Washington Lawyer

The Rise of DIY Scientists: Is It Time for Regulation?

From Washington Lawyer, May 2012

By Sarah Kellogg

Illustration of a strand of DNA. Illustration by Ron Flemmings.Emerging science has long presented government with critical if problematic policy choices. In the early stages of most promising new research, it makes no sense to weigh scientists down with punishing regulations that could smother “the next big thing.” Yet if government isn’t actively monitoring the process, or if it delays implementing regulations to govern the safety of materials and practices used in research, it could be setting the stage for disaster.

This is where the government finds itself with do–it–yourself (DIY) biology, a movement populated by hobbyists and after–hours lab techs hoping to make scientific breakthroughs in their home–based laboratories. Like its professional counterpart, the DIY science community contends that true innovation only comes when entrepreneurial thinkers are able to exercise their intellectual muscles in genuine freedom, and without the prying eyes of the eternally suspicious federal government.

So far the DIY science movement has won the regulation–versus–freedom argument. There are few rules on the government’s books that directly govern DIY practices. The assumption from government regulators is that amateur scientists won’t be working with materials that can do much harm to the public or the environment. Plus, it’s impractical to regulate a dispersed industry that’s akin to home woodworking and gardening, albeit with more far-reaching economic and educational potential.

“There are many who want a strong regulatory approach to this kind of technology, but when outfitting a lab costs a few thousand dollars off eBay, plus the minimal time required to assemble the stuff, what do you do?” says Robert Carlson, the physicist and bioentrepreneur who founded the Seattle biotechnology firm Biodesic. “People can also build equipment after a quick trip to the hardware store now and order on the Internet all the enzymes and other chemicals they need. If that’s the world we live in, how do you try to prevent access? You’ll only create a situation where people are afraid of the authorities, so they’ll do it behind closed doors. That is far more dangerous because [the authorities] may not know when [DIY scientists] are about to do something dangerous.”

With that in mind, the federal government and local government agencies have engaged the DIY community in a painstakingly constructed education and outreach strategy. Certain that a hostile approach would drive amateur scientists even further underground, government authorities have held off regulating bio hobbyists and the research they undertake in their basements or garages.

Moreover, the scientific community has urged regulators to err on the side of scientific autonomy, saying there are enough protections on the books to ensure the nation’s safety and security. Critics, however, say this approach suggests that DIY biologists are immune to the unintended consequences posed by complex biotech lab work, and it fails to recognize that it is not a question of if an adverse event will occur, but when.

“The access to knowledge to conduct these kinds of experiments is much greater now, infinitely greater, than it ever used to be,” says Lawrence O. Gostin, the Linda D. and Timothy J. O’Neill Professor of Global Health Law and faculty director of the Center for Law and the Public’s Health at Georgetown University Law Center. “Much of the information about these harmful agents is available one way or another on the Internet. In the past, you needed to be a reasonably high–level scientist with access to scientific journals and a core set of skills to do this research. Now, those natural inhibitors or boundaries are not present. The knowledge to do harm is ubiquitous.”

With the near-certain expansion of DIY biology in the next few years, the government’s cooperative policy may be difficult to maintain. All agree it is inevitable that something will happen in a community- or home–based lab that will prompt a round of rulemaking after the fact. Most likely the incident will be an accident, such as pouring some questionable substance down the basement drain, and not a deliberate act of terrorism. Either way, such an event is bound to trigger a wave of recriminations and public calls for legislative action.

In this sense, the government’s approach to the DIY biology movement is instructive for emerging science in the 21st century. It offers an illuminating blueprint on how to encourage scientific discovery and innovation while also shielding society from the dangers that can come with unexamined and unrestrained scientific inquiry. Ultimately, the current collaborative system adopted by government agencies could illustrate how best to handle potential biosafety and biosecurity issues within the scientific community for years to come.

Arrival of Synthetic Biology
Amateur biology labs are the rage among science hobbyists due largely to the advent of synthetic biology, a relatively new field of scientific research and discovery. By combining techniques associated with both science and engineering, synthetic biologists use either unnatural molecules “to mimic natural molecules” to create new life forms or natural molecules to redesign existing life forms. What is especially appealing about synthetic biology is its interdisciplinary nature. Successful scientists could expand the genetic code, create new low–cost drugs, or design engineered bacteria that could reverse environmental degradation.

