Director: Drew Endy
Deputy Director: Megan J. Palmer

Mission and Goals
The Practices thrust works actively with all SynBERC researchers and partners to ensure that biotechnology is advanced so as to benefit all people and the planet. From summer high school student researchers to principal investigators and industry and government partners, we envision that each member of the SynBERC community can help to consider and develop leading examples of responsible synthetic biology in practice. The Practices thrust supports this mission through a diversity of activities, including training researchers, framing research problems, and actively engaging with public policy makers and regulators.

Specifically, the Practices Thrust has the following four aims:

Core Essentials

• Safety: Develop learning materials that enable the next generation of biological engineers – the second biotechnology generation – to engage with, improve, and lead best practice with respect to research and laboratory biological safety.
• Security: Partner with national regulatory and policy bodies to ensure that SynBERC projects and researchers are not having an immediate or long term net negative impact on US and global biosecurity.

Strategic Policy Initiatives

• Ownership, Sharing & Innovation: Conduct basic and applied research on exploring how property rights specific to the uses of genetically encoded functions might be best configured in support of advancing synthetic biology.
• Beyond Containment: Advance consideration and best engineering practice with respect to developing microorganisms for use outside controlled laboratory and industrial fermentation environments.

Gap Minding

• Identify and constructively bring forward existing or emerging gaps, needs, or issues regarding the practice of synthetic biology that would have negative public impacts if left unaddressed.

Community

• Foster and support a diverse community of scholars and practitioners who are working together to best advance synthetic biology.

A schematic representation of activities in the Practices thrust

Current and Ongoing Projects

Aim 1: Core Essentials - Safety & Security

SynBERC Biosafety Program
The SynBERC Biosafety Program aims to enable the next generation of biological engineers to engage with, improve, and lead best practice with respect to research and laboratory biological safety.

All SynBERC students and investigators must affirm that they follow federal safety guidelines involving recombinant and synthetic DNA research, overseen by the Department of Health and Human Services. These guidelines were updated in 2009 and again in 2011 to account for technical advances in synthetic biology. Two SynBERC investigators (Ron Weiss of MIT and Drew Endy of Stanford) served as ad hoc members of the Federal Recombinant DNA Advisory Committee to ensure that the new guidelines were comprehensive and practical. These guidelines cover not just SynBERC but all biotechnology research at institutions receiving US federal funding. Other nations also look to these US guidelines as a basis for their own regulations. SynBERC principal investigators will continue to work on ensuring that federal guidelines change in response to technical advances. We hope and fully expect that SynBERC students - part of the second biotechnology generation - will lead the advancement of research and laboratory biological safety, both in practice and in policy.

SynBERC Biosafety Leadership (BSL) Experience
SynBERC’s BSL Experience is a new initiative to encourage SynBERC student researchers to take an active role in examining biosafety issues in their own projects and in the broader field of synthetic biology. The initiative centers on a video series currently under development that is designed to inspire and enable the next generation of national and global leadership on matters of biological safety. The three-part video will examine 1) the historical context that led to current biosafety regulations and practices, 2) profiles of up-and-coming researchers encountering issues of biosafety as they seek to advance their own work, and 3) how young researchers can prepare to engage in the practice of leading on social and policy topics in biosafety. The video is scheduled for completion in spring 2012 and will be made available to the public on YouTube and other widely public avenues.

Safety and Security in iGEM
SynBERC is a major contributor to the International Genetically Engineered Machines competition (iGEM), the premiere undergraduate synthetic biology competition. iGEM Director and SynBERC investigator Randy Rettberg, with input from SynBERC's Practices investigators and external experts, has built a Practices program within iGEM that addresses both safety and security. The goal is to develop the values and practices of safety and responsibility that are prerequisite for technological advancement for the public good. For example, every iGEM team must complete a safety questionnaire that is reviewed by the iGEM Safety Committee. Any team that does not complete the safety requirements is disqualified from the competition, while teams with notable attention to issues of biosafety can be awarded a safety commendation. In addition, iGEM teams compete for a special Practices award that recognizes innovative approaches to examining the safety, security, social and ethical dimensions of synthetic biology. The Practices judging is led by SynBERC investigator Ken Oye (MIT), Todd Kuiken (Woodrow Wilson Center) and Piers Millet (United Nations Office of Disarmament Affairs). Through iGEM, SynBERC is able to educate a large number of students internationally about safety and security in synthetic biology.

