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

Monsanto Improved FattyAcid Profile MON 87705 Soybean

United States DepartmentofAgriculture Animal and PlantHealth Inspection Service Biotechnology Regulatory Services

The United States Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has developedthis decision documentto complywith the requirements ofthe National Environmental PolicyAct (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing regulations and procedures. ThisNEPA decision document, a Finding ofNo Significant Impact (FONSI), sets forth APHIS' NEP A decision and its rationale. Comments from the public involvement process were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementingNEPA 

### (7 CFRpart 

### 372), APHIS has prepared anEnvironmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated

.. ;, status ofa petition request (APHIS Number09-201-01p) byMonsanto for their transgenic soybean, event MON 87705 (hereafter referred to asMON 87705 Soybean), that is genetically enhanced to suppress the endogenous

### F ATB and 

### F AD2 ribonucleic acid (RNA) in the developing soybean seed. This enhancement improves the fatty acid profile to contain lower saturated (palmitic and stearic) fatty acids, lowerpolyunsaturated (linoleic) fatty acid levels, andhigher levels ofmonounsaturated (oleic) fatty acid (Monsanto, 2010). MON 87705 Soybean also expresses CP4 EPSPS protein throughout the plant conferringtolerance to glyphosate, which is the active ingredient in the Roundup® family ofagricultural herbicides. This EA has been prepared in order to specifically evaluate the effects onthe quality ofthehuman environment l that mayresult from a determination ofnonregulated status ofMON 87705 Soybean. TheEA

assesses alternatives to a determination ofnonregulated status ofMON 87705 Soybean 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 productivityand competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural production (conventional, organic, orthe use of genetically engineered (GE) varieties) can providebenefits to the environment, consumers, and farm income.

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

1 ISince 1986, the United States government has regulated genetically engineered (GE) organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) (51 FR 23302,57 FR 22984). The Coordinated Framework, publishedby the Office ofScience and Technology Policy, describes the comprehensive federal regulatorypolicy for ensuring the safety ofbiotechnologyresearch and 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: (1) agencies should define those transgenic organisms subject to review to the extentpermitted bytheir respective statutory authorities; (2) agencies are required to foeus on the eharacteristics and risks ofthe biotechnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight ofG E organisms onlywhen 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 andplants under the plant pestprovisions in the Plant Protection Act of2000, as amended (7 USC § 7701 etseq.) to ensure that they do not pose a plant pest risk to the environment.

The FDA regulates GE organisms under 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, including those that are genetically engineered. To help developers offood and feed derived from GE crops comply with theirobligations under Federal food safety laws, FDA encourages them to participate in a voluntary consultation process. All food and feed derived from GE crops currently on the market in the United States have successfully completed this consultation process. The FDA policy statement concerning regulation ofproducts derived from

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

on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a eonsultation process to ensure that human food and animal feed safety issues orotherregulatory issues (e.g., labeling) are resolved prior to commercial distribution ofbioengineered food.

The EPA regulates plant-incorporated protectants underthe Federal Insecticide, Fungicide, and Rodentieide Act (FIFRA). EPA also sets tolerance limits for residues ofpesticides on and in food and animal feed, or establishes an exemption from the requirement for 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 producedby

an organism through teehniques 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

2Federal Regulations (CFR) part 340, which werepromulgatedpursuant to authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms andproducts. A GE organism is no longer subject to the plantpestprovisions ofthe PlantProtectionAct orto the regulatoryrequirements of7 CFRpart 340 whenAPHIS determines that itis unlikely to pose a plantpest risk. A GE organism is considered a regulated article ifthe donororganism, recipient organism, vector, orvector agentusedin engineering the organism belongs to one ofthe taxa listed in theregulation (7 CFR 340.2) and is also considered

a plantpest. A GE organism is also regulated underPart 340when APHIS has reason to believe that the GE organism maybe a plantpest orAPHIS does not have information to determine if the GE organismis unlikelyto pose a plantpestrisk.

A person maypetition the agencythat a particularregulated article is unlikelyto pose a plant pest risk, and, therefore, is no longerregulatedundertheplantpestprovisions ofthe Plant ProtectionAct orthe regulations at 7 CFR 340. Thepetitioner is required to provide information under § 340.6(c)(4) related to plantpestrisk thatthe agencymayuse to determinewhetherthe regulated article is unlikelyto present a greaterplantpestrisk than the unmodified organism. A GE organism is no longer subjectto the regulatoryrequirements of7 CFRpart 340 ortheplant pestprovisions ofthe PlantProtection Actwhen APHIS determines that it is unlikely to pose a plantpestrisk.



### APHIS' Response to Petition for Nonregulated Status Underthe authority oftheplantpestprovisions ofthe Plant Protection Act and 7 CFRParl340, APHIS has issuedregulations for the safe development anduse ofGE organisms. As required· by7 CFR 340.6, APHIS mustrespond topetitioners who request a determination ofthe regulated status ofGE organisms, including GEplants such as MON 87705 Soybean. When a petition for nonregulated status is submitted, APHIS mustmake a determination ifthe GE organismis unlikelyto pose a plantpestrisk. IfAPHIS determines basedon its Plant Pest Risk Assessment (PPRA) thatthe genetically engineered organism is unlikelyto pose a plantpest risk, the genetically engineered organism is no longer subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340.

Monsanto has submitted a petition (APHIS Number09-201-01p) to APHIS seeking a determination thattheir transgenic soybean, MON 87705 Soybean, is unlikelyto pose a plant pest risk and, therefore, should no longerbe a regulated article underregulations at 7 CFRPart 340.


### Improved FattyAcid Profile Monsanto 87705 Soybean Monsanto has developed a transgenic soybean, MON 87705 Soybean, thatproduces soybean seeds with lower levels ofsaturated (palmitic and stearic) and polyunsaturated (linoleic) fatty acids, and higher levels ofmonounsaturated (oleic) fatty acid than those found in non-modified soybean seeds. MON 87705 Soybean contains DNA segments designed to suppress endogenous delta-12 desaturase (FAD2) and Acyl-ACP thioesterase (FATB) genes which encode for two enzymes in the soybean fatty acid biosynthetic pathway. MON 87705 Soybean also contains the 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) gene encodingthe CP4 EPSPS protein. The cp4 epsps gene is used as a selectable markerto identifytransgenic plants during

3the transformation process. The CP4 EPSPS protein confers tolerance to glyphosate and has been used in manyRoundup Ready® crops (e.g., canola, corn, cotton, soybean, and sugar beet).

The MON 87705 Soybean oil fatty acid profile provides new formulation options for food companies interested in the development oflower saturated fat food products to support heart health. Low saturated fats and high (>70%) oleic acid levels are also key attributes for vegetable oils targeted for biodiesel and industrial uses (Monsanto, 2010). These characteristics are vital to improved cold weatherperformance, improved stability, and reduced nitrous oxide emissions (Graefet aI., 2009; Knothe, 2005). In addition to the altered fatty acid profile, the soybeans were engineered with glyphosate tolerance to provide growers ofthese soybeans with weed control options as well.



### Coordinated Framework Review

FoodandDrugAdministration MON 87705 Soybean falls within the scope ofthe 1992 FDA'spolicy statement concerning regulation ofproducts derived from new plant varieties, including those developed through biotechnology (US-FDA, 1992). In compliance with this policy, Monsanto initiated a consultation with the FDA on the food and feed safety and nutritional assessment summary for MON 87705 Soybean. A copy ofthe completed FDA review is provided in Appendix A ofthe EA.

EnvironmentalProtectionAgency EPA has authority under FIFRA to establish pesticide use restrictions; these use restrictions are presented on pesticide labels which are prepared during the pesticide registration process. The CP4 EPSPS protein expressed in MON 87705 Soybean is similar and functionally identical to endogenous plant EPSPS enzymes and is identical to the CP4 EPSPSs in other Roundup Ready® crops including Roundup Ready® soybean (40-3-2 and MON 89788). Monsanto indicates that there will be no change in the use pattern for glyphosate on this glyphosate tolerant variety and there will be no need to petition EPA for a change in the label for glyphosate (G.Rogan, personal communication, 2011). APHIS used eurrent glyphosate labels as the basis for its evaluation of the potential impacts associated with the use ofand exposure to glyphosate.



### Scope ofthe Environmental Analysis Although a determination ofnonregulated status ofMON 87705 Soybean would allow for new plantings ofMON 87705 Soybean to occur anywhere in the U.S., APHIS limited the environmental analysis to those geographic areas that currently support soybeanproduction. A determination ofnonregulated status ofMON 87705 Soybean is not expected to increase soybean production, or result in an increase in overall GE soybean acreage or cultivation in new regions. In the U.S., soybeans are cultivated in 31 states, with over 77 million acres dedicated to soybean cultivation, projected to increase to nearly 80 million acres by 2020 (USDA-NASS, 201la, 20llb; USDA-OCE, 2011). Table 2-2 in the EA, presents an overview ofthe 2009 and 2010 aereage ofsoybeans planted by state.