Of course, with great potential comes the possibility of great harm. The dangers of synthetic biology could come in many forms, initiated by everything from a lapse in judgment to miscalculations in constructing a lab. More important, threats could come in innovative and unexpected forms—manufactured biological circuits with engineered DNA parts, new organisms that can survive in different environments, and biological systems with distinctive biochemical structures. Whether intentional or accidental, the release of any of these types of materials is a crapshoot.

“There are a lot of regulations of the products and uses of synthetic biology, but they’re not called synthetic biology per se,” says Valerie Bonham, executive director of the Presidential Commission for the Study of Bioethical Issues, which has examined DIY bioscience and suggested ways to address concerns. “[Synthetic biology] has a lot of promise and offers a lot of benefits. Unlike in 1975 when genetic engineering first came into the public sphere, [government officials] didn’t call for a moratorium. They instead said this field is at a place that bears continued, ongoing review. . . . They didn’t see the field at this juncture, based on what it can actually do today, as being necessarily, dramatically lacking in regulatory tools.”

Enter the amateur biologist. Hobbyists without extensive scientific training can achieve advances in synthetic biology. In fact, it’s an even more attractive option for practitioners who do not necessarily have doctorate degrees in biotechnology, but come from a variety of non–science backgrounds, including engineering and computer technology. Thanks in large part to the shrinking cost of laboratory equipment and biological materials in the last five years, amateur scientists can enter the field with minimal financial commitment.

“This is a really exciting new model of innovation to me,” says Andrew Maynard, director of the University of Michigan Risk Science Center, an interdisciplinary research center dedicated to supporting science-informed decision making on existing and emerging human health risks. “It’s moving away from big business and big government to a small community doing big things.”

Not every DIY biologist has a skill deficit. The movement has drawn accomplished professionals who may be looking for a place to try out a new theory or to break free from the constraints of government or university labs. They bring their knowledge of security and safety to their home–based scientific endeavors. Meanwhile, inexperienced scientists who haven’t spent years in government or university labs are being trained in the latest biosafety and biosecurity protocols. That can be tricky when considering how to best serve a movement where the only governing law inside a garage lab is the conscience and knowledge of the amateur scientist.

While the media has labeled this new breed of scientists as “biohackers” and “biopunks,” the amateur science community has not embraced these descriptions. Both terms have negative connotations, especially “hackers,” which has gone from denoting a clever outsider to an anarchist and thief in the last 20 years.

“One of the challenges that we have run into on the security side is the use of the term hacker,” says Kavita Berger, associate program director of the American Association for the Advancement of Science’s Center for Science, Technology and Security Policy. “These aren’t hackers in the traditional sense of the word, but it still makes the government and the public wonder what they’re all about and whether they can be trusted.”

No one knows how many DIY labs exist in the United States, and government officials say there is no way they can ever count them given the circumstances of home–based facilities. There are, however, a handful of community labs, most notably Genspace in Brooklyn, New York, and Biocurious in Sunnyvale, California, that provide common lab space for experimentation and offer programs to educate DIY amateurs. These labs are run much the same way as a local gym. They offer memberships for a fee, and members can come and go as they like. While the labs have no ownership of their members’ work, most of them have established codes of conduct and are tailored to provide much–needed scientific training. For example, in February Biocurious offered a course in Biotech 101, which taught participants what they needed to know to complete a biotech project.

“A lot of this is kitchen chemistry,” says Kristina Hathaway, cofounder and chief operating officer of Biocurious. “It’s no more dangerous than what we have under our kitchen sinks, and the community lab is serving as a mentor and watchdog for these people.”

Credible Concerns?
Still, there is risk associated with DIY bio. For critics of the government’s laissez–faire approach to regulating the movement, the concern is that for all its much–discussed potential, there are no guarantees that the promise of DIY bio will outweigh the economic and environmental costs of an accidental or intentional release of hazardous materials.

