Monsanto Company Petition (07-CR-191U) for
Determination of Non-regulated Status of Event MON
87460
OECD Unique Identifier:
MON 87460-4
Draft Environmental Assessment
March 2011
Agency Contact
Cindy Eck
Biotechnology Regulatory Services
USDA, APHIS
4700 River Road
Riverdale, MD 20737
Fax: (301) 734-8669
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TDD). USDA is an equal opportunity provider and employer.
Mention of companies or commercial products in this report does not imply recommendation or
endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees
nor warrants the standard of any product mentioned. Product names are mentioned solely to report
factually on available data and to provide specific information.
This publication reports research involving pesticides. All uses of pesticides must be registered by
appropriate State and/or Federal agencies before they can be recommended.
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Table of Contents
LIST OF TABLES ........................................................................................................................ VI
LIST OF FIGURES ..................................................................................................................... VII
ACRONYMS AND ABBREVIATIONS .................................................................................. VIII
1 PURPOSE AND NEED ............................................................................................................ 1
1.1 Regulatory Authority........................................................................................................ 1
1.2 Regulated Organisms ....................................................................................................... 2
1.3 Petition for Determination of Nonregulated Status: MON 87460 Drought Tolerant Corn
......................................................................................................................................... 2
1.4 Purpose of Product ........................................................................................................... 3
1.5 APHIS Response to Petition for Nonregulated Status ..................................................... 3
1.6 Coordinated Framework Review ..................................................................................... 3
1.7 Public Involvement .......................................................................................................... 4
1.8 Issues Considered ............................................................................................................. 4
2 AFFECTED ENVIRONMENT ................................................................................................ 6
2.1 Agricultural Production of Corn ...................................................................................... 6
2.1.1 Current and Projected Acreage ............................................................................. ..6
2.1.2 Agronomic Practices ............................................................................................. ..7
2.1.2.1 Conventional and GE Corn Production Systems .............................................................. 7
2.1.2.2 Specialty Corn Production Systems ................................................................................ 10
2.1.2.3 Organic Corn Production Systems .................................................................................. 10
2.2 Physical Environment .................................................................................................... 12
2.2.1 Water Resources ................................................................................................... 12
2.2.2 Soil ........................................................................................................................ 12
2.2.3 Air Quality ............................................................................................................ 13
2.2.4 Climate Change ..................................................................................................... 13
2.3 Animals and Plant Communities and Biodiversity ........................................................ 14
2.3.1 Animal Communities ............................................................................................ 14
2.3.2 Plant Communities ................................................................................................ 15
2.3.3 Biodiversity ........................................................................................................... 16
2.3.4 Gene Flow ............................................................................................................. 16
2.3.4.1 Intraspecies gene flow ..................................................................................................... 17
2.4 Human Health ................................................................................................................ 19
2.4.1 Public Health ......................................................................................................... 19
2.4.2 Worker Safety ....................................................................................................... 19
2.5 Livestock Health ............................................................................................................ 20
2.6 Socioeconomic ............................................................................................................... 20
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2.6.1 Domestic and Trade Economic Environment ....................................................... 20
3 ALTERNATIVES................................................................................................................... 24
3.1 No Action Alternative: Continuation as a Regulated Article ........................................ 24
3.2 Preferred Alternative: Determination that MON 87460 CORN Is No Longer a
Regulated Article, In Whole .......................................................................................... 24
3.3 Alternatives Considered But Rejected from Further Consideration .............................. 25
3.3.1 Prohibit Any MON 87460 from Being Released .................................................. 25
3.3.2 Deregulation in Part: Isolation Distance between MON 87460 and Non-GE Corn
Production ............................................................................................................. 25
3.3.3 Deregulation in Part: Geographic Restrictions
............................................................................................................................... Er
ror! Bookmark not defined.
3.3.4 Requirement of Testing for MON 87460 .............................................................. 26
3.4 Comparison of Alternatives ........................................................................................... 27
4 ENVIRONMENTAL CONSEQUENCES ............................................................................. 29
4.1 Scope of Environmental Analysis .................................................................................. 29
4.2 Other Assumptions ......................................................................................................... 29
4.3 Agricultural Production of Corn .................................................................................... 30
4.3.1 Current Acreage and U.S. Cultivation Range ....................................................... 30
4.3.1.1 No Action Alternative: Current Acreage and U.S. Cultivation Range ........................... 30
4.3.1.2 Preferred Alternative: Current Acreage and U.S. Cultivation Range ............................. 31
4.3.1.3 Cumulative Effects: Current Acreage and U.S. Cultivation Range ................................ 34
4.3.2 Cropping Practices ................................................................................................ 34
4.3.2.1 No Action Alternative: Cropping Practices ....................................................................... 35
4.3.2.2 Preferred Alternative: Cropping Practices ......................................................................... 35
4.3.2.3 Cumulative Effects: Cropping Practices ............................................................................ 37
4.3.3 Organic .................................................................................................................. 37
4.3.3.1 No Action Alternative: Organic ...................................................................................... 38
4.3.3.2 Preferred Alternative: Organic ........................................................................................ 38
4.3.3.3 Cumulative Effects: Organic ........................................................................................... 40
4.4 Physical Environment .................................................................................................... 41
4.4.1 Water Usage and Water Quality ........................................................................... 41
4.4.1.1 No Action Alternative: Water Usage and Water Quality ................................................ 41
4.4.1.2 Preferred Alternative: Water Usage and Water Quality .................................................. 41
4.4.1.3 Cumulative Effects: Water Usage and Water Quality .................................................... 42
4.4.2 Soil ........................................................................................................................ 42
4.4.2.1 No Action Alternative: Soil ............................................................................................ 42
4.4.2.2 Preferred Alternative: Soil .............................................................................................. 43
4.4.2.3 Cumulative Effects: Soil ................................................................................................. 43
4.4.3 Air Quality ............................................................................................................ 43
4.4.3.1 No Action Alternative: Air Quality ................................................................................. 43
4.4.3.2
Preferred Alternative: Air Quality
................................................................................ 44
4.4.3.3 Cumulative Effects: Air Quality ..................................................................................... 44
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4.4.4 Climate Change ..................................................................................................... 44
4.4.4.1 No Action Alternative: Climate Change ......................................................................... 44
4.4.4.2 Preferred Alternative: Climate Change ........................................................................... 45
4.4.4.3 Cumulative Effects: Climate Change .............................................................................. 45
4.5 Animal and Plant Communities ..................................................................................... 45
4.5.1 Animal Communities ............................................................................................ 45
4.5.1.1 No Action Alternative: Animal Communities ................................................................ 45
4.5.1.2 Preferred Alternative: Animal Communities .................................................................. 45
4.5.2 Plant Communities ................................................................................................ 47
4.5.2.1 No Action Alternative: Plant Communities .................................................................... 47
4.5.2.2 Preferred Alternative: Plant Communities ...................................................................... 48
4.5.3 Biodiversity ........................................................................................................... 49
4.5.3.1 No Action Alternative: Biodiversity ............................................................................... 50
4.5.3.2 Preferred Alternative: Biodiversity ................................................................................. 50
4.5.3.3 Cumulative Effects: Animal and Plant Communities and Biodiversity ......................... 51
4.5.4 Gene Flow ............................................................................................................. 52
4.5.4.1 No Action Alternative: Gene Flow ................................................................................. 52
4.5.4.2 Preferred Alternative: Gene Flow ................................................................................... 52
4.5.4.3. Cumulative Effects: Gene Flow ........................................................................................ 53
4.6 Human Health ................................................................................................................ 53
4.6.1 Public Health ......................................................................................................... 53
4.6.1.1 No Action: Public Health ................................................................................................ 54
4.6.1.2 Preferred Alternative: Public Health ............................................................................... 54
4.6.1.3 Cumulative Effects: Public Health .................................................................................. 55
4.6.2 Worker Safety ....................................................................................................... 55
4.6.2.1 No Action: Worker Safety .............................................................................................. 56
4.6.2.2 Preferred Alternative: Worker Safety ............................................................................. 56
4.6.2.3 Cumulative Effects: Worker Safety ................................................................................ 56
4.7 Livestock Feed ............................................................................................................... 56
4.7.1 No Action: Livestock Feed ................................................................................... 56
4.7.2 Preferred Alternative: Livestock Feed .................................................................. 56
4.7.3 Cumulative Effects: Livestock Feed ..................................................................... 57
4.8 Socioeconomics .............................................................................................................. 57
4.8.1 Domestic Economic Environment ........................................................................ 57
4.8.1.1 No Action: Domestic Economic Environment ............................................................... 60
4.8.1.2
Preferred Alternative
: Domestic Economic Environment ............................................. 60
4.8.1.3 Cumulative Effects: Domestic Economic Environment ................................................. 63
4.8.2 Trade Economic Environment .............................................................................. 64
4.8.2.1 No Action: Trade Economic Environment ..................................................................... 65
4.8.2.2 Preferred Alternative: Trade Economic Environment .................................................... 65
4.8.2.3 Cumulative Effects: Trade Economic Environment ....................................................... 65
4.9 International Impacts Analysis ....................................................................................... 66
4.9.1 Transboundary Impacts ......................................................................................... 66
5 THREATENED AND ENDANGERED SPECIES ................................................................ 67
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6
CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES
RELATING TO
ENVIRONMENTAL IMPACTS
................................................................ 71
6.1.1
Executive Orders with Domestic Implications ..................................................... 71
6.1.2 International Implications ..................................................................................... 76
6.1.3 Compliance with Clean Water Act and Clean Air Act ......................................... 77
6.1.4 Impacts on Unique Characteristics of Geographic Areas ..................................... 77
6.1.5 National Historic Preservation Act (NHPA) of 1966 as Amended ...................... 78
7 REFERENCES ....................................................................................................................... 79
8 LIST OF PREPARERS........................................................................................................... 88
APPENDIX A. FDA BIOTECHNOLOGY CONSULTATION NOTE TO THE FILE (BNF NO.
000116) ................................................................................................................................... 91
Biotechnology Consultation - Note to the File Biotechnology Notification File BNF No.
000119 ........................................................................................................................... 91
APPENDIX B. POLLEN- AND GENE-MEDIATED GENE FLOW ........................................ 97
B.1. Gene Flow among Corn Cultivars .................................................................................. 97
B.1.1 Pollen-mediated Gene Flow .................................................................................. 97
B.1.2 Seed-mediated Gene Flow .................................................................................... 100
APPENDIX C. CHARACTERISTICS MEASURED FOR PHENOTYPIC, AGRONOMIC,
AND ENVIRONMENTAL INTERACTIONS ASSESSMENT OF MON 87460 .............. 102
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List of Tables
Table 1: Adoption of genetically engineered corn varieties by major U.S. corn production states,
2000-2010 ........................................................................................................................ 8
Table 2: Certified organic corn acreage by state with more than 1,000 acres of certified land in
2007 and 2008. ............................................................................................................... 11
Table 3: Relative importance of farms and corn in local economies. .......................................... 21
Table 4: Summary of potential impacts and consequences of Alternatives. ............................... 27
Table 5: Acreage for major field crops and Conservation Reserve Program (CRP)
assumptions, long-term projections ............................................................................... 32
Table 6: Percentage of herbicide-tolerant, insect-resistant, stacked trait, and total GE
corn in select Great Plains states .................................................................................... 35
Table 7: Non-organic and organic corn production (harvested acres) in 2007 ....................... 38-39
Table 8: Minority populations in states where MON 87460 may be adopted, 2008 .............. 70-71
Table 9: Minority farmer populations in states where MON 87460 may be adopted, 2007 .................. 71
Table 10: Low income presence, 2008 ............................................................................................. 72
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List of Figures
Figure 1: Corn, plant acres: 2009 ................................................................................................... 6
Figure 2: Irrigated corn for grain, harvest acres: 2007 ................................................................ 21
Figure 3: Average values for U.S. corn harvest and average annual precipitation ...................... 31
Figure 4: Total, irrigated, and percent irrigated corn acreage in the western dryland
Great Plains. ................................................................................................................. 33
Figure 5: Herbicide application trends in U.S. corn production, 2000-2005. .............................. 36
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Acronyms and Abbreviations
AIA
Advanced informed agreement
AOSCA
American Organization of Seed Certifying Agencies
APHIS
Animal and Plant Health Inspection Service
BRS
Biotechnology Regulatory Services (within USDA–APHIS)
Bt
Bacillus thuringiensis protein
CAA
Clean Air Act
CBD
Convention on Biological Diversity
CEQ
Council on Environmental Quality
CFR
Code of Federal Regulations (United States)
CH
4
methane
CO
carbon monoxide
CO
2
carbon dioxide
CRP
Conservation Reserve Program
CSPB
cold shock protein B
cspB
cold shock protein B gene
DNA
deoxyribonucleic acid
DT
drought tolerant
EA
environmental assessment
EIS
environmental impact statement
EO
Executive Order
EPA
U.S. Environmental Protection Agency
ESA
Endangered Species Act of 1973
FDA
U.S. Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act
FFP
food, feed, or processing
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
FR
Federal Register
GDP
gross domestic product
GE
genetically engineered
GHG
greenhouse gas
GMO
genetically modified organism
ix
GRAS
generally recognized as safe
IP
Identity Preservation
IPCC
Intergovernmental Panel on Climate Change
ISPM
International Standard for Phytosanitary Measure
IPPC
International Plant Protection Convention
LMO
living modified organisms
MOE
margin of exposure
NO
2
nitrogen dioxide
N
2
O
nitrous oxide
NAAQS
National Ambient Air Quality Standards
NABI
North American Biotechnology Initiative
NAPPO
North American Plant Protection Organization
NEPA
National Environmental Policy Act of 1969 and subsequent amendments
NHPA
National Historic Preservation Act
NOEL
no observable effect level
NPTII
nptII
neomycin phosphotransferase II protein
neomycin phosphotransferase II protein gene
NRC
National Research Council
PPRA
Plant Pest Risk Assessment
PPA
Plant Protection Act
PRA
pest risk analysis
RNA
ribonucleic acid
TES
threatened and endangered species
TSCA
Toxic Substances Control Act
U.S.
United States
USDA
U.S. Department of Agriculture
USDA-ERS
U.S. Department of Agriculture-Economic Research Service
USDA-FAS
U.S. Department of Agriculture-Foreign Agricultural Service
USDA-NASS
U.S. Department of Agriculture-National Agricultural Statistics Service
USDA-NOP
U.S. Department of Agriculture-National Organic Program
USC
United States Code
WPS
Worker Protection Standard for Agricultural Pesticides
1
1 PURPOSE AND NEED
1.1 Regulatory Authority
"Protecting American agriculture" is the basic charge of the United States Department of
Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides
leadership in ensuring the health and care of plants and animals. The agency improves
agricultural productivity and competitiveness, and contributes to the national economy and the
public health. USDA asserts that all methods of agricultural production (conventional,
genetically engineered, and organic systems) can provide benefits to the environment,
consumers, and farm income.
Since 1986, the United States government has regulated genetically engineered (GE) organisms
pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of
Biotechnology (Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated
Framework, published by the Office of Science and Technology Policy, describes the
comprehensive federal regulatory policy for ensuring the safety of biotechnology research and
products and explains how federal agencies will use existing Federal statutes in a manner to
ensure public health and environmental safety while maintaining regulatory flexibility to avoid
impeding the growth of the biotechnology industry. The Coordinated Framework is based on
several important guiding principles: (1) agencies should define those transgenic organisms
subject to review to the extent permitted by their respective statutory authorities; (2) agencies are
required to focus on the characteristics and risks of the biotechnology product, not the process by
which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when
there is evidence of “unreasonable” risk.
The Coordinated Framework explains the regulatory roles and authorities for the three major
agencies involved in regulating GE organisms: USDA’s Animal and Plant Health Inspection
Service (APHIS), the Food and Drug Administration (FDA), and the Environmental Protection
Agency (EPA).
APHIS is responsible for regulating GE organisms and plants under the plant pest authorities in
the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not
pose a plant pest risk to the environment.
The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic
Act. The FDA is responsible for ensuring the safety and proper labeling of all plant-derived
foods and feeds, including those that are genetically engineered. To help developers of food and
feed derived from GE crops comply with their obligations under Federal food safety laws, FDA
encourages them to participate in a voluntary consultation process. All food and feed derived
from GE crops currently on the market in the United States have successfully completed this
consultation process. The FDA policy statement concerning regulation of products derived from
new plant varieties, including those genetically engineered, was published in the Federal Register
on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a
consultation process to ensure that human food and animal feed safety issues or other regulatory
issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food.
2
The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and certain biological control organisms under the Toxic Substances
Control Act (TSCA). The EPA is responsible for regulating the sale, distribution and use of
pesticides, including pesticides that are produced by an organism through techniques of modern
biotechnology.
1.2 Regulated Organisms
The APHIS Biotechnology Regulatory Service’s (BRS) mission is to protect America’s
agriculture and environment using a dynamic and science-based regulatory framework that
allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of
Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by
the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701–7772), regulate the
introduction (importation, interstate movement, or release into the environment) of certain GE
organisms and products. A GE organism is no longer subject to the plant pest provisions of the
Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS
determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated
article if the donor organism, recipient organism, vector, or vector agent used in engineering the
organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered
a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe
that the GE organism may be a plant pest or APHIS does not have information to determine if
the GE organism is unlikely to pose a plant pest risk.
A person may petition the agency that a particular regulated article is unlikely to pose a plant
pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant
Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide
information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine
whether the regulated article is unlikely to present a greater plant pest risk than the unmodified
organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340
or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely
to pose a plant pest risk.
1.3 Petition for Determination of Nonregulated Status: MON 87460 Drought Tolerant
Corn
The Monsanto Company of St. Louis, MO, submitted a petition to APHIS in 2010 for
determination of nonregulated status for Event MON 87460 drought tolerant (DT) corn
(hereafter referred to as MON 87460) (Reeves, 2010).
In the event of a determination of
nonregulated status, the nonregulated status for MON 87460 would include MON 87460, and
any progeny derived from crosses between MON 87460 and conventional corn and crosses of
MON 87460 with other biotechnology-derived corn that has been
deregulated pursuant to Part
340 and the Plant Protection Act
. Event MON 87460 is currently regulated under 7 CFR Part
340. Interstate movements and field trials of MON 87460 have been conducted under permits
issued or notifications acknowledged by APHIS since 2002. Data resulting from these field
trials are described in the Monsanto Company petition (Reeves, 2010).
3
1.4 Purpose of Product
MON 87460 is designed to mitigate grain yield loss under water-limited conditions. As detailed
in the Monsanto Company petition, the enhanced drought tolerance of MON 87460 results from
the introduction and controlled expression of cold shock protein B (cspB), a native ribonucleic
acid (RNA) chaperone derived from Bacillus subtilis (Reeves, 2010). The enhanced drought
tolerant phenotype of MON 87460 manifests primarily as reduced yield loss relative to
conventional corn when subjected to water-limiting conditions. When MON 87460 was
subjected to well-watered conditions, grain yield for MON 87460 was not notably different than
conventional corn. Data provided by the Monsanto Company demonstrates that MON 87460
reduces yield loss under water-limiting conditions primarily by minimizing the effect of water
deficiency on photosynthesis, stomatal conductance, and carbon fixation on corn growth and
development, resulting in an increased number of kernels per ear (Reeves, 2010).
Drought is one of the major limiting factors in corn that prevents realization of optimum grain
yield worldwide (Boyer, 1982; Bray et al., 2000). In North America alone, it is estimated that 40
percent of distributed crop loss insurance indemnities are due to sub-optimal water availability
(Boyer, 1982). In temperate zone areas of commercial corn production, average global annual
losses due to moderate drought are approximately 15 percent, though losses can be much higher
under conditions of severe drought (Barker et al., 2005).
1.5 APHIS Response to Petition for Nonregulated Status
Under the authority of the plant pest provisions of the Plant Protection Act and 7 CFR part 340,
APHIS has issued regulations for the safe development and use of GE organisms. As required
by 7 CFR 340.6, APHIS must respond to petitioners that request a determination of the regulated
status of genetically engineered organisms, including GE plants such as MON 87460 corn. When
a petition for nonregulated status is submitted, APHIS must make a determination if the
genetically engineered organism is unlikely to pose a plant pest risk. If APHIS determines based
on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organism is unlikely to
pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest
provisions of the Plant Protection Act and 7 CFR part 340.
APHIS has prepared this environmental assessment (EA) to consider the potential environmental
effects of an agency determination of nonregulated status consistent with NEPA regulations (40
CFR parts 1500-1508, 7 CFR part 1b, and 7 CFR part 372) and the USDA and APHIS NEPA
implementing regulations and procedures. This EA has been prepared in order to specifically
evaluate the effects on the quality of the human environment
1
that may result from the
deregulation of MON 87460 corn.
1.6 Coordinated Framework Review
MON 87460 does not contain a biotechnology-derived PIP nor is it a biological control
organism; thus, EPA does not regulate MON 87460.MON 87460 is within the scope of the FDA
1
Under NEPA regulations, the “human environment” includes “the natural and physical environment and the
relationship of people with that environment” (40 CFR §1508.14)
4
policy statement concerning regulation of products derived from new plant varieties, including
those produced through genetic engineering. The Monsanto Company initiated the consultation
process with FDA for the commercial distribution of MON 87460, and submitted a safety and
nutritional assessment of food and feed derived from MON 87460 to the FDA on December 19,
2008. Based on the information the Monsanto Company submitted, and as of December 2010
(BNF No. 000116), FDA has no further questions regarding MON 87460 drought tolerant corn
(FDA, 2010).
1.7 Public Involvement
APHIS routinely seeks public comment on draft environmental assessments prepared in response
to petitions to deregulate GE organisms. APHIS does this through a notice published in the
Federal Register. The issues discussed in this EA were developed by considering public concerns
as well as issues raised in public comments submitted for other environmental assessments of GE
organisms, concerns raised in lawsuits, as well as those issues that have been raised by various
stakeholders. These issues, including those regarding the agricultural production of corn using
various production methods, and the environmental and food/feed safety of GE plants were
addressed to analyze the potential environmental impacts of MON 87460.
This EA, the petition submitted by the Monsanto Company (Reeves, 2010), and APHIS’ Plant
Pest Risk Assessment (USDA-APHIS, 2010) will be available for public comment for a period
of 60 days (7 CFR § 340.6(d)(2)). Comments received by the end of the 60-day period will be
analyzed and used to inform APHIS’ determination decision of the regulated status of MON
87460 and to assist APHIS in determining whether an Environmental Impact Statement (EIS) is
required prior to the determination decision of the regulated status of these corn lines.
1.8 Issues Considered
The list of resource areas considered in this draft EA were developed by APHIS through
experience in considering public concerns and issues raised in public comments submitted for
other EAs of GE organisms. The resource areas considered also address concerns raised in
previous and unrelated lawsuits, as well as issues that have been raised by various stakeholders
in the past. The resource areas considered in this EA can be categorized as follows:
Management considerations:
Acreage and areas of corn production,
– Cropping practices,
– Specialty corn production.
Environmental considerations:
– Water use and quality,
– Soil,
– Climate change,
– Animals,
– Plants,
– Biological diversity, and
– Gene movement.
5
Human health considerations:
– Public health,
– Worker safety, and
– Livestock feed.
Socioeconomic considerations:
Domestic economic environment, and
Trade economic environment.
6
2 AFFECTED ENVIRONMENT
2.1 Agricultural Production of Corn
2.1.1 Current and Projected Acreage
Corn (Zea mays L.), a member of the Maydeae grass family tribe, is an annual plant cultivated
under a variety of production environments (Morris and Hill, 1998). In the U.S., corn is
generally cultivated in temperate regions that provide sufficient moisture and an adequate
number of frost-free days to reach maturity. U.S. corn production is primarily focused in the
Corn Belt, an area that represents approximately 80 percent of annual U.S. corn production and
includes Iowa, Illinois, Nebraska, and Minnesota, and parts of Indiana, South Dakota, Kansas,
Ohio, Wisconsin, and Missouri (USDA-NASS, 2010b). Figure 1 presents the planted acres of
corn in the U.S. in 2009 (USDA-NASS, 2010c). In general, the Corn Belt has an adequate
combination of seasonal warm weather, rainfall, and favorable soil conditions for growth. While
the Midwest, where approximately 65 percent of U.S. corn is produced, typically experiences a
minimum of 30 inches of rainfall annually, the central part of the Great Plains (~26 percent of
U.S. corn production) receives an average of 20 inches, making it less optimal for corn
production (Lew, 2004).
Figure 1. Corn, planted acres: 2009
Source: (USDA-NASS 2010c).
7
The U.S. is the world's largest producer and exporter of corn. From 2008 through 2010, the U.S.
produced approximately 40 percent of the world’s total corn harvest (FAOSTAT, 2008). During
the 2009/2010 market year, 86.4 million acres of corn were planted and approximately 13.1
billion bushels of corn were harvested in the U.S. (USDA-NASS, 2010b). In terms of domestic
use, animal feed/residuals and biofuel production utilized the majority of produced corn (39 and
35 percent, respectively), whereas lesser amounts were used for exportation to foreign markets
(15 percent), ending stock seed (13 percent), food and industrial purposes (10 percent), and seed
stock for hybrid seed production (0.17 percent) (USDA-NASS, 2010a).
Each year, the USDA-Economic Research Service (ERS) updates its ten-year projections of
supply and utilization for major field crops, including corn, soybeans, and wheat grown in the
U.S. At present, U.S. corn growers are on track to slightly increase planted corn acreage from
the current level of 88.2 million acres to 92 million acres by 2020 (USDA-ERS, 2011b). This
ten-year projection reflects an increased domestic and international demand for U.S. corn, and
will be driven by improvements in plant genetics, machinery, and cultivation practices (USDA-
ERS, 2010e). Arable land for increased corn planting acreage will result from grower shifts
away from soybean or wheat cultivation and from the return of Conservation Reserve Program
(CRP) lands to agricultural production (USDA-ERS, 2011b). Representing a reduction from
39.2 million acres to 32 million acres, this return of CRP land back into agricultural production
has been stipulated by the Food, Conservation, and Energy Act of 2008 to provide additional
cropland to meet future agricultural demands (Farm Bill, 2008).
2.1.2 Agronomic Practices
2.1.2.1 Conventional and GE Corn Production Systems
Conventional farming in this document includes any farming system where synthetic pesticides
or fertilizers may be used. Conventional farming covers a broad scope of farming practices,
ranging from farmers who only occasionally use synthetic pesticides and fertilizers to those
farmers whose harvest depends on regular pesticide and fertilizer inputs. This definition of
conventional farming also includes the use of genetically engineered (GE) varieties that have
been deregulated by APHIS.
Growers can choose from a large number of corn hybrids produced from traditional breeding or
genetic engineering systems (NCGA, 2010). Adoption of GE corn in the U.S. has significantly
increased since 2000 on both the state and national level, with 86 percent of all corn planted in
2010 representing a GE variety (Table 1). Additionally, growers can also choose from several
different crop management options. Though specific details of these management options differ
in terms of geographic cultivation area and end-use market, general management decisions are
commonly shared. These include method of tillage, addition of agronomic inputs, and selection
of crop rotation system.
8
Table 1: Adoption of genetically engineered corn varieties by major U.S. corn production
states, 2000-2010.
GE Corn Varieties
(percent of all corn planted)
State 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Illinois 17 16 22 28 33 36 55 74 80 84 82
Indiana 11 12 13 16 21 26 40 59 78 79 83
Iowa 30 32 41 45 54 60 64 78 84 86 90
Kansas 33 38 43 47 54 63 68 82 90 91 90
Michigan 12 17 22 35 33 40 44 60 72 75 80
Minnesota 37 36 44 53 63 66 73 86 88 88 92
Missouri 28 32 34 42 49 55 59 62 70 77 79
Nebraska 34 34 46 52 60 69 76 79 86 91 91
North Dakota - - - - - 75 83 88 89 93 93
Ohio 9 11 9 9 13 18 26 41 66 67 71
South Dakota 48 47 66 75 79 83 86 93 95 96 95
Texas - - - - - 72 77 79 78 84 85
Wisconsin 18 18 26 32 38 46 50 64 75 77 80
Other States 17 20 27 36 46 44 55 67 74 78 82
U.S. total 25 26 34 40 47 52 61 73 80 85 86
Source: (USDA-ERS, 2010a)
Prior to planting, the soil must be stripped of weeds that would otherwise compete with the crop
for space, water, and nutrients. Field preparation is accomplished through a variety of tillage
systems, with each system defined by the remaining plant residue on the field. Conventional
tillage is associated with intensive plowing and less than 15 percent crop residue; reduced tillage
is associated with 15 to 30 percent crop residue; and conservation tillage, including no-till
practices requiring herbicide application on the plant residue from the previous season, is
associated with at least 30 percent crop residue and substantially less soil erosion than other
tillage practices (EPA, 2009). Conservation tillage has been associated with higher soil moisture
retention when compared to conventional and reduced tillage methods (Smika and Wicks, 1968;
Tanaka and Aase, 1987). Because of its low cost and positive impact on soil quality,
conservation tillage is currently and widely practiced in the Midwestern U.S. (EPA, 2009).
Corn production typically involves the extensive use of agronomic inputs to maximize grain
yield (Olson and Sander, 1988). Agronomic inputs include corn fertilizers to supplement
available nutrients in the soil; pesticides to reduce pest plant, insect, and/or microbial
populations; and moisture to ensure normal plant growth and development (Cerrato and
Blackmer, 1990; M. R. Hall et al., 1992; Howell et al., 1998; Levine, 1991; Smith and White,
1988).
9
Given the importance of nutrient availability to corn agronomic performance, fertilization with
nitrogen, phosphorus, and potassium is widely practiced. In 2005 (the date of the last USDA
Agricultural Chemical Usage Summary to include corn) nitrogen was applied to 96 percent of
corn acreage at an average of 138 pounds per acre (lb/acre); phosphate was applied to 81 percent
of corn acreage at an average rate of 58 lb/acre; and potash was applied at a rate of 84 lb/acre to
65 percent of corn acreage (USDA-NASS, 2006). Like fertilizer application, pesticide use for
pest control is also common in corn. Herbicides were applied to 97 percent of corn acreage in
2005, with Atrazine (66 percent), Glyphosate (31 percent), S-metolachlor (23 percent) and
Acetochlor (23 percent) representing next the most widely-applied herbicide (USDA-NASS,
2006). Additionally, 23 percent of corn-planted acreage was treated with insecticides, with the
most abundantly applied being Tefluthrin (7 percent), Cyfluthrin (7 percent), and Tebupirimphos
(6 percent) (USDA-NASS, 2006). While agricultural herbicide use trends resulting from the
utilization of GE technologies are the subject of much debate (Benbrook, 2009; Brookes and
Barfoot, 2010; Fernandez-Cornejo et al., 2009), it is generally agreed that insecticide use in U.S.
crops has decreased since the introduction of GE insect-resistant crop varieties (Benbrook,
2009). In 2010, 63 percent of total U.S. corn acreage was planted with insect-resistant corn
(USDA-ERS, 2010a).
In major U.S. corn production regions, moisture availability is strongly correlated with grain
yield. For example, four consecutive days of visible wilting prior to tassel emergence can reduce
grain yields by 25 percent, while this same duration of stress during silk
emergence/anthesis/grain fill can cause a 40 to 50 percent yield reduction (Hesterman and Carter,
1990; McWilliams, 2002). Drought-related reduction in grain yield is mediated through several
mechanisms, including reduced grain number, an increase in floral asynchrony, and the abortion
of fertilized kernels during ear development (Westgate et al., 2004).
Corn generally requires a steady supply of moisture, though the amount required is dependent on
developmental stage. For example, prior to pollination, corn generally requires 0.1 inches per
day; during pollination and grain fill, this water requirement increases to a maximum of 0.35
inches per day (McWilliams, 2002). This moisture demand is met by a combination of natural
rainfall/stored soil moisture and supplemental irrigation during the growing season (Neild and
Newman, 1990). In U.S. corn production areas where supplemental irrigation is practiced, light
and frequent irrigation is superior to heavier, less frequent irrigation involving the same overall
amount of water (Olson and Sander, 1988). Under conditions of moderate water deficit, corn
yields can be reduced by approximately 15 percent; crop failure can also result under more
severe drought conditions (Barker, et al., 2005). While conventionally-produced corn hybrids
have been produced to exhibit increased drought tolerance, the basic water requirements of corn
have not been overcome. Thus, these drought-tolerant varieties will not likely be grown outside
of current corn cultivation areas.
Crop rotation is practiced to increase soil fertility and reduce the proliferation of pests and
diseases. For example, in a corn-soybean rotation, continuously growing corn for multiple
growing seasons can decrease populations of soybean pests, such as soybean cyst nematode
(Hoeft et al., 2000). Decisions about crop sequences are guided by many factors, including
economic return from differences in input cost, yield potential, and commodity prices. Crops
used in rotation with corn vary regionally, but there has been an increase in the number of fields
that have a corn-to-corn rotation, as opposed to rotation to another crop other than corn. The
10
increased adoption of corn-to-corn rotation, mainly in conventional and GE production systems,
has been attributed to rising corn demand and prices (Hart, 2006; Stockton et al., 2007).
2.1.2.2 Specialty Corn Production Systems
While the vast majority of corn grown in the U.S. is grown as grain for animal feed, ethanol,
and industrial uses, a
pproximately 8 percent of corn grown in the U.S. (2005/06 growing season)
is specialty corn specified by buyers and end-users of corn (USGC, 2006, 2008). Specialty corns
include: sweet, high oil, nutritionally-enhanced corn varieties, and organically-produced varieties
(USGC, 2006). Due to premiums offered by end-users and the dramatic adoption by U.S.
farmers of GE corn varieties, specialty corn products are receiving increased attention as
potentially profitable alternatives to the products of conventional and GE corn production
systems (Elbehri, 2007).
Product differentiation and market segmentation in the specialty corn industry includes
mechanisms to keep track of the grain (traceability) for Identity Preservation (IP) and quality
assurance processes (e.g., ISO9001-2000 certification), as well as contracts between growers and
buyers that specify delivery agreements (Sundstrom et al., 2002). Systems used by specialty
corn growers and end-users to maintain identity of the production include:
Contracts – written agreements detailing responsibilities and duties of both parties including
premiums for reaching goals and penalties for failing to attain specifications;
Tracking and Traceability Systems – correct labeling of all products (planting seeds and
harvested material) and testing procedures for identifying and detecting acceptability of
materials;
Quality Assurance Processes – oversight on handling procedures, testing of planting seeds,
and testing of harvested materials to determine acceptability of use and product
requirements, and assuring testing procedures are appropriate; and
• Closed-Loop Systems – the end-user supplies the planting seeds and guarantees to purchase
final products. This may also require that the end-user conduct intermediate procedures such
as planting, providing oversight during the growing season, harvesting, and transportation to
processing plant.
IP systems that have been shown to be successful in the past include seed certification systems
conducted by members of American Organization of Seed Certifying Agencies (AOSCA)
(AOSCA, 2009). To maintain the purity of the corn product, this production system is based on
controlling, tracking, and documenting each step from seed production to end use (processing
plants).
2.1.2.3 Organic Corn Production Systems
Organic farming is defined in this document to include any production system that falls under the
USDA-National Organic Program (NOP) definition of organic farming and is a certified organic
production system. The NOP is administered by the USDA-Agricultural Marketing Service
(AMS). Organic farming operations, as described by the USDA-NOP, require organic
production operations to have distinct, defined boundaries and buffer zones to prevent
unintended contact with excluded methods from adjoining land that is not under organic
11
management. Organic production operations must also develop and maintain an organic
production system plan approved by their accredited certifying agent. This plan enables the
production operation to achieve and document compliance with the National Organic Standards,
including the prohibition on the use of excluded methods. In organic systems, the use of
synthetic pesticides, fertilizers, and genetically engineered crops (e.g., MON 87460) is strictly
limited or restricted.
Organic certification involves oversight by an accredited certifying agent of the materials and
practices used to produce or handle an organic agricultural product (7 CFR 205.300). This
oversight includes an annual review of the certified operation’s organic system plan and on-site
inspections of the certified operation and its records. Although the National Organic Standards
prohibit the use of excluded methods (7 CFR 205.272), they do not require testing for the
presence of excluded methods. Thus, NOP certification is dependent on process and not product.
The unintentional presence of the products of excluded methods will not affect the status of an
organic product or operation when the operation has not used excluded methods, and when the
operation has taken reasonable steps to avoid excluded methods. However, retailers often
require organic and non-GE farmers to verify their harvests through various tests (Ruth, 2003).
In 2007 (the date of the last USDA Census of Agriculture), 93.5 million acres of corn were
planted in the U.S., yielding 12.7 billion bushels of corn (USDA, 2009). For the same year,
USDA-ERS reported that 194,637 acres (0.21 percent) out of a total 93.5 million acres planted
were certified organic (USDA-ERS, 2010d).
In 2008, Wisconsin, Iowa, Minnesota, Michigan, New York, Texas, and Nebraska each had more
than 10,000 acres of certified organic corn, totaling approximately 69 percent of all certified
organic acreage in the U.S. (Table 2) (USDA-ERS, 2010d). Generally, acreage increased from
2007 to 2008, although, in some instances, certain states showed a decrease in the number of
certified organic acres.
Table 2: Certified organic corn acreage by state with more than 1,000 acres of
certified land in 2007 and 2008.
State
Acreage
State
Acreage
2007 2008 2007 2008
California 1,305 2,765 New Mexico 2,700 1,552
Colorado 2,445 3,043 New York 1,909 1,459
Illinois 7,319 8,739 North Dakota 3,292 4,761
Indiana 2,414 2,998 Ohio 8,786 8,969
Iowa 24,944 25,419 Oregon 1,072 1,712
Kansas 2,067 4,637 Pennsylvania 4,482 5,918
Maine 1,025 1,237 South Dakota 5,779 5,564
Maryland 1,009 1,239 Texas 7,710 11,202
Michigan 12,722 12,663 Virginia 1,286 1,472
Minnesota 26,849 27,565 Washington 1,970 2,265
Missouri 7,144 3,765 Wisconsin 27,431 33,619
Nebraska 12,226 10,568 U.S. Total 170,905 193,136
Source: “Certified Organic Grains”, Organic Production Data Files (USDA-ERS, 2010d).
12
2.2 Physical Environment
2.2.1 Water Resources
Corn requires a steady supply of moisture, totaling approximately 4,000 gallons through the
growing season to produce 1 bushel of grain (NCGA, 2007). This demand is met by a
combination of natural rainfall, stored soil moisture from precipitation before the growing
season, and supplemental irrigation during the growing season (Neild and Newman, 1990).
Groundwater is the major source for irrigation, used on almost 90 percent of irrigated corn
acreage in the U.S. (Christensen, 2002). In 2007, 13.0 million U.S. corn acres were irrigated,
reflecting 15 percent of all corn acres harvested for grain (USDA-NASS, 2007).
Agricultural non-point source (NPS) pollution is the primary source of discharge pollutants to
rivers and lakes and a major contributor to groundwater contamination. Management practices
that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the
application of pesticides, herbicides, and fertilizers. The primary cause of NPS pollution,
however, is increased sedimentation following soil erosion. Agricultural pollutants released by
soil erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and
streams when they are carried off of fields by rain or irrigation waters (EPA, 2005). Excess
sediment can directly affect fish and other wildlife mortality and reduce the amount of light
penetration into a body of water. Indirectly, soil erosion-mediated sedimentation can increase
fertilizer runoff, facilitating higher water turbidity, algal blooms, and oxygen depletion in a body
of water (EPA, 2005).
2.2.2 Soil
Arable land supports a rich and complex community of below ground microorganisms and
arthropods. The interaction between the below ground community, plant root suture, and organic
residues in the soil is central to a variety of dynamic soil ecological processes, including the
decomposition of organic material, subsequent nutrient cycling and release, and the concomitant
maintenance of soil structure and composition.
Cultivation of corn directly impacts the qualitative and quantitative attributes of soil. As with
any agricultural system, land management options, such as crop type, tillage, and pest
management regime have notably greater effects on the biology of the soil than the type of corn
cultivated (Griffiths et al., 2007a; Griffiths et al., 2007b). For example, conventional tillage and
mechanized harvesting machinery may disturb and expose the top soil surface layer, leaving the
land prone to degradation. In turn, degradation of soil structure and composition may lead to
decreased water retention, a decrease in soil carbon aggregation and net positive carbon
sequestration, and increased emission of radiatively-active gases that contribute to the
greenhouse effect (e.g., carbon dioxide (CO
2
) and nitrous oxide (N
2
O)) (EPA, 2010b; Lal and
Bruce, 1999). Additionally, as previously discussed, land that is prone to degradation is also
more likely negatively affect water resource quality and communities of organisms dependent on
those water resources.
13
2.2.3 Air Quality
There are many measures of air quality relevant to agriculture, such as the Clean Air Act (CAA)
National Ambient Air Quality Standards (NAAQS) criteria pollutants, greenhouse gases
(GHGs), volatile organic compounds (VOCs), pesticides, odors, and airborne allergens. The
seven NAAQS criteria pollutants are carbon monoxide (CO), lead, nitrogen dioxide (NO
2
),
particulate matter between a nominal 2.5 and 10 micrometers in aerodynamic diameter (PM
10
),
particulate matter less than a nominal 2.5 micrometers in aerodynamic diameter (PM
2.5
), ozone
(O
3
), and sulfur dioxide (SO
2
) (EPA, 2010c). Emissions from crop agriculture can be broken
down into two main categories emissions related to working fields, such as dust and equipment
emissions, and emissions from the soil and plants.
Agriculture activities (e.g., field preparation, planting, and harvesting) may generate dust plumes
(PM
10
and PM
2.5
) (Holmén et al., 2006). For example, peak levels of particulate concentrations
coincide with the peak agricultural harvest season in California’s Central Valley (Giles et al.,
2006). Emissions released from agricultural equipment (e.g., irrigation pumps and tractors)
include CO, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (EPA,
2010b). Greenhouse gas (GHG) emissions from agriculture (crops and livestock) are mainly in
the form of methane and nitrous oxide (EPA, 2010b). Other trace gases from agriculture include
carbon dioxide and ammonia (Krupa et al., 2006). Atmospheric wet and dry deposition of
nitrogen, mineral nutrients, and organic compounds to cropping systems can have feedback
effects on trace gas emissions from fields (Krupa, et al., 2006). Agricultural pesticides may also
enter the atmosphere through volatilization from soil and plant surfaces and through wind
erosion and can be returned to the surface through precipitation or dry deposition processes
(Vogel et al., 2008).
2.2.4 Climate Change
Climate change represents a statistical change in climate conditions, and may be measured across
both time and space. Production of agricultural commodities is interrelated with climate change
on several different levels (Dale, 1997; Rosenzweig and Parry, 1994). U.S. agriculture may act
as an affecter of climate change through various facets of the production process. Combustion of
fossil fuels in mechanized farm equipment, fertilizer application, and decomposition of
agricultural waste products may all contribute greenhouse gases to the atmosphere (Aneja et al.,
2009). Greenhouse gases collectively function as retainers of solar radiation, and agriculture-
related activities are recognized as both direct (e.g., exhaust from equipment) and indirect (e.g.,
agricultural-related soil disturbance) sources of CO
2
, methane (CH
4
), and N
2
O (EPA, 2010a).
The U.S. agricultural sector is identified as the second largest contributor to GHG emissions,
ranking only behind the energy sector (i.e., electricity production, transportation, and related
activities) (EPA, 2010a). Agricultural crop commodities may also affect dynamic geophysical
soil processes, such as carbon turnover and sequestration, through tillage and cropping system
practices. In general, reduced/conservation tillage practices favor more stable and increased
carbon sequestration in the agro-environment (Lal, 2004). Additionally, climate change may
also affect agricultural crop production. These potential impacts on the agro-environment and
individual crops may be direct, including changing patterns in precipitation, temperature, and
duration of growing season, or may cause indirect impacts influencing weed and pest pressure
(Rosenzweig et al., 2001; Schmidhuber and Tubiello, 2007).
14
The impacts of GE crop varieties on climate change are unclear, though it is likely dependent on
cropping systems, production practices, geographic distribution of activities, and individual
grower decisions. APHIS will continue to monitor developments that may lead to possible
changes in the conventional production system likely to result from GE products brought to
APHIS for approval. The potential impact of climate change on agricultural output, however,
has been examined in more detail. A recent IPCC forecast (IPPC, 2007) for aggregate North
American impacts on agriculture from climate change actually projects yield increases of 5 to 20
percent for this century. The IPCC report notes that certain regions of the U.S. will be more
heavily impacted because water resources may be substantially reduced. While agricultural
impacts on existing crops may be significant, North American production is expected to adapt
with improved cultivars and responsive farm management (IPPC, 2007).
2.3 Animals and Plant Communities and Biodiversity
2.3.1 Animal Communities
Corn fields have long been known to be utilized by birds, deer, and various small mammals (e.g.,
raccoons (Procyon lotor), deer mice (Peromyscus maniculatus), meadow voles (Microtus
pennsylvanicus), and thirteen-lined ground squirrels (Spermophilus tridecemlineatus) for feeding
and cover.
Bird species that have been observed in rowcrop fields include, among others, blackbirds (e.g.,
red-winged blackbirds (Agelaius phoeniceus)), horned larks (Eremophila alpestris), brown-
headed cowbirds (Molothrus ater), and vesper sparrows (Pooecetes gramineus) (Best and
Gionfriddo, 1991). Specific bird species can act as beneficial or detrimental members in the
agro-environment. For example, red-winged blackbird are often initially attracted to corn fields
to feed on insect pests, but then also feed on the corn. Studies have shown that red-winged
blackbirds can destroy more than 360,000 tons of field corn and substantial amounts of sweet
corn annually (Dolbeer, 1990). Although many birds visit row-crop fields such as corn, numbers
are low and few nest there, likely due to overlap between nesting phenology and mechanized
harvest (Johnson, 2000; Patterson and Best, 1996).
Deer, such as the white-tailed deer (Odocoileus virginianus), find field corn attractive because it
functions both as food and cover throughout the latter half of the growing season (Vercauteren
and Hygnstrom, 1993). Deer can significantly damage or completely destroy small corn fields
that are surrounded by woody or brushy areas; data from the Wisconsin Department of Natural
Resources show approximately $915,000 in corn damage from white-tailed deer in 2008 (Koele,
2008). However, deer damage to large corn fields is often limited to a few rows closest to the
wooded areas (Neilsen, 1995). Raccoon damage to field corn has increased in recent years
(Beasley and Rhodes Jr., 2008). In northern Indiana, Humberg et al. (2007) attributed 87 percent
of corn plants damaged across 100 corn fields over two growing seasons to raccoons. The deer
mouse is the most common small mammal in some corn production regions (Stallman and Best,
1996; Sterner et al., 2003). Deer mice feed on a wide variety of plant and animal matter, but
primarily feed on seeds and insects. They are considered beneficial in agro-ecosystems because
they consume both weed and pest insect species. The meadow vole feeds primarily on fresh
grass, sedges, and herbs, but also on seeds and grains. Meadow voles also can be considered
beneficial for their role in the consumption of weeds, but can be an agricultural pest where
abundant (J. W. Smith, 2005). The thirteen-lined ground squirrel feeds primarily on seeds of
15
weeds and available crops, such as corn and wheat (J. Smith, 2005; Sterner, et al., 2003).
Thirteen-lined ground squirrels have the potential to damage agricultural crops, although they
can also be considered beneficial when eating pest insects such as grasshoppers and cutworms.
Although many of the invertebrate organisms found in corn-producing areas are considered
pests, such as the corn earworm (Helicoverpa zea), European corn borer (Ostrinia nubilalis), fall
armyworm (Spodoptera frugiperda), and the corn rootworm (Diabrotica spp.), many others are
considered beneficial (Hoeft, et al., 2000). For example, numerous invertebrates perform
valuable functions, such as pollinating plants (bees), contributing to the decay of organic matter
(earthworms), cycling soil nutrients (earthworms), and attacking other pest insects and mites
(ladybird beetles).
2.3.2 Plant Communities
The floral community surrounding a corn field is dependent on geography. In certain areas, corn
fields can be bordered by other agricultural fields (including those of other corn varieties),
woodlands, or pasture and grasslands. From an agronomic perspective, the most relevant
members of a surrounding plant community are those that can behave as weeds. Thus, weed
pressure is also dependent on geography. Reductions in corn agronomic performance is
sometimes associated with weed competition for water, nutrients, and light. U.S. corn yields are
threatened by more than 200 weed species annually (Heap, 2008). Common corn field weeds in
Indiana includes giant foxtail (Setaria faberi), giant ragweed (Ambrosia trifida), velvetleaf
(Abutilon theophrasti), common cocklebur (Xanthium strumarium), Canada thistle (Cirsium
arvense), common lambsquarters (Chenopodium album), Johnsongrass (Sorghum halepense),
fall panicum (Panicum dichotomiflorum), and marestail (Conyza canadensis) (Childs, 1996).
Weeds such as giant foxtail (Setaria faberi) and barnyardgrass (Echinochloa crusgalli) have
been shown to reduce corn yields by up to 14 and 35 percent, respectively (Bosnic and Swanton,
1997; Fausey et al., 1997).
Weediness
In the U.S., corn is not listed as a weed (Crockett, 1977; Holm et al., 1979; Muenscher, 1980).
Furthermore, corn is grown throughout the world without any report that it is a serious weed or
that it forms persistent feral populations. Corn is poorly suited to survive without human
assistance and is not capable of surviving as a weed (H. G. Baker, 1965; Galinat, 1988; Keeler,
1989). Like many domesticated crops, corn seed from a previous year’s crop can overwinter and
germinate the following year. For instance, the appearance of corn seedlings in soybean fields
following a corn crop is a common occurrence. Manual or chemical measures are often applied
to remove these volunteers, but the plants that are not removed do not typically result in feral
populations in subsequent years. Corn does not possess the suite of traits that are characteristics
of successful weeds (H. G. Baker, 1965; Keeler, 1989).
APHIS assessed whether MON 87460 is any more likely to become a weed than the isogenic
nontransgenic corn line or other corn varieties currently under cultivation. The assessment
encompasses a thorough consideration of the basic biology of corn and an evaluation of the
unique characteristics of MON 87460 evaluated under field conditions, including potential
weediness traits such as seed dormancy and germination, rate of growth and development,
flowering, seed dispersal, seed yield, and persistence of free-living populations outside
16
cultivation (See Appendix C). Monsanto collected phenotypic and agronomic field data from
field trials conducted at 27 U.S. locations during the 2006 and 2007 growing seasons that
included diverse agro-environments representative of the major corn-growing areas of the upper
mid-west in the U.S. Likewise, Monsanto also collected complimentary data from four field
trials from Chile (Reeves, 2010). In addition, data on abiotic stress tolerance from greenhouse
and growth chamber assays were used to characterize the extent of stress tolerance imparted by
the insertion of the cspB gene and determine whether any potential changes in tolerance
enhanced weediness potential in MON 87460.
2.3.3 Biodiversity
Biodiversity is strongly impacted by agricultural practices, including the type of cultivated plant
and its associated management practices. Species diversity and abundance in corn agro-
ecosystems may differ between conventional, GE, and organic production systems. Relative to
any natural ecosystem, species abundance and richness will generally be less in intensively-
managed agro-ecosystems.
Many studies over the last ten years have investigated the differences in biological diversity and
abundance between GE and non-GE fields, particularly those GE crops that are resistant to
insects (e.g., Bt crops) or herbicides (e.g., glyphosate-tolerant or glufosinate-tolerant crops).
Among the numerous studies, conflicting results are often reported. Different studies have
demonstrated decreases in biological diversity or abundance due to GE crops engineered to
accumulate insecticidal proteins or tolerate herbicide application for weed management
(Marshall et al., 2003; Pilcher et al., 2005; Ponsard et al., 2002). Alternatively, other studies of
GE crops, such as Bt corn, when compared to non-GE crops sprayed with insecticides
demonstrate that GE crops do not cause any changes in arthropod abundance or diversity (Chen
et al., 2008; Romeis et al., 2006; Torres and Ruberson, 2005; N. Weber, 2009; Wolfenbarger et
al., 2008). Some reports show that GE crops may even increase biological diversity in agro-
ecosystems (Marvier et al., 2007; Romeis, et al., 2006). Herbicide-tolerant corn, when compared
to non-GE corn production, may not result in changes in arthropod abundance and may increase
species diversity during different times of the year (Brooks et al., 2003; Haughton et al., 2003;
Hawes et al., 2003; Roy et al.; Wolfenbarger, et al., 2008). Since biological diversity can be
defined and measured in many ways, APHIS considers determining the level of biological
diversity in any crop to be complex and hard to achieve concurrence. Another difficulty with
biodiversity studies is separating expected impacts from indirect impacts. For example,
reductions of biological control organisms are seen in some Bt-expressing GE crops, but are
caused by reduction of the pest host population following transgenic pesticide expression in the
GE crop plant.
2.3.4 Gene Flow
Gene flow is a biological process that facilitates the production of hybrid plants, introgression of
novel alleles into a population, and evolution of new plant genotypes. Gene flow to and from an
agro-ecosystem can occur on both spatial and temporal scales. In general, plant pollen tends to
represent the major reproductive propagule that can transverse space, while both seed and
vegetative propagules tend to promote the movement of alleles across time and space.
17
The rate and success of gene flow is dependent on numerous external factors in addition to the
donor/recipient plant. General external factors related to pollen-mediated gene flow include the
presence/abundance/distance of sexually-compatible plant species; overlap of flowering
phenology between populations; the method of pollination; the biology and amount of pollen
produced; and weather conditions, including temperature, wind, and humidity (Zapiola et al.,
2008). Seed-mediated gene flow also depends on many factors, including the
absence/presence/magnitude of seed dormancy; contribution and participation in various
dispersal pathways; and environmental conditions and events.
Corn is self-compatible and wind-pollinated. In the U.S., there are no native plant species that
can be pollinated by corn pollen without human intervention (e.g., chromosome doubling or
embryo rescue) (Galinat, 1988; Mangelsdorf, 1974; Russell and Hallauer, 1980). However,
teosinte (wild progenitor of corn) can sometimes be found as introduced populations in botanical
gardens and as feral populations of Zea mexicana in Florida, Alabama, Maryland (USDA-NRCS,
2010), and
Zea perennis
in South Carolina (USDA-NRCS, 2011).
Feral populations of the
closely related and sexually compatible subspecies of Z. mays spp. parviglumis have also been
described in a single county (Miami-Dade) of Florida (Weber, 2009). Evidence of introgression
of genes from corn into U.S. teosinte populations has not been sought but complex mechanisms
of incompatibility have been described that are barriers to this potentiality (Kermicle and Evans,
2010).
Corn plants do not produce clonal structures nor can corn plants produce vegetative propagules.
Therefore, asexual reproduction and gene flow as a result of dispersal of vegetative tissues does
not occur with corn.
2.3.4.1 Intraspecies gene flow
Many varieties of corn are cultivated in the U.S. For gene flow to occur between corn varieties,
flowering of the source and sink populations must overlap, pollen transfer must occur,
embryo/seeds must develop, and hybrid seed must disperse and establish. Corn is a monoecious,
out-crossing, wind-pollinated crop that produces abundant, large, and heavy pollen. The
reproductive morphology of corn encourages cross-pollination between corn plants and there is
no evidence (genetic or biological barriers) to indicate that gene flow is restricted between
genetically modified, conventional, and organic corn.
A variety of plant properties, environmental conditions, and imposed conditions can affect
movement of genes between corn cultivars. These considerations apply separately to include
both pollen-mediated gene flow as well as seed-mediated gene flow (see Appendix B for a
detailed list). Spatial and temporal isolation can be one of the most effective barriers to gene
exchange between corn crop cultivars (Zapiola, et al., 2008). Current practices for maintaining
the purity of hybrid seed production in corn are typically successful for maintaining 99 percent
genetic purity, though higher instances of out-crossing can occur (Ireland et al., 2006). For
example, the NOP has requirements for organic plans to address pollen flow from GE crops that
include recommendations for spatial isolation (Krueger, 2007; G. Kuepper, 2002; G Kuepper et
al., 2007). The Association of Official Seed Certifying Agencies (AOSCA) also has information
for specialty corn crops, and a protocol for growing non-GE corn (AOSCA, 2009).
18
Pollen-mediated gene flow and mitigation
As noted, a primary spatial mechanism to maintain corn genetic purity is isolation distance. A
recent paper reviewed studies investigating gene flow and cross-fertilization studies in corn grain
production fields, and, using the data from these studies, recommended 50 meters (m)
(approximately 164 feet (ft)) as the distance needed to isolate GE corn from non-GE corn
(Sanvido et al., 2008). The authors limited their analysis to studies that confirmed fertilization in
the non-GE corn plants, and excluded studies on pollen dispersal that only measured pollen flow,
because pollen flow does not necessarily result in fertilization (Sanvido, et al., 2008). Successful
cross-fertilization requires many different biological and physical factors, such as synchrony of
flowering between corn fields, viability of pollen, and presence of physical barriers, and thus
pollen dispersal is not equivalent to cross fertilization. Sandivo et al. (2008) analyzed existing
studies and found that the cross-fertilization rate in non-GE corn typically remained below 0.5
percent at this distance. This result was validated when large scale studies were analyzed for
cross-fertilization events (Henry et al., 2003; W. E. Weber et al., 2007).
An isolation strategy alone may or may not be adequate for limiting gene flow, depending upon
seed varieties used and local conditions. One study found cross-fertilization to be as high as 2.5
percent at 660 ft, which is the isolation distance used by AOSCA to isolate corn fields for seed
production (AOSCA, 2009). One potential reason for the discrepancy between this study and
many other gene flow studies in corn may be due to the type of corn used in the Jones and
Brooks study. Jones and Brooks (1950) investigated the appropriate isolation distance for seed
production in open-pollinated varieties, and not in hybrid varieties. Due the biology of open-
pollinated varieties, these types of plants may be more receptive to pollen over a longer period of
time than hybrid corn plants (Sanvido, et al., 2008), allowing for a greater chance of pollination
events. Thus the results from Jones and Brooks (1950) may be an overestimation of cross-
fertilization potential for hybrid corn plants. Additional properties also may affect pollen-
mediated gene flow from corn and are listed in Appendix B.
Seed-mediated gene flow and mitigation
For gene flow to occur via seeds and result in feral populations of corn, seeds must disperse and
establish in new habitats. Through thousands of years of selective breeding by humans, corn has
been extensively modified to depend on human cultivation for survival (Galinat, 1988). Several
key weedy traits that would contribute to crop escape, traits associated with ferality and
volunteerism, have been selectively reduced in corn, resulting in a domesticated crop species not
equipped for survival without management (Gould, 1968). Also, several traits greatly reduce the
ability of corn to disperse via seeds. Humans have selected corn to produce seeds that do not
shatter and cannot disperse from the cob, and corn seeds are tightly bound within a protective
sheath of leaves, or husk (Galinat, 1988). Corn seeds also lack dormancy, preventing easy
persistence between seasons in fields or in the weed seed bank. While corn grains or cobs left in
fields after harvest can result in volunteers in the following year, these volunteers are unlikely to
produce progeny and persisting populations because of the tightly bound nature of the corn seeds
to the husk. Specific properties affecting seed-mediated gene flow from corn are listed in
Appendix B.
19
2.4 Human Health
2.4.1 Public Health
In the past 30 years, the public’s consumption of corn-based products has more than doubled
corn products have risen from 12.9 pounds annually per capita in 1980 to 33 pounds in 2008; and
corn sweeteners have risen from 35.3 pounds annually per capita in 1980 to 69.2 pounds in 2008
(USCB, 2011). During the same time period, the share of corn that is genetically engineered has
risen from zero to 80 percent (USDA-ERS, 2010a). Due to concurrent increases in corn
production consumption and the increased adoption of GE corn, the general concern with GE
corn is exposure through human and animal consumption.
Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the
products they market are safe and properly labeled. Food and feed derived from any GE crop
must be in compliance with all applicable legal and regulatory requirements. GE organisms for
food and feed may undergo a voluntary consultation process with the FDA prior to release onto
the market. Although a voluntary process, applicants who wish to commercialize a GE variety
that will be included in the food supply invariably complete a consultation with the FDA. In a
consultation, a developer who intends to commercialize a bioengineered food meets with the
agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding
the bioengineered food and then submits to FDA a summary of its scientific and regulatory
assessment of the food; FDA evaluates the submission and responds to the developer by letter.
As noted by the National Research Council (NRC), unexpected and unintended compositional
changes arise with all forms of genetic modification, including both conventional hybridizing
and genetic engineering (NRC, 2004). The NRC also noted that at the time, no adverse health
effects attributed to genetic engineering had been documented in the human population. More
recently, the NRC stated that GE crops have had fewer adverse effects on the environment than
non-GE crops (NRC, 2010). Reviews on the nutritional quality of GE foods have generally
concluded that there are no significant nutritional differences in conventional versus GE plants
for food or animal feed (Faust, 2002; Flachowsky et al., 2005).
2.4.2 Worker Safety
Agriculture is one of the most hazardous industries for U.S. workers. As a result, Congress
directed the National Institute of Occupational Safety and Health to develop a program to
address high-risk issues related to occupational workers. In consideration of the risk of pesticide
exposure to field workers, EPA revised its Worker Protection Standard (40 CFR Part 170) in
1992 to further protect field workers from the hazards of pesticide exposure. Furthermore, the
Occupational Safety and Health Administration require all employers to protect their employees
from hazards associated with pesticides and herbicides.
Pesticides, including herbicides, are used on most corn acreage in the U.S., and changes in
acreage, crops, or farming practices can affect the amounts and types of pesticides used and thus
the risks to workers. Pesticide registration, however, involves the design of use restrictions that
if followed have been determined to be protective of worker health.
20
2.5 Livestock Health
Approximately 55 to 60 percent of the corn produced in the U.S. is used for livestock (KyCGA,
2011). As with human consumption of corn, most of the corn used currently for livestock feed is
GE (USDA-ERS, 2010a). Similar to human consumption, there is a general concern regarding
the impact of GE components on nutritional, allergenic, and toxicological aspects of the food
produced by livestock.
Similar to the regulatory control for direct human consumption of corn under the FFDCA, it is
the responsibility of feed manufacturers to ensure that the products they market are safe and
properly labeled. Feed derived from GE corn must comply with all applicable legal and
regulatory requirements, which in turn protects human health. To help ensure compliance, GE
organisms used for feed may undergo a voluntary consultation process with FDA before release
onto the market, which provides the applicant with any needed direction regarding the need for
additional data or analysis, and allows for interagency discussions regarding possible issues.
2.6 Socioeconomic
2.6.1 Domestic and Trade Economic Environment
Domestic demand for corn in the U.S. comes from its domestic use for feed, ethanol production,
food, and seed, and totaled 11.1 billion bushels in the 2009/10 marketing year (USDA-ERS,
2011b). Exports added another 2 billion bushels to total U.S. corn use. Demand is satisfied
almost entirely by domestic supply, with few imports, the U.S. being largely a net exporter of
corn. The U.S. produced 13 billion bushels of corn in the 2009/10 marketing year and corn
occupied the most acreage of any crop in the country (USDA-ERS, 2011b). In the 2009/10
marketing year, feed was approximately 40 percent of U.S. corn production, ethanol production
was about 35 percent of U.S. corn use, food, seed, and industrial uses were approximately 45
percent, and exports the remaining 15 percent (USDA-ERS, 2011b). Seeds constituted
approximately 1.7 percent of domestic corn production, with 5.6 percent being used for high
fructose corn syrup, glucose and dextrose, and corn starch (USDA-ERS, 2010c).
Corn is grown in the entire continental U.S. Despite this broad cultivation range, most U.S.
production is centered in the Corn Belt. The Corn Belt includes Iowa, Illinois, Nebraska, and
Minnesota, and parts of Indiana, South Dakota, Kansas, Ohio, Wisconsin, and Missouri, and
represents approximately 80 percent of U.S. annual corn production (USDA-NASS, 2010a).
Corn production requires approximately 20 inches of soil moisture during the growing season to
achieve maximum yields. Many U.S. corn-producing states have average annual precipitation
below 20 inches annually. Among those states, those with most non-irrigated acreage of corn
harvested are North Dakota, Colorado, Montana, New Mexico, and Wyoming. The states with
the most irrigated acreage of corn harvested are Nebraska, Kansas, Texas, Colorado, and
California (USDA, 2009). Of these, all but California are in the Great Plains area of corn
production. Figure 2 shows the corn acres harvested for grain in the U.S. that are irrigated
(USDA-NASS, 2007b).
21
Figure 2. Irrigated corn for grain, harvested acres: 2007.
Source: 2007 Census Publications, Ag Atlas Maps, Crops and Plants (Map 07-M164, USDA-NASS 2007b).
Table 3: Relative importance of farms and corn in local economies.
Area
Share (percent) of Farms in
Total Gross Domestic
Product (2007)
a
Share (percent) of Corn in
Total
Crop Acreage (2010)
b
California 1.24 14.30
Colorado 1.05 21.69
Kansas 3.00 20.89
Minnesota 2.12 37.72
Montana 3.89 24.03
Nebraska 6.93 46.07
New Mexico 1.72 46.07
North Dakota 10.29 9.43
South Dakota 9.03 28.16
Texas 0.79 10.07
Wyoming 1.07 5.41
United States 1.00 27.55
Sources: (a) Bureau of Economic Analysis, Gross Domestic Product by State, Crop and Animal
Production (NAICS 111 and 112); (b) National Agriculture Statistics Service, Acreage, Area Planted for
All Purposes.
22
Table 3 shows the relative importance of farming and corn in the 11 states mentioned above and
in the U.S. The first column shows the share of state gross domestic product (GDP) generated
by crop and animal farms. This does not include GDP generated by supporting activities (e.g.,
for soil preparation, harvesting, or post-harvesting), nor does it include transportation activities
or processing and commercialization of products downstream from farm production. In all listed
states but Texas, farms generate a higher share of GDP than the U.S. average. The second
column shows the share of corn in total crop acreage as an indicator of the relative importance of
corn in crop farming in each state. Given the value of corn as feed, corn also has an important
role in animal farms.
Additionally, there is a niche market for non-GE food and feed in the U.S., as evidenced by
private labeling initiatives such as the Non-GMO Project, that offers third-party product
verification and labeling for non-GE products (Non-GMO-Project, 2010). There also is a
growing niche market for organic products in the U.S. Sales of organic products have been
growing quickly, having grown from $1 billion in 1990 to $24.8 billion in 2009, representing a
5.1 percent between 2008 and 2009 (OTA, 2010). However, in the case of organic corn
production, there is some evidence that supply might be lagging behind demand (Greene et al.,
2009). To satisfy the demand for either organic or non-GE corn, producers have had to adopt
specific production practices to maintain and prevent the contamination of excluded methods as
dictated by the USDA-NOP. To offset the increase in investment related to these more extensive
practices, premiums are often paid for non-GE or organic corn. For example, in 2007,
conventional corn averaged $4.19/bushel, whereas organic corn averaged $7.08/bushel (N.
Weber, 2009).
The U.S. is the largest world exporter of corn. Trade in feed for livestock has been a driver of
trade in corn (USDA-ERS, 2011b). Japan is the world’s largest corn importer, typically
followed by South Korea, Mexico, Egypt, and Taiwan (USDA-FAS, 2010b). During the last
half decade, the U.S. share of world corn exports averaged 60 percent, the second largest
exporter being Argentina (USDA-ERS, 2011b).
The primary U.S. corn export destinations are also the largest world importers of corn and do not
seem to have major barriers for importing GE products. In Japan there are no restrictions for
import of GE varieties that have been approved for commercialization in Japan. In the case of
genetically engineered varieties not yet approved in Japan, a 1 percent presence in feed is still
allowed, as long as it has been approved by an exporting country with safety assessments
equivalent to Japan’s. There is no restriction after approval. Labeling is mandatory for GE food
when the GE content can be detected and if the GE ingredient is one of the first three ingredients
of a product and accounts for more than 5 percent of its total weight (Greuere, 2006). Mexico
imports and consumes regularly existing varieties of GE corn (USDA-FAS, 2008b). South
Korea has similar approval processes as Japan and requires labeling for GE animal feed (USDA-
FAS, 2008). Taiwan requires labeling for products containing more than 5 percent GE content
(USDA-FAS, 2008c). Egypt is a large consumer of GE crops, including corn, soybeans, and
vegetable oils (USDA-FAS, 2006).
Data on trade in organic corn is not readily available but given that U.S. corn imports are
relatively small and that U.S. organic corn production is a small share of the total, trade in
organic corn is likely to be a very small share of the total corn trade.
23
The affected trade economic environment is defined as those countries with which the U.S.
engages in corn feed, seed and food trade. Therefore, the trade economic environment most
likely affected by deregulating DT Corn would be those countries who import DT Corn feed,
seed and food.
The affected domestic environment is defined as any land in the U.S. that is currently producing
crops that could incorporate a corn rotation, as well as land that could be converted from inactive
cropland to active cropland, and land currently in the CRP that could be removed from the
program and farmed.
24
3 ALTERNATIVES
This document analyzes the potential environmental consequences of a determination of
nonregulated status of Monsanto Company MON 87460 corn. To respond favorably to a petition
for nonregulated status, APHIS must determine that MON 87460 is unlikely to pose a plant pest
risk. Based on its PPRA (USDA-APHIS, 2010) APHIS has concluded that MON 87460 is
unlikely to pose a plant pest risk. Therefore APHIS must determine that MON 87460 is no
longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act.
Two alternatives will be evaluated in this EA: (1) no action and (2) determination of
nonregulated status of MON 87460. APHIS has assessed the potential for environmental
impacts for each alternative in the Environmental Consequences section.
3.1 No Action Alternative: Continuation as a Regulated Article
Under the No Action Alternative, APHIS would deny the petition. MON 87460 and progeny
derived from MON 87460 would continue to be regulated articles under the regulations at 7 CFR
Part 340. Permits issued or notifications acknowledged by APHIS would still be required for
introductions of MON 87460 and measures to ensure physical and reproductive confinement
would continue to be implemented. APHIS might choose this alternative if there were
insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of
MON 87460.
This alternative is not the preferred alternative because APHIS has concluded through a PPRA
(USDA-APHIS, 2010) that MON 87460 is unlikely to pose a plant pest risk. Choosing this
alternative
would not satisfy the purpose and need of making a determination of plant pest risk
status and responding to the petition for nonregulated status.
3.2 Preferred Alternative: Determination that MON 87460 CORN Is No Longer a
Regulated Article
Under this alternative, MON 87460 and progeny derived from them would no longer be
regulated articles under the regulations at 7 CFR Part 340. MON 87460 is unlikely to pose a
plant pest risk (USDA-APHIS, 2010). Permits issued or notifications acknowledged by APHIS
would no longer be required for introductions of MON 87460 and progeny derived from this
event. This alternative best meets the purpose and need to respond appropriately to a petition for
nonregulated status based on the requirements in 7 CFR part 340 and the agency’s authority
under the plant pest provisions of the Plant Protection Act.
Because the agency has concluded
that MON 87460 is unlikely to pose a plant pest risk, a determination of nonregulated status of
MON 87460 is a response that is consistent with the plant pest provisions of the PPA, the
regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the
Coordinated Framework.
Under this alternative, growers may have future access to MON 87460 and progeny derived from
this event if the developer decides to commercialize MON 87460.
25
3.3 Alternatives Considered But Rejected from Further Consideration
APHIS assembled a list of alternatives that might be considered for MON 87460. The agency
evaluated these alternatives, in light of the agency's authority under the plant pest provisions of the
Plant Protection Act, and the regulations at 7 CFR part 340, with respect to
environmental safety,
efficacy, and practicality to identify which alternatives would be further considered for MON
87460. Based on this evaluation, APHIS rejected several alternatives. These alternatives are
discussed briefly below along with the specific reasons for rejecting each.
3.3.1 Prohibit Any MON 87460 from Being Released
In response to public comments that stated a preference that no GE organisms enter the
marketplace, APHIS considered prohibiting the release of MON 87460, including denying any
permits associated with the field testing. APHIS determined that this alternative is not
appropriate given that APHIS has concluded that MON 87460 is unlikely to pose a plant pest
risk (USDA-APHIS, 2010).
In enacting the Plant Protection Act, Congress found that
[D]ecisions affecting imports, exports, and interstate movement of products regulated
under [the Plant Protection Act] shall be based on sound science… § 402(4).
On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies,
the White House Emerging Technologies Interagency Policy Coordination Committee developed
broad principles, consistent with Executive Order 13563, to guide the development and
implementation of policies for oversight of emerging technologies (such as genetic engineering)
at the agency level. In accordance with this memorandum, agencies should adhere to Executive
Order 13563 and, consistent with that Executive Order, the following principle, among others, to
the extent permitted by law, when regulating emerging technologies:
“[D]ecisions should be based on the best reasonably obtainable scientific, technical,
economic, and other information, within the boundaries of the authorities and mandates
of each agency”
Based on our
Plant Pest Risk Assessment (USDA-APHIS 2010) and the scientific data
evaluated therein, APHIS concluded that MON 87460 is unlikely to pose a plant pest risk
.
Accordingly, there is no basis in science for prohibiting the release of MON 87460.
3.3.2 Approve the Petition in Part
The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole
or in part."
For example, a determination of nonregulated status in part may be appropriate if
there is a plant pest risk associated with some, but not all lines described in a petition.
Because
APHIS has concluded that MON 87460 is unlikely to pose a plant pest risk,
there is no
regulatory basis under the plant pest provisions of the Plant Protection Act for considering
approval of the petition only in part.
26
3.3.3 Isolation Distance between MON 87460 and Non-GE Corn Production and
Geographical Restrictions
In response to public concerns of gene movement between GE and non-GE plants, APHIS
considered requiring an isolation distance separating MON 87460 from conventional or
specialty corn production. However, because APHIS has concluded that MON 87460 is
unlikely to pose a plant pest risk (USDA-APHIS, 2010), an alternative
based on requiring
isolation distances would be inconsistent with the statutory authority under the plant pest
provisions of the Plant Protection Act and regulations in 7 CFR part 340.
APHIS also considered geographically restricting the production of
MON 87460
based on the
location of production of non-GE corn in organic production systems or production systems for
GE-sensitive markets in response to public concerns regarding possible gene movement between
GE and non-GE plants. However, as presented in APHIS’ PPRA for
MON87460
, there are no
geographic differences associated with any identifiable plant pest risks for
MON 87460
(USDA-
APHIS, 2010). This alternative was rejected and not analyzed in detail because APHIS has
concluded that
MON 87460
does not pose a plant pest risk, and will not exhibit a greater plant
pest risk in any geographically restricted area. Therefore, such an alternative would not be
consistent with APHIS’ statutory authority under the plant pest provisions of the Plant Protection
Act and regulations in Part 340 and the biotechnology regulatory policies embodied in the
Coordinated Framework.
Based on the foregoing, the imposition of isolation distances or geographic restrictions would not
meet APHIS’ purpose and need to respond appropriately to a petition for nonregulated status
based on the requirements in 7 CFR part 340 and the agency’s authority under the plant pest
provisions of the Plant Protection Act. Nevertheless, APHIS is not expecting significant effects.
However, individuals might choose on their own to geographically isolate their non-GE rose
productions systems from MON 87460 or to use isolation distances and other management
practices to minimize gene movement between corn fields. Information to assist growers in
making informed management decisions for
MON 87460
is available from Association of
Official Seed Certifying Agencies (AOSCA 2004).
3.3.4 Requirement of Testing for MON 87460
During the comment periods for other petitions for nonregulated status, some commenters
requested USDA to require and provide testing for GE products in non-GE production systems.
APHIS notes there are no nationally-established regulations involving testing, criteria, or limits
of GE material in non-GE systems.
Such a requirement would be extremely difficult to
implement and maintain. Additionally, because
MON 87460
does not pose a plant pest risk
(USDA-APHIS, 2010)
, the imposition of any type of testing requirements is inconsistent with
the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and
biotechnology regulatory policies embodied in the Coordinated Framework. Therefore,
imposing such a requirement for
MON 87460
would not meet APHIS’ purpose and need to
respond appropriately to the petition in accordance with its regulatory authorities.
27
3.4 Comparison of Alternatives
Table 4 presents a summary of the potential impacts associated with selection of either of the
alternatives evaluated in this EA. The impact assessment is presented in Section 4 of this EA.
Table 4: Summary of Potential Impacts and Consequences of Alternatives.
Attribute/Measure Alternative A: No Action
Alternative B: Determination
of Nonregulated Status
Meets Purpose and Need
and Objectives
No Yes
Unlikely to pose a plant pest
risk
Satisfied through use of
regulated field trials
Satisfied – risk assessment
(USDA-APHIS 2010)
Management Practices
Acreage and Areas of Corn
Production
Unchanged Minimal
Cropping practices Unchanged Unchanged
Pesticide use Unchanged Unchanged
Seed Corn Production Unchanged Unchanged
Organic Farming Unchanged Unchanged
Impact to Specialty Corn Unchanged Unchanged
Environment
Water use Unchanged Unchanged
Soil Unchanged Unchanged
Air Quality Unchanged Unchanged
Climate Change Unchanged Unchanged
Animals Unchanged Unchanged
Plants Unchanged Unchanged
Biological Diversity Unchanged Unchanged
Gene Movement Unchanged Minimal
Human and Animal Health
Risk to Human Health Unchanged Unchanged
Risk to Worker Safety Unchanged Unchanged
Risk to Animal Feed Unchanged Unchanged
Socioeconomic
Domestic Economic
Environment
Unchanged Unchanged
Trade Economic
Environment
Unchanged Unchanged
Social Environment Unchanged Unchanged
Other U.S Regulatory
Approvals
FDA completed
consultations
FDA completed
consultations
Compliance with Other Laws
28
Attribute/Measure Alternative A: No Action
Alternative B: Determination
of Nonregulated Status
CWA, CAA, EOs Fully compliant Fully compliant
*Unchanged – no significant change expected
*Minimal – possibly small changes but no significant differences
29
4 ENVIRONMENTAL CONSEQUENCES
This analysis of potential environmental consequences addresses the potential impact to the
human environment from the alternatives analyzed in this EA, namely taking no action and a
determination by the agency that MON 87460 does not pose a plant pest risk. Potential
environmental impacts from the No Action Alternative and the Preferred Alternative for MON
87460 are described in detail throughout this section. A cumulative effects analysis is also
included for each affected environment. Certain aspects of this product and its cultivation would
be no different between the alternatives: those are described below.
4.1 Scope of Environmental Analysis
The scope includes any land in the U.S. currently producing corn, any land that is currently
producing crops that could incorporate a corn rotation, as well as land that could be converted
from inactive cropland to active cropland, and land currently in the Conservation Reserve
Program (CRP) that could be removed from the program and farmed. Conversion of grassland,
forest, or other land types to cropland as a result of deregulating MON 87460 would be less
likely because these types of conversions have not been notable contributors to cropland over the
past 18 years; therefore, APHIS does not consider them to be part of the affected environment in
this EA. Furthermore, as described below, MON 87460 is unlikely to significantly increase
future corn acreage beyond USDA-ERS projected expansion in irrigated U.S. corn production
regions. The MON 87460 trait is intended to increase grain yield security under conditions of
moderate water stress. Minimum moisture requirements are similar between MON 87360 and
conventional corn and therefore MON 87360 is not anticipated to expand corn acreage into areas
not currently used for corn production.
To determine areas of corn production, APHIS used data from the National Agricultural
Statistics Service (NASS) 2007 Census of Agriculture to determine where corn is produced in
the United States (USDA, 2009). Corn grain was commercially produced in all states except
Alaska.
4.2 Other Assumptions
The environmental consequences of the different alternatives described above will be analyzed
under the assumption that farmers, who produce conventional corn,
MON87460,
or produce
corn using organic methods, are using reasonable, commonly accepted best management
practices for their chosen system and varieties during agricultural corn production. However,
APHIS recognizes that not all farmers follow these best management practices for corn. Thus,
the analyses of the environmental affects will also include the assumption that some farmers do
not follow these best management practices.
The environmental consequences will be discussed under the context of the MON 87460
phenotype presented in the Monsanto 87460 Petition for Determination of Nonregulated Status.
In summary, MON 87460 does not exhibit improved grain yield relative to the near-isogenic
control corn variety when subject to well-watered conditions. When other indicators of MON
87460 agronomic performance are compared to a variety of regionally-adapted corn reference
hybrids and the near-isogenic control variety, MON 87460 neither significantly nor consistently
30
performs beyond the observed range of variation, further reinforcing the lack of increased
agronomic performance in MON 87460 under well-watered conditions (Reeves, 2010).
When subject to water-limited conditions (<50 percent field capacity), MON 87460 displays
significantly less yield loss relative to the near-isogenic control corn variety. However, other
measures of the MON 87460 phenotype do not significantly deviate from the range of values
produced by the near-isogenic control or regionally-adapted corn reference hybrids Combined
with data demonstrating no significant differences between MON 87460 or its control corn
variety in rate of soil moisture depletion, root:shoot ratio, and cold, heat, and salt stresses, the
quantified agronomic attributes of MON 87460 under water-limited conditions confirms its
single and predicted phenotype (Reeves, 2010). These data provide multiple lines of evidence
indicating that the cspB trait plays a physiological role in modulating plant drought response
through increased photosynthetic efficiency and does not provide an absolute increase in the rate
of soil water depletion or improved fitness outside the agricultural environment (Plant Pest Risk
Assessment (PPRA) for MON 87460 (APHIS, 2011)).
4.3 Agricultural Production of Corn
4.3.1 Current Acreage and U.S. Cultivation Range
USDA-APHIS is tasked with protecting the health and value of American agriculture and natural
resources. Continued regulation of genetically engineered organisms and encouragement of best
management practices, regardless of farmer decision to cultivate GE or non-GE crop varieties,
represents two central, practical methods to maintain and improve U.S. agricultural productivity.
At present, U.S. farmers are projected to increase planted corn acreage from 86.5 million acres in
2009/10 to 92 million acres in 2020/21(USDA-ERS, 2010b, 2011b). The Midwest (~65 percent)
and the Great Plains (~26 percent) represent the major corn-producing regions of the U.S. GE
corn varieties represent a progressively increasing proportion of total U.S. corn planted, ranging
from a low of 25 percent in 2000 to 86 percent in 2010 (USDA-ERS, 2010a). While the majority
of currently commercialized GE corn varieties represent either herbicide-tolerant (e.g.,
glyphosate-, glufosinate-tolerant or other herbicide) or insect resistant (i.e., Cry protein
expression) varieties, an increasing proportion are varieties with multiple stacked traits (i.e.,
herbicide-tolerant and insect-resistant) (USDA-ERS, 2010a).
During the market year September 2009 through August 2010, 86.4 million acres of corn were
planted and approximately 134 million bushels of corn were harvested (USDA-ERS, 2010b). Of
the total harvest, about 39 percent was used for animal feed and residuals, 35 percent was used
for biofuels production, 10 percent was used for food and industrial purposes (not including
alcohol for fuel), 0.17 percent was used as seed stock for hybrid seed production, 13 percent
remained as ending stock seed, and 15 percent was exported for various uses in overseas markets
(USDA-APHIS, 2010).
4.3.1.1 No Action Alternative: Current Acreage and U.S. Cultivation Range
Under the No Action Alternative, MON 87460 and its progeny would continue to be regulated
articles under the regulations at 7 CFR part 340.. Independent of the No Action Alternative, both
U.S. total corn acreage and the proportion of acreage planted with GE corn varieties is expected
to incrementally increase through 2019, as indicated by USDA-ERS projections and previous
31
trends of GE corn adoption (USDA-ERS, 2011b). Increased demand for animal feed in the
livestock industry, favorable net returns for corn ethanol production, and the readily available
number of regionally-adapted corn hybrid varieties is likely to sustain this increase in domestic
corn cultivation, with additional corn acreage planted primarily at the expense of other crops
(e.g., wheat and soybean) (USDA-ERS, 2011b). Former CRP land returned into agricultural
production may also provide land for additional corn acreage, though this contribution is likely
to be minimal due to minimal projected net reduction in U.S. CRP acreage from 2011 to 2020
(USDA-ERS, 2011b).
Conventional corn production with GE varieties will continue to increase independently of a
determination of non-regulated status of MON 87460, based on overall trends from previous
years, and USDA-ERS modeling projections of corn production and demand. Market demand
across all consumer sectors is anticipated to dictate overall increases in U.S. corn acreage. Corn
will continue to be commercially cultivated in 49 U.S. states, with the majority of production
centered in Midwestern U.S. Corn Belt states under the No Action Alternative.
4.3.1.2 Preferred Alternative: Current Acreage and U.S. Cultivation Range
MON 87460 is designed to provide increased yield security in current corn-producing areas that
are subject to moderate drought stress. As indicated in data presented by the Monsanto
Company and the APHIS Plant Pest Risk Assessment of MON 87460 (Reeves, 2010; USDA-
APHIS, 2010) the phenotype of MON 87460, with the exception of reduced yield loss under
conditions of moderate drought stress, is similar to that of conventional corn. Like other
domesticated corn varieties, MON 87460 does not exhibit traits that would allow it to establish
outside the agricultural environment. Consequently, the cultivation range of MON 87460 is
similar to that of conventional corn. A determination of nonregulated status of MON 87460
under the Preferred Alternative will likely lead to cultivation in areas that already support
economically viable corn production.
In general, areas such as the Midwestern U.S. Corn Belt or any other region that receives
sufficient precipitation (>30 inches) to routinely support high levels of corn production are
unlikely to adopt MON 87460 due to a lack of improved agronomic performance under well-
watered conditions (Figure 3). These well-watered corn production regions generally do not
require supplemental irrigation and represented 85 percent of total corn cultivation area in 2007.
A determination of nonregulated status of MON 87460 is unlikely to lead to adoption and
significantly expand corn acreage in these areas primarily due to the absence of grower benefit
when subject to well-watered conditions.
32
Figure 3. Average values for U.S. corn harvest and average annual precipitation
(1971-2000).
Source: Data derived from the PRISM climate group database (http://www.prism.oregonstate.edu/) and USDA-NASS
(USDA-NASS, 2007).
When subject to water-limited conditions (<50 percent field capacity), MON 87460 displays
significantly less yield loss while retaining similar measures of growth and developmental
characteristics relative to conventional corn. Corn production regions subject to frequent
moderate drought conditions may require supplemental irrigation, including the western dryland
Great Plains and similar regions, and these represented 15 percent of all corn production regions
in 2007. A determination of nonregulated status of MON 87460 under the Preferred Alternative
is unlikely to significantly increase future corn acreage beyond USDA-ERS projected expansion
in irrigated U.S. corn production regions. The MON 87460 trait is intended to increase grain
yield security under conditions of moderate water stress. Minimum moisture requirements are
similar between MON 87360 and conventional corn. When grown in water-limited field and
greenhouse conditions, MON 87460 corn exhibits classic drought sensitivity symptoms,
including reductions in yield, plant height, ear height, seedling vigor, and expected changes in
plant height, chlorophyll content, and leaf roll (Reeves, 2010). The magnitude of these changes
in MON 87460 under drought conditions is similar to that of water-limited conventional corn,
with increasing water deficit producing increasingly severe growth and developmental
symptoms. Taken in total, these data demonstrate that the negative effects of drought stress in
MON 87460 are not alleviated and strongly suggest that areas unable to support economically
viable production of conventional corn will also not support production of MON 87460, thus
precluding the significant expansion of acreage in current irrigated corn production areas.
33
It is prudent to acknowledge, however, that the reduced yield phenotype of MON 87360 does not
exceed the natural variation observed in regionally-adapted varieties of conventional corn
(representing different genetic backgrounds) (Reeves, 2010). Thus, equally comparable varieties
produced through conventional breeding techniques are readily available in irrigated corn
production regions. Despite the availability of conventional drought tolerant corn varieties in
these irrigated corn production regions, recent agronomic trends suggest that increases in corn
acreage are often undertaken at the expense of other crops (e.g., wheat) on arable land or the
return of former agricultural land (i.e., CRP land) into productivity, and not through cultivation
of novel areas never managed for agricultural production now or in the foreseeable future (Table
5). Additionally, irrigated corn acreage and percent irrigated corn acreage in the Great Plains
region has been relatively stable, despite the availability of conventionally-produced drought
tolerant corn varieties (Figure 4). The increase in corn acreage in 2007 was observed across the
U.S. in general, and was not specific to the Great Plains dryland region (USDA-ERS, 2010b).
This further suggests that MON 87460, with its reduced yield phenotype not exceeding that
observed in conventionally-produced drought tolerant corn varieties, will not significantly alter
present trends in irrigated corn acreage.
Several reasons can be advanced for why corn acreage will not expand into areas not currently
used for corn production. Existing drought tolerant varieties and conventional corn have similar
moisture requirements and physiological responses to drought as do MON 87460. Also, adoption
of MON 87460 is unlikely in the corn production in regions that are 85 percent well-watered and
not requiring supplemental irrigation. Although conventionally-produced drought tolerant corn
has been accessible to growers, there has been no associated expansion into novel areas in corn
production regions. For these reasons, APHIS does not anticipate that a determination of
nonregulated status of MON 87460 will significantly increase corn acreage beyond projected
values nor alter current trends in crop production.
Table 5. Acreage for major field crops and Conservation Reserve Program (CRP)
assumptions, long-term projections (USDA-ERS, 2011b).
