# 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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Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agricultur e over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentione d. 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 agenci es 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 Nonregulat ed Status: MON 87460 Drought Tolerant Corn

.............................................................................................................................. ........... 2

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

1.5 APHIS Response to Petition fo r 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 ........................................................................................................................ 1 2

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 ................................................................................................................ 1 9

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

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

2.5 Livestock Health ............................................................................................................ 2 0

2.6 Socioeconomic ............................................................................................................... 2 0iii 

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

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

3.1 No Action Alternative: Continua tion 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 Reject ed from Further Consideration .............................. 25

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

3.3.2 Deregulation in Part: Isolation Dist ance 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 Acr eage and U.S. Cultivation Range ........................... 30

4.3.1.2 Preferred Alternative: Current Acr eage 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 U sage and Water Quality .................................................... 42



### 4.4.2 Soil ........................................................................................................................ 4 2

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 ..................................................................................... 44iv 

### 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 ................................................................................................................ 5 3

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 .............................................................................................................. 5 7

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

4.8.1.1 No Action: Domestic Ec onomic 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: Trad e 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 ENDA NGERED SPECIES ................................................................ 67v 

### 6 CONSIDERATION OF EXECUTIVE OR DERS, 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 BIO TECHNOLOGY CONSULTATION NOTE TO THE FILE (BNF NO. 000116) ....................................................................................................................... ............ 91

Biotechnology Consultation - Note to the Fi le Biotechnology Notifi cation 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 .............. 102vi 

## 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 fa rms 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 herbic ide-tolerant, insect-resistant, stacked trait, and total GE

corn in select Great Plains states .................................................................................... 35 Table 7: Non-organic and organic corn production (har vested 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 

### ............................................................................................. 72vii 

## List of Figures

Figure 1: Corn, plant acres: 2009 ............................................................................................ ....... 6 Figure 2: Irrigated corn fo r grain, harvest acres: 2007 ................................................................ 21 Figure 3: Average values for U.S. corn harvest and average a nnual precipitation ...................... 31 Figure 4: Total, irrigated, and percent ir rigated corn acreage in the western dryland

Great Plains. ................................................................................................................. 33 Figure 5: Herbicide app lication trends in U.S. corn production, 2000-2005. .............................. 36viii 

## Acronyms and Abbreviations

AIA Advanced informed agreement

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BRS Biotechnology Regulatory Serv ices (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)

CH 4 

### methane

CO carbon monoxide

CO 2 

### 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 organismix 

### 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

NO 2 

### nitrogen dioxide

N 2 

### O 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 Agricultur e-Economic Research Service

USDA-FAS U.S. Department of Agricultur e-Foreign Agricu ltural Service

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

USDA-NOP U.S. Department of Agricult ure-National Organic Program

USC United States Code

WPS Worker Protection Standard for Agricultural Pesticides1 

### 1 PURPOSE AND NEED

1.1 Regulatory Authority

"Protecting American agriculture" is the basic charge of the United St ates 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, an d contributes to the national economy and the public health. USDA asserts that all met hods 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 regulat ed 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 Scie nce and Technology Po licy, describes the comprehensive federal regulatory policy for ensu ring the safety of biotechnology research and products and explains how federal agencies will use existing Federal st atutes in a manner to ensure public health and environmental safety wh ile maintaining regulatory flexibility to avoid impeding the growth of the bi otechnology industry. The Coordi nated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their re spective statutory authorities; (2) agencies are required to focus on the characteri stics and risks of the biotechnol ogy 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 explai ns 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 Administra tion (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 aut hority 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 genetica lly 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 c onsultation process. Al l food and feed derived from GE crops currently on the market in the Un ited States have successfully completed this consultation process. The FDA policy statemen t 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 a nd animal feed safety is sues or other regulatory issues (e.g., labeling) are resolv ed prior to commercial dist ribution of bioengineered food.2 

### The EPA regulates plant-incorpor ated protectants under the Federa l 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 a nd 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 Unit ed 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 longe r subject to the plant pest provisions of the Plant Protection Act or to the regulatory re quirements 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, reci pient organism, vector, or vector agent used in engineering the organism belongs to one of the ta xa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated un der 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 regula ted under the plant pest provisions of the Plant Protection Act or the regulatio ns 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 unl ikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requireme nts of 7 CFR part 340 or the plant pest provisi ons of the Plant Protection Act when AP HIS determines that it is unlikely to pose a plant pest risk.

1.3 Petition for Determination of Nonregul ated 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 nonre gulated status for MON 8746 0 would include MON 87460, and any progeny derived from crosses between MO N 87460 and conventional co rn 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 acknowle dged by APHIS since 2002. Data resulting from these field

trials are described in the Monsan to 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 enhanc ed drought tolerance of MON 87460 results from the introduction and controlled expr ession 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 primar ily as reduced yield loss relative to conventional corn when subjected to water-limiting conditions. When MON 87460 was subjected to well-watered condi tions, grain yield for MON 87460 wa s not notably different than conventional corn. Data provided by the Mons anto Company demonstrates that MON 87460 reduces yield loss under water-limiting conditions primarily by minimizing the effect of water deficiency on photosynthesis, stomatal conduct ance, 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 realiz ation 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 co mmercial corn production, average global annual losses due to moderate drought are approximately 15 percent, though losses can be much higher

under conditions of severe dr ought (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 th at 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 submitte d, APHIS must make a determination if the genetically engineered organism is unlikely to pos e 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 CF R 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 qua lity of the human environment 1 

### that may result from the deregulation of MON 87460 corn.

1.6 Coordinated Framework Review

MON 87460 does not contain a bi otechnology-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” incl udes “the natural and phys ical environment and the relationship of people with that environment” (40 CFR §1508.14)4 

### policy statement concerning regulation of products derived from new plan t varieties, including those produced through genetic e ngineering. The Monsanto Comp any initiated the consultation process with FDA for the commercial distribution of MON 87460, and submitted a safety and

nutritional assessment of food a nd 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 fu rther questions regarding M ON 87460 drought tolerant corn (FDA, 2010).

1.7 Public Involvement

APHIS routinely seeks public co mment on draft environmental asse ssments prepared in response to petitions to deregulate GE organisms. AP HIS does this through a notice published in the Federal Register. The issues discussed in this EA were developed by cons idering 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 rega rding the agricultural pr oduction of corn using various production methods, and the environmenta l 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 r eceived by the end of the 60-day period will be analyzed and used to inform APHIS’ determin ation 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 deve loped 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 (Mo rris 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 approximate ly 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 cent ral 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 e xporter of corn. From 2008 through 2010, the U.S. produced approximately 40 percent of the world’ s total corn harvest (F AOSTAT, 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 utili zed the majority of produced corn (39 and 35 percent, respectively), wherea s lesser amounts were used for exportation to foreign markets (15 percent), ending stock seed ( 13 percent), food and i ndustrial purposes ( 10 percent), and seed stock for hybrid seed production (0. 17 percent) (USDA-NASS, 2010a).

Each year, the USDA-Economic Research Servic e (ERS) updates its ten-year projections of supply and utilization for major field crops, in cluding corn, soybeans, a nd wheat grown in the U.S. At present, U.S. corn growers are on trac k 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 interna tional demand for U.S. corn, andwill 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 fr om the return of Conservation Reserve Program (CRP) lands to agricultural production (USDA-ER S, 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 dema nds (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 br oad scope of farming practices, ranging from farmers who only occasionally use s ynthetic pesticides and fertilizers to those farmers whose harvest depends on regular pestic ide and fertilizer inputs. This definition of conventional farming also includes the use of ge netically engineered (GE) varieties that have been deregulated by APHIS.

Growers can choose from a large number of co rn hybrids produced from traditional breeding or genetic engineering systems (NCGA, 2010). Adopti on of GE corn in the U.S. has significantly

increased since 2000 on both the state and national le vel, with 86 percent of all corn planted in 2010 representing a GE variety (Table 1). Add itionally, growers can also choose from several different crop management optio ns. Though specific details of th ese 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 co rn 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 w ould otherwise compet e with the crop for space, water, and nutrients. Field preparation is accomplished through a variety of tillage systems, with each system defined by the rema ining 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 resi due; and conservation tillage, including no-till practices requiring herbicide application on the plant residue from the previous season, is associated with at least 30 per cent crop residue and s ubstantially less soil erosion than other tillage practices (EPA, 2009). Cons ervation tillage has been associ ated with higher soil moisture retention when compared to c onventional and reduced tillage me thods (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 Mi dwestern U.S. (EPA, 2009).

Corn production typically involves the extensiv e 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, in sect, and/or microbial populations; and moisture to ensure normal pl ant 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 performan ce, fertilization with nitrogen, phosphorus, and potassium is widely pr acticed. In 2005 (the da te 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); phos phate 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-me tolachlor (23 percent) and Acetochlor (23 percent) repr esenting 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 Tefl uthrin (7 percent), Cyfluthrin (7 percent), and Tebupirimphos (6 percent) (USDA-NASS, 2006). While agricultu ral herbicide use trends resulting from the utilization of GE technologies are the subj ect of much debate (Benbrook, 2009; Brookes and Barfoot, 2010; Fernandez-Cornejo et al., 2009), it is generally agreed that in secticide use in U.S. crops has decreased since the in troduction of GE insect-resis tant crop varieties (Benbrook, 2009). In 2010, 63 percent of total U.S. corn acrea ge was planted with in sect-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 vi sible 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 in crease in floral asynchrony, and the abortion of fertilized kernels during ear de velopment (Westgate et al., 2004).

Corn generally requires a steady supply of mo isture, though the amount required is dependent on developmental stage. For example, prior to pol lination, corn generally requires 0.1 inches per day; during pollination and grain fill, this wate r requirement increases to a maximum of 0.35 inches per day (McWilliams, 2002). This moistu re 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 pr oduction 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 per cent; crop failure can also result under more severe drought conditions (Barke r, et al., 2005). While conve ntionally-produced corn hybrids have been produced to exhibit in creased drought toleran ce, the basic water re quirements of corn have not been overcome. Thus, these drought-tol erant varieties will not likely be grown outside

of current corn cul tivation 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 decr ease populations of soybean pests, such as soybean cyst nematode (Hoeft et al., 2000). Decisions about crop se quences are guided by ma ny factors, including economic return from differences in input cost, yield potential, and co mmodity prices. Crops used in rotation with corn vary regionally, but there ha s been an increase in the number of fields

that have a corn-to-corn rotati on, as opposed to rotati on to another crop other than corn. The10 

### increased adoption of corn-to-corn rotation, main ly in conventional and GE production systems, has been attributed to rising corn demand and prices (Hart, 2006; St ockton 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, a pproximately 8 percent of corn grown in the U.S. (2005/06 growing season) is specialty corn specified by buyers and end-us ers of corn (USGC, 2006, 2008). Specialty corns include: sweet, high oil, nutritiona lly-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 a lternatives 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 (trac eability) for Identity Pres ervation (IP) and quality assurance processes (e.g., ISO9001- 2000 certification), as well as contracts between growers and buyers that specify delivery agreements (Sunds trom et al., 2002). Systems used by specialty corn growers and end-users to maintain identity of the production include:

 

### Contracts – written agreements detailing res ponsibilities and duties of both parties including premiums for reaching goals and penalties for failing to attain specifications;

 

### Tracking and Traceability Systems – correct la beling of all products (planting seeds and harvested material) and testing procedures fo r identifying and detect ing acceptability of materials;

 

### Quality Assurance Processes – oversight on ha ndling 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 gu arantees to purchase final products. This may also require that the end-us er 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 Organizati on 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-Agri cultural 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 exclude d methods from adjoining land that is not under organic11 

### management. Organic production operations mu st also develop and maintain an organic production system plan approved by their accredite d certifying agent. Th is plan enables the production operation to achieve and document comp liance 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 cr ops (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 orga nic agricultural product (7 CFR 205.300). This oversight includes an annual review of the certified operation’s or ganic system pl an and on-site inspections of the certified operation and its reco rds. Although the Nati onal Organic Standards prohibit the use of excluded methods (7 CFR 205.272), they do not require testing for the presence of excluded methods. T hus, NOP certification is dependent on process and not product. The unintentional presence of the products of excl uded methods will not affect the status of an organic product or operation when the operation has not used 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 th eir harvests through vari ous 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 percen t) 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, totali ng 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 st ates 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”, Orga nic 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 mo isture from precipitation before the growing season, and supplemental irrigation during th e 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 a ll 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 gr oundwater contamination. Management practices that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the application of pesticides, herbicides, and fert ilizers. The primary cause of NPS pollution, however, is increased sedimenta tion following soil erosion. Agricu ltural pollutants released by soil erosion include sediments, fert ilizers, and pesticides that ar e introduced to area lakes and streams when they are carried off of fields by rain or irrigation wa ters (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, so il erosion-mediated sedimentation can increase fertilizer runoff, facilitating higher water turbid ity, algal blooms, and oxygen depletion in a body of water (EPA, 2005).

2.2.2 Soil

Arable land supports a rich and complex co mmunity 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 nutr ient cycling and releas e, and the concomitant

maintenance of soil stru cture and composition.

Cultivation of corn directly impacts the qualitative and quantitative attributes of soil. As with any agricultural system, land management opti ons, such as crop type, tillage, and pest management regime have notably greater effects on the biology of the soil th an the type of corn cultivated (Griffiths et al., 2007a ; Griffiths et al., 2007b). For ex ample, conventional tillage and mechanized harvesting machinery may disturb and expose the top soil surf ace layer, leaving the land prone to degradation. In turn, degradati on of soil structure and composition may lead to decreased water retention, a decrease in so il carbon aggregation and net positive carbon sequestration, and increased emission of radiat ively-active gases that contribute to the greenhouse effect (e.g., carbon dioxide (CO 2 

### ) and nitrous oxide (N 2 

### O)) (EPA, 2010b; Lal and Bruce, 1999). Additionally, as previously discusse d, land that is prone to degradation is also more likely negatively affect water resource qu ality 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, an d airborne allergens. The seven NAAQS criteria pollutants are carbon monoxide (CO), l ead, nitrogen dioxide (NO 2 

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

### ), particulate matter less than a nominal 2.5 micrometers in aerodynamic diameter (PM 2.5 

### ), ozone (O 3 

### ), and sulfur dioxide (SO 2 

### ) (EPA, 2010c). Emissions from crop agriculture can be broken down into two main categories

 emissions related to working fiel ds, such as dust and equipment emissions, and emissions from the soil and plants.

Agriculture activities (e.g., fiel d preparation, planting, and harves ting) may generate dust plumes (PM 10 

### and PM 2.5 

### ) (Holmén et al., 2006). For example, peak levels of particulate concentrations coincide with the peak agricultural harvest seas on in California’s Centra l Valley (Giles et al., 2006). Emissions released from agricultural e quipment (e.g., irrigation pumps and tractors) include CO, nitrogen oxides, reactiv e organic gases, particulate ma tter, and sulfur oxides (EPA, 2010b). Greenhouse gas (GHG) emissions from agricu lture (crops and livestock) are mainly in the form of methane and nitrous oxide (EPA, 201 0b). 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 co mpounds 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 pl ant surfaces and through wind

erosion and can be returned to the surface th rough 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 co mmodities 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 product s may all contribute greenhouse gases to the atmosphere (Aneja et al., 2009). Greenhouse gases collectively function as re tainers of solar radi ation, and agriculturerelated activities are re cognized as both direct (e.g., exhaust from equipment) and indirect (e.g., agricultural-related soil di sturbance) sources of CO 2 

### , methane (CH 4 

### ), and N 2 

### O (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., electri city production, trans portation, and related activities) (EPA, 2010a). Agricultural crop commodities may also affect dynamic geophysical soil processes, such as carbon turnover and se questration, through tillage and cropping system practices. In general, reduced/c onservation tillage practices fa vor more stable and increased carbon sequestration in the agro-environment (L al, 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 patte rns in precipitation, temperature, and duration of growing season, or ma y cause indirect impacts influe ncing weed and pest pressure (Rosenzweig et al., 2001; Schm idhuber and Tubiello, 2007).14 

### The impacts of GE crop varietie s 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 mon itor 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 th e 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 pr oduction is expected to adapt with improved cultivars and respons ive farm management (IPPC, 2007).

2.3 Animals and Plant Communi ties 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 rowcr op 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 sp ecies 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 a nd 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 ove rlap between nesting phenology and mechanized harvest (Johnson, 2000; Patte rson and Best, 1996).

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

functions both as food and cove r 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 De partment 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 ov er 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 co nsidered 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 al so 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 of15 

### weeds and available crops, such as corn and wheat (J. Smith, 2005; Sterner, et al., 2003). Thirteen-lined ground squirrels have the potenti al to damage agricultural crops, although they

can also be considered benefici al when eating pest insects such as grasshoppers and cutworms.

Although many of the invertebrate organisms f ound 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 polli nating plants (bees), contributing to the decay of organic matter (earthworms), cycling soil nutrien ts (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 geogr aphy. In certain areas, corn fields can be bordered by other agricultural fields (including t hose of other corn varieties), woodlands, or pasture and grasslands. From an agronomic perspective, the most relevant members of a surrounding plant community are thos e 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 wate r, nutrients, and light. U.S. corn yields are threatened by more than 200 weed species annu ally (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 a nd 35 percent, respectivel y (Bosnic and Swanton, 1997; Fausey et al., 1997).

