Chapter 2. Beyond the Lab and Far Away: A View from Washington

Todd Kuiken

In the 1970 film Tora! Tora! Tora!, Admiral Isoroku Yamamoto exclaims, "I fear all we have done is to awaken a sleeping giant and fill him with a terrible resolve." This was in response to the successful 1941 attack on Pearl Harbor by forces of Imperial Japan. In spring 2013, a small project listed on Kickstarter that was part of the larger DIYbio movement awoke the US regulatory system with a dimly lit glowing plant. On May 7, 2013, The New York Times published "A Dream of Trees Aglow at Night", which exposed those not paying attention to the power of crowd funding and the possibilities, albeit even with a novelty product, of biotechnology and the DIYbio movement. As I opened the door to my office that morning, my phone was already blinking, the first message from a US Senator’s office wanting to know how this type of product could escape regulatory oversight. As I hopped in a cab on my way up to Capitol Hill to brief the Senator’s staff, all I could think about was the quote from Admiral Yamamoto. Glowing Plant’s ability to raise half a million dollars in such a short period of time and the perception that there was no oversight of the first release of a genetically engineered seed produced by “amateurs” caught the government off guard. The swift and immediate reaction from the Hill gave me the sense that the “sleeping giant” had been awoken.

Our conversation was based on how a project like Glowing Plant was perceived to have escaped regulatory oversight and whether the Coordinated Framework, a regulation written in the mid-1980s, was capable of dealing with applications that could come out of the DIYbio movement. Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the federal system for evaluating products developed using modern biotechnology. It established which federal agencies would have jurisdiction over a particular application in order to streamline the process for companies that could potentially fall under the jurisdiction of at least three federal agencies and no less than four federal laws: the Plant Protection Act; the Federal Insecticide, Fungicide, and Rodenticide Act; the Federal Food, Drug, and Cosmetic Act; and the Toxic Substance Control Act. The three main federal agencies responsible for regulating the safe use of genetically engineered organisms are the US Department of Agriculture, the US Environmental Protection Agency (EPA), and the US Department of Health and Human Services' Food and Drug Administration (FDA). As the ability to manipulate and design new organisms rapidly evolves, debates on whether the coordinated framework is suitable to regulate the changing face of biotechnology should continue. However, the issue around Glowing Plant is not whether the process it is going to use is regulated or not, but whether the government and general public are comfortable with “amateurs” being able to use these techniques. Glowing Plant challenges the status quo in a number of ways. First, it showed how a research project could be funded outside the traditional funding methods, how democratized access to biotechnology techniques could spur a new company with thousands of supporters, and how a project/product could be marketed and sold as an open source application. At the same time, it is challenging whether our governance structures can deal with fast-paced technologies, particularly when it comes to environmental release from products produced outside the traditional biotechnology industry.

Over the past few years, the citizen science movement has risen from a relatively unknown “underground” movement to receiving accolades from President Obama:

 

These videos show how students are imagining the future—classrooms that are fully accessible to classmates with disabilities; individualized learning platforms that you can carry around in your pocket. And that’s the kind of creativity and imagination we want all our young people to embrace. We cannot wait to see more of that innovative spirit later this year when we host our first-ever White House Maker Faire. We already have a White House Science Fair. This new event is going to highlight how Americans young and old—tinkerers and inventors—are imagining and designing and building tools and machines that will open our minds and power our economy.

 
  -- President Barack Obama

This type of exposure can be both good and bad, depending on your perspective. It could potentially open the doors to federal funding, increase the ability to acquire surplus or retired laboratory equipment, and enhance access to user facilities and government expertise. However, it also shines a brighter light on the community, which could increase scrutiny from regulatory agencies and exacerbate the myths that surround the DIYbio community. The movement is going to have to engage with those in the federal government if it wants to avoid knee-jerk regulatory actions based on misinformation and conjecture from a segment within the government that believes placing biology in the hands of the public is too dangerous and that the movement has nothing to contribute beyond becoming the next biosecurity threat. Anyone tinkering with and experimenting with biology raises legitimate biosecurity, biosafety, and environmental concerns. As the movement becomes more sophisticated in its scientific abilities, these concerns will continue to grow and the community should continue to address and adapt to these apprehensions.

The DIYbio movement, and the larger citizen science movement, presents an interesting dichotomy for the US government. On the one hand, it wants to support the movement in order to promote innovation; on the other hand, there are legitimate biosecurity, biosafety, and environmental concerns that raise public policy and public perception issues. Like it or not, the community has a spotlight on it, and while the movement has its supporters within the government, there are those who are looking for ways to limit its ability to flourish and, in some instances, shut it down completely. By engaging directly with the government, the community can build supporters, adapt to their concerns early, and control the narrative around DIYbio.