Planted Acreage (million acres)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Planted acreage, eight major crops
Corn 86.5 88.2 92.0 91.5 91.0 90.5 90.5 90.5 91 91.5 92.0 92.0
Sorghum 6.6 5.4 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0
Barley 3.6 2.9 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.2
Oats 3.4 3.1 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0
Wheat 59.2 53.6 57.0 55.5 54.5 53.0 52.0 51.5 51.5 51.5 51.0 51.0
Rice 3.1 3.6 3.3 3.2 3.2 3.2 3.3 3.3 3.3 3.3 3.3 3.3
Upland
Cotton
9.0 10.8 12.8 12.5 12.2 12.0 11.9 11.8 11.8 11.7 11.7 11.6
Soybeans 77.5 77.7 78.0 78.3 78.5 79.0 79.5 79.5 79.5 79.5 79.5 79.5
Total 248.9 245.3 255.3 253.2 251.1 249.9 248.9 248.8 249.3 249.7 249.7 249.6
CRP acreage assumptions
Total CRP 33.7 31.4 31.9 31.9 31.9 31.9 31.9 32.0 31.9 31.9 31.9 31.9
Total plus
CRP
282.6 276.7 287.2 285.0 283.0 281.9 280.8 280.8 281.2 281.6 281.6 281.5
34
Figure 4. Total, irrigated, and percent irrigated corn acreage in the western
dryland Great Plains.
Values represent the average of irrigated acreage in Colorado, Kansas, Montana, Nebraska, New Mexico,
North Dakota, Oklahoma, South Dakota, Texas, and Wyoming (USDA, 2009)
4.3.1.3 Cumulative Effects: Current Acreage and U.S. Cultivation Range
Cumulative effects of a determination of nonregulated status of MON 87460 are unlikely.
Neither the No Action Alternative nor Preferred Alternative of a determination of nonregulated
status of MON 87460 will directly cause an increase in agricultural acreage devoted to corn
production beyond projected USDA-ERS increases. There are no anticipated changes to the
availability of GE and non-GE corn varieties on the market under either alternative. The
projected increase in corn acreage that occurs independently of MON 87460 will be sustained by
both market demand for corn products and the large number of corn hybrid varieties that are
readily available to growers.
4.3.2 Cropping Practices
Corn is an extensively managed crop plant, requiring significant management considerations
regarding tillage, agricultural inputs, and rotation strategy. Decisions concerning corn
agronomic practice are dependent on grower want and need, and ultimately reflective of external
factors including geography, weed and disease pressure, economics of management of yield, and
production system [rotation] flexibility (Giannessi, 2005; Olson and Sander, 1988). For
example, corn intended for grain is likely to require less tillage and frequency of
herbicide/pesticide application relative to seed corn, due to the increased vigor and increased
resistance to pest and disease of hybrid corn varieties relative to inbred corn lines.
Consequently, choice of management practice often dictates marketability of a corn product,
with certain agricultural consumer sectors stipulating requirements and restrictions regarding
corn production methods.
Of the numerous agricultural inputs required for corn grain production, moisture readily impacts
growth and yield. Inadequate moisture at any stage of development is detrimental to the plant,
0
20
40
60
80
100
0
5000000
10000000
15000000
20000000
25000000
1992 1997 2002 2007
%irrigated
Cornacreage
Year
Totalacreage Irrigatedacreage Percentirrigatedacreage
35
though water deficit during grain fill is most strongly correlated with reduced kernel number and
weight. For example, four consecutive days of visible wilting prior to tassel development or
anthesis can reduce grain yields by 25 percent. This same duration of stress during grain fill can
cause a 40 to 50 percent yield reduction (Hesterman and Carter, 1990). In contrast to water
stress impacts during vegetative growth, subsequent irrigation after water-deficient conditions
cannot mitigate the negative impacts of drought on corn productivity and grain yield.
4.3.2.1 No Action Alternative: Cropping Practices
Under the No Action Alternative, MON 87460 will continue to be regulated, and corn production
will continue as currently practiced. Corn will continue to be cultivated under a variety of
management strategies and sold to a variety of markets. Maintaining the regulated status of
MON 87460 under the No Action Alternative will not impact number of corn varieties available
for growers, a large number estimated between 1000 (Pioneer, 2008) and 4000 (Monsanto,
2010). Widespread adoption of GE corn will continue in the U.S., easily accounting for the
majority of corn produced.
Current corn management practices are likely to continue under the No Action Alternative.
Growers make choices to use certain pesticides based on weed, insect and disease pressures, cost
of seed and other inputs, technology fees, human safety, potential for crop injury, and ease and
flexibility of the production system (Olson and Sander, 1988). No-till production of corn will
continue to increase under the No Action Alternative, effectively mitigating the negative impacts
of conventional tillage and associated soil erosion (Fawcett and Caruana, 2001). Additionally,
agronomic practices involving the application of external inputs, such as herbicide, pesticide, and
moisture, will remain as it is practiced today. As an example of the pesticides used during the
production of field corn, the Pesticide Action Network has an online database, including a
detailed description of all the pesticides used in corn agriculture in California (Kegley et al.,
2010). It lists the top 50 pesticides (e.g., herbicides, insecticides, fungicides) used in California
corn production. Any effects due to crop rotation, tillage and pesticide use in the agricultural
production of seed corn and commercial corn will remain the same under the No Action
Alternative. Rotation strategies for corn will continue as practiced today, with market demand
and available technology strongly influencing corn rotation practices, under the No Action
Alternative.
4.3.2.2 Preferred Alternative: Cropping Practices
Under the Preferred Alternative, a determination of nonregulated status of MON 87460 is
unlikely to significantly impact cropping practices in non-irrigated corn production regions, as
these regions already receive sufficient precipitation to limit adoption. These corn cropping
practices include tillage choices, type and frequency of agricultural inputs, and crop rotation
strategies. Consequently, corn cropping practices in these regions are unlikely to be significantly
impacted by MON 87460 due to the low likelihood of adoption.
A determination of nonregulated status of MON 87460 and adoption in target regions, including
the western dryland Great Plains and similar areas subject to frequent and moderate drought
stresses, is also unlikely to significantly impact corn cropping practices. MON 87460 exhibits
similar agronomic and growth characteristics to conventional corn, with the exception of reduced
grain yield loss under water-limiting conditions. Consequently, it is not anticipated that MON
36
87460 will significantly differ from conventional corn in responding to fertilizer or moisture
application. In particular, MON 87460 displays similar soil moisture depletion rates and
physiological responses to water-limiting conditions as conventional corn, strongly suggesting
that irrigation practices for optimal grain yield between MON 87460 and conventionally-
produced drought tolerant corn varieties will not differ.
MON 87460 is designed to constitutively express the E. coli cspB RNA chaperone. No pesticide
(e.g., glyphosate tolerance or Bt protein production) traits are co-engineered into the MON 87460
event. Despite the absence of herbicide tolerant or insect resistant traits in MON 87460,
pesticide use is not anticipated to change existing trends following its adoption in irrigated corn
production regions. While agricultural trends in total pesticide use is currently debated
(Benbrook, 2009; Fernandez-Cornejo, et al., 2009), adoption rates of GE herbicide-tolerant or
pesticide-resistant corn varieties in select western dryland Great Plains states that participate in
the USDA-ERS Corn Estimating Program (Table 6) indicate that substantial corn acreage is
subject to regular pesticide application. Introduction of herbicide-tolerant corn varieties, in
particular glyphosate-tolerant corn, has not significantly affected corn acreage managed with
total herbicide application (Figure 5). However, MON 87460 may facilitate a shift in specific
herbicide product use. While use trends in the six most frequently applied herbicides in 2005
demonstrate relatively stable total herbicide use, both glyphosate and mesotrione application area
have progressively increased since 2000 (Figure 5). If MON 87460 is offered without tolerance
to glyphosate, it may signal a shift away from glyphosate and an increased reliance on other
herbicide products. Similarly, a shift could also occur in insecticide application, if the drought
tolerant trait were offered without an insect-resistance trait in MON 87460. Given typical corn
offerings, corn hybrid varieties produced with MON 87460 will be highly likely to be stacked
with other nonregulated pesticide traits since stacks of traits represent an increasing proportion of
commercially-available corn varieties (Table 6). Based upon this observation, overall impact to
current corn pesticide use practices are likely to be minimal. Adoption rates of stacked varieties
are also likely to increase over time, as demonstrated by previous trends (USDA-ERS, 2010a).
Accordingly, because of the popularity of herbicide tolerant crops, levels of tillage are likely to
continue as currently practiced.
Table 6. Percentage of herbicide-tolerant, insect-resistant,
stacked trait, and total GE corn in select Great Plains states.
State
Herbicide
tolerant
(%)
Insect
resistant (Bt)
(%)
Stacked
(%)
Total
GE
(%)
Kansas 28 22 40 90
Nebraska 24 27 45 96
North Dakota 34 22 37 93
South Dakota 29 6 60 95
Wyoming 27 18 40 85
Source: (USDA-ERS, 2010a).
37
Figure 5. Herbicide application trends in U.S. corn production, 2000-2005.
Source: (http://www.nass.usda.gov/).
Note: Trends represent the six most frequently applied herbicides in corn (2005)
4.3.2.3 Cumulative Effects: Cropping Practices
A determination of nonregulated status of MON 87460 is not anticipated to have any cumulative
effect on tillage, agricultural input practices, or rotation strategies related to U.S. corn
production. MON 87460, with the exception of the phenotype of reduced yield loss under
conditions of moderate drought stress, will not require significantly different crop production
practices compared to other corn varieties. The requirements for crop rotation, tillage, and
herbicide and pesticide use for both MON 87460 and any hybrid progeny produced from it will
be exactly the same as those used for current corn varieties available to growers.
4.3.3 Organic
Certified organic corn represented 0.2 percent (194,637 acres) of the 93.6 million planted U.S.
corn acres in 2007 (USDA-ERS, 2010d). The 2007 certified organic corn acreage represents an
increase of approximately 9 percent from the 131,000 certified organic acres in 2005. Based on
certified organic trends, it can be anticipated that organic acreage devoted to corn production will
increase over time.
Organic farming operations, as described by the National Organic Program (NOP) and
administered by the USDA-AMS, must have distinct, defined boundaries and buffer zones
between adjoining land not under organic management to prevent unintended contact with
prohibited substances (7 CFR 205.272). Organic production operations must also develop and
maintain an organic production system plan approved by their accredited certifying agent (7 CFR
205.201). This plan enables the production operation to achieve and document compliance with
the NOP, including the NOP prohibition on the use of excluded methods. Excluded methods
0
20
40
60
80
100
2000 2001 2002 2003 2005
%ofacresapplied,A.I.
Year
Totalherbicide
Atrazine
Glyphosate
Acetochlor
Nicosulfuron
S‐Metolachlor
Mesotrion
38
include methods used to genetically modify organisms or otherwise influence their growth and
development by means not possible under natural conditions or processes.
Typically, there is more than one method for farms under organic practices to prevent unwanted
pollen or seed from entering their fields including: isolation of the farm, physical barriers or
buffer zones between organic production and non-organic production, as well as formal
communications between neighboring farms (NCAT, 2003). The organic plan used as the basis
for organic certification should include a description of practices used to prevent or reduce the
likelihood of unwanted GE pollen or seed at each step in the farming operation, including
planting, harvesting, storing and transporting the crop (Krueger, 2007; G Kuepper, et al., 2007;
Riddle, 2004). Organic plans should also include mechanisms to monitor the risk of GE pollen or
seed co-mingling with the organic crop (G Kuepper, et al., 2007). Farmers using organic
methods are requested to let neighboring farmers know that they are using organic production
practices and request that the neighbors also help the organic farmer reduce contamination events
(Krueger, 2007; NCAT, 2003). Thus, commonly used production practices for corn, and the
practical methods typically used by corn farmers using organic methods currently provide many
measures that greatly reduce the likelihood of accidental gene flow between GE and non-GE
corn fields. Efficacy of certified organic plans and practices to prevent the likelihood of
unwanted substances is best represented by the parallel increases in both GE corn and organic
corn production since 2000. These practices protect organic crops and thus maximize profits and
price premiums accorded to corn under organic production. APHIS will assume that farmers are
already using, or have the ability to use, these common practices as APHIS’ baseline for the
analyses of the following alternatives below.
4.3.3.1 No Action Alternative: Organic
Current availability of seed for conventional (both GE and non-GE) corn varieties, and those
corn varieties that are developed for organic production, are expected to remain the same under
the No Action Alternative. Under the No Action Alternative, MON 87460 and its progeny
would continue to be regulated articles under the regulations at 7 CFR part 340. This however,
will not change the ready availability of other corn hybrid varieties produced through GE
methods. GE corn will continue to represent a large majority of corn production acreage, with
GE corn totaling 86 percent of all corn production in the U.S. in 2007 (USDA-ERS, 2010a).
Trends of conventional and organic commercial corn production will not change and will remain
the same under the No Action Alternative. Planting and production of GE corn varieties and
organic corn have both increased due to market demands over the last ten years, and these
markets are likely to continue to increase under the No Action Alternative.
4.3.3.2 Preferred Alternative: Organic
A determination of nonregulated status of MON 87460 is unlikely to significantly impact organic
farmers that choose not to plant or sell corn products produced through genetic engineering or
other non-organic production systems. Despite the wide-spread adoption of conventional and
GE corn in the U.S. that amounted to 99.8 percent of total corn production in the U.S. in 2007,
organic corn production has also continued to expand in recent years (USDA-ERS, 2010d).
This continued expansion of organic corn acreage, though minor relative to non-organic national
and state corn production, reinforces the capacity of current organic system plans to avoid use of
excluded methods (and thus, loss of NOP certification) and the efficacy of these plans to
39
increasingly produce agricultural products to meet demand of target markets in spite of the
overwhelming presence of non-organic farming systems.
States that represented major organic corn production areas (> 10,000 acres) in the 2007
Agricultural Census included Iowa, Michigan, Minnesota, New York, and Wisconsin (Table 7).
Organic corn production in these states represented 0.16 to 1.25 percent of total corn production
in each state. Despite the presence of millions of corn acres produced through excluded
methods, no organic grower in this, or any other organic corn production region, has lost organic
certification status. Thus, presently certified methods to maintain organic production as
prescribed by the National Organic Program is effective in the maintenance of organic corn
production. Accordingly, regions that are not anticipated to adopt MON 87460, GE varieties
currently represents the majority of cultivated corn, organic corn production would still represent
a fraction of total corn production and prescribed NOP methods would be just as effective in
preserving certified organic status.
Table 7. Non-organic and organic corn production (harvested acres) in 2007. Data
were calculated from the 2007 Agricultural Census (USDA, 2009).
State
Total Corn
Production
(acres harvested)
*
Percent
Non-organic
Organic Corn
Production
(acres harvested)
**
Percent
Organic
Alabama 288,881 100 0 0
Alaska 1 100 0 0
Arizona 61,408 100 0 0
Arkansas 587,858 99.992 45 0.008
California 675,445 99.588 2,780 0.412
Colorado 1,172,893 99.893 1,257 0.107
Connecticut 32,347 99.975 8 0.025
Delaware 200,827 100 0 0.000
Florida 100,542 99.978 22 0.022
Georgia 510,709 99.991 48 0.009
Hawaii 3,641 99.918 3 0.082
Idaho 333,022 99.999 4 0.001
Illinois 13,214,365 99.947 7,031 0.053
Indiana 6,528,585 99.977 1,533 0.023
Iowa 14,075,332 99.841 22,330 0.159
Kansas 3,847,088 99.903 3,746 0.097
Kentucky 1,409,781 99.990 138 0.010
Louisiana 726,897 100 0 0
Maine 28,703 98.631 393 1.369
Maryland 533,903 99.733 1,427 0.267
Massachusetts 21,575 99.754 53 0.246
Michigan 2,658,538 99.465 14,231 0.535
Minnesota 8,352,731 99.726 22,864 0.274
40
Table 7. Non-organic and organic corn production (harvested acres) in 2007. Data
were calculated from the 2007 Agricultural Census (USDA, 2009).
State
Total Corn
Production
(acres harvested)
*
Percent
Non-organic
Organic Corn
Production
(acres harvested)
**
Percent
Organic
Mississippi 888,049 100 0 0
Missouri 3,332,832 99.898 3,410 0.102
Montana 83,344 99.996 3 0.004
Nebraska 9,438,807 99.903 9,200 0.097
Nevada 6,006 100 0 0
New Hampshire 14,611 99.966 5 0.034
New Jersey 100,766 99.991 9 0.009
New Mexico 136,008 99.512 664 0.488
New York 1,099,413 98.754 13,703 1.246
North Carolina 1,028,533 99.933 689 0.067
North Dakota 2,528,921 99.953 1,189 0.047
Ohio 3,834,164 99.767 8,926 0.233
Oklahoma 301,443 99.999 3 0.001
Oregon 88,692 95.407 4,074 4.593
Pennsylvania 1,427,111 99.653 4,954 0.347
Rhode Island 2,549 100 0 0
South Carolina 388,481 100 0 0
South Dakota 4,841,686 99.933 3,245 0.067
Tennessee 838,499 99.998 16 0.002
Texas 2,121,694 99.859 2,990 0.141
Utah 68,303 100 0 0.000
Vermont 93,876 98.714 1,207 1.286
Virginia 530,781 99.816 974 0.184
Washington 294,929 97.651 6,927 2.349
West Virginia 46,918 100 0 0
Wisconsin 4,074,833 99.247 30,673 0.753
Wyoming 86,740 99.618 331 0.382
Note: * and ** represent corn for grain, corn for silage, popcorn, and sweet corn.
Source: Data were calculated from the 2007 Agricultural Census (USDA, 2009)
4.3.3.3 Cumulative Effects: Organic
Under both the No Action Alternative and the Preferred Alternative, a determination of non-
regulated status of MON 87460 will not change market demands for corn produced through
organic methods. A determination of nonregulated status of MON 87460 will add another GE
corn variety to the conventional corn market. Conventionally produced corn (including GE corn)
represents the vast majority of corn in states that produce organic corn, and a determination of
nonregulated status of MON 87460 is not anticipated to significantly increase GE corn
41
production in these areas. Thus, presently-approved methods for the production of organic corn
are sufficient to preserve certified organic status. Organic corn production will likely increase in
spite of the surrounding conventional corn production whether or not MON 87460 is
deregulated
pursuant to Part 340 and the Plant Protection Act
.
4.4 PHYSICAL ENVIRONMENT
4.4.1 Water Usage and Water Quality
Approximately 4,000 gallons of water is required to produce 1 bushel of corn (NCGA, 2007).
Water use by corn is generally related to growth and development; prior to tassel
development/anthesis, corn generally requires 0.1 inches per day; during grain fill, this water
requirement increases to generally 0.3 inches per day (McWilliams 2002). Relative to other
monocot crop plants, corn generally requires more water for optimal grain yield; however, this
amount is generally less than dicot crop plants, due to increased photosynthetic efficiency in
carbon fixation.
Agricultural non-point source (NPS) pollution is the primary source of discharge pollutants to
above- and underground bodies of water. Many different factors affect that NPS pollution
frequency and amount, including the type of crop cultivated, plowing and tillage, and the
application of fertilizers, herbicides, and pesticides (EPA, 2005). Discharge pollutants can occur
in the form of direct chemical contaminants (fertilizer, herbicide, or pesticide derived) or direct
physical particulates (erosion-related sediments), and indirectly contribute to higher water
turbidity, increased algal blooms, and decreased oxygen content in a body of water (EPA, 2005).
4.4.1.1 No Action Alternative: Water Usage and Water Quality
Under the No Action Alternative, management practices that affect NPS frequency and
abundance in current corn production systems would not change. MON 87460 will continue to
be regulated, and thus, its interaction with water quality and usage will continue to be limited to
areas that were approved for regulated release by APHIS. Water use and water quality in these
release areas will not change, as MON 87460 will continue to share management practices with
conventionally produced corn.
4.4.1.2 Preferred Alternative: Water Usage and Water Quality
The physiological response of MON 87460 is similar to that of conventional corn, with the only
exception being reduced yield loss under water-limiting conditions. When subject to water
deficit, both MON 87460 and conventional corn display similar magnitudes of effect on corn
drought stress indicators, including but not limited to plant height, days to 50 percent pollen
shedding/silking, grain moisture, and leaf chlorophyll content. The reduced yield loss phenotype
of MON 87460 is not enabled by increased water uptake, as demonstrated by several lines of
evidence. Firstly, patterns of shoot and root fresh/dry weight between MON 87460 and
conventional corn are not significantly different under well-watered or water-limited conditions
(Reeves, 2010). If water uptake were increased in MON 87460, it is plausible that shoot/root
fresh weight would be increased in MON 87460 while root/shoot dry weight remained similar
compared to conventional corn. This pattern, however, was not observed and its absence
suggests that water uptake is not increased in MON 87460. The absence of increased water
uptake is further validated by soil moisture depletion studies, where no significant differences in
42
soil moisture depletion rates were observed between MON 87460 and conventional corn
(Reeves, 2010). Taken in total, the physiological evidence and recorded measures of moisture
depletion strongly indicate that MON 87460 does not inherently transport more water than
conventional corn. Consequently, MON 87460 is unlikely to directly and significantly impact
soil moisture availability, abundance, and usage in corn production regions any differently than
conventional corn.
Additionally, water quality is unlikely to be significantly affected by a determination of
nonregulated status of MON 87460. NPS pollution represents a major source of water quality
impacts on above- and underground bodies of water. A major contributing factor to NPS
pollution is soil erosion-mediated sedimentation and the resulting detrimental effects on soil
structure and agrochemical runoff. The correlation between tillage practice and soil erosion is
well documented, as is the correlation between no-tillage or reduced-tillage production systems,
adoption rates of herbicide tolerant crops, and improved soil structure and quality. No-tillage or
reduced-tillage strategies in corn production are contingent on continued herbicide use. MON
87460 is not anticipated to significantly affect herbicide use, and thus, is not anticipated to
significantly affect no-till or reduced-till systems currently utilized in corn production systems.
Accordingly, adoption of MON 87460 is unlikely to cause changes in current water quality
trends associated with corn production practices.
4.4.1.3 Cumulative Effects: Water Usage and Water Quality
A determination ofnonregulated status of MON 87460 is not anticipated to have any cumulative
effect on water use or quality in current corn production regions. Water use is not significantly
different between MON 87460 and conventional corn. Additionally, water quality as the result
of NPS pollution in corn production regions is unlikely to be significantly different between
MON 87460, as no-tillage or reduced tillage strategies will continue to be available and utilized
in corn production regions.
4.4.2 Soil
The soil environment in and around corn fields is complex, and rich in microorganisms and
arthropods. The corn root system modifies soil through its close association with several
microbial groups such as bacteria, fungi, and protozoa (Bais et al., 2006). These interactions are
generally complex and occur through multiple pathways. Plants can have direct or indirect
chemical, physical, and biological effects on the soil. Bacteria typically represent the most
abundant microbes in the soil followed by fungi. Collectively, microbial and arthropod groups
play an important and particular role in the nutriment cycling capacity of the soil (Hoeft, et al.,
2000; OECD, 2003). Specific crop management practices used for GE plants, such as pesticide
applications, tillage, and application of inorganic and organic fertilizers can alter soils and the
microbial and arthropod populations associated with it.
4.4.2.1 No Action Alternative: Soil
Under the No Action Alternative, APHIS would not deregulate MON 87460, and its use would
be limited to areas APHIS has approved for regulated releases. Interactions with the soil would
be limited to the areas approved for regulated releases, and would be minor if any, due to the
small proportion of land compared to commercial corn production acreage. Therefore, there
would be negligible impacts on soil under the No Action Alternative.
43
4.4.2.2 Preferred Alternative: Soil
Under the Preferred Alternative, MON 87460 is not anticipated to significantly impact the
quality of the soil on which it is cultivated, nor is it likely to significantly affect microbial
populations or arthropod populations and the dynamic soil processes those organisms modulate.
As previously described, tillage practice is strongly correlated with soil quality in agricultural
production systems. The use of no-till or reduced till practices is unlikely to be significantly
impacted by a determination of nonregulated status of MON 87460, as herbicide application
strategies will continue to be available to facilitate use of low impact tillage practices.
Microbial and arthropod soil populations may be impacted by a corn crop through degradation of
plant tissue following harvest and direct interaction with soil fauna through the corn root system.
Compositional analysis of MON 87460 forage tissue (i.e., stems and leaves) revealed no
significant or consistent differences between it and conventional corn. Additionally, analysis of
the gene products produced by MON 87460, the neomycin phosphotransferase II and cold shock
protein B have been shown to be safe for the environment (Reeves, 2010). In particular, the
NPTII protein has regularly been used in the selection of many transgenic crop varieties that
have been
deregulated pursuant to Part 340 and the Plant Protection Act
, further demonstrating
the safety of this protein. Because of the similarities in composition between MON 87460 and
conventional corn, and the examined safety of the MON 87460 gene products, it is not
anticipated that degradation of MON 87460 plant tissue following grain harvest will significantly
impact microbial and arthropod soil populations compared to conventional corn.
4.4.2.3 Cumulative Effects: Soil
APHIS identified no impacts on the affected environment for soil as a result of the Proposed
Action. Therefore, no cumulative effects on the affected environment for Soil were identified as
a result of the Preferred Alternative.
4.4.3 Air Quality
Air quality may be affected by a variety of agricultural-related activities, including smoke from
agricultural burning, tillage, traffic and harvest emissions, pesticide drift from spraying, and
nitrous oxide emissions from the use of nitrogen fertilizers (Aneja, et al., 2009; Hoeft, et al.,
2000). These agricultural activities individually have potentially adverse environmental impacts
on air quality. Tillage contributes to the release of GHGs because of the loss of CO
2
to the
atmosphere and the exposure and oxidation of soil organic matter (J. B. Baker et al., 2005).
Emissions released from agricultural equipment (e.g., irrigation pumps and tractors) include
carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides
(EPA, 2010b). Nitrous oxide may also be released following the use of nitrogen fertilizer. Aerial
application of pesticides may cause impacts from drift and diffusion. Pesticides may volatilize
after application to soil or plant surfaces and move following wind erosion (Vogel, et al., 2008).
4.4.3.1 No Action Alternative: Air Quality
Under the No Action Alternative, MON 87460 interactions with the air would be limited to
the areas that were approved for regulated releases by APHIS. Cultivation practices associated
with corn production would not be affected. Air quality would still be affected by agronomic
44
practices associated with corn cultivation and commercial corn production such as tillage and
pesticide application.
4.4.3.2
Preferred Alternative: Air Quality
As previously discussed in Section 4.3.3, cropping practices associated with corn cultivation and
commercial production, including tillage and pesticide application, are not likely to be different
between MON 87460 and conventional corn. Thus, a determination of
nonregulated status of
Mon 87460 will not change the use of tillage, use of agriculture equipment, irrigation, pesticide
applications and fertilizer applications in commercial corn production.
The agronomic performance and physical impact of MON 87460 is similar to that of
conventional corn, except under water-limiting conditions. When subject to water-limiting
conditions, MON 87460 exhibits a reduced yield phenotype. Accordingly,
the physical impact
of MON 87460 on air quality is not anticipated to be significantly different from that of
conventional corn, due to the requirement of similar intensive management practices between
MON 87460 and conventional corn.
4.4.3.3 Cumulative Effects: Air Quality
APHIS has not identified any cumulative impacts for this issue. A determination of
nonregulated status of MON 87460 is expected to on air quality due to similar cropping practices
between MON 87460 or conventional corn. Both MON 87460 and conventional corn require
intensive cropping practices for optimum grain yield, resulting in no cumulative impact on air
quality related to those cropping practices.
4.4.4 Climate Change
U.S. agricultural crop production is identified as a major source of GHG emissions, second only
to the U.S. energy sector. Crop production activities contribute directly to emissions of GHGs
through a variety of processes, including the direct combustion of fossil fuels to support
mechanized activities, abundance and frequency of agricultural chemical application (such as
fertilizers) and other management practices, and the degradation of agricultural residues in the
field or processing plant. Classes of crops planted are relevant to climate change, through crop-
dependent management practices and soil impacts. Additionally, geographic location and soil
composition may also affect climate change through alterations in dynamic geophysical soil
processes. Climate change itself may force changes to agricultural practices by altering
agricultural weed and pest pressure (IPPC, 2007). Indirect effects of new crops will be
determined by the traits engineered into organisms and the management strategies used in the
production of these organisms.
4.4.4.1 No Action Alternative: Climate Change
Under the No Action Alternative, APHIS would not deregulate MON 87460, and its use would
be limited to areas APHIS has approved for regulated releases. Agronomic management
practices and phenotypic characteristics regarding MON 87460 are similar to those of
conventional corn; thus, impact between corn varieties would be minimal. Additionally,
measurable effects from these confined field releases would be minor due to the small scale of
management and acreage relative to current corn production systems in the U.S.
45
4.4.4.2 Preferred Alternative: Climate Change
A determination of nonregulated status of MON 87460 is unlikely to significantly affect current
corn management practices. Management decisions regarding agricultural affecters of climate
change, including tillage, agricultural chemical application, and rotational strategies are not
anticipated to differ between MON 87460 and conventional corn. In particular, due to the
continued availability of herbicide choice in MON 87460 management, no-till or reduced till
practices will likely continue to mitigate soil erosion, stabilizing soil quality attributes and
reducing GHG emissions.
Agronomic performance and phenotypic characteristics of MON 87460 is not significantly
different from conventional corn, with the exception of reduced yield loss under water-limiting
conditions. Accordingly, the physical impact of MON 87460 on climate change is not
anticipated to be significantly different from that of conventional corn. Intensive management
will continue to be practiced on a scale similar to current levels of U.S. corn production, because
of the phenotypic equivalence of MON 87460 and conventional corn.
4.4.4.3 Cumulative Effects: Climate Change
APHIS has not identified any cumulative effects for this issue. Agronomic and phenotypic
equivalence between MON 87460 and conventional corn, with the exception of reduced yield
loss under water-limiting conditions, is not anticipated to significantly impact current corn
production strategies, and thus, current agricultural impacts on climate change.
4.5 Animal and Plant Communities
4.5.1 Animal Communities
Corn production systems in agriculture are host to many animal species. Mammals and birds may
seasonally use grain, and invertebrates can feed on the plant during the entire growing season.
