Past Activities 2015-2016

Once again, it is a privilege to have access to a big collection of important views, opinions and recommendations about Synthetic Biology, from a broadly-distributed group of specialists. Many thanks for that.

It is very important to  keep Synthetic Biology and the fast advances still to come, as a natural part of the evolutionary human activity where Technology ( as expressed by Kevin Kelly ) coevolves.

The term "Potential" is better applied to Risks, since there is no "obligation" for a new knowledge or technique to come always in favor of Biodiversity. Obviously, more we know about impacts, more we will be able to repair, remediate and even evitate a new development.

However, the history of Genetics and Improvement is one of the richest evidences about the REAL benefits of these human developments. In this sense, the contributions of the biotechnology techniques, as well as the contributions of genomics and the so-called Synthetic Biology (I have already expressed my preference for Artificial Biology & Artificial Intelligence, since this is the very foundation of a new era for humankind ) should be taken as a continuum of all the previous history of Genetics and Improvement.

To assume that Genome Editing techniques would add unprecedent -  dangerous -  unknown mutations etc,  obliges the reader to revisit all the unknowns of backcross breeding, mutation breeding etc , as well as to remind  all the black swans and genies-out-of-the bottle that Nature and Evolution continuously introduce, as infections, epidemies, species extinction etc.

I consider that all the contributions in favor of a case-by-case risk analysis and risk assesment should be taken in consideration as a logic way to balance benefits and risks, and then I support Drs. Shirae, Dannenberg, Tzevetkov, Ambrozevicius, Glandorf, Batic.

As per economic analysis, we should not put Science & Technology against Economy; a logical strategy would be to respect the main mandate of the CP in terms o case-by-case analyses, keeping in mind that any country in its sovereignity is allowed to proceed with economical analysis, as appropriate. I acknowldege the contribution of Dr. Dannenberg for its excellent description of the real benefits of Synthetic Biology.

I am sensible to all the many struggles, needs and aspirations of ILCs. However, to insist with the synthetic vanillin  as a negative business case that should be taken as a reference of social damage arising from Synthetic Biology is to try to rewire the human  society's economical history.
It is evident that this new era of the Biochemical Industry will require from public and governmental instances a continuous dedication to social development and socio-economic sustainability, as any other technological improvement in human history.

Unfortunately, the global history is plenty of examples where, despite the availabilty of techonological advances, other instances keep ILCS in bad condition. The power of Technology is available, but the power of politics and greed frequently prevail.

Wish you all the best,

Joaquim A. Machado

Thank you to the organizers of the Forum for the initiative so interesting discussion. I would like to strongly support the manifestation of Dr. Machado. The introduction of a organism in a specific environment probably will be cause some impact. Conventional plant breeding, for example, has produced numerous varieties of plants that are grown in large scale and produce various effects on components of an ecosystem.

The relationship between a synthetic organism and biodiversity seems to be rooted by the novelty of a genome present in the environment, without so a biological history and possible interactions verifiable as in a conventional organism. Genetically modified organisms use donor genes already known.

Unlike conventional organisms, engineered organisms are used by an ex ante risk assessment to its release. The risk assessment have been incremented with information provided by development of scientific knowledge as well as processing techniques and high-precision instruments computer. Considering this last point, the synthetic organisms already have computing programs that allowing design synthetic components, topology / network design biochemical, behavioral simulation and prediction. This elements can already be considered the beginning of an area of "digital ecology," a strong ally of molecular ecology. Both segments are priorities for elucidating environmental interactions / biodiversity of synthetic organisms and are essential for this task. The in silico modeling is an important study interactions channel for synthetic organisms and represent a significant difference in risk analysis phase.

The use of a synthetic organism is recommended by stages very similar to that of a genetically modified organism using nucleic acids cloned. Risk Assessment methodologies may be perfectly applied to a synthetic organism

My name is Dana Perls, with Friends of the Earth, U.S. I appreciate reading everyone’s comments, and would like to highlight a few concerns.

First, I would like to echo the concerns of Dr. Smolker about the process. While it is critical to have a diversity of stakeholder participation, it is our responsibility in this forum is to name and discuss the potential impacts and risks, and to support a precautionary approach, one of the fundamentals of the CBD, enshrined in the paragraph of the Preamble to the Convention and repeated in relation to synthetic biology in Paragraph 4 of Decision XI/11 and reaffirmed in Decision X11/24. This means it is precisely the potential impacts – and particularly the threats-- that we must address. Inherent in this is the need to have a process in place to evaluate and address the potential problems for when they may come to be a reality. I note this because several industry representatives have been downplaying environmental and societal concerns and suggesting that because they are potential risks, or perhaps “hypothetical”, there may be no need for concern. In fact, this is in direct conflict with a precautionary approach and the request from Decision XII/24. This is not a space to defend company products, but to be focused on addressing all risks and potential benefits of synthetic biology objectively, and ensure that private financial interests do not conflict with this objective process.

Secondly, I would like to reemphasize points that several others have made about the risk of environmental escape. Some have argued that there are contained systems and therefore no risk of escape. However, no containment is 100%, particularly those that become air or waterborne as mentioned by Dr. Smolker. In fact, we have already seen escape of synthetically engineered organisms from supposed “contained” biorefineries (for example, the spills from Amyris Inc’s Brazilian facility, as reported by the company to the regulators.) The escape of organisms engineered via synthetic biology into the environment – either intentionally or otherwise – could have serious and unforeseeable consequences, including genetic contamination of wild species, disruption of natural ecosystems and release of chemical and biological pollutants.

