i

Syngenta Company Petition for Determination of 

Nonregulated Status of SYN-05307-1 Rootworm 

Resistant Corn

OECD Unique Identifier: 

SYN-Ø53Ø7-1

Draft Environmental Assessment 

May 2012

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

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

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

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

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

at (202) 720–2600 (voice and TDD). 

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

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

opportunity provider and employer. 

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

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

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

information. 

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

and/or Federal agencies before they can be recommended. 
TABLE OF CONTENTS PAGE

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ACRONYMS AND ABBREVIATIONS...........................................................................II

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

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

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

1.3 Petition for Determination of Nonregulated Status: Syngenta Event 5307 Corn 2

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

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

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

1.6.1 Environmental Protection Agency................................................................ 4

1.6.2 Food and Drug Administration ..................................................................... 5

1.7 Public Involvement .............................................................................................. 5

1.8 Issues Considered................................................................................................. 5

2 AFFECTED ENVIRONMENT.................................................................................. 7

2.1 Corn Biology........................................................................................................ 7

2.1.1 Persistence in the Environment/Weediness Potential................................... 9

2.2 Corn Production ................................................................................................... 9

2.2.1 Production and Yield .................................................................................... 9

2.2.2 Agronomic Practices................................................................................... 12

2.2.3 Specialty Corn Systems .............................................................................. 25

2.2.4 Raw and Processed Corn Commodities...................................................... 28

2.3 Physical Environment ........................................................................................ 28

2.3.1 Water Quality and Use................................................................................ 28

2.3.2 Soil.............................................................................................................. 30

2.3.3 Air Quality .................................................................................................. 30

2.3.4 Climate........................................................................................................ 30

2.4 Biological Environment ..................................................................................... 31

2.4.1 Animals....................................................................................................... 31

2.4.2 Plants........................................................................................................... 32

2.4.3 Soil Microorganisms................................................................................... 32

2.4.4 Biodiversity................................................................................................. 33

2.4.5 Gene Movement in the Natural Environment............................................. 33

2.5 Public Health...................................................................................................... 33

2.5.1 Human Health ............................................................................................. 34

2.5.2 Animal (Livestock) Health ......................................................................... 35

2.5.3 Worker Safety ............................................................................................. 36

2.6 Socioeconomic ................................................................................................... 36

2.6.1 Domestic Economic Environment .............................................................. 36

2.6.2 Trade Economic Environment .................................................................... 38

2.6.3 Social Environment..................................................................................... 38
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3 ALTERNATIVES..................................................................................................... 40

3.1 No Action Alternative: Continuation as a Regulated Article............................ 40

3.2 Proposed Action: Determination That Event 5307 Corn Is No Longer a Regulated 

Article ................................................................................................................ 40

3.3 Alternatives Considered But Rejected from Further Consideration .................. 40

3.3.1 Prohibit Any Event 5307 Corn from Being Released................................. 41

3.3.2 Approve the Petition in Part........................................................................ 41

3.3.3 Isolation Distance between Event 5307 Corn and Non-GE Corn Production 

and Geographical Restrictions.................................................................... 41

3.3.4 Requirement of Testing for Event 5307 Corn............................................. 42

3.4 Comparison of Alternatives ............................................................................... 42

4 ENVIRONMENTAL CONSEQUENCES ............................................................... 44

4.1 Scope of Environmental Analysis...................................................................... 44

4.1.1 Persistence in the Environment/Weediness Potential................................. 45

4.2 Corn Production ................................................................................................. 45

4.2.1 Production and Yield .................................................................................. 45

4.2.2 Agronomic Practices................................................................................... 46

4.2.3 Specialty Corn Systems .............................................................................. 52

4.2.4 Raw and Processed Corn Commodities...................................................... 57

4.3 Physical Environment ........................................................................................ 57

4.3.1 Water Quality and Use............................................................................... 57

4.3.2 Soil.............................................................................................................. 59

4.3.3 Air Quality .................................................................................................. 60

4.3.4 Climate........................................................................................................ 60

4.4 Biological Environment ..................................................................................... 61

4.4.1 Animals....................................................................................................... 62

4.4.2 Plants........................................................................................................... 68

4.4.3 Soil Microorganisms................................................................................... 68

4.4.4 Biodiversity................................................................................................. 70

4.4.5 Gene Movement in the Natural Environment............................................. 71

4.5 Public Health...................................................................................................... 72

4.5.1 Human Health ............................................................................................. 72

4.5.2 Animal (Livestock) Health ......................................................................... 74

4.5.3 Worker Safety ............................................................................................. 75

4.6 Socioeconomics.................................................................................................. 77

4.6.1 Domestic Economic Environment .............................................................. 77

4.6.2 Trade Economic Environment .................................................................... 79

4.6.3 Social Environment..................................................................................... 79

5 CUMULATIVE EFFECTS ...................................................................................... 81

5.1 Methodology and Assumptions.......................................................................... 81
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5.2 Reasonably Foreseeable Future Actions............................................................ 81

5.3 Cumulative Effects Analysis.............................................................................. 82

5.3.1 Corn Production.......................................................................................... 82

5.3.2 Physical Environment ................................................................................. 85

5.3.3 Biological Environment.............................................................................. 86

5.3.4 Public Health............................................................................................... 88

5.3.5 Socioeconomics .......................................................................................... 89

6 THREATENED AND ENDANGERED SPECIES ................................................. 90

6.1 The Endangered Species Act and APHIS Section 7 Process............................. 90

6.2 Potential Effects of 5307 Corn on TES.............................................................. 91

7 CONSIDERATION OF EXECUTIVE ORDERS AND OTHER FEDERAL LAWS 

RELATING TO ENVIRONMENTAL IMPACTS ................................................. 96

7.1 Executive Orders with Domestic Implications................................................... 96

7.1.1 Executive Order 12898: Environmental Justice ......................................... 96

7.1.2 Executive Order 13045: Protection of Children ........................................ 96

7.1.3 Executive Order 13112: Invasive Species .................................................. 97

7.1.4 Executive Order 13186: Migratory Birds................................................... 97

7.2 Executive Orders with International Implications ............................................. 98

7.3 Other Federal Laws............................................................................................ 99

7.3.1 Clean Water Act.......................................................................................... 99

7.3.2 Clean Air Act ............................................................................................ 100

7.3.3 National Historic Preservation Act ........................................................... 100

7.3.4 Federal Laws Regarding Unique Characteristics of Geographic Areas ... 101

7.4 Regulations, Policies, and Executive Orders ................................................... 101

8 REFERENCES ....................................................................................................... 103

9 LIST OF PREPARERS........................................................................................... 122

APPENDIX A SUPPLEMENTAL INFORMATION ON INSECTICIDE USE WITH 

TRAITS IN CORN ................................................................................................ 123

APPENDIX B DECISION TREE ON WHETHER SECTION 7 CONSULTATION WITH 

FWS IS TRIGGERED FOR PETITIONS ............................................................. 130
TABLE OF CONTENTS PAGE

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LIST OF TABLES

Table 1: Transgenic Corn Cultivars Containing Bt-derived Proteins that are no longer subject to 

the regulatory requirements of 7 CFR Part 340.............................................................................. 8

Table 2: Corn Insect Pests............................................................................................................. 16

Table 3: National List of Approved Insecticides for Organic Production Systems...................... 26

Table 4: List of Corn Mycotoxins Toxic to Animals Consuming Contaminated Feed................ 36

Table 5: Corn and Crop Cash Receipts........................................................................................ 37

Table 6: Summary of Environmental Consequences.................................................................... 42

Table 7: Non-organic and organic corn production (harvested acres) in 2007............................ 55

Table 8: Nontarget organism TER values for eCry3.1Ab. ........................................................... 65

Table 9: Commercially Available Corn Breeding Stack Combinations with Insect Control Traits

....................................................................................................................................................... 76

Table 10: Planned Stacking Combinations*................................................................................ 82

Table 11: Threatened or Endangered Coleopteran Species Occurring in Corn Growing Regions

....................................................................................................................................................... 94

LIST OF FIGURES

Figure 1: Corn Planted in U.S. by County in 2010...................................................................... 10

Figure 2: US Corn Acres 1992-2012. .......................................................................................... 11

Figure 3: Corn Rootworm Distribution Map ................................................................................ 18

Figure 4: Water Use by Corn Plant in the First 100 Days after Planting..................................... 29
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ACRONYMS AND ABBREVIATIONS

μg/g Micrograms per gram

ACHP Advisory Council on Historic Properties

AIA Advanced Informed Agreement

AMS Agricultural Marketing Service (also USDA-AMS)

AOSCA Association of Official Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service (also USDA-APHIS)

ARMS Agricultural Resource Management Survey

ARS Agricultural Research Services (also USDA-ARS)

ATTRA Appropriate Technology Transfer for Rural Areas

BRS Biotechnology Regulatory Service

Bt Bacillus thuringiensis

C Centigrade

C3 Three-carbon molecule photosynthetic pathway

C4 Four-carbon molecule photosynthetic pathway

CBD Convention on Biological Diversity

CEQ Council on Environmental Quality

CFR Code of Federal Regulations

CO2 Carbon dioxide

CRP

CRW

Conservation Reserve Program

Corn Rootworm

Cry Crystal proteins

EA Environmental Assessment

EIS Environmental Impact Statement

EO Executive Order

EPA Environmental Protection Agency (also US-EPA)

ER Environmental Report

ERS Economic Research Service (also USDA-ERS)

ESA Endangered Species Act

FATUS Foreign Agricultural Trade of the United States

FAS Foreign Agricultural Service (also USDA-FAS)

FB1 Fumonisin B1

FDA Food and Drug Administration (also USDHHS-FDA)

FFP Food, feed, or processing

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FESTF FIFRA - Endangered Species Task Force

FONSI Finding of No Significant Impact

FR Federal Register

FWS Fish and Wildlife Service (also USFWS)

GHG Greenhouse gases
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ACRONYMS AND ABBREVIATIONS

IMS Information Management System

IP Identity Preservation

IPM Integrated Pest Management

IPCC Intergovernmental Panel on Climate Change

IPPC International Plant Protection Convention

IRM Insect Resistance Management

LMO Living modified organisms

LOQ Limit of quantification

MJD Multi-Jurisdictional Database

N2O Nitrous oxide

NAPPO North American Plant Protection Organization

NASS National Agricultural Statistics Service (also USDA-NASS)

NCGA National Corn Growers Association

NEPA National Environmental Policy Act

NHPA National Historic Preservation Act

NOP National Organic Program

NPS Nonpoint source

NPTN National Pesticide Telecommunications Network

NRC National Research Council

NRCA Natural Resources Conservation Service (also USDA-NRCS)

OECD Organization for Economic Cooperation and Development

OTA Organic Trade Association

PIPs Plant-incorporated protectants

pmi Phosphomannose isomerase gene (also known as manA)

PMI Phosphomannose isomerase protein

PPA Plant Protection Act

PPRA Plant Pest Risk Assessment

PRA Pest Risk Analysis

RR2 Roundup-Ready© Corn 2

RSPM Regional Standards for Phytosanitary Measures

SCGO Seed Corn Growers of Ontario

TSCA Toxic Substances Control Act

US United States

USACOE United States Army Corps of Engineers

USDA United States Department of Agriculture

USDHHS United States Department of Health and Human Services

US-EPA United States Environmental Protection Agency (also EPA, USEPA)

USFWS United States Fish and Wildlife Service (also FWS)

USGC U.S. Grains Council

Vip Vegetative insecticidal protein
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1 PURPOSE AND NEED

1.1 Regulatory Authority

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

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

ensuring the health and care of plants and animals. The agency improves agricultural productivity 

and competitiveness, and contributes to the national economy and public health. USDA asserts that 

all methods of agricultural production (conventional, organic, or the use of genetically engineered 

varieties) can provide benefits to the environment, consumers, and farm income.

Since 1986, the United States (U.S.) government has regulated genetically engineered (GE) 

organisms pursuant to a regulatory framework known as the Coordinated Framework for the 

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

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

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

products and explains how federal agencies will use existing federal statutes in a manner that ensures 

public health and environmental safety while maintaining regulatory flexibility to avoid impeding the 

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

guiding principles:

(1) Agencies should define those transgenic organisms subject to review to the extent 

permitted by their respective statutory authorities;

(2) Agencies are required to focus on the characteristics and risks of the biotechnology 

product, not the process by which it is created; and

(3) Agencies are mandated to exercise oversight of genetically engineered organisms only 

when there is evidence of “unreasonable” risk.

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

agencies involved in regulating genetically engineered organisms: APHIS, the US Food and Drug 

Administration (FDA), and the US Environmental Protection Agency (US-EPA).

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

Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that genetically 

engineered organisms do not pose a plant pest risk to the environment.

The FDA regulates genetically engineered organisms under the authority of the Federal Food, 

Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and proper labeling of all 

plant-derived foods and feeds, including those that are genetically engineered. To help developers 

of food and feed derived from genetically engineered crops comply with their obligations under 

federal food safety laws, FDA encourages them to participate in a voluntary consultation process. 

All food and feed derived from genetically engineered crops currently on the market in the United 

States have successfully completed this consultation process. The FDA policy statement 

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

engineered, was published in the Federal Register (FR) on May 29, 1992 (57 FR 22984-23005). 

Under this policy, FDA uses what is termed a consultation process to ensure that human food and 

animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial 

distribution of bioengineered food.
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The US-EPA regulates plant-incorporated protectants (PIPs) under the Federal Insecticide, 

Fungicide, and Rodenticide Act. US-EPA also sets tolerance limits for residues of pesticides on 

and in food and animal feed, or establishes an exemption from the requirement for a tolerance, 

under the Federal Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control 

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

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

organism through biotechnology.

1.2 Regulated Organisms

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

and environment using a dynamic and science-based regulatory framework that allows for the safe 

development and use of genetically engineered organisms. APHIS regulations at 7 Code of Federal 

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

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

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

products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act 

or to the regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to 

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

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

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

regulated under part 340 when APHIS has reason to believe that the GE organism may be a plant pest 

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

risk.

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

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

or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner is required to provide 

information related to plant pest risk that the agency may use to determine whether the regulated 

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

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

the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. 

1.3 Petition for Determination of Nonregulated Status: Syngenta Event 5307 Corn

Syngenta Biotechnology, Inc. submitted an initial petition (10-336-01p) to APHIS in 2010, which 

was revised in 2011 (Syngenta, 2011c), seeking a determination of nonregulated status of 

Event 5307 rootworm-resistant corn (hereafter referred to as Event 5307 or 5307 corn). Nonregulated 

status would include 5307 corn, progeny from crosses between 5307 corn and conventional corn, and 

progeny from crosses of 5307 corn with other transgenic corn that has been determined to have 

nonregulated status. Event 5307 corn is currently regulated under the PPA. 

Interstate movements and field trials of Syngenta 5307 corn have been conducted under permits 

issued or notifications acknowledged by APHIS from 2005 through 2010. Data resulting from these 

field trials are described in the petition; (Syngenta, 2011c). Notifications acknowledged and permits 

issued by APHIS are listed in the petition (Syngenta, 2011c). The test sites represent diverse regions 

of the U.S., including the major growing areas of the Midwest (Wisconsin, Michigan, Minnesota 
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Missouri, Iowa, Illinois, Indiana, Kansas, Kentucky, Nebraska, South Dakota, Ohio, Colorado and 

Arkansas), and winter nurseries in Puerto Rico and Hawaii. Field tests conducted under APHIS 

oversight allow for evaluation in agricultural settings under confinement measures designed to 

minimize the likelihood of persistence in the environment after completion of the field trial. Under 

confined field trial conditions, data are gathered on multiple parameters and used by applicants to 

evaluate agronomic characteristics and product performance. These data are also valuable to APHIS 

for assessing the potential for a new variety to pose a plant pest risk. The data evaluated for Syngenta 

5307 corn may be found in the APHIS Plant Pest Risk Assessment (PPRA (USDA-APHIS, 2011)).

1.4 Purpose of Product

Corn rootworm (Diabrotica) larvae feed on the roots of growing corn plants and are widespread and 

major pests of US corn (Hoeft et al., 2000). Corn (Zea mays L., maize) derived from Syngenta’s 

transformation Event 5307 contains a unique engineered insecticidal protein, eCry3.1Ab, that is 

active against three economically important corn rootworm species that cause significant damage to 

the US corn crop annually. This engineered pesticide provides corn plants with resistance to larval 

feeding damage by western corn rootworm (Diabrotica virgifera virgifera), northern corn rootworm 

(D. longicornis barberi) and Mexican corn rootworm (D. virgifera zeae). Event 5307 corn 

demonstrates efficacy in controlling these damaging pests (see section VIII.b., (Syngenta, 2011c).

Corn varieties containing the transgene ecry3.1Ab have the potential to displace applications of 

conventional US-EPA-restricted use rootworm insecticides. The new protein, eCry3.1Ab, may act on 

target pests via a different protein target, which could reduce the selection pressure on pest populations 

to evolve resistance to other plant-expressed Cry proteins that also control corn rootworm (section IX in 

Syngenta 2011c). Growers are expected to derive benefits from 5307 corn as an alternative to the 

application of conventional insecticides, as well as realize economic benefits through increased crop 

yield under conditions of pest pressure, and reduced costs of insecticide applications. The availability of 

5307 corn is expected to contribute to the significant trend in reduced use of US-EPA-restricted use 

insecticides and extends the useful life of other commercially available corn rootworm-protected Btexpressing cultivars (Cry3Bb1, Cry34Ab1/Cry35Ab1, and mCry3A corn; section X, (Syngenta, 

2011c); (USDA-ERS, 2011c).

As identified by the applicant, the benefits of 5307 corn include reduced use of US-EPA-restricted 

use insecticides (typical extension recommendation shows that 11 of 13 dry or liquid insecticides 

for corn rootworm are restricted use (Bessin, 2004), improved worker safety due to the reduced 

exposure of chemical insecticides (Syngenta, 2011c), reductions in the use of fossil fuels to apply 

chemical insecticides, economic benefits for growers, improved insect resistance management, and 

increased competition in the marketplace for insect-protected seed products (Syngenta, 2011c).

1.5 APHIS Response to Petition for Nonregulated Status

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

APHIS has issued regulations for the safe development and use of GE organisms. As required by 7 

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

genetically engineered organisms, including GE plants such as Syngenta 5307 corn. When a petition 

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

organism is unlikely to pose a plant pest risk. If APHIS determines based on its PPRA that the 

genetically engineered organism is unlikely to pose a plant pest risk, the genetically engineered 
4

organism is no longer subject 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 Council of Environmental 

Quality’s National Environmental Policy Act (NEPA) regulations and the USDA and APHIS 

NEPA implementing regulations and procedures (40 CFR parts 1500-1508, 7 CFR part 1b, and 7 

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

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

Syngenta 5307 corn.

1.6 Coordinated Framework Review

1.6.1 Environmental Protection Agency

The US-EPA regulates plant-incorporated protectants (PIPs) under FIFRA (7 U.S.C. 136 et seq.) and 

certain biological control organisms under TSCA (15 U.S.C. 53 et seq.). Syngenta has obtained an 

Experimental Use Permit (67979-EUP-8) from US-EPA that allows for broad-scale field testing of 

5307 corn and various breeding stack combinations that include 5307 corn. The Experimental Use 

Permit was initially granted on June 1, 2010 with effect through February 28, 2012 (US-EPA, 2010c)

and was extended (US-EPA, 2012) on March 3, 2011 with effect through December 31, 2013. In 

connection with this Experimental Use Permit, US-EPA established and then extended (US-EPA, 

2011a) a previous temporary exemption from the requirement of a tolerance for eCry3.1Ab residues 

in corn commodities, pursuant to §408(d) of the Federal Food, Drug, and Cosmetic Act. 

Phosphomannose isomerase (PMI), the selectable marker protein produced by 5307 corn plants, is 

exempt from food and feed tolerances (US-EPA, 2004).

In April 2011, Syngenta submitted applications to the US-EPA for registration of the eCry3.1Ab PIP

in 5307 corn (Appendix B, p. 15, (Syngenta, 2011c)) and in two breeding stacks involving specific 

GE corn traits that are no longer subject to the requirements of Part 340 and the plant pest provisions 

of the PPA (US-EPA, 2011f). These breeding stacks include specifically Bt11 × MIR604 × TC1507 

× 5307 × GA21 and Bt11 × MIR162 × MIR604 × TC1507 × 5307 × GA21 corn. In addition to the 

corn rootworm control provided by 5307 corn, the controls provided by other nonregulated 

constituents of these stacked combinations are:

• A Cry1Ab protein for lepidopteran control (Bt11);

• A modified Cry3A protein for corn rootworm control (MIR604);

• A Cry1F protein for lepidopteran control (TC1507);

• A double mutated 5-enolpyruvylshikimate-3-phosphate synthase enzyme for glyphosate 

tolerance (GA21);

• A Vip3Aa20 protein for lepidopteran control (MIR162); and

• A phosphinothricin acetyl transferase enzyme for glufosinate tolerance (Bt11 and TC1507).

The US-EPA registration was sought for the PIP in 5307 corn as a stand-alone cultivar (i.e., not 

part of a breeding stack) will be for a manufacturing-use product; Syngenta will not seek an enduse product registration from US-EPA for 5307 corn (see Section I.C.2., (Syngenta, 2011c).

Rather, commercial registrations were sought from US-EPA for the two breeding stack products 
5

that include 5307 corn. A conditional registration was made by EPA for the stacked product, EPA 

Reg. Number 67979-17 on June 10, 2011. Concurrently, Syngenta also submitted a petition 

(Petition No. 1F7857) to the US-EPA to establish a nonexpiring exemption from the requirement of 

a tolerance for eCry3.1Ab residues in food and feed commodities.

1.6.2 Food and Drug Administration

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

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

including those that are GE, in the Federal Register on May 29, 1992 (57 FR 22984). Under this 

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

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

distribution of bioengineered food. 

Event 5307 corn falls within the scope of the FDA policy statement concerning regulation of food 

products derived from new plant varieties, including those developed by genetic engineering (USFDA, 1992 (US-FDA, 1992). Syngenta initiated a voluntary pre-market consultation process with 

FDA and submitted a safety and nutritional assessment for 5307 corn in January 2011 

(Appendix B, Syngenta 2011c).

1.7 Public Involvement

APHIS routinely seeks public comment on draft EAs prepared in response to petitions for 

nonregulated status of GE organisms. APHIS does this through a notice published in the Federal 

Register. The issues discussed in this EA were developed by considering the public concerns as well 

as issues raised in public comments submitted for other EAs of GE organisms, concerns raised in 

lawsuits, as well as those issues of concern that have been raised by various stakeholders. These 

issues, including those regarding the agricultural production of corn using various production 

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

potential environmental impacts of Syngenta 5307 corn.

This EA, the petition submitted by Syngenta, and APHIS’s PPRA will be available for public 

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

day period will be analyzed and used to inform APHIS’ determination decision of the regulated status 

of Syngenta 5307 corn and to assist APHIS in determining whether an Environmental Impact 

Statement (EIS) is required prior to the determination decision of the regulated status of this soybean 

variety.

1.8 Issues Considered

The list of issues considered in this draft EA were developed by APHIS through experience in 

considering public concerns and issues raised in public comments submitted for other EAs of GE 

organisms. The resource areas considered also address concerns raised in previous and unrelated 

lawsuits, as well as issues that have been raised by various stakeholders in the past. The resource 

areas considered in this EA can be categorized as follows:

Corn Biology

o Persistence in the environment and weediness potential

Corn Production
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o Acreage and areas of production

o Agronomic practices

o Specialty systems

o Raw and processed agricultural commodities

Physical Environment

o Water quality and use

o Soil

o Air quality

o Climate

Biological Environment

o Animals

o Plants

o Soil microorganisms

o Biodiversity

o Gene movement in the natural environment

Public Health

o Human health

o Animal (livestock) health

o Worker safety

Socioeconomic Factors

o Domestic economic environment

o Trade economic environment

o Social environment
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2 AFFECTED ENVIRONMENT

The Affected Environment section provides an overview of the use and composition of corn, 

followed by a discussion of the current conditions of those aspects of the human environment 

potentially impacted by a determination of nonregulated status of 5307 corn. For the purposes of this 

draft EA, those aspects of the human environment are: corn production practices, the physical 

environment, biological resources, public health, and socioeconomic issues. 

Conventional farming as defined in this document includes any farming system where synthetic 

pesticides or fertilizers may be used. This definition of conventional farming also includes the use of 

GE varieties of corn that have been determined by APHIS to be no longer subject to the regulatory 

requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act.

2.1 Corn Biology

Maize, or corn, is a member of the Maydeae tribe of the grass family Poaceae (OECD, 2003 (OECD, 

2003). The western hemisphere genera Zea and Tripsacum are included in the tribe Maydeae. The 

Asian genera of Maydeae are Coix, Polytoca, Chionachne, Schlerachne and Trilobachne (OECD, 

2003 (OECD, 2003).

Corn is a robust monoecious (i.e., having separate male and female flowers for each plant) annual 

plant, which was developed through artificial selection and does not occur in natural ecosystems 

outside of cultivation (OECD, 2003). The corn plant is adapted for high productivity because it has a 

large leaf area and a modified photosynthetic pathway that allows it to survive extended periods of 

drought (Frost and Gillman, 2011). The corn plant, along with a limited number of other plants like 

sugarcane, millet, and sorghum, uses the C4 photosynthetic pathway. At a biochemical level, these 

plants convert carbon dioxide (CO2) into a four-carbon molecule in contrast to the more common 

photosynthetic pathway in which CO2 is converted into a three-carbon molecule (Frost and Gillman, 

2011). C4 photosynthesis allows the corn plant to produce more dry matter (i.e., in various 

combinations of carbohydrates, proteins, oils, and mineral nutrients) per unit of water transported 

than the C3 photosynthetic pathway. Because of their high photosynthetic efficiency, the C4 crops 

like corn are favored for ethanol production and, also sugarcane but much less favorably (USDA, 

2006)

Zea mays is an allogamous plant (i.e., cross-fertilizes by pollen from one flower to stigmas on 

another) that propagates through seed produced predominantly by cross pollination. (OECD, 2003)

Pollen is transferred by wind and, in controlled breeding situations, by humans. Corn mostly can only 

be crossed experimentally with species of the genus Tripsacum, and the progeny are neither 

environmentally fit nor reproductively robust (USDA-APHIS, 2011); however, wild species of its 

own genus Zea (teosinte: Z. diploperennis, Z. perennis, Z. luxurians, Z. nicaraguanensis) may 

hybridize with corn under natural conditions but these species are rare if occurring at all in the US 

and no domestic hybridization has been described (see Section 2.4.4, Gene Movement in the Natural 

Environment and (USDA-APHIS, 2011). Corn is not weedy, and does not persist outside of 

cultivation. There are no reports in which corn propagated vegetatively under field conditions, and 

the only known propagation method for corn is through seed germination (OECD, 2003). Corn is 

primarily grown in warm temperate climates. Corn seed is sensitive to cold and typically does not 

survive freezing winter conditions (OECD, 2003). Consequently, corn has no innate dormancy

(OECD, 2003).
8

Table 1: Transgenic Corn Cultivars Containing Bt-derived Proteins that are no longer 

subject to the regulatory requirements of 7 CFR Part 340

Cultivar Filed By/Petition Number Transgenic feature

Event 176 Ciba Seeds 

(petition 94-319-01p)

Lepidopteran (European corn 

borer) resistant, expressing 

Cry1Ab

MON 80100 Monsanto

(petition 95-093-01p)

Lepidopteran resistant, 

expressing Cry1Ab

Bt11 Northrup King Company

(petition 95-195-01p)

Lepidopteran resistant, 

expressing Cry1Ab, and 

glufosinate tolerant

DBT418 DeKalb

(petition 96-291-01p)

Lepidopteran resistant, 

expressing Cry1Ac, and 

glufosinate tolerant

MON 809 and 

MON 810

Monsanto

(petition 96-017-01p)

Lepidopteran resistant, 

expressing Cry1Ab

MON 802 Monsanto

(petition 95-317-01p)

Lepidopteran resistant, 

expressing Cry1Ab, and 

glyphosate tolerant

CBH-351 AgrEvo

(petition 97-265-01p)

Lepidopteran resistant, 

expressing Cry9C, and 

glufosinate tolerant

Line 1507 Mycogen 

(petition 00-136-01p)

Lepidopteran resistant, 

expressing Cry1F, and 

glufosinate tolerant

MON 863 Monsanto

(petition 01-137-01p )

Corn rootworm resistant, 

expressing Cry3Bb1

DAS 6275 Dow

(petition 03-181-01p)

Lepidopteran resistant, 

expressing Cry1F, and 

glufosinate tolerant

DAS 59122 Dow

(petition 03-353-01p)

Corn rootworm resistant, 

expressing Cry34/35Ab1, and 

glufosinate tolerant

MON 88017 Monsanto

(petition 04-125-01p)

Corn rootworm resistant, 

expressing Cry3Bb1, and 

glyphosate tolerant

MIR604 Syngenta

(petition 04-362-01p)

Corn rootworm resistant, 

expressing modified Cry3A

MON 89034 Monsanto

(petition 06-298-01p)

Lepidopteran resistant, 

expressing Cry1A.105 and 

Cry2Ab2

MIR162 Syngenta

(petition 07-253-01p)

Lepidopteran resistant, 

expressing Vip3Aa20 

From: (USDA-APHIS, 2011b). http://www.aphis.usda.gov/biotechnology/not_reg.html

Humans have been selectively breeding corn for greater than 4300 years to emphasize desired 

characteristics such as increased yield and other traits (see review in, (Vigouroux et al., 2011).

Beginning in 1996, transgenic corn products were introduced in the US market by seed companies, 

thereby adding new genetic traits to modern corn varieties. Corn cultivars representing 30 different 

transformation events are no longer subject to the regulatory requirements of 7 CFR Part 340

(USDA-APHIS, 2011b). These cultivars were genetically engineered to offer insect resistance, 

herbicide tolerance, and other traits. Sixteen of these cultivars, as listed in Table 1: Transgenic Corn 

Cultivars Containing Bt-derived Proteins that are no longer subject to the regulatory requirements of 
9

7 CFR Part 340, contain proteins derived from Bacillus thuringiensis (Bt) and are known as Bt corn 

cultivars. Bt corn cultivars assist growers in preventing insect damage that would otherwise cause 

yield loss. The Bt “crystal” proteins (referred to as Cry proteins) in these cultivars are insecticidal 

against certain Coleoptera or Lepidoptera and exert their insecticidal activity when they:

1. Are ingested by the insect and solubilized in the insect gut;

2. Are activated by specific proteolytic cleavage by midgut enzymes;

3. Bind to specific receptors on the surface of the insect midgut; and

4. Form ion channels in the gut membrane.

2.1.1 Persistence in the Environment/Weediness Potential

Corn, a highly domesticated plant (Troyer, 2004) is dependent upon humans for survival (Hallauer, 

2004). It does not persist in the environment outside of cultivated areas and does not have a potential 

to develop as a weed. Corn is not listed on the Federal noxious weed list (USDA-APHIS, 2010a). It 

is grown throughout the world without any report that it is a weed or that it forms persistent feral 

populations, although corn seed from a previous year’s crop can overwinter in fields and germinate 

the following year in warmer areas. Manual or chemical measures are often applied to remove these 

volunteers, but the plants that are not removed do not result in feral populations in following years.

Transgenic insect-resistant corn plants are no better at establishing feral populations than nontransgenic corn (Raybould et al., 2011). A field study of transgenic insect-resistant hybrids, nontransgenic hybrids, and native Mexican landraces planted and allowed to naturally propagate for two 

years resulted in no viable plants, indicating that the populations had died out (Raybould et al., 2011). 

There were no differences in the replacement capacity of transgenic corn hybrids and the 

nontransgenic control hybrids.

2.2 Corn Production

This section describes corn production and yield in the US, current agronomic practices, specialty 

corn production systems, raw and processed corn commodities. Corn is grown for animal feed, 

human food, vegetable oil, high fructose corn syrup, starch, fermentation into ethanol, and many 

other uses.

2.2.1 Production and Yield

Corn is cultivated in temperate regions that provide sufficient moisture and an adequate number of 

frost-free days to reach maturity. US corn production is primarily focused in the Corn Belt, an area 

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

Ohio, Wisconsin, and Missouri. The Corn Belt has a combination of seasonal warm weather, rainfall, 

and favorable soil conditions for corn growth. Approximately 67.4 million acres of corn, representing 

approximately 73 percent of the US total of 91.9 million acres, was planted in these ten states in 2011

(USDA-NASS, 2012a); (USDA-NASS, 2012b). The planted acres of corn for each county in selected 

states in 2010 are shown in Fig. 1.
10

 Source: USDA-NASS, 2011c (USDA-NASS, 2011c).

Nationally, planted corn acreage has increased from approximately 75 million acres in 1990 to a peak 

of nearly 95 million acres in 2008, as shown in Figure 2: US Corn Acres 1992-2012. Corn growers 

were projected to plant more than 92 million acres of corn in 2011. Harvested acreage lags planted 

acreage by 5 to 7 million acres each year due to losses from adverse weather and insect damage. 

Figure 1: Corn Planted in U.S. by County in 2010
11

Figure 2: US Corn Acres 1992-2012.

Source: USDA-ERS, 2012, at http://www.nass.usda.gov/Charts_and_Maps/Field_Crops/cornac.asp.

The majority of domestic corn is produced for livestock feed (grain and silage) and fuel (ethanol), 

comprising 38 and 37 percent, respectively of the market (USDA-NASS, 2011f). Corn for grain 

production in 2010 was estimated at 12.4 billion bushels, 5 percent below the record high production 

of 13.1 billion bushels set in 2009 (USDA-NASS, 2011d). Grain yield was approximately 

152.8 bushels per acre, 11.9 bushels below the record high yield of 164.7 bushels per acre set in 

2009. Since 1990, corn yields have increased by about 2.0 bushels per acre per year (Savage, 2011).

The USDA-Economic Research Service (ERS) provides 10-year projections of supply and utilization 

for major field crops, including corn, grown in the US. ERS projects that an average of 90.2 million 

acres of corn will be planted from 2011 through 2020 (USDA-ERS, 2011f). Output in bushels will 

increase about 10% during this period, according to ERS.

Expanding output is attributable to yield growth. The projected 2010/11 corn yield is based on the 

simple linear trend since 1990. The longer term trend for 2011/12 and later years reflects an annual 

yield increase of 2.0 bushels per acre per year, resulting in record corn production in 2011/12 and 

beyond (USDA-ERS, 2011f). Increases in corn yields have been driven by improvements in plant 

genetics, machinery, and cultivation practices that have allowed for faster, more precise planting and 

earlier harvesting (USDA-ERS, 2011b). The latest round of advances in genetics and planting 

technology is expected to be fully adopted by the early years of the projections. Thus, longer term 

yield gains are expected to be somewhat slower than during the late 1990s and early 2000s (USDAERS, 2011b). Gains may continue to be supported by improved genetics, including advances in plant 
12

utilization of water and fertilizer, and seed developers currently include these research directions 

(Anonymous, 2011).

In 2011, approximately 88 percent of the US corn fields were planted with transgenic crops for pest 

management (USDA-NASS, 2011a). As described in Section 2.2.2.3, Insect Management, and 

Section 2.2.2, Weed Management, the transgenic crops provide insect resistance and herbicide 

tolerance, as well as production-related traits. Insect-resistant varieties containing Bt-derived 

transgenes comprise about 16 percent of the US corn acreage, and herbicide-tolerant varieties some 

23 percent; products combining both traits were planted on 49 percent of the corn acreage (USDANASS, 2011a).

2.2.2 Agronomic Practices

Corn growers choose agronomic practices that maximize grain yield. Grain yield can be affected by 

cropping practices such as crop rotation and tillage techniques, supplemental irrigation based on soil 

and climate conditions, and methods to manage insects, disease, and weeds. This section describes 

common agronomic practices for corn.

Crop Rotation and Tillage

Crops grown in rotation typically have higher yields, lower weed biomass, and lower insect 

populations than those grown continuously (Hicks and Thomison, 2004). Corn is typically rotated 

with legumes such as soybeans or alfalfa. Corn/soybean rotations have been found to have 9 percent 

higher yields than corn/corn rotations (Hicks and Hoverstad, 2007). Weed population density and 

biomass may be reduced using crop rotation (temporal diversification) and intercropping (spatial 

diversification) strategies (Liebman and Dyck, 1993). The risk of yield losses due to damage from 

some insects, particularly corn rootworm, decreases when corn is rotated with other crops (Bessin, 

2004).

Legumes provide the greatest rotation benefits for corn; the benefit is principally attributed to the 

nitrogen-fixing property of legumes but other factors (such as increased organic matter and reduced 

weed seed banks) (Eisenthal, 2011). may also contribute to higher yield. Corn is rotated with 

soybeans annually in much of the Corn Belt, but oats and alfalfa may also be rotated with corn and 

soybeans or during fallow years in semi-annual to five-year cycles (Hicks and Thomison, 2004). In 

2010, 71 percent of the acres planted in corn were in a rotation program in the last three years

(USDA-NASS, 2011). While tillage in parts of the corn belt remains an effective strategy for 

controlling buildup of corn rootworm, the appearance of two variant behaviors of rootworm have 

made this strategy less useful. Because rotation was practiced extensively, Western corn rootworm in 

some areas began laying eggs in soybean fields for overwintering, and then hatch to attack corn in 

the spring or early summer of the next season (Gray et al., 2009). A variant of the Northern corn 

rootworm can extend egg diapause from one to two or three winters, again timing egg emergence 

until a rotated corn crop might be planted (Levine and Oloumi-Sadeghi, 1991). If the variants are not 

an issue, then rootworm damage is usually not a problem until the third or subsequent season of 

continuous corn production (Penn-State-Extension, 2012) unless grass and volunteer corn were 

common in the planted field the previous year.

