Mitagation Strategy

For my project, Safeguarding DIY Biology, I will propose a mitigation strategy (regulation) that combines the levers of law, markets, and code. This issue, like the many other technology-focused projects discussed in our class, requires a multifaceted approach to anticipate and stem nefarious use-cases.

Proposal: A centralized federal agency to oversee gene synthesis and biotechnology product licensing in the United States.

Key Provisions:

1. A presiding council consisting of members from the Environmental Protection Agency (EPA), US Patent and Trademark Office (USPTO), National Institute of Health (NIH), National Science Foundation, academics in social sciences and scientists, physicians, and representatives from the private sector.
2. Patents for biotechnology products must go through a secondary vetting process that performs a risk assessment of the product in question. Patent applications will be granted a class status: general (no serious risk), limited (potential risk), and reserved (serious risk).
3. Depending on the results of the risk assessment, federal government will either take a minor (general patents) or moderate (limited patents) role in regulating the granting and licensing of patents. In the case of reserved patents, the government will create a commission to research how to inactivate the potential risk. In the case of moderate patents, the government may conditionally grant patents after certain conditions are met by the applicant.

Rationale: Biotechnology is a dual-use technology: it can either be used for the public benefit (drug development) or public harm (bioterrorism, misinformation). Biology research is still heavily networked, it requires supplies and resources (materials) from a variety of actors. Its through these materials that concepts and ideas are realized. These materials are used by DIY Biologists, academic and industrial scientist alike.

Levers in action :

Example: Patent Application for a novel DNA synthesis technology (limited patent)

Background: The building block of biology is DNA. Applications of biotechnology largely require very particular segments of DNA to be generated to create higher order bio-machinery. Because of this, DNA synthesis, the making of strands of DNA is a control gate for many downstream biotechnical outputs.

Law: Creating a federal agency that oversees this process would provide enforcement avenues to hem in potential bad actors. Inventors of a novel DNA synthesis technology would have to follow directives from the government to insure that checks are in place.

Market: Granting patents allows the applicant the exclusive right to market and sell a piece of technology. This is lucrative for the applicant and would provide an incentive for them to patent. If a method like this is implemented, risk assessment checks would be standardized.

Code: Hardware locks on machinery that perform DNA synthesis can used to prevent the development of higher order bio-machinery that is deemed by the presiding council to present risk.

 

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HMW/Divergent Ideas

 

As I’ve worked through some of the recurring themes and issues for my project, I’ve come to see that many of the issues that make DIY Biology difficult to safeguard are similar to the factors that make biology on the whole difficult to safeguard. For this assignment, I decided to tease out some of the factors specific to DIY Biology that can be addressed.

 

HOW MIGHT WE: Make informal biology research responsible

 

Ten Divergent Ideas

1. Create bioengineering licenses mandatory to order material from chemical suppliers
2. Have DIYBio spaces vet/screen potential new projects/ideas
3. Censor biological protocol information on the web
4. Create training modules to educate DIY Biologists about potential risks
5. Limit the kinds of supplies that be ordered by DIYBio labs
6. Create national steward program to fund biosafety officers at all DIYBio labs
7. Have biosafety trainings are DIY Bio convenings
8. Award prizes at DIY Bio competitions for top biosafety programs
9. Create funding available for labs that have active biosafety awareness programs
10. Create a national hotline/tip system to anonymously tip off authorities to bad actors  

 

For my IDEO Design Research Method, I used the card ‘collage.’ The activity involves having participants create a visual representation of the various sides of an issue. I chose this method because it allows for a secondary method of visual mapping, alongside the ecosystem map. While the ecosystem map does a good job of identifying the various stakeholders and how they are affiliated with the issue, in my case safeguarding DIYBiology, it doesn’t hold much space for identifying how and why relationships form between various actors.

To create this collage I spoke, separately, with two members of a DIYBio space in Seattle as well as a biology graduate student at MIT.  I asked them to provide some images or ideas on the various sub-communities and a little bit about how those sub-communities interact with one another. I then compiled the common themes and insights from those conversations into this collage. It was interesting to see where these sub-communities are in conversation with one another. For example, the biomedical and security communities both generate information hazards, and must decide whether or not to disclose them. In practice, this sometimes looks like the body hackers who have to ensure that protocols for implants (like RFID chips) are safe enough to be used in what are often not medical grade settings. Likewise, security communities make decisions on how much to disclose about what is within the realm of possibility using biology. Along another vector, biomedical communities inspire and are inspired by ideas generated from artists working in DIYBiology spaces. Broadly, these relationships are worthwhile to document because they provide potential avenues for intervention. Having an understanding of how information travels between communities allows for easier downstream adoption of practices because it uses pre-existing tracks.

Interview Subjects: A DNA cryptographer, two post-docs (Broad/Whitehead Institute)

Big takeaways:

DIYBiology isn’t the threat: The biggest surprise for me from these interviews has been that I may have overestimated the potential threat of nefarious do it yourself biologists. While the two post-docs I interviewed had heard of the DIYBiologists, neither seemed to think that it would be feasible (from a technical basis) to gather the infrastructure or technical know-how needed to make something that could cause serious harm. One made the point that while papers have been released on controversial topics (i.e. Horsepox), the margin of error of mistakes leading to experimental failure is low and the ad-hoc knowledge needed to develop highly technical molecular biology products is so large that you would need deep experience before being able to cause real harm. They did concede, however, that if the practitioner was already well trained (coming from an institution) and used a DIYBiology lab as a space to do work, that kind of person might be able to do real harm.

Adoption of any code based method will be slow: Code based systems are back-end intensive. The DNA cryptographer I spoke with is working a project to encrypt DNA synthesis for sensitive applications (primarily DNA sequences known to be hazardous). This involves creating a repository database of all hazardous DNA sequences and having all DNA synthesis companies/synthesizers rely on this database to query all orders before making DNA. The process would work much like how photocopiers are all unable to photocopy currency. This process requires first creating such a databases and then convincing the many suppliers of DNA synthesis machines to adopt it. One of the cryptographers biggest concerns is how to gather the support and adoption of their system or any such system. Without the buy-in from the synthesis companies themselves, they are dead in the water. Photocopying currency has a clear and direct call-to-action, which can be understood and made relevant to the lever of the Law. DNA cryptography is very technical and doesn’t have the same kind urgency. Acting on just the lever of code is difficult work.

Biology is hard to do by yourself. More than just the collection of theories and logic it’s grounded in, the physical and organizational infrastructure required to develop projects make the barrier to entry quite steep. This makes it ever the more surprising that in the last ten or so years, a community of “do it yourself” biologists have found a way to actualize projects on scales approaching those of institutionally supported laboratories. Concurrently, the past two decades have seen the rise of synthetic biology, a sub-discipline that integrates the methods, strategies, and tools of engineering with the study of life. The confluence of these two developments has raised moral, ethical, and existential concerns with the democratization of biology.

Synthetic biology is a dual-use technology. Just as easy as it is to see how the application of engineering thinking to come up with ways of repurposing nature’s toolkit to tackle, say, waste management or develop more drought tolerant vegetables, it is also easy to see how biology can be weaponized to recreate pathogenic viruses or develop deadiler versions of the ones that plague us today. Biotechnology is regulated in the United States, broadly, by the UDSA, the FDA, and the EPA. However, on a more granular level, the processes, spaces, and materials involved in the practice of synthetic biology are managed by a wide web of companies, norms, and relationships. My network map attached begins to show how these actors are related. Safeguarding_DIY_Biology MAP

Values:

We seek collaboration: we work better when we work together

We seek inclusivity: our work is better when we draw people together

We seek community: we work better when we consider how we came together

We seek understanding: we work better when we consider why we came together.

We seek knowledge: our work is better when we draw our collective knowledge together

 

Topics:

DIY Highly Virulent Pathogens

Background: As the tools and methods of biology become more readily available, the Do-it-yourself (DIY) biology community has come under scrutiny as a potential breeding ground for nefarious uses of biotechnology.

