Determination of Nonregulated Status for 

Monsanto Company MON 87708 Soybean 

In response to petition 10-188-01p from Monsanto Company (hereinafter referred to as 

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

Department of Agriculture (USDA) has determined that Monsanto dicamba herbicideresistant MON 87708 soybean (hereinafter referred to as MON 87708 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' Biotechnology Regulations at Title 7 of the 

Code of Federal Regulations, part 340 (7 CFR part 340). Since APHIS has determined 

that MON 87708 soybean is unlikely to pose a plant pest risk, APHIS will approve the 

petition for nonregulated status of MON 87708 soybean. Therefore, APHIS approved 

permits or acknowledged notifications that were previously required for environmental 

release, interstate movement, or importation under these regulations will no longer be 

required for MON 87708 soybean and its progeny. Importation of MON 87708 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 parts 201 and 361. 

This Determination of nonregulated status for MON 87708 soybean is based on APHIS' 

analyses of field 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 87708 soybean. 

The PPRA conducted on MON 87708 soybean concluded that it is unlikely to pose a 

plant pest risk and should no longer be subject to the regulations at 7 CFR part 340 for 

the following reasons: 

(1) No plant pest risk was identified from the transformation process, the insertion 

and/or expression of new genetic material, or from changes in metabolism in 

MON 87708 soybean. 

(2) Disease and pest incidence and/or damage were not observed to be significantly 

increased or atypical in MON 87708 soybean compared to the nontransgenic 

counterpart or other comparators in field trials conducted in growing regions 

representative of where MON 87708 soybean is expected to be grown. Observed 

agronomic traits also did not reveal any significant differences that would 

indirectly indicate that MON 87708 soybean is more susceptible to pests or 

diseases. Therefore no plant pest effects are expected on these or other 

agricultural products and no impacts are expected to APHIS pest control 

programs. 
(3) Based on an evaluation of the gene products, donor organisms, chemical 

composition, environmental interactions with beneficial arthropods, pollen 

characteristics and association with symbionts, exposure to and/or consumption of 

MON 87708 soybean are unlikely to adversely impact nontarget organisms 

beneficial to agriculture. 

(4) MON 87708 soybean is no more likely to become weedier or more difficult to 

control as a weed than conventional varieties of this crop based on its observed 

agronomic characteristics, weediness potential of the crop and current 

management practices available to control MON 87708 soybean as a weed. 

(5) MON 87708 soybean is not likely to increase the weed risk potential of other 

species with which it can interbreed in the U.S. or its territories. Gene flow, 

hybridization and/or introgression of inserted genes from MON 87708 soybean to 

other sexually compatible relatives with which it can interbreed is not likely to 

occur. 

(6) Significant changes to agricultural or cultivation practices (e.g. pesticide 

applications, tillage, irrigation, harvesting, etc.) from adoption of MON 87708 

soybean are expected, but are not likely to increase plant diseases or pests or 

compromise their management. 

(7) Horizontal gene transfer of the new genetic material inserted into the GE plant to 

other organisms is highly unlikely ;and is not expected to lead directly or 

indirectly to disease, damage, injury or harm to plants, including the creation of 

new or more virulent pests, pathogens, or parasitic plants. 

APHIS also concludes in its PPRA that new varieties derived from MON 87708 soybean 

are unlikely to exhibit new properties substantially different from the ones observed for 

MON 87708 soybean, or those observed in other soybean varieties not considered 

regulated articles under 7 CFR part 340, that would pose a plant pest risk. 

Prior to this Determination of nonregulated status, APHIS completed a Final 

Environmental Impact Statement (FEIS) which explored the potential environmental 

impacts that a determination of nonregulated status for MON 87708 soybean and its 

progeny would have on the quality of the human environment. The FEIS concluded, 

among other things, that a determination of nonregulated status for MON 87708 soybean 

and its progeny will have no effect on federally-listed threatened and endangered species, 

species proposed for listing, or their designated or proposed critical habitats. APHIS also 

concludes with its Determination of nonregulated status, based upon its PPRA, and 

informed by the completion of the FEIS and the Record of Decision that was issued for 

the FEIS, that new varieties derived from MON 87708 soybean are unlikely to exhibit 

new properties substantially different from the ones observed for MON 87708 soybean, 

or those observed for other soybean varieties not considered regulated articles under 7 

CFR part 340, that would pose a plant pest risk. 

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

environmental data, analyses and information, the input from the public involvement 

process, the conclusions of the PPRA, the FEIS and its Record of Decision, and my 

knowledge and experience as the APHIS Deputy Administrator for Biotechnology 

Regulatory Services, I have determined and decided that this Determination of 

nonregulated status for MON 87708 soybean is the most scientifically sound and 

appropriate regulatory decision. 

~ ' . ~ ~ ~ ~ ~ ✓<~~ ~~ ~ ~ ~ 

~ 

Michael J. Firko, Ph.D. Date 

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture