In 2009, President Obama and the National Security Council released the “National Strategy for Countering Biological Threats,” in which the government actually endorsed private, home-based laboratories:
"The beneficial nature of life science research is reflected in the widespread manner in which it occurs. From cutting-edge academic institutes, to industrial research centers, to private laboratories in basements and garages, progress is increasingly driven by innovation and open access to the insights and materials needed to advance individual initiatives" (3.14,3.15).
Crowdfunding
As with any endeavor in this day and age, it is nearly impossible to succeed in a field without the proper funding. As for synthetic biology, scientists and their respective research companies receive most of their funding from the national government as part of many projects posed by the Department of Defense amongst other Departments.
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NSF, or the National Science Foundation, is an agency of the United States that supports fundamental research for non-medical health and engineering innovations. Since 2008, NSF has invested about $138 million in research related to synthetic biology. NSF’s engineering research center for synthetic biology, SynBERC, is set to end in 2016 and due to this deadline, spending has decreased from 2013 to 2014. It is unclear whether NSF will have a dedicated program centered on synthetic biology once the SynBERC program is concluded (3.1, 3.2).
Some of the most impactful applications of synthetic biology could yield massive benefits to human health, the environment and various industries. Scientists could implement synthetic biology to detect and remove environmental contaminants and create safer and cleaner air for us to breathe and water for us to drink. They could also apply synthetic biology to applications that would diagnose, monitor and respond to disease in humans and animals, then develop new, optimized drugs and vaccines. Synthetic biology could be used to create enzymes for bolstering biofuels, as well as increase efficiency in biomanufacturing and chemical technology.
DARPA, or the Defense Advanced Research Projects Agency, is an agency of the United States Department of Defense, and for more than fifty years, it has been responsible for holding to a singular and enduring mission: to make pivotal investments in breakthrough technologies for national security. In previous years, DARPA’s role in funding synthetic biology projects has expanded greatly, eclipsing the role of other prominent U.S. government agencies that fund synthetic biology programs, such as the National Science Foundation (NSF), National Institutes of Health (NIH), and the USDA. In the year of 2014 alone, DARPA funded nearly $100 million for synthetic biology programs.
Recently, synthetic biology has begun to benefit from exposure in the crowdfunding, nonprofessional, community. In 2013, the Glowing Plants: Natural Lighting with No Electricity project raised nearly $500,000 on Kickstarter,the world's largest funding platform for creative projects. This greatly exceeded the project’s $65,000 goal for crowdfunding support. This project raised a variety of ethical and safety concerns, debated publicly and among the academic community. Ultimately, the overwhelming support of this project led to a change in Kickstarter’s policy; the platform began to prohibit projects that offer genetically modified organisms as a personal reward for contributions.
As the field of synthetic biology develops, applications are moving from the realms of ideas and laboratory-confined research towards real-world implementation. A pressing concern, particularly with synthetic microbial systems, is that self-replicating re-engineered cells may produce undesired consequences if they escape or overwhelm their intended environment. The matter at hand is that with synthetic biology comes a risk to the general public as a result of such microbial systems. To address this biosafety issue, multiple mechanisms for constraining microbial replication and horizontal gene transfer have been proposed. Critics of genetic engineering have long worried about the risk of modified organisms escaping into the environment. Two US teams have produced genetically modified (GM) bacteria that depend on a protein building block — an amino acid — that does not occur in nature. The bacteria thrive in the laboratory, growing robustly as long as the unnatural amino acid is included in their diet. But several experiments involving 100 billion or more cells and lasting up to 20 days did not reveal a single microbe capable of surviving in the absence of the artificial supplement.The microbes also do not swap their engineered DNA with natural counterparts because they no longer speak life’s shared biochemical language. Biocontainment could provide added safety in the biological production of drugs or fuels, where microbes can be kept separate from their surroundings (3.8, 3.9).
Scientists Bill Joy and Ray Kurzweil have argued that some knowledge learned from synthetic biology should be kept secret, such as the findings regarding the sequence of the genome of the 1918 flu virus, to protect people and the environment from the risk of physical harm. Following publication of papers that described how to synthesize the mousepox and polio genomes, many concern grew about the risk of physical harm following publication, when the information was accessible. In 2004, the federal government created the National Science Advisory Board for Biosecurity (NSABB). One of the issues on which the NSABB advises government and researchers is the communication of the results of what the Board calls “dual-use research of concern.” According to the National Institutes of Health, Dual Use Research of Concern is life sciences research that can be anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with potential consequences to public and environmental health and safety.
