011_seed_resource_guide_nor

th.pdf). 

Badosa E, Moreno C, and Montesinos E. (2004) Lack of detection of ampicillin resistance gene 

transfer from Bt176 transgenic corn to culturable bacteria under field conditions. FEMS 

Microbiology Ecology, 48(2), 169-178. 

Bais HP, Weir TL, Perry LG, Gilroy S, and Vivanco JM. (2006) The role of root exudates in 

rhizosphere interactions with plants and other organisms. Annual Review of Plant 

Biology, 57(1), 233-266. 

Baker HG. (1965) Characteristics and modes of origin of weeds. In HG Baker and GL Stebbins 

(Eds.), The Genetics of Colonizing Species (pp. 147-168). Berkeley, CA: Department of 

Botany, University of California, Berkeley, USA. 

Baker JB, Southard RJ, and Mitchell JP. (2005) Agricultural Dust Production in Standard and 

Conservation Tillage Systems in the San Joaquin Valley. Journal of Environmental 

Quality, 34(4), 1260-1269. 

Baker JM, Ochsner TE, Venterea RT, and Griffis TJ. (2007) Tillage and soil carbon 

sequestration—What do we really know? Agriculture, Ecosystems & Environment, 

118(1-4), 1-5. 

Ball BC, Crichton I, and Horgan GW. (2008) Dynamics of upward and downward N2O and 

CO2 fluxes in ploughed or no-tilled soils in relation to water-filled pore space, 

compaction and crop presence. Soil and Tillage Research, 101(1-2), 20-30. 

Barker T, Campos H, Cooper M, Dolan D, Edmeades G, Habben J, Schussler J, Wright D, and 

Zinselmeier C. (2005) Improving drought tolerance in maize. In J Janick (Ed.), Plant 

Breeding Reviews): John Wiley and Sons, Inc 

Barr KJ, Babcock BA, Carriquiry M, Nasser A, and Harfuch L (2010) Agricultural Land 

Elasticities in the United States and Brazil. Center for Agricultural and Rural 

Development, Iowa State University. Retrieved from 

http://ageconsearch.umn.edu/bitstream/58047/2/10-WP_505.pdf
86

Beasley JC and Rhodes Jr. OE. (2008) Relationship between raccoon abundance and crop 

damage. Human-Wildlife Conflicts, 2(2), 248-259. 

Benbrook C (2009) Crops on Pesticide Use in the United States: The First Thirteen Years. The 

Organic Center. Retrieved from http://www.organiccenter.org/reportfiles/GE13YearsReport.pdf

Bengtsson J, Ahnström J, and Weibull A. (2005) The effects of organic agriculture on 

biodiversity and abundance: a meta-analysis. Journal of Applied Ecology, 42(2), 261-269. 

Best LB and Gionfriddo JP. (1991) Characterization of Grit Use by Cornfield Birds. The Wilson 

Bulletin by the Wilson Ornithological Society, 103(1), 68-82. 

Bosnic AC and Swanton CJ. (1997) Influence of barnyardgrass (Echinochloa crusgalli) time of 

emergence and density on corn (Zea mays). Weed Science, 45(2), 276-282. 

Boyer JS. (1982) Plant productivity and environment. Science, 218(4571), 443. 

Brookes G and Barfoot P (2010) GM crops: global socio-economic and environmental impacts 

1996-2008. PG Economics Ltd, Dorchester, UK. Retrieved from 

http://www.pgeconomics.co.uk/

Brooks DR, Bohan DA, Champion GT, Haughton AJ, Hawes C, Heard MS, Clark SJ, Dewar 

AM, Firbank LG, Perry JN, Rothery P, Scott RJ, Woiwod IP, Birchall C, Skellern MP, 

Walker JH, Baker P, Bell D, Browne EL, Dewar AJG, Fairfax CM, Garner BH, Haylock 

LA, Horne SL, Hulmes SE, Mason NS, Norton LR, Nuttall P, Randle Z, Rossall MJ, 

Sands RJN, Singer EJ, and Walker MJ. (2003) Invertebrate responses to the management 

of genetically modified herbicide–tolerant and conventional spring crops. I. Soil-surfaceactive invertebrates. Philosophical Transactions of the Royal Society of London. Series B: 

Biological Sciences, 358(1439), 1847-1862. 

Bruce WB, Edmeades GO, and Barker TC. (2002) Molecular and physiological approaches to 

maize improvement for drought tolerance. Journal of Experimental Botany, 53(366), 13-

25. 

Burzio LA, McClain JS, and Silvanovich A. (2008). Bioinformatics evaluation of the CSPB 

protein utilizing the AD8, TOXIN6 and PROTEIN databases. Monsanto Company. 

Campbell S. (2003) Insuring best management practices. Journal of Soil and Water 

Conservation, 58(6), 116A-117A. 

CBD (2010) The Cartegena Protocol on Biosafety. Convention on Biological Diversity. 

Retrieved March 30, 2010 from http://www.cbd.int/biosafety/

CCSP (2008) The Effects of Climate Change on Agriculture, Land Resources, Water Resources, 

and Biodiversity in the United States (U.S. Climate Change Science Program Synthesis 

and Assessment Product 4.3). The U.S. Climate Change Science Program. Retrieved 

October, 2011 from http://www.climatescience.gov/Library/sap/sap4-3/finalreport/Synthesis_SAP_4.3.pdf

CCSP (2009) Global Climate Change Impacts in the United States. U.S. Global Change 

Research Program. 

Cerrato ME and Blackmer AM. (1990) Comparison of models for describing corn yield response 

to nitrogen fertilizer. Agronomy Journal, 82(1), 138-143. 

CFIA. (1994).The biology of Zea mays (L.) (Maize). Plant Biosafety Office, Last accessed 

August 23, 2010, from http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9411e.pdf

Chen M, Zhao J-Z, Collins HL, Earle ED, Cao J, and Shelton AM. (2008) A critical assessment 

of the effects of Bt transgenic plants on parasitoids. PLoS One, 3(5), e2284. 
87

Childs D (1996) Top Ten Weeds. Purdue Plant Pest and Diagnostic Laboratory, Purdue 

University. Retrieved March 2011, from 

http://www.ppdl.purdue.edu/ppdl/expert/Top_Ten_Weeds.html

Christensen LA. (2002) Soil, nutrient, and water management systems used in U. S. corn 

production. Agriculture Information Bulletin, 774. 

Claassen R and Tegene A. (1999) Agricultural Land Use Choice: A Discrete Choice Approach. 

Agricultural and Resource Economics Review, 28(1), 26-35. 

Cook E, Bartlein P, Diffenbaugh N, Seager R, Shuman B, Webb R, Williams J, and Woodhouse 

C (2008) Hydrological Variability and Change. The U.S. Climate Change Science 

Program. 

Crockett L. (1977) Wildly successful plants: a handbook of North American weeds. Macmillan. 

Dale VH. (1997) The Relationship Between Land-Use Change and Climate Change. Ecological 

applications, 7(3), 753-769. 

Day J, Hallahan C, Sandretto C, and Lindamood W. (1999) Pesticide use in U.S. corn 

production: Does conservation tillage make a difference. Journal of Soil and Water 

Conservation, 54(2), 477-484. 

de Vries J and Wackernagel W. (2005) Microbial horizontal gene transfer and the DNA release 

from transgenic crop plants. Plant and Soil, 266(1), 91-104. 

Del Grosso SJ, Halvorson AD, and Parton WJ. (2008) Testing DAYCENT Model Simulations 

of Corn Yields and Nitrous Oxide Emissions in Irrigated Tillage Systems in Colorado. 

Journal of Environmental Quality, 37(4), 1383-1389. 

Delisle JM and Savidge JA. (1997) Avian use and vegetation characteristics of Conservation 

Reserve Program fields. Journal of Wildlife Management, 61, 318-325. 

Demanèche S, Sanguin H, Poté J, Navarro E, Bernillon D, Mavingui P, Wildi W, Vogel TM, and 

Simonet P. (2008) Antibiotic-resistant soil bacteria in transgenic plant fields. Proceedings 

of the National Academy of Sciences, 105(10), 3957-3962. 

Dolbeer RA. (1990) Ornithology and integrated pest management: red-winged blackbirds 

Agleaius phoeniceus and corn. The International Journal of Avian Science, 132, 309-322. 

Eastham K and Sweet J (2002) Genetically modified organisms (GMOs): The significance of 

gene flow through pollen transfer. European Environment Agency. 

EFSA. (2004) Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified 

Plants. Scientific Opinion of the Panel on Genetically Modified Organisms (GMO) and 

the Panel of Biological Hazards (BIOHAZ). EFSA Journal(4), 1-18. 

Elbehri A. (2007) The changing face of the US grain system. Economic Research Report No. 

ERR-35, Economic Research Service, USDA. 

Elmi A, Madramootoo C, Hamel C, and Liu A. (2003) Denitrification and nitrous oxide to 

nitrous oxide plus dinitrogen ratios in the soil profile under three tillage systems. Biology 

and Fertility of Soils, 38(6), 340-348. 

EPA. (2005) Protecting Water Quality for Agricultural Runoff. (EPA 841-F-05-001). 

EPA (2009) Soil Preparation. Environmental Protection Agency. Retrieved March 2011, from 

http://www.epa.gov/agriculture/ag101/cropsoil.html

EPA (2010a) Basic Information - Air Emission Sources. Retrieved March 2011, from 

http://www.epa.gov/air/emissions/basic.htm

EPA. (2010b).Climate change indicators in the United States. Environmental Protection Agency, 

Washington DC. Last accessed from 

http://www.epa.gov/climatechange/indicators/pdfs/ClimateIndicators_full.pdf
88

EPA (2010c) Inventory of U.S. greenhouse gas emissions and sinks: 1990-2008. Retrieved 

March 2011, from http://www.epa.gov/climatechange/emissions/downloads10/US-GHGInventory-2010_Report.pdf

EPA (2010d) National Ambient Air Quality Standards (NAAQS). Retrieved March 2011, from 

http://www.epa.gov/air/criteria.html

FAOSTAT (2008) Food and agricultural commodities production. . Retrieved March 2011, 

from http://faostat.fao.org/site/339/default.aspx

FAPRI (2004) Documentation of the FAPRI Modeling System. Food and Agricultural Policy 

Research Institute. Retrieved from 

http://www.fapri.missouri.edu/outreach/publications/2004/FAPRI_UMC_Report_12_04.

pdf

Farahbakhshazad N, Dinnes DL, Li C, Jaynes DB, and Salas W. (2008) Modeling 

biogeochemical impacts of alternative management practices for a row-crop field in 

Iowa. Agriculture, Ecosystems & Environment, 123(1-3), 30-48. 

Fargione J, Hill J, Tilman D, Polasky S, and Hawthorne P. (2008) Land Clearing and the Biofuel 

Carbon Debt. Science, 319(5867), 1235-1238. 

Fausey JC, James JK, Swinton SM, and Renner KA. (1997) Giant Foxtail (Setaria faberi) 

interference in nonirrigated corn (Zea mays). Weed Science, 45(2), 256-260. 

Faust MJ. (2002) New feeds from genetically modified plants: the US approach to safety for 

animals and the food chain. Livestock Production Science, 74(3), 239-254. 

Fawcett R and Caruana S (2001) Better soil, better yields: A guidebook to improving soil organic 

matter and infiltration. CTIC. Retrieved from 

http://www.ctic.purdue.edu/media/pdf/Better%20Soil%20Better%20Yields.pdf

FDA (1998) Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic 

Plants. U.S. Food and Drug Administration. Retrieved September, 2011 from 

http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/

biotechnology/ucm096135.htm

Carbohydrase and protease enzyme preparations derived from Bacillus subtilis or Bacillus 

amyloliquefaciens; affirmation of GRAS status as direct food ingredients, FDA. 

