Washington, DC – Today, Congresswoman Julia Brownley (D-CA) announced Congressional action calling on the U.S. Office of Science, Technology, and Policy (OSTP) to issue strong guidance that mitigates risk and misuse of synthetic nucleic acids, a vital bio-material. Brownley’s effort was co-led by Representatives Dan Crenshaw (R-TX), Neal P. Dunn, MD (R-FL), Bill Foster (D-IL), Andy Harris, MD (R-MD), Sara Jacobs (D-CA), Rich McCormick, MD, MBA (R-GA), August Pfluger (R-TX), and Haley M. Stevens (D-MI), as well as Senator Edward J. Markey (D-MA), in a letter to OSTP Director Arati Prabhakar urging the agency to issue guidance to gene synthesis providers that will ensure safety, while promoting innovation.
“Given advances in biotechnology, common-sense oversight of synthetic nucleic acids has never been more necessary. There is the real possibility that things could go really wrong if a bad actor were to use these new biotechnologies to create a viable pathogen or other biological hazards,” said Congresswoman Julia Brownley. “Certain common-sense regulations, like screening customers before they can acquire synthetic nucleic acids, should be commonplace and can be fully implemented while supporting scientific and commercial research.”
“Gene synthesis is a valuable tool, accelerating scientific research and playing a key role in vaccine development, however, the rapid progress in gene synthesis technology also poses risks of misuse. President Biden’s Executive Order advances key safety measures for gene synthesis technology that I included in my ‘Securing Gene Synthesis Act’ with Congresswoman Eshoo. I will continue to work to pass this timely legislation, and I look forward to seeing these provisions from the Biden administration robustly implemented,” said Senator Edward Markey.
“The proliferation of AI in recent years has made it clear that it will impact every aspect of our society, including biotechnology. While it’s important we harness the potential of these technologies, we must also ensure proper systems are in place to protect against bad actors looking to abuse them,” said Congressman Bill Foster. “I’m proud to join my colleagues in urging the Office of Science and Technology Policy to quickly begin work on a gene synthesis screening framework, and I look forward to furthering safeguards for these risks on the House AI Task Force.”
“It is crucial that Congress takes necessary measures to prevent malicious individuals from using artificial intelligence to endanger our daily lives. As a member of the bipartisan A.I. task force, I am honored to join my colleagues in writing this letter to address and safeguard our nation’s health security,” said Congressman Rich McCormick.
“The integration of AI in biology offers unique opportunities to transform patient care and medical innovation,” said Congressman August Pfluger. “However, we must remain prepared against potential misuse by bad actors. I am proud to join my colleagues in this letter to the Biden Administration, emphasizing the urgency of robust oversight and collaboration to mitigate these risks effectively while ensuring that AI-driven advancements continue. As we navigate this complex landscape, my colleagues and I remain committed to finding the balance between fostering innovation and safeguarding against emerging threats.”
“Artificial intelligence has the potential to revolutionize biotechnology, however it also carries risks that must be addressed,” said Congresswoman Haley Stevens. “The recent actions by the Biden-Harris Administration are ensuring the U.S. continues to safely lead in the global AI-powered bioeconomy. The additional guardrails we propose in this letter, such as screening and international harmonization, are the next crucial steps to minimizing AI risks and maximizing its benefits in the biotechnology sector. And I look forward to further supporting the Administration’s effort to protect and bolster our AI bioeconomy.”
The letter is also supported by thirteen organizations and companies including Aclid, Battelle, Center for AI Policy, Centre for Long Term Resilience, Engineering Biology Research Consortium, Georgetown Center for Global Health Science and Security, Ginkgo Bioworks, Institute for Progress, Johns Hopkins Center for Health Security, Nuclear Threat Initiative | bio, RTX BBN Technologies, Inc., Technologies for Pandemic Defense, and Twist Bioscience.
“DNA synthesis is a powerful, fundamental tool for basic and applied bioscience research. Because DNA synthesis technology provides tremendous benefits but also could pose significant risks if misused, it will be critically important for the U.S. Government to play a leadership role in setting global standards for safeguarding this technology,” said Jaime Yassif, Vice President for Global Biological Policy and Programs at the Nuclear Threat Institute.
“We are in full support of the Biden Administration’s directives to departments and agencies to mitigate risk and reduce misuse of synthetic nucleic acids. Responsible development and use of this technology is a critical catalyst for the bioeconomy, making genetic engineering more accessible and safer,” said Kevin Flyangolts Founder and CEO of Aclid.
“This bipartisan letter on the need for common-sense screening of synthetic nucleic acid orders and customers addresses a key check-point in providing oversight of emerging artificial intelligence and biotechnology risks without bottlenecking innovation,” said Dr. Jassi Pannu, Senior Biotechnology Fellow at the Institute for Progress.
