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Team:Paris/EthicalReportBiosafetyBiosecurity
From 2009.igem.org
Biosafety and biosecurity concerns
In the first part of our analysis, we will focus on biosafety and biosecurity problems, a primary concern surrounding synthetic biology. Our analysis is based on the synthesis of arguments from a heterogeneous literature. Thus, as stated in the introduction, we must try to take into account the polyphony of ethical discourses. By reading these papers, we can find a homogeneous ensemble of arguments and warnings, showing that homogeneity could happen even in polyphony, when every social actor has the same interest, creating an invisible and informal consensus. We will use the evaluations of Vivagora, a French intellectual association that studies the stakes of biotechnologies, the ethical report Life to Lego of the Delft University of Technology (TU Delft) in Netherlands for IGEM 08, two monitoring strategical reports from French State (Note de veille stratégique) and the European Union (through the Synbiosafe initiative) and the paper A Synthetic Biohazard Non-proliferation Proposal by George M. Church, professor of genetics at the Harvard Medical School.
Biosafety and biosecurity are neologisms build to express new forms of alerts against risks linked to technologies of contemporary life sciences. Biosecurity's reflexions focus on “biologic accidents”, involuntaries, unexpected consequences of certain scientific handling. Through these “bioerrors”, for example, we can think about the involuntary release of a synthetic organism into the environment, or the unexpected production of toxins or pathogenic agents by an organism that was thought to be under control. Biosecurity is about risks posed by a malicious mind, a person who wants to harm. That threat is embodied in the “social part” of the bioterrorist. The “subjects”, centers of interest of biosecurity and biosafety are also what justified their common analysis. Health, regarding human, and environmental concerns, regarding “non human”, are at the heart of the ethical perspective we will perform. Biosecurity and biosafety are very present in the synthetic biology literature and that presence can be read under the light of M A Hermitte’s explanations about the fact that, in our society of science and technologies, both promises and anguishes are formulated at the same time.
Both kind of risks can be divided and connected through two concepts : malice and failure. In the texts we studied, we found the main distinction between these concepts to be the identification of the person who is at the origin of the action (the scientist and the terrorist) and the nature of his intentions, his wills. We have to notice that failure is attached to scientific work and is opposed to the malice of the terrorist will. Intentions, errors or “harming will”, in ethical reflexion, are substitutes for other concepts that we usually use to distinguish “terrorist” and “scientist”. Thus, “knowledge”, “work” or other social aspects are not present here. We do not distinguish these cases by their intellectual and handling capacities but by their intentions. Even worst, the scientist seems to undergo, in that portrait, natural unpredictability and errors while voluntary procedure of the terrorist seems to confer him a better relation to knowledge, at least more efficient. Failure is related to the scientific handling while success is related to the terrorist perspective. That point is quite risky for the social perception of synthetic biology, “essentializing” the discipline in a dangerous light, success being easier when you want to hurt others. It also leads us to consider the democratization of knowledge in new disciplines of life science. That kind of insignificance of knowledge represents the fact that is not the main distinction anymore : everyone can have knowledge of the life sciences, it is not a principle of distinction anymore. That point entertain the risks perception : for example, the fact that Roger Brent, Director of Molecular Science Institute of Berkeley, estimates that 100,000 peopele are able to create their own anthrax is a very frightening argument, encouraging critics of that democratization process. The last element we can get from that analysis is the new mythical construction of the social aspects of our protagnists, the scientist and the terrorist. I use the “mythical” word to refer to the cultural influence of sciences in the construction of the way we perceive the world and the social agent. Thus, in the theoretical perspective of philosophers such as Donna Haraway, we can draw the mythical figures that seem to embody a part of western culture frightened about the uncontrolled holder of knowledge. The social figure of the terrorist and the scientist can be considered under that light. That new cyborg figures, hybrids of promises and threats, products of our techno-scientific, post-industrial and western societies.
- 1) Questioning biosafety matters?
In parallel with that new cultural construction of the protagonists of knowledge, as Synbiosafe points out, an ethical perspective will have to succeed in a new challenge for risks perception.
« In traditional genetic engineering the risk assessment is based on the donor organisms. Most transgenic organisms so far contain genes from relatively few parental organisms. In synthetic biology, however, the situation changes because organisms can be created with a large number of genetic donors or even without any natural templates at all. Also instead of changing only few genes, with synthetic biology we will be able to create completely new genetic networks without known counterparts in nature. Given the absence of natural templates as a basis for solid evaluation, how can a risk assessment be carried out under such circumstances? »
Synbiosafe, Background Document Pages 5-6
Is other words, are we able to integrate the techniques and technologies that are performed in synthetic biology with our social devices of risks prevention?
- What are the biosafety problems?
What are these problems? How are they formulated in our lectures? A set of problems can be drawn, we'll try to justify it in the more complete and concise way.