FDA (2010) List of Completed Consultations on Bioengineered Foods. United States Food and 

Drug Administration, Center for Food Safety and Applied Nutrition, College Park, 

Maryland. United States Food and Drug Administration. Retrieved January 2011 from 

http://www.fda.gov/Food/Biotechnology/Submissions/default.htm

Fernandez-Cornejo J, Nehring R, Sinha EN, Grube A, and Vialou A. (2009) Assessing recent 

trends in pesticide use in U. S. agriculture. Paper presented at the Meeting of the AAEA, 

Milwaukee, WI. 

Flachowsky G, Chesson A, and Aulrich K. (2005) Animal nutrition with feeds from genetically 

modified plants. Archives of Animal Nutrition, 59(1), 1-40. 

Food Conservation and Energy Act. (2008). 

Fuchs R, Heeren R, Gustafson M, Rogan G, Bartnicki D, Leimgruber R, Finn R, Hershman A, 

and Berberich S. (1993a) Purification and Characterization of Microbially Expressed 

Neomycin Phosphotransferase II (NPTII) Protein and its Equivalence to the Plant 

Expressed Protein. Nature Biotechnology, 11(12), 1537-1542. 

Fuchs RL, Ream JE, Hammond BG, Naylor MW, Leimgruber RM, and Berberich SA. (1993b) 

Safety Assessment of the Neomycin Phosphotransferase II (NPTII) Protein. Nature 

Biotechnology, 11(12), 1543-1547. 
89

Galinat W. (1988) The origin of corn. In GF Sprague and JW Dudley (Eds.), Corn and Corn 

Improvement (pp. 1-27). Madison, WI: American Society of Agronomy, Inc., Crop Soil 

Science Society of America, Inc., and the Soil Science Society of America, Inc. 

GAO. (2001) Chemical risk assessment: Selected Federal agencies' procedures, assumptions, and 

policies. United States General Accounting Office Report to Congressional Requesters. 

August 2001. GAO-01-810 

Gebhard F and Smalla K. (1999) Monitoring field releases of genetically modified sugar beets 

for persistence of transgenic plant DNA and horizontal gene transfer. FEMS 

Microbiology Ecology, 28(3), 261-272. 

Giannessi LP. (2005) Economic and herbicide use impacts of glyphosate-resistant crops. Pest 

Management Science, 61, 241-245. 

Giles D, Downey D, and Thompson J (2006) In Field Assessments of Dust Generation of 

Harvesting Equipment. Workshop on Agricultural Air Quality. Retrieved from 

http://www.ncsu.edu/airworkshop/Emissions_Crop.pdf

Gould F. (1968) Grass Systematics. New York, New York: McGraw Hill, NJ. 

Grandy AS, Loecke TD, Parr S, and Robertson GP. (2006) Long-Term Trends in Nitrous Oxide 

Emissions, Soil Nitrogen, and Crop Yields of Till and No-Till Cropping Systems. 

Journal of Enviromental Quality, 35(4), 1487-1495. 

Greene C, Dimitri C, Lin B-H, McBride W, Oberholter L, and Smith T (2009) Emerging issues 

in the U.S. organic industry. USDA-ORS. Retrieved October 2011, from 

http://www.ers.usda.gov/publications/eib55/eib55.pdf

Gregorich EG, Rochette P, Hopkins DW, McKim UF, and St-Georges P. (2006) Tillage-induced 

environmental conditions in soil and substrate limitation determine biogenic gas 

production. Soil Biology and Biochemistry, 38(9), 2614-2628. 

Gregorich EG, Rochette P, VandenBygaart AJ, and Angers DA. (2005) Greenhouse gas 

contributions of agricultural soils and potential mitigation practices in Eastern Canada. 

Soil and Tillage Research, 83(1), 53-72. 

Greuere GP (2006) An analysis of trade related international regulations of genetically modified 

food and their effects on developing countries. International Food Policy Research 

Institute. Retrieved from http://www.ifpri.org/publication/analysis-trade-relatedinternational-regulations-genetically-modified-food-and-their-eff

Griffiths BS, Caul S, Thompson J, Birch ANE, Cortet J, Andersen MN, and Krogh PH. (2007a) 

Microbial and microfaunal community structure in cropping systems with genetically 

modified plants. Pedobiologia, 51(3), 195-206. 

Griffiths BS, Heckmann LH, Caul S, Thompson J, Scrimgeour C, and Krogh PH. (2007b) 

Varietal effects of eight paired lines of transgenic Bt maize and near-isogenic non-Bt 

maize on soil microbial and nematode community structure. Plant Biotechnology 

Journal, 5(1), 60-68. 

Gutowski W, Hergerl G, Holland G, Knutson T, Mearns L, Stouffer R, Webster P, Wehner M, 

Zwiers F, Brooks H, Emanuel K, Komar P, Kossin J, Kunkel K, McDonald R, Meehl G, 

and Trapp R (2008) Causes of Observed Changes in Extremes and Projections of Future 

Changes. The U.S. Climate Change Science Program. Retrieved October, 2011 from 

http://www.climatescience.gov/Library/sap/sap3-3/final-report/sap3-3-final-Chapter3.pdf

Hall M, Swanton C, and Anderson G. (1992) The Critical Period of Weed Control in Grain Corn 

(Zea mays). Weed Science, 40(3), 441-447. 
90

Hall RC and Twidwell EK (2002) Effects of drought stress on corn production. Cooperative 

Extension Service. Retrieved from http://www.sdstate.edu/sdces/store/Publications/pubdetails.cfm?customel_datapageid_858688=872114

Halvorson AD, Del Grosso SJ, and Reule CA. (2008) Nitrogen, Tillage, and Crop Rotation 

Effects on Nitrous Oxide Emissions from Irrigated Cropping Systems. Journal of 

Enviromental Quality, 37(4), 1337-1344. 

Hart CE. (2006) Feeding the Ethanol Boom: Where will the Corn come from? Iowa Agricultural 

Review, 12, 3-5. 

Hawes C, Haughton AJ, Osborne JL, Roy DB, Clark SJ, Perry JN, Rothery P, Bohan DA, 

Brooks DR, Champion GT, Dewar AM, Heard MS, Woiwod IP, Daniels RE, Young 

MW, Parish AM, Scott RJ, Firbank LG, and Squire GR. (2003) Responses of plants and 

invertebrate trophic groups to contrasting herbicide regimes in the Farm Scale 

Evaluations of genetically modified herbicide–tolerant crops. Philosophical Transactions 

of the Royal Society of London. Series B: Biological Sciences, 358(1439), 1899-1913. 

Heap IM (2008) International Survey of Herbicide Resistant Weeds. . Retrieved 1, from 

www.weedscience.com. 

Heisel E (1998) Biodiversity and Federal Land Ownership: Mapping a Strategy for the Future. 

Ecology Law Quarterly. 

Henry C, Morgan D, Weekes R, Daniels R, and Boffey C (2003) Farm scale evaluations of GM 

crops: monitoring gene flow from GM crops to non-GM equivalent crops in the vicinity 

(contract reference EPG 1/5/138). Part I: Forage Maize. DEFRA. Retrieved from 

http://www.cib.org.br/estudos/estudos_cientificos_alimentar_14.pdf

Utilizing Drought-Damaged Corn, 1-4 (1990). 

Hoeft R, Nafziger E, Johnson R, and Aldrich S. (2000) Modern corn and soybean production.

Savoy, IL: MCSP Publications. 

Holm L, Pancho J, Herberger V, and Plucknett DL. (1979) A geographical atlas of world weeds. 

471-04393. 

Holmén B, Miller D, Hiscox A, Yang W, Wang J, Sammis T, and Bottoms R. (2006) Aerosol 

Emissions from Field Planting Operations 

Howell TA, Tolk JA, Schneider AD, and Evett SR. (1998) Evapotranspiration, yield, and water 

use efficiency of corn hybrids differing in maturity. Agronomy Journal, 90(1), 3-9. 

Humberg L, DeVault T, MacGowan B, Beasley J, and Rhodes Jr O. (2007) Crop depredation by 

wildlife in northcentral Indiana 

IPPC (2007). Climate Change 2007: The Physical Science. Submitted by S Solomon, D. Qin, M. 

Manning, Registration Manager. Cambridge University Press (See Table 

IPPC (2010) Official web site for the International Plant Protection Convention: International 

Phytosanitary Portal International Plant Protection Convention. Retrieved March 30, 

2010 from https://www.ippc.int/IPP/En/default.jsp

Ireland D, Wilson Jr D, Westgate M, Burris J, and Lauer M. (2006) Managing reproductive 

isolation in hybrid seed corn production. Crop Science, 46(4), 1445. 

Johnson DH. (2000) Grassland bird use of Conservation Reserve Program Fields in the Great 

Plains. In WL Hohman and DJ Halloum (Eds.), A Comprehensive Review of Farm Bill 

Contributions to Wildlife Conservation, 1985-2000 (pp. 19-34). 

Johnson DH. (2005) Grassland bird use of Conservation Reserve Program fields in the Great 

Plains: 2000-2005 Update. In JB Haufler (Ed.), Fish and Wildlife Benefits of Farm Bill 

Programs: 2000-2005 Update). Bethesda, MD: Wildlife Society. 
91

Karl T, Meehl G, Miller C, Hassol S, Waple A, and Murray W (2008) Weather and Climate 

Extremes in a Changing Climate - Regions of Focus: North America, Hawaii, Caribbean, 

and U.S. Pacific Islands. The U.S. Climate Change Science Program. Retrieved October, 

2011 from http://www.climatescience.gov/Library/sap/sap3-3/final-report/

Keeler KH. (1989) Can genetically engineered crops become weeds? Biotechnology, 7(11), 

1134-1139. 

Kegley SE, Hill BR, Orme S, and Choi AH (2010) PAN Pesticide Database. Pesticide Action 

Network: North America. Retrieved March 2011, from http://www.pesticideinfo.org/

Kermicle JL and Evans MMS. (2010) The Zea mays sexual compatibility gene ga2: naturally 

occurring alleles, their distribution, and role in reproductive isolation. Journal of 

Heredity, 101, 737-749. 

Koele B (2008) Wildlife Damage Abatement and Claims Program, 2008. USDA. Retrieved 

from http://dnr.wi.gov/org/land/wildlife/damage/progreport.pdf

König A, Cockburn A, Crevel RWR, Debruyne E, Grafstroem R, Hammerling U, Kimber I, 

Knudsen I, Kuiper HA, Peijnenburg AACM, Penninks AH, Poulsen M, Schauzu M, and 

Wal JM. (2004) Assessment of the safety of foods derived from genetically modified 

(GM) crops. Food and Chemical Toxicology, 42(7), 1047-1088. 

Krueger JE (2007) If your farm is organic, must it be GMO-free? . Farmers' Legal Action Group, 

Inc. Retrieved from 

http://www.flaginc.org/topics/pubs/arts/OrganicsAndGMOs2007.pdf

Krupa S, Booker F, Bowersox V, and Grantz D. (2006) Uncertainties in the Current Knowledge 

of Atmospheric Trace Gases Associated with Cropping Systems in the US 

Kuepper G (2002) Organic field corn production. National Sustainable Agricultural Information 

Service. ATTRA. Retrieved from http://attra.ncat.org/attra-pub/PDF/fieldcorn.pdf

Kuepper G, Born H, and Gegner L (2007) Organic System Plan (OSP) Templates for Certifiers 

ATTRA. Retrieved from http://attra.ncat.org/attra-pub/PDF/OSPtemplates.pdf

KyCGA (2011) Feed Corn and distiller's grains promotion. Kentucky Corn Growers Association. 

Retrieved March 2011, from 

Lal R and Bruce J. (1999) The potential of world cropland soils to sequester C and mitigate the 

greenhouse effect. Environmental Science & Policy, 2(2), 177-185. 

Levine E. (1991) Management of Diabroticite Rootworms in Corn. Annual Review of 

Entomology, 36, 229-255. 

