# Pioneer Hi

- Bred International, Inc. Petition (11

- 24 4

- 01p) for Determination of Nonregulated Status of Insect

- Resistant and Herbicide

- Tolerant Pioneer 4114 Maize : Event DP

- 004114

- 3
OECD Unique Identifier: DP

- 004114

- 3 

## Final Environmental Assessment

May 2013 Agency Contact Ci n dy Eck USDA, APHIS , BRS 4700 River Road, Unit 9 1 Riverdale, MD 20737

- 1237 Phone: (301) 734

- 0667 Fax: (301) 734

- 8910 Cynthia.A.Eck@aphis.usda.gov

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family sta tus. (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 emp loyer.

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 agenci es before they can be recommended.DRAFT PIONEER 4114 MAIZE



### TABLE OF CONTENTS

SECTION PAGE

ACRONYMS AND ABBREVIATIONS

................................ ................................ ............... v ii 1 PURPOSE AND NEED

................................ ................................ ................................ ...... 1

1.1 BACKGROUND

................................ ................................ ................................ ............. 1 1.2 PURPOSE OF PRODUCT

................................ ................................ .............................. 2 1.3 COORDINATED FRAMEWORK REVIEW AND REGULATORY REVIEW

.............. 3 1.4 PURPOSE AND NEED FOR USDA

- APHIS ACT ION

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

................................ ................................ ............................. 5 1.6 ISSUES CONSIDERED

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

................................ ................................ ........................... 8

2.1 CORN

– BACKGROUND INFORMATION

................................ ................................ .. 9 2.2 AGRICULTURAL PRODUCTION OF CORN

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

................................ ............................. 10 2.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs

............... 11 2.2.3 Organic Corn Farm ing and Specialty Corn Systems

................................ .......... 23
2.3 PHYSICAL ENVIRONMENT

................................ ................................ ...................... 25
2.3.1 S oil Quality

................................ ................................ ................................ ...... 25 2.3.2 Water Resources

................................ ................................ ............................... 26 2.3.3 Air Quality

................................ ................................ ................................ ....... 2 7 2.3.4 Climate Change

................................ ................................ ................................ 27
2.4 BIOLOGICAL RESOURCES

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

................................ ................................ ........................ 29 2.4.2 Plant Communities

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

................................ ................................ ........................ 37 2.4.4 Biological Diversity

................................ ................................ ......................... 38 2.4.5 Gene Movement

................................ ................................ ............................... 40
2.5 PUBLIC HEALTH

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

................................ ................................ ................................ .. 41 2.5.2 Worker Safety

................................ ................................ ................................ .. 43
2.6 ANIMAL FEED

................................ ................................ ................................ ............ 44 2.7 SOCIOECONOMIC

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

................................ ................................ .... 45 2.7.2 Trade Economic Environment

................................ ................................ .......... 47

iDRAFT PIONEER 4114 MAIZE

3 ALTERNATIVES

................................ ................................ ................................ ............. 49

3.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE

............................... 49 3.2 PREFERRED ALTERNATIVE: DETERMINATION THAT PIONEER 4114 MAIZE IS NO LONGER A REGULATED ARTICLE

................................ ................................ ... 49 3.3 ALTERNATIVES CONSIDERED BUT REJECTED FROM FURTHER CONSIDERATION

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

................................ ... 50 3.3.2 Approve the Petition In Part

................................ ................................ ............. 51 3.3.3 Isolation Distance between Pioneer 4114 Maize and Non

- GE Corn and Geographical Restrictions

................................ ................................ ........................ 51 3.3.4 Requirement of Testing for Pioneer 4114 Maize

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

................................ ................................ ......... 52
4 ENVIRONMENTAL CONSEQUENCES

................................ ................................ ......... 57

4.1 SCOPE OF THE ENVIRONMENTAL ANALYSIS

................................ ..................... 57 4.2 AGRICULTURAL PRODUCTION OF CORN

................................ ............................. 58
4.2.1 Areas and Acreage of Corn Production

................................ ............................. 59 4.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs

............... 60 4.2.3 Organic Corn Farming and Specialty Corn Production

................................ ..... 69
4.3 PHYSICAL ENVIRONMENT

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

................................ ................................ ................................ ...... 72 4.3.2 Water Resources

................................ ................................ ............................... 74 4.3.3 Air Quality

................................ ................................ ................................ ....... 77 4.3.4 Climate Change

................................ ................................ ................................ 78
4.4 BIOLOGICAL RESOURCES

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

................................ ................................ ........................ 79 4.4.2 Plant Communities

................................ ................................ ........................... 85 4.4.3 Soil Microorganisms

................................ ................................ ........................ 91 4.4.4 Biological Diversity

................................ ................................ ......................... 94 4.4.5 Gene Movement

................................ ................................ ............................... 96
4.5 PUBLIC HEATH

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

................................ ................................ ................................ .. 99 4.5.2 Worker Safety

................................ ................................ ................................ 105
4.6 ANIMAL FEED

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

................................ ................................ ................. 107 4.6.2 Preferred Alternative: Animal Feed

................................ ................................ 108

iiDRAFT PIONEER 4114 MAIZE

4.7 SOCIOECONOMIC

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

................................ ................................ .. 109 4.7.2 Trade Economic Environment

................................ ................................ ........ 111
5 CUMULATIVE IMPACTS

................................ ................................ ............................. 113

5.1 ASSUMPTIONS USED FOR THE CUMULATIVE IMPACTS ANALYSIS

............. 113 5.2 CUMULATIVE IMPACTS: AREAS AND ACREAGE OF CORN PRODUCTION

... 116 5 .3 CUMULATIVE IMPACTS: AGRONOMIC PRACTICES: TILLAGE, CROP ROTATION, AND AGRONOMIC INPUTS

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

................................ ................................ ............... 117 5.3.2 Agronomic Inputs

................................ ................................ ........................... 118
5.4 CUMULATIVE IMPACTS: ORGANIC CORN FARMING AND SPECIALTY CORN SYSTEMS

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

................................ ................................ ..................... 120 5.4.2 Specialty Corn Production

................................ ................................ .............. 121
5.5 CUMULATIVE IMPACTS: SOIL QUALITY

................................ ............................ 122 5.6 CUMULATIVE IMPACTS: WATER RESOURCES

................................ .................. 123 5.7 CUMULATIVE IMPACTS: AIR QUALITY

................................ .............................. 124 5.8 CUMULATIVE IMPACTS: CLIMATE CHANGE

................................ ..................... 125 5.9 CUMULATIVE IMPACTS: ANIMAL COMMUNITIES

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

................................ ................................ ........................ 126 5.9.2 Invertebrates

................................ ................................ ................................ ... 127
5.10 CUMULATIVE IMPACTS: PLANT COMMUNITIES

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

...................... 128 5.10.2 Corn as a Weed or Volunteer

................................ ................................ ...... 129
5.11 CUMULATIVE IMPACTS: SOIL MICROORGANISMS

................................ ........ 130 5.1 2 CUMULATIVE IMPACTS: BIOLOGICAL DIVERSITY

................................ ........ 131 5.13 CUMULATIVE IMPACTS: GENE MOVEMENT

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

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

................................ ................................ ............ 132

iiiDRAFT PIONEER 4114 MAIZE

5.14 CUMULATIVE IMPACTS: HUMAN HEALTH

................................ ..................... 133 5.15 CUMULATIVE IMPACTS: WORKER SAFETY

................................ .................... 134 5.16 CUMULATIVE IMPACTS: ANIMAL FEED

................................ .......................... 135 5.17 CUMULATIVE IMPACTS: DOMESTIC ECONOMIC ENVIRONMENT

.............. 136 5.18 CUMULATIVE IMPACTS: TRADE ECONOMIC ENVIRONMENT

..................... 137
6 THREATENED AND ENDANGERED SPECIES

................................ .......................... 138

6.1 USDA

- APHIS’ APPROACH TO EVALUATION OF POTENTIAL IMPACTS TO THREATENED AND ENDANGERED SPECIES

................................ ...................... 138 6.2 POTENTIAL EFFECTS OF THE CULTIVATION OF PIONEER 4114 MAIZE ON TES

................................ ................................ ................................ ............................. 139
6.2.1 Potential Effects of Pioneer 4114 Maize on TES

................................ ............. 140 6.2.2 Potential Effects of the Use of Glufosinate Herbicides

................................ .... 145

7 CONSIDERATION OF EXECUTIVE ORDE RS, STANDARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACTS

................................ .............................. 150

7.1 EXECUTIVE ORDERS WITH DOMESTIC IMPLICATIONS

................................ .. 150 7.2 INTERNATIONAL IMPLICATIONS

................................ ................................ ......... 152 7.3 COMPLIANCE WITH CLEAN WATER ACT AND CLEAN AIR ACT

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

............ 154 7.5 NATIONA L HISTORIC PRESERVATION ACT (NHPA) OF 1966 AS AMENDED 155
8 BIBLIOGRAPHY

................................ ................................ ................................ ........... 157

ivDRAFT PIONEER 4114 MAIZE

LIST OF TABLES
Table 2

- 1. Percentage of herbicide

- resistant, insect

- resistant, stacked trait, total GE corn, and total corn acreage planted in selects states in 2012.

................................ .................. 14 Table 2

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

- EPA.

...... 18 Table 2

- 3. U.S. glyphosate

- resistant (G/9) weeds through July 2012.

................................ ........ 34 Table 2

- 4. Photosystem II inhibitor

- resistant* (C/1) weeds through July 2012.

.......................... 35 Table 2

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

....................... 35 Table 3

- 1. Summary of potential impacts and consequences of alternatives.

.............................. 52 Ta ble 4

- 1. US

- EPA registrations 1 for commercial corn products containing 1507 and/or 59122 Maize.

................................ ................................ ................................ ...................... 64 Table 4

- 2. USDA

- APHIS nonregul ated products expressing the PAT protein conferring resistance to DL

- Phosphinothricin, the ammonium salt of glufosinate, also known as glufosinate ammonium.

................................ ................................ ............................ 66 Table 4

- 3. Comparative control of herbicide

- resistant weeds. (IPM, 2007; Heap, 2012)

............ 88 Table 5

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

................................ ............. 114

LIST OF FIGURES Figure 2

- 1. Percent of to tal corn acres treated with pesticides from 2004

- 2011.

......................... 16 Figure 2

- 2. Adoption of GE corn varieties with at least one herbicide

- resistant trait and glyphosate in U.S. corn production, 1994

– 2010.

................................ .................... 18 Figure 4

- 1. Adoption rates of three major tillag e types in U.S. corn production, 1996

– 2010.

... 61
APPENDICES
APPENDIX A FEDERAL REGISTER NOTICE REGARDING PUBLIC INPUT IN DEREGULATION PROCESS APPENDIX B BAYER LIBERTY ® LABEL APPENDIX C APHIS THREATENED AND ENDANGERED SPECIES DECISION TREE FOR US

- FWS CONSULTATIONS

vDRAFT PIONEER 4114 MAIZE

ACRONYMS AND ABBREVIATIONS

ae Acid equivalent AIA advanced informed agreement AMS Agricultural Market Share or Ammonium sulfate ANZFS Australia and New Zealand Food Standards Agency AOSCA American Organization of Seed Certifying Agencies APHIS Animal and Plant Health Inspection Service BMP Best management practices BRS Biotec hnology Regulatory Services (within USDA

– APHIS) Bt Bacillus thuringiensis protein CAA Clean Air Act CBD Convention on Biological Diversity CEQ Council of Environmental Quality CFR Code of Federal Regulations (United States) CH 4 m ethane CO carbon monoxide CO 2 carbon dioxide COC Crop oil concentrate CRP Conservation Reserve Program Cry Protein The crystalline protein and active ingredient in the plant incorporated protectants derived from Bacillus thuringiensis CWA Clean Water Act DDGs Distillers dry grain solubles DNA deoxyribonucleic acid EA environmental assessment EFSA European Food Safety Agency EIS environmental impact statement EO Executive Order EPA U.S. Environmental Protection Agency EQIP Environmental Quality Incentives Program ESA Endangered Species Act of 1973 ESPP Endangered Species Protection Program FFDCA Federal Food, Drug, and Cosmetic Act

viDRAFT PIONEER 4114 MAIZE

ACRONYMS AND ABBREVIATIONS

FFP food, feed, or processing FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FONSI Finding of No Si gnificant Impact FQPA Food Quality Protection Act g/L grams per liter GE genetically engineered GHG greenhouse gas GMO genetically modified organism HFCS High fructose corn syrup IPCC Intergovernmental Panel on Climate Change IPM Integrated pest management IRM Insect Resistance Management ISHRW International Survey of Herbicide Resistant Weeds ISPM International Standard for Phytosanitary Measure IPPC International Plant Protection Convention L b P ound LMO Living modified organism LOEC Lowest observable effect concentration MOU Memorandum of understanding MSO methylated seed oil N 2 O nitrous oxide NABI North American Biotechnology Initiative NAPPO North American Plant Protection Organization NEPA National Environmental Policy Act of 1969 and subsequent amendments NHPA National Historic Preservation Act NMFS National Marine Fisheries Service NOEC No observable effect concentration NRC National Research Council NRCS National Resources Conservation Service NOP National organic program NPS Non

- point source OECD Organization for Economic Cooperation and Development

viiDRAFT PIONEER 4114 MAIZE

ACRONYMS AND ABBREVIATIONS

PAT phosphinothricin

- acetyl

- transferase, an enzyme

pat The gene derived from Streptomyces viridochromogenes which encodes the PAT enzyme PIP Plant incorporated protectant ppm Parts per million PPRA Plant Pest Risk Assessment PRA pest risk analysis RNA ribonucleic acid RSPM Regional Standards for Phytosanitary Measures SOx Sulfur oxides TES threatened and endangered species TSCA Toxic Substances Control Act U.S. United States US

- FDA U.S. Food and Drug Administration USDA U.S. Department of Agriculture USDA

- APHIS U.S. Department of Agriculture

- Animal and Plant Health Inspection Service USDA

- ERS U.S. Department of Agriculture

- Economic Research Service USDA

- ARMS U.S. Agricultural Resource Management Survey USDA

- FAS U.S. Department of Agriculture

- Foreign Agricultural Service USDA

- NASS U.S. Department of Agriculture

- National Agricultural Statistics Service USC United States Code USFWS U.S. Fish and Wildlife Service VEC Value enhanced corn WPS Worker Protection Standard for Agricultural Pesticides

viiiDRAFT PIONEER 4114 MAIZE



### 1 PURPOSE AND NEED

1.1 BACKGROUND On September 1, 201 1, Pioneer Hi

- Bred International, Inc. of Johnston, Iowa (recently renamed DuPont Pioneer, and referenced hereafter as Pioneer) petition ed (#11

- 244

- 01p) the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) for a determination of nonregulated status of Pioneer 411 4 corn (Maize) event DP

- 004114

- 3 ( Pioneer, 2011b )

. Pioneer 4114 corn (Maize) event DP

- 004114

- 3 is referenced hereafter as Pioneer 4114 Maize

. Pioneer 4114 Maize provides in sect resistance to certain lepidop t eran and coleopteran pests (e.g., European corn borer and corn rootworm, respectively) from the accumulation of three Cry proteins

. Additionally, Pioneer 4114 Maize exhibits resistance 1 to the glufosinate herbicide from the incorporation of the phosphinothricin

- acetyl

- transferase ( PAT ) protein ( Pioneer, 2011b )

. Pioneer 4114 Maize is currently regulated under 7 Code of Federal Regulat ions ( CFR ) Part 340. Interstate movements and field trials of Pioneer 4114 Maize have been conducted under permits issued or notifications acknowledged by USDA

- APHIS since 2006

. These field trials were conducted in diverse growing regions within the United States , including Arkansas, California, Colorado, Delaware, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Nebraska, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas , and Wisconsin

. Data resulting from these field trials are described in the Pioneer 4114 Maize pe tition ( Pioneer, 2011b ) and analyzed for plant pest risk in the USDA

APHIS Plant Pest Risk Assessment (PPRA) ( USDA

- APHIS, 2012e )

. Pioneer’s petition stated that USDA

- APHIS should not regulate Pioneer 4114 Maize because it does not present a plant pest risk. In the event of a determination of nonregulated s tat us, the nonregulated status would include Pion eer 4114 Maize , any progeny derived from crosses between Pioneer 4114 Maize and conventional corn , and crosses of Pioneer 4114 Maize with other biotechnology

- derived corn that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

.

1 “Resistance” to herbicides is def ined by the HRAC (Herbicide Resistance Action Committee) as the inherited ability of a plant population to survive and reproduce following repeated exposure to a dose of herbicide normally lethal to the wild type HRAC, Guideline to the Management of Herbic ide Resistance , 2013, Herbicide Resistance Action Committee, Available: http://www.hracglobal.com/Publications/ManagementofHerbicideResistance.aspx , January 22 2013

. Several technologies are available that can be used to develop herbicide resistance in plants including classical breeding, tissue culture, mutagenesis and genetic engineering. “ Tolerance” is distinguished from resistance and defined by HRAC (2013) as t he inherent ability of a plant to survive and reproduce following exposure to a herbicide treatment. This implies the circumstance in which there is no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant. Throughout this EA (Environmental Assessment), APHIS has used the terms “resistance” and “tolerance” consistent with the definitions of the HRAC. It should be noted however, that different terms for the same concept may be used interchangeably in some instances. In its petition to USDA APHIS (Monsanto, "Petition for the Determination of Non

- Regulated Status Fir Glyphosate

Tolerant Canola Mon 88302 ", ed. M. A. Wideman (Monsanto Company, 2011), vol. referenced the subject as, “Glyphosate

- Tolerant Canola,” and used the t erm “herbicide

- tolerant” throughout it documentation to describe it. This terminology can be considered synonymous with “herbicide

- resistant” (HR) used in this EA.

1DRAFT PIONEER 4114 MAIZE

1.2 PURPOSE OF PRODUCT
Pioneer 4114 Maize is a genetically engineered (GE) insect

- resistant and herbicide

- resistant corn product. Insect resistance in Pioneer 4114 Maize is derived from t he a ccumulation of the insecticidal crystalline proteins 2 Cry1F , Cry34Ab1 , and Cry 35Ab1 ( Pioneer, 2011b )

. Additionally, resistance to the herbicide glufosinate in Pioneer 4114 Maize is conferred through activity of the PAT protein ( Pioneer, 2011b )

. The Cry1F , Cry34Ab1 and Cry 35Ab1 proteins are derived from the common soil bacterium, Bacillus thuringiensis ( Bt ); the PAT protein is derived from a common soil bacterium , S treptomyces viridochromogenes ( Pioneer, 2011b )

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

- APHIS, 2012e )

. Cry1F is effective in controlling lepidopteran larvae such as European corn borer ( Ostrinia nubi l alis ), a major maize pest ( Pioneer, 2011b )

. The Cry34Ab1 and Cry35Ab1 proteins are derived from Bt strain PS149B1 ( USDA

- APHIS, 2012e )

. Together, Cry34Ab1 and Cry35Ab1 comprise an active binary insecticidal crystal protein that confer s resistance to coleopteran corn rootworm pests, including western corn rootworm ( D iabrotica virgifera virgifera ) , also a major maize pest ( Pioneer, 2011b )

. In addition to the Cry1F , Cry34Ab1 , and Cry35Ab1 proteins , Pioneer 4114 Maize also contains the PAT protein , which confers resistance to glufosinate ammonium

- based herbicides. The PAT protein acts to convert glufosinate ammonium into its inactive form, thus rendering the plant resistant to glufosinate ammonium ( Pioneer, 2011b )

. In Pioneer 4114 Maize , the genes for the Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins are contained on a single transformation construct and have been integrated at a single locus in the genome

. T his is in contrast to the commercially

- available 1507 x 59122 Maize variety where the insertions for the events are located at two unlinked loci 3 ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

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

- APHIS, 20 12e ) ; Pioneer 4114 Maize is a corn variety that will provide similar insect resistance / herbicide resistance to that of 1507 x 59122 Maize and function as an alternative to the breeding stack combination of the two previously approved events , 1507 Maize and 59122 Maize

. Pioneer 4114 Maize is not intended to be a stand

- alone commercial product, but will be combined with other approved events using conventional breeding to create stacked and pyramided 4 products with multiple modes of action for control of insect pests and corn weeds

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

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

.

3 In contrast t o a single locus insertion, insertion in two loci means that genes have been inserted in two separate locations within a genome. For example, in 1507 x 59122 Maize, the gene encoding Cry1F is located in one location in the genome; whereas the gene encoding Cry34Ab1/Cry35Ab1 is located in another location in the genome.

4 Stacked products contain two or more genes targeting multiple pests; whereas pyramided products contain two or more genes targeting a single species.

2DRAFT PIONEER 4114 MAIZE

efficiently into new product offerings for growers that are customized to their local insect protection and agronomic needs.
1.3 COO RDINATED FRAMEWORK REVIEW AND REGULATORY REVIEW Since 1986, the United States government has regulated GE organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) ( EOP

- OSTP, 1986 ; US

- FDA, 1992 ) . The Coordinated Framework, published by the Office of Science and Technology Policy, describes the comprehensive Federal regu latory policy for ensuring the safety of biotechnology research and products and explains how Federal agencies will use existing Federal statutes in a manner to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory au thorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonabl e” risk. The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA

- APHIS , the Environmental Protection Agency ( US

- EPA), and the Food and Drug Administration ( US

- FDA).
USDA

- APHIS
USDA

- APHIS regulations at 7 C FR P art 340, which were promulgated pursuant to authority granted by the Plant Protection Act of 2000 , as amended (7 United States Code (U.S.C.) 7701

– 7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act of 2000 or to the regulatory requirements of 7 CFR Part 340 when USDA

- APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the regulati on (7 CFR 340.2) and also is considered a plant pest. A GE organism also is regulated under Part 340 when USDA

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

- APHIS does not have information to determine if the GE organism is u nlikely to pose a plant pest risk. A person may petition the agency that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act of 2000 or th e regulations at 7 CFR 340. The petitioner is required to provide information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodi fied organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 when USDA

- APHIS determines that it is unlikely to pose a plant pest risk.

3DRAFT PIONEER 4114 MAIZE

US

- EPA
The US

- EPA is responsible for regulating the sale, distribution, and use of pesticides, including pesticides that are produced by an organism through techniques of modern biotechnology. The US

- EPA regulates plant incorporated protectants (PIPs) under the Federal Inse cticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 , et seq. ) and certain biological control organisms under the Toxic Substances Control Act (TSCA) (15 U.S.C. 53 , et seq. ). Before planting a crop containing a PIP, a company must seek an experime ntal use permit from US

- EPA

. Commercial production of crops containing PIPs for purposes of seed increases and sale requires a FIFRA Section 3 R egistration with US

- EPA

. Under FIFRA (7 U.S.C. 136 , et seq. ), US

- EPA regulates the use of pesticides (requiring registration of a pesticide for a specific use prior to distribution or sale of the pesticide for a proposed use pattern). US

- EPA examines the ingredients of the pesticide; the particular site or crop on which it is to be used; the amount, frequency, and timing of its use; and storage and disposal practices. Prior to registration for a new use for a new or previously registered pesticide, US

- EPA must determine through testing that the pesticide will not cause unre asonable adverse effects on humans, the environment, and non

- target species when used in accordance with label instructions. US

- EPA must also approve the language used on the pesticide label in accordance with 40 CFR Part 158. Once registered, a pesticide may not be used legally unless the use is consistent with the approved directions for use on the pesticide's label or labeling. The overall intent of the label is to provide clear directions for effective product performance while minimizing risks to human health and the environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling US

- EPA to implement periodic registration review of pesticides to ensure they are meeting current scientific and regulatory standards of safety and continue to have no unreasonable adverse effects ( US

- EPA, 2011d )

. EPA also sets tol erances for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). US

- EPA is required, before establishing pesticide tolerance, to rea ch a safety determination based on a finding of reasonable certainty of no harm under the FFDCA, as amended by the FQPA. US

- FDA enforces the pesticide tolerances set by US

- EPA

. US

- FDA
US

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

- FDA published its policy statement concerning regulation of products derived from new plant varieties, including those derived from GE , in the Federal Register on May 29, 1992 ( U S

FDA, 1992 )

. Under this policy, US

- FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory issues, such as labeling, are resolved before commercial distribution of bioengineered food. This voluntary consultation process provides a way for developers to receive assistance from US

- FDA in complying with their obligations under Federal food safety laws prior to marketing. More recently, in June 2006, US

- FDA published recommendations in “Gui dance for Industry: Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” ( US

- FDA, 2006 ) for establishing

4DRAFT PIONEER 4114 MAIZE

voluntary food safety evaluations for new non

- pesticidal proteins produced by new plant varieties intended to be used as food, including bioengineered plants. Early food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant variety are addressed early in development. These evaluations are not intended as a replacement for a biotechnology consultation with US

- FDA , but the information may be used later in the biotechnology consultation. On December 23, 2011, Pioneer submitted materials in support of a voluntary consultation to the US

- FDA for the Pioneer 4114 Maize ( US

- FDA Docket Number BNF 136)

. US

- FDA completed its evaluation on March 25, 2013.
1.4 PURPOSE AN D NEED FOR USDA
- APHIS ACTION Under the authority of the plant pest provisions of the Plant Protection Act of 2000 and 7 CFR Part 340, USDA

- APHIS has issued regulations for the safe development and use of GE organisms. Any party can petition USDA

- APHIS to seek a determination of nonregulated status for a GE organism that is regulated under 7 CFR 340. As required by 7 CFR 340.6, USDA

APHIS must respond to petitioners that request a determination of the regulated status of GE organisms, including GE plant s such as Pioneer 4114 Maize

. When a petition for nonregulated status is submitted, USDA

- APHIS must make a determination if the GE organism is unlikely to pose a plant pest risk. The petitioner is required to provide information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 when USDA

- APHIS determines that it is unlikely to pose a plant pest risk.
USDA

- APHIS must respond to a Pioneer petition for determination of nonregulated status of Pioneer 4114 Maize

. USDA

- APHIS has prepared this Environmental A ssessment (EA) to consider the potential environmental effects of an agency determination of nonregulated status consistent with Council of Environme ntal Quality’s (CEQ) National Environmental Policy Act of 1969 and subseq uent amendments ( NEPA ) regulations and the USDA and USDA

- APHIS NEPA implementing regulations and procedures (40 CFR Part s 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 5 that may result from a determination of nonregulated status for Pioneer 4114 Maize

. 1.5 PUBLIC INVOLVEMENT
USDA

- APHIS routinely seeks public comment on EAs prepared in response to petitions seeking a determination of nonregulated status of a regulated GE organism. USDA

- APHIS does this through a notice published in the Federal Register

. When USDA

- APHIS considered the petition complete, it prepa red its PPRA and EA, and the three documents were made available for public comment for 60 days through a notice in the Federal Register

. Although USDA

- APHIS ’ review

5 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the relationship of people with that environment” (40 CFR §1508.14).
5DRAFT PIONEER 4114 MAIZE

of the Pioneer 4114 Maize is following a previously established approach, it is also impor tant to ack nowledge that USDA

- APHIS recently has implemented a change to the public involvement process for select future deregulation decisions ( as of March 6, 2012, ( USDA

- APHIS, 2012a ) )

. T he issues raised by this product were relatively straightforward and no new issues were raised. The issues discussed in this EA are those noted in section 1.6 for resourc es and also include those of agricultural production of corn using various production methods and the environmental and food and feed safety of GE plants . These were addressed to analyze the potential environmental impacts of Pioneer 4114 Maize

. This EA, the petition submitted by Pioneer , and USDA

- APHIS ’s PPRA was available for public comment for a period of 60 days (7 CFR § 340.6(d)(2)). Comments received by the end of the 60

- day period w ere analyzed and used to inform USDA

- APHIS ’ determination decision o f the regulated status of Pioneer 4114 Maize and to assist USDA

- APHIS in determining whether an Environmental Impact Statement (EIS) was required prior to the determination decision of the regulated status of this maize variety.
1.6 ISSUES CONSIDERED
The list of resource areas considered in this EA were developed by USDA

- APHIS through experience in considering public concerns and issues raised in public comments submitted for this petition and other EAs of GE organisms. The resource areas considered also addres s concerns raised in previous and unrelated lawsuits, as well as issues that have been raised by various stakeholders for this petition and in the past. The resource areas considered in this EA can be categorized as follows: Agricultural Production Consid erations :

• Areas and Acreage of Corn Production

• Agronomic Practices

• Organic Corn Farming and Specialty Corn Production
Environmental Considerations

• Soil Quality

• Water Resources

• Air Quality

• Climate Change

• Animal Communities

• Plant Communitie s

• Soil Microorgan isms

• Biological Diversity

• Gene Movement
Public Health Considerations

• Human Health

• Worker Safety

6DRAFT PIONEER 4114 MAIZE

Livestock Health Considerations

• Animal Feed /Livestock Health
Socioeconomic Considerations

• Domestic Economic Environment

• Trade Economic Environment
Cumulative I mpact s Threatened and Endangered Species
Other United States Regulatory Approvals and Compliance with Other Laws

7DRAFT PIONEER 4114 MAIZE



### 2 AFFECTED ENVIRONMENT The Affected Environment Section provides an overview of the biology and use of corn 6 (Subsection 2.1

– Corn Background Information) , followed by a discussion of the current condition of those aspects of the human environment potentially affected by a determination of nonregulated status of Pioneer 4114 Maize (Subsections 2.2

– 2.7)

. For this EA, those aspects o f the human environment are: agricultural production of corn (Subsection 2.2) ; the physical environment (Subsection 2.3) ; biological resources (Subsection 2.4) ; public health (Subsection 2.5) ; animal feed (Subsection 2.6) ; and socioeconomic s (Subsection 2. 7)

. Note that alternatives, environmental consequences, cumulative impacts , threatened and endangered species, and consideration of executive orders (EOs) , standards, and treaties relating to environmental impacts are not presented in Section 2, but in Sec tions 3, 4, 5, 6, and 7, respectively. Important to t he description of the Affected Environment and the analysis of Enviro nmental Consequences in this EA, Pioneer 4114 Maize notably contains traits from two GE maize varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

. T he Cry1F protein and its associated genetic elements in Pioneer 4114 Maize are identical to those in DAS

‐ 01507

‐ 1 Maize (hereafter referred to as 1507 Maize ), which had a determination of nonregulated status by USDA, and was registered by the EPA and was reviewed by the US

- FDA in 2001 ( US

- FDA, 2001 ; USDA

APHIS , 2001 ; US

- EPA, 2010f ; Pioneer, 2011b ) . The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements are identical to those in DAS

‐ 59122

‐ 7 Maize (hereafter referred to as 59122 Maize), which had a determination of nonregulated status by USDA in 2005, was registered by US

- EPA in 2005 , and was reviewed by US

- FDA in 2004 ( US

FDA, 2004 ; USDA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 2011b ) . Both 1507 and 59122 Maize contain the PAT protein, which itself has had USDA nonregulated status since 1995 and ha s been commercially cultivated in the United States since 1996 ( USDA

- APHIS, 1995 )

. The regulatory history of 1507 and 59122 Maize bears repeating here because commercial corn hybrids based on these varieties, including a conventional hybrid breeding stack of the two lines, 1507 x 59122 Maize , are now licensed broadly across the seed industry ( Pioneer, 2011b )

. The 1507 x 59122 breeding stack combination was reviewed and registered by US

- EPA in 2005 ( US

EPA, 2010f )

. Similarly, in 2005 , the European Food and Safety Authority (EFSA) approved the marketing of 1507 maize for import, f eed and industrial processing , and cultivation ( EFSA, 2005 ) ; in 2007 , approved 59122 for import, feed and industrial processing ( EFSA, 2007 ) ; and since 2009, has reviewed and approved at least four commercial hybrids based on the 1507 x 59122 hybrid stacks for food and feed uses, import and processing ( EFSA, 2009a ; EFSA ; EFSA, 2010 ; EFSA )

. I n each case , EFSA concluded that th e hybrid product s w ere unlikely to have any adverse effects on human or animal health or on the environment ( EFSA, 2009a ; EFSA ; EFSA, 2010 ; EFSA )

.

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

8DRAFT PIONEER 4114 MAIZE

As of 2011, approximately 88% of all corn planted in the U.S. was GE

. Forty

- nine percent were stacked (multiple) gene varieties having both herbicide

- and insect

- resistant traits ( USDA

- ERS, 2011b ) . Herbicide

- resistant varieties account for 23%, and insect

- resistant

- only cultivars comprised 16%

. In 2010, commercial products containing 1507 x 59122 Maize were grown on approximately 14 million acres or approximately 16% of U.S. maize acres ( GfK Kynetec, 2010 ; Pioneer, 2011b )

. Other value

- added corn GE traits include enhanced oil, starch, or nutritional characteristics and drought tolerance ( USGC, 2010 ; USDA

- APHIS, 2012c ) . The first herbicide

- resistant corn variety released in 1995 was glufosinate resistant and the first stacked hybrid varieties were released in 1997 ( USDA

- APHIS, 2012c ) . The adoption of herbicide

- resistant corn was relatively low in 2000 (approximately 6%) , yet all states surveyed as part of the Economic Research Service ( ERS ) corn estimating program steadily increased their adoption through 20 11 (Figure 4) ( USDA

- ERS, 2011b ) . The amount of herbicide

- resistant

- only corn planted in the U.S. increased between 2000 and 2007 from 6% to 24% of all planted corn, yet has remained relatively steady since then at 22% to 23% of all planted corn ( USDA

- ERS, 2011b )

. In addit ion, adoption of stacked corn varieties (those containing both herbicide

- and insect

- resistant traits) increased from 1% in 2000 to 49% in 2011 ( USDA

- ERS, 2011b )

. Accordingly, as the events contained in Pioneer 4114 Maize are already commercially cultivated, this EA presents a summary of the Cry and the PAT proteins and the events in Pioneer 4114 Maize as part of the Affected Environment an d in the Environmental Consequences analysis.
2.1 CORN

– BACKGROUND INFORMATION Corn ( Z

. mays subsp. mays L. ) is a member of the Maydeae tribe of the grass family, Poaceae ( OECD, 2003 )

. Corn is a wind

- pollinated, monoecious, annual grass species with imperfect flowers 7 ( Wozniak, 2002 ; OECD, 2003 )

. Corn has been domesticated th rough selection of key agronomic characters, such as a non

- shattering rachis, grain yield, and resistance to pests ( Wozniak, 2002 )

. A large variety of corn types (e.g., dent, flint, flour, pop, a nd sweet) have been developed through standard breeding techniques ( Wozniak, 2002 ; OECD, 2003 )

. Corn cultivars and landraces are both known to have two sets of chromosomes with a total number of 20 and consequently , can largely crossbreed. However, some evidence for genetic incompatibility exists within the species (e.g., popcorn x dent crosses; Mexican maize landraces x Chalco teosinte) ( Wozniak, 2002 )

. The closest wild relatives of corn are various Zea taxa known as “teosinte” ( Ellstrand et al., 2007a )

. More than 40 landraces of maize have b een identified in Mexico, and over 250 throughout the Americas ( OECD, 2003 )

. Several of the identified subspecies are identified as teosinte, including Z. mays s ubsp. m exicana ; Z. mays subsp. p arviglumis ; Z ea diploperennis ; and Z ea luxurians ( OECD, 2003 ; Ellstrand et al., 2007a )

. None of the teosinte subspecies are known to oc cur naturally north of the tropical and subtropical areas of Mexico, Guatemala, Honduras, and Nicaragua ( Sanchez et al., 2011 ) , although teosinte

7 A morphological f eature that limits inbreeding , where s patially separate tassels (male flowers) and silks (female flowers) are found on the same plant, , Gene Flow Assessment for Plant

- Incorporated Protectants by the Biopesticide and Pollution Prevention Division, U.S. Epa : The Ohio State University.

.

9DRAFT PIONEER 4114 MAIZE

may be found as introduced populations in botanical gardens and as feral populations of Z ea mexicana in Florida, Maryland, and Alabama ( USDA

- NRCS, 2012b ) , and feral populations of Z

ea perennis in South Carolin a ( USDA

- NRCS, 2012c )

. Corn has food, feed , and industrial uses ( USDA

- ERS, 2012c )

. A variety of food and industrial products are derived from corn , including starch es 8 , sweeteners 9 , corn oil, organic acids, and alcohols 10 ( CRA, 201 1 ; Pioneer, 2011b ) . In 2012, approximately 45% of total U.S. corn production was dedicated to ethanol production for biofuels and 42% for animal feed ( USDA

ERS, 2012c ) . In addition to being cultivated for ethanol and animal feed production, approximately 6% of the total corn production is harvested for silage ( USDA

- NASS, 2012c )

. 2.2 AGRICULTURAL PRODUCTION OF CORN

2.2.1 Areas and Acreage of Corn Production Corn is an annual plant typically grown in zones of abundant rainfall and fertile soils ( OECD, 2003 )

. In U.S. temperate regions , moisture levels and number of frost

- free days are ideal for corn to be grown (see, e.g., IPM, 2004 ; IPM, 2007 ) . However, through selective breeding to variable conditions of humidity, sunlight, altitude, and temperature , corn is cultivated in a var iety of regions in the United States ( OECD, 2003 )

. Corn is grown in all 48 states of the continental U nited States , with production concentrated in the U.S. Cor n Belt

. The Corn Belt is loosely defined as the states of Illinois, Iowa, Indiana, the eastern portions of South Dakota and Nebraska, western Kentucky and Ohio, and the northern two

- thirds of Missouri ( USDA

- NASS, 2012b ) . Iowa and Illinois, the two top corn

- producing states, typically account for slightly more than one

- third of the total U.S. corn crop ( USDA

NASS, 2012b )

. In the 2012 production year, corn was cultivated in the United States on approximately 96 million acres, representing a 5% increase in corn acreage from 2011 ( USDA

- NASS, 2012b )

. Corn production in 2011 was estimated at 12.44 billion bushels and valued at an estimated $5.15 to $5.65 per bushel ( USDA

- NASS, 2012b )

. Corn is the most widely cultivated feed grain in the United States, accounting for approximately 96% of total value and production of feed grains ( USDA

- ERS, 2012c )

. In addition to demand as feed grain, s trong demand for ethanol production has resulted in higher corn prices and corresponding incentives to growers to increase corn acreage ( USDA

- ERS, 2012c ) . In many cases, growers have increased corn acreage by adjusting corn plantings between corn, soybean, and other crops ( USDA

- ERS, 2012c )

.

8 Starches include unmodifi ed and modified starch es, dextrin , and maltodextrin

.

9 Sweeteners include glucose, dextrose, fructose, and high

- fructose corn syrup

.

10 Alcohols include beverage, industrial and fuel ethanols.

10DRAFT PIONEER 4114 MAIZE

2.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs Agronomic practices associ ated with corn production include several crop management systems that are available to growers

. Conventional farming , as defined in this document , includes any farming system where synthetic pesticides or fertilizers may be used. This type of farming may vary between occasional use of synthetic pesticides and fertilizers to those that depend on regular inputs for successful crop production. This definition of conventional farming may also include the use of GE corn varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

. Organic systems exclude certain production methods, such as synthetic agricultural inputs and GE crops, and are discussed i n Subsection 2.2.3

– Organic Corn Farming and Specialty Corn Systems. Growers can choose from several different crop management practices depending upon geographic cultivation area and end

- use market (see, e.g., IPM, 2004 ; IPM, 2007 )

. However,
c om mon corn agronomic practices include tillage, the selection of crop rotation system, and the use of agronomic inputs. The following subsections introduce the basic cultivation requirements of corn and the agronomic practices commonly employed to produce co rn in the United States.
2.2.2.1 Tillage Prior to planting of corn seed, t illage may be used to p repare a seedbed , a ddress soil compaction , i ncorpor ate fertilizers and herbicides , m anage water movement both within and out of a production field , c ontrol weeds , and r educe the incidence of insect pests and plant disease ( Hoeft et al., 2000 ; C hristensen, 2002 ; Fawcett and Towery, 2002 ; Tacker et al., 2006 ; Givens et al., 2009 ; NRC, 2010 )

. Field preparation is accomplished through a variety of tillage systems, with each system defined by the remaining plant residue on the field. Conventional tillage is associated with intensive plowing and less than 15% crop residue in the field; reduced tillage is associated with 15 to 30% crop residue; and conservation tillage is associated with at least 30% crop residue remaining in the field ( US

- EPA, 2009 )

. Conservation tillage includes no
- till, mulch

- till, no
- til l fallow, strip

till, ridge

- till, and zero
- till practices ( IPM, 2007 )

. Conservation tillage is valued as a means to enhance soil quality , preserve soil m oisture , and reduce soil erosion ( USDA

- ERS, 1997 ; USDA

NRCS, 2005 ; Heatherly et al., 2009 )

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

• Desired yields;

• Soil type and moisture storage capacity;

• Crop rotation pattern;

• Prevalence of insect and weed pests;

• Risk of soil compaction and erosion;

• The need for crop residue or animal was te disposal; and

• Management and time constraints. Tillage can increase yields in some cropping systems and soils, and not in others. For example, if a tillage system increases moisture infiltration, production potentially increases in response. Tillage c an also impact the amount of agronomic inputs needed to maintain soil fertility and
11DRAFT PIONEER 4114 MAIZE

moisture and the amount of agricultural chemicals needed to control insect and weed pests ( Olson and Sander, 1988 ; Hoeft et al., 2000 ; Cerdeira and Duke, 2006 )

. According to the 2010 USDA Agricultural Resource Management Survey ( USDA

- ARMS), an average of 1.4 tillage operations per corn crop were conducted , leaving an average of 34% plant residue on the soil surface after planting ( USDA

- ERS, 2011c ) . The plant residue coverage of the soil after planting w as approximately 65% for no

- till corn production in 2005; however, no

- till corn production represented only 24% of all corn acres planted in the United States ( USDA

ERS, 2011c ) . In 2010, 62% of planted corn acreage in 19 surveyed states was dedicated to no

- till or minimum till systems ( USDA

- NASS, 2011d )

. Increases in total acres dedicated to conservation tillage have been attributed to increased use of GE crops, reducing th e ne ed for mechanical weed control. However, the change in tillage practices in corn was less dramatic than other crops such as soybean or cotton, as many growers of corn had already changed to conservation tillage systems as a means to reduce soil erosion ( Faw cett and Towery, 2002 ; Givens et al., 2009 )

. C onservation tillage has been identified as a potential challenge for corn disease management. The surface residues have been identified as an inoculum sou rce for certain plant pathogens 11 ( Robertson et al., 2009 )

. This is especially a problem for growers who cultivate corn

- to

- corn with minimal tillage ( Robertson et al., 2009 )

. Corn

- to

- corn cultivation is discussed in the followi ng subsection, and refers to the cultivation of corn in consecutive years in the same field ( Erickson and Lowenberg

- DeBoer, 2005 )

. For each of these diseases, the disease agent overwinters in the cool and moist soil, and the pathogenic inoculum from the corn residue then infects the ne xt year ’s crop ( Robertson et al., 2009 )

. Recommended d isease control measures are already practiced and include cultivation of resistant hybrids, crop rotation, and more careful balancing of conservation tillage with residue management , with resistant hybr ids the most economical method ( Robertson et al., 2009 )

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

. Crop rotation may be used to optimize soil nutrition and fertility, red uce pathogen loads, control volunteers 12 , and limit the potential for weeds to develop resistance to herbicides ( IPM, 2004 ; USDA

- ERS, 2005 ; IPM, 2007 )

. Since 1991, 75% of corn planted acreage has been in some form of rotation in the United States ( USDA

- ERS, 2005 )

. Corn can be grown successfully in conservation tillage system if rotated with other crops , such as wheat or soybean, which may reduce some of the problems encountered with conservation tillage ( IPM, 2007 )

. Other c rops

11 Diseases identified as related to corn residues include Anthra cnose (caused by the fungus Colletotrichium graminicola ), Eyespot (caused by the fungus Kabatiella zea ), Goss’s wilt (caused by the bacteria Corynebactierum nebraskense ), Gray leaf spot (caused by the fungus Cercospora zeae

- maydis ), and Northern corn leaf blight (caused by the fungus Helminthosporium turcicum ) A. Robertson, R.F. Nyvall and C.A. Martinson, Controlling Corn Diseases in Conservation Tillage (Ames, IA: Iowa State University, University Extension, 2009).

.

12 See Subsection 2.4.2.2

– Corn as a Weed or Volunteer.

12DRAFT PIONEER 4114 MAIZE

used in rotation with corn vary regionally and may include cotton, oats, canola, sugar beets, peanut, rye, barley and forage ( Peel, 1998 ; see e.g., IPM, 2004 ; Pioneer, 2012 )

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

- Kaisi et al., 2003 ) :

• Improved yield and profitability of one or both crops;

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

• Increased residue cover resulti ng in reduced soil erosion;

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

• Reduced soil erosion;

• Increased soil organic matter;

• Improved soil tilth and soil physical properties; and

• Reduced runoff of nutrients, herbicides, and insecticides

. The high global demand for corn

- produced ethanol is increasing corn prices relative to soybean prices. The increased corn demand and commodity prices encourage more corn

- to

- corn acreage, rather than corn

- soybean rotations, which in turn contribute to ove rall increased U.S. corn acreage ( Doerge, 2007 )

. Consecutive plantings of corn require more management than corn

soybean rotations, and increase risk of disease and insect pest pressure ( IPM, 2004 ; Erickson and Lowenberg

- DeBoer, 2005 ; Sawyer, 2007 ; Stockton, 2007 )

. Consecutive plantings of corn also have been associated with the development of resistance by western corn rootworm ( D. virgifera ) and other pests to management practices utilizing Bt ( Gassmann et al., 2011 )

. Bt

resistance is further discussed in Subsection 2.4.1.2

– Inver tebrates.
2.2.2.3 Agronomic Inputs Corn production typically involves the extensive use of agronomic inputs to maximize grain yield ( Ritchie et al., 2008 )

. Agronomic inputs may include fertili zers to supplement available nutrients in the soil; pesticides to reduce pest plant, insect, and microbial populations; and irrigation to ensure normal plant growth and development ( Howell et al., 1998 ; IPM, 2007 )

. Fertilizer and pesticide use is discussed in this subsection; i rrigation is discussed in Subsection 2.3.2

– Water Resources

. Fertilization Given the importance of nutrient availability to corn agronomic performance, fertilization is widely practiced ( Ritchie et al., 2008 )

. Soil and foliar macronutrient applications to cor n primarily include nitrogen, phosphorous (phosphate), potassium (potash), calcium , and sulfur, with other micronutrient supplements such as zinc, iron, and magnesium applied as needed ( Espinoza and Ross, 2006 )

. In a 2010 survey of program states, USDA

- NASS reported that nitrogen was applied to 97% of corn acreage at an average of 140 pounds per a cre ( lb. /acre); phosphate was applied to 78% of corn acreage at an average rate of 60 lb. /acre; and potash was applied to 61% of corn acreage at a rate of 7 9 lb. /acre ( USDA

- NASS, 2011a )

. The survey found that sulfur was applied less e xtensively at a rate of 13 lb. /acre to 15 % of corn acres ( USDA

NASS, 2011a )

.

13DRAFT PIONEER 4114 MAIZE

Pesticides
Cornfields are hos t to a variety of insect and plant pests that reduce both the quality and quantity of grain at harvest

. Due to improvements in pesticide technology, corn growers have increasingly turned to chemical control in corn production ( Smith and Scott, 2006 )

. Pesticides may be applied pre

- planting 13 , pre
- emergence 14 , or post

- emergence 15

. Pesticide application strategies are often dependent on the corn variety cultivated. Growers may choose from a large number of corn varieties produced from traditional breeding or GE systems ( NCGA, 2012 )

. Like the major commodity crops , cotton and soybean, GE varieties of corn have been adopted widely in the past decade. In 2000, approximately 25% of cultiva ted corn varieties were GE. This included 18% insect

- resistant varieties, 6% herbicide

- resistant varieties, and 1% stacked varieties ( Benbrook, 2009 )

. By 2011, total GE corn adoption had increased to 88% of U.S. corn acreage. GE insect

- resist ant varieties represented 16% of this total ; whereas GE herbicide

- resistant and GE stacked varieties represented 23% and 49%, respectively ( NCGA, 2012 ; USDA

- NASS, 2012b )

. Table 2

- 1 shows the current GE corn adoption rates in the United States.
Table 2

- 1
. Percentage of herbicide

- resistant , insect

- resistant, stacked trait, total GE corn, and total corn acreage planted in selects states in 2012
.

State Herbicide

resistant (%) Insect

- resistant ( Bt ) (%) Stacked * (%) Total GE (%) Total Corn Acreage Planted ( 1 000 acres) Illinois 18 14 53 85 13,000 Indiana 15 9 60 84 6,200 Iowa 15 12 64 91 14,000 Kansas 19 20 51 90 4,700 Michigan 26 8 52 86 2,600 Minnesota 22 19 47 88 8,700 Missouri 20 18 48 86 3,600 Nebraska 20 16 55 91 9,900 North Dakota 36 17 43 96 3,400 Ohio 20 13 43 76 3,900 South Dakota 23 9 62 94 6,000 Texas 21 20 44 85 1,900 Wisconsin 23 10 53 86 4,350 Total United States 21 15 52 88 96,450

* Stacked corn varieties contain at least one herbicide

- resistant trait

. Source: ( USDA

- NASS, 2012b ) Factors influencing the adoption of insect

- resistant crops include ( Brookes and Barfoot, 2010 ) :

13 Before the crop seed has been planted, i.e. “burn

- down” herbicide application.

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

15 After crop seed germination.

14DRAFT PIONEER 4114 MAIZE

• Reduced risk of crop loss associated with insect pests;

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

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

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

• Improved quality (e.g. , lower levels of mycotoxins 16 in GE insect

- resistant corn ) ;

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

• Easier crop husbandry practices; and

• Facilitat ion of second crop cultivation. Factors influencing the adoption of herbicide

- resistant crops include ( Brookes and Barfoot, 2010 ) :

• Ease of use associated with broad

- spectrum, post

- emergent herbicides and the increased/longer time window for spraying;

• Reduction in damage to crop arising from the application of post

- eme rgent herbicides;

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

• Time and fuel savings from the adoption of no/reduced till compared to equivalent conventional crop management practices;

• Ease of weed control leadi ng to cleaner crops and reduced harvesting time and costs, and thereby improving harvest quality and premium price for quality; and

• Avoidance of potential damage from soil

- incorporated residual herbicides in crops grown in subsequent season s

. The selectio n of an insect

- resistant and/ or herbicide

- resistant variety influences a corn grower’s pest management strategy

. Figure 2

- 1 shows the percent of total corn acres treated with the major types of agricultural pesticides from 2004

– 2011. The graph suggests t hat herbicide use as a percent of total corn acres h as remained relatively constan t, insecticide use has decreased, seed treatments have substantially increased, and foliar fungicide applications have increased to a lesser extent. Further discussion of these trends is presented in the following subsections on insecticides, herbicides , and microbial pest management.

16 Mycotoxins are compounds produced by some corn fungal pathogens that may pose a human health risk. A well

known example is aflatoxin, produced by the fungus genus Aspergillus

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

15DRAFT PIONEER 4114 MAIZE

Figure 2

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

- 2011.

Source: ( Pioneer, 2011b )
Pesticides

- Insecticides In 2010, a pproximately 12 % of corn acreage was treated with insecticides, with the most abundantly applied (listed in order of t otal pounds applied) being chlorpyrifos for corn rootworm , earworms , and European corn borer ( 1 % of the acreage, with total applications of approximately 478,000 pounds ) ; tefluthrin for control of corn rootworm ( 3 % of the acreage, with total applications o f 242,000 pounds ) ; and tebupirimphos for corn rootworm and seed corn maggot ( 2 % of the acreage, with total applications of 195,000 pounds ) ( USDA

- NASS, 2011a )

. Most seed corn, both conventional and GE, is treated with insecticide in order to combat corn pests which attack the seed ( Pioneer, 2011b ) . Chemical insecticides commonly used in corn seed treatment control seed corn insect pests such as flea beetles (which vector bacterial wilts), cutworm larvae, seedcorn maggots, white grubs, and wireworms include imidacloprid, clothianidin, fipronil, permethrin, and thiam ethoxam (Whitworth et al., 2013)

. The introduction of Cry proteins from B

. thuringiensis into corn plants has transformed insect pest management. There has been a steady decline in the application of insecticides in recent years attributed, in part, to the adoption of corn varieties incorporating these Cry proteins ( Brookes and Barfoot, 2010 ; Benbrook, 2012 ) . The Cry proteins from Bt are generally target specific (e.g., L epidoptera vs. C oleopter a) ( OECD, 2007 )

. This target specificity allows a grower to select a corn variety containing a Cry protein specific to an insect pest . F or example, Cry1F in 1507 Maize target s lepidopteran pests and Cry34Ab1/Cry35Ab1 in 59122 Maize to target coleopteran pests ( Pioneer, 2011b ; Pioneer, 2012 )

. The advantage of this target specificity is that the grower can then avoid the application of broad

- spectrum insecticides ( Brookes and Barfoot, 2010 ) , allowing corn growers to reduce insecticide applications ( Brookes and Barfoot, 2010 ; Benbrook, 2012 ) . This provid es benefits to growers and the environment from the reduction of exposure to insecticides and a corresponding reduction in costs to the grower associated with insecticide purchases and applications ( US

- EPA, 2010b ; US

- EPA, 2010a ; US

- EPA, 2010f )

.
16DRAFT PIONEER 4114 MAIZE

In 2012, 52% of the total U.S. corn acreage was planted in a stacked variety containing at least
one Bt t rait ( USDA

- NASS, 2012b )

. The US

- EPA reviews PIPs, such as the Cry proteins, pursuant to FIFRA, and publishes exemptions from tolerance pursuant to its authority under FFDCA . Since 1995, the US

- EPA has registered over 35 crops expressing one or more proteins derived from Bt ( US

- EPA, 2011b )

. Table 2

- 2 provides a summary list of the PIP s registered b y the US

- EPA

. The US

- EPA has published full tolerance exemptions for the Cry proteins ( US

EPA, 2007a ) 17

. Pesticides

- Herbicides Herbicides were applied to 9 8 % of corn acreage in 20 10 ( USDA

- NASS, 2011a )

. A 2010 survey of corn growers showed the fol lowing three herbicides as the most commonly applied: glyphosate ( 66 % of the acreage, ~ 57 million pounds) ; atrazine (6 1 % of the acreage, ~ 51 million pounds applied) ; and acetochlor (2 5 % of the acreage, ~ 28 million pounds) ( USDA

- NASS, 2011b ; USDA

- NASS, 2011a )

. Of the glyphosate totals, most (89.4%) w as in the form of glyphosate isopropylamine salt; 8.2 % of was in the form of glyphosate ; 0.07 % was in the form of glyphosate ammonium salt ; and 2.4 % was in the form of glyphosate potassium salt. An unspecified amount of glyphosate dimethylamine salt was u sed in 2010 ( USDA

- NASS, 2011a )

.

17 As noted in Subsection 1.3, under its FFDCA authority, the E PA will publish an exemption from the requirement for a tolerance when it has completed comprehensive review of the toxicity and exposure data and completed health and animal risk assessment studies see http://www.epa.gov/opp00001/factsheets/stprf.htm#some for an overview of the EPA tolerance exemption processUS

- EPA, Setting Tolerances for Pesticide Residues in Foods , 2012f, Available: http://www.epa.gov/pesticides/factsheets/st prf.htm, 11 October 2012.

. An exemption from tolerance for the Cry proteins means that the EPA completed its review and found a reasonable certainty of no harm under the FFDCA, as amended by the FQPA.

17DRAFT PIONEER 4114 MAIZE

Table 2

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

- EPA.

PIP Event Crop Registration Date

Cry 3A Bt Potato May, 1995 Cry 1Ab Bt Corn August, 1995 Cry 1Ac Bt Cotton October 1995 Cry 9C Bt Corn May, 1998 Cry 1F * Bt Corn May, 2001 Cry 3Bb1 Bt Corn February 2003 Cry 34Ab1 and Cry 35Ab1 * Bt Corn August, 2005 Cry 2Ab2 Bt Cotton September, 2005 Vip3Aa19 Bt Cotton June, 2006 Vip 3Aa20 Bt Corn February 2008 Note: This table presents a summary of the US

- EPA ’s PIP Registrations since 1995. Multiple registrations of the same PIP event are not shown. The complete US

- EPA PIP Registration list can be found at http:// www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm * Represents PIPs present in Pioneer 4114 Maize, the subject of this EA. Like insect

- resistant corn varieties, the introduction of herbicide

- resistant corn varieties has substantially affected how corn i s produced in the United States

. The introduction of herbicide

resistant corn varieties allowed the post

- emergent application of some herbicides, simplifying a grower’s weed management strategy. In particular, glyphosate

- resistant corn varieties have stron gly influenced weed management strategies (Figure 2

- 2)

. Although glyphosate

- resistant corn has not substantially affected the percentage of corn acreage managed with herbicide s, the introduction of glyphosate

- resistant
corn varieties has resulted in the substitution of glyphosate for some other corn herbicides (Figure 2

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

. Figure 2

- 2 . Adoption of GE corn varieties with at least one herbicide

- resistant trait and glyphosate in U.S. corn production, 1994

– 2010.

Source: USDA

- ERS ( 2011a ) and USDA

- NASS ( 1996 ; 2002 ; 2006 ; 2011a )

.

In ad dition to glyphosate

- resistant corn varieties, glufosinate

- resistant corn varieties are also cultivated in the United States. Glyphosate

- resistant and glufosinate

- resistant corn are the most 0 20 40 60 80

1994 2001 2005 2010Percent of U.S. corn acreage

Year GE adoption Glyphosate use

18DRAFT PIONEER 4114 MAIZE

common GE herbicide

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

- 4 illustrates the percent of U.S. cor n acres treated with glyphosate or glufosinate. Figure 2

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

Source: ( Pioneer, 2011b )

.
Although glufosinate

- resistant corn has been available since 1996, the use of glufosinate on total corn acres has remained stable and low over the past decade, with between 2% and 6% of the total U.S. corn acreage treated with glufosinate ( Pioneer, 2011b )

. In 2010, 515,000 lbs. of glufosinate was applied to 2% of U.S. corn acreage ( USDA

- NASS, 2011e )

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

- NASS, 2011e )

. Growers have selected glyphosate over glufosinate based on several reasons, including ( Pioneer, 2011b ) :

• Glufosinate has l imited systemic activity compared to glyphosate;

• Higher volumes of water (and higher pressure in spray nozzles) are needed for glufosinate compared to glyphosate;

• The window of application for effective control of weeds for glufosinate is narrower than f or glyphosate;

• Popularity of glyphosate

- resistant soybeans allows for growers to use glyphosate on all their GE crops in a corn/soybean operation; and

• Potentially higher relative cost of glufosinate compared to glyphosate. Long

- term trends related to herbicide use resulting from the utilization of GE technologies are the subject of much debate ( Benbrook, 2009 ; Fernandez

- Cornejo et al., 2009 ; Brookes and Barfoot, 2010 ; Benbrook, 2012 ; Brookes and Barfoot, 2012 )

. Benbrook reported that the adoption of herbicide

- resistant crops has resulted in an increase in the volume of herbicides
19DRAFT PIONEER 4114 MAIZE

applied to crops (see, e.g., Benbrook , 2009 ; Benbrook, 2012 )

. Benbrook noted that between 1996 and 2001 , herbicide use declined apparently in direct response to the adoption of herbicide

resistant crops

. H owever, since 2001 , herbicide use has increased ( Benbrook, 2009 ; Benbrook, 2012 )

. Benbrook suggests that the r eported increases in herbicide use during the last decade reflect an increase in glyphosate applications as more glyphosate

- resistant crops are planted with an associated i ncrease in use of other herbicides used to control glyphosate

- resistant weeds ( Benbrook, 2009 ; Benbrook, 2012 )

. Other authors interpret the herbicide use data differently (see, Brookes and Barfoot, 2012 ; Brookes et al., 2012 )

. Benbrook's analysis of trends in herbicide use is based on assumptions that may lead to overestimates of herbicide use in herbicide

- resistant crop programs, including assumptions of herbicide usage on conventional crops that may be underestimated, extrapolation of trends to years wher e no USDA data are available, and not accounting for the role of increased crop acreage in the estimated increases in herbicide use ( Brookes et al., 2012 )

. Further, Benbrook’s analysis fails to consider the differing environmental profiles of herbicides use d, particularly the substitution of relatively environmentally benign products for those with less environmentally friendly profiles ( Brookes et al., 2012 )

. In contrast to Benbrook's findings, Brookes and Barfoot ( 2012 ) estimate that GM crop adoption in the United States reduced the use of pesticides in the United States by 246 million kg compared to what might reasonably be expected if GM crops were no longer available.

T otal use (i.e., pounds of active ingredient per acre) does not reflect the environmental fate or toxicity of the herbicide. Consequently, the total use metric does not allow comparison of herbicides. In 2011, it was estimated that g lyphosate was applied to approximately 80% of U.S. corn acres ( Pioneer, 2011b )

. However, increased selection pressure resulting from the wide

- spread adoption of glyphosate

- resistant crops, along with the reductions in the use of other herbicides and weed management practices, has resulted in both weed population shifts and increasing glyphosate resistance among some weed populations ( Owen, 2008 ; Duke and Powles )

. The emergence of resistance to herbicides is not exclusive to glyphosate

- resistant crops and corresponding weed species ( Norsworthy et al., 2012 )

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

- spread adoption of herbicide

- resistant crops, especially GE

- derived glyphosate

- resistant crops, has dramatically changed the approach that farmers take to avoid yield losses from weeds ( Gianessi, 2008 ; Duke and Powles, 2009b )

. Subsection 2.4

– Biological Resources, provides a discussion on the role of herbicide

- resistant weeds in corn weed managemen t.
To reduce development of resistant weeds , growers can continually practice weed management strategies by choosing different herbicides with alternative modes of action, including auxin growth regulators, amino acid inhibitors, chlorophyll pigment inhibitors, or lipid biosynthesis inhibitors ( Ross and Childs, 2011 )

. The practice of using herbicides with alternative modes of action could potentially diminish the populations of glyphosate

- resistant weeds and reduce the likelihood of the development of new herbicide

- resistant weed populations ( Dill et al., 2008 ; Duke and Powles, 2008 ; Owen, 2008 ; Duke and Powles, 2009b ; Pioneer, 2011b ; Norsworthy et al., 2012 ; Vencill et a l., 2012 )

.

20DRAFT PIONEER 4114 MAIZE

Weed control methods differ depending on a number of factors including regional practices, grower resources, and crop trait; the techniques may be direct (e.g., mechanical, biological, and chemical) or indirect (e.g., cultural ) ( Hoeft et al., 2000 )

. Additionally, w eed managemen t strategies need to be carefully planned to integrate appropriate technologies into an economic level of control ( Shaw et al., 2011 ) . A diverse strategy is essential to reduce selection pressure on the weed population ( Powles and Preston, 2009 )

. Recently, the Weed Science Society of America presented a series of best management practices (BMPs) to address herbicide resistance in weeds. These recommendations are ( Norsworthy et al., 2012 ) :

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

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

• Communicate that discovery of new, effective herbicide MOAs is rare and that the existing herbicide resource is exhaustible;

• Demonstrate the benefits and costs of proactive, diversified weed

- management systems for the mitigation of HR [herbicide

- resistant] weeds;

• Fos ter the development of incentives by government agencies and industry that conserve critical herbicide MOAs as a means to encourage adoption of best practices;

• Promote the application of full

- labeled rates at the appropriate weed and crop growth stage. Whe n tank mixtures are employed to control the range of weeds present in a field, each product should be used at the specified label rate appropriate for the weeds present.

• Identify and promote individual BMPs that fit specific farming segments with the great est potential impact;

• Engage the public and private sectors in the promotion of BMPs, including those concerning appropriate herbicide use; and

• Direct federal, state, and industry finding to research addressing the substantial knowledge gaps in BMPs for he rbicide resistance and to support cooperative extension services as vital agents in education for resistance management.
Glufosinate The herbicide glufosinate ammonium was first registered with the US

- EPA in 1993 for home,
non
- food and farmstead weed contr ol uses ( OSTP, 2001 ) , and received its first crop

- product registration in 2000 ( US

- EPA, 2008b ) . The US

- EPA has published exemptions for resistance for both glufosinate and the PAT protein ( US

- EPA, 2010d ) . Glufosinate is a non

- selective foliar herbicide that is used for pre

- plant and post

- emergence control of broadleaf weeds. Glufosinate inhibits glutamine synthetase, resulting in the overproduction of ammonia in plant tissues and ultimately resulting in plant death ( US

- EPA, 2008 b )

. Glufosinate is available in several formulations, and is sold under the trade names Basta, Ignite, Rely, Liberty ® , Remove, AEH, Finale, and Derringer F. A copy of a sample label for Liberty ® , a Bayer formulation, is provided in Appendix B . Although the Liberty ® label limits the use of that formulation to corn, soybeans, and canola resistant to the product, glufosinate ammonium is registered for use on apples, berries, canola, corn, cotton, currants, grapes, grass grown for seed,
21DRAFT PIONEER 4114 MAIZE

potatoes, rice, soyb eans, sugar beets, and tree nuts ( US

- EPA, 2008b ) . Registrations for non

- crop areas include golf course turf, residential lawns, ornamentals, and a variety of industrial, residential, and public areas ( US

- EPA, 2008b ) . Aerial and ground spraying are allowed, with a wide range of application rates. The mode of action is not changed by these formulations and applications, but the chemical and physical properties of each formulation influence the selecti on of equipment, mitigation measures adopted in the field to minimize off

- target impacts, and formulation

- specific safety
measures. Glufosinate is not a dermal irritant or a dermal sensitizer and has been deemed a toxicity category III for acute oral, derm al, and inhalation toxicity ( US

- EPA, 2003 ) . Glufosinate is highly water soluble (1,370 g/L), and has a half

- life in soil ranging f rom 3 to 70 days, dependent upon soil type and moisture content ( Clewis et al., 2008 ; Jariani et al., 2010 )

. As of the March 2008 Glufosinate Summary Document Registration Review , there were insufficient data available on terrestrial plant toxicity for an ecological assessment to be completed ( US

- EPA, 2008b ) . Based on the data collected as of th e 2008 review summary, however, the areas of concern are impacts to non

- target plants, chronic toxicity to mammals, and the indirect impacts to terrestrial animals from potential alterations in aquatic plant communities ( US

- EPA, 2 008b ) . The EPA requires additional plant toxicity and field dissipation studies to determine potential impacts of typical end

- use products. Existing environmental assessments of the toxicity of glufosinate to animal species indicated a relatively low di rect risk, but high risk to plants composing the animals’ habitat ( US

- EPA, 2008b ) . On an acute exposure basis, glufosinate is considered practically nontoxic to birds, mammals, and insects; slightly non

- toxic to freshwater fish ; slightly toxic to estuarine/marine fish; moderately toxic to freshwater and estuarine/marine invertebrates; and toxic to terrestrial and aquatic plants ( US

- EPA, 2008b ) . For birds, glufosinate is practically non

- toxic on an ac ute and subacute dietary basis; therefore, the risk potential is presumed to be low ( US

- EPA, 2008b )

. The US

- EPA label for this herbicide includes use restrictions and safety measures. FIFRA requires that registered herbicides be applied in accordance with these label restrictions.
Pesticides

- Fungicides In addition to pesticide inputs to control invertebrates (insecticides) and weeds (herbicides ) , growers may also apply fungicides to control certain fungal diseases on corn. These treatments include both foliar fungicide applications to treat certain diseases as well as seed treatments to manage both insect pests of corn seed as well as certain fungal diseases. This practice is not universal, and varies by grower and region de pending upo n the specific disease ( Hoeft et al., 2000 ; Ruhl, 2007 )

. Some of the common fungal diseases on corn include Anthracnose leaf blight ( C

. graminicola ) , common rust ( Puccinia sorghi ) , eyespot ( K

. zeae ) , gray leaf spot ( C

. zea
maydis ) , northern corn leaf blight ( Exserohilum turcicum ), northern corn leaf spot ( Bipolaris zeicola ) , and seed rot (multiple causes, fungal and bacterial, see, e.g., Hoeft et al., 2000 ; Ruhl, 2007 )

. Historically, foliar applications of fungicides were not common, and fungal disease management was focused on selection of disease

- resistant hybrids, crop rotation to break the disease cycle , and tillage to enco urage decomposition of crop residues that were reservoirs for the disease ( see, e.g., Purdue, 2012 ) The corn

- to

- corn rotations discussed previously in Subsection 2.2.2.2

– Crop

22DRAFT PIONEER 4114 MAIZE

Rot ation , along with conservation tillage, has resulted in an increased disease risk in some areas ( Robertson et al., 2007 ; Robertson and Mueller, 2007 )

. Corn yields have been reported to increase as a result of these foliar applications of fungicides ( Robertson and Mueller, 2007 )

. 2.2.3 Organic Corn Farming and Specialty Corn Systems
2.2.3.1 Organic Corn
In the U nited States , only crops produced using specific methods and certified under USDA ’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” ( Ronald and Fouche, 2006 ; USDA

- AMS, 2010 )

. The NOP is administered by USDA’s AMS. The USDA maintains current infor mation on the domestic organic commodity market at: http://www.nal.usda.gov/afsic/pubs/organicstats.shtml

. Organic certification is a process

- based certification, not a certification of the end product. The certification process specifies and audits the methods and procedures by which the product is produced ( Ronald and Fouche, 2006 )

. In accordance with NOP, an accredited organic certifying agent conducts an annual review of the certified operation’s o rganic system plan and makes on

site inspections of the certified operation and its records. Organic growers must maintain records to show that production and handling procedures comply with USDA organic standards. The NOP regulations preclude the use of excluded methods. The NOP provides the following guidance under 7 CFR §205.105

— To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or group(s)),” the product must be produced and handled without the use of: (a) Synthetic substances and ingredients,... (e) Excluded methods,... Excluded methods are then defined at 7 CFR §205.2 as

— A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible u nder natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. Organic farming operations, as described by the NOP, require organic production operations to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management. There is no specific size of a

23DRAFT PIONEER 4114 MAIZE

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

. Organic production operations also must develop and maintain an organic production system plan approved by their accredited certifying agent. This plan enables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition on the use of excluded methods. In NOP organic systems, the use of GE crops is excluded ( USDA

- AMS, 2010 )

. Common practices organic growers may use to e xclude GE products include planting only organic seed, planting earlier or later than neighboring farmers who may be using GE crops so that the crops will flower at different times, and employing adequate isolation distances between the organic fields and the fields of neighbors to minimize the chance that pollen will be carried between the fields ( NCAT, 2003 )

. Although the National Organic Standards prohibit the use of excluded methods, they do not require testing of inputs or pro ducts for the presence of excluded methods. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of the National Organic Standards ( USDA

- AMS, 2010 )

. The current NOP regulat ions do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labeled product. The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

- AMS, 2010 )

. The organic farming plan used as the basis for organic certification should include a descript ion of practices used to prevent or reduce the likelihood of unwanted substances, like GE pollen or seed, at each step in the farming operation, such as planting, harvesting, storing, and transporting the crop ( Kuepper, 2002 ; Riddle, 2004 ; Krueger, 2007 ; Roth, 2011 )

. Organic corn production begins with certified organically grown seed ( Diver et al., 2008 )

. The adventitious presence of GE material in organic corn is a concern because corn naturally cross

- pollinates ( Coulter et al., 2010 )

. Although GE pollen is frequently cited as a concern, non

- organic products can be introduced accidently from impure seed; seed admixture; volunteer plants; and res idual non

organic seed in the equipment, vehicles, and facilities ( Coulter et al., 2010 ; Mallory

- Smith and Sanchez

- Olguin, 2011 )

. Organic farming plans should include how the ris k of GE pollen or co

mingling of seed will be monitored ( Roth, 2011 )

. Farmers using organic methods are requested to let neighboring farmers know that they are using organic production practices and request that the neighbors also help the organic farmer reduce potential contamination events ( NCAT, 2003 ; Krueger, 2007 )

. Delayed planting has been used successfully by some organic corn producers to control weeds and to avoid potential contamination by G E pollen from adjacent fields ( Roth, 2011 )

. The late planting allows the organic corn grower to conduct a secondary tillage pass before planting to control early emerged weeds . Moreover, the late planting results in a later silking in the corn flower thereby avoiding pollen contamination from GE fields which have been planted earlier ( Roth, 2011 )

. Although con ventional corn yields (e.g., bushels per acre) tend to be higher than organic yields, net returns (e.g., price per bushel) from organic acres continue to be greater than net return s from conventional acres, with a 16% premium received for organic growers reported in 2008 ( Kuepper, 2002 ; Coulter et al., 2010 ; Roth, 2011 )

. Certified organic corn acreage is a relatively small percentage of overall corn production in the U nited States

. The most re cently available

24DRAFT PIONEER 4114 MAIZE

data show 169,000 acres of certified organic corn production in 20 11, which represent ed approximately 0.20% of the 9 2 million acres of corn planted in 201 1 ( USDA

- NASS, 2012a )

. The approximately 169,000 acres in 2011 represent a decrease from the approximately 195,000 certified organic corn acres cultivated in 2008 ( USDA

- NASS, 2012a )

. 2.2.3.2 Specialty Corn Thomison and Geyer ( 2011 ) estimated that approximately 5% of the total U.S. corn acreage, or approximately 4 million ac res, was devoted to specialty corn varieties. Specialty corn varieties have been developed and marketed as Value Enhanced Corn (VEC) ( USDA

- FAS, 2004 )

. Varieties cultivated as specialty corn included high oil, white, waxy, blue corn, hard endosperm/food grade, high

- amylose, high lysine, high oleic oil, low phytate, nutritionally enhanced, high extractable starch , high total fermentable (for ethanol), popcorn, pharmaceutical and industrial corns, and organic ( Thomison and Geyer, 2011 )

. The leading specialty corn states include Illinois, Iowa , Nebraska, and Indiana ( Thomison and Geyer, 2011 )

. Similar to the production of conventional seed, industry quality standards for specialty crop products have led these seed producers and growers to employ a variety of techniques to ensure that their products are not pollinated by or commingled with conven tional or GE crops ( Bradford, 2006 )

. Common practices include mainta ining isolation distances to prevent pollen movement from other corn sources, planting border or barrier rows to intercept pollen, and employing natural vegetative barriers to pollen , including fallow fields and hedgerows ( Wozniak, 2002 ; NCAT, 2003 )

. The Federal Seed Act Regulations provide additional details on Certified seed production (see 7 CFR §201, et seq

. )

. Field monitoring for off

- types is generally carried out by company staff and state crop improvement associations ( Bradford, 2006 )

. Seed handli ng standards are established by the American Organization of Seed Certifying Agencies ( AOSCA ) to reduce the likelihood of seed source mixing during planting, harvesting, transporting, storage, cleaning, and ginning ( AOSCA, 2004 )

. In general, the conventional management practices used for conventional s eed production are sufficient to meet standards for the production of specialty crop seed ( Bradford, 2006 )

. 2.3 PHYSICAL ENVIRONMENT
2.3.1 Soil Quality Soil quality on managed lands may be directly affected by the agricultural practices on that land ( USDA

- NRCS, 2006c )

. In particular, soil quality of agricultural land is directly affected by tillage strategies. As discussed in S ubsection 2.2.2.1, t illage is an integral part of production agriculture ( Givens et al., 2009 )

. Conservation practices, including conservation tillage, have been developed to reduce field tillage and thus reduce the corresponding soil erosion and runoff ( USDA

- NRCS, 2006c )

. By definition, conservation tillage leaves at least 30% of the soil covered by crop residue ( Peet, 2001 )

. In conservation tillage programs, t he new crop is planted into the plant residue or in narrow strips of tilled soil. This is in comparison to conventional tillage where the seedbed is disrupted through plowing (to turn the soil surface over), disking (to reduce the size of soil clods created by plowing), and harrowing (to reduce the size of clods left by dis king) ( Peet, 2001 )

.

25DRAFT PIONEER 4114 MAIZE

As conservation tillage practices have been adopted, there is a corresponding benefit to s oil. In addition to an increase in soil organic matter, t otal soil loss on highly erodible croplands and
non
- highly erodible croplands decreased from 462 million tons per year to 281 million tons per year or by 39.2% from 1982 to 2003 ( USDA

- NRCS, 2006b )

. The reduction in soil erosion is also attributed to a decrease in the number of acres of highly erodible cropland being cultivated ( USDA

- NRCS, 2006b )

. This decrease in soil erosion carries a corresponding benefit in water
reso urces, and will be discussed in S ubsect i on 2.3.2

– Water Resources

. C orn tillage strategies may directly and indirectly affect soil quality. C orn plant residues remaining in a field in a conservation tillage production system may impede cultivation equipment and cause cool, wet soils ( Werblow, 2007 )

. Cool, wet soils can delay germination and cause yield losses up to 10% ( Neilsen, 2010 )

. These concern s can each be addressed through a number of corn cultivation techniques, including corn varieties developed to thrive in cool, wet soils; seed treatments for insect and disease control; selection of appropriate equipment to manage high

- residue conditions; and judicious use of appropriate herbicides to control weeds remaining in the conservation tillage fields ( NCGA, 2007b ; Werblow, 2007 )

. 2.3.2 Water Resources
Corn is a water

- sensitive crop with a relatively low tolerance for dro ught compared to other cultivated crops

. Corn requires approximately 4,000 gallons through the growing season to produce one bushel of grain , or approximately 600,000 gallons per acre for each growing season ( NCGA, 2007a )

. Corn stress response and its respective water demand is variable over the growing season, with the greatest water demand occurring during the silk production stage in mid

- season ( Farahani and Smith, 2011 ) . During this stage, the water requirement is estimated at approximately two inches of water per week (or 0.3 inches per day) ( Heiniger, 2000 ; Farahani and Smith, 2011 )

. Corn water demand is met by a combination of natural rainfall, stored soil moisture from precipitation before the growing season, and sometimes supplemental irrigation during the growing season ( Heiniger, 2000 ; Farahani and Smith, 2011 )

. The vast majority of corn acreage does not require supplemental irrigation ( USDA

- NASS, 2009 )

. In 2010, approximately 11 million U.S. corn acres were irrigated, representing approximately 9% of the total corn acreage ( NCGA, 2009 )

. However, for those corn acres that require supplemental moisture, g roundwater is the major source of water for irrigation and is used on almost 90% of irrigated corn acreage in the U nited States ( Christensen, 2002 )

. In addition to direct use of water, a gricultural production of corn may affect water resources through erosion and runoff of nutrients and suspended sediments fro m farm fields , and infiltration of groundwater by supplemental nutrients and pesticide s

. This type of non

- point source ( NPS ) pollution is the primary source of water quality impacts on surveyed rivers and lakes and a major contributor to groundwater contam ination. Common m anagement practices that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the application of pesticides, herbicides, and fertilizers. The primary cause of NPS pollution, however, is increased sedime ntation in surface waters following soil erosion ( US

- EPA, 2005 )

. Agricultural pollutants released by soil erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and streams when they are carried off fields by rain or i rrigation

26DRAFT PIONEER 4114 MAIZE

waters ( US

- EPA, 2 005 )

. Increase d sediment loads to surface waters can directly affect fish, aquatic invertebrates, and other wildlife maintenance and survival. It also reduces the amount of light penetration in water which directly affects aquatic plants. S oil erosion

- m ediated sedimentation may also increase fertilizer runoff, thereby increasing nutrient loading and facilitating higher water turbidity, algal blooms, and oxygen depletion ( US

- EPA, 2005 )

. 2.3.3 Air Quality Agricultural production of corn may affect air quality in direct and indirect wa ys. Agriculture directly affects air quality through common agricultural practices and may include smoke from agricultural burning and vehicle exhaust associated with agricultural equipment. In particular,
a erial application of pesticides may cause air quality i mpacts from drift and diffusion ; p esticides also may volatilize after application or may move with the wind as droplets or as constituents of entrained materials in wind

- eroded soils ( Vogel et al., 2008 )

. Agricultural production of corn may also indirectly affect air quality throu gh common management practices, such as the emission of greenhouse gases (GHG , i.e., carbon dioxide ) from tillage or the use of nitrogen fertilizer ( i.e., nitrous oxide) ( Hoeft et al., 2000 ; USDA

NRCS, 2006a ; Aneja et al., 2009 ; US

- EPA, 2012b )

. Many of the conservation plans and practices being developed by growers have an air quality focus which target reductions in air emissions from agricultural operations ( USDA

- NRCS, 2006a )

. Practices to improve air quality include conservation tillage, residue management, wind breaks, road treatments, burn management, prunings shredding, feed management, manure
ma nagement, integrated pest management, chemical storage, nutrient management, fertilizer injection, chemigation and fertigation (inclusion in irrigation systems), conservation irrigation, scrubbers, and equipment calibration ( USDA

- NRCS, 2006a )

. Conservation tillage practices resulting in improved air quality include: fewer tractor passes across a field, thus decreasing dust generation and tractor emissions; and an i ncrease in surface plant residues and untilled organic matter which physically hold the soil in place and reduce wind erosion ( Baker et al., 2005 ; USDA

- NRCS, 2006a )

. The USDA has estimated that the adoption of conservation management plans in the San Joaquin Valley of California had reduced air emissions by 34 tons daily, or more than 20% of the total em issions attributed to agricultural practices after a year of implementation ( Baker et al., 2005 ; USDA

- NRCS, 2006a )

. 2.3.4 Climate Change Climate change represents a statistical change in global climate conditions, including shifts in the frequency of extreme weather

. Agriculture is recognized as a direct (e.g., exhaust from equipment) and indirect (e.g., agri cultural

- r elated soil disturbance) source of GHG emissions. Agriculture, including land

- use changes for farming, is responsible for an estimated 6% of all human

- induced GHG in the U nited States ( US

- EPA, 2012b )

. Emissions of GHG released from agricultural equipment (e.g., irrigation pumps and tractors) include carbon monoxide (CO) , nitrogen oxides (N 2 O), methane (CH 4 ), reactive organic gases, particulate matter, and sulfur oxides (SO x ) ( US

- EPA, 2012b ) . Nitrous oxides, methane and carbon dioxide are the primary GHGs resulting from agricultural activities ( US

- EPA, 2012b )

. Agricultural soil management practices, including nitrogen

- based fertilizer application and cropping practices, represent the

27DRAFT PIONEER 4114 MAIZE

largest source of U.S. nitrous oxide emissions; croplands account for 6 8 % of the total N 2 O emissions attributable to agricultural land uses ( US

- EPA, 2012b )

. Agricultur al sources of methane emissions are associated primarily with enteric emissions of gas from cattle and manure management. Carbon dioxide also is a substantial GHG associated wit h several agricultural practices, including certain land uses and energy consumption ( US

- EPA ; US

- EPA, 2012c )

. The contribution of agriculture to climate change largely is dependent on the production practices employed , the region in which the commodities are grown, and the individual choices made by growers. For example, emissions of nitrous oxide, produced naturally in soils through microbial nitrificati on and denitrification, can be influenced dramatically by fertilization, introduction of grazing animals, cultivation of nitrogen

- fixing crops and forage (e.g., alfalfa), retention of crop residues (i.e., no

- till conservation), irrigation, and fallowing of land ( US

- EPA, 2012b )

. These same agricultural practices can influence the decomposition of carbon

- containing organic matter sequestered in soil, resulting in conversion to carbon dioxide and subsequent loss to the atmosphere ( US

- EPA, 2012b )

. On

- site emissions associated with farm machinery can be reduced by half for some crops when changing from conventional tillage to no

- till systems ( Nelson et al., 2009 )

. Conve rsion of crop land to pasture results in increase nitrogen sequestration in soils ( US

- EPA, 2012b )

. Tillage contributes to the release of GHG because of the loss of carbon dioxide (CO 2 ) to the atmosphere, and the exposure and oxidation of soil organic matter ( Baker et al., 2005 )

. N o
- till practices generally sequester more carbon in the soil due to less soil disturbance, higher soil moisture, and increased biomass inputs from surface residues ( West, N.D. ) . The gross carbon sequestration value used for corn, taken from the national assessment data, is 595 kg carbon /ha/yr (approximately 530 lb s/acre) ( West, N.D. )

. Corn crops using no

- till practices have the potential to sequester an additional net 288 kg carbon /ha/yr ( approximately 263 lb s/acre) compared to conventional tillage ( West, N.D. )

. The carbon footprint of corn is directly affected by its associated cultivation practices ; c orn cultivation has been estimated to produce higher total CO 2 emissions than wheat or soybean, and lower total emissions than cotton or rice ( Nelson et al., 2009 )

. The US

- EPA has identified regional differences in GHG emissions associated with agricultural practices on different soil types, noting that carbon emission rates differ between mineral soils and organic soils ( US

- EPA, 2012b )

. Mineral soils contain from 1 to 6% organic carbon by weight in their natural s tate; whereas organic soils may contain as much as 20% carbon by weight ( US

- EPA, 2012b )

. In mineral soils, up to 50% of the soil organic carbon can be released to the atmosphere on the initial conversion; however, over time, the soil establishes a new equilibrium that reflects a balance between carbon inputs from decaying pl ant matter and organic amendments and carbon losses from microbial decomposition ( US

- EPA, 2012b )

. Organic soils, with their depth and richness in carbon content, continue to release carbon to the atmosphere for a longer period of time ( US

- EPA, 2012b )

. The US

- EPA has estimated that mineral soil

- based cropland areas sequestered over 45.7 Tg CO 2 Eq 18 in 2008, as compared with carbon emissions from organic soil

- based croplands of 27.7 Tg CO 2 Eq ( US

- EPA, 2012b )

. The adoption of

18 The global warming potential of greenhouse gases are measured against the reference gas CO 2 , and are reported as teragrams (or million metric tons) of CO 2 Equivalent, expressed as Tg CO 2 Eq

.

28DRAFT PIONEER 4114 MAIZE

conservation tillage, particularly in the Midwest regions with mineral soil shows the highest rates of carbon sequestration ( US

- EPA, 2012b )

. Although agriculture may influence climate change, climate change may reciprocally affect agriculture. In response to climate change, the current range of weeds and pes ts of agriculture may increase ( Field et al., 2007 )

. Current agricultural practices will be required to change in response to these changes in the ranges of weeds and pests of agriculture ( Field et al., 2007 )

. Climate change potentially may also provide a positive impact to agriculture in general. The Intergovernmental Panel on Climate Change ( IPCC) predicts that potential climate change in North America may result in an increase in crop yield by 5

- 20% for this century ( Field et al., 2007 )

. However, this positive impact will not be observed across all growing regions. The IPCC report notes that certain regions of the United States will be impacted negatively because the available water resources may be reduced substantially. Note that the extent of climate change effects on agriculture is highly speculative. Nevertheless, North American production is expected to adapt to climate change impacts with improved cultivars and responsive farm management ( Field et al., 2007 )

. 2.4 BIOLOGICAL RESOURCES

2.4.1 Animal Communities
2.4.1.1 Birds and Mammals Compared to natural areas, agricultural production fields generally have reduced animal populations ( Dale et al., 2010 )

. However , c orn production fields may be host to a variety of animal species , despite m onoculture conditions and perpetual disturbances (e.g., planting and harvesting) associated with common agricultural practices ( Palmer et al., 1992 ; Vercauteren and Hygnostrom, 1993 )

. S ome birds and mammals may use cornfields at various times throughout the corn production cycle for reproduction, though most birds and mammals that utilize cornfields are ground

- foraging omnivores that feed on the corn grain remaining in the fields following harvest ( Palmer et al., 1992 ; Vercauteren and Hygnostrom, 1993 ; Krapu et al., 2004 )

. The types and numbers of birds that inhabit cornfields may vary regionally and seasonally ; however, the numbers are low in general , although some of the birds are considered agricultural pests ( Patterson and Best, 1996 ; see also: Purdue, 2010 )

. Most of the birds that utilize cornfields are ground

- foraging omnivores that feed on corn seed, sprouting corn, and the corn remaining in the fields following harvest. Bird spec ies commonly observed foraging on corn include ( Dolbeer, 1990 ; Patterson and Best, 1996 ; Purdue ; Southern States, 2010 ; Mullen, 2011 ) :

• R ed

- winged blackbird ( Agelaius phoeniceus );

• Grackle ( Quiscalus quiscula);

• H orned lark ( Eremophila alpestris );

• B rown
- headed cowbird ( Molothrus ater );

• V esper sparrow ( Pooecetes gramineus );

• R ing

- necked pheasant ( Phasianus colchicus );

• W ild turkey ( Meleagris gallopavo) ;

29DRAFT PIONEER 4114 MAIZE

• American crow ( Corvus brachyrhynchos ); and

• V arious quail species

. Following harvest, it is common to find large flocks of Canada ge ese ( Branta canadensis ), s now geese ( Chen caerulescens ), s andhill cranes ( Grus canadensis ), and other migratory waterfowl in cornfields ( Sparling and Krapu, 1994 ; Taft and Elphick, 2007 ; Sherfy et al., 2011 )

. Depending on the region , a variety of mammals may also forage in a cornfield

. For the most part, herbivorous and omnivorous mammals f eed on the ear at various stages of growth. Large

- to medium

- sized mammals that are common foragers of cornfields include ( ODNR, 2001 ; DeVault et al., 2007 ; Stewart et al., 2007 ; Beasley and Rhodes Jr., 2008 ; Illinois, 2012 ) :

• W hite

- tailed deer ( Odocoileus virginianus ) ;

• R accoon ( Procyon lotor ) ;

• F eral pigs ( Sus scrofa ) ; and

• W oodchuck ( Marmota monax )

. The most notable of these are the white

- tailed deer and raccoon. White

- tailed deer often inhabit woodlots adjacent to cornfields and frequent these fields for both food and cover throughout the latter half of the corn growing season ( Vercauteren and Hygnostrom, 1993 )

. The effects of
w hite

- tailed deer herbivory are well documented ( Vercauteren and Hygnostrom, 1993 ) and white

- tailed deer are considered responsible for more corn damage than any other wildlife species ( Stewart et al., 2007 )

. In addition to deer, substantial d amage to corn by raccoons also has been documented ( DeVault et al., 2007 ; Beasley and Rhodes Jr., 2008 )

. Corn has been shown to c onstitute up to 65% of the diet of raccoons in some areas during the fall ( MacGowan et al., 2006 )

. As with these larger mammals, small mammal use of cornfields for shelter and forage also varies regionally and includes ( Stallma n and Best, 1996 ; Sterner et al., 2003 ; Smith, 2005 ) :

• Deer mouse ( Peromyscus maniculatus ) ;

• House mouse ( Mus musculu s ) ;

• Meadow vole ( Microtus pennsylvanicus ) ; and

• T hirteen

- lined ground squirrel ( Spermophilus tridecemlineatus )

. T he deer mouse is common ly found in agricultural field s ( Stallman and Best, 1996 ; Illinois, 2000 ; Sterner et al., 2003 )

. Deer mice fe ed on a wide variety of plant and animal matter depending on availability , but primarily feed on seeds and insects. Deer mice have been considered beneficial in agro

- ecosystems because they consume both weed and insect pests ( Smith, 2005 )

. The house mouse is primarily a seed and grain feeder, commonly found in the weedy e dges of reduced tillage fields ( Illinois, 2000 ) . Most crop damage by this mouse is done between planting and crop emergence ( Illinois, 2000 )

. The meadow vole feeds primarily on fresh grass, sedges, and herbs, and also on seeds and grains of field crops. Although the meadow vole may be considered beneficial for its role in the consumption of weeds, the vole can be a substantial agricultural pest where abundant and when it
consumes corn seeds in the field. The vole is often associated with the field edges where cover is

30DRAFT PIONEER 4114 MAIZE

found off the field as well as where limited tillage agriculture and strip crops are found ( Smith, 2005 ) . The lined ground squirrel feeds primarily on seeds of weeds and available crops, such as corn and wheat. This species has the potential to damage agricultural crops, although like the meadow vole, it also can be considered beneficial when eating pest insects, such as grasshoppers and cutworms ( Smith, 2005 )

. 2.4.1.2 Invertebrates
As noted in Subsection 2.4.1.1

– B irds and Mammals , common agricultural practices , particularly monoculture cultivation , may reduce diversity in managed fields. T his net reduction in species is not limited to birds and mammals; invertebrates are also affected ( Landis et al., 2005 )

. In spite of this, the i nvertebrate communit y in cornfields represent s a diverse assemblage of feeding strategies ( Stevenson et al., 2002 )

. N umerous insects and related arthropods may perform valuable functions: t hey pollinate plants, contribute to the decay and processing of organic matter, reduce weed populations, and cycle soil nutrients

. Arthropods may also feed upon insects and mites that are considered to be pests ( Ruiz et al., 2008 )

. Some of these beneficial predatory species include the convergent lady beetle ( Hippodamia convergens ), carabid beetles (Family Cara bidae) , parasitoids (e.g., Macrocentrus cingulum ), and the predatory mite ( Phytoseiulus persimilis ) ( Shelton, 2011 )

. The most agronomically

- relevant invertebrates in corn production fields are those arthropods that feed on corn plant s and adversely affect grain yield

. These include lepidopteran s pecies that feed on the corn ear or stalk and coleopteran species that feed on other corn vegetative structures. Major lepidopteran and coleopteran insect pests in the United States include European corn borer and western corn rootworm, respectively. The European corn borer is present in every corn growing state except Arizona, California, Idaho, Nevada, Oregon, Utah, and Washington ( ISU, 2012 )

. Western corn rootworm has been reported as active in every corn growing state, with the exceptions of California, Florida, Lo uisiana, Nevada, Oregon and Washington ( Edwards and Kiss, 2012 )

. In the United States, monetary losses and expenses related to European corn borer and corn rootworm exceed $1 billion/year for each pest ( Ostlie et al., 2002 ; Gray et al., 2009 )

. As noted in S ubsection 2.2.2.3

– Agronomic Inputs, t he advent of GE Bt corn targeting these major insect pests has enabled a reduction in input costs by decreasing the number and volume of broad

- spectrum insecticide application in U.S. corn cultivation ( Brookes and Barfoot, 2010 ; Benbrook, 2012 )

. Although Bt corn has proven successful in controlling targeted insect pests since their introduction in 1996, there have been several reports of resistance by target pests in the United States, India, and South Africa ( Tabashnik and Gould, 2012 )

. For example, Gassmann ( 2011 ) reported pockets of corn rootworm resistance to one type of Bt corn in several locations in Iowa ( Gassmann et al., 2011 ) ; and the US

- EPA has confirmed resistance to Cry1F to Fall armyworm in Puerto Rico ( US

- EPA, 2010b ; Storer et al. , 2012 )

. In both the Iowa and the Puerto Rico reports, these resistant populations were associated with fields where growers had cultivated consecutive years of corn expressing the same Cry protein. The emergence of these resistant populations has been attributed to the grower’s failure to adhere to the refuge strategy ( s ee, e.g., Storer et al., 2012 )

.
31DRAFT PIONEER 4114 MAIZE

As a condition of Bt registrations by US

- EPA , registrants are required to develop insect resistance management (IRM) programs to delay the development of insect resistance to Cry proteins . Examples of the limitations and conditions currently implemented for the Bt proteins in corn can be found in the EPA document, Terms and Conditions for Bt Corn Registrations ( US

EPA, 2010f ) . As part of this program, growers of traditional Bt corn products are required to plant a non

- Bt corn refuge ( US

- EPA, 2010f ) . Such a refuge can consist of a field or a block or strip of non

- Bt corn ( US

- EP A, 2010f ) . Recently, the US

- EPA also has approved an integrated refuge strategy, named “refuge in a bag”, where non

- Bt seeds are blended with the Bt corn products and planted randomly within the field ( Pioneer, 2012 ) . Successful development and implementation of the refuge strategy requires an understanding of the genetic foundation of insect pest resistance. Incipient resistance to Cry proteins has been reported i n target insect pests before being exposed to the Cry proteins ( Mahon et al., 2012 )

. This resistance trait is considered a recessive allele; susceptibility to the Cry protein is considered the dom inant trait ( Tabashnik and Gould, 2012 )

. As a recessive trait, the frequency of express ion of this trait is low in an unexposed population ( Tabashnik and Gould, 2012 )

. Howeve r, when the same population of target pests is exposed to the same Cry protein over several generations, the recessive resistance trait allows those individuals carrying that allele to survive and reproduce, conferring the resistance trait to their offspri ng as a greater percentage of the pest population ( Tabashnik and Gould, 2012 )

. The refu ge strategy provides non

- Bt corn where susceptible target insects (e.g., European corn borer and/or corn rootworms) can feed, mate and reproduce without exposure to the Bt corn and the Cry proteins, maintaining a genetic reservoir of susceptible target pes ts that express the dominant trait ( US

- EPA, 2010f ; Pioneer, 2012 ) . Future mating interactions with these susceptible insects (i.e., those that have not been exposed to Bt proteins) with those that have been exposed to the Bt proteins and survived based on the resistance allele will ensure that Bt resistance does not become the dominant allele in the population ( Pioneer, 2012 )

. Despite some evidence of Bt resistance, w idespread failure of control measures using Bt crops has not been observed, in part due to IRM strategies. IRM strategies generally include supplemental pesticide use and the planting of refuges ( Tabashnik et al., 2008 ) . In the case of Bt corn grown in the Corn Belt, refuge acres are typically 5 % to 20 % of the cornf ield area, depending on the product’s requirements ( US

- EPA, 2010f ) . Resistance management strategies, which are mandated by US

- EPA’s terms of Bt corn product registrations ( US

- EPA, 2010f ) have been developed for all Bt corn products to mitigate the risk of pest resistance and to implement additional measures if resistance occur s.
2.4.2 Plant Communities
2.4.2.1 Surrounding Landscapes and Other Vegetation in Cornfields Cornfields may be bordered by other field crops or by woodlands, hedgerows, rangelands, or pasture/grassland areas. These surrounding plant communities may occur naturally or th ey may be managed for the control of soil and wind erosion. The vegetation adjacent to a cornfield is often dependent on the geographic region where the corn is planted.
Corn generally is cultivated as a monoculture ( Dale et al., 2010 )

. Members of the plant community that adversely affect corn cul tivation may be characterized as weeds. The types of weeds in and around a cornfield depend on the local landscape in which the corn is planted ( IPM,

32DRAFT PIONEER 4114 MAIZE

2004 2007 ; IPM, 2007 ; University of California, 2009 ; Purdue, 2011 )

. Some of the most
common weeds in cornfields located in North Central Region of the United States include ( Purdue, 2012 ) :

• G iant foxtail ( Setaria faberi ) ;

• G iant ragweed ( Ambrosia trifida ) ;

• V elvetleaf ( Abutilon theophrasti ) ;

• C ommon lambsquarters ( Chenopodium album ) ;

• C ommon ragweed ( Ambrosia artemisiifolia) ;

• C ommon cocklebur ( Xanthium pensylvanicum ) ;

• Canada thistle ( Cirsium arvense) ;

• J ohnsongrass ( Sorghum halepense ) ;

• F all panicum ( Panicum dichotomiflorum ) ; and

• M arestail ( Conyza canadensis )

. New weeds emerge as cropping practices change and growers fail to recognize or properly identify a plant as a weed ( Iowa State University Extension, 2003 ) . For example, in addition to the common weeds listed above, the Iowa State University Extension office has listed the following as “Weeds to Watch: New Weed Threats for Corn and Soybean Fields” ( Iowa State University Extension, 2003 ) :

• C ressleaf groundsel ( Senecio glabellus ) ;

• P urple deadnettle ( Lamium purpureum) ;

• B iennial wormwood ( Artemisia biennis ) ;

• Asiatic dayflower ( Commelina communis) ;

• H ophornbeam copperleaf ( A calypha ostryfolia ) ;

• B urcucumber ( Sicyos angulatus ) ;

• W ild buckwheat ( Polygonum convolvulus ) ;

• K ochia ( Kochia scoparia) ;

• W aterhemp ( Amaranthus rudis) ;

• P almer amaranth ( Amaranthus palmeri) ;

• S tar

- of

- Bethlehem ( Ornithogalum umbellatum ) ;

• W hite campion ( Silene latifolia ) ;

• W ild four o' clock ( Mirabilis nyctaginea ) ; and

• P okeweed ( Phytolacca americana )

. Weed control is an important aspect of corn cultivation. Weed control typically involves an integrated approach that includes timely applications of herbicide, crop rotation, weed surveillance, and weed monitoring ( Farnham, 2001 ; IPM, 2004 ; IPM, 2007 ; Hartzler, 2008 ; University of California, 2009 )

. Data have been collected on weed population densities by species, crop yield , and crop production system economics with the intent of providing gro wers with insights into the sustainability and profitability of diversified weed management programs ( Shaw et al., 2011 ) . To assist growers in managing weeds, individual states, typically through their state agricultural extension service, list the prevalent weeds in corn crops in their area and

33DRAFT PIONEER 4114 MAIZE

the most effective means for their control (see, e.g., IPM, 2004 ; IPM, 2007 ; University of California, 2009 )

. Overreliance on a single weed management strategy, for example, a single MOA herbicide application, can cause intense s election pressure on weed populations

. In this context, selection pressure is the extent to which organisms possessing a particular characteristic are either eliminated or favored by environmental conditions ( Vencill et al., 2012 )

. This strong selection pressure can result in ecological shift s in the weed com munity or the evolution of herbicide

resistant biotypes ( Shaw et al., 2011 ; Wilson et al., 2011 ; Vencill et al., 2012 )

. Ecological shifts in the weed community may result in the selection of weeds that have an inherent resistance 19 to an herbicide MOA ; whereas the development of herbicide resistance 20 in a population usually relies on the appearance and maintenance of herbicide

- resistant alleles in a population ( Vencill et al., 2012 )

. The emergence of herbicide resistance is not limited to any one herbicide or production system ( Heap, 2012 )

. However, as described in S ubsection 2.2.2.3

– Agronomic Inputs, large

- scale adoption of GE h erbicide

- resistant corn varieties (e.g., glyphosate

- resistant corn) has resulted in changes in herbicide use patterns, culminating with the use of glyphosate as the primary means of weed control on the majority of U.S. cornfields. Tables 2

- 3 t hrough 2

- 5 li st those weedy species which have been identified as herbicide

- resistant to glyphosate , as well as glufosinate and atrazine , in at least some part of their range. These three herbicides are listed to illustrate the differences between glyphosate and atrazi ne , the two most commonly used corn herbicides, and glufosinate, a less commonly applied product to which some GE corn varieties (e.g., 1507, 59122, and 1507 x 59122 Maize) are resistant

. The emergence of herbicide resistance presents continued challenges to growers to understand which herbicide

- resistant species are present and the best agronomic practice available to manage the herbicide

- resistant weed.
Table 2

- 3
. U.S. glyphosate

- resistant (G/9) weeds through July 2012.
System Scientific Name Common Name Year Identified Weeds identified outside of Roundup Ready ® Systems Lolium rigidum Rigid Ryegrass 1998 Conyza bonariensis Hairy Fleabane 2003 Weeds identified in Roundup Ready ® Systems Poa annua Annual Bluegrass 2010 Kochia scoparia Kochia 2007 Ambrosia artemisiifolia Common Ragweed 2004 Ambrosia trifida Giant Ragweed 2004 Eleusine indica Goosegrass 2010 Conyza c anadensis Horseweed, Marestail 2000 Amaranthus palmeri Palmer Amaranth 2005 Amaranthus rudis Common Waterhemp 2005 Lolium multiflorum 1 Italian Ryegrass 2001 Echinochloa colona Junglerice 2008

19 In the context of weeds, tolerance is defined by the Weed Scie nce Society of America (WSSA) as, ‘‘the inherent ability of a species to survive and reproduce after herbicide treatment. This implies that there was no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant.’’ 20 In the cont ext of weeds, resistance is defined by the WSSA as, “ the inherited ability of a plant to survive and reproduce following exposure to a dose of herbicide normally lethal to the wild type.”
34DRAFT PIONEER 4114 MAIZE

System Scientific Name Common Name Year Identified Sorghum halepense Johnsongrass 2005 Source: ( Heap, 2012 ) As noted in Table 2

- 5 , Italian Ryegrass resistant to both gl yphosate and glufosinate has been identified in Oregon.

Table 2

- 4 . Photosystem II inhibitor

- resistant* (C/1) weeds through July 2012.

Scientific Name Common Name Year Identified Abutilon theophrasti Velvetleaf 1984 Amaranthus hybridus Smooth Pigweed 1972 Amaranthus palmeri Palmer Amaranth 1993 Amaranthus powellii Powell Amaranth 1977 Amaranthus retroflexus Redroot Pigweed 1980 Amaranthus tuberculatus (syn. rudis) Common Waterhemp 1994

Ambrosia artemisiifolia Common Ragweed 1976 Atriplex patula Spreading Orach 1980 Capsella bursa

- pastoris Shepherd's

- purse 1984 Chenopodium album Lambsquarters 1973 Chenopodium strictum var

. glaucophyllum Late Flowering Goosefoot 1976

Chloris inflate Swollen Fingergrass 1987 Conyza canadensis Horseweed 1981 Datura stramonium Jimsonweed 1992 Echinochloa crus

- galli Barnyardgrass 1978 Eleusine indica Goosegrass 2003 Kochia scoparia Kochia 1976 Poa annua Annual Bluegrass 1978 Polygonum pensylvanicum Pennsylvania Smartweed 1990 Polygonum persicaria Ladysthumb 1980 Portulaca oleracea Common Purslane 1991 Senecio vulgaris Common Groundsel 1970 Setaria faberi Giant Foxtail 1984 Setaria glauca Yellow Foxtail (glauca) 1981 Solanum ptycanthum Eastern Black Nightshade 2004 Source: ( Heap, 2012 ) *Atrazine is a photosystem II inhibitor.

Table 2

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

Scientific Name Common Name Year Identified Lolium multiflorum 2 Italian Ryegrass 2010 Source: ( Heap, 2012 ) Notes: 1. Glufosinate is a glutamine synthase inhibitor 2. Italian R yegrass also is resistant to glyphosate. In 2012, Heap notes that Italian Ryegrass was found in Oregon at 2 to 5 sites, between 51 and 100 acres, demonstrating multiple resistance.

35DRAFT PIONEER 4114 MAIZE

2.4.2.2 Corn as a Weed or Volunteer In the United States, corn is not listed as a weed ( Crockett, 1977 ; Muenscher, 1980 ) , nor is it present in the Federal Noxious Weed List (7 CFR Part 360 21 ) ( USDA

- NRCS, 2011a ; USDA

NRCS, 2012a ) . Furthermore, corn is grown throughout the world without any report that it is a serious weed or that it forms persistent feral populations ( Gould, 1968 ; OECD, 2003 ) , because corn possesses few of the characteristics of those plants that are notably successful as weeds ( Baker, 1965 ; Keeler, 1989 )

. However, corn seed from a previous year’s crop can overwinter and germinate the following year in a field , similar to other domesticated crops . Manual or chemical measures are often applied to remove these volunteers. The plants that are not removed do not typically result in feral populations in following years because maize is incapable of sustained reproduction outs ide of domestic cultivation ( Gould, 1968 )

. Corn periodically occurs as a volunteer when corn seeds remain in the field after harvest and successfully germinate ( Beckett and Stoller, 1988 ; USDA

- APHIS, 2012e ) (see also Davis, 2009 ; Hager, 2009 ; Bernards et al., 2010 ; Johnson et al., 2010 ; Wilson et al., 2010 ; Stewart, 2011 ; Wilson, 2011 )

. Post

- harvest seed residues in fields can be a result of harvester inefficiency, bir d dispersal or seed drop, with the seed ending up beyond the field margins or remaining as residues in the field after the harvest ( Davis, 2009 ) . This can be a particular problem when weather late in the season causes ears to drop or lodging to occur , which places the ears on the ground where the seed s then germinate the following year ( Wilson et al., 2010 )

. Volunteer corn can be present as single plants or as clumps formed when a n ear drops to the ground and is partially buried ( Davis, 2009 ; Wilson et al., 2010 )

. When those seeds survive to the subsequent growing season, volunteer plants may develop within subsequent crops or outside of the cropped area. The potential for corn , including GE corn , to establish as a volunteer has been the subject of recent research, with a particular emphasis on yield impact and management of herbicide

- resistant corn as a volunteer in subsequent crops modified for resistance to the same herbicide ( Beckett and Stoller, 1988 ; Beckie and Owen, 2007 ; Davis, 2009 ; Wilson et al., 2010 ; Wilson, 2011 )

. Corn volunteers are limited by the geography in which they initially are planted. Corn is an annual plant, and cannot survive temperatures below 0 °C for more than 6 to 8 hours when the growing point is above ground ; however, corn seeds which are incorporated in the soil during harvest or in fall tillage may overwinter and grow the following spring ( OECD, 2003 ; Stewart, 2011 )

. Volunteer corn la cks vigor and competitiveness because the volunteer plant is two generations removed from the cross which produced the hybrid planted ( Davis, 2009 )

. GE corn may be a problematic vo lunteer the year after harvest in field crops grown in rotation with corn, especially soybean, dry beans, sugar beets , as well as subsequent corn crops ( Davis, 2009 ; Hager, 2009 ; Bernards et al., 2010 ; Johnson et al., 2010 ; Wilson et al., 2010 ; Stewart, 2011 ; Wilson, 2011 )

. For example, the presence of volunteer corn in soybeans was identified in 12% of the soybean acreage in Illinois in a 2005 survey of soybean acreage in corn

– soybean rotation systems ( Davis, 2009 ) , and a 201 0 survey of soybean cultivation in Illinois identified a field with up to 500,000 volunteer corn plants per acre ( Hager, 2010 )

.

21 http://www.aphis.usda.gov/plant_health/plant_pest_info/weeds/downloads/weedlist

- 2010doc.pdf

36DRAFT PIONEER 4114 MAIZE

Volunteer corn competes with the intended crop for light, soil moisture, and nutrients ( Soltani et al., 2006 ; Bernards et al., 2010 ; Wilson et al., 2010 )

. The effect of volunteer corn on the yields of the intended crop depends on the density of the volunteer corn ( Davis, 2009 ; Bernards et al., 2010 ; Jeschke and Doerge, 2010 )

. In controlled agronomic studies, an analysis of yield impacts to soybeans from volunteer corn was evaluated at densities up to 17,800 corn plants per acre of soybean ( Alms et al., 2007 ; Alms et al., 2008 )

. In these controlled studies, volunteer corn densities ranging from zero plants per square meter up to 4.4 plants per square meter were cultivated in soybean, with corresponding soybean yield losses of up to 58% ( Alms et al., 2007 ; Alms et al., 2008 )

. Pre

- harvest herbicide treatments of the volunteer corn reduced but did not eliminate the yield impacts. In experimental studies, volunteer corn in soybeans was controlled using different application rates of the herbicide c lethodim i n the attempt to better quantify soybean yield loss ( Alms et al., 2008 )

. Clethodim treatments of the volunteer corn did reduce the volunteer corn density, alth ough even after a 98% control of the volunteer corn, soybean yield still suffered a 5% reduction in yield ( Alms et al., 2008 )

. Successful control of corn volun teers, including herbicide

- resistant varieties, is accomplished with the use of various combinations of cultivation practices and herbicides ( Beckett and Stoller, 1988 ; Beckie and Owen, 2007 ; Sandell et al., 2009 ; Jeschke and Doerge, 2010 )

. Volunteer corn is less of a conce rn in no

- till fields than in fall

- tilled fields because of the lower probability that corn seed will survive and germinate in the following growing season ( Bernards et al., 2010 )

. In
no
- till fields, the fallen corn is frequently eaten by wildlife and also is subject to winter weather conditions ( Bernards et al., 2010 )

. In fall tillage systems, corn seed may be buried in the soil and overwinter . V olunteer corn which h as emerged from this overwintered seed requires control with spring tillage or with an application of herbicides ( Bernards et al., 2010 )

. Volunteer corn also can be problematic in fields where the grower elect s to cultivate corn after corn. Such v olunteer corn in cornfields can be controlled using inter

- row cultivation and several different herbicides ( Minnesota, 2009 ; Sandell et al., 2009 )

. As noted with volunteer corn in soyb ean, growers can take advantage of alternate modes of herbicide action if the herbicide resistance differs between the current crop and the volunteer (e.g., glufosinate in LibertyLink ® Corn to control a glyphosate

- resistant variety) ( Minnesota, 2009 )

. Pre

- emergent controls might include Gramoxone Inteon (paraquat) mixed with Atrazine ( Sandell et al., 2009 ; Monsanto, 2010 )

. When these two herbicides are used together, optimal control is observed if the applications are made before the corn reaches the 6

- inch stage ( Monsanto, 2010 ) . If the volunteer corn is stacked to contain both a glyphosate

- and glufosinate

- resistant trait , int er
- row cultivation is the only option for post

- emergent control within corn ( Sandell et al., 2009 )

. 2.4.3 Soil Microorganisms Microorganisms in the field may mediate both negative and positive outcomes. Diseases that afflict corn with substantial potential for economic loss include fungal corn rusts, corn leaf blights, ear smuts, ear and kernel rot fungi, and maize mosaic viruses ( Cartwright et al., 2006 )

. M icroorganisms may also play an important role in the ecology of the soil ( OECD, 2003 )

. S oil microorganisms pla y a key and beneficial role in soil structure formation, decomposition of organic matter, toxin removal, nutrient cycling, and most biochemical soil processes ( Young and Ritz, 2000 ; Garbeva et al., 2004 )

. Microorganisms also may suppress soil

- borne plant diseases

37DRAFT PIONEER 4114 MAIZE

and promote plant growth ( Doran et al., 1996 )

. The main factors affecting microbial population size and diversity include soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient content), plan t type (providers of specific carbon and energy sources into the soil), and agricultural management practices (crop rotation, tillage, herbicide and fertilizer application, and irrigation) ( Young and Ritz, 2000 ; Garbeva et al., 2004 )

. Plant roots release a large variety of compounds into the soil , creating a unique environment for microorganisms in the rhizosphere 22 ( Bais et al., 2006 )

. Microbial diversity in the rhizosphere is extensive and differs from the microbial community in the bulk soil ( Garbeva et al., 2004 )

. 2.4.4 Biological Diversity
Biodive rsity refers to all plants, animals, and microorganisms interacting in an ecosystem ( Wilson, 1988 )

. Agricultural biodiversity has been defined to include genetic diversity of the crops through and including the natural biodiversity of the surrounding ecosystem ( see, e.g., Carpen ter, 2011 )

. USDA

- APHIS focuses its analysis of biological diversity at the ecosystem level, that aspect of the environment potentially impacted by the determination of nonregulated status of various GE crops. In this case, biodiversity refers to the abi lity of a highly managed ecosystem, such as a cornfield, to support species that do not contribute directly to crop production but represent important components of the biological landscape. Such species include those affecting pollination (e.g., bees, butterflies) and control of insect pests ; important avian (e.g., songbirds) and mammalian (e.g., small mammals) wildlife ; and the plant community. Among other benefits, natural biodiversity provides valuable genetic res ources for crop improvement ( Ha rlan, 1975 ) and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservatio n, disease suppression, control of local microclimate, control of local hydrological processes, and detoxification of noxious chemicals ( Altieri, 2000 )

. Beneficial insects, birds, and mammals are natural predators of many crop pests and play an important role in pest management ( USDA

NRCS, 2002 )

. The loss of biodiversity results in a need for costly external input s in order to provide these functions to the crop ( Altier i, 1999 ; Altieri, 2000 )

. Species diversity and abundance in corn agro

- ecosystems may differ among conventional, GE, and organic production systems. Relative to any natural ecosystem, species abundance and richness will generally be less in intensively managed agro

- ecosystems. The degree of biodiversity in an agro

- ecosystem depends on four primary characteristics: 1) diversity of vegetation within and around the agro

- ecosystem; 2) permanence of various crops within the system; 3) intensity of ecosystem management; and 4) extent of isolation of the agro

- ecosystem from natural areas of native vegetation ( Altieri, 1999 ; USDA

- NRCS, 2002 )

. Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest limit habitat diversity resulting in a corresponding decrease in diversity of plants and animals.

