CBSA and our partners at Biotechnology Innovation Organization (BIO) welcome the joint plan that the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released on May 8 to update, coordinate, and streamline their regulations and oversight for plants, animals, and microorganisms modified through biotechnology. The new Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology is a “whole-of-government approach to the regulation of biotechnology products” that has been anticipated since President Biden’s September 2022 Executive Order 14081 created a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy.  

The Coordinated Framework for the Regulation of Biotechnology 

The Coordinated Framework for the Regulation of Biotechnology was first established by the federal government in 1986 and was most recently updated in 2017. It “describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products,” including how federal agencies share responsibility for regulating biotechnology products in the United States. President Biden’s September 2022 Executive Order 14081 directed the EPA, FDA, and USDA to improve how they implement the Coordinated Framework.  In response, the agencies issued a Request for Information (RFI) to the public to solicit feedback on regulatory ambiguities, gaps, uncertainties, or inefficiencies in the Coordinated Framework and received 88 public comments. 

The new Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology “incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations” to help “meet the President’s goals of ensuring public confidence in the biotechnology regulatory system” and improve “its transparency, predictability, coordination, and efficiency.” 

The EPA, FDA, and USDA have laid out five major areas of biotechnology product regulation where these actions will focus: 

• Modified plants 
• Modified animals 
• Modified microorganisms 
• Human drugs, biologics, and medical devices 
• Cross-cutting issues 

The EPA, FDA, and USDA intend to implement the following joint efforts: 

• clarify and streamline regulatory oversight for genetically engineered (GE) plants, animals, and microorganisms; 
• update and expand their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes; and 
• undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category. 

More information can be found on the Unified Website for Biotechnology Regulation. 

BIO Statement 

BIO released the following statement on May 8 on the EPA/FDA/USDA release of plans for reforming regulation of animal, microbial, and plant biotechnology: 

“BIO is pleased to see today’s report released by EPA, FDA and USDA outlining the joint plan for regulatory reform under the Coordinated Framework for Regulation of Biotechnology to support and sustain biotech innovation and continue growing the U.S. bioeconomy. 

We have been waiting for the Administration to put tangible policy behind the commitments outlined in President Biden’s Executive Order 14081, including reducing regulatory ambiguities, increasing interagency coordination and improving communication to reduce inefficiencies. 

Developers of plant, animal and microbial biotechnology are innovating rapidly to meet the challenges we face, from addressing climate change to ensuring we can feed a growing world. We need a regulatory process that works at the speed of today’s innovation. The agencies lay out in this report a plan to update existing guidance, develop new guidance and streamline processes. 

BIO is also pleased to see the joint news release from the agencies, signaling clear efforts to align and work together. 

We look forward to delving into today’s announcement with BIO members and analyzing its impact on the industry we represent.”