Lew A (2004) GEOGRAPHY: USA Retrieved Aug. 18, 2010, from 

http://www.geog.nau.edu/courses/alew/ggr346/text/chapters/ch8.html

Linn DM and Doran JW. (1984) Effect of Water-Filled Pore Space on Carbon Dioxide and 

Nitrous Oxide Production in Tilled and Nontilled Soils1. Soil Science Society of America, 

48(6), 1267-1272. 

MacKenzie A, Fan M, and Cadrin F. (1998) Nitrous Oxide Emission in Three years as Affected 

by Tillage, Corn-Soybean-Alfalfa Rotations, and Nitrogen Fertilization. Journal of 

environmental quality, 27(3), 698-703. 

Mallory-Smith C and Zapiola M. (2008) Gene flow from glyphosate-resistant crops. Pest 

management science, 64(4), 428-440. 

Mangelsdorf PC. (1974) Corn: Its origin, evolution, and improvement. Harvard University Press 

Cambridge, MA. 
92

Marvier M, McCreedy C, Regetz J, and Kareiva P. (2007) A meta-analysis of effects of Bt cotton 

and maize on nontarget invertebrates. Science, 316(5830), 1475-1477. 

McBride W (2005) Farm Income Less Important to Most Corn Farm Households. United States 

Department of Agriculture-Economic Research Service. Retrieved from 

http://www.ers.usda.gov/AmberWaves/February05/Findings/FarmIncomeLess.htm

McBride W. (2008) The Profitability of Organic Soybean Production. Paper presented at the 

American Agriculture Economics Association Annual Meeting, Orlando, FL. 

McWilliams D (2002) Drought Strategies for Corn and Grain Sorghum. Retrieved March 2011, 

from http://cahedev.nmsu.edu/pubs/_circulars/CR-580.pdf

Messmer R, Fracheboud Y, Bänziger M, Vargas M, Stamp P, and Ribaut J-M. (2009) Drought 

stress and tropical maize: QTL-by-environment interactions and stability of QTLs across 

environments for yield components and secondary traits. TAG Theoretical and Applied 

Genetics, 119(5), 913-930. 

Metay A, Oliver R, Scopel E, Douzet J-M, Aloisio Alves Moreira J, Maraux F, Feigl BJ, and 

Feller C. (2007) N2O and CH4 emissions from soils under conventional and no-till 

management practices in Goiânia (Cerrados, Brazil). Geoderma, 141(1-2), 78-88. 

Monsanto (2010) Petition for the Determination of Nonregulated Status for MON 87460. 

Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See 

Table http://www.aphis.usda.gov/biotechnology/not_reg.html). 

Morris M and Hill A (1998) Overview of the world maize economy. Retrieved from 

Muenscher W. (1980) Weeds, Reprinted. Cornell University Press, Ithaca, New York. 

Nap J-P, Bijvoet J, and Stiekema W. (1992) Biosafety of kanamycin-resistant transgenic plants. 

Transgenic Research, 1(6), 239-249. 

NAPPO (2009) NAPPO approved standards. North American Plant Protection Organization. 

Retrieved April 22, 2010 from http://www.nappo.org/Standards/Std-e.html

NBII (2010) United States Regulatory Agencies Unified Biotechnology Website. United States 

National Biological Information Infrastructure, Center for Biological Informatics 

Geological Survey. Retrieved March 30, 2010 from http://usbiotechreg.nbii.gov/

NCAT (2003) NCAT's organic crops workbook: a guide to sustainable and allowed practices. 

Retrieved from http://attra.ncat.org/attra-pub/PDF/cropsworkbook.pdf

NCGA (2007) Truths about water use, corn, and ethanol. Retrieved Febraury 2011, from 

Neild RE and Newman JE. (1990) Growing Season Characteristics and Requirements in the 

Corn Belt. In RF Dale, DG Hanway, RE Carlson, GO Benson, RE Felch, CM Sakamoto, 

EA Runge, RM Castleberry, MW Seeley, RH Shaw, DR Hicks and RL Nielsen (Eds.), 

National Corn Belt). 

Neilsen B (1995) Symptoms of deer corn damage. Purdue Plant and Pest Diagnostic Laboratory. 

Purdue University. Retrieved March 2011, from 

http://www.ppdl.purdue.edu/PPDL/weeklypics/1-10-05.html

NOAA (2010) Total Precipitation in Inches by Month. Climatology by State based on Climate 

Division Data: 1971-2000. Retrieved March 2011, from 

http://www.esrl.noaa.gov/psd/data/usclimate/pcp.state.19712000.climo

Non-GMO-Project (2010) Non-GMO Project. Retrieved July 31, 2010, from 

http://www.nongmoproject.org/

NRC. (2004) Safety of Genetically Engineered Foods: Approaches to Assessing Unintended 

Health Effects. The National Academies Press:Washington, D.C. 
93

NRC. (2010) Impact of Genetically Engineered Crops on Farm Sustainability in the United 

States. The National Academies Press:Washington, DC. 

NRCS (2011) National Resources Inventory. Unisted States Department of Agriculture Natural 

Resources Conservation Service. Retrieved March 2011, from 

http://www.nrcs.usda.gov/technical/NRI/

OECD (2003) Consensus document on the biology of Zea mays subsp. mays (maize). 

Organization for Economic Co-operation and Development Retrieved from 

http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=ENV/JM/MONO(20

03)11&doclanguage=en

Olson RA and Sander DH. (1988) Corn Production. In GF Sprague and JW Dudley (Eds.), Corn 

and Corn Improvement (pp. 639-686): American Society of Agronomy-Crop Science 

Society of America-Soil Science Society of America. 

Oorts K, Merckx R, Gréhan E, Labreuche J, and Nicolardot B. (2007) Determinants of annual 

fluxes of CO2 and N2O in long-term no-tillage and conventional tillage systems in 

northern France. Soil and Tillage Research, 95(1-2), 133-148. 

OTA (2010) Industry Statistics and Projected Growth. Organic Trade Association. Retrieved 

February 2011, from http://www.ota.com/organic/mt/business.html

Paget E, Lebrun M, Freyssinet G, and Simonet P. (1998) The fate of recombinant plant DNA in 

soil. European Journal of Soil Biology, 34(2), 81-88. 

Palma RM, Rímolo M, Saubidet MI, and Conti ME. (1997) Influence of tillage system on 

denitrification in maize-cropped soils. Biology and Fertility of Soils, 25(2), 142-146. 

Patterson MP and Best LB. (1996) Bird abundance and nesting success in Iowa CRP fields: The 

importance of vegetation structure and composition. American Midland Naturalist, 

135(1), 153-167. 

Paulson N and Babcock B. (2010) Readdressing the Fertilizer Problem. Journal of Agricultural 

and Resource Economics, 35(3), 368-384. 

Philippe R. (2008) No-till only increases N2O emissions in poorly-aerated soils. Soil and Tillage 

Research, 101(1-2), 97-100. 

Piñeiro G, Jobbágy EG, Baker J, Murray BC, and Jackson RB. (2009) Set-asides can be better 

climate investment than corn ethanol. Ecological applications, 19(2), 277-282. 

Pioneer (2009) Petition for the Determination of Nonregulated Satus for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted 

by Natalie Weber, Regulatory Affairs Manager. Pioneer Hi-Bred International, Inc. (See 

Table 

Pioneer (2010) Pioneer Research to Develop Drought Tolerant Corn Hybrids. Retrieved from 

http://www.pioneer.com/CMRoot/pioneer/us/agronomy/agronomy_research_summary/2

010/low_water_environments/2010_drought_tolerant_corn_hybrids.pdf

Pioneer (2011a) Introducing Optimum Aquamax Hybrids. Retrieved 3-9-11, from 

http://www.pioneer.com/CMRoot/pioneer/us/products/seed_trait_technology/optimum_a

quamax/aquamax_product_info_brochure.pdf

Pioneer (2011b) Optimum AQUAmax hybrids. Retrieved from 

http://www.pioneer.com/home/site/us/products/corn/seed-traits-technologiescorn/optimum-aquamax-hybrids/

Plantinga AJ, Alig R, and Cheng Ht. (2001) The supply of land for conservation uses: evidence 

from the conservation reserve program. Resources, Conservation and Recycling, 31(3), 

199-215. 
94

Poirier V, Angers DA, Rochette P, Chantigny MH, Ziadi N, Tremblay G, and Fortin J. (2009) 

Interactive Effects of Tillage and Mineral Fertilization on Soil Carbon Profiles. Soil 

Science Society of America, 73(1), 255-261. 

Ponsard S, Gutierrez AP, and Mills NJ. (2002) Effect of Bt-toxin (Cry1Ac) in transgenic cotton 

on the adult longevity of four Heteropteran predators. Environmental Entomology, 31, 

1197-1205. 

Potter KN, Torbert HA, Jones OR, Matocha JE, Morrison Jr JE, and Unger PW. (1998) 

Distribution and amount of soil organic C in long-term management systems in Texas. 

Soil and Tillage Research, 47(3-4), 309-321. 

Rieger MA, Lamond M, Preston C, Powles SB, and Roush RT. (2002) Pollen-Mediated 

Movement of Herbicide Resistance Between Commercial Canola Fields. Science, 

296(5577), 2386-2388. 

Rochette P, Angers DA, Chantigny MH, and Bertrand N. (2008) Nitrous Oxide Emissions 

Respond Differently to No-Till in a Loam and a Heavy Clay Soil. Soil Science Society of 

America, 72(5), 1363-1369. 

Romeis J, Meissle M, and Bigler F. (2006) Transgenic crops expressing Bacillus thuringiensis

toxins and biological control. Nature Biotechnology, 24(1), 63-71. 

Rosenzweig C, Iglesias A, Yang XB, Epstein PR, and Chivian E. (2001) Climate change and 

extreme weather events: Implications for food production, plant diseases, and pests. 

Global Change and Human Health, 2(2), 90-104. 

Rosenzweig C and Parry ML. (1994) Potential impact of climate change on world food supply. 

Nature, 367(6459), 133-138. 

Roy DB, Bohan DA, Haughton AJ, Hill MO, Osborne JL, Clark SJ, Perry JN, Rothery P, Scott 

RJ, Brooks DR, Champion GT, Hawes C, Heard MS, and Firbank LG. Invertebrates and 

vegetation of field margins adjacent to crops subject to contrasting herbicide regimes in 

the Farm Scale Evaluations of genetically modified herbicide-tolerant crops. 

Philosophical Transactions of the Royal Society of London. Series B: Biological 

Sciences, 358(1439), 1879-1898. 

Ruser R, Flessa H, Russow R, Schmidt G, Buegger F, and Munch JC. (2006) Emission of N2O, 

N2 and CO2 from soil fertilized with nitrate: effect of compaction, soil moisture and 

rewetting. Soil Biology and Biochemistry, 38(2), 263-274. 

Russell WA and Hallauer AR. (1980) Corn. In WR Fehr and HH Hadley (Eds.), Hybridization of 

crop plants (pp. 302). Madison, WI: American Society of Agronomy and Crop Science 

Society of America. 

Ruth L. (2003) Tailoring thresholds for GMO testing. Analytical chemistry, 75(17), 392-396. 

Sanvido O, Widmer F, Winzeler M, Streit B, Szerencsits E, and Bigler F. (2008) Definition and 

feasibility of isolation distances for transgenic maize cultivation. Transgenic research, 

17(3), 317-335. 

Schmidhuber J and Tubiello FN. (2007) Global food security under climate change. Proceedings 

of the National Academy of Sciences, 104(50), 19703-19708. 

Secchi S, Gassman P, Williams J, and Babcock B. (2009) Corn-Based Ethanol Production and 

Environmental Quality: A Case of Iowa and the Conservation Reserve Program. 

Environmental Management, 44(4), 732-744. 

