### NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND FINDING OFNO SIGNIFICANT IMPACT

MONSANTO COMPANY EVENT MON 87460 

### CORN

United States Department ofAgriculture Animal and PlantHealth Inspection Service Biotechnology Regulatory Services

The United States Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has developed this decision document to comply with the requirements ofthe National Environmental Policy Act (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementingNEPA, and the USDA APHIS' NEPA implementing regulations and procedures. This NEPA decision document, a Finding ofNo Significant Impact (FONSI), sets forth APHIS' NEPA decision and its rationale. Comments from the public involvementprocess were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementingNEPA (7 CFR part 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated
status ofapetition 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 ofthe 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.



### RegulatoryAuthority "Protecting American agriculture" is the basic charge ofAPHIS. APHIS provides leadership in ensuring the health and care ofplants and animals. The agency improves agricultural productivity and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural 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 FR23302,57 FR22984). The Coordinated Framework, published by the Office ofScience and Technology Policy, describes the comprehensive federal regulatory policy for ensuringthe safety ofbiotechnology research and

I Under NEPA regulations, the "human environment" includes "the natural and physical environment and the relationship ofpeople with that environment" (40 CFR §50S.14).products and explains how federal agencies will use existing Federal statutes in a mannerto

ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth ofthe biotechnology industry. The Coordinated Framework is based on several important guiding principles: (I) agencies should define those transgenic organisms subjectto review to the extentpermitted by theirrespective 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 ofGE 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 plantpestprovisions in the PlantProtection Act of2000, as amended (7 USC 

### § 7701 etseq.) to ensure that they do not pose a plantpest risk to the environment.

The FDA regulates GE organismsunder the authority ofthe Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and proper labeling ofall plant-derived foods and feeds, includingthose that are genetically engineered. To help developers offood and feed derived from GE crops comply with their obligations under Federal food safety laws, FDA encourages them to participate in a voluntary consultationprocess. All food and feed derived from GE crops currently on the market in the United States have successfully completedthis consultationprocess. The FDA policy statement concerningregulation ofproducts derived from

new plantvarieties, including those genetically engineered, was published in the Federal Register

on May 29, 1992 (57 FR22984-23005). Under this policy, FDA uses what is termed a consultationprocess to ensure thathuman food and animal feed safety issues orother regulatory issues (e.g., labeling) are resolved priorto commercial distribution ofbioengineered food.

The EPA regulates plant-incorporated protectants underthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues ofpesticides on and in food and animal feed, or establishes an exemption from the requirementfor a tolerance, underthe 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 ofmodem 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 ofGE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuantto 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) ofcertain GE organisms and products. A GEorganism is no longer subjectto the plantpestprovisions ofthe PlantProtection Act orto the regulatory requirements of7 CFRpart 340 when APHIS

2determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, orvector agent used in engineering the organism belongs to one ofthe taxa listed in the regulation (7 CFR340.2) and is also considered

a plant pest. A GE organism is also regulated underPart 340 when APHIS has reason to believe thatthe GE organism may be a plantpest orAPHIS does not have information to determine if the GE organism is unlikely to pose a plantpest risk.

A person may petition the agency that a particular regulated article is unlikely to pose a plant pestrisk, and, therefore, is no longerregulated underthe plantpestprovisions ofthePlant ProtectionAct or the regulations at 7 CFR 340. The petitioner is required to provide information under 

### § 340.6(c)(4) related to plantpest risk thatthe agency may use to determine whetherthe regulated article is unlikely to present a greaterplant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Actwhen APHIS determines that it is unlikely to pose a plant pestrisk.



### APHIS' Responseto Petition for Nonregulated Status Under the authority ofthe plantpest provisions ofthe Plant Protection Act and 7 CFRPart 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 ofthe regulated status ofGE organisms, including GE plants such as MON 87460. When a petition for nonregulated status is submitted, APHIS must make a determination ifthe GE organism is unlikely to pose a plantpest risk. IfAPHIS determines based on its Plant PestRisk Assessment (PPRA) thatthe genetically engineered organism is unlikely to pose a plantpestrisk, the genetically engineered organism is no longer subjectto the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340.

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



### Monsanto EventMON 87460 

### Corn MON 87460 is designed to mitigate grain yield loss under water-limited conditions. Asdetailed in the Monsanto petition, the enhanced droughttolerance ofMON 87460 results from the introduction and controlled expression ofcold shockprotein B (cspB), a native ribonucleic acid (RNA) chaperone derived from Bacillus subtilis (Monsanto, 2010). The enhanced drought tolerantphenotype ofMON 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 87460was notnotably 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 ofwater deficiency on photosynthesis, stomatal conductance, and carbon fixation on com growth and development, resulting in an increased number ofkernels perear (Monsanto, 2010).
Drought is one ofthe major limiting factors in com thatprevents realization ofoptimum grain yield worldwide (Boyer, 1982). In North America alone, it is estimated that 40 percent of



### 3distributed crop loss insurance indemnities are due to sub-optimal water availability (Boyer, 1982). In temperate zone areas ofcommercial com production, average global annual losses due
to moderate drought are approximately 15 percent, though losses can be much higher under conditions ofsevere drought (Barker et aI., 2005).

Coordinated FrameworkReview 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 ofproducts 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 offood 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 ofthe EnvironmentalAnalysis The scope ofanalysis 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 ofa determination ofnonregulated
status ofMON 87460 would be less likely because these types ofconversions have not been notable contributorsto cropland overthe past 18 years; therefore, APHIS does not consider them
to be part ofthe affected environment in the EA. Furthermore, as described in Chapter4 ofthe EA, MON 87460 is unlikely to significantly increase future com acreage beyond USDA-ERS projected expansion in irrigated U.S. comproduction regions. The MON 87460 trait is intended
to increase grain yield security under conditions ofmoderate 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 ofcomproduction, APHIS used data from the National Agricultural Statistics Service (NASS) 2007 Census ofAgriculture to determine where com is produced in the United States (USDA, 2009). Com grain was commercially produced in all states except Alaska.

PublicInvolvement On May 11,2011, APHIS published a notice in the Federal Register (76 FR 27303-27304, Docketno. APHIS-2011-0023) announcing the availability ofthe Monsanto petition, and the APHIS PPRA and draft EA for a 60-day public review and commentperiod. Public comments

were initially solicited for a 60-day public commentperiod ending July 11,2011; however, APHIS extended the public commentperiod for an additional 30 days (76 FR44892-44893, docket number APHIS-2011-0023). Comments were required to be received on orbefore August 12,2011. A total of250 comments were received from various groups and individuals during the 90 day commentperiod. The majority ofthe comments (229) opposed the development and use ofgenetically engineered foods and/or MON87460 com, while 21 comments supported a determination ofnonregulated status ofMON87460 com. Three ofthe
comments opposing a determination ofnonregulated status included submitted electronic attachments that consisted either of: a) a single letter signed by numerous people (6,335

4signatures); b) many letters containing identical material (16,742 letters); or c) a consolidated document ofcomments (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=l0;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 ofNo 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 pestprovisions ofthe Plant Protection Act and 7 CFRpart 340, and for this particular EA, the specific petition seeking a determination ofnonregulated status of MON 87460. Issues discussed in the EA were developed by consideringpublic concerns as well as issues raised in public comments submitted for otherenvironmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well asthose issues that have been raised by various stakeholders. These issues, including those regarding the agricultural production ofcom using various production methods, and the environmental and food/feed safety ofgenetically 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 ofcomproduction

• Cropping practices

• Specialty comproduction

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 werefully analyzed The EA analyzes the potential environmental consequences ofa determination ofnonregulated
status ofMON 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, 20I0) APHIS has concluded that MON 87460 is unlikely to pose a plant pestrisk. Therefore APHIS must determine that MON 87460 is no longer subject to 7 CFRpart 340 orthe plantpestprovisions 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 Underthe No Action Alternative, APHIS would deny the petition. MON 87460 and progeny derived from MON 87460 would continue to be regulated articles underthe 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 iftherewere insufficient evidence to demonstrate the lack ofplant pest risk from the unconfined cultivation of MON 87460.

This alternative is notthe preferred alternative because APHIS has concluded through a PPRA (USDA-APHIS, 2010)that MON 87460 is unlikelytopose a plant pest risk. Choosingthis alternative would not satisfy the purpose and need ofmakinga determination ofplantpestrisk
status and respondingto the petition for nonregulated status.



### PreferredAlternative: DeterminationthatMON 87460 cornis No Longera Regulated Article Underthis alternative, MON 87460 and progeny derived from them would no longer be regulated articles underthe regulations at 7 CFRPart 340. MON 87460 is unlikely to pose a plantpestrisk (USDA-APHIS, 2010). Permits issued ornotifications acknowledged by APHIS would no longerbe 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 CFRpart 340 and the agency's authority underthe plant pest provisions ofthe PlantProtection Act. Becausethe agency has concluded that MON 87460 is unlikely to pose a plant pest risk, a determination ofnonregulated status of MON 87460 is a response that is consistent with the plant pest provisions ofthe PPA, the regUlations codified in 7 CFRpart 340, and the biotechnology regulatory policies in the Coordinated Framework. Under this alternative, growers may havefuture accessto MON 87460 and progeny derived from this event ifthe developer decides to commercialize MON 87460.



### Alternatives ConsideredbutRejectedfrom Further Consideration APHIS assembled a list ofalternatives that might be considered for MON 87460. The agency evaluated these alternatives, in light ofthe agency's authority under the plant pestprovisions of the Plant Protection Act, and the regulations at 7 CFRpart 340, with respect to environmental safety, efficacy, and practicality to identify which alternatives would be further considered for

6MON 87460. Based onthis evaluation, APHIS rejected several alternatives. These alternatives

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



### ProhibitanyMON87460 from being released In response to public commentsthat stated a preference that no GE organisms enterthe marketplace, APHIS considered prohibitingthe 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 ofproducts regulated under [the Plant Protection Act] shall be based on sound science

... §402(4).

On March 11, 2011, in a Memorandum for the Heads ofExecutive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broadprinciples, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemerging technologies (such as genetic engineering)
atthe agency level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistentwith thatExecutive Order, the following principle, among others, to the extent permitted by law, when regulating emerging technologies:

"[D]ecisions should be based on the bestreasonably obtainable scientific, technical, economic, and other information, within the boundaries ofthe authorities and mandates ofeach agency"

Based on ourPlant Pest Risk Assessment (USDA-APHIS, 2010) andthe scientific data evaluated therein, APHIS has concluded that MON 87460 is unlikely topose a plantpestrisk. Accordingly, there is no basis in science for prohibiting the release ofMON87460.



### Approve thepetition inpart The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition inwhole

orinpart." Forexample, a determination ofnonregulated status in part may be appropriate if there is a plantpestrisk associated with some, but not all lines described in a petition. Because APHIS has concludedthatMON 87460 is unlikelytopose a plantpest risk, there is no regulatory basis under the plant pestprovisions ofthe Plant Protection Act for considering approval ofthe petition only in part.



### Isolation distance betweenMON87460 andnon-GE corn andgeographical restrictions In response to public concerns ofgene 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 concludedthat MON 87460 is unlikely to pose a plantpest risk (USDA-APHIS, 2010), an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plantpest provisions ofthe Plant Protection Actand regulations in 7 CFRpart 340.

7APHIS also considered geographically restricting the production ofMON 87460 based on the location ofproduction ofnon-GE com in organic production systems orproduction systems for GE-sensitive markets in response topublic 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 plantpest 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 plantpestrisk, and will not exhibit a greaterplantpestrisk in any geographically restricted area. Therefore, such an alternative would not be consistent with APHIS' statutory authority under the plantpestprovisions ofthe PlantProtection Act and regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordinated Framework.

Based on the foregoing, the imposition ofisolation distances orgeographic restrictions would
not meet APHIS' purpose and need to respond appropriately to a petition for nonregulated
status based on the requirements in 7 CFRpart 340 and the agency's authority under the plant pestprovisions ofthe Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. However, individuals might choose on their ownto geographically isolate their nonGE comproductions systems from MON 87460 orto use isolation distances and other management practicesto minimize gene movement between com fields. Information to assist growers in making informed management decisions for MON 87460 is available from Association ofOfficial Seed Certifying Agencies (AOSCA 2009).



### RequirementofTesting ForMON87460 During the commentperiodsfor otherpetitions for nonregulated status, some commenters requested USDA to require and provide testing for GE products in non-GEproduction systems. APHIS notes there are no nationally-established regulations involving testing, criteria, or limits ofGE material in non-GE systems. Such a requirementwould be extremely difficult to implement and maintain. Additionally, because MON 87460 does notpose a plantpest risk (USDA-APHIS, 2010), the imposition ofany type oftestingrequirements is inconsistent with the plant pest provisions ofthe PlantProtection Act, the regulations at 7 CFRpart340 and biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a requirementfor MON 87460 would not meet APHIS' purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.