The accessibility of information about synthetic biology—and the effortless acquisition of lab equipment—has left many worried and looking for greater federal presence in regulating purchases of equipment and biological materials, many of which are already covered by federal laws that apply to government–funded labs, and in monitoring the creation of regional community labs.

The United States (and most state and local governments) has a complex web of measures designed to protect human health and safety in labs, as well as laws to safeguard the environment from toxic waste and other dangerous chemical discharges. This myriad of federal, state, and local laws and regulations provides a substantial safety net for synthetic biology efforts, although these measures are admittedly targeted at traditional labs and research institutes.

“There are a lot of existing regulatory schemes, . . . and on the whole, we have a deep and broad regulatory system for drugs, devices, fuel to energy, chemicals for agriculture,” says Bonham of the Presidential Commission for the Study of Bioethical Issues. “We do have a system in place that deals with many of the anticipated products that come out of labs.”

In its December 2010 report, the commission noted there was uncertainty about the risks of synthetic biology, and that “prudent” government oversight was needed. It urged transparency, coordination, risk assessment, and public engagement. In looking at the work of the DIY community, however, the panel concluded that costs are too high to develop a new organism in a home–based lab, and that the best way to proceed is to maintain a dialogue between amateur scientists and government agencies.

Critics say the lack of specificity in the network of laws in regards to the DIY bio arena is worrying. Government officials and observers say that while there are rules governing the production of certain biological products and definitive safety standards for government-funded and university labs, there is nothing in the law at any level that draws a distinction around the work of amateur biologists.

“There is no real regulatory authority when you actually look at this,” says Todd Kuiken, senior program associate for the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars. “Most of the work these folks are doing isn’t sophisticated enough to warrant laws or regulation. In addition, we’re still trying to figure out whether the community labs fall under the same regulations as government labs or university labs. There are no clear answers to that, except for the few community labs operating under a university. In theory, under current laws these labs could throw their materials out or down the drain without violating anything.”

Experts say that if the worst happens, the DIY bio threat would likely come as a result of one of three releases: an accidental exposure, a deliberate exposure by a researcher or a third party, or the dissemination of knowledge acquired in the lab to a magazine or journal, or by word of mouth.

“Any of these poses a significant threat because, frankly, they don’t know what they’re doing and they don’t have the technological know–how to do it right,” says Gostin of Georgetown’s Center for Law and the Public’s Health. “Even if they did, then it’s potentially even worse because they’ll have the ability to consciously do harm.”

Berger, however, argues that anxieties about DIY biology are mostly overblown, especially at this early stage in the life of DIY science. “The more complex the project, the harder it is to do, and the harder it is to do without a whole bunch of specialized equipment,” says Berger. “There is only so much science you can do in a house right now. It’s not harmful; most of what we’ve seen people do in their own homes is pretty benign.”

Engagement Over Regulation
Despite concerns about potential risks, the biotechnology community has urged the government to follow the path of engagement in dealing with community bio labs and amateurs operating out of their garages or basements. The notion is that these entrepreneurial amateurs are keeping science and science education alive for the future—a worthy goal that shouldn’t be suppressed by aggressive regulation.

The National Science Advisory Board for Biosecurity (NSABB), which falls under the National Institutes of Health’s Office of Biotechnology Activities, released a report in June 2011 that acknowledges the potential dangers associated with DIY biology, especially if materials or equipment fall into the wrong hands. Yet the board’s recommendations centered on how to best engage the DIY community and educate it about the hazards that dual–use materials might pose to the nation’s biosecurity. Dual–use materials are those that could be used for both constructive and nefarious purposes.

“As technologies are developed and commercialized, they typically become more affordable over time and are packaged in ways that facilitate their use,” the NSABB said in its report Strategies to Educate Amateur Biologists and Scientists in Non–Life Science Disciplines About Dual Use Research in the Life Sciences. “Deciphering genomes was once a [multimillion-dollar] undertaking accomplishable only by major collaborations, including those between [f]ederal agencies. Now, genomes are not only deciphered readily and cheaply, they are synthesized by machines obtained over the Internet for only a few thousand dollars.”

