Our interactive GLP global map explains the status of each country’s regulations for human and agricultural gene editing and gene drives.
Anti-GMO Advocacy Funding Tracker
This GLP project maps contributions by foundations to anti-biotech activists and compares it to pro-GMO industry spending.
Synthetic biology is an emerging field focused on engineering new biological systems that do not already exist in Nature or redesigning existing systems from scratch. Scientists are working to build new life forms, assembling them from their fundamental chemical components. They are trying to use biotechnology to produce substances that are difficult to obtain by other means—medicines and fuels, in particular. Because synthetic biology brings together so many disciplines, some have hailed it as the genesis of the next Industrial Revolution.
Synthetic biology combines chemical synthesis of DNA with growing knowledge of genomics to enable researchers to quickly manufacture catalogued DNA sequences and assemble them into new genomes. It has the potential to contribute to addressing grand societal challenges, such as in health care, environmental sustainability, scarcity of resources and energy security. But like any other innovations, synthetic biology is not without scientific risks. In addition, it may raise ethical and religious questions and concerns, since it allows mankind to put ‘life’ and ‘nature’ on the drawing board like never before.
“At its core,” writes Jacob Brogan in Slate, “it’s all about the selective assembly of genetic information. This is where the connection with computer science comes into play. Synthetic biologists aren’t just copying and pasting existing DNA from one place to another—they’re looking to figure out how specific sequences work and then putting them together into new configurations. The idea is that you can figure out what given segments of DNA [sometimes described as BioBricks] do and then patch them together, much as you would with lines of computer code, effectively programming cells to behave in new ways.”
In theory, there are all sorts of things scientists who are expert in synthetic biology could build from BioBrick components, but in practice it’s incredibly hard. It’s such a new field that there is very little that’s come to market yet that’s specifically from what could be termed synthetic biology, although the lines between genetic engineering and synthetic biology are blurred.
Industrial biotech scientists and companies have been utilizing forms of synthetic biology for years, including gene splicing, metabolic engineering and directed evolution. Microorganisms that are engineered are used in closed fermentation vats to produce the end products desired. Improvements in the speed and cost of DNA synthesis are enabling scientists to design and synthesize modified bacterial chromosomes that can be used in the production of advanced biofuels, bio-products, renewable chemicals, bio-based specialty chemicals (pharmaceutical intermediates, fine chemicals, food ingredients) and products in the health care sector as well.
Scientists have studied the genomes of microbes to identify biological processes that can replace chemical reactions to make new products, cleaner manufacturing operations, and reduce the number of production steps. For example, by harnessing the natural power of enzymes or whole cell systems, and using sugars as the feedstock for product manufacturing, industrial biotech companies can work with nature to help us move from a petroleum-based economy to a “bio-based economy.”
In 2010, scientists at the J. Craig Venter Institute (JCVI) announced the world’s first synthetic life form; the single-celled organism based on an existing bacterium that causes mastitis in goats, but at its core is an entirely synthetic genome that was constructed from three chemicals in the laboratory. The single-celled organism has four “watermarks,” written into its DNA to identify it as synthetic. It took the Venter Institute 15 years to complete this initial project.
In 2013, a start-up promising to make glowing plants went on Kickstarter where it successfully raised $500,000. The promised engineering miracle never materialized, underscoring synbio’s technical challenges. The company now makes fragrant moss, and is still trying to address the technical challenges of making plants glow.
There have been some fantastical suggestions about combining tools from gene editing, cloning and synthetic biology to resurrect extinct species, such as the wooly mammoth. De-extinction would require collaboration from a number of different disciplines, connecting geneticists, molecular biologists, synthetic biologists and conservation biologists.
Genetically enhanced microbes (GEMs) are regulated by the Toxic Substances Control Act. The overall field of synthetic biology remains largely unregulated, however. According to Slate, proponents of synthetic biology will tell you that we’ve been playing with genetics since the dawn of agriculture—and that new technologies simply allow us to do so with greater precision, care, and understanding.
The bigger issue may be that there aren’t clearly defined regulatory standards for synthetic biology. Drug and food safety regulations can still apply, but that’s mostly about how products created through these studies make their way to market—which is a long way off for most work in the area. Researchers have laid out possible regulatory models, but for now most norms are informal, if they exist at all.
An array of anti-biotechnology NGOs have demanded bans or sharp limitations on the emerging technology. In March 2012, over 100 environmental and civil society groups, including Friends of the Earth, the International Center for Technology Assessment and the ETC Group issued the manifesto, “The Principles for the Oversight of Synthetic Biology.” They called for a worldwide moratorium on the release and commercial use of synthetic organisms until more robust regulations and rigorous biosafety measures are established. The groups specifically called for an outright ban on the use of synthetic biology on the human genome or human microbiome.
Groups largely skeptical of biotechnology, such as the Center for Genetics and Society, wrote approvingly of the recommended restrictions, arguing for an imposition of the ‘precautionary principle,’ while industry groups and many scientists expressed concerns about attempts to heavily restrict a nascent technology. In 2009, a report by the Hastings Society, an independent bioethics think tank, argued for striking a balance between precaution and a “proactionary” stance that would try to fast track the science. A 2010 report from the Presidential Commission for the Study of Bioethical Issues struck a somewhat similar stance by endorsing “prudent vigilance,” which the PCSBI said was “a middle ground” between halting the field entirely and “letting the science rip,” regardless of the likely risks.