(
http://www.regulations.gov)
On July 26, 2013,
Regulations.gov posted a notice advising the public that the Animal and Plant Health Inspection Service (APHIS) has prepared a preliminary determination regarding a petition from GENECTIVE SA, seeking a determination of nonregulated status of maize designated as VCO-01981-5, which has been genetically engineered for resistance to the herbicide, glyphosate. They have also made available for public review their plant pest risk assessment (PPRA), environmental assessment (EA), and preliminary finding of no significant impact (FONSI) for the preliminary determination of nonregulated status.
The notice states that 7 CFR part 340, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests," of the Plant Protection Act regulates, among other things, the introduction of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests.
The notice then goes on to state how APHIS has received a petition from GENECTIVE SA to determine the status of their GE maize, VCO-01981-5, as nonregulated. The petition states that the maize is unlikely to pose a plant pest risk and should therefore not be a regulated article under APHIS' regulations in 7 CFR part 340.
In a notice published in the Federal Register on July 13, 2012, APHIS accepted public comments on the petition for a period of 60 days, ending on September 11, 2012. During that time, APHIS received 79 comments on the petition. Issues raised during the comment period include outcrossing and cross-pollination concerns and effects of herbicide use, such as the development of herbicide-resistant weeds and effects on non-target organisms. APHIS has evaluated the issues raised by the comments and provided a discussion of appropriate issues in their environmental assessment.
From the notice on
Regulation.gov:
"Based on APHIS' analysis of field and laboratory data submitted by GENECTIVE SA, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, comments provided by the public, and discussion of issues in the EA in response to those public comments, APHIS has determined that maize event VCO-01981-5 is unlikely to pose a plant pest risk. We have therefore reached a preliminary decision to make a determination of nonregulated status of maize event VCO-01981-5, whereby maize event VCO-01981-5 would no longer be subject to our regulations governing the introduction of certain GE organisms."
They then state that they have made available a 30-day review period of APHIS' preliminary regulatory determination of the GE maize, along with their PPRA, EA, and preliminary FONSI for the preliminary determination of nonregulated status. After the 30-day period closes on August 26, 2013, APHIS will review any new information that they have received. If they do not receive substantive new information warranting a change in its decisions, the public will be notified through an announcement on their website. If, however, they do receive substantive new information warranting further review of VCO-01981-5, then they will notify the public and the petitioner and conduct additional analysis.
