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

Determination of Non-regulated Status of Event MON 

87460 

OECD Unique Identifier: 

MON 87460-4 

Draft Environmental Assessment 

March 2011 

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services 

USDA, APHIS 

4700 River Road 

Riverdale, MD 20737 

Fax: (301) 734-8669 

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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

ACRONYMS 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: MON 87460 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 ..................................................................................... 3

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 .................................................................................. 10

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

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

2.2.2 Soil ........................................................................................................................ 12

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

2.2.4 Climate Change ..................................................................................................... 13

2.3 Animals and Plant Communities and Biodiversity ........................................................ 14

2.3.1 Animal Communities ............................................................................................ 14

2.3.2 Plant Communities ................................................................................................ 15

2.3.3 Biodiversity ........................................................................................................... 16

2.3.4 Gene Flow ............................................................................................................. 16

2.3.4.1 Intraspecies gene flow ..................................................................................................... 17

2.4 Human Health ................................................................................................................ 19

2.4.1 Public Health ......................................................................................................... 19

2.4.2 Worker Safety ....................................................................................................... 19

2.5 Livestock Health ............................................................................................................ 20

2.6 Socioeconomic ............................................................................................................... 20
iii 

2.6.1 Domestic and Trade Economic Environment ....................................................... 20

3 ALTERNATIVES................................................................................................................... 24

3.1 No Action Alternative: Continuation as a Regulated Article ........................................ 24

3.2 Preferred Alternative: Determination that MON 87460 CORN Is No Longer a 

Regulated Article, In Whole .......................................................................................... 24

3.3 Alternatives Considered But Rejected from Further Consideration .............................. 25

3.3.1 Prohibit Any MON 87460 from Being Released .................................................. 25

3.3.2 Deregulation in Part: Isolation Distance between MON 87460 and Non-GE Corn 

Production ............................................................................................................. 25

3.3.3 Deregulation in Part: Geographic Restrictions

...............................................................................................................................Er

ror! Bookmark not defined.

3.3.4 Requirement of Testing for MON 87460 .............................................................. 26

3.4 Comparison of Alternatives ........................................................................................... 27

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

4.3.1.3 Cumulative Effects: Current Acreage and U.S. Cultivation Range ................................ 34

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

4.3.2.3 Cumulative Effects: Cropping Practices ............................................................................ 37

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

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

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

4.3.3.3 Cumulative Effects: Organic ........................................................................................... 40

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

4.4.1.3 Cumulative Effects: Water Usage and Water Quality .................................................... 42

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

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

4.4.2.2 Preferred Alternative: Soil .............................................................................................. 43

4.4.2.3 Cumulative Effects: Soil ................................................................................................. 43

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

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

4.4.3.2 Preferred Alternative: Air Quality ................................................................................ 44

4.4.3.3 Cumulative Effects: Air Quality ..................................................................................... 44
iv 

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

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

4.4.4.2 Preferred Alternative: Climate Change ........................................................................... 45

4.4.4.3 Cumulative Effects: Climate Change .............................................................................. 45

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

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

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 ...................................................................... 48

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

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

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

4.5.3.3 Cumulative Effects: Animal and Plant Communities and Biodiversity ......................... 51

4.5.4 Gene Flow ............................................................................................................. 52

4.5.4.1 No Action Alternative: Gene Flow ................................................................................. 52

4.5.4.2 Preferred Alternative: Gene Flow ................................................................................... 52

4.5.4.3. Cumulative Effects: Gene Flow ........................................................................................ 53

4.6 Human Health ................................................................................................................ 53

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

4.6.1.1 No Action: Public Health ................................................................................................ 54

4.6.1.2 Preferred Alternative: Public Health ............................................................................... 54

4.6.1.3 Cumulative Effects: Public Health .................................................................................. 55

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

4.6.2.1 No Action: Worker Safety .............................................................................................. 56

4.6.2.2 Preferred Alternative: Worker Safety ............................................................................. 56

4.6.2.3 Cumulative Effects: Worker Safety ................................................................................ 56

4.7 Livestock Feed ............................................................................................................... 56

4.7.1 No Action: Livestock Feed ................................................................................... 56

4.7.2 Preferred Alternative: Livestock Feed .................................................................. 56

4.7.3 Cumulative Effects: Livestock Feed ..................................................................... 57

4.8 Socioeconomics .............................................................................................................. 57

4.8.1 Domestic Economic Environment ........................................................................ 57

4.8.1.1 No Action: Domestic Economic Environment ............................................................... 60

4.8.1.2 Preferred Alternative: Domestic Economic Environment ............................................. 60

4.8.1.3 Cumulative Effects: Domestic Economic Environment ................................................. 63

4.8.2 Trade Economic Environment .............................................................................. 64

4.8.2.1 No Action: Trade Economic Environment ..................................................................... 65

4.8.2.2 Preferred Alternative: Trade Economic Environment .................................................... 65

4.8.2.3 Cumulative Effects: Trade Economic Environment ....................................................... 65

4.9 International Impacts Analysis ....................................................................................... 66

4.9.1 Transboundary Impacts ......................................................................................... 66

5 THREATENED AND ENDANGERED SPECIES ................................................................ 67
v 

6 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS ................................................................ 71

6.1.1 Executive Orders with Domestic Implications ..................................................... 71

6.1.2 International Implications ..................................................................................... 76

6.1.3 Compliance with Clean Water Act and Clean Air Act ......................................... 77

6.1.4 Impacts on Unique Characteristics of Geographic Areas ..................................... 77

6.1.5 National Historic Preservation Act (NHPA) of 1966 as Amended ...................... 78

7 REFERENCES ....................................................................................................................... 79

8 LIST OF PREPARERS........................................................................................................... 88

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

000116) ................................................................................................................................... 91

Biotechnology Consultation - Note to the File Biotechnology Notification File BNF No. 

000119 ........................................................................................................................... 91

APPENDIX B. POLLEN- AND GENE-MEDIATED GENE FLOW ........................................ 97

B.1. Gene Flow among Corn Cultivars .................................................................................. 97

B.1.1 Pollen-mediated Gene Flow .................................................................................. 97

B.1.2 Seed-mediated Gene Flow .................................................................................... 100

APPENDIX C. CHARACTERISTICS MEASURED FOR PHENOTYPIC, AGRONOMIC, 

AND ENVIRONMENTAL INTERACTIONS ASSESSMENT OF MON 87460 .............. 102

   
vi 

List of Tables 

Table 1: Adoption of genetically engineered 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. ............................................................................................................... 11

Table 3: Relative importance of farms and corn in local economies. .......................................... 21

Table 4: Summary of potential impacts and consequences of Alternatives. ............................... 27

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

assumptions, long-term projections ............................................................................... 32

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

corn in select Great Plains states .................................................................................... 35

Table 7: Non-organic and organic corn production (harvested acres) in 2007 ....................... 38-39

Table 8: Minority populations in states where MON 87460 may be adopted, 2008 .............. 70-71

Table 9: Minority farmer populations in states where MON 87460 may be adopted, 2007 .................. 71

Table 10: Low income presence, 2008 ............................................................................................. 72

 
vii 

List of Figures 

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

Figure 2: Irrigated corn for grain, harvest acres: 2007 ................................................................ 21

Figure 3: Average values for U.S. corn harvest and average annual precipitation ...................... 31

Figure 4: Total, irrigated, and percent irrigated corn acreage in the western dryland 

Great Plains. ................................................................................................................. 33

Figure 5: Herbicide application trends in U.S. corn production, 2000-2005. .............................. 36
viii 

Acronyms 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 

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 

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 authorities 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) and 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: MON 87460 Drought Tolerant 

Corn 

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

determination of nonregulated status for Event MON 87460 drought tolerant (DT) corn 

(hereafter referred to as MON 87460) (Reeves, 2010). In the event of a determination of 

nonregulated status, the nonregulated status for MON 87460 would include MON 87460, and 

any progeny derived from crosses between MON 87460 and conventional corn and crosses of 

MON 87460 with other biotechnology-derived corn that has been deregulated pursuant to Part 

340 and the Plant Protection Act. Event MON 87460 is currently regulated under 7 CFR Part 

340. Interstate movements and field trials of MON 87460 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 (Reeves, 2010). 
3 

1.4 Purpose of Product 

MON 87460 is designed to mitigate grain yield loss under water-limited conditions. As detailed 

in the Monsanto Company petition, the enhanced drought tolerance of MON 87460 results from 

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

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

tolerant phenotype of MON 87460 manifests primarily as reduced yield loss relative to 

conventional corn when subjected to water-limiting conditions. When MON 87460 was 

subjected to well-watered conditions, grain yield for MON 87460 was not notably different than 

conventional corn. Data provided by the Monsanto Company demonstrates that MON 87460 

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 (Reeves, 2010). 

