Determination of Nonregulated Status for MON 87705 Soybean 

In response to petition 09-201-01p from Monsanto Company (hereafter referred to as 

Monsanto), the Animal and Plant Health Inspection Service (APHIS) ofthe United States 

Department of Agriculture (USDA) has determined that MON 87705 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 

of Federal Regulations (CFR), part 340). Since APHIS has determined that MON 87705 

soybean is unlikely to pose a plant pest risk, APHIS will approve the petition for 

nonregulated status ofMON 87705 soybean. 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 87705 soybean and its progeny. Importation of MON 87705 soybean 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 detennination for MON 87705 soybean is bascd on APHIS' analyses of field and 

laboratory data submitted by Monsanto, references provided in the petition, peerreviewed pUblications, and other relevant information as desclibed in the Plant Pest Risk 

Assessment (PPRA) for MON 87705 soybean. 

The Plant Pest Risk Assessment conducted on MON 87705 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 7 CFR part 340 for the following reasons: (1) 

agronomic performance and disease and pest susceptibility ofMON 87705 soybean is 

similar to that of its non-genetically engineered soybean counterparts andlor other 

soybean cultivars grown in the U.S.; (2) the new gene products are not known to cause 

greater changes to the plant metabolism or seed composition (except for the intended 

changes in the fatty acid profile than conventional soybean; (3) gene introgression from 

MON 87705 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) they exhibit no 

characteristics that would cause them to be wcedier or more diflicult to control as weeds 

than non-genetically engineered soybean or any other cultivated soybean; (5) horizontal 

gene transfer is unlikcly to occur between MON 87705 soybean and organisms with 

which they cannot interbreed. 

In addition to our finding that MON 87705 soybean is unlikely to pose a plant pest risk, 

APHIS has completed a Final Environmental Assessment (EA) and Finding of No 

Significant Impact (FONSn for this action and has determined that a detelmination of 

nonregulated status for MON 87705 soybean and its progeny would have no significant 

impacts, individually or collectively, on the quality of the human environment and will 

have no eifect on federally listed threatened or endangered species, species proposed for 

listing, or their designated or proposed critical habitats 

1 
(http://wvvw.aphis.usda.f!ovbiotechnolof!vinotreg.html). APHIS also concludes in its 

PPRA that new varieties delived from MON 87705 soybean are unlikely to exhibit new 

plant pest properties that are substantially different from the ones observed for MON 

87705 soybean, or those observed for other soybean varieties not considered regulated 

articles under 7 CFR part 340. 

Based on my fiJII 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 

FONS}, and my knO\v1edge and experience as the Deputy Administrator of APHIS 

Biotechnology Regulatory Services, I have detemlined and decided that this 

detell1inatiol1 ofnonregulated status for MON 87705 soybean is the most scientifically 

sound and appropriate regulatory decision. 

Michael C. Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

US. Department of Agriculture 

2