Preliminary1 Determination of Nonregulated Status of MON 88302 Canola

(Brassica napus)

In response to petition 11-188-01p from Monsanto Company (hereafter referred to as Monsanto), 

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

Agriculture (USDA) has determined that MON 88302 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 MON 88302 canola is unlikely to pose a plant 

pest risk, APHIS will approve the petition for nonregulated status of MON 88302 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 MON 88302 canola and its progeny. Importation of MON 88302 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 MON 88302 canola is based on APHIS' assessment

of field and laboratory data submitted by Monsanto, references provided in the petition, peerreviewed publications, and other relevant information as described in the Plant Pest Risk 

Assessment (PPRA) for MON 88302 canola (including its progeny). Based on the abovementioned assessment, APHIS concludes the following:

a. Neither the introduced sequences nor the method of transformation has resulted in disease 

symptoms, pathogen infection, or expression of a pathogen in MON 88302. 

b. Composition of Mon 88302 seed is similar to that of the conventional control and/or 

within the natural variability of commercial reference varieties. Therefore, changes in 

gene expression, enzymes or metabolism from introduced genes in MON 88302 are 

unlikely to pose a plant pest risk.

c. MON 88302 is unlikely to be more susceptible to the same plant pathogens and insect 

pests as conventional canola and it is unlikely to bring about any indirect plant pest 

effects on other agricultural products. 

d. MON 88302 is not expected to adversely impact wildlife or other organisms beneficial to 

agriculture any more than conventional canola varieties. 

e. Introduced genes in MON 88302 did not significantly alter any major characteristics of 

the plant that would facilitate the development of weedy characteristics in the crop or 

enhance its gene flow potential to wild or weedy relatives and consequently produce or 

alter characteristics associated with weediness. Furthermore, alternative herbicides are 

available to control glyphosate resistant canola and weedy relatives.

f. The glyphosate resistance trait in MON 88302 and the anticipated changes in agricultural 

practices related to glyphosate resistance in MON 88302 are not expected to increase 

pests or diseases or impact their control in canola or other crops based on prior 

experience with previously deregulated glyphosate resistant canola. 

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g. Genes encoding variants of the EPSPS protein already exist among pathogens and 

symbionts in the environment, and horizontal transfer of the inserted glyphosate 

resistance gene from MON 88302 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 MON 88302 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 

MON 88302 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 MON 88302 canola are 

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

MON 88302 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 MON 88302 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

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