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

yield worldwide (Boyer, 1982; Bray et al., 2000). 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 MON 87460 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 the 

deregulation of MON 87460 corn. 

1.6 Coordinated Framework Review 

MON 87460 does not contain a biotechnology-derived PIP nor is it a biological control 

organism; thus, EPA does not regulate MON 87460.MON 87460 is within the scope of the FDA 

                                                            

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 

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 MON 87460, and submitted a safety and 

nutritional assessment of food and feed derived from MON 87460 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 MON 87460 drought tolerant corn 

(FDA, 2010). 

1.7 Public Involvement 

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

to petitions to deregulate 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 MON 87460. 

This EA, the petition submitted by the Monsanto Company (Reeves, 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 MON 

87460 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 draft 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, 

– Animals, 

– Plants, 

– Biological diversity, and 

– Gene movement. 
5 

 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: 2009

Source: (USDA-NASS 2010c). 
7 

The U.S. is the world's largest producer and exporter of corn. From 2008 through 2010, the U.S. 

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

the 2009/2010 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, 2011b). This 

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

will be driven by improvements in plant genetics, machinery, and cultivation practices (USDAERS, 2010e). Arable land for increased corn planting acreage will result from grower shifts 

away from soybean or wheat cultivation and from the return of Conservation Reserve Program 

(CRP) lands to agricultural production (USDA-ERS, 2011b). Representing a reduction from 

39.2 million acres to 32 million acres, this return of CRP land back into agricultural production 

has been stipulated by the Food, Conservation, and Energy Act of 2008 to provide additional 

cropland to meet future agricultural demands (Farm Bill, 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 genetically engineered (GE) varieties that have 

been deregulated by APHIS. 

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

genetic engineering systems (NCGA, 2010). Adoption of GE corn in the U.S. has significantly 

increased since 2000 on both the state and national level, with 86 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. 

 
8 

Table 1: Adoption of genetically engineered corn varieties by major U.S. corn production 

states, 2000-2010. 

GE Corn Varieties 

(percent of all corn planted) 

State 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 

Illinois 17 16 22 28 33 36 55 74 80 84 82 

Indiana 11 12 13 16 21 26 40 59 78 79 83 

Iowa 30 32 41 45 54 60 64 78 84 86 90 

Kansas 33 38 43 47 54 63 68 82 90 91 90 

Michigan 12 17 22 35 33 40 44 60 72 75 80 

Minnesota 37 36 44 53 63 66 73 86 88 88 92 

Missouri 28 32 34 42 49 55 59 62 70 77 79 

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

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

Ohio 9 11 9 9 13 18 26 41 66 67 71 

South Dakota 48 47 66 75 79 83 86 93 95 96 95 

Texas - - - - - 72 77 79 78 84 85 

Wisconsin 18 18 26 32 38 46 50 64 75 77 80 

Other States 17 20 27 36 46 44 55 67 74 78 82 

U.S. total 25 26 34 40 47 52 61 73 80 85 86 

Source: (USDA-ERS, 2010a)

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; 

Tanaka and Aase, 1987). 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). 

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; M. R. Hall et al., 1992; Howell et al., 1998; Levine, 1991; Smith and White, 

1988). 
9 

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

nitrogen, phosphorus, and potassium is widely practiced. 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) representing next the most widely-applied herbicide (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; Fernandez-Cornejo 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 

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

(Hoeft et al., 2000). Decisions about crop sequences are guided by many factors, including 

economic return from differences in input cost, yield potential, and commodity prices. Crops 

used in rotation with corn vary regionally, but there has been an increase in the number of fields 

that have a corn-to-corn rotation, as opposed to rotation to another crop other than corn. The 
10 

increased adoption of corn-to-corn rotation, mainly in conventional and GE production systems, 

has been attributed to rising corn demand and prices (Hart, 2006; Stockton et al., 2007). 

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, 2008). 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 

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 
11 

management. 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. In organic systems, the use of 

synthetic pesticides, fertilizers, and genetically engineered crops (e.g., MON 87460) is strictly 

limited or restricted. 

Organic certification involves oversight by an accredited 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. 

The unintentional presence of the products of excluded methods will not affect the status of an 

organic product or operation when the operation has not used excluded methods, and when the 

operation has taken reasonable steps to avoid excluded methods. However, retailers often 

require organic and non-GE farmers to verify their harvests through various tests (Ruth, 2003). 

In 2007 (the date of the last USDA Census of Agriculture), 93.5 million acres of corn were 

planted in the U.S., yielding 12.7 billion bushels of corn (USDA, 2009). 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 69 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. 

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 1,909 1,459 

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). 
12 

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 1 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. The primary cause of NPS pollution, 

however, is increased sedimentation following soil erosion. 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, facilitating higher water turbidity, algal blooms, and oxygen depletion in a body 

of water (EPA, 2005). 

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 suture, 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, 2010b; 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. 
13 

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, 2010c). 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, 

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

the form of methane and nitrous oxide (EPA, 2010b). 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). 

2.2.4 Climate Change 

Climate change represents a statistical change in climate conditions, and may be measured across 

both time and space. Production of agricultural commodities is interrelated with climate change 

on several different levels (Dale, 1997; Rosenzweig and Parry, 1994). U.S. agriculture may act 

as an affecter of climate change through various facets of the production process. Combustion of 

fossil fuels in mechanized farm equipment, fertilizer application, and decomposition of 

agricultural waste products may all contribute greenhouse gases to the atmosphere (Aneja et al., 

2009). Greenhouse gases collectively function as retainers of solar radiation, and agriculturerelated activities are recognized as both direct (e.g., exhaust from equipment) and indirect (e.g., 

agricultural-related soil disturbance) sources of CO2, methane (CH4), and N2O (EPA, 2010a). 

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, 2010a). Agricultural crop commodities may also affect dynamic geophysical 

soil processes, such as carbon turnover and sequestration, through tillage and cropping system 

practices. In general, reduced/conservation tillage practices favor more stable and increased 

carbon sequestration in the agro-environment (Lal, 2004). Additionally, climate change may 

also affect agricultural crop production. 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). 
14 

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, 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 approval. 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 Animals 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 rowcrop 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 (J. W. Smith, 2005). The thirteen-lined ground squirrel feeds primarily on seeds of 
15 

weeds and available crops, such as corn and wheat (J. Smith, 2005; Sterner, et al., 2003). 

Thirteen-lined 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 (H. G. 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 (H. G. Baker, 1965; Keeler, 1989). 

APHIS assessed whether MON 87460 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 MON 87460 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 
16 

cultivation (See Appendix C). Monsanto collected phenotypic and agronomic 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 complimentary data from four field 

trials from Chile (Reeves, 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 in tolerance 

enhanced weediness potential in MON 87460. 

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 

(Marshall et al., 2003; Pilcher et al., 2005; Ponsard et al., 2002). Alternatively, other studies of 

GE crops, such as Bt corn, when compared to non-GE crops sprayed with insecticides 

demonstrate that GE crops do not cause any changes in arthropod abundance or diversity (Chen 

et al., 2008; Romeis et al., 2006; Torres and Ruberson, 2005; N. Weber, 2009; Wolfenbarger et 

al., 2008). Some reports show that GE crops may even increase biological diversity in agroecosystems (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; Haughton et al., 2003; 

Hawes et al., 2003; Roy et al.; Wolfenbarger, et al., 2008). 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 both 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. 
17 

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

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

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

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

produced; and weather conditions, including temperature, wind, and humidity (Zapiola et al., 

2008). 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. In the U.S., 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 (Weber, 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. 

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

movement of genes between corn cultivars. These considerations apply separately to include 

both pollen-mediated gene flow as well as seed-mediated gene flow (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 (Zapiola, et al., 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; G. Kuepper, 2002; G Kuepper et 

al., 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). 
18 

Pollen-mediated gene flow and mitigation 

As noted, a primary spatial mechanism to maintain corn genetic purity is isolation distance. 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; W. E. 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. 
19 

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). Due to concurrent increases in corn 

production consumption and the increased adoption of GE corn, the general concern with GE 

corn is exposure through human and animal consumption. 

