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 of cold 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-peerreviewed 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 nonGE 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 

regulated field trials (USDA-APHIS 2010) 

8 

AttributelMeasure Alternative A: No Actiou Alternatiye B: Determination 

of Nonregulated Status 

Acreage and Areas of Corn 

Production Unchanged Minimal 

Cropping practices Unchanged Unchanged 

Pesticide use Unchanged Unchanged 

Seed Corn Production Unchanged Unchanged 

Organic Farming Unchanged Unchanged 

Impact to Specialty Corn Unchanged Unchanged 

Environment 

Water use Unchanged Unchanged 

Soil Unchanged Unchanged 

Air Quality Unchanged Unchanged 

Climate Change Unchanged Unchanged 

Animals Unchanged Unchanged 

Plants Unchanged Unchanged 

Biological Diversity Unchanged Unchanged 

Gene Movement Unchanged Minimal 

Human and Animal Health 

Risk to Human Health Unchanged Unchanged 

Risk to Worker Safety Unchanged Unchanged 

Risk to Animal Feed Unchanged Unchanged 

Socioeconomic 

Domestic Economic 

Environment Unchanged Unchanged 

Trade Economic 

Environment Unchanged Unchanged 

Social Environment Unchanged Unchanged 

Other U.S Regulatory 

Approvals 

FDA completed 

consultations 

FDA completed 

consultations 

Compliance with Other Laws 

CWA, CAA, EOs Fully compliant 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 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 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 of a determination of nonregulated 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 of environmental, 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 noncited 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. cornimporting 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 

MON874601 Split Plot TX 

ControlI Split Plot TX 

MON874602 Strip plot TX 

Controf Strip plot TX 

Water-sufficient 

MON874603 Split Plot TX 

Controe Split Plot TX 

MON874604 RCB KS+NE 

Control4 RCB KS+NE 

MON874605 RCB NE 

Control5 RCB NE 

MON874606 Strip plot KS+"N'E+TX 

Control6 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 watersufficient 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 crossincompatibility 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 Agrobacteriummediated 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.h1m1 

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 I 0) 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 farreaching 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 waterlimiting 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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(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 

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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 of current 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 DroughtTolerant 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 humanconsumed 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 I 0) 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 peerreviewed 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 dosedependent 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 SoybeansRevisiting 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 CommissionDirectorate 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, naturalIyoccurring 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 of a 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 shortcomings 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 Cry lab 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-aboutgenetically-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 of an individual organic system plan required for 

NOP certification has proven effective in preventing the presence of excluded 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 of corn 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 of concurrent 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 

III 10000 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 MultiStakeholder 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 BiotechnologyDerived 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/attrapub/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 of agricultural 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 of excluded 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 threeyear 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 of certified 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 glyphosatetolerance 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 glyphosateresistant. 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 of action, and the application rates/frequency of herbicide 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., glyphosatetolerance) 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 commerciallyavailable 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 insectresistant 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 (USDAAPHIS, 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. 

56