Supporting Responsible Research Through Comprehensive Biosecurity
Researchers use synthetic DNA and synthetic biology tools to modify existing natural biological systems for useful purposes. The benefits of synthetic biology are many and profound, and provide important tools to develop new therapies and cures for diseases, renewable non-fossil fuels, alternative methods of chemical production that do not contribute to global warming, as well as agricultural crops that fertilize themselves and are disease resistant. While new tools such as CRISPR/Cas9 and TALENs have expanded the availability and use of synthetic biology, scientists began engineering biological systems using recombinant DNA more than 40 years ago, resulting in important medicines such as insulin and human growth factor.
Twist Bioscience provides synthetic DNA, in the form of oligonucleotides, genes and libraries, that accelerate responsible research across a wide range of applications – from biomedical research to data storage, agriculture to biodefense. With the tremendous promise of this technology comes great responsibility. As such, we have invested considerable time and energy to build and operate a comprehensive biosecurity program composed of six key components.
National and International Regulations
We perform rigorous biosecurity and export control screening to ensure that order fulfillment is consistent with all legal and regulatory guidance. This guidance includes the U.S. government Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, the regulations and policy guidance in the U.S. Federal Select Agent Program (FSAP), and the International Gene Synthesis Consortium’s Harmonized Screening Protocol. In addition, as Twist Bioscience manufactures DNA in the U. S., the sale of synthetic DNA is subject to compliance with the U.S. Department of Commerce Export Administration Regulations (EAR) which define biological sequences that require a license prior to export from the U.S.
Screening of Sequences and Customers
We screen all double-stranded DNA sequences ordered to determine whether they are a portion of an organism deemed to be controlled either domestically or internationally. These controlled organisms include smallpox, dangerous strains of Avian influenza and other pathogens that pose a significant threat to animal, plant or human health. Possession of these controlled organisms is highly restricted and regulated.
If a controlled sequence or a portion of a controlled sequence is detected during our screening process, we stop the order process immediately if the customer does not have the credentials to receive the sequence. As standard practice, we do not ship a controlled sequence, unless the customer provides documentation of correct and complete licensing before completing the order. In addition to sequence screening, we screen each customer to help ensure that they are not included on any government watch lists including the Specially Designated Nationals list and the Denied Persons List and that they are not listed as sanctioned by the Department of State. We also confirm the validity of each of the organizations to which we sell. Finally, we require all customers to agree not to resell DNA produced by Twist Bioscience except under specific contract to do so. We will not conduct business if there is an indication that a customer would resupply a sequence.
We have allocated personnel resources to ensure that employees follow all policies and procedures associated with our biosecurity program and to address any concerns that may arise. This includes a Trade Compliance Manager, a Screening Manager, and a Biosecurity Response Team.
All employees of Twist Bioscience are trained at least annually on the policies and procedures required for trade compliance and biosecurity protocol within the organization.
We maintain relationships with several governing and industry bodies to address areas of concern, including the Federal Bureau of Investigation, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture’s Animal and Plant Health Inspections Service, as well as our industry trade group, the International Gene Synthesis Consortium (IGSC), whose members manufacture more than 80 percent of the world’s synthetic DNA. Of note, all IGSC members notify other group members of any suspicious orders received to prevent venue shopping.
Our internal policies require that we maintain documentation for each biosecurity screening of an ordered sequence for eight years.
We acknowledge that biosecurity and the best practices required to maintain safe access to synthetic DNA will evolve continually as our understanding of biology increases. In addition, we believe that life sciences research has the potential to improve public health surveillance, enhance emergency preparedness and aid response efforts. As such, we encourage flexible governance for emerging concerns as new information or shifting dynamics require.
We engage in active dialogue with leading experts to help ensure Twist Bioscience screening meets or exceeds best practices. As part of this drive to innovate, we are participating in the Intelligence Advanced Research Projects Activity Functional Genomic and Computational Assessment of Threats program. This program aims to develop a suite of next-generation computational and bioinformatics tools that will help all DNA synthesis companies build upon and strengthen their current protocols. Additionally, we participate in the FBI’s International Biosecurity and Prevention Forum, an open forum to discuss biosecurity and communicate with stakeholders at all levels of government, industry and academia.
While these policies and procedures require both time and monetary investment from Twist Bioscience, we are committed to accelerating scientific research to improve lives worldwide. Synthetic biology holds great promise for improving human health and the global environment. We are proud to provide high-quality synthetic DNA that will help realize this promise, while also conducting disciplined biosecurity screening to help maintain public safety.