Biotechnology Innovation & Biosecurity Hearing — September 16, 2026

25:27I recognize myself for five minutes for an opening statement. Today's hearing examines a question that goes to the heart of our national security and economic future. Is American biotechnologically enterprise adequately protected and are your taxpayer dollars that fund it being wisely spent or safely spent?

25:51For decades, the American biotechnology has led the world and become one of our nation's greatest strategic assets. Our researchers, our universities, and our companies have produced vaccines, therapeutics, and innovations that have saved countless lives and driven our economy forward.

26:12But that leadership is no longer guaranteed. The Chinese Communist Party has made biotechnology a national priority, pursuing it with the same coordinated effort and intensity that applied to semiconductors and artificial intelligence. The CCP understands that whoever leads in biotechnology will hold significant advantages in medicine, agriculture, industry, and defense for decades to come.

26:39We cannot afford to be complacent. At the same time, we must ask the question closer to home. our oversight of high-risk biological research kept pace with the risks that we face. In 2014, the federal government paused funding for certain gain-of-function research while it evaluated the risks versus benefits.

26:59In 2017, the Department of Health and Human Services established the P3CO framework, a case-by-case review process. Subsequent experience, particularly with the federally-funded research involving the Wuhan Institute of Virology and EcoHealth Alliance raised serious questions about how effectively that system worked in practice.

27:24I am encouraged that this administration has taken that stretch seriously Executive Order 14292 directs federal agencies to restrict support for dangerous gain and other high-risk biological research where adequate oversight and safeguards are lacking and calls for a stronger screening of synthetic nucleic acids.

27:45These are important and overdue steps but an executive order is only as strong as its implementation and this committee has an obligation to ensure these directives are carried out fully consistently without loopholes for research conducted overseas or outside the scope of federal funding we cannot discuss biosecurity today without also addressing artificial intelligence AI is transforming biotechnology helping accelerate drug recovery discovery and and protein design, and bio-manufacturing in ways that strengthen American competitiveness and saves lives into the future.

28:26That's a progress that I recognize and welcome. But the same tools that accelerate beneficial research can also lower the barriers to biological misuse, making it easier to search, organize, and analyze dangerous biological information which can be weaponized.

28:43We must ensure that the federal support, open datasets, and widely accessible AI services do not become a shortcut for adversaries or bad actors. That is why I introduced the Biotechnology Workforce Alignment Act to close the gap between the federal research dollars we invest in biotechnology and the trained workforce needed to build and scale those innovations here at home, not overseas.

29:11My home state of Georgia is a shining example of this put into action. Without schools like Georgia Tech or the University of Georgia leading the way, we are in big trouble. We need to ensure that American breakthrough translates into real American jobs, manufacturing capacity and economic strength.

29:32I also introduced the Biotechnology Diplomacy Leadership Act to ensure the United States speaks with coordinated voice on biotechnology policy abroad and confronts the risks posed by adversaries seeking access to our data, technology, and capabilities.

29:50I welcome our witnesses today who will help us examine whether federal biosecurity policy and oversight have kept pace with the challenges, how the The divergence of AI and biotechnology is reshaping both opportunities and risks.

30:06And what additional steps Congress must take to keep America's biotechnology enterprise secure, competitive, and worthy of the American people's trust. With that, I yield back the amounts of my time. I now recognize Ranking Member Sykes, the representative from Ohio, for her opening statement.

30:25Ms. Thank you, Mr. Chair, and good morning, everyone. And a special thank you to our witnesses for joining us today. These are very important topics and I look forward to a very robust and nuanced conversation and the respect that this topic deserves.

30:41Biotechnology is an incredibly exciting field of scientific research with immense potential to solve some of our biggest problems. From manufacturing to medical treatments to crop resilience, biotech innovation is racing ahead and generating advances at an astounding rate.

30:54America's leadership in biotechnology has brought enormous benefits to our economy and our society in recent decades. Recent estimates suggest that U.S. biotech sector supports over 600,000 jobs and contributes over 200 billion dollars annually to our national GDP.

31:13Biotech innovation is no less vital for American competitiveness in emerging technologies. The cutting-edge breakthroughs developed in the biotechnology sector position our nation at the forefront of the next generation of scientific discoveries. With the help of the CHIPS and Science Act, the gift that keeps on giving, and my district, Ohio's 13th district, the biotech sector has grown rapidly in recent years.

31:41In 2024, I announced a $51 million investment for the Akron Sustainable Polymer Tech Hub through the the Federal Tech Hubs program. Thank you to this committee. Biotechnology now supports tens of thousands of high paying jobs in Ohio, many of them concentrated in the Akron, Cleveland region and leading at leading institutions such as the University of Akron.

32:04A recent survey found that Ohio's life sciences industry employed nearly 65,000 people earning average annual wages exceeding six figures. Biotechnology is an engine of growth for our local economy and offers tremendous opportunities for working families within our region.

32:20But America's leadership in biotechnology is not a given. There is no question that China has made enormous strides in developing its own biotech in recent decades To compete with China we must and we need to invest in biotechnology with smart policies and a wise approach This is a refrain we hear often in this committee and something that gets rare, bipartisan support.

32:42However, the Trump administration has done the opposite. In May 2025, President Trump issued an executive order that claimed to end federal funding for dangerous gain-of-function research. but the executive order was so broad, so sweeping, so vague, and poorly written, that it had a chilling effect on biotechnology research around the country.

33:03And I want to be clear, biosecurity is a serious issue. And of course we must ensure that biotechnology research is conducted in a way that is safe, secure and responsibly minimizes risk and potential harm to our society.

33:17Nobody disputes that we need a well-crafted safeguards to govern so-called gain a function research when it has a genuine risk of harm. Least of all, the scientific community itself, which truly understands the need for proper safety protocols, clear transparency, and strong ethical guardrails.

33:36But instead of being smart, the administration has embraced a rigid black and white policy that threatens to undermine our innovation economy while impeding our ability to address infectious disease threats and respond to future pandemics and outbreaks.

33:51further challenging this country's public health. Scientists, universities, professional societies, and even federal agencies have struggled to make sense of the ambiguous definition of dangerous gain of function research. As a result, whole fields of science have been gripped with fear that longstanding research might unwittingly run afoul of the new federal restrictions, and their fear is not unfounded.

34:17In the summer of 2025, the administration terminated dozens of research grants, allegedly due to gain of function concerns, including grants in fields such as tuberculosis research that had no plausible connection to any safety risk.

34:33In July 2026, the administration issued a new policy to carry out the executive order, but gain of function remains so ill-defined in the policy that researchers continue to be mystified about whether their own research might be classified as potential or dangerous gain of function.

34:51These definitions are broad, the penalty for violation is high and researchers continue to fear the personal and professional consequences that could result if President Trump decides to target their work The only thing that is clear about the Trump administration approach is that it badly needs guidance from actual scientists, the actual experts and human beings who understand biotechnology and understand how to prudently oversee it.

35:17More than anything, that is what has been missing from this recent debate, the voices of the scientific community who can help guide us to a culture of biosecurity that allows biotech innovation to thrive rather than lockdown mentality than a lockdown mentality that impedes biotech and allows china to get the best of the united states that is one thing that i hope to rectify today and i know dr granville you are a leading scientific expert i hope i pronounce your name correctly and i am grateful for your willingness to testify before the committee so So thank you, look forward to hearing from all of you, and I yield back.

35:51Thank you, Ranking Member Sykes. I now recognize the chairman of the full committee for a statement.

35:58Thank you, Chairman McCormick, for holding this hearing on an issue with significant implications for our entire country. Today we are here to address a field that is increasingly consequential to our national security, to our economic competitiveness, and to our scientific leadership.

36:16Technology is a term that many of us hear frequently, but may not fully grasp just how many industries that it touches. Biotech uses biological systems to develop products, processes, and solutions. As these technologies advance, the field is reaching into an expanding range of industries, including healthcare, agriculture, chemical manufacturing, fuel development, and even artificial intelligence.