“The capacity to reproduce and manipulate not only individual genes, but full genomes, is a development that raises a host of biosafety and biosecurity concerns as individuals undertake these kinds of experiments without the benefit of an institutional infrastructure for training and oversight,” the NSABB said.

With amateur biology still in the formative stage, the NSABB’s recommendations emphasized outreach, education, and a culture of responsibility over regulation, suggesting the government would be better off engaged promoting “positive motives for participation in amateur biology and [stigmatizing] negative ones.” The report encouraged federal agencies to participate in programs with the DIY community and, working in partnership with organizations such as DIYbio.org, a national clearinghouse of DIY bio information, to organize meetings aimed at educating amateur scientists about biosafety.

“The preexisting debate with institutional science is a guide here, and it’s a few steps ahead of this one over DIY biology,” says Brian Gorman, a lawyer and an assistant professor in the Department of Sociology, Anthropology and Criminal Justice at Towson University in Maryland. “The science establishment is arguing first for a culture of responsibility in lieu of regulation and laws. The culture of responsibility should really come hand in hand with regulation of some sort in this case.”

But Gorman isn’t certain lawmakers and government officials will walk down the path of regulation without the public’s prompting. “To get there, you need to have the general populace interested in these activities,” he says. “They need to be worried to push it forward and overcome the resistance. I think we really do need something, even if we’re just drawing a bright line for the gold-rush science that could come out of this.”

The NSABB’s recommendations did not address Gorman’s concerns about the potential mad rush to cash in on synthetic biology and the possible need to slow the process through regulation. Obviously, adopting any type of regulation would be viewed by many as an impediment to the process, both inside the lab and in the search for venture capital for a new bio business. But Gorman and others feel that some constraints should be placed in the law to do just that.

The NSABB did push for federal agencies to take advantage of public events and conferences for face–to–face interaction with DIY scientists to convince them of the need for vigilance.

“Message points should focus on the relative ease with which amateur biologists can now, and even more so in the future, develop findings and technologies that could be abused by those who would do harm,” the report noted in one of its observations. “Being mindful and responding responsibly to this potential outcome is not only the responsibility of the institutionally based scientific community, but indeed all those who practice science, at whatever level and for whatever well–intended purpose.”

The DIY community has embraced this approach wholeheartedly. “We do a lot of education and a lot of curiosity–satisfying at our lab,” says Hathaway of Biocurious. “If the government approached this with a heavy hand, we’d scare them off. I don’t think people are ill–intended. I just think it’s easier to make a mistake when you haven’t been trained.”

A Cautionary Tale
Casting a long shadow over the DIY bio movement is the case of Steven J. Kurtz, an art professor at the State University of New York at Buffalo. The case has been held up as a warning about overly aggressive law enforcement in cases involving home laboratories. While not a scientist—professional or amateur—Kurtz uses DNA and other biological materials in his artwork.

In May 2004, Kurtz and his wife, Hope, had been preparing commissioned works when Hope Kurtz died at their home. Her husband called 911. Her death was later determined to be of natural causes. In attending to Hope Kurtz, emergency personnel observed Petri dishes containing bacteria cultures and food–testing equipment that was considered suspicious. They contacted the Federal Bureau of Investigation (FBI).

Authorities later told Kurtz he was being investigated for bioterrorism, and, eventually, Kurtz and Robert E. Ferrell, former chair of the University of Pittsburgh’s Department of Human Genetics, were indicted on mail and wire fraud for their alleged efforts to obtain biological organisms from a lab that was not allowed to sell to individuals.

In April 2008, a federal judge dismissed the mail and wire fraud charges against Kurtz, noting that there was insufficient proof to go forward. Ferrell was fined $500 after pleading guilty to a count of mailing an injurious article, a misdemeanor.

Scientists had feared the case would be precedent–setting, but instead it has turned out to be a cautionary lesson about the dangers of under–educated law enforcement personnel who cannot tell the difference between a bioterrorist lab and an artist’s studio using common bacteria.

The FBI says it has done much to make sure the Kurtz incident stays as the exception rather than the rule. Many safeguards and precautions have been put into place since the announcement, most important, the education of local law enforcement about DIY scientists and labs.

