Necessity and Implementation of Nucleic Acid Screening in the European Union
DNA synthesis plays a critical role in materializing designed proteins. However, as with all major revolutionary changes, this technology is vulnerable to misuse and the production of dangerous biological agents. - David Baker, Noble Prize winner 2024, in the Science Magazine
Illustration: DALL-E generated illustration, symbolic image for illustration purposes.
What is Nucleic Acid Synthesis technology?
DNA and RNA are formed of nucleic acids and are the building blocks of life. They provide a code which is then translated into parts of, or complete, organisms - such as a toxin that bacteria produce, or an entire virus.
Nucleic Acid (NA) synthesis technology enables the fabrication of DNA and RNA sequences on demand.
Companies can synthesize and deliver a wide range of sequences, including those found in nature, altered versions, or even completely novel designs.
This capability extends beyond universities and renowned institutions, as any individual can now cheaply order arbitrary NA sequences and have them shipped to them, or even purchase benchtop synthesizers - compact machines that allow for in-house DNA or RNA synthesis.
Why is it important?
While biotechnology offers transformative advances in healthcare, sustainable agriculture, and biomanufacturing - potentially generating $2-4 trillion in annual global value by 2030-2040 - this entire sector's progress and public trust could be shattered by a single incident of misuse.
What are the risks?
The primary concern lies in the dual-use nature of NA sequences. Without appropriate safeguards, synthetic NA technology could be misused to create dangerous pathogens or toxins that threaten:
Human health through engineered viruses and bacteria
Food security through agricultural pathogens
Economic stability through livestock diseases
Public trust in biotechnology research and development
The risk is amplified by increasing accessibility - NA sequences can be ordered online or synthesized using benchtop devices, potentially circumventing traditional laboratory safety controls. Harmful pathogens could be released – either deliberately or accidentally – potentially causing disease outbreaks and agricultural devastation.
What can be done?
Technology to screen sequences of DNA and RNA for potential malicious use exists. Grounded in existing EU priorities and legislation, we can design safeguards to ensure:
Know-Your-Customer: Customers ordering DNA or RNA are legitimate users.
Know-Your-Order: Sequences requested do not code for dangerous diseases or toxins, unless the organisation ordering them is doing legitimate research with appropriate safeguards in place.
Mechanisms for reporting and tracing suspicious requests.
Mechanisms are in place for verifying and certifying compliance.
EU Policy Options: What could this look like in the EU?
Current strategic priorities like the Political Guidelines 2024-2029 include national, social, health and economic security. Improving safeguards for NA synthesis technology would align with current initiatives, including the EU risk assessment of biotechnologies, the Chemical, Biological, Radiological and Nuclear Action Plan and the new EU Biotechnology Act.
There are several points at which safeguards could be integrated into EU policies:
Option: The EU can influence global landscapes by making EU and federal funding grants conditional on funding recipients only using synthetic NA providers that adhere screening standards. This would be in line with the US approach.
Option: Alternatively, safeguards could be integrated more deeply into frameworks combating terrorism (Directive 2017/541). In the action plan for CBRN security risks, the Commission has emphasised that terrorists can only carry out CBRN attacks if they have access to CBRN materials, and determined that access to high-risk CBRN materials must be more strictly controlled.
Option: A new high-risk biologicals approach could be designed to mirror the ‘high-risk chemicals’ framework.
Option: A Biosecurity Act could accompany the EU Biotech Act, bringing together different aspects of biosecurity into a unified framework.
Download the policy paper and the 2-pager:
For further information:
Laurent Bächler, Program Lead Biosecurity, Pour Demain info@pourdemain.ch