NATIONAL ENVIRONMENTAL POLICYACT DECISION AND FINDING OFNO SIGNIFICANT IMPACT

Monsanto Stearidonic Acid MON 87769 Soybean

United States Department ofAgriculture 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 complywiththe requirements ofthe National Environmental PolicyAct (NEPA) of1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementing NEPA, and the USDAAPHIS' NEPAimplementing regulations and procedures. This NEPA decision document, a Finding ofNo Significant Impact (FONSI), sets forth APHIS' NEPA decision and its rationale. Comments from the public involvementprocess were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementingNEPA (7 CFRpart 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 ofa petitionrequest (APHIS Number 09-183-01p) byMonsanto for their transgenic soybean, event MON

·87769 (hereafter referred to as MON 87769 Soybean), that is genetically engineered to express high levels ofthe 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 ofwhichmay beinvolved in promoting heart health and otherphysiologicallyhealthful conditions. These fatty acids maycommonlybe derived from fish oils, but a soybean source containing SDA that provides a precursor to these would bemore efficientlyproduced in human nutrition. This EA has beenprepared in order to specifically evaluate the effects on the quality ofthe human environment1that mayresult 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 "ProtectingAmerican agriculture" is the basic charge ofAPHIS

. APHIS provides leadership in ensuring the health and care ofplants and animals. The agency improves agricultural productivity and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural production (conventional, organic, or the use of

1UnderNEPA regulations, the "human environment" includes "the natural and physical environment and the relationship ofpeople with that environment" (40 CFR §508

. 14)

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

NEPA Decision and Rationale I have carefully reviewed the EAprepared for this NEPA determination and the input from the public involvementprocess. Ibelieve 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 ofgenetically engineered organisms consistent with the plantpestprovisions ofthe Plant Protection Act.

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the agencybelieves would fulfill its statutorymission and responsibilities, giving consideration to economic, environmental, technical and other factors." The preferred alternative has been selected for implementation based on consideration ofa number ofenvironmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) it allows APHIS to fulfill its statutorymission to protect America's agriculture and environment using a science-based regulatory framework that allows for the safe development and use of genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified anyplant pest risks associated with MON 87769 Soybean, the continued regulated status ofMON 87769 Soybean wouldbe inconsistent with the plant pest provisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnology regulatorypolicies 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 DeputyAdministrator BiotechnologyRegulatory Services Animal and Plant Health Inspection Services U.S. Department ofAgriculture Date:



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