Home

On Revision of the Coordinated Framework for the Regulation of Biotechnology

This white paper provides responses to questions posed in the October 2015 request for comment on revision of the Coordinated Framework and offers recommendations on long term strategies to foster innovation while addressing potential risks. It divides into three sections.
Priority regulatory issues: This section treats issues of immediate concern, as defined by five questions posed in the October 2015 request for public comment on updating the Coordinated Framework. For each question, we provide a distillation of issues raised in public comments, highlight gaps in discussion to date, point to useful resources, and offer recommendations.
Long term strategies for responsible innovation: This section responds to Part II of the July 2015 memorandum on the scope of inquiry for review of U.S. biotechnology policy. We recommend a strategy of planned adaptation, with research designed to provide a scientific basis for public policy and with tools, procedures and schedules to foster systematic reevaluation of policies in light of changing understandings of benefits, risks, and social/economic context.
Appendix with Analysis of Public Comments: This section provides a more complete analysis of public comments by industry, the academy and civil society.

Access the paper here

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 

Regulate 'home-brew' opiates

Kenneth A. Oye, J. Chappell H. Lawson, & Tania Bubela
Nature, 18 May 2015

Writing in the journal Nature Chemical Biology, researchers at the University of California at Berkeley have announced a new method that could make it easier to produce drugs such as morphine. The publication has focused attention on the eventual possibility that such substances could be manufactured illicitly in small-scale labs. Political scientists Kenneth Oye and Chappell Lawson of MIT, along with Tania Bubela of Concordia University in Montreal, authored an accompanying commentary indicating the research community and the public require a fast, flexible response to the synthesis of morphine by engineered yeasts.

Access the article here

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Designing safety policies to meet evolving needs: iGEM as a testbed for proactive and adaptive risk management

Julie McNamara, Shlomiya Bar-Yam Lightfoot, Kelly Drinkwater, Evan Appleton and Kenneth Oye
ACS Synthetic Biology, December 2014

iGEM has spent the past decade encouraging teams to push their projects to the frontiers of synthetic biology. However, as project complexity increases, so too does the level of assumed risk. In the absence of a coherent international framework for evaluating these risks in synthetic biology, iGEM has recently engaged with the MIT Program on Emerging Technologies to develop a progressive approach for handling questions of safety and security. These two groups have worked together to create a rigorous screening program, acknowledging that a strengthened set of iGEM safety policies ultimately serves to expand, not contract, the universe of acceptable projects. This paper reports on the policy process evolution thus far, screening findings from the 2013 competition, and expectations for future policy evolution.

Access the paper here

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Proactive and Adaptive Governance of Emerging Risks:  The Case of DNA Synthesis and Synthetic Biology

Kenneth A. Oye
International Risk Governance Council, June 2012

Like conventional biological engineering, synthetic biology rests on revolutionary advances in DNA sequencing and synthesis technologies. Unlike most recombinant DNA work, synthetic biology seeks to do biological engineering with standardized biological parts, modularized design, and routinized methods of assembly. By emphasizing standardization and modularity, synthetic biologists seek to cut costs by permitting outsourcing, to reduce barriers to entry in advanced biological engineering by reducing requisite skill levels, and to extend the range of useful applications of biological engineering. This paper describes the emergence of security risks associated with DNA synthesis and synthetic biology and evaluates the international conventions, national guidelines, transnational protocols and voluntary actions that have evolved to govern those risks. It then extracts some more general lessons for governance of emerging risks from experience to date in this domain.

Access the paper here

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Regulating 'Gene Drives'

Members of the Program on Emerging Technologies (PoET) team are calling for thoughtful, well-informed, public discussions to explore the responsible use of gene drive technology in two recently published articles.

Imagine a scientific technique that would alter the genes of mosquitos to render them unable to transmit malaria. Scientists have made notable progress in recent years in editing the genomes of organisms, substituting in variants of certain genes; these variants could then propagate throughout a population. Gene drives are a method for spreading altered traits through wild popultations over many generations. Such gene drives could potentially prevent the spread of diseases, support agriculture by reversing pesticide and herbicide resistance in insects and weeds, and control damaging invasive species.

The concept of gene drives has been around for more than a decade but has remained theoretical due to technical limitations. However, with the recent development of CRISPR-Cas9 RNA technology, gene drives now represent a more realistic possibility. The benefits of such technology must also be weighed against its risks. The possibility of unwanted ecological effects and the likelihood of spread across political borders demand careful assessment of each potential application.

Access the articles by clicking on the links below:

 


Regulating Gene Drives
Kenneth Oye, Kevin Esvelt, Evan Appleton, Flaminia Catteruccia, George Church, Todd Kuiken, Shlomiya Bar-Yam Lightfoot, Julie McNamara, Andrea Smidler, & James P. Collins

     
Concerning RNA-guided gene drives for the alteration of wild populations
Kevin M Esvelt, Andrea L Smidler, Flaminia Catteruccia, George M Church

 

Press relating to the articles above:

 

     MIT Spotlight today – three questions interview with Oye on Science piece.

     Oye Podcast at Science Express

     Altering Genes In Wild Populations: Boon For Human Health? Or Darwinian Nightmare?

     Genetically Engineering Almost Anything

     Science News, US Researchers Call for Greater Oversight of Powerful Genetic Technology

     Genetic Engineering to the Rescue of Endangered Species?

     A call to fight malaria one mosquito at a time by altering DNA

     Proposed Gene Technology Could Alter Organisms in the Wild

     Protect Society from Our Inventions, Say Genome-Editing Scientists

     Site-specific selfish genes as tools for the control and genetic engineering of natural populations

     Scientists proceed with caution towards new gene mutation technology