EXCLUSIVE – DIY Bio: Separating Fact from Fiction

Do-It-Yourself biotechnology, or DIY bio, evokes strong feelings, both for and against such activities. On one side is the argument that the proliferation has made sophisticated technology available to those lacking the fundamental understanding of the science and few controls on individual activities, making the chance of an accident or misuse of the technology more likely. On the other side is the history of technology, which begins with theories and experimentation and results in discovery, fundamental understandings and technological advancement.

In the  movie “Quarantined,” someone working on a designer rabies virus in a DIY bio laboratory in the basement of a hotel inadvertently releases the deadly virus with devastating consequences. The result is a “mad scientist” conducting dangerous biological experiments causing public panic. The storyline makes for high drama, but is such a scenario plausible or even possible?

Fast forward to February 2016 when then Director of National Intelligence (DNI), James Clapper, who said in the Worldwide Threat Assessment that gene editing is in the category of “global threats” and  “weapons of mass destruction.” He cited concerns about the “risk of the creation of potentially harmful biological agents or products, going on to highlight the “broad distribution, low cost and accelerated pace of development of this dual-use technology, [and that] its deliberate or unintentional misuse might lead to far-reaching economic and national security implications.” While not directly calling-out DIY bio or synthetic biology, one could easily infer that gene editing technology could fall into this category of concern.

Yet, these scenarios highlight only half the story. The development of the smallpox vaccine provides the counterpoint to the first two examples. Dr. Edward Jenner’s observation that milkmaids having been infected with cowpox did not become sick with smallpox became the basis for exposing the 9 year-old son of his gardener, James Phipps, to material from a cowpox sore. Months later, when Phipps did not become ill following several challenges with the smallpox virus, Jenner’s DIY bio experiment led to the first successful “vaccination.” Such early discoveries were far less about the venues where research was conducted and far more about gaining a fundamental understanding of the science and technology. DIY bio falls into this same category of activity.

So what is DIY Bio?

First, a little bit about what DIY is not. It is not synthetic biology, although it is closely related and many involved in the DIY bio movement are most interested in conducting experiments with these technologies. Some might even goes as far as to say that syn-bio served as a catalyst for DIY bio. Common DIY bio experiments such as changing the characteristics of an animal—say making a frog translucent—or creating a new color of flower both rely on syn-bio technology.

It is also not biohacking, although the terms have at times been used synonymously. In fact, no “official” taxonomy of terms exists in this field, resulting in a degree of confusion about how to address the issues and what, if any, limits should apply. Some even consider biohacking to be an umbrella term, encompassing DIY bio, grinding (think developing an augmented or enhanced capability such as being able to hear a cell phone without headphones through radio signals into magnetic frequencies), body modification and even slang for synthetic biology.

The DIY bio traces its roots to Boston in 2008 when a group of individuals came together to expand their knowledge of biology. DIY bio and the related international genetically engineered machine (iGEM) competition, with its registry of over 20,000 standard biological parts, provide access to biology that has until now not been possible.

As one author pointed out, DIY bio has been influenced by four related factors that predate that 2008 meeting: the general growth of DIY across various fields that became popular in the 1990s, the emergence of a citizen science movement, the translation of  “free software and hacking practices from computers and software” into the field of biology and a “maker movement” that has gone from woodworking to fields such as 3-dimensional printing and robotics. The expansion of DIY into biotechnology becomes the logical extension of these four factors.

Since 2008, DIY bio has grown into an international phenomenon, whose members have diverse interests. What began as individuals conducting experiments in garages and basements has expanded into community labs, or Do-It-With-Others (DIWO) labs. Much of the DIY bio is now conducted in regional biology laboratories, where participants normally pay a fee to gain access to laboratory facilities and equipment.

Some turn to DIY bio out of curiosity, others to gain better understanding of biology, and still others in the hopes of discovering new uses for biology and perhaps even deriving economic benefits from their discoveries. Participants have a wide range of backgrounds from amateurs with little or no biology background to experts that provide assistance in the labs as well as utilize the facilities for their own purposes.

In looking at the population of DIY enthusiasts, one study found that 28 percent of the respondents worked in corporate, academic or industry biology labs, 92 percent worked at least some time in communal labs in garages and basements, less than 6 percent worked on projects that would require safety conditions for preventing disease and that the population was younger and more educated than the general population.

