MEETING OF THE STATES PARTIES TO THE CONVENTION ON THE PROHIBITION OF THE DEVELOPMENT, PRODUCTION AND STOCKPILING OF BACTERIOLOGICAL (BIOLOGICAL) AND TOXIN WEAPONS AND ON THEIR DESTRUCTION BWC/MSP/2008/WP.3 3 December 2008 ENGLISH ONLY 2008 Meeting Geneva, 1-5 December 2008 Item 7 of the agenda Consideration of oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential of use for purposes prohibited by the Convention IASB Code of Conduct (Draft) Submitted by Germany 1. IASB is the Industry Association of the five leading German companies in the field of Synthetic Biology. The members of IASB share the same perspectives on biosafety and biosecurity with the aim to set the foundation for the secure and responsible development of their activities. The IASB Code of Conduct (Draft) demonstrates clearly IASB s interest and activities to play its role as a responsible actor in the field of Synthetic Biology. IASB Code of Conduct (Draft) Preamble 2. The field of Synthetic Biology is gaining momentum in the academic world. In parallel, a market for Synthetic Biology products and services has developed and grown rapidly over the past ten years. The Industry Association Synthetic Biology represents a number of companies and organizations with a stake in Synthetic Biology, for instance as providers of DNA synthesis or bioinformatics products. 3. IASB has created this Code of Conduct, which is to be implemented by each member, in order to secure the foundations of this fledgling field against abuse and to bring Synthetic Biology to its full potential. GE.08-64446
Page 2 4. IASB's activities are exclusively focused on exploiting the highly beneficial potential of synthetic constructive biology and biologically inspired structural and productive nanotechnology, its application and dissemination. 5. The most fundamental tools for the design of Synthetic Biology applications are synthetic genes and their intrinsic features of freedom of design and artificial biological function. 6. This Code of Conduct helps companies that provide DNA synthesis services and products to conduct their business in a sensible and responsible way. Declaration: The Industry Association Synthetic Biology herewith declares that it is in full agreement with the need for a safe and responsible use of synthetic DNA. IASB strictly follows all regulations and international standards designed to safeguard against intentional or unintentional abuse of synthetic DNA. General considerations 7. Synthetic Biology provides the means to accelerate the assembly of complex biological networks and to rapidly create biological entities with new properties. These powers will undoubtedly lead to a number of beneficial developments such as sustainable biofuels, new therapeutics and and biodegradable plastics. 8. However, the efficiency and power of Synthetic Biology can also create the potential for abuse. Through rapid DNA synthesis, biorisk-associated genes such as toxin genes or virulence factors become accessible to a large number of users. 9. In order to contain the risks of Synthetic Biology and to protect the field against misuse, the members of the Industry Association Synthetic Biology have adopted this Code of Conduct which provides guidelines for safe, secure and responsible commercial DNA synthesis. 10. One important consideration of any regulation for biosafety and biosecurity is the freedom of research: A lot of beneficial developments would be impossible without the freedom to explore organisms and genes that bear a certain environmental or health risk. It is our conviction that such a risk can be managed and contained in a secure manner, while at the same time ensuring the level of freedom that is necessary for desired scientific advancements. 11. It is our declared intention to raise barriers for malign attackers through a number of measures that combinedly will protect Synthetic Biology from abuse. We aim at encouraging continued improvements and harmonization in this field. 12. IASB will participate in the definition and setup of international standards for Synthetic Biology. It will promote the field by building a positive image of its potential and benefits. To this end, IASB will promote and showcase positive examples of Synthetic Biology applications. Risk assessment and risk management
Page 3 13. Abuse of synthetic genes in hazardous applications is possible in two ways only: Intentionally, and by failures in risk assessment and management. 14. The technology of handling synthetic genes uses complex procedures which by their nature are self-contained and tightly controlled under existing standards of good practice. 15. Therefore IASB follows existing risk assessment and management concepts based on established good practices and standard operating procedures. These procedures on a level comparable to ISO norms integrate analyses and control of internal and external risk factors of biosecurity and biosafety. 16. For biosecurity, risk assessment entails the screening of DNA sequences for genes which can be intentionally abused in biohazardous applications such as terroristic activities, whereas risk management entails the restriction of access to synthetic DNA to legitimate users. 17. For biosafety, risk assessment entails the analysis of potential hazard created by newly assembled biological pathways and components. Risk management is mainly concerned with issues of traceability on the level of labeling and containment. Record keeping 18. Records of suspicious inquiries and positive screening hits will be kept. 19. Statistics on biosecurity- and biosafety-related inquiries and orders will be kept. Cooperation with Authorities 20. Authorities will be informed about inquiries and orders that clearly indicate illegal activities, such as attempts at concealing a non-business delivery address. Customer Screening 21. Customers will be screened by determining their identity and affiliation and by ensuring that they and the organization they represent are legitimate users of synthetic DNA. 22. PO boxes and residential addresses will not be accepted as shipping addresses. 23. Addresses of businesses and institutions will be verified, and ensured that the address owner is a legitimate organization (such as a registered business or an internationally recognized academic institution).
Page 4 Sequence Screening 24. DNA sequences submitted as inquiries or orders for DNA synthesis by customers will be screened for homology with biorisk-associated genes. 25. Screening will be done on the DNA and protein level. 26. Screening will be against (i) (ii) All Australia Group biological dual-use organisms The Select Agent list (iii) National organism lists for export control or biological safety / security protocols. 27. For bacteria and eukaryotes, screening will be performed against all known genomic and plasmid transcripts. 28. For viruses, screening will be performed against all known genomic sequences. 29. For toxins, screening will be performed against the toxin gene sequences. Response to Identified Threats 30. When a homology against a gene in the screening database is found, the hit will be assessed by a molecular biologist or similar subject matter expert. 31. When the hit is deemed authentic, (i) (ii) the customer will be notified and made aware of the perceived risk the order will be accepted only if the customer is a legitimate user and all national and international regulations have been met. Cooperation on Biosafety and Biosecurity 32. Aspects of biosafety and biosecurity will be excluded from competitive activities. 33. IASB members will work together and with other stakeholders in improving biosafety and biosecurity measures. 34. IASB members will promote international dialogue through their activities; in particular, IASB will organize meetings and workshops to bring together international stakeholders and to discuss upcoming threats and responses.
Page 5 35. IASB members will assemble a Technical Expert Group on Biosecurity (TEGB). This group will review current design and implementations of biosafety and biosecurity measures, and will propose and initiate improvements. Each member will nominate one representative to this group. Promotion of Science 36. The need for biosafety and biosecurity measures must be carefully balanced with the freedom of research. 37. A large number of projects relevant to public health and improved biosecurity rely on Synthetic Biology and DNA synthesis. This includes the development of vaccines and the elucidation of mechanisms of pathogenicity. Therefore, legitimate uses of biorisk-associated sequences must not be hindered, and in fact, must be promoted. 38. IASB will support education in the field of Synthetic Biology, with a particular focus on aspects of biosafety and biosecurity, and will make available educational material for this purpose.