NATIONAL ENVIRONMENTAL POLICY ACT DECISION 


AND 


FINDING OF NO SIGNIFICANT IMPACT 


Monsanto 

Improved Fatty Acid Profile MON 87705 Soybean 

United States Department of Agriculture 


Animal and Plant Health 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 implementing NEPA, and the USDA APHIS' NEPA implementing 

regulations and procedures. This NEPA 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 NEP A decision. 

In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS has 

prepared an Environmental Assessment (EA) to evaluate and determine if there are any 

potentially significant impacts to the human environment from a determination on the regulated .. ;, 

status of a petition request (APHIS Number 09-201-01 p) by Monsanto for their transgenic 

soybean, event MON 87705 (hereafter referred to as MON 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, lower polyunsaturated (linoleic) fatty acid levels, and higher 

levels ofmonounsaturated (oleic) fatty acid (Monsanto, 2010). MON 87705 Soybean also 

expresses CP4 EPSPS protein throughout the plant conferring tolerance to glyphosate, which is 

the active ingredient in the Roundup® family of agricultural herbicides. This EA has been 

prepared in order to specifically evaluate the effects on the quality ofthe human environmentl 

that may result from a determination ofnonregulated status ofMON 87705 Soybean. The EA 

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. 

Regulatory Authority 

"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 of agricultural production (conventional, organic, or the use of 

genetically engineered (GE) varieties) can provide benefits to the environment, consumers, and 

farm income. 

Under NEP A regulations, the "human environment" includes "the natural and physical environment and the 

relationship ofpeople with that environment" (40 CFR §50S.14). 

1 

I 
Since 1986, the United States government has regulated genetically engineered (GE) organisms 

pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of 

Biotechnology (Coordinated Framework) (51 FR 23302,57 FR 22984). The Coordinated 

Framework, published by the Office of Science and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

products and explains how federal agencies will use existing Federal statutes in a manner to 

ensure public health and environmental safety while maintaining regulatory flexibility to avoid 

impeding the growth 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 extent permitted by their 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 only when 

there is evidence of "unreasonable" risk. 

The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA's APHIS, the Food and Drug 

Administration (FDA), and the Environmental Protection Agency (EPA). 

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

the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment. 

The FDA regulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic 

Act. The FDA is responsible for ensuring the safety and proper labeling of all plant-derived 

foods and feeds, including those that are genetically engineered. To help developers of food and 

feed derived from GE crops comply with their obligations under Federal food safety laws, FDA 

encourages them to participate in a voluntary consultation process. All food and feed derived 

from GE crops currently on the market in the United States have successfully completed this 

consultation process. The FDA policy statement concerning regulation of products derived from 

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

on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a 

eonsultation process to ensure that human food and animal feed safety issues or other regulatory 

issues (e.g., labeling) are resolved prior to commercial distribution ofbioengineered food. 

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and 

Rodentieide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides on and in food 

and animal feed, or establishes an exemption from the requirement for a tolerance, under the 

Federal Food, Drug and Cosmetic Act (FFDCA) and regulates certain biological control 

organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for 

regulating the sale, distribution and use of pesticides, including pesticides that are produced by 

an organism through teehniques of modem biotechnology. 

Regulated Organisms 

The APHIS Biotechnology Regulatory Service's (BRS) mission is to protect America's 

agriculture and environment using a dynamic and science-based regulatory framework that 

allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

2 
Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by 

the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the 

introduction (importation, interstate movement, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions ofthe 

Plant Protection Act or to the regulatory requirements of7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 

article ifthe donor organism, recipient organism, vector, or vector 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 under Part 340 when APHIS has reason to believe 

that the GE organism may be a plant pest or APHIS does not have information to determine if 

the GE organism is unlikely to pose a plant pest risk. 

A person may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated under the plant pest provisions ofthe Plant 

Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide information 

under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a 

plant pest risk. 

APHIS' Response to Petition for Nonregulated Status 

Under the authority ofthe plant pest provisions ofthe Plant Protection Act and 7 CFR Parl340, 

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 87705 Soybean. When a 

petition for nonregulated status is submitted, APHIS must make a determination ifthe GE 

organism is unlikely to pose a plant pest risk. IfAPHIS determines based on its Plant Pest Risk 

Assessment (PPRA) that the genetically engineered organism is unlikely to pose a plant pest risk, 

the genetically engineered organism is no longer subject to the plant pest provisions ofthe Plant 

Protection Act and 7 CFR part 340. 

Monsanto has submitted a petition (APHIS Number 09-201-01p) to APHIS seeking a 

determination that their transgenic soybean, MON 87705 Soybean, is unlikely to pose a plant 

pest risk and, therefore, should no longer be a regulated article under regulations at 7 CFR Part 

340. 

Improved Fatty Acid Profile Monsanto 87705 Soybean 

Monsanto has developed a transgenic soybean, MON 87705 Soybean, that produces 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 encoding the CP4 EPSPS 

protein. The cp4 epsps gene is used as a selectable marker to identify transgenic plants during 

3 

the transformation process. The CP4 EPSPS protein confers tolerance to glyphosate and has 

been used in many Roundup 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 weather performance, improved stability, and reduced nitrous oxide emissions 

(Graef et aI., 2009; Knothe, 2005). In addition to the altered fatty acid profile, the soybeans were 

engineered with glyphosate tolerance to provide growers of these soybeans with weed control 

options as well. 

Coordinated Framework Review 

Food and Drug Administration 

MON 87705 Soybean falls within the scope of the 1992 FDA's policy statement concerning 

regulation of products 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 of the 

EA. 