Weediness

In the U.S., corn is not listed as a weed (C rockett, 1977; Holm et al., 1979; Muenscher, 1980). Furthermore, corn is grown throughout the world w ithout any report that it is a serious weed or that it forms persistent feral populations. Co rn 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 a ppearance 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 t ypically result in feral populations in subsequent years. Corn does not po ssess 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 variet ies currently under cultiv ation. The assessment encompasses a thorough consideration of the basi c 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 ge rmination, rate of growth and development, flowering, seed dispersal, seed yield, and pe rsistence of free-liv ing populations outside16 

### cultivation (See Appendix C). Mo nsanto collected phenotypic an d agronomic field data from

field trials conducted at 27 U.S. locations during the 2006 and 2007 gr owing seasons that included diverse agro-environments representative of the major corn-gro wing 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 characte rize 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. Sp ecies diversity and abundance in corn agroecosystems may differ between c onventional, GE, and organic produc tion systems. Relative to any natural ecosystem, species abundance and ri chness will generally be less in intensivelymanaged agro-ecosystems.

Many studies over the last ten year s have investigated the differen ces in biological diversity and abundance between GE and non-GE fields, particul arly those GE crops th at are resistant to insects (e.g., Bt crops) or herbicides (e.g., glyphos ate-tolerant or glufosin ate-tolerant crops). Among the numerous studies, conflicting results ar e often reported. Di fferent studies have

demonstrated decreases in biol ogical diversity or abundance due to GE crops engineered to accumulate insecticidal proteins or tolerate herbicide appl ication 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 spraye d 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 Rube rson, 2005; N. Weber, 2009; Wolfenbarger et al., 2008). Some reports show th at 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 change s 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). Sin ce biological diversity can be defined and measured in many ways, APHIS cons iders determining the level of biological diversity in any crop to be co mplex and hard to achieve concu rrence. Another difficulty with biodiversity studies is separati ng 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 expr ession in the GE crop plant.

2.3.4 Gene Flow

Gene flow is a biological proce ss 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 sp atial 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 re lated to pollen-mediated gene flow include the presence/abundance/distance of sexually-compa tible plant species; ove rlap of flowering phenology between populations; the method of pollin ation; the biology and amount of pollen produced; and weather conditions, in cluding 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 interventi on (e.g., chromosome doubling or embryo rescue) (Galinat, 1988; Mangelsdorf, 1974; Russell and Hallauer, 1980). However, teosinte (wild progenitor of corn) can sometime s be found as introduced populations in botanical gardens and as fera l 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 Fl orida (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 potential ity (Kermicle and Evans, 2010).

Corn plants do not produce clonal structures nor can corn plants produce vegetative propagules. Therefore, asexual reproduction a nd gene flow as a result of di spersal 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 cr op that produces abundant, large, and heavy pollen. The reproductive morphology of corn en courages cross-pollination between corn plants and there is no evidence (genetic or biologica l barriers) to indicate that ge ne flow is restricted between genetically modified, conventi onal, 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 se ed-mediated gene flow (see Appendix B for a detailed list). Spatial and tempor al isolation can be one of the mo st effective barr iers 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 instan ces of out-crossing can occu r (Ireland et al., 2006). For example, the NOP has requirements for organic plan s to address pollen flow from GE crops that include recommendations for spat ial isolation (Krueger, 2007; G. Kuepper, 2002; G Kuepper et al., 2007). The Association of Official Seed Cert ifying 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 fl ow 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 analys is to studies that conf irmed fertilization in the non-GE corn plants, and excl uded 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. Sandi vo 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 valid ated 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 stu dy 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 pote ntial reason for the discre pancy 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 (1 950) investigated the appropriate isolation distance for seed production in open-pollinated varieties, and not in hybrid varieties. Du e the biology of openpollinated varieties, these types of plants may be more receptive to polle n 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 Broo ks (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 fe ral 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 cu ltivation for survival (Galinat, 1988). Several key weedy traits that would cont ribute to crop escape, traits associated with ferality and volunteerism, have been selectivel y reduced in corn, resulting in a domesticated crop species not equipped for survival without management (Gould, 1968). Also, several trai ts 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 tig htly bound within a protective sheath of leaves, or husk (Ga linat, 1988). Corn seeds also l ack dormancy, preventing easy persistence between seasons in fiel ds 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 propertie s 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 shar e of corn that is gene tically engineered has risen from zero to 80 percent (U SDA-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 respons ibility of food and feed manuf acturers 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 lega l and regulatory requirem ents. 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, applican ts 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 comm ercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nut ritional, or other regula tory 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 devel oper by letter.

As noted by the National Research Council (NRC), unexpected and unintended compositional changes arise with all forms of genetic modi fication, 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 ha d fewer adverse effects on the environment than non-GE crops (NRC, 2010). Revi ews on the nutritional quality of GE foods have generally concluded that there are no signif icant 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 industr ies 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 Work er Protection Standard (40 CFR Part 170) in 1992 to further protect field workers from the hazar ds of pesticide exposu re. Furthermore, the Occupational Safety and Health Administration re quire 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 th e amounts and types of pest icides used and thus

the risks to workers. Pesticide registration, however, involves the de sign 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 cons umption, there is a gene ral concern regarding the impact of GE components on nutritional, allergenic, and toxi cological aspects of the food produced by livestock.

Similar to the regulatory control for direct hum an consumption of corn under the FFDCA, it is the responsibility of feed manuf acturers to ensure that the produc ts they market are safe and properly labeled. Feed derived from GE corn must comply w ith 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 intera gency discussions regardi ng possible issues.

2.6 Socioeconomic

2.6.1 Domestic and Trade Economic Environment

Domestic demand for corn in th e 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 bill ion bushels to total U.S. corn use. Demand is satisfied almost entirely by domestic supply, with few impor ts, 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 th e country (USDA-ERS, 2011b). In the 2009/10 marketing year, feed was approximately 40 perc ent of U.S. corn production, ethanol production was about 35 percent of U.S. corn use, food, s eed, and industrial uses were approximately 45 percent, and exports the remaining 15 perc ent (USDA-ERS, 2011b). Seeds constituted approximately 1.7 percent of domestic corn pr oduction, with 5.6 percent being used for high fructose corn syrup, glucose and dextro se, and corn starch (USDA-ERS, 2010c).

Corn is grown in the entire continental U.S. Despite this broad cultiva tion range, most U.S. production is centered in the Corn Belt. The Co rn Belt includes Iowa, Illinois, Nebraska, and Minnesota, and parts of Indian a, South Dakota, Kansas, Ohi o, Wisconsin, and Missouri, and represents approximately 80 percent of U.S. annual corn produc tion (USDA-NASS, 2010a).

Corn production requires approximately 20 inches of soil moisture during the growing season to achieve maximum yields. Many U.S. corn-produc ing 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 Ca lifornia are in the Great Plains area of corn production. Figure 2 shows the corn acres harveste d 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 Public ations, Ag Atlas Maps, C rops and Plants (Map 07-M164, USDA-NASS 2007b).



### Table 3: Relative importance of fa rms 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, Gro ss Domestic Product by State, Crop and Animal Production (NAICS 111 and 112); (b) National Agriculture Statistics Service, Ac reage, 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 in clude 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 pr oduction. In all listed states but Texas, farms generate a higher shar e of GDP than the U.S. average. The second column shows the share of corn in total crop acr eage as an indicator of the relative importance of corn in crop farming in each state. Given the va lue 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 th e U.S. Sales of organic products have been growing quickly, having grown from $1 billi on 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 be hind 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 pr event the contamination of excluded methods as dictated by the USDA-NOP. To o ffset 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, wher eas organic corn averaged $7.08/bushel (N. Weber, 2009).

The U.S. is the largest world expor ter 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 Ta iwan (USDA-FAS, 2010b). During the last half decade, the U.S. share of world corn ex ports 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 fo r commercialization in Ja pan. 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 af ter 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 percen t of its total weight (Greuere, 2006). Mexico imports and consumes regularly existing vari eties of GE corn (USDA-FAS, 2008b). South Korea has similar approval processes as Japan a nd 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 av ailable but given that U.S. corn imports are relatively small and that U.S. organic corn produc tion 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 de fined 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 co rn rotation, as well as land that could be converted from inactive cropland to active cropland, and la nd currently in the CRP that could be removed from the program and farmed.24 

### 3 ALTERNATIVES

This document analyzes the potential environm ental consequences of a determination of nonregulated status of Monsanto Company MO N 87460 corn. To respond favorably to a petition for nonregulated status, APHIS must determine th at 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 ri sk. Therefore APHIS must determine that MON 87460 is no longer subject to 7 CFR part 340 or the plant pe st provisions of the Pl ant 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: Conti nuation as a Regulated Article

Under the No Action Alternative, APHIS w ould deny the petition. MON 87460 and progeny

derived from MON 87460 would con tinue to be regulated articles under the regulations at 7 CFR

Part 340. Permits issued or notifications ackn owledged by APHIS would still be required for

introductions of MON 87460 and measures to en sure physical and repr oductive confinement would continue to be implemented. APHIS mi ght choose this alternative if there were

insufficient evidence to demonstrat e the lack of plant pest risk fr om the unconfined cultivation of

MON 87460.

This alternative is not the pr eferred alternative because APHI S 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 petit ion for nonregulated status.

3.2 Preferred Alternative: Determinat ion that MON 87460 CORN Is No Longer a Regulated Article

Under this alternative, MON 87460 and proge ny 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 notificati ons acknowledged by APHIS would no longer be required for introductions of MON 87460 and progeny derived from this

event. This alternative best m eets the purpose and need to respond appropriately to a petition for nonregulated status based on th e 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 determina tion of nonregulated status of MON 87460 is a response that is c onsistent with the plant pest provisions of the PPA, the regulations codified in 7 CF R part 340, and the biotechnology regulatory policies in the

Coordinated Framework.

Under this alternat ive, growers may have future access to MON 87460 and progeny derived from

this event if the de veloper 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 alte rnatives would be further considered for MON 87460. Based on this evaluation, APHI S rejected several alternativ es. These alternatives are discussed briefly below along with th e 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 th e release of MON 87460, including denying any permits associated with the fi eld testing. APHIS determined that this alternative is not appropriate given that APHIS ha s concluded that MON 87460 is un likely to pose a plant pest risk (USDA-APHIS, 2010).

In enacting the Plant Protecti on Act, Congress found that

[D]ecisions affecting imports, exports, and interstate move ment 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 H eads of Executive Depart ments and Agencies, the White House Emerging Technologies Interage ncy Policy Coordination Committee developed broad principles, consistent with Executiv e Order 13563, to guide the development and implementation of policies for oversight of emer ging technologies (such as genetic engineering) at the agency level. In accord ance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the followi ng principle, among others, to the extent permitted by law, when regulating emerging technologies:

“[D]ecisions should be based on the best re asonably 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 ma y 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 pr oduction. However, b ecause 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 in consistent with the statutory authority under the plant pest provisions of the Plant Protection Ac t and regulations in 7 CFR part 340.

APHIS also considered geographica lly restricting the production of MON 87460 based on the location of production of non-GE co rn in organic production systems or production systems for GE-sensitive markets in response to public conc erns 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, a nd will not exhibit a greater plant pest risk in any geographically restricted area. Therefore, such an alternative would not be

consistent with APHIS’ statutor y authority under the plant pest pr ovisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulat ory policies embodied in the

Coordinated Framework.

Based on the foregoing, the imposition of isolation di stances or geographic re strictions would not meet APHIS’ purpose and need to respond appropriately to a peti tion 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 isolat e 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 fo r GE products in non-GE production systems. APHIS notes there are no nationally -established regulati ons involving testing, cr iteria, 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 th e 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 acco rdance 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 Impact s 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 Laws28 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 change s but no significant differences29 

### 4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential environmental conse quences addresses the potential impact to the human environment from the alternatives analy zed in this EA, namely taking no action and a determination by the agency that MON 87460 doe s not pose a plant pest risk. Potential environmental impacts from the No Action Alte rnative and the Preferre d Alternative for MON

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

included for each affected environment. Certain as pects of this product and its cultivation would

be no different between the alterna tives: 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 rota tion, as well as land that could be converted from inactive cropland to active cropland, a nd land currently in th e Conservation Reserve Program (CRP) that could be removed from the program and farmed. C onversion of grassland, forest, or other land types to cropland as a result of dere gulating MON 87460 would be less likely because these types of conve rsions 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 e xpansion in irrigated U.S. corn production regions. The MON 87460 trait is intended to incr ease 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 an ticipated 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 Ce nsus of Agriculture to determ ine 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 reas onable, commonly accepted best management practices for their chosen system and varietie s during agricultural corn production. However, APHIS recognizes that not all farmers follow thes e best management practices for corn. Thus, the analyses of the environmental affects will al so include the assumption that some farmers do not follow these best management practices.

The environmental consequences will be di scussed under the context of the MON 87460 phenotype presented in the Monsanto 87460 Petition fo r 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-water ed conditions. When other indicators of MON 87460 agronomic performance are compared to a va riety of regionally-adapted corn reference hybrids and the near-isogenic c ontrol variety, MON 87460 neither si gnificantly nor consistently30 

### performs beyond the observed range of variati on, further reinforcing th e lack of increased agronomic performance in MON 87460 under we ll-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-i sogenic control corn variety. However, other measures of the MON 87460 phenotype do not si gnificantly deviate from the range of values produced by the near-isogenic control or region ally-adapted corn refe rence hybrids Combined with data demonstrating no significant diffe rences between MON 87460 or its control corn variety in rate of soil moisture depletion, root:shoot ratio, and co ld, heat, and salt stresses, the quantified agronomic attributes of MON 8746 0 under water-limited conditions confirms its single and predicted phenotype (Reeves, 2010). Th ese data provide multiple lines of evidence indicating that the cspB trait plays a physiological role in modulating plant drought response through increased photosynthetic effi ciency and does not provide an absolute increas e 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 prot ecting the health and value of Am erican agriculture and natural resources. Continued regulation of genetically engineered organisms and encouragement of best management practices, regardless of farmer decisi on to cultivate GE or non-GE crop varieties, represents two central, practical methods to mainta in and improve U.S. agricultural productivity.

At present, U.S. farmers are projected to incr ease 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-produc ing regions of the U.S. GE corn varieties represent a progres sively 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 varietie s represent either herbicide-tolerant (e.g., glyphosate-, glufosinate-tolera nt or other herbicide) or insect resistant (i.e., Cry protein expression) varieties, an incr easing proportion are varieties with multiple stacked traits (i.e.,

herbicide-tolerant and insect-resis tant) (USDA-ERS, 2010a).

During the market year September 2009 throug h 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 percen t was used for animal feed and residuals, 35 percent was used for biofuels production, 10 percent was used fo r food and industrial pur poses (not including alcohol for fuel), 0.17 percent was used as se ed stock for hybrid seed production, 13 percent remained as ending stock seed, and 15 percent wa s 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 indi cated by USDA-ERS projections and previous31 

### trends of GE corn adoption (USDA-ERS, 2011b). Increased demand for animal feed in the livestock industry, favora ble net returns for corn ethanol production, and the readily available number of regionally-adapted corn hybrid varieties is likely to su stain 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). Fo rmer 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 re duction in U.S. CRP acreage from 2011 to 2020 (USDA-ERS, 2011b).

Conventional corn productio n 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 productio n and demand. Market demand across all consumer sectors is anticipated to dictat e 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 un der 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 co rn-producing areas that are subject to moderate drought stress. As indicated in data presented by the Monsanto Company and the APHIS Plant Pest Risk A ssessment 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 simila r to that of conventi onal corn. Like other domesticated corn varieties, M ON 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 conventiona l 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 routin ely support high levels of corn production are unlikely to adopt MON 87460 due to a lack ofimproved agronomic performance under wellwatered conditions (Figure 3). These well-wat ered corn production regions generally do not require supplemental irrigation and represented 85 percent of total corn cu ltivation 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 pr imarily 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 sim ilar measures of growth and developmental

characteristics relative to conventional corn. Corn production regions subject to frequent moderate drought conditions may require supplemen tal irrigation, includi ng the western dryland Great Plains and similar regions , and these represented 15 percen t of all corn production regions in 2007. A determination of nonregulated stat us of MON 87460 under the Preferred Alternative is unlikely to significantly increase future co rn acreage beyond USDA-ERS projected expansion in irrigated U.S. corn production regions. Th e MON 87460 trait is inte nded to increase grain yield security under conditions of moderate wate r stress. Minimum moisture requirements are

similar between MON 87360 and c onventional corn. When grow n in water-limited field and greenhouse conditions, MON 87460 corn exhib its classic drought sensitivity symptoms, including reductions in yield, pl ant height, ear height , seedling vigor, and expected changes in plant height, chlorophyll content, and leaf ro ll (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 incr easingly severe growth and developmental symptoms. Taken in total, these data demonstrat e that the negative effects of drought stress in

MON 87460 are not alleviated a nd 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 curre nt irrigated corn production areas.33 

### It is prudent to acknowledge, however, that the reduced yiel d phenotype of MON 87360 does not exceed the natural variation observed in regi onally-adapted varieties of conventional corn (representing different genetic backgrounds) (Reeve s, 2010). Thus, equally comparable varieties produced through conventional bree ding techniques are readily av ailable in irrigated corn production regions. Despite the av ailability of conventional drought tolerant corn varieties in these irrigated corn production regions, recent agr onomic trends suggest that increases in corn acreage are often undertaken at th e 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 produc tion 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 acr eage in 2007 was observed across the U.S. in general, and was not specific to the Great Plains dryland re gion (USDA-ERS, 2010b). This further suggests that MON 87460, with its reduced yield phenotype not exceeding that observed in conventionally-produced drought tolerant corn varietie s, will not significantly alter present trends in irri gated corn acreage.

