### Determination ofNonregulated Status for MonsantoEventMON 87712 Soybean

In response to petition 11-202-01p from Monsanto Company, the Animal and Plant Health Inspection Service (APHIS) ofthe United States Department ofAgriculture (USDA) has determined that Monsanto Event MON 87712 soybean and progeny derived from it are not likely to pose a plantpest risk and are no longer to be considered regulated articles under APHIS's Biotechnology Regulations (Title 7 ofthe Code ofFederal Regulations (CFR), part 340). Since APHIS has determined that Event MON 87712 soybean is unlikely to pose a plant pest risk, APHIS will approve the petition for nonregulated status ofEvent MON 87712 soybean

. Therefore, APHIS approved permits or acknowledged notifications that were previously required for environmental releases, interstate movement, or importation under these regulations will no longer be required for Event MON 87712 soybean and its progeny. Importation ofEvent MON 87712 soybean seeds and other propagative material will still be subject to APHIS foreign quarantine notices at 7 CFR part 319 and Federal Seed Act regulations at 7 CFRpart 201.
This determination for Event MON 87712 soybean is based on APHIS' analyses offield and laboratory data submitted by Monsanto, references provided in the petition, peerreviewed publications, and other relevant information as described in the Plant Pest Risk Assessment (PPRA) for Event MON 87712 soybean.
The Plant Pest Risk Assessment conducted on Event MON 87712 soybean concluded that it is unlikely to pose a plant pest risk and should no longer be subject to the plant pest provisions ofthe Plant Protection Act and 7CFRpart 340 for the following reasons: (1) Disease and insect susceptibility, agronomic performance, and compositional profiles ofEvent MON 87712 soybean are similar to those ofits non
-genetically engineered soybeans counterpaiis and/or other soybean cultivars grown in the U.S., and are unlikely to alter disease and pest susceptibilities; (2) MON 87712 soybean exhibits no characteristics that would cause it to be weedier or more difficult to control as a weed than control soybean or otherpreviously deregulated soybean; (3) Gene introgression from Event MON 87712 soybean into wild relatives in the United States and its territories is extremely unlikely and is not likely to increase the weediness potential ofany resulting progeny nor adversely affect the genetic diversity ofrelated plants any more than would cultivation oftraditional or other specialty soybean varieties; (4) Based on an evaluation ofthe gene products and testing ofrepresentative non-target species, it has been concluded that MON 87712 soybean is unlikely to adversely affect nontarget organisms, including those considered beneficial; (5) Horizontal gene transfer is unlikely to occur between EventMON 87712 soybean and organisms with which they cannot interbreed; (6) No changes to agricultural or cultivation practices are expected and thus, no changes to plant pest risks are expected due agriculture or cultivadon.
In addition to our finding that Event MON 87712 soybean is not likely to pose a plant pest risk, APHIS has completed an Environmental Assessment (EA) and a Finding ofNo Significant Impact (FONSI) for this action and has determined that a determination of nonregulated status ofEvent MON 87712 soybean and its progeny would have no

1significant impacts, individually or collectively, on the quality ofthe human environment and will have no effect on federally listed threatened or endangered species, species proposed for listing, or their designated orproposed critical habitats (http:/ /www.aphis.usda.gov/biotechnology/not reg.html). APHIS also concludes, based upon its PPRA, that new varieties derived from Event MON 87712 soybean are unlikely to exhibit new properties that are substantially different from the ones observed for Event MON 87712 soybean, or those observed for other soybean varieties not considered regulated articles under 7 CFRpart 340, that would pose a plant pest risk.
Based on my full and complete review and consideration ofall ofthe scientific and environmental data, analyses, information, and conclusions ofthe PPRA, the Final EA, the agency's Response to Public Comments received in reference to the Draft EA, the FONSI, and my knowledge and experience as the Deputy Administrator ofAPHIS Biotechnology Regulatory Services, I have determined and decided that this determination ofnon-regulated status for Event MON 87712 soybean is the most scientifically sound and appropriate regulatory decision.

Michael J. Deputy Administrator, Acting Biotechnology Regulatory Services Animal and Plant Health Inspection Service U.S. Department ofAgriculture

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