APHIS updates biotech regulatory petitions

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The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced the Agency will be sending several biotechnology regulatory actions to the Federal Register for publication in the coming weeks.

First, APHIS posted a notice of preliminary deregulation for Glyphosate Resistant Canola (Pioneer) in the Federal Register on May 29 for a 30-day review and comment period. That notice can be found at www.regulations.gov/#!documentDetail;D=APHIS-2012-0031-0071.   Since the review period ended, APHIS has reviewed the comments the Agency received, finalized the environmental assessment, finding of no significant impact, and determination of nonregulated status.

The next three actions are preliminary deregulations of the following genetically engineered (GE) plants:

  • Glyphosate Resistant Canola (Monsanto)
  • Glyphosate Resistant Corn (Genective)
  • Hybridization System Corn (Monsanto)

“This was the first GE product to complete our improved regulatory review process, and the 3 others are nearing completion” said Mike Firko, APHIS Acting Deputy Administrator for biotechnology regulatory services. “Under the improved process, we met our goal for our review of these petitions after making them available for public comment. We remain focused on providing a more timely and predictable review process while continuing to ensure the safe introduction of genetically engineered crops.”

For the preliminary deregulations, APHIS made the developers’ petitions for deregulation available for public review and comment in July 2012. Since that time, APHIS has evaluated the public comments received and prepared the final environmental assessments and plant pest risk assessments and preliminary findings of no significant impact that support the Agency’s preliminary determinations of nonregulated status.

Under APHIS’ improved regulatory review process for GE plants, because the Agency had previously reviewed these GE traits in other plants, found those plants do not pose a plant pest risk to agricultural crops or other plants, and analyzed their environmental impacts it is issuing its final environmental assessments and plant pest risk assessments and preliminary findings of no significant impact and determination of nonregulated status at the same time. The public has 30 days to review these and provide any relevant information to APHIS; unless APHIS learns of new scientific information during this time, its preliminary determinations will become final and APHIS will no longer regulate the field-testing or movement of these four GE plants.

Notice of publication of these actions in the Federal Register, as well as links to the regulatory documents, will be posted to the APHIS website as they become available.

APHIS will also be publishing draft environmental assessments and draft plant pest risk assessments that the Agency has prepared in response to requests from BASF to deregulate its Imidazolinone resistant soybean, as well as from Monsanto to deregulate its high yield soybean. APHIS previously made BASF’s and Monsanto’s petitions available for public review and comment in July 2012. In response to its evaluation of the petitions, and the public comments it received, APHIS determined that it needed to prepare these draft assessments and make them available for public review and comment. Notification of publication of these actions in the Federal Register, along with links to the draft assessments, will be made available on the APHIS home page. Upon publication in the Federal Register, they will be available for 30 day public review and comment periods.


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