22 The r hizosphere is defined as subsoil area in the root zone of plants in which plant roots compete with the invading ro ot systems of neighboring plants for space, water, and mineral nutrients, and interact with soil

- borne microorganisms, including bacteria, fungi, and insects feeding on the organic material in the soil T. S. Walker, H. P. Bais, E. Grotewold and J. M. Vivanco, "Root Exudation and Rhizosphere Biology," Plant physiology 132.1 (2003).

. 38DRAFT PIONEER 4114 MAIZE

Cropland management practices, including a range of practices incorporated in integrated pest management plans can be adopted which increase habitat preservation and plant biodiversity (see, e.g., IPM, 2004 ; IPM, 2007 ; Sharpe, 2010 ; Palmer et al., 2011 )

. Conservation tillage and no

- till practices have a positive impact on wildlife, including the community of beneficial arthropods ( Altieri, 1999 ; Landis et al., 2005 ; Towery and Werblow, 2010 )

. These b enefits derive from decreased soil erosion and improved water quality in receiving waters, retention of cover, availability of waste grain on the soil surface for feed, and increased populations of predaceous invertebra tes as well as invertebrates as a food source ( Landis et al., 2005 ; Sharpe, 2010 )

. Crop rotations reduce the likelihood of crop disease, insect pests, weed pests, and the need for pesticides ( Randall et al., 2002 )

. Reduced pesticide use has a direct positive effect on wildlife by reducing the direct exposure of birds, mammals, and fish to pesticides. Indirect benefits include less alteration of sui table wildlife habitat and an available food supply of insects for insectivores ( Sharpe, 2010 ; Palmer et al., 2011 )

. Crop rotations with legumes and small grains have been shown to provide excellent wildlife nesting cover, food, a nd brood

- rearing habitat ( Sharpe, 2010 )

. Polycultures of plants support herbivorous insect populations because they provide a more stable and continuous availability of food and habitat for beneficial insects ( Altieri and Letourneau, 1982 ; Altieri and Letourneau, 1984 ; Altieri, 1999 ; Landis et al., 2005 )

. Field edges can be managed to promote wildlife. These borders are often the least productive areas in a farm field and in some cases, the cost of producing crop areas along field edges exceeds the value of the crop produced ( Sharpe, 2010 )

. Allowing field edges to return to non
crop vegetation does contribute to weed seeds in the field, but does not contribute to major pest problems in the crop field itself ( Sharpe, 2010 )

. Non

- crop border vegetation, such as ragweed, goldenrod, asters, and forbs, may quickly develop into nesting and brood habitat for quail and a multitude of songbirds ( Sharpe, 2010 )

. Maintaining some weeds harbors and supports beneficial arthropods that suppress herbivore insect pests ( Altieri and Letourneau, 1982 ; Altieri and Letourneau, 1984 ; Altieri, 1999 )

. Research conducted at North Carolina State University and the North Carolina Wildlife Resources Commission found that fields with bands of natural cover along ditch bank s have more quail and wintering so ngb irds than nearby fields with closely mowed ditch banks ( Sharpe, 2010 )

. Adjacent wild vegetation provides alternate food and habitat for natural enemies to pest herbivores ( Altieri and Letourneau, 1982 ; Altieri and Letourneau, 1984 ; Altieri, 1999 )

. Contour

- strip cropping is another management practice that can be used to pr omote wildlife habitat. This practice alternates strips of row crops with strips of solid stand crops (i.e., grasses, legumes, or small grains) with the strips following the contour of the land ( Sharpe, 2010 )

. The primary purpose of contour

- strip cropping is to reduce soil erosi on and water runoff, but the solid stand crop also provides nesting and roosting cover for wildlife ( Sharpe, 2010 ) . Grass

- legume refuge strips also have been used to increase the population density of insectivorous carabid beetles in corn and soybean fields ( Landis et al., 2005 )

. Drainage ditches, hedgerows, riparian areas, and adjacent woodlands to a cornfield also provide cover, nesting sites, and forage areas, which each contribute to enhancing wildlife populations. Ditch banks, for example, function as narrow wetlands that provide nesting sites and cover, serve

39DRAFT PIONEER 4114 MAIZE

as wildlife corridors, and provide areas for the wildlife to occupy when crop fields lack cover ( Sharpe, 2010 )

. Ditches have been shown to support birds, rodents, reptiles, furbeare rs, amphibians, fish, and aquatic organisms ( Sharpe, 2010 )

. 2.4.5 Gene Movement
2.4.5.1 Vertical Gene Movement Vertical gene movement (i.e., vertical gene flow or sexual reproduction) generally involves the movement of alleles from parents to offspring. In corn, sexual reproduction may occur between domesticated corn varieties or from corn to sexually

- compatible relatives. Vertical g ene flow include s the possibility of pollen transfer between different varieties of corn. A variety of plant properties, environmental conditions, and imposed con ditions can affect movement of genes between co rn cultivars. F or gene flow to occur between corn varieties, viable pollen must reach a receptive tassel ( Lerner and Dana, 2001 ) . This requires that flowering times must overlap, viable pollen transfer between the varieties must occur, embryo/seeds must develop, and hybrid seed must disperse and establish (see, e.g., Lerner and Dana, 2001 ; Diver et al., 2008 )

. Spatial and temporal isolation can be one of the most effective barriers t o gene exchange between co rn crop cultivars ( Mallory

- Smith and Zapiola, 2008 ) . Current practices for maintaining the purity of hybrid seed production in corn are typically successful for maintaining 99% genetic purity, though higher instances of out

- crossing can occur ( Ireland et al., 2006 )

. These practices for maintaining varietal purity are also discussed in Subsection 2.2. 3

– O rganic C orn Farming and S pecialty C orn Systems

. The possibility of gene movement from the host plant into native or feral populations of Zea species or wild or weedy relatives of corn has been evaluated by the US

- EPA and determined to not be a concern in the continental United States ( US

- EPA, 2010e )

. The potentia l for outcrossing is defined as the likelihood of gene movement to wild corn relatives. This subsection provides a basis for evaluating the potential for outcrossing in corn to these wild corn varieties.
The closest relative of Zea is the genus Tripsacum ( OECD, 2003 )

. Seventeen species of Tripsacum have been identified, with chromosome number varying from 2n = 36 to 2n = 108 ( OECD, 2003 )

. All of the Tripsacum species are perennial and are mostly found in Central America 23 ( OECD, 2003 )

. However, t hree species have been identified in the United States: T. dactyloides , Eastern gamagrass, is known to occur in the eastern half of the United States , T. lanceolatum , Mexican gamagrass, occurs in the southwest of the United States , and T. floridanum , Florida gamagrass, is native to South Florida and Cuba ( Wozniak, 2002 ; OECD, 2003 )

. T. dactyloides is the only Tripsacum species of widespread occurr ence and agricultural importance in the United States , and commonly is grown as a forage grass ( Wozniak, 2002 )

. Distinctions in genetic construct between related species are important to recogni ze, as the genetic differences directly affect the ability of cultivated corn to interbreed with wild relatives.

23 For example, Tripsacum may be found in C entral Mexico, Belize, Guatemala, El Salvador, Honduras, Nicaragua and Costa Rica.

40DRAFT PIONEER 4114 MAIZE

Tripsacum differs from corn in many respects, including chromosome number ( T. dactyloides n = 18; Z. mays n = 10) ( Wozniak, 2002 )

. The three Tripsacum species in the United States exhibit several ploidy types. T. floridanum has a diploid chromosome number of 2n = 36 ( Wozniak, 20 02 )

. T. dactyloides includes 2n = 36 forms which are native to the central and western United States , and 2n = 72 forms which extend along the Eastern seaboard and along the Gulf Coast from Florida to Texas, but which also have been found in Illinois an d Kansas ( Wozniak, 2002 )

. T. lanceolatum has a diploid number 2n = 72 ( Wozniak, 2002 )

. The potential for pollen

- directed gene flow fro m maize to Eastern gamagrass is remote ( Wozniak, 2002 )

. Although hybridization of Tripsa cum x Z. mays has been accomplished in the laboratory using special techniques under highly controlled conditions , these hybrids have not been observed in the field ( Wozniak, 2002 )

. Additionally, Trips a cum do es not represent any species considered a serious or pernicious weed in the United States or its territories ( Wozniak, 2002 )

. Any introgression of corn genes into this species as a result of cros s fertilization is not expected to result in a species that is weedy or difficult to control ( Wozniak, 2002 )

. Hybrids between Z. mays and the teosinte subspecies Z. mays subsp. mexicana are known to occur when the two are sympatric in Mexico ( CEC, 2004 ; Ellstrand et al., 2007a )

. Many species of Tripsacum can cross with Zea , or at least some accessions of each species can cross, but only with difficulty and the resulting hybrids are primarily male and female sterile ( Wozniak, 2002 )

. The rate at which crop genes enter teosinte populations may be limited by genetic barriers, phenological differences, and subsequently by the relative fitness of the hybrids ( CEC, 2004 ; Ellstrand et al., 2007a )

. 2.4.5.2 Horizontal Gene Movement Horizontal gene movement (i.e., hori zontal gene transfer) and consequent expression of deoxyribonucleic acid ( DNA ) from a plant species to bacteria , is unlikely to occur ( Keese, 2008 )

. Many bacteria (or parts thereof) that are closely associated with plants have been sequenced, including Agrobacterium and Rhizobium ( Kaneko et al., 2000 ; Wood et al., 2001 ; Kaneko et al., 2002 )

. There is no evidence that these organisms contain genes derived from plants. In cases where the review of sequence data im plied that horizontal gene transfer occurred, these events were inferred to occur on an evolutionary time scale on the order of millions of years ( Brown, 2003 )

. 2.5 PUBL IC HEALTH
2.5.1 Human Health Since 1980, the public’s consumption of corn

- based products has more than doubled. Per capita consumption of corn products rose from 12.9 pounds annually per capita in 1980 to 33 pounds in 2008; and corn sweeteners increased from 35.3 pounds annually per c apita to 69.2 pounds during that period ( USCB, 2011 ) . As of 2012, 88% of the corn cultivated is GE ( USDA

- NASS, 2 012c )

. Human health concerns associated with the use of GE corn generally focus on human consumption of GE corn and products derived from GE corn . This subsection provides a summary of the principal human health concerns related to the consumption of GE corn

. I ssues related to farm workers or animal feed are presented in S ubsection 2.5.2

– Worker S afety and S ubsection 2.6

– Animal Feed , respectively

.

41DRAFT PIONEER 4114 MAIZE

P otential public health concerns from GE crops may result from two aspects of the crop: the use of pesti cides on a crop and the potential changes in crop composition 24 , including exposure to the introduced genes/proteins

. In general, members of the general public may be exposed to pesticides and pesticide residues through consumption of agricultural crops. Before a pesticide can be used on a food crop, US

EPA , pursuant to the FFDCA, must establish a tolerance value represent ing the maximum pesticide residue that may remain on the crop or in foods processed from that crop ( 21 U.S.C. §301, et seq. ; se e also http://www.epa.gov/opp00001/regulating/tolerances.htm )

. Pesticide tolerances established by the US

- EPA ensure safety of foods treated with pesticides and are made following risk assessments that reflect real

- world consumer exposure as closely as possible ( US

- EPA, 2012e )

. These tolerances include traditional pesticides, such as herbicides, and genetic elements that may be introduced through GE processes, such as PIPs (e.g., Cry proteins) or proteins that confer herbicide resistance (e.g., PAT) ( US

- EPA, 2007a )

. Common corn herbicides and PIPs that are currently used in U.S. corn production are listed and discussed in Subsection 2.2

– Agricultural Production of Corn. T he US

- FDA and the USDA monitor foods for pesticide residues and work with the US

- EPA to enforce these tolerances ( see USDA

- AMS, 2011 )

. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and labeled properly. GE organisms for food and feed may undergo a voluntary consultation process with the US

- FDA prior to release onto the market. Although a voluntary process, thus far, all applicants who have wished to commercialize a GE crop variety that would be included in the food supply have completed a consultation with the US

- FDA . In such a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to US

- FDA a summary of its scientific and regulatory assessment of the food. This process includes: 1) an evaluation of the amino acid sequence introduced into the food crop to confirm whether the p rotein is related to known toxins and allergens; 2) an assessment of the protein’s potential for digestion; and 3) an evaluation of the history of safe use of the protein in food ( Hammond and Jez, 2011 )

. US

- FDA evaluates the submission and responds to the developer by letter with any concerns it may have or additional information it may require. Several international agencies also review food safety associated with GE

- deri ved food items, including the EFSA and the Australia and New Zealand Food Standards Agency (ANZFS). Additionally, foods derived from biotechnology also undergo a comprehensive safety evaluation before entering the market, including reviews under the CODEX, the European Food Safety Agency, and the World Health Organization ( FAO, 2009 ; Hammond and Jez, 2011 ) . Food safe ty reviews frequently will compare the compositional characteristics of the GE crop with non

transgenic, conventional varieties of that crop ( see also Aumaitre et al., 2002 ; FAO, 2009 )

. Moreover, this comparison also evaluates the composition of the modified crop under actual

24 As determined by the OECD Consensus Document on Compositional Considerations for New Varieties of Maize ( Zea mays ): Key Food and Feed Nutrients, Anti

- Nutrients and Seconda ry Plant Metabolites. http://www.oecd.org/science/biosafety

- biotrack/46815196.pdf

. Last accessed August 27, 2012.

42DRAFT PIONEER 4114 MAIZE

agronomic conditions, including various agronomic inputs ( see, e.g., Pioneer Petition, , 2011b )

. Composition characteristics evaluated in these comparative tests include moisture, protein, fat, carbohydrates, ash , minerals, dietary fiber, essential and non

- essential amino acids, fatty acids, vitamins, and anti

- nutrients ( OECD, 2002 ; Pioneer, 2011 b )

. Comparison of anti

- nutrients represents an important element of this comparison. Anti

- nutrients are naturally

- occurring compounds produced by a plant which interfere with the absorption and metabolism of the consumed crop as well as other foods in the digestive tract ( Cordain, 1999 )

. Anti

- nutrients in corn include raffinose, phytic acid and trypsin inhibitor ( OECD, 2002 )

. Raffinose is a low molecular weight oligosaccharide that is non

- digestible, causing flatulence from consumption ( OECD, 2002 ) . Phytic ac id chelates mineral nutrients rendering them unavailable to monogastric animals ( OECD, 2002 ; Pioneer, 2011b ) . Trypsin inhibitors inhi bit protein digestion ( Cordain, 1999 )

. As noted by the National Research Council (NRC), unexpected and unintended compositional changes arise with all forms of genetic modification, including both conventional hybridizing and GE ( NRC, 2004 ) . The NRC also noted in its 2004 report that no adverse human health effects attributed to GE had been documented. More re cently, the NRC found that the cultivation of GE crops has resulted in improvements of pesticide application regimens (applications of fewer pesticides or using pesticides with lower environmental toxicity), and that the cultivation of herbicide

- resistant crops was advantageous because of their efficacy in pest control and concomitant economic, environmental, and presumed personal health advantages ( NRC, 2010 )

. Reviews on the nutritional quality of GE f oods generally have generally concluded that there are no biologically meaningful nutritional differences between conventional and GE plants for food or animal feed ( Aumaitre et al., 2002 ; Faust, 2004 ; Van Deynze et al., 2004 )

. The nutritional content of corn may also be affected by corn pests and diseases. For example, mycotoxins are chemicals that are produced by fungi and that are toxic or carcinogenic to animals and humans ( US

- EPA, 2010b ) . The most common my cotoxin in corn is the class of compounds called fumonisins, produced as a result of infections by the fungal genus Fusarium ( Munkvold and Hellmich, 2000 ; US

- EPA, 2010b ) . Another class of mycotoxins in corn is the aflatoxins, produced by the genus Aspergillus ( Munkvold and Hellmich, 1999 ) . Injury by insect pests can be an important factor in mycotoxin development in corn. Insect pests promote the growth of mycotoxin

- producing fungi by creati ng entry wounds on the kernels and carrying fungal spores from the plant surface to damaged kernels ( Munkvold and Hellmich, 1999 ; Munkvold and Hellmich, 2000 ) . By reducing insect predati on and kernel damage, the incorporation of Bt in corn has been shown to reduce contamination by the mycotoxin fumonisin ( Munkvold and Hellmich, 1999 )

. 2.5.2 Worker Safety Worker hazards in farming are common to all types of agricultural production, and include hazards of machinery and common agricultural management practices. A common agricultural practice, p esticide application , represents the primary exposure route to pesticides for farm workers. Pesticides, including herbicides, are used on most corn acreage in the United States ( Pioneer, 2012 )

. Changes in acreage, crops, or farming practices may affect the amounts and types of pesticides used, and thus, the risks to workers.

43DRAFT PIONEER 4114 MAIZE

As discussed in Subsection 1.3

– Coordinated Framework Review and Regulatory Review, all pesticides labeled for use on crops in the United States must first be registered by the US

- EPA

. Among other elements, t he US

- EPA pesticide registration process involves the design of use restrictions that, when followed, have been determined to be protective of worker health. Worker safety precautions and use restrictions are noted clearly on pesticide registration labels. These restrictions provide instructions as to the appropriate levels of personal protection required for agricultural workers to use herbicides. These may include instructions on personal protective equipment, specific handling requirements, and field reentry procedures ( Bayer, 2012 )

. When used in accordance with the label, one corn herbicide, glufosinate , has been determined to not present a health risk to workers ( US

- EPA, 2008b )

. EPA’s Worker Pro tection Standard (WPS) (40 CFR Part 170) was published in 1992 to require actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS offers protections to more than two and a half million agri cultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipme nt, restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance.
2.6 ANIMAL FEED Corn comprises more than 95 % of the total U.S. feed grain production ( USDA

- ERS, 2012d )

. Corn is valuable as a feed because of its composition, including key nutrients and secondary metabolites, protein content, fiber, among others ( OECD, 2002 ) . Corn grain is used for feed for beef cattle, poultry, hogs and dairy cattle , with beef cattle consuming the largest volume harvested ( NCGA, 2009 ) . Animal feed derived from corn comes not only from the unprocessed grai n, but also from silage, the above

- ground portions of the corn plant, and stalk residues in fields that might be grazed ( OECD, 2002 ) . Processed product r esiduals derived from additional major corn industries such as corn refining, corn dry millers, and distillers also are used as animal feed ( CRA, 2006 ) . Animal feed products from corn refining and wet milling include corn gluten feed, corn gluten meal, corn germ meal, corn steep liquor, and amino acids ( CRA, 2006 )

. In addition to direct feeding of corn grain, many corn

- based animal feed pr oducts are derived from other processes involving chemical or mechanical processing. For example, corn gluten feed is the residue remaining after the extraction of starch, gluten, and germ ( CRA, 2006 ) . Corn gluten feed is considered a medium protein product and is used widely in complete animal feeds for dairy and beef cattle, poultry, and hog s ( CRA, 2006 ) . Corn gluten meal is a high

- protein ingredient consisting of corn proteins separated in the milling process, and may contain as much as 60% protein ( CRA, 2006 ) . The high protein content also is valued as a cattle feed to protect the cow’s rumen ( CRA, 2006 ) . Corn germ meal is a residual product obtained from the corn germ after the corn oil has been extracted ( CRA, 2006 ) . Corn germ meal is a small fraction of the corn kernel, and has a small market in animal feed as a carrier for liquid nutrients ( CRA, 2006 )

. Corn steep liquor is a high protein product comprised of the soluble portions of the corn kernel removed during the corn steep process ( CRA, 2006 ) . Corn steep liquor is sometimes combined with other ingredients in corn gluten feed or provided as a liquid pr otein source ( CRA, 2006 )

. Amino acids are produced through the fermentation of corn

- deriv ed dextrose ( CRA, 2006 )

.
44DRAFT PIONEER 4114 MAIZE

Lysine, an essential animal amino acid, is a highly valued corn

- derived amino acid for both poultry and swine ( CRA, 2006 ) . Threonine and tryptophan amino acid feed supplements also are produced from corn ( CRA, 2006 )

. Public concern for animal feed and GE crops generally relates to two aspects of the crop: the use of a pesticide on the crop; and the potential changes in crop composition , including genes or proteins associated with the introduced trait. For pesticides and pesticide residues, US

- EPA generally establishes animal feed tolerances at the same time as the tolerances for food ( http://www.epa.gov/pesticides/bluebook/chapter11.html )

. Similar to tolerance values for f ood, these US

- EPA tolerance values for feed are set to ensure safety of raw or processed commodities for animal feed and may include conventional pesticides (e.g., herbicides) and genetic elements resulting from genetic engineering, such as PIPs (e.g., Cry proteins) or proteins conferring herbicide resistance (e.g., PAT protein) ( US

- EPA, 2012e )

. 2.7 SOCIOECONOMIC Corn is produced for food and feed commodities as well as industrial uses ( USDA

- ERS, 2012d )

. Corn is the most widely cultivated feed grain in the United States, accounting for more than 95% of total value and production of feed grains ( James, 2009 ; USDA

- ERS, 2011d ; USDA

- ERS, 2012d ) . Corn is grown in a ll 48 states of the continental United States , with production concentrated in the Corn Belt

. The U.S. Corn Belt is loosely defined as the states of Illinois, Iowa, Indiana, the eastern portions of South Dakota and Nebraska, western Kentucky and Ohio, and the northern two

- thirds of Missouri. Iowa and Illinois are the two top corn producing states and typically account for more than one

- third of the total U.S. crop ( USDA

- ERS, 2012d ; USDA

NASS, 2012b )

. 2.7.1 Domestic Economic Environment In the 2012 production year, corn was cultivated in the United States on over 96 million acres, a 5% increase in corn acreage from 2011 ( USDA

- NASS, 2012b ) . Corn production in 2011 was estimated at 12.44 billion bushels and valued at an estimated $5.15 to $5.65 per bushel . This resulted in a total value of approximately $64.1

– 70.3 billion for 2011 . In 2012, production was estimated at 12.38 billion bushels ( USDA

- NASS, 2012c ) . However, because of severe drought throughout the Corn Belt, the estimates for corn production in 2012 were projected sharply lower. In August, 2012, the season average farm price f or corn was projected at $7.50 to $8.90 per bushel, a 39% increase in price from the previous month and a 58% average increase over 2011 ( USDA

- OCE, 2012b )

. The cultivat ion of corn for animal feed varies depending upon the demand in the livestock industry ( USDA

- ERS, 2012d ) . Direct feeding of corn to livestock has declined in response to declines in meat production since 2007 in the United States, as has the use of certain corn by

products for livestock feeds ( USDA

- OCE, 2012b ) . The production of ethanol generates several economically valuable co

- products for animal feed , including distillers dried grains with solubles (DDGs) ( USDA

- ERS, 2012d ) . Each 56

- pound bushel of corn used in dry mill ethanol production generates approximat ely 17.4 pounds of DDGs which are fed to livestock ( USDA

- ERS, 2011d )

. Food and industrial use of corn (other than for ethanol production) is projected to increase, although this demand also is related to specific products ( USDA

- OCE, 2012b ) . Demand for

45DRAFT PIONEER 4114 MAIZE

high

- fructose corn syrup (HFCS), glucose and dextrose is expected to increase, but at lower rates than in previous years. Corn starch is considered an industrial product, the production of which is contingent on industrial demand ( USDA

- OCE, 2011 ; USDA

- OCE, 2012b )

. Gross value of production on a typical U.S. corn farm in 2011 was approximately $837/acre ( USDA

- ERS, 2012b )

. However, this does not take into associated production costs, suc h as operating cost s an d allocated overhead costs. In general, operating costs represented 40% ($332/acre) of corn farm gross income and may include expenses related to seed purchases, agronomic inputs (e.g., fertilizers, irrigation, and pesticides), and the maintenance of farm equipment. Allocated overhead costs, on the other hand, represented approximately 34% ($284/acre) of corn farm gross income and include expenses related to labor, acquisition of farming equipment, land rental rates , taxes, and insurance premiums . In total, net profit of a typical U.S. corn farm, minus operating and overhead costs, was $221/acre in 2011 ( USDA

- ERS, 2012b )

. The costs for GE corn seed are higher than that for non

- GE seed. Growers pay a premium for GE seed, with growers in 2008 paying as much as 50% more for GE corn seed than conventional seed ( NRC, 2010 ) . This seed premium includes a technology fee for the cultivation of the seed ( NRC, 2010 )

. This seed premium also reflects the in creased value offered by the seed. For example, a consumer buying a corn variety containing a Cry protein (e.g., 1507, 59122, or 1507 x 59122 Maize) is purchasing both the corn seed and an insecticide combined in a single product ( NRC, 2010 )

. D espite the increased cost of GE corn seed, total farm operating costs are often offset by improved grain yield and reduced corn production costs. These production cost reductions may be a result of increased yields, reductions in average herbicide and pest icide use per field, and corresponding reductions in tillage and associated field cultivation costs ( Carpenter et al., 2002 )

. Fuels and chemicals are each estimated to comprise approximately 5% of farm production expenses ( USDA

- NASS, 2009 )

. Other benefits to the grower from adoption of GE corn have included ( Carpenter et al., 2002 ; Brookes and Barfoot, 2010 ) :

• Increased management flexibility and convenience arising from the ease of use of broad

spectrum herbicides like glyphosate;

• A decrease in “knock

- back” of the crop associated with post

- emergent applicat ions of herbicides on the herbicide

- resistant crop;

• Reduced harvesting costs;

• Higher quality harvested crop;

• An improvement in soil quality as growers reduce quantities of soil

- applied herbicides and increase limited tillage; and

• Overall improvements in human health costs associated with use of less toxic products.
Herbicide

- resistant corn has been cultivated commercially since 1997. The cultivation of this crop has reduced costs and increase d profitability, with average grower profitability improved by $ 20/hectare to $25/hectare in most years when compared with the costs of conventional herbicide treatment used to gain the same level of control in a low/reduced till system ( Brookes and Barfoot, 2010 ) . These economic benefits are influenced by the comparative cost of the herbici des. For example, in 2007, the manufacturers of glyphosate posted a substantial increase

46DRAFT PIONEER 4114 MAIZE

in price, resulting in reduced average profitability of $ 17.60/hectare ( Brookes and Barfoot, 2010 )

. The primary economic benefit of the adoption of Bt corn derives from the avoidance of pesticide applications and the associated increase in yield (see, e.g., Fernandez

- Cornejo and Caswell, 2006 ; Brookes and Barfoot, 2012 )

. Cost savings to the grower include less time spent scouting the crop for pests and saving s in machinery use ( Brookes and Barfoot, 2012 )

. T he incorporation of Bt in corn has a secondary economic benefit to growers by reducing contamination by mycotoxins. Co r n that contains mycotoxins above a certain level is mo re likely to be rejected in the market, forcing growers to accept the lower price for non

- food uses ( US

EPA, 2010b )

. The costs of mycotoxins in the United States commodity market have been estimated as high as $5 billion/year ( Schmale III and Munkvold, 2012 )

. The emergence of glyphosate

- resistant weed biotypes has been identified as an economic
concern ( NRC, 2010 ) . Glyphosate resistance has been demonstrated to reduce the effectiveness and economic benefits of glyphosate

- resistant crop systems ( Weirich et al., 2011 )

. To manage these resistant weeds, growers generally increased herbicide application rates, increased the number of herbicide applications, and returned to more traditional tillage practices. Economic impacts of glyphosate

- resistant weeds are a direct result of increased inputs: additional herbicides are required to control the resistant weeds; fuel costs increase as heavy equipment is used more frequentl y in the field for chemical application and tillage; and tillage, labor, and management hours increase in association with the application of additional herbicides and machinery use ( NRC, 2010 ; Weirich et al., 2011 )

. There also is an additional cost from the reduction in yield associated with the competition of the crop and the glyphosate

- resistant weeds ( NRC, 2010 ; Weirich et al., 2011 )

. 2.7.2 Trade Economic Environment Corn is the dominant feed grain traded internationally ( James, 2009 ; USDA

- OCE, 2011 ; USDA

OCE, 201 2a ; USDA

- OCE, 2012b ; USDA

- OCE, 2012c ) . In 2011/2012, the United States produced approximately 36% of the total world supply of corn ( USDA

- OCE, 2012b )

. Corn is cultivated worldwide, including Argentina, South Africa, Brazil, Canada, China, and former Soviet Union States, including the Ukraine ( USDA

- O CE, 2012a )

. As the global demand for meat increases along with the commercialization of livestock feeding, international trade in livestock feed and protein meal supplements also increases, particularly in those countries where climate and geography re strict local production of these feed materials ( USDA

- FAS, 2012 ; USDA

- OCE, 2012a ) . Egypt, the EU, Japan, Mexico, Southeast Asia, and South Korea are net importers of corn ( USDA

- OCE, 2012b )

. Approximately 15 to 20% of U.S. corn production is exported, with the volume of exports projected to decrease in the next several years in the face of increased competition from lower

- priced South American supplies ( USDA

OCE, 2012b )

. China is projected to become a net importer of corn to support its expanding livestock and industrial sectors ( James, 2009 ; USDA

- OCE, 2011 ; USDA

- OCE, 2012a ; USDA

OCE, 2012b ) . The increase in China’ s imports are expected to account for one

- third of the growth in world corn trade ( USDA

- OCE, 2012b ) . In addition to corn as grain, c orn gluten feed is

47DRAFT PIONEER 4114 MAIZE

a major product in international trade in feed ingredients. Large volumes of U.S. corn gluten feed are exported to the EU ( CRA, 2006 )

. Identity protection is important in international trade. Some countries are sensitive to the importation of GE crops, and some have yet to approve importation of GE corn varieties ( see, e.g., ICTSD, 2005 )

. For certain key export markets, such as Canada, Japan, Mexico, Taiwan, South Korea and China, developers will prepare regulatory submissions prior to the commercial launch of the product ( Pioneer, 2011b )

. Specific end uses also may require identity protection throughout the export supply chain. For example, value enhanced specialty high

- oil corn is an important part of the U.S. export market as a replacement for animal f ats in feed rations ( USDA

FAS, 2004 )

. Identity protection (a s discussed in Subsec tion 2.2.3

– Organic Corn Farming and Specialty Corn Systems ) in international commodity movement increases the costs, as well as the premiums paid ( USDA

- FAS, 2004 )

.

48DRAFT PIONEER 4114 MAIZE



### 3 ALTERNATIVES This document analyzes the potential environmental consequences resulting from a determination of nonregulated status of Pioneer 4114 Maize . To respond favorably to a petition for nonregulated status, USDA

- APHIS must determine that Pioneer 4114 Maize is unlikely to pose a plant pest risk. Based on its PPRA ( USDA

- APHIS, 2012e ) , USDA

- APHIS has concluded that Pioneer 4114 Maize is unlikely to pose a plant pest risk. Therefore, USDA

- APHIS must d etermine that Pioneer 4114 Maize is no longer subject to 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

. Two alternatives will be evaluated in this EA: 1) no action; and 2) determination of nonregulated status of Pioneer 4114 Maize

. USDA

- APHIS has assessed the potential for environmental impacts for each alternative in Section 4 of this EA, Environmental Consequences.
Pioneer has indicated its intention to limit the cultivation of Pioneer 4114 Maize to use as a fo undation stock for developing stacked hybrids through conventional breeding techniques ( Pioneer, 2011b )

. In this process, the herbicide or insect resistance or other trait( s) in Pioneer 4114 Maize would be combined with the traits from other corn crop varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

. USDA

- APHIS does not have jurisdiction under the Plant Protection Act of 2000 and Part 340 to review such stacked hybrids developed using nonregulated articles and conventional hybridization techniques where there is no evidence of a plant pest risk. Accordingly, this EA focuses o n the cultivation of Pioneer 4114 Maize

. Issues associated with potential future stacking are presented and discussed in the cumulative impact s analyses (see Section 5

– Cumulative Impacts ), where appropriate.
3.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE
Under the No Action Alternative, USDA

- APHIS would deny the petition. Pioneer 4114 Maize and progeny derived from Pioneer 4114 Maize would continue to be regulated articles under the regulations at 7 CFR Part 340. Permits issued or notifications ack nowledged by USDA

- APHIS would still be required for introductions of Pioneer 4114 Maize and measures to ensure physical and reproductive confinement would continue to be implemented. USDA

- APHIS might choose this alternative if there were insufficient evide nce to demonstrate the lack of plant pest risk from the unconfined cultivation of Pioneer 4114 Maize

. This alternative is not the Preferred Alternative because USDA

- APHIS has concluded through a PPRA that Pioneer 4114 Maize is unlikely to pose a plant pes t risk ( USDA

- APHIS, 2012e )

. Choosing this alternative would not satisfy the purpose and need of making a determination of plant pest risk status and responding to the petition for nonregulated status

. 3.2 PREFERRED ALTERNATIVE: DETERMINATION THAT PI ONEER 4114 MAIZE IS NO LONGER A REGULATED ARTICLE Under this alternative, Pioneer 4114 Maize and progeny derived from them would no longer be regulated articles under the regulations at 7 CFR Part 340. Pioneer 4114 Maize is unlikely to pose a plant pest risk ( USDA

- APHIS, 2012e )

. Permits issued or notifications acknowledged by

49DRAFT PIONEER 4114 MAIZE

USDA

- APHIS would no longer be required for introductions of Pioneer 4114 Maize and progeny derived from this event.
This alternative bes t meets the purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR Part 340 and the agency’s authority under the plant pest provisions of the Plant Protection Act of 2000 . Because the agency has
c oncluded that Pioneer 4114 Maize is unlikely to pose a plant pest risk, a determination of nonregulated status of Pioneer 4114 Maize is a response that is consistent with the plant pest provisions of the Plant Protection Act of 2000 , the regulations codifi ed in 7 CFR Part 340, and the biotechnology regulatory policies in the Coordinated Framework. Under this alternative, growers may have future access to Pioneer 4114 Maize and progeny derived from this event if the developer decides to commercialize Pionee r 4114 Maize for use in breeding programs . In addition, growers and o t her parties that are involved in production, handling, processing, or consumption of corn would continue to be able to use the current corn products developed by conventional breeding as well as the GE corn variety. By granting nonregulated status to Pioneer 4114 Maize, the purpose and need to allow the safe development and use of GE organisms is met.
3.3 ALTERNATIVES CONSIDERED BUT REJECTED FRO M FURTHER CONSIDERATION
USDA

- APHIS assembled a comprehensive list of alternatives that might be considered for Pioneer 4114 Maize

. USDA

- APHIS evaluated these alternatives in light of the agency's authority under the plant pest provisions of the Plant Protection Act of 2000 , and the regulations at 7 CFR Part 340, with respect to environmental safety, efficacy, and practicality to identify which alternatives would be further considered for Pioneer 4114 Maize

. Based on this evaluation, USDA

- APHIS rejected several alternatives. These alternatives are discussed briefly below along with the specific reasons for rejecting each.
3.3.1 Prohibit Any Pioneer 411 4 Maize from Being Released In response to public comments that might state a preference that no GE organisms enter the marketplace, USDA

- APHIS considered prohibiting the release of Pioneer 4114 Maize , including denying any permits associated with the field testing. USDA

- APHIS determined that this alternative is not appropriate given that Pioneer 4114 Maize is unlikely to pose a plant pest risk ( USDA

- APHIS, 2012e )

. In enacting the Plant Protection Act of 2000 , Congress found that

— [D]ecisions affecting imports, exports, and interstate movement of products regulated under [the Plant Protection Act] shall be based on sound science...§402(4) ( codified at 7 U.S.C. §7701(4))

. On March 11, 2011, in a Memorandum for the Heads of Executive De partments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, consistent with EO 13563, to guide the development and implementation of policies for oversight of emerging technologies (su ch as GE ) at the agency level. In accordance

50DRAFT PIONEER 4114 MAIZE

with this memorandum, agencies should adhere to EO 13563 and, consistent with that EO , the following principle, among others, to the extent permitted by law, when regulating emerging technologies : [D]ecisions sh ould be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency.
Based on its PPRA ( USDA

- APHIS, 2012e ) and the scientific data evaluate d therein, USDA

APHIS concluded that Pioneer 4114 Maize is not likely to present a plant pest risk

. Accordingly, there is no basis in science for prohibiting the release of Pioneer 4114 Maize.
3.3.2 Approve the Petition In Part The regulations at 7 CFR 340.6(d)(3)(i) state that USDA

- APHIS may "approve the petition in whole or in part." For example, a determination of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petitio n. Because USDA

- APHIS has concluded that Pioneer 4114 Maize is unlikely to pose a plant pest risk, there is no regulatory basis under the plant pest provisions of the Plant Protection Act of 2000 for considering approval of the petition only in part.
3.3.3 Isola tion Distance between Pioneer 4114 Maize and Non
- GE Corn and Geographical Restrictions In response to public concerns of gene movement between GE and non

- GE plants, USDA

APHIS considered requiring an isolation distance separating Pioneer 4114 Maize from conventional or specialty corn production. However, because USDA

- APHIS has concluded that Pioneer 4114 Maize is unlikely to pose a plant pest risk ( USDA

- APHIS, 2012e ) , an alternative based on requiring isolation distances would be inconsis tent with the statutory authority under the plant pest provisions of the Plant Protection Act of 2000 and regulations in Part 340.
USDA

- APHIS also considered geographically restricting the production of Pioneer 4114 Maize based on the location of productio n of non

- GE corn in organic production systems in response to public concerns regarding possible gene movement between GE and non

- GE plants. However, as presented in USDA

- APHIS ’ PPRA for Pioneer 4114 Maize , there are no geographic differences associated wi th any identifiable plant pest risks for Pioneer 4114 Maize ( USDA

- APHIS, 2012e )

. Moreover, in 2010, commercial products containing the 1507 x 59122 Maize were grown on approximately 14 million acres, or approximately 16% of the U.S. m ai ze acres ( GfK Kynetec, 2010 ; Pioneer, 2011b )

. Hybrid varieties based on this cross present the same herbicide tolerance and insect resistance traits as Pioneer 4114 Maize. USDA

- APHIS has no regulatory authority over the cultivation of the varieties based on this hybrid. Accordin gly, t his alternative was rejected and not analyzed in detail

. USDA

- APHIS has concluded that Pioneer 4114 Maize does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographically restricted area ( USDA

- APHIS, 2012e ) . Therefore, such an alternative would not be consistent with USDA

- APHIS ’ statutory authority under the plant pest provisions of the Plant Protection Act of 2000 and regulations in Part 340 and the biotechnology regulatory policies embodied in the Coor dinated Framework.

51DRAFT PIONEER 4114 MAIZE

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet USDA

- APHIS ’ purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in Part 340 and the agency‘s authority under the plant pest provisions of the Plant Protection Act of 2000 . Nevertheless, USDA

- APHIS is not expecting substantial effects. However, individuals might choose on their own to geographically isolate their non

- GE corn produc tions systems from corn incorporating the Pioneer 4114 Maize event or to use isolation distances and other management practices to minimize gene movement between cornfields. Information to assist growers in making informed management decisions for hybrid
s tacks based on Pioneer 4114 Maize is available from Association of Official Seed Certifying Agencies ( AOSCA, 2004 )

. 3.3.4 Requirement of Testing for Pioneer 4114 Maize During the comment periods for other petitions for granting nonregulated status, some commenter s requested that USDA require and provide testing for GE products in non

- GE production systems. USDA

- APHIS notes that there are no nationally

- established regulations involving testing, criteria, or limits of GE material in non

- GE systems. Such a requiremen t would be extremely difficult to implement and maintain. Additionally, because Pioneer 4114 Maize does not pose a plant pest risk ( USDA

- APHIS, 2012e ) , the imposition of any type of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act of 2000 , the regulations at Part 340, and the biotechnology regulatory policies embodied in the Coordinated Framework. Therefore , imposing such a requirement for Pioneer 4114 Maize would not meet USDA

- APHIS ’ purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.
3.4 COMPARISON OF ALTERNATIVES
Table 3

- 1 presents a summary of the potentia l impacts associated with selection of either of the alternatives evaluated in this EA. The impact assessment is presented in Section 5 of this EA.
Table 3

- 1 . Summary of potential impacts and consequences of a lternatives.

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status
Meets Purpose and Need and

Objectives No Yes

Unlikely to pose a

plant pest risk Satisfied through use of regulated field trials Satisfied

— risk assessment (USDA

- APHIS, 2012 ( USDA

- APHIS, 2012d ) )
Management

Practices Acreage and Areas of Corn Production 88% of corn grown in U.S. is GE. 49% had stacked herbicide resistance and insect resistance. Corn yields are likely to increase. Uncha nged from No Action Alternative

52DRAFT PIONEER 4114 MAIZE

Agronomic

Practices Cro p rotation can be effective in controlling some insect pests such as rootworm. Reduced or conservation tillage has largely replaced conventional tillage. Unchanged from No Action Alternative

Pesticide Use Insecticide use has declined since the introduction of insect

- resistant corn varieties. Insecticide use will decrease.

Corn Seed Production Unchanged Unchanged

Organic Corn

Production Certified organic corn acreage is a small but increasing percentage of overall corn production. Unchanged from No Action Alternative.

Environment

Land Use Current trends in the acreage and areas of production are likely to continue to be driven by market conditions (i.e., increased demand for US corn and corn products for animal feed, ethanol, etc.) and federal policy Unchanged

Water Resources The primary cause of agricultural NPS pollution is increased sedimentation from soil erosion, which can introduce sediments, fertilizers, and pesticides to nearby lakes and streams. Agronomic practices such as conservation tillage, crop nutrient management, pest
mana gement, and conservation buffers help protect water quality from agricultural runoff Unchanged from No Action Alternative

Soil Agronomic practices such as crop type, tillage, and pest management can affect soil quality. Growers will adopt management practices to address their specific needs in producing corn Unchanged from No Action Alternative

Air Quality Agricultural activities such as burning, tilling, harvesting, spraying pesticides, and fertilizing, including the emissions from farm equipment, can directly affect air quality. Aerial application of insecticides may impact air quality from drift, diffusio n, and volatilization of the Unchanged from No Action Alternative

53DRAFT PIONEER 4114 MAIZE

chemicals, as well as motor vehicle emissions from airplanes or helicopters.

Climate Change Agriculture

- related activities are recognized as both direct sources of greenhouse gases (GHGs) (e.g., exhaust from motorized equipment) and indirect sources (e.g., agriculture

- related soil disturbance, fertilizer production) Unchanged from No Action Alternative

Animals and Plants

Animals Currently available insect

- resistant do not impact popu lations of vertebrate animals or most invertebrate animals. Some varieties target l epidopteran (European
co rn borer and other species) or
c oleopteran (corn rootworm) pests. Non

target invertebrates are generally more abundant in Bt cotton and Bt corn fiel ds than in non

- transgenic fields managed with chemical insecticides . Currently available glufosinate

- resistant varieties do not impact nontarget organisms. 4114 Corn is not expected to have any effect on vertebrate animals or most invertebrate animals. 4 114 Corn is toxic only to certain coleopteran and lepidopteran insects. Effects on these organisms is unchanged from the No Action Alternative

Plants Corn fields can be bordered by other agricultural fields (including other corn varieties), woodlands, o r pasture and grasslands. The most agronomically important members of a surrounding plant community are those that behave as weeds. Corn growers use production practices to manage weeds in and around fields Unchanged from No Action Alternative

Gene Movement Cultivated corn varieties can cross pollinate. Growers use various production practices to limit undesired cross pollination. Unchanged from No Action Alternative

Soil Microorganisms Soil bacterial communities are influenced by plant species and cultivars as well as other environmental factors, such as soil type and agricultural practices. Bt plants may change the soil microbial community when compared to plants that do not express Bt

. No deleterious effects have Unchanged from No Action Alternative

54DRAFT PIONEER 4114 MAIZE

been identified. No effects observed when glufosinate

- resistant plants are cultivated.

Biological Diversity There is no evidence of landscape

- level effects from currently available Bt and/ or glufosinate

- resistant crops. Currently available Bt crops may increase non

target abundance compared to broad

spectrum insecticide use. Unchanged from No Action Alternative.

Human and Animal Health

Risk to Human Health Cry proteins of Bt corn products and the PAT protein are not toxic to humans and do not have any known allergenic properties for humans

. 4114 Corn does not have any adverse human health effects. Limited field releases would not result in adverse health effects. Agricultura l workers and pesticide applicators would be exposed to a variety of US

- EPA

- registered pesticides

. The EPA’s Worker Protection Standard (WPS) (US

- EPA, 1992); 40 CFR Part 170.1, Scope and Purpose ) requires employers to take actions to reduce the risk of pe sticide 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 followi ng pesticide application, decontamination supplies, and emergency medical assistance. Unchanged from No Action Alternative A comprehensive assessment of the safety of 4114 corn demonstrated that the proteins in 4114 are nontoxic to mammals and unlikely t o be a food allergen. US

- EPA

- registered pesticides that are currently used for corn production would continue to be used by growers under the Preferred Alternative. Agricultural production with 4114 corn does not require any change to the agronomic practi ces or chemicals currently used (i.e., pesticides) for conventional corn. Therefore, worker safety issues associated with the agricultural production of 4114 corn would remain the same as those under the No Action Alternative.

Risk to Animal Feed Cry proteins and the PAT protein are not expected to be allergenic, toxic, or pathogenic in mammals or poultry. Cry proteins also have a history of safe consumption in the context of other food and feeds

. A compositional analysis concluded that forage and gr ain from 4114 corn hybrids are considered similar in composition to forage and grain from both the non

transgenic comparator and conventional corn hybrids. Therefore this is unchanged from the No Action Alternative. Socioeconomic

Domestic and Economic Farm income is positively impacted by currently available Bt and herbicide

resistant corn by reducing production Under the preferred alternative, growers would have an additional tool to use against corn insect pests may reduce

55DRAFT PIONEER 4114 MAIZE

Environment costs or increasing revenues. Pest

resistant corn generally has a positive impact on farm income due to cost savings from reduced p esticide use

. economic loss, as well as another tool for herbicide management.

Trade Economic Environment The primary US corn export destinations are also the largest world importers of corn and do not have major barriers for importing food or feed commodities produced from transgenic crops, including those with insect resistance traits. Nevertheless, import of each specific trait requi res separate application and ap proval by the importing country. To avoid adversely affecting international trade in corn commodities exported from the US (and Canada), the developer is taking steps to fulfill regulatory requirements for several countries expected to import the product.

Other Regulatory Approvals FDA completed consultations, EPA tolerance exemptions and conditional pesticide registrations granted FDA completed consultations, EPA tolerance exemptions and conditional pesticide registrations granted Compliance with Other Laws
CWA, CAA, EO s Fully compliant Fully compliant

56DRAFT PIONEER 4114 MAIZE



### 4 ENVIRONMENTAL CONSEQUENCES

4.1 SCOPE OF THE ENVIRONMENTAL ANALYSIS This analysis of potential environmental consequences addresses the potential impact to the human environment from the alternatives analyzed in this EA, namely taking No Action (i.e., leaving current restrictions in place) and the Preferred Alternative (i.e., unconfined cultivation of Pioneer 4114 Maize). Potential environmental impacts from the No Act ion Alternative and the Preferred Alternative for Pioneer 4114 Maize are described in detail throughout this section. A cumulative impacts analysis for each environmental issue is presented in Section 5

– Cumulative Impacts . Certain aspects of this product and its cultivation would be no different between the alternatives; those instances are described below. For the analysis of Environmental Consequences in this draft EA, we note that Pioneer 4114 Maize contains traits from two GE maize varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

. T he Cry1F protein and its associated genetic elements in Pioneer 4114 Maize are identical to those in DAS

‐ 01507

‐ 1 Maize (h ereafter referred to as 1507 Maize), which had a determination of nonregulated status by USDA, was registered by the EPA, and was reviewed by the US

- FDA in 2001 ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- EPA, 2010f ; Pioneer, 2011b ) . The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic el ements are identical to those in DAS

‐ 59122

‐ 7 Maize (hereafter referred to as 59122 Maize), which was reviewed by US

- FDA in 2004, had a determination of nonregulated status by USDA in 2005, and was registered by US

- EPA in 2005 ( US

- FDA, 2004 ; USDA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 201 1b ) . Both 1507 and 59 122 Maize contain the PAT protein, which itself has had nonregulated status since 1995 and has been commercially available in the United States since 1996 ( USDA

APHIS, 1995 )

. The regulatory history of 1507 and 59122 Maize bears repeating here because commercial corn representing hybrids based on these varieties, including a conventional hybrid breeding stack of the two lines, 1507 x 59122, are now licensed broadly across the se ed industry ( Pioneer, 2011b )

. The 1507 x 59122 breeding stack combination was reviewed and registered by US

- EPA in 2005 ( US

- EPA, 2010f )

. Similarly, and as noted in Subsection 2.1, in 2005 , the EFSA approved the marketing of 1507 maize for import, feed and industrial processing and cultivatio n ( EFSA, 2005 ) , in 2007 , approved 59122 for import, feed and industrial processing ( EFSA, 2007 ) , and since 2009, has reviewed and approved at least four commercial hybrids based on the 1507 x 59122 hybrid stacks for food and feed uses, import and processing , in each case concluding and that the hybrid products were unlikely to have any adverse effects on human or animal health or on the environment (see, EFSA, 2009b ; EFSA, 2009a ; EFSA, 2010 ; EFSA, 2011 )

. In 2010, commercial products containing 1507 x 59122 Maize were grown on approximately 14 million acres or approximately 16% of U.S. maize acres ( GfK Kynetec, 2010 ; Pioneer, 2011b )

. Accordingly, as the events contained in Pioneer 4114 Maize are already commercially cultivated, this draft EA presents a summary of the Cry proteins and the PAT proteins and the events in Pioneer 4114 Maize within the Affected Environment section and an analysis with in the Environmental Consequences section

. For the discussion of environm ental consequences, the following principal areas of potential environmental concern are addressed :

57DRAFT PIONEER 4114 MAIZE

• Agricultural Production of Corn (Subsection 4.2);

• Physical Environment (Subsection 4.3);

• Biological Resources (Subsection 4.4);

• Public Health (Subsection 4. 5);

• Animal Feed (Subsection 4.6); and

• Socioeconomic (Subsection 4.7). Although the Preferred Alternative would allow for the cultivation of Pioneer 4114 Maize to occur anywhere in the U nited States for breeding stock, USDA

- APHIS is limiting the environmen tal analysis to those areas that currently support corn production, as identified by the USDA

- NASS 2007 Census of Agriculture ( USDA

- NASS, 2009 )

. The potential environmental consequences of the No Action and Preferred Alternative are analyzed under the assumption that farmers who produce c onventional corn, Pioneer 4114 Maize, or corn using organic methods are using reasonable, commonly accepted best BMP specific to their agricultural corn production.
4.2 AGRICULTURAL PRODUCTION OF CORN

BMP s are commonly accepted, practical ways to grow corn. These management practices consider crop

- specific planting dates, seeding rates, and harvest times, among others. Over the years, corn production has resulted in well

- established management practices that are available through local Cooperative Extension S ervice offices and their respective websites. The National Information System for the Regional Integrated Pest Management (IPM) Centers publishes crop profiles for major crops on a state

- by

- state basis. These crop profiles provide production guidance for l ocal growers, including recommended practices for specific pest control. Crop profiles for many of the corn production states can be reviewed at www.ipmcenters.org/cropprofiles/index.cfm 25

. P ioneer’s studies demonstrate that agronomic characteristics and cultivation practices required for Pioneer 4114 Maize are essentially indistinguishable from practices used to grow other corn varieties, including other GE varieties , such as 1507, 59122, and 1507 x 59122 Maize ( Pionee r, 2011b ; USDA

- APHIS, 2012e )

. None of the BMP s currently employed for corn production is expected to change if Pioneer 4114 Maize is no longer subject to the regulatory requirements of 7 CFR Part 34 0 or the plant pest provisions of the Plant Protection Act of 2000

. Accordingly, the potential impacts on agricultural production of Pioneer 4114 Maize resulting from management practices associated with the No Action and Preferred Alternative are the same , as discussed below in S ubsections 4.2.1

– Areas and Acreage of Corn Production; 4.2. 2

– Agronomic Practices; and 4.2.3

– Organic Corn Farming and Specialty Corn Production

.

25 Last accessed October, 2012.

58DRAFT PIONEER 4114 MAIZE

4.2.1 Areas and Acreage of Corn Production
GE and non

- GE corn varieties are continually under development. In 2012, corn was cultivated on over 96 million acres ( USDA

- NASS, 2012b )

. Approximately 88% of U.S. corn acreage is planted with GE corn ( USDA

- NASS, 2012b )

. 4.2.1.1 No Action: Areas and Acreage of Corn Production Under the No Action Alternative, existing trends related to area and acreage of corn is expected to continue. Corn is expected to continue being commercially cultivated in 48 U.S. S tates, with the majority of production centered in the Midwestern Corn Belt ( USDA

- NASS, 2012b )

. As discussed in Subsection 4.1

– Scope of the Environmental Analysis , Pioneer 4114 Maize contains traits from GE corn varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000

. These corn varieties are 1507, 59122, and 1507 x 59122 Maize ( US

- EPA, 2010f ; Pioneer, 2011b )

. All three
corn products are now licensed broadly across the seed industry ( Pioneer, 2011b ) , covering approximately 16% of U.S. maize acres ( GfK Kynetec, 2010 ; Pioneer, 2011b )

. The current cultivation of these existing corn varieties, especially 1507 x 59122 Maize, strongly suggests that traits contained in Pioneer 4114 Maize (e.g., Cry1F, Cry34Ab1, Cry3 5Ab1, and PAT) will maintain a continued presence in the U.S. corn market under the No Ac tion Alternative

. With regard to acreage, conventional corn production will likely continue to gradually increase , based on current acreage trends ( USDA

- OCE, 2012a )

. Dictating this general increase in U.S. corn acreage are external market forces across many commercial sectors. Increasing demand and favorable net returns for corn products are likely to sustain the market for U.S. corn grain ( USDA

- OCE, 2012a )

. As discussed in Subsection 2.2

– Agricultural Production of Corn , this trend towards increase d corn cultivation is not a result of cultivation of new farm land , but is instead a consequence of the grower’s substitution of corn for other crops to take advantage of current crop pricing ( USDA

- ERS, 2011e )

. For example, t he establishment of a bioethanol industry using corn as a feed stock is one of the key elements in the increase in acreage devoted to corn, with approximately 45 % of the corn harvest dedicated to corn

- based biofuel production (USDA

- ERS, 2012c)

. S i nce 2006, many U.S. cotton farmers have converted to corn and soybean because of favorable prices , and not because of access to a new corn variety ( USDA

- ERS, 2009 ; USDA

- ERS, 2011e )

. Additionally, government policies have and will continue enabling U.S. farmers to meet corn production targets by providing economic incentive to retain arabl e land in agricultural production. For example, two Federal policy tools were enacted to increase the amount of arable land for agricultural production while also encouraging farmer adoption of environmentally

friendly practices to maintain agricultural pr oductivity ( USDA

- ERS, 2011e )

. First, the Food, Conservation, and Energy Act ( 2008 ) required a net reduction in Conservation Reserve Program (CRP) land enrollment from 39.2 to 32 million acres . Second , the Act increased funding for Working Land Cons ervation Programs (e.g., The Environmental Quality Incentives Program [EQIP])

.

59DRAFT PIONEER 4114 MAIZE

4.2.1.2 P referred Alternative: Areas and Acreage of Corn Production
The Preferred Alternative is not expected to extend the area of U.S. corn production or cause an increase in overall corn acreage , relative to the No Action Alternative

. As discussed in Subsection 4.2.1.1

– No Action , Pioneer 4114 Maize already contains traits that are contained in currently

- cultivated corn varieties. This is important to note, as Pioneer 4114 Maize is essentially phenotypically identical to 1507 x 59122 Maize. Accordingly, the p otential impacts of the Preferred Alternative are likely to be similar to the No Action Alternative.
Pioneer’s studies and USDA

- APHIS analyses demonstrate that agronomic characte ristics and cultivation practices required for Pioneer 4114 Maize are essentially indistinguishable from other corn varieties, including 1507, 59122, and 1507 x 59122 Maize ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. Accordingly, P i oneer 4114 Maize might be expected to replace other varieties of corn currently cultivated , such as 1507 x 59122 Maize, that represent approximately 16% of the U.S. corn market ( Pioneer, 2011b )

. Under the Preferred Alternative, t here are no changes in agronomic characteristics in Pioneer 4114 Maize that would result in an a change in the area where corn is cultivated in the United States or an increase in acreage relative to the No Action Alternative ( USDA

- APHIS, 2012e ) . As noted in the No Action Alternative analysis in Subsection 4.2.1.1, the trend in increase in corn acreage is a function of market conditions driving growers to substitute corn for other crops. This trend is not specific to a single GE corn variety and is currently ongoing ( USDA

- ERS, 2011e ) . C onsequently, this trend is not expected to be impacted by a determination of nonregulated status of Pioneer 4114 Maize

. 4.2.2 Agronomic Practices: Tillage, Crop Rotation, and Agronomic I nputs
As discussed in Subsection 2.2.2

– Agronomic Practices , corn cultivation requires substantial management considerations regarding tillage, rotation, and agronomic inputs. Decisions concerning corn agronomic practice s are dependent on grower want and need, and are ultimately reflective of external factors including geography, weed and disease pressure, economics of management of yield, and production system (rotation) flexibility ( Heiniger, 2000 ; Farnham, 2001 ; University of Arkansas, 2008 )

. C hoice of management practice often dictates marketabilit y of a corn product, with certain agricultural consumer sectors stipulating requirements and restrictions regarding corn production methods.
4.2.2.1 No Action: Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs No Action: Tillage and Crop Rotation Under the No Action Alternative, trends related to tillage and crop rotation are likely to continue as currently practiced, as described in Subsection 2.2. 2. 1

– Tillage and Subsection 2.2.2.2

– Crop Rotation

. Prior to planting corn , U.S. growers may use conventional , reduced, or conservation tillage to prepare the soil for planting. Recent data from USDA

- ERS and the USDA Agricultural Resource Ma nagement Survey (ARMS) indicate that conservation tillage has slightly increased in U.S. corn production at the expense of conventional tillage activities between 1998 and 2010 (Figure 4

- 1). During this time period, no

- till activities in U.S. corn production increased by 4% (4.3

60DRAFT PIONEER 4114 MAIZE

million corn acres); however, this adoption of no

- till practices was likely caused by sh ifts from growers already us ing con ser vation tillage and not conventional tillage practices ( NRC, 2010 )

. Figure 4

- 1
. Adoption rates of three major tillage types in U.S. corn production, 1996

– 2010.