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). 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). 

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. 
20 

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 human consumption, there is a general concern regarding 

the impact of GE components on nutritional, allergenic, and toxicological aspects of the food 

produced by livestock. 

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, 

2011b). 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, 2011b). In the 2009/10 

marketing year, feed was approximately 40 percent of U.S. corn production, ethanol production 

was about 35 percent of U.S. corn use, food, seed, and industrial uses were approximately 45 

percent, and exports the remaining 15 percent (USDA-ERS, 2011b). 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 

California (USDA, 2009). Of these, all but California are in the Great Plains area of corn 

production. Figure 2 shows the corn acres harvested for grain in the U.S. that are irrigated 

(USDA-NASS, 2007b). 
21 

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: 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. 
22 

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 contamination 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, 

conventional corn averaged $4.19/bushel, whereas organic corn averaged $7.08/bushel (N. 

Weber, 2009). 

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, 2011b). 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, 2011b). 

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. 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, 2008b). South 

Korea has similar approval processes as Japan and requires labeling for GE animal feed (USDAFAS, 2008). 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). 

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. 
23 

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 deregulating DT Corn would be those countries who import DT 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. 
24 

3 ALTERNATIVES 

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of Monsanto Company MON 87460 corn. To respond favorably to a petition 

for nonregulated status, APHIS must determine that MON 87460 is unlikely to pose a plant pest 

risk. Based on its PPRA (USDA-APHIS, 2010) APHIS has concluded that MON 87460 is 

unlikely to pose a plant pest risk. Therefore APHIS must determine that MON 87460 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 MON 87460. 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. MON 87460 and progeny 

derived from MON 87460 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 MON 87460 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 

MON 87460. 

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

(USDA-APHIS, 2010) that MON 87460 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 MON 87460 CORN Is No Longer a 

Regulated Article 

Under this alternative, MON 87460 and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR Part 340. MON 87460 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 MON 87460 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 MON 87460 is unlikely to pose a plant pest risk, a determination of nonregulated status of 

MON 87460 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 MON 87460 and progeny derived from 

this event if the developer decides to commercialize MON 87460. 
25 

3.3 Alternatives Considered But Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for MON 87460. 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 MON 

87460. 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 MON 87460 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 MON 87460, including denying any 

permits associated with the field testing. APHIS determined that this alternative is not 

appropriate given that APHIS has concluded that MON 87460 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 MON 87460 is unlikely to pose a plant pest risk. 

Accordingly, there is no basis in science for prohibiting the release of MON 87460. 

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 MON 87460 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. 
26 

3.3.3 Isolation Distance between MON 87460 and Non-GE Corn Production and 

Geographical Restrictions 

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

considered requiring an isolation distance separating MON 87460 from conventional or 

specialty corn production. However, because APHIS has concluded that MON 87460 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 MON 87460 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 MON 87460 (USDAAPHIS, 2010). This alternative was rejected and not analyzed in detail because APHIS has 

concluded that MON 87460 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 rose 

productions systems from MON 87460 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 MON 87460 is available from Association of 

Official Seed Certifying Agencies (AOSCA 2004). 

3.3.4 Requirement of Testing for MON 87460 

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 MON 87460 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 MON 87460 would not meet APHIS’ purpose and need to 

respond appropriately to the petition in accordance with its regulatory authorities. 
27 

3.4 Comparison of Alternatives 

Table 4 presents a summary of the potential impacts associated with selection of either of the 

alternatives evaluated in this EA. The impact assessment is presented in Section 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 Movement 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
28 

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

of Nonregulated Status 

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 MON 87460 does not pose a plant pest risk. Potential 

environmental impacts from the No Action Alternative and the Preferred Alternative for MON 

87460 are described in detail throughout this section. A cumulative effects analysis is also 

included for each affected environment. 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 deregulating MON 87460 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, MON 87460 is unlikely to significantly increase 

future corn acreage beyond USDA-ERS projected expansion in irrigated U.S. corn production 

regions. The MON 87460 trait is intended to increase grain yield security under conditions of 

moderate water stress. Minimum moisture requirements are similar between MON 87360 and 

conventional corn and therefore MON 87360 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 MON 87460 

phenotype presented in the Monsanto 87460 Petition for Determination of Nonregulated Status. 

In summary, MON 87460 does not exhibit improved grain yield relative to the near-isogenic 

control corn variety when subject to well-watered conditions. When other indicators of MON 

87460 agronomic performance are compared to a variety of regionally-adapted corn reference 

hybrids and the near-isogenic control variety, MON 87460 neither significantly nor consistently 
30 

performs beyond the observed range of variation, further reinforcing the lack of increased 

agronomic performance in MON 87460 under well-watered conditions (Reeves, 2010). 

When subject to water-limited conditions (<50 percent field capacity), MON 87460 displays 

significantly less yield loss relative to the near-isogenic control corn variety. However, other 

measures of the MON 87460 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 MON 87460 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 MON 87460 under water-limited conditions confirms its 

single and predicted phenotype (Reeves, 2010). These data provide multiple lines of evidence 

indicating that the cspB trait plays a physiological role in modulating 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 (Plant Pest Risk 

Assessment (PPRA) for MON 87460 (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 86.5 million acres in 

2009/10 to 92 million acres in 2020/21(USDA-ERS, 2010b, 2011b). 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 86 percent in 2010 (USDA-ERS, 2010a). 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 market year September 2009 through August 2010, 86.4 million acres of corn were 

planted and approximately 134 million bushels of corn were harvested (USDA-ERS, 2010b). Of 

the total harvest, about 39 percent was used for animal feed and residuals, 35 percent was used 

for biofuels production, 10 percent was used for food and industrial purposes (not including 

alcohol for fuel), 0.17 percent was used as seed stock for hybrid seed production, 13 percent 

remained as ending stock seed, and 15 percent was exported for various uses in overseas markets 

(USDA-APHIS, 2010). 

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

Under the No Action Alternative, MON 87460 and its progeny would continue to be regulated 

articles under the regulations at 7 CFR part 340.. Independent of the No Action Alternative, both 

U.S. total corn acreage and the proportion of acreage planted with GE corn varieties is expected 

to incrementally increase through 2019, as indicated by USDA-ERS projections and previous 
31 

trends of GE corn adoption (USDA-ERS, 2011b). Increased demand for animal feed in the 

livestock industry, favorable net returns for corn ethanol production, and the readily available 

number of regionally-adapted corn hybrid varieties is likely to sustain this increase in domestic 

corn cultivation, with additional corn acreage planted primarily at the expense of other crops 

(e.g., wheat and soybean) (USDA-ERS, 2011b). Former CRP land returned into agricultural 

production may also provide land for additional corn acreage, though this contribution is likely 

to be minimal due to minimal projected net reduction in U.S. CRP acreage from 2011 to 2020 

(USDA-ERS, 2011b). 

Conventional corn production with GE varieties will continue to increase independently of a 

determination of non-regulated status of MON 87460, based on overall trends from previous 

years, and USDA-ERS modeling projections of corn production and demand. Market demand 

across all consumer sectors is anticipated to dictate overall increases in U.S. corn acreage. Corn 

will continue to be commercially cultivated in 49 U.S. states, with the majority of production 

centered in Midwestern U.S. Corn Belt states under the No Action Alternative. 

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

MON 87460 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 Plant Pest Risk Assessment of MON 87460 (Reeves, 2010; USDAAPHIS, 2010) the phenotype of MON 87460, with the exception of reduced yield loss under 

conditions of moderate drought stress, is similar to that of conventional corn. Like other 

domesticated corn varieties, MON 87460 does not exhibit traits that would allow it to establish 

outside the agricultural environment. Consequently, the cultivation range of MON 87460 is 

similar to that of conventional corn. A determination of nonregulated status of MON 87460 

under the Preferred Alternative will likely lead to cultivation in areas that already support 

economically viable corn production. 

In general, areas such as the Midwestern U.S. Corn Belt or any other region that receives 

sufficient precipitation (>30 inches) to routinely support high levels of corn production are 

unlikely to adopt MON 87460 due to a lack of improved agronomic performance under wellwatered conditions (Figure 3). These well-watered corn production regions generally do not 

require supplemental irrigation and represented 85 percent of total corn cultivation area in 2007. 

A determination of nonregulated status of MON 87460 is unlikely to lead to adoption and 

significantly expand corn acreage in these areas primarily due to the absence of grower benefit 

when subject to well-watered conditions. 
32 

Figure 3. Average values for U.S. corn harvest and average annual precipitation 

(1971-2000). 