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

Satisfied through use of Satisfied

- risk assessment

regulated field trials (USDA-APHIS 2010)

8AttributelMeasure Alternative A: No Actiou Alternatiye B: Determination ofNonregulated Status Acreage and Areas ofCorn 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 OtherLaws CWA, CAA, EOs Fully compliant Fully compliant *Unchanged

- no slgmficant change expected *Minimal

- possibly small changes but no significant differences

9Finding ofNo Significant Impact The analysis in the EA indicates that there will not be a significant impact, individually or cumulatively, on the quality ofthe human environment as a result ofthis 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 commerciallyproduced in all U.S. states except Alaska (USDA, 2009). During the 2009/2010 market year, 86.4 million acres ofcorn were planted and approximately 13.1 billion bushels ofcom were harvested in the U.S. with 86 percent ofall corn planted in 2010 representing a GE variety (USDA-ERS, 2010; USDA-ERS, 2010a). Ofthe 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 ofthe EA, MON 87460 would be cultivated in areas that already supporteconomically viable com production. MON 87460 does not exhibittraits that would allow it to establish outsidethe agricultural environment. MON 87460 trait is intended to increase grain yield security under conditions ofmoderate 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 comproduction. 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 ofgrassland, forest, or other land types to cropland as a result ofa determination ofnonregulated status of MON 87460 would be less likely because these types ofconversions have not been notable contributors to cropland over the past 18 years. A determination ofnonregulated status ofMON 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 ofGE 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 ofcorn hybrid varieties that are readily available to growers.
intensity

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

1. impacts that may be both beneficialandadverse. A determination ofnonregulated status ofMON 87460 will have no significant environmental impact in relation to the availability ofGE, conventional, organic or specialty comvarieties. As discussed in Chapter 4 ofthe EA, a determination of nonregulated status ofMON 87460 is not expectedto directly cause an increase in agricultural acreage devotedto com production beyond projected USDA-ERS increases. The availability ofMON 87460 will not change cultivation areas or cropping practices

10for 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 itto 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 progenyproduced 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 comvariety to the conventional com market and is not expected
to change the availability ofGE and non-GE corn varieties on the market. The projected increase in com acreage that occurs independently ofMON 87460will be sustained by both market demand for cornproducts and the large number ofcorn hybrid varieties that

are readily available to growers. Corn-related farm incomes could increase in areas that adopt MON 87460. The impact ofsuch an increase in returns would be greater for states where farms represent a greater share ofstate gross domestic product and where com represents a greater share ofcrop 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 87460than those incurred by planting non-drought tolerant corn varieties. MON 87460 is designed to provide increased yield security in currentcom-producing areas that are subjectto 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 overtime (Yu and Babcock, 2010), but others have been specially selected for drought tolerance. Therefore, the impacts ofa determination ofnonregulated status ofMON 87460 would
not likely be different from the corn seed optionsthat currently exist. MON 87460 seed could be ofparticular interest to parts ofthe world where corn production suffers from water-limited conditions. To the extentthis interest translates to demand for U.S. MON 87460 seed as a result ofadetermination 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 expectedto be minor ornegligible. Corn from this foreign production could potentially enhance production in drought stressed locations in other countries. 

### 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofMON 87460would have no significant impacts on human oranimal health. The food/feed nutritional and safety assessment for MON 87460 has been reviewed by the FDA. Under the FFDCA, it is the responsibility offood and feed manufacturers to ensure thatthe 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 offood 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 completedtheir consultation on MON 87460 on December 10, 2010 and had no further questions concerning MON 87460 drought tolerant corn (FDA, 2010). Based onthe assessment oflaboratory dataprovided by Monsanto in the

11submitted petition and an analysis ofthe scientific literature (USDA-APHIS, 2010), along with the completion ofthe consultationprocess with FDAregarding the CSPB and NPTII proteins ofMON 87460, APHIS has concluded that a determination of nonregulated status ofMON 87460 would have no adverse impacts onhuman or animal health. 

### 3. Unique characteristics of the geographic area such asproximity to historic orcultural
resources,parklands,prime farmlands, wetlands, wildandscenic rivers, or ecologically criticalareas. There are no unique characteristics ofgeographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas thatwould 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 ordamage to property; do not cause any alterations ofproperty, wildlife habitat, or landscapes; and do
not involve the sale, lease, ortransfer ofownership ofany property. This action is limited to a determination ofnonregulated status ofMON 87460. The productwill be deployed on agricultural land currently suitable forproduction ofcorn, will replace existing varieties, and is not expectedto increase the acreage ofcorn production. Progeny ofthis variety that express the identified traits ofthe MON 87460 will be retained by Monsanto or licensed users. This action would not convert land use to nonagricultural use andtherefore 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 orcultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, orecologically critical areas that may be in close proximity to corn production sites. 

### 4. The degree to which the effects on the quality of the human environment are likely to be highly controversial. The effects onthe quality ofthehuman environment from a determination of nonregulated status ofMON 87460 are not highly controversial. Althoughthere is some opposition to a determination ofnonregulated status ofMON 87460, this action is not highly controversial in terms ofsize, nature oreffect onthe natural orphysical environment. As discussed in Chapter4 ofthe EA, a determination ofnonregulated
status ofMON 87460 is notexpectedto directly cause an increase in agricultural acreage devoted to comproduction, or those com acres devoted to GEcomcultivation. 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 onthe market. MON 87460 is not expected to directly cause an increase in agricultural acreage devotedto comproductionbeyond projected USDA-ERS increases. A determination ofnonregulated status ofMON 87460 will notresult in changes in the currentpractices ofcrop rotation, tillage, and herbicide and pesticide use. MON 87460 exhibits similar agronomic and growth characteristics to conventional corn, with the exception ofreduced grain yield loss under water-limiting conditions. Physiological

12evidence and recorded measures ofmoisture 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 orbiodiversity is no different than that ofother GE ornon-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 ofthese public comments expressed a general opposition to genetically modified organisms (GMOs) orGE crops and the domestic regulatory process surrounding GE plants; perceived negative effects on public and animal health, biodiversity, and the environment; and a lack ofconsideration regarding organic production systems and the public right to choose non-GE containing food products. The majority ofthese public comments did not explain oridentify elements in the MON87460 com PPRA orEA 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 scientificjournals. 

### 5. The degree to which thepossible effects on the human environmentare highly uncertain

or involve unique orunknown risks. Based on the analysis documented in the EA the possible effects onthe human environment are well understood. The effects ofthe proposed activities are not highly uncertain and do not involve unique or unknown risks onthe natural orphysical environment. As discussed in Chapter4 ofthe EA, a determination ofnonregulated
status ofMON 87460 is notexpected to directly cause an increase in agricultural acreage devoted to comproduction, orthose com acres devoted to GE comcultivation. 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 ofGE and non-GE com varieties on the market. MON 87460 is not expectedto directly cause an increase in agricultural acreage devoted to comproductionbeyond projected USDA-ERS increases. A determination ofnonregulated status ofMON 87460 will not result in changes in the current practices ofcrop rotation, tillage, and herbicide and pesticide use. MON 87460 exhibits similar agronomic and growth characteristics to conventional com, withthe exception ofreduced grain yield loss under water-limiting conditions. Physiological evidence and recorded measures ofmoisture 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 ofother GE or non-GE comproduced in conventional agriculture in the U.S. As described in Chapters 2 and 4 ofthe EA, well established management practices, production controls, and production practices (GE, conventional, and organic)

are currently being used in comproduction 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 managementpractices 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 ofcomwere planted and approximately 13.1 billion bushels ofcom were harvested in the U.S. with 86 percentof

13all corn planted in 2010 representing a GE variety (USDA-ERS, 2010; USDA-ERS, 2010a). GE corn varieties represent a progressively increasing proportion oftotal U.S.

cornplanted, ranging from a low of25% in 2000 to 86% in 20I 0 (USDA-ERS, 20I0). Based upon historic trends, conventional production practices that use GE varieties will likely continueto dominate in terms ofacreage with or without a determination of nonregulated status ofMON 87460. Given the extensive experiencethatAPHIS, stakeholders, and growers have in dealing with the use ofGE com products, the possible effects to the human environment from the release ofa an additional GE com product are already well known and understood. Therefore the impacts are nothighly uncertain, and do not involve unique orunknown risks. 

### 6. The degree to which the action may establish aprecedent for future actions with significant effects or represents a decision inprinciple abouta 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. Similarto pastregulatory requests reviewed and approved by APHIS, a determination ofnonregulated status will be based upon an independent determination on whether an organism is unlikely to pose aplant pestrisk pursuant to the regulatory requirements of7 CFRpart 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes this independentreview to determine ifthe regulated article poses aplantpestrisk. Under the authority ofthe plantpestprovisions ofthe PlantProtection Act and 7 CFRPart 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 ofthe regulated status ofGE organisms, including GE plants such as MON 87460. When a petition for nonregulated
status is submitted, APHIS must make a determination ifthe GE organism is unlikely to pose aplantpestrisk. IfAPHIS determines based on its PlantPest Risk Assessmentthat the genetically engineered organism is unlikely to pose a plantpest risk, the genetically engineered organism is no longer subjectto the plantpest provisions ofthe Plant Protection Act and 7 CFRpart 340. APHIS regulations at 7 CFRpart 340, which were promulgatedpursuant to authority granted by the Plant ProtectionAct, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is considered a regulated article ifthe donor organism,
, recipient organism, vector, orvector agent used in engineering the organism belongs to

one ofthe taxa listed in the regulation (7 CFR 340.2) and is also considered aplantpest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism may be aplantpest orAPHIS does not have information to determine if the GE organism is unlikely to pose aplantpest risk. A person may petition the agency that a particular regulated article is unlikely to pose a plantpestrisk, and, therefore, is no longerregulated under the plantpestprovisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. The petitioner is required to provide information under § 340.6( c)(4) related to plantpest risk that the agency may use to determine whetherthe regulated article is unlikely to present a greaterplantpestrisk than the unmodified organism. A GE organism is no longer subjectto the regulatory requirements of7 CFR part 340 orthe plant pest provisions ofthe PlantProtection Actwhen APHIS determines that it is unlikely topose a plantpest risk.

14

### 7. Whether the action is related to otheractions with individually insignificant but cumulativelysignificant impacts. No significantcumulative 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 ofthe EA, a cumulative effects analysis is included for each environmental issue analyzed in the EA. In the event ofa determination ofnonregulated 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 of7 CFRpart 340 or the plant pestprovisions ofthe 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 ofstacked varieties that could be created using both GE corn varieties that have previously been determined to no longer be subject to the regulatory requirements of7 CFRpart 340 orthe plant pest provisions ofthe Plant Protection Act and also non-GE corn varieties is hypothetical and purely speculative. In the event ofa determination ofnonregulated status ofMON 87460, APHIS has not identified any significant impact on the environment which may result from the incremental impact ofa determination ofnonregulated status ofMON 87460when added
to otherpast, present, and reasonably foreseeable future actions. 

### 8. The degree to which the action mayadversely affectdistricts, sites, highways, structures,

orobjects listed in oreligible for listing in the National Registerof Historic Places or may cause loss ordestruction of significantscientific, cultural, orhistorical resources

.. A determination ofnonregulated 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 atthe 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, orobjects listed in oreligible for listing in the National Register ofHistoric Places, nor would it likely cause any loss ordestruction of significant scientific, cultural, orhistorical resources. This action is limited to a determination ofnonregulated status ofMON 87460. Standard agricultural practices for land preparation, planting, irrigation, and harvesting ofplants would be used on these agricultural lands including the use ofEPA registered pesticides. Applicant's adherence
toEPA label use restrictions for all pesticides will mitigate impacts to the human environment. A determination ofnonregulated status ofMON 87460 is not an undertaking thatmay directly or indirectly cause alteration in the characteroruse of historic properties protected underthe National Historic Preservation Act. In general,

common agricultural activities conducted underthis 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 oruse ofhistoric properties. Forexample, there is potential for audible effects on the use and enjoyment ofa historic property when

common agricultural practices, such as the operation oftractors and other mechanical equipment, are conducted close to such sites. A built-in mitigating factor for this issue is

15that virtually all ofthe methods involved would only have temporary effects on the audible nature ofa 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 mayadverselyaffectan endangeredor threatened species

or its habitat that has been determined to be critical under the EndangeredSpeciesAct 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 ofthe Endangered Species Act. Afterreviewing possible effects ofa determination ofnonregulated status ofMON 87460, APHIS has concludedthat 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 affectdesignated critical habitat or habitat proposed for designation. 