Environmental Protection Agency 

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 of and exposure to glyphosate. 

Scope of the Environmental Analysis 

Although a determination ofnonregulated status of MON 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 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. 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 of the 2009 and 

2010 aereage of soybeans 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 of the Monsanto petition, and the 

4 

APHIS PPRA and draft EA for a 60-day public review and comment period. Comments were 

required to be received on or before August 29, 20 II. All comments were carefully analyzed to 

identify new issues, alternatives, or information. A total of36 comment responses were received 

from various groups and individuals during the comment period, with 29 comments providing 

support of the EA's preferred alternative and 7 comments in opposition. Comment documents 

may be 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 by APHIS. 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 pest provisions ofthe Plant 

Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a 

determination ofnonregulated status ofMON 87705 Soybean. Issues discussed in the EA were 

developed by considering public concerns as well as issues raised in public comments submitted 

for other environmental assessments ofgenetically engineered organisms, concerns raised in 

lawsuits, as well as those issues that have been raised by various stakeholders. These issues, 

including those regarding the agricultural production of soybean using various production 

methods, and the environmental and food/feed safety of genetically engin~ered plants were 

addressed to analyze the potential environmental impacts ofMON 87705 Soybean. 

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): 

Soybean Production: 

• Acreage and Areas ofSoybean Production 

• Seed Production 

• Organic Farming 

• Specialty Soybean Production 

• Soybean Cultivation Practices 

Environmental Considerations: 

• Soil and Land Use 

• Water Resources 

• Air Quality and Climate Change 

• Gene Movement and Weediness 

• Animals 

• Plants 

• Microorganisms 

• Biodiversity 

5 

Public 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 of a determination ofnonregulated 

status ofMON 87705 Soybean. To respond favorably to a petition for nonregulated status, 

APHIS must determine that MON 87705 Soybean is unlikely to pose a plant pest risk. 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 CFR part 340 or the plant pest provisions ofthe 

Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) 

determination ofnonregulated status ofMON 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 Regulated Article 

Under the No Action Alternative, APHIS would deny the petition. MON 87705 Soybean and 

progeny derived from MON 87705 Soybean would continue to be regulated articles under the 

regulations at 7 CFR Part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions of MON 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 ofplant pest 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 

plant pest risk. Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated status. 

Preferred Alternative: Determination that MON 87705 Soybean is No Longer a Regulated 

Article 

Under this alternative, MON 87705 Soybean and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR Part 340. MON 87705 Soybean is unlikely to 

pose a plant pest risk (USDA-APHIS, 2010). Permits issued or notifications acknowledged by 

APHIS would no longer be required for introductions ofMON 87705 Soybean and progeny 

derived from this event. This alternative best meets the purpose and need to respond 

appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 

and the agency's authority under the plant pest provisions ofthe Plant Protection Act. Because 

the agency has concluded that MON 87705 Soybean are unlikely to pose a plant pest risk, a 

6 

detennination of nonregulated status of MON 87705 soybean is a response that is consistent with 

the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework. Under this alternative, 

growers may have future access to MON 87705 Soybean and progeny derived from this event if 

the developer decides to commercialize MON 87705 Soybean. 

Alternatives Considered but Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for MON 87705 Soybean. The 

agency evaluated these alternatives, in light ofthe agency's authority under the plant pest 

provisions ofthe Plant Protection Act, and the regulations at 7 CFR part 340, with respect to 

environmental safety, efficacy, and practicality to identify which alternatives would be further 

considered for MON 87705 Soybean. Based on this evaluation, APHIS rejected several 

alternatives. These alternatives are discussed briefly below along with the specific reasons for 

rejecting each. 

Prohibit any MON 87705 Soybean from being released 

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

marketplace, APHIS considered prohibiting the release ofMON 87705 Soybean, including 

denying any pennits associated with the field testing. APHIS detennined that this alternative is 

not appropriate given that APHIS has concluded that MON 87705 Soybean 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 of Executive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

implementation ofpolicies for oversight of emerging technologies (such as genetic engineering) 

at the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563 and, consistent with that Executive Order, the following principle, among others, to 

the extent pennitted by law, when regulating emerging technologies: 

"[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other infonnation, within the boundaries of the authorities and mandates 

of each agency" 

Based on our Plant Pest Risk Assessment (USDA-APHIS, 2010) and the scientific data 

evaluated therein, APHIS has concluded that MON 87705 Soybean is unlikely to pose a plant 

pest risk. Accordingly, there is no basis in science for prohibiting the release of MON 87705 

Soybean. 

Approve the petition in part 

7 

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

or in part." For example, a determination ofnonregulated status in part may be appropriate if 

there is a plant pest risk associated with some, but not all lines described in a petition. Because 

APHIS has concluded that MON 87705 Soybean is unlikely to pose a plant pest risk, there is no 

regulatory basis under the plant pest provisions ofthe Plant Protection Act for considering 

approval of the pctition only in part. 

Isolation distance between MON 87705 Soybean and non-GE soybean and geographical 

restrictions 

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating MON 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 would be inconsistent with the statutory authority under the plant pest 

provisions ofthe Plant Protection Act and regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production ofMON 87705 Soybean based 

on the location ofproduction ofnon-GE soybean in organic production systems in response to 

public concerns regarding possible gene movement between GE and non-GE plants. However, 

as presented in APHIS' plant pest risk assessment for MON 87705 Soybean, there are no 

geographic differences associated with any identifiable plant pest risks for MON 87705 Soybean 

(USDA-APHIS, 2010). This alternative was rejected and not analyzed in detail because APHIS 

has concluded that MON 87705 Soybean does not pose a plant pest risk, and will not exhibit a 

greater plant pest risk in any geographically restricted area. Therefore, such an alternative would 

not be consistent with APHIS' statutory authority under the plant pest provisions of the Plant 

Protection Act and regulations in Part 340 and the biotechnology regulatory policies embodied in 

the Coordinated Framework. 