Sheriff G. (2006) Efficient waste - Why farmers over-apply nutrients and the implications for 

policy design Review of Agricultural Economics, 27(4), 542-557. 
95

Six J, Ogle SM, Jay breidt F, Conant RT, Mosier AR, and Paustian K. (2004) The potential to 

mitigate global warming with no-tillage management is only realized when practised in 

the long term. Global Change Biology, 10(2), 155-160. 

Smedley JW (2008) An acute toxicity study of cold shock protein B administered by the oral 

(gavage) route to mice. 

Smika D and Wicks G. (1968) Soil water storage during fallow in the Central Great Plains as 

influenced by tillage and herbicide treatments. Soil Science Society of America Journal, 

32(4), 591. 

Smith D and White D. (1988) Diseases of Corn. In GF Sprague and JW Dudley (Eds.), Corn and 

Corn Improvement (pp. 687-749). Madison, WI: American Society of Agronomy. 

Smith J (2005) Small Mammals and Agriculture - A study of Effects and Responses. St. Olaf 

College. Retrieved March 2011, from http://www.stolaf.edu/depts/environmentalstudies/courses/es-399%20home/es-399-

05/Projects/Jared's%20Senior%20Seminar%20Research%20Page/index.htm

Smith KA and Conen F. (2004) Impacts of land management on fluxes of trace greenhouse 

gases. Soil Use and Management, 20(2), 255-263. 

Smith W, Desjardins R, Grant B, and Lemke R. (2002) Estimated N20 Emissions as Influenced 

by Agricultural Practices in Canada. Paper presented at the 12th ISCO Conference, 

Beijing. 

Southwood TRE and Way MJ. (1970) Ecological background to pest management Concepts of 

Pest Management (pp. 7-28). Raleigh: N.C. State University. 

Stallman HR and Best LB. (1996) Small-mammal use of an experimental strip intercropping 

system in northeastern Iowa. American Midland Naturalist, 135(2), 266-273. 

Steinbach HS and Alvarez R. (2006) Changes in Soil Organic Carbon Contents and Nitrous 

Oxide Emissions after Introduction of No-Till in Pampean Agroecosystems. Journal of 

Enviromental Quality, 35(1), 3-13. 

Sterner RT, Petersen BE, Gaddis SE, Tope KL, and Poss DJ. (2003) Impacts of small mammals 

and birds on low-tillage, dryland crops. Crop Protection, 22(4), 595-602. 

Stockton M, Wilson R, and Colburn F (2007) Continuous Corn or a Corn/Soybean Rotation? 

University of Nebraska - Lincoln Extension, Institute of Agricultureand Natural 

Resources. Retrieved from 

Sundstrom F, Williams J, Van Deynze A, and Bradford K. (2002) Identity preservation of 

agricultural commodities. ANR Publications. 

Tan IYS, van Es HM, Duxbury JM, Melkonian JJ, Schindelbeck RR, Geohring LD, Hively WD, 

and Moebius BN. (2009) Single-event nitrous oxide losses under maize production as 

affected by soil type, tillage, rotation, and fertilization. Soil and Tillage Research, 102(1), 

19-26. 

Thomison P (2011) Managing "Pollen" Drift to Minimize Contamination of Non-GMO Corn, 

AGF-153. Retrieved October, 2011 from http://ohioline.osu.edu/agf-fact/0153.html

Torres JB and Ruberson JR. (2005) Canopy- and Ground-Dwelling Predatory Arthropods in 

Commercial Bt and non-Bt Cotton Fields: Patterns and Mechanisms. Environmental 

entomology, 34(5), 1242-1256. 

Tu H. (2009) Updated bioinforamtic evaluation of the NPTII protein utilising the AD 2009 and 

TOX 2009 databases. 
96

US-NARA (2010) Executive Orders disposition tables index. United States National Archives 

and Records Administration. Retrieved March 11, 2010 from 

http://www.archives.gov/federal-register/executive-orders/disposition.html

USCB (2011) Per Capita Consumption of Major Food Commodities, 1980 - 2008. U.S. Census 

Bureau. Retrieved March 2011, from http://www.census.gov/compendia/statab/

USDA-AMS (2011) Policy Memorandum. Washington DC: United States Department of 

Agriculture, Agricultural Marketing Services, National Organics Program. 

USDA-APHIS (2010) Plant Pest Risk Assessment for MON 87460 Corn. Riverdale, MD: 

APHIS - Animal and Plant Health Inspection Service. Retrieved from 

http://www.aphis.usda.gov/biotechnology/not_reg.html

USDA-APHIS (2011) Petitions for Nonregulated Status Granted or Pending by APHIS. United 

States Department of Agriculture - Animal and Plant Health Inspection Service. 

Retrieved September, 2011 from http://www.aphis.usda.gov/biotechnology/not_reg.html

USDA-BRS (2006) Decision Tree on Whether Section 7 Consultation with FWS is Triggered for 

Petitions of Transgenic Plants. October 20, 2005. Revised July 11, 2006. Retrieved 

from http://www.aphis.usda.gov/brs/aphisdocs/04_30901r_ea.pdf

USDA-ERS (2010a) Adoption of Genetically Engineered Crops in the U.S.: Corn Varieties. 

Retrieved Aug. 11 2010, from 

http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable1.htm

USDA-ERS. (2010b) Agricultural Projections to 2019. 

USDA-ERS (2010c) NEW Feed Grains Data: Yearbook Tables, Corn: Food, seed, and industrial 

use. Retrieved March 2011, from 

http://www.ers.usda.gov/data/FeedGrains/Table.asp?t=31

USDA-ERS (2010d) Organic Production. Retrieved February 2011, from 

http://www.ers.usda.gov/Data/Organic/

USDA-ERS (2010e) USDA Feed Grain Baseline, 2010-19. Retrieved January 2011, from 

http://www.ers.usda.gov/briefing/corn/2010baseline.htm

USDA-ERS (2011a) The Ethanol Decade: An Expansion of U.S. Corn Production, 2000-09. 

EIB-79. United States Department of Agriculture, Economic Research Service. 

Retrieved September, 2011 from http://www.ers.usda.gov/Publications/EIB79/EIB79.pdf

USDA-ERS (2011b) Organic agriculture: Organic trade. United States Department of 

Agriculture-Economic Research Service. Retrieved March 2011, from 

http://www.ers.usda.gov/briefing/organic/trade.htm

USDA-ERS (2011c) USDA Agricultural Projections to 2020. United States Department of 

Agriculture - Economic Research Service. Retrieved March, 2011 from 

http://www.ers.usda.gov/Publications/OCE111/OCE111.pdf

USDA-FAS (2006) Egypt. Biotechnology. Annual Agricultural Biotechnology Report 2006. 

Retrieved Aug. 22, 2010, from http://www.fas.usda.gov/gainfiles/200607/146208389.pdf

USDA-FAS (2008a) Mexico Biotechnology. GAIN Report. Retrieved Aug. 22, 2010 from 

http://www.fas.usda.gov/gainfiles/200807/146295179.pdf

USDA-FAS (2008b) Republic of Korea Agricultural Biotechnology Report 2008. Retrieved 

Aug. 22, 2010, from http://www.fas.usda.gov/gainfiles/200807/146295192.pdf

USDA-FAS (2008c) Taiwan Biotechnology, Annual 2008. GAIN Report. Retrieved Aug. 22, 

2010 from http://www.fas.usda.gov/gainfiles/200810/146306245.pdf

USDA-FAS (2010a) Global Agricultural Trade System Online. Retrieved Aug. 21, 2010, from 

http://www.fas.usda.gov/gats/default.aspx
97

USDA-FAS (2010b) Grain: World Markets and Trade. Retrieved Aug. 21, 2010, from 

http://www.fas.usda.gov/grain/circular/2010/08-10/grainfull08-10.pdf

USDA-FAS (2011) U.S. organic exports continue to expand. United Stated Department of 

Agriculture-Foreign Agricultural Service. Retrieved March 2011, from 

http://www.fas.usda.gov/htp/organics/1-6-11%20Organics%20Summary.pdf

USDA-FSA (2009) Conservation Reserve Program: Summary and Enrollment Statistics. 

USDA-NASS. (2006).Agricultural Chemical Usage 2005 Field Crops Summary. United States 

Department of Agriculture - National Agricultural Statistics Service, Last accessed from 

http://usda.mannlib.cornell.edu/usda/nass/AgriChemUsFC//2000s/2006/AgriChemUsFC05-17-2006.pdf

USDA-NASS (2007) Irrigated Corn for Grain, Harvested Acres: 2007. . Retrieved Aug. 16, 

2010, from 

http://www.nass.usda.gov/research/2007mapgallery/album/Crops_and_Plants/Field_Crop

s_Harvested/slides/Irrigated%20Corn%20for%20Grain,%20Harvested%20Acres.html

USDA-NASS (2010a) Crop Production 2009 Summary. Retrieved Aug. 16, 2010, from 

USDA-NASS (2010b) National Statistics for Corn. Retrieved February 2011, from 

http://www.nass.usda.gov/Statistics_by_Subject/result.php?DAC4CC74-2AC5-3CB0-

B975-89BE9E64EAF8§or=CROPS&group=FIELD%20CROPS&comm=CORN

USDA-NASS (2011a) Acreage. 1949-1522. Retrieved October, 2011 from 

http://usda01.library.cornell.edu/usda/current/Acre/Acre-06-30-2011.pdf

USDA-NASS. (2011b) Corn, cotton, sorghum, soybean, and wheat planted acreage (1985 - 

2010). Retrieved September, 2011 from United States Department of Agriculture, 

National Agricultural Statistics Service 

http://www.nass.usda.gov/QuickStats/Create_Federal_All.jsp

USDA-NRCS. (2010) Zea mexicana. 

USDA-NRCS. (2011) Zea perrenis. 

USDA (2008) Farm and Ranch Irrigation Survey. 2007 Census of Agriculture. . Retrieved Aug. 

23, 2010, from 

http://www.agcensus.usda.gov/Publications/2007/Online_Highlights/Farm_and_Ranch_I

rrigation_Survey/fris08.txt

USDA. (2009).2007 Census of Agriculture: United States Summary and State Data. Last 

accessed from 

USDA (2011a) Crop Policies and Pilots - Biotechnology Endorsement. United States 

Department of Agriculture. Retrieved October, 2011 from 

http://www.rma.usda.gov/policies/bye.html

USDA (2011b) Federal Crop Insurance Corporation - Pilot Biotechnology Endorsement. United 

States Department of Agriculture. 

USDOL-(United-States-Department-of-Labor). (2005) A Demographic and Employment Profile 

of United States Farm Workers. . National Agricultural Workers Survey (NAWS) 2001-

2002. 

USFWS (2010) United States Fish and Wildlife Service. Retrieved March 2011, from 

http://www.fws.gov/

USGC (2006) Value Enhanced Corn Report 2005/2006. U.S. Grains Council. Retrieved from 

http://www.agmrc.org/media/cms/USGC_Value_Enhanced_Corn_Report_200_08C7959

C2B1E6.pdf
98

Ussiri DAN, Lal R, and Jarecki MK. (2009) Nitrous oxide and methane emissions from longterm tillage under a continuous corn cropping system in Ohio. Soil and Tillage Research, 

104(2), 247-255. 

Venterea RT, Burger M, and Spokas KA. (2005) Nitrogen Oxide and Methane Emissions under 

Varying Tillage and Fertilizer Management. Journal of Enviromental Quality, 34(5), 

1467-1477. 

Vercauteren KC and Hygnstrom SE. (1993) White-tailed deer home range characteristics and 

impacts relative to field corn damage. Presented at Great Plains Wildlife Damage Control 

Workshop Proceedings, University of Nebraska - Lincoln. 

Vogel J, Majewski M, and Capel P. (2008) Pesticides in rain in four agricultural watersheds in 

the United States. Journal of environmental quality, 37(3), 1101. 

