Preliminary Determination1 of Nonregulated Status for Monsanto Event MON 

87427 corn

In response to petition 10-281-01p from Monsanto, The Animal and Plant Health 

Inspection Service (APHIS) of the United States Department of Agriculture (USDA) has 

determined that Monsanto Event MON 87427 corn 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’s Biotechnology Regulations (Title 7 of the Code of Federal Regulations (CFR), 

part 340). Since APHIS has determined that Event MON 87427 corn is unlikely to pose 

a plant pest risk, APHIS will approve the petition for nonregulated status of Event MON 

87427 corn. Therefore, APHIS approved permits or acknowledged notifications that were 

previously required for environmental releases, interstate movement, or importation 

under these regulations will no longer be required for Event MON 87427 corn and its 

progeny. Importation of Event MON 87427 corn 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 for Event MON 87427 corn is based on APHIS’ analyses 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 Event MON 87427 corn.

The Plant Pest Risk Assessment conducted on Event MON 87427 corn concluded that it 

is unlikely to pose a plant pest risk and should no longer be subject to the plant pest 

provisions of the Plant Protection Act and 7CFR part 340 for the following reasons: 

(1) MON 87427 is not significantly different from its comparator or commercial 

varieties. There is no indication that MON 87427 possesses a selective advantage that 

would result in increased weediness. MON 87427, as other corns, lacks the ability to 

persist as a troublesome weed, and there would be no significant impact on current weed 

management practices for corn cultivation; (2) APHIS evaluated the potential for gene 

introgression to occur from MON 87427 to sexually compatible wild relatives (teosinte 

and to a lesser extend with Tripsacum) and considered outcrossing of MON 87427 not 

expected to be any different from other corn varieties. Therefore, USDA has determined 

that any adverse consequences of gene flow from MON 87427 to wild or weedy species 

in the U.S. are highly unlikely; (3) APHIS assessed whether horizontal gene transfer 

might occur between MON 87427 corn and inserted genes with other organisms. Also, 

the FDA has evaluated horizontal gene transfer following plant transformation with 

antibiotic resistance marker genes, and concluded that the likelihood of transfer of these

genes from plant genomes to microorganisms in the gastrointestinal tract of humans or 

animals, or in the environment, is remote. Therefore, APHIS also concludes that 

horizontal gene transfer is unlikely to occur and thus poses no significant environmental 

or plant pest risk; (4) Corn is not a plant pest in the United States, and the introduced 

DNA in MON 87427 is unlikely to pose a plant pest risk. Based on the review of 

numerous field tests with MON 87427 provided by the petitioner, and the analysis of 

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genetic modifications and their functions, APHIS concludes that there are no significant 

differences between MON 87427 corn and the non-transgenic counterparts relative to

pest and disease susceptibility.

In addition to our finding that Event MON 87427 corn 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 Event MON 87427 corn 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 Event MON 87427 corn are unlikely to 

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

MON 87427 corn, or those observed for other corn 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 non-regulated status 

for Event MON 87427 corn is the most scientifically sound and appropriate regulatory 

decision. 

___________________________________

Michael Gregoire

Deputy Administrator

Biotechnology Regulatory Services

Animal and Plant Health Inspection Service

U.S. Department of Agriculture

Date: 

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