Tilling the soil reduces weeds that would otherwise crowd or compete with the corn crop (US-EPA, 

2009). Until recently, conventional tillage was commonplace, using moldboard plows prior to 

planting or after harvest. Reduced or conservation tillage methods have largely replaced conventional 
13

methods (for corn, 40% conservation tillage, 24% reduced tillage) (CTIC, 2008). Reduced tillage 

uses chisel plows and results in less soil disturbance. Conservation tillage also uses chisel plows and 

includes no-till and focused methods such as strip, ridge, or mulch tillage. The intensive plowing of 

conventional tillage results in less than 15 percent crop residue (unharvested plant material); reduced 

tillage is associated with 15 to 30 percent crop residue; and conservation tillage is associated with at 

least 30 percent crop residue and substantially less soil erosion than other tillage practices (US-EPA, 

2009). Because of its low cost and positive impact on soil quality, conservation tillage is currently 

and widely practiced in the Midwestern US. In 2010, 62 percent of the acres planted in corn used a 

no-till or minimum tillage method in a USDA survey of program states (USDA-NASS, 2011b)

similar to the percentage identified by the CTIC survey (CTIC, 2008).

Irrigation

Soil and water (rainfall or irrigation) are the key resources in all crop production. Soil supports the 

basic physical, chemical, and biological processes for corn to grow, and specific soil characteristics 

regulate water flow between infiltration, root-zone storage, deep percolation, and storm water runoff

(Christensen, 2002). Corn Belt soils are deep, fertile, and rich in organic material and nitrogen, and 

the land is relatively level. The warm nights, hot days, and well-distributed rainfall of the region 

during the growing season are ideal conditions for raising corn. Irrigation early in the season helps 

establish a uniform stand and water availability, whether by rainfall or irrigation during flowering is 

critical to achieve good seed set (Beck, 2004).

Corn grown for grain has substantially more irrigated area than any other single crop in the US, about 

10.6 million acres in 1997, but only about 15 percent of the total corn acreage is irrigated

(Christensen, 2002). Irrigated corn yields are about 29 percent higher than unirrigated corn yields. 

Irrigated corn is geographically distributed in the Corn Belt: eastern states irrigate only about 

3 percent of the total corn area, while western states irrigate about 50 percent (Christensen, 2002).

Insect Management

Management of insect pests typically employs multiple tactics, including cultural control, plant 

resistance, mechanical control, biological control, chemical control, and integrated pest management:

Cultural Methods: These are practices that alter farm procedures to make the agricultural 

environment unfavorable to insect growth or survival.

Crop Rotation. Crop rotation is one of the most utilized methods for rootworm management 

(Monsanto, 2011b) and is often the lowest cost tactic. Rotation with a non-grass crop reduces 

the levels of many pests through starvation or eliminating insect reproduction. Section 2.2.2.1, 

Cropping Practices, describes crop rotation practices.

Selection of Planting and Harvest Dates. Plant phenology can be manipulated to disrupt 

synchronization with the phenology of the pest insects. This can be achieved by either delaying 

or advancing planting dates. Early-planted corn has shown lower susceptibility to corn earworm 

(Helicoverpa zea) and southwestern corn borer (Diatraea grandiosella) damage than lateplanted crops (Boyd and Bailey, 2001); (Koul et al., 2004). The female D. grandiosella tends to 

lay fewer eggs on more mature plants and the plants have already passed their critical 

developmental stage. Early harvest often produces phenological asynchronies with a pest’s life 

cycle, allowing harvest before the damaging phase occurs. Early-planted corn can be harvested 
14

before many fully grown pre-diapause larvae have girdled the mature plants and caused yield 

losses through lodging of the plants (Koul et al., 2004).

Plant Resistance: Various physical or chemical attributes of a plant may have the ability to deter 

insects, to allow tolerance of their feeding or to kill them.

Hybrid selection. Hybrids vary in their ability to withstand and resist insect pests such as European 

corn borer. Rapid germination, early vigor, strong ear shanks, tight husks, resistance to stalk 

rots and other pests, strong stalks, and uniform performance over a wide population range are 

all factors influenced by hybrid genetics that may influence losses to insects (VanDuyn, 2005). 

Seedling insects, stalk borers, and ear feeding insects are most influenced by hybrid traits. Some 

hybrids have European corn borer resistance traits that reduce susceptibility to this pest 

(VanDuyn, 2005).

Transgenic Plants. Corn seed companies have developed a number of transgenic products that 

incorporate insect resistance traits, as described in Section 2.1, Corn Biology. These products, 

alone or in combinations with other traits (such as herbicide tolerance), provide corn growers 

with an additional tool to reduce damage by insect pests

Chemical Management: Insecticides can be used selectively through spot treatments by placing the 

chemical in the area occupied only by the pest to be controlled. This also helps protect non-target 

organisms and natural enemies. 

Natural Products and Selective Mechanisms. Recently developed insecticides are more selective 

in their toxicity spectrum than some older insecticides. For example, naturally derived products 

like Bacillus thuringiensis and spinosad affect only certain orders of insect pests and work only 

if they are ingested. Other products are selective because of the way they are presented to the 

pest. Imidacloprid, for example, works because it is absorbed and incorporated into the corn 

vascular system and selectively kills sucking insects such as corn leaf aphids, and the chinch 

bugs and southern corn leaf beetle (BASF-Corp., 2010). As a seed treatment, the chemical 

exposes only herbivorous insects, and not foraging insects (Lopez and Fernandez-Bolanos, 

2011).

Synthetic Chemicals. For rootworm, a variety of US-EPA restricted use pesticides are commonly 

available for larval control by in-furrow, post-plant or seed treatment (at least 7) and for adult 

control (at least 11) while for Western Bean Cutworm control, a grower may have at least 9 

choices (Krupke et al., 2011).

Mechanical Control: Tillage is able to reduce insect pest populations, by either exposing vulnerable 

stages to predation, or to dessication.

Corn Insect Control. Effects of tillage may be extremely variable in different fields or locations, 

and other environmental factors may also be relevant for effects. Rootworms are not much 

affected, but other important pests may be, such as wireworms, but these mostly are impacted 

when grassy weeds are large components of the managed field. Similarly tillage is important for 

black cutworm control in weedy situations (Hoeft et al., 2000).

Integrated Pest Management: IPM was introduced in the late 1960s and shifted the emphasis in 

pest control from a single-tactic, chemically based approach to a multi-tactic, economically based 

system (Intersociety-Consortium-for-Plant-Protection, 1979) (Koul et al., 2004).
15

Rootworm Control. Before the availability of rootworm resistant hybrids, growers increasingly 

turned to integrated pest management practices (IPM), which allow them to reduce energy 

use, environmental risk, and production costs while maintaining the quality of agricultural 

products and helping improve water, air, and soil quality. IPM is site-specific in nature, 

and includes prevention, avoidance, monitoring and suppression of weeds, insects, 

diseases, and other pests. IPM is site-specific in nature, and includes prevention, 

avoidance, monitoring and suppression of weeds, insects, diseases, and other pests. IPM 

includes insect scouting or monitoring to determine pest populations; applying compatible 

alternative biological, cultural, mechanical and chemical controls; and establishing action 

thresholds for agricultural inputs appropriate to the biology and ecology of the pest 

(Morallo-Rejesus and Rejesus, 1992) (Intersociety-Consortium-for-Plant-Protection, 

1979). Timely and targeted delivery of pest management interventions is key to successful 

IPM. As pesticide usage for control of rootworms declined and growers favored CRW

resistant hybrids, however, many decided that the crops did not require the same 

attentiveness to insect monitoring and to a coordinated mechanism for pest control (see 

(Gray, 2000); (Gray, 2011b); (Gray, 2011c), (Gray, 2011d).

Insect Pests of Corn. Corn is susceptible to attack by a variety of insects throughout its life cycle. 

Insects can be categorized as major and consistent pests, major and sporadic pests, and 

moderate to minor pests, based on annual destructiveness and their geographic distribution. 

The most economically significant corn pests include Diabrotica species (the corn rootworm 

complex) and Ostrinia nubilalis (European corn borer). The damage inflicted by rootworm 

larvae can significantly reduce grain yield by interfering with photosynthetic rates, limiting 

the uptake of water and nutrients, and by increasing the plant's susceptibility to lodging 

(Oleson et al., 2005). Lodging further reduces the effective grain yield by making the plants 

more susceptible to breaking, reducing their access to sunlight, and increasing the difficulty 

with which the grain can be harvested efficiently. Table 2: Corn Insect Pests lists corn 

insect pests found in the US in several corn growth stages. Among soil inhabiting insects, 

wireworms and white grubs are important pests (Hoeft et al., 2000) and important above 

ground principle pests are European and southwestern corn borer and corn earworm.
16

Table 2: Corn Insect Pests

Growth Stage Description of Damage Pests

From planting to full 

emergence

Seedlings are pulled up and eaten

Seeds are bored or completely hollowed 

out

Seedcorn maggots (Delia platura)

Seedcorn beetle (Stenolophus lecontei)

Wireworms (Melanotus spp.)

Emergence to knee-high 

corn

Stunting and wilting

Unnatural growth (stem twisting or 

excessive tillering)

Sandblasted leaves (leaves with speckled 

appearance)

Removal of plant tissue (chunks of leaves 

eaten, plants cut off near base, etc.)

White grubs (Cyclocarpa spp., Papillia 

japonica, Phyllophaga spp.)

Grape colaspis (Colaspis brunnea)

Chinch bug (Blissus leucopterus)

Black cutworm (Agrotis ipsilon)

Stink bugs, several species

Stalk Borer (Papaipema nebris)

Thrips, several species

Corn flea beetle (Chaetocnema ectypa)

Sod webworm, several species

Southern corn leaf beetle (Myochorus 

denticollis)

Billbugs, several species

Armyworm (Pseudaletia unipunctata)

Knee-high to tasseling corn Leaf tissues are removed (margin feeding 

or ragged holes in leaves, elongated 

lesions)

Stalks malformed (gooseneck growth)

Holes bored in the stalk

Corn rootworms (Diabrotica spp.)

Fall armyworm (Spodoptera frugiperda)

Grasshopper, several species

European corn borer (Ostrinia nubilalis)

Southwestern corn borer (Diatraea 

grandiosella)

Stalk borer (Papaipema nebris)

Tasseling to corn maturity Leaf tissue removed (chunks of leaf 

removed)

Stalks malformed or broken

Tassel damaged (tassel broken, eaten in 

whorl or discolored)

Silks clipped

Ear damaged (chunks of kernel removed, 

chewing damage, ear drop)

Fall armyworm

Grasshoppers

European corn borer

Southwestern corn borer

Corn rootworm (especially western corn 

rootworm)

Corn leaf aphid (Rhopalosiphum maidis)

Corn earworm (Helicoverpa zea)

Japanese beetle (Popillia japonica)

Source: Summarized from (O'Day et al., 1998).

Corn Rootworm - Biology, Feeding Behavior. Corn rootworms are important insect pests in the 

Corn Belt. There are at least four different corn rootworm taxa in the US: western corn rootworm 

(D. virgifera virgifera), the northern corn rootworm (D. longicornis barberi), the Mexican corn 
17

rootworm (D. virgifera zeae), and the southern corn rootworm (D. undecimpunctata howardi; also 

known as the spotted cucumber beetle; see Figure 3).

Western and northern corn rootworms have similar life cycles. Both have a single generation each 

year, and corn is the only economic host. In general, corn rootworms cannot complete their life cycle 

without the food supplied by corn plants. Beginning in July, females lay eggs in the soil at a depth of 

two to four inches near the base of the corn plant (O'Day et al., 1998).The eggs overwinter, and the 

onset of hatch ranges from late May to mid-June. Rootworm larvae feed on corn roots for three to 

four weeks, passing through three growth stages (instars). The second instar larvae are often the first 

detected because first instars are very small (only 1/16th of an inch long) (O'Day et al., 1998). 

Western and northern corn rootworm larvae feed first on roots near the soil surface; when these are 

consumed, the next lower node is attacked. First and second instars leave brown feeding scars 

(lesions) as they tunnel from root tips to the plant base, destroying root hairs and small roots. Third 

instars cause the majority of root damage and they generally feed on the large primary roots near the 

stalk. Larval corn rootworm injury results in yield losses in three ways:

1. Root pruning and tunneling disrupt nutrients and water transport from the root system;

during dry periods, when conditions suppress root generation, rootworm damage is 

amplified. 

2. Lack of root support causes goosenecking and lodging, which may limit sunlight capture by 

the plants and complicate harvesting; and

3. Root feeding promotes invasions by secondary pathogens such as bacteria and fungi which 

increase the incidence of corn rots (O'Day et al., 1998).

The Mexican corn rootworm has similar biology to the western corn rootworm (both are 

D. virgifera subspecies), but is primarily an economic pest in Texas (Rice, 2004). Additionally, 

adult corn rootworm beetles can cause silk clipping injury to corn plants, resulting in poor 

pollination and incomplete kernel set. Southern corn rootworm overwinters as an adult, and is not 

controlled by Bt-expressing hybrids (Alabama-Cooperative-Extension-System, 2012). This 

rootworm is mostly an economic pest in southern states and also infests the roots of many grass 

crops and weeds (North-Carolina-State-University, Undated).
18

 Source: Syngenta, 2011c. 

Corn Rootworm Management and Economic Losses. The corn rootworm genus includes some of 

the most damaging pests of corn. In the US, approximately 20 to 25 million acres of corn were once 

treated annually with soil insecticides to protect crops from feeding damage caused by corn 

rootworm larvae (Roehrdanz et al., 2003). Before corn rootworm-protected Bt corn varieties were 

introduced in 2003, an estimated 14 million acres were treated annually with conventional 

insecticides to control corn rootworms (Syngenta, 2011c); Appendix A of this EA). This translated to 

the annual application of more than 7.7 million pounds of insecticide active ingredient to corn fields 

for corn rootworm control (Syngenta, 2011c); Appendix A of this EA). Controlling Diabrotica

rootworms accounted for the largest single use of conventional insecticides in the US at that time. In 

2006 (prior to widespread adoption of transgenic crops for rootworm control), the USDA estimated 

Figure 3: Corn Rootworm Distribution Map
19

that corn rootworms caused $1 billion in lost revenue each year (USDA-ARS, 2006), which includes 

$800 million in yield loss and $200 million in treatment costs for corn growers (Fyksen, 2003).

Corn rootworm can be managed by crop rotation, insecticide application, and hybrid corn with 

rootworm resistance traits. Because basic biology of the pest may vary from region to region, 

management techniques may differ regionally. How the crop is grown may greatly affect the 

selection of management techniques. For example, about 29 percent of US corn acreage is not rotated 

but rather is planted to continuous corn (Gianessi et al., 2002). Until recently corn rootworm caused 

damage almost exclusively in fields where corn was grown at least two years in a row. In addition, 

new strains of corn rootworm have evolved that survive intervening years of a non-corn crop (Levine

and Oloumi-Sadeghi, 1991); (Gray et al., 2009). Corn producers have used crop rotation (usually 

with soybeans) to control corn rootworm, but this method has some economic and biological 

limitations.

Rotations in some growing areas have become less effective for several reasons. (1) A biotype of 

western corn rootworm (the western variant) has appeared in central Illinois, northern Indiana, and 

parts of Michigan that can lay eggs in soybean fields. The eggs hatch in the following season, 

coinciding with the corn rotation (Gray et al., 2009). This strain has spread rapidly since it was 

first observed in 1992. (2) A northern corn rootworm biotype (the northern variant) has exhibited 

extended diapause in which some eggs can survive through a non-corn rotation to attack corn in a 

subsequent season (Levine and Oloumi-Sadeghi, 1991). In South Dakota, Minnesota, Iowa, and 

Nebraska, the new northern corn rootworm biotype can diapause for two winters, which allows the 

eggs to bypass the rotated crop and hatch in time to feed on the next corn crop (Gianessi et al., 

2002). (3) Southern corn rootworm overwinters as an adult and has a varied diet, reducing the 

effectiveness of crop rotation in controlling this pest (Levine and Oloumi-Sadeghi, 1991); 

(Kuepper, 2002). Larvae of southern corn rootworm can attack more than 200 plant species, 

including soybeans.

Corn Rootworm Management with Chemicals. Chemical management of corn rootworm includes 

preventive seed treatments and in-furrow or banded soil applications. In mostly western parts of the 

Corn Belt, foliar applications are made later in the season for high populations of adult corn 

rootworm beetles; without control at that stage, increased rootworm egg deposition will presage 

increased larval rootworm on corn at that location in the next growing season. In areas where corn 

rootworm is common, growers basically treat routinely and prophylactically, not usually in response 

to scouting of insect pest populations (M. Gray in (Pocock, 2007).

Larval Control. The US-EPA has registered numerous insecticide products for the control of 

corn rootworm larvae (a list of representative products is available (Table C-1, Appendix C in 

Syngenta, 2011a). The insecticides used to control corn rootworm in conventionally grown 

corn consist mainly of organophosphates, carbamates, synthetic pyrethroids and phenyl 

benzyl classes of chemistry. The majority of these products are classified as Restricted Use.

Restricted Use Pesticides must be applied by a certified applicator or under the direct 

supervision of a certified applicator. The US-EPA requires application control measures for 

such insecticides to limit human and environmental exposure. Applying liquid or granular 

insecticide at planting-time in bands over the seed or post-planting basally to corn or overthe-row followed by soil cultivation is approved for rootworm control, as are delayed postplanting applications through chemigation (Kansas-State-University-Extension-Service, 

2011). In addition, GE corn seed generally is treated with systemic insecticides, such as 
20

neonicotinoids, and these kill rootworm larvae (Mullin et al., 2005) and also other seedattacking insects and some soil insects (Kansas-State-University-Extension-Service, 2011).

Much like resistance to crop rotation techniques, corn rootworm has developed resistance to 

some chemical insecticides (Meinke et al., 1998). Syngenta believes that “resistance to corn 

rootworm insecticides may result in increased chemical use” (because growers may attempt 

to control resistant insects with higher insecticidal doses) “and a greater dependence on 

insecticide” (because growers may use a different insecticide if the one to which resistance 

develops is no longer effective; (Syngenta, 2011c); Appendix A of EA). As discussed below 

in this section, resistance to ineffective plant incorporated protectants in CRW resistant 

hybrids could also cause the use of insecticides to increase.

Adult Control. Insecticides are used in control strategies for adult rootworm as well. In 

Kansas and Nebraska, and other parts of the western corn belt, insecticides are frequently 

used against adult rootworms (M. Gray, in (Grooms, 2009). At least 14 products can be used 

as foliar sprays to suppress adult egg laying, which would reduce the larvae present in next 

summer’s corn, if corn on corn rotation is the grower’s plan (Kansas-State-UniversityExtension-Service, 2011). Scouting abundance of adult insects needs to precede application, 

and to follow after it; if a second insecticide treatment is needed, “two sprays will often be 

more expensive that a single, planting-time application of a soil insecticide” (Kansas-StateUniversity-Extension, 1995). When adult numbers are high, silk clipping by rootworm adults 

before pollination can impact yields, and insecticides may also be applied with appropriate 

timing to forestall this potential for loss (Kansas-State-University-Extension-Service, 2011). 

Growers are encouraged to plant early since late-planted corn attracts emerging adults to 

pollinating corn. Increased progeny from these ovipositing females will impact the next 

season corn crop (Kansas-State-University-Extension-Service, 2011). However, very early 

planting (before April 18th in Kansas) can increase larval survival in insecticide treated 

furrows when eggs hatch occurs after degradation of the treatment (Kansas-State-UniversityExtension-Service, 2011). Corn planted late (June 1 in PA) can be damaged by adult feeding 

and inhibit pollination, and consequently require adult insecticidal treatment (Calvin, 2003).

Corn Rootworm Resistant Hybrids. Several varieties of transgenic rootworm-resistant corn have 

been developed by seed producers Field studies indicate that transgenic rootworm-protected corn 

provides as good as or better efficacy than soil insecticides in protecting corn roots from significant 

corn rootworm larval injury (Rice, 2004). In an Iowa study, transgenic corn hybrids were 100 percent 

effective in protecting roots from economic damage (i.e., damage that would result in yield loss), 

whereas the insecticide was only 63 percent effective and the untreated nontransgenic hybrid offered 

no protection from insect damage (Rice, 2004). Other trials indicate that location is relevant to 

results, so that in some sites and with some hybrids compared to the soil insecticide Aztec, hybrids 

alone did not show less damage or yield than the insecticide treatment (Tinsley et al., 2011).

Transgenic rootworm-protected corn for root protection, however, has greater convenience for 

growers than insecticide application, and protection does not rely heavily upon planting time, weather 

influences, calibration of application equipment, or soil conditions for optimum performance.

Replacing insecticides with transgenic plants has been shown to reduce the overall volume of 

insecticide used against the target pest. In the period from 1996 to 2008, the volume of active 

ingredients in insecticides (Brookes and Barfoot, 2010) for control of European corn borer and 

other lepidopteran pests (beginning in 1996) and corn rootworm (beginning in 2003). In 2008 
21

alone, the annual savings in the volume of applied insecticide active ingredient was 4 million 

kilograms (Brookes and Barfoot, 2010). Typical trials show that yield between insecticide treated 

non Bt cultivars and Bt-expressing cultivars are similar, so that need for such insecticides are 

replaced when rootworm-resistant hybrids are planted under low to moderate CRW pressure 

(Section 1, (Estes et al., 2011)).

The US-EPA requires refuges to minimize the potential for corn rootworms to develop resistance

(US-EPA, 2001); see a typical requirements in a BRAD, those for cry34/cry35 (US-EPA, 2005a). 

The refuge requirements are product-specific and range from 5 to 20 percent of each corn field.

The refuge can be a spatial one (percentage of the field area) or as a portion of the seed mix

(“refuge in a bag”), depending upon the specific product (US-EPA, 2007a). Varieties with multiple 

transgenic traits acting against a particular pest typically have smaller percentage requirements for 

refuges than single-trait products. Additionally the National Corn Growers Association promotes 

US-EPA mandated IRM strategies for all Bt corn varieties, including corn rootworm-protected 

cultivars, to minimize the potential for the insects to develop such resistance (NCGA, 2012).

When planting transgenic hybrids, the associated refuges cannot contain Bt expressing traits; 

growers may choose a method for chemical control of rootworm larvae (US-EPA, 2001) (Updated 

Feb 16`, 2011, section V. Bt Corn Confirmatory Data and Terms and Conditions of the 

Amendment). The need for insecticides in rootworm control should be determined from insect 

surveys done in August of the previous year (K. Ostlie, in Pocock (Pocock, 2007). Under low 

expected rootworm pressure, high dose seed treatment may provide sufficient protection. High 

rootworm populations the previous crop year may dictate that soil applied liquid or granular 

insecticides be used in the following year (Gray, 2011b), although extension staff often recommend 

granular formulas for better efficacy (M. Rice and M. Gray (Pocock, 2007).

Effects of Available Rootworm Resistant Hybrids on Integrated Pest Management. Crop 

entomologists note that to some extent, Bt crops have led to growers being less concerned about 

need for insect scouting to determine pest populations (Gray, 2000); (Ostlie, 2011a), or the need to 

consider and apply compatible alternative biological, cultural, mechanical and chemical controls

(Gray, 2011c). The economic value of responding to established action thresholds also may be 

unappreciated. Planting CRW resistant seed may be seen by some growers as simply ‘insurance’ 

against possible rootworm pressure (Wisconsin-College-Agric-Life-Sci., 2009). The unnecessary 

use of CRW-directed insecticides was similarly an issue as Gray (Gray, 2000) noted before 

widespread use of CRW resistant crops began. US-EPA also considers that IPM should be part of 

the IRM responsibilities of seed sellers and growers (see section D., Insect Resistance Management 

in (US-EPA, 2001)(Updated Feb 16, 2011), especially for decisions in the refugia.

Development of Resistance to Cry Proteins by Rootworm. Transgenic corn varieties may have 

limited potential to control corn rootworm if the insects develop resistance to these products. To 

delay evolution of resistance to transgenic crops producing Bt toxins, nearby refuges of corn plants 

not producing Bt toxins for control of the same pests are required by the US-EPA. The refuges 

promote survival of susceptible pests, which mate with resistant insects and slow the evolution of 

resistance (Tabashnik et al., 2008). Such refuges are expected to be most effective in slowing 

resistance when the toxin concentration in the adjacent Bt crops is high enough to kill all or nearly all

target insects (Meihls et al., 2008). 

The widespread use of transgenic Bt corn could generate selection pressures for insect resistance

(Tabashnik et al., 2008). Yield losses and corn lodging caused by rootworm pressure have been 

observed in limited areas of planted Bt-expressing hybrids and have been attributed to resistance
22

(Hodgson and Gassmann, 2011). The study indicates that the putative resistance of western corn 

rootworm was localized to areas of continuous corn, and the use of one Cry protein (Gassmann et al., 

2011). Discussed later in the Cumulative Impacts section, the potential for resistance to develop to 

any one product by low dose exposure can be limited by combining Bt proteins with different binding 

sites in the same plants (“pyramiding”) (Tabashnik et al., 2008). These varieties with multiple CRW 

resistant traits are presently available and are sold as part of multi-trait stacks in hybrids from several 

seed producers.

While rootworm damage to hybrids with CRW resistance occurs, significantly increased damage 

cannot be conclusively attributed to resistance. The presently deployed cultivars are not ‘high 

dose’ products and, under pressure of high populations of rootworm, could be expected to have these 

effects ((Monsanto, 2011a) ; (Gassmann et al., 2011); (US-EPA, 2010b). Failures to effectively 

control insect pests may be related to insufficiently high Cry protein concentrations in the transgenic 

crop (Tabashnik et al., 2008) and for Cry3Bb1 the consequences may only be apparent when hybrids 

are exposed to high populations of the pest. Possible CRW resistance to CryBb1 in multiple field

locations is presently being assessed by the seed developer (Monsanto, 2011a). Although unexpected 

damage to corn expressing Cry3Bb1 is known in at least four states, (Hodgson and Gassmann, 2011)

concluded that “the number of fields with resistance... is small at this time.”

Despite evidence of overwhelmed resistant hybrids, widespread failure of control measures using Bt

crops has not been observed, in part due to insect resistance management (IRM) strategies, including 

supplemental pesticide use and refuges (Tabashnik et al., 2008). In the case of Bt corn grown in the 

Corn Belt, refuge acres are typically 5 to 20 percent of the corn field area, depending on the product’s 

requirements (US-EPA, 2007a). Greenhouse and laboratory tests suggest that insects under intense 

selection pressure by Cry proteins over multiple generations may develop resistance rapidly in the 

absence of a refuge to sustain susceptible populations. These data in combination with the report of 

field resistance to a Bt product further emphasize the importance of effective refuges for resistance 

management (Meihls et al., 2008). Resistance management strategies, which are mandated by USEPA’s terms of Bt corn product registrations (US-EPA, 2001)(Updated Feb 16`, 2011, section V. Bt),

Corn Confirmatory Data and Terms and conditions of the Amendment) have been developed for all 

Bt corn products to mitigate the risk of pest resistance and to implement additional measures if 

resistance occurs.

Integration of Multiple Strategies. In most circumstances, a grower chooses either insecticides or a 

Bt- expressing corn hybrid for rootworm management. However, in some cases because of high 

pressure of rootworms in previous seasons, it may be advantageous for growers to use both (see 

recommendation of Monsanto (Monsanto, 2011a); see also Hodgson and Gassmann (Hodgson and 

Gassmann, 2011). Chemical companies have done field trials, sometimes with the cooperation of 

universities, to treat CRW resistant corn hybrids with conventional herbicides (e.g., Force 3G, 

Counter 15G, Fortress 5G, Aztec 4.67G), and in one series of trials have improved yields an average 

12 bushels per acre, and in another series, nearly 13 bushels per acre (Grooms, 2009). While an 

economic benefit was apparent in 70% of the field trial sites (J. Cecil, Syngenta (Grooms, 2009), the 

benefit could not be attributed to corn root worm control alone, but insecticide may have also 

controlled nematodes, wireworms and other grubs (Grooms, 2009). Application rates in these trials 

have been at 75% of that recommended for rootworm control at planting. In more recent 

comparisons in Illinois, but under low to moderate rootworm pressure, soil-applied insecticides rarely 

resulted in increased yield (Tinsley et al., 2011). Syngenta reports a trial of nearly 100 growers, who 

used conventional herbicide Force CS or Force 3G on a split plot design, in which one of three 
23

rootworm resistant lines were treated, one half with the insecticide, and one half not. In the typically 

high rootworm pressure areas of N. Illinois, N. Indiana and E. Iowa, growers obtained 10.9 bu/ ac in 

increased yield with insecticide (Syngenta, 2011b).

Despite the need for additional attentiveness to corn rootworm impacts, professional advice given to 

growers is that multiple tactics do not necessarily need to be employed simultaneously. Thus, 

University of Illinois Extension staff (Gray, 2011b) suggest that neither Bt-expressing corn hybrids 

with soil applied insecticides nor adult control the previous season before planting Bt hybrids should

become standard treatments. Rather, rotation of crops, alternation of Bt-expressing corn hybrids, 

insecticide use on conventional nonrootworm resistant crops, or using pyramided hybrids, and adult 

suppression should all be considered (Gray, 2011b). Grower decisions should be based on corn price, 

identification of fields with high CRW populations, trait performance at the location, and whether 

other soil pests are present. Long term perspectives for managing rootworm populations and other 

pests need to be taken, along with a fully integrated approach (Gray, 2011c). 

Disease and Other Pest Management

In addition to direct damage caused by feeding on plant tissue, insects play an important role in the 

transmission and dissemination of pathogenic organisms during corn development. Soil contains 

microorganisms, particularly fungi, that may infect plant parts injured by soil-dwelling insects. 

Primary roots of the seedling and the radical and seminal roots are commonly infected with Fusarium

species after the roots have served their function and become senescent. Feeding by corn rootworms 

has been associated with increased frequencies of Fusarium infection (Dicke and Guthrie, 1988);

rootworm feeding may also lead to increased incidences of stalk rots. These pathogen infections can 

reduce crop quality, harvestability, and yield.

Crop disease reduces both the quantity and quality of grain harvested. Disease loss estimates for 

corn production in the US range between 2 and 15 percent each year and reached 20 percent in 

1970 with the southern corn leaf blight epidemic (Jeffers, 2004). Losses estimated for diseases are 

difficult to determine because of (1) Variation in yield potential between different years (2) 

Differences in genetic background of germplasm being grown; and (3) Potential for unfavorable 

environmental conditions.

Major pathogens of no till corn in Iowa (Robertson et al., 2012 download) include Anthracnose, with 

leaf blight, top dieback, and stalk rot caused by the fungus Colletotrichum graminicola, eyespot 

disease, caused by the fungus Kabatiella zeae, Goss’s wilt caused by the bacterium Corynebacterium 

nebraskense with leaf symptoms, gray leaf spot caused by the fungus Cercospora zeae-maydis with 

leaf symptoms and secondary severe stalk rot and lodging and Northern corn leaf blight, caused by 

the fungus Helminthosporium turcicum, with leaf symptoms (For a complete list see Table C-2 in 

Appendix C, (Syngenta, 2011a) lists corn diseases, their pathogens, the conditions that favor the 

spread of disease, and current management practices. In addition, mycotoxins such as aflatoxins and 

fumonisins may accumulate in corn as it matures in the field, and inappropriate storage conditions 

may facilitate additional fungal deterioration and contribute to the accumulation of aflatoxins

(Rooney et al., 2004). A transgenic corn product has not yet been developed specifically to combat 

mycotoxins, although Bt corn used for control of ear-feeding lepidopteran pests has been shown to 

reduce the incidence of some mycotoxins in grain (Council-For-Biotech-Information, 2001). 

Minimizing insect damage through pest control measures such as Bt corn can reduce the incidence of 

fungal infection and accumulation of the associated mycotoxins.
24

Weed Management

Weeds compete with corn for light, nutrients, and water, especially during the first 3 to 5 weeks 

following emergence of the crop (Wright et al., 2009). Late-season weed infestations do not reduce 

corn yield nearly as much as early weed competition, but late-season weeds can harbor destructive 

insect pests. Competitive weeds include nightshade, smartweed, nutsedge, foxtail, velvetleaf, lambsquarters, pigweed, and waterhemp (Hager, 1998).

Some weeds can survive in crop production systems using herbicide-tolerant crops because of preexisting herbicide tolerance or because of growth habits or life cycles that help them avoid being 

treated, such as some winter annual weed species. Weed resistance management training to reduce 

the potential for weeds to develop tolerance to herbicides has been made available by the Weed 

Science Society of America in web-based training and other formats to growers and extension 

trainers and is readily accessible (Ohio-State-Extension, 2011). Industry practice includes weed 

resistance management training to reduce the potential for weeds to develop tolerance to herbicides

(four part training offered by National Corn Growers Association (NCGA, Undated).

Weed control methods differ depending on a number of factors. No single weed control regime is 

effective for all growing conditions. The management practices utilized by a grower will depend on 

the types of pests in their field, level of infestation, cropping system, type of soil, cost, weather, time, 

and labor. An integrated weed management program utilizes a combination of cultural (planting), 

mechanical (tillage), and chemical (herbicide) methods for consistent, effective weed control (Wright 

et al., 2009). USDA encourages integrated weed management beginning in 1990 with the in section 

1453 of the 1990 Farm Bill (7 U.S.C. 2801 et seq.) (USDA-AMS, 1996) because such management 

can help prevent the development of weed resistance to herbicides and the emergence of dominant 

weeds; controlling weedy and invasive plants is currently a program area priority with USDA’s 

NIFA competitive grants program, and this includes “integrated pest management, to manage and 

control weedy and invasive species” (USDA-NIFA, 2011).

In 2010, herbicide active ingredients were applied to 98 percent of acres planted to corn (USDANASS, 2011). The most widely used herbicide was glyphosate, applied to 66 percent of the planted 

acreage. Atrazine was applied to 61 percent of the planted acres and acetochlor was applied to 

25 percent of the planted acres. Between 1996 and 2009, the glyphosate rate of application per crop 

year may have risen 39 percent for corn according to projections by Benbrook (Benbrook, 2009)

although USDA-NASS surveys between 2005 and 2010 show only a 0.1 pound/acre increase in 

annual use rate (2010, 1.065 pounds glyphosate/a/yr, and no average increase in applications (USDANASS, 2006a); (USDA-NASS, 2011g). Overall herbicide (and plant growth regulator) usage

increased about 5% between 2005 and 2007 (US-EPA, 2011d). 

Herbicide-tolerant corn products have been genetically engineered to allow use of herbicides without 

harming the crop. Herbicide-tolerant corn has been widely adopted by growers in North America and 

offers enhanced weed control. In 2010, approximately 70 percent of the US corn crop was herbicidetolerant (USDA-ERS, 2011a). Currently available transgenic herbicide-tolerant corn cultivars include 

three glyphosate-tolerant cultivars and four glufosinate- (phosphinothricin) tolerant cultivars (USDAAPHIS, 2011b). However, over-reliance on herbicide-tolerant crops may under certain conditions 

contribute to the development of herbicide-tolerant weeds. Before glyphosate-tolerant crops were 

introduced, only three weed species in the world were known to have developed resistance to 

glyphosate (Knezevic, 2010). Glyphosate- or glufosinate-tolerant weeds now found in the US 
25

include common waterhemp (Amaranthus rudis), horseweed (Conzya sp.), giant ragweed (Ambrosia 

trifida), common ragweed (Ambrosia artemisiifolia), palmer amaranth (Amaranthus palmeri), hairy 

fleabane (Conzya conariensis), Italian ryegrass (Lolium multiflorum), rigid ryegrass (Lolium 

perenne), and Johnsongrass (Sorghum halpense) (Knezevic, 2010).

Herbicides are used in various ways in combination with tillage strategies. In no-till systems, the 

herbicide is applied directly to the last season's crop residue. In the other methods, soil is tilled before 

the herbicide is applied. The amount of herbicide used is somewhat independent of tillage method 

(US-EPA, 2009), although transgenic crops may facilitate no-till methods by reducing the need for 

soil application of herbicides. Common preplant herbicides might include metolachlor or atrazine, 

and post plant applications might include glyphosate for Roundup tolerant crops, along with other 

herbicides (Hartzler and Owen, 2006).

2.2.3 Specialty Corn Systems

Specialty systems include organic corn and specialty products such as white and waxy corn, sweet 

corn, and popcorn. These corn products comprise about 8 percent of the US corn market 2006

(USGC, 2006).

Organic Crop Production

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

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

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

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

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

methods from adjoining land that is not under organic management. Excluded methods, as defined 

by the USDA-NOP, may include the use of synthetic pesticides, fertilizers, and recombinant DNA 

technology found in GE crops. Organic production operations must also develop and maintain an 

organic production system plan approved by their accredited certifying agent. This plan enables the 

production operation to achieve and document compliance with the National Organic Standards, 

including the prohibition on the use of excluded methods. 

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

and practices used to produce or handle an organic agricultural product (7 CFR 205.300). This 

oversight includes an annual review of the certified operation’s organic system plan and on-site 

inspections of the certified operation and its records. Although the National Organic Standards 

prohibit the use of excluded methods (7 CFR 205.272), they do not require testing for the presence of 

excluded methods. Thus, NOP certification is dependent on process and not product. With regard to 

the unintentional presence of GE material in an organic product or operation, a recent USDA-AMS 

Policy Memorandum clarified that the unintentional presence of GE material will not affect the status 

of an organic product or operation when the operation has taken reasonable steps to avoid the 

products of recombinant DNA technology (USDA-AMS-NOP, 2011). However, retailers often 

require organic and non-GE farmers to verify their harvests through various tests (Ruth, 2003).
26

In 2008 (the most recent data available1), approximately 168,000 acres of certified organic corn were 

planted (for seed, grain, or silage) (USDA-NASS, 2010a ); Table 26), representing 0.20 percent of 

the 93.6 million acres of corn planted in the US that year (USDA-ERS, 2010a). The top states for 

harvested organic corn for grain or seed were Iowa, Wisconsin, Minnesota, Michigan and New York 

(AGMRC, 2010). Organic corn grown for grain or seed produced 15,749,401 bushels from 

143,432 harvested acres (USDA-NASS, 2010a ); Table 26), or an average of 109.8 bushels per acre. 