Invasive Population Management

Background: In 2016 the New Zealand government introduced Predator Free 2050, a project to eliminate all non-native predators (such as rats, possums and stoats) by 2050. Non-native predators have been harmful to native flora and fauna of New Zealand, especially conserved bird species.

 

Convening:

I am helping organize the Global Community Biosummit at the Media Lab this October 26-28. This conference brings together people involved in the DIYBio/biomakerspace movement together with people from independent and community biology labs. Last year, I attended as a participant from a community lab and this year have a more active role as an organizer.

 

The three key features of the programming that I feel strongly committed to are the unconference session, the workshops, and the exhibition space. The unconference sessions are informal discussion sessions that are proposed by the convened. The workshops are practical, skills-based sessions where knowledge is disseminated. The exhibition space is available to show works of hardware and art.

 

My practice as a scientist is deeply connected to the idea of bringing people together to solve problems. As a part of the Sculpting Evolution group, one of our biggest tasks is making science, as a whole, more open and responsive to the communities it affects. For the Biosummit, we are developing an unconference session to talk about the ethics of responsive science in the context of citizen science/DIY spaces. We are also sharing our methods by hosting a Wet Lab workshop on the methods we use to sculpt evolution. Personally, I have been involved in curating and organizing the works that will be displayed in the exhibit space. Interfacing with the community in these ways is how I live within my values.

Vaccinations

Background: Vaccine controversies have occurred since almost 80 years before the terms vaccine and vaccination were introduced, and continue to this day. Despite scientific consensus that recommended vaccines are safe and effective, unsubstantiated scares regarding their safety still occur, resulting in outbreaks and deaths from vaccine-preventable diseases. [Reproduced from Wikipedia/Vaccines.gov]

Code; Vaccines in agriculture are not infrequently added to water supplies. The government at the municipality, state, or federal level could surreptitiously add vaccines to public water supplies.

Norms; Social media and advertising campaigns could across various platforms to stigmatize “anti-vaxxers” and promote vaccinations

Market/Law; The government could provide tax credits or breaks to parents who ensure that their children are up to date on all vaccinations in addition to the tax benefits already provided through the Child Tax Credit. Alternatively, the government might even stipulate that in order to receive the Child Tax Credit, a parent/guardian would have to provide vaccination records.

Invasive Population Management

Background: In 2016 the New Zealand government introduced Predator Free 2050, a project to eliminate all non-native predators (such as rats, possums and stoats) by 2050. Non-native predators have been harmful to native flora and fauna of New Zealand, especially conserved bird species.

Code; One approach to solving invasive populations is to introduce heritable genetic elements that would suppress or eliminate the capacity of non-native predators to reproduce.

Norms/Market; There could be a prize, administrated by the government, for the number of non-native predator carcasses recovered by hunters in a given season. This would support a culture of identifying and hunting non-native predators. This prize could also work as an adjustable tax credit, which would incentivize, monetarily, folks into hunting down non-native predators.

Law; The government could mandate that if animal control found non-native predators were living on private property, they could issue a fee or order community service. Such a law would serve as a scare tactic to get Kiwis to rid their property of non-native predators

DIY Highly Virulent Pathogens

Background: As the tools and methods of biology become more readily available, the Do-it-yourself (DIY) biology community has come under scrutiny as a potential breeding ground for nefarious uses of biotechnology.

Code; The companies that provide gene synthesis could screen all orders for genetic sequences that match or are similar to those for known pathogens.

Norms; DIYBio spaces could have more internal vetting processes for the projects that they run in their spaces

Market; Companies that provide gene synthesis could drastically hike up the price of their services to non-institutionally affiliated consumers. This could drastically limit the kinds of projects that could be done in DIYBiology spaces.

Law; The government could mandate that people who wish to do biology must pre-register their experiments and obtain licenses prior to using gene synthesis services.