Source: Data derived from the PRISM climate group database (http://www.prism.oregonstate.edu/) and USDA-NASS 

(USDA-NASS, 2007). 

When subject to water-limited conditions (<50 percent field capacity), MON 87460 displays 

significantly less yield loss while retaining similar measures of growth and developmental 

characteristics relative to conventional corn. Corn production regions subject to frequent 

moderate drought conditions may require supplemental irrigation, including the western dryland 

Great Plains and similar regions, and these represented 15 percent of all corn production regions 

in 2007. A determination of nonregulated status of MON 87460 under the Preferred Alternative 

is unlikely to significantly increase future corn acreage beyond USDA-ERS projected expansion 

in irrigated U.S. corn production regions. The MON 87460 trait is intended to increase grain 

yield security under conditions of moderate water stress. Minimum moisture requirements are 

similar between MON 87360 and conventional corn. When grown in water-limited field and 

greenhouse conditions, MON 87460 corn exhibits classic drought sensitivity symptoms, 

including reductions in yield, plant height, ear height, seedling vigor, and expected changes in 

plant height, chlorophyll content, and leaf roll (Reeves, 2010). The magnitude of these changes 

in MON 87460 under drought conditions is similar to that of water-limited conventional corn, 

with increasing water deficit producing increasingly severe growth and developmental 

symptoms. Taken in total, these data demonstrate that the negative effects of drought stress in 

MON 87460 are not alleviated and strongly suggest that areas unable to support economically 

viable production of conventional corn will also not support production of MON 87460, thus 

precluding the significant expansion of acreage in current irrigated corn production areas. 
33 

It is prudent to acknowledge, however, that the reduced yield phenotype of MON 87360 does not 

exceed the natural variation observed in regionally-adapted varieties of conventional corn 

(representing different genetic backgrounds) (Reeves, 2010). Thus, equally comparable varieties 

produced through conventional breeding techniques are readily available in irrigated corn 

production regions. Despite the availability of conventional drought tolerant corn varieties in 

these irrigated corn production regions, recent agronomic trends suggest that increases in corn 

acreage are often undertaken at the expense of other crops (e.g., wheat) on arable land or the 

return of former agricultural land (i.e., CRP land) into productivity, and not through cultivation 

of novel areas never managed for agricultural production now or in the foreseeable future (Table 

5). Additionally, irrigated corn acreage and percent irrigated corn acreage in the Great Plains 

region has been relatively stable, despite the availability of conventionally-produced drought 

tolerant corn varieties (Figure 4). The increase in corn acreage in 2007 was observed across the 

U.S. in general, and was not specific to the Great Plains dryland region (USDA-ERS, 2010b). 

This further suggests that MON 87460, with its reduced yield phenotype not exceeding that 

observed in conventionally-produced drought tolerant corn varieties, will not significantly alter 

present trends in irrigated corn acreage. 

Several reasons can be advanced for why corn acreage will not expand into areas not currently 

used for corn production. Existing drought tolerant varieties and conventional corn have similar 

moisture requirements and physiological responses to drought as do MON 87460. Also, adoption 

of MON 87460 is unlikely in the corn production in regions that are 85 percent well-watered and 

not requiring supplemental irrigation. Although conventionally-produced drought tolerant corn 

has been accessible to growers, there has been no associated expansion into novel areas in corn 

production regions. For these reasons, APHIS does not anticipate that a determination of 

nonregulated status of MON 87460 will significantly increase corn acreage beyond projected 

values nor alter current trends in crop production. 

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

assumptions, long-term projections (USDA-ERS, 2011b).

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 
34 

 

Figure 4. Total, irrigated, and percent irrigated corn acreage in the western 

dryland Great Plains. 

Values represent the average of irrigated acreage in Colorado, Kansas, Montana, Nebraska, New Mexico, 

North Dakota, Oklahoma, South Dakota, Texas, and Wyoming (USDA, 2009) 

4.3.1.3 Cumulative Effects: Current Acreage and U.S. Cultivation Range 

Cumulative effects of a determination of nonregulated status of MON 87460 are unlikely. 

Neither the No Action Alternative nor Preferred Alternative of a determination of nonregulated 

status of MON 87460 will directly cause an increase in agricultural acreage devoted to corn 

production beyond projected USDA-ERS increases. There are no anticipated changes to the 

availability of GE and non-GE corn varieties on the market under either alternative. The 

projected increase in corn acreage that occurs independently of MON 87460 will be sustained by 

both market demand for corn products and the large number of corn hybrid varieties that are 

readily available to growers. 

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, 

0

20

40

60

80

100

0

5000000

10000000

15000000

20000000

25000000

1992 1997 2002 2007

% irrigated

Corn acreage

Year

Total  acreage Irrigated acreage Percent irrigated acreage
35 

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. This same duration of stress during grain fill can 

cause a 40 to 50 percent yield reduction (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. 

4.3.2.1 No Action Alternative: Cropping Practices 

Under the No Action Alternative, MON 87460 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 

MON 87460 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). No-till 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 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 

and available technology strongly influencing corn rotation practices, under the No Action 

Alternative. 

4.3.2.2 Preferred Alternative: Cropping Practices 

Under the Preferred Alternative, a determination of nonregulated status of MON 87460 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 MON 87460 due to the low likelihood of adoption. 

A determination of nonregulated status of MON 87460 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. MON 87460 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 MON 
36 

87460 will significantly differ from conventional corn in responding to fertilizer or moisture 

application. In particular, MON 87460 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 MON 87460 and conventionallyproduced drought tolerant corn varieties will not differ. 

MON 87460 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 MON 87460 

event. Despite the absence of herbicide tolerant or insect resistant traits in MON 87460, 

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 glyphosate-tolerant corn, has not significantly affected corn acreage managed with 

total herbicide application (Figure 5). However, MON 87460 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 5). If MON 87460 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 MON 87460. Given typical corn 

offerings, corn hybrid varieties produced with MON 87460 will be highly likely to be stacked 

with other nonregulated pesticide traits since stacks of traits represent an increasing proportion of 

commercially-available corn varieties (Table 6). 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. 

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).
37 

Figure 5. 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) 

4.3.2.3 Cumulative Effects: Cropping Practices 

 A determination of nonregulated status of MON 87460 is not anticipated to have any cumulative 

effect on tillage, agricultural input practices, or rotation strategies related to U.S. corn 

production. MON 87460, with the exception of the phenotype of reduced yield loss under 

conditions of moderate drought stress, will not require significantly different crop production 

practices compared to other corn varieties. The requirements for crop rotation, tillage, and 

herbicide and pesticide use for both MON 87460 and any hybrid progeny produced from it will 

be exactly the same as those used for current corn varieties available to growers. 

4.3.3 Organic 

Certified organic corn represented 0.2 percent (194,637 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 National Organic Program (NOP) and 

administered by the USDA-AMS, must have distinct, defined boundaries and buffer zones 

between adjoining land not under 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 

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 

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 (Krueger, 2007; G Kuepper, et al., 2007; 

Riddle, 2004). Organic plans should also include mechanisms to monitor the risk of GE pollen or 

seed co-mingling with the organic crop (G 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 contamination 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, MON 87460 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 86 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 MON 87460 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 

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 
39 

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 MON 87460, 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 

Non-organic 

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 

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 
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 

Non-organic 

Organic Corn 

Production 

(acres harvested)**

Percent 

Organic 

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) 

4.3.3.3 Cumulative Effects: Organic 

Under both the No Action Alternative and the Preferred Alternative, a determination of nonregulated status of MON 87460 will not change market demands for corn produced through 

organic methods. A determination of nonregulated status of MON 87460 will add another GE 

corn variety to the conventional corn market. Conventionally produced corn (including GE corn) 

represents the vast majority of corn in states that produce organic corn, and a determination of 

nonregulated status of MON 87460 is not anticipated to significantly increase GE corn 
41 

production in these areas. Thus, presently-approved methods for the production of organic corn 

are sufficient to preserve certified organic status. Organic corn production will likely increase in 

spite of the surrounding conventional corn production whether or not MON 87460 is deregulated 

pursuant to Part 340 and the Plant Protection Act. 

