New Stakeholder Engagement on APHIS Biotechnology Regulation

New Stakeholder Engagement on APHIS Biotechnology Regulation

New Stakeholder Engagement on APHIS Biotechnology Regulation

Related Documents, Recordings and Transcripts

In a stakeholder message sent on February 27, 2015, and a Federal Register notice published on March 4, 2015, the Animal and Plant Health Inspection Service (APHIS) announced the withdrawal of its 2008 proposed rule that would have amended the regulations for certain genetically engineered (GE) organisms, and plans for stakeholder engagement regarding biotechnology regulation.

USDA APHIS created a website to serve as a resource on upcoming engagement initiatives. Stakeholders can visit our Engagement on APHIS Biotech Regulations webpage for find background information, associated documents, and details on how to provide input on the future of biotechnology regulation.

This engagement begins with this opportunity to provide written comments on the questions listed below through June 22, 2015.  To submit a written comment on this docket (APHIS-2015-0036) at, click here. (Verbal comments were taken in a series of webinars in May 2015, transcripts of which may be found at the bottom of this page.)

APHIS seeks input on the following questions:

  • 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?
  • 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 biotechnology regulations and if so, how?  What protection goals should APHIS consider?
  • 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?
  • What non-regulatory solutions or policy alternatives could or should be considered to complement APHIS’s regulatory program?

Webinars for verbal comments were held:

Wednesday, May 6, 6-9 pm EDT

Tuesday, May 12, 5-8 pm EDT

Wednesday, May 20, 4-7 pm EDT

May 2015 Public Meeting Documents, Recordings and Transcripts 

You may view all historical documents related to the 2008 Proposed Rule to amend 7 CFR part 340 by clicking here.

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