The US has implemented new regulations to crack down on the manufacturing and distribution of synthetic DNA amid concerns that it could be used to create a harmful pathogen. President Biden signed an executive order last fall to establish new safety and security standards for AI applied to biotechnology, and the recently released rules are a result of this order. Synthetic DNA allows for various biotechnological advancements, such as diagnostic tests and enzyme development. However, the ease and accessibility of synthesizing DNA raise concerns about the potential creation of dangerous viruses. The new regulations require DNA manufacturers to screen orders for sequences of concern and assess customer legitimacy in order to prevent the accidental or intentional release of harmful pathogens. While these rules only apply to federally funded entities for now, they represent a significant step forward in safeguarding against the misuse of synthetic DNA.
The Importance of Cracking Down on Synthetic DNA
The potential dangers of synthetic DNA
Synthetic DNA has the potential to be used in ways that could pose serious dangers to society. With the ability to create new gene sequences that do not exist in nature, there is a risk of creating organisms, particularly viruses, that could be harmful to humans and other living things. The ease, affordability, and speed at which synthetic DNA can be synthesized make it a concern for biosecurity and public health.
The need for new standards
Recognizing the potential dangers of synthetic DNA, there is a clear need for new standards to ensure the safety and security of mail-order genetic material. The recent rules issued by the White House are a step in the right direction, but there is still work to be done to expand these standards to cover all DNA providers, regardless of whether they receive federal funding.
The role of AI in DNA synthesis
Advancements in artificial intelligence (AI) have played a significant role in the synthesis of DNA. AI technology allows for the creation of entirely new gene sequences that do not exist in nature. While this has opened up possibilities for scientific research and innovation, it has also raised concerns about the potential misuse of synthetic DNA. The rules implemented by the White House aim to address these concerns by screening purchase orders and assessing customer legitimacy, with a specific focus on sequences of concern.
Concerns about de novo creation of organisms
One of the most significant concerns regarding synthetic DNA is the possibility of de novo creation of organisms, particularly viruses. With the ability to order genetic building blocks and assemble them into a whole pathogen, there is a risk of a bad actor intentionally or accidentally creating a dangerous virus. The reconstruction of the extinct horsepox virus using mail-order DNA highlighted the potential for recreating deadly diseases that have been eradicated. The new rules seek to prevent such scenarios by implementing screening practices and focusing on sequences of concern.
The New Rules by the White House
Overview of the rules
The new rules issued by the White House aim to establish standards for the safety and security of synthetic DNA. These rules require DNA manufacturers to screen purchase orders to flag sequences of concern and assess the legitimacy of customers. The focus is on preventing the creation of organisms that could pose a threat to humans or other living things. Currently, the rules only apply to scientists or companies receiving federal funding, but there is a call for broader screening mandates.
Screening purchase orders
One of the key requirements of the new rules is the screening of purchase orders by DNA manufacturers. This screening process aims to identify and flag sequences of concern that could contribute to an organism’s toxicity or ability to cause disease. By screening purchase orders, DNA providers can ensure that potentially dangerous sequences are not being synthesized and distributed.
Assessing customer legitimacy
In addition to screening purchase orders, the new rules also require DNA manufacturers to assess the legitimacy of their customers. This assessment helps to ensure that the genetic material is being provided to legitimate scientists or companies for valid scientific purposes. By verifying the legitimacy of customers, the risk of synthetic DNA falling into the wrong hands is reduced.
Focus on sequences of concern
The new rules place a specific focus on sequences of concern. These are gene sequences that have the potential to be harmful or pose a threat. By identifying and flagging sequences of concern, DNA manufacturers can prevent the synthesis and distribution of genetic material that could be used for malicious purposes.
Application to federally funded scientists/companies
Currently, the new rules only apply to scientists or companies that receive federal funding. This means that DNA providers who supply synthetic DNA to federally funded entities must implement the screening practices outlined in the rules. While this is a significant step forward, it does not cover scientists or organizations with private sources of funding. There is a need for broader screening mandates to ensure the safety and security of all synthetic DNA.
Existing Screening Guidelines in the DNA Industry
Department of Health and Human Services guidelines
The Department of Health and Human Services issued guidelines in 2010 that provide recommendations for the screening of synthetic DNA orders. These guidelines aim to prevent the misuse of synthetic DNA by identifying potentially harmful gene sequences. However, compliance with these guidelines is voluntary, and not all DNA providers adhere to them.
The International Gene Synthesis Consortium
The International Gene Synthesis Consortium is an industry group that has developed guidelines for the screening of synthetic DNA orders. About 80% of the DNA industry has joined the consortium and pledged to vet orders for sequences of concern. While this is a positive step, membership in the consortium and adherence to the guidelines are voluntary.
Voluntary nature of current measures
One of the limitations of existing screening guidelines is that they are voluntary. While many DNA providers follow the guidelines issued by the Department of Health and Human Services and participate in the International Gene Synthesis Consortium, compliance is not mandatory. This leaves room for non-compliance and raises concerns about the potential risks associated with synthetic DNA.
Concerns about non-compliance
The voluntary nature of current screening measures raises concerns about non-compliance within the DNA industry. Without mandatory screening requirements, there is a risk that some DNA providers may not implement adequate screening practices. This could potentially allow sequences of concern to be synthesized and distributed, increasing the potential dangers associated with synthetic DNA.
The Call for Broad Screening Mandates
Introduction of the Securing Gene Synthesis Act
In response to the need for broader screening mandates, a bipartisan group of legislators introduced the Securing Gene Synthesis Act. This legislation aims to mandate screening for all DNA providers, not just those receiving federal funding. The act would require all DNA providers to implement screening practices to prevent the synthesis and distribution of potentially dangerous gene sequences.