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. MON 87460 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 MON 87460 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 MON 87460 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 MON 87460 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 MON 87460 is not enabled by increased water uptake, as demonstrated by several lines of 

evidence. Firstly, patterns of shoot and root fresh/dry weight between MON 87460 and 

conventional corn are not significantly different under well-watered or water-limited conditions 

(Reeves, 2010). If water uptake were increased in MON 87460, it is plausible that shoot/root 

fresh weight would be increased in MON 87460 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 MON 87460. The absence of increased water 

uptake is further validated by soil moisture depletion studies, where no significant differences in 
42 

soil moisture depletion rates were observed between MON 87460 and conventional corn 

(Reeves, 2010). Taken in total, the physiological evidence and recorded measures of moisture 

depletion strongly indicate that MON 87460 does not inherently transport more water than 

conventional corn. Consequently, MON 87460 is unlikely to directly and significantly impact 

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 MON 87460. 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. MON 

87460 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 MON 87460 is unlikely to cause changes in current water quality 

trends associated with corn production practices. 

4.4.1.3 Cumulative Effects: Water Usage and Water Quality 

A determination of nonregulated status of MON 87460 is not anticipated to have any cumulative 

effect on water use or quality in current corn production regions. Water use is not significantly 

different between MON 87460 and conventional corn. Additionally, water quality as the result 

of NPS pollution in corn production regions is unlikely to be significantly different between 

MON 87460, as no-tillage or reduced tillage strategies will continue to be available and utilized 

in corn production regions. 

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, APHIS would not deregulate MON 87460, and its use would 

be limited to areas APHIS has approved 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. 
43 

4.4.2.2 Preferred Alternative: Soil 

Under the Preferred Alternative, MON 87460 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 MON 87460, 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. 

Compositional analysis of MON 87460 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 MON 87460, the neomycin phosphotransferase II and cold shock 

protein B have been shown to be safe for the environment (Reeves, 2010). In particular, the 

NPTII protein has regularly been used in the selection of many transgenic crop varieties that 

have been deregulated pursuant to Part 340 and the Plant Protection Act, further demonstrating 

the safety of this protein. Because of the similarities in composition between MON 87460 and 

conventional corn, and the examined safety of the MON 87460 gene products, it is not 

anticipated that degradation of MON 87460 plant tissue following grain harvest will significantly 

impact microbial and arthropod soil populations compared to conventional corn. 

4.4.2.3 Cumulative Effects: Soil 

APHIS identified no impacts on the affected environment for soil as a result of the Proposed 

Action. Therefore, no cumulative effects on the affected environment for Soil were identified as 

a result of the Preferred Alternative. 

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 (J. B. Baker et al., 2005). 

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

carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides 

(EPA, 2010b). 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, MON 87460 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 
44 

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 MON 87460 and conventional corn. Thus, a determination of nonregulated status of 

Mon 87460 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 MON 87460 is similar to that of 

conventional corn, except under water-limiting conditions. When subject to water-limiting 

conditions, MON 87460 exhibits a reduced yield phenotype. Accordingly, the physical impact 

of MON 87460 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 

MON 87460 and conventional corn. 

4.4.3.3 Cumulative Effects: Air Quality 

APHIS has not identified any cumulative impacts for this issue. A determination of 

nonregulated status of MON 87460 is expected to on air quality due to similar cropping practices 

between MON 87460 or conventional corn. Both MON 87460 and conventional corn require 

intensive cropping practices for optimum grain yield, resulting in no cumulative impact on air 

quality related to those cropping practices. 

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, APHIS would not deregulate MON 87460, and its use would 

be limited to areas APHIS has approved for regulated releases. Agronomic management 

practices and phenotypic characteristics regarding MON 87460 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. 
45 

4.4.4.2 Preferred Alternative: Climate Change 

A determination of nonregulated status of MON 87460 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 MON 87460 and conventional corn. In particular, due to the 

continued availability of herbicide choice in MON 87460 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 MON 87460 is not significantly 

different from conventional corn, with the exception of reduced yield loss under water-limiting 

conditions. Accordingly, the physical impact of MON 87460 on climate change is not 

anticipated to be significantly different from that of conventional corn. 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 MON 87460 and conventional corn. 

4.4.4.3 Cumulative Effects: Climate Change 

APHIS has not identified any cumulative effects for this issue. Agronomic and phenotypic 

equivalence between MON 87460 and conventional corn, with the exception of reduced yield 

loss under water-limiting conditions, is not anticipated to significantly impact current corn 

production strategies, and thus, current agricultural impacts on climate change. 

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 below at “Cumulative Effects: Plants, 

Animals, Biodiversity.” 

4.5.1.1 No Action Alternative: Animal Communities 

Under the No Action Alternative, environmental releases of MON 87460 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 MON 87460 (Appendix A), 

which demonstrated a lack of toxicity and allergenicity of MON 87460 for human and animal 

consumption. Based upon the FDA consultation, APHIS supports Monsanto’s conclusions that 

MON 87460 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, MON 87460 would be deregulated. The agronomic practices 

used to produce MON 87460 are the same as those used to produce conventionally grown corn. 
46 

The introduced gene products of MON 87460 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 MON 87460 focuses solely on the nontarget impacts from MON 87460, especially 

the introduced proteins, CSPB and the NPTII marker protein. APHIS analyzed the potential 

impacts of MON 87460 on animal species including (1) exposure from directly contacting or 

consuming MON 87460, (2) exposure from increased use of pesticides or herbicides, and (3) 

conversion of CRP land to MON 87460 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 MON 87460 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 (Reeves, 2010). No differences 

between MON 87460 and non-drought-tolerant corn were noted except for the intended 

drought-tolerant 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 MON 87460 showed adverse consequences and that 

MON 87460 is not different in its environmental interactions relative to conventional corn. 

Because no differences in physical traits or characteristics were observed between MON 87460 

and conventional corn, it is not expected that MON 87460 would impact the behavior of 

arthropods found in or around corn fields.

MON 87460 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 MON 87460

and a control from several locations were evaluated for major nutrients and secondary 

metabolites (Reeves, 2010). The results indicate that MON 87460 is compositionally and 

nutritionally equivalent to conventional corn except for the expression of the transgene proteins 

(CSPB and NPTII). 

The transgene proteins in MON 87460 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). The petitioner assessed the risks to humans and 

animals from the transgene proteins present in the foods and feeds derived from MON 87460, 

and the results indicated no adverse effects, even at the highest tested dose levels (Reeves, 

2010). Furthermore, the CSPB protein represents no more than 0.00007 percent of the total 

protein in the grain of MON 87460, 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 MON 87460, 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 
47 

of MON 87460 (Appendix A), which demonstrated a lack of toxicity and allergenicity of MON 

87460 for human and animal consumption. 

Former CRP land returned into agricultural production may also provide land for additional corn 

acreage, although this contribution is likely to be minimal because of small net reduction in U.S. 

CRP acreage by 2020 (USDA-ERS, 2011b). In the event that farmers converted current CRP 

land to MON 87460 production, some birds and mammals that use CRP land for food and/or 

cover may be displaced to nearby areas of similar habitat. The animals that could be present 

in CRP areas would vary depending on the region and type of habitat. 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 bird species, such as grassland birds (e.g., grasshopper 

sparrows [Ammodramus savannarum], lark buntings [Calamospiza melanocorys], western 

meadowlarks [Sturnella neglecta], bobolinks [Dolichonyx oryzivorus]), ring-necked pheasants

(Phasianus colchicus), sage grouse (Centrocercus urophasianus), quail (family 

Odontophoridae), and waterfowl use CRP land (Ferris and Siikämaki, 2009). 

The introduced gene products of MON 87460 do not contain pesticidal activity and are not 

aimed at any target organisms as a control measure. As discussed in Cropping Practices Section 

(4.3.3.2 Preferred Alternative), MON 87460 does not contain any herbicide tolerant or insect 

resistant traits and adoption of MON 87460, either on its own or stacked with currently 

deregulated pesticide traits, is not anticipated to significantly change current corn agricultural 

practices. 

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 MON 

87460 (Appendix A). No major impacts on animals, either directly or indirectly, are expected 

from deregulating MON 87460; 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 plant species found in the U.S. The cumulative effects analysis for this 

issue is found below at “Cumulative Effects: Plants, Animals, Biodiversity.” 