Several reasons can be advanced for why corn acr eage will not expand into areas not currently used for corn production. Existing drought tolerant varieties and conventional corn have similar moisture requirements and physiological res ponses 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 irri gation. Although conven tionally-produced drought tolerant corn has been accessible to growers, there has been no associated e xpansion into novel areas in corn production regions. For these reasons, APHIS doe s not anticipate that a determination of nonregulated status of MON 8746 0 will significantly increase co rn acreage beyond projected

values nor alter current tr ends in crop production.

Table 5. Acreage for major field crops and Conservation Reserve Program (CRP) assumptions, long-term pr ojections (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 282.6 276.7 287.2 285.0 283.0 281.9 280.8 280.8 281.2 281.6 281.6 281.534 

### 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 Acrea ge and U.S. Cultivation Range

Cumulative effects of a determination of non regulated status of MON 87460 are unlikely.

Neither the No Action Alternativ e nor Preferred Altern ative of a determina tion of nonregulated status of MON 87460 will directly cause an incr ease in agricultural acreage devoted to corn production beyond projected USDA-ERS increases. There are no anticipat ed 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 larg e number of corn hybrid varieties that are readily available to growers.

4.3.2 Cropping Practices

Corn is an extensively manage d crop plant, requiring significant management considerations regarding tillage, agricultural inputs, and ro tation strategy. Decisi ons concerning corn agronomic practice are dependent on grower want and need, and ultimately reflective of external factors including geography, weed and disease pre ssure, economics of management of yield, and production system [rotation] flexibility (G iannessi, 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 increa sed vigor and increased resistance to pest and disease of hybrid corn varieties relative to inbred corn lines. Consequently, choice of manageme nt practice often dictates mark etability of a corn product, with certain agricultural consumer sectors stip ulating requirements and restrictions regarding corn production methods.

Of the numerous agricultural inputs required fo r corn grain production, moisture readily impacts growth and yield. Inadequate moisture at any st age of development is detrimental to the plant, 0 20 40 60 80 100

0 5000000 10000000 15000000 20000000 25000000

1992 1997 2002 2007%irrigatedCornacreage

Year

Total acreage Irrigated acreage Percent irrigated acreage35 

### though water deficit during grain fill is most str ongly 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 durati on of stress duri ng grain fill can cause a 40 to 50 percent yield reduction (Hesterm an and Carter, 1990). In contrast to water stress impacts during vegetative growth, subse quent irrigation after wa ter-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 c ontinue 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 be tween 1000 (Pioneer, 2008) and 4000 (Monsanto, 2010). Widespread adoption of GE corn will c ontinue in the U.S., easily accounting for the majority of corn produced.

Current corn management practi ces are likely to continue under the No Action Alternative. Growers make choices to use certain pesticides ba sed on weed, insect and disease pressures, cost of seed and other inputs, techno logy fees, human safet y, potential for crop injury, and ease and flexibility of the production syst em (Olson and Sander, 1988). No -till production of corn will

continue to increase under the No Action Alternativ e, effectively mitigating the negative impacts of conventional tillage and asso ciated soil erosion (Fawcett and Caruana, 2001). Additionally, agronomic practices involvi ng the application of exte rnal inputs, such as he rbicide, pesticide, and moisture, will remain as it is practiced today. As an example of the pesticides used during the production of field corn, the Pe sticide 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 pesticid es (e.g., herbicides, insecticides, fungicides) used in California corn production. Any effects due to crop rotation, tillage and pest icide 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 t oday, with market demand and available technology strongly influenci ng corn rotation practic es, under the No Action

Alternative.

4.3.2.2 Preferred Alternative: Cropping Practices

Under the Preferred Alternative, a determin ation of nonregulated status of MON 87460 is unlikely to significantly impact cropping practi ces in non-irrigated corn production regions, as these regions already receive su fficient precipitation to limit adoption. These corn cropping practices include tillage choices , type and frequency of agricu ltural inputs, and crop rotation strategies. Consequently, corn cropping practices in these regions are unlikely to be significantly impacted by MON 87460 due to th e 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 im pact corn cropping practices. MON 87460 exhibits similar agronomic and growth characteristics to conventional corn, with th e exception of reduced grain yield loss under water-limiti ng conditions. Consequently, it is not anticipated that MON36 

### 87460 will significantly differ from conventional co rn in responding to fertilizer or moisture application. In particular, MON 87460 displays similar soil moisture depletion rates and physiological responses to water-limiting conditi ons as conventional corn, strongly suggesting that irrigation practices for optimal grai n yield between MON 87460 and conventionallyproduced drought tolerant corn vari eties 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 tole rant or insect resist ant traits in MON 87460, pesticide use is not anticipated to change existi ng 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), a doption 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 appl ication. Introduction of herbicid e-tolerant corn varieties, in particular glyphosate-tolerant co rn, has not significantly affect ed corn acreage managed with total herbicide application (Figure 5). Howeve r, MON 87460 may facilitate a shift in specific herbicide product use. While use trends in the six most frequen tly applied herb icides in 2005 demonstrate relatively stable to tal 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 a pplication, if the drought

tolerant trait were offered without an insect-re sistance trait in MON 874 60. Given typical corn offerings, corn hybrid varieties produced with MON 87460 will be highly likely to be stacked with other nonregulated pesticide traits since stac ks 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 demons trated by previous trends (USDA-ERS, 2010a). Accordingly, because of the popular ity of herbicide tolera nt crops, levels of tillage are likely to continue as currently pract iced.

Table 6. Percentage of herbicid e-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 MO N 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 co rn varieties. The requirement s for crop rotation, tillage, and herbicide and pesticid e use for both MON 87460 and any hybr id 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 cer tified organic corn acreage represents an increase of approximately 9 pe rcent from the 131,000 cer tified organic acres in 2005. Based on certified organic trends, it can be anticipated that organic acreag e 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 mana gement to prevent unintended contact with prohibited substances (7 CFR 205.272). Organic production operati ons must also develop and maintain an organic production system plan a pproved by their accredited certifying agent (7 CFR 205.201). This plan enables the production opera tion to achieve and doc ument compliance with the NOP, including the NOP prohi bition on the use of excluded methods. Excluded methods 0 20 40 60 80 100

2000 2001 2002 2003 2005%ofacresapplied,A.I.

Year Total herbicide

Atrazine

Glyphosate

Acetochlor

Nicosulfuron

S

‐ Metolachlor

Mesotrion38 

### include methods used to genetically modify orga nisms or otherwise infl uence their growth and development by means not possible under natural conditions or processes.

Typically, there is more than one method for fa rms under organic practices to prevent unwanted pollen or seed from entering their fields includi ng: 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 descripti on 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 mon itor 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 farm ers know that they are using organic production practices and request that the nei ghbors also help the or ganic farmer reduce contamination events (Krueger, 2007; NCAT, 2003). Thus, commonly us ed production practices for corn, and the practical methods typically used by corn farmer s 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 pl ans and practices to prevent the likelihood of unwanted substances is best repr esented 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 assu me 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 develope d for organic producti on, 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 th e regulations at 7 CFR part 340. This however, will not change the ready avai lability 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 orga nic commercial corn production w ill not change and will remain

the same under the No Action Alternative. Pl anting 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 incr ease under the No Action Alternative.

4.3.3.2 Preferred Alternative: Organic

A determination of nonregulated status of MON 87460 is unlikely to signif icantly impact organic farmers that choose not to plant or sell corn products produced through genetic engineering or other non-organic production syst ems. Despite the wide-spread adoption of conventional and GE corn in the U.S. that amounted to 99.8 percen t of total corn producti on in the U.S. in 2007, organic corn production has al so continued to expand in recent years (USDA-ERS, 2010d). This continued expansion of organic corn acr eage, though minor relative to non-organic national and state corn production, reinforc es the capacity of current organi c system plans to avoid use of excluded methods (and thus, loss of NOP certific ation) and the efficacy of these plans to39 

### increasingly produce agricultural products to meet demand of ta rget markets in spite of the overwhelming presence of non-or ganic farming systems.

States that represented major organic corn production areas (> 10,000 acres) in the 2007 Agricultural Census included Iowa, Michigan, Mi nnesota, New York, and Wisconsin (Table 7). Organic corn production in these states repres ented 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 th is, or any other organic corn pr oduction region, has lost organic certification status. Thus, presently certifie d 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, organi c corn production woul d 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 pr oduction (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 0.27440 Table 7. Non-organic and organic corn pr oduction (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 calcul ated from the 2007 Agricultu ral Census (USDA, 2009)



### 4.3.3.3 Cumulative Effects: Organic

Under both the No Action Alternative and the Pr eferred Alternative, a determination of nonregulated status of MON 87460 will not change market demands for corn produced through organic methods. A determination of nonregulat ed 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 cor n, and a determination of nonregulated status of MON 87460 is not anticip ated to significantly increase GE corn41 

### production in these areas. Thus, presently-approv ed methods for the pro duction 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 wa ter 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 genera lly requires more water for optimal grain yield; however, this amount is generally less than dicot crop plants, due to increased photos ynthetic 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 factor s affect that NPS pollution frequency and amount, including the type of cr op cultivated, plowing and tillage, and the application of fertilizers, herbic ides, and pesticides (EPA, 2005). Discharge pollutants can occur

in the form of direct chemical c ontaminants (fertilizer, herbicide, or pesticide derived) or direct physical particulates (erosion-re lated 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 co ntinue 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-l imiting conditions. When subject to water deficit, both MON 87460 and conventional corn di splay similar magnitude s of effect on corn drought stress indicators, includin g but not limited to plant hei ght, days to 50 percent pollen shedding/silking, grain moisture, and leaf chlor ophyll content. The reduced yield loss phenotype of MON 87460 is not enabled by in creased water uptake, as demons trated by several lines of evidence. Firstly, patterns of shoot and root fresh/dry weight between MON 87460 and conventional corn are not signif icantly different under well-water ed 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 patte rn, 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 depl etion studies, where no si gnificant differences in42 

### soil moisture depletion rates were obser ved between MON 87460 and conventional corn (Reeves, 2010). Taken in total, the physiological evid ence and record ed measures of moisture depletion strongly indicate th at 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 wate r. A major contributing factor to NPS pollution is soil erosion-mediated sedimentatio n and the resulting detrimental effects on soil structure and agrochemical runoff. The correla tion between tillage prac tice and soil erosion is well documented, as is the correla tion between no-tillage or redu ced-tillage production systems, adoption rates of herbicide tolerant crops, and im proved soil structure and quality. No-tillage or reduced-tillage strategies in co rn production are contingent on continued herbicide use. MON 87460 is not anticipated to significantly affect herbicide us e, and thus, is not anticipated to significantly affect no-till or redu ced-till systems curren tly 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: Wat er Usage and Water Quality

A determination of 

### nonregulated status of M ON 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 strategi es 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 syst em modifies soil through its cl ose association with several microbial groups such as bacteria, fungi, and prot ozoa (Bais et al., 2006). These interactions are generally complex and occur through multiple path ways. Plants can have direct or indirect chemical, physical, and biological effects on the so il. 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 nut riment cycling capacity of the soil (Hoeft, et al., 2000; OECD, 2003). Specific crop management practic es used for GE plants, such as pesticide applications, tillage, and application of inorgani c and organic fertilizers can alter soils and the microbial and arthropod populati ons associated with it.

4.4.2.1 No Action Alternative: Soil

Under the No Action Alternative, APHIS woul d 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 re leases, and would be minor if any, due to the small proportion of land compared to commerci al corn production acreag e. Therefore, there would be negligible impacts on soil under the No Action Alternative.43 

### 4.4.2.2 Preferred Alternative: Soil

Under the Preferred Alternativ e, MON 87460 is not an ticipated to signifi cantly impact the quality of the soil on which it is cultivated, nor is it likely to significantly affect microbial populations or arthropod populatio ns 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 unlik ely to be significantly impacted by a determination of nonregulated status of MON 87460, as herbicide application strategies will continue to be avai lable to facilitate use of low im pact tillage practices.

Microbial and arthropod soil populations may be impacted by a corn crop through degradation of plant tissue following harvest and di rect interaction with soil fauna through the corn root system. Compositional analysis of MON 87460 forage ti ssue (i.e., stems and leaves) revealed no significant or consistent differences between it a nd conventional corn. Additionally, analysis of the gene products produced by MON 87460, the ne omycin 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 se lection 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 th e 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 gr ain 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 envi ronment for soil as a result of the Proposed Action. Therefore, no cumulative effects on the a ffected environment for Soil were identified as

a result of the Prefe rred Alternative.

4.4.3 Air Quality

Air quality may be affected by a variety of agri cultural-related activities, including smoke from agricultural burning, tillage, tra ffic and harvest emissions, pest icide drift from spraying, and nitrous oxide emissions from the use of nitrogen fertilizers (Aneja, et al ., 2009; Hoeft, et al., 2000). These agricultural activitie s individually have potentially adverse environmental impacts on air quality. Tillage contributes to the release of GHGs because of the loss of CO 2 

### to the atmosphere and the exposure and oxidation of soil organic matter (J. B. Baker et al., 2005). Emissions released from agricultural equipm ent (e.g., irrigation pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic gases, particul ate 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 fr om drift and diffusion. Pesticides may volatilize after application to soil or pl ant 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. Ai r quality would still be affected by agronomic44 

### 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 pesticid e application, are not likely to be different

between MON 87460 and conventional co rn. 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 imp act 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 intens ive management practices between

MON 87460 and conventional corn.

4.4.3.3 Cumulative Effects: Air Quality



### APHIS has not identified any cumulative impact s for this issue. A determination of nonregulated status of MON 87460 is expected to on air quality du e to similar cropping practices

between MON 87460 or conventional corn. Bo th MON 87460 and conventional corn require intensive cropping practices for optimum grain yi eld, resulting in no cumulative impact on air quality related to those cropping practices.

4.4.4 Climate Change

U.S. agricultural crop production is identifie d as a major source of GHG emissions, second only to the U.S. energy sector. Crop production activiti es 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. Cla sses of crops planted are relevant to clim ate change, through cropdependent management practices and soil impact s. Additionally, geog raphic 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 organi sms 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 woul d not deregulate MON 87460, and its use would be limited to areas APHIS has approved for re gulated releases. Agronomic management practices and phenotypic char acteristics regarding MON 87460 are similar to those of conventional corn; thus, impact between corn varieties would be mi nimal. Additionally,

measurable effects from these c onfined 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 signif icantly affect current corn management practices. Management decisi ons regarding agricultura l affecters of climate change, including tillage, agricultural chemical application, and rotational strategies are not anticipated to differ between MON 87460 and conve ntional 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 er osion, stabilizing soil quality attributes and reducing GHG emissions.

Agronomic performance and phenotypic char acteristics of MON 87460 is not significantly different from conventional corn, with the exception of reduced yield loss under water-limiting conditions. Accordingly, the physical imp act of MON 87460 on climate change is not anticipated to be significantly different from th at 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 M ON 87460 and conventional corn.

4.4.4.3 Cumulative Effects: Climate Change

APHIS has not identified any cu mulative 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 signifi cantly impact current corn production strategies, and thus, current agri cultural impacts on climate change.

4.5 Animal and Plant Communities

4.5.1 Animal Communities

Corn production systems in agriculture are host to many anim al species. Mamm als 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 ch ange 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 s upports Monsanto’s conclusions that

MON 87460 is considered safe for animal consum ption. 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 fo r new corn production, thes e 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 c onventionally 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 evaluati on 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 includi ng (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 observab le 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 grow th and development, including vegetative and reproductive gr owth, (2) germination and dorm ancy, (3) pollen viability and morphology, (4) plant interacti ons 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 specie s exposed to MON 87460 showed a dverse consequences and that

MON 87460 is not different in its environmental interactions relative to conventional corn. Because no differences in phy sical traits or characterist ics 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 f eed 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 food s, and has a hi story of safe consumption. The FDA acknowledge d that enzyme preparations from Bacillus subtilis are generally recognized as safe (FDA, 1999). Th e petitioner assessed the risks to humans and animals from the transgene proteins pres ent 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 pr otein represents no more than 0.00007 percent of the total protein in the grain of MON 87460 , and neither transgene pr otein shares any amino acid sequence similarities with known allergens, gliadi ns, glutenins, or protein toxins that have

adverse effects on mammals. Beca use there is no toxicity or a llergenicity 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 proteins47 

### of MON 87460 (Appendix A), which demonstrated a l ack of toxicity and allergenicity of MON

87460 for human and animal consumption.

Former CRP land returned into agricultural produ ction 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 simila r habitat. The animals that could be present in CRP areas would vary depending on the re gion 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 t urn, the native vegetation provided habitat to wildlife, most notably birds. Many bird speci es, 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 (Fe rris 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 measur e. As discussed in Cropping Practices Section (4.3.3.2 Preferred Alternative), MO N 87460 does not contain any herb icide tolerant or insect resistant traits and adoption of MON 87460, e ither 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, e ither directly or indirectly, are expected from deregulating MON 87460; i mpacts 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 la ndscape surrounding a corn field varies depending on th e 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 weed s, around a corn field depend on the area where the corn is planted. A variety of weeds dwell in and around corn fiel ds; 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 th e U.S. The cumulative effects analysis for this

issue is found below at “Cumulative Eff ects: Plants, Animal s, 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 invasi ve in natural environments, compete withnative vegetation, or have any different effect on habitat than conventional corn (USDAAPHIS, 2010). Corn struggles to survive withou t human assistance and does not possess traits

that are characteristic of succes sful 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 cr op. Physical or chemical methods are often applied to eradicate these corn seedlings. Any seedlings not remove d do not typica lly result in feral populations in subsequent years.