Source : USDA

- ERS ( 2012a )

. In contrast to other U.S. commodity crop production systems , trends of conservation tillage adoption in U.S. corn production are not directly attributable to the a doption of GE herbicide

resistant corn varieties ( NRC, 2010 )

. This relatively weak relationship between conservation tillage and herbicide

- resistant corn adoption may be attributed to historical and current corn cu ltivation practices

. Prior to the introduction of herbicide

- resistant corn varieties, some U.S. corn growers were already using conservation tillage practices in their cultivation practices. A large portion of U.S. corn is grown in the Midwestern Corn Belt ( USDA

- NASS, 2012b )

. Due to soil erosion concerns in this region, concerted conservation efforts were encouraged in this area, resulting in s ubstantial increases in reduce d

- till and no

- till corn acreage before herbicide

resistant corn varieties were commercially available ( G ivens et al., 2009 ) . Relative to cotton or soybean, adoption of conservation tillage in corn was higher prior to the development of herbicide

- resistant varieties; consequently, the opportunity for adoption in corn was lower when herbicide

- resistant vari eties were first commercialized ( Givens et al., 2009 )

. As discussed in Subsection 2.2.2.1

– Tillage, plant residues in conservation tillage has been identified as a potential challenge for corn disease and pest management. Recommended disease control measures are currently practiced and include cultivation of resistant hybrids, crop rotation, and more careful balancing of conservation tillage with residue management, with resistant hybrids the most economical method ( Robertson et al., 2009 )

. Under the No Action Alternative, r otation strategies for corn are likely to continue as prac ticed today, with market demand and available technology strongly influencing corn rotation practices. In 2010, 71 % of corn acreage in 19 surveyed states was under some form of rotation ( USDA

0 10 20 30 40 50 60

1996 1997 1998 1999 2000 2001 2005 2010Tillage strategy-% U.S. corn acreage

Year Conservation Tillage Reduced Tillage Intensive (Conventional Tillage)

61DRAFT PIONEER 4114 MAIZE

NASS, 2011d )

. As noted in the No Action analysis in Subsection 4.2.1.1, the trend in increase in corn acreage is a fun ction of market conditions driving growers to substitute corn for other crops , including the decision to adopt corn

- to

- corn production . This trend is not specific to a single GE corn variety ( USDA

- ERS, 2011e ) and is expected to continue as normally practiced under the No Action Alternative. No Action: Agronomic Inpu ts Under the No Action Alternative, current practices related to agronomic inputs in U.S. corn production are likely to continue as currently practiced. Grower application of inputs , as presented in Subsection 2.2.2.3

– Agronomic Inputs, is likely to conti nue as it is at present

. As a consequence of farm

- level decisions discussed in Subsection 2.2.2.3

– Agronomic Inputs , corn g rowers will continue to choose certain pesticides based on weed, insect and disease pressures, cost of seed and other inputs, techn ology fees, human safety, potential for crop injury, and ease and flexibility of the production system ( Heiniger, 2000 ; Farnham, 2001 ; University of Arkansas, 2008 )

. Practices related to fertilizer, insecticide , and herbicide application described in Subsection 2.2.2.3

– Agronomic Inputs is likely to continue as it is practiced tod ay. Corn will continue to receive fertilizer inputs ( Ritchie et al., 2008 )

. The trends noted in Figure 2

- 1 and presented in Subsection 2.2.2.3

– Agronomic Inputs are likely to continue

. H erbicide use as a percent of total corn acres is expected to remain relatively consistent, insecticide use is anticipated to decline as more insect

- resistant varieties are cultivated, and foliar fungicide applications may continue to increase ( Pioneer, 2011b )

. Additionally, also noted in Subsection 2.2.2.3

– Agronomic Inputs , the application of fungicides for seed treatment is expected to continue to increase as more fung icide treatments are brought to the market (see, e.g., Hoeft et al., 2000 ; Ruhl, 2007 )

. I nsecticide use in U.S. corn production has steadily decreased as growers ado pted the use of GE insect

- resistant corn varieties ( Brookes and Barfoot, 2010 ; Benbrook, 2012 ; Brookes et al., 2012 )

. Under the No Action Alternative, Pioneer 4114 Maize will remain a regulated article. However, as noted in Subsection 2.2.2.3

– Agronomic Inputs and Subsection 4.1

– Scope of the Envir onmental Analysis, U.S. corn growers already have access to the insect

- resistant traits in Pioneer 4114 Maize. This includes access to the Cry1F protein in 1507 Maize to manage European corn borer and Cry34Ab1/Cry35Ab1 in 59122 Maize to manage corn root wo rm. This also includes access to a combination of the Cry1F and Cry34Ab1/Cry35Ab1 traits in 1507 x 59122 Maize. Table 4

- 1 provides a complete summary of the US

- EPA registrations for GE insect

- resistant varieties containing Cry proteins found 1507 and 59122 Maize. I n 2010, approximately 16% of the commercial U.S. corn acreage was planted with a 1507 x 59122 hybrid ( Pioneer, 2011b )

. Similar to insecticide use in corn production, herbicide use has been profoundly affected by the adoption of GE herbicide

- resistant corn varieties. As discussed in Subsection 2.2.2 .3

– A gronomic Inputs , the wide adoption of glyphosate

- resistant corn varieties has resulted in glyphosate being applied to approximately 80% of U.S. corn acres ( Pioneer, 2011b )

. In addition to glyphosate resistance , corn varieties have also been genetically engineered to exhibit resistance to glufosinate. Glufosinate use on corn in the United States has been relatively steady and low, accounting for between 2% and 6% of total U.S . corn acreage in the past decade

62DRAFT PIONEER 4114 MAIZE

( Pioneer, 2011b ) . As discussed in Subsection 4.1

– Scope of the Environmental Analysis, GE corn varieties that are resistant to glufosinate include 1507, 59122, and 1507 x 59122 Maize. Other GE glufosinate

- resistant corn varieties are listed in Table 4

- 1. Additionally, other glufosinate

- resistant crops are used in U.S. agriculture ; the use of glufosinate is not a new one

. These var ieties are listed in Table 4

- 2.

63DRAFT PIONEER 4114 MAIZE

Table 4

- 1
. US

- EPA registrations 1 for commercial corn products co ntaining 1507 and/or 59122 Maize
.

Bt Event(s) Product Name Company EPA Reg. Number Initial Date of Registration Expressed Trait Functions

1507 Herculex I Pioneer Hi

- Bred 29964

- 3 May 18,2001 Lepidopteran resistance, resistance to glufosinate ammonium Mycogen Seeds (c/o Dow Agrosciences LLC) 68467

- 2

59122 Herculex Rootworm Pioneer Hi

- Bred 29964

- 4 Aug. 31,2005 Coleopteran resistance, resistance to glufosinate ammonium Mycogen Seeds (c/o Dow Agrosciences LLC) 68467

- 5

1507 x 59122 Herculex XTRA Mycogen Seeds (c/o Dow Agrosciences LLC) 68467

- 6 Oct. 27,2005 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium Pioneer Hi

- Bred 29964

- 5

MON89034 2 x 1507 x MON88017 3 x 59 122 Genuity ® SmartStax ® Monsanto Company 524

- 581 July 20, 2009 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium; added lepidopteran resistance from Cry1A.105 and Cry2Ab2 and coleopteran resistance from Cry3Bb1 Mycogen Seeds (c/o Dow Agrosciences LLC) 68467

- 7

1507 x MON810 4 Optimum Intrasect Pioneer Hi

- Bred 29964

- 7 Feb. 24,2010 Lepidopteran resistance, resistance to glufosinate ammonium; added l epidopteran resistance from Cry1Ab 1507 xMON810 x 59122 Optimum lntrasect Extreme Pioneer Hi

- Bred 29964

- 8 Feb. 24,2010 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium; added l epidopteran resistance from Cry1Ab 90% 1507 x 59122 + 10% 1507 Optimum AcreMax 1 Pioneer Hi

- Bred 29964

- 6 April 30, 2010 Lepidopteran and c oleopteran resistance, resistance to glufosinat e ammonium 90% 59122 + 10%
non
- Bt Optimum AcreMaxRW Pioneer Hi

- Bred 29964

- 10 April 30, 2010 Coleopteran resistance, resistance to glufosinate ammonium and refuge
Bt 11 x MIR162 5 x 1507 Agrisure Viptera 3220 Syngenta Seed Inc. 67979

- 15 March 29, 2011 Lepidopteran resistance, resistance to glufosinate ammonium; added lepidopteran resistance from Vip3Aa20

95% MON89034 x 1507 x MON88017 x 59122 + 5% non

- Bt Genuity ® SmartStax ® RIB Complete Monsanto Company 524

- 595
April 8, 2011 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium and glyphosate ; added lepidopteran resistance from Cry1A.105 and Cry2Ab2 and coleopteran resistance from Cry3Bb1 and a refuge. Mycogen Seeds (c/o Dow Agrosciences LLC) 68467

- 16

64DRAFT PIONEER 4114 MAIZE

Table 4

- 1
. US

- EPA Registrations 1 for Commercial Corn Products Containing 1507 and/or 59122 Maize. Continued.

Bt Event(s) Product Name Company EPA Reg. Number Initial Date of Registration Expressed Trait Functions

Bt 11 6 x 1507 x MIR604 7 x 59122 Agrisure 3 122 Syngenta Seed Inc. 67979

- 17 June 10,2011 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium; added lepidopteran resistance from Cry1Ab and coleopteran resistance from Cry3A. 90% 1507 x MON810 x 59122 + 10% non

Bt Optimum AcreMax Xtra Pioneer Hi

- Bred 29964

- 11 Aug. 26, 2011 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium; added lepidopteran resistance from Cry1Ab and a 10%refuge.

95% 1507 x MON810 + 5% non

- Bt Optimum AcreMax Pioneer Hi

- Bred 29964

- 12 Aug. 26, 2011 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium; added lepidopteran resistance from Cry1Ab and a 5% refuge

1507 x MIR604 Optimum Trisect Pioneer Hi

- Bred 29964

- 13 Sept. 30, 2011 Lepid opteran resistance, resistance to glufosinate ammonium; added coleopteran resistance from Cry3A.

1507 x 59122 x MON810 x MIR604 + 5% non

- Bt Optimum AcreMax Xtreme Pioneer Hi

- Bred 29964

- 16 March 7, 2012 Lepidopteran and c oleopteran resistance, resistance to glufosinate ammonium; added lepidopteran resistance from Cry1Ab and coleopteran resistance from Cry3A and a 5% refuge. Notes:

1. EPA registrations are focused on the Bt

- based PIPs (the Cry proteins) presented in 1507 and 59122 Maize. US

- EPA has no regul atory authority over the herbicide resistance expressed by the various maize varieties. To the extent that information was available, the herbicide resistance expressed by the respective maize products is provided. 2. MON89034 expresses the Cry1A.105 and Cry2 Ab2 proteins, conferring resistance to certain lepidopterans. 3. MON88017 expresses the Cry3Bb1 protein, conferring resistance to certain coleopterans. 4. MON810 expresses the Cry1Ab protein, conferring resistance to certain lepidopterans. 5. MIR162 expresses the V ip3Aa20 protein, extracted from Bt , conferring resistance to certain lepidopterans. 6. Bt 11 expresses the Cry1Ab protein, conferring resistance to certain lepidopterans. 7. MIR604 expresses the Cry3A protein, conferring resistance to certain coleopterans.

65DRAFT PIONEER 4114 MAIZE

Table 4

- 2 . USDA

- APHIS nonregulated products expressing the PAT protein conferring resistance to DL

- Phosphinothricin, the ammonium salt of glufosinate, also known as glufosinate ammonium.

Year of Nonregulation APHIS Product Identification Number Petitioner Crop Traits 1995 94

- 357

- 01p Agrevo Corn Phosphinothricin

- resistant 1996 95

- 145

- 01p DeKalb Corn Phosphinothricin

- resistant 1996 96

- 068

- 01p Agrevo Soybean Phosphinothricin

- resistant 1998 97

- 205

- 01p Agrevo Rapeseed Phosphinothricin

- resistant 1998 97

- 265

- 01p Agrevo Corn Phosphinothricin

- resistant , Lepidopteran

- resistant 1998 97

- 336

- 01p Agrevo Sugar beet Phosphinothricin

- resistant 1998 97

- 342

- 01p Pioneer Corn Male sterile and Phosphinothricin

resistant 1998 98

- 014

- 01p Agrevo Soybean Phosphinothricin

- resistant (note relation to 96

- 068

- 01p petition) 1998 98

- 238

- 01p Agrevo Soybean Phosphinothricin

- resistant 1999 98

- 278

- 01p Agrevo Rapeseed Phosphinothricin

- resistant and pollination control 1999 98

- 329

- 01p Agrevo Rice Phosphinothricin

- resistant 1999 98

- 349

- 01p Agrevo Corn Male sterile and Phosphinothricin

resistant 2001 00

- 136

- 01p Mycogen c/o Dow and Pioneer Corn Lepidopteran

- resistant and Phosphinothricin

- resistant ( 1507 Maize ) 2002 01

- 206

- 02p Aventis Rapeseed Phosphinothricin

- resistant 2002 01

- 206

- 01p Aventis Rapeseed Phosphinothricin

- resistant and pollination control 2003 02

- 042

- 01p Aventis Cotton Phosphinothricin

- resistant 2004 03

- 181

- 01p Dow Corn Lepidopteran

- resistant and Phosphinothricin

- resistant 2005 03

- 353

- 01p Dow Corn Coleopteran

- resistant and Phosphinothricin

- resistant ( 59122 Maize ) 2006 06

- 234

- 01p Bayer Rice Phosphinothricin

- resistant 2011 08

- 340

- 01p Bayer Cotton Phosphinothricin (glufosinate)

- resistant and Lepidopteran

- resistant Note: The information presented in this table was extracted from the USDA

- APHIS BRS Table of Petitions for Nonregulated Status Granted or Pending as of November 12 , 2012 , found at http://www.aphis.usda.gov/biotechnology/not_reg.html

Under the No Action Alternative, g rowers will likely continue to experi ence the continued emergence of Bt

- resistant insect pests and gl yphosate

- resistant weeds. These trends require modifications of crop management practices to address these challenges, including the use of alternative herbicides for weed control ( Norsworthy et al., 2012 ) , alternative insect control strategies (including alternative PIP s), mechanical cultivation practices, and strict adherence to crop refug ia requirements ( Benbrook, 2009 ; Gassmann et al., 2011 )

.

66DRAFT PIONEER 4114 MAIZE

4.2.2.2 Preferred Alternative: Agronomic Practices: Tillage, Crop Rotation, and Agronomic Inputs Preferred Alternative: Tillage and Crop Rotation Under the Preferred Alternative, current trends and practices related to tillage and crop rotation in U.S. corn production are unlikely to be substantially different than that which is occurring under the No Action Alternative in Subsection 4.2.2.1

– Agronomic Practices

. As discussed in Subsectio n 4.2.2.1

– No Action : Agronomic Practices , the adoption of GE herbicide

- resistant corn varieties did not strongly affect trends related to the adoption of conservation tillage practice s in U.S. corn production. As a n herbicide

- resistant (i.e., glufosinate

resistant ) corn variety that is intended to replace cultivation on some acres of a very similar herbicide

- resistant corn variety (e.g., 1507 x 59122 Maize) , Pioneer 4114 Maize is unlikely to substantially affect tillage practices in corn

. Consequ ently , p atterns of tillage are unlikely to be substantially different under the Preferred Alternative compared to the No Action Alternative

. Pioneer 4114 Maize is essentially indistinguishable from other currently cultivated corn varieties in terms of agronomic ch aracteristics and cultivation practices ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. This includes 1507 x 59122 Maize, a currently

- available corn variety that is phenotypically identical to Pioneer 4114 Maize. This strongly suggests that Pioneer 4114 Maize would likely benefit from the crop rotation strategies discussed in Subsection 2.2.2.2

– Crop Rotation. However, as discussed in Subsection 4.2.2.1

– No Action: Agronomic Practices , growers may currently adopt crop rotation strategi es based upon market and field conditions

. A determination of nonregulated status of Pioneer 4114 Maize is unlikely to change these market conditions, as market demand for corn is dependent on product end use and not any one GE corn variety. Accordingly, c rop rotation in corn is unlikely to be substantially different under the Preferred Alternative compared to the No Action Alterative

. Preferred Alternative: Agronomic Inputs Under the Preferred Alternative, agronomic inputs associated with U.S. corn produc tion is likely to continue as described in the analysis of the No Action Alternative in Subsection 4.2.2.1

– Agronomic Practices

. Pioneer 4114 Maize is essentially indistinguishable from other currently cultivated corn varieties in terms o f agronomic characteristics, c ultivation practices , and disease susceptibility ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. This suggests that Pioneer 4114 Maize would require similar levels of fertilization as conventional corn varieties and be nefit from the use of fungicides . Under the Preferred Alternative, Pioneer 4114 Maize is unlikely to substantially affect trends related to fertilization and fungicide use compared to the No Action Alternative. Under the Preferred Alternative, Pioneer 411 4 Maize will provide growers access to insect

resistant and herbicide

- resistant traits that are already available to U.S. corn growers . As noted in Subsection 2.2.2.3

– Agronomic Inputs and Subsection 4.1

– Scope of the Environmental Analysis, this include s the Cry1F protein in 1507 Maize to manage European corn borer and
67DRAFT PIONEER 4114 MAIZE

Cry34Ab1/Cry35Ab1 in 59122 Maize to manage corn root worm. This also includes access to a combination of the Cry1F and Cry34Ab1/Cry35A b1 traits in 1507 x 59122 Maize. Additionally, U.S. co rn growers will continue having access to glufosinate

- resistant corn varieties. Glufosinate

- resistant corn varieties also include 1507, 59122, and 1507 x 59122 Maize. A determination of nonregulated status of Pioneer 4114 Maize would provide growers with
c ontinued access to corn breeding stock product expressing multiple Cry proteins offering resistance to lepidopteran and coleopteran pests. In 2010, commercial corn products containing 1507 x 59122 Maize were grown on approximately 14 million acres, or appr oximately 16% of the U.S. corn acres ( GfK Kynetec, 2010 ; Pioneer, 2011b )

. As Pioneer 4114 contains the same insect

- resistant traits as 1507 x 59122 Maize, is virtually indistinguishable from 1507 x 59122 Maize, and is intended to replace 1507 x 59122 Maize on some U.S. corn acres, trends related to insecticide use would likely continue as currently practiced under No Action Alternative

. This includes , as described in Subsection 2.2 .2.3

– Agronomic Inputs and Subsection 4.2.2.1

– No Action , a decrease in the volume of insecticides ( Brookes and Barfoot, 2012 ; Brookes et al., 2012 )

. A determination of non regulated status is unlikely to substantially affect glufosinate use in U.S. corn production. As described in Subsection 2.2.2.3

– Agronomic Inputs and Subsection 4.2.2.1

– No Action , glufosinate is already used on corn. There are no proposed label changes for glufosinate use associated with the cultivation of Pioneer 4114 Maize ( Pioneer, 2011b ) , meaning that glufosin ate use patterns will remain the same as currently

- available glufosinate

- resistant corn varieties

. Additionally, because Pioneer 4114 Maize is phenotypically identical to 1507 x 59122 Maize, it can be reasonable expected that Pioneer 4114 Maize will replace some 1507 x 59122 Maize acreage. USDA

- APHIS assumes that all glufosinate use would be in accordance with the label application requirements established by the US

- EPA

. For these reasons, glufosinate use trends under the Preferred Alternative are not expected to be substantially different than glufosinate use trends under the No Action Alternative.
Trends related to the development of and the management of Bt

- resistant insect pests and glyphosate

- resistant weed populations are not anticipated to be substantially different for the Preferred and No Action Alternatives. Pioneer 4114 Maize is phenotypically identical to 1507 x 59122 Maize, a GE corn variety already cultivate d in the United States , and is thus intended to replace some 1507 x 59122 Maize acreage . Pioneer 4114 Maize will likely require similar refuge requirements and cultivation practices as 1507 x 59122 Maize. Accordingly, Bt

- resistant insect pests and glyphosa te

- resistant weed populations may continue to develop , as described in 4.2.2.1

– No Action. However, strategies to manage resistant insect and weed pests are likely to be as applicable to Pioneer 4114 Maize as the currently

- cultivated 1507 x 59122 Maize. T hus, the trends related to the evolution of and the management of Bt

- resistant insect pests and glyphosate

resistant weed populations are not anticipated to be substantially different between the Preferred and No Action Alternatives

. A determination of non regulated status of Pioneer 4114 Maize would continue providing growers with another corn hybrid exhibiting resistance to glufosinate ammonium, offering another option for managing glyphosate

- resistant weeds

— a potentially valuable trait in those corn cultivation areas where herbicide

- resistant weeds have emerged. This could allow for 68DRAFT PIONEER 4114 MAIZE

improved corn grain yields when grown in the vicinity of glyphosate

- resistant weeds. This practice of using herbicides with alternative modes of action is expected to potentially diminish the populations of glyphosate

- resistant weeds ( Dill et al., 2008 ; Duke and Powles, 2008 ; Owen, 2008 ; Duke and Powles, 2009b )

. Applications of herbicides with mixed modes of action also are expected to prolong the development of new herbicide

- resistant weed populations ( Owen, 2008 ; Duke and Powles, 2009b )

. 4.2.3 Organic Corn Farming and Spec ialty Corn Production
4.2.3.1 Organic Corn Farming Organic production plans prepared pursuant to the NOP include practical methods to prevent co

mingling of organic and GE corn. The adventitious presence of GE corn with organic corn is a
concern for some, knowing that corn naturally cross

- pollinates ( Coulter et al., 2010 ) , though common agricultural practices are already used by corn growers to limit cross pollina tion

. Typically, organic growers use more than one method to prevent unwanted material from entering their fields including: isolation of the farm; physical barriers or buffer zones between organic production and non

- organic production; planting border or barrier rows to intercept pollen; changing planting schedules to ensure flowering at different times; and maintaining formal communications between neighboring farms ( NCAT, 2003 ; Baier, 2008 ; Roth, 2011 )

. These practices follow the same system u s ed for the cultivation of c ertified seed under the AOSCA procedures. During the growing season , gene flow is managed by understanding corn pollen dispersal and maintaining adequate distances between fields ( Thomison, 2009 ; Mallory

Smith and Sanchez

- Olguin, 2011 )

. A minimum isolation distance of 250 feet between varieties is recommended; whereas, 700 feet is preferred for complete isolation ( Diver et al. , 2008 )

. USDA

- APHIS recognizes that producers of non

- GE corn, particularly producers who sell their products to markets sensitive to GE traits (e.g., organic or some export markets), reasonably can be assumed to be using practices on their farm to prot ect their crop from unwanted substances and thus maintain their price premium. USDA

- APHIS will assume that growers of organic corn are already using, or have the ability to use, these common practices as USDA

- APHIS ’s baseline for the analysis of the altern atives.
No Action: Organic Farming In 2011, certified organic corn production was approximately 169,000 acres, representing a decrease from approximately 194,000 acres in 2008 ( USDA

- NASS, 2012a )

. This decrease occurred in the presence of GE and non

- GE corn varieties. Organic corn production is occurring in the presence of convention al corn production using GE and non

- GE corn varieties. As d iscussed in Subsection 4.1

– Scope of the Environmental Analysis, some of these currently

- cultivated corn varieties include 1507, 59122, and 1507 x 59122 Maize

. Under the No Action Alternative, it is likely that organic corn farming will continue in the presence of these GE corn varieties.

69DRAFT PIONEER 4114 MAIZE

Organic producers employ a variety of measures to manage identity and preserve the integrity of organic production systems ( NCAT, 2003 ) . Historically, or ganic corn production represented a smal l percentage (approximately, 0.2%) of total U.S. corn acreage ( USDA

- ERS, 2011g )

. The percentage of corn acreage dedicated to organic c orn is not anticipated to change under the No Action Alternative. Current availability of seed for conventional (both GE and non

- GE) corn varieties, and those corn varieties that are developed for organic production, is expected to remain the same under th e No Action Alternative. Organic growers are already using accepted agricultural practices to reduce or limit cross pollination between corn varieties . The grower strategies employed to support this are not expected to change and likely will remain the sam e under the No Action Alternative. Planting and production of GE, non

- GE, and organic corn will continue to fluctuate with market demands, as it has over the last 10 years, and these markets are likely to continue to fluctuate under the No Action Alternati ve ( USDA

- ERS, 2011f ; USDA

- ERS, 2011h ; USDA

- ERS, 2012c )

. Preferred Alternative: Organic Farming Organic corn production is unlikely to be affected by a determination of nonregulated status for Pio neer 4114 Maize. As discussed in Subsection 4.1

– Scope of the Environmental Analysis , c orn varieties containing the Cry and PAT proteins in Pioneer 4114 Maize are already cultivated in the United States (e.g., 1507, 59122, and 1507 x 59122 Maize). I n 2010, commercial corn products containing 1507 x 59122 Maize were grown on approximately 16% of U.S. maize acres ( GfK Kynetec, 2010 ; Pioneer, 2011b )

. Pioneer 4114 Maize may be expected to replace some 1507 x 59122 Maize acreage, as the corn varieties are phenotypically identic al

. Additionally , agronomic trials conducted in a variety of locations in the United States demonstrated that Pioneer 4114 Maize is not substantially different in plant growth, yield, and reproductive capacity from conventional corn, including 1507 x 59122 Maize ( USDA

- APHIS, 2012e )

. No differences were observed in pollen diameter, weight, and viability. Therefore, Pioneer 4114 Maize is expected to present a no greater risk of cross

- pollination than that of existing corn cultivars , including 1507 x 59122 Maize

. The practices currently employed to preserve and maintain purity of organic production systems would not be required to change to accommodate the production of Pioneer 4114 Maize. Accordingly, the determination of nonregulated status of Pio neer 4114 Maize is not expected to have a substantial impact on organic corn production , as it likely that Pioneer 4114 Maize will simply replace some of 1507 x 59122 Maize that is already cultivated

. 4.2.3.2 Specialty Corn Production
No Action: Specialty Systems Specialty corn production is occurring in the presence of convention corn production using GE and non

- GE corn varieties. As discussed in Subsection 4.1

– Scope of the Environmental Analysis , some of these currently

- cultivated corn varieties include 1507, 5 9122, and 1507 x 59122 Maize

. Under the No Action Alternative, it is likely that specialty corn production will continue in the presence of these GE corn varieties.

70DRAFT PIONEER 4114 MAIZE

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 na tural barriers to pollen ( Wozniak, 2002 ; NCAT, 2003 ; Bradford, 2006 ; Thomis on, 2009 ; Roth, 2011 )

. These management practices allow the grower to meet standards for the production of specialty crop seed, maintain genetic purity, and protect the genetic diversity of corn ( Bradford, 2006 )

. Current availability of seed for specialty corn varieties is expected to remain the same under the No Action Alternative. The supply chain practices described in Subsection 2.2.3.2

– Specialty Corn which growers employ to preserve and maintain identity (e.g. , isolation distances, planting of border and barrier rows, field monitoring, and seed handling standards and practices from planting, harvesting transportin g, storage and cleaning are not expected to change (see, e.g., Wozniak, 2002 ; AOSCA, 2004 ; Bradford, 2006 )

. Preferred Alternative: Specialty Systems As noted in the discussion of Seed Production and Organic Corn Production, no changes in the production or cultivation of specialty corn are required to accommodate Pioneer 4114 Maize , as Pioneer 4114 Maize is simil ar to conventional corn, including the already

- cultivated 1507 x 59122 Maize variety

. According to the petition, agronomic trials conducted in a variety of locations in the United States demonstrated that Pioneer 4114 Maize is not subst antially different in plant growth, yield, and reproductive capacity from its conventional corn ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. No differences were observed in pollen diameter, weight, and viability. Therefore, Pioneer 4114 Maize is expected to present a similar risk of cross

- pollination as existing corn cultivars including other GE corn varieties. The practices currently employed to preserve and maintain purity of specialty corn production systems would not be required to change to accommodate the production of Pioneer 4114 Maize. A determination of nonregulated status of Pioneer 4114 Maize under the Preferred Alternative would not change the availability and genetic purity of seed for specialty corn varieties. Conventio nal management practices and procedures, as described previously for corn seed production, proper seed handling, protection of wild relatives of corn, and organic corn farming, are in place to protect and maintain the genetic diversity of corn. Corn grower s have u s ed these methods effectively to meet the standards for the production of specialty crop seed. Impacts would be similar to the No Action Alternative. Specialty system farmers, or other farmers who choose to plant non

- GE corn varieties or sell
non
- G E corn seed, are unlikely to be impacted by the expected cultivation of Pioneer 4114 Maize. Transgenic corn lines including those that contain herbicide

- resistant and insect

- resistant traits are already in use by farmers. Pioneer 4114 Maize should not pres ent any new and different issues and impacts for specialty corn producers and consumers.

71DRAFT PIONEER 4114 MAIZE

4.3 PHYSICAL ENVIRONMENT
4.3.1 Soil Quality This subsection discusses the potential consequences of the No Action and the Preferred Alternative on soil quality

. Conservation tillage historically has not been the major tillage system in corn production. In 1996, over 60% of the corn acreage was either conventional (30%) or reduced tillage (32%), with the balance split between mulch and no

- till systems ( Christensen, 2002 )

. As noted in Subsection 2. 2

. 2 .1

– Tillage , minimal tillage in corn was being adopted prior to the introduction of GE herbicide

- resistant varieties ( Givens et al., 2009 )

. The soil environment in and around crop fields is complex and rich in microorganisms, including bacteria and fu ngi. Potential impacts on microorganisms are discussed in Subsection 4.4. 3

– Soil Microorganisms.
4.3.1.1 No Action: Soil Quality Under the No Action Alternative, soil quality will remain the same as the present. Current agronomic practices associated with corn production including tillage, cultivation, applications of pesticides and fertilizer, and the use of agricultural equipment are not expected to change under the No Action Alternative. As discussed in Subsection s 2.2

- Agronomic Practices and 2.3. 1

– Soil Q uality , current cultivation practices reduce insecticide use, and substitute glufosinate for more toxic herbicides, providing potential indirect soil quality benefits ( Towery and Werblow, 2010 ; Brookes et al., 2012 ) . Risks are reduc ed associated with environmental spills or misapplications of chemical herbicides and insecticides to the soil, as well as reductions in the frequency with which these products may be applied. As corn resistant to glufosinate and containing the Cry proteins within Pioneer 4114 Maize are already on the market (e.g., 1507, 59122, and 1507 x 59122 Maize) , these indirect benefi ts to soil quality do not change under the No Action Alternative

. T he development of glyphosate

- resistant weeds or weed management tillage practices potentially impact soil quality. A variety of strategies should be utilized in addressing glyphosate

- resistant weeds, including applying the right strength of herbicide, rotating herbicide modes of action, crop rotation, spot treatments, vigilant scouting, and hand weeding ( Gunsolus, 2002 ; Sellers et
a l., 2011 )

. In the long term, more diverse weed management tactics , potentially including more aggressive tillage practices that can affect soil quality , may be needed to address the increasing emergence of glyphosate

- resistant weeds ( Be ckie, 2006 ; Owen, 2011 ; Owen et al., 2011b ) . The particular mix of weed management tactics selected by an individual producer is dependent upon many factors, including the agroecological setting, the problem weed type, and a gronomic and socioeconomic factors important to farmers ( Beckie, 2006 )

. As noted above in Section 4.2.2

– Agronomic Practices, glufosinate is already used on the LibertyLink ® corn varieties, such as 1507 x 59122 Maize

. I n 2010, glufosinate was applied on approximately 2% of U.S. corn acreage. Glufosinate ammonium is weakly a d sorbed to and is highly mobile in soil, undergoes rapid microbial degradation in soil, and has a short soil residual half

- life of between 12 and 70 days ( CERA, 2002 ; Senseman, 2007 ; US

- EPA, 2008b )

. Glufosinate has high leaching potential in soil; however, it degrades rapidly and, therefore, is 72DRAFT PIONEER 4114 MAIZE

typically found no deeper than 15 centimeters (approximately 6 inches) in soil ( Senseman, 2007 ) . Implementation of BMP to slow soil erosion and filter pollutants from surface runoff, such as vegetated strips, control of spray drift, and adherence to label restrictions governing safe application and equipment cleanup, minimize the potential for pesticide impacts to soil ( US

EPA, 2008b ) . Information on the direct impacts of glufosinate to soil microorganisms is presented in Subsection 4.4. 3

– Soil Microorganisms

. As noted in Subsection 4.1

– Scope of the Environmental Analysis , the PAT and Cry p roteins are currently cultivated, resulting in widespread dispersal of these protein s in U.S. cornfields

. The pat gene was originally isolated from S

. viridochromogenes; t he Bt genes encoding for t he Cry proteins were originally isolated from Bt ( Pioneer, 2011b )

. Both S

. viridochromogenes and B

. thuringiensis are naturally occurring soil bacteria and are not pathogenic ( US

- EPA, 1998 ; Hérouet et al., 2005 )

. GE corn varieties containing Cry proteins, including 1507 x 59122 Maize, are already cultivated in the United States. The Bt source for the Cry proteins is ubiquitous in soils ( US

- EPA, 1998 )

. Bt toxins (e.g., Cry1F, Cry34Ab1, and Cry35Ab1) may persist in soils for several months ( US

- EPA, 1998 ) . Howev er, proteins do not bio

- accumulate; the biological nature of these Cry proteins makes them readily susceptible to metabolic, microbial, and abiotic degradation ( US

- EPA, 2010b ; US

- EPA, 2010a ) . Field deposition of Cry protein s is associated with plant material (i.e., p ollen, crop residue) or plant root exudates (e.g., carbohydrates and amino acids) ( US

- EPA, 2010b ; US

- EPA, 2010a ) . This plant material typically stimulates microbial activity and reproduction. The US

- EPA has determined that the Cry proteins are degraded rapidly by soi l microflora upon elution from the soil ( US

- EPA, 2010b ; US

- EPA, 2010a )

. The US

- EPA notes that many of the early experiments establishing Cry protein persistence in soil were based on bulk soil, rather than soils representing field conditions ( US

- EPA, 2010b ; US

EPA, 2010a ) . These bulk soil experiments did not represent the realistic field conditions, including degradation pathways in soil ( US

- EPA, 2010b ; US

- EPA, 2010a ) . The US

- EPA expects that degradation rates under field conditions may be higher than bulk soil experiments would sugg est ( US

- EPA, 2010b ; US

- EPA, 2010a ) . Additionally, although the US

- EPA found that the Cry proteins showed little degradation in soils with low pH (pH 5), the US

- EPA also noted that corn does not grow well below pH 5.6; therefore, under most production conditions, corn would not be grown on soils that would inhibit the rate of degradation ( US

- EPA, 2010b ; US

- EPA, 2010a ) . The potential impacts of inadvertent exposure of non

- target organisms to the residual Cry proteins in soil are discusse d in Subsection 4.4. 3

– Soil Microorganisms.
4.3.1.2 Preferred Alternative: Soil Quality
Under the Preferred Alternative , soil quality is not anticipated to be substantially different. As noted in Subsection 4.1

– Scope of the Environmental Analysis , Pioneer 4114 M aize contains identical genetic elements as 1507 and 59122 Maize varieties and represents a co rn variety that is functionally equivalent to 1507 x 59122 Maize ( Pioneer, 2011b )

. The crop management practices for Pioneer 4114 Maize will be the same as those employed for 1507, 59122, and 1507 x 59122 Maize

. No changes to agronomic practices typically applied in the cultivation of corn, including both commercially available GE corn as well as conventional varieties, are required for Pioneer 73DRAFT PIONEER 4114 MAIZE

4114 Maize ( Pioneer, 2011b )

. Pioneer’s field trial and laboratory analyses demonstrated that the agronomic performance of Pioneer 4114 Maize was phenotypically identical to its non

transgenic hybrids used as controls in the tests ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. Cultivation of Pioneer 4114 Maize did not require increases in ap plications of agronomic inputs or changes in cultivation, planting, harvesting, and volunteer control ( Pioneer, 2011b )

. The same practices employed for corn varieties under the No Action Alternative would be employed to cultivate Pioneer 4114 Maize varieties. Pioneer 4114 Maize offers growers another varietal option to apply glufosinate ammonium to control weeds in corn , though it is worth noting that Pioneer 4114 Maize may replace cultivation of the existing 1507 x 59122 Maize variety . As noted above in the No Action discussion, as well as S ubs ection 4.2.2

– Agronomic Practices, glufosinate is already used on corn varieties grown in the United States , and was applied on app roximately 2% of the U.S. corn acreage in 2010

. Because glufosinate use is not expected to change in U.S. corn production, it is unlikely that soil quality will be substantially

- affected by glufosinate use in Pioneer 4114 Maize. Most corn acreage is curren tly planted to either glyphosate

- resistant

- only corn or herbicide

resistant corn varieties stacked with other GE traits ( Duke and Powles, 2009a ; USDA

- ERS, 2011b )

. M ore diverse weed management tactics potentially including more aggressive tillage practices that can affect soil quality may be needed to address the increasing emergence of glyphosate

- resistant weeds ( Beckie, 2006 ; Owen, 2011 ; Owen et al., 2011b )

. Weed management practices needed for the production of 4114 corn would be no different than those used in other commercially available gl ufosinate

- resistant corn cultivars.
Pioneer 4114 Maize is com positionally equivalent to conventional corn, including 1507, 59122, and 1507 x 59122 Maize ( USDA

- APHIS, 2012e )

. Consequently, any crop residue remaining in the field to decompose is not anticipated to present any substantial indirect effects to soil quality compared to the No Action Alternative

. The corn varieties on which Pioneer 4114 Maize is based, 1507, 59122, and 1507 x 59122 Maize , have been commercially available for many years ( Pioneer, 2011b ) . There are no reports of impacts to soil resources associated with the commercial cultivation of these varieties. Consequently, cultivation of Pionee r 4114 Maize is not anticipated to negatively affect soil quality relative to the No Action Alternative following a determination of nonregulated status.
4.3.2 Water Resources
Corn is a water

- sensitive crop with a low tolerance for drought, although the stress response and yield loss depends on the stage of the corn growth ( Farahani and Smith, 2011 )

. Corn requires approximately 4,000 gallons through the growing season to produce one bushel of grain ( NCGA, 2007a )

. The water demand is variable over the growing season. The greatest water demand occurs during the silk production stage in mid

- season and is estimated at approximately two inches of water per week (or 0.3 inches per day) ( Heiniger, 2000 ; Farahani and Smith, 2011 )

. As discussed in Subsections 2.3.1 and 4.3.1, conser vation tillage practices, particularly no

- till practices, are currently practiced on U.S. corn acres ( Horowitz et al., 2010 )

. Intensive monitoring
74DRAFT PIONEER 4114 MAIZE

of surface water and groundwater proximate to agricultural fields has demonst rated that conservation tillage practices can reduce runoff from agricultural lands, decreasing NPS pollution of suspended sediment, nutrients from fertilizer s , and pesticides ( University of Tennessee Agricultural Extension Service, 2010 )

. Better nutrient management, including precision farming and variable rate applications, are ensuring inputs are used by the crop and are not entering ground or surface waters ( US

- EPA, 2005 ; USDA

- NRCS, 2006b )

. The US

- EPA considers water resources, and potential contamination of water resources, when registering a pesticide under FIFRA. Precautions to protect water resources, including aquatic animals and plants, if required, are provided on the pesticide label

. 4.3.2.1 No Action : Water Resources Under the No Action Alternative, current land acreage and agronomic practices, including irrigation, tillage, and nutrient management associated with U.S. corn production would not be expected to change. Among the many GE corn varieties a vailable, U.S. g rowers would continue to cultivate 1507, 59122 and 1507 x 59122 hybrid varieties and continue the agronomic practices and inputs associated with those varieties. These practices and inputs would include the use of glufosinate as an herbicid e , as well as inclusion of the introduced Cry proteins as part of an insect pest management strategy. No expected changes to water use beyond current trends associated with corn production are expected for this alternative.
As discussed in Subsection 4.2. 2

– Agronomic Practices , the herbicide glufosinate ammonium is already approved for use on corn ( USDA

- NASS, 2011a )

. As noted in Subsection 2.2

– Agricultural Production of Corn , w ith the commercial introduction of GE herbicide

- resistant crops, persistent residual herbicides were replaced with shorter half

- life herbicides that were more environmentally benign ( Fernande z
- Cornejo and Caswell, 2006 ; Shipitalo et al., 2008 ; Vencill et al., 2012 )

. C urrently capturing only approximately 2% of the corn market, glufosinate is considered one of these more benign products; b ecause of glufosinate’s shorter half

- life and lower sorption potential , glufosinate losses to surface water are lower than that reported for other herbicides ( Battaglin et al., 2005 ; Shipitalo et al., 2008 )

. Glufosinate has not been found to be a source of impairment for any water body designated as impaired under § 303(d) of the Clean Water Act ( US

- EPA, 2008b ) . Surface water may be impacted by glufosinate residues transported by runoff, but US

- EPA label restrictions minimize potential impacts to water ( US

- EPA, 2008b ) . Glufosinate may leach to groundwater under certain conditions (such as soils with high permeability and shallow groundwater), but glufosinate degrades rapidly in soil from microbial activity and is rarely found deeper than 15 centimeters (approximately 6 inches) from the soil surface ( Senseman, 2007 )

. Glufosinate is highly water soluble and stable in water; is considered to be essentially nonvolatile from soil an d surface water, and adsorption to suspended solids and sediment has been observed to be low to high ( US

- EPA, 2000 ; HSDB, 2010 ) . Biodegradation occurs in water bodies with a half

- life greater than 64 days ( US

- EPA, 2000 )

. The US

- EPA has considered the potential impacts to water resources from the agricultural application of glufosinate ammonium, and has included label use restrictions and guidance for product handling intended to prevent impacts to water ( see, e.g., Bayer, 2012 )

. Label restrictions specific to water resource s include, for example, 75DRAFT PIONEER 4114 MAIZE

prohibiting applications directly to water (except as allowed for rice), managing proper disposal of equipment wash water, and adopting cultivation methods (e.g. , no till) to limit runoff to surface water, and not applying the herbicide when rainfall is forecasted to occur within 48 hours ( Bayer, 2012 ) . The implications of exposure to glufosinate are discussed in Subsection 4.4.1

– Animal Comm unities.
As discussed in Subsection 4.1

– Scope of the Environmental Analysis, the Cry proteins in Pioneer 4114 Maize are already used in U.S. corn production, appearing for example, in 1507, 59122, and 1507 x 59122 Maize. This means that the US

- EPA has already considered potential impacts to surface water in its evaluation of Cry proteins as PIPs (see, e.g., US

- EPA, 1998 ; US

EPA, 2010b ; US

- EPA, 2010a ) . The major source of Cry proteins in freshwater is corn pollen ( US

- EPA, 2010b ; US

- EPA, 2010a )

. The EPA has determined that there are no risks to aquatic
o rganisms from exposure to Cry proteins in corn pollen and other plant tissues in aquatic environments ( US

- EPA, 2010b ; US

- EPA, 2010a )

. Cry proteins are not considered a risk to drinking water or groundwater ( US

- EPA, 1998 ) . The implications of inadvertent exposure to
non
- target freshwater organisms are discussed in Subsection 4.4.1

– Animal Communities.
4.3.2.2 Preferred Alternative: Water Resources Under the Preferred Alternative, no substantial impact to water resources is anticipated from a determination of nonregulated status of Pioneer 4114 Maize, as it is functionally equivalent to currently

- cultivated corn varietie s (e.g., 1507 x 59122 Maize). With regard to irrigation, n o differences in morphological characteristics and agronomic requirements were found between Pioneer 4114 Maize and conventional corn, including 1507, 59122, and 1507 x 59122 Maize ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. This strongly suggests that Pioneer 4114 Maize does not require more moisture than conventional corn. Also, as previously discussed in Subsection 4.2.1

– Areas and Acreage of Corn Production , the use of P ioneer 4114 Maize would not increase the total acres and range of U.S. corn production areas. Because Pioneer 4114 Maize is expected to be cultivated in lieu of some corn varieties already in wide

- commercial use (e.g. , 1507 x 59122), the consequences of the Preferred Action Alternative on water use in corn production are the same as the No Action Alternative. Therefore, a determination of nonregulated status of Pioneer 4114 Maize is unlikely to change the current use of irrigation practices in commercial corn production compared to the No Action Alternative.
As discussed in Subsection 4.2.2

– Agronomic Practices , the herbicide glufosinate ammonium is already approved for use on corn, and the proposed application rates an d total maximum annual application for use on Pioneer 4114 Maize are consistent with the current rates ( Pioneer, 2011b ; Pioneer, 2012 )

. Because Pioneer 4114 Maize is expected to be cultivated in lieu of some corn varieties already in wide

- commercial use (e.g. , 1507 x 59122) , and use of glufosinate on Pioneer 4114 Maize is the same as these potentially replaced corn varieties, no substantial impacts to
wa ter resources from glufosinate use are anticipated under the Preferred Alternative compared to the No Action Alternative. The corn varieties on which Pioneer 4114 Maize is based, 1507, 59122, 1507 x 59122 Maize , have been commercially available for many ye ars. The genetic elements in Pioneer 4114 are
76DRAFT PIONEER 4114 MAIZE

identical to the 1507 and 59122 Maize varieties. Consequently, it is unlikely that substantial impacts to water resources will occur as a result of Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins, as there are no r eports of impacts to water resources associated with the commercial cultivation of these varieties. Additionally, US

- EPA has already considered potential impacts to surface water in its evaluation of Cry proteins as PIPs, as described in the No Action Alte rn ative (see, e.g., US

- EPA, 1998 ; US

- EPA, 2010b ; US

- EPA, 2010a ) . Cry proteins are not considered a risk to drinking water or groundwater ( US

- E PA, 1998 )

. Based on these findings, t he potential impacts to water resources are expected to be the same under the Preferred Alternative as under the No Action Alternative

. 4.3.3 Air Quality
As discussed in Subsection 2.3.3

– Air Quality , t raditional agricul tural practices have the potential to cause negative impacts to air quality. Agricultural emission sources include smoke from agricultural burning, tillage, heavy equipment emissions, pesticide drift from spraying, and indirect emissions of carbon dioxide and nitrous oxide the degradation of organic materials in the soil and from the use of nitrogen fertilizer ( USDA

- NR CS, 2006a ; Aneja et al., 2009 )

. Current corn agronomic practices have the potential to reduce air emissions from several of these
sources. Conservation practices, including conservation tillage practice s , require fewer tractor passes across a field, thereby decreasing dust generation and tractor emissions. Surface residues and untilled organic matter physically serve to hold the soil in place, thereby decreasing airborne soils and pesticide drift in wind

- eroded soils.
4.3.3.1 No Action: Air Quality Under the No Action Alternative, current impacts to air quality associated with land acreage and cultivation practices associated with corn production , including cultivation practices related to GE corn varieties suc h as 1507, 59122 , and 1507 x 59122 Maize , are not likely to be affected.
A doption of GE corn varieties is expected to continue. To the extent that the adoption and cultiva tion of GE corn varieties allow the grower to implement soil conservation practices presented in Subsection 4.3.1

– Soil Quality , air quality improvement associated with these practices would be expected to follow. This would include both direct air quality effects, e.g. , emissions from farm equipment, airborne soil erosion and pesticide drift, as well as indirect air quality effects, e.g. , decreased carbon dioxide emissions associated with the use of conservation tillage ( Hoeft et al., 2000 ; USDA

- NRCS, 2006a ; Aneja et al., 2009 ; US

- EPA, 2012b )

. Air quality will continue to be affected by current agronomic practices associated with conventional methods of corn production such as tillage, cultivation, pesticide and fertilizer applications, and the use of agricultural equipment.
4.3.3.2 Preferred Alternative: Air Quality Under the Preferred Alternative, a determination of nonregulated status of Pioneer 4114 Maize is unlikely to substantially impact air quality compared to the No Action Alternative.

77DRAFT PIONEER 4114 MAIZE

Pioneer 4114 Maize is similar in agronomic performance and likely requires similar cultivation practices as currently

- cultivated conventional corn varieties, including 1507, 59122, and 1507 x 59122 Maize ( USDA

- APHIS, 2012e )

. As discussed in S ubsection 2.2

– Agricultural Production of Corn, Pioneer 4114 Maize production is unlikely to change land acreage or any cultivation practices for conventional, transgenic, or non

- transgenic corn production. It is ex pected that similar agronomic practices that are currently used for commercially available corn varieties, such as 1507, 59122, and 1507 x 59122 Maize, would also be used by growers of Pioneer 4114 Maize. Agronomic practices that have the potential to impa ct air quality will be the same for Pioneer 4114 Maize as they are for corn products like 1507, 59122, and 1507 x 59122 Maize that
are currently cultivated on U.S. cornfields

. Based on this information, USDA

- APHIS concludes that the cultivation of Pioneer 4114 Maize is not expected to adversely affect air quality

. 4.3.4 Climate Change Agriculture, including land

- use changes associated with farming, is responsible for an estimated 6% of all human

- induced GHG emissions in the U nited States ( US

- EPA, 2012b )

. Agriculture

related GHG emissions include CO 2 , N 2 O, and CH 4 , produced through the combustion of fossil fuels to run farm equipment; the use of fertilizers; or the decomposition of agricultural waste products , including crop residues, animal wastes, and enteric emissions from livestock. N 2 O emissions from agricultural soil ma nagement (primarily nitrogen

- based fertilizer use) represent 69% of all U.S. N 2 O emissions ( US

- EPA, 2012b )

. A comprehensive discussion of the contribution of agricultural practices to GHGs is provided in Subsection 2.3.4

– Climate Change.
Conservation tillage practices used in U.S. corn production ha ve been identified as pr oviding climate change benefits ( see, e.g., Brenner et al., 2001 )

. Conservation t illage, discussed above in Agronomic P ractices (Subsections 2.2.2 and 4.2.2) and S oil Quality (Subsections 2.3.1 and 4.3.1) , in addition to providing benefits to soil quality , also has the benefit of increasing carbon sequestration in soils. Switching from conventional tillage to a no

- till corn

- soybean rotation in Iowa, for example, has been estimated to increase carbon sequestration by 550 kg/hectare (485 lb/acre) per year ( Paustian et al., 2000 ; Brenner et al., 2001 ; Towery and Werblow, 2010 )

. 4.3.4.1 No Action: Climate Change Under the No Action Alternative, Pioneer 4114 Maize would remain a regulated article. Accordingly, environmental releases of Pioneer 4114 Maize would continue under the USDA

APHIS notification and permitting process

. As discussed in Subsection 4.1

– Scope of the Environmental Analysis Current , corn varieties similar to Pioneer 4114 Maize would continue to be cultivated in the United States under the No Action Alternativ e. These currently

- available corn varieties include 1507, 59122, and in particular, 1507 x 59122 Maize. Consequently, agronomic practices associated with production of 1507, 59122, 1507 x 59122 Maize , and conventional corn varieties would continue. As disc ussed in Subsection 2.3.4

– Climate Change, these common agronomic practices contribute to GHG emissions, including tillage, cultivation, irrigation, pesticide application, fertilizer
78DRAFT PIONEER 4114 MAIZE

applications, and use of agriculture equipment

. Because these common agr icultural practices are not expected to change under the No Action Alternative, these common agricultural practices are also not expected to change if Pioneer 4114 Maize remains a regulated article.
To the extent that U.S. corn growers are able to implement conservation practices, GHG emissions are expected to continue to be reduced commensurate with the air quality improvements anticipated from adoption of conservation tillage practices. For example, the US

EPA has identified a net reduction in the sequestration of carbon in soil over a 20

- year time scale, which it attributes to the declining influence of the Conservation Reserve Program which had encouraged growers to take marginal lands out of production ( US

- EPA, 2012c ) . To a certain extent, the US

- EPA also noted that adoption of cons ervation tillage resulted in increases in carbon sequestration in soils on those croplands ( US

- EPA, 2012c ) . The highest rates of carbon sequestration in mineral soils occurred in the Midwest, which is the region with the largest area of cropland managed with conservation tillage ( US

- EPA, 2012c ) . This is in contrast to the highest emissi on rates from organic soils noted in the southeastern coastal region, the areas around the Great Lakes, and the central and northern agricultural areas along the West Coast ( US

- EPA, 2012c )

. 4.3.4.2 Preferred Alternative: Climate Change Under the Preferred Alternative, a determination of nonregulated stat us of Pioneer 4114 Maize would not change the cultivation or agronomic practices, or agricultural land acreage associated with growing corn, and thus is expected to have the same effect on climate change as the No Action Alternative. To the extent that the cultivation of a corn variety exhibiting resistance to glufosinate ammonium allows a grower to minimize conventional tillage and adopt conservation tillage practices, the potential impacts associated with the Preferred Alternative would be the same as tho se under the No Action Alternative.
As discussed in Subsection 4.2.1

– Areas and Acreage of Corn Production , the culti vation of Pioneer 4114 Maize is not expected to convert new land to corn cultivation. As discussed in Subsection 4.2.2

– Agronomic Practic es , the management practices associated with the cultivation of Pioneer 4114 Maize and hybrids based on that variety are anticipated to be the same as those for current cultivation of 1507, 59122 and the 1507 x 59122 Maize

. Based on these findings, there a re no substantial differences between the No Action Alternative and the Preferred Alternative on climate change

. 4.4 BIOLOGICAL RESOURCES

4.4.1 Animal Communities Corn production systems in agriculture are host to a variety of animal species. A number of insect pests as well as beneficial insects feed on corn plants or prey upon other insects inhabiting cornfields. Although cornfields generally are considered poor h abitat for birds and mammals in comparison with uncultivated lands, the use of cornfields by birds and mammals is not

79DRAFT PIONEER 4114 MAIZE

uncommon. This subsection discusses the potential consequences of the No Action and the Preferred Alternatives on animal communities assoc iated with corn fields

. 4.4.1.1 No Action: Animal Communities
Mammal s and Birds Under the No Action Alternative, Pioneer 4114 Ma ize remains a regulated article

. However , the proteins contained within Pioneer 4114 Maize (i.e., Cry1F, Cry34Ab1, Cry35ab1, and PAT) wi ll remain in the U.S. corn market, as these proteins are already contained in other cultivated GE corn varieties. This includes the cultivation of 1507 (Cry1F and PAT proteins) , 59122 (Cry34Ab1, Cry35Ab1, and PAT proteins) , and 1507 x 59122 ( Cry1F, Cry34Ab 1, Cry35Ab1, and PAT ) Maize

. Potential impacts of GE and non

- GE corn production practices on non

- target terrestrial (insect, bird, and mammal) and aquatic (fish, benthic invertebrate, and reptile ) species would be unchanged.
As discussed in S ubsection 2.4 .1

– Animal Communities, the majority of birds and mammals use corn as food and not for shelter, due to regular agricultural disturbances (e.g., use of agricultural machinery, application of pesticides, etc.)

. T he exposure pathway for the majority of bird and mammal species to GE corn varie ties is through consumption of corn grain. Existing GE corn varieties containing the same Cry and PAT proteins at Pioneer 4114 Maize , including 1507, 59122, and 1507 x 59122 Maize , will continue to be commercial ly cultiva t ed un der the No Action Alternative. Consequently , b irds and mammals will continue to be primarily exposed to these GE corn varieties and their respective introduced proteins through the consumption of corn grain

. The Cry proteins in 1507 and 59122 Maize are derived from Bt subsp. a izawai (Cry1F) and Bt strain PS149B1 (Cry 34Ab1 and Cry35Ab1) , respectively ( USDA

- APHIS, 2012e ) . The modifying PAT enzyme, encoded by the pat gene, is derived from S. viridochromogenes ( Pioneer, 2011b ) . Both B. thuringiensis and S. viridochromogenes are naturally occurring soil bacteria and are not pathogenic. Animals are regularly exposed to these organisms and their components withou t adverse consequences ( Hérouet et al., 2005 ; US

- EPA, 2007a ; US

- EPA, 2010b ; US

- EPA, 2010a ; Pioneer, 2011b ; U S

- EPA, 2012f )

. US

- EPA considers animal exposure in the registration of pesticides under FIFRA, including the review of Cry proteins as PIPs. When reviewing the toxicity of these Cry proteins as PIPs, the EPA considers acute oral exposure involvi ng a pure preparation of the PIP at d oses over 5,000 mg/kg bodyweight as well as chronic exposure tests using a diet where the PIP comprised 10% of the diet ( US

- EPA, 2010a ; US

- EPA, 2010b )

. The EPA has also evaluated environmental exposures based on laboratory studies to predict lowest observed effects concentrations (LOEC) and no observed effects concentrations (NOEC) ( US

- EPA, 2010a )

. In these studies, the EPA has found no overt signs of toxicity associated with anticipated exposures in field conditions ( US

- EPA, 2010a ; US

- EPA, 2010b )

. USDA

- APHIS has found no evidence that the presence of the Bt and pat genes or the accumulation of the Cry and PAT proteins would have any impact on animals, including animals beneficial to agriculture ( USDA

- APHIS, 2012e )

. Glufosinate is already being applied to corn. As discussed in Subsection 2.2

– Agricultural Production of Corn , the use of glufosinate on corn has been steady, ranging from 2% to 6% of U.S. corn acreage ( Pioneer, 2011b )

. The 80DRAFT PIONEER 4114 MAIZE

US

- EPA first registered glufosinate ammonium in 2000 as a non

- selective foliar herbicide for use on a wide range of crops ( US

- EPA, 2008b ; US

- EPA, 2008a ) . In 2008, the US

- EPA
announc ed that it was undertaking a registration review of this product, and has published a final work plan for this process ( US

- EPA, 2008a )

. US

- EPA ’s a ssessments of the toxicity of glufosinate i ndicated a relatively low risk to animals ( US

- EPA, 2008b ) . On an acute exposure basis, glufosinate is considered practically nontoxic to birds, mammals, and insects; slightly toxic to freshwater fish, slightly toxic to estuarine/marine fish; moderately toxic to freshwater and estuarine/marine invertebrates; and toxic to terrestrial and aquatic plants ( US

- EPA, 2008b )

. As of the March 2008 Glufosinate Summary Document Registration Review , there were insufficient data available on terrestrial plant toxicity for an ecological assessment t o be completed ( US

- EPA, 2008b ) . Based on the data collected as of the 2008 review summary, however, the areas of concern are impacts to non

- target plants, chronic toxicity to mammals, and the indirect impacts to terrestrial ani mals from potential alterations in aquatic plant communities ( US

- EPA, 2008b ) . The EPA requires additional plant toxicity and field dissipation studies to determine potential impacts of typical end

- use products. Existing environ mental assessments of the toxicity of glufosi nate to animal species indicate a relatively low direct risk, but high risk to plants composing the animals’ habitat ( US

- EPA, 2008b ) . On an acute exposure basis, glufosinate is consi dered practically nontoxic to birds, mammals, and insects; slightly non

- toxic to freshwater fish; slightly toxic to estuarine/marine fish; moderately toxic to freshwater and estuarine/marine invertebrates; and toxic to terrestrial and aquatic plants ( US

- EPA, 2008b ) . For birds, glufosinate is practically non

- toxic on an acute and sub

- acute dietary basis; therefore, the risk potential is presumed to be low ( US

- EPA, 2008b )

. Non

- target exposure for plants typically results from runoff or drift. Although animals also can be affected from runoff and drift, ingestion is often the most important exposure pathway. As discussed above in Subsection 4.3.3

– Air Quality, the US

- EPA la bel provides measures to control drift. Adherence to label use restrictions will ensure that the use of the herbicide will not adversely affect animals or critical habitat ; l abeled uses of glufosinate are approved pending the outcome of the US

- EPA ’s ecolog ical risk analysis ( US

- EPA, 2008a )

. Invertebrates Under the No Action Alternative, non

- target invertebrates will continue to be exposed to GE corn varieties and their respective introduced proteins. As discussed in Subsection 4.1

– Scope of the Environmental Analysis, GE corn varieties that contain the same introduced proteins as 4114 Maize will continue to be cultivated. Additionally, glufosinate will also continue to be applied to U.S. corn acreage. Potential impacts related to non

- target inver tebrates will continue as it currently exists in U.S . corn production under the No Action Alternative.
The most relevant invertebrates in a corn field ar e those that are pests of corn. Under the No Action Alternative, GE insect

- resistant corn varieties, suc h as 1507, 59122, and 1507 x 59122 Maize will continue to be available to U.S. corn growers for control of major insect pests, such as European corn borer or western corn rootworm

. However, t he efficacy of GE insect

- resistant hybrids may decrease if resist ance develops in the target insect population. Y ield losses and corn l odging caused by rootworm pressure have been observed in limited areas of planted Bt

expressing hybrids and have been attributed to resistance ( Hodgson and Gassman, 2011 )

.
81DRAFT PIONEER 4114 MAIZE

Under the No Action Alternative and discussed in Subsection 2.4.1.2

– Invertebrates , U.S. growers cultivating Bt corn varieties are required to adopt IRM strategies to delay the development of insect resistance as a result of continued exposure to Cry proteins. One of the key strategies required by the US

- EPA involves the incorporation of refuges into their IRM practices ( see, e.g., US

- EPA, 2010f ) . The US

- EPA has approved refuge strategies for 1507, 59122 , a nd 1507 x 59122 Maize ( US

- EPA, 2010f ) . The refuge strategy is based on the concept that resistant insect pests will mate with susceptible pests from nearby refuges of host plants without Bt toxin , thus producing offspring that are susceptible to the Bt corn crop 26 ( Tabashnik, 2008 ; Tabashnik et al., 2008 ) . Refuge strategies can include a field or a block or strip of non

- Bt corn that does not contain a Bt trait ( US

- EPA, 2010f ) . Recently, the US

- EPA also has approved an integrated refuge s trategy, named “refuge in a bag , ” where non

- Bt seeds are blended with the Bt corn products and planted randomly within the field to ensure that refuge requirements are followed ( Pioneer, 2012 )

. Insect resistance to plant

- incorporated Bt proteins has been reported (see, e.g., Blanco et al., 2010 ; Storer et al., 2010 ; Gassmann et al., 2011 ; Kilman, 2011 ; Blake, 2012 )

. Inherent resistance to certain Bt toxins has been identified in wild target insect populations in several fields in Iowa, Puerto Rico and Australia ( Blanco et al., 2010 ; Storer et al., 2010 ; Gassmann et al., 2011 ; Kilman, 2011 ; Blake, 2012 )

. The areas where insect resistance have been reported reflect a very small proportion of the total acreage cultivat ed in Bt corn (several fields in Iowa as compared with 67% of the 96 million acres planted in Bt corn in 2012 as noted in Table 2

- 1.). It is important to note that w here insect resistance has been identified in Bt cornfields , the development of insect resi stance appears to be the result of growers’ failure to exercise appropriate management strategies to preserve and protect against insect resistance. In Puerto Rico, for exampl e, fall a rmyworm was identified as resistant to the Cry1F protein ( Blanco et al., 2010 ; Storer et al., 2010 ) . The corn va rieties in which resistance was identified in Puerto Rico had been cultivated in the same fields for 12 consecutive production cycles , and typical IPM measures, including varietal rotation and refuge strategies were not well implemented ( Storer et al., 2010 )

. In Puerto Rico, this continuous, overlapping production exer ts substantial selection pressure towards Bt

- resistant insect pests. Similarly, in the Iowa reports, insufficient planting of refuge is believed to have contributed to the development of resistance ( Gassmann et al., 2011 )

. In the absence of refuge plantings, non

- resistant insects are less available to b reed, increasing the likelihood of the development of resistance ( Tabashnik, 2008 ; Tabashnik et al., 2008 ) . In response to the emergence of insect pest resistance noted in Puerto Rico , Pioneer and Dow AgroSciences stopped selling 1507 Maize in Puerto Rico and have worked with growers to imple ment a more robust integrated pest management program, including chemical insecticides ( US

- EPA, 2010b )

. Additionally, Gassmann et al. ( 2011 ) noted that the emergence of resistant corn rootworm was likely the result of the growers’ failure to adhere to the US

- EPA ’s refuge strategies to preserve Bt effectiveness; in each of the cases of resistance, the same corn varieties had been cultivated for several consecutive years within the same fields ( Gassmann et al., 2011 ) . Gassmann found that

26 Assuming that resistance is a recessive genetic trait.
82DRAFT PIONEER 4114 MAIZE

although corn rootworm had developed resistance to the Cry3Bb1 protein, no cross resistance was demonstrated to other Cry proteins, including Cry34Ab1/Cry35Ab1 ( Gass mann et al., 2011 ) . The lack of cross resistance suggests that creating hybrid corn varieties accumulating multiple Cry proteins is likely to preserve beneficial insect

- resistant traits in corn

. Additionally, other common corn production practices may h elp in preserving the integrity of beneficial insect

resistant traits. For example, c rop rotation in corn conducted to optimize soil nutrition and fertility, may also reduce pathogen loads and control corn pests ( IPM, 2004 ; IPM, 2007 )

. Crop rotation practices have been described previously in Section 2 .2.2.2

– Crop Rotation

. W idespread failure of control measures using Bt crops has not been observed, despite some evidence of Bt resistance, in part due to IRM strategies, including supplemental pesticide use and refuges ( Tabashnik et al., 2008 ) . In the case of Bt corn grown in the Corn Belt, refuge acres are typically 5 % to 20 % of the cornfield area, depending on the product’s requirements ( US

- EPA, 2010f ) . Greenhouse and laboratory tests suggest that insects under intense selection pressure by Cry proteins over multiple generations may develop resistance rapidly in the absence of a refuge to sustain susceptible populations. These data in combination with the report of field resistance to a Bt pro duct further emphasize the importance of effective refuges for resistance management ( Meihls et al., 2008 ) . Resistance management strategies, which ar e mandated by US

- EPA’s terms of Bt corn product registrations ( US

- EPA, 2010f ) have been developed for all Bt corn produc ts to mitigate the risk of pest resistance and to implement additional measures if resistance
occurs. Despite the need for additional attentiveness to p otential impacts of Bt

- resistance in insect pests , professional advice given to growers is that multiple tactics do not necessarily need to be employed simultaneously. Thus, University of Illinois Extension staff ( Gray, 2011a ) suggest that neither 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 non

- rootworm

- resistant crops, or using pyramided hybrids, and adult rootworm suppress ion should all be considered ( Gray, 2011a )

. Grower decisions should be based on corn price, identification of fields with high CRW populations, trait performance at the location, and whether other soil pests are present. Long term pe rspectives for managing rootworm populations and other pests need to be taken, along with a fully integrated approach ( Gray, 2011b )

. 4.4.1.2 Preferred Alternative: Animal Communities
Mammals and Birds Under the Preferred Alternative, potential impacts to mammals and birds are not anticipated to be substantially different compared to the No Action Alternative. As discussed in Subsection 4.1

– Scope of the Environmental Analysis , Pioneer 4114 Maize is phenotypically identical to currently

- cultivated corn varieties, such as 1507 x 59122 Maize.
As discussed in Subsection 4.2

– Agricultural Production of Corn , a determination of nonregulated status of Pioneer 4114 Maize is not expected to impact agronomic practices for the cultivation of corn. Pioneer anticip ates Pioneer 4114 Maize might replace some of the acres 83DRAFT PIONEER 4114 MAIZE

currently planted with products containing 1507 x 59122 Maize, but is not expected to cause new corn acres to be planted in areas that are not already in agricultural production ( Pioneer, 2012 )

. Accordingly, mammal and bird communities not already impacted by corn cultivation are not expected to be substantially impacted by a determination of nonregulated status of Pio neer 4114 Maize compared to the No Action Alternative

. In that regard, the potential exposure of animals to typical corn cultivation practices and the introduced proteins in Pioneer 4114 Maize under the Preferred Alternative is anticipated to be the same a s under the No Action Alternative.
As noted in Subsection 4.1

– Scope of the Environmental Analysis , the Cry1F, Cry34Ab1/Cry35Ab1 and PAT proteins contained in Pioneer 4114 Maize have been commercially available for a number of years . As seen in Table 4

- 1 , many different GE corn varieties containing these proteins, including the 1507 x 59122 Maize , have been registered by the US

- EPA . No impacts to animal communities associated with exposure to these proteins in
corn have been reported ( US

- EPA, 2010b ; US

- EPA, 2010a )

. Consequently, because Pioneer 4114 Maize contains identical genetic elements as 1507, 59122, and 1507 x 59122 Maize, it is unlikely that a substantial impact would occur on the bird and mammal community following consumption of Pioneer 4114 Maize grai n under the Preferred Alternative compared to the No Action Alternative. A recent laboratory study in which mice were fed either a diet of 4114 maize or a diet of non

- GE maize showed no significant differences in performances between the two groups ( Delaney et al., 2013 )

. Pioneer has evaluated the potential allergenicity and toxicity of the proteins introduced in Pioneer 4114 Maize and found no meaningful amino acid similarities with known allergens or toxins ( Pioneer, 2011b ) . This finding was to be expected, as these proteins have been cultivated for many years, including 1507 x 59122 Maize

. These exposures are no different than those under the No Action Alternative

. Further discussion on the potential impacts from the consumption of Pioneer 4114 Maize is presented in Subsection 4.6

– Animal Feed. A determination of nonregulated status of Pio neer 4114 Maize also is not expected to result in a change in the use of glufosinate on corn. GE corn varieties containing resistance to glufosinate has been available and cultivated commercially for many years under the Liberty ® trade name ( see http://www.aphis.usda.gov/biotechnology/not_reg.html USDA

- APHIS, 2012b ) . The proposed application rates for glufosinate application on Pioneer 4114 Maiz e are identical to those currently approved for use on corn ( Pioneer, 2012 )

. A determination of nonregulated status for Pioneer 4114 Maize is not expected to require a cha nge in the US

- EPA registration or label for this herbicide ( Pioneer, 2011b ) . Current label application rates and associated use restrictions for herbicides are designed by the US

- EPA to minimize the potential impacts of the use of glufosinate to non

- target organisms. USDA

- APHIS assumes that the herbicide will be used in accordance with these label restrictions. Under the Preferred Alternative, t here are no differences from t he No Action Alternative in the use of glufosinate associated with cultivation of Pioneer 4114 Maize.
Invertebrates Under the Preferred Alternative, non

- target invertebrates will continue to be exposed to the agronomic practices that are common in U.S. cor n cultivation. In particular, non

- target 84DRAFT PIONEER 4114 MAIZE

invertebrates will continue to be exposed to the agronomic practices that are used to produce currently

- available GE corn varieties because Pioneer 4114 Maize is functionally equivalent to currently available varieties, such as 1507 x 59122 Maize, and thus, requires similar growing practices.
Pioneer assessed the non

- target impact of Pioneer 4114 Maize on beneficial organisms in the corn agroecosystem, including the l adybird beetle s ( Hippodamia convergens and C oleomegilla maculata ), the Monarch butterfly ( Danaus plexippus ), parasitic wasps ( N asonia vitripennis ), the green lacewing ( Chrysoperla carnea ), and the honeybee ( Apis mellifera ) ( Pioneer, 2012 ) ( USDA

- APHIS, 2012e ) . Pioneer did not report any impacts on the abundance or diversity of
non
- target beneficial organisms in the field ( Pioneer, 2011b ; USDA

- APHIS, 2012e ) . Based on a review o f this information, USDA

- APHIS has found no evidence that the presence of the Bt and pat genes or the presence of the Cry and PAT proteins would have any impact on non
- target invertebrates , including non
- target invertebrates beneficial to agriculture under the Preferred Alternative compared to the No Action Alternative ( USDA

- APHIS, 2012e )

. As discussed in Subsection 2. 4.1

. 2

– Invertebrates and the N o A ction analysis in Subsection 4.4.1.1 , growers are required by the US

- EPA to incorporate re fuge strategies to delay the development of insect resistance from exposure to the Cry proteins ( see, e.g., US

- EPA, 2010f )

. As noted in the No Action discussion in Subsection 4.4.1.1 , the US

- EPA has published such strategies for cultivating the 1507, 59122, and 1507 x 59122 hybrids. Because Pioneer 4114 contains identical Cry protein s as these currently

- available insect

- resistant corn varieties and is phenotypically identical to 1507 x 59122 Maize ( Pioneer, 2012 ) , t hese refuge strategies would not change under the Preferred Alternative

. Implementation of refuge strategies would be the same as the No Action Alternative as would currently

- available and practices corn cultivation strategies to reduce selection pressure for Bt

- resistance in insect pests

. Based on these findings, USDA

- APHIS has determined that the impacts to the invertebrate community under the Preferred Alternative are the same as those under the No Action Alternative.
4.4.2 Plant Communities The landscape surrounding a cornfield may be bo rdered by a number of vegetative communities, including other crop fields, woodland, fencerows, rangelands, and/or pasture/grassland areas. These plant communities may represent natural or managed plant buffers for the control of soil and wind erosion and also may serve as habitats for a variety of transient and non

- transient wildlife species. Additionally, the surrounding plant landscape may also influence non

- crop plants (i.e., weed species) that grow within a corn production field. In this context, weed s are those plants which, when growing in the field, compete with the crop for space, water, nutrients, and sunlight ( IPM, 2004 ; IPM, 2007 ; University of California, 2009 )

. Weed control progr ams are important aspects of corn cultivation. The types of weeds in and around a cornfield will vary depending on the geographic region where the corn is grown. Additionally, corn grain may remain in a field and germinate the following season among co rn o r other crops. These corn plants are known as
85DRAFT PIONEER 4114 MAIZE

volunteer corn plants. This subsection discusses the potential consequences of the No Action and the Preferred Alternatives on plant communities.
4.4.2.1 No Action: Plant Communities Under the No Action Alternative, Pioneer 4114 Maize will remain a regulated article. Plant species (i.e., weeds) that typically inhabit GE and non

- GE corn production systems will continue to be managed through the use of mechanical and chemical control met hods, as currently practiced. Multiple herbicides, including the herbicide glufosinate, will continue to be used on corn. Volunteer corn will continue to be controlled by the recommended ACCase inhibitors and ALS inhibitors ( Hager, 2009 )

. Surrounding Landscapes and Other Vegetation in Cornfields Under the No Action Alternative, plant communities surround ing a cornfield may be subject to off

- site movement of pesticides as described in S ubs ection s 2.3.2

– Water Resources, 2.3.3

– Air Quality, and 2.4.2

– Plant Communities. In particular, herbicides such as glufosinate may affect
non
- target plants through run off/leaching and spray drift.
As noted in Subsection 4.1

– Scope of the Environmenta l Analysis , c orn varieties exhibiting resistance to glufosinate have been available commercially since 1996 . Despite its availability, application volumes of glufosinate have remained low in comparison to glyphosate ( Pioneer, 2012 )

. Glufosinate label rates for application to resistant corn varieties are from 28 to 34 fluid oz. per acre, not more than twice per season with a maximum annual application of 62 fluid ounces per acre, applied post

- emergent, using
over
- the

- top broadcast or drop nozzles from emergence until the corn is 24” tal l or in theV

- 7 growth stage ( Bayer, 2012 )

. The current label fo r glufosinate can be found at http://fs1.agrian.com/pdfs/Ignite_280_SL_Herbicide_Label5a.pdf Surface water may be impacted by glufosinate residues transported by runoff under th e No Action Alternative

. Glufosinate may leach to groundwater under certain conditions (such as soils with high permeability and shallow groundwater), but glufosinate degrades rapidly in soil from microbial activity and is rarely found deeper than 15 centi meters from the soil surface ( Senseman, 2007 )

. Glufosinate is highly water soluble and stable in water and adsorption to suspended solids a nd sediment has been observed to be low to high ( US

- EPA, 2000 ; HSDB, 2010 ) . Biodegradation occurs in water bodies with a half

- life greater than 64 days ( US

- EPA, 2000 )

. Although the EPA has determined that glufosinate use presents “no acute effects on terrestrial or ... aquatic plants”, EPA acknowledges potential impacts to non

- tar get plants either from runoff (aquatic) or spray drift (terrestrial) ( US

- EPA, 2007b )

. The US

- EPA has considered
non
- targ et plant communities in its environmental risk assessment of glufosinate use and has included label use restrictions and handling guidance inte nded to prevent impacts to mitigate potential impacts to aquatic and terrestrial plants ( see, e.g., Bayer, 2012 )

. Label restrictions specific to water resource s include, for example, prohibiting applications directly to water (except as allowed for rice), managing proper disposal of equipment wash water, and adopting cultivation methods (e.g., no till) to limit runoff to surface water, and not applying the herbicide when rainfall is forecasted to occur within 48 hours ( Bayer, 2012 )

. 86DRAFT PIONEER 4114 MAIZE

S pray drift , as discussed above in Subsection 4.3.3

– Air Quality , is a concern for non

- target plants growing proximate to fields when herbicides are used ( see, e.g., Sanvido et al., 2007 ) . The risk of off

- target glufosinate herbicide drift is recognized by the US

- EPA , which has incorporated both equipment and management restrictions to address drift in the approved herbicide labels ( US

- EPA, 2007b ; see Bayer, 2012 )

. Contact herbicides like glufosinate can case spotting on non

- target plants when spray droplets drift onto and impact leaf tissue, although total tissue death is uncommon unless the herbicide completely covers the leaf ( Ruhl et al., 2008 )

. The US

- EPA label for glufosinate addresses spray drift concerns with label language on spray droplet size, wind speeds, ambient temperature, avoidance of certain sensitive plants, and specific equipment requirements regarding boom length and height above the canopy ( Bayer, 2012 )

. For example, the label requires that the applica tor only use the herbicide when there is minimal “...potential for drift to adjacent sensitive areas (e.g. residential areas, bodies of water, known habitats of threatened or endangered species, non

- target crops) ... or in circumstances where drift to unprotec ted persons or to food, forage or other plantings ... can occur” ( Ba yer, 2012 )

. These label use conditions by the US

- EPA are intended to limit the potential impacts of glufosinate spray drift, and are not expected to change under the No Action Alternative. Under the No Action Alternative, there are numerous weeds in cor nfields and they may be controlled by current practices , as noted in Subsection 2.4.2

– Plant Communities. Additionally, herbicide

- resistant weed biotypes, namely glyphosate

- resistant weed biotypes may continue to occur under the No Action Alternative. The emergence of herbicide resistance is not a new occurrence ; n ew weeds may emerge as cropping practices change and growers fail to recognize or properly identify a plant as a weed ( Iowa State University Extension, 2003 )

. Although herbicide resistance in weeds was recognized long before GE crops were introduced, recent changes in grower practices to take advantage of these GE crops have impacted this phenomenon ( Owen et al., 2011a ) . The introduction of glyphosate

- r esistant crops, including corn, resulted in growers changing historical weed management strategies, substituting g lyphosate for other herbicides and relying on a single herbicide, glyphosate, to control weeds in the field ( Owen et al., 2011a ; Weirich et al., 2011 ; Vencill et al., 2012 ) . O v er
- reliance on glyphosate use as a single management technique for weed control resulted in the selection of weeds resistant to that technique ( Owen et al., 2011a ; W eirich et al., 2011 )

. The development of herbicide

- resistant weeds requires growers to diversify their weed managem ent strategies. Some growers, faced with glyphosate

- resistant weeds, have returned to tillage and other cultivation techniques to physically control these species when herbicides prove ineffective ( Pioneer, 2012 )

. Diversifying herbicide weed management strategies is an effective alternative to tillage for mitigating the evolution of weed resistance to herbicides ( Wilson, 2011 )

. An example of an additional herbicide that may be used to control glyphosate

- resistant weeds is glufosinate, though other herbicides are available for use in corn

. Table 4

- 3 illustrates t he comparative control of glyphosate

- resistant and hard to control weeds based on records of glyphosate resistance, and potential glufosinate control. Diversifying herbicide weed management strategies is an effective alternative to tillage for mitigating t he evolution of weed resistance to herbicides ( Wilson, 2011 )

.

87DRAFT PIONEER 4114 MAIZE

Table 4

- 3 . Comparative control of herbicide

- resistant we eds. ( IPM, 2007 ; Heap, 2012 )

Weed Species Hard to Control Glyphosate

resistant ALS

resistant Glufosinate controlled Abuti l on theophrasti (Velvetleaf) X Amaranthus palmeri (Palmer amaranth) 2 X X X Amaranthus rudis (Tall or common waterhemp) X X X Ambrosia artemisifolia (Common ragweed) X X X Ambrosia trifida (Giant ragweed) X X X Chenopodium album (common lambsquarters) X X Conyza canadensis (Marestail) X X X Eleusine indica (Goosegrass) X X X 4 Ipomoea sp. (Morningglory species) X Lolium multiflorum (Italian ryegrass) X X 3 X X 3 Lolium perenne (Perennial ryegrass) X X X X Lolium rigidum (Rigid ryegrass) X X X X Poa annua (Annual bluegrass) X X X Sida spinosa (Prickly sida, Teaweed) X X Solanum ptycanthum (Eastern black nightshade) X X Sorghum hal e pense (Johnsongrass) X X X Notes: 1. 2,4

- D application rate of 560 to 1,120 g ae/hectare. 2. Requires a broader management plan. 3. Reported in Heap as exhibiting resistance to both herbicides in Oregon. 4. Resistance to glufosinate reported in malaysia ( Heap, 2012 )

Globally, only two weeds have been identified as resistant to glufosinate: Lolium mult i florum (Italian ryegrass) and Eleusine indica (Goosegrass), with Lolium the only reported resistant weed in the United States ( Heap, 2012 ) . Th e Lolium species is a difficult to control weed in corn ( see, e.g., King e t al., 2012 )

. This species also has been reported as resistant to glyphosate in certain locations, and has exhibited resistance to both herbicides in an Oregon location ( Heap, 2012 )

. Control measures are available for this weed under the No Action Alternative, including the use of other herbicides, such as gramoxone and atrazine ( King et al., 2012 )

. Corn as a Weed or Volunteer
As discussed in Subsection 2.4.2

– Plant Communities , corn is not considered a weed in the United States ( Crockett , 1977 ; Muenscher, 1980 )

. Under the No Action Alternative, corn will remain non

- weedy.
Corn has been identified as a volunteer when corn seeds remain in the field after harvest and successfully ge rminate ( Beckett and Stoller, 1988 ; USDA

- APHIS, 2012e ) (see also Davis, 2009 ; Hager, 2009 ; Bernards et al., 2010 ; Johnson et al., 2010 ; Wilson et al., 2010 ; Stewart, 2011 ; Wilson, 2011 )

. The adoption of herbicide

- resistant crops has cha nged the approaches which growers can use to reduce crop losses from volunteers ( Beckie and Owen, 2007 )

. In soybean fields cultivated in rotation with corn where the volunteer corn is glyphosate

- or glufosinate

- resistant , herbicides with alternate modes of action might be employed (e.g., glufosinate in LibertyLink ® soybean to 88DRAFT PIONEER 4114 MAIZE

control a Roundup Ready ® glyphosate

- resistant volunteer corn variety ) ( Minnesota, 2009 ; Bernards et al., 2010 )

. Post

- emergent grass herbicide that function as ACCase inhibitors also are recommended, including q uizalofop, fluazifop, fenoxaprop, sethoxydim, and clethodim ( Hager, 2009 ; Bernards et al., 2010 ; Johnson et al., 2010 )

. ALS inhibitors, such as the sulfonylureas, i m i dazolinone , and triazoloyrimidine also have been identified for potential control of glyphosate

- or glufosinate

- resistant corn (see, Hager, 2009 ; Wisconsin, 2011 )

. Herbicide tank mix additives are recommended to increase on

- plant spray retention and absorption (see Hager and McGlamery, 1997 ; Sandell et al., 2009 ; Johnson et al., 2010 )

. Recommended additives include crop oil concentrate (COC), methylated seed oil (MSO), and ammonium sulfate (AMS) ( Hager and McGlamery, 1997 ; Johnson et al., 2010 ; Monsanto, 2010 )

. Imazethapyr has been identified to control up to 80% of the volunteer corn when the corn is still in early growth stages ( Bernards et al., 2010 )

. The ACCase inhibiting herbicides are to b e applied prior to the corn reaching the 12 to 24 inch tall stage and the ALS herbicides are effective in controlling smaller (2 to 8 inch ) corn ( Minnesota, 2009 ; Monsanto, 2010 )

. GE corn varieties, such as 1507, 59122, and the 1507 x 59122 Maize are currently cultivated in the United States . These GE corn varieties, like any other non

- GE or GE corn variety, possess the p otential to become volunteers. These GE corn varieties, like conventional corn varieties, may be controlled by mechanical cultivation as well as readily available herbicides or other graminicides ( Wozniak, 2002 ) . As discussed in Subsection 2.4.2.2

– Corn as a Weed or Volunteer , herbicides recommended for control of volunteer corn in soybeans and canola are the ACCase inhibitors and certain ALS inhibitors ( Hager, 2009 ; Gunsolus and Stachler, 2010 ; Gunsol us and Porter, 2011 )

. The ACCase inhibitors include two families of herbicides, the AOPP ACCases (e.g., the “fops,” such as quizalofop, fenoxaprop, and diclofop) and the cyclohexanediones (e.g., the “dims,” such as clethodim and sethoxydim) ( Hager, 2009 )

. Additionally, specific herbicide stra tegies to control corn volunteers in rotation with various crops are developed in consultation with local agronomists. For example, Gunsolus and Stachler ( 2004, Updated 2010 ) provide an overview of the various herbicide strategies recommended in North Dakota to control weeds in glyphosate

- resistant corn cultivated in rotation with a wide range of crops, including corn, soybean, sugar beet, wheat, potato and dry bean. Under the No Action Alternative, t hese currently

- available herbicides and strategies may control volunteer corn, such as volunteer cor n derived from 1507, 59122, and 1507 x 59122 Maize.
4.4.2.2 Preferred Alternative: Plants The potential impacts to plant communities from a determination of nonregulated status of Pioneer 4114 Maize relates to both the potential impacts of the cultivation of Pion eer 4114 Maize on other plant communities and the potential for this corn variety to become a weed or volunteer, thus interfering with other crop cultivation. These are addressed separately in the following subsections. Surrounding Landscapes and Other Ve getation in Cornfields Under the Preferred Alternative, a determination of nonregulated status of Pioneer 4114 Maize is not anticipated to substantially impact vegetation surrounding a cornfield. As discussed in Subsection 4.2

– Agricultural Production of Corn , Pioneer 4114 Maize does not require different 89DRAFT PIONEER 4114 MAIZE

agricultural management strategies from commercially

- available corn varieties, like 1507 x 59122 Maize , and is not expected to substantially affect the surround ing vegetation relative to the No Action Alt ernative

. As noted in the No Action Alternative , the US

- EPA has established label use restrictions to control runoff and spray drift during /following the application of glufosinate , including the application of glufosinate on 1507, 59122, and 1507 x 59122 Maize ( see, e.g., Bayer, 2012 )

. There are no changes to the application rates or label required to cultivate Pioneer 4114 Maize ( Pioneer, 2011b )

. Accordingly, the potential impacts to non

- targe t plants associated with off

- site herbicide movement under the Preferred Alternative are the same as the No Action Alternative

. The total volume of glufosinate used on corn has remained relatively steady in recent years, with 2% to 6% of the total corn acr eage treated with glufosinate between 2001 and 2011 ( Pioneer, 2012 )

. To the extent that growers may cultivate Pioneer 4114 Maize in lieu of currently

- available corn hybrid s with identical traits (i.e. glufosinate

- resistance and insect

- resistance) , such as 1507 x 59122 Maize, the total volume of is not expected to change

. There are no differences in this aspect under the Preferred Alternative compared to the No Action Altern ative with respect to plant communities surrounding a corn field

. The cultivation of Pioneer 4114 Maize is not expected to change weed management strategies already conducted by growers cultivating 1507 , 59122, and 1507 x 59122 Maize (see. e.g., ( De Schrijver et al., 2007 ) ) . These practices are consistent with those currently employed under the No Action Alternative to control weeds found within cornfields as well as those practices undertaken to protect plants located outside of the cornfield. Based on these findings, the p otential impacts from a determination of nonregulated status of Pioneer 4114 Maize to vegetation surrounding cornfields are not expected to differ from the No Action Alternative.
Corn as a Weed or Volunteer Agronomic studies conducted by Pioneer compared t he weediness potential of Pioneer 4114 Maize with conventional corn ( Pioneer, 2011b ; USDA

- APHIS, 2012e ) . No differences were detected between Pioneer 4114 Maize and conventional corn in dormancy, germination, growth, reproduc tion, or interactions with pests and diseases. Similarly , none of the characteristics of Pioneer 4114 Maize confer any additional advantage as a volunteer from GE corn varieties, such
as 1507 x 59122 Maize that are already commercially cultivated

. Accordi ngly, Pioneer 4114 Maize is not expected to be any weedier or to exhibit different volunteer traits than those described in the No Action Alternative . To the extent that Pioneer 4114 Maize does become a volunteer in other corn or rotation crops, the manage ment controls for this variety are expected to be similar to those currently used for control of 1507 x 59122 Maize volunteers as discussed in the No Action Alternative

. The well

- established and broadly used agricultural protocols to control volunteer corn associated with Pioneer 4114 Maize are consistent with the practices currently employed under the No Action Alternative. Accordingly, t he strategies to control potential volunteer 1507, 59122, and

90DRAFT PIONEER 4114 MAIZE

1507 x 59122 Maize are anticipated to be equally applicabl e to Pioneer 4114 Maize under the Preferred Alternative (De Schrivjer, 2007)

. Based on these findings, there are no anticipated differences in potential impacts between the N o A ction and the Preferred Alternative for plant communities.
4.4.3 Soil Microorganisms
In the cultivation of corn , p otential impacts to soil microorganisms can arise from the agronomic practices in cultivating corn and from exposure to the introduced gene, protein, and composition of the corn variety if it is GE

. 4.4.3.1 No Action Alternative: Soil Microorganisms Under the No Action Alternative, Pioneer 4114 Maize remains a regulated article. As discussed in Subsection 4.2.2

– Agronomic Practices, c orn cultivation practices are expected to remain as currently practiced. Growers will continue to have access to existing GE corn varieties (both lepidopteran

- resistant and herbicide

- resistant ) as well as conventional corn varieties. Corn varieties based on 1507, 59122, and 1507 x 59122, the foundation for Pioneer 4114 Maize, will still be available to gro wers. Growers will continue to manage their crops, including implementing numerous management strategies to control pests and weeds. As discussed in Subsection 4.2.2

– Agronomic Practices , these current practices include the use of glufosinate for the cont rol of certain weeds in the LibertyLink ® varieties. Under the No Action Alternative, soil microorganisms will continue being exposed to GE corn varieties, their introduced proteins, and the agronomic practices currently used to cultivate these GE corn vari eties. The cultivation of GE crops has not been demonstrated to present environmental risks to soil microbial populations ( Vencill et al., 2012 )

. The diversity of microbial populations may be affected by these crops, but effects reported to date have been transient and minor ( Dunfield and Germida, 2004 ; Vencill et al., 2012 )

. Although Bt occurs naturally in soil, growth of Bt corn may cause a large increase in the amount of Cry endotoxin present in agricultural systems ( Blackwood and Buyer, 2004 )

. M any studies have assessed the potential effects of Bt proteins on microbial biomass , community structure, community function , and enzymatic processes . T here is little evidence that soil microorganisms
or soil ecosystem level processes are negatively impacted by Bt proteins in soil or by the cultivation of GE crops ( Icoz and Stotzky, 2008 ) . Because of concerns of the potential impacts of cultivating GE crops with Bt proteins on soil communities, the decomposition rates of GE crops with Bt proteins versus non
- GE crops have been studied ( Icoz and Stotzky, 2008 )

. One study specifically characterized the potential effects of cultivating Cry1F

- and Cry1Ab

- expressing corn on microorganism community structure (assessed by shifts in phospholipid fatty acid profiles) or function (assessed through carbon substrate utilization profiles) in three different soil types ( Blackwood and Buyer, 2004 ) . Results from this study demonstrated that, und er laboratory conditions , the structure and function of microorganism communities were not affected by Cry1F
or Cry1Ab proteins. This is in contrast to some other studies examining the effect of Cry proteins on soil microorganisms ( US

- EPA, 2010b ; US

- EPA, 2010a ) . Howe ver, a s noted in Subsection
91DRAFT PIONEER 4114 MAIZE

4.3.1. 1

– No Action: Agronomic Practi c es , t he US

- EPA notes that many of the early experiments evaluating Cry persistence in soil were based on bulk soil, rather than soils representing field conditions ( US

- EPA, 2010b ; US

- EPA, 2010a ) . These bulk soil experiments did not represent realistic field conditions, including degradation pathways in soil ( US

- EPA, 2010b ; US

- EPA, 2010a ) . The US

- EPA expects that degradation rates under field conditions may be higher than bulk soil experiments would suggest ( US

- EPA, 2010b ; US

- EPA, 2010a ) . Additionally, although the US

- EPA found that the Cry proteins showed little degradation in soils with low pH (pH 5), the US

- EPA also noted that corn does not grow well below pH 5.6; therefore, under most production conditions, corn would not be grown on soils that would inhibit the rate of degradation ( US

- EPA, 2010b ; US

- EPA, 2010a )

. Similarly, the Cry proteins in currently

- cultivated Bt corn varieties, including 1507, 59122, and 1507 x 59122 Maize , have been examined , and were found to not have any substantial impacts on soil microorganisms ( USDA

- APHIS, 2001 ; USDA

- APHIS, 2005 ; US

- EPA, 2010b ; US

- EPA, 2010a ) . No short

- term or long

- term impacts to soil invertebrate populations exposed to Bt proteins have been i dentified as a result of the wide

- scale cultivation of Bt crops ( Sanvido et al., 2007 )

. Corn tissue degradation has been studied as a measure of potential impacts of Bt exudates on soil microorganism function. In one laboratory study , Bt corn tissue took longer to decompose than
non
- Bt c orn tissues ( Flores et al., 2005 ) ; however, other l aboratory based studies have demonstrated that there is no diffe rence between Bt and non
- Bt co rn decomposition rates ( Hopkins and Gregorich, 2003 ) . Studies conducted u nder field conditions show the decomposition rates of Bt cotton and Bt corn did not differ from the decomposition rates of non

Bt cotton and corn ( Lachnicht et al., 2004 ; Tarkalson et al., 2007 )

. Under the No Action Alternative, soil microorganisms are already exposed to the PAT protein contained in GE corn varieties no longer subject to the regulatory requirements of 340 Part 7 or the provisions of the Plant Protection Act of 2000. The PAT protein was evaluated in 1507 and 59122 M aize and is not expected to have any substantial impact on non

‐ target organisms, including soil m i croorganisms ( OECD, 1999 ; USDA

- APHIS, 2001 ; Hérouet et al., 2005 ; USDA

APHIS, 2005 ; CERA, 2011 )

. Under the No Action Alternative, microorganisms will continue to be exposed to glufosinate in U.S. cornfields. A s discussed in S ubsection 4.2.2

– Agronomic Practices, glufosinate is one of many herbicides applied on U.S. corn acres. Soil microbes rapidly degrade glufosinate to CO 2 and natural phosphorus compounds ( US

- EPA, 2008b ) . Glufos inate applications may impact soil microbe communities, although the reported research yields differing results (see, e.g., Gyamfi et al., 2002 ; Lupwayi et al., 2004 ; Wibawa et al., 2010 ) . For example, Gyamfi et al ( 2002 ) suggest that some of these microbial population shifts may be caused by the increase of herbicide

degrading microbes following application; whereas, other research suggests that glufosinate inhibits the activity of cultivar pathogens such as bacterial blight ( Pline, 1999 ) and grapevine downy mildew ( Plasmopara viticola ) ( Kortekamp, 2010 )

.

92DRAFT PIONEER 4114 MAIZE

4.4.3.2 Preferred Alternative: Soil Microorganisms Under the Preferred Alternative, soil microorganisms are unlikely to be substantially affected by a determination of nonregulated status of Pioneer 4114 Maize compared to the No Action Alte rnative. As discussed in Subsection 4.1

– Scope of the Environmental Analysis, Pioneer 4114 Maize is phenotypically identical to 1507 x 59122 Maize. Accordingly, soil microorganisms are already exposed to the cultivation practices and introduced proteins i n Pioneer 4114 Maize. There is no evidence that environmental effects caused by two parent genes in a stacked combination, will be any different than the effects caused by the two genes, cultivated separately ( De Schrijver et al., 2007 )

. As discussed in S ubsection 4.2.2

– Agronomic Practices , a determination of nonregulated status of Pioneer 4114 Maize is not expected to result in changes in corn agronomic practices. An example of this are the agronomic inputs associated with the cultivation of Pioneer 4114 Maize

. G rowers have the o ption to include glufosinate in their weed control strategies if they adopt Pioneer 4114 Maize . However, this change in weed management strategy is no different than that under the No Action Alternative, as corn varieties containing the same herbicide

- resi stant and insect

- resistant proteins as Pioneer 4114 Maize are already on the market (e.g., 1507, 59122, and 1507 x 59122 Maize)

. This means that soil microorganisms are already exposed to glufosinate and the Cry proteins in Pioneer 4114 Maize.
S oil microo rganisms rapidly degrade glufosinate to CO 2 and natural phosphorous compounds ( US

- EPA, 2008b )

. USDA

- APHIS does not anticipate that the use of glufosinate on Pioneer 4114 Maize will have an adverse impact on soil microorganisms. Accordingly, soil microorganisms will continue to experience typical corn agronomic practices and are not expected to be substantially impacted by agronomic practices used to cultivate Pioneer 4114 Maize.
The insect

- resistant and herbicide

- resistant event s contained by Pioneer 4114 Maize have been available commercially since 2006 with the development of the 1507 x 59122 variety ( Pioneer, 2012 ) . As noted in Table 4

- 1 , a number of commercial hybrids based on this variety are currently available. Soil microorganisms are already exposed to the Cry and PAT proteins from exudates as well as decomposing plant matter. Consequently, a determination of nonregulated status of P ioneer 4114 Maize is not expected to substantially change soil microorganism exposure currently experienced under the No Action Alternative. Additionally, because soil organisms are already being exposed to the introduced proteins in Pioneer 4114 Maize, no impacts to microorganisms are anticipated from a determination of nonregulated status of Pioneer 4114 Maize. Based on these factors, USDA

- APHIS does not anticipate substantial impacts to soil microorganisms under the Preferred Alternative . As the herbicid e glufosinate is registered currently for use on corn, and the traits expressed by Pioneer 4114 Maize are already commercially available, substantial differences between the No Action Alternative and the Preferred Alternative with regard to soil microorgan isms are unlikely

.

93DRAFT PIONEER 4114 MAIZE

4.4.4 Biological Diversity
4.4.4.1 No Action: Biological Diversity
As discussed in Subsection 2.4.4

– Biological Diversity , c urrently commercialized GE crops have reduced the impacts of agriculture on biodiversity through current use of conservation tillage practices , reduction of insecticide use, the use of more environmentally benign herbicides , and increasing yields to alleviate pressure to convert additional land into agricultural use ( Young and Ritz, 2000 ; Jasinski et al., 2003 ; Carpenter, 2011 )

. For GE crops, like corn, insecticide applications are substantial ly reduced with the cultivation of Bt varieties, which has been shown to contribute to natural enemy conservation, a substantial part of biodiversity in corn cultivation ( see, e.g., Romeis et al., 2006 )

. Under the No Action Alternative, Pioneer 4114 Maize will continue to be a regulated article. Grower s and other parties who are involved in production, handling, processing, or consumption of corn would continue to have access to existing nonregulated herbicide

- resistant corn varieties, pest

- resistant varieties, stacked varieties presenting both, and con ventional corn varieties. These currently available varieties include 1507, 59122, and 1507 x 59122 Maize , which con tains all of the traits of Pioneer 4114 Maize. The consequences of current agronomic practices associated with corn production , both traditi onal and GE varieties , on the biodiversity of plant and animal communities would likely not be altered. Cultivation of GE crops engineered to accumulate insecticidal proteins or tolerate herbicide application for weed management (including 1507, 59122, and 1507 x 59122 hybrid varieties already in cultivation) may influence local biodiversity, although distinguishing direct and indirect impacts of agronomic practices is difficult (see, e.g., Marshall et al., 2002 ; Ponsard et al., 2002 )

. For example, some studies have shown Bt proteins in GE crop exudates do not persist, but may degrade differently in different soil types ( Carpenter, 2011 ) . The difference in degradation appears to be primarily the resul t of differences in soil microbial activity, which in turn is dependent on soil type, season, crop species, crop management practices, and other environmental factors that vary with location and climate zones ( Carpenter, 2011 ) . These site

specific differences make it difficult to clearly demonstrate impacts to soil biodiversity across entire crop systems. In another example, reductions of biological control organisms are seen in
some Bt crops, but are caused by reduction of the pest host population following transgenic pesticide expression in the GE crop plant ( Naranjo, 2009 ) . A s discussed in Subsections 4.4.1

– Animal Communities , 4.4.2 Plant Otherwise Communities, and 4.4.3 Soil Microorganisms , there is no evidence that exposure to the Cry and PAT proteins in currently cultivated crops impacts animals, plants or soil microorganisms ; biodiversity of an agricultural setting is constituted by the presence of these organisms

. Adoption of Bt crops has been associated with a r eduction in the application of insecticides to control various insect pests ( Carpenter, 2011 ; Brookes and Barfoot, 2012 ; Brookes et al., 2012 )

. Such a reduction in insecticide applications would bring a corresponding posi tive impact to biodiversity ( Carpenter, 2011 )

.

94DRAFT PIONEER 4114 MAIZE

Although herbicide use potentially affects biodiversity, the application of pesticides in accordance with US

- EPA registered label uses and careful management of chemical spray drift minimizes the potential biodiversity i mpacts from their use. The US

- EPA has considered this in its registration and has established label use restrictions to minimize glufosinate drift ( see Bayer, 2012 )

. Glufosinate is deemed non

- toxic to birds, mammals, and insects; slightly non

- toxic to freshwater fish; moderately toxic to estua rine/marine fish; moderately toxic to freshwater and estuarine/marine invertebrates; and toxic to terrestrial and aquatic plants ( US

- EPA, 2008b )

. Glufosinate is already used in corn, including corn bas ed on the 1507, 59122 and the 1 507 x 59122 hybrid.
4.4.4.2 Preferred Alternative: Biological Diversity Pioneer has presented results of agronomic field trials comparing Pioneer 4114 Maize conventional corn . T he results suggest that there are no meaningful differences in agronomic attributes between Pioneer 4114 Maize and conventional corn ( Pioneer, 2011b ; Pioneer, 2012 )

. Therefore, a determination of nonregulated status of Pione er 4114 Maize is not expected to change agronomic practices. As noted in the introduction to this section , the commercial hybrid 1507 x 59122 Maize , the foundation for Pioneer 4114 Maize traits , has been cultivated commercially for many years with no repor ts of impacts to animal or plant communities. There is no evidence that environmental effects caused by two parent genes in a stacked combination, will be any different than the effects caused by the two genes, cultivated separately ( De Schrijver et al., 2007 )

. As discussed above in Su bsection 4.2

– Agricultural Production of Corn, Subsection 4.4.1

– Animal Communities, and Subsection 4.4.2

– Plant Communities, a determination of nonregulated status of Pioneer 4114 Maize will continue the use of glufosinate in U.S. corn. Glufosinate is already labeled for use in corn, and may be applied to any of the Liberty ® corn varieties. A change in label is not required to apply glufosinate to Pioneer 4114 Maize ( Pionee r, 2011b ) . Increases in glufosinate use are unlikely, as Pioneer 4114 Maize is anticipated to replace some 1507 x 59122 Maize plants that are already cultivate d as part of weed management strategy incorporating glufosinate. Animals, plants , and microor ganisms’ exposure to the Cry and PAT proteins in Pioneer 4114 Maize will be no different than exposure occurring under the No Action Alternative associated with cultivation of 1507, 59122 and the 1507 x 59122 Maize

. Similarly, animals, plants and microorga nisms associated with these fields are already exposed to glufosinate. As noted in Subsection 4.2 2

– Agricultural Production of Corn , Pioneer does not seek a change in the application or use of glufosinate for the cultivation of Pioneer 4114 Maize ( Pioneer, 2011b )

. Based on these findings, the potential impacts to biodiversity of plant and animal communities from the determination of nonregulated status of Pioneer 4114 Mai ze are similar to those from current conditions under the No Action Alternative

.

95DRAFT PIONEER 4114 MAIZE

4.4.5 Gene Movement Vertical gene flow, or introgression, is the movement of genes to sexually compatible relatives and their subsequent expression ( Ellstrand, 2003 ; Quist, 2010 ) . Horizontal gene transfer is the stable movement of genes from one organism to another without reproduction or human intervention ( Keese, 2008 ; Quist, 2010 )

. 4.4.5.1 Vertical Gene Flow

– Movement to Other Varieties and Corn Relatives
No Action

– Vertical Gene Flow Under the No Action Alternative, conventional and GE transgenic corn production will continue, including the current cultivation of 1507 59122 and 1507 x 59122 Maize

. The possibility of gene movement from cultivated corn varieties into native or feral populations of Zea species or wild or weedy relatives of corn has been evaluated by the US

- EPA and determined not to be a concern in the continental United States ( US

- EPA, 2010e )

. Vertical gene flow from currently cultivated corn varieties in the United States, including 1507, 59122, and 1507 x 59122 Maize varieties, to U.S. populations of Zea or Tripsacum species is not likely, with the limited exception of potential gene flow to feral populations of Zea mays ssp. parviglumis in Florida and to a less er extent, Tripsacum floridanum , also in Florida. Differences in flowering time between corn and these species, and current geographic separation of these species from the majority of U.S. corn production, make the occurrence of natural crosses in the U.S. very minor ( Galinat, 1988 ; Doebley, 1990, Doebley, 1990 #539 ; Baltazar et al., 2005 ; Kermicle and Evans, 2005 ; Ellstrand et al., 2007b )

. If hybridization were to occur, the resulting hybrids are often sterile or have greatly reduced fertility, the hybrids are less fit, do not disseminate seed, have a reduced reproductive capacity, and none can withstand even the mildest winters ( OECD, 2003 ; USDA

APHIS, 2012e )

. Additionally, hybridization betw een corn and Tripsacum is not likely in the absence of specialized hybridization techniques in controlled conditions, strongly suggesting that hybridization is unlikely in typical field conditions ( Mangelsdorf, 1974 ; Russell and Hallauer, 1980 ; Galinat, 1988 ) . Consequently, g ene flow between current commercially available corn cultivars and its relative s both GE and non

- GE (including those Tripsacum species listed in Subsection 2.4.5

– Gene Movement ) is unlikely under the No Action Alternative. Gene movement between sexually compatible corn varieties and related species is no greater for currently cultivated GE varieties, including 1507, 59122, and the 1507 x 59122 Maize than it is for other non

- GE or GE cultivars ( USDA

- APHIS, 2012e )

. Many factors limit the likelihood of gene movement between corn varieties, including those noted below.

• The pat gene does not impart an agronomic advantage whereby a greater potential for weediness or invasiveness would result should introgression occur

.

• Neither GE n or non
- GE corn cultivars form self

- sustaining populations outside of cultivation because of limitations in seed dispersal, germination, and seasonal requirements ( US

- EPA, 2010e )

.

96DRAFT PIONEER 4114 MAIZE

• Spatial and temporal isolation can be one of the most effective barriers to gene exchange between com crop cultivars ( Mallory

- Smith and Zapiola, 2008 ) . Current practices for maintaining the purity of hybrid seed production in corn ar e typically successful for maintaining 99% genetic purity, though higher instances of out crossing can occur ( Ireland et al., 2006 )

. The corn industry has measures in place as part of seed certification and varietal protection to restrict pollen movement and gene flow between c ornfields through the use of isolation distances, border and barrier rows, the staggering of planting dates, detasseling and hand pollination, and various seed handling, transportation and handling procedures ( see also, AOSCA, 2010 )

. The reproductive morphology of corn encourages cross
- pollination between corn plants and there is no evidence (genetic or biological barriers) to indicate that gene flow is inher ently restricted between GE and non

- GE corn

. Gene flow between corn varieties is most likely to occur during cultivation as well as the handling and processing of corn ( Thomison, 2009 ; Coulter et al., 2010 ; Mallory

- Smith and Sanchez

- Olguin, 2011 ) . Corn is a cross

- pollinating crop in which most pollination results from pollen dispersed by wind and gravity ( Thomison, 2009 ) . Factors controlling pollen

- mediated gene flow include the outcros sing rate of recipients, pollen loads of donors, pollen competition between donors and recipients, and local weather/climate conditions (e.g., wind, precipitation) ( Lu, 2008 ) . As discussed above in Subsection 4.2.3

– Organic Corn Farming and Specialty Corn Systems, growers concerned about cross pollination can incorporate standard management methods to control pollen drift in order to manage this form of gene flow. Gene flow through handling and processing is problematic if product handling facilities where corn is dried, cleaned, and stored do not maintain adequate separation between varieties ( Mallory

- Smith and Sanchez

- Olguin, 2011 )

. Such admixtures at these fac ilities have been reported for varieties of GE corn and conventional corn ( Mallory

- Smith and Sanchez

- Olguin, 2011 ) . This form of gene flow occurs irrespective of the variety of corn being cultivated, and is not a new concern associated with the determination of nonregulated status of this variety. As discusse d above in Subsection 4.2. 3

– Organic Corn Farming and Specialty Corn Production , procedures for managing identity of specific varieties are already in place to minimize gene flow challenges arising from admixtures during handling.
Vertical Gene Flow

– Pr eferred Alternative
As discussed in Subsection 4.2

– Agricultural Production of Corn , cultivation practices for Pioneer 4114 Maize are no different from those corn varieties currently cultivated under the No Action Alternative

. These corn varieties include 1507, 59122, and 1507 x 59122 Maize. Pioneer has compared the morphology of Pioneer 4114 Maize with other corn varieties, including 1507 and 1507 x 59122 Maize , and has identified no biologically meaningful differences in repro ductive biology ( Pioneer, 2011b ; Pioneer, 2012 ; USDA

- APHIS, 2012e )

. Accordingly, as compared to the No Action Alternative, there are no new management practices or reproductive characteristics that would affect the barriers to gene flow in corn. The management practices to mitigate vertical gene flow described in the No Action Alternative would be the same as tho se required under the Preferred Alternative (see, e.g., ( De Schrijver et al., 2007 ) )

. However, as discussed in Subsection 4.4.2

– Plant Communities , in the unlikely event that the pat gene from Pioneer 4114 Maize should pass to progeny through cross pollination, and the PAT herbicide 97DRAFT PIONEER 4114 MAIZE

resistance protein is expressed in that cross

- pollinated hybrid, and that hybrid becomes a volunteer, that volunteer could still be controlled by other readily available herbicides. Based on these findings, there are no substantial differences in Vertical Gene flow between the No Action Alternative and the Preferred Alternative following a determination of nonregulated status of Pioneer 4114 Maize.
4.4.5.2 Horizontal Gene Transfer

– Movement to Unrelated Species
Horizontal Gene Transfer

– No Action Alternative
As discussed in Subsection 2.4.5

– Gene Movement , there is no evidence of naturally occurring transgene movement from transgenic crops to sexually incompatible species ( USDA

- APHIS, 2012e )

. Horizontal gene transfer and consequent expression of DNA f rom one plant to another plant or other phyla (e.g., species of bacteria) are both unlikely to occur ( Keese, 2008 ) . This event would require physical relocation of the complete genetic material from the transgenic plant to the new location, including not only the genes which code for the production o f specific proteins, but also those portions of the genome which regulate the activity of those genes ( Keese, 2008 ) . There are no known naturally occurring vectors (such as plasmids, phages, or transposable elements) that could be responsible for inter

- domain gene transfer, and there is little eviden ce that eukaryotic cells are naturally capable of stably incorporating genes from the environment into their genome ( Brown, 2003 )

. Although viruses do move genetic material, all viruses that infect higher plants have small ribonucleic acid ( RNA ) or DNA genomes, usually with fewer than 20 encoded proteins ( Keese, 2008 ) . These viruses are therefore constrained as to the type and size of novel genetic material which can be acquire d by horizontal gene transfer ( Keese, 2008 )

. Two soil bacteria l species commonly associated with plants, Agrobacterium and Rhizobium, have been evaluated to determine the probability of horizontal gene transfer between the bacterium and its host plants. Agrobacterium moves its genes from its bacteri al plasmid to the plant, causing the plant to produce crown gall (abnormal outgrowth) ( University o f Illinois, 2010 )

. Rhizobium aids in nitrogen fixation in legume nodules ( Wilkinson and Elevitch, 2011 )

. The genomes of both bacteria have been sequenced, and the sequenced genes evaluated for exogenous genes ( Kaneko et al., 2000 ; Wood et al., 2001 ; Kaneko et al., 2002 ) . Despite what would appear to be millennia of symbiotic relationships between these bacteria and their host plants, there is no evidence that these organisms contain genes derived from plants; in cases where review of sequence data implied that horizontal gene transfer occurred, these events are inferred to ha ve occur ed on an evolutionary time scale in the order of millions of years ( Koonin et al., 2001 ; Brown, 2003 ) . Transgene DNA promoters and coding sequences are optimized for plant expression, not bacterial expression. Horizontal gene transfer, resulting in the relocation of entire transgenes including the regulatory portions of the DNA (those parts of the DNA which code for the production of the specific proteins in that relocated transgene) never has been shown to occur in nature ( Clarke, 2007 ; Stewart, 2008 ) . Thus, even if horizontal gene transfer occurred, proteins associated with these transgenes are not likely to be produced in the new host organism.