### 10. Whether the action threatens a violation ofF ederal, State, or local law orrequirements imposed for theprotection of the 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 plantpestrisk, a determination ofnonregulated status ofMON 87460 is a response that is consistentwith the plant pestprovisions ofthe PPA, the regulations codified in 7 CFRpart 340, and the biotechnology regulatory policies in the Coordinated Framework. MON 87460 does not contain a biotechnology-derived PIPnor is it a biological control organism; thus, EPA does not regulate MON 87460. MON 87460 is within the scope ofthe FDApolicy
statement concerningregulation ofproducts derived from newplant 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 offood and feed derived from MON 87460
tothe FDA on December 19,2008. Based on the information the Monsanto Company submitted, and as ofDecember2010 (BNF No. 000116), FDA hasno further questions regarding MON 87460 droughttolerant corn (FDA, 2010). There are no other Federal, state, or local permitsthatare needed priorto the implementation ofthis action.

NEPA Decision and Rationale I have carefully reviewed the EA prepared for this NEPA determination andthe input from the public involvement process. I believe that the issues identified in the EA are best addressed by selecting Alternative 2 (Determination thatMON 87460 is No Longer a Regulated Article). This alternative meets APHIS' purpose and need to allow the safe development and use ofgenetically engineered organisms consistentwiththe plantpest provisions ofthe PlantProtection Act.

As stated in the CEQ regulations, "the agency's preferred alternative isthe alternative whichthe agency believes would fulfill its statutory mission and responsibilities, giving considerationto economic, environmental, technical and otherfactors." The preferred alternative has been

16selected for implementation based on consideration ofa number ofenvironmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) it allows APHIS to fulfill its statutory mission to protectAmerica'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 plantpest provisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnology regulatory policies in the Coordinated Framework. Forthe reasons stated above, I have determined that a determination of nonregulated status ofMON 87460 will not have any significantenvironmental effects.

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

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 BreedingReviews (Vol. 25): John Wiley and Sons, Inc

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

FDA. (2010). List ofCompleted 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). PlantPest Risk Assessment for MON 87460 Corn. (Biotechnology Regulatory Service). Riverdale, MD: APHIS

- Animal and Plant Health Inspection Service.

17USDA-ERS. (2010). Adoption ofGenetically Engineered Crops in the U.S.: Corn Varieties Retrieved Aug. 11 2010, from http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTablel.htm

USDA-ERS. (201 Oa). Agricultural Projections to 2019.

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

USDA. (2009). 2007 Census of Agriculture: UnitedStates Summary andStateData.

Yu and Babcock, B. (2010). Are U.S. Corn and Soybeans Becoming more Drought T01erant? Staff GeneralResearchPapers: Iowa State University.

18

### Finding ofNo SignificantImpact Response to Comments Petition 09-055-01p

On May 11, 2011, APHIS published a notice in the Federal Register (76 FR27303-27304, Docket no. APHIS-2011-0023) announcing the availability ofthe 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 commentperiod ending July 11, 2011; however, APHIS extended the public comment period for an additional 30 days (76 FR44892-44893, docket numberAPHIS-2011-0023). Comments were required to be received on orbefore 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) opposedthe development and use ofgenetically engineered foods and/or MON87460 corn, while 21
comments supported a determination ofnonregulated status ofMON87460 corn. Public
comments included individual submissions, form letters, and various electronic media encompassing both the peer-reviewed and non-peer-reviewed literature.

Twenty-onepublic 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 salientpoints regarding the potential benefits ofMON 87460 corn, including: 1) a capacity to alleviate the risk ofreduced 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 ofanothertool for American corn growers to meet an increasing global demand for comgrain.

Those 229 public comments received opposing a determination ofnonregulated status of MON87460 comwere submitted by individuals and Non-Government Organizations (NGO). Of these NGOs, three submitted electronic attachments thatconsisted eitherof: 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 ofcomments (22,500). Many ofthesepublic
comments expressed a general oppositionto genetically modified organisms (GMOs) or GE crops andthe domestic regulatory process surrounding GE plants; perceived negative effects on public and animal health, biodiversity, and the environment; and a lack ofconsideration 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 comPPRA orEA 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 ofpublic comments and form letter submissions. These were organized into categories and addressed below.

19Public comments andResponses

Comment 

### 1: Several commenters expressed a general disapproval ofGE plants for noncited reasons related to health and the environment; additionally, severalcomments voiced

concern that an EnvironmentalAssessment (EA) was insufficientfor MON87460 corn and that an EnvironmentalImpact Statement(EIS) should bepreparedto inform any decision regarding a determination ofnonregulated status ofMON87460 corn. Concernswere also raised in response to a perceived APHIS reliance on Monsanto datathroughoutthe MON87460 EA. Several commentersvoiced supportfor 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 1ofthe EA, the basic charge ofAPHIS is to protectAmerican 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, orthe use ofgenetically engineered (GE) varieties) can provide benefits to the environment, consumers, and farm income.

Since 1986, the United States governmenthas 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 ofthe EA). As described in Chapter 1.2 ofthe EA, APHIS regulates the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products under the authority ofthe plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340. A GE organism is no longer subject
to the plant pestprovisions ofthe Plant Protection Act orto the regulatory requirements of7 CFRpart 340 when APHIS determines that it is unlikely to pose a plantpest 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 ofsignificant impacts as presented in the FONSI, an EIS for a determination ofnonregulated status of MON87460 com is not necessary.

APHIS relied on a variety ofsources to support its analysis ofthe potential impacts ofa determination ofnonreguIated 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 ofsources in addition to the MON87460 petition. A complete list ofreferences used to support development ofthe 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 contradictthe national policy as described in the Coordinated Framework for the Regulation ofBiotechnology (51 FR 23302,57FR22984), which states that the mere fact ofusing genetically engineering to modify an organism does not

20mean that the organism necessarily poses a greater risk. Rather, the regulatory approach focuses

on the characteristics ofthe organism or product, and how the organism or product is to be used.

References USDA-APHIS (2010) Plant Pest RiskAssessment 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 thatAPHIS failed to consider geographic isolation as anAlternative, since the target range ofMON87460 corn is the western dryland GreatPlains region. Additionally, several commenters claimed thatAPHIS generally failed to considerthe benefits oforganic corn orbiodynamicproduction systems

as anAlternativein theEA.

Response 2: The EA was beenprepared in orderto specifically evaluate the potential effects on the quality ofthe human environmentthat may result from a determination ofnonregulated
status ofMON87460 com. APHIS assembled a list ofalternatives that might be considered for MON87460. The agency evaluated these alternatives, in light ofthe agency's authority underthe plant pest provisions ofthe PlantProtection Act, and the regulations at 7 CFRpart 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 ofthe EA, APHIS evaluated two alternatives; (1) no action and (2) determination ofnonregulated status of MON87460 in the environmental consequences section oftheEA (Chapter4). In addition, APHIS rejected several other alternatives. These alternatives are discussed briefly in Chapter 3.3 ofthe 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 concludedthat MON87460 does not pose a plant pest risk, and will not exhibit a greaterplant pest risk in any geographically restricted area. Consequently, a Geographic Restriction Alternative would not be consistent with APHIS' statutory authority under the plant pestprovisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordinated Framework; furthermore, the imposition ofgeographic 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 underthe plant pest provisions ofthe Plant Protection Act.

APHIS did not considerthe general nature oforganic 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 orAPHIS regulatory decision in response to Monsanto'spetition request for MON87460 com. The EA was been prepared in orderto specifically evaluate the potential effects on the quality ofthe human environmentthat may result from a determination of nonregulated status ofMON87460 com. The potential impacts ofAPHIS' regulatory decision with respectto non-OE, organic and specialty com production systems are presented in Chapters 2.1.2 and 4.3 ofthe EA.

21Comment 3: Several commenters suggested that the Cumulative ImpactsAnalysis ofthe MON87460 EAwasinadequate in that the stackingofGE traits was not discussed.

Response 

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

Comment4: Several comments expressed concern regarding the potential rejection of MON87460 corn produced in the L.S. by certain foreign markets that havenot approved MON87460 corn for import.

Response4: Key nations and governmentsthat 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 Chapter2.6.1 and Chapter4.8.2 ofthe EA. As stated in the Monsanto petition (Chapter X.C.1.4) and Chapter4.8.2.2 ofthe EA, the Monsanto Company does not intend to enter MON87460 corn into commercial production within the U.S. until all majorU.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 ofU.S. corn, though some are steadily increasing import ofU.S. corn (e.g., China) (USDA-ERS, 2011). Ofthe many GE varieties ofcorn 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 ofcorn, the approval status in foreign countries should be ofmajor 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 ofevents 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 thatare not approved by othercountries and nations (NCGA, 2011). Monsanto is committed to product stewardship, and for its current line ofGenuity corn products,
notes that "Thisproduct has been approved for import into key exportmarkets with functioning regulatory systems. Any crop or material produced from this product can only be exportedto, or used, processed or sold in countries where all necessary regulatory approvals have been granted

...Growers should talkto their grain handler orproductpurchaser to confirmtheirbuying position for this product" (Monsanto, 201Oa, 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 orderto control the adventitious presence ofnon-approved GEtraits (Monsanto, 2010b). A determination of nonregulated status ofMON87460 corn is unlikely to significantly impactthese mechanisms.

22References Marvier M and AckerRCV. (2005) Can Crop Transgenes Be Kept on a Leash?Frontiers in Ecology andthe 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 TraitProducts Lineup Expanded for 20II. The Monsanto Company. Retrieved November, 2011 from http://monsanto.mediaroom.comI20II-genuitv-com-soybean-product-1ineup 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 ofMON87460 corn is unsupported byfield 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 byten percent under well-watered conditions. Additionally, several comments also claimed that APHIS did not discuss conflicting reports from independent

sources regardingthe poor performanceofMON87460 underwell-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 ofMON87460 is unsubstantiated. As mentioned in Chapter4.3.2.2 ofthe EA, MON87460 is not intended to eliminate orreduce the need for irrigation overthe cultivation period ofcorn; rather, it is intended to provide a buffer against yield loss during periods ofdrought stress. While the yield ofMON87460 under suitable water-limited conditions does notexceed that ofthe reference variety range, yield is generally improved relative to its control variety. Forexample, MON87460 yields were significantly higherthan its respective control in combined-site analysis of2006/2007 Chilean field studies. Under water-limited conditions, both 2007 splitplotand stripplot studies demonstrate that MON87460 possessed higher grain yield than its respective control (7.5 and 35.2 percent greater yield, respectively) (Table Rl). Both ofthese sites, while not statistically significant, demonstrated a general increased yield trend ofMON87460 corn relative to its respective control

com variety underwater-limited conditions and a not a 9 percent decrease.

23

### Table R1. Comparison ofgrainyield between MON87460 corn and its control in Great Plain states.

Design Site
Water-Limited
MON87460 1 Split Plot TX Control I 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 TableF-19 ofthe MON87460 petition. 2 Table VITI-II ofthe MON87460 petition.

::I TableF-18 ofthe MON87460 petition. 4 TableF-14 ofthe MON87460 petition. sTableF-15 ofthe MON87460 petition. 6 Table F20 oftheMON87460 petition.

APHIS also disagrees that MON87460 comyielded 10percent less grain than its respective controls under well-watered conditions in Great Plains states. It should be noted thatthe
commenterdid not describe how the 10 percent value was calculated. In Table Rl, while the 2007-TX splitplot and the 2006-KS andNE 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 ofMON87460 com are near identical (2007-NE RCB study:

- 0.07 percent) orgreater (2007-KS, NE, and TX strip plot study: 3.05 percent)than its respective control in the tested GreatPlains states. Despite the direction ofthese differences, the magnitude ofdifferences 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 GreatPlains states.
Additionally, with respectto the claim thatAPHIS did not review independent sources regarding the performance ofMON87460 com underconditions ofnormal precipitation, APHIS is unable
to find any independent reviews ofMON87460 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 amountsto shifting the yield losses experienced in dry seasons onto the good years. While it is not clearfrom the article whetherthat variety is the same event as MON 87460

...").

24With regard to the claimthat 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 ofnonregulatory
status ofMON87460 corn and other GE crops allows for the creationofcorporatefood monopolies.