Possible Weediness of MON 87460

For the majority of the agr onomic traits assessed, there we re no statistica lly significant differences between MON 87460 and nontransgeni c control (Reeves, 2010). No biologically meaningful differences were detected in th e 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 conven tional corn for germination and dormancy characteristics (Reeves, 2010). No differences were detected in pollen morphology or viability

between MON 87460 and the contro l (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 on e 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 devel opment exhibited higher yields under drought stress than ones with accelerated early de velopment of roots (Bruce et al., 2002). It has been reasoned that the improved performance of corn cultivar s to drought stress probably comes from better water use efficiency (Messmer et al., 2009). Fi nally, 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 interven tion, and that its cultivation

will not interfere with the cultivation of other co rn hybrids or result in its uncontro lled 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 th e potential for gene flow to occur from MON 87460 to sexually compatible wild relatives. As stated previously, cultivated corn is sexually compatible with its closes t relative, teosinte, and w ith members of the genus Tripsacum

, although to a much lesser degree (Mangelsdorf, 1974; OECD, 2003; Wilk es, 1967). Corn and teosinte are genetically compatible, wind-polli nated, and can hybridize when close to each other, which is only likely to occur in Mexico a nd Guatemala because teosinte is not present in the U.S., except for a few s mall 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 co rn but can hybridize with corn, although it is very difficult and requires sp ecial techniques, and the hybrids have a high degree of sterility and are genetically unstable (Mangelsdor f, 1974). Crosses between corn and Tripsacum dactyloides can be made, but only through human in tervention and, even then, it is extremely difficult (CFIA, 1994). MON 87460 is not likely to hybridize wi th sexually compatible species

in the U.S. because of differen ces in factors such as flowerin g time, geographical separation, and development factors (Doebley, 1990a, 1990 b; 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 th ese 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 measur e. As discussed in Cropping Practices Section (Preferred Alternative), MON 87460 does not contain any herbicide to lerant or insect resistant traits and adoption of MON 87460, either on its own or stacked with currently deregulated pesticide traits, is not anti cipated 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 depe nds on the amount of CRP land converted to agriculture. However, the USDA (USDA-ERS, 2011 b) sees no increase in corn acreage from 2011 through 2020 and little change in CRP land; and an increas e in corn in 2011 appears to be at the expense of wheat acreag e. As previously noted, c ropland in the U.S. has been declining as more cropland has been converted to other type s 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; i mpacts 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, variet ies have been developed for food proces sing needs (e.g., waxy corn), consumer qualities (e.g., blue co rn or white corn), or for use as a vegetable (e.g. sweet corn). In conventional agriculture, farmer s 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 da mage 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 ve getation within and around the agro-ecosystem; 2) permanence of various crops within the system; 3) intensity of50 

### management, including selection and use of ins ecticides 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 Alternativ e, environmental releases of MON 87460 would be under APHIS regulation. Animal and plant species that t ypically inhabit seed corn and commercial production systems will be continue to be affected by th e management plan of t ypical conventional corn production, which includes the us e of mechanical, cultural, and chemical control methods.

4.5.3.2 Preferred Alternative: Biodiversity

As discussed above in Plant a nd Animal Communities (of Envir onmental 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 he rbicide or pesticide application. Cultivation of MON 87460 seed re quires the same agronomic practices as conventional corn production. Animal and plan t species that typically inhabit seed-corn production systems will be managed as in conven tional corn production, likely with the use of mechanical, cultural, and chem ical 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 Acti on Alternative. Therefor e, there would be no impact to biodiversity unde r 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.

T he replacement of a different crop (such as soybeans) to MON 87460 may likely result in a shift in biodiversity (different animals and plan ts might be present). However, as previously stated, biodiversity in any agricultural system is highly managed, and ro tating from one crop to MON 87460 would not be likely to affect the ov erall species richness or abundance.

If farmers substituted organic corn cultivat ion with MON 87460 cultivation, local biodiversity could decline. Bengtsson et al. (2005) analy zed 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 conventiona l 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, th e 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 pl ants responded positively to organic farming, while non-predatory ins ects and pests did not. The authors suggest th at positive effects of organic farming on species richness can be e xpected in intensively managed agricultural51 

### landscapes, but not in small-scale landscapes co mprised of many other habitat types (Bengtsson et al., 2005).

The biodiversity in agricultural systems is high ly 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 herbic ides 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 agricultu re and the types of herbic ides 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 us ed to grow corn, the impacts would represent only 3 percent of all existing co rn 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 ot her 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 8746 0 on plants were determined because MON 87460 does not possess weedy characteristics, and is unlik ely to introgress into wild plants or to corn agriculture. Consequently , no cumulative impacts would be expected.

There may be some potential for certain foreseeabl e actions to contribute to cumulative impacts in conjunction with adopti on of MON 87460. One action coul d include industry stacking together multiple drought tolerant corn varieties with additional traits such as insect resistance, and herbicide tolerance. Non-regulated GE tr aits 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 pesticid e application, is not anticipated to be si gnificantly 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 shif ts in pesticide product use ma y occur. However, also as discussed in Cropping Practices Section (4.3.2.2 Preferred Altern ative), any shift of specific pesticide product use would likely be mitigat ed by hybridization of MON 87460 with other deregulated herbicide-tolerant or insecticide traits that are likely to be al ready present in the area.52 

### 4.5.4 Gene Flow

4.5.4.1 No Action Alternative: Gene Flow

Under the No Action Alternativ e, environmental releases of MON 87460 would be under APHIS regulation. Horizontal gene flow from corn to ot her organisms would be unlikely to occur. Gene flow to other GE and conventional crops, to the exte nt 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 repr esent 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. U nder well-watered conditions, MON

87460 did not notably differ from non-GE comparab le varieties (Reeves, 2010). No evidence of changes to pollen attributes or seed attribut es 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 (suc h as some organic crops), distance between a pollen source and recipient plants, and the imp act of environmental factors such as wind, temperature, and humidity on viabilit y 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 ex ception 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 sp ecies from the majority of U.S. corn production, make the

occurrence of natural crosses in th e 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 va rieties. As reviewed by Sanvido et al., 2008, pollen-mediated gene flow decreases rapidly with increasing distance from source crop fields, regardless of co rn 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 croppi ng 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 cond itions (Reeves, 2010), it can be suggested that drought conditions may increase the risk of po llen-mediated gene flow due to less pollen abortion or changes in floral phe nology. However, no evidence for changes in pollen structure, function, abundance, or dispersal was reporte d in MON 87460 under water-limiting conditions (Reeves, 2010). Under conditions of drought, corn plants (convent ional, organic, or GE) can continue to produce pollen, but the window of fert ilization is shortened because of the delaying effects of drought on deployment of female repr oductive 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 expe cted to differ from conventional corn53 

### and would be limited, in part, because of shortene d 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 (i ncluding organic seed producers) use standard procedures to assure s eed quality. In research conducted to evaluate MON 87460 (Reeves, 2010), the expression of the cspB conveys a drought resi stance 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), persis tence of the corn coul d not be expected to produce a feral population because the sh atter 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 varietie s 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 be come a greater weed, because the trait confers reduced yield loss and does not a lter any other corn traits.

4.5.4.3. Cumulative Eff ects: 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 va riety of corn has resulted in a change in the properties associated with pollen-mediated or seed-mediated ge ne flow from corn. Therefore, there are no expected cumulative impacts.

4.6 Human Health

This section focuses on whethe r the proposed action affects overa ll public health and worker safety. For MON 87460, the evalua tion of human health impacts i nvolves 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 concer ns relating to MON 87460 center on food and product safety, including alle rgenicity, 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 (Secti on 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 respons ibility of food and feed manuf acturers 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 lega l 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 a bout 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 theref ore 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 tradi tional and GE corn would not change under this

alternative. The status of Monsanto's consulta tion 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, bei ng present in many plants and common bacteria, including species that are norma lly present in gastrointestinal flora. Cold shock proteins have no known t oxicity and are not associated with pathogenicity. Based on the evidence provided (Reeves, 2010), the CSPB and NP TII proteins are antic ipated to present no potential adverse effects to e xposed organisms, including huma ns, 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 NP TII proteins conducted on mice did not result in any observed adverse effects, even at the highest test ed dose levels (Smedl ey, 2008). A dietary safety assessment was performed to evaluate th e 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 a nd NPTII to the estimated dietary intake, also called the margin of exposure (MOE), was esti mated to be greater th an 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 gr eater 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, gliadi ns, glutenins, or protein toxins which have adverse effects on mammals (Bur zio 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 pe rcent of identity with CSPs present in other bacterial species widely used by the food industry and with CSD-cont aining proteins in plant species used as food.55 

### The CSPB protein is homologous to th e 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 conduc ted with the CSPB protein dem onstrated that the full-length protein is rapidly digested in si mulated gastrointestinal fluid, a characteristic sh ared among many proteins with a history of safe consumption. Proteins that are rapidly digestible in mammalian gastrointestinal systems are unlikely to be a llergens 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 mu ltiple 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 comm ercial crops that have undergone previous safety assessments (e.g.,

so far NPTII was used as a selectable mark er in 28 petitions deregulated by APHIS BRS; http://www.isb.vt.edu/cfdocs/biopet itions1.cfm), including corn.

Compositional comparisons between MON 87460 a nd conventional corn presented by Monsanto showed no biologically meaningful differences for grain and forage compositions either for major nutrients or for secondary metabolites (Reeve s, 2010). Therefore, ba sed on this data, it is

reasonable to assume that th e 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 sc ientific 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 Alternativ e, 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 rela ted to the Preferred Alternative. APHIS has determined that there are no past, present, or r easonably foreseeable actions that would aggregate with effects of the proposed ac tion to affect public health. Th erefore, there are no cumulative

effects identified for this issue.

4.6.2 Worker Safety

EPA’s Worker Protection Standard (WPS) (40 CFR Part 170) wa s published in 1992 to require

actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS offe rs protections to more than tw o and a half million agricultural56 

### workers who work with pesticides at more th an 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of pe rsonal protective equipment, restricted entry intervals following pesticide application, decontamination supp lies, 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 curren tly 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., pestic ides) for conventional corn. Therefore, worker safety issues associat ed with the agricultural producti on 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 practi ces and the use of pestic ides during agricultural production of MON 87460 would remain the same under both alternatives. APHIS has determined that there are no past, present, or r easonably foreseeable actions that would aggregate with effects of the proposed action to impact wo rker 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 c onsidered one of the primary

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

bacteria is a concern. This section addresses the use of M ON 87460 as animal feed, and the potential effects of this use on liv estock 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 woul d 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 bene fits 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. Additionall y, no gene transfer to gastrointestinal flora is expected. Both CS BP 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 ti ssues from MON 87460 confirmed that the corn grain and forage derived from MON 87460, and th e intended foods and feeds derived from MON 87460, can be considered compositionally and nutritionally equivalent to conventional corn hybrids that have a history of sa fe consumption that are currently in commerce. Therefore, any food, such as meat and milk, derived from anim als that are fed MON 87460 are not expected to

differ from food derived from an imals fed conventional corn.

The results of a dietary safety assessment indi cate 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 gastroin testinal tract of humans, animals, or the environment, is remote (http://vm.cfsan.fda.gov/~dms/opa-armg.html).

Based on the assessment of data pr ovided by the applicant and review of additional literature, the

Preferred Alternative is not anticipated to ha ve 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, pr esent, or reasonably fo reseeable actions that would aggregate with effects of the proposed action to affect lives tock 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 ec onomic 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 th e 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 bill ion bushels to total U.S. corn use. Demand is satisfied almost entirely by domestic supply, with few impor ts, 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 th e country (USDA-ERS, 2011b). In the 2009/10 marketing year, feed was approximately 40 perc ent of U.S. corn production, ethanol production was about 35 percent of U.S. corn use, food, s eed, and industrial uses were approximately 45 percent, and exports the remaining 15 perc ent (USDA-ERS, 2011b). Seeds constituted approximately 1.7 percent of domestic corn pr oduction, with 5.6 percent being used for high fructose corn syrup, glucose and dextro se, 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 rene wable 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 etha nol production is projected to slow, however, reflecting moderate growth of gasoline consumpti on 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. Pr ices 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 Fede ral programs, including crop insurance, countercyclical payments, marketing loans, and the Average Crop Revenue Election program. Additionally, ethanol imports ar e 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 sila ge in the 2007 Ag ricultural Census were Io wa, Illinois, Nebraska, Minnesota, and Indi ana (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 fr equent moderate water deficit. It is also possible that irrigated co rn-producing areas would be nefit if adoption of MON

87460 would allow reduction of irri gation 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 mois ture 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 w ith most non-irrigated acreage of corn harvested are North Dakota, Colorado, Montana, New Mexico, and Wyoming. States with average annual prec ipitation 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 varia tion of precipitation thro ughout the year (and in between years). Therefore, there would be fewer incentives for adoption of MON 87460 in states with higher averag e annual precipitation. Of the 10 states identified above, all except

Minnesota are in the Great Plains area of corn production, with Mi nnesota 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 a nd Colorado, the share of total irri gated crop acres (not just corn59 

### acres) that had diminished yields due to irriga tion interruption in 2008 was more than a quarter of the total (USDA, 2008).

Most of this section focuse s on the states where MON 87460 a doption 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 th is region have portions wi th 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 in tended to emphasize the potential for regionally differentiated impacts, noting that impacts on othe r 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 th ird-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 grow ing 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 standa rds of varietal purit y. The AOSCA offers a standard for production of non-GE co rn seeds that allows for 1 pe rcent 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 co rn 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 e nvironment, adoption of MON 87460 would be more likely in some geographic areas than in others . Therefore, the domestic economic environment most likely affected by deregul ating MON 87460 would be the area of its adoption. To the extent MON 87460 adoption allows for increas ed 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 pr oduction and corn acreage. Because it is a GE crop, the potential for uninten ded presence in non-GE corn fi elds 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 in crease in corn production due to the decreased yield loss under water-limite d conditions offered by MON 87460 would not be realized. It

should be noted that demand for U.S. corn is projected to remain st rong due mostly to the increases in global demand (exports) and the mainte nance of incentives for use of ethanol.

4.8.1.2 Preferred Alternative : Domestic Economic Environment

Varieties of Drought Tolera nt Corn Available

Deregulating MON 87460 would allow the commercial ization 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. Regi onally marketed conventional traits apparently have similar drought tolerant properties to t hose 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 fo r drought tolerance. A current offering of seed might include 22% of the options with a high drought tolerance rating (f or maturities 79-119) (DeKalb, 2011). Some companies currently offe r 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 de regulating 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 pr oducing 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 ex pected 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 sc enario. The variables assumed in this exercise should not be considered to be those APHIS expects to actu ally occur, but rather reasonable assumptions, given the illustrative purpose of this exercise and curre nt available information.

Assumptions:

1. Yields of conventional varieties are exp ected 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 conditio ns would be 85% of the yield under adequate water conditions).

2. MON 87460 is expected to provide a 6 percent reduction in yi eld losses under those circumstances (Reeves, 2010).61 

### 3. Farmers perceived a 50 percen t chance of water shortages (i.e ., half the pl anted corn is subjected to water-limited conditions and ha lf is under adequate water conditions)

Expected yield returns in corn farmi ng 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 wate r 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) produc tion 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, th en assuming the same ratio or 0.5 = (2.76)/(% increase in net returns), a 2.76 pe rcent increase in yi elds corresponds to 5.5 percent increase in net returns). Available estimates of elasticity of co rn 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 co rn acreage (i.e., percent increase in corn acreage = 0.48 x 5.5 percent increase in net returns) in t hose areas where returns from a doption of MON 87460 are expected to increase. Taking non-irrigate d harvest corn acreage from th e 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 per cent 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 produc tion, rather than from land currently not in62 

### agricultural use (inclu ding CRP land). Because the area s of corn expansion would be presumably areas subject to yield loss under wa ter 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 imp act, given the assumptions. If the number of farms potentially benefiting from MON 87460 adopti on 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 coul d increase in areas that adop t MON 87460. For example, using the same hypothetical scenario described a bove 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 increa se 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 resi dence corn farmers and most of the income of intermediate corn farmers (those with less th an $250,000 in annual farm sales) was from offfarm sources. Only on commercial corn farm s (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 de regulation 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 exte nt of savings in wate r costs that might be stimulated following the adoption of MON 87460. Indeed, the observati ons presented in the petition indicate that expected maximum yield in the variety depend s on attaining sufficient water (Reeves, 2010). MON 87460 would be used to provide a safeguard against unexpected interruptions in water for irrigation, but would cert ainly be used by growers if reducti ons in irrigation proven possible or

that MON87460 was otherwise useful in some circum stances to reduce use of irrigation water. At present, irrigation sparing capacity of MON 87460 has not been demonstrated, and expectations for savings on irriga tion are not consistent with current experimental observations provided by the appli cant (Reeves, 2010).63 

### Additional Impacts

The greatest impact of the produc t will likely be that growers e xperience yield losses with MON 87460 that are less than those incurred by planting non-drought tolerant corn varieties. Another possible impact is the possible re duction of crop insurance costs, since better poten tial yield in drought could be purchased by growers especially if growing MON 87460 might be specifically stipulated by an insurance contract (as for ex ample, a “Biotech Yield Endorsement” that is offered by insurance providers (Io wa State, 2007)). An increase in land values as a result of planting MON 87460 is also possible, although th ere 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 gr own in generally the same areas. Although the unintended presence of GE conten t in organic farming does not n ecessarily 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 8 7460 would be any more likely than gene flow from currently available GE varieties for re asons 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 projecti ons 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 cu rrent 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 wate r-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 fede ral 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 policie s are expected to continue in the foreseeable future and add to the incentive for corn production th at would follow MON 87460 deregulation.