4.5.2.1 No Action Alternative: Plant Communities 

Under the No Action Alternative, environmental releases of MON 87460 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. 
48 

4.5.2.2 Preferred Alternative: Plant Communities 

MON 87460 is not expected to become more invasive in natural environments, compete with 

native vegetation, or have any different effect on habitat than conventional corn (USDAAPHIS, 2010). Corn struggles to survive without human assistance and does not possess traits 

that are characteristic of successful weeds (H. G. Baker, 1965; Galinat, 1988; Keeler, 1989). 

Like many domesticated crops, corn seed from a previous year’s crop can lie dormant over 

winter and 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 MON 87460 

For the majority of the agronomic traits assessed, there were no statistically significant 

differences between MON 87460 and nontransgenic control (Reeves, 2010). No biologically 

meaningful differences were detected in the germination and dormancy of seed from MON 

87460. In particular, the absence of hard seed supports a conclusion of no increased weediness 

potential of MON 87460 compared to conventional corn for germination and dormancy 

characteristics (Reeves, 2010). No differences were detected in pollen morphology or viability 

between MON 87460 and the control (Reeves, 2010). Results from the genotype-environmental 

interaction assessments also support the conclusion that MON 87460 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). Finally, MON 87460 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 MON 87460 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 MON 87460 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 MON 87460 if Hybridized with Other Plants 

MON 87460 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 MON 87460

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, 
49 

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). MON 87460 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 (Doebley, 1990a, 1990b; Ellstrand et al., 2007; Galinat, 1988). 

Tripsacum dactyloides and Tripsacum floridanum would not be affected by MON 87460

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, MON 87460 would pose no direct or 

indirect impacts on sexually compatible wild relatives.

Other Possible Impacts 

The introduced gene products of MON 87460 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), MON 87460 does not contain any herbicide tolerant or insect resistant 

traits and adoption of MON 87460, either on its own or stacked with currently deregulated 

pesticide traits, is not anticipated to change current corn agricultural practices. 

Minor impacts on plant populations could occur if farmers converted current CRP land to MON 

87460 production. The extent of impacts depends on the amount of CRP land converted to 

agriculture. However, the USDA (USDA-ERS, 2011b) sees no increase 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 

deregulating MON 87460; 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 by certain animal 

pests. 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 agroecosystem 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 
50 

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). 

4.5.3.1 No Action Alternative: Biodiversity 

Under the No Action Alternative, environmental releases of MON 87460 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 MON 

87460 would not convert CRP land to MON 87460 production. It is not expected that use of 

MON 87460 in existing corn field would result in any changes in herbicide or pesticide 

application. Cultivation of MON 87460 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 MON 87460 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) MON 87460 would replace another crop; 2) land would be converted from 

inactive cropland to active cropland using MON 87460; 3) planting MON 87460 would require 

an increase in pesticide or herbicide use; or 4) CRP lands would be converted to MON 87460 

production, the impact to biodiversity would be considered minor based on the following 

discussion. 

The replacement of a different crop (such as soybeans) to MON 87460 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 

MON 87460 would not be likely to affect the overall species richness or abundance. 

If farmers substituted organic corn cultivation with MON 87460 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 
51 

landscapes, but not in small-scale landscapes comprised of many other habitat types (Bengtsson 

et al., 2005). 

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 MON 

87460 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 MON 87460 production. As 

noted earlier, if all converted CRP land were used to grow corn, the impacts would represent 

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 2011; 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). 

4.5.3.3 Cumulative Effects: Animal and Plant Communities and Biodiversity 

No direct or indirect impacts of MON 87460 on plants were determined because MON 87460 

does not possess weedy characteristics, and is unlikely to introgress into wild plants or to corn 

agriculture. Consequently, no cumulative impacts would be expected. 

There may be some potential for certain foreseeable actions to contribute to cumulative impacts 

in conjunction with adoption of MON 87460. One action could include industry stacking 

together multiple drought tolerant corn varieties with additional traits such as insect resistance, 

and herbicide tolerance. Non-regulated GE traits may be stacked with MON 87460 would also 

have been evaluated by USDA, EPA and FDA, and will be as safe as the non-transgenic corn 

varieties. Continued conversion of inactive cropland and CRP lands to croplands that could be 

planted to MON 87460 may lead to a decrease in biodiversity (because of increased used of 

herbicides, pesticides and the general effects of agriculture) and displacement of plants and 

animals. However, as shown previously, USDA does not expect large scale conversion of CRP 

acres to corn production. In CRP land that is converted to corn acreage, adoption of MON 

87460 would not result in any cumulative impact on animal and plant communities because corn 

cropping practices, including pesticide application, is not anticipated to be significantly different 

from conventional corn. 

If MON 87460 corn were grown without additional traits, different herbicides would be used 

than those typically used in herbicide-tolerant crops, but as demonstrated in the Preferred 

Alternative analysis under Cropping Practices, no change to total pesticide application area of 

corn would be expected, though shifts in pesticide product use may occur. However, also as 

discussed in Cropping Practices Section (4.3.2.2 Preferred Alternative), any shift of specific 

pesticide product use would likely be mitigated by hybridization of MON 87460 with other 

deregulated herbicide-tolerant or insecticide traits that are likely to be already present in the area. 
52 

4.5.4 Gene Flow 

4.5.4.1 No Action Alternative: Gene Flow 

Under the No Action Alternative, environmental releases of MON 87460 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 MON 87460 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, MON 

87460 does not notably differ from other corn varieties. Under well-watered conditions, MON 

87460 did not notably differ from non-GE comparable varieties (Reeves, 2010). No evidence of 

changes to pollen attributes or seed attributes were observed (Reeves, 2010). Gene flow 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 MON 87460 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. 

Based on the information detailed in the sections above, pollen-mediated gene flow between corn 

crop fields planted with MON 87460 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 MON 87460 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 MON 87460, 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 MON 87460. Because MON 87460 exhibits 

decreased yield loss under water-limiting conditions (Reeves, 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 MON 87460 under water-limiting conditions 

(Reeves, 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 (R. C. Hall and Twidwell, 2002). Therefore, pollen-mediated gene flow from 

MON 87460 under drought conditions would not be expected to differ from conventional corn 
53 

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 

MON 87460 (Reeves, 2010), the expression of the cspB conveys a drought resistance trait that 

decreases yield loss when subject to reduced water conditions. If MON 87460 seeds were able 

to successfully disperse out of crop fields by natural mechanisms (e.g., extreme weather) or 

human-mediated mechanisms (e.g., transport), persistence of the corn could not be expected to 

produce a feral population because the shatter and dispersal attributes of MON 87460 are not 

reported to be different from conventional corn. The only phenotypic difference between MON 

87460 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. 

4.5.4.3. Cumulative Effects: Gene Flow 

MON 87460 is not likely to increase the impact of gene flow to an extent greater than that of 

other corn varieties and would also not likely do so when combined with other GE traits that 

have themselves been evaluated as having no traits that would increase potential gene flow. 

Additionally, no deregulated GE variety of corn has resulted in a change in the properties 

associated with pollen-mediated or seed-mediated gene flow from corn. Therefore, there are no 

expected cumulative impacts. 

4.6 Human Health 

This section focuses on whether the proposed action affects overall public health and worker 

safety. For MON 87460, 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 MON 87460 

center on food and product safety, including 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 MON 87460 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 MON 87460 

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 MON 87460 and 

provided a comprehensive assessment of food and feed safety data on the CSPB and NPTII 

proteins in MON 87460. The FDA has determined Monsanto’s submission to be complete (FDA, 
54 

2010). MON 87460 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: Public Health 

Under the No Action Alternative, MON 87460 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 

MON 87460 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 MON 87460. 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 (Reeves, 2010), the CSPB and NPTII proteins are anticipated to present no 

potential adverse effects to exposed organisms, including humans, in the environment. The 

following paragraphs summarize the supporting information from the safety assessment 

performed for CSPB and NPTII proteins found in MON 87460. 

Acute oral toxicity studies for the CSPB and NPTII 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 MON 87460. 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. 

Based on assessments performed with bioinformatic tools, such as the FASTA algorithm and the 

PROTEIN and TOXIN6 databases, CSPB and NPTII 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). 

The donor organism of the CSPB protein, B. subtilis, has been shown to be not 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, 1999b). 

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. 
55 

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 MON 87460. 

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 deregulated by APHIS BRS; 

http://www.isb.vt.edu/cfdocs/biopetitions1.cfm), including corn. 