36:44in biotechnology can provide tremendous benefits to our communities, our industries, and our economy, but these advances also present significant risks. Laboratory accidents, deliberate misuse, inadequate oversight, or the release of information or biological materials that could be used to harm the public pose serious threats to our national security and to our public health.

37:12Supporting leadership in this field therefore requires not only sustained support for research and development, but also strong and effective safeguards. In May of 2025 President Trump signed Executive Order 14292 Improving the Safety and Security of Biological Research which strengthens federal oversight of high biological research particularly dangerous gain research The order seeks to distinguish legitimate and beneficial biological research from activities that could pose unacceptable risks to public health or to our national security.

37:52Not every country or every company operating within the country shares the same concerns about biosafety and biosecurity. And that is one reason that Congress enacted the Biosecure Act last December. The Act establishes restrictions on federal procurement and contracting involving equipment, services, or other capabilities provided by identified biotechnology companies of concern.

38:20These actions are critical steps, but more work remains to be done. We must continue developing policies, procedures, and oversight mechanisms that balance American leadership in biotechnology with the responsibility to protect our country from serious risks.

38:39China is not standing still. The CCP is rapidly expanding its biotechnology capabilities. Since biomanufacturing capacity, research and development efforts and workforce continue to grow, the United States must strengthen and expand our own capabilities and move faster to stay ahead.

39:01Biotechnology is one of the fastest growing areas of scientific research and manufacturing. The United States must support this growth because it's critical to our economy, national security and to our communities. We will only maintain our leadership in the face of strategic competition if we adopt policies that actually strengthen our domestic capabilities while protecting our research resources and people from bad actors.

39:28I look forward to hearing from our witnesses today about what more we can be doing to advance American biotech research, domestic biomanufacturing, and supply chain security and innovation while while ensuring that the United States remains competitive with China.

39:46I want to thank all of our witnesses that are here today. I'm looking very much forward to hearing your testimony and you sharing your knowledge and your expertise. And I also want to again thank Chairman McCormick for holding this very important hearing, and I yield back the balance of my time.

40:05Thank you, Mr. Chairman. I now recognize the ranking member of the full committee for a statement.

40:10Thank you, Mr. Chairman, McCormick and ranking member Sykes for this hearing, and I want to thank the witnesses for being here and for your testimony. I want to start, Mr. Chairman, by asking unanimous consent to enter into the record a letter from the American Society for Microbiology.

40:28Without objection.

40:28It's one of the country's oldest and most respected scientific societies, and I agree very much with the ranking member that the voices of the scientific community need to be heard in this discussion. ASM has a valuable perspective on these issues, and I'll return to that during our questions.

40:49One of the things that they point out in their letter is that the McKinsey Global Institute has estimated that as much as 60 percent of the physical inputs to the global economy could in principle be produced biologically.

41:00That is a stunning possibility, and I see that one of our witnesses is connected with Dr. Endy. Visiting Dr. Endy's lab at Stanford is mind-blowing to see what the possibilities are. Now this committee has a long and really impressive legacy of bipartisanship and oversight for technology and biosecurity.

41:32The Bipartisan Chips and Science Act had several provisions taking our agencies, tasking our agencies to support research on the safety and security implications of engineering biology And in this Congress, we approved H.R. 3029, a bill to support nucleic acid screening research at NIST.

41:55That bill has since passed the full House, and I wish the Senate would take it up. We're also looking closely at the legislative ideas catalyzed by our colleagues from the National Security Commission on emerging biotechnology, important stuff.

42:11For years, this committee has maintained a deep understanding of and respect for the spirit of openness that animates life science research. Republicans and Democrats have taken biosecurity and safety seriously but also understand that to be world leaders in biotechnology we must be strategic in how we legislate and perform oversight on biosecurity And unfortunately, the term strategic does not really adequately define the actions of the Trump administration in this area and how they've approached the issue.

42:50Ranking Member Sykes has talked length about these concerns, So I'll focus instead on what is at stake for us to lose. One of the things I want to talk about, Mr. Hodges, in your work with Dr. Endy at Hoover, Dr. Endy was part of the research community that contributed to the development of the very first synthetic cells created entirely from scratch, a remarkable achievement for American life science.

43:19And when I texted him, congratulations, he did text back saying that we beat China. So that was a good step forward. But Dr. Andy recognizes that the U.S. can't, he says, ride the brakes on biotechnology innovation and expect to remain a world leader.

43:41I remember touring the lab. a little sign that one of the scientists made that says the Wright brothers didn't need a license. And it's – we have to keep that in mind if we are going to be successful.

43:50And that doesn't mean that we don't take security seriously. We do. But we have to make sure that we also don't stifle innovation in a way that is not strategic. I just want to say a final thing on a concern that I have.

44:07It's not really the purview entirely of this committee, and that's the fact that for years we in the United States have benefited from the fact that 80 percent of foreign-born STEM PhD graduates wanted to stay in the United States and become Americans with us for a variety of reasons.

44:27Hostility towards immigrants, lack of visas availability, hostility. The number of people coming from other countries to get their PhDs in STEM has dropped, and the number who want to stay afterwards has also dropped precipitously.

44:53That is bad news for our country You know a little under 50 percent of the American Nobel Prize winners were Americans who are here by choice Americans born in another country who decided to become one of us.

45:09And losing that will harm us, and it will not only harm the research done here, but also our international partnerships and our dialogue and transparency. So with that, Mr. Chairman, I'll yield back with thanks also for this hearing, which I think is an important one.

45:31Thank you, Ranking Member Loughlin. Now let me introduce our witnesses. Our first witness today is Dr. Anna Mona Frans, a Visiting Research Fellow at the American Enterprise Institute. Thank you for being here. Our other witnesses, Mr. Joshua Hodges, Visiting Fellow at the Hoover Institute.

45:51And our final witness is Dr. Gigi Grombal, professor for Bloomberg School of Public Health at Johns Hopkins. I now recognize Dr. Frans for five minutes to present her testimony.

46:17Babin, Ranking Member Lofgren, Chairman McCormick, Ranking Member Sykes, members of the subcommittee, thank you for the opportunity to testify today. I'm a visiting research fellow at the American Enterprise Institute and a postdoctoral research associate at the University of Notre Dame.

46:36My work focuses on dual-use research, biosecurity, and emerging technology governance. The central point I want to make today is that the U.S. does not have to choose between leading in biotechnology and governing it responsibly.

46:51However, both require active investment in the research that sustains American leadership and in safeguards that keep pace with technological progress. Biotechnology has already transformed sectors ranging from medicine to agriculture, and its impact will grow as the underlying technologies mature.

47:11But the same research and tools that produce those benefits also create risk. this so-called dual-use dilemma makes biotechnology so difficult to safeguard without slowing beneficial research biological threats themselves are not new natural outbreaks laboratory accidents and deliberate misuse are all well documented What has changed is the pace of progress Together with falling costs, the barriers that once made engineering biology difficult are eroding.

47:44AI in particular is changing what is possible and introducing risk with little precedent. Advanced models could reduce the expertise required to manipulate and potentially weaponize biological agents, a concern that has been raised even by the companies building these models.

48:03In a recent paper published in the journal Science, researchers used such models to generate viral genomes from scratch. Sixteen of those designs produce viable infectious viruses. The capability to design novel pathogens creates new risks for two reasons.

48:22These pathogens may not resemble anything found in nature, so existing safeguards may not recognize them. And a pathogen that is optimized for the sole purpose of causing harm could be more dangerous than anything natural selection has produced.

48:39These risks are substantial, but tractable safeguards have been identified. Here, I want to focus on three. First, Congress should require screening of synthetic DNA and RNA orders. DNA and RNA are key ingredients for life sciences research.