98DRAFT PIONEER 4114 MAIZE

Horizontal gene transfer may also occur within organisms of the same Kingdom. Ho rizontal gene transfer has been implicated in the incorporation of a specific genetic sequence in the parasitic plant purple witchweed ( Striga hermonthica ) , which infests cereal fields including corn and sorghum ( Sorghum bicolor ) ( Yoshida et al., 2010 ) . Yoshida concluded that the incorporation of the specific genetic sequence (with an unknown function) occurred between sorghum and purple witchweed before speciation of purple witchweed ( S. hermonthica ) and related cowpea witchweed ( S. gesnerioides ), a parasitic plant of dicots, from their common ancestor. In other words, horizontal gene transfer between a parasitic plant and its host is an extremely rare event and like potential horizontal gene transfer events between plants and bacteria, normally occurs over very large time scales. F urthermore, S. hermonthica is not found in the United States and S. asiatica (another related parasite of cereal crops) is only present in North Carolina and South Carolina ( USDA

- NRCS, 2011b ) . The Striga that occurs in the United States is listed as a Federal noxious weed, and is restricted in its distribution

- largely due to an USDA

- APHIS containment, quarantine, and eradication program ( Nickrent and Musselman, 2004, Updated 2010 available at http://www.apsnet.org/edcenter/intropp/pathogengroups/pages/parasiticplants.aspx )

. Horizontal Ge ne Transfer

– Preferred Alternative Pioneer has evaluated the morphological and compositional characteristics of Pioneer 4114 Maize with the 1507 and 1507 x 59122 Maize , and has determined that any differences are not biologically meaningful ( Pioneer, 2011b ; Pioneer, 2012 ; USDA

- APHIS, 2012e )

. The characteristics of Pioneer 4114 Maize are phenotypically identical t o corn varieties already cultivated , including 1507 x 59122 Maize

. Under the Preferred Alternative, t here are no changes in Pioneer 4114 Maize that would impact the barriers to horizontal gene transfer compared to the No Action Alternative.
Based on the f indings noted in the No Action Alternative , USDA

- APHIS considers the horizontal gene transfer from Pioneer 4114 Maize to unrelated species to be unlikely under the Preferred Alternative , and the same as potential horizontal gene transfer from existing GE a nd
non
- GE corn varieties (see, e.g., De Schrivjer, 2007)

. 4.5 PUBLIC HEATH
4.5.1 Human Health The assessment of potential human health effects from GE crops considers two aspects of the crop: the introduction of an herbicide when the crop contains an herbicide

- resistant trait, and potential changes in crop composition associated with newly introduced proteins. This subsection provides a summary of this analysis , with discu ssion of farm worker safety in S ubsection 4.5.2

. As noted in Subsection 4.1

– Scope of the Environmental Analysis , the introduced proteins in Pioneer 4114 Maize , notably Cry1F, Cry34Ab1, Cry35Ab1, and PAT, have been previously reviewed, and corn varieties containing these events are already widely cultivated. Moreover, there are several previou s assessments of the indirect effects associated with the exposure to glufosinate. Humans are already likely exposed to the agronomic practices related to Pioneer
99DRAFT PIONEER 4114 MAIZE

4114 M aize and the introduced proteins in Pioneer 4114 Maize . Accordingly, to facilitate the review of this section, and to reduce redundancy, these impacts are discussed in the context of the No Action Alternative.
4.5.1.1 No Action: Human Health Under the No Action Alternative, Pioneer 4114 Maize would remain a regulated article and would not be widel y cultivated in the United States

. However, h uman exposure to the agronomic practices associated with Pioneer 4114 Maize and its introduced proteins would not change

. Growers already cultivate GE maize varieties that contain the Cry1F, Cry34Ab1, Cry35Ab1 a nd PAT proteins (e.g., 1507, 59122, and 1507 x 59122 Maize varieties) , meaning that humans will continue to be exposed to those proteins

. The Cry1F protein and its associated genetic elements were introduced with 1507 Maize , which had a determination of no nregulated status by USDA, registered by the EPA , and reviewed by the US

- FDA in 2001 ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- EPA, 2010f ; Pioneer, 2011b )

. The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements were introduced in 59122 Maize, which was reviewed by US

FDA in 2004, had a determination of nonregulated status by USDA in 2005, and registered by US

- EPA since 2005 ( US

- FDA, 2004 ; USDA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 2011b )

. Maize expressing the PAT protein has had a nonregulated status since 1995 and commercially cultivated in the United States since 1996 ( USDA

- APHIS, 1995 )

. Maize varieties based on 1507, 59122, and 1507 x 59122 Maize are anticipated to still be cultivated. As noted previously in Subsection 4.2.2

– Agronomic Practices, in 2010 , approximately 16% of the commercial corn acreage was planted with a 1507 x 59122 Maize ( Pioneer, 2011b )

. With regard to glufosinate use on corn, in 2010, approximately 2% of the total corn acreage was treated with glufosinate ( USDA

- NASS, 2011a )

. Consumers would continue to be exposed to glufosinate and its residues on those corn acres treated with that herbicide, and
consumers also will be exposed to the same Cry proteins incorporated within the Pioneer 4114 Maize.
USDA

- APHIS ’ evaluation of potential human health effects considers potential impacts associated with incidental exposure to the pesticides applied to the GE crop and an analysis of the crop composition associated with the GE agricultural crop. USDA

- APHIS c onsiders the US

EPA and the US

- FDA regulatory assessments when evaluating these aspects of potential impacts to human health. Glufosinate Use and Exposure
USDA

- APHIS considers the US

- EPA ’s registration of pesticides when evaluating the potential consequen ces arising from a determination of nonregulated status of a GE crop. The US

- EPA considers human health effects from the use of pesticides when it evaluates the registration of pesticides. Prior to pesticide registration, including the new use of a previou sly

- registered pesticide, US

- EPA must determine that the pesticide will not cause unreasonable adverse effects on human health (and the environment, and non

- target species). Frequently, the US

- EPA will establish label restrictions to mitigate or alleviate any potential impact on human health and the environment. Once registered, a pesticide may not legally be used unless the use is consistent
100DRAFT PIONEER 4114 MAIZE

with the guidelines and application restrictions and precautions on the pesticide's label. The pesticide registratio n label is intended to provide appropriate use instructions so as to protect human health. US

- EPA uses the standard of “no unreasonable adverse effects” in making its registration determinations. FIFRA defines this term as follows

— UNREASONABLE ADVERSE EF FECTS ON THE ENVIRONMENT

— The term ‘‘unreasonable adverse effects on the environment’’ means (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, o r (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) ...(See; FIFRA, Section 2(bb), 7 U.S.C. §136(bb)) EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in place for all populations of non

- target species potentially exposed to pesticides, including humans. This risk assessment included acute, short

- term and chronic ag gregate risk assessments as well as occupational and residential exposure risk assessments. The US

- EPA is currently collecting and reviewing data supporting a reevaluation of the “acute and/or chronic dietary analysis” as part of its registration review of glufosinate ( US

- EPA, 2008a )

. These assessments provide US

- EPA with information needed to develop label use restrictions for the pesticide. G rowers are required to use pesticides such as glufosinate ammonium consistent with the application instruct ions provided on the US

- EPA

- approved pesticide label ( Bayer, 2012 )

. These label restrictions carry the weight of law and are enforced by US

- EPA and the states ( FIFRA 7 USC 136j (a)(2)(G) Unlawful Acts).
As discussed in Subsection 2.2.2.3

– Agronomic Inputs , the use of glufosinate on total corn a cres has remained stable and low over the past decade, with between 2% and 6% of the total U.S. corn acreage treated with glufosinate ( Pioneer, 2011b )

. This includes applic ation of glufosinate on GE maize varieties already containing the glufosinate

- resistant trait, such as 1507 x 59122 Maize. Additionally, as noted above, corn expressing the PAT protein and resistant to glufosinate has been commercially available since 1996 . The application of glufosinate to corn is not a new practice

. Under the No Action Alternative, the application of glufosinate to corn acreage is expected to follow U.S. corn growers’ adoption of glufosinate

- resistant corn varieties, such as 1507, 59122, or 1507 x 59122 Maize

. As glufosinate is currently applied to some U.S. corn acreage, glufosinate residue may occur on some U.S. corn grains . As noted in Subsection 1.3

– Coordinated Framework Review and Regulatory Review , before allowing the use of a pesticide on food crops, the US

- EPA sets a tolerance, or maximum residue limit, for the amount of pesticide residue allowed to remain on or in each treated food commodity ( US

- EPA, 2012f )

. US

- EPA is required to reach a safety determination based on a finding of reasonable certainty of no harm under th e FFDCA. To make this finding, US

- EPA considers the toxicity of the pesticide and its breakdown products, how much pesticide is applied and the frequency of application, and how much pesticide remains on the food by the time it is marketed and prepared ( US

- EPA, 2012f ) . The US

- EPA has established 101DRAFT PIONEER 4114 MAIZE

exem ptions for tolerance for glufosinate ( US

- EPA, 2010d ) . The US

- EPA ’s tolerance exemptions for glufosinate in corn are 6.0 parts per million (ppm) for corn stover, 4.0 ppm for corn forage, and 0.20 ppm for corn grain ( US

- EPA, 2010d )

. The establishment of these glufosinate tolerances by the US

- EPA ensure safety of foods treated with glufosinate and are made following risk assessments that reflect real

- world consumer exposure as closely as possible ( US

- EPA, 2012e )

. Additionally, t he processing of corn

- based food products , including those derived from corn varieties treated with glufosinate, has been demonstrated to reduce pesticide residues below the level of detection , reducing the exposure levels to the general U.S. population ( CRA, 2000 ) . In 1998, the USDA evaluated pesticide residues in high

- fructose corn syrup, milk, vegetables, and fruits ( USDA

- AMS, 1998 ) . Corn syrup samples were collected from 40 states and analyzed for 109 pesticides; no pesticide residues were detected in any of the corn syrup samples ( USDA

AMS, 1998 )

. Composition of Maize: Introduced Proteins Human exposure to Cry1F, Cry34Ab1, Cry 35Ab1, and PAT proteins has been reviewed by the USDA, the US

- EPA and the US

- FDA in the regulatory assessments , as cited in Subsection 4.1

– Scope of the Environmental Analysis . These event traits have been commercially cultivated for many years in 1507, 5 9122, and 1507 x 59122 Maize.
As discussed in Subsections 1.3

– Coordinated Framework Review and Regulatory Review and 2.5 Public Health , the US

- EPA ’s role in review of GE crops includes review of any introduced Cry proteins as PIP s under their FIFRA authority, and exemptions from tolerance for residues of pesticides on and in food and animal feed under its FFDCA authority. The Cry1F protein and its associated genetic elements had a determination of nonregulated status by USDA, was registered by the EPA , and was reviewed by the US

- FDA in 2001 ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- EPA, 2010f ; Pioneer, 2011b ) . The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements was reviewed by US

- FDA in 2004, had a determination of nonregulated status by USDA in 2005, and was registered by US

- EPA in 2005 ( US

- FDA, 2004 ; USDA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 2011b ) . Maize expressing the PAT protein has had a nonregulated stat us since 1995 and commercially cultivated in the United States since 1996 ( USDA

- APHIS, 1995 )

. The U S

- EPA has published exemptions from tolerance 27 for these proteins ( US

- EPA, 2007a ) . There are no reports of human health effects associated with exposure to Bt or PAT proteins, or the 1507, 59122 or 15 07 x 59122 Maize

.

27 As discussed in Subsection 1.3, the US

- EPA, pursuant to its authority under the FFDCA, sets tolerances for the maximum residues of pesticides on and in food and animal feed, or establishes an exempt ion from the requirement of tolerance, to reach a safety determination based on a finding of reasonable certainty of no harm from the potential exposure. To establish tolerance values, the US

- EPA considers the toxicity of the pesticide and its breakdown pr oducts, the frequency of pesticide application and volume applied, and the amount of residue remaining in or on the food at the time it is marketed and prepared. Some pesticides are exempted from tolerance where the exemption is found to be safe. For addit ional details, see http://www.epa.gov/pesticides/factsheets/stprf.htm

. 102DRAFT PIONEER 4114 MAIZE

The Cry1F, Cry34Ab1, and Cry35Abl proteins incorporated into 1507 and 59122 Maize were derived from Bt , a common bacterium, naturally occurring in soil, dust, insects, and leaves ( McClintock et al., 1995 ; Schnepf et al., 1998 ; US

- EPA, 1998 )

. Bt is not a known human pathogen ( US

- EPA, 1998 ) . Some strains of Bt have been shown to be opportunistic pathogens; however, this pathogenicity was not related to the Bt proteins ( Hernandez et al., 1999 )

. Bt microbial preparations containing Cry proteins have been used safely as pesticide sprays for decades, and have been deemed to pose no toxic effects to mammals ( US

- EPA, 1998 ; USDA

- FS, 200 4 ) . These proteins have been present in commercial corn varieties such as 1507, 59122, and/or 1507 x 59122 Maize since 2003, 2006, and 2006, respectively ( Pioneer, 2012 ) . The incorporation of Bt proteins in corn has resulted in a decrease in the application of insecticides for the control of lepidopteran and coleopteran pests , an indirect benefit to human health ( Brookes and Barfoot, 2010 )

. The PAT protein incorporated into 1507 and 59122 Maiz e is derived from S. viridochromogenes , a common soil bacterium ( Pioneer, 2012 ) . The PAT protein has a safe history of exposure in humans, animals, and the environment. S. viridochromogenes is widespread in soil and is not associated with human, animal, or plant pathogens ( Hérouet et al., 2005 ) . Related PAT proteins are found in at least six other species of common soil bacteria, none of which have been reported as toxic or allergenic to humans or animals ( Hérouet et al., 2005 ) . As noted in Subsection 2.2

– Agricultural Production of Corn , the PAT protein has been present in commercial corn, as well as other crops, since 1996. Cry1F , Cry34Ab1, Cry35Ab1, and PAT proteins have previously been reviewed for potential allergenicity and toxicity, and have been determined to have no amino acid sequence similar to known allergens, lacked toxic potential to mammals, and are degraded rapidly a nd completely in gastric fluid. ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- FDA, 2004 ; USDA

- APHIS, 2005 ; US

EPA, 2010f ; Pioneer, 2011b )

. Current human exposure to these Cry and PAT proteins has been determined to present no human health risk under the No Actio n Alternative

. Additionally, a s discussed in Subsection 2.5

– Public Health , human food products manufactured from feed corn are subjected to a variety of mechanical and chemical processes to produce the final product, each step of which tends to disrupt protein integrity ( Hammond and Jez, 2011 )

. These processes suggest that human exposure to the Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins in corn will be limited under the No Action Alternative

. Additionally, also noted in Subsection 2.5

– Publi c Health , the accumulation of the Cry proteins in GE corn plants provides an additional indirect benefit to human health, in that the control of certain insect pests of corn results in a lower incidence of fungal infection and mycotoxin formation ( Munkvold and Hellmich, 1999 ; Munkvold and Hellmich, 2000 ; Vincelli and Parker, 2002 ; US

- EPA, 2010b ; US

- EPA, 2010a )

. These benefits already accrue from the widespread adoption of corn varieties containing these Cry proteins, including 1507 and 59122 Maize which are already in the market.

103DRAFT PIONEER 4114 MAIZE

4.5.1.2 Preferred Alternative: Human Health
Under the Preferred Alt ernative, potential impacts to human health are not anticipated to be substantially different than under the No Action Alternative. As discussed in Subsection 4.1

– Scope of the Environmental Analysis, Pioneer 4114 Maize contains the same genetic elements a s 1507, 59122, and 1507 x 59122 Maize; accordingly, Pioneer 4114 Maize is phenotypically identical to 1507 x 59122 Maize (see, e.g., ( De Schrijver et al., 2007 ) )

. The human health effects of the cultivation of the Pioneer 4114 Maize are expected to be identical to those already evalua ted and described for 1507, 59122 , and 1507 x 59122 Maize. Public health concerns surrounding GE crops, like Pioneer 4114 Maize, are generally related to consumption of the GE crop itself. Pioneer 4114 Maize contains the Cry1F, Cry34Ab1, Cry35Ab1, and PAT proteins. Pioneer 4114 Maize also is likely to be sprayed with glufosinate if it is commercialized following a determination of nonregulated status. I t is expected that glufosinate use on the Pioneer 4114 Maize would be consistent with the US

- EPA

- approved label. Glufosinate Use and Exposure As discussed in the No Action Alternative, glufosinate is already used in U.S. corn production, meaning that the general population may already be exposed to glufosinate or its residues on corn grain.
A determination of nonregulated status of Pioneer 4114 Maize is not likely to change the herbicide use patterns for glufosinate in U.S. corn production . There are no proposed label changes for glufosinate use associated with the cultivation of Pioneer 4114 Maize ( Pioneer, 2011b ) .The per acre volume of glufosinate will not increase over currently approved label rates ( Pioneer, 2011b )

. As discussed in Subsection 4.2 .2

– Agronomic Practices, a grower adopting Pioneer 4114 Maize varieties would potentially substitute Pioneer 4114 for 1507 x 59122 Maize

. Moreover, growers are highly likely to substitute glufosinate for other herbicides ( Towery and W erblow, 2010 ) . The US

- EPA has determined that glufosinate does not present a human health impact when applied in accordance with label restrictions ( US

- EPA, 2003 ) . As there are no changes in application rates or total applications for Pioneer 4114 Maize, pesticide residue tolerances are not expected to change. Accordingly, a determination of nonregulated status for Pioneer 4114 Maize is not expected to substantially impact human health with respect glufosinate or its residues on corn grain, relative to the No Action Alternative

. Composition of Pioneer 4114 Maiz e: Expressed Proteins The traits expressed in Pioneer 4114 Maize have been commercially cultivated for many years. The introduced Cry and PAT proteins in Pioneer 4114 Maize are identical to the Cry and PAT proteins previously reviewed by the US

- EPA , US

- FDA , and USDA for 1507, 59122 and 1507 x 59122 Maize varieties that are currently cultivated and presented in the No Action analysis

. The Cry1F protein and its associated genetic elements are identical to those in 1507 Maize ; t he binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements are 104DRAFT PIONEER 4114 MAIZE

identical to those in 59122 Maize ; m aize expressing the PAT protein has had a nonregulated status since 1995 and commercially cultivated in the United States since 1996 ( USDA

- APHIS, 1995 )

. Pioneer has compared Pioneer 4114 with the foundation varieties, and has found no biologically meaningful dif ferences in the accumulation of these proteins or composition of the corn plants ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. Consequently, the health impacts of Pioneer 4114 Maize is unlikely to be substantially different than the health impacts of 1507, 59122, or 1507 x 59122 Maize varieties described in the No Action Alternative. Pioneer conducted safety evaluations based on Codex Alimentarius Commission procedures to assess any potential adverse effects to humans or animals resul ting from environmental releases and consumption of Pioneer 4114 Maize ( FAO, 2009 ; Pioneer, 2011b ; US

- FDA, 2011 ) . These safety studies included evaluating protein structure and function, including homology searches of the amino acid sequences with comparison to all known allergens a nd toxins ( Pioneer, 2011b )

. The Cry and PAT proteins expressed in Pioneer 4114 Maize have previously been reviewed for potential allergenicity and toxicity, and have been d etermined to have no amino acid sequence similar to known allergens, lacked toxic potential to mammals, and are degraded rapidly and completely in gastric fluid ( Pioneer, 2011 b )

. Pioneer has compared the compositional characteristics of Pioneer 4114 Maize with the near isoline and reference maize hybrids ( Pioneer, 2011b ) . Composition characteristics evaluated in these comparative tests include moisture, protein, fat, carbohydrates, ash, minerals, dietary fiber, essential and non

- essential amino acids, fatty acids, vitamins, and anti

- nutrients ( OECD, 2002 ; Pioneer, 2011b ) . A comprehensive comparison of Pioneer 4114 Maize with the near isoline variety showed no biologically meaningful differences for com position ( Pioneer, 2011b ; USDA

APHIS, 2012e )

. Pioneer submitted a Voluntary Consultation to the US

- FDA for this product on 22 December 2011 . FDA completed its evaluation on March 25, 2013 . As noted above, Pioneer 4114 Maize proteins have been present in commercial corn varieties such as 1507, 59122, and 1507 x 59122 Maize since 2003, 2006, and 2006, respectively ( Pioneer, 2012 ) . There are no reports of adverse effects to human health from the consumption of these corn varieties. Corn varieties based on these three lines are already in the commercial market. Additionally, the proteins in Pioneer 4114 Maize are rapidly degraded by gastric fluid s, further limiting human exposure to the proteins expressed by this corn variety

. Based on these factors, including an analysis of field and laboratory data related to Pioneer 4114 Maize ( Pioneer, 2011b ) , safety data available on other GE corn varieties , and the identical phenotypes of Pioneer 4114 Maize to the currently

- cultivated 1507 x 59122 maize, USDA

APHIS has concluded that a determination of nonregulated status of Pioneer 4114 Maize is unlikely to present an adverse impact on human health. Overall impacts on human health are similar to those expected for the No Action Alternative.
4.5.2 Worker Safety EPA’s WPS (40 CFR Part 170) was published in 1992 to require actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS
105DRAFT PIONEER 4114 MAIZE

contains requirements for pesticide safety training, notification of pesticide applica tions, use of personal protective equipment, restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance.
4.5.2.1 No Action: Worker Safety During agricultural production of corn, agricultural workers and pesticide applicators may be exposed to a variety of US

- EPA

- registered pesticides. Under the No Action Alternative, agricultural workers and pesticide applicators may be exposed to the herbicide glufosinate which is labeled for use on corn. The 2003 US

- EP A registration for glufosinate evaluated occupational exposures, including short

- term inhalation and dermal exposure estimates ( US

- EPA, 2003 ; US

EPA, 2008a ) . In this review, the US

- EPA co ncluded that occupational exposures were below the US

- EPA ’s level of concern ( US

- EPA, 2003 ; US

- EPA, 2008a )

. Maize varieties based on 1507, 59122, and 1507 x 59122 Maize are anticipated to still be cultivated. As noted previously in Subsection 4.2.2

– Agronomic Practices, in 2010, approximately 16% of the commercial corn acreage was planted with a 1507 x 59122 Maize ( Pioneer, 2011b )

. With regard to glufosinate use on corn, in 2010, approximately 2% of the total corn acreage was treated with glufosinate ( USDA

- NASS, 2011a )

. Agricultural workers would continue to be exposed to glufosinate and its residues on those corn acres treated with tha t herbicide

. As discussed in Subsection 4.5.1

– Human Health , US

- EPA ’s pesticide registration labels establish use restrictions for the pesticide. G rowers are required to use pesticides such as glufosinate ammonium consistent with the application instruct ions provided on the US

- EPA

approved pesticide label ( Bayer, 2012 )

. These label restrictions carry the weight of law and are enforced by US

- EPA and the states ( FIFRA 7 USC 136j (a)(2)(G) Unlawful Acts). The current label for glufosinate includes guidance and label use restrictions intended to protect agricultural workers , including protective equipment to be worn during mixing, loading, applications and handling, equipment specifications to control pesticide application, and reentry periods establishing a safe duration between pesticide application and exposure to the pesticide in the field ( Bayer, 2012 ) . Used in accordance with the label, glufosinate has been determined to not present a health risk to humans ( US

- EPA, 2008b ) . Appendix B provides a copy of a sample glufosinate label.
As discussed in Agricultural Production of Corn ( Subsections 2.2 and 4.2 ) , in 2010, 16% of the corn acreage was cultivated in 1507, 59122, or 1507 x 59122 Maize ( Pioneer, 2011b ) . Growers cultivating these varieties are already exposed to glufosinate and the Cry and PAT proteins. In 2 010, corn growers applied glufosinate to 2% of the total acreage of corn cultivated ( USDA

NASS, 2011a )

. 4.5.2.2 Preferred Alternative: Worker Safety Under the Preferred Alternative, no substantial impacts to worker safety are anticipated compared to the No Action Alternative. Glufosinate is currently registered for use on corn ( see,
106DRAFT PIONEER 4114 MAIZE

e.g., Bayer, 2012 ) , including 1507, 59122, and 1507 x 59122 Maize

. Similar to the No Action Alternative, it is expected that US

- EPA registered pesticides that currently are used for corn production will continue to be us ed by growers, including the use of glufosinate. Pioneer 4114 Maize is not expected to change the application rates of glufosinate on corn, and a label change is not required ( Pioneer, 2011b )

. Worker exposure to glufosinate under the Preferred Alternative is not expected to be substantially different than that already experienced under the No Action Alternative , as Pioneer 4114 Maize is anticipated to be cultivated in lieu o f 1507 x 59122 Maize in the United States

. Based on the above information, the potential impacts to worker safety from a determination of nonregulated status of Pioneer 4114 Maize under the Preferred Alternative are the same as those under the No Action A lternative.
4.6 ANIMAL FEED Corn comprises approximately 95% of the total feed grain produced and used in the United States ( USDA

- ERS, 2011d ) . Animal feed derived from corn comes not only from the unprocessed grain, but also from the residuals derived from three major corn industries: corn refining, corn dry millers, and distillers ( CRA, 2006 ) . Animal feed products from corn refining and wet milling include corn gluten feed, corn gluten meal, corn germ meal, corn steep liquor, and amino acids ( CRA, 2006 )

. As with human health, animal consumption of G E is a concern expressed by some individuals

. This includes consumption of GE corn material as feed and the consumption of any herbic ide or herbicide residues that may remain on the plant material after processing for animal feed.
4.6.1 No Action: Animal Feed Under the No Action Alternative, Pioneer 4114 Maize will remain a regulated product and will not be available as an animal feed. However, c orn
- based animal feed will still be available from currently cultivated corn crops, such as 1507, 59122, and 1507 x 59122 Maize. Consequently, the Cry and PAT proteins contained within 1507, 59122, and 1507 x 59122 Maize will continue to be prese nt in U.S. corn production and thus be present in animal feed. This includes Cry1F ( 1507 Maize ), Cry 34Ab1 and Cry35Ab1 (59122 Maize), and any hybrid containing the 1507 x 59122 cross. This means that under the No Action Alternative, the introduced protein s in Pioneer 4114 Maize may continue to be present in animal feed in the U nited States through the continued cultivation of 1507, 59122, and 1507 x 59122 Maize.
As discussed in S ubs ection 4.5

– Public Health , the US

- EPA and the US

- FDA have already reviewed the animal feed safety of the introduced proteins in 1507, 59122, and 1507 x 59122 Maize

. These Cry and PAT proteins have previously been reviewed for potential allergenicity and toxicity, and have been determined to have no amino ac id sequence similar to known allergens, lacked toxic potential to mammals, and are degraded rapidly and completely in gastric fluid ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- FDA, 2004 ; US DA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 2011b )

. Under the No Action Alt ernative, c urrent exposure to these Cry and PAT proteins has been determined to present no animal feed risk. Additionally, a s discussed in
107DRAFT PIONEER 4114 MAIZE

Subsection 4.5 .1.1

– Human Health , tolerances have been published for glufosinate and the introduced proteins in 1507, 59122, and 1507 x 59122 Maize ( US

- EPA, 2007a ; US

- EPA, 2010d )

. Under the No Action Alternative , animals may continue to be exposed to 1507, 59122, and 1507 x 59122 Maize and Cry1F, Cry34Ab1, Cry 35Ab1, PAT, and glufosinate through animal feed in the United States

. 4.6.2 Preferred Alternative: Animal Feed Under the Preferred Alternative, it i s unlikely that a determination of nonregulated status of Pioneer 4114 Maize will result in substantial impacts to animal feed compared to the No Action Alternative. The results of studies conducted by Pioneer confirm that there are no differences in feed safety between the Pioneer 4114 Maize and other varieties currently available under the No Action Alternative ( Pioneer, 2011b )

. As discussed in the analysis of the No Actio n Alternative, animal feed likely already contains the introduced proteins in Pioneer 4114 Maize and glufo sinate or glufosinate residues. The Preferred Alternative is unlikely to be different in this regard (see, e.g., ( De Schrijver et al., 2007 ) )

. As noted in Subsection 1.3

– Coordin ated Framework Review and Regulatory Review, Pioneer has made a voluntary submittal to the US

- FDA for this product. Th e US

- FDA completed its review on March 25, 2013

. USDA

- APHIS ’ assessment of the potential impacts of the consumption of the Cry1F, Cry34Ab1 , Cry35Ab1, and PAT proteins by animals through animal feed considers the source of the gene and the expressed protein, exposure to pesticide residuals, and safety evaluations conducted by Pioneer. Our analysis is similar to that presented above in Subsect ion 4.5

– Public Health

. As described in Subsection 4.5

– Public Health , Pioneer has evaluated the allergenicity and toxicity of Pioneer 4114 Maize, and has compared this variety with a conventional corn isoline to assess composition. Compositional elemen ts compared included protein, fat, acid detergent fiber, neutral detergent fiber, carbohydrates, ash, fatty acids, amino acids, vitamins and minerals, key anti

- nutrients, and key secondary metabolites ( Pioneer, 2011b ) . In these studies, compositional comparisons were made between Pioneer 4114 Maize and a near isoline control grain ( Pioneer, 2011 b ) . There were no biologically meaningful differences for any of these compositional characteristics between the Pioneer 4114 Maize and conventional corn varieties , including 1507, 59122, and 1507 x 59122 Maize ( Pioneer, 2011b )

. Animals are already exposed to glufosinate and glufosinate residues in animal feed, particularly animal feed derived from 1507, 59122, and 1507 x 59122 Maize, as described in the No Action Alternative. Pioneer is not propos ing a change in label application rates for Pioneer 4114 Maize ; glufosinate will be applied in the same rates as those discussed in the No Action Alternative . Accordingly, the tolerance exempt ions for glufosinate for animal feed uses will not change, and are no different than those under the No Action Alternative. Based on the analysis of field and laboratory data and scientific literature provided by Pioneer ( Pioneer, 2011b ; Pioneer, 2012 ) , safety data available on other GE corn (e.g., 1507 , 59122 and
108DRAFT PIONEER 4114 MAIZE

1507 x 59122 Maize ) , and the already

- extant exposure of animals to Cry1F, Cry34Ab1, Cry35Ab 1, and PAT proteins through animal feed, USDA

- APHIS has concluded that a determination of nonregulated status of Pioneer 4114 Maize is unlikely to have an adverse impact on animal health with regard to animal feed. Overall impacts are similar to those of t he No Action Alternative.
4.7 SOCIOECONOMIC

4.7.1 Domestic Economic Environment Domestic economic impacts associated with adoption of a new GE trait are focused on the impact of that trait on the agronomic inputs and associated on

- farm costs, as well as the poten tial market impacts.
As noted in Subsection 2.2

– Agricultural Production of Corn, insect

- resistant corn and herbicide

- resistant varieties incorporating insect resistance are already widely cultivated in the United States. Additionally, a s discussed in Sub section 2. 7 .1

– Domestic Economic Environment , the cultivation of insect

- resistant Bt corn provides several collateral economic benefits. The incorporation of Bt proteins in corn has resulted in a decrease in the application of insecticides for the control of lepidopteran and coleopteran pests. Growers adopting this technology would benefit from the reduction in costs associated with the purchase, handling, applic ation and disposal of these insecticides. An additional economic benefit is the reduction in mycotoxin contamination that is a secondary impact from insect injury to corn kernels ( Munkvold and Hellmich, 1999 ; Munkvold and Hellmich, 2000 )

. Bt corn is less prone to insect injury, which, in turn, prevents the growth of fungi that produce mycotoxins ( Munkvold and Hellmich, 1999 ; Munkvold and Hellmich, 2000 ; Vincelli and Parker, 2002 ; US

- EPA, 2010b ; US

- EPA, 2010a ) . Reductions in fumonisin mycotoxins have a positive economic benefit to the growers as corn grain that contains mycotoxins above a ce rtain level is more likely to be rejected in the market, forcing growers to accept the lower price for non

- food uses ( US

- EPA, 2010b )

. 4.7.1.1 No Action: Domestic Economic Environment Under the No Action Alternative, Pioneer 4114 Maize w ill continue to be a regulated article under the regulations at 7 CFR Part 340. Growers and other parties who are involved in production, handling, processing, or consumption of corn will not have access to Pioneer 4114 Maize, but will continue to have access to currently

- available conventional and GE corn varieties (Hyten, personal communication, 2013 )

. As noted in Subsection 4.1

- Scope of the Environmental Analysis, this includes GE corn varieties that are no longer subject to the regulations are 7 CFR Part 340 and the plant pest provisions of the Plant Protection Act of 2000, such as 1507, 59122, and 1507 x 59122 Maize

. Growers currently select corn varieties based on a wide range of considerations, including market conditions and end use requirements. For example, as discussed in Subsection 2.7.1

– Domestic Economic Environment , the current market for ethanol has influenced some growers to
109DRAFT PIONEER 4114 MAIZE

convert soybean or cotton acreage to corn, as well as convert from livestock feed corn varieties to corn varieties prov iding better ethanol production feedstock ( USDA

- E RS, 2012e ; USDA

OCE, 2012b ) . The result of these corn cultivation trends includes changes in crop acreage dedicated to corn, shifts of corn varieties cultivated , and current commodity grain pricing

. These trends are unaffected by the No Action Alternative

. Growers adopting GE corn varieties incur a cost premium to acquire the seed ( NRC, 2010 )

. These technology fees are imposed by the product developer to cover their research and development costs, resulting in GE seeds that are traditionally more expensive than conventional seed ( NRC, 2010 ) . Growers cultivating GE crops all pay such t echnology fees. The NRC suggests that the benefits associated with the adoption of GE crops, including a reduction in agronomic inputs and increases in yield outweigh the extra costs of the GE seed ( NRC, 2010 )

. The continued emergence of glypho sate

- resistant weed biotypes has been identified as an economic concern ( NRC, 2010 ) . Glyphosate

- resistant weed biotypes have been demonstrated to reduce the effectiveness and economic benefits of glyphosate

- resistant crop systems ( Owen et al., 2011a ; Weirich et al., 2011 ) . Current research advocates using herbicides presenting multiple modes of action to manage these weeds ( see, e.g., Owen et al., 2011a )

. Growers would select other herbicides based on the targeted weed and herbicide resistance traits of the targeted weed ( Purdue, 2012 )

. Glufosinate is one such herbicide offering another mode of action to control glyphosate

- resistant wee ds. As previously noted in Subsection 2.2

– Agricultural Production in Corn , in 2010, 16% of the commercial corn acreage was cultivated in 1507, 59122, or the 1507 x 59122 hybrid, each of which is resistant to glufosinate ( Pioneer, 2012 )

. To manage herbicide

- resistant weeds, growers have increased herbicide application rates, increased the number of herbicide applications, and have returned to more traditional tillage pract ices ( Sandell et al., 2009 ; NRC, 2010 ) . The economic impacts of glyphosate

- resistant weeds are a direct result of increa sed inputs: additional herbicides are required to control the weeds; fuel costs increase as heavy equipment is used more frequently in the field for chemical application; and tillage and labor and management hours increase in association with the applicati on of additional herbicides and machinery use ( NRC, 2010 ; Weirich et al., 2011 ) . There is an additional cost from the reduction in yield associated with the competition of the crop with the weeds ( NRC, 2010 ; Weirich et al., 2011 ; Wilson, 2011 )

. Under the No Action Alternative, growers will continue to benefit from the adoption and cultivation of GE crops, including the commensurate reduction in costs associated with insecticide applications ( Duke and Powles, 2009b )

. At the same time, those growers managing herbicide

- resistant weeds may incur increased costs to employ a wide range of management techniques, including increased pesticide use and increased tillage. These trends are unaffected by the No Action Alternative

. 4.7.1.2 Preferred Alternative: Domestic Economic Environment Under the Preferred Alternative, trends related to the domestic economic environment are unlikely to be different than what is currently occurring in the No Action Alternative (Subsection 4.7.1.1).
110DRAFT PIONEER 4114 MAIZE

Pione er presented results of field trials comparing the performance and composition of Pioneer 4114 Maize with other GE and non

- GE corn varieties when cultivated under different agronomic conditions and using a range of agronomic inputs ( Pioneer, 2012 ; USDA

- APHIS, 2012e ) . No biologically meaningful differences were observed regarding agronomic characteristics between Pioneer 4114 Maize and any of the other varieties ( Pioneer, 2012 )

. As noted in Subsection 4.1

– Scope of the Environmental Analysis, Pioneer 4114 Maize is phenotypically identical to 1507 x 59122 Maize , meaning that it contains identical genetic elements (Cry1F, Cry34Ab1, Cry35Ab1, and PAT), identical traits, and similar agronomic performance . Based on th e identical phenotypes and the likelihood that Pioneer 4114 Maize will replace some of the acreage planted to 1507 x 59122 Maize, a determination of nonregulated status of Pioneer 4114 Maize is not anticipated to change the area or acreage of U.S. corn production (Subsection 4.2.1) or Agronomic Practices ( Subsection 4.2.2) associated with corn production , Additionally, a s noted in Subsection 2.7.1

– Domestic Economic Environment and Subsection 4.7.1.1

– No Action , the selection and cultivation of corn varieties, and the decision to cultivate corn (rather than soybeans or cotton, for example), is based on the market for the crop, and not the specific availability of a particular GE var iety. Based on th ese data, the potential domestic economic impacts associated with the cultivation of Pioneer 4114 Maize are no different than those currently observed for other corn varieties under the No Action Alternative.
4.7.2 Trade Economic Environment Potential impacts to the trade economic environment from a determination of nonregulated status of a new GE trait relates to the potential of that trait to impact trade of corn commodities between the United States and other countries

. 4.7.2.1 No Action: Trade Eco nomic Environment The cropping and marketing decisions made by corn growers are unlikely to be influenced by the selection of this alternative. The acreage planted in GE corn has increased over time, and it is expected that the corn produced will continue to be planted with the currently available GE corn. In 2012, 88% of the corn cultivated in the United States was GE ( USDA

- NASS, 2012b ) . U.S. corn will continue to play a r ole in global corn market, based on existing trends of corn production. The United States is the largest exporter of corn in the world market, although the anticipated export in 2012 will be reduced substantially as a result of the extreme heat and dryness in the Corn Belt ( USDA

- OCE, 2012d ; USDA

- OCE, 2012c )

. In 2010/20 11, the United States exported approximately 46.59 million metric tons of corn, against a global export market of 91.46 million metric tons ( USDA

- OCE, 2012c ) . Projections for the export market in 2011/2012 show an estimated United States export of 39. 19 million metric tons, against a global export market of 10 8

. 11 million metric tons ( USDA

- OCE, 2012c ) . How and where the corn and corn products will be used will be subject t o global market conditions. In 2012, over 25 countries were identified to import corn ( USDA

- FAS, 2012 ) . These conditions are not expected to change under the No Action Alternative.

111DRAFT PIONEER 4114 MAIZE

4.7.2.2 Preferred Alternative: Trade Economic Environment A determination of nonregulated status of Pioneer 4114 Maiz e is not expected to adversely impact the trade economic environment. Products containing 4114 Maize will have the same global uses as products containing 1507 x 59122 Maize , once appropriate regulatory authorizations are obtained in key export countries f or the Pioneer 4114 Maize ( Pioneer, 2012 )

. Pioneer plans to submit applications to several international agencies, including the regulatory authorities in Canada, China, J apan, Mexico, South Korea and Taiwan ( Pioneer, 2011b ) . These regulatory authorities include United States trade partners for import clearance and production approval ( USDA

- FAS, 2012 ) . As of the time of the preparation of this EA, conclusions of the other international agencies had not been published. However, Pioneer will only initiate a commercial launch of the product after obtaining all necessary authorizations in both the United States and key import countries with functioning regulatory processes ( Pioneer, 2011b )

. Based on these factors, the trade economic impacts associated with the determination of nonregulated sta tus of Pioneer 4114 Maize are anticipated to be similar to the No Action Alternative.

112DRAFT PIONEER 4114 MAIZE



### 5 CUMULATIVE IMPACTS
5.1 ASSUMPTIONS USED FOR THE CUMULATIVE IMPACTS ANALYSIS Potential cumulative impacts regarding specific issues are analyzed and addressed within this
s ection. The principal issue associated with the analysis of cumulative impacts pertains to Pioneer’s intention to limit the cultivation of Pioneer 4114 Maize as a foundation stock for developing stacked hybrids 28 through conventional breeding techniques ( Pioneer, 2011b )

. In this hybridization process, the traits in Pioneer 4114 Maize would be combined with the traits from other corn crop varieties that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000. USDA

- APHIS does not have jurisdiction under the Plant Protection Act of 2000 and Part 340 to review such stacked hybrids developed using nonr egulated articles and conventional hybridization techniques where there is no evidence of a plant pest risk. Accordingly, the body of this EA focuses on the cultivation of Pioneer 4114 Maize. This cumulative impacts analysis focuses on the incremental impa cts of the Preferred Alternative taken in consideration with related activities, including past, present, and reasonably foreseeable future actions, with a focus on the implications of future stacking or pyramiding of this product with glyphosate resistanc e

. USDA

- APHIS ’ rationale for limiting this review to a stacked product resulting in a hybrid combining the traits of Pioneer 4114 Maize with glyphosate resistance is provided below. It is important to reiterate that the four introduced proteins in Pioneer 4114 Maize, Cry1F, Cry34Ab1, Cry35Ab1, and PAT, are unique only insofar as they are integrated at a single locus 29 in the genome. The individual elements of Pioneer 4114 Maize have been commercially available for over a decade as 1507 and 59122 Maize, and m ore recently, hybrid stacks in which the two are combined as 1507 x 59122 Maize . Stacked products based off of the Pioneer 4114 Maize are not necessarily complete replacement products for 1507, 59122 or 1507 x 59122 hybrid varieties; some growers may only have a need for the 1507 product, for example, to control European Corn Borer ( Pioneer, 2011b ; Pioneer, 2012 )

. In 2010, commercial products
co ntaining the 1507 x 59122 Maize were grown on approximately 14 million acres, or 16% of U.S. maize acres ( GfK Kynetec, 2010 ; Pioneer, 2011b ) . Table 4

- 1 presents those US

- EPA registrations for commercial corn products containing 1507, 59122, or 1507 x 59122 Maize events.

28 As previously defined in Subsection 1.2, stacked products contain two or more genes targeting multiple pests; whereas pyramided products contain two or more genes targeting a single s pecies.

29 As previously defined in Subsection 1.2, an insertion at a single locus in the genome means that all introduced genetic elements are integrated at a single point. This is in contrast to conventional breeding stacks where the introduced genetic el ements are located in more than one point in the genome. For example, in 1507 x 59122 Maize, the gene encoding Cry1F is located in one location in the genome; whereas the gene encoding Cry34Ab1/Cry35Ab1 is located in another location in the genome
113DRAFT PIONEER 4114 MAIZE

To narr ow the issue, and provide a basis for a meaningful evaluation, this cumulative impact analysis is undertaken with the assumption that Pioneer 4114 Maize will be stacked with a GE corn variety exhibiting glyphosate resistance . This stack was selected for an alysis in this Cumulative Impacts section because Pioneer has expressly stated that a conventionally produced hybrid stacking Pioneer 4114 Maize with a glyphosate

- resistant corn variety is reasonably expected and highly likely to be the first product devel oped using the Pioneer 4114 Maize as the foundation variety ( Pioneer, 2011b ; Pioneer, 2012 ) . Note that the current environmental conditions and associa ted impacts associated with the cultivation of 1507, 59122, 1507 x 59122 hybrid varieties and Pioneer 4114 Maize have been presented previously in Subsections 2.1

- 2.3 and 4.1

- 4.3. Pioneer 4114 Maize includes three different Cry protein s , Cry1F and Cry34Ab1/Cry35Ab1 that provid e robust insect resistance to both coleopteran and lepidopteran insect pests

. Additional i nsect

- resistant traits could be added to 4114 stacks, including Bt 11, MON810 , MON88017 , MON89034 , MIR162, MIR604 , and 5307 , all of whic h are no longer regulated

. The genes and target pests for these Bt events are shown in Table 5

- 1 , below

.

Table 5

- 1
. Bt insect resistant traits currently on the U.S. market.
Bt Event Gene Controls

Bt 11 Cry1Ab European corn borer ( Ostrinia nubilalis )
MON810 Cry1A(b) European corn borer ( Ostrinia nubilalis )
MON88017 Cry3Bb1 Corn rootworm species ( Diabrotica species)
MON89034 Cry1A.105, Cry2Ab2 European corn borer ( Ostrinia nubilalis ), Asian corn borer ( Ostrinia furnacalis ), southwestern corn borer ( Diatraea grandiosella ), sugarcane borer ( Diatraea saccharalis, fall armyworm ( Spodoptera frugiperda ), corn earworm ( Helicoverpa zea ) Corn rootworm species ( Diabrotica species)

114DRAFT PIONEER 4114 MAIZE

MIR162 Vip3Aa20 Black cutworm ( Agrotis ipsilon ), corn earworm ( Helicoverpa zea ), fall armyworm ( Spodoptera frugiperda ), western bean cutworm ( Striacosta albicosta )
MIR604 mCry3A Corn rootworm species ( Diabrotica species)
5307 eCry3.1Ab Corn rootworm species ( Diabrotica species)
Sources: USDA

- APHIS

T he hybrid stack considered in th is cu mulative impacts analysis considers the combination of the glufosinate resistance and insect resistance from Pioneer 4114 Maize combined, using conventional breeding techniques, with glyphosate resistance from a GE corn variety no longer subject to the regulatory requirements at 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 . Corn varieties presenting resistance to both glufosinate and glyphosate are already in th e market (see, e.g., Darby, 2007 ; Neilsen, 2010 ; Wilson et al., 2010 )

. Recent commercial hybrids presenting this stack include the following products:

• DAS/Pioneer Hi

- Bred Herculex 1 Monsanto Roundup Ready ® Corn, which combined 1507 with NK603;

• Syngenta Agrisure GT/CB/ LL, which combined SYGGA21 and Bt 11;

• DAS Pioneer Hi

- Bred Herculex RW Monsanto Roundup Ready ® Corn 2, which combined 59122 and NK603;

• DAS Pioneer Hi

- Bred Herculex Xtra Monsanto Roundup Ready ® Corn 2, which combined 1507 x 59122 and NK603; and

• Monsanto Gen uity ® SmartStax ® , which combined Mon88017 x Mon89034 x 1507 x 59122 ( Neilsen, 2010 )

. Glyphosate is not an approved tank mix partner with glufosinate ( see, e.g., Bayer, 2012 )

. When growers adopt a stacked hybrid and elect to use both herbicides, the herbicides are applied sequentially, in accordance with label instructions, as part of the grower’s weed management strategies ( see, e.g., Monsanto, 2009 )

. The potential impacts from the cultivation of glyphosate

- resistant crops, with a corresponding analysis of the implications of the use of glyphosate, have been thoroughly evalua ted in other USDA

- APHIS EAs and EISs (notably the recent EISs for glyphosate

- resistant Sugar Beet and glyphosate

- resistant alfalfa) prepared to support determination of nonregulated status decisions, beginning in 1993 with the introduction of the first gly phosate

- resistant crop product. (See: www.APHIS.USDA.gov/biotechnology/not_reg.htm .) Several of these evaluations included crops expressing resistance to multiple herbicides. Specific crop examples include: 115DRAFT PIONEER 4114 MAIZE

• Sugar Beet, 2011. Monsanto and KWS SAAT AG Glyphosate

- resistant Sugar Beet (Petition No. 03

- 3 23

- 01p).

• Soybean, 2011. Monsanto Improved Fatty Acid Profile Soybean (which includes glyphosate resistance ) (Petition No. 09

- 201

- 01p).

• Alfalfa, 2011. Monsanto Glyphosate

- resistant Alfalfa (Petition 04

- 110

- 01p).

• Corn, 2009. Pioneer Glyphosate and Imadazolinone

- resistant Corn (Petition 07

- 152

- 01p).

• Cotton, 2009. Bayer Crop Science Glyphosate

- resistant Cotton (Petition 06

- 332

- 01p).

• Soybean, 2008. Pioneer Glyphosate and Acetolactate Synthase

- resistant Soybean (Petition No. 06

- 271

- 01p).

• Soybean, 2007. Monsanto Glyphosate

- resistant Soybean (Petition 06

- 178

- 01p).

• Cotton, 2005. Monsanto Glyphosate

- resistant Cotton (Petition 04

- 086

- 01p).

• Rapeseed 2001. Monsanto Glyphosate

- resistant Rapeseed (Petition 01

- 324

- 01p).

• Corn, 2000. Monsanto Glyphosate

- resistant Corn (Petitions No. 97

- 099

- 01p and 00

- 011

- 01p).

• Rapeseed 1998. Monsanto Glyphosate

- resistant Rapeseed (Petition 98

- 216

- 01p).

• Sugar Beet, 1998. Nov artis Seeds and Monsanto Glyphosate

- resistant Sugar Beet (Petition No. 98

- 173

- 01p).

• Corn, 1997. Monsanto Glyphosate

- resistant Corn. (Petition No. 97

- 099

- 01p).

• Corn, 1996. Monsanto Glyphosate

- resistant and European Corn Borer

- resistant Corn. (Petition No. 96

- 317

- 01p).

• Cotton, 1995. Monsanto Glyphosate

- resistant Cotton (Petition 95

- 045

- 01p).

• Soybean, 1993. Monsanto Glyphosate

- resistant Soybean (petition 93

- 258

- 01p). Glyphosate

- resistant (e.g., Roundup Ready ® ) corn varieties no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 have been in the market since 1996 ( USDA

- APHIS, 2012b )

. T he majority of corn cultivated in the U.S. is herbicide

- resistant, most of which is glyphosate

- resistant ( Duke and Powles, 2009a ; USDA

- ERS, 2011b )

. As evidenced by the above list of glyphosate

- resistant crops, the application and use of glyphosate on Roundup Ready ® crops has been well

- described

. Glyphosate is already used in corn in both conventional and Roundup Ready ® varieties. Future combinations of 4114 with one or more of the deregulated insect

- resistant traits in Table 5

- 1 could b e developed and sold. An analysis of the cumulative impacts of such potential stacking configurations is considered in the individual sections below.
5.2 CUMULATIVE IMPACTS: AREAS AND ACREAGE OF CORN PRODUCTION
As discussed in Subsection 4.2.1

– Areas and Acreage of Corn Production , the traits that are the foundation for Pioneer 4114 Maize are already in widespread cultivation, and there are no characteristics of Pioneer 4114 Maize that would be expected to change the areas or range of corn cultivated. Neit her the No Action Alternative nor the Preferred Alternative are expected to directly cause an increase in agricultural acreage devoted to corn production or those corn acres devoted to GE corn cultivation. The availability of Pioneer 4114 Maize as a breedi ng stock to create hybrid stacks would not change cultivation areas for corn production in the United States

116DRAFT PIONEER 4114 MAIZE

and there are no anticipated changes to the availability of GE and non

- GE corn varieties on the market under either alternative. Stacking Pioneer 4114 Maize with glyphosate

- resistant maize is not expected to influence areas and acreage of crop production. Glyphosate

- resistant corn has been commercially available since 1996 (see htt p://www.aphis.usda.gov/biotechnology/not_reg.html ). Glyphosate would likely continue to be a major component of weed management in corn production because of its flexibility in application, its efficacy against a broad spectrum of weeds, and its relatively low cost ( Powles, 2008 ; Duke and Powles, 2009a ; Green and Owen, 2011 ; Owen et al., 2011b )

. The glyphosate

- resistant varieties are already widely cultivated, based on the percentage of co rn currently treated with glyphosate (noted in Subsection 2.2

– Agronomic Inputs as 66 % of the acreage, ~ 57 million pounds) ( USDA

- NASS, 2011b ; USDA

- NASS, 2011a )

. Any stack between Pioneer 4114 Maize and a GE glyphosate

- resistant corn variety would also not be expected to increase the area or range of corn cultivation in the United States. The individual GE corn parents of this stack would have been previously reviewed and found to not likely extend the area of range of U.S. corn cultivation ( USDA

- APHIS, 2012e ) , strongly suggesting that any offspring from Pioneer 4114 and glyphosate

- resistant corn would not extend area or range of corn cultivation in the United States. Additionally, a s noted above in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , multiple commercial varieties stacking glufosinate and glyphosate resistance are already in the market and are being commercially cultivated. Moreover, as discussed in Subsection 4.2

– Agricultural Production of Corn , the cultivation of a GE var iety is not the determinative factor in a grower’s selection of corn. Growers select corn over soybean or cotton, for example, on the basis of market demand ( USDA

- ERS, 2011e )

. Consequently, a stacked product offering resistance to glufosinate and glyphosate is not expected to change the acreage or the range of corn production. Because changes in the acreage and locations for corn production using Pioneer 4114 Maize as a breeding foundation stacked with glyphosate resistance are not expected, no cumulative impacts have been identified for areas and acreage of corn pro duction.
5.3 CUMULATIVE IMPACTS: AGRONOMIC PRACTICES: TILLAGE, CROP ROTATION, AND AGRONOMIC INPUTS
5.3.1 Tillage and Crop Rotation
As discussed in Subsection 4.2.2

– Agronomic Practices , a determination of nonregulated status of Pioneer 4114 Maize is not expected to result in changes in current corn agronomic practices, as Pioneer 4114 Maize contains identical genetic elements to and requires the same cultivation practices as currently

- c ultivated GE corn varieties, such as 1507 x 59122 Maize

. USDA

- APHIS has determined that there are no past, present, or reasonably foreseeable actions that would aggregate with impacts of the proposed action to affect changes in tillage or crop rotation. P ioneer’s studies demonstrate Pioneer 4114 Maize is essentially indistinguishable from other corn varieties used in terms of agronomic characteristics and cultivation practices , such as 1507 x 59122 Maize ( Pioneer, 2011b )

. As noted in the introduction to this section, the GE parents of a stacked 4114/glyphosate

- resistant hybrid were previously reviewed and determined
117DRAFT PIONEER 4114 MAIZE

to be similar in agronomic characteristics to conventional corn varieties. Thus, any hybrid stemming from those two GE parents can be reasonably expected to be similar to conventional corn, and thus, benefit from the benefits of crop rotation. Additionally, because crop rotation strategies may be undertaken depend ent on market conditions, any one hybrid stack is unlikely to affect these market conditions.
The current cultivation of glyphosate

- resistant and glufosinate

- resistant GE corn varieties suggests that growers have already adopted tillage and crop rotation p ractices that incorporate the two herbicides into the crop weed control program.
5.3.2 Agronomic Inputs
As discussed in Subsection 4.2 .2

– Agronomic Practices , the cultivation of Pioneer 4114 Maize is unlikely to change current agronomic inputs for corn, including fertilizers, fungicides, insecticides , and herbicides because it is phenotypically identical to 1507 x 59122 Maize, a currently

- available corn variety

. The cultivation of a stacked variety containing both insect

- resistant and herbicide

- resistan t traits is consistent with current crop cultivation practices. As note in the introduction to this section, both 4114 and any non regulated glyphosate

- resistant variety were previously reviewed and determined to be similar in agronomic characteristics and cultivation requirements as conventional corn. Because of these agronomic and cultivation similarities with conventional corn, any offspring produced from these two GE parents will also likely be similar to conventional corn in agronomics and cultivation r equirements. The stacking of beneficial traits represents an increasing proportion of commercially

- available corn varieties (see Table 2

- 1 in Subsection 2.2.2.3). Data presented by USDA

- NASS suggests that corn varieties containing stacked traits are increa sing in popularity, with approximately 52% of the total corn acreage in 2012 cultivated in stacked varieties ( USDA

- NASS, 2012b ) . As noted in Subsection 5.1

– Assumptions Us ed for the Cumulative Impacts Analysis , there are several commercially available corn varieties that contain a combination of insect

- resistant and glufosinate

- and glyphosate

- resistant traits

. The factors discussed in Subsection 2.2

– Agricultural Producti on of Corn that influence the grower’s selection of insect

- resistant varieties, and the consequent application or avoidance of various insecticides are not changed by the cultivation of a hybrid stack because t he current trend to reduce insecticide use in reliance on the incorporated Bt proteins is expected to continue (see, Brookes and Barfoot, 2010 ; Brookes et al., 2012 )

. This stacked variety would present another grower option for cultivating a Bt corn variety. The addition of glyphosate resistance to the Pioneer 4114 events is not expected to require a change in the refuge strategies for managing insect resistance associated with the expression of the Cry proteins. As discussed in Subsection 2. 4.1.2

– Invertebrates , refuge strategies are part of an insect resistance management strategy to delay the devel opment of insect resistance to the expressed Cry proteins. Growers planting a stacked hybrid incorporating glyphosate resistance with the Pioneer 4114 Maize would need to ensure that their refuge strategy incorporated the appropriate herbicide

- resistant co rn varieties. The Genuity ® SmartStax ® hybrid, listed in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis is an example of a
118DRAFT PIONEER 4114 MAIZE

conventional hybrid containing traits resistant to both herbicides and presenting a convenient refuge strategy ( see Monsanto, 2012 )

. There are no cumulative impacts associated with insecticide use or refuge strategies associated with the cultivation of this hybrid. Refuge strategies are presented again in the Animal Communities analysis below. With regard to potential changes in use of certain herbicides, as noted in Subsection 4.2.2

– Agronomic Practices , corn containing traits resistant to glufosinate was cultivated on approximately 16% of the total corn acreage in 2010 ( GfK Kynetec, 2010 ) , but in that same time period, glufosinate was applied to only 2% of the corn acreage ( USDA

- NASS, 2011a )

. The cultivation of a corn variety exhibiting resistance to both glufosin ate and glyphosate provides the grower with the option to apply herbicides with two different modes of action to control hard

- to

control weeds. As discussed in Subsections 2.2.2, Agronomic Inputs, and 2.4.2, Plant Communities, growers continually adapt wee d management strategies to manage hard

- to

- control weeds ( Norsworthy et al., 2012 ; Vencill et al., 2012 )

. Weed control methods differ depending on a number of factors including regional practices, grower resources, and crop trait; the techniques may be direct (e.g., mechanical, biological, and chemical) or indirect (e.g., cultural ) ( Hoeft et al., 2000 )

. Mechanical controls includ e a reversion to tillage , and chemical controls include the use of herbicides with alternative modes of action, such as auxin growth regulators, amino acid inhibit ors, chlorophyll pigment inhibitors, or lipid biosynthesis inhibitors ( Ross and Childs, 2011 ; Norsworthy et al., 2012 ; Vencill et al., 2012 )