The potential benefits of DIY bio are numerous and would closely follow other areas of science and technology that have seen great expansion of understanding and capacity based on citizen movements. Examples include astronomy, amateur (or ham) radio and most recently personal computing. In each, the greater understanding of the science and technology has spurred the quest for more advanced capabilities which in turn drives further discovery and innovation. Entire industries have been launched by DIYers. The Wright Brothers and Henry Ford can be considered early DIYers developing aircraft and automobiles, respectively, as the result of their experimentation and discovery.

DIY labs provide open access to resources, a venue to share common interests with fellow participants and a cost effective way to engage in biological discovery. No restrictions are in place that precludes participation, in contrast to industry and academic labs that normally require certain certifications and educational backgrounds. Lectures, training and support are available at many DIY community labs. In exchange, DIY biologists gain access to information that allows them to engage in biological more safely, use proper equipment, provide opportunities for training and have a code of ethics to guide their efforts.

DIY biologists have the freedom to engage in projects and discovery on topics of personal interest. They would not be driven by the bottom line or by a grants process, but rather but their interests and the quest for discovery. They bring a diverse range of experiences that allow a potential cross-pollination between biology and other fields, thereby stimulating innovation. A structural engineer could use biobricks to build self-assembling micro structures, an electrical engineer could use synthetic biology to design electrical circuits, or a chemical engineer could use biological material to develop synthetic fuels that are environmental friendly and cost effective. The list of possibilities is limitless.

One such technology that evolved from DIY bio is OpenTron, a device that combines robotics and software into a tool that allows for precise handling of liquids. The result has been the development of a multimillion dollar company.

In a world that is increasingly relying on and being driven by science and technology, DIY bio could serve as a catalyst for attracting more people—especially young people—to science, technology, engineering and mathematics or STEM, serving as a pipeline for developing more STEM literate people into an economy that will surely have a demand for such skills.

Managing the risks of DIY Bio

Risk is inherent in all discoveries. By its very nature, discovery implies doing things that have never been done before, taking chances, many times failing and even at times accidents and missteps. The point is not to undertake a Sisyphean effort to eliminate all risk, but rather to manage risk prudently.

The history of technology — that is, any technology that has benefited humankind also comes with risks that it might be misused — means that prudent measures must be in place to reduce such risks. However, caution must be exercised in attempting to regulate and control biotechnology, including DIY bio. Too much regulation and control, and the endeavor could be stifled. Too little regulation and there is the potential for accidents and misuse.

The combination of democratization and deskilling of technology has provided greater access to biotechnology coupled with the requirement for less tacit understand of and bench skills for performing complex biological manipulations.

While the history of DIY bio to date has been one of relatively simple experiments with non-disease-causing biological material, this is not to say that the future will not look very different.

The focus of education and oversight in labs provides a conducive environment for learning about biology in a semi-controlled environment. It also serves to reduce the chance of inadvertent accidents and missteps.

Mechanisms are in place to provide structure for both traditional and DIY biology. International and US laws provide limitations on the nefarious use of biology, such as bio manufacturing for developing narcotics. The Biological Weapons Convention serves as the unequivocal norm against the use of biological pathogens or biologically derived material as weapons. US laws based on the BWC limit potentially dangerous behavior. Guidelines in the form of regulations and oversight serve to elaborate on and define acceptable behavior, more structured for traditional biology and less formal for DIY bio.

In government, commercial and academic labs, codes of ethics and oversight committees serve to instill proper behavior and techniques by scientists and limit the range of experiments that can be conducted. The Biosafety in Microbiological and Biomedical Laboratories (BMBL), the institutional biosafety committees and, most recently, the White House Executive Order on Dual Use Research of Concern (DURC), govern the activity in labs. Encompassed within DURC are the seven categories of experiments that are not permitted, such as enhancing the harmful consequences of a biological agent or toxin or disrupting immunity or the effectiveness of an immunization. The controls become even more stringent for those working with Select Agents, those pathogens that are considered to be the most dangerous with applicability for use as bioweapons.

For DIY bio, the development of a code of ethics reinforces the proper “rules” for engaging in this science. The 2011 DIY bio Code of Ethics from North American Congress contains seven principles: open access, transparency, education, safety, environment, peaceful purposes and tinkering. Of the seven, only tinkering implies a degree of risk. The other principles are limiters designed to establish a degree of control—or at least self-limitations–over DIY bio activities. Tinkering, on the other hand, implies a spirit of pushing limits, testing hypotheses and perhaps even going to the “bleeding edge” of the technology.

