France currently has some of the world’s most clearly-defined regulation on synthetic nucleic acids. In December 2024, IBBIS and the Paris Peace Forum brought together experts for a French-language roundtable on DNA synthesis screening at the Maison de la Recherche, Paris. The discussion explored how biosecurity safeguards can be integrated into the bioeconomy.

France has shown significant recent leadership on regulation to safeguard the bioeconomy, including its framework for Protecting National and Scientific Technical Potential (PPST), which protects knowledge that could contribute to WMD proliferation, and recent updates to its national regulation of hazardous microorganisms and toxins (MOT) under the public health code.

A key update in relation to DNA synthesis screening is an order issued on April 26, 2023 that made significant updates to the MOT list. The order’s Annex B (as translated by IBBIS), clearly defines controls on synthetic nucleic acids from the listed organisms as follows:

a) For the smallpox virus (Variola virus), any genetic fragment, whether of natural or synthetic origin, provided its sequence exceeds 500 base pairs

b) For other viruses, any genetic fragment, whether of natural or synthetic origin, provided that:

• its sequence exceeds 800 bases (or base pairs)
• and the translation of the sequence, direct or indirect, exceeds 75% of the amino acid sequence of a viral protein

c) For bacteria, any genetic fragment, whether of natural or synthetic origin, provided that:

• its sequence exceeds 500 bases (or base pairs)
• and its sequence is derived from one of the following genes:
  • CapA, CapB et CapD, encoding the capsule of Bacillus anthracis;
  • Cya, encoding the Edema factor (EF) of Bacillus anthracis
  • Lef, encoding the Lethal factor (LF) of Bacillus anthracis
  • PagA, encoding the protective antigen of Bacillus anthracis
  • BoaA et BoaB, encoding the adhesins of Burkholderia mallei and B. pseudomallei
  • bopC, encoding a part of the type III secretion system of Burkholderia mallei or Burkholderia pseudomallei
  • wcbE, wcbF, wcbG, wcbH, wcbI, wcbJ, wcbK, wcbL, wcbM, wcbN and gmhA coding part of the capsule of Burkholderia mallei or Burkholderia pseudomallei
  • recO, encoding a methyltransferase of Rickettsia prowazeki
  • Pla, encoding a protease of Yersinia pestis;
  • Any genes encoding botulinum toxins, excluding those derived from  Clostridium botulinum type C, D, C/D, and D/C

The order is clear that any work involving listed microorganisms or toxins, including the nucleic acids described in Annex B, must comply with the regulations outlined in the Public Health Code, which include obtaining proper authorizations and adhering to safety protocols to prevent misuse or accidental release. Ensuring these authorizations are in place essentially requires synthesis screening for any synthetic nucleic acids that fall within the sizes regulated by the MOT.

Despite existing biosecurity efforts, the roundtable identified some gaps, including a lack of mandatory training on the potential misuse of science. Many researchers are not required to undergo formal education on dual-use risks, leaving critical blind spots in awareness and prevention. Strengthening training requirements could help close these gaps and ensure a more secure scientific landscape. Additionally, regulatory inconsistencies pose challenges, particularly in export controls for microorganisms, toxins, and genetic material. Experts emphasized the need for harmonized approaches to avoid regulatory gaps and strengthen oversight.

Key topics discussed at the Paris roundtable:

• The role of DNA synthesis screening in implementing international obligations like the Biological Weapons Convention and the UN Security Council Resolution 1540.
• The need for harmonized European regulations to address biosecurity gaps.
• Advancing scientific oversight by focusing on protein function rather than just genetic sequences when it comes to screening approaches.
• Strengthening cooperation between scientists, regulators, and policymakers to foster trust and safe innovation.

Learn more:

You can learn more about the referenced frameworks here:

• Order updating the MOT with specifics on coverage of nucleic acids / genetic elements: Arrêté du 26 avril 2023 fixant la liste des micro-organismes et toxines prévue à l’article L. 5139-1 du code de la santé publique.
• MOT articles in the Code de la santé publique: Chapitre IX : Micro-organismes et toxines. (Articles L5139-1 à L5139-3)
• Dispositif de protection du potentiel scientifique et technique de la nation (PPST) framework.

As well as reading a summary of the French biosecurity regulatory landscape on the BWC Implementation Measures database.