Based on the foregoing, the imposition 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 CFR part 340 and the agency's authority under the plant pest 

provisions ofthe Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. 

However, individuals might choose on their own to geographically isolate their non-GE soybean 

productions systems from MON 87705 Soybean or to use isolation distances and other 

management practices to minimize gene movement benveen soybean fields. 

Requirement ofTesting For MON 87705 Soybean 

During the comment periods for other petitions for nonregulated status, some commenters 

requested USDA to require and provide testing to identify GE products in non-GE production 

systems. APHIS notes there are no nationally-established regulations involving testing, 

criteria, or limits 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 of any type of testing requirements 

is inconsistent with the plant pest provisions ofthe Plant Protection Act, the regulations at 7 

CFR part 340 and the biotechnology regulatory policies embodied in the Coordinated 

Framework. Therefore, imposing such a requirement for MON 87705 Soybean would not meet 

8 

APHIS' purpose and need to respond appropriately to the petition in accordance with its 

regulatory authorities. 

Environmental Consequences of APHIS' Selected Action 

The EA contains a full analysis ofthe alternatives to which we refer the reader for specific 

details. The following table briefly summarizes the results for each of the issues fully analyzed 

in the Environmental Consequences section of the EA. 

(potential health 

9 

Notes: 

I. 	 Unchanged the current conditions will not change as a result of the selection of this alternative. 

2. 	 Minimal the current conditions may change slightly as a result of the selection of this alternative. but the changes, if 

any, are not deemed significant. 

Finding of No Significant Impact 

The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality 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 NEP A 

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% of the soybean expressing herbicide tolerance (USDA-ERS, 20 lOa, 

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 of soybeans planted by state. Most of the soybean 

acreage in the U.S. is planted to GE soybean. Adoption of genetically engineered herbicidetolerant soybeans increased from 17% of U.S. soybean acreage in 1997 to 68% in 2001 and 93% 

in 2010 (USDA-ERS, 201 Oa, 201 Ob). A determination of nonregulated status of MON 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 Soybean would allow for new 

plantings of MON 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 of the degree or severity of an impact based upon the ten 

factors. The following factors were used as a basis for this decision: 

I. Impacts that may be both benefiCial and adverse. 

A determination of nonregulated status of MON 87705 Soybean will have no significant 

environmental impact in relation to the availability of GE, conventional, organic or 

specialty soybean varieties. As discussed in Chapter 4 ofthe EA, a determination of 

nonregulated status of MON 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 

10 
determination ofnonregulated status ofMON 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 identity protection 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). Based on demonstrated agronomic characteristics and cultivation practices, and 

because the market share of specialty soybean varieties is unlikely to change by the 

introduction ofMON 87705 Soybean, APHIS has determined that there are no past, 

present, or reasonably 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, 

201 Ob). Based upon recent trend information, adding GE varieties to the market is not 

related to the ability of organic production systems to maintain their market share. 

GE soybean varieties are currently cultivated 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 of whether new varieties of GE or non-GE soybean varieties, 

including MON 87705 Soybean, become available for commercial soybean 

production. For the time period of 2005 to 2008, when the total U.S. acreage 

dedicated to 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, 201 Oc). MON 87705 Soybean should not present any new 

or different issues and impacts for organic and other specialty soybean producers and 

consumers. MON 87705 Soybean is not significantly different 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 seed production using MON 87705 Soybean are not expected. A 

determination ofnonregulated status ofMON 87705 Soybean is not expected to result in 

changes in the current soybean cropping practices, including pesticide use. As 

discussed in Chapter 4 ofthe EA, studies demonstrate MON 87705 Soybean is 

essentially indistinguishable from other soybean varieties used in terms of agronomic 

characteristics and cultivation practices (Monsanto, 2010). Monsanto did not identify 

any differences between MON 87705 Soybean and conventional in dormancy, 

germination potential, disease or insect response, seedling vigor, or plant maturity 

(Monsanto, 2010; USDA-APHIS, 2010). A determination of non regulated status of 

11 

MON 87705 Soybean is not expected to affect the use of glyphosate 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 of glyphosate-tolerant soybean and the 

emergence of glyphosate-resistant weeds (Benbrook, 2009). 

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

A determination ofnonregulated status ofMON 87705 Soybean would have no 

significant impacts on human or animal health. Monsanto's intention in developing 

MON 87705 Soybean is the development of a fatty acid profile which provides 

nutritional benefits by presenting a healthier composition of saturated and unsaturated 

fats, as well as improved oil stability. As discussed in Chapter 4 of the 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 of polyunsaturated 

fatty acids in the MON 87705 Soybean oil is considered heart healthy. The extent to 

which this positive benefit may be observed is contingent upon the market share ofthe 

MON 87705 Soybean and the types of food 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 of the introduced protein, CP4 EPSPS, as 

well as the changes in the expression of the 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-EP A, 1996~ 40 

CFR § 174.523). The CP4 EPSPS protein expressed in MON 87705 Soybean is the same 

as that previously reviewed by the EPA. Accordingly, MON 87705 Soybean is 

anticipated to be safe for human and animal consumption with regard to 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 ofthe geographic area such as proximity to historic or cultural 

resources. park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically 

critical areas. 