Insecticides Used in Organic Production. There are a number of insecticides approved for use in 

certified organic production systems, mainly non-synthetic compounds or biocontrols. Conditions for 

use of an insecticide must be documented under the National Organic Standard. The Organic Crops 

Workbook (ATTRA, 2003) lists the approved classes of insecticides used for organic production 

(Table 3) based on the USDA’s regulatory lists of approved and prohibited synthetic and nonsynthetic substances (USDA-AMS, 2007).

Table 3: National List of Approved Insecticides for Organic Production Systems

Class General Description Examples Notes

Botanicals Derived from plants pyrethrum, rotenone, 

sabadilla, neem

Strychnine and nicotine are also 

botanicals, but are expressly 

prohibited under the National List;

Rotenone, an insecticide approved 

for use in organic production, is 

highly toxic to fish.

Biologicals Insecticides containing 

disease organisms or toxins 

derived from disease 

organisms

Bacillus thuringiensis,

Beauveria bassiana,

Trichoderma 

harzianum,

Spinosad

Much like synthetic insecticides, 

insect pests have been observed to 

develop resistance to biological 

insecticides.

Spray Oils Vegetable or animal derived 

oils

Petroleum derived oils 

(narrow-range oils)

- Commonly used to control scale 

and mite pests

Insecticidal 

soaps

Fatty acid insecticidal soaps - Although synthetic insecticides, 

they are allowed in organic 

production;

May harm predatory mites

Minerals Mineral-based insecticides Sulfur, copper 

products, diatomaceous 

earth and kaolin clay

Natural minerals like arsenic, lead, 

and sodium fluoaluminate are 

prohibited;

Sulfur can reduce populations of 

beneficial insects;

Diatomaceous earth can cause 

respiratory problems in animals 

and humans

Pheromones Hormones used in products - -

 1 The USDA-NASS conducted a detailed survey of organic farming in 2008. USDA-ERS and USDA-NASS both prepare annual reports of 

overall crop production that do not provide as detailed information about organic farms. This summary therefore compares organic and nonorganic farming in 2008, using USDA-NASS and USDA-ERS data as cited.
27

called mating disrupters

Source: ATTRA, 2003 (ATTRA, 2003).

An integrated strategy (Hazzard and Westgate, 2004) for controlling selected insect pests in corn 

using organic practices might be comprised of:

1. Monitoring to determine pest pressure and need for treatment and, if necessary;

2. Direct treatment of each ear with a microbial or botanical insecticide carried in vegetable 

oil to control corn earworm;

3. Trichogramma releases and/or foliar applications of Bt or spinosad to control European 

corn borer; and/or

4. Foliar applications of Bt or spinosad for fall armyworm control.

Other Specialty Corn Production Systems

Approximately 8 percent of corn grown in the US is specialty corn, which includes sweet corn, 

popcorn, white, waxy, hard endosperm, high oil, non-transgenic, and organic corn (USGC, 2006). 

These corn varieties are specified by buyers and end-users of corn for production, and premiums are 

paid for delivering a product that meets purity and quality standards for the corn variety. Due to 

premiums offered by end-users and the dramatic adoption by U.S. farmers of GE corn varieties, 

specialty corn products are receiving increased attention as potentially profitable alternatives to the 

products of conventional and GE corn production systems (Elbehri, 2007).

Product differentiation and market segmentation in the specialty corn industry includes mechanisms 

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

(e.g., ISO9001-2000 certification), as well as contracts between growers and buyers that specify 

delivery agreements (Sundstrom et al., 2002). Systems used by specialty corn growers and end-users 

to maintain identity of the production include:

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

premiums for reaching goals and penalties for failing to attain specifications.

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

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

Quality Assurance Processes – oversight on handling procedures, testing planting seeds, and 

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

assuring testing procedures are appropriate.

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

products. This may also require that the end-user conduct intermediate procedures such as planting, 

providing oversight during the growing season, harvesting, and transportation to processing plant.

Identity Preservation Systems – using systems of identity preservation that have been shown to 

be successful in the past such as the seed certification systems conducted by members of the 

Association of Official Seed Certifying Agencies (AOSCA, 2011). To maintain the purity of the 

specialty corn product, this production system is based on controlling, tracking and documenting 

each step from seed production to end use (processing plants).
28

2.2.4 Raw and Processed Corn Commodities

Corn is processed to make it more palatable or isolate functional ingredients suitable for specific 

purposes (Orthoefer and Eastman, 2004). Dry or wet milling is used to separate the bran and germ 

from the endosperm; wet milling further separates the endosperm into its chemical components, 

principally starch and protein. Breeding and genetic engineering for certain traits have improved the 

concentrations of desired ingredients, but there are no differences in handling requirements for 

processing transgenic and non-transgenic corn except for certain products such as Syngenta’s alphaamylase (“Enogen”) corn, which requires special handling procedures to ensure that this corn is not 

used for unintended purposes (Syngenta, Undated).

2.3 Physical Environment

Water, soil, and air affect, and are affected by, corn agriculture; the methods described in 

Section 2.2.2, Agronomic Practices, may reduce some adverse impacts. This section describes water 

quality and use, soil characteristics, and air quality impacted by corn agriculture. Climatic conditions, 

in the context of potential climate change, are also discussed.

2.3.1 Water Quality and Use

Agriculture can affect water quality and use in irrigation. The following subsections describe corn 

agriculture’s impact to water quality and use.

Water Quality

Agricultural nonpoint source (NPS) pollution is the leading source of water quality impacts to rivers 

and lakes, the second largest source of impairments to wetlands, and a major contributor to 

contamination of estuaries and groundwater (US-EPA, 2005b). The primary cause of NPS pollution 

is increased sedimentation from soil erosion. Soil erosion can introduce sediments, fertilizers, and 

insecticides to nearby lakes and streams when they are carried from corn fields by rain or irrigation 

water (US-EPA, 2005b). Insecticides or their degradates have been detected in many of the nation’s 

streams (Gilliom et al., 2007) and agricultural stream sites in the Corn Belt have been documented 

with chemical herbicide concentrations that exceed the human-health benchmark established by the 

US-EPA (Gilliom et al., 2007).

Corn plant matter can be transferred to water bodies after field harvest, potentially accumulating in 

stream or lake sediments (Rosi-Marshall et al., 2007). There are no federal water quality standards 

for the insecticidal proteins present in transgenic insect-resistant plant varieties. Corn pollen may be 

deposited into water bodies adjacent to corn fields, contributing to turbidity or suspended solids. 

However, corn pollen is heavy and wind-borne pollen densities decrease rapidly from the source 

(Luna et al., 2001). Corn anthesis lasts for up to 14 days, and any pollen deposited into water bodies 

from adjacent fields during this period is unlikely to remain in suspension (Webster et al., 1999).

Certain agronomic practices, including conservation tillage methods and reduced fertilizer or 

insecticide application rates, may reduce adverse impacts. The US-EPA recommends (US-EPA, 

2008) several Best Management Practices for protecting water quality:
29

Conservation Tillage - leaving crop residue (plant materials from past harvests) on the soil surface 

reduces runoff and soil erosion, conserves soil moisture, helps keep nutrients and insecticides on 

the field, and improves soil, water, and air quality;

Crop Nutrient Management - fully managing and accounting for all nutrient inputs helps ensure 

nutrients are available to meet crop needs while reducing nutrient movements off fields. It also 

helps prevent excessive buildup in soils and helps protect air quality;

Pest Management - varied methods for keeping insects, weeds, disease, and other pests below 

economically harmful levels while protecting soil, water, and air quality; and

Conservation Buffers - from simple grassed waterways to riparian areas, buffers provide an 

additional barrier of protection by capturing potential pollutants that might otherwise move into 

surface waters.

Water Use

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

season, to produce one bushel of grain (SDCGA, 2010). Rainfall, stored soil moisture from 

precipitation before the growing season, and supplemental irrigation during the growing season 

provide water for corn, as described in Section 2.2.2.2, Irrigation. Supplemental irrigation was used 

on 12 million acres of corn fields in the US in 2008, reflecting 15 percent of all corn acres harvested 

for grain (Christensen, 2002). Groundwater is the major source for irrigation, used on almost 

90 percent of irrigated corn acreage in the US.

The total amount of water used by corn varies from season to season and location to location, and is 

dependent on temperature, humidity, soil fertility, wind, solar radiation, total leaf area of the crop and 

the interaction of these factors (Krantz, 2008). The typical water use by corn in the first 100 days 

after planting, as calculated from rainfall and irrigation, is illustrated in the graph in Figure 3.

 Source: Rhoades and Yonts, 2011.

Figure 4: Water Use by Corn Plant in the First 100 Days after Planting
30

Corn does not extract water uniformly throughout its rooting depth. Generally, more water is 

extracted from shallow depths and less from deeper depths. If water is applied to the soil surface, the 

typical extraction pattern follows the 4-3-2-1 rule: 40 percent of the water comes from the top 

quarter of the root zone, 30 percent comes from the second quarter, and so on (Krantz, 2008).

2.3.2 Soil

The interaction between the below-ground community of microorganisms and arthropods, plant-root 

structure, and organic residues in the soil is central to soil ecological processes including 

decomposing organic material, subsequent nutrient cycling and release, and maintaining soil structure 

and composition. Cultivating corn directly impacts these biological attributes. Agronomic practices 

such as crop type, tillage, and pest management regime have greater effects on the biology of the soil 

than the type of corn that is cultivated (Griffiths et al., 2007). For example, conventional tillage and 

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

prone to degradation. Soil degradation can lead to a decline in water quality and contribute to the 

greenhouse effect (Lal and Bruce, 1999). A decline in soil quality and soil resilience enhances the 

greenhouse effect through emissions of radiatively active gases (CO2, nitrous oxide [NOX]) (Lal and 

Bruce, 1999). Land that is prone to degradation is also more likely to adversely impact water resource 

quality and communities of organisms dependent on those water resources.

Conservation tillage methods including no-till, ridge-till, low-till and minimum-till leave a crop 

mulch on the ground to provide a protective cover to the soil between seasons and improve soil 

fertility by maintaining nutrient-rich organic matter on the field (NCGA, 2007);). Organic matter 

builds up in the soil, absorbing CO2 and helping to reduce a significant amount of greenhouse gas.

2.3.3 Air Quality

Air quality may potentially be directly affected by agricultural activities such as burning, tilling, 

harvesting, spraying, and fertilizing. Smoke from burning agricultural waste releases particulates. 

Tilling and harvesting with motorized equipment release emissions that include carbon monoxide, 

NOX, reactive organic gases, particulate matter, sulfur oxides, and greenhouse gases (GHG) (US-

(US-EPA, 2011b). Tillage also releases GHG because of the loss of CO2 to the atmosphere, and the 

exposure and oxidation of soil organic matter (Baker et al., 2005). Aerial application of insecticides 

may cause impacts from drift and diffusion. Insecticides may volatilize after application to soil or 

plant surfaces and move following wind erosion (Vogel et al., 2008). NOX may also be released 

following nitrogen fertilizer application (Aneja et al., 2009) . Agriculture, including land-use changes 

for farming, is responsible for an estimated 6 percent of all human-induced GHG emissions in the US

(US-EPA, 2011b). NOX emissions from agricultural soil management comprise 68 percent of all US 

N2O emissions (US-EPA, 2011b).

2.3.4 Climate

Corn agriculture may potentially affect or be affected by climate change (Isermann, 1994); (Aneja et 

al., 2009). Agriculture-related activities are recognized as both direct (e.g., exhaust from motorized 

equipment) and indirect (e.g., agricultural-related soil disturbance) sources of GHGs (US-EPA, 

2011b). Greenhouse gases collectively function as retainers of solar radiation and contribute to 

climate change. The agricultural sector is identified as the second largest contributor to GHG 

emissions in the US, ranking only behind the energy sector (US-EPA, 2011b).
31

Climate change may also potentially affect agricultural crop production. These potential impacts on 

the agro-environment and individual crops may be direct, including changing patterns in 

precipitation, temperature, and duration of growing season, or may cause indirect impacts 

extending the ranges of weeds and other pests (IPCC, 2007b). One recent study (IPCC, 2007a) of 

aggregate North American impacts on agriculture from climate change projects yield increases of 

5 to 20 percent for this century, while other data suggest a reduction in yields (Gillis, 2011). 

Certain regions of the US are likely to be more heavily impacted than others because water 

resources may be substantially reduced. North American production is expected to adapt with 

improved cultivars and responsive farm management (IPCC, 2007b).

2.4 Biological Environment

The biological environment described in this section includes animals, plants, biodiversity, and corn 

gene movement. Threatened and endangered species are discussed separately in Section 6.

2.4.1 Animals 

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

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

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

cover.

Bird species that have been observed in row crop fields include, among others, blackbirds (e.g., redwinged blackbirds (Agelaius phoeniceus), horned larks (Eremophila alpestris), brown-headed 

cowbirds (Molothrus ater), and vesper sparrows (Pooecetes gramineus) (Best and Gionfriddo, 1991). 

Specific bird species can act as beneficial or detrimental members in the agro-environment. For 

example, red-winged blackbird are often initially attracted to corn fields to feed on insect pests, but 

then also feed on the corn. Studies have shown that red-winged blackbirds can destroy more than 

360,000 tons of field corn and substantial amounts of sweet corn annually (Dolbeer, 1990). Although 

many birds visit row-crop fields such as corn, numbers are low and few nest there, likely due to 

overlap between nesting phenology and mechanized harvest (Johnson, 2000) (Patterson and Best, 

1996).

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

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

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

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

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

However, deer damage to large corn fields is often limited to a few rows closest to the wooded areas

(Neilsen, 1995). Raccoon damage to field corn has increased in recent years (Beasley and Rhodes 

Jr., 2008). In northern Indiana, Humberg (Humberg et al., 2007) attributed 87 percent of corn plants 

damaged across 100 corn fields over two growing seasons to raccoons. The deer mouse is the most 

common small mammal in some corn production regions (Stallman and Best, 1996; Sterner et al., 

2003) . Deer mice feed on a wide variety of plant and animal matter, but primarily feed on seeds and 

insects. They are considered beneficial in agro-ecosystems because they consume both weed and 

pest insect species. The meadow vole feeds primarily on fresh grass, sedges, and herbs, but also on 

seeds and grains. Meadow voles also can be considered beneficial for their role in the consumption 

of weeds, but can be an agricultural pest where abundant Smith (Smith, 2005). The thirteen-lined 
32

ground squirrel feeds primarily on seeds of weeds and available crops, such as corn and wheat

(Sterner et al., 2003; Smith, 2005). Thirteen-lined ground squirrels have the potential to damage 

agricultural crops, although they can also be considered beneficial when eating pest insects such as 

grasshoppers and cutworms.

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

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

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

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

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

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

2.4.2 Plants

Corn fields can be bordered by other agricultural fields (including other corn varieties), woodlands, 

or pasture and grasslands. From an agronomic perspective, the most relevant members of a 

surrounding plant community are those that can behave as weeds. Corn agronomic performance can 

be reduced by weed competition for water, nutrients, and light. US corn yields are threatened by 

more than 200 weed species annually (Heap, 2011).

Common corn field weeds include giant foxtail (Setaria faberi), giant ragweed, velvetleaf (Abutilon 

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

lambsquarters (Chenopodium album), Johnsongrass, fall panicum (Panicum dichotomiflorum), and 

hairy fleabane (Childs, 1996)(updated 2011). Weeds such as giant foxtail and barnyard grass

(Echinochloa crusgalli) have been shown to reduce corn yields by up to 14 (Fausey et al., 1997) and 

35 (Bosnic and Swanton, 1997) percent, respectively. Weed management strategies that corn growers 

use, including strategies to address weed resistance to herbicides, are discussed in 

Section 2.2.2.5, Weed Management.

2.4.3 Soil Microorganisms

Soil bacterial communities are influenced by plant species and cultivars as well as other 

environmental factors, such as soil type and agricultural practices (Icoz et al., 2008). Plant type and 

root exudates influence the microorganisms that colonize the rhizosphere (Icoz et al., 2008). While 

B. thuringiensis occurs naturally in soil, growing transgenic Bt corn increases the amount of Cry 

endotoxins present in agroecosystems (Blackwood and Buyer, 2004). Most proteins do not persist or 

accumulate in soil because they are inherently degradable in soils that have normal microbial 

populations (Burns, 1982). 

During the growth of the plant Cry protein concentrations within the rhizosphere vary and can be 

affected by microbial activity. In turn, growth of soil microbes depend in part on soil temperature 

and humidity (Baumgarte and Tebbe, 2005).The degradation of plant biomass is also accompanied 

by changes in the numbers of microorganisms and the activity of some enzymes involved in the 

process. Thus, microbial populations differ significantly by season, probably as a result of 

differences in the water content of soils, ambient temperatures, and plant stage growth at the time of 

sampling (Icoz et al., 2008).
33

2.4.4 Biodiversity

Biodiversity within agricultural ecosystems is strongly impacted by agricultural practices, including 

the type of cultivated plant and crop-specific management practices. Species diversity and abundance 

in corn agro-ecosystems may differ between transgenic, non-transgenic, and organic corn. Relative to 

any natural ecosystem, species abundance and richness will generally be less in intensively managed 

agroecosystems.

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

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

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

numerous studies, conflicting results are often reported. Different studies have demonstrated 

decreases in biological diversity or abundance due to GE crops engineered to accumulate insecticidal 

proteins or tolerate herbicide application for weed management (Ponsard et al., 2002). Alternatively, 

other studies of GE crops, such as Bt corn, when compared to non-GE crops sprayed with 

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

(Chen et al., 2008); (Pioneer, 2009) ; (Romeis et al., 2006) ; (Torres and Ruberson, 2005); 

(Wolfenbarger et al., 2008). Some reports show that GE crops may even increase biological diversity 

in agro-ecosystems (Marvier et al., 2007); (Romeis et al., 2006). Herbicide-tolerant corn, when 

compared to non-GE corn production, may not result in changes in arthropod abundance and may 

increase species diversity during different times of the year (Brooks et al., 2003); (Hawes et al., 

2003), (Roy et al., 2003). Since biological diversity can be defined and measured in many ways, 

APHIS considers determining the level of biological diversity in any crop to be complex and hard to 

achieve concurrence. Another difficulty with biodiversity studies is separating expected impacts 

from indirect impacts. For example, reductions of biological control organisms are seen in some Btexpressing GE crops, but are caused by reduction of the pest host population following transgenic 

pesticide expression in the GE crop plant.

2.4.5 Gene Movement in the Natural Environment

Corn is self-compatible and wind-pollinated. Unlike other grass species in the U.S. (Wipff and Fricker, 

2002b; Watrud et al., 2004), there are no native plant species that can be pollinated by corn pollen without 

human intervention (e.g., chromosome doubling or embryo rescue) (Galinat, 1988); (Mangelsdorf, 1974); 

(Russell and Hallauer, 1980). However, teosinte (wild progenitor of corn) can sometimes be found as 

introduced populations in botanical gardens and as feral populations of Zea mexicana in Florida, 

Alabama, Maryland (USDA-NRCS, 2011) and Zea perennis in South Carolina (USDA-NRCS, 2011a; 

USDA-NRCS, 2011b) . Feral populations of the closely related and sexually compatible subspecies of Z. 

mays spp. parviglumis have also been described in a single county (Miami-Dade) of Florida Pioneer 2009 

(Pioneer, 2009). Evidence of introgression of genes from corn into U.S. teosinte populations has not been 

sought but complex mechanisms of incompatibility have been described that are barriers to this 

potentiality (Kermicle and Evans, 2010).

2.5 Public Health

Public health concerns related to corn stem from human consumption of corn and corn products, 

animal (livestock) consumption of feed corn and corn products, and the indirect effect on human 

health and worker safety from laborers’ exposure to agricultural chemicals.
34

2.5.1 Human Health

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

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

sweeteners have risen from 35.3 pounds annually per capita in 1980 to 69.2 pounds in 2008 (USCB, 

2011). During the same time period, the share of corn that is genetically engineered has risen from zero 

to 80 percent (USDA-ERS, 2010; USDA-ERS, 2010a; USDA-ERS, 2011a). 

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

they market are safe and properly labeled. Food and feed derived from any GE crop must be in 

compliance with all applicable legal and regulatory requirements. GE organisms for food and feed may 

undergo a voluntary consultation process with the FDA prior to release onto the market. Although a 

voluntary process, applicants who wish to commercialize a GE variety that will be included in the food 

supply invariably complete a consultation with the FDA. In a consultation, a developer who intends to 

commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, 

nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a 

summary of its scientific and regulatory assessment of the food; FDA evaluates the submission and 

responds to the developer by letter. 

As noted by the National Research Council (NRC), unexpected and unintended compositional changes 

arise with all forms of genetic modification, including both conventional hybridizing and genetic 

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

characterized due to additional rigor in regulatory requirements (König et al., 2004). The NRC also 

noted that at the time, no adverse health effects attributed to genetic engineering had been documented 

in the human population. More recently, the NRC stated that GE crops have had fewer adverse effects 

on the environment than non-GE crops (NRC, 2010). Reviews on the nutritional quality of GE foods 

have generally concluded that there are no significant nutritional differences in conventional versus GE 

plants for food or animal feed (Faust, 2002); (Flachowsky et al., 2005); (König et al., 2004).

Corn has no known human health risks except allergenicity. The Food Allergen Labelling and 

Consumer Protection Act (2004) requires disclosure of the presence of eight specific food groups which 

are designated as “major food allergens” on the package labels (US-FDA, 1992). These eight food 

groups (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybean) account for 

90 percent of food allergic reactions in the (US-FDA, 1992). Corn is not designated as a “major food 

allergen” and the FDA guidance on compliance with the Act does not include reference to corn or 

refined corn products (Corn-Refiners-Association, 2006). There are no known human health effects 

from the novel proteins in Bt corn.

At present, the prevalence of corn food allergy in the US is exceedingly low, estimated to affect no 

more than 0.016 percent of the general population (Corn-Refiners-Association, 2006). Exposure to 

corn allergens can occur externally (direct skin contact) or internally (ingestion). Some attributed 

symptoms of corn allergy include dermatitis, asthma, urticaria, migraine headache, ulcerative colitis, 

irritable bowel disease, celiac sprue, and anaphylaxis under severe exposure (US-FDA, 1992). 

Currently there is no cure for corn allergy. The only mechanism for managing the hypersensitivity is 

to avoid consuming foods that contain the allergen.

Additional impacts of Bt crops on human health. Certain Bt corn cultivars can reduce mold 

infestation on corn grain (Carpenter et al., 2002); Section 1). One study found that transgenic hybrids 
35

with cry genes for lepidopteran resistance had fumonisin concentrations as low as 10 percent of those 

found in non-transgenic counterparts (Munkvold et al., 1999). Any reduction in mold toxins resulting 

from use of Bt corn can provide direct benefits to people and corn-fed livestock by reducing exposure 

to mycotoxins. In a variety of field studies, lepidopteran-protected corn varieties expressing Bt 

proteins have been shown to have significantly lower levels of the common mycotoxins that are 

produced by fungal pathogens (Wu, 2006b).

2.5.2 Animal (Livestock) Health

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

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

feed would also be GE (USDA-ERS, 2011a). 

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

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

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

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

for feed may undergo a voluntary consultation process with FDA before release onto the market, 

which provides the applicant with any needed direction regarding the need for additional data or 

analysis, and allows for interagency discussions regarding possible issues.

Corn has no known animal (livestock) health risks except from the presence of mycotoxins, which 

are secondary metabolites produced by certain fungi. Mycotoxins are considered unavoidable 

contaminants in food as there is no known technology that can completely eliminate their presence in 

crops. Insect damage is one factor that predisposes corn to mycotoxin contamination, as insect 

herbivory creates stalk or kernel wounds that encourage fungal colonization (Wu, 2006a). 

Mycotoxins are of concern worldwide because of their toxic and carcinogenic effects in humans and 

animals feeding on infected corn. Table 2-5 provides a list of corn mycotoxins; the two categories of 

most concern are fumonisins and aflatoxins.

Fumonisins are found exclusively in corn, while aflatoxins are found in a variety of crops including 

corn, cotton, peanuts and some nuts (Wu, 2006a). Fumonisins are produced by the fungi Fusarium 

verticillioides and F. proliferatum. Since their first discovery in 1988, over 28 types of fumonisins 

have been isolated, of which fumonisin B1 (FB1) is the most common in corn (Wu, 2006a). 

Fumonisins can be highly toxic to animals, causing diseases such as leukoencephalomalacia in horses 

and pulmonary edema in swine (Wu, 2006a). Lepidopteran-protected Bt corn hybrids have reduced 

fumonisin levels (Munkvold et al., 1999).

Aflatoxins are produced by the fungi Aspergillus flavus and A. parasiticus, and are the most potent 

chemical liver carcinogens (Wu, 2006b). In poultry, aflatoxin consumption results in liver damage, 

impaired productivity and reproductive efficiency, decreased egg production in hens, inferior 

eggshell quality, inferior carcass quality, and increased susceptibility to disease (Wu, 2006b). In 

cattle, the primary symptoms are reduced weight gain, liver and kidney damage, and reduced milk 

production (Wu, 2006b). One analysis of Bt on corn at harvest shows that these mycotoxins may be 

present at half the level as that of transgenic isoline corn (Abbas et al., 2008); review showed that the 

performance of bt hybrids however, seemed dependent upon heat stress and insect damage (Reddy, 

2009). Extensive testing and use have identified no animal (livestock) health risks for transgenic 

corn products expressing Bt proteins (Shimada et al., 2008).
36

Table 4: List of Corn Mycotoxins Toxic to Animals Consuming Contaminated Feed

Mycotoxin Fungi Associated Symptoms/Toxicology

Aflatoxin Aspergillus flavus, A. parasiticus liver necrosis, liver tumors, reduced 

growth, depressed immune response, 

carcinogen

Fumonisin Fusarium moniliforme, F. proliferatum equine leukoencephalomalacia, porcine 

pulmonary edema

Deoxynivalenol F. graminearum feed refusal, reduced weight gain, 

diarrhea, vomiting

Trichothecenes F. graminearum, F. culmorum, F. poae alimentary toxic aleukia, necrosis, 

hemorrhage, oral lesion in broiler 

chickens

Ochratoxins Penicillium verrucosum, Aspergillus ochraceus porcine nephropathy; various 

symptoms in poultry

Citrinin Penicillium spp., Aspergillus spp kidney damage

Cyclopiazonic acid Penicillium spp., Aspergillus spp. Neurotoxin

Sterigmatocystin Aspergillus spp., and others carcinogen, mutagen

Source: Koennig and Payne, 1999; pg. 4.

2.5.3 Worker Safety

Workers engaged in corn production may encounter insecticides, herbicides, fungicides or fertilizers 

that may pose a worker health or safety risk unless used in accordance with the US-EPA -established 

agriculture-specific requirements in the Worker Protection Standard (US-EPA, 1992) that protect 

field workers from the hazards of chemical exposure. The Occupational Safety and Health 

Administration requires all employers to protect their employees from hazards associated with 

agricultural chemicals.

Pesticides are used on most corn acreage in the US, and changes in acreage, crops, or farming 

practices can affect the amounts and types of pesticides used and thus the risks to workers. Registered 

pesticides, including the representative products listed in Table C-1 (in Appendix C, (Syngenta, 

2011c)) must have use restrictions that, if followed, have been determined to be protective of worker 

health.

2.6 Socioeconomic

Corn agriculture can affect socioeconomic resources such as the domestic economy, international 

trade economy, and the social environment. This section describes key current issues within each of 

these topics.

2.6.1 Domestic Economic Environment

Domestic demand for corn in the US comes from its use for feed, ethanol production, food, and seed, 

and totaled 11.1 billion bushels in the 2009/2010 marketing year (USDA, 2011b). Exports (as 

described in Section 2.7.2, Trade Economy) added another 2 billion bushels to total US corn demand. 
37

Demand is satisfied almost entirely by domestic supply with few imports, the US being largely a net 

exporter of corn. In the 2009/2010 marketing year, feed was approximately 40 percent of US corn 

production; food, seed, and industrial uses were approximately 45 percent (including ethanol 

production, at about 36 percent), and exports the remaining 15 percent (USDA, 2011b).

US corn farms have increased cash receipts from $34.1 billion in 2007 to a projected $62.0 billion in 

2011, representing an increase from 22.7 percent of the US crop market to 30.0 percent (USDA-ERS, 

2011c). Annual cash receipts for corn as compared to all crops are shown in Table 5.

Table 5: Corn and Crop Cash Receipts

Year

Cash Receipts ($ billions)

Corn All Crops

2007 34.1 150.1

2008 48.4 175.0

2009 42.5 168.3

2010 44.8 172.9

2011 62.0 206.5

Source: USDA-ERS, 2011c; pg. 1.

Net returns for corn farmers fluctuated between $125 and $200 per acre from the mid-1990s until the 

mid-2000s, but more than doubled in price to nearly $400 per acre in the late 2000s (USDA-ERS,

2011b). Net returns are expected to remain near $350 per acre for the next decade. USDA-ERS 

attributes the recent increase and projected future high prices to ethanol demand, in part due to the 

renewable fuel standard component of the Energy Policy Act (Energy Policy Act of 2005). The recent 

average annual market price of corn in the (USDA-NASS, 2011d) has been relatively high, due in 

part to the ethanol demand:

• 2008-- $4.06/bushel

• 2009-- $3.55/bushel

• 2010-- $5.40/bushel

There is a niche market for non-transgenic food and feed in the US, as is evident from private 

labeling initiatives such as the Non-GMO Project. This initiative offers third-party product 

verification and labeling for non-transgenic products.2 There also is a niche market for organic 

products in the US. Sales of organic products have been growing quickly, from $1 billion in 1990 to 

$26.7 billion in 2010, with a 7.7 percent increase between 2009 and 2010 alone (OTA, 2011). To 

satisfy the demand for organic corn, producers have had to adopt specific production practices to 

maintain and prevent the use of excluded methods as dictated by the NOP. To offset the increase in 

investment related to these more extensive practices, premiums are often paid for non-transgenic or 

organic corn. For example, August 2011 non-organic corn in the US averaged $6.88 per bushel

(USDA-NASS, 2011e).

Grower selection of strategies for corn rootworm management is dependent upon the price received 

for corn, so that when the corn is highly valued, then additional strategies can be chosen. While corn 

price remained in the $2/bushel range from 2002-2006, use of soil applied insecticide attained to 

about 25 million acres (GfK Kynetic Market Research, database inquiry in, Syngenta 2011

 2 See Non-GMO-Project website: http://www.nongmoproject.org/.
38

(Syngenta, 2011b) or about 31% of the planted crop. As the price of corn increased between 2006 

and 2008 to $3-5/bushel, this coincided with increasing choice of rootworm resistant hybrids, 

reaching about 35 million acres or 38% of planted acres in 2008 (GfK Kynetic Market Research, 

database inquiry in, Syngenta, 2011 (Syngenta, 2011b) while 10% of planted acres continued to use 

insecticide application for larval root worm control. As the price of corn approaches $6/bushel, 

treatment for expected high rootworm populations with both a Bt trait hybrid and soil insecticide 

such as Force G or Force CS can increase the yield 10.9 bushels/acre and result in a possible $65/acre 

gain for growers (see Syngenta, 2011 (Syngenta, 2011b). The yield increase may be caused not only 

by increased corn rootworm control, but also of secondary pests such as wireworms, and Japanese

beetle larvae (Syngenta, 2011b).

2.6.2 Trade Economic Environment

Agribusiness is one of the world’s largest industries, employing 1.3 billion people and producing 

$1.3 trillion worth of goods each year (Shelton et al., 2002). The US is the largest world exporter of 

corn, averaging nearly 50 million metric tons per year between 1990 and 2010 (USDA, 2011b). US 

corn exports within the last decade peaked at 61 million metric tons in 2007/08 (USDA-ERS, 2009b). 

In 2010, the total value of US corn exports was nearly $8 billion (USDA-ERS, 2011d). During the 

last half decade, the US share of world corn exports averaged 60 percent; the second largest exporter 

is Argentina. Japan is the world’s largest corn importer, typically followed by South Korea, Mexico, 

Egypt, and Taiwan (USDA-FAS, 2011).

The primary US corn export destinations are also the largest world importers of corn and do not have 

major barriers for importing transgenic products. Data on international trade in organic corn are not 

readily available but trade in organic corn is likely to be a very small share of the total corn trade.

The USDA Interagency Agricultural Projections Committee forecasts near-term production increases 

for grain products in general, in response to recent global supply-and-demand conditions (USDA, 

2011b). Prices are projected to decline globally in the short term as production expands. Steady 

growth in production and historically high prices are projected long term, through 2020. Assuming 

that current subsidies and tariffs remain in effect, corn is expected to remain the primary feedstock 

for US ethanol production, comprising about 36 percent of the total corn use.

2.6.3 Social Environment

Social issues related to corn include farmer and consumer choice, as well as the structure of US corn 

farms. Farmers have a range of options in agronomic practices, seed products (non-transgenic, 

transgenic, and organic), and markets for their products. Consumers have a range of corn products to 

choose from in a free market system such as the US.

Genetic engineering has exerted a downward pressure on food prices by increasing agricultural 

productivity. Relatively lower food prices presumably allow consumers to choose between a greater 

variety of products that are now more affordable. Transgenic crops can positively contribute to

sustainability for farmers. Traits such as herbicide tolerance and insect resistance, as described in 

Section 2.2, Corn Production, offer opportunities for making agriculture more sustainable (Franke et 

al., 2011). The advent of the NOP in the US has also increased consumer choice, as is evident by the 

rapid growth of the organic market segment (see Sections 2.2.3.1 and 4.2.2.1).
39

US corn farms and their operators are similar in many respects to those of other feed grain crops. 

According to data from the 2003 Agricultural Resource Management Survey (ARMS), the majority 

of feed grain farms (84 percent) raised corn (Hoffman et al., 2007); overall feed grain data are 

therefore generally applicable to corn farms when grain-specific data are not available. Feed grain 

farms operate more acres per farm, have higher gross and net incomes per farm, and have higher 

values of farm equity per farm than nonfeed grain farms. Feed grain operators were much more likely 

to list farming as their occupation and were more likely than operators of nonfeed grain farms to 

operate a farm organized as a partnership or family corporation (Hoffman et al., 2007). Only 

29 percent of all feed grain farms specialized in feed grains, but those farms accounted for 51 percent 

of all feed grain production, and most of the specialized farms were corn farms (Hoffman et al., 

2007).

In 2003, feed grain farms’ average annual net cash income was $45,916, compared to $8,875 for 

nonfeed grain crops (Hoffman et al., 2007). The ratio of cash expense to gross cash income was 

75 percent for feed grain farms, compared to 85 percent for nonfeed grainfarms (Hoffman et al., 

2007). The total household income (from all sources) for corn farm operators averaged about $70,000 

in 2003, nearly $10,000 above the US average household income that year but nearly equal to the 

average income from nonfeed grain farm families (Hoffman et al., 2007). Off-farm income sources 

include off-farm employment, investment income, pensions, Social Security payments, and gifts 

(Hoffman et al., 2007). Additionally, there are four types of government payments to feed grain 

operators: direct; counter-cyclical and loan deficiency; conservation reserve, wetland reserve, and 

environmental quality incentives program payments; and other (Hoffman et al., 2007). For corn 

operators, these programs contribute some 15 percent of their cash income. Direct government

payments accounted for about 8 percent of average gross cash income for corn farms in 2003 

(Hoffman et al., 2007) while the other three categories comprised another 7 percent of cash income 

for corn farmers (Hoffman et al., 2007).
40

3 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of 5307 corn. To respond favorably to a petition for nonregulated status, APHIS 

must determine that 5307 corn is unlikely to pose a plant pest risk. Based on its PPRA USDAAPHIS, 2011), APHIS has concluded that 5307 corn is unlikely to pose a plant pest risk. Therefore 

APHIS must determine that 5307 corn is no longer subject to 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act. 

Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated status 

of 5307 corn. APHIS has assessed the potential for environmental impacts for each alternative in the 

Environmental Consequences section.

3.1 No Action Alternative: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. Event 5307 corn and progeny 

derived from 5307 corn would continue to be regulated articles under the regulations at 7 CFR part 

340. Permits issued or notifications acknowledged by APHIS would still be required for 

introductions of 5307 corn and measures to ensure physical and reproductive confinement would 

continue to be implemented. APHIS might choose this alternative if there were insufficient evidence 

to demonstrate the lack of plant pest risk from the unconfined cultivation of 5307 corn. 

This alternative is not the Preferred Alternative because APHIS has concluded through a PPRA that 

5307 corn is unlikely to pose a plant pest risk (USDA-APHIS, 2011). Choosing this alternative 

would not satisfy the purpose and need of making a determination of plant pest risk status and 

responding to the petition for nonregulated status. 

3.2 Proposed Action: Determination That Event 5307 Corn Is No Longer a Regulated 

Article

Under this alternative, 5307 corn and progeny derived from them would no longer be regulated 

articles under the regulations at 7 CFR part 340. Event 5307 corn is unlikely to pose a plant pest risk 

(USDA-APHIS, 2011). Permits issued or notifications acknowledged by APHIS would no longer be 

required for introductions of 5307 corn and progeny derived from this event. This alternative best 

meets the purpose and need to respond appropriately to a petition for nonregulated status based on the 

requirements in 7 CFR part 340 and the agency’s authority under the plant pest provisions of the 

Plant Protection Act. Because the agency has concluded that 5307 corn is unlikely to pose a plant 

pest risk, a determination of nonregulated status of 5307 corn is a response that is consistent with the 

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

regulatory policies in the Coordinated Framework.