Corn acreage is expected to increase, but conve rsion 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 enrollmen t (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 convers ion of CRP acres would be independent of adoption of MON 87460 corn.

Other Federal policies such as Federal crop insurance, marketi ng loans, direct and countercyclical payments, and the Average Crop Re venue Election (ACRE) program may influence64 

### decisions of planting corn (as opposed to other crops or as opposed to non-agricultural uses of land) and add to the incentiv e for corn production that w ould follow MON 87460 deregulation.

4.8.2 Trade Economic Environment

The U.S. is the largest world e xporter of corn. This section de scribes potential impacts on U.S. trade flows from deregulating of MON 87460.

In the 2008/9 marketing year, corn exports account ed for approximately 15 percent of the total U.S. corn use behind feed, ethanol production, an d 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 th an 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 expor t 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 co arse 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 Ko rea, Mexico, Egypt, and Taiwan (USDA-FAS, 2010b). Between the trade year s (October through September) of 2003/4 thr ough 2007/8, the U.S. share of world corn expor ts averaged 60 per cent, the second la rgest exporter being Argentina, with China’s exports being occasiona lly 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 a pproved 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. Ther e is no restriction afte r 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 vegeta ble oils (USDA-FAS, 2006).

While detailed data are not read ily 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. have65 

### established trade codes for or ganic 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 de fined as those countri es with which the U.S. engages in corn feed, seed and food trade. Therefore, the tr ade economic environment most likely affected by deregulating MON 87460 would be those coun tries who import MON 87460 feed, seed, and

food.

4.8.2.1 No Action: Trade Economic Environment

The USDA provides projections for the agricult ural 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 re main slightly below 60 percent, with U.S. corn exports therefor e increasing at a rate also cl ose to 30 percent. Although, many countries are investing in biofuel production capac ity, several feedstocks are used in addition to corn, such as sugarcane for ethanol and rapes eed 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: Trad e 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 destina tion 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 re gulatory 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 Au stralia and New Zeala nd 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 exte nt this interest translates to demand for U.S. MON 87460 seed as a result of the deregulatio n of MON 87460, there coul d be a potential for increased corn seed exports. Be cause corn seed exports are a sm all 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: Trad e Economic Environment

APHIS identified a potential minor or negligible impact to trade economic environment as a result of the Preferred Alternative, which coul d contribute to a cumulative impact by another foreseeable action. MON 87460 seed may be market ed abroad, potentially stacked with existing corn germplasm that exhibits similar traits; depending upon how much increase in corn production the variety may encourage, there ma y 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. Curren tly, requests for appr ovals for all purposes66 

### 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 tran sboundary 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 Commun ities Affected Environment section, APHIS evaluated the potential for gene flow to occu r from MON 87460 to sexually compatible wild relatives. As stated previously, cultivated corn is sexually comp atible with its closest relative, teosinte, and with members of the genus Tripsacum , although to a much lesser degree (Mangelsdorf, 1974; OECD, 20 03; 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 te osinte 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 (U SDA-NRCS, 2011). Tripsacum species have one less chromosome than corn but can hybridize with corn, although it is very difficult and requires special techni ques, 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 hu man 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 fact ors such as flowering time, geographical separation, and development factors (Doebley, 19 90a, 1990b; Ellstrand, et al., 2007; Galinat, 1988). Further, Tripsacum dactyloides and Tripsacum floridanum would not be aff ected by MON 87460 because of the difficulty of hybridizing with thes e species. The potential impact of gene flow into teosinte is not expected to be any differen t than that of other curr ently available cultivated

corn varieties. Based on these considerat ions, and in particular geographic separation, APHIS anticipates no potential direct, indirect or cumulative trans boundary gene flow impacts into

teosinte found in Mexico.

No known sexually compatible spec ies were identified in Canada, and APHIS has identified no potential direct, indirect or cu mulative 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 na tion. Congress, on be half of the American people, passed the ESA to prevent extinctions fa cing many species of fish, wildlife and plants. The purpose of the ESA is to conserve endangere d 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 c ooperation with the Nati onal Marine Fisheries Service (NMFS), other Federal, State, an d 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 fi rst be added to the Federal lis t of threatened and endangered wildlife and plants.

A species is added to the list when it is de termined by the USFWS/NMFS to be endangered or threatened because of any of the following factors:

 The present or threatened destruction, modi fication, 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 fact ors 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 meas ures include protection fr om adverse effects of

Federal activities.

Section 7 (a)(2) of the ESA requires that Federa l agencies, in consulta tion 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 responsib ility of the Federal agency taking the action to

assess the effects of their action and to consul t with the USFWS and NMFS if it is determined that the action “may affect” listed species or cri tical habitat. This process is used by APHIS to assist the program in fulfilling their obligations and responsibili ties 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 an d, if necessary, the biological assessment. For each transgene(s)/transgenic plant the following in formation, data, and questions are considered by APHIS:

 A review of the biology, taxonomy, and weed iness potential of the crop plant and its sexually compatible relatives;

 Characterization of each transgene with re spect to its structure and function and the nature of the organism from which it was obtained;68 

###  A determination of where the new transgen e 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, a nd agronomic and environmental impact;

 Determination of the concen trations 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 speci es (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 an alyzed by considering the response that TES could have if exposed to MON 87460. Indi rect effects are those that

could result from the use of M ON 87460 in corn produc tion, would occur late r in time, but are still reasonably certai n to occur. Considerat ion is given for the po tential of MON 87460 to change the baseline habitat of TES including cr itical 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 compatib le wild relatives (including threatened or endangered plant species) in the U.S., except fo r 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 characteris tics, and volunteers are easily controlled. It is not capable of estab lishing persistent popul ations in unmanaged environments. As discussed previously, the pres ence of the CSPB protei n 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 thre atened or endangered plant species than conventionally bred corn.

Corn is a feed commonly provided to many live stock 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 characterist ics of the donor organisms, the CSPB and NPTII proteins have a history of safety to organism s 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 su ccessfully completed for CSPB and NPTII proteins of MON 87460 (Appendix A), which demonstrated a lack of toxicity and69 

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

MON 87460 would affect threatened and endangered animal species, incl uding 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 mu ch of the land used will be at the expense of acreage planted to ot her 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 environmentall y 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 wildlif e habitat. By taking land out of production under long term contracts, growers are given annua l 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; McC oy 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 thro ugh 2020, no net increase in c onversion of CRP lands for the reduced yield loss corn will like ly occur. Some acreage may move in and out of CRP lands, but overall, APHIS has evaluated in this EA that neit her 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 redu ce yield loss from drought, and displays no agronomic characteristics substant ially different from existing comm ercial corn, and therefore is not weedy, nor likely to contribut e to weediness of corn. Aside from expression of a common bacterial protein, no differences have been shown from similar corn varie ties. Because no traits

of MON 87460 corn have been shown to be diff erent from commodity corn, it is highly unlikely that MON 87460 will have impacts different from ot her 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 herbic ide 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 re sources 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 sp ecies proposed for listing. As a result, a detailed exposure analysis for individual speci es is not necessary.

APHIS has considered the effect of MON 87460 producti on on designated critical habitat or habitat proposed for designation an d could identify no difference from effects that would occur from the production of other corn varieties. Additi onally, cornfields are not designated critical habitat for any Federally threatened and endangered animal species listed under the ESA (USFWS 2010). As discussed, APHIS has concl uded that the deregulation of this MON 87460 corn is unlikely to lead to large scale conve rsion of CRP land and consequent significant impacts on some CRP land that could become agricultural.70 

### Based on the above informatio n, APHIS has concluded that a determination of nonregulated

status of MON 87460 would have no effect on Federall y listed threatened or endangered species or species proposed for listing, nor would it affect designated cr itical habitat or habitat proposed for designation. Consequently, consultation with the USFWS or NMFS is not required for this action.71 

### 6 CONSIDERATION OF EXECUTIVE O RDERS, STANDARDS, AND TREATIES

RELATING TO ENVIRONMENTAL IMPACTS

6.1.1 Executive Orders with Domestic Implications

The following executive orders require considera tion of the potential impacts of the federal action to various segmen ts of the population.

 Executive Order (EO) 12898 (US-NARA, 2 010), "Federal Actions to Address Environmental Justice in Minority P opulations and Low-Income Populations," requires Federal agencies to conduct thei r programs, policies, and activities that substantially affect human health or the e nvironment 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 preven t 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 mean ingfully greater than in the general population. Geographically di sperse groups with common conditions of environmental exposure may also be considered as a community subj ect to analysis for percentage presence of minority gr oups (e.g. agricultural workers).

Table 8 shows minority presence in the U.S. a nd in the states where MON 87460 would likely be adopted to reduce the potential yield loss from water shortage s. 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 Ne w 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 a nd 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 Latino a Total

Minorities b

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 Latino a Total

Minorities b

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, Ameri can Community Survey 2008 (USCB 2008).

a Individuals who identify themselves as Hisp anic, Latino, or Spanish might be of any race; the sum of the other percentages unde r

the “Percent of Total Population” columns plus the “Hispani c or Latino” column therefore does not equal 100 percent.

b The total minority population, for the purposes of this analysis, is the total populat ion minus the non-Latino/Spanish/Hispanic

white population.

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

Location T otal farme r 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 Agricult ure – State Data (USDA-NASS 2007b)



### To the extent that impacts of MON 87460 deregulation affect prim arily 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 th e highest percentage of Ameri can Indian farmers is in New Mexico at 20.6% (Table 9). Although Hispanic operators are consid erably more highly73 

### represented in the ten state re gion than in the c ountry 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 work ers in the U.S. are born in Mexico

 75 percent in the 2001/02 fiscal year (USDOL-(United-States-Depar tment-of-Labor), 2005). A relatively small share, 14 percent, of all agri cultural workers had a field crop as their primary crop in 2001/02, most agricultural workers being employed in fr uit, vegetable, and hor ticultural crops (USDOL- (United-States-Department-of-Labor), 2005). Ho wever, 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 repres entative household sample. Table 10, below, shows that the share of population in poverty in th e ten state region is only slightly higher than the share of the population in povert y in the country as a whole.

Table 10: Low-income presence, 2008.

Location Total a 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 per cent of the U.S. population was below the U.S. Census Bureau poverty line, while 14 percent of farm households we re poor. Offutt and Gundersen (2005) argue that the U.S. Census Bu reau poverty line might not adequately capture poverty in farm households, given th at it does not capture the volat ility of farm income and the greater asset holdings of farm households. U nder the USDA alternative concept of Limited Resource Farmer, 11 percent of farm households would fall under that category in 2003, while74 

### under the USDA ERS Low Income/Low Wealth c oncept, only 5 percent of farm households would be classified as such in that same year.

The possibility of disproportiona tely high and adverse human heal th 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 ex ample, differential patterns of consumption of water or subsistence consumpti on 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 reso urces, then these differential patterns of consumption could also lead to dispr oportionately high and adverse impacts.

Each alternative was an alyzed with respect to EO 12898. Neither alternative is e xpected to have a disproportionate adverse effect on minorities or low-income populations. As presented in the Environmental Consequences section, no significan t impacts were identified in the analyses conducted on human health, physical environmen t, 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 populati ons who might be exposed to them through agricultural production and/or processing. No additional safe ty precautions would need to be taken.

None of the impacts on agricultura l practices expected to be a ssociated with deregulation of MON 87460 are expected to have a disproportio nate adverse effect on minorities and low income populations. MON 87460 is not genetically engineered to pr oduce a toxin or pesticide, and is not genetically engineered to be tolerant to a herbicide. D ue to the lack of pesticidal and herbicidal tra its in MON 87460, corn hybrid varie ties may be produced with MON 87460 and other nonregulated corn hybrids containing he rbicide tolerant and/or pesticide traits. Thus, pesticide application prac tices and usage associated wi th deregulation of MON 87460 are not expected to change from the current tr ends for existing nonregulated GE corn.

 EO 13045, “Protection of Children from En vironmental 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 patter ns, 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 addr ess environmental hea lth risks and safety risks that may disproporti onately 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 ag ricultural production a nd/or processing. No additional safety precautions would need to be taken.

None of the impacts on agricultura l practices expected to be a ssociated with deregulation of MON 87460 are expected to have a dispr oportionate 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. D ue to the lack of pesticidal a nd herbicidal traits in MON 87460, corn hybrid varieties may be produced with MON 87460 and othe r 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 re sponsibilities regardi ng the introduction and effects of invasive species:

EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal agencies take action to prevent the introductio n of invasive species, to provide for th eir 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 spill ed seed; they do not es tablish self-propagating populations. Corn does not possess tr aits that are characteristic of invasive species (Baker 1965, Keeler 1989, Galinat 1988).

The following executive order requires the pr otection of migratory bird populations:

EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agen cies to Protect Migratory Birds,” states that federal agencies taking actions that have, or are likely to have, a measurable negative e ffect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understanding (MOU) with the Fish and Wi ldlife Service that shall promote the conservation of migrator y 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 allerg enic, 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). Additionall y, 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 E ffects Abroad of Major Federal Actions” requires federal officials to take into consider ation any potential environmental effects outside the U.S., its territories, and possessions th at result from actions being taken.

APHIS has given this EO careful consideration and does not expect a si gnificant environmental impact outside the U.S. in the event of a dete rmination of nonregulated status of MON 87460. All existing national and international regulatory authorities, and phytosanitary regimes that currently apply to intro ductions of new corn cultivars inte rnationally apply equally to those covered by an APHIS determination of nonre gulated status under 7 CFR Part 340.

Any international trade of MON 87460 subsequent to a determina tion of nonregulated status of the product would be fully subject to national p hytosanitary requirements and be in accordance with phytosanitary standards de veloped under the Internationa l 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, 2 010). 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 reci procal acceptance of phytosanitary certification among the nations that have sign ed 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 Meas ure 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 agricu ltural 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 Un ited Nations Convention on Biological Diversity (CBD) that established a fr amework for the safe tr ansboundary movement, with respect to the environment and biodivers ity, of LMOs, which include those modified through biotechnology. The Protocol came into force on Se ptember 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 co untries 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 cons istent 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 databa se on domestic use of LMOs for FFP that may be subject to transbou ndary movement. To f acilitate 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 bioe ngineered products (N BII, 2010). These

data will be available to the Biosafety Clearinghouse.

APHIS continues to work toward harmonizati on of biosafety and bi otechnology consensus documents, guidelines, and regul ations, including with in the North Americ an Plant Protection Organization (NAPPO), which includes Mexi co, 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 Environmen t of Transgenic Plants in NAPPO Member

Countries (NAPPO, 2009).

APHIS also partic ipates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperation on agri cultural biotechnology issues for the U.S., Mexico, and Canada. In addition, bilateral disc ussions on biotechnology regulatory issues are held regularly with other countries including Ar gentina, Brazil, Japan, China, and Korea.

6.1.3 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the changes in corn pr oduction due to the unrestricted use of MON 87460

. Cultivation of MON 87460 is not expected to lead to the in creased production of corn in U.S. agriculture.

There is no expected change in water us e 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 c oncludes that the cu ltivation of MON 87460 would comply with

the Clean Water Act and the Clean Air Act.

6.1.4 Impacts on Unique Characte ristics of Geographic Areas

A determination of nonregulat ed status of MON 87460 is not expected to impact unique characteristics of geographic areas such as pa rk lands, prime farm lands, wetlands, wild and scenic areas, or ecologi cally 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 expect ed 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 destru ction or damage to property; no alterations of prope rty, wildlife habitat, or landscapes ; and no prescribed sale, lease, or transfer of ownership of any property. This action is limited to a determination of78 

### 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, irrigatio n, and harvesting of plants would be used on agricultural lands plante d to MON 87460, including the use of EPA registered pesticides.

6.1.5 National Historic Preservation Ac t (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 cons titute "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 A dvisory Council on Hist oric Preservation (i.e.,

State Historic Preservation Offi ce, Tribal Historic Preservati on Officers), as appropriate.

APHIS’ proposed action, a determination of nonr egulated status of MO N 87460 is not expected to adversely impact cultural resources on tribal properties. Any farmin g activity that may be taken by farmers on tribal lands would only be c onducted at the tribe’s request; thus, the tribes would have control over any poten tial conflict with cultural re sources on tribal properties.

APHIS’ Preferred Alternative would have no impact on districts, sites, hi ghways, structures, or objects listed in or eligible for listing in the Na tional 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 pr otected under the NHPA. In general, common agricultural activ ities conducted under this action do not have the poten tial 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 exam ple, there is potential for increased noise on the use and enjoyment of a historic property durin g 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 M ON 87460 is not expected to change any of these agronomic practices that would result in an adverse impact under the NHPA.79 

### 7 REFERENCES

Aneja, V. P., Schlesinger, W. H., & Erisman, J. W. (2009). Effects of Agriculture upon the Air Quality and

Climate: Research, Policy, and Regulations. Environmental Science & Technology, 43 (12), 4234

‐ 4240.