Wanniarachchi SD, Voroney RP, Vyn TJ, Beyaert RP, and MacKenzie AF. (1999) Tillage 

effects on the dynamics of total and corn-residue-derived soil organic matter in two 

southern Ontario soils. Canadian Journal of Soil Science, 79(3), 473-480. 

Watrud LS, Lee EH, Fairbrother A, Burdick C, Reichman JR, Bollman M, Storm M, King G, 

and Van de Water PK. (2004) Evidence for landscape-level, pollen-mediated gene flow 

from genetically modified creeping bentgrass with CP4 EPSPS as a marker. Proceedings 

of the National Academy of Sciences of the United States of America, 101(40), 14533-

14538. 

Watson R (1994) Conservation Reserve Program: What Happens to the Land when the Contract 

Ends Northern Illinois University Law Review. 

Weber WE, Bringezu T, Broer I, Eder J, and Holz F. (2007) Coexistence Between GM and NonGM Maize Crops – Tested in 2004 at the Field Scale Level (Erprobungsanbau 2004). 

Journal of Agronomy and Crop Science, 193(2), 79-92. 

West TO and Marland G. (2002) A synthesis of carbon sequestration, carbon emissions, and net 

carbon flux in agriculture: comparing tillage practices in the United States. Agriculture, 

Ecosystems & Environment, 91(1-3), 217-232. 

Westcott P. (2007) US ethanol expansion driving changes throughout the agricultural sector. 

Amber Waves, 5(4), 10-15. 

Westgate ME, Otegui ME, and Andrade FH. (2004) Physiology of the corn plant. In CW Smith, 

J Betran and ECA Runge (Eds.), Corn: Origin, History, Technology, and Production). 

Hoboken, NJ: John Wiley and Sons. 

Wilkes H. (1967) Teosinte: the closest relative of maize. Bussey Inst., Harvard Univ., 

Cambridge. 

Wipff J and Fricker C. (2002) Gene flow from transgenic creeping bentgrass (Agrostis 

stolonifera L) in the Willamette Valley, Oregon. Australian Turfgrass Management 4.5, 

1-9. 

Wolfenbarger L, Naranjo S, Lundgren J, Bitzer R, and Watrud L. (2008) Bt Crop Effects on 

Functional Guilds of Non-Target Arthropods: A Meta-Analysis. PLoS One, 3(5), e2118. 

Wu J and Brorsen BW. (1995) The Impact of Government Programs and Land Characteristics on 

Cropping Patterns. Canadian Journal of Agricultural Economics/Revue canadienne 

d'agroeconomie, 43(1), 87-104. 

Yu T and Babcock B (2010) Are U.S. Corn and Soybeans Becoming more Drought Tolerant? 

Iowa State University. 
99

9 LIST OF PREPARERS 

Biotechnology Regulatory Services 

David Reinhold 

Assistant Director, 

Environmental Risk Analysis 

Program 

Khamkeo Vongpaseuth, Ph.D. 

Environmental Protection 

Specialist 

Diane Sinkowski, 

Environmental Protection 

Specialist 

Craig Roseland, Ph.D 

Senior Environmental Protection 

Specialist 

Subray Hegde, Ph. D., 

Biotechnologist 

ICF International

Christine Hartmann

Project Manager,  

Technical Document Lead

Project Management Professional (PMP) Certification

Professional Engineer (P.E.) Certification, Environmental

Engineering

M.E. Environmental Engineering, University of Maryland

B.S. Environmental Engineering, University of Maryland

9 years of experience in environmental impact

assessment, and 6 years of experience in managing and

preparing NEPA documents
100

John Hansel 

Senior NEPA Advisor, 

Technical Document Lead 

 J.D. Washington College of Law, American 

University 

 B.A. Economics, University of Wisconsin 

 30 years of experience in environmental impact 

assessment and preparing NEPA documents 

Michael Smith 

Senior NEPA Advisor 

 Ph.D. Sociology, Utah State University 

 M.A. Geography, University of Wyoming 

 B.A. Environmental Studies, University of California, 

Santa Cruz 

 17 years of experience in environmental impact 

assessment 

Ron Bass 

NEPA Compliance Review 

 J.D. Washington College of Law, American 

University 

 M.A. Environmental Planning, California State 

University Sacramento 

 B.A. , Anthropology, Ohio State University 

 30 years of experience in environmental impact 

assessment and preparing NEPA documents

Rhey Solomon 

NEPA Compliance Review 

 B.S. Watershed Management, University of Arizona 

 M.S. Watershed Hydrology, University of Arizona 

 35 years of experience in environmental analysis and 

management

Steve Froggett 

Technical Document Lead 

 Ph.D. Neuroscience and Behavior, University of 

Massachusetts 

 M.S. Biology, University of North Carolina 

 B.S. Biology and Psychology, Marietta College 

 9 years of experience working with government 

agencies, universities and the private sector on issues 

related to medical education, health care and food 

security

Erin Healy 

Technical Document Lead 

 Professional Geologist (PG) Certification, New 

Hampshire 

 M.Sc. Marine Science, University of South Carolina 

 B.A. Colby College, Maine 

 18 years experience in environmental assessment and 

water resource evaluation 
101

Audrey Ichida 

Technical Document Lead 

 Ph.D. Plant Molecular Biology, University of 

California, San Diego 

 B.A. Biology, Cornell College 

 Graduate and post doctoral work in plant molecular 

biology and 13 years of experience in risk assessment 

Kirsten Jaglo 

Technical Document Lead 

 Ph.D. Crop and Soil Science, Plant Breeding and 

Genetics, Michigan State University 

 B.A. Biology (minor in Chemistry), with honors, 

University of Minnesota 

 15 years of experience working with federal agencies, 

universities, and the private sector on issues related to 

genetic engineering 

Dave Johnson 

Technical Document Lead 

 B.S. Biology (minors in Chemistry and Geology), 

University of Minnesota 

 11 years experience in conducting aquatic resource 

delineations, habitat assessments, permitting 

assistance, and regulatory compliance

Jim Laurenson 

Technical Document Lead 

 M.S. Environmental Health Management with 

Technical Specialty in Risk Assessment, Harvard 

University School of Public Health 

 B.S. Animal Science and Pre-veterinary Medicine, 

University of Massachusetts 

 20 years of experience in conducting and managing 

environmental- and human health-related projects 

Jason Londo 

Technical Document Lead 

 Ph.D. Plant Biology, Washington University 

 B.S. Molecular Biology, Florida Institute of 

Technology 

 3 years of experience in plant population biology and 

ecology, and 6 years of experience in plant population 

genetics 

Meg McVey 

Senior Technical Review

 Ph.D. Animal Behavior and Ecology, The Rockefeller 

University 

 B.S. Zoology, University of North Carolina 

 30 years of experience in human health and 

ecological risk assessment 
102

APPENDIX A. FDA BIOTECHNOLOGY CONSULTATION NOTE TO THE FILE 

(BNF NO. 000116) 

Biotechnology Consultation - Note to the File 

Biotechnology Notification File BNF No. 000119 

DATE 

December 9, 2010 

Subject 

MON 87460, drought tolerant corn 

Keywords 

Maize; corn; Zea mays L.; drought tolerance; MON 87460; OECD unique identifier MON-8746Ø-4; cold 

shock protein B (CSPB) from Bacillus subtilis; neomycin phosphotransferase II (NPTII) from 

Escherichia coli, Monsanto 

Purpose 

This document summarizes our evaluation of Biotechnology Notification File (BNF) No. 

000116. In a submission dated December 19, 2008, the Monsanto Company (Monsanto) 

submitted a safety and nutritional assessment of the bioengineered corn MON 87460. Monsanto 

provided additional information in submissions dated April 9, May 1, June 1, June 29, July 7, 

August 10, September 10, November 2, 2009, and August 3, 2010. Monsanto is voluntarily 

consulting with the agency as discussed in the agency’s 1997 Guidance on Consultation 

Procedures for Foods Derived from New Plant Varieties. Here we discuss the outcome of the 

consultation, but do not intend to restate the information provided in the final consultation in its 

entirety. 

Intended Effects 

The intended effect of the modification in corn event MON 87460 is to reduce yield loss under 

water-limited conditions compared to conventional corn. To accomplish this objective, Monsanto 

introduced the gene (cspB) for cold shock protein B (CSPB) from B. subtilis. CSPB confers 

tolerance to water-limited conditions. Monsanto also introduced the gene (nptII) for neomycin 

phosphotransferase II (NPTII) protein from E. coli. NPTII was used as a selectable marker in the 

development of corn event MON 87460. The NPTII protein does not confer tolerance to waterlimited conditions. 

Regulatory Considerations 

The purpose of this evaluation is to assess whether the developer has introduced a substance 

requiring premarket approval as a food additive or has unintentionally adulterated the food with 

respect to the Federal Food, Drug and Cosmetic Act (FFDCA). 

Genetic Modification and Characterization 

Parental Variety 

Monsanto transformed the recipient LH59 (a non-transgenic conventional corn variety) callus 

tissue to obtain MON 87460. 
103

Transformation Plasmid and Method 

Monsanto described the development of corn event MON 87460 using Agrobacterium

tumefaciens-mediated transformation of corn embryo-derived tissue. The A. tumefaciens strain 

harbored the transformation vector PV-ZMAP595. The transforming vector carried a transfer 

DNA sequence comprised of both cspB and nptII expression cassettes. Following transformation, 

the corn tissue was transferred to medium containing the antibiotics carbenicillin to eliminate A. 

tumefaciens, and paromomycin (related to neomycin) to eliminate cells that were not 

transformed. 

Characteristics, Inheritance, and Stability of the Introduced DNA 

Monsanto provided genomic DNA blot (Southern) analyses to demonstrate that corn event MON 

87460 has one intact copy of the transfer DNA region comprised of tandem cspB and nptII

expression cassettes inserted in its genome. Monsanto provided genomic DNA blot analyses and 

polymerase chain reaction analyses in conjunction with DNA sequencing to verify the integrity 

of the integrated cspB and nptII genes along with their associated regulatory elements. Monsanto 

used genomic DNA blot analyses to demonstrate that MON 87460 does not contain any 

detectable DNA from the transformation vector, other than the transfer DNA region. 

Monsanto presented genomic DNA blot analyses to demonstrate the stability of the inserted cspB 

and nptII expression cassettes across multiple generations of corn event MON 87460. Monsanto 

presented Chi-square analyses of the segregation patterns across multiple generations of corn 

event MON 87460 to demonstrate the stable Mendelian inheritance of the transfer DNA region 

containing both the cspB and the nptII cassettes. 

Monsanto assessed the inserted DNA sequence for any potential unintended open reading frames 

(ORFs) that might encode proteins. Monsanto identified several putative polypeptides of at least 

eight amino acids that could be expressed. Monsanto performed bioinformatic analyses to 

compare sequences within these putative polypeptides to those of known toxins and allergens in 

standard toxin, allergen and protein databases. Monsanto found no similarity to any known 

allergen or toxin. 

Protein Characterization 

Function and expression levels of introduced proteins 

Monsanto describes the CSPB protein produced in corn event MON 87460 as identical to the 

native CSPB protein produced in B. subtilis except for one amino acid introduced for cloning 

purposes. Bacterial cold shock proteins (CSP) are hypothesized to function by binding to RNA 

secondary structures, thus reducing the free energy required for unfolding misfolded RNA. CSPs 

are classified as RNA chaperones. Monsanto notes that similar cold shock domain-containing 

proteins are also present in plants where they appear to play a role in conferring stress tolerance. 

Monsanto describes the function of the NPTII protein as being a selectable marker used in the 

development of corn event MON 87460. NPTII phosphorylates neomycin and related antibiotics, 

thus inactivating them. 