Advantages of broad screening
Implementing broad screening mandates would help ensure the safety and security of synthetic DNA. By making screening practices mandatory for all DNA providers, the risk of harmful gene sequences being synthesized and distributed would be significantly reduced. Broader screening would also help to level the playing field within the DNA industry, ensuring that all providers adhere to the same standards.
Status of the legislation
While the Securing Gene Synthesis Act has been introduced, it has yet to advance. The legislation is currently awaiting further action in Congress. However, the introduction of the act indicates a recognition of the need for broader screening mandates and a proactive approach to addressing the risks associated with synthetic DNA.
Response from DNA Providers
Importance of regulation according to Twist Bioscience CEO
The CEO of Twist Bioscience, a San Francisco DNA-synthesis company, recognizes the importance of regulation when it comes to synthetic DNA. DNA is considered dual-use technology, meaning it can have both positive and negative applications. Regulation is necessary to ensure the ethical use of DNA and to prevent misuse that could harm individuals or communities.
Current screening practices
Many DNA providers, including Twist Bioscience, have already implemented screening practices to prevent the synthesis and distribution of harmful gene sequences. Twist Bioscience has been screening sequences and customers since 2016. They have learned from past experiences and have enhanced their protocols to ensure thorough screening.
Lessons learned and protocol enhancements
Twist Bioscience’s screening processes have evolved over time as they have learned from their experiences. For example, they used to screen only DNA sequences that were 200 base pairs or longer. However, they now screen sequences that are at least 50 base pairs to prevent customers from ordering smaller sequences and assembling them together. These protocol enhancements demonstrate the commitment of DNA providers to prioritize safety and security.
Limitations of the New Rules
Exclusion of privately funded scientists/organizations
One limitation of the new rules issued by the White House is that they only apply to scientists or companies receiving federal funding. This means that privately funded scientists and organizations are not currently required to adhere to the screening practices outlined in the rules. This exclusion leaves a potential gap in the regulation of synthetic DNA and raises concerns about the security and safety of genetic material handled by privately funded entities.
Risk of state actors with their own gene synthesis capabilities
Another limitation of the new rules is the risk of state actors with their own gene synthesis capabilities. While the rules place responsibilities on DNA providers, there is the potential for state actors to develop their own gene synthesis capabilities. With vast resources at their disposal, these state actors may be able to bypass the screening practices implemented by DNA providers and create synthetic DNA that could be used for harmful purposes.
The Ethical Use of DNA
Recognizing DNA as dual-use technology
DNA is considered dual-use technology, meaning it has the potential for both positive and negative applications. While synthetic DNA has many beneficial uses, such as the development of diagnostic tests and treatments for diseases, there is also the risk of misuse that could harm individuals or communities. Recognizing DNA as dual-use technology highlights the importance of responsible and ethical use.
Responsibility to promote ethical use
As providers and consumers of synthetic DNA, there is a shared responsibility to promote ethical use. Following appropriate screening measures and adhering to regulations and guidelines helps ensure that synthetic DNA is used in a responsible and ethical manner. By prioritizing safety and security, the potential risks associated with synthetic DNA can be minimized.
The role of the scientific community
The scientific community plays a crucial role in promoting the ethical use of DNA. Researchers and scientists have a responsibility to conduct their work with integrity and to prioritize the safety and security of synthetic DNA. By sharing knowledge and best practices, the scientific community can collectively work towards ensuring the responsible use of synthetic DNA.
Screening measures to prevent misuse
Screening measures are an essential tool in preventing the misuse of synthetic DNA. By implementing screening practices, DNA providers can identify and flag gene sequences that could pose a threat. These screening measures help ensure that synthetic DNA is only used for legitimate scientific purposes and prevent the creation of organisms that could be harmful.
The Future of Synthetic DNA Regulation
The potential for future legislation
The introduction of the Securing Gene Synthesis Act indicates a recognition of the need for broader screening mandates and a proactive approach to addressing the risks associated with synthetic DNA. This legislation, if passed, would mark a significant step forward in ensuring the safety and security of synthetic DNA. Continued advancements in technology and scientific understanding may also drive the need for future legislation to keep pace with evolving capabilities.
Continued advancements in DNA synthesis
Advancements in DNA synthesis technology are expected to continue, making it increasingly easier, cheaper, and faster to synthesize genetic material. These advancements present both opportunities and challenges when it comes to the regulation of synthetic DNA. Ongoing efforts will be needed to ensure that regulations and screening practices keep pace with advancements in technology and continue to effectively address potential risks.
Ongoing efforts to address potential risks
Efforts to address the potential risks associated with synthetic DNA are ongoing. The introduction of new rules and the proposed legislation demonstrate a commitment to proactive regulation and the recognition of the importance of biosecurity. Continued collaboration between government agencies, DNA providers, and the scientific community will be essential in addressing potential risks and ensuring the responsible use of synthetic DNA.
International collaboration and standards
Biosecurity and the regulation of synthetic DNA are global concerns. International collaboration and the establishment of standards are essential in addressing these concerns effectively. Collaborative efforts can help ensure that regulations and screening practices are consistent across borders, reducing the risk of synthetic DNA being misused or falling into the wrong hands.
Conclusion
The proactive regulation of synthetic DNA is of utmost importance to ensure the safety and security of society. The new rules issued by the White House and ongoing efforts to address potential risks are steps in the right direction. Balancing scientific progress with safety and security is crucial, and ongoing vigilance is needed to adapt to evolving capabilities and potential risks. By recognizing the importance of screening measures, promoting ethical use, and fostering international collaboration, society can leverage the benefits of synthetic DNA while mitigating potential harm.
Source: https://www.wired.com/story/synthetic-dna-us-biden-regulation/