As synthetic biologists devise increasingly sophisticated technologies and produce increasingly novel plants and microbes, countries find themselves pondering how to adapt to a rapidly changing landscape in their efforts to protect human health and the environment.
Toward better coordinating the regulation of biotechnology products, the U.S. White House has been working over the last year with EPA, FDA and USDA – the three primary U.S. regulatory agencies concerned with biotechnology products – toward updating the Coordinated Framework for the Regulation of Biotechnology to clarify current roles and responsibilities, develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support these efforts. On September 22, the White House announced the results of its work in the form of two documents: a proposed Update to the Coordinated Framework for the Regulation of Biotechnology and a National Strategy for Modernizing the Regulatory System for Biotechnology Products. The UK House of Lords Science and Technology Committee in its December 2015 report ‘Genetically Modified Insects’ noted that EU regulations on GMOs could stifle innovation in certain areas of biotechnology, including GM insect technologies.
At SynBioBeta SF 2016, a diverse panel of regulatory officials and researchers working in the United States and other countries will discuss how they understand synthetic biology in their day to day work and how they are encountering regulatory or oversight mechanisms work for synthetic biology applications. Moderating the October 5 session will be Genya V. Dana, Senior Science Policy Officer in the Office of the Science and Technology Adviser to the Secretary of State, at the U.S. Department of State.
“Synthetic biology is a beautiful interdisciplinary space, a great concept that’s bringing together people from many disciplines – bioengineering, computer science, physics, and others — to better understand and manipulate biology,” she says. “But we have to ask what’s coming out of the other end in terms of actual applications? We may have gotten here more quickly and more cheaply and through collaborations with different people, but are these outcomes really anything different from what we have already produced? Before countries or policymakers jump to the conclusion that we need new regulatory regimes, we have to consider the possibility that what is already in place is adequate.”
“We don’t want to stigmatize new technologies and we don’t want to unjustifiably stifle innovation,” she adds. “We want to take a balanced approach to regulation that enables research and innovation to power our economy while at the same time being cognizant of potential risks to human health and the environment.”
Growing up on a small family farm in Mississippi, Dana discovered her love for science in high school. Trained in ecological risk assessment of emerging technologies and stakeholder engagement in risk governance, she holds a masters in public policy and a PhD in conservation biology from the University of Minnesota. In her role with the State Department, she advises on emerging biotechnologies and international policy issues, is a negotiator on science, technology and innovation in multilateral organizations like the United Nations, and works to advance science, technology and innovation for sustainable development with a focus on Africa.
Describing the session she’s organized as a “conversation starter,” Dana says her panel will offer “a diverse network of of people who can both serve as resources and provide slices of experience as to what’s happening in different countries and with different synbio applications.”
The panelists are:
Carrie McMahon, Consumer Safety Officer, US Food and Drug Administration. After earning her doctorate, McMahon began her federal career as an intern in the Emerging Leaders Program of the U.S. Department of Health and Human Services, an experience that led to her current FDA assignment. As a “Consumer Safety Officer” in the agency’s Office of Food Additive Safety, McMahon is part of a team of regulatory scientists that’s responsible for ensuring new food ingredients are safe and lawful. The focus of her work is on the regulation and safety assessment of “GRAS” (generally recognized as safe) ingredients as well as food from genetically engineered plants. As a subject matter expert, she meets frequently with representatives of industry and foreign governments interested in learning about regulation of food ingredients in the U.S.
Jack Newman, Co-founder, Zagaya. With a grant from the Bill and Melinda Gates Foundation aimed at producing a cure for malaria, Newman co-founded Amyris, Inc. in 2004 as renewable products company. In the role of chief science officer, he then went on to lead the company’s 100-plus research team. Today, Newman serves on the board of directors of the Biobricks Foundation and Zagaya, a public benefit company he co-founded to improve the human condition through technology and education. Newman has worked as a contractor to the U.S. Defense Advanced Research Projects Agency and continues the fight against mosquito-borne diseases through the development of new biotechnologies to eliminate mosquitoes that carry disease. Newman advises the Puerto Rico Research, Science and Technology Trust, a nonprofit working to control dengue fever and Zika in Puerto Rico.
Mark Segal, Senior Microbiologist, U.S. Environmental Protection Agency. Working in EPA’s Risk Assessment Division (RAD), Segal provides science support for the Toxic Substances Control Act Biotechnology Program and co-chairs an interagency Algae Working Group. He is a member of the interagency Biotechnology Working Group tasked to revise the U.S. Coordinated Framework for Regulation of Biotechnology, which provides the U.S. Government’s guidance on biotechnology oversight. He helped develop the original version, published in 1986. He is also part of the US delegation to the OECD Sub-Working Group on Micro-organisms of the Working Group on Harmonization of Regulatory Oversight in Biotechnology.
Marcelo Freitas, Embrapa, Secreteriat for International Affairs, Brazilian Agricultural Research Corporation. With a Ph.D. in microbiology from the Federal University of Minas Gerais (UFMG), Freitas began his career as a federal professor and currently works at the Brazilian Agricultural Research Corporation (EMBRAPA), offering the Brazilian government technical support in Biotechnology, Synthetic Biology (Synbio), Genetic Modified Micro-organisms (GMOs), Biosafety and New Breeding Techniques (NBTs). He is a member of several high-level bilateral working groups in biotechnology and participates in the discussion about biosafety and about access and benefit sharing in global forums. He was recently inducted as a member of the National Biosafety Technical Commission (CTNBio) of Brazil.
Boet Glandorf, Senior Risk Assessor at the Dutch GMO Office, National institute of Public Health and the Environment. After earning her doctorate in plant pathology and performing field trials with GM biocontrol bacteria for several years, Glandorf gained her current job at the GMO Office where she is responsible for the risk assessment of field trials and commercial release of GM plants in the EU for the Dutch Ministry of Environment. Among others, she was part of the EU technical working groups on new plant breeding techniques and participates as an expert in several working groups of the European Food Safety Authority with respect to the safety of GM products. She is part of the Dutch delegation for negotiations under the Cartagena Protocol and part of the Ad Hoc Technical Working Group on Synthetic Biology. She discusses aspects of environmental risk assessment of GMOs, synthetic biology and regulation on a daily basis with students, scientists, applicants and civil servants.