Monsanto estimated the levels of CSPB and NPTII proteins in corn event MON 87460 from both 

well-watered (i.e., received adequate water throughout the growing season) and water-limited 

plants grown in the field. Monsanto noted that given the genetic construct of the transferred 

DNA, both CSPB and NPTII proteins would be expected to be present in all tissues. Using 
104

standard biochemical techniques, Monsanto reports CSPB protein being present in all tissues 

tested. Monsanto reports NPTII protein also being present in all tissues tested, with the exception 

of mature grain where it was below the detection method’s limit of quantitation (where the limit 

of quantitation is 0.0047 micrograms per gram of tissue on a fresh weight basis). 

Potential Toxicity of the Introduced Proteins 

Monsanto assessed the potential for toxicity for both CSPB and NPTII proteins. Regarding 

CSPB, Monsanto noted that the source of the cspB gene is B. subtilis, a microorganism used as 

the donor organism for several enzyme preparations used in food manufacturing applications. In 

support of the safety of B. subtilis used in such food applications, Monsanto cited several 

published studies as well as the opinions of expert scientific bodies. In support of the safety of the 

CSPB protein, Monsanto noted that it is homologous to several proteins from microbial and plant 

sources present in the human diet. Using the CSPB protein sequence, Monsanto performed 

bioinformatic analyses to look for similarities between CSPB and proteins known to be toxic or 

bioactive and found no such similarities. Monsanto also conducted an acute oral toxicity study in 

mice (single dose of 4.7 milligrams/kilogram) using E. coli-produced CSPB protein. Monsanto 

noted no treatment-related adverse effects. Given the totality of the evidence, Monsanto 

concluded that the CSPB protein from corn event MON 87460 is unlikely to exhibit toxic effects 

when incorporated into food or feed. 

Regarding NPTII, Monsanto stated that the source of the nptII gene is E. coli K-12. NPTII, also 

referred to as APH(3')II, is regulated as a food additive under 21 CFR 173.170 and 21 CFR 

573.130 for use as a processing aid in the development of new varieties of tomato, oilseed rape 

and cotton. Scientific studies and evaluations regarding the use of NPTII in new plant 

development have been performed since FDA filed the food additive petition for these uses. In 

reviewing NPTII, FDA concluded that NPTII does not have any properties that would 

distinguish it toxicologically from any other phosphorylating enzymes in the food supply. Using 

the NPTII protein sequence, Monsanto performed bioinformatic analyses, which found no 

similarities between NPTII and proteins known to be toxic or bioactive and provided additional 

citations supporting its safety. Given the totality of the evidence, Monsanto concluded that the 

NPTII protein from corn event MON 87460 is unlikely to exhibit toxic effects when consumed 

in food or feed. 

Assessment of the Potential for Allergenicity of the Introduced Proteins 

Monsanto evaluated the potential for allergenicity of CSPB and NPTII proteins. For CSPB and 

NPTII proteins, bioinformatics analyses of sequence similarities using standard methods, 

including the allergen database in conjunction with the FASTA sequence alignment tool, and an 

eight-amino acid sliding window search (ALLERGENSEARCH) revealed no significant 

homology to known allergens. For the CSPB protein, in vitro gastric and intestinal digestibility 

studies using standard methods did not identify significant resistance to proteolysis. For the 

NPTII protein, Monsanto cites an FDA draft guidance document to support its conclusion that 

the NPTII protein poses no allergenic risk [Guidance for Industry: Use of Antibiotic Resistance 

Marker Genes in Transgenic Plants (Draft Guidance, issued September 4, 1998)]. In this draft 

guidance, FDA states that NPTII protein is known to be rapidly degraded under simulated gastric 

conditions, is neither glycosylated nor heat-resistant and lacks homology to known food allergens 

using several databases. FDA concludes that there are no allergenicity concerns. 
105

Food & Feed Use 

Corn (Zea mays L.) originated in Mexico and was grown as a food crop as early as 2700 B.C. 

Today, corn is grown worldwide for food, feed, and industrial uses. Corn grain is used in food 

primarily in the form of processed products, such as high fructose corn syrup, cereals, oil, meal, 

flour, starch, and grits. Corn is a source of nutritionally important amino acids (methionine and 

cystine), carotenoids, and vitamin E. Corn oil is rich in polyunsaturated fatty acids and is used 

mainly as a salad and cooking oil and in margarine production. 

Corn is also used in animal feed. Corn grain is primarily fed to cattle, poultry, and swine either as 

intact or processed grain or as dry or wet milling byproducts, but may be a component of most 

animal feeds. Corn silage (entire above ground portion of the corn plant that is harvested prior to 

maturation) is primarily fed to ruminants. 

Composition 

Scope of Analysis 

Monsanto analyzed the composition of forage and grain from the MON 87460 corn and 

compared it with its near isogenic parental line (a non-transgenic corn variety with a similar 

genetic background to MON 87460, hereafter referred to as the comparator control line). Two 

field studies were summarized in Monsanto’s submission (United States (U.S.) and Chilean 

studies). 

 In the U.S. study, Monsanto evaluated the composition of forage and grain from MON 

87460, its comparator control line, and from a total of eighteen commercial nontransgenic corn varieties. 

 In the Chilean study, Monsanto evaluated the composition of forage and grain from 

MON 87460, its comparator control line, and sixteen commercial non-transgenic corn 

varieties grown under water-limited or irrigation conditions. 

Monsanto used the data derived from the reference varieties to generate a 99% tolerance1 

interval for each component. Monsanto states that these data illustrate the natural variability in 

commercially grown corn varieties grown under similar field conditions. 

Study Design - Compositional Analyses 

As described by Monsanto, corn event MON 87460 and the comparator control line were grown 

at six replicated field sites in corn production regions in the U.S. during the 2006 growing season. 

At the same sites, three unique conventional commercial hybrid lines were also grown at each of 

the six sites, thus providing a total of 18 commercial references for compositional analyses of 

forage and grain tissue samples. Plants in all six sites were grown under commercially acceptable 

agronomic practices typical for the area, with four sites being rain-fed and two receiving 

supplemental irrigation. At each field site, seed was planted in a randomized block design with 

three replicates per block. Forage and grain samples were collected from corn event MON 87460 

and the comparator control line from all three blocks. Forage and grain samples were collected 

from the three conventional commercial hybrid lines from a single block. Samples of forage at 

the early dent plant growth state and grain at physiological maturity were collected from all plots 

and analyzed for nutritional components, toxicants, and anti-nutrients. Monsanto measured and 

evaluated seven components in forage and 68 in grain. Compositional analyses of the forage 

samples included measurement of moisture, crude fat, crude protein, ash, carbohydrates by 
106

calculation, acid detergent fiber (ADF), neutral detergent fiber (NDF), calcium, and phosphorus. 

Compositional analyses of the grain samples included measurement of moisture, crude fat, crude 

protein, ash, carbohydrates by calculation, ADF, NDF, total dietary fiber (TDF), amino acids 

(18), fatty acids (C8-C22), minerals (calcium, copper, iron, magnesium, manganese, phosphorus, 

potassium, sodium, and zinc), vitamins (vitamin B1, vitamin B2, vitamin B6, vitamin E, niacin, 

and folic acid), and key secondary metabolites (furfural, p-coumaric acid, and ferulic acid), antinutrients (raffinose and phytic acid). 

Monsanto also described field trials from the 2006-2007 growing season in commercial corn 

production regions of Chile. According to Monsanto, these four sites are well-suited to growing 

corn, but typically do not receive any rainfall so crops receive water only through controlled 

irrigation. Monsanto planted corn event MON 87460, the comparator control line, and four 

unique commercial conventional hybrid corn lines per site, providing a total of 16 commercial 

references for compositional analyses of forage and grain samples. At the Chilean sites, 

Monsanto used a strip plot design with three replicates per site with the water level treatment 

(either well-watered for optimal growth using irrigation or water-limited to impose a drought 

stress during a critical stage of growth) as the whole plot and substance type as the subplot to 

allow for a comparison of plants grown under the two different water level treatments. Monsanto 

described the whole plot factor as arranged as a randomized complete block design and the splitplot factor consisting of corn event MON 87460, the comparator control line, and the 

conventional commercial hybrid lines. Monsanto collected forage (early dent stage) and grain 

samples (at physiological maturity) from corn event MON 87460 and the comparator control line 

from all three blocks for each treatment and forage and grain samples from the four conventional 

commercial hybrid lines from a single block for each irrigation treatment. 

For the U.S. study, statistical assessments of the compositional data were conducted using mixed 

model analysis of variance on each individual site and a comparison across all sites, referred to as 

the combined site analysis. For the Chilean field trials, Monsanto described statistical 

considerations to assess the effects of the two irrigation treatments. As described by Monsanto, 

for a site to be considered in the combined-site analysis, the commercial conventional hybrid 

lines must have exhibited a phenotypic response indicative of the treatment. For the waterlimited plants, this response was defined as a minimum of a 15 percent reduction in yield. In 

summary, for the Chilean field trials, there were four sets of statistical analyses made for each 

treatment, three used data from each of the field sites and the fourth used data from a combinedsite analysis 

Statistical differences at the 5 percent level (P<0.05) were declared to be significant. Where 

statistically significant differences between corn event MON 87460 and the comparator control 

line were observed, Monsanto notes that all mean component values of the test and control 

substances were within the 99 percent tolerance interval established from the commercial 

references. 

Results of analyses: 

Monsanto made the following observations and conclusions regarding the results of the levels of 

components measured in forage and grain from corn event MON 87460. For the U.S. field trials, 

77 different analytical components were measured, 15 had more than 50 percent of the 
107

observations below the assay limit of quantitation. These components are known to be present at 

low levels in corn grain. Noted below are statistically significant differences detected for the 

combined-site analysis only. Similarly, for the Chilean well-watered field trials, of the 77 

different analytical components measured, 16 had more than 50 percent of the observations 

below the assay limit of quantization. 

Compositional analysis of corn forage 

Monsanto reported no statistically significant differences in moisture, crude fat, crude protein, 

ash, carbohydrates by calculation, ADF, NDF, calcium, and phosphorus levels between MON 

87460 and the comparator control line in the U.S study. Similarly, there were no statistically 

significant differences in moisture, crude fat, crude protein, ash, ADF, NDF, calcium, and 

phosphorus levels in the water-supplemented treatment in Chile. Carbohydrates by calculation 

was higher in forage obtained from MON 87460 when compared to the comparator control line 

in corn grown under water-supplemented treatment, but the values for MON 87460 and the 

comparator control line fell within the 99 percent tolerance interval for conventional varieties 

grown under similar conditions. Total fat was higher in forage obtained from MON 87460 when 

compared to the comparator control line in corn grown under water-limited conditions, but the 

values for MON 87460 and the comparator control line fell within the 99 percent tolerance 

interval for conventional varieties grown under similar conditions. 

Compositional analysis of corn grain 

U.S. Study: 

Monsanto reported no statistically significant differences in moisture, crude fat, crude protein, 

carbohydrates by calculation, ADF, NDF, TDF, minerals (calcium, copper, iron, magnesium, 

manganese, phosphorus, potassium, and zinc), all 18 amino acids, 7 fatty acids (palmitic, 

palmitoleic, oleic, linoleic, linolenic, arachidic, and behenic acids), 6 vitamins, phytic acid, 

raffinose, ferulic acid, and p-coumaric acid between MON 87460 and the comparator control 

line. Ash and stearic fatty acid contents were statistically higher in MON 87460 than the 

comparator control line, but the MON 87460 and comparator control line values fell within the 

99% tolerance interval for conventional varieties grown under similar conditions. Eicosenoic 

fatty acid content was statistically lower in MON 87460 when compared to the comparator 

control line and both of these values were slightly lower than the lowest value for the 99% 

tolerance interval. 

Chilean Water-Supplemented Sub-plot: 

Monsanto reported no statistically significant differences in moisture, crude protein, ash, 

carbohydrates by calculation, ADF, NDF, TDF, minerals (except for magnesium), all 18 amino 

acids, the 8 detectable fatty acids, 6 vitamins, phytic acid, raffinose, ferulic acid, and p-coumaric 

acid between MON 87460 and comparator control line. Ash and magnesium contents were 

statistically higher in MON 87460 than the comparator control line, but the values for MON 

87460 and the comparator control line fell within the 99% tolerance interval for conventional 

varieties grown under similar conditions. 