“If something Kurtz–like did happen and a neighbor was driving by, saw an open garage door and what looked like a laboratory setup and reported it, there is still going to be due diligence from local law enforcement,” says Edward You, a supervisory special agent with the Biological Countermeasures Unit of the FBI’s Weapons of Mass Destruction (WMD) Directorate. “The response is going to be commensurate because there’s education going on to make sure the appropriate response is made.”

A Model Effort
Much of the credit for the successful education and outreach efforts on DIY bio in recent years goes to the FBI. The bureau has developed a respected DIY bio program that touches most of the community labs and many individual bio hobbyists. The program’s emphasis on sharing information and making connections between amateur scientists and local law enforcement has eased concerns on both sides, and provided an avenue for ongoing conversations.

“The FBI certainly can’t go out and just monitor everybody,” says William So, a policy and program specialist with the Biological Countermeasures Unit. “We abide by the Constitution. There are limits and restrictions that we have to abide by. In recent years, the atmosphere has made it more amenable to conduct outreach in terms of partnering and building relationships.”

While hand-holding research labs does not regularly fall under the FBI’s purview, the agency is a commanding presence in the DIY community. That’s why the FBI’s local WMD coordinators have become the focal point of the agency’s outreach operations with DIY scientists. They not only understand the differences between a legitimate lab and an illegal one, they have the ties to local law enforcement to ensure that firefighters, environmental health specialists, and police officers are informed about DIY labs in the area and can respond appropriately.

Additionally, Joint Terrorism Task Forces, made up of specialists from dozens of U.S. law enforcement and intelligence agencies, are housed in 103 cities nationwide, including in each of the FBI’s 56 field offices, to stay connected with community labs and to continue the outreach effort. The FBI also works with the U.S. Department of State on biosecurity and the Department of Health and Human Services on biosafety in monitoring the DIY bio movement.

It’s hard to imagine a community welcoming the attention of the FBI, but many supporters of the DIY science movement do just that. “I didn’t think this FBI program was going to work,” says Kuiken of the Woodrow Wilson Center. “With a name like Weapons of Mass Destruction Directorate, it had this image of danger and something to worry about. The FBI has been pretty successful in getting a bunch of actors together, who came out of a computer-hacking mentality, to openly talk. That’s pretty amazing.

“What this program does is it also allows the FBI not to overreact to situations that might occur. If someone on the street calls first responders, you don’t want them to come in with guns blazing into a situation that’s completely safe and harmless,” adds Kuiken.

This FBI strategy was launched several years after the Kurtz incident. Well aware that accidents will happen, even in university and government labs that are heavily regulated by the federal government, the FBI’s goal is to “minimize the chances of that happening by bringing the right people together to educate them and have them understand what is going on in their communities,” according to So.

In reality, the mission of the outreach program is to let community labs and at-home scientists know that they are potentially vulnerable to exploitation and abuse. “The impetus for our outreach to amateurs and professionals is not because they are the risk,” says So. “The impetus is because they are at risk. We want to make sure they can carry out their research.”

Managing Scientific Discovery
A policy of engagement may have worked well for the early stages of DIY biology, but some observers believe it’s time for the federal government to take a more deliberate regulatory approach to oversight of DIY hobbyists.

A number of regulatory approaches have been put forward: requiring biosafety training for all practitioners through programs designed by the Centers for Disease Control and Prevention, registering community labs with government agencies, requiring some type of personal liability insurance, excluding felons from DIY activities, and instituting screenings for loyalty and integrity.

One of the novel ideas from those concerned about the progress of the DIY science movement is to use the U.S. Patent and Trademark Office as an entry point and backstop for monitoring DIY science activities. In such a case, any patent applicant would need to prove he or she had gone through biosafety training, has insurance, or hadn’t spent time in prison.

“We’re creating these safe havens where they can do this research, but I’m not sure I want them working on the next pandemic vaccine in their basement,” says Gorman. “Someone has to know what they’re doing.”

One of the growing areas of concern is how to best handle the dissemination of scientific knowledge, whether it is a product of government-funded labs or of one’s kitchen or basement. A prominent recent case has tested the principles of freedom of speech and the independence of scientists, especially in light of biosecurity, when dealing with highly dangerous substances.