Synthetic Biology in an Age of Security
SynBERC partners with national regulatory and policy bodies to ensure that SynBERC projects and researchers are not having an immediate or long-term net negative impact on US and global biosecurity.

• Federal Bureau of Investigation: Supervisory Special Agent Ed You, of the FBI Weapons of Mass Destruction Directorate Biological Countermeasures Unit, was apppointed to SynBERC Scientific Advisory Board in spring 2011. Agent You presented on biosecurity issues at the Fall 2011 SynBERC retreat. We plan to work together to develop means for identifying and addressing the challenge of dual-use research, which is defined as biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security.
• National Science Advisory Board for Biosecurity: Drew Endy has been nominated to serve on the US National Science Advisory Board for Biosecurity (NSABB), a federal advisory committee within the National Institutes of Health. NSABB was chartered to provide advice, guidance, and leadership regarding biosecurity oversight of dual use research. The NSABB provides recommendations regarding criteria for identifying dual-use research, principles and tools for the responsible communication of dual-use research, and outreach/education to the scientific community regarding security matters.

In 2009, SynBERC researchers Ken Oye and Gautam Mukunda (MIT) co-authored “What Rough Beast: Synthetic Biology and the Future of Biosecurity,” which assesses and predicts the offensive and defensive capacities that synthetic biology could help create. To maximize defensive and minimize offensive impacts of synthetic biology, the authors recommend community-based efforts, regulation and surveillance, further research, and the deliberate design of security and safety into synthetic biology projects.The Oye Group has also published two key pieces: principles for the safe and responsible practice of synthetic biology, and a summary of U.S. Federal guidelines, rules and regulations concerning synthetic biology.

Also in 2009, then-SynBERC investigator Paul Rabinow (UC Berkeley) co-authored a commentary in Nature Biotechnology arguing the need for a sustained, informed, and non-inflammatory dialogue among a diverse range of experts and non-experts, to take place as synthetic biology develops, to help negotiate the boundaries of what is socially acceptable science. Rabinow et al recommended preparedness activities such as on-the-ground tracking of the effects of synthetic biology research, or training in emergency response to biological events.

DNA synthesis and security
Although DNA synthesis firms have primary responsibility for developing coordinated mechanisms to prevent delivery of known harmful DNA sequences to bad actors, SynBERC researchers have participated in developing policy recommendations in this area. In 2007, Drew Endy co-authored a study supported by the Sloan Foundation to identify and analyze policy, technical, and other measures to minimize safety and security concerns about synthetic genomics without adversely affecting its potential to realize the benefits it appears capable of producing. In a 2007 Nature paper, George Church, Drew Endy and group of academics, industry executives and security experts separately proposed an oversight framework to address concerns over the security of research involving commercial DNA synthesis.

Aim 2: Strategic Policy

Ownership, Sharing & Innovation (OSI)
Uses of genetic functions are now typically protected and shared via a patent-based property rights framework.  However, new tools including advanced DNA synthesis, automated strain engineering, and associated technical standards are producing geometric increases in both the complexity of designer DNA systems and the scale of DNA parts sharing.  Many examples now exist wherein the existing patent-based ownership, sharing, and innovation (OSI) framework is either being ignored or simply breaking. There is a vital need to understand if and how property rights mechanics might be best applied or updated for synthetic biology in practice.

The Practices Thrust is launching a year-long project between Mark Lemley (Stanford Law School) and Drew Endy (Stanford Bioengineering Department) to investigate and make recommendations on intellectual property rights structures for synthetic biology. In January 2012 we will convene the first meeting of the SynBioIP working group, a collection of leading experts in intellectual property law and representatives from across various institutions who are facing property rights challenges in the development of tools and applications of synthetic biology.