### Public Involvement On June 28, 2011, APHIS published a notice in the Federal Register (76 FR 37771-37772, Docket no. APHIS-20 11-0046) announcing the availability ofthe Monsanto petition, and the

4APHIS PPRA and draft EA for a 60-daypublic review and commentperiod. Comments were required to be received on orbefore August 29, 20II. All comments were carefully analyzed to identify new issues, alternatives, orinformation. A total of36 commentresponses were received from various groups and individuals during the commentperiod, with 29 comments providing support ofthe EA'spreferred alternative and 7 comments in opposition. Comment documents maybe viewed at http://www.regulations.gov/#!searchResults:dct=PS;lpp=lO;po=O;s=aphis2011-0046. No new issues, alternatives or substantive new information were identified in any of the comments received byAPHIS. Responses to substantive comments are included as an attachment to this Finding ofNo Significant Impact.


### MajorIssues Addressed in 

### the EA The issues considered in the EA were developed based on APHIS' determination that certain genetically engineered organisms are no longer subjectto the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340, and for this particularEA, the specific petition seeking a determination ofnonregulated status ofMON 87705 Soybean. Issues discussed in the EA were developedbyconsideringpublic concerns as well as issues raised inpublic comments submitted for other environmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well as those issues that have been raised byvarious stakeholders. These issues, including those regarding the agricultural production ofsoybean using various production methods, and the environmental and food/feed safety ofgenetically**engin~ered** plants were addressed to analyze thepotential environmental impacts ofMON 87705 Soybean.

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

Soybean Production:

• Acreage and Areas ofSoybean Production

• Seed Production

• Organic Farming

• Specialty Soybean Production

• Soybean Cultivation Practices

Environmental Considerations:

• Soil and Land Use

• WaterResources

• Air Quality and Climate Change

• Gene Movement and Weediness

• Animals

• Plants

• Microorganisms

• Biodiversity



### 5Public Health Considerations:

• Worker Safety

• Human Health

Animal Feed Socioeconomic Issues:

• Domestic Economic Environment at Risk

• Trade Economic Environment at Risk

• Social Environment at Risk



### Alternatives that were fully analyzed The EA analyzes the potential environmental consequences ofa determination ofnonregulated
status ofMON 87705 Soybean. To respond favorably to a petition for nonregulated status, APHIS must determine that MON 87705 Soybean is unlikelyto pose a plant pestrisk. Based

on its Plant Pest Risk Assessment (USDA-APHIS, 2010) APHIS has concluded that MON 87705 Soybean is unlikely to pose a plant pest risk. Therefore, APHIS must determine that MON 87705 Soybean is no longer subject to 7 CFRpart 340 orthe plant pestprovisions ofthe Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination ofnonregulated status ofMON 87705 Soybean. APHIS has assessed the potential for environmental impacts for each alternative in the "Environmental Consequences" section ofthe EA.



### No Action: Continuation as a RegulatedArticle Underthe No Action Alternative, APHIS would denythe petition. MON 87705 Soybean and progenyderived from MON 87705 Soybean would continue to beregulated articles underthe regulations at 7 CFR Part 340. Permits issued ornotifications acknowledgedby APHIS would still berequired for introductions ofMON 87705 Soybean and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS might choose this alternative ifthere were insufficient evidence to demonstrate the lack ofplantpest risk from the unconfined cultivation ofMON 87705 Soybean.

This alternative is not the Preferred Alternative because APHIS has concluded through a Plant Pest Risk Assessment (USDA-APHIS, 2010) that MON 87705 Soybean is unlikely to pose a plantpest risk. Choosing this alternative would not satisfythe purpose and need ofmaking a determination ofplant pest risk status and responding to the petition for nonregulated status.



### Preferred Alternative: Determination thatMON 87705 

### Soybean is No Longer a Regulated Article Underthis alternative, MON 87705 Soybean and progeny derived from them would no longerbe regulated articles underthe regulations at 7 CFR Part 340. MON 87705 Soybean is unlikely to pose a plant pest risk (USDA-APHIS, 2010). Permits issued ornotifications acknowledged by APHIS would no longerbe required for introductions ofMON 87705 Soybean and progeny derived from this event. This alternative best meets the purpose andneed to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFRpart 340 and the agency's authority under the plantpest provisions ofthe Plant Protection Act. Because the agencyhas concluded that MON 87705 Soybean are unlikely to pose a plant pestrisk, a

6detennination ofnonregulated status ofMON 87705 soybean is a response that is consistent with theplantpestprovisions ofthe PPA, the regulations codified in 7 CFRpart 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. Underthis alternative, growers mayhave future access to MON 87705 Soybean and progenyderived from this event if the developer decides to commercialize MON 87705 Soybean.



### Alternatives Consideredbut Rejected from Further Consideration APHIS assembled a list ofalternatives that might be considered for MON 87705 Soybean. The agency evaluated these alternatives, in light ofthe agency's authority undertheplantpest provisions ofthe Plant Protection Act, and the regulations at 7 CFRpart 340, with respect to environmental safety, efficacy, and practicalityto identifywhich alternatives would be further considered for MON 87705 Soybean. Based on this evaluation, APHIS rejected several alternatives. These alternatives are discussedbrieflybelow along with the specific reasons for rejecting each.



### ProhibitanyMON87705Soybean from beingreleased In response to public comments that stated a preference that no GE organisms enterthe marketplace, APHIS consideredprohibitingthe release ofMON 87705 Soybean, including denying anypennits associated with the field testing. APHIS detennined that this alternative is
not appropriate given that APHIS has concluded that MON 87705 Soybean is unlikelyto pose a plantpest 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 bebased on sound science

... § 402(4).

On March 11,2011, in a Memorandum for the Heads ofExecutive Departments and Agencies, the White House EmergingTechnologies Interagency Policy Coordination Committee developed broadprinciples, consistentwith Executive Order 13563, to guidethe development and implementation ofpolicies for oversight ofemerging technologies (such as genetic engineering) at the agency level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principle, among others, to the extentpennittedbylaw, when regulating emergingtechnologies:

"[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and otherinfonnation, within the boundaries ofthe authorities and mandates ofeach agency"

Based on ourPlant Pest Risk Assessment (USDA-APHIS, 2010) and the scientific data evaluated therein, APHIS has concluded that MON 87705 Soybean is unlikelyto pose a plant pestrisk. Accordingly, there is no basis in science for prohibiting the release ofMON 87705 Soybean.



### Approvethepetition inpart

7The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole

or in part." For example, a determination ofnonregulated status in partmaybe appropriate if there is a plantpestrisk associated with some, but not all lines described in a petition. Because APHIS has concludedthat MON 87705 Soybean is unlikely to pose a plant pestrisk, there is no regulatorybasis under the plant pest provisions ofthe Plant Protection Act for considering approval ofthe pctition only in part.



### Isolation distance between MON87705 Soybean andnon-GEsoybean andgeographical restrictions In response to public concerns ofgene movement between GE and non-GE plants, APHIS considered requiring an isolation distance separatingMON 87705 Soybean from non-GE soybean production. However, because APHIS has concluded that MON 87705 Soybean is unlikely to pose a plant pest risk (USDA-APHIS, 2010), an alternative based on requiring isolation distances wouldbe inconsistent with the statutory authority under the plantpest provisions ofthe Plant Protection Act andregulations in 7 CFRpart 340.

APHIS also considered geographicallyrestricting theproduction ofMON 87705 Soybean based

on the location ofproduction ofnon-GE soybean in organic production systems in response to public concerns regarding possible gene movementbetween GE and non-GE plants. However,

as presented in APHIS' plantpestrisk assessment for MON 87705 Soybean, there are no geographic differences associated with any identifiable plant pestrisks for MON 87705 Soybean (USDA-APHIS, 2010). This alternative was rejected and not analyzed in detail because APHIS has concludedthat MON 87705 Soybean does notpose a plant pest risk, and will not exhibit a greater plantpestrisk in any geographically restricted area. Therefore, such an alternative would
notbe consistent with APHIS' statutoryauthority underthe plant pestprovisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnologyregulatory policies embodied in the Coordinated Framework.

Based on the foregoing, the imposition ofisolation distances or geographic restrictions would not meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFRpart 340 and the agency's authorityunderthe plantpest provisions ofthe Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. However, individuals might choose on their ownto geographically isolate their non-GE soybean productions systems from MON 87705 Soybean orto use isolation distances and other managementpractices to minimize gene movement benveen soybean fields.



### RequirementofTesting ForMON87705 Soybean During the comment periods for otherpetitions for nonregulated status, some commenters requested USDAto require and provide testing to identify GE products in non-GE production systems. APHIS notes there are no nationally-established regulations involving testing, criteria, orlimits ofGE material in non-GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, because MON 87705 Soybean does not pose a plant pest risk (USDA-APHIS, 2010), the imposition ofany type oftesting requirements is inconsistent with the plant pest provisions ofthe Plant Protection Act, the regulations at 7 CFRpart 340 and the biotechnology regulatorypolicies embodied in the Coordinated Framework. Therefore, imposing such a requirement for MON 87705 Soybean would not meet

8APHIS' 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.