There are no unique characteristics of geographic areas such as park lands, prime farm 

lands, wetlands, wild and scenic areas, or ecologically critical areas that would be 

adversely impacted by a determination ofnonregulated status ofMON 87705 Soybean. 

The common agricultural practices that would be carried out under the proposed action 

will not cause major ground disturbance; do not cause any physical destruction or 

damage to property; do not cause any alterations of property, wildlife habitat, or 

landscapes; and do not involve the sale, lease, or transfer of ownership of any property. 

12 
This action is limited to a detennination ofnonregulated status ofMON 87705 Soybean. 

The product will be deployed on agricultural land currently suitable for production of 

soybean and is not expected to increase the acreage ofsoybean production. This action 

would not 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, 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. In the event ofa detennination ofnonregulated status ofMON 

87705 Soybean, the action is not likely to affect historic or cultural resources, park lands, 

prime fannlands, wetlands, wild and scenic rivers, or ecologically critical areas that may 

be in close proximity to soybean production sites. 

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

highly controversial. 

The effects on the quality ofthe human environment from a detennination of 

nonregulated status ofMON 87705 Soybean are not highly controversial. Although 

there is some opposition to a detennination ofnonregulated status ofMON 87705 

Soybean, this action is not highly controversial in tenns ofsize, nature or effect on the 

natural or physical environment. 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 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. MON 87705 Soybean is not expected to result in changes in the current 

soybean cropping practices, including pesticide use. MON 87705 Soybean would be 

an additional glyphosate-tolerant variety. MON 87705 Soybean is not expected to affect 

the use of glyphosate 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 of 

glyphosate-tolerant soybean and the emergence of glyphosate-resistant weeds (Benbrook, 

2009). The effect ofMON 87705 Soybean on wildlife or biodiversity is no different than 

that ofother GE or non-GE soybean produced 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 likely to be neutral to biodiversity compared with 

conventionally managed GE and non-GE soybean. During the public comment period, 

APHIS received comments opposing a determination ofnonregulated status ofMON 

87705 Soybean. No new issues, alternatives or substantive new infonnation were 

identified in any ofthe comments received by APHIS. APHIS has addressed substantive 

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

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

5. 	 The degree to which the possible effects on the human environment are highly uncertain 

or involve unique or unknown risks. 

Based on the analysis documented in the EA the possible effects on the human 

environment are well understood. The effects ofthe proposed activities are not highly 

13 
uncertain and do not involve unique or unknown risks on the natural or physical 

environment. As discussed in Chapter 4 ofthe EA, a determination of nonregulated 

status of MON 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. A determination ofnonregulated status ofMON 87705 

Soybean is not expected to result in changes in the current soybean cropping practices, 

including pesticide use. As discussed in Chapter 4 ofthe EA, studies demonstrate MON 

87705 Soybean is essentially indistinguishable from other soybean varieties used in terms 

of agronomic characteristics and cultivation practices (Monsanto, 2010). Monsanto did 

not identify any differences between MON 87705 Soybean and conventional in 

dormancy, germination potential, disease or insect response, seedling vigor, or plant 

maturity (Monsanto, 2010; USDA-APHIS, 2010). A determination of non regulated 

status of MON 87705 Soybean is not expected to affect the use of glyphosate 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 

by other varieties, so the application rates for glyphosate are not expected to change 

(Monsanto,201O). It is anticipated that herbicide use will continue the trends noted by 

Benbrook associated with the wide adoption of glyphosate-tolerant soybean and the 

emergence ofglyphosate-resistant weeds (Benbrook, 2009). The effect ofMON 87705 

Soybean on wildlife or biodiversity is no different than that of other GE or non-GE 

soybean produced 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 

likely to be neutral to biodiversity compared with conventionally managed GE and nonGE soybean. As described in Chapter 4 ofthe EA, well established management 

practices, production controls, and production practices (GE, conventional, specialty and 

organic) are currently being 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, or produce 

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 identity protection 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 of MON 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 

cultivation practices, and because the market share of specialty soybean varieties is 

unlikely to change by the introduction ofMON 87705 Soybean, APHIS has determined 

14 
that there are no past, present, or reasonably foreseeable changes that would impact 

specialty soybean producers and consumers. Additionally, most of the soybean acreage 

in the U.S. is planted to GE soybean. MON 87705 Soybean would be an additional 

glyphosate-tolerant variety. Adoption of genetically 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, 2010b). Based upon historic trends, conventional 

production practices that use GE varieties will likely continue to dominate in terms of 

acreage with or without a determination ofnonregulated status ofMON 87705 Soybean. 

Given the extensive experience that APHIS, stakeholders, and growers have in dealing 

with the use of GE soybean products and specialty soybean varieties, the possible effects 

to the human environment from the release of a 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 a precedent for future actions with 

significant effects or represents a decision in principle about a 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. Similar to past regulatory requests reviewed and approved by 

APHIS, a determination of nonregulated status will be based upon an independent 

determination on whether an organism is unlikely to pose a plant pest risk pursuant to the 

regulatory requirements of7 CFR part 340. Each petition that APHIS receives is specific 

to a particular GE organism and undergoes this independent review to determine if the 

regulated article poses a plant pest risk. Under the authority ofthe plant pest provisions 

ofthe Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the 

safe development and use ofGE organisms. As required by 7 CFR 340.6, APHIS must 

respond to petitioners who request a determination 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 if the GE organism 

is unlikely to pose a plant pest risk. IfAPHIS determines based on its Plant Pest Risk 