3.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for 5307 corn. The agency evaluated 

these alternatives, in light of the agency's authority under the plant pest provisions of the Plant 

Protection Act, and the regulations at 7 CFR part 340, with respect to environmental safety, efficacy, 

and practicality to identify which alternatives would be further considered for 5307 corn. Based on 

this evaluation, APHIS rejected several alternatives. These alternatives are discussed briefly below 

along with the specific reasons for rejecting each.
41

3.3.1 Prohibit Any Event 5307 Corn from Being Released

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

marketplace, APHIS considered prohibiting the release of 5307 corn, including denying any 

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

given that APHIS has concluded that 5307 corn is unlikely to pose a plant pest risk (USDAAPHIS, 2011).

In enacting the Plant Protection Act, Congress found that 

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

[the Plant Protection Act] shall be based on sound science...§ 402(4).

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

White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

implementation of policies for oversight of emerging technologies (such as genetic engineering) at 

the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563 and, consistent with that Executive Order, the following principle, among others, to 

the extent permitted by law, when regulating emerging technologies: 

“[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandates of 

each agency” 

Based on the PPRA (USDA-APHIS, 2011) and the scientific data evaluated therein, APHIS 

concluded that 5307 corn is unlikely to pose a plant pest risk. Accordingly, there is no basis in 

science for prohibiting the release of 5307 corn.

3.3.2 Approve the Petition in Part

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

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

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

concluded that 5307 corn is unlikely to pose a plant pest risk (USDA-APHIS, 2011), there is no 

regulatory basis under the plant pest provisions of the Plant Protection Act for considering approval 

of the petition only in part. 

3.3.3 Isolation Distance between Event 5307 Corn 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 5307 corn from conventional or specialty corn

production. However, because APHIS has concluded that 5307 corn is unlikely to pose a plant pest 

risk (USDA-APHIS, 2011), an alternative based on requiring isolation distances would be 

inconsistent with the statutory authority under the plant pest provisions of the Plant Protection Act 

and regulations in 7 CFR part 340. 
42

APHIS also considered geographically restricting the production of 5307 corn based on the 

location of production of non-GE corn in organic production systems or production systems for 

GE-sensitive markets in response to public concerns regarding possible gene movement between 

GE and non-GE plants. However, as presented in APHIS’ PPRA for 5307 corn, there are no 

geographic differences associated with any identifiable plant pest risks for 5307 corn (USDAAPHIS, 2011). This alternative was rejected and not analyzed in detail because APHIS has 

concluded that 5307 corn does not pose a plant pest risk, and will not exhibit a greater plant pest 

risk in any geographically restricted area. Therefore, such an alternative would not be consistent 

with APHIS’ statutory authority under the plant pest provisions of the Plant Protection Act and 

regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordinated 

Framework.

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

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

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

the Plant Protection Act. However, individuals might choose on their own to geographically 

isolate their non-GE corn production systems from 5307 corn 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 5307 corn is available from 

Association of Official Seed Certifying Agencies (AOSCA, 2011).

3.3.4 Requirement of Testing for Event 5307 Corn

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

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

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

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

and maintain. Additionally, because 5307 corn does not pose a plant pest risk (USDA-APHIS, 

2011), the imposition of any type of testing requirements is inconsistent with the plant pest 

provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology 

regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a 

requirement for 5307 corn would not meet APHIS’ purpose and need to respond appropriately to 

the petition in accordance with its regulatory authorities. 

3.4 Comparison of Alternatives

Table 6: Summary of Environmental Consequences 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 6: Summary of Environmental Consequences

Resource

Alternative

No Action

Preferred Alternative: 

Determination of 

Nonregulated Status

Corn Production

Production and Yield Unchanged Unchanged

Agronomic practices Unchanged Unchanged
43

Specialty Corn systems Unchanged Unchanged

Raw and processed corn commodities Unchanged Unchanged

Physical Environment

Water quality and use Unchanged Unchanged

Soil Unchanged Unchanged

Air quality Unchanged Unchanged

Climate Unchanged Unchanged

Biological Environment

Animals Unchanged Unchanged

Plants Unchanged Unchanged

Soil Microorganisms

Biodiversity Unchanged Improved

Gene movement in the natural environment Unchanged Unchanged

Public Health

Human health Unchanged Unchanged

Animal (livestock) health Unchanged Unchanged

Worker safety Unchanged Improved

Socioeconomics

Domestic economic environment Unchanged Improved

Trade economic environment Unchanged Unchanged

Social environment Unchanged Unchanged
44

4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential environmental consequences addresses the potential impact to the human 

environment from the alternatives analyzed in this EA, namely taking no action and a determination 

by the agency that Event 5307 corn does not pose a plant pest risk and therefore should no longer be 

regulated under 7 CFR 340. Potential environmental impacts from the No Action Alternative and the 

Preferred Alternative for 5307 corn are described in detail throughout this section. A cumulative 

impacts analysis is presented in Chapter 5. The agronomic characteristics of this product and its 

cultivation would not differ under the alternatives except the phenotype of rootworm tolerance 

selected for this product, and the comparisons aredescribed below.

4.1 Scope of Environmental Analysis

The scope includes any land in the U.S. currently producing corn, any land that is currently 

producing crops that could incorporate a corn rotation, as well as land that could be converted from 

inactive cropland to active cropland, and land currently in the Conservation Reserve Program (CRP) 

that could be removed from the program and farmed. Conversion of grassland, forest, or other land 

types to cropland as a result of a determination of nonregulated status of 5307 corn would be less

likely because these types of conversions have not been notable contributors to cropland over the past 

18 years; therefore, APHIS does not consider them to be part of the affected environment in this EA. 

To determine areas of corn production, APHIS used data from the National Agricultural Statistics 

Service (NASS) (USDA-NASS, 2011a) ; (USDA-NASS, 2011c). Corn grain was commercially 

produced in all states except Alaska. However, the majority of the corn produced in the U.S. is 

cultivated in the states of Illinois, Iowa, Indiana, the eastern portions of South Dakota and Nebraska, 

western Kentucky and Ohio, and the northern two-thirds of Missouri (USDA-ERS, 2011b); (USDANASS, 2011c), (USDA-NASS, 2011a). Iowa and Illinois, the two top corn producing states, 

typically account for slightly more than one-third of the total U.S. corn crop (USDA-ERS, 2011h).

Other Assumptions

The environmental consequences of the different alternatives described above will be analyzed 

under the assumption that farmers, who produce conventional corn, 5307 corn, or produce corn 

using organic methods, are using reasonable, commonly accepted best management practices for 

their chosen system and varieties during agricultural corn production. However, APHIS 

recognizes that not all farmers follow these best management practices for corn. Thus, the 

analyses of the environmental affects will also include the assumption that some farmers do not 

follow these best management practices.
45

4.1.1 Persistence in the Environment/Weediness Potential

Syngenta assessed agronomic categories that are associated with persistence in agricultural 

environments, or with changes in status that might be associated with weediness. For the 5307 

cultivar Syngenta assessed seed germination and dormancy, growth characteristics, reproductive 

capability, seed dispersal, and interactions with abiotic stressors and biotic stressors. The 5307 

cultivar was compared to suitable control plants (see section VII.a.2, (Syngenta, 2011c) and no 

biologically meaningful differences were observed. Syngenta 5307 is no more likely to be weedy 

or invasive than the parental cultivar.

4.2 Corn Production

This section describes the potential impacts to agronomic practices, specialty corn systems, and raw 

and processed corn commodities that may result from the No Action and Preferred Alternatives.

4.2.1 Production and Yield

Acreage and Areas of Corn Production

The amount of transgenic corn planted in the US indicates an increasing trend. Of the total corn acres 

planted in 2011, 88 percent were transgenic varieties (USDA-NASS, 2011d), up from 61 percent in 

2006 (USDA-NASS, 2006a). As described in Section 2.2.1, Production and Yield, most increases in 

corn production are expected to be a result from yield growth rather than increases in planted areas, 

although corn acreage is expected to vary between 2011 and 2020 by about 2 percent (USDA-ERS, 

2011f) likely deriving from acreage converted from other crops and not new production acreage. 

Substantive changes in corn production acreage and areas are more likely to result from changed 

market conditions and new federal policies than from any other source.

Arable land for increased corn planting acreage could result from the return of CRP lands to 

agricultural production. The 2008 US Farm Bill (Food, Conservation, and Energy Act of 2008,

(FCEA) reduced CRP lands from 39.2 million acres to 32 million acres (FCEA; Section 2103, 

Paragraph (3)). Available acreage for corn production could increase by this federal policy change. 

The conversion of CRP acres, if it were to occur, would be independent of the adoption of 

transgenic corn products; in the period between 2011 and 2020, USDA-ERS predicts however, that 

CRP acres should remain around 32 million acres (USDA-ERS, 2011f).

No Action Alternative

The acreage and areas of corn production are not likely to change as a direct or indirect result of the No 

Action Alternative. Regulated field trials of 5307 corn would only impact small plots of land with no 

effect on the acreage and areas of corn production. Conventional production practices that use 

transgenic varieties would likely continue to increase, based on current acreage trends. Current trends in 

the acreage and areas of production are likely to continue to be driven by market conditions (i.e.,

increased demand for US corn and corn products for animal feed, ethanol, etc. ) and federal policy even 

if 5307 corn continues to remain a regulated article. It is anticipated that seed with transgenic traits and 

non-transgenic hybrids would continue to be available under the No Action Alternative. Corn is 

currently produced in 49 states (all states but Alaska, according to the 2002 Census of Agriculture ) and 

under the No Action Alternative, the range of production would be unchanged. The USDA ERS does 
46

not predict any net increases in CRP acreage converted to corn production between 2012 and 2019

(USDA-ERS, 2011f), and so CRP acreage would not be affected by this alternative.

Preferred Alternative

Consistent with the demonstrated lack of agronomic difference and other considerations, acreage and 

areas of corn production are expected to be unchanged under the Preferred Alternative. Overall 

impacts would be similar to the No Action Alternative. A determination of non-regulated status of 

5307 corn would provide growers with an alternative to other transgenic corn rootworm-protected 

varieties that are currently available.

Agronomic characteristics of Event 5307 corn are similar to other corn varieties currently available 

and grown in the U.S.; there were no statistically significant differences in most agronomic traits 

between 5307 corn and a non-transgenic, near-isogenic control hybrid (Syngenta, 2011c) Syngenta 

studies identified small but statistically significant differences in grain moisture, plant height, the 

number of heat units to 50 percent pollen shed, and grain yield (Syngenta, 2011c). However, there 

were no observed deficits in agronomic performance of 5307 corn.

The acreage and areas of corn production are not likely to change as a direct or indirect result of the 

Preferred Alternative. In 2011, transgenic corn accounted for 88 percent of all corn acres in 

production in the US and, as noted above, the use of transgenic corn seed has been increasing. In the 

period 2006-2008, most corn growers increased corn acreage at the expense of acreage typically 

planted to other crops and only 2% converted CRP lands to corn production (USDA-ARS (Wallander 

et al., 2011)). However, with an increase in price of $1 per bushel, increasing replacement of CRP 

acres could occur, and economic models generally agree with this forecast (Gill-Austern, 2011). A 

determination of nonregulated status of 5307 corn is not expected to alter the range of corn 

cultivation as the new transgenic trait (rootworm resistance) does not otherwise change the plant’s 

agronomic performance compared to non-transgenic varieties (Syngenta, 2011c).

Growers are not expected to change the acreage or areas of corn production as a result of a 

determination of nonregulated status of 5307 corn. This alternative would not result in new acreage 

removed from CRP set-asides for corn production if previous trends continue (Wallander et al., 

2011) because the traits will not change corn characteristics, and corn acreage is not expected to 

significantly increase between 2012 and 2017 (USDA-ERS, 2011f). However, as earlier noted, if 

corn prices increase by $1 per bushel or more, then CRP acres can be predicted to be converted by 

growers for corn production (Gill-Austern, 2011). Current trends in the acreage and areas of corn 

production are likely to continue to be driven by market conditions and federal policy if 5307 corn 

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

Plant Protection Act. 

4.2.2 Agronomic Practices

Crop Rotation and Tillage

Crop rotations are used to optimize soil nutrition and fertility, and reduce pathogen loads. As 

described in Section 2.2.2, Cropping Practices, crop rotation is an effective measure for controlling 

corn rootworm, although in some areas variant rootworm populations display behavioral changes that 

circumvent rotation strategies. Some northern corn rootworm populations have an extended diapause 

that allows eggs to hatch when the crop rotation returns to corn rather than in the non-corn rotation 
47

crop in the growing season that follows corn. A variant western corn rootworm population now lays 

its eggs in soybean fields rather than corn fields, allowing eggs to hatch in fields rotating to corn.

Tilling the soil reduces weeds that would otherwise crowd or compete with the corn crop. (US-EPA, 

2009). Until recently, conventional tillage was commonplace, using moldboard plows prior to 

planting followed by secondary tillage (Allmaras, et al., 1997 in (US-EPA, 2009)). Reduced or 

conservation tillage methods have largely replaced conventional methods. Reduced tillage uses chisel 

plows and results in less soil disturbance. Conservation tillage also uses chisel plows and includes notill and focused methods such as strip, ridge, or mulch tillage. The intensive plowing of conventional 

tillage results in less than 15 percent crop residue (unharvested plant material); reduced tillage is 

associated with 15 to 30 percent crop residue; and conservation tillage is associated with at least 30 

percent crop residue and substantially less soil erosion than other tillage practices (US-EPA, 2009). 

Conservation tillage methods have been increasingly favored by growers for reducing soil water loss 

and promoting decreases in soil loss. Because of its low cost and positive impact on soil quality, 

conservation tillage is currently and widely practiced in the Midwestern US (see map, USDA-NRCS,

(USDA-NRCS, 1999), showing substantial parts of corn belt states with 40-60% and 60-90% 

conservation tillage) 

No Action Alternative

Cropping practices, including crop rotation and tillage are not likely to change as a direct or indirect 

result of the No Action alternative. Cropping practices are likely to continue to be driven by market 

conditions even if 5307 corn continues to remain a regulated article. The current economics of corn 

production are driving the change or perceived change in crop rotation practices. Growers make 

choices to plant certain corn varieties and use certain crop rotation practices based on factors such as 

yield, weed and disease pressures, cost of seed and other inputs, technology fees, worker safety, 

potential for crop injury, and ease and flexibility of the production system (Olson and Sander, 1998),

1988; (Gianessi, 2005). Under the No Action Alternative, the demands and price of corn would 

continue to depend on the market for field corn, and corn-to-corn rotations would continue to be used 

by farmers if this cropping practice meets the economic and marketing strategy for the particular 

farmer. Regulated field trials of 5307 corn would only impact small plots of land with no effect on 

cropping practices.

Changes in rotation practices are more likely to result from market conditions than other factors. A 

recent increase in corn-to-corn rotations has been attributed to the increase in corn prices due to 

higher demand, driven primarily by ethanol production (Hart, 2006); (Vyn, 2006). In fact, corn-oncorn rotation was used prior to the increase in corn for ethanol production (Erickson and LowenbergDeBoer, 2005). Corn-on-corn rotations may provide a continual host environment for some insects 

and diseases. However, in a farm on a corn-soybean rotation, continuously growing corn for multiple 

seasons can decrease populations of soybean pests, such as soybean cyst nematode. In some areas, 

corn-on-corn rotation has increased levels of fertilizer inputs (Sawyer, 2007).

Tillage practices are unlikely to change under the no action alternative. Tillage practices will likely 

remain as it is practiced today by the farming community.
48

Preferred Alternative

Overall impacts would be similar to the No Action Alternative. A determination of non-regulated 

status of 5307 corn would provide growers with an alternative to other transgenic corn rootwormprotected varieties that are currently available. Cropping practices such as rotation are not likely to 

change as a direct or indirect result of the Preferred Alternative. Although high dosage corn 

rootworm-resistant products could potentially reduce pressure on corn, effective corn rootwormmanagement for all corn will still require crop rotation as a frequent component for integrated insect 

control and also to limit development of resistance (Gray, 2011c); (Gray, 2011d); Syngenta 5307

appears not significantly more effective than other CRW traits (Hibbard et al., 2011). Stacking with 

two or more rootworm specific proteins is likely to support better rootworm management. US-EPA

asserted that current simulation models “strongly suggest that pyramided PIPs are superior to the 

current single trait CRW products” (US-EPA, 2009a). Despite a potential relaxation of a need for 

rotation in CRW control, other benefits of crop rotation (e.g., increased yield, benefits to soil, farm 

economics) would remain and could be more important to the grower than convenience of continuous 

corn production. 

The current economics of corn production are driving changes in crop rotation practices as farmers 

seek the most profitable production method. Corn-on-corn (“continuous corn”) is used by some 

growers in response to market demands and expectations of higher economic returns (Erickson and 

Lowenberg-DeBoer, 2005); (Malcolm et al., 2009). A determination of nonregulated status of 

5307 corn would not change the price of corn commodities in the US because prices would continue 

to be set by market demand. A determination of nonregulated status of 5307 corn would not likely 

affect a farmer’s decision to initiate crop rotation, or to increase the overall use of corn-on-corn 

rotation as a cropping strategy with the US farming community, since in the first case, the overall 

decision for tillage type may be a global one, with many inputs constraining choices (see Thomason, 

2009), and in the second case, a predominantly economic benefit governs the grower choices 

(Erickson and Lowenberg-DeBoer, 2005).

A determination of nonregulated status of 5307 corn would not directly or indirectly impact tillage 

practices, because APHIS makes the assumption that growers have previously optimized these 

practices for maximizing their economic return and in consideration of relative benefits for specific 

soil or other physical and environmental conditions on their farm operation (examples of the tillage 

considerations corn growers must make are summarized in (Thomason et al., 2009). Growing Event 

5307 corn would not require any different agronomic approaches than with similarly available corn 

varieties.

Irrigation

As described in Section 2.2.2, Irrigation, supplemental irrigation is used in some corn production 

areas, such as the western portion of the Corn Belt during the growing season and during flowering. 

Irrigation rates are affected by local climate conditions (seasonal rainfall), and climate change could 

increase or decrease irrigation rates in some areas.

No Action Alternative

Irrigation practices are not likely to change as a direct or indirect result of the No Action Alternative. 

Irrigation rates are likely to continue to be driven by climate conditions. Regulated field trials of 

5307 corn would be relegated to small plots of land with no effect on irrigation rates.
49

Preferred Alternative

Consistent with the demonstrated lack of agronomic difference, overall impacts of a determination of 

nonregulated status of 5307 corn would be similar to the No Action Alternative. A determination of 

non-regulated status of 5307 corn would provide growers with an alternative to other transgenic corn 

rootworm-protected varieties that are currently available. Irrigation practices would not change as a 

direct or indirect result of the Preferred Alternative. The damage inflicted by corn rootworm larvae 

can significantly reduce grain yield by interfering with photosynthetic rates and by limiting the 

uptake of water and nutrients (Syngenta, 2011c) . Reducing rootworm-caused damage would only 

affect plant water efficiency, and not irrigation rates. Similar to the no action alternative, irrigation

rates would continue to be dependent upon climate and weather conditions. Because the eCry3.1Ab 

protein prevents the negative physiological impact of root pruning by rootworms, 5307 corn may 

allow more efficient use of water and fertilizer (Syngenta, 2011c); Appendix A of the EA).

Insect Management

As described in Section 2.2.2, Insect Management, corn growers use a variety of methods, including 

applying restricted use chemical pesticides (specifically, insecticides), to control insect pests. Broadspectrum insecticides may impact agriculturally important non-target organisms (US-EPA, 2005), 

including beneficial insects such as honeybees or insects that prey on other insects. Before the 

introduction of Bt-derived corn varieties, the tools available to growers for insect control consisted of 

insecticide applications, agronomic practices, and, to a limited extent, the use of corn varieties with a 

degree of native pest resistance. Bt-derived products have a limited activity spectrum and affect only 

certain orders of insect pests. Bt-derived products are active only if they are ingested and activated by 

certain organisms, and they are selective because only organisms with gut receptors that bind specific 

Bt proteins are affected. Use of broad-spectrum or Bt-derived insecticides, however, can result in 

insects developing resistance to the insecticide.

The introduction of the first Bt corn varieties in 1996 provided growers with an effective means of 

limiting damage caused by the European corn borer. Prior to the introduction of corn rootwormprotected Bt corn varieties in 2003, an estimated 14 million acres were treated annually with 

conventional insecticides to control corn rootworms. This equated to applications of more than 7.7

million pounds of insecticide active ingredients annually in corn fields for the control of Diabrotica

species (Ward et al., 2005). Control of Diabrotica spp. accounted for the largest single use of 

conventional insecticides in the US at that time.

Transgenic varieties for corn rootworm control are as effective, or more effective, than chemical 

insecticides used for rootworm control (Gianessi, 2005); (Tinsley et al., 2011). Available data 

indicate that broad-spectrum insecticide use in corn agriculture has declined since the introduction of 

insect resistant corn varieties. Some estimates indicate that reductions in chemical insecticide use on 

the order of 70 percent (Oehme and Pickrell, 2003) to 75 percent (Rice, 2004) could result from 

widespread adoption of corn rootworm-protected varieties. For example, insecticide use for corn 

rootworm control could be reduced by over 5 million pounds per year if 10 million acres of 

transgenic corn were planted (compared to approximately 92 million acres of corn planted in the US 

in 2011) (Rice, 2004).

Increased adoption of corn rootworm-protected corn products may have certain environmental 

benefits because many of the restricted use chemical insecticides registered for corn rootworm 

control present a certain level of potential risks to applicators, other agricultural workers, and 
50

wildlife. The soil-applied and foliar chemical insecticides for larval and adult corn rootworm control 

were subject to the greatest use reductions following the adoption of transgenic rootworm-protected 

corn varieties and include organophosphates, carbamates, pyrethroids, and pyrazoles (Vaughn et al., 

2005). Adoption of additional rootworm-protected corn varieties is not expected to markedly reduce 

the use of insecticidal seed treatments used to control other soil pests such as wireworms and grubs; 

when used for corn rootworm control, these seed treatment products are applied at a lower rate (e.g., 

Cruiser 5FS (Syngenta, 2010a). Using soil-applied granular insecticide formulations, application

rates for both types of pests may not differ (e.g., Force 3G (Syngenta, 2010b)). 

Corn rootworm populations have developed resistance to some insecticides and to non-chemical 

control methods.3 Resistance to some corn rootworm insecticides may result in increased chemical 

use (US-EPA, 2010b; US-EPA, 2010e). As an alternative, crops engineered to produce Bt toxins that 

target specific pest taxa have had favorable environmental effects, particularly when replacing 

broad-spectrum insecticides (NRC, 2010); (Carpenter, 2011). Insect-resistant transgenic corn, 

including stacked-trait varieties with herbicide tolerance, accounted for 65 percent of corn acres 

planted in 2011 (USDA-ERS, 2011a).

Rootworm-protected Bt corn hybrids have been available to US growers since 2003. The current PIP 

proteins registered for corn rootworm control in field corn are Cry3Bb1 (in MON 863 and 

MON 88017), Cry34Ab1/Cry35Ab1 (in DAS 59122-7), and mCry3A (in MIR604). As the industry 

trend is towards combined-trait hybrid offerings, these Cry proteins are available in multiple 

combinations. From the perspective of preventing or mitigating resistance in target pest populations, 

the deployment of multiple corn rootworm traits in a single corn hybrid may benefit the durability of 

the registered PIPs in corn.

No Action Alternative

Trends in insecticide use are not likely to change as a direct or indirect result of the No Action 

alternative. Corn production, and pesticide use in corn, would remain as it is practiced today by the 

farming community. Insecticide use rates are likely to continue to decline even if 5307 corn continues 

to remain a regulated article, as growers will continue to have access to existing insect-resistant corn 

varieties that are no longer subject to the requirements of Part 340 and the plant pest provisions of the 

PPA. Growers make choices to use certain pesticides based on weed, insect and disease pressures, 

cost of seed and other inputs, technology fees, fuel costs, worker safety, potential for crop injury, and 

ease and flexibility of the system (Olson and Sander, 1998); (Gianessi, 2005).

Any environmental effects as a result of pesticide use in the agricultural production of corn would 

remain the same under the No Action Alternative. The availability of other corn rootworm-resistant 

varieties would continue if 5307 corn continues to remain a regulated article. Corn growers are likely 

to continue to use the wide spectrum of available conventional pesticides or any of the four other 

corn rootworm-resistant cultivars that are currently available, as listed in Table 2-1, Transgenic Corn 

Cultivars Containing Bt-derived Proteins with Nonregulated Status. Regulated field trials of 

5307 corn would only impact small plots of land with little effect on insecticide use.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

 3 Arthropod populations having pesticide resistance are listed on Arthropod Pesticide Resistance Database.
51

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Corn growers would have a new corn rootworm-control option to use in addition to the three other 

corn rootworm-resistant Cry proteins that are currently available, as listed in Table 2-1, Transgenic 

Corn Containing Bt-derived Proteins with Nonregulated Status. Similar to the no action alternative, 

trends in reducing insecticide use are likely to continue.

Similar to the no action alternative, there is concern about the ability of corn rootworms to evolve 

resistance to control mechanisms that include crop rotation, chemical insecticides, and rootwormprotected Bt corn products. As 5307 corn has demonstrated efficacy against corn rootworm and the 

eCry3.1Ab protein may have a different mode of action from that of at least one other CRW specific 

Bt (Walters et al., 2010). Consequently, 5307 corn may extend the useful life of other commercially 

available corn rootworm-protected Bt corn cultivars (i.e., containing Cry3Bb1, Cry34Ab1/Cry35Ab1 

or mCry3A). However, the activity of the 5307 CRW toxin is not strictly additive with that of 

pyramided MIR604 lines in field trials or in reports of other combinations of CRW targeted Bts 

(Hibbard et al., 2011). Nevertheless, the availability of eCry3.1Ab as an additional tool for rootworm 

control could also reduce the selection pressure on rootworm populations to develop resistance to 

other methods of pest control. As noted earlier in the Affected Environment section, if more efficacy 

is available through new CRW resistance traits, the need by growers for augmenting their use of 

CRW resistant traits with insecticides declines, and the applications of restricted use pesticides would 

be avoided. 

Similar to the no action alternative, the widespread use of transgenic Bt corn could generate selection 

pressures on insects for resistance to the plant-incorporated protectants (Tabashnik et al., 2008). To 

combat this type of resistance, the US-EPA requires refuges to minimize the potential for corn 

rootworm to develop this type of resistance. The refuge requirements are product-specific and range 

from 5 to 20 percent of each corn field, and can be spatial (percentage of the field area) or as a 

portion of the seed mix (“refuge in a bag”), depending upon the specific product (US-EPA, 2007a). 

Varieties with multiple transgenic traits acting against a particular pest typically have smaller 

percentage requirements for refuges than single-trait products. Additionally the National Corn 

Growers Association promotes US-EPA mandated IRM strategies for all Bt corn varieties, including 

corn rootworm-protected cultivars, to minimize the potential for the insects to develop such 

resistance (NCGA, 2012). Some corn with the earliest developed CRW resistance trait (Cry3Bb1) 

has begun to show unexpected damage by rootworm, but apparently these low- or moderate-dose 

products have been placed under stress by grower noncompliance with refuges (extension surveys, 

(University-of-Illinois, 2011)), and planting of continuous corn has been an extensive local pattern 

(Gassmann et al., 2011). Nonetheless, insect resistance to Bt crops has not caused widespread failure 

of control measures, in part due to insect resistance management (IRM) strategies, requirements for 

growers to plant refuges of crop varieties lacking similar Bt traits and including pesticide use in these 

refuges and supplemental use on CRW resistant hybrids in some circumstances (Tabashnik et al., 

2008). No evidence suggests that the control failures are affecting other CRW resistance traits at 

higher frequency (Cry 34/35, (Ostlie, 2011b), or MIR 604, (Hibbard et al., 2011), (Gassmann et al., 

2011).

Disease and other Pest Management

Crop disease reduces both the quantity and quality of grain harvested. Disease loss estimates for corn 

production in the US range between 2 and 15 percent each year and reached 20 percent in 1970 with 

the southern corn leaf blight epidemic. Losses estimated for diseases are difficult to determine 

because of (1) Variation in yield potential between different years (2) Differences in genetic 
52

background of germplasm being grown; and (3) Potential for unfavorable environmental conditions.

Estimates of corn yield loss caused by pathogens have ranged from 2 to 17 percent (Smith and White, 

1998) ; (Jeffers, 2004).

No Action Alternative

If APHIS does not determine that the Event 5307 has been shown to be appropriate for nonregulated 

status, continued planting of the variety in test plots will have no impact on disease management. 

Currently deployed strategies will continue to be used by growers, both for the test plots and in the 

vicinity of standard crops near test sites.

Preferred Alternative

Availability of the Event 5307 corn will have no impact on disease management issues. .Disease 

resistance traits will continue to be an option chosen frequently by growers as needed in their area, 

since these are made available as nontransgenic traits commonly incorporated into local commercial 

offerings.

Weed Management

Yield losses in all crops due to weeds, diseases, and insects were substantial and widespread until the 

introduction and adoption of crop protection chemicals in the 1950s (Wheeler, 2002). Weeds 

compete with crops for light, nutrients, water, and other growth factors. If weeds are left 

uncontrolled, corn cannot be grown economically. 

No Action Alternative

If APHIS does not determine that the Event 5307 has been shown to be appropriate for nonregulated 

status, continued planting of the variety in test plots will have no impact on weed management or of 

disease management. Currently deployed strategies will continue to be used by growers, both for the 

test plots and in the vicinity of standard crops to test sites.

Preferred Alternative

Availability of the Event 5307 corn will have no impact on pest management issues, either of weeds 

or of diseases. Growers will choose either stacked varieties of 5307 corn with herbicide tolerance 

and manage the crops with herbicides exactly as they do with varieties not expressing the CRWresisting protein, or make use of other methods of weed control. 

4.2.3 Specialty Corn Systems

Organic Crop Production

Certified organic corn acreage is a small but increasing percentage of overall corn production. The most 

recent data indicates that the certified organic corn acreage in 2008 was approximately 195,000 acres, 

representing 0.21 percent of the total field corn acreage (USDA-ERS, 2010a) in the US. This was an 

increase of nearly 50 percent from the 131,000 acres in organic corn production in 2005, which 

represented 0.16 percent of the total field corn acreage that year. Comparatively, transgenic corn 

accounted for 80 percent of the 87.3 million acres of field corn planted in 2008, (USDA-NASS, 2008b)

about 69.8 million acres. That number represents an increase in plantings for transgenic corn since 2005, 
53

when transgenic corn accounted for 52 percent of the 81.6 million acres of field corn planted that year 

(USDA-NASS, 2005), about 42.4 million acres.

Organic corn growers may benefit from transgenic crops grown nearby. Reducing populations of 

insect pests in transgenic crop fields can help lower population pressure in adjacent fields, organic or 

not, as is evident from economic analyses of avoided costs. For example, one study found that 

cumulative yield losses from Bt corn-suppressed European corn borer that would have occurred if the 

populations had remained at historic levels have been valued at over $4.3 billion in a 5-state region 

over 14 years (Hutchison et al., 2011) . Such area-wide pest suppression could conceivably occur 

following sustained use of rootworm-resistant corn varieties, thus resulting in benefits to organic corn 

growers.

Organic farming operations, as described by the NOP and administered by the USDA-AMS, must 

have distinct, defined boundaries and buffer zones between adjoining land not under organic 

management to prevent unintended contact with prohibited substances (7 CFR 205.272). Organic 

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

by their accredited certifying agent (7 CFR 205.201). This plan enables the production operation to 

achieve and document compliance with the NOP, including the NOP prohibition on the use of 

excluded methods. Excluded methods include methods used to genetically modify organisms or 

otherwise influence their growth and development by means not possible under natural conditions or 

processes. 

Typically, there is more than one method for farms under organic practices to prevent unwanted 

pollen or seed from entering their fields including: isolation of the farm, physical barriers or buffer 

zones between organic production and non-organic production, as well as formal communications 

between neighboring farms (NCAT, 2003). The organic plan used as the basis for organic 

certification should include a description of practices used to prevent or reduce the likelihood of 

unwanted GE pollen or seed at each step in the farming operation, including planting, harvesting, 

storing and transporting the crop (NCAT, 2003). Organic plans should also include mechanisms to 

monitor the risk of GE pollen or seed co-mingling with the organic crop (Kuepper, 2002) . Farmers 

using organic methods are requested to let neighboring farmers know that they are using organic 

production practices and request that the neighbors also help the organic farmer reduce unwanted 

gene flow events (Krueger, 2007); (NCAT, 2003). Thus, commonly used production practices for 

corn, and the practical methods typically used by corn farmers using organic methods currently 

provide many measures that greatly reduce the likelihood of accidental gene flow between GE and 

non-GE corn fields. Efficacy of certified organic plans and practices to prevent the likelihood of 

unwanted substances is best represented by the parallel increases in both GE corn and organic corn 

production since 2000. These practices protect organic crops and thus maximize profits and price 

premiums accorded to corn under organic production. APHIS will assume that farmers are already 

using, or have the ability to use, these common practices as APHIS’ baseline for the analyses of the 

following alternatives below.

No Action Alternative

Current availability of seed for conventional (both GE and non-GE) corn varieties, and those corn 

varieties that are developed for organic production, are expected to remain the same under the No 

Action Alternative. Under the No Action Alternative, 5307 corn and its progeny would continue to 

be regulated articles under the regulations at 7 CFR part 340. This however, will not change the 

ready availability of other corn hybrid varieties produced through GE methods. GE corn will 
54

continue to represent a large majority of corn production acreage, with GE corn totaling 88 percent of 

all corn production in the U.S. in 2007 (USDA-ERS, 2010a). Trends of conventional and organic 

commercial corn production will not change and will remain the same under the No Action 

Alternative. Planting and production of GE corn varieties and organic corn have both increased due 

to market demands over the last ten years, and these markets are likely to continue to increase under 

the No Action Alternative.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the 

No Action Alternative. Transgenic corn lines including those that are insect resistant are already 

in use by farmers. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently 

available. Event 5307 corn should not present any new and different issues and impacts for 

organic corn producers and consumers. According to the petition, agronomic trials conducted in 

a variety of locations in the U.S. demonstrated that 5307 corn is not significantly different in 

plant growth, yield, and reproductive capacity from its nontransgenic counterpart. (Syngenta, 

2011c). No differences were observed in pollen diameter, weight, and viability. Therefore, 5307 

corn is expected to present no greater risk of cross-pollination than that of existing corn 

cultivars. The practices currently employed to preserve and maintain purity of organic 

production systems would not be required to change so as to accommodate the production of 

5307 corn. Because suppression of corn rootworm populations may occur in the vicinity of 5307 

production (analogous to the suppression of lepidopteran pests in other Bt expressing hybrids), 

organic crops should be favorably impacted by lessened rootworm populations and consequently 

less root damage than when 5307 hybrids are not grown. 

A determination of nonregulated status of 5307 corn is unlikely to significantly impact organic 

farmers that choose not to plant or sell corn products produced through genetic engineering or 

other non-organic production systems. Despite the wide-spread adoption of conventional and 

GE corn in the U.S. that amounted to 99.8 percent of total corn production in the U.S. in 2007,

organic corn production has also continued to expand in recent years (USDA-ERS, 2010a). 

This continued expansion of organic corn acreage, though minor relative to non-organic national 

and state corn production, reinforces the capacity of current organic system plans to avoid use of 

excluded methods (and thus, loss of NOP certification) and the efficacy of these plans to 

increasingly produce agricultural products to meet demand of target markets in spite of the 

overwhelming presence of non-organic farming systems. 

States that represented major organic corn production areas (> 10,000 acres) in the 2007 

Agricultural Census included Iowa, Michigan, Minnesota, New York, and Wisconsin (Table 7). 

Organic corn production in these states represented 0.16 to 1.25 percent of total corn production 

in each state. Despite the presence of millions of corn acres produced through excluded 

methods, no organic grower in this, or any other organic corn production region, has lost organic 

certification status. Thus, presently certified methods to maintain organic production as 

prescribed by the National Organic Program is effective in the maintenance of organic corn 

production. Accordingly, regions that are not anticipated to adopt 5307 corn, GE varieties 

currently represents the majority of cultivated corn, organic corn production would still 

represent a fraction of total corn production and prescribed NOP methods would be just as 

effective in preserving certified organic status.
55

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

Data were calculated from the 2007 Agricultural Census (USDA-NASS, 2009).

State Total Corn 

Production

(acres harvested)*

Percent 

Nonorganic

Organic Corn 

Production

(acres 

harvested)**

Percent 

Organic

Alabama 288,881 100 0 0

Alaska 1 100 0 0

Arizona 61,408 100 0 0

Arkansas 587,858 99.992 45 0.008

California 675,445 99.588 2,780 0.412

Colorado 1,172,893 99.893 1,257 0.107

Connecticut 32,347 99.975 8 0.025

Delaware 200,827 100 0 0.000

Florida 100,542 99.978 22 0.022

Georgia 510,709 99.991 48 0.009

Hawaii 3,641 99.918 3 0.082

Idaho 333,022 99.999 4 0.001

Illinois 13,214,365 99.947 7,031 0.053

Indiana 6,528,585 99.977 1,533 0.023

Iowa 14,075,332 99.841 22,330 0.159

Kansas 3,847,088 99.903 3,746 0.097

Kentucky 1,409,781 99.990 138 0.010

Louisiana 726,897 100 0 0

Maine 28,703 98.631 393 1.369

Maryland 533,903 99.733 1,427 0.267

Massachusetts 21,575 99.754 53 0.246

Michigan 2,658,538 99.465 14,231 0.535

Minnesota 8,352,731 99.726 22,864 0.274

Mississippi 888,049 100 0 0

Missouri 3,332,832 99.898 3,410 0.102

Montana 83,344 99.996 3 0.004

Nebraska 9,438,807 99.903 9,200 0.097

Nevada 6,006 100 0 0

New 

Hampshire 14,611 99.966 5 0.034

New Jersey 100,766 99.991 9 0.009

New Mexico 136,008 99.512 664 0.488

New York 1,099,413 98.754 13,703 1.246

North Carolina 1,028,533 99.933 689 0.067

North Dakota 2,528,921 99.953 1,189 0.047

Ohio 3,834,164 99.767 8,926 0.233

Oklahoma 301,443 99.999 3 0.001

Oregon 88,692 95.407 4,074 4.593

Pennsylvania 1,427,111 99.653 4,954 0.347
56

State Total Corn 

Production

(acres harvested)*

Percent 

Nonorganic

Organic Corn 

Production

(acres 

harvested)**

Percent 

Organic

Rhode Island 2,549 100 0 0

South Carolina 388,481 100 0 0

South Dakota 4,841,686 99.933 3,245 0.067

Tennessee 838,499 99.998 16 0.002

Texas 2,121,694 99.859 2,990 0.141

Utah 68,303 100 0 0.000

Vermont 93,876 98.714 1,207 1.286

Virginia 530,781 99.816 974 0.184

Washington 294,929 97.651 6,927 2.349

West Virginia 46,918 100 0 0

Wisconsin 4,074,833 99.247 30,673 0.753

Wyoming 86,740 99.618 331 0.382

Note: * and ** represent corn for grain, corn for silage, popcorn, and sweet corn. 