(potential health



### 9Notes:

I. Unchanged the current conditions will not change as a result ofthe selection ofthis alternative. 2. Minimal the current conditions may change slightly as a result ofthe selection ofthis alternative. but the changes, if any, are not deemed significant.
Finding 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 soybean production systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commodity markets. In 2009 and 2010, over 75 million acres in the U.S. were planted in soybean, with over 93% ofthe soybean expressing herbicide tolerance (USDA-ERS, 20lOa, 2010b). In the U.S., soybeans are cultivated in 31 states; Table 2-2 in the EA, presents an overview ofthe 2009 and 2010 acreage ofsoybeans planted by state. Most ofthe soybean acreage in the U.S. is planted to GE soybean. Adoption ofgenetically engineered herbicidetolerant soybeans increased from 17% ofU.S. soybean acreage in 1997 to 68% in 2001 and 93% in 2010 (USDA-ERS, 201Oa, 201Ob). A determination ofnonregulated status ofMON 87705 Soybean is not expected to directly cause an increase in agricultural acreage devoted to soybean production or those soybean acres devoted to GE soybean cultivation. The availability of MON 87705 Soybean is not expected to change cultivation areas for soybean production in the U.S., and there are no anticipated changes to the availability ofGE and non-GE soybean varieties

on the market.

Although a determination ofnonregulated status ofMON 87705 Soybeanwould allow for new plantings ofMON 87705 Soybean to occur anywhere in the U.S., APHIS limited the environmental analysis to those geographic areas that currently support soybean production. A determination ofnonregulated status ofMON 87705 Soybean is not expected to increase soybean production, or result in an increase in overall GE soybean acreage or cultivation in new regions.

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

I. Impacts that may be both benefiCial andadverse. A determination ofnonregulated status ofMON 87705 Soybeanwill have no significant environmental impact in relation to the availability ofGE, conventional, organic or specialty soybean varieties. As discussed in Chapter 4 ofthe EA, a determination of nonregulated status ofMON 87705 Soybean is not expected to directly cause an increase 

### in agricultural acreage devoted to soybean production or those soybean acres devoted to GE soybean cultivation. The availability ofMON 87705 Soybean is not expected to change cultivation areas for soybean production in the U.S., and there are no anticipated changes to the availability ofGE and non-GE soybean varieties on the market. A

10determination ofnonregulated status ofMON 87705 Soybean will add another GE varietyto the existing soybean market and is not expected to change the market demands for GE soybean or soybean produced using organic methods or specialty systems. MON 87705 Soybean is expected to be cultivated as a high-value specialty soybeanproduct, produced under identityprotection systemmanagement practices so as to preserve the value ofthe oil (Monsanto, 2010). As a specialty soybean variety, Monsanto anticipates that MON 87705 Soybean wouldbe cultivated following existing specialty crop practices
to preserve product identity from seed production through harvesting, handling, and processing (Monsanto, 2010). Specialty soybean varieties are alreadycultivated on 12% ofthe U.S. soybean acreage, and the industry anticipates that specialty soybean acreage could expand to over25% ofthe crop in certain states within the next decade (MSA, 2009). Based on demonstrated agronomic characteristics and cultivationpractices, and because themarket share ofspecialty soybean varieties is unlikelyto change bythe introduction ofMON 87705 Soybean, APHIS has determined that there are no past, present, orreasonably foreseeable changes that would impact specialty soybean producers and consumers. Most ofthe soybean acreage in the U.S. is planted to GE soybean. MON 87705 Soybean would be an additional glyphosate-tolerant variety. Adoption ofgenetically engineered herbicide-tolerant soybeans increased from 17% of U.S. soybean acreage in 1997 to 68% in 2001 and 93% in 2010 (USDA-ERS, 2010a, 201Ob). Baseduponrecent trend information, adding GE varieties to the market is not related tothe ability oforganic production systems to maintaintheirmarket share. GE soybean varieties are currentlycultivated on 93% ofthe U.S. soybean acreage (USDA-ERS, 20IOa), and organic varieties comprise less than 1% ofthe total soybean acreage (USDA-ERS, 2010c). The acreage devoted to organic soybean is expected to remain small regardless ofwhether new varieties ofGE ornon-GE soybeanvarieties, includingMON 87705 Soybean, become available for commercial soybean production. Forthe time period of2005 to 2008, when the total U.S. acreage dedicatedto soybean fluctuated between 72 million and 64 million acres, the acreage devoted to organic soybeans was relatively stable, reported between 122,000 and 126,000 acres (USDA-ERS, 201Oc). MON 87705 Soybean should not present anynew
ordifferent issues and impacts for organic and other specialty soybean producers and

consumers. MON 87705 Soybean is not significantlydifferent in plant growth, yield, and reproductive capacity from its nontransgenic counterpart (Monsanto, 2010; USDAAPHIS, 2010). No differences were observed in pollen diameter, weight, and viability (Monsanto, 2010; USDA-APHIS, 2010). Consistent with the lack ofdifference in agronomic properties, MON 87705 Soybean is not expected to have an increased ability to cross pollinate other soybean varieties. Changes in the agronomic practices and locations for soybean seedproduction using MON 87705 Soybean are not expected. A determinationofnonregulated status ofMON 87705 Soybean is not expected to result in changes inthe current soybean cropping practices, including pesticide use. As discussed inChapter4 ofthe EA, studies demonstrate MON 87705 Soybean is essentially indistinguishable from other soybean varieties used in terms ofagronomic characteristics and cultivation practices (Monsanto, 2010). Monsanto did not identify any differences between MON 87705 Soybean and conventional in dormancy, germinationpotential, disease orinsect response, seedling vigor, orplant maturity (Monsanto, 2010; USDA-APHIS, 2010). A determination ofnon regulated status of

11MON 87705 Soybean is not expected to affect the use ofglyphosate as a post-emergent weed herbicide. The mechanism for glyphosate tolerance is the same as that expressed by other varieties, so the application rates for glyphosate are not expected to change (Monsanto, 2010). It is anticipated that herbicide use will continue the trends noted by Benbrook associated with the wide adoption ofglyphosate-tolerant soybean and the emergence ofglyphosate-resistant weeds (Benbrook, 2009). 

### 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofMON 87705 Soybeanwould have no significant impacts on human or animal health. Monsanto's intention in developing MON 87705 Soybean is the development ofa fatty acid profile which provides nutritional benefits bypresenting a healthier composition ofsaturated and unsaturated fats, as well as improved oil stability. As discussed in Chapter 4 ofthe EA, other than corresponding differences in fatty acid composition, no differences in human health impacts are anticipated. The FDA analysis (US-FDA, 2011) and Monsanto's data (Monsanto, 2010) suggest that replacing food oils with the soybean oil extracted from the MON 87705 Soybean may have a positive impact on human health in those cases where the replaced oil is a polyunsaturated product. The reduction in levels ofpolyunsaturated fatty acids in the MON 87705 Soybean oil is considered heart healthy. The extent to which this positive benefit may be observed is contingentupon the market share ofthe MON 87705 Soybean and the types offood products adapting the modified oil product. The FDA has completed its consultation on MON 87705 Soybean and has concluded that the product is not materially different in any respect relevant to food safety compared to soybean varieties currently on the market (US-FDA, 2011). The FDA's conclusions are based on an evaluation ofthe introduced protein, CP4 EPSPS, as well as the changes in the expression ofthe two endogenous genes resulting in modified fatty acid content. The EPA has also reviewed the safety ofthe CP4 EPSPS protein and has established a tolerance exemption for the protein and the genetic material necessary for its production in or on all raw agricultural commodities (US-EPA,**1996~** 40 CFR §174.523). The CP4 EPSPS protein expressed in MON 87705 Soybean is the same
as that previouslyreviewed by the EPA. Accordingly, MON 87705 Soybean is anticipated to be safe for human and animal consumption with regardto the 

### cp4 epsps gene. Based on the FDA's consultation (US-FDA, 2011), our analysis offield and laboratory data and scientific literature provided by Monsanto (Monsanto, 2010), and safety data available on other GE soybean, APHIS has concluded that a determination of nonregulated status ofMON 87705 Soybean would have no significant impacts on human or animal health. 

### 3. Unique characteristics of the geographic area such asproximity to historic or cultural

resources.parklands, prime farmlands, wetlands, wild andscenic rivers, or ecologically critical areas. There are no unique characteristics ofgeographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, orecologically critical areas that would be adversely impacted by a determination ofnonregulated status ofMON 87705 Soybean. The common agricultural practices that would be carried outunderthe proposed action will not cause major ground disturbance; do not cause anyphysical destruction or damage to property; do not cause any alterations ofproperty, wildlife habitat, or landscapes; and do not involve the sale, lease, or transfer ofownership ofanyproperty.

