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**Extended Determination of Nonregulated Status for**  **MON 87751 Soy (**  **Glycine max )**  In response to a request to extend a determination of nonregulated status to lepidopteran resistant soy

event MON 87751 ( 13

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- 01p ) from Monsanto Company (hereafter referred to as Monsanto ), the Animal and Plant Health Inspection Service (APHI S) of the United States Department of Agriculture (USDA) has determined that MON 87751 soy and progeny derived from it are unlikely to pose plant pest risks and are n o longer to be considered regulated article s under APHI S'Biotechnology Regulations (Title 7 of Code of Federal Regulations (CFR), part 340). This extension request is based upon APHI S’ determination of nonregulated status of Monsanto event MON 87701 (APH IS petition # 09

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- 01p, effective October 12, 2011). Since APHI S has determined that MON 87751 soy is unlikely

to pose a plant pest risk, APHI S will approve the request to extend the determination of nonregulated status to MON 87751 soy . Therefore, APHIS

- approved permits or acknowledged notifications that were previously required for environmental release, interstate movement, or importation under those regulations will no longer be required for MON 87751 soy and its progeny . Importation of MON 8775 1 soy seeds and other propagative material would still be subject to APHI S foreign quarantine notices at 7 CFR part 319 and the Federal Seed Act regulations at 7 CFR part 201. MON 87 7 51 has been engineered to express two Bacillus thuringiensis proteins ( Cry 1A.105 and Cry2Ab2) that confer resistance to certain lepidopteran pests of soy beans. APHIS evaluated the plant pest risk of MON 87751 b ased upon its similarity to the previously

deregulated antecedent soy bean , MON 87701, which expresses the Bt protein Cry 1Ac

. Both MON87751 and MON87701 are resistant to the velvetbean caterpillar, soy bean looper, so yb ean axil borer, and sunflower looper, but MON 87751 also includes resistance to fall armyworm. APHI S has concluded that this difference in activity spec tra is unlikely

to affect the plant pest risk of MON 87751. APHI S has previously assessed the risks of the two proteins when expressed in corn (both Cry 1A.105 and Cry2Ab2 ; APHI S Petition Number 06

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- 01p ) and cotton (Cry2Ab2 ; APHIS Petition Number 00

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- 01p ) and concluded that the organisms did not pose a plant pest risk. Furthermore, EPA has reviewed the safety of Cry1A.105 and Cry2Ab2 in corn and concluded that “adverse effects will not occur to nontarget organisms. ” This evidence together suggests th at Cry 1A.105 and Cry2Ab2 in MON 87751 are unlikel y to pose a plant pest risk; nor is MON 87751 likely to pose a different plant pest risk than MON87701. APHI S conducted a Plant Pest Risk Assessment on the antecedent organism , MON 87701 soy
. Based on a comparative review of Monsanto ’s request to extend nonregulated status to MON 87751 , APHI S concludes that MON 87751 is unlikely to pose a plant pest risk and should no longer be subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340
. Based upon the similarity of MON 87751 to MON 87701 : (1) disease and insect susceptibility of MON 87751 should be similar to that of its non

- genetically engineered cotton counterpart , the antecedent organism, and/or other cotton cultivars grown in the U

. S

. ; (2) Like the antecedent organism, gene flow and2

introgression from MON 87751 soy into wild relatives in the United States and its territories is unlikely to occur and genetic diversity of related plants is unlikely to be adversel y affected any more so than might occur with cultivation of traditional or other cotton varieties; (3) MON 87751 soy will exhibit no characteristics that would cause it to be weedier or more difficult to control as a weed than non

- genetically engineered c otton , the antecedent organism or any other cultivated cotton ; (4 ) th e plant and its gene products will not pose a risk to non

- target organisms, including beneficial organisms; ( 5 ) horizontal gene transfer between MON 87751 soy and organisms with which it cannot interbreed is unlikel y to occur. In addition to our finding that MON 87751 soy is unlikely to pose a plant pest risk, APHI S has made a Finding of No Significant Impact (FONSI) for thi s action based on its similarity to MON 87701 soy and the Environmental As sessment completed for the petition submitted fo r that product (APHIS petition number 09

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- 01 p). The progeny of MON 87751 soy would have no significant impacts, individually or collectively , on the quality of the human environment and will have no effect on federall y listed threatened or endangered species, species proposed for listing, or their designated or proposed critical habitats (http://www.aphis.usda.gov/biotechnology/not_reg.html ). Similar to APHI S’ plant pest risk assessment conclusions regarding MON 87701 soy , APHI S concludes that new varieties derived from MON 87751 soy are unlikely to exhibit plant pest properties that are substantiall y different from the ones observed for o ther soy varieties not considered regulated articles under 7 CFR part 340. Based on my review and consideration of all of the scientific and environmental data, anal ys es, information, and previous conclusions regarding the plant pest risk assessment for the antecedent organism MON 87701 soy the FONSI that was prepared based upon the previous NEPA review completed for MON 87701 soy , and my knowledge and experience as the Deputy Administrator of APHI S Biotechnology Regulatory

Services, I have determined and decided that this determination of nonregulated status of MON 87751 soy is the most scientifically sound and appropriate regulatory decision.

_____________________________
__________________________ Michael J. Firko Date Deputy Administrator Biotechnology

Regulatory

Services Animal and Plant Health Inspection Service U.S. Department of Agriculture