Source: Data were calculated from the 2007 Agricultural Census (USDA, 2009).

Other Specialty Corn Production Systems

As with the purity processes described above for seed production, specialty corn growers and end 

users maintain the identity of their products by contracts, tracking and traceability systems, quality 

assurance programs, closed loop systems, and identity preservation systems.

Specialty crop growers employ practices and standards for seed production, cultivation, and product 

handling and processing to ensure that their products are not pollinated by or commingled with 

conventional or GE crops (Bradford, 2006). These management practices include maintaining 

isolation distances to prevent pollen movement from other corn sources, planting border or barrier 

rows to intercept pollen, changing planting schedules to ensure flowering at different times, and 

employing natural barriers to pollen (Bradford, 2006); (NCAT, 2003); (Thomison, 2009); (Wozniak, 

2002). These management practices allow the grower to meet standards for the production of 

specialty crop seed, maintain genetic purity, and protect the genetic diversity of corn (Bradford, 

2006).

No Action Alternative

Other specialty corn production systems are not likely to change as a direct or indirect result of the 

No Action Alternative. Specialty products are likely to continue to be protected by the 

identity-preservation systems established in the industry even if 5307 corn continues to remain a 

regulated article. Regulated field trials of 5307 corn would only impact small plots of land with no 

effect on other specialty corn production systems.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 
57

Other specialty corn production systems are not likely to change as a direct or indirect result of the 

Preferred Alternative. Transgenic corn lines including those that are insect resistant are already in 

use by farmers. Event 5307 corn should not present any new and different issues and impacts for 

specialty corn producers and consumers. According to the petition, agronomic trials conducted in a 

variety of locations in the U.S. demonstrated that 5307 corn is not significantly different in plant 

growth, yield, and reproductive capacity from its nontransgenic counterpart (Syngenta, 2011c). No 

differences were observed in pollen diameter, weight, and viability. Therefore, 5307 corn is 

expected to present a no greater risk of cross-pollination than that of existing corn cultivars. The 

practices currently employed to preserve and maintain purity of specialty corn production systems 

would not be required to change so as to accommodate the production of 5307 corn.

4.2.4 Raw and Processed Corn Commodities

As described in Section 2.2.4, Raw and Processed Corn Commodities, there are no differences in 

handling requirements for processing transgenic and non-transgenic corn.

No Action Alternative

Raw and processed corn commodities are not likely to change as a direct or indirect result of the No 

Action Alternative. Raw and processed corn commodities would continue to be handled in 

accordance with regulatory standards and industry practices even if 5307 corn continues to remain a 

regulated article. Regulated field trials of 5307 corn would only impact small plots of land with no 

effect on raw or processed commodities.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Raw and processed corn commodities are not likely to change as a direct or indirect result of the 

Preferred Alternative. Based on Syngenta’s field trials, compositional profiles of grain and forage 

from 5307 corn hybrids are equivalent to those of the corresponding non-transgenic hybrids and 

commercial hybrids (Syngenta, 2011c). Apart from the expected insect control benefits and 

associated benefits in crop yield and crop health, 5307 corn hybrids are agronomically equivalent to 

their non-transgenic counterparts (Syngenta, 2011c). Similar to the no action alternative, grain 

channeling and stewardship plans preserving and documenting product purity would continue and 

would not change as a result of a determination of nonregulated status of 5307 corn. Raw and 

processed corn commodities would continue to be handled in accordance with regulatory standards 

and industry practices.

4.3 Physical Environment

This section describes the potential impacts to water quality and use, soil, air quality, and climate that 

may result from the No Action and Preferred Alternatives.

4.3.1 Water Quality and Use
58

Water Quality 

As described in Section 2.3.1, Water Quality, the primary cause of agricultural NPS pollution is 

increased sedimentation from soil erosion, which can introduce sediments, fertilizers, and pesticides 

to nearby lakes and streams. To a limited extent, some corn plant matter may be deposited in water 

courses adjacent to fields. Agronomic practices such as conservation tillage, crop nutrient 

management, pest management, and conservation buffers help protect water quality from agricultural 

runoff (Hoeft et al., 2000).

No Action Alternative

Water quality is not likely to change as a direct or indirect result of the No Action Alternative. Water 

quality would continue to be regulated by federal programs (some of which have been delegated to 

certain states) and agronomic practices to protect water quality would continue to be implemented 

even if 5307 corn remains a regulated article. Chemical insecticide use would likely continue to be 

reduced as transgenic corn products with insect resistance traits are developed, marketed, and 

adopted. Tillage practices would likely remain unchanged, so no increase in runoff into water sources 

would be observed. Crop nutrient management, pest management practices, and use of conservation 

buffers would likely be unchanged. Regulated field trials of 5307 corn would only impact small plots 

of land with no effect on water quality.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available.

Water quality is not likely to change as a direct or indirect result of the Preferred Alternative. Tillage 

practices would not likely change because of adoption of this crop, nor would other agricultural 

practices such as fertilizer application, pest management or provision of buffers if this crop were 

adopted. Similar to the no action alternative, water quality would continue to be regulated by federal 

programs (some of which have been delegated to certain states) and agronomic practices to protect 

water quality would continue to be implemented (such as a high percentage of acres under 

conservation tillage). 

Event 5307 corn does not contain any substances which have the potential to affect water quality and 

has no compositional differences from other commercial corn varieties, aside from the eCry3.1Ab 

protein. The eCry3.1Ab protein concentrations in 5307 corn are lowest at senescence, when grain is 

harvested, and any residual eCry3.1Ab protein is likely to degrade significantly during the period 

between harvest and transfer of any plant matter to the waterways (Syngenta, 2011c). In aquatic or 

terrestrial conditions any residual toxicity to target Lepidoptera of a related Bt expressed in corn does 

not persist for any longer than two weeks, and limited non target effects seem related to interactions 

between plant genetics and the environment, and not the Bt protein (Jensen et al., 2010). Water 

quantity in soil may have no effect on degradation, nor may pH, but increasing temperature increases 

degradation of Cry proteins (Feng et al., 2011).

Similar to the no action alternative, chemical insecticide use would continue to be reduced as 

transgenic corn products with insect-resistance traits are developed, marketed, and adopted, 

potentially improving water quality. Chemical herbicide use is not likely to change as a result of a 

determination of nonregulated status of 5307 corn.
59

Water Use

As described in Section 2.3.1, Water Use, the production of a bushel of corn requires some 

4,000 gallons of water, by either rainfall or supplemental irrigation. Section 2.2.2, Irrigation explains 

that transgenic corn products do not affect irrigation rates also required by other corn varieties.

No Action Alternative

Water use is not likely to change as a direct or indirect result of the No Action alternative. Even if 

5307 corn continues to remain a regulated article, irrigation rates would continue to be driven by local 

conditions (e.g., climate, water availability, water pumping capacity, and fuel and electrical costs). 

Regulated field trials of 5307 corn would only impact small plots of land with no effect on water use.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available.

Water use is not likely to change as a direct or indirect result of the Preferred Alternative. As 

described in Section 4.2.1.3, Irrigation, 5307 corn does not change corn’s water requirements. 

Similar to the no action alternative, irrigation rates would continue to be driven by local conditions.

 

4.3.2 Soil

As described in Section 2.3.2, Soil, agronomic practices such as crop type, tillage, and pest 

management regimes have greater effects on the biology of the soil than the type of corn cultivated. 

Degraded soil structure and composition may lead to decreased water retention, a decrease in soil 

carbon aggregation and net positive carbon sequestration, and increased greenhouse gas emissions. 

Conservation tillage methods can reduce these adverse effects (Holland, 2004) and full tillage by 

corn growers is declining ((Schimmelpfennig and Ebel, 2011) Table 8).

No Action Alternative

Soil characteristics are not likely to change as a direct or indirect result of the No Action Alternative. 

The adoption of insect-resistant corn varieties would be expected to continue. Corn growers would 

continue current agronomic practices and further declines in conventional tillage methods are

expected even if 5307 corn remains a regulated article (Schimmelpfennig and Ebel, 2011) Table 8). 

Regulated field trials of 5307 corn would only impact small plots of land with no effect on soil 

characteristics.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently 

available. Soil characteristics are not likely to change as a direct or indirect result of the Preferred 

Alternative. Event 5307 corn production would not change cultivation practices for transgenic or 

non-transgenic corn. Corn growers would continue current agronomic practices and would not 

change patterns of adoption of conservation tillage methods regardless of a determination of 

nonregulated status of 5307 corn. Event 5307 corn would not adversely impact soil composition. 

Most proteins do not persist or accumulate in soil because they are inherently degradable in soils 
60

that have normal microbial populations (Burns, 1982); (Marx et al., 2005). Cry proteins from B. 

thuringiensis are rapidly degraded in a variety of soil types and these proteins do not accumulate 

(Mendelsohn et al., 2003); (Dubelman et al., 2005); (Head et al., 2002). The eCry3.1Ab protein has 

been shown to have no biological activity after two weeks of incubation in “live” (with active 

microbes) loam soil (Syngenta, 2011c). For some Cry proteins residual amounts of Bt proteins 

may persist for extended periods (Feng et al., 2011), but at biologically insignificant quantities. 

4.3.3 Air Quality

As described in Section 2.3.3, Air Quality, agricultural activities such as burning, tilling, harvesting, 

spraying pesticides, and fertilizing, including the emissions from farm equipment, can directly affect air 

quality. Aerial application of insecticides may impact air quality from drift, diffusion, and volatilization 

of the chemicals, as well as motor vehicle emissions from airplanes or helicopters. 

No Action Alternative

With regard to transgenic corn with insect resistance traits, tilling, harvesting, and fertilizing practices do 

not vary between transgenic and non-transgenic agricultural varieties. Air quality impacts from aerial 

application of insecticides may vary between transgenic corn varieties with insect resistance traits and 

non-transgenic varieties because less insecticide application would be needed for transgenic varieties. Air 

quality is not likely to change as a direct or indirect result of the No Action Alternative. Corn 

growers would likely continue current trends in agricultural activities even if 5307 corn remains a 

regulated article. Regulated field trials of 5307 corn would only impact small plots of land with no 

effect on air quality.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently 

available. Similar to the no action alternative, indirect air quality benefits (Section 4.2.2, Insect 

Management,) may result from the use of insect resistant crops because of a reduction of aerial 

application of corn rootworm pesticides used in adult rootworm suppression. Spray application of 

insecticides could continue to be reduced if additional insect-resistant varieties are adopted by 

growers because 5307 corn would give growers another option to resist damage by corn rootworm.

However, because use of CRW resistant hybrids is not expected to greatly increase, air quality is 

not likely to change as a direct result of the Preferred Alternative. Corn growers would continue 

current trends in agricultural activities if 5307 corn is no longer subject to the regulatory 

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

4.3.4 Climate

U.S. agricultural crop production is identified as a major source of GHG emissions, second only to 

the U.S. energy sector. Crop production activities contribute directly to emissions of GHGs through a 

variety of processes, including the direct combustion of fossil fuels to support mechanized activities, 

abundance and frequency of agricultural chemical application (such as fertilizers) and other 

management practices, and the degradation of agricultural residues in the field or processing plant. 

Classes of crops planted are relevant to climate change, through crop dependent management 

practices and soil impacts. Additionally, geographic location and soil composition may also affect 

climate change through alterations in dynamic geophysical soil processes. Climate change itself may 
61

force changes to agricultural practices by altering agricultural weed and pest pressure (IPCC, 2007a). 

Indirect effects of new crops will be determined by the traits engineered into organisms and the 

management strategies used in the production of these organisms.

As described in Section 2.3.4, Climate, agriculture-related activities are recognized as both direct 

(e.g., exhaust from motorized equipment) and indirect (e.g., agriculture-related soil disturbance, 

fertilizer production) sources of greenhouse gases (GHGs). Transgenic crops in general have reduced 

the release of GHGs from agriculture, equivalent to removing 5 million cars from the roads each year 

(Brookes and Barfoot, 2005), although the portion attributable directly to insect-resistant corn 

products is not known.

The climate can also affect agricultural crop production, and climate change could affect corn yields 

either positively or negatively. 

No Action Alternative

Under the No Action Alternative, 5307 corn use would be limited to areas APHIS has approved for 

regulated releases. Agronomic management practices and phenotypic characteristics regarding 5307 

corn are similar to those of conventional corn; thus, differences of impacts between corn varieties 

would be minimal. Additionally, measurable effects from these confined field releases would be 

minor due to the small scale of management and acreage relative to current corn production systems 

in the U.S. There are no other characteristics of transgenic corn products with insect resistance traits 

and non-transgenic corn that would be expected to be different in response to climate change. 

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

A determination of nonregulated status of 5307 corn is unlikely to significantly affect current corn 

management practices. Management decisions regarding agricultural effects of climate change, 

including tillage, agricultural chemical application, and rotational strategies are not anticipated to 

differ between 5307 corn and conventional corn. In particular, due to the continued availability of 

herbicide choice in 5307 corn management, no-till or reduced till practices will likely continue to 

mitigate soil erosion, stabilizing soil quality attributes and reducing GHG emissions.

Agronomic performance and phenotypic characteristics of 5307 corn is not significantly

different from conventional corn, with the exception of a different Cry protein to deter CRW 

infestation. Accordingly, the physical impact of 5307 corn on climate change is not anticipated to be 

significantly different from that of conventional corn. Intensive management will continue to be 

practiced on a scale similar to current levels of U.S. corn production, because of the phenotypic 

equivalence of 5307 corn and conventional corn.

4.4 Biological Environment

This section describes the potential impacts to animals, plants, biodiversity, and gene movement in 

the natural environment, that may result from the No Action and Preferred Alternatives.
62

4.4.1 Animals

As described in Section 2.4.1, Animals, corn fields may be temporarily or permanently occupied by 

invertebrates, birds, reptiles and amphibians, and mammals. Aquatic organisms may reside in water 

bodies adjacent to corn fields. Animals can have positive, negative, or no effect on corn production.

Insect-resistant corn varieties are targeted to certain invertebrate species that negatively impact corn. 

Table 2-1, Transgenic Corn Cultivars Containing Bt-derived Proteins with Nonregulated Status, 

lists the transgenic corn cultivars containing Cry or Vip proteins for insect resistance that are no 

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

Plant Protection Act. These cultivars are Lepidopteran (European corn borer and other species) or 

Coleopteran (corn rootworm) resistant.

No Action Alternative

The following paragraphs summarize potential exposure pathways and available information on the 

effects of Cry proteins on non-target invertebrates, aquatic organisms, birds, and mammals.4

Conventional broad-spectrum insecticides are potentially toxic to invertebrates and vertebrates 

(including humans) as discussed in Section 2.2.2.3, Insect Management. The US-EPA requires 

application control measures for certain Restricted Use insecticides, including several used for corn 

rootworm control, to limit human and environmental exposure. Bt foliar sprays contain Cry proteins 

and are approved insecticides for use in organic production systems to control moths, beetles, 

mosquitoes, and flies (Lepidoptera, Coleoptera, and Diptera), and exhibit low toxicity to non-target 

organisms.

Non-Target Invertebrates. Transgenic Bt crops, including corn, containing Cry proteins could 

potentially affect non-target invertebrates that directly consume Bt plant material or are exposed via 

Cry protein residues in soil, water, or prey species. However, for a Cry protein to exert toxicity, the 

appropriate activating enzyme(s) and receptor binding sites would need to exist in the midgut of the 

non-target species, and sufficiently high concentrations of active Cry protein would have to reach 

these binding sites.

Non-target invertebrates as well as certain arthropods may feed or reside on corn plants: species that 

feed extensively on corn plants may be pests. The more likely route of exposure to transgenic 

proteins is consumption of prey that have fed on transgenic corn plants or consumption of transgenic 

pollen if prey is scarce (Harwood et al., 2005). The concentration of Cry proteins in the prey of nontarget arthropods will vary depending on the prey species, its developmental stage, and the 

concentration of Cry protein in plant parts on which they are feeding. Several studies have examined 

the concentration of a representative Cry protein (Cry1Ab) in herbivores relative to the concentration 

in plants on which they are feeding. In general, the results show that herbivorous arthropods contain 

lower concentrations of Bt toxin than the plants on which they are feeding:

• Sucking insects, such as aphids, contain only trace amounts of Cry1Ab when feeding on 

Bt corn (Head et al., 2002); (Raps et al., 2001); (Dutton et al., 2002); (Obrist et al., 2006);

• Lepidopteran larvae contain between 0.1 and 0.25 times the concentration of Cry1Ab in 

Bt corn on which they are feeding (Dutton et al., 2002); (Obrist et al., 2006b);

 4 Potential impacts to threatened and endangered species are separately discussed in Section 4.4.5.
63

• Thrips (Frankliniella tenuicornis) contain up to 0.35 times the concentration of Cry1Ab in 

Bt corn, although adults contain about half this amount and pupae less than 1/40th the 

concentration in larvae (Obrist et al., 2005); and

• Spider mites (Tetranychus urticae) have been found to contain between 0.7 and approximately 

4.6 times the concentration of Cry1Ab in Bt corn (Dutton et al., 2002); (Obrist et al., 2006a); 

(Obrist et al., 2006b); (Álvarez-Alfageme et al., 2008)

Multiple indicator species have been exposed to purified Bt proteins in direct feeding studies; these 

studies have typically not shown any hazard to the tested species, despite exposure to very high test 

concentrations under “no choice” conditions where the species was continually exposed through its 

diet. Some laboratory studies have found an effect, but concluded through refinement of exposure 

models and estimates, or via field studies, that the effect was not adverse or not representative of field 

conditions (Duan et al., 2010).

Corn rootworm predators could ingest Cry proteins when consuming corn rootworms that have 

consumed Bt corn plant material. A study of a transgenic corn product expressing the Cry3Bb1 

protein found no significant effects on predators for any measured parameter (including larval 

development, physical characteristics, and mortality) (Ahmad et al., 2006 ).

Honey bees could potentially forage for corn pollen and therefore could be exposed to Cry proteins

(Severson (Severson and Parry, 1981). Honey bees can successfully rear young on a diet of 

100 percent corn pollen; however, it is unlikely that corn pollen regularly comprises more than 

50 percent of their diet (Babendreier et al., 2004). Laboratory studies indicate that Cry proteins have 

no adverse effects on honey bees (Duan et al., 2008).

A meta-analysis of 74 laboratory studies of Cry protein toxicity and 52 field studies of Bt crops 

containing the same Cry proteins revealed that laboratory studies correctly predicted the reduced field 

abundance of certain non-target Lepidoptera exposed to lepidopteran-active proteins (Duan et al., 

2010) . In the case of predators consuming prey that had fed on lepidopteran-active Bt plants, some 

laboratory tri-trophic studies identified reduced abundances that were, nevertheless, not observed 

under field conditions; thus, the laboratory studies overestimated risk. However, laboratory studies 

incorporating tri-trophic interactions of lepidopteran-active Bt plants, herbivores, and parasitoids 

were better correlated with the decreased field abundance of parasitoids than were direct-exposure 

assays. This result is not surprising because many parasitoids are associated specifically with target 

pests of Bt crops. Control of pest species by Bt crops can be expected to indirectly affect the 

abundance of their specialist parasitoids under field conditions. In similar studies with Coleopteranactive Cry proteins and Bt plants, the meta-analysis revealed no adverse effects on survival in 

laboratory studies or field abundance for any functional group of non-target arthropods examined, 

including Coleopteran and non-Coleopteran species.

Transgenic insect-resistant products may reduce broad-spectrum insecticide use, as described in 

Section 4.2.1.4, Insect Management. Since the commercialization of Bt crops, there have been a 

substantial number of field studies that have demonstrated that non-target invertebrates are generally 

more abundant in Bt cotton and Bt corn fields than in non-transgenic fields managed with chemical 

insecticides (US-EPA, 2007a). These studies demonstrate that, not only are the Bt crops not causing 

any unreasonable adverse effects in the environment, but arthropod prevalence and diversity is 

greater in Bt crop fields.
64

Aquatic Non-Vertebrate Organisms A potential route of exposure of aquatic organisms to 

insecticidal proteins from Bt corn is through pollen deposited into water bodies adjacent to corn 

fields. As explained in Section 4.3.1, Water Quality, corn pollen is heavy and wind-borne pollen 

densities decrease rapidly from the source. Any pollen deposited into water bodies from adjacent 

fields during the corn anthesis period (up to 14 days) is unlikely to remain in suspension. In addition, 

the bioactivity of transgenic proteins is likely to degrade in pollen grains deposited in water (Prihoda, 

2008).

Unharvested corn material deposited in water bodies as litter could also potentially introduce Cry 

proteins to aquatic organisms. However, significant degradation of protein is likely to occur during 

the period between harvest and transfer to the waterways (Syngenta, 2011c) and between when the 

material is deposited in waterways and when it becomes palatable to aquatic organisms.

Fish. Commercially raised fish may be exposed to corn grain containing Cry proteins. About 

30 percent corn grain by weight is typical in commercial fish feeds used in aquaculture (NRC, 1983). 

Fish feed is heat-treated during preparation and it is likely that Cry proteins in feed prepared from 

insect-resistant corn would be at least partially denatured by heat and lose activity. Corn in fish feed 

is unlikely to comprise 100 percent insect-resistant corn grain (USDA-NASS, 2011a). The mode of 

action of most Cry proteins is highly specific to insects and is not biologically active in vertebrate 

species, including fish (Syngenta, 2011c).

Birds The principal potential route of exposure of birds to Cry proteins is through ingestion of 

kernels. Some birds such as crows (Corvus brachyrhynchos), grackles (Quiscalus quiscula), and 

sandhill cranes (Grus canadensis) uproot sprouting corn to feed on the germinating kernels (Steffey 

et al., 1999); (Blackwell et al., 2001); (Sterner et al., 2003). Red-winged blackbirds typically slit open 

husks with their bills and puncture kernels in the milk stage (Steffey et al., 1999). Blackbirds also 

forage for spilled kernels and weed seeds in corn stubble (Linz et al., 2003). Wild birds are unlikely 

to consume a diet of 100 percent corn kernels. The diets of red-winged blackbirds and common 

grackles, for example, are comprised of up to 50 percent corn kernels (McNichol et al., 1979); 

Homan et al, 1994 (Homan et al., 1994). The mode of action of most Cry proteins is highly specific 

to insects and these proteins are not biologically active in vertebrate species, including birds

Syngenta, 2011c (Syngenta, 2011c). Cry proteins are therefore are not expected to adversely affect 

non-target vertebrates (Shimada et al., 2006).

Mammals The principal potential route of exposure of wild mammals to Cry proteins from Bt corn is 

through ingestion of corn kernels. Rodents such as thirteen-lined ground squirrels, deer mice, house 

mice, prairie and meadow voles (Microtus spp.), and woodchucks feed on germinating corn seeds

(Syngenta, 2011c). Larger mammals such as white-tailed deer typically nip off ear tips and raccoons 

chew through husks. Wild mammals are unlikely to consume a diet of 100 percent corn kernels. For 

example, the proportion of corn kernels in wild rodent diets varies greatly according to species, but 

can be up to 73 percent (Syngenta, 2011c). The mode of action of most Cry proteins is highly 

specific to insects and these proteins are not biologically active in vertebrate species, including 

mammals (Syngenta, 2011c). Cry proteins are therefore are not expected to adversely affect nontarget vertebrates (Shimada et al., 2006).

Overall Conclusion

Non-target species of animals would not be affected as a direct or indirect result of the No Action 

alternative. Animal exposure to genetically modified crops containing Cry proteins would be nearly 
65

identical to current conditions even if 5307 corn continues to remain a regulated article. Approved 

genetically modified crops containing Cry proteins would continue to be used by growers and there 

would be no change in animal exposure rates outside of controlled environments. Pesticide usage 

would continue to have the same effects on animal species. Chemical insecticides would continue to 

be applied, following current trends in application rates, and organic corn growers would continue to 

apply microbial Bt foliar sprays. Regulated field trials of 5307 corn would only impact small plots of 

land with controlled animal incursions.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Non-target species of animals are not likely to be affected as a direct or indirect result of the 

Preferred Alternative. Under the preferred alternative, animal exposure to genetically modified crops 

containing Cry proteins would be similar to current conditions. 

Event 5307 corn has been demonstrated not to adversely impact non-target species. Syngenta fed 

various nontarget organisms with the eCry3.1Ab protein to establish a no observable adverse effect 

concentration (NOAEC) or level (NOAEL). This value was then compared to the Environmental 

Exposure Concentration (EEC) and Daily Dietary Dose (DDD) values to make judgments about risk. 

The effects studies identified any potential for eCry3.1Ab proteins to cause adverse effects in 

representative nontarget organism species representing a corn ecosystem. In each study, a 

representative species was exposed to a high concentration or dose of eCry3.1Ab. No harmful effect 

of such exposure on survival was observed in any species tested, and the concentration of eCry3.1Ab 

in each study can be interpreted as the minimum value of the NOAEC for the mortality endpoint. 

Computing a ratio of the NOAEC to the EEC or DDD results in the toxicity exposure ratio (TER). 

This ratio is also known as the ‘margin of exposure’ or ‘margin of safety.’ A TER ≥ 1.0 provides a 

degree of confidence that the absence of adverse effects in these hazard studies with indicator species 

is predictive of the safety of eCry3.1Ab in cultivation of 5307 corn for nontarget organisms in 

general. The larger the TER, the higher the degree of confidence in the safety judgment and the 

lower the risk. Table 4-2 contains the NOAEC and corresponding TER values for each indicator test 

species (Syngenta, 2011c).

 

Table 8: Nontarget organism TER values for eCry3.1Ab.

TER values are computed as the ratio of NOAEC: EEC (or NOAEC: DDD) and are based on estimates of 

exposure to eCry3.1Ab via cultivation of 5307 corn.

Test Species NOAEC/NOAEL EEC or DDD TER

Bobwhite quail 900mg/kg bw 0.80 mg/kg bw 1100

Mouse 2000 mg/kg bw 1.10 mg/kg bw 1800

Honeybee 50 μg/g diet 0.07 μg/g diet 710

Spotted ladybird beetle 353 μg /g diet 5.07 μg/g diet 70

Flower bug 400 μg/g diet 5.07 μg/g diet 79

Carabid beetle 400 ug/g diet1 0’34 ug/g diet 1200 (mortality)

1200 (weight)
66

Rove beetle 400 μg/g diet 0.34 μg/g diet 1200

Earthworm 4.06 μg/g soil 0.34 μg/g diet 12

Freshwater shrimp 100% 5307 corn < 100% 5307 corn > 1

Farmed fish 41% 5307 corn grain 9.5% 5307 corn grain 4.3

1 This NOAEC is based on the mortality endpoint for this species; a 20% reduction in weight was observed

Bt and Activity Spectrum of Cry protein. Syngenta’s plant tissue studies determined that, on a freshweight basis, the concentrations of eCry3.1Ab in individual samples across all locations and plant 

stages ranged from less than the lower limit of quantification (< LOQ)5 to 71.21 micrograms per 

gram (μg/g) in leaves, 0.40 μg/g to 9.29 μg/g in roots, 1.60 μg/g to 7.29 μg/g in kernels, < LOQ6 to 

0.09 μg/g in pollen and 1.70 μg/g to 28.64 μg/g in whole plants (Syngenta, 2011c). Activity spectrum 

data indicate that the insecticidal effects of eCry3.1Ab are limited to certain species of the 

Chrysomelidae family of Coleoptera. The eCry3.1Ab protein demonstrates no Lepidopteran activity, 

despite containing sequences from a Lepidopteran-active protein (Syngenta, 2011c). demonstrating

the specificity of the eCry3.1Ab protein. There would be no additional risk to animals from 

widespread cultivation of 5307 corn.

Well-characterized modes of action, physicochemical properties, and results of safety studies (as 

summarized below) demonstrate that the eCry3.1Ab protein present in 5307 corn presents no 

evidence of risk of harm for avian, fish, or mammalian species. Laboratory testing has similarly 

shown no adverse effects on survival associated with exposures of eCry3.1Ab in a range of 

non-target invertebrate species (Syngenta, 2011c).

Non-Target Invertebrates. Syngenta has conducted laboratory tests on six species representing nontarget invertebrates potentially exposed to eCry3.1Ab via cultivation of 5307 corn. In summary, there 

were no statistically significant differences in survival between treatment and control groups of:

1. Honey bees (Apis mellifera) Syngenta, 2011c (Syngenta, 2011c),

2. Spotted ladybird beetle larvae (Coleomegilla maculata) (Syngenta, 2011c),

3. Second-instar flower bugs (Orius laevigatus) (Syngenta, 2011c),

4. Larvae of Poecilus cupreus, a carabid beetle (Syngenta, 2011c),

5. Adult rove beetles (Aleochara bilineata) (Syngenta, 2011c), or

6. Adult earthworms (Eisenia fetida) (Syngenta, 2011c).

Aquatic Non-Vertebrate Organisms. Syngenta has conducted laboratory tests on two species 

representing aquatic organisms potentially exposed to eCry3.1Ab via cultivation of 5307 corn. 

Aquatic concentrations of eCry3.1Ab are expected to be far below those at which biological activity 

is observed among known eCry3.1Ab-sensitive species. In summary, there were no statistically 

significant differences between treatment and control groups of adult gammarid freshwater shrimp 

(Gammarus fasciatus) (Syngenta, 2011c).

 5 LOQ for leaves was 0.02 [μg/g] (Syngenta, 2011; pg. 88). 6 LOQ for pollen was 0.08 μg/g (Syngenta, 2011; pg. 88).
67

Possible exposure of nontarget aquatic invertebrate organisms to other Bt toxins has been considered, 

and the most recent has been an analysis of possible environmental effects of Cry1Ab contained 

within decomposing plant tissues (Jensen et al., 2010). Studied by comparing Bt expressing corn 

with near isolines, no consistent pattern of environmental impact of either the Bt expressing corn or 

its isoline on nontarget aquatic shredders was detected (Jensen et al., 2010).

Fish. There were no statistically significant differences between treatment and control groups of 

juvenile channel catfish (Ictalurus punctatus) (Syngenta, 2011c). 

Birds. Syngenta has conducted laboratory tests on two species representing birds potentially exposed 

to eCry3.1Ab via cultivation of 5307 corn. In summary, there were no statistically significant 

differences in survival or overall performance between treatment and control groups of juvenile 

bobwhite quail (Colinus virginianus) (Syngenta, 2011c) or broiler chickens (Gallus gallus 

domesticus) (Syngenta, 2011c)

Mammals. Syngenta has conducted laboratory tests on one species representing mammals potentially 

exposed to eCry3.1Ab via cultivation of 5307 corn. There were no statistically significant differences 

between treatment and control groups of mice (Mus musculus) (Syngenta, 2011c).

Overall Conclusions. Syngenta initiated a voluntary pre-market consultation process with FDA and 

submitted a Safety and Nutritional Assessment (Appendix B, (Syngenta, 2011a). The assessment 

demonstrated that the introduced proteins, eCry3.1Ab7 and phosphomannose isomerase (PMI),8 in 

5307 corn are not toxic to human and animal consumers and have minimal allergenic potential. 

Additionally, Syngenta’s assessment showed that 5307 corn is nutritionally equivalent to nontransgenic corn and other corn in commerce.

A determination of nonregulated status of 5307 corn would not substantively change the overall 

usage of transgenic corn products with insect resistance traits. Similar to the no action alternative, 

other approved genetically modified crops containing Cry proteins have been demonstrated to have 

no adverse effects on animals and would continue to be used by growers. Pesticide usage would 

continue to have the same effects on animal species. Similar to the no action alternative, chemical 

insecticides would continue to be applied, following current trends in application rates, and organic 

corn growers would continue to apply microbial Bt foliar sprays. Adoption of 5307 corn may reduce 

the use of broad-spectrum insecticides, with a consequent reduction of potential impacts on the 

diversity of non-target insects (Dively, 2005); (Marvier et al., 2007). Additionally, because it 

represents a new tool for corn rootworm control, the use of 5307 corn could help reduce the 

likelihood that rootworm resistance to chemical pesticides would increase (Syngenta, 2011c) because 

growers will have an effective new resistance trait, and one whose efficacy can be enhanced by 

pyramiding with other CRW resistance traits. This could help avoid future increases in the use rates 

of chemical insecticides that might otherwise result if current use rates became less effective in 

controlling rootworms.

Event 5307 corn is not substantively different in its effects on non-target species from other approved 

insect-resistant corn products with Cry proteins. The eCry3.1Ab protein present in 5307 corn has a 

unique binding site in the target pest but acts by the same general mechanism (i.e., pore formation in 

 7 US-EPA has issued a temporary tolerance exemption for eCry3.1Ab in corn (Federal Register 76:180; Pgs. 57653-57657; US-EPA. 2011a) and 

Syngenta has petitioned for a non-expiring tolerance exemption. 8 US-EPA has granted a permanent tolerance exemption for PMI in all crops (40 CFR Part 180.1252; US-EPA. 2007b).
68

the target pest gut) as the approved Cry protein products that are currently available for use by 

growers. As described in Section 2.2.2, Insect Management, some species of corn rootworm have 

developed resistance to certain chemical pesticides. Similarly, insects may develop resistance to the 

insecticidal proteins in transgenic Bt crops. US-EPA has required refuges of non-transgenic corn

alongside plantings of CRW resistant hybrids, which should minimize the potential for insects to 

develop resistance. Extension entomologists further suggest planting pyramided CRW resistance 

traits to provide multiple modes of action against the target insects, as well as incorporating 

additional strategies (Gray, 2011c). These issues are more fully discussed in the cumulative impacts 

section.

4.4.2 Plants

As described in Section 2.4.2, Plants, corn fields can be bordered by other agricultural fields 

(including other corn varieties), woodlands, or pasture and grasslands. The most agronomically 

important members of a surrounding plant community are those that behave as weeds. Section 2.2.2,

Weed Management, explains the range of methods that growers use for weed control, including 

integrated weed management. These methods may be cultural (planting), mechanical (tillage), and 

chemical (herbicide), or some combination thereof. As described in Section 2.1.1, Persistence in the 

Environment/Weediness Potential, cultivated corn is not a weed and transgenic cultivars currently on 

the market have not changed corn’s weediness potential.

No Action Alternative

Plants would not be affected as a direct or indirect result of the No Action Alternative. Under the No 

Action Alternative, weed management methods would continue following current trends and 

practices. Regulated field trials of 5307 corn would only impact small plots of land with controlled 

plant exposures. No impacts to plant species compared to any effects from current agronomic 

practices are anticipated.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Plants would not be affected as a direct or indirect result of the Preferred Alternative. Event 5307 

corn expresses no herbicidal traits. Event 5307 corn production would not change land acreage or 

cultivation or cropping practices for transgenic or non-transgenic corn. Event 5307 corn does not 

have increased persistence in the environment or weediness potential compared with non-transgenic 

corn (Syngenta, 2011c). No changes in impacts to non-weed plant species compared to any effects 

from current agronomic practices are anticipated. 

4.4.3 Soil Microorganisms

Soil bacterial communities are influenced by plant species and cultivars as well as other 

environmental factors, such as soil type and agricultural practices (Icoz et al., 2008). Microorganisms

that colonize the rhizosphere are affected by plant type and root exudates influence the (Icoz et al., 

2008) et al, 2008). While B. thuringiensis occurs naturally in soil, growing transgenic Bt corn increases 

the amount of Cry endotoxins present in agroecosystems (Blackwood and Buyer, 2004). As noted in 

Section 4.3.2, Soil, most proteins do not persist or accumulate in soil because they are inherently 

degradable in soils that have normal microbial populations (Burns, 1982). 
69

The numbers of microorganisms and the activity of some enzymes involved in the degradation of 

plant biomass differ significantly by season, probably as a result of differences in the water content of 

soils, ambient temperatures, and plant stage growth at the time of sampling (Icoz et al., 2008). Cry 

protein concentrations in the rhizosphere vary during the growth of the plant and can be affected by 

microbial activity, which depends in part on soil temperature and humidity (Baumgarte and Tebbe, 

2005). 

No Action Alternative

Soil microorganisms would not be affected as a direct or indirect result of the No Action alternative. 

The use of transgenic corn producing Cry proteins and the use of other Bt-derived insecticides would 

continue following current trends. Regulated field trials of 5307 corn would only impact small plots 

of land with controlled plant exposures. 

Cry proteins are typically expressed in all or most tissues throughout the plant’s life cycle, potentially 

creating routes of exposure for soil organisms through root exudation, trophic level interactions, plant 

decomposition after harvest, and toxin persistence in the soil (Devare et al., 2004). However, 

different effects of Bt plants on microbial communities in soil, ranging from no effects to minor and 

statistically significant effects, have been reported (Icoz et al., 2008). One study concluded that plant 

variety (but not the presence of Cry proteins) had a significant but transient effect on the numbers of 

microorganisms and the activities of enzymes involved in the degradation of plant biomass (Icoz et 

al., 2008), while another study found no deleterious effect of growing corn-rootworm-resistant Bt 

corn on microbial biomass, activity, or bacterial community structure (Devare et al., 2004). 