Chilean Water-Limited Sub-plot: 

Monsanto reported no statistically significant differences in moisture, crude fat, crude protein, 

ash, carbohydrates by calculation, ADF, NDF, TDF, 8 minerals, 18 amino acids, fatty acids 

(except eicosenoic acid), 6 vitamins, phytic acid, raffinose, ferulic acid, and p-coumaric acid 

between MON 87460 and comparator control line. Although the values for eicosenoic acids were 
108

statistically different, the values were numerically (at two decimal points) the same and these 

values fell within the 99 percent tolerance interval for conventional varieties grown under similar 

conditions. 

Summary of Compositional Analyses 

As noted above, in Monsanto’s combined site analyses, a few statistically significant differences 

were found in the comparisons of corn event MON 87460 and the comparator control line. Of 

the statistically significant differences detected, all mean component values were within the 99 

percent tolerance level established from the commercial references. In addition, the mean levels 

for each of these components were within the range of values reported in either the International 

Life Science Institute (ILSI) Crop Composition Database (ILSI 2006), the OECD consensus 

document (OECD, 2002), or both. Monsanto concluded that the differences were within the 

natural variability of corn. 

Conclusion 

FDA evaluated Monsanto’s submission to determine whether the developer’s product raises any 

safety issues with respect to the intended modification or with respect to the food itself, as 

discussed in the agency’s 1992 Policy Statement on New Plant Varieties. Based on the 

information provided by the company and other information available to the agency, FDA did 

not identify any issues under Sections 402 and 409 of the Federal Food, Drug and Cosmetic Act 

that would require further evaluation at this time. 

Monsanto has concluded that its drought tolerant corn variety, corn event MON 87460 (MON8746Ø-4) and the foods and feeds derived from it are as safe as conventional corn varieties and 

with the exception of the drought tolerance trait, are not materially different in composition or 

any other relevant parameter from other corn varieties now grown, marketed, and consumed in 

the U.S. At this time, based on Monsanto’s data and information, the agency considers 

Monsanto’s consultation on MON 87460 corn to be complete 

Susan Carlson 

1

A 99 percent tolerance interval represents, with 95 percent confidence, 99 percent of the values 

contained in the population of commercial conventional corn varieties 
109

APPENDIX B. POLLEN- AND GENE-MEDIATED GENE FLOW 

B.1. Gene Flow among Corn Cultivars 

As reviewed by Mallory-Smith and Zapiola (2008), several factors are necessary for and can 

affect levels of pollen-mediated and seed-mediated gene flow between plant populations. Table 

B-1 lists and describes the many factors that affect gene flow. 

Table B-1: Factors that contribute to gene flow due to pollen and seed 

Pollen mediated gene flow Seed mediated gene flow 

Requires: 

 Coexistence of pollen donor and receptors 

 Overlapping flowering phenology 

 Successful pollination and fertilization 

 Establishment 

Requires: 

 Dispersal – weather, animals, humans 

Factors that increases pollen gene flow: 

 Feral crop populations and volunteers 

 Sexually compatible wild relatives 

 Out-crossing 

 Self-incompatibility 

 Large pollen source 

 Large pollen production 

 Strong winds (wind pollination) 

 Lightweight pollen 

 Insect populations (insect pollination) 

 Long pollen viability 

 Favorable weather conditions for pollen viability 

(low temp and high humidity) 

Factors that increase seed gene flow: 

 Feral crop populations and volunteers 

 Small seeds 

 Lightweight seeds 

 High seed production 

 Seed shattering 

 Seed dormancy 

 Use of commingled seed 

 Seed transport 

 Improperly cleaned machinery 

Factors that decrease pollen gene flow: 

 Isolation of populations 

 Non-synchronous flowering time 

 Border rows 

 Volunteer control 

Factors that decrease seed gene flow: 

 Certified seed 

 Proper machine cleaning between fields 

 Proper transport of seeds 

 Correct product labeling 

 Volunteer control 

Source: Adapted from Mallory-Smith and Zapiola 2008. 

B.1.1 Pollen-mediated Gene Flow 

Overview of gene flow 

For gene flow to occur between corn cultivars or varieties, the pollen donor and pollen receptor 

plants must be sexually compatible, flowering phenology must overlap between source and sink 

populations, pollen transfer must occur, embryo/seeds must develop, and hybrid seed must 

disperse and establish. Corn is a monoecious (both male and female flowers on the same plant), 

out-crossing, wind- pollinated crop that produces abundant, large, and heavy pollen. 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 restricted between 

genetically modified, conventional, and organic corn. However, spatial and temporal isolation 
110

can be an effective barrier to gene exchange between corn crop cultivars (Mallory-Smith and 

Zapiola, 2008). In addition, current practices for maintaining the purity of hybrid seed 

production in corn are typically successful for maintaining 99 percent genetic purity (Ireland et 

al., 2006). The following are properties affecting pollen-mediated gene flow from corn: 

 Physical properties of corn plants: The male and female reproductive structures of 

corn are physically separated and contribute to out-crossing. The male structure, the 

tassel, is at the top of the corn plant. The female structures, the silks, form at axillary 

buds lower on the plant at leaf junctions. 

 Properties of corn pollen: Corn pollen is very large and heavy (in relation to other grass 

species) and, given its large size, pollen is primarily dispersed downwind from tassels 

into adjacent rows of planted corn. Once corn pollen is released, its viability depends on 

environmental conditions. Viability can be low when conditions are dry  only 1 to 4 

hours (Bannert, 2006)  or remain viable for up to 24 hours after shedding under 

conditions of cool temperature and high humidity (Luna et al., 2001). 

 Flower synchrony: Because of the limited viability of corn pollen – 1 to 24 hours, as 

stated above  and short flowering period of corn plants, synchronization of pollen 

dispersal and flowering time is critical for the occurrence of pollen mediated-gene flow 

(Mallory-Smith and Zapiola, 2008). Cross-pollination between neighboring corn fields 

can be effectively reduced, if not prevented, by desynchronizing flowering between fields 

by altering planting dates. Halsey et al. (2005) demonstrated that while gene flow could 

be detected at 0.01 percent at 1,640 feet (500 meters) from source populations when 

flowering time was synchronized, the farthest distance where this level of gene flow 

could be detected was 203 feet (62 meters) from source populations when flowering was 

desynchronized. 

 Insect pollination: Insect pollinators (e.g., honeybees) often collect maize pollen from 

tassels for feeding and breeding of their larva, but because the female structures lack 

nectar production and other attractants, bees typically do not visit the silks. When bee 

populations are established before corn flowering, bees often avoid pollen collection from 

corn even when corn plants are close, because of bee preference for the flowers of other 

plant species. Therefore, insects, and honeybees in particular, do not usually contribute 

to fertilization and cross-pollination (Bannert, 2006). 

 Wind pollination: Wind pollination is the primary and most effective mechanism for 

fertilization and cross-pollination, or gene flow, between corn plants. Variation in 

flowering timing within corn crop fields can increase the flowering window of a given 

corn field. However, to maximize yield, most corn varieties have been selected to have a 

synchronous flowering time within the same field. Depending on genotypic and 

environmental factors, tassels typically shed pollen for 2 to 14 days (Bannert, 2006). 

Pollen is typically released during dry and drying conditions, and often released in 

advance of changing atmospheric conditions (Bannert 2006). Tassel maturity and pollen 

release can occur on corn plants exposed to drought conditions, but silk deployment is 

delayed, reducing the fertilization and pollination window of drought-affected corn plants 

(Hall and Twidwell, 2002). Rain is disadvantageous for pollen dispersal and frequent 

rainy weather can reduce fertilization in corn crops. 
111

 Pollen migration distance: As stated above, corn pollen is very large and heavy (in 

relation to other grass species) and is primarily dispersed downwind from tassels into 

adjacent rows of planted corn. Thus, isolation distances can reduce movement of most of 

the pollen between two corn fields, but based on the evidence from these studies, 

complete confinement is not likely. Generally, most of the pollen moves within 9 to 49 

feet (6 to 15 meters) of the donor plant, although wind can carry pollen for much greater 

distances. Numerous studies have examined the rate of pollen-mediated gene flow 

between corn populations (reviewed in Sanvido et al. 2008). Because of the multitude of 

different experimental designs results vary between studies, but most demonstrate that 

cross-fertilization rates drop below 1 percent within 33 feet (10 meters) of source plants, 

and levels of cross-fertilization (gene flow) was maintained below 0.5 percent within the 

first 164 feet (50 meters) (Sanvido et al., 2008). Early studies examining gene flow from 

corn demonstrated gene flow up to 1,650 feet [503 meters] from source fields (Jones and 

Brooks, 1950), but many more recent studies suggest that gene flow distance follows an 

exponential decrease and diminishes greatly with increasing distance from source fields 

more than 656 feet [200 meters]) (Ireland et al., 2006; Sanvido et al., 2008), but limited 

instances of long-distance (more than 1,148 feet [350 meters]) low-level gene flow can 

occur when weather conditions, such as high winds, cool temperatures, and high 

humidity, contribute to increased pollen viability and dispersal (Bannert 2006). 

 Border rows and field size: Planting of border rows at corn fields can contribute to 

reductions in gene flow, but cannot prevent it because turbulent wind currents can 

contribute to pollen dispersal beyond sink-field borders and some studies have 

demonstrated higher rates of gene flow from adjacent fields into field borders (Ireland et 

al., 2006). Luna et al. (2001) examined the effects of varied isolation distances between 

maize plants in Mexico, and found that low levels of cross-pollination occurred at 328 

feet (100 meters) and that no pollination occurred at distances beyond 656 feet. Other 

researchers have shown that pollination can be as high as 60 percent between contiguous 

rows, but that from more remote rows it decreased with increasing distance such that no 

outcrosses were found 105 feet (32 meters) away from the pollen source (Castillo and 

Goodman, 1997). In large, field-based assessments of corn gene flow in the United 

Kingdom, Weekes et al. (2007) demonstrated that gene flow rates decreased rapidly with 

increasing distance from the GE source, but can be detected at distances up to and 

including 656 feet from the GE source. In addition, computer-based models predict that 

rates of gene flow can increase as the size of GE fields increase (Kuparinen et al., 2007). 

 Pollen competition: A comparison of the risk of open-pollinated corn cultivation (nonhybrid) versus hybrid corn cultivation suggests that cross-fertilization rates are higher in 

open pollination production (Sanvido et al., 2008). However, research by Goggi et al. 

(2007) evaluated the effects of pollen competition (gene flow from a source into an 

established stand of corn) on gene flow between GE and non-GE corn. At distances of 

more than 328 feet (100 meters), the out-crossing frequency between GE corn and nonGE corn decreased to below 0.1 percent in fields with reduced pollen competition and 

below 0.03 percent in fields with normal pollen competition. These results indicate that 

when local pollen levels are low, incoming pollen has a competitive advantage, which 

results in a notably greater frequency of out-crossing than when the local pollen is 

abundant. Accordingly, large corn donor fields can contribute to greater pollen flow into 

small recipient fields as a result of pollen competition (Jemison and Vayda, 2002). 
112

Similarly, because of the low production of pollen in hybrid corn fields, low pollen 

competition could contribute to higher rates of cross-fertilization if temporal or spatial 

isolation is not observed (Mallory-Smith and Zapiola, 2008). 

