NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND MONSANTO COMPANY EVENT MON CORN
NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

FINDING OF NO SIGNIFICANT IMPACT


MONSANTO COMPANY

EVENT MON 87460 CORN


United States Department of Agriculture

Animal and Plant Health Inspection Service

Biotechnology Regulatory Services


The United States Department of Agriculture (USDA), Animal and Plant Health Inspection
Service (APHIS) has developed this decision document to comply with the requirements of the
National Environmental Policy Act (NEPA) of 1969, as amended, the Council of Environmental
Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing
regulations and procedures. This NEPA decision document, a Finding of No Significant Impact
(FONSI), sets forth APHIS' NEPA decision and its rationale. Comments from the public
involvement process were evaluated and considered in developing this NEPA decision.


In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS has
prepared an Environmental Assessment (EA) to evaluate and determine if there are any
potentially significant impacts to the human environment from a determination on the regulated
status ofa petition request (APHIS Number 09-055-01p) by Monsanto Company (Monsanto) for
their genetically engineered MON 87460 drought tolerant (DT) com (hereafter referred to as
MON 87460). MON 87460 is designed to mitigate grain yield loss under water-limited
conditions. This EA has been prepared in order to specifically evaluate the effects on the quality
of the human environment' that may result from a determination ofnonregulated status ofMON
87460. The EA assesses alternatives to a determination ofnonregulated status ofMON 87460
and analyzes the potential environmental and social effects that result from the proposed action
and the alternatives.


Regulatory Authority
"Protecting American agriculture" is the basic charge of 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, organic, or the use of
genetically engineered (GE) varieties) 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


I
Under NEPA regulations, the "human environment" includes "the natural and physical environment and the
relationship of people with that environment" (40 CFR §50S.14).

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: (I) 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 ofthe 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 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 provisions 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.


The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides on and in food
and animal feed, or establishes an exemption from the requirement for a tolerance, under the
Federal Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control
organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for
regulating the sale, distribution and use ofpesticides, including pesticides that are produced by
an organism through techniques of modem biotechnology.


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
2

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 ofthe 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.


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 ofGE organisms. As required
by 7 CFR 340.6, APHIS must respond to petitioners who request a determination of the
regulated status ofGE organisms, including GE plants such as MON 87460. When a petition for
nonregulated status is submitted, APHIS must make a determination if the GE 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.


Monsanto has submitted a petition (APHIS Number 09-055-01p) to APHIS seeking a
determination that their genetically engineered MON 87460 drought tolerant com is unlikely to
pose a plant pest risk and, therefore, should no longer be a regulated article under regulations at 7
CFR Part 340.


Monsanto Event MON
87460 Corn
MON 87460 is designed to mitigate grain yield loss under water-limited conditions. As detailed
in the Monsanto petition, the enhanced drought tolerance of MON 87460 results from the
introduction and controlled expression ofcold shock protein B (cspB), a native ribonucleic acid
(RNA) chaperone derived from Bacillus subtilis (Monsanto, 2010). The enhanced drought
tolerant phenotype of MON 87460 manifests primarily as reduced yield loss relative to
conventional com 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 com. 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 com growth and
development, resulting in an increased number of kernels per ear (Monsanto, 2010).


Drought is one of the major limiting factors in com that prevents realization of optimum grain
yield worldwide (Boyer, 1982). In North America alone, it is estimated that 40 percent of


3

distributed crop loss insurance indemnities are due to sub-optimal water availability (Boyer,
1982). In temperate zone areas of commercial com 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 aI., 2005).


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 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 ofMON 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 com (FDA, 2010).


Scope of the Environmental Analysis
The scope of analysis includes any land in the U.S. currently producing com, any land that is
currently producing crops that could incorporate a com rotation, as well as land that could be
converted from inactive cropland to active cropland, and land currently in the Conservation
Reserve Program (CRP) that could be removed from the program and farmed. Conversion of
grassland, forest, or other land types to cropland as a result of a determination of nonregulated
status of 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 the EA. Furthermore, as described in Chapter 4 of the
EA, MON 87460 is unlikely to significantly increase future com acreage beyond USDA-ERS
projected expansion in irrigated U.S. com 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 com and therefore MON 87360
is not anticipated to expand com acreage into areas not currently used for com production. To
determine areas of com production, APHIS used data from the National Agricultural Statistics
Service (NASS) 2007 Census of Agriculture to determine where com is produced in the United
States (USDA, 2009). Com grain was commercially produced in all states except Alaska.


Public Involvement
On May 11,2011, APHIS published a notice in the Federal Register (76 FR 27303-27304,
Docket no. APHIS-20 11-0023) announcing the availability of the Monsanto petition, and the
APHIS PPRA and draft EA for a 60-day public review and comment period. Public comments
were initially solicited for a 60-day public comment period ending July 11,2011; however,
APHIS extended the public comment period for an additional 30 days (76 FR 44892-44893,
docket number APHIS-2011-0023). Comments were required to be received on or before
August 12,2011. A total of 250 comments were received from various groups and individuals
during the 90 day comment period. The majority of the comments (229) opposed the
development and use of genetically engineered foods and/or MON87460 com, while 21
comments supported a determination ofnonregulated status of MON87460 com. Three of the
comments opposing a determination of nonregulated status included submitted electronic
attachments that consisted either of: a) a single letter signed by numerous people (6,335
4

signatures); b) many letters containing identical material (16,742 letters); or c) a consolidated
document of comments (22,500). Public comments included individual submissions, form
letters, and various electronic media encompassing both the peer-reviewed and non-peer­
reviewed literature. Comment documents may be viewed at


http://www.regu!ations.gov/#!searchResults:dct=PS;rpp=l 0;po=0:s=APHIS-2011-0023. All
comments were carefully analyzed to identifY new issues, alternatives, or information.
Responses to substantive comments are included as an attachment to this Finding of No
Significant Impact.
Major Issues Addressed in the EA


The issues considered in the EA were developed based on APHIS' determination that certain
genetically engineered organisms are no longer subject to the plant pest provisions ofthe Plant
Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a
determination of nonregulated status of MON 87460. Issues discussed in the EA were
developed by considering public concerns as well as issues raised in public comments submitted
for other environmental assessments of genetically engineered 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 com using various production methods,
and the environmental and food/feed safety of genetically engineered plants were addressed to
analyze the potential environmental impacts ofMON 87460.


The EA describes the alternatives considered and evaluated using the identified issues. The
following issues were identified as important to the scope ofthe analysis (40 CFR 1508.25):


Management considerations:


• Acreage and areas of com production
• Cropping practices
• Specialty com production
Environmental considerations:


• Water use and quality
• Soil
Climate change
Animals
Plants
Biological diversity
Gene movement
Human health considerations:


• Public health
• Worker safety
• Livestock feed
Socioeconomic considerations:


• Domestic economic environment
• Trade economic environment
5

Alternatives that were fully analyzed
The EA analyzes the potential environmental consequences of a determination of nonregulated
status of MON 87460. 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, 20 I 0) 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 ofthe Plant Protection Act. Two alternatives were evaluated in the EA: (1)
no action and (2) determination ofnonregulated status ofMON 87460. APHIS has assessed the
potential for environmental impacts for each alternative in the Environmental Consequences
section ofthe EA.


No Action: 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 ofMON 87460 and measures to ensure physical and reproductive confinement
would continue to be implemented. APHIS might choose this alternative ifthere 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 ofplant pest risk
status and responding to the petition for nonregulated status.


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 ofMON 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 ofthe 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.


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


6

MON 87460. Based on this evaluation, APHIS rejected several alternatives. These alternatives


are discussed briefly below along with the specific reasons for rejecting each.


Prohibit any MON 87460from being released


In response to public comments that stated a preference that no GE organisms enter the


marketplace, APHIS considered prohibiting the release ofMON 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 has concluded that MON 87460 is unlikely to pose a plant pest risk.
Accordingly, there is no basis in science for prohibiting the release of MON87460.


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.


Isolation distance between MON 87460 and non-GE corn 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 com 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.


7

APHIS also considered geographically restricting the production ofMON 87460 based on the
location of production of non-GE com 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 com productions systems from MON 87460 or to use isolation distances and other
management practices to minimize gene movement between com fields. Information to assist
growers in making informed management decisions for MON 87460 is available from
Association of Official Seed Certifying Agencies (AOSCA 2009).


Requirement ofTesting 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 oftesting 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.


Environmental Consequences of APHIS' Selected Action
The EA contains a full analysis of the alternatives to which we refer the reader for specific
details. The following table briefly summarizes the results for each of the issues fully analyzed
in the Environmental Consequences section of the EA.


Satisfied through use of
Satisfied - risk assessment (USDA-APHIS 2010)

regulated field trials

8

AttributelMeasure

Alternatiye B: Determination
ofNonregulated Status
Unchanged
Cropping practices Unchanged Unchanged
Seed Corn Production Unchanged Unchanged
Impact to Specialty Corn Unchanged
Water use Unchanged Unchanged
Air Quality Unchanged Unchanged
Animals Unchanged Unchanged
Biological Diversity Unchanged Unchanged
Human and Animal Health Unchanged
Risk to Worker Safety Unchanged Unchanged
Socioeconomic
Unchanged
Trade Economic
Environment Unchanged Unchanged
Other U.S Regulatory
Approvals
FDA completed
consultations
CWA, CAA, EOs Fully compliant
Alternative A: No Actiou
Acreage and Areas of Corn
Production
Minimal
Unchanged
Pesticide use
Unchanged
Unchanged
Organic Farming
Unchanged
Unchanged
Environment
Unchanged
Soil
Unchanged
Unchanged
Climate Change
Unchanged
Unchanged
Plants
Unchanged
Unchanged
Gene Movement
Minimal

Risk to Human Health
Unchanged
Unchanged
Risk to Animal Feed
Unchanged

Domestic Economic
Environment
Unchanged

Unchanged

Social Environment
Unchanged

FDA completed
consultations

Compliance with Other Laws
Fully compliant
*Unchanged - no slgmficant change expected
*Minimal - possibly small changes but no significant differences


9
Finding of No Significant Impact


The analysis in the EA indicates that there will not be a significant impact, individually or
cumulatively, on the quality of the human environment as a result of this proposed action. I
agree with this conclusion and therefore find that an EIS need not be prepared. This NEPA
determination is based on the following context and intensity factors (40 CFR 1508.27):


Context - The term "context" recognizes potentially affected resources, as well as the location
and setting in which the environmental impact would occur. This action has potential to affect
conventional and organic corn production systems, including surrounding environments and
agricultural workers; human food and animal feed production systems; and foreign and domestic
commodity markets. Corn grain is commercially produced in all U.S. states except Alaska
(USDA, 2009). During the

2009/2010

market year, 86.4 million acres of corn were planted and
approximately 13.1 billion bushels of com were harvested in the U.S. with 86 percent of all corn
planted in 2010 representing a GE variety (USDA-ERS, 2010; USDA-ERS, 2010a). Of the 13.1
billion bushels, 11.1 billion bushels entered the domestic market and 2 billion bushels were
exported (USDA-ERS, 2011). U.S. farmers are projected to increase planted com acreage from


86.5 million acres in

2009110

to 92 million acres in 2020/21(USDA-ERS, 2010a, 2011).


As described in Chapter 4 of the EA, MON 87460 would be cultivated in areas that already
support economically viable com production. MON 87460 does not exhibit traits that would
allow it to establish outside the agricultural environment. 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 com acreage into areas not currently used for com production. As a
result, MON 87460 could be grown on any land in the U.S. currently producing com, any land
that is currently producing crops that could incorporate a com rotation, as well as land that could
be converted from inactive cropland to active cropland, and land currently in the Conservation
Reserve Program that could be removed from the program and farmed. Conversion of grassland,
forest, or other land types to cropland as a result of a determination of nonregulated status of
MON 87460 would be less likely because these types of conversions have not been notable
contributors to cropland over the past 18 years. A determination of nonregulated status of MON
87460 is not expected to directly cause an increase in agricultural acreage devoted to com
production beyond projected USDA-ERS increases and is not anticipated to change the
availability of GE and non-GE com varieties on the market. The projected increase in com
acreage that occurs independently ofMON 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.


intensity - Intensity is a measure of the degree or severity of an impact based upon the ten
factors. The following factors were used as a basis for this decision:


1. impacts that may be both beneficial and adverse.


A determination ofnonregulated status ofMON 87460 will have no significant
environmental impact in relation to the availability of GE, conventional, organic or
specialty com varieties. As discussed in Chapter 4 of the EA, a determination of
nonregulated status ofMON 87460 is not expected to directly cause an increase in
agricultural acreage devoted to com production beyond projected USDA-ERS increases.
The availability ofMON 87460 will not change cultivation areas or cropping practices
10

for corn production. MON 87460 would be cultivated in areas that already support
economically viable corn production. MON 87460 does not exhibit traits that would
allow it to establish outside the agricultural environment. Minimum moisture
requirements are similar between MON 87360 and conventional corn. 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. A determination ofnonregulated status ofMON 87460
could add another GE com variety to the conventional com market and is not expected
to change the availability of GE and non-GE corn varieties on the market. The projected
increase in com acreage that occurs independently ofMON 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. Corn-related farm incomes could increase in areas that
adopt MON 87460. The impact of such an increase in returns would be greater for states
where farms represent a greater share of state gross domestic product and where com
represents a greater share of crop acreage. Impacts on overall farm household incomes
due to a determination ofnonregulated status ofMON 87460 are expected to be
negligible. Growers will likely experience less yield loss with MON 87460 than those
incurred by planting non-drought tolerant corn varieties. MON 87460 is designed to
provide increased yield security in current com-producing areas that are subject to
moderate drought stress and is expected to reduce yield loss,by six percent or more under
water-limited conditions compared to conventional com (Monsanto, 2010). To some
extent, all U.S. com varieties have been becoming more drought resistant over time (Yu
and Babcock, 2010), but others have been specially selected for drought tolerance.
Therefore, the impacts of a determination of nonregulated status of MON 87460 would
not likely be different from the corn seed options that currently exist. 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 ofa determination ofnonregulated status ofMON 87460, there
could be a potential for increased corn seed exports. Because com seed exports are a
small share oftotal 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.


2. The degree to which the proposed action affects public health or safety.

A determination of nonregulated status ofMON 87460 would have no significant
impacts on human or animal health. The food/feed nutritional and safety assessment for
MON 87460 has been reviewed by the FDA. 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 on December 19,2008. Based on the information
provided by Monsanto, FDA completed their consultation on MON 87460 on December
10, 2010 and had no further questions concerning MON 87460 drought tolerant corn
(FDA, 2010). Based on the assessment oflaboratory data provided by Monsanto in the
11

submitted petition and an analysis of the scientific literature (USDA-APHIS, 2010),


along with the completion ofthe consultation process with FDA regarding the CSPB and


NPTII proteins ofMON 87460, APHIS has concluded that a determination of


nonregulated status ofMON 87460 would have no adverse impacts on human or animal


health.


3. Unique characteristics ofthe geographic area such as proximity to historic or cultural
resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically
critical areas.

There are no unique characteristics of geographic areas such as park lands, prime farm
lands, wetlands, wild and scenic areas, or ecologically critical areas that would be
adversely impacted by a determination ofnonregulated status ofMON 87460. The
common agricultural practices that would be carried out under the proposed action will
not cause major ground disturbance; do not cause any physical destruction or damage to
property; do not cause any alterations of property, wildlife habitat, or landscapes; and do
not involve the sale, lease, or transfer of ownership of any property. This action is
limited to a determination of non regulated status ofMON 87460. The product will be
deployed on agricultural land currently suitable for production of corn, will replace
existing varieties, and is not expected to increase the acreage of corn production.
Progeny of this variety that express the identified traits of the MON 87460 will be
retained by Monsanto or licensed users. 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. Applicant's adherence to EPA label use restrictions for all
pesticides will mitigate potential impacts to the human environment. In the event ofa
determination ofnonregulated status ofMON 87460, the action is not likely to affect
historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic
rivers, or ecologically critical areas that may be in close proximity to corn production
sites.


4. The degree to which the effects on the quality ofthe human environment are likely to be
highly controversial.

The effects on the quality ofthe human environment from a determination of
nonregulated status ofMON 87460 are not highly controversial. Although there is some
opposition to a determination of nonregulated status ofMON 87460, this action is not
highly controversial in terms of size, nature or effect on the natural or physical
environment. As discussed in Chapter 4 of the EA, a determination ofnonregulated
status ofMON 87460 is not expected to directly cause an increase in agricultural acreage
devoted to com production, or those com acres devoted to GE com cultivation. The
availability ofMON 87460 will not change cultivation areas for corn production in the


U.S. and there are no anticipated changes to the availability ofGE and non-GE corn
varieties on the market. MON 87460 is not expected to directly cause an increase in
agricultural acreage devoted to com production beyond projected USDA-ERS increases.
A determination ofnonregulated status ofMON 87460 will not result in changes in the
current practices of crop rotation, tillage, and herbicide and pesticide use. MON 87460
exhibits similar agronomic and growth characteristics to conventional corn, with the
exception of reduced grain yield loss under water-limiting conditions. Physiological


12

evidence and recorded measures of moisture depletion strongly indicate that water use


(uptake of water by the plant) is not different between MON 87460 and conventional


com (Monsanto, 2010). The effect ofMON 87460 on wildlife or biodiversity is no


different than that of other GE or non-GE com produced in conventional agriculture in


the U.S. During the public comment period, APHIS received comments opposing a


determination ofnonregulated status ofMON 87460. Many of these public comments


expressed a general opposition to genetically modified organisms (GMOs) or GE crops


and the domestic regulatory process surrounding GE plants; perceived negative effects on


public and animal health, biodiversity, and the environment; and a lack of consideration


regarding organic production systems and the public right to choose non-GE containing


food products. The majority of these public comments did not explain or identify


elements in the MON87460 com PPRA or EA that were perceived to be inadequate or


provide any supporting evidence for their claims. However, several specific issues


related to the MON87460 EA were identified. APHIS has addressed these concerns in


the response to public comments document attached to this FONSI based on scientific


evidence found in peer-reviewed, scholarly, and scientific journals.