12This action is limited to a detennination ofnonregulated status ofMON 87705 Soybean. Theproduct will be deployed on agricultural land currently suitable for production of soybean and is not expected to increase the acreage ofsoybeanproduction. This action wouldnot convert land use to nonagricultural use and therefore would have no adverse impact on prime fann land. Standard agricultural practices for land preparation, planting, irrigation, and harvesting ofplants would be used on agricultural lands planted to MON 87705 Soybean, includingthe use ofEPA registered pesticides. Applicant's adherence
to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. In the event ofadetennination ofnonregulated status ofMON 87705 Soybean, the action is not likelyto affect historic orcultural resources, park lands, prime fannlands, wetlands, wild and scenic rivers, orecologically critical areas that may be in close proximityto soybean production sites. 

### 4. The degree to which the effects on the quality of the human environmentare likely to be highly controversial. The effects on the quality ofthehuman environment from a detennination of nonregulated status ofMON 87705 Soybean are not highlycontroversial. Although there is some opposition to a detennination ofnonregulated status ofMON 87705 Soybean, this action is nothighly controversial in tenns ofsize, nature or effect onthe natural orphysical environment. As discussed in Chapter4 ofthe EA, a determination ofnonregulated status ofMON 87705 Soybean is not expected to directly cause an increase in agricultural acreage devoted to soybean production orthose soybean acres devoted to GE soybeancultivation. The availability ofMON 87705 Soybean is not expected to change cultivation areas for soybean production in the U.S., and there are no anticipated changes to the availability ofGE and non-GE soybean varieties on the market. MON 87705 Soybean is not expected to result in changes in the current soybean croppingpractices, includingpesticide use. MON 87705 Soybean wouldbe

an additional glyphosate-tolerant variety. MON 87705 Soybean isnotexpectedto affect the use ofglyphosate as a post-emergent weed herbicide. The mechanism for glyphosate tolerance is the same as that expressedbyother varieties, so the application rates for glyphosate are not expected to change (Monsanto, 2010). Itis anticipated that herbicide

use will continue the trends noted byBenbrook associated with the wide adoption of glyphosate-tolerant soybean and the emergence ofglyphosate-resistant weeds (Benbrook, 2009). The effect ofMON 87705 Soybean on wildlife orbiodiversityis no differentthan that ofotherGE ornon-GE soybeanproduced in conventional agriculture in the U.S. Cultivation ofMON 87705 Soybean is highly unlikely to have direct toxic effects on non-target organisms and is likelytobeneutral to biodiversity compared with conventionallymanaged GE and non-GE soybean. During thepublic commentperiod, APHIS received comments opposing a determination ofnonregulated status ofMON 87705 Soybean. No new issues, alternatives or substantivenew infonnation were identified in anyofthe commentsreceived by APHIS. APHIS has addressed substantive
comments in the response to public comments document attached to this FONSIbased 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 thepossible effects on the human environment are well understood. The effects oftheproposed activities are nothighly

13uncertain and do not involve unique orunknown risks on the natural orphysical environment. As discussed in Chapter4 ofthe EA, a determination ofnonregulated
status ofMON 87705 Soybean is not expected to directly cause an increase in agricultural acreage devoted to soybean production orthose soybean acres devoted to GE soybean cultivation. A determination ofnonregulated status ofMON 87705 Soybean is not expected to result in changes in the current soybean croppingpractices, including pesticide use. As discussed in Chapter4 ofthe EA, studies demonstrate MON 87705 Soybean is essentially indistinguishable from other soybean varieties used in terms ofagronomic characteristics and cultivation practices (Monsanto, 2010). Monsanto did
not identify any differences between MON 87705 Soybean and conventional in dormancy, germination potential, disease orinsect response, seedling vigor, orplant maturity (Monsanto, 2010; USDA-APHIS, 2010). A determination ofnon regulated
status ofMON 87705 Soybean is not expected to affect the use ofglyphosate as a postemergent weed herbicide. MON 87705 Soybean would be an additional glyphosatetolerant variety. The mechanism for glyphosate tolerance is the same as that expressed byother varieties, so the application rates for glyphosate are not expected to change (Monsanto,201O). Itis anticipated that herbicide use will continue the trends noted by Benbrook associated with the wide adoption ofglyphosate-tolerant soybean and the emergence ofglyphosate-resistant weeds (Benbrook, 2009). The effect ofMON 87705 Soybean on wildlife orbiodiversity is no different than that ofother GE or non-GE soybeanproduced in conventional agriculture in the U.S. Cultivation ofMON 87705 Soybean is highlyunlikely to have direct toxic effects on non-target organisms and is likely to be neutral to biodiversity compared with conventionally managed GE and nonGE soybean. As described in Chapter4 ofthe EA, well established management practices, production controls, and production practices (GE, conventional, specialty and organic) are currentlybeing used in soybean production systems (commercial and seed production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce conventional soybean (GE and non-GE varieties), MON 87705 Soybean, orproduce soybean using organic methods or specialty systems, will continue to use these reasonable, commonly accepted best management practices for their chosen systems and varieties during agricultural soybean production. MON 87705 Soybean will add another GE variety to the existing soybean market and is not expected to change the market demands for GE soybean or soybean produced using organic methods or specialty systems. MON 87705 Soybean is expected to be cultivated as a high-value specialty soybean product, produced under identityprotection system management practices so as to preserve the value ofthe oil (Monsanto, 2010). As a specialty soybean variety, Monsanto anticipates that MON 87705 Soybean would be cultivated following existing specialty crop practices to preserve product identity from seed production through harvesting, handling, and processing (Monsanto, 2010). Specialty soybean varieties are already cultivated on 12% ofthe U.S. soybean acreage, and the industry anticipates that specialty soybean acreage could expand to over 25% ofthe crop in certain states within the next decade (MSA, 2009). Cultivation ofMON 87705 Soybean as a new specialty soybean variety should not present any new or different issues and impacts for specialty soybean producers and consumers. Based on demonstrated agronomic characteristics and cultivationpractices, and because the market share ofspecialty soybean varieties is unlikely to change bythe introduction ofMON 87705 Soybean, APHIS has determined

14that there are no past, present, orreasonably foreseeable changes that would impact specialty soybean producers and consumers. Additionally, most ofthe soybean acreage in the U.S. is planted to GE soybean. MON 87705 Soybean would be an additional glyphosate-tolerant variety. Adoption ofgenetically engineered herbicide-tolerant soybeans increased from 17% ofU.S. soybean acreage in 1997 to 68% in 2001 and 93% in 2010 (USDA-ERS, 2010a, 2010b). Based upon historic trends, conventional production practices that use GE varieties will likely continue to dominate in terms of acreage with orwithout a determination ofnonregulated status ofMON 87705 Soybean. Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use ofGE soybean products and specialty soybean varieties, the possible effects to the human environment from the release ofa an additional GE soybean product are already well known and understood. Therefore the impacts are not highly uncertain, and do not involve unique or unknown risks. 

### 6. The degree to which the action may establish aprecedent for future actions with significant effects or represents a decision inprinciple abouta future consideration. A determination ofnonregulated status ofMON 87705 Soybean 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 a plant pest risk pursuant to the regulatory requirements of7 CFR part 340. Each petition thatAPHIS receives is specific to a particularGE organism and undergoes this independent review to determine ifthe regulated article poses a plant pest risk. Underthe 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 by7 CFR 340.6, APHIS must respond to petitioners who request a determination ofthe regulated status ofGE organisms, including GE plants such as MON 87705 Soybean. When a petition for nonregulated status is submitted, APHIS must make a determination ifthe GE organism is unlikelyto pose a plant pestrisk. IfAPHIS determines based on its Plant Pest Risk Assessment that the genetically engineered organism is unlikely to pose a plantpestrisk, the genetically engineered organism is no longer subject to the plantpest provisions of the Plant Protection Act and 7 CFRpart 340. APHIS regulations at 7 CFRpart 340, which were promulgated pursuant to authority grantedbythe Plant Protection Act, 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 a plant pest. A GE organism is also regulated underPart 340 when APHIS has reason to believe that the GE organism maybe a plant pest orAPHIS does not have information to determine ifthe GE organism is unlikely to pose a plantpestrisk. A person maypetition the agency that a particular regulated article is unlikely to pose a plantpest risk, and, therefore, is no longerregulated underthe plant pestprovisions ofthe Plant Protection Act or the regulations at 7 CFR 340. Thepetitioner 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 greater plantpest risk than the