48:57Researchers order custom sequences from commercial providers. To date, no binding federal requirement obliges those providers to screen synthesis orders or to verify their customers. rest on voluntary industry screening. But an actor turned away by one provider can simply order from another that does not screen.

49:15Congress should establish the requirement for every provider to screen orders and verify customers. The bipartisan biosecurity modernization and innovation act introduced in the Senate earlier this year would be a major step towards that goal.

49:29Second, Congress should fund pathogen agnostic bias surveillance. Most surveillance today targets specific known diseases and would likely miss a novel threat. And funding has followed a pattern. It surges during each crisis in contracts afterwards, letting capacity erode before the next crisis arrives.

49:54Congress should provide stable, multi-year funding for pathogen-agnostic detection systems. The capacity has to be in place before a crisis and cannot be assembled during one. Third, Congress should close two gaps in federal research oversight.

50:11Recent federal dual-use research governance policies, such as the July 2026 U.S. government policy for stopping high-risk life sciences research, could significantly strengthen oversight. Realizing that potential will depend on implementation and on clear guidance for the scientists and biosafety officers who apply these policies in practice.

50:34Two remaining gaps require legislation. The policy does not reach purely computational design of biological agents and it binds only institutions that receive federal funding. Together these three measures would address serious risks without impeding progress.

50:52I appreciate the subcommittee's sustained attention to these important issues and I look forward to your questions.

51:06Thank you Dr. Franz. Now I recognize Mr. Hodges for five minutes to present his

51:11testimony. Thank you Chairman McCormick, Ranking Member Sykes, members of the subcommittee. I also want to thank the chair and ranking member of the full committee for being here today. This is a topic that could not be more timely.

51:18In addition to serving as a visiting fellow to Hoover's biostrategies and leadership initiative, I also serve as commissioner to the US-China Commission. That Commission has taken ample time to look at this issue as well, but I do want my views today are my own and not necessarily reflective of the entire Commission's, but we have taken several recommendations in the past on this issue.

51:40Biotechnology is currently squarely inside the Chinese Communist Party's active campaign to destabilize the United States and overtake us when it comes to strategic priorities that we need in order to maintain our leadership role in the United States and internationally.

51:56And their campaign stems from research to data to manufacturing to talent and finance. And they're working to dominate a field with enormous potential for America and to make us reliant on their companies for the future.

52:06As I was listening to the opening testimony I couldn't help but notice that there's a there's a quote on the wall by Tennyson, for I dipped into the future as far as human eyes could see, saw the vision of the world and all the wonder that would be And it struck me that this is an incredibly apt quote to be on the wall for this hearing today As several of you have alluded to this field is very exciting It got enormous potential and it mind I have been absolutely amazed over the past year through my work with Dr Indy and at Hoover as we traveled internationally and looking at the capabilities and some of the things that American high school students and international students are working on.

52:41So again, the potential here is enormous from an economic opportunity, but the Chinese are actively working to make sure that they control it instead of the United States. This is an uncomfortable topic, but one we cannot ignore.

52:58The threats are real and the clock is real. In the last eight months, there have been over a half a dozen Department of Justice and federal actions working to prevent incidents inside the United States where they've uncovered up to labs buried under houses and other types of efforts here in the United States.

53:15Again, most of these were not uncovered because we have a really robust intelligence system. One of them was uncovered by a maid who got sick. That should be a massive warning sign to every member of Congress that we clearly don't have the tools in place to detect these types of pathogens that are dangerous for Americans and have a clear, direct line to threats.

53:34Multiple commissions, academia and the private sector have independently landed on the same deadline. The next 19 months is vital. China is building to that time frame. Its 15th five-year plan makes biomanufacturing and advanced materials a national priority with explicit goal to lead the world in biotechnology by 2035.

53:52And this is the honest picture. They're running an all-of-society effort on biotechnology. They're pulling ahead on clinical trials, manufacturing, supply chains. The United States is still leading on talent, finance, and innovation. So the question that we need to answer today is simple.

54:07How do we use our strengths to our advantage? Our lead in the United States is our laboratory and our innovation. We fall short where it matters most, on the factory floor, because that's what's driving future business.

54:17China has surpassed us in clinical trials in 2020 and medicines in 2023. Again, these should all be wake-up calls for this committee. And again, I applaud you for the letter that you sent earlier this month to several departments and agencies urging them for leadership.

54:33And frankly, that is what we need most. And as it was previously alluded to, I'm just going to kind of brush over this part by Dr. Franz. Since the advent of AI is increasing and raising the stakes on this beyond state actors and lowering the threshold for some of those dangerous pathogens, it's expanding that.

54:54So this is absolutely an area where safeguards should be considered again not to stop the technology from advancing but to work alongside of it Biotechnology can be dangerous It yielded but it has also yielded modern innovations and countless medicines and tech advancements.

55:08We're seeing it cut lead times and actually provide benefits to Americans on a daily basis. The natural instinct within technology is emerging is to wall it off. As we all know, history is not kind to that instinct.

55:20There's countless examples in my written testimony, which I submitted, that demonstrate us. The stakes cut both ways. And so what can Congress do? In my written testimony I have provided a number of recommendations, but just to give you sort of the top line ones that we absolutely must advance that the Committee is actively working on is biological intelligence and measurements.

55:37We cannot secure what we cannot see and we cannot win what we cannot measure. On biological intelligence, the United States still lacks a coordinated real-time capability to see biological threats, whether naturally occurring, accidental or deliberate, as they emerge.

55:54This is something that Congress should absolutely take. I appreciate the chairman raising the BioSecure Act. In addition to that, last year Congress passed the outbound legislation. I would urge you to take a look at expanding that to include biotechnology into that as well.

56:10Thank you, Mr. Hodges. I now recognize Dr. Gromval for five minutes to present her testimony.

56:19I'm Carmen McCormick, Ranking Member Sykes, and members of the subcommittee, thank you for inviting me. I am Gigi Granval, a professor at the Johns Hopkins Bloomberg School of Public Health. The views I express today are my own and do not necessarily represent those of Johns Hopkins University or the Johns Hopkins Health System.

56:35The National Security Commission on Emerging Biotechnology warned in April 2025 that the U.S. risks falling behind its global competitors, especially China. China has produced world-class scientists and breathtaking innovation, but as the Commission's report makes clear, not all its successes have come from fair competition.

56:55Much of the U.S. policy response is therefore focused on protecting American research from theft, exploitation, and misuse. That is important. But U.S. science must also continue producing something worth protecting. Since the Commission released its report, U.S. policy decisions have significantly weakened to our biotechnology research enterprise.

57:16Research grants have been terminated or delayed, clinical trials have been disrupted, job offers have been rescinded, American scientists have been recruited by other countries students and early career researchers increasingly question whether the biological sciences can offer a stable career Talented researchers from abroad are choosing to train and work elsewhere instead of contributing to American science.

57:40This is a national security crisis. The U.S. also confronted a conflict between competitiveness and security during the Cold War. The Korson Committee concluded that despite the risks of openness, the United States would be more secure if it preserved its capacity for scientific innovation, an approach known as security by accomplishment.

57:57That principle became the basis for NSDD 189 signed by President Reagan in 1985 and reaffirmed several times since. Openness and achievement are especially important in the biological sciences. Biology is studied everywhere. Infectious diseases cross borders and countries other than China are also moving forward rapidly.

58:17If the US does not pursue security by accomplishment, other countries will make discoveries and establish scientific norms without us. That will leave the United States more vulnerable, not more secure. The new federal policy for stopping high-risk life sciences research is another symptom of this problem.

58:40Its broad definitions prohibit or create disabling uncertainty around public health surveillance, animal model development, and medical countermeasure research. The policy acknowledges that vaccine development could overlap with prohibited activities, but it provides no exception process.

58:58Even before this policy, scientists and universities avoided work that could conceivably be labeled gain of function. That chilling effect has already prevented important research. I witnessed this myself at a vaccine conference in Kyoto in 2025.

