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2015 Stakeholder Engagement on Biotechnology Regulations

On February 27, 2015, APHIS announced the withdrawal of its 2008 proposed rule that would have amended the regulations for certain genetically engineered (GE) organisms. APHIS also published this announcement in Federal Register notice on March 4, 2015.

After withdrawing the proposed rule, APHIS engaged in open and robust policy dialogue to drive the development of a forward-looking rule that will provide a foundation for our future regulatory activities.
This engagement began with an opportunity to provide oral and written comments on the questions listed below. Oral comments were taken in a series of webinars in May 2015. 

APHIS sought input on the following questions:

  1. Should APHIS regulate based on the characteristics of biotechnology products and the potential risks they may pose, or by the process by which they were created?  In either case, what criteria should be used to determine what APHIS regulates? Are there products and processes APHIS should not regulate?  
  2. The Plant Protection Act gives APHIS the authority to protect plant health through regulatory programs. APHIS has implemented the plant pest authority as part of their biotechnology regulations.  Should APHIS add noxious weed provisions to their to biotechnology regulations and if so, how?  What protection goals should APHIS consider?   
  3. Are there legal authorities given to USDA outside the Plant Protection Act that APHIS should examine to regulate or oversee the products of biotechnology? What are they, and how would they be used?  
  4. What non-regulatory solutions or policy alternatives could or should be considered to complement APHIS’s regulatory program?
  5. View Transcripts and Related Materials from the Meetings


View Transcripts and Related Materials from the Meetings

Learn More about the 2008 Proposed Rule




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