AOSCA. (2003). AOSCA: 99% Non

‐ GMO Corn Grain Program Requirements. Retrieved March 2011, from http://www.identitypreser ved.com/handbook/aosca

‐ nongmocorn.htm

AOSCA. (2009). Seed Certification Handbook: Including Genetic and Crop Standards, Procedures, and

AOSCA Service Programs.
Bais, H. P., Weir, T. L., Perry, L. G., Gilroy, S., & Vivanco, J. M. (2006). The role of root exudates in rhizosphere interactions with plants and other organisms. Annual Review of Plant Biology, 57 (1),

233

‐ 266.
Baker, H. G. (1965). Characteristics and modes of origin of weeds. In H. G. Baker & G. L. Stebbins (Eds.),

The Genetics of Colonizing Species (pp. 147

‐ 168). Berkeley, CA: Department of Botany,
University of California, Berkeley, USA.
Baker, J. B., Southard, R. J., & Mitchell, J. P. (2005). Agricultural Dust Production in Standard and

Conservation Tillage Systems in the San Joaquin Valley. J. Environ. Qual., 34 (4), 1260

‐ 1269. doi: 10.2134/jeq2003.0348
Barker, T., Campos, H., Cooper, M., Dolan, D., Edmeades, G., Habben, J., Schussler, J., Wright, D., &
Zinselmeier, C. (2005). Improving drought tolerance in maize. In J. Janick (Ed.), Plant Breeding

Reviews (Vol. 25): John Wiley and Sons, Inc

Barr, K. J., Babcock, B. A., Carriquiry, M., Nasser, A., & Harfuch, L. (2010). Agricultural Land Elasticities in

the United States and Brazil. Retrieved from http://ageconsearch.um n.edu/bitstream/58047/2/10

‐ WP_505.pdf
Beasley, J. C., & Rhodes Jr., O. E. (2008). Relationship between raccoon abundance and crop damage.

Human

‐ Wildlife Conflicts, 2 (2), 248

‐ 259.
Benbrook, C. (2009). Crops on Pesticide Use in the United States: The First Thirteen Years. The Organic

Center: Critical Issue Report: The First Thirteen Years

. Retrieved from http://www.organic

‐ center.org/reportfiles/GE13YearsReport.pdf

Bengtsson, J., Ahnström, J., & Weibull, A. (2005). The effects of organic agriculture on biodiversity and

abundance: a meta

‐ analysis. Journal of Applied Ecology, 42 (2), 261

‐ 269.

Best, L. B., & Gionfriddo, J. P. (1991). Characterization of Grit Use by Cornfield Birds. The Wilson Bulletin
by the Wilson Ornithological Society, 103 (1), 68

‐ 82.
Bosnic, A. C., & Swanton, C. J. (1997). Influence of barnyardgrass ( Echinochloa crusgalli ) time of

emergence and density on corn ( Zea mays ). Weed Science, 45 (2), 276

‐ 282.
Boyer, J. S. (1982). Plant productivity and environment. Science, 218 (4571), 443.
Bray, E. A., Bailey

‐ Serres, J., & Weretilnyk, E. (2000). Responses to abiotic stresses. In B. B. Buchanan, W.

Gruissem & R. L. Jones (Eds.), Biochemistry and Molecular Biology of Plants (pp. 1158

‐ 1203).
Rockville, MD: American Society of Plant Physiology.
Brookes, G., & Barfoot, P. (2010). GM crops: global socio

‐ economic and environmental impacts 1996

‐ 2008: PG Economics Ltd, Dorchester, UK.
Brooks, D. R., Bohan, D. A., Champion, G. T., Haughton, A. J., Hawes, C., Heard, M. S., Clark, S. J., Dewar,

A. M., Firbank, L. G., Perry, J. N., Rothery, P., Scott, R. J., Woiwod, I. P., Birchall, C., Skellern, M.

P., Walker, J. H., Baker, P., Bell, D., Browne, E. L., Dewar, A. J. G., Fairfax, C. M., Garner, B. H., Haylock, L. A., Horne, S. L., Hulmes, S. E., Mason, N. S., Norton, L. R., Nuttall, P., Randle, Z.,
Rossall, M. J., Sands, R. J. N., Singer, E. J., & Walker, M. J. (2003). Invertebrate responses to the

management of genetically modified herbicide–tolerant and conventional spring crops. I. Soil

‐80 surface

‐ active invertebrates. Philosophical Transactions of the Royal Society of London. Series B: Biological Sciences, 358 (1439), 1847

‐ 1862.

Bruce, W. B., Edmeades, G. O., & Barker, T. C. (2002). Molecular and physiological approaches to maize
improvement for drought tolerance. Journal of Experimental Botany, 53 (366), 13

‐ 25.
Burzio, L. A., McClain, J. S., & Silvanovich, A. (2008). Bioinformatics evaluation of the CSPB protein utilizing the AD8, TOXIN6 and PROTEIN databases. Monsanto Company.

CBD. (2010). The Cartegena Protocol on Biosafety Retrieved March 30, 2010, from http://www.cbd.int/biosafety/

Cerrato, M. E., & Blackmer, A. M. (1990). Comparison of models for describing corn yield response to nitrogen fertilizer. Agronomy Journal, 82 (1), 138

‐ 143.

CFIA. (1994). The biology of Zea mays (L.) (Maize)

. Plant Biosafety Office Retrieved from http://www.inspection.gc.ca/eng lish/plaveg/bio/dir/dir9411e.pdf

. Chen, M., Zhao, J.

‐ Z., Collins, H. L., Earle, E. D., Cao, J., & Shelton, A. M. (2008). A critical assessment of

the effects of Bt transgenic plants on parasitoids. PLoS One, 3 (5), e2284.
Childs, D. (1996). Top Ten Weeds Retrieved March 2011, from http://www.ppdl.purdu e.edu/ppdl/expert/ Top_Ten_Weeds.html
Christensen, L. A. (2002). Soil, nutrient, and water management systems used in U. S. corn production.
Agriculture Information Bulletin, 774

. Crockett, L. (1977). Wildly successful plants: a handbook of North American weeds : Macmillan.
Dale, V. H. (1997). The Relationship Between Land

‐ Use Change and Climate Change. Ecological
applications, 7 (3), 753

‐ 769.
DeKalb, A. a. (2011). 2011 Seed Resource Guide.
Delisle, J. M., & Savidge, J. A. (1997). Avian use and vegetation characteristics of Conservation Reserve
Program fields. J. Wildl. Manage., 61

, 318

‐ 325. Doebley, J. (1990a). Molecular evidence for gene flow among Zea species. BioScience, 40 (6), 443

‐ 448. Doebley, J. (1990b). Molecular Systematic of Zea (Gramineae). Maydica, 35

, 143

‐ 150.
Dolbeer, R. A. (1990). Ornithology and integrated pest management: red

‐ winged blackbirds Agleaius
phoeniceus and corn. The International Journal of Avian Science, 132

, 309

‐ 322.

EFSA. (2004). Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified Plants.

Scientific Opinion of the Panel on Genetically Modified Organisms (GMO) and the Panel of
Biological Hazards (BIOHAZ). EFSA Journal (4), 1

‐ 18. doi: 10.2903/j.efsa.2004.48
Elbehri, A. (2007). The changing face of the US grain system. Economic Research Report No. ERR

‐ 35,

Economic Research Service, USDA

. Ellstrand, N. C., Garner, L. C., Hegde, S., Guadagnuolo, R., & Blancas, L. (2007). Spontaneous hybridization between maize and teosinte. Journal of Heredity, 98 (2), 183.

EPA. (2005). Protecting Water Quality for Agricultural Runoff. (EPA 841

‐ F

‐ 05

‐ 001).

EPA. (2009). Soil Preparation. Retrieved March 2011, from http://www.epa.gov/agricu lture/ag101/cropsoil.html

EPA. (2010a). Climate change indicators in the United States

. Washington DC: Environmental Protection
Agency Retrieved from http://www.epa.gov/climat echange/indicators/pdfs/ ClimateIndicators_full.pdf

. EPA. (2010b). Inventory of U.S. greenhouse gas emissions and sinks: 1990

‐ 2008 Retrieved March 2011,

from http://www.epa.gov/climatecha nge/emissions/downloads10/US

‐ GHG

‐ Inventory

‐ 2010_Report.pdf

EPA. (2010c). National Ambient Air Quality Standards (NAAQS) Retrieved March 2011, from http://www.epa.gov/air/criteria.html

EPA. (2010b). Basic Information ‐ Air Emission Sources Retrieved March 2011, from http://www.epa.gov/air/emissions/basic.htm81 FAOSTAT. (2008). Food and agricultural commodities production. Retrieved March 2011, from http://faostat.fao.org /site/339/default.aspx

FAPRI. (2004). Documentation of the FAPRI Modeling System. 1

‐ 238. Retrieved from http://www.fapri.missouri.edu/outreach/publ ications/2004/FAPRI_UM C_Report_12_04.pdf
Food, Conservation, and Energy Act of 2008, 110

‐ 246 (2008).

Fausey, J. C., James, J. K., Swinton, S. M., & Renner, K. A. (1997). Giant Foxtail (Setaria faberi)

interference in nonirrigated corn ( Zea mays ). Weed Science, 45 (2), 256

‐ 260.

Faust, M. J. (2002). New feeds from genetically modified plants: the US approach to safety for animals

and the food chain. Livestock Production Science, 74 (3), 239

‐ 254.

Fawcett, R., & Caruana, S. (2001). Better soil, better yields: A guidebook to improving soil organic matter

and infiltration. Retrieved from http://www.ctic.purdue. edu/media/pdf/Better%20Soil%20Better%20Yields.pdf

FDA. (1999). Biotechnology consultation note to the File BNF No. 000052 Retrieved March 2011, from http://www.fda.gov/Food/Biotec hnology/Submissions/ucm155793.htm
Carbohydrase and protease enzyme preparations derived from Bacillus subtilis or Bacillus amyloliquefaciens ; affirmation of GRAS status as direct food ingredients (1999b).

FDA. (2010). List of Completed Consultations on Bioengineered Foods. United States Food and Drug
Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland, January
2011, from http://www.fda.gov/Food/Biotech nology/Submissions/default.htm

Fernandez

‐ Cornejo, J., Nehring, R., Sinha, E. N., Grube, A., & Vialou, A. (2009). Assessing recent trends in pesticide use in U. S. agriculture

. Paper presented at the Meeting of the AAEA, Milwaukee, WI. http://ageconsearch.umn.e du/bitstream/49271/2/Fernandez

‐ Cornejo%20et%20al%20%20

‐ %20AAEA%202009%20

‐ %20Selected%20Paper%20

‐ %20%20April%2019.pdf

Ferris, J., & Siikämaki, J. (2009). Conservation Reserve Program and Wetland Reserve Program: Primary

land retirement programs for promoting farmland conservation Backgrounder (pp. 1

‐ 33).
Washington, D.C.: Resources for the Future. Flachowsky, G., Chesson, A., & Aulrich, K. (2005). Animal nutrition with feeds from genetically modified
plants. Archives of Animal Nutrition, 59 (1), 1

‐ 40.
Fuchs, R. L., Heeren, R. A., Gustafson, M. E., Rogan, G. J., Bartnicki, D. E., Leimgruber, R. M., Finn, R. F.,
Hershman, A., & Berberich, S. A. (1993a). Purification and Characterization of Microbially
Expressed Neomycin Phosphotransferase II (NPTII) Protein and its Equivalence to the Plant
Expressed Protein. Nature Biotechnology, 11 (12), 1537

‐ 1542.
Fuchs, R. L., Ream, J. E., Hammond, B. G., Naylor, M. W., Leimgruber, R. M., & Berberich, S. A. (1993b).
Safety Assessment of the Neomycin Phosphotransferase II (NPTII) Protein. Nature Biotechnology, 11 (12), 1543

‐ 1547.
Galinat, W. (1988). The origin of corn. In G. F. Sprague & J. W. Dudley (Eds.), Corn and Corn Improvement (pp. 1

‐ 27). Madison, WI: American Society of Agronomy, Inc., Crop Soil Science Society of

America, Inc., and the Soil Science Society of America, Inc.

GAO. (2001). Chemical risk assessment: Selected Federal agencies' procedures, assumptions, and
policies. United States General Accounting Office Report to Congressional Requesters. August

2001. GAO

‐ 01

‐ 810.

. [Report].

Giannessi, L. P. (2005). Economic and herbicide use impacts of glyphosate

‐ resistant crops. Pest
Management Science, 61

, 241

‐ 245.
Giles, D., Downey, D., & Thompson, J. (2006). In Field Assessments of Dust Generation of Harvesting
Equipment. Retrieved from http://www.ncsu.edu/airworkshop/Emissions_Crop.pdf
Gould, F. (1968). Grass Systematics

. New York, New York: McGraw Hill, NJ.82 Greene, C., Dimitri, C., Lin, B.

‐ H., McBride, W., Oberholter, L., & Smith, T. (2009). Emerging issues in the

U.S. organic industry. Economic Information Bulletin Number 55

. Retrieved from http://www.ers.usda.gov/ publications/eib55/eib55.pdf

Greuere, G. P. (2006). An analysis of trade related international regulations of genetically modified food

and their effects on developing countries. Retrieved from http://www.ifpri.org/publication/analysis

‐ trade

‐ related

‐ international

‐ regulations

‐ genetically

‐ modified

‐ food

‐ and

‐ their

‐ eff
Griffiths, B. S., Caul, S., Thompson, J., Birch, A. N. E., Cortet, J., Andersen, M. N., & Krogh, P. H. (2007a).

Microbial and microfaunal community structure in cropping systems with genetically modified
plants. Pedobiologia, 51 (3), 195

‐ 206.
Griffiths, B. S., Heckmann, L. H., Caul, S., Thompson, J., Scrimgeour, C., & Krogh, P. H. (2007b). Varietal

effects of eight paired lines of transgenic Bt maize and near

‐ isogenic non

‐ Bt maize on soil

microbial and nematode community structure. Plant Biotechnology Journal, 5 (1), 60

‐ 68.
Hall, M. R., Swanton, C. J., & Anderson, G. W. (1992). The Critical Period of Weed Control in Grain Corn ( Zea mays ). Weed Science, 40 (3), 441

‐ 447.
Hall, R. C., & Twidwell, E. K. (2002). Effects of drought stress on corn production. Retrieved from http://www.sdstate.edu/sdce s/store/Publications/pub

‐ details.cfm?customel_datapageid_858688=872114

Hart, C. E. (2006). Feeding the Ethanol Boom: Where will the Corn come from? Iowa Agricultural Review,

12

, 3

‐ 5. Haughton, A. J., Champion, G. T., Hawes, C., Heard, M. S., Brooks, D. R., Bohan, D. A., Clark, S. J., Dewar,

A. M., Firbank, L. G., Osborne, J. L., Perry, J. N., Rothery, P., Roy, D. B., Scott, R. J., Woiwod, I. P.,
Birchall, C., Skellern, M. P., Walker, J. H., Baker, P., Browne, E. L., Dewar, A. J. G., Garner, B. H., Haylock, L. A., Horne, S. L., Mason, N. S., Sands, R. J. N., & Walker, M. J. (2003). Invertebrate

responses to the management of genetically modified herbicide–tolerant and conventional
spring crops. II. Within

‐ field epigeal and aerial arthropods. Philosophical Transactions of the
Royal Society of London. Series B: Biological Sciences, 358 (1439), 1863

‐ 1877.

Hawes, C., Haughton, A. J., Osborne, J. L., Roy, D. B., Clark, S. J., Perry, J. N., Rothery, P., Bohan, D. A.,
Brooks, D. R., Champion, G. T., Dewar, A. M., Heard, M. S., Woiwod, I. P., Daniels, R. E., Young,

M. W., Parish, A. M., Scott, R. J., Firbank, L. G., & Squire, G. R. (2003). Responses of plants and

invertebrate trophic groups to contrasting herbicide regimes in the Farm Scale Evaluations of
genetically modified herbicide–tolerant crops. Philosophical Transactions of the Royal Society of

London. Series B: Biological Sciences, 358 (1439), 1899

‐ 1913.
Heap, I. M. (2008). International Survey of Herbicide Resistant Weeds.

. Accessed March, 1

, 2008.