Response 6: APHIS acknowledges the comments. Although APHIS recognizes thatnew technologies developed and owned by a private firm have the potential to lead to increased market concentration when introduced in the market, introduction ofnewtechnologies or increased market concentration do not in themselves lead to unfair competition. Faircompetition 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 regardingtheplantpest riskof MON87460 corn,includingthepotential to hybridize with sexually-compatiblerelatives to produce progenyplants with weedy characteristics. Additionally, a specific reference was made to therootlodgingofMON87460 corn in one field trial location and its implication with increased plantweediness.
Response 7: MON 87460 com was produced by transformation ofcomtissue using Agrobacterium tumefaciens to introduce the nptIl(neomycin phosphotransferase II) and cspB (cold shockprotein B) genes (as described in Appendix A ofthe EA). Consequently, MON87460 com was considered a regulated article underAPHIS regulations at 7 CFRpart 340. Part 340 regulates, among otherthings, the introduction oforganisms andproducts altered or produced through genetic engineering which are plantpests orwhich there is reason to believe plant pests. Under 7 CFRpart 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 plantpest risk and is unlikely to be any more invasivethan currently available varieties ofcom (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 onplant-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/diseaseresponses. From six field studiestotaling 31 sites across two years, very few unexpected statistically significant differences were observed in combined

25site analyses with regard to phenotypic characteristics (i.e., 14 plant growth/development characters and five seed germination characters) indicative ofincreased weediness between MON87460 corn and control plants. A statistically significant measurement increase in root lodging was observed in one year (Table VIII-4 ofthe MON87460 petition) and was not observed in otheryears (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, ifit were to occur, would result in increased weediness in the MON87460 PPRA. Cultivated corn (MON87460 included) is sexually compatible with several members ofthe genus Zea (e.g., teosinte), and to a much lesser degree, members ofthe genus Tripsacum. As described in the Chapter4.5.4 ofthe EA, the likelihood ofgene flow between MON87460 and teosinte due to differences in flowering phenology, current and expected geographic separation, and genetically based crossincompatibility systems (Baltazaret 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 ofspecialized 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 ofcorn in the U.S. are considered to be weeds in the U.S. (Holm et aI., 1979). Therefore, even in those instances ofaccidental 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 BaltazarB, de Jesus Sanchez-Gonzalez J, de la Cruz-Larios L, and SchoperJ. (2005) Pollination between Maize and Teosinte: An ImportantDeterminant ofGene Flow in Mexico. TAG Theoretical andApplied Genetics, 110(3), 519-526. Doebley J. (1990a) Molecular Evidence for Gene Flow amongZea Species. BioScience, 40(6), 443-448. Doebley J. (1990b) Molecular Systematic ofZea (Gramineae). Maydica, 35, 143-150. Ellstrand NC, GarnerLC, Hegde S, Guadagnuolo R, and Blancas L. (2007) Spontaneous Hybridization between Maize and Teosinte. Journal of Heredity, 98(2), 183. Galinat W. (1988) The Origin ofCorn. In GF Sprague and JW Dudley (Eds.), Com and Com Improvement (pp. 1-27). Madison, WI: American Society ofAgronomy, Inc., Crop Soil Science Society ofAmerica, Inc., and the Soil Science Society ofAmerica, Inc. Holm L, Pancho J, HerbergerV, and Plucknett DL. (1979) A Geographical Atlas ofWorld 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. SexualPlantReproduction, 18(4), 187­ 194. MangelsdorfPC. (1974) Com:Its Origin. Evolution, andImprovement. Harvard University Press Cambridge, MA.

26Monsanto (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 HallauerAR. (1980) Corn. In WR Fehrand HH Hadley (Eds.), Hybridization of Crop Plants (pp. 302). Madison, WI: American Society ofAgronomy and Crop Science Society ofAmerica. USDA-APHIS (2010) PlantPest Risk Assessment for Mon 87460 Corn. Riverdale, MD: APHIS

- Animal and PlantHealth 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 theplant/insertjunctionofthe

### T-DNA cassette. Additionally,concern was also raised regarding any residualAgrobacterium tumefaciens in MON87460 following transformation.

Response 8: With regard to the 22 nucleotide deletion atthe plant/insetjunction 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 ofT-DNA integration followingAgrobacteriummediated transformation is well a known-phenomena and is only detrimental ifa negative phenotype is produced (Bundock and Hooykaas, 1996). In spite ofthis 22 nucleotide deletion, genetic stability ofthe insertwas not negatively affected; furthermore, agronomic, forage, or grain compositional analysis was not negatively affected, suggesting thatthis 22 nucleotide deletion did notdisrupt an essential gene required by corn (USDA-APHIS, 20I0).

Additionally, APHIS concluded that no residualA. tumefaciens remained in MON87460 corn, as the use ofcarbenicillin (Monsanto, 2010) during the corn callus regeneration process effectively eliminatesA. tumefaciens (Opabode, 2006).

References Bundock P and Hooykaas PJJ. (1996) Integration ofAgrobacterium Tumefaciens T-DNA in the Saccharomyces Cerevisiae Genome by IJIegitimate0 Recombination. Proceedings of the NationalAcademy of Sciences, 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 ofPlants: Emerging Factors That Influence Efficiency. BiotechnologyandMolecularBiologyReviews, 1(1), 12-20. USDA·APHIS (2010) PlantPest Risk Assessment for Mon 87460 Corn. Riverdale, MD: APHIS

- Animal and Plant Health Inspection Service. Retrieved from http://Vo/\vw.aphis.usda.gov/biotechnologv!not reg.h1m

### 1

Comment9: A commentexpressed concernregarding honeybee Colony CollapseDisorder (CCD) and genetically engineered cropslikeMON87460 corn.
Response 9: Honey bees (Apis mellifera), the only bee species commercially maintained in the U.S. function as vital pollinators ofa variety ofagricultural crops. First observed on the eastern

27U.S. coast in the second halfof2006, honey bee Colony Collapse Disorder accounted for a decline ofapproximately 36 percentofthe honey bee population (Johnson, 20I0). In contrastto other previous bee colony losses, CCD can be distinguished by several unusual attributes, including: 1) failure ofadultworker bees to return to the hive, despite the presence ofa 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) thatthe mechanisms ofthe loss still remain unknown. Possible causes ofCCD include pathogens, parasites, environmental stresses, and bee management stresses (e.g., poor nutrition); however, recent evidence suggests thatCCD may represent a syndrome caused by a suite offactors interacting synergisticallyto 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 parasiteNosema 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 betweenN ceranae infection and sublethal exposure to the insecticides fipronil or thiacloprid (Vidau et ai., 20 II). Itis prudentto 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 ofthe EA), demonstrating a lack ofatoxicity and allergenicity for human and animal consumption. MON87460 corn, like all com cuitivars, does notproduce
nectar. Thus, foraging honey bees would only collectcom pollen. Mon87460 expresses both nptIIand cspb 

### in a variety ofplanttissues, pollen included. As discussed in Chapter4.5.1.2 and Chapter4.6.1.2 ofthe EA, both NPTn and CSPB are notexpected to have any negative effect on non-target organisms. The safety ofNPTII has been addressed 

### in multiple publications and has been granted an exemption from the requirement oftolerance for use as a selectable marker in

raw agricultural commodities (40 CFRPart 180.1134) (EFSA, 2004; Fuchs etai., 1993a; Fuchs
etaI., 1993b; Nap et aI., 1992). In regard to CSPB, it is not expected to affectnon-target organisms through toxicity. The donor organism for CSPB, Bacillus subtilis, is not pathogenic, has a history ofsafe use, and its enzyme preparations (containing CSPB) are generally recognized as safe by the Food and DrugAdministration (FDA) (FDA, 1999,2010).

References EFSA. (2004) Use ofAntibiotic Resistance Genes as Marker Genes in Genetically Modified Plants. Scientific Opinion ofthe Panel on Genetically Modified Organisms (Gmo) and the Panel ofBiological Hazards (Biohaz). EFSA Journal(4), 1-18. Carbohydrase and Protease Enzyme Preparations Derived from Bacillus SubtiUs orBacillus Amyloliquefaciens; Affirmation ofGras Status as Direct Food Ingredients, FDA. FDA (2010) List ofCompleted 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 ofMicrobially Expressed

28Neomycin 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. Johnson R (20 I 0) Honey Bee Colony Collapse Disorder. Congressional Research Service. Retrieved April 2011, from http://books.google.com/books'?ici=SxaJTt3KgoEC&lpg=PPI &dq=Honey%20bee%2OcoI onv%20collapse%20disorder&pg=PP

### 1#v=onepage&q&f=false. NapJ-P, BijvoetJ, and Stiekema W. (1992) Biosafety ofKanamycin-Resistant Transgenic Plants. Transgenic Research, 1(6),239-249. USDA (2009) Colony Collapse DisorderProgress Report. CCD Steering Committee. Retrieved March 2011, from http://www.ars.usda.govlis/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 ofHoneybees Previously Infected by Nosema Ceranae. PLoS One, 6(6), e2I550.

Comment 

### 10: A commenter claimed thatAPHIS failed to comply with the Endangered SpeciesAct (ESA) by notconsultingother Federal agencies onimpacts to Threatened and Endangered Species.

Response 

### 10: TheEndangered Species Act (ESA) of 1973, as amended, is one ofthe most farreaching wildlife conservation laws ever enacted by any nation. Congress, on behalfofthe American people, passed the ESA to prevent extinctions facing many species offish, wildlife and plants. Thepurpose ofthe ESA is to conserve endangered and threatened species and the ecosystems on which they depend askey components ofAmerica'sheritage. Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/orthe NMFS, ensure that any action they authorize, fund, orcarry out is not likely tojeopardize the continued existence ofa listed species or result in the destruction or adverse modification ofdesignated critical habitat. Itis the responsibility ofthe Federal agency takingthe action to assess the effects oftheir action and to consult with the USFWS and NMFS ifit is determined thatthe 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 theirobligations and responsibilities under Section 7 ofthe 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 ofnonregulated status ofMON87460 would have no effect on federally listed threatened orendangered species or species proposed for listing, norwould it affect designated critical habitat orhabitatproposed 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.

29Comment 11: Several commenters claimed that a determination ofnonregulated status of MON87460 corn would directlylead to a significantincreasein U.S. corn acreage, negatively impacting enrollmentofland in the Conservation ReserveProgram (CRP). Additionally, a commenterclaimed thatAPHIS failed to look at regional impacts ofthe conversionofCRP land to intensive corn production, citing a study by Brookeet al (2009) examining thePrairiePotholeRegion as an exampleofthis 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, 20IIa, 20IIb). However, APHIS disagrees that a determination ofnonregulated status ofMON87460 corn will directly increase U.S. corn acreage. Additionally, APHIS also disagrees with the contention that

a determination ofnonregulated status ofMON87460 corn will reduce enrollment ofland in the CRP.

Itis well established that market forces and government policies are the two primary factors associated with increased U.S. corn production (Claassen and Tegene, 1999; Plantingaet aI., 200I; Secchi et al., 20II; USDA-ERS, 201Ia). Increased domestic demand for corn ethanol and increased international demand for livestockfeed represent two existing and continuing economic forces stimulating corn production (Secchi etal., 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 conservationprograms (e.g., the decrease ofthe 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), governmentreports (USDA-ERS, 2011a, 20IIb; USDA, 2009a), and even the commenterhimlherself("Recently, government incentives for ethanol production have led to dramatic increases in cornproduction;" "This has led to an increase in both corn demand and prices;" "Highcorn prices

...The primary reason farmers take their land out ofCRP 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 atthe expense ofnovel land conversion (USDA-ERS, 20IIb). Itis also worth noting that these existing factors, directly responsible for recent trends in increased corn production, occurred independently ofthe regulatory status ofMON87460 corn. In order for a determination ofnonregulated status ofMON87460 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 costtypically associated with

corn cultivation, or significantly increase grain yield beyond currently-available and

30commercialized 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 parentvariety under waterlimiting condition, the magnitude ofthe MON87460 phenotype is within the natural range of variation ofcommercial corn hybrids under both water-sufficient/limited conditions, strongly suggesting that cultivation ofMON87460 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 ofincreased corn cultivation or speculate on general trends related to CRP land enrollment; it was written to determine ifa determination ofnonregulated status of MON87460 would significantly impactthe quality ofthe human environment, such as enabling the expansion ofcorn acreage beyond what is already available with current corn varieties. As illustrated above, theprimary factors directing U.S. cornproduction occurred and are occurring independently ofthe regulated status ofMON87460 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 ofnatural 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 ofnonregulated status ofMON87460 is unlikely significantly increase corn acreage or decrease CRP enrollmentbeyond what is already occurring. Chapters 2.1.1, 4.3.1.1, 4.3.1.2, and 4.5.1.2 ofthe EA have been rewritten to better illustrate this relationship between existing trends in corn acreage, external market forces, and governmentpolicies that directly affect agricultural commodities. Furthermore, those chapters ofthe EA have been rewritten to clarify APHIS' analysis that a determination ofnonregulated status ofMON87460 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 ofAPHIS to analyze both regional and national impacts on CRP land conversion following a determination ofnonregulated status of MON87460, and the implicationthatthese impacts would differ significantly on the regional and national scales. Firstly, APHIS disagrees withthe commentercontention 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 ofgrassland into agricultural production (when data was available). Thus, any observed effect is due to those three factors collectively. Forthe commenterto attribute any impact solely to CRP land conversion is erroneous, as the metric consists ofthree factors and not one. Furthermore, the land-use change metric and its effects may be overestimated because it takes into account net corn acreage butdoes not attemptto separate out the effect ofcrop shifting, effectively equating shifts away from soybean/wheat on agricultural land with conversion ofnovel land into agricultural production (Brooke et aI., 2009). This is particularly relevant, as it is known that the majority ofadditional corn acreage comes at the expense ofother crops (USDA-ERS, 2011a, 2011b). Secondly, the commenter assumes that any
31national/regional CRP impact will be determined by the availability ofa 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 governmentpolicy. 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 mirroreach other. Also in Figure Rl, it can be observed that general increases/decreases in CRP acreage on both national and regional scales follow CRP enrollmentchanges dictated by successive Farm Bills (increase in 1990; decrease in 1996; increase in 2002; and decrease in 2008), providing an example ofhow governmentpolicy and not a particularcom variety affects CRP acreage. Additionally, ifthis commenter assumption weretrue, 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 thatthis 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(atrend also observed in Figure 5 ofthe EA). Thesetrends suggestthat increases in com acreage do not come atthe expense ofCRP land, butrather from other crops. This is confirmed by USDA-ERS data, where only 2 percent ofcom-soybean farms converted land from CRP after a period ofincreased corn production, with the rest derived from othercrops (USDA-ERS, 2011a). This latterpoint 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 notplanted only at the expense ofwheat).