Compositional comparisons between MON 87460 and conventional corn presented by Monsanto 

showed no biologically meaningful differences for grain and forage compositions either for 

major nutrients or for secondary metabolites (Reeves, 2010). Therefore, based on this data, it is 

reasonable to assume that the foods and feeds derived from MON 87460 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 MON 87460, APHIS 

has concluded that under the Preferred Alternative, a determination of nonregulated status of 

MON 87460 would have no expected impacts on public health. 

4.6.1.3 Cumulative Effects: Public Health 

There are no expected impacts on human health related to the Preferred Alternative. APHIS has 

determined that there are no past, present, or reasonably foreseeable actions that would aggregate 

with effects of the proposed action to affect public health. Therefore, there are no cumulative 

effects identified for this issue. 

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 
56 

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: 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 MON 87460 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 MON 87460 would remain the same 

as those under the No Action Alternative. 

4.6.2.3 Cumulative Effects: Worker Safety 

Worker safety issues related to agronomic practices and the use of pesticides during agricultural 

production of MON 87460 would remain the same under both alternatives. APHIS has 

determined that there are no past, present, or reasonably foreseeable actions that would aggregate 

with effects of the proposed action to impact worker health and safety. Therefore, there are no 

cumulative effects identified for this issue. 

4.7 Livestock Feed 

As with human health, livestock ingestion of inserted genes and proteins in MON 87460, with 

subsequent human ingestion of livestock food products, is considered one of the primary 

concerns in MON 87460. In addition, horizontal transfer of genetic material to gastrointestinal 

bacteria is a concern. This section addresses the use of MON 87460 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: Livestock Feed 

Under the No Action Alternative, APHIS would not deregulate MON 87460, and its use would 

continue to be limited to areas APHIS has approved for regulated releases. Thus, there would be 

no additional risks or benefits to livestock feed safety from MON 87460. 

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 MON 87460 indicated that they are not 

expected to be allergenic, toxic, or pathogenic in mammals. Additionally, no gene transfer to 

gastrointestinal flora is expected. Both CSBP and NPII proteins have a history of safe 

consumption in the context of other food and feeds (FDA, 2010). 
57 

Compositional analyses of forage and grain tissues from MON 87460 confirmed that the corn 

grain and forage derived from MON 87460, and the intended foods and feeds derived from MON 

87460, 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 MON 87460 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 MON 87460 will be low, with chickens, swine, and 

dairy cows consuming only nanogram quantities of each protein per kilogram of body weight 

(Reeves, 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 (http://vm.cfsan.fda.gov/~dms/opa-armg.html). 

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. 

4.7.3 Cumulative Effects: Livestock Feed 

There are no expected impacts on human or livestock health related to the Preferred Alternative. 

APHIS has determined that there are no past, present, or reasonably foreseeable actions that 

would aggregate with effects of the proposed action to affect livestock feed. Therefore, there are 

no cumulative effects identified for this issue. 

4.8 Socioeconomics 

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, 

2011b). 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, 2011b). In the 2009/10 

marketing year, feed was approximately 40 percent of U.S. corn production, ethanol production 

was about 35 percent of U.S. corn use, food, seed, and industrial uses were approximately 45 

percent, and exports the remaining 15 percent (USDA-ERS, 2011b). 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). 
58 

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, 

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, 

2011b). 

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 MON 87460 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 MON 

87460 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 MON 87460, 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 MON 87460 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 MON 87460 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 
59 

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 MON 87460 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 

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 MON 87460 would be more 

likely in some geographic areas than in others. Therefore, the domestic economic environment 

most likely affected by deregulating MON 87460 would be the area of its adoption. To the 

extent MON 87460 adoption allows for increased returns from corn production, MON 87460 

deregulation could increase the supply of corn and corn-related farm income. 

Because MON 87460 is expected to decrease yield loss in water-limited conditions, deregulation 

of MON 87460 could impact total domestic corn production and corn acreage. Because it is a 

GE crop, the potential for unintended presence in non-GE corn fields could impact marketing 

non-GE and organic corn.
60 

4.8.1.1 No Action: 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 MON 87460 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 

Deregulating MON 87460 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 (Reeves, 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 MON 87460. 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) 

(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) (PioneerHi-Bred, 2010, 2011a, 2011b). The impacts of deregulating MON 87460 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 MON 87460 during water-limited 

conditions, the impact of yields on returns, the elasticity of corn acreage to increased returns, and 

the extent of adoption of MON 87460. 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 (Reeves, 

2010) (i.e., yield under water-limited conditions would be 85% of the yield under 

adequate water conditions). 

2. MON 87460 is expected to provide a 6 percent reduction in yield losses under those 

circumstances (Reeves, 2010). 
61 

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 

 = 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 MON 87460 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 MON 87460 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 MON 87460 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 
62 

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 

farms potentially benefiting from MON 87460 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 MON 87460 deregulation on corn acreage is 

expected to be minor. 

Locations of Increased Farm Income 

Corn-related farm incomes could increase in areas that adopt MON 87460. 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 offfarm 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 the deregulation of MON 87460 are expected to be 

negligible. 

Impacts on Irrigation and Water Use with MON 87460 

Regarding the impact of MON 87460 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 MON 87460. Indeed, the observations presented in the petition indicate that 

expected maximum yield in the variety depends on attaining sufficient water (Reeves, 2010). 

MON 87460 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 proven possible or 

that MON87460 was otherwise useful in some circumstances to reduce use of irrigation water. 

At present, irrigation sparing capacity of MON 87460 has not been demonstrated, and 

expectations for savings on irrigation are not consistent with current experimental observations 

provided by the applicant (Reeves, 2010). 
63 

Additional Impacts 

The greatest impact of the product will likely be that growers experience yield losses with MON 

87460 that are less than those incurred by planting non-drought tolerant corn varieties. Another 

possible impact is the possible reduction of crop insurance costs, since better potential yield in 

drought could be purchased by growers especially if growing MON 87460 might be specifically 

stipulated by an insurance contract (as for example, a “Biotech Yield Endorsement” that is 

offered by insurance providers (Iowa State, 2007)). An increase in land values as a result of 

planting MON 87460 is also possible, although there is not enough information to assess these 

potential impacts. 

Impacts on Organic and non-GE Corn Producers by MON 87460 

Non-GE, organic, and GE corn are currently grown in generally the same areas. Although the 

unintended presence of GE content in organic farming does not necessarily lead to the loss of 

organic certification, a cost to both organic and non-GE corn farmers may include testing for the 

presence of GE material that is required by some discriminating buyers. However, there is no 

reason to believe that gene flow from MON 87460 would be any more likely than gene flow 

from currently available GE varieties for reasons previously described. To the extent 

deregulation of MON 87460 would contribute to increased GE corn acreage, the likelihood of 

proximity of organic and non-GE corn farmers to GE corn 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 MON 87460 deregulation on corn acreage 

could be substantially less than that of other current factors that encourage planting of other GE 

varieties and for them to affect increases in corn acreage. 

An estimate of the increase in corn production would depend on the degree of adoption, on the 

actual impact of MON 87460 to yields under water-limited conditions, and the degree of water 

shortage in any given year. The overall impact of MON 87460 deregulation on U.S. corn 

production is expected to be minor. 

4.8.1.3 Cumulative Effects: 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 MON 87460 deregulation. 

Corn acreage is expected to increase, but conversion of CRP acreage to new corn acres is not 

expected to increase. The 2008 Farm Bill reduced the maximum acreage allowed in the CRP to 

32 million, 2.6 million acres below the 2008 enrollment (Farm Bill, 2008). To the extent that 

some of this land is converted to agricultural use, existing corn acreage could increase and add to 

the incentive for corn production. The conversion of CRP acres would be independent of 

adoption of MON 87460 corn. 

Other Federal policies such as Federal crop insurance, marketing loans, direct and countercyclical payments, and the Average Crop Revenue Election (ACRE) program may influence 
64 

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 MON 87460 deregulation. 

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 deregulating of MON 87460. 

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, 2011b). 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, 2011b). 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, 2008b). South Korea has similar approval processes as Japan and requires labeling for GE 

animal feed (USDA-FAS, 2008). 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). 

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, 2011a; 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 
65 

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 

deregulating MON 87460 would be those countries who import MON 87460 feed, seed, and 

food. 

4.8.2.1 No Action: Trade Economic Environment 

The USDA provides projections for the agricultural sector through 2020 (USDA-ERS, 2011b). 

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 deregulation 

of MON 87460 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 MON 87460 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 MON 87460 in primary U.S. export 

destinations with functioning regulatory systems before commercialization in the U.S. (Reeves, 

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. 