15unmodified organism. A GE organism is no longer subject to the regulatory requirements of7 CFR part 340 orthe plantpest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. 7. Whether the action is related to otheractions with individually insignificant but cumulatively**sign~ficant** impacts. No significant cumulative effects were identified through this assessment. The EA discussed cumulative effects on soybean management practices, human and animal health, and the environment and concluded that such impacts were not significant. A cumulative effects analysis is included for each environmental issue analyzed in Chapter 4 ofthe EA. In the event ofa determination ofnonregulated status, MON 87705 Soybean may be stacked (combined) with non-GE and GE soybean varieties by traditional breeding techniques, resulting in a plant that, for example, may also be resistanttoother herbicides, butmay also have progeny Vvith notransgenes at all. There is no guarantee that MON 87705 Soybean will be stacked with anyparticular non-GE or GE soybean varieties that are no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340, as company plans and market demands playa significant role in those business decisions. Thus, predicting all potential combinations ofstacked varieties that couldbe created using both non-GE and GE soybean varieties that are no longer subject to theplantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340 is hypothetical and purely speculative. In the event ofa determination of nonregulated status ofMaN 87705 Soybean, APHIS has not identified any significant impact on the environment which may result from the incremental impact ofa determination ofnonregulated status ofMON 87705 Soybean when added to otherpast, present, and reasonably foreseeable future actions. 8. The degree to which the action may adverselyaffect districts, sites, highways, structures,

or objects listed in or eligible for listing in the National Register of Historic Places or rnay cause loss ordestruction of significant sCient(fic, cultural, or historical resources. A determination ofnonregulated status ofMON 87705 Soybean is not expected to adversely impact cultural resources on tribal properties. Any farming activity that may be taken byfarmers on tribal lands are only conducted at the tribe's request; thus, the tribes have control over any potential conflict with cultural resources on tribal properties. A determination ofnonregulated status ofMaN 87705 Soybean would have no impaet

on districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register ofHistoric Places, nor would they likely cause any loss ordestruction ofsignificant scientific, cultural, orhistorical resources. This action is limited to a determination ofnonregulated status ofMON 87705 Soybean. Standard agricultural practices for land preparation, planting, irrigation, and harvesting ofplants wouldbe used

on agricultural lands planted to MaN 87705 Soybean, including the use ofEPA registered pesticides. Applicant's adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. A determination of nonregulated status ofMaN 87705 Soybean is not an undertaking that may directly or indirectly cause alteration in the character or use ofhistoric properties protected under the National Historic Preservation Act. In general, common agricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character or
use ofhistoric properties. For example, there is potential for audible effects on the use

16and enjoyment ofa historic property when common agricultural practices, such as the operation oftractors and othermechanical equipment, are conducted close to such sites. A built-in mitigating factor for this issue is that virtually all ofthe methods involved would onlyhave temporary effects on the audible nature ofa site and canbe ended at any time to restore the audible qualities ofsuch sites to theiroriginal condition with no further adverse effects. Additionally, these cultivation practices are already being conducted throughoutthe soybean production regions. The cultivation ofMON 87705 Soybean does not inherently change any ofthese agronomic practices so as to giverise to

an impact under theNHPA. 

### 9. The degree to which the action mayadverselyaffect an endangeredorthreatenedspecies

or its habitat that has been determined to be critical under the EndangeredSpeciesActof 1973. As described in Chapter4 ofthe EA, APHIS has analyzed the potential for effects from a determination ofnonregulated status ofMON 87705 Soybean on federally listed threatened and endangered species (TES) and speciesproposed for listing, as well as designated criticalhabitat and habitatproposed for designation, asrequired under Section 7 ofthe Endangered SpeciesAct. Afterreviewingpossible effects ofa determination of nonregulated status ofMON 87705 Soybean, APHIS has determined that a determination ofnonregulated status ofMON 87705 Soybean wouldhave no effect on federally listed threatened orendangered species and speciesproposed for listing, oron designated critical habitat orhabitat proposed for designation. 

### 10. Whether the action threatens a violation ofF ederal, State, orlocal law orrequirements imposed for theprotection of the environment. Theproposed action would be in compliance with all federal, state, and local laws. Becausethe agencyhas concluded that MON 87705 Soybean is unlikelyto pose a plant pestrisk, a determination ofnonregulated status ofMON 87705 Soybean is a response that is consistent with the plantpestprovisions ofthe PPA, theregulations codified in 7 CFRpart 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. MON 87705 Soybean falls within the scope ofthe 1992 FDA'spolicy statement concerningregulation ofproducts derived from newplant varieties, including those developed throughbiotechnology (US-FDA, 1992). In compliance with thispolicy, Monsanto initiated a consultation with the FDA on the food and feed safety and nutritional assessment summary for MON 87705 Soybean. A copy ofthe completed FDAreview is provided inAppendix A ofthe EA. EPA has authority underFIFRA to establishpesticide use restrictions; these use restrictions arepresented on pesticide labels which areprepared during the pesticideregistration process. The CP4 EPSPS protein expressed in MON 87705 Soybean is similar and functionally identical to endogenous plant EPSPS enzymes and is identical to the CP4 EPSPSs in other Roundup Ready® crops including Roundup Ready® soybean (40-3-2 and MON 89788). The EPA has also reviewed the safetyofthe CP4 EPSPS protein andhas established a tolerance exemption for theprotein and the genetic material necessary for its production in or on all raw agricultural commodities (US-EPA, 1996; 40 CFR 

### § 174.523). The CP4 EPSPS protein expressed in MON 87705 Soybean is the same as thatpreviouslyreviewed bythe EPA. There are no otherFederal, state, orlocal permitsthat are needed priorto the implementation ofthis action.

17

### NEPA Decision and Rationale I have carefully reviewed the EA prepared for this NEPA detennination and the input from the public involvement process. Ibelieve that the issues identified in the EA are best addressedby selecting Alternative 2 (Detennination that MON 87705 Soybean is No Longer a Regulated Article). This alternative meets APHIS' purpose and need to allow the safe development and use ofgenetically engineered organisms consistent with the plant pest provisions ofthe Plant Protection Act.

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the agency believes would fulfill its statutorymission and responsibilities, giving consideration to economic, environmental, technical and otherfactors." The preferred alternative has been selected for implementationbased on consideration ofa number ofenvironmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative 2 is selectedbecause (1) it allows APHIS to fulfill its statutorymission to protect America's agriculture and environment using a science-based regulatory framework that allows for the safe development and use of genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified any plantpest risks associated with MON 87705 Soybean, the continued regulated status ofMON 87705 Soybean would be inconsistentwith the plantpestprovisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. For the reasons stated above, I have detenninedthat a detennination ofnonregulated status ofMON 87705 Soybean will not have any significant environmental effects.

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



### Literature Cited:

Benbrook, C. (2009). Impacts ofGenetically Engineered Crops on Pesticide Use in the United States: The FirstThirteen Years. Critical Issue Report Number 3 (pp. 107): The Organic Center. Knothe, G. (2005). Dependence ofbiodiesel fuel properties on the structure offatty acid alkyl
esters. FuelProcessing Technology, 86( 1 0), 1059-1070. Graef, G., LaVallee, B. J., Tenopir, P., Tat, M., Schweiger, B., Kinney, A. J.,

... Clemente, T. E. (2009). A high-oleic-acid and low-palmitic-acid soybean: Agronomic perfonnance and evaluation as a feedstock for biodiesel. PlantBiotechnologyJournal, 7(5),411-421.

18Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved FattyAcid Profile MON 87705 Soybean. Submitted byG. Rogan. Monsanto Company, St. Louis, MO (See Table http://www.aphis.usda.gov/biotechnologv/not reg.html). MSA. (2009). Market Trends for IP Crops Retrieved November 29,2010, from http://w.Vv.W.mnshippers.com/html/news.cfm?ID=44 USDA-APHIS. (2010). Assessment ofPlant Pest Risk for MON 87705 Soybean. Riverdale, MD: US Department ofAgriculture, Animal and Plant Health Inspection Service, BiotechnologyRegulatory Services. US-EPA. (1996). 40 CFRPart 180 Plant Pesticide Inert Ingredient CP4 Enolpyruvylshikimate-3­ D and the Genetic Material Necessary for Its Production in All Plants. FederalRegister, 61(150),40338-40340. USDA-ERS. (20lOa). Adoption ofGenetically Engineered Crops in the U.S.

- Soybeans Varieties Retrieved November 29, 2010, from http://www.ers.usda.govlData/BiotechCrops/ExtentofAdoptionTable3.htm USDA-ERS. (2010b). Adoption ofGeneticallyEngineered Crops in the U.S. Retrieved November 29, 2010, from http://www.ers.usda.gov/datalbiotechcrops/ USDA-ERS. (2010c). Table 3--Certified Organic and Total U.S. Acreage, Selected Crops and Livestock, 1995-2008 Retrieved November 5, 2010, from http://www.ers.usda.govfData/Organic/ US-FDA. (1992). Statement ofPolicy

- Foods Derived from New Plant Varieties. Retrieved January 18, 2011, from http://www.fda.gov/FoodlGuidanceComplianceRegulatoryInformationlGuidanceDo cumentslBiotechnologylucm096095.htm US-FDA. (2011). Biotechnology Consultation

- Note to File No. 000121. College Park, MD: Department ofHealth and Human Services, Food and DrugAdministration. USDA-NASS. (2011a). Crop Production. Retrieved March 13,2011, from http://usda.mannlib.comell.edulusdalcurrentlCropProdlCropProd-03-10-20II.pdf USDA-NASS. (2011b). Crop Production 2010 Summary. Retrieved March 13,2011, from http://usda.mannlib.comell.edu/MannUsdalviewDocumentInfo.do?documentID=10 

### 47 USDA-OCE. (2011). USDA Agricultural Projections 2020. Retrieved March 9, 2011, from http://W\\-'w.usda.gov/oce!commoditylarchive projectionslUSDAAgriculturalProject ions2020.pdf

19Attachment Finding ofNo Significant Impact Response to Comments Petition 09-201-01p

Comment: Whi1e Monsanto in the petition and in theAddendum have presented a detailed risk managementplan, and outlined clear responsibilities for the parties and their obligations for maintaining channels for a segregated product, they wiJ] neither manage possible impacts nor accept responsibility or liability for the execution ofthe risk managementplan. Thus, Monsanto will not insure compliance orcommit to remedy adverse supply chain events. Theindustry consortium disagrees with Monsanto that a risk mitigation plan is not necessary to support the product.

