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May 30, 2017 5:00 pm

Comments Deadline: Preliminary Decision for an Extension of a Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium Resistance

  • Agency
  • Genetics/Genomics

We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of InVigor® MS8 canola (hereinafter MS8 canola) to Bayer's canola event MS11 in response to a request from Bayer CropScience LP. MS11 canola has been genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium using the same mechanism of action as MS8 canola. We are making available for public comment our draft environmental assessment, preliminary regulatory determination, preliminary finding of no significant impact, and plant pest risk similarity assessment for the proposed determination of nonregulated status.

On March 31, 1999,[1] APHIS announced its determination of nonregulated status of MS8 canola (Brassica napus L.), which was genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium. APHIS has received a request for an extension of that determination of nonregulated status of MS8 canola to canola designated as canola event MS11 (APHIS Petition Number 16-235-01p) from Bayer CropScience LP. (Bayer) of Research Triangle Park, NC. MS11 canola expresses male sterility and resistance to the herbicide glufosinate-ammonium. In its request, Bayer stated that this canola is similar to the antecedent organism MS8 canola and, based on the similarity to the antecedent organism, is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the extension request, MS11 canola was developed using the gene cassette pTCO113 containing the same genetic events used to transform MS8 canola (gene cassette pTHW107) with male sterility and resistance to glufosinate-ammonium. Based on the information in the request, we have concluded that MS11 canola is similar to MS8 canola. MS11 canola is currently regulated under 7 CFR part 340.

More information is available via the Federal Register notice.