While organisms engineered using synthetic biology will have many new applications, most products engineered using synthetic biology will be regulated in the same way as products engineered using older genetic engineering techniques. Whether an organism is engineered using synthetic biology or older genetic engineering techniques, the U.S. regulatory agencies will be addressing the same types of health and environmental concerns. U.S. regulatory agencies have adequate legal authority to address most, but not all, potential environmental, health and safety concerns posed by these organisms. Such near-term products are likely to represent incremental changes rather than a marked departure from previous genetically engineered organisms. First, USDA’s authority over genetically engineered plants depends on the use of an older engineering technique that is no longer necessary for many applications. The shift to synthetic biology and other newer genetic engineering techniques will leave many engineered plants without any premarket regulatory review. Second, the number and diversity of engineered microbes for commercial use will increase in the near future, challenging EPA’s resources, expertise, and perhaps authority to regulate them.
Many of the synthetic biology applications that George Church and other innovators expect for the future make other people extremely nervous. People fear the possibility of having microscopic organisms “take over the world” What if a mutant virus were to escape from the lab? What if bioterrorists were to get their hands on equipment to synthesize a disease like smallpox? How do synthetic biologists justify such risks? What do they say to those who accuse them of trying to “play God”?
Though the action of “playing God” sounds to have religious connotation, but what most people mean by this saying is that synthetic biologists are changing things in the realm of biology that they are not qualified to change. This means that in their opinion, no one has enough knowledge about life to change such important components of it without posing a huge risk.
There is a vast subdivision of issues surrounding the field of synthetic biology that has not yet been deeply explored: the issues of property rights. There are two main issues that deserve immediate attention within this category. First, synthetic biology has exemplified a difficulty that the government has faced frequently in recent years: the assimilation of a new technology into the conceptual limits posed by existing intellectual property rights. There is reason to fear that tendencies in the way that US law has handled software on the one hand and biotechnology on the other could come together in a “perfect storm” that would impede the potential of the technology. Second, synthetic biology clearly raises an issue that is the tension between different methods of creating “openness.” On the one hand, one standard mechanism for creating openness has involved putting material in the public domain, such as in a database on the internet. Conversely, synthetic biologists may want to use intellectual property rights to create a “commons,” just as developers of free and open source software use software copyrights to impose requirements of openness on future programmers. But synthetic biology, unlike software, is not necessarily protected by copyright. The question to the science community is: “should we rethink the boundary lines between intellectual property and the public domain as a result?” (3.13)
Biohacking, Citizen Biology, DIY Bio. No matter the name, Biohacking is a fairly new practice that is being introduced to “closet biologists,” and usually takes place in small, non-university affiliated labs where a diverse range of people come together to explore biology hands-on. This could mean figuring out how an organism’s genetic code affects its growth, or how to manipulate genes from another source to make a plant glow in the dark. Usually, Biohacking is aimed at producing a tangible result. It tends to be cheap experimentation, usually without the benefit of a high-tech university’s laboratory equipment, and it often involves DNA and genes.
Ron Shigeta, who runs Berkeley Biolabs, a biohacking site in California, says biohacking is “a freedom to explore biology, kind of like you would explore good fiction. The whole idea of biohacking is that people feel entitled, they feel the ability to just follow their curiosity — where it should go — and really get to the bottom of something they want to understand.”
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National Science Foundation
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Defense Advanced Research Projects Agency
Through initiatives such as its Living Foundries program, DARPA seeks to facilitate the creation of a manufacturing platform for living organisms. At the end of September 2015, DARPA awarded the Broad Institute Foundry, an MIT synthetic biology lab, a $32 million contract for designing and manufacturing DNA. But because DARPA is such a great source of funding for synthetic biology projects, it's also important to know that nearly two-thirds of all synthetic biology funding from the federal government is associated with national defense. Given the ramp up in investor attention around synthetic biology, 2016 just might be the year that the once obscure field finally becomes well known, especially as the massive flow of DARPA funding starts to result in viable innovations. Given DARPA’s long track record of success in backing world-changing innovations, it’s only a question of when, not if, the field of synthetic biology takes off from here (3.3).
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Watch "Understanding DARPA's Mission"
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In 2014, another Kickstarter project sought to raise over $100,000 for “Nuclear Waste Clean Up With Synthetic Biology.” Other synthetic biology projects have raised more than $90,000 in support from various crowdfunding websites, including Kickstarter, Indiegogo, Rockethub, and Experiment, a crowdfunding site for supporting scientific research. For synthetic biologists, crowdfunding platforms such as these could become an alternative to the tedious, taxing process of filing for federal grant and waiting months to receive money. With crowdfunding platforms synthetic biologists can think up unique projects for very targeted research interests, without the pressure of having to commit to research for a certain agency or university (3.4).
Did you know...
As of early 2016, (through crowdfunding) the Glowing Plants Project has glowing plants, glowing roses and glowing plant seeds available for online retail?
