2017 Proposed Biotechnology Regulations

2017 Proposed Biotechnology Regulations

On November 7, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service withdrew the proposed rule to revise the agency’s biotechnology regulations that had been announced in January.

The information and documents below relate to that proposed rule, now withdrawn. We continue to make this information available to all stakeholders for reference purposes.

About the Proposed Rule that was Withdrawn

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.  

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

View the Announcement of the Withdrawal of the Proposed Rule 

View the Federal Register Notice of Withdrawal of the Proposed Rule

Upfront Risk Analysis

In concert with the proposed revised regulations ((now withdrawn), APHIS was  developing a process that includes an evidenced-based, standardized approach to assessing risk prior to making the decision whether to require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  includes either (in most cases):

      OR

  • 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 proposed 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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