In what be considered a nontraditional approach to “governing” DIY bio, the federal government, largely led by the FBI, has taken an effort to support and guide the community with the belief that such support will ultimately provide greater access and awareness of developments in the DIY bio community. Such welcoming support also serves to make community labs more inviting, rather than driving DIY bio enthusiasts into garages and basements.

The FBI manages its outreach through the weapons of mass destruction or WMD coordinators that reside in 56 field offices around the country. These coordinators provide links across the wider DIY bio community, with an emphasis on developing a shared responsibility for researchers. They also serve as a sort of neighborhood watch and reporting chain in the event of suspect behavior. International FBI coordinators also reach out to develop international partnerships. To date, no direct threats have been identified, although some vulnerabilities have been addressed.

In these community laboratories, the risk is reduced through the use of proper equipment and procedures. If someone does violate procedures, peer policing and, if necessary, reporting procedures can be employed to halt risky behavior with the potential for causing harm.

Not all see the benefits of DIY bio as worth the risks. The reaction in the United States stands in stark contrast to the German reaction, where DIY biotechnologists are being threatened with prison and stiff fines. The recent crackdown is based on " long-existing law that forbids genetic engineering experiments outside of laboratories supervised and licensed by the state."

Coming back to the question of why former DNI James Clapper called out gene editing on the list of global threats, it is less about the threat today than the threats looking into the future. As biotechnology continues to be democratized and deskilled–allowing access and capabilities to individuals that either may not understand the nature of the experiments they are conducting or alternatively attempting to employ these technologies towards dangerous and hostile purposes—the threat will undoubtedly grow. When it does, governments may need to consider additional laws and regulations to ensure the proper use of the technology and the community may need to consider placing further limitations and guidelines on DIY bio activities.

Conclusions

The DIY spirit is embedded in humankind’s quest for discovery and knowledge. As DIY bio continues to evolve, two “courses of action” are available.

The first would be to place harsh limitations on such activity, but that would ultimately be counterproductive and likely fail. The second would be to embrace DIY, understand its risks and limitations and work collaboratively with the community to shape activities to ensure the safety of those conducting the experiments and the general population. If and when boundaries are breached, swift and appropriate actions must be taken to remediate the actions and even discipline the offenders.

Throughout, the need to balance knowledge and innovation with safety and managing risks will be essential. Too much regulation and control and biotechnology progress could be stifled; too little there is the potential for accidents and misuse.

Finally, important outreach will be important to ensure law enforcement and society at large understands DIY bio. The image of DIY bio in the movie “Quarantined” must be replaced with a more nuanced understanding of the benefits and risks of the use of biotechnology.

As the DIY bio movement continues to grow, we would do well to remember another DIY movement –the Homebrew Computer Club– which led to the creation of Apple Corporation and launched the dawn of a new era.

Daniel M. Gerstein works at the nonprofit, nonpartisan RAND Corporation. He was the former Under Secretary (Acting) and Deputy Under Secretary in the Science and Technology Directorate of the Department of Homeland Security from 2011-2014.

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Preventing Synthetic Pathogens from Getting Into the Wrong Hands

Anthony L. Kimery, Editor-in-Chief

In March 2007, the Homeland Security Today cover report, Viral Visions, explored emerging concerns over disturbing new developments in synthetic genomics and biological research that provide the potential for new and lethal designer pathogens. Deadly pathogens that can be created virtually from scratch.

In late November, 2007, the Department of Health and Human Services took the first step toward imposing controls on the synthetic genomic industry in the form of guidelines for companies to follow to screen for suspicious orders for customized DNA sequencing placed by companies and individuals.

Because of post-9/11 concerns over bioterrorism, the National Science Advisory Board for Biosecurity (NSABB) was charged with identifying the potential biosecurity issues raised by the ability to synthesize “Select [controlled biological] Agents” and providing advice on whether current government policies and regulations adequately cover the de novo synthesis of these Select Agents. The panel’s report, Addressing Biosecurity Concerns Related to the Synthesis of Select Agents, was formally transmitted to the government in March 2007.