Beyond Containment: Design, Testing and Demonstration for Biosafety
This project seeks to address biosafety risks before rather than after problems arise. It focuses on biosafety outside the laboratory setting, where accidental release from the laboratory may be anticipated and/or where physical containment is not an option. The first phase of work focused on assessment and governance of risks associated with a biosensor and early versions of rE.coli. (rE. coli is the generic name for an engineered version of E. coli -- the workhorse microorganism in academic biological research -- that has been modified to reduce its danger to humans and the environment.) The second phase of work will focus on more capable versions of rE.coli and move into synbio applications in either bioremediation or biofuels. Our future work may turn to applications in agricultural and living therapeutics. This project is designed to complement technical design work on safer chassis by Arkin, Church and Knight labs, and is being conducted in partnership with the rE.coli project and with external partners at the University of Edinburgh and the Woodrow Wilson Center’s Synthetic Biology Project.

Aims 3 and 4: Community Building and Gap Minding

Developing Communities to Mind Gaps in the Practice of Synthetic Biology

The SynBERC community brings together leading experts across many disciplines, and we envision that all members of this community can engage and lead in advancing best practices and policies for the future of biotechnology. We are creating and evaluating practical ways for diverse practitioners and stakeholders to work together to consider and respond to the ramifications of synthetic biology.  New venues and mechanisms are being established to identify and raise ‘gaps’ - issues, needs or concerns - in the practice of synthetic biology that require community wide attention. Through a variety of activities, we foster discussion and work on these gaps within the community, its partners and stakeholders with the goal of producing materials – both educational and policy-oriented - that can be used, and reused, within SynBERC and disseminated broadly. Highlights of our Community Building and Gap Minding Activities include the following:

• Listening Tour: Every year the Practices thrust leadership meets individually with all SynBERC labs, scientific and industrial advisory board members, as well as other partners and stakeholders in synthetic biology, to discuss opportunities and needs. These visits allow us to stay current on new and emerging questions and concerns that inform strategic work in the Practices thrust.
• Synthetic Biology Practices Working Group (SBPWG): The SBPWG holds ongoing open monthly forums in the Bay Area which bring together diverse stakeholders to discuss the ramifications of synthetic biology in areas such as safety, security, ethics, policy, and law, and how the community might best respond. More information can be found on their wiki.
• Gaps List: An ongoing objective of the listening tours and working group meetings is seeding, prioritizing and sustaining a list of ‘top gaps’ in the practice of synthetic biology. Gaps and the discussions they catalyze have played critical roles in informing and directing strategic work by the Practice thrust and our partners.
• Synthetic Biology Slam: To encourage wider community participation and leadership in discussions of how synthetic biology should develop, we host synthetic biology futuring workshops. The inaugural “Synthetic Biology Slam”, held at SB5.0, brought together diverse community members - academy, industry, policy and hobby - to share their vision (in 5 minutes!) for the evolution of the field and contribute to a collective roadmap for biotechnology development. Videos can be found here.
• Calls for Community Proposals: Anyone in the SynBERC Community is invited to propose projects within the Practices thrust. This has spawned new collaborative projects which more intimately connect laboratory research design with issues envisioned in real-world translation. For example, the Silver lab has partnered with the Woodrow Wilson Center to hold multi-stakeholder workshops exploring how design of a cyanobacteria chassis for carbon fixation and energy production should be informed by considerations of environmental release and economics of scale-up.
• Leadership Accelerator Program (LeAP): To foster leadership in advancing responsible practices, we are developing an intensive multi-day workshop (currently slated for August 2012) which gathers young investigators in synthetic biology alongside invited guest experts in areas such as policy, ethics, industry, economics and law. The workshop aims to develop an awareness of the history, current practices and ongoing/future challenges facing the positive development of biotechnology and equip practitioners with knowledge, skills, and connections to make broadly-informed choices about directing their future work. During the workshop, participant teams will propose paths to addressing interdisciplinary challenges in advancing the practice of synthetic biology, and produce materials to share their insights and recommendations. Please contact mjpalmer@stanford.edu if you are interested in participating or supporting the program.