Although some government representatives have mentioned regulations that may address aspects of LMOs, none of the regulations and systems described seem fully adequate for monitoring or evaluating the impacts of synthetic biology on ecosystems or biodiversity. These are not regulations that can be done on a case-by-case basis, particularly given the quickly increasing number of commercial engineered organisms being developed and the Do-It-Yourself synthetic biology community that is rapidly growing. It is not realistic to assume that any government agency would have the capacity for a case-by-case evaluation without some strong common standards on regulation.

As I remarked in my earlier comments, increased demand for feedstocks to feed synthetic biology organisms could impact critical ecosystems and biodiversity. The collective development of synthetic biology organisms that depend on feedstock, ranging from flavors and fragrances for food, to chemical production, to oils for biofuel, could lead to massive changes in land use, impacting the food and water supply. Increased demand for biomass to produce biofuels through synthetic organisms will add even more pressure on soils, water resources and ecosystem integrity. The harmful impacts of pesticide use in agriculture to product sugar cane, corn, and other common sources of sugar, are well documented, and will be exacerbated as demand for feedstocks increases.

I’d like to reemphasize that synthetic biology “nature equivalent” products could displace sustainable small farmers and producers, having enormous socioeconomic impacts. Although the public relations director for Evolva, Mr. Herrera, disputed that his company’s vanillin product would have a socioeconomic impact on small farmers, (a position which Friends of the Earth disagrees with), we are not here discussing one particular product, but the hundreds of botanical sources like saffron, stevia, and agarwood, that, unlike vanilla, do not have special laws protecting how they are labeled. While synthetic biology vanillin may not be labeled as “natural vanilla” because of special standard-of-identity laws for vanilla, products incorporating this synthetic biology ingredient could be labeled as being made with “natural flavors” or with “vanillin from a natural source”. The company Evolva, for example, has consistently defended its right to append a “natural” tag, despite the highly unnatural production.  So-called 'nature equivalent” products like stevia or saffron do not special laws pertaining to them, and could in fact be labeled as “natural”, and are being priced competitively with the truly natural botanical sources, not the synthetic sources.

We need to not be narrowly focused on particular products, as some industry representatives have suggested, but look objectively, and with a strict precautionary approach, at the potential combined and individual impacts of all the thousands of synthetic biology applications that companies are proposing for commercialization, including flavors, fragrances, medicines, oils, and more, and particularly, the combined impact of synthetic biology overall.
Thank you to everyone for the rich discussion.

Kind regards,
Dana Perls

Dear participants, my name is Stephan Herrera. I work at a small, Swiss-based biotech called Evolva that leverages synthetic biology and fermentation to brew ingredients that would otherwise be sourced from petrochemicals, endangered plants and animals, or from industrial-scale croplands.

In addition to Switzerland, we have operations in Denmark, the UK, India and the US. We are young (just over 10 yrs old). We are small (we employ ~ 150 people, most of them PhD scientists). We are not rich (like most biotechs, most of our products are still in development, so our revenues are modest and our profits somewhere on the horizon). We are not powerful, but we do have some influence in industry.

We do not simply talk about the need for our industry to be open and transparent, to be mindful about responsible innovation, or to engage with ALL stakeholders. We try to lead by example. Our commitment to the CBD, and this particular phase of its focus on synthetic biology risks and benefits, is not as Ms Perls implies about public relations (btw: we do not have a public relations director, nor do we have a PR agency or lobbyist on retainer) or posturing for our backers. There are those who have figured out how to extract PR value and posturing points from Evolva's presence in the CBD community and at COP/MOP meetings and side events, but I can assure you that I am not one of them.

Nobody is saying that synthetic biology is a silver-bullet technology platform capable of single-handedly mitigating all of the stressors that are currently impacting biological diversity such as climate change, invasive species, deforestation and habitat loss. But, as a former reporter who spent nearly 20 years covering science, business and politics of alternative energy, healthcare, and biotechnology innovations, I see in synthetic biology and fermentation an exquisitely well suited platform whose potential to do good vastly outweighs any risks that come with it. This is not to say that this platform will perform equally well in all applications. It won't. Nothing does. But, if history has taught us anything it is that large, complex problems (including those such as stressors on the world's biodiversity) require a full spectrum of solutions. There are many efforts around the world devoted to teasing out the extent to which these solutions could/should include synthetic biology. History has also taught us that nothing is risk-free, which is why synthetic biology has for many years now already been dissected, studied, and deeply pondered.

We are no closer to achieving the Aichi Targets or implementing solutions for climate change, invasive species, deforestation and habitat loss. So, while efforts here in the CBD to define and then try to achieve consensus on what qualifies as acceptable vs unacceptable risks stemming from synthetic biology are certainly expanding the canon, let us not to forget that we are not the first to go down this path.

Indeed, as we push forward in our quest for greater clarity and wisdom on the risks and benefits synthetic biology, let us not forget that there are already a number of studies and reports that have already measured many of the same angles that lie before us in this forum. Some of these publications were commissioned by governments, others by non-profits. Views from the public, scientists, engineers, government officials, regulators, risk assessment specialists, industry, and NGOs were solicited and considered. A broad swath of commercial and research applications were considered from food ingredients and medicines to fossil fuel alternatives and palm oil replacements. 

In addition to the knowledge and clarity that can be gained from reading these reports, there is much to learn from the synthetic biology content created and curated at the Wilson Center, Public Research and Regulation Initiative (PRRI), and Forum for the Future.

http://www.wilsoncenter.org
http://www.prri.net/synthetic-biology/
http://www.forumforthefuture.org

Finally bringing this overly long-winded missive to a close, I need to inject more fact-checking clarity to what Ms Perls writes about our saffron and stevia. They fact is that they are not on the market. So, not only are they not "priced competitively with the truly natural botanical sources, not the synthetic sources", they are not priced, branded, positioned, or even available.

Sincerely,
Stephan Herrera
VP, Strategy & Public Affairs
Evolva
http://www.evolva.com