59:14Chinese researchers presented work that helped explain how H5N1 influenza was spreading among American dairy cattle. Qualified American researchers should have been able to investigate promptly how the virus was spreading through American herds and how to stop it.

59:30Yet at that same conference, one American scientist after another described important H5N1 experiments that could not proceed in the existing regulatory and funding environment. I respectfully urge Congress to take three actions. First, require agencies to account for congressionally appropriated research funds and the and the reasons those funds have not reached researchers.

59:53Second, call for suspension of the new high-risk research policy and use the more workable 2024 framework while a clearer and more effective policy is developed through a transparent process involving practicing scientists, biosafety officials, and independent biosecurity experts.

60:10Third, implement the Commission's recommendations to sustain biotechnology research, expand domestic biomanufacturing and workforce development, strengthen biological data resources, and improve regulatory coordination. We need effective biosecurity protections against theft and misuse like gene synthesis screening and AI biosecurity safeguards.

60:29But as we cannot rely entirely on preventing all threats, we need to make sure that we also have the facilities, manufacturing capacity, international relationships, and most importantly, the scientific talent, the people who allow us to recognize biological threats and defeat them.

60:45Thank you, and I look forward to your questions.

60:51Thank you. To all our witnesses for their opening statements, I now recognize Thank you, Member Sykes, for five minutes of questions.

61:00Thank you all. Quite fascinating testimonies. I'm sure we'll have a great discussion here. Dr. Granville, you testified that President Trump's gain of function, EO, and the administration's policies would, quote, prohibit or create disabling legal uncertainty around activities that are required for medical countermeasure development, public health surveillance, animal model development, and ordinary research posing minimal biosafety risk, unquote.

61:25You testified that the administration's actions had created a chilling impact on biotechnology research. And this is precisely what the scientific community has been warning about for over a year. So 40 universities, research societies, and biosecurity stakeholders warned in a joint letter to NIH all the way back in July 2025 that the administration policies risk paralyzing critical areas of biomedical research.

61:50So, Mr. Chairman, I request you may have consent to enter this letter into the record.

61:54Without objection?

61:55Absolutely. And I want to take this opportunity to better understand the real-world impacts that have already happened. Dr. Granville, the example that you gave about the H5N1 was quite incredible, especially considering the challenges that we have had with dairy cows and beef here in the United States and wanting to protect what we have here rather than outsource it.

62:16And it often seems like there's a Trump policy attempting to do something while also undermining our economy at the same time and that is a perfect example of it But what the current definition of gain of function was developed as you say or many have said developed without meaningful input from a community expected to comply with it.

62:39And that doesn't sound like evidence-based policymaking and ignores your expertise. If the Trump administration were to actually engage, what would you tell them and how to best oversee and regulate this area?

62:56Thank you very much for the question, Congresswoman. I think the most important thing is to make sure everybody wants to have important work get done, and they want it done safely. And so that is the priority.

63:10And what you call it, what kind of category you put that in, that's the most important thing. And so how you do that is you make sure that you talk to the people who are part of the regulated community because you want to make sure that the important work that has clinical implications with regard to H5 and influenza or whatever you might might be worried about you want to make sure that that work can go forward the problem with the policy is is is that some very important public health stuff is already prohibited it's there and it doesn't seem like there's an exception process so there just seems to be like no duty of care to make sure that we can do this work that will have clear benefits for the clinic or for public health.

63:58Thank you for sharing that. And it seems to, I'm thinking of the parallel of the conversations we're having right now with AI regulation and the administration says let the industry figure it out, but when it comes to biomedical and biotech research it is through executive order.

64:13It doesn't quite make a lot of sense, but we hear that quite often. So you discussed the workforce in ensuring that people are confident and capable of doing the work without fear of retribution or punishment.

64:27Can you talk a little bit more about the chilling effect of the workforce and also of the scientific gains of these EOs and strange conversations from the administration?

64:38Thank you for that question. I think that when it comes to gain of function, potential gain of function research, I think people are very concerned about the potential optics and it's just another layer of there should be an ongoing conversation of what work needs to get done what questions we need to answer how can we do it the most safe and the most safe manner And that is a conversation that should be with the scientific community biosafety experts biosecurity experts, but instead it has been this overlay of how much trouble could I potentially get in, how much harassment might I be bringing onto myself or my institution.

65:12And institutions can be quite wary of that attention as well. So I think there is a lot of self-censorship in what projects are proposed, and I think that is perceived in the international community as well.

65:30And I think if you talk to the scientists in your districts, you'll see that that's the case. When it comes to workforce generally, I think there are bigger problems because we don't have the workforce that we want to have.

65:43We at Hopkins, just speaking from my personal observations, we have been able to only accept a few graduate students where we normally accept several dozen, and that's the case in universities across the country, and so it's a problem.

66:01Thank you so much. I yield back.

66:08Thank you, Ranking Member Sykes. I now recognize full committee, Ranking Member

66:13Lofgren for five minutes of questions. Well, thank you, Mr. Chairman, and thanks again for this hearing. Dr. Granville, you made a point in your testimony that I think is correct. Protection alone can't preserve American scientific leadership because we have to produce something worth protecting.

66:32And our scientific accomplishments are vital to our national security. And if we erode that capacity, it's going to open the door for other nations to achieve what we can't. So let me just return to the ASM letter which I entered into the record during my opening statement.

66:53They informed us that, and this is a quote, a competitive shift has already occurred between the United States and China in the biotechnology area. Biotechnology is a broad term. many sub fields with many different applications but the overall evidence seems that the relative R&D spending the number of clinical drug trials the flow of licensing technology from China to the US instead of the other way around is something noteworthy something is happening it maybe it already has how would you assess the near consequences of this competitive shift in biotechnology

67:37innovation thank you for the opportunity to reflect on that I think that the issues involved here are very complex and certainly the US has not been able US researchers have not been able to collaborate in the way that we used to with our international counterparts.

67:57And I think that there once was a time when the US was the only game in town. The US biotechnology was born in the US, but now it's not just US and China. There are many countries that have fantastic scientific collaborators that we would like to work with.

68:16And so when we're not part of that biotech ecosystem, when we pull back, that area gets filled with others, and mostly China. And so I think that that is what you're seeing now, is that we're not being able to be fully present in the scientific community.

68:41Let me just mention, I mentioned earlier visiting a couple of times the bioengineering lab at Stanford and I came away with their report, the Hoover Institute report, biosecurity really, a strategy for victory, which you mentioned Mr. Hodges in your testimony.

68:59Matter of fact I was so impressed with it I shared it with the chairman of the full committee and I'm mindful and if you have a comment on this, it doesn't look to me that what the administration has done in biosecurity really matches the recommendations in the Hoover report.

69:12Do Do you think that's unfair? MR.

69:20The way I would respond to this, ma'am, is the system, I think we can all agree, again, China has been rapidly catching up to us. MS. Right. As I said in my opening testimony, as others have alluded to, there have been a number of commissions that have said that China is rapidly catching up to us.

69:36In response to the last question, it was just asserted that, you know, the United States is having a hard time engaging with some of our allies and partners. Again, that's not a new phenomenon.

69:44This has been a problem in the works for decades. So I don't think we can put the problem squarely on the administration's shoulders with their recent sort of funding decisions and sort of memos that have come out.

69:56I think they've prioritized biosecurity and biotechnology generally. they are still looking at this problem and I think there's still ample room for engagement to make sure they get it right. Again, if we look in the rearview mirror, then I think we're going to have a really hard time.

70:09I think what we need to do is prior to, and again, the big part here is money alone isn't

70:14going to solve this problem. No, I understand that. One of the things that I'm interested in, and this committee doesn't have jurisdiction over FDA, but we've had clinical trials move away from the United States, and that's not just a funding issue, that's a bureaucracy issue at the FDA.

70:32I don't know, Dr. Granville, over from your perch, whether we could do something in terms of the structure of the clinical trials so that we don't send everything to China as we used to.