The NSABB determined that the technology “employed in the field of synthetic genomics to create sophisticated live vaccines and to discover new therapeutics for infectious diseases … can be misused to generate dangerous pathogens de novo that are subject to oversight, thus circumventing the extant regulatory framework for controlling the possession and use of such organisms.”

This dichotomy illustrates the dual use nature of synthetic genomics and underscores the need to develop strategies to address the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security,” the report determined.

“In this regard,” the NSABB report concluded, “rapid advances in DNA synthesis technology and the open availability of pathogen genome sequence data have raised concerns in the scientific community and general public regarding the possible use of this technology and information to generate biological agents that could threaten public health, agriculture, plants, animals, the environment, or material. Special concern has been voiced about the use of this technology to generate Select Agents de novo.

Continuing, the report stated that “while traditional recombinant DNA technology has raised similar or related concerns, approaches based on de novo synthesis avoid any need for access to the naturally occurring agents or naturally occurring nucleic acids from these agents, and greatly expand the potential availability of these agents. The National Science Advisory Board for Biosecurity has been charged with identifying the potential biosecurity concerns raised by the ability to synthesize Select Agents and providing advice on whether current United States Government policies and regulations adequately cover the de novo synthesis of Select Agents or whether additional biosecurity measures are necessary.”

The NSABB Working Group on Synthetic Genomics’ assessed the adequacy of the current regulatory framework to safeguard against themisuse of this science and made recommendations to address their concerns. The recommendations were approved by the NSABB on October 25, 2006.

“Toward this end,” on November 27, 2007, the Office of the Assistant Secretary of Preparedness and Response (ASPR) within the Department of Health and Human Services issued the Notice of proposed rulemaking, “Screening Framework Guidance for Synthetic Double-Stranded DNA Providers.” ASPR is the lead agency in a broad interagency process to draft the guidance stemming from the NSABB’s recommendations.

The notice stated “technologies that permit the directed synthesis of polynucleotides, which underlie synthetic biology and more specifically synthetic genomics, could enable individuals not authorized to possess [physical biological] Select Agents to gain access to them through their de novo synthesis. Such synthesis obviates the need for access to the naturally occurring agents or naturally occurring genetic material from these agents, thereby greatly expanding the potential availability of these agents.”

The draft voluntary guidelines for the gene and genome synthesis industry explained that “synthetic biology, the developing interdisciplinary field that focuses on both the design and fabrication of novel biological components and systems as well as the re-design and fabrication of existing biological systems … is not constrained by the requirement of using existing genetic material. Thus, technologies that permit the directed synthesis of polynucleotides have great potential to be used to generate organisms, both currently existing and novel, including pathogens that could threaten public health, agriculture, plants, animals, the environment, or material.”

In order “to reduce the risk that individuals with ill intent may exploit the commercial application of nucleic acid synthesis technology to access genetic material derived from or encoding Select Agents or Toxins, the US government has developed recommendations for a framework for synthetic nucleic acid screening” to identify suspicious intent on the part of purchasers of synthetic genomic products from commercial suppliers, the notice stated.

The proposed rulemaking “is intended to provide guidance to producers of synthetic genomic products regarding the screening of orders so that these orders are filled in compliance with current US regulations and to encourage best practices in addressing potential biosecurity concerns.”

The notice declared that “the US government acknowledges that there are synthetic nucleic acid sequences from non-Select Agents or Toxins that may pose a biosecurity concern,” and therefore “the primary goal in developing guidance for synthetic nucleic acid providers is to minimize the risk that unauthorized individuals or individuals with malicious intent will gain access to toxins and organisms of concern through the use of nucleic acid synthesis technologies.”

The CIA began worrying in earnest about designer pathogens soon after the October 2001 anthrax attacks provided evidence indicating the anthrax had been weaponized. An expert panel was convened to study the problem and to make an assessment of the seriousness of a synthetic viral threat.

Following an outcry from some of the scientists it empaneled to study the issue, the CIA Intelligence Directorate’s Office of Transnational Issues quietly released a short, unclassified synopsis of the academician’s November 2003 report, The Darker Bioweapons Future. The report concluded that the “growing understanding of the complex biochemical pathways that underlie life processes has the potential to enable a class of new, more virulent biological agents engineered to attack distinct biochemical pathways and elicit specific effects.”

