1 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 l onger to be considered regulated articles under APHIS ’s biotechnology regulations at 7 CFR part 340 , as APHIS has no authority to con tinue to regulate a GE organism once APHIS has determined that the GE organism is not likely to pose a plant pest risk. Pe rmits 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 o f seeds and other propagative material w ill 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 dat a, references provided in the petition, and other relevant information as described in the Plant Pest Risk Assessment for Event 305423 soybean, th e E nvironmental A ssessment 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 A ssessment ( 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 a re similar to those of its non

genetically 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 ca use 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 territor ies 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 Eve nt 305423 soybean and soil bacteria.

In addition

, APHIS has completed an Environmental Assessment (EA) for this action and
has determined that grant ing nonregulated status to Event 305423 soybean and its

progeny would have no significant impact , individua lly 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 Ev ent 305423, orthose 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 of Agriculture