2017 Proposed Biotechnology Regulations

2017 Proposed Biotechnology Regulations

About the Proposed Rule

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is proposing to revise our regulations at 7 CFR part 340 regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and our accumulated experience in implementing the current regulations, as well as reduce the burden on regulated entities.  This is the first comprehensive revision of the regulations since they were established in 1987. The proposed rule was open for a 150-day comment period from January 19, 2017 until June 19, 2017 on Regulations.gov, where over 200 submissions were received.  In addition, APHIS held three public meetings during the open comment period.  APHIS is analyzing all comments received before determining next steps.

View the Regulatory Impact Analysis

View Questions and Answers

View Comments on the Proposed Rule

View Federal Register Notice of Comment Period Extension

View the Federal Register Notice and Proposed Rule

View the Announcement of the Proposed Rule

View Information and Transcripts from the Public Meetings

Upfront Risk Analysis

In concert with the proposed revised regulations now being developed, APHIS is developing a process that includes an evidenced-based, standardized approach to assessing risk prior to making the decision whether to require controls (e.g. movement permits).  This upfront risk analysis process will include either (in most cases):


  • A Plant Pest Risk Assessment (PPRA) for invertebrates, microorganisms, and GE plants (where appropriate), to characterize plant pest risk, if any.

Web Based Provisions in the  Proposed Rule

As described in the proposed rule, APHIS is proposing to maintain specific information regarding the regulation on a website. 

About the draft Programmatic Environmental Impact Statement

On January 23, 2017, APHIS published a draft Programmatic Environmental Impact Statement (dPEIS) in compliance with the National Environmental Policy Act, for a 120-day public comment period in the Federal Register.  APHIS prepared the EIS to evaluate the range of alternatives for the proposed revisions to 7 CFR part 340.  

View the dPEIS     

View Comments on the dPEIS

View the Notice of Intent to Prepare an EIS

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