Although the two-page abstract provided no details concerning the expertise, equipment and facilities required to develop engineered pathogens, nor a time estimate for how long the development process might take, more than five years later the CIA—and other IC components —continue watching developments very carefully.

Indeed. Synthetic bio- threats are carefully being monitored by American intelligence authorities and bio-weapons experts. And apparently there’s reason for them to be more concerned than they were more than two years ago when the Viral Visions report noted that the ability of individuals to create frightening new viruses in their basements was rapidly growing.

In 2007, the Wall Street Journal tackled the problem in the story, In Attics and Closets, ‘Biohackers’ Discover Their Inner Frankenstein.

Under the subhead, Using Mail-Order DNA and Iguana Heaters, Hobbyists Brew New Life Forms, the report highlighted that “do-it-yourselfers tinker with the building blocks of life in the comfort of their own homes.” The report asked whether these “biohackers [pose] a threat to national security?”

The report quoted “a senior official in the FBI’s Weapons of Mass Destruction Directorate saying the bureau is working with academia and industry to raise awareness about biosecurity, ‘particularly in light of the expansion of affordable molecular biology equipment’ and genetic databases.”

A variety of federal officials who had expressed these same concerns to Homeland Security Today recently reiterated their worries, pointing to the very sorts of home basement virology labs that were described in the Wall Street Journal report.

“The ability to create nasty pathogens like your hybrid rabies virus in your bathroom is becoming easier and easier,” one of the authorities said. The official was referring to the description of a synthetic virus like a highly contagious “designer” rabies virus that not only makes the victim mad, but mad enough to want to run around biting people.

In the world of synthetic hybrid pathogens, zombies are “possible,” a virologist who helps the Intelligence Community keep track of the work being done in the field of synthetic genomics earlier told Homeland Security Today.

“The emergence of this field is driven by recent advances in the underlying technology of commercial DNA synthesis that allow biologists to produce and assemble segments of DNA quickly and cheaply with almost perfect accuracy,” wrote John Dileo in a MITRE publication report.

“While the synthesis of small segments of DNA has been possible for two decades, the use of these early techniques to produce a genome (the complete blueprint, in the form of DNA, for the construction of an organism) would have required years of work and been prohibitively expensive,” Dileo continued. But today “DNA production and assembly techniques have advanced to the point that a medium-sized virus can now be constructed in weeks. In addition, these improvements have led to a rapid increase in the number of companies that offer whole gene synthesis. The resulting competition has lowered prices to within the budgets of most researchers.”

Several years earlier, in the paper, A Practical Perspective on DNA Synthesis and Biological Security, published in Nature Biotechnology, the authors stated that “few developments have leapfrogged over predecessor technology as quickly and extensively as synthetic biology. Based on cutting-edge DNA synthesis technology, synthetic biology has already fueled an expansion of opportunities in biological engineering, with advanced capabilities that surpass those provided by traditional recombinant DNA technology.”

But while “synthetic biology promises vast improvements to our well-being and our understanding of the living world,” the paper’s authors cautioned, they also pointed out that “like any powerful technology, DNA synthesis has the potential to be misused. In the wrong hands, the new capabilities enabled by synthetic biology could give rise to both known and unforeseeable threats to our biological safety and security.”

And “currentgovernment oversight of the DNA synthesis industry falls short of addressing this unfortunate reality,” the authors warned.

The group of academics who authored the paper called “for the immediate and systematic implementation of a tiered DNA synthesis screening process.”

“In order to establish accountability at the user level,” they wrote, “individuals who place orders for DNA synthesis would be required to identify themselves, their home organization, and all relevant biosafety level information.”

It’s just that sort of information the federal government wants the synthetic genomics industry to collect and scrutinize when fulfilling orders for customized DNA sequencing.

Seeing the scores of companies that pop up under the Google search, “customized DNA sequencing,” and it’s easy to understand the concerns.

[Editor’s note: On August 14, 2013, Homeland Security Today Editor-in-Chief Anthony Kimery appeared in "Biopocalypse," an episode of the SyFy Channel TV series, "Joe Rogan Questions Everything," which dealt with bio-terrorism, designer-hybrid pathogenic threats and unregulated DIY-bio genetics labs. Senior Contributing Editor Charles Faddis, a former CIA officer who led the agency’s WMD counterterrorism unit also was featured in the episode]

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