5. The degree to which the possible effects on the human environment are highly uncertain
or involve unique or unknown risks.

Based on the analysis documented in the EA the possible effects on the human
environment are well understood. The effects of the proposed activities are not highly
uncertain and do not involve unique or unknown risks on the natural or physical
environment. As discussed in Chapter 4 of the EA, a determination of nonregulated
status ofMON 87460 is not expected to directly cause an increase in agricultural acreage
devoted to com production, or those com acres devoted to GE com cultivation. The
availability ofMON 87460 will not change cultivation areas for com production in the


U.S. and there are no anticipated changes to the availability of GE and non-GE com
varieties on the market. MON 87460 is not expected to directly cause an increase in
agricultural acreage devoted to com production beyond projected USDA-ERS increases.
A determination of nonregulated status of MON 87460 will not result in changes in the
current practices of crop rotation, tillage, and herbicide and pesticide use. MON 87460
exhibits similar agronomic and growth characteristics to conventional com, with the
exception of reduced grain yield loss under water-limiting conditions. Physiological
evidence and recorded measures of moisture depletion strongly indicate that water use
(uptake ofwater by the plant) is not different between MON 87460 and conventional
com (Monsanto, 2010). The effect ofMON 87460 on wildlife or biodiversity is no
different than that of other GE or non-GE com produced in conventional agriculture in
the U.S. As described in Chapters 2 and 4 of the EA, well established management
practices, production controls, and production practices (GE, conventional, and organic)
are currently being used in com production systems (commercial and seed production) in
the U.S. Therefore, it is reasonable to assume that farmers, who produce conventional
com (GE and non-GE varieties), MON 87460, or produce com using organic methods or
specialty systems, will continue to use these reasonable, commonly accepted best
management practices for their chosen systems and varieties during agricultural com
production. Additionally, most ofthe com acreage in the U.S. is planted to GE com.
During the 200912010 market year, 86.4 million acres of com were planted and
approximately 13.1 billion bushels of com were harvested in the U.S. with 86 percent of


13

all corn planted in 2010 representing a GE variety (USDA-ERS, 2010; USDA-ERS,


2010a). GE corn varieties represent a progressively increasing proportion of total U.S.


corn planted, ranging from a low of 25% in 2000 to 86% in 20 I 0 (USDA-ERS, 20 I 0).


Based upon historic trends, conventional production practices that use GE varieties will


likely continue to dominate in terms of acreage with or without a determination of


nonregulated status ofMON 87460. Given the extensive experience that APHIS,


stakeholders, and growers have in dealing with the use of GE com products, the possible


effects to the human environment from the release of a an additional GE com product are


already well known and understood. Therefore the impacts are not highly uncertain, and


do not involve unique or unknown risks.


6. The degree to which the action may establish a precedent for future actions with
significant effects or represents a decision in principle about a future consideration.
A determination ofnonregulated status ofMON 87460 would not establish a precedent
for future actions with significant effects or represent a decision in principle about a
future decision. Similar to past regulatory requests reviewed and approved by APHIS, a
determination of nonregulated status will be based upon an independent determination on
whether an organism is unlikely to pose a plant pest risk pursuant to the regulatory
requirements of7 CFR part 340. Each petition that APHIS receives is specific to a
particular GE organism and undergoes this independent review to determine if the
regulated article poses a plant pest risk. 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 who request a determination of the regulated status of GE
organisms, including GE plants such as MON 87460. When a petition for nonregulated
status is submitted, APHIS must make a determination if the GE organism is unlikely to
pose a plant pest risk. If APHIS determines based on its Plant Pest Risk Assessment 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 regulations at 7 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 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 of7 CFR
part 340 or the plant pest provisions ofthe Plant Protection Act when APHIS determines
that it is unlikely to pose a plant pest risk.


14

7.

Whether the action is related to other actions with individually insignificant but
cumulatively significant impacts.

No significant cumulative effects were identified through this assessment. The EA
discussed cumulative effects on corn management practices, human and animal health,
and the environment and concluded that such impacts were not significant. In Chapter 5
of the EA, a cumulative effects analysis is included for each environmental issue
analyzed in the EA. In the event of a determination of nonregulated status, MON 87460
may be stacked (combined) with non-GE and GE corn varieties by traditional breeding
techniques, resulting in a plant that, for example, may also be insect resistant or herbicide
tolerant. There is no guarantee that MON 87460 will be stacked with any particular GE
variety that has previously been determined to no longer be subject to the regulatory
requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act,
as company plans and market demands playa significant role in those business decisions.
Moreover, MON 87460 could even be combined with non-GE corn varieties. Thus,
predicting all potential combinations of stacked varieties that could be created using both
GE corn varieties that have previously been determined to no longer be subject to the
regulatory requirements of 7 CFR part 340 or the plant pest provisions ofthe Plant
Protection Act and also non-GE corn varieties is hypothetical and purely speculative. In
the event of a determination of nonregulated status of MON 87460, APHIS has not
identified any significant impact on the environment which may result from the
incremental impact of a determination of nonregulated status of MON 87460 when added
to other past, present, and reasonably foreseeable future actions.


8. The degree to which the action may adversely affect districts, sites, highways, structures,
or objects listed in or eligible for listing in the National Register ofHistoric Places or
may cause loss or destruction ofsignificant scientific, cultural, or historical resources ..

A determination of non regulated status ofMON 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.
A determination ofnonregulated status ofMON 87460 would have no impact on
districts, sites, highways, structures, or objects listed in or eligible for listing in the
National Register of Historic Places, nor would it likely cause any loss or destruction of
significant scientific, cultural, or historical resources. This action is limited to a
determination ofnonregulated status ofMON 87460. Standard agricultural practices for
land preparation, planting, irrigation, and harvesting of plants would be used on these
agricultural lands including the use of EPA registered pesticides. Applicant's adherence
to EPA label use restrictions for all pesticides will mitigate impacts to the human
environment. A determination ofnonregulated status ofMON 87460 is not an
undertaking that may directly or indirectly cause alteration in the character or use of
historic properties protected under the National Historic Preservation Act. In general,
common agricultural activities conducted under this action do not have the potential to
introduce visual, atmospheric, or audible elements to areas in which they are used that
could result in effects on the character or use of historic properties. For example, there is
potential for audible effects on the use and enjoyment of a historic property when
common agricultural practices, such as the operation of tractors and other mechanical
equipment, are conducted close to such sites. A built-in mitigating factor for this issue is


15

that virtually all of the methods involved would only have temporary effects on the


audible nature of a site and can be ended at any time to restore the audible qualities of


such sites to their original condition with no further adverse effects. Additionally, these


cultivation practices are already being conducted throughout the corn production regions.


The cultivation ofMON 87460 does not inherently change any ofthese agronomic


practices so as to give rise to an impact under the NHPA.


9. The degree to which the action may adversely affect an endangered or threatened species
or its habitat that has been determined to be critical under the Endangered Species Act of
1973.
As described in Chapter 6 ofthe EA, APHIS has analyzed the potential for effects from
cultivation ofMON 87460 and its progeny on federally listed threatened and endangered
species (TES) and species proposed for listing, as well as designated critical habitat-and
habitat proposed for designation, as required under Section 7 of the Endangered Species
Act. After reviewing possible effects ofa determination ofnonregulated status ofMON
87460, APHIS has concluded that a determination ofnonregulated status ofMON 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.


10. Whether the action threatens a violation ofFederal, State, or local law or requirements
imposedfor the protection ofthe environment.
The proposed action would be in compliance with all federal, state, and local laws.
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 ofthe PP A, the regulations codified in 7 CFR part 340, and the
biotechnology regulatory policies in the Coordinated Framework. 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 ofthe FDA 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). There are no other Federal,
state, or local permits that are needed prior to the implementation ofthis action.


NEPA Decision and Rationale


I have carefully reviewed the EA prepared for this NEP A determination and the input from the
public involvement process. I believe that the issues identified in the EA are best addressed by
selecting Alternative 2 (Determination that MON 87460 is No Longer a Regulated Article). This
alternative meets APHIS' purpose and need to allow the safe development and use of genetically
engineered organisms consistent with the plant pest provisions ofthe Plant Protection Act.
As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the
agency believes would fulfill its statutory mission and responsibilities, giving consideration to
economic, environmental, technical and other factors." The preferred alternative has been


16

selected for implementation based on consideration of a number ofenvironmental, regulatory,
and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1)
it allows APHIS to fulfill its statutory mission to protect America's agriculture and environment
using a science-based regulatory framework that allows for the safe development and use of
genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations.
As APHIS has not identified any plant pest risks associated with MON 87460, the continued
regulated status ofMON 87460 would be inconsistent with the plant pest provisions ofthe PPA,
the regulations codified at 7 CFR part 340, and the biotechnology regulatory policies in the
Coordinated Framework. For the reasons stated above, I have determined that a determination of
nonregulated status ofMON 87460 will not have any significant environmental effects.


Michael C. Gregoire Date:
Deputy Administrator
Biotechnology Regulatory Services
Animal and Plant Health Inspection Services


U.S.

Department of Agriculture
Literature Cited:


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


Barker, T., Campos, H., Cooper, M., Dolan, D., Edmeades, G., Habben, J., Schussler, J., Wright,
D., & Zinselmeier, C. (2005). Improving drought tolerance in maize. In J. Janick (Ed.), Plant
Breeding Reviews (Vol. 25): John Wiley and Sons, Inc


Boyer, J. S. (1982). Plant productivity and environment. Science, 218(4571),443.


FDA. (2010). List of Completed Consultations on Bioengineered Foods. United States Food and
Drug Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland,


January 2011, from http://www.fda.gov/Food/Biotechnologv/Submissions/default.htm
Monsanto (2010). Petition for the Determination ofNonregulated Status for MON 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See Table


http://www.aphis.usda.gov/biotechnology/not reg.html).
USDA-APHIS. (2010). Plant Pest Risk Assessment for MON 87460 Corn. (Biotechnology
Regulatory Service). Riverdale, MD: APHIS - Animal and Plant Health Inspection Service.


17

USDA-ERS. (2010). Adoption of Genetically Engineered Crops in the U.S.: Corn Varieties
Retrieved Aug. 11 2010, from


http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTablel.htm
USDA-ERS. (20 1 Oa). Agricultural Projections to 2019.

USDA-ERS. (2011). USDA Agricultural Projections to 2020.

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

Yu and Babcock, B. (2010). Are U.S. Corn and Soybeans Becoming more Drought T01erant?


StaffGeneral Research Papers: Iowa State University.


18

Finding of No Significant Impact
Response to Comments
Petition 09-055-01p


On May 11, 2011, APHIS published a notice in the Federal Register (76 FR 27303-27304,
Docket no. APHIS-20 11-0023) announcing the availability of the Monsanto petition, and the
APHIS PPRA and draft EA for a 60-day public review and comment period. Public comments
were initially solicited for a 60-day public comment period ending July 11, 2011; however,
APHIS extended the public comment period for an additional 30 days (76 FR 44892-44893,
docket number APHIS-20 11-0023). Comments were required to be received on or before
August 12,2011.


APHIS received a total of250 comments from various individuals and groups on the MON87460
corn petition, PPRA, and draft EA. The majority ofthe comments (229) opposed the
development and use of genetically engineered foods and/or MON87460 corn, while 21
comments supported a determination ofnonregulated status of MON87460 corn. Public
comments included individual submissions, form letters, and various electronic media
encompassing both the peer-reviewed and non-peer-reviewed literature.


Twenty-one public comments supporting a determination ofnonregulated status ofMON87460
corn were submitted from private citizens, farmers routinely affected by drought, agribusiness
associations, corn grower associations, and state agriculture departments. Those individuals
cited several salient points regarding the potential benefits ofMON 87460 corn, including:

1)
a
capacity to alleviate the risk of reduced corn grain yields in areas susceptible to drought; 2)
increased economic benefit for consumers, processers, and growers due to more stable corn grain
yields; and 3) the utilization of another tool for American corn growers to meet an increasing
global demand for com grain.


Those 229 public comments received opposing a determination of nonregulated status of
MON87460 com were submitted by individuals and Non-Government Organizations (NGO). Of
these NGOs, three submitted electronic attachments that consisted either of: a) a single letter
signed by numerous people (6,335 signatures); b) many letters containing identical material
(16,742 letters); or c) a consolidated document of comments (22,500). Many ofthese public
comments expressed a general opposition to genetically modified organisms (GMOs) or GE
crops and the domestic regulatory process surrounding GE plants; perceived negative effects on
public and animal health, biodiversity, and the environment; and a lack of consideration
regarding organic production systems and the public right to choose non-GE containing food
products. The majority ofthese public comments did not explain or identify elements in the
MON87460 com PPRA or EA that were perceived to be inadequate or provide any supporting
evidence for their claims. Several specific issues related to the MON87460 EA were, however,
identified from the collective pool of public comments and form letter submissions. These were
organized into categories and addressed below.


19

Public comments and Responses


Comment
1:
Several commenters expressed a general disapproval of GE plants for non­
cited reasons related to health and the environment; additionally, several comments voiced
concern that an Environmental Assessment (EA) was insufficient for MON87460 corn and
that an Environmental Impact Statement (EIS) should be prepared to inform any decision
regarding a determination of non regulated status of MON87460 corn. Concerns were also
raised in response to a perceived APHIS reliance on Monsanto data throughout the
MON87460 EA. Several commenters voiced support for a moratorium on GE plants by
the agency.


Response
1:
APHIS recognizes that some citizens are opposed to genetic engineering offood
crops. As discussed in Chapter 1 of the EA, the basic charge of APHIS is to protect American
agriculture through improvements in agricultural productivity and competitiveness, and
contributions to the national economy and the public health. APHIS asserts that all methods of
agricultural production (conventional, organic, or the use of genetically engineered (GE)
varieties) can provide benefits to the environment, consumers, and farm income.


Since 1986, the United States government has regulated GE organisms pursuant to a regulatory
framework known as the Coordinated Framework for the Regulation ofBiotechnology (51 FR
23302,57 FR 22984) (Chapters 1.1; 1.2; and 1.6 of the EA). As described in Chapter 1.2 of the
EA, APHIS regulates the introduction (importation, interstate movement, or release into the
environment) of certain GE organisms and products under the authority ofthe plant pest
provisions ofthe Plant Protection Act and 7 CFR part 340. 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. Based on
scientific information and analysis provided in both the PPRA (USDA-APHIS, 2010) and EA,
APHIS has concluded that MON 87460 does not pose a plant pest risk and will not significantly
impact the quality ofthe human environment, respectively. Due to the lack of significant
impacts as presented in the FONSI, an EIS for a determination of nonregulated status of
MON87460 com is not necessary.


APHIS relied on a variety of sources to support its analysis ofthe potential impacts of a
determination of nonreguI ated status ofMON87460 including those pertaining to health and the
environment. These sources included, but are not limited to the Monsanto petition, Federal
agencies (e.g., USDA-ERS, USDA-NASS, and FDA), academic datasets
(

http://www.prism.oregonstate.edu). and peer-reviewed literature. The analyses in the EA
utilized a variety of sources in addition to the MON87460 petition. A complete list of references
used to support development of the EA can be viewed in the bibliography located in Chapter 8 of
the EA.
APHIS rejects the proposal for a moratorium on the commercialization ofMON87460 and GE
plants in general. Such an approach would contradict the national policy as described in the


Coordinated Framework for the Regulation of Biotechnology (51 FR 23302,57 FR 22984),
which states that the mere fact of using genetically engineering to modify an organism does not


20

mean that the organism necessarily poses a greater risk. Rather, the regulatory approach focuses
on the characteristics of the organism or product, and how the organism or product is to be used.


References
USDA-APHIS (2010) Plant Pest Risk Assessment for Mon 87460 Com. Riverdale, MD: APHIS


-Animal and Plant Health Inspection Service. Retrieved from


http://www.aphis.usda.gov/biotechnologv/not reg.html
Comment 2: Several commenters claimed that APHIS failed to consider geographic
isolation as an Alternative, since the target range of MON87460 corn is the western


dryland Great Plains region. Additionally, several commenters claimed that APHIS
generally failed to consider the benefits of organic corn or biodynamic production systems
as an Alternative in the EA.


Response 2: The EA was been prepared in order to specifically evaluate the potential effects on
the quality of the human environment that may result from a determination of nonregulated
status of MON87460 com. APHIS assembled a list of alternatives that might be considered for
MON87460. 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 MON87460. As described in Chapters 3.1 and 3.2 of the EA, APHIS
evaluated two alternatives; (1) no action and (2) determination of nonregulated status of
MON87460 in the environmental consequences section ofthe EA (Chapter 4). In addition,
APHIS rejected several other alternatives. These alternatives are discussed briefly in Chapter 3.3
of the EA along with the specific reasons for rejecting each.