Issues ofimpacts onthreatened and endangered species were analyzed by species (in their specific regions ofoccurrence) and no impactwas concluded.

Figure R1. US and Prairie Pothole Region CRP acreage
400 6' 

### g 350 

## 8

.-I 300 -USCRP Pothole CRP 100

90 

## So 

# 8

.-I**~ ~**  III 80 III**~** 250 e!**~** 200
Q. D::**~** 150 70

60**~** III 0 !II Q. D:: U III ::J

0:> 0:> C'l .-l 01 0:> C'l .-l 0 01 C'l .-l .-l 0') 0') .-! N 0') C'l .-! m C'l C'l .-! '<t 0') C'l .-! I.J"'l C'l C'l .-l \D 0') C'l .-! ,.... 01 0') .-l 0:> C'l C'l .-! 01 C'l C'l .-l 0 0 0 N .-l 0 0 N N 0 0 N m 0 0 N '<t 0 0 N I.J"'l 0 0 N \D 0 0 N ,.... 0 0 N 0:> 0 0 N 01 0 0 N 50 15 .c



# ... o Q.

Year

32...... N 

### 8 8
N N N

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

### References Brooke R, Fogel G, GlaserA, 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. AgriculturalandResource EconomicsReview, 28(1),26-35. Donner SD and Kucharik CJ. (2008) Corn-Based Ethanol Production Compromises Goal of ReducingNitrogen Export bythe Mississippi River. Proceedings of theNational Academy of Sciences, 105(11),4513-4518. Plantinga AJ, Alig R, and Cheng Ht (2001) The Supply ofLand for Conservation Uses: Evidence from the Conservation Reserve Program. Resources, Conservation and Recycling, 31(3), 199-215.

33 Figure R2. US and Prairie Pothole Region Corn Acreage

- US Corn

- "'" Pothole Corn
1000 0" 0 0 900 0 0 .-4 800**~** QJ blI 1'0 700
QJ



## ... u 1'0 600 C



## ... u 0 500
VI <.0
,..... 

### rg 0"> :::::I 

## § 

# 8 g 8 8 o 

## 8 N N N N N N Year

Figure R3. US and Prairie Pothole Region WheatAcreage

- US Wheat

- - - Pothole Wheat
1000 0" 0 0 900**o~** 0 .-4**~** 800

QJ blI 1'0 700
QJ



## ... u 1'0



## ... 600

1'0 QJ ..r:: 500**~** VI :::::I Year 300 

# So to o .-4 )( 250 -; blI 1'0**~** U 1'0 C 200 

# 8

QJ "0 ..r:: 

## o Q.

300 -. o 

### 8 250 0 o .-4 )( 200 -; blI 1'0 QJ 150 b 1'0



## ... 1'0 100**~ ~**  QJ "0 ..r:: 

## o Q.Secchi S, Gassman P, Williams J, and Babcock B. (2009) Corn-Based Ethanol Production and Environmental Quality: A Case ofIowa and the Conservation Reserve Program. EnvironmentalManagement, 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 andBioenergy, 35(6),2391-2400. Solomon BD, Barnes JR, and Halvorsen KE. (2007) Grain and Cellulosic Ethanol: History, Economics, and Energy Policy. Biomass andBioenergy, 31(6),416-425. USDA-ERS (2009) Briefing Rooms. Corn: Trade. United States Department ofAgriculture

­ Economic Research Service. Retrieved January, 2011 from bttp://www.ers.lIsda.gov/Briefing/com/trade.htm USDA-ERS (2011a) The Ethanol Decade: An Expansion ofU.S. Com Production, 2000-09. EIB-79. United States Department ofAgriculture, Economic Research Service. Retrieved September, 2011 from http://www.ers.usda.gov/Publications/EJB79/ErB79.pdf USDA-ERS (2011b) 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 JI.pdf USDA-FAS (2011) Conservation Programs. United States Department ofAgriculture

- Farm Service Agency. Retrieved 2011, October from http://www.l·sa,usda,gov/FSA/webapp?area=home&subject=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.govIFSA/webapp?area=home&subject=copr&topic=rns-css USDA-NASS (2011) Quickstats 1.0. United Stated Department ofAgriculture

- National Agricultural Statistics Service. Retrieved October, 2011 from http://www.nass.lIsda.gov/QuickStats/Create Federal AIl.jsp USDA. (2009a).2007 Census ofAgriculture: 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 thatthe MON87460 EA did not sufficiently address the relationshipbetween conservation tillage (thus facilitated by GE crops, like MON87460 corn), carbon sequestration, and global climate change. Additionally, several
commenters also asserted thattheMON87460 EA did not examinetheinfluence of conservation tillage strategies onemission ofnitrous oxide, a potent greenhouse gas (GHG), potentiallyoffsetting 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 ofGHG emissions that may affect global climate change. However, the EA was written in response to the Monsanto Company's petition for determination of

34nonregulated status ofMON87460 corn and not to address the effects ofagriculture or genetically engineered crop production systems on global climate change. It is prudentto mention, however, thatmanagement practices between MON87460 corn and currently available

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

corn with other corn events that have previously been determined to no longer be subjectto the regulatory requirements of7 CFRpart 340 orthe plant pest provisions ofthe Plant Protection Act (as described in Chapter4.1 0 oftheEA) and the almost universal adoption ofgenetically engineered corn production systems in the U.S. Chapter 2.2.4 ofthe 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 offactors, including geographic location, soil structure, moisture availability, and agronomic management practices. Given the variability ofthese parameters, tillage impacts may be beneficial, neutral, or detrimental.

Comment 13: Several commenters claimedthat theEA failed to discuss therelationship between increasedpesticide application (associatedwith conservationtillage) and climate changeifMON87460 corn were granted a determination ofnonregulated status. Response 13: As stated in Chapter4.10 ofthe EA and the MON87460 petition, MON87460 is likely to be stacked with GE traits thathave previously been determined to no longerbe subject
to the regulatory requirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act, such as readily available glyphosate tolerant and Bttraits, and very unlikely to be grown as a standalone cornvariety (Monsanto, 2010). As an example, a corn variety containing MON87460 and glyphosate tolerance may be cultivated in place ofa corn variety containing only glyphosate tolerance. Also, as discussed in Chapters 2.1.1, 4.3.1.1, 4.3.1.2 ofthe 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 replacementproduct for com varieties that already require similarpesticide application strategies and that expectation that MON87460 itselfis unlikely to increase corn acreage.

In regard to climate change, APHIS recognizes and understands that agricultural activities contribute to the release ofGHG emissions that may act as affecters ofglobal climate change. However, the EA was written in response to the Monsanto Company's petition for determination ofnonregulated status ofMON87460 corn and not to address the specific effects ofagriculture

or genetically engineered crop production systems on global climate change. APHIS directs readers to Chapter 2.2.4 ofthe EA for a discussion ofclimate 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).



### 35USDA-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 theMON87460 EA failed to examinethe displacement ofless 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. Itis unlikely that a determination ofnonregulated status ofMON87460 comwould significantly impact current and future com production trends, as described in Chapter4.3 ofthe EA. Historical data collected by United States Department ofAgriculture

- National Agricultural Statics Service (USDA-NASS) shows thatplanted com acreage has generally increased overtime as a result ofincreased production efficiency, improved hybrid com varieties, and a net increase in harvested acreage; consequently, othercrops such as sorghum, cotton, and wheat generally show decreases in planted acreage overthe same time frame (USDA-NASS, 20II). 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 bioenergypolicy 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 comproduction for both the present and future outlooks (USDA-ERS,2011b). An examination ofaggregate (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 ofother crops in both the shortrun (2006-2008) and the long

run (2000-2009) (USDA-ERS, 2011a). Additionally, further examination offarm-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 comproduction resultedprimarily at the expense ofcultivated crop acreage (e.g., soybean, cotton, wheat) and with a smallerproportion coming from uncultivated/fallowed land (30 percent) (USDA-ERS, 2011a). The primary source ofthis uncultivated land/fallowed land, however, was hay and grazing land, as only two percent ofcorn and soybean farms brought Conservation Reserve Program (CRP) land into production in 2007, following the peak in domestic com acreage (USDA-ERS, 201 Ia).

Thus, the current trend ofincreasing com acreage primarily atthe expense ofother crop acreage has been occurring independent ofany regulatory decision on MON87460 com. Consequently, current and future market forces affecting comprice and a variety ofgovernmentpolicies are likely to continue affecting farm-levelland-use decisions. A determination ofnonregulated status ofMON87460 com is unlikely to disrupt this trend, due to the relatively smal1 proportion ofdomestic corn production it is likely to represent and the incidence ofcurrent comproduction trends already occurring without the commercialization ofMON87460.

36References USDA-ERS (201Ia) The Ethanol Decade: An Expansion ofU.S. Corn Production, 2000-09. EIB-79. United States Department ofAgriculture, 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, 20II from http://www.ers.usda.gov/Publications/OCEIII/OCEJII.pdf USDA-NASS. (20 11) Corn, Cotton, Sorghum, Soybean, and Wheat Planted Acreage (1985

­ 2010). Retrieved September, 20II from United States Department ofAgriculture, 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 thefrequency ofanimal and human diseases/pathogens, and cited theletter to Agriculture SecretaryVilsackfrom retired ProfessorDon Huber as supportfor this contention. Response 15: Professor Huber's letter alleges that eitherthe gene to produce glyphosate tolerant crops orthe use ofglyphosate (Roundup) is either a promoter orcofactor that facilitates a pathogen capable ofinfecting soybean, corn, theirproducts, 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 ofGoss' wilt in corn, and sudden death syndrome in soybean (no data to supportthe claims). Where animal abortions were noted, an inference was made that animals consumed a wheatproduct, on which glyphosate may have been used indirectly. While these hypotheses are certainly remarkable, there has been no evidence provided for most ofthese statements. Until Prof. Huberpublishes his methods, results and conclusions, scientists have no basis for evaluatingthese claims.

Comment 16: Several commenters expressed concern that both NPTII and CSPB (thetwo introduced proteinsin MON87460) are not sufficiently examined in theMON87460 EA, citing a lackofobjective orpeer-reviewed evidencewith 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 orallergen (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 Chapter4.6 ofthe the donor organism ofCSPB, B. subtilis, is notpathogenic 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

37are not toxic to animals and thus would notbe expected to be toxicto humans (Hong et ai.,**2008~** Simon M, 2011). A search ofthe published literature by Food Safety AustraliaNewZealand (FSANZ) did not identify anyjournal articles relating to the allergenicity ofany ofthe bacterial cold shock proteins (FSANZ, 2010). Additionally, government regulators from both the U.S. Food and Drug Administration (FDA) and FSANZ have determined thatB. 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 othercommercial corn varieties (FSANZ, 2010).