. The practice of using herbicides with alternative modes of action could potentially diminish the populations of glyphosate

- resistant weeds and reduce the likelihood of the development of new herbicide

- resistant weed popula tions ( Dill et al., 2008 ; Duke and Powles, 2008 ; Owen, 2008 ; Duke and Powles, 2009b ; Pioneer, 2011b ; Norsworthy et al., 2012 ; Vencil l et al., 2012 )

. These alternative weed management strategies are already widely used, and growers cultivating hybrid varieties resistant to both glyphosate and glufosinate are already able to take advantage of this strategy. These strategies are unlikely to change after the development of a 4114/glyphosate

- resistant maize variety. The extent to which growers adopt this strategy will be contingent upon their response to the emergence of these weeds in their fields.
As discussed in Agronomic Practices ( Subsection s 2.2.2 an d 4.2.2 ) , the use of glufosinate on total corn acres has remained stable and low over the past decade (2

- 6% of total U.S. corn acres treated with glufosinate during 2001

- 2011) ( Pioneer, 2012 ) To the extent that growers recognize the value in cultivating a stacked hybrid allowing the use of herbicides with multiple modes of action, the cultivation of varieties stacking Pioneer 4114 Maize with glyphosate resistance may allow growers to substitute glufosinate or glyphosate or both for other herbicides such as atrazine and metolachlor, as well as avoid reverting to conventional tillage ( Vencill et al., 2012 ) . As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , there are several commercial varieties containing these same resistance traits already on the market and the development of a hybrid containing the traits of Pioneer 4114 Maize and glyphosate

- resistant are unlikely to change these current practices

. On Roundup Ready ® varieties, glyphosate is applied in many formulat ions post

- emergence, in application rates ranging from 0.56 to 1.12 lb ae/acre ( Loux et al., 2011 ) . Glyphosate also is commonly used in conjunc tion with many other herbicides as a tank mix for both pre

- plant/pre

- emergence and post

- emergent weed control up through the 12

- leaf stage or until the corn reaches a height of 30 inches ( see, e.g., Loux et al., 2011 ) . Hybrids combining resistance to both herbicides will provide growers with the 119DRAFT PIONEER 4114 MAIZE

opportunity to apply tank mixes of either glyphosate or glufo sinate with other herbicides for control of mixed weeds, and may be valuable in providing alternative controls to growers managing glyphosate

- resistant weeds ( Pioneer, 2012 ) . As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis, there are several other commercial hybrids currently cultivated that also are resistant to both glyphosate and glufosinate. The application of both herbicides to a corn crop is thus not a new event. As previously noted, long

- term trends related to herbicide use resulting from the use of GE technologies are the subject of intense debate ( Benbrook, 2009 ; Brookes and Barfoot, 2010 ; Benbrook, 2012 ; Brookes et al., 2012 )

. For example, Benbrook has recently published an analysis of the impacts of GE crops on pesticide use in the United States ( Benbrook, 2012 ) . In this publication, he estimates that herbicide

- resistant crop technology has led to a 239 million kg increase in herbic ide use in the United States between 1996 and 2011 and that Bt crops have reduced insecticide applications by 56 million kg over the same time period. Although Benbrook's conclusion regarding a reduction in insecticide related to the use of Bt crops is
con sistent with the findings of other analysts, his analysis of trends in herbicide use is based on assumptions that may lead to overestimates of herbicide use in herbicide

- resistant crop programs, including assumptions of herbicide usage on conventional crop s that may be underestimated, extrapolation of trends to years where no USDA data are available, and not accounting for the role of increased crop acreage in the estimated increases in herbicide use. ( Brookes et al., 2012 )

. Further, Benbrook’s analysis fail s to consider the differing environmental profiles of herbicides used, particularly the substitution of relatively environmentally benign products for those with less environmentally friendly profiles ( Brookes and Barfoot, 2012 )

. In contrast to Benbrook's findings, Brookes and Barfoot ( 2012 ) estimate that GM crop adoption in the United States reduced the use of pesticides in the United States by 246 million kg compared to what might reasonably be expected if GM crops were no longer available. Growers are already cultivating stacked hybrids presenting the same traits as a 4114/glyphosate resistant stack; to accomplish this, these growers have already adopted cultivation practices, including managing agronomic inputs for fertilizer, herbicides, pesticides and fungicides appropriate for these stacked hybrids. As discussed in this subsection, there are n o changes in practices expected to accommodate such new hybrids ; moreover, these new hybrids can be reasonably expected to replace cultivation of some of these existing hybrid varieties. Consequently, overall impacts to agronomic practices associated with the adoption of such stacked varieties are not expected, and no cumulative impacts have been identified for a gronomic prac tices associated with corn production.
5.4 CUMULATIVE IMPACTS: ORGANIC CORN FARMING AND SPECIALTY CORN SYSTEMS

5.4.1 Organic Corn Farming A determination of nonregulated status of Pioneer 4114 Maize is not expected to change the market demands for GE corn or corn p roduced using organic methods. A determination of nonregulated status of Pioneer 4114 Maize would add another GE corn variety to the conventional corn market. Based upon recent trend information, adding GE varieties to the 120DRAFT PIONEER 4114 MAIZE

market is not related to the abil ity of organic production systems to maintain their market share. Since 1994, 25 GE corn events or lines have been determined by USDA

- APHIS to be no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant P rotection Act of 2000. Between 2000 and 2008, the total acreage associated with the organic production of corn increased from 78,000 to approximately 19 5 ,000 acres, despite concurrent increases in conventional corn acreage ( USDA

- NASS, 2012a )

. As discussed in Subsection 2.2.3

– Organic Corn Farming and Specialty Corn c ertified organic corn acreage is a relatively small percentage of overall corn production in the U nited States

. The most recently available data show 169,000 acres of certified organic corn production in 20 11, which represent ed approximately 0.20% of the 9 2 million acres of corn planted in 201 1 ( USDA

- NASS, 2012a )

. The approximately 169,000 acres in 2011 represent a decrease from the approximately 195,000 certified organic corn acres cultivated in 2008 ( USDA

- NASS, 2012a )

. These acreage trends suggest that adding a new GE corn variety, in this case a new breeding stock stacked with glyphosate resistanc e , is not related to the ability of an organic production systems to maintain their market share. As Table 4

- 1 illustrates, corn varieties containing the same traits as Pioneer 4114 Maize have been in commercial cultivation for over a decade. Corn varietie s resistant to glyphosate and no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 have been on the United States market since 1996 ( see http://www.aphis.usda.gov/biotechnology/not_reg.html )

. The glyphosate

- resistant varieties are already widely cultivated, based on the percentage of corn currently treated with glyphosate (noted in Subsection 2.2

– Agronomic Inputs as 66 % of the acreage, ~ 57 million pounds) ( USDA

- NASS, 2011b ; USDA

- NASS, 2011a )

. Based on these trends, and the corresponding production systems already in place to maintain varietal integrity, USDA

- APHIS has determined that there are no cumulative impacts to organ ic corn production from a determination of nonregulated status for Pioneer 4114 Maize.
5.4.2 Specialty Corn Production A determination of nonregulated status of Pioneer 4114 Maize is not expected to change the market demands for GE corn or corn produced using s pecialty systems. A determination of nonregulated status of Pioneer 4114 Maize would add another GE corn variety to the corn market.
As discussed in Subsection 5. 4 .1

– Organic Corn Farming, corn varieties contain ing the same traits as Pioneer 4114 Maize h ave been in commercial cultivation for over a decade. Corn varieties resistant to glyphosate and no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 have been on the United Sta tes market since 1996, and currently occupy a substantial part of the market. As discussed in Organic Corn Farming and Specialty Corn Systems ( Subsections 2.2.3 and 4.2.3 ) , growers already consider corn identity protection as part of their management strategies, from planting through harvest. Based on Pioneer’s demonstration that there are no changes in agronomic characteristics and cultivation practices, and because the market share of specialty corn varieties is unlikely to
121DRAFT PIONEER 4114 MAIZE

change by the introductio n of Pioneer 4114 Maize and hybrids based on this variety, USDA

APHIS has determined that there are no past, present, or reasonably foreseeable changes that would impact specialty corn producers and consumers.
5.5 CUMULATIVE IMPACTS: SOIL QUALITY
USDA

- APHIS h as not identified any cumulative impacts from the use of Pioneer 4114 Maize and its hybrids to soil quality. Pioneer has compared phenotypic, agronomic, and cultivation characteristics between Pioneer 4114 Maize and control corn hybrids. Pioneer 4114 Maize requires the same soil, fertilizer, water, and pest management practices as conventional corn, including the currently

- available 1507 x 59122 Maize ( Pioneer, 2011b )

. Addit ionally, Pioneer 4114 Maize also contains identical introduced genetic elements as 1507, 59122, and 1507 x 59122 Maize. Consequently, the phenotypic, agronomic, and ecological data presented by Pioneer support the conclusion by USDA

- APHIS that Pioneer 4114 Maize would not result in any substantial modification in soil properties that are not already found in conventional corn production practices ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. As noted in Subsection 5.1

– Assumptions Us ed for the Cumulative Impacts Analysis , the application and use of glyphosate on Roundup Ready ® crops has been well

- described in the EAs and EISs noted, and will not be further addressed here. Glyphosate is already used in corn in both conventional and Rou ndup Ready ® varieties. The stacking of Pioneer 4114 Maize with a glyphosate

- resistant variety complements the glyphosate

- resistant crop by providing growers with the option to also apply glufosinate in those fields where glyphosate

- resistant and inherently hard

- to

- control weeds have emerged, allowing the grower to avoid reverting to tillage ( Towery and Werblow, 2010 ) . As discussed in Subsection 5.1 0

– Cumulative Impacts: Plant Communities , the use of herbicides with multiple modes of action must also take into consideration the emergence of weed varieties containing traits resistant to multiple herbicides. As glyphosate

- resistant weed varieties have emerged, growers have returned to increa sed tillage as one of the weed management practices. As discussed in Soil Quality ( Subsections 2.3. 1 and 4.3. 1 ) , the adoption of conservation tillage has resulted in substantial improvements to soil health ( Towery and Werblow, 2010 ) . The cultivation of a corn variety stacking multiple m odes of action, in this case, resistance to glufosinate ammonium, along with glyphosate

- resistance , provides growers with an opportunity to maintain their conservation tillage strategies. As noted in Soil Quality ( Subsections 2.3 .1 and 4.3 .1 ) , maintaining conservation tillage will have a positive impact on soil quality by minimizing soil erosion, increased retention of organic matter, and increased water retention, among other benefits ( Peet, 2001 ) The analysis of the impacts of glyphosate use on soil resources is well documented ( Duke et al., 2012 )

. Glyphosate is strongly adsorbed to soil, and once it enters the soil, it is essentially unavailable to plants because of this adsorption ( US

- EPA, 1993b ; Giesy et al., 2000 )

. Glyphosate has been shown to rapidly dissipate from most agricultural ecosystems across a wide range of soil and climatic conditions , from 1.7 to 141.9 days , with a median soil half

- life (the time it takes for half of the glyphosate to dissipate in the soil) of 14.9 days , depending on a wide range of soil chemical and physical parameters ( Giesy et al., 2000 )

. Impacts of glyphosate to soil microorganisms are discussed in Subsection 5.1 1

– Cumulative Impacts: Soil Microorganisms

.
122DRAFT PIONEER 4114 MAIZE

The potential future cultivation of a stacked variety and the associated use of glyphos ate in addition to glufosinate are not expected to result in cumulative impacts to soil as corn varieties already exhibiting resistance to glufosinate and glyphosate exist and are already cultivated in the United States

. Based on these findings, and becau se the amount of corn grown in the United States is unlikely to change by the introduction of Pioneer 4114 Maize, USDA

- APHIS has determined that there are no cumulative impacts to soil quality

. 5.6 CUMULATIVE IMPACTS: WATER RESOURCES No cumulative impacts on water use have been identified for a determination of nonregulated status of Pioneer 4114 Maize or its hybrids. A determination of nonregulated status of Pioneer 4114 Maize or its hybrids is not expected to change the water use and irrigation practices us ed in commercial corn production. As discussed above in Subsection 5.2

– Area s and Acreage of Corn Production , c orn acreage will not increase as a result of cultivation of a hybrid combining 4114 with a glyphosate

- resistant corn. Consequently, if corn acre age does not change as a result of this hybrid, then total water use trends by corn are unlikely to change. Moreover, as presented in Subsection 4.3.2, Water Resources, for Pioneer 4114 M aize, and previous reviews of GE glyphosate

- resistant corn , these var ieties require typical moisture levels as conventional corn. Any offspring from 4114 and glyphosate

- resistant corn will require similar moisture levels as its parents. Thus, any offspring from 4114 and glyphosate

- resistant corn is likely to require similar moisture levels as conventional corn

. Accordingly, no cumulative impact s to water use or irrigation in corn are anticipated. The potential stacking of Pioneer 4114 Maize with a glyphosate

- resistant variety provides growers with the option to apply herbici des with different modes of action, an approach proposed to mitigate the future development of herbicide

- resistant weeds ( Duke and Powles, 2009b ) . Glyphosate

- resistant crops, also identified as “Roundup Ready ® ” have been in commercial use since 1993 when glyphosate

- resistant cotton was introduced. Glyphosate

resistant corn was introduced in 1996 (see http://www.aphis.usda.gov/biotechnology/not_reg.html ).
As noted in Subsection 5.1

– Assumptions Used for the Cumula tive Impacts Analysis , the application and use of glyphosate on Roundup Ready ® crops has been well

- described and will not be further addressed here. Glyphosate is already used in corn in both conventional and Roundup Ready ® varieties.
As discussed in Subs ection 2.2.2.1

– Tillage , the adoption of conservation tillage has resulted in substantial improvements to soil health, and correspondingly, water quality, in those areas where the practice has been adopted ( USDA

- NRCS, 2006b ; Givens et al., 2009 ; Towery and Werblow, 2010 ; USDA

- NRCS, 2010 ) . The cultivation of a corn variety stacking multiple modes of action, in this case, resistance to glufosinate ammonium, along with glyphosate resistance , provides growers with an opportunity to preserve their conservation tillage strategies by com bining herbicides with multiple modes of action rather than reverting to tillage. As discussed in Physical
123DRAFT PIONEER 4114 MAIZE

Environment ( Subsections 2.3 and 4.3 ) , conservation tillage improves soil water retention and reduces soil erosion and nutrient runoff from the field s, each aspect of which benefits water quality ( Peet, 2001 )

. Maintaining conservation tillage will have a posit ive impact on water quality and a stacked corn product exhibiting Pioneer 4114 and glyphosate resistance may provide growers an opportunity to maintain conservation tillage practices that have already been adopted

. The potential impacts of glyphosate use on water resources are well

- documented in the previous EAs and EIS cited in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis

. Although glyphosate is very soluble in water, it is strongly adsorbed to soils; consequently, glyphosate is u nlikely to leach into groundwater or surface water runoff following application ( US

- EPA, 1993b ; Giesy et al., 2000 ) . Relying on toxicological data, bioaccumulation and biodegradation studies, and acute and chronic tests on fish and other aquat ic organisms, US

- EPA has determined that “the potential for environmental effects of glyphosate in surface water is minimal”, and has further noted a half

- life in water of 8.1 days in an anaerobic aquatic environment and 7 days in an aerobic aquatic enviro nment ( US

- EPA, 1993b )

. The potential future cultivation of a stacked variety and the associated use of glyphosate in addition to glufosinate are not expected to result in cumulative impacts to wat er resources. The total amount of herbicide applied to hybrids based on the Pioneer 4114 Maize would be limited by application and per year rates approved by the US

- EPA in the pesticide labels. As discussed in Subsection 1.3

– Coordinated Framework Review and Regulatory Review , the US

- EPA ’s pesticide registration process under FIFRA requires that US

- EPA determine, through testing, that the pesticide will not cause unreasonable adverse effects on humans, the environment and non

target species when used in ac cordance with the label. US

- EPA ’s label restrictions include a prohibition against applying glyphosate to water or to areas where surface water is present, or to intertidal areas below the mean high water mark ( see, e.g., Prokoz, 2010 )

. In 2010, fertilizer (primarily nitrogen) was applied to the majority of corn acres, and herbicides applied to 98% of planted corn ( USDA

- NASS, 2011c ) . Of the treated acres, glyphosate was the most commonly applied herbicide active ingredient that year ( USDA

- NASS, 2011c )

. When used consistent with registered uses and EPA

- approved labels, glyphosate present s minimal risk to surface and groundwater . Irrigation from surface and subsurface sources can reduce water quantity and impact water quality by the used water acquiring increased sediment, nutrients, and chemicals adsorbed to soil that is subsequently lea ched to groundwater, or returned to surface water. Recent estimates indicate only 11.0 to 11.5% of corn acreage is irrigated in the U.S. ( NCGA, 2011 )

. Based on these findings, and because the amount of corn grown in the United States is unlikely to change by the introduction of Pioneer 4114 Maize, USDA

- APHIS has determined that there are no cumulative impacts to water resources.
5.7 CUMULATIVE IMPACTS: AIR QUALITY
USDA

- APHIS has determined that there are no past, present, or reaso nably foreseeable actions that would aggregate with impacts of the proposed action that would have a negative impact on

124DRAFT PIONEER 4114 MAIZE

air quality. The consequences of the Preferred Action Alternative on commercial corn production and the resulting air quality are simila r to those expected for the No Action Alternative. The stacking of the Pioneer 4114 Maize with corn varieties containing resistance to the herbicide glyphosate is not expected to impact air quality. Glyphosate

- resistant crops, also identified as Roundup R eady ® have been determined by USDA

- APHIS to have nonregulated status since 1993 when glyphosate

- resistant cotton was introduced. Glyphosate

- resistant corn was introduced in 1996 (see http ://www.aphis.usda.gov/biotechnology/not_reg.html ). As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , the application and use of glyphosate on Roundup Ready ® crops has been well

- described in the EAs and EISs noted, and will not be further addressed here. Glyphosate is already used in corn in both conventional and Roundup Ready ® varieties. Some agricultural practices, including tillage and equipment use, can affect air quality through emissions from soil and equipment ( US

- EPA, 2012b ) . Cultivation of a stacked corn variety, containing resistance to glyphosate and glufosinate, would enable growers to use a combination of herbicides to control glyphosate

- resistant weeds instead of returning to tillage practices ( Owen et al., 2011a ) , reducing these impacts to air quality when compared with conventional tillage. As noted in Subsection 4.2

– Agricultural Production of Corn , any GE corn variety used as part of such a sta ck is likely to require the same cultivation requirements as conventional corn. Glyphosate has a low vapor pressure and volatility from soils ( U S

- EPA, 1993a ) . Glyphosate’s EPA

- approved label provides measures for minimizing the potential air quality impacts from its use. When used in accordance with registered uses and EPA

- approved labels, glyphosate poses minimal risks to air quality. Incre asing or decreasing the amount of corn production acreage and its associate d agronomic practices with emissions potentially impact air quality. Accordingly, there are no differences in agricultural practices between conventional and GE corn, whether a sin gle trait event or a stack variety, that would impact air quality. Based on these findings, and because the amount of corn grown in the United States is unlikely to change following a determination of nonregulated status of Pioneer 4114 Maize, USDA

APHIS h as determined that there are no cumulative impacts to air quality.
5.8 CUMULATIVE IMPACTS: CLIMATE CHANGE
USDA

- APHIS has not identified any cumulative impacts for this issue. USDA

- APHIS does not anticipate any changes in corn production practices or an expans ion of corn acreage as a result of Pioneer 4114 Maize being no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000. Some agricultural practices, including tillage and equipment u se, can contribute to climate change through releasing GHG emissions from soil and equipment ( US

- EPA, 2012b )

. Cultivation of a stacked corn variety, containing traits resistant to herbicides with different modes of action, in this case glyphosate and glufosinate, would enable growers to use a combination of herbicides to control glyphosate

- resistant weeds instead of returning to conventional tillage practices ( Towery and Werblow, 2010 ; Owen et al., 2011a )

. As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , corn products
125DRAFT PIONEER 4114 MAIZE

containi ng these stacked traits are already commercially cultivated. As discussed above in Agronomic P ractices (Subsections 2.2.2 and 4.2.2), S oil Quality (Subsections 2.3.1 and 4.3.1) , and C limate C hange (Subsections 2.3.4 and 4.3.4), the adoption of herbicide

- re sistant crops and conservation tillage (or the avoidance of conventional tillage) has been identified as providing climate change benefits by increasing carbon sequestration in soils. Based on these findings, and because the amount of corn grown in the Uni ted States is unlikely to change by the introduction of Pioneer 4114 Maize, USDA

- APHIS has determined that there are no cumulative impacts to climate change. The use of Pioneer 4114 Maize as a foundation stock for production of hybrid varieties containing multiple stacked traits, including glyphosate resistance , is not expected to cause any cumulative effect on climate change.
5.9 CUMULATIVE IMPACTS: ANIMAL COMMUNITIES
USDA

- APHIS has determined that there are no impacts from past, present, or reasonably fores eeable actions that would aggregate with effects of the proposed action to create cumulative impacts or reduce the long

- term productivity or sustainability of any of the resources associated with the ecosystem in which Pioneer 4114 Maize is planted.
5.9.1 Mamma ls and Birds
As discussed in Subsection 4.4

– Biological Resources , cultivation of Pioneer 4114 Maize, with the attendant accumulation of the Cry and PAT proteins providing insect resistance and herbicide resistance , is unlikely to have direct toxic effects on non

- target organisms exposed to the Bt and pat genes and the corresponding Cry and PAT proteins ( USDA

- APHIS, 2012e ) . Therefore, the likelihood of adverse cumulative impacts on non

- target organisms and bi odiversity as a consequence of direct exposure to these proteins following the introduction of Pioneer 4114 Maize is minimal. Glyphosate commonly is used in conjunction with many other herbicides as a tank mix for both pre
- plant/pre

- emergence weed control up through the 12

- leaf stage or until the corn reaches a height of 30 inches ( see, e.g., Loux et al., 20 11 ) . As noted above, glyphosate is not currently approved as a tank mix with glufosinate ( see, Bayer, 2012 )

. USDA

- APHIS expects that any applications of glyphosate with glufosinate would be consistent with the currently approved rates. USDA

- APHIS expects that both herbicides would be use d in accordance with proposed labels. Stacked and pyramided crop varieties, exhibiting resistance to multiple herbicides and different forms of insect resistance, are widespread in the industry. As noted in Subsection 5.1

– Assumptions Used for the Cumula tive Impacts Analysis , stacked varieties exhibiting resistance to both glufosinate and glyphosate are already commercially cultivated. The introduction of hybrids based on Pioneer 4114 Maize have the potential to impact the rate of development of such varieties, as the availability of a foundation stock with the key genes on a single loci facilitates the inclusion of these gene traits in the development of other hybrid varieties ( Pioneer, 2011b ) . Although the rate of development of such hybrids may be affected by the availability of Pioneer 4114 Maize, hybr ids based on the 1507 x 59122 variety are already in commercial
126DRAFT PIONEER 4114 MAIZE

cultivation. In that regard, potential cumulative impacts from the cultivation of hybrids based on Pioneer 4114 Maize are the same as those already occurring under the No Action Alternative. A ccordingly, USDA

- APHIS expects that the associated cumulative impacts to animals of the availability of Pioneer 4114 Maize are negligible. Glyphosate is already widely used in corn ( USDA

- NASS, 2011a ; USDA

- NASS, 2011b )

. As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , there are already several stacked varieties commercially available that contain traits resistant to both glufosinate and glyphosate. Glyphosate and glufosinate are already applied to corn varieties in accordance with the label restrictions; neither herbici de requires a label change to be used on a stacked hybrid variety. A hybrid based on Pioneer 4114 Maize also contain ing traits resistant to glyphosate would provide growers with another corn varietal option allowing the use of herbicides with multiple mode s of action consistent with current practice

. With regard to potential risk to mammals and birds from glyphosate expose, the EPA has conducted an ecological risk assessment for glyphosate and determined that there are minimal effects to birds and mammals ( as well as fish and invertebrates) ( see, e.g.,US

- EPA, 1993b ) There is no evidence that animal exposure to these herbicides would change from the current condition in the event of the cultivation of such a hybrid stack. Growers generally have three options available to manage glyphosate

- resistant weeds: 1) increase the frequency and magnitude of glyphosate applications within the restrictions of the US

- EPA labels; 2) use other herbicides in addition to glyphosate; or 3) increase the use of tillage and other mechanical controls ( USD A

- NRCS, 2010 ; Owen et al., 2011a ) . A hybrid incorporating glufosinate resistance and glyphosate resistance would achieve this goal. By combining herbicides offering alternative modes of action into their agronomic practices, the farmer can reduce the use of other herbicides which have been deployed to manage glyphosate

- resistant weeds and continue to adopt conservation tillage systems. The associated adoption of
conse rvation tillage and the reduced use of soil

- applied herbicides have the potential to benefit animal communities in fields planted with Pioneer 4114 Maize ( Eggert et al., 2004 ) . The reduction in herbicide use and increase in conservation tillage both provide improved habitat for animals in and around the cornfields.
5.9.2 Invertebrates
As discussed in Subsection 5.3.2

– Agronomic Inputs , the addition of a glyphosate resistance to the Pioneer 4114 events is not expected to require a change in the refuge strategies for managing insect resistance associated with the expression of the Cry proteins. As discussed in Subsection 2. 4.1.2

– Invertebrates , refuge strategies are part of an insect resistance management strategy to delay the development of insect resistance to the expressed Cry proteins. Growers planting a stacked hybrid incorporating glyphosate resistance with the Pioneer 4114 Maize would need to ensure that their refuge strategy incorporated the appropriate herbicide

- resistant corn varieties. The Genuity ® SmartStax ® hybrid, listed in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis and already on the market, is an example of a conventional hybrid contain ing traits resistant to both herbicides and presenting a convenient refuge strategy ( see Monsanto, 2012 )

. Invertebrate exposure to glyphosate has been addressed in the EAs and EISs noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts A nalysis

. Glyphosate 127DRAFT PIONEER 4114 MAIZE

does not present an unreasonable risk to non

- target invertebrates when used in accordance with the label use restrictions ( see, e.g., US

- E PA, 1993b )

. Similarly, insect

- resistant Bt corn does not adversely affect non

- target arthropods (e.g., ( Balog et al., 2011 ) ( Devos et al., 2012 ) ; ( Rauschen et al., 2009 ) ; ( Raybould and Vlachos, 2011 ) ( Naranjo et al., 2005 )

. Based on these findings, USDA

- APHIS has determined that there are no past, present, or reasonably foreseeable acti ons that would aggregate with effects of the proposed action to affect animals associated with the determination of nonregulated status of Pioneer 4114 Maize

. 5.10 CUMULATIVE IMPACTS: PLANT COMMUNITIES
5.10.1 Surrounding Landscapes and Other Vegetation in Cornfields

T he potential impacts associated with exposure of plant communities to glyphosate has been addressed in previous USDA

- APHIS analyses (see, http://www.aphis.usda.gov/biotechnology/not_reg.h tml ). As discussed in Subsection 4.4.2

– Plant Communities , the cultivation of Pioneer 4114 Maize does not require different management strategies than commercially available corn varieties, including commercial varieties based on 1507 x 59122 Maize

. Spray drift is a concern for non

- target susceptible plants growing proximate to fields. Similar to glufosinate, US

- EPA label restrictions are already in place for glyphosate to address the potential off

- site drift of glyphosate and minimize this impact (see, e.g., Prokoz, 2010 ; Bayer, 2012 )

. As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , growers are already cultivating commercial hybrids containing traits resistant to both glufosinate and glyphosate. There is no evidence that the herbicide label restrictions or application requirements for either glufosinate or glyphosate would be any different than those currently used in the cultivation of the aforementioned conventional hybrid stacks that are already cultivated.
As di scussed in the EAs and EISs referenced in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , glyphosate is a non

- selective foliar herbicide, with little or no herbicidal activity in soil ( Duke et al., 2012 )

. Some literature suggests that glyphosate adversely affects mineral nutrition in glyphosate

- resistant crops, leading to increased plant disease, and that glyphosate

- resistant crops are more susceptible to plant diseases due to other mechanisms (see, e.g., Kremer and Means, 2009 ; Duke et al., 2012 )

. The latest literature on this concern questions the science and the significance of the reported impacts associated with the use of glyphosate, specifically noting that yield data for crops that are predominately glyphosate

- re sistant varieties does not support the contention that there are substantial mineral uptake or disease problems associated with the use of this herbicide ( Duke et al., 2012 )

. As noted on Tab les 2

- 3 and 2

- 4, Italian Ryegrass, L. multiflorum , identified in Oregon 2010 is the only weed identified as resistant to both glufosinate and glyphosate ( Heap, 2012 ) . The International Survey of Herbicide Resistant Weeds (ISHRW) identifies many weeds containing traits for herbicide

- res istance to multiple modes of action. Growers implementing weed control strategies incorporating herbicides expressing multiple modes of action will need to adhere closely to the Stewardship Strategy to avoid selecting for such species. For example, Barnyar d
128DRAFT PIONEER 4114 MAIZE

grass ( Echinochloa crus

- galli ) is identified as resistant to synthetic auxins in the United States; whereas in Brazil, this same species also is identified as resistant to the ALS herbicides ( Heap, 2012 ) . Kochia ( K. scoparia ) has been identified as resistant to both synthetic auxins and glyphosate in the United States ( Heap, 2012 ) . This weed, despite being identified as herbicide

resistant in 1994, is not reported to be a major crop management problem ( Wright et al., 2011 )

. As noted in Subsec tion 2.4.2

– Plant Communities , the preferred method to manage hard to control weeds involves, among other strategies, use of herbicides with multiple modes of action. As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , stack ed hybrid varieties presenting the grower with options to consider herbicides with multiple modes of action, including resistance to both glyphosate with glufosinate, are already commercially available. Growers are already using both glyphosate and glufosi nate to control weeds in similar stacked corn hybrids ( se e, e.g., Monsanto, 2012 ) . The hybrid stack envisioned here would present growers with another management option for addressing these hard to control weeds similar to those varieties already on the market. Based on these findings, USDA

- APHIS has not ide ntified any cumulative impacts to surrounding landscapes or weed control associated with potential stacking with a glyphosate resistance event.
5.10.2 Corn as a Weed or Volunteer Pioneer has committed to preparing a Stewardship Strategy to preserve the effectiveness of the products associated with cultivation of future hybrids ( Pioneer, 2012 ) . Grow ers cultivating Pioneer 4114 Maize varieties would be expected to accept this stewardship plan as part of the technology agreement to purchase and cultivate the products ( see also Pioneer, 2011c ; Pioneer, 2011a ; Pioneer, 2012 ) . As discussed in Agronomic Practices ( Subsections 2.2.2 and 4.2.2 ) , an essential aspect of these stewardship strategies is growers’ adherence to US

- EPA ’s approved label application rates, and the use o f herbicides expressing multiple modes of action ( Owen et al., 2011a )

. USDA

- APHIS assumes that growers will use these herbicides in accordance with US

- EPA ’s label restrictions, and that these label requirements are intended to minimize potential
non
- target impacts. The remainder of this analysis of potential cumulative impacts to plant communities focuses on the control of volunteer corn engineered to contain herbicide

- resistant traits for herbicides with multiple modes of action. As stacked crops are developed contain ing multiple herbicide resistance traits, the options for volunteer control become more limited. Volunteer corn from a parent strain that exhibits glyphosate resistance might be controlled in a LibertyLink ® crop with the use of glufosinate ( Minnesota, 2009 ; Reddy, 2011 ) . Alternatively,
corn volunteers contain ing only the Pioneer 4114 Maize traits easily could be controlled by mechanical cultivation as well as readily available herbicides, including glyphosate, or other graminicid es ( Wozniak, 2002 ) , provided that the Pioneer 4114 Maize or its progeny does not carry resistance to these other herbicides (e.g., accidental admixture or intentional or unintentional crossing of resistant varieties). As discussed in Subsection 2.4.2.2

– Corn as a Weed or Volunteer , herbicides recommended for control of volunteer corn in soybeans are the
129DRAFT PIONEER 4114 MAIZE

ACCase inhibitors and certain ALS inhibitors. The ACCase inhibitors include two families of he rbicides, the AOPP ACCases (e.g., the “fops,” such as quizalofop, fenoxaprop, and diclofop) and the cyclohexanediones (e.g., the “dims,” such as clethodim and sethoxydim) ( Hager, 2009 )

. Pioneer 4114 Maize is sensitive to the herbicides recommended for control to volunteer corn. Future control of volunteer corn will require the grower to understand the corn variety which has given rise to the volunteer plants. Volunteer corn representing a hybrid contain ing the traits of Pioneer 4114 Maize and glyphosate resistance , for example, would still be controllable by the ACCase inhibitors and certain ALS Inhibitors noted above ( Hage r, 2009 )

. The ISHRW has identified several instances of weeds in the United States which show resistance to ACCase inhibitors and other modes of action ( Heap, 2012 ) . Adherence to the Stewardship Strategy is expected to minimize the development of weeds contain ing traits with resist ance to multiple herbicides ( Owen et al., 2011a ) . Although farmers may have to change their management strategies to adopt varietie s stacked with the Pioneer 4114 Maize traits, these changes will not necessitate a major departure from well

- established and broadly used agricultural protocols currently in use. Based on these findings, USDA

- APHIS has determined that there are no past, p resent, or reasonably foreseeable actions that would aggregate with effects of the proposed action to affect plants associated with the determination of nonregulated status of Pioneer 4114 Maize.
5.11 CUMULATIVE IMPACTS: SOIL MICROORGANISMS
A determination of n onregulated status of Pioneer 4114 Maize is not expected to result in changes to current corn cropping practices. Stacked hybrids combining the traits of Pioneer 4114 Maize with nonregulated glyphosate

resistant varieties would allow the application of gl yphosate to Pioneer 4114 Maize in addition to glufosinate ( Pioneer, 2012 ) . As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , the cultivati on of corn hybrids presenting the traits of Pioneer 4114 Maize and glyphosate resistance are already commercially available in the form of hybrids based on the 1507 x 59122 hybrid ( Pioneer, 2012 ) . No impacts to soil microorganisms have been reported associated with the commercial cultivation of this variety. Microorganisms produce aromatic amino acids through the shikimate pathway, similar to plants ( USDA

- FS, 2003 ) . Because glyphosate inhibits this pathway, it could be expected that glyphosate would be toxic to microorganisms. However, field studies show that glyphosate has little effect on soil microorganisms; and, in some cases, field studies have shown an increase in microbial activity due to the presence of glyphosate ( USDA

- FS, 2003 ; Duke et al., 2012 )

. Glyphosate use has been identified as potentially causing increases in certain disease

- causing microbes ( Fernandez et al., 2009 ; Kremer, 2010 ; Duke et al., 2012 ) . However, reported increases in infections from pathogenic soil fungi have been determined to be more closely related to reduced tillage and continuous cropping using herbicid e
- resistant crops, rather than application of glyphosate ( Fernandez et al., 2009 ; Duke et al., 2012 )

.

130DRAFT PIONEER 4114 MAIZE

Shan et al. ( Shan et al., 2008 ) demonstrated that negligi ble levels of Cry1F toxins remained i n soil following three years of continuous 1507 corn planting , suggesting that 1507 corn culture does not result in accumulation of the Cry1F toxin (Shan et al., 2008). Similar findings were obtained in a three

- year stu dy of MON88017 culture on soil levels of Cry3Bb1 . This field study also compared rhizosphere bacteria in Bt corn fields and non

- Bt corn fields, and found no significant differences ( Miethling

- Graff et al., 2010 )

. Based on these factors, USDA

- APHIS has determined that there are no past, present, or reasonably foreseeable actions that would aggregate with effects of the proposed action to affect soil microorganisms.
5.12 CUMULATIVE IMPACTS: BIOLOGICAL DIVERSITY A determination of nonregulated status for P ioneer 4114 Maize is not expected to result in changes in corn cultivation practices. Corn expressing the Cry proteins in Pioneer 4114 Maize has been cultivated commercially for many years. The commercial hybrid 1507 x 59122 Maize has been available in the market since 2006 ( Pioneer, 2012 ) . Glufosinate is approved for use on
corn ( Bayer, 2012 ) ; glyphosate

- resistant corn has been cultivated commercially since 1996 ( see, http://www.aphis.usda.gov/biotechnology/not_reg.html ) . The glyphosate

- resistant varieties are already widely cultivated, based on the percentage of corn currently treated with glyphosate (noted in Subsection 2.2

– Agronomic Inputs as 66 % of the acreage, ~ 57 million pounds) ( USDA

- NASS, 2011b ; USDA

- NASS, 2011a )

. As noted in the introduction to this section, glyphosate is not an approved tank mix partner with glufosinate for weed control in corn ( see, e.g., Bayer, 2012 ) . When growers adopt a stacked hybrid and elect to use both herbicides, the herbicides are applied sequentially, in accordance with label instructions, as part of the grower’s weed management strategies ( see, e.g., Monsanto, 2009 )

. Tank mixes of glufosinate and glyphosate are in use for control of weeds in no

- tillage weed control programs of certain crops . For example, glyphosate is a registered tank

- mix ture partner with glufosinate in the L iberty ® cotton varieties ( Koger et al., 2007 )

. US

- EPA ’s review of pesticides takes into account potential non

- target impacts. Total amounts of both herbicides applied to corn would be consistent with the label appli cation rates. Pioneer has committed to develop an appropriate stewardship plan for corn varieties contain ing multiple herbicide resistance events ( Pioneer, 2012 )

. Potenti ally, Pioneer could add other insect

- resistant traits with 4114. Effects on biodiversity of some of this traits have been examined previously : for example, corn stacked with Cry1Ab and Vip3Aa20 resulted in no significant differences between predator diver sity and abundan ce, and fields planted with this stack were had a significantly more diverse arthropod community composition than fields treated with pyrethroids ( Dively, 2005 ) . Similarly, arthropod community composition did not significantly differ between fields planted with 1507 corn and fields planted with conventional corn (Higgins et al., 2009) . A recent study focused specifically on syrphid diversity and abundance in MO N88017 fields, MON8903 fields, and fields with both traits stacked together; there were no significant differences between them ( Rosca and Cagan, 2013 )

.

131DRAFT PIONEER 4114 MAIZE

Based on these factors, USDA

- APHIS has determined that there are no past, present, or reasonably foreseeable actions that would aggregate with effects of the proposed action to affect biodiversity.
5.13 CUMULATIVE IMPACTS: GENE MOVEMENT
5.13.1 Vertical Gene Flow
USDA

- APHIS has considered the potential cumulative impacts of vertical gene flow associated with a new stacked variety. As noted in Subsection 4.4.5

– Gene Movement , the possibility of gene movement from the host plant into native or feral populations of Zea species or wild or weedy relatives o f corn has been evaluated by the US

- EPA and determined not to be a concern in the continental United States ( US

- EPA, 2010e )

. USDA

- APHIS has further considered vertical gene flow in its previous ana lysis in Subsection 4.2.3

– Organic Corn Farming and Specialty Corn Systems , and has determined that standard management methods are available to control pollen drift in order to manage vertical gene flow. These methods include having measures in place as part of seed certification and varietal protection to restrict pollen movement and gene flow between cornfields through the use of isolation distances, border and barrier rows, the staggering of planting dates, detasseling and hand pol lination, and various seed handling, transportation and handling procedures ( Wozniak, 2002 ; Mallory

- Smith and Sanchez

- Olguin, 2011 )

. Additionally, USDA

- APHIS has previously considered the factors limiting gene movemen t between corn varieties related to weediness. As noted in Subsection 4.4.5

– Gene Movement , neither GE nor non

- GE corn cultivars form self

- sustaining populations outside of cultivation because of limitations in seed dispersal, germination, and seasonal re quirements ( US

- EPA, 2010e )

. As noted in the introduction to this section, there are several commercial hybrid varieties containing both glyphosate

- and glufosinate

- resistant traits ; the cultivation of these varieties has not been reported to require a change in practices used to reduce vertical gene movement. There is no evidence to suggest that the stacking of the events conferring glyphosate resistance in a Pioneer 4114 Maize hybrid would require changes to the standard management measures or result in a change in the viability of corn cultivars outside of cultivation. Based on these findings, USDA

- APHIS has not identified any cumulative impacts to vertical gene flow associated with potential stacking with a glyphosate resistance event.
5.13.2 Horizontal Gene Transfer Based on available scientific evidence, USDA

- APHIS has not identified any cumulative impacts
o n horizontal gene movement that would occur from a determination of nonregulated status of Pioneer 4114 Maize.
As discussed in Subsection 4.4.5.2

– Horizontal Gene Transfer , the movement of genes to unrelated species is highly unlikely. USDA

- APHIS has con sidered horizontal gene transfer for multiple corn varieties and has found no evidence of naturally occurring transgene movement from GE crops to sexually incompatible species ( USDA

- APHIS, 2012e )

. Horizontal gene 132DRAFT PIONEER 4114 MAIZE

transfer, resulting in the horiz ontal relocation of entire transgenes between unrelated species, including the regulatory portions of the DNA (those parts of the DNA which code for the production of the specific proteins in that relocated transgene), has been shown to occur in nature
ove r very long timelines ( Clarke, 2007 ; Stewart, 2008 ) . There is no evidence to suggest that the stacking of the events conferring glyphosate resistance in Pioneer 4114 Maize would alter this conclusion. Based on these findings, USDA

- APHIS has not identified any cumulative impacts to hori zontal gene transfer associated with potential stacking with a glyphosate resistance event.
5.14 CUMULATIVE IMPACTS: HUMAN HEALTH The potential human health effects from the cultivation of glyphosate

- resistant crops, with a corresponding analysis of the implications of the use of glyphosate, have been evaluated thoroughly in other EAs since the 1993 introduction of the first glyphosate

- resistant crop product. (See: http://www.aphis.usda.gov/biotechnology/not_reg.html .) Glyphosate has been widely used on corn since the first glyphosate

- resistant corn variety in 1996 was determined to be no longer subject to the regulatory requirements of 7 CFR P art 340 or the plant pest provisions of the Plant Protection Act of 2000 (see Petition No. 96

- 317

- 01p, Monsanto’s Glyphosate

- resistant and European Corn Borer

- resistant Corn, at http://ww w.aphis.usda.gov/biotechnology/not_reg.html ). The use of glyphosate herbicide does not appear to result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals. Under present and expected use conditions, and when u sed in accordance with the US

- EPA label, glyphosate does not pose a health risk to humans ( US

- EPA, 1993b )

. US

- EPA has established pesticide residue tolerances for glyphosate including concentratio n benchmarks for field corn for forage, grain, and stover ( US

- EPA, 1993b ; US

- EPA, 2011a ) . Additionally, US

- EPA has already considered registratio n issues in a stacked corn product expressing both the PAT and the EPSPS proteins in its analysis of the Genuity ® SmartStax ® product ( see US

- EPA, 2011c )

. As noted in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , these stacked products are already cultivated. USDA

- APHIS assumes that applications of glyphosate to a stacked corn variety incorporating the Pioneer 4114 Maize traits will be conducted consistent with the label and consistent with the pesticide residue tolerances.
As discussed in Subsection s 4.5 .1 and 4. 5.2 (H uman Health and Worker Safety, respectively) , Pioneer has determined that Pioneer 4114 Maize is the compositional equivalent of the conventional corn foundation varieties (e.g. , 1507, 59122, and 1507 x 59122) ( Pioneer, 2011b ; US DA

- APHIS, 2012e )

. Similar comparisons have been conducted by petitioners for all of the other nonregulated corn varieties with which Pioneer 4114 corn is likely to be stacked ( see, e.g., APHIS PPRA and EA for the corn varieties presented on http://www.aphis.usda.gov/biot echnology/petitions_table_pending.shtml )

. In each of these previous reviews, the US

- FDA also has completed a consultation, including the most recent completed consultation for a CP4

- EPSPS based glyphosate

- resistant corn presented by Stine Seed ( see, e.g., US

- FDA, 2012 )

. In these consultations, the US

- FDA notes that the presence of the EPSPS pr otein does not give rise to any food or feed concerns. Humans are already exposed to the EPSPS protein in these glyphosate

- resistant varieties. US

- EPA has published an exemption from tolerance for the CP

- 4 EPSPS protein in all plants ( US

- EPA, 2007c ) as well as tolerances for glyphosate residues ( see US

- EPA, 1980 ) . It is highly unlikely that a conventional 133DRAFT PIONEER 4114 MAIZE

hybrid stack of Pioneer 4114 Maize with a glyphosate

- resistant variety would substantially change the composition of the resulting corn variety.

Bt corn has been found to have signific antly fewer mycotoxins than conventional corn, which may have a benefic ial impact on human health ( Meissle et al., 2011 )

. Based on these factors, no substantial cumulative impacts to human health related to the No Action Alternative or a determination of nonregulated status of Pioneer 4114 Maize are expected, and no cumulative impacts have been ident ified.
5.15 CUMULATIVE IMPACTS: WORKER SAFETY
As discussed in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , the cultivation of Pioneer 4114 Maize is limited to development as a foundation stock for the development of breeding pyramids or stacks with other herbicide

- resistant and insect

- resistant corn events. As discussed in Subsection 5.2

– Cumulative Impacts: Areas and Acreage of Corn Production , cultivation of a stacked variety presenting resistance to the two herbicides is not expected to increase the total acreage of corn production or the cultivation of other varieties of corn. Cumulative worker safety issues related to the continued use of US

- EPA registered pesticides during conventional and GM corn production, including cult ivation of hybrids should remain the same as the current condition

. The corn varieties with which Pioneer 4114 Maize is expected to be hybridized are already commercialized, and the herbicides and insecticidal properties associated with these products have already been evaluated and approved by USDA

- APHIS , the US

- FDA , and the US

- EPA

. As discussed in Section 4. 5

– Public Health , a n indirect benefit to worker safety arises from the cultivation of Bt corn varieties, in the reductions of applications of insect icides ( US

- EPA, 2010b ; US

- EPA, 2010a ; US

- EPA, 2010f )

. As noted in Subsections 2.2.2

– Agronomic Practices , and 4.5.1

– Human Health , there has been a decline in the use of soil and foliar insecticides due, in part, to the adoption of Bt crops ( Brookes et al., 2012 )

. This trend is unlikely to change with the introduction of another corn hybrid combini ng the Pioneer 4114 Maize with a glyphosate

resistant hybrid. The potential effects from the cultivation of glyphosate

- resistant crops, with a corresponding analysis of the implications of the use of glyphosate, have been evaluated thoroughly in other USD A

- APHIS EAs since the 1993 introduction of the first glyphosate

- resistant crop product. (See: http://www.aphis.usda.gov/biotechnology/not_reg.html .) Glyphosate has been widely used
on cor n since the first glyphosate

- resistant corn variety in 1996 was determined to be no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act of 2000 (see Petition No. 96

- 317

- 01p, Monsanto’s Gl yphosate

- resistant and European Corn Borer

- resistant Corn, at http://www.aphis.usda.gov/biotechnology/not_reg.html ). The use of glyphosate herbicide does not appear to result in adverse e ffects on development, reproduction, or endocrine systems in humans and other mammals ( US

- EPA, 1993b ) . Under present and expected use conditions, and when used in accordance with the US

- EPA label, glyphosate does not pose a health risk to humans, including workers ( US

- EPA, 1993b )

. 134DRAFT PIONEER 4114 MAIZE

Based on these factors, no substantial cumulative impacts to worker safety related to the No Action Alternati ve or a determination of nonregulated status of Pioneer 4114 Maize are expected.
5.16 CUMULATIVE IMPACTS: ANIMAL FEED The potential animal feed and animal health effects from the cultivation of glyphosate

- resistant crops, with a corresponding analysis of the implications of the use of glyphosate, have been evaluated thoroughly in other USDA

- APHIS EAs since the 1993 introduction of the first glyphosate

- resistant crop product, and are summarized in Subsection 4.2.2

– Agronomic Practices (see: http://www.aphis.usda.gov/biotechnology/not_reg.html ). The use of glyphosate herbicide does not appear to result in adverse effects on development, reproduction, or endocrine systems in animals ( US

- EPA, 1993b ) . In animals, most glyphosate is eliminated in feces and urine ( US

- EPA, 1993b ) . Under pr esent and expected use conditions, and when used in accordance with the US

- EPA label, glyphosate does not pose a health risk to animals as an animal feed concern. Pesticide residue tolerances for glyphosate include concentration benchmarks for field corn f or forage, grain, and stover, and cover animal feed and animal tissues ( US

- EPA, 1993b ; US

- EPA, 2011a )

. USDA

- APHIS assumes that applications of gl yphosate to a stacked corn variety incorporating the Pioneer 4114 Maize traits will be conducted consistent with the label and consistent with the pesticide residue tolerances.
As discussed in Subsection s 4.5 .1 and 4. 5.2 (Human Health and Worker Safety, re spectively) , Pioneer has determined that Pioneer 4114 Maize is the compositional equivalent of the conventional corn foundation varieties (e.g. , 1507, 59122, and 1507 x 59122) ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. Similar comparisons have been conducted by petitioners for all of the other nonreg ulated corn varieties with which Pioneer 4114 corn is likely to be stacked ( see, e.g., APHIS PPRA and EA for the corn varieties presented on http://www.aphis.usda.gov/biotechnology/petitions_t able_pending.shtml )

. As noted in Subsection 5.14

– Cumulative Impacts: Human Health , in each of these previous reviews, the US

- FDA also has completed a consultation, including the most recent completed consultation for a CP4

- EPSPS based glyphosate

- resis tant corn presented by Stine Seed ( see, e.g., US

- FDA, 2012 )

. In these consultations, the US

- FDA notes that the presence of the EPSPS protein does not give rise to any animal feed concerns. Animals are already exposed to the EPSPS protein in these glyphosate

- resistant varieties. US

- EPA has published an exemption from tolerance for the CP

- 4 EPSPS p rotein in all plants ( US

- EPA, 2007c ) as well as tolerances for glyphosate residues for corn and corn products used in animal feed ( see US

- EPA, 1980 )

. It is highly unlikely that a conventional hybrid stack of Pioneer 4114 Maize with a glyphosate

- resistant variety would substantially change the composition of the resulting corn variety.
Should Pioneer stack 4114 with other insect

- resistant traits in th e future, there is no evidence of adverse effects to ani mal feed for Bt corn . For example, Lundry et al. ( Lundry et al., 2013 ) found that SmartStax corn used for forage and animal feed was compositionally similar to conventional corn forage and animal feed. Simil ar results were obtained by McCann et al. ( McCann et al., 2007 ) in compositional analyses of MON88017 corn feed versus conven tional corn feed.

135DRAFT PIONEER 4114 MAIZE

There is no evidence of negative growth and performance of animals fed Bt corn. A study of broiler chicken growth and survivorship following diets of either conventional corn or Bt 11 corn found no significant differences ( Brake et al., 2003 ) , and Haryu et al. ( Haryu et al., 2009 ) found similar results in a feeding study using mic e . There were no significant growth differences between cattle fed MON89034 corn and conventional corn ( Weber et al., 2011 )

. Based on these factors, no cumulative impacts to animal feed have been identified related to the determination of nonregul ated status of Pioneer 4114 Maize.
5.17 CUMULATIVE IMPACTS: DOMESTIC ECONOMIC ENVIRONMENT
Based on the information described in Subsection 4.7.1

– Domestic Economic Environment , USDA

- APHIS concludes that a determination of nonregulated status of Pioneer 4114 Maize in itself will have no foreseeable adverse cumulative domestic economic effects.
As discussed in Subsection 4.2

– Agricultural Production of Corn , Pioneer intends to limit the
cu ltivation of Pioneer 4114 Maize to use as a foundation breeding stock for developing stacked or pyramided hybrids, combining the Pioneer 4114 Maize traits with corn varieties no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant p est provisions of the Plant Protection Act of 2000. For the purposes of this cumulative impacts analysis, USDA

- APHIS focuses its analysis on hybridization with a glyphosate

- resistant corn variety for the reasons described in Subsection 5.1

– Assumptions Us ed for Cumulative Impacts Analysis

. As discussed in Subsection 5.1

– Assumptions Used for the Cumulative Impacts Analysis , similar stacked varieties are already on the market. These varieties have the potential to improve grower management strategies for control of glyphosate

- resistant weeds, and also improve grower economics. For example, a stacked hybrid combining both herbicide resistance traits would allow a grower to apply herbicides with two different modes of action. This herbicide management strate gy is anticipated to sustain the long

- term viability of the glyphosate

- resistant cropping system and preserve the benefits it provides to growers, the agricultural industry, and society. The adoption of such a diverse weed management strategy, incorporatin g several herbicides with alternative modes of action, may cost more initially than the conventional single

herbicide approach, but these costs are offset by an increase in yields in those fields where the weed pressure has been reduced ( Weirich et a l., 2011 ) . There also is an inherent reduction in grower costs associated with a reduction in frequency of herbicide applications and in the continued avoidance of tillage through careful herbicide applications. The volume of herbicides applied to corn, and the chemical composition of those herbicides, may change as a result of such stacked varieties. As discussed in Section 2

– Affected Environment , in 2005, 31% of the corn acreage was treated with glyphosate, and glufosinate use has been less than 6% o f the acreage. As discussed in Subsection 4.7.1.2

– Preferred Alternative: Domestic Economic Environment , to the extent that the planting of hybrids based on Pioneer 4114 Maize results in a substitution of glufosinate or glyphosate for other herbicide appl ications to manage hard to control weeds, those who have reduced or eliminated these multiple herbicide applications or avoided a reversion to tillage to control these weeds might experience reduced input costs and a commensurate increase in net income.

136DRAFT PIONEER 4114 MAIZE

Th e cultivation of a stacked hybrid contain ing the traits from Pioneer 4114 Maize and resistance to glyphosate is not likely to impact grower demands for stacked products. Corn contain ing herbicide

- resistant and insect

- resistan t traits is already cultivated on 52% of the United States acreage, with single trait corn only cultivated on 36% (21% herbicide

- resistant and 15% insect

resistant) ( USDA

- NASS, 2012b ) . Additionally, corn cont ain ing the traits from the Pioneer 4114 Maize foundation stock, 1507 and 59122, already are cultivated on over 16% of domestic corn acreage. Based on these factors, no net negative cumulative impacts on domestic economics have been identified associated with the cultivation of Pioneer 4114 Maize. If growers adopt the stacked variety and take advantage of the weed management strategy incorporating herbicides with different modes of action to control glyphosate

- resistant weeds, local farm economics may improv e. 5.18 CUMULATIVE IMPACTS: TRADE ECONOMIC ENVIRONMENT
Current and historic economic evidence indicates that herbicide

- resistant corn technology has the potential to increase domestic production at lower cost. This trend of lower production costs could enhance international corn trade by making U.S. corn and corn products more competitive in the global market.
As noted in Subsection 4.7.2.2

– Preferred Alternative: Trade Economic Environment , Pioneer intends to submit applications to several international agen cies prior to initiating commercial launch of the Pioneer 4114 Maize products ( Pioneer, 2011b )

. Commercial launch of a stacked hybrid would be premised on the approval of t he individual components of the hybrid, such as in Argentina, where the review focuses only on new aspects presented by the stack ( Stein and Rodrigues

- Cerezo, 2009 ) , although other countries, e.g., Brazil and the EU, currently require specific approval for stacked hybrids ( Stein and Rodrigues

- Cerezo, 2009 ; James, 2011 )

. As of 2011, 26% of the total global lands committed to agriculture were cultivated with stacke d varieties ( James, 2011 )

. Based on the information described in Section 4

– Environmental Consequences , USDA

- APHIS has determined that there are no past, present, or reasonable foreseeable actions that in aggregate with effects of the proposed action would n egatively impact the trade economic environment

.