Response: APHIS understands the difficult situation for industry entities thatprocess, produce and use oils ifadmixture ofMON 87705 and commodity orother specialty oils should occur. However, APHIS has no statutory authority for issues ofliability following adverse incidents in food and industrial oil production. APHIS is rcsponsible for regulating GE organisms and plants under the plant pest provisions in the Plant Protection Act of2000, as amended (7 USC § 7701 et seq.) to ensure that they do not pose a plant pest risk to the environment.

Monsanto does not expect that mitigation maybe needed, since it will be averted by combinations ofeconomic incentives, contracts and agreements, stewardship providing strong SOPs and the existing competence ofthe processors and sellers ofoil products. Monsanto proposes to maintain identitypreservation ofhigh oleic soybean through a closed loop stewardship plan; this comprehensive managementplan is acceptable to the commenter. Product integritywill be preservedbyrequirements for oil analysis throughout the supply chain, standard operatingprocedures, contracts or agreements, and segregated storage at each level ofpurchaser, processor and user. Critical control points are specified within the handlingprotocols at which certain processes and procedures must beundertaken. All parties to soybean oil production will be asked and must agree to observe conditions ofthe management plan. The components ofthe plan together serve to maintain the integrity ofthe seller and protect the interests ofthe buyer (see Appendix D, Fig. 2, p. 8 ofAddendum to Petition, Monsanto, 2010). The maintenance of product identity is thus enforced bymutuallybeneficial mechanisms agreed upon by the parties thatbuy, sell, use or transport the product oils. Finally, processors have sufficient experience in segregating, testing, and blending diverse specialized oils, and one more oil with different fatty acid content would not likely provide any new challenges to product identity (see EA, Appendix D: Monsanto, 2010, section 5. Stewardship: Market and Trade Assessment).

The components ofthe proposed stewardship plan are intended toprevent admixture ofMON 87705 soybean oil with standard commodity oil. The value ofthe specialty oil is dependent upon maintenance ofintegrity ofthe fatty acid profile with no admixture with standard commodity oils. Itis reasonable to assume that economic self-interest is a primary concern within the supply chain and among users and that the market will adequately regulate itselfto preserve the identity ofthis and otheroils produced for the food industry. Historically, the identity ofother types ofsoybean oils have been maintained using closed loop mechanisms, and with fuB integrity (e.g., as in the early years ofproduction ofvarious low linolenic acid varieties

20and high sucrose soybeans (Elbehri, 2007); various commercial specialty oilseeds supplied to processors, Clarkson, 2004)). APHIS is not aware ofany large scale failures ofthese special IP procedures when active stewardship is maintained by a developer, and as noted byRedick, (2005) "grower and grain associations

... insist[ed] on the use ofwell tested closed-loop identity preservation" systems even in the context ofindustrial traits expressed in commoditycrops.
Accordingto an USDA-ERS studyofgrainproduct identitypreservation, risk to the businesses involved inproduction and marketing arise from complying with contracts (deviating from specific standards, commingling issues, liability for qualityproblems, contract defaults in the supply chain) orare related to pricingfactors (loss ofpremiums oruncertainty ofreturn on longterm investment) (Elbeheri, 2007). To earn premiums from producing and processing specialty oils, producers necessarily have additional investments in the costs ofsegregating and preserving product identity, as well as for the cost ofmitigating risks (Elbehri, 2007). Risk managementin closed loop identitypreserved systems is morerobust than that ofsegregation mechanisms, since the risk manager oversees every detail ofproduct use from seedproduction through acceptance by the enduser; necessaryrisk managementprocedures entail rigorous quality control and tight chain ofcustodyprocesses (Redick, 2005; Elbehri, 2007). Typically,risk maybe shared under
terms ofa contractbetweenproducerand user; contracts may also be used to minimize production and transaction costs (Elbehri, 2007).

In the EA, APHIS has concluded that the risk ofimpacts from wide scale production ofMON 87705 to industry using soybeanoil is not likely to be significant given the comprehensive managementplan offered by Monsanto, and given the likelihood that this closed loop identity preserved plan is likely to be successful inpreventing admixture, because similarmanagement plans for specialty soybean oils have also been successful.

Clarkson, L. (2004). Niche oilseedsrequire identitypreservation. Processing Article. Inform 15 (8) 513 http://aocs.files.cms-plus.comlinforml2004/8/niche.pdf Elbehri, A. (2007). The Changing Face ofthe U.S. Grain System: Differentiation and Identity Preservation Trends, ERR-35. U.S. Dept. ofAgr., Econ. Res. Servo Feb. 2007. Monsanto. (2010) Petition for the Determination ofNonregulated Status for ImprovedFatty Acid Profile MON 87705 Soybean. Submitted byG. Rogan. Monsanto Company, St. Louis, MO (See Table http://www.aphis.usda.gov/biotechnology/not reg.html). Redick, T.P. (2005). LiabilityPrevention and Biotechnology: A BriefHistory ofSuccessful Industrial Stewardship. NABC Report 17: Agricultural Biotechnology: Beyond Food and Energy to Health andthe Environment. http://nabc.cals.comell.eduipubsinabc_17/partsINABCI7_Module4_2.pdf



### Comment: Monsanto plans to effectively commercialize MON 87705 soybean before all majormarkets have completed regulatory approval for legal importation. One soybean purchaserthathas not granted approval atthis pointis South Korea, which may become

an even largercustomer for US soybean when the currentFreeTradeAgreement with them is signed. Future soybean trade may bejeopardized ifMON 87705 soybean is commingled in current shipments and arrives withoutsuch approval. The full potential costs ofproducts ofnew technology should be shared between Monsanto and production chain partners by agreements madebetween the parties.

21Response: APHIS understands the importance ofobtaining the necessary regulatory approvals prior to commercializing MON 87705 Soybean and the associated trade implications. Global sensitivities to GE products, including international restrictions on import ofGE products and inability ofthe petitioner to gain approval for cultivation or importation, will continue to impede trade with those countries. These challenges to international trade in GE products are alreadyin place. Restrictions on international trade in GE products, including MON 87705 Soybean, are unlikelyto change with a determination ofnonregulated status ofMON 87705 Soybean.

To support commercial introduction ofMON 87705 Soybean in the US., Monsanto has indicated in theirpetition request ofnonregulated status ofMON 87705 Soybean that the necessaryregulatory submissions will be made bythe petitioner to countries that import significant quantities ofsoybean or its processed fractions from the US. and have established regulatory approval processes in place (Monsanto, 2010). To further limit commingling ofMON 87705 Soybean with commodity soybeans, Monsanto proposes to maintain identitypreservation ofhigh oleic soybean through a closed loop stewardship plan; this comprehensive management plan is acceptable to the commenter. Product integritywill bepreserved byrequirements for analysis, standard operatingprocedures, contracts or agreements, and segregated storage between each level ofprocessor and user (Monsanto, 2010). In the EA, APHIS has determined that the risk ofimpact on the soybean-using food industry following wide scale production ofMON 87705 is not likely to be significant given the management plan offered byMonsanto, and given that similar management plans for specialty soybean oils have been successful in preventing admixture (see previous Response to Comment).

The commenter notes that South Korea has thus far not approved the MON 87705 soybean line. Ifsome soybean could notbe shipped to this country until acceptance ofMON 87705 Soybean by South Korea's regulatory system had been completed, minimal impacts would be expected

on overall U.S. soybean trade, since US. whole soybean exports in 2010 to South Korea represented only 1.6% ofthe US. world export market (FAS, 2011a and 2011b). In addition, no
new market opportunities are anticipated for US. Soybeans. The USDA has predicted that U.S. exports will remain flat during much ofthe period extending through 2019 (FAPRI, 2009; USDA-ERS, 2009).

APHIS is responsible for regulating GE organisms and plants under the plantpestprovisions in the Plant Protection Act of2000, as amended (7 USC § 7701 et seq.) to ensure that they do not pose a plant pest risk to the environment. Because APHIS has concluded that MON 87705 Soybean is unlikely to pose a plant pest risk (USDA-APHIS, 201Oa), APHIS does not have the statutory authorityto impose further restrictions on MON 87705 Soybean.

FAPRI (2009). US. and World Agricultural OutlookFood and Agricultural Policy Research Institute. 395pp. http://w\vw.tapti.iastate.egu!outiook!2009! Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved FattyAcid Profile MON 87705 Soybean. Submitted by G. Rogan. Monsanto Company, St. Louis, MO (See Tableh!!I;l://www.aphis.lIsda.gov!biotechnologv/notreg.htm!). USDA-ERS (2009). Cotton: Background. USDA Economic Research Service. h!!p:!lwww.ers.usda.goviBriefing/Cotton!background.htm

22

### USDA-FAS (201Ia). Table 07: Soybeans: World Supply and Distribution. Foreign Agricultural Service. http://www.fas.usda.gov/psdonline/psdreportaspx?hidReportRetrievaIName:::::BVS&hidR eportRetrievaIID=706&hidReportRetrievaITemplateID=8 USDA-FAS (201Ib). Oilseeds. Production Supply Distribution (PSD Online Home 1 

### Downloadable Data Sets). Updated 9/12/11. 

### http://www.fas.usda.gov/psdonline/psdDownload.aspx

Comment: Two organizations representing grain handling businesses and allied end users, and ofanother representing companies and cooperatives producing and providing services to grain and oilseed exporting industry commentthatthey have concerns for impacts on international agriculture ifMON 87705 moves outside the closed loop system. While they appreciatethatthe management system proposed byMonsanto will appropriately manage the potential for commercial disruptions, they are concerned thatMonsanto has not publicaUy made "its commitmentto corporateresponsibility••• to all stakeholders in the value chain."

Response: Monsanto has indicated in their petition requesting nonregulated status for MON 87705 Soybean that the necessaryregulatory submissions will be made bythe petitioner to countries that import significant quantities ofsoybean orits processed fractions from the U.S. (Monsanto, 20I0). Regulatory packages will onlybe submitted to those countries which have establishedregulatory approval processes; notifications will be given those importing countries without formal approval systems (Monsanto, 20I0). During the time international authorizations for soybean are being sought for likely importing countries, Monsanto proposes to grow and marketthis product under a Closed Loop System. Historically, the identity ofother types of soybean oils have been maintained using closed loop mechanisms, and with full integrity (e.g., low linolenic acid varieties during early production years, low saturate soybean, etc. (Elbehri, 2007); various commercial specialtyoilseeds supplied tO'processors, Clarkson, 2004)). Deployment ofa closed loop system is consistent with the recommendations ofsoybean industry organizations which have requested "rigorous systems" to prevent unapproved (in the importing country) soybean varieties from entering foreign channels during trait development and seed production (ASA, 2011 download). APHIS is not aware ofany large scale failures ofthese IP procedures when the developer has instituted concerted stewardship efforts. In Section 4.6 ofthe EA, APHIS assesses that impacts resulting from adverse events, such as admixture ofthe specialty oil following a determination ofnonregulated status ofMON 87705 Soybean would not be different in consequence from those occurringunder the No Action Alternative.

While industry would appreciate assurance that adverse incidents would receive compensation from developers, APHIS assessment in the EA does not indicate that such events would cause significant overall impacts to U.S. trade. Given the types ofagreements, SOPs and practices that will be actuated in the proposed management system, these events are likely to be infrequent and their consequence in all likelihood not significant. Ifthese types ofevents were to occur, potential impacts wouldbe expected to be minimal. As Monsanto notes in the Addendum to the petition, three quality parameters importantto oil users can varyby as much as 14-15% without impacts on oil function, sensory properties, labelingrequirements, or on oil marketing and uses. At the farm level, an exceptionally large number ofmisdirected trucks carrying MON 87705



### 23soybean would be needed to effect significant change in these parameters characteristic of commodity soybean oil, given the large dilution volumes to which these oils are typically subjected (Monsanto, 2010, Addendum to Petition).

ASA. (2011 download). ASA Position. Biotechnology [Commercialization ofderegulated traits in major foreign markets]. American Soybean Association. h!.!n:!**I~'\:vw.soygrowers.com!issucs!biotechno** logy.htm Clarkson, L. (2004). Niche oilseeds require identitypreservation. ProcessingArticle. Inform 15 (8) 513 http://aocs.files.cms-plus.comlinfonn!2004/8/niche.pdf Elbehri, A. (2007). The Changing Face ofthe U.S. Grain System: Differentiation and Identity Preservation Trends, ERR-35. U.S. Dept. ofAgr., Econ. Res. Servo Feb. 2007. Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved Fatty Acid Profile MON 87705 Soybean. Submitted byG. Rogan. Monsanto Company, S1. Louis, MO (See Table http://www.aphis.llsda.govlbiotechnologv/not reg.html).

Comment: Concerns were expressed that genetically engineered crops might affect honey bee populations, already stressed from Colony Collapse Disorder. Decades ofresearch and monitoring may be needed to study impacts on insects, wildlife and birds. Response: First observed on the eastern U.S. coast inthe second halfof2006, honeybee colony collapse disorder (CCD) accounted for a decline ofapproximately 36 percent ofthe honeybee population (Johnson, 2010). 

### In contrast to otherprevious bee colony losses, CCD can be distinguished by several unusual attributes, including: 1) failure ofadult workerbees to return to the hive, despite the presence ofa brood and queen remaining in the hive; 2) relatively widespread and rapid colony loss throughout the entire year (i.e., not seasonal); and 3) that the mechanisms ofthe loss still remain unknown. Possible causes ofCCD includepathogens, parasites, environmental stresses, and bee management stresses (e.g., poornutrition); however, recent evidence suggests that CCD may represent a syndrome caused by a suite offactors interacting synergistically to produce rapid and wide-spread colonycollapse (USDA, 2009; Ratnieks et a1., 20I0, Mullin et at, 2010). Potential biotic and abiotic stresses correlatedwith CCD include, butmaynot be limited to: the single-celledparasiteNosema ceranae; Israeli acute paralysis virus (IAPV) and its potential vector, the Varma mite; orneonicotinoids, synthetic insecticides thatbindthe insect nicotinic acetylcholine receptor and other insecticides (Vidau et aI., 2011). However, correlation is not the same as causation. While several factors havebeen observed to be strongly correlated with CCD, few hypotheses have been experimentally verified and thus it is not currently known with certaintywhich factors produce CCD.

As the petitionernoted, APHIS states in the EA that soybeans are mostly self-pollinated; some research indicates that different cultivars are visited more or less frequently byhoneybees (Erickson, 1975). Although foraging honcybees and brood could potentially come into contact with MON 87705 pollen, toxins are not synthesized bythe genetic material altered in MON 87705 soybean. MON 87705 specificallydown-regulates two enzymes producing tatty acids by

an RNA interference mechanism. The site ofthe gene regulation is directed to the seeds, so pollen is not likely affected. Consequently, pollen safety is assured.

APHIS and FDA evaluated the changes in composition**ofMO~** 87705 Soybean with the nontransformed host variety, and with a number ofother commercial cultivars. Aside from the

24expected changes in fatty acid concentration, there were no biologically significant differences between MON 87705 Soybean andthese other cultivars (FDA, BiotechnologyConsultationNote to File 121). FDA's BNF states that "Monsanto has concluded that, with the exception ofthe intended change in fatty acid composition, soybean MON 87705 andthe foods and feeds derived from it are not materiallydifferent in composition, safety, orany otherrelevant parameter from other soybean varieties now grown, marketed, and consumed inthe U.S. At this time, based on Monsanto's data and information, the agency considers Monsanto's consultation on soybean MON 87705 to becomplete." FDA analysis concluded that there were no biologically significant differences between this soybean and others in commercial use that would have impacts on animal feed. Impacts on non-target animals and plants inthe environment from consuming orusing MON 87705 as habitat are unlikely, since there are no significant differences from the conventional cultivars.

APHIS evaluated in the EA Monsanto'spresentation ofobservations made ofpopulations ofpest insects (Monsanto, 2010, Table G-8) and ofbeneficial insects (Monsanto, 2010, Table G-9). APHIS concluded thatthere are no insectpopulation differences between the MON 87705 Soybean and control plants overmultiple field sites. Insectpopulation diversity represents one
measure ofgeneral impacts, and there were no differences observed at various times during development ofthe crop. In the absence ofanyobservable acute stresses orimpacts, there is no
reason to presume that long term impacts would be expected, nor that a need exists to monitor for them.

The MON 87705 Soybean will also have a glyphosate tolerance trait, which has alreadybeen widelyused inmanycrops overnumerous years. In the petition for MON 87705 Soybean, section, "0.2 Potential Impact ofGlyphosate on Human Health," and "0.3 Potential Impact of Glyphosate on the Environment," Monsanto summarizes EPA data onthe use ofglyphosate and impacts onthe environment, and notes that EPA concluded that glyphosate does notprovide an unreasonable risk to the environment (Monsanto, 2010).

From analyses ofthe effects ofthe genetic material in MON 87705, the lack oftoxicity ofthe soybean, no expected changes in agronomic practices betweenMON 87705 and conventional soybean, anypotential impact ofMON 87705 on the honeybee population or on otherwildlife is unlikely.

Erickson, E.H. (1975). Effect ofHoney Bees on Yield on Three Soybean Cultivars. Crop Science, 15, 84-86. Johnson, R. (2010). Honey Bee Colony Collapse Disorder. Congressional Research Service. January 7. Retrieved, April 12,2011, from: http://books.google.com/books?id=SxaJTt3KgoEC&lpg=PP1 &dq=Honey%20bee%20col ony<'102 Ocollapse%20disorder&pg=PP1 #v=onepage&q&f=false. Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved Fatty Acid Profile MON 87705 Soybean. SubmittedbyG. Rogan. Monsanto Company, St. Louis, MO (See Tablehttp://www.aphis.usda.govlbiotechnologylnotreg.htm]). Mullin, 

### c.A., Frazier, M., Frazier, J.L., Ashcraft, S., Simonds, R., vanEngelsdorp, D., Pettis, J.S. (2010). High Levels ofMiticides and Agrochemicals inNorth American Apiaries: Implications for Honey Bee Health. PLoS ONE 5:e9754.

25Ratnieks, F.L.W., Carreck, N.L. (2010) Clarity on honeybee collapse? Science 327: 152-153. USDA (2009). ColonyCollapse DisorderProgress Report. CCD Steering Committee. June 2009. Retrieved on March 24, from http://wv,lw.ars.usda.govlis!briccdh:cdpro!!ressreport.pdf Vidau, 

### c., Diogon, M., Aufauvre, J., Fontbonne, R., Vigue, B., Brunet, J.L., Texier, C., Biron, D.G., Blot, N., El Alaoui, H., Belzunces, L.P., Delbac, F. (2011). Exposure to Sublethal Doses ofFipronil and Thiacloprid Highly Increases Mortality ofHoneybees Previously InfectedbyNosema ceranae. PLoS ONE 6(6): e21550. doi: 10.13711joumal.pone.0021550.

Comment: One comment states thatMonsanto is not sharing safety tests on new products with peer reviewed science panels. Response: APHIS is responsible for regulating GE organisms and plants under the plant pest authorities in the Plant Protection Act of2000, as amended (7 USC § 7701 et seq.) to ensure that they do not pose a plantpest risk to the environment. A person maypetition the agency that a particularregulated article is unlikely to pose a plantpest risk, and, therefore, is no longer regulated under the plant pest provisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. Thepetitioner is required to provide information under § 340.6(c)(4) related to plantpest risk that the agency may use to determine whether the regulated article is unlikely to present a greaterplant pest risk than the unmodified organism. There is no regulatoryrequirement that information submittedbypetitioners to APHIS must bepeerreviewed by a scientific panel.

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) (see 7 U.S. 

### C. §7701(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 broad principles, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemerging technologies (such as genetic engineering)
at the agency level. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principle, among others, to the extentpermitted by law, when regulating emergingtechnologies:

"[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and otherinformation, within the boundaries ofthe authorities and mandates ofeach agency"

To assist APHIS in their scientific technical review ofa petition request, in accordance with APHIS regulatory requirements set forth in 7 CFRpart 340, APHIS makes each complete petition available for a 60 daypublic commentperiod. Petitions submittedby developers are announced in a Federal RegisterNotice and made publicly available on the APHIS website*. Petitions submittedby developers are made available to thepublic and inc1ude the methods used for experiments along with the subsequent observations and results. APHIS typically receives and fully considers responses from scientists made on the methodology used and the results summarized in the petition. These inputs allow APHIS to make an informed decision on the petition request, benefitting from external scientific expertise. APHIS may also directly consult

26with experts and scientists on specific issues to assure adequate analysis ofpossible environmental impacts.


### * http://www.aphis.lIsda.govlbiotechnology/notreg.html

Comment: Another comment asserts that GMOs increase cancer,increase spontaneous abortions, facilitate incorporation ofnewpathogens, and cite the letter to Agriculture SecretaryVilsackfrom retired ProfessorDon Huber as supportfor this contention.

Response: Professor Huber's letter alleges that either the gene to produce glyphosate tolerant crops orthe use ofglyphosate (Roundup) is either a promoter orcofactorthat facilitates a pathogen capable ofinfecting a variety ofsoybean, com, their products, various livestock and

."probablyhuman beings." The letter claims evidence for thepathogen in electron micrographs (which are notpublished) and alleges animal infertility (anecdotes, nonepublished, with no general corroboration), and a claim for escalating frequency ofGoss' wilt in com, and sudden death syndrome in soybean (no data to support the claims). Where animal abortions were noted,

an inference was made that animals consumed a wheatproduct, onwhich glyphosate mayhave been used. While these hypotheses are certainly remarkable, there was insufficient information

on methodology and results with which to make an evaluation. APHIS welcomes additional information from Professor Huber and others and will continue to evaluate new information with respect to APHIS decisions. APHIS encourages Professor Huber to publish his methods, results and conclusions, so that APHIS and the greater scientific community can fully evaluate his claims.

Comment: Various commenters allege that use ofglyphosate has adverse effects onhuman

. and animal health, and that a safety reviewis needed.

Response: The EAhas reported on the safety ofthe use ofglyphosate in the environmental consequences and cumulative impacts sections under various headings, including those on animals, plants, biodiversity, microbes and human health.

TheCP4 EPSPS protein used in MON 87705 Soybean confers tolerance to glyphosate. This protein is structurally homologous and similar functionally to endogenousplantEPSPS enzymes and is identical to the CP4 EPSPSs inother Rounduj Ready® crops, including Roundup Ready® soybean (40-3-2 and MON 89788, Roundup Ready canola, Roundup Ready® sugarbeet, Roundup Ready® flax, and Roundup Ready® cotton (http://www.aphis.usda.govlbiotechnology/not_reg.html). The first generation ofRoundup Ready® soybean (40-3-2) was determinedby APHIS to beno longer subject to the regulatory requirements of7 CFRPart 340 orthe plantpestprovisions ofthe Plant Protection Act in 1995 (http://www.aphis.usda.govlbiotechnology/notJeg.html). The cp4 epsps gene has been assessed extensivelyin the last 15 years. The safety ofCP4 EPSPS protein present in biotechnology derived crops has been evaluated as part ofcomprehensive reviews ofthe safety ofglyphosate exposure and ingestion (Harrison et at, 1996; see also Hammond et aI., 1996; Padgette et aI., 1996). The FDAhas reviewed the safety ofhuman consumption ofthe CP4 EPSPS protein in MON 87705 Soybean, and concluded that this protein presents negligible risk to human health from consumption (US-FDA, 2011).

27The EPA has also reviewed the safety ofthe CP4 EPSPS protein and has established a tolerance exemption for the protein and the genetic material necessary for its production in or on all raw agricultural commodities (US-EPA, 1996; 40 CFR § 174.523). This exemption is based on a safety assessment that included rapid digestion in simulated gastric fluids, lack ofhomology to known toxins and allergens, and lack oftoxicity in an acute oral mouse gavage study. The CP4 EPSPS protein expressed in MON 87705 Soybean is the same as thatpreviously reviewed bythe EPA. Accordingly, MON 87705 Soybean is anticipated to be safe for human and animal consumption with regard to the cp4 epsps gene.

EPA's Worker Protection Standard (WPS) (40 CFR Part 170) was published in 1992 to require actions to reduce the risk ofpesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS offers protections to more than two and a halfmillion agricultural workers who workwith pesticides atmore than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use ofpersonal protective equipment, restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance. During agricultural production ofsoybean, agricultural workers and pesticide applicators maybe exposed to a variety ofEPA registered pesticides (see, e.g., http://www.cdc.goviniosh/topics/pesticidesi). Such chemicals would be expected to include those products currently used for insect pest and plantpestmanagement in both GE and non-GE soybean cultivation, including the use ofglyphosate. Worker safety is taken into consideration when a pesticide label is developed during the registration process. When use is consistent with the label, pesticides including the glyphosate to be used with MON 87705 present minimal risk
to the worker.

Hammond, B. G., Vicini, 

### J. L., Hartnell, G. F., Naylor, M. W., Knight, C. D., Robinson, E. H.,

..

. Padgette, S. R (1996). The feeding value ofsoybeans fed to rats, chickens, catfish and dairy cattle is not altered by genetic incorporation ofglyphosate tolerance. The Journal of Nutrition, 126(3), 717-727. Harrison, L. A., Bailey, M. 

### R, Naylor, M. W., Ream, 

### J. E., Hammond, B. G., Nida, D. L.,

... Padgette, S. R (1996). The expressed protein in glyphosate-tolerant soybean, 5­ enolypyruvylshikimate-3-phosphate synthase fromAgrobacterium sp. strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice. The Journal of Nutrition, 126(3), 728-740. Padgette, S. R., Taylor, N. B., Nida, D. L., Bailey, M. 

### R, MacDonald, J., Holden, L. 

### R, & Fuchs, R L. (1996). The composition ofglyphosate-tolerant soybean seeds is equivalent
to that ofconventional soybeans. The Journal of Nutrition, 126(3), 702-716. US-EPA. (1996). 40 CFR Part 180 Plant Pesticide Inert Ingredient CP4 Enolpyruvylshikimate-3­ D and the Genetic Material Necessary for Its Production in All Plants. FederalRegister. 61(150),40338-40340. US-FDA. (2011). BiotechnologyConsultation

- Note to File No. 000121. College Park, MD: Department ofHealth and Human Services, Food and Drug Administration.

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