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Social & Ethical Issues
Despite these potential benefits, however, synthetic biology’s critics argue that the rising field will create a world of unnatural, harmful organisms. There is an evident worry that in the case that synthetic life is released into the environment, the ecosystem could face adverse consequences. Synthetic biology technologies, critics argue, could be used for bioterrorism that would do enormous amount of damage, because synthetic biology allows for the construction of microorganisms that would have debilitating and lethal effects on humans..
Critics have also argued that the benefits of synthetic biology are not significant enough to justify the associated risks; however the success of synthetic artemisinin as an anti-malarial drug is unlikely to convince hardcore critics of synthetic biology’s strides in pharmaceuticals and improvement of the human condition. For thousand of years, science and religion have clashed, and the notion of “playing God” seems to be the basis for objection each time. Nearly every biotechnological accomplishment—anesthesia, birth control, stem cell research, genetic engineering and now synthetic biology—has been met with objections and charges that scientists have violated the natural order of life.
To be sure, there are numerous risks to synthetic biology, but there are also potential benefits that could positively impact the future. As time passes, the cost of DNA sequencing and synthesis is dropping, and more scientists are beginning experimenting with synthetic biology, whether they hold PhD degrees or are high school competitors in the next year’s iGEM competition, scientists will be able to better manage the risks while helping to better our society (3.5).
Since DARPA has shown such great leadership in innovation, from self-driving cars to the development of the Internet, it is definitely worth keeping a close eye on what DARPA is doing in the field of synthetic biology.
Less than 5% of microbes cause disease in humans? (3.16)
Did You Know...
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Censorship
Critics of the censorship approach call it unrealistic and impractical, arguing that it is simply impossible to keep knowledge secret. Some argue that that making such knowledge widely available will enable the development of antidotes and other strategies for managing dangerous substances. Others argue that, as a matter of principle, secrecy is unethical. With regards to the field of synthetic biology, it is currently probably impractical to make every discovery known to the public, due to the speculation, and scrutiny that may be received from those who are uneducated about the relatively new field. But the question is, should the pioneers of synthetic biology do more to educate the public, or would it be more beneficial to censor some discoveries? If there were to be a discovery, say a synthetic polio virus was created, does the public have the right to know in order to stay “safe”? (3.6, 3.7)
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Biosafety & Biocontainment
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"Playing God"
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While synthetic biologists admit that this may be true, they believe that people should also consider that A) nothing is ever done without risk, and B) doing nothing also entails risk. George Church argues that "there's a dark side to every technology," he argues. For example, motor vehicles kill 33,000 people a year in the United States, but that doesn't discourage people from driving or riding in cars. "New technologies always have a higher ratio of scary stories associated with them because they're still unknown." Making a new technology safe and effective doesn't mean making it perfectly safe and perfectly effective, he adds. "It means making it safer and more effective than whatever else is out there."
No one can predict all the challenges we'll face in the future, as individuals or as a society, Church says. But there's one thing he's sure of, and has been since he was a boy: "The best way to predict the future is to change it." (3.10)
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Rules and Regulations
Property Rights
Biohacking & Bioterrorism
Despite its creative and imaginative definition, the term “Biohacking” is often perceived in a negative fashion, as though it is hijacking the natural processes of like. For example, when someone hacks your computer, you want to send him or her to jail. But that’s not exactly what biohacking is. Drew Endy, a bioengineering professor at Stanford, who considers himself a biohacker, says “I come from a tradition where hacking is a positive term, and it means learning about stuff by building, and trying to make things and seeing what happens.”
But there also yet another side to biohacking; there are two perspectives on the topic. One is that biohacking is something that is done to biology, outside of the human body; this includes manipulating a cell, or changing a bacteria’s structure to make it glow in the dark. A different insight on biohacking is that it is a way for humans to “hack” their own biology, and harness control of bodily systems that humans have never been able to access.
As with any unknown technology, the federal government is keeping its eye on garage biohacking and home bacteria manipulation. Law enforcement has even taken some biohackers into custody. But scientists say this approach is Although the idea of a terrorist manufacturing bioweapons in his living room might make some people nervous, the government actually supports the idea of innovating cheaply through readily available products.
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The three principal federal agencies responsible for regulating products developed with synthetic biology’s genetic engineering techniques are the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). APHIS typically regulates field trials of genetically engineered crops and plants under its general authority to regulate plant pests, and reviews requests to “deregulate” the crop or plant, which, if granted, allows it to be grown without a permit at a commercial scale.
View a full report on the regulation of Synthetic Biology, provided by the J. Craig Venter Institute
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EPA regulates genetically engineered microbes as “new chemical substances,” as well as regulates genetically engineered pesticides (including biopesticides and pesticides incorporated into plants) under its authority to regulate pesticides. FDA regulates products that fall under its broad authority to regulate food, food additives, human and animal drugs, and certain other products, such as those that have been produced through genetic engineering. Each agency has developed regulations and guidelines to help implement its authority (3.11, 3.12).