Assessment that the genetically engineered organism is unlikely to pose a plant pest risk, 

the genetically engineered organism is no longer subject to the plant pest provisions of 

the Plant Protection Act and 7 CFR part 340. APHIS regulations at 7 CFR part 340, 

which were promulgated pursuant to authority granted by the Plant Protection Act, as 

amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction 

(importation, interstate movement, or release into the environment) of certain GE 

organisms and products. A GE organism is considered a regulated article ifthe donor 

organism, recipient organism, vector, or vector 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 under Part 340 when APHIS has reason to 

believe that the GE organism may be a plant pest or APHIS does not have information to 

determine if the GE organism is unlikely to pose a plant pest risk. A person may petition 

the agency that a particular regulated article is unlikely to pose a plant pest risk, and, 

therefore, is no longer regulated under the plant pest provisions of the Plant Protection 

Act or the regulations at 7 CFR 340. The petitioner is required to provide information 

under § 340.6(c)(4) related to plant pest risk that the agency may use to determine 

whether the regulated article is unlikely to present a greater plant pest risk than the 

15 
unmodified organism. A GE organism is no longer subject to the regulatory requirements 

of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS 

determines that it is unlikely to pose a plant pest risk. 

7. 	 Whether the action is related to other actions 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 of a determination of nonregulated 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 

resistant to other herbicides, but may also have progeny Vvith no transgenes at all. There 

is no guarantee that MON 87705 Soybean will be stacked with any particular non-GE or 

GE soybean varieties that are no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340, as company plans and market demands playa 

significant role in those business decisions. Thus, predicting all potential combinations 

of stacked varieties that could be created using both non-GE and GE soybean varieties 

that are no longer subject to the plant pest provisions of the Plant Protection Act and 7 

CFR part 340 is hypothetical and purely speculative. In the event of a determination of 

nonregulated status of MaN 87705 Soybean, APHIS has not identified any significant 

impact on the environment which may result from the incremental impact of a 

determination ofnonregulated status ofMON 87705 Soybean when added to other past, 

present, and reasonably foreseeable future actions. 

8. 	 The degree to which the action may adversely affect districts, sites, highways, structures, 

or objects listed in or eligible for listing in the National Register ofHistoric Places or 

rnay cause loss or destruction ofsignificant 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 by farmers 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 of nonregulated status of MaN 87705 Soybean would have no impaet 

on districts, sites, highways, structures, or objects listed in or eligible for listing in the 

National Register of Historic Places, nor would they likely cause any loss or destruction 

of significant scientific, cultural, or historical resources. This action is limited to a 

determination ofnonregulated status ofMON 87705 Soybean. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting ofplants would be used 

on agricultural lands planted to MaN 87705 Soybean, 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. A determination of 

nonregulated status ofMaN 87705 Soybean is not an undertaking that may directly or 

indirectly cause alteration in the character or use of historic properties protected under the 

National Historic Preservation Act. In general, common agricultural activities conducted 

under this action do not have the potential to introduce visual, atmospheric, or audible 

elements to areas in which they are used that could result in effects on the character or 

use of historic properties. For example, there is potential for audible effects on the use 

16 
and enjoyment of a 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 that virtually all ofthe methods involved 

would only have temporary effects on the audible nature of a site and can be ended at any 

time to restore the audible qualities ofsuch sites to their original condition with no 

further adverse effects. Additionally, these cultivation practices are already being 

conducted throughout the soybean production regions. The cultivation ofMON 87705 

Soybean does not inherently change any ofthese agronomic practices so as to give rise to 

an impact under the NHPA. 

9. 	 The degree to which the action may adversely affect an endangered or threatened species 

or its habitat that has been determined to be critical under the Endangered Species Act of 

1973. 

As described in Chapter 4 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 species proposed for listing, as well as 

designated critical habitat and habitat proposed for designation, as required under Section 

7 ofthe Endangered Species Act. After reviewing possible effects ofa determination of 

nonregulated status ofMON 87705 Soybean, APHIS has determined that a 

determination of nonregulated status of MON 87705 Soybean would have no effect on 

federally listed threatened or endangered species and species proposed for listing, or on 

designated critical habitat or habitat proposed for designation. 

10. 	 Whether the action threatens a violation ofFederal, State, or local law or requirements 

imposedfor the protection ofthe environment. 

The proposed action would be in compliance with all federal, state, and local laws. 

Because the agency has concluded that MON 87705 Soybean is unlikely to pose a plant 

pest risk, a determination ofnonregulated status ofMON 87705 Soybean is a response 

that is consistent with the plant pest provisions ofthe PP A, the regulations codified in 7 

CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. 

MON 87705 Soybean falls within the scope ofthe 1992 FDA's policy 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. 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). 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 previously reviewed by the EPA. 

There are no other Federal, state, or local permits that are needed prior to 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. I believe that the issues identified in the EA are best addressed by 

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 

of genetically engineered organisms consistent with the plant pest provisions ofthe Plant 

Protection Act. 

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the 

agency believes would fulfill its statutory mission and responsibilities, giving consideration to 

economic, environmental, technical and other factors." The preferred alternative has been 

selected for implementation based on consideration of a number of environmental, regulatory, 

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

it allows APHIS to fulfill its statutory mission to protect America's agriculture and environment 

using a science-based regulatory framework that allows for the safe development and use of 

genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory 

obligations. As APHIS has not identified any plant pest risks associated with MON 87705 

Soybean, the continued regulated status ofMON 87705 Soybean would be inconsistent with the 

plant pest provisions ofthe PPA, the regulations codified at 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework. For the reasons stated above, I 

have detennined that 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 First Thirteen 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. Fuel Processing 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. Plant Biotechnology Journal, 7(5),411-421. 

