Determination of Nonregulated Status for Monsanto MON 87701 


soybeans 


In response to petition 09-082-01 p from Monsanto Company, the Animal and Plant Health 

Inspection Service (APHIS) of the United States Department of Agriculture (USDA) has 

determined that event MON 87701 soybean and progeny derived from it are unlikely to 

pose plant pest risks and are no longer to be considered regulated articles under APHIS' 

Biotechnology Regulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). 

Since APHIS has determined that MON 87701 soybeans are unlikely to pose plant pest 

risks, APHIS will approve the petition for nonregulated status ofMON 87701 soybeans. 

Therefore, APHIS approved permits or acknowledged notifications that were previously 

required for environmental release, importation, or interstate movement under those 

regulations will no longer be required for event MON 87701 soybeans and its progeny. 

Importation ofMON 87701 soybeans seeds and other propagative material would still be 

subject to APHIS foreign quarantine notices at 7 CFR part 319 and the Federal Seed Act 

regulations at 7 CFR part 201. 

This determination for MON 87701 is based on APHIS' analysis offield, greenhouse and 

laboratory data submitted by Monsanto, references provided in the petition, peer-reviewed 

publications, and other relevant information as described in the Plant Pest Risk Assessment 

(PPRA) for MON 87701. 

The Plant Pest Risk Assessment conducted on MON 87701 concluded that it is unlikely to 

pose plant pest risks and should no longer be subject to the plant pest provisions of the 

Plant Protection Act and 7 CFR part 340 for the following reasons: (1) it exhibits no 

characteristics that would cause it to be weedier than the non-geneticaUy engineered parent 

soybean line or any other cultivated soybeans; (2) gene introgression from event MON 

87701 soybeans 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 genetic diversity of related plants any more than would introgression from 

traditional soybean varieties; (3) horizontal gene transfer is unlikely to occur between 

MON 87701 soybeans and organisms with which it cannot interbreed; (4) disease and 

insect susceptibilities are similar to other soybean cultivars grown in the U.S. ; (5) it does 

not pose a risk to non-target organisms, including beneficial organisms, and (6) 

compositional profiles ofMON 87701 soybeans are similar to those of its parent line and 

other soybean cultivars grown in the U.S, therefore no direct or indirect plant pest effects 

on raw or processed plant commodities are expected. 

In addition to our finding that event MON 87701 is unlikely to pose a plant pest risk, 

APHIS has completed a Final Environmental Assessment (EA) and FONS! for this action 

and has determined that a determination ofnonregulated status for MON 87701 and its 

progeny would have no 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.govlbrsinotreg.htm!). APHJS also concludes in its PPRA 

that new varieties derived from MON 87701 are unlikely to exhibit new plant pest 

properties that are substantially different from the ones observed for MON 87701 

soybeans, or those observed for other soybean varieties not considered regulated articles 

under 7 CFR part 340. 

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

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

nonregulated status of MON 87701 soybeans is the most scientifically sound and 

appropriate regulatory decision. 

Michael C. Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture