Determination of Nonregulated Status for Monsanto Event MON 87712 Soybean 

In response to petition 11-202-01 p from Monsanto Company, the Animal and Plant 

Health Inspection Service (APHIS) of the United States Department of Agriculture 

(USDA) has determined that Monsanto Event MON 87712 soybean and progeny derived 

from it are not likely to pose a plant pest risk and are no longer to be considered regulated 

articles under APHIS's Biotechnology Regulations (Title 7 of the Code of Federal 

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 of Event 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 of Event 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 CFR part 201. 

This determination for Event MON 87712 soybean is based on APHIS' analyses of field 

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 of the Plant Protection Act and 7CFR part 340 for the following reasons: 

(1) Disease and insect susceptibility, agronomic performance, and compositional profiles 

of Event MON 87712 soybean are similar to those of its 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 other previously 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 of any resulting 

progeny nor adversely affect the genetic diversity of related plants any more than would 

cultivation of traditional or other specialty soybean varieties; (4) Based on an evaluation 

of the gene products and testing of representative 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 Event MON 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, AP HIS has completed an Environmental Assessment (EA) and a Finding of No 

Significant Impact (FONSI) for this action and has determined that a determination of 

nonregulated status of Event MON 87712 soybean and its progeny would have no 

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significant impacts, individually or collectively, on the quality of the human environment 

and will have no effect on federally 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). 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 CFR part 340, that would pose a plant pest risk. 

Based on my full and complete review and consideration of all of the scientific and 

environmental data, analyses, information, and conclusions of the 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 of APHIS 

Biotechnology Regulatory Services, I have determined and decided that this 

determination of non-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 of Agriculture 

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