18 

Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved Fatty Acid 

Profile MON 87705 Soybean. Submitted by G. 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 of Plant Pest Risk for MON 87705 Soybean. Riverdale, MD: 

US Department ofAgriculture, Animal and Plant Health Inspection Service, 

Biotechnology Regulatory Services. 

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. Federal Register, 

61(150),40338-40340. 

USDA-ERS. (20 lOa). Adoption of Genetically 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 of Genetically Engineered 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 Drug Administration. 

USDA-NASS. (2011a). Crop Production. Retrieved March 13,2011, 

from http://usda.mannlib.comell.edulusdalcurrentlCropProdlCropProd-03-10-20 II.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 

19 

Attachment 

Finding of No Significant Impact 

Response to Comments 

Petition 09-201-01p 

Comment: Whi1e Monsanto in the petition and in the Addendum have presented a detailed 

risk management plan, 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 of the risk 

management plan. Thus, Monsanto will not insure compliance or commit to remedy 

adverse supply chain events. The industry 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 that process, produce 

and use oils if admixture of MON 87705 and commodity or other specialty oils should occur. 

However, APHIS has no statutory authority for issues of liability 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 may be needed, since it will be averted by 

combinations of economic incentives, contracts and agreements, stewardship providing strong 

SOPs and the existing competence of the processors and sellers of oil products. Monsanto 

proposes to maintain identity preservation of high oleic soybean through a closed loop 

stewardship plan; this comprehensive management plan is acceptable to the commenter. Product 

integrity will be preserved by requirements for oil analysis throughout the supply chain, standard 

operating procedures, contracts or agreements, and segregated storage at each level ofpurchaser, 

processor and user. Critical control points are specified within the handling protocols at which 

certain processes and procedures must be undertaken. All parties to soybean oil production will 

be asked and must agree to observe conditions of the management plan. The components ofthe 

plan together serve to maintain the integrity of the seller and protect the interests ofthe buyer 

(see Appendix D, Fig. 2, p. 8 of Addendum to Petition, Monsanto, 2010). The maintenance of 

product identity is thus enforced by mutually beneficial mechanisms agreed upon by the parties 

that buy, 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 of the proposed stewardship plan are intended to prevent admixture ofMON 

87705 soybean oil with standard commodity oil. The value of the specialty oil is dependent 

upon maintenance of integrity of the fatty acid profile with no admixture with standard 

commodity oils. It is 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 itself to 

preserve the identity ofthis and other oils produced for the food industry. Historically, the 

identity of other types of soybean oils have been maintained using closed loop mechanisms, and 

with fuB integrity (e.g., as in the early years ofproduction of various low linolenic acid varieties 

20 

and high sucrose soybeans (Elbehri, 2007); various commercial specialty oilseeds supplied to 

processors, Clarkson, 2004)). APHIS is not aware of any large scale failures ofthese special IP 

procedures when active stewardship is maintained by a developer, and as noted by Redick, 

(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 commodity crops. 

According to an USDA-ERS study ofgrain product identity preservation, risk to the businesses 

involved in production and marketing arise from complying with contracts (deviating from 

specific standards, commingling issues, liability for quality problems, contract defaults in the 

supply chain) or are related to pricing factors (loss of premiums or uncertainty 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 management in 

closed loop identity preserved systems is more robust than that ofsegregation mechanisms, since 

the risk manager oversees every detail ofproduct use from seed production through acceptance 

by the end user; necessary risk management procedures entail rigorous quality control and tight 

chain of custody processes (Redick, 2005; Elbehri, 2007). Typically, risk may be shared under 

terms of a contract between producer and 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 soybean oil is not likely to be significant given the comprehensive 

management plan offered by Monsanto, and given the likelihood that this closed loop identity 

preserved plan is likely to be successful in preventing admixture, because similar management 

plans for specialty soybean oils have also been successful. 

Clarkson, L. (2004). Niche oilseeds require identity preservation. 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 Improved Fatty Acid 

Profile MON 87705 Soybean. Submitted by G. Rogan. Monsanto Company, St. Louis, 

MO (See Table http://www.aphis.usda.gov/biotechnology/not reg.html). 

Redick, T.P. (2005). Liability Prevention and Biotechnology: A BriefHistory of Successful 

Industrial Stewardship. NABC Report 17: Agricultural Biotechnology: Beyond Food and 

Energy to Health and the Environment. 

http://nabc.cals.comell.eduipubsinabc_17/partsINABCI7_Module4_2.pdf 

Comment: Monsanto plans to effectively commercialize MON 87705 soybean before all 

major markets have completed regulatory approval for legal importation. One soybean 

purchaser that has not granted approval at this point is South Korea, which may become 

an even larger customer for US soybean when the current Free Trade Agreement with 

them is signed. Future soybean trade may be jeopardized if MON 87705 soybean is 

commingled in current shipments and arrives without such approval. The full potential 

costs of products of new technology should be shared between Monsanto and production 

chain partners by agreements made between the parties. 

21 
Response: APHIS understands the importance of obtaining 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 of the 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 already in 

place. Restrictions on international trade in GE products, including MON 87705 Soybean, are 

unlikely to change with a determination of nonregulated status ofMON 87705 Soybean. 