Retrieved from www.weedscience.com

. Henry, C., Morgan, D., Weekes, R., Daniels, R., & Boffey, C. (2003). Farm scale evaluations of GM crops: monitoring gene flow from GM crops to non

‐ GM equivalent crops in the vicinity (contract

reference EPG 1/5/138). Part I: Forage Maize.: DEFRA. Utilizing Drought

‐ Damaged Corn

, 1

‐ 4 (1990).
Hoeft, R., Nafziger, E., Johnson, R., & Aldrich, S. (2000). Modern corn and soybean production. Savoy, IL:

MCSP Publications.
Holm, L., Pancho, J., Herberger, V., & Plucknett, D. L. (1979). A geographical atlas of world weeds. 471

‐ 04393.
Holmén, B., Miller, D., Hiscox, A., Yang, W., Wang, J., Sammis, T., & Bottoms, R. (2006). Aerosol Emissions from Field Planting Operations

. Howell, T. A., Tolk, J. A., Schneider, A. D., & Evett, S. R. (1998). Evapotranspiration, yield, and water use efficiency of corn hybrids differing in maturity. Agronomy Journal, 90 (1), 3

‐ 9.83 IPPC. (2010). Official web site for the International Plant Protection Convention: International
Phytosanitary Portal Retrieved March 30, 2010, from https:// www.ippc.int/IPP/En/default.jsp

IPPC (Ed.). (2007). Climate Change 2007; The Physical Science : Cambridge University Press.
Ireland, D., Wilson Jr, D., Westgate, M., Burris, J., & Lauer, M. (2006). Managing reproductive isolation in hybrid seed corn production. Crop Science, 46 (4), 1445.
Johnson, D. H. (2000). Grassland bird use of Conservation Reserve Program Fields in the Great Plains. In

W. L. Hohman & D. J. Halloum (Eds.), A Comprehensive Review of Farm Bill Contributions to Wildlife Conservation, 1985

‐ 2000 (pp. 19

‐ 34).
Keeler, K. H. (1989). Can genetically engineered crops become weeds? Biotechnology, 7 (11), 1134

‐ 1139. Kegley, S. E., Hill, B. R., Orme, S., & Choi, A. H. (2010). PAN Pesticide Database Retrieved March 2011,

from http://www.pesticideinfo.org/
Kermicle, J., & Evans, M. ( 2010). The Zea mays sexual compatibility gene ga2: naturally occurring alleles,

their distribution, and role in reproductive isolation. Journal of Heredity, 101

, 737

‐ 749.
Koele, B. (2008). Wildlife Damage Abatement and Claims Program, 2008. Retrieved from http://dnr.wi.gov/org/land/w ildlife/damage/progreport.pdf

Krueger, J. E. (2007). If your farm is organic, must it be GMO

‐ free?

. Retrieved from http://www.flaginc.org/topics/ pubs/arts/Organi csAndGMOs2007.pdf

Krupa, S., Booker, F., Bowersox, V., & Grantz, D. (2006). Uncertainties in the Current Knowledge of
Atmospheric Trace Gases Associated with Cropping Systems in the US

. Kuepper, G. (2002). Organic field corn production. National Sustainable Agricultural Information

Service.

. Retrieved from http://attra.ncat.org/attra

‐ pub/PDF/fieldcorn.pdf

Kuepper, G., Born, H., & Gegner, L. (2007). Organic System Plan (OSP) Templates for Certifiers

Retrieved from http://attra.ncat.org/attra

‐ pub/PDF/OSPtemplates.pdf

KyCGA. (2011). Feed Corn and distiller's grains promotion Retrieved March 2011
Lal, R., & Bruce, J. (1999). The potential of world cropland soils to sequester C and mitigate the
greenhouse effect. Environmental Science & Policy, 2 (2), 177

‐ 185.
Levine, E. (1991). Management of Diabroticite Rootworms in Corn. Annual Review of Entomology, 36

, 229

‐ 255.

Lew, A. (2004). GEOGRAPHY: USA Retrieved Aug. 18, 2010, from http://www.geog.nau.edu/courses/a lew/ggr346/text/chapters/ch8.html
Mangelsdorf, P. C. (1974). Corn: Its origin, evolution, and improvement : Harvard University Press Cambridge, MA.
Marshall, E. J. P., Brown, V. K., Boatman, N. D., Lutman, P. J. W., Squire, G. R., & Ward, L. K. (2003). The

role of weeds in supporting biological diversity within crop fields. Weed Research, 43 (2), 77

‐ 89.
Marvier, M., McCreedy, C., Regetz, J., & Kareiva, P. (2007). A meta

‐ analysis of effects of Bt cotton and

maize on nontarget invertebrates. Science, 316 (5830), 1475

‐ 1477.
McBride, W. (2005). Farm Income Less Important to Most Corn Farm Households. Retrieved from http://www.ers.usda.gov/AmberWaves/Fe bruary05/Findings/FarmIncomeLess.htm

McCoy, T. D., Ryan, M. R., Burger L.W., J., & Kurzejeski, E. W. (2001). Grassland bird conservation: CP1

vs. CP2 plantings in Conservation Reserve Program fields in Missouri. American Midland
Naturalist, 145 (1), 1

‐ 17.
McWilliams, D. (2002). Drought Strategies for Corn and Grain Sorghum Retrieved March 2011, from http://cahedev.nmsu.edu/pubs/_circulars/CR

‐ 580.pdf

Messmer, R., Fracheboud, Y., Bänziger, M., Vargas, M., Stamp, P., & Ribaut, J.

‐ M. (2009). Drought stress

and tropical maize: QTL

‐ by

‐ environment interactions and stability of QTLs across environments

for yield components and secondary traits. TAG Theoretical and Applied Genetics, 119 (5), 913

‐ 930. doi: 10.1007/s00122

‐ 009

‐ 1099

‐ x84 Morris, M., & Hill, A. (1998). Overview of the world maize economy. Maize Seed Industries in Developing

Countries

, 13

‐ 33. Retrieved from
Muenscher, W. (1980). Weeds, Reprinted: Cornell University Press, Ithaca, New York.

Nap, J.

‐ P., Bijvoet, J., & Stiekema, W. (1992). Biosafety of kanamycin

‐ resistant transgenic plants.
Transgenic Research, 1 (6), 239

‐ 249.

NAPPO. (2009). NAPPO approved standards Retrieved April 22, 2010, from http://www.nappo.org/Standards/Std

‐ e.html

NBII. (2010). United States Regulatory Agencies Unified Biotechnology Website Retrieved March 30,
2010, from http://usbiotechreg.nbii.gov/

NCAT. (2003). NCAT's organic crops workbook: a guide to sustainable and allowed practices. Retrieved

from http://attra.ncat.org/attra

‐ pub/PDF/cropsworkbook.pdf

NCGA. (2007). Corn, Ethanol, and Water Resources Retrieved Febraury 2011, from http://www.iowarfa.org/documents/WaterNCGA.pdf

NCGA. (2010). The World of Corn Retrieved February 2011, from http://www.WorldOfCorn.com

. Neild, R. E., & Newman, J. E. (1990). Growing Season Characteristics and Requirements in the Corn Belt.

In R. F. Dale, D. G. Hanway, R. E. Carlson, G. O. Benson, R. E. Felch, C. M. Sakamoto, E. A. Runge,

R. M. Castleberry, M. W. Seeley, R. H. Shaw, D. R. Hicks & R. L. Nielsen (Eds.), National Corn Belt

. Neilsen, B. (1995). Symptoms of deer corn damage Retrieved March 2011, from http://www.ppdl.purdue. edu/PPDL/weeklypics/1

‐ 10

‐ 05.html

NOAA. (2010). Total Precipitation in Inches by Month. Climatology by State based on Climate Division

Data: 1971

‐ 2000. Retrieved March 2011, from http://www.esrl.noaa.gov/psd/data /usclimate/pcp.state.19712000.climo

Non

‐ GMO

‐ Project. (2010). Non

‐ GMO Project Retrieved July 31, 2010, from http://www.nongmoproject.org/

NRC. (2004). Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health

Effects. The National Academies Press:Washington, D.C.

NRC. (2010). Impact of Genetically Engineered Crops on Farm Sustainability in the United States. The

National Academies Press:Washington, DC.

NRCS. (2011). National Resources Inventory Retrieved March 2011, from http://www.nrcs.usda. gov/technical/NRI/

OECD. (2003). Consensus document on the biology of Zea mays subsp. mays (maize). Retrieved from http://www.oecd.org/officialdo cuments/displaydocumentpdf/?cote=ENV/JM/MONO(2003)11&
doclanguage=en
Olson, R. A., & Sander, D. H. (1988). Corn Production. In G. F. Sprague & J. W. Dudley (Eds.), Corn and

Corn Improvement (pp. 639

‐ 686): American Society of Agronomy

‐ Crop Science Society of

America

‐ Soil Science Society of America.

OTA. (2010). Industry Statistics and Projected Growth Retrieved February 2011, from http://www.ota.com/orga nic/mt/business.html

Patterson, M. P., & Best, L. B. (1996). Bird abundance and nesting success in Iowa CRP fields: The
importance of vegetation structure and composition. American Midland Naturalist, 135 (1), 153

‐ 167.
Pilcher, C. D., Rice, M. E., & Obrycki, J. J. (2005). Impact of transgenic Bacillus thuringiensis corn and crop phenology on five nontarget arthropods. Environmental Entomology, 34 (5), 1302

‐ 1316.

Pioneer

‐ Hi

‐ Bred. (2010). Pioneer Research to Develop Drought Tolerant Corn Hybrids, from http://www.pioneer.com/CMRoot/pioneer/us/ag ronomy/agronomy_research_summary/2010/l ow_water_environments/2010_dro ught_tolerant_corn_hybrids.pdf

Pioneer

‐ Hi

‐ Bred. (2011a, March 9, 2011). Introducing Optimum Aquamax Hybrids Retrieved 3

‐ 9

‐ 11,

from85 http://www.pioneer.com/CMRoot/pioneer/us/pr oducts/seed_trait_technology/optimum_aqua max/aquamax_product_info_brochure.pdf

Pioneer

‐ Hi

‐ Bred. (2011b). Optimum AQUAmax hybrids, from http://www.pioneer.com/home/site/us/products/corn/seed

‐ traits

‐ technologies

‐ corn/optimum

‐

aquamax

‐ hybrids/
Ponsard, S., Gutierrez, A. P., & Mills, N. J. (2002). Effect of Bt

‐ toxin (Cry1Ac) in transgenic cotton on the

adult longevity of four Heteropteran predators. Environmental Entomology, 31

, 1197

‐ 1205.

Reeves, W. R. (2010). Petition for the Determination of Non

‐ Regulated Status for MON 87460

. The

Monsanto Company, St. Louis MO.
Riddle, J. A. (2004). Best management practices for producers of GMO and non

‐ GMO crops. Romeis, J., Meissle, M., & Bigler, F. (2006). Transgenic crops expressing Bacillus thuringiensis toxins and
biological control. Nature Biotechnology, 24 (1), 63

‐ 71.
Rosenzweig, C., Iglesias, A., Yang, X. B., Epstein, P. R., & Chivian, E. (2001). Climate change and extreme

weather events: Implications for food production, plant diseases, and pests. Global Change and

Human Health, 2 (2), 90

‐ 104. doi: 10.1023/a:1015086831467

Rosenzweig, C., & Parry, M. L. (1994). Potential impact of climate change on world food supply. Nature,

367 (6459), 133

‐ 138.
Roy, D. B., Bohan, D. A., Haughton, A. J., Hill, M. O., Osborne, J. L., Clark, S. J., Perry, J. N., Rothery, P.,
Scott, R. J., Brooks, D. R., Champion, G. T., Hawes, C., Heard, M. S., & Firbank, L. G. Invertebrates

and vegetation of field margins adjacent to crops subject to contrasting herbicide regimes in the

Farm Scale Evaluations of genetically modified herbicide

‐ tolerant crops. Philosophical

Transactions of the Royal Society of London. Series B: Biological Sciences, 358 (1439), 1879

‐ 1898.
Russell, W. A., & Hallauer, A. R. (1980). Corn. In W. R. Fehr & H. H. Hadley (Eds.), Hybridization of crop plants (pp. 302). Madison, WI: American Society of Agronomy and Crop Science Society of

America.
Ruth, L. (2003). Tailoring thresholds for GMO testing. Analytical chemistry, 75 (17), 392

‐ 396.
Sanvido, O., Widmer, F., Winzeler, M., Streit, B., Szerencsits, E., & Bigler, F. (2008). Definition and feasibility of isolation distances for transgenic maize cultivation. Transgenic research, 17 (3), 317

‐ 335.
Schmidhuber, J., & Tubiello, F. N. (2007). Global food security under climate change. Proceedings of the

National Academy of Sciences, 104 (50), 19703

‐ 19708. Smedley, J. W. (2008). An acute toxicity study of cold shock protein B administered by the oral (gavage)

route to mice. Retrieved CRO

‐ 2007

‐ 182
Smika, D., & Wicks, G. (1968). Soil water storage during fallow in the Central Great Plains as influenced
by tillage and herbicide treatments. Soil Science Society of America Journal, 32 (4), 591.
Smith, D. R., & White, D. G. (1988). Diseases of Corn. In G. F. Sprague & J. W. Dudley (Eds.), Corn and

Corn Improvement (pp. 687

‐ 749). Madison, WI: American Society of Agronomy.
Smith, J. (2005). Small Mammals and Agriculture ‐ A study of Effects and Responses. http://www.stolaf.edu/depts/environmental

‐ studies/courses/es

‐ 399%20home/es

‐ 399

‐ 05/Projects/Jared's%20Senior%20Seminar%20Res earch%20Page/specieshmousespeciessqch.ht

m

. Last accessed March 2011. Retrieved March, 2011, from http://www.stolaf.edu/depts/environmental

‐ studies/courses/es

‐ 399%20home/es

‐ 399

‐ 05/Projects/Jared's%20Senior%20Sem inar%20Research%20Page/index.htm
Smith, J. W. (2005). Small Mammals and Agriculture ‐ A study of Effects and Responses Retrieved March

2011, from http://www.stolaf.edu/depts/environmental

‐ studies/courses/es

‐ 399%20home/es

‐ 399

‐ 05/Projects/Jared's%20Senior%20Sem inar%20Research%20Page/index.htm
Southwood, T. R. E., & Way, M. J. (1970). Ecological background to pest management Concepts of Pest
Management (pp. 7

‐ 28). Raleigh: N.C. State University.86 Stallman, H. R., & Best, L. B. (1996). Small

‐ mammal use of an experimental strip intercropping system in

northeastern Iowa. American Midland Naturalist, 135 (2), 266

‐ 273.

Sterner, R. T., Petersen, B. E., Gaddis, S. E., Tope, K. L., & Poss, D. J. (2003). Impacts of small mammals

and birds on low

‐ tillage, dryland crops. Crop Protection, 22 (4), 595

‐ 602.
Stockton, M., Wilson, R., & Colburn, F. (2007). Continuous Corn or a Corn/Soybean Rotation? : University

of Nebraska ‐ Lincoln Extension, Institute of Agricultureand Natural Resources.
Sundstrom, F., Williams, J., Van Deynze, A., & Bradford, K. (2002). Identity preservation of agricultural

commodities : ANR Publications.
Tanaka, D. J., & Aase, J. (1987). Fallow method influences on soil water and precipitation storage efficiency. Soil and Tillage Research, 9 (4), 307

‐ 316.

Torres, J. B., & Ruberson, J. R. (2005). Canopy ‐ and Ground

‐ Dwelling Predatory Arthropods in

Commercial Bt and non

‐ Bt Cotton Fields: Patterns and Mechanisms. Environmental entomology,

34 (5), 1242

‐ 1256. doi: 10.1603/0046

‐ 225x(2005)034[1242:cagpai]2.0.co;2

Tu, H. (2009). Updated bioinforamtic evaluation of the NPTII protein utilising the AD_2009 and
TOX_2009 databases.

US

‐ NARA. (2010). Executive Orders disposition tables index Retrieved March 11, 2010, from http://www.archives.gov/federal

‐ register/executive

‐ orders/disposition.html

USCB. (2011). Per Capita Consumption of Major Food Commodities, 1980 ‐ 2008. The 2011 Statistical

Abstract Retrieved March 2011, from http://www.census.gov /compendia/statab/

USDA

‐ APHIS. (2010). Plant Pest Risk Assessment for MON 87460 Corn. (B. R. Service, Trans.). Riverdale,

MD: APHIS ‐ Animal and Plant Health Inspection Service.

USDA

‐ ERS. (2010a). Adoption of Genetically Engineered Crops in the U.S.: Corn Varieties Retrieved Aug.

11 2010, from http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable1.htm

USDA

‐ ERS. (2010b). Agricultural Projections to 2019.

USDA

‐ ERS. (2010c). NEW Feed Grains Data: Yearbook Tables, Corn: Food, seed, and industrial use
Retrieved March 2011, from http://www.ers.usda.gov/data/FeedGrains/Table.asp?t=31

USDA

‐ ERS. (2010d). Organic Production Retrieved February 2011, from http://www.ers.usda.gov/Data/Organic/

USDA

‐ ERS. (2010e). USDA Feed Grain Baseline, 2010

‐ 19 Retrieved January 2011, from http://www.ers.usda.gov/bri efing/corn/2010baseline.htm

USDA

‐ ERS. (2011a). Organic agriculture: Organic trade Retrieved March 2011, from http://www.ers.usda.gov/bri efing/organic/trade.htm

USDA

‐ ERS. (2011b). USDA Agricultural Projections to 2020.