References Burzio LA, McClain JS, and Silvanovich A. (2008). Bioinformatics Evaluation of the Cspb Protein Utilizing theAd8, Toxin6 andProtein Databases. Monsanto Company. EFSA (2007) Efsa Review ofStatistical Analyses Conducted forthe Assessment ofthe Mon863 90-Day RatFeeding Study. European Food Safety Authority. FDA (1998) Guidance for Industry: Use ofAntibiotic Resistance MarkerGenes in Transgenic Plants. U.S. Food and Drug Administration. Retrieved September, 2011 from http://www.fda.gov/food/guidancecompliancercgulatoryinfonnation/guidancedocuments! Qiotechnolouy/ucm096I35.htm Carbohydrase and Protease Enzyme Preparations Derived from Bacillus Subtilis orBacillus Amyloliquefaciens; Affirmation ofGras Status as Direct Food Ingredients, FDA. FDA (2010) List ofCompleted Consultations on Bioengineered Foods. United States Food and Drug Administration, Centerfor 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, DartE, FuchsRL, 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, LeimgruberR, Finn R, Hershman A, and Berberich S. (1993a) Purification and Characterization ofMicrobially 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, NaylorMW, Leimgruber RM, and Berberich SA. (1993b) Safety AssessmentoftheNeomycin Phosphotransferase Ii (Nptii) Protein. Nature Biotechnology, 11(12), 1543-1547. Graumann P and Marahiel MA. (1994) TheMajor Cold ShockProtein ofBacillus Subtilis Cspb Binds with High Affinity to the Attgg- and Ccaat Sequences in Single Stranded Oligonucleotides. FEBSLetters, 338(2), 157-160. Graumann P, Schroder K, Schmid R, andMarahiel M. (1996) Cold Shock Stress-Induced Proteins in Bacillus Subtilis. J Bacteriol., 178(15),4611-4619. Hong HA, HuangJM, Khaneja R, Hiep LV, Urdaci MC, and Cutting SM. (2008) The Safety of Bacillus Subtilis and Bacillus Indicus as Food Probiotics. Journal of Applied Microbiology, 105(2), 510-520.

38Nap J-P, Bijvoet J, and Stiekema W. (1992) Biosafety ofKanamycin-Resistant Transgenic Plants. Transgenic Research, 1(6),239-249. OGRT (2009) Risk Assessment and Risk Management Plan for Dir 95

- Limited and Controlled Release ofSugar 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 ofHealth and Ageing, Office ofthe Gene Technology Regulator. Simon M C. (2011) Bacillus Probiotics. FoodMicrobiology, 28(2), 214-220. Willimsky G,Bang H, Fischer G, and Marahiel MA. (1992) Characterization ofCspb, 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 transferfrom MON87460 corn, noting specifically that: a) Geneticmaterial inserted into GE soy transfers into the DNA ofbacterialiving inside human intestines; b) Gene transfer between MON87460 and other plants may lead to the generation ofherbicide resistantweeds; and c) That gene flow between corn and teosinte may reduce the genetic diversity ofteosinte, creatingproblems for farmers that use teosinte for breeding improved

corn.
Responses 17: As mentioned in Chapter4.7.2 ofthe EA, the Food and Drug Administration (FDA) has previously concluded thatthe likelihood ofhorizontal gene transfer from plant genomes to microorganisms in the gastrointestinal tract ofhumans, animals, orthe environment is remote (FDA, 1998). In regard to the claim that genetic material transfers from humanconsumed GE soy into the DNA ofhuman gastrointestinal tract bacteria, this appears to be a misrepresentation ofthe results from the peer-reviewedjournal article entitled "Assessing the survival oftransgenic 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 ofthe small bowel occurred in three out ofseven human ileostomists (Netherwood et aI., 2004). Ileostomists, however, represent an artificial system where the end ofthe small intestine is separated from the large intestine and connected to collection receptacle; thus, ingested material does not normally proceedthrough 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 oftrue human digestive physiology), the authors concluded thatthe 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 ofherbicide resistant weeds or a reduction in the genetic diversity ofteosinte, the wild progenitor ofdomesticated corn. As discussed in Chapter4.5.4 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

39compatible relatives in the u.s. include Tripsacum dactyloides, Tripsacumfloridanum, and teosinte. As discussed in Chapter4.5.2 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 toleranttraits events that have previously been determined to no longer be subjectto the regulatory requirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act, it is unlikely that gene flow will between corn and sexually compatible relatives will lead to the formation ofherbicide resistant weeds. Also, as discussed in Chapter 4.5.2 and Chapter 4.5.4 ofthe 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 ofgenetic material from MON87460to teosinte, it is also unlikely that MON87460 will erodethe 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.govffood/guidancecompIianceregulatorvinformation/guidancedocuments/ biotechnologv/ucm096135.htm GalinatW. (1988) The Origin ofCorn. In GF Sprague and JW Dudley (Eds.), Corn and Corn Improvement (pp. 1-27). Madison, WI: American Society ofAgronomy, Inc., Crop Soil Science Society ofAmerica, Inc., and the Soil Science Society ofAmerica, Inc. MangelsdorfPC. (1974) Corn: Its Origin, Evolution, andImprovement. 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 ofTransgenic Plant DNA in the Human Gastrointestinal Tract.NatureBiotechnology, 22(2),204-209.



### Comment 18: Several commenters asserted that genetically engineered (GE) commodities and respective agriculturalpractices havebeen proven to have adverse effects on human andlivestock health, including generalized statements suggesting thatGE plants are associated with increasedorgan failure, inflammatorybowel disease, reduced fecundity/fertility, asthma,lungdamage, digestiveproblems, celiac'sdisease, obesity, Morgellon's Disease, autoimmune disorders, autism, and increased endocrine system damage. One commentersuggested thatthe increased prevalenceofGE crops is responsible for the increaseofmany serious diseases in the U.S. Furthermore, one comment alludedto studiesbyDr. IrinaErmakova and a separate studyfrom theBaylor college ofmedicine as evidence thatGE crops were detrimental to human health; additionally, another commentercited a study undertakenbyVendomois etal (2009) in hamsters and rats (2009) as evidence that GE plants contribute to birth defects, high informant mortality rates, and sterilityin 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 ofall food and feed derived from GE plants. No U.S. agency has made an assertion linking GE crops to the presence or increased prevalence ofany disease. Furthermore, following a report from the European Commission (2011) examining the risk ofGE crops, it was stated that "The main conclusion to be drawn from the efforts ofmore than 130 research projects, covering a period ofmore than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are notperse more risky than e.g. conventional plant breeding technologies".

Following a consultation between FDA andthe Monsanto Company, FDA determined that MON87460 com is not materially different from currently-available com varieties, thus concluding that MON87460 does notpose any increased risk with regard to food and feed safety relative to currently-available com varieties (FDA, 2010). Additionally, description ofin silico analysis ofthe two inserted, fully functional, genetic elements (NPTn and CSPB) in Chapter 4.6.1.2 ofthe EA state that neitherNPTII nor CSPB share any amino acid sequence similarities with known allergens, gliadins, glutenins, orproteintoxins 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 subjectto the regulatory requirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act; additionally, the general safety ofNPTII has been described by both the EPA (through the granting ofan 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 percentofidentity with CSPspresent 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 ofan enzyme preparationthat 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 comdescribed by the Monsanto Company Petition (Monsanto, 20I 0) demonstrated that neitherNPTII or CSBP expression oractivity results in any meaningful differences for grain and forage compositions either for major nutrients or secondary metabolites. Collectively, these data strongly suggestthatthe no meaningful changes, aside from the reduced yield loss phenotype under water-limited conditions, are derived from the transformation event itself.

MON87460 comdoes notcontain 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 thatMON87460 may be conventionally crossed with comvarieties containing GE traits that have previously been determined to no longer be subjecttothe regulatory requirements of7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act. Thus, progeny of MON 87460 com may potentially contain a stack oftraits, including drought tolerance, insect resistance, orherbicide tolerance. Itis importantto note thatany trait foreseeably stacked with MON87460 that have previously been determined to no longerbe subjectto the regulatory requirements of7 CFRpart 340 orthe plantpestprovisions ofthe PlantProtection Act, will

41represent a trait that has been previously shown to neither pose a plantpest risk nor present a significant impact on the human health.

The majority ofhealth effects claims were not substantiated without any references from the peer-reviewed literature. Thus, APHIS finds it difficultto address these claims directly; in lieu ofprovided references, APHIS directs commenters to the sections ofthe EA mentioned above and the preceding paragraphs discussing the health and safety of MON87460 corn and its introduced proteins. In regardto 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 ofErmakova's study that make it very difficultto conclude any relationship between GE soy and rat health (Chassy etaI., 2007). Additionally, in the study alluded to by the Baylor College ofMedicine, the commenters' claim is without much warrant, as the original authors ofthe paper make no mention ofGE com in thejournal article (Markaverich et aI., 2001).

Inthe 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 AustraliaNewZealand (FSANZ), and the European Food Safety Authority (EFSA) S(EFSA, 2007; FSANZ, 2009; HCB, 2009). The three scientific groups orregulatory agencies agreed that the conclusions presented by Vendomois et at. (2009) rely primarily on statistical analysis and fail to interpretthese differences within a biological ortoxicological
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), thatno new evidence was provided aboutthe general safety ofthese GE plants, and thatthere was no reason to reconsiderthe 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 ofStatistical Analyses Conducted for the Assessment ofthe Mon863 90-Day Rat Feeding Study. European Food Safety Authority. FDA (2010) ListofCompleted Consultations on Bioengineered Foods. United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland. United States Food and DrugAdministration. Retrieved January 2011 from http://www.fda.gov/Food/Biotechnology/Submissions/default.htm FSANZ (2009) Fsanz Response to a Comparison ofthe Effects ofThree Gm Corn Varieties on Mammalian Health. Food Standards Australia and NewZealand. Retrieved September, 2011 from

42

### http:// www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets2009Ifsanzres ponsetoseraI4647.cfm. HCB (2009) Opinion Relating to the Deposition of 15 December 2009 by the Member of Parliment, Froncois Grosdidier, as to the Conclusions ofthe Study Entitled "a Comparison ofthe Effects ofThree 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 ofBiotechnologies. 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. EnvironmentalHealth Perspectives, 110(2), 169-177. Marshall A. (2007) Gm Soybeans and Health Safety - a Controversy Reexamined.NatBiotech, 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 ofEu-Funded Gmo Research. Brussels, Belgium: European CommissionDirectorate General for Research and Innovation Biotechnologies, Agriculture, Food.

Comment 19: Several commenters expressed concern regarding a studybyAris and Leblanc (2011) describingthe detection oftheCry1ab proteinin maternalblood serum (non-pregnant and pregnantwomen) and fetal blood serum (human fetuses). Several
commenters also raised concernwith regard to a studyby Benachour and Seralini (2009) entitled "Glyphosateformulations induce apoptosis and necrosis in human umbilical, embryonic, and placental cells." Additionally, several commenters generally stated that

morelong-termhuman studies were needed for GE crops, includingMON87460.

Responses 19: In the study by Aris and Leblanc (2011), the Crylabprotein (a common insecticidal protein introduced into GE crops, such as com) was detected in 93 percent of maternal blood, 80 percent offetal blood, and 69 percent ofblood from non-pregnant women. The subjects ofthis study all resided in Sherbrooke, an urban area ofEastern 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 ofthe EA.

While Aris and Leblanc (2011) detected the Crylabprotein in the majority ofblood samples tested, the authors did not make any effortto detennine the origin ofthe Crylabprotein, only assuming thatthe source ofCry1 ab must be through the consumption ofGE crops, "given the widespread use ofGM [GE] foods in the local daily diet (soybeans, com, potatoes

...), it is conceivablethatthe majority ofthe population is exposed through their daily diet." However, the authors neglectto mention thatBacillus 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, naturalIyoccurringB. thuringiensis has been detected in fresh fruits and vegetables (Frederiksen et aI.,

432006); milk, ice cream, and green-tea samples (Zbou etaI., 2008); and human nasal samples following aerial sprays to control gypsy moth populations (Valadares de Amorim etai., 2001).

Additionally, Aris and Leblanc (2011) made no effort to eliminate the possibility ofdetecting 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-CrylabllAcprotein is reported to be 1ng/ml (Paul et aI., 2008); however, Aris and Leblanc detected the Crylabprotein
ataveraged levels ofapproximately 0.18 ng/ml in the blood serum ofpregnant women, 0.12 nglml in the blood serum ofnon-pregnant women, and 0.05 ng/ml in the blood serum ofhuman fetuses. Tbe 1ng/ml detection limit oftbe ELISA kit and the levels detected in the study is problematic, as the detection limit ofa kit is generally regarded as the lowest possible for which

a user may reliably detect a compound. Unfortunately, no additional Crylabprotein detection method was cited in the Aris and Leblanc (2011) study to corroborate and verify thatthese very low detection levels did notconsist offalse 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 CryIab from planttissues (Agdia, 2011; FSANZ, 2011).