To introduce our point, we will refer to a question asked by the Synbiosafe report, wondering about risks in the perspective of the “rejection of novelty”. The Synbiosafe report wonders about reliance on new protocols in order to answer to the new risks when some people say that nothing is new in synthetic biology, referring to risks in life science in general. The European initiative retaliates to those critics, underlining the contradiction of their purpose : how can we promote such “novelties” in synthetic biology and, in the same time, claim that nothing new is happening about risks?
Discourses we are about to analyze, in the preventive dynamic of the ethical reflexion, have to be thought of in the stages upstream of the incident and challenged to find “efficient answers” even if problems are not yet present to us.
- How to evaluate risks?
As already mentioned, risk evaluation seems to be a necessary preliminary step to any satisfying ethical reflexion. Are we able to understand the stakes? Through what means and what formulations?
One of the new ways to perceive ethical stakes can be find in the TU Delft ethical report, by mathematizing the analysis of the risks.
« When making a decision, like the decision whether or not to use Synthetic Biology in an application, one balances the risks against the benefits. But is actually meant by “risk” isn’t always clear. Textbooks state that the Risk is the magnitude of the Hazard when it takes place, multiplied by the Frequency in which these hazards actually occur (R = H * F). These risks are partially factual risks, which can be scientifically assessed, like assessing the chance that an organism will share DNA with surrounding organisms upon deliberate release into the environment. There are also virtual risks, like exploring the probability of creating a biological weapon with open source BioBricks. When the future impact of a certain decision, like in the case of using Synthetic Biology in increasing levels of artificialness, risk assessment actually becomes risk perception: the response of the public, NGOs or consumers are unknown, as well as the scientific possibilities and application areas. If the risk is “low enough” (and one has to wonder who decides that), a certain action can be justified. Some would calculate the Justification of a decision as the Impact of something going well, times the Chance of it going well, minus the actual risk (J = I * C – H * F). »
That pragmatical perspective create a balance between possible risks and benefits of an application, putting that balance in the moment of the design of that application. After that demonstration, the author of the report has to concede its limits, mainly in the arbitrary choice of the variables. Degrees of certainty and strategical variability in the position of the social actor through the evaluation of risks also has to be taken into account. Thus, an NGO working on biotech risks will develop a more alerted position than a genomic laboratory. It can be interesting to notice, through this light, the importance of the variability of defended positions about risks and solutions, depending on the strategies of actors.
- The intuition of “nature”
The work of the french association Vivagora enriched our approach about discourses on biosafety by referring to nature. What can we do about unexpected mutation of an organism in the environment? What can we do if a laboratory fails in containment and that a pathogenic agent escapes? Before that, Synbiosafe alerts us about the fact that environmental propagation is, sometimes, the main aim of an application, in particular about green and depollution application. Environmental biosensors need to be deliberately introduced into environment. Facing the weak capacities to evaluate risks, how can we be assured that the synthetic organism will succeed in the task it was designed for and no others? How can we control its behavior?
Through that variability that handicap us, Vivagora adds a fixed element, something solid we can hang on to : the natural dynamics that determines all organisms, evolution. The theoretical and paradigmatical base of the theory of evolution in life science seems to impart it with enough authority to be the element needed to fix risk evaluation. Thus, we can be sure that any organism is about to mutate and propagate in an adaptation process to its environment. Precaution linked to that point is then attached to the concept of control. Development, mutations and other kinds of evolutions of a synthetic organism has to be controlled. That control, however, has to be done through means of synthetic biology. Synthetic biology is thus able to answer autonomously to its own stakes. That control has to be faced from the beginning of a project, in the design of the application, to prevent the match with environment. Thus, precaution is at the heart of that process : from the formulation of the ethical risks to its material and biological answer.
- Biosafety and biosecurity : a differentiated focus.
In reference to its institutional membership with the European Commission and in a strategic perspective, the Synbiosafe report relates an interesting element about the formulated ethical stakes in synthetic biology. The report draws a gap between American and European interests about ethical stakes about biosafety and biosecurity. Europe is said to be more interested in biosafety matters and that the USA is more concerned about biosecurity problems. The report asked, in that reflexion, the more strategical and political question of it : “Will synthetic biology deepen the transatlantic divide opened up during past biotech debates?”. We won't go deeper into that point but we can notice the geopolitical stakes of biotechnologies that can come with ethical questions. Governance and political strategies that occur with the precautionary approach has to alert us about different motivations of the ethical debates on biosafety and biosecurity.
- 2) Answers
What kind of answers are proposed or brought by our actors?
- Biological answers with social faces
Vivagora doesn't defend any position but portray proposals from different researchers. Thus radical modification of organisms is proposed to make them unable to survive into the wilds and to cross with other species. It is the idea that “the less natural will be our production, the less they will be risky”. How to perceive that proposal? The internal logic of that idea, that more synthesis will lead to more security isn't a refuge in denial of risks? Regarding unknown evaluation of risks about the reaction of a mutated organism in a natural environment, can we trust our intuition about the security of a parallel system? How can we be ensured of the non-reaction of the organism, even the “less” natural? What if the mutation, despite all, happens, what will be our means of action? The prevention and “upstream” alerts of ethical perspectives don't seem to be satisfied by the same adjectives. Thus, uncertainty about risks coming with a preventive approach is reassuring but, that reassurance isn't coming with the uncertainty of answers.
