Preliminary 1

Determination of Nonregulated Status of 73496 Canola (Brassica 

napus)

In response to petition 11-063-01p from Pioneer Hi-Bred International, Inc. (hereafter referred to 

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

Department of Agriculture (USDA) has determined that 73496 canola and progeny derived from 

it are unlikely to pose a plant pest risk and are no longer to be considered regulated articles under 

APHIS' Biotechnology Regulations in Title 7 of the Code of Federal Regulations, part 340 (7 

CFR part 340). Since APHIS has determined that 73496 canola is unlikely to pose a plant pest 

risk, APHIS will approve the petition for nonregulated status of 73496 canola. 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 73496 canola and its progeny. Importation of 73496 canola 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 of nonregulated status of 73496 canola is based on APHIS' assessment of 

field and laboratory data submitted by Pioneer, references provided in the petition, peer-reviewed 

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

(PPRA) for 73496 canola (including its progeny). Based on the above-mentioned assessment, 

APHIS concludes the following:

a. The introduced synthetic gat4621gene encoding the glyphosate N-acetyltransferase 

enzyme GAT4621 in 73496 canola results in the detoxification of applied glyphosate 

herbicide; neither the introduced sequences nor the method of transformation has resulted 

in disease symptoms, pathogen infection, or expression of a pathogen in 73496 canola. 

b. Changes in gene expression, enzymes or metabolism in 73496 canola are unlikely to pose 

a plant pest risk; minor differences in the compositional constituents of 73496 canola

seed compared to the control canola that could directly or indirectly impact plant pests or 

plant health were well within the range of commercial reference varieties, and did not 

raise any plant pest risks.

c. The observed insect pests and diseases or resulting damage on 73496 canola compared to 

the control canola suggest that 73496 canola is unlikely to be more susceptible to 

pathogens and insect pests of conventional canola or to bring about indirect plant pest 

effects on other agricultural products.

d. Based on the toxicity and safety assessment of the GAT4621 enzyme and minor changes

in canola seed composition, 73496 canola is unlikely to adversely impact wildlife or other 

organisms beneficial to agriculture any more than conventional canola varieties.

e. There were no meaningful observed differences in traits between 73496 canola and 

control canola that would (i) enhance weediness in canola, or (ii) enhance its gene flow 

potential to wild or weedy relatives and consequently increase weedy characteristics in 

wild or weedy relatives. Furthermore alternative herbicides are available to control 

glyphosate resistant canola and weedy relatives.

1 Determination is not effective until officially signed and posted. Page 1
f. The glyphosate resistance trait and observed agronomic and pest response characteristics 

in 73496 canola are not expected to change agricultural or cultivation practices compared 

to those currently used in widely-cultivated glyphosate-resistant canola varieties, which

experience has shown has not increased pests or diseases or impacted their control. 

g. Genes encoding variants of the GAT4621 protein already exist in a widespread, nonpathogenic soil bacterium in the environment, and horizontal transfer of the inserted 

glyphosate resistance gene from 73496 canola to other organisms with which it cannot 

interbreed is highly unlikely, and thus should not pose a plant pest risk. 

In addition to our finding that 73496 canola is unlikely to pose a plant pest risk, APHIS has 

completed an Environmental Assessment (EA) and preliminary Finding of No Significant Impact 

(FONSI) for this action and has determined that a determination of nonregulated status of 73496

canola 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.gov/biotechnology/not_reg.html). APHIS also concludes, based upon 

its PPRA, that new varieties derived from 73496 canola are unlikely to exhibit new properties 

that are substantially different from the ones observed for 73496 canola, or those observed for 

other canola varieties not considered regulated articles under 7 CFR part 340, that would pose a 

plant pest risk.

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

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

conclusions of the PPRA, the EA, and the preliminary 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 73496 canola 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

1 Determination is not effective until officially signed and posted. Page 2