To support commercial introduction ofMON 87705 Soybean in the US., Monsanto has 

indicated in their petition request ofnonregulated status ofMON 87705 Soybean that the 

necessary regulatory submissions will be made by the petitioner to countries that import 

significant quantities of soybean 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 identity preservation 

of high oleic soybean through a closed loop stewardship plan; this comprehensive management 

plan is acceptable to the commenter. Product integrity will be preserved by requirements for 

analysis, standard operating procedures, contracts or agreements, and segregated storage between 

each level of processor and user (Monsanto, 2010). In the EA, APHIS has determined that the 

risk of impact on the soybean-using food industry following wide scale production ofMON 

87705 is not likely to be significant given the management plan offered by Monsanto, 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. 

If some soybean could not be shipped to this country until acceptance of MON 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% of the 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 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. 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 authority to impose further restrictions on MON 87705 Soybean. 

FAPRI (2009). US. and World Agricultural Outlook Food and Agricultural Policy Research 

Institute. 395pp. http://w\vw. tapti. iastate.egu!outiook!2009! 

Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved Fatty Acid 

Profile MON 87705 Soybean. Submitted by G. Rogan. Monsanto Company, St. Louis, 

MO (See Table h!!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 of another representing companies and cooperatives producing and providing services 

to grain and oilseed exporting industry comment that they have concerns for impacts on 

international agriculture if MON 87705 moves outside the closed loop system. While they 

appreciate that the management system proposed by Monsanto will appropriately manage 

the potential for commercial disruptions, they are concerned that Monsanto has not 

publicaUy made "its commitment to corporate responsibility••• to all stakeholders in the 

value chain." 

Response: Monsanto has indicated in their petition requesting nonregulated status for MON 

87705 Soybean that the necessary regulatory submissions will be made by the petitioner to 

countries that import significant quantities ofsoybean or its processed fractions from the U.S. 

(Monsanto, 20 I 0). Regulatory packages will only be submitted to those countries which have 

established regulatory approval processes; notifications will be given those importing countries 

without formal approval systems (Monsanto, 20 I 0). During the time international authorizations 

for soybean are being sought for likely importing countries, Monsanto proposes to grow and 

market this 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 specialty oil seeds supplied tO'processors, Clarkson, 2004)). 

Deployment ofa closed loop system is consistent with the recommendations of soybean 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 of any 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 occurring under 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 of agreements, 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 of events were to occur, 

potential impacts would be expected to be minimal. As Monsanto notes in the Addendum to the 

petition, three quality parameters important to oil users can vary by as much as 14-15% without 

impacts on oil function, sensory properties, labeling requirements, or on oil marketing and uses. 

At the farm level, an exceptionally large number ofmisdirected trucks carrying MON 87705 

23 

soybean 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 of deregulated traits 

in major foreign markets]. American Soybean 

Association. h!.!n:!I~'\:vw.soygrowers.com!issucs!biotechno logy. htm 

Clarkson, L. (2004). Niche oilseeds require identity preservation. Processing Article. 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 by G. 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 of research and 

monitoring may be needed to study impacts on insects, wildlife and birds. 

Response: First observed on the eastern U.S. coast in the second half of 2006, honey bee colony 

collapse disorder (CCD) accounted for a decline of approximately 36 percent of the honey bee 

population (Johnson, 2010). In contrast to other previous bee colony losses, CCD can be 

distinguished by several unusual attributes, including: 1) failure of adult worker bees to return to 

the hive, despite the presence of a brood and queen remaining in the hive; 2) relatively 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 include pathogens, 

parasites, environmental stresses, and bee management stresses (e.g., poor nutrition); however, 

recent evidence suggests that CCD may represent a syndrome caused by a suite of factors 

interacting synergistically to produce rapid and wide-spread colony collapse (USDA, 2009; 

Ratnieks et a1., 20 I 0, Mullin et at, 2010). Potential biotic and abiotic stresses correlated with 

CCD include, but may not be limited to: the single-celled parasite Nosema ceranae; Israeli acute 

paralysis virus (IAPV) and its potential vector, the Varma mite; or neonicotinoids, synthetic 

insecticides that bind the insect nicotinic acetylcholine receptor and other insecticides (Vidau et 

aI., 2011). However, correlation is not the same as causation. While several factors have been 

observed to be strongly correlated with CCD, few hypotheses have been experimentally verified 

and thus it is not currently known with certainty which factors produce CCD. 

As the petitioner noted, APHIS states in the EA that soybeans are mostly self-pollinated; some 

research indicates that different cultivars are visited more or less frequently by honey bees 

(Erickson, 1975). Although foraging honcy bees and brood could potentially come into contact 

with MON 87705 pollen, toxins are not synthesized by the genetic material altered in MON 

87705 soybean. MON 87705 specifically down-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 

24 

expected changes in fatty acid concentration, there were no biologically significant differences 

between MON 87705 Soybean and these other cultivars (FDA, Biotechnology Consultation Note 

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 and the foods and feeds derived 

from it are not materially different in composition, safety, or any other relevant parameter from 

other soybean varieties now grown, marketed, and consumed in the U.S. At this time, based on 

Monsanto's data and information, the agency considers Monsanto's consultation on soybean 

MON 87705 to be complete." 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 in the environment from 

consuming or using MON 87705 as habitat are unlikely, since there are no significant differences 

from the conventional cultivars. 

APHIS evaluated in the EA Monsanto's presentation ofobservations made ofpopulations ofpest 

insects (Monsanto, 2010, Table G-8) and ofbeneficial insects (Monsanto, 2010, Table G-9). 