Synbiosafe mentions the proposal of a parallel biological system which won't interact or exchange with other organisms. The European initiative refers to a “unconventional” biosafety system, through the idea of “high external control” in which the conditions and possibilities of existence of the organism will be controlled and determined by man.
The French page of the wikipedia encyclopedia relates that argument in an other nomenclature, referring to “three kinds of safety bolt” to answer to the issues of containment.
- 1.“Trophical containment (or nutritional) : is about creating an organism needing rare or naturally unknown substances to survive (artificial vitamins)”
That mode of containment seems to correspond to the “high external control” proposed by Synbiosafe.
- 2.“Evolutional containment : it is about creating modified organisms, recombinant (for example, “reprogrammed” bacteria conceived to be unadapted to autonomous survival in nature. In order to reduce production costs, it is already easy to produce massively new recombinant and reprogrammed organisms with no natural equivalent. If they are very different and highly altered, they have little viability in a natural environment. Using that type of organism, said loser (for example “weaker” bacteria so few are competitive against “natural” forms, so that they survive only if they are cultivated in optimal conditions and artificially maintained by man). This is a form of security of the device, but it implies maintenance costs of the habitat and of the colony. Philippe Marlière notices that it is enough, then, to submit that mass of organisms to a new kind of natural selection process in order to select individuals and strains more suited to survive (which is possible with some bacterias because of their high rates of reproduction). But, that solution asks once again the question of risk of escape in the natural strain of an organism or of an genomic part which became competitive, even “supercompetitive” (said winner).”
We have to stop here for a while, certifying that evolutionary containment corresponds to that “fail fast” solution already mentioned. Remarks made in wikipedia to that device are close to ours.
It is also interesting to notice that, into the light of natural selection and the theory of evolution, a new surprising lexicon is entering the game. Synthetic organisms are qualified as winner and loser depending on their capacities of adaptation. The notion of competitiveness enlightens the application of a manager to biological phenomena. Moreover, it is important to note that our preventative approach leads us to fear for that competitiveness. Thus, the winner bacteria causes us to fear, while the loser bacteria stays within our ethical specifications. Vocabulary and lexicon used seem to be both ethically problematic and socially representative of new criteria of evaluation and the way to express it in contemporary life sciences. Like the liberal manager without a qualm in a system of concurrency (the social winner), bacteria will scare us but, through that lexicon, also becoming something that deserves our respect, because of the development of its aptitude. The use of a socially situated lexicon is no novelty in life science, as shown in Evelyn Fox Keller and Emily Martin's works about the influence of explanatory metaphores in biology. Emily Martin focused about how metaphores about egg and sperm roles in the reproduction process have an important social impact about our perception of man and women.
- 3.Semantic containment ( about genetics, changing of codons). We also consider with classical GMOs to build organisms programmed to commit suicide or to not be able to reproduce (for example, terminator genes or inhibition of reproduction).
The French page of wikipedia remind us that noon of the three “bolts” offer “certain, definitive or complete protection”, but that has to be considered all together to get to a high level of security.
- 3) Protocols to fight hazard
George M Church’s article, A Synthetic Biohazard Non-proliferation Proposal, is surprising in its aim and representative of a certain spirit of synthetic biology. This more academic source does not go through material modes of containment and biological systems of security. It proposes, in a very precise way, to set up an ensemble of procedures of control that are more or less institutional, to create a series of agencies, administrative protocols and organisms of regulation in order to “decrease risks while minimizing impact on legitimate research”. Thus, a licensing system of reagent and instrument is proposed, as “non-profit or government DNA Instrument & Reagent Registry (DIRR) database and web site would allow manufacturers and customers to register their instruments”. A chain of checking and responsibilities is described, from the seller to the customers, through entities as States, manufacturers and distributors of agents, shipping companies, etc. Registers, websites and databases are also presented as needed to manage “existing machines, the resale of used machines and confirmed destruction of machines.” Checking methods as developed by the Drug Enforcement Agency are promoted. That precision and proceduralization in the aim to answer to security imperatives is well described in the article and we won't reproduce it in detail here. But, we must wonder about that proceduralization. Two explanations seemed important to us. The first is about the structure of production in modern life science. Scientists in that field, especially Americans, have to answer to strict security specifications about biological materials needed for their research and handling. Thus an administrative “machinery” is admitted as legitimate, integrated in the scientific process andused daily by researchers. That habits of scientists, in their ordering of biological materials or in their conceptions of necessary conditions of security, will determine their ethical discourses and recommendations. The other explanatory element I found in that article is the reassuring fact which can be found in the procedural, even bureaucratic, conditions to make synthetic biology. Thus, we can see here the expression of a “engineering mind”, expressed in rationality in that procedural form of the system of production and exchange in life science.