As described in Chapter 3.3.3 ofthe EA, Geographic Restriction was rejected as an Alternative
and not analyzed in detail because APHIS concluded that MON87460 does not pose a plant pest
risk, and will not exhibit a greater plant pest risk in any geographically restricted area.
Consequently, a Geographic Restriction 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;
furthermore, the imposition of 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.


APHIS did not consider the general nature of organic agriculture and similar systems as an
alternative in the EA because the nature or use oforganic agriculture is not within the scope of
analysis ofthis EA or APHIS regulatory decision in response to Monsanto's petition request for
MON87460 com. The EA was been prepared in order to specifically evaluate the potential
effects on the quality of the human environment that may result from a determination of
nonregulated status of MON87460 com. The potential impacts of APHIS' regulatory decision
with respect to non-OE, organic and specialty com production systems are presented in Chapters


2.1.2 and 4.3 of the EA.


21

Comment 3: Several commenters suggested that the Cumulative Impacts Analysis ofthe
MON87460 EA was inadequate in that the stacking of GE traits was not discussed.


Response

3:
APHIS disagrees that the Cumulative Impacts sections in the EA was inadequate.
However, in order to further organize and clarify the Cumulative Impacts analysis in the EA,
individual Cumulative Impact sections that were presented in Chapter 4 of the draft EA have
been consolidated and rewritten as Chapter 5 in the final EA. APHIS directs readers and
commenters to Chapter 5 of the EA for any further discussion.


Comment 4: Several comments expressed concern regarding the potential rejection of
MON87460 corn produced in the L.S. by certain foreign markets that have not approved
MON87460 corn for import.


Response 4: Key nations and governments that import U.S. corn include Japan, Canada, Mexico,
and the European Union (EU). Import requirements for the major U.S. corn-importing nations
are listed in Chapter 2.6.1 and Chapter 4.8.2 ofthe EA. As stated in the Monsanto petition
(Chapter X.C.1.4) and Chapter 4.8.2.2 ofthe EA, the Monsanto Company does not intend to
enter MON87460 corn into commercial production within the U.S. until all major U.S. corn­
importing nations and governments with functioning regulatory systems also grant approval of
MON87460 corn (Monsanto, 2010b). Some nations and governments are not presently major
importers of U.S. corn, though some are steadily increasing import of U.S. corn (e.g., China)
(USDA-ERS, 2011). Of the many GE varieties of corn currently grown by farmers, many are
approved for import into other countries, but not all have been approved to all countries (e.g.,
China). When farmers choose to grow a GE variety of corn, the approval status in foreign
countries should be of major concern (NCGA, 2011). The importance ofthis issue is well
known to farmers, distributors, and exporters, because trade disruptions over non approved
varieties have been experienced by the industry (Marvier and Acker, 2005). Corn growers
associations, such as the National Corn Growers Association (NCGA) provides guidance for GE
corn grain production of events that are not approved in certain countries. In short, this guidance
suggests that individual growers 1) feed livestock on their own operations with the unapproved
events; 2) find domestic livestock feeding channels; and 3) identify grain elevators that accept
corn grain varieties that are not approved by other countries and nations (NCGA, 2011).
Monsanto is committed to product stewardship, and for its current line of Genuity corn products,
notes that "This product has been approved for import into key export markets with functioning
regulatory systems. Any crop or material produced from this product can only be exported to, or
used, processed or sold in countries where all necessary regulatory approvals have been
granted...Growers should talk to their grain handler or product purchaser to confirm their buying
position for this product" (Monsanto, 201 Oa, 2011).


Corn purchasing and processing facilities employ quality control processes to assure buyers that
the products produced using specialty corn will be usable for specific end products and


destinations. Before commercialization, Monsanto has agreed to make available a detection
method for MON87460 corn to grain producers, processors, and buyers in order to control the
adventitious presence of non-approved GE traits (Monsanto, 2010b). A determination of


nonregulated status of MON87460 corn is unlikely to significantly impact these mechanisms.


22

References


Marvier M and Acker RCV. (2005) Can Crop Transgenes Be Kept on a Leash? Frontiers in


Ecology and the Environment, 3(2), 99-106.
Monsanto (20IOa) Monsanto Technology/Stewardship Agreement. The Monsanto Company.
Monsanto (20l0b) Petition for the Determination ofNonregulated Status for Mon 87460.


Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://www.aphis.lIsda.gov/biotechnology/not reg.html).


Monsanto (2011) Genuity Com and Soybean Trait Products Lineup Expanded for 20 II. The
Monsanto Company. Retrieved November, 2011 from


http://monsanto.mediaroom.comI20 II-genuitv-com-soybean-product-1 ineup


NCGA (2011) Know before You Grow. National Com Growers Association. Retrieved


October, 2011 from http://www.ncga.com/know-before-voll-grmv!


USDA-ERS. (2011) Feed Grains Database - Custom Query. Retrieved October, 2011 from
United States Department ofAgriculture - Economic Research Service


http://www.ers.lIsda.gov/data/feedgrains/CustomOllcrv!Dcfault.aspx


Comment 5: Several commenters claimed that the drought-tolerance of MON87460 corn is
unsupported by field trials, emphasizing that MON87460 yield was 9 percent lower than
the control under water-limited conditions in its target range and that the MON87460 trait
reduced grain yield by ten percent under well-watered conditions. Additionally, several
comments also claimed that APHIS did not discuss conflicting reports from independent
sources regarding the poor performance of MON87460 under well-watered conditions. A
single comment also claimed that Monsanto did not publish its experimental method.


Response 5: APHIS does not agree that the drought-tolerance of MON87460 is unsubstantiated.
As mentioned in Chapter 4.3.2.2 ofthe EA, MON87460 is not intended to eliminate or reduce
the need for irrigation over the cultivation period of corn; rather, it is intended to provide a buffer
against yield loss during periods of drought stress. While the yield of MON87460 under suitable
water-limited conditions does not exceed that ofthe reference variety range, yield is generally
improved relative to its control variety. For example, MON87460 yields were significantly
higher than its respective control in combined-site analysis of 2006/2007 Chilean field studies.
Under water-limited conditions, both 2007 split plot and strip plot studies demonstrate that
MON87460 possessed higher grain yield than its respective control (7.5 and 35.2 percent greater
yield, respectively) (Table Rl). Both of these sites, while not statistically significant,
demonstrated a general increased yield trend of MON87460 corn relative to its respective control
com variety under water-limited conditions and a not a 9 percent decrease.


23

Table R1. Comparison of grain yield between MON87460 corn and its control in Great
Plain states.


Design Site
Water-Limited
MON87460
1
Split Plot TX
Control
I
Split Plot TX
MON87460
2
Strip plot TX
Controf Strip plot TX
Water-sufficient
MON87460
3
Split Plot TX
Controe Split Plot TX
MON87460
4
RCB KS+NE
Control
4
RCB KS+NE
MON87460
5
RCB NE
Control
5
RCB NE
MON87460
6
Strip plot KS+"N'E+TX
Control
6
Strip plot KS+NE+TX
Yield % difference in
Year (bushels/acre) MON87460 yield
2007 186 + 7.5
2007 173.1
2007 228.3 + 35.2
I
2007 168.8
2007 215.4 -1.69
2007 219.1
2006 164.1 -6.7
2006 175.9
2007 . 156.4 -0.07
2007 156.5
2007 192.3 + 3.05
2007 186.6
1
Table F-19 ofthe MON87460 petition.
2
Table VITI-II ofthe MON87460 petition.

::I
Table F-18 ofthe MON87460 petition.
4
Table F-14 ofthe MON87460 petition.
sTable F-15 ofthe MON87460 petition.
6
Table F20 ofthe MON87460 petition.

APHIS also disagrees that MON87460 com yielded 10 percent less grain than its respective
controls under well-watered conditions in Great Plains states. It should be noted that the
commenter did not describe how the 10 percent value was calculated. In Table Rl, while the
2007-TX split plot and the 2006-KS and NE randomized complete block (RCB) studies showed
a decreased MON87460 grain yield relative to its control (-1.69 and -6.7 percent, respectively),
other studies demonstrated that grain yields of MON87460 com are near identical (2007-NE
RCB study: -0.07 percent) or greater (2007-KS, NE, and TX strip plot study: 3.05 percent) than
its respective control in the tested Great Plains states. Despite the direction of these differences,
the magnitude of differences was not statistically significant. Thus, across time and site
locations, MON87460 com grain yield is comparable to its respective control under water­
sufficient conditions in the Great Plains states.


Additionally, with respect to the claim that APHIS did not review independent sources regarding
the performance of MON87460 com under conditions of normal precipitation, APHIS is unable
to find any independent reviews of MON87460 in the literature. Even the example provided by
the commenter cannot confirm that it is MON87460 that is being discussed ("He stated: -The
flaw is a profound one. It amounts to shifting the yield losses experienced in dry seasons onto the
good years. While it is not clear from the article whether that variety is the same event as MON
87460...").


24

With regard to the claim that Monsanto did not publish its experimental design, this is explained


in Chapter VIII ofthe MON87460 petition.


References


Monsanto (2010) Petition for the Determination ofNonregulated Status for MON 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See Table


http://w..

vw.aphis.llsda.gov/biotechnology/notreg.htm))


Comment 6: Several commenters expressed concern that a determination of nonregulatory
status of MON87460 corn and other GE crops allows for the creation of corporate food
monopolies.


Response 6: APHIS acknowledges the comments. Although APHIS recognizes that new
technologies developed and owned by a private firm have the potential to lead to increased
market concentration when introduced in the market, introduction of new technologies or
increased market concentration do not in themselves lead to unfair competition. Fair competition
and business practices are enforced through United States anti-trust laws and institutions and are
beyond the scope ofthis EA.


Comment 7: Several comments expressed concern regarding the plant pest risk of
MON87460 corn, including the potential to hybridize with sexually-compatible relatives to
produce progeny plants with weedy characteristics. Additionally, a specific reference was
made to the root lodging of MON87460 corn in one field trial location and its implication
with increased plant weediness.


Response 7: MON 87460 com was produced by transformation of com tissue using
Agrobacterium tumefaciens to introduce the nptIl (neomycin phosphotransferase II) and cspB
(cold shock protein B) genes (as described in Appendix A ofthe EA). Consequently,
MON87460 com was considered a regulated article under APHIS regulations at 7 CFR part 340.
Part 340 regulates, among other things, the introduction of organisms and products altered or
produced through genetic engineering which are plant pests or which there is reason to believe
plant pests. Under 7 CFR part 340 and in response to the Monsanto Company MON87460
petition, APHIS prepared a Plant Pest Risk Assessment (PPRA) and published it in conjunction
with the MON87460 Environmental Assessment (EA). APHIS concluded that MON87460 does
not pose a plant pest risk and is unlikely to be any more invasive than currently available
varieties of com (USDA-APHIS, 2010).


The Monsanto Company collected agronomic data from numerous MON87460 studies (field,
greenhouse, and laboratory) with respect to composition; 14 plant growth and development
characteristics, five seed germination parameters, two pollen characteristics; plant response to
abiotic stressors; and several observations on plant-insect and plant-disease interactions
(Monsanto, 2010). No significant and consistent differences were observed between MON87460
com and its control with regard
to
seed germination and pollen characteristics, response to
abiotic stresses, and plant-insect/disease responses. From six field studies totaling 31 sites across
two years, very few unexpected statistically significant differences were observed in combined


25

site analyses with regard to phenotypic characteristics (i.e., 14 plant growth/development
characters and five seed germination characters) indicative of increased weediness between
MON87460 corn and control plants. A statistically significant measurement increase in root
lodging was observed in one year (Table VIII-4 of the MON87460 petition) and was not
observed in other years (Monsanto, 2010). This observation, along with other statistically
significant measurements were always within the reference range ofother corn varieties, strongly
suggesting that the observed measurements were typical variations for corn behavior in the same
field trials and not increased plant weediness.


APHIS also evaluated the potential for introgression to occur from MON87460 to sexually
compatible wild relatives and considered whether introgression, if it were to occur, would result
in increased weediness in the MON87460 PPRA. Cultivated corn (MON87460 included) is
sexually compatible with several members of the genus Zea (e.g., teosinte), and to a much lesser
degree, members of the genus Tripsacum. As described in the Chapter 4.5.4 of the EA, the
likelihood of gene flow between MON87460 and teosinte due to differences in flowering
phenology, current and expected geographic separation, and genetically based cross­
incompatibility systems (Baltazar et aI., 2005; Doebley, 1990a, 1990b; Ellstrand et aI., 2007;
Galinat, 1988; Kermicle and Evans, 2005). Additionally, hybridization between corn and
Tripsacum is not likely in the absence of specialized hybridization techniques in controlled
conditions, strongly suggesting that hybridization is unlikely in typical field conditions (Galinat,


1988; Mangelsdorf, 1974; Russell and Hallauer, 1980). Furthermore, none ofthe sexually
compatible relatives of corn in the U.S. are considered to be weeds in the U.S. (Holm et aI.,


1979). Therefore, even in those instances of accidental gene flow between MON 87460 corn and
wild relatives, the transgenes ofMON 87460 corn are unlikely to transform corn wild relatives
into more weedy species.


References
Baltazar B, de Jesus Sanchez-Gonzalez J, de la Cruz-Larios L, and Schoper J. (2005) Pollination


between Maize and Teosinte: An Important Determinant of Gene Flow in Mexico. TAG


Theoretical and Applied Genetics, 110(3), 519-526.
Doebley J. (1990a) Molecular Evidence for Gene Flow among Zea Species. BioScience, 40(6),


443-448.
Doebley J. (1990b) Molecular Systematic of Zea (Gramineae). Maydica, 35, 143-150.
Ellstrand NC, Garner LC, Hegde S, Guadagnuolo R, and Blancas L. (2007) Spontaneous


Hybridization between Maize and Teosinte. Journal ofHeredity, 98(2), 183.
Galinat W. (1988) The Origin of Corn. In GF Sprague and JW Dudley (Eds.), Com and Com


Improvement (pp. 1-27). Madison, WI: American Society of Agronomy, Inc., Crop Soil


Science Society of America, Inc., and the Soil Science Society of America, Inc.
Holm L, Pancho J, Herberger V, and Plucknett DL. (1979) A Geographical Atlas of World
Weeds. 471-04393.
Kermicle J and Evans M. (2005) Pollen-Pistil Barriers to Crossing in Maize and Teosinte Result
from Incongruity Rather Than Active Rejection. Sexual Plant Reproduction, 18(4), 187­


194.
MangelsdorfPC. (1974) Com: Its Origin. Evolution, and Improvement. Harvard University
Press Cambridge, MA.


26

Monsanto (2010) Petition for the Determination ofNonregulated Status for Mon 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://www.aphis.usda.govlbiotechnology/notreg.htm!).
Russell WA and Hallauer AR. (1980) Corn. In WR Fehr and HH Hadley (Eds.), Hybridization of
Crop Plants (pp. 302). Madison, WI: American Society of Agronomy and Crop Science
Society of America.


USDA-APHIS (2010) Plant Pest Risk Assessment for Mon 87460 Corn. Riverdale, MD: APHIS
- Animal and Plant Health Inspection Service. Retrieved from


http://wW\V.aphis.usda.gov/biotechnologv!notreg.html


Comment 8: Several commenters expressed concern regarding a 22 nucleotide deletion at
the plant/insert junction of the

T

-DNA cassette. Additionally, concern was also raised
regarding any residual Agrobacterium tumefaciens in MON87460 following transformation.


Response 8: With regard to the 22 nucleotide deletion at the plant/inset junction ofthe T-DNA
cassette in MON87460, the commenters did not state the reasoning behind this concern. The
potential for small localized deletions at the site of T -DNA integration following Agrobacterium­
mediated transformation is well a known-phenomena and is only detrimental if a negative
phenotype is produced (Bundock and Hooykaas, 1996). In spite of this 22 nucleotide deletion,
genetic stability ofthe insert was not negatively affected; furthermore, agronomic, forage, or
grain compositional analysis was not negatively affected, suggesting that this 22 nucleotide
deletion did not disrupt an essential gene required by corn (USDA-APHIS, 20 I 0).


Additionally, APHIS concluded that no residual A. tumefaciens remained in MON87460 corn, as
the use of carbenicillin (Monsanto, 2010) during the corn callus regeneration process effectively
eliminates A. tumefaciens (Opabode, 2006).


References


Bundock P and Hooykaas PJJ. (1996) Integration ofAgrobacterium Tumefaciens T-DNA in the
Saccharomyces Cerevisiae Genome by IJIegitimate 0 Recombination. Proceedings ofthe
National Academy ofSciences, 93(26), 15272-15275.


Monsanto (2010) Petition for the Determination ofNonregulated Status for Mon 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://www.aphis.usda.gov/bIoteehnology/notreg.htm!).
Opabode J. (2006) Agrobacterium-Mediated Transformation of Plants: Emerging Factors That
Influence Efficiency. Biotechnology and Molecular Biology Reviews, 1(1), 12-20.