70:46I mean, you've, at John Hopkins, I'm sure you've seen this.

70:49This is a big priority for patients. We want patients to have the latest cancer advances, et cetera, in the U.S., and it's really a burden to travel to other countries to get that. And of course, it's only for people who couldn't do that.

71:04Correct. Yeah. Let me just… May ma'am, there's one piece on this I also want to just add on. The other part of this is something I alluded to in my opening testimony, which is, again, I recognize it's outside of the community's jurisdiction, but from an oversight perspective, it's something you absolutely should be aware of.

71:19Another reason a lot of that licensing is happening is because American firms are investing in Chinese corporations that are doing this work. And so again, the United States is funding the rise of the Chinese.

71:30And so that's something that Congress could definitely take an action on right now and work with the administration.

71:34The final comment I wanted, I know my time has expired, but I can't tell you the number of university presidents who have come to me to say that the kind of mindless grant cut-offs in biotech and health have caused them not to admit otherwise admissible doctoral students and postdocs because they don't know how they're going to pay for the research and so we've had a dramatic reduction that's kind of hidden from view of the scientists who we've lost them they're either going to go to another country or they're going to go to biz school they're not going to be scientists here and that's something that we could it's really a self inflicted wound and we need to stop it if we can mr chairman I know I used more than my time so I will yield back Thank you Ranking Member Lofgren I now recognize Member Bonamichi from Oregon

72:39I should know that since I'm from Oregon too.

72:42Yes, I know. Thank you, Mr. Chairman, and thank you, Ranking Member Sykes, and thank you to the witnesses for this really important conversation. Yes, I represent a district in Northwest Oregon, and certainly innovation in the biotech sectors, generating life-saving medical discoveries, safer and more sustainable food products and cleaner energy solutions.

73:03It's also an economic driver. There's close to 2,000 different firms of all sizes in Oregon, bioscience firms of all sizes in Oregon, about 21 billion annually, supporting a lot of family wage jobs across the state.

73:16In fact, in the district I am honored to represent, and NTTAC just announced a $750 million investment that's gonna double their size there. Oregon Health Sciences University and Oregon State University are investing in the workforce and the research.

73:30But we can only maintain our lead and do it safely if our biosecurity oversight systems keep pace with the development and the executive order we're talking about today is not the answer. I wanna thank you, Dr. Granval, for also highlighting all of the issues affecting science and the concerns about us falling behind.

73:49I share those concerns as a long-time senior member of this committee, also the Committee on Education and Workforce. Research funding cuts, we've heard many times that it's difficult, if not impossible, for international students to come here to study, but also even to attend conferences with these draconian, inhumane immigration policies.

74:08All of these things are affecting the growth and potential in biosciences and sciences in general. So Dr. Granville, you described in your testimony, you gave an example of how prohibitive restrictions on dangerous gain of function research and international coordination.

74:26Your example was a chilling effect on research to combat avian flu transmission. We were all of course concerned about safety, but this administration's recent executive order, it's seeking global leadership in biotechnology, but it looks like it's doing this by tying scientists' hands behind their backs.

74:44then I just wanted to get a sense from you, what are some of the specific examples of discoveries that US researchers might likely seed because of this vague and somewhat myopic policy and how does research isolationism undermine the economic growth and as you mentioned the U leadership and as Ranking Member Lofgren mentioned we have to have something where we're leading.

75:05So could you answer those questions, like what are some examples and then how does this research isolationism undermine the growth in the industry?

75:17Thank you for the opportunity to talk about that, Congresswoman. So I think that there's There's a couple things. There's some specific areas of research of public health importance that I think would be either prohibited or would be cloudy and people would be hesitant about, and that involves outbreak response, getting samples from potential outbreaks, creating animal models so you could study different viruses more safely and more expeditiously in the laboratory.

75:48And so those things, either they are prohibited, they appear prohibited, but even if they're not, the fact that we have this question raises, will make people pause. There's also the institutional burden of trying to figure out what goes in scope and out scope of this, you know, all of, so I appreciate that we didn't want to have a list of things to be concerned about, but when you don't have a list, sometimes that just means that everything is on the list.

76:17And I'll note that it's already challenging circumstances and then to add this vagueness and uncertainty there. I just have a question that the EU's poised to pass the Biotech Act. I don't know if you're familiar with it, but it's gonna create a mandatory screening mechanism to stop risky fragments of DNA, for example, falling into the wrong hands and potentially triggering a man-made pandemic.

76:36Do you think that's a good idea? Is that something you should consider?

76:39I think screening of gene synthesis products is important. I was involved in the passing of AB 1963 in California for gene synthesis screening, but I just want to caution that that cannot be the only thing that is done because you don't need to have gene synthesis screening to be able to get your hands on dangerous pathogens, and if you have nefarious intentions in mind, there are other paths to do that.

77:11And I don't think that just putting all the eggs in the prevention basket is going to work here. So you really need to be prepared to respond to public health threats whether they are from deliberate or not.

77:23I want to get one more quick question And last week Google DeepMind released an alpha genome atlas that can map 9 billion genetic variants pinpoint disease mutations will be searchable by any researcher in the world.

77:38And I just want to ask you, do tools like this sort of compressing years of genomic analysis into a single search, do they create safety concerns? And should Congress consider policies to update screening in light of this type of development?

77:50So thank you for the, I think that these, there are dual use risks when it comes to all kinds of advances in biological sciences, which is why we need to keep an eye on security while also promoting its positive use.

78:05But just like you can't totally rely on prevention, there are also, it's very exciting to see what is coming about. And we wanna make sure that we maximize the benefits for biotechnology for health and security.

78:20I now recognize Mr. Foster from Illinois for five minutes of questions.

78:29Thank you to our chair and to our witnesses. I guess I'd like to start with some more workforce issues on this. Basically international STEM scientists in biotechnology. The recent data from the NSF, the Center for Science and Engineering Statistics in 2024, reported that 24 percent of the U.S. doctoral recipients in biological and biomedical sciences were temporary visa holders.

78:58This Congress, together with my colleague Mike Lawler, we introduced the bipartisan Keep STEM Talent Act to allow international STEM graduate students who are studying in the U.S. to stay here after graduation and contribute their skills to our economy.

79:12I guess it's a sign of our global scientific leadership that we are, or at least we were, able to attract and retain top talent from all around the world and helping maintain our country's lead at the cutting edge of scientific research and technological development.

79:26But right now, many of these students are being targeted with visa revocations and deportations, which is causing considerable damage to our research enterprise by preventing international students from contributing to our national biotechnology success, as well as discouraging inspiring students from coming here to study.

79:43So I guess Dr. Grunwald or anyone else who wants to, well, Dr. Grunwald, in your testimony, you spoke about the importance of maintaining our leadership as a place that scientists want to do research.

79:56I know in physics there's a lot of unhappiness about a lot of what's being done done by this administration. A lot of physicists who would have loved to come to the U.S. are not interested anymore.

80:03Could you speak on how international students and visa holders have contributed to U.S. leadership in biotech and biotech research and development?

80:15Thank you for the question, Congressman. I personally had a student, a potential student, decline to start a Ph.D. program because he was concerned about the actions, immigration actions here. And so it's a very serious thing.

80:27We have not been able to accept as many students as we would like to. We normally have. And this has really big consequences for early career research overall. They're the ones that are being hit most by this.

80:39But as far as the contribution of international students, I mean, you know, biological science has been international for quite a long time. The recent Nobel laureates, English is not their first language and and and so be having being building a biotech ecosystem here is what gave us quite a few great nobel prizes including crispr cas9 and mrna vaccines yeah i want to say kid i grew up with

81:11emily karana the daughter of a name that you probably recognize from biotech um it is a it is It's just a, it's an incredible situation. There's a related thing having to do with the clinical trials going offshore into China for largely economic reasons, and the danger that I see there is that could actually pull a lot of fundamental research over time.

