Contact Information: EPA Press Office ( press@epa.gov )

WASHINGTON  – Today, May 8, 2024, in response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and the U.S. Department of Agriculture have  developed a plan  to update, streamline and clarify their regulations and oversight mechanisms for products of biotechnology.

The plan helps meet the President’s goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination and efficiency. Through engagement with developers and stakeholders, as well as horizon scanning for novel biotechnology products, the agencies worked collaboratively to develop a cohesive plan. The plan 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. The plan supports a whole-of-government approach to the regulation of biotechnology products.

The agencies have identified five major areas of biotechnology product regulation where these actions will focus:

  1. Modified plants
  2. Modified animals
  3. Modified microorganisms
  4. Human drugs, biologics and medical devices
  5. Cross-cutting issues

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

  • Clarify and streamline regulatory oversight for genetically engineered 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.

The federal government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, the FDA and USDA share responsibility for regulating many of the products of biotechnology in the United States. The Executive Order directs the three agencies to improve how they implement the Coordinated Framework.   

In response to the Executive Order, the three regulatory agencies, in consultation with the Office of Science and Technology Policy, issued a Request for Information to the public to solicit information on regulatory ambiguities, gaps, uncertainties or inefficiencies in the Coordinated Framework. The agencies received 88 distinct public comments, including a sign-on letter from over 6,000 members from biotechnology developers, producers, manufacturers, non-governmental organizations and academia. The agencies will continue to engage with all interested stakeholders as they implement the plan.

Visit the  Unified Website for Biotechnology Regulation  for additional information on modernizing the regulatory system for biotechnology products and Executive Order 14081.

Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

By Sheran Brown • February 21, 2025
Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

By Sheran Brown • February 20, 2025
A renewed push for prescription drug cost reform is gaining momentum in Congress, with the House Energy and Commerce Committee's health subcommittee planning a hearing on pharmacy benefit manager (PBM) reform for late February. The hearing, to be led by Rep. Buddy Carter (R-Ga.), signals a revival of bipartisan efforts to regulate these pharmaceutical intermediaries. PBMs, which negotiate drug prices for insurers and employers, have become a focal point in the broader discussion of healthcare costs. A previous bipartisan agreement to regulate these entities was crafted by Carter and Rep. Diana DeGette (D-Colo.) in the last Congress, though it ultimately stalled when the larger spending bill it was attached to faced opposition. The reform efforts enjoy broad support from both parties and the president, making it one of the few areas with potential for bipartisan cooperation. However, new complications have emerged as Republicans consider using PBM regulations to generate savings for their broader policy agenda, potentially requiring up to $880 billion in cost reductions. The path forward remains uncertain, with ongoing debates about whether such reforms would qualify for budget reconciliation and whether using PBM regulations as a funding mechanism could derail bipartisan cooperation. Meanwhile, stakeholders continue to disagree on the impact of additional PBM regulation, with pharmaceutical companies arguing that PBMs inflate drug costs while PBMs contend that new regulations would increase prices.

Council on State Biotechnology Associations says NIH funds are a critical component of innovation ecosystem

By Sheran Brown • February 20, 2025
The Council of State Biotechnology Associations (CSBA) has issued a strong warning about proposed cuts to National Institutes of Health (NIH) funding, emphasizing the critical role these grants play in America's biotech innovation ecosystem. The statement, below , comes amid concerns over recent guidance that would reduce NIH funding to key research institutions. ----------------------- “Today, the US biotech industry employs nearly 2.3 million people across the US and is making positive contributions to economic impact and national security across all 50 states. In fact, for every dollar the National Institutes of Health (NIH) contributes to a successful drug, the private sector invests over $65, underscoring the agency’s unparalleled return on investment. As the associations representing the bioscience industry across the nation, the Council on State Biotechnology Associations (CSBA) is concerned by recent guidance that would cut funding provided by the NIH to universities, hospitals, and other institutions that perform critical early-stage research. NIH grant funds are a critical component of our innovation ecosystem. Grants for basic research are the spark that leads to university-driven discoveries, with public-private partnerships and tech transfers that bridge early-stage research to industry-sponsored drug development and ultimately to FDA approved medical advances for hundreds of diseases. While the administration looks for greater efficiency in the use of taxpayer dollars, it cannot be overstated - once scientific innovation moves abroad, it may never return. In the race for scientific innovation around the world, as our adversaries continue to increase government investments in research, we encourage President Trump to follow suit and ensure that we maintain our global leadership in an industry that was created and thrives across the US.”
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