The cumulative effects analysis for this issue is found below at “Cumulative Effects: Plants,
Animals, Biodiversity.”
4.5.1.1 No Action Alternative: Animal Communities
Under the No Action Alternative, environmental releases of
MON 87460
would be under APHIS
regulation,
as they have since 2002 (USDA-APHIS, 2010).
Animal incursions would be limited
to regulated field trials and there would be no change in impacts on animals. A consultation with
FDA was successfully completed for
CSPB and NPTII proteins of MON 87460
(Appendix A),
which demonstrated a lack of toxicity and allergenicity of
MON 87460
for human and animal
consumption.
Based upon the FDA consultation, APHIS supports Monsanto’s conclusions that
MON 87460 is considered safe for animal consumption. USDA analysis shows that while some
increase in corn acres is expected, CRP lands in 2011 through 2020 will not change significantly,
so although some of these lands may be used for new corn production, these conversions to corn
will likely be limited.
4.5.1.2 Preferred Alternative: Animal Communities
Under the Preferred Alternative,
MON 87460
would be deregulated. The agronomic practices
used to produce
MON 87460
are the same as those used to produce conventionally grown corn.
46
The introduced gene products of MON 87460 do not contain pesticidal activity and are not
aimed at any target organisms as a control measure.
Therefore, the evaluation of potential effects
on animals of
MON 87460
focuses solely on the
nontarget impacts
from
MON 87460
, especially
the introduced proteins, CSPB and the NPTII
marker protein. APHIS analyzed the potential
impacts of MON 87460 on animal species including (1) exposure from directly contacting or
consuming MON 87460, (2) exposure from increased use of pesticides or herbicides, and (3)
conversion of CRP land to MON 87460 corn production.
Several phenotypic (i.e., appearance or observable physical characteristics) and agronomic (i.e.,
relating to soils and crop production) traits encompassing five general data categories were
evaluated for
MON 87460
including: (1) phenotypic growth and development, including
vegetative and reproductive growth, (2) germination and dormancy, (3) pollen viability and
morphology, (4) plant interactions with insects, diseases, and abiotic stressors, and (5)
persistence in cultivated fields or areas outside of cultivation (Reeves, 2010). No differences
between
MON 87460
and non-drought-tolerant corn were noted except for the intended
drought-tolerant trait.
CSPB is not known to exert any effects on pest and non-pest organisms. Arthropod (pest and
beneficial) abundance was assessed and indicated no significant impact on non-target organisms.
APHIS concludes that no species exposed to MON 87460 showed adverse consequences and that
MON 87460 is not different in its environmental interactions relative to conventional corn.
Because no differences in physical traits or characteristics were observed between
MON 87460
and conventional corn, it is not expected that
MON 87460
would impact the behavior of
arthropods found in or around corn fields.
MON 87460
is not expected to have nutritional effects on any animal species (including
threatened and endangered species) that feed on it. Grain and forage samples of
MON 87460
and a control from several locations were evaluated for major nutrients and secondary
metabolites (Reeves, 2010). The results indicate that
MON 87460
is compositionally and
nutritionally equivalent to conventional corn except for the expression of the transgene proteins
(CSPB and NPTII).
The transgene proteins in
MON 87460
are not expected to affect animals through toxicity or
allergenicity. The donor organism of the CSPB protein,
Bacillus subtilis
, is not pathogenic, is
often used as a food additive, is present in many fermented foods, and has a history of safe
consumption. The FDA acknowledged that enzyme preparations from
Bacillus subtilis
are
generally recognized as safe (FDA, 1999). The petitioner assessed the risks to humans and
animals from the transgene proteins present in the foods and feeds derived from
MON 87460
,
and the results indicated no adverse effects, even at the highest tested dose levels (Reeves,
2010). Furthermore, the CSPB protein represents no more than 0.00007 percent of the total
protein in the grain of
MON 87460
, and neither transgene protein shares any amino acid
sequence similarities with known allergens, gliadins, glutenins, or protein toxins that have
adverse effects on mammals. Because there is no toxicity or allergenicity potential with the
transgene protein of
MON 87460
, there would be no direct or indirect toxicity or allergenicity
impacts on wildlife species that feed on corn or the associated biological food chain of
organisms. A consultation with FDA was successfully completed for
CSPB and NPTII proteins
47
of MON 87460
(Appendix A), which demonstrated a lack of toxicity and allergenicity of
MON
87460
for human and animal consumption.
Former CRP land returned into agricultural production may also provide land for additional corn
acreage, although this contribution is likely to be minimal because of small net reduction in U.S.
CRP acreage by 2020 (USDA-ERS, 2011b).
In the event that farmers converted current CRP
land to
MON 87460
production, some birds and mammals that use CRP land for food and/or
cover may be displaced to nearby areas of similar habitat. The animals that could be present
in CRP areas would vary depending on the region and type of habitat. The CRP was
initially established to protect land against soil erosion by taking lands out of agriculture
production and planting native vegetation. In turn, the native vegetation provided habitat to
wildlife, most notably birds. Many bird species, such as grassland birds (e.g., grasshopper
sparrows [
Ammodramus savannarum]
, lark buntings
[Calamospiza melanocorys]
, western
meadowlarks
[Sturnella neglecta]
, bobolinks
[Dolichonyx oryzivorus]
), ring-necked pheasants
(Phasianus colchicus)
, sage grouse
(Centrocercus urophasianus)
, quail
(family
Odontophoridae)
, and waterfowl use CRP land (Ferris and Siikämaki, 2009).
The introduced gene products of MON 87460 do not contain pesticidal activity and are not
aimed at any target organisms as a control measure. As discussed in Cropping Practices Section
(4.3.3.2 Preferred Alternative), MON 87460 does not contain any herbicide tolerant or insect
resistant traits and adoption of MON 87460, either on its own or stacked with currently
deregulated pesticide traits, is not anticipated to significantly change current corn agricultural
practices.
APHIS has reviewed and accepts the data submitted by the applicant, which are similar to the
data submitted during the FDA consultation process for
the CSPB and NPTII proteins of MON
87460
(Appendix A). No major impacts on animals, either directly or indirectly, are expected
from deregulating
MON 87460; i
mpacts would be similar to the No Action Alternative.
4.5.2 Plant Communities
Corn production acreage is host to many plant species as well. The landscape surrounding a
corn field varies depending on the region. In certain areas, corn fields may be bordered by other
corn (or any other crop); fields may also be surrounded by wooded or pasture/grassland areas.
Therefore, the types of vegetation, including weeds, around a corn field depend on the area where
the corn is planted. A variety of weeds dwell in and around corn fields; those species will also vary
depending on the geographic region where the corn is planted. Corn itself is not sexually
compatible with any other plant species found in the U.S. The cumulative effects analysis for this
issue is found below at “Cumulative Effects: Plants, Animals, Biodiversity.”
4.5.2.1 No Action Alternative: Plant Communities
Under the No Action Alternative, environmental releases of
MON 87460
would be under APHIS
regulation,
as they have since 2002 (USDA-APHIS, 2010).
No changes in impacts on plant
species compared to any current effects due to conventional corn varieties are anticipated.
48
4.5.2.2 Preferred Alternative: Plant Communities
MON 87460
is not expected to become more invasive in natural environments, compete with
native vegetation, or have any different effect on habitat than conventional corn (USDA-
APHIS, 2010). Corn struggles to survive without human assistance and does not possess traits
that are characteristic of successful weeds (H. G. Baker, 1965; Galinat, 1988; Keeler, 1989).
Like many domesticated crops, corn seed from a previous year’s crop can lie dormant over
winter and germinate the following year. For example, corn seedlings often established
themselves in soybean fields following a corn crop. Physical or chemical methods are often
applied to eradicate these corn seedlings. Any seedlings not removed do not typically result in
feral populations in subsequent years.
Possible Weediness of MON 87460
For the majority of the agronomic traits assessed, there were no statistically significant
differences between MON 87460 and nontransgenic control (Reeves, 2010). No biologically
meaningful differences were detected in the germination and dormancy of seed from MON
87460. In particular, the absence of hard seed supports a conclusion of no increased weediness
potential of MON 87460 compared to conventional corn for germination and dormancy
characteristics (Reeves, 2010). No differences were detected in pollen morphology or viability
between MON 87460 and the control (Reeves, 2010). Results from the genotype-environmental
interaction assessments also support the conclusion that MON 87460 has no increased
susceptibility or tolerance to specific diseases, arthropods, or abiotic stressors beyond drought.
Development of a deep root system is typically one of the agronomic traits that have the potential
to enhance weediness in the natural environment. However, that may not be the case with corn,
as inbred lines with poor early root development exhibited higher yields under drought stress
than ones with accelerated early development of roots (Bruce et al., 2002). It has been reasoned
that the improved performance of corn cultivars to drought stress probably comes from better
water use efficiency (Messmer et al., 2009). Finally, MON 87460 was not altered in its ability to
volunteer in cultivated fields or survive in areas not managed for agricultural production
compared to conventional corn.
The data submitted to APHIS indicate that
MON 87460
exhibits no characteristics that would
improve the ability of this corn to survive without human intervention, and that its cultivation
will not interfere with the cultivation of other corn hybrids or result in its uncontrolled spread
into non-agricultural environments. Because
MON 87460
does not possess traits of a successful
weed and would not spread into non-agricultural environments, there would be no impact to
natural environments or habitats.
Possible Weediness of MON 87460 if Hybridized with Other Plants
MON 87460
is not expected to form hybrids with any plant species (including threatened and
endangered species). APHIS evaluated the potential for gene flow to occur from
MON 87460
to sexually compatible wild relatives. As stated previously, cultivated corn is sexually
compatible with its closest relative, teosinte, and with members of the genus
Tripsacum
,
although to a much lesser degree (Mangelsdorf, 1974; OECD, 2003; Wilkes, 1967). Corn and
teosinte are genetically compatible, wind-pollinated, and can hybridize when close to each
other, which is only likely to occur in Mexico and Guatemala because teosinte is not present in
the U.S., except for a few small feral populations of
Zea mexicana
in Alabama, Florida,
49
Maryland (USDA-NRCS, 2010), and
Zea perennis
in South Carolina (USDA-NRCS, 2011).
Tripsacum
species have one less chromosome than corn but can hybridize with corn, although it
is very difficult and requires special techniques, and the hybrids have a high degree of sterility
and are genetically unstable (Mangelsdorf, 1974). Crosses between corn and
Tripsacum
dactyloides
can be made, but only through human intervention and, even then, it is extremely
difficult (CFIA, 1994).
MON 87460
is not likely to hybridize with sexually compatible species
in the U.S. because of differences in factors such as flowering time, geographical separation,
and development factors (Doebley, 1990a, 1990b; Ellstrand et al., 2007; Galinat, 1988).
Tripsacum dactyloides
and
Tripsacum floridanum
would not be affected by
MON 87460
because of the difficulty of hybridizing with these species. The potential impact due to the
limited potential for gene flow into teosinte is not expected to be any different than that of other
cultivated corn varieties. Based on these considerations,
MON 87460
would pose no direct or
indirect impacts on sexually compatible wild relatives.
Other Possible Impacts
The introduced gene products of MON 87460 do not contain pesticidal activity and are not
aimed at any target organisms as a control measure. As discussed in Cropping Practices Section
(Preferred Alternative), MON 87460 does not contain any herbicide tolerant or insect resistant
traits and adoption of MON 87460, either on its own or stacked with currently deregulated
pesticide traits, is not anticipated to change current corn agricultural practices.
Minor impacts on plant populations could occur if farmers converted current CRP land to MON
87460 production. The extent of impacts depends on the amount of CRP land converted to
agriculture. However, the USDA (USDA-ERS, 2011b) sees no increase in corn acreage from
2011 through 2020 and little change in CRP land; and an increase in corn in 2011 appears to be
at the expense of wheat acreage. As previously noted, c
ropland in the U.S. has been declining as
more cropland has been converted to other types of land than other types of land have been
converted to cropland (NRCS, 2011).
Overall, no major impacts on plants, either directly or indirectly, are expected from
deregulating
MON 87460; i
mpacts would be similar to the No Action Alternative.
4.5.3 Biodiversity
Biological diversity, or the variation in species or life forms in an area, is highly managed in
agricultural systems. Farmers typically plant crops that are genetically adapted to grow well in a
specific area of cultivation and have been bred for a specific market. In the case of corn
agriculture, varieties have been developed for food processing needs (e.g., waxy corn), consumer
qualities (e.g., blue corn or white corn), or for use as a vegetable (e.g. sweet corn). In
conventional agriculture, farmers want to encourage high yields from their corn crop, and will
intensively manage the ‘plant communities,’ or weeds, found in corn crops through chemical,
cultural, or mechanical means. Animals, particularly insect and other pest species, will also be
managed through chemical and cultural controls to protect the crop from damage by certain animal
pests. Therefore, the biological diversity in agricultural systems (the agro-ecosystem) is
highly managed and may be lower than in the surrounding habitats.
Biodiversity in an 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
50
management, including selection and use of insecticides and herbicides; and 4) extent of
isolation of the agro-ecosystem from natural vegetation (Southwood and Way, 1970).
4.5.3.1 No Action Alternative: Biodiversity
Under the No Action Alternative, environmental releases of
MON 87460
would be under APHIS
regulation. Animal and plant species that typically inhabit seed corn and commercial production
systems will be continue to be affected by the management plan of typical conventional corn
production, which includes the use of mechanical, cultural, and chemical control methods.
4.5.3.2 Preferred Alternative: Biodiversity
As discussed above in Plant and Animal Communities (of Environmental Consequences section)
the Preferred Alternative is expected to have no impact on animal and plant species (including
threatened and endangered species and critical habitat) for areas where the adoption of MON
87460 would not convert CRP land to MON 87460
production. It is not expected that use of
MON 87460 in existing corn field would result in any changes in herbicide or pesticide
application. Cultivation of MON 87460 seed requires the same agronomic practices as
conventional corn production. Animal and plant species that typically inhabit seed-corn
production systems will be managed as in conventional corn production, likely with the use of
mechanical, cultural, and chemical control methods. Potential overall impacts from the
introduction of MON 87460 into existing cornfields that would not require a change in herbicide
or pesticide use would be similar to the No Action Alternative. Therefore, there would be no
impact to biodiversity under this scenario of the Preferred Alternative.
For actions where: 1) MON 87460 would replace another crop; 2) land would be converted from
inactive cropland to active cropland using MON 87460; 3) planting MON 87460 would require
an increase in pesticide or herbicide use; or 4) CRP lands would be converted to MON 87460
production, the impact to biodiversity would be considered minor based on the following
discussion.
T
he replacement of a different crop (such as soybeans) to MON 87460 may likely result in a
shift in biodiversity (different animals and plants might be present). However, as previously
stated, biodiversity in any agricultural system is highly managed, and rotating from one crop to
MON 87460 would not be likely to affect the overall species richness or abundance.
If farmers substituted organic corn cultivation with MON 87460 cultivation, local biodiversity
could decline. Bengtsson et al. (2005) analyzed the effects of organic farming on species
richness and abundance using meta-analysis of literature published before December 2002. Their
results indicated that, compared to conventional farming systems, organic farming often has
positive effects on species richness and abundance, but that its effects are likely to differ between
organism groups and landscapes. For example, the Bengtsson et al. (2005) review showed that,
on average, organisms were 50 percent more abundant in organic farming systems than
conventional systems, but the results were highly variable between studies and organism groups.
Birds, predatory insects, soil organisms, and plants responded positively to organic farming,
while non-predatory insects and pests did not. The authors suggest that positive effects of
organic farming on species richness can be expected in intensively managed agricultural
51
landscapes, but not in small-scale landscapes comprised of many other habitat types (Bengtsson
et al., 2005).
The biodiversity in agricultural systems is highly managed and is likely lower than in the
surrounding habitats. Therefore, the conversion of inactive cropland or CRP land to MON
87460 production and use of pesticides and herbicides likely may result in a loss of local
biodiversity. The level of impact would depend on the amount of inactive cropland and CRP land
converted to agriculture and the types of herbicides or pesticides used. APHIS cannot predict the
amount of inactive cropland and CRP land that may be converted to MON 87460 production.
As
noted earlier, if all converted CRP land were used to grow corn, the impacts would represent
only 3 percent of all existing corn planting. In addition, USDA- ERS expects that total CRP
lands will change little between 2011 and 2020 (USDA-ERS 2011; see also Environmental
Scope, Section 4.1).
Consequently, no notable impacts on animal and plant populations are
expected to occur at the regional level. Finally, cropland in the U.S. has been declining, as more
cropland has been converted to other types of land than other types of land have been converted
to cropland (NRCS, 2011).
4.5.3.3 Cumulative Effects: Animal and Plant Communities and Biodiversity
No direct or indirect impacts of MON 87460 on plants were determined because MON 87460
does not possess weedy characteristics, and is unlikely to introgress into wild plants or to corn
agriculture. Consequently, no cumulative impacts would be expected.
There may be some potential for certain foreseeable actions to contribute to cumulative impacts
in conjunction with adoption of MON 87460. One action could include industry stacking
together multiple drought tolerant corn varieties with additional traits such as insect resistance,
and herbicide tolerance. Non-regulated GE traits may be stacked with MON 87460 would also
have been evaluated by USDA, EPA and FDA, and will be as safe as the non-transgenic corn
varieties. Continued conversion of inactive cropland and CRP lands to croplands that could be
planted to MON 87460 may lead to a decrease in biodiversity (because of increased used of
herbicides, pesticides and the general effects of agriculture) and displacement of plants and
animals. However, as shown previously, USDA does not expect large scale conversion of CRP
acres to corn production. In CRP land that is converted to corn acreage, adoption of MON
87460 would not result in any cumulative impact on animal and plant communities because corn
cropping practices, including pesticide application, is not anticipated to be significantly different
from conventional corn.
If MON 87460 corn were grown without additional traits, different herbicides would be used
than those typically used in herbicide-tolerant crops, but as demonstrated in the Preferred
Alternative analysis under Cropping Practices, no change to total pesticide application area of
corn would be expected, though shifts in pesticide product use may occur. However, also as
discussed in Cropping Practices Section (4.3.2.2 Preferred Alternative), any shift of specific
pesticide product use would likely be mitigated by hybridization of MON 87460 with other
deregulated herbicide-tolerant or insecticide traits that are likely to be already present in the area.
52
4.5.4 Gene Flow
4.5.4.1 No Action Alternative: Gene Flow
Under the No Action Alternative, environmental releases of
MON 87460
would be under APHIS
regulation. Horizontal gene flow from corn to other organisms would be unlikely to occur. Gene
flow to other GE and conventional crops, to the extent that it occurs will continue to occur, with
little impact on marketing and sales of corn seed and corn for processing.
4.5.4.2 Preferred Alternative: Gene Flow
Pollen- or seed-mediated gene flow would represent potential direct impacts of MON 87460 but
are not expected to pose a greater impact than that of currently cultivated corn varieties. Besides
the ability to exhibit a reduced yield phenotype when subject to water-limiting conditions, MON
87460 does not notably differ from other corn varieties. Under well-watered conditions,
MON
87460
did not notably differ from non-GE comparable varieties (Reeves, 2010). No evidence of
changes to pollen attributes or seed attributes were observed (Reeves, 2010). Gene flow will
therefore be determined by the factors discussed above, including differences in flowering time
between hybrid GE lines and inbred lines (such as some organic crops), distance between a
pollen source and recipient plants, and the impact of environmental factors such as wind,
temperature, and humidity on viability and dispersal of corn pollen.
To review, pollen-mediated gene flow from MON 87460 to U.S. populations of Zea or
Tripsacum species is not likely, with the limited exception of potential gene flow to feral
populations of Zea mays spp. parviglumis in Florida and to less extent, Tripsacum floridanum,
also in Florida. Differences in flowering time between corn and these species, and current
geographic separation of these species from the majority of U.S. corn production, make the
occurrence of natural crosses in the U.S. a very minor impact.
Based on the information detailed in the sections above, pollen-mediated gene flow between corn
crop fields planted with
MON 87460
and neighboring corn fields is not expected to be
substantially different from pollen-mediated gene flow between any other two corn varieties. As
reviewed by Sanvido et al., 2008, pollen-mediated gene flow decreases rapidly with increasing
distance from source crop fields, regardless of corn cultivar or variety. As such, the pollen-
mediated gene flow from MON 87460 will not be substantially different and represents a
minimal impact. Section 2.1.2 describes the cropping practices corn farmers use to maintain
seed purity between corn varieties. Because there were no identified differences in traits
(besides drought tolerance) between conventional and MON 87460, there is no reason to expect
that cropping practices utilized to maintain genetic purity of corn varieties (AOSCA, 2009)
would be any less effective for cultivation of
MON 87460
. Because
MON 87460
exhibits
decreased yield loss under water-limiting conditions (Reeves, 2010), it can be suggested that
drought conditions may increase the risk of pollen-mediated gene flow due to less pollen
abortion or changes in floral phenology. However, no evidence for changes in pollen structure,
function, abundance, or dispersal was reported in MON 87460 under water-limiting conditions
(Reeves, 2010). Under conditions of drought, corn plants (conventional, organic, or GE) can
continue to produce pollen, but the window of fertilization is shortened because of the delaying
effects of drought on deployment of female reproductive structures (silks) and reductions in
pollen viability (R. C. Hall and Twidwell, 2002). Therefore, pollen-mediated gene flow from
MON 87460
under drought conditions would not be expected to differ from conventional corn
53
and would be limited, in part, because of shortened pollen viability as a result of dry conditions
and a reduced window for fertilization on silks of adjacent corn fields.
Seed-mediated gene flow is of minimal concern due to the lack of seed dispersal and feral traits
in corn. As described in Section 2.1.2.2 all corn seed producers (including organic seed
producers) use standard procedures to assure seed quality. In research conducted to evaluate
MON 87460 (Reeves, 2010), the expression of the cspB conveys a drought resistance trait that
decreases yield loss when subject to reduced water conditions. If
MON 87460
seeds were able
to successfully disperse out of crop fields by natural mechanisms (e.g., extreme weather) or
human-mediated mechanisms (e.g., transport), persistence of the corn could not be expected to
produce a feral population because the shatter and dispersal attributes of
MON 87460
are not
reported to be different from conventional corn. The only phenotypic difference between MON
87460 and conventional corn varieties is tolerance of mild drought conditions. Therefore, the
ability to establish and persist as a feral weed would be extremely low and certainly not likely to
be any greater than other varieties of corn. The
drought tolerant modification would
not allow
feral corn seeds to colonize new habitats or become a greater weed, because the trait confers
reduced yield loss and does not alter any other corn traits.
4.5.4.3. Cumulative Effects: Gene Flow
MON 87460 is not likely to increase the impact of gene flow to an extent greater than that of
other corn varieties and would also not likely do so when combined with other GE traits that
have themselves been evaluated as having no traits that would increase potential gene flow.
Additionally, no deregulated GE variety of corn has resulted in a change in the properties
associated with pollen-mediated or seed-mediated gene flow from corn. Therefore, there are no
expected cumulative impacts.
4.6 Human Health
This section focuses on whether the proposed action affects overall public health and worker
safety. For MON 87460, the evaluation of human health impacts involves the potential effects of
the two inserted genes – cold shock protein B (cspB) and neomycin phosphotransferase (nptII) –
and the expressed proteins (CSPB and NPTII). Public health concerns relating to MON 87460
center on food and product safety, including allergenicity, toxicity, and nutritional changes
(Section 4.6.1). Indirect health effects to workers, such as from changes in pesticide use, related
to the farming of MON 87460 are considered (Section 4.6.2). Also, indirect food-safety issues
from livestock feed, such as consumption of animal products from livestock, are addressed
(Section 4.6.3).
4.6.1 Public Health
Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the
products they market are safe and properly labeled. Food and feed derived from MON 87460
must be in compliance with all applicable legal and regulatory requirements. GE organisms for
food and feed may undergo a voluntary consultation process with the FDA prior to release onto
the market. Monsanto consulted with FDA about food and feed derived from MON 87460 and
provided a comprehensive assessment of food and feed safety data on the CSPB and NPTII
proteins in MON 87460. The FDA has determined Monsanto’s submission to be complete (FDA,
54
2010). MON 87460 does not contain a biotechnology-derived plant-incorporated protectant or a
biological control organism, and therefore is not regulated by the EPA.
4.6.1.1 No Action: Public Health
Under the No Action Alternative, MON 87460 would continue to be a regulated article. Human
exposure to this product would be limited to those individuals involved in cultivation under
regulated conditions. Exposure to existing traditional and GE corn would not change under this
alternative. The status of Monsanto's consultation with FDA on the CSPB and NPTII proteins in
MON 87460 would not change under the No Action Alternative.
4.6.1.2 Preferred Alternative: Public Health
Under the Preferred Alternative, it is expected that members of the public would primarily come
in contact with the introduced transgenes (i.e., cspB and nptII) and CSPB and NPTII proteins
through dietary exposure to food and products derived from MON 87460. Generally, proteins
containing cold shock domains are ubiquitous in nature, being present in many plants and
common bacteria, including species that are normally present in gastrointestinal flora. Cold
shock proteins have no known toxicity and are not associated with pathogenicity. Based on the
evidence provided (Reeves, 2010), the CSPB and NPTII proteins are anticipated to present no
potential adverse effects to exposed organisms, including humans, in the environment. The
following paragraphs summarize the supporting information from the safety assessment
performed for CSPB and NPTII proteins found in MON 87460.
Acute oral toxicity studies for the CSPB and NPTII proteins conducted on mice did not result in
any observed adverse effects, even at the highest tested dose levels (Smedley, 2008). A dietary
safety assessment was performed to evaluate the potential risks to humans and animals from
CSPB and NPTII proteins present in the foods and feeds derived from MON 87460. The ratio of
the no observable effect level (NOEL) for CSPB and NPTII to the estimated dietary intake, also
called the margin of exposure (MOE), was estimated to be greater than or equal to 26,700 and
454,000,000 for the U.S. population, respectively. In general, MOEs of more than about 1,000
to 3,000 are considered an adequate margin of safety (GAO, 2001). For children aged 1 through
6 years, representing the age group with the highest corn to body weight ratio (i.e., most
sensitivity), the MOE was greater than or equal to 11,400 and 208,000,000 for CSPB and NPTII,
respectively.
Based on assessments performed with bioinformatic tools, such as the FASTA algorithm and the
PROTEIN and TOXIN6 databases, CSPB and NPTII were shown not to share any amino acid
sequence similarities with known allergens, gliadins, glutenins, or protein toxins which have
adverse effects on mammals (Burzio et al., 2008; Tu, 2009).
The donor organism of the CSPB protein, B. subtilis, has been shown to be not pathogenic.
Additionally, it has been frequently used as a food additive and is found in many fermented
foods which have been safely consumed by humans for a long time. Enzyme preparations from
this organism have been designated by the FDA as generally recognized as safe (GRAS) since
1999 (FDA, 1999b).
The CSPB protein shares a high percent of identity with CSPs present in other bacterial species
widely used by the food industry and with CSD-containing proteins in plant species used as food.
55
The CSPB protein is homologous to the CSP proteins found in the genera Lactobacillus,
Lactococcus, Bifidobacterium, and E. coli, which are normally present in gastrointestinal flora
and, therefore, considered to be safe. The strains of lactic acid bacteria, Bifidobacterium and
Lactobacillus, are the most common type of bacteria used in the dairy industry for preparation of
probiotic products containing live bacterial cultures. In addition, Bacillus, Lactobacillus, and
Lactococcus species containing CSPs are utilized in many food fermentation processes of milk,
meats, cereals, and vegetables.
Digestive fate experiments conducted with the CSPB protein demonstrated that the full-length
protein is rapidly digested in simulated gastrointestinal fluid, a characteristic shared among many
proteins with a history of safe consumption. Proteins that are rapidly digestible in mammalian
gastrointestinal systems are unlikely to be allergens when consumed. Additionally, the CSPB
protein represents no more than 0.00007 percent of the total protein in the grain of MON 87460.
The safety of NPTII has been addressed in multiple publications (EFSA, 2004; Fuchs et al.,
1993a; Fuchs et al., 1993b; Nap et al., 1992). Several products containing NPTII have been
approved by regulatory agencies on a global basis. EPA established an exemption from the
requirement of a tolerance for NPTII for use as a selectable marker in raw agricultural
commodities (40 CFR Part 180.1134). In 2007, the European Food Safety Authority (EFSA)
affirmed its conclusion that the presence of nptII does not pose a threat to human health or the
environment. Moreover, the USDA previously evaluated the safety of NPTII in several
biotechnology-derived commercial crops that have undergone previous safety assessments (e.g.,
so far NPTII was used as a selectable marker in 28 petitions deregulated by APHIS BRS;
http://www.isb.vt.edu/cfdocs/biopetitions1.cfm), including corn.
Compositional comparisons between MON 87460 and conventional corn presented by Monsanto
showed no biologically meaningful differences for grain and forage compositions either for
major nutrients or for secondary metabolites (Reeves, 2010). Therefore, based on this data, it is
reasonable to assume that the foods and feeds derived from MON 87460 can be considered
compositionally equivalent to those derived from conventional corn.
Based on the assessment of laboratory data provided by Monsanto in the submitted petition and
an analysis of the scientific literature (USDA-APHIS, 2010), along with the completion of the
consultation process with FDA regarding the CSPB and NPTII proteins of MON 87460, APHIS
has concluded that under the Preferred Alternative, a determination of nonregulated status of
MON 87460 would have no expected impacts on public health.
4.6.1.3 Cumulative Effects: Public Health
There are no expected impacts on human health related to the Preferred Alternative. APHIS has
determined that there are no past, present, or reasonably foreseeable actions that would aggregate
with effects of the proposed action to affect public health. Therefore, there are no cumulative
effects identified for this issue.
4.6.2 Worker Safety
EPA’s Worker Protection Standard (WPS) (40 CFR Part 170) was published in 1992 to require
actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and
pesticide handlers. The WPS offers protections to more than two and a half million agricultural
56
workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries,
and greenhouses. The WPS contains requirements for pesticide safety training, notification of
pesticide applications, use of personal protective equipment, restricted entry intervals following
pesticide application, decontamination supplies, and emergency medical assistance.