Cry proteins derived from Bt are rapidly degraded in a variety of soil types and the proteins typically 

do not accumulate in soil (Mendelsohn et al., 2003); (Head et al., 2002); (Dubelman et al., 2005). Soil 

type has a large effect on the microbial community and availability of Cry proteins (Blackwood and 

Buyer, 2004). Certain Cry proteins may adsorb rapidly to clay minerals, on the clay-sized fraction of 

soil, on humic soils, and on complexes of montmorillonite-humic acids aluminum hydroxypolymers 

(Saxena and Stotzky, 2001). Some field studies on the persistence of Cry proteins released by 

transgenic plants showed that Cry proteins do not persist and degrade rapidly in soil, although a small 

fraction may be protected from biodegradation in the plant matrix or bound on surface-active 

particles (Icoz et al., 2008). No impacts to soil microorganisms compared to any effects from current 

agronomic practices are anticipated.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Soil microorganisms would not be affected as a direct or indirect result of the Preferred Alternative. 

Syngenta conducted a laboratory study to examine the fate of eCry3.1Ab in live soil. A rapid decline 

in eCry3.1Ab bioactivity was observed: no biological activity above background control levels was 

detected after 14 days of eCry3.1Ab incubation in live soil (Syngenta, 2011c). The Cry protein 

present in 5307 corn does not bioaccumulate and a laboratory study demonstrated that eCry3.1Ab 

biological activity is rapidly degraded in healthy soils. If growers are not using corn traits with insect 

resistance, they may instead treat for rootworm with insecticides. A comparison of a corn rootworm 

resistant Bt corn variety and a non-transgenic control corn treated with a conventional insecticide 
70

concluded that the addition of the conventional insecticide had greater effects on the microbial 

function in soil and decaying roots than did Bt corn (Lawhorn et al., 2009).

The US-EPA has concluded that Bt crops have a positive effect on soil flora compared to nonselective synthetic chemical pesticides (US-EPA, 2001); IIC53). Even though Bt is ubiquitous in 

soils, the presence and release of Bt toxins from the aboveground and belowground parts of Btexpressing plants may influence microbial diversity. Bt toxins have been found to be present in most 

tissues of Bt plants (Sivasupramaniam et al., 2008). However, studies have found no differences in 

microbial biodiversity or activity between fields cultivated with Bt corn or the corresponding non-Bt 

corn (Icoz et al., 2008).

Other Cry proteins released in root exudates of Bt corn or from the degradation of biomass of Bt 

corn are not toxic to earthworms, nematodes, protozoa, bacteria, or fungi (Saxena and Stotzky

(Saxena and Stotzky, 2001). The US-EPA has determined that Cry proteins do not have any 

measurable adverse effect on microbial populations in the soil and that horizontal transfer of genes 

from transgenic plants to soil bacteria has not been demonstrated (US-EPA, 2001) section IIC). No 

changes in impacts to soil microorganisms compared to any effects from current agronomic 

practices are anticipated.

4.4.4 Biodiversity

Biodiversity in an agroecosystem depends on the diversity of vegetation within and around the 

agroecosystem; permanence of crops within the agroecosystem; intensity of management; and the 

extent of isolation from natural vegetation (Altieri, 1999). Determining the level of biological 

diversity associated within any crop agroecosystem is complex because biological diversity can be 

defined and measured in many ways. Another difficulty with biodiversity studies is separating 

expected impacts from indirect impacts. For example, reductions of biological control organisms are 

seen in some Bt-expressing transgenic crops but are caused by reduction of the pest host population 

rather than as a direct effect (USDA-APHIS, 2011a).

Many studies over the last 10 years have investigated the differences in biological diversity and 

abundance between transgenic and non-transgenic crop fields, particularly those transgenic crops 

that are resistant to insects (e.g., Bt crops) or herbicides (e.g., glyphosate- or glufosinate-tolerant). 

Conflicting results are often reported. Some studies have found negligible to modest decreases in 

biological diversity or abundance attributed to crops genetically engineered to produce insecticidal 

proteins or tolerate herbicide application for weed management (Marshall et al, 2003; pg 85; 

(Pilcher et al., 2005); (Ponsard et al., 2002). Other studies compared Bt crops to non-transgenic 

crops that were unsprayed or sprayed with insecticides and found that Bt crops do not cause any 

overall changes in arthropod abundance or diversity (Chen et al., 2008); (Romeis et al., 2006); 

(Torres and Ruberson, 2005); (Wolfenbarger et al., 2008). A review of over 360 research papers 

concluded that there is no evidence of landscape-level effects from Bt crops (Carpenter, 2011). 

Compared to the use of broad-spectrum insecticides in agriculture, Bt crops may increase 

biological diversity in agroecosystems by reducing broad-spectrum insecticide use, thus allowing 

more non-target species to survive (Marvier et al., 2007); (Romeis et al., 2006). Transgenic crops 

may generally increase the productivity of cultivated lands, so biodiversity is protected because 

additional land is not needed for the same volume of crop production (Raven, 2010).

No Action Alternative
71

Biodiversity would not be affected as a direct or indirect result of the No Action Alternative. 

Biodiversity within agroecosystems would continue to be affected by agricultural practices following 

current trends. Growers would continue to have access to existing nonregulated insect-resistant corn 

varieties, and adoption of new transgenic corn varieties would be expected to continue even if 

5307 corn continues to remain a regulated article. Regulated field trials of 5307 corn would only 

impact small plots of land with controlled animal and plant incursions. No changes in biodiversity 

compared to effects from current agronomic practices are anticipated.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Similar to the use of other insect resistant crops, biodiversity would be improved as a direct result of 

the Preferred Alternative as chemical pesticide use rates would likely decrease because of the 

introduction of this insect-resistant cultivar. Event 5307 corn production would not change land 

acreage or cultivation practices for transgenic or non-transgenic corn. Event 5307 corn incorporates 

a Cry protein with a similar receptor-specific mode of action as other Cry proteins present in 

approved insect-resistant corn cultivars and does not have increased persistence in the environment or 

weediness potential over non-transgenic corn (Syngenta, 2011c). As described in Section 4.2, Corn 

Production, 5307 corn does not exhibit any different agronomic traits, apart from resistance to corn 

rootworms, or require different agronomic practices. As described in Section 4.4.1, Animals, and 

Section 4.4.2, Plants, animal and plant species that typically inhabit corn production areas would be 

managed the same as other for other insect-resistant corn products currently available to growers. 

4.4.5 Gene Movement in the Natural Environment

Corn is a highly domesticated plant with limited gene movement in the natural environment, and 

gene movement from transgenic corn is not any different than that of other cultivated corn varieties

(USDA-APHIS, 2011a). As described in Section 2.2.5, Persistence in the Environment/Weediness 

Potential, corn is dependent upon humans for survival. Cultivated corn has limited sexual 

compatibility with its closest relative, teosinte, but no wild populations of teosinte exist in the US 

outside of some feral populations in Alabama, Florida, and Maryland (USDA-NRCS, 2011a).

No Action Alternative

Corn’s characteristic of limited gene movement in the natural environment would not be affected as a 

direct or indirect result of the No Action alternative. Corn breeding by traditional or transgenic means 

would continue even if 5307 corn continues to remain a regulated article. Regulated field trials of 

5307 corn would only impact small plots of land with minimal potential for exposure to sexually 

compatible plants (i.e., other corn plants). No changes in gene movement characteristics of current 

corn varieties are anticipated.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Corn’s characteristic of limited gene movement in the natural environment would not be affected as a 

direct or indirect result of the Preferred Alternative. Corn can only be crossed experimentally with the 
72

genus Tripsacum, and does not persist outside of cultivation. The only known propagation method 

for corn is through seed germination. Like many domesticated crops, corn seed from a previous 

year’s crop can overwinter and germinate the following year. Corn seedlings may appear in soybean 

fields following a corn crop in a corn on soybean rotation. These plants do not result in sustained 

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

successful weeds. Event 5307 corn has no more potential for gene introgression to sexually 

compatible wild relatives than other transgenic or non-transgenic corn varieties since characteristics 

such as pollen longevity and others were not different from comparator corn varieties (Syngenta, 

2011c). 

An extensive review of information relevant to the potential risks of horizontal gene transfer for Bt 

crops to soil microbes was conducted by the US-EPA. No evidence of horizontal gene transfer under 

field conditions was found, and there was only equivocal evidence for horizontal gene transfer under 

laboratory conditions designed to maximize the recovery of transformants (US-EPA, 2001); section

IIC16).The codons in the ecry3.1Ab gene are optimized for expression in plants, and hence the gene 

is likely to have low sequence homology with genes of soil microbes (Syngenta, 2011c).

Consequently, horizontal gene transfer of ecry3.1Ab from 5307 corn to soil microbes is highly 

unlikely and the probability of spread of ecry3.1Ab outside corn cultivation by horizontal gene 

transfer is also negligible (Eede et al., 2004). No changes in gene movement characteristics compared 

to current corn varieties are anticipated.

4.5 Public Health 

This section describes the potential impacts to human health, animal (livestock) health, and worker 

safety that may result from the No Action and Preferred Alternatives.

4.5.1 Human Health

The general public is often concerned about the potential impacts that transgenic products could have 

on human health because of possible toxic or nutritional effects of the products, or how the product 

might change the allergenicity of food products. Insecticidal Cry proteins from B. thuringiensis have 

a long history of safe use in food crops (US-EPA, 2001)(updated 2011). Their modes of action are 

highly specific within narrow ranges of related insect species, and are not relevant to mammals or 

other vertebrates. PMI, the selectable marker protein produced by 5307 corn plants, is exempt from 

food and feed tolerances (US-EPA, 2004).

The US-EPA requires seed registrants to submit tests of potential toxicity and allergenicity of the 

transgenic proteins in Bt corn cultivars before they can be approved for human consumption. All tests 

that have been performed for adverse mammalian impact from ingesting Cry proteins have been 

negative, even at extremely high doses (Wu, 2006a). The toxicity of insecticidal Bt proteins depends 

on binding to specific receptors present in the insect midgut. With regard to the specific Cry proteins 

produced in Bt crops, research demonstrates that this specificity limits each protein’s toxic effect to 

certain insect species.

As described in Section 1.1, Regulatory Authority, it is the responsibility of food and feed 

manufacturers to ensure that the products they market are safe and properly labeled. Food and feed 

derived from transgenic products must be in compliance with all applicable legal and regulatory 

requirements. Transgenic products for food and feed may undergo a voluntary consultation process 
73

with the FDA prior to release onto the market. To date, all transgenic crops marketed in the US have 

been the subject of pre-marketing consultations with the FDA (FDA, 2006).

No Action Alternative

Human health is not likely to be affected as a direct or indirect result of the No Action Alternative. 

Other transgenic Bt corn varieties no longer subject to the regulatory requirements of 7 CFR part 340 

or the plant pest provisions of the Plant Protection Act would continue to be available and used as 

food for human consumption. Cry proteins of Bt corn products are not toxic to humans and do not 

have any known allergenic properties for humans (Randhawa et al., 2011). Human exposure to 

5307 corn would be limited to those individuals involved in cultivation under regulated conditions. 

Regulated field trials of 5307 corn would only impact small plots of land with no potential for 

exposure to the general public. Exposure to existing transgenic and non-transgenic corn would not 

change under this alternative.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Human health is not likely to be affected as a direct or indirect result of the Preferred Alternative. The 

donor organism for the source genes used to create eCry3.1Ab is B. thuringiensis, a ubiquitous soil 

bacterium. The eCry3.1Ab protein is derived from a family of Bt proteins that has a long history of 

safe use in food crops (US-EPA, 2001)(updated 2011). 

The Cry proteins of Bt corn products, including 5307 corn, are not toxic to humans and do not have 

any known allergenic properties for humans (Randhawa et al., 2011) ; (US-EPA, 2011d). A 

discussion on the mechanism of action for eCry3.1Ab, its spectrum of activity, and its lack of toxicity 

to non-coleopteran species is presented in the Petition (Syngenta, 2011c); and the Safety and 

Nutritional Assessment (Syngenta, 2011a), 2011a; Appendix B). A comprehensive assessment of the 

safety of eCry3.1Ab demonstrated that the protein is nontoxic to mammals and unlikely to be a food 

allergen (US-EPA, 2001);(Syngenta, 2011c). The eCry3.1Ab protein does not share significant 

amino acid similarity with known protein toxins, is nontoxic to mice at a very high dose, is rapidly 

degraded in simulated mammalian gastric fluid, and the insecticidal mode of action is not relevant to 

mammals. The eCry3.1Ab protein is not likely to become a food allergen because it is not derived 

from a known source of allergenic proteins, it does not have significant amino acid sequence identity 

to known allergenic proteins, it is rapidly degraded in simulated mammalian gastric fluid, it is not 

glycosylated, and it is labile upon heating at temperatures of 37oC and above Syngenta, 2011). 

The PMI marker protein present in 5307 corn raises no human health concerns with respect to 

toxicity or allergenicity (US-EPA, 2004). The PMI protein does not share significant amino acid 

homology with known protein toxins, it is nontoxic to mice at a very high dose, and it is rapidly 

degraded in simulated mammalian gastric fluid. PMI is not likely to become a food allergen because 

it is not derived from a known source of allergenic proteins, it does not have any significant amino 

acid sequence identity to known allergenic proteins with implications for its allergenic potential, it is 

rapidly degraded in simulated mammalian gastric fluid, it is not glycosylated, and it is labile upon 

heating at temperatures of 37oC and above.
74

Under the preferred alternative, the general public would primarily come in contact with the 

introduced transgenic proteins (i.e., eCry3.1Ab and PMI) through dietary exposure to food and 

products derived from 5307 corn, although most processed products would contain no detectable 

eCry3.1Ab or PMI residues. Laboratory, greenhouse, growth chamber, and field investigations with 

5307 corn confirmed that there were no changes in seed, pollen, plant phenotype, or composition 

parameters suggestive of increased plant pest risk. Assessments of the grain and forage from multiple 

US field sites demonstrate that 5307 corn is nutritionally and compositionally equivalent to, and as 

safe and nutritious as, its non-transgenic counterpart (Syngenta, 2011c). Syngenta initiated a 

voluntary pre-market consultation process with FDA and submitted a Safety and Nutritional 

Assessment (Appendix B (Syngenta, 2011a)). The assessment demonstrated a lack of toxicity and 

allergenicity of 5307 corn for human and animal consumption. 

4.5.2 Animal (Livestock) Health

As described in Section 2.5.2, Animal (Livestock) Health, livestock ingestion of feed from transgenic 

crops, with subsequent human ingestion of livestock food products, is a potential concern about 

transgenic crops.

No Action Alternative

Animal (livestock) health would not be affected as a direct or indirect result of the No Action 

alternative. Section 2.2.1, Production and Yield, explains that approximately 39 percent of the corn 

produced in the US is used for livestock feed and most of the corn used currently for livestock feed is 

transgenic. As discussed in Section 4.6.1, Human Health, Cry proteins are not expected to be 

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

gastrointestinal flora is expected. Insecticidal Cry proteins from B. thuringiensis have a long history 

of safe use in feed crops (US-EPA, 2001). Their modes of action are highly specific within narrow 

ranges of related insect species, and are not relevant to mammals, including domestic livestock, or 

other vertebrates. Cry proteins also have a history of safe consumption in the context of other food 

and feeds (US-FDA, 2010). Additionally, the selectable marker PMI protein produced by 5307 corn 

plants is exempt from food and feed tolerances (US-EPA, 2004).

Livestock would not be exposed to 5307 corn if it continues to remain a regulated article. Other 

transgenic Bt corn varieties no longer subject to the regulatory requirements of 7 CFR part 340 or the 

plant pest provisions of the Plant Protection Act will continue to be available and used as feed for 

animal consumption. Exposure to existing transgenic and non-transgenic corn would not change 

under this alternative. Regulated field trials of 5307 corn would only impact small plots of land with 

no potential for exposure to livestock.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available.

Animal (livestock) health is not likely to be affected as a direct or indirect result of the Preferred 

Alternative. Under the preferred alternative, livestock would primarily come in contact with the

introduced eCry3.1Ab and PMI proteins in 5307 corn through feed products derived from 5307 corn. 

The eCry3.1Ab protein is derived from a family of Bt proteins that has a long history of safe use in 

food crops. There are no animal health or environmental concerns with respect to toxicity or 

allergenicity of eCry3.1Ab or PMI (US-EPA, 2004); (Syngenta, 2011a) Appendix B). Exposure to 
75

existing transgenic and non-transgenic corn would not change under this alternative. A compositional 

analysis concluded that forage and grain from 5307 corn hybrids are considered similar in 

composition to forage and grain from both the non-transgenic comparator and conventional corn 

hybrids (Syngenta, 2011c). Event 5307 corn will be as safe and nutritious as conventional corn for 

livestock. Syngenta initiated a voluntary pre-market consultation process with FDA and submitted a

Safety and Nutritional Assessment for 5307 corn in January 2011 (Syngenta, 2011a); Appendix B). 

The assessment demonstrated a lack of toxicity and allergenicity of the eCry3.1Ab and PMI proteins 

in 5307 corn for human and animal consumption. No adverse impacts to livestock, either directly or 

indirectly, are expected from a determination of nonregulated status for 5307 corn.

4.5.3 Worker Safety

As described in Section 2.5.3, Worker Safety, pesticides, including US-EPA restricted use 

insecticides and herbicides, are used on most corn acreage in the US. The EPA’s Worker Protection 

Standard (WPS) (US-EPA, 1992); 40 CFR Part 170.1, Scope and Purpose) requires employers to 

take actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and 

pesticide handlers. The WPS contains requirements for pesticide safety training, notification of 

pesticide applications, use of personal protective equipment, restricted entry intervals following 

pesticide application, decontamination supplies, and emergency medical assistance.

The restrictions and precautions for worker safety associated with several conventional insecticides 

for rootworm control include:

1. Protective clothing (chemical-resistant gloves and other skin protection, eye protection, 

respirators, etc.) or other measures (closed-system applications) to minimize applicator 

exposure;

2. Minimum worker reentry intervals post application; and

3. Minimum preharvest intervals post application.

No Action Alternative

During agricultural production of corn, agricultural workers and pesticide applicators may be 

exposed a variety of US-EPA -registered pesticides during application of these chemicals to crops. 

These chemicals would be expected to include those products currently used for insect pest and plant 

pest management. Under the No Action Alternative, exposure to these agricultural chemicals during 

corn production would remain the same as under current conditions.

Agricultural workers and pesticide applicators would continue to be exposed to a variety of USEPA -registered pesticides such as those approved for control of corn rootworm (Table 4-1) under the 

No Action alternative. Chemical insecticide use rates would likely continue to decrease as a result of 

the continued use of insect-resistant transgenic corn products. Large-scale cultivation of transgenic Bt 

corn has increased since its introduction in 1996. A number of studies indicate that the application of 

pesticides has decreased since the introduction of transgenic crops (Kleter et al., 2007), reducing 

exposure of agricultural workers to the hazards of pesticide mixing, loading and application.

US-EPA requires several types of data for Bt PIPs to provide a reasonable certainty that no harm to 

workers will result from the aggregate exposure of these proteins. None of the Bt proteins registered 
76

as plant pesticides in the US are toxic or have been shown to have any significant effect on humans

(US-EPA, 2010b).

Approved transgenic Bt corn cultivars would continue to be used even if 5307 corn continues to 

remain a regulated article. Regulated field trials of 5307 corn would only impact small plots of land 

with limited potential for exposure to agricultural workers. Under the No Action alternative, 

agricultural workers and pesticide applicators would continue to be exposed to a variety of chemicals.

Table 9: Commercially Available Corn Breeding Stack Combinations with Insect Control Traits

Product Event Names Resistance/Tolerance Traits

Agrisure® GT/CB/LL Bt11/GA21 Lepidoptera, glyphosate, glufosinate

Agrisure VipteraTM 3110 Bt11/MIR162/GA21 Lepidoptera, glyphosate, glufosinate

Agrisure CB/LL/RW Bt11/MIR604 Lepidoptera, rootworm, glufosinate

Agrisure 3000GT Bt11/MIR604/GA21 Lepidoptera, rootworm, glyphosate, 

glufosinate

Agrisure Viptera 3111 Bt11/MIR604/MIR162/GA21 Lepidoptera, rootworm, glyphosate, 

glufosinate

Agrisure 3122 Bt11/MIR604/DAS 59122-7/TC1507 Rootworm, Lepidoptera, glyphosate, 

glufosinate

Syngenta GT/RW MIR604/GA21 Rootworm, glyphosate

YieldGard Corn Borer with 

Roundup Ready® Corn 2 

(RR2)

MON 810/NK603 Lepidoptera, glyphosate

YieldGard 

Rootworm/RR2

MON 863/NK603 Rootworm, glyphosate

Genuity VT Double 

PROTM

MON 89034/NK603 Lepidoptera, glyphosate

YieldGard Plus MON 810/MON 863 Lepidoptera, rootworm

YieldGard Plus/RR2 MON 810/MON 863/NK603 Lepidoptera, rootworm, glyphosate

YieldGard VT Triple® 

and 

Genuity VT Triple

MON 810/MON 88017 Lepidoptera, rootworm, glyphosate

(Genuity) Smart Stax MON 89034 /MON 88017/ TC1507/DAS59122-7Lepidoptera, rootworm, glyphosate, 

glufosinate

Genuity VT Triple PRO MON 89034/MON 88017 Lepidoptera, rootworm, glyphosate

Herculex IRR2 TC1507/NK603 Lepidoptera, glyphosate, glufosinate

Herculex RW/RR2 DAS 59122-7/NK603 Rootworm, glyphosate, glufosinate

Herculex XTRA TC1507/DAS 59122-7 Lepidoptera, rootworm, glufosinate

Herculex XTRARR2 TC1507/DAS 59122-7/NK603 Lepidoptera, rootworm, glyphosate, 

glufosinate

Optimum AcreMax 1 Seed blend of 90% TC1507/DAS-59122-7/ 

NK603 and 10% TC1507/NK603 refuge 

seed

90% Lepidoptera, rootworm, glyphosate; 

10% Lepidoptera, glyphosate

Optimum AcreMax RW Seed blend of 90% DAS-59122/NK603 

and 10% NK603 refuge seed

90% rootworm, glyphosate; 10% 

glyphosate

Sources NCGA website http://ncga.com/know-before-you-grow/ and Pioneer website 

http://www.pioneer.com/home/site/about/products/product-traits-technology/optimum-acre-max/
77

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. A determination of non-regulated status of 5307 corn would provide growers 

with an alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Similar to the No Action alternative, US-EPA-registered pesticides that are currently used for corn 

production would continue to be used by growers under the Preferred Alternative. Agricultural 

production with 5307 corn does not require any change to the agronomic practices or chemicals 

currently used (i.e., pesticides) for conventional corn. Therefore, worker safety issues associated 

with the agricultural production of 5307 corn would remain the same as those under the No Action 

Alternative.

As described in Section 4.2.2, Insect Management, trends in reduced insecticide use are likely to 

continue as a direct result of the Preferred Alternative. The safety and convenience of planting insectprotected corn compared to the application of conventional insecticides are consistently cited by 

growers as benefits of transgenic crops (Brookes and Barfoot, 2011). The further adoption of Bt 

transgenic varieties, including 5307 corn, would continue to extend these benefits to workers. If 5307 

corn should replace CRW resistant varieties that are showing increased rootworm damage, less 

insecticide would need to be used to augment these older CRW resistant varieties. As a result,

agricultural workers and pesticide applicators would likely benefit from the use of 5307 corn due to a 

reduction in the use of corn rootworm insecticide applications and the number of acre-treatments per 

year.

4.6 Socioeconomics

This section describes the potential impacts to the domestic economic environment, trade economic 

environment, and social environment that may result from the No Action and Preferred Alternatives.

4.6.1 Domestic Economic Environment

As described in Section 2.6.1, Domestic Economy, domestic demand for corn in the US comes 

primarily from its use for feed, ethanol production, food, and seed. In 2011, transgenic products 

comprised 88 percent of the planted corn to satisfy this demand (USDA-ERS, 2011b). The transgenic 

traits include herbicide tolerance, insect resistance, and other traits. Approximately 65 percent of the US 

corn crop in 2011 was comprised of Bt corn (USDA-ERS, 2011b). Overall, harvest security and quality 

is better with Bt corn. Farm income is positively impacted by Bt corn by reducing production costs or 

increasing revenues. Pest-resistant corn generally has a positive impact on farm income due to cost 

savings from reduced pesticide use (Brookes and Barfoot, 2011).

Section 2.2.2, Insect Management, explains that the corn rootworm family is one of the most 

damaging corn pests, and was often referred to as the “billion dollar bug” due to annual yield losses 

and control costs (Metcalf, 1986), prior to the introduction of transgenic cultivars for rootworm 

control, which began in 2003. Seed companies have developed transgenic crops with corn rootworm 

resistance specifically to address this economic loss. Four corn rootworm-resistant cultivars 

(MON 863, DAS 59122-7, MON 88017 and MIR604 corn) are currently available to corn breeders to 

control this economically important pest (Table 2-1).

No Action Alternative
78

The domestic economy would not be affected as a direct or indirect result of the No Action 

alternative. Growers would continue to make choices to plant certain corn varieties and use certain 

crop rotation practices based on factors such as yield, weed and disease pressures, cost of seed and 

other inputs, technology fees, worker safety, potential for crop injury, and ease and flexibility of the 

production system (Olson and Sander, 1998); (Gianessi, 2005). The No Action alternative would not 

affect available options for growers and therefore not affect the domestic economy. Event 5307 corn 

would remain a regulated article and would require an APHIS permit or notification for release into 

the environment. As noted in section 4.2.3., cultural methods will continue to be used by organic and 

specialty growers to confine pollen flow, and thus gene movement, and no expectation that continued 

field trials of this or other GE crops will result in any additional adventitious presence of GE traits 

into corn. Regulated field trials of 5307 corn would only impact small plots of land with no impact 

on the domestic economy. 

Preferred Alternative

The domestic economic environment could be positively affected as a direct and indirect result of the 

Preferred Alternative. Under the preferred alternative, growers would have an additional tool to use 

against corn rootworms that would directly reduceeconomic loss from this pest. The Preferred 

Alternative could indirectly result in economic benefit from increased competition in the seed market. 

The availability of multiple corn rootworm-resistant products could increase grower choice and price 

competition, potentially resulting in lower seed prices for growers. The availability of 5307 corn 

could also assist in managing insect resistance to existing Bt corn products for corn rootworm control. 

To the extent that the planting of 5307 corn results in a decrease of insecticide applications in those 

circumstances when corn rootworm that have developed resistance to existing Bt corn products, or 

results in an increase in yields, farms adopting 5307 corn might experience an increase in net income. 

Event 5307 corn hybrids demonstrated an average grain yield advantage of 63 bushels per acre over 

control hybrids in the presence of intense larval rootworm pressure during field tests (Appendix A; 

this EA, Supplemental Information on Insecticide Use with Traits in Corn ). Growers are expected to 

realize a real-world increase in yield and would therefore likely realize direct economic gain from 

this product (Syngenta, 2011c); and Appendix A, this EA). 

Specialty and Organic Corn. Similar to the no action alternative, a determination of nonregulated 

status of 5307 is not expected to have an adverse impact on specialty or organic corn products. As 

noted in section 4.2.3., organic corn production is increasing along with that of commodity corn. A 

determination of nonregulated status of 5307 corn is unlikely to significantly impact specialty or 

organic farmers that choose not to plant or sell corn products produced through genetic engineering 

or other non-organic production systems. Despite the wide-spread adoption of conventional and GE 

corn in the U.S. that amounted to 99.8 percent of total corn production in the U.S. in 2007, organic 

corn production has also continued to expand in recent years (USDA-ERS, 2010a). This continued 

expansion of organic corn acreage, though minor relative to non-organic national and state corn 

production, reinforces the capacity of current organic system plans to avoid use of excluded methods 

(and thus, loss of NOP certification) and the efficacy of these plans to increasingly produce 

agricultural products to meet demand of target markets in spite of the overwhelming presence of nonorganic farming systems. The overwhelming majority of organic growers have no concerns that 

admixture of organic seed with GE traits was an issue for their organic production (88% in an

Organic Seed Alliance survey; (Organic-&-Non-GMO-Report, 2010b). Additionally, 5307 corn will 

not increase the possibility of adventitious presence of GE seed in organic corn or specialty 

production to any greater extent than that of other, similar varieties, because its agronomic production 
79

processes and biological properties of the variety are not different from other corn rootworm resistant 

varieties currently available and being used by growers.

4.6.2 Trade Economic Environment

As described in Section 2.6.2, Trade Economy, the primary US corn export destinations are also the 

largest world importers of corn and do not have major barriers for importing food or feed commodities 

produced from transgenic crops, including those with insect resistance traits. Nevertheless, import of each 

specific trait requires separate application and approval by the importing country. Developing countries’ 

demand for corn has increased steadily for the past three decades, propelling the global trade market 

above 70 million metric tons every year since 1999/2000 (USDA-ERS, 2009b). Corn imports to 

European Union countries have declined steadily since the Common Agricultural Policy limited grain 

imports and EU membership has expanded (USDA-ERS, 2011c).

No Action Alternative

The trade economic environment would not be affected as a direct or indirect result of the No Action 

alternative. Genetically modified corn varieties, including Bt varieties, would continue to be 

developed and available in the trade market. Event 5307 corn would remain a regulated article and 

would require an APHIS permit or notification for release into the environment. Regulated field trials 

of 5307 corn would only impact small plots of land with no impact on the worldwide corn trade.

Preferred Alternative

The trade economic environment would not be affected as a direct or indirect result of the Preferred 

Alternative. A determination of non-regulated status of 5307 corn would provide growers with an 

alternative to other transgenic corn rootworm-protected varieties that are currently available. 

Worldwide market conditions and destination country approval of transgenic crop commodities would 

continue to be factors for international corn prices, without regard to the presence or absence of 

5307 corn on the market. Deregulating 5307 corn would not adversely impact the trade economy and 

may potentially enhance it through more efficient production of corn supplies worldwide. 

Syngenta has applied to Canadian agencies for approval of the unconfined environmental release and 

food and feed use of corn commodities and processed goods containing 5307 corn (Syngenta, 2011c). 

To avoid adversely affecting international trade in corn commodities exported from the US (and 

Canada), regulatory filings for 5307 corn import approvals have been made in Japan, South Korea, 

Taiwan, Australia/New Zealand, South Africa, Columbia and the European Union. Applications are 

planned for additional countries including Mexico, China, the Philippines, Indonesia, and Russia.

(Syngenta, 2011c), section I.C.3). The trade economic impacts associated with a determination of 

nonregulated status of 5307 corn are anticipated to be similar to the No Action alternative.

4.6.3 Social Environment

As described in Section 2.6.3, Social Environment, farmers have a range of options in agronomic 

practices, seed products to choose from, and opportunities for sale to customers. Consumers have a 

range of corn products to choose from. 

According to data from the 2010 Agricultural Income and Finance Outlook, farms growing corn are 

expected to benefit from increased sales at higher prices. Increases in prices are a function of 

anticipated increases in domestic uses, including bioethanol, as well as exports for feed (USDA-ERS, 
80

2010b). Prices received for feed grains, including corn, increased 107% from 2003 to 2008 as a 

direct result of the increase in ethanol production (USDA-ERS, 2010; USDA-ERS, 2011b). During 

this same time period, production costs have increased also, with the cost of seed rising 67% (USDAERS, 2011b). The USDA projected that increases in average income for corn growers over 14% in 

2010 as a direct result of an increase in expected cash receipts while expenses remained somewhat 

stable (USDA-ERS, 2011b).

No Action Alternative

The social environment would not be affected as a direct or indirect result of the No Action 

alternative. Event 5307 corn would remain a regulated article and would require an APHIS permit or 

notification for release into the environment. The cropping and marketing decisions made by corn 

growers are unlikely to be influenced by the selection of this alternative. Consumers would continue 

to have a range of corn products available to choose from. Regulated field trials of 5307 corn would 

only impact small plots of land with no impact on the social environment.

Preferred Alternative

Overall impacts of a determination of nonregulated status of 5307 corn would be similar to the No 

Action Alternative. Event 5307 corn would provide growers with an alternative to other transgenic 

corn rootworm-protected varieties that are currently available. The social environment would not be 

affected as a direct or indirect result of the Preferred Alternative. Event 5307 corn is not expected to 

confer any competitive advantage in terms of weediness or to extend the range of cultivation outside 

of existing cultivation areas. A determination of nonregulated status of 5307 corn is not expected to 

significantly expand the number of corn acres and corn acreage is expected to remain relatively 

stable. No changes to farms producing corn feed grains would be likely, nor would changes to 

income of these farms, or of government payments to these farms. Consumer choice would be 

unchanged by a determination of nonregulated status of 5307 corn.
81

5 CUMULATIVE EFFECTS

This section describes the potential cumulative effects that may result from the Preferred Alternative. 

The CEQ regulations define a cumulative effect as “the impact on the environment which results 

from the incremental impact of the action when added to other past, present, and reasonably 

foreseeable future actions regardless of what agency (Federal or non-Federal) or person undertakes 

such other actions. Cumulative effects can result from individually minor but collectively significant 

actions taking place over a period of time.” (CEQ, 1978; 40 CFR Part 1508, Section 1508.7, 

Cumulative impact).

5.1 Methodology and Assumptions

Based on the information provided in Sections 4.2 through 4.6, which is summarized in Table 3-1, 

the Preferred Alternative would not adversely impact the physical, natural, social, or economic 

environment. Furthermore, as discussed throughout this section, there are no past, present or 

reasonably foreseeable actions that, in aggregate with the Preferred Alternative would adversely 

affect these resources. 

5.2 Reasonably Foreseeable Future Actions

Transgenic corn varieties marketed in the US today typically contain multiple transgenic traits, some 

of which have been combined by traditional breeding between different cultivars that are no longer 

subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. In the event that 

APHIS reaches a determination of non-regulated status of 5307 corn, this corn variety could

potentially be combined with non-transgenic and other transgenic corn cultivars by traditional 

breeding techniques, resulting in a plant variety that, for example, may be resistant to one or more 

herbicides and contain other insect-resistance traits that are no longer subject to the regulatory 

requirements of 7CFR Part 340. APHIS’s regulations at 7 CFR Part 340 do not provide for agency 

oversight of transgenic corn varieties that are no longer subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR part 340 unless it can be positively shown that such stacked 

varieties were to pose a likely plant pest risk. To date, none of the GE corn varieties that have 

been determined to no longer be regulated articles pursuant to Part 340 and the Plant Protection 

Act and used for commercial corn production or corn breeding programs subsequently have been 

found to pose a plant pest risk. 

There is no certainty that 5307 corn will be stacked with any particular non-transgenic or transgenic 

variety (one no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act), as company plans and market demands play a significant role 

in those business decisions. Predicting all potential combinations of stacked varieties that could be 

created using commercially available non-transgenic and transgenic corn cultivars corn cultivars is 

hypothetical and purely speculative. 

Syngenta has indicated (Syngenta, 2011c) that it intends to offer 5307 corn for sale to US growers in 

two combinations comprised of the insect protection and herbicide tolerance traits; these traits are

listed as A and B in Table 10 (immediately following below). Syngenta has requested authorization 

from the US-EPA for distribution of these stacked products (Syngenta, 2011a); Appendix A of the 

EA), with specific combinations of insecticidal traits for each product.
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Table 10: Planned Stacking Combinations*

Cultivar Traits Combination

5307 Corn rootworm resistant A, B

Bt11 Lepidopteran resistant and glufosinate tolerant A, B

MIR604 Corn rootworm resistant A, B

TC1507 Lepidopteran resistant and glufosinate tolerant A, B

GA21 Glyphosate tolerant A, B

MIR162 Lepidopteran resistant B

* Stacks with specified traits are marked as a “A” Combination (first four traits) or as a “B” combination (all traits)

The proposed hybrids A and B listed in Table 5-1 would combine two corn rootworm-active proteins 

(eCry3.1Ab from 5307 corn and mCry3A from MIR604 corn) that each provide control of western, 

northern, and Mexican corn rootworms. The hybrids would also combine lepidopteran-specific Btderived proteins that would deliver broad-spectrum control of economically important lepidopteran 

pests. Finally, these hybrids would also express traits that confer tolerance to glyphosate and 

glufosinate herbicide applications as weed-control options. Apart from 5307 corn, all of the cultivars 

derived from other transgenic events in these breeding stacks are no longer subject to the plant pest 

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

For purposes of cumulative impact analysis, reasonably foreseeable future actions include the 

potential for stacking certain already approved transgenic corn cultivars with 5307 corn, or for 

creating new stacks with similar combinations of traits. The analysis will consider those insect 

resistance and herbicide tolerance traits found in the breeding stacks currently approved for sale or use 

in the US, as listed in Table 9.

5.3 Cumulative Effects Analysis

A cumulative impact may be an effect on the environment which results from the incremental 

impact of the proposed action when added to other past, present, and reasonably foreseeable future 

actions. Among the cumulative impacts considered are stacking of the Syngenta 5307 corn with 

herbicide resistance traits, and for pyramiding with additional CRW resistance traits, because 

Syngenta plans to market 5307 in specified combinations (Syngenta, 2011c).