B.1.2 Seed-mediated Gene Flow 

Overview of seed dispersal 

For gene flow to occur via seeds and result in feral populations of corn, seeds must disperse and 

establish in new habitats. Through thousands of years of selective breeding by humans, corn has 

been extensively modified to depend on human cultivation for survival. Several key weedy traits 

that would contribute to crop escape, traits associated with ferality and volunteerism, have been 

selectively reduced in corn, resulting in a crop species not equipped for survival without 

management (Gould, 1968). Also, several traits greatly reduce the ability of corn to disperse via 

seeds. Humans have selected corn to produce seeds that do not shatter and cannot disperse from 

the cob, and corn seeds are tightly bound within a protective sheath of leaves, or husk (MallorySmith and Zapiola, 2008). Corn seeds also lack dormancy, preventing easy persistence between 

seasons in fields or in the weed seed bank. While corn grains or cobs left in fields after harvest 

can result in volunteers in the following year, because of the tightly bound nature of the corn 

seeds, competition between siblings can reduce fitness. The following are properties affecting 

seed-mediated gene flow from corn: 

 Human mediated seed dispersal: Human-influenced seed-mediated gene flow in corn 

could occur as a result of seed mixing following improper cleaning of field machinery, 

and improper seed purity and certification methods. As described in Section 3.3.5, corn 

seed is almost exclusively produced as hybrid lines, with great care taken to maintain 

parental stock lines. However, in almost all current corn production, corn is planted as 

hybrid seed to reduce intra-field variation in plant height, flower synchrony, and harvest. 

Because of the nearly exclusive cultivation of hybrid lines that must be produced yearly 

by intentional hybridization between two different inbred lines, corn seed is not saved in 

the United States from previous harvests for replanting in subsequent years; instead, it 

purchased each year (Fernandez-Cornejo, 2004). Feral corn plants can sometimes occur 

along roadsides as a result of seed spill during transport, but do not typically persist 

because of the same factors that reduce persistence in fields. Therefore, the purity of 

seed stocks purchased in each year would determine seed-mediated gene flow into corn 

fields. 

 Animal mediated seed dispersal: Several different animal species (e.g., deer, wild boar, 

and waterfowl) will consume scattered corn if it is present, but dispersal of viable seeds is 

limited. Research by scientists in Germany has demonstrated that corn seeds do not 

survive digestion by deer, and survival of viable GE corn seeds through wild boar is 

extremely limited (0.009 percent) (Guertler et al., 2008; Wiedemann et al., 2009). In 

addition, research by Cummings et al. (2008) demonstrated that passage of viable corn 

seed does not occur through mallard ducks and rock pigeons. 

Seed traits and weediness of corn: The domestication history of corn has resulted in the 

production of a plant species that has a greatly reduced ability to persist and survive outside of 

human cultivation. Lack of seed dormancy prevents accumulation of corn in weed seed banks, 

and lack of seed shatter and encasement within corn husks prevents dispersal of seeds. 
113

Therefore, corn is not suited to survive without human management and is not typically 

described as a weed (Baker, 1965; Galinat, 1988; Keeler, 1989). Corn is not present as a noxious 

weed on federal lists (Crockett, 1977; Holm et al., 1979; Muenscher, 1980; USDA-APHIS, 

2010) though the Southern Weed Science Society lists it as a weed (USDA-NRCS 2010). 

Volunteer corn can sometimes overwinter and occur in fields following cultivation and crop 

rotation, particularly with soybeans, but does not persist and can be controlled using mechanical 

or chemical measures. In addition, persistent populations of feral corn are not common along 

transportation routes or other weedy environments (Mallory-Smith and Zapiola, 2008). Based on 

the traits of modern corn and the factors necessary for corn to establish in new populations, it is 

not likely that gene flow will occur via seeds into new feral corn populations. 

References 

Baker HG. (1965) Characteristics and modes of origin of weeds. In HG Baker and GL Stebbins 

(Eds.), The Genetics of Colonizing Species (pp. 147-168). Berkeley, CA: Department of 

Botany, University of California, Berkeley, USA. 

Bannert M. (2006) Simulation of transgenic pollen dispersal by use of different grain colour 

maize. Thesis. SWISS FEDERAL INSTITUTE OF TECHNOLOGY ZURICH. 

Castillo G and Goodman M. (1997) Research on gene flow between improved maize and 

landraces. 

Crockett L. (1977) Wildly successful plants: a handbook of North American weeds. Macmillan. 

Cummings JL, Handley LW, Macbryde B, Tupper SK, Werner SJ, and Byram ZJ. (2008) 

Dispersal of viable row-crop seeds of commercial agriculture by farmland birds: 

implication for genetically modified crops. Environ. Biosafety Res., 7(4), 241-252. 

Fernandez-Cornejo J. (2004).The seed industry in U.S. agriculture: An exploration of data and 

information on crop seed markets, regulation, industry structure, and research and 

development. United States Department of Agriculture, Economic Research Service, 

Washington, D.C. Last accessed Aug. 23, 2010, from 

http://www.ers.usda.gov/publications/aib786/aib786c.pdf

Galinat W. (1988) The origin of corn. In GF Sprague and JW Dudley (Eds.), Corn and Corn 

Improvement (pp. 1-27). Madison, WI: American Society of Agronomy, Inc., Crop Soil 

Science Society of America, Inc., and the Soil Science Society of America, Inc. 

Goggi A, Lopez-Sanchez H, Caragea P, Westgate M, Arritt R, and Clark C. (2007) Gene flow in 

maize fields with different local pollen densities. International Journal of 

Biometeorology, 51(6), 493-503. 

Gould F. (1968) Grass Systematics. New York, New York: McGraw Hill, NJ. 

Guertler P, Lutz B, Kuehn R, Meyer H, Einspanier R, Killermann B, and Albrecht C. (2008) Fate 

of recombinant DNA and Cry1Ab protein after ingestion and dispersal of genetically 

modified maize in comparison to rapeseed by fallow deer (Dama dama). European 

Journal of Wildlife Research, 54(1), 36-43. 

Hall RC and Twidwell EK (2002) Effects of drought stress on corn production. Cooperative 

Extension Service. Retrieved from http://www.sdstate.edu/sdces/store/Publications/pubdetails.cfm?customel_datapageid_858688=872114

Halsey M, Remund K, Davis C, Qualls M, Eppard P, and Berberich S. (2005) Isolation of maize 

from pollen-mediated gene flow by time and distance. Crop Science, 45(6), 2172. 
114

Holm L, Pancho J, Herberger V, and Plucknett DL. (1979) A geographical atlas of world weeds. 

471-04393. 

Ireland D, Wilson Jr D, Westgate M, Burris J, and Lauer M. (2006) Managing reproductive 

isolation in hybrid seed corn production. Crop Science, 46(4), 1445. 

Jemison J and Vayda M. (2002) Cross pollination from genetically engineered corn: wind 

transport and seed source. 

Jones M and Brooks J. (1950) Effectiveness of distance and border rows in preventing 

outcrossing in corn. Oklahoma Agricultural Experiment Station Technical Bulletin No, 3-

18. 

Keeler KH. (1989) Can genetically engineered crops become weeds? Biotechnology, 7(11), 

1134-1139. 

Kuparinen A, Schurr F, Tackenberg O, and O'Hara R. (2007) Air-mediated pollen flow from 

genetically modified to conventional crops. Ecological applications, 17(2), 431-440. 

Luna V, Figueroa M, Baltazar M, Gomez L, Townsend R, and Schoper J. (2001) Maize Pollen 

Longevity and Distance Isolation Requirements for Effective Pollen Control. Crop 

Science, 41(5), 1551-1557. 

Mallory-Smith C and Zapiola M. (2008) Gene flow from glyphosate-resistant crops. Pest 

management science, 64(4), 428-440. 

Muenscher W. (1980) Weeds, Reprinted. Cornell University Press, Ithaca, New York. 

Sanvido O, Widmer F, Winzeler M, Streit B, Szerencsits E, and Bigler F. (2008) Definition and 

feasibility of isolation distances for transgenic maize cultivation. Transgenic research, 

17(3), 317-335. 

USDA-APHIS (2010) Plant Pest Risk Assessment for MON 87460 Corn. Riverdale, MD: 

APHIS - Animal and Plant Health Inspection Service. Retrieved from 

http://www.aphis.usda.gov/biotechnology/not_reg.html

Weekes R, Allnutt T, Boffey C, Morgan S, Bilton M, Daniels R, and Henry C. (2007) A study of 

crop-to-crop gene flow using farm scale sites of fodder maize (Zea mays L.) in the UK. 

Transgenic research, 16(2), 203-211. 

Wiedemann S, Lutz B, Albrecht C, Kuehn R, Killermann B, Einspanier R, and Meyer H. (2009) 

Fate of genetically modified maize and conventional rapeseed, and endozoochory in wild 

boar (Sus scrofa). Mammalian Biology-Zeitschrift fur Saugetierkunde, 74(3), 191-197. 
115

APPENDIX C. CHARACTERISTICS MEASURED FOR PHENOTYPIC, 

AGRONOMIC, AND ENVIROMENTAL INTERACTIONS ASSESSMENT OF MON 

87460 

Characteristic 

Characteristic 

Measured 

Evaluation 

Timing 

Evaluation Description (measurement 

endpoints 

Plant phenotypic 

and agronomic 

characteristics 

Dormancy, 

Germination 

After 4, 7, and 12 days Percent normally germinated, abnormally 

germinated, viable hard (dormant), dead, and 

viable firm swollen seed 

Seedling vigor Stage V2–V4 Rated as: 1-3 = above average vigor, 7-9 = 

below average vigor (2007 scale) or, where 0 

= dead, and 9 = above average vigor (2006 

scale) 

Early stand count Stage V2–V4 Number of emerged plants per plot 

Final stand count Pre-harvest Number of plants per plot

Stay green Maturity Rated as: 1 = 90-100% green tissue, 5 = 50-59% 

green tissue, 9 = 0-19% green tissue (2007 rating 

scale) or, 0 = entire plant dried, and 9 = entire 

plant green (2006 rating scale)

Ear height Maturity Distance from the soil surface at the base of the 

plant to the ear attachment node

Plant height Maturity Distance from the soil surface at the base of the 

plant to the flag leaf collar

Stalk lodged plants Pre-harvest Number of plants per plot broken below the 

ear

Root lodged plants Pre-harvest Number of plants per plot leaning at the soil 

surface at >30° from the vertical

Days to 50% pollen shed Pollen shed Days from planting until 50% of the plants have 

begun to shed pollen

Days to 50% silking Silking Days from planting until 50% of the plants have 

silks exposed

Pollen viability Tasseling Viable and nonviable pollen based on pollen 

grain staining characteristics

Pollen morphology Tasseling Diameter of viable pollen grains

Grain moisture Harvest Moisture percentage of harvested shelled grain

Test weight (lb/bu) Harvest Test weight of harvested shelled grain
116

Characteristic 

Characteristic 

Measured 

Evaluation 

Timing 

Evaluation Description (measurement 

endpoints 

Yield (bu/ac) Harvest Harvested weight of shelled grain, adjusted to 

15.5% moisture

Dropped ears Pre-harvest Number of mature ears dropped from plants

Plant 

environmental 

interactions 

Insect, disease and abiotic 

stressors 

Variable, from planting 

to harvest 

Qualitative assessment of each plot, with rating 

on a 0-9 scale for plant-insect, plant-disease, and 

plant response to abiotic stressor interactions

Abiotic stress tolerance to 

drought, cold, heat, and 

salt 

Stage V2–V6 Conducted in greenhouse and growth chamber 

experiments. Measurements included plant 

height, growth stage, vigor, chlorophyll content, 

and biomass.

Volunteer potential After fall planting and 

following spring 

Number of plants present as volunteer corn in 

plots

Survival outside of 

cultivation 

Variable, from planting 

to harvest 

Variable, phenotypic assessments from planting 

to harvest that includes early and final stand 

counts, vigor ratings, plant height, and number of 

ears and seed per plot

Source: (Monsanto, 2010)

References 

Monsanto (2010) Petition for the Determination of Nonregulated Status for MON 87460. 

Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See 

Table http://www.aphis.usda.gov/biotechnology/not_reg.html).