4.6.2.1 No Action: Worker Safety
During agricultural production of corn, agricultural workers and pesticide applicators may be
exposed a variety of EPA-registered pesticides during application of these chemicals to crops.
These chemicals would be expected to include those products currently used for insect pest and
plant pest management. Under the No Action Alternative, exposure to these agricultural
chemicals during corn production would remain the same as under current conditions.
4.6.2.2 Preferred Alternative: Worker Safety
Agricultural production with MON 87460 does not require any change to the agronomic
practices or chemicals currently used (i.e., pesticides) for conventional corn. Therefore, worker
safety issues associated with the agricultural production of MON 87460 would remain the same
as those under the No Action Alternative.
4.6.2.3 Cumulative Effects: Worker Safety
Worker safety issues related to agronomic practices and the use of pesticides during agricultural
production of MON 87460 would remain the same under both alternatives. APHIS has
determined that there are no past, present, or reasonably foreseeable actions that would aggregate
with effects of the proposed action to impact worker health and safety. Therefore, there are no
cumulative effects identified for this issue.
4.7 Livestock Feed
As with human health, livestock ingestion of inserted genes and proteins in MON 87460, with
subsequent human ingestion of livestock food products, is considered one of the primary
concerns in MON 87460. In addition, horizontal transfer of genetic material to gastrointestinal
bacteria is a concern. This section addresses the use of MON 87460 as animal feed, and the
potential effects of this use on livestock health, especially as it pertains to any effects on human
health from ingestion of or other exposure to livestock products such as meat and milk.
4.7.1 No Action: Livestock Feed
Under the No Action Alternative, APHIS would not deregulate MON 87460, and its use would
continue to be limited to areas APHIS has approved for regulated releases. Thus, there would be
no additional risks or benefits to livestock feed safety from MON 87460.
4.7.2 Preferred Alternative: Livestock Feed
As discussed in Sections 4.6.1 an extensive safety evaluation of the inserted genes (cspB and
nptII) and proteins (CSPB and NPTII) expressed in MON 87460 indicated that they are not
expected to be allergenic, toxic, or pathogenic in mammals. Additionally, no gene transfer to
gastrointestinal flora is expected. Both CSBP and NPII proteins have a history of safe
consumption in the context of other food and feeds (FDA, 2010).
57
Compositional analyses of forage and grain tissues from MON 87460 confirmed that the corn
grain and forage derived from MON 87460, and the intended foods and feeds derived from MON
87460, can be considered compositionally and nutritionally equivalent to conventional corn
hybrids that have a history of safe consumption that are currently in commerce. Therefore, any
food, such as meat and milk, derived from animals that are fed MON 87460 are not expected to
differ from food derived from animals fed conventional corn.
The results of a dietary safety assessment indicate that animals exposed to CSPB and NPTII
present in the foods and feeds derived from MON 87460 will be low, with chickens, swine, and
dairy cows consuming only nanogram quantities of each protein per kilogram of body weight
(Reeves, 2010).
The FDA has evaluated horizontal gene transfer from the use of antibiotic resistance marker
genes. The FDA has concluded that the likelihood of transfer of antibiotic resistance genes from
plant genomes to microorganisms in the gastrointestinal tract of humans, animals, or the
environment, is remote (http://vm.cfsan.fda.gov/~dms/opa-armg.html).
Based on the assessment of data provided by the applicant and review of additional literature, the
Preferred Alternative is not anticipated to have any adverse effects on livestock feed and,
consequently, humans.
4.7.3 Cumulative Effects: Livestock Feed
There are no expected impacts on human or livestock health related to the Preferred Alternative.
APHIS has determined that there are no past, present, or reasonably foreseeable actions that
would aggregate with effects of the proposed action to affect livestock feed. Therefore, there are
no cumulative effects identified for this issue.
4.8 Socioeconomics
The CEQ and NEPA define effects on the human environment broadly to include economic and
social impacts in addition to physical impacts, although economic or social impacts, by
themselves, would not trigger the need for an Environmental Impact Statement (EIS) (40 CFR
1508.8, 1508.14).
4.8.1 Domestic Economic Environment
Domestic demand for corn in the U.S. comes from its domestic use for feed, ethanol production,
food, and seed, and totaled 11.1 billion bushels in the 2009/10 marketing year (USDA-ERS,
2011b). Exports added another 2 billion bushels to total U.S. corn use. Demand is satisfied
almost entirely by domestic supply, with few imports, the U.S. being largely a net exporter of
corn. The U.S. produced 13 billion bushels of corn in the 2009/10 marketing year and corn
occupied the most acreage of any crop in the country (USDA-ERS, 2011b). In the 2009/10
marketing year, feed was approximately 40 percent of U.S. corn production, ethanol production
was about 35 percent of U.S. corn use, food, seed, and industrial uses were approximately 45
percent, and exports the remaining 15 percent (USDA-ERS, 2011b). Seeds constituted
approximately 1.7 percent of domestic corn production, with 5.6 percent being used for high
fructose corn syrup, glucose and dextrose, and corn starch (USDA-ERS, 2010c).
58
Ethanol production from corn represented a much smaller share of demand before the Energy
Policy Act of 2005 established a 7.5-billion-gallon target for renewable fuels in gasoline by 2012
and a tax credit of 51 cents per gallon of ethanol blended with gasoline (Westcott, 2007). The
recent expansion in demand for corn for ethanol production is projected to slow, however,
reflecting moderate growth of gasoline consumption in the U.S. and limited potential for further
market penetration. The share of corn use for ethanol is expected to remain at 36 percent and the
share of exports to grow to 16 to 17 percent. Prices are projected to remain historically high.
According to the USDA, acreage is projected to increase to 92 million by 2020 from 88 million
in 2010, approximately a 4.5 percent increase, at the expense of other crop acreage (USDA-ERS,
2011b).
U.S. corn production benefits from various Federal programs, including crop insurance, counter-
cyclical payments, marketing loans, and the Average Crop Revenue Election program.
Additionally, ethanol imports are discouraged through an import tariff of 54 cents per gallon.
Corn is grown in all of the continental U.S., but more than 90 percent is grown in the top 18
producing states, mostly in the Midwest and Great Plains. The states with the most harvested
acres of corn for grains and silage in the 2007 Agricultural Census were Iowa, Illinois, Nebraska,
Minnesota, and Indiana (USDA, 2009).
Because MON 87460 is expected to reduce yield loss under water-limited conditions compared
to conventional corn, it would most likely be adopted in areas subject to frequent moderate water
deficit. It is also possible that irrigated corn-producing areas would benefit if adoption of MON
87460 would allow reduction of irrigation costs with net returns. These two conditions may be
found in Western drylands. Areas that currently do not produce corn are less likely to benefit
because they reveal fewer competitive advantages for corn production, although the possibility
of expansion of corn acreage has been assessed earlier.
Corn production requires a steady supply of moisture totaling approximately 20 inches during
the growing season to achieve maximum yields. Many U.S. states have average annual
precipitation below 20 inches per year. Among those states, those with most non-irrigated
acreage of corn harvested are North Dakota, Colorado, Montana, New Mexico, and Wyoming.
States with average annual precipitation between 20 and 30 inches per year could also benefit
from MON 87460, given variations in precipitation throughout the year and from one year to
another. Among those states, those with most non-irrigated acreage of corn harvested are
Minnesota, South Dakota, Nebraska, Kansas, and Texas (NOAA, 2010; USDA, 2009). States
with annual precipitation of more than 30 inches per year also could also benefit. However, the
increase in expected yields from adoption of MON 87460 would be less during times of higher
annual average precipitation and of lower variation of precipitation throughout the year (and in
between years). Therefore, there would be fewer incentives for adoption of MON 87460 in
states with higher average annual precipitation. Of the 10 states identified above, all except
Minnesota are in the Great Plains area of corn production, with Minnesota bordering this area in
the Midwest.
The states with the most irrigated acreage of corn harvested are Nebraska, Kansas, Texas,
Colorado, and California (USDA, 2009). Of these, all but California are in the Great Plains area
of corn production. In Texas and Colorado, the share of total irrigated crop acres (not just corn
59
acres) that had diminished yields due to irrigation interruption in 2008 was more than a quarter
of the total (USDA, 2008).
Most of this section focuses on the states where MON 87460 adoption would be expected to
result in more impacts on local yields and crop-related farm income. The geographic borders of
the analyzed region are a simplification intended to facilitate analysis and should not be
interpreted rigidly; some states included in this region have portions with considerably higher
annual average precipitation than others and portion of states not included in this regional focus
also might have corn production under non-irrigated areas routinely subject to water shortages.
In addition, climate change could impact areas of greater or lesser annual precipitation in the
future. This regional focus, however, is intended to emphasize the potential for regionally
differentiated impacts, noting that impacts on other corn-producing areas could be similar, but
arguably of a lesser degree.
There is no geographical difference in the U.S. among the areas of production of GE corn and
areas of production of organic and non-GE corn. Although the demand for different types of
corn depends on varietal traits that are often independent of the corn’s GE or non-GE quality,
there is a niche market for non-GE food and feed in the U.S., as evidenced by private labeling
initiatives (e.g., Non-GMO Project) that offer third-party product verification and labeling for
non-GMO products (Non-GMO-Project, 2010). There also is a growing niche market for
organic products in the U.S. Sales of organic products have been growing quickly, having grown
from $1 billion in 1990 to $24.8 billion in 2009 and 5.1 percent between 2008 and 2009 (OTA,
2010). To satisfy the demand for either organic or non-GE corn, producers have had to adopt
specific production practices that have been widely used in the U.S. for more than a decade.
However, in the case of organic corn production, there is some evidence that supply might be
lagging behind demand (Greene, et al., 2009).
Corn seed production in the U.S. follows standards of varietal purity. The AOSCA offers a
standard for production of non-GE corn seeds that allows for 1 percent presence of GE content
(AOSCA, 2003).
The affected domestic environment is defined as any land in the U.S. that is currently producing
crops that could incorporate a corn rotation, as well as land that could be converted from inactive
cropland to active cropland, and land currently in the CRP that could be removed from the
program and farmed. Within this affected environment, adoption of MON 87460 would be more
likely in some geographic areas than in others. Therefore, the domestic economic environment
most likely affected by deregulating MON 87460 would be the area of its adoption. To the
extent MON 87460 adoption allows for increased returns from corn production, MON 87460
deregulation could increase the supply of corn and corn-related farm income.
Because MON 87460 is expected to decrease yield loss in water-limited conditions, deregulation
of MON 87460 could impact total domestic corn production and corn acreage. Because it is a
GE crop, the potential for unintended presence in non-GE corn fields could impact marketing
non-GE and organic corn.
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4.8.1.1 No Action: Domestic Economic Environment
Under the No Action Alternative, any potential increase in corn production due to the decreased
yield loss under water-limited conditions offered by MON 87460
would not be realized.
It
should be noted that demand for U.S. corn is projected to remain strong due mostly to the
increases in global demand (exports) and the maintenance of incentives for use of ethanol.
4.8.1.2
Preferred Alternative
: Domestic Economic Environment
Varieties of Drought Tolerant Corn Available
Deregulating MON 87460 would allow the commercialization of a GE corn variety that is
expected to reduce yield loss by six percent or more under water-limited conditions compared to
conventional corn (Reeves, 2010). There appears to be two types of drought tolerant corn seed
available: the incrementally improving hybrids and some that are more advanced, which are just
making an appearance in the marketplace. Regionally marketed conventional traits apparently
have similar drought tolerant properties to those offered by MON 87460. To some extent, all
U.S. corn varieties have been becoming more drought resistant over time (Yu and Babcock,
2010), but others have been specially selected for drought tolerance. A current offering of seed
might include 22% of the options with a high drought tolerance rating (for maturities 79-119)
(DeKalb, 2011). Some companies currently offer corn seed that expresses exceptional drought
tolerant characteristics, which are generated without using transgenic techniques (e.g., Optimum
Aquamax, 5% yield advantage under water stress, limited availability in 2011 season) (Pioneer-
Hi-Bred, 2010, 2011a, 2011b). The impacts of deregulating MON 87460 would likely not be
different from these other existing seed options.
Analysis of Increases in Corn Acreage
Beyond increased expected yields in areas currently producing corn and subject to water-limited
conditions, an increase in corn acreage (without expansion necessarily to new agricultural areas)
is theoretically possible due to the increased expected returns to corn production. An estimate
depends on the expectations regarding rainfall, decreased yields in conventional corn during
water-limited conditions, decreased yield loss provided by MON 87460 during water-limited
conditions, the impact of yields on returns, the elasticity of corn acreage to increased returns, and
the extent of adoption of MON 87460. Because of uncertainties regarding each of these factors,
a reliable estimate is not possible. However, for illustrative purposes, a numerical exercise is
provided below for a hypothetical scenario. The variables assumed in this exercise should not be
considered to be those APHIS expects to actually occur, but rather reasonable assumptions,
given the illustrative purpose of this exercise and current available information.
Assumptions:
1. Yields of conventional varieties are expected to be 15 percent lower during water-
limited conditions, as the minimum assumed in the Monsanto variety trials (Reeves,
2010) (i.e., yield under water-limited conditions would be 85% of the yield under
adequate water conditions).
2. MON 87460 is expected to provide a 6 percent reduction in yield losses under those
circumstances (Reeves, 2010).
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3. Farmers perceived a 50 percent chance of water shortages (i.e., half the planted corn is
subjected to water-limited conditions and half is under adequate water conditions)
Expected yield returns in corn farming would increase as estimated below:
Expected yield with conventional variety = Yh × 0.5 + Yl × 0.5
= Yh x 0.5 + 0.85Yh × 0.5
= 1.85Yh × 0.5 = 0.925Yh
Expected yield with DT Corn = Yh × 0.5 + Yl x 1.06 × 0.5
= Yh × 0.5 + 0.85Yh x 1.06 × 0.5
= 1.901Yh × 0.5 = 0.9505Yh
Increased expected yield with DT Corn =
(Expected yield with DT corn- Expected yield with conventional variety)
(Expected yield with conventional variety)
= (0.9505Yh - 0.925Yh) ⁄ 0.925Yh
= (0.9505 - 0.925)Yh ⁄ 0.925Yh = 2.76%
Where:
Yh - yield under adequate water conditions; and
Yl - yield under water shortage (Yl = 0.85Yh).
Based on the above calculations, the expected yield increase using MON 87460 corn would be
2.76%. Based on USDA (USDA-ERS, 2010b) production cost and return estimates, a 2.76
percent increase in yields would translate to an approximate 5.5 percent increase in net returns
(i.e., from USDA data, yield/net returns = 0.5, then assuming the same ratio or 0.5 = (2.76)/(%
increase in net returns), a 2.76 percent increase in yields corresponds to 5.5 percent increase in
net returns). Available estimates of elasticity of corn acreage to expected returns are up to 0.48
for the U.S plains (FAPRI, 2004), suggesting a 5.5 percent increase in returns would translate to
a 2.6 percent increase in corn acreage (i.e., percent increase in corn acreage = 0.48 x 5.5 percent
increase in net returns) in those areas where returns from adoption of MON 87460 are expected
to increase. Taking non-irrigated harvest corn acreage from the 2007 Agricultural Census of the
10 previously mentioned states most likely to benefit from MON 87460 adoption as a basis, a 2.6
percent increase in corn acreage would result in 572 thousand acres of added corn fields (2.6
percent x 22 million acres), or approximately 0.65 percent of the current corn acreage in the U.S.
Because available estimates of the elasticity of agricultural land use to increased returns in
agriculture are very low (Barr et al., 2010), this increase in acreage would be almost entirely
observed on land converted from other crop production, rather than from land currently not in
62
agricultural use (including CRP land). Because the areas of corn expansion would be
presumably areas subject to yield loss under water shortages, a 0.65 percent increase in corn
acreage would likely have a less than proportional impact on corn production.
Again, the above numerical exercise should not be interpreted as an estimate, but rather as an
illustration of the magnitude of the potential impact, given the assumptions. If the number of
farms potentially benefiting from MON 87460 adoption is substantially larger, for example, the
impact on corn acreage also could be larger. However, given the magnitude of impacts
illustrated by the exercise above, the impact of MON 87460 deregulation on corn acreage is
expected to be minor.
Locations of Increased Farm Income
Corn-related farm incomes could increase in areas that adopt MON 87460. For example, using
the same hypothetical scenario described above and based on USDA (2010b) production cost
and return estimates, a possible 2.76 percent increase in yields would translate to an approximate
5.5 percent increase in net returns. The impact of such an increase in returns would be greater
for states where farms represent a greater share of state GDP and where corn represents a greater
share of crop acreage, such as Nebraska and South Dakota.
Impacts on Overall Farm Income
Increases in corn-related farm incomes would have a less than proportional impact on farm
household incomes because of the importance of other sources of income for corn-farm
households. An analysis of the USDA 2001 Agricultural Resource Management Survey
suggests that almost all the income of rural residence corn farmers and most of the income of
intermediate corn farmers (those with less than $250,000 in annual farm sales) was from off-
farm sources. Only on commercial corn farms (those with more than $250,000 in annual farm
sales) was crop-related farm income most of total income, a large share also being from direct
government payments. In all cases, corn-related income was a very small (typically negative)
share of the total income of corn-farm households (McBride, 2005). Based on this information,
impacts on overall farm income due to the deregulation of MON 87460 are expected to be
negligible.
Impacts on Irrigation and Water Use with MON 87460
Regarding the impact of MON 87460 on water use in irrigated corn, no data has been provided
or is available to assess the extent of savings in water costs that might be stimulated following
the adoption of MON 87460. Indeed, the observations presented in the petition indicate that
expected maximum yield in the variety depends on attaining sufficient water (Reeves, 2010).
MON 87460 would be used to provide a safeguard against unexpected interruptions in water for
irrigation, but would certainly be used by growers if reductions in irrigation proven possible or
that MON87460 was otherwise useful in some circumstances to reduce use of irrigation water.
At present, irrigation sparing capacity of MON 87460 has not been demonstrated, and
expectations for savings on irrigation are not consistent with current experimental observations
provided by the applicant (Reeves, 2010).
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Additional Impacts
The greatest impact of the product will likely be that growers experience yield losses with MON
87460 that are less than those incurred by planting non-drought tolerant corn varieties. Another
possible impact is the possible reduction of crop insurance costs, since better potential yield in
drought could be purchased by growers especially if growing MON 87460 might be specifically
stipulated by an insurance contract (as for example, a “Biotech Yield Endorsement” that is
offered by insurance providers (Iowa State, 2007)). An increase in land values as a result of
planting MON 87460 is also possible, although there is not enough information to assess these
potential impacts.
Impacts on Organic and non-GE Corn Producers by MON 87460
Non-GE, organic, and GE corn are currently grown in generally the same areas. Although the
unintended presence of GE content in organic farming does not necessarily lead to the loss of
organic certification, a cost to both organic and non-GE corn farmers may include testing for the
presence of GE material that is required by some discriminating buyers. However, there is no
reason to believe that gene flow from MON 87460 would be any more likely than gene flow
from currently available GE varieties for reasons previously described. To the extent
deregulation of MON 87460 would contribute to increased GE corn acreage, the likelihood of
proximity of organic and non-GE corn farmers to GE corn could potentially increase as well.
However, as previously analyzed, current projections for increases in corn acreage under the No
Action Alternative are about 4.5 percent between 2009 and 2020. As demonstrated by the
numerical exercise above, the magnitude of impact of MON 87460 deregulation on corn acreage
could be substantially less than that of other current factors that encourage planting of other GE
varieties and for them to affect increases in corn acreage.
An estimate of the increase in corn production would depend on the degree of adoption, on the
actual impact of MON 87460 to yields under water-limited conditions, and the degree of water
shortage in any given year. The overall impact of MON 87460 deregulation on U.S. corn
production is expected to be minor.
4.8.1.3 Cumulative Effects: Domestic Economic Environment
Through tax incentives and import tariffs and a federal mandate to increase the use of renewable
fuels in gasoline, government policy has stimulated the growth of corn production for use in the
production of ethanol. These policies are expected to continue in the foreseeable future and add
to the incentive for corn production that would follow MON 87460 deregulation.
Corn acreage is expected to increase, but conversion of CRP acreage to new corn acres is not
expected to increase. The 2008 Farm Bill reduced the maximum acreage allowed in the CRP to
32 million, 2.6 million acres below the 2008 enrollment (Farm Bill, 2008). To the extent that
some of this land is converted to agricultural use, existing corn acreage could increase and add to
the incentive for corn production. The conversion of CRP acres would be independent of
adoption of MON 87460 corn.
Other Federal policies such as Federal crop insurance, marketing loans, direct and counter-
cyclical payments, and the Average Crop Revenue Election (ACRE) program may influence
64
decisions of planting corn (as opposed to other crops or as opposed to non-agricultural uses of
land) and add to the incentive for corn production that would follow MON 87460 deregulation.
4.8.2 Trade Economic Environment
The U.S. is the largest world exporter of corn. This section describes potential impacts on U.S.
trade flows from deregulating of MON 87460.
In the 2008/9 marketing year, corn exports accounted for approximately 15 percent of the total
U.S. corn use behind feed, ethanol production, and food and seed (USDA-ERS, 2011b). Because
exports are a relatively small share of U.S. corn use but the U.S. is the largest exporter of corn,
U.S. domestic markets have a large influence on international corn prices (USDA ERS 2009b).
In 2009, total exports of corn valued approximately $9 billion, with less than 2.5 percent of this
being for seed. The primary countries of destination for U.S. corn exports in 2009 were Japan,
Mexico, South Korea, Taiwan, Canada, and Egypt, with more than 75 percent of the total
(USDA-FAS, 2010a). The primary seed export destinations are Canada and Mexico.
The U.S. is by far a net exporter of corn with imports in 2009 valued less than $300 million,
almost 90 percent of this coming from Chile, Argentina, and Canada (USDA FAS 2010a, code
1005 of the Harmonized System).
About 60 percent of the world trade in coarse grains (corn, barley, sorghum, rye, oats, millet, and
mixed grains) is for feed and 75 percent of the coarse grains trade is corn. Trade in feed for
livestock has been a driver of trade in corn (USDA-ERS, 2011b). Japan is the world’s largest
corn importer, typically followed by South Korea, Mexico, Egypt, and Taiwan (USDA-FAS,
2010b). Between the trade years (October through September) of 2003/4 through 2007/8, the
U.S. share of world corn exports averaged 60 percent, the second largest exporter being
Argentina, with China’s exports being occasionally important yet unpredictable, and largely a
function of internal policies(USDA, 2009).
The primary U.S. corn export destinations are also the largest world importers of corn and do not
seem to have major barriers for importing GE products. In Japan there are no restrictions for
import of genetically engineered varieties that have been approved for commercialization in
Japan. In the case of genetically engineered varieties not yet approved in Japan a 1 percent
presence in feed is still allowed, as long as it has been approved by an exporting country with
safety assessments equivalent to Japan’s. There is no restriction after approval. Labeling is
mandatory for GE food when the GE content can be detected and if the GE ingredient is one of
the first three ingredients of a product and accounts for more than 5 percent of its total weight
(Greuere, 2006). Mexico imports and consumes regularly existing varieties of GE corn (USDA-
FAS, 2008b). South Korea has similar approval processes as Japan and requires labeling for GE
animal feed (USDA-FAS, 2008). Taiwan requires labeling for products containing more than 5
percent GE content (USDA-FAS, 2008c). Egypt is a large consumer of GE crops, including
corn, soybeans, and vegetable oils (USDA-FAS, 2006).
While detailed data are not readily available for U.S. organic crop exports, the USDA Foreign
Agricultural Service estimates that exports of all organic products in 2009 totaled $1.7 billion
(USDA-ERS, 2011a; USDA-FAS, 2011). Official U.S. data are currently limited by the lack of
international trade codes for organic products; thus far, only Canada and the U.S. have
65
established trade codes for organic products (USDA-FAS, 2011). However, given the large
demand for non-organic grain corn on the international market, it is likely that U.S. organic trade
is a small contributor to total corn trade.
The affected trade economic is defined as those countries with which the U.S. engages in corn
feed, seed and food trade. Therefore, the trade economic environment most likely affected by
deregulating MON 87460 would be those countries who import MON 87460 feed, seed, and
food.
4.8.2.1 No Action: Trade Economic Environment
The USDA provides projections for the agricultural sector through 2020 (USDA-ERS, 2011b).
World trade in corn is projected to increase 30 percent between the 2008/9 trade year and the
2019/20 trade year. The U.S. share of that trade is projected to remain slightly below 60 percent,
with U.S. corn exports therefore increasing at a rate also close to 30 percent. Although, many
countries are investing in biofuel production capacity, several feedstocks are used in addition to
corn, such as sugarcane for ethanol and rapeseed and soybean oil for biodiesel. Feed for
livestock is projected to remain the main driver of corn trade.
Under the No Action Alternative, any potential increase in corn seed exports with deregulation
of MON 87460 in the U.S. would not be realized.
4.8.2.2 Preferred Alternative: Trade Economic Environment
Although the primary U.S. corn export destinations do not present major barriers to trade in GE
products, Monsanto would need to obtain MON 87460 approval in destination countries before
commercialization to avoid adversely affecting current trade flows. Monsanto recognizes this in
its petition and states its intention to seek approval for MON 87460 in primary U.S. export
destinations with functioning regulatory systems before commercialization in the U.S. (Reeves,
2010). Requests for approvals have been submitted to several markets, and Canada had approved
the product for food, feed and cultivation, and Australia and New Zealand have approved it for
food use.
MON 87460 seed could be of particular interest to parts of the world where corn production
suffers from water-limited conditions. To the extent this interest translates to demand for U.S.
MON 87460 seed as a result of the deregulation of MON 87460, there could be a potential for
increased corn seed exports. Because corn seed exports are a small share of total U.S. corn
exports, this impact is expected to be minor or negligible. Corn from this foreign production
could potentially enhance production in drought stressed locations in other countries.
4.8.2.3 Cumulative Effects: Trade Economic Environment
APHIS identified a potential minor or negligible impact to trade economic environment as a
result of the Preferred Alternative, which could contribute to a cumulative impact by another
foreseeable action. MON 87460 seed may be marketed abroad, potentially stacked with existing
corn germplasm that exhibits similar traits; depending upon how much increase in corn
production the variety may encourage, there may be incremental changes to foreign corn
production.
MON 87460
could have impacts of unknown size on U.S. trade following MON
87460 deregulation in the U.S and abroad. Currently, requests for approvals for all purposes
66
including planting have been submitted to Mexico and Canada but only Canada has approved the
product for cultivation so far.
4.9 International Impacts Analysis
4.9.1 Transboundary Impacts
The CEQ guidance on NEPA analyses for transboundary impacts (CEQ 1997) requires Federal
officials to consider reasonably foreseeable transboundary effects in the environmental analysis
of proposed actions occurring in the U.S. Potential transboundary impacts on Mexico and
Canada are addressed below.
As discussed in the Animal and Plant Communities Affected Environment section, APHIS
evaluated the potential for gene flow to occur from MON 87460 to sexually compatible wild
relatives. As stated previously, cultivated corn is sexually compatible with its closest relative,
teosinte, and with members of the genus
Tripsacum
, although to a much lesser degree
(Mangelsdorf, 1974; OECD, 2003; Wilkes, 1967). Corn and teosinte are genetically
compatible, wind-pollinated, and can hybridize when close to each other, but hybridization
would only be likely to occur in Mexico and Guatemala because teosinte is not present in the
U.S., except for a few small feral populations of
Zea mexicana
in Alabama, Florida, Maryland
(USDA-NRCS, 2010), and
Zea perennis
in South Carolina (USDA-NRCS, 2011).
Tripsacum
species have one less chromosome than corn but can hybridize with corn, although it is very
difficult and requires special techniques, and the hybrids have a high degree of sterility and are
genetically unstable (Mangelsdorf, 1974). Crosses between corn and
Tripsacum dactyloides
can be made, but only through human intervention and, even then, it is extremely difficult
(CFIA, 1994).
MON 87460 is not likely to hybridize with sexually compatible species in the United States
because of differences in factors such as flowering time, geographical separation, and
development factors (Doebley, 1990a, 1990b; Ellstrand, et al., 2007; Galinat, 1988). Further,
Tripsacum dactyloides
and
Tripsacum floridanum
would not be affected by MON 87460
because of the difficulty of hybridizing with these species. The potential impact of gene flow
into teosinte is not expected to be any different than that of other currently available cultivated
corn varieties. Based on these considerations, and in particular geographic separation,
APHIS
anticipates no potential direct, indirect or cumulative transboundary gene flow impacts into
teosinte found in Mexico.
No known sexually compatible species were identified in Canada, and APHIS has identified no
potential direct, indirect or cumulative transboundary gene flow impacts in relation to Canada
following from the deregulation of MON 87460.
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5 THREATENED AND ENDANGERED SPECIES
The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching
wildlife conservation laws ever enacted by any nation. Congress, on behalf of the American
people, passed the ESA to prevent extinctions facing many species of fish, wildlife and plants.
The purpose of the ESA is to conserve endangered and threatened species and the ecosystems on
which they depend as key components of America’s heritage. To implement the ESA, the U.S.
Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries
Service (NMFS), other Federal, State, and local agencies, Tribes, non-governmental
organizations, and private citizens. Before a plant or animal species can receive the protection
provided by the ESA, it must first be added to the Federal list of threatened and endangered
wildlife and plants.
A species is added to the list when it is determined by the USFWS/NMFS to be endangered or
threatened because of any of the following factors:
The present or threatened destruction, modification, or curtailment of its habitat or
range;
Overutilization for commercial, recreational, scientific, or educational purposes;
Disease or predation;
The inadequacy of existing regulatory mechanisms; and
The natural or manmade factors affecting its survival.
Once an animal or plant is added to the list, in accordance with the ESA, protective measures
apply to the species and its habitat. These measures include protection from adverse effects of
Federal activities.
Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or
the NMFS, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the
continued existence of a listed species or result in the destruction or adverse modification of
designated critical habitat. It is the responsibility of the Federal agency taking the action to
assess the effects of their action and to consult with the USFWS and NMFS if it is determined
that the action “may affect” listed species or critical habitat. This process is used by APHIS to
assist the program in fulfilling their obligations and responsibilities under Section 7 of the ESA
for biotechnology regulatory actions.
As part the environmental review process, APHIS thoroughly reviews GE product information
and data to inform the ESA effects analysis and, if necessary, the biological assessment. For
each transgene(s)/transgenic plant the following information, data, and questions are considered
by APHIS:
A review of the biology, taxonomy, and weediness potential of the crop plant and its
sexually compatible relatives;
Characterization of each transgene with respect to its structure and function and the
nature of the organism from which it was obtained;
68
A determination of where the new transgene and its products (if any) are produced in
the plant and their quantity;
A review of the agronomic performance of the plant including disease and pest
susceptibilities, weediness potential, and agronomic and environmental impact;
Determination of the concentrations of known plant toxicants (if any are known in the
plant); and
Analysis to determine if the transgenic plant is sexually compatible with any
threatened or endangered plant species (TES) or a host of any TES.
APHIS analyzed the potential for effects from cultivation of MON 87460 on Federally listed TES
and species proposed for listing, as well as designated critical habitat and habitat proposed for
designation, as required under Section 7 of the ESA. Direct effects are analyzed by considering
the response that TES could have if exposed to MON 87460. Indirect effects are those that
could result from the use of MON 87460 in corn production, would occur later in time, but are
still reasonably certain to occur. Consideration is given for the potential of MON 87460 to
change the baseline habitat of TES including critical habitat.
MON 87460 will be grown on agricultural acres managed by growers in a manner similar to
conventionally bred corn.
MON 87460 is not genetically engineered to produce a toxin or
pesticide, and is not genetically engineered to be tolerant to an herbicide.
Corn is an annual,
wind-pollinated crop which lacks sexually compatible wild relatives (including threatened or
endangered plant species) in the U.S., except for an occasional botanical garden specimen or
small feral populations of Zea mexicana in Florida, Alabama and Maryland or Zea perennis in
South Carolina (http://plants.usda.gov).
Because corn itself is not sexually compatible with any
listed plant species, there is no potential for a direct effect of
MON 87460
on TES plants.
Because corn cannot naturalize and would not affect pollinators, there are no expected
indirect effects of
MON 87460
on TES plants.
Corn exhibits extremely limited seed dormancy, has no weedy characteristics, and volunteers are
easily controlled. It is not capable of establishing persistent populations in unmanaged
environments. As discussed previously, the presence of the CSPB protein in no way alters the
weediness potential or gene flow potential of MON 87460. Therefore, it is highly unlikely that
MON 87460 poses any more of a risk to threatened or endangered plant species than
conventionally bred corn.
Corn is a feed commonly provided to many livestock and consumed by wildlife (e.g., birds,
deer, and rodents). The data presented in the petition suggests there is no difference in
compositional and nutritional quality of
MON 87460
compared to conventional corn, apart
from the presence of the
CSPB and NPTII proteins
.
Based on the nature of the proteins, their
known activity, and the characteristics of the donor organisms, the CSPB and NPTII proteins
have a history of safety to organisms exposed at levels found in MON 87460.
Because there is
no toxicity or allergenicity potential with
MON 87460
, there would be no direct or indirect
toxicity or allergenicity impacts on wildlife species that feed on corn or the associated biological
food chain of organisms. A consultation with FDA was successfully completed for
CSPB and
NPTII proteins of MON 87460
(Appendix A), which demonstrated a lack of toxicity and
69
allergenicity of
MON 87460
for human and animal consumption. Therefore, it is unlikely that
MON 87460
would affect
threatened and endangered
animal species, including animals such
as insects, bats or birds that may be pollinators of TES plants.
APHIS has considered whether approval of MON 87460 will result in additional lands being
converted to corn acreage, and consequently have possible impacts on T&E species.
APHIS
evaluates that corn acreage may well increase through 2020, but much of the land used will be
at the expense of acreage planted to other crops on existing agricultural lands.
Another source
of additional lands are those in federal set aside programs, such as the Conservation Reserve
Program. This program safeguards environmentally sensitive lands by planting native plants or
long-term, resource-conserving cover crops that would control soil erosion, improve water and
air quality, and enhance wildlife habitat. By taking land out of production under long term
contracts, growers are given annual rental payments and cost-share assistance to promote these
federal and state goals.
The native and introduced vegetation provides habitat to wildlife, most
notably birds (Delisle and Savidge, 1997; McCoy et al., 2001). Animals, including threatened
and endangered species that could be affected by conversion of CRP land to
MON 87460
production, use CRP land for food or cover. The animals that could be present in CRP areas
would vary depending on the region and type of habitat. APHIS has concluded that although
corn acreage could increase through 2020, no net increase in conversion of CRP lands for the
reduced yield loss corn will likely occur. Some acreage may move in and out of CRP lands, but
overall, APHIS has evaluated in this EA that neither this crop nor other corn crops will directly
contribute to large-scale conversion of these reserved lands to agricultural lands.
MON 87460 is a corn variety that may reduce yield loss from drought, and displays no
agronomic characteristics substantially different from existing commercial corn, and therefore is
not weedy, nor likely to contribute to weediness of corn. Aside from expression of a common
bacterial protein, no differences have been shown from similar corn varieties. Because no traits
of MON 87460 corn have been shown to be different from commodity corn, it is highly unlikely
that MON 87460 will have impacts different from other commodity corn varieties. Neither are
impacts likely when MON 87460 corn is combined through traditional breeding methods with
APHIS- or EPA-approved insect-protected or herbicide tolerant traits. No direct or indirect
adverse impacts were identified that would result from producing this corn, and APHIS
concluded that there were also no cumulative impacts on any resources in agricultural or non-
agricultural environment.
After reviewing possible effects of a
determination of
nonregulated status of MON 87460 corn,
APHIS has not identified any stressor that could affect the reproduction, numbers, or
distribution of a listed TES or species proposed for listing. As a result, a detailed exposure
analysis for individual species is not necessary.
APHIS has considered the effect of MON 87460 production on designated critical habitat or
habitat proposed for designation and could identify no difference from effects that would occur
from the production of other corn varieties. Additionally, cornfields are not designated critical
habitat for any Federally threatened and endangered animal species listed under the ESA
(USFWS 2010). As discussed, APHIS has concluded that the deregulation of this MON 87460
corn is unlikely to lead to large scale conversion of CRP land and consequent significant
impacts on some CRP land that could become agricultural.
70
Based on the above information, APHIS has concluded that
a determination of nonregulated
status of MON 87460
would have no effect on Federally listed threatened or endangered
species or species proposed for listing, nor would it affect designated critical habitat or habitat
proposed for designation. Consequently, consultation with the USFWS or NMFS is not
required for this action.
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6
CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES
RELATING TO
ENVIRONMENTAL IMPACTS
6.1.1
Executive Orders with Domestic Implications
The following executive orders require consideration of the potential impacts of the federal
action to various segments of the population.
Executive Order (EO) 12898 (US-NARA, 2010), "Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income Populations,"
requires Federal agencies to conduct their programs, policies, and activities that
substantially affect human health or the environment in a manner so as not to exclude
persons and populations from participation in or benefiting from such programs. It
also enforces existing statutes to prevent minority and low-income communities from
being subjected to disproportionately high and adverse human health or
environmental effects.
CEQ guidance for implementation of EO 12898 in the context of NEPA (Environmental Justice.
Guidance Under the National Environmental Policy Act, December 10, 1997) identifies a
minority population as an affected area where over 50 percent of the population belongs to a
minority group or where the percentage presence of minority groups is meaningfully greater than
in the general population. Geographically disperse groups with common conditions of
environmental exposure may also be considered as a community subject to analysis for
percentage presence of minority groups (e.g. agricultural workers).
Table 8 shows minority presence in the U.S. and in the states where MON 87460 would likely be
adopted to reduce the potential yield loss from water shortages. African Americans are
represented in Texas at 11.4%, the highest percentage of all the affected states, while Hispanic
Americans are represented at the highest in New Mexico at 44.9% and Texas at 36.5%. Although
in New Mexico and Texas minorities are more than 50 percent of the population, in the ten states
as a whole, minorities constitute only a slightly higher share of the total population than in the
U.S. In all ten analyzed states, Hispanics and Native Americans are the minority groups whose
presence surpasses their presence in the country as a whole: in both cases, their share in the ten
analyzed states is approximately 1.7 times their share in the U.S.
Table 8. Minority populations in states where MON 87460 may be adopted, 2008.
Location
Total
Population
Percent of Total Population
White
Black or
African
American
Alaska
Native or
American
Indian Asian
Native
Hawaiian
& Other
Pacific
Islander
Some
Other
Race
Two
or
More
Races
Hispanic
or
Latino
a
Total
Minorities
b
U.S. 304,059,728 75.05% 12.36% 0.80% 4.41% 0.14% 4.93% 2.31% 15.42% 34.57%
Colorado 4,939,456 84.74% 3.80% 0.97% 2.55% 0.11% 4.75% 3.08% 20.19% 29.22%
Kansas 2,802,134 86.25% 5.62% 0.73% 2.14% 0.07% 2.48% 2.70% 9.08% 19.78%
Minnesota 5,220,393 88.14% 4.42% 1.05% 3.52% 0.01% 1.07% 1.80% 4.13% 14.69%
Montana 967,440 89.62% 0.54% 6.05% 0.67% 0.07% 0.64% 2.41% 2.82% 12.14%
72
Table 8. Minority populations in states where MON 87460 may be adopted, 2008.
Location
Total
Population
Percent of Total Population
White
Black or
African
American
Alaska
Native or
American
Indian Asian
Native
Hawaiian
& Other
Pacific
Islander
Some
Other
Race
Two
or
More
Races
Hispanic
or
Latino
a
Total
Minorities
b
Nebraska 1,783,432 88.91% 3.99% 0.76% 1.50% 0.05% 2.61% 2.18% 7.84% 15.82%
New Mexico 1,984,356 73.45% 2.28% 9.22% 1.35% 0.04% 10.48% 3.19% 44.90% 58.45%
North Dakota 641,481 91.00% 0.95% 5.30% 0.84% 0.04% 0.56% 1.30% 2.02% 10.21%
South Dakota 804,194 87.10% 0.94% 8.17% 0.82% 0.03% 0.77% 2.17% 2.36% 13.96%
Texas 24,326,974 73.87% 11.43% 0.50% 3.46% 0.08% 8.71% 1.95% 36.46% 52.78%
Wyoming 532,668 91.87% 1.06% 2.04% 0.70% 0.03% 1.52% 2.77% 7.73% 13.34%
Total of
10 States
44,002,528 79.22% 7.95% 1.39% 2.92% 0.07% 6.27% 2.19% 26.06% 39.57%
Source: U.S. Census Bureau, American Community Survey 2008 (USCB 2008).
a
Individuals who identify themselves as Hispanic, Latino, or Spanish might be of any race; the sum of the other percentages under
the “Percent of Total Population” columns plus the “Hispanic or Latino” column therefore does not equal 100 percent.
b
The total minority population, for the purposes of this analysis, is the total population minus the non-Latino/Spanish/Hispanic
white population.
Table 9: Minority farmer populations in states where MON 87460 may be
adopted, 2007.
Location
T
otal farme
r
population
Hispanic or
Latino
Percent of
Total
Alaska Native or
American Indian
Percent of
Total
U.S. 3,337,450 82,462 2.47% 55,889 1. 7%
Colorado 60,684 2,610 4.30% 619 1.0%
Kansas 97,150 780 0.80% 508 0.5%
Minnesota 119,650 507 0.42% 413 0.4%
Montana 46,903 345 0.74% 2,013 4.4%
Nebraska 71,924 288 0.40% 63 0.1%
New Mexico 32,109 8,904 27.73% 6,611 21.2%
North Dakota 45,114 142 0.31% 503 1.1%
South Dakota 46,710 196 0.42% 1,150 2.5%
Texas 372,563 28,921 7.76% 3,604 1.0%
Wyoming 18,522 256 1.38% 324 1.8%
Total of 10 States 911,329 42,949 4.71% 15,808 1.7%
Source: 2007 Census of Agriculture – State Data (USDA-NASS 2007b)
To the extent that impacts of MON 87460 deregulation affect primarily farm households, Table 9
shows the presence of Hispanics and American Indians among farm operators (those who run the
farm: owners or other). The highest percentage of Hispanic farmers is found in New Mexico at
27.7% and in Texas at 7.8% and the highest percentage of American Indian farmers is in New
Mexico at 20.6% (Table 9). Although Hispanic operators are considerably more highly
73
represented in the ten state region than in the country as a whole (1.9 times more), both
Hispanics and American Indian operators comprise a much smaller share of farm operators than
they are of the total population in the 10-state region: 4.7 percent of operators are Hispanics and
1.7 percent are American Indian.
A large percentage of agricultural workers in the U.S. are born in Mexico 75 percent in the
2001/02 fiscal year (USDOL-(United-States-Department-of-Labor), 2005). A relatively small
share, 14 percent, of all agricultural workers had a field crop as their primary crop in 2001/02,
most agricultural workers being employed in fruit, vegetable, and horticultural crops (USDOL-
(United-States-Department-of-Labor), 2005). However, any impacts on agricultural workers
would likely affect a considerably larger share of Hispanics than the share of Hispanics in the
total population.
CEQ guidance for implementation of EO 12898 in the context of NEPA (Environmental Justice.
Guidance Under the National Environmental Policy Act, December 10, 1997) suggests an
analysis based upon U.S. Census Bureau Current Population Reports, Series P-60 on Income and
Poverty for identification of low-income populations. This data is derived from the American
Community Survey done annually through a representative household sample. Table 10, below,
shows that the share of population in poverty in the ten state region is only slightly higher than
the share of the population in poverty in the country as a whole.
Table 10: Low-income presence, 2008.
Location Total
a
Low-Income
Low-Income
Share of Total
U.S. 296,184,480 39,108,422 13.20%
Colorado 4,835,406 552,889 11.43%
Kansas 2,716,652 307,478 11.32%
Minnesota 5,090,468 490,911 9.64%
Montana 942,874 139,707 14.82%
Nebraska 1,727,276 186,727 10.81%
New Mexico 1,941,428 332,769 17.14%
North Dakota 615,412 73,622 11.96%
South Dakota 774,737 96,490 12.45%
Texas 23,727,821 3,760,431 15.85%
Wyoming 518,368 48,776 9.41%
Total of 10 States 42,890,442 5,989,800 13.97%
Source: U.S. Census Bureau, American Community Survey 2008 (UCSB 2008).
a
Universe is population for whom poverty status is determined
With respect to farm households, in 2003, 11 percent of the U.S. population was below the U.S.
Census Bureau poverty line, while 14 percent of farm households were poor. Offutt and
Gundersen (2005) argue that the U.S. Census Bureau poverty line might not adequately capture
poverty in farm households, given that it does not capture the volatility of farm income and the
greater asset holdings of farm households. Under the USDA alternative concept of Limited
Resource Farmer, 11 percent of farm households would fall under that category in 2003, while
74
under the USDA ERS Low Income/Low Wealth concept, only 5 percent of farm households
would be classified as such in that same year.
The possibility of disproportionately high and adverse human health and environmental effects
depends on the existence in the affected area of minority or low-income populations and on the
existence of significant impacts of a proposed alternative. If, for example, differential patterns of
consumption of water or subsistence consumption of indigenous fish, vegetation, or wildlife are
important to minority populations, low-income populations, or Indian tribes in the affected area,
and some adverse impact existed on these resources, then these differential patterns of
consumption could also lead to disproportionately high and adverse impacts.
Each alternative was analyzed with respect to EO 12898. Neither alternative is expected to have
a disproportionate adverse effect on minorities or low-income populations. As presented in the
Environmental Consequences section, no significant impacts were identified in the analyses
conducted on human health, physical environment, or animal and plant communities.
MON 87460
has been shown to be no difference in compositional and nutritional quality
compared to conventional corn, apart from the presence of the
CSPB and NPTII proteins.
The inserted genes (cspB and nptII) and proteins (CSPB and NPTII) expressed in MON 87460
are not expected to be allergenic, toxic, or pathogenic in mammals. Both CSBP and NPII
proteins have a history of safe consumption in the context of other food and feeds (FDA, 2010).
This information establishes the safety of MON 87460 and its products to humans, including
minorities and low income populations who might be exposed to them through agricultural
production and/or processing. No additional safety precautions would need to be taken.
None of the impacts on agricultural practices expected to be associated with deregulation of
MON 87460 are expected to have a disproportionate adverse effect on minorities and low
income populations.
MON 87460 is not genetically engineered to produce a toxin or
pesticide, and is not genetically engineered to be tolerant to a herbicide. D
ue to the lack of
pesticidal and herbicidal traits in MON 87460, corn hybrid varieties may be produced with MON
87460 and other nonregulated corn hybrids containing herbicide tolerant and/or pesticide traits.
Thus, pesticide application practices and usage associated with deregulation of MON 87460 are
not expected to change from the current trends for existing nonregulated GE corn.
EO 13045, “Protection of Children from Environmental Health Risks and Safety
Risks,” acknowledges that children may suffer disproportionately from
environmental health and safety risks because of their developmental stage, greater
metabolic activity levels, and behavior patterns, as compared to adults. The EO (to
the extent permitted by law and consistent with the agency’s mission) requires each
Federal agency to identify, assess, and address environmental health risks and safety
risks that may disproportionately affect children.
Each alternative was analyzed with respect to EO 13045. Neither alternative is expected to have
a disproportionate adverse effect on children. As presented in the Environmental Consequences
section, no significant impacts were identified in the analyses conducted on human health or the
physical environment.
75
MON 87460
has been shown to be no difference in compositional and nutritional quality
compared to conventional corn, apart from the presence of the
CSPB and NPTII proteins.
The inserted genes (cspB and nptII) and proteins (CSPB and NPTII) expressed in MON 87460
are not expected to be allergenic, toxic, or pathogenic in mammals. Both CSBP and NPII
proteins have a history of safe consumption in the context of other food and feeds (FDA, 2010).
This information establishes the safety of MON 87460 and its products to humans, including
children who might be exposed to them through agricultural production and/or processing. No
additional safety precautions would need to be taken.
None of the impacts on agricultural practices expected to be associated with deregulation of
MON 87460 are expected to have a disproportionate adverse effect on children.
MON 87460 is
not genetically engineered to produce a toxin or pesticide, and is not genetically engineered
to be tolerant to a herbicide. D
ue to the lack of pesticidal and herbicidal traits in MON 87460,
corn hybrid varieties may be produced with MON 87460 and other nonregulated corn hybrids
containing herbicide tolerant and/or pesticide traits. Thus, pesticide application practices and
usage associated with deregulation of MON 87460 are not expected to change from the current
trends for existing nonregulated GE corn.
The following executive order addresses Federal responsibilities regarding the introduction and
effects of invasive species:
EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal agencies take
action to prevent the introduction of invasive species, to provide for their control,
and to minimize the economic, ecological, and human health impacts that
invasive species cause.
All corn varieties, including
MON 87460
, require human assistance to persist beyond a first
generation of corn plants that may arise from spilled seed; they do not establish self-propagating
populations. Corn does not possess traits that are characteristic of invasive species (Baker 1965,
Keeler 1989, Galinat 1988).
The following executive order requires the protection of migratory bird populations:
EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agencies to Protect
Migratory Birds,”
states that federal agencies taking actions that have, or are
likely to have, a measurable negative effect on migratory bird populations are
directed to develop and implement, within two years, a Memorandum of
Understanding (MOU) with the Fish and Wildlife Service that shall promote the
conservation of migratory bird populations.
Data submitted by the applicant has shown no difference in compositional and nutritional
quality of
MON 87460
compared with other GE corn or non-GE corn, apart from the presence of
the
CSPB and NPTII proteins
. MON 87460
not expected to be allergenic, toxic, or pathogenic
in mammals. Both CSBP and NPII proteins have a history of safe consumption in the context of
other food and feeds (FDA, 2010). Additionally, the FDA has completed its food safety
consultation on MON 87460.
Based on APHIS’ assessment of
MON 87460,
it is unlikely that a
determination of
nonregulated status of MON 87460 will have a negative effect on migratory bird
populations.
76
6.1.2 International Implications
EO 12114 (US-NARA, 2010), “Environmental Effects Abroad of Major Federal Actions”
requires federal officials to take into consideration any potential environmental effects outside
the U.S., its territories, and possessions that result from actions being taken.
APHIS has given this EO careful consideration and does not expect a significant environmental
impact outside the U.S. in the event of a determination of nonregulated status of MON 87460.
All existing national and international regulatory authorities, and phytosanitary regimes that
currently apply to introductions of new corn cultivars internationally apply equally to those
covered by an APHIS determination of nonregulated status under 7 CFR Part 340.
Any international trade of MON 87460 subsequent to a determination of nonregulated status of
the product would be fully subject to national phytosanitary requirements and be in accordance
with phytosanitary standards developed under the International Plant Protection Convention
(IPPC, 2010).
The purpose of the IPPC “is to secure a common and effective action to
prevent the spread and introduction of pests of plants and plant products and to promote
appropriate measures for their control” (IPPC, 2010). The protection it affords extends to natural
flora and plant products and includes both direct and indirect damage by pests, including
weeds.
The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification
among the nations that have signed or acceded to the Convention (172 countries as of March
2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at
a meeting of the governing body of the IPPC as a supplement to an existing standard,
International Standard for Phytosanitary Measure No. 11 (ISPM-11, Pest Risk Analysis for
Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a
determination needs to be made early in the PRA for importation as to whether the LMO
poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment
procedures for genetically engineered organisms are consistent with the guidance developed
under the IPPC. In addition, issues that may relate to commercialization and transboundary
movement of particular agricultural commodities produced through biotechnology are being
addressed in other international forums and through national regulations.
The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on
Biological Diversity (CBD) that established a framework for the safe transboundary movement,
with respect to the environment and biodiversity, of LMOs, which include those modified
through biotechnology. The Protocol came into force on September 11, 2003, and 160 countries
are Parties to it as of December 2010 (CBD, 2010). Although the U.S. is not a party to the CBD,
and thus not a party to the Cartagena Protocol on Biosafety, U.S. exporters will still need to
comply with those regulations that importing countries which are Parties to the Protocol have
promulgated to comply with their obligations. The first intentional transboundary movement of
LMOs intended for environmental release (field trials or commercial planting) will require consent
from the importing country under an advanced informed agreement (AIA) provision, which
includes a requirement for a risk assessment consistent with Annex III of the Protocol and the
required documentation.
77
LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and
are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post
decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may
be subject to transboundary movement. To facilitate compliance with obligations to this
protocol, the U.S. Government has developed a website that provides the status of all
regulatory reviews completed for different uses of bioengineered products (NBII, 2010). These
data will be available to the Biosafety Clearinghouse.
APHIS continues to work toward harmonization of biosafety and biotechnology consensus
documents, guidelines, and regulations, including within the North American Plant Protection
Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the
Organization for Economic Cooperation and Development (OECD). NAPPO has completed
three modules of the Regional Standards for Phytosanitary Measures (RSPM) No. 14,
Importation and Release into the Environment of Transgenic Plants in NAPPO Member
Countries
(NAPPO, 2009).
APHIS also participates in the
North American Biotechnology Initiative (NABI)
, a forum for
information exchange and cooperation on agricultural biotechnology issues for the U.S.,
Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are
held regularly with other countries including Argentina, Brazil, Japan, China, and Korea.
6.1.3 Compliance with Clean Water Act and Clean Air Act
This EA evaluated the changes in corn production due to the unrestricted use of
MON 87460
.
Cultivation of
MON 87460
is not expected to lead to the increased production of corn in U.S.
agriculture.
There is no expected change in water use and quality due to the cultivation of
MON 87460
compared with current corn production. Also, there is no expected change in air quality
associated with the cultivation of
MON 87460.
Based on this review, APHIS concludes that the cultivation of MON 87460 would comply with
the Clean Water Act and the Clean Air Act.
6.1.4 Impacts on Unique Characteristics of Geographic Areas
A determination of nonregulated status of MON 87460 is not expected to impact unique
characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and
scenic areas, or ecologically critical areas.
The common agricultural practices that would be carried out in the cultivation of MON 87460
are not expected to deviate from current practices. The product is expected to be deployed on
agricultural land currently suitable for production of corn and replace existing varieties, and is
not expected to increase the acreage of corn production.
There are no proposed major ground disturbances; no new physical destruction or damage to
property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease,
or transfer of ownership of any property. This action is limited to a determination of
78
nonregulated status of MON 87460. This action would not convert land use to nonagricultural
use and therefore would have no adverse impact on prime farm land. Standard agricultural
practices for land preparation, planting, irrigation, and harvesting of plants would be used on
agricultural lands planted to MON 87460, including the use of EPA registered pesticides.
6.1.5 National Historic Preservation Act (NHPA) of 1966 as Amended
The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to:
1) determine whether activities they propose constitute "undertakings" that have the potential to
cause effects on historic properties and 2) if so, to evaluate the effects of such undertakings on
such historic resources and consult with the Advisory Council on Historic Preservation (i.e.,
State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate.
APHIS’ proposed action, a determination of nonregulated status of MON 87460 is not expected
to adversely impact cultural resources on tribal properties. Any farming activity that may be
taken by farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes
would have control over any potential conflict with cultural resources on tribal properties.
APHIS’ Preferred Alternative would have no impact on districts, sites, highways, structures, or
objects listed in or eligible for listing in the National Register of Historic Places, nor would it
likely cause any loss or destruction of significant scientific, cultural, or historical resources.
APHIS’ proposed action is not an undertaking that may directly or indirectly cause alteration in
the character or use of historic properties protected under the NHPA. In general, common
agricultural activities conducted under this action do not have the potential to introduce visual,
atmospheric, or noise elements to areas in which they are used that could result in effects on the
character or use of historic properties. For example, there is potential for increased noise on the
use and enjoyment of a historic property during the operation of tractors and other mechanical
equipment close to such sites. Nevertheless, it is expected that this noise would only be
temporary and short-term. The cultivation of MON 87460 is not expected to change any of these
agronomic practices that would result in an adverse impact under the NHPA.
79
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8 LIST OF PREPARERS
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University
B.S. Zoology, University of North Carolina
30 years of experience in human health and ecological risk
assessment
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APPENDIX A. FDA BIOTECHNOLOGY CONSULTATION NOTE TO THE FILE (BNF
NO. 000116)
BIOTECHNOLOGY CONSULTATION - NOTE TO THE FILE
BIOTECHNOLOGY NOTIFICATION FILE BNF NO. 000119
DATE
December 9, 2010
Subject
MON 87460, drought tolerant corn
Keywords
Maize; corn; Zea mays L.; drought tolerance; MON 87460; OECD unique identifier MON-8746Ø-4; cold
shock protein B (CSPB) from Bacillus subtilis; neomycin phosphotransferase II (NPTII) from
Escherichia coli, Monsanto
Purpose
This document summarizes our evaluation of Biotechnology Notification File (BNF) No. 000116. In a
submission dated December 19, 2008, the Monsanto Company (Monsanto) submitted a safety and
nutritional assessment of the bioengineered corn MON 87460. Monsanto provided additional information
in submissions dated April 9, May 1, June 1, June 29, July 7, August 10, September 10, November 2,
2009, and August 3, 2010. Monsanto is voluntarily consulting with the agency as discussed in the
agency’s 1997 Guidance on Consultation Procedures for Foods Derived from New Plant Varieties. Here
we discuss the outcome of the consultation, but do not intend to restate the information provided in the
final consultation in its entirety.
Intended Effects
The intended effect of the modification in corn event MON 87460 is to reduce yield loss under water-
limited conditions compared to conventional corn. To accomplish this objective, Monsanto introduced the
gene (cspB) for cold shock protein B (CSPB) from B. subtilis. CSPB confers tolerance to water-limited
conditions. Monsanto also introduced the gene (nptII) for neomycin phosphotransferase II (NPTII)
protein from E. coli. NPTII was used as a selectable marker in the development of corn event MON
87460. The NPTII protein does not confer tolerance to water-limited conditions.
Regulatory Considerations
The purpose of this evaluation is to assess whether the developer has introduced a substance requiring
premarket approval as a food additive or has unintentionally adulterated the food with respect to the
Federal Food, Drug and Cosmetic Act (FFDCA).
Genetic Modification and Characterization
Parental Variety
Monsanto transformed the recipient LH59 (a non-transgenic conventional corn variety) callus tissue to
obtain MON 87460.
Transformation Plasmid and Method
Monsanto described the development of corn event MON 87460 using Agrobacterium tumefaciens-
mediated transformation of corn embryo-derived tissue. The A. tumefaciens strain harbored the
transformation vector PV-ZMAP595. The transforming vector carried a transfer DNA sequence
comprised of both cspB and nptII expression cassettes. Following transformation, the corn tissue was
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transferred to medium containing the antibiotics carbenicillin to eliminate A. tumefaciens, and
paromomycin (related to neomycin) to eliminate cells that were not transformed.
Characteristics, Inheritance, and Stability of the Introduced DNA
Monsanto provided genomic DNA blot (Southern) analyses to demonstrate that corn event MON 87460
has one intact copy of the transfer DNA region comprised of tandem cspB and nptII expression cassettes
inserted in its genome. Monsanto provided genomic DNA blot analyses and polymerase chain reaction
analyses in conjunction with DNA sequencing to verify the integrity of the integrated cspB and nptII
genes along with their associated regulatory elements. Monsanto used genomic DNA blot analyses to
demonstrate that MON 87460 does not contain any detectable DNA from the transformation vector, other
than the transfer DNA region.
Monsanto presented genomic DNA blot analyses to demonstrate the stability of the inserted cspB and
nptII expression cassettes across multiple generations of corn event MON 87460. Monsanto presented
Chi-square analyses of the segregation patterns across multiple generations of corn event MON 87460 to
demonstrate the stable Mendelian inheritance of the transfer DNA region containing both the cspB and
the nptII cassettes.