USDA·APHIS (2010) Plant Pest Risk Assessment for Mon 87460 Corn. Riverdale, MD: APHIS
- Animal and Plant Health Inspection Service. Retrieved from


http://Vo/\vw.aphis.usda.gov/biotechnologv!not

reg.h1m

1


Comment 9: A comment expressed concern regarding honey bee Colony Collapse Disorder
(CCD) and genetically engineered crops like MON87460 corn.


Response 9: Honey bees (Apis mellifera), the only bee species commercially maintained in the


U.S. function as vital pollinators of a variety of agricultural crops. First observed on the eastern
27

U.S. coast in the second half of 2006, honey bee Colony Collapse Disorder accounted for a
decl ine of approximately 36 percent ofthe honey bee population (Johnson, 20 I 0). In contrast to
other previous bee colony losses, CCD can be distinguished by several unusual attributes,
including:

1)

failure of adult worker bees to return to the hive, despite the presence of a brood
and queen remaining in the hive; 2) relatively wide-spread and rapid colony loss throughout the
entire year (i.e., not seasonal); and 3) that the mechanisms ofthe loss still remain unknown.
Possible causes of CCD include pathogens, parasites, environmental stresses, and bee
management stresses (e.g., poor nutrition); however, recent evidence suggests that CCD may
represent a syndrome caused by a suite of factors interacting synergistically to produce rapid and
wide-spread colony collapse (USDA, 2009). Potential biotic and abiotic stresses correlated with
CCD include, but may not be limited to: the single-celled parasite Nosema ceranae; Israeli acute
paralysis virus (IAPV) and its potential vector, the Varroa mite; or neonicotinoid, a synthetic
insecticide derived from nicotine (Johnson, 2010). Indeed, a recent publication demonstrated
increased honey bee mortality due to the synergistic interaction between N ceranae infection
and sublethal exposure to the insecticides fipronil or thiacloprid (Vidau et ai., 20 II). It is
prudent to observe, however, that correlation does not equal causation; consequently, while
several factors have been observed to be strongly correlated with CCD, it is not known whether
anyone ofthese products is the cause ofCCD.
A consultation with FDA with successfully completed for both NPTn and CSPB proteins in
MON87460 com (Appendix A of the EA), demonstrating a lack ofatoxicity and allergenicity for
human and animal consumption. MON87460 corn, like all com cuitivars, does not produce
nectar. Thus, foraging honey bees would only collect com pollen. Mon87460 expresses both
nptII and cspb

in

a variety of plant tissues, pollen included. As discussed in Chapter 4.5.1.2 and
Chapter 4.6.1.2 of the EA, both NPTn and CSPB are not expected to have any negative effect on
non-target organisms. The safety of NPTII has been addressed

in

multiple publications and has
been granted an exemption from the requirement of tolerance for use as a selectable marker in
raw agricultural commodities (40 CFR Part 180.1134) (EFSA, 2004; Fuchs et ai., 1993a; Fuchs
et aI., 1993b; Nap et aI., 1992). In regard to CSPB, it is not expected to affect non-target
organisms through toxicity. The donor organism for CSPB, Bacillus subtilis, is not pathogenic,
has a history of safe use, and its enzyme preparations (containing CSPB) are generally
recognized as safe by the Food and Drug Administration (FDA) (FDA, 1999,2010).


References


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


Plants. Scientific Opinion ofthe Panel on Genetically Modified Organisms (Gmo) and


the Panel of Biological Hazards (Biohaz). EFSA Journal( 4), 1-18.
Carbohydrase and Protease Enzyme Preparations Derived from Bacillus SubtiUs or Bacillus
Amyloliquefaciens; Affirmation of Gras Status as Direct Food Ingredients, FDA.
FDA (2010) List of Completed Consultations on Bioengineered Foods. United States Food and


Drug Administration, Center for Food Safety and Applied Nutrition, College Park,


Maryland. United States Food and Drug Administration. Retrieved January 2011 from


http://\vww.fda.gov/Food/BiotechnologyiSubrnissiol1s/default.htm
Fuchs R, Heeren R, Gustafson M, Rogan G, Bartnicki D, Leimgruber R, Finn R, Hershman A,
and Berberich S. (1993a) Purification and Characterization of Microbially Expressed


28

Neomycin Phosphotransferase Ii (Nptii) Protein and Its Equivalence to the Plant
Expressed Protein. Nature Biotechnology, 11(12), 1537-1542.


Fuchs RL, Ream JE, Hammond BG, Naylor MW, Leimgruber RM, and Berberich SA. (1993b)
Safety Assessment of the Neomycin Phosphotransferase Ii (Nptii) Protein. Nature
Biotechnology, 11(12), 1543-1547.


Johnson R (20 I0) Honey Bee Co lony Collapse Disorder. Congressional Research Service.
Retrieved April 2011, from


http://books.google.com/books'?ici=SxaJTt3KgoEC&lpg=PPI&dq=Honey%20bee%2OcoI
onv%20collapse%20di sorder&pg=PP 1#v=onepage&q&f=false.
Nap J-P, Bijvoet J, and Stiekema W. (1992) Biosafety of Kanamycin-Resistant Transgenic
Plants. Transgenic Research, 1(6),239-249.
USDA (2009) Colony Collapse Disorder Progress Report. CCD Steering Committee. Retrieved
March 20 11,

from http://www .ars.usda.gov lis/br/ccd/ccdprogressreport.pdf


Vidau C, Diogon M, Aufauvre J, Fontbonne R, Vigues B, Brunet J-L, Texier C, Biron DG, Blot
N, EI Alaoui H, Belzunces LP, and Delbac F. (2011) Exposure to Sublethal Doses of
Fipronil and Thiacloprid Highly Increases Mortality of Honeybees Previously Infected by
Nosema Ceranae. PLoS One, 6(6), e2I550.


Comment 10: A commenter claimed that APHIS failed to comply with the Endangered
Species Act (ESA) by not consulting other Federal agencies on impacts to Threatened and
Endangered Species.


Response 10: The Endangered Species Act (ESA) of 1973, as amended, is one ofthe 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 ofAmerica's heritage. 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 oftheir action and to consult with the USFWS and NMFS if it is determined that the
action "may affect" listed species or critical habitat. APHIS follows USFWS procedures required
by the agency, and those specifically agreed upon by USFWS for APHIS to follow, thus
fulfilling their obligations and responsibilities under Section 7 of the ESA for permit- and
petition-related regulatory actions. APHIS disagrees with the claim that APHIS failed to comply
with the ESA. As detailed in Chapter 6 ofthe EA, APHIS concluded after an environmental
review that a determination of nonregulated status of MON87460 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, because of
this conclusion, consultation with the United States Fish and Wildlife Service (USFWS) or
National Marines Fisheries Service (NMFS) was not required for that action.


29

Comment 11: Several commenters claimed that a determination of nonregulated status of
MON87460 corn would directly lead to a significant increase in U.S. corn acreage,
negatively impacting enrollment of land in the Conservation Reserve Program (CRP).
Additionally, a commenter claimed that APHIS failed to look at regional impacts of the
conversion of CRP land to intensive corn production, citing a study by Brooke et al (2009)
examining the Prairie Pothole Region as an example of this difference.


Response 11: APHIS acknowledges that there will be a small increase in domestic corn
cultivation acreage, as this increase is supported by existing land-use decisions for agricultural
commodities and projected trends for U.S. corn production (USDA-ERS, 20 II a, 20 II b).
However, APHIS disagrees that a determination ofnonregulated status of MON87460 corn will
directly increase U.S. corn acreage. Additionally, APHIS also disagrees with the contention that
a determination ofnonregulated status of MON87460 corn will reduce enrollment ofland in the
CRP.


It is well established that market forces and government policies are the two primary factors
associated with increased U.S. corn production (Claassen and Tegene, 1999; Plantinga et aI.,
200 I; Secchi et al., 20 II; USDA-ERS, 201Ia). Increased domestic demand for corn ethanol and
increased international demand for livestock feed represent two existing and continuing
economic forces stimulating corn production (Secchi et al., 2009; USDA-ERS, 2009; USDA,
2009b). Additionally, ethanol tax credits (e.g., Ethanol Excise Tax Credit [VEETC]), increased
funding for federal land-use programs (e.g., Working-Land Conservation Programs), and
decreased funding for conservation programs (e.g., the decrease of the overall CRP land
enrollment) (Brooke et aI., 2009; USDA-ERS, 2011a; USDA-FAS, 2011) represent government
policies enacted to satisfy current and projected demand for U.S. agricultural commodities such
as corn grain. Collectively, these external market forces and federal policy decisions incentivize
corn cultivation, leading to baseline increases in corn grain production as concluded by academic
studies (Donner and Kucharik, 2008; Solomon et aI., 2007), government reports (USDA-ERS,
2011 a, 20 II b; USDA, 2009a), and even the commenter himlherself ("Recently, government
incentives for ethanol production have led to dramatic increases in corn production;" "This has
led to an increase in both corn demand and prices;" "High corn prices ...The primary reason
farmers take their land out of CRP is economic"). It is worth noting, however, that despite these
synergistic factors that facilitate and sustain increased domestic corn production, the majority of
land for increased corn cultivation is derived from other crops, such as wheat and soybean, and
not at the expense of novel land conversion (USDA-ERS, 20 II b). It is also worth noting that
these existing factors, directly responsible for recent trends in increased corn production,
occurred independently of the regulatory status ofMON87460 corn. In order for a determination
ofnonregulated status of MON87460 corn to discourage CRP land enrollmentlreenrollment and
increase net corn acreage beyond baseline rates/projections based on the current agricultural and
economic environment, MON87460 corn would have to provide a farmer with some incentive
beyond those already available with conventional corn varieties. Incentives include corn
attributes that enable cultivation on marginal land, decrease farm cost typically associated with
corn cultivation, or significantly increase grain yield beyond currently-available and


30

commercialized corn hybrid varieties. As demonstrated in the Monsanto petition and APHIS
analysis, MON87460 corn requires similar management conditions and does not possess
increased salt, heat, and cold tolerances, thus precluding any reasonable expectation that it is
more likely to be cultivated on CRP or marginal lands or result in reduced operating costs
relative to conventional corn varieties. Additionally, while MON87460 corn is designed to
exhibit a reduced yield-loss phenotype relative to its nontransgenic parent variety under water­
limiting condition, the magnitude of the MON87460 phenotype is within the natural range of
variation of commercial corn hybrids under both water-sufficient/limited conditions, strongly
suggesting that cultivation of MON87460 corn is unlikely to provide grain yield benefits beyond
what is already available with currently-commercialized corn varieties. This EA was not written
to assess the general causes of increased corn cultivation or speculate on general trends related to
CRP land enrollment; it was written to determine if a determination of nonregulated status of
MON87460 would significantly impact the quality ofthe human environment, such as enabling
the expansion of corn acreage beyond what is already available with current corn varieties. As
illustrated above, the primary factors directing U.S. corn production occurred and are occurring
independently of the regulated status of MON87460 corn. Additionally, MON87460 is not any
more likely to be cultivated on CRP/marginalland than conventional corn varieties, nor does its
agronomic performance deviate beyond the range of natural variation currently present in
commercial corn hybrids. What MON87460 does provide is reduced grain loss relative to its
comparator under water-limiting conditions. Thus, based on these two conclusions, a
determination of nonregulated status of MON87460 is unlikely significantly increase corn
acreage or decrease CRP enrollment beyond what is already occurring. Chapters 2.1.1, 4.3.1.1,
4.3.1.2, and 4.5.1.2 of the EA have been rewritten to better illustrate this relationship between
existing trends in corn acreage, external market forces, and government policies that directly
affect agricultural commodities. Furthermore, those chapters ofthe EA have been rewritten to
clarify APHIS' analysis that a determination of non regulated status of MON87460 corn is
unlikely to significantly impact U.S. corn acreage and CRP land enrollment. APHIS directs
readers and commenters to those rewritten sections for discussions ofthese two issues.


APHIS disagrees with the comment that claimed a failure of APHIS to analyze both regional and
national impacts on CRP land conversion following a determination of nonregulated status of
MON87460, and the implication that these impacts would differ significantly on the regional and
national scales. Firstly, APHIS disagrees with the commenter contention that the study by
Brooke et al. (2009) reports a significant environmental impact resulting from the conversion of
CRP land into corn production in the Prairie Pothole Region. As undertaken in Brooke et al.
(2009), the land-use change [change index] metric is calculated from corn acreage, CRP
enrollment, and conversion of grassland into agricultural production (when data was available).
Thus, any observed effect is due to those three factors collectively. For the commenter to
attribute any impact solely to CRP land conversion is erroneous, as the metric consists of three
factors and not one. Furthermore, the land-use change metric and its effects may be
overestimated because it takes into account net corn acreage but does not attempt to separate out
the effect of crop shifting, effectively equating shifts away from soybean/wheat on agricultural
land with conversion of novel land into agricultural production (Brooke et aI., 2009). This is
particularly relevant, as it is known that the majority of additional corn acreage comes at the
expense of other crops (USDA-ERS, 2011a, 2011 b). Secondly, the commenter assumes that any
31

national/regional CRP impact will be determined by the availability of a product (i.e.,
MON87460 com), once again citing the Prairie Pothole Region as an example. This contention is
false; as described in Chapters 2.1.1, 4.3.1.1, 4.3.1.2 ofthe EA, and Brooke et aL (2009), CRP
enrollment on both national and regional levels is ultimately influenced by economic forces and
government policy. However, ifthis were true, then CRP acreage trends would differ on
national and regional scales. As seen in Figure Rl, national and regional CRP trends generally
mirror each other. Also in Figure Rl, it can be observed that general increases/decreases in CRP
acreage on both national and regional scales follow CRP enrollment changes dictated by
successive Farm Bills (increase in 1990; decrease in 1996; increase in 2002; and decrease in
2008), providing an example of how government policy and not a particular com variety affects
CRP acreage. Additionally, ifthis commenter assumption were true, then national/regional
trends in CRP and com acreage would bear an inverse relationship, where an increase in com
acreage caused a decrease in CRP acreage. However, acreage trends from Figures RI and R2
demonstrate that this is not the case on both the national and regional scale; in the U.S. and the
Prairie Pothole Region, com and CRP acreage generally mirror each other (a trend also observed
in Figure 5 ofthe EA). These trends suggest that increases in com acreage do not come at the
expense of CRP land, but rather from other crops. This is confirmed by USDA-ERS data, where
only 2 percent of com-soybean farms converted land from CRP after a period of increased corn
production, with the rest derived from other crops (USDA-ERS, 2011a). This latter point can be
additionally observed in Figures R2 and R3, where national/regional increases in corn acreage
coincide with national/regional decreases in wheat (though com is not planted only at the
expense of wheat).


Issues of impacts on threatened and endangered species were analyzed by species (in their
specific regions of occurrence) and no impact was concluded.


Figure R1. US and Prairie Pothole Region CRP acreage


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32

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(USDA-FSA, 2011; USDA-NASS, 2011)


References


Brooke R, Fogel G, Glaser A, Griffin and Johnson K (2009) Corn Ethanol and Wildlife: How
Increases in Corn Plantings Are Affecting Habitat and Wildlife in the Prairie Pothole
Region. National Wildlife Federation.


Claassen Rand Tegene A. (1999) Agricultural Land Use Choice: A Discrete Choice Approach.
Agricultural and Resource Economics Review, 28(1),26-35.


Donner SD and Kucharik CJ. (2008) Corn-Based Ethanol Production Compromises Goal of
Reducing Nitrogen Export by the Mississippi River. Proceedings ofthe National
Academy ofSciences, 105(11),4513-4518.


Plantinga AJ, Alig R, and Cheng Ht (2001) The Supply of Land for Conservation Uses:
Evidence from the Conservation Reserve Program. Resources, Conservation and
Recycling, 31(3), 199-215.


33


Figure R2. US and Prairie Pothole Region Corn Acreage

- US Corn - "'" Pothole Corn


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Secchi S, Gassman P, Williams J, and Babcock B. (2009) Corn-Based Ethanol Production and
Environmental Quality: A Case of Iowa and the Conservation Reserve Program.
Environmental Management, 44(4), 732-744.


Secchi S, Kurkalova L, Gassman PW, and Hart C. (2011) Land Use Change in a Biofuels
Hotspot: The Case ofIowa, USA. Biomass and Bioenergy, 35(6),2391-2400.
Solomon BD, Barnes JR, and Halvorsen KE. (2007) Grain and Cellulosic Ethanol: History,
Economics, and Energy Policy. Biomass and Bioenergy, 31(6),416-425.


USDA-ERS (2009) Briefing Rooms. Corn: Trade. United States Department of Agriculture ­
Economic Research Service. Retrieved January, 2011 from
bttp://www.ers.lIsda.gov/Briefing/com/trade.htm


USDA-ERS (2011a) The Ethanol Decade: An Expansion of U.S. Com Production, 2000-09.
EIB-79. United States Department of Agriculture, Economic Research Service.