APHIS also disagrees with the implication that Btproteins (Cry family proteins) are inherently dangerousto human health. APHIS directs commenters to previousEAs (USDA-APHIS, 2011) thathave examined the risk ofhuman exposure to Btproteins and determined thatBtproteins 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 ofa living organism. Such studies are useful for screening and prioritization purposes (e.g., designing in vivo studies), but they have the major limitation ofrequiring extrapolation ofthe in vitro resultto 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 ofoverall 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 ofwhich affect the dose and form ofthe chemical thatultimately comes in contact with the cell. An affected cell in turn is then subject to possible repair and otherprotective 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 whatchemical 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 ofchemicals compared to whatthe cells would be exposed to after oral, inhalation, ordermal uptake, metabolism, etc.

In summary, APHIS believes thattbe study ofAds and Leblanc (2011) possesses several shortcomingsthat bring its conclusions aboutthe detection ofthe Crylabprotein into doubt. These include issues surroundingthe source ofthe Crylab detected, problems with the assay method used to detectthe Crylabprotein, and the implication that Crylabposes any significant risk to human health. Additionally, APHIS also believes tbatthe limitations ofin vitro glyphosate


### 44toxicity studies cannot be overlooked, and that it should be taken in context ofin vivo studies that have already been performed that suggests a relatively low overall toxicity ofthe 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 ofthe 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 ofBt-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 ofQuebec, Canada. Reproductive Toxicology, 31(4),528-533. Aroian R (20II)Bacillus Thuringiensis

- Organic Farming. University ofCalifornia San Diego. Retrieved October, 20II from http://www.bt.ucsd.edlj/organic farming.html BenachourNand Seralini G. (2009) Glyphosate Formulations Induce Apoptosis andNecrosis in Human Umbilical, Embryonic, and Placental Cells. ChemicalResearch in Toxicology, 22(1),97-105. EPA (2005) Bacillus Thuringiensis Cry3bbl Protein and the Genetic Material Necessary for Its Production (VectorZmir13l) 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 ofNatural Bacillus Thuringiensis Contaminants and Residues ofBacillus 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 ofCrylab Toxin in Bovine Blood Plasma ofCows Fed Bt-Maize (Mon810). Analytica ChimicaActa, 607(1), 106-113. USDA-APHIS (2011) Petitions for Nonregulated Status Granted orPendingby Aphis. United States Department ofAgriculture

- 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-LikeBacteriafrom Environmental and Human Samples after Aerial Spraying ofVictoria, British Columbia, Canada, with Foray 48b. Appl. Environ. Microbiol

.. 67(3), 1035-1043.

45Williams GM, Kroes R, and Munro IC. (2000) Safety Evaluation and Risk Assessment ofthe Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans. Regulatory Toxicology andPharmacology. 31(2), 117-165. Zhou G, Yan J, Dasheng Z, Zhou X, and Yuan Z. (2008) The Residual Occurrences ofBacillus Thuringiensis Biopesticides in Food and Beverages. InternationalJournal of Food Microbiology, 127(1-2), 68-72.

Comment 20: Several comments suggested thatAPHIS failed to adequately analyze the impact ofa determination ofnonregulated status ofMON87460 on thepublic's rightto choose non·GE foods, citing a 2010 NationalPublic Radio (NPR) poll indicating that "an overwhelming number ofAmericans arewary ofGE crop production intheU.S." Additionally, several comments endorsed the labeling ofGE foods orfoods containing GE ingredients,citing a "recentopinion poll thatupto 90 percentofAmericans support the labeling ofGE ingredients" and a pollreleased byABC 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 ofagriculture thrive so that food can remain abundant, affordable, and safe" and thereby promoting an individual's choice topurchase or grow food produced by either conventional, GE, or organic methods. To fulfill its commitmentto NEPA, APHIS has conducted an environmental assessment analyzing the potential impacts ofMON87460 com on all forms ofagriculture. Based on the analysis provided in Chapter4.3,4.5 and 4.8 ofthe EA, APHIS concluded that there is no evidence for significantenvironmental impact on conventional

ororganic agriculture.

However, APHIS disagrees with the conclusionthat an overwhelming number ofAmericans are wary ofGEcrop production in the U.S., based on the cited and misrepresented 2010 NPRpoll. Firstly, while the word "wary" is used in reference to GE salmon in the NPRarticle describing thispoll, "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 ofGE foods, while 21 percent believedthe GE foods were safe (NPR, 2010). Thirdly, a majority (60%) ofthosepolled indicatedthatthey were willing to eat GE vegetables, fruits, and grains, thus dispelling any notion that an overwhelming proportion ofthe popUlation is wary about U.S. GE crop production (NPR, 2010). Whatthis 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, apoll conducted by ABC news also supports this number (ABC News, 2003). While these poB numbers supports another cited poll that states "recentopinionpolls indicate that up to 90 percent ofAmericans support labeling ofGE ingredients," this does not indicate that labeling is entirely related to a desire to avoid GEfoods. Examining the study in further detail, the conclusion drawn by the writers ofthe report state that: "Though itappears 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 aboutthe foods they eat." In order

46to testthis, 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 indicatedthat the information rated as most important to put on a label was "whetherpesticides were used in the process ofgrowing the food." Next in importance was information concerning "whetherthe 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 ofadditional information on food labels and as concluded by the writers, "the support ofsuch 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 plantpest provisions in the Plant Protection Act of2000 (PPA), as amended (7 USC § 7701 et seq.) to ensure that they do not pose a plant pest risk to the environment. The PPA does not grantAPHIS authority to label foods. As described in the EA, the Coordinated Frameworkfor the Regulation of Biotechnology indicates that three Federal agencies, APHIS, FDA and EPA, are responsible for regulating biotechnology in the US. FDAregulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic Act. The FDA policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, waspublished in the FederalRegisteron 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 orotherregulatory issues (e.g., labeling) are resolved priorto commercial distribution ofbioengineered 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 PressDemocrat. 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.comlMediaJMediaManager/RutgersGMFoodStudv

. pdf Hensley S (2010) Americans Are Way ofGenetically Engineered Foods. National Public Radio. Retrieved September, 2011 from http://\vww.npr.org/blogs/health/2011106/071131270519/americans-are-warv-aboutgenetically-engineered-foods NPR (2010)National Survey ofHealthcare 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 ofa proposedisolation distancebyAPHIS, and thepossibility ofseed mixturebetween MON87460 (orgenetically engineered [GE1 corn in general) and organic cornwould result inthe adventitious presenceofGE material in organic corn. These comments referenced StarLink corn and LibertyLinkRice as evidence to supporttheir claims that mixing of GE andorganic seed is inevitable. Consequently, several commenters suggested thatthe

47EA failed to examine howthe adventitious presenceofMON87460 corn (or any other variety ofGE corn) may impacttheU.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 canbe marketed and labeled as "organic" (USDA-AMS-NOP, 2011). Organic certification is a process-based certification, not a certification ofthe end product; the certification process specifies and audits the methods and procedures by which the product is produced. Consequently, USDA-certified organic labeling requires thatgrowers develop and submit an organic production plan in orderto outline the steps taken to avoid contactor mixing with the products ofexcluded methods (e.g., non-approved synthetic pesticides or fertilizers). In accordance with NOP regulations, organic operators are required to manage the potential exposure oforganic commodities with other substances not approved for use in organic production systems, whetherfrom the non-organic portion ofa split operation orfrom neighboring farms. The use ofGE products is specifically prohibited in organic production and handling; however, the inadvertentpresence ofGE 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 ofproceduresto maintain seed and commodity integrity within the context ofan individual organic system plan required for NOP certification has proven effective in preventing the presence ofexcluded materials in certified organic products.

Growers have, for decades, been successfully growing crops bearing different traits and often on adjoining fields despite the method by which traits were introduced (conventional breeding or recombinant DNA technology). Growers have always had the choice ofwhat crops to grow, and have had to contend with commingling, admixtures, and other contaminants in their crops (Ronald and Fouche, 2006). Studies ofcoexistence ofmajor GE and non-GE crops in North America and the European Union (EU) have demonstrated that there has been no significant introgression ofGE genes, and that GE and non-GE crops are coexisting with minimal economic effects (Brookes and Barfoot, 2004a; Brookes and Barfoot, 2004b; Gealy etaI., 2007). Ultimately, underNOP regulations, organic producers are obligated to manage their operations
to avoid unintentional contactwith excluded methods. As described in Chapter 2.1.2.2 and Chapter4.3.3 ofthe EA, isolation distances, reproductive isolation (e.g., staggering planting dates orgrowing corn with differential maturity times), and farmer communication can be successfully used to minimize the effects ofpollen-mediated gene flow from MON87460 corn into organic corn. Growers can obtain the Association ofOfficial Seed Certifying Agencies' (AOSCA) reference material which describes the isolation distance requirements for the certification ofcorn seed (AOSCA, 2003, 2009). Additionally, organic growers may also choose to plant borderrows to mitigate the movement ofpollen 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, borderrows, planting dates, maturity dates, cleaning ofequipment, and post-harvest handling have traditionally been able to provide products thatmeet 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 preventthe possibility ofunintended 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 (GreatPlains states) ofMON87460 may encounter, it is clearthat organic corn acreage is increasingly steadily in spite ofconcurrent increases and overwhelming adoption ofGE corn production, suggesting that current methods to limit corn gene flow are sufficient and thatthe large presence ofGE corn has not stopped the cultivation ofcorn by organic methods (Figure Rl). As discussed in Chapter 4.5.2 ofthe 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 ifMON87460 were cultivated.

.

FigureR4. Acreage ofcorn produced by GE ororganicproduction 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 GreatPlains states were unavailable from USDA-ERS {J. Moore, personal communication). Data collected from (USDA-ERS, 20IOa, 201Ob; USDA-NASS, 2011b).

The possible costto organic producers resulting from proximity to GE-based agriculture is dependent upon the acceptable level ofGE material that may be inadvertently present and on consumers' expectations and perceptions. The NOP identifies four levels ofproductcomposition for organic agriculture certification (7 CFR205.301): 1) 100 percent organic; 2) 95 percent or

49more 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). Ifthere is a negative public perception ofthe adventitious presence ofGE material in organically-produced products, profitability ofan organic enterprise may be diminished through the loss ofprice premiums earned by these products. Survey evidence presented in the Brookes and Barfoot (2004a) study showed that the vastmajority (92 percent) of U.S. organic farmers had not incurred any direct additional costs or incurred losses due to GE crops having been grown neartheir crops. According to the report, fourpercent had experienced lost organic sales or downgrading ofproduce as a result ofGE organismpresence and the remaining four percent offarmers 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 ofmeasures 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 compensatedfor the unidentified costs associated with meeting any contractual obligations and NOP standards for corn produced through organic systems. Forexample, 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 ofacres planted to corn and othercrops 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 ofregulated GEplants in confined field tests. Therefore, it is reasonable to assume that coexistence practices can be sufficient to maintain the integrity ofa crop and the purity ofseed, especially ifthere 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 ofpurity, for example, a bag of"pure" seed cornwill cost $100 per bag, whereas one that exceeds the 5% tolerance is worth $2 perbag (Fernandez and Polansky, 2006).

References AOSCA (2003) Aosca: 99%Non-Gmo Corn Grain Program Requirements. American Association ofSeed 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 ofGm Canola on Organic Farming in Australia, Abare Research Report 07.11. Prepared for the Australian Government Department ofAgriculture, 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 BarfootP. (2004b) Coexistence ofGm and Non-Gm Crops: Case Study ofMaize Grown in Spain. Dorchester, Uk: Pg Economics Ltd. Fernandez M and Polansky A. (2006). Presented atPeaceful Coexistence Among Growers of: Genetically Engineered, Conventional, and Organic Crops. Summary ofa MultiStakeholderWorkshop, Boulder, CO.

50Gealy D, Bradford K, Hall L, Hellmich R, Raybould A, Wolt J, and Zilberman D (2007) Implications ofGene Flow in the Scale-up and Commercial Use ofBiotechnologyDerived Crops: Economic and Policy Considerations. Council for Agricultural Science and Technology (CAST). KruegerJE (2007) IfYour Farm Is Organic, Must It Be Gmo-Free?