81:38Any comments on that? It's a real concern.

81:42It's a real concern. I think it's a little bit it's been something that the industry has been warning about for some time and there's other models that people have been.

81:50They're warning about but profiting greatly over doing cheap, you know, sort of one phase of the research and then they say, well, as long as we're doing that phase of the drug development, let's do all the phases and then pretty soon everything's gone.

82:03Yeah.

82:04Mr. Hodges? Yes, sir. Just to jump in here. And so this was one of the issues I raised in my opening testimony is in addition to just doing it because it's cheaper, we also have the experience of U.S. firms funding it.

82:15And so essentially we're funding Chinese companies to compete against American technologies, which is exactly what China wants. I just returned from China about two months ago, and one of the key things I took away from that trip in addition to some discussions I had with some CEOs is China thinks it winning And they know if the current path continues they going to own the market And that's what they're hoping for, and that's what they want.

82:37So you're absolutely right to raise this issue. And there are steps that Congress can take right now, working with the administration in a bipartisan manner, to address this and stop this. Part of that is regulatory change.

82:47So it's not just cost-effective to do business here, but it's also timely. And that's one of the big things is it takes a month and a half to do something in China. It takes eight months, nine months, maybe two years to do it here in the United States.

82:59So addressing both of those together would be one way to address your problem, sir.

83:03Yeah. And frankly, the safety standards in China are different, and that is a tougher discussion. Absolutely. Now, one thing that has creeped me out for a while is the desktop gene synthesizers. What's the status of getting those under control internationally?

83:19You know, there are more than a dozen startups that say, oh, it's a wonderful RNA synthesizer that's on your desk. And so, you know, you need one depressed graduate student to do real damage with customizing a lethal virus.

83:33What – how's that going? Is there – is there real international progress on getting those under control?

83:38Well, I've heard discussions of trying to make it so it's difficult to actually use the machines for – for harm. But I totally agree. There's a limit.

83:48At least they're not even logging what's been done on them, which is insane. I mean, it seems like you'd have to first off show up with a secure digital ID and prove you are a legally traceable human from a country that we have extradition treaties from to even operate these machines.

84:04And then once you've done that, you should log exactly what you've done in some privacy preserving way if you're in a drug company with IP. But you just shouldn't let these things go free.

84:15a predictable disaster and especially with AI tools. Anyway, longer discussion. I thank the chair for his forbearance in letting me go a little long on this.

84:25Thank you, Mr. Foster. I now recognize ranking member Babin from Texas. Ranking member?

84:30Not yet.

84:31I'm sorry, sorry. Oh my gosh. Wow. You know, I just want to point out that this has been a long day because we basically had five against one until you showed up. I'm used to that.

84:44I feel like you're the ranking member right now. Chairman of the full committee, Dr. Babin from Texas.

84:54Thank you Mr Chairman I have a general question that I like to ask Not all gain research presents the same risk yet certain experiments can increase transmissibility harmfulness or host range After the failures associated with the federally supported work involving the Wuhan Institute of Virology and Equal Health Alliance, do you believe existing agency review processes still reliably identify covered experiments?

85:20And should equivalent standards apply to foreign sub-recipients of U.S. awards, and how would you enforce that requirement? Those questions. I'd like to start with you, Dr. Franz.

85:37Thank you for the question. So the first thing to say is that our dual-use research governance policies have been updated considerably since the research at the Wuhan Institute was funded, And some of those gaps have been closed.

85:50First of all, certain categories of research, dual-use research of concern, have been completely suspended. And also research that includes countries of concern has been suspended as well. There's a separate category of research that does not clearly fall into one of those two categories.

86:06And for those, there is an additional review process and including an independent third party review. Another thing that has been updated is going from a list-based approach, so covering a list of pathogens of concern, to an approach that focuses on the risk that stems from this research.

86:30And a final thing I want to say, an additional update has been made to starting from assessing the risk at the point of funding the research. and oversight has been extended to the entire research lifecycle.

86:46And all of these have the potential to significantly improve oversight. We are still waiting on the implementation guidance, and a lot of this will depend on how well the implementation guidance is crafted.

86:59Okay. Mr. Hodges, as quickly as possible, if you don't mind.

87:03Yes, sir. I would agree things are improving. There's still limited control of some of these types of pathogens, and that's part of the reason we need to increase the bio intelligence and bio-int as we refer to it at Hoover.

87:16I agree things are improving, but there's a lot of work to be done.

87:19I'm sorry, Dr. Gronval. I'm going to have to go on my next question. I running out of time We don have five minutes And Dr Franz how should Congress distinguish legitimate beneficial biological research that must proceed from the narrow class of experiments that should not be supported by U.S. taxpayers, especially experiments that could create a pandemic-capable agent?

87:43Yes, thank you for this question. Yes, this is a very important issue and the distinction to make because we do not want to impede beneficial research. And even within pathogen research, we only want to focus on a small subset of research.

87:58And guidance for this has been outlined in the new 2026 policy, focusing on research that has the potential to cause outside harm for societies. I think this is a good approach focusing on, and in addition also focusing on risk-benefit analysis.

88:14How much benefit are we expecting from this research, and is it worth a certain level of risk?

88:19Gotcha, thank you. Mr. Hodges, Executive Order 14292 restricts federal support for dangerous biological research conducted by foreign entities, quote, where adequate oversight and biosafety enforcement are unavailable, unquote. Who determines what counts as adequate and what objective standard is being applied so that the determination does not simply default to whatever a foreign institution claims about itself?

88:47Yes, sir, thank you for the question. This is one of the main issues we're seeking to address from Hoover in our report that we raised is that currently it's spread out across 15 agencies.

88:58And as I'm sure you would agree, that's not an adequate approach for something of this magnitude and this degree of threat. It's why we appreciate your attention to the issue today. I do just want to also raise sort of the point that the United States has never made sort of a transformative safe technology safe by refusing to build it.

89:14We've always found ways, for example, when we were establishing sort of the gas pipes throughout the United States, we found ways to do that in a safe way. Otorization was the technique that we developed.

89:26I believe we can find the same way to do that with some of these things that have potential to be dangerous but also have positive outcomes as well.

89:33And that otorization happened because of a catastrophe in the state of Texas, north of my district, as a matter of fact. Real quick, Dr. Franz, you've argued that biosafety and biosecurity should be treated as conditions of responsible research, not as afterthoughts.

89:50Absolutely. What minimum biosafety, biosecurity, and personnel control should be required before any federal award involving high consequence power?

90:00Yeah, very briefly, we are concerned about two different risks. One is the biosafety side of things, so the laboratory security that research with high consequence pathogen is conducted under the appropriate safety levels, that personnel has adequate training.

90:14But the other concern is that the results from research and data provide a risk as well and could be misused in the wrong hands, and so we have to safeguard this side of the risk as well.

90:25Yes, ma'am. Thank you, and I'm out of time, so I'll yield back, Mr. Chairman.

90:29Thank you, Mr. Chair of the full committee, Dr. Babin from Texas. I recognize Ms. McLean Delaney from Maryland.

90:39Thank you to Dr. Babin, our chair, and the ranking member for hosting this incredibly important hearing and one I really care about, about biotechnology, innovation, and biosecurity. So I represent Maryland's 6th congressional district, and we're home to some of the top research institutions in the country including NIST and parts of NIH and two BSL-4 labs at Fort Dietrich which are really incredible including the National Biodefense Analysis and Countermeasures Center where some of our best and brightest conduct research on the most dangerous pathogens in the world to keep us safe.

91:12I do have to echo Congressman Foster's sentiments which I just wrote in the in the margins of the importance of international collaboration and ensuring our international students and scientists continue to be able to be in the U.S. and ensure that there's adequate workforce and international collaboration.

91:27So now biotech isn't just the future, it is here now, and we need to make sure we're driving cost-effective and timely. I heard that, and it's really important. Biotech innovation for these therapies, fuel, and to bolster supply chains, and to do it responsibly.