MON 87460 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. 

MON 87460 seed as a result of the deregulation of MON 87460, 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. 

4.8.2.3 Cumulative Effects: 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. MON 87460 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. MON 87460 could have impacts of unknown size on U.S. trade following MON 

87460 deregulation in the U.S and abroad. Currently, requests for approvals for all purposes 
66 

including planting have been submitted to Mexico and Canada but only Canada has approved the 

product for cultivation so far. 

4.9 International Impacts Analysis 

4.9.1 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 MON 87460 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). 

MON 87460 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 (Doebley, 1990a, 1990b; Ellstrand, et al., 2007; Galinat, 1988). Further, 

Tripsacum dactyloides and Tripsacum floridanum would not be affected by MON 87460 

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 the deregulation of MON 87460. 
67 

5 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; 
68 

 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 MON 87460 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 MON 87460. Indirect effects are those that 

could result from the use of MON 87460 in corn production, would occur later in time, but are 

still reasonably certain to occur. Consideration is given for the potential of MON 87460 to 

change the baseline habitat of TES including critical habitat. 

MON 87460 will be grown on agricultural acres managed by growers in a manner similar to 

conventionally bred corn. MON 87460 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 MON 87460 on TES plants. 

Because corn cannot naturalize and would not affect pollinators, there are no expected 

indirect effects of MON 87460 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 MON 87460. Therefore, it is highly unlikely that 

MON 87460 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 MON 87460 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 MON 87460. Because there is 

no toxicity or allergenicity potential with MON 87460, 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 MON 87460 (Appendix A), which demonstrated a lack of toxicity and 
69 

allergenicity of MON 87460 for human and animal consumption. Therefore, it is unlikely that 

MON 87460 would affect threatened and endangered animal species, including animals such 

as insects, bats or birds that may be pollinators of TES plants. 

APHIS has considered whether approval of MON 87460 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; McCoy et al., 2001). Animals, including threatened 

and endangered species that could be affected by conversion of CRP land to MON 87460

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. 

MON 87460 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 MON 87460 corn have been shown to be different from commodity corn, it is highly unlikely 

that MON 87460 will have impacts different from other commodity corn varieties. Neither are 

impacts likely when MON 87460 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 MON 87460 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 MON 87460 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 the deregulation of this MON 87460 

corn is unlikely to lead to large scale conversion of CRP land and consequent significant 

impacts on some CRP land that could become agricultural. 
70 

Based on the above information, APHIS has concluded that a determination of nonregulated 

status of MON 87460 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. 
71 

6 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS 

6.1.1 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 minority presence in the U.S. and in the states where MON 87460 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 MON 87460 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% 

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% 
72 

Table 8. Minority populations in states where MON 87460 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

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 MON 87460 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) 

To the extent that impacts of MON 87460 deregulation 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 
73 

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 

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 
74 

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. 

MON 87460 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 MON 87460 

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 MON 87460 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 deregulation of 

MON 87460 are expected to have a disproportionate adverse effect on minorities and low 

income populations. MON 87460 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 MON 87460, corn hybrid varieties may be produced with MON 

87460 and other nonregulated corn hybrids containing herbicide tolerant and/or pesticide traits. 

Thus, pesticide application practices and usage associated with deregulation of MON 87460 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 

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. 
75 

MON 87460 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 MON 87460 

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 MON 87460 and its products to humans, including 

children 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 deregulation of 

MON 87460 are expected to have a disproportionate adverse effect on children. MON 87460 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 MON 87460, 

corn hybrid varieties may be produced with MON 87460 and other nonregulated corn hybrids 

containing herbicide tolerant and/or pesticide traits. Thus, pesticide application practices and 

usage associated with deregulation of MON 87460 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 MON 87460, 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 MON 87460 compared with other GE corn or non-GE corn, apart from the presence of 

the CSPB and NPTII proteins. MON 87460 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 MON 87460. Based on APHIS’ assessment of MON 87460, it is unlikely that a

determination of nonregulated status of MON 87460 will have a negative effect on migratory bird 

populations. 
76 

6.1.2 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 MON 87460. 

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 MON 87460 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. 
77 

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. 

6.1.3 Compliance with Clean Water Act and Clean Air Act 

This EA evaluated the changes in corn production due to the unrestricted use of MON 87460. 

Cultivation of MON 87460 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 MON 87460 

compared with current corn production. Also, there is no expected change in air quality 

associated with the cultivation of MON 87460. 

Based on this review, APHIS concludes that the cultivation of MON 87460 would comply with 

the Clean Water Act and the Clean Air Act.

6.1.4 Impacts on Unique Characteristics of Geographic Areas 

A determination of nonregulated status of MON 87460 is not expected to impact unique 

characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and 

scenic areas, or ecologically critical areas. 

The common agricultural practices that would be carried out in the cultivation of MON 87460 

are not expected to deviate from current practices. The product is expected to be deployed on 

agricultural land currently suitable for production of corn and replace existing varieties, and is 

not expected to increase the acreage of corn production. 

There are no proposed major ground disturbances; no new physical destruction or damage to 

property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease, 

or transfer of ownership of any property. This action is limited to a determination of 
78 

nonregulated status of MON 87460. This action would not convert land use to nonagricultural 

use and therefore would have no adverse impact on prime farm land. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used on 

agricultural lands planted to MON 87460, including the use of EPA registered pesticides. 

6.1.5 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 MON 87460 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. 

APHIS’ Preferred Alternative would have no impact on districts, sites, highways, structures, or 

objects listed in or eligible for listing in the National Register of Historic Places, nor would it 

likely cause any loss or destruction of significant scientific, cultural, or historical resources. 

APHIS’ proposed action is not an undertaking that may directly or indirectly cause alteration in 

the character or use of historic properties protected under the NHPA. In general, common 

agricultural activities conducted under this action do not have the potential to introduce visual, 

atmospheric, or noise elements to areas in which they are used that could result in effects on the 

character or use of historic properties. For example, there is potential for increased noise on the 

use and enjoyment of a historic property during the operation of tractors and other mechanical 

equipment close to such sites. Nevertheless, it is expected that this noise would only be 

temporary and short-term. The cultivation of MON 87460 is not expected to change any of these 

agronomic practices that would result in an adverse impact under the NHPA.

 
79 

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88 

8 LIST OF PREPARERS 

Biotechnology Regulatory Services 

David Reinhold 

Assistant Director, Environmental 

Risk Analysis Program 

Kham Vongpaseuth, 

APHIS Fellow 

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 

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 
89 

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 

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 
90 

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 

   
91 

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 waterlimited 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 water-limited 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. 

Transformation Plasmid and Method 

Monsanto described the development of corn event MON 87460 using Agrobacterium tumefaciensmediated 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 
92 

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 wellwatered (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 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 
93 

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. coliproduced 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. 

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 
94 

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 non-transgenic 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 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), anti-nutrients (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 

split-plot 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. 
95 

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 water-limited 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 combined-site 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 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 watersupplemented 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. 
96 

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 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 (MON-8746Ø-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 
97 

APPENDIX B. POLLEN- AND GENE-MEDIATED GENE FLOW 

B.1. Gene Flow among Corn Cultivars 

As reviewed by Zapiola and Mallory-Smith (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 Zapiola and Mallory-Smith 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 

can be an effective barrier to gene exchange between corn crop cultivars (Zapiola and Mallory-
98 

Smith 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 

(Zapiola and Mallory-Smith 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. 
99 

 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]) (Sanvido et al. 2008, Ireland et al. 2006), 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, Louette 1996). 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 
100 

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 2001). 

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 (Zapiola and Mallory-Smith 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 (Zapiola 

and Mallory-Smith 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 
101 

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. Therefore, corn is not suited to survive without human management 

and is not typically described as a weed (Baker 1965, Keeler 1989, Galinat 1988). Corn 

is not present as a noxious weed on federal lists ((USDA-APHIS 2010, Crockett 1977,

Holm et al. 1979, Muenscher 1980) 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 (see Zapiola and Mallory-Smith 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. 
102 

APPENDIX C. CHARACTERISTICS MEASURED FOR PHENOTYPIC, 

AGRONOMIC, AND ENVIRONMENTAL 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

Yield (bu/ac) Harvest Harvested weight of shelled grain, adjusted to 

15.5% moisture
103 

Characteristic 

Characteristic 

Measured 

Evaluation 

Timing 

Evaluation Description (measurement 

endpoints 

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: (Reeves, 2010)