.Farmers' Legal Action Group, Inc. Retrieved from http://www.f1aginc.org/topics/pubs/alts/Organi csAndGMOs2007.pdf Kuepper G (2002) Organic Field Com Production. National Sustainable Agricultural Information Service. ATTRA. Retrieved from bttp:l/attra.ncat.org/attrapub/PDFlfieldcorn.pdf NCAT (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 ofCalifornia, 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 ofNon-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 ofAgriculture, 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) PlantPest 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.htmI USDA-ERS (2010a) Adoption ofGenetically Engineered Crops in the U.S.: Com Varieties. Retrieved Aug. 11 2010, from http://www.ers.usda.gov/DataiBiotechCrops/ExtentofAdoptionTablel.htm USDA-ERS (20lOb) Organic Production. Retrieved February 2011, from http://www.ers.usda.gov/Data/Organic/ USDA-ERS (2011) Organic Prices. United States Department ofAgriculture, Economic Research Service. Retrieved October, 2011 from http://w\vw.ers.usda.govIdata/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/usdalcurrentiCropValuSu/CropValuSu-02-16-20II.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

### Comment22: Several commenters expressed concern thatthe adventitious presence ofGE traits has deterred farmers from producing corn through organic methods, thus reducing the capacityofthe organicindustryfrom growing due to supplyissues. Asjustificationfor this, one commenter quoted an organic grain handlerexplaining that they areunableto supplyorganiccorn because ofunreliable separation between organic and GE corn production.

Response 22: APHIS supports all forms ofagricultural production, whether it is organic, conventional, or GE production methods. Additionally, as stated in the EA, APHIS acknowledges that there may be a lag between supply and demand oforganic corn. However, assigning the presence ofGE corn as the major oronly factor preventing further organic corn production is notconsistentwith observations aboutthe economic and market successes of organic crops. Even the same commenter suggests GE corn production may prevent organic

corn adoption concedesthat "it is unclear why more U.S. farmers are not growing organic corn." Just as demonstrated for several other organic commodities, such as coffee ornuts, short supplies have been noted, although many ofthese do nothave any commercialized GE varieties (Greene
etaI., 2009).

As stated in Chapter4.3.3.2 ofthe EA, organic corn production continuesto increase in the U.S. despite the presence ofcorn produced through excluded methods. This trend demonstrates the capacity ofcurrent organic system plans to avoid the use ofexcluded methods and the efficacy of these plans to increasingly produce organic agricultural commodities for target markets. Additionally, the same organic grain handler cited by the commenters is also cited as providing otherreasons for the tight supply oforganic agricultural commodities, including: 1) the threeyeartransition requirement for organic production; 2) fewer organic marketing outlets; 3) the need for on-farm storage; 4) the lack ofthird-party contractors for organicpest and nutrient management; 4) heavy and intensive production requirements; 5) fear ofcriticism from neighbors; 6) unknown risks; 7) an absence ofsupporting government infrastructure; 8) and subsidies for ethanol that increase demand for conventional production and supply (Greene etaI., 2009). Furthermore, Brookes and Barfoot (2004) also noted in an examination oftrends in the planting ofGE and organic crops that the growth ofthe crop areaused for GE plants has not impeded the development ofthe organic sector in North America. The U.S. had under a million

acres ofcertified organic farmland when Congress passed the Organic Foods Production Actof 1990. Bythe time USDA implemented national organic standards in 2002, certified organic farmland had doubled, and doubled again between 2002 and 2005 (USDA-ERS, 2010). The U.S. total number ofcertified organic producers in 2000 was 6,592; this number increased to 10,159 in 2007 (USDA-ERS, 2010). Thus, due to the presence ofall these possible preventative factors and the concurrentgrowth ofboth organic and GE com sectors, it is unlikely that a determination ofnonregulated status ofMON87460 will not have any impact onthe 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.

52Greene C, Dimitri C, Lin B-H, McBride W, Oberholter L, and SmithT (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 2011, from http://www.ers.usda.gov/Data/Organic/

Comment23: Several commenters expressed concern that cultivation ofMON87460 corn, either aloneor stacked with other commercially-available GE traits, wouldlead to a general increasepesticide application. Additionally, several commenters also expressed

concern that thepresenceofa GE corn variety stackedwith MON87460 and glyphosatetolerancetraits will lead to an increasein incidents ofglyphosate-resistantweeds.

Responses 23: While it was stated that Chapter4.3.2.2 ofthe EA that cultivation ofMON87460 may result in a shift away from glyphosate use, itwas also stated thatthis shifts is likely to be limited through stacking ofthe 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 ofMON87460 with GEherbicide-tolerant traits is very likely (Monsanto, 2010). The Cumulative Impacts section (Chapter 5) ofthe EA has been rewritten to further clarify this point and address commenter concern thatthe stacking oftraits will lead to an increase in pesticide application. Due to similarmanagement strategies between any stacked hybridprogeny and theirparentvarieties (e.g., hybrid progeny and one ofthe parent varieties will possess herbicide tolerance), overall pesticide application will remain relatively unchanged and is not likely to increase beyondthat which can be expected from projected increases in comcultivation. Otheragricultural inputs, such as fertilizer application, will likely slightly increase as welL

Weedmanagement is an importantpart ofany agricultural system. The commercialization of

com varieties stacked with glyphosate-tolerant andthe MON87460 traits would permitexisting and widely-adopted management strategies to continue. Relying on glyphosate alone as the only weed-removal strategy may influence the number ofweed species thatmay become glyphosateresistant. However, as this same commenterconcedes, "These specific risks are not unique to MON87460" and may be influenced by a number ofother factors involved in the evolution of glyphosate resistance in weeds. A variety ofgenetic, biological/ecological, and operational factors contributeto the evolution ofherbicide resistance in weeds. Genetic factors include the frequency ofgenes in a particularweed species thatpromotes resistance to a particularherbicide, the mechanism ofresistance and the capacity ofgenes to facilitate this resistance, how resistance is inherited, and the fitness ofthe weed in the presence and absence ofthe herbicide (Georghiou and Taylor, 1986; Neve, 2008). Biological/ecological factors include the method ofweed reproduction, seed production capacity, seed bankturnover, and the amount and frequency of gene flow between weed populations (Jasieniuk et ai., 1996; Maxwell and Mortimer, 1994). Collectively, these issues illustrate thatdifferentplant species may present different risks of resistance. Operational factors influencing development ofweedresistance include farm-level management practices such asthe chemistry ofthe applied herbicide and its respective

53mechanism ofaction, and the application rates/frequency ofherbicide application (Georghiou and Taylor, 1986; Jasieniuk et aL, 1996).

Currently, there are no concrete data, information, ormodels that provide a prescriptive determination on the evolution ofherbicide resistance in specific weeds orthe efficacy ofa particular management strategy to preventthe evolution ofresistance to glyphosate. APHIS is
not aware ofany models that simulate the evolution ofweed resistance to glyphosate in herbicide-tolerant agricultural systems. What can be generally observed, however, is the influence a management strategy exerts in the evolution ofherbicide resistance in weeds. With regard corn varieties stacked withMON87460 and glyphosate resistance, it is unlikely that this GE hybrid corn variety would alter any baseline influence ofestablished management strategies that are currently practiced in GE corn cultivation systems. Thus, it is unlikely that any GE corn hybrid variety stackedwithMON87460 would increase the incidence ofglyphosate resistant weeds, as the factors resulting in ofglyphosate resistance in weeds wouldremain unchanged. Chemistry ofthe appliedherbicide (e.g., glyphosate) and the frequency and rate ofapplication would remain unchanged, as any progeny GE corn variety containing both MON87460 and glyphosate-toleranttraits wouldpossess the same glyphosate-toleranttrait as its parent variety, and thus, require similarweed management.

References Georghiou G and Taylor C. (1986) Factors Influencingthe Evolution ofResistancePesticide Resistance: Strategies and TacticsforManagement (pp. 157-169). Washington DC: National Academy Press. Jasieniuk M, Brule-Babel AL, and Morrison IN. (1996) The Evolution and Genetics ofHerbicide Resistance in Weeds. WeedScience, 44(1), 176-193. Maxwell B andMortimerA. (1994) Selection for Herbicide Resistance. In S Powles and 

### J Holtrum (Eds.), HerbicideResistance in Plants: BiologyandBiochemistry (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 Modelingto Understand the Evolution and Managementof Glyphosate Resistance in Weeds.PestManagement Science, 64,392-401. USDA-APHIS (2011) Petitions for Nonregulated Status Granted orPending by Aphis. United States Department ofAgriculture

- Animal and Plant Health Inspection Service. Retrieved September, 2011 from http://www.aphis.lIsda.gov/biotechnology/not reg.html

Comment24: Concern was expressed by commenters thatMON87460 corn would generally harm soil microorganisms and that soil and waterqualitywould sufferif**MO~87460** corn were stacked with commercially-available GE corn varietiesthatpossess insectresistance (Bt proteinproduction) and/orherbicide-tolerance (e.g., glyphosatetolerance) traits.

54Response 24: APHIS disagrees that MON87460 would harm soil organisms. As detailed in Chapter 4.4.2.2 ofthe EA, microbial soil populations may encounter the NPTII and CSPB proteins produced by MON87460 corn through degrading plantmaterial in the field orthe 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 ofGE crops without any adverse effect on the environment. APHIS refers any commenterto the EA and response #16 ofthis FONSI for further discussion about the relative safety ofMON87460 corn and its expressedproteins. Additionally, compositional analysis of MON87460 corn reveals that it is similar to conventional corn, with no meaningful biological differences (USDA-APHIS, 2010), thus suggesting thatthere would not be any differences in availability ofnitrogen orother nutrients following the degradation ofplant material in the field.

As discussed in Chapter 5 ofthe EA, MON87460 will likely be stacked with commerciallyavailable GE corn traits. The two mostcommon GE corn traits include glyphosatetolerance and insect resistance. The glyphosate-tolerantphenotype permits the application ofthe herbicide glyphosate in orderto control weeds. Glyphosate adsorbs strongly to soil, does not generally

move vertically below six inches through the soil, and typically possesses a half-life ofless than 60 days (Giesy etaI., 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
amountofclay ororganic 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 lowerthan levels with potentially adverse effects (Gimsing etaI., 2004; USDA, 2003). While some datahas 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 itselfis 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 Btproteins that confer specific insectresistant phenotypes. Bt proteins are a family ofproteins produced by Bacillus thuringiensis that exhibit specificity for either Lepidopteran orColeopteran pests ofcorn. Soil organisms may be exposed to Btthrough decaying plant material from orthe root system ofBt-expressing plants. Evidence shows that Btproteins have no measurable effect on soil microbial populations, of either bacteria, actinomycetes, fungi, protozoa, algae, ornematodes (Mendelsohn etaI., 2003). APHIS agrees that weed management strategies can impact soil and water quality, such as tillage affecting runoffand soil loss. The majority ofcorn 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 ofthe EA, no direct impact on currentcorn pestmanagementpractices is likely to result from hybrid corn progeny stacked with MON87460 and/or herbicide-tolerant and/or insect-resistanttraits. MON87460 expressing these GE hybrid corn traits would require similar management strategies as the parentvarieties. Stacked corn varieties with MON87460

are intended to be replacementproducts for GE corn varietiespossessing herbicide tolerance and/or insect resistance in its targetrange; thus, no increase or shift in pesticide application is

55expected, nor is any alteration anticipated in tillage. These two factors may influence soil and
waterquality and will remain unchanged from currentpractices ifstacked com varieties with MON87460 were cultivated. Furthermore, compositional analysis ofboth MON87460 and commercially-available GE corn varieties demonstrated thatthey are not dissimilar (USDAAPHIS, 2010, 2011); consequently, any progeny derived from these varieties and MON87460 is unlikely to be compositionally different from its respective parentvarieties and unlikely to significantly impact soil organisms through degradation ofplanttissue 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 insectresistanttraits, 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 managementconditions already in place in conventional corn production systems. Evidence inthe literature demonstrates no toxicity for eitherglyphosate or Bt proteins on soil microorganisms.

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

### 1, Nehring R, Sinha EN, Grube A, and Vialou A. (2009)AssessingRecent Trends in Pesticide Use in Us. Agriculture. Paper presented atthe Meeting ofthe AAEA, Milwaukee, WI. Giesy J, Dobson S, and Solomon K. (2000) Ecotoxicologicai Risk Assessment for Roundup Herbicide. Reviews of Environmental 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.AppliedSoilEcology, 27(3), 233-242. Mendelsohn M, Kough J, Vaituzis Z, and Matthews K. (2003) Are BtCrops Safe?Nature Biotechnology, 21 (9), 1003-1009. Monsanto (2010) Petition for the Determination ofNonregulated Status for Mon 87460. Submittedby 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 ofAgriculture

- Animal and Plant Health Inspection Service. Retrieved September, 2011 from http://www.aphis.usda.gov/biotechnology/notreg.html USDA-FS (2003) Glyphosate

- HumanHealth and Ecological Risk Assessment: Final Report. United States Department ofAgriculture 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 DepartmentofAgriculture.

56