91:46I believe it drives our U.S. competitiveness and national security, and it underpins so many important entrepreneurial companies along the 270 corridor in Maryland but across the country. Now part of this balance is our ability to develop standards and metrics for consistency of past the bioeconomy and I introduced this year the scale biology act.

92:01I co-sponsored it with Representative Obernolte and and many on and Zoloffrin which would establish a biometrology I WANTED TO BE ABLE TO BE ABLE TO THEM TO THE COMMITTEE AND I'M HOPEFUL IT HAS PASSED THIS YEAR IN THE HOUSE BUT MARYLAND AND THE NATIONAL CAPITOL REGION CONSISTENTLY RANK AMONG THIS BIOTECH RESEARCH AND I HOPING IT TO BE ABLE TO It has passage this year in the House But Maryland and the National Capital Region consistently rank among this biotech research And the National Security Commission on Emerging Biotech held a roadshow in Rockville this past week And they laid out a strategy vis-a-vis China.

92:44They found that we were at risk of losing our global edge, as we've been talking about. and part of it, they also noted the slashing of research funding and some poorly written policies that have kind of hindered biotech.

92:58That report highlighted that while many different departments and agencies within the U.S. government have biotechnology programs, there's minimal interagency coordination and no comprehensive whole-of-government approach as opposed to China. So my first question for all of you would be, given that China has leveraged a whole-of-nation approach, would a routinely updated national biotech strategy improve how federal agencies coordinate and collaborate with academia and industry?

93:29And also, do you all see value in my scale biology act? First question.

93:36Yes, ma'am. I'll just go first. I absolutely agree. It's vitally important. and we thank you for your leadership on this issue, both from the Hoover perspective, as well as the US-China Security Review Commission.

93:49Our number four recommendation last year was exactly that. And so we thank you for your leadership on it. Great bill. Thank you to the committee for passing it through and look forward to that progressing further.

94:00And anything about how federal agencies coordinate and collaborate with academia and industry from any of the others?

94:07There's a lot of work to do. We could be updating the coordinated framework. We need to have a very predictable pathway for biotech products to go to market and to still be reviewed for safety and efficacy.

94:23I mean, we just need to, we could do better than we do. We could use the staff at the agencies that are expert in this, however, and that is another reason why there's slowdowns because we don't have thousands of PhDs that used to be there.

94:39And I note, I found very important coming from a tech and telecom background about the security of the data, that you also are able to accrue in some of these labs and we make sure it doesn't get into the wrong hands but is shared in a collaborative and safe way.

94:53Dr Franz anything Yeah no thank you for your leadership on this issue I agree that all of this needs better coordination and a concerted effort so that we can compete with the effort that has been done in China.

95:09MS. And last quick question for any of you. What would happen if China took the lead in this biotech innovation? What might happen to some of the medicines in our cabinet or the food in our pantries?

95:22MR.

95:23Yes, ma'am. This is a very serious concern. It can't be overstated. If China gets a stranglehold on this, we're going to see similar activity to what they did earlier this year, it's my opinion, related to rare earth minerals.

95:35They could recreate the same type of scenario related to drugs, related to everyday household products that Americans need to survive on a daily basis. In addition to that, it's a domain that could produce 60 percent of the world's physical goods by the mid-century.

95:43So again, that just gives you the scale of it.

95:51Wow. Thank you.

95:54The biotech ecosystem is not just China and the U.S., and so there are other countries, but we don't want everybody to be relying on China. We want to – I think there's never going to be a non-China ecosystem.

96:06We wouldn't want that either, but it's going to – we want to make sure that we are not taking ourselves out of it. Amen to that. I yield back.

96:18One addition, if I may, that's very important here, and I know we're over time, so I'll short. The other aspect is the leadership. Whoever is in the lead gets to set the standards. Right now it's the United States.

96:27If we see that flip over to China, I forget which member brought it up earlier, is their way of doing business is much different than the United States. And so I think we could expect that to fold over into this area.

96:37I'm a big believer in setting standards and processes. Yes. Yeah. Thank you. I yield

96:42back. And the calorie has arrived. With that, I recognize Mr. Begich from Alaska.

96:47Thank you, Mr. Chair. My first question, Mr. Hodges, China passed us in total clinical trials in 2020 and in trials for novel medicines in 2023 and is on track to bring online newer industrial biomanufacturing capacity than the rest of the world combined.

97:01You say our lead is in the laboratory, not on the factory floor. What can this committee do and what can Congress do to move

97:15production to American soil? Phenomenal question, sir. This is the area where I think there's ready legislation to address this The committee is already moving several pieces to set the foundational layer here in America to restore some of that capability In addition to that we got to stop funding China and stop funding their biotechnology growth Right now, there's no laws prohibiting firms from actively investing in the sector.

97:40Last year, Congress passed outbound legislation. Biotechnology was not included in that. I believe it's under consideration this year. I would strongly recommend that that be considered. That would be an opening salvo that, again, would drastically address this.

97:53earlier in the testimony I stated that the other issue is regulatory. China holds – there's this thing that someone briefed me on recently where in China they've got a standing monthly meeting to address what can they do to help their bio firms outcompete the United States, a standing monthly meeting across cities to do this.

98:15Right now the United States is looking at this in months and years. They're trying to shave off days of their process. And so we've got a regulatory problem we've got to address.

98:23Thank you. Next question, Dr. Gromval, you have asked this committee to suspend the July 2026 policy on high-tech research, and your objection is to the vagueness of the definitions rather than to the prohibition itself.

98:35Do you support keeping the outright ban on dangerous gain-of-function research in place while Congress fixes the definitions?

98:45So thank you for the question, Congressman. That is a policy label that is kind of separate from the actual science that's going on. I think everybody wants safe and important research to continue, and it's just a matter of making sure that that has a pathway.

98:57The current policy doesn't have any exception process for work that is of clear public health importance, and we want to make sure that that work can continue and also that researchers are not, you know, shy about suggesting important work that has clinical benefits.

99:18Okay. Frontier developers evaluate their own models for biological risks today and there is no federal requirement that they do so or report what they find. You have advised those companies and been compensated for it.

99:33Tell the committee whether Congress can rely on voluntary commitments or whether that just lets the largest firms write their own internal rules.

99:43Thanks for the opportunity to clarify. I think that there is a lot of opportunity right now to be able to encourage the firms to share, like Anthropic did, what kinds of requests they're getting, and also to compare different ways to evaluate for biosecurity.

100:00It's such a fast-moving field, but I think it's still – there's still a lot that can – you know, I'm not worried about direct misuse yet. And so I think there's a great opportunity to be able to get to some better standards, encourage publication, so that eventually we have a better idea of what to regulate.

100:22I think one of the challenges that we have in Congress is trying to anticipate outcomes for industries that are not well understood within the body. I think that what we saw during the COVID pandemic, what we're seeing right now in sort of frontier AI is a recognition that sometimes you may not get a second chance and that it is necessary for us to put safeguards in place that protect the American people and really the people of the world for technologies that have an asymmetric capability.

100:59And certainly I think that's an important part of being a member of Congress, is not just seeing what's in front of us, but seeing around the corner. That's where we need help from industry experts who understand, yes, that research is important and it's interesting and it can be game-changing, but we do need to think about the implications of what can happen when things don't go the way that they were planned.

101:21And with that, I yield back.

101:25And now I recognize Mr. Webster from Florida for five minutes of questions.

101:29Thank you, Mr. Chair. Mr. Hodges, in May of 2021, the CIS subcommittee held a hearing on COVID-19. My late friend and colleague, Bill Posey, asked witnesses about scientific indicators suggesting the virus could have originated from a lab.

101:49At that time that view was pretty widely rejected by the media and by Dr. Fauci and the social media platforms. So that though it turns out Congressman Bozzi was right and his concerns were well founded.

