NATIONAL ENVIRONMENTAL POLICY ACT DECISION 

AND 

FINDING OF NO SIGNIFICANT IMPACT 

Monsanto 

Stearidonic Acid MON 87769 Soybean 

United States Department of Agriculture 

Animal and Plant Health Inspection Service 

Biotechnology Regulatory Services 

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection 

Service (APHIS) has developed this decision document to comply with the requirements of the 

National Environmental Policy Act (NEPA) of1969, as amended, the Council ofEnvironmental 

Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing 

regulations and procedures. This NEP A decision document, a Finding of No 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 ifthere are any 

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

status of a petition request (APHIS Number 09-183-01p) by Monsanto for their transgenic 

soybean, event MON·87769 (hereafter referred to as MON 87769 Soybean), that is genetically 

engineered to express high levels of the fatty acid stearidonic acid (SDA) in soybean seed. MON 

87769 Soybean is a specialty trait soybean characterized by a fatty acid profile containing SDA, 

an omega-3 fatty acid, which is not found in conventional soybean (Monsanto, 2010b). SDA (an 

18-carbon fatty acid with four double bonds or 18:4) is metabolically converted in humans to 

eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6), both ofwhich may 

be involved in promoting heart health and other physiologically healthful conditions. These fatty 

acids may commonly be derived from fish oils, but a soybean source containing SDA that 

provides a precursor to these would be more efficiently produced in human nutrition. This EA 

has been prepared in order to specifically evaluate the effects on the quality of the human 

environment1 that may result from a determination ofnonregulated status ofMON 87769 

Soybean. The EA assesses alternatives to a determination ofnonregulated status ofMON 87769 

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 of APHIS. APHIS provides leadership in 

ensuring the health and care of plants and animals. The agency improves agricultural 

productivity and competitiveness, and contributes to the national economy and the public health. 

USDA asserts that all methods of agricultural production (conventional, organic, or the use of 

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

relationship ofpeople with that environment" (40 CFR §508.14). 

1 
EPA. There are no other Federal, state, or local permits that are needed prior to the 

implementation of this action. 

NEP A Decision and Rationale 

I have carefully reviewed the EA prepared for this NEP A determination and the input from the 

public involvement process. I believe that the issues identified in the EA are best addressed by 

selecting Alternative 2 (Determination that MON 87769 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 of the 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 87769 Soybean, the 

continued regulated status ofMON 87769 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 

determined that a determination ofnonregulated status ofMON 87769 Soybean will not have 

any significant environmental effects. 

Michael C Gregoire 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Services 

U.S. Department of Agriculture 

Date: 

20