Retrieved September, 2011 from http://www.ers.usda.gov/Publications/EJB79/ErB79.pdf


USDA-ERS (2011 b) Usda Agricultural Projections to 2020. United States Department of
Agriculture -Economic Research Service. Retrieved March, 2011 from


http://www.ers.lIsda.gov/Publications/OCEIII/OCEl

J

I.pdf


USDA-FAS (2011) Conservation Programs. United States Department of Agriculture -Farm
Service Agency. Retrieved 2011, October from


http://www.l·sa ,usda,gov /FSA/webapp?area=home&su bject=copr&topic=crp-st
USDA-FSA (2011) Crp Enrollment and Rental Payments by State. United States Department of
Agriculture -Farm Service Agency. Retrieved October, 2011 from


http://ww,,v . fsa. usda .gov IFSA/webapp ?area=home&subject=copr&topic=rns-css
USDA-NASS (2011) Quickstats 1.0. United Stated Department of Agriculture -National
Agricultural Statistics Service. Retrieved October, 2011 from


http://www.nass.lIsda.gov/QuickStats/Create Federal AIl.jsp
USDA. (2009a).2007 Census of Agriculture: United States Summary and State Data. Last
accessed from
USDA (2009b) Summary Report: 2007 National Resources Inventory. Natural Resources
Conservation Service
Center for Survey Statistics and Methodology. Retrieved from


http://vvww.nrcs.usda,gov/technicaIINRII2007/2007 NRT Summary.pdf
Comment 12: Several commenters asserted that the MON87460 EA did not sufficiently
address the relationship between conservation tillage (thus facilitated by GE crops, like
MON87460 corn), carbon sequestration, and global climate change. Additionally, several
commenters also asserted that the MON87460 EA did not examine the influence of
conservation tillage strategies on emission of nitrous oxide, a potent greenhouse gas (GHG),
potentially offsetting any gains achieved through a potential increase in carbon
sequestration and reduced carbon dioxide emission.


Response 12: In regard to global climate change, APHIS recognizes and understands that
agricultural activities (including, but not limited to tillage and other management strategies)
contribute to the release of GHG emissions that may affect global climate change. However, the
EA was written in response to the Monsanto Company's petition for determination of


34
nonregulated status ofMON87460 corn and not to address the effects of agriculture or

genetically engineered crop production systems on global climate change. It is prudent to

mention, however, that management practices between MON87460 corn and currently available

corn varieties are unlikely to be dissimilar, considering the likelihood of stacking MON87460

corn with other corn events that have previously been determined to no longer be subject to the

regulatory requirements of7 CFR part 340 or the plant pest provisions ofthe Plant Protection

Act (as described in Chapter 4.1 0 ofthe EA) and the almost universal adoption ofgenetically

engineered corn production systems in the U.S. Chapter 2.2.4 of the EA was rewritten in

recognition ofthe relationship between agricultural activities such as conservation tillage, GHG

emissions, and global climate change. A conventional paradigm generalizing the relationship

between conservation tillage strategies and GHG emissions is dependent on a number of factors,

including geographic location, soil structure, moisture availability, and agronomic management

practices. Given the variability of these parameters, tillage impacts may be beneficial, neutral, or

detrimental.


Comment 13: Several commenters claimed that the EA failed to discuss the relationship

between increased pesticide application (associated with conservation tillage) and climate

change if MON87460 corn were granted a determination of nonregulated status.


Response 13: As stated in Chapter 4.10 of the EA and the MON87460 petition, MON87460 is

likely to be stacked with GE traits that have previously been determined to no longer be subject

to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant

Protection Act, such as readily available glyphosate tolerant and Bt traits, and very unlikely to be

grown as a standalone corn variety (Monsanto, 2010). As an example, a corn variety containing

MON87460 and glyphosate tolerance may be cultivated in place of a corn variety containing

only glyphosate tolerance. Also, as discussed in Chapters 2.1.1, 4.3.1.1, 4.3.1.2 of the EA,

MON87460 is unlikely to increase corn acreage beyond projected values. Thus, any increase in

pesticide usage beyond that associated with projected com acreage increases (USDA-ERS, 2011)

due to MON87460 is unlikely, because any variety containing MON87460 can be viewed as a

replacement product for com varieties that already require similar pesticide application strategies

and that expectation that MON87460 itself is unlikely to increase corn acreage.


In regard to climate change, APHIS recognizes and understands that agricultural activities

contribute to the release of GHG emissions that may act as affecters of global climate change.

However, the EA was written in response to the Monsanto Company's petition for determination

of non regulated status of MON87460 corn and not to address the specific effects of agriculture

or genetically engineered crop production systems on global climate change. APHIS directs

readers to Chapter 2.2.4 of the EA for a discussion of climate change and agriculture.


References

Monsanto (2010) Petition for the Determination ofNonregulated Status for Mon 87460.


Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://www.aphis.usda.govlbiotechnologv/notreg.html).


35

USDA-ERS (2011) Usda Agricultural Projections to 2020. United States Department of


Agriculture -Economic Research Service. Retrieved March, 2011 from


http://www.ers.usda.gov/Publications/OCEllllOCEll1.pdf


Comment 14: A commenter claimed that the MON87460 EA failed to examine the
displacement of less environmentally friendly crops, such as wheat, soybeans, and sorghum
by MON87460 corn.


Response 14: Farm-levelland-use decisions on U.S. farms are often dependent on both market
forces and government policies on the local, regional, and national level. It is unlikely that a
determination of nonregulated status of MON87460 com would significantly impact current and
future com production trends, as described in Chapter 4.3 of the EA. Historical data collected by
United States Department of Agriculture - National Agricultural Statics Service (USDA-NASS)
shows that planted com acreage has generally increased over time as a result of increased
production efficiency, improved hybrid com varieties, and a net increase in harvested acreage;
consequently, other crops such as sorghum, cotton, and wheat generally show decreases in
planted acreage over the same time frame (USDA-NASS, 20 II). This trend in increased com
acreage is readily apparent between 2000 and 2009, where an approximate 10 percent increase in
harvested com acreage coincided with domestic bioenergy policy and an increased demand for
ethanol and its com grain feedstock (USDA-ERS, 201Ia). In general, increased demand for com
grain has resulted in U.S. farmers generaJly shifting agricultural acreage away from other crops,
such as soybean and wheat, into com production for both the present and future outlooks
(USDA-ERS,2011b). An examination of aggregate (national, state, and county) and farm-level
data within this period (2006 - 2008, when acreage peaked) by United States Department of
Agriculture Economic Research Service (USDA-ERS) revealed that both com and soybean
acreage increased at the expense of other crops in both the short run (2006-2008) and the long
run (2000-2009) (USDA-ERS, 2011a). Additionally, further examination of farm-level data to
provide finer detail on how harvested com acreage may have expanded (i.e., conversion of
previously uncultivated or fallowed land to agricultural production) revealed that the observed


increase in com production resulted primarily at the expense of cultivated crop acreage (e.g.,
soybean, cotton, wheat) and with a smaller proportion coming from uncultivated/fallowed land
(30 percent) (USDA-ERS, 2011a). The primary source of this uncultivated land/fallowed land,
however, was hay and grazing land, as only two percent of corn and soybean farms brought
Conservation Reserve Program (CRP) land into production in 2007, following the peak in
domestic com acreage (USDA-ERS, 201

I

a).


Thus, the current trend of increasing com acreage primarily at the expense of other crop acreage


has been occurring independent of any regulatory decision on MON87460 com. Consequently,
current and future market forces affecting com price and a variety of government policies are


likely to continue affecting farm-levelland-use decisions. A determination of nonregulated


status of MON87460 com is unlikely to disrupt this trend, due to the relatively smal1 proportion
of domestic corn production it is likely to represent and the incidence ofcurrent com production
trends already occurring without the commercialization of MON87460.


36
References

USDA-ERS (201Ia) The Ethanol Decade: An Expansion of U.S. Corn Production, 2000-09.


EIB-79. United States Department of Agriculture, Economic Research Service.


Retrieved September, 2011 from http://www.ers.lIsda.gov/Publicatiol1s/E1B79/E1B79.pdf


USDA-ERS (201Ib) Usda Agricultural Projections to 2020. United States Department of
Agriculture - Economic Research Service. Retrieved March, 20 II from


http://www.ers.usda.gov/Publications/OCEIII/OCEJ II.pdf
USDA-NASS. (20 11) Corn, Cotton, Sorghum, Soybean, and Wheat Planted Acreage (1985 ­
2010). Retrieved September, 20 II from United States Department of Agriculture,


National Agricultural Statistics Service


http://www.nass.usda.QJw/QuickStats/Create Federal AIJ.jsp


Comment 15: Several commenters asserted that GE crops, like MON87460 corn, increases
the frequency of animal and human diseases/pathogens, and cited the letter to Agriculture
Secretary Vilsack from retired Professor Don Huber as support for this contention.
Response 15: Professor Huber's letter alleges that either the gene to produce glyphosate tolerant
crops or the use of glyphosate (Roundup) is either a promoter or cofactor that facilitates a
pathogen capable of infecting soybean, corn, their products, various livestock and "probably
human beings." The letter claims evidence for the pathogen in electron micrographs (which are
not published) and alleges animal infertility (anecdotes, none published, with no general
corroboration), and a claim for escalating frequency of Goss' wilt in corn, and sudden death
syndrome in soybean (no data to support the claims). Where animal abortions were noted, an
inference was made that animals consumed a wheat product, on which glyphosate may have
been used indirectly. While these hypotheses are certainly remarkable, there has been no
evidence provided for most of these statements. Until Prof. Huber publishes his methods, results
and conclusions, scientists have no basis for evaluating these claims.


Comment 16: Several commenters expressed concern that both NPTII and CSPB (the two
introduced proteins in MON87460) are not sufficiently examined in the MON87460 EA,
citing a lack of objective or peer-reviewed evidence with regard to NPTII and CSPB.


Response 16: NPTII, which serves as a selectable marker in MON87460 corn, is a well
characterized and equally well established protein product in plant biotechnology. The toxicity
ofNPTII has been evaluated in both the peer-reviewed literature (Flavell et aI., 1992; Fuchs et
aI., 1993a; Fuchs et aI., 1993b; Nap et aI., 1992) and by government in different countries
(EFSA, 2007; FDA, 1998; OGRT, 2009). CSPB, originally derived from Bacillus subtilis, is
responsible for the MON87460 corn reduced yield loss phenotype under water-limited
conditions. CSPB does not possess any homology to any known toxin or allergen (Burzio et at,
2008) and is well studied in the peer-reviewed literature (Graumann and Marahiel, 1994;
Graumann et aI., 1996; Willimsky et aI., 1992). As described in Chapter 4.5.1.2 and Chapter 4.6
of the the donor organism of CSPB, B. subtilis, is not pathogenic and is frequently found in
fermented foods that have been consumed by humans frequently and for a long time.
Additionally, the peer-reviewed literature demonstrates that enzyme preparations from B. subtilis


37
are not toxic to animals and thus would not be expected to be toxic to humans (Hong et ai.,

2008~



Simon M, 2011). A search ofthe published literature by Food Safety Australia New Zealand

(FSANZ) did not identify any journal articles relating to the allergenicity of any ofthe bacterial

cold shock proteins (FSANZ, 2010). Additionally, government regulators from both the U.S.

Food and Drug Administration (FDA) and FSANZ have determined that B. subtilis does not pose

any specific risk to human health, with the FDA designating enzyme preparations from B.

subtilis as generally recognized as safe (GRAS) (FDA, 1999,2010; FSANZ, 2010).

Furthermore, FSANZ has already determined that MON87460 com does not pose any public

health or safety issues, and considers MON87460 com as safe and wholesome as food derived

from other commercial corn varieties (FSANZ, 2010).


References
Burzio LA, McClain JS, and Silvanovich A. (2008). Bioinformatics Evaluation ofthe Cspb
Protein Utilizing the Ad8, Toxin6 and Protein Databases. Monsanto Company.
EFSA (2007) Efsa Review of Statistical Analyses Conducted for the Assessment ofthe Mon863
90-Day Rat Feeding Study. European Food Safety Authority.


FDA (1998) Guidance for Industry: Use ofAntibiotic Resistance Marker Genes in Transgenic
Plants. U.S. Food and Drug Administration. Retrieved September, 2011 from


http://www.fda.gov/food/guidancecompliancercgulatoryinfonnation/guidancedocuments!
Qiotechnolouy/ucm096 I 35.htm
Carbohydrase and Protease Enzyme Preparations Derived from Bacillus Subtilis or Bacillus
Amyloliquefaciens; Affirmation of Gras Status as Direct Food Ingredients, FDA.


FDA (2010) List of Completed Consultations on Bioengineered Foods. United States Food and
Drug Administration, Center for Food Safety and Applied Nutrition, College Park,
Maryland. United States Food and Drug Administration. Retrieved January 2011 from


http://www.fda.gov/Food/Biotechnologv/Submissions/default.htm
Flavell RB, Dart E, Fuchs RL, and Fraley RT. (1992) Selectable Marker Genes: Safe for Plants?


Biotechnology(lO), 141-144.


FSANZ (2010) Supporting Document 1: Application A1029 Food Derived from Drought­
Tolerant Com Line Mon87460 Approval Report. Food Standards Australia New Zealand.


Fuchs R, Heeren R, Gustafson M, Rogan G, Bartnicki D, Leimgruber R, Finn R, Hershman A,
and Berberich S. (1993a) Purification and Characterization of Microbially Expressed
Neomycin Phosphotransferase Ii (Nptii) Protein and Its Equivalence to the Plant
Expressed Protein. Nature Biotechnology, 11(12), 1537-1542.


Fuchs RL, Ream JE, Hammond BG, Naylor MW, Leimgruber RM, and Berberich SA. (1993b)
Safety Assessment ofthe Neomycin Phosphotransferase Ii (Nptii) Protein. Nature
Biotechnology, 11(12), 1543-1547.


Graumann P and Marahiel MA. (1994) The Major Cold Shock Protein of Bacillus Subtilis Cspb
Binds with High Affinity to the Attgg- and Ccaat Sequences in Single Stranded
Oligonucleotides. FEBS Letters, 338(2), 157-160.


Graumann P, Schroder K, Schmid R, and Marahiel M. (1996) Cold Shock Stress-Induced
Proteins in Bacillus Subtilis. J Bacteriol., 178(15),4611-4619.


Hong HA, Huang JM, Khaneja R, Hiep LV, Urdaci MC, and Cutting SM. (2008) The Safety of
Bacillus Subtilis and Bacillus Indicus as Food Probiotics. Journal ofApplied
Microbiology, 105(2), 510-520.


38
Nap J-P, Bijvoet J, and Stiekema W. (1992) Biosafety of Kanamycin-Resistant Transgenic


Plants. Transgenic Research, 1(6),239-249.
OGRT (2009) Risk Assessment and Risk Management Plan for Dir 95 - Limited and Controlled
Release of Sugar Cane Genetically Modified for Altered Plant Growth, Enhanced
Drought Tolerance, Enhanced Nitrogen Use Efficiency, Altered Sucrose Accumulation,
and Improved Cellulosic Ethanol Production From. Australian Government, Department
of Health and Ageing, Office of the Gene Technology Regulator.


Simon M C. (2011) Bacillus Probiotics. Food Microbiology, 28(2), 214-220.

Willimsky G,Bang H, Fischer G, and Marahiel MA. (1992) Characterization of Cspb, a Bacillus


Subtilis Inducible Cold Shock Gene Affecting Cell Viability at Low Temperatures. J.


Bacteriol., 174(20),6326-6335.


Comment 17: Several commenters expressed concern regarding horizontal and vertical
gene transfer from MON87460 corn, noting specifically that: a) Genetic material inserted
into GE soy transfers into the DNA of bacteria living inside human intestines; b) Gene
transfer between MON87460 and other plants may lead to the generation of herbicide
resistant weeds; and c) That gene flow between corn and teosinte may reduce the genetic
diversity of teosinte, creating problems for farmers that use teosinte for breeding improved
corn.


Responses 17: As mentioned in Chapter 4.7.2 of the EA, the Food and Drug Administration
(FDA) has previously concluded that the likelihood of horizontal gene transfer from plant
genomes to microorganisms in the gastrointestinal tract of humans, animals, or the environment
is remote (FDA, 1998). In regard to the claim that genetic material transfers from human­
consumed GE soy into the DNA of human gastrointestinal tract bacteria, this appears to be a
misrepresentation of the results from the peer-reviewed journal article entitled "Assessing the
survival of transgenic plant DNA in the human gastrointestinal tract" by Netherwood et al. In
the original publication, low-frequency gene transfer from GE soy to the microflora of the small
bowel occurred in three out of seven human ileostomists (Netherwood et aI., 2004). Ileostomists,
however, represent an artificial system where the end of the small intestine is separated from the
large intestine and connected to collection receptacle; thus, ingested material does not normally
proceed through the complete human digestive system, where it normally remain in the large
intestine for approximately 16 hours. Furthermore, when the experiment was repeated in the
absence ofileostomists (Le., complete gastrointestinal passage that is more representative of true
human digestive physiology), the authors concluded that the transgene contained within the GE
soy did not survive passage through human subjects with intact gastrointestinal tracts and that
horizontal gene transfer did not occur during this feeding experiment (Netherwood et aI., 2004).


