S3: A Central Resource for Science,Safety,and Security

Abstract

During the past 50 years, biological science and technology have advanced with remarkable speed. These advances in science and technology have led to the creation of regulatory frameworks by governments and best practices and guidance by scientific organizations to address questions that have emerged. The frontiers of biological science continue to expand, and the scientific community is still grappling with questions about the need for more regulations and guidance in emerging fields. Even the term “life scientist” has changed as multidisciplinary research collaborations increase to include experts from other disciplines. These new communities of collaborators require different kinds of education and training about laboratory biological risk management (laboratory biosafety, biocontainment, and biosecurity). Given these challenges, collaboration between the US government and the scientific community is more critical than ever before to ensure a balance between regulation and research progress and to foster and reinforce the culture of responsibility in the life sciences. Creating a central information resource can encourage safety in the life sciences and foster informed discussion of emerging policies and regulations.

In May 2011, the US Government launched the S3: Science, Safety, and Security campaign (S3; www.phe.gov/s3). The goal of this effort is to provide the scientific community with a central source of information about laboratory biosafety, biocontainment, and biosecurity. The S3 campaign also seeks to raise awareness about laboratory biological risk management policies. The government has developed a broad array of regulatory and policy frameworks for ensuring the safety and security of research in the biological sciences, but government regulations, policies, and guidance documents can sometimes be challenging to locate, whether in print or online, and to interpret. To encourage compliance, improve US Government communication with the scientific community and make it easier for scientists to understand requirements and current regulations, the S3 campaign was developed to put a public face on these issues at a variety of science and technology meetings.

The S3 campaign is comprised of two interconnected outreach activities: the S3 website, which serves as the archive for information relevant to biological risk management; and face-to-face engagement with scientists and stakeholders during scientific meetings. Although the information available on the S3 website and provided at meetings focuses on US government regulations, policies, and guidance on laboratory biorisk management, the website can serve as an international resource for countries and organizations that seek similar information. Current traffic patterns on the S3 website indicate that users come from domestic and international locations, suggesting that the website is already serving a multidimensional purpose.

The S3 website includes information about select agents and the Select Agent Program, import and export control laws, requirements for transporting biological materials, and policy documents relevant to laboratory risk management processes and procedures. The variety of resources provided is intended to be useful to researchers in many fields as well as policy makers, administrators, and laboratory workers. By reaching out to a wide range of stakeholders, the site is intended to be a central resource for individuals who seek to improve their understanding of US government biorisk management regulations, policies, and guidance.

Encouraging Dialogue

The US government seeks collaborative, two-way conversations with the life sciences community to promote progress in the life sciences while preventing and deterring the potential misuse of life sciences research, and to share information and best-practice guidance on biological risk management. The US government is committed to working with life scientists to identify approaches for biological risk management that can sensibly safeguard their scientific activities while minimizing any negative impact on the progress of science. Through the S3 campaign, the government actively seeks the input of scientists and other stakeholders about the types of information that would help answer their questions and improve their understanding about biorisk management issues.

There are a myriad of regulations, policies, and guidance documents related to life sciences research, and different government departments and agencies within the US government have responsibility for the management and oversight of those regulations. Through discussions between federal representatives and non-government scientists, members of the scientific community have expressed interest in a simplified, streamlined mechanism for scientists to access and better understand the regulations, policies, and guidance. The S3 website aims to address these needs.

The government also seeks to help the life science community protect itself from the accidental or intentional misuse of the discoveries and products of biological research. One of the best ways to discourage and prevent these outcomes is to ensure the open discussion of social norms against actions that could lead to breaches in biosafety or biosecurity, activities encompassed by the concept of a “culture of responsibility.” Although having such conversations, whether encouraged by the government or not, seems like a simple solution, they are important for ensuring and improving the practices and procedures fundamental to laboratory biosafety, biocontainment, and biosecurity. The S3 campaign focuses on facilitating those conversations and providing useful resources that will make them easier to conduct.

Recent discussions of influenza research and the complexity of conducting public health research that has the potential for misuse make it clear that resources are needed to help scientists think about any biosafety and biosecurity concerns that their research might pose. The S3 website identifies many relevant resources, from presentations by the Select Agent Program, to links to the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA. The website also provides links to documents developed by the National Science Advisory Board on Biosecurity, which can provide a starting point for discussions about dual use research within laboratories, universities, or other organizations. The goals of providing these materials are to encourage, improve, and expand discussions of dual use research within the scientific community.

Based on early feedback from users of the S3 website, the government is working to improve the search functionality in ways that will allow users to retrieve information about specific microbes or biological agents. It should be noted, however, that the key to effective laboratory biorisk management does not depend solely on the identity of the biological agent(s) involved. Instead, it depends on a site-specific risk assessment of the laboratory protocols that will be used to conduct work with a particular agent. Several scientists specifically requested a central resource for regulatory information, such as export numbers, select agent status, and transportation requirements, organized by agent. This database is under development as an element of the S3 website. The database will provide a consolidated resource focused on microbes and biological agents and will include information from several government departments, including the Departments of Commerce, Health and Human Services, and Transportation. For example, if researchers want to know what they have to do to ship or receive Crimean-Congo Hemorrhagic Fever Virus samples, they will be able to search for that agent and discover the relevant regulations and guidance related to working with the agent. This requested addition should encourage use of the resources available on the S3 site and make it simpler to access necessary government information.

Conclusions

The S3 website will provide an evolving, central resource for the scientific community to access US government information about laboratory biorisk management and to help facilitate clear communication of the goals and requirements needed for the safe and secure conduct of scientific research and technology development. The government welcomes comments and requests for additional resources.