The final report from the National Security Commission on Emerging Biotechnology (NSCEB) is now available, and for anyone working in or around biotech regulation, it’s well worth a close read.
The report outlines a national strategy to secure U.S. leadership in biotechnology across a range of domains—research, security, manufacturing, and policy. Most relevant to our work at Hjelle Consulting Group (HCG) is Section 2: “Create a Favorable Regulatory and Legal Environment.”
Section 2 offers a comprehensive set of recommendations to improve the U.S. regulatory environment for biotechnology. These include:
• Enhancing interagency coordination to reduce fragmentation in regulatory oversight.
• Creating clearer and more predictable pathways for emerging product classes like gene-edited crops and engineered microbes.
• Encouraging the use of modern tools and data, such as computational models and real-world evidence, to inform regulatory decisions.
• Improving engagement between regulators and developers, especially early in the product development cycle.
A key theme is the need for greater alignment and coordination—not just between agencies, but also between scientific progress and regulatory practice.
What We’re Seeing in Practice
These are important ideas. At HCG, we work closely with both regulators and innovators, and we’ve seen firsthand how delays and uncertainty in the current system can slow down high-potential technologies.
The Commission’s recommendations largely reflect what many of us in the field have long recognized: there’s room to modernize the regulatory process without compromising safety or oversight.
While some of the broader reforms may take time, the good news is that many of the report’s suggestions can be acted on right away:
• Agencies can build on existing premarket engagement programs.
• Guidance can be clarified to reflect current science and technologies.
• Cross-agency coordination can improve even within existing structures.
These are what I’d call the lower-hanging fruit—steps that don’t require major structural change but can have meaningful impact in the near term.
From a regulatory science perspective, this is a strong work product. The Commission took input from across the field, including the comments provided by both HCG Food Safety Lead Shawna Lemke, PhD on behalf of HCG. Our focus was on gene-edited products and other emerging categories where streamlined, science-based oversight is essential. We were pleased to see that reflected in the final report.
Now the challenge is implementation.
Our recommendation: Let’s start with what we can do now. There’s no need to wait to begin improving clarity, coordination, and communication. These practical steps will benefit both developers and regulators—and help ensure the U.S. remains a global leader in biotechnology.
At HCG, we’re proud to support our clients and agency colleagues alike in building a regulatory system that works smarter—for innovation, for public trust, and for long-term success.