137DRAFT PIONEER 4114 MAIZE



### 6 THREATENED AND ENDANGERED SPECIES
6.1 USDA
- APHIS ’ APPROACH TO EVALUATION OF POTENTIAL IMPACTS TO THREATENED AND ENDANGERED SPECIES Congress passed the Endangered Species Act (ESA) of 1973, as amended, to preve nt 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 a nd 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 pro tection 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 Federa l 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 resu lt in the destruction or adverse modification of designated critical habitat. It is the responsibility of the Federal agency taking the action to assess the effects of their action and to consult with the USFWS and NMFS if it is determined that the action “may affect” listed species or critical habitat. To facilitate USDA

- APHIS ’ ESA consultation process, USDA

- APHIS met with the USFWS from 1999 to 2003 to discuss factors relevant to USDA

- APHIS ’s regulatory authority and effects analysis for petitions for nonregulated status, and developed a process for conducting an effects determination consistent with the Plant Protection Act of 2000 (Title IV of Public Law 106

- 224). This process is described in a decision tree document, which is presented in Appendix C

. USDA

APHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions.
USDA

- APHIS ’ regulatory authority over GE org anisms under the Plant Protection Act of 2000 is limited to those GE organisms for which it has reason to believe might be a plant pest or those for which USDA

- APHIS does not have sufficient information to determine that the GE organism is unlikely to pose a plant pest risk (7 CFR §340.1). USDA

- APHIS does not have authority to regulate the use of any herbicide, including glufosinate. After completing a PPRA , if USDA

138DRAFT PIONEER 4114 MAIZE

APHIS determines that Pioneer 4114 Maize does not pose a plant pest risk, then Pioneer 4114 Maize would no longer be subject to the plant pest provisions of the Plant Protection Act of 2000 or to the regulatory requirements of 7 CFR Part 340, and therefore, USDA

- APHIS must reach a determination that the article is no longer regulated. As part of its EA analysis, USDA

- APHIS is analyzing the potential effects of Pioneer 4114 Maize on the environment including any potential effects to threatened and endangered species and critical habitat. As part of this process , USDA

APHIS thoroughly reviews the ge netically engineered product information and data related to the organism (generally a plant species, but also may be other genetically engineered organisms). For each transgene/transgenic plant, USDA

- APHIS considers the following:

• Reviews of the biology and taxonomy of the crop plant and its sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;

• Location(s) of the new transgene and its products (if any) produced in the plant and their quantity;

• Reviews of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;

• Concentrations of any known plant toxicants, if applicable;

• Sexual compatibility of the transgenic plant with any threatened or endangered species (TES) of plants or a host of any TES; and

• Any other information that may inform the potential for an organis m to pose a plant pest risk.
6.2 POTENTIAL EFFECTS OF THE CULTIVATION OF PIONEER 4114 MAIZE ON TES In following this review process, USDA

- APHIS , as described below, has evaluated the potential effects that a determination of nonregulated status of Pioneer 4114 Maize plants may have, if any, on Federally

- listed TES and species proposed for listing, as well as designated critical habitat and habitat proposed for designation. Pioneer’s studies demonstrate that agronomic characteristics and cultivation practices r equired for Pioneer 4114 Maize are essentially indistinguishable from practices used to grow other corn varieties, including other herbicide

- resistant varieties ( Pioneer, 2011b ; USDA

- APHIS, 2012e )

. Pioneer 4114 Maize will be cultivated only as a foundation seed stock for the development of other hybrids, and hybrids based on Pioneer 4114 Maize are expected to replace other varieties of corn currently cultivated ( Pioneer, 2011b ; Pioneer, 2012 ) . As noted in Subsection 2.2

– Agricultural Production of Corn , corn is cultivated commercially in each of the continental United States. USDA

- APHIS considered the potential for Pioneer 4114 Maize to extend the range of corn production and also the potential to extend agricultural production into new natural
areas. As discussed in Subsection 4.2

– Agricultural Production of Corn, USDA

- APHIS has determined that P ioneer 4114 Maize and hybrids based on this variety are unlikely to extend the range of corn production. Moreover, New acreage is not expected to be developed to accommodate the cultivation of hybrids based on Pioneer 4114 Maize ( Pioneer, 2011b )

. 139DRAFT PIONEER 4114 MAIZE

Accordingly, the issues discussed herein focus on the potential environmental consequences of the determination of nonregulated status of Pioneer 4114 Maize on TES species and crit ical habitat in the areas where corn is grown. Based upon the scope of the EA and production areas identified in the Affected Environment section of the EA, USDA

- APHIS obtained and reviewed the USFWS list of TES species (listed and proposed) for each state where corn is commercially produced from the USFWS Environmental Conservation Online System ( ECOS; as accessed 4/15/2011 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp )

. USDA

- APHIS focused its TES effects analysis on the implications of ex posure to the Cry and PAT proteins in corn, the interaction between TES and the Pioneer 4114 Maize plant including potential for sexual compatibility and ability to serve as a host for a TES (Subsection 6.2.1

– Potential Effects of Pioneer 4114 Maize on TES ); and as part of its NEPA analysis considered the potential impacts of the use of glufosinate herbicide to non

- target organisms and the natural environment (Subsection 6.2.2

– Potential Effects of the Use of Glufosinate Herbicides)

. 6.2.1 Potential Effects of Pioneer 4114 Maize on TES After reviewing the list of threatened and endangered plant species in the States where corn is grown, USDA

- APHIS determined that Pioneer 4114 Maize would not be sexually compatible with any listed TES plant species or plant proposed for listing as none of these listed plants are in the same genus nor are known to cross pollinate with species of the genus Zea

. USDA

- APHIS considered the possibility that Pioneer 4114 Maize could serve as a host plant for
a TES species. A review of the species list reveals that there are no members of the genus Zea that serve as a host plant for any TES

. Pioneer has presented data evaluating the agronomic and morphological characteristics of Pioneer 4114 Maize, including co mpositional and nutritional characteristics, safety evaluations and toxicity tests, comparing the product to a conventional hybrid corn variety ( Pioneer, 2011b )

. Compositio nal elements compared included moisture, protein, fat, carbohydrates, ash, minerals, dietary fiber, essential and non

- essential amino acids, fatty acids, vitamins, and anti

- nutrient s ( Pioneer, 2011b ) . Allergenicity and toxicity studies included bioinformatics analyses, digestibility and acute protein toxicity studies ( Pioneer, 2011b ) . No stat istically meaningful differences were observed when comparing Pioneer 4114 Maize with the near isoline variety ( Pioneer, 2011b ; USDA

- APHIS, 2012e ) . Pioneer 4114 Maize does not appear to present any changes in agronomic inputs , morphological characteristics or composition that would affect TES. The Cry proteins in Pioneer 4114 Maize are derived from Bt , subsp. a izawai (Cry1F) and Bt strain PS149B1 (Cry 34Ab1 and Cry35Ab1) ( USDA

- APHIS, 2012e ) . The modifying PAT enzyme, encoded by the pat gene, is derived from S. viridochromogenes ( Pioneer, 2011b ) . Both B. thuringiensis and S. viridochromogenes are naturally occurring soil bacteri a and are not pathogenic. Animals are regularly exposed to these organisms and their components without

140DRAFT PIONEER 4114 MAIZE

adverse consequences ( Hérouet et al., 2005 ; US

- EPA, 2010b ; US

- EPA, 2010a ; US

- EPA, 2010c ; Pioneer, 2011b ; US

- EPA, 2012d )

. As noted throughout this document, the traits ass ociated with Pioneer 4114 Maize are nonregulated and have been cultivated commercially for many years. The Cry1F protein and its associated genetic elements are identical to those in 1507 Maize , which had a determination of nonregulated status by USDA, reg istered by the US

- EPA , and reviewed by the US

- FDA in 2001 ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- EPA, 2010f ; Pioneer, 2011b ) . The binary Cry proteins, Cry34Ab1 and Cry35Ab1, and their associated genetic elements are identical to those in 59122 Maize, which was reviewed by US

- FDA in 2004, had a determination of nonregulated status by USDA in 2005, and registered by US

- EPA since 2005 ( US

- FDA, 2004 ; USDA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 2011b ) . Maize expressing the PAT protein has had a nonregulated status since 1995 and cultivated commercially in the United States since 1996 ( USDA

- APHIS, 1995 ) . The safety of the introduced proteins in Pioneer 4114 Maize has been evaluated previously by USDA

- APHIS , the US

- FDA and the US

- EPA , and there is a history of safe use and exposure. There are no r eports of potential impacts to TES or critical habitat associated with exposure to these proteins.
As discussed in Subsection 2.4.3

– Soil Microorganisms, there is little evidence that soil microorganisms or soil ecosystem level processes are negatively impacted by Bt proteins in soil or by the cultivation of GE crops ( Icoz and Stotzky, 2008 ) . Because of concerns of the potential impacts of cultivating GE crops with Bt proteins on soil communities, the decomposition rates of GE crops with Bt proteins versus non

- GE crops have been studied ( Icoz and Stotzky, 2008 )

. Studies conducted u nder field conditions show the decomposition rates of Bt cotton and Bt corn did not differ from the decomposition rates of non

- Bt cotton and corn ( Lachnicht et al., 2004 ; Tarkalson et al., 2007 )

. Concerns have been raised regarding the potential exposure of non

- target organisms to the Cry proteins. Pioneer has presented information on laboratory studies testing the potential impacts to representative species of interest and surrogate species ( Pioneer, 2011b ) . Surrogate species are typically selected because they are amenable to the laboratory setting; are environmentally sensitive and representative of the agroecosystem; and can be used to predict potential impacts on related non

‐ target organisms, including beneficial, threatened, or endangered species ( Romeis et al., 2011 ) . Surrogate species also are used because testing on TES is not permitted. The insecticidal Cry1F and Cry34/35Ab1 proteins have been assessed by laboratory studies to evaluate the specificity of these proteins to target insects. In general, only insect species within a given taxonomic order and closely related families are susceptible to a given insecticidal protein ( Pioneer, 2011b ) . Cry1F is US

- EPA labeled for protection against lepidopterans (butterflies and moths) and coleopterans (beetles). Target species of Lepidoptera include the European corn borer ( O

. nubilalis ), fall armyworm ( Sp odoptera frugiperda ), corn earworm ( Helicoverpa zea ), western bean cut worm ( Striacosta albicosta ( Smith) ), black cutworm ( Agrotis ipsilon ), lesser corn stalk borer ( Elasmopalpus lignosellus ), southwestern corn borer ( Diatraea grandiosella ), and sugarcane borer ( Diatraea saccharalis ) ( US

- EP A, 2010b ) . Cry34/35Ab1 is US

- EPA labeled for protection against Coleoptera, specifically northern corn rootworm ( Diabrotica barberi ), western corn rootworm ( D. virgifera virgifera ), and Mexican corn rootworm ( D. virgifera zeae ) 141DRAFT PIONEER 4114 MAIZE

( US

- EPA, 2010a ) . Cry34/35Ab1 also has activity for southern corn rootworm ( Diabrotica undecimpunctata howardi ) as determined by use in bioassays ( US

- EPA, 2010a )

. Pioneer has presented the results of laboratory assays in which springtail and earthworms were exposed to the Cry proteins ( Pionee r, 2011b ) . None of the soil dwelling species tested showed substantial adverse effects from the proteins and the margins of exposure were greater than 22

‐ fold ( Pioneer, 201 1b ) . Additionally, soil dwelling non

‐ target organisms are unlikely to be exposed to concentrations of the Cry1F and Cry34/35Ab1 proteins in soil, as realistic environmental exposures are expected to be substantially lower based on protein degradation an d lack of accumulation in soil ( Pioneer, 2011b )

. Pioneer also has presented the results of laboratory assays in which representatives of coleopteran and lepidopteran specie s, targeted insect orders, as well as representatives of other insect orders not considered targets, were exposed to purified Cry proteins ( Pioneer, 2011b ) . The representat ive coleopteran species were the Ladybird beetle ( H

. convergens and C

. maculata ), the representative lepidopteran species was the Monarch butterfly ( D

. plexippus ), and insects representing other orders were parasitic wasps ( N

. vitripennis ), the green lacew ing ( C

. carnea ), and the honeybee ( A. mellifera ) ( Pioneer, 2011b )

. In addition, a representative of a non

- target invertebrate order was tested, th e water flea ( Daphnia magna ) ( Pioneer, 2011b ) . None of the tested species showed significant adverse effects from exposure to the proteins ( Pioneer, 2011b )

. Previous assessments of the Cry proteins in 1507 and 59122 Maize have found no impacts to TES ( USDA

- APHIS, 2001 ; USDA

- APHIS, 2005 ; US

- EPA, 2010b ; US

- EPA, 2010a ) . As of August 2012, 62 insect speci es are listed on the USFWS website as TES ( US

- FWS, 2012 )

. Twenty

‐ two of these insects are Lepidoptera and 17 are Coleoptera, with the remaining representing insects of other orders. With the exception of two coleopteran species, the Salt Creek Tiger Beetle ( Cicindela nevadica lincolniana ) ( US

- FWS, 2010 ; US

- FWS, 2011b ) and the Casey’s June Beetle ( Dinacoma caseyi ) ( US

- FWS, 2011a ) , all of the species of Lepidoptera and Coleoptera currently listed were added prior to the granting of nonregulated status of 1507 and 59122 Maize. Of the two newly listed species, only the Salt Creek tiger beetle, added to the TES list in 2005 ( US

- FWS, 2010 ; US

- FWS, 2011b ) , is found in the Corn Belt. This beetle is found in Nebraska (Lancaster and Saunders counties), the third largest state for maize cultivation ( US

FWS, 2010 ; US DA

- NASS, 2012b ) . However, the beetle’s critical habitat has been characterized
as non ‐ vegetated stream banks or edges that are in saline or freshwater wetlands and the beetles prefer to be within a few meters of these. In addition, the Salt Creek Beetle is a member of the Carabidae beetle family, which is unrelated to the corn rootworm family, the Chrysomelidae. Therefore, it is unlikely that the Salt Creek tiger beetle will be exposed to the Cry34/35Ab1 protein from 4114 Maize or will be impacted due to the specificity of the Cry34/35Ab1 protein to corn rootworm species. The Casey's June beetle is found only in one area in the United States near Palm Springs, California ( US

- FWS, 2011a ) . This beetle's preferred habitat is sandy areas associated with desert scrub vegetation located on alluvial fans, much like the area it currently inhabits in Riverside County, California ( US

- FWS, 2011a ) . Although corn is grown in California, it is grown in counties farther north near San Francisco ( USDA

- NASS, 2012b ) . Based on preferred habitat, it is highly unlikely that these beetles will be exposed to the Cry34/35Abl protein from 4114 142DRAFT PIONEER 4114 MAIZE

Maize. US

- EPA also concluded that a review of the preferred habitats of other coleopter an species listed as endangered by the USFWS indicated that no exposure to harmful levels of the subject protein (Cry34/35Abl protein) would take place ( US

- EPA, 2010a ) due to the lack of exposure and geographical and habitat limitations. These other coleopteran species are located in
non
- corn production areas and/or their habitat does not encompass agricultural areas.
For 1507 Maize , USDA considered the impact of the Cry1F pro tein on two lepidopteran species, the Karner blue butterfly ( Lycaeides melissa samuelis ) and Mitchell’s satyr butterfly ( Neonympha mitchellii ) ( USDA

- APHIS, 2001 ) . USDA concluded that both species would not be expected to be present in or close to maize fields; therefore it is unlikely there would be any impact of 1507 Maize cultivation ( USDA

- APHIS, 2001 ) . For 59122 Maize, USDA considered the impact on one primary threatened and endangered coleopteran species, the American burying beetle, Nicrophorus americanus ( USDA

- APHIS, 2005 ) . Habitats in Nebraska where these beetles have been recently found consist of grassland prairie, forest edge and scrubland. From review of preferred habitats, this beetle is unlikely to be found in active maize fields and therefore would not be exposed su bstantially to the Cry34/35Ab1 protein from 4114 Maize ( USDA

- APHIS, 2005 )

. For other lepidopteran

- and corn rootworm

- resistant maize events, US

- EPA has made similar conclusions for the Karner blue b utterfly and the American burying beetle and has not identified any new TES that would be impacted by cultivation ( US

- EPA, 2009 ; US

- EPA, 2010b ; US

- EPA, 2010a ) . Furthermore, US

- EPA examined the habitats of the other threatened and endangered insect species in the orders Diptera, Hemipt era, Odonata and Orthoptera and found that they primarily occupy dune, meadow or prairie, or open forest habitats and are not closely associated with row crop production, often times due to the specificity of the habitat of their host plants ( US

- EPA, 2010b ; US

- EPA, 2010 a )

. Similar to the conclusions for 1507 and 59122 Maize, it is unlikely that threatened and endangered species such as the Karner blue and Mitchell’s satyr butterflies and the American burying beetle, Casey’s June beetle and the Salt Creek tiger beetles would be affected by 4114 Maize cultivation. Based on the constituent elements required in their habitat, Cry protein target insect specificity, and the lack of habitat overlap with regions of maize cultivation, cultivation of Pioneer 4114 Maize will have no effect on any listed threatened and endangered insects.
USDA

- APHIS also considered the potential for exposure to the PAT protein. The pat gene expressing the PAT protein in Pioneer 4114 Maize was derived from S. viridochromogenes , a gram
- positive soil bacterium ( Pioneer, 2011b )

. The PAT protein is identical to the protein found in many commercially

- available crops no longer subject to the plant pes t provisions of the Plant Protection Act of 2000 and 7 CFR Part 340 , including 1507 and 59122 Maize ( USDA

- APHIS, 2001 ; USDA

- APHIS, 2005 ) . Following a determination of nonregulated status in 1995, maize expressing the pat gene has been cultivated commercially in the United States sin ce 1996 ( USDA

- APHIS, 1995 ) . As with the discussion of the Cry proteins above, the PAT protein and i ts associated genetic elements are identical to those in 1507 Maize , which had a determination of nonregulated status by USDA, registered by the EPA , and reviewed by the US

- FDA in 2001 ( US

- FDA, 2001 ; USDA

- APHIS, 2001 ; US

- EPA, 2010f ; Pioneer, 2011b ) . The same PAT protein is present in 59122 Maize, which was reviewed by US

- FDA in 2004, had a determination of 143DRAFT PIONEER 4114 MAIZE

nonregulated sta tus by USDA in 2005, and registered by US

- EPA since 2005 ( US

- FDA, 2004 ; USDA

- APHIS, 2005 ; US

- EPA, 2010f ; Pioneer, 2011b ) . The US

- EPA has approved a tolerance exemption for the PAT protein and the genetic material necessary for its production in all plants ( US

- EPA, 2007a ) . No impacts to humans or animals have been identified associated with exposure to the pat gene or the PAT protein. The environmental safety of the PAT proteins has been extensively reviewed in international scientific, peer

- reviewed jou rnals ( Hérouet et al., 2005 ) . The PAT protein expressed in GM crops has been consumed by humans and animals since 1995 and have exhibited no significant adverse effects. The PAT protein mode of action is specific to the breakdown of ammonia in plant tissues. Because animals lack this enzymatic pathway ( Hérouet et al., 2005 ) , and there is no mechanism to transfer this gene to unrelated plant species, USDA

APHIS limits its analysis of the implications of exposure to the PAT protein to the potential for gene movement to related TES corn species. This analysis also is relevant to considerations for the movement of the Cry proteins.
As discussed in Gene Movement ( S ubsections 2.4.5 and 4.4.5 ) , the potential for gene movement between Pioneer 4114 Maize and related corn species is limited ( Pioneer, 2011b ) . As discussed in Subsection 2.1

– Corn Background Information , there is a rare, sparsely dispersed feral population of teosinte, a relative of Z. mays , reported in Florida ( USDA

- APHIS, 2012e ) ; however, this plant is not listed as a TES. Moreover, where maize x teosinte hybrid s have been identified in the field, they are found to exhibit low fitness and are unlikely to produce a second generation ( USDA

- APHIS, 2012e ) . None of the relatives of corn are Federally listed (or proposed) as endangered or threatened species ( US

- FWS, 2012 ) . The US

- EPA has concluded tha t there is no substantial risk for gene capture and expression of the Cry proteins in weedy or wild relatives of corn in the United States ( US

EPA, 2010e )

. Accordingly, a determination of nonregulation of Pioneer 4114 Maize will not result in the movement of the PAT or Cry proteins to endangered or threatened species related to corn. Pioneer 4114 Maize does not present a potential as a weed or the potential to displace a TES. The agron omic and morphologic characteristics data provided by Pioneer were used in the USDA

- APHIS analysis of the weediness potential for Pioneer 4114 Maize, and evaluated for the potential to impact TES. Agronomic studies conducted by Pioneer tested the hypothesi s that the weediness potential of Pioneer 4114 Maize is unchanged with respect to conventional corn ( Pioneer, 2011b ) . No differences were detected between Pioneer 4114 Maiz e and nontransgenic
near
- isoline corn in growth, reproduction, or interactions with pests and diseases, other than the intended effect of herbicide resistance ( USDA

- APHIS, 2012e ) . Corn possesses few of the characteristics of successful weeds, an d has been cultivated around the globe without any report that it is a serious weed or that it forms persistent feral populations ( USDA

- APHIS, 2012e )

. Based on the agronomic field data and literature survey on corn weediness potential, Pioneer 4 114 Maize is unlikely to affect TES as a troublesome or invasive weed ( Pioneer, 2011b ; USDA

APHIS, 2012e )

. In addition to evaluating Pioneer’s comparisons of Pioneer 4114 Maize with the non

- transgenic
near
- isoline hybrid vari ety for potential differences in agronomic characteristics and 144DRAFT PIONEER 4114 MAIZE

morphology, USDA

- APHIS also considers the US

- EPA and US

- FDA regulatory assessment in making its determination of the potential impacts of determination of nonregulated status of the new agricultural product. As discussed above in Animal and Plant Communities (Subsections 4.4.1 and 4.4.2, respectively) and Public H ealth (Subsection 4.5), Pioneer has submitted food and feed safety and nutritional assessments for Pioneer 4114 Maize to the US

- FDA . Exemptions from pesticide residue tolerance already exist for the Cry and PAT proteins ( US

- EPA, 2007a )

. After reviewing the possible effects of the nonregulation of Pioneer 4114 Maize, USDA

- APHIS has not identified any stressor that could affect the reproduction, numbers, or distribution of a listed TES or species propos ed for listing. As a result, a detailed exposure analysis for individual species is not necessary. USDA

- APHIS also considered the potential effect of the determination of nonregulated status of Pioneer 4114 Maize on designated critical habitat or habitat p roposed for designation, and could identify no differences from effects that would occur from the production of other corn varieties. Corn is not considered a particularly competitive plant species and has been selected for domestication and cultivation un der conditions not normally found in natural settings ( US

- EPA, 2010e )

. Based on these factors, USDA

- APHIS has concluded that the determination of nonregulated status of Pioneer 4114 Maize, and the corresponding environmental release of this corn variety will have no effect on listed species or species proposed for listing, and would not affect designated habitat or habitat proposed for designation. Because of this no

- effect determination, consultati on under Section 7(a)(2) of the Act or the concurrences of the USFWS or NMFS are not required.
6.2.2 Potential Effects of the Use of Glufosinate Herbicides
USDA

- APHIS met with USFWS officials on June 15, 2011 to discuss whether USDA

- APHIS has any obligations un der the ESA regarding analyzing the impacts of herbicide use associated with all GE crops on TES. As a result of these joint discussions, USFWS and USDA

- APHIS have agreed that it is not necessary for USDA

- APHIS to perform an ESA effects analysis on herbici de use associated with GE crops currently planted because US

- EPA has both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess pesticide effects on the environment under the FIFRA. USDA

- APHIS has no statutory authority to authorize or regulate the use of glufosinate, or any other herbicide, by corn growers. Under USDA

- APHIS ’ current Part 340 regulations, USDA

- APHIS only has the authority to regulate Pioneer 4114 Maize or any GE organism as long as USDA

- APHIS b elieves it may pose a plant pest risk. For GE organisms, USDA

- APHIS has no regulatory jurisdiction over any other risks associated with GE organisms including risks resulting from the use of herbicides or other pesticides on those organisms. Nevertheless, USDA

- APHIS is aware that there may be potential environmental impacts resulting from the use of glufosinate on Pioneer 4114 Maize, including potential impacts on TES and critical habitat, based on assessments provided to it by the US

EPA and as available i n the peer

- reviewed scientific literature. The following materials provide an overview of the US

- EPA ’s Endangered Species Protection Program (ESPP) and TES Evaluation Process, and a summary of the available information of potential environmental impacts resulting from glufosinate use on Pioneer 4114 Maize. 145DRAFT PIONEER 4114 MAIZE

6.2.2.1 EPA Endangered Species Protection Program (ESPP)
I n 1988, Congress enacted Public Law 100

- 478 (October 7, 1988) to in part address the relationship between ESA and US

- EPA ’s pesticide labeling program (S ection 1010), which required US

- EPA to conduct a study, and report to Congress, on ways to implement US

- EPA ’s endangered species pesticide labeling program in a manner that both complies with ESA and allows people to continue production of agricultural foo d and fiber. This law provided a clear sense that Congress wanted US

- EPA to fulfill its obligation to conserve listed species and at the same time consider the needs of agriculture and other pesticide users (70 FR 211 2005

- 11

- 02).
In 1988 US

- EPA establish ed the ESPP to meet its obligations under the ESA. US

- EPA ESPP Web site 30 describes the US

- EPA assessment process for endangered species. Some of the elements of that process, reported on the Web site, are summarized below. The goal of US

- EPA 's ESPP is to c arry out its responsibilities under the FIFRA in compliance with the ESA, without placing unnecessary burden on agriculture and other pesticide users consistent with Congress’ intent. US

- EPA is responsible for reviewing pesticide information and data to de termine whether a pesticide product may be registered for a particular use including those uses associated with the approval of biotechnology products. As part of that determination, the Agency assesses whether listed endangered or threatened species or th eir designated critical habitat may be affected by use of the pesticide product. All pesticide products that US

- EPA determines “may affect” a listed species or its designated critical habitat may be subject to the ESPP. If limitations on pesticide
use are necessary to protect listed species in areas where a pesticide may be used, the information is rela y ed through Endangered Species Protection Bulletins. Bulletins identify the species of concern and the pesticide active ingredient that may affect the listed species. They also provide a description of the protection measures necessary to protect the species, and contain a county

- level map showing the geographic area(s) associated with the protection measures, depending on the susceptibility of the species. Bu lletins are enforceable as part of the product label ( http://www.epa.gov/oppfead1/endanger/basic

- info.htm ; last accessed on August 23, 2012 and last updated by US

- EPA on May 9, 2012 ).

6.2.2.2 EPA TES Evaluation Process EPA evaluates listed species and their critical habitat concerns within the context of pesticide registration and registration review so that when a decision is made, it fully addresses issues relative to listed species protection. If a risk assessment determines that use limitations are necessary to ensure that legal use of a pesticide will not harm listed species or their critical habitat, US

- EPA may either change the terms of the pesticide registration or establish geographically

- specific pesticide use limitations ( http://www.epa.gov/oppfead1/endanger/basic

info.htm ). EPA’s review of the pesticide and its registration decision is independent of USDA

- APHIS ’ review and regulatory decisions under 7 CFR 340. US

- EPA does not require data or analyses

30 http:/ /www.epa.gov/espp/
146DRAFT PIONEER 4114 MAIZE

conducted by USDA

- APHIS to complete its reviews. US

- EPA evaluates extensive toxicity, ecological effects data, and environmental fate, transport and behavior data, most of w hich is required under FIFRA data requirements, to assess and determine how a pesticide will move through and break down in the environment. Risks to various taxa, e.g., birds, fish, invertebrates, plants and mammals are routinely assessed and used in US

- E PA ’s determinations of whether a pesticide may be licensed for use in the United States. EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in place for all populations of non

- target species, not just threatened and e ndangered species. US

EPA has developed a comprehensive risk assessment process modeled after, and consistent with, US

- EPA ’s numerous guidelines for EA s ( http://www.epa. gov/oppfead1/endanger/consultation/ecorisk

- overview.pdf ). The result of an assessment, which may go through several refinements, is to determine whether the potential effects of a pesticide’s registration to a listed species will result in either a “no eff ect” or “may affect” determination. US

- EPA consults on determinations that “may affect” a listed species or adversely modify its critical habitat ( http://www.epa.gov/oppfead1/endanger ). As a result of either an assessment or consultation, US

- EPA may require changes to the use conditions specified on the label of the product. When such changes are necessary only in specific geographic areas rather than nationwide to ensure protection of the listed species, US

- EPA implements these changes through geographically

- specific Endangered Species Protection Bulletins, otherwise, these changes are applied to the label for all uses of the pesticide.
6.2.2.3 Ecological Risks of Glufosinate
The US

- EPA first registered glufosina te ammonium in 2000 as a non

- selective foliar herbicide for use on a wide range of crops, including cotton ( US

- EPA, 2008b ; US

- EPA, 2008a ) . In 2008, the US

- EPA announced that it was undertaking a registration review of this product, and has published a final work plan for this process ( US

- EPA, 2008a )

. Assessments of the toxicity of glufosinate on Federally

- protected species conducted by US

- EPA indicated a relatively low risk to animals but high risk to plants ( US

- EPA, 2008b ) . On an acute exposure basis, glufosinate is considered practically nontoxic to birds, mammals, and insects; slightly toxic to freshwater fish, slightly tox ic to estuarine/marine fish; moderately toxic to freshwater and estuarine/marine invertebrates; and toxic to terrestrial and aquatic plants ( US

- EPA, 2008b )

. Non

- target exposure for plants typically results from runoff or drift. Although animals also can be affected from runoff and drift, ingestion is often the most important exposure pathway.
The US

- EPA ’s Final Work Plan for Registration Review for glufosinate ( US

- EPA, 2008a ) states that: The planned ecological risk asse ssment [ERA] will allow the Agency to determine whether glufosinate

- ammonium use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitat. If the assessment indicates that glufo sinate

- ammonium “may affect” a listed species or its designated critical habitat, the assessment will be refined. The refined assessment will allow the Agency to determine whether the use of glufosinate

- ammonium is “likely to adversely affect” the species or critical habitat or “not likely to adversely affect” the species or critical habitat. 147DRAFT PIONEER 4114 MAIZE

When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wi ldlife Service and National Marine Fisheries Service (the Services), as appropriate.

Submittals to this analysis can be found at www.Regulations.gov under docket designation EPA

- HQ

- OPP

- 2008

- 0190. In January 2013, the EPA made available the preliminary environmental fate and ecological risk assessment for the registration review of glufosinate, which can be found at www.Regulations.gov under docket designation EPA

- HQ

- OPP

- 2008

- 0190

- 0023 (US

- EPA, 2013 ). The preliminary conclusions for the potential direct affects to federally listed taxa associated with the registered uses of glufosinate indicated that there is the potential for direct effects from acute exposure to mammals and terrestrial and semi

- aq uatic plants, and chronic exposure to mammals as well as birds, reptiles, and amphibians. However, acute effects to mammals are not expected from applications at the maximum allowable labeled application rate for corn, and potential chronic effects are ex pected to birds, reptiles, and amphibians only at a rate equal to or exceeding 1.0 lb ai/A, with a minimum retreatment interval of 14 days. The maximum allowable labeled use on field corn is two applications at 0.4 ai/A with a minimum 14 day interval betw een applications. For seed production the rate may be increased to 0.52 ai/A, also with a minimum 14 day interval. A single burndown application is permitted at 0.66 ai/A. Therefore, the only potential direct effects to listed species from applications of glufosinate on corn are to mammals and plants. The threat to plants is from spray drift, and the assessment provides a possible effects distance for aerial application on corn at a rate of 0.44 ai/A to be 30 feet for monocots and 121 feet for dicots. (US

- EPA, 2013). EPA is currently developing a registration review decision which will propose ways to mitigate risk ( Weyrauch, 2013 )

. There are legal precautions in place to reduce the possibility of exposure and adverse impacts to TES from application of glufosinate to Pioneer 4114 Maize. These precautions include the US

EPA pesticide label restrictions and best practice guidance provided by the herbicide manufacturer ( see, e.g., Bayer, 2012 ) . Adherence to these label use restrictions by the pesticide applicator will ensure that the use of the herbicide will not adversely affect TES or critical habitat. Labe led uses of glufosinate are approved pending the outcome of the US

- EPA ’s ecological risk analysis. No changes to the US

- EPA approved label applications of glufosinate are proposed for cultivation of Pioneer 4114 Maize , but it is possible there may be label changes in the future for this and other corn varieties as a result of the registration review decision and possible consultation between EPA and USFWS/NMFS.

. EPA has imposed specific label use restrictions for glufosinate ammonium use when applied with a erial equipment including “The product should only be applied when the potential for drift to adjacent sensitive areas (e.g., residential areas, bodies of water, known habitat for TES , non
target crops) is minimal (e.g., when wind is blowing away from the sensitive areas)” ( Bayer, 2012 )

148DRAFT PIONEER 4114 MAIZE

To facilitate pesticide applic ators adherence to US

- EPA label use restrictions for glufosinate ammonium, the label for glufosinate provides specific instructions for managing spray drift and cautions pertaining to applications around water so as to minimize potential effects to non

- tar get organisms ( Bayer, 2012 ) . The label prohibits applications in conditions or locations where adverse impact on Federally listed endangered/threatened plants or aquatic species is likely ( Bayer, 2012 ) . Bayer also provides a technical and trade manual with additional guidance on the proper storage, handling and use of the product ( Bayer, 2012 )

. These US

- EPA label use restrictions and “best practice” guidan ce reduce the possibility of exposure and adverse impacts to TES from glufosinate application to Pioneer 4114 Maize varieties. US

- EPA has considered potential impacts to TES as part of their registration and labeling process for glufosinate; and adherence to US

- EPA label use restrictions by the pesticide applicator will ensure that the use of glufosinate will not adversely affect TES or critical habitat. As discussed previously, 1507 and 59122 Maize varieties also are resistant to glufosinate. These varieti es, and the commercial hybrid 1507 x 59122, have been cultivated commercially for many years, with approximately 16% of the corn acreage in 2011 cultivated in these varieties ( Pioneer, 2012 )

. USDA

- APHIS assumes that some of the growers cultivating these varieties may have included the application of glufosinate to these acres. The US

- EPA has not reported any impacts to TES from such use of glufosinate.
Pioneer has announce d its intention to market Pioneer 4114 Maize in other stacked or pyramided varieties by combining this trait via conventional hybridization techniques with other nonregulated varieties ( Pioneer, 2011b ) . The stacked variety discussed in the cumulative impacts analysis will combine the Pioneer 4114 Maize variety with a glyphosate

- resistant variety, providing the grower with the option to combine several herbicides with differe nt modes of action for control of weeds. The implications of the use of glyphosate on TES has been addressed in numerous other USDA

- APHIS EAs for products containing traits resistant to this herbicide. A list of the glyphosate

- resistant products reviewed a nd granted nonregulated status by USDA

- APHIS can be found at http://www.aphis.usda.gov/biotechnology/not_reg.html . The label use restrictions and best practices in place for the use of gl yphosate are intended to reduce the possibility of exposure of TES to this herbicide.

149DRAFT PIONEER 4114 MAIZE



### 7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACTS

7.1 EXECUTIVE ORDERS WITH DOMESTIC IMPLICATIONS The following two EO s require consideration of the potential impacts of the Federal action to minority and low income populations and children:

• EO 12898 ( US

- NARA, 2010 ) , "Federal Ac tions to Address Environmental Justice in Minority Populations and Low

- Income Populations," requires Federal agencies to conduct their programs, policies, and activities that substantially affect human health or the environment in a manner so as not to exc lude persons and populations from participation in or benefiting from such programs. It also enforces existing statutes to prevent minority and low

- income communities from being subjected to disproportionately high and adverse human health or environmental effects.

• EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” acknowledges that children may suffer disproportionately from environmental health and safety risks because of their developmental stage, greater metabolic acti vity levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by law and consistent with the agency’s mission) requires each Federal agency to identify, assess, and address environmental health risks and safety risks that may d isproportionately affect children. The No Action and Preferred Alternatives were analyzed with respect to EO 12898 and EO 13045. Neither alternative is expected to have a disproportionate adverse effect on minorities, low

- income populations, or children. Available mammalian toxicity data associated with the Cry and PAT proteins establishes the safety of Pioneer 4114 Maize and its products to humans, including minorities, low income populations, and children who might be exposed to them through agricultural production and/or processing. No additional safety precautions would need to be taken. Human toxicity also has been evaluated thoroughly by the US

- EPA in its development of pesticide labels for glufosinate ( Bayer, 2012 ) . Pesticide labels include use precautions and restrictions intended to protect workers and their families from exposures. It is reasonable to assume that growers will adhere to these US

- EPA herbicide use precautions and restrictions. As discussed in Subsection 4.5

– Public Health, the potential use of glufosinate on Pioneer 4114 Maize at the proposed application rates would be no more than rates currently approved by the US

- EPA and should not to have adverse impacts to human health when used in accordance with label instructions. It is expected that US

- EPA would monitor the use of Pioneer 4114 Maize to determine impacts on agricultural practices, such as chemical use, as they have done previously for herbicide

- resistant products.
As discussed in Subsection 4.2

– Agricultural Production of Corn the cultivation of GE corn varieties with herbicide

- resistant traits no longer subject to the regulatory requirements of 7 CFR 150DRAFT PIONEER 4114 MAIZE

Part 340 or the plant pest provisions of the Plant Protection Act of 2000 has been associated with a decrease and/or shift in pesticide applications for those who adopt these variet ies that is either favorable or neutral with respect to environmental and human toxicity. The determination of nonregulated status of this variety provides growers with alternative herbicide options with different modes of action. As discussed in Subsectio ns 2.1

– Corn Background Information and 4.2

– Agricultural Production of Corn , the herbicide glufosinate is already labeled for use in corn. However, capture of a certain market segment by a GE crop does not automatically result in a corresponding applica tion of the agronomic inputs associated with the GE event. This is specifically evidenced in the case of the glufosinate

- resistant corn. Market segment data would suggest that glufosinate ammonium is already widely used in corn; in 2010, approximately 16% of the total corn acreage in the United States was planted with corn varieties resistant to glufosinate. However, the use of glufosinate on total corn acres has remained stable and low over the past decade (2 %

- 6% of the total U.S. corn acres) ( GfK Kynetec, 2010 ; Pioneer, 2011b ; Pioneer, 2012 )

. The US

- EPA also has considered human health in its review of the Cry proteins under the PIP s analysis under FIFRA (see US

- EPA, 1998 ; US

- EPA, 2010b ; US

- EPA, 2010a ) and the determination of exemptions from tolerance for the PAT protein and the Cry proteins under FFDCA ( see US

- EPA, 2007a )

. Based on these factors, the determinatio n of nonregulated status of Pioneer 4114 Maize is not expected to have a disproportionate adverse effect on minorities, low income populations, or children. The following EO addresses Federal responsibilities regarding the introduction and effects of inva sive species:

• EO 1311 ( US

- NARA, 2010 ) , “Invasive Species,” states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to minimize the economic, ecological, and human health impacts that invasive species
cause. Corn is not listed in the United States as a noxious weed species by the Federal government, nor is it listed as an invasive specie s by major invasive plant databases. Corn does not possess characteristics such as resistance for a variety of habitat conditions, rapid growth and reproduction, aggressive competition for resources, and the lack of natural enemies or pests. Non

- engineered corn, as well as other herbicide

- resistant corn varieties, is widely grown in the United States. Based on historical experience with these varieties and the data submitted by the applicant and reviewed by USDA

- APHIS , Pioneer 4114 Maize plants are sufficie ntly similar in fitness characteristics to other corn varieties grown currently and are not expected to become weedy or invasive ( USDA

- APHIS, 2012e )

. The following EO requires the protection of migratory bird populations:

• EO 13186 ( US

- NARA, 2010 ) , “Responsibilities of Federal Agencies to Protect Migratory Birds,” states that Federal agencies taking actions that have, or are likel y to 151DRAFT PIONEER 4114 MAIZE

have, a measurable negative effect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understanding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird popu lations. Data submitted by the applicant has shown no substantial difference in compositional and nutritional quality of Pioneer 4114 Maize compared with other GE corn or non

- GE corn, apart from the presence of the Cry and PAT proteins . As previously disc ussed, the protein constituents expressed in Pioneer 4114 Maize have been cultivated in a wide variety of commercial corn strains since 1995. The migratory birds that forage in cornfields are unlikely to be affected adversely by ingesting Pioneer 4114 Maiz e and its products.
The US

- EPA has considered toxicity of glufosinate to birds in its registration review ( US

- EPA, 2008a )

. Acute and chronic risk quotients for birds were determined to slightly exceed the levels of concern; however, this finding wa s based on the highest tested dose ( US

- EPA, 2008a )

. In tests of acute and chronic exposure, the US

- EPA found that glufosinate was practically non

- toxic to birds ( US

- EPA, 2008a )

. Based on these factors, it is unlikely that the determination o f nonregulated status of Pioneer 4114 Maize will have a negative effect on migratory bird populations.
7.2 INTERNATIONAL IMPLICATIONS
EO 12114 ( U S

- NARA, 2010 ) , “Environmental Effects Abroad of Major Federal Actions” requires Federal officials to take into consideration any potential environmental effects outside the United States, its territories, and possessions that result from actions being t aken.
USDA

- APHIS has given this EO due consideration and does not expect a substantial environmental impact outside the United States in the event of a determination of nonregulated status of Pioneer 4114 Maize. It should be noted that all the existing na tional and international regulatory authorities and phytosanitary regimes that currently apply to introductions of new corn cultivars internationally apply equally to those covered by an USDA

- APHIS determination of nonregulated status under Part 340. Any international trade of Pioneer 4114 Maize and its products subsequent to a determination of nonregulated status for the product would be fully subject to national phytosanitary requirements and be in accordance with phytosanitary standards developed under the International Plant Protection Convention ( IPPC, 2010 ) . The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control” ( IPPC, 2010 ) . The protection it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds. The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification among the nations that have signed or acceded to the Convention (172 countries as of March 2010). In April 2004, a standard for Pest Risk Analysis ( PRA ) of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a sup plement to an
152DRAFT PIONEER 4114 MAIZE

existing standard, International Standard for Phytosanitary Measure No. 11 (ISPM

- 11, Pest Risk Analysis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a determination needs to be made earl y in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. USDA

- APHIS pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed under the IPP C. 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 P rotocol on Biosafety is a treaty under the United Nations Convention on Biological Diversity (CBD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity, of LMOs, which include those modified thr ough biotechnology. The Protocol came into force on September 11, 2003, and 160 countries are Parties to it as of December 2010 ( CBD, 2010 ) . Although the United States is not a party to the CBD, and thus not a party to the Cartagena Protocol on Biosafety, United States exporters will still need to comply with those regulations that importing countries which are Parties to the Protocol have promulgated to comply with their obligations. The first intentional transboundary movement of LMOs intended for environmental release (field trials or commercial planting) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessmen t 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 LMO s for FFP that may be subject to transboundary movement. To facilitate compliance with obligations to this protocol, the United States Government has developed a website that provides the status of all regulatory reviews completed for different uses of bio engineered products ( NBII, 2010 )

. USDA

- APHIS continues to work toward harmonization of biosafety and biotechnology consensus documents, guidelines, and regulations, including withi n the North American Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the United States, and within the Organization for Economic Cooperation and Development (OECD). NAPPO has completed three modules of the Regional Standards for P hytosanitary Measures (RSPM) No. 14, Importation and Release into the Environment of Transgenic Plants in NAPPO Member Countries ( NAPPO, 2003 )

. USDA

- APHIS also participates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperation on agricultural bio technology issues for the United States, Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held regularly with other countries including Argentina, Brazil, Japan, China, and Korea. Pioneer has stated that regulat ory submissions will be made in key United States maize export markets, including Canada, Japan, Mexico, Taiwan, South Korea and China ( Pioneer, 2011b )

. Pioneer further not es that full commercial launch of an y maize products containing Pioneer 4114 153DRAFT PIONEER 4114 MAIZE

Maize will occur only after obtaining all necessary authorizations in the United States and key import countries with functioning regulatory processes ( Pioneer, 2012 )

. 7.3 COMPLIANCE WITH CLEAN WATER ACT AND CLEAN AIR ACT This EA evaluated the potential changes in corn production due to a determination of nonregulated status of Pioneer 4114 Maize. Cul tivation of Pioneer 4114 Maize is not expected to lead to the increased production of corn in U.S. agriculture. There is no expected change in water use and quality due to the cultivation of Pioneer 4114 Maize compared with current corn production. Also, there is no expected change in air quality associated with the cultivation of Pioneer 4114 Maize. Based on this review, USDA

- APHIS concludes that the cultivation of Pioneer 4114 Maize would comply with the Clean Water Act and the Clean Air Act.
7.4 IMPACTS ON UNIQUE CHARACTERISTICS OF GEOGRAPHIC AREAS

A determination of nonregulated status of Pioneer 4114 Maize is not expected to impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologic ally critical areas. Pioneer has presented results of agronomic field trials for Pioneer 4114 Maize. The results of these field trials demonstrate that there are no differences in agronomic practices between Pioneer 4114 Maize and non

- GE hybrids. The commo n agricultural practices that would be carried out in the cultivation of Pioneer 4114 Maize are not expected to deviate from current practices, nor will the use of US

- EPA registered pesticides. The product is expected to be deployed on agricultural land cu rrently suitable for production of corn and replace existing varieties, and is not expected to increase the acreage of corn production. There are no proposed major ground disturbances; no new physical destruction or damage to property; no alterations of p roperty, wildlife habitat, or landscapes; and no prescribed sale, lease, or transfer of ownership of any property. This action is limited to a determination of nonregulated status of Pioneer 4114 Maize. This action would not convert land use to non

agricul tural use and therefore would have no adverse impact on prime farm land. Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on agricultural lands planted to Pioneer 4114 Maize, including the u se of US

- EPA registered pesticides. The Applicant’s adherence to US

- EPA label use restrictions for all pesticides is expected to mitigate potential impacts to the human environment. With regard to pesticide use, a determination of nonregulated status of Pioneer 4114 Maize is not likely to result in changes to the use of glufosinate on corn. USDA

- APHIS assumes that growers who elect to cultivate commercial varieties based on the Pioneer 4114 Maize will adhere closely to US

- EPA label use restrictions for al l pesticides applied to their crop. All pesticides distributed or sold in the United States are subject to registration by the US

- EPA under authority of FIFRA. Glufosinate ammonium was first registered for use by the US

- EPA in 154DRAFT PIONEER 4114 MAIZE

2000. Glufosinate is current ly undergoing registration review by the US

- EPA

. The US

- EPA has published documents relevant to its glufosinate registration review decision, including a Summary Document, a Preliminary Work Plan, and a Final Work Plan Registration Review. (See the docket folder for US

- EPA

- HQ

- OPP

- 2008

- 0190 at the Regulations.gov website.) The US

EPA has completed preliminary human health and ecological effects analyses and has identified risk assessment data needs ( US

- EPA, 2008a )

. When these data are received, US

- EPA intends to conduct an ecological and endangered species risk assessment and revisions to the human health dietary, residential, occupational, and aggregate risk assessments ( US

- EPA, 2008a )

. US

- EPA produced an estimated timeline for the completion o f the final registration review, with a final decision due in late 2013. Based on these findings, including the assumption that US

- EPA label use restrictions are in place to protect unique geographic areas and that those label use restrictions are adhered to, a determination of nonregulated status of Pioneer 4114 Maize is not expected to impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas.
7.5 NATIONAL HISTORIC PRESERVATION ACT (NHPA) OF 1966 AS AMENDED The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that have the potential to cause effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate.
USDA

- APHIS ’ proposed action, a deter mination of nonregulated status of Pioneer 4114 Maize and products based on this variety, is not expected to adversely impact cultural resources on tribal properties. Any farming activity that may be taken by farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would have control over any potential conflict with cultural resources on tribal properties.
USDA

- APHIS ’ Preferred Alternative would have no impact on districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause any loss or destruction of scientific, cultural, or historical resources. This action is limited to a determination of nonregulated status of Pioneer 4114 Maize

. USDA

- APHIS ’ proposed action is not an undertaking that may directly or indirectly cause alteration in the character or use of historic properties protected under the NHPA. In general, common agricultural activities conducted under this action do not have t he potential to introduce visual, atmospheric, or noise elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is potential for audible effects on the use and enjoyment of a historic property when common agricultural practices, such as the operation of tractors and other mechanical equipment, are conducted close to such sites. A 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.
155DRAFT PIONEER 4114 MAIZE

Additionally, these cultivation practices are already being cond ucted throughout the corn production regions. The cultivation of Pioneer 4114 Maize is not expected to change any of these agronomic practices that would result in an adverse impact under the NHPA.

156DRAFT PIONEER 4114 MAIZE



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- 248). Adopted on 03 April 2009." The EFSA Journal. 1050 p 1

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- 59122

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- FDA (2006) "Guidance for Industry: Recommendations for the early Food Safety Evaluation of New Non

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register/executive

- orders/disposition.html >. One Hundred Tenth Congres s "Food, Conservation, and Energy Act of 2008." Second. H.R. 2419. 2008. http://www.govtrack.us/congress/bills/110/hr2419/text >. USCB (2011) "Table 213. Per Capita Consumption of Major food Commodities: 1980 to 2008." < http://www.census.gov/compendia/statab/2011/tables/11s0213.pdf >. USDA

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products/commodity

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Defined_Queries/2010_C orn_Upland_Cotton_Fall_Potatoes/index.asp >. USDA

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Defined_Queries/2 010_Corn_Upland_Cotton_Fall_Potatoes/index.asp >. USDA

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10

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- NRCS (2006b) "Conservation Resource Brief: Soil Erosion, Number 0602." National Resources Conservation Service< http://www.nrcs.usda.gov/Internet/FSE_DOCUMENTS/nrcs143_023234.pdf >. USDA

- NRCS (2006c) "Conservation Resource Brief: Soil Quality, Number 0601." National Resources Conservation Service< http://www.nrcs.usda.gov/Internet/FSE_DOCUMENTS/nrcs143_023219.pdf >. USDA

- NRCS (2010) "2007 National Resources Inventory: Soil Erosion on Cropland." National Resources Conservation Service. Last Accessed: November 9, 20 10 < http://www.nrcs.usda.gov/technical/nri/2007/2007_NRI_Soil_Erosion.pdf >. USDA

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- Zea mexicana (Schrad.) Kuntze, Mexican teosinte." USDA Natural Resources Conservation Service< http://plants.usda.gov/java/reference?symbol=ZEME >.
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- N RCS (2012c) "PLANTS Profile

- Zea perennis (Hitchc.) Reeves & Manglesdorf, perennial teosinte." USDA, Natural Resources Conservation Service< http://plants.usda.gov/java/reference?symbol=ZEP E >. USDA

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- Office of the Chief Economist, Agricultural Marketing Service, Farm Service Agency, Economic Research Service, and Foreign Agricultural Service. USDA

- OCE (2012c) "World Agricultural Supply and Demand Estimates." USDA

- OCE (2012d) "World Agricultural Supply and Demand Estimates." USDA

- Office of the Chief Economist, Agricultural Marketing Service, Farm Service Agency, Economic Research Service, and Foreign Agricultural Service. USGC (2010) "Corn." U.S. Grains Council< http://www.grains.org/corn >. Van Deynze, A; Bradford, KJ; and Van Eenennaam, A. "Crop Biotechnology: Feeds for Livestock." Publication 8145 ed. Davis, CA: University of California, Seed Biotechnology Center, UC Davis, 2004. 6 of Agricultural Biotechnology In California Series

. Vencill, WK; Nichols, RL; Webster, TM; Soteres, JK; Mallory

- Smith, C; Burgos, NR; Johnson, WG; and McClelland, MR (2012) "Herbicide Resistance: Toward an Understanding of Resistance Develop ment and the Impact of Herbicide

- Resistant Crops." Weed Science. 60 (sp1): p 2

- 30. Vercauteren, KC and Hygnostrom, SE (1993) "White

- tailed deer home range characteristics and impacts relative to field corn damage." p 2. Lincoln, NE. http://digitalcommons.unl.edu/gpwdcwp/354 >. Vincelli, P and Parker, G. "Fumonisin, Vomitoxin, and Other Mycotoxins in Corn Produced by Fusarium Fungi." Ed. University of Kentucky, College of Agriculture, Cooperative Ext ension Service. Lexington, KY2002. Vol. ID

- 121. Vogel, JR; Majewski, MS; and Capel, PD (2008) "Pesticides in rain in four agricultural watersheds in the United States." Journal of Environmental Quality. 37 (3): p 1101

- 15. http://www.ncbi.nlm.nih.gov/pubmed/18453431 >. Walker, TS; Bais, HP; Grotewold, E; and Vivanco, JM (2003) "Root exudation and rhizosphere biology." Plant physiology. 132 (1): p 44

- 51. http://www.ncbi.nlm.nih.gov/pubmed/12746510 >. Weber, BM; Nuttelman, BL; Griffin, WA; Benton, JR; Erickson, G; and Klopfenstein, T (2011) "Performance of Growing Cattle Fed Corn Silage or Grazing Corn Residue from Second Generation Insect

- Pro tected (MON 89034), Parental, or Reference Corn Hybrids." University of Nebraska. Weirich, JW; Shaw, DR; Owen, MD; Dixon, PM; Weller, SC; Young, BG; Wilson, RG; and Jordan, DL (2011) "Benchmark study on glyphosate

- resistant cropping systems in the United States. Part 5: Effects of glyphosate

- based weed management programs on farm

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level profitability." Pest Management Science. 67 (7): p 781

- 4. http://www.ncbi.nlm.nih.gov/pubmed/21538796 >. Werblow, S (2007) "More Corn: Is Conservation Tillage at Risk?" Partners (Conservation Technology Information Center)< http://partnersarchive.ctic.org/partners/040107/feature.asp >. West, TO. "Net Carbon Sequestration in Agricultural: A National Assessment." N.D. 6. Weyrauch, K to: Vongpaseuth, Kham. (2013). EPA. Wibawa, W; Mohamad, RB; Omar, D; Zain, NM; Puteh, AB; and Awang, Y (2010) "Comparative impact of a single application of selected broad spectrum herbicides on ecological components of oil palm plantation." African Journal of Agricultural Research 5(16): p 2097

- 102. Wilkinson, KM and Elevitch, CR (2011) "The Overstory #65: Biological Nitrogen Fixation." < http://www.agroforestry.net/overstory/overstory65.html >. Wilson, EO (1988) Biodiversity . Ed. Peter, F.M. Washington, DC: National Academy Press. Wilson, J (2011) "Rising Corn Acreage Seen Failing to Meet Increased U.S. Feed, Ethanol Use." Bloomberg< http://www.bloomberg.com/news/2011

- 03

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- use.html >. Wilson, R; Sandell, L; Klein, R; and Bernards, M (2010) "Volunteer Corn Control." p 4. Last Accessed: June 29, 2011 < http://cpc.unl.edu/includes2010/pdf/VolunteerCornControl.pdf?exampleUserLabel=Yo ur%20Name&exampleSessionId=1229904000864 >. Wilson, RG; Young, BG; Matthews, JL; Weller, SC; Johnson, WG; Jordan, DL; Owen, MD; Dixon, PM; and Shaw, DR (2011) "Benchmark study on glyphosate

- resistant cropping systems in the United States. Part 4: Weed management practices and effects on weed populations and soil seedbanks." Pest Management Science. 67 (7): p 771

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Yoshida, S; Maruyama, S; Nozaki, H; and Shirasu, K (2010) "Horizontal gene transfer by the parasitic plant Striga hermonthica ." Science. 28 (5982). Young, IM and Ritz, K (2000) "Tillage, habitat space and function of soil microbes." Soil & Tillage Research. 53 p 201

- 12.

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APPENDIX A

– FEDERAL REGISTER NOTICE REGARDING PUBLIC INPUT IN DEREGULATION PROCESS

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APPENDIX B

– BAYER LIBERTY ® LABEL

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APPENDIX C

– APHIS THREATENED AND ENDANGERED SPECIES DECISION TREE FOR US

- FWS CONSULTATIONS
DECISION TREE ON WHETHER SECTION 7 CONSULTATION WITH FWS IS TRIGGERED FOR PETITIONS OF TRANSGENIC PLANTS This decision tree document is based on the phenotypes (traits) that have been permitted for environmental releases under APHIS oversight (for a list of approved notifications and environmental releases, visit I nformation Systems for Biotechnology, at http://isb.vt.edu .) APHIS will re

- evaluate and update this decision document as it receives new applications for environmental releases of new traits that are genetically engineered into plants.
BACKGROUND For each transgene(s)/transgenic plant the following information, data, and questions will be addressed by APHIS, and the EAs on each petition will be publicly available. APHIS review will encompass:

• A review of the biology, taxonomy, and weediness potential of the crop plant and its sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the plant and their quantity;

• A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;

• Determinatio n 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 199 2 on foods derived from new plant varieties, including those derived from transgenic plants ( http://vm.cfsan.fda.gov/~lrd/fr92529b.htm l and http://vm.cfsan.fda.gov/~lrd/consulpr.html ). The FDA’s policy requires that genetically engineered foods meet the same rigorous safety standards as is required of all other foods. Many of the food crops currently being developed using biotechnology do not contain substances that are substantially different from those already consumed by human and thus do not require 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.html . APHIS considers the status and conclusion of the FDA consultations in its EAs. Below is a description of our review process to whether a consultation with U.S. Fish and Wildlife Service is necessary.

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If the answer to any of the questions 1

- 4 below is yes, APHIS will contact FWS to determine if a consultation is required: Is the transgenic plant sexually compatible with a TE plant 31 without human intervention?
1. Are naturally occurring plant toxins (toxicants) or allelochemicals increased over the normal concentration range in parental plant species?
2. Does the transgene product or its metabolites have any significant similar ities to known toxins 32 ?
3. Will the new phenotype(s) imparted to the transgenic plant allow the plant to be grown or employed in new habitats (e.g., outside agro

- ecosystem) 33

. 4. Does the pest resistance 34 gene act by one of the mechanisms listed below? If the answer is YES then a consultation with U.S. Fish and Wildlife Service is NOT necessary. A. The transgene acts only in one or more of the following ways:
i. As a structural barrier to either the attachmen t of the pest to the host, to penetration of the host by the pest, to the spread of the pest in the host plant (e.g., the production of lignin, callose, thickened cuticles); ii. In the plant by inactivating or resisting toxins or other disease causing substanc es produced by the pest; iii. By creating a deficiency in the host of a component required for growth of the pest (such as with fungi and bacteria); iv. By initiating, enhancing, or potentiating the endogenous host hypersensitive disease resistance response found i n the plant;
v. In an indirect manner that does not result in killing or interfering with normal growth, development, or behavior of the pest; B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such as with coat protein, replicase, and pathogen virulence genes). For the biotechnologist:

31 APHIS will provide FWS a draft EA that will address the impacts, if any, of gene movement to the TES plant

32 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases like PIR, Swi ss
- Prot and HIV amino acid data bases.

33 Such phenotypes might include tolerance to environmental stresses such as drought, salt, frost, aluminum or heavy metals.

34 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels o r mitigates a pest or effects any vertebrate or invertebrate animal, plant, or microorganism.
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Depending on the outcome of the decision tree, initial the appropriate decision below and incorporate its language into the EA. Retain a hard copy of this decision document in the petition’ s file. ________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS has reached a determination that the release following a determination of nonregulated status would have no effects on listed threatened or endangered species and consequently, a written concurrence or formal consultation with the Fish and Wildlife Service is not requi red 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 reac hed 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.
________ B RS 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 th e release following a determination of non

- regulated status is likely to affect adversely one or more listed threatened or endangered species and has initiated a formal consultation with the Fish and Wildlife Service.

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