102:10Given what we know now how can we ensure

102:19that gain research is never misused in the future Yes sir Part of this gets back to my original testimony which is we need to have better intelligence gathering methods related to biotechnology We have things in place for nuclear, we have things in space for space-based capabilities and a plethora of other areas, but we have very little in place related to the provision of existing dangerous pathogens and emerging new pathogens.

102:47And so I think that's step one. The other is increasing sort of oversight in this field. Again, as we outlined today, there is work that needs to be done for the United States to continue competing, in part to make sure that we are staying up to speed with our adversaries, but in addition to drive economic growth and development opportunities for Americans.

103:08And so I appreciate you raising this today. It's an issue that again puts a spotlight on one of the questions that I was raised at the very beginning, which is what's the status of where we are?

103:14And The status is there's a lot of work to be done. Past evidence shows that the old system was not working and we need things to improve it. And this again gets to the leadership question.

103:30We need someone who's in charge of the 15 agencies focused on biosecurity.

103:35There are unresolved questions about whether federal agencies properly applied oversight standards to foreign sub-recipients engaged in high-risk research, especially coronavirus research. In 2023, HHS Inspector General audit found that NIH did not effectively monitor certain awards and sub-awards to Echo Health Alliance.

104:02So, including about 1.8 million in subawards to eight foreign recipients, including the Wuhan Institute for Rhyology. What specific changes would you think the federal government needs to look at to ensure taxpayer dollars isn't misused at a high-risk pathogenic research oversight or overseas without any transparency or rigorous monitoring or anything like that, accountability.

104:44Yes, sir. Sorry. Particularly because some of those institutions and concerns were with China.

104:54Absolutely sir And I think the answer here is there a lot of bureaucracy in place that moves a lot of paper You need someone that accountable who you can call before this committee and other committees who is accountable to Congress and accountable to the executive on what's happening where and when.

105:13Right now it's spread out across not every but pretty close to every department and agency. And so the fact that this happened should be a wake-up call that we need to reform the system and fix it and have someone who can drive this forward, make sure we're not doing dangerous work where we don't need to be doing it, but also driving the science that we need to be doing here at home.

105:34Thank you very much.

105:39I would now recognize myself for five minutes of questions. It's interesting. I like to go last whenever I'm doing this because I like to kind of back clean up because I like to hear what everybody's asked and what you guys have answered so I can kind of get an idea.

105:52was brought up is that we have a decreasing number of applicants and people remaining here in the United States from foreign I assume Dr. Franz you're you were not born here or just you come from a weird part of Alabama with that accent I'm German I figured German so we actually are very excited to have people here from other countries who help us as mentioned you know a lot of our our highest functioning scientists come from other countries We've benefited from an immigration policy that allows us to take the best and brightest from all over the world, which I encourage.

106:27But I also want to point out the fact that our STEM program should be filled by Americans. There's no reason that we should have an education system that has a robust process. When you have 330 million people and you have all the assets that America has, a $30 trillion economy, and yet we're not producing enough scientists in America to fill a lot of these programs, we need a million, a million per year foreign students here in order to fill different programs because we don't have enough people who have the acumen or the interest in science.

107:00It's kind of egregious. And I would say since the American government got overly involved in education, we've seen a decline in the number of STEM students. We've seen a decline in the results. We've seen an increase.

107:14As a matter of fact, the largest inflationary increase in Americans' cost of living is education, since the American government decided to step in and make it better. The second highest inflation of course is health care which we also got involved with I would say we a big part of the problem right now and and when we talk about the distrust that we have why is the distrust why why this over burdensome process where it's getting harder to get grants harder to get funding why did that happen how did we get here i think it's pretty obvious uh kovid just accentuated it but when i don't think that in wuhan they intended to do what happened but it happened they requested the funds we said no you can't do gain of function but they did it anyways and it was funded by us i'm sure i was on the covet committee i'm an er doctor i've done the the conclusive analysis and i think it's pretty obvious what happened there's a deep distrust on who we're funding and why there's also a distrust on waste fraud abuse when we see hamsters in cages over the course of years being funded to what end and to what benefit to our society but at the talk that the taxpayers dollar and the people are kind of tired of it when we're spending over 30 percent in deficit and we're 40 trillion dollars in debt we're paying a trillion dollars in interest per year that's a problem and that's why oversight is very important when we talk about still stolen technology this has been going on for decades when you have over a quarter million Chinese students here the large part of them are gonna go back to China with what the technology that they learned in the leading institutions in America to go back and compete with us.

108:50There's a reason now that they have 50% of the AI studies students and studiers and developers. They have about 47% of the AI patents now. But where did that technology come from? Initially it came from right here in our universities where we trained foreign students to go back and compete with us.

109:11Same thing's true with biotechnologies. That's how we got here. Twenty years ago I was an adjunct faculty at Georgia Tech. I helped an investigation on a Chinese professor who was stealing from us back then.

109:22It didn't stop. It's only gotten worse. This is why we're here. Basically I think we need to protect our science. We make sure the next dollar doesn't fund the next Wuhan. To make sure that we're spending less on ideological programs that are predetermined, that we have peer-reviewed.

109:40I've seen scientific studies funded by by the government with a predetermined outcome, and then not peer reviewed, and then we call it science, and we pass it off, it doesn't matter, and we politicize science.

109:54Science should be blind. It should be the equivalent of truth, if you will. And when the government gets involved, a lot of times that gets skewed, and that's why we're here today. I think the people – we certainly don't want to have isolationism.

110:09I agree with you. I think we're not closing the door to the rest of the world. We're just finally checking who's coming through the door. I think that's very important. Mr. Hodges, we've talked a lot on policy.

110:23Obviously, China treats biotechnology as dual-use strategic technology. technology. We have collaboration with them, but we also have, obviously, competition. I'm worried. I watch James Bond movies where they're designing viruses to specific genealogies. Obviously, that's a thing now, and we can't stop it.

110:40That's already out of Pandora's box. What can we do now to protect ourselves by advancing our technologies as quickly as possible, but at the same time, making sure that the next leap in evolution and AI and science

110:55and development is done responsibly So it a very big question The first thing we can do is to make very clear to the Chinese and to other nations that attacks against Americans using bioweapons is absolutely unacceptable.

111:13That's something I think that the current administration has done and should continue to do. In addition to that, we've got to continue moving forward our intelligence capabilities in this field. repeatedly, but that's because it's desperately needed.

111:23And so I think I also just want to pause briefly and say your workforce bill that you're leading is essential. Right now, the part of the reason we need leadership is because we need people driving across the United States asking the question, saying, what are you doing to raise scientists?

111:40We've got space exploration that's on the table. We've got biotechnology. We've got AI development. If we're going to maintain that leadership, you're absolutely right. We have to have the the talent workforce. Your legislation does an incredible job at advancing that, so thank you for your leadership on it.

111:57But getting back to sort of the threat aspect of it there is an enormous room for diplomatic engagement there enormous room for scientific advancement to protect Americans against this Previously after 9 the anniversary was last week, I was thinking about this coming into the hearing today, the United States built up a vaccine related to smallpox to make sure that they could not use that against us, so that every American had it, so that our adversaries, if they tried to do it, but it would be useless.

112:24We can do the same thing.

112:25I'm about to gavel myself out here. But first of all, I want to point out that that bill that you mentioned that we submitted is a bipartisan bill. This is a bipartisan, this is a nonpartisan issue.

112:38This is a bicameral issue. This is something that matters for all Americans. I appreciate you all for being here today. I appreciate my counterparts for asking very inquisitive questions and wanting to get to the bottom of something that we're all accountable for.

112:52I appreciate everyone being here today. The record will remain open for 10 days for additional comments and written questions from the members This hearing is adjourned

113:23Yeah, yeah. That's great.

113:30Josh. How's it going? Andrew Donnelly. We met Adam. Stay in for a moment.

113:35That's right. Yeah.