Monsanto assessed the inserted DNA sequence for any potential unintended open reading frames (ORFs)
that might encode proteins. Monsanto identified several putative polypeptides of at least eight amino
acids that could be expressed. Monsanto performed bioinformatic analyses to compare sequences within
these putative polypeptides to those of known toxins and allergens in standard toxin, allergen and protein
databases. Monsanto found no similarity to any known allergen or toxin.
Protein Characterization
Function and expression levels of introduced proteins
Monsanto describes the CSPB protein produced in corn event MON 87460 as identical to the native
CSPB protein produced in B. subtilis except for one amino acid introduced for cloning purposes.
Bacterial cold shock proteins (CSP) are hypothesized to function by binding to RNA secondary
structures, thus reducing the free energy required for unfolding misfolded RNA. CSPs are classified as
RNA chaperones. Monsanto notes that similar cold shock domain-containing proteins are also present in
plants where they appear to play a role in conferring stress tolerance.
Monsanto describes the function of the NPTII protein as being a selectable marker used in the
development of corn event MON 87460. NPTII phosphorylates neomycin and related antibiotics, thus
inactivating them.
Monsanto estimated the levels of CSPB and NPTII proteins in corn event MON 87460 from both well-
watered (i.e., received adequate water throughout the growing season) and water-limited plants grown in
the field. Monsanto noted that given the genetic construct of the transferred DNA, both CSPB and NPTII
proteins would be expected to be present in all tissues. Using standard biochemical techniques, Monsanto
reports CSPB protein being present in all tissues tested. Monsanto reports NPTII protein also being
present in all tissues tested, with the exception of mature grain where it was below the detection method’s
limit of quantitation (where the limit of quantitation is 0.0047 micrograms per gram of tissue on a fresh
weight basis).
Potential Toxicity of the Introduced Proteins
Monsanto assessed the potential for toxicity for both CSPB and NPTII proteins. Regarding CSPB,
Monsanto noted that the source of the cspB gene is B. subtilis, a microorganism used as the donor
organism for several enzyme preparations used in food manufacturing applications. In support of the
safety of B. subtilis used in such food applications, Monsanto cited several published studies as well as
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the opinions of expert scientific bodies. In support of the safety of the CSPB protein, Monsanto noted that
it is homologous to several proteins from microbial and plant sources present in the human diet. Using the
CSPB protein sequence, Monsanto performed bioinformatic analyses to look for similarities between
CSPB and proteins known to be toxic or bioactive and found no such similarities. Monsanto also
conducted an acute oral toxicity study in mice (single dose of 4.7 milligrams/kilogram) using E. coli-
produced CSPB protein. Monsanto noted no treatment-related adverse effects. Given the totality of the
evidence, Monsanto concluded that the CSPB protein from corn event MON 87460 is unlikely to exhibit
toxic effects when incorporated into food or feed.
Regarding NPTII, Monsanto stated that the source of the nptII gene is E. coli K-12. NPTII, also referred
to as APH(3')II, is regulated as a food additive under 21 CFR 173.170 and 21 CFR 573.130 for use as a
processing aid in the development of new varieties of tomato, oilseed rape and cotton. Scientific studies
and evaluations regarding the use of NPTII in new plant development have been performed since FDA
filed the food additive petition for these uses. In reviewing NPTII, FDA concluded that NPTII does not
have any properties that would distinguish it toxicologically from any other phosphorylating enzymes in
the food supply. Using the NPTII protein sequence, Monsanto performed bioinformatic analyses, which
found no similarities between NPTII and proteins known to be toxic or bioactive and provided additional
citations supporting its safety. Given the totality of the evidence, Monsanto concluded that the NPTII
protein from corn event MON 87460 is unlikely to exhibit toxic effects when consumed in food or feed.
Assessment of the Potential for Allergenicity of the Introduced Proteins
Monsanto evaluated the potential for allergenicity of CSPB and NPTII proteins. For CSPB and NPTII
proteins, bioinformatics analyses of sequence similarities using standard methods, including the allergen
database in conjunction with the FASTA sequence alignment tool, and an eight-amino acid sliding
window search (ALLERGENSEARCH) revealed no significant homology to known allergens. For the
CSPB protein, in vitro gastric and intestinal digestibility studies using standard methods did not identify
significant resistance to proteolysis. For the NPTII protein, Monsanto cites an FDA draft guidance
document to support its conclusion that the NPTII protein poses no allergenic risk [Guidance for Industry:
Use of Antibiotic Resistance Marker Genes in Transgenic Plants (Draft Guidance, issued September 4,
1998)]. In this draft guidance, FDA states that NPTII protein is known to be rapidly degraded under
simulated gastric conditions, is neither glycosylated nor heat-resistant and lacks homology to known food
allergens using several databases. FDA concludes that there are no allergenicity concerns.
Food & Feed Use
Corn (Zea mays L.) originated in Mexico and was grown as a food crop as early as 2700 B.C. Today, corn
is grown worldwide for food, feed, and industrial uses. Corn grain is used in food primarily in the form of
processed products, such as high fructose corn syrup, cereals, oil, meal, flour, starch, and grits. Corn is a
source of nutritionally important amino acids (methionine and cystine), carotenoids, and vitamin E. Corn
oil is rich in polyunsaturated fatty acids and is used mainly as a salad and cooking oil and in margarine
production.
Corn is also used in animal feed. Corn grain is primarily fed to cattle, poultry, and swine either as intact
or processed grain or as dry or wet milling byproducts, but may be a component of most animal feeds.
Corn silage (entire above ground portion of the corn plant that is harvested prior to maturation) is
primarily fed to ruminants.
Composition
Scope of Analysis
Monsanto analyzed the composition of forage and grain from the MON 87460 corn and compared it with
its near isogenic parental line (a non-transgenic corn variety with a similar genetic background to MON
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87460, hereafter referred to as the comparator control line). Two field studies were summarized in
Monsanto’s submission (United States (U.S.) and Chilean studies).
In the U.S. study, Monsanto evaluated the composition of forage and grain from MON 87460, its
comparator control line, and from a total of eighteen commercial non-transgenic corn varieties.
In the Chilean study, Monsanto evaluated the composition of forage and grain from MON 87460,
its comparator control line, and sixteen commercial non-transgenic corn varieties grown under
water-limited or irrigation conditions.
Monsanto used the data derived from the reference varieties to generate a 99% tolerance1 interval for
each component. Monsanto states that these data illustrate the natural variability in commercially grown
corn varieties grown under similar field conditions.
Study Design - Compositional Analyses
As described by Monsanto, corn event MON 87460 and the comparator control line were grown at six
replicated field sites in corn production regions in the U.S. during the 2006 growing season. At the same
sites, three unique conventional commercial hybrid lines were also grown at each of the six sites, thus
providing a total of 18 commercial references for compositional analyses of forage and grain tissue
samples. Plants in all six sites were grown under commercially acceptable agronomic practices typical for
the area, with four sites being rain-fed and two receiving supplemental irrigation. At each field site, seed
was planted in a randomized block design with three replicates per block. Forage and grain samples were
collected from corn event MON 87460 and the comparator control line from all three blocks. Forage and
grain samples were collected from the three conventional commercial hybrid lines from a single block.
Samples of forage at the early dent plant growth state and grain at physiological maturity were collected
from all plots and analyzed for nutritional components, toxicants, and anti-nutrients. Monsanto measured
and evaluated seven components in forage and 68 in grain. Compositional analyses of the forage samples
included measurement of moisture, crude fat, crude protein, ash, carbohydrates by calculation, acid
detergent fiber (ADF), neutral detergent fiber (NDF), calcium, and phosphorus. Compositional analyses
of the grain samples included measurement of moisture, crude fat, crude protein, ash, carbohydrates by
calculation, ADF, NDF, total dietary fiber (TDF), amino acids (18), fatty acids (C8-C22), minerals
(calcium, copper, iron, magnesium, manganese, phosphorus, potassium, sodium, and zinc), vitamins
(vitamin B1, vitamin B2, vitamin B6, vitamin E, niacin, and folic acid), and key secondary metabolites
(furfural, p-coumaric acid, and ferulic acid), anti-nutrients (raffinose and phytic acid).
Monsanto also described field trials from the 2006-2007 growing season in commercial corn production
regions of Chile. According to Monsanto, these four sites are well-suited to growing corn, but typically do
not receive any rainfall so crops receive water only through controlled irrigation. Monsanto planted corn
event MON 87460, the comparator control line, and four unique commercial conventional hybrid corn
lines per site, providing a total of 16 commercial references for compositional analyses of forage and
grain samples. At the Chilean sites, Monsanto used a strip plot design with three replicates per site with
the water level treatment (either well-watered for optimal growth using irrigation or water-limited to
impose a drought stress during a critical stage of growth) as the whole plot and substance type as the
subplot to allow for a comparison of plants grown under the two different water level treatments.
Monsanto described the whole plot factor as arranged as a randomized complete block design and the
split-plot factor consisting of corn event MON 87460, the comparator control line, and the conventional
commercial hybrid lines. Monsanto collected forage (early dent stage) and grain samples (at physiological
maturity) from corn event MON 87460 and the comparator control line from all three blocks for each
treatment and forage and grain samples from the four conventional commercial hybrid lines from a single
block for each irrigation treatment.
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For the U.S. study, statistical assessments of the compositional data were conducted using mixed model
analysis of variance on each individual site and a comparison across all sites, referred to as the combined
site analysis. For the Chilean field trials, Monsanto described statistical considerations to assess the
effects of the two irrigation treatments. As described by Monsanto, for a site to be considered in the
combined-site analysis, the commercial conventional hybrid lines must have exhibited a phenotypic
response indicative of the treatment. For the water-limited plants, this response was defined as a
minimum of a 15 percent reduction in yield. In summary, for the Chilean field trials, there were four sets
of statistical analyses made for each treatment, three used data from each of the field sites and the fourth
used data from a combined-site analysis
Statistical differences at the 5 percent level (P<0.05) were declared to be significant. Where statistically
significant differences between corn event MON 87460 and the comparator control line were observed,
Monsanto notes that all mean component values of the test and control substances were within the 99
percent tolerance interval established from the commercial references.
Results of analyses:
Monsanto made the following observations and conclusions regarding the results of the levels of
components measured in forage and grain from corn event MON 87460. For the U.S. field trials, 77
different analytical components were measured, 15 had more than 50 percent of the observations below
the assay limit of quantitation. These components are known to be present at low levels in corn grain.
Noted below are statistically significant differences detected for the combined-site analysis only.
Similarly, for the Chilean well-watered field trials, of the 77 different analytical components measured,
16 had more than 50 percent of the observations below the assay limit of quantization.
Compositional analysis of corn forage
Monsanto reported no statistically significant differences in moisture, crude fat, crude protein, ash,
carbohydrates by calculation, ADF, NDF, calcium, and phosphorus levels between MON 87460 and the
comparator control line in the U.S study. Similarly, there were no statistically significant differences in
moisture, crude fat, crude protein, ash, ADF, NDF, calcium, and phosphorus levels in the water-
supplemented treatment in Chile. Carbohydrates by calculation was higher in forage obtained from MON
87460 when compared to the comparator control line in corn grown under water-supplemented treatment,
but the values for MON 87460 and the comparator control line fell within the 99 percent tolerance
interval for conventional varieties grown under similar conditions. Total fat was higher in forage obtained
from MON 87460 when compared to the comparator control line in corn grown under water-limited
conditions, but the values for MON 87460 and the comparator control line fell within the 99 percent
tolerance interval for conventional varieties grown under similar conditions.
Compositional analysis of corn grain
U.S. Study:
Monsanto reported no statistically significant differences in moisture, crude fat, crude protein,
carbohydrates by calculation, ADF, NDF, TDF, minerals (calcium, copper, iron, magnesium, manganese,
phosphorus, potassium, and zinc), all 18 amino acids, 7 fatty acids (palmitic, palmitoleic, oleic, linoleic,
linolenic, arachidic, and behenic acids), 6 vitamins, phytic acid, raffinose, ferulic acid, and p-coumaric
acid between MON 87460 and the comparator control line. Ash and stearic fatty acid contents were
statistically higher in MON 87460 than the comparator control line, but the MON 87460 and comparator
control line values fell within the 99% tolerance interval for conventional varieties grown under similar
conditions. Eicosenoic fatty acid content was statistically lower in MON 87460 when compared to the
comparator control line and both of these values were slightly lower than the lowest value for the 99%
tolerance interval.
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Chilean Water-Supplemented Sub-plot:
Monsanto reported no statistically significant differences in moisture, crude protein, ash, carbohydrates
by calculation, ADF, NDF, TDF, minerals (except for magnesium), all 18 amino acids, the 8 detectable
fatty acids, 6 vitamins, phytic acid, raffinose, ferulic acid, and p-coumaric acid between MON 87460 and
comparator control line. Ash and magnesium contents were statistically higher in MON 87460 than the
comparator control line, but the values for MON 87460 and the comparator control line fell within the
99% tolerance interval for conventional varieties grown under similar conditions.
Chilean Water-Limited Sub-plot:
Monsanto reported no statistically significant differences in moisture, crude fat, crude protein, ash,
carbohydrates by calculation, ADF, NDF, TDF, 8 minerals, 18 amino acids, fatty acids (except eicosenoic
acid), 6 vitamins, phytic acid, raffinose, ferulic acid, and p-coumaric acid between MON 87460 and
comparator control line. Although the values for eicosenoic acids were statistically different, the values
were numerically (at two decimal points) the same and these values fell within the 99 percent tolerance
interval for conventional varieties grown under similar conditions.
Summary of Compositional Analyses
As noted above, in Monsanto’s combined site analyses, a few statistically significant differences were
found in the comparisons of corn event MON 87460 and the comparator control line. Of the statistically
significant differences detected, all mean component values were within the 99 percent tolerance level
established from the commercial references. In addition, the mean levels for each of these components
were within the range of values reported in either the International Life Science Institute (ILSI) Crop
Composition Database (ILSI 2006), the OECD consensus document (OECD, 2002), or both. Monsanto
concluded that the differences were within the natural variability of corn.
Conclusion
FDA evaluated Monsanto’s submission to determine whether the developer’s product raises any safety
issues with respect to the intended modification or with respect to the food itself, as discussed in the
agency’s 1992 Policy Statement on New Plant Varieties. Based on the information provided by the
company and other information available to the agency, FDA did not identify any issues under Sections
402 and 409 of the Federal Food, Drug and Cosmetic Act that would require further evaluation at this
time.
Monsanto has concluded that its drought tolerant corn variety, corn event MON 87460 (MON-8746Ø-4)
and the foods and feeds derived from it are as safe as conventional corn varieties and with the exception
of the drought tolerance trait, are not materially different in composition or any other relevant parameter
from other corn varieties now grown, marketed, and consumed in the U.S. At this time, based on
Monsanto’s data and information, the agency considers Monsanto’s consultation on MON 87460 corn to
be complete
Susan Carlson
1
A 99 percent tolerance interval represents, with 95 percent confidence, 99 percent of the values
contained in the population of commercial conventional corn varieties
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APPENDIX B. POLLEN- AND GENE-MEDIATED GENE FLOW
B.1. Gene Flow among Corn Cultivars
As reviewed by Zapiola and Mallory-Smith (2008), several factors are necessary for and can
affect levels of pollen-mediated and seed-mediated gene flow between plant populations. Table
B-1 lists and describes the many factors that affect gene flow.
Table B-1: Factors that contribute to gene flow due to pollen and seed
Pollen mediated gene flow Seed mediated gene flow
Requires:
Coexistence of pollen donor and receptors
Overlapping flowering phenology
Successful pollination and fertilization
Establishment
Requires:
Dispersal – weather, animals, humans
Factors that increases pollen gene flow:
Feral crop populations and volunteers
Sexually compatible wild relatives
Out-crossing
Self-incompatibility
Large pollen source
Large pollen production
Strong winds (wind pollination)
Lightweight pollen
Insect populations (insect pollination)
Long pollen viability
Favorable weather conditions for pollen viability
(low temp and high humidity)
Factors that increase seed gene flow:
Feral crop populations and volunteers
Small seeds
Lightweight seeds
High seed production
Seed shattering
Seed dormancy
Use of commingled seed
Seed transport
Improperly cleaned machinery
Factors that decrease pollen gene flow:
Isolation of populations
Non-synchronous flowering time
Border rows
Volunteer control
Factors that decrease seed gene flow:
Certified seed
Proper machine cleaning between fields
Proper transport of seeds
Correct product labeling
Volunteer control
Source: Adapted from Zapiola and Mallory-Smith 2008.
B.1.1 Pollen-mediated Gene Flow
Overview of gene flow
For gene flow to occur between corn cultivars or varieties, the pollen donor and pollen receptor
plants must be sexually compatible, flowering phenology must overlap between source and sink
populations, pollen transfer must occur, embryo/seeds must develop, and hybrid seed must
disperse and establish. Corn is a monoecious (both male and female flowers on the same plant),
out-crossing, wind- pollinated crop that produces abundant, large, and heavy pollen. The
reproductive morphology of corn encourages cross-pollination between corn plants and there is
no evidence (genetic or biological barriers) to indicate that gene flow is restricted between
genetically modified, conventional, and organic corn. However, spatial and temporal isolation
can be an effective barrier to gene exchange between corn crop cultivars (Zapiola and Mallory-
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Smith 2008). In addition, current practices for maintaining the purity of hybrid seed production
in corn are typically successful for maintaining 99 percent genetic purity (Ireland et al. 2006).
The following are properties affecting pollen-mediated gene flow from corn:
Physical properties of corn plants: The male and female reproductive structures of
corn are physically separated and contribute to out-crossing. The male structure, the
tassel, is at the top of the corn plant. The female structures, the silks, form at axillary
buds lower on the plant at leaf junctions.
Properties of corn pollen: Corn pollen is very large and heavy (in relation to other grass
species) and, given its large size, pollen is primarily dispersed downwind from tassels
into adjacent rows of planted corn. Once corn pollen is released, its viability depends on
environmental conditions. Viability can be low when conditions are dry only 1 to 4
hours (Bannert 2006) or remain viable for up to 24 hours after shedding under
conditions of cool temperature and high humidity (Luna et al. 2001).
Flower synchrony: Because of the limited viability of corn pollen – 1 to 24 hours, as
stated above and short flowering period of corn plants, synchronization of pollen
dispersal and flowering time is critical for the occurrence of pollen mediated-gene flow
(Zapiola and Mallory-Smith 2008). Cross-pollination between neighboring corn fields
can be effectively reduced, if not prevented, by desynchronizing flowering between fields
by altering planting dates. Halsey et al. (2005) demonstrated that while gene flow could
be detected at 0.01 percent at 1,640 feet (500 meters) from source populations when
flowering time was synchronized, the farthest distance where this level of gene flow
could be detected was 203 feet (62 meters) from source populations when flowering was
desynchronized.
Insect pollination: Insect pollinators (e.g., honeybees) often collect maize pollen from
tassels for feeding and breeding of their larva, but because the female structures lack
nectar production and other attractants, bees typically do not visit the silks. When bee
populations are established before corn flowering, bees often avoid pollen collection from
corn even when corn plants are close, because of bee preference for the flowers of other
plant species. Therefore, insects, and honeybees in particular, do not usually contribute
to fertilization and cross-pollination (Bannert 2006).
Wind pollination: Wind pollination is the primary and most effective mechanism for
fertilization and cross-pollination, or gene flow, between corn plants. Variation in
flowering timing within corn crop fields can increase the flowering window of a given
corn field. However, to maximize yield, most corn varieties have been selected to have a
synchronous flowering time within the same field. Depending on genotypic and
environmental factors, tassels typically shed pollen for 2 to 14 days (Bannert 2006).
Pollen is typically released during dry and drying conditions, and often released in
advance of changing atmospheric conditions (Bannert 2006). Tassel maturity and pollen
release can occur on corn plants exposed to drought conditions, but silk deployment is
delayed, reducing the fertilization and pollination window of drought-affected corn plants
(Hall and Twidwell 2002). Rain is disadvantageous for pollen dispersal and frequent
rainy weather can reduce fertilization in corn crops.
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Pollen migration distance: As stated above, corn pollen is very large and heavy (in
relation to other grass species) and is primarily dispersed downwind from tassels into
adjacent rows of planted corn. Thus, isolation distances can reduce movement of most of
the pollen between two corn fields, but based on the evidence from these studies,
complete confinement is not likely. Generally, most of the pollen moves within 9 to 49
feet (6 to 15 meters) of the donor plant, although wind can carry pollen for much greater
distances. Numerous studies have examined the rate of pollen-mediated gene flow
between corn populations (reviewed in Sanvido et al. 2008). Because of the multitude of
different experimental designs results vary between studies, but most demonstrate that
cross-fertilization rates drop below 1 percent within 33 feet (10 meters) of source plants,
and levels of cross-fertilization (gene flow) was maintained below 0.5 percent within the
first 164 feet (50 meters) (Sanvido et al. 2008). Early studies examining gene flow from
corn demonstrated gene flow up to 1,650 feet [503 meters] from source fields (Jones and
Brooks 1950), but many more recent studies suggest that gene flow distance follows an
exponential decrease and diminishes greatly with increasing distance from source fields
more than 656 feet [200 meters]) (Sanvido et al. 2008, Ireland et al. 2006), but limited
instances of long-distance (more than 1,148 feet [350 meters]) low-level gene flow can
occur when weather conditions, such as high winds, cool temperatures, and high
humidity, contribute to increased pollen viability and dispersal (Bannert 2006).
Border rows and field size: Planting of border rows at corn fields can contribute to
reductions in gene flow, but cannot prevent it because turbulent wind currents can
contribute to pollen dispersal beyond sink-field borders and some studies have
demonstrated higher rates of gene flow from adjacent fields into field borders (Ireland et
al. 2006). Luna et al. (2001) examined the effects of varied isolation distances between
maize plants in Mexico, and found that low levels of cross-pollination occurred at 328
feet (100 meters) and that no pollination occurred at distances beyond 656 feet. Other
researchers have shown that pollination can be as high as 60 percent between contiguous
rows, but that from more remote rows it decreased with increasing distance such that no
outcrosses were found 105 feet (32 meters) away from the pollen source (Castillo and
Goodman 1997, Louette 1996). In large, field-based assessments of corn gene flow in
the United Kingdom, Weekes et al. (2007) demonstrated that gene flow rates decreased
rapidly with increasing distance from the GE source, but can be detected at distances up
to and including 656 feet from the GE source. In addition, computer-based models
predict that rates of gene flow can increase as the size of GE fields increase (Kuparinen et
al. 2007).
Pollen competition: A comparison of the risk of open-pollinated corn cultivation (non-
hybrid) versus hybrid corn cultivation suggests that cross-fertilization rates are higher in
open pollination production (Sanvido et al. 2008). However, research by Goggi et al.
(2007) evaluated the effects of pollen competition (gene flow from a source into an
established stand of corn) on gene flow between GE and non-GE corn. At distances of
more than 328 feet (100 meters), the out-crossing frequency between GE corn and non-
GE corn decreased to below 0.1 percent in fields with reduced pollen competition and
below 0.03 percent in fields with normal pollen competition. These results indicate that
when local pollen levels are low, incoming pollen has a competitive advantage, which
results in a notably greater frequency of out-crossing than when the local pollen is
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abundant. Accordingly, large corn donor fields can contribute to greater pollen flow into
small recipient fields as a result of pollen competition (Jemison and Vayda 2001).
Similarly, because of the low production of pollen in hybrid corn fields, low pollen
competition could contribute to higher rates of cross-fertilization if temporal or spatial
isolation is not observed (Zapiola and Mallory-Smith 2008).
B.1.2 Seed-mediated Gene Flow
Overview of seed dispersal
For gene flow to occur via seeds and result in feral populations of corn, seeds must disperse and
establish in new habitats. Through thousands of years of selective breeding by humans, corn has
been extensively modified to depend on human cultivation for survival. Several key weedy traits
that would contribute to crop escape, traits associated with ferality and volunteerism, have been
selectively reduced in corn, resulting in a crop species not equipped for survival without
management (Gould 1968). Also, several traits greatly reduce the ability of corn to disperse via
seeds. Humans have selected corn to produce seeds that do not shatter and cannot disperse from
the cob, and corn seeds are tightly bound within a protective sheath of leaves, or husk (Zapiola
and Mallory-Smith 2008). Corn seeds also lack dormancy, preventing easy persistence between
seasons in fields or in the weed seed bank. While corn grains or cobs left in fields after harvest
can result in volunteers in the following year, because of the tightly bound nature of the corn
seeds, competition between siblings can reduce fitness. The following are properties affecting
seed-mediated gene flow from corn:
Human mediated seed dispersal: Human-influenced seed-mediated gene flow in corn
could occur as a result of seed mixing following improper cleaning of field machinery,
and improper seed purity and certification methods. As described in Section 3.3.5, corn
seed is almost exclusively produced as hybrid lines, with great care taken to maintain
parental stock lines. However, in almost all current corn production, corn is planted as
hybrid seed to reduce intra-field variation in plant height, flower synchrony, and harvest.
Because of the nearly exclusive cultivation of hybrid lines that must be produced yearly
by intentional hybridization between two different inbred lines, corn seed is not saved in
the United States from previous harvests for replanting in subsequent years; instead, it
purchased each year (Fernandez-Cornejo 2004). Feral corn plants can sometimes occur
along roadsides as a result of seed spill during transport, but do not typically persist
because of the same factors that reduce persistence in fields. Therefore, the purity of
seed stocks purchased in each year would determine seed-mediated gene flow into corn
fields.
Animal mediated seed dispersal: Several different animal species (e.g., deer, wild boar,
and waterfowl) will consume scattered corn if it is present, but dispersal of viable seeds is
limited. Research by scientists in Germany has demonstrated that corn seeds do not
survive digestion by deer, and survival of viable GE corn seeds through wild boar is
extremely limited (0.009 percent) (Guertler et al. 2008, Wiedemann et al. 2009). In
addition, research by Cummings et al. (2008) demonstrated that passage of viable corn
seed does not occur through mallard ducks and rock pigeons.
Seed traits and weediness of corn: The domestication history of corn has resulted in
the production of a plant species that has a greatly reduced ability to persist and survive
101
outside of human cultivation. Lack of seed dormancy prevents accumulation of corn in
weed seed banks, and lack of seed shatter and encasement within corn husks prevents
dispersal of seeds. Therefore, corn is not suited to survive without human management
and is not typically described as a weed (Baker 1965, Keeler 1989, Galinat 1988). Corn
is not present as a noxious weed on federal lists ((USDA-APHIS 2010, Crockett 1977,
Holm et al. 1979, Muenscher 1980) though the Southern Weed Science Society lists it as
a weed (USDA-NRCS 2010). Volunteer corn can sometimes overwinter and occur in
fields following cultivation and crop rotation, particularly with soybeans, but does not
persist and can be controlled using mechanical or chemical measures. In addition,
persistent populations of feral corn are not common along transportation routes or other
weedy environments (see Zapiola and Mallory-Smith 2008). Based on the traits of
modern corn and the factors necessary for corn to establish in new populations, it is not
likely that gene flow will occur via seeds into new feral corn populations.
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APPENDIX C. CHARACTERISTICS MEASURED FOR PHENOTYPIC,
AGRONOMIC, AND ENVIRONMENTAL INTERACTIONS
ASSESSMENT OF MON 87460
Characteristic
Characteristic
Measured
Evaluation
Timing
Evaluation Description (measurement
endpoints
Plant phenotypic
and agronomic
characteristics
Dormancy,
Germination
After 4, 7, and 12 days Percent normally germinated, abnormally
germinated, viable hard (dormant), dead, and
viable firm swollen seed
Seedling vigor Stage V2–V4 Rated as: 1-3 = above average vigor, 7-9 =
below average vigor (2007 scale) or, where 0
= dead, and 9 = above average vigor (2006
scale)
Early stand count Stage V2–V4
N
umber of emerged plants per plot
Final stand count Pre-harvest
N
umber of plants per plot
Stay green Maturity
Rated as: 1 = 90-100% green tissue, 5 = 50-59%
green tissue, 9 = 0-19% green tissue (2007 rating
scale) or, 0 = entire plant dried, and 9 = entire
plant green (2006 rating scale)
Ear height Maturity
Distance from the soil surface at the base of the
plant to the ear attachment node
Plant height Maturity
Distance from the soil surface at the base of the
plant to the flag leaf collar
Stalk lodged plants Pre-harvest
N
umber of plants per plot broken below the
ear
Root lodged plants Pre-harvest
N
umber of plants per plot leaning at the soil
surface at >30° from the vertical
Days to 50% pollen shed Pollen shed
Days from planting until 50% of the plants have
begun to shed pollen
Days to 50% silking Silking
Days from planting until 50% of the plants have
silks exposed
Pollen viability Tasseling
Viable and nonviable pollen based on pollen
grain staining characteristics
Pollen morphology Tasseling
Diameter of viable pollen grains
Grain moisture Harvest
Moisture percentage of harvested shelled grain
Test weight (lb/bu) Harvest
Test weight of harvested shelled grain
Yield (bu/ac) Harvest
Harvested weight of shelled grain, adjusted to
15.5% moisture
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Characteristic
Characteristic
Measured
Evaluation
Timing
Evaluation Description (measurement
endpoints
Dropped ears Pre-harvest
N
umber of mature ears dropped from plants
Plant
environmental
interactions
Insect, disease and abiotic
stressors
Variable, from planting
to harvest
Qualitative assessment of each plot, with rating
on a 0-9 scale for plant-insect, plant-disease, and
plant response to abiotic stressor interactions
Abiotic stress tolerance to
drought, cold, heat, and
salt
Stage V2–V6
Conducted in greenhouse and growth chamber
experiments. Measurements included plant
height, growth stage, vigor, chlorophyll content,
and biomass.
Volunteer potential After fall planting and
following spring
N
umber of plants present as volunteer corn in
plots
Survival outside of
cultivation
Variable, from planting
to harvest
Variable, phenotypic assessments from planting
to harvest that includes early and final stand
counts, vigor ratings, plant height, and number of
ears and seed per plot
Source: (Reeves, 2010)