The controversy stems from two studies that detail how to produce strains of the H5N1 avian influenza virus. The papers, which were going to be published in Science and Nature magazines, revealed information on how to develop the virus so it is more easily transmissible to ferrets. The studies were the work of separate teams of scientists led by Ron Fouchier, a flu virologist at Erasmus Medical Center in Rotterdam, the Netherlands, and Yoshihiro Kawaoka of the University of Wisconsin–Madison. In March the NSABB reviewed the revised manuscripts and urged the federal government to allow full publication. The government had asked the two publications to redact certain sections of the papers to avoid revealing critical details that could be used to create similar mutant viruses. The magazines have agreed to do so, as long as the government finds a way to share the redacted information with scientists in the field. The debate continues, however, on whether to lock this model into law.

“What we are experiencing is a watershed moment,” says Gostin. “There has been a resistance to delaying the release or restricting high–consequence science to the crowd that most needs it. We need to draw a circle around this type of information, no matter where it comes from.”

Gostin says the federal government needs to establish a policy to handle these types of disclosures for all labs, especially DIY labs where amateur scientists may not be as sensitive to concerns about information release. “One could very easily envisage somebody doing a video of their findings and just posting it on YouTube. Even if this person is well–intentioned, simply the fact [he or she] could make this knowledge public demands some kind of action,” says Gostin.

Setting limits through regulation may lend a sense of security, but it also could threaten U.S. economic security, DIY science entrepreneurs say. They see a tremendous downside to the United States moving too swiftly or comprehensively to restrict DIY activities and throw up roadblocks to scientific investigation. It’s a mistake other countries won’t make in the world of competitive science.

“If the United States decides to restrict access to these technologies, there are countries whose explicit policy is to beat the U.S. in biotech,” says Carlson of the biotech company Biodesic. “They would seize whatever was banned in the United States and try to gain an advantage from that. The only thing we do if we restrict access to these technologies is slow ourselves down and incentivize other countries to go faster. We can’t afford to unilaterally disarm.”

Balancing Risks and Innovation
Whether the United States disarms or not, the challenge will be how to encourage amateur scientists to take their fledgling steps toward discovery without scaring them into the dark corners of anonymity. No one benefits from science nurtured in the secretive recesses of a basement or a closet rather than in community labs where experiences and ideas can be shared.

“It is important that within appropriate boundaries, boundaries appropriately tied to realistic, recognized risks, we allow science to proceed,” says Bonham.

Going forward, it’s critical to have a public dialogue about the potential dangers of DIY science without bringing greater scrutiny from bad actors to the surprising quality and innovation of amateur scientists. That’s why many in the field believe that the best way to address concerns is to educate hobbyists on biosafety and biosecurity protocols, and then count on them to spread the word to their peers.

“The FBI can only engage with so many people, and so we need all of the DIY community to participate in the education and outreach process,” says Berger of the American Association for the Advancement of Science, the world’s largest general scientific society. “They can engage with their peers and send the message that if you want to do it, do it safely.”

That’s why the Woodrow Wilson Center’s approach is winning converts. It stresses information and education in two key ways. Working with DIYbio.org, it is helping to develop a code of ethics for amateur scientists and developing laboratory safety norms. In addition, the center has partnered with the American Biological Safety Association, an international membership organization of biosafety professionals in more than 20 countries, to create a Web site where DIY hobbyists can ask experts questions about safety.

“The first step is to make sure these community labs know what the standards and best practices are,” says Maynard of the University of Michigan Risk Science Center. “There is nothing worse than these community labs not knowing what they can and should do to manage safety.”

Government officials have shown a sensitivity to the unique position of science in society and to the importance of getting engagement right today to ensure that robust relationships are built for tomorrow when DIY bio becomes even more sophisticated, and threatening.

“It’s always a delicate balancing act,” says the FBI’s So. “We certainly have our mission in terms of preventing risk or threat to the country, but we understand that research needs to go on. They are creating the next generation of medicines or medical treatments or innovative technologies that could help us all in so many ways.”

Sarah Kellogg is a Washington, D.C.–based freelance writer who last wrote about fiscal strategies for attorneys.