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Determination of nonregulated status for Pioneer DP-305423-1 soybean

In response to petition 06-354-01p from Pioneer Hi-Bred, APHIS has determined that 

Pioneer 305423 soybean and progeny derived from it are unlikely to pose a plant pest risk 

and are no longer to be considered regulated articles under APHIS’s biotechnology

regulations at 7 CFR part 340, as APHIS has no authority to continue to regulate a GE 

organism once APHIS has determined that the GE organism is not likely to pose a plant 

pest risk. Permits or acknowledged notifications that were previously required for 

environmental release, interstate movement, or importation under those regulations are no 

longer a requirement for Pioneer High Oleic Event 305423 soybean and its progeny. 

Importation of 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 is based on APHIS’ analysis of field, greenhouse, and laboratory data, 

references provided in the petition, and other relevant information as described in the 

Plant Pest Risk Assessment for Event 305423 soybean, the Environmental Assessment 

and in APHIS’s response to public comments that indicate that Event 305423 soybean is 

unlikely to pose a plant pest risk. 

The Plant Pest Risk Assessment (http://www.aphis.usda.gov/brs/not_reg.html) concluded 

that Pioneer High Oleic 305423 soybean is not likely to pose a plant pest risk and should 

be granted nonregulated status for the following reasons: (1) agronomic performance, 

disease and insect susceptibility, and compositional profiles (except for the intended 

changes in the fatty acid profile) of Event 305423 soybean are similar to those of its nongenetically engineered soybean counterparts and/or other soybean cultivars grown in the 

U.S., and are unlikely to have direct or indirect plant pest effects on raw or processed 

plant commodities; (2) the new gene products cause no greater changes to plant 

metabolism or seed composition (except for the intended changes in the fatty acid profile)

than conventional soybean; (3) gene introgression from Event 305423 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 plant any more than would cultivation of traditional or other specialty 

soybean varieties; (4) it exhibits no characteristics that would cause it to be weedier or 

more difficult to control as a weed than the non-genetically engineered parent soybean 

line or any other cultivated soybean; and (5) horizontal gene transfer is unlikely to occur 

between Event 305423 soybean and soil bacteria.

In addition, APHIS has completed an Environmental Assessment (EA) for this action and 

has determined that granting nonregulated status to Event 305423 soybean and its 

progeny would have no significant impact, individually or cumulatively, 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 

habitat (http://www.aphis.usda.gov/brs/not_reg.html). APHIS also concludes that new 

varieties bred from Event 305423 soybean are unlikely to exhibit new plant pest 

properties, i.e., properties substantially different from any observed for Event 305423, or 
those observed for other soybean varieties not considered regulated articles under 7 CFR 

part 340. 

JUN 7 2010 


.-fdr Michael C. Gregoire Date 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department ofAgriculture