Additionally, it is unlikely that vertical gene transfer (Le., gene flow) from MON87460 to
sexually compatible relatives will lead to the production of herbicide resistant weeds or a
reduction in the genetic diversity of teosinte, the wild progenitor of domesticated corn. As
discussed in Chapter 4.5.4 ofthe EA, MON87460 does not differ from currently available corn
varieties with regard to pollen or seed attributes; thus, MON87460 is not any more likely to
hybridize with sexually compatible relatives than any currently available corn variety. Sexually
39

compatible relatives in the u.s. include Tripsacum dactyloides, Tripsacumfloridanum, and
teosinte. As discussed in Chapter 4.5.2 ofthe EA, due to the absence ofreproductive differences
between MON87460 and commercially-available corn, MON87460 is unlikely to successfully
hybridize with Tripsacum dactyloides and Tripsacumfloridanum under normal field conditions
due to various sterility mechanisms, chromosomal mismatch, and significantly reduced offspring
fitness (Mangelsdorf, 1974). Consequently, although MON87460 may be stacked with herbicide
tolerant traits events that have previously been determined to no longer be subject to the
regulatory requirements of7 CFR part 340 or the plant pest provisions ofthe Plant Protection
Act, it is unlikely that gene flow will between corn and sexually compatible relatives will lead to
the formation of herbicide resistant weeds. Also, as discussed in Chapter 4.5.2 and Chapter 4.5.4
of the EA, MON87460 is unlikely to successfully hybridize with teosinte (e.g., Zea Mexicana
and Z. perennis) in the U.s. due to the limited distribution ofteosinte, and differences in
flowering time and reproductive compatibiity (Galinat, 1988). Thus, due to unlikely nature of
introgression of genetic material from MON87460 to teosinte, it is also unlikely that MON87460
will erode the genetic diversity ofteosinte in the U.s.


References

FDA (1998) Guidance for Industry: Use ofAntibiotic Resistance Marker Genes in Transgenic


Plants. U.S. Food and Drug Administration. Retrieved September, 2011 from


http://www.fda.gov ffood/ guidancecom pI ianceregulatorv i nformation/ gu idancedocuments/


biotechnologv/ucm096135.htm
Galinat W. (1988) The Origin of Corn. In GF Sprague and JW Dudley (Eds.), Corn and Corn
Improvement (pp. 1-27). Madison, WI: American Society ofAgronomy, Inc., Crop Soil
Science Society of America, Inc., and the Soil Science Society ofAmerica, Inc.
MangelsdorfPC. (1974) Corn: Its Origin, Evolution, and Improvement. Harvard University


Press Cambridge, MA.
Netherwood T, Martin-Ortie S, O'Donnell A, Gockling S, Graham J, Mathers J, and Gilbert H.
(2004) Assessing the Survival of Transgenic Plant DNA in the Human Gastrointestinal
Tract. Nature Biotechnology, 22(2),204-209.


Comment 18: Several commenters asserted that genetically engineered (GE) commodities


and respective agricultural practices have been proven to have adverse effects on human


and livestock health, including generalized statements suggesting that GE plants are


associated with increased organ failure, inflammatory bowel disease, reduced


fecundity/fertility, asthma, lung damage, digestive problems, celiac's disease, obesity,


Morgellon's Disease, autoimmune disorders, autism, and increased endocrine system


damage. One commenter suggested that the increased prevalence of GE crops is


responsible for the increase of many serious diseases in the U.S. Furthermore, one


comment alluded to studies by Dr. Irina Ermakova and a separate study from the Baylor


college of medicine as evidence that GE crops were detrimental to human health;


additionally, another commenter cited a study undertaken by Vendomois et al (2009) in


hamsters and rats (2009) as evidence that GE plants contribute to birth defects, high


informant mortality rates, and sterility in humans.


40

Response 18:

As described

in

Chapter 1.1 and Chapter 1.6 ofthe EA, the U.S. Food and Drug
Administration (FDA) is responsible for ensuring the safety of all food and feed derived from
GE plants. No U.S. agency has made an assertion linking GE crops to the presence or increased
prevalence of any disease. Furthermore, following a report from the European Commission
(2011) examining the risk of GE crops, it was stated that "The main conclusion to be drawn from
the efforts of more than 130 research projects, covering a period of more than 25 years of
research, and involving more than 500 independent research groups, is that biotechnology, and in
particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies".


Following a consultation between FDA and the Monsanto Company, FDA determined that
MON87460 com is not materially different from currently-available com varieties, thus
concluding that MON87460 does not pose any increased risk with regard to food and feed safety
relative to currently-available com varieties (FDA, 2010). Additionally, description of in silico
analysis of the two inserted, fully functional, genetic elements (NPTn and CSPB) in Chapter


4.6.1.2

ofthe EA state that neither NPTII nor CSPB share any amino acid sequence similarities
with known allergens, gliadins, gluten ins, or protein toxins which have adverse effects on
mammals. NPTII is the most common selectable marker utilized in GE plants, and has been
utilized in 28 petitions that have previously been determined to no longer be subject to the
regulatory requirements of7 CFR part 340 or the plant pest provisions of the Plant Protection
Act; additionally, the general safety ofNPTII has been described by both the EPA (through the
granting of an exemption oftolerance) and the European Food Safety Authority (EFSA). Also as
described in Chapter 4.6.1.2 ofthe EA, CSPB has been shown to: I) be rapidly digested in
simulated gastrointestinal fluid, a characteristic shared among many proteins with a history of
safe consumption; 2) share 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; and 3) be one component of an enzyme preparation that is generally recognized as safe
(GRAS) by the FDA from Bacillus subtilis, the ubiquitous microorganism from which CSPB is
derived and is found in many fermented foods that are frequently consumed by humans.
Compositional analysis ofMON87460 com described by the Monsanto Company Petition
(Monsanto, 20 I0) demonstrated that neither NPTII or CSBP expression or activity results in any
meaningful differences for grain and forage compositions either for major nutrients or secondary
metabolites. Collectively, these data strongly suggest that the no meaningful changes, aside from
the reduced yield loss phenotype under water-limited conditions, are derived from the
transformation event itself.
MON87460 com does not contain any plant incorporated protectants (PIPs) that may confer an
insect resistance phenotype or herbicide resistance traits. However, as examined in the EA, it is
foreseeable that MON87460 may be conventionally crossed with com varieties containing GE
traits that have previously been determined to no longer be subject to the regulatory requirements
of 7 CFR part 340 or the plant pest provisions ofthe Plant Protection Act. Thus, progeny of
MON 87460 com may potentially contain a stack of traits, including drought tolerance, insect
resistance, or herbicide tolerance. It is important to note that any trait foreseeably stacked with
MON87460 that have previously been determined to no longer be subject to the regulatory
requirements of 7 CFR part 340 or the plant pest provisions ofthe Plant Protection Act, will


41

represent a trait that has been previously shown to neither pose a plant pest risk nor present a
significant impact on the human health.


The majority of health effects claims were not substantiated without any references from the
peer-reviewed literature. Thus, APHIS finds it difficult to address these claims directly; in lieu
of provided references, APHIS directs commenters to the sections of the EA mentioned above
and the preceding paragraphs discussing the health and safety of MON87460 corn and its
introduced proteins. In regard to study by Irina Ermakova on GE soy and rat health, it is prudent
to mention that the data from this study was neither peer-reviewed nor published in the peer­
reviewed literature (Marshall, 2007); consequently, APHIS cannot address these claims directly.
Following an moderated interview feature in Nature Biotechnology, however, several experts
discovered flaws in the experimental design of Ermakova' s study that make it very difficult to
conclude any relationship between GE soy and rat health (Chassy et aI., 2007). Additionally, in
the study alluded to by the Baylor College of Medicine, the commenters' claim is without much
warrant, as the original authors of the paper make no mention of GE com in the journal article
(Markaverich et aI., 2001).


In the referenced study ofVendomois et al (2009), it was concluded that several sex-and dose­
dependent effects (e.g., organ weights and blood chemistry) observed in rats were linked with
GE corn consumption. Several independent scientific groups and regulatory agencies have
reviewed and refuted this study, including the French High Council on Biotechnology (HCB),
Food Standards Australia New Zealand (FSANZ), and the European Food Safety Authority
(EFSA) S(EFSA, 2007; FSANZ, 2009; HCB, 2009). The three scientific groups or regulatory
agencies agreed that the conclusions presented by Vendomois et at. (2009) rely primarily on
statistical analysis and fail to interpret these differences within a biological or toxicological
context. Nonnal background variability between animals fed with different diets was ignored.
Additionally, HCB, FSANZ, and the EFSA concluded, based on the data published in


Vendomois et aL (2009), that no new evidence was provided about the general safety of these
GE plants, and that there was no reason to reconsider the safety assessments previously
completed forNK603, MON8IO, and MON863 com (EFSA, 2010; FSANZ, 2009; HCB, 2010;
Monsanto, 2010).


References


Chassy B, Moses V, McHughen A, and Giddings V. (2007) Response to Gm Soybeans­
Revisiting a Controversial Format. Nature Biotechnology, 25(12), 1356-1358.
EFSA (2007) Efsa Review of Statistical Analyses Conducted for the Assessment of the Mon863
90-Day Rat Feeding Study. European Food Safety Authority.
FDA (2010) List of Completed Consultations on Bioengineered Foods. United States Food and
Drug Administration, Center for Food Safety and Applied Nutrition, College Park,


Maryland. United States Food and Drug Administration. Retrieved January 2011 from


http://www.fda.gov/Food/Biotechnology/Submissions/default.htm


FSANZ (2009) Fsanz Response to a Comparison of the Effects of Three Gm Corn Varieties on
Mammalian Health. Food Standards Australia and New Zealand. Retrieved September,
2011 from


42

http://

www.foodstandards.gov.au/sc ienceanded ucat ion/factsheets/facts heets2 009 Ifsanzre s
ponsetoseraI4647.cfm.
HCB (2009) Opinion Relating to the Deposition of 15 December 2009 by the Member of
Parliment, Froncois Grosdidier, as to the Conclusions of the Study Entitled "a
Comparison of the Effects of Three Gm Com Varieties on Mammalian Health" by 1.
Spiroux De Vendomois, F. Roullier, D. Cellier, and G.E. Seralini, Int. J. BioI. Sci: 5(7):
706-726. High Council of Biotechnologies.


Markaverich B, Mani S, Alejandro M, Mitchell A, Markaverich D, Brown T, Velez-Trippe C,
Murchison C, O'Malley B, and Faith R. (2001) A Novel Endocrine-Disrupting Agent in
Com with Mitogenic Activity in Human Breast and Prostatic Cancer Cells.
Environmental Health Perspectives, 110(2), 169-177.


Marshall A. (2007) Gm Soybeans and Health Safety - a Controversy Reexamined. Nat Biotech,
25(9),981-987.


Monsanto (2010) Petition for the Detennination ofNonregulated Status for Mon 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://\yww.aphis.usda.gov/biotechnologv/l1otreg.html).
UC (2011) A Decade of Eu-Funded Gmo Research. Brussels, Belgium: European Commission­
Directorate General for Research and Innovation Biotechnologies, Agriculture, Food.


Comment 19: Several commenters expressed concern regarding a study by Aris and
Leblanc (2011) describing the detection ofthe Cry1ab protein in maternal blood serum
(non-pregnant and pregnant women) and fetal blood serum (human fetuses). Several
commenters also raised concern with regard to a study by Benachour and Seralini (2009)
entitled "Glyphosate formulations induce apoptosis and necrosis in human umbilical,
embryonic, and placental cells." Additionally, several commenters generally stated that
more long-term human studies were needed for GE crops, including MON87460.


Responses 19: In the study by Aris and Leblanc (2011), the Crylab protein (a common
insecticidal protein introduced into GE crops, such as com) was detected in 93 percent of
maternal blood, 80 percent of fetal blood, and 69 percent of blood from non-pregnant women.
The subjects ofthis study all resided in Sherbrooke, an urban area of Eastern Townships of
Quebec, Canada. MON87460 does not contain any Bt traits; however, these traits may be
introduced through conventional breeding, as described in Chapter 5 of the EA.


While Aris and Leblanc (2011) detected the Crylab protein in the majority ofblood samples
tested, the authors did not make any effort to detennine the origin ofthe Crylab protein, only
assuming that the source of Cry 1 ab must be through the consumption of GE crops, "given the
widespread use ofGM [GE] foods in the local daily diet (soybeans, com, potatoes ...), it is
conceivable that the majority of the population is exposed through their daily diet." However,
the authors neglect to mention that Bacillus thuringiensis, a bacterium from which Crylab is
derived and produced, is commonly used in organic fanning (either as proteins sprays or sprays
ofthe B. thuringiensis itself) (Aroian, 2011; EPA, 2005). In previous studies, naturalIy­
occurring B. thuringiensis has been detected in fresh fruits and vegetables (Frederiksen et aI.,


43

2006); milk, ice cream, and green-tea samples (Zbou et aI., 2008); and human nasal samples
following aerial sprays to control gypsy moth populations (Valadares de Amorim et ai., 2001).


Additionally, Aris and Leblanc (2011) made no effort to eliminate the possibility of detecting
false positives through the ELISA-based screening kit (DAS ELISA kit for Bt-Crylab/lAc
protein, Agdia). Tbe detection limit for the DAS ELISA kit for Bt-CrylabllAc protein is
reported to be 1 ng/ml (Paul et aI., 2008); however, Aris and Leblanc detected the Crylab protein
at averaged levels of approximately 0.18

ng/ml
in the blood serum of pregnant women, 0.12
nglml in the blood serum of non-pregnant women, and 0.05
ng/ml
in the blood serum of human
fetuses. Tbe 1 ng/ml detection limit of tbe ELISA kit and the levels detected in the study is
problematic, as the detection limit ofa kit is generally regarded as the lowest possible for which
a user may reliably detect a compound. Unfortunately, no additional Crylab protein detection
method was cited in the Aris and Leblanc (20 11) study to corroborate and verify that these very
low detection levels did not consist of false positives, as would be standard practice. With regard
to the ELISA kit itself, it was not validated for its suitability to measure Crylab in human blood;
rather, it was designed to detect Cry I ab from plant tissues (Agdia, 2011; FSANZ, 2011).


APHIS also disagrees with the implication that Bt proteins (Cry family proteins) are inherently
dangerous to human health. APHIS directs commenters to previous EAs (USDA-APHIS, 2011)
that have examined the risk of human exposure to Bt proteins and determined that Bt proteins
pose little risk to human health.


With regard to Benachour and Seralini (2009), the entire study was conducted in vitro, meaning
that the study was conducted in an artificial environment outside of a living organism. Such
studies are useful for screening and prioritization purposes (e.g., designing in vivo studies), but
they have the major limitation of requiring extrapolation of the in vitro result to an in vivo
situation to reach the commenters' conclusion, especially in cases such has glyphosate where in
vivo tests have already been conducted and have demonstrated relatively low levels of overall
toxicity. In in vivo studies, the chemical form and dose can cbange in the intestine during
digestion, uptake, metabolism, and excretion, and be mediated by adsorbed proteins,
detoxification processes, and various immune and other protective responses, all of which affect
the dose and form of the chemical that ultimately comes in contact with the cell. An affected cell
in turn is then subject to possible repair and other protective mechanisms before the potential for
adverse health effects is realized. Also, aside from in vitro glyphosate application, this study
also used glyphosate formulations, which include surfactants and other ingredients. These raise
the question about what chemical is actually being studied and causing the effects. Furthermore,
applying these formulations directly to cell lines is a very different situation for the cells in terms
ofthe types and concentrations of chemicals compared to what the cells would be exposed to
after oral, inhalation, or dermal uptake, metabolism, etc.


In summary, APHIS believes that tbe study of Ads and Leblanc (2011) possesses several short­
comings that bring its conclusions about the detection of the Crylab protein into doubt. These
include issues surrounding the source ofthe Cry lab detected, problems with the assay method
used to detect the Crylab protein, and the implication that Cry lab poses any significant risk to


human health. Additionally, APHIS also believes tbat the limitations of in vitro glyphosate
44

toxicity studies cannot be overlooked, and that it should be taken in context of in vivo studies that
have already been performed that suggests a relatively low overall toxicity of the compound
(Williams et aI., 2000).


With regard to commenter claims that more long-term studies are required for MON87460 com,


APHIS concluded that there were no short-term impacts from MON87460 and its engineered


proteins (e.g., NPTn and CSPB) on human and animal health (Chapters 2.3.1; 2.4; and 2.5 of the


EA). Because no short-term impacts were not noted, there is no reason to continue looking for
long-term impacts.


References
Agdia (2011) Das Elisa for the Detection of Bt-Crylab/Iac Proteins. Agdia. Retrieved October,


2011 from https://orders.agdia.com/Documents/mI72.pdf


Aris A and Leblanc S. (2011) Maternal and Fetal Exposure to Pesticides Associated to
Genetically Modified Foods in Eastern Townships of Quebec, Canada. Reproductive
Toxicology, 31(4),528-533.


Aroian R (20 II) Bacillus Thuringiensis -Organic Farming. University of California San Diego.
Retrieved October, 20 II

from http://www.bt.ucsd.edlj/organic farming.html
Benachour Nand Seralini G. (2009) Glyphosate Formulations Induce Apoptosis and Necrosis in
Human Umbilical, Embryonic, and Placental Cells. Chemical Research in Toxicology,
22(1),97-105.


EPA (2005) Bacillus Thuringiensis Cry3bbl Protein and the Genetic Material Necessary for Its
Production (Vector Zmir13l) in Event Mon 863 Com & Bacillus Thuringiensis Crylab
Delta Endotoxin and the Genetic Material Necessary for Its Production in Com (006430,
006484) Fact Sheet Enviromental Protection Agency. Retrieved October, 2011 from


http://wlA'W.epa.gov/pesticides/biopesticides/ingredients/factsheets/factsheet 006430­


006484.htm


Frederiksen K, Rosenquist H, Jorgensen K, and Wilcks A. (2006) Occurrence of Natural Bacillus
Thuringiensis Contaminants and Residues of Bacillus Thuringiensis-Based Insecticides
on Fresh Fruits and Vegetables. Appl. Environ. Microbiol., 72(5),3435-3440.


FSANZ (201l) Fsanz Response to Study Linking Crylab Protein in Blood to Gm Foods. Food
Standards Australia and New Zealand. Retrieved October, 2011 from


http://www.foodstandards.gov.au/consumerinformation/gmfoods/fsanzresponsetostudv51


85.cfm


Paul V, Steinke K, and Meyer HHD. (2008) Development and Validation ofa Sensitive Enzyme
Immunoassay for Surveillance of Crylab Toxin in Bovine Blood Plasma of Cows Fed
Bt-Maize (Mon81 0). Analytica Chimica Acta, 607(1), 106-113.


USDA-APHIS (2011) Petitions for Nonregulated Status Granted or Pending by Aphis. United
States Department of Agriculture -Animal and Plant Health Inspection Service.


Retrieved September, 2011 from http://www.aphis.usda.govlbiotechnologv/notreg.htm!


Valadares de Amorim G, Whittome B, Shore B, and Levin DB. (2001) Identification ofBacillus
Thuringiensis Subsp. Kurstaki Strain Hdl-Like Bacteria from Environmental and Human
Samples after Aerial Spraying of Victoria, British Columbia, Canada, with Foray 48b.
Appl. Environ. Microbiol .. 67(3), 1035-1043.


45

Williams GM, Kroes R, and Munro IC. (2000) Safety Evaluation and Risk Assessment ofthe


Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans. Regulatory


Toxicology and Pharmacology. 31(2), 117-165.
Zhou G, Yan J, Dasheng Z, Zhou X, and Yuan Z. (2008) The Residual Occurrences of Bacillus


Thuringiensis Biopesticides in Food and Beverages. International Journal ofFood


Microbiology, 127(1-2), 68-72.


Comment 20: Several comments suggested that APHIS failed to adequately analyze the
impact of a determination of nonregulated status of MON87460 on the public's right to
choose non·GE foods, citing a 2010 National Public Radio (NPR) poll indicating that "an
overwhelming number of Americans are wary of GE crop production in the U.S."
Additionally, several comments endorsed the labeling of GE foods or foods containing GE
ingredients, citing a "recent opinion poll that up to 90 percent of Americans support the
labeling of GE ingredients" and a poll released by ABC news.


Response 20: APHIS acknowledges that the public has a right to choose non-GE foods
(Anderson, 2008). Recent comments by Secretary Vilsack demonstrate USDA's goal to "ensure
that all forms of agriculture thrive so that food can remain abundant, affordable, and safe" and
thereby promoting an individual's choice to purchase or grow food produced by either
conventional, GE, or organic methods. To fulfill its commitment to NEPA, APHIS has
conducted an environmental assessment analyzing the potential impacts of MON87460 com on
all forms of agriculture. Based on the analysis provided in Chapter 4.3,4.5 and 4.8 ofthe EA,
APHIS concluded that there is no evidence for significant environmental impact on conventional
or organic agriculture.


However, APHIS disagrees with the conclusion that an overwhelming number of Americans are
wary ofGE crop production in the U.S., based on the cited and misrepresented 2010 NPR poll.
Firstly, while the word "wary" is used in reference to GE salmon in the NPR article describing
this poll, "wary" is not used anywhere in the survey questions regarding genetically engineered
foods (Hensley, 2010; NPR, 2010). Secondly, only 15 percent ofthe 3,025 people surveyed
believed that GE foods were not safe; an additional 64 percent was unsure about the safety of GE
foods, while 21 percent believed the GE foods were safe (NPR, 2010). Thirdly, a majority
(60%) ofthose polled indicated that they were willing to eat GE vegetables, fruits, and grains,
thus dispelling any notion that an overwhelming proportion of the popUlation is wary about U.S.
GE crop production (NPR, 2010). What this po]] did show, however, was that 93 percent of
those polled believed that foods should be labeled to indicate that they have been genetically
engineered or contain genetically engineered ingredients (Hensley, 2010; NPR, 2010).
Additionally, a poll conducted by ABC news also supports this number (ABC News, 2003).
While these poB numbers supports another cited poll that states "recent opinion polls indicate
that up to 90 percent of Americans support labeling ofGE ingredients," this does not indicate
that labeling is entirely related to a desire to avoid GE foods. Examining the study in further
detail, the conclusion drawn by the writers of the report state that: "Though it appears that most
Americans want GM foods labeled, it is possible that their stated preference for such a label
could stem from a more general desire for more information about the foods they eat." In order


46

to test this, the developers asked the participants to rate how important it was that food labels


indicate certain information (Hallman et aI., 2004). The conclusions from that test indicated that

the information rated as most important to put on a label was "whether pesticides were used in

the process of growing the food." Next in importance was information concerning "whether the

food contains GE ingredients" and "ifthe food was grown or raised organically," which were

rated as equally important. These results imply that consumers want a variety of additional

information on food labels and as concluded by the writers, "the support of such labels may be

more an issue of 'consumer sovereignty' rather than simple avoidance" (Hallman et aI., 2004).


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

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

do not pose a plant pest risk to the environment. The PP A does not grant APHIS authority to

label foods. As described in the EA, the Coordinated Framework for the Regulation of

Biotechnology indicates that three Federal agencies, APHIS, FDA and EPA, are responsible for

regulating biotechnology in the US. FDA regulates GE organisms under the authority of the

Federal Food, Drug, and Cosmetic Act. 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 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.


References

ABC News (2003) Modified Foods Gives Consumers Pause. ABC News. Retrieved October,


2011 from http://abcnews.go.com/images/pdf/930al FoodSafety.pdf


Anderson G. (2008) Lake County Votes to Ban Gmo Crops. The Press Democrat.
Hallman W, Hebden W, Cuite C, Aquino H, and Lang J (2004) Americans and Gm Food:


Knowledge, Opinion, and Interest in 2004. RR-1104-007. New Brunswick, New Jersey:


Food Policy Institute. Retrieved September, 2011 from


http://www.foodprocessing.comlM ediaJMediaManager/RutgersGMF oodStudv .

pdf
Hensley S (2010) Americans Are Way of Genetically Engineered Foods. National Public Radio.
Retrieved September, 2011 from


http://\vww.npr.org/blogs/health/20 11106/071131270519/americans-are-warv-about­
genetically-engineered-foods
NPR (2010) National Survey of Healthcare Consumers: Genetically Engineered Foods. Thomson
Reuters. Retrieved September, 2011 from


http://www.factsforhealthcare.com/pressroom/NPR report GeneticEngineeredFood.pdf
Comment 21: Several commenters expressed concern that pollen-mediated gene flow, the
lack of a proposed isolation distance by APHIS, and the possibility of seed mixture between
MON87460 (or genetically engineered [GE1 corn in general) and organic corn would result
in the adventitious presence of GE material in organic corn. These comments referenced
Star Link corn and Liberty Link Rice as evidence to support their claims that mixing of
GE and organic seed is inevitable. Consequently, several commenters suggested that the


47

EA failed to examine how the adventitious presence of MON87460 corn (or any other
variety ofGE corn) may impact the U.S. organic market.


Response
21:
In the U.S., only products produced using specitic methods and certified under
the USDA's Agricultural
~arketing
Service (AMS) National Organic Program (NOP) definition
oforganic farming can be marketed and labeled as "organic" (USDA-AMS-NOP, 2011).
Organic certification is a process-based certification, not a certification of the end product; the
certification process specifies and audits the methods and procedures by which the product is
produced. Consequently, USDA-certified organic labeling requires that growers develop and
submit an organic production plan in order to outline the steps taken to avoid contact or mixing
with the products of excluded methods (e.g., non-approved synthetic pesticides or fertilizers). In
accordance with NOP regulations, organic operators are required to manage the potential
exposure of organic commodities with other substances not approved for use in organic
production systems, whether from the non-organic portion of a split operation or from
neighboring farms. The use of GE products is specifically prohibited in organic production and
handling; however, the inadvertent presence of GE material in organic products is not sufficient
to preclude USDA-certified organic labeling ifthe organic producer followed hislher submitted
organic production plan (USDA-AMS, 2011). Implementation of procedures to maintain seed
and commodity integrity within the context ofan individual organic system plan required for
NOP certification has proven effective in preventing the presence ofexcluded materials in
certified organic products.


Growers have, for decades, been successfully growing crops bearing different traits and often on
adjoining fields despite the method by which traits were introduced (conventional breeding or
recombinant DNA technology). Growers have always had the choice of what crops to grow, and
have had to contend with commingling, admixtures, and other contaminants in their crops
(Ronald and Fouche, 2006). Studies of coexistence of major GE and non-GE crops in North
America and the European Union (EU) have demonstrated that there has been no significant
introgression of GE genes, and that GE and non-GE crops are coexisting with minimal economic
effects (Brookes and Barfoot, 2004a; Brookes and Barfoot, 2004b; Gealy et aI., 2007).
Ultimately, under NOP regulations, organic producers are obligated to manage their operations
to avoid unintentional contact with excluded methods. As described in Chapter 2.1.2.2 and
Chapter 4.3.3 of the EA, isolation distances, reproductive isolation (e.g., staggering planting
dates or growing corn with differential maturity times), and farmer communication can be
successfully used to minimize the effects of pollen-mediated gene flow from MON87460 corn
into organic corn. Growers can obtain the Association of Official Seed Certifying Agencies'
(AOSCA) reference material which describes the isolation distance requirements for the
certification ofcorn seed (AOSCA, 2003, 2009). Additionally, organic growers may also choose
to plant border rows to mitigate the movement of pollen derived from GE corn and use seed from
a known, non-GE stock (Krueger, 2007; Kuepper, 2002; NCAT, 2003).


Methods for limiting gene flow between GE and organic corn are well understood and are in


place not only in farms using organic production methods, but also those systems producing


specialty com varieties, such as waxy, sweet, and high amylopectin com. As noted by Ronald


and Fouche (2006), "While 100% purity (zero tolerance for any undesired components) is very


48

---
difficult to attain for any agricultural commodity, standard procedures involving spatial
separation, border rows, planting dates, maturity dates, cleaning of equipment, and post-harvest
handling have traditionally been able to provide products that meet diverse market
requirements." The same mechanisms are used to mitigate gene flow between GE and organic
corn systems (Thomison, 2011). The NOP specifically discusses buffer zones and defines them
as areas located between a certified organic production operation and an adjacent land area that
is not maintained under organic management. A buffer zone must be sufficient in size or other
features (e.g., windbreaks or a diversion ditch) to prevent the possibility of unintended contact
with prohibited substances applied to adjacent land areas and the organic grower can incur costs
associated with the establishment ofthese buffer zones. Despite any potential economic harm
resulting from gene flow that organic producers in the target introduction area (Great Plains
states) of MON87460 may encounter, it is clear that organic corn acreage is increasingly steadily
in spite ofconcurrent increases and overwhelming adoption of GE corn production, suggesting
that current methods to limit corn gene flow are sufficient and that the large presence of GE corn
has not stopped the cultivation of corn by organic methods (Figure Rl). As discussed in Chapter


4.5.2 of the EA and the MON87460 corn PPRA (USDA-APHIS, 2010), MON87460 corn does
not differ in reproductive characteristics from conventional corn; consequently, established
methods that have been proven successful in mitigating gene flow between corn varieties are
likely to be as effective if MON87460 were cultivated. .


Figure R4. Acreage of corn produced by GE or organic production methods in the Great


Plains States*, 2000 - 2008.


25000000
20000000

Q.l


bI)


I'll

15000000


Q.l...


<

u

10000000

w


(!)

5000000
0


- Great Plains states ­


GE

.,

..


..... Great Plains states ­
Organic


-

-


.....

.....

'

,

.....

.....


40000


0


30000

~


IlQ

III


::::J


n'


20000

»


n


~


1"11


10000

III


IlQ


1"11


0


2000 2001 2002 2003 2004 2005 2006 2007 2008


Year


*

Great Plains states evaluated included Kansas, Nebraska, North Dakota, South Dakota, and Texas. GE com
adoption data for other Great Plains states were unavailable from USDA-ERS

{J.

Moore, personal
communication). Data collected from (USDA-ERS, 20IOa, 201 Ob; USDA-NASS, 2011 b).

The possible cost to organic producers resulting from proximity to GE-based agriculture is
dependent upon the acceptable level of GE material that may be inadvertently present and on
consumers' expectations and perceptions. The NOP identifies four levels of product composition
for organic agriculture certification

(7

CFR 205.301): 1) 100 percent organic; 2) 95 percent or


49

more organic; 3) 70 to 95 percent organic; and 4) less than 70 percent organic. A third party
organic certification system based on thresholds is also in place to reassure organic customers
(Non-GMO-Project,201O). If there is a negative public perception ofthe adventitious presence
of GE material in organically-produced products, profitability of an organic enterprise may be
diminished through the loss of price premiums earned by these products. Survey evidence
presented in the Brookes and Barfoot (2004a) study showed that the vast majority (92 percent) of


U.S. organic farmers had not incurred any direct additional costs or incurred losses due to GE
crops having been grown near their crops. According to the report, four percent had experienced
lost organic sales or downgrading ofproduce as a result of GE organism presence and the
remaining four percent of farmers had incurred small additional costs only for testing. However,
as observed in Apted and Mazur (2007), the Brookes and Barfoot (Brookes and Barfoot, 2004a)
study was not able to quantify the impact of measures undertaken by organic producers to avoid
GE material coming into contact with organic crops. Nonetheless, there is data to indicate that
farmers using organic production systems are being compensated for the unidentified costs
associated with meeting any contractual obligations and NOP standards for corn produced
through organic systems. For example, in 2008, conventional corn averaged $4.06/bushel
(USDA-NASS, 2011a), whereas organic corn averaged $9.69Ibushel in the same time period
(USDA-ERS, 2011).


There are millions of acres planted to corn and other crops throughout the U.S. each year, and yet
instances such as those mentioned by the commenter (e.g., StarLink), are rare relative to the
number of regulated GE plants in confined field tests. Therefore, it is reasonable to assume that
coexistence practices can be sufficient to maintain the integrity of a crop and the purity of seed,
especially if there are economic/market motivations to implement coexistence practices, e.g., for
organic farmers who receive higher price premiums for their crop (Ronald and Fouche, 2006). In
terms of purity, for example, a bag of "pure" seed corn will cost $100 per bag, whereas one that
exceeds the 5% tolerance is worth $2 per bag (Fernandez and Polansky, 2006).


References


AOSCA (2003) Aosca: 99% Non-Gmo Corn Grain Program Requirements. American
Association of Seed Certifying Agenicies. Retrieved March 2011, from


http://v,,'Ww.identitvpreserved.com/hal1dboo~Laosca-nongmocorn.htm


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


Apted S and Mazur K (2007) Potential Impacts from the Introduciton of Gm Canola on Organic
Farming in Australia, Abare Research Report 07.11. Prepared for the Australian
Government Department of Agriculture, Fisheries and Forestry. Retrieved October, 2011


from http://adl.brs.gov.au/data/warehollse/pe abare99001362/0rganic farming.pdf
Brookes G and Barfoot P (2004a) Co-Existence in North American Agriculture: Can Gm Crops
Be Grown with Conventional and Organic Crops? Dorchester, UK: PG Economics Ltd.
Brookes G and Barfoot P. (2004b) Coexistence ofGm and Non-Gm Crops: Case Study of Maize
Grown in Spain. Dorchester, Uk: Pg Economics Ltd.


Fernandez M and Polansky A. (2006). Presented at Peaceful Coexistence Among Growers of:
Genetically Engineered, Conventional, and Organic Crops. Summary of a Multi­
Stakeholder Workshop, Boulder, CO.


50

Gealy D, Bradford K, Hall L, Hellmich R, Raybould A, Wolt J, and Zilberman D (2007)
Implications of Gene Flow in the Scale-up and Commercial Use of Biotechnology­
Derived Crops: Economic and Policy Considerations. Council for Agricultural Science
and Technology (CAST).


Krueger JE (2007) If Your Farm Is Organic, Must It Be Gmo-Free? . Farmers' Legal Action
Group, Inc. Retrieved from


http://www .f1aginc.org/topics/pubs/ alts/Organ i csAndG M Os2007.

pdf


Kuepper G (2002) Organic Field Com Production. National Sustainable Agricultural
Information Service. ATTRA. Retrieved from bttp:l/attra.ncat.org/attra­
pub/PDFlfieldcorn.pdf


NCA T (2003) Neat's Organic Crops Workbook: A Guide to Sustainable and Allowed Practices.


Retrieved from http://attra.ncat.org/attra-pub/PDFlcropsworkbook.pdf


Non-GMO-Project (2010) Non-Gmo Project. Retrieved July 31, 2010, from


http://www .nongmoproject.orgl


Ronald P and Fouche B (2006) Genetic Engineering and Organic Production Systems.
University of California, Agriculture and Natural Resources. Retrieved September 2011,


from http://ucanr.of!z/freepubs/docs/8188.pdf


Thomison P (2011) Managing "Pollen" Drift to Minimize Contamination of Non-Gmo Com,


Agf-153. Retrieved October, 2011 from http://ohioline.osu.edu/agf-fact/0153.html


USDA-AMS-NOP (2011) What Is Organic? United States Department of Agriculture,
Agricultural Marketing Services, National Organic Program. Retrieved October, 2011
from


http://www.ams.usda.gov/AMSvl.O/ams.fetchTemplateData.do?template=TemplateC&n


avfD=NationaIOrganicProe:ram&leftNav=NationaIOre:anicProe:ram&page=NOPConsum
ers&description=Col1sumers&acct=nopgeninfo


USDA-AMS (2011) Policy Memorandum. Washington DC: United States Department of
Agriculture, Agricultural Marketing Services, National Organics Program.


USDA-APHIS (2010) Plant Pest Risk Assessment for Mon 87460 Com. Riverdale, MD: APHIS
-Animal and Plant Health Inspection Service. Retrieved from


http://w\vw.aphis.usda.gov!biotechnology/notreg.htm

I


USDA-ERS (2010a) Adoption of Genetically Engineered Crops in the U.S.: Com Varieties.
Retrieved Aug. 11 2010, from


http://www.ers.usda.gov/DataiBiotechCrops/ExtentofAdoptionTablel.htm
USDA-ERS (20 lOb) Organic Production. Retrieved February 2011, from


http://www.ers.usda.gov/Data/Organic/
USDA-ERS (2011) Organic Prices. United States Department of Agriculture, Economic
Research Service. Retrieved October, 2011 from


http://w\vw .ers.usda.gov Idata/OrganicPrices/


USDA-NASS (2011a) Crop Values -2010 Summary. 1449-0372. United States Department of
Agriculture, National Agricultural Statistics Service. Retrieved October, 2011 from


http://usda.mannlib.comeILedu/usdalcurrentiCrop ValuSu/Crop ValuSu-02-16-20

II.pdf


USDA-NASS. (2011b) Quick Stats 2.0. Retrieved October, 2011 from United States
Department ofAgriculture, National Agricultural Statistics Service


http://quickstats.nass.usda.gov /
51

Comment 22: Several commenters expressed concern that the adventitious presence of GE
traits has deterred farmers from producing corn through organic methods, thus reducing
the capacity of the organic industry from growing due to supply issues. As justification for
this, one commenter quoted an organic grain handler explaining that they are unable to
supply organic corn because of unreliable separation between organic and GE corn
production.


Response 22:
APHIS supports all forms ofagricultural production, whether it is organic,
conventional, or GE production methods. Additionally, as stated in the EA, APHIS
acknowledges that there may be a lag between supply and demand of organic corn. However,
assigning the presence of GE corn as the major or only factor preventing further organic corn
production is not consistent with observations about the economic and market successes of
organic crops. Even the same commenter suggests GE corn production may prevent organic
corn adoption concedes that "it is unclear why more U.S. farmers are not growing organic corn."
Just as demonstrated for several other organic commodities, such as coffee or nuts, short supplies
have been noted, although many of these do not have any commercialized GE varieties (Greene
et aI., 2009).


As stated in Chapter 4.3.3.2 ofthe EA, organic corn production continues to increase in the U.S.
despite the presence of corn produced through excluded methods. This trend demonstrates the
capacity of current organic system plans to avoid the use ofexcluded methods and the efficacy of
these plans to increasingly produce organic agricultural commodities for target markets.
Additionally, the same organic grain handler cited by the commenters is also cited as providing
other reasons for the tight supply oforganic agricultural commodities, including: 1) the three­
year transition requirement for organic production; 2) fewer organic marketing outlets; 3) the
need for on-farm storage; 4) the lack ofthird-party contractors for organic pest and nutrient
management; 4) heavy and intensive production requirements; 5) fear of criticism from
neighbors; 6) unknown risks; 7) an absence of supporting government infrastructure; 8) and
subsidies for ethanol that increase demand for conventional production and supply (Greene et aI.,
2009). Furthermore, Brookes and Barfoot (2004) also noted in an examination oftrends in the
planting of GE and organic crops that the growth ofthe crop area used for GE plants has not
impeded the development ofthe organic sector in North America. The U.S. had under a million
acres of certified organic farmland when Congress passed the Organic Foods Production Act of
1990. By the time USDA implemented national organic standards in 2002, certified organic
farmland had doubled, and doubled again between 2002 and 2005 (USDA-ERS, 2010). The U.S.
total number ofcertified organic producers in 2000 was 6,592; this number increased to 10,159
in 2007 (USDA-ERS, 2010). Thus, due to the presence of all these possible preventative factors
and the concurrent growth of both organic and GE com sectors, it is unlikely that a determination
ofnonregulated status ofMON87460 will not have any impact on the growth ofthe organic corn
industry.


References
Brookes G and Barfoot P (2004) Co-Existence in North American Agriculture: Can Gm Crops
Be Grown with Conventional and Organic Crops? Dorchester, UK: PG Economics Ltd.


52

Greene C, Dimitri C, Lin B-H, McBride W, Oberholter L, and Smith T (2009) Emerging Issues


in the U.S. Organic Industry. USDA-ORS. Retrieved October 201 I, from


http://www.ers.usda.gov/publications/cib55/cib55.pdf


USDA-ERS (2010) Organic Production. Retrieved February 20 11, from


http://www.ers.usda.gov/Data/Organic/
Comment 23: Several commenters expressed concern that cultivation of MON87460 corn,
either alone or stacked with other commercially-available GE traits, would lead to a
general increase pesticide application. Additionally, several commenters also expressed
concern that the presence of a GE corn variety stacked with MON87460 and glyphosate­
tolerance traits will lead to an increase in incidents of glyphosate-resistant weeds.


Responses 23: While it was stated that Chapter 4.3.2.2 ofthe EA that cultivation of MON87460
may result in a shift away from glyphosate use, it was also stated that this shifts is likely to be
limited through stacking of the MON87460 trait with commercially-available herbicide-tolerant
traits (USDA-APHIS, 2011). In fact, Monsanto does not plan on marketing MON87460 as a
stand-alone product, suggesting that stacking of MON87460 with GE herbicide-tolerant traits is
very likely (Monsanto, 2010). The Cumulative Impacts section (Chapter 5) of the EA has been
rewritten to further clarify this point and address commenter concern that the stacking oftraits
will lead to an increase in pesticide application. Due to similar management strategies between
any stacked hybrid progeny and their parent varieties (e.g., hybrid progeny and one of the parent
varieties will possess herbicide tolerance), overall pesticide application will remain relatively
unchanged and is not likely to increase beyond that which can be expected from projected
increases in com cultivation. Other agricultural inputs, such as fertilizer application, will likely
slightly increase as welL


Weed management is an important part of any agricultural system. The commercialization of
com varieties stacked with glyphosate-tolerant and the MON87460 traits would permit existing
and widely-adopted management strategies to continue. Relying on glyphosate alone as the only
weed-removal strategy may influence the number of weed species that may become glyphosate­
resistant. However, as this same commenter concedes, "These specific risks are not unique to
MON87460" and may be influenced by a number of other factors involved in the evolution of
glyphosate resistance in weeds. A variety of genetic, biological/ecological, and operational
factors contribute to the evolution of herbicide resistance in weeds. Genetic factors include the
frequency of genes in a particular weed species that promotes resistance to a particular herbicide,
the mechanism ofresistance and the capacity of genes to facilitate this resistance, how resistance
is inherited, and the fitness of the weed in the presence and absence ofthe herbicide (Georghiou
and Taylor, 1986; Neve, 2008). Biological/ecological factors include the method of weed
reproduction, seed production capacity, seed bank turnover, and the amount and frequency of
gene flow between weed populations (Jasieniuk et ai., 1996; Maxwell and Mortimer, 1994).
Collectively, these issues illustrate that different plant species may present different risks of
resistance. Operational factors influencing development ofweed resistance include farm-level
management practices such as the chemistry ofthe applied herbicide and its respective


53

mechanism ofaction, and the application rates/frequency ofherbicide application (Georghiou
and Taylor, 1986; Jasieniuk et aL, 1996).


Currently, there are no concrete data, information, or models that provide a prescriptive
determination on the evolution of herbicide resistance in specific weeds or the efficacy of a
particular management strategy to prevent the evolution of resistance to glyphosate. APHIS is
not aware of any models that simulate the evolution of weed resistance to glyphosate in
herbicide-tolerant agricultural systems. What can be generally observed, however, is the
influence a management strategy exerts in the evolution of herbicide resistance in weeds. With
regard corn varieties stacked with MON87460 and glyphosate resistance, it is unlikely that this
GE hybrid corn variety would alter any baseline influence of established management strategies
that are currently practiced in GE corn cultivation systems. Thus, it is unlikely that any GE corn
hybrid variety stacked with MON87460 would increase the incidence of glyphosate resistant
weeds, as the factors resulting in of glyphosate resistance in weeds would remain unchanged.
Chemistry ofthe applied herbicide (e.g., glyphosate) and the frequency and rate of application
would remain unchanged, as any progeny GE corn variety containing both MON87460 and
glyphosate-tolerant traits would possess the same glyphosate-tolerant trait as its parent variety,
and thus, require similar weed management.


References
Georghiou G and Taylor C. (1986) Factors Influencing the Evolution of Resistance Pesticide


Resistance: Strategies and Tacticsfor Management (pp. 157-169). Washington DC:


National Academy Press.
Jasieniuk M, Brule-Babel AL, and Morrison IN. (1996) The Evolution and Genetics of Herbicide
Resistance in Weeds. Weed Science, 44(1), 176-193.
Maxwell B and Mortimer A. (1994) Selection for Herbicide Resistance. In S Powles and
J


Holtrum (Eds.), Herbicide Resistance in Plants: Biology and Biochemistry (pp. 1-25).


Baco Raton, FL: CRC Press.
Monsanto (2010) Petition for the Determination ofNon regulated Status for Mon 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://www.aphis.usda.gov/biotechnologv/notreg.html).
Neve P. (2008) Simulation Modeling to Understand the Evolution and Management of
Glyphosate Resistance in Weeds. Pest Management Science, 64,392-401.
USDA-APHIS (2011) Petitions for Nonregulated Status Granted or Pending by Aphis. United
States Department of Agriculture -Animal and Plant Health Inspection Service.
Retrieved September,

2011 from http://www.aphis.lIsda.gov/biotechnology/not reg.html


Comment 24: Concern was expressed by commenters that MON87460 corn would


generally harm soil microorganisms and that soil and water quality would suffer if

MO~87460

corn were stacked with commercially-available GE corn varieties that possess
insect resistance (Bt protein production) and/or herbicide-tolerance (e.g., glyphosate­
tolerance) traits.


54

Response 24: APHIS disagrees that MON87460 would harm soil organisms. As detailed in
Chapter 4.4.2.2 of the EA, microbial soil populations may encounter the NPTII and CSPB
proteins produced by MON87460 corn through degrading plant material in the field or the in situ
root system. Both expressed proteins in MON87460 corn (NPTU and CSPB) have been shown
to be safe for the environment (Monsanto, 2010). In particular, the NPTII protein has been used
in a variety of GE crops without any adverse effect on the environment. APHIS refers any
commenter to the EA and response #16 ofthis FONSI for further discussion about the relative
safety ofMON87460 corn and its expressed proteins. Additionally, compositional analysis of
MON87460 corn reveals that it is similar to conventional corn, with no meaningful biological
differences (USDA-APHIS, 2010), thus suggesting that there would not be any differences in
availability of nitrogen or other nutrients following the degradation ofplant material in the field.


As discussed in Chapter 5 of the EA, MON87460 will likely be stacked with commercially­
available GE corn traits. The two most common GE corn traits include glyphosate tolerance and


insect resistance. The glyphosate-tolerant phenotype permits the appl ication of the herbicide
glyphosate in order to control weeds. Glyphosate adsorbs strongly to soil, does not generally
move vertically below six inches through the soil, and typically possesses a half-life of less than
60 days (Giesy et aI., 2000). Glyphosate can also either inhibit or mobilize various elements,
including AI, Fe, Cu, Zn, Ni, P, Si, and As in soil, depending on various factors such as the
amount of clay or organic matter (Barrett and McBride, 2006). Soil microbial populations
readily degrade glyphosate into aminomethylphosphonic acid (AMPA), a degradation product.
Observed AMP A concentrations in glyphosate-treated areas are many times lower than levels
with potentially adverse effects (Gimsing et aI., 2004; USDA, 2003). While some data has
indicated that many microorganisms produce aromatic amino acids through the same metabolic
pathway that glyphosate inhibits in plants, there is little empirical evidence to support the
conclusion that glyphosate can negatively impact soil microbes; on the contrary, some field
studies have shown an increase in microbial activity (USDA-FS, 2003). Thus, the application of
glyphosate itself is unlikely to significantly impact soil microbial populations and their
respective activities that influence soil quality. In addition to glyphosate tolerance, MON87460
may also be stacked with various commercially-available Bt proteins that confer specific insect­
resistant phenotypes. Bt proteins are a family of proteins produced by Bacillus thuringiensis that
exhibit specificity for either Lepidopteran or Coleopteran pests of corn. Soil organisms may be
exposed to Bt through decaying plant material from or the root system of Bt-expressing plants.
Evidence shows that Bt proteins have no measurable effect on soil microbial populations, of
either bacteria, actinomycetes, fungi, protozoa, algae, or nematodes (Mendelsohn et aI., 2003).
APHIS agrees that weed management strategies can impact soil and water quality, such as tillage
affecting runoff and soil loss. The majority of corn cultivated in the U.S. is managed using
glyphosate tolerant varieties, and these have been shown to have ecological advantages over
those not managed predominantly with glyphosate (Fernandez-Cornejo et aI., 2009). As
discussed in Chapter 5 of the EA, no direct impact on current corn pest management practices is
likely to result from hybrid corn progeny stacked with MON87460 and/or herbicide-tolerant
and/or insect-resistant traits. MON87460 expressing these GE hybrid corn traits would require
similar management strategies as the parent varieties. Stacked corn varieties with MON87460
are intended to be replacement products for GE corn varieties possessing herbicide tolerance
and/or insect resistance in its target range; thus, no increase or shift in pesticide application is


55

expected, nor is any alteration anticipated in tillage. These two factors may influence soil and
water quality and will remain unchanged from current practices if stacked com varieties with
MON87460 were cultivated. Furthermore, compositional analysis of both MON87460 and
commercially-available GE corn varieties demonstrated that they are not dissimilar (USDA­
APHIS, 2010, 2011); consequently, any progeny derived from these varieties and MON87460 is
unlikely to be compositionally different from its respective parent varieties and unlikely to
significantly impact soil organisms through degradation of plant tissue in the field.


In summary, no significant impact to soil and water quality is expected from the stacking of
MON87460 with herbicide-tolerant and/or insect resistant traits, as there is no reason to expect
that this GE hybrid corn would be compositionally different from currently-available corn
varieties. MON87460 corn would require similar management conditions already in place in
conventional corn production systems. Evidence in the literature demonstrates no toxicity for
either glyphosate or Bt proteins on soil microorganisms.


References
Barrett KA and McBride MB. (2006) Trace Element Mobilization in Soils by Glyphosate. Soil
Science Society ofAmerica, 70(6), 1882-1888.


Fernandez-Cornejo

1,
Nehring R, Sinha EN, Grube A, and Vialou A. (2009) Assessing Recent
Trends in Pesticide Use in Us. Agriculture. Paper presented at the Meeting of the
AAEA, Milwaukee, WI.


Giesy J, Dobson S, and Solomon K. (2000) Ecotoxicologicai Risk Assessment for Roundup
Herbicide. Reviews ofEnvironmental Contaminaton and Toxicology (167),35-120.


Gimsing AL, Borggaard OK, Jacobsen OS, Aamand J, and Smensen J. (2004) Chemical and
Microbiological Soil Characteristics ControlJing Glyphosate Mineralisation in Danish
Surface Soils. Applied Soil Ecology, 27(3), 233-242.


Mendelsohn M, Kough J, Vaituzis Z, and Matthews K. (2003) Are Bt Crops Safe? Nature
Biotechnology, 21(9), 1003-1009.


Monsanto (2010) Petition for the Determination of Nonregulated Status for Mon 87460.
Submitted by W. R. Reeves, Regulatory Affairs Manager. The Monsanto Company (See


Table http://www .aphis. usda.gov/biotechnologv /not reQ.html).


USDA-APHIS (2010) Plant Pest Risk Assessment for Mon 87460 Com. Riverdale, MD: APHIS
-Animal and Plant Health Inspection Service. Retrieved from


http://www.aphis.usda.gov/biotechnology/notreg.html


USDA-APHIS (2011) Petitions for Nonregulated Status Granted or Pending by Aphis. United
States Department of Agriculture -Animal and Plant Health Inspection Service.


Retrieved September, 2011 from http://www.aphis.usda.gov/biotechnology/notreg.html


USDA-FS (2003) Glyphosate -Human Health and Ecological Risk Assessment: Final Report.
United States Department of Agriculture Forest Service. Retrieved October, 2011 from


http://teamarun<!o.org!control manage/docs/04a03 glvphosate.pdf


USDA (2003) Glyphosate Human Health and Ecological Risk Assessment Final Report.
Prepared by Syracuse Environmental Research Associated, Inc for Usda, Forest Service
Health Protection. United States Department of Agriculture.


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Created Date12/19/2011 6:51:12 AM