5.3.1 Corn Production

GE corn varieties are planted on the majority of corn acres in the U.S. (88 percent of acreage in 2011) 

(USDA-NASS, 2011a). Acreage of transgenic corn planted with herbicide-tolerant varieties declined 

in 2008, although corn varieties with insect resistance, whether alone or stacked with an herbicide 

tolerance trait, are planted more readily than those varieties conferring tolerance to herbicides alone 

(see, analysis of petition DP-098140-6: (USDA-APHIS, 2009 )). Stacked products combining insect 

resistance and herbicide tolerance (and potentially other traits) are likely to continue to be introduced

(for example, Monsanto has in development an RNA interference product with rootworm resistance 

(Fraley, 2012); (Ostlie, 2011b). Regardless if the regulatory status of 5307 corn changes, it is likely 

that a trend towards increased multiple insect protection traits will continue, since these afford 

growers increased convenience and protection.
83

Event 5307 corn and any hybrid progeny produced from it including eCry3Ab inclusion within stacks 

of other traits will not require significantly different crop production practices compared to other corn 

varieties that are currently available to growers. Therefore, a determination of nonregulated status of 

5307 corn is not anticipated to have any cumulative effect on existing corn hybrids when 

incorporated with the eCry3Ab trait. As a result, no cumulative effects would be expected on 

production and yield, agronomic practices such as pesticide use, crop rotation, tillage, irrigation, 

disease management, or weed management related to US corn production or on specialty and organic 

crops or to raw and processed corn.

Insect Management. As noted in Table 6 and discussed in Section Agronomic Practices, 

Agronomic Practices, the Preferred Alternative is expected to have the possible effect of reducing 

insecticide use. The past and current actions potentially contributing to cumulative effects on this 

resource are the pest management strategies that include conventional insecticide and herbicide use, 

crop rotation practices, and the introduction of transgenic corn varieties and their increasing use. The 

array of transgenic corn cultivars currently available (2012 growing season) for insect pest 

management is listed in Table 9: Commercially Available Corn Breeding Stack Combinations with 

Insect Control Traits. The future actions potentially contributing to a cumulative effect are the 

combination of 5307 corn cultivars exhibiting Coleopteran resistance that are stacked in transgenic 

corn with Lepidopteran resistance or herbicide tolerance or both, as listed in Table 10.

Insecticide use. Corn rootworm has evolved resistance to some chemical insecticides and also to crop 

rotation practices that have historically been used to control these economically destructive pests

(Van Rozen and Ester, 2010). As described in Section 2.2.2, Insect Management, use of conventional 

(chemical) pesticides to control corn rootworm has been reduced since the introduction of transgenic 

Bt corn for insect control. As described in Section 4.2.2, Insect Management, insecticide use as an

alternative to use of CRW resistant hybrids is likely to continue to be reduced under the preferred 

alternative. If single rootworm resistance traits should show continuing susceptibility to high CRW 

pressure, then some growers may see continuing need to treat corn at planting or post-planting with 

only insecticides and avoid use of Bt traits. Alternatively, growers may decide to use insecticides 

with single trait Bt corn to respond to high populations of CRW, as suggested by corn extension 

entomologists (Ostlie, 2011b); (Gray, 2011b). As earlier noted, sites of failure of Bt-expressing 

hybrids are infrequent, and are associated with growing areas where continuous corn has been a 

multiple-season pattern (Gassmann et al., 2011). 

Bt protein resistance. A key issue related to the use of Bt corn for insect control is delaying or 

avoiding the development of resistance to Bt proteins in insect pests. The widespread use of 

transgenic Bt corn could generate selection pressures for insect resistance (Tabashnik et al., 2008). 

However, there is no indication that the widespread use of insect resistant Bt crops havecaused any 

overall failure of these hybrids, even though as earlier noted, four states have reported such events. 

Certain fields with a history of corn-on-corn rotations or high rootworm populations have 

experienced such failures but often with hybrids expressing one trait, Cry3Bb1 (Gassmann et al., 

2011); (Gray, 2011a). 

IRM strategies have been successfully developed and used to reduce the likelihood of developing Bt

insect resistance, including the US-EPA requirement that growers plant nearby refuges with corn

varieties lacking the Bt trait. Although one recent study indicates that in some fields in Iowa, western 

corn rootworm may have developed resistance to Cry3Bb1 protein (Gassmann et al., 2011) under 

high rootworm pressure, such resistance has not yet been confirmed (Monsanto, 2011a) and detailed 
84

analysis of possible genetic basis of the resistance has not been completed. No evidence has been 

provided that suggests that the control failures are affecting other CRW resistance traits (Cry 34/35, 

(Ostlie, 2011a), or MIR 604, (Hibbard et al., 2011) ; (Gassmann et al., 2011). New CRW resistance 

traits are in development (Ostlie, 2011b); (Gassmann et al., 2011) and pyramids of two transgenic 

corn traits with different modes of action against the target pest should limit the potential for 

resistance to develop to any one product (Tabashnik et al., 2008). Event 5307 could be stacked with 

a CRW resistance to obtain this desired effect. Syngenta’s MIR604 rootworm-resistant cultivar may 

have a different mode of action than 5307 corn (Walters et al., 2010) and thus supports the rationale 

for a pyramided product having greater ability to disrupt development of CRW resistance.

Event 5307 corn could provide corn growers with an additional trait that could be rotated with 

existing traits in the marketplace, which include four other corn rootworm-control cultivars. Most of 

these traits may be pyramided, and new corn varieties might be constructed with multiple 

combinations to avoid overuse of any one pair of traits in a corn-growing area. Event 5307 corn 

could allow additional combinations for more effective IRM strategies. Because the eCry3.1Ab 

protein operates via a unique mode of action, introduction of the 5307 corn into hybrid pyramids

could also extend the useful life of the other commercially available corn rootworm-protected 

products (i.e., the PIPs Cry3Bb1, Cry34Ab1/ Cry35Ab1, and mCry3A) (Syngenta, 2011c); Appendix 

A of this EA). As noted in the petition, Syngenta 5307 trait would only be deployed as a pyramided 

and stacked product Syngenta 2011c (Syngenta, 2011c). 

Increased use of transgenic Bt corn has been correlated with reduced use of or reliance on insecticides 

to control corn rootworm. Under high CRW pressure, Bt hybrids may sometimes be correlated with 

higher corn yields than can typically be achieved with insecticides alone, but may not provide an 

advantage under low to moderate CRW pressure (Ma and Subedi, 2005) ; (Ma et al., 2009) ; (Tinsley 

et al., 2011). Thus, when combined with past, present, and reasonably foreseeable future actions, the 

cumulative effects of the Preferred Alternative may result, in some cases, in an increase in corn 

yields, further reduction of insecticide use, and a reduced likelihood that corn rootworm populations

will develop resistance to Cry proteins, extending the effectiveness of these tools.

Weed Management. Herbicide-tolerant transgenic corn cultivars have been developed to allow use 

of herbicides to control weeds without harming the crop. As described in Section 2.2.2.5, Weed 

Management, herbicide-tolerant corn has been widely adopted by growers in North America. 

Currently available transgenic herbicide-tolerant corn cultivars include multiple glyphosate- or 

glufosinate- (phosphinothricin) tolerant cultivars (USDA-APHIS, 2011b).

In 2011, approximately 72 percent of the US corn crop was planted to transgenic varieties that were 

herbicide tolerant (USDA-ERS, 2011a). Over-reliance on herbicide-tolerant crops and single 

herbicides may under certain conditions promote the development of herbicide-tolerant weeds

(Johnson et al., 2009), although neglect of other strategies to suppress weeds, such as cultural 

controls, multiple modes of action, and crop rotation are likely equal contributors to weed resistance 

(Beckie, 2006). Weeds can potentially survive in crop production systems because of natural 

tolerance to the chemical(s) and because of growth types or life cycles that help them avoid being 

treated, such as some winter annual weed species. As described in Section 2.2.2.5, Weed 

Management, some weeds have also developed herbicide tolerance because the increased use of 

herbicide-tolerant corn has encouraged some growers to use predominately one herbicide and fail to 

use standard practices to prevent weed herbicide resistance that were common before herbicide 

tolerant crops were commercialized. Weed resistance management training to reduce the potential for 
85

weeds to develop tolerance to herbicides has been made available by the Weed Science Society of 

America in web-based training and other formats to growers and extension trainers and is readily 

accessible (Ohio-State-Extension, 2011). Because there are numerous herbicides available, including 

ones such as triazine class herbicides (including atrazine) as well as transgenic corn varieties tolerant 

to two different herbicides available, growers have the potential to rotate herbicide use, rather than 

relying on a single herbicide.

Herbicide Use. Event 5307 corn does not have an herbicide tolerance trait. However, Syngenta has 

indicated that 5307 will likely be stacked with other transgenic corn cultivars that do have herbicide 

tolerance traits (Table 5-1). Weed management methods would generally follow-current practice for 

similar traits already available in commercial hybrid seed. With the proposed stacked product that 

has been identified by Syngenta, including two available traits for herbicide tolerance, growers could 

continue using predominantly glyphosate for weed control, or glufosinate for resistant weeds, or use 

glyphosate and glufosinate separately and sequentially on the same crop. The two herbicides could 

also be used alternately in consecutive crop production years to optimally manage weed resistance. It 

should be noted that glufosinate resistant corn is already available, so growers can already alternate 

glufosinate tolerance with glyphosate tolerance in rotations; significant changes in glufosinate use in 

corn would not be expected.

As described in Section 2.2.2, Weed Management, glyphosate application rates increased slightly 

between 2005 and 2010 and it is reasonable to conclude that they will continue to do so. Weeds may 

continue to develop tolerance to herbicides, as with any crop and weed management system. 

Stacking 5307 corn with herbicide tolerance traits is unlikely to significantly change current trends in

herbicide use and increasing weed tolerance to herbicides. When combined with the past, present, 

and reasonably foreseeable future actions, the Preferred Alternative would have a negligible 

cumulative effect on herbicide use or weed tolerance to herbicides.

Specialty or Organic Corn Production. A determination of nonregulated status of 5307 corn will 

not change market demands for corn produced through organic methods or specialty corn crops. A 

determination of nonregulated status of 5307 corn will add another GE corn variety to the 

conventional corn market. Conventionally produced corn (including GE corn) represents the vast 

majority of corn in states that produce organic corn, and a determination of nonregulated status of 

Syngenta 5307 corn is not anticipated to significantly increase GE corn production in these areas. 

Event 5307 corn should not present any new and different issues and impacts for specialty or organic 

corn producers and consumers. According to the petition, agronomic trials conducted in a variety of 

locations in the U.S. demonstrated that 5307 corn is not significantly different in plant growth, yield, 

and reproductive capacity from its nontransgenic counterpart (Syngenta, 2011c). No differences 

were observed in pollen diameter, weight, and viability. Therefore, 5307 corn is expected to present 

a no greater risk of cross-pollination than that of existing corn cultivars. The practices currently 

employed to preserve and maintain purity of specialty and organic production systems would not be 

required to change to accommodate the production of 5307 corn.

5.3.2 Physical Environment

A determination of nonregulated status of 5307 corn is not anticipated to have any direct or indirect 

cumulative effect on water quality or use; soil; air quality; or climate. A determination of nonregulated status of 5307 corn would provide growers with an alternative to other transgenic corn 

rootworm-protected varieties that are currently available. A determination of nonregulated status 
86

for of 5307 corn is not expected to alter the range of corn cultivation as the new transgenic trait 

(rootworm resistance) does not otherwise change the plant’s agronomic performance compared to 

non-transgenic varieties (Syngenta, 2011c). Agronomic practices such as pesticide use, fertilizer 

use, crop rotation, tillage, irrigation, disease management, or weed management for 5307 corn are 

similar to other corn varieties that are currently available for use by growers.

5.3.3 Biological Environment

A determination of nonregulated status of Syngenta 5307 corn is not anticipated to have any direct or 

indirect cumulative effect animals, plants, soil microorganisms or biodiversity. A determination of 

nonregulated status of 5307 corn would not substantively change the overall usage of transgenic corn 

products with insect resistance traits. Event 5307 corn is not substantively different in its effects on 

non-target species from other approved insect-resistant corn products with Cry proteins. Other 

approved genetically modified crops containing Cry proteins have been demonstrated to have no 

measurable adverse effects on animals or microbial populations in the soil and would continue to be 

used by growers. Event 4307 corn does not possess weedy characteristics, and is unlikely to 

introgress into wild plants or to corn agriculture. 

Biodiversity. The past and current actions potentially contributing to a cumulative effect on 

biodiversity are the introduction of transgenic corn varieties and their increasing use. The future 

actions potentially contributing to cumulative effects on biodiversity are any combination of 

5307 corn stacked with transgenic corn cultivars exhibiting insecticidal properties or herbicide 

tolerance.

This cumulative effects analysis focuses on potential changes in biodiversity that may result from 

impacts to non-target plants and animals within the agroecosystem. Other aspects of biodiversity 

would not be affected

Several traits expressing different Cry proteins are incorporated into various Bt corn varieties to 

provide insect resistance, including resistance to Lepidopteran and Coleopteran pests. US-EPA

conducted a comprehensive environmental assessment of the registered Bt PIPs in 2001 (US-EPA, 

2001) IIC1 and in four other individual PIPs (e.g., m-Cry3A, (US-EPA, 2010d). Although other Bt

corn cultivars incorporating Cry proteins have been introduced in the intervening 10 years, and many 

of the PIPs in earlier cultivars were re-registered in 2010, the 2001 US-EPA review provides a 

general assessment of the risks to biodiversity associated with Bt corn varieties. Summarizing thenexisting published studies and US-EPA’s reviews of submitted studies on potential Cry protein 

impacts to non-target species (vertebrates and invertebrates), US-EPA has concluded that “the weight 

of evidence from the reviewed data indicate that there is no hazard to non-target wildlife from the 

continued registration of Bt crops” (US-EPA, 2001) section IIC81). Minimal to undetectable adverse 

impacts, and in some cases beneficial impacts, to non-target insect populations were shown (USEPA, 2001). 

New Coleopteran specific Bts however, could have differing activities on nontarget organisms, 

although activities are not tested against one another; GE trait developers individually test for impacts 

on representative vertebrate and invertebrate animals. Because one group of insects that would nost 

likely be affected by rootworm toxins are other Coleopteran insects, non-target beetles such as the 

rove beetles (Staphylinidae) are often used to make assessments of effects on biodiversity. When 

three guilds of rove beetles were examined in fields with vegetative stage Bt-expressing plants, plots 

of DAS 59122-7 (rootworm toxins Cry34Ab1and Cry 35Ab1), DAS 59122-7 X Cry 1F (rootworm 
87

toxin X lepidopteran toxin), and an isogenic control, only the DAS 59122-7 plots were associated 

with a significantly larger activity density of predatory rove beetle larvae than the control or stacked 

hybrid plots, although only 33% larger. Despite this observation, none of the treatment plots, 

including isogenic controls or the insecticide treated controls contained lower activity densities

(Balog et al., 2011). Thus, based on this information it appears that rove beetle biodiversity was not 

impacted by exposure to plant-expressed Bts. 

Pyramiding of multiple rootworm toxins has begun to be studied in field plots (Hibbard et al., 2011).

In these studies the stacking of 5307 corn with Syngenta MIR604 decreased adult rootworm 

emergence across all replications and environments in field test sites when compared to the single 

toxin-expressing hybrids. However, as indicated in the study reports, the two genes responsible for 

resistance in each line are apparently not acting entirely independently, since the numeric product of 

relative percentage survivorship for each line (5307 and for MIR604) should be the same as the 

measured survivorship in the dual toxin corn. However, similar survivorship was not attained. The 

results of the adult emergence study showed neither synergism nor complete additivity. 

The commercial Bts active on rootworm have a history of narrow toxicity, and do not have impacts 

even on related nontarget coleopteran insects (see APHIS’ previous petitions for nonregulated status, 

APHIS 2011b). The two CRW toxin traits proposed for pyramids by Syngenta, 5307 (eCry3.1 Ab) 

and MIR604 (mCry3A) have been assessed for potential to impact nontarget organisms using a 

strategy acceptable to US-EPA (D.Ward, Syngenta, pers. comm. 2011). Although nontarget effects 

are clearly not expected based upon single toxin Bt assessments, possible effects were sought by 

empirical methods to assess antagonism, potentiation, additive toxicity or synergism. Such effects 

can be studied in insects susceptible to the toxin, rather than choosing a large variety of test insects 

none of which likely have any sensitivity to the Cry proteins. These assays have been accomplished 

in the Colorado potato beetle (Syngenta study no. TK 0026862: CBI), and shared with APHIS and 

US-EPA. Incomplete additivity of apparently independent mechanisms leading to mortality were 

demonstrated and it appears that synergism in sensitive organisms does not occur. The conclusion is 

consistent with a determination that nontarget insects are not likely to be impacted, since even in 

sensitive organisms (the Colorado potato beetle), no unexpected synergism to the stacked Cry 

proteins could be demonstrated. 

As noted in section 2.2.2.3, various chemical treatments are applied to seed of the rootworm specific 

corn traits; recently this nearly always includes a systemic neonicotinoid (Smith et al., 2004). When 

species richness within three Coleopteran families was assessed throughout a growing season, no 

differences were detected in fields of isoline and Cry3Bb1 varieties when seeds were treated or when 

rows were conventionally treated with pyrethroids (during the silking stage), although the isoline had 

higher Coleopteran abundances (Leslie et al., 2010). Mortality deriving from exposure of 

Coleopteran species to the neonicotinoid seed treatments had previously been demonstrated in 

laboratory analyses and not from exposure to Cry3Bb1. Specific impacts on certain species from the 

neonicotinoid exposed Coleoptera were not different from those found when these species were 

exposed to pyrethroids by field application. No end-of-growing-season impacts on Coleopteran 

species followed from use of the Cry3Bb1 hybrid crop (Leslie et al., 2010).

Studies have also concluded that the use of Bt crops, rather than broad-spectrum insecticides, could 

allow larger populations of beneficial insects and non-pest herbivores to persist in planted fields

(Pilson and Prendeville, 2004). Yu and colleagues (Yu et al., 2011) following a comprehensive 

survey of Bt-expressing corn hybrids also concluded that these have no direct detrimental effects on 
88

non-target organisms, and these hybrids may allow an increase of beneficial insects and 

consequently, improve natural control of pests.

US-EPA also noted that Bt crops have a positive effect on soil flora compared to non-selective 

synthetic chemical pesticides (US-EPA, 2001). Oliveira and others (Oliveira et al., 2008) have 

detected no changes in organisms or the soil activities surveyed between soils planted to Bt (Cry1Ab) 

crops or to their non-GE isolines. No effects on soil decomposer communities or litter decomposition 

rates from corn plant parts (Cry3Bb-expressing hybrid) buried in soil were detected during a 25 

month analysis (Xue et al., 2011).

In general, applying less toxic herbicides (e.g., glyphosate to glyphosate tolerant crops) may be more 

environmentally beneficial than traditional herbicides with non-GE crops (Pilson and Prendeville, 

2004). However, site specific impacts on a species level basis are not always as clear. However, 

birds that consume weeds targeted by the herbicides could potentially be impacted if the weed seed is

significantly reduced, as for example, granivorous birds in herbicide tolerant corn in farm scale trials 

(Chamberlain et al., 2007). These relationships and the actual impact on biodiversity are difficult to 

determine. For example, one study suggested that reductions in monarch butterfly (Danaus 

plexippus) populations overwintering in Mexico might be attributed in part to loss of host milkweed 

(Asclepias syriaca) plants in the Corn Belt from the extensive use of glyphosate (Brower et al., 

2012). Other studies (Davis, 2012) suggest that monarch populations are very dynamic because of the 

high reproductive potential of this species, and no similar reduction was observed in populations 

studied in the US.

The hybrids under consideration by Syngenta would combine two rootworm-active proteins that each 

provide control of western, northern, and Mexican corn rootworms but do not compete for the same 

binding site in western corn rootworm gut membranes (Syngenta, 2011c). With the proposed 

pyramided product, including two available traits for herbicide tolerance, growers could continue 

using predominantly glyphosate for weed control, or could tank-mix both, or use them sequentially 

on the same crop, or use them alternately in consecutive crop production years to optimally manage 

weed resistance. Used according to US-EPA designated conditions, impacts on biodiversity of plant 

species should be no different than that expected from impacts of the two individual herbicide traits. 

Under these practices, development of resistant weeds could decrease, which could have small but 

not significant impacts on plants associated with the margins of the agroecosystem. 

Section 5.3.2. Corn Production, subsection Herbicide Use, explains that stacking 5307 corn with 

herbicide-tolerance traits may incrementally increase the use rates or displacement of certain 

herbicides, potentially contributing but to a negligible degree to increased weed tolerance to 

herbicides. Stacking with other insect-resistance traits would potentially decrease broad-spectrum 

insecticide use, cumulatively reducing the selection pressure for insect resistance and adverse impacts 

to non-target insects. 

5.3.4 Public Health

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

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

with effects of the Preferred Alternative to affect public health, work safety or animal feed. A 

determination of non-regulated status of 5307 corn would provide growers with an alternative to 

other transgenic corn rootworm-protected varieties that are currently available. The eCry3.1Ab 
89

protein is derived from a family of Bt proteins that has a long history of safe use in food crops (USEPA, 2001) (updated 2011). Worker safety issues related to agronomic practices and the use of 

pesticides during agricultural production of 5307 corn would remain the same under both 

alternatives. Agricultural production with 5307 corn does not require any change to the agronomic 

practices or chemicals currently used (i.e., pesticides) for conventional corn.

5.3.5 Socioeconomics

From an analysis of direct and indirect effects of 5307 corn in Chapter 4 on Socioeconomic issues, no 

cumulative effects of existing products with incorporation of the eCry3Ab are likely to the domestic 

economic environment, trade economic environment, and social environment.

Domestic Economic Environment. The actions potentially contributing to cumulative effects on 

the domestic economy are the introduction of transgenic corn varieties and their increasing use. 

Similar to currently available CRW corn products, farmers are expected to economically benefit from 

the introduction of 5307 corn. Combining insect resistance traits and herbicide tolerance traits in a 

single stacked product would likely convey the individual economic benefits of each trait to farmers 

and seed companies. The corn rootworm species are the most damaging corn pests, affecting as 

much as 32 million acres each year. Prior to the introduction of rootworm-protected GE corn 

varieties to the market, corn rootworms cost US farmers nearly $1 billion annually in crop losses and 

control costs (Rice, 2004). Using corn rootworm-protected varieties offsets these costs by increasing 

yield and reducing the risk, cost, and time associated with insecticide use (Rice, 2004). Seed 

companies and growers could also see an economic benefit, from increased profits. Similar benefits 

are expected from insect-resistant crops targeted at other economically significant pests. For 

example, lepidopteran-active Bt corn has remained effective against the European corn borer for 

more than a decade, yielding billions of dollars of estimated benefits to farmers in the Midwestern

US. The cumulative economic benefit to corn growers in a five-state region over a 14-year period 

ending in 2009 has been estimated at $6.9 billion (Hutchison et al., 2011). These growers include 

many who did not plant Bt corn varieties, but nevertheless benefited from area-wide suppression of 

European corn borer populations as a result of sustained Bt corn use in the region.

Herbicide-tolerant transgenic corn also has benefits for the domestic economy. For farmers, the 

general increase in yield, reduction in some input costs, improvement in pest control, increase in 

worker safety, and time-management benefits have generally outweighed the additional costs of 

transgenic seed (NRC, 2010). Herbicide-tolerant crops have not greatly increased yields but have 

generally improved weed control and improved farmers’ incomes by saving time.

The Preferred Alternative would positively affect, both directly and indirectly, the domestic 

economy. Growers would have a broader range of tools to use to control insect pests if 5307 corn is 

determined to have nonregulated status, directly reducing economic loss from economically 

important pests. A review of a similar stacked corn hybrid, SmartsStax, showed considerable 

monetary benefit to growers in the Corn Belt who plant this hybrid compared to previously selected 

products (Marra et al., 2010). Although the specific domestic economy benefits for Syngenta 5307 

cannot be calculated because of the variability and complexity of the market and unavailability of 

appropriate research, it is assumed that growers will make rational decisions to maximize economic 

gain from their operations, and 5307 corn stacked with other transgenic corn traits will increase the 

varieties available to growers and the flexibility.
90

6 Threatened and Endangered Species

6.1 The Endangered Species Act and APHIS Section 7 Process

Congress passed the Endangered Species Act (ESA) of 1973, as amended, to prevent extinctions 

facing many species of fish, wildlife, and plants. The purpose of the ESA is to conserve endangered 

and threatened species and the ecosystems on which they depend as key components of America‘s 

heritage. To implement the ESA, the U.S. Fish and Wildlife Service (USFWS) works in 

cooperation with the National Marine Fisheries Service (NMFS); other Federal, State, and local 

agencies; Tribes; non-governmental organizations; and private citizens. Before a plant or animal 

species can receive the protection provided by the ESA, it must first be added to the Federal list of 

threatened and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be endangered or

threatened because of any of the following factors: 

• The present or threatened destruction, modification, or curtailment of its habitat or range;

• Overutilization for commercial, recreational, scientific, or educational purposes; 

• Disease or predation; 

• The inadequacy of existing regulatory mechanisms; and 

• The natural or manmade factors affecting its survival. 

Once an animal or plant is added to the list, in accordance with the ESA, protective measures apply 

to the species and its habitat. These measures include protection from adverse effects of Federal 

activities.

Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or the 

NMFS, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the 

continued existence of a listed species or result in the destruction or adverse modification of 

designated critical habitat. It is the responsibility of the Federal agency taking the action to assess 

the effects of their action and to consult with the USFWS and NMFS if it is determined that the 

action ―may affect‖ listed species or critical habitat. To facilitate APHIS’ ESA consultation 

process, APHIS met with the USFWS from 1999 to 2003 to discuss factors relevant to APHIS‘s 

regulatory authority and effects analysis for petitions for nonregulated status, and developed a 

process for conducting an effects determination consistent with the Plant Protection Act (PPA) of 

2000 (Title IV of Public Law 106-224). This process is described in a decision tree document, 

which is presented in Appendix B. APHIS uses this process to help fulfill its obligations and 

responsibilities under Section 7 of the ESA for biotechnology regulatory actions.

APHIS‘ regulatory authority over GE organisms under the PPA is limited to those GE organisms 

for which it has reason to believe might be a plant pest or those for which APHIS does not have 

sufficient information to determine that the GE organism is unlikely to pose a plant pest risk (7 

CFR § 340.1). After completing a plant pest risk analysis, if APHIS determines that 5307 corn 

does not pose a plant pest risk, then 5307 corn would no longer be subject to the plant pest 

provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR Part 340, and 

therefore, APHIS must reach a determination that the article is no longer regulated. As part of its 

Environmental Assessment (EA) analysis, APHIS is analyzing the potential effects of 5307 corn on 
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the environment including any potential effects to threatened and endangered species and critical 

habitat. As part of this process, APHIS thoroughly reviews the genetically engineered product 

information and data related to the organism (generally a plant species, but may also be other 

genetically engineered organisms). For each transgene/transgenic plant, APHIS considers the 

following information and data:

• A review of the biology and taxonomy of the crop plant and its sexually compatible 

relatives;

• Characterization of each transgene with respect to its structure and function and the nature 

of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the 

plant and their quantity;

• A review of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact;

• Determination of the concentrations of known plant toxicants (if any are known in the 

plant); 

• Analysis to determine if the transgenic plant is sexually compatible with any threatened or 

endangered species (TES) of plants or a host of any TES; and

• Any other information that may inform the potential for an organism to pose a plant pest 

risk.

In following this review process, APHIS, as described below, has evaluated the potential effects 

that a determination of nonregulated status of 5307 corn plants may have, if any, on Federallylisted TES and species proposed for listing, as well as designated critical habitat and habitat 

proposed for designation. Based upon the scope of the EA and production areas identified in the 

Affected Environment section of the EA, APHIS obtained and reviewed the USFWS list of TES 

species (listed and proposed) for each state where corn is commercially produced from the USFWS 

Environmental Conservation Online System (ECOS; as accessed 1/27/2012 at 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp). Prior to this review, APHIS 

considered the potential for 5307 corn to extend the range of corn production and also the potential 

to extend agricultural production into new natural areas. As described further in the next section, 

there is no reason to believe that 5307 corn would be grown in areas outside of where corn in 

currently grown. Accordingly, the issues discussed herein focus on the potential environmental 

consequences of the determination of nonregulated status of 5307 corn on TES species in the areas 

where corn is currently commercially grown.

6.2 Potential Effects of 5307 Corn on TES

The analysis of potential effects considered the potential for 5307 corn to extend the range of corn 

production and the potential to expand agricultural production into new areas. Event 5307 corn does 

not express any phenotypic traits that would allow it to be commercially viable outside of the existing 

range of corn cultivation, and is targeted specifically for use in the regions where corn rootworm is a 

recognized agricultural pest (see Geographic Distribution of Northern and Western Corn Rootworm 

and their Variants, in Corn Rootworm Biology, Feeding Behavior and Economic Loss; Chapter 2, 

Section 2.2.2, Insect Management). As described in Section 4.2.2, Agronomic Practices, considering 

that 88 percent of the corn currently grown in the US is genetically modified, it is expected that 
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5307 corn, if determined to have nonregulated status, would be planted in areas where corn is 

currently grown. The agronomic analyses show that 5307 corn would use the same agronomic 

practices – including the same fertilizers, herbicides, fungicides, irrigation, crop rotations, and tillage 

– as non-transgenic corn hybrids. There is no hazard associated with the cultivation of 5307 corn that 

would be different from production of non-transgenic corn. 5307 corn like other varieties of corn

cannot naturalize (as discussed in Chapter 2, Section 2.1, Corn Biology) and has no potential to 

become weedy. Potential effects on habitat from 5307 corn are thus limited to those associated with 

typical commercial corn production, in areas where commercial corn has been historically produced. 

Therefore, production of 5307 corn would not affect the baseline condition of natural habitat, 

including designated critical habitat, of any listed species.

Corn, including 5307 corn, has no sexually compatible relatives found in natural areas, and is only

able to reproduce with other corn plants in the US (USDA-APHIS, 2011). Therefore, 5307 corn 

would not be sexually compatible with any listed threatened or endangered plant species or plant 

proposed for listing. Since there are no listed species that are sexually compatible with corn and 

production of 5307 corn would be limited to those areas already in corn production, no effect would 

be expected on listed plant species.

APHIS considered the possibility that 5307 corn could serve as a host plant for a threatened or 

endangered species. A review of the species list indicates that this would not occur. There are no 

members of the genus Zea that serve as a host plant for any threatened or endangered species.

The biosafety studies conducted by Syngenta (Syngenta, 2011c) show no toxic effects to birds, 

earthworms, fish, freshwater shrimp, non-target insects, or mammals, and show that the insecticidal 

effects of 5307 corn are limited to corn rootworm larvae, which are not pollinators. As described in 

the Petition, Syngenta evaluated the composition and nutritional quality of 5307 corn and compared 

its composition to the composition of a corresponding non-transgenic corn variety and other corn 

varieties for which composition data were available. The data suggest that there is no difference in 

composition and nutritional quality between 5307 corn and commercial corn varieties. Therefore,

5307 corn would have no effect on non-target animals that consume it, or on listed animal species, 

including animals such as insects (with the possible exception of those susceptible to the eCry3.1Ab

protein), bats or birds that may be pollinators of plants.

Apart from the transgene that encodes eCry3.1Ab in 5307 corn, 5307 corn also contains the gene pmi

(also known as manA) that encodes the selectable marker PMI enzyme, which is not a toxin and is 

exempt from both food and feed tolerances following an US-EPA analysis (US-EPA, 2004). 

Event 5307 corn does not express additional proteins, natural toxicants, allelochemicals, pheromones, 

or hormones, etc. that could directly or indirectly affect a listed species or species proposed for 

listing. Based on the compositional equivalency of 5307 corn to corn varieties currently in 

production (Syngenta, 2011c), the only potential stressor to TES species is that which could occur 

because of the inclusion of the eCry3.1Ab transgene (Syngenta, 2011c). 

A safety assessment(Syngenta, 2011c) conducted on 5307 corn showed that the insecticidal activity 

of eCry3.1Ab is limited to certain Chrysomelidae species within the order Coleoptera. The Cry 

proteins in general are highly specific toxins for limited taxa of insects and have no significant 

activity on other organisms in the environment ((US-EPA, 2001), updated 2011). Feeding assays 

have determined a No Observed Adverse Environmental Concentration for each of a collection of 

eleven indicator organisms that proved to be between 4.3 and 1200 times higher than the Estimated 
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Environmental Concentration to which these would likely be exposed (except for freshwater shrimp, 

for which higher NOAEC could not be practically provided because of difficulty providing higher 

Cry protein to the test organisms) (Syngenta, 2011c).The chrysomelids shown to be sensitive to the 

insecticidal effects of eCry3.1Ab are the larvae of the western corn rootworm (Diabrotica virgifera 

virgifera), northern corn rootworm (D. longicornis barberi), Mexican corn rootworm (D. virgifera 

zeae), and the Colorado potato beetle (Leptinotarsa decemlineata).

9 The eCry3.1Ab protein 

demonstrates no lepidopteran activity, despite containing sequences from a lepidopteran-active 

protein (Cry1Ab, as in MON 810; (Walters et al., 2010). The high specificity of the eCry3.1Ab

protein makes it unlikely that non-target or threatened or endangered insects would be affected.

The review of the species list identified insect species of the order Coleoptera that were further 

evaluated for the possibility of effects from exposure to 5307 corn. The consideration of protected 

species is limited to Coleoptera in corn growing regions, as this is the insect group to which corn 

rootworms belong, and the insecticidal protein produced in 5307 corn (eCry3.1Ab) has been shown 

to be active only on certain Coleoptera and not on other invertebrate or vertebrate species. Three 

Coleopteran specific Cry proteins currently expressed in commercial corn have been analyzed by 

US-EPA, and the agency concludes for one of these that Cry34Ab1/Cry35Ab1 will have “no 

adverse effect on endangered and threatened species listed by the US Fish and Wildlife Service is 

expected from the Event DAS-59122-7 corn registration (US-EPA, 2005) and also that “the Agency 

is aware of no identified significant adverse effects of Cry34/35Ab1 proteins on the abundance of 

non-target beneficial organisms in any population in the field, whether they are pest parasites, pest 

predators, or pollinators.” Analysis of effects on a susceptible Coleopteran, L. decemlineata, showed 

that the eCry3.1Ab protein did not act to synergize the effects of a second Cry protein, MIR604 (CBI, 

Syngenta, submitted to US-EPA), with which Syngenta proposes to pyramid into new commercial 

hybrids (Syngenta, 2011c). Lack of synergism in a susceptible species is evidence that no such 

interactions are likely to occur with nontarget species possibly exposed to this protein. The Preferred 

Alternative’s lack of potential impacts to the named species is also discussed in Section VIII D. and 

VIII E. of the Syngenta petition (Syngenta, 2011c).

Data on listed coleopteran species and critical habitat were obtained from the US Fish and Wildlife 

Service (http://www.fws.gov/species/). County-level species location information was obtained from 

a work product of the FIFRA Endangered Species Task Force (FESTF) including the Information 

Management System (IMS) and the NatureServe Multi-Jurisdictional Database (MJD) licensed by 

FESTF.10 This database contains county-level species data provided from the FWS and crop data 

from the USDA Census of Agriculture. This provides the best available aggregated data on federally 

listed species habitat and occurrence. Syngenta Crop Protection LLC is a full member of FESTF and 

has access to this licensed dataset. This database provides information only for extant species 

locations.

A total of 18 coleopteran species listed by the FWS were identified as Endangered or Threatened 

under the ESA (ECOS; as accessed 1/27/2012 at 

http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp)., three of which do not occur in 

counties of corn-growing regions (see Figure 1). At present, there are no additional coleopteran 

species proposed for listing (ECOS; as accessed 1/27/2012 at 

http://ecos.fws.gov/tess_public/SpeciesReport.do?listingType=P). Table 11 lists the 15 threatened or 

 9 The Colorado potato beetle is not a pest of corn, but it is sensitive to eCry3.1Ab in direct laboratory feeding studies. 10 See the FESTF website at http://www.festf.org/visitors/default.asp.
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endangered species of Coleoptera found within corn-growing regions. Critical habitat, where 

established by the FWS, is also indicated.

Table 11: Threatened or Endangered Coleopteran Species Occurring in Corn Growing 

Regions

Scientific Name Family Common Name ESA Status Critical Habitat

Batrisodes texansus Staphylinidae Coffin Cave mold beetle Endangered None

Batrisodes venyivi Staphylinidae Helotes mold beetle Endangered Bexar Co., TX

Brychius hungerfordii Halipidae Hungerford’s crawling water beetle Endangered None

Cicindela dorsalis dorsalis Carabidae Northeastern beach tiger beetle Threatened None

Cicindela nevadica lincolniana Carabidae Salt Creek tiger beetle Endangered Lancaster and Saunders Co., NE

Cicindela puritan Carabidae Puritan tiger beetle Threatened None

Desmocerus californicus 

dimorphus

CerambycidaeValley elderberry longhorn beetle Threatened Sacramento Co., CA

Elaphus viridus Carabidae Delta green ground beetle Threatened Solano Co., CA

Heterelmis comalensis Byrrhoidae Comal Springs riffle beetle Endangered Hays and Comal Co., TX

Nicrophorus americanus Silphidae American burying beetle Endangered None

Rhadine exilis Carabidae None Endangered Bexar Co., TX

Rhadine infernalis Carabidae None Endangered Bexar Co., TX

Rhadine persephone Carabidae Tooth Cave ground beetle Endangered None

Stygoparnus comalensis Dryopidae Comal Springs dryopid beetle Endangered Hays and Comal Co., TX

Texamaurops reddelli Staphylinidae Kretschmarr Cave mold beetle Endangered None

Source: FIFRA Endangered Species Task Force (FESTF)

Refined geospatial analysis showed that only three of the 15 coleopteran species co-occur with 

potential corn production locations:

• Kretschmarr Cave mold beetle (Texamaurops reddelli),

• American burying beetle (Nicrophorus americanus), and

• Salt Creek tiger beetle (Cicindela nevadica lincolniana).