USDA

‐ FAS. (2006). Egypt. Biotechnology. Annual Agricultural Biotechnology Report 2006 Retrieved Aug.
22, 2010, from http://www.fas.usda.gov/gainfiles/200607/146208389.pdf

USDA

‐ FAS. (2008). Republic of Korea Agricultural Biotechnology Report 2008. Retrieved Aug. 22, 2010,

from http://www.fas.usda.gov/gainfiles/200807/146295192.pdf

USDA

‐ FAS. (2008b). Mexico Biotechnology. GAIN Report., Aug. 22, 2010, from http://www.fas.usda.gov/gainfiles/200807/146295179.pdf

USDA

‐ FAS. (2008c). Taiwan Biotechnology, Annual 2008. GAIN Report. (Aug. 22, 2010). Retrieved from http://www.fas.usda.gov/gainfiles/200810/146306245.pdf

USDA

‐ FAS. (2010a). Global Agricultural Trade System Online. Retrieved Aug. 21, 2010, from http://www.fas.usda.gov/gats/default.aspx

USDA

‐ FAS. (2010b). Grain: World Markets and Trade Retrieved Aug. 21, 2010, from http://www.fas.usda.gov/grain/circular/2010/08

‐ 10/grainfull08

‐ 10.pdf

USDA

‐ FAS. (2011). U.S. organic exports continue to expand Retrieved March 2011, from http://www.fas.usda.gov/htp/organics/1

‐ 6

‐ 11%20Organics%20Summary.pdf87 USDA

‐ NASS. (2006). Agricultural Chemical Usage 2005 Field Crops Summary. : United States Department

of Agriculture ‐ National Agricultural Statistics Service Retrieved from http://usda.mannlib.cornell.edu/usda/n ass/AgriChemUsFC//2000s/2006/AgriChemUsFC

‐ 05

‐ 17

‐ 2006.pdf

. USDA

‐ NASS. (2007). Irrigated Corn for Grain, Harvested Acres: 2007. Retrieved Aug. 16, 2010, from http://www.nass.usda.gov/research/2007mapgalle ry/album/Crops_and_Plants/Field_Crops_Ha rvested/slides/Irrigated%20Corn%20for %20Grain,%20Harvested%20Acres.html

USDA

‐ NASS. (2010a). Crop Production 2009 Summary Retrieved Aug. 16, 2010, from http://usda.mannlib.cornell.edu/usda/current/CropProdSu/CropProdSu

‐ 01

‐ 12

‐ 2010.pdf

USDA

‐ NASS. (2010b). National Statistics for Corn Retrieved February 2011, from http://www.nass.usda.gov/Statistic s_by_Subject/result.php?DAC4CC74

‐ 2AC5

‐ 3CB0

‐ B975

‐ 89BE9E64EAF8§or=CROPS&g roup=FIELD%20CROPS&comm=CORN

USDA

‐ NRCS. (2010). Zea mexicana. The PLANTS Database

USDA

‐ NRCS. (2011). Zea perrenis. The PLANTS Database

USDA. (2008). Farm and Ranch Irrigation Survey. 2007 Census of Agriculture. Retrieved Aug. 23, 2010,

from http://www.agcensus.usda.gov/ Publications/2007/Online_Highlig hts/Farm_and_Ranch_Irrigatio n_Survey/fris08.txt

USDA. (2009). 2007 Census of Agriculture: United States Summary and State Data

. USDOL

‐ (United

‐ States

‐ Department

‐ of

‐ Labor). (2005). A Demographic and Employment Profile of United

States Farm Workers.

. National Agricultural Workers Survey (NAWS) 2001

‐ 2002

. USGC. (2006). Value Enhanced Corn Report 2005/2006: U.S. Grains Council.

USGC. (2008). Corn Retrieved February 2011, from http://www.grains.org/corn

. Vercauteren, K. C., & Hygnstrom, S. E. (1993). White

‐ tailed deer home range characteristics and impacts

relative to field corn damage. Paper presented at the Great Plains Wildlife Damage Control
Workshop Proceedings, University of Nebraska ‐ Lincoln.
Vogel, J., Majewski, M., & Capel, P. (2008). Pesticides in rain in four agricultural watersheds in the

United States. Journal of environmental quality, 37 (3), 1101.
Weber, N. (2009). Petition for the Determination of Nonregulated Satus for Maize 32138 SPT Maintainer

Used in the Pioneer Seed Production Technology (SPT) Process

. Johnston, IA: Pioneer Hi

‐ Bred
International, Inc.
Weber, W. E., Bringezu, T., Broer, I., Eder, J., & Holz, F. (2007). Coexistence Between GM and Non

‐ GM

Maize Crops

– Tested in 2004 at the Field Scale Level (Erprobungsanbau 2004). Journal of

Agronomy and Crop Science, 193 (2), 79

‐ 92.

Westcott, P. (2007). US ethanol expansion driving changes throughout the agricultural sector. Amber

Waves, 5 (4), 10

‐ 15.
Westgate, M. E., Otegui, M. E., & Andrade, F. H. (2004). Physiology of the corn plant. In C. W. Smith, J.

Betran & E. C. A. Runge (Eds.), Corn: Origin, History, Technology, and Production

. Hoboken, NJ:

John Wiley and Sons.
Wilkes, H. (1967). Teosinte: the closest relative of maize. Bussey Inst., Harvard Univ., Cambridge

. Wolfenbarger, L., Naranjo, S., Lundgren, J., Bitzer, R., & Watrud, L. (2008). Bt Crop Effects on Functional

Guilds of Non

‐ Target Arthropods: A Meta

‐ Analysis. PLoS One, 3 (5), e2118.

Yu and Babcock, B. (2010). Are U.S. Corn and Soybeans Becoming more Drought Tolerant? Staff General

Research Papers : Iowa State University. Zapiola, M. L., Campbell, C. K., Butler, M. D., & Mallory

‐ Smith, C. A. (2008). Escape and establishment of
transgenic glyphosate

‐ resistant creeping bentgrass Agrostis stolonifera in Oregon, USA: a 4

‐ year study. Journal of Applied Ecology, 45 (2), 486

‐ 494.88 

### 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 documents89 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 engineering90 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

assessment91 

### APPENDIX A. FDA BIOTECHNOLOGY CO NSULTATION 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 Biotech nology Notification File (BNF) No. 000116. In a submission dated December 19, 2008, the Monsan to Company (Monsanto) submitted a safety and nutritional assessment of the bioengineered corn M ON 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 no t intend to restate the information provided in the final consultation in its entirety.

Intended EffectsThe 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 selectabl e 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 uninten tionally adulterated the food with respect to the Federal Food, Drug and Co smetic Act (FFDCA).

Genetic Modification and Characterization Parental Variety Monsanto transformed the recipient LH59 (a non-transg enic 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 transf orming vector carried a transfer DNA sequence comprised of both cspB and nptII expression cassettes. Following transformation, the corn tissue was92 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) an alyses to demonstrate that corn event MON 87460 has one intact copy of the transfer DNA regi on 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 seque ncing to verify the integrity of the integrated cspB and nptII genes along with their associated regulatory elemen ts. 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 de monstrate 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 acro ss multiple generations of corn event MON 87460 to

demonstrate the stable Mendelian inheritance of th e transfer DNA region containing both the cspB and the nptII cassettes.

Monsanto assessed the inserted DNA se quence for any potential unintended open reading frames (ORFs) that might encode proteins. Monsanto identified sev eral 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 sta ndard 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 hypoth esized 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 prot ein as being a selectable marker used in the development of corn event MON 87460. NPTII phosphor ylates neomycin and related antibiotics, thus inactivating them.

Monsanto estimated the levels of CSPB and NPT II 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 c onstruct of the transferred DNA, both CSPB and NPTII proteins would be expected to be present in all tissu es. 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 ma ture 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 bot h 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 applicati ons, Monsanto cited several published studies as well as93 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 a nd plant sources present in the human diet. Using the CSPB protein sequence, Monsanto performed bioinfor matic 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 (s ingle dose of 4.7 milligrams/kilogram) using E. coliproduced CSPB protein. Monsanto noted no treatment-re lated adverse effects. Given the totality of the evidence, Monsanto concluded that the CSPB protei n from corn event MON 87460 is unlikely to exhibit toxic effects when incorpor ated 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 re viewing NPTII, FDA concluded that NPTII does not have any properties that would distinguish it toxico logically 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 exhib it toxic effects when consumed in food or feed.

Assessment of the Potential for Alle rgenicity 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 signifi cant homology to known allergens. For the CSPB protein, in vitro gastric and intestinal diges tibility studies using standard methods did not identify significant resistance to proteolysi s. For the NPTII protein, Monsanto cites an FDA draft guidance document to support its conclusion that the NPTII protei n poses no allergenic risk [Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transg enic Plants (Draft Guidance, issued September 4, 1998)]. In this draft guidance, FDA states that N PTII protein is known to be rapidly degraded under simulated gastric conditions, is neither glycosylat ed nor heat-resistant and lacks homology to known food allergens using several databases. FDA conclud es 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. Co rn grain is used in food primarily in the form of processed products, such as high fructose corn syrup, cereal s, oil, meal, flour, starch, and grits. Corn is a source of nutritionally important amino acids (methioni ne and cystine), carotenoids, and vitamin E. Corn oil is rich in polyunsaturated fatty acids and is u sed mainly as a salad and co oking oil and in margarine production.

Corn is also used in animal feed. Corn grain is prim arily 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 MON94 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 co mposition of forage and grain from MON 87460, its comparator control line, and from a total of ei ghteen 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 commerc ial non-transgenic corn varieties grown under water-limited or irrigation conditions.

Monsanto used the data derived from the reference va rieties to generate a 99% tolerance1 interval for each component. Monsanto states that these data illust rate 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 recei ving 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 conven tional commercial hybrid lines from a single block. Samples of forage at the early dent plant growth stat e 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 gr ain. Compositional analyses of the forage samples included measurement of moisture, crude fat, cr ude 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 moistu re, crude fat, crude protein, ash, carbohydrates by calculation, ADF, NDF, total dietary fiber (TDF), am ino acids (18), fatty acids (C8-C22), minerals (calcium, copper, iron, magnesium, manganese, phos phorus, potassium, sodium, and zinc), vitamins (vitamin B1, vitamin B2, vitamin B6, vitamin E, ni acin, 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 s ites are well-suited to growing corn, but typically do not receive any rainfall so crops receive water only th rough controlled irrigation. Monsanto planted corn event MON 87460, the comparator control line, and f our unique commercial conventional hybrid corn lines per site, providing a total of 16 commercial references for com positional 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 opt imal growth using irriga tion or water-limited to impose a drought stress during a critical stage of grow th) as the whole plot and substance type as the subplot to allow for a comparison of plants grow n under the two different water level treatments. Monsanto described the whole plot factor as arra nged as a randomized complete block design and the split-plot factor consisting of corn event MON 87460, the comparator control li ne, and the conventional commercial hybrid lines. Monsanto co llected forage (early dent stage) and grain samples (at physiological maturity) from corn event MON 87460 and the comparat or control line from all three blocks for each treatment and forage and grain samples from the f our 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 comp arison 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 conventiona l hybrid lines must have exhibited a phenotypic response indicative of the treatment. For the wate r-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 u sed 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 establis hed from the commercial references.

Results of analyses: Monsanto made the following observations and conclu sions 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 ha d 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 observa tions below the assay limit of quantization.

Compositional analysis of corn forage Monsanto reported no statistically significant differe nces 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 c ontrol 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 comp arator control line fell within the 99 percent

tolerance interval for conventional va rieties grown under similar conditions.

Compositional analysis of corn grain U.S. Study: Monsanto reported no statistically significant diffe rences 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, ph ytic acid, raffinose, ferulic acid, and p-coumaric acid between MON 87460 and the comparator control lin e. 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 inte rval for conventional varieties grown under similar conditions. Eicosenoic fatty acid content was statis tically 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 differe nces in moisture, crude protein, ash, carbohydrates by calculation, ADF, NDF, TDF, minerals (except fo r magnesium), all 18 amino acids, the 8 detectable fatty acids, 6 vitamins, phytic acid, raffinose, feru lic acid, and p-coumaric acid between MON 87460 and comparator control line. Ash and magnesium conten ts were statistically higher in MON 87460 than the comparator control line, but the values for MON 874 60 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 differe nces in moisture, crude fat, crude protein, ash, carbohydrates by calculation, ADF, NDF, TDF, 8 minera ls, 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 eico senoic 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 varieti es grown under similar conditions.

Summary of Compositional Analyses As noted above, in Monsanto’s co mbined site analyses, a few statis tically 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 add ition, 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 cons ensus document (OECD, 2002), or both. Monsanto

concluded that the differences were w ithin the natural variability of corn.

Conclusion

FDA evaluated Monsanto’s submission to determin e whether the developer’s product raises any safety issues with respect to the intended modification or w ith respect to the food itself, as discussed in the agency’s 1992 Policy Statement on New Plant Vari eties. Based on the information provided by the company and other information available to the ag ency, FDA did not identify any issues under Sections 402 and 409 of the Federal Food, Drug and Cosmetic Ac t 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 di fferent in composition or an y other relevant parameter from other corn varieties now grown, marketed, a nd consumed in the U.S. At this time, based on Monsanto’s data and information, the agency cons iders 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 comme rcial conventional corn varieties97 

### 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 fact ors 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, floweri ng phenology must overlap between source and sink populations, pollen transfer must occur, embr yo/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 cr op that produces abundant, la rge, and heavy pollen. The reproductive morphology of corn en courages cross-pollination between corn plants and there is no evidence (genetic or biologica l barriers) to indicate that ge ne 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 th e purity of hybrid seed production in corn are typica lly successful for maintaining 99 percent genetic purity (Ireland et al. 2006). The following are properties affecting po llen-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-po llination between nei ghboring corn fields can be effectively reduced, if not prevented, by desynchronizing flow ering between fields by altering planting dates. Hals ey 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 attr actants, bees typical ly do not visit the silks. When bee populations are established before corn flower ing, bees often avoid pollen collection from corn even when corn plants are close, becau se of bee preference for the flowers of other plant species. Therefore, insects, and honeybe es in particular, do not usually contribute to fertilization and cross-pol lination (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 floweri ng window of a given corn field. However, to maximize yield, most co rn 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 (B annert 2006). Tassel maturity and pollen release can occur on corn plan ts exposed to drought conditi ons, but silk deployment is delayed, reducing the fertilization and pollinat ion window of drought-affected corn plants (Hall and Twidwell 2002). Rain is disadvant ageous for pollen dispersal and frequent rainy weather can reduce fertilization in corn crops.99  

### Pollen migration distance: As stated above, corn polle n is very large and heavy (in relation to other grass species) and is prim arily dispersed downwi nd from tassels into adjacent rows of planted corn. Thus, isolati on 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. Generall y, 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-fertilizat ion (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 sugge st that gene flow distance follows an exponential decrease and diminishes greatly wi th 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 hi gh winds, cool temp eratures, and high humidity, contribute to in creased 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 so me studies have demonstrated higher rates of gene flow from ad jacent fields into field borders (Ireland et al. 2006). Luna et al. (2001) examined the e ffects of varied isola tion distances between maize plants in Mexico, and found that lo w levels of cross-pollination occurred at 328 feet (100 meters) and that no pollination oc curred 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) aw ay 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) dem onstrated 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 ge ne 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 cultiv ation suggests that cross-fer tilization rates are higher in open pollination production (Sanvido et al. 200 8). 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 betw een GE and non-GE corn. At distances of more than 328 feet ( 100 meters), the out-c rossing frequency betw een 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 polle n competition. These results indicate that when local pollen levels are low, incomi ng pollen has a competitive advantage, which results in a notably greater frequency of out-crossing than when the local pollen is100 

### abundant. Accordingly, large co rn donor fields can c ontribute to greate r pollen flow into small recipient fields as a result of po llen 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 (Zapio la 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 fe ral 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 cultiv ation for survival. Several key weedy traits

that would contribute to crop escape, traits associated with fe rality and volunteerism, have been selectively reduced in corn, resulting in a crop species not equipped for survival without management (Gould 1968). Also, several traits great ly reduce the ability of corn to disperse via seeds. Humans have selected corn to produce se eds that do not shatter and cannot disperse from the cob, and corn seeds are tight ly bound within a prot ective sheath of leaves, or husk (Zapiola and Mallory-Smith 2008). Corn seeds also lack dormancy, preventing eas y 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, b ecause 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-med iated gene flow in corn could occur as a result of seed mixing follo wing improper cleaning of field machinery, and improper seed purity and certification me thods. 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 a ll current corn production, corn is planted as hybrid seed to reduce intra-field variation in plant height, flower s ynchrony, 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 fo r replanting in subseque nt years; instead, it purchased each year (Fernandez-Cornejo 2004). Feral corn plants can sometimes occur along roadsides as a result of seed spill duri ng transport, but do not typically persist because of the same factors that reduce persis tence in fields. Therefore, the purity of seed stocks purchased in each year would de termine seed-mediated gene flow into corn

fields.

 

### Animal mediated seed dispersal: Several different animal sp ecies (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 Germa ny 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) de monstrated that passage of viable corn seed does not occur through malla rd 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 gr eatly reduced ability to persist and survive101 

### 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 fe deral lists ((USDA-AP HIS 2010, Crockett 1977, Holm et al. 1979, Muenscher 1980) though the Southern W eed Science Society lists it as a weed (USDA-NRCS 2010). Volunteer corn can sometimes overwinter and occur in fields following cultivation a nd crop rotation, particularly with soybeans, but does not persist and can be controlled using mechan ical or chemical measures. In addition, persistent populations of fera l corn are not common along tran sportation routes or other weedy environments (see Zapiola and Mall ory-Smith 2008). Based on the traits of modern corn and the factors necessary for co rn 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 ENVIRO NMENTAL 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 N umber of emerged plants per plot

Final stand count Pre-harvest N umber 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 N umber of plants per plot broken below the

ear

Root lodged plants Pre-harvest N umber 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 (l b/bu) Harvest Test weight of harvested shelled grain

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

15.5% moisture103 Characteristic Characteristic

Measured Evaluation Timing Evaluation Description (measurement endpoints

Dropped ears Pre-harvest N umber of mature ears dropped from plants

Plant

environmental

interactions Insect, disease and abiotic

stressors Variable, fro m 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, vi gor, chlorophyll content,

and biomass.

Volunteer potential After fall planting and
following spring N umber of plants present as volunteer corn in
plots

Survival outside of

cultivation Variable, fro m planting

to harvest Variable, phenotypic a ssessments from planting
to harvest that includes early and final stand
counts, vigor ratings, plan t height, and number of
ears and seed per plot

Source: (Reeves, 2010)