APHIS concluded that there are no insect population differences between the MON 87705 

Soybean and control plants over multiple field sites. Insect population diversity represents one 

measure of general impacts, and there were no differences observed at various times during 

development ofthe crop. In the absence of any observable acute stresses or impacts, 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 already been 

widely used in many crops over numerous 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 on the use of glyphosate and 

impacts on the environment, and notes that EPA concluded that glyphosate does not provide 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 between MON 87705 and conventional 

soybean, any potential impact ofMON 87705 on the honeybee population or on other wildlife 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=PP 1 &dq=Honey%20bee%20col 

ony<'102 Ocollapse%20disorder&pg=PP 1 #v=onepage&q&f=false. 

Monsanto. (2010) Petition for the Determination ofNonregulated Status for Improved Fatty Acid 

Profile MON 87705 Soybean. Submitted by G. Rogan. Monsanto Company, St. Louis, 

MO (See Table http://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 of Miticides and Agrochemicals in North American Apiaries: 

Implications for Honey Bee Health. PLoS ONE 5:e9754. 

25 
Ratnieks, F.L.W., Carreck, N.L. (2010) Clarity on honeybee collapse? Science 327: 152-153. 

USDA (2009). Colony Collapse Disorder Progress 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 of Fipronil and Thiacloprid Highly Increases Mortality of Honeybees Previously 

Infected by Nosema ceranae. PLoS ONE 6(6): e21550. 

doi: 10.13711joumal.pone.0021550. 

Comment: One comment states that Monsanto 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 plant pest risk to the environment. A person may petition the agency that a 

particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer 

regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 CFR 

340. The petitioner is required to provide information under § 340.6(c)(4) related to plant pest 

risk that the agency may use to determine whether the regulated article is unlikely to present a 

greater plant pest risk than the unmodified organism. There is no regulatory requirement that 

information submitted by petitioners to APHIS must be peer reviewed by a scientific panel. 

In enacting the Plant Protection Act, Congress found that: 

[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under (the Plant Protection Act) shall be based on sound science ... §402(4) (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 of policies for oversight of emerging technologies (such as genetic engineering) 

at the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563 and, consistent with that Executive Order, the following principle, among others, to 

the extent permitted by law, when regulating emerging technologies: 

"[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries ofthe authorities and mandates 

of each agency" 

To assist APHIS in their scientific technical review of a petition request, in accordance with 

APHIS regulatory requirements set forth in 7 CFR part 340, APHIS makes each complete 

petition available for a 60 day public comment period. Petitions submitted by developers are 

announced in a Federal Register Notice and made publicly available on the APHIS website*. 

Petitions submitted by developers are made available to the public 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 

26 

with 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 of new pathogens, and cite the letter to Agriculture 


Secretary Vilsack from retired Professor Don Huber as support for this contention. 


Response: Professor Huber's letter alleges that either the gene to produce glyphosate tolerant 


crops or the use ofglyphosate (Roundup) is either a promoter or cofactor that facilitates a 


pathogen capable ofinfecting a variety ofsoybean, com, their products, various livestock and 


. "probably human beings." The letter claims evidence for the pathogen in electron micrographs 

(which are not published) and alleges animal infertility (anecdotes, none published, with no 

general corroboration), and a claim for escalating frequency 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 wheat product, on which glyphosate may have 

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 of glyphosate has adverse effects on human 

. and animal health, and that a safety review is needed. 

Response: The EA has reported on the safety ofthe use of glyphosate in the environmental 


consequences and cumulative impacts sections under various headings, including those on 


animals, plants, biodiversity, microbes and human health. 


The CP4 EPSPS protein used in MON 87705 Soybean confers tolerance to glyphosate. This 

protein is structurally homologous and similar functionally to endogenous plant EPSPS enzymes 

and is identical to the CP4 EPSPSs in other Rounduj Ready® crops, including Roundup Ready® 

soybean (40-3-2 and MON 89788, Roundup Ready canola, Roundup Ready® sugar beet, 

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 determined by APHIS to be no longer subject to the regulatory 

requirements of7 CFR Part 340 or the plant pest provisions ofthe Plant Protection Act in 1995 

(http://www.aphis.usda.govlbiotechnology/notJeg.html). The cp4 epsps gene has been assessed 

extensively in the last 15 years. The safety ofCP4 EPSPS protein present in biotechnology 

derived crops has been evaluated as part of comprehensive reviews of the safety of glyphosate 

exposure and ingestion (Harrison et at, 1996; see also Hammond et aI., 1996; Padgette et aI., 

1996). The FDA has 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). 

27 

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). This exemption is based on a 

safety assessment that included rapid digestion in simulated gastric fluids, lack of homology to 

known toxins and allergens, and lack of toxicity in an acute oral mouse gavage study. The CP4 

EPSPS protein expressed in MON 87705 Soybean is the same as that previously reviewed by the 

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 of pesticide poisonings and injuries among agricultural workers and 

pesticide handlers. The WPS offers protections to more than two and a half million agricultural 

workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, 

and greenhouses. The WPS contains requirements for pesticide safety training, notification of 

pesticide applications, use of personal protective equipment, restricted entry intervals following 

pesticide application, decontamination supplies, and emergency medical assistance. During 

agricultural production ofsoybean, agricultural workers and pesticide applicators may be 

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 plant pest management in both GE and non-GE 

soybean cultivation, including the use of glyphosate. 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 of soybeans fed to rats, chickens, catfish and 

dairy cattle is not altered by genetic incorporation of glyphosate 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 from Agrobacterium 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 of glyphosate-tolerant soybean seeds is equivalent 

to that of conventional soybeans. The Journal ofNutrition, 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. Federal Register. 

61(150),40338-40340. 

US-FDA. (2011). Biotechnology Consultation - Note to File No. 000121. College Park, MD: 

Department of Health and Human Services, Food and Drug Administration. 

28