The analysis showed that there would be no exposure of two of these species to 5307 corn. The 

Kretschmarr Cave mold beetle inhabits small isolated caves within the Edwards Limestone 

formation in Texas (USFWS, 1988), making contact with corn unlikely. The American burying 

beetle relies on carrion (mammals, birds, reptiles) as a food source (US-FWS, 2011) and would not 

be expected to ingest 5307 corn or its insecticidal protein because it does not eat corn or insects. The 

Salt Creek tiger beetle is a predatory beetle that feeds on other insects, and due to its observed 

proximity to corn production areas it may conceivably be exposed to very low eCry3.1Ab 

concentrations (compared to levels measured in 5307 corn) via predation. While predation upon 

arthropods containing trace amounts of eCry3.1Ab is possible, the beetle’s predation habits would 

greatly limit the opportunity for such exposure. Salt Creek tiger beetle larvae are known to prey on 

insects from the entrance of permanent burrows built in saline stream banks and barren salt flats of 

saline wetlands - habitats which do not occur in cornfields (USFWS, 2005). Critical habitat for this 

beetle includes pasture land that is unlikely to be used for corn production because it is mostly saline 

marsh (US-FWS, 2010), and 5307 corn has no characteristics to make it more likely to be planted on 

this habitat than any other variety. Therefore, any exposure of Salt Creek tiger beetles to even trace 
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amounts of eCry3.1Ab via their prey would be unlikely. Further, if such exposure were to occur, no 

measurable hazard is predicted. The Salt Creek tiger beetle is a member of the Carabidae family. 

Biosafety analyses documented in the Petition (Syngenta, 2011c) showed no effects of eCry3.1Ab on 

the survival of carabid beetles when tested at levels 62 times greater than the worst-case estimated 

environmental concentration.11

After reviewing the potential effects of 5307 corn on the environment that could result from a 

determination of nonregulated status of 5307 corn, APHIS has not identified any stressor that could 

affect the reproduction, numbers, or distribution of a listed threatened or endangered species or 

species proposed for listing. APHIS considered the effect of 5307 corn production on designated 

critical habitat or habitat proposed for designation and could identify no difference from effects 

that would occur from the production of other corn varieties. Corn is not considered a particularly 

competitive plant species and is ecologically limited to production by human populations. Corn is 

not considered weedy and feral populations of corn have not been identified in the U.S. 5307 corn 

is not sexually compatible with, or serves as a host species for, any listed species or species 

proposed for listing. Consumption of 5307 corn by any listed species or species proposed for 

listing will be either unlikely or will not result in a toxic or allergic reaction. Based on these 

factors, APHIS has determined that 5307 corn would have no effect on listed threatened or 

endangered plant or animal species or such species proposed for listing and would not affect listed 

threatened or endangered plant or animal species’ designated critical habitat or habitat proposed for 

designation. Because of this no effect determination, consultation under Section 7(a)(2) of the Act 

or the concurrence of the USFWS or NMFS is not required.

 11 The worst-case estimate assumes that the organisms’ diet is comprised of 100 percent 5307 corn material.
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7 CONSIDERATION OF EXECUTIVE ORDERS AND OTHER FEDERAL LAWS 

RELATING TO ENVIRONMENTAL IMPACTS

As required by the CEQ, this Chapter considers the Executive Orders (EOs) and other federal laws 

related to the potential environmental impacts of the Preferred Alternative.

7.1 Executive Orders with Domestic Implications

Four EOs have domestic implications that are relevant to the environmental assessment of the 

petition to deregulate 5307 corn.

7.1.1 Executive Order 12898: Environmental Justice

EO 12898, Federal Actions to Address Environmental Justice in Minority Populations and 

Low-Income Populations (EO 12898 of February 11, 1994), requires federal agencies to conduct 

their programs, policies, and activities that substantially affect human health or the environment in a 

manner so as not to exclude persons and populations from participation in or benefiting from such 

programs. It also enforces existing statutes to prevent minority or low-income communities from 

being subjected to disproportionately high and adverse human health or environmental effects.

Each alternative was analyzed with respect to EO 12898. Neither alternative is expected to have a 

disproportionate adverse effect on minorities or low-income populations. As presented in the 

Environmental Consequences section, no significant impacts were identified in the analyses 

conducted on human health, physical environment, or animal and plant communities.

Event 5307 corn is not significantly different from other transgenic or non-transgenic corn. As 

described in Chapter 4, Section 4.4.1, Animals, the eCry3.1Ab and PMI proteins do not pose a hazard 

to humans. A voluntary FDA consultation for food and feed use of 5307 corn was initiated in 

January 2011 (Appendix B, (Syngenta, 2011a). Data and information provided by Syngenta support 

the safe use of 5307 corn and indicate that it will be as nutritious and wholesome as other corn 

current used as food and feed (Syngenta, 2011c). Based on this information, 5307 corn is not 

expected to have a disproportionate adverse effect on minorities or low-income populations.

As described in Chapter 4, Section 4.2.2, Agronomic Practices, the cultivation of corn varieties

with similar insect resistance traits have been associated with a decrease in the volume of 

insecticides being applied. If insecticide applications are reduced, there may be a beneficial effect 

on minority populations. These populations might include farm workers and their families, and 

other rural dwelling individuals who are potentially exposed to insecticides through aerial 

application, groundwater, or other routes of exposure.

7.1.2 Executive Order 13045: Protection of Children

EO 13045, Protection of Children from Environmental Health Risks and Safety Risks (EO 13045 of 

April 21, 1997), acknowledges that children may suffer disproportionately from environmental health 

and safety risks because of their developmental stage, greater metabolic activity levels, and behavior 

patterns, as compared to adults. This EO requires each federal agency (to the extent permitted by law 

and consistent with the agency’s mission) to identify, assess, and address environmental health risks 

and safety risks that may disproportionately affect children.
97

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.

Event 5307 corn is not significantly different from other transgenic or non-transgenic corn. As 

described in Chapter 4, Section 4.4.1, Animals, the eCry3.1Ab and PMI proteins do not pose a hazard 

to humans. A voluntary FDA consultation for food and feed use of 5307 corn was initiated in 

January, 2011 (Appendix B (Syngenta, 2011a). Data and information provided by Syngenta support 

the safe use of 5307 corn and indicate that it will be as nutritious and wholesome as other corn 

current used as food and feed (Syngenta, 2011a) ; (Syngenta, 2011c). Based on these analyses, 5307 

corn is not expected to have a disproportionate adverse effect on children.

As described in Chapter 4, Section 4.2.2, Agronomic Practices, the cultivation of corn varieties with 

similar insect resistance traits have been associated with a decrease in the volume of insecticides 

being used. If insecticide applications are reduced, there may be a beneficial effect on children that 

might be exposed to the chemicals. Similar to minority populations, these children might include 

families of farm workers and other rural dwelling individuals who are exposed to insecticides 

through aerial application, groundwater contamination, or other routes.

7.1.3 Executive Order 13112: Invasive Species

EO 13112, Invasive Species (EO 13112 of February 3, 1999), requires federal agencies to take action 

to prevent the introduction of invasive species, to provide for their control, and to minimize the 

economic, ecological, and human health impacts that invasive species cause.

All corn varieties, including 5307 corn, require human assistance to persist beyond a first generation 

of corn plants that may arise from spilled seed; they do not establish self-propagating populations. 

Corn does not possess traits that are characteristic of invasive species (Baker, 1965) ; (Keeler, 1989), 

; (Galinat, 1988). As described in Section 4.4.5, Gene Movement in the Natural Environment, 

5307 corn plants are very similar in agronomic characteristics to other corn varieties that are currently 

grown and are not expected to become weedy or invasive. Accordingly, the Preferred Alternative

would not raise concerns addressed by EO 13112, Invasive Species.

7.1.4 Executive Order 13186: Migratory Birds

EO 13186, Responsibilities of Federal Agencies to Protect Migratory Birds (Federal Register 

66:3853, January 10, 2001), requires each federal agency to avoid and minimize, to the extent 

practicable, adverse impacts on migratory bird populations when conducting agency actions.

Although migratory birds forage in corn fields, as described in Section 4.4.1, Animals, 5307 corn is 

not expected to have any adverse impacts on migratory birds because the eCry3.1Ab protein is not 

biologically active in avian species. To confirm the absence of any impact on avian species, Syngenta 

has conducted an eCry3.1Ab toxicity study on juvenile bobwhite quail and a 5307 corn feeding study 

on broiler chickens, in which no harmful effects to quail or chickens were observed (Syngenta, 

2011c). A determination of non-regulated status of 5307 corn therefore is not expected to have a 

negative effect on migratory bird populations. 
98

7.2 Executive Orders with International Implications

EO 12114, Environmental Effects Abroad of Major Federal Actions (Federal Register 44:1957,

January 4, 1979), requires federal officials to take into consideration any potential environmental 

effects outside the US, its territories, and possessions that may result from actions being taken.

All of the existing national and international regulatory authorities and phytosanitary regimes that 

currently apply to introduction of new corn cultivars internationally apply equally to those covered by 

an APHIS determination of non-regulated status under 7 CFR Part 340. International trade of 

5307 corn subsequent to a determination of non-regulated status for the product would be fully 

subject to national phytosanitary requirements and be in accordance with phytosanitary standards 

developed under the International Plant Protection Convention (IPPC, 1997).

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, 1997). The protection it affords extends to natural flora and plant products and 

includes both direct and indirect damage by pests, including weeds. The IPPC set a standard for the 

reciprocal acceptance of phytosanitary certification among the 177 nations that have signed or 

acceded to the convention (IPPC, 2011). In April 2004, a standard for pest risk analysis (PRA) of 

living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a 

supplement to the existing International Standard for Phytosanitary Measure No. 11 (IPPC, 2004). 

The standard acknowledges that LMOs will not present a pest risk and that a determination needs to

be made early in the PRA for importation as to whether the LMO poses a potential pest risk resulting 

from the genetic modification. APHIS pest risk assessment procedures for genetically engineered 

organisms are consistent with the guidance developed under the IPPC. In addition, issues that may 

relate to commercialization and transboundary movement of particular agricultural commodities 

produced through biotechnology are being addressed in other international forums and through 

national regulations.

The Cartagena Protocol on Biosafety (the Protocol) is a treaty under the United Nations Convention 

on Biological Diversity (CBD) that established a framework for the safe transboundary movement, 

with respect to the environment and biodiversity, of LMOs, which includes those modified through 

biotechnology. The Protocol came into force on September 11, 2003, and 161 countries are currently 

parties to it (CBD, 2011). Although the US is not a party to the CBD and thus not a party to the 

Protocol, US exporters will still need to comply with domestic regulations that importing countries 

that are parties to the Protocol have put in place to comply with their obligations.

The first intentional transboundary movement of LMOs intended for environmental release (field 

trials or commercial planting) will require consent from the importing country under an advanced 

informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent 

with Annex III of the Protocol, and the required documentation. LMOs imported for food, feed, or 

processing (FFP) are exempt from the AIA procedure, and are covered under Article 11 and Annex II 

of the Protocol. Under Article 11, parties must post decisions to the Biosafety Clearinghouse 

database on domestic use of LMOs for FFP that may be subject to transboundary movement. To 

facilitate compliance with obligations to this protocol, the US government has developed a website 

that provides the status of all regulatory reviews completed for different uses of bioengineered 

products (http://usbiotechreg.nbii.gov). These data will be available to the Biosafety Clearinghouse. 

International trade of 5307 corn would be conducted in compliance with the Protocol.
99

Biosafety and biotechnology consensus documents, guidelines, and regulations, are managed by 

APHIS in accordance with the requirements of the North American Plant Protection Organization 

(NAPPO) and the Organization for Economic Cooperation and Development (OECD). NAPPO has 

completed three modules of the Regional Standards for Phytosanitary Measures (RSPM) No. 14, 

Importation and Release (into the environment) of Transgenic Plants in NAPPO Member Countries

(NAPPO, 2003). The Preferred Alternative is not expected to affect APHIS’s participation in 

NAPPO or the OECD.

North American Biotechnology Initiative is a forum for information exchange and cooperation on 

agricultural biotechnology issues for the US, Mexico, and Canada. Bilateral discussions on 

biotechnology regulatory issues are also held regularly with other countries including Argentina, 

Brazil, Japan, China, and South Korea. Several countries, including Argentina, Brazil Australia, 

Canada, China, Columbia, Japan, Mexico, New Zealand South Korea, the Philippines, South Africa, 

and the European Union, have already approved Bt corn varieties to be grown or imported for food or 

feed (CERA, 2010).

As described in Section 4.6.2, Trade Economic Environment, the Preferred Alternative is not 

expected to affect the US corn export market since Syngenta is actively pursuing regulatory 

approvals for 5307 corn in countries with functioning regulatory systems for genetically modified 

organisms and that import corn from the US or Canada. Regulatory filings for 5307 corn import 

approvals have been made in Australia, Japan, New Zealand, South Africa, South Korea, Taiwan, 

and the European Union Syngenta, (Syngenta, 2011c). Applications are planned for additional 

countries including Mexico, China, the Philippines, Indonesia, and Russia (Syngenta, 2011c).

7.3 Other Federal Laws

7.3.1 Clean Water Act

The Federal Water Pollution Control Act (commonly referred to as the Clean Water Act) (Federal 

Water Pollution Control Act, as amended, 33 USC 1251-1376) and implementing regulations 

(USACOE, various dates; 33 CFR Parts 320 through 332; US-EPA, various dates; 40 CFR Parts 230 

through 233) require entities that discharge regulated materials to certain surface water bodies 

(including wetlands) obtain authorization to do so from federal or state agencies under various permit 

programs.

Cultivation of 5307 corn is not expected to lead to the increased production of corn in U.S. 

agriculture. As described in Section 4.3.1, Water Quality and Use, water quality is not likely to 

change as a direct or indirect result of the Preferred Alternative. A determination of nonregulated 

status of 5307 corn would not result in a change of agricultural practices or any new discharge of 

pollutants to surface water bodies. Water quality would continue to be regulated and agronomic 

practices to protect water quality would continue to be implemented in the event of a determination 

of nonregulated status of 5307 corn. Chemical insecticide use would continue to be reduced as 

transgenic corn products with insect-resistant traits are developed, marketed, and adopted. Cultivating 

5307 corn would not require Clean Water Act permits different than those already required for 

agricultural activities.
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7.3.2 Clean Air Act

The Clean Air Act Amendments of 1990 (commonly abbreviated as the Clean Air Act; as amended,

40 USC 7401-7671) and implementing regulations (US-EPA, various dates; 40 CFR Parts 50 

through 99) require entities that discharge regulated materials into the atmosphere obtain 

authorization to do so from federal or state agencies under various permit programs.

Cultivation of 5307 corn is not expected to lead to the increased production of corn in U.S. 

agriculture. As described in Section 4.3.3, Air Quality, the Preferred Alternative is not likely to 

directly change air quality. Event 5307 corn production would not change land acreage or cultivation 

practices for transgenic or non-transgenic corn. Air quality would be indirectly improved if aerial 

application of corn rootworm pesticides is reduced. Corn growers would continue current trends in 

agricultural activities in the event of a determination of nonregulated status of 5307 corn. Spray 

application of insecticides could continue to be reduced as additional insect-resistant products are 

adopted by growers because 5307 corn would give growers another option to combat corn rootworm. 

Cultivating 5307 corn would not require Clean Air Act permits different than those already required 

for agricultural activities.

7.3.3 National Historic Preservation Act

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) 

determine whether activities they propose constitute "undertakings" that have the potential to cause 

effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such historic 

resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic 

Preservation Office, Tribal Historic Preservation Officers), as appropriate. 

APHIS’ proposed action, a determination of nonregulated status of 5307 corn is not expected to

adversely impact cultural resources on tribal properties. Any farming activity that may be taken by 

farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would have 

control over any potential conflict with cultural resources on tribal properties. 

A determination of nonregulated status of 5307 corn would have no impact on districts, sites, 

highways, structures, or objects listed in or eligible for listing in the National Register of Historic 

Places, nor would it likely cause any loss or destruction of significant scientific, cultural, or historical 

resources. This action is limited to a determination of nonregulated status of 5307 corn. Standard 

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

on these agricultural lands including the use of US-EPA registered pesticides. Applicant’s adherence 

to US-EPA label use restrictions for all pesticides will mitigate impacts to the human environment. 

A determination of nonregulated status of 5307 corn is not an undertaking that may directly or 

indirectly cause alteration in the character or use of historic properties protected under the National 

Historic Preservation Act. In general, common agricultural activities conducted under this action do 

not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are 

used that could result in effects on the character or use of historic properties. For example, there is 

potential for audible effects on the use and enjoyment of a historic property when common 

agricultural practices, such as the operation of tractors and other mechanical equipment, are 

conducted close to such sites. A built-in mitigating factor for this issue is that virtually all of the 

methods involved would only have temporary effects on the audible nature of a site and can be ended 

at any time to restore the audible qualities of such sites to their original condition with no further 

adverse effects. Additionally, these cultivation practices are already being conducted throughout the 
101

corn production regions. The cultivation of 5307 corn does not inherently change any of these 

agronomic practices so as to give rise to an impact under the NHPA.

7.3.4 Federal Laws Regarding Unique Characteristics of Geographic Areas

There are no unique characteristics of geographic areas such as park lands, prime farm lands, 

wetlands, wild and scenic areas, or ecologically critical areas that would be adversely impacted by a 

determination of nonregulated status of 5307 corn.

 

The common agricultural practices that would be carried out under the proposed action will not cause 

major ground disturbance; do not cause any physical destruction or damage to property; do not cause 

any alterations of property, wildlife habitat, or landscapes; and do not involve the sale, lease, or 

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

status of 5307 corn. The product will be deployed on agricultural land currently suitable for 

production of corn, will replace existing varieties, and is not expected to increase the acreage of corn 

production. This action would not convert land use to nonagricultural use and therefore would have 

no adverse impact on prime farm land. Standard agricultural practices for land preparation, planting, 

irrigation, and harvesting of plants would be used on agricultural lands planted to 5307 corn 

including the use of US-EPA registered pesticides. Applicant’s adherence to US-EPA label use 

restrictions for all pesticides will mitigate potential impacts to the human environment. In the event 

of a determination of nonregulated status of 5307 corn, the action is not likely to affect historic or 

cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically 

critical areas that may be in close proximity to corn production sites.

7.4 Regulations, Policies, and Executive Orders

Clean Air Act Amendments of 1990, as amended. Codified at 40 USC § 7401-7671.

Energy Policy Act of 2005. Public Law 109-58. August 8, 2005. Codified at 42 USC § 15801 et seq.

Endangered Species Act of 1973, as amended. Public Law 93-205. Codified at 7 USC § 126 and 

16 USC § 1531 et seq.

Executive Office of the President, Office of Science and Technology Policy. 1986. Coordinated 

Framework for Regulation of Biotechnology. Published in the Federal Register (FR) at 51 FR 23302 

on June 26, 1986.

Executive Order 12114 of January 4, 1979. Environmental Effects Abroad of Major Federal Actions. 

Published at 44 FR 1957 on January 4, 1979.

Executive Order 12898 of February 11, 1994. Federal Actions to Address Environmental Justice in 

Minority Populations and Low-Income Populations. Published at 59 FR 7629 on February 11, 1994.

Executive Order 13045 of April 21, 1987. Protection of Children from Environmental Health Risks 

and Safety Risks. Published at 62 FR 19883 on April 21, 1987.

Executive Order 13112 of February 3, 1999. Invasive Species. Published at 64 FR 6183 on February 

3, 1999.
102

Executive Order 13186 of January 10, 2001. Responsibilities of Federal Agencies to Protect 

Migratory Birds. Published at 66 FR 3853 on January 10, 2001.

Executive Order 13563 of January 18, 2011. Improving Regulation and Regulatory Review. 

Published at 76 FR 14 on January 21, 2011.

Federal Food, Drug, and Cosmetic Act, as amended. 1938. Public Law 75-717. Codified at 21 USC 

§ 301 et seq.

Federal Insecticide, Fungicide, and Rodenticide Act, as amended. 1940. Public Law 80-104. 

Codified at 7 USC § 136 et seq.

Federal Water Pollution Control Act (Clean Water Act). 1948. Public Law. 845. Codified at 33 USC 

§ 1251 et seq.

Food, Conservation, and Energy Act of 2008. Public Law 110-234. May 22, 2008. Codified at 7 USC

§ 8711 et seq., and § 8751 et seq.

National Environmental Policy Act, as amended. 1970. Public Law 91-190. Codified at 

42 USC § 4321 et seq.

National Historic Preservation Act of 1966, as amended. Public Law 89-665. October 15, 1966. 

Codified at 16 USC § 470 et seq.

Plant Protection Act. 2000. Title IV of the Agriculture Risk Protection Act of 2000. Public Law 106-

224. Codified at 7 USC § 7701 et seq.

Toxic Substances Control Act, as amended. 1976. Public Law 94-469. Codified at 15 USC § 2601 

et seq.

United States Army Corps of Engineers (USACOE). Various dates. 33 CFR Parts 320 through 332.

United States Department of Agriculture (USDA). 1990. Policy of Noxious Weed Management. 

Departmental Regulation Number 9500-10. Washington, DC: USDA.

USDA-Agricultural Marketing Service (USDA-AMS). 2007. The National List of Allowed and 

Prohibited Substances. 7 CFR Part 205.600 et seq.

USDA-APHIS. 1987. Introduction of Organisms and Products Altered or Produced Through Genetic 

Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests. 7 CFR Part 

340.

USDA-APHIS. 1995. National Environmental Policy Act Implementing Procedures. 7 CFR Part 372.

United States Department of Health & Human Services - Food and Drug Administration (USDHHSFDA). 1992. Statement of Policy: Foods Derived From New Plant Varieties. 57 FR 22984, May 29, 

1992.
103

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9 LIST OF PREPARERS

USDA APHIS Biotechnology Regulatory Service

1. David Reinhold, Associate Director, Environmental Risk Assessment Program

2. Craig Roseland, Senior Environmental Risk Assessment Specialist

3. Khamkeo Vongpaseuth, Environmental Risk Assessment Specialist
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Appendix A Supplemental Information on Insecticide Use with Traits in Corn

An article written by Lynn Grooms for Farm Industry News describes how some corn growers are

now using soil insecticides with traits.

1 This article nicely summarizes the circumstances under

which it could be advantageous for a grower to apply conventional insecticide when rootwormprotected Bt corn varieties have been planted. Root feeding damage by corn rootworms 

(Diabrotica spp.) has always been costly for U.S. growers. Before introduction of the first 

rootworm-protected Bt hybrids growers had two options for limiting damage caused by these pests: 

crop rotation and application of conventional insecticides. Rotation gradually lost its effectiveness 

in certain regions of the Midwest with the spread of a western corn rootworm variant that had 

developed an affinity for laying eggs in soybean fields and an extended diapause northern corn

rootworm variant that could survive the rotation. Insecticide applications have historically not 

been made on the majority of planted acres (Figure 1) because the low price of corn (Figure 2) did 

not always justify the expense and most growers did not have the equipment necessary for their

application. Furthermore, environmental factors often limited the effectiveness of insecticide 

applications.

100

90

80

70

60

50

40

30

20

10

0

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

 Soil-applied Insecticide Acres Planted

Figure 1. Total acres of corn planted annually in the continental U.S. and acres of corn treated annually with a

soil-applied conventional insecticide (excluding seed treatments). GfK Kynetec Market Research, database

query (2011).

The first genetically engineered corn varieties offering protection from rootworm feeding 

damage entered the market in 2003. Today there are many varieties available to growers 

containing one or more of the following events determined to have nonregulated status that are

active against corn rootworms: MON 88017, DAS-59122-7, and MIR604. These hybrids 

have been rapidly adopted by growers because they provide better protection from root 

feeding damage and are

1 CRW Combos. February 1, 2009. http://farmindustrynews.com/corn-rootworm-traits/crw-combos
124

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more convenient to use than conventional insecticides; 52% of corn acres in 2011 were planted 

with hybrids containing these traits (Figures 2 and 3). As trait acreage has increased, acres 

treated with conventional insecticides have decreased (Figure 3). Only 6.8 million corn acres 

were treated with a soil-applied insecticide in 2011, a 72% reduction from acres treated in 2003. 

This trend validates assumptions made ten years ago by U.S. regulatory agencies that introduction 

of corn rootworm protection traits had the potential to significantly reduce insecticide use.

100

90

80

70

60

50

40

30

20

10

0

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

7.00

6.00

5.00

4.00

3.00

2.00

1.00

0.00

Acres Planted Price

Figure 2. U.S. corn acres planted annually and average price of corn received ($/bu). USDA National 

Agricultural Statistics Service Charts and Maps 2011 

(http://www.nass.usda.gov/Charts_and_Maps/index.asp)

50

40

30

20

10

0

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Soil-applied Insecticide CRW Trait

Figure 3. U.S. corn acres planted with a corn rootworm-protected trait hybrid and acres treated with a soilapplied insecticide (aerial, banded, banded before press wheel, banded behind press wheel, banded in- furrow

and broadcast applications). GfK Kynetec Market Research, database query (2011).
125

The introduction of corn varieties that were genetically engineered to resist Diabrotica feeding 

damage provided growers with a powerful and environmentally friendly new tool for protecting 

their corn crops. However, the Bt trait technology does not provide 100% root protection under all 

environmental circumstances. Unlike the Bt toxins that are active against lepidopteran species, the

toxins produced in rootworm-protected varieties currently on the market are not high dose. When 

high corn rootworm larval populations are present (i.e., high pressure) significant

root feeding damage can occur in traited varieties.

2 Such has recently been reported by university

extension services.

3,4 Certain regions of the corn belt are at greater risk of having high

rootworm larval pressure (Figure 4). This region spans eastern Colorado through Nebraska,

Iowa, and northern Illinois. Higher populations of the rotation-resistant rootworm variants have 

been reported in this area. Much continuous corn is planted in this area because it contains a 

relatively high density of ethanol mills and livestock feeding yards.

Figure 4. General region of the US corn belt at greater risk of high corn rootworm larval populations (red 

shaded area). Source: Syngenta Market Research.

Field trials conducted by University of Illinois researchers in 2008 demonstrated that under high

rootworm pressure substantial root feeding damage can occur in traited plants.

5 Under such

conditions additional root protection can be obtained when traited corn is deployed in 

combination with a conventional insecticide. Figure 5 presents results for 2008 corn rootworm

2 A root damage rating for unprotected plants exceeding 2.0 on the NIS is generally regarded as reflecting “high 

rootworm pressure”. 3 University of Illinois Extension. The Bulletin. Pest Management and Crop Development Information for Illinois

(http://bulletin.ipm.illinois.edu/). Issue No. 23 Article 3 (2008); Issue No. 24 Article 4 (2009); Issue No. 23 Article

2 (2010). 4 University of Illinois Extension (2011). On Target. Annual review of University of Illinois insect management 

trials (http://ipm.illinois.edu/ontarget/2011report.pdf) 5 Oleson, J.D., Y. Park, T.M. Nowatzki, and J.J. Tollefson (2005). Node-injury scale to evaluate root injury by corn

rootworms (Coleoptera: Chrysomelidae). J. Econ. Entomol. 98:1-8.
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Mean

NIS

Ratin

g

(0 3)

damage trials conducted at two locations in Illinois. The entire data set from these trials is 

available online;

6 only selected results from the DeKalb and Perry locations are presented here. 

The purpose of these trials was to compare the effectiveness of multiple corn rootworm control 

technologies available to growers. The following entries were replicated in a randomized 

complete block design and rated at both locations:

• Soil-applied Force∨ CS (tefluthrin insecticide) on hybrid 34P89

• YieldGard VT (event MON 88017) in hybrid DKC 63-42

• Soil-applied Force CS on YieldGard VT in hybrid DKC 63-42

• Hybrid DKC 63-46 (untreated isoline)

• Herculex Xtra (event DAS-59122-7) in hybrid 34P94

• Soil-applied Force CS on Herculex Xtra in hybrid 34P94

• Hybrid 34P89 (untreated isoline)

3

2.5

2

1.5

1

0.5

Force CS (34P89) 

YieldGard VT (DKC 63-42)

Force CS + YieldGard VT (DKC

63-42)

DKC 63-46 (untreated) 

HxXtra (34P94)

Force CS + HxXtra (34P94)

0

DeKalb Perry

Location

34P89 (untreated)

Figure 5. Selected root damage ratings from University of Illinois product efficacy trials conducted at DeKalb and

Perry, Illinois during the 2008 corn growing season. Root feeding damage was rated according to the Iowa State

University node-injury scale (NIS). Mean ratings from four replicated plots are presented. Force CS was applied

at 0.46 oz/ac in a 5-inch band over the planted row.

Heavy corn rootworm larval pressure was present in the 2008 trial conducted at DeKalb as 

evidenced by the mean NIS ratings >2.0 for the two unprotected isoline entries. Conventional 

insecticide used alone or a rootworm protection trait used alone offered significant protection 

from root feeding damage but not complete protection. Under this high rootworm pressure the

6 Steffey, K. (2008). The Bulletin. Pest Management and Crop Development Information for Illinois

(http://bulletin.ipm.illinois.edu/). Issue No. 23 Article 3 (October 3, 2008). ∨ Registered trademark of Syngenta
127

mean NIS ratings at DeKalb for Force CS, YieldGard VT, and Herculex Xtra entries were 

similar and close to 1.0. When either trait was deployed with the conventional insecticide, root 

feeding damage was minimal; mean NIS ratings fell to 0.05-0.18. When rootworm pressure is 

high, growers would likely benefit from deploying traited corn in combination with a 

conventional insecticide.

In contrast, rootworm pressure at the Perry location was not very high; mean NIS ratings were

<1.0 in the unprotected isoline entries. Under these conditions the traits provided nearly 

complete protection from root feeding damage. The incremental reduction in NIS rating obtained 

by deploying trait in combination with an insecticide was inconsequential. Thus, there would be

no economic incentive for a grower to invest in a chemical application.

In addition to Diabrotica spp., there are other soil dwelling insects that feed on corn roots, for 

example, Japanese beetle larvae, cutworms, and wireworms. These insects are not controlled by 

the rootworm-active Bt toxins in traited varieties. Historically, damage caused by these pests was 

considered minor compared to that caused by corn rootworms. However, when the price of

corn exceeds $6/bu, controlling these secondary pests may be economically worthwhile for some

growers.

Changing market conditions have led some growers to consider use of a conventional insecticide 

in combination with planting a rootworm-protected variety. Increasing global demand for 

livestock feed and domestic ethanol production has acted to drive corn prices to record high levels, 

currently in excess of $6/bu. Between 2001 and 2010 the average cost of an insecticide soil 

application in corn ranged from $11.24/ac to $12.70/ac. If applying a soil insecticide to a traited

acre produces a yield benefit of ε3 bushels it would be economically worthwhile for a grower to 

make such an application. This assumes the grower has the equipment to apply the insecticide and 

can anticipate conditions where such a yield benefit would be obtained. Results of 96 on-farm 

comparison trials conducted by growers in 2011 indicate that yield benefits can often be obtained 

when traited corn is deployed with the soil-applied insecticide Force CS or Force 3G (see Figure

6). These trials were conducted in locations that are typically under high rootworm pressure: 

northern Illinois, northern Indiana, and eastern Iowa. The average yield difference between

insecticide-treated and nontreated fields was 10.9 bu/ac with the yield gain attributable to 

insecticide treatment. This represents a potential $65/ac gain for growers.

As described in the petition for deregulation, Syngenta will commercialize Event 5307 corn in a 

breeding combination with its corn rootworm-protected corn trait, MIR604 previously determined 

to have nonregulated status. This combination will offer two benefits: 1) enhanced protection 

from rootworm feeding damage in a breeding stack configuration, and 2) reduction in insect 

resistance risk when roots contain multiple toxins active against rootworm larvae. The results of

Syngenta trait performance trials conducted between 2005 and 2009 demonstrate that enhanced 

protection from rootworm feeding damage is obtained when Event 5307 is introgressed into 

established corn lines containing Event MIR604. The results of trials conducted at 21 locations 

throughout the Corn Belt are summarized in Figure 7.
128

Mean

NIS

R i

Figure 6. Results of 96 grower comparison trials conducted during 2011. In a split field design growers 

compared yield from insecticide treated and non-treated fields. Whole fields were planted with a single corn 

rootworm traited hybrid (YieldGard VT, Herculex Xtra, or Agrisure RW). Half the field received a soil application of

Force insecticide, either the CS or 3G formulation, and the other half of the field was not treated with insecticide.

Fields were managed according to local practices. Each half of the field was harvested separately and yield was

measured. The chart presents the difference in yield for each split field trial: [yield with insecticide – yield without

insecticide = yield difference].

3

2.5

2

1.5

1

0.5

0

 Isoline check MIR604 MIR604x5307

Figure 7. Summary root damage ratings from Syngenta trait performance trials conducted at 21 locations 

between 2005 and 2009 in the U.S. corn belt. [NIS – Syngenta modified scale for 4” root pruning]

Some growers are applying conventional insecticides to fields planted with transgenic corn 

varieties containing a rootworm protection trait. A multitude of factors influence this grower 

decision, including the high price of corn, planting in areas with high rootworm larval populations, 

limitations on trait performance for currently available varieties, and the presence of
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secondary soil insect pests. A decision to deregulate Event 5307 corn would provide no 

additional incentive for growers to apply conventional insecticide to traited acres. Quite the 

contrary would be true. Deregulating 5307 corn would provide for enhanced rootworm 

protection of Syngenta’s currently available trait when rootworm populations are high, thus 

reducing the economic incentive for a grower to apply insecticide.
130

Appendix B Decision Tree on whether Section 7 Consultation with FWS is Triggered 

for Petitions

This decision tree document is based on the phenotypes (traits) that have been field tested under 

APHIS oversight (for a list of approved field tests, visit Information Systems for Biotechnology.) 

APHIS will re-evaluate and update this decision document as it receives new applications for 

field testing of new traits that are genetically engineered into plants.

BACKGROUND

For each transgene(s)/transgenic plant the following information, data, and questions will be 

addressed by APHIS, and the EAs on each petition will be publicly available. APHIS review 

will encompass: 

• A review of the biology, taxonomy, and weediness potential of the crop plant and its 

sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and the 

nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the 

plant and their quantity;

• A review of the agronomic performance of the plant including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impact;

• Determination of the concentrations of known plant toxicants (if any are known in the 

plant),

• Analysis to determine if the transgenic plant is sexually compatible with any threatened 

or endangered plant species (TES) or a host of any TES.

FDA published a policy in 1992 on foods derived from new plant varieties, including those 

derived from transgenic plants (http://vm.cfsan.fda.gov/~lrd/fr92529b.html and 

http://vm.cfsan.fda.gov/~lrd/consulpr.html). The FDA’s policy requires that genetically 

engineered foods meet the same rigorous safety standards as is required of all other foods. Many 

of the food crops currently being developed using biotechnology do not contain substances that 

are significantly different from those already consumed by human and thus do not require 

pre-market approval. Consistent with its 1992 policy, FDA expects developers to consult with 

the agency on safety and regulatory questions. A list of consultations is available at 

http://vm.cfsan.fda.gov/~lrd/biocon.htmlhttp://vm.cfsan.fda.gov/~lrd/biocon.html. APHIS 

considers the status and conclusion of the FDA consultations in its EAs.

Below is a description of our review process to whether a consultation with U.S. Fish and 

Wildlife Service is necessary. 

If the answer to any of the questions 1-4 below is yes, APHIS will contact FWS to determine if a 
131

consultation is required:

1) Is the transgenic plant sexually compatible with a TE plant12 without human intervention?

2) Are naturally occurring plant toxins (toxicants) or allelochemicals increased over the normal 

concentration range in parental plant species?

3) Does the transgene product or its metabolites have any significant similarities to known 

toxins13)?

4) Will the new phenotype(s) imparted to the transgenic plant allow the plant to be grown or 

employed in new habitats (e.g., outside agro-ecosystem)14? 

5) Does the pest resistance15 gene act by one of the mechanisms listed below? If the answer is 

YES then a consultation with U.S. Fish and Wildlife Service is NOT necessary.

A. The transgene acts only in one or more of the following ways: 

As a structural barrier to either the attachment of the pest to the host, to penetration of the 

host by the pest, to the spread of the pest in the host plant (e.g., the production of 

lignin, callose, thickened cuticles); 

In the plant by inactivating or resisting toxins or other disease causing substances 

produced by the pest; 

By creating a deficiency in the host of a component required for growth of the pest (such 

as with fungi and bacteria); 

By initiating, enhancing, or potentiating the endogenous host hypersensitive disease 

resistance response found in the plant; 

In an indirect manner that does not result in killing or interfering with normal growth, 

development, or behavior of the pest; 

B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such as 

with coat protein, replicase, and pathogen virulence genes).

 12APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to 

the TES plant.

13 Via a comparison of the amino acid sequence of the transgene’s protein with those found in 

the protein databases like PIR, Swiss-Prot and HIV amino acid data bases.

14Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, 

aluminum or heavy metals.

15 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels or 

mitigates a pest or effects any vertebrate or invertebrate animal, plant, or microorganism.
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For the biotechnologist:

Depending on the outcome of the decision tree, initial the appropriate decision below and 

incorporate its language into the EA. Retain a hard copy of this decision document in the 

petition’s file.

________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as 

required under Section 7 of the Endangered Species Act, is needed. APHIS has 

reached a determination that the release following a determination of nonregulated status would have no effects on listed threatened or endangered species 

and consequently, a written concurrence or formal consultation with the Fish and 

Wildlife Service is not required for this EA.

________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as 

required under Section 7 of the Endangered Species Act, is needed. APHIS 

reached a determination that the release following a determination of nonregulated status is not likely to adversely affect any listed threatened or 

endangered species and consequently obtained written concurrence from the Fish 

and Wildlife Service.

________ BRS has reviewed the data in accordance with a process mutually agreed upon 

with the U.S. Fish and Wildlife Service to determine when a consultation, as 

required under Section 7 of the Endangered Species Act, is needed. APHIS 

reached a determination that the release following a determination of nonregulated status is likely to affect adversely one or more listed threatened or 

endangered species and has initiated a formal consultation with the Fish and 

Wildlife Service.