While an undergrad, I studied the role of arsenic in water systems with a particular emphasis on Maine. Arsenic has long been acknowledged to have an adverse effect on human health. Found naturally in the Earth’s crust, the World Health Organization (WHO) estimates that over 200 million people worldwide are exposed to elevated levels of arsenic in drinking water. The WHO and US Environmental Protection Agency set a safety standard of 10 ug/L of arsenic, yet in large portions of developing countries like Bangladesh, Vietnam, and Chile, As concentrations regularly exceed the safety standard. In the United States, the US Geological Survey (USGS) considers Maine, along with much of New England to be part of “the Arsenic Belt.” In a 2010 study conducted by the USGS of 174 towns with 20 or more sampled wells in Maine, more than 25 percent of the sampled wells in 44 towns exceeded 10 μg/L. In 19 towns, more than 10 percent of the sampled wells had arsenic concentration over 50 μg/L. While prior studies estimated that nearly 10 percent of domestic wells in Maine contained arsenic, the presence of “hot spot” regions of wells with more than five times the MCL for arsenic in the US had not been well characterized. This is particularly worrisome because nearly 40% of people in Maine rely on wells for their water supply.

The Top-Down Approach

In order to address the arsenic problem in Maine State legislators produced two pieces of legislation to promote well water testing; L.D. 1775 (2007) and L.D. 1162 (2015). Both pieces of legislation gained bipartisan support, yet both were ultimately vetoed by separate governors. L.D. 1775 required well-testing as a component of a contract of sale of real estate property and suffered stiff opposition from the Maine Association of Realtors who had issues with being placed in a quasi-enforcement position to ensure that water testing occurs. L.D. 1162 was a more modest bill to provide state funding for educational outreach to motivate people to get their wells tested and was vetoed by the Governor for ideological reasons.

The Island Approach

The duty of private water sanitation ultimately rests on well owners. Water use from a well can either be treated at the point-of-entry into the household or at the point-of-use. Point-of-entry treatment is typically done with anionic exchange systems. This method works by chelating contaminates to a resin bed and requires very little maintenance.  Unfortunately, these systems also run the very small risk of total failure where all of the captured contamination can be released at once. The most cost-effective method of point-of-use treatment is reverse osmosis, which uses a microscopic membrane to trap contaminants. This method is very effective at removing arsenic, more so than anionic exchange systems. Nevertheless, due to their small size, they can only produce a few gallons of treated water per day. Prices typically range in the $800-$3000 for arsenic specific treatment filters in either range, with point-of-entry systems running in the higher bound and reverse osmosis in the lower bound. Residents of rural areas, where well use is prevalent, typically have lower socioeconomic means than those living in more populous regions. As one might expect, this, in turn, affects the decision to invest in well remediation even in light of the known health risk.

Reflection

Neither option really provided me with a sense that the arsenic dilemma in Maine was adequately managed or handled. The legislative ‘solution’ seemed broken and the technological ‘fix’ was too cost-prohibitive. For me, then a student in Chicago with a clear line of sight to the greatest surface freshwater system in World, I didn’t feel it was my place to tell Mainers water to do. But perhaps at my vantage point, I could work to bring awareness to the issue.

Hi all! My name is Sebastian and I am a first-year graduate student in the Sculpting Evolution group at the Media Lab. My background is in biochemistry and our group works to engineer self-replicating systems using biology. Perhaps the most relevant of these for this class is the gene drive, which can allow an engineered trait or characteristic to spread hereditarily across an entire population — locally or globally.

As you might imagine, ‘self-replicating technology’ seems like a technofix just waiting for its blockbuster dystopian debut. The same innovation that could drastically reduce the incidence of vector-borne diseases like dengue, Zika, chikungunya, Lyme, and malaria may, in the wrong hands, also lead to super-virulent bioweapons…..

So, as we develop these technologies, we try to acknowledge just how thin the tightrope we walk above the pit of unintended consequences truly is. For me, this class seemed like a valuable opportunity to learn how to engage in this work responsibly.