The full text of the letter can be found here and below.
The Honorable Arati Prabhakar
Director, Office of Science and Technology Policy
Executive Office of the President
1650 Pennsylvania Avenue, NW
Washington, DC 20504
Dear Director Prabhakar:
We write regarding the Biden Administration’s Executive Order (EO) 14110 on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. In particular, we support the EO’s directives to departments and agencies to mitigate risk and reduce misuse of synthetic nucleic acids, including by the development of a screening framework and federal purchasing restrictions (4.4. Reducing Risks at the Intersection of AI and CBRN Threats). Given advances in biotechnology and the proliferation of high containment labs, common-sense oversight of synthetic nucleic acids has never been more necessary.
We encourage the Office of Science and Technology Policy to develop the framework required by the EO effectively and without delay. In our view, effective implementation would include investments in the resources necessary to support gene synthesis screening, biannual reporting from confidential stress-testing, and international harmonization of screening efforts.
Recent statements by the Administration articulate the view that the United States must “seize the tremendous promise and manage the risks posed by Artificial Intelligence (AI) and protect Americans’ rights and safety.” The recent EO highlights key elements that are essential for studying and understanding the risks that AI poses in the context of Chemical, Biological, Radiological, and Nuclear (CBRN) defense.
Advances in our ability to synthesize DNA have been critical for scientific progress. DNA synthesis facilitates fundamental biology research and lifesaving drug development. However, recent advances in biotechnology and artificial intelligence tools have raised concerns about the reduced barriers to the de novo creation of viable pathogens starting with little more than digital information and an order of synthetic nucleic acids. While de novo synthesis is still not straightforward in practice, the screening of synthetic nucleic acids and the customers ordering them is a critical checkpoint, as it lies at the interface between a digital model providing sensitive pathogen information and a bad actor turning that information into a biological hazard. Despite the importance of screening synthetic nucleic acids, it is still not a universal practice, or well harmonized between different practitioners.
We applaud the ongoing efforts to reduce this risk, including the issuance of the updated Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids by the Department of Health and Human Services and the voluntary, proactive steps that gene synthesis companies have already taken, for example through international collaboration to apply a common protocol to screen customers. These efforts illustrate how DNA synthesis can be secured from misuse without impeding legitimate scientific or commercial research.
As a DNA synthesis screening framework is established, we are mindful of the importance of effective implementation, which should include:
- Investments in the infrastructure and resources necessary to support screening. There is a significant need for a confidential and secure federal sequence of concern (SOC) database to facilitate screening. Authority regarding the management and oversight of such a database should be clearly assigned, with relevant agency coordination. In addition, to prevent malicious circumvention, a secure industry database is needed that allows companies to share information about orders that raise alarms. Current efforts have had limited impact because they rely on bespoke private databases or ask companies to share too much proprietary information. Additional investment in customer screening and verification especially for international orders is needed, and could draw on the experience of banks in implementing the ‘Know Your Customer’ regime.
- Biannual confidential reporting from confidential stress-testing. Regular stress-testing exercises, including red-teaming (e.g. by having third parties attempt to order sequences of concern from nucleic acid synthesis companies), are critical to uncover vulnerabilities, reveal risks and improve the effectiveness of gene synthesis screening processes. The EO recognizes this and directs the Department of Homeland Security to lead such efforts. Stress-testing should also encompass rigorous evaluation of gene synthesis equipment, including benchtop synthesizers, alongside a comprehensive assessment of the cybersecurity measures and practices of organizations involved in synthesis. Stress testing in consultation with members of the intelligence community would ensure that such testing was informed by the best assessment of the threat landscape.
- International harmonization of gene synthesis screening via dialogue including with our strategic allies and relevant non-government organizations. Although many gene synthesis companies have voluntarily adopted screening practices, a lack of international harmonization is by far the most common concern that companies have highlighted. United States leadership in the development and harmonization of standards across borders is in our national interest. Screening domestic and international orders is important for national security and no United States company should be competitively disadvantaged by participating in screening. Ensuring that standards are harmonized across borders makes it easier for companies to comply and is crucial to prevent incidences of misuse and protect our nation’s bioeconomy. Over the long term, a broader international approach to DNA synthesis screening is likely to be most effective.
As the agencies consider these recommendations, we urge them to consult with external technical experts, industry leaders, and other stakeholders who have produced thoughtful guidance on this topic.
We thank you for your service in promoting our nation’s health security and request a briefing at your earliest convenience on OSTP’s planned actions in support of the Executive Order related to gene synthesis screening. We look forward to your timely response.
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Issues: 118th Congress, Healthcare